Prior Manufacturing Agreements Sample Clauses

Prior Manufacturing Agreements. BMS acknowledges that Nektar, prior to the Execution Date, has (i) selected and entered into agreements with certain Third Party contract manufacturers, (ii) identified a number of Manufacturing facilities/sites and (iii) completed visits to such facilities/sites, and BMS approves of such sites, and Third Party contract manufacturers, each as set forth in Schedule 5.2(a)(iii). BMS acknowledges that the information related to such Third Party contract manufacturers and Manufacturing facilities/sites have been made available to BMS prior to the Effective Date, and subject to a satisfactory quality audit to be performed by BMS after the Effective Date in accordance with BMS’s internal SOPs, BMS will approve the continuation of the related Manufacturing agreements on their terms (including the budgets and pricing included therein), and hereby ratifies, on behalf of its appointees to the JMC and JDC, the decisions taken by Nektar prior to the Effective Date that would otherwise be under the purview of the JMC or JDC pursuant to this Agreement, solely to the extent that such decisions have been disclosed to BMS prior to the Effective Date. For any additional Third Party contract manufacturers or Manufacturing facilities/sites proposed after the Effective Date, the Manufacturing Party, after discussion with the non-Manufacturing Party, will create and provide the JMC with a proposed list of potential Manufacturing facilities/sites and Third Party contract manufacturers that may be used to Manufacture the Nektar Compounds and Product, with the final list to be subject to JMC (or JMC Co-Chairs) approval (such JMC-approved list being the “Facility List”). Except as otherwise noted in this Section 5.3(g), the proposed Facility List will be provided to the JMC prior to the Manufacturing Party initiating facility/site selection negotiations or visits. The Manufacturing Party shall have the authority to select the final Third Party contract manufacturers or Manufacturing facilities/sites from the Facility List. In the event that additional facilities/sites or Third Party contract manufacturers need to be added after the initial list is approved, a new list will be created by the Manufacturing Party that includes the proposed new facilities/sites or Third Party contract manufacturers and such list will be provided to the JMC for approval by the JMC (or JMC Co-Chairs) per this Section 5.3(g).
Sample 1
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Related to Prior Manufacturing Agreements

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • 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:

  • 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.

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

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