Regulatory Scheme definition

Regulatory Scheme means the United States Public Health Service Act and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to the Collaboration Products in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time.
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Regulatory Scheme means the U.S. Food, Drug and Cosmetics Act and the regulations, interpretations and guidelines promulgated thereunder by the FDA or the regulatory scheme applicable to Aldurazyme in any country other than the United States, as such statutes, regulations, interpretations and guidelines or regulatory schemes may be amended from time to time.
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Regulatory Scheme means the scheme established by the Company
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Examples of Regulatory Scheme in a sentence

  • As a result of this collaboration, the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) was signed on 2 September 2003.

  • The following are the highlights of the ASEAN Harmonized Cosmetic Regulatory Scheme Common Technical Documents.

  • All cosmetic products manufactured in or imported from non-ASEAN Member countries or ASEAN Member Countries have to comply with the ASEAN Harmonized Cosmetic Regulatory Scheme and its technical documents.

  • Revising Model Rule 5.4: Adopting a Regulatory Scheme that Permits Nonlawyer Ownership and Management of Law Firms” (2008) 48 Washburn L J 669 at 673.

  • The entity in whose name such Regulatory Approval filings are filed shall give each of the Parties a right of reference in such filings if such right is not prohibited under the applicable Regulatory Scheme.

  • Notwithstanding the foregoing provisions of this Section 7.3.1, to the extent required by the Regulatory Scheme, any entity selected by the Steering Committee pursuant to Section 5.3 above may be engaged by Kallikrein LLC to manufacture Collaboration Products.

  • Except to the extent prohibited by the Regulatory Scheme, the Parties agree to assign to Kallikrein LLC on the LLC Formation Date any "Orphan Drug" designations for any Collaboration Product which Dyax or Genzyme may receive during the term of this Agreement.

  • Dyax warrants that any Collaboration Products delivered by Dyax pursuant to Sections 7.2 or 7.3 hereof will conform in all material respects to the Specifications, the conditions of any applicable Regulatory Approvals regarding the manufacturing process and any applicable requirements of the Regulatory Scheme regarding the manufacturing process.

  • Supernus shall purchase all such Product ordered and delivered by the delivery date specified in an Acknowledgement, provided that such Product meets the Specifications and the Regulatory Scheme, including, without limitation, cGMP.

  • Genzyme warrants that the Aldurazyme sold pursuant to Article 4 hereof will be marketed and sold in all material respects in accordance with the conditions of any applicable Marketing Application Approvals, Regulatory Approvals, any applicable labeling claims and any applicable requirements of the Regulatory Scheme regarding the promotion, sale and marketing of Aldurazyme (except to the extent any of the foregoing is the responsibility of BioMarin as the holder of the BLA).


More Definitions of Regulatory Scheme

Regulatory Scheme means any regulatory scheme promulgated by a Regulatory Authority applicable to the Products in any country in the Territory, as such statutes, regulations, interpretations and guidelines or regulatory schemes that may be amended from time to time, including, without limitation, the statutes, regulations, interpretations, and guidelines administered by the FDA.
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Regulatory Scheme means the United States Federal Food, Drug and Cosmetic Act and the regulations, interpretations and guidelines promulgated under that Act by the FDA or the corresponding regulatory scheme applicable to the Collaboration Product in any country other than the United States, as such statutes, regulations, interpretations and guidelines or corresponding regulatory schemes may be amended from time to time.
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Related to Regulatory Scheme

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Authority means any federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • DP Regulator means any governmental or regulatory body or authority with responsibility for monitoring or enforcing compliance with the Data Protection Laws;

  • Bank Regulator means any Federal or state banking regulator, including but not limited to the OCC and the FRB, which regulates NBT, NBT Bank, Evans or Evans Bank, or any of their respective subsidiaries, as the case may be.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • EMA means the European Medicines Agency or any successor agency thereto.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Signing Authority means an officer or agent of the organization with written authorization to commit the legal entity to a binding agreement.

  • 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.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;