Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any 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 affect the marketability, safety or effectiveness of the Products and/or which might result in the Recall or seizure of the Products. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such 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. "RECALL" shall mean any action (i) by the Client to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)
Records and Notice. Patheon Mylan and the Client Somaxon shall each maintain such records as may be necessary to permit a Recall of any Products delivered to the Client Somaxon or customers of the ClientSomaxon. 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 Products and/or which might result in the Recall or seizure of the Products. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such 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 ClientSomaxon. "RECALL" “Recall” shall mean any action (i) by the Client Somaxon to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Somaxon Pharmaceuticals, Inc.)
Records and Notice. Patheon and the Client Customer shall each maintain such records as may be necessary to permit a Recall of any Products batch delivered to the Client Customer or customers of the ClientCustomer. 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 Products and/or which might result in the Recall or seizure of the Products. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such Products batches 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 ClientCustomer. "RECALLRecall" shall mean any action (i) by the Client Customer to recover title to or possession of quantities batches of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 1 contract
Records and Notice. Patheon NPI and the Client shall CUSTOMER will each maintain such records as may be necessary to permit a Recall of any Products delivered to the Client CUSTOMER or customers of the ClientCUSTOMER. Each party shall Party will promptly notify the other by telephone (to be confirmed in writing) of any information which that might affect the marketability, safety or effectiveness of the Products and/or which that might result in the Recall or seizure of the Products. Upon receiving any such this notice or upon any such this discovery, each party shall Party will cease and desist from further manufacturing and/or shipments of such any 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 will be made and implemented by the ClientCUSTOMER. "RECALL" shall “Recall” will mean any action (i) by the Client CUSTOMER to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall shall will also include any action by either party Party to refrain from manufacturing, selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)
Records and Notice. Patheon and the Client Éclat shall each maintain such records as may be necessary to permit a Recall of any Products delivered to the Client Éclat or customers of the ClientÉclat. 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 Products and/or which might result in the Recall or seizure of the Products. Upon receiving any such notice or upon any such discovery, each party shall cease and desist from further shipments of such 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 ClientÉclat. "RECALL" “Recall” shall mean any action (i) by the Client Éclat to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall shall also include any action by either party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)
Records and Notice. Patheon and the Client shall each maintain such records as may be necessary to permit a Recall of any Products delivered to the Client or customers of the Client. Each party 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 Products and/or which might result in the Recall or seizure of the Products. Upon receiving any such notice or upon any such discovery, each party Party shall cease and desist from further shipments of such Products in its possession or control until a decision by Client 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. "RECALL" As used herein, “Recall” shall mean any action (i) by the Client to recover title to or possession of quantities of the Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities Regulatory Authorities to detain or destroy any of the Products. Recall shall also include any action by either party Party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)