Common use of Right of Reference Clause in Contracts

Right of Reference. Except with respect to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) each Party will grant, and hereby does grant, to the other Party a right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party or its Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the Territory. Partner may use such right of reference to Kiniksa’s Regulatory Submissions solely to seek, obtain, support, and maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory. Kiniksa may use such right of reference to Partner’s Regulatory Submissions, if any, solely to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Product outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product outside of the Territory (if Kiniksa is the Party seeking Regulatory Approval).

Right of Reference. Except with respect to the New Development of the any Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses [***] as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) Costs), each Party will grant, and hereby does grant, to the other Party a right of reference to all Regulatory Submissions pertaining to the Licensed Product Products in the Field submitted by or on behalf of such Party or its Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa ImmunoGen is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa ImmunoGen outside of the Territory. Partner may use such right of reference to KiniksaImmunoGen’s Regulatory Submissions solely for the purpose of performing Development activities for the Licensed Products in accordance with this Agreement and the Global Development Plan or Territory Development Plan and to seek, obtain, support, and maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product Products in the Field in the Territory. Kiniksa ImmunoGen may use such right of reference to Partner’s Regulatory Submissions, if any, solely for the purpose of Developing the Licensed Products and to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Product Products outside of the Territory. Each Party will bear its own costs and expenses [***] associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include (i) providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product Products outside of the Territory (if Kiniksa ImmunoGen is the Party seeking Regulatory Approval), or (ii) providing the other Party with any underlying raw data or information submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Submissions Controlled by such granting Party or its Affiliates that relates to any Licensed Product.

Right of Reference. Except with respect to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) each Party will grant, and hereby does grant, to the other Party a right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party or its Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the Territory. Partner may use such right of reference to Kiniksa’s Regulatory Submissions solely to seek, obtain, support, and maintain ​ ​ Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory. Kiniksa may use such right of reference to Partner’s Regulatory Submissions, if any, solely to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Product outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product outside of the Territory (if Kiniksa is the Party seeking Regulatory Approval).

Right of Reference. Except with respect to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) each Each Party will grant, and hereby does grant, to the other Party a right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field in the Territory submitted by or on behalf of such Party or its Affiliates, which right Affiliates (in case of reference BioCryst) or Controlled Affiliates (a) to Regulatory Submissions submitted by or on behalf in case of Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the TerritoryTorii). Partner Torii may use such right of reference to KiniksaBioCryst’s Regulatory Submissions solely to seekfor the purpose of seeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the TerritoryTerritory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer Date. Kiniksa BioCryst may use such right of reference to PartnerTorii’s Regulatory SubmissionsSubmissions solely for the purpose of seeking, if anyobtaining, solely to seek, obtain, supportsupporting, and maintain maintaining Regulatory Approval and any Reimbursement Approvals for of the Licensed Product outside of the TerritoryTerritory or in the Territory outside of the Field. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 3.5 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 3.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include (a) providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities or other Governmental Authorities related to such Party’s application XXXx or applications for Regulatory Reimbursement Approval of for the Licensed Product in the Field in the Territory (if Partner Torii is the Party seeking Regulatory Approval or Reimbursement Approval) and of the Licensed Product outside of the Territory or in the Territory outside of the Field (if Kiniksa BioCryst is the Party seeking Regulatory Approval or Reimbursement Approval), or (b) providing the other Party with any underlying raw data or information submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Submissions Controlled by such granting Party or its Controlled Affiliates that relates to the Licensed Product in the Field in the Territory. Notwithstanding any provision to the contrary set forth in this Agreement, BioCryst will only allow its other licensees the rights to cross-reference Torii’s regulatory filings granted under this Section 3.5 (Right of Reference) if such licensees have agreed to permit BioCryst to allow Torii the right to cross-reference such other licensees’ regulatory filings (including clinical data) for no monetary or in-kind consideration (unless BioCryst bears responsibility for any additional monetary or in-kind consideration due to such licensee in consideration for such rights to cross-reference).

Right of Reference. Except with respect Subject to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) 5.8, each Party will grant, and hereby does grant, grants to the other Party a the right of reference to all Regulatory Submissions Documents pertaining to the Licensed Product Products in the Field submitted by or on behalf of such Party or its Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the TerritoryParty. Partner Licensee may use such right of reference to KiniksaReViral’s Regulatory Submissions Documents in the Field solely to seekfor the purpose of seeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approvals Approval and any Reimbursement Approvals, as applicable, for Pricing Approval of the Licensed Product License Products in the Field in the Territory. Kiniksa ReViral may use such right of reference to PartnerLicensee’s Regulatory SubmissionsDocuments in the Field solely for the purpose of seeking, if anyobtaining, solely to seek, obtain, supportsupporting, and maintain maintaining Regulatory Approval and any Reimbursement Approvals for Pricing Approval of the Licensed Product Products outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference)6.6. Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 (Right of Reference) 6.6 and to give the other Party the benefit of the granting Party’s Regulatory Submissions Documents in the other Party’s territory as provided herein. Such actions may include (i) providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product in the Territory (if Partner Licensee is the Party seeking Regulatory Approval) and of the Licensed Product outside of the Territory (if Kiniksa ReViral is the Party seeking Regulatory Approval), or (ii) providing the other Party with any underlying raw data or information submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Documents Controlled by such granting Party or its Affiliates that relates to any Licensed Product.

