Regulatory Scheme definition

Regulatory Scheme means the United States Public Health Service Act, the United States Food, Drug and Cosmetics 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.
View Source
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.
View Source
Regulatory Scheme means the scheme established by the Company
View Source

Examples of Regulatory Scheme in a sentence

  • 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.

  • 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.

  • 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.

  • 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).

  • Sankyo warrants that Products sold pursuant to this Agreement will be marketed and sold in all material respects: (i) in accordance with the conditions of any applicable Regulatory Approvals and any applicable labeling claims; and (ii) any applicable requirements of the Regulatory Scheme regarding the sale and/or [*] Confidential information omitted and filed separately with the Commission.

  • Except to the extent prohibited ------------------------------------- by the applicable Regulatory Scheme, BioMarin hereby assigns and BioMarin and Genzyme each hereby agree to assign to BioMarin/Genzyme LLC any "Orphan Drug" (or similar designation outside the United States) for any Collaboration Product which BioMarin has received or which BioMarin or Genzyme may receive during the term of this Agreement in the Territory.

  • HAVING regard to the Principles of Harmonization of Cosmetic Regula- tions, the Common Technical Documents for Cosmetics and the progress made in its implementation; DESIRING to implement the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme signed on 2 September 2003.

  • GelTex warrants that Product delivered to Sankyo by GelTex in accordance with the terms of Article five will conform in all material respects to: (i) the Specifications; (ii) the conditions of any applicable Regulatory Approvals regarding the Manufacturing process as specified in the NDA; and (iii) any applicable requirements of the Regulatory Scheme regarding the Manufacturing process.

  • Sankyo warrants that Compound sold pursuant to this Agreement will be marketed and sold in all material respects: (i) in accordance with the conditions of any applicable Regulatory Approvals and any applicable labeling claims; and (ii) any applicable requirements of the Regulatory Scheme regarding the sale and/or distribution of Compound.


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.
View Source
Regulatory Scheme means any regulatory scheme applicable to the Products in any country, 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.
View Source

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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Regulatory Approval means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Regulatory Authorities means the Commissions and the Exchange;