Reference Rights Clause Samples

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Reference Rights. Each Party shall have the right, free of ---------------- charge, to refer to, access, cross reference, and use in their respective territories (i) information and Data provided by the other Party pursuant to Section 3.2.2 and generated by the other Party in the development and clinical testing of the Compound and the Product, and (ii) documents relating to the Product and the Finished Product filed by the other Party, its Affiliates or its Sublicensees with regulatory entities in their respective territories with respect to activities conducted in connection with development, approval and sale of the Product and the Finished Product, including, without limitation, the clinical studies and other supporting information, and any written communications to and with the FDA (or counterpart agency), provided that any out-of-pocket expenses incurred by the providing Party related to the provision of copies of such information, Data or documents required to the accessing Party shall be borne by the accessing Party. It is understood and agreed by the Parties that CTIT shall have the right, free of charge, to refer to, access, cross reference and use any such documents and information and Data prepared and/or filed by Chugai, its Affiliates, or its Sublicensees with respect to the Compound, the Product and/or the Finished Product. It is understood and agreed by the Parties that Chugai shall have the right, free of charge, to refer to, access, cross reference and use any such documents and information and Data prepared and/or filed by CTIT in any country outside of the Territory with respect to the Compound and/or the Product, and to receive a written right of reference for filing with regulatory authorities, to obtain regulatory approval of the Finished Product in the Territory.
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Reference Rights. Each party shall have the right, free of charge, to use any information and data provided by the other Party pursuant to Section 6.3, including, without limitation, data and information generated by the other Party or Party's Affiliates in the development and clinical testing of the Product as follows in this Section 6.
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Reference Rights. BSC and the Company shall each have reference rights to the other Party’s DMF filed at the FDA with respect to Products and Injection Catheters.
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Reference Rights. (a) Subject to Section 4.03(f), each Party hereby grants to the other Party (and their respective sublicensees or designees) a right of reference to Regulatory Filings owned or controlled by such Party as reasonably necessary to support the other Party’s Regulatory Filings made for the following purposes: (1) for MYLAN to Develop, manufacture and Commercialize Licensed Products in the Field in the Territory in accordance with this Agreement, including conducting any bridge programs to support a change in manufacturer and (2) for THERAVANCE to (w) Develop Licensed Products in the Field in the Territory in accordance with this Agreement, (x) file the initial NDA to Commercialize the first Licensed Products in the Field in the U.S. in accordance with this Agreement, (y) Commercialize Licensed Product in the Field in the U.S. under the Co-Promotion Agreement, and (z) Develop, manufacture and Commercialize Licensed ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Products (i) in the Field in China and the Reverted Countries and (ii) outside of the Field worldwide. Such rights of reference may include: i. the right for MYLAN to reference any and all drug master files (DMFs) referenced in the NDA for the Licensed Product in the Field in the Territory that is filed by THERAVANCE. THERAVANCE will enable right of reference to any and all such DMFs held by its contract manufacturer(s) which are relevant to Licensed Product to the extent that MYLAN elects to continue using such manufacturer for the Development or Commercialization of the Licensed Products in the Field in the Territory or as necessary to bridge to a new manufacturer. Such rights shall apply to DMFs relevant to API Compound and formulated Licensed Product, together with all updates to each of the foregoing; and ii. the right to reference any and all trial master files (TMFs) that are relevant to Licensed Products held by each Party or any of its contract research organization(s), together with all updates to each of the foregoing. (b) For clarity, the rights of reference set forth in Section 7.03(a)(2)(z) shall be subject to THERVANCE’s reimbursement obligations under Section 4.03(f)(ii), and all rights of reference set forth in Section 7.03(a)(2) shall be subject to the limitations set forth in Section 4.03(f)(iii). (c) Each Party granting a right of reference pursuant to this Section 7.03 s...
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Reference Rights. Each Party (the “Sponsoring Party”) hereby grants the other Party (the “Referencing Party”) a right of reference to all data and information contained or referenced in those sections of Regulatory Filings for the Sponsoring Party’s (and in the case of Schering, its Affiliates’) Products in the Territory (Licensed Products in the case of Schering, and Prescription Products bearing the Santarus Marks in the case of Santarus) that would be reasonably necessary for the Referencing Party’s Regulatory Filings concerning Licensed Products for Licensed Indications in the Field in the Territory (in the case of Schering as the Referencing Party) or Prescription Products bearing the Santarus Marks in the Territory (in the case of Santarus as the Referencing Party). The Sponsoring Party shall provide the applicable Regulatory Authority a letter confirming this right of reference at any time within fifteen (15) days of the Referencing Party’s request and shall take such other actions and execute such other documents as the Referencing Party may reasonably request to further confirm and give effect to this right of reference. Additionally, the Sponsoring Party agrees that the Referencing Party shall have the right, subject to JSC approval, to add to the Sponsoring Party’s applicable Regulatory Filing in the Territory protocols for clinical trials that may be required for Marketing Approval of (a) a Licensed Product for Licensed Indications in the Field by a Regulatory Authority in the Territory, in the case of Schering as the Referencing Party or (ii) a Prescription Product in the Territory, in the case of Santarus as the Referencing Party.
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Reference Rights. Cara (and its Affiliates and Sub-Licensees) shall have (i) the right of reference to the Enteris DMF and the information therein, and (ii) the right to reference the information contained in the Enteris DMF in all of Cara’s (and its Affiliates and Sub-Licensees) Regulatory Filings in jurisdictions where the Enteris DMF is not recognized, in each case solely for the purpose of exercising, using and practicing the licenses and other rights granted to Cara pursuant to this Agreement, provided that Cara shall bear any expenses (including expenses of Enteris) in respect of exercising any such right of reference.
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Reference Rights. Customer agrees to serve as a reference that will, upon ▇▇▇▇'s reasonable request, (i) provide comments related to this Agreement for distribution to third parties, and (ii) participate in Product related case studies. Snow shall have the right to issue a press release or other public statement concerning this Agreement and the relationship of the parties. Customer grants Snow the right to use Customer’s name and logo in Snow’s marketing communications and materials, subject to Customer’s published trademark guidelines and policies.
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Reference Rights. Following the Closing and in perpetuity the Purchaser shall permit the Seller to reference (and upon request shall so advise the FDA or other applicable regulatory authority), and upon Seller's request shall accord Seller access to, and copies of, all data contained in the Purchaser's Regulatory Approvals for the Royalty Bearing Products (as defined in the License Agreement) to the extent necessary to permit Seller to market and distribute the Royalty Bearing Products outside the Territory and to obtain and maintain Regulatory Approvals to market and distribute the Royalty Bearing Products outside the Territory. Purchaser shall promptly advise Seller of any changes made in any Royalty Bearing Product Regulatory Approval that could reasonably be expected to have an impact on such Regulatory Approvals of Seller outside the Territory.
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Related to Reference Rights

  • Relative Rights This Article 10 defines the relative rights of Holders of Notes and holders of Senior Debt. Nothing in this Indenture shall: (i) impair, as between the Company and Holders of Notes, the obligation of the Company, which is absolute and unconditional, to pay principal of and interest on the Notes in accordance with their terms; (ii) affect the relative rights of Holders of Notes and creditors of the Company other than their rights in relation to holders of Senior Debt; or (iii) prevent the Trustee or any Holder of Notes from exercising its available remedies upon a Default or Event of Default, subject to the rights of holders and owners of Senior Debt to receive distributions and payments otherwise payable to Holders of Notes. If the Company fails because of this Article 10 to pay principal of or interest on a Note on the due date, the failure is still a Default or Event of Default.

  • Cumulative Rights All agreements, warranties, guaranties, indemnities and other undertakings of Obligors under the Loan Documents are cumulative and not in derogation of each other. The rights and remedies of Agent and Lenders under the Loan Documents are cumulative, may be exercised at any time and from time to time, concurrently or in any order, and are not exclusive of any other rights or remedies available by agreement, by law, at equity or otherwise. All such rights and remedies shall continue in full force and effect until Full Payment of all Obligations.

  • Waiver; Cumulative Rights The failure or delay of either party to require performance by the other party of any provision hereof shall not affect its right to require performance of such provision unless and until such performance has been waived in writing. Each and every right hereunder is cumulative and may be exercised in part or in whole from time to time.

  • Cumulative Rights and No Waiver Each and every right granted to Bank under any Loan Document, or allowed it by law or equity shall be cumulative of each other and may be exercised in addition to any and all other rights of Bank, and no delay in exercising any right shall operate as a waiver thereof, nor shall any single or partial exercise by Bank of any right preclude any other or future exercise thereof or the exercise of any other right. Borrower expressly waives any presentment, demand, protest or other notice of any kind, including but not limited to notice of intent to accelerate and notice of acceleration. No notice to or demand on Borrower in any case shall, of itself, entitle Borrower to any other or future notice or demand in similar or other circumstances.

  • Cumulative Rights; No Waiver Duties and obligations imposed by this Agreement and rights and obligations hereunder are in addition to and not in lieu of any imposed by or available at law or in equity. No action or failure to act by District shall be deemed a waiver of any right or remedy afforded hereunder or acquiesce or approval of any breach or default of the Consultant.