Manufacturing Development. Santaris shall use Diligent Efforts to develop or have developed a suitable formulation of each LNA Monomer necessary for the manufacture of each Selected LNA Compound and Product and to develop scale-up and validation procedures for the manufacture of commercial quantities of each LNA Monomer and conduct such other manufacturing development work as is reasonably necessary to manufacture quantities of each LNA Monomer necessary for the manufacture of each Selected LNA Compound and Product, including formulation and stability development and process validation. If Santaris licenses or otherwise engages a Third Party to manufacture and sell LNA Monomers (other than as a contract manufacturer solely for Santaris), Santaris shall allow Enzon to contract with and receive supply directly from any such Third Party.
Manufacturing Development. Enzon shall use Diligent Efforts to develop or have developed a suitable formulation of each Selected LNA Compound and Product and to develop scale-up and validation procedures for the manufacture of quantities of each Selected LNA Compound and Product and conduct such other manufacturing development work as is reasonably necessary to manufacture quantities of each Selected LNA Compound and Product, including formulation and stability development and process validation. If Enzon engages a Third Party to manufacture and supply a Selected LNA Compound or Product (other than as a contract manufacturer solely for Enzon), Enzon shall allow Santaris to contract with and receive supply directly from any such Third Party.
Manufacturing Development. Development of manufacturing processes and systems in conformance with cGMP requirements of FDA to manufacture pilot batches, exhibit batches and commercial batches of Product.
Manufacturing Development. Enzon shall use Diligent Efforts to develop or have developed a suitable formulation of Products for commercial sale worldwide and to develop scale-up and validation procedures for the manufacture of commercial quantities of Products and conduct such other manufacturing development work as is reasonably necessary to manufacture and package commercial quantities of Products, including formulation and stability development and process validation.
Manufacturing Development. Alkermes shall conduct Manufacturing development for the Product to reduce Manufacturing cost and enhance Manufacturing output. The ST shall submit a plan and budget for such Manufacturing development to the DT, which in turn shall incorporate this plan into the Development Plan submitted to the JSC for review and approval. Such plan and budget shall be consistent with, and reasonably calculated to enable Alkermes to perform, its obligations pursuant to Section 3.15. Alkermes shall then conduct Manufacturing development in accordance with the Development Plan and budget approved by the JSC.
Manufacturing Development. All Manufacturing Development of the Products that incorporate the Lead Compound shall be handled as further set forth in Article 7.
Manufacturing Development. The Manufacturing Plan shall allocate to Takeda and Ovid those aspects of Manufacturing and Packaging as are set forth in the Manufacturing Plan.
Manufacturing Development. The Parties acknowledge and agree that [***]. BI shall work towards [***] during the course of the Phase I Clinical Trial and Phase IIa Clinical Trial. Zealand Pharma will provide any support for this process that BI may reasonably request, as part of the Research Collaboration or, if not included in the Research Plan, with compensation for Zealand Pharma internal and external costs to be negotiated in good faith. Without limitation on its other rights under this Agreement, BI shall review [***] at the time that the Phase IIa Clinical Trial data for the Product(s) becomes available, and shall notify Zealand Pharma if BI determines that it is likely to terminate further development of the Product(s) and reply to Zealand Pharma’s reasonable requests for information concerning the formulations and manufacturing procedures considered by BI. Should either Party so request, [***] shall be discussed at a meeting of the Executive Representatives of the Parties held within thirty (30) days after receipt by Zealand Pharma of the notice described above, and prior to BI exercising its right to terminate this Agreement under Section 15.5.
Manufacturing Development. The Parties acknowledge and agree that [***]. BI shall work towards [***]. Zealand Pharma will provide any support for this process that BI may reasonably request, as part of the Research Collaboration or, if not included in the Research Plan, [***]. Without limitation on its other rights under this Agreement, BI shall review the anticipated cost of goods of Product(s) at the time that the Phase IIa Clinical Trial data for the Product(s) becomes available, and shall notify Zealand Pharma if BI determines that it is likely to terminate further development of the Product(s) and reply to Zealand Pharma’s reasonable requests for information concerning the formulations and manufacturing procedures considered by BI. Should either Party so request, [***] shall be discussed at a meeting of the Executive Representatives of the Parties held within thirty (30) days after receipt by Zealand Pharma of the notice described above, and prior to BI exercising its right to terminate this Agreement under Section 15.5. [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions.
Manufacturing Development. IRC will be responsible for process development, qualification and provision of all preclinical and Phase I and II clinical material in a manner consistent with the objectives outlined above (section A. 2.). Bayer will be responsible for provision of all Phase III materials and commercial scale production of the candidate FVIII GeneDrug. IRC will endeavor to develop its processes and specifications in a manner which is commercially scalable, manufacturing friendly and transferable to Bayer or its sublicensee (i.e. contract manufacturer). IRC will consult with Bayer during the development of the processes and will provide support during the process transfer so that minimal impact upon initiation of the Phase III trials occurs. RESEARCH WORK PLAN FVIII Gene Therapy Research Plan IRC/Bayer Collaboration The research program for collaboration between the Immune Response Corporation (IRC) and Bayer envisions the following elements as distinct from the development program (described separately):
