Document:

exhibit_4-38.htm

Exhibit 4.38

 

Investment and Collaboration Agreement

 

by and between

 

BioLineRx Ltd.

 

and

 

Novartis Pharma AG

 

December 16, 2014

 

  

  

  

[*] Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

Table of Contents

 

	ARTICLE 1 DEFINITIONS	 	 	 	 1
	ARTICLE 2 EQUITY INVESTMENT	 	 	 	 6
	 	2.1 	Equity Investment 	 	 	 	 6
	 	2.2 	Stand-Still Agreement 	 	 	 	 11
	 	2.3 	Trading Restrictions 	 	 	 	 11
	 	2.4 	Information Disclosure 	 	 	 	 12
	 	2.5 	No Representation on Board 	 	 	 	 12
	ARTICLE 3 JOINT STEERING COMMITTEE 	 	 	 	12
	 	3.1 	Joint Steering Committee 	 	 	 	 12
	ARTICLE 4 SCREENING AND PROJECT SELECTION 	 	 	 	 14
	 	4.1 	[*] 	 	 	 	 14
	 	4.2	[*] 	 	 	 	 14
	ARTICLE 5 PRE-IND PROJECTS 	 	 	 	 14
	 	5.1	[*] 	 	 	 	 14
	 	5.2	[*] 	 	 	 	14
	ARTICLE 6 IND PROJECTS 	 	 	 14
	 	6.1	[*] 	 	 	 	 14
	 	6.2	[*] 	 	 	 	 14
	 	6.3	[*] 	 	 	 	 14
	 	6.4	Payment of Option Fee 	 	 	 	 15
	 	6.5	Budget and Funding for Selected Projects 	 	 	 	 15
	 	6.6	Cost Overruns for Selected Projects	 	 	 	 16
	 	6.7	Development Activities for Selected Project	 	 	 	16
	 	6.8	Right of First Negotiation	 	 	 	 16
	 	6.9	[*]	 	 	 	 16
	ARTICLE 7 EXCLUSIVE ARRANGEMENTS 	 	 	16
	 	7.1	Non-Circumvention 	 	 	 	 16
	 	7.2	BioLine Commitment 	 	 	 	 17
	 	7.3	Exclusion of Existing Projects 	 	 	 	 17
	ARTICLE 8 INTELLECTUAL PROPERTY 	 	 	 17
	ARTICLE 9 REPRESENTATIONS AND WARRANTIES 	 	 	 17
	 	9.1	Mutual Representations and Warranties 	 	 	 	17
	 	9.2	Disclaimer 	 	 	 	18
	 	9.3	No Other Representations or Warranties 	 	 	 	 18
	ARTICLE 10 LIABILITY 	 	 	 19
	ARTICLE 11 CONFIDENTIALITY 	 	 	19
	 	11.1	Confidentiality Obligations 	 	 	 	19

 

	
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	 	11.2	Authorized Disclosure 	 	 	 	 20
	 	11.3	Publicity; Use of Names 	 	 	 	 21
	 	11.4	Equitable Relief 	 	 	 	22
	ARTICLE 12 TERM AND TERMINATION 	 	 	 22
	 	12.1	Term 	 	 	 	 22
	 	12.2	Termination for Breach 	 	 	 	 22
	 	12.3	Effect of Termination of the Agreement 	 	 	 	 22
	 	12.4	Survival 	 	 	 	 22
	ARTICLE 13 DISPUTE RESOLUTION 	 	 	 23
	 	13.1	Disputes 	 	 	 	23
	 	13.2	Internal Resolution 	 	 	 	 24
	 	13.3	Binding Arbitration 	 	 	 	 24
	ARTICLE 14 MISCELLANEOUS 	 	 	 24
	 	14.1	Entire Agreement; Amendment 	 	 	 	 24
	 	14.2	Payments and Taxes 	 	 	 	 24
	 	14.3	Force Majeure 	 	 	 	 24
	 	14.4	Notices 	 	 	 	 25
	 	14.5	No Strict Construction; Headings 	 	 	 	 25
	 	14.6	Assignment 	 	 	 	 25
	 	14.7	Performance by Affiliates 	 	 	 	 26
	 	14.8	Further Cooperation by the Parties 	 	 	 	 26
	 	14.9	Severability 	 	 	 	 26
	 	14.10	No Waiver 	 	 	 	 27
	 	14.11	Independent Contractors 	 	 	 	 27
	 	14.12	Expenses 	 	 	 	 27
	 	14.13	No Third Party Beneficiaries 	 	 	 	 28
	 	14.14	English Language 	 	 	 	 28
	 	14.15	Governing Law 	 	 	 	 28
	 	14.16	Construction 	 	 	 	 28
	 	14.17	Counterparts 	 	 	 	 28

 

  

  

  

[*] Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

INVESTMENT AND COLLABORATION AGREEMENT

 

This Investment and Collaboration Agreement (the “Agreement”) is entered into as of December 16, 2014 (the “Effective Date”) by and between Novartis Pharma AG, a corporation organized and existing under the laws of Switzerland and having its principal place of business at Lichtstrasse 35, CH-4056, Basel, Switzerland (“NVS”), and BioLineRx Ltd., a company organized and existing under the laws of the State of Israel and having a principal place of business at 19 Hartum Street, Jerusalem, 91450, Israel (“BioLine”).

 

RECITALS

 

Whereas, BioLine is a clinical-stage biopharmaceutical company developing products for the pharmaceutical market satisfying unmet medical needs or exhibiting advantages over current therapies; and

 

Whereas, NVS is a leading, global pharmaceutical company with extensive experience in the research, development, manufacture, distribution, sales and marketing of pharmaceutical products; and

 

Whereas, NVS and BioLine desire to establish a framework pursuant to which BioLine will grant NVS access to BioLine’s Israel-based drug development pipeline and project screening process with a view to enabling a collaborative approach to continued development of promising pharmaceutical candidates, in accordance with and subject to the terms and conditions set out herein (the “Collaboration”); and

 

Whereas, as an integral part of the Collaboration, NVS desires to make an equity investment in BioLine, all on the terms and conditions set forth herein.

 

Now Therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

ARTICLE 1

Definitions

 

As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural form, shall have the meanings set forth in this Article 1.

 

“ADS” has the meaning set out in Section 2.1.1.

 

“Advisors” has the meaning set out in Section 11.3.1.

 

“Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party.  For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of 50% or more of the voting stock of such entity, or by contract or otherwise.

 

	
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“BioLine” means BioLineRx Ltd., as further defined in the Preamble above.

 

“Change of Control” means a transaction which results in a change in the power to direct (directly or indirectly) the management and policies of BioLine through the ownership of voting capital, by which (i) any person or group becomes the beneficial owner of voting securities (including any options, rights or warrants to purchase, and any securities convertible into or exchangeable for, voting securities) of BioLine representing 50% or more of the voting power represented by all outstanding securities of BioLine; or (ii) a majority of the seats on the board of directors of BioLine shall at any time be occupied by persons who were not members of the board of directors prior to such transaction.

