Outsourced Activities Clause Samples

Outsourced Activities. Sometimes we may ask other companies or people to do typing, printing, copying, IT support or other work on our files or data to ensure this is done promptly and cost-effectively. We will always seek a confidentiality agreement with these outsourced providers.

Outsourced Activities. In the event the Research Plan provides, or the JRC agrees, work under the Research Program may be conducted by a Third Party. Unless otherwise agreed by the Parties, Biogen Idec shall bear the out-of-pocket costs incurred with respect to such work.

Outsourced Activities the customer confirms that any activity which is outsourced beyond their immediate company should be correctly defined, agreed and controlled under a written agreement, in accordance with National Competent Authority.

Outsourced Activities locations shown in the Specification to the Schedule and identified as owned or occupied by the suppliers of outsourced services. This policy shall not indemnify the Insured arising from ▪ any contractual remedy or future

Outsourced Activities. Notification of any outsourced activities, for example: QC Laboratory Testing, Stability Testing. Cleaning, Calibration / maintenance Uniforms supply, Waste disposal. Packaging activities Warehousing Pharmacovigilance Irradiation Approval for the contract acceptor to sub-contract to a third party any of the work entrusted under this agreement Confirmation of appropriate licensing/certification of the contract acceptor Confirmation written commercial contracts are in place and GMP agreements where appropriate Qualification of contracted manufacturers that conduct a step in the bulk manufacture of the medicine (including licensing and or certifications) Qualification of contracted manufacturers that conduct a packaging step (including licensing and or certifications) Qualification of contracted laboratories that conduct analytical testing (including licensing and or certifications) Qualification of contracted warehousing (including licensing and or certifications) Qualification of contracted transport where temperature control is necessary Oversight and inspection of outsourced activity providers Handling and secure disposal of waste arising from manufacture of the products (including samples, printed packaging components and rejected semi-finished or finished product) to be carried out in accordance with documented methods compliant with relevant Environmental and Health & Safety legislation Maintenance of a manifest of securely disposed items Approval of outsourced providers and update to Appendix 1 Notification of any change to outsource provider Notification to the Contract Giver of Critical or Major deficiencies identified by Inspection Agencies relating to any manufacturers involved in the supply chain within <an agreed timeframe> Investigation of the deficiencies identified to determine impact on product compliance subject to this agreement Risk assessment and identification of any batches impacted Provision of Risk Assessment Report to the Contract Giver Notification of regulatory compliance (APIs) Notification to National Regulatory Agency/Agencies Provision of records of traceability of all units of each batch manufactured stored and distributed as necessary Provision of review all quality-related returns, complaints and recalls and the investigations performed at the time Provision of review of post marketing commitments to new marketing authorisations and variations to marketing authorisations Provision of review the Marketing Authorisation varia...

Outsourced Activities. RESPONSIBILITY 15.1 Maintain responsibility for packaging activities sub-contracted to third parties. X 15.2 Ensure that the use of a packaging sub-contractor does not happen without receiving prior approval in writing from INDV. X 15.3 Ensure sub-contractors used for contracted packaging services hold the necessary authorization(s), where applicable. X lndivior-Sharp, Technical Agreement, Version 8.0 Page 21 of 29 TECHNICAL AGREEMENT Reference Number: CQTA041 I Version Number: 9.0 15.4 Ensure a supplementary technical agreement with each packaging sub­ contractor so that that each party is clear as to their obligations regarding the Product(s), ensuring it is aligned with this agreement and local regulatory requirements. X

Outsourced Activities. ‌ locations shown in the Specification to the Schedule and identified as owned or occupied by the suppliers of outsourced services. This policy shall not indemnify the Insured arising from ▪ any contractual remedy or future discounts or savings allowed in the costs for the outsourced services ▪ any costs associated with the change in the nature or extent of the outsourced services ▪ any additional costs in transferring outsourced services to another supplier if the contract is scheduled to expire within the indemnity period ▪ any damage caused or resulting from earthquake, windstorm or flood outside of the United Kingdom For the purposes of 4 above, the amount payable under this extension shall be the sale value of all products of the Insured which cannot be produced or sold in consequence of the enforcement action, less: ▪ any sum saved in respect of such of the charges and expenses of the Insured’s business as may cease or be reduced in consequence of the enforcement action, and ▪ any sum payable to the insured as compensation under the terms of the Food Safety Act or otherwise. The amount payable will be reduced by any sum saved in respect of such of the charges and expenses of the Insured’s business as may cease or be reduced in consequence of the enforcement action and any amount awarded as compensation within the terms of United Kingdom legislation.

Outsourced Activities. In the event the Research Plan provides, or the JRC agrees, that work under the Research Program is to be conducted by a Third Party, unless otherwise agreed by the Parties, Merck shall bear the out-of-pocket costs incurred with respect to such work that is approved in advance by Merck.