Item 3. Quantitative and qualitative disclosures about market risk
Our
primary market risk exposures are in the areas of interest rate risk. Our investment
portfolio of cash equivalents and debt securities is subject to interest rate
fluctuations, but we believe this risk is immaterial because of the short-term nature of
these investments.
Item 4. Controls and
procedures
Under
the direction of the principal executive officer and principal financial officer, the
Company has evaluated the effectiveness of its disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2007. Based on that
evaluation, the Company has concluded that its disclosure controls and procedures were
effective.
There
were no significant changes in the Companys internal controls over financial
reporting or in other factors that could significantly affect these controls during the
quarter ended March 31, 2007, including any corrective actions with regard to significant
deficiencies and material weaknesses.
PART II Other
information
Item
1. Legal proceedings
On
February 15, 2002 and April 7, 2005, we commenced actions for patent infringement in the
United States District Court for the District of Massachusetts against Cutera, Inc.
seeking both monetary damages and injunctive relief. The Massachusetts General Hospital in
Boston, Massachusetts was added as a plaintiff in these lawsuits. In the first suit,
Cuteras CoolGlide Laser Systems, including the CoolGlide CV, Excel, Vantage and Xeo,
were alleged to infringe U.S. Patent No. 5,735,844. In the second lawsuit, Cuteras
Lamp Systems, including the CoolGlide Xeo and Solera Opus platforms using the PW770
handpiece, were alleged to infringe both the 5,735,844 Patent as well as U.S. Patent No.
5,595,568. We have an exclusive license to these patents from the Massachusetts General
Hospital.
On
June 5, 2006, we announced the resolution of our patent infringement lawsuits against
Cutera, Inc. through the execution of a Non-Exclusive Patent License Agreement and a
Settlement Agreement. Under the License Agreement, we granted Cutera a non-exclusive,
royalty bearing license to U.S. Patent Nos. 5,595,568 & 5,735,844 & corresponding
foreign patents and applications in the professional field, excluding the consumer field
which is exclusively licensed to Gillette. Cutera admitted that their products infringe
these patents and that these patents are valid and enforceable. In addition, Cutera agreed
not to challenge the infringement, validity and enforceability of these patents in the
future. Cutera paid us an estimated payment for royalties due on past sales of their laser
and lamp-based hair removal systems beginning with their initial sales in 2000 through
March 31, 2006, interest and reimbursement of our legal costs. The final amounts due to us
were subject to an audit by an independent accounting firm which was completed in the
fourth quarter of 2006. Starting on April 1, 2006, Cutera began paying us a royalty on
sales of its existing light based hair removal systems, and Cutera will pay us a royalty
on sales of its later developed light-based hair removal systems.
32
For
more information, please see the Settlement Agreement, the Non-Exclusive Patent License
Agreement, the Consent Judgments and Stipulations of Dismissal filed as Exhibits 99.1,
99.2, 99.3 and 99.4 to a Current Report on our Form 8-K filed June 5, 2006.
On
July 7, 2006, we commenced an action for patent infringement against Alma Lasers, Inc. in
the United States District Court for the District of Massachusetts seeking both monetary
damages and injunctive relief. The complaint alleged Almas Harmony, Soprano and
Sonata Systems which use pulsed light and laser technology for hair removal willfully
infringe U.S. Patent Nos. 5,595,568 & 5,735,844, which are exclusively licensed to us
by the Massachusetts General Hospital. On July 27, 2006, we filed an amended complaint
including an additional claim against Alma for unfair competition due to infringement by
Almas Harmony System of the distinctive trade dress of our products, including the
unique, distinctive, and immediately recognizable design of our EsteLux, MediLux and
StarLux Systems.
On
April 2, 2007, we announced the resolution of our lawsuit against Alma Laser, Inc. through
the execution of a Non-Exclusive Patent License Agreement, a Trade Dress Settlement
Agreement, and a Settlement Agreement. Under the Patent License Agreement, we granted Alma
a non-exclusive, royalty bearing license to U.S. Patent Nos. 5,595,568 & 5,735,844
& corresponding foreign patents and applications in the professional field, excluding
the consumer field which is exclusively licensed to Gillette. Alma admitted that their
products infringe these patents and that these patents are valid and enforceable. In
addition, Alma agreed not to challenge the infringement, validity and enforceability of
these patents in the future. Alma paid us an estimated payment for royalties due on past
sales of their laser and lamp-based hair removal systems beginning with their initial
sales in 2003 through the date of settlement, plus interest and reimbursement of our legal
costs. Alma also paid us an estimated payment for trade dress fees on past sales of their
Harmony and Aria Systems and interest, and Alma agreed to change the trade dress of the
Harmony and Aria systems within the next six to nine months. The final amounts due to us
are subject to an audit by an independent accounting firm which is scheduled to begin in
the second quarter of 2007. Starting on March 30, 2007, Alma will begin paying us a
royalty on sales of its existing light based hair removal systems, and Alma will pay us a
royalty on sales of its later developed light based hair removal systems.
For
more information, please see the Settlement Agreement, the Non-Exclusive Patent License
Agreement, the Trade Dress Settlement Agreement, the Consent Judgments and Stipulations of
Dismissal filed as Exhibits 10.1, 10.2, 10.3, 10.4 and 10.5 to a Current Report on our
Form 8-K filed April 2, 2007.
