Common use of Opt-In for Additional Development Activities Clause in Contracts

Opt-In for Additional Development Activities. In the event that the Proposing Party conducts Secondary Indication Study(ies) pursuant to Section 5.2.5.3 (Independent Performance of Additional Development Activities), the Non-Proposing Party may elect, in its discretion and upon written notice to the Proposing Party (an “Additional Development Opt-In Notice”), to opt in with respect to any Secondary Indication Study that was the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 (Independent Performance of Additional Development Activities), and then (i) such Secondary Indication Study shall be deemed to be a Split Territory Global Development Activity under the Split Territory Global Development Plan for the applicable Split Territory Licensed Product from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Party (the “Additional Development Opt-In Date”); (ii) the then-current plan and budget of the Proposing Party with respect to such Secondary Indication Study shall be deemed to be included within, and part of, the Split Territory Global Development Plan for such Split Territory Licensed Product as of the Additional Development Opt-In Date; and (iii) the Non-Proposing Party shall have all rights granted to it under Section 6.2.7 (Right of Reference) with respect to the information and data generated from such Secondary Indication Study as if such Secondary Indication Study was conducted under the Split Territory Global Development Plan for such Split Territory Licensed Product, provided that, the Non-Proposing Party’s right to so opt-in with respect to such Additional Development Activities, triggering the results described in the foregoing clauses (i) through (iii), is conditioned on the [***].

Opt-In for Additional Development Activities. In the event that the Proposing Party conducts Secondary Indication Study(ies) a Supplemental Study or Regional [***] Activity pursuant to Section 5.2.5.3 (Independent Performance of Additional Development Activities5.2.2.4(c), the Proposing Party will provide to the Non-Proposing Party may (i) [***] (the “Additional Development Data Package”). The Non-Proposing Party shall have the one-time right to elect, in its sole discretion and upon written notice to the Proposing Party no later than [***] days after the date the Additional Development Data Package is made available to the Non-Proposing Party (an “Additional Development Opt-In Notice”), to opt in with respect to any Secondary Indication Supplemental Study or Regional [***] Activity that was the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 (Independent Performance of Additional Development Activities5.2.2.4(c), and then (iA) such Secondary Indication Supplemental Study shall or Regional [***] Activity, as applicable, will be deemed to be a Split Territory Global an RLP Development Activity under the Split Territory Global RLP Development Plan for the applicable Split Territory Licensed Product Regional Target from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Party (the “Additional Development Opt-In Date”); (iiB) the then-current plan and budget of the Proposing Party with respect to such Secondary Indication Supplemental Study shall or Regional [***] Activity, as applicable, will be deemed to be included within, and part of, the Split Territory Global RLP Development Plan for such Split Territory Regional Licensed Product as of the Additional Development Opt-In Date, and will control with respect to such Supplemental Study or Regional [***] Activity unless and until an amendment to the RLP Development Plan providing for a different or modified plan and budget is approved by the JDC; and (iiiC) the Non-Proposing Party shall will have all rights granted to it under Section 6.2.7 (Right of Reference) 7.1.3 with respect to the information and data generated from such Secondary Indication Supplemental Study or Regional [***] Activity as if such Secondary Indication Supplemental Study or Regional [***] Activity was conducted under the Split Territory Global RLP Development Plan for such Split Territory Regional Licensed Product, provided that, (1) the Non-Proposing Party’s right to so opt-in with respect to such Additional Development Activities, triggering the results described in the foregoing clauses (iA) through (iiiC), is conditioned on the payment by the Non-Proposing Party to the Proposing Party of a payment of [***] CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. of those costs and expenses incurred by the Proposing Party prior to the Additional Development Opt-in Date that the Non-Proposing Party should have paid in connection with such Additional Development Activities had such Additional Development Activities been included in the RLP Development Plan pursuant to Section 5.2.2.4(b)(i); and (2) any future Development Costs with respect to such Regional Licensed Product, including any future Clinical Studies, will be allocated in accordance with Section 5.2.4.

Opt-In for Additional Development Activities. In the event that the Proposing Party conducts Secondary Indication Study(ies) a Supplemental Study or Regional [***] Activity pursuant to Section 5.2.5.3 (Independent Performance of Additional Development Activities5.2.2.4(c), the Proposing Party will provide to the Non-Proposing Party may (i) [***] (the “Additional Development Data Package”). The Non-Proposing Party shall have the one-time right to elect, in its sole discretion and upon written notice to the Proposing Party no later than [***] days after the date the Additional Development Data Package is made available to the Non-Proposing Party (an “Additional Development Opt-In Notice”), to opt in with respect to any Secondary Indication Supplemental Study or Regional [***] Activity that was the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 (Independent Performance of Additional Development Activities5.2.2.4(c), and then (iA) such Secondary Indication Supplemental Study shall or Regional [***] Activity, as applicable, will be deemed to be a Split Territory Global an RLP Development Activity under the Split Territory Global RLP Development Plan for the applicable Split Territory Licensed Product Regional Target from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Party (the “Additional Development Opt-In Date”); (iiB) the then-current plan and budget of the Proposing Party with respect to such Secondary Indication Supplemental Study shall or Regional [***] Activity, as applicable, will be deemed to be included within, and part of, the Split Territory Global RLP Development Plan for such Split Territory Regional Licensed Product as of the Additional Development Opt-In Date, and will control with respect to such Supplemental Study or Regional [***] Activity unless and until an amendment to the RLP Development Plan providing for a different or modified plan and budget is approved by the JDC; and (iiiC) the Non-Proposing Party shall will have all rights granted to it under Section 6.2.7 (Right of Reference) 7.1.3 with respect to the information and data generated from such Secondary Indication Supplemental Study or Regional [***] Activity as if such Secondary Indication Supplemental Study or Regional [***] Activity was conducted under the Split Territory Global RLP Development Plan for such Split Territory Regional Licensed Product, provided that, (1) the Non-Proposing Party’s right to so opt-in with respect to such Additional Development Activities, triggering the results described in the foregoing clauses (iA) through (iiiC), is conditioned on the payment by the Non-Proposing Party to the Proposing Party of a payment of [***]] of those costs and expenses incurred by the Proposing Party prior to the Additional Development Opt-in Date that the Non-Proposing Party should have paid in connection with such Additional Development Activities had such Additional Development Activities been included in the RLP Development Plan pursuant to Section 5.2.2.4(b)(i); and (2) any future Development Costs with respect to such Regional Licensed Product, including any future Clinical Studies, will be allocated in accordance with Section 5.2.4.

