Adverse regulatory action definition

Adverse regulatory action means a denial of an ADDT license and any enforcement action taken by DPSQA pursuant to Section 803 to 807.
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Adverse regulatory action means a denial of an ADDT licenselicense, and any enforcement action taken by DPSQA the Division of Provider Services and Quality Assurance, pursuant to Section 803 to 807.
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Adverse regulatory action means a denial of an EIDT licenselicense, and any enforcement action taken by the Division of Provider Services and Quality AssuranceDPSQA pursuant to Section 803 to 807.
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Examples of Adverse regulatory action in a sentence

  • Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.

  • Adverse regulatory action, whether pre- or post-approval, can potentially lead to product liability claims and increase our product liability exposure.

  • Adverse regulatory action or adverse judgments in litigation could result in a monetary fine or penalty, adverse monetary judgment or settlement and/or restrictions or limitations on the Issuer and Servicers’ operations or result in a material adverse effect on their reputation.

  • Adverse regulatory action or adverse judgments in litigation could result in a monetary fine or penalty, adverse monetary judgment or settlement and/or restrictions or limitations on the Group’s (including the Issuer’s) operations or result in a material adverse effect on the Group’s (including the Issuer’s) reputation.

  • Alaska, 451 U.S. 259, 266 n.9 (1981)(noting that while the plain-meaning rule is not absolute, “the words used, even in their literal sense, are the primary, andordinarily most reliable, source of interpreting the measure of any writing: be it a statute, a contract, or anything else”) (quoting Cabell v.

  • And even the sixth circuit, from whence the pending case now comes.

  • Adverse regulatory action or judgment in litigation could result in sanctions of various types for the Company, including, but not limited to, the payment of fines, damages or other amounts, the invalidation of contracts, restrictions or limitations on the Company’s operations, any of which could have a material adverse effect on the Company’s business, financial condition, results of operations and/or prospects.

  • Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.Moreover, the FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval, and the sale and promotion of our product candidates.

  • In the event the instruction is given, it shall be counsel’s responsibility to remindthe court of the necessity for inclusion of the sua sponte instruction in its final charge.

  • In our discussion we will maintain the following assumption.Assumption 6 (Multiple Independent Reports) The qualification measures DS and DTare conditionally independent given D∗ and X, that is DS⊥DT |D∗, X.Moreover, in what follows we extend the non-differential error assumption 3 to hold for both measures separately:E(Y |D∗, DS, X) = E(Y |D∗, X),E(Y |D∗, DT , X) = E(Y |D∗, X).

Related to Adverse regulatory action

  • Regulatory Action means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

  • Adverse action means a home or remote state action.

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • regulatory action level RBC means the product of 1.5 and its authorized control level RBC;

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Imminent danger to the health and safety of the public means the existence of any condition or practice, or any violation of a permit or other requirement of this chapter in a surface coal mining and reclamation operation, which condition, practice, or violation could reasonably be expected to cause substantial physical harm to persons outside the permit area before such condition, practice, or violation can be abated. A reasonable expectation of death or serious injury before abatement exists if a rational person, subjected to the same conditions or practices giving rise to the peril, would not expose the person's self to the danger during the time necessary for abatement.

  • Corrective Action Plan has the meaning set forth in Section II.A.2.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • 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.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Environmental Complaint shall have the meaning set forth in Section 4.19(d) hereof.

  • Remedial Action Plan has the meaning provided in Section 3.9(c)(ii).

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Corrective action means action taken to eliminate the cause of a potential or real non- conformity or other undesirable situation;

  • Adverse employment action means an action that affects an em- ployee ’s compensation, promotion, transfer, work assignment, or performance evaluation, or any other employment action that would dissuade a reasonable employee from making or supporting a report of abuse or neglect under Family Code 261.101.

  • Emergency Action Plan means the plan referred to in Section I.G of Schedule 2 to this Agreement, detailing the activities, budget, implementation plan, and monitoring and evaluation arrangements, to respond to the Eligible Crisis or Emergency.

  • Retaliatory action means action which includes, but is not limited to, the refusal to continue an agreement, or a material reduction in the quality of service or quantity of products available to a wholesaler under an agreement, which refusal or reduction is not made in good faith.

  • Threatened species means any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.

  • Threatened litigation as used herein shall include governmental investigations and civil investigative demands. “Litigation” as used herein shall include administrative enforcement actions brought by governmental agencies. The Contractor must also disclose any material litigation threatened or pending involving Subcontractors, consultants, and/or lobbyists. For purposes of this section, “material” refers, but is not limited, to any action or pending action that a reasonable person knowledgeable in the applicable industry would consider relevant to the Work under the Contract or any development such a person would want to be aware of in order to stay fully apprised of the total mix of information relevant to the Work, together with any litigation threatened or pending that may result in a substantial change in the Contractor’s financial condition.

  • Adverse Recommendation Change has the meaning assigned in Section 5.7(f).

  • Investigating Department means any department / division / office of SCI investigating into the conduct of the Entity and shall include the Vigilance Department, “Central Bureau of Investigation, the State Police or any other authority or entity set up by the Central or State Government having powers to investigate”.

  • Third Party Action means any suit or proceeding by a person or entity other than a Party for which indemnification may be sought by a Party under Article VII.