Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 9 contracts
Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Product Agreement (La Jolla Pharmaceutical Co), Product Agreement (Osmotica Pharmaceuticals PLC)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authorityregulatory authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority regulatory authorities and any relevant costs will be borne by the Client.
Appears in 6 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)
Client Responsibility. For clarity, the parties agree that in In reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 4 contracts
Samples: Product Agreement (ChemoCentryx, Inc.), Manufacturing Services Agreement (Nabriva Therapeutics PLC), Product Agreement (Paratek Pharmaceuticals, Inc.)
Client Responsibility. For clarity, the parties Parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 3 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause subsections (b) and (c) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client, excepts as otherwise provided in this Section 7.8.
Appears in 3 contracts
Samples: Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application Application for receipt of an approval by a Regulatory AuthorityMarketing Authorization. The Client is solely responsible responsibility for the preparation and filing of the application Application for approval by the Regulatory Authority Marketing Authorization, and any relevant costs will be borne by the Client.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority Authorities and any relevant costs will be borne by the Client.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Pozen Inc /Nc), Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)
Client Responsibility. For clarity, the The parties agree that that, in reviewing the documents referred to in clause clauses (b) and (c) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement, Product Agreement (Recro Pharma, Inc.)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s 's role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authorityregulatory authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority regulatory authorities and any relevant costs will be borne by the Client.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) and (c) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 1 contract
Samples: Product Agreement (TESARO, Inc.)
Client Responsibility. For clarity, the parties Parties agree that in reviewing the documents referred to in clause paragraph (b) above, Patheon’s role will be limited to verifying the accuracy of the description of information relevant to the work undertaken or to be undertaken by Patheon. Subject to the foregoingAs such, Patheon will shall not assume any responsibility for the accuracy of any application for the receipt of an approval by a Regulatory Authoritythe regulatory authorities. The Client is solely responsible for sole responsibility of the preparation (included without limitation, drafting of regulatory filings) and filing of the application for the receipt of approval by the Regulatory Authority regulatory authorities and any relevant costs will shall be borne by the Client.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Zymogenetics Inc)
Client Responsibility. For clarity, the parties agree that this in reviewing the documents referred to in clause Paragraph (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority Authorities and any relevant costs will be borne by the Client.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acorda Therapeutics Inc)
Client Responsibility. For clarity, the parties agree that in In reviewing the documents referred to in clause (bSection 7.8(b) above, Patheon’s role will be limited to verifying the accuracy of the data generated by Patheon and the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause subsections (b) and (c) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application by Client for receipt of an approval by a Regulatory Authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority Authorities and any relevant costs will be borne by the Client, except as otherwise provided in this Section 7.8.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) } above, Patheon’s 's role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible responsibility for the preparation and filing of the application for approval by the Regulatory Authority Authorities and any relevant costs will be borne by the Client.
Appears in 1 contract
Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s 's role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.
Appears in 1 contract
Samples: Product Agreement (Horizon Therapeutics Public LTD Co)