Additional Manufacturing Sample Clauses

Additional Manufacturing. Within […***…] of the Effective Date, Xencor shall request a manufacturing slot from its third party contractor […***…] for the next available […***…] production slot by sending a change order notification. Xencor shall use Commercially Reasonable Efforts to schedule all activities for the foregoing production slot timely with all Manufacturers for completion of manufacturing the respective drug substance and drug product, including fill and finish operations for such production run.
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Additional Manufacturing. At any time after the [ * ] anniversary of the Effective Date, Teva shall have a right, upon written notification to Alexza, to elect to have a Third Party manufacturer that is selected by Teva and reasonably acceptable to Alexza, qualified to manufacture the Product (an “Additional Manufacturer”). Alexza shall thereafter prepare an estimated reasonable budget and implementation plan for approval by Teva to enable such Additional Manufacturer to manufacture the Product. Upon approval by Teva of the implementation plan and budget, Alexza shall enter into an agreement with such Additional Manufacturer to conduct Alexza manufacturing Know-How transfer to enable the Additional Manufacturer to manufacture the Product. All costs and expenses in engaging and qualifying the Additional Manufacturer shall be borne by Teva. The agreement with the Additional Manufacturer shall provide that any time prior to the [ * ] anniversary of the First Commercial Sale, only upon the written notice from Teva (copied to Alexza) of the occurrence of a Failure Event (as defined below in Section 7.5) shall the Additional Manufacturer manufacture Product for Teva. For clarity, Teva shall not initiate or permit any manufacturing by a Third Party or Additional Manufacturer prior to the [ * ] anniversary of the First Commercial Sale, except as provided in Section 7.5. Notwithstanding the foregoing, if Teva desires to serve as the Additional Manufacturer, Alexza and Teva shall discuss in good faith whether Teva should be chosen pursuant to this Section 7.4 as the “Additional Manufacturer” instead of a Third Party manufacturer.
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Additional Manufacturing. At any time after a calendar year in which the number of Units purchased by BLS and its Sublicensees exceeds [ * ] Units or earlier if the Parties agree pursuant to Section 2.3, BLS shall have a right, upon written notification to Alexza, to elect to have a Third Party manufacturer that is selected by Alexza and reasonably acceptable to BLS, qualified to Manufacture the Product (an “Additional Manufacturer”). Alexza shall thereafter prepare an estimated budget and implementation plan for approval by BLS to enable such Third Party to Manufacture the Product. Upon approval of the implementation plan and budget, Alexza shall enter into an agreement with such Third Party Manufacturer to conduct transition activities pursuant to the transition plan and in compliance with Section 10.4(f) to sublicense and otherwise enable the Third Party Manufacturer to Manufacture the Product. All costs and expenses in engaging and qualifying the Third Party Manufacturer in accordance with the implementation plan (including capital equipment costs) shall be borne by [ * ] unless the Parties and/or such Third Party Manufacturer agree otherwise. The agreement with the Third Party Manufacturer shall provide that upon the occurrence of [ * ] the agreement shall be [ * ], [ * ] and [ * ] any and all [ * ] of [ * ] prior to [ * ]. Following completion of the qualification of such Third Party Manufacturer in accordance with the agreed upon implementation plan, [ * ] shall [ * ] the costs and expenses of any annual maintenance for maintaining the capabilities of the Third Party Manufacturer in accordance with the implementation plan until, [ * ], [ * ] starts to use such Third Party Manufacturer to Manufacture the Product, in which case, [ * ] shall [ * ] all costs and expenses of such annual maintenance, unless the Parties and such Third Party Manufacturer agree otherwise. With BLS’ prior approval, which shall not be unreasonably withheld or delayed, but conditioned upon the Parties’ reaching an agreement on how to compensate BLS for its costs and expenses incurred in engaging and qualifying the Third Party Manufacturer, Alexza may use such Third Party Manufacturer to Manufacture and supply a portion or the entire Product ordered by BLS. With BLS’ prior approval, [ * ], and conditioned upon the Parties’ reaching an agreement on how to compensate BLS for its costs and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed sep...
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Additional Manufacturing. If in any Contract Year the forecast ------------------------ volume in number of lots or number of batches of Products increases above the Agreed Manufacturing Level, DMPC shall use all commercially reasonable efforts (taking into consideration DMPC's manufacturing requirements with respect to the Facilities and the manufacturing capacity of the Facilities) to manufacture to satisfy all of EPI's requirements for Products above the Agreed Manufacturing Level. In such case, the parties agree to negotiate in good faith an appropriate increase in the Fixed Costs payable by EPI hereunder. In the event that DMPC and EPI cannot agree to an appropriate increase in Fixed Costs payable for the forecast volume over the Agreed Manufacturing Level, the increase in Fixed Costs shall be determined by an independent, nationally recognized accounting firm, reasonably acceptable to DMPC and EPI, based on the actual increase in fixed manufacturing and overhead costs caused by the forecast volume over the Agreed Manufacturing Level. The expenses of such accounting firm shall be shared equally by DMPC and EPI.
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Related to Additional Manufacturing

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • 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 Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

  • Promotional Materials In the event that the Fund or the Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Adviser will install and maintain, or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.