Additional Manufacturing Sample Clauses

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.

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...

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.