Post-Registration Studies definition

Post-Registration Studies means Clinical Studies which are conducted in a particular country after the attainment of Regulatory Approval from the appropriate Regulatory Agency in that country, which studies are conducted for a variety of purposes including, but not limited to, post-marketing surveillance and/or other studies intended to confirm or enhance the commercial profile of the particular Licensed Product.
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Post-Registration Studies means clinical studies which are conducted in a particular country after the obtainment of REGULATORY APPROVAL from the appropriate regulatory agency in that country, which studies are conducted for the purpose of enhancing commercial acceptability of a PRODUCT.
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Post-Registration Studies means such studies as may be required to be conducted by any Regulatory Authority to maintain the Registration and any other studies as may be desired by Kos in respect of the Product.
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Examples of Post-Registration Studies in a sentence

  • Her title appears, for example, in Esarhaddon’s treaties (SAA II 5, rev.

  • Alpharma shall bear the Costs of all Alpharma Post-Registration Studies.

  • All clinical Data generated during the course of such Post-Registration Studies of any Product under Section 6.4 shall be owned by MINERALYS and shall be included in MINERALYS Know-How.

  • For the avoidance of doubt, Braeburn Post-Registration Studies shall include any Clinical Trials required as a condition to, or for the maintenance of, Regulatory Approval of the Product in the Licensed Territory.

  • Alpharma shall also promptly provide to Durect a copy of final protocols and reports from such Alpharma Post-Registration Studies.

  • MINERALYS may, in its sole discretion, conduct Post-Registration Studies of Product at its own expense in the MINERALYS Territory.

  • Braeburn shall bear the cost of all Braeburn Post-Registration Studies.

  • Alpharma shall consider in good faith all comments provided by Durect in writing within the [* * *] period following Durect’s receipt of such protocols; provided, that Alpharma shall have the sole discretion and authority to make all decisions with respect to the final protocols and all other matters relating to Alpharma Post-Registration Studies.

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  • Already, the government’s KUR scheme can be leveraged and will ensure broad adoption of the tools and f inancing facility by the banks.

Related to Post-Registration Studies

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

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

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

  • 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.

  • 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.

  • Product Registrations means all registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, or sale of the Product within the Geographic Territory, including all Applications in existence for the Product as of the Closing Date.

  • Rule 462(b) Registration Statement means a registration statement and any amendments thereto filed pursuant to Rule 462(b) relating to the offering covered by the registration statement referred to in Section 1(a) hereof.

  • 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.

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

  • Special Registration Statement means (i) a registration statement relating to any employee benefit plan or (ii) with respect to any corporate reorganization or transaction under Rule 145 of the Securities Act, any registration statements related to the issuance or resale of securities issued in such a transaction or (iii) a registration related to stock issued upon conversion of debt securities.

  • Company IP Registrations means all Company Intellectual Property that is subject to any issuance, registration or application by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including issued patents, registered trademarks, domain names and copyrights, and pending applications for any of the foregoing.

  • Company Registration Statement means the Registration Statement, including the Prospectus, amendments and supplements to the Registration Statement or Prospectus, including pre- and post-effective amendments, all exhibits thereto, and all material and exhibits incorporated by reference or deemed to be incorporated by reference in such registration statement.

  • 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;

  • Resale Registration Statement means a registration statement under the Securities Act registering the Securities for resale pursuant to the terms of the Registration Rights Agreement.

  • Exchange Registration Statement shall have the meaning assigned thereto in Section 2(a) hereof.

  • 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.

  • Special Registration means the registration of (A) equity securities and/or options or other rights in respect thereof solely registered on Form S-4 or Form S-8 (or successor form) or (B) shares of equity securities and/or options or other rights in respect thereof to be offered to directors, members of management, employees, consultants, customers, lenders or vendors of the Company or Company Subsidiaries or in connection with dividend reinvestment plans.

  • 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).

  • Demand Registration Statement has the meaning set forth in Section 2.01(a).

  • 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.

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

  • 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 Filing Date means the date that is sixty (60) calendar days after the Effective Date.

  • Underlying Shares Registration Statement means a registration statement meeting the requirements set forth in the Registration Rights Agreement, covering among other things the resale of the Underlying Shares and naming the Holder as a "selling stockholder" thereunder.

  • Piggyback Registration Statement has the meaning set forth in Section 3(a).

  • Subsequent Shelf Registration Statement has the meaning set forth in Section 2(b) hereof.