Notification Due to Regulatory Obligation Sample Clauses

Notification Due to Regulatory Obligation. Notwithstanding any other term of this Agreement, if any other Antibody being developed by Celltech is [*] by a Regulatory Authority for reasons which Celltech believes are attributable to [*] rather than to [*], Celltech shall notify Amgen of this as soon as reasonably practicable after receipt of written notice of [*] from the Regulatory Authority.
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Related to Notification Due to Regulatory Obligation

  • 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.

  • Settlement without Consent if Failure to Reimburse If at any time an indemnified party shall have requested an indemnifying party to reimburse the indemnified party for fees and expenses of counsel, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by Section 6(a)(ii) effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the aforesaid request, (ii) such indemnifying party shall have received notice of the terms of such settlement at least 30 days prior to such settlement being entered into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.

  • 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

  • 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.

  • Termination Due to Force Majeure Event If the period of Force Majeure continues or is in the reasonable judgment of the Parties likely to continue beyond a period of 120 (one hundred and twenty) Days, the Parties may mutually decide to terminate this Agreement or continue this Agreement on mutually agreed revised terms. If the Parties are unable to reach an agreement in this regard, the Affected Party shall after the expiry of the said period of 120 (one hundred and twenty ) Days be entitled to terminate the Agreement in which event, the provisions of Articles 16 and 17 shall, to the extent expressly made applicable, apply.

  • Termination due to Force Majeure 13.5.1 If the Force Majeure Event or its effects continue to be present beyond the period as specified in Article 4.5.3, either Party shall have the right to cause termination of the Agreement. In such an event, this Agreement shall terminate on the date of such Termination Notice.

  • Stipulated Penalties for Failure to Comply with Certain Obligations As a contractual remedy, the Friendship Entities and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day the Friendship Entities fail to establish and implement any of the following obligations as described in Sections III and IV: a. a Compliance Officer; b. a Compliance Committee; c. the Board of Directors compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review and the preparation of a Compliance Program Review Report, as required by Section III.A.3.; d. the management certification obligations; e. a written Code of Conduct; f. written Policies and Procedures; g. the development and/or implementation of a Training Plan for the training of Covered Persons, Relevant Covered Persons, and Board Members; h. a risk assessment and internal review process as required by Section III.E; i. a Disclosure Program; j. Ineligible Persons screening and removal requirements; k. notification of Government investigations or legal proceedings; l. policies and procedures regarding the repayment of Overpayments; m. the repayment of Overpayments as required by Section III.I and Appendix B; n. reporting of Reportable Events; and o. disclosure of changes to business units or locations. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day the Friendship Entities fail to engage and use an IRO, as required by Section III.D, Appendix A, or Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day the Friendship Entities fail to submit the Implementation Report or any Annual Reports to OIG in accordance with the requirements of Section V by the deadlines for submission. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day the Friendship Entities fail to submit any Claims Review or Additional Items Review Report in accordance with the requirements of Section III.D and Appendix B. 5. A Stipulated Penalty of $1,500 for each day the Friendship Entities fail to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date the Friendship Entities fail to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of the Friendship Entities as part of their Implementation Report, any Annual Report, additional documentation to a report (as requested by the OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $1,000 for each day the Friendship Entities fail to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to the Friendship Entities stating the specific grounds for its determination that the Friendship Entities have failed to comply fully and adequately with the CIA obligation(s) at issue and steps the Friendship Entities shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 days after the date the Friendship Entities receive this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 6 of this Section.

  • Payment of Sales, Use or Similar Taxes All sales, use, transfer, intangible, recordation, documentary stamp or similar Taxes or charges, of any nature whatsoever, applicable to, or resulting from, the transactions contemplated by this Agreement shall be borne by the Sellers.

  • Obligation to Suspend Distribution Upon receipt of any notice from the Company of the happening of any event of the kind described in Section 3.1.4(iv), or, in the case of a resale registration on Form S-3 pursuant to Section 2.3 hereof, upon any suspension by the Company, pursuant to a written xxxxxxx xxxxxxx compliance program adopted by the Company’s Board of Directors, of the ability of all “insiders” covered by such program to transact in the Company’s securities because of the existence of material non-public information, each holder of Registrable Securities included in any registration shall immediately discontinue disposition of such Registrable Securities pursuant to the Registration Statement covering such Registrable Securities until such holder receives the supplemented or amended prospectus contemplated by Section 3.1.4(iv) or the restriction on the ability of “insiders” to transact in the Company’s securities is removed, as applicable, and, if so directed by the Company, each such holder will deliver to the Company all copies, other than permanent file copies then in such holder’s possession, of the most recent prospectus covering such Registrable Securities at the time of receipt of such notice.

  • Failure to Make Payment In the event a participating Authorized User fails to make payment to the Contractor for Products delivered, accepted and properly invoiced, within thirty calendar days of such delivery and acceptance, the Contractor may, upon five business days advance written notice to both the Commissioner and the Authorized User’s purchasing official, suspend additional shipments of Product or provision of services to such entity until such time as reasonable arrangements have been made and assurances given by such entity for current and future Contract payments.

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