Exhibit 10.13
THE SYMBOL ‘***’ IS USED THROUGHOUT THIS EXHIBIT TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AS CONFIDENTIAL.
United States Public Health Service
Second Amendment L-103-96/2
This second amendment (“Second Amendment”) to the License Agreement L-103-96/0 entered into on November 19, 1997, as amended by Amendment L-103-96/1 entered into on March 28, 2002 (collectively, the “Original Agreement”) by the Public Health Service (hereinafter “PHS”) through the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804 and Angiotech Pharmaceuticals, Inc. (hereinafter “Licensee”), a Canadian corporation having its principal office at 1618 Station Street, Vancouver, B.C. CANADA, V6A 1B6, is effective as of the last signature date below.
WHEREAS,
A.
PHS andLicensee wish to allowLicenseeadditional time to submit royalty reports and royalty payments under theOriginal Agreement.
B.
PHS andLicensee wish to modify the method of measuring the value of access to the valid and enforceableLicensed Patent Rights with respect to certainLicensed Products.
C.
PHSandLicensee have determined the desirability of amending theOriginal Agreementto facilitate the developmentof Licensed Productsunder the Licensed Patent Rights.
NOW THEREFORE, in consideration of the mutual covenants set forth herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged,Licensee andPHS agree as follows:
1.
Section 9.04. Licensee andPHS hereby agree to amend Section 9.04 of theOriginal Agreement by deleting in its entirety the first sentence of such section and replacing it with the following:
“Licensee shall submit toPHS within seventy-five (75) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half-year period the amount of theLicensed Products sold orLicensed Processes practiced by or on behalf ofLicensee in each country within theLicensed Territory, theNet Sales, and the amount of royalty accordingly due.”
2.
Section 2.07 (Licensed Processes). Licensee andPHS hereby agree to amend Section 2.07 of theOriginal Agreement by deleting in its entirety the text of such section and replacing it with the following:
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“Licensed Process(es)” means processes which, in the course of being practiced in:
(a)
the [***] or [***] would, in the absence of this Agreement, infringe one or more claims of theLicensed Patent Rightsin [***] that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction, where such activity is [***]; or
(b)
[***] would, in the absence of this Agreement, infringe one or more claims of theLicensed Patent Rightsin [***] that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.”
3.
Section 2.08 (Licensed Products). Licensee andPHS hereby agree to amend Section 2.08 of theOriginal Agreement by deleting in its entirety the text of such section and replacing it with the following:
“Licensed Product(s)” means tangible materials the manufacture, use, or sale of which in:
(a)
the [***] or [***] would, in the absence of this Agreement, infringe one or more claims of theLicensed Patent Rights in[***] that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction, where such activity is[***]; or
(b)
[***] would, in the absence of this Agreement, infringe one or more claims of theLicensed Patent Rightsin [***] that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.”
4.
Appendix C, Section III (Royalties). Licensee andPHS hereby agree to amend Appendix C, Section III, Paragraph A of theOriginal Agreement by deleting in its entirety the text added to the end of that Paragraph A pursuant to Amendment L-103-96/1 entered into on March 28, 2002, and replacing it with the following:
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“;provided that, notwithstanding the foregoing, in the case of two-componentCombined Products as described in the second sentence of Section 2.13, the following shall apply:
(i)
the term “Licensed Product” with regard only to such two-componentCombined Products shall mean tangible materials the manufacture, use, or sale of which [***] in theLicensed Territory would, in the absence of this Agreement, infringe one or more claims of theLicensed Patent Rightsin [***] that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction, where such activity is [***];
(ii)
in the case of aCombined Product as described in the foregoing paragraph (i) that is[***],PHS andLicensee agree that the royalty rates onNet Sales of suchCombined Products manufactured and sold in theLicensed Territory shall be (a) [***] percent ([***]%) onNet Sales equal to or less than US$[***] byLicensee or a sublicensee in a given year, and (b) [***] percent ([***]%) onNet Sales greater than US$[***]byLicensee or that sublicensee that same year (Licensee shall be entitled to no further reduction of these [***]% and [***]% royalty rates under Paragraph B below, and such royalty rates shall apply to theNet Sales of suchCombined Product without further reduction of theNet Sales price under Section 6.12 of thisAgreement );
(iii)
in the case of aCombined Product as described in the foregoing paragraph (i) that is [***],PHS andLicensee agree that the royalty rates onNet Sales of suchCombined Products manufactured and sold in theLicensed Territory shall be (a) [***] percent ([***]%) onNet Sales equal to or less than US$[***] byLicensee or a sublicensee in a given year, and (b) [***] percent ([***]%) onNet Sales greater than US$[***] byLicensee or that sublicensee that same year, and such [***]% and [***]% royalty rates shall apply to Net Sales of such Combined Products without further reduction of theNet Sales price under Section 6.12 of thisAgreement).
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5.
Performance of Benchmark. PHS hereby acknowledges that Licensee has performed each of the Benchmarks described in Sections I and II of Appendix E of the Original Agreement (as amended by Amendment L-103-96/1). Further,PHS hereby irrevocably waives the right to take any action againstLicensee with respect to suchBenchmarks, including without limitation any right to terminate or modify theOriginal Agreement in any way.
6.
ThisSecond Amendment shall become effective immediately upon execution byPHS andLicensee.
7.
TheOriginal Agreement shall continue in full force and effect, unchanged except as modified by thisSecond Amendment.
8.
ThisSecond Amendment may be executed in multiple counterparts, each of which so executed shall be deemed an original, but all such counterparts shall together constitute but one and the sameSecond Amendment.
IN WITNESS WHEREOF, the parties hereto have caused thisSecond Amendment to be executed and delivered by their duly authorized representatives as of the last signature date below.
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FOR PUBLIC HEALTH SERVICE:
/s/ Steven Ferguson
5/23/07
____________________________________
__________
Steven Ferguson
Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.
FOR LICENSEE:
ANGIOTECH PHARMACEUTICALS, INC.
/s/ K. Thomas Bailey
May 21, 2007
____________________________________
__________
K. Thomas Bailey
Date
Chief Financial Officer
Mailing Address for Notices:
Angiotech Pharmaceuticals, Inc.
1618 Station Street
Vancouver, British Columbia
Canada V6A 1B6
Attention: General Counsel and Vice President, Business Development
Any false or misleading statements made, presented, or submitted to theGovernment, including any relevant omissions, under thisSecond Amendment and during the course of negotiation of thisSecond Amendment are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§ 3801-3812 (civil liability) and 18 U.S.C. § 1001 (criminal liability including fine(s) and/or imprisonment).
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