Encap Regulatory Obligations Sample Clauses

Encap Regulatory Obligations. Encap shall be responsible for and shall conduct all activities necessary for (i) maintaining approved regulatory status for commercial production and testing facilities including U.S. FDA and its equivalent in the Territory and other customary standards and paying all regulatory and license fees for its facilities, conducting Product support such as periodic audits, annual Product reviews, sample storage, batch documentation, audit reports, appropriate vendor qualification and other applicable regulatory requirements to supply Product to the Territory during the Term and following FDA approval of the Product; (ii) serving as the importer of record and import the API on Customer’s behalf and at Customer’s expense, including obtaining all permits and licenses required to import of raw materials and components, including API, and co-operating with Customer on the export of API for the development, manufacture, and delivery of pilot batches, pivotal batches, validation, and commercial batches of the Product, along with associated costs for the import permits or licenses; (iii) being prepared for an FDA pre-approval inspection within [***] working days of Application submission; and (iv) diligently sharing with Customer all regulatory communication pertaining to Product supply and quality. “Submission” shall be deemed to have occurred on the date that the Application is delivered to the FDA by Customer or its agent.
AutoNDA by SimpleDocs

Related to Encap Regulatory Obligations

  • Statutory Obligations Nothing in this Agreement shall be construed to modify, eliminate or detract from the statutory responsibilities and obligations of the Employer except that the exercise of its rights in the furtherance of such statutory obligations shall not be in conflict with the provisions of this Agreement.

  • Statutory Obligations and Regulations D1 Prevention of Corruption 19 D2 Prevention of Fraud 20 D3 Discrimination 21 D4 The Contracts (Rights of Third Parties) Act 1999 21 D5 Environmental Requirements 21 D6 Health and Safety 21

  • Developer Obligations In accordance with applicable NYISO requirements, Developer shall maintain satisfactory operating communications with Connecting Transmission Owner and NYISO. Developer shall provide standard voice line, dedicated voice line and facsimile communications at its Large Generating Facility control room or central dispatch facility through use of either the public telephone system, or a voice communications system that does not rely on the public telephone system. Developer shall also provide the dedicated data circuit(s) necessary to provide Developer data to Connecting Transmission Owner and NYISO as set forth in Appendix D hereto. The data circuit(s) shall extend from the Large Generating Facility to the location(s) specified by Connecting Transmission Owner and NYISO. Any required maintenance of such communications equipment shall be performed by Developer. Operational communications shall be activated and maintained under, but not be limited to, the following events: system paralleling or separation, scheduled and unscheduled shutdowns, equipment clearances, and hourly and daily load data.

  • Supplier Obligations 7.1 The Supplier shall: 7.1.1 at all times allocate sufficient resources to supply the Services in accordance with the Contract; 7.1.2 provide and fulfil any ancillary or incidental service, function or responsibility not specified in the Service Specification where such service, function or responsibility is necessary for the proper performance of the relevant Services; 7.1.3 obtain, and maintain throughout the duration of the Contract, all the consents, approvals, licences and permissions (statutory, regulatory, contractual or otherwise) it may require and which are necessary for the provision of the Services or performance of any other obligation under this Contract; 7.1.4 ensure the Supplier Assets used in the performance of the Services will be free of all encumbrances (except as agreed in writing with the Authority); 7.1.5 ensure that in the performance of its obligations under the Contract it does not disrupt the operations of each Commissioning Body and their respective Personnel; 7.1.6 ensure that any documentation, information and training provided to each Commissioning Body under this Contract (including in relation to the use of the Website) is comprehensive, accurate and prepared in accordance with Good Industry Practice; 7.1.7 co-operate with the Other Supplier(s) and provide reasonable information (including any documentation), advice and assistance in connection with the Services to the Other Supplier(s) including to enable such Other Supplier(s) to provide services to the respective Commissioning Bodies and, on the expiry or termination of this Contract for any reason, to enable the timely transition of the Services (or any of them) to the respective Commissioning Bodies and/or to any Replacement Supplier; 7.1.8 to the extent it is legally able to do so, hold on trust for the sole benefit of the Authority, all warranties and indemnities provided by third parties or any Sub- contractor in respect of any Deliverables and/or the Services and, where any such warranties are held on trust, at its cost enforce such warranties in accordance with any reasonable directions that the Authority may notify from time to time to the Supplier; 7.1.9 unless it is unable to do so, assign to the Authority on the Authority’s written request and at the cost of the Supplier any such warranties and/or indemnities as are referred to in Clause 7.1.8; 7.1.10 provide each Commissioning Body with such advice and assistance as that Commissioning Body may reasonably require during the Contract Period in respect of the supply of the Services; 7.1.11 gather, collate and provide such information and co-operation as the Authority may reasonably request for the purposes of ascertaining the Supplier’s compliance with its obligations under the Contract; 7.1.12 notify the Authority of any circumstances suggesting that a change of Control of the Supplier is planned, in contemplation or has taken place; 7.1.13 notify the Authority in writing of any material detrimental change in the financial standing and/or any change in the credit rating of the Supplier; 7.1.14 subject to Clause 33.6, notify the Authority in writing within ten (10) Working Days of their occurrence, of any actions, suits or proceedings or regulatory investigations before any court or administrative body or arbitration tribunal pending or, to its knowledge, threatened against it that might affect its ability to perform its obligations under the Contract; and 7.1.15 ensure that neither it, nor any of its Affiliates or Personnel, bring any Commissioning Body into disrepute by engaging in any act or omission which is reasonably likely to diminish the trust that the public places in that Commissioning Body, regardless of whether or not such act or omission is related to the Supplier’s obligations under this Contract.