 

“Clinical Proof of Concept” means the conclusion of the first clinical study in healthy human volunteers or patients showing safety, tolerability, pharmacodynamic activity, pharmacokinetics, early evidence of efficacy, generally equivalent to a Phase I study pursuant to FDA regulations or foreign equivalents, as well as evidence of drug metabolism and mechanism of action, all as specifically agreed by the Parties during the process of establishing the Core Terms.

 

“Closing Price Per ADS” has the meaning set out in Section 2.1.

 

“Collaboration” has the meaning set out in the Preamble above.

 

“Collaboration Quota” means the presentation by BioLine to NVS at the Joint Steering Committee of seven projects, each of which is either: (a) an IND Project; or (b) a Pre-IND Project with respect to which NVS has exercised Matching Rights, where such project has been sublicensed by BioLine to NVS pursuant to the arrangements set out in Section 5.2.5.

 

“Confidential Information” means, with respect to a Party, all reports and other Information of such Party that is disclosed to the other Party pursuant to the arrangements set out in this Agreement, whether in oral, written, graphic, or electronic form.  All Information disclosed by a Party pursuant to the Mutual Non-Disclosure Agreement between the Parties dated May 7, 2014, as amended through the Effective Date, shall be deemed to be such Party’s Confidential Information disclosed hereunder.

 

“Core Term Memorandum” has the meaning set out in Section 6.3.3.

 

“Core Terms” has the meaning set out in Section 6.3.

 

“CSR” has the meaning set out in Section 6.8.

 

“Development Budget Balance” has the meaning set out in Section 6.5.1.

 

“Dollar” means the U.S. dollar, and “$” shall be interpreted accordingly.

 

	
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“Effective Date” means the date on which this Agreement becomes effective, as set out in the Preamble above.

 

“EMA” means the European Medical Agency and any successors thereof.

 

“Executive” means a senior executive of a Party, such as, by way of example, a Party’s Chief Executive Officer or the chairman of the Board of Directors of such Party.

 

“FDA” means the United States Food and Drug Administration and any successors thereof.

 

“Flagged Project” has the meaning set forth in Section 5.2.1.

 

“Form 6-K” shall mean that form administrated by the SEC and submitted by foreign private issuers of securities pursuant to certain rules promulgated under the Securities Exchange Act of 1934.

 

“Form 20-F” shall mean the most recent annual report filed by BioLine with the SEC on Form 20-F.

 

“Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

 

“In-Person Meeting” has the meaning set forth in Section 3.1.4.

 

“IND” means an Investigational New Drug Application pursuant to the regulations and guidelines of the FDA, or a comparable application pursuant to the regulations and guidelines of the EMA, the Israel Ministry of Health or another Regulatory Authority.

 

“IND Project” means a project that is included in the Collaboration and that (i) is IND-ready, or (ii) with respect to which human clinical data has been generated, whether by BioLine or a Third Party, or (iii) is otherwise deemed to be an IND Project in accordance with Section 5.3.

 

“IND-ready” means a project that is of such a stage of development that it is ready for IND submission pursuant to regulations of the Regulatory Authority to which it is to be submitted, as mutually agreed by the Parties.

 

“Information” means any data, results, technology, business information and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, test data (including pharmacological, biological, chemical, biochemical, toxicological, preclinical and clinical test data), manufacturing know-how and data, analytical and quality control data, stability data, other study data and procedures.

 

“Investment Date” has the meaning set forth in Section 2.1.

 

	
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“JDT” or “Joint Discussion Team” has the meaning set forth in Section 3.1.6.

 

“Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.1.1.

 

“Key Employee” means a senior executive of BioLine.

 

“Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign, or of any Governmental Authority .

 

“Matching Rights” has the meaning set forth in Section 5.2.5.

 

“Material Adverse Change” has the meaning set forth in Section 2.1.4(c).

 

“Matching Rights Notice” has the meaning set forth in Section 5.2.4.

 

“Net Consideration” has the meaning set forth in Section 6.9.5.

 

“NIBR” means Novartis Institutes of BioMedical Research.

 

“Non-Breaching Party” has the meaning set forth in Section 12.2.1.

 

“Non-Israel Sourced Projects” has the meaning set forth in Section 4.1.

 

“Notified Party” has the meaning set forth in Section 12.2.1.

 

“NVS” means Novartis Pharma AG, as further defined in the Preamble above.

 

“NVS Engagement Contributions” has the meaning set forth in Section 5.2.1(i).

 

“Option Fee” has the meaning set forth in Section 6.4.

 

“Option Fee Repayment Amount” has the meaning set forth in Section 6.9.5.

 

“Ordinary Shares” has the meaning set forth in Section 2.1.1.

 

“Partial Release Date” has the meaning set forth in Section 2.3.1.

 

“Party” means either NVS or BioLine, and “Parties” means both NVS and BioLine, collectively.

 

“POC Endpoints” has the meaning set out in Section 6.3.1.

 

“Pre-existing NVS IP” means intellectual property and rights therein and thereto owned or controlled by NVS and/or its Affiliates prior to the Effective Date, and/or developed by NVS and/or its Affiliates subsequent to the Effective Date but outside the scope of the Collaboration.

 

“Pre-IND Project” means a project that is included in the Collaboration and (i) that is not IND-ready or (ii) with respect to which no human clinical data has been generated.

 

	
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“Project” means either a Pre-IND Project or an IND Project, as the context requires, which is included in the Collaboration, and “Projects” means Pre-IND Projects and IND Projects, collectively.

 

“Project IP” has the meaning set out in Article 8.

 

“Regulatory Approval” means, with respect to a pharmaceutical product, all approvals, registrations, licenses or authorizations from the relevant Regulatory Authority, in any country or jurisdiction, that is specific to such product and necessary to manufacture, market and/or sell such product.

 

“Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority responsible for granting Regulatory Approval.  Without limiting the generality of the foregoing, the FDA, EMA and the Israel Ministry of Health are Regulatory Authorities in their respective jurisdictions.

 

“Rejected Pre-IND Project” has the meaning set out in Section 5.1.

 

“Restricted Period” has the meaning set out in Section 5.2.3.

 

“ROFN” has the meaning set out in Section 6.8.

 

“ROFN Period” has the meaning set out in Section 6.8.

 

“Screen B Projects” has the meaning set out in Section 4.1.

 

“SEC” means the U.S. Securities Exchange Commission.

 

“Securities Act” has the meaning set out in Section 2.1.2.

 

“Selected Project” has the meaning set out in Section 6.3.3.

 

“Selected Project Selection Date” has the meaning set out in Section 6.3.3.

 

“Stand-Still Agreement” has the meaning set out in Section 2.2.

 

“Sublicense Agreement” shall mean the agreement pursuant to which BioLine will grant to NVS, or another mutually agreed Affiliate of NVS, to the maximum extent possible, the exclusive, worldwide, sublicenseable right and license to exploit technology, know-how and other forms of intellectual property that BioLine has previously in-licensed from a Third Party (including by way of conducting further research and development of the licensed technology, and the manufacture, marketing, distribution and/or sale of products based on such technology, know-how and intellectual property) with respect to a Flagged Project or a Selected Project.

 

“Term” means the term of this Agreement, as determined in accordance with Section 12.1.

 

“Third Party” means any person or entity other than BioLine or NVS or an Affiliate of either of them.

