limitation the competitive landscape, the nature and extent of market exclusivity (including without limitation patent coverage and regulatory exclusivity), the likelihood, timing or existence of generic products, technical, legal, scientific, and medical factors, such Products safety and efficacy, its time and cost to develop, the likelihood of regulatory approval, its reasonably expected or actual labeling, its reasonably expected or actual profitability, the amounts of marketing and promotional expenditures with respect to the Product, its reasonably expected or actual pricing, reimbursement and formulary status, and the cost of any studies necessary or reasonably useful to obtain favorable pricing, reimbursement or formulary status for the Product. Commercially Reasonable Efforts may be determined with reference to specific markets or group of markets.
1.3 Confidential Information shall mean any confidential or proprietary information furnished by one party (the Disclosing Party) to the other party (the Receiving Party) in connection with this Agreement, including, without limitation, all specifications, know-how, trade secrets, technical information, drawings, software, models, business information and patent applications pertaining to the Patent Rights, and as further provided in Section 10 hereof.
1.4 FDA shall mean the United States Food and Drug Administration, or any successor agency thereof.
1.5 Field of Use shall mean products and services for human use, including but not limited to the diagnosis, prognosis, prophylaxis and/or treatment of diseases and disorders in humans.
1.6 Funding Agencies shall mean any public or private granting agencies which have provided funding to CSMC or to any of the Inventors for the development of any of the Patent Rights prior to the Effective Date.
1.7 Inventors shall mean [***].
1.8 Patent Rights shall mean CSMCs interest in and to: (a) the patents and/or patent applications which are described on Schedule A of this Agreement, (b) all patents and/or patent applications (including provisional patent applications) in any other country corresponding to any of the foregoing, and all divisions, continuations, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, all claims of continuations-in-part that are entitled to the benefit of the priority date of any of the foregoing, and (c) any patent that issues thereon.
1.9 Product or Products shall mean any product and/or service in the Field of Use that, except for the license granted hereunder, would infringe a Valid Claim.
1.10 Territory shall mean the entire world.
1.11 Valid Claim shall mean a claim of an issued patent included within the Patent Rights, which claim has not (a) lapsed, been canceled or become abandoned, (b) been declared invalid or unenforceable by a non-appealable decision or judgment of a court or other appropriate body or authority of competent jurisdiction, or (c) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise. The term Valid Claim shall also include the claims of a pending patent application within the Patent Rights for a period of [***] years from the actual filing date of that patent application.
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