Right of Reference. Subject to the rules of the relevant Regulatory Authority and the terms of 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) (or any successor rule or analogous Applicable Laws recognized outside of the United States) to, and a right to copy, access, and otherwise use, all information and data relating to any [[Unknown Identifier]] Co-Co Product in any Regulatory Material or Regulatory Approval Controlled by such Party during the Term, solely for the other Party’s or its Affiliates’ use in the Development and Commercialization of the [[Unknown Identifier]] Co-Co Products during the Term in accordance with this Agreement. All such information and data contained in any such Regulatory Materials or Regulatory Approvals shall be considered Confidential Information of such Party and subject to the terms of Article 10. If requested by the other Party, such Party shall provide a signed statement to this effect in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Applicable Laws outside of the United States) to give effect to the intent of this [Section 6.9(f)].

Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates in and outside the Territory. Zai may use such right of reference to NVCR’s Regulatory Submissions solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products in the Field in the Territory as NVCR’s authorized legal agent and exclusive general distributor of record or on its own behalf to the extent permitted by Applicable Laws and this Agreement. NVCR may use the right of reference to Zai’s Regulatory Submissions, if any, solely for the purpose of seeking, obtaining and maintaining regulatory approval of Licensed Products outside the Territory or, to the extent permitted pursuant to this Agreement, in the Territory. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference and sharing of data and information pursuant to this Section 6.4.

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Affiliates and Sublicensees, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Applicable Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected, or otherwise generated in the conduct of any Clinical Trials, or early access/named patient programs for any Licensed Candidates or Licensed Products included in or used in support of any regulatory filing, Regulatory Approval, drug master file) or other regulatory documentation (including orphan drug applications and designations) Controlled by such Party or its Affiliates or Sublicensees that relates to any Licensed Candidates or Licensed Products solely for the purpose of # in the case of Licensee, obtaining or maintaining any IND or Regulatory Approval of any Licensed Candidates or Licensed Products (including any Licensee Combination) or # in the case of Relay, obtaining or maintaining any IND or Regulatory Approval for any Relay Pipeline Combination or Relay Pipeline Product. Licensee will provide Relay with copies of Regulatory Materials related to any Relay Pipeline Combination Eligible Licensed Products that are reasonably requested by Relay for use by or on behalf of Relay, its Affiliates or Relay Sublicensees in connection with Developing, Manufacturing or Commercializing any Relay Pipeline Combination as permitted hereunder. In addition, upon the reasonable request of the other Party (on behalf of itself or a Sublicensee), each Party will 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 any successor or analogous Applicable Law outside of the United States) that the other Party may rely on, and the Regulatory Authority may access, in support of the other Party’s application for Regulatory Approval in its Territory, any underlying raw data or information submitted by such Party to the Regulatory Authority with respect to any regulatory submission, Regulatory Approval, drug master file, or other regulatory documentation (including orphan drug applications and designations) Controlled by such Party or its Affiliates or Sublicensees that relates to any Licensed Candidates or Licensed Products or Licensee Combinations or Relay Pipeline Combinations, as applicable. In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of any Licensed Candidates or Licensed Products or Licensee Combinations or Relay Pipeline Combinations, as applicable, in the Territory (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), in each case, as is reasonably necessary for the requesting Party to exercise its rights under this Agreement. Other than for safety concerns, notwithstanding anything in this Agreement to the contrary, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 6.5 unless otherwise mutually agreed by the Parties.

Right of Reference. [[Cellectis:Organization]] hereby grants to Allogene a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by [[Cellectis:Organization]] or its Affiliates # that relates to the Licensed [[Cellectis:Organization]] Intellectual Property, the Agreement CAR-Ts, the Allogene Licensed Products or preclinical studies with respect to the Allogene Licensed Products and # that Allogene reasonably believes may be necessary or useful to the Development, Manufacturing or Commercialization of any Agreement CAR-T or any Allogene Licensed Product pursuant to this Agreement, and [[Cellectis:Organization]] will provide a signed statement to the foregoing effect, if so requested by Allogene in accordance with 21 C.F.R. § 314.50(g)(3).

Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates in and outside the Territory. Zai may use such right of reference to NVCR’s Regulatory Submissions solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products in the Field in the Territory as NVCR’s authorized legal agent and exclusive general distributor of record or on its own behalf to the extent permitted by Applicable Laws and this Agreement. NVCR may use the right of reference to Zai’s Regulatory Submissions, if any, solely for the purpose of seeking, obtaining and maintaining regulatory approval of Licensed Products outside the Territory or, to the extent permitted pursuant to this Agreement, in the Territory. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference and sharing of data and information pursuant to this [Section 6.4].

Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates in and outside the Territory. Zai may use such right of reference to NVCR’s Regulatory Submissions solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products in the Field in the Territory as NVCR’s authorized legal agent and exclusive general distributor of record or on its own behalf to the extent permitted by Applicable Laws and this Agreement. NVCR may use the right of reference to Zai’s Regulatory Submissions, if any, solely for the purpose of seeking, obtaining and maintaining regulatory approval of Licensed Products outside the Territory or, to the extent permitted pursuant to this Agreement, in the Territory. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference and sharing of data and information pursuant to this [Section 6.4].

Right of Reference. Each Party shall have the right, without obtaining the approval of the other Party and without additional payment to such other Party (other than payments expressly provided in this Agreement), to reference (including a “Right of Reference” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule), and corresponding rights under the foreign equivalents of 21 C.F.R. § 314.3(b) in the applicable countries in the Territory), copy, access and use Data, and all reports, documents, Regulatory Filings, and other information developed by any Party that is derived from or includes such Data, in each case, that is related to a Licensed Antibody or Licensed Product and that is owned or Controlled by a Party or its Affiliates # for purposes of preparing and submitting INDs, NDAs, BLAs and other Regulatory Filings for the Licensed Products, and # preparing and filing patent applications, in each case ((a) and (b)) in accordance with this Agreement, and, with respect to such Data, reports, documents and other information developed by the other Party, solely to the extent permitted under this Agreement.

Right of Reference. Each Party will have access and a “Right of Reference,” as that term is defined in 21 C.F.R. §314.3(b) (or any successor rule or analogous law recognized outside of the United States) to all data contained or referenced in any Regulatory Submission and Regulatory Approvals Controlled by the other Party or its Affiliates necessary or reasonably useful for # Betta to exercise the License; and # [[Agenus:Organization]] to exercise its Retained Rights. Each Party will have the right to sublicense its Right of Reference together with a sublicense of the licenses granted to such Party under Section 2.1 or Section 2.4, as applicable. Each Party will bear its own costs and expenses associated with providing the other Party with the Right of Reference and sharing of data and information pursuant to this [Section 4.7(g)].

Right of Reference. To the extent Controlled by a Party, the other Party shall have the right to # cross-reference the Regulatory Approvals and other regulatory documentation specifically related to the Products, # access such Regulatory Approvals and regulatory documentation and any information therein, and # use such information, in each case in connection with the performance of its obligations and exercise of its rights under this Agreement or, in the case of Aguettant, its development and commercialization of products outside the Territory. 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) to any data Controlled by such Party, including any Party’s Regulatory Approvals and regulatory documentation, that specifically relate to a Product for use by the other Party as may be necessary to Develop Products for Commercialization by AcelRx in the Territory pursuant to this Agreement or, in the case of Aguettant, outside the Territory. Each Party shall, or shall cause its Affiliates to, 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 to the applicable Regulatory Authority. For clarity, access to and copies and use of any of the Regulatory Approvals, regulatory documentation and any information therein shall be subject to the terms and conditions of any agreement with a AcelRx or sublicensee of a Party providing access or right of reference pursuant to this Section 4.3; provided that AcelRx shall ensure that each Sublicensee provides the applicable rights to AcelRx so that AcelRx may grant such rights to Aguettant under this Section 4.3.

Right of Reference. Each Party hereby grants to the other Party and its Related Parties a right of reference to all Regulatory Filings pertaining to the Product in the Field submitted by or on behalf of such Party and/or its Related Parties, as applicable. Newsoara and its Related Parties may use such right of reference to vTv’s and its Related Parties’ Regulatory Filings in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Product in the Field in the Territory. vTv and its Related Parties may use such right of reference to Newsoara’s and its Related Parties’ Regulatory Filings in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of any Product outside the Territory.