 

	
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“Third Party Opportunity” has the meaning set out in Section 5.2.4

 

“Third Party Transaction” has the meaning set out in Section 6.9.5.

 

[*]

 

[*]

 

has the meaning set out in Section 6.9.

 

“VWAP” means the volume-weighted average trading price of BioLine’s ADSs on the Nasdaq.

 

ARTICLE 2

Equity Investment

 

2.1           Equity Investment.  Within ten days of the Effective Date, NVS shall make an initial $10 million equity investment in American Depositary Shares (“ADS”) of BioLine at a price per ADS based on the higher of (i) $2.00 per ADS; or (ii) a 20% premium over the VWAP, as reported on the Nasdaq, for the 30-day period ending on the day prior to the Effective Date; or (iii) a 10% premium over the closing price of BioLine’s ADSs on the trading day immediately prior to the Effective Date (the “Closing Price Per ADS”) as reported on the Nasdaq; provided however, that if the Closing Price Per ADS is less than $1.40, the price per ADS to be paid by NVS will be as set forth in the column captioned “Price per ADS to NVS” on the schedule set forth as Exhibit 2.1.  The date upon which the equity investment is made shall be referred to as the “Investment Date”.  In connection with the equity investment:

 

2.1.1           Authorization of Ordinary Shares.  BioLine has authorized the issuance and sale of (i) 50,000,000 ordinary shares, par value NIS 0.01 per share (“Ordinary Shares”), represented by 5,000,000 American Depositary Shares (the “ADSs”).  For purposes of clarification, each ADS represents ten Ordinary Shares.

 

2.1.2           Completion of Investment.  The completion of the equity investment shall occur on the Investment Date at the offices of Yigal Arnon & Co., One Azrieli Center, Tel Aviv, 6133701, Israel.  At the completion, NVS shall deliver, in immediately available funds, the full amount of the purchase price for the ADSs being purchased hereunder by wire transfer to an account designated by BioLine, and BioLine shall, within three business days, deliver to NVS a certificate registered in the name of NVS, or in such nominee name as designated by NVS in writing, representing the number of ADSs set forth in Section 2.1.1 above.  The issue and sale to NVS will comply with Rule 903 of Regulation S under the Securities Act of 1933, as amended (the “Securities Act”) and the certificates will bear an appropriate legend referring to that fact.

 

2.1.3           NVS Representations.  In connection with the purchase of the ADSs, NVS represents and warrants to, and covenants with BioLine that:

 

  (a)           Experience.  (i) NVS is knowledgeable, sophisticated and experienced in financial and business matters, and is qualified to make decisions with respect to investments in shares representing an investment decision like that involved in the purchase of the ADSs, has the ability to bear the economic risks of an investment in the ADSs and has requested, received, reviewed and considered all information it deems relevant in making an informed decision to purchase the ADSs; (ii) NVS is acquiring the ADSs for its own account with no present (as of the Effective Date) intention of distributing any of such ADSs or entering into any arrangement or understanding with any other persons regarding the distribution of such ADSs; and (iii) NVS will not, directly or indirectly, offer, sell, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the ADSs, nor will NVS engage in any short sale that results in a disposition of any of the ADSs by NVS, except in compliance with Sections 2.2 and 2.3 hereof, the Securities Act, the Israeli Securities Law, and the rules and regulations promulgated thereunder and any applicable state securities laws.

 

	
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  (b)           U.S. exemption. (i) NVS is aware that the sale of the ADSs has not been registered under the Securities Act or any state securities laws or regulations in reliance upon Regulation S and similar exemptions under state law, (ii) NVS will not offer or sell the Shares unless they are registered or are exempt from registration under the Securities Act and any applicable state securities laws or regulation; (iii) NVS is not a U.S. Person (as that term is defined in Regulation S) nor acquiring the Shares for the account or benefit of any U.S. Person; and (iv) this Agreement has not been executed or delivered by NVS in the United States.

 

  (c)           Risk of Loss.  NVS understands that its investment in the ADSs involves a significant degree of risk, including a risk of total loss of NVS’s investment, and NVS has full cognizance of and understands all of the risk factors related to the NVS’s purchase of the ADSs.  NVS understands that the market price of the ADSs has been volatile and that no representation is being made as to the future value of any of the ADSs.

 

2.1.4           BioLine Representations.  In connection with the equity investment, and in addition to the representations and warranties made by BioLine under Section 9.1 below, BioLine represents and warrants to, and covenants with NVS that:

 

  (a)           Authorization of the ADSs.  The Ordinary Shares represented by the ADSs have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by BioLine pursuant to this Agreement, will be validly issued, fully paid, and non-assessable and free and clear of all liens, encumbrances, preemptive rights and other claims.

 

  (b)           Capitalization and Other Capital Stock Matters.  The authorized, issued, and outstanding share capital of BioLine conformed in all material respects to the description thereof contained in the Form 20-F and any Forms 6-K filed or furnished subsequent thereto, in each case as of the date of such Form 6-K.  All of the issued and outstanding Ordinary Shares have been duly authorized and validly issued, are fully paid and non-assessable and have been issued in compliance with applicable Israeli, U.S. federal and state securities laws.  None of the outstanding Ordinary Shares were issued in violation of any preemptive rights, rights of first refusal, or other similar rights to subscribe for or purchase securities of BioLine.  There are no authorized or outstanding options, warrants, preemptive rights, rights of first refusal, or other rights to purchase, or equity or debt securities convertible into, exchangeable or exercisable for, any share capital of BioLine other than those described in the Form 20-F or any Form 6-K filed or furnished subsequent thereto.

 

	
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  (c)           No Actions.  There is no legal or governmental action, suit or proceeding pending or, to the knowledge of BioLine, threatened against or affecting BioLine or any of its directors and officers in their capacities as such, which has as the subject thereof any officer or director of, or property owned or leased by, BioLine that would reasonably be expected to result in a material adverse change to BioLine’s business, financial position, or results of operations taken as a whole (a “Material Adverse Change”) or adversely affect the consummation of the transactions contemplated hereby.

 

  (d)           Financial Statements.  The financial statements and the related notes thereto of BioLine and its consolidated subsidiaries included in the most recent Form 20-F comply as to form in all material respects with the applicable requirements of Regulation S-X under the Securities Act and present fairly in all material respects the financial position, results of operations and cash flows of BioLine as of the dates indicated and for the periods specified; such financial statements have been prepared in conformity with the International Financial Reporting Standards (“IFRS”) applied on a consistent basis throughout the periods covered thereby.

 

  (e)           SEC Filings. BioLine is subject to and in compliance in all material respects with its United States and Israeli reporting requirements and has filed all reports required to be filed by it on a timely basis. As of their respective dates, all SEC reports filed by BioLine complied in all material respects with Laws and the rules and regulations of the SEC.

 

  (f)            NASDAQ. BioLine is in compliance with applicable Nasdaq continued listing requirements, and to BioLine’s knowledge there are no proceedings pending or threatened against BioLine to revoke or suspend such listing. BioLine has not received any notice of delisting from Nasdaq and has no knowledge of any facts or circumstances which would reasonably be expected to lead to delisting or suspension.

