DCAA and DCMA Matters Sample Clauses

DCAA and DCMA Matters. (i) For purposes of this Section 2.08(b) only, the following definitions apply:
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Related to DCAA and DCMA Matters

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials. (b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading. (c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded. (d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.

  • Certain Additional Matters (a) Any arbitration award shall be a bare award limited to a holding for or against a party and shall be without findings as to facts, issues or conclusions of law (including with respect to any matters relating to the validity or infringement of patents or patent applications) and shall be without a statement of the reasoning on which the award rests, but must be in adequate form so that a judgment of a court may be entered thereupon. Judgment upon any arbitration award hereunder may be entered in any court having jurisdiction thereof. (b) Prior to the time at which an arbitrator is appointed pursuant to Section 8.4, any party may seek one or more temporary restraining orders in a court of competent jurisdiction if necessary in order to preserve and protect the status quo. Neither the request for, or grant or denial of, any such temporary restraining order shall be deemed a waiver of the obligation to arbitrate as set forth herein and the arbitrator may dissolve, continue or modify any such order. Any such temporary restraining order shall remain in effect until the first to occur of the expiration of the order in accordance with its terms or the dissolution thereof by the arbitrator. (c) Except as required by law, the parties shall hold, and shall cause their respective officers, directors, employees, agents and other representatives to hold, the existence, content and result of mediation or arbitration in confidence in accordance with the provisions of Article VIII and except as may be required in order to enforce any award. Each of the parties shall request that any mediator or arbitrator comply with such confidentiality requirement. (d) If at any time the sole arbitrator shall fail to serve as an arbitrator for any reason, the parties shall select a new arbitrator who shall be disinterested as to the parties and the matter in accordance with the procedures set forth herein for the selection of the initial arbitrator. The extent, if any, to which testimony previously given shall be repeated or as to which the replacement arbitrator elects to rely on the stenographic record (if there is one) of such testimony shall be determined by the replacement arbitrator.

