Common use of Rights of Reference and Access to Data Clause in Contracts

Rights of Reference and Access to Data. Subject to Section 2.4 and 4.7, each Party shall have the right to cross-reference the other Party’s Regulatory Filings (and in the case of Ono, Array’s Third Party Partners’ Regulatory Filings) related to the Products, and to access such Regulatory Filings and any Data therein and use such Data in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data in its own Regulatory Filings for Product; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Performing Party’s expense in accordance with Section 4.4(c), the Non-Performing Party’s right to cross-reference, or to include such Data in its Regulatory Filings for Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in Section 4.4(c)(ii). Each Party hereby grants to the other Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other country or region, to any Data, including such Party’s or its Affiliate’s clinical dossiers, Controlled by such Party or such Affiliate that relates to the Product for use by the other Party to Develop and Commercialize the Product in the Field pursuant to this Agreement, subject to Section 4.4(c)(ii) above. Each Party or such Affiliate shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority. Each Party will provide, and cause its Affiliates to provide, cooperation to the other Party to effect the foregoing.

Rights of Reference and Access to Data. Subject to Section 2.4 and 4.74.2(ii), each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings and Regulatory Approvals related to the Product (and including in the case of OnoPartner, Arraythe right to cross-reference Bioprojet’s, its Affiliate’s Third Party Partners’ Regulatory Filings) related to the Productsor its subcontractor’s drug master files for Product (collectively, “DMF”)), and (ii) to access such Regulatory Filings and Regulatory Approvals and any Data therein and use such Data in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data in its own Regulatory Filings and Regulatory Approvals for ProductProduct in the Field in the Partner Territory with respect to Partner and in the Bioprojet Territory with respect to Bioprojet; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Performing Party’s expense in accordance with Section 4.4(c)Parties expressly acknowledge and agree that, although clause (i) above grants Partner and its Affiliates and Sublicensees the Non-Performing Party’s right to cross-referencereference the DMF and the Data therein, clause (ii) above does not authorize Partner or its Affiliates or Sublicensees to access, or require Bioprojet to include such disclose, the closed portions of the DMF or the Data in its Regulatory Filings for Producttherein. Subject to Section 4.2(ii), shall be subject to compliance with the corresponding reimbursement obligation set forth in Section 4.4(c)(ii). Each each Party hereby grants to the other Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) Party a “Right of Reference,” as that term is defined in United States 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other country or region, to any Data, including such Party’s or its Affiliate’s clinical dossiers, Controlled by such Party or such Affiliate that relates to the Product for use by the other Party Partner to Develop and Commercialize the Product in the Field in the Partner Territory pursuant to this Agreement, subject Agreement or by Bioprojet to Section 4.4(c)(ii) aboveDevelop or Commercialize the Product in the Bioprojet Territory. Each Party or such Affiliate Affiliate(s) thereof shall provide a signed statement to this effect, if requested by the other Party, in accordance with United States 21 C.F.R. § 314.50(g)(3) or the its equivalent as required in any other country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority. Each Party will provideAuthority in the Partner Territory or the Bioprojet Territory, and cause its Affiliates to provide, cooperation to as the other Party to effect the foregoingcase may be.

Rights of Reference and Access to Data. Subject to Section 2.4 and 4.7, each Each Party shall have the right to cross-reference the other regulatory filings and Regulatory Approvals (and, to the extent permissible by the Related Party, each Party’s Related Party’s regulatory filings and Regulatory Filings (and in the case of Ono, Array’s Third Party Partners’ Regulatory FilingsApprovals) related to the Licensed Products, and to access such regulatory filings and such Regulatory Filings Approvals and any Data therein and use such Data in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data in its own Regulatory Filings regulatory filings for Product; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Performing Party’s expense in accordance with Section 4.4(c), the Non-Performing Party’s right to cross-reference, or to include such Data in its Regulatory Filings for Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in Section 4.4(c)(ii)a Licensed Product free of charge. Each Party hereby grants will grant, and, subject to Section 7.1.3, will use Commercially Reasonable Efforts to cause its Related Party to grant, to the other Party, Party and its Affiliates and Sublicensees (or in the case of Array, its other licensees) Related Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other country or region, to any Data, including such Party’s or its AffiliateRelated Party’s clinical dossiers, Controlled by such Party or such Affiliate Related Party that relates to the Licensed Product for use by the other Party to Develop and Commercialize the Licensed Product in the Field pursuant to this Agreement. To the extent permitted by applicable law, subject to Section 4.4(c)(ii) above. Each each Party or such Affiliate shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory AuthorityAuthority and, subject to Section 7.1.3 shall use Commercially Reasonable Efforts to cause its Related Party to provide such signed statement. Each Party will provide, and shall use Commercially Reasonable Efforts to cause its Affiliates Related Party to provide, cooperation to the other Party to effect the foregoing.

