Manufacture of Licensed Product. To enable Licensee to perform FFF Manufacture of Licensed Product. Licensor will transfer the FFF Manufacture process to Licensee and its CMO for the purpose of implementing the FFF Manufacture process only. [***].
Manufacture of Licensed Product. Licensee shall be responsible for manufacturing and supplying Licensed Products in the Territory by itself or through a Third Party manufacturer for Commercial sale of Licensed Product following receipt of Regulatory Approval on a country-by-country basis in the Territory. Supplies for human Clinical Trials and related program required for Regulatory Approvals in the Territory shall be manufactured in accordance with current cGMP standards.
Manufacture of Licensed Product. VBI shall manufacture, store, and transfer the Licensed Product supplied pursuant to Article 7 in accordance with applicable Licensed Product specifications and all Applicable Laws, including GMP. For the avoidance of doubt, VBI shall not be obligated to supply pursuant to this Section 13.3 until the Parties executed and enter into the Supply Agreement.
Manufacture of Licensed Product. 7.4.1. Newsoara shall, at its own expense, be solely responsible for the Manufacture and supply of the Licensed Compound and Licensed Product in the Territory, either by itself or through its Affiliates, its and their Sublicensees or Third Party contract manufacturers, and all related tasks, obligations, and responsibilities (including but not limited to filling, finishing, packaging, labelling, testing, sample retention, auditing, quality assurance, and the like). In pursuit of their Development, regulatory and Commercialization activities in accordance with Applicable Law in the Territory, either by itself or through its Affiliates, its and their Sublicensees or Third Party contract manufacturers, Newsoara shall use Commercially Reasonable Efforts to provide sufficient quantities to meet market demand for the Licensed Compound and Licensed Product in the Territory.
7.4.2. Newsoara shall Manufacture clinical supply (including but not limited to any stability and validation batches) and commercial supply batches of the Licensed Compound and Licensed Product in accordance applicable Laws and Regulatory Approvals, including without limitation cGMP (including without limitation, the cGMP requirements concerning documentation, reports and record keeping) and in accordance with the applicable specifications and requirements.
7.4.3. In the event that AUM requests Newsoara to provide either clinical supply or commercial supply batches of the Licensed Compound and Licensed Product made in the Territory for use outside of the Territory and Newsoara, at its sole discretion, agrees to do so, both Parties shall negotiate a mark-up price for such clinical or commercial supply batches of the Licensed Compound and Licensed Product, and enter into a separate supply agreement in good faith.
7.4.4. Upon Newsoara’s request, AUM shall promptly (and in no event, later than 30 days after said request) transfer to Newsoara or its designee any AUM Product Know-How relating to Manufacture of the Licensed Compound and the Licensed Product, and provide any assistance (including on-site assistance) reasonably required to ensure an orderly transfer of the relevant manufacturing processes, without additional charge. During any such transfer, AUM shall also make available its qualified technical personnel on a reasonable basis to consult with Newsoara or its designee with respect to such AUM Product Know-How. Newsoara shall bear the travel and lodging expenses of such AUM personnel, inc...
Manufacture of Licensed Product. Pulmatrix shall be responsible for manufacturing and supplying Licensed Products in the Territory by itself or through a Third Party manufacturer for Commercial sale of Licensed Product following receipt of Regulatory Approval on a country-by-country basis in the Territory. Supplies for human Clinical Trials and related program required for Regulatory Approvals in the Territory shall be manufactured, as needed, in accordance with current cGMP standards.
Manufacture of Licensed Product. Actelion will Manufacture, or arrange with Third Parties for the Manufacture of Kythera’s requirements of the Licensed Product as bulk packaged drug product, i.e., bulk tablets of [***] dose and matching placebo(s), excluding finished packaging for the Proof of Concept Trial. As part of such Manufacture, Actelion and Kythera and/or Third Parties agree to enter into a Quality Agreement, and Actelion will provide the documentation to enable Kythera’s regulatory and quality function to test and release all supplies of such Licensed Product for such Proof of Concept Trial (if applicable). The cost of such Manufacturing will be at a price equal to [***] for such Licensed Product. [***] shall mean the [***] and [***] (including [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. [***]) and indirect costs (including [***]) specifically [***] of the Licensed Product.
Manufacture of Licensed Product. Centocor shall be responsible for manufacturing and supplying Licensed Products in the Territory by itself or through a Third Party manufacturer. Supplies for human clinical trials and commercial supplies of Licensed Product shall be manufactured in accordance with CGMP standards. Centocor shall use commercially reasonable efforts to achieve the lowest Manufacturing Cost that it can achieve while maintaining J&J quality control, safety and labor standards.
Manufacture of Licensed Product. NovaDel will Manufacture Licensed Product in accordance with the Specifications, cGMPs and other applicable rules and regulations of the EMEA or other applicable Regulatory Authorities in the Territory. The parties shall notify each other within forty-eight (48) hours of any new instructions or specifications required by the FDA (if applicable), EMEA and by other applicable Regulatory Authorities in the Territory. The parties shall confer with each other with respect to any response regarding such instruction or specification and the best means to comply with such requirements and the parties will bear the costs for implementing such changes in accordance with Section 7.4.
Manufacture of Licensed Product. VBI shall manufacture, store and transfer the Licensed Product supplied pursuant to Section 7.1(a) (and Schedule 7.1(a)) in accordance with applicable Licensed Product specifications and all Applicable Laws, including GMP.
Manufacture of Licensed Product. Subject to Section 3.2.2, Licensee shall have the sole responsibility for, at its expense, Manufacturing (or having Manufactured) and supplying the Licensed Compound and the Licensed Product for their Development and Commercialization activities in accordance with Applicable Law in the Territory, either by itself or through its Affiliates, its and their Sublicensees or Third-Party contract manufacturers. Notwithstanding the foregoing, AstraZeneca agrees to, at Licensee’s cost, supply to Licensee with inventory of the Licensed Product (whether in the form of drug tablets or drug substance) in accordance with the Transition Plan at AstraZeneca’s [***]. Such supply shall include all appropriate documentation including accurate certificates of analysis and any release documentation. The Parties shall execute a quality agreement to set forth the Parties’ respective responsibilities with respect to quality matters relating to supply and compliance with cGMP (the “Quality Agreement”) [***] of the Effective Date. In the event of any conflict between the Quality Agreement and this Agreement, the terms of the Quality Agreement shall control all quality matters. Further terms applicable to such supply are set forth in Schedule 3.2.1 (Transition Plan).