Right of Reference. Except with respect Subject to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) 6.2, each Party will grant, and hereby does grant, grants to the other Party and its Sublicensees, without any charge or fee, a right of reference to all Data included in the Regulatory Submissions pertaining Filings and marketing authorizations Controlled by such Party and to all Data Controlled by such Party included in Regulatory Filings and marketing authorizations Controlled by such other Party, relating to Licensed Compounds and Products to the extent necessary or useful for such other Party (a) in the case of MTPC, to Develop, conduct Manufacturing (solely as permitted under Section 2.1 and Section 2.2), and Commercialize the Licensed Product Compound and Products in the Field submitted by or on behalf of such Party or its Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in the MTPC Territory, and (b) in the case of ADCT, to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the Territory. Partner may use such right of reference to Kiniksa’s Regulatory Submissions solely to seekDevelop, obtain, supportManufacture, and maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for Commercialize the Licensed Product Compound and Products in any field in any country in the Field in the Territory. Kiniksa may use such right of reference to Partner’s Regulatory Submissions, if any, solely to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Product outside of the ADCT Territory. Each Party will bear its own costs and expenses associated with providing shall provide a signed statement to the other Party with that such other Party may rely on, in support of the right approval of reference pursuant such other Party’s Regulatory Filings, and provide the applicable Regulatory Authority access to this Section 6.5 (Right of Reference)a) the underlying raw data included in such Regulatory Filings and marketing authorizations Controlled by such Party and (b) the underlying raw data Controlled by such Party included in such Regulatory Filings and marketing authorizations Controlled by such other Party. Each Party will take shall maintain, at its expense, during the Term, all data, and the underlying raw data thereof, Controlled by such actions as may Party included or to be reasonably requested included in Regulatory Filings and marketing authorizations Controlled by the other Party to give effect the extent necessary or useful for such other Party to maintain and/or file the intent of this Section 6.5 (Right of Reference) Regulatory Filings for and to give maintain marketing authorizations of Licensed Compounds and Products. Each Party shall store the relevant Data and information Controlled by such Party to be used for applying, obtaining and maintaining Regulatory Approval for the Products in accordance with such Party’s standard operating procedures or as reasonably requested in writing by the other Party the benefit for purposes of the granting Party’s Regulatory Submissions in the other Party’s territory as provided hereincompliance with Applicable Law in the Territory. Such actions may include providing to In the event there are concerns about the quality of any Data, and the underlying raw data thereof, Controlled by such Party, the Parties agree that the other Party copies of correspondence and communications received from has the applicable Regulatory Authorities related right to such Party’s application for Regulatory Approval of conduct reasonable quality assurance audits with respect to the Licensed Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product outside of the Territory (if Kiniksa is the Party seeking Regulatory Approval)said Data to verify conformance with Applicable Laws.

Right of Reference. Except with respect to the New Development of the Licensed Product for a Global Clinical Trial for which Partner does not agree to bear its share of costs and expenses as set forth under Section 5.5.3 (Partner Sharing of Development Costs and Data Access) each Each Party will grant, and hereby does grant, to the other Party and its Affiliates, licensees, and Sublicensees a right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party or its Affiliates. Licensee will grant, which and hereby does grant, to Akebia and its Affiliates, licensees (including [**]), and Sublicensees a right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner all Licensee Development Data developed in the Territory, Licensee’s activities under this Agreement. Licensee and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to Kiniksa outside of the Territory. Partner its Affiliates and Sublicensees may use such right of reference to KiniksaAkebia’s Regulatory Submissions solely to seekfor the purpose of seeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory. Kiniksa Akebia and its Affiliates, licensees, and Sublicensees may use such right of reference to PartnerLicensee’s Regulatory SubmissionsSubmissions solely for the purpose of seeking, if anyobtaining, solely to seek, obtain, supportsupporting, and maintain maintaining Regulatory Approval and any Reimbursement Approvals for of the Licensed Product outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.5 4.2.4 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.5 4.2.4 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein. Such actions may include providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Party’s application for Regulatory Approval of the Licensed Product Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Product or outside of the Territory (if Kiniksa is the Party seeking Regulatory Approval)Territory, as applicable.