definiens: means a Biologics License Application and amendments ther eto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq ., for FDA approval of a Therapy and m eans a supplemental BLA ; and means a New Drug Applic ation and amendments thereto filed pursuant to the requiremen ts of the FDA, as defined in 21 C.F.R. § 314 et seq ., for FDA approva l of a Therapy and means a supplemental NDA ; Non - Publishing Party is defined in Clause 14.4.1 ; Opt - Out Candidate/ Therapy Is defined in Clause 17.2.1 ; Party or Parties is defined in the Preamble ; Patent(s ) means any and all patents and patent applications a nd any patents issuing therefrom or claiming priority therefrom, w orldwide, together with any extensions ( including patent term extensio ns and supplementary protection certificates ) and renewals thereof, reissues, reexaminations, substitutions, confirmation patents, registration patents, invention certificates, patents of additio n, renewals, divisionals, continuations, and continuations - in - pa rt of any of the foregoing ; Person means an individual, sole proprietorship, partnersh ip, limited partnership, limited liability partnership, corpora tion, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization ; Phase I Clinical Trial means a human clinical trial, the principal purpose of which is preliminary determination of safety of a Therapy in healthy individuals or patients as described in 21 C.F.R. § 312.21(a ), o r similar clinical study in a country other than the US ; 132265684 v23 Page 10 Execution Copy Phase II Clinical Trial means a human clinical trial, the principal purpose of which is a preliminary determination of efficacy of a Therapy in patients being studied as described in 21 C.F.R. § 312.21(b ), or si milar clinical study in a country other than the US ; provided, that, to the extent there is any ambiguity as to whether a given human clinical tria l constitutes a Phase II Clinical Trial or a clinical trial, such trial shall be a Phase II Clinical Trial for the purposes of this Agreement ; Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the effica cy and safety of a Therapy for one or more indications in order to obt ain Marketing Approval of such Therapy for such indication(s ), as further defined in 21 C.F.R. § 312.21(c ) or a similar clinical study in a country other than the US ; provided, that, to the extent there is any ambiguity as to whether a given human clinical trial constitutes a Phase III Clinical Trial or a clinical trial, such trial shall be a Phase III Clinical Trial for the purposes of this Agreement ; Phase IV Clinical Trial means a human clinical trial, or other test or stud y, of a Therapy that is ( a ) commenced after receipt of the initial Regul atory Approval for such Therapy in the country for which such clinical trial is being conducted, and that is conducted within the paramet ers of the Regulatory Approval for such Therapy ( and which may include investigator sponsored clinical trials ), including a clinical trial conducted due to the request or requirement of a Re gulatory Authority or as a condition of a previously granted Regulator y Approval, but shall not include any Phase III Clinical Trial ( inc luding any trial ), ( b ) an investigator sponsored clini cal trial approved by the JCC that does not fall within the parameters of a Therapy ’s Regulatory Approval, or ( c ) any REMS ( Risk Evaluati on and Mitigation Strategy)/RMP ( Risk Management Plan ) rel ated study of a Therapy in a country in the Territory after Regulat ory Approval of such Therapy has been obtained from an appropriate Regulatory Authority in such country . Phase IV Clinical Trials may include trials or studies conducted in support of post - Regulatory Approval exploitation of such Therapy ( for example only, pricing / reimbursement, epidemiological studies, mod eling and pharmacoeconomic studies, post - marketing surveillan ce studies and health economics studies ) ; POC Criteria means the criteria mutually agreed between the Part ies in writing the fulfillment of which will constitute successful Com pletion of the POC Phase ; POC Phase means the initial proof of concept phase performed in accordance with the POC Plan ; POC Plan means the plan for the POC Phase as set out in Exhi bit 1 as amended from time to time in accordance with this Agreement ; POC Target means the Target that is the subject of the POC Pla n ; 132265684 v23 Page 11 Execution Copy Prosecute or Prosecute and Maintain or Prosecution and Maintenance means, with respect to a Patent, all activities ass ociated with the preparation, filing, prosecution and maintenance of such Patent, as well as activities associated with re - examinations, reissues, applications for patent term adjustments and extens ions, supplementary protection certificates and the like with respect to that Patent, together with the conduct of interferences, derivation proceedings, pre- and post - grant proceedings, the d efense of opp ositions and other similar proceedings with respect to that Patent ; Prosecuting Party means the Party responsible for Prosecution under C lauses 12.2 and 12.3 of this Agreement ; Publishing Party is defined in Clause 14.4.1 ; Quality Agreement means, as relevant in the context of this Agreement, a written agreement that documents the responsibilities and q uality expectations between ( a ) Bellicum and any internal or external s upplier, contract manufacturer or service provider ( including, to the extent applicable, [COMPANY] ) or ( b ) [COMPANY] and any internal or external supplier, contract manufacturer or service provider ( including, to the extent applicable, Bellicum ) ; Regulatory Approval means the technical, medical and scientific license s, registrations, authorizations and approvals required for marketing or use of a Therapy ( including approvals of, BLAs, IND applicat ions, pre- and post- approvals, and labeling approvals and any sup plements and amendments to any of such approvals ) of any nationa l, supra - national, regional, state or local regulatory agency, departm ent, bureau, commission, council or other governmental entity, n ecessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of a Therapy in a regulatory jurisdiction . In the US, Regulatory Approval means approval of any Marketing Approval Application or equivalent by the FDA