Specified Compound definition
Examples of Specified Compound in a sentence
Additionally, in the event (x) a patent issues with respect to any Abandoned Patent Rights and (y) ▇▇▇▇▇ does not elect to reimburse ONYX pursuant to clause (i) of this Section 4.2(e) and assume prosecution and maintenance of such Patent Rights pursuant to clause (ii) of this Section 4.2(e), then ONYX shall be permitted to pursue any product, including a Specified Compound in the Licensed Field, that is covered by any such Abandoned Patent Right.
Each Party shall be responsible for its own internal costs and expenses required for the discovery, research and/or development of any ESC, Specified Compound or Product under the Collaboration, except as set forth in the remainder of this Section 2.7 or under Section 5.2 below.
Codexis and its Affiliates have, and, to Codexis’ Knowledge, their respective contractors, agents and consultants have, conducted all Development with respect to the Specified Compounds and any Product containing a Specified Compound that has been conducted prior to the Effective Date in accordance with GLP, GCP, and GMP, to the extent applicable and required.
Without limiting the foregoing, Penwest will involve Edison to the extent practicable in the development of any Specified Compound (or corresponding Product) through completion of Phase IIb Studies, including reasonably considering any comments Edison provides to Penwest with respect to clinical trials and protocols associated therewith.
The GOC shall endeavor to review and approve any Development Plan for a Specified Compound, and any proposed amendments thereto, within thirty (30) days of submission thereof.
Notwithstanding anything in this Agreement to the contrary, Penwest shall have the right to terminate the development and commercialization of a Specified Compound upon at least sixty (60) days’ prior written notice to Edison thereof, provided that Penwest has on-going development activities with respect to one or more other Specified Compounds under this Agreement, and such termination shall in no way be deemed a breach of Penwest’s obligations hereunder.
In the event Penwest terminates development activities for a Specified Compound as set forth in this Section 2.3.4 after expiration of the Research Funding Period, the Parties shall promptly meet and, through the GOC, agree upon a plan pursuant to which Penwest will fund Edison’s efforts to discover one or more Replacement Compounds if the GOC determines that such efforts are necessary beyond the Research Funding Period.
In the event that either Party becomes aware that any Valid Claim of any Edison Patent is being infringed or misappropriated by a Third Party, or is subject to a declaratory judgment action arising from such infringement or misappropriation, in each case with respect to the manufacture use, sale, offer for sale or importation of any pharmaceutical product incorporating any Specified Compound (an “Infringing Product”), such Party shall promptly notify the other Party.
Edison is not aware of any pending or threatened claim or litigation (or received notice of a potential claim or litigation) which alleges any issued patents of a Third Party would be infringed by the development and commercialization of any Specified Compound hereunder.
Subject to such approval, a copy of the Development Plan for each Specified Compound shall be signed and appended to the minutes of the GOC meeting at which such Development Plan is approved.