Common use of Collaboration Products Clause in Contracts

Collaboration Products. The financial terms for any Product that is a Collaboration Product (including royalty rates and sales milestone payments) and the diligence obligations for any such Product (including Commercial Launch obligations and Minimum Revenue Requirements) must be mutually agreed to in writing by the Parties, taking into consideration the relative contributions made by each Party to the development of such Product, before such Product is included in this Agreement. Following FMI’s decision to Commercially Launch a Collaboration Product in the Territory, FMI shall provide written notice to Roche, and if the Parties cannot agree to terms and conditions for the inclusion of such Collaboration Product as a Product in this Agreement within […***…] (the “Initial Discussion Period”), then the Parties shall each select an independent Third Party expert who is neutral, disinterested and impartial, and has significant relevant experience in the development and commercialization of pharmaceutical products (the “Expert”). Each Expert will within […***…] select a […***…] Expert to form a panel of […***…] Experts (“Panel”). The date on which such Panel is in place will be the “Arbitration Commencement Date.” Each Party shall within […***…] following the Arbitration Commencement Date prepare and deliver to both the Panel and the other Party its proposed financial terms (including royalty rates and sales ***Confidential Treatment Requested*** milestone payments) and diligence obligations (including initial launch and minimum revenue requirements) (collectively, the “Arbitration Offer”) to resolve the disputed matter for such Product and a memorandum (the “Supporting Memorandum”) in support thereof; provided that such Arbitration Offer shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the Initial Discussion Period. The Panel will also be provided with a copy of this Agreement. Within […***…] after receipt of the other Party’s Supporting Memorandum, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Party’s Supporting Memorandum (a “Rebuttal”), which may include a revision, marked to show changes, of either Party’s proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this Section 8.3.5. Within […***…] after the Panel’s receipt of each Party’s Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche (the “Selected Agreement”). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Agreement shall become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Experts’ fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred in connection with any proceedings under this Section 8.3.5.

Collaboration Products. The financial terms for any Product each Product, […***…] that is a Collaboration Product (including royalty rates and sales milestone payments) ), and the diligence obligations for any such Product (including Commercial Launch obligations and Minimum Revenue Requirements) must be mutually agreed to in writing by the Parties, taking into consideration the relative contributions made by each Party to the development of such Product, before such Product is included in this Agreement. Following FMI’s decision to Commercially Launch a Collaboration Product (other than FACT or F1CDx) in any country in the Territory, FMI shall provide written notice to Roche, and if the Parties cannot agree to terms and conditions for the inclusion of such Collaboration Product as a Product in this Agreement within […***…] (the “Initial Discussion Period”), then the Parties shall each select an independent Third Party expert who is neutral, disinterested and impartial, and has significant relevant experience in the development and commercialization of pharmaceutical products (the “Expert”). Each Expert will within […***…] select a […***…] Expert - 34 - ***Confidential Treatment Requested*** to form a panel of […***…] Experts (“Panel”). The date on which such Panel is in place will be the “Arbitration Commencement Date.” Each Party shall shall, within […***…] following the Arbitration Commencement Date Date, prepare and deliver to both the Panel and the other Party its proposed financial terms (including royalty rates and sales ***Confidential Treatment Requested*** milestone payments) and diligence obligations (including initial launch and minimum revenue requirements) (collectively, the “Arbitration Offer”) to resolve the disputed matter for such Product and a memorandum (the “Supporting Memorandum”) in support thereof; provided that such Arbitration Offer shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the Initial Discussion Period. The Panel will also be provided with a copy of this Agreement. Within […***…] after receipt of the other Party’s Supporting Memorandum, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Party’s Supporting Memorandum (a “Rebuttal”), which may include a revision, marked to show changes, of either Party’s proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this Section 8.3.5. Within […***…] after the Panel’s receipt of each Party’s Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche (the “Selected Agreement”). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Agreement shall become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Experts’ fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred in connection with any proceedings under this Section 8.3.5.

