Transfer of Manufacturing Responsibility Sample Clauses

Transfer of Manufacturing Responsibility. (a) Upon written notice from Zai made any time after [*] after the Effective Date, Zai may request a technology transfer for any or all stages of the Manufacturing process of Licensed Product for which Entasis has completed Manufacturing process development (each such stage, a “Manufacturing Stage”). After receipt of any such request from Zai, Entasis shall promptly provide all assistance reasonably necessary to enable transfer of such Manufacturing Stage(s) to Zai or its designee, including (i) providing all available information relevant to such transfer, including available CMC documentation in Entasis’s control, pursuant to a written technology transfer plan as initially proposed by Entasis and mutually agreed upon by the Parties, and (ii) upon Zai’s request and at Zai’s expense, providing regulatory support to coordinate FDA inspection of Zai’s drug substance and drug product manufacturing facilities for Licensed Product by or on behalf of Zai. Zai shall reimburse Entasis’s good faith estimate of internal expenses and costs at the FTE Rate for FTEs engaged to assist Zai in connection with a Manufacturing Stage transfer initiated by Zai pursuant to this Section 7.2(a). In addition, Zai shall reimburse Entasis for all out-of-pocket expenses and costs incurred by Entasis to assist Zai in connection with such Manufacturing Stage transfer. Entasis shall invoice Zai on a [*] basis for [ ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. the foregoing costs incurred by Entasis, and Zai shall pay the amount invoiced within [*] after the date of any such invoice.
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities or, if selected by Agios pursuant to Section 4.1(b), the Agios Commercial-Scale Manufacturing Responsibilities, Agios shall (a) transfer, or have transferred, to Celgene or its designee, pursuant to a technology transfer plan to be mutually agreed by the Parties, all Manufacturing Technology Controlled by Agios or AIS and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities or, if selected by Agios pursuant to Section 4.1(b), the Agios Commercial-Scale Manufacturing Responsibilities, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. Costs incurred by either Party in such transfer shall be Development Costs.
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities, Vividion shall (a) transfer, or have transferred, to Celgene or its designee all Manufacturing Technology Controlled by Vividion and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities and use Commercially Reasonable Efforts to complete such transfer within [***] days after the Effective Date, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. The Out-of-Pocket Costs incurred by Vividion in connection with such transfer shall be reimbursed by Celgene within [***] days after receipt by Celgene of an invoice for such costs.
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Transfer of Manufacturing Responsibility. The Manufacturing Agreement shall set forth, among other things, the procedures for the transfer of Marketed Product manufacturing responsibility to Advancis or its designee.
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Transfer of Manufacturing Responsibility. (a) ****** after the Effective Date the Parties shall commence, and diligently pursue, the transfer of responsibility for manufacturing Collaboration Compounds and bulk Covered Products from OXiGENE to BMS. Each Party shall designate a liaison to implement such transfer process and coordinate it with the performance of such Party's other obligations under this Agreement. The Parties shall use commercially reasonable efforts to complete such transfer as expeditiously as possible. In connection with such transfer OXiGENE shall assign to BMS any Third Party contracts into which OXiGENE has entered regarding such manufacturing that BMS requests to be assigned and that may be so assigned. OXiGENE shall use reasonable commercial efforts to obtain any necessary Third Party consents in connection with any such assignments.
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Transfer of Manufacturing Responsibility. At any time on or [***], Catalyst shall have the right, itself or through any Third Party manufacturer, to Manufacture the Compound and the Product in or outside the Territory for purposes of Development, filing for and obtaining Regulatory Approval and Commercializing the Compound and the Products in the Field in the Territory. Catalyst shall give written notice to Santhera of its election to so Manufacture the Compound and the Product and, upon such written notice, (a) the Manufacturing License shall automatically go into effect, (b) the Parties, through the JSC, shall discuss and agree upon a schedule and plan for transition of the Manufacture of the Compound and the Product for the Territory to Catalyst or its Third Party manufacturer(s), including a technology transfer plan, and (c) if requested by Catalyst, the Parties will use good faith efforts to implement assignments to Catalyst of Santhera’s agreements with its Third Party manufacturers (“CMO”) to the extent applicable to Manufacture and supply of the Compound and the Product for the Territory, provided that Santhera’s agreements with its relevant CMO may remain in place, at Xxxxxxxx’s discretion, to the extent applicable to Manufacture and supply of the Compound and the Product for territories other than the Territory. Without limiting the foregoing, for any such CMO agreement that is not assignable (without the consent of the CMO or otherwise), Santhera will make a good faith effort to obtain consent from the applicable CMO or to otherwise enable the assignment of such agreement to Catalyst to the extent applicable to Manufacture and supply of the Compound and the Product for the Territory. In addition, Santhera and Catalyst shall provide reasonable assistance and cooperation in connection with the transition of the Manufacture of the Compound and Product to Catalyst or its Third Party manufacturers (including, if applicable, CMOs), including implementing the agreed-upon technology transfer plan, in accordance with such schedule agreed upon by the Parties, which assistance shall include: (i) providing an introduction to Santhera’s CMO(s) or other Third Party manufacturers for Compound and Product and facilitating negotiations with such entities; (ii) granting any authorizations reasonably requested by Catalyst or its CMOs or other Third Party manufacturers in connection with the Manufacture of the Compound and Product for the Territory; and (iii) transferring to Catalyst and its CMOs or other ...
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Transfer of Manufacturing Responsibility. Subject to the last sentence in Section 5.4 (Transfer of Manufacturing Know-How), Partner will have the right to assume responsibility for Manufacturing the Licensed Products for use in the Field in the Territory pursuant to the Manufacturing Responsibility Transfer Plan, which right it may exercise at any time during the Term by providing written notice to uniQure (the date of such notice, the “Manufacturing Responsibility Transfer Notice Date”). In such notice, Partner will (a) elect to Manufacture all or part of Partner’s requirements for the Licensed Products (i) through the CMO(s) then engaged by uniQure, in which case uniQure will transfer or assign to Partner all applicable agreements between uniQure and such CMO (if and to the extent that such agreement is transferrable or assignable and relates solely to the Licensed Products) or Partner may enter into its own direct agreement with such CMO, (ii) itself, in which case uniQure will transfer the uniQure Manufacturing Know-How to Partner in accordance with Section 5.4 (Transfer of Manufacturing Know-How), or (iii) through a CMO designated by Partner (subject to approval of such CMO by uniQure if required by and in accordance with Section 2.2.2 (Right to Subcontract)), in which case uniQure will transfer the uniQure Manufacturing Know-How to such CMO in accordance with Section 5.4 (Transfer of Manufacturing Know-How), and (b) give uniQure the notice required by Section 14.2 of the Supply Agreement relating to either the termination of the Supply Agreement or the request to have uniQure serve as a second source of Manufacture of the Licensed Products in accordance therewith.
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Transfer of Manufacturing Responsibility. In order to assist Celgene to perform the Celgene Manufacturing Responsibilities, Agios shall (a) transfer, or have transferred, to Celgene or its designee all Manufacturing Technology Controlled by Agios and used in Manufacturing Licensed Products at the time of such transfer to the extent relevant to the Celgene Manufacturing Responsibilities and use Commercially Reasonable Efforts to complete such transfer within [**] after the Effective Date, and (b) provide reasonable assistance in connection with the transfer of such Manufacturing responsibility to Celgene or its designee. The Out-of-Pocket Costs incurred by Agios in connection with such transfer shall be reimbursed by Celgene within [**] after receipt by Celgene of an invoice for such costs.
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Transfer of Manufacturing Responsibility 
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Related to Transfer of Manufacturing Responsibility

