Common use of Effect of Opt-Out Clause in Contracts

Effect of Opt-Out. For purposes of clarity, and subject to Section 5.13 below, the following provisions will apply with respect to any New Indication Existing Licensed Product from and after the Section 5.12 Opt-out Effective Date: (i) Responsibility and control over the Development of such New Indication Existing Licensed Product shall be entirely in the control of the New Indication Funding Party and the JDC shall have no decision-making authority with respect to such Development, provided that the New Indication Funding Party shall keep the JDC reasonably informed of the plan for Development of the New Indication Existing Licensed Product, the progress of Development activities, and, subject to the other terms of this Section 5.12, the results of such Development efforts; (ii) Neither Party shall have any obligation under Article V hereof with respect to such New Indication Existing Licensed Product except under Sections 5.8 and 5.9; (iii) Any and all clinical data related to such New Indication Existing Licensed Product that is generated by the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 Opt-out Effective Date shall be specifically excluded from the definition of AVEO Collaboration Know-how or AVEO Know-how, in the event AVEO is the New Indication Funding Party, and from the definition of Biogen Idec Collaboration Know-how in the event Biogen Idec is the New Indication Funding Party, subject, in each case, to Section 5.8; (iv) Neither the non-New Indication Funding Party nor any of its Affiliates or Sublicensees shall have the right to access any data related to such New Indication Existing Licensed Product generated solely by or on behalf of the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 Opt-out Effective Date, including to the extent contained in any INDs, BLAs or other submissions related to such New Indication Existing Licensed Product, or to include any such data, in any regulatory filings or submissions in such Party’s Territory or to cross-reference or otherwise make use of or use such data; (v) If the New Indication Funding Party is not, at such time, responsible for Manufacturing the applicable Licensed Product under Article VII, at the request of the New Indication Funding Party, the other Party shall Manufacture and supply, or cause to be Manufactured and supplied, the reasonable requirements of the New Indication Funding Party and its Affiliates and Sublicensees for such New Indication Existing Licensed Product pursuant to, and in accordance with, the provisions of Article VII; (vi) The provisions of Section 8.4 shall not be applicable with respect to such New Indication Existing Licensed Product; and (vii) The provisions of Article VIII (other than Section 8.4) and Article IX shall continue to be applicable with respect to such New Indication Existing Licensed Product.

Effect of Opt-Out. For purposes of clarity, and subject to Section 5.13 below, clarity the following provisions will apply with respect to any New Indication Existing Licensed Product from and after the Section 5.12 5.11 Opt-out Effective Date: (i) Responsibility and control over the Development of such New Indication Existing Licensed Product shall be entirely in the control of the New Indication Funding Party and the JDC shall have no decision-making authority with respect to such Development, provided that the New Indication Funding Party shall keep the JDC reasonably informed of the plan for Development of the New Indication Existing Licensed Product, the progress of Development activities, and, subject to the other terms of this Section 5.125.11, the results of such Development efforts; (ii) Neither Party shall have any obligation under Article V hereof with respect to such New Indication Existing Licensed Product except under Sections 5.8 and 5.9Product; (iii) Any and all clinical data related to such New Indication Existing Licensed Product that is generated by the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 5.11 Opt-out Effective Date shall be specifically excluded from the definition of AVEO Collaboration Know-how or and AVEO Know-how, in the event AVEO is the New Indication Funding Party, and Party or from the definition of Biogen Idec Collaboration Know-how in the event Biogen Idec is the New Indication Funding Party, subject, in each case, to Section 5.8; (iv) Neither the non-New Indication Funding Party nor any of its Affiliates or Sublicensees shall have the right to access any data related to such New Indication Existing Licensed Product generated solely by or on behalf of the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 5.11 Opt-out Effective Date, including to the extent contained in any INDs, BLAs or other submissions related to such New Indication Existing Licensed Product, or to include any such data, in any regulatory filings or submissions in such Party’s Territory or to cross-reference or otherwise make use of or use such data, except for any adverse event data required by Law to be disclosed by the non-Funding Party or any of its Affiliates or Sublicensees; (v) If the New Indication Funding Party is not, not at such time, time responsible for Manufacturing the applicable Licensed Product under Article VII, at the request Funding Party shall be entitled to Manufacture such New Licensed Product for its needs, and shall have the right to deal directly with any Third Party contract manufacturer of the New Indication Funding Party, the other Party shall to arrange for such Third Party contract manufacturer to Manufacture and supply, or cause supply such New Licensed Product to be Manufactured and supplied, the reasonable requirements of the New Indication Funding such Party and its Affiliates and Sublicensees for such New Indication Existing Licensed Product pursuant to, and the purposes contemplated in accordance with, the provisions of Article VIIthis Section 5.11; (vi) The provisions of Section 8.4 shall not be applicable with respect to such New Indication Existing Licensed Product; and (vii) The provisions of Article VIII (other than Section 8.4) and Article IX shall continue to be applicable with respect to such New Indication Existing Licensed Product.

