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. (a) Adapt shall have the right to cross-reference Lightlake’s or its Affiliate’s Regulatory Approvals and Regulatory Documentation related to Products, and to access such Regulatory Approvals and Regulatory Documentation and any data and know-how therein and use such data and know-how, in each case in connection with the performance of its obligations and exercise of its rights under this Agreement. Lightlake hereby grants to Adapt 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 jurisdiction, to any data, including Lightlake’s or its Affiliates’ Regulatory Approvals and Regulatory Documentation, that relate to a Product for use by Adapt to Develop and Commercialize Products pursuant to this Agreement. Lightlake or such Affiliate shall provide a signed statement to this effect, if requested by Adapt, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any other jurisdiction or otherwise provide appropriate notification of such right of Adapt to the applicable Regulatory Authority.
Rights of Reference and Access to Data. Each Party shall have the right to cross-reference the other Party’s or its Affiliate’s DMF, if any, and other Regulatory Filings anywhere in the 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, in each case in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data and Know-How in its own Regulatory Filings for the Licensed Products. Each Party hereby grants to the other 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 jurisdiction, to any Data, including such Party’s or its Affiliates’ Regulatory Dossiers, Controlled by such Party or such Affiliates that relate to a Licensed Product for use by such other Party to Develop and Commercialize the Licensed Products in the Field pursuant to this Agreement. 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 other jurisdiction or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority.
Rights of Reference and Access to Data. (i) [***]
Rights of Reference and Access to Data. Each Party and its Affiliates shall have the right to cross-reference the other Party’s or its Affiliate’s drug master file (“DMF”), if any, and any other Regulatory Filings or information supporting Pricing and Reimbursement Approval anywhere in the world, in each case, to the extent such files, filings and support relate to Licensed Compounds or Products in the Field, and to access such Regulatory Filings and any Data and other Know-How therein and use such Data and Know-How in connection with the performance of its obligations and exercise of its rights under this Agreement, including inclusion of such Data and other Know-How in its own Regulatory Filings and filings for Pricing and Reimbursement Approvals for Products in accordance with this Agreement. Each Party hereby grants to the other 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 region of the Territory, to any Data included in a Regulatory Filing or filing for Pricing and Reimbursement Approval for a Product for use by the other Party to Develop and Commercialize the Products in the Field pursuant to this Agreement. 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.
Rights of Reference and Access to Data. Chiesi shall (and does hereby) grant to Protalix a non-exclusive “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), or an equivalent non-exclusive right of access/reference in the United States and in the EU and in each other Country in the Territory (A) solely for use by Protalix in connection with the Development and/or Commercialization of any Licensed Product outside of the Territory or any New Use (or other drug product containing the Drug Substance outside of the Field), to any data in any regulatory filing in the EU or any other Country in the Territory Controlled by Chiesi that relates to the Drug Substance or Licensed Product, and (B) solely for use by Protalix in connection with the Development of drug products made using the System, to any safety data (but not efficacy data) in any regulatory filing in the EU or any other Country in the Territory Controlled by Chiesi that relates to the Drug Substance or Licensed Product. Chiesi shall provide a signed statement to this effect, if requested by Protalix, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in the EU or any other Country in the Territory, or otherwise provide appropriate notification of such right of Protalix to the applicable Regulatory Authority. To the extent Chiesi shall need an equivalent “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), to exploit the rights granted hereunder in the Territory, Protalix shall (and does hereby) grant to Chiesi a non-exclusive Right of Reference, or an equivalent non-exclusive right of access/reference in the United States and in the EU and in each other Country in the Territory, solely for use by Chiesi in connection with the Development and/or Commercialization of the Licensed Product in the Field in the Territory, and solely if and to the extent that Chiesi is authorized under this Agreement to conduct such Development and/or Commercialization, (A) to any data in any regulatory filing Controlled by Protalix that relates to the Drug Substance or Licensed Product, and (B) to any safety data (but not efficacy data) in any regulatory filing that relates to the Drug Substance or Licensed Product. Protalix shall provide a signed statement to this effect, if requested by Chiesi, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in the EU or any other Country in the Territory, or otherwise provide appropriate notification of such right of Chiesi to the applicable Re...
