Damages for Regulatory Failures Sample Clauses

Damages for Regulatory Failures. If FFFC fails to deliver on a timely basis API ordered by Cempra under this Agreement due to either: (i) failure of FFFC to obtain or maintain all needed Facilities Licenses or (ii) a determination by the MHLW or any other Regulatory Authority that the API is “misbranded or adulterated” within the meaning of the FD&C Act (or equivalent determination under any Applicable Law in the Territory) due to any manufacturing problem or issue at the Facility, or any other similar disability or determination raised, imposed, or made by a Regulatory Authority, each arising from any reason, act, or omission attributable to FFFC, its Affiliates, or its subcontractors, then FFFC shall indemnify and hold Cempra harmless from any and all losses resulting from lost sales caused directly by such failure to deliver within the limitation set forth in Section 12.4.
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Damages for Regulatory Failures. If Lonza fails to deliver on a timely basis Bulk Product Component ordered by Altus under this Agreement due to either: (i) failure of Lonza to obtain or maintain all needed Facilities Licenses; or (ii) a determination by the FDA that the Bulk Product Component is "misbranded or adulterated" within the meaning of the FD&C Act due to any manufacturing problem or issue at the Lonza Facility, or any other similar disability raised or imposed by a Regulatory Authority, then Lonza shall indemnify and hold Altus harmless from any and all losses resulting from lost sales caused directly by such failure to deliver, but not in an amount exceeding the [***]. Further, if such failure to deliver permits Altus under the terms of this Agreement, under Section 3.10 or any other provision of this Agreement, to engage a Third Party manufacturer to supply the applicable Bulk Product Component due to such failure by Lonza, then Lonza shall also pay to Altus [***] and of [***] for [***] that are not incorporated into Bulk Product Component. Execution Original PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Related to Damages for Regulatory Failures

  • 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.

  • LIABILITY FOR FAILURE TO COMPLETE TRANSACTIONS If We do not

  • 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.

  • Reportable Events Involving the Xxxxx Law Notwithstanding the reporting requirements outlined above, any Reportable Event that involves solely a probable violation of section 1877 of the Social Security Act, 42 U.S.C. §1395nn (the Xxxxx Law) should be submitted by Practitioner to CMS through the self-referral disclosure protocol (SRDP), with a copy to the OIG. If Practitioner identifies a probable violation of the Xxxxx Law and repays the applicable Overpayment directly to the CMS contractor, then Practitioner is not required by this Section III.G to submit the Reportable Event to CMS through the SRDP.

  • Our Liability for Failure to Complete Transactions If we do not properly complete a transaction from your Card on time or in the correct amount according to our Agreement with you, we will be liable for your losses or damages. However, there are some exceptions. We will not be liable, for instance:

  • Liability for Failure to Make Transfers If we do not complete a transfer to or from your account on time or in the correct amount according to our agreement with you, we will be liable for your losses or damages. However, there are some exceptions. We will not be liable, for instance:

  • OUR LIABILITY FOR FAILURE TO STOP PAYMENT If You order Us to place a stop payment on one of Your pre-authorized payments 3 business days or more before the transfer is scheduled, and We do not do so, We will be liable for losses or damages, to the extent provided by law. TRANSACTION SLIPS. Except for mail-in transactions and certain small-value transactions, You can get a receipt at the time You make any transaction to or from Your Account through the use of Your Card. When an electronic fund transfer has been made during any given month, You will receive a monthly statement to reflect all electronic fund transfers to or from Your Account during that statement period. In any case, You will receive a statement at least quarterly. FEES. We may assess reasonable charges against Your Account for transactions performed at electronic terminals. If so, We will specify any charges for these or other types of electronic transactions, including automatic transfers, on an accompanying pricing document. We will explain the charges to You when You open Your Account. You will be provided with a fee schedule, and other specified information after Your Account is established. Additional fee schedules are available at any of Our office locations. When You use an ATM not owned by Us, You may be charged a fee by the ATM operator, or any network used, and You may be charged a fee for a balance inquiry even if You do not complete a fund transfer.

  • Prevention or Delay of Performance by the Company or the Depositary Neither the Depositary nor the Company nor any of their respective directors, employees, agents or affiliates shall incur any liability to any Owner or Holder: (i) if by reason of (A) any provision of any present or future law or regulation or other act of the government of the United States, any State of the United States or any other state or jurisdiction, or of any governmental or regulatory authority or stock exchange; (B) (in the case of the Depositary only) any provision, present or future, of the articles of association or similar document of the Company, or any provision of any securities issued or distributed by the Company, or any offering or distribution thereof; or (C) any event or circumstance, whether natural or caused by a person or persons, that is beyond the ability of the Depositary or the Company, as the case may be, to prevent or counteract by reasonable care or effort (including, but not limited to, earthquakes, floods, severe storms, fires, explosions, war, terrorism, civil unrest, labor disputes, criminal acts or outbreaks of infectious disease; interruptions or malfunctions of utility services, Internet or other communications lines or systems; unauthorized access to or attacks on computer systems or websites; or other failures or malfunctions of computer hardware or software or other systems or equipment), the Depositary or the Company is, directly or indirectly, prevented from, forbidden to or delayed in, or could be subject to any civil or criminal penalty on account of doing or performing and therefore does not do or perform, any act or thing that, by the terms of this Deposit Agreement or the Deposited Securities, it is provided shall be done or performed; (ii) for any exercise of, or failure to exercise, any discretion provided for in this Deposit Agreement (including any determination by the Depositary to take, or not take, any action that this Deposit Agreement provides the Depositary may take); (iii) for the inability of any Owner or Holder to benefit from any distribution, offering, right or other benefit that is made available to holders of Deposited Securities but is not, under the terms of this Deposit Agreement, made available to Owners or Holders; or (iv) for any special, consequential or punitive damages for any breach of the terms of this Deposit Agreement. Where, by the terms of a distribution to which Section 4.1, 4.2 or 4.3 applies, or an offering to which Section 4.4 applies, or for any other reason, that distribution or offering may not be made available to Owners, and the Depositary may not dispose of that distribution or offering on behalf of Owners and make the net proceeds available to Owners, then the Depositary shall not make that distribution or offering available to Owners, and shall allow any rights, if applicable, to lapse.

  • Liability for Failure to Stop Payment of Preauthorized Transfers If you order us to stop payment of a preauthorized transfer three (3) business days or more before the transfer is scheduled and we do not do so, we will be liable for your losses or damages.

  • Standard of Care; Uncontrollable Events; Limitation of Liability SMC shall use reasonable professional diligence to ensure the accuracy of all services performed under this Agreement, but shall not be liable to the Company for any action taken or omitted by SMC in the absence of bad faith, willful misfeasance, negligence or reckless disregard by it of its obligations and duties. The duties of SMC shall be confined to those expressly set forth herein, and no implied duties are assumed by or may be asserted against SMC hereunder. SMC shall maintain adequate and reliable computer and other equipment necessary or appropriate to carry out its obligations under this Agreement. Upon the Company's reasonable request, SMC shall provide supplemental information concerning the aspects of its disaster recovery and business continuity plan that are relevant to the services provided hereunder. Notwithstanding the foregoing or any other provision of this Agreement, SMC assumes no responsibility hereunder, and shall not be liable for, any damage, loss of data, delay or any other loss whatsoever caused by events beyond its reasonable control. Events beyond SMC's reasonable control include, without limitation, force majeure events. Force majeure events include natural disasters, actions or decrees of governmental bodies, and communication lines failures that are not the fault of either party. In the event of force majeure, computer or other equipment failures or other events beyond its reasonable control, SMC shall follow applicable procedures in its disaster recovery and business continuity plan and use all commercially reasonable efforts to minimize any service interruption. SMC shall provide the Company, at such times as the Company may reasonably require, copies of reports rendered by independent public accountants on the internal controls and procedures of SMC relating to the services provided by SMC under this Agreement. Notwithstanding anything in this Agreement to the contrary, in no event shall SMC, its affiliates or any of its or their directors, officers, employees, agents or subcontractors be liable for exemplary, punitive, special, incidental, indirect or consequential damages, or lost profits, each of which is hereby excluded by agreement of the parties regardless of whether such damages were foreseeable or whether either party or any entity has been advised of the possibility of such damages.

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