 

  (g)           Agreements. Except as disclosed in its SEC filings, there are no agreements, understandings, instruments, contracts or proposed transactions to which BioLine is a party or by which it is bound that involve (i)  the license of any patent, copyright, trademark, trade secret or other proprietary right to or from BioLine, (ii) the grant of rights to manufacture, produce, assemble, license, market, or sell products to any other person that limit BioLine’s exclusive right to develop, manufacture, assemble, distribute, market or sell its products, or (iii) indemnification by BioLine with respect to infringements of proprietary rights.

 

  (h)           Intellectual Property. BioLine owns or possesses or can acquire on commercially reasonable terms sufficient legal rights to all BioLine intellectual property necessary to conduct its business as described in its SEC filings without any known conflict with, or infringement of, the rights of others.  To BioLine’s knowledge, no product or service developed, marketed or sold (or proposed to be developed, marketed or sold) by BioLine violates or will violate any license or infringes or will infringe any intellectual property rights of any other party.  Except as disclosed in its SEC filings, there are no outstanding options, licenses, agreements, claims, encumbrances or shared ownership interests of any kind relating to BioLine’s intellectual property, nor is BioLine bound by or a party to any options, licenses or agreements of any kind with respect to the patents, trademarks, service marks, trade names, copyrights, trade secrets, licenses, information, proprietary rights and processes of any other person.  BioLine has not received any communications alleging that BioLine has violated, or by conducting its business, would violate any of the patents, trademarks, service marks, tradenames, copyrights, trade secrets, mask works or other proprietary rights or processes of any other person.  Each employee and consultant engaged in the development of intellectual property rights has assigned to BioLine all intellectual property rights he or she owns that are related to BioLine’s business as now conducted and as presently proposed to be conducted.

 

	
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  (i)            Employees.  To BioLine’s knowledge, none of its Key Employees is obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would materially interfere with such Key Employee’s ability to promote the interest of BioLine or that would conflict with the BioLine’s business.  To BioLine’s knowledge, no employee intends to terminate employment with BioLine or is otherwise likely to become unavailable, nor does BioLine have a present intention to terminate the employment of any of the foregoing.  There is no labor dispute involving BioLine pending, or to BioLine’s knowledge, threatened.

 

  (j)            Compliance with Other Instruments. Except as disclosed in SEC filings, BioLine is not in violation or default (i) of any provisions of its certificate of incorporation or bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) under any note, indenture or mortgage, or (iv) under any lease, agreement, or contract to which it is a party, or (v) of any material provision of federal or state Law applicable to BioLine except in each case for such violations which would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Change.  The execution, delivery and performance of this Agreement will not result in any such violation or be in conflict with or constitute, with or without the passage of time and giving of notice, either (i) a default under any such provision, instrument, judgment, order, writ, decree, contract or agreement; or (ii) an event which results in the creation of any lien, charge or encumbrance upon any assets of BioLine or the suspension, revocation, forfeiture, or nonrenewal of any material permit or license applicable to BioLine, except for any such default or event which would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Change.

 

  (k)           Litigation. Except as disclosed in SEC filings, there is no action, suit or proceeding, or governmental inquiry or investigation, pending or, to the knowledge of BioLine, threatened against BioLine or any officer, director or employee of BioLine, and, to BioLine’s knowledge, there is no basis for any such action, suit, proceeding, or governmental inquiry or investigation.  Neither BioLine nor, to BioLine’s knowledge, any of its officers, directors or employees is a party or is named as subject to the provisions of any order, writ, injunction, judgment or decree of any court or governmental authority that would reasonably be expected to result in a Material Adverse Change.

 

  (l)            Certain Transactions. Except as disclosed in SEC filings, BioLine is not indebted, directly or indirectly, to any of its directors, officers or employees or to their respective spouses or children or to any Affiliate of any of the foregoing, other than for customary employee benefits made generally available to all employees.  To BioLine’s knowledge, none of BioLine’s directors, officers or Key Employees, or any members of their immediate families, or any Affiliate of the foregoing are, directly or indirectly, indebted to BioLine or, to BioLine’s knowledge, have any direct or indirect ownership interest in any firm or corporation with which BioLine is affiliated or with which BioLine has a business relationship, or any firm or corporation which competes with BioLine except that directors, officers, Key Employees or stockholders of BioLine may own stock in (but not exceeding two percent (2%) of the outstanding capital stock of) publicly traded companies that may compete with BioLine.

 

	
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  (m)           Officers. To BioLine’s knowledge, no officer or person nominated to become an officer of BioLine (i) has been convicted in a criminal proceeding or is a named subject of a pending criminal proceeding (excluding minor traffic violations) or (ii) is, or has been, subject to any judgment or order of, or the subject of, any pending civil or administrative action by the SEC or any self-regulatory organization.

 

  (n)           Property. BioLine has good and marketable title (in the case of real property) to, or has valid rights to lease or otherwise use, all items of real and personal property and assets that are material to its business, free and clear of all liens, encumbrances, claims and defects and imperfections of title except those that (i) do not materially interfere with the use made and proposed to be made of such property by BioLine or (ii) would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change.

 

  (o)           Insurance.  BioLine has in full force and effect fire and casualty insurance policies with extended coverage, which it reasonably believes to be sufficient in amount (subject to reasonable deductions) to allow it to replace any of its properties that might be damaged or destroyed.

 

  (p)           Permits. BioLine has all franchises, permits, licenses and any similar authority necessary for the conduct of its business except where the lack of such franchises, permits, licenses and any similar authority would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.  BioLine is not in default under any of such franchises, permits, licenses or other similar authority where such default would reasonably be expected to result in a Material Adverse Change.

 

  (q)           Environmental and Safety Laws. To BioLine’s knowledge and except as disclosed in SEC filings, (a) it is and has been in material compliance with all applicable environmental laws; and (b) there has been no release or to BioLine’s knowledge threatened release of any pollutant, contaminant or toxic or hazardous material, substance or waste or petroleum or any fraction thereof, on, upon, into or from any site currently or heretofore owned, leased or otherwise used by BioLine except for any such matter, as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

 

  (r)            Disclosure. The representations and warranties of BioLine contained in this Agreement are true and correct as of the date hereof.

 

	
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2.2           Stand-Still Agreement.  The Parties agree to be bound by the following “stand-still” provisions (the “Stand-Still Agreement”). During the Term, NVS agrees that it will not, and will cause each of its Affiliates or agents or other persons acting on its behalf not to:

 

2.2.1           without the prior written agreement of BioLine, acquire, offer to acquire or agree to acquire, alone or in concert with any other individual or entity, by purchase, tender offer, exchange offer, agreement, merger, business combination or any other manner, beneficial ownership of any securities of BioLine, if, after completion of such acquisition or proposed acquisition, the aggregate beneficial ownership of NVS and its Affiliates shall be more than [*]% of the outstanding Ordinary Shares of BioLine (calculated based on the issued and outstanding share capital of BioLine as of the completion of such acquisition); provided, however, that such limitation shall not apply to shares acquired directly pursuant to stock dividends or similar distributions of Ordinary Shares made on a pro rata basis to all holders of Ordinary Shares or ADSs;

 

2.2.2           submit any stockholder proposal or any notice of nomination of director candidates or notice of any other business for consideration, or nominate any director candidate for election to the Board or withhold authority for or oppose any director candidates nominated by the board of directors of BioLine;

 

2.2.3           call, seek to call, or to request the calling of, a special meeting of the stockholders of BioLine, or seek to make, or make, a stockholder proposal at any meeting of the stockholders of BioLine, alone or in concert with others, seek to control or influence the governance, affairs, business, management or policies of BioLine; or

 

2.2.4           enter into any agreements, arrangements, commitments, plans or understandings (whether written or oral) with, or advise, finance, assist or knowingly encourage, any other person that engages, or offers or proposes to engage, in any of the foregoing.

