Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 5 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority regulatory authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority regulatory authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 4 contracts
Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.), Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Raptor Pharmaceutical Corp)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above this Section 7.5 or the Quality Agreement within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents. Client’s breach of this requirement will be considered a material breach of this Agreement.
Appears in 4 contracts
Samples: Master Manufacturing Services Agreement (Galera Therapeutics, Inc.), Master Manufacturing Services Agreement (Amylyx Pharmaceuticals, Inc.), Manufacturing Services Agreement (PLx Pharma Inc.)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretiondiscretion after giving written notice to Client, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause subsection (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Nabriva Therapeutics PLC), Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/), Master Manufacturing Services Agreement (Neurocrine Biosciences Inc)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents that directly relate to the Manufacturing Services provided by Patheon and is satisfied with their contents.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc), Master Manufacturing Services Agreement (Acadia Pharmaceuticals Inc)
Inspection by Regulatory Authorities. If Client Indivior does not give Patheon the documents requested under clause subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon (i) shall so notify Client in writing and (ii) may, in its sole discretion, upon written notice to Client, delay or postpone any inspection by the Regulatory Authority with respect to the Product that is the subject of such documents until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority regulatory authority may be jeopardized, Patheon may, in its sole discretion, . delay or postpone any inspection by the Regulatory Authority regulatory authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b7.7(b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Master Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause clauses (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents, but this review must be completed within [*] days of Patheon’s receipt of the documentation from Client.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC), Master Manufacturing Services Agreement (Jazz Pharmaceuticals PLC)
Inspection by Regulatory Authorities. If Client does not give Patheon the necessary documents requested under clause (b) above within this Section 7.5 or the time specified Quality Agreement and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretionfollowing good faith discussion with Client, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Calliditas Therapeutics AB)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause Paragraph (b) above within the time specified and if Patheon reasonably believes that this Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardizedjeopardized as a result, Patheon may, in its sole discretion, may delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s 's standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardizedJeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause subsection (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s 's standing with a Regulatory Authority regulatory authority may be jeopardized, Patheon may, in its sole discretion, . delay or postpone any inspection by the Regulatory Authority regulatory authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Inspection by Regulatory Authorities. If Client does not give provide Patheon with the documents documentation requested under clause paragraph (b) above within the time specified stipulated in these paragraphs and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority the regulatory authorities may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority regulatory authorities until such time Patheon has reviewed the requested documents documentation and is satisfied with their its contents.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Zymogenetics Inc)
Inspection by Regulatory Authorities. If Client Customer does not give provide Patheon with the documents requested under clause pursuant to paragraph (b) above within the time specified stipulated in these paragraphs and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority regulatory authority may be jeopardized, Patheon may, in its sole discretion, but only to the extent that is reasonable, delay or postpone any inspection by the Regulatory Authority regulatory authority until such time as Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause clauses (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents., but this review must be completed within [*] days of Patheon’s receipt of the documentation from Client. ARTICLE
Appears in 1 contract
Samples: Manufacturing Services Agreement
Inspection by Regulatory Authorities. If Client Penwest does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)