Common use of Additional Studies Clause in Contracts

Additional Studies. If a Party (including its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Studies or Development activities for a CoDev Product (beyond the Pivotal Clinical Study or other Clinical Studies included in the then-current CoDev Product Plan), such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any Data or publications supporting any such proposal. In such event, the JDC shall consider such proposal and evaluate the supporting Data and information in good faith. If the Parties both wish to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a CoDev Product Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct such rejected Proposed Study(ies) (such study(ies), in such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1. Notwithstanding the foregoing, the Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product. If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if the Proposing Party disputes the stated likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then such dispute shall be subject to Accelerated Arbitration. The

Additional Studies. If a Party (including its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Studies or Development activities for a CoDev Product (beyond the Pivotal Clinical Study or other Clinical Studies included in the then-current CoDev Product Plan), such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any Data or publications supporting any such proposal. In such event, the JDC shall consider such proposal and evaluate the supporting Data and information in good faith. If the Parties both wish to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a CoDev Product Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct such rejected Proposed Study(ies) (such study(ies), in such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1. Notwithstanding the foregoing, the Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product. If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if the Proposing Party disputes the stated likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then such dispute shall be subject to Accelerated Arbitration. TheProposing Party shall deliver to the JDC regular updates on such Unsponsored Work, and promptly following completion of the Unsponsored Work, a top-line summary of all Data resulting from such Unsponsored Work. For the purposes of this Section 4.4.3.6, “Material Adverse Effect” shall mean any materially adverse impact on the value of a CoDev Product, including but not limited to restriction on a CoDev Product’s label or adverse impact to the safety or efficacy of a CoDev Product.

Additional Studies. If a Party (including through its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Studies Studies, Non-Clinical Development or Development Translational Research activities for a CoDev the Lead Product in the Field which Data could be used in the other Party’s respective Territory (beyond the Pivotal Clinical Study or other Clinical Studies what is then included in the then-current CoDev Product Plan)Joint Development Plan or any Territory Specific Work) in the Field for Development of the Lead Product, such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any supporting Data or publications supporting any such proposal. In such event, the JDC shall consider such proposal and evaluate the supporting Data and information in good faith. . (a) If the Parties both wish to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a CoDev Product the Joint Development Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. . (b) If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting], mutually agree to include the Proposed Study(ies) in a CoDev Product the Joint Development Plan, the Proposing Party may elect to conduct such rejected Proposed Study(ies) (such study(ies), in such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1. Notwithstanding the foregoing, the The Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include the Proposed Study(ies) in a CoDev Product the Joint Development Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Regulatory Approval or Commercialization of a CoDev Productthe Lead Product in the Non-Proposing Party’s respective Territory. If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if Work unless the Proposing Party disputes can establish that such Unsponsored Work is Territory Specific Work, required to achieve Regulatory Approval in [***] or in [***]. If the stated likely potential Material Adverse Effect upon Proposing Party is able to establish that such Unsponsored Work is required for such a Regulatory Approval, then the procurement or maintenance Proposing Party shall be permitted to undertake such Unsponsored Work at its sole expense. The Proposing Party shall deliver to the JSC regular updates on such Unsponsored Work, and promptly Confidential following completion of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then a top-line summary of all Data resulting from such dispute shall be subject to Accelerated Arbitration. TheUnsponsored Work.