 

2.3           Trading Restrictions.  NVS agrees that, without the prior written consent of BioLine:

 

2.3.1           All ADSs issued to NVS in consideration for the investment made pursuant to Section 2.1 shall be subject to a lockup restriction until the earlier of: (a) [*] months following such issuance and (b) the payment by NVS of an Option Fee as set out in Section 6.4 below (such date, a “Partial Release Date”).  Following a Partial Release Date, NVS shall be entitled to sell the greater of: (x) [*]% of the ADSs held by NVS prior to the issuance of new ADSs as a result of payment of an Option Fee; and (y) the total number of ADSs issued to NVS in connection with the payment of the aforesaid Option Fee, in both cases subject to the restrictions set out in Sections 2.3.2 through 2.3.5.  All remaining ADSs shall remain subject to the lockup for the full Term of this Agreement.

 

2.3.2           During the Term, NVS shall not sell more than [*]% of its holdings in BioLine during any rolling 6-month calendar period, based on the holdings existing at the beginning of such 6-month period.

 

2.3.3           On no single day during the Term of this Agreement will NVS sell more than [*]% of the daily share trading volume of BioLine’s ADSs on Nasdaq.

 

2.3.4           For a period of one year following the termination of this Agreement, on no single day will NVS sell more than [*]% of the Nasdaq daily share trading volume of BioLine’s ADSs; provided, however, that upon termination of this Agreement under Section 12.2 by NVS for breach by BioLine and/or a Change of Control of BioLine, NVS will be released from such restrictions set forth above.

 

	
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2.3.5           For clarification, where ADSs are subject to a lock up restriction or a restriction on “sale” as stated in Subsections 2.3.1 through 2.3.4, then NVS shall not (1) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any ADSs or Ordinary Shares or any securities convertible into or exercisable or exchangeable for ADSs or Ordinary Shares, (2) enter into any swap or other agreement that transfers, in whole or in part, any of the economic consequences of ownership of the ADSs or Ordinary Shares or such other securities of the Company, or (3) make any demand for or exercise any right with respect to the registration of any ADSs or Ordinary Shares or any security convertible into or exercisable or exchangeable for Ordinary Shares without the prior written consent of BioLine, in each case other than (a) transactions relating to ADSs acquired in open market transactions (not in violation of the Stand-Still Agreement) other than pursuant to this Agreement; or (b) transfers of ADSs to entities which are Affiliates of NVS.

 

2.4           Information Disclosure.  BioLine will update NVS, as may be reasonable and appropriate in the circumstances in light of the Collaboration, with respect to the following material corporate developments or decisions of the Board of Directors of BioLine (aside from matters related to partnering or potential partnering with Third Parties, which BioLine will not be required to disclose to NVS): (a) ongoing financial condition of BioLine on a quarterly basis (such as general budget, cash and cash forecasts); (b) material financing activities; (c) material decisions regarding projects (such as closing projects and increasing investment significantly in projects); (d) in-licensing of projects to BioLine (other than through the Collaboration); and (e) major human resource issues.  The foregoing updates will be provided to NVS on the condition that any material non-public information provided by BioLine to NVS hereunder will result in a “black-out period” (the scope of which will be defined by BioLine’s General Counsel in his or her sole discretion) during which period NVS will be restricted from trading in BioLine shares.

 

2.5           No Representation on Board.  For clarity, NVS will not be entitled to appoint a director on, or observer to, BioLine’s board of directors.

 

ARTICLE 3

Joint Steering Committee

 

3.1           Joint Steering Committee.

 

3.1.1           Formation and Purpose.  Within 30 days of the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to oversee, implement and coordinate the Collaboration established pursuant to this Agreement.  The JSC shall, inter alia, evaluate projects presented by BioLine and decide whether to proceed with further development thereof and on what terms, and shall generally be a forum for consultation and information exchange.

 

	
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3.1.2           Members.  Each of BioLine and NVS shall appoint representatives to the JSC, each of whom will have sufficient seniority and expertise within the applicable party to make decisions arising within the scope of the JSC’s responsibilities.

 

  (a)           NVS Representatives.  The initial NVS representatives shall be: [*].

 

  (b)           BioLine Representatives.  The initial BioLine representatives shall be:[*].

 

  (c)           Replacements.  Each Party may replace its JSC representatives at any time upon written notice to the other Party.

 

  (d)           Attendance by Non-Members.  Each Party may also invite non-members to participate in the discussions and meetings of the JSC on an ad hoc basis where appropriate (e.g., representatives from regulatory, IP, commercial, franchise/business units, as well as corporate executives), subject to such individuals being subject to reasonable and customary binders of confidentiality).  For clarity, non-member shall have no voting authority at the JSC.

 

3.1.3           Chairperson.  The JSC shall have a chairperson, who shall serve for a term of one year, and who shall be selected alternately, on an annual basis, by BioLine or NVS.  The initial chairperson shall be selected by NVS.  The role of the chairperson shall be to convene and preside at meetings of the JSC and to ensure the preparation of minutes, but the chairperson shall otherwise have no additional powers or rights beyond those held by the other JSC representatives.

 

3.1.4           Meetings.  The JSC shall meet at least once every 2 months during the Term to evaluate and discuss new opportunities, review any Flagged Projects, and address the progress and implementation of the Collaboration, as well as various matters addressed herein as applicable.  The Parties may mutually agree in writing to a different frequency for such meetings; provided that there should be a face-to-face in-person meeting at least three times per year at a location and time agreed by the Parties (the “In-person Meeting”).  No later than 10 days prior to any scheduled meeting of the JSC, the chairperson of the JSC shall prepare and circulate an agenda for such meeting and, as soon as practicable, materials for the meeting; provided, however, that either Party may propose additional topics to be included on such agenda prior to such meeting.  The JSC may meet in person, by video conference or by teleconference (except for the In-person Meetings which shall be in-person).  Meetings of the JSC shall be effective only if at least one representative of each Party is present or participating in such meeting.  The chairperson of the JSC will be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect, without limitation, material decisions made at such meetings.  The JSC chairperson shall send draft meeting minutes to each member of the JSC for review within 15 days after each JSC meeting.  The members of the JSC shall then have 15 days to provide comments.  The JSC chairperson shall incorporate timely received comments and distribute revised minutes to all members of the JSC for their final review and approval by the later of 45 days after the relevant meeting or the next regularly scheduled meeting of the JSC.

 

	
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3.1.5           Decision-Making.  Unless otherwise set forth in this Agreement or as may be mutually agreed by the Parties, the JSC will take action by unanimous consent, with each Party’s representatives’ (collectively) having a single vote on the JSC, irrespective of the number of representatives actually in attendance at a meeting (i.e., a total of two votes).

