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. VBI shall manufacture, store, and transfer the Licensed Product supplied pursuant to Sections 7.1 and 7.2 in accordance with the terms and conditions set forth in a separate Supply Agreement. For the avoidance of doubt, VBI shall not be obligated to supply pursuant to this Section 13.2 until the Parties executed and enter into such separate Supply Agreement.
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. 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. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”
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. 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).
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. 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.
Manufacture of Licensed Product on behalf of GSL. GSL shall, at its sole discretion, cost and expense, manufacture or have manufactured Licensed Product for Regulatory Approval and Commercialization of the Licensed Product in the Territory within the Field of Use. Upon the assignment of Supply Agreement to GSL, GSL shall procure its supply of Licensed Product from in accordance with the terms of Supply Agreement or any other Third Party contracted by GSL for which GSL obtains Regulatory Approval.
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. EXECUTION COPY [***]) and indirect costs (including [***]) specifically [***] of the Licensed Product.