Additional Studies. 5.6.1 If a Party (including through its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Development Studies or Development activities for a CoDev Product which Data could be used in the other Party’s Respective Territory (beyond the Pivotal Clinical Study or other Clinical Studies what is then included in an applicable Development Plan or any Territory Specific Studies) in the then-current CoDev Product Plan)Field for Development of the Licensed Product, such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any supporting Data or publications supporting any such proposal. In such event, the JDC JSC shall consider such proposal and evaluate the supporting Data and information in good faith. If If: 5.6.1.1 the Parties both wish to collaborate in the conduct of such Proposed Study(ies)proposed Development, the Proposing Party shall prepare an amendment to a CoDev Product the applicable Development Plan and Joint Development Budget to include the Proposed proposed additional Development Study(ies) and related budget for review and approval by the JDCJSC; or 5.6.1.2 the Non-Proposing Party is not interested in pursuing any such proposed additional Development Study(ies) pursuant to a Development Plan, then, the Non-Proposing Party shall promptly so inform the Proposing Party, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct (i) shall not perform such rejected Proposed Development Study(ies) with respect to the Non-Proposing Party’s Respective Territory and (ii) shall have the right to perform the proposed Development Study(ies) with respect to its Respective Territory (the “Additional Study”) at its own expense. The Proposing Party shall deliver to the JSC regular updates on such study(ies)Additional Study, in and promptly following completion of the Additional Study, a top-line summary of all Data resulting from such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1Additional Study. Notwithstanding the foregoing, the Proposing Party shall not conduct the Additional Study if the Non-Proposing Party may, within [***] days following (a) expresses concerns related to patient safety in the failure of Additional Study and such concerns are supported or can be verified with scientific data or (b) provides commercial or scientific data that the JDC to mutually agreed to include Additional Study will adversely affect the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval Development or Commercialization of a CoDev Licensed Product(s) in the Non-Proposing Party’s Respective Territory or the overall marketing or branding strategy with respect to the Licensed Product. . 5.6.2 If the Non-Proposing Party makes wishes to obtain access to and have the right to use the Data resulting from any Additional Study(ies) in its Regulatory Materials to support any NDA or MAA filings or extension of a Regulatory Approval or any pricing and reimbursement applications, or to otherwise use or disclose such an objectionData, including without limitation for any commercial or medical education purpose (the “Opt-In Right”) in its Respective Territory (other than pursuant to Section 5.6.3 below), it may do so by notice in writing to the Proposing Party shall not be permitted to proceed with such Unsponsored Workat any time, provided that if upon the exercise of its Opt-In Right, the Non-Proposing Party shall reimburse the Proposing Party disputes for ** of its Development Costs for such Additional Study(ies). Following such payment, the stated likely potential Material Adverse Effect upon Data resulting from the procurement Additional Study will be treated for purposes of this Agreement as Data resulting from the Development Plan. 5.6.3 Notwithstanding anything to the contrary in this Agreement, each Party shall have access to and the right to use at no cost to such Party all Data resulting from Additional Studies and Non Development Studies conducted by or maintenance on behalf of Marketing Approval the other Party, its Affiliates and its Sublicensees solely as necessary to comply with safety reporting or Commercialization other similar regulatory requirements in its Respective Territory, and provided that such Party’s license rights and rights of a CoDev Product by the Unsponsored Work, then reference to such dispute Data shall be subject limited solely to Accelerated Arbitration. Thesuch purpose or to other purposes to the extent that such other purposes are necessary to comply with mandatory regulatory requirements. 5.6.4 Notwithstanding anything to the contrary in this Agreement, each Party shall have access to and the right to use at no cost to such Party all Data resulting from Clinical Studies that are Non-Development Studies conducted or funded by or on behalf of the other Party, its Affiliates and its Sublicensees, provided that in each case, such Party’s license rights and rights of reference to such Data shall not include commercially sensitive information regarding Medical Affairs Activities and Commercialization activities in the other Party’s Respective Territory.

Additional Studies. The parties are not obligated to share the costs of conducting any: (a) elective clinical studies such as, by way of example but not limitation clinical studies commonly termed a “Phase IIIB study” or a “Phase IV study” or a study described in clause (ii) of Subsection 4.1.4(a); (b) any study or other activity that a party demonstrates to the other party’s reasonable satisfaction may be necessary to qualify a second source of manufacture in furtherance of the intents of Subsection 4.4.3. and the rights to be granted thereunder; or (c) other studies that the EMA, FDA or any other Regulatory Authority requests as a condition to obtaining regulatory, reimbursement or pricing approval of the Licensed Product (collectively, the “Additional Studies”). If a Party (including its Affiliates or Sublicensees) either party wishes to conduct one an Additional Study described in clause (a) above, or more additional Clinical Studies deems it necessary, in its reasonable opinion, for purposes of optimizing the commercial development and prospects of the Licensed Formulation, or, if an Additional Study described in clause (b) or Development activities for a CoDev Product (beyond c) above is required by the Pivotal Clinical Study EMA the FDA, or other Clinical Studies relevant authorities that grant, directly or indirectly, MA Approvals, pricing and/or reimbursement approval, upon written request by either party, the parties must promptly commence good faith discussions to inform each other regarding the need and purposes of such a study and to develop and agree upon a protocol to govern such a study. If the parties agree to conduct such a study, and neither party may unreasonably withheld its agreement to do so, then the costs of conducting that study will be shared by the parties in the manner and to the extent they may mutually determine. The cost of an Additional Study will not be included in the thendetermination of Total Development Costs. If CPP funds more than a majority of the cost of conducting that study, the data and results from that study will be deemed CPP-current CoDev Product Plan)Owned Data; if TILLOTTS funds a majority of the cost of conducting that study, such Party (the “Proposing Party”) shall notify data and results from the study will be deemed TILLOTTS-Owned Data; if CPP and TILLOTTS equally contribute to funding the cost of conducting that study, then the data and results from that study will be deemed to be jointly owned by CPP and TILLOTTS. If a party initially elects to fund less than half of the cost of conducting that study, that party may elect, without additional cost or charge, any time before the commencement of that study to fund the cost of that study equally with the other Party (party. For the “Non-Proposing Party”) avoidance of such proposed studies (doubt, in order to be able to freely use the “Proposed Study(ies)”) and provide data from the Non-Proposing Party with any Data or publications supporting any such proposal. In such eventinitial majority funding party, the JDC shall consider such proposal and evaluate the supporting Data and information in good faith. If the Parties both wish other party has to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a CoDev Product Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within share [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct such rejected Proposed Study(ies) (such study(ies), in such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1. Notwithstanding the foregoing, the Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include corresponding costs, unless the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product. If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if the Proposing Party disputes the stated likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then such dispute shall be subject to Accelerated Arbitration. Theparties agree otherwise.

