INTEC’s Compliance with API Specifications Sample Clauses

INTEC’s Compliance with API Specifications. INTEC represents and warrants that API delivered under this Agreement conforms to the API Specifications as set forth in Annex 5 and that it has been manufactured according to cGMP and all other applicable statutes, laws and regulations and is suitable and ready to be used for the Development Activities or the manufacture of Clinical Samples. Upon the successful transfer and validation of the methods LTS shall [***] all such API supplies intended for GMP-use according to the API Specifications set forth in Annex 5. In case that the API does not conform with the API Specifications INTEC shall promptly replace and deliver the necessary quantities of API to LTS. LTS shall bear the liability for conducting such testing of the API solely in the event of LTS’ willful misconduct and/or gross negligence. LTS shall bear the costs of replacement of such wrongly tested API used for Development Activities. In any case, LTS shall bear the expenses for investigating the root cause; all other liability shall be excluded. [***] = Information that has been omitted and submitted separately to the Securities and Exchange Commission and for which confidential treatment has been requested.
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Related to INTEC’s Compliance with API Specifications

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  • Lessee's Compliance with Applicable Requirements Except as otherwise provided in this Lease, Lessee shall, at Lessee's sole expense, fully, diligently and in a timely manner, materially comply with all Applicable Requirements, the requirements of any applicable fire insurance underwriter or rating bureau, and the recommendations of Lessor's engineers and/or consultants which relate in any manner to the Premises, without regard to whether said requirements are now in effect or become effective after the Start Date. Lessee shall, within ten (10) days after receipt of Lessor's written request, provide Lessor with copies of all permits and other documents, and other information evidencing Lessee's compliance with any Applicable Requirements specified by Lessor, and shall immediately upon receipt, notify Lessor in writing (with copies of any documents involved) of any threatened or actual claim, notice, citation, warning, complaint or report pertaining to or involving the failure of Lessee or the Premises to comply with any Applicable Requirements.

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  • Provide Data in Compliance with Applicable Laws LEA shall provide Student Data for the purposes of obtaining the Services in compliance with all applicable federal, state, and local privacy laws, rules, and regulations, all as may be amended from time to time.

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  • COMPLIANCE WITH LICENSING REQUIREMENTS CONTRACTOR shall comply with all necessary licensing requirements and shall obtain appropriate licenses and display the same in a location that is reasonably conspicuous, as well as file copies of same with the County Executive Office.

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