  • Transfer of Materials In the event Acceleron exercises its rights pursuant to Section 10.5.1, Celgene shall negotiate in good faith with Acceleron regarding Celgene transferring to Acceleron, at Acceleron’s cost, materials developed under this Agreement in the course of Developing and Commercializing Licensed Compounds or Licensed Products that are directly related to Licensed Compounds or Licensed Products to the extent provided in and in accordance with such agreement.

  • 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.

  • Filing Responsibility PARTICIPANT ACKNOWLEDGES THAT IT IS PARTICIPANT’S SOLE RESPONSIBILITY, AND NOT THE CORPORATION’S, TO FILE A TIMELY ELECTION UNDER CODE SECTION 83(b), EVEN IF PARTICIPANT REQUESTS THE CORPORATION OR ITS REPRESENTATIVES TO MAKE THIS FILING ON HIS OR HER BEHALF.

  • 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.

  • 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.

  • Regulatory Responsibility (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

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

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Supply of Materials Unless the parties otherwise agree in a Work Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Work Order other than the Rhythm Materials specified in such Work Order. Rhythm or its designees will provide Manufacturer with the Rhythm Materials. Manufacturer agrees (a) to account for all Rhythm Materials, (b) not to provide Rhythm Materials to any third party (other than an Affiliate acting as a permitted subcontractor) without the express prior written consent of Rhythm, (c) not to use Rhythm Materials for any purpose other than conducting the Services, including, without limitation, not to analyze, characterize, modify or reverse engineer any Rhythm Materials or take any action to determine the structure or composition of any Rhythm Materials unless required * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. pursuant to a signed Work Order, and (d) to destroy or return to Rhythm all unused quantities of Rhythm Materials according to Rhythm’s written directions.

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