Give me more for this agreement: Source: KITOV PHARMA LTD., 20-F, 3/26/2019
1.4 "Batch" shall mean the defined quantity of the Product processed in a single process or series of processes in a manner designed to be homogeneous. The Batch size for the Product is **** tablets. 1.5 "cGMPs" or "Good Manufacturing Practice" shall mean the part of quality assurance which ensures that the Product is consistently produced and controlled to the quality standards appropriate to their intended use, the principles and guidelines of which are specified in European Commission Directive 2003/94/EC and the FDA's current Good Manufacturing Practices, particularly 21 CFR § 210 et seq., and 21 CFR §§ 600-610, as both may be amended from time to time. 1.6 "Change of Control" shall mean (i) any change, sale, merger, reorganization, or any other event or action that results in a third party, which is a material competitor to the other Party to this agreement, acquiring: (a) all or substantially all of the business or assets of a Party relating to this Agreement, (b) Control, directly or indirectly, of such Party (and/or any corporate entity that Controls, directly or indirectly, such Party), or (ii) any assignment or delegation of, sale or transfer of a Party's rights and obligations under this Agreement (or any part hereof) to a third party. Notwithstanding anything in the immediately preceding paragraph to the contrary, where the Party in question is Dexcel, any of the foregoing events or actions shall not be considered a Change of Control where any one or more of the relevant third party or parties referred to in clause (i) above is (A) a Family Member, or (B) any entity Controlled by Mr. **** and/or a Family Member. 1.7 "Claims" shall mean any demands, claims, actions, causes of action, assessments, losses, damages, injuries, liabilities, costs and expenses (including, without limitation, reasonable attorneys' fees and expenses) filed, raised, initiated or made by any governmental authority and/or third party. 1.8 "Confidential Information" shall have the meaning set forth in Section ​7.1. 1.9 "Confirmed Order" shall have the meaning set forth in Section 3.3.2. 1.10 "Control" or "Controlled" shall mean possession of more than fifty percent (50%) of the share capital of a corporation or other business entity, and/or the power to direct or cause the direction of the management and policies of a corporation or other entity whether through the ownership of voting securities, by contract or otherwise. 1.11 "Delivery" shall mean the time when the Product is placed at the disposal of Kitov at Dexcel's Facility based on an **** (Incoterms® 2010). 1.12 "Distributors" shall mean any Person under contract with Kitov or any of its Affiliates for the distribution of the Product in a certain territory or territories. 1.13 "Effective Date" shall mean the date of signature of the last Party to execute this Agreement. 1.14 "EMA" means the European Medicines Agency or any successor entity. 1.15 "Family Member" shall mean ****. 1.16 "FDA" means the U.S. Food and Drug Administration or any successor entity.
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Source: KITOV PHARMA LTD., 20-F, 3/26/2019
1.17 "Force Majeure" shall mean an event beyond a Party's reasonable control which prevents such Party from performing its obligations hereunder, such events may include, but not be limited to, Acts of God (including fire, flood, earthquake, storm, hurricane or other natural disaster), war, invasion, act of foreign enemies, hostilities (regardless of whether war is declared), civil war, rebellion, revolution, insurrection, military or usurped power or confiscation, terrorist activities, any extraordinary military operation which requires a large military reserve mobilization, nationalization, governmental activities relating to emergency situations, blockage, embargo, strikes or lockouts. 1.18 "Human Trafficking" shall mean the recruitment, transportation, transfer, harboring, or receipt of men, women and/or children by improper means (such as force, abduction, fraud, or coercion) for an improper purpose including forced labor or sexual exploitation. 1.19 "Intellectual Property Rights" shall mean any inventions, information, results, data, hypotheses, discoveries, developments, know- how, production methods, laboratory test results, owned or in the possession of a Party, including, but not limited to, any patent, copyright, registered design, trademarks, trade secrets, or other industrial or intellectual property right, including any and all improvements, enhancements, derivatives and residuals, whether registered or unregistered and applications for any of the foregoing in any country, and any other intellectual property rights. 1.20 "Joint IP" shall have the meaning set forth in Section 8.3 of the Development Agreement as shown in Exhibit A 1.21 "Kitov Data" shall mean, Kitov Foreground IP, including Patent families embodied in Patents applications no. 13/026,741, 12/990,724, WO2009/154944 and WO2011/100659, and Kitov's Confidential Information.. 1.22 "Kitov Foreground IP" shall have the meaning set forth in Section 8.1 of the Development Agreement as shown in Exhibit A. 1.23 "Kitov Product IP" shall have the meaning set forth in Section ​2.1.1. 1.24 "Label", "Labeled" or "Labeling" shall refer to: (i) all labels and other written, printed or graphic matter on the Product or any Packaging utilized with the Product, or (ii) any written material accompanying the Product, including, without limitation, patient information leaflets ("PIL"). 1.25 "Livery" or "Liveries" shall mean the graphics and text appearing on each Pack of the Product, including the Trademark and any logos of Kitov and/or its Distributors, including, inter alia, the requirements for serialization, as notified by Kitov to Dexcel in writing from time to time. 1.26 "Marketing Authorization" shall mean an application to the appropriate Regulatory Authority for approval to market the Product in any particular jurisdiction and all amendments and supplements thereto 1.27 "Minimum Order Requirements" shall mean multiples of a full Batch. 1.28 "Pack" shall mean a bottle containing either **** or **** tablets of the Product, Labeled with the Livery. 1.29 "Packaging" shall mean all primary containers (including bottles or blisters) for the Product, plus cardboard cartons, PILs, shipping cases or any other like matter used in packaging and/or accompanying the Product.