  • Transitional Matters (a) Each of the parties acknowledges and agrees that the transition of the Business from the Selling Companies to Buyer will require that certain transactions and relationships will need to be entered into, restructured and reorganized in connection with the transition of the Business from the Selling Companies to Buyer. The parties agree that prior to the Closing Date, the parties shall cooperate with each other to identify all such transactions and relationships and negotiate in good faith to enter into a mutually acceptable Transitional Agreement effective as of the Closing Date, which agreement shall provide for all such transactions and relationships as are reasonably necessary to provide, (i) for (A) the operation of the Business and use of the Purchased Assets by Buyer, (B) the operation and use of the Excluded Assets by Sellers and the Selling Subsidiaries and (C) the separation of the Business, the Purchased Assets and the Assumed Liabilities from Parent and its Affiliates (including the Selling Companies), in each case during the period commencing on and after the Closing Date and ending no later than the one year anniversary of the Closing Date or such longer period as the parties may agree, including the following: (1) the transitioning of the financial systems, assets and hedging valuation systems, asset management systems, payroll and employee benefits systems and any other applicable business operating systems; (2) the provision of rights of access (provided that access to the ALSS Platform shall be governed and limited by the Intellectual Property Rights Agreement and the Services Agreement) to the Parent and its Affiliates to Intellectual Property currently owned (or licensed) by the Selling Companies (and included in the Purchased Assets) and used by Parent or the Selling Companies in the ordinary course of their business, or required by the Selling Companies for the operation and use of the Excluded Assets or Excluded Liabilities; provided, that access to the ALSS Platform and other Software shall be governed solely by the Intellectual Property Rights Agreement and the Services Agreement and, provided further, anything foregoing to the contrary notwithstanding, Buyer shall not be required to disclose or deliver trade secret or confidential information regarding the ALSS Platform, Software or Acquired Intellectual Property unless required by the Intellectual Property Rights Agreement, the Services Agreement or required by law or legal proceedings and under the type of protective provisions in the Intellectual Property Rights Agreement. (3) the provision of rights of access (to the extent not covered by the Intellectual Property Rights Agreement) to Buyer to Intellectual Property currently owned (or licensed) by Parent (or the Selling Companies) and used by the Selling Companies in connection with the Purchased Assets or Assumed Liabilities; (4) moving corporate records related to the Selling Companies; and (5) the provision of office space, computer equipment and supplies sufficient to enable the Selling Companies to complete any transition services; and (ii) for such services and facilities as Sellers and Selling Subsidiaries may require to monitor compliance with, and implementation of the Subservicing Agreement, during its term, including the provision of office space, computer equipment and supplies sufficient to enable Sellers to monitor compliance with the Retained Portfolio Subservicing Agreement throughout its term. (b) In addition to the matters to be identified pursuant to paragraph (a) of this Section 5.12, the Transition Agreement shall specifically provide for the transactions and matters outlined in Section 5.12 of Sellers' Disclosure Schedule. (c) For the purpose of facilitating the transition of the financial system, on or prior to the 15th day prior to the Closing Date, the Selling Companies shall create on their general ledger, a separate general ledger company ("GL Company"), as well as accounts for such GL Company ("Buyer GL Accounts"), which accounts shall be duplicative of the Selling Companies' own accounts ("Seller GL Accounts") and are intended to be used by the Buyer in the operation of the Business, the Purchased Assets and the Assumed Liabilities from and after the Closing Date. From and after the creation of the Buyer GL Accounts, until Closing, the Selling Companies shall maintain such accounts (as duplicate entries on the books of the Selling Companies in the name of the GL Company). From and after Closing until the completion of the transition of the financial system of the Selling Companies, the Buyer shall operate the Business by recording entries using the Buyer GL Accounts, and shall maintain on behalf of the Selling Companies, the Seller GL Accounts on its general ledger. (d) The party receiving service under the Transitional Agreement shall pay to the party providing service the costs incurred by such providing party. Services provided under the Transitional Agreement shall be performed at the same standard as the providing party performs such service for its own account.

  • Additional Actions and Documents Each of the parties hereto hereby agrees to take or cause to be taken such further actions, to execute, deliver, and file or cause to be executed, delivered and filed such further documents, and will obtain such consents, as may be necessary or as may be reasonably requested in order to fully effectuate the purposes, terms and conditions of this Agreement.

  • Additional Matters (a) Any claim on account of a Liability that does not result from a Third-Party Claim shall be timely asserted by written notice given by the Indemnitee to the related Indemnifying Party. Such Indemnifying Party shall have a period of 30 days after the receipt of such notice within which to respond thereto. If such Indemnifying Party does not respond within such 30-day period, such Indemnifying Party shall be deemed to have refused to accept responsibility to make payment. If such Indemnifying Party does not respond within such 30-day period or rejects such claim in whole or in part, such Indemnitee shall be free to pursue remedies as specified by this Agreement and the Ancillary Agreements. (b) In the event of payment by or on behalf of any Indemnifying Party to any Indemnitee in connection with any Third-Party Claim, such Indemnifying Party shall be subrogated to and shall stand in the place of such Indemnitee as to any events or circumstances in respect of which such Indemnitee may have any right, defense or claim relating to such Third-Party Claim against any claimant or plaintiff asserting such Third-Party Claim or against any other Person. Such Indemnitee shall cooperate with such Indemnifying Party in a reasonable manner, and at the cost and expense of such Indemnifying Party, in prosecuting any subrogated right, defense or claim. (c) In the event of an Action in which the Indemnifying Party is not a named defendant, if either the Indemnitee or the Indemnifying Party shall so request, the parties shall endeavor to substitute the Indemnifying Party for the named defendant, if reasonably practicable. If such substitution or addition cannot be achieved or is not requested, the named defendant shall allow the Indemnifying Party to manage the Action as set forth in this Agreement and the Indemnifying Party shall fully indemnify the named defendant against all costs of defending the Action (including court costs, sanctions imposed by a court, attorneys’ fees, experts’ fees and all other external expenses, and the allocated costs of in-house counsel and other personnel), the costs of any judgment or settlement, and the cost of any interest or penalties relating to any judgment or settlement.

