definiens: meansa Biologics License Application and amendments thereto filedpursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq ., for FDA approval of a Therapy and means asupplemental BLA ; and means a New Drug Application andamendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq ., for FDA approval of a Therapyand 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 and any patentsissuing therefrom or claiming priority therefrom, worldwide, togetherwith any extensions ( including patent term extensions andsupplementary protection certificates ) and renewals thereof, reissues, reexaminations, substitutions, confirmation patents, registration patents, invention certificates, patents of addition, renewals, divisionals, continuations, and continuations - in - part of anyof the foregoing;Person means an individual, sole proprietorship, partnership, limitedpartnership, limited liability partnership, corporation, limited liabilitycompany, business trust, joint stock company, trust, unincorporatedassociation, joint venture or other similar entity or organization;Phase I Clinical Trial means a human clinical trial, the principal purpose of which ispreliminary determination of safety of a Therapy in healthyindividuals or patients as described in 21 C.F.R. § 312.21(a ), orsimilar clinical study in a country other than the US;132265684 v23 Page 10Execution CopyPhase II Clinical Trial means a human clinical trial, the principal purpose of which is apreliminary determination of efficacy of a Therapy in patients beingstudied as described in 21 C.F.R. § 312.21(b ), or similar clinicalstudy in a country other than the US ; provided, that, to the extentthere is any ambiguity as to whether a given human clinical trialconstitutes a Phase II Clinical Trial or a clinical trial, such trial shall be a Phase II Clinical Trial for the purposes of thisAgreement;Phase III Clinical Trial means a human clinical trial, the principal purpose of which is todemonstrate clinically and statistically the efficacy and safety of aTherapy for one or more indications in order to obtain MarketingApproval of such Therapy for such indication(s ), as further defined in21 C.F.R. § 312.21(c ) or a similar clinical study in a country otherthan the US ; provided, that, to the extent there is any ambiguity asto whether a given human clinical trial constitutes a Phase IIIClinical Trial or a clinical trial, such trial shall be aPhase III Clinical Trial for the purposes of this Agreement;Phase IV Clinical Trial means a human clinical trial, or other test or study, of a Therapy thatis ( a ) commenced after receipt of the initial Regulatory Approval forsuch Therapy in the country for which such clinical trial is beingconducted, and that is conducted within the parameters of theRegulatory Approval for such Therapy ( and which may includeinvestigator sponsored clinical trials ), including a clinical trialconducted due to the request or requirement of a RegulatoryAuthority or as a condition of a previously granted RegulatoryApproval, but shall not include any Phase III Clinical Trial ( includingany trial ), ( b ) an investigator sponsored clinical trialapproved by the JCC that does not fall within the parameters of aTherapy ’s Regulatory Approval, or ( c ) any REMS ( Risk Evaluationand Mitigation Strategy)/RMP ( Risk Management Plan ) related studyof a Therapy in a country in the Territory after Regulatory Approvalof such Therapy has been obtained from an appropriate RegulatoryAuthority in such country