Rights of Reference and Access to Data. Subject to Section 2.4 and 4.7, each Each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings and Regulatory Approvals related to the Product(s) (and including in the case of OnoHarmony, Arraythe right to cross-reference Bioprojet’s, its Affiliate’s Third Party Partners’ Regulatory Filingsor its subcontractor’s drug master files for such Product(s) related to the Products(collectively, “DMF”)), and (ii) to access such Regulatory Filings and Regulatory Approvals and any Data therein and use such Data in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data in its own Regulatory Filings and Regulatory Approvals for ProductProduct(s) in the Field in the Harmony Territory with respect to Harmony and in the Bioprojet Territory with respect to Bioprojet; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Performing Party’s expense in accordance with Section 4.4(c)Parties expressly acknowledge and agree that, although clause (i) above grants Harmony and its Affiliates and Sublicensees the Non-Performing Party’s right to cross-referencereference the DMF and the Data therein, clause (ii) above does not authorize Harmony or its Affiliates or Sublicensees to access, or require Bioprojet to include such disclose, the closed portions of the DMF or the Data in its Regulatory Filings for Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in Section 4.4(c)(ii)therein. Each Party hereby grants to the other Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) Party a “Right of Reference,” as that term is defined in United States 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other country or region, to any Data, including such Party’s or its Affiliate’s clinical dossiers, Controlled by such Party or such Affiliate that relates to the Product Product(s) for use by the other Party Harmony to Develop and Commercialize the Product Product(s) in the Field in the Harmony Territory pursuant to this Agreement, subject Agreement or by Bioprojet to Section 4.4(c)(iiDevelop or Commercialize the Product(s) abovein the Bioprojet Territory. Each Party or such Affiliate Affiliate(s) thereof shall provide a signed statement to this effect, if requested by the other Party, in accordance with United States 21 C.F.R. § 314.50(g)(3) or the its equivalent as required in any other country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority. Each Party will provideAuthority in the Harmony Territory or the Bioprojet Territory, and cause its Affiliates to provide, cooperation to as the other Party to effect the foregoingcase may be.

Rights of Reference and Access to Data. Subject to Section 2.4 and 4.7, each Each Party shall have the right to cross-reference the other Party’s or its Affiliate’s drug master file, if any, and any other ​ [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. ​ ​ Regulatory Filings (and anywhere in the case of Ono, Array’s Third Party Partners’ Regulatory Filings) world related to the Licensed Products, and to access such Regulatory Filings and any Data and Know-How therein and use such Data and Know-How solely in connection with the performance of its obligations and exercise of its rights under this Agreement in accordance with the Data Protection Agreement, including inclusion of such Data and Know-How in its own Regulatory Filings for Product; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Performing Party’s expense in accordance with Section 4.4(c), the Non-Performing Party’s right to cross-reference, or to include such Data in its Regulatory Filings for Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in Section 4.4(c)(ii)Licensed Products. Each Party hereby grants to the other Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the United States, or an equivalent exclusive right of access/reference in any other country or regionregion in the Territory, to any Data, including such Party’s or its Affiliate’s clinical dossiers, Controlled by such Party or such Affiliate that relates to the Product Licensed Products for use by the other Party to Develop Develop, Manufacture and Commercialize the Product Licensed Products in the Field pursuant to this Agreement, subject to Section 4.4(c)(ii) above. Each Party or such Affiliate shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any country or region of the Territory or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority. Each Party will provide, and cause its Affiliates to provide, cooperation to the other Party to effect the foregoing.