Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any Product delivered to Client or customers of Client. Each Party will 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 or which might result in the Recall or seizure of the Product. Upon receiving this notice or upon this discovery, each Party will stop making any further shipments of any 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, will be made and implemented by Client in its sole discretion. “Recall” will mean any action (i) by 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); (ii) by any Regulatory Authorities to detain or destroy any of the Product; or (iii) by either Party to refrain from selling or shipping quantities of the Product to third parties which would be subject to an action described in clause (i) or (ii) of this sentence if sold or shipped.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.), Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.)
Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any Product Products delivered to Client or customers of Client. Each Party party will 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 Products or which might result in the Recall or seizure of the ProductProducts. Upon receiving this notice or upon this discovery, each Party party will stop making any further shipments of any Product applicable Product(s) 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, will be made and implemented by Client in its sole discretionClient. “"Recall” " will mean any action (i) by 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 Product; or (iii) Products. Recall will also include any action by either Party party to refrain from selling or shipping quantities of the Product Products to third parties which would be subject to an action described in clause (i) or (ii) of this sentence a Recall if sold or shipped.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)
Records and Notice. Patheon and Client The parties will each maintain records necessary to permit a Recall recall of any Product delivered to Client or customers of Client. Each Party party will promptly notify the other by telephone (to be confirmed in writing) party of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the ProductProduct in accordance with the Quality Agreement. Upon receiving this notice or upon this discovery, each Party party will stop making any further shipments of any 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, will be made and implemented by Client in its sole discretion. “Recall” will mean any action action: (i) by 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); (ii) by any Regulatory Authorities Authority to detain or destroy any of the Product; or (iii) by either Party party to refrain from selling or shipping quantities of the Product to third parties which would be subject to an action described in clause (i) or (ii) of this sentence a Recall if sold or shipped.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Calliditas Therapeutics AB)
Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any Product Products delivered to Client or customers of Client. Each Party party will 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 or Products and/or which might result in the Recall or seizure of the ProductProducts. Upon receiving this any such notice or upon this any such discovery, each Party party will stop making any cease and desist from further shipments of any 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, will be made and implemented by Client in its sole discretionClient. “"Recall” " will mean any action (i) by 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; or (iii) Products. Recall will also include any action by either Party to refrain from selling or shipping quantities of the Product Products, to third parties parties, which would be have been subject to an action described in clause (i) or (ii) of this sentence a Recall if sold or shipped.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)