Common use of Records and Notice Clause in Contracts

Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any Products delivered to Client or customers of Client. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Products or which might result in the Recall or seizure of the Products. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of 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, will be made and implemented by Client. “Recall” will mean any action (i) by 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 will 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 3 contracts

Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Horizon Pharma PLC)

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Records and Notice. Patheon and Client The parties will each maintain records necessary to permit a Recall of any Products Product delivered to Client or customers of Client. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Products Product or which might result in the Recall or seizure of the ProductsProduct in accordance with the Quality Agreement. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Products 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. "Recall" will mean any action action: (i) by Client to recover title to or possession of quantities of the Products Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products Product from the market); or (ii) by any regulatory authorities Regulatory Authority to detain or destroy any of the Products. Recall will also include any action Product; or (iii) by either Party party to refrain from selling or shipping quantities of the Products Product to third parties which would have been be subject to a Recall if sold or shipped.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (PLx Pharma Inc.), Master Manufacturing Services Agreement (Savara Inc)

Records and Notice. Patheon and Client The parties will each maintain records necessary to permit a Recall of any Products Product delivered to Client or customers of Client. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Products Product or which might result in the Recall or seizure of the ProductsProduct in accordance with the Quality Agreement. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Products 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. “Recall” will mean any action action: (i) by Client to recover title to or possession of quantities of the Products Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products Product from the market); or (ii) by any regulatory authorities Regulatory Authority to detain or destroy any of the Products. Recall will also include any action Product; or (iii) by either Party party to refrain from selling or shipping quantities of the Products Product to third parties which would have been be subject to a Recall if sold or shipped.

Appears in 1 contract

Samples: Master Manufacturing Services Agreement (Amylyx Pharmaceuticals, Inc.)

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Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any Products delivered to Client or customers of Client. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Products or which might result in the Recall or seizure of the Products. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of 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, will be made and implemented by Client. "Recall" will mean any action (i) by 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 will 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 (Raptor Pharmaceutical Corp)

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