definiens: means the person ( in accord a nce with Article 48 of Directive 2001/83 / EC and wit h Article 13(2 ) of Directive 2001/20 / EC ), qualified t o perform batch release of Product from the Facilit y ; 1.31 means materials, components and dev ices received by [COMPANY] from ImmunoCellular ( including ImmunoCellular Materials ) or ImmunoCellular ’s suppliers, or purchased directly by [COMPANY] from its own qualified suppl iers, in each case accompanied by a certificate of analysis, for the purpose of Processing such materi al into Product . Applicable donor material will be obtained by ImmunoCellular in compliance with EU Co mmission Directive 2004/23 / EC ( Quality and safety of human tissue and cells ) ; 1.32 means any and all permit s, approvals, licenses, regis trations, or authorizations of any Government Competent Authority necessary for [COMPANY] to provide the Services ; 1.33 means when a Qualified Person has complet ed the review of all necessary testing results and certified that the Batch of Pr oduct has been manufactured in accordance with the relevant Specification, cGMP and all other Applicable Law . The Qualified Pe rson shall Release the batch of Product to ImmunoCellular or it designees before or as soon as possible after delivery of the Prod uct to ImmunoCellular or its designees and shal l be construed accordingly ; 1.34 means all Intellectual Property Rights owned or Controlled by ImmunoCellular that are necessary for the performance of the Services in accordance with this Agreement . with respect to a n Intellectual Property Right matter, shall mean th e legal authority or right of a Party or its Affiliat e to grant a license or sublicense of Intellectual Property Rights to t he other Party hereto, or to otherwise disclose pro prietary or trade secrets information to the other Party, without breaching the terms of any agr eement with a Third Party, or infringing upon the Intellectual Property Rights of a Third Party, or m isapprop riating the proprietary or trade secret information of a Third Party ; 1.35 has the meaning set out in Section 9.6 ; 1.36 means all technical and non- technical information provided by or on behalf of ImmunoCellular to [COMPANY] that at the time of first disclosure by or on behalf of ImmunoCellular to [COMPANY] was neither ( i ) known to [COMPANY] as demonstrated by written records existing at the time of such disclosure nor ( ii ) freely available in the public domain ; 1.37 means Raw Materials and all materials and equipment provided by ImmunoCellular, its Affiliates, contractors ( includ ing vendors and suppliers ) or agents to [COMPANY] as described in Schedule 3 . With re spect to biological materials, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS D OCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24 B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED