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 (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 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 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 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 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 cGMPs and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Paratek Pharmaceuticals, Inc.), Product Agreement (Paratek 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 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 (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 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 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 and regulationsApplicable Laws.
Appears in 2 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia 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 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 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 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 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 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 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 (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 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 (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 (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 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 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)
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 (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 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 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 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 (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) 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 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 (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 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 (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 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)