Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Product delivered to the Client or customers of the Client. Each party shall promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product and/or which might result in the Recall or seizure of the Product. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. For purposes of this Agreement, "Recall" shall mean any action (i) by the Client to recover title to or possession of quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Product. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Product to third parties which would have been subject to a Recall if sold or shipped. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 3 contracts
Samples: Manufacturing Services and Supply Agreement, Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc)
Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Drug Product delivered to the Client or customers of the Client. Each party shall promptly notify the other by telephone (to be confirmed in writing) of any information information, which might affect the marketability, safety or effectiveness of the Drug Product and/or which might result in the Recall or seizure of the Drug Product. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such Drug Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. For purposes of this Agreement, "“Recall" ” shall mean any action action: (i) by the Client to recover title to or possession of quantities of the Drug Product sold or shipped to third third-parties (including, without limitation, the voluntary withdrawal of Drug Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Drug Product. Recall “Recall” shall also include any action by either party to refrain from selling or shipping quantities of the Drug Product to third third-parties which would have been subject to a Recall if sold or shipped. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 3 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Drug Product delivered to the Client or customers of the Client. Each party shall promptly notify the other by telephone (to be confirmed in writing) of any information information, which might affect the marketability, safety or effectiveness of the Drug Product and/or which might result in the Recall or seizure of the Drug Product. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such Drug Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. For purposes of this Agreement, "“Recall" ” shall mean any action action: (i) by the Client to recover title to or possession of quantities of the Drug Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Drug Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Drug Product. Recall “Recall” shall also include any action by either party to refrain from selling or shipping quantities of the Drug Product to third parties which would have been subject to a Recall if sold or shipped. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Product Products delivered to the Client or customers of the Client. Each party Party shall promptly notify the other by telephone (to be confirmed in writingwriting within the first following Business Day) of any information information, which might affect affects the marketability, safety or effectiveness of the Product and/or Product, and which might may result in the Recall or seizure of the Product. Upon receiving any such notice or upon any such discovery, each party Party shall cease and desist from further shipments of such the affected Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client. For purposes of this Agreement, "“Recall" ” shall mean any action action: (i) by the Client to recover title to or possession of quantities of the Product Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product Products from the market); or (ii) by any regulatory authorities Regulatory Authorities to detain or destroy any of the Product. Recall shall also include any action Products; or (iii) by either party Party to refrain from selling or shipping quantities of the Product Products to third parties which would have been subject to a Recall if sold or shipped. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Zymogenetics Inc)
Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall (as defined below) of any Product Products delivered to the Client or customers of the Client. Each party **** shall promptly notify the other **** by telephone (to be confirmed in writing) of any information which might is reasonably likely to adversely affect the marketability, safety or effectiveness of the Product Products in a material manner and/or which might result in the Recall or seizure of the ProductProducts. Upon receiving any such notice or upon any such discovery, each party **** shall cease and desist from further shipments of such Product Products in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by the Client****. For purposes of this Agreement, "“Recall" ” shall mean any action (i) by the Client to recover title to or possession of quantities of the Product Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the ProductProducts. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Product Products to third parties which would have been subject to a Recall if sold or shipped. [ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)