Voluntary Recall Sample Clauses

Voluntary Recall. Each Party shall notify the other Party in writing of any facts relating to the advisability of a voluntary recall or withdrawal of the Product from any market. Auxilium shall have the right, acting reasonably, to initiate a voluntary recall in the countries in which it holds the Marketing Authorizations. In case of a voluntary recall initiated by Auxilium, Auxilium shall immediately give written notice to Ipsen of such action and all particulars thereof and review with Ipsen the proposed manner in which the recall is to be carried out. In the event Ipsen reasonably believes a voluntary Product recall or withdrawal in the Territory should be made for reasons of patient safety, Ipsen shall promptly notify Auxilium of its belief in writing and provide Auxilium with all supporting information or documentation. Auxilium’s approval must be obtained in writing, within a time period reasonable in the specific circumstance, for any voluntary recall and any notice of or letters relating to any recall. In the event that Ipsen and Auxilium cannot agree that a voluntary recall should be made for safety reasons and Ipsen decides to definitively withdraw from marketing the Product for product safety related concerns (such as pharmacovigilence issues) in any country in the Territory, Ipsen shall not take any action towards voluntarily withdrawing the Product from the market but Ipsen shall revert all license rights as granted under Section 2 of this Agreement with respect to the affected countries to Auxilium in a timely manner.
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Voluntary Recall. In the event that DEBIOTECH or IMED reasonably believes that any Product or Accessory violates any provision of applicable law, rule or regulation or should be recalled due to health or safety considerations, DEBIOTECH and IMED shall consult in good faith concerning the necessity for implementing any action and the means of implementing the same and shall mutually agree to take such action in respect thereof as is necessary. In such an event, the Voluntary Recall shall be treated in accordance with Article 11.3(a) hereabove, including, without limitation, calculation of costs.
Voluntary Recall. If Company voluntarily recalls an item for any reason (a “Voluntary Recall”), Company will (a) immediately notify Intermountain’s recall center at (000) 000-0000, and xxxxxxx@xxxxx.xxx; (b) within 24 hours of the Voluntary Recall, provide Intermountain a written proposal of the corrective action to be taken by Company as a result of the Voluntary Recall , which corrective action is subject to Intermountain’s review and approval; (c) perform the corrective action approved by Intermountain; and (d) within 30 days of Intermountain’s request, reimburse Intermountain for any costs it incurs as a result of the Voluntary Recall.
Voluntary Recall. If a Party believes that a voluntary withdrawal or recall of a Product is necessary both Parties will mutually agree to the need for a recall. If the Parties cannot agree, they will use an independent third party qualified to assess the need for a recall and will follow the recommendation of the third party. INO-T will assist AGA, to the extent necessary in implementing the withdrawal or recall. Any and all costs related to the recall should be paid by the Party which is responsible for the recall.
Voluntary Recall. In the event that either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party desiring such recall or similar action shall, within twenty-four (24) hours, advise the other Party thereof by telephone (and confirm by email or facsimile), email or facsimile. Following notification of a voluntary recall in the Territory, the Parties shall decide through the JSC whether to conduct a recall and the manner in which any such recall shall be conducted. In any case of dispute, Section 3.4 shall apply.
Voluntary Recall. If either Party desires to recall OT-fentanyl Products for non-conformities with Specifications (other than such non- conformities that would require recall pursuant to the requirements of applicable laws or regulations), it shall so notify the other Party. If the other Party does not agree that the relevant OT-fentanyl Products do not comply with Specifications, the dispute shall be settled as set forth in Section 5.8(c). If the Parties agree as to such non-conformity or such non-conformity is determined pursuant to Section 5.8(c), then the Party desiring the recall shall administer the recall in a commercially reasonable manner with the other Party"s cooperation. If one Party"s actions were the sole cause of the non-conformity with Specifications, such Party shall bear all costs and expenses of the recall.
Voluntary Recall. (a) If a Party believes that a voluntary withdrawal or recall of a Product is necessary, both Parties shall promptly use their respective commercially reasonable efforts to agree whether it is necessary. If the Parties agree that it is necessary, in respect of the Linde Territories, AGA shall carry out that withdrawal or recall and, in respect of countries outside the Linde Territories and the Existing ROW Territories, INO-T shall carry out that withdrawal and recall. If the Parties cannot agree, in respect of a proposed voluntary withdrawal or recall:
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Voluntary Recall. If either Party establishes a need to recall a Product for non-conformities with the Product specifications therefor (other than such non-conformities that would require recall pursuant to the requirements of applicable laws or regulations), it shall so notify the other Party. If the other Party does not agree that the relevant Product does not comply with such specifications, the dispute shall be settled as set forth in Clause 5.10. If the Parties agree as to such non-conformity or such non-conformity is determined pursuant to Clause 5.10, then a decision shall be made mutually as to the appropriate Party that will lead/coordinate the recall in a commercially reasonable manner with the other Party's full cooperation. The lead/coordination role shall typically be taken by the holder of the Regulatory Approval in the country in which the recall is to take place with full consultation by the other Party. A joint recall administration team shall be established with an equal number of nominated individuals from both Parties participating. A final report must be completed by the recall administration team and delivered promptly to the other Party.

