EXHIBIT 10.14
[CABG Medical, Inc. Letterhead]
June 3, 2004
Mr. Michael Dale
Chairman, President & CEO
ATS Medical, Inc.
3905 Annapolis Lane N., Suite 105
Minneapolis, Minnesota 55447
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Re:
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Amendment to Technology Transfer Agreement between ATS
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Medical, Inc. and Manuel A. Villafaña
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Dear Mr. Dale:
This letter concerns the Technology Transfer Agreement Dated June 5, 1996
between ATS Medical, Inc. (ATS) and Manuel A. Villafaña (the Agreement).
The purpose of this amendment is to (i) transfer the rights and obligations of
Manuel A. Villafaña to CABG Medical, Inc. (CABG), (ii) amend the royalty
payment provision set forth in Section 2 of the Agreement, and (iii) amend the
termination provision set forth in Section 6 of the Agreement.
Accordingly, this letter confirms the assignment of the rights and obligations
of Manuel A. Villafaña to CABG and acknowledges the consent thereto by ATS.
Additionally, this letter amends and supercedes Sections 2 and 6 of the
Agreement. Specifically, Section 2 of the Agreement is hereby amended and
restated to read in its entirety as follows:
2 Royalty Obligations.
(a) Definitions. The following words and phrases, as used in this
Agreement, shall have the meaning ascribed below:
Net Sales means the gross amount received on the sale of Royalty
Products by CABG (excluding sales for use in clinical trials or
other scientific testing for which CABG receives no revenue),
less:
(i) discounts, credits, and rebates, except any discounts,
credits and rebates granted in consideration of such third
partys agreement to purchase any product other than Royalty
Products (other than where such discounts, credits or rebates
are across-the-board discounts, credits or rebates applied to
the Royalty Products and other products as part of an overall
program of discounts, credits or rebates established by CABG
covering a broad range of products);
(ii) allowances, adjustments, chargebacks, rejections, recalls
and returns;
(iii) management fees to group purchasing organizations, such
fees to be calculated as that percentage of the total
management fees associated with a purchase of products which
include the Royalty Products, equivalent to the proportionate
economic value of the Royalty Products relative to the total
economic value contributed by all the other items purchased;
(iv) sales, excise, similar taxes; turnover, inventory,
value-added and similar taxes; and
(v) transportation, insurance and other handling expenses
directly chargeable to such sales;
provided, however, that if a Royalty Product is sold together with
another item (whether as part of the sale of combination product,
package, system, kit or tray or otherwise) at a unit price,
whether packaged together or separately, Net Sales means the
Net Sales of such combination, multiplied by (x) a fraction
A/(A+B) where A is the average selling price (ASP) of the
Royalty Product when sold separately and B is the ASP of the other
item when sold separately, or (y) if the ASP of the Royalty
Product or the other item is not available, a fraction determined
by the mutual agreement of the parties, which represents the
proportionate economic value of the Royalty Product relative to
the economic value contributed by the other item. In either case
(x) or (y), the ASP of the Royalty Product shall be no less than
the CABG cost of goods sold for the Royalty Product. In no case
shall the amount of Net Sales include amounts paid for any item or
service other than a Royalty Product or exceed the ASP with
respect to a Royalty Product.
In the event CABG receives any fixed payment, fee or in-kind
consideration from the third party in consideration of any
discount, credit, rebate or similar allowance granted to such
third party in connection with the sale of any Royalty Product,
the dollar amount equal to such consideration shall be added to
the gross amount invoiced for such sale for purposes of
calculating Net Sales.
Patent Right or Patent Rights means: (x) U.S. Patent No.
6,241,761 (Stented Grafts for Coupling Vascular Members) issued on
June 5, 2001, and U.S. Patent No. 6,241,764 (Stented Grafts
Coupling Vascular Members) issued on June 5, 2001 (including any
divisions, continuations, reexaminations, reissue substitution
applications thereof and foreign
applications based thereon) and (y) any and all patents issuing
therefrom and extensions thereof.
