Process Development; Manufacturing Approvals Sample Clauses

Process Development; Manufacturing Approvals. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team. The Parties will use commercially reasonable and diligent efforts, and will cause any approved Third Party supplier, to make filings necessary to obtain approval of any license application for the New Facility which may be required as part of any Regulatory Approval for the first Collaboration Product.
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Process Development; Manufacturing Approvals. The continued development of the process for the manufacture of Collaboration Compounds and Collaboration Products as well as the scale up of that process and all material issues incident to the development to produce Collaboration Products for commercial purposes in the Shared Territory in sufficient quantity and in a timely manner will be overseen by the Joint Development Committee. Acucela and Otsuka will use Commercially Reasonable Efforts to make necessary filings to obtain, or to cause a Third-Party manufacturer of Collaboration Compounds and/or Collaboration Products to make necessary filings to obtain, Regulatory Approval for the manufacture of Collaboration Compounds and Collaboration Products as part of the Regulatory Approval to market each Collaboration Product in the Shared Territory. If applicable, such filings shall include the filing and maintenance of a Drug Master File with the FDA and the equivalent thereof in the other countries in the Shared Territory in which the Parties seek Regulatory Approval of Collaboration Products. Once such filings are made, no changes to the process for the manufacture of Collaboration Compounds and Collaboration Products for the Shared Territory shall be made without the prior written approval of both Parties.
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Process Development; Manufacturing Approvals. BioSearch will use [*] efforts to develop a process for the manufacture of Bulk Licensed Compounds according to the specifications therefor and to scale up that process to a scale sufficient to manufacture and supply IntraBiotics' anticipated requirements for clinical and commercial supply of Licensed Products. BioSearch will use [*] efforts to make necessary filings to obtain, or to cause a Third Party manufacturer of Bulk Licensed Compounds to make necessary filings to obtain, Regulatory Approval for the manufacture of Bulk Licensed Compounds as part of the approval of a Drug Approval Application for each Licensed Product in the Field and in the Territory.
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Process Development; Manufacturing Approvals. CTI will -------------------------------------------- use commercially reasonable and diligent efforts to develop a process for the manufacture of Collaboration Compounds and to scale up that process to a scale sufficient to manufacture and supply the anticipated demand for Collaboration Compounds. The continued development of the process for the manufacture of Collaboration Compounds as well as the scale up of that process and all material issues incident to the development to produce Collaboration Compounds for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the JDC. The costs associated with the development and scale up of a process to manufacture Collaboration Compounds will be a Development Expense. Subject to ORTHO's rights and obligations under Section 4.07(b), CTI will use commercially reasonable and diligent efforts to make necessary filings to obtain, or to cause a Third Party manufacturer of Collaboration Compounds to make necessary filings to obtain Regulatory Approval for the manufacture of Collaboration Compounds as part of the approval of a Drug Approval Application for each Collaboration Product in the Co-Promotion Territory. Such filings shall include the filing of a Drug Master File in the United States and the equivalent thereof in the Major Market Countries. Once such filings are made, no changes to the process for the manufacture of Collaboration Compounds shall be made without the prior written approval of ORTHO.
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Process Development; Manufacturing Approvals. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale-up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for pre-clinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team.
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Process Development; Manufacturing Approvals. Biosearch will use diligent efforts to develop a process for the manufacture of Bulk Licensed Compounds according to the Specifications therefor and to scale up that process to a scale sufficient to manufacture and supply GENE's anticipated requirements for clinical and commercial supply of Licensed Products. Biosearch will use diligent efforts to make necessary filings to obtain, or to cause a Third Party manufacturer of Bulk Licensed Compounds to make necessary filings to obtain, Regulatory Approval for the manufacture of Bulk Licensed Compounds as part of the approval of a Drug Approval Application for each Licensed Product in the Field and in the Territory. Should Biosearch be unable to obtain Regulatory Approval for the manufacturing process and facility of Bulk Licensed Compound, then GENE shall have the right to contract with a Third Party for the Regulatory Approval of a manufacturing process and facility and manufacture and supply of its requirements of Bulk Licensed Compound under the terms and conditions of Section 7.2. ---------- *Confidential Treatment has been requested for the marked portions.