  • Compliance with Federal Law, Regulations, and Executive Orders This is an acknowledgement that FEMA financial assistance will be used to fund all or a portion of the contract. The contractor will comply with all applicable Federal law, regulations, executive orders, FEMA policies, procedures, and directives.

  • LAW AND DISPUTES This agreement is governed by Federal law. (i) Any language purporting to subject the U.S. Government to the laws of a U.S. state, U.S. territory, district, or municipality, or foreign nation, except where Federal law expressly provides for the application of such laws, is hereby deleted. (ii) Any language requiring dispute resolution in a specific forum or venue that is different from that prescribed by applicable Federal law is hereby deleted. (iii) Any language prescribing a different time period for bringing an action than that prescribed by applicable Federal law in relation to a dispute is hereby deleted.

  • Compliance with Federal and State Work Authorization and Immigration Laws The Contractor and all subcontractors, suppliers and consultants must comply with all federal and state work authorization and immigration laws, and must certify compliance using the form set forth in Section 7 (“Georgia Security and Immigration Compliance Act Affidavits”). The required certificates must be filed with the Owner and copied maintained by the Contractor as of the beginning date of this contract and each subcontract, supplier contract, or consultant contract, and upon final payment to the subcontractor or consultant. State officials, including officials of the Georgia Department of Audits and Accounts, officials of the Owner, retain the right to inspect and audit the Project Site and employment records of the Contractor, subcontractors and consultants without notice during normal working hours until Final Completion, and as otherwise specified by law and by Rules and Regulations of the Georgia Department of Audits and Accounts.

  • Legal Matters In the opinion of Xxxx Xxxxxx, Authorized Signatory of Prospect Administration, administrator for Prospect Capital Corporation, a Maryland corporation (the “Company”), the certificates evidencing the Notes (the “Note Certificates”) constitute the valid and binding obligations of the Company, entitled to the benefits of the Indenture and enforceable against the Company in accordance with their terms under the laws of the State of New York subject to applicable bankruptcy, insolvency and similar laws affecting creditors’ rights generally, concepts of reasonableness and equitable principles of general applicability (including, without limitation, concepts of good faith, fair dealing and the lack of bad faith), provided that such counsel expresses no opinion as to the effect of fraudulent conveyance, fraudulent transfer or similar provision of applicable law on the conclusions expressed above. This opinion is given as of the date hereof and is limited to the law of the State of New York as in effect on the date hereof. In addition, this opinion is subject to the same assumptions and qualifications stated in the letter of Skadden, Arps, Slate, Xxxxxxx & Xxxx, LLP dated March 8, 2012, filed as Exhibit (l)(5) to the Company’s registration statement on Form N-2 (File No. 333-176637) and to the further assumptions that (i) the Note Certificates have been duly authorized by all requisite corporate action on the part of the Company and duly executed by the Company under Maryland law, and (ii) they were duly authenticated by the Trustee and issued and delivered by the Company against payment therefor in accordance with the terms of the Fifth Amended and Restated Selling Agent Agreement and the Indenture. Capitalized terms used in this paragraph without definition have the meanings ascribed to them in the accompanying prospectus supplement.

  • Compliance with Laws and Documents Borrower will, and will cause each other Credit Party to, comply with all Laws, their respective certificates (or articles) of incorporation, bylaws, regulations and similar organizational documents and all Material Agreements to which any Credit Party is a party, if a violation, alone or when combined with all other such violations, could reasonably be expected to have a Material Adverse Effect.

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