Common use of Additional Manufacturing Clause in Contracts

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 separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

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 separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. expenses incurred in engaging and qualifying the Third Party Manufacturer, Alexza may access BLS or the Third Party Manufacturer for Manufacture of the Product for use outside of the Field in the Territory or outside of the Territory. Notwithstanding the foregoing, Alexza shall consider in good faith whether BLS should be chosen pursuant to this Section 5.5 as the “Additional Manufacturer” instead of the Third Party Manufacturer.