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The following is an excerpt from a 10-K SEC Filing, filed by HALSEY DRUG CO INC/NEW on 3/31/1999.
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ACURA PHARMACEUTICALS, INC - 10-K - 19990331 - PART_I

PART I

ITEM 1. BUSINESS.

GENERAL

The Company, a New York corporation established in 1935, and its subsidiaries, are engaged in the manufacture, sale and distribution of generic drugs. A generic drug is the chemical and therapeutic equivalent of a brand-name drug for which patent protection has expired. A generic drug may only be manufactured and sold if patents (and any additional government-granted exclusivity periods) relating to the brand-name equivalent of the generic drug have expired. A generic drug is usually marketed under its generic chemical name or under a brand name developed by the generic manufacturer. The Company sells its generic drug products under its Halsey label and under private-label arrangements with drugstore chains and drug wholesalers. While subject to the same governmental standards for safety and efficacy as its brand-name equivalent, a generic drug is usually sold at a price substantially below that of its brand-name equivalent.

The Company manufactures its products at facilities in New York and Indiana. During the last several years, the Company has sought to diversify its businesses through strategic acquisitions and through the development, manufacture and sale of bulk chemical products used by others as raw materials in the manufacture of finished drug forms.

RECENT EVENTS

Regulatory Compliance

During the past several years, the Company's business has been adversely affected by the discovery of various manufacturing and record keeping problems identified with certain products manufactured at its Brooklyn, New York plant. In October 1991, the U.S. Food and Drug Administration (the "FDA") placed the Company on the FDA's Application Integrity Policy list and its restrictions (collectively, the "AIP"). Under the AIP, the FDA suspended all of the parent company's applications for new drug approvals, including Abbreviate New Drug Applications ("ANDAs") and Supplements to ANDAs. During the period that followed, the U.S. Department of Justice ("DOJ") conducted an investigation into the manufacturing and record keeping practices at the Company's Brooklyn plant. As a consequence, on June 21, 1993, the Company entered into a plea agreement (the "Plea Agreement") with the DOJ to resolve the DOJ's investigation. Under the terms of the Plea Agreement, the Company agreed to plead guilty to five counts of adulteration of a single drug product shipped in interstate commerce and related record keeping violations. The Plea Agreement also required the Company to pay a fine of $2,500,000 over five years in quarterly installments of $125,000 commencing in September 1993. As of February 28, 1998, the Company was in default of the payment terms of the Plea Agreement and had made payments aggregating $350,000. On March 27, 1998, the Company and the DOJ signed a Letter Agreement serving to amend the Plea Agreement relating to the terms of the Company's satisfaction of the fine assessed under the Plea Agreement. The Letter Agreement provides, among other things, that the Company will satisfy the remaining $2,150,000 of the fine through the payment of $25,000 on a monthly basis commencing June 1, 1998, plus interest on the outstanding balance. See "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations -- Liquidity and Capital Resources" for a more detailed description of the Letter Amendment to the Plea Agreement between the DOJ and the Company.

On June 29, 1993, the Company entered into a consent decree (the "Consent Decree") with the U.S. Attorney for the Eastern District of New York on behalf of the FDA that resulted from the FDA's investigation into the Brooklyn plant's compliance with the FDA's Current Good Manufacturing Practices ("CGMP") regulations. Under the terms of the Consent Decree, the Company was enjoined from shipping any solid dosage drug products (i.e., excluding liquid drug formulations) manufactured at the Brooklyn plant until the Company established, to the satisfaction of the FDA, that the methods used in, and the facilities and controls used for, manufacturing, processing, packing, labeling and holding any drug, were established, operated, and administered in conformity with the Federal Food, Drug, and Cosmetic Act and all CGMP

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Regulations. As part of satisfying these requirements, the Company was required to validate the manufacturing processes for each solid dosage drug product prior to manufacturing and shipping the drug product.

On October 23, 1996, the Company withdrew four of its ANDAs, including its ANDA (the "Capsules ANDA") for acetaminophen/oxycodone capsules (the "Capsules"), and halted sales of the affected products. Net sales derived from the withdrawn Capsule ANDA were approximately $3 million and $8 million for the years ended December 31, 1996 and December 31, 1995, respectively, and accounted for approximately 24% and 40% of the Company's total net sales during such twelve month periods. The Company instituted the withdrawal of the Capsule ANDA at the suggestion of the FDA and in anticipation of its release from the AIP. At the FDA's suggestion, the Company retained outside consultants to perform validity assessments of its drug applications. Thereafter, in October 1996, the FDA recommended that several applications, including the Capsule ANDA, be withdrawn. As a basis for its decision, the FDA cited questionable and incomplete data submitted in connection with the applications. The FDA indicated that the withdrawal of the four ANDAs was necessary for the release of the Company from the AIP. The FDA further required submission by the Company of a Corrective Action Plan, which was prepared and submitted by the Company and accepted by the FDA.

On December 19, 1996, the FDA released the Company from the AIP. As a consequence, for the first time since October 1991, the Company was permitted to submit ANDAs to the FDA for review. Since its release from the AIP in December 1996, through the fiscal year ended December 31, 1998, the Company submitted 13 ANDAs for review by the FDA, including a new ANDA with respect to the Capsules. During the period from the Company's release from the AIP to March 15, 1999, the Company received the following ANDA approvals, all of which relate to ANDA filings made with the FDA subsequent to the Company's release from the AIP:

PRODUCT NAME
(DRUG CLASS)                     STRENGTH      TRADE NAME                STATUS
------------                    -----------   -------------   -----------------------------
Hydrocodone Bitartate and.....  5mg/500mg     Vicodin(R)(1)   FDA approval of ANDA received
  Acetaminophen Tablets                                       September 26, 1997.
  (narcotic analgesic)
Hydrocodone Bitartate and.....  7.5mg/750mg   VicodinES(R)(1) FDA approval of ANDA received
  Acetaminophen Tablets                                       September 26, 1997.
  (narcotic analgesic)
Hydrocodone Bitartate and.....  7.5mg/650mg   Lorcet          FDA approval of ANDA received
  Acetaminophen Tablets, CIII                 Plus(R)(2)      November 26, 1997.
  (narcotic analgesic)
Hydrocodone Bitartrate and....  10mg/650mg    Lorcet(R)(2)    FDA approval of ANDA received
  Acetaminophen Tablets, CIII                                 November 26, 1997.
  (narcotic analgesic)
Oxycodone HCI and.............  5mg/50mg      Tylox(R)(3)     FDA approval of ANDA received
  Acetaminophen Capsules, CII                                 January 22, 1998.
  (narcotic analgesic)
Oxycodone HCI/Oxycodone.......  4.5mg/325mm   Percodan(R)(4)  FDA approval of ANDA received
  Terephthalate Tablets, CII                                  July 24, 1998
  (narcotic analgesic)


(1) Registered trademark of Knoll Pharmaceutical Co.

(2) Registered trademark of Forest Laboratories, Inc.

(3) Registered trademark of McNeil Consumer Products Company

(4) Registered Trademark of DuPont Merck

As of March 15, 1999, the Company had submitted one ANDA for review by the FDA in fiscal 1999 and anticipates the submission of five additional ANDAs during the balance of fiscal 1999. Although the Company has been successful in receiving the ANDA approvals described above since its release from the AIP in December 1996, there can be no assurance that any of its newly submitted ANDAs, or those contemplated to

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be submitted, will be approved by the FDA. The Company will not be permitted to market any new product unless and until the FDA approves the ANDA relating to such product. Failure to obtain FDA approval for the Company's pending ANDAs, or a significant delay in obtaining such approval, would adversely affect the Company's business operations and financial condition.

Private Offerings and Bridge Financing

On March 10, 1998, the Company completed a private offering of securities (the "Offering") to Galen Partners III, L.P., Galen Partners International III, L.P., Galen Employee Fund III, L.P., (collectively, "Galen") and each of the Purchasers listed on the signature page to a certain Debenture and Warrant Purchase Agreement dated March 10, 1998 between the Company and such Purchasers (inclusive of Galen, collectively the "Galen Investor Group"). The securities issued in the Offering consisted of 5% convertible senior secured debentures
(the "Debentures") and common stock purchase warrants (the "Warrants")
exercisable for an aggregate of 4,202,020 shares of the Company common stock. The net proceeds to the Company from the Offering, after the deduction of related Offering expenses, was approximately $19.6 million. In addition, in accordance with the terms of the Debenture and Warrant Purchase Agreement pursuant to which the Offering was completed, the Company granted the Galen Investor Group an option to invest an additional $5 million in the Company at any time within 18 months from the date of the closing of the Offering in exchange for Debentures and Warrants having terms identical to those issued in the Offering (the "Galen Option"). In June 1998, the Galen Investor Group exercised this option.

The net proceeds of the Offering have, in large part, been used to satisfy a substantial portion of the Company's liabilities and accounts payable. Additionally, pursuant to agreements reached with other large creditors in anticipation of the completion of the Offering, including the Company's landlord and the DOJ, the Company has been able to bring these creditors current and will be in compliance with installment payment agreements providing favorable terms to the Company. The net proceeds from the exercise of the Galen Option have been used, in large part, to fund working capital, including the purchase of raw materials, payroll expenses and other Company expenses.

In addition to the net proceeds from the Offering and the exercise of the Galen Option, the Company secured bridge financing from Galen and certain investors in the Offering in the aggregate amount of $9,504,111 funded through seven separate bridge loan transactions between the period from August through and including December, 1998, as well as an additional bridge loan in March, 1999 (collectively, the "Bridge Loans"). The Bridge Loans were consolidated on December 2, 1998 pursuant to an Amended, Restated and Consolidated Bridge Loan Agreement (the "Consolidated Bridge Loan"). The Consolidated Bridge Loan bears interest at 10% per annum, is secured by a first lien on all of the Company's assets and has a maturity date of May 30, 1999. Approximately $9,120,000 in the principal amount of the Consolidated Bridge Loan was advanced by Galen with the balance of approximately $384,000 advanced by certain investors in the Offering. The Consolidated Bridge Loan was secured by the Company in order to provide necessary working capital. See "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" for a more detailed discussion of the Consolidated Bridge Loan transaction.

Lease of Congers, New York Facility

Effective March 22, 1999, the Company leased, as sole tenant, a pharmaceutical manufacturing facility located in Congers, New York (the "Congers Facility") from Par Pharmaceuticals, Inc. ("Par") pursuant to an Agreement to Lease (the "Lease"). The Congers Facility contains office, warehouse and manufacturing space and is approximately 35,000 square feet. The Lease provides for a term of three years, with a two year renewal option and provides for annual fixed rent of $500,000 per year during the primary term of the Lease and $600,000 per year during the option period. The Lease also covers certain manufacturing and related equipment previously used by Par in its operations at the Congers Facility (the "Leased Equipment"). In connection with the execution of the Lease, the Company and Par entered into a certain Option Agreement pursuant to which the Company may purchase the Congers Facility and the Lease Equipment at any time during the lease term for $5 million.

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As part of the execution of the Lease, the Company and Par entered into a certain Manufacturing and Supply Agreement (the "M&S Agreement") having a minimum term of twenty seven months. The M&S Agreement provides for the Company's contract manufacture of certain designated products manufactured by Par at the Congers Facility prior to the effective date of the Lease. The M&S Agreement also provides that Par will purchase a minimum of $1,150,000 in product during the initial 18 months of the Agreement. The M&S Agreement further provides that the Company will not manufacture, supply, develop or distribute the designated products to be supplied by the Company to Par under the M&S Agreement to or for any other person for a period of three years.

Cessation of California Operations

On March 20, 1998, the Company discontinued the operations of H.R. Cenci Laboratories, a wholly-owned subsidiary. H.R. Cenci Laboratories had been a manufacturer of drug products in liquid preparations. Continuing operating losses and the Company's inability to leverage the manufacturing capacity of Cenci Laboratories were among factors considered by the Board and Management in its determination to cease such operations.

On March 30, 1998, the Company completed the sale of substantially all of the non-real property assets of Cenci Powder Products, a wholly-owned subsidiary, to Zuellig Botanical. The purchase price for the assets consisted of the forgiveness by Zuellig Botanical of approximately $262,000 in indebtedness owed by Cenci Powder to Zuellig Botanical related to the purchase of raw materials. The Agreement provided further that Zuellig Botanical would satisfy the manufacture and delivery requirements of Cenci Powder at its located facility in Fresno, California, under an existing third party supply contract. On December 4, 1998, the Company disposed of the real property owned by Cenci Powder in Fresno, California to an unrelated third party for a net sales price of approximately $73,000. Continuing operating losses and the Company's inability to leverage the manufacturing capacity of Cenci Powder were among the factors considered by the Board and Management in its determination to terminate the operations of Cenci Powder.

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PRODUCTS AND PRODUCT DEVELOPMENT

Generic Drug Products

The Company historically has manufactured and sold a broad range of prescription and over-the-counter drug products. The Company's pharmaceutical product list currently includes a total of approximately 28 products, consisting of 18 dosage forms and strengths of prescription drugs and 10 dosage forms and strengths of over-the-counter drugs. Each dosage form and strength of a particular drug is considered in the industry to be a separate drug product. The Company's drug products are sold in various forms, including liquid and powder preparations, compressed tablets and two-piece, hard-shelled capsules.

Most of the generic drug products manufactured by the Company can be classified within one of the following categories:

1. Antibiotics,

2. Narcotic analgesics,

3. Anti-infective and anti-tubercular drugs,

4. Antihistamines and antihistaminic decongestants, or

5. Antitussives.

During fiscal 1998, sales of antitussives and narcotic analgesics accounted for approximately 75% of total net sales during such year. The Company anticipates that sales of antitussives and narcotic analgesics will continue to represent a significant portion of the Company's revenue.

The Company's development strategy for new drug products has been to focus on the development of a broad-range of generic form drugs, each of which (i) has developed a solid market acceptance with a wide base of customers, (ii) can be sold on a profitable basis notwithstanding intense competition from other drug manufacturers, and (iii) is no longer under patent protection. The Company has also diversified its current product line to include some less widely prescribed drugs as to which limited competition might be expected. In addition, the Company will continue to pursue the development of its existing pharmaceutical business as well as the development of the chemical products business of its Houba subsidiary.

Development activities for each new generic drug product begin several years in advance of the patent expiration date of the brand-name drug equivalent. This is because the profitability of a new generic drug usually depends on the ability of the Company to obtain FDA approval to market that drug product upon or immediately after the patent expiration date of the equivalent brand-name drug. Being among the first to market a new generic drug product is vital to the profitability of the product. As other off-patent drug manufacturers receive FDA approvals on competing generic products, prices and revenues typically decline. Accordingly, the Company's ability to attain profitable operations will, in large part, depend on its ability to develop and introduce new products, the timing of receipt of FDA approval of such products and the number and timing of FDA approvals for competing products.

Active Pharmaceutical Ingredients

In the last few years, the Company has increased its efforts to develop and manufacture active pharmaceutical ingredients also known as bulk chemical products. The development and sale of active pharmaceutical ingredients generally is not subject to the same level of regulation as is the development and sale of drug products; accordingly, active pharmaceutical ingredients may be brought to market substantially sooner than drug products. While the Company currently is focusing on the development and manufacture of active pharmaceutical ingredients for use in production of finished dosage products at the Company's Brooklyn and Congers, New York facilities, active pharmaceutical ingredients eventually may be marketed and sold to third parties.

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RESEARCH AND DEVELOPMENT

The Company conducts research and development activities at each of its Brooklyn and Indiana facilities. The Company's research and development activities consist primarily of new generic drug product development efforts and manufacturing process improvements, as well as the development for sale of new chemical products. New drug product development activities are primarily directed at conducting research studies to develop generic drug formulations, reviewing and testing such formulations for therapeutic equivalence to brand name products and additional testing in areas such as bioavailability, bioequivalence and shelf-life. For fiscal years 1998, 1997 and 1996, total research and development expenditures were $651,000, $979,000 and $1,854,000, respectively. During 1999, the Company's research and development efforts will cover products in a variety of therapeutic applications.

As of March 15, 1999, the Company maintained a full-time staff of five in its Research and Development Departments.

MARKETING AND CUSTOMERS

The application of the AIP to the Company's operations until December 1996, combined with the Company's continuing operating losses and lack of adequate working capital during fiscal 1997 and the first quarter of 1998 resulted in the Company's inability to maintain sufficient raw materials and finish goods inventories to permit the Company to actively solicit customer orders, and when orders were received, to fill such orders promptly. Following the completion of the Offering, new Management adopted a marketing strategy focused on developing and maintaining sufficient raw materials and finish goods inventories so as to permit a targeted sales effort by the Company to a core customer group, with an emphasis on quality, prompt product delivery and excellent customer service. The Company's products are sold by Stephanie Heitmeyer, Vice President of Sales, and three salaried sales persons. Sales of the Company's drugs in dosage form are made primarily to drug wholesalers, drugstore chains, distributors and other manufacturers and are not concentrated in any specific region.

During 1998, the Company had net sales to one customer aggregating 11.5% of total sales. The sales to such customer were made pursuant to a certain contract manufacturing agreement entered into with the Company as part of the Company's sale of its ANDA for oxycodone HCI/325 mg acetaminophen tablets in March, 1995. The Company anticipates that net sales to this customer (which aggregated approximately 22.3% of total sales in 1997) will continue to decline during 1999 and thereafter. The Company does not believe that the continuing decline of net sales to this customer will have a material adverse effect on the Company.

Also during 1998, the Company had net sales to two customers aggregating approximately 19.1% of total sales. The Company believes that the loss of these customers would have a material adverse effect on the Company. During 1997 the Company had net sales to one customer in excess of 10% of total sales, aggregating 22.3% of total sales. During 1996, the Company had net sales to one customer in excess of 10% of total sales, aggregating 10% of total sales.

The estimated dollar amount of the backlog of orders for future delivery as of March 15, 1999 was approximately $500,000 as compared with approximately $800,000 as of March 15, 1998. Although these orders are subject to cancellation, management expects to fill substantially all orders by the second quarter of 1999. The decline in the Company's backlog as of March 15, 1999 compared to that in 1998 is largely a function of the Company's increased efficiency in the processing and filling of customer orders.

GOVERNMENT REGULATION

General

All pharmaceutical manufacturers, including the Company, are subject to extensive regulation by the Federal government, principally by the FDA, and, to a lesser extent, by state and local governments. Additionally, the Company is subject to extensive regulation by the DEA as a manufacturer of controlled substances. The Company cannot predict the extent to which it may be affected by legislative and other

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regulatory developments concerning its products and the healthcare industry generally. The Federal Food, Drug, and Cosmetic Act, the Generic Drug Enforcement Act of 1992, the Controlled Substance Act and other Federal statutes and regulations govern or influence the testing, manufacture, safe labeling, storage, record keeping, approval, pricing, advertising, promotion, sale and distribution of pharmaceutical products. Noncompliance with applicable requirements can result in fines, recall or seizure of products, criminal proceedings, total or partial suspension of production, and refusal of the government to enter into supply contracts or to approve new drug applications. The FDA also has the authority to revoke approvals of new drug applications. The ANDA drug development and approval process now averages approximately eight months to two years. The approval procedures are generally costly and time consuming.

FDA approval is required before any "new drug," whether prescription or over-the-counter, can be marketed. A "new drug" is one not generally recognized by qualified experts as safe and effective for its intended use. Such general recognition must be based on published adequate and well controlled clinical investigations. No "new drug" may be introduced into commerce without FDA approval. A drug which is the "generic" equivalent of a previously approved prescription drug also will require FDA approval. Furthermore, each dosage form of a specific generic drug product requires separate approval by the FDA. In general, as discussed below, less costly and time consuming approval procedures may be used for generic equivalents as compared to the innovative products. Among the requirements for drug approval is that the prospective manufacturer's methods must conform to the CGMPs. CGMPs apply to the manufacture, receiving, holding and shipping of all drugs, whether or not approved by the FDA. CGMPs must be followed at all times during which the drug is manufactured. To ensure full compliance with standards, some of which are set forth in regulations, the Company must continue to expend time, money and effort in the areas of production and quality control. Failure to so comply risks delays in approval of drugs, disqualification from eligibility to sell to the government, and possible FDA enforcement actions, such as an injunction against shipment of the Company's products, the seizure of noncomplying drug products, and/or, in serious cases, criminal prosecution. The Company's manufacturing facilities are subject to periodic inspection by the FDA.

In addition to the regulatory approval process, the Company is subject to regulation under Federal, state and local laws, including requirements regarding occupational safety, laboratory practices, environmental protection and hazardous substance control, and may be subject to other present and future local, state, Federal and foreign regulations, including possible future regulations of the pharmaceutical industry.

Drug Approvals

There are currently three ways to obtain FDA approval of a new drug.

1. New Drug Applications ("NDA"). Unless one of the procedures discussed in paragraph 2 or 3 below is available, a prospective manufacturer must conduct and submit to the FDA complete clinical studies to prove a drug's safety and efficacy, in addition to the bioavailability and/or bioequivalence studies discussed below, and must also submit to the FDA information about manufacturing practices, the chemical make-up of the drug and labeling.

2. Abbreviated New Drug Applications ("ANDA"). The Drug Price Competition and Patent Term Restoration Act of 1984 (the "1984 Act") established the ANDA procedure for obtaining FDA approval for those drugs that are off-patent or whose exclusivity has expired and that are bioequivalent to brand-name drugs. An ANDA is similar to an NDA, except that the FDA waives the requirement of conducting complete clinical studies of safety and efficacy, although it may require expanded clinical bioavailability and/or bioequivalence studies. "Bioavailability" means the rate of absorption and levels of concentration of a drug in the blood stream needed to produce a therapeutic effect. "Bioequivalence" means equivalence in bioavailability between two drug products. In general, an ANDA will be approved only upon a showing that the generic drug covered by the ANDA is bioequivalent to the previously approved version of the drug, i.e., that the rate of absorption and the levels of concentration of a generic drug in the body are substantially equivalent to those of a previously approved equivalent drug. The principle advantage of this approval mechanism is that an ANDA applicant is not required to conduct the same preclinical and clinical studies to demonstrate that the product is safe and effective for its intended use.

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The 1984 Act, in addition to establishing the ANDA procedure, created new statutory protections for approved brand-name drugs. In general, under the 1984 Act, approval of an ANDA for a generic drug may not be made effective until all product and use patents listed with the FDA for the equivalent brand name drug have expired or have been determined to be invalid or unenforceable. The only exceptions are situations in which the ANDA applicant successfully challenges the validity or absence of infringement of the patent and either the patent holder does not file suit or litigation extends more than 30 months after notice of the challenge was received by the patent holder. Prior to enactment of the 1984 Act, the FDA gave no consideration to the patent status of a previously approved drug. Additionally, under the 1984 Act, if specific criteria are met, the term of a product or use patent covering a drug may be extended up to five years to compensate the patent holder for the reduction of the effective market life of that patent due to federal regulatory review. With respect to certain drugs not covered by patents, the 1984 Act sets specified time periods of two to ten years during which approvals of ANDAs for generic drugs cannot become effective or, under certain circumstances, ANDAs cannot be filed if the equivalent brand-name drug was approved after December 31, 1981.

3. "Paper" NDA. An alternative NDA procedure is provided by the 1984 Act whereby the applicant may rely on published literature and more limited testing requirements. While that alternative sometimes provides advantages over the ANDA procedure, it is not frequently used.

Generic Drug Enforcement Act

As a result of hearings and investigations concerning the activities of the generic drug industry and the FDA's generic drug approval process, Congress enacted the Generic Drug Enforcement Act of 1992 (the "Generic Drug Act"). The Generic Drug Act confers significant new authority upon the FDA to impose debarment and civil penalties for individuals and companies who commit certain illegal acts relating to the generic drug approval process.

The Generic Drug Act requires the mandatory debarment of companies or individuals convicted of a federal felony for conduct relating to the development or approval of any ANDA, and gives the FDA discretion to debar corporations or individuals for similar conduct resulting in a federal misdemeanor or state felony conviction. The FDA may not accept or review during the period of debarment (one to ten years in the case of mandatory, or up to five years in the case of permissive, debarment of a corporation) any ANDA submitted by or with the assistance of the debarred corporation or individual. The Generic Drug Act also provides for temporary denial of approval of generic drug applications during the investigation of crimes that could lead to debarment. In addition, in more limited circumstances, the Generic Drug Act provides for suspension of the marketing of drugs under approved generic drug applications sponsored by affected companies. The Generic Drug Act also provides for fines and confers authority on the FDA to withdraw, under certain circumstances, approval of a previously granted ANDA if the FDA finds that the ANDA was obtained through false or misleading statements. The Company was not debarred as a result of the FDA investigation and settlement and the Consent Decree with the FDA makes no provision therefor.

Healthcare Reform

Several legislative proposals to address the rising costs of healthcare have been introduced in Congress and several state legislatures. Many of such proposals include various insurance market reforms, the requirement that businesses provide health insurance coverage for all their employees, significant reductions in the growth of future Medicare and Medicaid expenditures, and stringent government cost controls that would directly control insurance premiums and indirectly affect the fees of hospitals, physicians and other healthcare providers. Such proposals could adversely affect the Company's business by, among other things, reducing the demand, and the prices paid, for pharmaceutical products such as those produced and marketed by the Company. Additionally, other developments, such as (i) the adoption of a nationalized health insurance system or a single payor system, (ii) changes in needs-based medical assistance programs, or (iii) greater prevalence of capitated reimbursement of healthcare providers, could adversely affect the demand for the Company's products.

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COMPETITION

The Company competes in varying degrees with numerous companies in the health care industry, including other manufacturers of generic drugs (among which are divisions of several major pharmaceutical companies) and manufacturers of brand-name drugs. Many of the Company's competitors have substantially greater financial and other resources and are able to expend more money and effort than the Company in areas such as marketing and product development. Although a company with greater resources will not necessarily receive FDA approval for a particular generic drug before its smaller competitors, relatively large research and development expenditures enable a company to support many FDA applications simultaneously, thereby improving the likelihood of being among the first to obtain approval of at least some generic drugs.

One of the principal competitive factors in the generic pharmaceutical market is the ability to introduce generic versions of brand-name drugs promptly after a patent expires. The Company believes that it was at a competitive disadvantage until its release from the AIP program and the FDA's resumption of review of ANDAs submitted by the Company's Brooklyn plant. See "Government Regulation -- Generic Drug Enforcement Act" above. Other competitive factors in the generic pharmaceutical market are price, quality and customer service (including maintenance of sufficient inventories for timely deliveries).

RAW MATERIALS

The raw materials essential to the Company's business are bulk pharmaceutical chemicals purchased from numerous sources. Raw materials are generally available from several sources. The Federal drug application process requires specification of raw material suppliers. If raw materials from a supplier specified in a drug application were to become unavailable on commercially acceptable terms, FDA supplemental approval of a new supplier would be required. During 1998, the Company purchased approximately $2,583,000 of its raw materials (constituting 29% of its aggregate purchases of raw materials) from Mallinckrodt. Although the Company is now able to submit Supplements to the FDA in order to allow the Company to purchase raw materials from alternate sources, there can be no assurance that if the Company were unable to continue to purchase raw materials from this supplier, that the Company would be successful in receiving FDA approval to such Supplement or that it would not face difficulties in obtaining raw materials on commercially acceptable terms. Failure to receive FDA approval for, and to locate, an acceptable alternative source of raw materials would have a material adverse effect on the Company.

The United States Drug Enforcement Administration (the "DEA") limits the quantity of the Company's inventories of certain raw materials used in the production of controlled substances based on historical sales data. In view of the Company's recently depressed sales volume, these DEA limitations could increase the likelihood of raw material shortages and of manufacturing delays in the event the Company experiences increased sales volume or is required to find new suppliers of these raw materials.

SUBSIDIARIES

The Company's Indiana manufacturing operations are conducted by Houba, Inc., an Indiana corporation and wholly-owned subsidiary of the Company. Halsey Pharmaceuticals, Inc., a Delaware corporation, is a wholly-owned subsidiary which is currently inactive. The Company also has the following additional subsidiaries, each of which is currently inactive and anticipated to be dissolved during the remainder of the 1999 fiscal year: Indiana Fine Chemicals Corporation, a Delaware corporation, H.R. Cenci Laboratories, Inc., a California corporation, Cenci Powder Products, Inc., a Delaware corporation, Blue Cross Products, Inc., a New York corporation, and The Medi-Gum Corporation, a Delaware corporation.

EMPLOYEES

As of March 15, 1999, the Company had approximately 160 full-time employees. Approximately 39 employees are administrative and professional personnel and the balance are in production and shipping. Among the professional personnel, 5 are engaged in research and product development. Approximately 45 employees at the Company's Brooklyn plant are represented by a local collective bargaining unit. The collective bargaining agreement between the Company and the union was extended on March 5, 1998

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(retroactive to July 2, 1997) and expires June 30, 2000. Management believes that its relations with its employees and the union are satisfactory.

ITEM 2. PROPERTIES.

Halsey leases, as sole tenant, a pharmaceutical manufacturing facility of approximately 35,000 square feet located at 77 Brenner Drive, Congers, New York. The Agreement of Lease, with an unaffiliated third party, contains a three year term with a two year renewal option and provides for annual fixed rent of $500,000 per year during the primary term of the Lease and $600,000 per year during the renewal period. The primary term of the Lease expires on March 21, 2002. The Leased facility houses a portion of the Company's manufacturing operations and includes office and warehouse space. The Lease also contains an option pursuant to which the Company may purchase the leased premises and improvements (including certain production and related equipment) for a purchase price of $5 million, exercisable at any time during the Lease term.

Halsey leases, as sole tenant, a total of approximately 112,300 square feet in three buildings on Pacific Street and Dean Street in Brooklyn, New York. Each of these leases is between Halsey and unaffiliated lessors. The approximate aggregate minimum rental commitments under these operating leases are as follows: $1,023,000 for the year 1999, $1,075,000 for the year 2000 and $1,128,000 for the year 2001. These leases expire on December 31, 2005. The buildings leased by Halsey in Brooklyn house its research and development operations and a portion of its manufacturing operations.

Halsey leases approximately 4,700 square feet of office space located at 695 North Perryville Road, Building No. 2, Rockford, Illinois. The lease is between the Company and an unaffiliated lessor. The lease has a term of two years expiring March 30, 2000 and calls for annual rental, including maintenance and common area expense, of approximately $50,000 per year. This leased facility houses the Company's principal executive offices, including its sales, administration and finance operations.

Houba owns approximately 45,000 square feet of building space on approximately 30 acres of land in Culver, Indiana, which includes a 15,000 square foot manufacturing facility. This manufacturing facility houses separate plants for the production of Doxycycline raw materials, Doxycycline capsules and tablets. In 1996, in conjunction with a settlement with two former employees, the Company acquired real property, improved by a residential property, in Culver, Indiana adjacent to the manufacturing facility.

ITEM 3. LEGAL PROCEEDINGS.

GOVERNMENTAL PROCEEDINGS

By letter dated October 23, 1995, the Company was notified by the New York State Education Department (the "Department") that the Professional Conduct Officer of the Office of Professional Discipline had determined that there was sufficient evidence of professional misconduct on the Company's part to warrant a disciplinary proceeding under New York law. Upon contacting the Deputy Director of the Office of Professional Discipline, counsel for the Company was advised that the alleged misconduct related to the same activities that were the subject of the DOJ investigation. The Company submitted a written response to the Department on November 16, 1995. The Company and the Department entered into a consent order effective July 18, 1997, concluding any disciplinary proceedings. The consent order requires that the Company pay $175,000 in fines over a period of five years. The consent order also provides that the Company's registration as a manufacturer of drugs in New York State is revoked, but such revocation is stayed and the Company has been placed on probation for a maximum period of five years. The Company has the right to apply for removal from probation two years after the effective date of the consent order. At December 3, 1998, the Company is current in its payment obligations and the remaining balance is $140,000.

Immediately prior to the completion of the Offering, the Company was in default under the consent order with the Department for failure to satisfy two of the monthly installments of the fine as provided in the consent order. Prior to the completion of the Offering, the Company advised the Department as to the existence of the default and that such deficiencies would be corrected upon the completion of the Offering. The Company has

12

satisfied these outstanding amounts and is now current under the consent order with the Department. Based on discussions between representatives of the Department and the Company's outside counsel handling this matter, the Company has been advised that the revocation of the Company's registration as a manufacturer of drugs in the State of New York will remain stayed and that the Company continues to have the right to apply for removal from probation after two years from the effective date of the consent order.

Reference is also made to the discussion of the Company's Plea Agreement and Letter Agreement with the DOJ contained in "Item 1. Business -- Recent Events" and "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations."

OTHER LEGAL PROCEEDINGS

Beginning in 1992, actions were commenced against the Company and numerous other pharmaceutical manufacturers in the Pennsylvania Court of Common Pleas, Philadelphia Division, in connection with the alleged exposure to diethylstilbestrol ("DES"). The defense of all of such matters was assumed by the Company's insurance carrier, and a substantial number have been settled by the carrier. Currently, five actions remain pending with the Company as a defendant, and the insurance carrier is defending each action. Similar actions were brought in Ohio, and have been dismissed based on Ohio law. The Company does not believe any of such actions will have a material impact on the Company's financial condition.

The Company has been named as a defendant in four additional actions, each of which has been referred to the Company's insurance carrier and has been accepted for defense. The first action, Alonzo v. Halsey Drug Co., Inc. and K-Mart Corp., No. 64DOT-95111-CT-2736 (Indiana Superior Court, Porter County), was commenced on November 7, 1995 and involves a claim for unspecified damages relating to the alleged ingestion of "Doxycycline 100." At this early stage of the proceedings, the Company is unable to predict with any degree of certainty the likely outcome of these claims and whether they will have a material adverse effect on the Company's financial condition. The second action, Files v. Halsey Drug Co., Index No. 198787/93 (New York Supreme Court, Suffolk County), commenced on September 16, 1993, seeking $10,000,000 in damages for wrongful death allegedly caused by the ingestion of Isoniazid. Halsey has been dismissed from this action on motion for summary judgment. The third and fourth actions, entitled Hunt v. Halsey Drug Co., Inc., and McCray v. Halsey Drug Co., Inc. (New York State Supreme Court, Kings County), were commenced on October 21, 1993, seeking the recovery of $8,000,000 for alleged personal injuries suffered by two Well Fargo security guards who responded to an alarm and were shot, resulting in the death of one and the injury to the other. The Company is being defended by its insurance carrier. The Company has impleaded the former security service used by the Company as a third-party defendant. These actions were settled at a conference before the Court on December 21, 1998. The settlement documents have been executed, and the settlement is expected to be consummated shortly.

The Company has been named as a defendant in a complaint filed with the United States District Court, Eastern District of New York, on June 30, 1998 (the "Complaint") by Quality Products and Services, L.L.C. The Complaint alleges the existence of a Joint Venture Agreement between the Plaintiff and the Company concerning the development, manufacture and marketing of a single product. The Complaint also alleges that the Company has breached the Agreement by failing to satisfy its respective obligations defined in the Agreement. The Complaint seeks monetary damages of approximately $20 million. The Company believes that the allegations contained in the Complaint are without basis in fact, and that is has meritorious defenses to each of the allegations. The Company has retained counsel and intends to vigorously defend this action. This matter is currently in discovery. The Company has filed a third-party complaint against Rosendo Ferran, the Company's former President, in connection with the Complaint.

The Company has been named as a defendant in an action in Suffolk County, New York, by Designed Laboratories, Inc., for construction work allegedly performed at the Company's facilities in Brooklyn. Plaintiffs is seeking approximately $148,000. The Company has no records of work being performed by this entity, and is therefore defending the action.

The Company's former President, Rosendo Ferran, has instituted an arbitration against the Company, seeking sums allegedly due under his employment contract in the amount of $225,000.00, deferred salary in

13

the approximate amount of $100,000.00, and unspecified damages upon allegations of age, ethnic and religious discrimination. The Company believes it has meritorious defenses to the allegations claimed in the arbitration. The Company does not believe this claim will have a material adverse effect on the Company's financial condition.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

No matters were submitted to a vote of security holders during the fourth quarter of 1998.

PART II

ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED SECURITY HOLDER

MATTERS.

MARKET AND MARKET PRICES OF COMMON STOCK

The Company's Common Stock is listed on the American Stock Exchange (the "Exchange") under the symbol "HDG." Set forth below for the periods indicated are the high and low sales prices for the Common Stock as reported on the Exchange.

PERIOD                                                        HIGH        LOW
------                                                        ----        ---
1999 Fiscal Year
  First Quarter (through March 15, 1999)....................   1 9/16      1
1998 Fiscal Year
  First Quarter.............................................   3 5/8       1 1/4
  Second Quarter............................................   3 1/8       2 3/8
  Third Quarter.............................................   2 3/4       1 1/2
  Fourth Quarter............................................   1 7/8       1
1997 Fiscal Year
  First Quarter.............................................   6           4 3/8
  Second Quarter............................................   5 1/8       2 9/16
  Third Quarter.............................................   4 13/16     2 5/16
  Fourth quarter............................................   4 13/16     1 5/16

The Company does not meet certain of the Exchange's criteria for continued listing. Accordingly, there can be no assurance that the Company's common stock will remain listed on the American Stock Exchange or that the Exchange will not commence a review of the Company's continued listing eligibility. If the Common Stock should become delisted from the Exchange, trading, if any, in the Common Stock would continue on the OTC Bulletin Board, an NASD-sponsored inter-dealer quotation system, or in what is commonly referred to as the "Pink Sheets". In such event, a shareholder may find it more difficult to dispose of, or to obtain accurate quotations as to the market value of the Common Stock.

HOLDERS

There were 827 holders of record of the Company's common stock on March 15, 1999. This number, however, does not reflect the ultimate number of beneficial holders of the Company's common stock.

DIVIDEND POLICY

The payment of cash dividends from current earnings is subject to the discretion of the Board of Directors and is dependent upon many factors, including the Company's earnings, its capital needs and its general financial condition. The terms of the Company's 5% convertible senior secured debentures and the Consolidated Bridge Loan prohibit the Company from paying cash dividends. The Company does not intend to pay any cash dividends in the foreseeable future.

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PRIVATE OFFERINGS

The Company secured bridge financing from Galen and certain investors in the Offering in the aggregate amount of $9,504,111, funded through seven separate bridge loan transactions between the period August through and including December, 1998, as well as an additional bridge loan completed in March, 1999 (collectively, the "Bridge Loans"). The Bridge Loans were consolidated on December 2, 1998 pursuant to an Amended, Restated and Consolidated Bridge Loan Agreement, as amended to permit the March, 1999 bridge loan (the "Consolidated Bridge Loan"). The Consolidated Bridge Loan is evidenced by ten (10%) percent convertible senior secured promissory notes which are convertible at any time prior to the maturity date of May 30, 1999 into shares of the Company's Common Stock at a conversion price of approximately $1.368 per share with respect to approximately $7,820,000 of such indebtedness, $1.331 per share with respect to approximately $284,000 of such indebtedness, and $1.197 per share with respect to approximately $1,400,000 of such indebtedness, for an aggregate of 7,099,338 shares of Common Stock (such conversion prices equal the fair market value of the Common Stock at the date of issuance of the convertible promissory notes). In addition, in consideration for the initial extension for the Bridge Loans and the extension of the maturity dates of the Bridge Loans pursuant to the consolidation of such loans on December 2, 1998, the Company issued common stock purchase warrants to the lenders in the Consolidated Bridge Loan to purchase an aggregate of approximately 1,009,909 shares of the Company's Common Stock. The Bridge Loan warrants are substantially identical to those issues in the debenture and warrant offering completed March 10, 1998.

Each of the lenders in the Consolidated Bridge Loan transaction are accredited investors as defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended (the "Act"). The convertible notes and warrants issued in connection with the Consolidated Bridge Loan were issued without registration under the Act in reliance upon Section 4(2) of the Act and Regulation D promulgated thereunder.

ITEM 6. SELECTED FINANCIAL DATA.

The selected consolidated financial data presented on the following pages for the years ended December 31, 1998, 1997, 1996, 1995 and 1994 are derived from the Company's audited Consolidated Financial Statements. The Consolidated Financial Statements as of December 31, 1998 and December 31, 1997, and for each of the years in the three year period ended December 31, 1998, and the report thereon, are included elsewhere herein. The selected financial information as of and for the years ended December 31, 1995 and 1994 are derived from the audited Consolidated Financial Statements of the Company not presented herein.

The information set forth below is qualified by reference to, and should be read in conjunction with, the Consolidated Financial Statements and related notes thereto included elsewhere in this Report and "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations."

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                                                         YEARS ENDED DECEMBER 31,
                                     ----------------------------------------------------------------
                                        1998          1997          1996         1995         1994
                                     -----------   -----------   ----------   ----------   ----------
                                                  (IN THOUSANDS, EXCEPT PER SHARE DATA)
OPERATING DATA:
Net sales..........................  $     8,841   $     9,088   $   12,379   $   20,225   $   24,182
Costs and expenses
  Cost of sales....................       12,712        15,407       16,826       18,097       21,584
Research and development...........          651           979        1,854          818          502
Selling, general and
  administrative...................        8,078         6,308        7,486        6,098        7,128
Interest expense...................        1,946         1,144        1,708        1,307          735
Loss (Gain) on sale of assets......       (1,822)          264       (1,000)      (2,288)          --
Income (loss) before provision for
  income taxes.....................      (12,724)      (15,014)     (14,495)      (3,807)      (5,767)
Provision (benefit) for
  income taxes.....................           --            --           --          296           --
Net income (loss)..................      (12,724)  $   (15,014)  $  (14,495)  $   (4,103)  $   (5,767)
                                     ===========   ===========   ==========   ==========   ==========
Net income (loss) per share........  $      (.92)  $     (1.12)  $    (1.49)  $     (.52)  $     (.80)
                                     ===========   ===========   ==========   ==========   ==========
Weighted average common shares
  outstanding......................   13,812,529    13,434,215    9,724,106    7,886,101    7,173,908
                                     ===========   ===========   ==========   ==========   ==========

                                                            DECEMBER 31,
                                       -------------------------------------------------------
                                         1998        1997        1996        1995       1994
                                       --------    --------    --------    --------    -------
                                                (IN THOUSANDS, EXCEPT PER SHARE DATA)
BALANCE SHEET DATA:
Working capital (deficiency).........  $ (6,665)   $(22,304)   $(12,201)   $ (7,393)   $(4,451)
Total assets.........................    15,913       7,667      11,982      18,862     19,276
Total liabilities....................    44,866      27,524      19,063      20,402     19,924
Retained earnings
  (accumulated deficit)..............   (57,221)    (44,497)    (29,484)    (14,989)   (10,886)
Stockholders' equity (deficit).......   (28,953)    (19,857)     (7,081)     (1,540)      (468)

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Certain statements set forth under this caption constitute "forward-looking statements" within the meaning of the Reform Act. See "Special Note Regarding Forward-Looking Statements " on page 1 of this Report for additional factors relating to such Statements.

