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

Rights of Reference and Access to Data. Subject to Section 4.2(ii), each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings and Regulatory Approvals related to the Product (including in the case of Partner, the right to cross-reference Bioprojet’s, its Affiliate’s or 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 Product in the Field in the Partner Territory with respect to Partner and in the Bioprojet Territory with respect to Bioprojet; provided, however, that the Parties expressly acknowledge and agree that, although clause (i) above grants Partner and its Affiliates and Sublicensees the right to cross-reference the DMF and the Data therein, clause (ii) above does not authorize Partner or its Affiliates or Sublicensees to access, or require Bioprojet to disclose, the closed portions of the DMF or the Data therein. Subject to Section 4.2(ii), each Party hereby grants to the other 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 Partner to Commercialize the Product in the Field in the Partner Territory pursuant to this Agreement or by Bioprojet to Develop or Commercialize the Product in the Bioprojet Territory. Each Party or such 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 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 in the Partner Territory or the Bioprojet Territory, as the case may be.

Rights of Reference and Access to Data. Subject to Section 4.2(ii), each Each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings and Regulatory Approvals related to the Product Product(s) (including in the case of PartnerHarmony, the right to cross-reference Bioprojet’s, its Affiliate’s or its subcontractor’s drug master files for Product such Product(s) (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 Product Product(s) in the Field in the Partner Harmony Territory with respect to Partner Harmony and in the Bioprojet Territory with respect to Bioprojet; provided, however, that the Parties expressly acknowledge and agree that, although clause (i) above grants Partner Harmony and its Affiliates and Sublicensees the right to cross-reference the DMF and the Data therein, clause (ii) above does not authorize Partner Harmony or its Affiliates or Sublicensees to access, or require Bioprojet to disclose, the closed portions of the DMF or the Data therein. Subject to Section 4.2(ii), each Each Party hereby grants to the other 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 Partner Harmony to Commercialize the Product Product(s) in the Field in the Partner Harmony Territory pursuant to this Agreement or by Bioprojet to Develop or Commercialize the Product Product(s) in the Bioprojet Territory. Each Party or such 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 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 in the Partner Harmony Territory or the Bioprojet Territory, as the case may be.

Rights of Reference and Access to Data. Subject to Section 4.2(ii)2.4 and 4.7, each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings (and Regulatory Approvals related to the Product (including in the case of PartnerOno, Array’s Third Party Partners’ Regulatory Filings) related to the right to cross-reference Bioprojet’s, its Affiliate’s or its subcontractor’s drug master files for Product (collectively, “DMF”))Products, 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 Product in the Field in the Partner Territory with respect to Partner and in the Bioprojet Territory with respect to BioprojetProduct; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Parties expressly acknowledge and agree thatPerforming Party’s expense in accordance with Section 4.4(c), although clause (i) above grants Partner and its Affiliates and Sublicensees the Non-Performing Party’s right to cross-reference the DMF and the Data therein, clause (ii) above does not authorize Partner or its Affiliates or Sublicensees to accessreference, or require Bioprojet to discloseinclude such Data in its Regulatory Filings for [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the closed portions Securities and Exchange Commission pursuant to Rule 24b-2 of the DMF or Securities Exchange Act of 1934, as amended. Product, shall be subject to compliance with the Data thereincorresponding reimbursement obligation set forth in Section 4.4(c)(ii). Subject to Section 4.2(ii), each Each Party hereby grants to the other Party Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) 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 Partner the other Party to Develop and Commercialize the Product in the Field in the Partner Territory pursuant to this Agreement or by Bioprojet Agreement, subject to Develop or Commercialize the Product in the Bioprojet TerritorySection 4.4(c)(ii) above. Each Party or such Affiliate(s) thereof Affiliate 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 its the 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 in Authority. Each Party will provide, and cause its Affiliates to provide, cooperation to the Partner Territory or other Party to effect the Bioprojet Territory, as the case may beforegoing.