Effect of Opt-Out. For purposes of clarity, and subject If Sage exercises an Opt-Out Right pursuant to Section 5.13 below9.5.1 (Exercise of Opt-Out) for a Product Class, the following provisions will apply with respect to any New Indication Existing Licensed Product then, from and after the Section 5.12 Opt-out Effective Date: (i) Responsibility and control over the Development of such New Indication Existing Licensed Product shall be entirely in the control of the New Indication Funding Party and the JDC shall have no decision-making authority Out Date with respect to the Opt-Out Products: 9.5.2.1 Sage will continue to perform, as the case may be depending on when the Opt-Out Date occurs, (a) the Development activities under the then-applicable Joint Development Plan(s) for such DevelopmentOpt-Out Products, provided that (b) the New Indication Funding Party shall keep Medical Affairs Activities under the JDC reasonably informed of then-applicable Joint Medical Affairs Plan(s) for such Opt-Out Products or (c) the plan Commercialization activities under the then-applicable Joint Commercialization Plan(s) for Development of the New Indication Existing Licensed Productsuch Opt-Out Products, the progress of Development activitiesin each case ((a), and(b) and (c)), subject to the other terms Section 9.5.2.4 (Effect of this Section 5.12Opt-Out), for which Xxxx was responsible thereunder for a single, consecutive transition of period of up to [**] (such period, the results of such Development efforts; (ii) Neither Party shall have any obligation under Article V hereof with respect to such New Indication Existing Licensed Product except under Sections 5.8 and 5.9; (iii) Any and all clinical data related to such New Indication Existing Licensed Product that is generated by the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 “Opt-out Effective Date shall be specifically excluded from Out Wind-Down Period” and such activities, the definition of AVEO Collaboration Know“Opt-how or AVEO KnowOut Wind-how, in the event AVEO is the New Indication Funding PartyDown Activities”, and from Biogen will pay Sage for the definition of Biogen Idec Collaboration KnowJoint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs, as applicable, incurred by Sage to conduct the Opt-how in the event Biogen Idec is the New Indication Funding Party, subjectOut Wind-Down Activities, in each case, to Section 5.8the extent consistent with the corresponding Joint Development Budget, Joint Medical Affairs Budget or Joint Commercialization Budget approved and included in such Joint Development Plan, Joint Medical Affairs Plan or Joint Commercialization Plan prior to the Opt-Out Date or updated versions of one or more of such plans or budgets approved by the JSC to account for the Opt-Out Wind-Down Period for the applicable Product Class (collectively, the “Opt-Out Wind-Down Costs”), and Biogen will pay all undisputed invoiced amounts for such payments to Sage no later than [**] after receiving an applicable invoice from Sage for the same. Notwithstanding the foregoing, if Sage exercises its Opt-Out Right during [**] of any Product Class of Licensed Products, then [**]; (iv) Neither 9.5.2.2 Biogen will become the non-New Indication Funding Regulatory Lead Party nor any of its Affiliates or Sublicensees shall have the right with respect to access any data related to such New Indication Existing Licensed Product generated solely by or on behalf of the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 Opt-out Effective Date, including to the extent contained in any INDs, BLAs or other submissions related to such New Indication Existing Licensed Product, or to include any such data, in any regulatory filings or submissions in such Party’s