Common use of Additional Development Activities Clause in Contracts

Additional Development Activities. If, following the Effective Date, Celgene wishes (i) to conduct a Clinical Trial (including to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints) of Shared Products not contemplated by the Development Plan, (ii) to Develop Shared Products in a country in the Territory for any Indication in the Field other than an Indication for which such Shared Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Shared Products in a country in the Territory other than that being studied in the Development Plan, or (iv) to conduct any other Clinical Trial of a Shared Product in the Field in a country, including any Clinical Trial or study that is not otherwise set forth in the Development Plan, or any Clinical Trial that Celgene believes may have utility to support Regulatory Approval on a global basis (each such study or activity in (i)-(iv) not already included in the then-current Development Plan, an “Additional Study”), then Parties understand and agree that this Section 3.4 shall apply and, accordingly, (A) Celgene shall first provide the proposed trial design and protocol for such Additional Study to the JSC for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the JSC into such Additional Study design and protocol, and (B) following such review by the JSC, Celgene shall provide the final proposed design and projected costs of such Additional Study to the JSC. In any such case the following shall apply: (a) If Vividion, through its members of the JSC, agrees to co-fund such Additional Study or subsequently elects to exercise a Co-Co Buy-In pursuant to Section 3.5, the Parties shall amend the Development Plan and the Development Budget to include such Additional Study, and the Direct Costs of such Additional Study that constitute Worldwide Development Costs shall be included for the purpose of calculating the Development Cost Share in accordance with Section 9.1. (b) If Vividion does not wish to include costs incurred with respect to such proposed Additional Study within the Worldwide Development Costs subject to the Development Cost Share, but Vividion has no material objection to such Additional Study, Celgene may proceed with such Additional Study and would be solely responsible for the conduct and costs of such study, subject to Section 3.4(c) and Section 3.5. (c) For any Additional Study that Vividion does not wish to co-fund, to include in the Worldwide Development Costs subject to the Development Cost Share, or to exercise a Co-Co Buy-In with respect to such Additional Study pursuant to Section 3.5 prior to the initiation of (A) a Pivotal Clinical Trial or (B) a Phase III Study of such Shared Product for the Indication, formulation, dosage form or other attribute of such Shared Product that was the subject of such Additional Study, if the data from such Additional Study thereafter is included as primary efficacy data (and not solely safety data) in the Regulatory Approval in the US Territory for such Indication, formulation, dosage form or other attribute of such Shared Product or informs a reimbursement decision in the US Territory (each, an “Additional Study Approval”), then Vividion shall be deemed to have elected to buy in to such Additional Study (a “Deemed Buy-In”), and shall pay to Celgene for such Additional Study a lump sum payment (“Lump Sum”) equal to [***] percent ([***]%) of the Direct Costs that otherwise would have been apportioned to Vividion as Worldwide Development Costs had Vividion originally opted-in, to conduct such Additional Study prior to the Deemed Buy-In. For example, [***]. Vividion shall pay to Celgene the Deemed Buy-In amounts set forth in this Section 3.4(c) within [***] days after Celgene notifies Vividion in writing that Celgene has received Additional Study Approval in the US Territory. (d) If Vividion elects to co-fund an Additional Study, or elects to exercise a Co-Co Buy-In pursuant to Section 3.5, or is subject to a Deemed Buy-In as set forth in Section 3.4(c), then following Vividion’s decision to co-fund, or following such Co-Co Buy-In, or Deemed Buy-In, as applicable, all data resulting from such Additional Study (including any Shared Product Data) shall be available for use by Vividion (i) in connection with Shared Products in the Field for U.S. Administration, and (ii) in the Territory to perform activities allocated to Vividion in the Development Plan or otherwise as set forth in this Agreement. (e) For clarity, the costs of any such Additional Study shall never be included in the Worldwide Development Cost or be subject to the Development Cost Share pursuant to Section 9.1 (and Vividion shall have no rights to any Shared Product Data arising from any such Additional Study) unless and until (i) Vividion agrees to pay such costs pursuant to Section 3.4(a); (ii) a Co-Co Buy-In occurs pursuant to Section 3.5; or (iii) a Deemed Buy-In occurs pursuant to Section 3.4(c).

