Drug Product Recalls. In the event: (a) any government authority issues a request, directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled, or (d) BIONICHE recommends to CUMBERLAND that a recall be initiated, the parties shall take all appropriate corrective actions; provided that a recall pursuant to Subparagraph 6.1 (c) shall be without prejudice to the parties’ rights under Paragraph 2.5. In the event that BIONICHE recommends a recall of Drug Product by CUMBERLAND, such recommendation must take the form of a notice as per Paragraph 11.1, and CUMBERLAND shall respond promptly indicating to BIONICHE whether the Drug Product will be recalled. In no event, however, shall BIONICHE have responsibility for regulatory compliance in connection with any recall, except to the extent and under the circumstances set forth in the Manual or any other written agreement between the parties hereto or as required by law. All costs and expenses incurred in connection with such recall shall be the responsibility of CUMBERLAND unless caused by the negligence of BIONICHE.
Drug Product Recalls. In the event: (a) any government authority issues a request, directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled because the Drug Product does not conform to Specifications, or (d) FAULDING recommends to CUMBERLAND that a recall be initiated, the parties shall take all appropriate corrective actions. In the event that FAULDING recommends a recall of Drug Product by CUMBERLAND, such recommendation must take the form of a notice as per Paragraph 14.1, and CUMBERLAND shall respond promptly indicating to FAULDING whether the Drug Product will be recalled. In no event, however, shall FAULDING have responsibility for regulatory compliance in connection with any recall, except to the extent and under the circumstances set forth in the Manual or any other written agreement between the parties hereto or as required by law. All costs and expenses incurred in connection with such recall shall be the responsibility of CUMBERLAND unless caused by the negligence of FAULDING.
Drug Product Recalls. In the event CLIENT shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Drug Product Specifications, or in the event that CLIENT elects to institute a voluntary recall, CLIENT shall be responsible for coordinating such recall. CLIENT promptly shall notify XXXXXX if any Drug Product is the subject of a recall and provide XXXXXX with a copy of all documents relating to such recall. XXXXXX shall cooperate with CLIENT in connection with any recall, at CLIENT’s expense. CLIENT shall be responsible for all of the costs and expenses of such recall.
Drug Product Recalls. In the event CLIENT shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Drug Product Specifications, or in the event that CLIENT elects to institute a voluntary recall, CLIENT shall be responsible for coordinating such recall. CLIENT promptly shall notify XXXXXX if any Drug Product is the subject of a recall and the basis for such recall. CLIENT shall provide XXXXXX with a copy of all documents concerning such recall that are related to the Development or Production services provided by XXXXXX to CLIENT. XXXXXX shall cooperate with CLIENT in connection with any recall, at CLIENT’s expense. CLIENT shall be responsible for all of the costs and expenses of such recall, except to any extent that XXXXXX may have an obligation to indemnify CLIENT in accordance with the provisions of Section 13.2.
Drug Product Recalls. In the event NUVELO shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Specifications for Drug Product, or in the event that NUVELO elects to institute a voluntary recall, NUVELO shall be responsible for coordinating such recall. NUVELO promptly shall notify BPS if any Drug Product is the subject of a recall as a result of any of the services performed in accordance with this Agreement and provide BPS with a copy of all documents relating to such recall. BPS shall cooperate with NUVELO in connection with any recall. To the extent a recall is caused by [ * ], or [ * ] and such recall occurs within [ * ] of the date of manufacture, BPS shall bear all reasonable costs and expenses associated with the recall [ * ]. Notwithstanding the foregoing, [ * ] [ * ] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.
Drug Product Recalls i. In the event: (i) any government authority issues a request, directive or order that the Drug Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or (iii) CLIENT reasonably determines that the Drug Product should be recalled because the Drug Product does not conform to Specifications, the parties shall take all appropriate corrective actions. In no event, however, shall HYALURON have responsibility for regulatory compliance in connection with any recall, except to the extent and under the circumstances as required by law. All costs and expenses incurred in connection with such recall shall be the responsibility of CLIENT unless caused primarily by the negligence or willful misconduct of HYALURON or breach by HYALURON of the warranties set forth above or of any other term of this Agreement.
Drug Product Recalls. In the event CLIENT shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Drug Product Specifications, or in the event that CLIENT elects to institute a voluntary recall, CLIENT shall be responsible for coordinating
Drug Product Recalls. In the event that NTI shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency, or the Drug Product Specifications, or in the event that NTI elects to institute a voluntary recall of any Drug Product, NTI shall be responsible for coordinating such recall. NTI promptly shall notify BPS if any Drug Product is the subject of a recall, and shall provide BPS with a copy of all documents relating to such recall. BPS shall cooperate with NTI in connection with any such recall, at NTI’s expense. NTI shall be responsible for all of the costs and expenses of such recall.
Drug Product Recalls. In the event Altus shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that Altus elects to institute a voluntary recall, Altus shall be responsible for coordinating such recall. Altus promptly shall notify Xxxxxx if any Drug Product is the subject of a recall and provide Xxxxxx with a copy of all documents relating to such recall. Xxxxxx shall cooperate with Altus and provide Altus all reasonable assistance in connection with any recall, at Altus' expense. Altus shall be responsible for all of the costs and expenses of such recall, including Althea's actual out-of-pocket costs in providing assistance; except as otherwise provided in the following. [***] Xxxxxx that[***] Xxxxxx (but [***], Xxxxxx [***] Altus, [***] that was the [***] [***]
Drug Product Recalls. In the event: (a) any government authority issues a request, directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled because the Drug Product does not conform to Specifications, or (d) FAULDING recommends to CUMBERLAND that a recall be initiated, the parties shall take all appropriate corrective actions. In the event that FAULDING recommends a recall of Drug Product by CUMBERLAND, such recommendation must take the form of a notice as per Paragraph 14.1, and CUMBERLAND shall respond promptly indicating to FAULDING whether the Drug