Royalty Product means a product developed and sold by CABG that
is covered by a Valid Claim of an Unexpired patent that is
included within the Patent Rights.
Unexpired shall mean a patent that has not reached its
expiration date, been abandoned, cancelled, disclaimed, awarded to
another party in an interference proceeding, or been declared
invalid or unenforceable by a court or other authority of
competent jurisdiction (including final rejection in a
re-examination or re-issue proceedings).
Valid Claim means a claim of an issued, Unexpired patent
included in the Patent Rights, which has not been:
(i) held invalid, unpatentable or unenforceable by a final
decision, which was not appealed or is unappealable, of a court
of competent jurisdiction, or an administrative agency having
authority over patents, or
(ii) admitted to be invalid, unpatentable or unenforceable by
the holder by reissue, disclaimer or otherwise.
(b) Earned Royalty. Following marketing approval by the United
States Food and Drug Administration (FDA) of any Royalty Product,
CABG shall pay ATS an earned royalty of *** percent (*%) on Net
Sales of such Royalty Product sold anywhere in the world. Prior to
FDA approval of any Royalty Product, CABG shall pay ATS an earned
royalty as described in parts (i), (ii), and (iii) below.
(i)
Net Sales of Royalty Products in the United States
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Prior to CABG obtaining marketing approval of any Royalty Product
by the FDA, CABG shall pay ATS an earned royalty of *** percent
(*%) on Net Sales of such Royalty Product sold in the United
States.
(ii)
Net Sales of Royalty Products outside the United States
between the June 5, 1996 and March 31, 2008
Prior to CABG obtaining marketing approval of any Royalty Product
by the FDA, from the June 5, 1996 to March 31, 2008, CABG shall
pay ATS an earned royalty of *** percent (*%) on Net Sales of such
Royalty Product sold outside the United States.
(iii)
Net Sales of Royalty Products outside the United States
after March 31, 2008
After March 31, 2008, CABG shall pay ATS an earned royalty of ***
percent (*%) on Net Sales of any Royalty Product sold outside the
United States if such sale is made prior to CABG receiving
marketing approval for such
Royalty Product by a regulatory body of competent jurisdiction
outside the United States; however, after March 31, 2008 and upon
CABG receiving marketing approval of such Royalty Product by a
regulatory body of competent jurisdiction outside the United
States, CABG shall thereafter pay ATS an earned royalty of ***
percent (*%) on Net Sales of such Royalty Product sold in that
jurisdiction.
Section 6 of the Agreement is hereby amended and restated to read in its
entirety as follows:
6. Termination. This Agreement shall terminate when there are no
Unexpired patents included in the Patent Rights. Upon termination, CABG will
continue to possess all rights in the Project in perpetuity, and no further
payments to ATS will be required.
Except as specified in this letter agreement, all terms of the Agreement remain
unchanged. Capitalized terms used in this letter agreement and not otherwise
defined have the meanings given to them in the Agreement. As amended hereby,
the Agreement shall be read and construed as one and the same instrument.
Sincerely,
/s/ John L. Babitt, CFO
John L. Babitt
President & CFO
Agreed and accepted by:
ATS Medical, Inc.
/s/ Michael Dale
Michael Dale
Chairman, President & CEO
/s/ Manuel A. Villafaña
Manuel A. Villafaña,
individually
NOTE: IN THE EVENT OF A CHANGE IN CONTROL, VIA THE SALE OR OTHERWISE MEANS, OF
CABG MEDICAL, THIS AMENDMENT WILL BECOME NULL AND VOID, AND ALL PREVIOUS
REQUIREMENTS AND OBLIGATIONS WITH RESPECT TO THE TECHNOLOGY TRANSFER AGREEMENT
DATED JUNE, 1996, BETWEEN ATS MEDICAL AND MANUEL VILLAFANA WILL RESUME
IMMEDIATELY. /s/ M.D., M.A.V.