1.13“Confidentiality Agreement” has the meaning set forth in Section 6.3.
1.14“DACA” has the meaning set forth in Section 5.2(a).
1.15“Development” or “Develop” means, with respect to Purchased Product, the performance of all non-clinical, preclinical and clinical development (including, without limitation, toxicology, pharmacology, test method development and stability testing, process development, formulation development, quality control development, statistical analysis), clinical trials, manufacturing, regulatory activities that are required to obtain and maintain Regulatory Approval of such Purchased Product.
1.16“Disclosing Party” has the meaning set forth in Section 6.1.
1.17“First Commercial Sale Date” the date on which a Selling Party first ships a Purchased Product for commercial sale anywhere in the Territory pursuant to Regulatory Approval; provided, however, that if the sale has occurred in a country for which pricing or reimbursement approval is necessary for widespread sale, then the First Commercial Sale Date shall not occur until the pricing or reimbursement approval has been obtained. Sales for test marketing, sampling and promotional uses, clinical trial purposes, or compassionate or similar use shall not be considered for the First Commercial Sale Date.
1.18“Fiscal Quarter” shall mean each of the three (3) consecutive calendar month periods ending on March 31, June 30, September 30, and December 31.
1.19“Fiscal Year” each of the calendar year periods used by Crystalys for financial reporting, commencing on January 1 and ending on December 31.
1.20“Fuji” means Fuji Yakuhin Co. Ltd.
1.21“Fuji License Agreement” has the meaning set forth in the APA.
1.22“GAAP” means generally accepted accounting principles in the United States in effect from time to time, consistently applied.
1.23“Governmental Authority” means any multi-national, federal, state, local, municipal, or provincial government; any governmental or quasi-governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal); any tribunal, court of competent jurisdiction, administrative agency or commission or other governmental authority or body exercising or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power of any nature (in each case whether federal, state, local, foreign, international or multinational); any Regulatory Authority; or any arbitrator with authority to bind a party at Law.
1.24“Gross Invoice Amount” has the meaning set forth in Section 1.30.
1.25“Indirect Taxes” has the meaning set forth in Section 5.7(c).
1.26“Judgment” means any judgment, order, writ, injunction, citation, award or decree of any nature.
1.27“Laws” means all laws, statutes, rules, regulations, ordinances, codes, consent agreement, requirement, constitution, treaty, writ, injunction, judgment, ruling, decree or order, in each case, having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.
1.28“Lien” means any lien, mortgage, pledge, encumbrance, charge, security interest or charge of any kind or nature whatsoever.