OVERVIEW

The Company reported a net loss of $12,724,000 or $.92 per share for the year ended December 31, 1998 as compared with the net loss of $15,015,000 or $1.12 per share for 1997. Sales for the year ended December 31, 1998 were approximately $8,841,000 as compared to sales of approximately $9,088,000 for 1997. Notwithstanding these results, the Company had the following achievements in 1998:

- Received infusion of capital enabling the Company to settle past obligations and provide for future opportunities.

- Reestablished itself in the marketplace as a dependable supplier of quality products, expanded its customer base and reduced reliance upon a single customer.

- Reestablished relationships with suppliers.

- Received approval from the FDA of two ANDA's, submitted five others for approval and continued development on additional products for submission in 1999.

- Discontinued certain non-core operations and reduced the workforce by approximately 25%.

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RESULTS OF OPERATIONS

The following chart reflects expenses, earnings, income, losses and profits expressed as a percentage of net sales for the years 1998, 1997 and 1996.

                                                                            PERCENTAGE CHANGE
                                                                               YEAR-TO-YEAR
                                                                           INCREASE (DECREASE)
                                          PERCENTAGE OF NET SALES              YEARS ENDED
                                            YEAR ENDED DECEMBER                DECEMBER 31,
                                         --------------------------    ----------------------------
                                          1998      1997      1996     1997 TO 1998    1996 TO 1997
                                         ------    ------    ------    ------------    ------------
Net sales..............................     100%      100%    100.0%       (2.7)           (26.6)
Cost of Goods..........................   143.8     169.5     135.9       (17.5)           (8.47)
Gross Profit...........................   (43.8)    (69.5)    (35.9)      (38.7)            42.1
Research & Development.................     7.4      10.8      15.0       (33.5)            47.2
Selling, general and administrative
  expense..............................    91.4      69.4      60.5        29.5            (15.7)
(Loss) from operations.................  (142.5)   (149.7)   (111.4)       (6.7)            (1.3)
Interest expense.......................    22.0      12.6      13.9        70.1            (33.0)
Other (income) expenses................   (20.6)      2.9      (8.2)         --           (126.4)
(Loss) before income taxes.............  (143.9)   (165.2)   (117.1)      (14.6)             3.6
Net (loss).............................  (143.9)%  (165.2)%  (117.1)%     (14.6)%            3.6%
                                                   ======    ======                       ======

NET SALES

Net sales for 1998 of $8,841,000 represents a decrease of $247,000 as compared to net sales for 1997. The decrease is attributable in part to a reduction in toll manufacturing revenue from Mallinckrodt of approximately $878,000 from the prior year. Additionally, the Company was unable to market successfully to the retail pharmacy marketplace until the third quarter of 1998 because during fiscal 1996 and 1997, the Company had failed to pay required rebates to state Medicaid agencies. This caused those states to deny medicaid reimbursement to the retail pharmacies on their sales of the Company's products. Commensurate with the infusion of new capital and personnel in March, 1998, the Company began reestablishing itself in good standing with all states. This task was completed by July, 1998. Also during much of 1988, the Company experienced difficulty in obtaining certain raw materials which reduced sales. These shortages were remedied by December 31, 1998.

Net sales for 1997 of $9,088,000 represents a decreased of $3,291,000 as compared to net sales for 1996. This decrease is primarily attributable to a lack of sufficient working capital necessary to purchase raw materials. Without adequate inventory, the Company was unable to satisfy customer orders in a timely fashion and caused customers to procure products from competitors.

GROSS MARGINS

The Company's gross margin for 1998 of (43.8)% is a 38.7% improvement over gross margin for 1997. This improvement is due, in part, to the elimination of non-core manufacturing operations in California, tighter inventory controls and a general reduction in manufacturing labor. Additionally, the Company's revenues in 1998 from sales to Mallinckrodt under a toll manufacturing agreement decreased by approximately $878,000. The gross margins on these products were substantially less than on the Company's other products.

The Company's gross margin for 1997 of (69.5)% is a 42.1% reduction over gross margin for 1996. This deterioration occurred because the Company failed to react quickly enough to falling sales by decreasing manufacturing expenses. Additionally, the Company incurred approximately $1,572,000 of manufacturing costs in operating non-core facilities that generated sales of only $495,000.

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RESEARCH & DEVELOPMENT EXPENSES

For 1998, research and development expenses amounted to $651,000 as compared to $979,000 for 1997. The decrease primarily reflects the costs of biostudies performed in 1997 that were not duplicated in 1998.

For 1997, research and development expenses amounted to $979,000 as compared to $1,854,000 for 1996. This decrease was a result of reductions in personnel necessitated by the Company's liquidity crisis.

The Company expects research and development expenses to increase significantly in 1999 consistent with its plans to increase the number of ANDA submissions as compared to 1998.

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES

Selling, general and administrative costs were $8,078,000 (91.4% of net sales) for 1998 compared to $6,308,000 (69.4% of net sales) for 1997. This increase is primarily due to costs associated with capital financing, legal expenses and settlement costs of certain litigation, severance costs associated with personnel reductions, installation of a new information system and costs associated with expanded regulatory and compliance departments.

Selling, general and administrative costs were $6,308,000 (69.4% of net sales) for 1997 compared to $7,486,000 (60.5% of net sales) for 1996. This decrease is due primarily to a reduction in legal expenses and litigation settlements as compared to 1996.

INTEREST EXPENSE

Interest expense for 1998 increased by 62% over that of 1997 reflecting the substantial new debt in the form of $25,800,000 of convertible debentures that was added in 1998 [include bridge loan debt?]. Interest expense for 1997 decreased 33.0% as compared to 1996 due primarily to the conversion in the latter part of 1996 of $7,740,000 of convertible debentures bearing interest at 10% into common stock. Interest expense for 1996 increased 77.8% as compared to 1995 as a result of a higher level of borrowings due to the issuance of convertible subordinated debentures, as well as fees payable to the Company's banks.

OTHER INCOME

Included in other income for 1998 is $1,900,000 realized from the sale of certain assets to Mallinckrodt. This transaction was entered into in 1997 but the conditions for realization of the gain from the sale were not met until 1998.

PROVISION FOR INCOME TAXES

The Company had no tax (benefit) provision for 1998, 1997 and 1996 since the available loss carry back to prior years was completely utilized by the net operating loss for 1993 carry back to the prior three years. At December 31, 1998, the Company has a Federal tax refund claim of approximately $1,000,000 pending before the tax authorities. In the meantime, the IRS is holding up action to collect approximately $1,300,000 of past due payroll taxes. Additionally, the Company has negotiated payment plans for approximately $500,000 of past due state and local taxes. The Company has net operating loss carryforwards of approximately $45,600,000 which expire in the years 2011 through 2018.

LIQUIDITY AND CAPITAL RESOURCES

At December 31, 1998, the Company had cash and cash equivalents of $1,850,000 as compared to $26,000 at December 31, 1997. The Company had a working capital deficit at December 31, 1998 of $(6,665,000).

On March 10, 1998, the Company completed the Offering to Galen Partners III, L.P., Galen Partners International III, L.P., Galen Employee Fund III, L.P. (collectively, "Galen") and each of the Purchasers (along with Galen, collectively the "Galen Investor Group") listed on the signature page to a certain Debenture and Warrant Purchase Agreement dated March 10, 1998 (the "Purchase Agreement"). The net

18

proceeds to the Company from the Offering, after deduction of related Offering expenses, were approximately $19.6 million. The securities issued in the Offering consisted of 5% convertible senior secured debentures (the "Debentures") and common stock purchase warrants (the "Warrants") exercisable for an aggregate of 4,202,020 shares of the Company's common stock. In addition, in accordance with the terms of the Purchase Agreement, the Company granted the Galen Investor Group an option to invest an additional $5 million in the Company at any time within 18 months from the date of the closing of the Offering in exchange for Debentures and Warrants having terms identical to those issued in the Offering (the "Option"). In June 1998, the Galen Investor Group exercised the Option.

The net proceeds of the Offering were, in large part, used to satisfy a substantial portion of the Company's liabilities and accounts payable. Such liabilities include the full satisfaction of the Company's Bank indebtedness and related fees, payment of arrearages in rent to the landlord of the Brooklyn facility and satisfaction of outstanding judgments and liens. Additionally, pursuant to agreements reached with other large creditors in anticipation of the completion of the Offering, including the Department of Justice, the Company has been able to bring these creditors current and bring the Company into compliance with installment payment agreements providing more favorable terms to the Company. The Offering proceeds also allowed the Company to satisfy its outstanding state and Federal payroll tax obligations and meet current payroll tax obligations. The net proceeds from the exercise of the Option were used to fund working capital, including the purchase of raw materials, payroll expenses and other Company expenses.

Prior to the completion of the Offering, the Company was in negotiations with the DOJ to restructure the payment of the $2,500,000 fine that had been levied under the Plea Agreement in order to address the Company's failure to satisfy the $125,000 quarterly installments provided for under the Plea Agreement. On March 30, 1998, the Company and the DOJ signed a Letter Agreement serving to amend the Plea Agreement relating to the terms of the Company's satisfaction of the fine assessed under the Plea Agreement. Specifically, the Letter Agreement provides that the Company will satisfy the remaining $2,150,000 of the fine through the payment of $25,000 on a monthly basis commencing June 1, 1998, plus interest on such outstanding balance (at the rate calculated pursuant to 28 U.S.C. Section 1961)(currently 5.319%). Such payment schedule would result in the full satisfaction of the DOJ fine in January, 2006. The Letter Agreement also provides certain restrictions on the payment of salary or compensation to any individual in excess of $150,000 without the written consent of the United States District Court for the District of Maryland, subject to certain exceptions. In addition, the Letter Agreement requires the prepayment of the outstanding fine to the extent of 25% of the Company's after tax profit and 25% of the net proceeds received by the Company on any sale of a capital asset for a sum in excess of $10,000.

During the period from May 1997 through July 1997, the Company borrowed approximately $3 million from Mylan Laboratories, Inc. pursuant to five unsecured, demand promissory notes. The advances made by Mylan Laboratories, Inc. were part of a proposed investment by Mylan Laboratories, Inc. in the Company, including the proposed purchase of the Company's Houba Indiana facility as well as a partial tender offer for the Company's common stock. The Company used the proceeds of these borrowings for working capital. To date, $236,000 has been paid by the Company to Mylan against such indebtedness in the form of product deliveries to Mylan. Pursuant to an agreement reached between the parties, the Company is required to satisfy interest on the outstanding indebtedness on an annual basis while the indebtedness remains outstanding and to satisfy the principal amount of such indebtedness in the form of product deliveries to Mylan until such time as the indebtedness is satisfied in full.

The Company secured bridge financing from Galen and certain investors in the Offering in the aggregate amount of $9,504,111, funded through seven separate bridge loan transactions between the period from August through and including December, 1998, as well as an additional bridge loan in March, 1999 (collectively, the "Bridge Loans"). The Bridge Loans were consolidated on December 2, 1998 pursuant to an Amended, Restated and Consolidated Bridge Loan Agreement, as amended to permit the March, 1999 bridge loan (the "Consolidated Bridge Loan"). The Consolidated Bridge Loan bears interest at 10% per annum, is secured by a first lien on all of the Company's assets and has a maturity date of May 30, 1999. Approximately $9,120,000 in the principal amount of the Consolidated Bridge Loan was advanced by Galen with the balance of approximately $384,000 advanced by certain investors in the Offering. The Consolidated Bridge Loan is

19

evidenced by 10% convertible senior secured promissory notes which are convertible at any time prior to maturity into shares of the Company's Common Stock at a conversion price of approximately $1.368 per share with respect to approximately $7,820,000 of such indebtedness, $1.331 per share with respect to approximately $284,000 of such indebtedness, and $1.197 per share with respect to approximately $1,400,000 of such indebtedness, for an aggregate of 7,099,338 shares of common stock (such conversion prices equal the fair market value of the Common Stock at the date of issuance of the convertible promissory notes). In addition, in consideration for the initial extension of the Bridge Loans and the extension of the maturity dates of the Bridge Loans pursuant to the consolidation of such loans on December 2, 1998, as amended to permit the March, 1999 bridge loan, the Company issued common stock purchase warrants to Galen and the other investors in the Consolidated Bridge Loan, to purchase an aggregate of approximately 1,009,909 shares of the Company's common stock (representing warrants to purchase 50,000 shares of Common Stock for each $1,000,000 in principal amount of Bridge Loan having a term of 90 days from the date of the making of the Bridge Loan). The Bridge Loan warrants are substantially identical to those issued by the Company in its Debenture and Warrant Offering completed on March 10, 1998.

The Consolidated Bridge Loan was obtained by the Company in order to provide necessary working capital. In view of the Company's current cash reserves and projections for revenues through May 30, 1999, the Company will be unable to satisfy the Consolidated Bridge Loan in full at the stated maturity date of May 30, 1999. Galen, the holder of approximately 96% of such indebtedness, has indicated to the Company a willingness to cooperate in the restructuring of the indebtedness evidenced by the Consolidated Bridge Loan to extend the maturity date of such debt and/or convert the debt into common stock or longer-term convertible indebtedness. The terms of such restructuring will depend, to a large extent, on the terms and timing of any third-party investment, as described below. Accordingly, the terms of any such restructuring have yet to be agreed to by the parties and will be subject to the negotiation and preparation of definitive agreements.

The Company is in preliminary discussions with an unaffiliated third party concerning the terms of a proposed investment in the Company in an amount of up to $15 million, to be funded in three equal increments based on the achievement of certain milestones. The structure of the investment will likely take the form of convertible debentures and common stock purchase warrants, similar in many respects to the debentures and warrants issued by the Company in its March 10, 1998 offering. The discussions with this third party investor are in the preliminary stages and no assurance can be given that final terms acceptable to the Company will result and/or that if consummated, that the Company will be successful in achieving the milestones necessary to fund all or any portion of the proposed investment.

In the event the Company is successful in restructuring the Consolidated Bridge Loan and completing a third party investment of the type and size described above, the Company will have sufficient cash reserves to satisfy its working capital requirements for at least the next 12 months. The Company is also seeking to secure a senior revolving line of credit from a banking institution. There can be no assurance, however, that the Company will be able to obtain such third party investment or a bank facility. If the Company is unable to complete the third party investment described above or obtain other sources of working capital, including a bank line of credit or proceeds from the issuance of debt and/or equity securities, the Company's cash reserves will be sufficient to satisfy the Company's working capital requirements for approximately two to three months. Failure to obtain a third party investment of the type described above, a bank line of credit or alternative sources of financing of a comparable amount in the near term will materially adversely affect the Company's working capital position and financial condition and results of operations.

CAPITAL EXPENDITURES

The Company's capital expenditures during 1998, 1997 and 1996 were $1,545,000, $85,000 and $390,000. The increase in capital expenditures in 1998 as compared to prior years is attributable to the implementation of certain equipment and facility upgrades that had been delayed in prior years due to the Company's cash conservation measures in those years.

20

YEAR 2000 COMPLIANCE

The Company is aware of issues associated with the programming code in existing computer systems as the Year 2000 approaches and has undertaken a compliance program to assess the Company's potential exposure to business interruptions due to the possible Year 2000 computer software failures, including necessary remediation and testing. In 1999, the Company installed a new information system, including hardware and software, which the Company believes, based on its testing, is Year 2000 compliant.

At this time, the Company is not aware of any material Year 2000 issues with respect to dealings with third parties, however, the assessment phase of such risks of third parties is in the early stage of review.

In the event the Year 2000 issues were to disrupt the Company and its operations, such disruption may have a material impact on the Company and its results of operations. Given that no significant issues have arisen based on the assessments to date, the Company has identified a preliminary contingency plan and is prepared to make necessary corrections to its systems in the event a problem should occur. The Company will continue to assess the Year 2000 compliance issue on an on-going basis in an effort to resolve any Year 2000 issues in a timely manner.

IMPACT OF INFLATION

The Company believes that inflation did not have a material impact on its operations for the periods reported. Significant increases in labor, employee benefits and other expenses could have a material adverse effect on the Company's performance.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

The response to this item is submitted as a separate section of this Report commencing on page F-1.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

Not Applicable.

PART III

In accordance with General Instruction G(3) of Form 10-K, the information called by Item 10, Directors and Executive Officers of the Registrant, Item 11, Executive Compensation, Item 12, Security Ownership of Certain Beneficial Owners and Management, and Item 13, Certain Relationships and Related Transactions, of Part III of this Report is incorporated by reference to the Company's definitive Proxy Statement for its 1999 Annual Meeting of Shareholders.

PART IV

ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K.

(a) Financial Statements -- See Index to Financial Statements.

(b) Reports on Form 8-K

No reports on Form 8 K were filed during the last quarter of the fiscal year covered by this Annual Report on Form 10-K.

(c) Exhibits

The following exhibits are included as a part of this Annual Report on Form 10-K or incorporated herein by reference.

21

EXHIBIT
 NUMBER                               DOCUMENT
-------                               --------
 *3.1       Certificate of Incorporation and amendments.
  3.2       Restated Bylaws (incorporated by reference to Exhibit 3.1 to
            the Registrant's Quarterly Report on Form 10-Q for the
            quarter ended June 30, 1993).
 *3.3       Restated By-Laws
 10.1       Credit Agreement, dated as of December 22, 1992, among the
            Registrant and The Chase Manhattan Bank, N.A. (incorporated
            by reference to Exhibit 10.1 to the Registrant's Annual
            Report on Form 10-K for the year ended December 31, 1992
            (the "1992 Form 10-K")).
 10.2       Amendment Two, dated as of January 12, 1994, to Credit
            Agreement among the Registrant and The Chase Manhattan Bank,
            N.A., together with forms of Stock Warrant and Registration
            Rights Agreement (incorporated by reference to Exhibit 10.1.
            to the Registrant's Annual Report on Form 10-K for the year
            ended December 31, 1993 (the "1993 Form 10-K")).
 10.3       Amendment Three, dated as of May 31, 1994, to Credit
            Agreement among the Registrant and The Chase Manhattan Bank,
            N.A. (incorporated by reference to Exhibit 6(a) to the
            Registrant's Quarterly Report on Form 10-Q for the quarter
            ended March 31, 1994).
 10.4       Amendment Four, dated as of July 1994, to Credit Agreement
            among the Registrant and The Chase Manhattan Bank, N.A.
            (incorporated by reference to Exhibit 6(a) to the
            Registrant's Quarterly Report on Form 10-Q for the quarter
            ended June 30, 1994).
 10.5       Amendment Five, dated as of March 21, 1995, to Credit
            Agreement among the Registrant and The Chase Manhattan Bank,
            N.A. (incorporated by reference to Exhibit 10.7 to the
            Registrant's Current Report on Form 8-K dated March 21, 1995
            (the "March 8-K")).
 10.5(l)    Form of Warrants issued to The Bank of New York, The Chase
            Manhattan Bank, N.A. and the Israel Discount Bank
            (incorporated by reference to Exhibit 10.5(i) to the
            Registrant's Annual Report on Form 10-K for the year ended
            December 31, 1995 (the "1995 Form 10-K")).
 10.5(2)    Letter Agreement, dated July 10, 1995, among Halsey Drug
            Co., Inc., The Chase Manhattan Bank, N.A., The Bank of New
            York and Israel Discount Bank of New York (incorporated by
            reference to Exhibit 6(a) to the Registrant's Quarterly
            Report on Form 10-Q for the quarter ended June 30, 1995 (the
            "June 10-Q")).
 10.5(3)    Letter Agreement, dated November 16, 1995, among Halsey Drug
            Co., Inc., The Chase Manhattan Bank, N.A., The Bank of New
            York and Israel Discount Bank of New York (incorporated by
            reference to Exhibit 10.25(iv) to the 1995 10-K).
 10.5(4)    Amendment 6, dated as of August 6, 1996, to Credit Agreement
            among Halsey Drug Co., Inc., The Chase Manhattan Bank, N.A.,
            The Bank of New York and Israel Discount Bank of New York
            (incorporated by reference to Exhibit 10.1 to Amendment No.
            1 to the Registrant's Quarterly Report on Form 10-Q for the
            quarter ended June 30, 1996 (the "June 1996 10-Q").
 10.5(5)    Letter Agreement, dated March 25, 1997 among Halsey Drug
            Co., Inc., The Chase Manhattan Bank, as successor in
            interest to The Chase Manhattan Bank (National Association),
            The Bank of New York and Israel Discount Bank.
 10.6       Agreement Regarding Release of Security Interests dated as
            of March 21, 1995 by and among the Company, Mallinckrodt
            Chemical Acquisition, Inc. and The Chase Manhattan Bank,
            N.A. (incorporated by reference to Exhibit 10.9 of the March
            8-K).
 10.7       Consulting Agreement dated as of September, 1993 between the
            Registrant and Joseph F. Limongelli (incorporated by
            reference to Exhibit 10.6 to the 1993 Form 10-K).
 10.8       Employment Agreement, dated as of January 1, 1993, between
            the Registrant and Rosendo Ferran (incorporated by reference
            to Exhibit 10.2 to the 1992 Form 10-K).
 10.10(1)   Halsey Drug Co., Inc. 1984 Stock Option Plan, as amended
            (incorporated by reference to Exhibit 10.3 to the 1992 Form
            10-K).
 10.10(2)   Halsey Drug Co., Inc. 1995 Stock Option and Restricted Stock
            Purchase Plan (incorporated by reference to Exhibit 4.1 to
            the Registrant's Registration Statement on Form S-8, File
            No. 33-98396).
 10.10(3)   Halsey Drug Co., Inc. Non-Employee Director Stock Option
            Plan.

22

EXHIBIT
 NUMBER                               DOCUMENT
-------                               --------
 10.11      Leases, effective February 13, 1989 and January 1, 1990,
            respectively, among the Registrant and Milton J. Ackerman,
            Sue Ackerman, Lee Hinderstein, Thelma Hinderstein and
            Marilyn Weiss (incorporated by reference to Exhibits 10.6
            and 10.7, respectively, to the Registrant's Annual Report on
            Form 10-K for the year ended December 31, 1989).
 10.12      Lease, effective as of April 15, 1988, among the Registrant
            and Milton J. Ackerman, Sue Ackerman, Lee Hinderstein,
            Thelma Hinderstein and Marilyn Weiss, and Rider thereto
            (incorporated by reference to Exhibit 10.12 to the
            Registrant's Annual Report on Form 10-K for the year ended
            December 31, 1987).
 10.12(l)   Lease, as of October 31, 1994, among Registrant and Milton
            J. Ackerman, Sue Ackerman, Lee Hinderstein, Thelma
            Hinderstein and Marilyn Weiss, together with Modification,
            Consolidation and Extension Agreement (incorporated by
            reference to Exhibit 10. 12(i) to the 1995 Form 10-K).
 10.13      Asset Purchase Agreement dated as of March 21, 1995 among
            Mallinckrodt Chemical Acquisition, Inc. ("Acquisition"),
            Mallinckrodt Chemical, Inc., as guarantor and the Registrant
            (incorporated by reference to Exhibit 10.1 to the March
            8-K).
 10.14      Toll Manufacturing Agreement for APAP/Oxycodone Tablets
            dated as of March 21, 1995 between Acquisition and the
            Registrant (incorporated by reference to Exhibit 10.2 to the
            March 8-K).
 10.15      Capsule ANDA Option Agreement dated as of March 21, 1995
            between Acquisition and the Registrant (incorporated by
            reference to Exhibit 10.3 to the March 8-K).
 10.16      Tablet ANDA Noncompetition Agreement dated as of March 21,
            1995 between the Registrant and Acquisition (incorporated by
            reference to Exhibit 10.4 to the March 8-K).
 10.17      Subordinated Non-Negotiable Promissory Term Note in the
            amount of $1,200,00 dated March 21, 1995 issued by the
            Registrant to Acquisition (incorporated by reference to
            Exhibit 10.5 to the March 8-K).
 10.18      Term Note Security Agreement dated as of March 21, 1995
            among the Company, Houba, Inc. and Acquisition (incorporated
            by reference to Exhibit 10.6 to the March 8-K).
 10.19      Amendment dated March 21, 1995 to Subordination Agreement
            dated as of July 21, 1994 between Mallinckrodt Chemical,
            Inc., Mallinckrodt Chemical Acquisition, Inc., the
            Registrant, The Chase Manhattan Bank (National Association),
            Israel Discount Bank of New York, The Bank of New York, and
            The Chase Manhattan Bank (National Association)
            (incorporated by reference to Exhibit 10.8 to the March
            8-K).
 10.20      Agreement dated as of March 30, 1995 between the Registrant
            and Zatpack, Inc. (incorporated by reference to Exhibit
            10.10 to the March 8-K).
 10.21      Waiver and Termination Agreement dated as of March 30, 1995
            between Zuellig Group, W.A., Inc. and Indiana Fine Chemicals
            Corporation (incorporated by reference to Exhibit 10.11 to
            the March 8-K).
 10.22      Convertible Subordinated Note of the Registrant dated
            December 1, 1994 issued to Zatpack, Inc. (incorporated by
            reference to Exhibit 10.12 to the March 8-K).
 10.23      Agreement dated as of March 30, 1995 among the Registrant,
            Indiana Fine Chemicals Corporation, Zuellig Group, N.A.,
            Inc., Houba Inc., Zetapharm, Inc. and Zuellig Botanical,
            Inc. (incorporated by reference to Exhibit 10.13 to the
            March 8-K).
 10.24      Supply Agreement dated as of March 30, 1995 between Houba,
            Inc. and ZetaPharm, Inc. (incorporated by reference to
            Exhibit 10.14 to the March 8-K).
 10.25      Form of 10% Convertible Subordinated Debenture (incorporated
            by reference to Exhibit 6(a) to the June 10-Q).
 10.26      Form of Redeemable Common Stock Purchase Warrant
            (incorporated by reference to Exhibit 6(a) to the June
            10-Q).
 10.27      Form of 10% Convertible Subordinated Debenture (incorporated
            by reference to Exhibit 4.1 to the Registrant's Current
            Report on Form 8-K dated December 4, 1995 (the "December
            8-K")).
 10.28      Form of Redeemable Common Stock Purchase Warrant
            (incorporated by reference to Exhibit 4.2 to the December
            8-K).
 10.29      Form of 10% Convertible Subordinated Debenture (incorporated
            by reference to Exhibit 99 to the June 1996 10-Q).

23

EXHIBIT
 NUMBER                               DOCUMENT
-------                               --------
 10.30      Form of Redeemable Common Stock Purchase Warrant
            (incorporated by reference to Exhibit 4.1 to Amendment No. 1
            to the June 1996 10-Q).
 10.31      Form of 5% Convertible Senior Secured Debenture
            (incorporated by reference to Exhibit 4.1 to the
            Registrant's Current Report on Form 8-K dated March 24, 1998
            (the "March 1998 8-K")).
 10.32      Form of Common Stock Purchase Warrant (incorporated by
            reference to Exhibit 4.2 to the March 1998 8-K).
 10.33      Debenture and Warrant Purchase Agreement dated March 10,
            1998, by and among the Registrant, Galen Partners III, L.P.
            and the other Purchasers listed on the Signature Page
            thereto (incorporated by reference to Exhibit 10.1 to the
            March 1998 8-K).
 10.34      Form of General Security Agreement of Halsey Drug Co., Inc.
            dated March 10, 1998 (incorporated by reference to Exhibit
            10.2 to the March 1998 8-K).
 10.35      Form of Agreement of Guaranty of Subsidiaries of Halsey Drug
            Co., Inc. dated March 10, 1998 (incorporated by reference to
            Exhibit 10.3 to the March 1998 8-K).
 10.36      Form of Guarantor General Security Agreement dated March 10,
            1998 (incorporated by reference to Exhibit 10.4 to the March
            1998 8-K).
 10.37      Stock Pledge Agreement dated March 10, 1998 by and between
            the Registrant and Galen Partners III, L.P., as agent
            (incorporated by reference to Exhibit 10.5 to the March 1998
            8-K).
 10.38      Form of Irrevocable Proxy Agreement (incorporated by
            reference to Exhibit 10.6 to the March 1998 8-K).
 10.39      Agency Letter Agreement dated March 10, 1998 by and among
            the Purchasers a party to the Debenture and Warrant Purchase
            Agreement, dated March 10, 1998 (incorporated by reference
            to Exhibit 10.7 to the March 1998 8-K).
 10.40      Press Release of Registrant dated March 13, 1998
            (incorporated by reference to Exhibit 99.1 to the March 1998
            8-K).
 10.41      Current Report on Form 8-K as filed by the Registrant with
            the Securities and Exchange Commission on March 24, 1998.
 10.42      Letter Agreement between the Registrant and the U.S.
            Department of Justice dated March 27, 1998 relating to the
            restructuring of the fine assessed by the Department of
            Justice under the Plea Agreement dated June 21, 1993.
 10.43      Employment Agreement dated as of March 10, 1998 between the
            Registrant and Michael K. Reicher.
 10.44      Employment Agreement dated as of March 10, 1998 between the
            Registrant and Peter Clemens.
*10.45      Amended, Restated and Consolidated Bridge Loan Agreement
            dated as of December 2, 1998 between the Company, Galen
            Partners III, L.P., Galen Partners International III, L.P.,
            Galen Employee Fund III, L.P. and the other signatures
            thereto.
*10.46      First Amendment to Amended, Restated and Consolidated Bridge
            Loan Agreement dated December 7, 1998 between the Company
            and the lenders listed on the signature page thereto.
*10.47      Second Amendment to Amended, Restated and Consolidated
            Bridge Loan Agreement dated March 8, 1999 between the
            Company and the lenders listed on the signature page
            thereto.
*10.48      Form of 10% Convertible Secured Note due May 30, 1999.
*10.49      Form of Common Stock Purchase Warrant issued pursuant to be
            Amended, Restated and Consolidated Bridge Loan Agreement.
*10.50      Amended and Restated General Security Agreement dated
            December 2, 1998 between the Company and Galen Partners III,
            L.P., as Agent.
*10.51      Subordination Agreement dated December 2, 1998 between the
            Registrant and Galen Partners III, L.P., as Agent.
*10.52      Agency Letter Agreement dated December 2, 1998 by and among
            the lenders a party to the Amended, Restated and
            Consolidated Bridge Loan Agreement, as amended.
*10.53      Lease Agreement dated March 17, 1999 between the Registrant
            and Par Pharmaceuticals, Inc.

24

EXHIBIT
 NUMBER                               DOCUMENT
-------                               --------
*10.54      Lease Agreement dated September 1, 1998 between the
            Registrant and Crimson Ridge Partners.
*10.55      Manufacturing and Supply Agreement dated March 17, 1999
            between the Registrant and Par Pharmaceuticals, Inc.
*10.56      Halsey Drug Co., Inc. 1998 Stock Option Plan.
 21         Subsidiaries of the Registrant (incorporated by reference to
            Exhibit 22 to the 1993 Form 10-K).
*23.1       Consent of Grant Thornton LLP, independent certified public
            accountants.
*27         Financial Data Schedule, which is submitted electronically
            to the Securities and Exchange Commission for informational
            purposes only and not filed.


* Filed herewith.

25

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

HALSEY DRUG CO., INC.

                                          By: /s/ MICHAEL REICHER
                                            ------------------------------------
                                            Michael Reicher, President and
                                              Chief Executive Officer (Principal
                                              Executive
                                              Officer)

Date: March 31, 1999

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

/s/ WILLIAM G. SKELLY                                    Chairman and Director          March 31, 1999
-----------------------------------------------------
William G. Skelly

/s/ MICHAEL REICHER                                      President, Chief Executive     March 31, 1999
-----------------------------------------------------      Officer and Director
Michael Reicher                                            (Principal Executive
                                                           Officer)

/s/ PETER CLEMENS                                        Vice President, Chief          March 31, 1999
-----------------------------------------------------      Financial Officer
Peter Clemens                                              (Principal Financial and
                                                           accounting Officer) and
                                                           Director

/s/ ALAN J. SMITH                                        Director                       March 31, 1999
-----------------------------------------------------
Alan J. Smith

/s/ BRUCE F. WESSON                                      Director                       March 31, 1999
-----------------------------------------------------
Bruce F. Wesson

/s/ WILLIAM SUMNER                                       Director                       March 31, 1999
-----------------------------------------------------
William Sumner

/s/ SRINI CONJEEVARAM                                    Director                       March 31, 1999
-----------------------------------------------------
Srini Conjeevaram

/s/ ZUBEEN SHROFF                                        Director                       March 31, 1999
-----------------------------------------------------
Zubeen Shroff

26

INDEX TO FINANCIAL STATEMENTS

                                                                 PAGE
                                                                 ----
Report of Independent Certified Public Accountants..........  F-2
Consolidated Balance Sheets.................................  F-3
Consolidated Statements of Operations.......................  F-4
Consolidated Statement of Stockholders' Equity..............  F-5
Consolidated Statements of Cash Flows.......................  F-6
Notes to Consolidated Financial Statements..................  F-8 - F-24

F-1

REPORT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS

Board of Directors
Halsey Drug Co., Inc.

We have audited the accompanying consolidated balance sheets of Halsey Drug Co., Inc. and Subsidiaries as of December 31, 1998 and 1997, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1998. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Halsey Drug Co., Inc. and Subsidiaries as of December 31, 1998 and 1997, and the consolidated results of their operations and their consolidated cash flows for each of the three years in the period ended December 31, 1998, in conformity with generally accepted accounting principles.

GRANT THORNTON LLP

New York, New York
March 5, 1999

F-2

HALSEY DRUG CO., INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

                                                                  DECEMBER 31,
                                                              --------------------
                                                                1998        1997
                                                              --------    --------
                                                                 (IN THOUSANDS)
CURRENT ASSETS
  Cash......................................................  $  1,850    $     26
  Accounts receivable -- trade, net of allowances for
     doubtful accounts of $280 and $542 in 1998 and 1997,
     respectively...........................................     1,439          62
  Inventories...............................................     6,354       2,456
  Prepaid insurance and other current assets................       148         274
                                                              --------    --------
          Total current assets..............................     9,791       2,818
PROPERTY, PLANT AND EQUIPMENT, NET..........................     4,787       4,630
DEFERRED PRIVATE OFFERING COSTS.............................     1,335         219
                                                              --------    --------
                                                              $ 15,913    $  7,667
                                                              ========    ========

CURRENT LIABILITIES
  Notes payable.............................................  $ 10,850    $  4,825
  Bank overdraft............................................                   159
  Due to banks..............................................                 2,476
  Convertible subordinated debentures.......................                 2,244
  Accounts payable..........................................     1,834       6,086
  Accrued expenses..........................................     3,972       7,232
  Deferred gain.............................................                 1,900
  Other current liabilities.................................       300         200
                                                              --------    --------
     Total current liabilities..............................    16,956      25,122
LONG-TERM DEBT, NET.........................................    26,186
OTHER LIABILITIES...........................................     2,224       2,402
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (DEFICIT)
  Common stock -- $.01 par value; authorized, 40,000,000
     shares; issued 14,443,212 shares and 14,029,718 shares
     in 1998 and 1997, respectively.........................       144         140
  Additional paid-in capital................................    29,113      25,489
  Accumulated deficit.......................................   (57,221)    (44,497)
                                                              --------    --------
                                                               (27,964)    (18,868)
  Less treasury stock -- at cost (439,603 shares in 1998 and
     1997, respectively)....................................      (989)       (989)
                                                              --------    --------
                                                               (28,953)    (19,857)
                                                              --------    --------
                                                              $ 15,913    $  7,667
                                                              ========    ========

The accompanying notes are an integral part of these statements.

F-3

HALSEY DRUG CO., INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

                                                                    YEAR ENDED DECEMBER 31,
                                                             --------------------------------------
                                                                1998          1997          1996
                                                             ----------    ----------    ----------
                                                             (IN THOUSANDS, EXCEPT PER SHARE DATA)
Net sales..................................................   $  8,841      $  9,088      $ 12,379
Cost of goods sold.........................................     12,712        15,406        16,826
                                                              --------      --------      --------
     Gross margin..........................................     (3,871)       (6,318)       (4,447)
Research and development...................................        651           979         1,854
Selling, general and administrative expenses...............      8,078         6,308         7,486
                                                              --------      --------      --------
     Loss from operations..................................    (12,600)      (13,605)      (13,787)
Interest expense...........................................     (1,946)       (1,144)       (1,708)
Other income (expense).....................................      1,802          (264)        1,000
                                                              --------      --------      --------
     NET LOSS..............................................   $ 12,724      $(15,013)     $(14,495)
                                                              ========      ========      ========
Basic loss per common share................................   $   (.92)     $  (1.12)     $  (1.49)
                                                              ========      ========      ========
Weighted average number of outstanding shares..............     13,813        13,434         9,724
                                                              ========      ========      ========

The accompanying notes are an integral part of these statements.

F-4

HALSEY DRUG CO., INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
YEARS ENDED DECEMBER 31, 1998, 1997 AND 1996

                                          COMMON STOCK,                               TREASURY STOCK,
                                         $.01 PAR VALUE    ADDITIONAL                     AT COST
                                         ---------------    PAID-IN     ACCUMULATED   ----------------
                                         SHARES   AMOUNT    CAPITAL       DEFICIT     SHARES   AMOUNT     TOTAL
                                         ------   ------   ----------   -----------   ------   -------   --------
                                                                      (IN THOUSANDS)
Balance at January 1, 1995.............   8,974    $ 90     $14,459      $(14,989)      (500)  $(1,100)  $ (1,540)
Issuance of common stock conversion of
  debentures...........................   3,504      35       6,724                                         6,759
Issuance of shares as settlement.......      60                 262                       25        56        318
Issuance of warrants with convertible
  subordinated debentures..............                         355                                           355
Exercise of warrants of convertible
  debentures...........................     589       6       1,363                                         1,369
Stock options exercised................      49                 153                                           153
Net loss for the year ended December
  31, 1996.............................                                   (14,495)                        (14,495)
                                         ------    ----     -------      --------     ------   -------   --------
Balance at December 31, 1996...........  13,176     131      23,316       (29,484)      (475)   (1,044)    (7,081)
Issuance of common stock -- conversion
  of debentures........................     643       7       1,529                                         1,536
Issuance of shares as payment of
  interest.............................      69       1         224                                           225
Sale of treasury stock.................      25                  45                       35        55        100
Exercise of warrants of convertible
  debentures...........................      22                  72                                            72
Stock options exercised................      95       1         303                                           304
Net loss for the year ended December
  31, 1997.............................                                   (15,013)                        (15,013)
                                         ------    ----     -------      --------     ------   -------   --------
Balance at December 31, 1997...........  14,030     140      25,489       (44,497)      (440)     (989)   (19,857)
Issuance of common stock -- conversion
  of notes payable.....................     110       1         213                                           214
Issuance of shares as payment of
  interest.............................     263       3         592                                           595
Issuance of common stock -- settlement
  of trade payables....................      40                  55                                            55
Deferred debt discount on warrants
  issued with convertible debentures...                       2,264                                         2,264
Net loss for the year ended December
  31, 1998.............................                                   (12,724)                        (12,724)
                                         ------    ----     -------      --------     ------   -------   --------
Balance at December 31, 1998...........  14,443    $144     $28,613      $(57,221)      (440)  $  (989)  $(29,453)
                                         ======    ====     =======      ========     ======   =======   ========

The accompanying notes are an integral part of this statement.

F-5

HALSEY DRUG CO., INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

                                                                 YEAR ENDED DECEMBER 31,
                                                             --------------------------------
                                                               1998        1997        1996
                                                             --------    --------    --------
                                                                      (IN THOUSANDS)
Cash flows from operating activities
  Net loss.................................................  $(12,724)   $(15,013)   $(14,495)
  Adjustments to reconcile net loss to net cash used in
     operating activities
     Depreciation and amortization.........................     1,774       1,733       1,906
     Provision for losses on accounts receivable...........      (262)        118         144
     Provision for loss on investment......................                               500
     (Gain) loss on disposal of assets.....................       170          38      (1,000)
     Changes in assets and liabilities
       Accounts receivable.................................    (1,115)         45       1,319
       Inventories.........................................    (3,898)      1,302       3,958
       Prepaid insurance and other current assets..........       126         165         (96)
       Accounts payable....................................    (4,197)      1,851       1,029
       Deferred gain.......................................    (1,900)
       Accrued expenses....................................    (2,665)      4,553       2,913
                                                             --------    --------    --------
     Total adjustments.....................................   (11,967)      9,805      10,673
                                                             --------    --------    --------
     Net cash used in operating activities.................   (24,691)     (5,208)     (3,822)
                                                             --------    --------    --------
Cash flows from investing activities
  Capital expenditures.....................................    (1,545)        (85)       (390)
  Net proceeds from sale of assets.........................        96
  Collection of notes receivable...........................                 1,000
                                                             --------    --------    --------
     Net cash (used in) provided by investing activities...    (1,449)        915        (390)
                                                             --------    --------    --------
Cash flows from financing activities
  Proceeds from issuance of notes payable..................  $  6,495    $  3,881    $     25
  Proceeds from issuance of common stock...................                               318
  Reissuance of treasury stock.............................                    70
  Payments to Department of Justice........................      (178)
  Bank overdraft...........................................      (159)       (127)         73
  Due to banks.............................................    (2,476)
  Payments to minority stockholders........................                              (206)
  Proceeds from issuance of convertible subordinated
     debentures............................................    25,800                   2,500
  Proceeds from exercise of stock options and warrants.....                   305         153
  Proceeds from exercise of warrants.......................                    72       1,369
  Deferred private offering costs..........................    (1,518)                   (255)
                                                             --------    --------    --------
     Net cash provided by financing activities.............    27,964       4,201       3,977
                                                             --------    --------    --------
     NET (DECREASE) INCREASE IN CASH AND CASH
       EQUIVALENTS.........................................     1,824         (92)       (235)
Cash and cash equivalents at beginning of year.............        26         118         353
                                                             --------    --------    --------
Cash and cash equivalents at end of year...................  $  1,850    $     26    $    118
                                                             ========    ========    ========

F-6

HALSEY DRUG CO., INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS -- (CONTINUED)
YEAR ENDED DECEMBER 31,
(IN THOUSANDS)

Supplemental disclosures of noncash activities:

Year ended December 31, 1998

1. The Company issued 262,836 shares of common stock as payment for $593,313 in accrued interest.

2. The Company reissued 20,000 shares of common stock as payment for $25,000 in legal fees and 20,000 shares of common stock as payment for $30,000 in trade payables.

3. The Company issued 110,658 shares of common stock as payment of outstanding notes payable in amounts of $214,000 and $1,782 in accrued interest.

4. The Company issued approximately 4,202,020 warrants (Note A) and 1,009,909 warrants (Note A) valued and recorded in aggregate as $3,118,000 of unamortized debt discount and a reduction in the related amount of the obligation.

Year ended December 31, 1997

1. The Company issued 642,407 shares of common stock to Zatpack, Inc. as payment for an outstanding note payable in the amount of $1,536,000.

2. The Company reissued 25,000 shares of treasury stock as payment for $30,000 in consulting fees and the receipt of $70,000 in cash.

3. The Company issued 25,000 shares of common stock as payment for $225,452 in accrued interest.

4. The Company recorded the satisfaction of $1,400,000 of subordinated promissory notes, related accrued interest of $200,000 and accounts payable of $300,000 due to Mallinckrodt, in lieu of Mallinckrodt paying $1,900,000 owed to the Company as described in Note E.

Year ended December 31, 1996

1. The issuance of 3,504,000 shares of the Company's common stock upon conversion of $6,759,000 of convertible subordinated debentures is included in common stock and additional paid-in capital.

2. The valuation of the warrants issued in 1996 of $355,000 with convertible subordinated debentures is included in additional paid-in capital.

3. The issuance in 1996 of 59,550 shares of the Company's common stock is valued at $318,000 in connection with litigation settlements.

The accompanying notes are an integral part of these statements.

F-7

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 1998, 1997 AND 1996

NOTE A -- SUMMARY OF ACCOUNTING POLICIES

Halsey Drug Co., Inc. (the "Company"), a New York-based corporation established in 1935, and its subsidiaries are engaged in the manufacture, sale and distribution of generic drugs. The Company sells its generic drug products under its Halsey label and under private-label arrangements with drug store chains and drug wholesalers throughout the United States.

A summary of the significant accounting policies consistently applied in the preparation of the accompanying consolidated financial statements follows.

1. Principles of Consolidation and Basis of Presentation

The consolidated financial statements include 100% of the accounts of the Company and its wholly-owned subsidiaries, Blue Cross Products Co., Inc., Houba, Inc., Halsey Pharmaceuticals, Inc., and Indiana Fine Chemicals Corporation, The Medi-Gum Corporation (100% owned). The Medi-Gum Corporation and Halsey Pharmaceuticals have not commenced operations. All material intercompany accounts and transactions have been eliminated.

2. Liquidity Matters

As of December 31, 1998, the Company has a working capital deficiency of approximately $6,665,000, has an accumulated deficit of approximately $57,221,000 and has incurred a loss of approximately $12,724,000 for the year then ended.

On March 10, 1998, the Company completed a private offering (the "Offering") of securities to an investor group ("Galen") consisting of 5% convertible senior secured debentures due March 15, 2003, and common stock purchase warrants (with a 5 year life) exercisable for 2,101,010 shares of the Company's common stock at an exercise price of $1.50 and 2,101,010 shares at an exercise price of $2.375. The unamortized discount resulting from the issuance of such warrants ($2,618,000) has Been recorded as a reduction of the related obligation. The net proceeds to the Company from the Offering, after the deduction of related offering expenses, was approximately $19.6 million. In addition, in accordance with the terms of the private offering, during June 1998, Galen invested an additional $5 million in the Company in exchange for debentures and warrants having terms identical to those issued in the Offering.

The net proceeds from the Offering and the additional investment have primarily been used to satisfy a substantial portion of the Company's liabilities and accounts payable. Such liabilities include the full satisfaction of the Company's bank indebtedness and related fees, payment to the landlord of the Brooklyn facility and satisfaction of outstanding judgments and liens. Further, pursuant to agreements reached with other large creditors in anticipation of the completion of the offering, including the Company's landlord and the Department of Justice ("DOJ"), the Company has been able to bring these creditors current and bring the Company in compliance with installment payment agreements providing more favorable terms to the Company. The offering proceeds also allowed the Company to satisfy its outstanding state and Federal payroll tax obligations and meet current payroll tax obligations. The net proceeds from the exercise of the option were used to fund working capital, including the purchase of raw materials, payroll expenses and other Company expenses.

The Company secured bridge financing from Galen and certain investors in the Offering in the aggregate amount of $9,504,111, funded through seven separate bridge loan transactions between the period from August through and including December 1998, as well as an additional bridge loan in March 1999 (collectively, the "Bridge Loans"). The Bridge Loans were consolidated on December 2, 1998 pursuant to an Amended, Restated and Consolidated Bridge Loan Agreement, as amended to permit the March 1999 bridge loan (the "Consolidated Bridge Loan"). The Consolidated Bridge Loan bears interest at 10% per annum, is

F-8

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

secured by a first lien on all of the Company's assets and has a maturity date of May 30, 1999. Approximately $9,120,000 in the principal amount of the Consolidated Bridge Loan was advanced by Galen with the balance of approximately $384,000 advanced by certain investors in the Offering. The Consolidated Bridge Loan is evidenced by 10% convertible senior secured promissory notes which are convertible at any time prior to maturity into shares of the Company's Common Stock at a conversion price of approximately $1.368 per share with respect to approximately $7,820,000 of such indebtedness, $1.331 per share with respect to approximately $284,000 of such indebtedness, and $1.197 per share with respect to approximately $1,400,000 of such indebtedness, for an aggregate of 7,099,338 shares of common stock (such conversion prices equal the fair market value of the Common Stock at the date of issuance of the convertible promissory notes). In addition, in consideration for the initial extension of the Bridge Loans and the extension of the maturity dates of the Bridge Loans pursuant to the consolidation of such loans on December 2, 1998, as amended to permit the March 1999 bridge loan, the Company issued common stock purchase warrants to Galen and the other investors in the Consolidated Bridge Loan, to purchase an aggregate of approximately 1,009,909 shares of the Company's common stock (representing warrants to purchase 50,000 shares of Common Stock for each $1,000,000 in principal amount of Bridge Loan having a term of 90 days from the date of the making of the Bridge Loan). The unamortized discount resulting form the issuance of such warrants ($500,000) has been recorded as a reduction of the related obligation. The Bridge Loan warrants are substantially identical to those issued by the Company in its Debenture and Warrant Offering completed on March 10, 1998.

The Consolidated Bridge Loan was obtained by the Company in order to provide necessary working capital. In view of the Company's current cash reserves and projections for revenues through May 30, 1999, the Company will be unable to satisfy the Consolidated Bridge Loan in full at the stated maturity date of May 30, 1999. Galen, the holder of approximately 96% of such indebtedness, has indicated to the Company a willingness to cooperate in the restructuring of the indebtedness evidenced by the Consolidated Bridge Loan to extend the maturity date of such debt and/or convert the debt into common stock or longer-term convertible indebtedness. The terms of such restructuring will depend, to a large extent, on the terms and timing of any third-party investment, as described below. Accordingly, the terms of any such restructuring have yet to be agreed to by the parties and will be subject to the negotiation and preparation of definitive agreements.

The Company is in preliminary discussions with an unaffiliated third party concerning the terms of a proposed investment in the Company in an amount of up to $15 million, to be funded in three equal increments based on the achievement of certain milestones. The structure of the investment will likely take the form of convertible debentures and common stock purchase warrants, similar in many respects to the debentures and warrants issued by the Company in its March 10, 1998 offering. The discussions with this third-party investor are in the preliminary stages and no assurance can be given that final terms acceptable to the Company will result and/or that if consummated, that the Company will be successful in achieving the milestones necessary to fund all or any portion of the proposed investment.

In the event the Company is successful in restructuring the Consolidated Bridge Loan and completing the third-party investment of the type and size described above, the Company will have sufficient cash reserves to satisfy its working capital requirements for at least the next twelve months. The Company is also seeking to secure a senior revolving line of credit from a banking institution. There can be no assurance, however, that the Company will be able to obtain such third-party investment or a bank facility. If the Company is unable to complete the third-party investment described above or obtain other sources of working capital, including a bank line of credit or proceeds from the issuance of debt and/or equity securities, the Company's cash reserves will be sufficient to satisfy the Company's working capital requirements for approximately two to three months. Failure to obtain a third-party investment of the type described above, a bank line of credit or alternative sources of financing of a comparable amount in the near term will materially adversely affect the Company's working capital position and financial condition and results of operations.

F-9

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

3. Inventories

Inventories are stated at the lower of cost or market; cost is determined using the first-in, first-out method.

4. Property, Plant and Equipment

Property, plant and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization are provided for in amounts sufficient to relate the cost of depreciable assets to operations over their estimated service lives, principally on a straight-line basis. The estimated lives used in determining depreciation and amortization are:

Buildings...................................................    25 years
Machinery and equipment.....................................  5-10 years
Leasehold improvements......................................  5-10 years

Leasehold improvements are amortized over the lives of the respective leases or the service lives of the improvements, whichever is shorter.

5. Income Taxes

The Company accounts for income taxes utilizing an asset liability method for financial accounting and reporting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.

6. Statements of Cash Flows

For purposes of the statements of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. The Company paid no substantial income taxes for the years ended December 31, 1998, 1997 and 1996. In addition, the Company paid interest of approximately $1,946,000, $1,113,000, $1,173,000, respectively, for the years ended December 31, 1998, 1997 and 1996.

7. Use of Estimates in Consolidated Financial Statements

In preparing consolidated financial statements in conformity with generally accepted accounting principles, management makes estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

8. Research and Development Costs

All research and development costs, including payments related to licensing agreements on products under development and research consulting agreements are expensed when incurred.

9. Impairment of Long-Lived Assets

The Company reviews long-lived assets and certain identifiable intangibles held and used for possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable (Note I).

F-10

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

10. Stock-Based Compensation

The Company accounts for stock-based compensation under Statement of Financial Accounting Standards No. 123 ("SFAS No. 123"), "Accounting for Stock-Based Compensation," and continues to apply APB Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations in accounting for its plans and does not recognize compensation expense for its stock-based compensation plans other than for restricted stock (Note K).

Equity instruments issued to nonemployees in exchange for goods and/or services are accounted for under the fair value method of SFAS No. 123.

11. New Pronouncements

Earnings (Loss) Per Share

In 1997, the Company adopted Statement of Financial Accounting Standards No. 128 ("SFAS No. 128"), "Earnings Per Share," which requires public companies to present basic earnings (loss) per share and, if applicable, diluted earnings per share. All comparative periods have been restated in accordance with SFAS No. 128.

The computation of basic earnings (loss) per share of common stock is based upon the weighted average number of common shares outstanding during the period. Diluted earnings per share is equal to basic earnings per share for all years presented as the effect of other potentially dilutive securities would be antidilutive.

Reporting Comprehensive Income

In June 1997, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards No. 130 ("SFAS No. 130"), "Reporting Comprehensive Income," which is effective for the Company's year ended December 31, 1998. The statement addresses the reporting and displaying of comprehensive income and its components. Earnings per share is only reported for net income and not for comprehensive income and its components. At December 31, 1998, 1997 and 1996, the Company had no items of other comprehensive income.

12. Reclassifications

Certain reclassifications have been made to the 1997 and 1996 presentations to conform to the 1998 presentation.

NOTE B -- FAIR VALUE OF FINANCIAL INSTRUMENTS

Long-term and Short-term Debt and Convertible Subordinated Debentures

The fair value of the Company's long-term and short-term debt and convertible subordinated debentures is estimated based upon the quoted market prices for the same or similar issues or on the current rates offered to the Company for debt of the same outstanding maturities. Accordingly, the carrying amount of these financial instruments approximates their fair value at December 31, 1998 and 1997.

F-11

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

NOTE C -- INVENTORIES

Inventories consist of the following:

                                                                DECEMBER 31,
                                                              ----------------
                                                               1998      1997
                                                              ------    ------
                                                               (IN THOUSANDS)
Finished goods..............................................  $2,675    $  789
Work-in-process.............................................   1,166       263
Raw materials...............................................   2,513     1,404
                                                              ------    ------
                                                              $6,354    $2,456
                                                              ======    ======

NOTE D -- PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment are summarized as follows:

                                                                 DECEMBER 31,
                                                              ------------------
                                                               1998       1997
                                                              -------    -------
                                                                (IN THOUSANDS)
Machinery and equipment.....................................  $12,278    $11,478
Leasehold improvements......................................    6,103      5,967
Building....................................................      747        997
Land........................................................       44        265
                                                              -------    -------
                                                               19,172     18,707
Less accumulated depreciation and amortization..............   14,385     14,077
                                                              -------    -------
                                                              $ 4,787    $ 4,630
                                                              =======    =======

Depreciation expense for the years ended December 31, 1998, 1997 and 1996 was approximately $1,122,000, $1,640,000, and $1,562,000, respectively.

NOTE E -- DEBT

Due to Banks

At December 31, 1997 the Company had $2,476,000 under a line of credit agreement with three participating banks for which the average borrowing rate for the year then ended was 11.9 %. The agreement contained certain financial covenants, for which the Company was not in compliance at December 31, 1997. During March 1998, the Company completely satisfied its bank indebtedness and terminated the line of credit agreement with its banks.

Notes Payable

At December 31, 1998 and 1997, notes payable consisted of the following:

                                                                DECEMBER 31,
                                                              -----------------
                                                               1998       1997
                                                              -------    ------
                                                               (IN THOUSANDS)
Unsecured promissory demand notes...........................  $ 2,817
Subordinated promissory notes...............................             $4,825
Bridge Loans (Note A).......................................    7,533
                                                              -------    ------
                                                              $10,350    $4,825
                                                              =======    ======

F-12

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

During 1997, the Company borrowed from and issued to several debenture holders and shareholders unsecured, demand promissory notes in the amount of $1,125,000, bearing interest at 12% per annum, with interest payable quarterly. These notes were paid in full in 1998.

During the period from May 1997 through July 1997, the Company borrowed approximately $3 million from Mylan Laboratories, Inc. ("Mylan") pursuant to five unsecured, demand promissory notes. The advances made by Mylan Laboratories, Inc. were part of a proposed investment by Mylan in the Company, including the proposed purchase of the Company's Houba Indiana facility as well as a partial tender offer for the Company's common stock. The Company used the proceeds of these borrowings for working capital. To date, $236,000 has been paid by the Company to Mylan against such indebtedness in the form of product deliveries to Mylan. Pursuant to an agreement reached between the parties, the Company is required to satisfy interest on the outstanding indebtedness on an annual basis while the indebtedness remains outstanding and to satisfy the principal amount of such indebtedness in the form of product deliveries to Mylan until such time as the indebtedness is satisfied in full. In 1998, the Company, in exchange for extending the loan, agreed to grant a warrant to purchase 50,000 shares of the Company's common stock at a price of $1.94 per share.
Additionally, the Company began reducing the loan by supplying product to Mylan. At December 31, 1998, the loan balance was $2,817,000.

During the fourth quarter of 1997, the Company received $500,000 from an investor of a proposed joint venture, a demand promissory note bearing interest at 10% per annum which was secured by the property of Houba. In addition, as part of a proposed financing agreement, the Company received $200,000 as a promissory note bearing interest at 8% per annum during the fourth quarter of 1997. Both of these promissory notes were paid in full in 1998.

NOTE F -- CONVERTIBLE SUBORDINATED DEBENTURES AND STOCK WARRANTS

In connection with certain 1995 amendments to the line of credit agreement described in Note E, the Company issued stock warrants to the bank, expiring July 17, 2000, to purchase up to 699,696 shares of the Company's common stock at exercise prices ranging from $1.98 to $2.07 per share. The fair value of the warrants, $200,000, as determined by the Company's Board of Directors, was recorded by the Company in 1994 as additional paid-in capital and a discount to bank debt which was fully amortized through the maturity date, August 31, 1995.

On July 18, 1995, the Company issued 408 units, at $10,000 per unit, in a private placement of its securities ("July Private Placement"). Each unit consisted of: (i) a 10% convertible subordinated debenture due July 18, 2000 in the principal amount of $10,000, interest payable quarterly, and convertible into shares of the Company's common stock at a conversion price of $2.00 per share, subject to antidilution provisions, and (ii) 750 redeemable common stock purchase warrants ("warrants"). Each warrant entitled the holder to purchase one share of common stock for $2.00, subject to adjustment during the five-year period commencing July 18, 1995. The warrants were redeemable by the Company at a price of $.01 per warrant at any time commencing July 18, 1996, provided that at July 18, 1996, the fair market value of the Company's common stock equals or exceeds $2.00 per share for the 20 consecutive trading days ending on the third day prior to the notice of redemption to the holders of the warrant. The debentures were converted into 2,040,000 shares of common stock in August 1996.

On November 29, 1995, the Company issued 366 units, at $10,000 per unit, in a private placement of its securities ("November Private Placement"). Each unit consisted of (i) a 10% convertible subordinated debenture due November 29, 2000 in the principal amount of $10,000, interest payable quarterly, and convertible into shares of the common stock, at a conversion price of $2.50 per share, subject to dilution, and (ii) 600 redeemable common stock purchase warrants. The terms and conditions of the warrants issued in connection with the November Private Placement are similar to those issued in the July Private Placement,

F-13

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

except that the exercise price of the warrant pursuant to the November Private Placement is $2.50 per share. These debentures were converted into 1,464,000 shares of common stock in December 1996.

On August 6, 1996, the Company issued 250 units, at $10,000 per unit, in a private placement of its securities ("August Private Placement"). Each unit consisted of: (i) a 10% convertible subordinated debenture due August 6, 2001 in the principal amount of $10,000, interest payable quarterly, and convertible into shares of the Company's common stock at a conversion price of $3.25 per share, subject to dilution, and (ii) 750 redeemable common stock purchase warrants ("warrants"). Each warrant entitled the holder to purchase one share of common stock for $3.25, subject to adjustment during the five-year period commencing August 6, 1996. Pursuant to the agreement, the Company was required to establish an escrow account to repay interest in the outstanding convertible debenture, which was fully paid during 1997.

NOTE G -- ACCRUED EXPENSES

Accrued expenses are summarized as follows:

                                                                DECEMBER 31,
                                                              ----------------
                                                               1998      1997
                                                              ------    ------
                                                               (IN THOUSANDS)
Payroll taxes payable (Note H)..............................  $1,714    $3,290
Interest....................................................     619     1,018
Professional fees...........................................     539       537
Accrued pension and welfare.................................      15       501
Medicaid rebates payable....................................     169       481
Accrued payroll.............................................      92       420
Directors' fees.............................................     126        90
New York State Department of Education......................     140       134
Medical claims..............................................     149
Commissions.................................................      30        42
Property taxes..............................................      94
Accrued chargeback liability................................      40
Accrued equipment purchase..................................      56
Other.......................................................     189       719
                                                              ------    ------
                                                              $3,972    $7,232
                                                              ======    ======

At December 31, 1998, payroll taxes payable include approximately $1,373,000 and $275,000 of delinquent payroll taxes (including penalties and interest) due to the Internal Revenue Service and the State of New York, respectively, all of which liability was incurred in 1997 and 1996. The Company expects that the Federal liability will be substantially offset by income tax refund claims which were filed and are pending before the IRS. Until such time as the IRS completes its review, the Company has not recorded any expected tax refund claims. The Company has negotiated a payment plan with the State of New York and the balance will be paid by the end of 1999.

F-14

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

NOTE H -- INCOME TAXES

The actual income tax expense varies from the Federal statutory rate applied to consolidated operations as follows:

                                                       YEAR ENDED DECEMBER 31,
                                       --------------------------------------------------------
                                             1998                1997                1996
                                       ----------------    ----------------    ----------------
                                       AMOUNT       %      AMOUNT       %      AMOUNT       %
                                       -------    -----    -------    -----    -------    -----
                                                            (IN THOUSANDS)
Federal statutory rate...............  $(4,326)   (34.0)%  $(5,105)   (34.0)%  $(4,928)   (34.0)%
Loss for which no tax benefit was
  provided...........................    4,247     33.8      4,924     32.8      4,233     29.1
Losses of subsidiaries with no tax
  benefit............................                                              424      3.0
Amortization of Warrants.............                           24       .2         32       .2
Goodwill amortization................                           12       .1         73       .5
Department of Justice settlement.....       42       .1                             57       .4
Other................................       37       .1        145       .9        109       .8
                                       -------    -----    -------    -----    -------    -----
Actual tax expense...................  $    --       --%   $    --       --%   $    --       --%
                                       =======    =====    =======    =====    =======    =====

The Company has net operating loss carryforwards aggregating approximately $45,572,700, expiring during the years 2011 through 2018. In addition, certain of the Company's subsidiaries filed separate Federal income tax returns in prior years and have separate net operating loss carryforwards aggregating approximately $4,062,758 expiring during the years 1999 through 2018.

The tax loss carryforwards of the Company and its subsidiaries are subject to limitation by Section 382 of the Internal Revenue Code with respect to the amount utilizable each year. This limitation reduces the Company's ability to utilize net operating loss carryforwards included above each year. The amount of the limitation has not been quantified by the Company.

F-15

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

The components of the Company's deferred tax assets (liabilities), pursuant to SFAS No. 109, are summarized as follows:

                                                                  DECEMBER 31,
                                                              --------------------
                                                                1998        1997
                                                              --------    --------
                                                                 (IN THOUSANDS)
Deferred tax assets
  Net operating loss carryforwards..........................  $ 21,831    $ 15,125
  Allowance for doubtful accounts...........................        75         304
  Research and development tax credit.......................       212         212
  Reserve for inventory.....................................       169         886
  Litigation settlement.....................................        73         195
  Rent......................................................       231         172
  Reserve for Medicaid......................................        71         209
  Capital loss carryforwards................................                   210
  Reserve for property, plant and equipment.................                   111
  Other.....................................................        15          24
                                                              --------    --------
     Gross deferred tax assets..............................    22,677      17,448
                                                              --------    --------
Deferred tax liabilities
  Depreciation..............................................      (332)       (828)
  Installment sale gain.....................................                  (798)
  Other.....................................................       (42)        (42)
                                                              --------    --------
                                                                  (374)     (1,668)
                                                              --------    --------
     Net deferred tax assets before valuation allowance.....    22,303      15,780
Valuation allowance.........................................   (22,303)    (15,780)
                                                              --------    --------
     Net deferred tax assets................................  $     --    $     --
                                                              ========    ========

SFAS No. 109 requires a valuation allowance against deferred tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets may not be realized. The valuation allowance at December 31, 1998 primarily pertains to uncertainties with respect to future utilization of net operating loss carryforwards.

NOTE I -- OTHER INCOME (EXPENSE)

Cessation of California Operations

During 1997, management decided to shut down its California operations which comprised two of its subsidiaries, Cenci Powder Products, Inc. and H.R. Cenci Laboratories, Inc. The Company had not incurred any significant costs to exit these operations other than minimal vacation compensation and salary paid to a former plant employee to manage the exit process. Continuing operating losses and the inability to leverage the manufacturing capacity were among factors considered by the Board and Management in their determination to cease such operations.

At December 31, 1997, the net assets of H.R. Cenci Laboratories, Inc., consisted primarily of building, equipment and land with a net carrying value of $528,000 and inventory with a total net carrying value of $93,000. Accordingly, during 1997 the Company recorded a charge of $264,000 to reduce the fixed assets to their then estimated net realizable value, and a $93,000 charge to write off the remaining inventory. In 1998,

F-16

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

the Company disposed of the remaining assets and recorded a charge of $191,000. For the years ended December 31, 1998, 1997 and 1996, these subsidiaries, in aggregate, accounted for revenues of approximately $160,000, $495,000, and $290,000, respectively.

On March 30, 1998, the Company completed the sale of substantially all of the non-real property assets of Cenci Powder Products to Zuellig Botanical. The purchase price for the assets consisted of the forgiveness by Zuellig Botanical of approximately $262,000 in indebtedness owed by Cenci Powder to Zuellig Botanical related to the purchase of raw materials. The Agreement provided further that Zuellig Botanical would satisfy the manufacture and delivery requirements of Cenci Powder at its facility located at Fresno, California, under an existing third party supply contract.

Sale of Assets

On March 21, 1995, the Company sold its Abbreviated New Drug Application ("ANDA") for 5mg Oxycodone HCL/325mg Acetaminophen Tablets ("Tablets") and certain equipment used in the production of the Tablets for up to $5.4 million to Mallinckrodt. The Company received $500,000 of the proceeds in July 1994, which was recorded as deferred income on the Company's 1994 consolidated balance sheet. Mallinckrodt also paid the Company $2,000,000 on March 21, 1995 and the remainder was to be payable as follows: (i) $1,000,000 upon the Company receiving general clearance from the FDA for unrestricted operations at its Brooklyn facility and written notice from the FDA that it is in compliance with certain provisions of the consent degree dated June 29, 1993 and (ii) $1,900,000 at the earlier of (a) Mallinckrodt receiving certain authorizations from the FDA or (b) September 21, 1997. Mallinckrodt also agreed to defer $1,200,000 of the Company's trade debt due to an affiliate of Mallinckrodt (Note E). Pursuant to the release of the Company from the FDA's Application Integrity Policy list and its Restrictions (collectively, the "AIP") by the FDA on December 19, 1996, the Company recorded a gain of $1,000,000. On January 9, 1997, Mallinckrodt tendered this amount to the Bank Group. Pursuant to the agreement of September 21, 1997, the Company recorded $1,900,000 as a deferred gain which was recognized on March 21, 1998.

In connection with the agreement, the Company agreed to manufacture Tablets for Mallinckrodt for a period of three years and Mallinckrodt agreed to order a minimum number of Tablets from the Company for two years ending March 21, 1997. The Company and Mallinckrodt entered into a noncompetition agreement pursuant to which the Company agreed not to compete with Mallinckrodt and its affiliates with respect to the Tablets until March 21, 2000.

NOTE J -- PENSION EXPENSE

1. Management Pension Plan

The Company had maintained a defined benefit plan covering substantially all nonunion employees which was terminated in November 1996. Subsequently, all Plan assets were converted to cash and held in a money market fund (to continue the Trust) from which all vested participant interests were to be paid. Based on information provided by the Company's actuary, the total liability of the Plan as of the plan year ended November 30, 1997 was $398, 281. The actuary determined that this amount was sufficient to pay the vested interests of all of the participants who were in the Plan as of November 30, 1996, and for any participants who had terminated with previously vested interests that had not yet been paid. Included in the Plan's assets as of November 30, 1997, were receivables from the Company and the Insurer for $54,631 and $57,468, respectively, which were subsequently paid in March 1998. No additional contributions were required to be paid to the Trust for the period ended November 30, 1997.

In 1998 the Company received approval to terminate the Plan by the Pension Benefit Guarantee Corporation, all assets were distributed to the vested participants, the Trust was terminated and a final filing was made with the Internal Revenue Service.

F-17

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

2. Employees' Pension Plan

The Company contributed approximately $421,000, $407,000, and $492,000 in 1998, 1997 and 1996, respectively, to a multiemployer pension plan for employees covered by collective bargaining agreements. This plan is not administered by the Company and contributions are determined in accordance with provisions of negotiated labor contracts. Information with respect to the Company's proportionate share of the excess, if any, of the actuarially computed value of vested benefits over the total of the pension plan's net assets is not available from the plan's administrator.

The Multiemployer Pension Plan Amendments Act of 1980 (the "Act") significantly increased the pension responsibilities of participating employers. Under the provision of the Act, if the plans terminate or the Company withdraws, the Company could be subject to a "withdrawal liability."

NOTE K -- STOCK OPTION PLAN

In June 1998, the stockholders of the Company approved the adoption of a stock option and restricted stock purchase plan (the "1998 Option Plan"). The 1998 Option Plan replaces the 1995 Option Plan which was terminated in 1998. The 1998 Option Plan provides for the granting of (i) nonqualified options to purchase the Company's common stock at not less than the fair market value on the date of the option grant, (ii) incentive stock options to purchase the Company's common stock at not less than the fair market value on the date of the option grant and (iii) rights to purchase the Company's common stock on a "Restricted Stock" basis, as defined, at not less than the fair market value on the date the right is granted. As of December 31, 1998, there was no exercise of rights to purchase any common stock on a restricted stock basis. The total number of shares which may be sold pursuant to options and rights granted under the 1998 Option Plan is 2,600,000. No option can be granted under the 1998 Option Plan after April, 2008 and no option can be outstanding for more than ten years after its grant.

The Company has adopted the disclosure provisions of Statement of Financial Accounting Standards No. 123 ("SFAS No. 123"), "Accounting for Stock-Based Compensation." It applies APB Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations in accounting for its plans and does not recognize compensation expense for its stock-based compensation plans other than for restricted stock. If the Company had elected to recognize compensation expense based upon the fair value at the grant date for awards under these plans consistent with the methodology prescribed by SFAS No. 123, the Company's net income and earnings per share would be reduced to the pro forma amounts indicated below:

                                                            YEAR ENDED DECEMBER 31,
                                                     --------------------------------------
                                                        1998          1997          1996
                                                     ----------    ----------    ----------
                                                     (THOUSANDS, EXCEPT PER SHARE AMOUNTS)
Net loss
  As reported......................................   $(12,724)     $(15,013)     $(14,495)
  Pro forma........................................    (13,663)      (15,323)      (14,180)
Loss per share
  As reported......................................   $   (.92)     $  (1.12)     $  (1.49)
  Pro forma........................................       (.98)        (1.14)        (1.46)

These pro forma amounts may not be representative of future disclosures because they do not take into effect pro forma compensation expenses related to grants made before 1995. The fair value of these options was estimated at the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions for the years ended December 31, 1998, 1997 and 1996, respectively: expected volatility of 67%, 65%, and 82% ; risk-free interest rates of 5.6%, 6.0%, and 6.6% ; and expected lives of 10 years, 4 years and 4.6 years. At the date of grant, all exercise prices equaled the market value of the stock.

F-18

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company's employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair market estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.

Transactions involving stock options are summarized as follows:

                                                                      WEIGHTED    WEIGHTED
                                                          STOCK       AVERAGE     AVERAGE
                                                         OPTIONS      EXERCISE      FAIR
                                                       OUTSTANDING     PRICE       VALUE
                                                       -----------    --------    --------
Balance at January 1, 1996...........................     600,500      $3.49
Granted..............................................     126,000       4.77
Exercised............................................     (49,159)      3.12
Cancelled............................................     (21,334)      4.39
                                                        ---------
Balance at December 31, 1996.........................     656,007       3.53
Exercised............................................     (89,300)      3.22       $3.39
Cancelled............................................     (84,968)      5.16        3.39
                                                        ---------
Balance at December 31, 1997.........................     481,739       3.60
                                                        =========
Granted..............................................   2,254,850       2.37        1.71
Cancelled............................................    (511,303)      3.16        2.08
                                                        ---------
Balance at December 31, 1998.........................   2,225,286       2.46
                                                        =========

The following table summarizes information concerning currently outstanding and exercisable stock options:

                            OPTIONS OUTSTANDING                OPTIONS EXERCISABLE
                  ---------------------------------------   -------------------------
                                    WEIGHTED
                      NUMBER         AVERAGE     WEIGHTED       NUMBER       WEIGHTED
                  OUTSTANDING AT    REMAINING    AVERAGE    EXERCISABLE AT   AVERAGE
   RANGES OF       DECEMBER 31,    CONTRACTUAL   EXERCISE    DECEMBER 31,    EXERCISE
EXERCISE PRICES        1998           LIFE        PRICE          1998         PRICE
---------------   --------------   -----------   --------   --------------   --------
 $1.19 - $2.00         70,000         8.10        $1.55          20,000       $1.97
  2.01 -  3.00      2,025,350         9.19         2.40         348,750        2.38
  3.01 -  4.88        129,936         7.32         3.86          80,036        3.74
                    ---------                                   -------
                    2,225,286                                   448,786
                    =========                                   =======

NOTE L -- COMMITMENTS

The Company occupies plant and office facilities under noncancellable operating leases which expire in December 2005. These operating leases provide for scheduled base rent increases over the term of the lease, however, the total amount of the base rent payments will be charged to operations using the straight-line method over the term of the lease. The leases provide for payment of real estate taxes based upon a percentage of the annual increase. In addition, the Company rents certain equipment under operating leases, generally for terms of four years. Total rent expense for the years ended December 31, 1998, 1997 and 1996 was approximately $1,243,000, $884,000 and $659,000, respectively.

F-19

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

As of December 31,1998, the approximate minimum rental commitments under these operating leases are as follows:

                                                 (IN THOUSANDS)
Twelve months ending December 31,
  1999.........................................      $1,023
  2000.........................................       1,075
  2001.........................................       1,128
  2002.........................................       1,186
  2003 and thereafter..........................       3,921
                                                     ------
     Total minimum payments required...........      $8,333
                                                     ======

Employment Contracts

During March 1998, the Company entered into employment contracts with each of two new officers/employees of the Company which cover a five-year and a three-year period, respectively. The contracts provide for, among other things:
(i) annual salaries of $170,000 and $140,000 to be paid over the five-year and three-year periods, respectively and (ii) an aggregate of 1,300,000 options (included in the 1998 grants -- Note K) to purchase the Company's stock at an exercise price of $2.38 per common share that vest evenly over a three-to-five-year service period and expire in ten years.

NOTE M -- CONTINGENCIES

The Company currently is a defendant in several lawsuits involving product liability and other claims. The Company's insurance carriers have assumed the defense for all product liability and other actions involving the Company. None of the lawsuits is brought as a class action. The ultimate outcome of these lawsuits cannot be determined at this time, and accordingly, no adjustment has been made to the consolidated financial statements.

On October 23, 1996, the Company withdrew four of its Abbreviated New Drug Applications ("ANDAs") including its ANDA for acetaminophen/oxycodone capsules (the "Capsule ANDA"), and halted sales of the affected products. The Company instituted the withdrawal at the suggestion of the FDA and in anticipation of its release from the FDA's Application Integrity Policy ("AIP"). The FDA has placed the Company on the AIP, in October 1991, in connection with its investigation of the Company's operations which culminated in the 1993 consent decree. Under the AIP, the FDA suspended all of the parent company's (i.e., Halsey Drug Co.'s) applications for new drug approvals, including ANDAs and supplements to ANDAs. At the FDA's suggestion, the Company retained outside consultants to perform validity assessments of its drug applications. Thereafter, in October 1996, the FDA recommended that several applications, including the Capsule ANDA, be withdrawn. As a basis of its decision, the FDA cited questionable and incomplete data submitted in connection with the applications. The FDA indicated that withdrawal of the four ANDAs was necessary for the release of the Company from the AIP. The FDA further required submission by the Company of a Corrective Action Plan. Said Plan was prepared and submitted by the Company and accepted by the FDA during 1997.

On December 19, 1996, the FDA released the Company from the AIP. As a consequence, for the first time since October 1991, the Company was permitted to submit ANDAs to the FDA for review. Since its release from the AIP in December 1996, through the fiscal year ended December 31, 1998, the Company submitted thirteen ANDAs for review by the FDA, including a new ANDA with respect to the Capsules. During the period from the Company's release from the AIP to March 15, 1999, the Company received six ANDA approvals, all of which relate to ANDA filings made with the FDA subsequent to the Company's release from the AIP.

As of March 15, 1999, the Company had submitted one additional ANDA for review by the FDA in fiscal 1999 and anticipates the submission of five additional ANDAs during the balance of fiscal 1999.

F-20

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

Although the Company has been successful in receiving the ANDA approvals described above since its release from the AIP in December 1996, there can be no assurance that any of its newly submitted ANDAs, or those contemplated to be submitted, will be approved by the FDA. The Company will not be permitted to market any new product unless and until the FDA approves the ANDA relating to such product. Failure to obtain FDA approval for the Company's pending ANDAs, or a significant delay in obtaining such approval, would adversely affect the Company's business operations and financial condition.

On June 21, 1993, the Company entered into a Plea Agreement with the DOJ to resolve the DOJ's investigation into the manufacturing and record keeping practices of the Company's Brooklyn plant. Under the terms of the Plea Agreement, the Company agreed to plead guilty to five counts of adulteration of drug products shipped in interstate commerce. Each count involved product adulteration, and record keeping deficiencies relating to a single drug product, Quinidine Gluconate (324mg tablets), manufactured at the Brooklyn plant. The Plea Agreement also required the Company to pay a fine of $2,500,000 over five years in quarterly installments of $125,000, commencing on or about September 15, 1993. The Company's plea was entered and the terms of the Plea Agreement were approved by the United States District Court for the District of Maryland on July 13, 1993. As of February 28, 1998, the Company was in default of the payment terms of the Plea Agreement and had made payments aggregating $350,000. On March 27, 1998, the Company and the DOJ signed the Letter Agreement serving to amend the Plea Agreement relating to the terms of the Company's satisfaction of the fine assessed under the Plea Agreement Specifically, the Letter Agreement provided that the Company will satisfy the remaining $2,150,000 of the fine through the payment of $25,000 on a monthly basis commencing June 1, 1998, plus interest on such outstanding balance (at the rate calculated pursuant to 28 U.S.C Section 1961)(currently 5.319%). Such payment schedule will result in the full satisfaction of the DOJ fine in December, 2005. The Letter Agreement also provides certain restrictions on the payment of salary or compensation to any individual in excess of $150,000 without the written consent of the United States District Court for the District of Maryland, subject to certain exceptions. In addition, the Letter Agreement requires the repayment of the outstanding fine to the extent of 25% of the Company's after-tax profit or the remaining balance owed and 25% of the net proceeds received by the Company on any sale of a capital asset for a sum in excess of $10,000. If, at any time, the Company does not make the payments required under the Letter Agreement in a timely fashion, the United States will be free to declare that the fine is delinquent and/or in default, and exercise all legal process to immediately collect the full amount of the fine, interest and applicable penalties.

By letter dated October 23, 1995, the Company was notified by the New York State Education Department (the "Department") that the Professional Conduct Officer of the Office of Professional Discipline had determined that there was sufficient evidence of professional misconduct on the Company's part to warrant a disciplinary proceeding pursuant to New York law. Upon contacting the Deputy Director of the Office of Professional Discipline, counsel for the Company was advised that the alleged misconduct related to the same activities that were the subject of the DOJ investigation, indictment and plea. The Company submitted a written response on November 16, 1995. The Company and the Department have agreed to the entry of a Consent Order concluding any disciplinary proceedings. The Company will pay $175,000 in fines over five years. In addition, the Company's registration as a manufacturer of drugs in New York State is revoked, but such revocation is stayed and the Company has been placed on probation for a maximum of five years. The Company has the right to apply for removal from probation after two years. At December 31, 1998, the Company is current in its payment obligations with a remaining obligation of $140,000.

The Company's Common Stock is listed on the American Stock Exchange (the "Exchange") under the symbol "HDG."

The Company does not meet certain of the Exchange's criteria for continued listing. Accordingly, there can be no assurance that the Company's common stock will remain listed on the Exchange or that the Exchange will not commence a review of the Company's continued listing eligibility. If the Common Stock should become delisted from the Exchange, trading, if any, in the Common Stock would continue on the OTC

F-21

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

Bulletin Board, an NASD-sponsored inter-dealer quotation system, or in what is commonly referred to as the "Pink Sheets." In such event, a shareholder may find it more difficult to dispose of, or to obtain accurate quotations as to the market value of the Common Stock.

Immediately prior to the completion of the Offering, the Company was in default under the consent order with the Department for failure to satisfy two of the monthly installments of the fine as provided in the consent order. Prior to the completion of the Offering, the Company advised the Department as to the existence of the default and that such deficiencies would be corrected upon the completion of the Offering. The Company has satisfied these outstanding amounts and is now current under the consent order with the Department. Based on discussions between representatives of the Department and the Company's outside counsel handling this matter, the Company has been advised that the revocation of the Company's registration as a manufacturer of drugs in the State of New York will remain stayed and that the Company continues to have the right to apply for removal from probation after two years from the effective date of the consent order.

Other Legal Proceedings

Beginning in 1992, actions were commenced against the Company and numerous other pharmaceutical manufacturers in the Pennsylvania Court of Common Pleas, Philadelphia Division, in connection with the alleged exposure to diethylstilbestrol ("DES"). The defense of all of such matters was assumed by the Company's insurance carrier, and a substantial number have been settled by the carrier. Currently, five actions remain pending with the Company as a defendant, and the insurance carrier is defending each action. Similar actions were brought in Ohio, and have been dismissed based on Ohio law. The Company and its legal counsel do not believe any of such actions will have a material impact on the Company's financial condition.

The Company has been named as a defendant in four additional actions, each of which has been referred to the Company's carrier and has been accepted for defense. The first action, Alonzo v. Halsey Drug Co., Inc. and K-Mart Corp., No. 64DOT-95111-CT-2736 (Indiana Superior Court, Porter County), was commenced on November 5, 1995 and involves a claim for unspecified damages relating to the alleged ingestion of "Doxycycline 100." At this early stage of the proceedings, the Company is unable to predict with any degree of certainty the likely outcome of these claims and whether they will have a material adverse effect on the Company's financial condition. The second action, Files v. Halsey Drug Co., Index No. 198787193 (New York Supreme Court, Suffolk County), commenced on September 16, 1993, seeking $10,000,000 in damages for wrongful death allegedly caused by the ingestion of Isoniazid. Halsey has been dismissed from this action on motion for summary judgment. The third and fourth actions, entitled Hunt v. Halsey Drug Co., Inc., and McCray v. Halsey Drug Co., Inc. (New York State Supreme Court, Kings County), were commenced on October 21, 1993, seeking the recovery of $8,000,000 for alleged personal injuries suffered by two Wells Fargo security guards who responded to an alarm and were shot, resulting in the death of one and the injury to the other. The Company's insurance carrier and the plaintiffs in these matters have agreed in principle to a settlement providing for the payment by the Company's insurance carrier of the sum of $600,000 to the estate of John McCray and the sum of $150,000 to Joseph Hunt in full and final settlement of all their respective claims against the Company.

The Company has been named as a defendant in a complaint filed with the United States District Court, Eastern District of New York, on June 30, 1998 (the "Complaint") by Quality Products and Services, L.L.C. The Complaint alleges the existence of a Joint Venture Agreement between the Plaintiff and the Company concerning the development, manufacture and marketing of a single product. The Complaint also alleges that the Company has breached the Agreement by failing to satisfy its respective obligations defined in the Agreement. The Complaint seeks monetary damages of approximately $20 million. The Company believes that the allegations contained in the Complaint are without basis in fact, and that it has meritorious defenses to each of the allegations. The Company has retained counsel and intends to vigorously defend this action. This matter is currently in discovery. The Company has filed a third-party complaint against Rosendo Ferran, the Company's former President, in connection with the Complaint.

F-22

HALSEY DRUG CO., INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)

The Company has been named as a defendant in an action in Suffolk County, New York, by Designed Laboratories, Inc., for construction work allegedly performed at the Company's facilities in Brooklyn. Plaintiff is seeking approximately $148,000. The Company has no records of work being performed by this entity, and is therefore defending the action.

