use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product; and (ii) such trial is a registrational trial that, if successful, would be sufficient to support the filing of an application for Regulatory Approval for such product in the United States or the EU, as evidenced by (A) an agreement with or statement from the FDA or the EMA on a ‘Special Protocol Assessment’ or equivalent, or (B) other guidance or minutes issued by the FDA or EMA, for such registrational trial, in each case (of (a) and (b)), regardless of whether the sponsor of such trial identifies, characterizes or refers to such trial as a “Phase 3,” “Phase 2b” or “Phase 2b/3” trial (or otherwise) in the applicable protocol, on clinicaltrials.gov, or in any other context.
1.121 “Prior Collaboration Agreement” has the meaning set forth in the recitals.
1.122 “Products” means, collectively, the Artiva Product and the Affimed Product. A “Product” means either the Artiva Product or the Affimed Product, as applicable.
1.123 “Promote” or “Promotion” means, with respect to the Combination Therapy, activities directed to the marketing, promoting or detailing such Combination Therapy in any Indication in the Field in the Territory following Regulatory Approval for the Combination Therapy in such Indication.
1.124 “Promotional Materials” means all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, leave items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, and broadcast advertisements, in each case, created by a Party or on its behalf and used or intended for use by or on behalf of such Party in connection with Commercialization of its Product or the Promotion of the Combination Therapy in the Field in the Territory.
1.125 “Prosecution and Maintenance” means, with regard to a given Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as any ex parte and inter partes proceedings, including reexaminations, reissues, applications for patent term extensions, interferences, derivation proceedings, post grant review proceedings, oppositions, litigations, arbitrations and other similar proceedings with respect to such Patent.
1.126 “Protocol” has the meaning set forth in Section 5.5.
1.127 “Publication” has the meaning set forth in Section 12.2(b).
1.128 “Quality Agreement” has the meaning set forth in Section 5.13.
1.129 [***].
1.130 “Receiving Party” has the meaning set forth in Section 11.2(a).
1.131 “Recipient Party” has the meaning set forth in Section 9.4(b)(i).
1.132 “Regulatory Approvals” means any and all permissions (other than the Manufacturing, pricing and reimbursement approvals) required to be obtained from the relevant Regulatory Authorities and any other competent governmental authority for the Commercialization of any Product or the Promotion of the Combination Therapy in a given country or regulatory jurisdiction in the Territory.
1.133 “Regulatory Authority” means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in any country or territory of the world with jurisdiction over the Development, Manufacture or Commercialization of a Product or Development or Promotion of the Combination Therapy, including the FDA and the EMA.
1.134 “Regulatory Materials” means regulatory applications, submissions, notifications, correspondences, registrations, INDs, Regulatory Approvals or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize a Product or Develop or Promote the Combination Therapy in a particular country or regulatory jurisdiction in the Territory.