FDA Issues Clause Samples

FDA Issues. Immediately upon receipt, but in no event later than one business day after receipt thereof, PPD shall provide CLIENT with a copy of any correspondence or notice it receives from the FDA relating to products or services covered by this Agreement. Further, PPD agrees to cooperate with CLIENT, if requested, in corresponding with the FDA or in filing any documents with respect to the products covered by this Agreement, as CLIENT deems necessary or desirable. Such services will be charged as stated on Attachment A.
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FDA Issues. No Loan Party has received any instruction, letter or other communication (whether written or oral) from the FDA that could reasonably be expected to impact negatively, or restrict, any Loan Party’s ability to hold any Inventory or other assets for sale in the ordinary course of business. No Loan Party is aware of any litigation, suit, or administrative proceeding, or any threat in writing with respect thereto, by the FDA affecting any Loan Party or the Collateral.
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Related to FDA Issues

  • Open Issues (a) Notwithstanding any provision of the Registry Agreement to the contrary (including Sections 7.6 and 7.7 thereof), Registry Operator agrees that the following requirements, procedures and provisions of the Registry Agreement (including the documents incorporated by reference therein) may be modified and amended by ICANN after the date hereof, without the consent of Registry Operator: i. Specification 6 – Registry Interoperability and Continuity Specifications; ii. Trademark Clearinghouse Requirements (§ 1 of Specification 7 of the Registry Agreement); iii. Trademark Post-­‐Delegation Dispute Resolution Procedure (§ 2.a of Specification 7 of the Registry Agreement);

  • Regulatory Issues 3.3.1 The Licensee shall be solely responsible for determining which jurisdictions they choose to market to and receive ▇▇▇▇▇▇ from. 3.3.2 The Licensee shall be responsible for determining the legality of accepting ▇▇▇▇▇▇ in whichever jurisdictions they choose to market to and receive ▇▇▇▇▇▇ from. 3.3.3 The Licensee shall indemnify UNITED for any reasonable legal costs, and fines that arise as a result of the Licensee choosing to accept ▇▇▇▇▇▇ from any jurisdiction that determines or has determined that Internet wagering is illegal.

  • Preference Issues If any Senior Secured Party is required in any Insolvency or Liquidation Proceeding or otherwise to disgorge, turn over or otherwise pay any amount to the estate of the Company or any other Grantor (or any trustee, receiver or similar Person therefor), because the payment of such amount was declared to be fraudulent or preferential in any respect or for any other reason, any amount (a “Recovery”), whether received as proceeds of security, enforcement of any right of setoff or otherwise, then the Senior Obligations shall be reinstated to the extent of such Recovery and deemed to be outstanding as if such payment had not occurred and the Senior Secured Parties shall be entitled to the benefits of this Agreement until a Discharge of Senior Obligations with respect to all such recovered amounts. If this Agreement shall have been terminated prior to such Recovery, this Agreement shall be reinstated in full force and effect, and such prior termination shall not diminish, release, discharge, impair or otherwise affect the obligations of the parties hereto. Each Second Priority Representative, for itself and on behalf of each Second Priority Debt Party under its Second Priority Debt Facility, hereby agrees that none of them shall be entitled to benefit from any avoidance action affecting or otherwise relating to any distribution or allocation made in accordance with this Agreement, whether by preference or otherwise, it being understood and agreed that the benefit of such avoidance action otherwise allocable to them shall instead be allocated and turned over for application in accordance with the priorities set forth in this Agreement.

  • Year 2000 Issues Each of the Borrower and its Subsidiaries has made a full and complete assessment of the Year 2000 Issues and has a realistic and achievable program for remediating the Year 2000 Issues on a timely basis. Based on this assessment and program, the Borrower does not reasonably anticipate any Material Adverse Effect as a result of Year 2000 Issues.

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).