The Company's former President, Rosendo Ferran, has instituted an arbitration against the Company, seeking sums alleged due under his employment contract in the amount of $225,000, deferred salary in the approximate amount of $100,000, and unspecified damages upon allegations of age, ethnic and religious discrimination. The Company believes it has meritorious defenses to the allegations claimed in the arbitration. The Company and its legal counsel do not believe this claim will have a material adverse effect on the Company's financial condition.

NOTE N -- SIGNIFICANT CUSTOMERS AND SUPPLIERS

The Company sells its products to a large number of customers who are primarily drug distributors, drugstore chains and wholesalers and are not concentrated in any specific region. The Company performs ongoing credit evaluations of its customers and generally does not require collateral. During 1998, the Company had net sales to one customer in excess of 10% of total sales, aggregating 11.5% of total sales. During 1997, the Company had net sales to two customers in excess of 10% of total sales. One customer (Mallinckrodt) accounted for 22.1% of total sales and another customer (Warner Chilcott) accounted for 10% of total sales. During 1996, the Company had net sales to one customer aggregating 10% of total sales.

During 1998 and 1997, the Company purchases approximated $2,583,000 and $1,187,000, respectively, representing approximately 29% and 25%, respectively, of total purchases for those years.

NOTE O -- SUBSEQUENT EVENTS

Lease of Congers, New York Facility

Effective March 22, 1999, the Company leased, as sole tenant, a pharmaceutical manufacturing facility located in Congers, New York (the "Congers Facility") from Par Pharmaecutical, Inc. ("Par") pursuant to an Agreement to Lease (the "Lease"). The Congers Facility contains office, warehouse and manufacturing space and is approximately 35,000 square feet. The Lease provides for a term of three years, with a two-year renewal option and provides for annual fixed rent of $500,000 per year during the primary term of the Lease and $600,000 per year during the option period. The Lease also covers certain manufacturing and related equipment previously used by Par in its operations at the Congers Facility (the "Leased Equipment"). In connection with the execution of the Lease, the Company and Par entered into a certain Option Agreement pursuant to which the Company may purchase the Congers Facility and the Lease Equipment at any time during the lease term for $5 million.

As part of the execution of the Lease, the Company and Par entered into a certain Manufacturing and Supply Agreement (the "M&S Agreement") having a term of two years. The M&S Agreement provides for the Company's contract manufacture of certain designated products manufactured by Par at the Congers Facility prior to the effective date of the Lease. The M&S Agreement also provides that Par will purchase a minimum of $1,150,000 in product during the initial 18 months of the Agreement. The M&S Agreement further provides that the Company will not manufacture, supply, develop or distribute the designated products to be supplied by the Company to Par under the M&S Agreement to or for any other person for a period of three years.

F-23

CONSENT OF INDEPENDENT CERTIFIED PUBLIC ACCOUNTANTS

We have issued our report dated March 5, 1999, accompanying the consolidated financial statements included in the Annual Report of Halsey Drug Co., Inc. on Form 10-K for the year ended December 31, 1998. We hereby consent to the incorporation by reference of said report in the Registration Statements of Halsey Drug Co., Inc. on Form S-8 (File No. 33-98396, effective October 19, 1995).

GRANT THORNTON LLP

New York, New York
March 5, 1999

F-24

EXHIBIT INDEX

Exhibit 3.1

Certificate of Incorporation and amendments

Exhibit 3.3

Restated By-Laws

Exhibit 10.45

[Amended, Restated and Consolidated Bridge Loan Agreement dated as of December 2, 1998 between the Company, Galen Partners III, L.P., Galen Partners International III, L.P., Galen Employee Fund III, L.P.


and the other signatures thereto]

Exhibit 10.46

[First Amendment to Amended, Restated and Consolidated Bridge Loan Agreement dated December 7, 1998 between the Company and the lenders listed on the signature page thereto]

Exhibit 10.47

[Second Amendment to Amended, Restated, Consolidated Bridge Loan Agreement dated March 8, 1999 between the Company and the lenders listed on the signature pages thereto]

Exhibit 10.48

[Form of 10% Convertible Secured Note due May 30, 1999]

Exhibit 10.49

[Form of Common Stock Purchase Warrant issued pursuant to the Amended, Restated and Consolidated Bridge Loan Agreement]

Exhibit 10.50

[Amended and Restated General Security Agreement dated December 2, 1998 between the Company and Galen Partners III, L.P., as Agent]

Exhibit 10.51

[Subordination Agreement dated December 2, 1998 between the Registrant and Galen Partners III, L.P., as Agent]


Exhibit 10.52

[Agency Letter Agreement dated December 2, 1998 by and among the lenders a party to the Amended, Restated and Consolidated Bridge Loan Agreement, as amended]

Exhibit 10.53

[Lease Agreement dated March 17, 1998 between the Registrant and Par Pharmaceuticals Inc.]

Exhibit 10.54

[Lease Agreement dated September 1, 1998 between the Registrant and Crinson Ridge Partners]

Exhibit 10.55

[Manufacturing and Supply Agreement dated March 17, 1999 between the Company and Par Pharmaceuticals Inc.]

Exhibit 10.56

[Halsey Drug Co., Inc. 1998 Stock Option Plan]

Exhibit 23.1

[Consent of Grant Thornton LLP, independent certified public accountants]

Exhibit 27

[Financial Data Schedule, which is submitted electronically to the Securities

and Exchange Commission for informational purposes only and not filed]


Exhibit 3.1

[Amendments to Certificate of Incorporation]

CERTIFICATE OF AMENDMENT

OF THE CERTIFICATE OF INCORPORATION

OF

HALSEY DRUG CO., INC.

UNDER SECTION 805 OF THE NEW YORK BUSINESS CORPORATION LAW

* * * * *

WE, THE UNDERSIGNED, Michael K. Reicher and Peter Clemens, being respectively the President and the Secretary of Halsey Drug Co., Inc., hereby certify:

1. The name of the corporation is Halsey Drug Co., Inc. The corporation was originally incorporated under the name of Halsey Drug Co. Inc.

2. The certificate of incorporation of said corporation was filed with the Department of State on the 10th day of April, 1935, amended on June 16, 1952, restated on February 23, 1962, amended on March 12, 1984, amended on February 7, 1986, amended on August 20, 1986, amended on May 24, 1989, and further amended on August 27, 1998.

3. (a) The certificate of incorporation is amended to increase the number of directors to not more than eight (8).

(b) To effect the foregoing, Article SIXTH relating to the number of directors is amended to read as follows:


SIXTH: The number of directors shall be not less than three (3) nor more than eight (8) none of whom need be stockholders of the Corporation.

4. The amendment was authorized in the following manner:

By a unanimous written consent of the Board of Directors followed by an affirmative vote of the holders of a majority of the outstanding shares of Common Stock of the corporation entitled to vote thereon.

IN WITNESS WHEREOF, we have signed this certificate on the 28 day of January, 1999 and we affirm the statements contained herein as true under penalties of perjury.

_/S/_________________________________
Michael K. Reicher
President and Chief Executive Officer




_/S/_________________________________
Peter Clemens
Secretary


CERTIFICATE OF AMENDMENT

OF THE CERTIFICATE OF INCORPORATION

OF

HALSEY DRUG CO., INC.

Please forward the filing receipt for this document to:

ST. JOHN & WAYNE, L.L.C.

Attn: John P. Reilly, Esq.
2 Penn Plaza East, 10th Floor
Newark, New Jersey 07105


CERTIFICATE OF AMENDMENT

OF THE CERTIFICATE OF INCORPORATION

OF

HALSEY DRUG CO., INC.

UNDER SECTION 805 OF THE NEW YORK BUSINESS CORPORATION LAW

* * * * *

WE, THE UNDERSIGNED, Michael K. Reicher and Peter Clemens, being respectively the President and the Secretary of Halsey Drug Co., Inc., hereby certify:

1. The name of the corporation is Halsey Drug Co., Inc. The corporation was originally incorporated under the name of Halsey Drug Co. Inc.

2. The certificate of incorporation of said corporation was filed with the Department of State on the 10th day of April, 1935, amended on June 16, 1952, restated on February 23, 1962, amended on March 12, 1984, amended on February 7, 1986, amended on August 20, 1986 and further amended on May 24, 1989.

3. (a) The certificate of incorporation is amended to increase the number of authorized shares of Common Stock available from 20,000,000 to 40,000,000 Shares.

(b) To effect the foregoing, Article THIRD relating to the amount of authorized capital stock of the Corporation is amended to read as follows:


THIRD: The amount of the authorized capital stock of the Corporation shall be Four Hundred Thousand ($400,000) Dollars consisting of 40,000,000 shares of Common Stock, each share having a par value of $.01 per share.

4. The amendment was authorized in the following manner:

By a unanimous written consent of the Board of Directors followed by an affirmative vote of the holders of a majority of the outstanding shares of Common Stock of the corporation entitled to vote thereon.

IN WITNESS WHEREOF, we have signed this certificate on the 21st day of July and we affirm the statements contained herein as true under penalties of perjury.

_/S/_________________________________
Michael K. Reicher
President and Chief Executive Officer




_/S/_________________________________
Peter Clemens
Secretary


CERTIFICATE OF AMENDMENT

OF THE CERTIFICATE OF INCORPORATION

OF

HALSEY DRUG CO., INC.

Please forward the filing receipt for this document to:

ST. JOHN & WAYNE, L.L.C.

Attn: B. Knochenmus
2 Penn Plaza East, 10th Floor

Newark, New Jersey 07105


Exhibit 3.3
[Amended and Restated Bylaws]

As Amended: April 24, 1998

RESTATED

BY-LAWS
of
HALSEY DRUG CO., INC.

ARTICLE I.

STOCKHOLDERS.

SECTION 1. Annual Meeting. The annual meeting of the stockholders shall be held at such time and place in the City and State of New York as the Board of Directors may from time to time designate on a day not later than one hundred fifty (150) days from the end of the Corporation's last fiscal year, each year for the purpose of electing directors and of transacting such other business as may properly come before the meeting. The directors shall be chosen by a plurality of the votes at such election.

SECTION 2. Special Meetings. Special meetings of the stockholders may be called by a majority of the members of the Board of Directors or the President and shall be called at any time by the President, any Vice President or the Secretary upon the written request of stockholders owning a majority of the outstanding shares of the Corporation entitled to vote at the meeting, and shall be hold at such time and place in the City and State of New York as may be fixed in the call and stated in the notice.

SECTION 3. Notice of Meetings. Notice of each meeting of stockholders shall be in writing and signed by the President or a Vice President or the Secretary or an Assistant Secretary. Such notice shall state the purpose or purposes for which the meeting is called and the time when and the place where it is to be held, and copy thereof shall be served, either personally or by mail, upon each stockholder of record entitled to vote at such meeting, and upon each stockholder of record who, by reason of any action proposed at such meeting, would be entitled to have his stock appraised if such action were taken, not less than ten nor more than forty days before the meeting. If mailed, it shall be directed to a stockholder at his address as it appears on the stockbook unless he shall have filed with the Secretary of the Corporation a written request that notices intended for him be mailed to some other address, in which case it shall be mailed to the address designated in such request.


A meeting of stockholders may be held without notice, and any action proper to be taken by the stockholders may be taken thereat, if at any time before or after such action be completed the requirements for notice be waived in writing by all the stockholders of record entitled to notice of such meeting or by their attorneys thereunto authorized.

SECTION 4. Qualification of Voters. Unless otherwise provided in a certificate filed pursuant to law, every stockholder of record of the Corporation shall be entitled at every meeting of the stockholders to one vote for every share of stock standing in his name on the books of the Corporation.

Shares of its own stock belonging to the Corporation at the time of the meeting or at the time a voting record therefor, as hereafter provided, is taken, shares retired before the meeting and no longer deemed to be issued and outstanding at the time of the meeting although outstanding at the time a voting record therefor is taken, and shares issued before the meeting but after a voting record therefor is taken, shall not be voted, directly or indirectly, and shall not be counted in determining a quorum or the number of shares necessary to constitute a quorum or to take any action contemplated, unless otherwise provided by law.

The books and papers containing the list of stockholders shall be produced at any meeting of the stockholders upon the request of any stockholder. If the right to vote at any such meeting shall be challenged, the inspectors of election, or other person presiding thereat, shall require such books to be produced as evidence of the right of the person challenged to vote at such meetings and all persons who may appear from such books to be stockholders of the Corporation entitled to vote may vote at such meeting in person or by proxy, subject to the provisions of the law.

SECTION 5. Determination of Stockholders of Record for Certain Purposes. The Board of Directors may prescribe a period not exceeding forty days prior to any meeting of the stockholders or prior to the last day on which the consent or dissent of stockholders may be effectively expressed for any purpose without a meeting, or prior to the payment of any dividend, or the making of any distribution, or the delivery of evidence of rights or evidences of interests arising out of any change, conversion or exchange of capital stock, during which no transfer of stock on the books of the corporation may be made. In lieu of prohibiting the transfer of stock as aforesaid, the Board of Directors may fix a day and hour, not more than forty days prior to any such meeting, or to any such last day for the expression of consent or dissent, or to any such dividend payment, distribution or delivery, as the time as of which stockholders entitled to notice of and to vote at such meeting, or to express such consent or dissent or to the receipt of such dividend payment, distribution or delivery, as the case may be, shall be determined, and all persons who were stockholders of record at such time and no others shall be entitled to notice of and to vote at such meeting, to express such consent or dissent, or to the receipt of such dividend payment, distribution or delivery, as the case may be.


SECTION 6. Quorum. The amount of stock which must be represented at a meeting of the stockholders to constitute a quorum, unless otherwise provided by law, shall be a majority of the shares of the Corporation which are entitled to be voted at such meeting, represented by holders of record entitled to vote thereat, present in person or by proxy.

If at any meeting of the stockholders the amount of stock so represented shall not constitute a quorum or shall be less than the amount required by statute to take the action then contemplated, the holders of a majority of the shares of stock so represented may adjourn the meeting from time to time during the period of not more than forty days thereafter, without notice other than announcement at the meeting, until the required amount of stock shall be represented at the meeting, when such action may be taken as was contemplated by the notice of the meeting.

SECTION 7. Proxies. Every stockholder of the Corporation entitled to vote at any meeting thereof may vote by proxy. Every proxy must be executed in writing by the stockholder or by his duly authorized attorney. No proxy shall be valid after the expiration of eleven months from the date of execution unless the stockholder executing it shall have specified therein its duration.

SECTION 8. Inspectors of Election. Two inspectors of election to serve at each election of directors by stockholders or in any other case in which inspectors may act shall be appointed by the chairman at the meeting. The inspectors so appointed, before entering upon the discharge of their duties, shall be sworn faithfully to execute the duties of inspectors at such meeting with strict impartiality, and according to the best of their ability, and the oath so taken shall be subscribed by them. Thereupon the inspectors shall take charge of the polls and after the balloting shall make a certificate of the result of the vote taken. No director or candidate for the office of director shall be appointed such inspector.

SECTION 9. Form of Stock Certificates. The stock of the Corporation shall be represented by certificates, in such forms as the Board of Directors may from time to time prescribe, signed by the President or a Vice President and the Secretary or an Assistant Secretary or the Treasurer or an Assistant Treasurer, and sealed with the seal of the Corporation. Such seal may be a facsimile, engraved or printed. Where any such certificate in signed by a transfer agent or transfer clerk, the signatures of any such President, Vice-President, Secretary, Assistant Secretary, Treasurer and Assistant Treasurer upon such certificate may be facsimiles, engraved or printed. In case any such officer who has signed or whose facsimile signature has been placed upon such certificate shall have ceased to be such before such certificate is issued, it may be issued by the Corporation with the same effect as if such officer had not ceased to be such at the date of its issue.

Every certificate of stock issued by the Corporation shall plainly state upon the face thereof the number, kind and class of shares, including series, if any, which it represents.

SECTION 10. Transfers of Stock. Shares of the stock of the Corporation shall be transferable on the books of the Corporation, by the holder thereof in person or by his attorney, upon surrender or cancellation of certificates for the same number of shares, with a written assignment of


the certificate or a power of attorney to sell, assign or transfer the same or the shares represented thereby, signed by the person appearing by the certificate to be the owner of the shares represented thereby, either indorsed thereon or attached thereto, with such proof of the authenticity of the signature as the Corporation or its agents may reasonably require. Such assignment or power of attorney may be either in blank or to a specified person, and shall have affixed thereto all stock transfer stamps required by law.

No share shall be transferable until all previous calls thereon shall have been fully paid in.

SECTION 11. Lost, Stolen or Destroyed Stock Certificates. No certificate for shares of stock of the Corporation shall be issued in place of any certificate alleged to have been lost, stolen or destroyed, except upon production of such evidence of the loss, theft or destruction, and upon such indemnification of the Corporation and its agents to such extent and in such manner as the Board of Directors may from time to time prescribe.

ARTICLE II.

BOARD OF DIRECTORS.

SECTION 1. Power of Board and Qualification of Directors. The business of the Corporation shall be managed by its Board of Directors, all of whom shall be of full age and need not be stockholders. Directors shall be elected at the annual meetings of the stockholders and each director shall be elected to serve for one year and until his successors shall be elected and shall qualify.

SECTION 2. Number. The number of directors of the Corporation shall be not less than three nor more than eleven as fixed from time to time within said limits by the Board of Directors.

SECTION 3. Meetings or the Board. The annual meeting of the Board of Directors shall be held in each year after the adjournment of the annual stockholders' meeting and on the same day. If a quorum of the directors are not present on the day appointed for the annual meeting, the meeting shall be adjourned to some convenient day. No notice need be given of the annual meeting of the Board.

Meetings of the Board of Directors shall be held at such place as may from time to time be specified in the call of any meeting.

Regular meetings of the Board of Directors shall be held at such times as may from time to time be fixed by resolution of the Board, and no notice need be given of regular meetings.

Special meetings of the Board may be called at any time by the President and shall be called by the President, any Vice President or the Secretary upon the written request of any two members of the Board, to be held not more than five days after receipt of the said request. Notice of special


meetings say be oral, telegraphic or written and shall be served on or sent or mailed to each director not less than forty-eight hours before such meeting.

A special meeting of the Board of Directors may be held without notice, and any action proper to be taken by the Board of Directors may be taken thereat, if every member of the Board of Directors is present or if at any time before or after such action be completed the requirement for notice be waived in writing by every director entitled to notice of such meeting.

SECTION 4. Quorum and Power of a Majority. A majority of the Board of Directors at a meeting duly assembled shall be necessary to constitute a quorum for the transaction of business and the act of a majority of the directors present at such meeting shall be the act of the Board of Directors.

SECTION 5. Resignations. Any director of the Corporation may resign at any time by giving written notice to the Board of Directors or to the President or to the Secretary of the Corporation. Such resignation shall take effect at the time specified therein; and unless otherwise Specified therein the acceptance of such resignation shall not be necessary to make it effective.

SECTION 6. Vacancies. Vacancies in the Board of Directors, whether caused by death, resignation, increase in the number of directors, or otherwise, may be filled by a vote of a majority of the directors in office at the time. However, in case the number of directors be increased by action of the stockholders, the additional directors may be elected by vote of the stockholders at the meeting at which the increase is effected.

SECTION 7. Compensation. Directors, as such, shall not receive any stated salary for their services, but by resolution of the Board of Directors a fixed sum and expenses of attendance, if any may be allowed for attendance at each meeting of the Board. However, this by-law shall not be construed to preclude any director from serving the Corporation in any other capacity and receiving compensation therefor. Members of the Executive Committee and of other committees may be allowed like compensation for attending committee meetings.

SECTION 8. Executive Committee. The Board of Directors may, by vote of a majority of the Board, designate an Executive Committee, to consist of the President and such other member or members of the Board of Directors as may be designated by the Board of Directors. The Executive Committee shall have and may exercise, so far as may be permitted by law, all the powers of the Board of Directors in the management of the business, affairs and property of the Corporation during the intervals between meetings of the Board of Directors and shall have power to authorize the seal of the Corporation to be affixed to all papers which may require it; but the Executive Committee shall not have power to fill vacancies in the Board of Directors or to change the membership of, or to fill vacancies in, the Executive Committee, or to make or amend the by-laws of the Corporation. The Board of Directors shall have the power at any time to fill vacancies in, to change the membership of, or to dissolve the Executive Committee. The Executive Committee may hold meetings and make rules for the conduct of its business and appoint such committees and assistants


as it shall from time to time deem necessary. A majority of the members of the Executive Committee shall constitute a quorum determine its action. All action of the Executive Committee shall be reported at the meeting or the Board of Directors next succeeding such action.

SECTION 9. Other Committees. The Board of Directors may in its discretion appoint other committees which shall have such powers and perform such duties as from time to time may be prescribed by the Board of Directors. A majority of the members of any such committee may determine its action and fix the time and place of its meetings, unless the Board shall otherwise provide. The Board of Directors shall have power at any time to change the membership of any such committee, to fill vacancies, and to discharge any such committee.

SECTION 10. Telephonic Meetings. Unless otherwise restricted by the Certificate of Incorporation or these By-Laws, members of the Board of Directors or any committee thereof may participate in a meeting of such Board or committee by means of a conference telephone or similar communications equipment allowing all persons participating in the meeting to hear each other at the same time, and participation in a meeting pursuant to such means shall constitute presence in person at such meeting.

ARTICLE III.

OFFICERS.

SECTION 1. Officers. The Board of Directors, as soon as may be after the annual election of directors, shall elect a President, one or more Vice Presidents, a Secretary and a Treasurer, and from time to time may appoint such other officers (including among others, an Executive Vice President, one or more Assistant Secretaries and one or more Assistant Treasurers), agents and employees as it may deem proper. More than one office may be hold by the same person. The President shall be chosen from among the directors but no other officer need be a director.

SECTION 2. Salaries of Officers. The salaries of all officers of the Corporation shall be fixed by the Board of Directors.

SECTION 3. Term of Office. The term of office for all officers shall be for one year and until their respective successors are chosen and qualified.

SECTION 4. Powers and Duties.

(a) The President

The President shall preside at all meetings of the directors and shall generally oversee the management of the business of the Corporation. He shall be the chief executive officer of the Corporation and shall have the management of the business of the Corporation. He shall preside at all meetings of stockholders. Except as the Board of Directors may otherwise direct and except as


otherwise expressly provided in these by-laws or by law, the President shall execute any action on behalf of the Corporation as may from time to time be taken by the Board of Directors.

(b) Vice Presidents

The Vice Presidents, in the order designated by the Board of Directors, during the absence or disability of the President, shall perform the duties and exercise the powers of the President, and shall perform such other duties as the Board of Directors shall prescribe.

(c) Secretary

The Secretary shall attend all sessions of the Board and all meetings of the stockholders and record all votes and the minutes of all proceedings in a book to be kept for that purpose. He shall give or cause to be given notice of all meetings of stockholders and special meetings of the Board of Directors and shall Perform such other duties as may be prescribed by the Board of Directors. He shall keep in safe custody the seal of the Corporation and affix it to any instrument when authorized by the Board of Directors.

(d) Treasurer

The Treasurer shall have the custody of the corporate funds and securities and shall keep full and accurate accounts of receipts and disbursements in books belonging to the Corporation and shall deposit all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors. He shall disburse the funds of the Corporation as may be ordered by the Board of Directors, taking proper vouchers for such disbursements, and shall render to the President and directors at the regular meetings of the Boards or whenever they may require it, an account of all his transactions as Treasurer and of the financial condition of the Corporation.

The Treasurer shall, if required by the Board of Directors, give the Corporation a bond in such sum or sums and with such surety or sureties as shall be satisfactory to tho Board of Directors, conditioned upon the faithful performance of his duties and for the restoration to the Corporation in case of his death, resignation, retirement or removal from office of all books, papers, vouchers, money and other property of whatever kind in his possession or under his control belonging to the Corporation.

SECTION 5. Books to be Kept. The officers shall keep at the office of the Corporation correct books of account of all its business and transactions, and a book to be known as the stockbook, containing the names, alphabetically arranged, of all persons who are stockholders of the Corporation, showing their places of residence, the number of shares of stock held by them respectively, the time when they respectively became the owners thereof, and the amount paid thereon.


SECTION 6. Checks, Notes, etc. All checks and drafts on the Corporation's bank accounts and all bills of exchange and promissory notes and all acceptances, obligations and other instruments for the payment of money, shall be signed by such officer or officers or agent or agents as shall be thereunto authorized from time to time by the Board of Director.

ARTICLE IV.

OTHER MATTERS.

SECTION 1. Corporate Seal. The corporate seal shall have inscribed thereon the name of the Corporation and such other appropriate legend as the Board of Directors may from time to time determine. In lieu of the corporate seal, when so authorized by the Board of Directors or a duly empowered committee thereof, a facsimile thereof may be affixed or reproduced.

SECTION 2. Fiscal Year. The fiscal year of the Corporation shall be determined by the Board of Directors.

SECTION 3. Amendments. The by-laws of the Corporation may be amended, added to or repealed at any meeting of the stockholders by the vote of the holders of record of a majority of the outstanding shares of the Corporation entitled to vote at the meeting, provided that notice of the proposed change shall have been given in the notice of the meeting. The by-laws may also be, amended or Added to or repealed at any meeting of the Board of Directors by the vote of a majority of all members of the Board, provided that notice of the proposed change shall have been given in the notice of the meeting. However, any by-laws hereafter duly adopted at a meeting of the stockholders shall control action of the directors except as therein otherwise provided.

SECTION 4. Reliance Upon Reports. Each Director, each officer and each member of any committee designated by the Board of Directors shall in the performance of his duties be fully protected in relying in good faith upon the books of account or reports made to the Corporation by any of its officials, or by an independent certified public accountant, or by an appraiser selected with reasonable care by the Board of Directors, or by such officer or by such committee, or in relying in good faith upon other records of the Corporation.

SECTION 5. Removals.

(a) The stockholders may, at any meeting called for the purpose, by vote of a majority of the capital stock issued and outstanding and entitled to vote thereon, remove any director from office. The Board of Directors may, at any meeting called for the purpose, by an affirmative vote of two-thirds of their entire number holding office at the time, and for good cause shown, remove any director from office.

(b) The-Board of Directors may, at any meeting called for the purpose, by a vote of a majority of their entire number holding office at the time, remove from office any officer or agent


of the Corporation or any member of any committee appointed by the Board of Directors or by any committee appointed by the Board of Directors or by any officer or agent of the Corporation.

SECTION 6. Indemnification . It is expressly provided that any and every person made a party to any action, suit, or proceeding by or in the right of the corporation to procure a judgment in its favor by reason of the fact that he, his testator or intestate, is or was a director or officer of this corporation or of any corporation which be served as such at the request of this corporation, may be indemnified by the corporation to the full extent permitted by law, against any and all reasonable expenses, including attorneys' fees, actually and necessarily incurred by him in connection with the defense of such action or in connection with any appeal therein, except in relation to matters as to which it shall be adjudged in such action, suit or proceeding that such officer or director has breached his duty to the corporation.

It is further expressly provided that any and every person made a party to any action, suit, or proceeding other than one by or in the right of the corporation to procure a judgment in its favor, whether civil or criminal, including an action by or in the right of any other corporation of any type or kind, domestic or foreign, which any director or officer of the corporation served in any capacity at the request of the corporation, by reason of the fact that he, his testator or interstate, was a director or officer of the corporation, or served such other corporation in any capacity, may be indemnified by the corporation, to the full extent permitted by law, against judgments, fines, amounts paid in settlement, and reasonable expenses, including attorneys' fees; actually and necessarily incurred as a result of such action, suit or proceeding, or any appeal therein, if such person acted in good faith for a purpose which he reasonably believed to be in the best interests of the corporation and, in criminal actions or proceedings, in addition, had no

reasonable cause to believe that his conduct was unlawful.


Exhibit 10.45

[Amended, Restated and Consolidated Bridge Loan Agreement dated as of December 2, 1998 between the Company, Galen Partners III, L.P., Galen Partners International III, L.P., Galen Employee Fund III, L.P. and the other signatures thereto]


AMENDED, RESTATED AND CONSOLIDATED

BRIDGE LOAN AGREEMENT

for

$8,500,000

among

HALSEY DRUG CO., INC., as Borrower,

and

GALEN PARTNERS III, L.P.
GALEN PARTNERS INTERNATIONAL III, L.P.
GALEN EMPLOYEE FUND III, L.P.
and OTHERS, as Lenders,
and

GALEN PARTNERS III, L.P., as Agent for Lenders

Dated as of December 2, 1998


Wolf, Block, Schorr and Solis-Cohen LLP 250 Park Avenue New York, New York 10177


                                TABLE of CONTENTS

SECTION 1.  DEFINITIONS, TERMS AND HEADINGS..................................2
      1.1.  General Definitions..............................................2
      1.2.  Accounting Terms and Determinations..............................9
      1.3.  Other Terms; Headings............................................9

SECTION 2.  TERMS OF THE CONSOLIDATED BRIDGE LOAN............................9
      2.1.  Commitment.......................................................9
      2.2.  Consolidated Bridge Loan.........................................9
      2.3.  Amended, Restated and Consolidated Notes........................10
            (a)   The Amount................................................10
            (b)   General Terms ............................................10
            (c)   Adjustment of Conversion Price............................10
            (d)   Payment...................................................10
            (e)   Interest..................................................10
            (f)   Prepayments of Notes......................................11
            (g)   Interest After Event of Default...........................11
            (h)   Exchange or Replacement...................................11
            (i)   Transfer..................................................12
      2.4.  Warrants........................................................12
      2.5.  Security; Subordination of the Existing Credit Facility.........12
      2.6.  Registration Rights.............................................12
      2.7.  Consent and Waiver..............................................12
      2.8.  Agency Agreement ...............................................13
      2.9.  Miscellaneous...................................................13

SECTION 3.  CONDITION PRECEDENT.............................................13
      3.1.  Conditions Precedent to Consolidated Bridge Loan................13
      3.2.  No Liens........................................................13
      3.3.  Representations and Warranties Correct..........................14
      3.4.  Legal Opinion of Counsel to Borrower............................14
      3.5.  Officer's Certificate...........................................14
      3.6.  Closing Fees....................................................14

SECTION 4.  REPRESENTATIONS AND WARRANTIES..................................14
      4.1.  Representations and Warranties of Borrower......................14
            (a)   Organization and Qualification............................14
            (b)   Authority; Consents and Filings...........................14
            (c)   Enforceability............................................15
            (d)   No Conflict...............................................15
            (e)   Government Regulation.....................................15


                                        i

            (f)   Indebtedness; Rights in Collateral........................15
            (g)   Locations of Offices, Records and Inventory...............16
            (h)   Inventory.................................................16
            (i)   No Judgments or Litigation................................16
            (j)   No Defaults...............................................16
            (k)   Financial Information, SEC Documents......................16
            (l)   Compliance with Law.......................................16
            (m)   Intellectual Property.....................................16
            (n)   Licenses and Permits......................................17
            (o)   Taxes.....................................................18
            (p)   Labor Disputes and Acts of God............................18
            (q)   Partnerships..............................................18
            (r)   Solvency..................................................18
            (s)   Forfeiture Proceeding.....................................18
            (t)   Offering..................................................18
            (u)   No Discrimination.........................................19
            (v)   ERISA.....................................................19
            (w)   Registration Rights.......................................19
            (x)   Accuracy and Completeness of Information..................19
      4.2.  Representations and Warranties of Lenders.......................19

SECTION 5.  CHANGE OF CONTROL PURCHASE ORDER;
            CONVERSION RIGHTS...............................................20
      5.1.  Change of Control...............................................20

SECTION 6.  AFFIRMATIVE COVENANTS...........................................22
            (a)   Financial Reporting and Projections.......................22
            (b)   Discharge Taxes and Indebtedness..........................22
            (c)   Notification Requirements.................................23
            (d)   Notice of Default.........................................23
            (e)   Proceedings or Adverse Changes............................23
            (f)   Corporate Existence, Charter and By-Laws; Corporate Name..23
            (g)   Books and Records; Inspections............................23
            (h)   Compliance with Laws; Compliance with Agreements..........23
            (i)   Use of Proceeds...........................................24
            (j)   Maintenance of Insurance..................................24
            (k)   Further Assurances........................................24
            (l)   Payment of Note...........................................24
            (m)   Reporting Requirements....................................24
            (n)   Authorization of Shares of Common Stock for Issuance
                  Upon Conversion of Note and Exercise of Warrants and
                  Voting Rights for Note Holders............................24


                                       ii

            (o)   Listing of Common Stock...................................25
            (p)   HSR Act Filing............................................25
            (q)   Year 2000 Computer Capability.............................25

SECTION 7.  NEGATIVE COVENANTS..............................................25
            (a)   Additional Indebtedness...................................25
            (b)   No Guarantee..............................................25
            (c)   Liens.....................................................26
            (d)   No Transfer of Asset......................................26
            (e)   Extraordinary Transactions and Disposal of Asset..........26
            (f)   Restricted Payments.......................................26
            (g)   Investments...............................................26
            (h)   Affiliate Transactions; Intercompany Transfers; Diversion
                  of Corporate Assets ......................................26
            (i)   Mergers...................................................27
            (j)   No Activities Leading to Forfeiture.......................27
            (k)   Corporate Documents; Fiscal Year..........................27
            (l)   Capital Expenditure.......................................27

SECTION 8.  REGISTRATION RIGHTS.............................................27
      8.1.  Restrictive Legend..............................................27
      8.2.  Certain Definitions.............................................28
      8.3.  Requested Registration..........................................28
      8.4.  Piggyback Registrations.........................................29
      8.5.  Holdback Agreements.............................................30
      8.6.  Registration Procedures.........................................31
      8.7.  Expenses of Registration........................................32
      8.8.  Indemnification.................................................32
      8.9.  Information by Holders..........................................34
      8.10. Limitations on Registration of Issues of Securities.............34
      8.11. Rule 144 Reporting..............................................34
      8.12. Participation in Underwritten Registrations.....................35
      8.13. Selection of Underwriters.......................................35
      8.14. Termination of Registration Rights..............................35

SECTION 9.  EVENTS OF DEFAULT AND REMEDIES..................................35
      9.1.  Events of Default...............................................35
      9.2.  Acceleration....................................................36
      9.3.  Remedies........................................................37
      9.4.  Application of Proceeds; Surplus; Deficiencies..................37

SECTION 10. GENERAL PROVISIONS..............................................37
      10.1. GOVERNING LAW...................................................37


                                       iii

      10.2.  SUBMISSION TO JURISDICTION.....................................37
      10.3.  SERVICE OF PROCESS.............................................38
      10.4.  JURY TRIAL.....................................................38
      10.5.  LIMITATION OF LIABILITY........................................38
      10.6.  Notices........................................................38
      10.7.  Indemnification................................................39
      10.8.  Amendments and Waivers.........................................40
      10.9   Construction...................................................40
      10.10. Counterparts and Effectiveness.................................41
      10.11. Severability...................................................41
      10.12. Entire Agreement; Successors and Assigns.......................41
      10.13. Assignments and Participations.................................41
      10.14. No Brokers.....................................................41
      10.15. No Novation....................................................42

Exhibits

      Exhibit A   List of Lenders, Their Contributions, Their Notes and Their
                  Warrants
      Exhibit B   Amended, Restated and Consolidated Notes
      Exhibit C   Warrants
      Exhibit D   Consent and Waiver
      Exhibit E   Agency Letter
      Exhibit F   Amended and Restated General Security Agreement
      Exhibit G   Subordination Agreement

iv

AMENDED, RESTATED AND CONSOLIDATED
BRIDGE LOAN AGREEMENT

THIS AMENDED, RESTATED AND CONSOLIDATED BRIDGE LOAN AGREEMENT is entered into as of December 2, 1998 among HALSEY DRUG CO., INC., a New York corporation ("Borrower"), GALEN PARTNERS III, L.P. ("Galen" or a "Lender"), GALEN PARTNERS
INTERNATIONAL III, L.P. and GALEN EMPLOYEE FUND III, L.P., each a Delaware limited partnership (each a "Lender", and collectively, with Galen, the "Galen Entities"), THOSE PERSONS WHOSE NAMES ARE SET FORTH ON THE SIGNATURE PAGE HERETO (each a "Lender", and collectively, with the Galen Entities, the "Lenders") and GALEN, as agent for the Lenders (in such capacity, the "Agent").

WHEREAS, Borrower and the Galen Entities entered into a Bridge Loan Agreement dated as of August 12, 1998 (as amended through the date hereof, the "Original Bridge Loan Agreement"), pursuant to which the Galen Entities made a loan to Borrower in the amount of $1,000,000 (the "Initial Bridge Loan"), as evidenced by a promissory note ("Bridge Note 1") in such amount;

WHEREAS, Borrower and the Galen Entities entered into a First Amendment to Bridge Loan Agreement dated as of September 17, 1998 (the "First Amendment"), pursuant to which the Galen Entities made a loan to Borrower in the amount of $500,000 (the "First Amendment Loan"), as evidenced by a promissory note ("Bridge Note 2") in such amount;

WHEREAS, Borrower and the Galen Entities entered into a Second Amendment to Bridge Loan Agreement dated as of October 2, 1998 (the "Second Amendment"), pursuant to which the Galen Entities made a loan to Borrower in the amount of $500,000 (the "Second Amendment Loan"), as evidenced by a promissory note ("Bridge Note 3") in such amount;

WHEREAS, Borrower, the Galen Entities and Michael Weisbrot and Susan Weisbrot (each, a "Lender" and collectively, the "Weisbrots") entered into a Third Amendment to Bridge Loan Agreement dated as of October 19, 1998 (the "Third Amendment"), pursuant to which the Galen Entities made a loan to Borrower in the amount of $150,000 (the "Third Amendment Galen Loan"), as evidenced by a promissory note ("Bridge Note 4") in such amount, and, pursuant to which the Weisbrots made a loan to Borrower in the amount of $100,000 (the "Third Amendment Weisbrot Loan", as evidenced by a promissory note ("Bridge Note 5") in such amount (the Third Amendment Galen Loan and the Third Amendment Weisbrot Loan, collectively the "Third Amendment Loan");

WHEREAS, Borrower and the Galen Entities entered into a Fourth Amendment to Bridge Loan Agreement dated as of October 29, 1998 (the "Fourth Amendment"), pursuant to which the Galen Entities made a loan to Borrower in the amount of $750,000 (the "Fourth Amendment Loan"), as evidenced by a promissory note ("Bridge Note 6") in such amount;

1

WHEREAS, Borrower and the Galen Entities entered into a Fifth Amendment to Bridge Loan Agreement dated as of November 6, 1998, pursuant to which the Galen Entities made a loan to Borrower in the amount of $1,500,000 (the "Fifth Amendment Loan"), as evidenced by a promissory note ("Bridge Note 7") in such amount (the Initial Bridge Loan, the First Amendment Loan, the Second Amendment Loan, the Third Amendment Loan, the Fourth Amendment Loan and the Fifth Amendment Loan, collectively, the "Original Bridge Loan" and Bridge Note 1, Bridge Note 2, Bridge Note 3, Bridge Note 4, Bridge Note 5, Bridge Note 6 and Bridge Note 7, collectively, the "Original Notes");

WHEREAS, Borrower has requested that some or all Lenders consider making an additional $3,250,000 bridge loan to Borrower ("Additional Bridge Loan");

WHEREAS, to induce such Lenders to extend to Borrower the Additional Bridge Loan, Borrower has agreed to execute this Amended, Restated and Consolidated Bridge Loan Agreement (the "Agreement");

WHEREAS, some or all of the Lenders, as signatories to a certain Debenture and Warrant Purchase Agreement dated as of March 10, 1998 (the "Debenture and Warrant Purchase Agreement") and as holders of certain 10% convertible subordinated debentures issued and dated August 6, 1996 (the "1996 Debentures") desire to participate in this Agreement by exercising certain first refusal or preemptive rights granted under Section 16.1 of the Debenture and Warrant Purchase Agreement and under Article 8A of the 1996 Debentures;

WHEREAS, Borrower and Lenders desire to amend and restate the Original Bridge Loan Agreement and consolidate the Original Bridge Loan with the Additional Bridge Loan, such that the terms of such Original Bridge Loan as set forth in the Original Bridge Loan Agreement, as so amended and restated, the terms of such Additional Bridge Loan and the terms of such consolidation, are set forth in this Agreement;

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the recipient and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

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SECTION 1. DEFINITIONS, TERMS AND HEADINGS

1.1. General Definitions.

Additional Bridge Loan has the meaning set forth in the Recitals to this Agreement.

Additional Bridge Loan Commitment means the commitment of each Lender to fund the dollar amount of its share of the Additional Bridge Loan in the amount set forth opposite such Lender's name on Exhibit A, copy of which is attached hereto and made a part hereof.

Affiliate of a Person means another Person who directly or indirectly controls, is controlled by, is under common control with or is a director or officer of, such Person. For purposes of this definition, "control" means the possession, directly or indirectly, of the power to vote five percent (5%) or more of the securities having ordinary voting power for the election of directors or the direct or indirect power to direct the management and policies of a business.

Agency Agreement means the Agency Agreement by and among the Agent and each Lender dated as of the date hereof and entered into simultaneously herewith, substantially in the form of Exhibit E attached hereto

Agreement means this Agreement, as the same may be amended, extended, modified, restated or supplemented from time to time.

Authorizations means all filings, recordings and registrations with, and all validations or exemptions, approvals, orders, authorizations, consents, licenses, certificates and permits from any Governmental Authority.

Bridge Loan Documents mean, collectively, this Agreement, the Notes, the Warrants, the Consent and Waiver, the Agency Agreement, each of the Collateral Documents and all other documents, agreements, instruments, opinions and certificates now or hereafter executed and delivered in connection herewith or therewith, as amended, extended, modified, restated or supplemented from time to time.

Business Day means any day other than a Saturday, Sunday or other day on which commercial banks in New York City are authorized or required by law to close.

Closing Date means the date upon which the last of the events, the fulfillment of each of which is condition precedent to the effectiveness of this Agreement, as set forth in Section 3 of this Agreement, shall have occurred.

Code has the meaning set forth in Section 1.3.

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Collateral means all property of Borrower, of whatever kind or nature whether now owned or hereafter acquired or created, wherever located, including, without limitation, all property identified as security for the Obligations under the Collateral Documents.

Collateral Documents means the General Security Agreement, the Subordination Agreement and all other contracts, instruments and other documents pursuant to which Liens are now or hereafter granted to Agent, for the benefit of Lenders, or to Lenders, to secure the Obligations, as any of such documents may be amended, extended, modified, restated or supplemented from time to time.

Common Stock means the common stock of Borrower, par value $.01 per share.

Consent and Waiver means the Consent and Waiver executed by Majority Holders simultaneously herewith as of the date hereof, substantially in the form of Exhibit D attached hereto.

Consolidated Bridge Loan has the meaning set forth in Section 2.2.

