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. Upon the successful completion of all Milestones under a TDP, as determined by the JSC:
(a) Ginkgo shall present the JSC with a reasonable number of candidate Collaboration Strains for Manufacturing the Target Cannabinoid of the completed TDP. The JSC will select one (1) Collaboration Strain, from the candidates presented, to be transferred in accordance with Section 7.1(a). Ginkgo shall transfer the selected Collaboration Strain, in accordance with Section 2.8(c). For greater clarity, only one Collaboration Strain will be required to be transferred per successful TDP, unless otherwise agreed to by the Parties.
(b) Cronos shall select one or more Third Party manufacturers, Cronos itself, or one of Cronos’ Affiliates to Manufacture and Commercialize each Cronos Product from a Collaboration Strain transferred pursuant to 2.4(a). Cronos shall bear all costs associated with (1) the Manufacture of Target Cannabinoids that are the subject of any completed TDPs and (2) Commercialization of Cronos Products.
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:
(a) Ginkgo shall present the JSC with a reasonable number of candidate Collaboration Strains for Manufacturing the Target Cannabinoid of the TDP. The JSC will select [Redacted – Commercially Sensitive Information] Collaboration Strains, from the candidates presented, to be transferred in accordance with Section 2.8(c). For greater clarity, (i) [Redacted – Commercially Sensitive Information] Collaboration Strains may be transferred per Equity Milestone Event relating to a TDP, unless otherwise agreed to by the Parties and (ii) the transfer of Collaboration Strain(s) pursuant to clause (x) of Section 2.4 with respect to a TDP will not terminate the ongoing Development activities under such TDP. Notwithstanding anything to the contrary in this Agreement, within six (6) months following the selection of Collaboration Strain(s) for Manufacturing the Target Cannabinoid of a TDP pursuant to clause (y) of Section 2.4, such Collaboration Strain(s) shall replace any other selected Collaboration Strain(s) earlier selected by the JSC pursuant to clause (x) of Section 2.4 for such TDP and such formerly selected Collaboration Strain(s) shall no longer be “Collaboration Strain(s)” under this Agreement or deemed to be a Collaboration Strain selected under this Section 2.4(a). With respect to Collaboration Strains, Cronos is solely permitted to maintain (1) seed banks of all Collaboration Strains selected and not replaced under this Section 2.4(a) and (2) an archival copy of all current and former Collaboration Strains, including in the case of clause (2), all Collaboration Strains replaced by a subsequent selection, in each case clause (1) and (2), for record-keeping purposes.
(b) Cronos shall select one or more manufacturers, which may include one (1) or more Third Parties, Ginkgo, Ginkgo Affiliates, Cronos itself, or Cronos Affiliates, to Manufacture and Commercialize each Cronos Product from a Collaboration Strain transferred pursuant to Section 2.4(a). If Cronos selects Ginkgo or a Ginkgo Affiliate to perform any Manufacturing services related to a Cronos Product, such services will be governed by the applicable Work Order, provided that if th...
Manufacturing and Commercialization. Unless otherwise agreed to by the Parties in writing, Ventrus will be solely responsible for the Manufacturing of all Ventrus Products. Licensor shall provide Manufacturing-related assistance to Ventrus as reasonably requested by Ventrus and agreed by Licensor (such agreement not to be unreasonably withheld), provided that Ventrus agrees to compensate Licensor in accordance with Section 6.4 with respect to such assistance. Ventrus shall have sole control and final decision-making authority and, together with its Affiliates, responsibility, at its own expense, for the Commercialization of Ventrus Products and Ventrus Therapies in the Territory, including planning and implementation, distribution, booking of sales, pricing, and reimbursement.
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. 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. 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. 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. 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.
5.2 BioMedicines shall have the exclusive right, but not the obligation, at its sole option and in its sole discretion, to select, choose, create or develop Other Intellectual Property Rights for any and all Licensed Products unless the rights granted hereunder to BioMedicines revert to Xxxxxx.
5.3 BioMedicines shall use its good faith efforts to develop, obtain regulatory approval and commercialize the Licensed Product in the Field in each country of the Territory where such good faith efforts would be justified by sound business judgment and shall require any Affiliates and/or Sublicensees to agree to be bound substantially by this obligation. BioMedicines shall take such actions as are reasonably necessary or customary to obtain and maintain the authorization and/or ability to market the Licensed Product in such countries in the Territory in which BioMedicines shall choose to introduce the Licensed Product. BioMedicines shall bear sole responsibility for all expenses of such development, commercialization and regulatory compliance. In the event that BioMedicines does not make such good faith efforts to pursue the development and commercialization of the Licensed Product, all rights granted hereunder shall revert to Xxxxxx, or in the event that an Affiliate or Sublicensee of BioMedicines shall not make good faith efforts to pursue the development and commercialization of the Licensed Product, all rights granted by BioMedicines to such Affiliate or Sublicensee shall revert to Xxxxxx unless BioMedicines agrees to re-assume responsibility for development and commercialization on behalf of the Sublicensee.
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.