Additional Studies. If a Party is interested in conducting an additional Combined Therapy study (including its Affiliates or Sublicenseesin addition to the Initial Trials) wishes to conduct one or more additional Clinical Studies or Development activities for a CoDev Product (beyond the Pivotal Clinical Study or other Clinical Studies included in the then-current CoDev Product Plan), such Party (the “Proposing Party”) ), then the Proposing Party shall notify provide the other Party (the “Non-Proposing Responding Party”) of with a written summary for such proposed studies Combined Therapy study (the “Proposed Study(ies)Additional Study Protocol Summary”) and provide prior to initiating the Non-Proposing Party with any Data or publications supporting any protocol development for such proposalstudy. In such eventWithin [ * ] after receipt of the Additional Study Protocol Summary, the JDC JSC shall consider such proposal meet to review and evaluate discuss the supporting Data and information in good faithAdditional Study Protocol Summary. If the Parties both wish JSC agrees to collaborate in the jointly conduct of a study under this Agreement based on such Proposed Study(ies)Additional Study Protocol Summary, the Proposing Party then such study shall prepare an amendment to be deemed a CoDev Product Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicableCombined Therapy Trial, the Parties do notwill amend this Agreement to add such Combined Therapy Trial to Exhibit A, within [***] days of and the first applicable Parties shall commence Protocol development for such study in accordance with this Agreement. If the JSC meeting, mutually does not agree to include the Proposed Study(ies) in a CoDev Product Planjointly conduct such study under this Agreement, the Proposing Party may elect conduct up to conduct [ * ] such rejected Proposed Study(ies) studies per year independently (such study(ies), in such event, each an “Unsponsored WorkIndependent Combined Therapy Trial”), rather than escalate further as described in Section 3.6.2. 1. Notwithstanding the foregoing, the Non-provided that [ * ] such Proposing Party may, within [***] days following shall conduct such Independent Combined Therapy Trial: (a) in accordance with all Applicable Laws; (b) under the failure oversight of the JDC to mutually agreed to include the Proposed Study(iesJSC; and (c) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work manner that would not have a material adverse effect on the basis Combined Therapy or on the Responding Party’s Compound. For clarity, decisions relating to whether a proposed study will have a material adverse effect on the Responding [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (I) not material and (II) would be competitively harmful if publicly disclosed. 8 Party’s Compound shall be made in the sole reasonable judgment of likely potential Material Adverse Effect upon the procurement Responding Party. Unless otherwise required by a Regulatory Authority, each Independent Combined Therapy Trial shall be conducted under either an existing IND or maintenance of Marketing Approval or Commercialization of a CoDev ProductCombined Therapy IND. If the Non-Proposing Party makes such an objectionFor clarity, the Proposing Party for an Independent Combined Therapy Trial shall be the Conducting Party with respect thereto, and shall have all operational responsibility therefor, but shall not be permitted obliged to proceed provide the Responding Party with any Study Data, other than safety data (and any other data required under the Pharmacovigilance Agreement), or any other information described in Sections 6.2(g), (h), (i), (j), (l), (o), (s), and (u) from such Unsponsored Work, provided that if Independent Combined Therapy Trial unless the Responding Party reimburses the Proposing Party disputes as set forth in Section 8.2. For further clarity, the stated likely potential Material Adverse Effect upon Responding Party shall only have the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product right to use data generated by the Unsponsored WorkProposing Party in an Independent Combined Therapy Trial to the extent reasonably necessary for the Responding Party to comply with its regulatory reporting and compliance obligations, then including safety reporting obligations, and shall have the right to use such dispute data to support its own development, but shall be subject not have the right to Accelerated Arbitrationuse such data for regulatory approval, publications, or commercialization activities except pursuant to Section 8.2. The[ * ]

Additional Studies. 5.6.1 If a Party (including through its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Development Studies or Development activities for a CoDev Product which Data could be used in the other Party’s Respective Territory (beyond the Pivotal Clinical Study or other Clinical Studies what is then included in an applicable Development Plan or any Territory Specific Studies) in the then-current CoDev Product Plan)Field for Development of the Licensed Product, such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any supporting Data or publications supporting any such proposal. In such event, the JDC JSC shall consider such proposal and evaluate the supporting Data and information in good faith. If If: 5.6.1.1 the Parties both wish to collaborate in the conduct of such Proposed Study(ies)proposed Development, the Proposing Party shall prepare an amendment to a CoDev Product the applicable Development Plan and Joint Development Budget to include the Proposed proposed additional Development Study(ies) and related budget for review and approval by the JDCJSC; or 5.6.1.2 the Non-Proposing Party is not interested in pursuing any such proposed additional Development Study(ies) pursuant to a Development Plan, then, the Non-Proposing Party shall promptly so inform the Proposing Party, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct (i) shall not perform such rejected Proposed Development Study(ies) with respect to the European Union and (ii) shall have the right to perform the proposed Development Study(ies) with respect to its Respective ex-EU Territory (the “Additional Study”) at its own expense. The Proposing Party shall deliver to the JSC regular updates on such study(ies)Additional Study, in and promptly following completion of the Additional Study, a top-line summary of all Data resulting from such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2. 1Additional Study. Notwithstanding the foregoing, the Proposing Party shall not conduct the Additional Study if the Non-Proposing Party may, within [***] days following (a) expresses concerns related to patient safety in the failure of Additional Study and such concerns are supported or can be verified with scientific data or (b) provides commercial or scientific data that the JDC to mutually agreed to include Additional Study will adversely affect the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval Development or Commercialization of a CoDev Licensed Product(s) in the Non-Proposing Party’s Respective Territory or the overall marketing or branding strategy with respect to the Licensed Product. . 5.6.2 If the Non-Proposing Party makes wishes to obtain access to and have the right to use the Data resulting from any Additional Study(ies) in its Regulatory Materials to support any NDA or MAA filings or extension of a Regulatory Approval or any pricing and reimbursement applications, or to otherwise use or disclose such an objectionData, including without limitation for any commercial or medical education purpose (the “Opt-In Right”) in its Respective ex-EU Territory (other than pursuant to Section 5.6.3 below), it may do so by notice in writing to the Proposing Party shall not be permitted to proceed with such Unsponsored Workat any time, provided that if upon the exercise of its Opt-In Right, the Non-Proposing Party shall reimburse the Proposing Party disputes for ** of its Development Costs for such Additional Study(ies). Following such payment, the stated likely potential Material Adverse Effect upon Data resulting from the procurement Additional Study will be treated for purposes of this Agreement as Data resulting from the Development Plan. 5.6.3 Notwithstanding anything to the contrary in this Agreement, each Party shall have access to and the right to use at no cost to such Party all Data resulting from Additional Studies and Non Development Studies conducted by or maintenance on behalf of Marketing Approval the other Party, its Affiliates and its Sublicensees solely as necessary to comply with safety reporting or Commercialization other similar regulatory requirements in its Respective Territory, and provided that such Party’s license rights and rights of a CoDev Product by the Unsponsored Work, then reference to such dispute Data shall be subject limited solely to Accelerated Arbitration. Thesuch purpose or to other purposes to the extent that such other purposes are necessary to comply with mandatory regulatory requirements. 5.6.4 Notwithstanding anything to the contrary in this Agreement, each Party shall have access to and the right to use at no cost to such Party all Data resulting from Clinical Studies that are Non-Development Studies conducted or funded by or on behalf of the other Party, its Affiliates and its Sublicensees, provided that in each case, such Party’s license rights and rights of reference to such Data shall not include commercially sensitive information regarding Medical Affairs Activities and Commercialization activities in the other Party’s Respective EU Territories.