Compliance Issue definition

Compliance Issue means a suspected violation of a law, regulation, policy, or contract requirement governing the DCO.
View Source
Compliance Issue means an issue as to whether Finished Goods, Drug Product or Drug Substance was manufactured in accordance with cGMPs in effect when such product is shipped to Bioverativ or upon the applicable product release.
View Source
Compliance Issue means a single event during which any Accountable Employee is in violation of one or more processes or procedures required under the Rules.
View Source

Examples of Compliance Issue in a sentence

  • The Tribe and the Board or Caltrans shall meet as soon as practicable, but no later than thirty (30) days after the request to resolve the Compliance Issue is delivered to the Tribe, and shall attempt to resolve the Compliance Issue within thirty (30) days of the first meeting.

  • The Borrower and its Subsidiaries have reviewed the areas within their businesses and operations which could be adversely affected by, and have developed or are developing a program to address on a timely basis, the Year 2000 Compliance Issue.

  • Based upon such review, the Borrower reasonably believes that the Year 2000 Compliance Issue will not have any material adverse effect on the business, operations or financial condition of the Borrower and its Subsidiaries as a whole.

  • Biogen shall have no liability with respect to any damages or loss with respect to any Compliance Issue, Non-Conformity or failure to comply with Applicable Law that is caused by a Third Party Carrier.

  • If, after the release of Finished Goods or Drug Product, either Party becomes aware that any such Finished Goods are, or Drug Product is, Non-Conforming or is subject to a Compliance Issue, or that such Finished Goods are, or Drug Product is, the subject of a complaint, then such Party shall immediately notify the other Party.

  • If Biogen or Bioverativ determines that an ADP Lot or Diluent Lot or Finished Goods manufactured for Bioverativ is Non-Conforming or is subject to a Compliance Issue that, in each case, is caused by the Third Party Manufacturer, then Biogen shall be responsible to Bioverativ to the same extent that Biogen’s Third Party Manufacturer is responsible to Biogen with respect to the portion of the loss caused by the Third Party Manufacturer.

  • Additionally, if a Stockholder shall designate any person to serve as a director or observer whose appointment will result, in the Company’s reasonable determination, in a Potential Ownership Rules Compliance Issue, the Company may require such Stockholder to designate a different Person whose appointment would not, in the Company’s reasonable determination, result in a Potential Ownership Rules Compliance Issue.

  • If the Attributable Stockholder fails to respond to such notice within five (5) Business Days to request consultation with the Company as referenced in the preceding sentence or if, after any such consultation, the parties thereto reasonably determine that no Potential Company-Caused Ownership Rules Compliance Issue exists, the Company may immediately proceed to enter into the binding agreement for the acquisition of an Other Attributable Interest.

  • The Administrative Agent, the UK Agent or any Lender may request copies of technical reports prepared by any US Borrower or any of their respective Subsidiaries and such Person’s communications with any Governmental Authority to determine whether such Person is proceeding reasonably to correct, cure or contest in good faith any such Material Compliance Issue.

  • Each of the Stockholders shall, and shall cause the directors and observers designated by them to, cooperate with the Company with respect to the Company’s abilities to reasonably determine if any Potential Ownership Rules Compliance Issue arises.


More Definitions of Compliance Issue

Compliance Issue means an issue with apparent non-compliance with the ECB’s Standards
View Source

Related to Compliance Issue

  • Compliance Report means, as applicable in relation to the test being conducted, a report containing the results of the Compliance Tests carried out by State Street.

  • Compliance Review means that Digital Risk reviewed each Loan to determine, as applicable, to the extent possible and subject to the caveats below, whether the Loan complies with the applicable Federal, State, and local regulatory requirements as noted below, each as amended, restated and/or replaced from time to time.

  • Compliance Audit means the procedure (in a form advised by the GLA from time to time) by which an auditor independent of the Grant Recipient certifies (at the Grant Recipient's cost) whether the Named Projects developed or Rehabilitated pursuant to this Agreement satisfy the GLA's procedural compliance requirements (as described in the Affordable Housing Capital Funding Guide);

  • Compliance Forester means the DNR staff person(s) identified in the Pre-Work Conference who perform the compliance inspections, approve Work, recommend payment to the Contract Manager, and manage the Work Schedule.

  • Compliance Order means an order issued by the Code Enforcement Officer pursuant to subdivision (a) of section 15 of this local law.