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.
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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.

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  • 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 (a) Supplier shall not access (including remote access), copy, use or other process any Personal Information to be less than expressly necessary for the provision of the services subject to this Purchase Order. Supplier will ensure that the Supplier that all its obligations in relation to the processing of Personal Information by force of this Purchase Order are applied employees and representatives. (b) Supplier shall process the Data from the Novartis on your behalf only through the novartis' express instructions and will process such data exclusively for the purposes set out in this Purchase Order and in the form necessary for the implementation of the services contracted herein. (c) Where supplier is obliged to disclose any Personal Information and/or Personal Information Novartis obtained under this purchase order, due to the request for competent authority, it shall communicate immediately to Novartis on this request and always get your consent to any disclosure. (d) Supplier shall ensure strict confidentiality of Novartis Data and/or Personal Information to which you have had access during the execution of the services now contracted and not transmit or otherwise disclose this Data and/or Personal Information to third parties. (e) Supplier may not subcontract or transfer to third parties the rights and obligations assumed through this Purchase Order without the prior written consent of the Novartis. Novartis will authorize the subcontracting or transfer only if the Supplier to establish with the subcontractor a written agreement by assigning to the subcontractor the rights and obligations assigned to it, under this Purchase Order. No notwithstanding the foregoing, the Supplier will remain fully responsible for the fulfillment of its obligations and the subcontractor, under this Purchase Order. (f) Supplier shall comply with all obligations relating to the Data Security of the Novartis and/or Personal Information to which have access, equivalent to those imposed on the Novartis, and shall adopt and implement all technical and organizational measures to adequately protect Novartis Data against any change, use and disclosure not accidental loss or destruction or illegal. (g) Supplier shall, upon Novartis request or at the end of this Purchase Order, destroy or return to Novartis all Personal Information and/or Personal Data of Novartis collected, stored and processed in the scope of this Purchase Order as well as all materials or documents generated or used by supplier in the execution of the services subject to this Purchase Order information in which there is any information Novartis' ownership. (h) Supplier shall inform Novartis immediately about any breakage or failure security or privacy of Novartis Data and/or Personal Information and supplier must cooperate with Novartis in the solution of such failures, including data recovery or any other form of remediation. (i) Supplier shall indemnify Novartis for any loss, damage, or complaint arising out of or arising from the non-compliance obligations assumed under this Purchase Order related to processing or implementation of technical and safety measures related to collection, storage and processing of data Novartis and/or Personal Information related to this Purchase Order.

  • 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.