Conversion Shares has the meaning set forth in Section 2.3(b) of this Agreement.

Debenture and Warrant Purchase Agreement means the Debenture and Warrant Purchase Agreement by and among Borrower, the Galen Entities, the Weisbrots and others, dated as of March 10, 1998.

Default means an event, condition or default which, with the giving of notice, the passage of time, or, both, would be an Event of Default.

Equipment means all present and future machinery, equipment, tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest.

Event(s) of Default has the meaning set forth in Section 9.1.

Existing Credit Facility/ies means the 5% Convertible Senior Secured Debentures in the aggregate principal amount of $25,800,000 issued pursuant to the Debenture and Warrant Purchase Agreement.

Expenses means (i) all reasonable costs and expenses of Lenders, or Agent, on behalf of Lenders, incurred in connection with, arising under or relating to the Bridge Loan Documents and the transactions contemplated therein and (ii) all reasonable costs and expenses (including the reasonable fees and expenses of legal counsel and other professionals) paid or incurred by Lenders, or Agent, on behalf of Lenders, (a) during the continuance of an Event of Default, (b) in enforcing or defending its rights under or with respect to this Agreement, the other Bridge Loan Documents, the Collateral Documents or any other document or instrument now or hereafter

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executed and delivered in connection herewith, (c) in collecting the Consolidated Bridge Loan, (d) in foreclosing or otherwise collecting upon the Collateral or any part thereof and (e) in obtaining any legal, accounting or other advice in connection with any of the foregoing.

Forfeiture Proceeding means the commencement of any action or proceeding affecting Borrower before any court, Governmental Authority, commission, board, bureau, agency or instrumentality, domestic or foreign which may result in the seizure or forfeiture of any of its property which would cause a Material Adverse Effect upon the operations, business, properties or financial condition of Borrower or on the ability of Borrower to perform its obligations hereunder.

GAAP means generally accepted accounting principles in the United States as in effect from time to time.

General Security Agreement means the Amended and Restated General Security Agreement by and between Borrower and Agent dated the date hereof and executed simultaneously herewith, substantially in the form of Exhibit F attached hereto.

Governing Documents means certificates or articles of incorporation, by-laws and other organizational or governing documents.

Governmental Authority means any nation or government, any state or other political subdivision thereof and any entity exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government.

Indebtedness of a Person means (a) indebtedness for borrowed money or for the deferred purchase price of property or services (other than trade liabilities incurred in the ordinary course of business and payable in accordance with customary practices), whether on open account or evidenced by a note, bond, debenture or similar instrument, (b) obligations under capital leases, (c) reimbursement obligations for letters of credit, banker's acceptances or other credit accommodations, (d) any direct, indirect, contingent or non-contingent guaranty or obligation for the indebtedness of another Person, except endorsements in the ordinary course of business and (e) indebtedness secured by any Lien on that Person's property, even if that Person has not assumed such Indebtedness.

Investment means all expenditures made and all liabilities incurred (contingently or otherwise) for or in connection with the acquisition of stock or Indebtedness of, or for loans, advances, capital contributions or transfers of property to, or acquisition of substantially all the assets of, a Person. In determining the aggregate amount of Investments outstanding at any particular time, (i) the amount of any Investment represented by a guaranty shall be taken at not less than the principal amount of the obligations guaranteed and outstanding; (ii) there shall be deducted in respect of each such Investment any amount received as a return of capital (but only by repurchase, redemption, retirement, repayment, liquidating dividend or liquidating distribution); (iii) there shall not be deducted in respect of any Investment any amounts received as earnings on such Investment,

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whether as dividends, interest or otherwise; and (iv) there shall not be deducted from the aggregate amount of Investments any decrease in the market value thereof.

Lien means any lien, claim, charge, pledge, security interest, assignment, hypothecation, deed of trust, mortgage, capitalized lease, conditional sale, retention of title, or other preferential arrangement having substantially the same economic effect as any of the foregoing, whether voluntary or imposed by law.

Majority Holders has the meaning set forth in Section 6.1(p).

Material Adverse Effect means a material adverse effect on (i) the business, prospects, operations, results of operations, assets, liabilities or condition (financial or otherwise) of Borrower, (ii) the ability of Borrower to perform its obligations under the Bridge Loan Documents, (iii) the ability of Agent or Lenders to enforce the Obligations or realize upon the Collateral, or
(iv) the value of the Collateral or the amount which Lenders would be likely to receive (after giving consideration to delays in payment and costs of enforcement) in a liquidation of such Collateral.

Maturity Date means May 30, 1999.

1998 Debentures mean the 5% convertible senior secured debentures issued pursuant to the Debenture and Warrant Purchase Agreement.

1996 Debentures mean the 10% convertible subordinated debentures issued and dated August 6, 1996.

Notes has the meaning set forth in Section 2.3.

Obligations means the unpaid principal and interest hereunder, Expenses and all other obligations and liabilities of Borrower to Lenders under this Agreement, the Notes, or any other Bridge Loan Document and includes, but is not limited to, any and all indebtedness of Borrower to Lenders, whether now existing or hereafter incurred, of every kind and character, direct or indirect, and whether such indebtedness is from time to time reduced and thereafter increased, or entirely extinguished and thereafter reincurred, including, without limitation: (a) indebtedness not yet outstanding, but contracted for, or with respect to which any other commitment by Lenders exists; (b) all interest provided in any instrument, document, or agreement (including this Agreement) which accrues on any indebtedness until payment of such indebtedness in full; and (c) any moneys payable as hereinabove provided.

Permitted Investments mean (i) marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one (1) year from the date of acquisition thereof, (ii) commercial paper maturing no more than one (1) year from the date of creation thereof and currently having the highest rating

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obtainable from either Standard & Poor's Corporation or Moody's Investors Service, Inc., and (iii) certificates of deposit maturing no more than one (1) year from the date of investment therein issued by Bank.

Permitted Liens mean:

(a) Liens (i) upon or in any Equipment acquired or held by Borrower or any of its Subsidiaries to secure the purchase price of such Equipment or indebtedness incurred solely for the purpose of financing the acquisition of such Equipment, or (ii) existing on such Equipment at the time of its acquisition, provided that the Lien is confined solely to the property so acquired and improvements thereon, and the proceeds of such Equipment.

(b) Liens on Equipment leased by Borrower or any Subsidiary pursuant to an operating lease in the ordinary course of business (including proceeds thereof and accessions thereto) incurred solely for the purpose of financing the lease of such Equipment and Liens arising from UCC financing statements regarding leases permitted by this Agreement.

(c) Liens incurred in connection with the extension, renewal or refinancing of the indebtedness secured by Liens of the type described in clauses (a) through (b) above, provided that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced does not increase.

(d) Liens securing the obligation arising out of the Debenture and Warrant Purchase Agreement.

(e) Liens for taxes, assessments and other governmental charges, if payment thereof shall not at the time be required to be made, and provided such reserve as shall be required by GAAP consistently applied shall have been made therefor;

(f) Liens of workmen, materialmen, vendors, suppliers, mechanics, carriers, warehouseman and landlords or other like Liens, incurred in the ordinary course of business for sums not then due or being contested in good faith, if an adverse decision in which contest would not materially affect the business of Borrower;

(g) Liens securing indebtedness of Borrower or any Subsidiaries which (i) relates to a working capital line of credit in an amount not to exceed $10,000,000 or (ii) is in an aggregate principal amount not exceeding $500,000;

(h) Statutory Liens of landlords, statutory Liens of banks and rights of set-off, and other Liens imposed by law, in each case incurred in the ordinary course of business (i) for amounts not yet overdue or (ii) for amounts that are overdue and that are being contested in good

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faith by appropriate proceedings, so long as such reserves or other appropriate provisions, if any, as shall be required by GAAP shall have been made for any such contested amounts;

(i) Liens incurred or deposits made in the ordinary course of business in connection with workers' compensation, unemployment insurance and other types of social security, or to secure the performance of tenders, statutory obligations, surety and appeal bonds, bids, leases, government contracts, trade contracts, performance and return-of-money bonds and other similar obligations (exclusive of obligations for the payment of borrowed money);

(j) Any attachment or judgment Lien not constituting an Event of Default;

(k) Easements, rights-of-way, restrictions, encroachments, and other minor defects or irregularities in title, in each case which do not and will not interfere in any material respect with the ordinary conduct of the business of Borrower or any of its Subsidiaries;

(l) Any (i) Interest or title of a lessor or sublessor under any lease, (ii) Restriction or encumbrance that the interest or title of such lessor or sublessor may be subject to, or (iii) Subordination of the interest of the lessee or sublessee under such lease to any restriction or encumbrance referred to in the preceding clause (ii), So long as the holder of such restriction or encumbrance agrees to recognize the rights of such lessee or sublessee under such lease;

(m) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of customs duties in connection with the importation of goods;

(n) Any zoning or similar law or right reserved to or vested in any governmental office or agency to control or regulate the use of any real property;

(o) Liens securing obligations (other than obligations representing debt for borrowed money) under operating, reciprocal easement or similar agreements entered into in the ordinary course of business of Borrower and its Subsidiaries;

(p) The liens listed in the Permitted Lien Schedule of the Schedule of Exceptions; and

(q) The replacement, extension or renewal of any Lien permitted by under Section 10.4 of the Debenture and Warrant Purchase Agreement upon or in the same property theretofore subject or the replacement, extension or renewal (without increase in the amount or change in any direct or contingent obligor) of the indebtedness secured thereby.

Person means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, institution, entity, party or government (including any division, agency or department thereof), and its successors, heirs and assigns.

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Prime Rate means the rate of interest quoted in the "Money Rates" column of The Wall Street Journal as published in the City of New York from time to time as the then prevailing prime rate, provided, however, that if no such rate can be finally determined on any Business Day by reference to such column or newspaper then the Prime Rate in effect on such day shall mean the rate of interest then announced by Morgan Guaranty Trust Company as its "prime rate", "base rate" or "reference rate".

Requirement of Law means any law, treaty, rule or regulation or determination of an arbitrator, court or other Governmental Authority.

Solvent, when used with respect to any Person on a particular date, means that on such date: (a) the fair saleable value of its assets is in excess of the total amount of its liabilities, including, without limitation, the reasonably expected amount of such Person's obligations with respect to contingent liabilities, (b) the present fair saleable value of the assets of such Person is not less than the amount that will be required to pay the probable liability of such Person on its debts as they become absolute and matured, (c) such Person does not intend to, and does not believe that it will, incur debts or liabilities beyond such Person's ability to pay as such debts and liabilities mature and (d) such Person is not engaged in business or a transaction for which such Person's property would constitute an unreasonably small capital.

Subordination Agreement means the subordination agreement by and among the Borrower, the Agent and the agent acting on behalf of the purchasers under the Debenture and Warrant Purchase Agreement dated the date hereof and executed simultaneously herewith, substantially in the form of Exhibit G attached hereto.

Subsidiary means, with respect to any Person, any corporation, association or other business entity of which more than fifty percent (50%) of the total voting power of shares of stock (or equivalent ownership or controlling interest) entitled (without regard to the occurrence of any contingency) to vote in the election of directors, managers or trustees thereof is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other Subsidiaries of that Person or a combination thereof.

Total Commitment means the commitment of each Lender to fund the aggregate dollar amount of its share of the Consolidated Bridge Loan, in the amount set forth opposite such Lender's name on Exhibit A. For purposes of calculating such Total Commitment, the Total Commitment of the Weisbrots shall be treated as a single joint and several commitment.

Warrant Shares has the meaning set forth in Section 2.4 of this Agreement.

Warrants mean the warrants to purchase 689,722 shares, in the aggregate, of the Common Stock, dated the date hereof, substantially in the form of Exhibit C hereto.

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1.2. Accounting Terms and Determinations. Unless otherwise defined or specified herein, all accounting terms used in this Agreement shall be construed in accordance with GAAP, applied on a consistent basis. The Financial Statements required to be delivered hereunder from and after the Closing Date, and all financial records, shall be maintained in accordance with reasonable accounting standards and practices, consistently applied.

1.3. Other Terms; Headings. Terms used herein that are defined in the Uniform Commercial Code in effect in the State of New York (the "Code") shall have the meanings given in the Code. Each of the words "hereof," "herein," and "hereunder" refer to this Agreement as a whole. An Event of Default shall "continue" or be "continuing" until it shall have been cured or until Lenders shall have agreed in writing to waive such Event of Default. References to Sections, Articles, Annexes, Schedules, and Exhibits are internal references to this Agreement, and to its attachments, unless otherwise specified. The headings and the Table of Contents are for convenience only and shall not affect the meaning or construction of any provision of this Agreement.

SECTION 2.
TERMS OF THE CONSOLIDATED BRIDGE LOAN

2.1. Commitment. Subject to the terms and conditions of this Agreement:
(i) each Lender hereby agrees to amend and restate the Original Notes and the Original Bridge Loan Agreement; (ii) each Lender hereby agrees to fund the amount of its Additional Bridge Loan Commitment and (iii) each Lender hereby agrees to consolidate the Original Bridge Loan, together with all interest accrued thereon, with the Additional Bridge Loan.

2.2. Consolidated Bridge Loan. Borrower warrants, represents and confirms that, as of the Closing Date, (i) the aggregate outstanding principal balance of the Original Bridge Loan equals $4,500,000, (ii) the aggregate accrued interest on such principal balance equals $71,111 and (iii) the aggregate outstanding principal balance of the Additional Bridge Loan equals $3,250,000. Borrower and Lenders agree that effective on the Closing Date, upon the consolidation of the outstanding principal balances of the Original Bridge Loan and the Additional Bridge Loan, and the addition to principal of the accrued interest on the Original Bridge Loan, Lenders shall be deemed to have made a single loan to Borrower in the aggregate principal amount of $7,721,111 (the "Consolidated Bridge Loan").

2.3 Amended, Restated and Consolidated Notes.

(a) The Amount. The Consolidated Bridge Loan is evidenced by Amended, Restated and Consolidated Notes payable by Borrower to the order of each Lender, each such Note in the form of Exhibit B attached hereto and each such Note in the original principal amount equal to such Lender's Total Commitment (each a "Note" and collectively, "Notes").

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(b) General Terms. The Notes are 10% Convertible Senior Secured Notes due on May 30, 1999. Each Note is convertible, in whole or in part, from time to time, into a number of shares of Common Stock, initially at the rate of one share of Common Stock for each $1.3688 in principal amount of the Note to be converted. For purposes of this Agreement, the term "Conversion Shares" shall mean the shares of Common Stock which may be issued upon conversion of all or a portion of the principal amount of the Notes.

(c) Adjustment of Conversion Price. The price at which the Conversion Shares may be acquired upon conversion of the Notes is subject to adjustment as set forth in Section 3.7 of each Note.

(d) Payment. So long as a Lender shall be the holder of any Note, Borrower will make payments of principal and interest to such Lender no later than 11 a.m. Eastern Standard Time on the date when such payment is due. Payments shall be made by delivery to such Lender at such Lender's address, furnished to Borrower in accordance with this Agreement, of a certified or official bank check drawn upon or issued by a bank which is a member of the New York Clearinghouse for banks or by wire transfer to such Lender's (or such Lender's nominee's) account at any bank or trust company in the United States of America, or with respect to the payment of accrued interest on the Notes, shares of Common Stock, as provided in Section 2.3(e) below. Each Lender further agrees that, before a Note is assigned or transferred, such Lender will make or cause to be made a notation thereon of principal payments previously made thereof and of the date to which interest thereon has been paid and will notify Borrower of the name and address of the transferee of such Note.

(e) Interest.

(i) Payment of Interest. Borrower shall pay interest to Lenders on the aggregate unpaid principal amount of the Consolidated Bridge Loan at the fixed rate of ten percent (10%) per annum at Maturity Date, as further set forth in each Note. Interest shall be calculated on the basis of a year of 360 days for the actual number of days elapsed. Each Lender shall have the option of (i) having the accrued interest on the principal of such Lender's Note paid at the Maturity Date in immediately available funds, or, alternatively, having the accrued interest on the principal of such Lender's Note converted into shares of Common Stock, the conversion price to be based on the average closing price of the Common Stock for the twenty (20) days prior to the payment date of the interest payment or as reported by the American Stock Exchange. Interest on the Consolidated Bridge Loan shall be paid in arrears on the date of any prepayment (on the amount prepaid), and on the Maturity Date (whether by acceleration or otherwise).

(ii) Excessive Interest. Notwithstanding any provision contained in this Agreement or any other Bridge Loan Document to the contrary, Lenders shall not be entitled to receive, collect or apply, as interest on the Consolidated Bridge Loan under this Agreement, any amount in excess of the maximum rate of interest permitted to be charged by applicable law, and, if Lenders shall have received, collected or applied as interest any such excess, such amount which

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would be excessive interest shall be applied first to the reduction of principal then outstanding, and second, if such principal amount is paid in full, any remaining excess shall forthwith be returned to Borrower.

(f) Prepayments of Notes. Borrower may not, without having received the prior written consent of the Majority Holders ("Majority Approval") prepay any Note, in whole or in part. Upon receipt of Majority Approval, Borrower may, upon at least three (3) Business Days' prior written notice to the Lenders, prepay the Notes, in whole or in part, with accrued interest to the date of such prepayment on the amount prepaid, provided that each such partial prepayment shall be in a principal amount of not less than $100,000. Prepayment of all or any portion of the Notes shall not entitle the Borrower to reborrow the amount so prepaid.

(g) Interest After Event of Default. From the date of occurrence of an Event of Default until the earlier to occur of the date upon which (i) all Obligations shall have been paid and satisfied in full or (ii) such Event of Default shall have been waived, interest on the Consolidated Bridge Loan shall be payable on demand at a rate per annum equal to the Prime Rate plus five and three-quarter percent (5-3/4%).

(h) Exchange or Replacement.

(i) Notice of Exchange or Replacement. Subject to Sections 2.3
(d); 2.3(g)(ii)and 10.13 below, at any time at the request of any holder of one or more of the Notes to Borrower at its office provided under Section 10.6 (the Notice Provision), Borrower, at its expense (except for any transfer tax or any other tax arising out of the exchange) will issue in exchange therefor new Notes, in such denomination or denominations ($100,000 or any larger multiple of $100,000, plus one Note in a lesser denomination, if required) as such holder may request, in the aggregate principal amount equal to the unpaid principal amount of the Note or Notes surrendered and substantially in the form thereof, dated as of the date to which interest has been paid on the Note or Notes surrendered (or, if no interest has yet been so paid thereon, then dated the date of the Note or Notes so surrendered) and payable to such person or persons or order as may be designated by such holder.

(ii) Actual Exchange or Replacement. Upon receipt of evidence satisfactory to Borrower of the loss, theft, destruction or mutilation of any Note and, in the case of any such loss, theft, or destruction, upon delivery of a bond of indemnity satisfactory to Borrower (provided that if the holder is a Lender or a financial institution, its own agreement will be satisfactory), or in the case of any such mutilation, upon surrender and cancellation of such Note, Borrower will issue a new Note of like tenor as if the lost, stolen, destroyed or mutilated Note were then surrendered for exchange in lieu of such lost, stolen, destroyed or mutilated Note.

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(i) Transfer.

(i) Notification of Proposed Sale. Subject to Sections 2.3
(h)(ii) and 10.13 below, each holder of a Note, by acceptance thereof, agrees that it will give Borrower ten (10) days written notice prior to selling or otherwise disposing of such Note. No such sale or other disposition shall be made unless:

(a) the holder shall have supplied to Borrower an opinion of counsel to the holder, reasonably acceptable to Borrower, to the effect that no registration under the Securities Act of 1933, as amended (the "Securities Act") is required with respect to such sale or other disposition, or

(b) an appropriate registration statement with respect to such sale or other disposition shall have been filed by Borrower and declared effective by the Securities and Exchange Commission (the "Commission").

(ii) Transfer without Notification. If the holder of a Note has obtained an opinion of counsel reasonably acceptable to Borrower to the effect that the sale of its Note may be made without registration under the Securities Act pursuant to compliance with Rule 144 (or any successor rule under the Securities Act), the holder need not provide Borrower with the notice required in Section 2.3 (h)(i) above.

2.4 Warrants. Subject to the terms of this Agreement and the terms of the Warrants substantially in the form of Exhibit C, Borrower will issue Warrants to purchase in the aggregate, 689,722 shares of the Common Stock, initially, at a price per share equal to the average closing price of a share of the Common Stock for the twenty (20) trading days immediately preceding the Closing Date, as reported the price of each share is reported by the American Stock Exchange. The Warrants shall be issued to each of Lenders in the amounts set forth opposite their names on Exhibit A. For purposes of this Agreement, the term "Warrant Shares" shall mean the shares of Common Stock that may be issued from time to time pursuant to the exercise of the Warrants.

2.5 Security; Subordination of the Existing Credit Facility. All of the Obligations of Borrower under this Agreement will be secured by the General Security Agreement, substantially in the form of Exhibit F. The indebtedness and Liens granted by Borrower pursuant to the Debenture and Warrant Purchase Agreement are subordinate to the indebtedness and Liens granted by Borrower pursuant to this Agreement, in accordance with the terms of the Subordination Agreement, substantially in the form of Exhibit G.

2.6 Registration Rights. The Conversion Shares and the Warrant Shares are entitled to the registrations rights set forth in Section 8 of this Agreement.

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2.7 Consent and Waiver. The lien, indebtedness and registration right restrictions and limitations have been waived by the holders of the 1998 Debentures pursuant to the Consent and Waiver, substantially in the form of Exhibit D.

2.8 Agency Agreement. In connection with the acts contemplated under this Agreement, the Bridge Loan Documents, the Collateral Documents or any other document relating hereto or thereto, the rights, powers, duties and obligations of Agent are set forth in the Agency Agreement, substantially in the form of Exhibit E.

2.9 Miscellaneous.

(a) Expenses. Borrower shall reimburse the Expenses of Lenders and Agent promptly upon demand. Payment of Expenses shall be made not later than 2:00 P.M. Eastern Standard Time on the day when due, in immediately available funds, to the offices of the Agent, at its offices located at the address set forth on Exhibit A, or as Agent may otherwise direct Borrower.

(b) Distribution and Application of Payments. Unless an Event of Default has occurred and is continuing, all payments received by Agent shall be applied against the Obligations in the following order: first, to the payment of any Expenses due and payable to Agent under any of the Bridge Loan Documents; second, to the ratable payment of any Expenses or Obligations due and payable to Lenders under any of the Bridge Loan Documents, other than those Obligations specifically referred to in the two clauses below; third, to the ratable payment of interest due on the Consolidated Bridge Loan; and, finally, to the ratable payment of principal due on the Consolidated Bridge Loan.

SECTION 3 CONDITIONS PRECEDENT

3.1. Conditions Precedent to Consolidated Bridge Loan. The obligation of each Lender to fund its ratable portion of the Additional Bridge Loan is subject to the satisfaction or waiver of the following conditions precedent:

(a) Each Lender shall have received duly executed originals of:

(i) this Agreement;
(ii) its Note;
(iii) its Warrant;
(iv) the General Security Agreement;
(v) the Subordination Agreement;
(vi) the Agency Agreement; and
(vii) the Waiver and Consent;

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each conforming to the requirements hereof and executed as of the date of this Agreement by a duly authorized representative of Borrower, the Agent and each Lender, as the case may require.

3.2. No Liens. From the date of effectiveness of the Fifth Amendment to the Closing Date of this Agreement, no Liens shall have arisen or been recorded against the Collateral.

3.3. Representations and Warranties Correct. The representations and warranties in Section 4 hereof shall be true and correct in all material respects when made, and shall be true and correct in all material respects on the Closing Date with the same force and effect as if they had been made on and as of the Closing Date.

3.4. Legal Opinion of Counsel to Borrower. Agent and Lenders shall have received an opinion of St. John & Wayne, L.L.C., counsel to Borrower, which opinion shall be dated as of the Closing Date and shall be reasonably satisfactory to Agent and Lenders and their respective counsel.

3.5. Officer's Certificate. Agent shall have received an Officer's Certificate of Borrower dated as of the Closing Date, certifying as to the (i) Borrower's Certificate of Incorporation and all amendments thereto, (ii) accuracy and completeness of all By-Laws attached thereto, (iii) updated Certificates of Good Standing with respect to the Borrower from the Secretaries of State of New York and Illinois, (iv) resolutions of the Borrower's Board of Directors approving the transactions relating to this Agreement and (v) incumbency and signature of the Borrower's duly authorized officers signing this Agreement and each of the Bridge Loan Documents to which it or they are a party and any other certificate or other document to be delivered pursuant thereto, together with evidence of the incumbency of such officer signing the same.

3.6. Closing Fees. All Expenses outstanding as of the date of this Agreement, including legal fees, relating to this Agreement and any and all documents relating thereto shall have been paid on or prior to the Closing Date.

SECTION 4 REPRESENTATIONS AND WARRANTIES

4.1. Representations and Warranties of Borrower. To induce Lenders to enter into this Agreement and make the Additional Bridge Loan, Borrower hereby represents and warrants to Lenders that the representations and warranties contained in this Section 4 are true, correct and complete. Such representations and warranties, and all other representations and warranties made by Borrower in any other Bridge Loan Documents, shall survive the execution and delivery of this Agreement and such other Bridge Loan Documents.

(a) Organization and Qualification. Borrower (i) is a corporation duly organized, validly existing and in good standing under the laws of the state of its incorporation,

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(ii) has the power and authority to own its properties and assets and to transact the businesses in which it presently is, or proposes to be, engaged and
(iii) is duly qualified and is authorized to do business and is in good standing in each jurisdiction where it presently is, or proposes to be, engaged in business, except where the failure to so qualify would not have a Material Adverse Effect.

(b) Authority; Consents and Filings. Borrower has the requisite corporate power and authority to execute and deliver each of the Bridge Loan Documents. Subject to: (a) compliance with the terms of the right of first refusal provided (i) in Section 16.1 of the Debenture and Warrant Purchase Agreement and (ii) in Article 8A of the 10% convertible subordinated debentures issued and dated August 6, 1996 and (b) the receipt of shareholder approval (i) to amend Borrower's certificate of incorporation to increase its authorized shares of Common Stock and (ii) to the extent required under Section 713 of the American Company Stock Exchange Guide, to authorize the issuance of the Conversion Shares and the Warrant Shares in the event a dilution adjustment to the Warrants results in an issuances of the Conversion Shares or the Warrant Shares at less than fair market value, no consent, authorization, permit or filing is required in connection with the execution, delivery and performance of this Agreement or any Bridge Loan Document, or the continuing operations of Borrower, except (i) those that have been obtained or made and (ii) filings necessary to create, perfect or retain the perfection of Liens against the Collateral. Except as otherwise set forth in this Section, all corporate action necessary for the execution, delivery and performance of any of the Bridge Loan Documents has been taken, provided however, that the listing of the Conversion Shares and the Warrant Shares on the American Stock Exchange is subject to the consent of the American Stock Exchange.

(c) Enforceability. This Agreement and each Bridge Loan Document is the legal, valid and binding obligation of Borrower, enforceable in accordance with its terms, except as such enforceability may be limited by (i) bankruptcy, insolvency or similar laws affecting creditors' rights generally, and (ii) general principles of equity.

(d) No Conflict. The execution, delivery and performance of each Bridge Loan Document by Borrower is not in contravention of (i) the Governing Documents of Borrower, or (ii) any Requirement of Law, or (iii) any franchise, license, permit, indenture, contract, lease, agreement (other than the loan agreements or security agreements executed in connection with the Existing Credit Facilities), instrument or other commitment to which it is a party or by which it or any of its properties are bound and will not, except as contemplated herein, result in the such imposition of any Liens upon any of its properties. No order, consent, approval, license, authorization, or validation of, or filing, recording or registration with, or completion by, any Governmental Authority, or any subdivision thereof, is required to authorize, or is required in connection with the execution, delivery and performance of, or the legality, validity, binding effect or enforceability of, this Agreement or any of the other Bridge Loan Documents.

(e) Government Regulation. Borrower is not subject to regulation under the Public Utility Holding Company Act of 1935, the Federal Power Act, the Interstate Commerce Act, the Investment Company Act of 1940, or any other Requirement of Law, other than the

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Bankruptcy Code, that limits its ability to incur indebtedness or its ability to consummate the transactions contemplated in this Agreement and the other Bridge Loan Documents.

(f) Indebtedness; Rights in Collateral. Borrower is not obligated or liable with respect to any Indebtedness, other than Indebtedness described on Borrower's Form 10-Q for the quarter ended September 30, 1998. All Collateral is owned or leased by Borrower, free and clear of any and all Liens in favor of third parties, other than the Permitted Liens, those Liens permitted in the Existing Credit Facilities and the Lien in favor of Lenders. Upon the proper filing of the UCC financing statements executed by Borrower in favor of the Agent, the security interests granted pursuant to the Bridge Loan Documents constitute valid and enforceable and perfected Liens on the Collateral, to the extent such Liens can be perfected by the filing of such financing statements.

(g) Locations of Offices, Records and Inventory. The address of the principal place of business and chief executive office of Borrower is set forth on Borrower's Form 10-Q for the quarter ended September 30, 1998. The books and records of Borrower, and all its chattel paper and records of Accounts, are maintained exclusively at such locations. There is no jurisdiction in which Borrower has any Collateral (except for vehicles and Inventory in transit for processing) other than those jurisdictions identified on Borrower's Form 10-Q for the quarter ended September 30, 1998.

(h) Inventory. All inventory of Borrower consists of a quality and quantity usable and salable in the ordinary course of business, except for obsolete items and items of below-standard quality, all of which have been or will be written off or written down to net realizable value on the unaudited consolidated balance sheet of Borrower and its Subsidiaries as of September 30, 1998. The quantities of each type of inventory (whether raw materials, work-in-process, or finished goods) are not excessive, but are reasonable and warranted in the present circumstances of Borrower.

(i) No Judgments or Litigation. No judgments, orders, writs or decrees are outstanding against Borrower nor is there now pending or, to the best of Borrower's knowledge after diligent inquiry, threatened, any litigation, contested claim, investigation, arbitration, or governmental proceeding by or against Borrower, other than those which, either singly or in the aggregate, would not have a Material Adverse Effect other than those identified on Borrower's Form 10-Q for the quarter ended September 30, 1998 and at its Brooklyn facility located at 1827 Pacific Street, Brooklyn, New York 11233.

(j) No Defaults. Borrower is not in default in any material respect under any term of any indenture, contract, lease, agreement, instrument or other commitment to which it is a party or by which it is bound. Except as otherwise described on Borrower's Form 10-Q for the quarter ended September 30, 1998, Borrower knows of no dispute regarding any such indenture, contract, lease, agreement, instrument or other commitment.

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(k) Financial Information, SEC Documents. None of the documents filed by Borrower with the Commission since December 31, 1995 contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements contained therein not false or misleading in light of the circumstances in which they were made. There is no fact known to Borrower which Borrower has not disclosed to Lenders prior to or as of the date of this Agreement which materially and adversely affects, or in the future is likely to materially and adversely affect, the business, properties, condition (financial or otherwise) or business prospects of Borrower and its Subsidiaries, taken as a whole.

(l) Compliance with Law. Borrower has not violated or failed to comply in any material respect with any Requirement of Law, including without limitation (a) applicable rules and regulations of any Governmental Authority having jurisdiction over its activities, (b) environmental laws, the consequence of which violation or failure has or is reasonably likely to have a Material Adverse Effect.

(m) Intellectual Property. Borrower possesses such assets, licenses, patents, patent applications, copyrights, service marks, trademarks, trade names, New Drug Applications, Investigatory New Drug Applications, Abbreviated New Drug Applications, Alternative New Drug Applications, registrations and quotas as issued by the Drug Enforcement Agency or the Attorney General of the United States pursuant to the Controlled Substances Act, as are necessary or advisable to continue to conduct its present and proposed business activities.

(n) Licenses and Permits

(i) Generally. Borrower and its Subsidiaries possesses such franchises, licenses, permits and other authority as are necessary for the conduct of its business as now being conducted and proposed to be conducted (except where the failure to possess such franchises, licenses, permits or other authority would not have a Material Adverse Effect on Borrower and its Subsidiaries taken as a whole) and Borrower and its Subsidiaries are not in default under any of such franchises, licenses, permits or other authority. Other than the approval required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"); other than as set forth in Schedule 4.10 of the Schedule of Exceptions or [Selected Reports] to the Debenture and Warrant Purchase Agreement; and other than those consents that have been obtained; no approval, consent, authorization or other order of, and no designation, filing, registration, qualification or recording with, any governmental authority or any other person or entity is required in connection with Borrower's valid execution, delivery and performance of this Agreement or the offer, issuance and sale of the Notes, Warrants, the Conversion Shares or the Warrant Shares by Borrower to Lenders or the consummation of any other transaction contemplated on the part of Borrower hereby.

(ii) The FDC, FDA, DEA and Controlled Substances Act, etc. Without limiting the generality of the representations and warranties made in
Section 4.1(n)(i) above, Borrower represents and warrants that (1) it and its Subsidiaries are in compliance in all material

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respects with all applicable provisions of the Federal Food, Drug, and Cosmetic Act (the "FDC Act"), (2) its products and those of its Subsidiaries are not adulterated or misbranded and are in lawful distribution, and (3) it and its Subsidiaries are in compliance with the following specific requirements:
Borrower and its Subsidiaries have registered all facilities with the United States Food and Drug Administration (the "FDA"); Borrower and its Subsidiaries have listed all drug products with the FDA; each drug product marketed by Borrower or any Subsidiary is the subject of an application approved by the FDA; all marketed drug products comply with any conditions of approval and the terms of the application submitted to the FDA; all drug products are manufactured in compliance with the FDA's good manufacturing practice regulations; all products are labeled and promoted in accordance with the terms of the marketing application and the provisions of the FDC Act; all adverse events that were required to be reported to the FDA have been reported to the FDA in a timely manner; each of Borrower and its Subsidiaries is in compliance in all material respects with the terms of the consent agreement entered into by Borrower with the United States Attorney for the Eastern District of New York on behalf of the FDA on June 29, 1993, as modified by the Joint Motion for Modification of Sentence dated May 8, 1998; to Borrower's knowledge, neither Borrower nor any Subsidiary is employing or utilizing the services of any individual who has been debarred under the FDC Act; all stability studies required to be performed for products distributed by Borrower or a Subsidiary have been completed or are ongoing in accordance with the applicable FDA requirements; any products exported by Borrower or a Subsidiary have been exported in compliance with the FDC Act; and each of Borrower and its Subsidiaries is in compliance in all material respects with the provisions of the Prescription Drug Marketing Act, to the extent applicable. Without limiting the generality of the representations and warranties made in Section 4(q)(i), Borrower also represents and warrants that it and its Subsidiaries are in compliance in all material respects with all applicable provisions of the Controlled Substances Act (the "CSA") and that Borrower and its Subsidiaries are in compliance with the following specific requirements: Borrower and its Subsidiaries are registered with the Drug Enforcement Administration (the "DEA") at each facility where controlled substances are exported, imported, manufactured or distributed; all controlled substances are stored and handled pursuant to DEA security requirements; all records and inventories of receipt and distributions of controlled substances are maintained in the manner and form as required by DEA regulations; all reports, including, but not limited to, ARCOS, manufacturing quotas, production quotas, and disposals, have been submitted to DEA in a timely manner; all adverse events, including thefts or significant losses of controlled substances, have been reported to DEA in a timely manner; to Borrower's knowledge, neither Borrower nor any Subsidiary is employing any individual, with access to controlled substances, who has previously been convicted of a felony involving controlled substances; and any imports or exports of controlled substances have been conducted in compliance with the CSA and DEA regulations.

(o) Taxes. Except as set forth on Schedule A to the General Security Agreement, Borrower has filed all tax returns (federal, state and local) required to be filed by it and Borrower has paid all taxes, assessments and governmental charges and levies thereon that are due, including interest and penalties, other than taxes, assessments and governmental charges and levies being contested in good faith by appropriate proceedings and with respect to which adequate

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reserves, in conformity with GAAP, consistently applied, shall have been provided on the books of Borrower.

(p) Labor Disputes and Acts of God. Neither the business nor the properties of Borrower are affected by any fire, explosion, accident, strike, lockout or other labor dispute, drought, storm, hail, earthquake, embargo, act of God or of the public enemy or other casualty (whether or not covered by insurance), materially and adversely affecting such business or properties or the operations of Borrower or the ability of Borrower to perform its obligations.

(q) Partnerships. Borrower is not a partner in any partnership.

(r) Solvency. Borrower is solvent.

(s) Forfeiture Proceeding. Borrower is not engaged in or does not propose to be engaged in the conduct of any business or activity which could result in a Forfeiture Proceeding and no Forfeiture Proceeding against Borrower is pending, or to the best knowledge of Borrower, threatened.

(t) Offering. Subject in part to the truth and accuracy of Lenders' representations and the compliance by Lenders with its covenants set forth in this Agreement and any subscription agreement executed and delivered by Lenders, the issuance of the Notes, the Warrants, the Conversion Shares and the Warrant Shares as contemplated by this Agreement are not subject to the registration requirements of the Securities Act, and, Borrower, or anyone acting on its behalf, will not take any action hereafter that would cause such registration requirements to be applicable.

(u) No Discrimination. Borrower does not in any manner or form discriminate, foster discrimination or permit discrimination against any person on the grounds of age, color, handicap, mental status, national origin, race, religion or sex.

(v) ERISA. Borrower has not received any notice indicating that it is not in compliance with any of the requirements of the Employee Retirement Income Security Act, as amended ("ERISA") and the regulations promulgated thereunder. With respect to the Borrower, there exists no event described in
Section 4043 of ERISA.

(w) Registration Rights. Except as provided for in this Agreement, the Debenture and Warrant Purchase Agreement, and as set forth in Schedule 4.14 of the Debenture and Warrant Purchase Agreement, the Borrower is not under any binding obligation to register any of its currently outstanding securities or any of its securities which may hereafter be issued.

(x) Accuracy and Completeness of Information. All factual information furnished by or on behalf of Borrower in writing to Lenders for purposes of or in connection with this Agreement or any Bridge Loan Documents, or any transaction contemplated hereby or thereby

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is or will be true and accurate in all material respects on the date as of which such information is dated or certified and not incomplete by omitting to state any material fact necessary to make such information not misleading at such time.

4.2. Representations and Warranties of Lenders. Each Lender represents and warrants that:

(a) Investment Intent. The Warrants and the Notes being acquired hereunder and the Conversion Shares and Warrant Shares that may be acquired upon conversion or of any of the Notes or Warrants, as the case may be, would be acquired for its own account and not with the view to, or the resale in connection with, any distribution or public offering thereof within the meaning of the Securities Act by reason of their issuance in a transaction exemption from the registration and prospectus delivery requirements of the Securities Act pursuant to Section 4(2) thereof, that they must be held indefinitely unless they are registered under the Securities Act or are exempt from registration and that the reliance of Borrower and others upon this exemption is predicated in part upon this representation and warranty.

(b) Acts and Proceedings. This Agreement has been duly authorized by all necessary action on the part of each Lender, has been executed and delivered by it and is a valid and binding agreement upon its part, enforceable in accordance with its terms, except as such enforceability may be limited by (i) bankruptcy, insolvency or similar laws affecting creditors' rights generally, and (ii) general principles of equity.

SECTION 5. CHANGE OF CONTROL
PURCHASE OFFER; CONVERSION RIGHTS

5.1. Change of Control.

(a) Upon the occurrence of a Change of Control (as hereinafter defined), Borrower shall make an offer to all holders of Notes to purchase (a "Change of Control Offer") all outstanding Notes and will purchase, on a day not more than thirty (30) days after the occurrence of the Change of Control (such purchase date being the "Change of Control Purchase Date"), all Notes properly tendered pursuant to such offer to purchase for a cash price (the "Change of Control Purchase Price") equal to 150% of the outstanding principal amount of the Notes, plus accrued and unpaid interest, if any, to the Change of Control Purchase Date.

(b) In order to effect a Change of Control Offer, Borrower shall, within ten (10) days after the occurrence of a Change of Control, in accordance with Section 10.6 (the Notice Provision), provide a Change of Control Offer to each Note holder. The Change of Control Offer shall remain open from the time of receipt thereof for at least fifteen (15) calendar days. The notice,

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which shall govern the terms of the Change of Control Offer, shall include such disclosures as are required by law and shall state:

(i) the date of such Change of Control and, briefly, the events causing such Change of Control;

(ii) that the Change of Control Offer is being made pursuant to this Section 5.1 and that all Notes properly tendered pursuant to the Change of Control Offer will be accepted for payment;

(iii) the Change of Control Purchase Price for each Note, the Change of Control Purchase Date, the date on which the Change of Control Offer expires, that if the holder desires to accept the Change of Control Offer, the Note held by such holder must be surrendered to Borrower or any designated paying agent of Borrower prior to 5:00 p.m. Eastern Standard Time on the Change of Control Purchase Date, and the name and address of any such paying agent, if any;

(iv) that any Note not tendered for payment will continue to accrue interest in accordance with the terms thereof;

(v) that, unless Borrower shall default in the payment of the Change of Control Purchase Price, any Note accepted for payment pursuant to the Change of Control Offer shall cease to accrue interest after the Change of Control Purchase Date;

(vi) that holders will be entitled to withdraw their acceptance of the Change of Control Offer election if Borrower or paying agent of Borrower receives, not later than 5:00 p.m. Eastern Standard Time on the day preceding the Change of Control Purchase Date a telex or facsimile transmission (confirmed by overnight delivery of the original thereof) or letter setting forth the name of the holder, the principal amount of Notes the holder delivered for purchase, and a statement that such holder is withdrawing its election to have such Notes purchased;

(vii) that holders whose Notes are purchased only in part will be issued Notes equal in principal amount to the unpurchased portion of the Notes surrendered; and

(viii) any other instructions that holders must follow in order to tender their Notes and the procedures for withdrawing an election to accept a Change of Control Offer.

(c) On the Change of Control Purchase Date, Borrower shall accept for payment Notes or portions thereof tendered pursuant to the Change of Control Offer and deposit with the paying agent, if any, money in United States dollars, in immediately available funds, sufficient to pay the Change of Control Purchase Price of all Notes or portions thereof so tendered and accepted. Borrower shall, or cause any paying agent to, promptly disburse or deliver to the holders of Notes so accepted payment in an amount equal to such Change of Control Purchase Price,

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and mail or deliver to such holders a new Note equal in principal amount to any unpurchased portion of each Note surrendered.

(d) Borrower shall comply, to the extent applicable, with the requirements of Section 14(e) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and any other securities laws or regulations, in connection with the repurchase of Notes pursuant to a Change of Control Offer. To the extent that the provision of any securities laws or regulations conflict with the provisions of this Section 5.1, Borrower shall comply with the applicable securities laws and regulations and shall not be deemed to have breached its obligations under this Section 5.1 by virtue thereof.

(e) For purposes of this Section:

(i) the term "Change of Control" means the occurrence of any of the following: the consummation of any transaction the result of which is that any person or group (as such term is used in Section 13(d)(3) of the Exchange Act), other than any of the Galen Entities, the Lenders or any Affiliate thereof or any group comprised of any of the foregoing, owns, directly or indirectly, 51% of the Common Equity (as hereinafter defined) of Borrower, Borrower consolidates with, or merges with or into, another person (other than a direct or indirect wholly-owned Subsidiary) or sells, assigns, conveys, transfers, leases or otherwise disposes of all or substantially all of Borrower's assets or the assets of Borrower and its Subsidiaries taken as a whole to any person, or any person consolidates with, or merges with or into, Borrower, in any such event pursuant to a transaction in which the outstanding Voting Stock (as hereinafter defined) of the Borrower, as the case may be, is converted into or changed for cash, securities or other property, other than any such transaction where the outstanding Voting Stock of Borrower, as the case may be, is converted into or exchanged for Voting Stock of the surviving or transferee corporation and the beneficial owners of the Voting Stock of Borrower immediately prior to such transaction own, directly or indirectly, not less than a majority of the Voting Stock of the surviving or transferee corporation immediately after such transaction, Borrower, either individually or in conjunction with one or more Subsidiaries sells, assigns, conveys, transfers, leases or otherwise disposes of, or the Subsidiaries sell, assign, convey, transfer, lease or otherwise dispose of, all or substantially all of the properties and assets of Borrower and its Subsidiaries, taken as a whole (either in one transaction or a series of related transactions), including capital stock of the Subsidiaries, to any person (other than Borrower or a wholly owned Subsidiary of Borrower), or during any two (2) year period commencing subsequent to the date of this Agreement, individuals who at the beginning of such period constituted the Board of Directors of Borrower (together with any new directors whose election by such Board of Directors or whose nomination for election by the stockholders of Borrower was approved by a vote of two-thirds of the directors then still in office) who were either directors at the beginning of such period or whose election or nomination for election was previously so approved cease for any reason to constitute a majority of the Board of Directors then in office; provided, however, that a person shall not be deemed to have ceased being a director for such purpose if such person shall have resigned or died or if the involuntary removal of such person was made at the direction the Galen Entities or of persons holding a majority in principal amount of the outstanding Notes;

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(ii) the term "Common Equity" of Borrower means all capital stock of Borrower that is generally entitled to vote on the election of members of the board of directors and (iii) the term "Voting Stock" of Borrower means securities of any class of capital stock of Borrower entitling the holders thereof to vote in the election of members of the board of directors of Borrower.

SECTION 6. AFFIRMATIVE COVENANTS

6.1. Until termination of this Agreement and payment and satisfaction of all Obligations due hereunder, Borrower agrees as follows:

(a) Financial Reporting and Projections. Borrower shall keep adequate records and books of account with respect to its business activities in which true, proper and accurate entries are made in accordance with reasonable accounting standards and practices, reflecting all its financial transactions. In addition, Borrower shall cause to be prepared and furnished to Lenders the financial information required to be delivered by it pursuant to the Debenture and Warrant Purchase Agreement and the documents ancillary thereto, at the times and in the manner set forth therein, provided, however, that in the event Borrower is no longer obligated to comply with such financial reporting requirements, then Borrower shall cause to be prepared and furnished to Lenders
(a) not later than (i) thirty (30) days after the end of each month after the Closing Date, (ii) forty-five (45) days after the end of each fiscal quarter after the Closing Date and (iii) 120 days after the end of each fiscal year after the Closing Date, unaudited Financial Statements as of the end of such month, quarter and year and of the portion of Borrower's fiscal year then elapsed, each certified by the chief financial officer of Borrower as prepared in accordance with GAAP, consistently applied and fairly presenting the financial position, results of operations and statement of cash flows of Borrower for such month, quarter and year, and (b) such other data and information (financial and otherwise) as Lenders, from time to time, may reasonably request, bearing upon or related to Borrower's financial condition or results of operations.

(b) Discharge Taxes and Indebtedness. The Borrower will pay and discharge, as they become due, all taxes, assessments, debts, claims and other governmental or non-governmental charges lawfully imposed upon or incurred by it or the properties and assets of the Borrower, except taxes, assessments, debts, claims and charges contested in good faith in appropriate proceedings for which the Borrower shall have set aside adequate reserves for the payment of such tax, assessment, debt, claim or charge. The Borrower shall provide each Lender, upon Lender's request, evidence of payment of such taxes, assessments, debts, claims and charges satisfactory to Lender.

(c) Notification Requirements. Borrower shall timely give Lenders the following notices:

(d) Notice of Defaults. Promptly, and in any event within two (2) Business Days after becoming aware of the occurrence of a Default or Event of Default, a certificate of the chief

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executive officer or chief financial officer of Borrower specifying the nature thereof and Borrower's proposed response thereto, each in reasonable detail.

(e) Proceedings or Adverse Changes. Promptly, and in any event within five (5) Business Days after Borrower becomes aware of (i) any proceeding being instituted or threatened to be instituted by or against Borrower in any federal, state, local or foreign court or before any commission or other regulatory body (federal, state, local or foreign) which, if adversely determined, could result in the entry of an order, judgment or decree against Borrower; (ii) any order, judgment or decree being entered against Borrower or any of its properties or assets or (iii) any actual or prospective change, development or event which has had or could reasonably be expected to have a Material Adverse Effect, a written statement describing such proceeding, order, judgment, decree, change, development or event and any action being taken with respect thereto by Borrower.

(f) Corporate Existence, Charter and By-Laws; Corporate Name. Borrower shall (i) maintain its corporate existence, (ii) maintain in full force and effect all licenses, bonds, franchises, leases, trademarks and qualifications to do business, and, all patents, New Drug Applications, Investigatory Drug Applications, Abbreviated New Drug Applications, Alter New Drug Applications, registrations and quotas as issued by the Drug Enforcement Agency or the Attorney General of the United States, pursuant to the Controlled Substances Act, contracts and other rights necessary or advisable to the profitable conduct of its business, and (iii) continue in, and limit its operations to, the same general lines of business as presently conducted by it.

(g) Books and Records; Inspections. Borrower agrees to maintain books and records pertaining to the Collateral in such detail, form and scope as is consistent with good business practice. Borrower agrees that Lenders or its agents may enter upon the premises of Borrower at any time and from time to time, during normal business hours and upon reasonable notice under the circumstances, and at any time at all on and after the occurrence of a Default which continues beyond the expiration of any grace or cure period applicable thereto, and which has not otherwise been waived by Lenders, for the purposes of
(i) inspecting and verifying the Collateral, (ii) inspecting and/or copying (at Borrower's expense) any and all records pertaining thereto, and (iii) discussing the affairs, finances and business of Borrower with any officers, managerial employees and directors of Borrower.

(h) Compliance with Laws; Compliance with Agreements. Borrower agrees to comply in all material respects with all Requirements of Law applicable to the Collateral or any part thereof, or to the operation of its business or its assets generally, unless Borrower contests any such Requirements of Law in a reasonable manner and in good faith. Borrower agrees to maintain in full force and effect its licenses and permits granted by any Governmental Authority as may be necessary or advisable for Borrower to conduct its business in all material respects. Borrower shall comply with the terms and conditions of all material agreements, commitments, or instruments to which Borrower is a party or by which it may be bound, including, without limitation, this Agreement and the Debenture and Warrant Purchase Agreement.

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(i) Use of Proceeds. Proceeds of the Consolidated Bridge Loan made hereunder shall be used by Borrower solely for its ongoing working capital requirements and other general corporate purposes. Borrower shall not use any portion of the proceeds of the Consolidated Bridge Loan for the purpose of purchasing or carrying any "margin stock" (as defined in Regulation U of the Board of Governors of the Federal Reserve System) in any manner which violates the provisions of Regulation T or X of said Board of Governors or for any other purpose in violation of any applicable statute or regulation, or of the terms and conditions of this Agreement.

(j) Maintenance of Insurance. Borrower shall maintain insurance with financially sound and reputable insurance companies or associations in such amounts and covering such risks as are usually carried by companies engaged in the same or a similar business and similarly situated. Borrower shall (i) deliver to Agent, upon its request, a detailed list of insurance then in effect, stating (A) the names of the insurance companies, (B) the amounts and rates of the insurance, (C) dates of expiration thereof and the properties and risks covered thereby; (ii) within fifteen (15) days after notice from Agent, obtain such additional insurance as Agent may reasonably request; and (iii) upon request, provide to Agent copies of all insurance policies. All such policies shall name Agent for Lenders as an additional insured and shall be part of the Collateral securing the Notes.

(k) Further Assurances. Borrower shall take all such further actions and execute all such further documents and instruments as Lenders may at any time reasonably determine in their sole discretion to be necessary or desirable to further carry out and consummate the transactions contemplated by the Consolidated Bridge Loan Documents and any documentation relating thereto, to cause the execution, delivery and performance of the Bridge Loan Documents to be duly authorized and to perfect or protect the Liens (and the priority status thereof) of Lenders on the Collateral.

(l) Payment of Notes. Borrower shall pay the principal of and interest on the Notes in the time, the manner and the form provided therein.

(m) Reporting Requirements. Borrower shall comply with its reporting and filing obligations pursuant to Section 13 or 15(d) of the Exchange Act. Borrower shall provide copies of such reports, including, without limitation, reports on Form 10-K, 10-Q, 8-K and Schedule 14A promulgated under the Exchange Act, or substantially the same information required to be contained in any successor form, to each Lender promptly upon filing with the Commission.

(n) Authorization of Shares of Common Stock for Issuance Upon Conversion of Note and Exercise of Warrants and Voting Rights for Note Holders. Borrower will present to its shareholders for consideration at the next annual meeting of Borrower's shareholders, to occur on or prior to May 30, 1999, a proposal to amend Borrower's Certificate of Incorporation to increase the number of authorized shares of Borrower's common stock available for issuance from 40,000,000 to 75,000,000 shares in order to provide for a sufficient number of authorized shares to be available and reserved for issuance upon conversion of the Notes and exercise of the Warrants. Upon receipt of approval from Borrower's shareholders to increase Borrower's authorized shares from 40,000,000 to 75,000,000 shares, Borrower will at all times cause there to be reserved for

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issuance a sufficient number of Conversion Shares and Warrant Shares upon conversion of the Notes and exercise of the Warrants.

(o) Listing of Common Stock. As promptly as practicable after the filing of a Certificate of Amendment to Borrower's Certificate of Incorporation to increase its Shares of Common Stock in accordance with Section 6.1(o) above, Borrower shall file the appropriate applications for listing with the American Stock Exchange the Conversion Shares and Warrant Shares. Borrower shall use its best efforts and work diligently to accomplish such listings as promptly as practicable after the annual meeting of the stockholders of the Company to take place on or prior to May 30, 1999.

(p) HSR Act Filing. Borrower hereby agrees to file all the Pre-Merger Notifications and reports, if any, required to be filed by it under the HSR Act with forty-five (45) days after its receipt of a written request to do so by the holder or holders of at least a majority of the aggregate principal amount of the Notes, then outstanding ("Majority Holders"). Such request shall be made in accordance with Section 10.6 below.

(q) Year 2000 Computer Capability. Borrower shall take all action necessary to assure that at all times the computer-based systems utilized by Borrower and each of its Subsidiaries are able to effectively interpret, process and manipulate data, including dates before, on and after December 31, 1999. At Agent's request, Borrower shall provide to Agent assurance that is reasonably satisfactory to Agent that the computer-based systems utilized by Borrower and each of its Subsidiaries are able to recognize and perform without error functions involving dates before, on and after December 31, 1999.

SECTION 7. NEGATIVE COVENANTS

7.1. Until the termination of this Agreement and the payment and satisfaction in full of all Obligations due hereunder, neither the Borrower, nor any of its Subsidiaries, will, either directly or indirectly, do or permit to be done, absent the prior written consent of the Majority Holders, the following:

(a) Additional Indebtedness. Borrower shall not directly or indirectly incur, create, assume or suffer to exist any Indebtedness other than
(a) Indebtedness under the Bridge Loan Documents, (b) Indebtedness permitted under the Existing Credit Facility, but not any increase in the outstanding principal amount thereof and (c) Indebtedness relating to a working capital line of credit in an amount not to exceed $10,000,000.

(b) No Guarantees. Except for obligations owing to Lenders under this Agreement and owing under the Existing Credit Facilities, Borrower will not assume, endorse or become liable for or guarantee the obligations of any corporation, partnership, individual or other

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entity excluding the endorsement of negotiable instruments for deposit or collection in the ordinary course of business.

(c) Liens. Except for Permitted Liens, Borrower shall not directly or indirectly create, incur, assume, or suffer to exist any Lien on any of its property now owned or hereafter acquired except Liens granted to Lenders under the Bridge Loan Documents and Liens described or permitted under the Existing Credit Facility.

(d) No Transfer of Assets. Borrower will not (a) enter into any acquisition, merger, consolidation, reorganization, or recapitalization, or reclassify its capital stock, or liquidate, wind up, or dissolve itself (or suffer any liquidation or dissolution), (b) convey, sell, assign, lease, transfer, or otherwise dispose of, in one transaction or a series of transactions, all or any substantial part of the business, property, or assets, whether now owned or hereafter acquired, of Borrower, or (c) acquire by purchase or otherwise all or substantially all of the property, assets, stock, or other evidence of beneficial ownership of any person or entity, except where the purchase price for such acquisition is less than $10,000 and the aggregate purchase price for all acquisitions made within any period of twelve months is less than $25,000.

(e) Extraordinary Transactions and Disposal of Assets. Borrower will not enter into any transaction not in the ordinary and usual course of Borrower's business, including the sale, lease, or other disposition of, moving, relocation, or transfer, whether by sale or otherwise, of any of Borrower's properties or assets (other than sales of inventory to buyers in the ordinary course of Borrower's business as currently conducted).

(f) Restricted Payments. Borrower shall not directly or indirectly
(a) declare or pay any dividend (other than dividends payable solely in Common Stock) on, or make any payment on account of, or set apart assets for a sinking or other analogous fund for, the purchase, redemption, defeasance, retirement or other acquisition of, any shares of any class of capital stock of Borrower or any warrants, options or rights to purchase any such capital stock, whether now or hereafter outstanding, or make any other distribution in respect thereof, either directly or indirectly, whether in cash or property or in obligations of Borrower; or (b) make any optional payment or prepayment on or redemption (including, without limitation, by making payments to a sinking or analogous fund) or repurchase of any Indebtedness (other than Indebtedness pursuant to this Agreement and in accordance with this Agreement).

(g) Investments. Except for Permitted Investments, Borrower shall not directly or indirectly make any Investment in any Person, whether in cash, securities, or other property of any kind.

(h) Affiliate Transactions; Intercompany Transfers; Diversion of Corporate Assets. Borrower shall not directly or indirectly (a) Enter into any transaction with, including, without limitation, the purchase, sale or exchange of property or the rendering of any service to, any Subsidiary or Affiliate of Borrower, unless any such transaction is at arm's length, on fair and reasonable terms to Borrower, and on terms which are no more onerous to Borrower as

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could be obtained from a Person unrelated to Borrower; (b) Make any intercompany transfers of monies or other assets in any single transaction or series of transactions, except as otherwise permitted in this Agreement; or (c) Divert (or permit anyone to divert) any business or opportunity of Borrower to any other corporate or business entity.

(i) Mergers. Borrower shall not merge or consolidate with any Person or sell, assign, lease or otherwise dispose of (whether in one transaction or in a series of transactions) all or substantially all of its assets (whether now owned or hereafter acquired) or acquire all or substantially all of the assets or the business of any Person (or enter into any agreement to do any of the foregoing).

(j) No Activities Leading to Forfeiture. Borrower shall not engage in the conduct of any business or activity which could result in a Forfeiture Proceeding.

(k) Corporate Documents; Fiscal Year. Borrower shall not amend, modify or supplement its certificate or articles of incorporation or by-laws in any way which would adversely affect the ability of Borrower to perform its obligations hereunder. Borrower shall not change its fiscal year.

(l) Capital Expenditures. Other than for a capital expenditure contained in any budget approved by the Board of Directors, including a majority of the directors designated by the purchasers pursuant to the terms and conditions of Debenture and Warrant Purchase Agreement, or capital expenditures not contained in any such budget, but which do not exceed $100,000 in the aggregate during any fiscal year of Borrower, make or commit to make any capital expenditures.

SECTION 8. REGISTRATION RIGHTS

8.1. Restrictive Legend. Each certificate representing

(a) any Note, the Warrants or any Conversion Shares, any Warrant Shares or other securities issued with respect to the Notes, Warrants, Conversion Shares or Warrant Shares, upon any stock split, stock dividend, recapitalization, merger, consolidation or similar event or upon the exercise of the Warrants or conversion of the Notes, shall be stamped or otherwise imprinted with a legend in the following form (in addition to any legend required under applicable state securities laws):

"THIS [NAME OF SECURITY] [AND THE COMMON STOCK ISSUABLE UPON [CONVERSION]
[EXERCISE] HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF

1933, AS AMENDED, NOR ANY STATE SECURITIES LAW AND MAY NOT BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR OTHERWISE TRANSFERRED UNTIL (1)

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A REGISTRATION STATEMENT WITH RESPECT THERETO IS EFFECTIVE UNDER THE ACT AND ANY APPLICABLE STATE SECURITIES LAW OR (2) BORROWER RECEIVES AN OPINION OF COUNSEL TO BORROWER OR OTHER COUNSEL TO THE HOLDER OF SUCH
[NAME OF SECURITY] REASONABLY SATISFACTORY TO BORROWER THAT SUCH [NAME OF

SECURITY] [AND/OR COMMON STOCK] MAY BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR APPLICABLE STATE SECURITIES LAWS."

8.2. Certain Definitions As used in this Section 8, the following terms shall have the following respective meanings:

"Holders" shall mean Lenders or any person to whom a Lender or transferee of a Lender has assigned any Note, Warrants, Conversion Shares or Warrant Shares.

"Initiating Holders" shall mean any persons who in the aggregate are Holders of at least a majority of the Conversion Shares and the Warrant Shares.

"Registrable Securities" shall mean any Conversions Shares and Warrant Shares issued upon exercise of the Warrants, conversion of any Note or in respect of the Conversion Shares and Warrant Shares issued upon exercise of the Warrants or conversion of any Note upon any stock split, stock dividend, recapitalization or similar event.

"Requesting Stockholders'" shall mean holders of securities of Borrower entitled to have securities included in any registration pursuant to
Section 8.3 and who shall request such inclusion.

The terms "register," "registered" and "registration" shall refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act and applicable rules and regulations thereunder, and the declaration or ordering of the effectiveness of such registration statement.

"Registration Expenses" shall mean all expenses incurred by Borrower in compliance with Sections 8.3 and 8.4 hereof, including, without limitation, all registration and filing fees, printing expenses, fees and disbursements of counsel for Borrower, blue sky fees and expenses, reasonable fees and disbursements of one counsel for all the selling Holders for a "due diligence" examination of Borrower, and the expense of any special audits incident to or required by any such registration (but excluding the compensation of regular employees of Borrower, which shall be paid in any event by Borrower), exclusive of Selling Expenses.

"Restricted Securities" shall mean the securities of Borrower required to bear or bearing the legend set forth in Section 8.1 hereof.

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"Selling Expenses" shall mean all underwriting discounts and selling commissions applicable to the sale of Registrable Securities and all fees and disbursements of counsel for any Holder, except as otherwise provided herein.

8.3. Requested Registration.

(a) Requests for Registration. The Initiating Holders may request registration under the Securities Act of all or part of their Registrable Securities. Within ten (10) days after receipt of any such request, Borrower will give written notice of such requested registration to all other Holders of Registrable Securities and any other stockholder having registration rights which entitle it to participate in such registration. Borrower will include in such registration all Registrable Securities with respect to which it has received written requests for inclusion therein within fifteen (15) days after receipt of Borrower's notice. Borrower shall cause its management to cooperate fully and to use its best efforts to support the registration of the Registrable Securities and the sale of the Registrable Securities pursuant to such registration as promptly as is practicable. Such cooperation shall include, but not be limited to, management's attendance and reasonable presentations in respect of Borrower at road shows with respect to the offering of Registrable Securities. The registration requested under this Section 8.3(a) is referred to herein as a "Demand Registration."

(b) Number of Registrations. The Holders of Registrable Securities will be entitled to request one (1) Demand Registration for which Borrower will pay all Registration Expenses. A registration will not count as a Demand Registration until it has become effective; provided, however, that whether or not it becomes effective, Borrower will pay all Registration Expenses in connection with any registration so initiated.

(c) Priority on Demand Registrations. If a Demand Registration is an underwritten offering, and the managing underwriters advise Borrower in writing that in their opinion the number of Registrable Securities requested to be included exceeds the number which can be sold in such offering, Borrower will include in such registration such number of Conversion Shares and Warrant Shares, which in the opinion of such underwriters, may be sold, allocated among the Holders electing to participate pro rata in accordance with the amounts of securities requested to be so included by the respective Holders. Borrower will not include in any Demand Registration any securities which are not Registrable Securities without the written consent of the Holders of a majority of the Registrable Securities requesting such registration. Any persons other than Holders of Registrable Securities who participate in a Demand Registration which is not at Borrower's expense must pay their share of the Registration Expenses. A registration shall not count as a Demand Registration if some or all of the Conversion Shares and Warrant Shares which any Holder desires to include therein are not included due to the determination of the managing underwriters referred to in the first sentence of this Section 8.3(c).

(d) Restrictions on Demand Registrations. Borrower will not be obligated to effect any Demand Registration within six (6) months after the effective date of a previous registration in which the Holders of Registrable Securities were given piggyback rights pursuant to Section 8.4 other than a registration of Registrable Securities intended to be offered on a continuous

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or delayed basis under Rule 415 or any successor rule under the Securities Act (a "Shelf Registration").

8.4. Piggyback Registrations.

(a) Right to Piggyback. Whenever Borrower proposes to register any of its securities under the Securities Act (other than pursuant to a Demand Registration or pursuant to a registration on Forms S-4 or S-8 or any successors to such forms) and the registration form to be used may be used for the registration and contemplated disposition of Registrable Securities (a "Piggyback Registration"), Borrower will give prompt written notice to all Holders of Registrable Securities of its intention to effect such a registration. Borrower will include in such registration all Registrable Securities with respect to which Borrower has received written requests for inclusion therein within thirty (30) days after the receipt of Borrower's notice.

(b) Piggyback Expenses. The Registration Expenses of the Holders of Registrable Securities will be paid by Borrower.

(c) Priority on Primary Registrations. If a Piggyback Registration is an underwritten primary registration on behalf of Borrower, and the managing underwriters advise Borrower in writing that in their opinion the number of securities requested to be included in such registration exceeds the number which can be sold in such offering, Borrower will include in such registration first, the securities Borrower proposes to sell, second, the Registrable Securities and securities of Borrower with respect to which similar registration rights have been granted and requested to be included in such registration, pro rata in accordance with the amounts of Registrable Securities and such securities requested to be so included by the respective Holders and holders of such securities of Borrower; and third, any other securities requested to be included in such registration.

(d) Priority on Secondary Registrations. If a Piggyback Registration is an underwritten secondary registration on behalf of holders of Borrower's securities, and the managing underwriters advise Borrower in writing that in their opinion the number of securities requested to be included in such registration exceeds the number which can be sold in such offering, Borrower will include in such registration first, the securities requested to be included therein by the holders requesting such registration, second, the Registrable Securities and securities of Borrower with respect to which similar registration rights have heretofore been granted and requested to be included in such registration, pro rata in accordance with the amounts of Registrable Securities and such securities requested to be so included by the respective Holders and holders of such securities of Borrower, and third, other securities requested to be included in such registration.

(e) Other Restrictions. Borrower hereby agrees that if it has previously filed a registration statement with respect to Registrable Securities pursuant to Section 8.3 or pursuant to this Section 8.4, and if such previous registration has not been withdrawn or abandoned, Borrower will not file or cause to be effected any other registration of any of its equity securities or securities

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convertible or exchangeable into or exercisable for its equity securities under the Securities Act (except on Form S-8 or any other similar form for employee benefit plans), whether on its own behalf or at the request of any holder or holders of such securities, until a period of at least six (6) months has elapsed from the effective date of such previous registration or, if sooner, until all Registrable Securities included in such previous registration have been sold.

8.5. Holdback Agreements.

(a) Each Holder of Registrable Securities which is a party to this Agreement agrees not to effect any public sale or distribution of equity securities of Borrower, or any securities convertible into or exchangeable or exercisable for such securities, during the seven (7) days prior to and the 90-day period beginning on the effective date of any underwritten Demand Registration or any underwritten Piggyback Registration (except as part of such underwritten registration) or, if sooner, until all Registrable Securities included within such registration have been sold.

(b) Borrower agrees (i) not to effect any public sale or distribution of its equity securities, or any securities convertible into or exchangeable or exercisable for such securities, during the seven (7) days prior to and the 90-day period beginning on the effective date of any underwritten Demand Registration or any underwritten Piggyback Registration (except as part of such underwritten registration or pursuant to registrations on Form S-8 or any other similar form for employee benefit plans) or, if sooner, until all Registrable Securities included within such registration have been sold, and
(ii) to use its reasonable best efforts to cause each holder of its equity securities, or any securities convertible into or exchangeable or exercisable for such securities, purchased from Borrower at any time after the date of this Agreement (other than in a registered public offering) to agree not to effect any public sale or distribution of any such securities during such period (except as part of such underwritten registration, if otherwise permitted) or, if sooner, until all Registrable Securities included within such registration have been sold.

8.6. Registration Procedures. Whenever the Holders of Registrable Securities have requested that any Registrable Securities be registered pursuant to this Section 8, Borrower will use its reasonable best efforts to effect the registration and the sale of such Registrable Securities in accordance with the intended method of disposition thereof, and pursuant thereto Borrower will as expeditiously as possible:

(a) prepare and file with the Commission a registration statement with respect to such Registrable Securities, which registration statement will state that the Holders of Registrable Securities covered thereby may sell such Registrable Securities either under such registration statement or, at any Holder's proper request, pursuant to Rule 144 (or any similar rule then in effect), and use its best efforts to cause such registration statement to become effective (provided that before filing a registration statement or prospectus or any amendments or supplements thereto, Borrower will furnish to the counsel selected by the Holders of a majority of the Registrable Securities covered

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by such registration statement copies of all such documents proposed to be filed, which documents will be subject to the review of such counsel);

(b) prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to keep such registration statement effective for the period set forth in Section 8.6(j) hereof and comply with the provisions of the Securities Act with respect to the disposition of all securities covered by such registration statement during such period in accordance with the intended methods of disposition by the sellers thereof set forth in such registration statement;

(c) furnish to each seller of Registrable Securities such number of copies of such registration statement, each amendment and supplement thereto, the prospectus included in such registration statement (including each preliminary prospectus) and such other documents as such seller may reasonably request in order to facilitate the disposition of the Registrable Securities owned by such seller;

(d) use its best efforts to register or qualify such Registrable Securities under such other securities or blue sky laws of such jurisdictions as any seller reasonably requests and do any and all other acts and things which may be reasonably necessary or advisable to enable such seller to consummate the disposition in such jurisdictions of the Registrable Securities owned by such seller (provided that Borrower will not be required to qualify generally to do business in any jurisdiction where it would not otherwise be required to qualify but for this subsection, subject itself to taxation in any such jurisdiction, or consent to general service of process in any such jurisdiction);

(e) notify each seller of such Registrable Securities, at any time when a prospectus relating thereto is required to be delivered under the Securities Act, of the happening of any event as a result of which the prospectus included in such registration statement contains an untrue statement of a material fact or omits to state any fact necessary to make the statements therein not misleading, and, at the request of any such seller, Borrower will prepare a supplement or amendment to such prospectus so that, as thereafter delivered to the Lenders of such Registrable Securities, such prospectus will not contain an untrue statement of a material fact or omit to state any fact necessary to make the statements therein not misleading;

(f) cause all such Registrable Securities to be listed on each securities exchange on which similar securities issued by Borrower are then listed;

(g) provide a transfer agent and registrar for all such Registrable Securities not later than the effective date of such registration statement;

(h) enter into such customary agreements (including an underwriting agreement in customary form) and take all such other actions as the Holders of a majority of the Registrable Securities being sold or the underwriters, if any, reasonably request in order to expedite or facilitate

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the disposition of such Registrable Securities (including, without limitation, using its best efforts to effect a stock split or a combination of shares);

(i) make available for inspection by any seller of Registrable Securities, any underwriter participating in any disposition pursuant to such registration statement, and any attorney, accountant or other agent retained by any such seller or underwriter, all financial and other records, pertinent corporate documents and properties of Borrower, and cause Borrower's officers, directors and employees to supply all information reasonably requested by any such seller, underwriter, attorney, accountant or agent in connection with such registration statement; and

(j) keep each registration statement effective until the earlier to occur of (i) the Holder or Holders have completed the distribution described in the registration statement relating thereto (including a Shelf Registration) and
(ii) two (2) years.

8.7. Expenses of Registration. All Registration Expenses incurred in connection with a registration, qualification or compliance pursuant to this
Section 8 shall be borne by Borrower, and all Selling Expenses shall be borne by the Holders and the Requesting Stockholders of the securities so registered pro rata on the basis of the number of their shares so registered; provided, however, that Borrower shall not be required to pay any Registration Expenses if, as a result of the withdrawal of a request for registration by Initiating Holders, the registration statement does not become effective, in which case the Holders and Requesting Stockholders requesting registration shall bear such Registration Expenses pro rata on the basis of the number of their shares so included in the registration request, and, further, that such registration shall not be counted as a Demand Registration pursuant to Section 8.3.

8.8. Indemnification.

(a) Borrower will indemnify each Holder, each Holder's officers, directors and partners, and each person controlling such Holder, with respect to which registration, qualification or compliance of such Holder's securities has been effected pursuant to this Section 8, and each underwriter, if any, and each person who controls any underwriter, against all claims, losses, damages and liabilities (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any registration statement, prospectus, offering circular or other document (including any related registration statement notification or the like) incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, or any violation by Borrower of the Securities Act or any rule or regulation thereunder applicable to Borrower and relating to action or inaction required of Borrower in connection with any such registration, qualification or compliance, and will reimburse each such Holder, each Holder's officers, directors and partners, and each person controlling such Holder, each such underwriter and each person who controls any such underwriter, for any legal and any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action, provided, that Borrower will not be liable in any such case

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to the extent that any such claim, loss, damage, liability or action arises out of or is based on any untrue statement or omission of material fact based upon written information furnished to Borrower by such Holder or underwriter and stated to be specifically for use therein.

(b) Each Holder and Requesting Stockholder will, if Registrable Securities held by it are included in the securities as to which such registration, qualification or compliance is being effected, indemnify Borrower, each of Borrower's directors and officers and each underwriter, if any, of Borrower's securities covered by such registration statement, each person who controls Borrower or such underwriter within the meaning of the Securities Act and the rules and regulations thereunder, each other Holder and Requesting Stockholder and each of their officers, directors and partners, and each person controlling such Holder or Requesting Stockholder, against all claims, losses, damages and liabilities (or actions in respect thereof) arising out of or based on any untrue statement (or alleged untrue statement) of a material fact contained in any such registration statement, prospectus, offering circular or other document incident to any such registration, qualification or compliance, or based on any omission (or alleged omission) to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse Borrower, its officers and directors, each underwriter, each person controlling Borrower or such underwriter, each other Holder and Requesting Stockholders, their officers, directors, partners and control persons for any legal or any other expenses reasonably incurred in connection with investigating or defending any such claim, loss, damage, liability or action, in each case to the extent, but only to the extent, that such untrue statement (or alleged untrue statement) or omission (or alleged omission) is made in such registration statement, prospectus, offering circular or other document in reliance upon and in conformity with written information furnished to Borrower by such Holder or Requesting Stockholder and stated to be specifically for use therein; provided, however, that the obligations of each Holder and Requesting Stockholders hereunder shall be limited to an amount equal to the proceeds to each such Holder or Requesting Stockholder of securities sold as contemplated herein.

(c) Each party entitled to indemnification under this Section 8.8 (the "Indemnified Party") shall give notice to the party required to provide indemnification (the "Indemnifying Party") promptly after such Indemnified Party has actual knowledge of any claim as to which indemnity may be sought, and shall permit the Indemnifying Party to assume the defense of any such claim or any litigation resulting therefrom, provided, that counsel for the Indemnifying Party, who shall conduct the defense of such claim or any litigation resulting therefrom, shall be approved by the Indemnified Party (whose approval shall not be unreasonably withheld and for such purpose approval is hereby given for Wolf, Block, Schorr and Solis-Cohen LLP ("Wolf, Block") to be such counsel), and the Indemnified Party may participate in such defense at such party's expense, and provided, further, that the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Section 8 unless such failure has had a Material Adverse Effect on such claim. The parties to this Agreement reserve any rights to claim under this Agreement for damages actually incurred by reason of any failure of the Indemnified Party to give prompt notice of a claim. To the extent counsel for the Indemnifying Party shall in such counsel's reasonable judgment, have a conflict in representing an Indemnified Party in conjunction with the

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Indemnifying Party or other Indemnified Parties, such Indemnified Party shall be entitled to separate counsel at the expense of the Indemnifying Party subject to the approval of such counsel by the Indemnified Party (whose approval shall not be unreasonably withheld and for such purpose approval is hereby given for Wolf, Block to be such counsel). No Indemnifying Party, in the defense of any such claim or litigation, shall, except with the consent of each Indemnified Party, consent to entry of any judgment or enter into any settlement which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability with respect to such claim or litigation. Each Indemnified Party shall furnish such information regarding itself or the claim in question as an Indemnifying Party may reasonably request in writing and as shall be reasonably required in connection with the defense of such claim and any litigation resulting therefrom.

8.9. Information by Holders. Each Holder of Registrable Securities, and each Requesting Stockholder holding securities included in any registration, shall furnish to Borrower such information regarding such Holder or Requesting Stockholder and the distribution proposed by such Holder or Requesting Stockholder as Borrower may reasonably request in writing and as shall be reasonably required in connection with any registration, qualification or compliance referred to in this Section 8.

8.10. Limitations on Registration of Issues of Securities. From and after the date of this Agreement, Borrower shall not enter into any agreement with any holder or prospective holder of any securities of Borrower giving such holder or prospective holder the right to require Borrower to register any securities of Borrower equal to or more favorable than the rights granted under this Section
8. Any right given by Borrower to any holder or prospective holder of Borrower's securities in connection with the registration of securities shall be conditioned such that it shall be consistent with the provisions of this Section 8 and with the rights of the Holders provided in this Agreement and such holder or prospective holder agrees to be bound by the terms of this Section 8.

8.11. Rule 144 Reporting. With a view to making available the benefits of certain rules and regulations of the Commission which may permit the sale of the Restricted Securities to the public without registration, Borrower agrees to:

(a) make and keep public information available, as those terms are understood, defined and interpreted in and under Rule 144 under the Securities Act, at all times from and after ninety (90) days following the effective date of the first registration under the Securities Act filed by Borrower for an offering of its securities to anyone other than its employees;

(b) use its best efforts to file with the Commission in a timely manner all reports and other documents required of Borrower under the Securities Act and the Exchange Act at any time after it has become subject to such reporting requirements; and

(c) so long as Lender owns any Restricted Securities, furnish to Lender forthwith, upon request, a written statement by Borrower as to its compliance with the reporting requirements of Rule 144 (at any time from and after ninety (90) days following the effective date of the first

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registration statement filed by Borrower for an offering of its securities to anyone other than its employees), and of the Securities Act and the Exchange Act (at any time after it has become subject to such reporting requirements), a copy of the most recent annual or quarterly report of Borrower, and such other reports and documents so filed as Lender may reasonably request in availing itself of any rule or regulation of the Commission allowing Lender to sell any such securities without registration.

8.12. Participation in Underwritten Registrations. No person may participate in any underwritten registration hereunder unless such person agrees to sell such person's securities on the basis provided in any underwriting arrangements approved by the persons entitled hereunder to approve such arrangements and completes and executes all reasonable questionnaires, powers of attorney, indemnities, underwriting agreements and other documents required under the terms of such underwriting arrangements.

8.13. Selection of Underwriters. If any Demand Registration is an underwritten offering, the Holders of a majority of the Registrable Securities included in such registration have the right to select the investment banker(s) and manager(s) to administer the offering, subject to the approval of Borrower (which approval will not be unreasonably withheld). If any registration other than a Demand Registration is an underwritten offering, Borrower will have the right to select the investment banker(s) and manager(s) to administer the offering, subject to the approval of the Holders of a majority of the Registrable Securities included in such registration (which approval will not be unreasonably withheld).

8.14. Termination of Registration Rights. The rights of Holders to request a Demand Registration or participate in a Piggyback Registration shall expire on May 30, 2003.

SECTION 9. EVENTS OF DEFAULT AND REMEDIES

9.1. Events of Default. The occurrence of any of the following events shall constitute an Event of Default hereunder:

(a) Failure to Pay. Borrower shall fail to pay any of its Obligations when the same shall become due and payable.

(b) Breach of Certain Covenants. Borrower shall fail to comply with any covenant contained in Sections 6 or 7 hereof ("Affirmative Covenants" and "Negative Covenants"), which, in the case of Borrower's failure to comply with the covenants contained in Sections 6.1 and 6.13 above, continues for a period of ten (10) days following Borrower's receipt of written notice thereof from the Agent.

(c) Breach of Representation or Warranty. Any representation or warranty made or deemed to be made by Borrower in this Agreement or in any other Bridge Loan Document (and

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in any statement or certificate given under this Agreement or any other Bridge Loan Document), shall be false or misleading in any material respect when made or deemed to be made.

(d) Breach of Other Covenants. Borrower shall fail to comply with any covenant contained in this Agreement or any other Bridge Loan Document, other than as set forth in Section 10.1(b), and such failure shall continue for ten (10) Business Days after its occurrence.

(e) Cross Default. There shall occur any default or event of default on the part of any Borrower under (i) any agreement, document or instrument to which Borrower is a party or by which Borrower or any of its property is bound, creating or relating to any indebtedness (other than the Obligations), the unpaid principal balance of which is in excess of $100,000, if the payment or maturity of such indebtedness is accelerated in consequence of such event of default or demand for payment of such indebtedness is made or (ii) the Debenture and Warrant Purchase Agreement.

(f) Dissolution, etc. Borrower shall cease to do business, take steps to wind-up or dissolve or shall suffer the appointment of a receiver, trustee, examiner, custodian or similar fiduciary, or shall make an assignment for the benefit of creditors.

(g) Bankruptcy, etc.. Borrower (i) shall generally not, or be unable to, or shall admit in writing its inability to, pay its debts as such debts become due; (ii) shall make an assignment for the benefit of creditors, petition or apply to any tribunal for the appointment of a custodian, receiver or trustee for it or a substantial part of its assets; (iii) shall commence any proceeding under any bankruptcy, reorganization, arrangement, readjustment of debt, dissolution or liquidation law or statute of any jurisdiction, whether now or hereafter in effect; (iv) shall have had any such petition or application filed or any such proceeding shall have been commenced, against it, in which an adjudication or appointment is made or order for relief is entered, or which petition, application or proceeding remains undismissed for a period of 30 days or more; or shall be the subject of any proceeding under which its assets may be subject to seizure, forfeiture or divestiture; (v) by any act or omission shall indicate its consent to, approval of or acquiescence in any such petition, application or proceeding or order for relief or the appointment of a custodian, receiver or trustee for all or any substantial part of its property; (vi) shall suffer any such custodianship, receivership or trusteeship to continue discharged for a period of 30 days or more; or (vii) shall cease to be Solvent.

(h) Judgments. One or more judgments, decrees or orders for the payment of money in excess of $100,000 in the aggregate shall be rendered against Borrower, and such judgments, decrees, or orders shall continue unsatisfied and in effect for a period of 30 consecutive days without being vacated, discharged, satisfied or stayed or bonded pending appeal.

(i) Forfeiture Proceeding. Any Forfeiture Proceeding shall have been commenced against Borrower.

9.2. Acceleration. Upon the occurrence and during the continuance of any Event of Default, without prejudice to the rights of any Lender to enforce its claims against Borrower and by

39

delivery of written notice to Borrower from Agent on behalf of Lenders, all Obligations shall be immediately due and payable (except with respect to any Event of Default set forth in Section 9.1(f) or (g) hereof, in which case all Obligations shall automatically become immediately due and payable without the necessity of any notice or other demand to Borrower) without presentment, demand, protest or any other action or obligation of Lenders.

9.3. Remedies.

(a) Upon the occurrence of an Event of Default, Majority Holders may at any time (unless all defaults shall theretofore have been remedied) at its or their option, by written notice or notices to the Company (i) declare all the Notes to be due and payable, whereupon the same shall forthwith mature and become due and payable, together with interest accrued thereon, without presentment, demand, protest or notice, all of which are hereby waived; and (ii) declare any other amounts payable to the Lenders under this Agreement or as contemplated hereby due and payable.

(b) Notwithstanding anything contained in Section 9.3(a), if, at any time after the principal of the Notes shall so become due and payable and prior to the date of maturity stated in the Notes all arrears of principal of and interest on the Notes (with interest at the rate specified in the Notes on any overdue principal and, to the extent legally enforceable, on any interest overdue) shall be paid by or for the account of the Company, then Majority Holders, by written notice(s) to the Company, may (but shall not be obligated to) waive such Event of Default and its consequences and rescind or annul such declaration; but no such waiver shall extend to or affect any subsequent Event of Default or impair any right resulting therefrom. If any holder of a Note shall give any notice or take any other action with respect to a claimed Default, the Company, forthwith upon receipt of such notice or obtaining knowledge of such other action will give written notice thereof to all other holders of the Notes then outstanding, describing such notice or other action and, the nature of the claimed Default.

9.4. Application of Proceeds; Surplus; Deficiencies. The net cash proceeds resulting from Agent's exercise of any of the foregoing rights against any Collateral (after deducting all of Lenders' Expenses related thereto) shall be applied by Agent to the payment of the Obligations, whether due or to become due, in the order set forth in Section 2.9. Borrower shall remain liable to Lenders for any deficiencies, and Lenders in turn agree to remit to Borrower or its successors or assigns, any surplus resulting therefrom.

