voting securities, by contract or otherwise or the ownership either directly or indirectly of 20% (twenty percent) or more of the voting securities of such firm, person or company. 1.2 "Approval" means the grant of all necessary governmental and regulatory approvals required for the marketing, distribution and sale of a pharmaceutical product in any particular country, by a Regulatory Authority, and approvals required for pricing and reimbursements (if appropriate). 1.3 "Bromelain SP" means material derived from pineapple stems, [having the specification as presented in exhibit 1.13] presently manufactured by CBC at the Facility by a special process and used as a raw material in the production of the Product. 1.4 "Conditions Precedent" means the cumulative conditions listed in Section 2.1. 1.5 "Effective Date" shall have the meaning ascribed to such term in Section 2.2. 1.6 "Facility" means CBC's production facility in Tou-Liu City, Yun-Lin Hsien, Taiwan, R.O.C. 1.7 "FDA" means the Food and Drug Administration of the United States Government or any successor thereto. 1.8 "Klein" means Mr. Mark C. Klein. 1.9 "LR" means either or both of L.R. R & D Ltd. and/or Professor Lior Rosenberg. 1.10 "Major Country" means the USA, and the major European and Asian countries listed in Exhibit 1.10 attached hereto. 1.11 "MOU" means the Memorandum of Understanding of January 18, 2000 between MediWound (as assignee of Clal Biotechnology Industries Ltd.), Klein and CBC. 1.12 "Regulatory Authority" means the FDA or similar governmental or other agency in any country having authority to grant Approval. 1.13 "Specifications" means the specifications for Bromelain SP set forth as Exhibit 1.13 hereto, as the same may be amended with the consent of both parties hereto, it being agreed that no amendment may be made thereto or refused which would *** Confidential treatment has been requested for redacted portions of