  • Additional Statutory and Regulatory Obligations Vendor acknowledges that it has the following additional obligations under Section 2-d with respect to any Protected Data received from the District, and that any failure to fulfill one or more of these statutory or regulatory obligations will be deemed a breach of the Master Agreement and the terms of this Data Sharing and Confidentiality Agreement: (a) To limit internal access to Protected Data to only those employees or subcontractors that are determined to have legitimate educational interests within the meaning of Section 2-d and the Family Educational Rights and Privacy Act (FERPA); i.e., they need access in order to assist Vendor in fulfilling one or more of its obligations to the District under the Master Agreement. (b) To not use Protected Data for any purposes other than those explicitly authorized in this Data Sharing and Confidentiality Agreement and the Master Agreement to which this Exhibit is attached. (c) To not disclose any Protected Data to any other party, except for authorized representatives of Vendor using the information to carry out Vendor’s obligations to the District and in compliance with state and federal law, regulations and the terms of the Master Agreement, unless: (i) the parent or eligible student has provided prior written consent; or (ii) the disclosure is required by statute or court order and notice of the disclosure is provided to the District no later than the time of disclosure, unless such notice is expressly prohibited by the statute or court order. (d) To maintain reasonable administrative, technical, and physical safeguards to protect the security, confidentiality, and integrity of Protected Data in its custody. (e) To use encryption technology to protect Protected Data in its custody while in motion or at rest, using a technology or methodology specified by the Secretary of the U.S. Department of Health and Human Services in guidance issued under Section 13402(H)(2) of Public Law 111-5. (f) To adopt technologies, safeguards and practices that align with the NIST Cybersecurity Framework. (g) To comply with the District’s policy on data security and privacy, Section 2-d and Part 121. (h) To not sell Protected Data nor use or disclose it for any marketing or commercial purpose or facilitate its use or disclosure by any other party for any marketing or commercial purpose or permit another party to do so. (i) To notify the District, in accordance with the provisions of Section 5 of this Data Sharing and Confidentiality Agreement, of any breach of security resulting in an unauthorized release of Protected Data by Vendor or its assignees or subcontractors in violation of applicable state or federal law, the District’s Bill of Rights for Data Security and Privacy, the District’s policies on data security and privacy, or other binding obligations relating to data privacy and security contained in the Master Agreement and this Exhibit. (j) To cooperate with the District and law enforcement to protect the integrity of investigations into the breach or unauthorized release of Protected Data. (k) To pay for or promptly reimburse the District for the full cost of notification, in the event the District is required under Section 2-d to notify affected parents, students, teachers or principals of a breach or unauthorized release of Protected Data attributed to Vendor or its subcontractors or assignees.

  • Third Party Obligations 3.1. The THIRD PARTY shall:- 3.1.1. not divulge the Confidential Information to any party other than as provided for in this Confidentiality Agreement; 3.1.2. use the Confidential Information only for the purposes necessary in providing the services for which he is engaged by the AUTHORITY; and 3.1.3. make no commercial use of the Confidential Information or any part thereof. 3.2. Notwithstanding the foregoing, the THIRD PARTY shall be entitled to make any disclosure required by law of the Confidential Information and shall notify the AUTHORITY of so doing in accordance with the provisions of paragraph 6.

  • Contractor Obligations After receipt of the Notice of Termination and except as otherwise directed by the State, the Contractor shall immediately proceed to: a. To the extent specified in the Notice of Termination, stop work under the Contract on the date specified. b. Place no further orders or subcontracts for materials, services, and/or facilities except as may be necessary for completion of such portion(s) of the work under the Contract as is (are) not terminated. c. Terminate and cancel any orders or subcontracts for related to the services, except as may be necessary for completion of such portion(s) of the work under the Contract as is (are) not terminated. d. Transfer to the State all completed or partially completed plans, drawings, information, and other property which, if the Contract had been completed, would be required to be furnished to the State. e. Take other action as may be necessary or as directed by the State for the protection and preservation of the property related to the contract which is in the possession of the contractor and in which the State has or may acquire any interest. f. Make available to the State all cost and other records relevant to a determination of an equitable settlement.

  • USER OBLIGATIONS As a user of the Website or Services, You may be asked to register with Us. When You do so, You will choose a user identifier, which may be Your email address or another term, as well as a password. You may also provide personal information, including, but not limited to, Your name. You are responsible for ensuring the accuracy of this information. This identifying information will enable You to use the Website and Services. You must not share such identifying information with any third party, and if You discover that Your identifying information has been compromised, You agree to notify Us immediately in writing. Email notification will suffice. You are responsible for maintaining the safety and security of Your identifying information as well as keeping Us apprised of any changes to Your identifying information. Providing false or inaccurate information, or using the Website or Services to further fraud or unlawful activity is grounds for immediate termination of this Agreement.

  • Provider Obligations A. PROVIDER will perform the Services in accordance with the standards of care, skill, and diligence expected of a qualified, competent and experienced professional in the provision of the type of services required under this Agreement. B. PROVIDER will obtain, maintain in effect, and pay the cost for all licenses, permits, or certifications that may be necessary for PROVIDER’s performance of this Agreement. C. PROVIDER represents and warrants that there are no obligations, commitments, third party rights, or impediments of any kind that will limit or prevent PROVIDER’s performance of the Services.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!