Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 5 contracts
Samples: Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.), Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)
Recalls. If If: (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, ; (ii) a court of competent jurisdiction orders a Recall, ; or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 3 contracts
Samples: Calliditas Therapeutics AB, Product Agreement (Amylyx Pharmaceuticals, Inc.), Services Agreement (PLx Pharma Inc.)
Recalls. If (i) any governmental or regulatory authority Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 3 contracts
Samples: Product Agreement (Jaguar Animal Health, Inc.), Master Manufacturing Services Agreement (Jaguar Animal Health, Inc.), Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate cooperate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 3 contracts
Samples: Product Agreement (Osmotica Pharmaceuticals PLC), Product Agreement (Osmotica Pharmaceuticals LTD), Product Agreement (Osmotica Pharmaceuticals LTD)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a the Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 3 contracts
Samples: Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc)
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating to the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Recalls. If If: (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, ; (ii) a court of competent jurisdiction orders a Recall, ; or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Galera Therapeutics, Inc.), Savara Inc
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc)
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the Client determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by the Client, having regard to all applicable laws and regulationsLaws.
Appears in 2 contracts
Samples: Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 2 contracts
Samples: Product Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client Indivior determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by ClientIndivior, having regard to all applicable laws and regulations.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Product Agreement (Keryx Biopharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws cGMPs and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Paratek Pharmaceuticals, Inc.), Product Agreement (Paratek Pharmaceuticals, Inc.)
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalledrecalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) Client New River determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by ClientNew River or its designee, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (New River Pharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 1 contract
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client Supernus determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating to the restrictions on the use of any Product, Patheon Supplier will co-operate as reasonably required by ClientSupernus, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Commercial Supply Agreement (Supernus Pharmaceuticals Inc)
Recalls. If (i) any governmental Authority or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws Applicable Laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) Client **** determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating to the restrictions on the use of any Product, Patheon will co-operate as reasonably required by the Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the Client determines that any Product should be Recalled or that a “Dear Doctor” "dear doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by the Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc)
Recalls. If (i) any governmental or regulatory authority Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acura Pharmaceuticals, Inc)
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.. ***Confidential Treatment Requested
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Recalls. If (iI) any governmental or regulatory authority issues Issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iiiIll) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is Is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or Master Manufacturing Services Agreement that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Recalls. If If: (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, ; (ii) a court of competent jurisdiction orders a Recall, ; or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, then Patheon will co-operate in all such actions and efforts as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 1 contract
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) Client Avanir determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by ClientAvanir, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Avanir Pharmaceuticals)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws Applicable Laws and regulations.
Appears in 1 contract
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) Client Éclat determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by ClientÉclat, having regard to all applicable laws and regulations.
Appears in 1 contract
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client CUSTOMER determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon NPI will co-operate as reasonably required by ClientCUSTOMER, having regard to in accordance with all applicable laws Applicable Laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client PGx determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by ClientPGx, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Clinical Data Inc)
Recalls. If In the event (i) any governmental or regulatory authority Authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the Client determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required requested by the Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Somaxon Pharmaceuticals, Inc.)
Recalls. If If: (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) Client **** determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating to the restrictions on the use of any Product, Patheon **** will co-operate as reasonably required by Client****, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)
Recalls. If If: (i) any governmental or regulatory authority Regulatory Authority issues a directive, order order, or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, ; (ii) a court of competent jurisdiction orders a Recall, ; or (iii) Client determines that any Product should be Recalled or that a “"Dear Doctor” " letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to in compliance with all applicable laws and regulationsApplicable Laws.
Appears in 1 contract
Samples: Akebia Therapeutics, Inc.
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate cooperate as reasonably required by Client, having regard to all applicable laws Applicable Laws and regulations.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Recalls. If In the event (i) any governmental or regulatory authority issues a directive, order or, following the issuance of a safety warning or alert about with respect to a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders such a Recall, or (iii) the Client determines that any Product should be Recalled or that a “Dear Doctordear doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by the Client, having regard to all applicable laws and regulationsApplicable Laws.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)
Recalls. If (i) any governmental or regulatory authority Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a the Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Nabriva Therapeutics PLC)