Related to Voluntary Recall

  • Voluntary Reduction The Borrower shall have the right at any time and from time to time, upon at least five (5) Business Days prior written notice to the Administrative Agent, to permanently reduce, without premium or penalty, (i) the entire Revolving Credit Commitment at any time or (ii) portions of the Revolving Credit Commitment, from time to time, in an aggregate principal amount not less than $3,000,000 or any whole multiple of $1,000,000 in excess thereof. Any reduction of the Revolving Credit Commitment shall be applied to the Revolving Credit Commitment of each Revolving Credit Lender according to its Revolving Credit Commitment Percentage. All Commitment Fees accrued until the effective date of any termination of the Revolving Credit Commitment shall be paid on the effective date of such termination.

  • Voluntary Resignation without Good Reason The Executive may voluntarily terminate employment without Good Reason upon 30 days’ prior written notice to the Company. In such event, after the effective date of such termination, no payments shall be due under this Agreement, except that the Executive shall be entitled to any Accrued Obligations.

  • Voluntary Resignation (2) Discharge for just cause.

  • Voluntary Reductions The Borrower shall have the right to terminate or permanently reduce the unused portion of the Revolving Committed Amount at any time or from time to time upon not less than five (5) Business Days’ prior written notice to the Administrative Agent (which shall notify the Lenders thereof as soon as practicable) of each such termination or reduction, which notice shall specify the effective date thereof and the amount of any such reduction which shall be in a minimum amount of $1,000,000 or a whole multiple of $1,000,000 in excess thereof and shall be irrevocable and effective upon receipt by the Administrative Agent; provided that no such reduction or termination shall be permitted if after giving effect thereto, and to any prepayments of the Revolving Loans made on the effective date thereof, the sum of the aggregate principal amount of outstanding Revolving Loans plus outstanding Swingline Loans plus outstanding LOC Obligations would exceed the Revolving Committed Amount then in effect.

  • Voluntary Resignation by Executive Without Good Reason Executive may voluntarily resign Executive’s position with Company without Good Reason, at any time after the Initial Term, on thirty (30) days’ advance written notice. In the event of Executive’s resignation without Good Reason, Executive will be entitled to receive only the Base Salary for the thirty-day notice period and no other amount for the remaining months of the current term, if any. All other Company obligations to Executive pursuant to this Agreement will become automatically terminated and completely extinguished. In addition, executive will not be entitled to receive the Severance Payment described in subparagraph 7.2 above.

  • Voluntary Resignation or Termination for Cause If the Employee's employment with the Company terminates as a result of the Employee's voluntary resignation which is not an Involuntary Termination or if the Employee is terminated for Cause at any time after a Change of Control, then the Employee shall not be entitled to receive severance or other benefits hereunder, but may be eligible for those benefits (if any) as may then be established under the Company's then existing severance and benefits plans and policies at the time of such termination.

  • Voluntary Resignation by Executive Executive may voluntarily resign Executive’s position with Company for any reason, at any time after the Effective Date, on five (5) days’ advance written notice. In the event of Executive’s resignation, Executive will be entitled to receive only the Base Salary for the five-day notice period and no other amount (other than amounts to which Executive is entitled pursuant to Section 5 or 6 hereof). All other Company obligations to Executive pursuant to this Agreement will become automatically terminated and completely extinguished upon termination of employment. In addition, Executive will not be entitled to receive any other Severance Benefits described in Section 7.2, above. The provisions of this Section 7.4 shall not apply to Executive’s resignation for Good Reason.

  • Voluntary Termination Without Good Reason Upon 30 days prior written notice to Company, Executive shall have the right to voluntarily terminate his employment hereunder for other than Good Reason. Upon receipt of Executive’s notice of voluntary termination, Company at its sole discretion may elect to reduce the notice period and no such action by Company shall cause Executive’s termination to be a termination by Company without Cause. In such event of Executive’s voluntary termination, Executive shall be entitled to the Accrued Obligations earned through the Termination Date.

  • Voluntary Termination for Good Reason “Voluntary Termination for Good Reason” shall mean the Employee voluntarily resigns after the occurrence of any of the following (i) without the Employee’s express written consent, a material reduction of the Employee’s duties, title, authority or responsibilities, relative to the Employee’s duties, title, authority or responsibilities as in effect immediately prior to such reduction, or the assignment to Employee of such reduced duties, title, authority or responsibilities; provided, however, that a reduction in duties, title, authority or responsibilities solely by virtue of the Company being acquired and made part of a larger entity (as, for example, when the Senior Vice-President of a business unit of the Company remains as such following a Change of Control) shall not by itself constitute grounds for a “Voluntary Termination for Good Reason;” (ii) without the Employee’s express written consent, a material reduction, without good business reasons, of the facilities and perquisites (including office space and location) available to the Employee immediately prior to such reduction; (iii) a reduction by the Company in the base salary of the Employee as in effect immediately prior to such reduction; (iv) a material reduction by the Company in the aggregate level of employee benefits, including bonuses, to which the Employee was entitled immediately prior to such reduction with the result that the Employee’s aggregate benefits package is materially reduced (other than a reduction that generally applies to Company employees); (v) the relocation of the Employee to a facility or a location more than thirty-five (35) miles from the Employee’s then present location, without the Employee’s express written consent; (vi) the failure of the Company to obtain the assumption of this agreement by any successors contemplated in Section 7(a) below; or (vii) any act or set of facts or circumstances which would, under California case law or statute constitute a constructive termination of the Employee.

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