Collaboration Products. Beam shall keep Prime informed as to material developments related to interactions by it, its Affiliates or sublicensees with Regulatory Authorities with respect to all Collaboration Products. The financial terms regulatory strategy for any Product that is a Collaboration Product (including royalty rates and sales milestone payments) and the diligence obligations for any such Product (including Commercial Launch obligations and Minimum Revenue Requirements) must be mutually agreed to in writing by the Parties, taking into consideration the relative contributions made by each Party to the development of such Product, before such Product is included in this Agreement. Following FMI’s decision to Commercially Launch a Collaboration Product in the TerritoryBeam Field shall be formulated by the JSC. In the event that Beam exercises its final decision-making authority to determine the regulatory strategy for a Collaboration Product at the JSC under this Agreement, FMI Beam shall provide written notice consider in good faith Prime’s reasonable comments to Roche, and if the Parties cannot agree to terms and conditions such regulatory strategy for the inclusion of such Collaboration Product in the Collaboration Territory. With respect to any material communication with a Regulatory 52 Authority in a Major Market related to any Collaboration Product, Beam shall allow Prime a reasonable opportunity to review and comment on Xxxx’s proposed response to such material communication in advance of the transmission of such response, and Beam shall reasonably consider all comments timely provided by Prime in connection therewith. Beam shall provide Prime with reasonable advance notice of all meetings with the Governmental Authorities in the Territory pertaining to each Collaboration Product, or with as a Product in this Agreement within much advance notice as practicable under the circumstances and Prime may have […***…] ]. Beam shall be responsible for leading all interactions with Regulatory Authorities (the “Initial Discussion Period”)e.g., then the Parties shall each select an independent Third Party expert who is neutralmeetings, disinterested and impartialtelephone calls, and has significant relevant experience etc.) in the development and commercialization of pharmaceutical products (Territory relating to Collaboration Products in the “Expert”)Beam Field. Each Expert will within […***…] select a […***…] Expert As between the Parties, Xxxx shall be responsible for preparing all submissions, documents or other correspondence submitted to form a panel of […***…] Experts (“Panel”). The date on which such Panel is applicable Regulatory Authorities for Collaboration Products in place will be the “Arbitration Commencement Date.” Each Party shall within […***…] following Beam Field in the Arbitration Commencement Date prepare and deliver to both the Panel and the other Party its proposed financial terms (including royalty rates and sales ***Confidential Treatment Requested*** milestone payments) and diligence obligations (including initial launch and minimum revenue requirements) Territory (collectively, the “Arbitration OfferCollaboration Product Regulatory Documentation”), and Beam or its designee(s) shall own all Collaboration Product Regulatory Documentation, INDs, NDAs and Marketing Authorizations with respect to resolve all Collaboration Products in the disputed matter Beam Field. Beam or its designee(s) shall also be responsible for all maintenance of all INDs and all NDAs related to Collaboration Products in the Beam Field. Beam shall provide Prime with written notice of each of the following events with regard to each Collaboration Product within a reasonable period of time following the occurrence thereof (but in any event no later than [***] thereafter), to the extent notice was not previously provided: (a) the submission of any filings or applications for Marketing Authorization (other than INDs) of such Collaboration Products in each Major Market to any Regulatory Authority; and (b) receipt or denial of Marketing Authorization for any such filings or applications for such Product and a memorandum (the “Supporting Memorandum”) Collaboration Products in support thereofeach Major Market; provided provided, however, that Beam shall inform Prime of such Arbitration Offer event prior to public disclosure of such event by Beam. In addition, Xxxx shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the Initial Discussion Period. The Panel will also be provided provide Prime with a copy of this Agreement. Within […***…] after receipt all proposed material regulatory filings for any Collaboration Product for Prime’s review and comment sufficiently in advance of the other PartyXxxx’s Supporting Memorandumfiling or submission thereof, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Party’s Supporting Memorandum (a “Rebuttal”), which may include a revision, marked to show changes, of either Party’s proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this Section 8.3.5. Within […***…] after the Panel’s receipt of each Party’s Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals and Beam shall reasonably consider all comments timely provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche (the “Selected Agreement”). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Agreement shall become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Experts’ fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred Prime in connection with any proceedings under this Section 8.3.5therewith.