Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for 100% of its own, and all third party, expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 3 contracts
Samples: Commercial Supply Agreement, Commercial Supply Agreement (Kala Pharmaceuticals, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)
Client and Third Party Expenses. Except as may be expressly covered by the Product Maintenance Service feesFee for Processing and the Product Maintenance Fee for Packaging, Client shall be responsible for 100% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 3 contracts
Samples: And Packaging Agreement, Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.), Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, as between the parties hereto, Client shall be responsible for 100% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Lexicon Pharmaceuticals, Inc.), Commercial Supply Agreement (Lexicon Pharmaceuticals, Inc.)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees[*], Client shall be responsible for 100[*]% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 2 contracts
Samples: Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD), Commercial Manufacturing Agreement (Salix Pharmaceuticals LTD)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for one hundred percent (100% %) of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals Approval and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 2 contracts
Samples: Supply Agreement (Avadel Pharmaceuticals PLC), Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service feesfees set forth in Section 7.1.C above, Client shall be responsible for 100[ * ]% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 2 contracts
Samples: Quality Agreement, Quality Agreement (Intermune Inc)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for 100% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.. 7.7
Appears in 1 contract
Samples: Supply Agreement
Client and Third Party Expenses. Except as may be expressly covered by the Product Maintenance Service feesFee for Processing and the Product Maintenance Fee for Packaging, Client shall be responsible for 100% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.. *** Confidential Treatment Requested
Appears in 1 contract
Samples: Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, as between the parties hereto, Client shall be responsible for one hundred percent (100% %) of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, obtaining Regulatory Approvals for the Product (other than any Facility Approvals) and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 1 contract
Samples: And Packaging Agreement (Vivus Inc)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for 100% of [redacted]of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 1 contract
Samples: Softgel Commercial Supply Agreement (Aurinia Pharmaceuticals Inc.)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for 100% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals Approval and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 1 contract
Samples: Zydis® Commercial Supply Agreement (Biohaven Pharmaceutical Holding Co Ltd.)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service fees, Client shall be responsible for 100% of its own, own and all third party, Third Party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Product, including regulatory filings and post-approval marketing studies.
Appears in 1 contract
Samples: Build Out and Commercial Supply Agreement (Pharmacyclics Inc)
Client and Third Party Expenses. Except as may be expressly covered by Product Maintenance Service feesServices, Client shall be responsible for 100[***]% of its own, own and all third party, third-party expenses incurred by Client outside the scope of this Agreement which are associated with the development, Regulatory Approvals and commercialization of Client Product, including regulatory filings and post-approval marketing studies.
Appears in 1 contract