Opt-In for Additional Development Activities. In the event that the Proposing Party conducts Secondary Indication Study(ies) pursuant to Section 5.2.5.3 2.2.2.6(c) (Independent Performance of Additional Development Activities), the Non-Proposing Party may elect, in its discretion and upon written notice to the Proposing Party no later than [***] days after the date on which the [***] (an “Additional Development Opt-In Notice”), to opt in with respect to any Secondary Indication Study that was the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 2.2.2.6(c) (Independent Performance of Additional Development Activities), and then (i) such Secondary Indication Study shall be deemed to be a Split Territory Global Development Activity under the Split Territory Global Development Plan for the applicable Split Territory Regional Licensed Product from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Party (the “Additional Development Opt-In Date”); (ii) the then-current plan and budget of the Proposing Party with respect to such Secondary Indication Study shall be deemed to be included within, and part of, the Split Territory Global Development Plan for such Split Territory Regional Licensed Product as of the Additional Development Opt-In Date; , and (iii) the Non-Proposing Party shall have all rights granted to it under Section 6.2.7 (Right of Reference) with respect to the information and data generated from such Secondary Indication Study as if such Secondary Indication Study was conducted under the Split Territory Global Development Plan for such Split Territory Licensed Product, provided that, the Non-Proposing Party’s right to so opt-in control with respect to such Additional Development Activities, triggering the results described in the foregoing clauses (i) through (iii), is conditioned on the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Opt-In for Additional Development Activities. In the event that the Proposing Party conducts Secondary Indication Study(ies) pursuant to Section 5.2.5.3 (Independent Performance of Non-Additional Development Activities), the Non-Proposing Party may electelects, in its discretion and upon written notice to the Proposing Additional Development Party (an “Additional Development Opt-In Notice”), on a Clinical Study-by-Clinical Study basis, to opt in with respect to any Secondary Indication a given Clinical Study that was within the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 (Independent Performance of Additional Development Activities), and then (i) such Secondary Indication Clinical Study shall be deemed to be a Split Territory Global Development Activity under included in the Split Territory Global Development Plan for the applicable Split Territory Licensed Product GDP from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Non-Additional Development Party (the “Additional Development Opt-In Date”); (ii) the then-current plan and budget of the Proposing Additional Development Party with respect to such Secondary Indication Clinical Study shall be deemed to be included within, within and part of, of the Split Territory Global Development Plan for such Split Territory Licensed Product as of GDP from the Additional Development Opt-In Date, and shall control with respect to such Clinical Study unless and until an amendment to the GDP providing for a different or modified plan and budget is approved by the JSC; and (iii) the NonOut-Proposing Party of-Pocket Costs and FTE Costs associated with such Clinical Study incurred after the Additional Development Opt-In Date shall have all rights granted to it under be treated as Development Costs and shared by the Parties in accordance with Section 6.2.7 4.5; and (Right of Referenceiv) with respect to the information and data generated from such Secondary Indication Study as if such Secondary Indication Study was conducted under the Split Territory Global Development Plan for such Split Territory Licensed Product, provided that, the Non-Proposing Party’s right to so opt-in with respect to such Additional Development Activities, triggering Party shall reimburse the results described in Additional Development Party an amount equal to the foregoing clauses applicable Additional Development Cost Percentage of the costs incurred prior to the Additional Development Opt-In Date by the Additional Development Party and its Affiliates for such Clinical Study (i) through (iiito the extent not previously reimbursed pursuant to subsection 4.2.6(d), is conditioned on ). Such costs will be determined using the [***]same manner of calculating Development Costs under the GDP.

Opt-In for Additional Development Activities. (i) In the event that the Proposing Party conducts Secondary Indication Study(ies) pursuant to Section 5.2.5.3 2.2.2.5(c) (Independent Performance of Additional Development Activities), the Non-Proposing Party may elect, in its discretion and upon written notice to the Proposing Party prior to the date on which [***] (an “Additional Development Opt-In Notice”), to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. CO-CO LICENSE TERMS opt in with respect to any Secondary Indication Study that was the subject of such Additional Development Proposal that the Proposing Party elected to conduct in accordance with Section 5.2.5.3 2.2.2.5(c) (Independent Performance of Additional Development Activities), and then (i) such Secondary Indication Study shall be deemed to be a Split Territory Global Development Activity under the Split Territory Global Development Plan for the applicable Split Territory Co-Co Licensed Product from and after the date on which such Additional Development Opt-In Notice is received by the Proposing Party (the “Additional Development Opt-In Date”); (ii) the then-current plan and budget of the Proposing Party with respect to such Secondary Indication Study shall be deemed to be included within, and part of, the Split Territory Global Development Plan for such Split Territory Co-Co Licensed Product as of the Additional Development Opt-In Date, and shall control with respect to such Secondary Indication Study unless and until an amendment to the Global Development Plan providing for a different or modified plan and budget is approved by the applicable PJSC; and (iii) the Non-Proposing Party shall will have all rights granted to it under Section 6.2.7 3.5 (Right of Reference) with respect to the information and data generated from such Secondary Indication Study as if such Secondary Indication Study was conducted under the Split Territory Global Development Plan for such Split Territory Co-Co Licensed Product, provided that, the Non-Proposing Party’s right to so opt-in with respect to such Additional Development Activities, triggering the results described in the foregoing clauses (i) through (iii), is conditioned on the [***].