Common use of Right of Reference Clause in Contracts

Right of Reference. 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 (in case of BioCryst) or Controlled Affiliates (in case of Torii). Torii may use such right of reference to BioCryst’s Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer Date. BioCryst may use such right of reference to Torii’s Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Reimbursement Approvals of the Licensed Product outside of the Territory or in the Territory outside of the Field. Each Party will bear its own costs and expenses associated with providing the other Party the right of reference pursuant to this Section 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 3.5 (Right of Reference) and to give the other Party the benefit of the granting Party’s Regulatory Submissions 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 ▇▇▇▇ or applications for Reimbursement Approval for the Licensed Product in the Field in the Territory (if 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 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. 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 in the Territory submitted by or on behalf of such Party or its Affiliates. Licensee will grant, and hereby does grant, to Akebia and its Affiliates, licensees (including [**]), and Sublicensees a right of reference to all Licensee Development Data developed in Licensee’s activities under this Agreement. Licensee and its Affiliates (in case of BioCryst) or Controlled Affiliates (in case of Torii). Torii and Sublicensees may use such right of reference to BioCrystAkebia’s Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer DateTerritory. BioCryst Akebia and its Affiliates, licensees, and Sublicensees may use such right of reference to ToriiLicensee’s Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Reimbursement Approvals of the Licensed Product outside of the Territory or in the Territory outside of the FieldTerritory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 3.5 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 3.5 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 (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 ▇▇▇▇ or applications application for Reimbursement Regulatory Approval for of the Licensed Product in the Field Products in the Territory (if 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 BioCryst is the Party seeking Regulatory Approval or Reimbursement Approval)Territory, 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)as applicable.

Right of Reference. Each 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 in the Territory submitted by or on behalf of such Party or its Affiliates Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in case the Territory, and (b) to Regulatory Submissions submitted by or on behalf of BioCryst) or Controlled Affiliates (in case Partner is exclusive to Kiniksa outside of Torii)the Territory. Torii Partner may use such right of reference to BioCrystKiniksa’s Regulatory Submissions solely for the purpose of seekingto seek, obtainingobtain, supportingsupport, and maintaining maintain ​ ​ Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer DateTerritory. BioCryst Kiniksa may use such right of reference to ToriiPartner’s Regulatory Submissions Submissions, if any, solely for the purpose of seekingto seek, obtainingobtain, supportingsupport, and maintaining maintain Regulatory Approval and any Reimbursement Approvals of for the Licensed Product outside of the Territory or in the Territory outside of the FieldTerritory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 3.5 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 3.5 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 (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 ▇▇▇▇ or applications application for Reimbursement Regulatory Approval for of the Licensed Product in the Field in the Territory (if Torii Partner 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 BioCryst Kiniksa 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. Each 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 Product Products in the Field in the Territory submitted by or on behalf of such Party or its Affiliates Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of ImmunoGen is exclusive to Partner in case the Territory, and (b) to Regulatory Submissions submitted by or on behalf of BioCryst) or Controlled Affiliates (in case Partner is exclusive to ImmunoGen outside of Torii)the Territory. Torii Partner may use such right of reference to BioCrystImmunoGen’s Regulatory Submissions solely for the purpose of seekingperforming Development activities for the Licensed Products in accordance with this Agreement and the Global Development Plan or Territory Development Plan and to seek, obtainingobtain, supportingsupport, and maintaining maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product Products in the Field in the Territory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer DateTerritory. BioCryst ImmunoGen may use such right of reference to ToriiPartner’s Regulatory Submissions Submissions, if any, solely for the purpose of seekingDeveloping the Licensed Products and to seek, obtainingobtain, supportingsupport, and maintaining maintain Regulatory Approval and any Reimbursement Approvals of for the Licensed Product Products outside of the Territory or in the Territory outside of the FieldTerritory. Each Party will bear its own costs and expenses [***] associated with providing the other Party with the right of reference pursuant to this Section 3.5 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 3.5 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 (ai) 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 ▇▇▇▇ or applications application for Reimbursement Regulatory Approval for of the Licensed Product in the Field Products in the Territory (if Torii Partner is the Party seeking Regulatory Approval or Reimbursement Approval) and of the Licensed Product Products outside of the Territory or in the Territory outside of the Field (if BioCryst ImmunoGen is the Party seeking Regulatory Approval or Reimbursement Approval), or (bii) 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 any 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)Product.

Right of Reference. Each 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 in the Territory submitted by or on behalf of such Party or its Affiliates Affiliates, which right of reference (a) to Regulatory Submissions submitted by or on behalf of Kiniksa is exclusive to Partner in case the Territory, and (b) to Regulatory Submissions submitted by or on behalf of BioCryst) or Controlled Affiliates (in case Partner is exclusive to Kiniksa outside of Torii)the Territory. Torii Partner may use such right of reference to BioCrystKiniksa’s Regulatory Submissions solely for the purpose of seekingto seek, obtainingobtain, supportingsupport, and maintaining maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product in the Field in the Territory in accordance with the terms of this Agreement following the Regulatory Responsibility Transfer DateTerritory. BioCryst Kiniksa may use such right of reference to ToriiPartner’s Regulatory Submissions Submissions, if any, solely for the purpose of seekingto seek, obtainingobtain, supportingsupport, and maintaining maintain Regulatory Approval and any Reimbursement Approvals of for the Licensed Product outside of the Territory or in the Territory outside of the FieldTerritory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 3.5 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 3.5 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 (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 ▇▇▇▇ or applications application for Reimbursement Regulatory Approval for of the Licensed Product in the Field in the Territory (if Torii Partner 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 BioCryst Kiniksa 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. Each Subject to Section 5.3 (Clinical Studies), 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 Product Compound and Products to the extent necessary or useful for such other Party (a) in the case of Sobi, its Affiliates, and its Sublicensees, to Develop, conduct Packaging and Labeling, and Commercialize the Products in the Field in the Territory submitted by Sobi Territory, and, upon Sobi notifying ADCT in writing that Sobi desires to assume the responsibility and obligation to Manufacture or on behalf of such Party have Manufactured the Compound or its Affiliates (in case of BioCryst) or Controlled Affiliates (in case of Torii). Torii may use such right of reference to BioCryst’s Regulatory Submissions solely Products for the purpose of seekingSobi Territory-Specific Supply pursuant to Section 8.5 (Supply by Sobi), obtaining, supporting, to Manufacture the Compound and maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Product Products in the Field in the Sobi Territory and the ADCT Territory, in accordance with this Agreement, and (b) in the terms case of this Agreement following ADCT, its Affiliates, and its licensees, to Develop, Manufacture, and Commercialize the Regulatory Responsibility Transfer DateCompound and Products in any field in any country in the ADCT Territory. BioCryst 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 Toriiother Party’s Regulatory Submissions solely Filings, and 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 the purpose of seekingapplying, obtaining, supporting, obtaining and maintaining Regulatory Approval and any Reimbursement Approvals for the Products in accordance with such Party’s standard operating procedures or as reasonably requested in writing by the other Party for purposes of the Licensed Product outside of the Territory or other Party’s compliance with Applicable Law in the Territory outside of the FieldTerritory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 3.5 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 3.5 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 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 ▇▇▇▇ or applications for Reimbursement Approval for the Licensed Product in the Field in the Territory (if 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 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).