Transition of Manufacturing and Supply Sample Clauses

Transition of Manufacturing and Supply. Notwithstanding any provision of this MSA to the contrary, upon an early termination by GNE pursuant to Sections 12.3 or 12.5 of the License Agreement, or Section 13.2 of this MSA (for SurModics’ material breach or bankruptcy), SurModics agrees to extend the term of any SOW at GNE’s written request (which shall be at least [*] prior to the date that this MSA with respect to such SOW would terminate or expire) in order to continue Manufacturing and Supply of Product to GNE under such SOW for a reasonable period after the date the MSA as to such SOW would have terminated. If, in connection with a termination of this MSA as to a SOW, the Parties enter into arbitration in accordance with Article 15 of the License Agreement, then the effective date of termination for purposes of this Section shall not be earlier than the final resolution thereof, unless expressly agreed otherwise in writing by the Parties. GNE shall give SurModics at least [*] prior written notice of the date after which Genentech will no longer require SurModics to perform the Manufacturing and Supply of Product under such SOW.
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Transition of Manufacturing and Supply. If the Manufacturing Party for a Collaboration Product elects to exercise its Opt-Out Option pursuant to Section 5.6.4(b), then promptly following the exercise of such Opt-Out Option by the Manufacturing Party, the Parties shall discuss through the JRDC and agree upon a Manufacturing technology transfer plan, subject to Section11.3.2, including a reasonable allocation of costs, for (a) the transfer to the new Manufacturing Party of responsibility for Manufacture of the applicable Collaboration Product for Development and Commercialization, including the transfer of the required Manufacturing process, and transfer and assignment to the new Manufacturing Party of any existing agreement (or portion thereof) relating to the Manufacturing and supply of the Antibody Products pursuant to Section 11.3.2, (b) any technical assistance agreed in such technology transfer plan and assumption of Manufacturing by the new Manufacturing Party or its designee, and (c) [***], any licenses required to be granted to the new Manufacturing Party in connection with such Manufacturing. During the period following the exercise of the applicable Opt-Out Option by the Manufacturing Party, and until Manufacturing for the applicable Collaboration Product is transferred in accordance with the foregoing subclauses (a) through (c), but in no event for longer than a period of [***], the previous Manufacturing Party shall continue to Manufacture and supply (itself or through an Affiliate or Third Party) the applicable Collaboration Product to the new Manufacturing Party, [***].
Sample 1
Transition of Manufacturing and Supply. If 23andMe exercises a Lead Party Option pursuant to Section 5.2(c), or if the Lead Party role is transferred from one Party to the other Party for a given Collaboration Program as a result of a Party exercising an Opt-Out Option or otherwise, then promptly following the exercise of the Lead Party Option or Opt-Out Option, as applicable, the Parties will discuss through the JDC and agree upon a plan, including a reasonable allocation of costs, for (i) the transfer to the new Lead Party of responsibility for manufacture of the applicable Compound or Product for Development and Commercialization, including the transfer of any applicable manufacturing technology, (ii) any technical assistance required in connection with such technology transfer and assumption of manufacturing by the new Lead Party or its designee, and (iii) any licenses required to be granted to the new Lead Party in connection with such manufacturing. During the period following the exercise of the applicable Lead Party Option or Opt Out Option, and until responsibility for manufacture and supply is transferred in accordance with the foregoing clauses (i) through (iii), but in no event for longer than a period of two (2) years (unless otherwise mutually agreed in writing), the previous Lead Party (or GSK in the case of 23andMe’s exercise of the Lead Party Option) shall continue to manufacture and supply (itself or through an Affiliate or Third Party) the applicable Compound or Product to the new Lead Party, at its fully burdened cost of manufacture (or supply if manufactured by a Third Party), plus a xxxx-up consistent with the manufacturing Party’s xxxx-ups for other products, provided that the Parties enter into GSK’s standard manufacturing and supply agreement or a mutually agreed alternative.
Sample 1

Related to Transition of Manufacturing and Supply

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

  • 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.

  • 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.

  • 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.

  • 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.

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

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