definiens: means, in respect of any Product, the minimum requirements in a clinical study for the efficacy or safety performance of the Product as set out in the clinical protocol for such study, or, to the extent not specified therein, as may be determined by the JCC prior to the commencement of the clinical study ; 1.1.2 has the meaning set out in Section 13.4 ; 1.1.3 means any Photosensitizer in the Field other than BPD or ZnPc developed by, licensed to, acquired by or otherwise commercially accessible to either party as at the Effective Date or during the term of this Agreement until the Restatement Date and in respect of which the other shall have exercised its right of first refusal in accordance with Section 13 ; 1.1.4 means, with respect to each party, any legal entity that directly or indirectly controls, is controlled by, or is under common control with, such party, but only for so long as such control shall continue . One entity shall be deemed to control another entity if such entity has the power to direct or cause the direction of the management or policies of the other entity ; 1.1.5 means the association formed by [COMPANY] and [COMPANY] for the purposes set out in this Agreement with respect to Products prior to the Transition Effective Date ; 1.1.6 means all laws, statutes, ordinances, codes, rules, and regulations that have been enacted by a supranational, national, or regional, state, provincial or other local government, court, governmental agency, authority, board, bureau, instrumentality, regulatory authority, or other government entity, including without limitation good clinical practices ( ), good laboratory practices ( ), and current good manufacturing practices ( ), and which are in force as of the Effective Date or come into force during the term of this Agreement, in each case to the extent that the same are applicable to the performance by the parties of their respective obligations under this Agreement ; 1.1.7 means in respect of any given country any Product for which Marketing Approval in respect of a specific ophthalmologic indication has been obtained in such country ; 1.1.8 means all the real or personal property, assets and rights used in connection with or by the Alliance from time to time and beneficially owned equally by the parties, including capital assets ; 1.1.9 has the meaning set out in Section 11.1.1 ; 1 * ) Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission . Confidential treatment has been requested with respect to the omitted portions