Product Manufacturing Agreement

PartiesDEXCEL LTD. ("Dexcel"), KITOV Pharma Ltd. ("Kitov")("Parties" and individually a "Party")
StateIsrael
SectionCommercial Contracts
Exhibit 4.15
THE SYMBOL “****” DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
PRODUCT MANUFACTURING AGREEMENT
This Product Manufacturing Agreement (“Agreement”) is made as of the Effective Date by and between DEXCEL LTD., with its registered address
at ****, Israel (“Dexcel”) and KITOV Pharma Ltd., with its registered office at 132 Menachem Begin Road, Azrieli Center, Tel Aviv, 6701101, Israel
(“Kitov”). Dexcel and Kitov are hereinafter jointly the “Parties” and individually a “Party.”
WHEREAS: Dexcel is a pharmaceutical company engaged in various activities including, but not limited to, the research, development,
manufacture, and marketing of various drugs and pharmaceutical specialties in various dosage forms;
WHEREAS:Kitov is a pharmaceutical company engaged in various activities including, but not limited to, the development of pharmaceutical
products;
WHEREAS: Kitov and Dexcel entered into a Development Services Agreement on April 1, 2014 (“Development Agreement”), pursuant to which
Dexcel performed certain development services for Kitov with respect to the Product;
WHEREAS: Kitov desires that Dexcel manufacture and package the Product for Kitov in accordance with the terms of this Agreement, and Dexcel
is willing to manufacture and package the Product for Kitov in accordance with the terms of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants herein contained, the Parties, intending to be legally bound, hereby agree as
follows:
1Definitions
For the purpose of this Agreement, the terms set forth in this clause, whether used in singular or plural form, shall mean, unless otherwise expressly
provided for in this Agreement or the context otherwise requires, the following:
1.1 Affiliate” of a Party shall mean any corporation or other business entity directly or indirectly Controlled by, under common Control
with, or in the Control of such Party.
1.2 Anti-Corruption and Anti-Bribery Laws” shall mean the United States Foreign Corrupt Practices Act of 1977, as amended, the
Bribery Act 2010 (2010 Chapter 23) of the Parliament of the United Kingdom, any rules or regulations under such acts, and any other
anti-corruption or anti-bribery statutes, laws or regulations applicable to a Party.
1.3 API” shall mean the active pharmaceutical ingredients Celecoxib and Amlodipine Besylate.
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.
2
Source: KITOV PHARMA LTD., 20-F, 3/26/2019

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