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. (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.
(b) Upon and subject to the Parties’ mutual written agreement upon commercially reasonable terms, Adapt shall (a) grant Lightlake the right to cross-reference Adapt’s or its Affiliate’s or Commercial Sublicensee’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 development, manufacture, use, and/or commercialization of intranasal products containing naloxone (other than Products) and (b) grant Lightlake 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 Adapt’s or its Affiliates’ or Commercial Sublicensee’s Regulatory Approvals and Regulatory Documentation, that relate to a Product for use by Lightlake to development, manufacture, use, and/or commercialization of intranasal products containing naloxone (other than Products). For the sake of clarity, this Section 3.3(b) shall be of no force or effect unless and until the Parties agree in writing on the terms of such foregoing rights. Notwithstanding the foregoing, Adapt shall promptly provide Lightlake the Pharmacokinetic Data upon it becoming available, provided that Lightlake shall...
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. 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 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.
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. (a) Subject to Article 4.3 below, each Party shall have the right to cross-reference the Regulatory Filings Controlled by the other Party during the term of this Agreement that relates to the Product (including each other’s, and their Affiliate’s or Subcontractor’s DMF), and to access such Regulatory Filings and any Data 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 for the Product; provided, however, that (i) 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, or to include such Data in its Regulatory Filings for the Product, shall be subject to compliance with the corresponding reimbursement obligation set forth in that Article, and (ii) the definition of “Data” shall not 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, the closed portions of such DMFs or any information contained therein, but shall provide to the other Party all necessary or useful Right of Reference to such closed portion. Subject to Article 4.3 below, each Party hereby grants to the other Party, its Affiliates and Sublicensees, 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 Affiliates that relates to the Product for the sole purpose of the performance of its obligations and exercise of its rights under this Agreement, subject to 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 such country(ies) while it was a Non-Encumbered Territory and for which Licensee had a right under this Article 4.2(a) prior to such country(...
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 16 EAST\151813552.1 Exhibit 10.1 Confidential Treatment has been granted for portions of this exhibit. The copy filed herewith omits certain information subject to the confidentiality request. Omissions are designated as “****”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 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 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. Subject to Section 7.1.3, each Party shall have the right to cross-reference the regulatory filings and Regulatory Approvals (and each Party’s Related Party’s regulatory filings and Regulatory Approvals) related to the Licensed Products, and to access such regulatory filings and such 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 for a Licensed Product free of charge. Each Party hereby will grant, and will cause its Related Party to grant, to the other Party and its 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 Related Party’s clinical dossiers, Controlled by such Party or such 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. Each Party 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 and shall cause its Related Party to provide such signed statement. Each Party will provide, and will cause its Related Party to provide, cooperation to the other Party to effect the foregoing.
