Common use of Development Milestones Clause in Contracts

Development Milestones. Company shall pay, or cause to be paid, to Licensor the following one-time (except with respect to the last event in the table below), non-refundable, non-creditable milestone payments with respect to the first achievement of the milestone events described in the table below (the “Development Milestones”). Company shall notify Licensor in writing of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Development Milestone Milestone Payment USD Enrollment of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] ​ With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons).

Development Milestones. Company Novo Nordisk shall pay, or cause to be paid, to Licensor provide Zosano with written notice of the following one-time (except actual first occurrence of each development milestone set forth below with respect to each Licensed Product within thirty (30) days after such occurrence. Within thirty (30) days of the last first occurrence of each of the events set forth below with respect to each Licensed Product whether by Xxxxxx, Novo Nordisk, its Affiliates or any of their respective sublicensees, Novo Nordisk shall pay to Zosano the applicable payment set forth below: [**] For purposes of clarity, other than with respect to FDA or EMA approval, which are independent milestones, if for any reason a milestone event set forth above does not occur prior to the occurrence of the subsequent milestone event set forth in the table below)above for a Licensed Product, non-refundable, non-creditable then the skipped milestone event shall be deemed to occur upon the occurrence of the subsequent milestone event. The payments with respect to set forth above in this Section 3.2 shall be payable only once for each such Licensed Product regardless of the first number of indications for which such Licensed Product is developed or approved or the potential repeated achievement of the milestone events described in event by the table below (the “Development Milestones”). Company shall notify Licensor in writing first formulation of the Licensed Product to achieve the above milestones or by further formulations of Licensed Product that do not have a New Dosing Duration relative to the first formulation of the Licensed Product to achieve the above milestones. If Novo Nordisk develops a formulation of Licensed Product with a New Dosing Duration relative to the first formulation of the Licensed Product, then Novo Nordisk shall pay to Zosano an amount equal to each of the above development milestone payments as they occur for such formulation of Licensed Product. However, if development of the first formulation of the Licensed Product to achieve any of the milestones set forth above is discontinued or terminated by CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. Novo Nordisk prior to either FDA approval or EMA approval, and development of a formulation of the Licensed Product with a New Dosing Duration subsequently commences or continues, then [**] of each of the development milestone payments set forth above shall be payable upon the repeated achievement of any such Development Milestone within ten (10) Business Days development milestone event by a formulation of Licensed Product with a New Dosing Duration, and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Development Milestone Milestone Payment USD Enrollment each of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] ​ With respect to each Development Milestone, the corresponding development milestone payments set forth above shall be payable upon the first occurrence of any development milestone event set forth above by a formulation of Licensed Product with a New Dosing Duration. All payments made to Zosano pursuant to this Section 3.2 are non-refundable and may not be made credited against any other payments payable by Novo Nordisk to Zosano under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Agreement.

Development Milestones. Company Novo Nordisk shall pay, or cause to be paid, to Licensor provide Zosano with written notice of the following one-time (except actual first occurrence of each development milestone set forth below with respect to each Licensed Product within thirty (30) days after such occurrence. Within thirty (30) days of the last first occurrence of each of the events set forth below with respect to each Licensed Product whether by Zosano, Novo Nordisk, its Affiliates or any of their respective sublicensees, Novo Nordisk shall pay to Zosano the applicable payment set forth below: [**] For purposes of clarity, other than with respect to FDA or EMA approval, which are independent milestones, if for any reason a milestone event set forth above does not occur prior to the occurrence of the subsequent milestone event set forth in the table below)above for a Licensed Product, non-refundable, non-creditable then the skipped milestone event shall be deemed to occur upon the occurrence of the subsequent milestone event. The payments with respect to set forth above in this Section 3.2 shall be payable only once for each such Licensed Product regardless of the first number of indications for which such Licensed Product is developed or approved or the potential repeated achievement of the milestone events described in event by the table below (the “Development Milestones”). Company shall notify Licensor in writing first formulation of the Licensed Product to achieve the above milestones or by further formulations of Licensed Product that do not have a New Dosing Duration relative to the first formulation of the Licensed Product to achieve the above milestones. If Novo Nordisk develops a formulation of Licensed Product with a New Dosing Duration relative to the first formulation of the Licensed Product, then Novo Nordisk shall pay to Zosano an amount equal to each of the above development milestone payments as they occur for such formulation of Licensed Product. However, if development of the first formulation of the Licensed Product to achieve any of the milestones set forth above is discontinued or terminated by AND EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. Novo Nordisk prior to either FDA approval or EMA approval, and development of a formulation of the Licensed Product with a New Dosing Duration subsequently commences or continues, then [**] of each of the development milestone payments set forth above shall be payable upon the repeated achievement of any such Development Milestone within ten (10) Business Days development milestone event by a formulation of Licensed Product with a New Dosing Duration, and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Development Milestone Milestone Payment USD Enrollment each of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] ​ With respect to each Development Milestone, the corresponding development milestone payments set forth above shall be payable upon the first occurrence of any development milestone event set forth above by a formulation of Licensed Product with a New Dosing Duration. All payments made to Zosano pursuant to this Section 3.2 are non-refundable and may not be made credited against any other payments payable by Novo Nordisk to Zosano under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Agreement.