Territory or to cross-reference or otherwise make use of or use such data; (v) If the New Indication Funding Party is not, at such time, responsible for Manufacturing the applicable Licensed Products in the Profit-Share Territory in the Product under Article VII, at the request of the New Indication Funding Party, the other Party shall Manufacture and supply, or cause to be Manufactured and supplied, the reasonable requirements of the New Indication Funding Party and Class for which Sage exercised its Affiliates and Sublicensees for such New Indication Existing Licensed Product pursuant to, and in accordance with, the provisions of Article VIIOpt-Out Right; (vi) The provisions of Section 8.4 shall not be applicable with respect to such New Indication Existing Licensed Product; and (vii) The provisions of Article VIII (other than Section 8.4) and Article IX shall continue to be applicable with respect to such New Indication Existing Licensed Product.

Effect of Opt-Out. For purposes of clarity, and subject If Sage exercises an Opt-Out Right pursuant to Section 5.13 below9.5.1 (Exercise of Opt-Out) for a Product Class, the following provisions will apply with respect to any New Indication Existing Licensed Product then, from and after the Section 5.12 Opt-out Effective Date: (i) Responsibility and control over the Development of such New Indication Existing Licensed Product shall be entirely in the control of the New Indication Funding Party and the JDC shall have no decision-making authority Out Date with respect to the Opt-Out Products: 9.5.2.1 Sage will continue to perform, as the case may be depending on when the Opt-Out Date occurs, (a) the Development activities under the then-applicable Joint Development Plan(s) for such DevelopmentOpt-Out Products, provided that (b) the New Indication Funding Party shall keep Medical Affairs Activities under the JDC reasonably informed of then-applicable Joint Medical Affairs Plan(s) for such Opt-Out Products or (c) the plan Commercialization activities under the then-applicable Joint Commercialization Plan(s) for Development of the New Indication Existing Licensed Productsuch Opt-Out Products, the progress of Development activitiesin each case ((a), and(b) and (c)), subject to the other terms Section 9.5.2.4 (Effect of this Section 5.12Opt-Out), for which Sage was responsible thereunder for a single, consecutive transition of period of up to [**] (such period, the results of such Development efforts; (ii) Neither Party shall have any obligation under Article V hereof with respect to such New Indication Existing Licensed Product except under Sections 5.8 and 5.9; (iii) Any and all clinical data related to such New Indication Existing Licensed Product that is generated by the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 “Opt-out Effective Date shall be specifically excluded from Out Wind-Down Period” and such activities, the definition of AVEO Collaboration Know“Opt-how or AVEO KnowOut Wind-how, in the event AVEO is the New Indication Funding PartyDown Activities”, and from Biogen will pay Sage for the definition of Biogen Idec Collaboration KnowJoint Development Costs, Joint Medical Affairs Costs and Joint Commercialization Costs, as applicable, incurred by Sage to conduct the Opt-how in the event Biogen Idec is the New Indication Funding Party, subjectOut Wind-Down Activities, in each case, to Section 5.8the extent consistent with the corresponding Joint Development Budget, Joint Medical Affairs Budget or Joint Commercialization Budget approved and included in such Joint Development Plan, Joint Medical Affairs Plan or Joint Commercialization Plan prior to the Opt-Out Date or updated versions of one or more of such plans or budgets approved by the JSC to