or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting the foregoing, control shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity.
Antibody or Antibodies shall mean a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.
Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.
Combination Product means a product, substance or device which comprises a Licensed Product and at least one Additional Ingredient.
Company Inventions means inventions, developments or improvements owned by Company pursuant to Section 4.2 hereof.
Commercially Reasonable Efforts, with respect to any entity, means those efforts and resources that are commercially reasonable for a company of the same size as such entity with respect to activities in the field of similar therapeutic biologics development.
Consulting Agreement means the Consulting Agreement between [***] and Company of even date herewith, as such agreement may be extended or renewed.
First Commercial Sale means the first sale of a Licensed Product by Company, a Subsidiary of Company or a Sublicensee to an unaffiliated third party, after Regulatory Approval has been achieved in the country in which such Licensed Product is sold. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.
FDA means the United States Food and Drug Administration.
IND means an Investigational New Drug application, as described in 21 C.F.R. Section 312.23, filed for purposes of obtaining FDA approval to conduct Phase I Clinical Trials in accordance with the requirements of the United States Food, Drug and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, including all supplements and amendments thereto applicable to the use of the Licensed Product, or approval of the EMA with respect to comparable activities.
Inventions means all, whether or not patentable, inventions, improvements, discoveries, developments, data, information or results, including laboratory notebooks created by or under the supervision of the Researcher or in his laboratory at the Technion (including, without limitation, by other research staff or students under Researchers supervision or in his laboratory) relating to TCRL, which existed as of March 1, 2005, excluding matter generally known or in the public domain.
Joint Researcher Improvement has the meaning set forth in Section 4.1(b).