1.100 “Prosecute and Maintain” or“Prosecution and Maintenance”with respect to a particular Patent, means all activities associated with the preparation, filing, prosecution and maintenance of such Patent, together with the conduct of interferences, derivation proceedings,interpartes review and post-grant review, the defense of oppositions and other similar proceedings with respect to that Patent, including any activities associated with claims, including as a counterclaim or declaratory judgment action, of unpatentability, invalidity or unenforceability of such Patent that are brought by a Third Party in connection with an Infringement under Section 8.3.
1.101 “Prosecuting Party” has the meaning set forth in Section 8.2.2.
1.102 “Receiving Party” has the meaning set forth in Section 11.1.1.
1.103 “Regulatory Approval” means, collectively, any and all approvals (including supplements, amendments,pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations, permits, notifications, and authorizations (including marketing and labeling authorizations) or waivers of any Regulatory Authority that are necessary for the testing, Research, development, registration, manufacture (including formulation), use, storage, import, export, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a pharmaceutical product (including any Compound or Product) in any country or jurisdiction, including Pricing and Reimbursement Approval, as applicable.
1.104 “Regulatory Authority” means any Governmental Authority that has responsibility in its applicable jurisdiction over the testing, Research, development, registration, manufacture (including formulation), use, storage, import, export, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of pharmaceutical products (including any Compound or Product) in a given jurisdiction. For countries where governmental approval is required for pricing or reimbursement for a pharmaceutical product (including any Compound or Product) to be reimbursed by national health insurance (or its local equivalent), Regulatory Authority includes any Governmental Authority whose review or approval of pricing or reimbursement of such product is required.
1.105 “Regulatory Filing” means, collectively, any and all applications, filings, submissions, approvals (including supplements, amendments,pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations, permits, notifications, and authorizations (including marketing and labeling authorizations) or waivers with respect to the testing, Research, development, registration, manufacture (including formulation), use, storage, import, export, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product made to or received from any Regulatory Authority in a given country, including INDs.
1.106 “Replacement Target” has the meaning set forth in Section 4.2.2.
1.107 “Research” means, with respect to a Collaboration Target and a Compound, any research andpre-clinical activities through delivery of a Data Package for such Collaboration Target, as set forth in the applicable Research Plan for such Collaboration Target.
1.108 “Research Budget” has the meaning set forth in Section 4.3.
1.109 “Research Plan” has the meaning set forth in Section 4.3.
1.110 “Research Term” means the period of [* * *] from the Effective Date, as may be extended by Lilly pursuant to Section 4.6.
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