(d) Neither the Company nor, to the Companys knowledge, any of its officers, employees or agents has made an untrue statement of a material fact or fraudulent statement to the FDA or other governmental entity, failed to disclose a material fact required to be disclosed to the FDA or other governmental entity, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, could reasonably be expected to provide a basis for the FDA to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar state or foreign law or regulation or for which debarment is authorized by 21 U.S.C. § 335a(b) or any similar state or foreign law or regulation.
(a) The clinical, pre-clinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Company were and, if still pending, are being conducted in material compliance with standard medical and scientific research procedures. The Company has operated within, and currently is in material compliance with, all applicable rules, regulations and policies of the FDA for such studies. The Company has not received any notices or other correspondence from the FDA or any other governmental entity requiring the termination, suspension or modification of any clinical, pre-clinical, safety or other studies or tests.
4. Representations and Warranties of the Purchasers. Each Purchaser hereby represents and warrants to the Company, severally and not jointly, that:
4.1. Authorization. The Purchaser has full power and authority to enter into the Transaction Agreements. The Transaction Agreements to which such Purchaser is a party, when executed and delivered by the Purchaser, will constitute valid and legally binding obligations of the Purchaser, enforceable in accordance with their terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, and any other laws of general application affecting enforcement of creditors rights generally, and as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies, or (b) to the extent the indemnification provisions contained in the Investors Rights Agreement may be limited by applicable federal or state securities laws.
4.2. Purchase Entirely for Own Account. This Agreement is made with the Purchaser in reliance upon the Purchasers representation to the Company, which by the Purchasers execution of this Agreement, the Purchaser hereby confirms, that the Shares to be acquired by the Purchaser will be acquired for investment for the Purchasers own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Agreement, the Purchaser further represents that the Purchaser does not presently have any contract, undertaking, agreement or arrangement with any Person to sell, transfer or grant participations to such Person or to any third Person, with respect