Collaboration Product. Each Collaboration Lead Compound shall be referred to herein as a “Collaboration Product” from and after filing of an IND in respect of such compound with the FDA or the filing of its equivalent in any foreign country other than Japan. The preparation, filing and prosecution of IND’s, NDA’s and other regulatory filings required to be filed with the FDA and its foreign equivalents (other than in Japan) in regard to any Collaboration Product will be at the sole expense of, in the name of and under the direction of Warner. Warner does not warrant that any regulatory filings will actually be filed or, if filed, will be approved.
Collaboration Product. All Collaboration Product supplied by Agila hereunder shall comply with all Applicable Laws, GMPs and meet all Specifications, and Agila shall perform and document all manufacturing and supply activities contemplated herein in compliance with all Applicable Laws.
Collaboration Product. Any Product Configuration which is unanimously approved as a Collaboration Product shall be a Collaboration Product for all purposes of this Agreement. Product Configurations which are not designated as Collaboration Products as set forth above shall not be Collaboration Products.
Collaboration Product. If [***], is sued by [***] for infringement of [***] in connection with activities relating to the manufacture, use, handling, storage, Development, Commercialization or other disposition of a [***] shall promptly notify [***] within [***] days of its receipt of notice of such suit. The notice shall set forth [***]. The Parties shall then meet to discuss [***], provided, that (a) if such infringement relates primarily to [***], then [***] shall have the first right to control such suit in close consultation with [***] and (b) if such infringement relates primarily to [***], then [***] shall have the first right to control such suit in close consultation with [***]. In no event may [***] without the express written consent of [***]. To the extent a claim is subject to [***] the procedure in [***] must be followed. Each Party will [***] for its activities which are outside the scope of this Agreement.
Collaboration Product. All Drug Products or IMPs of Collaboration Product(s) supplied by Stelis BioPharma hereunder shall comply with all Applicable Laws, GMPs and meet all Specifications, and Stelis BioPharma shall perform and document all manufacturing and supply activities contemplated herein in compliance with all Applicable Laws. [***].
Collaboration Product. The term “Collaboration Product” shall mean a product that binds to a Collaboration Target and is a Protein Degrader that includes a Protein Degrader Component that (i) was delivered by C4T to Calico pursuant to a Target Evaluation Research Plan or a Joint Research Plan for a Collaboration Target, or (ii) was delivered by C4T to Calico pursuant to a Target Evaluation Research Plan or a Joint Research Plan for a Collaboration Target and was thereafter optimized by or on behalf of Calico for such Collaboration Target, or (iii) is Covered by a Valid Claim of the Licensed Patents or Collaboration Product Patent.
Collaboration Product. If [ * ], is sued by [ * ] for infringement of [ * ] in connection with activities relating to the manufacture, use, handling, storage, Development, Commercialization or other disposition of a [ * ] shall promptly notify [ * ] within [ * ] days of its receipt of notice of such suit. The notice shall set forth [ * ]. The Parties shall then meet to discuss [ * ], provided, that (a) if such infringement relates primarily to [ * ], then [ * ] shall have the first right to control such suit in close consultation with [ * ] and (b) if such infringement [ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. relates primarily to [ * ], then [ * ] shall have the first right to control such suit in close consultation with [ * ]. In no event may [ * ] without the express written consent of [ * ]. To the extent a claim is subject to [ * ] the procedure in [ * ] must be followed. Each Party will [ * ] for its activities which are outside the scope of this Agreement.
Collaboration Product. Each Party will notify the other Party in writing if it becomes aware of any Third Party alleging that the performance of this Agreement infringes Third Party intellectual property rights (Infringement Attack). If an Infringement Attack is directed against the manufacture, use, handling, storage, Development, Commercialization or other disposition of a Collaboration Product, the Parties shall consult in good faith through the Joint IP Committee with a view to agreeing any required or desirable defense to any such Infringement Attack. Each Party shall have the right to defend itself against the Infringement Attack in accordance with the decisions and instructions of the Joint IP Committee. Notwithstanding the preceding sentence, Genmab shall be solely responsible for the defense against Infringement Attacks directed against the use of [***] Technology [***] and Biontech shall be solely responsible for the defense against Infringement Attacks directed against the use of [***] Technology [***], in both scenarios in close consultation with the other Party. In no event may a Party settle or otherwise consent to an adverse judgment that diminishes the rights or interests of the other Party without the express written consent of the other Party not to be unreasonably withheld.
Collaboration Product. If a facility is used to manufacture Collaboration Products and products for other programs of either Genzyme or GTC (including without limitation products for use or sale in the SMIG Territory), fixed costs shall be allocated in proportion to the use of such facility for the manufacture of Collaboration Products and products for such other programs. Fully Absorbed Cost of Goods shall exclude all costs otherwise reimbursed pursuant to this Agreement. In the event that either GTC or Genzyme subcontracts with the other Party to perform any work on its behalf in connection with the manufacturing responsibilities assigned to GTC or Genzyme, respectively, pursuant to Section 7.2.1 hereof, GTC and Genzyme (i) shall each directly charge ATIII LLC their respective Fully Absorbed Cost of Goods and (ii) shall not include any part of the other Party's Fully Absorbed Cost of Goods in the amount so charged to ATIII LLC. Except as otherwise provided in this Agreement, all cost determinations made hereunder shall be made in accordance with GAAP.
Collaboration Product. Except in those instances where Sections 13.5(a) and (b) expressly apply, in the event of any Losses to either Party resulting directly or indirectly from the manufacture, use, testing, handling, storage or disposition of a Collaboration Product or the inherent properties of a Collaboration Product (including without limitation product liability claims), the Parties shall share such Losses in accordance with Section 6.2(a).