On
August 9, 2006, we commenced an action for patent infringement against Candela Corporation
in the United States District Court for the District of Massachusetts seeking both
monetary damages and injunctive relief. The complaint alleges Candelas GentleYAG and
GentleLASE systems which use laser technology for hair removal willfully infringe U.S.
patent No. 5,735,844, which is exclusively licensed to us by the Massachusetts General
Hospital. Candela answered the complaint denying that its products infringe valid claims
of the asserted patents and filing a counterclaim seeking a declaratory judgment that the
asserted patent and U.S. patent No. 5,595,568 are invalid and not infringed. We filed a
reply denying the material allegations of the counterclaims. This lawsuit has been
transferred to Judge Rya Zobel, the judge who presided over Palomar v Cutera, Inc. A
Markman Hearing is scheduled for August 2, 2007. The current schedule has the parties
ready for trial by June 2008 though no trial date has yet been set. We filed an amended
complaint on February 16, 2007 to add the Massachusetts General Hospital as a plaintiff.
In addition, we further allege that Candelas new GentleMAX system willfully
infringes U.S. Patent No. 5,735,844 and that Candelas new Light Station system
willfully infringes both U.S. Patent Nos. 5,735,844 and 5,595,568. On February 16, 2007,
Candela filed an amended answer to our complaint adding allegations of inequitable
conduct, double patenting and violation of Massachusetts General Laws Chapter 93A. On
February 28, 2007 Palomar filed a response to Candelas amended complaint pointing
out many weaknesses in Candelas new allegations.
33
On
August 10, 2006, Candela Corporation commenced an action for patent infringement against
us in the United States District Court for the District of Massachusetts seeking both
monetary damages and injunctive relief. The complaint alleges that our StarLux System with
the LuxV handpiece willfully infringes U.S. Patent No. 6,743,222 which is directed to acne
treatment, that our QYAG5 System willfully infringes U.S. Patent No. 5,312,395 which is
directed to treatment of pigmented lesions, and that our StarLux System with the LuxG
handpiece willfully infringes U.S. Patent No. 6,659,999 which is directed to wrinkle
treatment. On October 25, 2006, Candela filed an amended complaint which did not include
U.S. Patent No. 6,659,999. Consequently, Candela no longer alleges in this lawsuit that
the StarLux System with LuxG handpiece infringes its patents. With regard to the two
remaining patents, Candela is seeking to enjoin us from selling these products in the
United States if found to infringe the patents, and to obtain compensatory and treble
damages, reasonable costs and attorneys fees, and other relief as the court deems
just and proper. On October 30, 2006 we answered the complaint denying that our products
infringe the asserted patents and filing counterclaims seeking declaratory judgments that
the asserted patents are invalid and not infringed. In addition, with regard to U.S.
Patent No. 5,312,395, we filed a counter claim of inequitable conduct. Judge Joseph Tauro
has been appointed as the presiding judge. Following a scheduling hearing on January 18,
2007, the Judge set a partial discovery schedule but did not yet set a date for a Markman
Hearing. We are defending the action vigorously and believe that we have meritorious
defenses of non-infringement, invalidity and inequitable conduct. However, litigation is
unpredictable and we may not prevail in successfully defending or asserting our position.
If we do not prevail, we may be ordered to pay substantial damages for past sales and an
ongoing royalty for future sales of products found to infringe in the United States. We
could also be ordered to stop selling any products in the United States that are found to
infringe.
On
December 19, 2006, Candela Corporation commenced an action for patent infringement against
us in the United States District Court for the Eastern District of Texas, seeking both
monetary damages and injunctive relief. The complaint alleges that our StarLux System with
the LuxY handpiece willfully infringes U.S. Patent No. 6,659,999 and that our StarLux
System with the Lux1540 handpiece willfully infringes related U.S. Patent Nos. 5,810,801
and 6,120,497. The three asserted patents are directed to wrinkle treatment. Candela is
seeking to enjoin us from selling these products in the United States if found to infringe
the patents, and to obtain compensatory and treble damages, reasonable costs and
attorneys fees, and other relief as the court deems just and proper. On January 10,
2007, we answered the complaint denying that our products infringe the asserted patents
and filing counterclaims seeking declaratory judgments that the asserted patents are
invalid and not infringed. On April 6, 2007, Candela filed their infringement contentions
which modified their complaint to accuse the Lux1540, Lux1540-Z, LuxIR, LuxDeepIR, LuxB,
LuxG and LuxY handpieces for use with the StarLux, StarLux 500, MediLux and EsteLux
Systems of infringing the three asserted patents. We are defending the action vigorously
and believe that we have meritorious defenses of non-infringement and invalidity. However,
litigation is unpredictable and we may not prevail in successfully defending or asserting
our position. If we do not prevail, we may be ordered to pay substantial damages for past
sales and an ongoing royalty for future sales of products found to infringe in the United
States. We could also be ordered to stop selling any products that are found to infringe
in the United States.
Item 2. Changes in securities, use of proceeds and issuer purchases of securities
None.