Registration Enabling Trial definition

Registration Enabling Trial means any Clinical Trial that is intended to, or does, generate data sufficient to enable the Filing of a Marketing Application in any country in the Territory. For clarity, a Registration-Enabling Trial may be a Phase 1 Trial, a Phase 2 Trial, or a Phase 3 Trial; provided, however, for any Clinical Trial other than a Phase 3 Trial, the determination of whether such Clinical Trial is a Registration-Enabling Trial shall be solely determined by the Filing of a Marketing Application for such Licensed Product after completion of such Clinical Trial.
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Registration Enabling Trial means a Clinical Trial for DB-OTO (a) the results of which, together with other data and information concerning such product, are intended to or do establish that such product is safe and effective for its intended use; (b) that forms the primary basis (alone or with one or more additional Registration Enabling Trials) of an effectiveness claim in support of a Marketing Approval for such product; and (c) that (i) meets the criteria for a Phase III Clinical Trial (or the equivalent under the rules of the EMA, the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) or the applicable national Regulatory Authority in any of Germany, France, Italy or Spain (the FDA, the EMA, the MHRA, and such other Regulatory Authorities, collectively, the “Specified Regulatory Authorities”)) at the time such Clinical Trial is Initiated or (ii) is acknowledged in writing by any of the Specified Regulatory Authorities to satisfy clauses (a) and (b).
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Registration Enabling Trial means a clinical trial for DB-OTO (a) the results of which, together with other data and information concerning such product, are intended to or do establish that such product is safe and effective for its intended use; (b) that forms the primary basis (alone or with one or more additional Registration Enabling Trials) of an effectiveness claim in support of a Marketing Approval (as defined in the CVR Agreement) for such product; and (c) that (i) meets the criteria for a Phase III clinical trial (or the equivalent under the rules of the EMA, the MHRA or the applicable national regulatory authority in any of Germany, France, Italy or Spain (the FDA, the EMA, the MHRA, and such other regulatory authorities, collectively, the “Specified Regulatory Authorities”)) at the time such clinical trial is Initiated or (ii) is acknowledged in writing by any of the Specified Regulatory Authorities to satisfy clauses (a) and (b).
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Examples of Registration Enabling Trial in a sentence

  • In addition, subject to the terms and conditions of this Agreement, following the achievement of both of the Initial Registration Enabling Trial Milestone Events, the Parties shall use Commercially Reasonable Efforts to Develop one (1) Licensed Product for the treatment of one (1) Additional Indication in the United States.


More Definitions of Registration Enabling Trial

Registration Enabling Trial means a Clinical Trial of a Collaboration Product that is designed to, and for which a competent Regulatory Authority in the Territory has provided guidance that the design of such Clinical Trial is sufficient to, ascertain efficacy and safety of such Collaboration Product in support of the preparation and submission of Regulator Approval for Commercialization of such Collaboration Product to such competent Regulatory Authority, regardless of whether such Clinical Trial is referred to as a Phase 2, Phase 2b or Phase 3 Clinical Trial or otherwise, provided that for countries where Regulatory Authorities will not make this determination or provide this guidance ahead of a Clinical Trial, the Parties shall jointly agree in the R&D Plan when / which Clinical Trial shall for that country constitute a Registration Enabling Trial and such Clinical Trial shall comprise a Registration Enabling Trial for the purposes of this Agreement. If a Clinical Trial of a Collaboration Product is not initially designed as a Registration Enabling Trial but is later re-designed, converted or expanded into such a trial, then it shall be deemed to be a Registration Enabling Trial as of the date of such re-design, conversion or expansion. If the Sponsor or, if different, the Party responsible for regulatory filing and communication publicly describes (including in public announcements or information on its website) a Clinical Trial of a Collaboration Product that has not otherwise been classified as a Registration Enabling Trial pursuant to this Section as such a trial or a Phase 3 Trial, then such Clinical Trial shall be deemed to be a Registration Enabling Trial as of the first date that such description is available to the public.
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Registration Enabling Trial. , means, with respect to a Licensed Product, a human clinical study (whether or not designated a Phase 3 Clinical Study), the results of which, together with prior data and information concerning such Licensed Product, [***] of an effectiveness claim in support of the initial approval of an NDA for such intended use of such Licensed Product. A Registration Enabling Trial includes a Phase 3 Clinical Study. If a human clinical study is denominated not a Phase 3 Clinical Study (for example, human clinical studies formally registered as Phase 2 clinical studies) then it shall only be treated as a Registration Enabling Trial hereunder if and when [***].
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Registration Enabling Trial means, with respect to a Licensed Product, a human clinical study (whether or not designated a Phase 3 Clinical Study), the results of which, together with prior data and information concerning such Licensed Product, [***] of an effectiveness claim in support of the initial approval of an NDA for such intended use of such Licensed Product. A Registration Enabling Trial includes a Phase 3 Clinical Study. If a human clinical study is denominated not a Phase 3 Clinical Study (for example, human clinical studies formally registered as Phase 2 clinical studies) then it shall only be treated as a Registration Enabling Trial hereunder if and when [***].
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Registration Enabling Trial means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field in a given country in the Territory, a Clinical Trial for such Licensed Product for which the applicable Regulatory Authority in such country has provided guidance that the design of such Clinical Trial and results of such Clinical Trial, together with prior data and information concerning such Licensed Product, (a) are sufficient to establish that such Licensed Product is safe and effective for its intended use, and (b) forms the primary basis (alone or with one (1) or more additional Registration Enabling Trials) of an effectiveness claim in support of Regulatory Approval for such Licensed Product, regardless of whether such Clinical Trial is referred to as a Xxxxx 0, Xxxxx 2b or Phase 3 clinical trial. If a Clinical Trial of a Licensed Product does not meet the definition of a Registration Enabling Trial as of the date it is Initiated but later meets the definition of a Registration Enabling Trial, then for the purposes of Section 8.2, such Clinical Trial shall be deemed to be a Registration Enabling Trial as of the date the applicable Regulatory Authority accepts the submission of the BLA in which such Clinical Trial forms the primary basis of an effectiveness claim in support of Regulatory Approval for such Licensed Product.
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Related to Registration Enabling Trial