Additional Development Activities. If, following the Effective Date, Celgene the Lead Party in the US Territory or the ROW Territory, as applicable (any such Party, the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study (including to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints) of Shared Products not contemplated by the Development Plan, (ii) to Develop Shared Products for a territory in a country in which it is the Territory Lead Party for any Indication in the Field other than an Indication for which such Shared Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Shared Products in for a country in territory for which the Territory Proposing Party is the Lead Party other than that being studied in the Development Plan, or (iv) to conduct any other Clinical Trial of a Shared Product in the Field in for a countryterritory for which the Proposing Party is the Lead Party, including or any Clinical Trial or study that is not otherwise set forth in the Development Plan, or any Clinical Trial that Celgene the Proposing Party believes may have utility to support Regulatory Approval on a global basis in the Proposing Party’s territory, including any Phase IV Study or any combination of pharmaceutical products (each such study or activity in (i)-(iv) not already included in the then-current Development Plan, an “Additional Study”), then Parties understand and agree that this Section 3.4 3.3 shall apply and, accordingly, (A) Celgene the Proposing Party shall first provide the proposed trial design and protocol for such Additional Study to the other Party (the “Non-Proposing Party”), through its members on the JSC for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the Non-Proposing Party’s JSC members into such Additional Study design and protocol, and (B) following such review by the JSCNon-Proposing Party’s JSC members, Celgene the Proposing Party shall provide the final proposed design and projected costs of such Additional Study to the JSCNon-Proposing Party’s JSC members. In any such case the following shall apply: (a) If Vividionthe Non-Proposing Party, through its members of the JSC, agrees to co-fund such Additional Study or subsequently elects to exercise a Co-Co Buy-In pursuant to Section 3.53.4, the Parties shall amend the Development Plan and the Development Budget to include such Additional Study, and and, subject to Section 3.4, the Direct Costs of such Additional Study that constitute Worldwide Development Costs, Manufacturing Costs or other Allowable Expenses shall be included for the purpose purposes of calculating the Development Cost Share in accordance with Section 9.1Profit & Loss Share. (b) If Vividion the Non-Proposing Party does not wish to include costs incurred with respect to such proposed Additional Study within the Worldwide as Development Costs, Manufacturing Costs and other Allowable Expenses subject to the Development Cost Profit & Loss Share, but Vividion the Non-Proposing Party has no material objection to such Additional Study, Celgene the Proposing Party may proceed with such Additional Study and would be solely responsible for the conduct and costs of such study, subject to Section 3.4(c3.3(c) and Section 3.53.4. In such case, the Non-Proposing Party would have no rights to use any resulting data (including any Shared Product Data), except as set forth in Section 3.5(b) with respect to safety information required to be filed with the applicable Regulatory Authorities, in any such filings with Regulatory Authorities in the territory for which such non-funding Party is the Lead Party, unless and until a Co-Co Buy-In occurs as set forth in Section 3.4, or a Deemed Buy-In occurs pursuant to Section 3.3(c). In the event that Celgene is the Non-Proposing Party, Celgene agrees to sell to Vividion sufficient quantities of the Shared Product to conduct the applicable Additional Study at a price equal to Celgene’s cost pursuant to the terms of a supply arrangement to be mutually agreed between the Parties. (c) For any Additional Study that Vividion If (i) the Non-Proposing Party does not wish to co-fundfund an Additional Study, to include in an Additional Study as a Development Cost, Manufacturing Cost or other Allowable Expense (for the Worldwide Development Costs subject to purposes of calculating the Development Cost Profit & Loss Share), or to exercise a Co-Co Buy-In with respect to for such Additional Study pursuant to Section 3.5 3.4 prior to the initiation of (A) a Pivotal Clinical Trial or (B) a Phase III Study of such Shared Product for the Indication, formulation, dosage form or other attribute of such Shared Product that was the subject of such Additional Study, Study and if the data from such Additional Study thereafter is included as primary efficacy data (and not solely safety data) in the Regulatory Approval in the US Territory for such Indication, formulation, dosage form or other attribute of such Shared Product Product, or informs a reimbursement decision decision, in Australia, Austria, Belgium, Brazil, Bulgaria, Croatia, Canada, China, Cyprus, the US Territory Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, New Zealand, Norway, Poland, Portugal, Russia, San Marino, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, the United Kingdom or the United States (each, an “Additional Study Approval”), then Vividion such Non-Proposing Party shall be deemed to have elected to buy in to such Additional Study (a “Deemed Buy-In”), and shall pay to Celgene the Proposing Party for such Additional Study a lump sum payment (“Lump Sum”) equal to [***] percent ([***]%) of the Direct Costs that otherwise would have been apportioned to Vividion the Non-Proposing Party as Worldwide Development Costs, Manufacturing Costs or other Allowable Expenses had Vividion such Non-Proposing Party originally opted-in, to conduct such Additional Study prior to the Deemed Buy-In. For example, [***]. Vividion The Non-Proposing Party shall pay to Celgene the Proposing Party the Deemed Buy-In amounts set forth in this Section 3.4(c3.3(c) within [***] days after Celgene the Proposing Party notifies Vividion the Non-Proposing Party in writing that Celgene the Proposing Party has received Additional Study Approval in the US TerritoryApproval. (d) If Vividion the Non-Proposing Party elects to co-fund an Additional Study, or elects to exercise a Co-Co Buy-In pursuant to Section 3.53.4, or is subject to a Deemed Buy-In as set forth in Section 3.4(c3.3(c), then following Vividionthe Non-Proposing Party’s decision to co-fund, or following such Co-Co Buy-In, or Deemed Buy-In, as applicable, all data resulting from such Additional Study (including any Shared Product Data) shall be available for use by Vividion (i) by the Non-Proposing Party in connection with Shared Products in any territory for which it is the Field for U.S. AdministrationLead Party, and (ii) by both Parties in the Territory to perform activities allocated to Vividion each such Party in the Development Plan or otherwise as set forth in this Agreement. (e) For clarity, the costs of any such Additional Study shall never be included in the Worldwide as Development Cost Costs, Manufacturing Costs or other Allowable Expenses or be subject to the Development Cost Profit & Loss Share pursuant to Section 9.1 (and Vividion the Non-Proposing Party shall have no rights to any Shared Product Data arising from any such Additional Study) unless and until (i) Vividion the Non-Proposing Party agrees to pay such costs pursuant to Section 3.4(a3.3(a); (ii) a Co-Co Buy-In occurs pursuant to Section 3.53.4; or (iii) a Deemed Buy-In occurs pursuant to Section 3.4(c3.3(c).

Additional Development Activities. If, following the Effective Date, Celgene a Party (the “[**]”) wishes (i) to conduct a Clinical Trial or other study (including to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints) of Shared Licensed Products not contemplated by the Development Plan, (ii) to Develop Shared Licensed Products in for a country in territory for which it is the Territory Lead Party for any Indication in the Field other than an Indication for which such Shared Licensed Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Shared Licensed Products in for a country in territory for which the Territory [**] is the Lead Party other than that being studied in the Development Plan, or (iv) to conduct any other Clinical Trial of a Shared Licensed Product in the Field in for a country, including any Clinical Trial or study territory for which the [**] is the Lead Party that is not otherwise set forth in the Development Plan, or any Clinical Trial that Celgene [**] believes may have utility to support Regulatory Approval on a global basis in the [**] territory, including any Phase IV Study or any combination of pharmaceutical products (each such study or activity in (i)-(iv) not already included in the then-current a Development Plan, an “Additional Study[**]”), then Parties understand and agree that this Section 3.4 shall apply and, accordingly, (A) Celgene the [**] shall first provide the proposed trial design and protocol for such Additional Study to the JSC other Party (the “[**]”), through its members of the JDC, for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the JSC [**] Party’s JDC members into such Additional Study design and protocol, and (B) following such review by the JSC[**] Party’s JDC members, Celgene shall provide the final proposed design and projected costs of such Additional Study to the JSC[**] Party’s JSC members. In any such case the following shall apply: (a) If Vividionthe [**], through its members of the JSC, agrees [**] to co-fund [**] such Additional Study or subsequently elects to exercise a Co-Co Buy-In pursuant to Section 3.5Study, the Parties shall amend the Development Plan and the Development Budget to include [**] such Additional Study, and the Direct Costs [**] of such Additional Study that constitute Worldwide Development Costs shall be included for the purpose of calculating [**] in the Development Cost Share share in accordance with Section 9.19.2. (b) If Vividion does not wish [**] to include costs incurred with respect to such proposed Additional Study within the Worldwide Development Costs subject to the Development Cost Shareshare, but Vividion has no material objection to such Additional Study, Celgene the [**] may proceed with such Additional Study and would be solely responsible shall [**] for the conduct and costs [**] of such study. In such case, subject the [**] would have [**] to use any resulting data (including any Licensed Product Data), except as set forth in Section 3.6(b) with respect to safety information required to be filed with the applicable Regulatory Authorities, in any such filings with Regulatory Authorities in the territory for which such [**] is the Lead Party, unless and until a [**] occurs as set forth in Section 3.4, or a [**] occurs pursuant to Section 3.4(c) and Section 3.53.3(c). (c) For any If (i) the [**] an Additional Study, [**] Additional Study that Vividion does not wish to co-fund, to include in the Worldwide as Development Costs subject to the Development Cost Share, or to exercise a Co-Co Buy-In [**] with respect to such Additional Study pursuant to Section 3.5 3.4 prior to the initiation of the earlier of (A) a Pivotal Clinical Trial [**] or (B) a Phase III Study of such Shared Product for [**] and (ii) the Indication, formulation, dosage form or other attribute of such Shared Product that was the subject of such Additional Study, if the data from such Additional Study thereafter is included as primary efficacy data (and not solely safety data) in the Regulatory Approval in the US Territory for such Indication, formulation, dosage form or other attribute of such Shared Product or informs a reimbursement decision in the US Territory [**] (each, an “Additional Study Approval”), then Vividion such [**] shall be deemed to have elected to buy in to such Additional Study (a “Deemed Buy-In[**]”), and shall pay to Celgene the [**] for such Additional Study a lump sum payment (“Lump Sum”) equal to [***] percent ([***]%) of the Direct Costs costs that otherwise would have been apportioned to Vividion the [**] as Worldwide Development Costs had Vividion such [**] originally opted-in, to conduct such Additional Study prior to the Deemed Buy-In[**]. For example, in the case of the Shared 65/35 Program, where Celgene bears sixty-five percent (65%) of the Development Cost share and Agios bears thirty-five percent (35%) of the Development Cost share, if Agios were the [**] and Celgene incurred $[**] in Development Costs prior to the [**], then Agios would be required to pay $[**] (which represents [**] percent ([**]%) of the thirty-five percent (35%) share that Agios otherwise would have been required to pay under the Development Cost share pursuant to Section 9.2). Vividion The [**] shall pay to Celgene the Deemed Buy-In [**] the [**] amounts set forth in this Section 3.4(c3.3(c) within [**] after the [**] days after Celgene notifies Vividion the [**] in writing that Celgene the [**] has received Additional Study Approval in the US TerritoryApproval. (d) If Vividion the Non-Proposing Party elects to co-fund an Additional Study, or elects to exercise a Co-Co Buy-In pursuant to Section 3.53.4, or is subject to a Deemed Buy-In as set forth in Section 3.4(c3.3(c), then following Vividionsuch Non-Proposing Party’s decision to co-fund, or following such Co-Co Buy-In, or Deemed Buy-In, as applicable, all data resulting from such Additional Study (including any Shared Licensed Product Data) shall be available for use by Vividion (i) in connection with Shared Products in the Field for U.S. Administration, Non-Proposing Party [**] and (ii) both Parties in the Territory to perform activities allocated to Vividion each such Party in the Development Plan or otherwise as set forth in this Agreement. (e) For clarity, the costs of any such Additional Study shall never be included in the Worldwide Development Cost or be subject to the Development Cost Share pursuant to Section 9.1 (and Vividion shall have no rights to any Shared Product Data arising from any such Additional Study) unless and until (i) Vividion agrees to pay such costs pursuant to Section 3.4(a); (ii) a Co-Co Buy-In occurs pursuant to Section 3.5; or (iii) a Deemed Buy-In occurs pursuant to Section 3.4(c).