Rights of Reference definition

Rights of Reference means rights of reference, as contemplated under, inter alia, 21 CFR §314.50, to the Product NDA.
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Rights of Reference means: (a) in the U.S., a “right of reference or use,” as such term is defined in 21 C.F.R. 314.3(b); or (b) in any other country or jurisdiction, the equivalent authority to rely upon, and otherwise use, an investigation for the purpose of filing, and conducting a clinical trial under, an IND, or obtaining Marketing Approval or other Regulatory Approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority in such country or other jurisdiction, if necessary.
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Rights of Reference means, with regard to a Party, a grant of rights (including through a Third Party) that allows the applicable Regulatory Authority in a country to have access to relevant information (by cross‐reference, incorporation by reference or otherwise) contained in a Regulatory Dossier (and any data contained therein) filed with another Regulatory Authority by or on behalf of the other Party (its Affiliate or sublicensee).
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Examples of Rights of Reference in a sentence

  • Upon the expiration of the Royalty Term for a given Licensed Product in a given Region in the Territory, the licenses and rights of reference granted to Lian pursuant to Section 2.1 (License Grants; Rights of Reference) will become perpetual, irrevocable, fully paid-up, royalty free, fully sublicensable, and transferable with respect to such Licensed Product in such Region.

  • The Party granting the right of reference under this Section 7.4 (Rights of Reference; Further Assurances) will execute and deliver, or will cause to be executed and delivered, to the non-granting Party such endorsements, assignments, and other documents as may be reasonably necessary to effect the foregoing right to reference.

  • Effective only as of the NDA Transfer Date, Depomed shall, and it hereby does, assign to Santarus all right, title and interest in the Product NDA, subject to the Existing Rights of Reference and any Additional Rights of Reference granted by Depomed during the Pre-Transfer Period, and the Product IND.

  • Depomed has provided to Santarus all excerpts from the Existing Rights of Reference Agreements that contain provisions with respect to the Existing Rights of Reference or the right of access to data described in Section 3.4, and all such excerpts are true and accurate.

  • As of the effective date of such termination, (a) all licenses and Rights of Reference granted by BioNTech hereunder shall immediately terminate other than the license set forth in Section 9.1.2, and (b) all licenses and Rights of Reference granted by Genentech hereunder shall immediately terminate other than the license set forth in Section 9.2.2; except to the extent reasonably necessary for the licensee Party to fulfill its post-termination obligations under this Section 14.5.

  • Licensor shall provide to Licensee copies of all Gestiva IND submissions and correspondence, all Gestiva NDA submissions and correspondence and all Gestiva Orphan Drug Designation correspondence (collectively, the “Post-Approval Regulatory Documentation”) occurring after the Effective Date and until the termination of the Rights of Reference as provided in Section 4.3. The Post-Approval Regulatory Documentation shall be provided by Licensor to Licensee on a reasonably current basis.

  • Sanofi shall have the right to grant (i) sublicenses (or further Rights of Reference), through multiple tiers of sublicensees, under the licenses and Rights of Reference granted in Section ‎6.1.1 (Grant), or (ii) licenses under the Sanofi Technology and Rights of Reference Controlled by Sanofi, in each case, to its Affiliates and other Persons; provided that any such sublicenses (and further Right of Reference) shall be [***].

  • Any information of a Party to which the other Party obtains access pursuant to this Section 5.4 (Rights of Reference) shall, subject to Sections 10.1 (Duty of Confidence) and 10.2 (Exceptions), be deemed the Confidential Information of such first Party.

  • Denali shall have the right to grant sublicenses (or further Rights of Reference) under the licenses and Rights of Reference granted to Denali under Section ‎6.2.1 (Grant) to its Affiliates and other Persons; provided that any such sublicenses (and further right of reference) shall be [***].

  • Licensee will not exercise, license, sublicense or otherwise transfer its Rights of Reference prior to the Retransfer Date, nor subsequent to the expiration of the Term.

Related to Rights of Reference

  • Terms of Reference (TOR) means the document included in the RFP as Section 5 which explains the objectives, scope of work, activities, tasks to be performed, respective responsibilities of the Client and the Consultant, and expected results and deliverables of the assignment.