Rights of Reference and Access to Data. (a) Subject to Section 4.2(ii)Article 4.3 below, each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings and Regulatory Approvals related Controlled by the other Party during the term of this Agreement that relates to the Product (including in the case of Partner, the right to cross-reference Bioprojeteach other’s, its and their Affiliate’s or its subcontractorSubcontractor’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 for the sole purpose of 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 Product in the Field in the Partner Territory with respect to Partner and in the Bioprojet Territory with respect to BioprojetProduct; provided, however, that the Parties expressly acknowledge and agree that, although clause (i) above grants Partner and its Affiliates and Sublicensees with respect to Data obtained from new Clinical Studies conducted at the other Party’s expense in accordance with Article 4.3, the non-funding Party’s right to cross-reference reference, or to include such Data in its Regulatory Filings for the DMF Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in that Article, and the Data therein, clause (ii) above does the definition of “Data” shall not authorize Partner include the closed portions of any DMF, nor any information contained in any such portions of a DMF and, notwithstanding any other provision of this Agreement, neither Party shall have any obligation to disclose to the other Party, or any of its Affiliates or Sublicensees to access, or require Bioprojet to discloseSublicensees, the closed portions of such DMFs or any information contained therein, but shall provide to the DMF other Party all necessary or the Data thereinuseful Right of Reference to such closed portion. Subject to Section 4.2(ii)Article 4.3 below, each Party hereby grants to the other Party Party, its Affiliates and Sublicensees, 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 Affiliates that relates to the Product for use by Partner the sole purpose of the performance of its obligations and exercise of its rights under this Agreement, subject to Commercialize the limitations set forth in this Article 4.2(a). With respect to any country within the Non-Encumbered Territory, if during the term of this Agreement, one or more of such countries become an Encumbered Territory, Licensor shall structure any agreement with a Third Party that renders such country(ies) to be an Encumbered Territory so that Licensee has continued access and right to any Data generated with respect to the Product in the Field in the Partner such country(ies) while it was a Non-Encumbered Territory pursuant and for which Licensee had a right under this Article 4.2(a) prior to this Agreement or by Bioprojet to Develop or Commercialize the Product in the Bioprojet such country(ies) becoming an Encumbered Territory. Each Party or such 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 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 in the Partner Territory or the Bioprojet Territory, as the case may be.

Rights of Reference and Access to Data. Subject to Section 4.2(ii)2.4 and 4.7, each Party shall have the right (i) to cross-reference the other Party’s Regulatory Filings (and Regulatory Approvals related to the Product (including in the case of PartnerOno, Array’s Third Party Partners’ Regulatory Filings) related to the right to cross-reference Bioprojet’s, its Affiliate’s or its subcontractor’s drug master files for Product (collectively, “DMF”))Products, 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 Product in the Field in the Partner Territory with respect to Partner and in the Bioprojet Territory with respect to BioprojetProduct; provided, however, that with respect to Data obtained from Declined Clinical Studies conducted at the Parties expressly acknowledge and agree thatPerforming Party’s expense in accordance with Section 4.4(c), although clause (i) above grants Partner and its Affiliates and Sublicensees the Non-Performing Party’s right to cross-reference the DMF and the Data therein, clause (ii) above does not authorize Partner or its Affiliates or Sublicensees to accessreference, or require Bioprojet to discloseinclude such Data in its Regulatory Filings for Product, shall be subject to compliance with the closed portions of the DMF or the Data thereincorresponding reimbursement obligation set forth in Section 4.4(c)(ii). Subject to Section 4.2(ii), each Each Party hereby grants to the other Party Party, its Affiliates and Sublicensees (or in the case of Array, its other licensees) 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 Partner the other Party to Develop and Commercialize the Product in the Field in the Partner Territory pursuant to this Agreement or by Bioprojet Agreement, subject to Develop or Commercialize the Product in the Bioprojet TerritorySection 4.4(c)(ii) above. Each Party or such Affiliate(s) thereof Affiliate 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 its the equivalent as required in any other country or region or otherwise provide [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. appropriate notification of such right of the other Party to the applicable Regulatory Authority in Authority. Each Party will provide, and cause its Affiliates to provide, cooperation to the Partner Territory or other Party to effect the Bioprojet Territory, as the case may beforegoing.