CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
1.98 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.99 “Phase I Clinical Study” means, as to a specific Licensed Product, a study of such product in humans designed to satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.
1.100 “Phase II Clinical Study” means, as to a specific Licensed Product, (a) a preliminary efficacy and safety human clinical study in any country conducted to evaluate such product for a particular indication or indications in patients with the disease or condition under study, where at least one of the primary endpoints of such study is an efficacy endpoint, or (b) any human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.
1.101 “Phase III Clinical Study” means, as to a specific Licensed Product, (a) a human clinical study in any country, whether controlled or uncontrolled, that is performed to obtain Regulatory Approval of such Licensed Product after preliminary evidence suggesting its effectiveness under evaluation has been obtained, and intended to confirm with statistical significance the efficacy and safety of such Licensed Product, to evaluate its overall benefit-risk relationship and to provide an adequate basis for physician labeling, or (b) a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.
1.102 “Pivotal Trial” means, as to a specific Licensed Product, the first of either a Phase II Clinical Study or Phase III Clinical Study that is intended to be sufficient for obtaining Regulatory Approval for such Licensed Product in any jurisdiction.
1.103 “Proprietary Software” means the software programs licensed by Broad to Company pursuant to the Software License.
1.104 “Prosecution” or “Prosecute” means the preparation, filing, prosecution, issuance and maintenance of Patent Rights, including continuations, continuations-in-part, divisionals, extensions, reexaminations, inter partes review, reissues, supplemental examinations, appeals, interferences, derivation proceedings, oppositions, all other proceedings before the United States Patent and Trademark Office (including the Patent Trial and Appeal Board) and foreign patent offices, and any judicial or other appeals of the foregoing. Cognates of the word “Prosecution” have their correlative meanings.
1.105 “Record Retention Period” has the meaning set forth in Section 5.3.
1.106 “Regulatory Approval” means those clearances or approvals (including pricing or reimbursement approvals, as applicable) of a Regulatory Authority, with respect to any jurisdiction, that are legally required for the sale of Licensed Products in such jurisdiction.
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