Right of Reference Clause Samples
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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.
Right of Reference. Company shall have the right to reference the DMF solely in connection Company’s regulatory filings submitted in connection with obtaining Marketing Approval for the Licensed Product.
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 Related Parties, 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, 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 Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional 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) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). 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 the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses...
Right of Reference. (i) Acutus, to the extent it is an Approval Holder for the FS Product Line, shall permit the BIO Parties access to, and grants the BIO Parties the right to reference Acutus’ Regulatory Filings for the FS Product Line for the purpose of enabling the BIO Parties to obtain and maintain Marketing Authorization Approval for any product within the FS Product Line in any country in the Territory outside of the US or the EU and for the External Products, at no cost to the BIO Parties. In furtherance of the foregoing, Acutus, as the Approval Holder for such FS Product Line, shall promptly upon request of the BIO Parties, deliver a letter to the FDA (or the Notified Body or other applicable Regulatory Authority in any other country in the Territory) authorizing the BIO Parties to reference and use the such Regulatory Filings in support of the BIO Parties’ efforts to seek Marketing Authorization Approval for any product within the FS Product Line in any country in the Territory outside the US or the EU or the External Products.
(ii) The BIO Parties, to the extent it is an Approval Holder for the FS Product Line or the External Products, grants Acutus the right to reference all Regulatory Filings for such FS Product Line and External Products for the purpose of enabling Acutus to obtain and maintain Marketing Authorization Approval for any product within the FS Product Line in any country in the Territory, at no cost to Acutus. In furtherance of the foregoing, the BIO Parties, to the extent it is the Approval Holder for the FS Product Line or the External Products, shall promptly upon the request of Acutus, deliver a letter to the FDA (or the Notified Body or other applicable Regulatory Authority in any other country in the Territory) authorizing Acutus to reference such Regulatory Filings in support of Acutus’ efforts to seek Marketing Authorization Approval for any product within the FS Product Line in any country in the Territory.
(iii) With respect to the foregoing subclauses (b)(i) and (b)(ii), to the extent any such right of reference is not available, the Parties shall cooperate in good faith to provide the requesting Party with the similar ability to obtain such Marketing Authorization Approval on the basis of such Party that is the Approval Holder’s Regulatory Filings, which may include such Party that is the Approval Holder providing the information included in such Party’s Regulatory Filings directly to the applicable Regulatory Authority for the benefit of...
Right of Reference. The Licensor hereby grants to Alzheon and its Affiliates and sublicensees an exclusive Right of Reference to, and a royalty-bearing, irrevocable (except as set forth herein), exclusive (even as to the Licensor) license or sublicense (as applicable) to access and use, the Licensed Data (and any regulatory submissions, clinical dossiers and regulatory approvals that include such Licensed Data) for any and all purposes, other than developing, commercializing and/or seeking regulatory approval for the Vivimind Product in the Vivimind Field. The Licensor shall, at Alzheon’s request, provide a signed statement in accordance with 21 C.F.R. 314.50(g)(3) (or any analogous Law outside the United States), or otherwise provide appropriate notification of such right to the applicable Regulatory Authority, to the extent necessary for Alzheon and its Affiliates and sublicensees to exercise the Right of Reference granted hereunder.
Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party. Zai may use such right of reference to Paratek’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Licensed Products in Field in the Territory. Paratek may use the right of reference to Zai’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining regulatory approval of the Licensed Products outside the Territory.
Right of Reference. Each Party hereby grants to the other a “right of reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data controlled by such Party that relates to any Product, and 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).
Right of Reference. CytomX hereby grants to Pfizer a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data Controlled by CytomX or its Affiliates (a) to the extent that it specifically pertains to a Probody contained in the Agreement PDCs, the Licensed Products or preclinical studies with respect to the Licensed Products and (b) that Pfizer reasonably believes may be necessary or useful to the Development, Manufacturing or Commercialization of any Agreement PDC or any Licensed Product pursuant to this Agreement, and CytomX will provide a signed statement to the foregoing effect, if so requested by Pfizer in accordance with 21 C.F.R. § 314.50(g)(3).
Right of Reference. Surface hereby grants to Novartis, and at the request of Novartis will grant to Novartis’s Related Parties, 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, 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 Studies or early access/named patient programs for the T1 Licensed Products) included in or used in support of any drug master file maintained by or on behalf of Surface (including its Related Parties) that relates to any T1 Licensed Product to the extent necessary or useful to Research, Develop, Manufacture or Commercialize T1 Licensed Products in the Novartis Territory. Notwithstanding anything to the contrary in this Agreement, Surface will not withdraw or inactivate any regulatory filing that Novartis or its Related Parties reference or otherwise use pursuant to this Section 7.1.3.
Right of Reference. Trubion hereby grants to Wyeth a "Right of Reference," as that term is defined in 21 C.F.R. Section 314.3(b), to any data Controlled by Trubion that relates to any CD20 Product (and any other Licensed Product, to the extent applicable), and Trubion shall provide a signed statement to this effect, if requested by Wyeth, in accordance with 21 C.F.R. Section 314.50(g)(3).