account for the Opt-Out Wind-Down Period for the applicable Product Class (collectively, the “Opt-Out Wind-Down Costs”), and Biogen will pay all undisputed invoiced amounts for such payments to Sage no later than [**] after receiving an applicable invoice from Sage for the same. Notwithstanding the foregoing, if Sage exercises its Opt-Out Right during [**] of any Product Class of Licensed Products, then [**]; (iv) Neither 9.5.2.2 Biogen will become the non-New Indication Funding Regulatory Lead Party nor any of its Affiliates or Sublicensees shall have the right with respect to access any data related to such New Indication Existing Licensed Product generated solely by or on behalf of the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 Opt-out Effective Date, including to the extent contained in any INDs, BLAs or other submissions related to such New Indication Existing Licensed Product, or to include any such data, in any regulatory filings or submissions in such Party’s Territory or to cross-reference or otherwise make use of or use such data; (v) If the New Indication Funding Party is not, at such time, responsible for Manufacturing the applicable Licensed Products in the Profit-Share Territory in the Product under Article VII, at the request of the New Indication Funding Party, the other Party shall Manufacture and supply, or cause to be Manufactured and supplied, the reasonable requirements of the New Indication Funding Party and Class for which Sage exercised its Affiliates and Sublicensees for such New Indication Existing Licensed Product pursuant to, and in accordance with, the provisions of Article VIIOpt-Out Right; (vi) The provisions 9.5.2.3 Biogen will be solely responsible for all other costs and expenses incurred in connection with the further Development, performance of Section 8.4 shall not be applicable Medical Affairs Activities with respect to such New Indication Existing and Commercialization of the Opt-Out Products in the Profit-Share Territory after the Opt-Out Wind-Down Period, including (a) [**] and (b) [**]; 9.5.2.4 No later than [**] after the Opt-Out Date for a Product Class, Biogen will notify Sage in writing if it desires the Opt-Out Wind Down Period to be less than [**]; 9.5.2.5 Other than the performance of the Opt-Out Wind-Down Activities, Sage will not have any performance obligations or funding obligations with respect to the Opt-Out Products in the Profit-Share Territory under any then-applicable Joint Development Plan(s), Joint Medical Affairs Plan(s) or Joint Commercialization Plan(s), or any other right to the OP&L Share, including under Section 9.3 (Licensed ProductProduct Reconciliation of Shared Costs; Profit Sharing); 9.5.2.6 Biogen will pay Sage the Territory Royalties (a) pursuant to Section 9.8.2 (United States Royalties) for Net Sales of the Opt-Out Products by Biogen and its Related Parties in the United States for their respective Royalty Terms and (b) pursuant to Section 9.8.1 (Biogen Territory Royalties) for Net Sales of the Opt-Out Products by Biogen and its Related Parties in the Biogen Territory (always excluding the United States) for their respective Royalty Terms; 9.5.2.7 the Biogen Territory for the Opt-Out Products will be deemed to include the United States for purposes of this Agreement (except for royalties owed to Sage on Net Sales of the Opt-Out Products in the United States, which will be calculated in accordance with Section 9.8.2 (United States Royalties)); and (vii) The provisions of Article VIII (other than Section 8.4) 9.5.2.8 the Parties will otherwise have the rights and Article IX shall continue to be applicable obligations with respect to such New Indication Existing the Licensed ProductProducts as set forth in this Agreement.