 

3.1.6           Joint Discussion Teams.  Once a Project is brought into the Collaboration such that the JSC decides to pursue its further development in accordance with one of the mechanisms set out in this Agreement, the JSC will establish a Joint Discussion Team (“JDT”) with representatives from the Parties (who may, but need not, be members of the JSC) to provide ongoing practical input into and oversee the initial development of the applicable Project.  There will be a JDT for each Project.  The JDT will meet at least quarterly and in addition ad hoc on an “as needed” basis.  The JDT will report regularly to the JSC.  The JDT is intended to serve in an advisory capacity only, and will not have decision-making authority unless otherwise agreed in writing by the representatives of the Parties on the JSC.

 

3.1.7           Costs.  The Parties agree that the costs incurred by each Party in connection with its travel to and participation in the JSC and the JDT shall be borne solely by such Party.

 

3.1.8           Discontinuation of JSC.  The JSC shall continue to exist throughout the Term unless the Parties mutually agree to disband the JSC.

 

ARTICLE 4

Screening and Project Selection

 

4.1           [*]

 

4.2           [*]

 

ARTICLE 5

Pre-IND Projects

 

5.1           [*]

 

5.2           [*]

 

5.3           [*]

 

ARTICLE 6

IND Projects

 

6.1           [*]

 

6.2           [*]

 

6.3           [*]

 

	
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6.4           Payment of Option Fee.  Within 60 days following (i) the Selected Project Selection Date, and (ii) receipt by NVS of an invoice in the form attached as Exhibit 6.4 attached hereto (subject to BioLine holding the license to the relevant project from the relevant IP owner at such time), NVS shall pay BioLine a non-refundable $5 million option fee (the “Option Fee”).  Notwithstanding anything to the contrary herein, upon payment by NVS of the Option Fee and continuing through the end of the ROFN Period, the arrangements and restrictions set out in Section 6.8 shall apply with respect to the applicable Selected Project.

 

6.5           Budget and Funding for Selected Projects.  The budget for each Selected Project would be funded as follows:

 

6.5.1           50% of the balance of the agreed development budget (after taking into account the Option Fee) (the “Development Budget Balance”) will be provided by NVS in the form of an equity investment in the ADSs of BioLine.  The equity investment will be made no later than 30 days following the Selected Project Selection Date at a price per ADS reflecting a 5% premium over the VWAP, as reported on the Nasdaq, for the 10-day period ending on the day prior to the Project Selection Date.  The terms and provisions of Section 2.1 and 2.3 above shall apply, mutatis mutandis, to the aforesaid investment.  Notwithstanding the foregoing, BioLine will have the option to request that such funding be made in the form of debt, including convertible debt on terms that are to be agreed at the time, or in any other form as will be agreed by the Parties.

 

6.5.2           BioLine will be responsible for funding the remaining 50% of the Development Budget Balance for the Selected Project.

 

6.5.3           The budget will include all expenses related to the continued development activities for the Selected Project, including expenses for dedicated employees and consultants, as well as IP-related expenses, but will not include specific non-project-related expenses such as overhead costs incurred by either of the Parties.  The budget will also include a reserve equal to at least 25% of the total of all other items in the budget, for cost-overruns, or as otherwise mutually agreed by the Parties.

 

6.6           Cost Overruns for Selected Projects.  The following arrangements shall apply to cost overruns that may arise during the course of performing the development activities for a Selected Project:

 

6.6.1           If the costs exceed the agreed budget by up to [*]%, the Parties will fund such excess on an equal basis; provided, however, that where the costs exceed the agreed budget by [*]% or more, the Parties will have the option to choose whether they want to continue with the agreed development plan (as included in the Core Terms) or modify it.  If both Parties agree to modify the development plan and agree on the allocation of costs with respect thereto (whether on an equal basis or otherwise), then the development plan and budget will be amended accordingly and the Selected Project will continue in accordance therewith.

 

6.6.2           If there is no agreement on modifying the development plan and the related allocation of costs, the Parties may either negotiate a new arrangement with respect to the Selected Project, including a new development plan and related budget, or the Party supporting the increase in the budget may elect to (i) assume the additional costs in excess of what the Party not supporting the increase is willing to fund - in which event the Selected Project shall continue, or (ii) stop its investment in the project - in which event the Selected Project shall cease to be included in the Collaboration, and BioLine shall be free to proceed with the development and commercialization thereof without any further obligation to NVS (subject, however, to BioLine’s obligation to pay NVS the Option Fee Repayment Amount pursuant and subject to the arrangements in Section 6.9.5 below).

 

	
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6.6.3           Notwithstanding anything to the contrary herein, neither Party will be required, without its prior agreement, to accept a budget for a Selected Project which exceeds the agreed budget by more than [*]%.

 

6.7           Development Activities for Selected Project.  BioLine will retain full control over the development process of Selected Projects until the execution of a Sublicense Agreement with respect thereto; provided, however, BioLine and NVS shall continue to consult on the progress of the implementation of the development plan for the Selected Project via the JDT.

 

6.8           Right of First Negotiation. At least six months prior to the expected availability of the draft clinical study report in respect of the Clinical Proof of Concept study defined in the Core Terms (the “CSR”) BioLine shall notify NVS in writing as to the expected date of sending the draft CSR with respect to a Selected Project.  Upon receipt of such notice, NVS shall be entitled to access all due diligence materials for the Selected Project.  For each Selected Project, NVS shall have a right of first negotiation (meaning, for the purpose of clarity, that BioLine will not actively solicit research, collaboration, co-development, commercialization, licensing or other similar opportunities with Third Parties) (“ROFN”) for a period of time commencing on the Selected Project Selection Date (in accordance with Section 6.3) and continuing until the later to occur of (i) the expiration of 4 months following the presentation to NVS of the draft CSR with respect to such Selected Project, and (ii) the expiration of 30 days following the presentation to NVS of the final CSR with respect to such Selected Project (the “ROFN Period”).  NVS shall have the right, at any time during the ROFN Period, to commence a period of exclusive negotiations to obtain, to the maximum extent possible, an exclusive, sublicenseable, worldwide sublicense to develop, manufacture, exploit, sell and otherwise commercialize products based on, arising from and/or related to the particular Selected Project, by providing a good faith non-binding term sheet to BioLine, in which case the Parties will in good faith negotiate the terms of a definitive Sublicense Agreement.  If no definitive Sublicense Agreement has been entered into prior to the end of the ROFN Period (or any longer period that may be agreed in writing between the Parties), then BioLine shall be entitled, without notice to NVS, to pursue Third Party Opportunities with respect to such Selected Project; [*]

 

6.9           [*]

 

ARTICLE 7

Exclusive Arrangements

 

7.1           Non-Circumvention.  Subject to the terms and conditions set out in this Article 7, except as otherwise set out in this Agreement, the arrangements between BioLine and NVS set out in this Agreement shall be mutually exclusive and neither Party will take any action to circumvent the other with respect to the matters set out in this Agreement.  The foregoing shall apply to NVS from and after the Effective Date and shall continue for a period of six months following the end of the Term.

