$100,000 or in excess of $250,000 in the aggregate, (iii) except as set forth in the Schedule of Exceptions, made any loans or advances to any person, other than ordinary advances for travel expenses, or (iv) sold, exchanged or otherwise disposed of any of its assets or rights, other than the sale of its inventory in the ordinary course of business. For the purposes of subsections (a) and (b) of thisSection 2.8, all indebtedness, liabilities, agreements, understandings, instruments, contracts and proposed transactions involving the same person (including persons Inhibrx has reason to believe are affiliated with each other) shall be aggregated for the purpose of meeting the individual minimum dollar amounts of such subsections.
(c)Except as set forth in the Schedule of Exceptions, Inhibrx is not a guarantor nor indemnitor of any indebtedness of any other person.
2.9.Litigation. There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or, to Inhibrx’s knowledge, currently threatened (i) against Inhibrx or any officer, director or key employee of Inhibrx arising out of their employment or board relationship with Inhibrx; (ii) that questions the validity of this Agreement or the right of Inhibrx to enter into this Agreement, or to consummate the transactions contemplated by this Agreement; or (iii) that could reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect on Inhibrx. Neither Inhibrx nor, to Inhibrx’s knowledge, any of its officers, directors or key employees is a party or is named as subject to the provisions of any order, writ, injunction, judgment or decree of any court or government agency or instrumentality (in the case of officers, directors or key employees, such as would affect Inhibrx). There is no action, suit, proceeding or investigation by Inhibrx pending or which Inhibrx intends to initiate. The foregoing includes, without limitation, actions, suits, proceedings or investigations pending or threatened in writing (or any basis therefor known to Inhibrx) involving the prior employment of any of Inhibrx’s employees, their services provided in connection with Inhibrx’s business, any information or techniques allegedly proprietary to any of their former employers or their obligations under any agreements with prior employers.
2.10.Preclinical Development and Clinical Trials.The studies, tests, preclinical development and clinical trials, if any, conducted by or on behalf of Inhibrx are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by Inhibrx and all applicable laws and regulations, including the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. parts 50, 54, 56, 58, 312, and 812. The descriptions of, protocols for, and data and other results of, the studies, tests, development and trials conducted by or on behalf of Inhibrx related to Inhibrx’s proprietary recombinant version of humanalpha-1 antitrypsin (AAT), currently known asINBRX-101, that have been furnished or made available to Chiesi are accurate and complete. Inhibrx is not aware of any studies, tests, development or trials the results of which reasonably call into question the results of the studies, tests, development and trials conducted by or on behalf of Inhibrx, and Inhibrx has not received any notices or correspondence from the FDA (as defined below) or any other governmental entity or any Institutional Review Board (as defined under FDA regulations) or comparable authority requiring the termination, suspension or material modification of any studies, tests, preclinical development or clinical trials conducted by or on behalf of Inhibrx.
2.11.FDA Approvals. Inhibrx possesses all permits, licenses, registrations, certificates, authorizations, orders and approvals from the appropriate federal, state or foreign regulatory authorities necessary to conduct its business as presently conducted, including all such permits, licenses, registrations, certificates, authorizations, orders and approvals required by the U.S. Food and Drug Administration (“FDA”) or any other federal, state or foreign agencies or bodies engaged in the regulation of drugs, pharmaceuticals, medical devices or biohazardous materials. Inhibrx has not received any notice of proceedings relating to the suspension, modification, revocation or cancellation of any such permit, license, registration, certificate, authorization, order or approval. Neither Inhibrx nor, to Inhibrx’s knowledge, any officer, employee or agent of Inhibrx has been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (A) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other governmental entities, (B) debarment, suspension, or exclusion under any Federal Healthcare Programs or by the General Services Administration, or (C) exclusion under 42 U.S.C.Section 1320a-7 or any similar law, rule or regulation of any governmental entities. Neither Inhibrx nor any of its officers, employees, or to the knowledge of Inhibrx, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Application Integrity Policy”) and any amendments thereto, or
4