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QUARK PHARMACEUTICALS INC
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S-1/A
Nov 24, 5:25 PM ET
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QUARK PHARMACEUTICALS INC S-1/A
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16
WHEREAS
“Valid Patent Claim” shall mean: (i) a claim under an issued and unexpired patent which has not been revoked, held unenforceable or invalidated by a decision of a court or other governmental agency of competent jurisdiction, is unappealable or for which an appeal has not been filed within the time allowed for appeal and which has not been discharged, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or (ii) a claim in a pending patent application, which application: (a) is under active prosecution; or (b) for which formal examination has been requested; or (c) is a provisional application, the benefit of which can be claimed in a non-provisional application.
4.8 Diligent Performance of the Development and Commercialization Obligations of the Parties.
4.8.1. Diligent Performance of Development. Each Party, by itself or through
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
its Affiliates or sub licensees, undertakes to employ commercially reasonable efforts, including funding consistent with such efforts, to develop Products in accordance with such Party’s own individual development plan and (if applicable) the Joint Development Program and to achieve the Development Milestones set forth in Section 11.4. Specifically, each Party, by itself or through Affiliates or sublicensees, undertakes to employ its best efforts, including funding consistent with such efforts, to carry out all efficacy, pharmaceutical, safety, toxicological and clinical tests, trials and studies and all other activities necessary in order to obtain Regulatory Approval for the production, use and sale of Products in such Party’s therapeutic area of interest. In the event that a Party (or its Affiliates of sublicensees) does not achieve the Development Milestones set, the other Party may terminate the licenses granted to the Non-Achieving Party as set forth in Section 11.4.
4.8.3. Commercial Manufacture of Product. Following completion of the Development Stage, each Party shall be entitled, at such Party’s sole discretion, to (i) continue obtaining supplies of the Products and Drug Products for all of such Party’s commercial needs from the third party-manufacturer appointed by the Parties in accordance with Section 3.7.1 or (ii) to appoint and qualify a different or additional manufacturer to supply such Party with commercial quantities of Products and Drug Products, and the provisions of Section 3.7.1 shall apply, mutatis mutandis, to such additional or different manufacturer.
10. INDEMNITY
11. TERM AND TERMINATION
16. NOTICES
Thomas Christély, COO and CFO
Dr. Klaus Giese, CSO and VP Research
Dr. Daniel Zurr, President and CEO
Dr. Rami Skaliter, EVP Research and Development
Schedule A2
Schedule B
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