Effect of Opt-Out. For purposes of clarity, and subject In the event SUTRO exercises the SUTRO Opt-Out with respect to Section 5.13 belowa Non-[*] DC (or corresponding Licensed Product) during the Pre-Regulatory Approval Opt-Out Period or Post-Regulatory Approval Opt-Out Period, the following provisions will apply shall apply: (a) with respect to any New Indication Existing Licensed Product from and after the Section 5.12 Opt-out Effective Date: (i) Responsibility and control over the Development of such New Indication Existing Licensed Product shall be entirely in the control of the New Indication Funding Party and the JDC shall have no decision-making authority ongoing Clinical Trials with respect to such DevelopmentNon-[*] DC (or corresponding Licensed Product or Diagnostic Product) conducted by or on behalf of SUTRO for the SUTRO Territory, provided that the New Indication Funding Party shall keep the JDC reasonably informed of the plan for Development of the New Indication Existing Licensed Product, the progress of Development activities, and, subject which CELGENE has not notified SUTRO prior to the other terms of this Section 5.12SUTRO Opt-Out Date that it wishes to assume responsibility, the results of such Development efforts; (ii) Neither Party SUTRO shall have continue to conduct at its expense any obligation under Article V hereof ongoing Clinical Trials with respect to such New Indication Existing Licensed Product except under Sections 5.8 Non-[*] DC only with regard to 39 *Confidential Treatment Requested. those patients enrolled at the date of the SUTRO Opt-Out Date and 5.9; (iii) Any may otherwise cease enrollment and cancel all clinical data related cancelable expenses relating to such New Indication Existing Licensed Product Clinical Trials in accordance with applicable Laws; it being understood and agreed that is generated by the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 following a SUTRO Opt-out Effective Date shall be specifically excluded from the definition of AVEO Collaboration Know-how or AVEO Know-howOut, in the event AVEO is the New Indication Funding Partyof a data lock in such Clinical Trial, upon CELGENE’s request, SUTRO will cooperate with CELGENE as may be reasonably necessary to enable CELGENE to prepare and from the definition of Biogen Idec Collaboration Know-how complete any and all databases, files and reports in the event Biogen Idec is form required for submission to the New Indication Funding Party, subjectRegulatory Authorities; (b) with respect to any ongoing Clinical Trials with respect to such Non-[*] DC (or corresponding Licensed Product or Diagnostic Product) conducted by or on behalf of SUTRO for the SUTRO Territory for which CELGENE has notified SUTRO prior to the SUTRO Opt-Out Date that it wishes to assume responsibility, in each case, to Section 5.8; (iv1) Neither the non-New Indication Funding each Party nor any of its Affiliates or Sublicensees shall have the right to access any data related to such New Indication Existing Licensed Product generated solely by or on behalf of the New Indication Funding Party or any of its Affiliates or Sublicensees from and after the Section 5.12 Opt-out Effective Date, including to the extent contained in any INDs, BLAs or other submissions related to such New Indication Existing Licensed Product, or to include any such data, in any regulatory filings or submissions in such Party’s Territory or to cross-reference or otherwise make use of or use such data; (v) If the New Indication Funding Party is not, at such time, responsible for Manufacturing the applicable Licensed Product under Article VII, at the request of the New Indication Funding Party, cooperate with the other Party shall Manufacture and supply, or cause to be Manufactured and supplied, facilitate the reasonable requirements orderly transfer to CELGENE of the New Indication Funding Party conduct of such Clinical Trials as soon as reasonably practicable after the SUTRO Opt-Out Date, or, in the event CELGENE is not able to obtain all applicable consents and its Affiliates and Sublicensees for approvals under Antitrust Laws, to wind down such New Indication Existing Licensed Product pursuant toClinical Trial, and in accordance with(2) until such time as the conduct of such Clinical Trials has been successfully transferred to CELGENE or completely wound down, the provisions of Article VII; (vi) The provisions of Section 8.4 shall not be applicable with respect to such New Indication Existing Licensed Product; and (vii) The provisions of Article VIII (other than Section 8.4) and Article IX shall SUTRO shall, at its expense, continue to conduct such Clinical Trials or to wind down such Clinical Trial; it being understood and agreed that following an SUTRO Opt-Out, in the event of a data lock in such Clinical Trial, upon CELGENE’s request, SUTRO will cooperate with CELGENE as may be applicable with respect reasonably necessary to such New Indication Existing Licensed Product.enable CELGENE to prepare and complete any and all databases, files and reports in the form required for submission to the Regulatory Authorities;