Recall Action definition

Recall Action shall have the meaning ascribed to it in Paragraph 4.1 hereof.
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Recall Action has the meaning given in section 8.5.
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Examples of Recall Action in a sentence

  • Any and all action to be taken in connection with a Recall Action shall be in accordance with FDA policies and other applicable laws and regulations.

  • In the event a Recall Action is initiated or directed by Premier, Heritage agrees to fully cooperate and take all such steps as are reasonably requested to implement the Recall Action in a timely and complete manner.

  • In all other cases, Premier shall bear all costs associated with any Recall Action.

  • Heritage shall bear all costs, fees and out-of-pocket expenses associated with any Recall Action which results from (i) Heritage’s or Jasper’s negligence or willful misconduct, (ii) Heritage’s or Jasper’s failure to comply with Product Specifications or the Post Holdings Quality Expectations Manual set forth on Schedule A, (iii) any breach of this Agreement by Heritage or (iv) ingredients or packaging materials purchased by Heritage or Jasper.

  • At Premier’s option, Premier can direct Heritage to, and upon such direction Heritage shall, conduct such Recall Action (and Heritage shall ensure Jasper’s cooperation).

  • Manufacturer will assist Company and its Collaboration Partner in investigating any such Recall Action, if Company or its Collaboration Partner so requests, and all regulatory contacts that are made and all activities concerning such Recall Action will be initiated and coordinated by Company or, in the case of a Recall Action in an OUS Country, Collaboration Partner with Manufacturer’s involvement and assistance, as reasonably requested by Company or its Collaboration Partner.

  • MALLINCKRODT will assist AMYLIN and its Collaboration Partner in investigating any such Recall Action, if AMYLIN or its Collaboration Partner so requests, and all regulatory contacts that are made and all activities concerning such Recall Action will be initiated and coordinated by AMYLIN or, in the case of OUS Sales subject to a Recall Action, Collaboration Partner with MALLINCKRODT’s involvement and assistance, as reasonably requested by AMYLIN or its Collaboration Partner.

  • Co-Packer shall bear all costs, fees and out-of-pocket expenses associated with any Recall Action which results from (i) Co-Packer’s negligence or willful misconduct, (ii) Co-Packer’s failure to comply with Product Specifications set forth on Schedule B or the Buyer’s Quality Expectations Manual set forth on Schedule E, (iii) any breach of this Agreement by Co-Packer or (iv) ingredients or packaging materials purchased by Co-Packer.

  • Cosway agrees to cooperate with Olaplex in implementing any Recall Action in a timely and complete manner.

  • In the event both Parties have contributed to the need for a Recall Action, the Parties shall share the costs of such action in proportion to each Parties’ contribution to such action, as mutually determined by the Parties’ acting in good faith.

Related to Recall Action

  • Response Action means the investigation, cleanup, removal, remediation, containment, control, abatement, monitoring of or any other response action to the presence of Regulated Substances or Contamination in, on, at, under or emanating from the Stadium Site, including the correction or abatement of any violation required pursuant to Environmental Laws or by a Governmental Authority.

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

  • Recall means any measure aimed at achieving the return of a device that has already been made available to the end user;

  • Environmental Action means any action, suit, demand, demand letter, claim, notice of non-compliance or violation, notice of liability or potential liability, investigation, proceeding, consent order or consent agreement relating in any way to any Environmental Law, Environmental Permit or Hazardous Materials or arising from alleged injury or threat of injury to health, safety or the environment, including, without limitation, (a) by any governmental or regulatory authority for enforcement, cleanup, removal, response, remedial or other actions or damages and (b) by any governmental or regulatory authority or any third party for damages, contribution, indemnification, cost recovery, compensation or injunctive relief.

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

  • Remedial Action means all actions to (i) clean up, remove, treat, or in any other way address any Hazardous Material, (ii) prevent the Release of any Hazardous Material so it does not endanger or threaten to endanger public health or welfare or the indoor or outdoor environment, (iii) perform pre-remedial studies and investigations or post-remedial monitoring and care, or (iv) correct a condition of noncompliance with Environmental Laws.

  • Infringement Action has the meaning set forth in Section 9.6(b).

  • Material Action means to consolidate or merge the Company with or into any Person, or sell all or substantially all of the assets of the Company, or to institute proceedings to have the Company be adjudicated bankrupt or insolvent, or consent to the institution of bankruptcy or insolvency proceedings against the Company or file a petition seeking, or consent to, reorganization or relief with respect to the Company under any applicable federal or state law relating to bankruptcy, or consent to the appointment of a receiver, liquidator, assignee, trustee, sequestrator (or other similar official) of the Company or a substantial part of its property, or make any assignment for the benefit of creditors of the Company, or admit in writing the Company's inability to pay its debts generally as they become due, or take action in furtherance of any such action, or, to the fullest extent permitted by law, dissolve or liquidate the Company.

  • Tax Action means any claim, action, suit, complaint, arbitration, audit, investigation, review, assessment, notice of deficiency or other proceeding relating to any Tax or Return by or before any Tax Authority.

  • Remediation Period has the meaning specified in Section 8.2(a);

  • 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.

  • Civil action means all suits or claims of a civil nature in a state or federal court, whether cognizable as cases at law or in equity or admiralty. "Civil action" does not include any of the following:

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

  • Clean-Up Period has the meaning specified in Section 8.02(b).

  • 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.

  • Legal Action means and includes any claim, counterclaim, demand, action, suit, counterclaim, arbitration, inquiry, proceeding or investigation before any

  • third party proceeding means any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative, or investigative, other than an action by or in the right of the corporation.

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

  • Industrial Action has the meaning given to it in paragraph 1(f) of Schedule 10.4 (Force Majeure);

  • Remedial Actions means those actions taken in the event of a radioactive release or threatened release into the environment to prevent or minimize the radioactive release so that it does not migrate and cause significant danger to the present or future public health, safety, or welfare, or to the environment. Remedial action includes, but is not limited to, actions at the location of the release such as storage, confinement, perimeter protection which may include using dikes, trenches, and ditches, clay cover, neutralization, dredging or excavation, repair or replacement of leaking containers, collection of leachate and runoff, efforts to minimize the social and economic harm of processing, provision of alternative water supplies, and any required monitoring to assure that the actions taken are sufficient to protect the public health, safety, and welfare, and the environment.

  • Response activity means evaluation, interim response activity, remedial action, demolition, providing an alternative water supply, or the taking of other actions necessary to protect the public health, safety, or welfare, or the environment or the natural resources. Response activity also includes health assessments or health effect studies carried out under the supervision, or with the approval of, the department of community health and enforcement actions related to any response activity.

  • Environmental Actions means any complaint, summons, citation, notice, directive, order, claim, litigation, investigation, judicial or administrative proceeding, judgment, letter, or other communication from any Governmental Authority, or any third party involving violations of Environmental Laws or releases of Hazardous Materials from (a) any assets, properties, or businesses of any Borrower or any predecessor in interest, (b) from adjoining properties or businesses, or (c) from or onto any facilities which received Hazardous Materials generated by any Borrower or any predecessor in interest.