definiens: means an entity that, together with its Affiliates, has an average annual pharmaceutical and/or biotechnology pre - clinical research expenditure of more than [ $ 15,000,000 per year for the three years prior to the applicable transaction ; provided, however, that upon request by [COMPANY], Memory shall provide reasonable documentation to evidence that, or provide a written certification reasonably satisfactory to [COMPANY] from the Industry Buyer to the effect that, the pre - clinical research expenditure of the Industry Buyer together with its Affiliates is less than or equal to $ 15,000,000 per year for the three years prior to the applicable transaction . ] Notwithstanding the foregoing, a bona fide venture capital or private equity firm that is not owned or controlled by, and does not own or control a significant biotechnology or pharmaceutical company shall not be deemed to be an fudustry Buyer . For the purposes of illustration, the Parties consider the following to not be fudustry Buyers because they are bona fide venture capital or private equity firms that are not owned or controlled by, and do not own or control a significant biotechnology or pharmaceutical company : [ VenRock Associates, Kleiner, Perkins, Caufield & Byers, ARCH Venture Partners, and Oxford Bioscience Partners . For the purposes of illustration, the Parties consider the following to be IndUstry Buyers because they are venture capital or private equity firms owned or controlled by, or own or control a significant biotechnology or pharmaceutical company : S.R. One, Ltd., J&J Development Corp., and [COMPANY] Ventures, LLC . ] 1.25 " Initiation of Phase 2a Clinical Triaf ' means the date that a patient is first dosed by or on behalf of [COMPANY], its Affiliate or sublicensee with a Product in a clinical trial on sufficient numbers of patients that is designed to establish the safety and efficacy of a drug for its intended use, and to defme warnings, precautions and adverse reactions that 6 . CONFIDENTIAL TREATMENT IS REQUESTED FOR INFORMATION IN BOLD AND BRACKETS are associated with the drug in the dosage range to be prescribed and that satisfies the requirements of 21 CFR 312.21 ( b ) ( or its successor regulation ), or its foreign equivalent