1.43 Patents means (a) pending patent applications, issued patents, utility models and designs; (b) reissues, substitutions, registrations, validations, re-examinations, continuations, continued prosecution applications, continuations-in-part or divisions of or to any of the foregoing; and (c) extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificates or the equivalent thereof.
1.44 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.
1.45 Phase 2 Clinical Trial means a study in humans of the safety, dose range and efficacy of a Licensed Cell Product that is designed to generate sufficient data to commence a Phase 3 Clinical Trial pursuant to 21 C.F.R. 312.21 or corresponding provision outside the United States.
1.46 Phase 3 Clinical Trial means a clinical trial on a sufficient number of patients that is designed to establish that a Licensed Cell Product is safe and efficacious for its intended use, or to define warnings, precautions and adverse reactions that are associated with the Licensed Cell Product in the dosage range to be prescribed, and to support Regulatory Approval of such Licensed Cell Product.
1.47 Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.
1.48 Product Infringement has the meaning set forth in Section 6.3(a).
1.49 Receiving Party has the meaning set forth in Section 1.11.
1.50 Regulatory Approval means all approvals, including, if applicable, Pricing Approvals, that are necessary for the commercial sale of a Licensed Product in the Field in a given country or regulatory jurisdiction.
1.51 Regulatory Authority means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.
1.52 Regulatory Exclusivity means any exclusive marketing rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity or pediatric exclusivity.
1.53 Representatives means directors, employees, officers, consultants and/or agents of the specified Person.
1.54 Royalty Term has the meaning set forth in Section 4.4(b).