PUBLIC HEALTH SERVICE SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT L-068-2002/0
Exhibit 10.9
PUBLIC HEALTH SERVICE
SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT L-068-2002/0
AMENDMENT A-065-2003
This Amendment A-065-2003 (“Second Amendment”) of the Exclusive Patent License L-068-02/0 (“Agreement”), and of the First Amendment L-068-02/1 (“First Amendment”) of the Agreement, is made between the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), or the Food and Drug Administration (“FDA”), hereinafter singly or collectively referred to as (“PHS”), agencies of the United States Public Health Service within the Department of Health and Human Services (“DHHS”) through the Office of Technology Transfer, NIH, having an address at 0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxx 00000-0000, X.X.X. and Procept, Inc., having offices at the address indicated on the Signature Page, hereinafter referred to as “Licensee”.
Whereas, PHS desires the Agreement to be amended a second time in order to resolve issues concerning the following: (a) Paragraph 6.04 and (b) Appendix E of said Agreement, in order to establish the time frame of sixty (60) days for the benchmark royalty payment; and
Whereas, PHS desires the First Amendment to be amended a first time in order to resolve issues concerning the following: (a) Paragraph 3 of the First Amendment L-068-02/1, in order to properly reflect a change in the language of the agreement from “Amended Appendix C will now read” to “Amendment to Appendix C shall now read,” and
Whereas, PHS and Licensee are willing to amend the terms of the Agreement and of the First Amendment to accommodate these issues.
Now Therefore, PHS and Licensee, intending to be bound, hereby agree that the following changes will be made to the Agreement and to the First Amendment:
1. Amended Paragraph 6.04 of the Agreement will now read as follows:
Licensee agrees to pay PHS, within sixty (60) days of achieving a benchmark, the benchmark royalties as set forth in Appendix C.
2. Amended Appendix E of the Agreement will now read:
APPENDIX E—Benchmarks and Performance
The company has established the following estimated timeline:
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First filing of a Licensee or sublicensee-sponsored Investigational New Drug Application with The United States Food and Drug Administration (FDA) or foreign equivalent in a Major Market Country |
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2Q2002 NB: Extension into 3Q2002 is allowable, if filing date is in compliance with the CRADA. |
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Completion of enrollment of the first Licensee or sublicensee-sponsored Phase II or III clinical trial with the FDA or its foreign equivalent in a Major Market Country |
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2Q2004 |
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First filing of a Product License Application or foreign equivalent in a Major Market Country |
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3Q2007 |
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First receipt of Approval Letter by the FDA or foreign equivalent in a Major Market Country |
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1Q2008 |
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The Licensee agrees to use their commercially reasonable best efforts to attain the aforementioned milestones for its performance under this agreement and, within sixty (60) days of achieving a milestone, shall notify the PHS that such milestone has been achieved.
3. Amended Paragraph 3 of the First Amendment shall now read:
Amendment to Appendix C shall now read:
Licensee agrees to pay PHS sublicensing royalties as follows:
• The greater of Twenty-Two and One-Half Percent (22.5%) of the royalties received by Licensee or any of its Affiliates from Net Sales by any sublicensee, including Sublicensee, of Licensed Products or Licensed Processes or One and Four Fifths Percent (1.8%) of Net Sales by any sublicensee(s), including any subtier licensing.
SIGNATURES BEGIN ON NEXT PAGE
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SECOND AMENDMENT TO PHS LICENSE AGREEMENT L-068-02/0
PHS SECOND AMENDMENT TO PATENT LICENSE AGREEMENT—EXCLUSIVE
SIGNATURE PAGE
For PHS:
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/s/ Xxxx Xxxxxxx |
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December 31, 2002 |
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Xxxx Xxxxxxx, Ph.D. |
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Director, Division of Technology Development and Transfer |
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Office of Technology Transfer |
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National Institutes of Health |
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Mailing Address for Notices: |
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Office of Technology Transfer |
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National Institutes of Health |
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0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000 |
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Xxxxxxxxx, Xxxxxxxx 00000-0000 X.X.X. |
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For Licensee (Upon, information and belief, the undersigned expressly certify or affirm that the contents of any statements of Licensee made or referred to in this document are truthful and accurate.):
PROCEPT, INC.
000 Xxxxxxxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, XX 00000
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By: Xxxxxxxxx X. Xxxxx |
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Name: |
/s/ Xxxxxxxxx X. Xxxxx |
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Title: President and Chief Executive Officer |
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Date: |
January 13, 2003 |
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ACKNOWLEDGEMENT AND ACCEPTANCE
AOI Pharmaceuticals, Inc. (“AOIP”), by its signature below, acknowledges and agrees to the following:
1. AOIP shall be bound by the terms of Amendments L-068-02/2 and L-068-02/1 to the Revised Licensing Agreement (L-068-02/0).
2. AOIP shall be bound by the terms of Article 4 of the Revised License Agreement as amended by Amendment L-068-02/1.
3. Amendments L-068-02/2 and L-068-02/1 to the Revised License Agreement (L-068-02/0) serve as Amendments to the Procept, Inc./AOIP Sublicensing Agreement.
For Sublicensee (Upon, information and belief, the undersigned expressly certify or affirm that the contents of any statements of Sublicensee made or referred to in this document are truthful and accurate.):
AOI PHARMACEUTICALS, INC.
An Access Oncology Company
000 Xxxxxxxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, XX 00000
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By: Xxxxx Xxxxxxxxx, M.D. |
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Name: |
/s/ Xxxxx Xxxxxxxxx |
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Title: Chief Executive Officer |
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Date: |
February 10, 2003 |
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