Manufacturing and Commercialization. 7.1 Wyeth-Ayerst Development. Wyeth-Ayerst will, directly and/or through Third Parties, use Commercially Reasonable Efforts to complete the preclinical development, conduct, fund and make all decisions regarding the clinical development of Collaboration Products. Wyeth-Ayerst will have complete control, authority and responsibility for the regulatory strategies adopted for the clinical development of all Collaboration Products and will own all Regulatory Filings and Regulatory Approvals relating to any Lead Compound or Collaboration Product.
Manufacturing and Commercialization. 6.1 Definitions Relevant to Manufacturing and Commercialization Obligation. The parties intend that the Ultrio Assay Product falls within the following provisions of the Agreement:
Manufacturing and Commercialization. 5.1 BioMedicines will be solely responsible, as between BioMedicines and Xxxxxx, for manufacturing of the Licensed Product from Compound unless the rights granted hereunder to BioMedicines revert to Xxxxxx.
Manufacturing and Commercialization. 6.1 Definitions Relevant to Manufacturing and Commercialization Obligation. The parties intend that the WNV Assay Product falls within the following provisions of the Agreement:
Manufacturing and Commercialization. 5.1 Manufacturing Facility. CureVac shall plan and carry out the completion of the installation and Regulatory Approval of the GMP-IV Manufacturing Facility, with two Drug Substance production lines each with a targeted scale up of five times compared to the current production process established at the GMP-III Manufacturing Facility and targeting a Drug Substance batch size of [*****] and the production of [*****] per year, at its own cost, due for completion by the Initiation of the [*****]. Furthermore, CureVac shall use Diligent Efforts to complete by the same date: (i) in-sourcing and process development of the Drug Product formulation process, including the LNP Technology; (ii) in-sourcing of the capability to produce DNA plasmids using the pDNA technology; and (iii) development of the supply chain for sourcing critical raw materials (the "Manufacturing Facility Enhancements"); provided that if the Parties agree in good faith that a CMO would be better suited to perform any of the activities under (i) and (ii), GSK shall relieve CureVac from its obligations with respect to (i) and/or (ii), as applicable, and provided further that the only and exclusive remedy in case of a breach by CureVac of its obligations to use Diligent Efforts to complete the Manufacturing Facility Enhancements under this Section 5.1 shall be that CureVac covers the costs for a bridging study in humans, if required solely as a result of such breach by CureVac, in the maximum amount of EUR 3,000,000. Subject to Section 5.2, up to once per quarter, GSK shall have the right to request and assess the plans proposed by CureVac regarding the foregoing and to monitor the progress, provided that, if and to the extent it is necessary for GSK to undertake an on-site visit for this purpose, GSK shall not be permitted to do so more than twice per Calendar Year. GSK may, where relevant and at its discretion, suggest appropriate improvements and provide additional support in connection with enhancement of the Manufacturing Process for Drug Product and the installation of the GMP-IV Manufacturing Facility, which CureVac may freely decide to implement or not. CureVac will reasonably consider to use the [*****] for the Manufacture of the Products; it being understood and agreed between the Parties that GSK may not request the disclosure of any Know-How or any technology transfer from CureVac with respect to the [*****] other than to the extent necessary for any Regulatory Filing for a Product.
Manufacturing and Commercialization. Tracon shall have the responsibility for, and shall bear all costs for, the manufacture of Products and, following approval to commence marketing of a Product in a country in the Territory, the commercialization activities for the Product in the Territory. Tracon shall use commercially reasonable efforts to commercialize and fill market demand for Products in each country in the Territory. To the extent required under the USC Agreement and the requirements of the Bxxx-Xxxx Act, Products used or sold in the United States shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from the relevant U.S. federal agency. Tracon shall perform, and shall ensure that its Affiliates, sublicensees, and third party contractors perform its research, development, preclinical, clinical, manufacturing and commercial activities under this Agreement in compliance with applicable laws, rules, and regulations.
Manufacturing and Commercialization. Where, as determined by the JSC, (x) Development under a TDP for a Target Cannabinoid has progressed such that an Initial Equity Milestone Event relating to that Target Cannabinoid is likely to soon occur or (y) the successful completion of all R&D Milestones and Other Equity Milestone Events under a TDP is likely to soon occur:
Manufacturing and Commercialization. Pursuant to the licenses granted to Wyeth in Section 3.1, Wyeth shall have the exclusive right to (a) Manufacture, itself or through Third Parties selected by Wyeth or both, Products, and (b) Commercialize, itself or through Third Parties selected by Wyeth or both, Products (including all ingredients and components thereof). Wyeth shall notify SCOLR prior to having any Third Party Manufacture Product. Wyeth shall have sole authority and responsibility in all matters relating to the Manufacture and Commercialization of Products; provided, however, Wyeth shall use Commercially Reasonable Efforts to Commercialize at least one (1) Licensed Product in those countries where Wyeth has obtained Regulatory Approval for such Product. Wyeth shall have no other diligence obligations with respect to the Manufacture or Commercialization of Products.
Manufacturing and Commercialization. FPI shall control and be solely responsible for the Manufacturing and Commercialization of all of its Products, at its sole cost and expense.
Manufacturing and Commercialization. Upon the successful completion of all Milestones under a TDP, as determined by the JSC:
