Right of Reference and Use Sample Clauses

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Right of Reference and Use. Eidos hereby grants to Alexion (and any Affiliate or Sublicensee of Alexion) a right of reference to all Regulatory Documents pertaining to Licensed Products in the Field submitted by or on behalf of Eidos, its Affiliates or, subject to Section 2.8, Third Party Licensees, for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products in the Field in the Territory (or to seek any approvals from a Regulatory Authority required for the Development or Manufacturing of the Licensed Product in the ROW Territory in accordance with the scope of the license granted to Alexion in Section 2.1(b)). If requested by Alexion, Eidos will, and will cause its Affiliates and, subject to Section 2.8, Third Party Licensees, to provide a signed statement to this effect in accordance with Applicable Laws. Alexion hereby grants to Eidos (and any Affiliate or Third Party Licensee of Eidos) a right of reference to all Regulatory Documents pertaining to Licensed Products submitted by or on behalf of Alexion, its Affiliates or, subject to Section 2.2(b), Sublicensees, for the purpose of seeking, obtaining and maintaining Regulatory Approval as applicable, of Licensed Products in the ROW Territory (or to seek any approvals from a Regulatory Authority required for the Development or Manufacturing of the Licensed Product in the Territory in accordance with Eidos’ retained rights). If requested by Eidos, Alexion will, and will cause its Affiliates and, subject to Section 2.2(b), its Sublicensees, to provide a signed statement to this effect in accordance with Applicable Laws.
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Right of Reference and Use. Immunomedics hereby grants to Licensee a right of reference to all Existing Development Data and New Immunomedics Development Data solely for the purposes of performing Development Activities pursuant to this Agreement. Licensee may only use the Existing Development Data and New Immunomedics Development Data for the purpose of Developing the Product for sale in the Field in the Territory pursuant to this Agreement, provided however, that Immunomedics only grants Licensee a right of reference to Existing Development Data and New Immunomedics Development Data and generated by Immunomedics from the *** only to the extent the foregoing is related to, with respect to Phase 2 Clinical Trials or Phase 3 Clinical Trials, safety, and in addition with respect to ***, *** and *** in each case of the Product in the Oncology Field. For clarity, ***. Licensee hereby grants to Immunomedics a right of reference to all New Licensee Development Data for purposes of (i) *** under this Agreement, and (ii) *** *** and (iii) *** in any other *** or *** by or on *** or its licensee ***.
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Right of Reference and Use. The Parties will conduct a joint multi-regional Phase II Clinical Trial in the China Market and the Opt-In Territory with respect to Licensed Products for the indication of bladder cancer (the “MRCT”). Without any additional consideration to Licensor, Licensor will grant to Licensee, its Affiliates, and its Sublicensees a Right of Reference and Use, as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, under any and all Regulatory Materials of Licensor or its Affiliates in the Opt-In Territory to the extent necessary or reasonably useful for Licensee to Develop, Manufacture, or Commercialize Licensed Products in the Field in the Territory. Without any additional consideration to Licensee, Licensee will grant to Licensor, its Affiliates, and its sublicensees a Right of Reference and Use, as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, under any and all Regulatory Materials of Licensee and its Affiliates in the Territory to the extent necessary or reasonably useful for Licensor to Develop, Manufacture, or Commercialize Licensed Products in the Field in the Opt-In Territory. To the extent that Parties mutually agree that it is not practical to conduct the MRCT, the Parties will conduct relevant Phase II Clinical Trials separately in the relevant jurisdiction.
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Right of Reference and Use. 2.5.1 Without limiting any other disclosure obligations under this Agreement, each Party shall, upon request, disclose to the other Party all pre-clinical, non-clinical, clinical data (including clinical and other applicable reports and, upon request, raw data) and Regulatory Documentation Controlled by a Party or its Affiliates and generated from or arising out of its Development activities that are included within the Collaboration Activities (the “Developed Regulatory Documentation”). Notwithstanding the foregoing, any data that is or is of the type that would be included in any Drug Master File (e.g., chemistry, manufacturing and controls data) shall be required to be disclosed only (a) to the extent reasonably necessary for the receiving Party to support or maintain an IND anywhere in the world to Develop the Licensed Products as contemplated hereunder or application for Regulatory Approval or Pricing Approval in its territory or (b) pursuant to a separate provision under this Agreement or any supply or quality agreement agreed between the Parties or their respective Affiliates. For clarity, such Developed Regulatory Documentation shall be Confidential Information of the applicable disclosing Party, and may be used by the receiving Party only as expressly licensed under this Agreement. For clarity, Mersana shall not reference or otherwise use clinical data or Licensee Regulatory Documentation generated in connection with any Independent Development of Licensee unless and until Mersana [***], and Licensee shall not reference or otherwise use clinical data or Mersana Regulatory Documentation generated in connection with any Independent Development of Mersana unless and until Licensee [***]. 2.5.2 Subject to Section 2.5.4, each Party shall have the right to use Developed Regulatory Documentation in order to Develop Licensed Products, obtain or maintain Regulatory Approval for and Commercialize Licensed Products in the Field to the extent licensed under Section 2.1 or Section 2.3, as applicable, either exclusively or non-exclusively, as set forth in such section in accordance with the terms of this Agreement. 2.5.3 Subject to Section 2.5.4, each Party hereby grants to the other Party a Right of Reference or Use to any and all such Developed Regulatory Documentation Controlled by such Party to Develop Licensed Products and obtain or maintain Regulatory Approval and Pricing Approval for Licensed Products to the extent licensed under Section 2.1 or Section 2...
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Right of Reference and Use. Subject to the terms of Sections 2.3, 2.4, 2.5 and 2.6, [***] for the purposes of performing Development Activities and Commercialization activities pursuant to this Agreement. Subject to the terms of Sections 2.3, 2.4, and 2.6, [***]. Brickell may further [***].
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Right of Reference and Use. Each Party hereby grants to the other Party, and, subject to the remainder of this Section 5.3, such other Party’s Affiliates, Sublicensees (in the case of G1 as the granting Party) or Third Party Licensees (in the case of Licensee as the granting Party) the right of reference to all Regulatory Documents pertaining to the Licensed Compound or Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates; provided that a Party’s right of reference to the other Party’s Regulatory Documents shall be (a) limited to Regulatory Documents Controlled by such other Party or its Affiliates, and (b) solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of the Licensed Products (i) in the case of Licensee, in the Field in the Territory and (ii) in the case of G1, outside the Territory. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 5.3. Notwithstanding the foregoing, the right of reference granted by Licensee to G1 under this Section 5.3 shall extend to, and may be practiced by G1, its Affiliates, and its Third Party Licensees to the extent that G1 has, on Licensee’s behalf, obtained from the applicable Affiliate or Third Party Licensee the right of reference to all Regulatory Documents pertaining to the Licensed Compound or Licensed Products submitted by or on behalf of such Affiliate or Third Party Licensee and the right for Licensee and such Affiliate or Sublicensee to practice and authorize the practice of such right of reference.
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Right of Reference and Use. Each Party hereby grants to the other Party the right of reference to all Regulatory Documents pertaining to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates provided that Licensee’s right of reference to Verastem’s Regulatory Documents shall be (i) subject to Section 5.3(b) and (ii) limited to Regulatory Documents Controlled by Verastem or its Affiliates, and (iii) 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. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section ‎5.3.
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Right of Reference and Use. 4.4.1. Licensee hereby grants to Licensor a right of reference during the Term to all Regulatory Documents pertaining to the Licensed Compound and any Licensed Product submitted to the Regulatory Authorities in the Territory by or on behalf of Licensee, its Affiliates or Permitted Sublicensees and any Product Data made available to Licensor by Licensee pursuant to Section 4.5, for the purpose of seeking, obtaining and maintaining the Regulatory Approvals of any Licensed Product outside the Territory. If requested by Licensor, Licensee shall, and shall cause its Affiliates or Permitted Sublicensees, to provide a signed statement to this effect in accordance with the Applicable Laws. 4.4.2. Licensor hereby grants to Licensee a right of reference during the Term to all Regulatory Documents pertaining to the Licensed Compound and Licensed Product in the Field submitted to the Regulatory Authorities outside the Territory by or on behalf of Licensor or its Affiliates and any Product Data made available to Licensee by Licensor pursuant to Section 4.5, for the purpose of seeking, obtaining and maintaining the Regulatory Approvals of the Licensed Product in the Field in the Territory. If requested by Licensee, Licensor will, or will cause its Affiliates to, provide a signed statement to this effect in accordance with the Applicable Laws.
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Right of Reference and Use. Each Party hereby grants to the other Party a right of reference to all Regulatory Documents pertaining to any Licensed Product (including any New Formulation Product) in the Field submitted by or on behalf of such Party or its Affiliates provided that (a) each Party's right of reference to the other Party’s Regulatory Documents shall be limited to Regulatory Documents Controlled by such other Party or its Affiliates, (b) Licensee’s right of reference to Verastem’s Regulatory Documents shall be 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, and (c) Verastem’s right of reference to Licensee’s Regulatory Documents shall be 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 outside of the Territory. Each Party shall bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 5.3.
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Related to Right of Reference and Use