  • Registration decal means an adhesive sticker produced by the department and issued by the

  • Registration Filing Date means the date that is 60 days after date of the final closing of the PPO.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Registration Data means certain personal and financial information that you are required to provide in order to complete the Account Opening Application Form and become our Client, such information can include without limitation a copy of your passport, driving license and/or Photo identity card.

  • Registration Form means a book voter registration form and a by-mail voter

  • Registration Books means the records maintained by the Trustee pursuant to Section 2.08 for the registration and transfer of ownership of the Bonds.

  • Registration Period shall have the meaning specified in Section 5(C), below.

  • Original Registration Statement. As used in this Agreement, the terms “amendment” or “supplement” when applied to the Registration Statement or the Prospectus shall be deemed to include the filing by the Company with the Commission of any document under the Exchange Act after the date hereof that is or is deemed to be incorporated therein by reference. All references in this Agreement to financial statements and schedules and other information which is “contained,” “included” or “stated” in the Registration Statement or the Prospectus (and all other references of like import) shall be deemed to mean and include all such financial statements and schedules and other information which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date; and all references in this Agreement to amendments or supplements to the Registration Statement or the Prospectus shall be deemed to mean and include, without limitation, the filing of any document under the Exchange Act which is or is deemed to be incorporated by reference in or otherwise deemed under the Securities Act to be a part of or included in the Registration Statement or the Prospectus, as the case may be, as of any specified date. At the time the Registration Statement was or will be originally declared effective and at the time the Company’s most recent annual report on Form 10-K was filed with the Commission, if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act.

  • Registration Event means the occurrence of any of the following events:

  • Provisional registration means a building official, plan reviewer, or inspector who is registered subject to his or her completion of the amount of training, education, and experience required by the commission and the appropriate advisory board and described in section 1007(2).

  • Additional Registration Statement means a registration statement or registration statements of the Company filed under the 1933 Act covering any Additional Registrable Securities.

  • Registration Statements means the Initial Registration Statement and the additional registration statement as proposed to be filed or as proposed to be amended by the post-effective amendment to be filed shortly prior to its Effective Time, and (iii) "Prospectus" shall mean the prospectus included in the Registration Statements.

  • Registration Date means the effective date of the first registration statement that is filed by the Company and declared effective pursuant to Section 12(g) of the Exchange Act, with respect to any class of the Company’s securities.

  • Business registration means a business registration certificate issued by the Department of the Treasury or such other form or verification that a contractor or subcontractor is registered with the Department of Treasury;

  • Incidental Registration has the meaning set forth in Section 4(a) of this Agreement.

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • Form S-4 Registration Statement means the registration statement on Form S-4 to be filed with the SEC by Parent in connection with issuance of Parent Common Stock in the Merger, as said registration statement may be amended prior to the time it is declared effective by the SEC.

  • Registration Statement means any registration statement that covers the Registrable Securities pursuant to the provisions of this Agreement, including the Prospectus included in such registration statement, amendments (including post-effective amendments) and supplements to such registration statement, and all exhibits to and all material incorporated by reference in such registration statement.

  • Initial Registration Statement means the initial Registration Statement filed pursuant to this Agreement.

  • New Registration Statement has the meaning set forth in Section 2(a).

  • Excluded Registration means (i) a registration relating to the sale of securities to employees of the Company or a subsidiary pursuant to a stock option, stock purchase, or similar plan; (ii) a registration relating to an SEC Rule 145 transaction; (iii) a registration on any form that does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered.

  • registration refer to a registration effected by preparing and filing a registration statement in compliance with the Securities Act, and the declaration or ordering of the effectiveness of such registration statement.

  • IPO Registration Statement means the Registration Statement on Form S-1 (File No. 333-196099), as amended, filed by the Partnership with the Commission under the Securities Act to register the offering and sale of the Common Units in the Partnership’s initial public offering of such Common Units to the public.

  • Original Registration Rights Agreement has the meaning set forth in the recitals to this Agreement.

  • Registration Notice has the meaning specified in Section 2.1(a).

  • Registration Fee means a fee other than the fee specified in a contract, which a personnel agency requires or accepts from a client prior to execution of a contract.