Transition; Manufacturing; Inventory Sample Clauses

Transition; Manufacturing; Inventory. Xxxxxxx agrees, and agrees on behalf of its Affiliates, to reasonably cooperate with Legend and its designee(s) to facilitate a smooth, orderly and prompt transition of the program and activities with respect to Reverted Products, including any ongoing Development, CMC Development, Manufacturing and Commercialization of Reverted Products to Legend or its designee(s), during the Agreement Wind-Down Period, in accordance with this Section 12.4.3 and the applicable provisions of ARTICLE VI; provided, however that Xxxxxxx and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue promotion of any Products after the effective date of termination. If Xxxxxxx or its Affiliate Manufactured any Product, or component thereof or other material used for the Manufacture of Product, at the time of termination, then Xxxxxxx (or its Affiliate) shall continue to provide for manufacturing of such Product, component or other material, for Legend, at the Supply Costs therefor, from the date of notice of such termination until such time as Legend is able, using Diligent Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Product, component or other material, may be procured and legally sold throughout the United States, Greater China and Xxxxxxx Territory, but in any event no longer than [***] after the effective date of termination. If a Manufacturing Subcontractor Manufactures a Product, or component thereof or other material used for the Manufacture of Product, on Xxxxxxx’x or its Affiliate’s behalf at the time of termination, upon request of Legend, Xxxxxxx shall use Diligent Efforts to transfer the applicable Manufacturing Subcontract to Legend on or promptly after the effective date of termination. Prior to expiration of the Agreement Wind-Down Period, (i) Legend shall have the right to purchase from Xxxxxxx, and Xxxxxxx shall sell to Legend if requested by Legend, all of Xxxxxxx’x and its Affiliate’s existing inventory of Reverted Products, or components thereof or other material used for the Manufacture of Reverted Products, at Xxxxxxx’x Supply Cost for such Products, components or other materials (taking into account the portion, if any, of such Supply Costs for such inventory previously shared by Legend under this Agreement) and (ii) Xxxxxxx shall transfer to Legend, or its desi...
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Transition; Manufacturing; Inventory. JBI agrees, and agrees on behalf of its Affiliates, to reasonably cooperate with Pharmacyclics and its designee(s) to facilitate a smooth, orderly and prompt transition of the program and activities with respect to Licensed Compounds and Products, including any ongoing Development, Manufacturing and Commercialization of Licensed Compounds or Products to Pharmacyclics or its designee(s), during the Agreement Wind-Down Period; provided, however that JBI and its Affiliates shall not be obligated to continue any On-Going Clinical Studies (except as necessary to transfer or wind down pursuant to Section 12.4.3(a)) or to continue Commercializing Products after the effective date of termination. If JBI or its Affiliate Manufactured any Licensed Compound or Product at the time of termination, then JBI (or its Affiliate) shall continue to provide for manufacturing of such Licensed Compound or Product for Pharmacyclics, at [**] of the Supply Costs therefor, from the date of notice of such termination until such time as Pharmacyclics is able, using Diligent Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Licensed Compound or Product may be procured and legally sold throughout the United States and License Territory, but in any event no longer than [**] after the effective date of termination. If a Manufacturing Subcontractor Manufactures a Licensed Compound or Product on JBI’s or its Affiliate’s behalf at the time of termination, upon request of Pharmacyclics, JBI shall use Diligent Efforts to transfer the applicable Manufacturing Subcontract to Pharmacyclics on or promptly after the effective date of termination. Prior to expiration of the Agreement Wind-Down Period, Pharmacyclics shall have the right to purchase from JBI, and JBI shall sell to Pharmacyclics if requested by Pharmacyclics, all of JBI’s and its Affiliate’s existing inventory of Licensed Compounds and Products at a price equal to [**] of JBI’s Supply Cost for such Licensed Compounds and Products (taking into account the portion, if any, of such Supply Costs for such inventory previously shared by Pharmacyclics under this Agreement).
Transition; Manufacturing; Inventory. Following the effectiveness of any termination by AVEO pursuant to Section 12.2.1 (Termination for Material Breach), or by AVEO pursuant to Section 12.2.3 (Termination by AVEO) or Section 12.2.4 (Termination for Challenge) or by CANbridge pursuant to Section 12.2.2 (Termination by CANbridge for Convenience), CANbridge and its Affiliates will (a) continue to Manufacture and supply AVEO with its requirements of Product in accordance with ARTICLE 5 (Manufacture and Commercialization) 57 and the Supply Agreement for period requested by AVEO (not to exceed [**] months after the Term; provided, however, that, to the extent AVEO requests a period of more than [**] months, the obligation of CANbridge to Manufacture and supply AVEO with its requirements of Product under this Section 12.3.9 (Transition; Manufacturing; Inventory) for such additional [**] month period will be subject to the Parties agreeing in good faith on a reasonable premium to the transfer price to be paid by AVEO for such Product) and (b) reasonably cooperate with AVEO and its designees to facilitate a smooth, orderly and prompt transition to AVEO or its designees of the activities with respect to Products, including any ongoing Development and Commercialization activities with respect to Products, for a period requested by AVEO (not to exceed [**] months after the Term; provided, however, that, to the extent AVEO requests a period of more than [**] months for such transition activities, the obligation of CANbridge to provide such activities under this Section 12.3.9 (Transition; Manufacturing; Inventory) for such additional [**] month period will be subject to the Parties agreeing in good faith on a reasonable payment to be made by AVEO for such activities). For the period that is [**] days following the effective date of the termination of this Agreement, CANbridge will retain the right to sell, distribute or otherwise dispose of its Product inventory in its or its Affiliates or Sublicensees possession as of the effective date of termination, subject to CANbridge’s continuing obligation to make Sales Milestone Payments and royalty payments in accordance with ARTICLE 6 (Financial Provisions) with respect to Net Sales derived from such distribution, sale and disposition. Without limiting the foregoing, upon the written request of AVEO, CANbridge will promptly, and in any event within [**] days after such request (i) take such steps as may be reasonably necessary to assign to AVEO CANbridge’s righ...

Related to Transition; Manufacturing; Inventory

  • 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 Costs In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, Merck shall be entitled to [*****] (as defined herein) incurred by Merck for its Compound Delivered for the Study. [*****]

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • 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.

  • 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.

  • 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.

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

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

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

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