  • Right of Reference Section 1: If the two Parties fail to agree upon an interpretation of the Agreement, either Party shall have the right to refer the matter to the Joint Industry Committee, hereinafter provided, and if either party does make such reference, the other Party must accept the reference. Section 2: The Joint Industry Committee shall consist of three (3) representatives selected by the USW. Negotiating Committee and three (3) representatives selected by the Employers represented in the negotiations of this Agreement, and the two (2) committees may be represented by one (1) or more Parties selected by them. Section 3: When an interpretation of the Agreement has been referred to the Joint Committee, this reference shall be for the period of forty-eight (48) hours or longer by mutual consent of the Parties to this Agreement. In case the Joint Committee agrees upon a recommendation or interpretation, this shall be furnished in writing to the Union involved and to the Employer. Section 4: In the event the Joint Committee members disagree, all the facts in the case as found by the Union and Union members of the Joint Committee shall be placed in writing by the Union representatives and submitted to the Employer and to the Union Members involved. The facts in the case as found by the Employer and the employer members of the Joint Committee shall be placed in writing and given to the Union member employees for their information. Section 5: If a satisfactory interpretation of the point in question is not reached, either Party may refer the question to arbitration as hereinafter provided.

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • Right of Reimbursement Each Revolving Credit Lender agrees to reimburse the Issuing Lender on demand, pro rata in accordance with its respective Revolving Credit Percentage, for (i) the reasonable out-of-pocket costs and expenses of the Issuing Lender to be reimbursed by the Borrower pursuant to any Letter of Credit Agreement or any Letter of Credit, to the extent not reimbursed by the Borrower or any other Credit Party and (ii) any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, fees, reasonable out-of-pocket expenses or disbursements of any kind and nature whatsoever which may be imposed on, incurred by or asserted against Issuing Lender in any way relating to or arising out of this Agreement (including Section 3.6(c) hereof), any Letter of Credit, any documentation or any transaction relating thereto, or any Letter of Credit Agreement, to the extent not reimbursed by the Borrower, except to the extent that such liabilities, losses, costs or expenses were incurred by Issuing Lender as a result of Issuing Lender’s gross negligence or willful misconduct or by the Issuing Lender’s wrongful dishonor of any Letter of Credit after the presentation to it by the beneficiary thereunder of a draft or other demand for payment and other documentation strictly complying with the terms and conditions of such Letter of Credit.

  • Installation and Use Rights You may install and use any number of copies of the software on your devices.

  • Right of Use 8.1 Unless otherwise stated in Appendix 7, the Customer may only use the released material for his own purposes and only to the extent that it is necessary to maintain and further develop the program’s functions as it can be considered guaranteed and assumed in the protected agreement, cf. Appendix 2.