definiens: means all Patent Rights Covering Joint Inventions . [ See License Agreement Section 1.71 ] means the Joint Review Committee established purs uant to Section 2.2.1 of the License Agreement . [ See License Agreement Sections 1.73, 2.2.1 ] means a TAK-385 Licensed Compound . [ See License Agreement Section 1.76 ] means any TAK-385 Licensed Product . [ See License Agreement Section 1.77 ] means any IND filed related to a Licensed Product, whether in existence as of the Effective Date or filed by a Party with a Regulator y Authority during the Term, including any suppleme nts or amendments thereto . The Licensed Product INDs as of the Effective Date are set forth on Schedule 1.78 ( a ) ( TAK-385 Licensed Product INDs ) of the License Agreement . [ See License Agreement Section 1.78 ] means all Information and Inventions Controlled b y Licensee or its Affiliates ( other than the [COMPANY] Know - How and Joint Know - How ) during the term that are necessary to Exploit a Licensed Compo und or Licensed Product . Licensee Know - How excludes any Information contained within or Inventions Covered by a published Licensee Patent Right . [ See License Agreement Section 1.83 ] means all Patent Rights Controlled by Licensee or its Affiliates ( other than the [COMPANY] Patent Rights and Joint Patent Rights ) as of the Ef fective Date or during the Term that Cover a Licens ed Compound or any Licensed Product or are otherwise necessary to Exploit a Licensed Compound or a Licensed Produc t. [ See License Agreement Section 1.85 ] means with respect to the TAK-385 Licensed Compou nd or a TAK-385 Licensed Product, worldwide excluding the [COMPANY] Territory . [ See License Agreement Section 1.90 ] means an application for Regulatory Approval ( but excluding any application for approval of pricing or reimbursement for a Licensed Product by any Governm ental Authority ) filed with the EMA . [ See License Agreement Section 1.92 ] or means all activities by or on behalf of a Party r elated to the manufacturing of a Licensed Compound or a Licensed Product, or an y ingredient thereof, including test method develop ment and stability testing, formulation, manufacturing scale -up, manufacturing for Development or Commercializa tion, labeling, filling, processing, packaging, in - proces s and finished Licensed Product or any ingredient t hereof, quality assurance and quality control activities related to manufacturing and release of a Licensed Compound o r a Licensed Product, ongoing stability tests, and regulatory ac tivities related to any of the foregoing . When used as a noun, or means any and all activities involved in Manufacturing . [ See License Agreement Section 1.94 ] means the treatment, prevention, cure, or control of symptoms associated with prostate cancer . [ See License Agreement Section 1.97 ] means a ( a ) New Drug Application or supplemental New Drug Application as contemplated by Section 505(b ) of the FFDCA, submitted to the FDA pursuant to 21 C.F.R. § 314, including any amendments theret o or ( b ) any comparable applications filed in or for cou ntries or jurisdictions outside of the United State s to obtain Regulatory Approval to Commercialize a Licensed Pro duct in that country or jurisdiction . References to herein will refer to a JNDA or MAA as applicable . [ See License Agreement Section 1.98 ] means a Governmental Authority that administers a nd regulates patents, such as the Japan Patent Office, United States Patent and Trademark Office, or other similar Governmental Authority . [ See License Agreement Section 1.107 ] means all : ( a ) patents, including any utility or design patent ; ( b ) patent applications, including provisionals, non - provisionals, substitutions, divi sionals, continuations, continuations in - part or re newals ; ( c ) patents of addition, restorations, extensions, supp lementary protection certificates, registration or confirmation patents, patents resulting from post - grant proceedi ngs, re - issues, and re - examinations ; ( d ) other pate nts or patent applications claiming priority directly or indirect ly to : ( i ) any such specified patent or patent appl ication specified in ( a ) through ( c ), or ( ii ) any patent or patent ap plication from which a patent application specified in ( a ) through ( c ) claim direct or indirect priority ; ( e ) inventor ’s certificates ; ( f ) other rights issued from a Gov ernmental Authority similar to any of the foregoing specified in ( a ) through ( e ) ; and ( g ) in each of ( a ) through ( f ), whether such patent, patent application or other right aris es in the U.S. or any other jurisdiction in the wor ld . [ See License Agreement Section 1.108 ] means an individual, sole proprietorship, partner ship, limited partnership, limited liability partne rship, corporation, limited liability company, business tr ust, joint stock company, trust, incorporated assoc iation, joint venture or similar entity or organization, includin g a government or political subdivision, department or agency of a government . [ See License Agreement Section 1.111 ] means a pivotal clinical trial of a pharmaceutica l product, with a defined dose or a set of defined doses, which trial is designed to ascert ain efficacy and safety of such product, for the pu rpose of enabling the preparation and submission of an NDA with the a pplicable Regulatory Authority and to provide an ad equate basis for physician labeling, as described in 21 C. F.R. § 312.21(c ), as amended ( or its successor regu lation ), or, with respect to any other country or jurisdiction, the e quivalent of such a clinical trial in such other co untry or jurisdiction . [ See License Agreement Section 1.113 ] means the Japanese Pharmaceuticals and Medical De vices Agency and any successor entity . [ See License Agreement Section 1.114 ] means a Party ’s removal or correction of a Licens ed Product following ( a ) notice or request of any Regulatory Authority or ( b ) the good faith determin ation by such Party that an event, incident, or cir cumstance has occurred that required such a recall of such Licens ed Product . A Recall does not include a market with drawal or a stock recovery . [ See License Agreement Section 1.118 ] means any applicable Governmental Authority invol ved in granting Regulatory Approval or issuing a Recall for a Licensed Product in the Territory, including in the U.S. the FDA, i n the E.U