Regulatory Obligations definition

Regulatory Obligations means standards, regulations, permits or conditions required by a Governmental Authority.

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Regulatory Obligations has the meaning set forth in Section 3.15.

Regulatory Obligations means those mandatory regulatory requirements applicable to the manufacture of cGMP Product for human use in Europe, the United States of America or Japan;

Examples of Regulatory Obligations in a sentence

• The following provisions apply if you are subject to the exchange control regulations in China imposed by the State Administration of Foreign Exchange ("SAFE"), as determined by the Company in its sole discretion: Award Conditioned on Satisfaction of Regulatory Obligations.

• If the Non-Filing Party determines that any of its data or information in the Initial Draft is inaccurate or any other errors relating to the Non-Filing Party’s Regulatory Obligations, the Non-Filing Party will notify Filing Party in writing of such inaccuracy and provide a recommendation to remediate the Initial Draft.

• Prior to filing any documents or communications with a Regulatory Authority that incorporate or uses data generated by the Non-Filing Party or otherwise relate to the Non-Filing Party’s Regulatory Obligations, the Filing Party will give the Non-Filing Party a draft of such document or communication (“Initial Draft”) to give the Non-Filing Party the opportunity to verify the accuracy and regulatory validity of such Initial Draft.

• All liabilities and obligations arising out of (i) litigation and claims that arise out of an occurrence after the Closing Date, (ii) litigation and claims in respect of Future Regulatory Obligations (other than Retained Future Regulatory Obligations) regardless of when filed, and (iii) claims of a Governmental Authority arising from or related to a Future Regulatory Obligation (other than Retained Future Regulatory Obligations).

• The Filing Party shall consult with the Non-Filing Party concerning the response of the Filing Party to each such communication, unless such filing is not relevant to the Non-Filing Party’s Regulatory Obligations.

More Definitions of Regulatory Obligations

Regulatory Obligations means each and every requirement and obligation which are or may be imposed upon you, us and/or any Deposit Taker by law, regulation, court order, and/or the requirement of a regulator of a competent jurisdiction;

Regulatory Obligations means those mandatory regulatory requirements applicable in Europe and the U.S. to the manufacture of cGMP Product for human use.

Regulatory Obligations means each of those obligations proposed, or activities of Parties contemplated, by this Agreement which are subject to Regulatory Approval and, upon such approval, are enforceable under regulatory authority.

Regulatory Obligations means: (i) with respect to Flexion, any Regulatory Filings pertaining to the Product, Flexion’s Manufacturing Process, and filling and packaging processes and procedures; and (ii) with respect to Patheon, any Regulatory Filings pertaining to the Facility, including in connection with a Facility inspection by a Regulatory Authority (e.g., those described in Section 3.5). For the avoidance of doubt, Flexion shall have the sole responsibility and Regulatory Obligation for the filing of all documents with all applicable Regulatory Authorities, and to take any other actions that may be required, for the receipt of Regulatory Approval for the development or commercial manufacture of the Product. Flexion shall provide Patheon with a copy of any Regulatory Approval directly relevant to this Agreement on request including any Regulatory Approval required for the storage, receipt or distribution of the Product by Flexion or its designee.

Regulatory Obligations has the meaning set forth in Section 5.1.

Regulatory Obligations means the obligations of a licensee under the Financial Services Commission Ordinance, the Ordinance, the Regulations and the Code;

Regulatory Obligations means any obligations (whether or not legally enforceable) under any laws, codes of practice, policy, any guidance or internal policies or procedures in connection with any laws, or any valid demand from Authorities;