AMENDMENT NO. 4 TO DEVELOPMENT AND LICENSING AGREEMENT
Exhibit 10.2
AMENDMENT NO. 4 TO
DEVELOPMENT AND LICENSING AGREEMENT
THIS AMENDMENT NO. 4 TO THE DEVELOPMENT AND LICENSING AGREEMENT (the “Amendment”) is made as of August 5, 2015 (the “Amendment Date”), by and between Eagle Pharmaceuticals, Inc. (“Eagle”), and SciDose LLC, (“SciDose”), and amends the June 12, 2007 Development and Licensing Agreement (the “Original Agreement”), by and between Eagle and SciDose. Capitalized terms used in this Amendment and not otherwise defined shall have the same meanings ascribed to such terms in the Original Agreement, as previously amended.
WHEREAS, Eagle and SciDose desire to amend the Original Agreement, as more particularly set forth herein.
NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Eagle and SciDose agree as follows:
1. Amendment to Section 1.30 (ii). The general reference to “all parenteral formulations of Bivalirudin” in Section 1.30 (ii) is deleted, and replaced with:
1.30 (ii) the Eagle ready-to-use (“RTU”) Bivalirudin product (the “Eagle Bivalirudin Product”) that is the subject of the 505(b)(2) New Drug Application (“NDA”) submitted to the U.S. Food and Drug Administration on or about May 20, 2015.
2. Amendment to Section 1.35. Section 1.35 of the Original Agreement, as previously amended, is hereby amended by deleting the entire clause and replacing it with:
1.35 “ROYALTY RATE” means (i) with respect to the EAGLE BIVALIRUDIN PRODUCT, fifteen percent (15%); (ii) with respect to any PRODUCT that is subject to a 505(b)(2) application, fifty percent (50%); and (iii) with respect to any PRODUCT that is subject to an ANDA application, thirty percent (30%).
3. Development Costs and Milestone Payments Made By Eagle. Eagle hereby waives any claim of any kind that it may have and which could be asserted through and including the Amendment Date against SciDose for the recovery from SciDose of either (i) any unreimbursed costs incurred by Eagle related to the development of the Eagle Bivalirudin Product, and (ii) any refund of milestone payments under Sections 4.1.3 and 3.1.2 of the Original Agreement that were previously made by Eagle to SciDose relating to any parenteral formulation of Bivalirudin.
4. Effect on the Original Agreement. Except as specifically amended herein, the Original Agreement, all other documents, instruments and agreements executed and/or delivered in connection therewith, shall remain in full force and effect, and are hereby ratified and confirmed. Each reference in the Original Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of like import shall mean and be a reference to the Original Agreement as amended hereby.
5. Entire Agreement. The Original Agreement, as modified by this Amendment, and the other writings specifically identified therein and herein or contemplated thereby and hereby, is complete, reflects the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all previous written or oral negotiations, commitments and writings.
6. Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an original and any of which shall constitute a single document. A facsimile (or pdf) signature of an authorized signatory of any Party shall be valid and binding and constitute due execution and delivery of this Amendment by such Party.
7. Governing Law. This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware without regard to its conflict of law rules or principles.
IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed and delivered by their respective proper and duly authorized representatives as of the date first set forth above.
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Name: |
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President and CEO |
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SCIDOSE, LLC | |
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By: |
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇ |
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Name: |
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Title: |
President and CEO |