  • Right of Reference means a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any comparable right existing under the laws or regulations of any foreign country.

  • the book of reference means the book of reference certified by the Secretary of State as the book of reference for the purposes of this Order;

  • Terms of Reference (TORs) means the Terms of Reference that explains the objectives, scope of work, activities, and tasks to be performed, respective responsibilities of the Procuring Entity and the Consultant, and expected results and deliverables of the assignment.

  • Terms of Reference (TOR) means the document included in the RFP as Section 5 which explains the objectives, scope of work, activities, tasks to be performed, respective responsibilities of the Client and the Consultant, and expected results and deliverables of the Assignment/job.

  • Cross-reference The statutory provisions on the President and the Executive are found in title 2 of this code. The statutory provisions on the FSM Congress are found in title 3 of this code.

  • unit of Reference Property shall have the meaning specified in Section 14.07(a).

  • Performance References has the meaning set forth for such term in the definition of Derivative Instrument.

  • Underlying Reference means as set out in §25(a) below.

  • Other Definitional Provisions set forth in Section 1.2 of the Basic Servicing Agreement are incorporated by reference into this 2017-3 Servicing Supplement.

  • Underlying Referencek means the Basket of Shares as set out in item 31(a)

  • Terms Incorporated by Reference means the Non-Cleared Swap Agreement(s) governing the Trade memorialized in the Trade Communication.

  • Miscellaneous Interests means the entire interest of the Vendor in and to all property, assets and rights, other than the Petroleum and Natural Gas Rights and the Tangibles, to the extent such property, assets and rights pertain to the Petroleum and Natural Gas Rights or the Tangibles, or any rights relating thereto, including, without limitation of the generality of the foregoing, the entire interest of the Vendor in:

  • Certain Defined Terms As used in this Agreement, the term "Prospectus" means the applicable Portfolio's prospectus and related statement of additional information, whether in paper format or electronic format, included in the Portfolio's then currently effective registration statement (or post-effective amendment thereto), and any information that we or the Portfolio may issue to you as a supplement to such prospectus or statement of additional information (a "sticker"), all as filed with the Securities and Exchange Commission (the "SEC") pursuant to the Securities Act of 1933. 2.

  • Miscellaneous unit means a hazardous waste management unit where hazardous waste is treated, stored, or disposed of and that is not a container, tank, surface impoundment, pile, land treatment unit, landfill, incinerator, boiler, industrial furnace, underground injection well with appropriate technical standards under 40 CFR Part 146, containment building, corrective action management unit, or unit eligible for a research, development, and demonstration permit under § 270.65, or staging pile.

  • Access Code means the Railways (Access) Code 2000;

  • angle of repose means the steepest angle of a surface at which a mass of loose or fragmented material will remain stationary in a pile on the surface, rather than sliding or crumbling away;

  • Nodal Reference Price at each location shall mean the 97th percentile price differential between day-ahead and real-time prices experienced over the corresponding two-month reference period in the prior calendar year. Reference periods will be Jan-Feb, Mar-Apr, May- Jun, Jul-Aug, Sept-Oct, Nov-Dec. For any given current-year month, the reference period months will be the set of two months in the prior calendar year that include the month corresponding to the current month. For example, July and August 2003 would each use July- August 2002 as their reference period. No-load Cost:

  • Other Secured Claims means any Secured Claim against the Debtors that is not an Administrative

  • Original Reference Rate means the originally-specified benchmark or screen rate (as applicable) used to determine the Rate of Interest (or any component part thereof) on the Notes.

  • Adjustment Provisions means all relevant provisions of these Conditions which provide for any adjustment, delay, modification, cancellation or determination in relation to an Index, the valuation procedure for an Index or the Preference Shares. This shall include the provisions of Condition 11 (Calculation Agent Modifications) and all subsequent Conditions.

  • General Unsecured Claims means Claims against any Debtor that are not Secured Claims, Administrative Claims, Priority Claims, Professional Compensation Claims, Intercompany Claims, or Equity Interests.

