Regulatory Registrations definition

Regulatory Registrations means the premarket notifications or premarket approvals issued by the FDA, European Union Conformity Marking (XX xxxxx) issued by a European Union Notified Body, and all other technical, medical, scientific, Labeling and similar licenses, registrations, authorizations, permits, certifications, franchises, variances, exemptions, orders, approvals, amendments and renewals of the Products (including marketing authorizations and Labeling approvals) issued by the Regulatory Authorities of any country and held or pending (including any applications) as of the Closing Date by Sellers or any of their Controlled Affiliates or third party distributors (under rights of reservation of such Seller) that are required for the manufacture, commercialization, Labeling, distribution, use, storage, import, export, transport, marketing or sale of the Products within any country.
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Regulatory Registrations means the premarket notifications or premarket approvals issued by the FDA, European Union Conformity Marking (CE marks) issued by a European Union Notified Body, and all other technical, medical, scientific, labeling and similar licenses, registrations, authorizations, permits, certifications, franchises, variances, exemptions, orders, approvals, amendments and renewals of the Products (including marketing authorizations and labeling approvals) issued by any Governmental Authority of any country and held or pending (including any applications) as of the Closing Date by Seller or any Selling Affiliate or third-party distributors (under rights of reservation of such seller) that are required for the manufacture, commercialization, labeling, distribution, use, storage, import, export, transport, marketing or sale of the Products within any country, including the approved FDA New Drug Application for the Product.
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Regulatory Registrations means all investigational new drug applications, new drug applications, product license application, or biologics license application or similar regulatory applications of the Company and its Subsidiaries that have been submitted to or approved by the FDA or any applicable Governmental Entity. All applications, notifications, submissions, information, claims, reports and statistics and other data, utilized as the basis for or submitted in connection with any and all Regulatory Registrations from the FDA or other Regulatory Authority relating to the Company and its Subsidiaries or their respective business operations and Pharmaceutical Products, when submitted to the FDA or other Regulatory Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authority.
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Examples of Regulatory Registrations in a sentence

  • There are no Proceedings pending or, to Seller Parent’s Knowledge, threatened which would reasonably be expected to result in the material limitation, material adverse modification, revocation, cancellation or suspension of any material Permits or Regulatory Registrations.

  • In the event that Regulatory Registrations or Permits required for the distribution of the Products can be held by more than one Person, Buyer Parent undertakes to ensure that Buyers hold at or prior to the Closing all such Regulatory Registrations and Permits.

  • Following the transfer of the Regulatory Registrations, Seller shall not retain any rights in any Regulatory Registration included in the Acquired Assets or (except as otherwise provided in this Agreement) Books and Records, including any rights to use or reference.

  • If the Borrower fails to perform or comply with any of their agreements contained in the Loan Documents and the Lender may itself perform or comply, or otherwise cause performance or compliance, with such agreement, the expenses of the Lender incurred in connection with such performance or compliance, together with interest thereon at a rate per annum equal to the Post-Default Rate, shall be payable by the Borrower to the Lender on demand and shall constitute Secured Obligations.

  • For avoidance of doubt, ARC shall be required, at its expense (except as expressly provided in this Agreement), to obtain and maintain all Regulatory Approvals required for the Registered Facility to comply with the requirements of the FDA, the Specifications and the Quality Agreement and shall be required to obtain and maintain all Regulatory Registrations and Approvals necessary in order for the Batches and Products to be manufactured according to cGMP, cGTP and cGCP.

  • All Transfer Taxes resulting from the transfer by Sellers of the Acquired Assets to Buyers, including the transfer of the Regulatory Registrations and the Transferred Intellectual Property (collectively, “Shared Transfer Taxes”), shall be borne fifty-percent (50%) by Buyers and fifty-percent (50%) by Sellers provided, that interest, additions and penalties that arise as a result of a Person’s failure to timely and properly pay its portion of the Transfer Taxes shall be borne exclusively by such Person.

  • Except with respect to Argatroban, Buyer shall use commercially reasonable efforts to establish its own National Drug Code (“NDC”) numbers with respect to the Products as soon as practicable (and in any event within thirty (30) days) after Seller Parent has transferred to Buyer the Regulatory Registrations for the Products that include Seller Parent’s most recent structured product labeling submission.

  • As of the Closing, the Acquired Entities in France, Germany and Japan will hold, if and to the extent freely transferable by Sellers to the Acquired Entities, or through third-party distributors or dealers have the beneficial use of, all material Permits and Regulatory Registrations that are required for the conduct of the Business as it is being conducted in France, Germany and Japan, as applicable, and such Permits and Regulatory Registrations are valid and in full force and effect.

  • Except with respect to Argatroban, Buyer shall use commercially reasonable efforts to establish its own National Drug Code (“NDC”) numbers with respect to the Products as soon as practicable (and in any event within thirty (30) days) after 58 Seller Parent has transferred to Buyer the Regulatory Registrations for the Products that include Seller Parent’s most recent structured product labeling submission.

  • There are no Proceedings pending or, to Seller Parent’s Knowledge, threatened in writing which would reasonably be expected to result in the revocation, cancellation or suspension of any Regulatory Registrations.


More Definitions of Regulatory Registrations

Regulatory Registrations means the premarket notifications or premarket approvals issued by the FDA, European Union Conformity Marking (XX xxxxx) issued by a European Union Notified Body, and all other technical, medical, scientific, Labeling and similar licenses, registrations, authorizations, permits, certifications, franchises, variances, exemptions, orders, approvals, amendments and renewals of the Products (including marketing authorizations and Labeling approvals) issued by the Regulatory Authorities of any country and held or pending (including any applications) as of the Closing Date by Seller Parent or any of its Subsidiaries or third-party distributors (under rights of reservation of Seller Parent or any of its Subsidiaries) that are required for the manufacture, commercialization, Labeling, distribution, use, storage, import, export, transport, marketing or sale of the Products within any country.
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Regulatory Registrations means the premarket approvals issued by the FDA, CE markings of conformity, including underlying certifications, registrations and/or declarations, product, marketing and repair authorizations issued by the Minister of Health, Labor and Welfare of Japan, and all other technical, medical, scientific, labeling, importation, distribution and similar licenses, registrations, authorizations, permits and approvals of the Products (including marketing authorizations and labeling approvals) issued by the Regulatory Authorities of any country and held as of the Closing Date by Sellers that are required for the marketing, promotion, distribution or sale of the Products within any country, all of which are listed on Schedule 2.1(f). Where the context so requires “Regulatory Registrations” also includes those held by third party distributors and dealers.
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Related to Regulatory Registrations

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

  • Product Registrations means the approvals, licenses, registrations, listings, franchises, permits, certificates, consents, clearances, or other authorizations (including, but not limited to, NDAs and NDSs) and comparable regulatory filings required by any Governmental Authority for the Products held in Sellers’ name as set forth in Schedule 1.1(d).

  • 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;

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • Book-Entry Registration Settlement in "same-day" funds, to the extent practicable. REMIC residual certificates will not be issued in book-entry form, unless authorized by the Seller.

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

  • Exchange Registration shall have the meaning assigned thereto in Section 3(c) hereof.

  • 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.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • 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.

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

  • 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).

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

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

  • 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 Agency means the Apprenticeship Branch, of the Ministry of Skills Development.

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

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

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

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

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

  • Registration Filing Date means the date that is ninety (90) calendar days after the Effective Date.

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

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.