SECTION 10. GENERAL PROVISIONS

10.1. GOVERNING LAW. THE VALIDITY, INTERPRETATION AND ENFORCEMENT OF THIS AGREEMENT AND THE OTHER BRIDGE LOAN DOCUMENTS AND ANY DISPUTE ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE BRIDGE LOAN DOCUMENTS, WHETHER SOUNDING IN CONTRACT, TORT, EQUITY OR OTHERWISE, SHALL BE GOVERNED BY THE INTERNAL LAWS (AS

40

OPPOSED TO THE CONFLICTS OF LAWS PROVISIONS) AND DECISIONS OF THE STATE OF NEW YORK.

10.2. SUBMISSION TO JURISDICTION. ALL DISPUTES AMONG BORROWER AND LENDERS, WHETHER SOUNDING IN CONTRACT, TORT, EQUITY OR OTHERWISE, SHALL BE RESOLVED ONLY BY STATE AND FEDERAL COURTS LOCATED IN NEW YORK, NEW YORK, AND THE COURTS TO WHICH AN APPEAL THEREFROM MAY BE TAKEN; PROVIDED, HOWEVER, THAT LENDERS SHALL HAVE THE RIGHT, TO THE EXTENT PERMITTED BY APPLICABLE LAW, TO PROCEED AGAINST BORROWER OR ITS PROPERTY IN ANY LOCATION REASONABLY SELECTED BY LENDERS IN GOOD FAITH TO ENABLE LENDERS TO REALIZE ON SUCH PROPERTY, OR TO ENFORCE A JUDGMENT OR OTHER COURT ORDER IN FAVOR OF LENDERS. BORROWER AGREES THAT IT WILL NOT ASSERT ANY PERMISSIVE COUNTERCLAIMS, SETOFFS OR CROSS-CLAIMS IN ANY PROCEEDING BROUGHT BY LENDERS. BORROWER WAIVES ANY OBJECTION THAT THEY MAY HAVE TO THE LOCATION OF THE COURT IN WHICH LENDERS HAS COMMENCED A PROCEEDING, INCLUDING, WITHOUT LIMITATION, ANY OBJECTION TO THE LAYING OF VENUE OR BASED ON FORUM NON CONVENIENS.

10.3. SERVICE OF PROCESS. BORROWER HEREBY IRREVOCABLY AGREES THAT SERVICE OF PROCESS IN ANY LEGAL ACTION OR PROCEEDING WITH RESPECT TO THIS AGREEMENT OR ANY OTHER BRIDGE LOAN DOCUMENT MAY BE AFFECTED BY MAILING A COPY THEREOF BY REGISTERED OR CERTIFIED MAIL, POSTAGE PREPAID, TO BORROWER AT ITS RESPECTIVE ADDRESS SET FORTH IN SECTION 10.6.

10.4. JURY TRIAL. BORROWER, AGENT AND LENDERS EACH HEREBY WAIVE ANY RIGHT TO A TRIAL BY JURY.

10.5. LIMITATION OF LIABILITY. NEITHER AGENT NOR ANY OF THE LENDERS SHALL HAVE ANY LIABILITY TO BORROWER (WHETHER SOUNDING IN TORT, CONTRACT, OR OTHERWISE) FOR LOSSES SUFFERED BY BORROWER IN CONNECTION WITH, ARISING OUT OF, OR IN ANY WAY RELATED TO THE TRANSACTIONS OR RELATIONSHIPS CONTEMPLATED BY THIS AGREEMENT, OR ANY ACT, OMISSION OR EVENT OCCURRING IN CONNECTION THEREWITH, UNLESS IT IS DETERMINED BY A FINAL AND NONAPPEALABLE JUDGMENT OR COURT ORDER BINDING ON LENDERS, THAT THE LOSSES WERE THE RESULT OF ACTS OR OMISSIONS CONSTITUTING GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

10.6. Notices. Except as otherwise provided herein, all notices and correspondences hereunder shall be in writing and sent by certified or registered mail, return receipt requested, or by overnight delivery service, with all charges prepaid, or by facsimile transmission, promptly confirmed in writing sent by first class mail:

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If to any Lender then to Agent, as follows:

Mr. Srini Conjeevaram
Galen Partners III, L.P.

Rockefeller Center
610 Fifth Avenue, 5th Floor
New York, New York 10020

With copies to:

Wolf, Block, Schorr and Solis-Cohen LLP 250 Park Avenue
New York, New York 10177 Attention: George N. Abrahams, Esq.

Fax no. (212) 986-0604

If to Borrower:

Halsey Drug Co., Inc.
695 N. Perryville Road
Rockford, Illinois 61107

Attention: Mr. Michael Reicher Fax no. (815) 399-9710

With copies to:

St. John & Wayne LLC
Two Penn Plaza East
Newark, New Jersey 07105-2249 Attention: John P. Reilly, Esq.

Fax no. (973) 491-3555

All such notices and correspondence shall be deemed given (i) if sent by certified or registered mail, three Business Days after being postmarked, (ii) if sent by overnight delivery service, when received at the above stated addresses or when delivery is refused and (iii) if sent by telex or facsimile transmission, when receipt of such transmission is acknowledged.

10.7. Indemnification. Borrower hereby indemnifies and agrees to defend and hold harmless Agent, each of the Lenders and their respective partners, directors, officers, agents, employees and counsel from and against any and all losses, claims, damages, liabilities, deficiencies, judgments or expenses incurred by any of them (except to the extent that it is finally judicially determined to have resulted from their own gross negligence or willful misconduct) arising out of or by reason of (a) any litigations, investigations, claims or proceedings which arise out of or are in any way related to (i) this Agreement or the transactions contemplated hereby, (ii) any actual or

42

proposed use by Borrower of the proceeds of the Consolidated Bridge Loan or Lenders entering into this Agreement, the other Bridge Loan Documents or any other agreements and documents relating hereto, including, without limitation, amounts paid in settlement, court costs and the fees and disbursements of counsel incurred in connection with any such litigation, investigation, claim or proceeding or any advice rendered in connection with any of the foregoing and
(b) any remedial or other action taken by Borrower or Lenders in connection with compliance by Borrower, or any of its property, with any federal, state or local environmental laws, acts, rules, regulations, orders, directions, ordinances, criteria or guidelines.

10.8. Amendments and Waivers. This Agreement may not be amended, discharged or terminated (or any provision hereof waived) without the written consent of Borrower and the Lenders as set forth below:

(a) Holders of at least fifty one percent (51%) in aggregate principal amount of the Notes then outstanding may by written instrument amend or waive any term or condition of this Agreement, except that no such amendment or waiver shall (i) except as otherwise permitted in Section 2.3(f) hereof with respect to voluntary prepayments of the Notes by the Borrower, extend the fixed maturity of any Notes, the rate or the time of payment or mandatory prepayment of principal thereof or payment of interest thereon, or the principal amount thereof, without the consent of the holders of the Notes so affected, (ii) change the aforesaid percentage of Notes, the holders of which are required to consent to any such amendment or waiver, without the consent of the holders of all the Notes then outstanding or (iii) change the percentage of the amount of the Notes, the holders of which may declare the Notes to be due and payable under Section 9.1.

Borrower and each holder of a Note then or thereafter outstanding shall be bound by any amendment or waiver effected in accordance with the provisions of this Section 10.8, whether or not such Note shall have been marked to indicate such modification, but any Note issued thereafter shall bear a notation as to any such modification. Promptly after obtaining the written consent of the holders herein provided, Borrower shall transmit a copy of such modification to all of the holders of the Notes then outstanding.

(b) Holders of at least a majority of the Conversion Shares and the Warrant Shares in the aggregate then outstanding may by written instrument amend or waive any term or condition of this Agreement relating to the rights or obligations of holders of Conversion Shares and Warrant Shares, which amendment or waiver operates for the benefit of such holders but in no event shall the obligation of any holder of Conversion Shares and Warrant Shares hereunder be increased, except upon the written consent of such holder of Conversion Shares and Warrant Shares.

Borrower and each holder of a Conversion Share or a Warrant Share then or thereafter outstanding shall be bound by any amendment or waiver effected in accordance with the provisions of this Section 10.8, whether or not such Conversion Share or Warrant Share shall have been marked to indicate such modification, but any Conversion Share and Warrant Share issued thereafter shall bear a notation as to any such modification. Promptly after obtaining the written consent of the

43

holders herein provided, Borrower shall transmit a copy of such modification to all of the holders of the Conversion Shares and the Warrant Shares then outstanding.

10.9. Construction. Unless the context of this Agreement clearly requires otherwise, references to the plural include the singular, references to the singular include the plural, the term "including" is not limiting, and the term "or" has, except where otherwise indicated, the inclusive meaning represented by the phrase "and/or." The words "hereof," "herein," "hereby," "hereunder," and similar terms in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement. Article, Section, subsection, paragraph, clause, schedule, and exhibit references are to this Agreement unless otherwise specified. Any reference in this Agreement shall include all alterations, amendments, changes, extensions, modifications, renewals, replacements, substitutions, and supplements, thereto and thereof, as applicable.

10.10. Counterparts and Effectiveness. This Agreement and any waiver or amendment hereto may be executed in any number of counterparts and by the different parties hereto in separate counterparts, each of which when so executed and delivered shall be an original, but all of which shall together constitute one and the same instrument. This Agreement shall become effective on the date on which all of the parties hereto shall have signed a copy hereof (whether the same or different copies) and shall have delivered the same to Lenders pursuant to Section 10.6 or shall have given to Lenders written, telecopied or telex notice (actually received) at such office that the same has been signed and mailed to it.

10.11. Severability. In case any provision in or obligation under this Agreement or any Note or the other Bridge Loan Documents shall be invalid, illegal or unenforceable in any jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

10.12. Entire Agreement; Successors and Assigns. This Agreement and the other Bridge Loan Documents constitute the entire agreement among Borrower and Lenders, supersedes any prior agreements among them, and shall bind and benefit Borrower and Lenders and their respective successors and assigns.

10.13 Assignments and Participations.

(a) Each Lender may assign its rights and delegate its obligations under this Agreement and further may assign, or sell participations in, all or any part of the Consolidated Bridge Loan, such Lender's Total Commitment or any other interest herein to an Affiliate or to another Person. In the case of an assignment authorized under this Section 10.13, the assignee shall have, to the extent of such assignment, the same rights, benefits and obligations as it would if it were a Lender hereunder, shall be deemed to be a Lender for all purposes, and such assigning Lender shall be relieved of its obligations hereunder with respect to such Lender's Total Commitment or assigned portion thereof. Borrower hereby acknowledges and agrees that any assignment will give rise to a direct obligation of Borrower to the assignee and that the assignee shall be considered to be a

44

"Lender". Any such Lender may furnish any information concerning Borrower and its Subsidiaries in its possession from time to time to assignees and participants (including prospective assignees and participants).

(b) The Borrower and the Lenders hereby authorize the Agent to modify this Agreement by unilaterally amending or supplementing Exhibit A to reflect the assignment by a Lender of all or any part of its Total Commitment to any other Lender hereunder or to any Person whatsoever, and to reflect the Total Commitment of any Person that elects to become a Lender after the date hereof by extending a new loan to Borrower.

10.14 No Brokers. Each Lender and Borrower represents and warrants to each other that it has not employed or dealt with any broker in connection with any transactions contemplated by this Agreement and each of Lender and the Borrower shall indemnify and hold harmless the other from and against any and all claims at any time heretofore or hereafter made for broker's or finder's fees or commissions, which claim or claims arise from, out of, or in connection with any of the transactions contemplated by this Agreement.

10.15 No Novation. This Agreement amends and restates in its entirety the Original Bridge Loan Agreement and consolidates the Original Bridge Loan with the Additional Bridge Loan. Neither this Agreement nor any of the Notes creates a novation of or in any manner diminishes or extinguishes the unpaid principal balance of, or the accrued interest on, Borrower's indebtedness to Lenders originally evidenced by the Original Notes. Such unpaid principal balance of, and such accrued interest on, such indebtedness continues to be due and owing by Borrower to Lenders, as of the date hereof, and Borrower hereby reaffirms and confirms same.

[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in the state of New York, and delivered by their proper and duly authorized officers and representatives as of the date set forth above.

Borrower:         HALSEY DRUG CO., INC.

                  By: /s/
                      ------------------------------
                  Name:  Michael Reicher
                  Title: Chief Executive Officer


Lenders:          GALEN PARTNERS III, L.P.
                  By: Claudius, L.L.C., General Partner

                  By: /s/
                      ------------------------------
                  Name:  Bruce F. Wesson
                  Title: Managing Member

                  GALEN PARTNERS INTERNATIONAL III, L.P.
                  By: Claudius, L.L.C., General Partner

                  By: /s/
                      ------------------------------
                  Name:  Bruce F. Wesson
                  Title: Managing Member


                  GALEN EMPLOYEE FUND  III, L.P.
                  By: Wesson Enterprises, Inc., General Partner

                  By: /s/
                      ------------------------------
                  Name:  Bruce F. Wesson
                  Title: President

                  /s/
                  ----------------------------------
                  Michael Weisbrot

                  /s/
                  ----------------------------------
                  Susan Weisbrot

46

Exhibit 10.46

[First Amendment to Amended, Restated and Consolidated Bridge Loan Agreement dated December 7, 1998 between the Company and the lenders listed on the signature page thereto]

Execution Copy

FIRST AMENDMENT
TO
AMENDED, RESTATED AND CONSOLIDATED
BRIDGE LOAN AGREEMENT

THIS FIRST AMENDMENT TO AMENDED, RESTATED AND CONSOLIDATED BRIDGE LOAN AGREEMENT (the "First Amendment") dated as of December 7, 1998 by and among HALSEY DRUG CO., INC., a New York corporation ("Borrower"), GALEN PARTNERS III, L.P. ("Galen", an "Initial Lender" or a "Lender") a Delaware limited partnership, GALEN PARTNERS INTERNATIONAL III, L.P. and GALEN EMPLOYEE FUND III, L.P., each a Delaware limited partnership (each an "Initial Lender", a "Lender", and collectively, with Galen, the "Galen Entities"), PATRICK COYNE ("Coyne", a "First Amendment Lender" or a "Lender"), an individual residing at 477 Margo Lane, Berwyn, Pennsylvania 19312, ALAN SMITH ("Smith", a "First Amendment Lender" or a "Lender"), an individual residing at 21 Bedlow Avenue, Newport, Rhode Island 02840, MICHAEL WEISBROT AND SUSAN WEISBROT (collectively, the "Weisbrots" or jointly and severally, with respect to the Initial Commitment, an "Initial Lender", with respect to the First Amendment Commitment, a "First Amendment Lender" or a "Lender"), individuals residing at 1136 Rock Creek Road, Gladwyne, Pennsylvania 19035, GREG WOOD ("Wood", a "First Amendment Lender" or a "Lender"), an individual residing at c/o D.R. International, 7474 Figueron Street, Los Angeles, California 90041, (Coyne, Smith, the Weisbrots and Wood, each a "First Amendment Lender" and collectively, the "First Amendment Lenders" and the First Amendment Lenders, together with the Galen Entities and the Weisbrots, each a "Lender", and collectively, the "Lenders"), and GALEN, as agent for the Lenders (in such capacity, the "Agent") to the Amended, Restated and Consolidated Bridge Loan Agreement dated as of December 2, 1998 by and among Borrower, the Galen Entities and the Weisbrots (the Weisbrots and the Galen Entities, each an "Initial Lender", a "Lender" and collectively, the "Initial Lenders", as amended through the date hereof, the "Consolidated Bridge Loan Agreement"). Terms that are capitalized in this First Amendment and not otherwise defined shall have the meaning ascribed to such terms in the Consolidated Bridge Loan Agreement.

WITNESSETH:

WHEREAS, the Borrower and the Initial Lenders have entered into the Consolidated Bridge Loan Agreement;

WHEREAS, Borrower has requested that certain Lenders consider making an additional $283,000 bridge loan ("First Amendment Bridge Loan") available to Borrower, the proceeds of which will be used by Borrower solely for Borrower's working capital purposes and other general


business purposes, in each case pursuant to the Consolidated Bridge Loan Agreement and in accordance with the terms thereof and hereof.

WHEREAS, Borrower and the Lenders have agreed to add Smith, Wood and Coyne as a party to the Consolidated Bridge Loan Agreement effective from the First Amendment Closing Date;

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the recipient and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

SECTION 1. AMENDMENTS

A. Amendment of Section 1. Definitions.

1. Paragraph 1.1 is amended by:

(i) adding thereto, in the appropriate alphabetical order, each of the terms "Agency Agreements", "Agent", "Consents and Waivers", "Consolidated Bridge Loan", "First Amendment", "First Amendment Agency Agreement", "First Amendment Bridge Loan", "First Amendment Closing Date", "First Amendment Closing Fees", "First Amendment Commitment", "First Amendment Consent and Waiver", "First Amendment Conversion Price", "First Amendment Lenders", "First Amendment Loan", "First Amendment Notes", "First Amendment Warrants", "Initial Agency Agreement", "Initial Closing Date", "Initial Commitment", "Initial Consent and Waiver", "Initial Consolidated Bridge Loan", "Initial Consolidated Bridge Loan Agreement", "Initial Conversion Price", "Initial Lenders", "Initial Notes", "Initial Warrants", "Note 1", "Note 2", "Note 3", "Note 4", "Note 5", "Note 6", "Note 7", "Note 8" and the definitions thereof, as hereinafter provided, and

(ii) deleting the definitions of the terms "Agreement", "Bridge Loan Documents", "Lenders", "Notes", "Obligations", "Warrants" and substituting the definitions set forth below in lieu thereof:

"Agency Agreements" mean the Initial Agency Agreement and the First Amendment Agency Agreement.

"Agent" means Galen acting as agent to the Lenders pursuant to the Initial Agency Agreement and the First Amendment Agency Agreement.

"Agreement" means the Initial Consolidated Bridge Loan Agreement, as amended by the First Amendment, as the same may hereafter be further amended, extended, modified, restated or supplemented from time to time.

2

"Bridge Loan Documents" means, collectively, this Agreement, the Notes, the Warrants, the Agency Agreements, the Consents and Waivers, each of the Collateral Documents and all other documents, agreements, instruments, opinions and certificates now or hereafter executed and delivered in connection herewith or therewith, as modified, amended, extended, restated or supplemented from time to time.

"Consents and Waivers" mean the Initial Consent and Waiver and the First Amendment Consent and Waiver.

"Consolidated Bridge Loan" has the meaning set forth in Section I(B)(1) hereto.

"First Amendment" means the First Amendment to the Initial Consolidated Bridge Loan Agreement dated as of December 7, 1998 by and among Borrower, the Lenders and Agent, as the same may hereafter be further amended, extended, modified, restated or supplemented from time to time.

"First Amendment Agency Agreement" means the Agency Agreement by and among the First Amendment Lenders dated the date hereof and entered into simultaneously herewith, substantially in the Form of Exhibit E attached hereto.

"First Amendment Bridge Loan" has the meaning set forth in the Recitals to this Agreement.

"First Amendment Closing Date" means the date upon which the last of the events, the fulfillment of each of which is condition precedent to the effectiveness of this First Amendment, as set forth in Section II of this First Amendment, shall have occurred.

"First Amendment Closing Fees" means the expenses as set forth in
Section II(4) of this First Amendment.

"First Amendment Commitment" means the commitment of each First Amendment Lender to fund the dollar amount of its share of the First Amendment Loan in the amount set forth opposite such Lender's name on Exhibit A, a copy of which is attached hereto and made a part hereof.

"First Amendment Consent and Waiver" means a consent and waiver of lien, indebtedness and registration rights restrictions executed by the Majority Holders in connection with this First Amendment dated the date hereof and executed simultaneously herewith, substantially in the form of Exhibit D attached hereto.

"First Amendment Conversion Price" means $1.3133.

3

"First Amendment Lenders" has the meaning set forth in the Section entitled "Pari Passu and Pro Rata Relationship of the Initial Lenders to the First Amendment Lenders" (Section I(B)(4) hereof).

"First Amendment Notes" mean Note 5, Note 6, Note 7 and Note 8.

"First Amendment Warrants" means the warrants to purchase 28,300 shares, in the aggregate, of the Common Stock, dated the date hereof and issued by Borrower to each of the First Amendment Lenders, substantially in the form of Exhibit C attached hereto.

"Initial Agency Agreement" means a certain Agency Agreement by and among the Agent and each of the Initial Lenders dated as of December 2, 1998 entered into in connection with the Initial Consolidated Bridge Loan Agreement.

"Initial Closing Date" means the Closing Date.

"Initial Commitment" means the Total Commitment of each Initial Lender.

"Initial Consent and Waiver" means a certain consent and waiver of lien, indebtedness and registration rights restrictions executed by the Majority Holders in connection with the Initial Consolidated Bridge Loan Agreement dated as of December 2, 1998.

"Initial Consolidated Bridge Loan" has the meaning set forth in
Section I(B)1 hereof.

"Initial Consolidated Bridge Loan Agreement" means the agreement dated as of December 2, 1998 by and among Borrower, the Initial Lenders and the Agent.

"Initial Conversion Price" means $1.3688.

"Initial Lenders" has the meaning set forth in the Section entitled "Pari Passu and Pro Rata Relationship of the Initial Lenders to the First Amendment Lenders" (Section I(B)(4) hereof).

"Initial Notes" means Note 1, Note 2, Note 3 and Note 4.

"Initial Warrants" mean the warrants dated December 2, 1998 and issued to the Initial Lenders to purchase 689,722 shares, in the aggregate, of the Common Stock.

"Lenders" mean the Initial Lenders and the First Amendment Lenders.

"Note 1" means a certain promissory note dated as of December 2, 1998 payable by Borrower to the order of Galen Partners III, L.P. in the amount of $7,052,621.

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"Note 2" means a certain promissory note dated as of December 2, 1998 payable by Borrower to the order of Galen Partners International III, L.P. in the amount of $638,389.

"Note 3" means a certain promissory note dated as of December 2, 1998 payable by Borrower to the order of Galen Employee Fund III, L.P. in the amount of $28,880.

"Note 4" means a certain promissory note dated as of December 2, 1998 payable by Borrower to the order of Michael Weisbrot and Susan Weisbrot in the amount of $101,222.

"Note 5" means a promissory note dated the date hereof payable by Borrower to the order of Alan Smith in the amount of $8,000, substantially in the form of Exhibit B attached hereto.

"Note 6" means a promissory note dated the date hereof payable by Borrower to the order of Michael Weisbrot and Susan Weisbrot in the amount of $150,000, substantially in the form of Exhibit B.

"Note 7" means a promissory note dated the date hereof payable by Borrower to the order of Greg Wood in the amount of $100,000, substantially in the form of Exhibit B.

"Note 8" means a promissory note dated the date hereof payable by Borrower to the order of Patrick Coyne in the amount of $25,000, substantially in the form of Exhibit B.

"Notes" means Note 1, Note 2, Note 3, Note 4, Note 5, Note 6, Note 7, and Note 8, or any one of the Notes ("Note").

"Obligations" means the unpaid principal and interest hereunder, expenses and all other obligations and liabilities of Borrower to the Lenders under this Agreement, the Notes or any other Bridge Loan Document, and includes, but is not limited to, any and all indebtedness of Borrower to the Lenders, whether now existing or hereafter incurred, of every kind and character, direct or indirect, and whether such indebtedness is from time to time reduced and thereafter increased, or entirely extinguished and thereafter reincurred, including, without limitation: (a) indebtedness not yet outstanding, but contracted for, or with respect to which any other commitment by the Lenders exists; (b) all interest provided in any instrument, document, or agreement (including this Agreement) which accrues on any indebtedness until payment of such indebtedness in full; and (c) any moneys payable as hereinafter provided.

"Warrants" mean the Initial Warrants and the First Amendment Warrants.

5

B. Amendment of Section 2. Terms of the Consolidated Bridge Loan.

1. Section 2.2 of the Agreement is amended in its entirety to read as follows:

"2.2 Initial Consolidated Bridge Loan; Consolidated Bridge Loan.

(a) Initial Consolidated Bridge Loan. Borrower warrants, represents and confirms that, as of the Initial Closing Date,
(i) the aggregate outstanding principal balance of the Original Bridge Loan equals $4,500,000, (ii) the aggregate accrued interest on such principal balance equals $71,111 and
(iii) the aggregate outstanding principal balance of the Additional Bridge Loan equals $3,250,000. Borrower and Lenders agree that effective on the Initial Closing Date, upon the consolidation of the outstanding principal balances of the Original Bridge Loan and the Additional Bridge Loan, and the addition to principal of the accrued interest on the Original Bridge Loan, Lenders shall be deemed to have made a single loan to Borrower in the aggregate principal amount of $7,821,111 (the "Initial Consolidated Bridge Loan").

(b) Consolidated Bridge Loan. Borrower warrants, represents and confirms that, as of the First Amendment Closing Date (i) the aggregate outstanding principal balance of the Original Bridge Loan equals $4,500,000, (ii) the aggregate accrued interest on such principal balance equals $71,111, (iii) the aggregate outstanding principal balance of the Additional Bridge Loan equals $3,250,000 and (iv) the aggregate outstanding principal balance of the First Amendment Loan equals $283,000. Borrower and the Lenders agree that effective on the First Amendment Closing Date, the total amount of funds advanced by the Lenders equals, in the aggregate principal amount $8,104,111 (the "Consolidated Bridge Loan")."

2. Section 2.3(a) of the Agreement is amended in its entirety to read as follows:

"2.3 Amended, Restated and Consolidated Notes.

(a) The Amount. The Initial Consolidated Bridge Loan is evidenced by the Initial Notes and the First Amendment Loan is evidenced by the First Amendment Notes (each of the Initial Notes and the First Amendment Notes, a " Note" and collectively, the "Notes")."

3. Section 2.4 of the Agreement is amended in its entirety to read as follows:

"2.4 Warrants. Subject to the terms of Initial Consolidated Bridge Loan Agreement and the terms of the Initial Warrants, Borrower has issued Initial Warrants to purchase in the aggregate, 689,722 shares of the Common Stock, initially, at a price per share equal to Initial Conversion Price, in the amounts set

6

forth opposite each Initial Lender's name on Exhibit A. Subject to the terms of this First Amendment and the terms of the First Amendment Warrants substantially in the form of Exhibit C, Borrower will issue Warrants to purchase in the aggregate, 28,300 shares of the Common Stock, initially, at a price per share equal to the First Amendment Conversion Price. The First Amendment Warrants shall be issued to each of the First Amendment Lenders in the amounts set forth opposite each First Amendment Lender's name on Exhibit A. For purposes of this Agreement, the term "Warrant Shares", shall mean the shares of Common Stock that may be issued from time to time pursuant to the exercise of the Warrants."

4. The following Section 2.10 is to be added after Section 2.9 of Agreement:

"2.10.Pari Passu and Pro Rata Relationship of the Initial Lenders to the First Amendment Lenders. Until such time as the unpaid principal balance of the Initial Notes, in the original aggregate principal amount of $7,821,111 and the First Amendment Notes, in the original aggregate principal amount of $283,000, shall have been paid in full, or in a manner otherwise satisfactory to the Agent, (i) the Initial Lenders' Lien on the Borrower's Collateral with respect to the Obligations of Borrower to the Initial Lenders under this Agreement, any other Bridge Loan Documents and the Initial Notes, on the one hand, and the Obligations of Borrower to the First Amendment Lenders under this Agreement, any other Bridge Loan Documents and the First Amendment Notes, on the other hand, shall rank pari passu with one another, and (ii) each of the Initial Lenders and the First Amendment Lenders shall share pro rata in the proceeds of the Borrower's Collateral in accordance with a fraction, the denominator of which shall equal the unpaid principal balance of the Consolidated Bridge Loan, and the numerator of which shall equal, in the case of the Initial Lenders, the unpaid principal balance of the Initial Notes, and in the case of the First Amendment Lenders, the unpaid principal balance of the First Amendment Notes, all such amounts to be calculated as of (A) the Maturity Date, or (B) the date each Note becomes due and payable, whether by acceleration or otherwise, whichever date is sooner to occur."

SECTION II. CONDITIONS PRECEDENT.

This First Amendment shall become effective on the date when all of the following conditions, the fulfillment of each of which is a condition precedent to the effectiveness of this First Amendment, shall have occurred or shall have been waived in writing by Borrower and the Agent:

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1. First Amendment Closing Documents. Each Lender shall have received a duly executed original of, as is appropriate:

(i) this First Amendment;
(ii) its Note, if applicable;
(iii) its Warrant, if applicable;
(iv) the First Amendment Agency Agreement; and
(v) the First Amendment Waiver and Consent;

each conforming to the requirements hereof and executed as of the date of this First Amendment by a duly authorized representative of Borrower, the Lenders and the Agent, as the case may be.

2. Legal Opinion of Counsel to Borrower. The Agent shall have received an opinion, dated as of the First Amendment Closing Date, of St. John & Wayne, L.L.C., counsel to Borrower, which opinion shall be reasonably satisfactory to the Agent and its counsel.

3. Officer's Certificate. Borrower shall have received an Officer's Certificate from Borrower dated as of the First Amendment Closing Date, certifying as to the (i) Certificate of Incorporation of Borrower and all amendments thereto, (ii) accuracy and completeness of all By-Laws attached thereto, (iii) validity of the updated Certificates of Good Standing from the Secretaries of State of New York and Illinois with respect to Borrower, (iv) validity of the resolutions of the Board of Directors of Borrower approving the transactions relating to this First Amendment and each of the Bridge Loan Document to which it or they are a party and any other certificate or other document to be delivered pursuant thereto, together with evidence of the incumbency of such officer signing the same.

4. First Amendment Closing Fees. All expenses outstanding as of the date of this Agreement, including legal fees, relating to the Initial Consolidated Bridge Loan Agreement and the First Amendment and any and all documents relating thereto shall have been paid on or prior to the First Amendment Closing Date.

5. Updated Certificates of Good Standing. The Agent shall have received updated Certificates of Good Standing with respect to Borrower from the Secretaries of the State of New York and of Illinois.

6. Representations and Warranties. Upon the effectiveness of this First Amendment, all representations and warranties set forth in the Initial Consolidated Bridge Loan Agreement (except for such inducing representations and warranties that were only required to be true and correct as of a prior date), shall be true and correct in all material respects on and as of the effective date hereof, and no Default or Event of Default shall have occurred and be continuing and Agent shall have received a certificate of the President of Borrower to the same effect.

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7. Material Adverse Effect. No event or development shall have occurred since the date of delivery to the Agent of Borrower's most recent Form 10-Q and most recent financial statements which event or development has had or is reasonably likely to have a Material Adverse Effect.

8. President's Certificate. The Agent shall have received a certificate from the President of Borrower, as to the satisfaction of paragraphs 6, 7 and 10 of this Section II.

9. Additional Documents. All corporate and legal proceedings and all documents and instruments executed or delivered in connection with this First Amendment shall be satisfactory in form and substance to the Lenders, the Agent and their respective counsel, and the Lenders, the Agent and their respective counsel shall have received all information and copies of all documents which the Lenders, the Agent and their respective counsel may have requested in connection herewith and the matters contemplated hereunder, such documents, when requested by them, to be certified by the appropriate authorities.

10. Litigation. There shall be no action, suit or proceeding pending or threatened against Borrower before any court (including bankruptcy court), arbitrator or governmental or administrative body or agency that challenges or relates to the performance of this First Amendment or any other transactions contemplated herein.

11. Consents and Filings. Subject to (i) the receipt of shareholder approval to amend Borrower's Certificate of Incorporation to increase the authorized shares of Common Stock and the filing of such amendment with the Office of the Secretary of State of the State of New York, (ii) the receipt of the approval of the American Stock Exchange to the extent required under Section 713 of the American Company Stock Exchange Guide, to authorize the issuance of the Conversion Shares and the Warrant Shares in the event of a dilution adjustment to the Notes or the Warrants results in issuances of the Conversion Shares or the Warrant Shares at less than fair market value and (iii) the approval required under the Hart-Scott-Rodin Antitrust Improvements Act of 1976, as amended (the "HSR Act"); and except as otherwise obtained, no consent of any Person (including, without limitation, shareholders or creditors of such Borrower, as the case may be) other than the Majority Holders, the Agent shall have received such further agreements, consents, certificates, instruments and documents as may be necessary or proper in the reasonable opinion of the Agent and its counsel to carry out the provisions and purposes of this First Amendment.

12. No Liens. From the date of effectiveness of the Fourth Amendment to the date of effectiveness of this First Amendment, no Liens shall have arisen or been recorded against the Collateral.

9

SECTION III. REPRESENTATIONS AND WARRANTIES

Borrower hereby represents and warrants (which representations and warranties shall survive the execution and delivery hereof) to each Lender and the Agent that:

1. Authority. Borrower has the corporate power, authority and legal right to execute, deliver and perform this First Amendment, and the instruments, agreements, documents and transactions contemplated hereby, and has taken all actions necessary to authorize the execution, delivery and performance of this First Amendment, and the instruments, agreements, documents and transactions contemplated hereby.

2. Consents and Filings. Subject to (i) the receipt of shareholder approval to amend Borrower's Certificate of Incorporation to increase the authorized shares of Common Stock and the filing of such amendment with the Office of the Secretary of State of the State of New York, (ii) the receipt of the approval of the American Stock Exchange to the extent required under Section 713 of the American Company Stock Exchange Guide, to authorize the issuance of the Conversion Shares and the Warrant Shares in the event of a dilution adjustment to the Notes or the Warrants results in issuances of the Conversion Shares or the Warrant Shares at less than fair market value and (iii) the approval required under the Hart-Scott-Rodin Antitrust Improvements Act of 1976, as amended (the "HSR Act"); and except as otherwise obtained, no consent of any Person (including, without limitation, shareholders or creditors of such Borrower, as the case may be) other than the Majority Holders, no consent, permit, approval or authorization of, exemption by, notice or report to, or registration, filing or declaration with, any governmental authority is required in connection with the execution, delivery, performance, validity or enforceability of this First Amendment, and the instruments, agreements, documents and transactions contemplated hereby.

3. Due Execution. This First Amendment has been duly executed and delivered on behalf of Borrower, and constitutes the legal, valid and binding obligation of Borrower, enforceable in accordance with its terms.

4. No Default. Borrower is not in default in any material respect under any indenture, mortgage, deed of trust, agreement or other instrument to which it is a party or by which it may be bound. Except as otherwise described on Borrower's Form 10-Q for the quarter ended September 30, 1998, Borrower knows of no dispute regarding any such indenture, contract, lease, agreement, instrument or other commitment. Neither the execution and delivery of this First Amendment nor any Bridge Loan Document, nor the performance of the transactions herein or therein contemplated, nor compliance with the provisions hereof or thereof will
(i) violate any law or regulation, or (ii) result in or cause a violation by such Borrower of any order or decree of any court or government instrumentality, or (iii) conflict with, or result in the breach of, or constitute a default under, any indenture, mortgage, deed of trust, agreement or other instrument to which such Borrower is a party or by which it may be bound, or (iv) result in the creation or imposition of any lien, charge, or encumbrance upon any of the property of such Borrower, except in favor of the Agent, on behalf of

10

the Lenders, to secure the Obligations, or (v) violate any provision of the Certificate of Incorporation, By-Laws, or any capital stock provisions of such Borrower, except as otherwise provided in Section III(2) above.

5. No Event of Default. No Event of Default has occurred and is continuing.

6. Recitals. The recitals contained in this First Amendment are true and correct in all respects.

SECTION IV. GENERAL PROVISIONS

1. Except as herein expressly amended, the Consolidated Bridge Loan Agreement and all other agreements, documents, instruments and certificates executed in connection therewith, are ratified and confirmed in all respects and shall remain in full force and effect in accordance with their respective terms.

2. All references in the Bridge Loan Documents to the Consolidated Bridge Loan Agreement shall mean the Consolidated Bridge Loan Agreement as amended as of the effective date hereof, and as amended hereby and as hereafter amended, extended, modified, restated or supplemented from time to time. From and after the date hereof, all references in the Consolidated Bridge Loan Agreement to "this Agreement," "hereof," "herein," or similar terms, shall mean and refer to the Consolidated Bridge Loan Agreement as amended by this First Amendment.

3. The headings preceding the text of the sections and subsections of this First Amendment are used solely for convenience of reference and shall not affect the meaning, construction, or effect of the Agreement.

4. The validity and effect of this First Amendment shall be determined by reference to the substantive laws of the State of New York without regard to that State's principles of conflicts of laws, except to the extent that such other laws may govern the grant and perfection of a security interest in the Collateral.

5. This Amendment may be executed in any number of counterparts, each of which shall be an original and all of which together shall constitute but one and the same First Amendment.

[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in the state of New York, and delivered by their proper and duly authorized officers or managers as of the date set forth above.

    Borrower:       HALSEY DRUG CO., INC.


                    By:/s/
                       --------------------------------------------
                    Name:   Michael Reicher
                    Title:  Chief Executive Officer


The Lenders:        GALEN PARTNERS III, L.P.
                    By: Claudius, L.L.C., General Partner



                    By:/s/
                       --------------------------------------------
                    Name:   Bruce F. Wesson
                    Title:  Managing Member

GALEN PARTNERS INTERNATIONAL III, L.P.
By: Claudius, L.L.C., General Partner

By:/s/
   --------------------------------------------
Name:   Bruce F. Wesson
Title:  Managing Member

GALEN EMPLOYEE FUND III, L.P.
By: Wesson Enterprises, Inc.

By:/s/
   --------------------------------------------
Name:   Bruce F. Wesson
Title:  President

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/s/
-----------------------------------------------
Alan Smith



/s/
-----------------------------------------------
Michael Weisbrot


/s/
-----------------------------------------------
Susan Weisbrot


/s/
-----------------------------------------------
Greg Wood


/s/
-----------------------------------------------
Patrick Coyne

13

Exhibit 10.47

SECOND AMENDMENT
TO
AMENDED, RESTATED AND CONSOLIDATED
BRIDGE LOAN AGREEMENT

THIS SECOND AMENDMENT dated as of March 8, 1999 to Amended Restated and Consolidated Bridge Loan Agreement dated as of December 2, 1998 (as amended through the date hereof, the "Consolidated Bridge Loan Agreement") by and among HALSEY DRUG CO., INC., a New York corporation ("Borrower"), GALEN PARTNERS III, L.P. ("Galen", an "Initial Lender", a "Second Amendment Lender" or a "Lender") a Delaware limited partnership, GALEN PARTNERS INTERNATIONAL III, L.P. and GALEN EMPLOYEE FUND III, L.P., each a Delaware limited partnership (each an "Initial Lender", a "Second Amendment Lender", a "Lender", and collectively, with Galen, the "Galen Entities"), THOSE PERSONS WHOSE NAMES ARE SET FORTH ON THE SIGNATURE PAGE HERETO ( each a "Second Amendment Lender", a "Lender", and collectively, with the Galen Entities, the "Lenders") and GALEN, as agent for the Lenders (in such capacity, the "Agent") to the Amended, Restated and Consolidated Bridge Loan Agreement dated as of December 2, 1998 by and among Borrower, the Galen Entities and Michael Weisbrot and Susan Weisbrot (collectively, the "Weisbrots" or jointly and severally, an "Initial Lender", a "First Amendment Lender" or a "Lender" (the Weisbrots and the Galen Entities, each an "Initial Lender", a "Lender" and collectively, the "Initial Lenders"; as amended through the date hereof, the "Consolidated Bridge Loan Agreement"). Terms that are capitalized in this Second Amendment and not otherwise defined shall have the meaning ascribed to such terms in the Consolidated Bridge Loan Agreement.

WITNESSETH:

WHEREAS, the Borrower and the Initial Lenders have entered into the Consolidated Bridge Loan Agreement;

WHEREAS, the Borrower, the Initial Lenders and the First Amendment Lenders amended the Consolidated Bridge Loan Agreement pursuant to a certain First Amendment to Amended, Restated and Consolidated Bridge Loan Agreement dated as of December 7, 1998 (the "First Amendment") pursuant to which the First Amendment Lenders made an additional bridge loan of $283,000 (the "First Amendment Loan") available to the Borrower pursuant to the terms of the Consolidated Bridge Loan Agreement;

WHEREAS, Borrower has requested that the Galen Entities consider making an additional One Million Four Hundred Thousand Dollars ($1,400,000) bridge loan ("Second Amendment Bridge Loan") available to Borrower, the proceeds of which will be used by Borrower solely for Borrower's working capital purposes and other general business purposes, in each case pursuant to the Consolidated Bridge Loan Agreement and in accordance with the terms thereof and hereof.


NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the recipient and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

SECTION 1. AMENDMENTS

A. Amendment of Section 1. Definitions.

1. Section 1.1 of the Consolidated Bridge Loan Agreement entitled "General Definitions", is amended by the First Amendment:

(i) adding thereto, in the appropriate alphabetical order, each of the terms "Second Amendment", "Second Amendment Agency Agreement", "Second Amendment Bridge Loan", "Second Amendment Closing Date", "Second Amendment Closing Fees", "Second Amendment Commitment", "Second Amendment Consent and Waiver", "Second Amendment Conversion Price", "Second Amendment Lenders", "Second Amendment Loan", "Second Amendment Notes", "Second Amendment Warrants", "Note 9", "Note 10", "Note 11", and the definitions thereof, as hereinafter provided, and

(ii) deleting the definitions of the terms "Agency Agreements", "Agent", "Agreement", "Bridge Loan Documents", "Consents and Waivers", "Consolidated Bridge Loan", "Lenders", "Notes", "Obligations", "Warrants" and substituting the definitions set forth below in lieu thereof:

"Agency Agreements" mean the Initial Agency Agreement, the First Amendment Agency Agreement and the Second Amendment Agency Agreement.

"Agent" means Galen acting as agent to the Lenders pursuant to the Initial Agency Agreement, the First Amendment Agency Agreement and the Second Amendment Agency Agreement.

"Agreement" means the Initial Consolidated Bridge Loan Agreement, as amended by the First Amendment, as further amended by the Second Amendment, and as the same may hereafter be further amended, extended, modified, restated or supplemented from time to time.

"Bridge Loan Documents" means, collectively, the Consolidated Bridge Loan Agreement, the First Amendment, the Second Amendment, the Notes, the Warrants, the Agency Agreements, the Consents and Waivers, each of the Collateral Documents and all other documents, agreements, instruments, opinions and certificates now or hereafter executed and delivered in connection herewith or therewith, as modified, amended, extended, restated or supplemented from time to time.

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"Consents and Waivers" mean the Initial Consent and Waiver, the First Amendment Consent and Waiver and the Second Amendment Consent and Waiver.

"Consolidated Bridge Loan" has the meaning set forth in Section I(B)(2) hereto.

"Lenders" mean the Initial Lenders, the First Amendment Lenders and the Second Amendment Lenders.

"Note 9" means a certain promissory note dated as of March 8, 1999 payable by Borrower to the order of Galen in the amount of $1,278,992.

"Note 10" means a certain promissory note dated as of March 8, 1999 payable by Borrower to the order of Galen Partners International III, L.P. in the amount of $115,771.

