We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

ANDA Para IV Sample Clauses

ANDA Para IVIn case of an ANDA Challenge (under the Drug Price Competition and Patent Term Restoration Act of 1984 and under Section 505(j) of the Federal Food, Drug, and Cosmetic Act of 1938), it shall be [****] responsibility and obligation to initiate the lawsuit within [****] ([****]) days following the ANDA Challenge notification date, if any Licensed Patent or Joint Product IP listed in the Orange Book would be infringed or suspected to be infringed by an ANDA Challenge filer. [****] and [****] shall immediately consult and cooperate fully to determine a course of action, including but not limited to, the commencement of legal action by [****] or both of [****] and [****] to terminate any Infringement of a Licensed Patent or Patent within the Joint Product IP or LICENSEE Product Technology Patent. [****] shall actively be involved and cooperate in the prosecution of any such suit, including settlement discussions. Subject to the immediately following, [****] shall bear all the pre-suit [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED legal costs (dispute preparation) and the suit legal costs (costs associated with the litigation law firm, appointed experts, experts’ reports, or analytical tests) and its full own fact discovery costs. [****] will reimburse [****] for a reasonable portion of the pre-suit and suit legal costs, [****]. Such reimbursement shall amount to [****] of the pre-suit and suit legal costs in maximum. In order to be prepared to defend against ANDA Challenges at any time, the Joint IP Committee will determine a common patent litigation firm (litigation counsel) and coordinate the defence strategy with the appointed patent litigation firm including patent settlement negotiations. LICENSOR and LICENSEE shall bear their own internal and out-of-pocket costs incurred by their activities and support provided in or for the joint defence team. The joint defence team shall be operational at the latest [****] months after the first FDA marketing approval (i.e. [****] months prior to the first possible ANDA Challenge filing).

Related to ANDA Para IV

  • PayPal’s Buyer Protection Program When you buy something from a seller who accepts PayPal, you may be eligible for a refund under PayPal’s Buyer Protection program. When applicable, PayPal’s Buyer Protection program entitles you to reimbursement for the full purchase price of the item plus the original shipping costs you paid, if any. PayPal determines, in its sole discretion, whether your claim is eligible for PayPal’s Buyer Protection program. PayPal’s original determination is considered final, but you may be able to file an appeal of the decision with PayPal if you have new or compelling information not available at the time of the original determination or you believe there was an error in the decision-making process. The program terms and conditions are set out in PayPal’s Buyer Protection program page and form part of this user agreement.

  • COOPERATIVE PURCHASING PROGRAM PARTICIPATION Arkansas' Purchasing Law provides that local public procurement units (counties, municipalities, school districts, certain nonprofit corporations, etc.) may participate in state purchasing contracts. The contractor therefore agrees to sell to Cooperative Purchasing Program participants at the option of the program participants. Unless otherwise stated, all standard and special terms and conditions listed within the contract must be equally applied to such participants.

  • Cloud Computing State Risk and Authorization Management Program In accordance with Senate Bill 475, Acts 2021, 87th Leg., R.S., pursuant to Texas Government Code, Section 2054.0593, Contractor acknowledges and agrees that, if providing cloud computing services for System Agency, Contractor must comply with the requirements of the state risk and authorization management program and that System Agency may not enter or renew a contract with Contractor to purchase cloud computing services for the agency that are subject to the state risk and authorization management program unless Contractor demonstrates compliance with program requirements. If providing cloud computing services for System Agency that are subject to the state risk and authorization management program, Contractor certifies it will maintain program compliance and certification throughout the term of the Contract.

  • 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.

  • MERCURY ADDED CONSUMER PRODUCTS Contractor agrees that it will not sell or distribute fever thermometers containing mercury or any products containing elemental mercury for any purpose under this Contract.

  • SMALL BUSINESS PARTICIPATION AND DVBE PARTICIPATION REPORTING REQUIREMENTS a. If for this Contract Contractor made a commitment to achieve small business participation, then Contractor must within 60 days of receiving final payment under this Contract (or within such other time period as may be specified elsewhere in this Contract) report to the awarding department the actual percentage of small business participation that was achieved. (Govt. Code § 14841.) b. If for this Contract Contractor made a commitment to achieve disabled veteran business enterprise (DVBE) participation, then Contractor must within 60 days of receiving final payment under this Contract (or within such other time period as may be specified elsewhere in this Contract) certify in a report to the awarding department: (1) the total amount the prime Contractor received under the Contract; (2) the name and address of the DVBE(s) that participated in the performance of the Contract; (3) the amount each DVBE received from the prime Contractor; (4) that all payments under the Contract have been made to the DVBE; and (5) the actual percentage of DVBE participation that was achieved. A person or entity that knowingly provides false information shall be subject to a civil penalty for each violation. (Mil. & Vets. Code § 999.5(d); Govt. Code § 14841.)

  • Please see the current Washtenaw Community College catalog for up-to-date program requirements Conditions & Requirements

  • State Approval of Replacement Personnel The Engineer may not replace the project manager or key personnel without prior consent of the State. The State must be satisfied that the new project manager or other key personnel is qualified to provide the authorized services. If the State determines that the new project manager or key personnel is not acceptable, the Engineer may not use that person in that capacity and shall replace him or her with one satisfactory to the State within forty-five (45) days.

  • Acknowledgement and Consent to Bail-In of EEAAffected Financial Institutions Notwithstanding anything to the contrary in any Loan Document or in any other agreement, arrangement or understanding among any such parties, each party hereto acknowledges that any liability of any EEAAffected Financial Institution arising under any Loan Document, to the extent such liability is unsecured, may be subject to the write-down and conversion powers of an EEAthe applicable Resolution Authority and agrees and consents to, and acknowledges and agrees to be bound by: (a) the application of any Write-Down and Conversion Powers by an EEAthe applicable Resolution Authority to any such liabilities arising hereunder which may be payable to it by any party hereto that is an EEAAffected Financial Institution; and (b) the effects of any Bail-in Action on any such liability, including, if applicable: (i) a reduction in full or in part or cancellation of any such liability; (ii) a conversion of all, or a portion of, such liability into shares or other instruments of ownership in such EEAAffected Financial Institution, its parent undertaking, or a bridge institution that may be issued to it or otherwise conferred on it, and that such shares or other instruments of ownership will be accepted by it in lieu of any rights with respect to any such liability under this Agreement or any other Loan Document; or (iii) the variation of the terms of such liability in connection with the exercise of the write-down and conversion powers of any EEAthe applicable Resolution Authority.

  • Regulatory Good Standing Certification - Explanation - Continued If Vendor responded to the prior attribute that "No", Vendor is not in good standing, Vendor must provide an explanation of that lack of good standing here for TIPS consideration.