  • AND TO The registrar and transfer agent for the securities of Response Biomedical Corp. The undersigned (A) acknowledges that the sale of the securities of Response Biomedical Corp. (the “Company”) [represented by certificate number/described in the direct registration system advice with holder account number] ___________________, to which this declaration relates was made in reliance on Rule 904 of Regulation S under the United States Securities Act of 1933, as the same has been, and hereafter from time to time, may be amended (the “U.S. Securities Act”) and (B) certifies that (1) the undersigned is not an “affiliate” of the Company as that term is defined in Rule 405 under the U.S. Securities Act, a “distributor” or an affiliate of “distributor”, (2) the offer of such securities was not made to a person in the United States and either (a) at the time the buy order was originated, the buyer was outside the United States, or the seller and any person acting on its behalf reasonably believed that the buyer was outside the United States or (b) the transaction was executed on or through the facilities of a “designated offshore securities market” (as defined in Rule 902 of Regulation S under the U.S. Securities Act) and neither the seller nor any person acting on its behalf knows that the transaction has been prearranged with a buyer in the United States, (3) neither the seller nor any affiliate of the seller nor any person acting on their behalf has engaged or will engage in any “directed selling efforts” in the United States in connection with the offer and sale of such securities, (4) the sale is bona fide and not for the purpose of “washing-off” the resale restrictions imposed because the securities are “restricted securities” as that term is described in Rule 144(a)(3) under the U.S. Securities Act, (5) the seller does not intend to replace such securities sold in reliance on Rule 904 of the U.S. Securities Act with fungible unrestricted securities, and (6) the contemplated sale is not a transaction, or part of a series of transactions, which, although in technical compliance with Regulation S under the U.S. Securities Act, is part of a plan or scheme to evade the registration provisions of the U.S. Securities Act. Unless otherwise specified, terms set forth above in quotation marks have the meanings given to them by Regulation S under the U.S. Securities Act. DATED at __________ this ___ day of __________, 20__. By: Name: Title: AFFIRMATION BY SELLER’S BROKER-DEALER (REQUIRED FOR SALES IN ACCORDANCE WITH SECTION (B)(2)(B) ABOVE) We have read the foregoing representations of our customer, _________________________ (the “Seller”) dated _______________________, with regard to our sale, for such Seller’s account, of the securities of the Company described therein, and on behalf of ourselves we certify and affirm that (A) we have no knowledge that the transaction had been prearranged with a buyer in the United States, (B) the transaction was executed on or through the facilities of a “designated offshore securities market” (as defined in Rule 902 of Regulation S under the U.S. Securities Act); (C) neither we, nor any person acting on our behalf, engaged in any directed selling efforts in connection with the offer and sale of such securities, and (D) no selling concession, fee or other remuneration is being paid to us in connection with this offer and sale other than the usual and customary broker’s commission that would be received by a person executing such transaction as agent. Terms used herein have the meanings given to them by Regulation S under the U.S. Securities Act. Name of Firm By: Date: Authorized officer

  • Original Rights shall have the meaning set forth in Section 1(f)(i) hereof.

  • Ladies and Gentlemen For value received, the undersigned beneficiary hereby irrevocably transfers to: ------------------------------ [Name of Transferee] ------------------------------ [Address of Transferee] all rights and obligations of the undersigned as Borrower under the Liquidity Agreement referred to above. The transferee has succeeded the undersigned as Subordination Agent under the Intercreditor Agreement referred to in the first paragraph of the Liquidity Agreement, pursuant to the terms of Section 8.1 of the Intercreditor Agreement. By this transfer, all rights of the undersigned as Borrower under the Liquidity Agreement are transferred to the transferee and the transferee shall hereafter have the sole rights and obligations as Borrower thereunder. The undersigned shall pay any costs and expenses of such transfer, including, but not limited to, transfer taxes or governmental charges. We ask that this transfer be effective as of _______________, ____. WILMINGTON TRUST COMPANY, not in its individual capacity but solely as Subordination Agent, as Borrower By:_____________________________________ Name: Title:

  • Documents Incorporated by Reference means all financial statements, management’s discussion and analysis, management information circulars, annual information forms, material change reports or other documents issued by the Corporation, whether before or after the date of this Agreement, that are required by NI 44-101 to be incorporated by reference into the Prospectus or any Prospectus Amendment;