"Note 11" means a certain promissory note dated as of March 8, 1999 payable by Borrower to the order of Galen Employee Fund III, L.P. in the amount of $5,237.

"Notes" means Note 1, Note 2, Note 3, Note 4, Note 5, Note 6, Note 7, Note 8, Note 9, Note 10 and Note 11 or any one of the Notes (individually a "Note").

"Obligations" means the unpaid principal and interest hereunder, expenses and all other obligations and liabilities of Borrower to the Lenders under this Agreement, the Notes or any other Bridge Loan Document, and includes, but is not limited to, any and all indebtedness of Borrower to the Lenders, whether now existing or hereafter incurred, of every kind and character, direct or indirect, and whether such indebtedness is from time to time reduced and thereafter increased, or entirely extinguished and thereafter reincurred, including, without limitation: (a) indebtedness not yet outstanding, but contracted for, or with respect to which any other commitment by the Lenders exists; (b) all interest provided in any instrument, document, or agreement (including this Agreement) which accrues on any indebtedness until payment of such indebtedness in full; and (c) any moneys payable as hereinafter provided.

"Second Amendment" means the Second Amendment to the Initial Consolidated Bridge Loan Agreement dated as of March 8, 1999 by and among Borrower, the Lenders and Agent, as the same may hereafter be further amended, extended, modified, restated or supplemented from time to time.

"Second Amendment Agency Agreement" means the Agency Agreement by and among the Second Amendment Lenders dated the date hereof and entered into simultaneously herewith, substantially in the Form of Exhibit E attached hereto.

"Second Amendment Bridge Loan" has the meaning set forth in the Recitals to this Agreement.

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"Second Amendment Closing Date" means the date upon which the last of the events, the fulfillment of each of which is condition precedent to the effectiveness of this Second Amendment, as set forth in Section II of this Second Amendment, shall have occurred.

"Second Amendment Closing Fees" means the expenses as set forth in
Section II(4) of this Second Amendment.

"Second Amendment Commitment" means the commitment of each Second Amendment Lender to fund the dollar amount of its share of the Second Amendment Loan in the amount set forth opposite such Lender's name on Exhibit A, a copy of which is attached hereto and made a part hereof.

"Second Amendment Consent and Waiver" means a consent and waiver of lien, indebtedness and registration rights restrictions executed by the Majority Holders in connection with this Second Amendment dated the date hereof and executed simultaneously herewith, substantially in the form of Exhibit D attached hereto.

"Second Amendment Conversion Price" means $1.1969.

"Second Amendment Lenders" has the meaning set forth in the Section entitled "Pari Passu and Pro Rata Relationship of the Initial Lenders to the First Amendment Lenders and to the Second Amendment Lenders" (Section I(B)(4) hereof).

"Second Amendment Notes" mean Note 9, Note 10, and Note 11.

"Second Amendment Warrants" means the warrants to purchase 66,887 shares, in the aggregate, of the Common Stock, dated the date hereof and issued by Borrower to each of the Second Amendment Lenders, substantially in the form of Exhibit C attached hereto.

"Warrants" mean the Initial Warrants, and the First Amendment Warrants and the Second Amendment Warrants.

B. Amendment of Section 2. Terms of the Consolidated Bridge Loan.

1. Section 2.1 of the Agreement is amended in its entirety to read as follows:

"2.1 Commitment. Subject to the terms and conditions of this Agreement, (i) each Lender hereby agrees to amend and restate the original Notes and the original Bridge Loan Agreement; (ii) each of the Galen entities hereby agrees to fund the amount of its Additional Bridge Loan Commitment; (iii) each Initial Lender hereby agrees to consolidate the Original Bridge Loan, together with all interest accrued thereon, with the Additional Bridge Loan; (iv) each First Amendment Lender hereby agrees to fund the amount of its First Amendment Commitment; and (v)

4

each First Amendment Lender hereby agrees to fund the amount of its Second Amendment Commitment."

2. Section 2.2 of the Agreement is amended in its entirety to read as follows:

"2.2 Initial Consolidated Bridge Loan; Consolidated Bridge Loan.

(a) Initial Consolidated Bridge Loan. Borrower warrants, represents and confirms that, as of the Initial Closing Date,
(i) the aggregate outstanding principal balance of the Original Bridge Loan equals $4,500,000, (ii) the aggregate accrued interest on such principal balance equals $71,111 and
(iii) the aggregate outstanding principal balance of the Additional Bridge Loan equals $3,250,000. Borrower and Lenders agree that effective on the Initial Closing Date, upon the consolidation of the outstanding principal balances of the Original Bridge Loan and the Additional Bridge Loan, and the addition to principal of the accrued interest on the Original Bridge Loan, Lenders shall be deemed to have made a single loan to Borrower in the aggregate principal amount of $7,821,111 (the "Initial Consolidated Bridge Loan").

(b) Consolidated Bridge Loan. Borrower warrants, represents and confirms that, as of the First Amendment Closing Date (i) the aggregate outstanding principal balance of the Original Bridge Loan equals $4,500,000, (ii) the aggregate accrued interest on such principal balance equals $71,111, (iii) the aggregate outstanding principal balance of the Additional Bridge Loan equals $3,250,000 and (iv) the aggregate outstanding principal balance of the First Amendment Loan equals $283,000. Borrower further warrants, represents and confirms that, as of the Second Amendment Closing Date, the aggregate outstanding principal balance of the Second Amendment Loan equals $1,400,000. Borrower and the Lenders agree that effective on the Second Amendment Closing Date, the total amount of funds advanced by the Lenders equals, in the aggregate principal amount $9,504,111 (the "Consolidated Bridge Loan")."

3. Section 2.3(a) and (b) of the Agreement is amended in its entirety to read as follows:

"2.3 Amended, Restated and Consolidated Notes.

(a) The Amount. The Initial Consolidated Bridge Loan is evidenced by the Initial Notes, the First Amendment Loan is evidenced by the First Amendment Notes and the Second Amendment Loan is evidenced by the Second Amendment Notes.

(b) General Terms. The Notes are 10% Convertible Senior Secured Notes due on May 30, 1999. Each Note is convertible, in whole or

5

in part, from time to time, into a number of shares of Common Stock, initially at the rate set forth in the Notes. For purposes of this Agreement, the term "Conversion Shares" shall mean the shares of Common Stock which may be issued upon conversion of all or a portion of the principal amounts of the Notes."

4. Section 2.4 of the Agreement is amended in its entirety to read as follows:

"2.4 Warrants. Subject to the terms of Initial Consolidated Bridge Loan Agreement and the terms of the Initial Warrants, Borrower has issued Initial Warrants to purchase in the aggregate, 689,722 shares of the Common Stock, initially, at a price per share equal to Initial Conversion Price, in the amounts set forth opposite each Initial Lender's name on Exhibit A. Subject to the terms of the First Amendment and the terms of the First Amendment Warrants, Borrower has issued Warrants to purchase in the aggregate, 28,300 shares of the Common Stock, initially, at a price per share equal to the First Amendment Conversion Price. Subject to the terms of this Second Amendment and the terms of the Second Amendment Warrants substantially in the form of Exhibit C, Borrower will issue warrants to purchase in the aggregate, 66,887 shares of the Common Stock, initially, at a price per share equal to the Second Amendment Conversion Price. The Second Amendment Warrants shall be issued to each of the Second Amendment Lenders in the amounts set forth opposite each Second Amendment Lender's name on Exhibit A. For purposes of this Agreement, the term "Warrant Shares", shall mean the shares of Common Stock that may be issued from time to time pursuant to the exercise of the Warrants."

5. Section 2.10 of the Agreement is amended in its entirety to read as follows:

"2.10.Pari Passu and Pro Rata Relationship of the Initial Lenders to the First Amendment Lenders and to the Second Amendment Lenders. Until such time as the unpaid principal balance of the Initial Notes, in the original aggregate principal amount of $7,821,111, the First Amendment Notes, in the original aggregate principal amount of $283,000, and the Second Amendment Notes, in the original principal amount of $1,400,000 shall have been paid in full, or in a manner otherwise satisfactory to the Agent, (i) the Initial Lenders' Lien on the Borrower's Collateral with respect to the Obligations of Borrower to the Initial Lenders under this Agreement, any other Bridge Loan Documents and the Initial Notes, the Obligations of Borrower to the First Amendment Lenders under this Agreement, any other Bridge Loan Documents and the First Amendment Notes, and the Obligations of Borrower to the Second Amendment Lenders under this Agreement, any other Bridge Loan

6

Documents and the Second Amendment Notes, shall rank pari passu with one another, and (ii) each of the Initial Lenders, the First Amendment Lenders and the Second Amendment Lenders shall share pro rata in the proceeds of the Borrower's Collateral in accordance with a fraction, the denominator of which shall equal the unpaid principal balance of the Consolidated Bridge Loan, and the numerator of which shall equal, in the case of the Initial Lenders, the unpaid principal balance of the Initial Notes, in the case of the First Amendment Lenders, the unpaid principal balance of the First Amendment Notes, and in the case of the Second Amendment Lenders, the unpaid principal amount of the Second Amendment Notes, all such amounts to be calculated as of (A) the Maturity Date, or (B) the date each Note becomes due and payable, whether by acceleration or otherwise, whichever date is sooner to occur."

SECTION II. CONDITIONS PRECEDENT.

This Second Amendment shall become effective on the date when all of the following conditions, the fulfillment of each of which is a condition precedent to the effectiveness of this Second Amendment, shall have occurred or shall have been waived in writing by Borrower and the Agent:

1. Second Amendment Closing Documents. Each Lender shall have received a duly executed original of, as is appropriate:

(i) this Second Amendment;
(ii) its Note, if applicable;
(iii) its Warrant, if applicable;
(iv) the Second Amendment Agency Agreement; and
(v) the Second Amendment Waiver and Consent;

each conforming to the requirements hereof and executed as of the date of this Second Amendment by a duly authorized representative of Borrower, the Lenders and the Agent, as the case may be.

2. Legal Opinion of Counsel to Borrower. The Agent shall have received an opinion, dated as of the Second Amendment Closing Date, of St. John & Wayne, L.L.C., counsel to Borrower, which opinion shall be reasonably satisfactory to the Agent and its counsel.

3. Officer's Certificate. Borrower shall have received an Officer's Certificate from Borrower dated as of the Second Amendment Closing Date, certifying as to the (i) Certificate of Incorporation of Borrower and all amendments thereto, (ii) accuracy and completeness of all By-Laws attached thereto, (iii) validity of the updated Certificates of Good Standing from the Secretaries of State of

7

New York and Illinois with respect to Borrower, (iv) validity of the resolutions of the Board of Directors of Borrower approving the transactions relating to this Second Amendment and each of the Bridge Loan Document to which it or they are a party and any other certificate or other document to be delivered pursuant thereto, together with evidence of the incumbency of such officer signing the same.

4. Second Amendment Closing Fees. All expenses outstanding as of the date of this Agreement, including legal fees, relating to the Initial Consolidated Bridge Loan Agreement, and the Second Amendment and any and all documents relating thereto shall have been paid on or prior to the Second Amendment Closing Date.

5. Updated Certificates of Good Standing. The Agent shall have received updated Certificates of Good Standing with respect to Borrower from the Secretaries of the State of New York and of Illinois.

6. Representations and Warranties. Upon the effectiveness of this Second Amendment, all representations and warranties set forth in the First Amendment (except for such inducing representations and warranties that were only required to be true and correct as of a prior date), shall be true and correct in all material respects on and as of the effective date hereof, and no Default or Event of Default shall have occurred and be continuing and Agent shall have received a certificate of the President of Borrower to the same effect.

7. Material Adverse Effect. No event or development shall have occurred since the date of delivery to the Agent of Borrower's most recent Form 10-Q and most recent financial statements which event or development has had or is reasonably likely to have a Material Adverse Effect.

8. President's Certificate. The Agent shall have received a certificate from the President of Borrower, as to the satisfaction of paragraphs 6, 7 and 10 of this Section II.

9. Additional Documents. All corporate and legal proceedings and all documents and instruments executed or delivered in connection with this Second Amendment shall be satisfactory in form and substance to the Lenders, the Agent and their respective counsel, and the Lenders, the Agent and their respective counsel shall have received all information and copies of all documents which the Lenders, the Agent and their respective counsel may have requested in connection herewith and the matters contemplated hereunder, such documents, when requested by them, to be certified by the appropriate authorities.

10. Litigation. There shall be no action, suit or proceeding pending or threatened against Borrower before any court (including bankruptcy court), arbitrator or governmental or administrative body or agency that challenges or relates to the performance of this Second Amendment or any other transactions contemplated herein.

8

11. Consents and Filings. Subject to (i) the receipt of shareholder approval to amend Borrower's Certificate of Incorporation to increase the authorized shares of Common Stock and the filing of such amendment with the Office of the Secretary of State of the State of New York, (ii) the receipt of the approval of the American Stock Exchange to the extent required under Section 713 of the American Company Stock Exchange Guide, to authorize the issuance of the Conversion Shares and the Warrant Shares in the event of a dilution adjustment to the Notes or the Warrants results in issuances of the Conversion Shares or the Warrant Shares at less than fair market value and (iii) the approval required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"); and except as otherwise obtained, no consent of any Person (including, without limitation, shareholders or creditors of such Borrower, as the case may be) other than the Majority Holders, the Agent shall have received such further agreements, consents, certificates, instruments and documents as may be necessary or proper in the reasonable opinion of the Agent and its counsel to carry out the provisions and purposes of this Second Amendment.

12. No Liens. From the date of effectiveness of the First Amendment to the date of effectiveness of this Second Amendment, no Liens shall have arisen or been recorded against the Collateral.

SECTION III. REPRESENTATIONS AND WARRANTIES

Borrower hereby represents and warrants (which representations and warranties shall survive the execution and delivery hereof) to each Lender and the Agent that:

1. Authority. Borrower has the corporate power, authority and legal right to execute, deliver and perform this Second Amendment, and the instruments, agreements, documents and transactions contemplated hereby, and has taken all actions necessary to authorize the execution, delivery and performance of this Second Amendment, and the instruments, agreements, documents and transactions contemplated hereby.

2. Consents and Filings. Subject to (i) the receipt of shareholder approval to amend Borrower's Certificate of Incorporation to increase the authorized shares of Common Stock and the filing of such amendment with the Office of the Secretary of State of the State of New York, (ii) the receipt of the approval of the American Stock Exchange to the extent required under Section 713 of the American Company Stock Exchange Guide, to authorize the issuance of the Conversion Shares and the Warrant Shares in the event of a dilution adjustment to the Notes or the Warrants results in issuances of the Conversion Shares or the Warrant Shares at less than fair market value and (iii) the approval required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"); and except as otherwise obtained, no consent of any Person (including, without limitation, shareholders or creditors of such Borrower, as the case may be) other than the Majority Holders, no consent, permit, approval or authorization of, exemption by, notice or report to, or registration, filing or declaration with, any governmental authority is required in connection with the

9

execution, delivery, performance, validity or enforceability of this First Amendment, and the instruments, agreements, documents and transactions contemplated hereby.

3. Due Execution. This Second Amendment has been duly executed and delivered on behalf of Borrower, and constitutes the legal, valid and binding obligation of Borrower, enforceable in accordance with its terms.

4. No Default. Borrower is not in default in any material respect under any indenture, mortgage, deed of trust, agreement or other instrument to which it is a party or by which it may be bound. Except as otherwise described on Borrower's Form 10-Q for the quarter ended September 30, 1998, Borrower knows of no dispute regarding any such indenture, contract, lease, agreement, instrument or other commitment. Neither the execution and delivery of this Second Amendment nor any Bridge Loan Document, nor the performance of the transactions herein or therein contemplated, nor compliance with the provisions hereof or thereof will
(i) violate any law or regulation, or (ii) result in or cause a violation by such Borrower of any order or decree of any court or government instrumentality, or (iii) conflict with, or result in the breach of, or constitute a default under, any indenture, mortgage, deed of trust, agreement or other instrument to which such Borrower is a party or by which it may be bound, or (iv) result in the creation or imposition of any lien, charge, or encumbrance upon any of the property of such Borrower, except in favor of the Agent, on behalf of the Lenders, to secure the Obligations, or (v) violate any provision of the Certificate of Incorporation, By-Laws, or any capital stock provisions of such Borrower, except as otherwise provided in Section III(2) above.

5. No Event of Default. No Event of Default has occurred and is continuing.

6. Recitals. The recitals contained in this Second Amendment are true and correct in all respects.

SECTION IV. GENERAL PROVISIONS

1. Except as herein expressly amended, the Consolidated Bridge Loan Agreement and all other agreements, documents, instruments and certificates executed in connection therewith, are ratified and confirmed in all respects and shall remain in full force and effect in accordance with their respective terms.

2. All references in the Bridge Loan Documents to the Consolidated Bridge Loan Agreement shall mean the Consolidated Bridge Loan Agreement as amended as of the effective date hereof, and as amended hereby and as hereafter amended, extended, modified, restated or supplemented from time to time. From and after the date hereof, all references in the Consolidated Bridge Loan Agreement to "this Agreement," "hereof," "herein," or similar terms, shall mean and refer to the Consolidated Bridge Loan Agreement as amended by the First Amendment and as further amended by this Second Amendment.

10

3. The headings preceding the text of the sections and subsections of this Second Amendment are used solely for convenience of reference and shall not affect the meaning, construction, or effect of the Agreement.

4. The validity and effect of this Second Amendment shall be determined by reference to the substantive laws of the State of New York without regard to that State's principles of conflicts of laws, except to the extent that such other laws may govern the grant and perfection of a security interest in the Collateral.

5. This Amendment may be executed in any number of counterparts, each of which shall be an original and all of which together shall constitute but one and the same Second Amendment.

[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]

11

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed in the state of New York, and delivered by their proper and duly authorized officers or managers as of the date set forth above.

    Borrower:       HALSEY DRUG CO., INC.


                    By:/s/
                       --------------------------------------------
                    Name:   Michael Reicher
                    Title:  Chief Executive Officer


The Lenders:        GALEN PARTNERS III, L.P.
                    By: Claudius, L.L.C., General Partner



                    By:/s/
                       --------------------------------------------
                    Name:   Bruce F. Wesson
                    Title:  Managing Member

GALEN PARTNERS INTERNATIONAL III, L.P.
By: Claudius, L.L.C., General Partner

By:/s/
   --------------------------------------------
Name:   Bruce F. Wesson
Title:  Managing Member

GALEN EMPLOYEE FUND III, L.P.
By: Wesson Enterprises, Inc.

By:/s/
   --------------------------------------------
Name:   Bruce F. Wesson
Title:  President

12

/s/
-----------------------------------------------
Alan Smith


/s/
-----------------------------------------------
Michael Weisbrot


/s/
-----------------------------------------------
Susan Weisbrot


/s/
-----------------------------------------------
Greg Wood


/s/
-----------------------------------------------
Patrick Coyne

13

Exhibit 10.48

[Form of 10% Convertible Secured Note due May 30, 1999]

THIS CONVERTIBLE SENIOR SECURED NOTE AND THE COMMON STOCK ISSUABLE UPON CONVERSION HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "ACT") NOR UNDER ANY STATE SECURITIES LAW AND MAY NOT BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR OTHERWISE TRANSFERRED UNTIL (1) A REGISTRATION STATEMENT WITH RESPECT THERETO IS EFFECTIVE UNDER THE ACT AND ANY APPLICABLE STATE SECURITIES LAW OR (2) THE COMPANY RECEIVES AN OPINION OF COUNSEL TO THE COMPANY OR OTHER COUNSEL TO THE HOLDER OF SUCH NOTE REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH NOTE AND/OR COMMON STOCK MAY BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR APPLICABLE STATE SECURITIES LAWS.

HALSEY DRUG CO., INC.
Amended, Restated and Consolidated
10% Convertible Senior Secured Note
Due May 30, 1999

$[___________] No. [____] December 2, 1998

HALSEY DRUG CO., INC., a corporation organized under the laws of the State of New York (the "Company"), for value received, hereby promises to pay to the order of [_______________________] ("________"), a Delaware limited partnership, with its principal place of business at 610 Fifth Avenue, 5th Floor, New York, New York 10020 or registered assigns (the "Payee" or "Holder") upon due presentation and surrender of this Note, on May 30, 1999 (the "Maturity Date"), the principal amount of [_____________________________] ($__________________) and accrued interest thereon as hereinafter provided.

This Note was issued by the Company pursuant a certain Amended, Restated and Consolidated Bridge Loan Agreement dated the date hereof among the Company and certain persons, including the Payee, (together with the Schedules and Exhibits thereto, the "Agreement") relating to the issuance of 10% Convertible Senior Secured Notes maturing May 30, 1999 (the "Notes") in the original aggregate principal amount of $8,571,111. The holders of such Notes are referred to hereinafter as the "Holders". The Payee is entitled to the benefits of the Agreement.


Reference is made to the Agreement with respect to certain additional rights of the Payee and obligations of the Company not set forth herein. Terms that are capitalized in this Note, but not otherwise defined, shall have the meanings ascribed to them in the Agreement.

This Note evidences the amendment and restatement, in its entirety, of Galen's share of the Original Bridge Loan, and, the consolidation of Galen's Share of the Original Bridge Loan with Galen's share of the Additional Bridge Loan. This Note does not create a novation of, nor does this Note, in any manner, diminish or extinguish the unpaid principal balance of, or the accrued interest on, the Company's indebtedness to Galen, as originally set forth in the Original Bridge Loan Agreement, and, as evidenced by the Original Notes. Such unpaid balance of, and such accrued interest on such indebtedness continues to be due and owing by the Company to Galen, as described herein, and the Company hereby reaffirms and confirms same.

ARTICLE I

PAYMENT OF PRINCIPAL AND INTEREST; METHOD OF PAYMENT

1.1 Payment of Principal and Interest. Payment of the principal and accrued interest on the principal of this Note shall be made in such coin or currency of the United States of America as at the time of payment shall be legal tender for the payment of public and private debts. Interest (computed on the basis of a 360-day year of twelve 30-day months) on the unpaid portion of said principal amount from time to time outstanding shall be paid by the Company at the rate of ten percent (10%) per annum (the "Stated Interest Rate") payable to the Payee on the Maturity Date.

1.2 Method of Payment. Both principal hereof and interest thereon are payable to the Holder at the address of the Holder above, or such other name or address as the Holder shall designate from time to time by written notice to the Company. The Company will pay or cause to be paid all sums becoming due hereon for principal and interest by check sent to the Holder's above address or to such other address as the Holder may designate for such purpose from time to time by written notice to the Company, without any requirement for the presentation of this Note or making any notation thereon, except that the Holder hereof agrees that payment of the final amount due shall be made only upon surrender of this Note to the Company for cancellation. Prior to any sale or other disposition of this instrument, the Holder hereof agrees to endorse hereon the amount of principal paid hereon and the last date to which interest has been paid hereon and to notify the Company of the name and address of the transferee.

1.3 Late Payments. In the event any payment of principal or interest or both shall remain unpaid for a period of ten (10) days or more, a late charge equivalent to five (5%) percent of each installment shall be charged. Interest on the indebtedness evidenced by this Note after default, or maturity accelerated or otherwise, shall be due and payable at the rate of twelve (12%) percent per annum, subject to the limitations of applicable law.

1.4 Miscellaneous. If this Note or any installment hereof becomes due and payable on a Saturday, Sunday or public holiday under the laws of the State of New York, the due date hereof shall be extended to the next succeeding full business day and interest shall be payable at the rate of


ten (10%) percent per annum during such extension. All payments received by the Holder shall be applied first to the payment of all accrued interest payable hereunder.

ARTICLE II

SECURITY

2.1 The payment and performance of the Obligations of the Company under this Note are secured by liens on and security interests in and to the Collateral granted by the Company to the Lenders pursuant to a certain Amended and Restated Security Agreement dated the date hereof, and executed simultaneously herewith.

ARTICLE III

CONVERSION

3.1 Conversion at Option of Holder. At any time and from time to time, until the payment in full of the outstanding principal and the accrued interest on the principal of this Note, this Note and the accrued interest thereon is convertible, in whole or in part, at the Holder's option into shares of Common Stock upon surrender of this Note, at the office of the Company, accompanied by a written notice of conversion in form reasonably satisfactory to the Company duly executed by the registered Holder or its duly authorized attorney. The outstanding principal balance of this Note is convertible into shares of Common Stock initially at a price per share of Common Stock equal to $1.3688 per share. Interest shall accrue to and include the day prior to the date of conversion, and, if any accrued interest on the principal of this Note is not converted into Common Stock , the such accrued interest shall be paid on the last day of the month during which any conversion rights are exercised. If the Holder elects to convert such accrued interest, then the conversion price is to be based on the average closing price of the Common Stock for the twenty (20) days immediately preceding the payment date of the interest as reported by the American Stock Exchange. Instead of issuing fractional shares, or a scrip representing fractional shares, an adjustment in cash will be made for any fraction of a share that would otherwise have been issuable upon the conversion of any portion of this Note. The Conversion Price is subject to adjustment as provided in Sections 3.5 and 3.7 hereof. As soon as practicable after conversion and upon the Holder's compliance with the conversion procedure described in
Section 3.3 below, the Company shall deliver a certificate for the number of full shares of Common Stock issuable upon conversion and a check for any fractional share and, if the Note is converted in part, a new Note in the principal amount equal to the principal balance remaining under this Note after giving effect to such partial conversion.

3.2 [INTENTIONALLY LEFT BLANK]

3.3 Registration of Transfer; Conversion Procedure. The Company shall maintain books for the transfer and registration of the Notes. Upon the transfer of any Note in accordance with the provisions of the Agreement, the Company shall issue and register the Note in the names of the new holders. The Notes shall be signed manually by the Chairman, Chief Executive Officer, President or any Vice President and the Secretary or Assistant Secretary of the Company. The Company shall convert, from time to time, any outstanding Notes upon the books to be maintained by the Company for such purpose upon surrender thereof for conversion properly endorsed and, in the case of a


conversion pursuant to Section 3.1 hereof, accompanied by a properly completed and executed Conversion Notice attached hereto as Attachment II. Subject to the terms of this Note, upon surrender of this Note the Company shall issue and deliver with all reasonable dispatch to or upon the written order of the Holder of such Note and in such name or names as such Holder may designate, a certificate or certificates for the number of full shares of Common Stock due to such Holder upon the conversion of this Note. Such certificate or certificates shall be deemed to have been issued and any person so designated to be named therein shall be deemed to have become the Holder of record of such Shares as of the date of the surrender of this Note; provided, however, that if, at the date of surrender the transfer books of the Common Stock shall be closed, the certificates for the shares shall be issuable as of the date on which such books shall be opened and until such date the Company shall be under no duty to deliver any certificate for such shares; provided, further, however, that such transfer books, unless otherwise required by law or by applicable rule of any national securities exchange, shall not be closed at any one time for a period longer than twenty (20) days.

3.4 Company to Provide Common Stock. In accordance with the provisions of Section 6(1)(m) of the Agreement, the Company covenants to seek the approval of its shareholders to amend its Certificate of Incorporation to increase its authorized shares from 40,000,000 to 75,000,000 shares of Common Stock. Promptly upon receipt of shareholder approval to amend its certificate of incorporation to increase its authorized shares, the Company shall reserve out of its authorized but unissued common stock a sufficient number of shares to permit the conversion of the Notes in full. The shares of Common Stock which may be issued upon the conversion of the Notes shall be fully paid and non-assessable and free of preemptive rights. The Company will endeavor to comply with all securities laws regulating the offer and delivery of the Shares upon conversion of the Notes and will endeavor to list such shares on each national securities exchange upon which the Common Stock is listed.

3.5 Dividends; Reclassifications, etc. At any time before the earlier of (i) the exercise of conversion rights hereunder or (ii) the Maturity Date, if the Company: (i) declares or pays to the holders of the Common Stock a dividend payable in any kind of shares of capital stock of the Company; or (ii) changes or divides or otherwise reclassifies its Common Stock into the same or a different number of shares with or without par value, or in shares of any class or classes; or (iii) transfers its property as an entirety or substantially as an entirety to any other company or entity; or (iv) makes any distribution of its assets to holders of its Common Stock as a liquidation or partial liquidation dividend or by way of return of capital; then, upon exercising its conversion rights, the Holder thereof shall receive, in addition to or in substitution for the shares of Common Stock to which it would have otherwise been entitled upon such exercise: (i) such additional shares of stock or scrip of the Company; (ii) such reclassified shares of stock of the Company, or (iii) such shares of the securities or property of the Company resulting from transfer, or (iv) such assets of the Company, which it would have been entitled to receive had it exercised these conversion rights prior to the happening of any of the foregoing events.

3.6 Notice to Holder. If, at any time while this Note is outstanding, the Company shall pay any dividend payable in cash or in shares of Common Stock, shall offer to the holders of its Common Stock for subscription or purchase by them any shares of stock of any class or any other rights, shall enter into an agreement to merge or consolidate with another corporation, shall propose any capital reorganization or reclassification of the capital stock of the Company, including any


subdivision or combination of its outstanding shares of Common Stock or there shall be contemplated a voluntary or involuntary dissolution, liquidation or winding up of the Company, the Company shall cause notice thereof to be mailed to the registered Holder of this Note at its address appearing on the registration books of the Company, at least thirty (30) days before the record date as of which holders of Common Stock shall participate in such dividend, distribution or subscription or other rights or at least thirty (30) days prior to the effective date of the merger, consolidation, reorganization, reclassification or dissolution.

3.7 Adjustments to Conversion Price. In order to prevent dilution of the conversion rights granted hereunder, the Conversion Price shall be subject to adjustment from time to time in accordance with this Section 3.7. The Conversion Price in effect at the time of the exercise of conversion rights hereunder, shall be subject to adjustment, or further adjustment, from time to time as follows:

(a) If at any time after the date of issuance hereof and prior to the payment in full of the principal and the accrued interest on the principal of this Note, the Company shall grant or issue any shares of Common Stock, or grant or issue any rights or options for the purchase of, or stock or other securities convertible into, Common Stock (such convertible stock or securities being herein collectively referred to as "Convertible Securities") or any combination whatsoever of Common Stock or Convertible Securities, other than:

(i) shares issued in a transaction described in subsection (b) of this Section 3.7; or

(ii) shares issued, subdivided or combined in transactions described in Section 3.5 if and to the extent that the number of shares of Common Stock received upon conversion of this Note shall have been previously adjusted pursuant to Section 3.5 as a result of such issuance, subdivision or combination of such securities;

for a consideration per share which is less than the Conversion Price in effect immediately prior to such issuance or sale, then the Conversion Price, and thereafter upon each issuance or sale for a consideration per share which is less than the Conversion Price in effect immediately prior to such issuance or sale, the Conversion Price shall, simultaneously with such issuance or sale, be adjusted, so that the Conversion Price immediately prior to such issuance or sale, shall be reduced to the consideration received by the Company for each share of Common Stock in such issuance.

Upon each adjustment of the Conversion Price pursuant to this subsection (a), the total number of shares of Common Stock into which this Note shall be convertible shall be such number of shares (calculated to the nearest tenth) purchasable at the Applicable Conversion Price multiplied by a fraction, the numerator of which shall be the Applicable Conversion Price in effect immediately prior to such adjustment and the denominator of which shall be the conversion price in effect immediately after such adjustment.

(b) Anything in this Section 3.7 to the contrary notwithstanding, no adjustment in the Conversion Price shall be made in connection with:


(i) the grant, issuance or exercise of any Convertible Securities pursuant to the Company's qualified or non-qualified Employee Stock Option Plans or any other bona fide employee benefit plan or incentive arrangement, adopted or approved by the Company's Board of Directors and approved by the Company's shareholders, as may be amended from time to time, or under any other bona fide employee benefit plan hereafter adopted by the Company's Board of Directors; or

(ii) the grant, issuance or exercise of any Convertible Securities in connection with the hire or retention of any officer, director or key employee of the Company, provided such grant is approved by the Company's Board of Directors; or

(iii) the issuance of any shares of Common Stock pursuant to the grant or exercise of Convertible Securities outstanding as of December 2, 1998 (exclusive of any subsequent amendments thereto).

(c) For the purpose of subsection 3.7(a), the following provisions shall also be applied:

(i) In case of the issuance or sale of additional shares of Common Stock for cash, the consideration received by the Company therefor shall be deemed to be the amount of cash received by the Company for such shares, before deducting therefrom any commissions, compensation or other expenses paid or incurred by the Company for any underwriting of, or otherwise in connection with, the issuance or sale of such shares.

(ii) In the case of the issuance of Convertible Securities, the consideration received by the Company therefor shall be deemed to be the amount of cash, if any, received by the Company for the issuance of such rights or options, plus the minimum amounts of cash and fair value of other consideration, if any, payable to the Company upon the exercise of such rights or options or payable to the Company upon conversion of such Convertible Securities.

(iii) In the case of the issuance of shares of Common Stock or Convertible Securities for a consideration in whole or in part, other than cash, the consideration other than cash shall be deemed to be the fair market value thereof as reasonably determined in good faith by the Board of Directors of the Company (irrespective of accounting treatment thereof); provided, however, that if such consideration consists of the cancellation of debt issued by the Company, the consideration shall be deemed to be the amount the Company received upon issuance of such debt (gross proceeds) plus accrued interest and, in the case of original issue discount or zero coupon indebtedness, accrued value to the date of such cancellation, but not including any premium or discount at which the debt may then be trading or which might otherwise be appropriate for such class of debt.

(iv) In case of the issuance of additional shares of Common Stock upon the conversion or exchange of any obligations (other than Convertible Securities), the amount of the consideration received by the Company for such Common Stock shall be deemed to be the consideration received by the Company for such obligations or shares so converted or exchanged, before deducting from such consideration so received by the Company any expenses or commissions


or compensation incurred or paid by the Company for any underwriting of, or otherwise in connection with, the issuance or sale of such obligations or shares, plus any consideration received by the Company in connection with such conversion or exchange other than a payment in adjustment of interest and dividends. If obligations or shares of the same class or series of a class as the obligations or shares so converted or exchanged have been originally issued for different amounts of consideration, then the amount of consideration received by the Company upon the original issuance of each of the obligations or shares so converted or exchange shall be deemed to be the average amount of the consideration received by the Company upon the original issuance of all such obligations or shares. The amount of consideration received by the Company upon the original issuance of the obligations or shares so converted or exchanged and the amount of the consideration, if any, other than such obligations or shares, received by the Company upon such conversion or exchange shall be determined in the same manner as provided in paragraphs (i) and (ii) above with respect to the consideration received by the Company in case of the issuance of additional shares of Common Stock or Convertible Securities.

(d) Upon any adjustment of any Conversion Price, then and in each such case the Company shall promptly deliver a notice to the registered Holder of this Note, which notice shall state the Conversion Price resulting from such adjustment, setting forth in reasonable detail the method of calculation and the facts upon which such calculation is based.

3.8 Reorganization of the Company. If the Company is a party to a merger or other transaction which reclassifies or changes its outstanding Common Stock, upon consummation of such transaction this Note shall automatically become convertible into the kind and amount of securities, cash or other assets which the Holder of this Note would have owned immediately after such transaction if the Holder had converted this Note at the Conversion Price in effect immediately before the effective date of the transaction. Concurrently with the consummation of such transaction, the person obligated to issue securities or deliver cash or other assets upon conversion of this Note shall execute and deliver to the Holder a supplemental Note so providing and further providing for adjustments which shall be as nearly equivalent as may be practical to the adjustments provided in this Article 3. The successor Company shall mail to the Holder a notice describing the supplemental Note.

If securities deliverable upon conversion of this Note, as provided above, are themselves convertible into the securities of an affiliate of a corporation formed, surviving or otherwise affected by the merger or other transaction, that issuer shall join in the supplemental Note which shall so provide. If this section applies, Section 3.5 does not apply.

ARTICLE IV

MISCELLANEOUS

4.1 Default. Upon the occurrence of any one or more of the Events of Default specified or referred to in the Agreement or in the other documents or instruments executed in connection therewith, all amounts then remaining unpaid on this Note may be declared to be immediately due and payable as provided in the Agreement.


4.2 Collection Costs. In the event that this Note shall be placed in the hands of an attorney for collection by reason of any Event of Default hereunder, the undersigned agrees to pay reasonable attorney's fees and disbursements and other reasonable expenses incurred by the Holder in connection with the collection of this Note.

4.3 Rights Cumulative. The rights, powers and remedies given to the Payee under this Note shall be in addition to all rights, powers and remedies given to it by virtue of the Agreement, any document or instrument executed in connection therewith, or any statute or rule of law.

4.4 No Waivers. Any forbearance, failure or delay by the Payee in exercising any right, power or remedy under this Note, the Agreement, any documents or instruments executed in connection therewith or otherwise available to the Payee shall not be deemed to be a waiver of such right, power or remedy, nor shall any single or partial exercise of any right, power or remedy preclude the further exercise thereof.

4.5 Amendments in Writing. No modification or waiver of any provision of this Note, the Agreement or any documents or instruments executed in connection therewith shall be effective unless it shall be in writing and signed by the Payee, and any such modification or waiver shall apply only in the specific instance for which given.

4.6 Governing Law. This Note and the rights and obligations of the parties hereto, shall be governed, construed and interpreted according to the laws of the State of New York, without reference to its choice of law principles, wherein it was negotiated and executed, and the undersigned consents and agrees that the State and Federal Courts which sit in the State of New York, County of New York shall have exclusive jurisdiction of all controversies and disputes arising hereunder.

4.7 No Counterclaims. The undersigned waives the right to interpose counterclaims or set-offs of any kind and description in any litigation arising hereunder and waives the right in any litigation with the Payee (whether or not arising out of or relating to this Note) to trial by jury.

4.8 Successors. The term "Payee" and "Holder" as used herein shall be deemed to include the Payee and its successors, endorsees and assigns.

4.9 Certain Waivers. The Company hereby waives presentment, demand for payment, protest, notice of protest and notice of non-payment hereof.

4.10 Stamp Tax. The Company will pay any documentary stamp taxes attributable to the initial issuance of the Common Stock issuable upon the conversion of this Note; provided, however, that the Company shall not be required to pay any tax or taxes which may be payable for of any transfer involved in the issuance or delivery of any certificates for the Common Stock in a name other than that of the Holder for which such Common Stock is issued, and in such case the Company shall not be required to issue or deliver any certificate for the Common Stock until the person requesting the same has paid to the Company the amount of such tax or has established, to the Company's satisfaction, that such tax has been paid.


4.11 Mutilated, Lost, Stolen or Destroyed Notes. In case this Note shall be mutilated, lost, stolen or destroyed, the Company shall issue and deliver in exchange and substitution for and upon cancellation of the mutilated Note, or in lieu of and substitution for the Note, mutilated, lost, stolen or destroyed, a new Note of like tenor and representing an equivalent right or interest, but only upon receipt of evidence satisfactory to the Company of such loss, theft or destruction and an indemnity, if requested, also satisfactory to it.

4.12 Maintenance of Office. The Company covenants and agrees that so long as this Note shall be outstanding, it will maintain an office or agency in New York (or such other place as the Company may designate in writing to the holder of this Note) where notices, presentations and demands to or upon the Company regarding of this Note may be given or made.

IN WITNESS WHEREOF, Halsey Drug Co., Inc. has caused this Note to be signed by its President and to be dated the day and year first above written.

ATTEST [SEAL]                             HALSEY DRUG CO., INC.


___________________________________       By:___________________________________
                                                  Michael Reicher
                                                  Chief Executive Officer


ATTACHMENT I

Assignment

For value received, the undersigned hereby assigns to ________________________, subject to the provisions of Section 11.13 of the Agreement, $_________________ principal amount of the Amended, Restated and Consolidated 10% Convertible Senior Secured Note due May 30, 1999 evidenced hereby and hereby irrevocably appoint _______________ attorney to transfer the Note on the books of the within named corporation with full power of substitution in the premises.

Dated:

In the presence of:



ATTACHMENT II

CONVERSION NOTICE

TO: HALSEY DRUG CO., INC.

The undersigned holder of this Note hereby irrevocably exercises the option to convert $_________________ principal amount of such Note and/or $______________________ amount of accrued interest on the principal of such Note (which may be less than the stated amount of principal thereof or accrued interest thereon) into shares of Common Stock of Halsey Drug Co., Inc., in accordance with the terms of such Note, and directs that the shares of Common Stock issuable and deliverable upon such conversion, together with a check (if applicable) in payment for any fractional shares as provided in such Note, be issued and delivered to the undersigned unless a different name has been indicated below. If shares of Common Stock are to be issued in the name of a person other than the undersigned holder of such Note, the undersigned will pay all transfer taxes payable with respect thereto.

Name and Address of Holder

Signature of Holder

Principal amount of Note to be converted $

Amount of accrued interest on the principal
of the Note to be converted $

If shares are to be issued otherwise then to the Holder:


Name of Transferee
Address of Transferee

Social Security Number of Transferee


Exhibit 10.49

[Form of Common Stock Purchase Warrant issued pursuant to the Amended, Restated and Consolidated Bridge Loan Agreement]

WARRANT TO PURCHASE
COMMON STOCK, PAR VALUE $.01 PER SHARE

OF

HALSEY DRUG CO., INC.

THIS WARRANT AND THE COMMON STOCK ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "ACT") NOR UNDER ANY STATE SECURITIES LAW AND MAY NOT BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR OTHERWISE TRANSFERRED UNTIL (1) A REGISTRATION STATEMENT WITH RESPECT THERETO IS EFFECTIVE UNDER THE ACT AND ANY APPLICABLE STATE SECURITIES LAW OR (2) THE COMPANY RECEIVES AN OPINION OF COUNSEL TO THE COMPANY OR OTHER COUNSEL TO THE HOLDER OF SUCH WARRANT REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH WARRANT AND/OR COMMON STOCK MAY BE PLEDGED, SOLD, ASSIGNED, HYPOTHECATED OR TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR APPLICABLE STATE SECURITIES LAWS.

This certifies that, for value received, [ ]or registered assigns ("Warrantholder"), is entitled to purchase from HALSEY DRUG CO., INC. (the "Company"), subject to the provisions of this Warrant, at any time during the Exercise Period (as hereinafter defined) [ ] shares of the Company's Common Stock, par value $.01 per share ("Warrant Shares"). The purchase price payable upon the exercise of this Warrant shall be $1.3313 per Warrant Share. The purchase price and the number of Warrant Shares which the Warrantholder is entitled to purchase are subject to adjustment upon the occurrence of the contingencies set forth in this Warrant, and as adjusted from time to time, such purchase price is hereinafter referred to as the "Warrant Price."

For purposes of this Warrant, the term "Exercise Period" means the period commencing on the date of issuance of this Warrant and ending on the seventh anniversary of such date.

This Warrant is subject to the following terms and conditions: