Common use of Right of Reference Clause in Contracts

Right of Reference. Except with respect to the New Development of any Licensed Product for a Global Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development 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 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 ImmunoGen is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen outside of the Territory. Partner may use such right of reference to ImmunoGen’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 Products in the Field in the Territory. 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 Products outside of the Territory. Each Party will [***] 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 Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products outside of the Territory (if 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 Subject to the New Development of any Licensed Product for a Global Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development Costs)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 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 ImmunoGen 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 ImmunoGen outside of the Territory. Partner may use such right of reference to ImmunoGen’s Regulatory Submissions solely for the purpose of performing Development activities for Develop, Manufacture, and Commercialize the Licensed Compound and 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 Products field in any country in the Field in the Territory. 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 Products outside of the ADCT Territory. Each Party will [***] 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 (i) 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 the Licensed Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products outside of the Territory (if 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 conduct reasonable quality assurance audits with respect to any Regulatory Submissions Controlled by such granting Party or its Affiliates that relates the said Data to any Licensed Productverify conformance with Applicable Laws.

Right of Reference. Except with respect to the New Development of any Licensed Product for a Global Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development Costs), each a) Each Party will grant, and hereby does grant, grants to the other Party a the right of reference to all Regulatory Submissions pertaining to the Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates, which solely to the extent reasonably necessary for the purposes set forth in this Section 6.3 and requested by such other Party. In addition, BeiGene hereby grants to Zymeworks the right of reference (a) to Regulatory Submissions all regulatory submissions pertaining to Tisle Products submitted by or on behalf of ImmunoGen is exclusive BeiGene or its Affiliates or licensees, solely to Partner the extent reasonably necessary for the purposes set forth in the Territory, this Section 6.3 and requested by Zymeworks. (b) to Regulatory Submissions submitted by BeiGene may, itself or on behalf of Partner is exclusive to ImmunoGen outside of the Territory. Partner may through its Affiliates, sublicensees and licensees, use such right of reference to ImmunoGen’s Zymeworks’ Regulatory Submissions solely for the purpose purposes of performing Development activities for the Licensed Products in accordance with this Agreement seeking, obtaining and the Global Development Plan or Territory Development Plan and to seek, obtain, support, and maintain maintaining Regulatory Approvals Approval and any Reimbursement Approvalspricing or reimbursement approvals, as 7 Competitive Information – Commercially Sensitive Terms. 8 Competitive Information – Commercially Sensitive Terms. applicable, for the of (i) Licensed Products in the Field in the Territory. ImmunoGen may Territory or (ii) Tisle Product for use in combination with the Licensed Product. (c) Zymeworks may, itself or through its Affiliates and licensees, use such right of reference to PartnerBeiGene’s Regulatory Submissions, if any, Submissions and Regulatory Approvals solely for the purpose of Developing the Licensed Products seeking, obtaining and to seek, obtain, support, and maintain maintaining Regulatory Approval and any Reimbursement Approvals for the of Licensed Products outside of the Territory or, to the extent permitted pursuant to this Agreement, in the Territory. Each Without limiting the foregoing, Zymeworks may, itself or through its Affiliates and licensees, use such right of reference to BeiGene’s regulatory submissions and Regulatory Approvals for Tisle Product (a) to support Regulatory Submissions for the Tisle Combination Studies outside of the Territory and, to the extent permitted, in the Territory and (b) for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products for use in combination with Tisle Product outside the Territory. (d) The Party will [***] requesting such right of reference shall bear the reasonable costs and expenses of the other Party associated with providing the other Party with the right of reference pursuant to this Section 6.5 (Right of Reference)6.3. 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) 6.3 and to give the other Party the benefit of the rights of reference to the granting Party’s Regulatory Submissions regulatory submissions in the other Party’s territory as provided herein.” 10. 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 Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products outside of the Territory (if ImmunoGen is the Party seeking Regulatory ApprovalSection 7.3(a), 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 any Licensed Product for a Global Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development Costs), 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 Products 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 ImmunoGen is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen outside of the TerritoryTorii). Partner Torii may use such right of reference to ImmunoGenBioCryst’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 seekseeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Products Product in the Field in the TerritoryTerritory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer Date. ImmunoGen BioCryst may use such right of reference to PartnerTorii’s Regulatory Submissions, if any, Submissions solely for the purpose of Developing the Licensed Products and to seekseeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approval and any Reimbursement Approvals for of the Licensed Products 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 (ia) 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 Products Product in the Field in the Territory (if Partner Torii is the Party seeking Regulatory Approval or Reimbursement Approval) and of the Licensed Products Product outside of the Territory or in the Territory outside of the Field (if ImmunoGen BioCryst is the Party seeking Regulatory Approval or Reimbursement Approval), or (iib) 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 Licensed Productprovision 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 to the New Development of any 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), 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 Products 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 ImmunoGen Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen Kiniksa outside of the Territory. Partner may use such right of reference to ImmunoGenKiniksa’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 Products Product in the Field in the Territory. ImmunoGen Kiniksa 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 Products 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 (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 Products Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products Product outside of the Territory (if ImmunoGen Kiniksa 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 Subject to the New Development of any Licensed Product for a Global Section 5.3 (Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development CostsStudies), each Party will grant, and hereby does grant, grants to the other Party Party, its Affiliates, and its licensees and 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, in each case, relating to the Licensed Compound and Products to the extent necessary or useful for such other Party (a) in the Field submitted by or on behalf case of such Party or Sobi, its Affiliates, which right of reference (a) and its Sublicensees, to Regulatory Submissions submitted by or on behalf of ImmunoGen is exclusive to Partner in the TerritoryDevelop, conduct Packaging and Labeling, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen outside of Commercialize the Territory. Partner may use such right of reference to ImmunoGen’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 Products in the Field in the Sobi Territory, and, upon Sobi notifying ADCT in writing that Sobi desires to assume the responsibility and obligation to Manufacture or have Manufactured the Compound or Products for the Sobi Territory-Specific Supply pursuant to Section 8.5 (Supply by Sobi), to Manufacture the Compound and Products in the Field in the Sobi Territory and the ADCT Territory, in accordance with this Agreement, and (b) in the case of ADCT, its Affiliates, and its licensees, to Develop, Manufacture, and Commercialize the Compound and Products in any field in any country in the ADCT Territory. ImmunoGen Each Party shall provide a signed statement to the other Party that such other Party may use rely on, in support of the approval of such right of reference to Partnerother Party’s Regulatory SubmissionsFilings, if anyand provide the applicable Regulatory Authority access to (i) the underlying raw data included in such Regulatory Filings and marketing authorizations Controlled by such Party and (ii) the underlying raw data Controlled by such Party included in such Regulatory Filings and marketing authorizations Controlled by such other Party. Each Party shall store the relevant Data and information Controlled by such Party to be used for applying, solely obtaining and maintaining Regulatory Approval for the purpose Products in accordance with such Party’s standard operating procedures or as reasonably requested in writing by the other Party for purposes of Developing the Licensed Products and to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Products outside of other Party’s compliance with Applicable Law in 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 2.14 (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 2.14 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions Filings in the other Party’s territory 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 Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products outside of the Territory (if 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 any Licensed Product for a Global Clinical Trial for which Partner [***] as set forth under Section 5.5.3 (Partner Sharing of Development Costs), each Each Party will grant, and hereby does grant, to the other Party a right of reference to all Regulatory Submissions Approvals and Regulatory Materials pertaining to the Licensed Products in the Field Controlled and submitted by or on behalf of such Party or its Affiliates, which subject to payment of any amounts agreed in writing by the Parties or specified to be due under Section 4.2 (Ongoing JS001 Clinical Trials) through and including Section 4.6 (Development of Optioned Licensed Products), as applicable, to obtain such right of reference (a) to Regulatory Submissions submitted by or on behalf of ImmunoGen is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen outside of the Territoryreference. Partner Coherus may use such right of reference to ImmunoGen’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 such Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Products in the Field in the Territory. ImmunoGen may use such right of reference to Partner’s Regulatory SubmissionsMaterials Controlled by Junshi or its Affiliates, if any, solely for the purpose of Developing the Licensed Products and to seekseeking, obtainobtaining, supportsupporting, and maintain maintaining Regulatory Approval and any Pricing and Reimbursement Approvals for of the Licensed Products outside of in the Coherus Territory. Each Junshi may use such right of reference to such Regulatory Approvals and Regulatory Materials Controlled by Coherus or any of its Affiliates solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Pricing and Reimbursement Approvals of (a) the Licensed Products in the Junshi Territory and (b) any product Controlled by Junshi that is included in any Combination Regimen in the Coherus Territory. The Party using such right of reference will [***] bear (i) its own costs and expenses and (ii) the reasonable and verifiable costs and expenses incurred by the other Party associated with providing the other Party with assistance to enable such use of the right of reference pursuant to this Section 6.5 5.5 (Right of Reference), including (A) internal costs (calculated at the FTE Rate) reasonably incurred by or on behalf of the other Party or its Affiliates in connection with such activities, and (B) all verifiable external or out- of-pocket costs reasonably incurred by or on behalf of the other Party or its Affiliates in connection with such activities under this Section 5.5, in each case ((A) and (B)), within 45 days after receiving the invoice therefor. 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 5.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions Approvals and Regulatory Materials in the other Party’s territory as provided herein. Such actions may include (i) providing , including by executing any letters of authorization or similar correspondence for submitting to an applicable Regulatory Authority to further evidence or give effect 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 Products in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products outside of the Territory (if 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.rights contemplated hereby. ​

Right of Reference. Except with respect to the New Development of any 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), 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 Products 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 ImmunoGen Kiniksa is exclusive to Partner in the Territory, and (b) to Regulatory Submissions submitted by or on behalf of Partner is exclusive to ImmunoGen Kiniksa outside of the Territory. Partner may use such right of reference to ImmunoGenKiniksa’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 Products Product in the Field in the Territory. ImmunoGen Kiniksa 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 Products 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 (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 Products Product in the Territory (if Partner is the Party seeking Regulatory Approval) and of the Licensed Products Product outside of the Territory (if ImmunoGen Kiniksa 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.