Common use of Inspection by Regulatory Authorities Clause in Contracts

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 4 contracts

Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.)

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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: Product Agreement (Galera Therapeutics, Inc.), Product Agreement (Amylyx Pharmaceuticals, Inc.), 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: Product Agreement (Osmotica Pharmaceuticals PLC), Product Agreement (Osmotica Pharmaceuticals LTD), Product Agreement (Osmotica Pharmaceuticals LTD)

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; provided, that Patheon shall perform such review within 21 days of receipt of the requested documents.

Appears in 3 contracts

Samples: Master Manufacturing Services Agreement, Product Agreement (Baudax Bio, Inc.), Product Agreement (Recro 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/), Product Agreement (Neurocrine Biosciences Inc)

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: Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke 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 3 contracts

Samples: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Raptor Pharmaceutical Corp), Manufacturing Services Agreement (Santarus 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 (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: Product Agreement (La Jolla Pharmaceutical Co), Product Agreement (Tetraphase 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 (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.), Product 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: Product Agreement (Jazz Pharmaceuticals PLC), Product Agreement (Jazz Pharmaceuticals PLC)

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 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)

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

Samples: Manufacturing Services Agreement (Egalet Corp)

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.. ***Confidential Treatment Requested

Appears in 1 contract

Samples: Manufacturing Services Agreement (Horizon Pharma PLC)

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 ***Confidential Treatment Requested Master Manufacturing Services Agreement documents that directly relate to the Manufacturing Services provided by Patheon and is satisfied with their contents.

Appears in 1 contract

Samples: Product Agreement (Acadia 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 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.. ***Confidential Treatment Requested Master Manufacturing Services Agreement

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

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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 8

Appears in 1 contract

Samples: Services Agreement

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

Samples: Manufacturing Services Agreement (Gentium S.p.A.)

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.. Standard Form

Appears in 1 contract

Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)

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: Product 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: Product Agreement (Horizon Therapeutics Public LTD Co)

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: Calliditas Therapeutics AB

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.. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED Standard Form (PPI, April 2, 2010)

Appears in 1 contract

Samples: 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 jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested Master Manufacturing Services Agreement documents that directly relate to the Manufacturing Services provided by Patheon and is satisfied with their contents.

Appears in 1 contract

Samples: Product Agreement (Acadia Pharmaceuticals Inc)

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 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 (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.. ***Confidential Treatment Requested Standard Form (PPI, April 2, 2010)

Appears in 1 contract

Samples: Manufacturing Services Agreement (Horizon Pharma PLC)

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