Right of Reference or Use Clause Samples
The Right of Reference or Use clause grants one party the legal authority to access and utilize specific data, documents, or regulatory filings owned or controlled by another party. In practice, this often applies in contexts such as pharmaceutical development, where a licensee may need to reference a licensor’s regulatory submissions to support their own applications or approvals. This clause facilitates regulatory processes and collaboration by ensuring that necessary information can be shared and relied upon, thereby streamlining approvals and reducing duplication of effort.
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Right of Reference or Use. Merus hereby grants to Incyte, solely for the purposes set forth in this Agreement, a [**] relating to Licensed Antibodies or Licensed Products arising from Programs and existing as of the Execution Date or [**], and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Merus in order to effect such grant.
Right of Reference or Use. Each Party shall grant to the other Party a "Right of Reference or Use," as that term is defined in 21 C.F.R. Section 314.3(b), and any foreign equivalents, to any and all data and information relating to the Specified Studies or Licensed Products or Products, as the case may be, and necessary for such Party to submit a complete NDA for Licensed Products in the Territory in the case of ALPHARMA or outside the Territory in the case of IDEA, and each Party agrees to sign, and cause its Affiliates to sign, any instruments and take any actions reasonably requested by the other Party in order to effect such grant. Alternatively, at each Party's request, the other Party shall provide to the requesting Party complete copies of all documents, including without limitation pre-clinical and clinical databases (raw case report files and final study reports, pharmacology and toxicology reports, regulatory information, and such other information and data as is reasonably requested), documents related to pharmacology, toxicology, chemistry, manufacturing and controls, batch records, manufacturing information, analytical and quality control, as necessary for the requesting Party's submission of a complete NDA or foreign equivalent for any Licensed Product in the Territory in the case of ALPHARMA or outside the Territory in the case of IDEA.
Right of Reference or Use. Subject to the exclusive worldwide license with respect to Licensed Products granted to ▇▇▇▇▇▇ hereunder, ▇▇▇▇▇▇ hereby grants to ▇▇▇▇▇▇ a non-exclusive Right of Reference or Use to the ALTU-237 IND for purposes other than Licensed Products. ▇▇▇▇▇▇ agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by ▇▇▇▇▇▇ in order to further effect such grant.
Right of Reference or Use. Each Party hereby consents and grants to the other Party a Right of Reference or Use (without any further action required on the part of such other Party, whose authorization to file this consent with any Regulatory Authority is hereby granted) to any Regulatory Documentation and Regulatory Approvals (including all data contained or referenced therein) owned or Controlled by such Party that are described in Section 2.4.1 and 2.4.2 that are necessary for the Development, Manufacture or Commercialization (as set forth in this PD-1 License Agreement) of the Licensed Candidates, Licensed Products and Licensed Diagnostic Products.
Right of Reference or Use. Incyte hereby grants to Lilly, solely for the purposes set forth in this Agreement, a Right of Reference or Use to any and all Regulatory Documentation Controlled by Incyte relating to Licensed Products and existing as of the Effective Date or generated from any Clinical Trial commenced by Incyte prior to the Effective Date, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Lilly in order to effect such grant. Notwithstanding the foregoing, nothing in this Section 4.1 is intended to imply the existence of any particular data, information, drug master file or other Regulatory Documentation.
Right of Reference or Use. In the event of failure to assign any applicable Regulatory Documentation or Regulatory Approval to Celgene as required by Section 5.1, Vividion hereby consents and grants to Celgene a Right of Reference or Use (without any further action required on the part of Vividion, whose authorization to file this consent with any Regulatory Authority is hereby granted) to any such Regulatory Documentation or Regulatory Approval (including all data contained or referenced therein) that are necessary for the Development, Manufacture or Commercialization (as set forth in this Agreement) of the Licensed Products and Companion Diagnostics.
Right of Reference or Use. Incyte hereby grants to Novartis, solely for the purposes set forth in this Agreement, a Right of Reference or Use to any and all Regulatory Documentation Controlled by Incyte relating to Licensed Products and existing as of the Effective Date or generated from any Clinical Trial commenced by Incyte prior to the Effective Date, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Novartis in order to effect such grant. Notwithstanding the foregoing, nothing in this Section 4.1 is intended to imply the existence of any particular data, information, drug master file or other Regulatory Documentation.
Right of Reference or Use. Each Party, on behalf of itself and its Affiliates, hereby grants to the other Party and the other Party’s Affiliates, a Right of Reference or Use to all Data and Regulatory Documentation (including all Regulatory Approvals) related to the Product owned or Controlled by such Party or its Affiliates during the Term for all uses in connection with the Product for Development and Commercialization in the Field within the Territory.
Right of Reference or Use. Calithera hereby grants to Incyte, solely for the purposes set forth in this Agreement, a Right of Reference or Use to any and all Regulatory Documentation Controlled by Calithera relating to Licensed Compounds and Licensed Products and existing as of the Execution Date or generated from any Clinical Trial commenced by Calithera prior to the Execution Date with respect to the Licensed Compounds, and agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Incyte in order to effect such grant. Incyte hereby grants to Calithera, solely for the purpose of conducting Calithera Combination Studies that are not included within and conducted under the Development Plan, a Right of Reference or Use to any and all Regulatory Documentation Controlled by Incyte relating to Licensed Compounds and Licensed Products necessary or useful for the performance of such Calithera Combination Studies, and Incyte agrees to sign, and cause its Affiliates to sign, any instruments reasonably requested by Incyte in order to effect such grant.
Right of Reference or Use. CGEN hereby grants to Gilead a “Right of Reference or Use,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor regulation or analogous Applicable Laws and Regulations recognized outside of the United States), to all Regulatory Submissions (other than Assigned Regulatory Materials that have been assigned to Gilead) pertaining to the IL-18 Products in the Field submitted by or on behalf of CGEN or its Affiliates. Gilead and its Sublicensees may use such right of reference solely for the purpose of seeking, obtaining, supporting and maintaining Regulatory Approval and any Pricing and Reimbursement Approvals, as applicable, for any IL-18 Products in the Field in the Territory. CGEN will take such actions as may be reasonably requested by Gilead to give effect to the intent of this Section 6.2(c) (Right of Reference or Use), including, if requested by Gilead, (i) providing a signed statement that Gilead may rely on, and that the applicable Regulatory Authority may access, CGEN’s Regulatory Submissions in support of Gilead’s application for Regulatory Approval for any IL-18 Product, and (ii) providing Gilead with any underlying raw data or information submitted by CGEN to the Regulatory Authority with respect to any Regulatory Submissions Controlled by CGEN or any of its Affiliates that relates to any IL-18 Product.