 

	
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7.2           BioLine Commitment.  From and after the Effective Date and continuing until the end of the Term, except as otherwise provided in the Agreement, BioLine shall not, directly or indirectly, enter into any discussions or negotiations with a Third Party with a view to out-licensing or otherwise partnering any projects, technology or intellectual property rights sourced from any Israeli sources, or consummate any such transactions in a manner that is not consistent with the terms of this Agreement.

 

7.3           Exclusion of Existing Projects.  For the avoidance of doubt, the arrangements set out in this Agreement specifically do not apply to projects that have been in-licensed by BioLine as of the Effective Date, as set out in Exhibit 7.3 attached hereto.

 

ARTICLE 8

Intellectual Property

 

The Parties acknowledge and agree that, on a Project-by-Project basis and prior to entering into a Sublicense Agreement with respect to a specific Project, as between BioLine and NVS, all data, results, reports, developments, inventions and know-how, and all intellectual property rights therein and thereto, generated or discovered in the course of performing research and development activities in the context of any Project, including in the course of pre-clinical and clinical studies, excluding Pre-existing NVS IP (“Project IP”), shall be the exclusive property of BioLine, unless otherwise agreed in the Core Terms Memorandum.  Subject to the terms of this Agreement, it is further agreed that (i) BioLine may take actions to protect Project IP (including by way of filing and prosecuting patent applications) and exploit Project IP, in its sole discretion, until such time as the Parties enter into a Sublicense Agreement with respect to the Project in question (as which time such matters will be subject to the arrangements agreed in the Sublicense Agreement); and (ii) rights to the Project IP will be licensed to NVS in the context of the Sublicense Agreement, it being clarified that the scope of such rights will be subject to agreement between the Parties in the context of the negotiations for the definitive Sublicense Agreement.

 

ARTICLE 9

Representations And Warranties

 

9.1           Mutual Representations and Warranties.  Each Party hereby represents and warrants to the other Party that, as of the Effective Date:

 

9.1.1           Corporate Existence and Power.  It is a company or corporation duly organized, validly existing, and in good standing (where such concept is recognized) under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement.

 

	
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9.1.2           Authority and Binding Agreement.  It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to and limited by: (i) applicable bankruptcy, insolvency, reorganization, moratorium, and other laws generally applicable to creditors’ rights; and (ii) judicial discretion in the availability of equitable relief.

 

9.1.3           No Conflict.  The execution and delivery of this Agreement, and the performance by such Party of its obligations under this Agreement, including the grant of rights to the other Party pursuant to this Agreement, does not and will not: (i) conflict with, nor result in any violation of or default under any instrument, judgment, order, writ, decree, contract or provision to which such Party is otherwise bound; (ii) give rise to any lien, charge or encumbrance upon any assets of such Party or the suspension, revocation, impairment, forfeiture or non-renewal of any material permit, license, authorization or approval that applies to such Party, its business or operations or any of its assets or properties; or (iii) conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party.

 

9.1.4           Required Consents.  It has obtained, or is not required to obtain, the consent, approval, order, or authorization of any Third Party, or has completed, or is not required to complete, any registration, qualification, designation, declaration or filing with, any Governmental Authority, in connection with the execution and delivery of this Agreement and the performance by such Party of its obligations under this Agreement, including any grant of rights to the other Party pursuant to this Agreement.

 

9.2           Disclaimer.  NVS acknowledges and understands that (i) the projects that are or will be the subject of the Collaboration are at early-stages of development and are or may be the subject of ongoing pre-clinical or clinical research and development, and (ii) BioLine does not and cannot assure that any projects that become subject of the Collaboration, including those included in the Collaboration Quota, will result in products that will be approved by any Regulatory Authority or that will be marketable or commercially successful.

 

9.3           Further Assurances and Indemnification.

 

9.3.1           Each Party will cooperate and do such reasonable acts and things in good faith as may be necessary to effectuate the intents and purposes of this Agreement.

 

9.3.2           BioLine will indemnify and hold NVS and its Affiliates, directors and officers (each, a “NVS Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and costs of investigation that any such NVS Party may suffer or incur as a result of or relating to (a) any breach of any of the representations, warranties, covenants or agreements made by BioLine in this Agreement or (b) any action instituted against the NVS Parties in any capacity, or any of them or their respective Affiliates, by any stockholder of BioLine, with respect to any of the transactions contemplated by this Agreement (unless such action is based upon a breach of NVS’ representations or warranties under this Agreement or any violations by the NVS Parties of state or federal securities laws or any conduct by the NVS Parties which constitutes fraud, gross negligence, or willful misconduct).

 

	
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9.3.3           NVS will indemnify and hold BioLine and its Affiliates, directors and officers (each, a “BioLine Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and costs of investigation that any such BioLine Party may suffer or incur as a result of or relating to (a) any breach of any of the representations, warranties, covenants or agreements made by NVS in this Agreement or (b) any action instituted against the BioLine Parties in any capacity, or any of them or their respective Affiliates, by any stockholder of NVS, with respect to any of the transactions contemplated by this Agreement (unless such action is based upon a breach of BioLine’s representations or warranties under this Agreement or any violations by the BioLine Parties of state or federal securities laws or any conduct by the BioLine Parties which constitutes fraud, gross negligence, or willful misconduct).

 

9.4           No Other Representations or Warranties.  EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 9, SECTION 2.1.3 AND SECTION 2.1.4, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY.

 

ARTICLE 10

Liability

 

To the maximum extent of applicable law, and except for gross negligence, willful misconduct or fraudulent activity, neither Party shall be liable to the other Party for any special, incidental, punitive, indirect, or consequential damages or loss of profits arising from or relating to any breach of this Agreement, regardless of any notice of the possibility of such damages.  Notwithstanding the foregoing, nothing in this section is intended to or shall limit or restrict damages available for a party’s breach of the exclusivity arrangements in Article 7 or the confidentiality obligations in Article 11.

 

ARTICLE 11

Confidentiality

 

11.1         Confidentiality Obligations.  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of seven years thereafter, it shall keep confidential and shall not disclose and shall not use for any purpose other than as expressly provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party.  To avoid doubt, the foregoing non-use restriction shall include, with respect to NVS, the use by NVS or any Affiliate of NVS of any Confidential Information provided by BioLine to contact, discuss or negotiate with any owners or licensors of information and/or intellectual property rights that are included in a Project; provided, however, that such limitation shall terminate upon the in-licensing by BioLine of the subject matter of the Project from the applicable owner or licensor.  The foregoing confidentiality and non-use obligations shall not apply to any portion of the Confidential Information that the receiving Party can demonstrate by competent written proof: (i) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; (ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (iii) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (iv) is subsequently disclosed to the receiving Party by a Third Party who has a legal right to make such disclosure; or (v) is subsequently independently discovered or developed by the receiving Party without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

 

	
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11.2         Authorized Disclosure.  Notwithstanding the obligations set forth in Section 11.1, a Party may disclose the other Party’s Confidential Information, the terms of this Agreement (which terms shall be the Confidential Information of both Parties) and the existence of this Agreement to the extent:

 

11.2.1         such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants or financial advisors (collectively, “Advisors”) for the sole purpose of enabling such Advisors to provide advice to the receiving Party, provided that in each such case on the condition that such Advisors are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; or (ii) to actual or potential investors or acquirers solely for the purpose of evaluating an actual or potential investment or acquisition; provided that in each such case on the condition that such actual or potential investors or acquirers are bound by confidentiality and non-use obligations consistent with those contained in the Agreement;

 

11.2.2         such disclosure is required by securities laws or judicial or administrative process, provided that in such event such Party shall promptly inform the other Party of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations.  Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 11, and the Party disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order, to ensure the continued confidential treatment of such Confidential Information; or

 

11.2.3         such disclosure is reasonably necessary to its actual and potential collaborators (including CROs, CMOs, hospitals, doctors, consultants and subcontractors) for the purpose of the carrying out the Collaboration, on the condition that such entities and/or individuals are bound by confidentiality and non-use obligations consistent with those contained in the Agreement.