Rights of Reference and Access to Data. Xxxxxxx shall have a Right of Reference to Geron’s or its Affiliate’s drug master file, if any, and any other Regulatory Filings (whether made before or during the Term hereof) Controlled by Geron anywhere in the world related to any Licensed Products, and Xxxxxxx shall also have a right to review, access and request copies of such Regulatory Filings and any Know-How (including data) therein and use such Know-How in connection with the performance of Xxxxxxx’x obligations and exercise of its rights under this Agreement, including inclusion of such Know-How in its own Regulatory Filings for Licensed Products; provided, however, that with respect to Know-How obtained from a trial conducted under an IDP at Geron’s expense in accordance with Section 4.9 above, Xxxxxxx’x right to cross-reference or include such Know-How obtained at Geron’s expense shall be subject to satisfaction of the payment obligation set forth in Section 4.9.4, if applicable. Geron hereby grants to Xxxxxxx 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 region of the world, to any Regulatory Filing, including Geron’s or its Affiliate’s clinical dossiers, Controlled by Geron that relates to any Licensed Product, for use by Xxxxxxx in exploitation of its Development and Commercialization rights relating to Licensed Products in the Field pursuant to this Agreement. Geron or its Affiliate shall provide a signed statement to this effect, if requested by Xxxxxxx, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any other country or region of the world, or otherwise provide appropriate notification of such right of Xxxxxxx to the applicable Regulatory Authority. In the event Geron conducts any Development activities under a Geron IDP, Geron shall have a similar Right of Reference to Regulatory Filings Controlled by Xxxxxxx and Know-How therein solely to the extent needed for purposes of conducting Geron’s activities under the Geron IDP, in the same manner as such rights are granted to Xxxxxxx under this Section 4.12, and this Section 4.12 shall apply to the Parties with respect thereto, mutatis mutandis.
Rights of Reference and Access to Data. Each Party shall have the right to cross-reference the other Party’s or its Affiliate’s drug master file (“DMF”) and/or IND, if any, and any other Regulatory Filings anywhere in the world related to Cost Profit Sharing Products (and, for clarity, GSK shall also have the right to cross-reference such filings with respect to any Opt Out Products it is Developing and/or Commercializing), [***]. Each Party hereby grants to the other 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 the United States or in any other country or region of the OUS Territory, to any Data, including such Party’s or its Affiliate’s clinical dossiers, Controlled by such Party or such Affiliate that relates to a Cost Profit Sharing Products for use by the other Party to Develop and Commercialize the Cost Profit Sharing Products (and with respect to GSK, any Licensed Product) in the Field pursuant to this Agreement. 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 the United States or any country or region of the OUS Territory or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority.
Rights of Reference and Access to Data. Each Party shall have the right to cross-reference the other Party’s or its Affiliate’s drug master file (“DMF”) and/or IND, if any, and any other Regulatory Filings anywhere in the world related to Collaboration Product, and to access such Regulatory Filings and any Data and Know-How therein and use such Data and Know-How, in each case, solely in connection with its Development, Manufacturing and Commercialization activities under this Agreement with respect to the Collaboration Product (or New Collaboration Product in the case of Taiho), including inclusion of such Data and Know-How in its own Regulatory Filings for the Collaboration Product (or New Collaboration Product in the case of Taiho) made in accordance with this Agreement. Each Party hereby grants to the other 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 the United States or in any other country or region of the OUS Territory, to any Data, including such Party’s or its Affiliate’s clinical dossiers, controlled by such Party or such Affiliate that relates to a Collaboration Product for use by the other Party to Develop, Manufacture and Commercialize the Collaboration Product (or New Collaboration Product in the case of Taiho) in the Field in accordance with this Agreement. 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 the United States or any country or region of the OUS Territory or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority.
Rights of Reference and Access to Data. Xxxxxxx shall have a Right of Reference to Achillion’s or its Affiliate’s drug master file, if any, and any other Regulatory Filings (whether made before or during the Term hereof) Controlled by Achillion anywhere in the world relating to any Achillion Single APIs or Licensed Products, and Xxxxxxx shall also have a right to review, access and request copies of such Regulatory Filings and any Know-How (including data) therein and use such Know-How in connection with the performance of Xxxxxxx’x obligations and exercise of its rights under this Agreement, including inclusion of such Know-How in its own Regulatory Filings for Single Agents or Licensed Products. Achillion hereby grants to Xxxxxxx a Right of Reference to any Regulatory Filing, including Achillion’s or its Affiliate’s clinical dossiers, Controlled by Achillion that relates to any Achillion Single API or Licensed Product, for use by Xxxxxxx in exploitation of its Development and Commercialization rights relating to Licensed Products in the Field pursuant to this Agreement. Achillion or its Affiliate shall provide a signed statement to this effect, if requested by Xxxxxxx, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any other country or region of the world, or otherwise provide appropriate notification of such right of Xxxxxxx to the applicable Regulatory Authority.
