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 (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 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 Dedicated Facility which may be required as part of any Regulatory Approval for the first Collaboration Product.
Sample 1Sample 2See All (4)
AutoNDA by SimpleDocs
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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1Sample 2
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.
Sample 1
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...
Sample 1
AutoNDA by SimpleDocs
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.
Sample 1
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.
Sample 1

Related to Process Development; Manufacturing Approvals

  • Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • 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.

  • Joint Manufacturing Committee In accordance with Section 2.5(c)(iv), the Parties shall promptly establish and convene a joint Manufacturing Committee (the “JMC”) for the overall coordination and oversight of the Manufacturing of clinical and commercial supplies of the Product under this Agreement as provided in the Manufacturing Plan (including the Manufacture of API, Drug Product and Finished Product). The JMC shall consist of representatives of each Party, and shall operate by procedures, as set forth in Section 2.5. The role of the JMC shall be:

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.