forth in CFR Title 21, ICH GMP Guidelines Q7, current step 5 version, dated 10 November 2000, as amended from time to time, national legislation implementing European Community Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use as amended by European Community Directives 2003/94/EC, the Rules Governing Medicinal Products in the European Community, Volume 4, including annexes.
GxP means GCP, GLP or GMP or any combination thereof, as applicable.
IND means an Investigational New Drug application filed with the FDA, a Clinical Trial Application filed with the EMA or any equivalent in any country where a regulatory filing is required or obtained for commencement of human clinical trials of a pharmaceutical product.
Infringement Proceeding has the meaning set forth in Section 5.7.4.
Innate Cell Engager means an engineered protein with a non-natural immunoglobulin (e.g. IgA, D, E, G or M) structure designed to engage with a target on the surface of an immune effector cell (e.g. NK cell or macrophage) and a specific target on a tumor cell.
Intellectual Property Rights or IP means, with respect to any technology, all existing and future intellectual property rights (but excluding any Know-How) relating to such technology, including all Patent Rights as well as legally protected trade secrets, copyrights and other intellectual property rights of any kind.
Joint IP has the meaning set forth in Section 5.2.
Joint Patent Rights has the meaning set forth in Section 5.5.
Know-How means any data, results, information, know-how, trade secrets, techniques, methods, processes, protocols, inventions, modifications, designs or materials of any type or kind, patentable or otherwise, but excluding any of the foregoing to the extent claimed by any issued Patent Right.
Lead IP Party has the meaning set forth in Section 5.5.
Losses has the meaning set forth in Section 9.2.1.
Negotiation Period means a [***] following the Option Period.
Option Period means a [***] following the Assessment Period.
Patent Right means (a) all patent applications filed or having legal force in any country or jurisdiction, including all provisional patent applications; (b) all patents that have issued or in the future will be issued from such applications, including method, process, utility, model and design patents and certificates of invention; and (c) all divisionals, continuations, continuations in part, supplement protection certificates, reissues, re-examinations, renewals, extensions or additions to any such patent application and patents.
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