Common use of Deficiencies Clause in Contracts

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 3 contracts

Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Product Agreement (Keryx Biopharmaceuticals Inc), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)

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Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies within [***] Business Days of Patheon becoming aware of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspectioninspection by a Regulatory Authority.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)

Deficiencies. If, in Patheon’s sole good faith discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 2 contracts

Samples: Product Agreement (Jazz Pharmaceuticals PLC), Product Agreement (Jazz Pharmaceuticals PLC)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client Indivior under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client Indivior promptly in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 2 contracts

Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever material respect (the "Deficiencies"), Patheon will notify Client in writing of the DeficienciesDeficiencies as promptly as practical and in any case within the time frame set forth in clause (b) or (c), as applicable. The parties Parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 2 contracts

Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 2 contracts

Samples: Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties Parties will work together in good faith to have the any Deficiencies resolved prior to the date of filing of the relevant application and in any pre-approval inspectionevent before any PAI or before the Product is placed on the market if a PAI is not performed.

Appears in 2 contracts

Samples: Product Agreement (Paratek Pharmaceuticals, Inc.), Product Agreement (Paratek Pharmaceuticals, Inc.)

Deficiencies. If, in Patheon’s 's sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 1 contract

Samples: Product Agreement (Horizon Therapeutics Public LTD Co)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that this any of the information given by Client under clauses Paragraphs (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the such Deficiencies. The parties will work together to have the such Deficiencies resolved prior to any pre-approval inspection.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)

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Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any a material manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspectionsubmission of the information to a Regulatory Authority.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Pozen Inc /Nc)

Deficiencies. If, in Patheon’s 's sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Egalet Corp)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Synageva Biopharma Corp)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever material respect (the "Deficiencies"), Patheon will notify Client in writing of the DeficienciesDeficiencies as promptly as practical and in any case within the time frame set forth in clause (b) or (c), as applicable. The parties Parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

Deficiencies. If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses clause (b) and (c) above is materially inaccurate or deficient in any manner whatsoever (the "Deficiencies"), Patheon will notify Client in writing of the DeficienciesDeficiencies within 24 hours of discovery of such Deficiencies by Patheon, but in any case, within the time limit set forth in clause (b) above. The parties will work together to have the Deficiencies resolved prior to any filing or pre-approval inspection, as applicable.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)

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