Manufacturing Matters. (i) To the extent vTv so requests within [***] days after the effective date of termination, Reneo shall use commercially reasonable efforts to, and to cause any Affiliate it controls (within the meaning of Section 1.1) to, [***]; provided that [***]; provided, further, that, [***].
Manufacturing Matters. At AVEO’s option, to be exercised no later than the later of [**] days after the effective date of termination or [**] days after AVEO’s receipt of the applicable manufacturing agreements referenced below (subject to any applicable confidentiality restrictions), Schering-Plough shall be responsible for:
Manufacturing Matters. Subject to (x) Calithera Patent Rights (which shall be licensed pursuant to Section 12.5(e) below) and (y) Calithera’s proprietary information and systems developed independently of this Agreement, subject to applicable agreements or legal obligations including to clinical sites, patients, institutional review boards, or third-party vendors, provided that Calithera may keep a copy of all documents for its records or a sample of any materials:
Manufacturing Matters. Deliver and transfer to XXXXX or its designee possession and ownership of all technology used solely in connection with the manufacture of the Licensed Products, solely for use in connection with the manufacture of the Licensed Products. At XXXXX’x option, PFIZER agrees to sell, at PFIZER’s full cost, bulk active substance for Licensed Products (provided, such meets PFIZER’s release specifications) then on hand and/or raw materials (provided, such meets PFIZER’s release specifications) used for the processing of Licensed Products for which PFIZER has no other use; provided, however, PFIZER shall not be obligated to sell any such bulk active substance or raw materials if PFIZER, in its reasonable judgment, believes that continued use or sale of such Licensed Products by XXXXX involves reasonable safety concerns. XXXXX shall be fully responsible for its use of such raw materials and bulk active substances and shall fully indemnify PFIZER for all Losses relating thereto resulting from any claims or actions of Third Parties.
Manufacturing Matters. In order to assist the Designated Regulatory Party, the Manufacturing Lead will prepare [*] in English for the relevant Product, and the Designated Regulatory Party will modify as appropriate such module for use in Regulatory Filings in the Collaboration Territory. The Manufacturing Lead will have the option, in order to protect proprietary manufacturing information, to take over operational responsibility from the Designated Regulatory Party for some or all correspondence and for specified official communications, including the preparation and submission of all Regulatory Filings required to be filed with any Governmental Authority in the Collaboration Territory with respect to the manufacture of a Product (except to the extent such transfer of operational responsibility is prohibited by Applicable Law or a Governmental Authority). With respect to any such correspondence and communication, each Party will promptly provide the other with copies of material written correspondence as reasonably necessary to permit each Party to comply with its relevant regulatory obligations or as otherwise reasonably requested; provided, that the Manufacturing Lead will not be required to disclose proprietary or competitively sensitive information unless such disclosure is required by Applicable Law.
Manufacturing Matters. At Quark’s option, to be exercised no later than [ * ] after the effective date of termination,
Manufacturing Matters. Promptly following receipt of PTC’s written notice that it intends to continue development and commercialization of Compounds and Products, Roche shall:
Manufacturing Matters. Prior to completion of the Technology and Process Transfer, Translate Bio will prepare CMC Module 3 of the Common Technical Document in English for Products, at Sanofi’s expense, and Sanofi will modify as appropriate such module for use in its Regulatory Filings. “Common Technical Document” means the set of specifications for the application of a dossier for the registration of medicines formatted according to the International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use
Manufacturing Matters. Each party shall promptly inform each other party in the event that it becomes aware of any matters which might reasonably be expected to have an adverse impact on the ability to supply trade Product to wholesalers or other customers within [***] ([***]) days of any specified delivery date. Notwithstanding the generality of the foregoing, Santarus agrees to notify S2 and VeroScience within [***] ([***]) hours after Santarus has become aware of any event or circumstance related to the manufacture of the Product that would reasonably be expected to impact the safety or efficacy of Product that has been released for commercial distribution or that would reasonably be expected to cause such released Product to be adulterated or misbranded within the meaning of the Act.
Manufacturing Matters. Any one or more of the following:
