Common use of Recalls Clause in Contracts

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 8 contracts

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

Sources: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals 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

Sources: Master Manufacturing Services Agreement (Calliditas Therapeutics AB), Master Manufacturing Services Agreement (Amylyx Pharmaceuticals, Inc.), Manufacturing 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

Sources: Master Manufacturing Services 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

Sources: Master Commercial Manufacturing Services Agreement (INSMED Inc), Master Manufacturing Services Agreement (Galera Therapeutics, Inc.), Master Manufacturing Services Agreement (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 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

Sources: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke 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 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

Sources: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC), Manufacturing Services Agreement, Master Manufacturing Services Agreement (Jazz Pharmaceuticals 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 cGMPs and regulationsApplicable Laws.

Appears in 2 contracts

Sources: Master Manufacturing Services Agreement (Paratek Pharmaceuticals, Inc.), Master Manufacturing Services 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

Sources: 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

Sources: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Manufacturing Services Agreement (Optimer 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

Sources: Master Manufacturing Services 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

Sources: Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz 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

Sources: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Master 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 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

Sources: 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

Sources: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia 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 regulations.Applicable Laws. ​ ​ ​ ​ ​ ​

Appears in 1 contract

Sources: Manufacturing Services Agreement (Ardelyx, 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 in all such actions and efforts as reasonably required by Client, having regard to all applicable laws and regulationsApplicable Laws.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (Cara Therapeutics, 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

Sources: Manufacturing Services Agreement (Egalet 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 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

Sources: 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

Sources: Manufacturing Services Agreement (Acura 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 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

Sources: 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

Sources: Manufacturing Services Agreement (Keryx Biopharmaceuticals 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

Sources: Manufacturing Agreement (Vanda 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

Sources: Manufacturing Services Agreement (Nabriva Therapeutics 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 regulations.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (ChemoCentryx, 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

Sources: 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

Sources: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)

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

Sources: Commercial Manufacturing Services Agreement (Clinical Data 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

Sources: Manufacturing Services Agreement (New River 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 regulationsApplicable Laws.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Pozen Inc /Nc)

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

Sources: Supply Agreement (Akebia Therapeutics, 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

Sources: Manufacturing Services Agreement (Acorda 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

Sources: 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 Applicable Laws and regulations.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (Neurocrine Biosciences 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 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

Sources: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)

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

Sources: 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 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

Sources: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)