2. Publications by company and university scientists describing results that depend on single materials justify an obligation or, at the very least, an expectation or desire on the part of the authors to make such materials available to other researchers. This preserves the integrity of the published research by allowing other scientists to replicate the reported results. In some cases, materials may be limited in supply or consumed in research, so it is not possible to additionally supply other scientists. In a fixed amount lower than the price, the total value of the premium is negotiated in advance. This requires the pass-through entity to know both the unit price and the total number of units supplied. In an agreement on fixed prices, there are certainly negotiated costs per unit, for example.B. Per patient in a clinical study (or participant in a non-clinical human trial), however, the total amount of the price may be unknown at the time of the conclusion of the agreement. Since this type of agreement is based on a “fixed rate” as opposed to a “fixed amount” as defined in 45 CFR 75.201, entering into this type of agreement does not require prior authorization, unless there are other factors that would require prior authorization from the NIH, in accordance with the NIHGPS. B. Who owns what? Data from a clinical study is collected on the site by the PI on sponsor-approved case report forms (“FIUs”). In general, the sponsor owns the completed FIUs and all the study data (which can have real value).
The hospital owns the medical records, IP research notes and corresponding documentation, as well as all intellectual property resulting from the study, usually subject to an option by the sponsor to obtain an intellectual property license. See section 2.1 of the CTA example. 17 Steve L. Bertha, Intellectual Property Activities in U.S. Research Universities, 36 IDEA 513, 520 (1996); See Floyd Bloom, M.D., Science and Technology Policy: A Scientist`s View, 33 Cal. W. L. Rev. 63, 65-66 (1996) (provided that just over 10% of the funds spent by health-related industries (about $700 billion) are spent on funding private universities or research institutes); Kuhlman, above Note 2 to 326. Often, an MTA is obtained when a university researcher wishes to acquire private equipment. The researcher must forward the agreement to OSP or TVC for verification and signature. The OSP and tvC cooperate to verify, modify and accept external ASAs.
23 Cf. Chew, footnotes 6 to 272 (recalling that universities see companies as new sources of research funding, as public funding for academic research continues to decline); see also Korn, a.a.O. Notes 2-200 (arguing that the main scientific incentives for joint ventures with industry are to secure a new source of research funding, improve the quality of science and improve the technology that will be made public); see id. 199 (arguing that, although industry`s motivation for joint research with universities may be based on a number of factors, including financial reward, access to new technologies and the promotion of basic research per se, the primary motivation for any company decision is based on the profit margin). . . .