Common use of Lead Product Clause in Contracts

Lead Product. 4.4.1.1. As of April 15, 2017, AstraZeneca will assume responsibility for all costs (including Pieris’ Out-of-Pocket Costs and FTE Costs) for the further Research, Development, and Manufacture (to the extent applicable), of the Lead Product as set forth in the initial Lead Product Development Plan, up to the amount of a mutually agreed budget which is set forth in the initial Lead Product Development Plan plus an overrun margin of [***] percent ([***]%) of the mutually-agreed budget, up to Completion of the Phase 1 Study for the Lead Product. Pieris shall notify AstraZeneca as soon as reasonably possible if Pieris becomes aware that the agreed budget is going to be exceeded. For avoidance of doubt, such costs shall be reimbursed by AstraZeneca as incurred by Pieris in accordance with its Accounting Standards. In case Pieris expects a cost overrun of more than [***] percent ([***]%) of the mutually agreed budget, Pieris shall inform AstraZeneca in writing before such cost above [***] percent ([***]%) overrun are incurred. AstraZeneca shall inform Pieris promptly whether it agrees to pay for such cost overrun above [***] percent ([***]%). For clarity, if AstraZeneca does not agree to pay for such cost overrun above [***] percent ([***]%), Pieris shall not be obligated to conduct the activities that would lead to such additional cost overrun above [***] percent ([***]%). In case AstraZeneca requests additional activities to be conducted by Pieris or a Third Party during such time, it shall also assume responsibility for all costs incurred in conducting such additional activities. Such Out-of-Pocket Costs and FTE Costs shall be reimbursed each Calendar Quarter within [***] ([***]) days of receipt by AstraZeneca of an invoice for such costs. AstraZeneca may request supporting documentation evidencing that such costs have been incurred and Pieris shall provide such information if requested. Should there be a dispute as to whether such costs have been incurred, the matter shall be addressed under the dispute resolution provisions in Section 15.1. In case any amount that has been paid by AstraZeneca is disputed and later shown not to have been incurred in accordance with this Agreement, AstraZeneca may credit such unjustified and paid amount against any future payments to Pieris under this Agreement. In the period between the Completion of the Phase 1 Study for the Lead Product and Pieris’ determination of whether it will exercise its Lead Product CoDev Option in accordance with Section 4.5.1 below AstraZeneca shall have sole responsibility for all costs for the further Research, Development, Manufacture (to the extent applicable) of the Lead Product (including Pieris’ Out-of-Pocket Costs and FTE Costs, to the extent that Pieris is assigned any activities under the then-current Lead Product Development Plan). 4.4.1.2. Concurrent with execution of the Lead Product CoDev Option, Pieris shall select whether it wishes to [***] split the Development Costs associated with the continued Development and Manufacture of the Lead Product (the “[***]”) or whether it wishes to contribute [***] of the Development Costs associated with the continued Development and Manufacture of the Lead Product (the “[***] Split Option”). Should the total budget for the updated Lead Product Development Plan as set forth in Section 4.1.2.2 exceed [***] dollars ($[***]), then Pieris may, in the alternative, elect to contribute [***] of the Development Costs associated with the continued Development and Manufacture of the Lead Product up to a cap of [***] dollars ($[***]) (the “[***] Cap Option”). 4.4.1.3. AstraZeneca shall at all times be responsible for all costs associated with Commercialization of the Lead Product. In the event that Pieris exercises it Co-Commercialization Option under Section 7.1, AstraZeneca shall be responsible for [***] co-Commercializing the Lead Product as set forth in Section 7.2. 4.4.1.4. If Pieris exercises the Opt-Out Option with respect to the Lead Product under Section 4.6, then Pieris shall no longer be responsible for contributing to the Development Costs for such Product incurred after the end of the Opt-Out Option Notice period under Section 4.7.2.

Lead Product. 4.4.1.1. As of April 15, 2017, AstraZeneca will assume responsibility for all costs (including Pieris’ Out-of-Pocket Costs and FTE Costs) for the further Research, Development, and Manufacture (to the extent applicable), of the Lead Product as set forth in the initial Lead Product Development Plan, up to the amount of a mutually agreed budget which is set forth in the initial Lead Product Development Plan plus an overrun margin of [***] percent ([***]%) of the mutually-agreed budget, up to Completion of the Phase 1 Study for the Lead Product. Pieris shall notify AstraZeneca as soon as reasonably possible if Pieris becomes aware that the agreed budget is going to be exceeded. For avoidance of doubt, such costs shall be reimbursed by AstraZeneca as incurred by Pieris in accordance with its Accounting Standards. In case Pieris expects a cost overrun of more than [***] percent ([***]%) of the mutually agreed budget, Pieris shall inform AstraZeneca in writing before such cost above [***] percent ([***]%) overrun are incurred. AstraZeneca shall inform Pieris promptly whether it agrees to pay for such cost overrun above [***] percent ([***]%). For clarity, if AstraZeneca does not agree to pay for such cost overrun above [***] percent ([***]%), Pieris shall not be obligated to conduct the activities that would lead to such additional cost overrun above [***] percent ([***]%). In case AstraZeneca requests additional activities to be conducted by Pieris or a Third Party during such time, it shall also assume responsibility for all costs incurred in conducting such additional activities. Such Out-of-Pocket Costs and FTE Costs shall be reimbursed each Calendar Quarter within [***] ([***]) days of receipt by AstraZeneca of an invoice for such costs. AstraZeneca may request supporting documentation evidencing that such costs have been incurred and Pieris shall provide such information if requested. Should there be a dispute as to whether such costs have been incurred, the matter shall be addressed under the dispute resolution provisions in Section 15.1. In case any amount that has been paid by AstraZeneca is disputed and later shown not to have been incurred in accordance with this Agreement, AstraZeneca may credit such unjustified and paid amount against any future payments to Pieris under this Agreement. In the period between the Completion of the Phase 1 Study for the Lead Product and Pieris’ determination of whether it will exercise its Lead Product CoDev Option in accordance with Section 4.5.1 below AstraZeneca shall have sole responsibility for all costs for the further Research, Development, Manufacture (to the extent applicable) of the Lead Product (including Pieris’ Out-of-Pocket Costs and FTE Costs, to the extent that Pieris is assigned any activities under the then-current Lead Product Development Plan). 4.4.1.2. Concurrent with execution of the Lead Product CoDev Option, Pieris shall select whether it wishes to [***] split the Development Costs associated with the continued Development and Manufacture of the Lead Product (the “[***]”) or whether it wishes to contribute [***] of the Development Costs associated with the continued Development and Manufacture of the Lead Product (the “[***] Split Option”). Should the total budget for the updated Lead Product Development Plan as set forth in Section 4.1.2.2 exceed [***] dollars ($[***]), then Pieris may, in the alternative, elect to contribute [***] of the Development Costs associated with the continued Development and Manufacture of the Lead Product up to a cap of [***] dollars ($[***]) (the “[***] Cap Option”). 4.4.1.3. AstraZeneca shall at all times be responsible for all costs associated with Commercialization of the Lead Product. In the event that Pieris exercises it Co-Commercialization Option under Section 7.1, AstraZeneca shall be responsible for [***] co-Commercializing the Lead Product as set forth in Section 7.2. 4.4.1.4. If Pieris exercises the Opt-Out Option with respect to the Lead Product under Section 4.6, then Pieris shall no longer be responsible for contributing to the Development Costs for such Product incurred after the end of the Opt-Out Option Notice period under Section 4.7.2.