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Process Development; Manufacturing Approvals. SCHERING will use -------------------------------------------- commercially reasonable efforts to develop or have developed a process for the manufacture of Human Therapeutic Products and to scale up that process to a scale sufficient to manufacture and supply the anticipated demand for Human Therapeutic Products. The costs associated with the continued development of the process for the manufacture of Human Therapeutic Products as well as the scale up of that process and all material issues incident to the development of Human Therapeutic Products for commercial purposes will be a Development expense. SCHERING will use commercially reasonable efforts to make necessary filings to obtain, or to cause a Third Party manufacturer of Human Therapeutic Products to make necessary filings to obtain Regulatory Approval for the manufacture of Human Therapeutic Products as part of the approval of a Drug Approval Application for each Co-Promotion Product in the Co-Promotion Territory.
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Process Development; Manufacturing Approvals. Cyberkinetics shall be primarily responsible for and will use Commercially Reasonable and Diligent Efforts to develop a process for the manufacture of each prototype device for research activities of the Program and for each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (i) the anticipated demand for clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (ii) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of Cyberkinetics but may be outsourced to a Third Party if approved in writing in advance by the Steering Committee. Cyberkinetics will use Commercially Reasonable and Diligent Efforts to make, and will cause any Third Party manufacturer or supplier to make, filings necessary to obtain approval of any license application for the production facility which may be required as part of any Regulatory Approval for each Collaboration Product. Any plans for a production facility for the manufacture of Collaboration Products for commercial sale shall be approved by the Steering Committee prior to commencement of any manufacturing.
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Process Development; Manufacturing Approvals. Abgenix will use Commercially Reasonable and Diligent Efforts to develop or have developed on its behalf a process for the manufacture of bulk Licensed Product and to scale up that process to a scale sufficient to manufacture and supply the demand for Licensed Products anticipated in the Initial Development Outline. Abgenix will use Commercially Reasonable and Diligent Efforts to make necessary filings to obtain, or to cause a Third-Party manufacturer of Licensed Products to make necessary filings to obtain, Regulatory Approval for the manufacture of Licensed Products as part of the approval of a Drug Approval Application for the Licensed Product and to permit SangStat to reference such manufacturing Regulatory Approvals in its Drug Approval Application for the Licensed Products. Such filings shall include the filing of a Drug Master File in the United States and the equivalent thereof in the other countries of the world in which the Parties seek Regulatory Approval of Licensed Products. Once such filings are made, no changes to the process for the manufacture of Licensed Product shall be made that would require approval of the relevant Regulatory Authority without the prior written approval of both Parties. Auditing Rights. No more than once per twelve-month period, SangStat shall have the right upon thirty (30) days prior written notice to audit and inspect the manufacturing facility and the production and quality control areas, related departmental and Licensed Product documentation to ensure compliance with cGMP and to confirm that the Licensed Product is being manufactured and tested in accordance with the terms of this Agreement. If an audit reveals significant concerns, then SangStat shall have the right to conduct a follow-up audit within the same twelve-month period. Regulatory Authority Inspections. In addition, SangStat will be informed immediately by telephone of any process exceptions (whether or not authorized in advance by SangStat), which exception would be reportable under the reporting requirements to a Regulatory Authority and all Regulatory Authority inspections or notices concerning any Licensed Product or the facility. Abgenix shall notify SangStat promptly of any and all changes of its regulatory status, resulting from a site inspection or any other action from any Regulatory Agency. Abgenix shall provide SangStat with copies of any reports, citations or other materials relating to such inspections and which relate, directly or indir...
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Related to Process Development; Manufacturing Approvals

  • Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

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