 

	
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11.3         Publicity; Use of Names.  Subject to the foregoing and the terms below, no disclosure of the terms of this Agreement may be made by either Party or its Affiliates, and neither Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or other public disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Law.

 

11.3.1         A Party may disclose this Agreement and its terms in securities filings with the SEC or other regulatory agency (or equivalent foreign agency, including the Israel Securities Authority and the Tel Aviv Stock Exchange) to the extent required by Law after complying with the procedure set forth in this Section 11.4.  In such event, the Party seeking such disclosure will prepare a draft confidential treatment request and a proposed redacted version of this Agreement to request confidential treatment for this Agreement, and the other Party agrees to promptly (and in any event, no more than 7 days after receipt of such confidential treatment request and proposed redactions (or such lesser period of time as required by Law)) provide its input in a reasonable manner in order to allow the Party seeking disclosure to file its request within the time lines proscribed by applicable SEC regulations or equivalent foreign agency regulations.  The Party seeking such disclosure shall exercise reasonable commercial efforts to obtain confidential treatment of the Agreement and its terms (as applicable) from the SEC or equivalent foreign agency as represented by the redacted version reviewed by the other Party.

 

11.3.2         Further, each Party acknowledges that the other Party may be legally required to make public disclosures (including in filings with the SEC or other agency) of the execution and delivery of this Agreement as well as certain material developments or material information generated under or pursuant to this Agreement and agrees that each Party may make such disclosures as required by Law, provided that the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure.

 

11.3.3         During the Term, each Party shall have the right to issue a press release or make a public announcement concerning the material terms of this Agreement or the development of a project undertaken as part of the Collaboration.  If a Party desires to issue such a press release or make such a public announcement, it shall provide the other Party with reasonable advance notice of the content thereof.  The other Party shall have the right to review and comment on such proposed press release or announcement and the Party proposing such press release or public announcement shall take into consideration and incorporate when appropriate the comment from the other Party; provided, however, that in the event that a Party does not respond within 3 business days of the date on which the announcement was provided to such Party, the Party desiring to issue the release or make the announcement may proceed to do so.

 

11.3.4         The Parties agree that after a public disclosure pursuant to Sections 11.4.1, 11.4.2 or 11.4.3 has been reviewed and approved by the other Party (or be deemed to have been approved), the disclosing Party may make subsequent public disclosures or issue a press release disclosing the same content as was contained in such public disclosure without having to obtain the other Party’s prior consent and approval.

 

	
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11.4         Equitable Relief. Each Party acknowledges that a breach of this Article 11 may not reasonably or adequately be compensated in damages in an action at law and that such a breach shall cause the other Party irreparable injury and damage.  By reason thereof, each Party agrees that the other Party may be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to seek preliminary and permanent injunctive and other equitable relief from any court of competent jurisdiction to prevent or curtail any breach of the obligations relating to Confidential Information set forth herein by the other Party.

 

ARTICLE 12

Term and Termination

 

12.1         Term.  The term (“Term”) of this Agreement shall commence on the Effective Date and, unless earlier terminated pursuant to this Article 12, will continue in effect until the first to occur of (i) payment by NVS of the Option Fee in respect of three Projects or (ii) the later of (A) three years from the Effective Date or (B) the presentation by BioLine to NVS at the Joint Steering Committee of [*]

 

12.2         Termination for Breach.

 

12.2.1         Notice.  If either Party believes that the other Party is in material breach of this Agreement, then the Party holding such belief (the “Non-Breaching Party”) may deliver written notice of such breach to the other Party (the “Notified Party”).  The Notified Party shall have 30 days after receipt of such notice to cure such breach.

 

12.2.2         Failure to Cure.  If the Notified Party fails to cure a material breach of this Agreement as provided for in Section 12.2.1, then the Non-Breaching Party may terminate this Agreement immediately upon written notice to the Notified Party.

 

12.2.3         Disputes.  If a Party gives notice of termination under this Section 12.2 and the other Party disputes whether such termination is proper under this Section 12.2, then the issue of whether this Agreement may properly be terminated (i.e., whether a material breach occurred or whether a material breach was cured) shall be resolved in accordance with Article 13.  If as a result of such dispute resolution process it is determined that the notice of termination was proper, then such termination shall be deemed to have been effective 30 days following the date of the notice of breach.  If, as a result of such dispute resolution process, it is determined that the notice of termination was improper, then no termination shall have occurred and this Agreement shall remain in effect.

 

12.3         Effect of Termination of the Agreement.  Expiration or termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such expiration or termination or to which a Party may be contractually committed as of such effective date nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any material breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation.

 

12.4         Survival.  The following provisions shall survive any expiration or termination of this Agreement for the period of time specified: the provisions of Article 1, to the extent definitions are embodied in the following listed Articles and Sections of this Agreement; Articles 7, 8, 10, 11, 13 and 14; and Sections 6.9.5, and this Section 12.4, to the extent applicable.  In addition, those provisions of Articles 3, 4, 5 and 6 that are applicable to the selection, decision-making, oversight, development and budgeting process regarding Projects that, as of the date of expiration or termination, remain part of the Collaboration pursuant to the arrangements set out in the Agreement, as well as Sections 2.2 (Stand-Still Agreement) and 2.3 (Trading Restrictions), will survive any expiration or termination of this Agreement until such time as the last of such Projects is either in-licensed by NVS pursuant to a Sublicense Agreement or until such time as the JSC decides not to proceed with the further development and funding of such Project (or fails to make a decision with respect thereto within the designated time period).   Other provisions either required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement, or which by their express terms, survive such expiration or termination of this Agreement.

 

	
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ARTICLE 13

Dispute Resolution

 

13.1         Disputes.  The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights or obligations hereunder.  It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 13 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

 

13.2         Internal Resolution.  With respect to all disputes arising between the Parties under this Agreement, including any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within 30 days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Executives of the Parties for attempted resolution by good faith negotiations within 30 days after such notice is received.

 

13.3         Binding Arbitration.  If the Executives are not able to resolve such disputed matter within 30 days and either of the Parties wishes to pursue the matter, each such dispute, controversy or claim shall be referred to and finally determined by arbitration by the International Chamber of Commerce in accordance with its arbitration rules then in effect.  The place of arbitration shall be New York, New York.  The language to be used in the arbitral proceedings shall be English.  The dispute, controversy or claim shall be decided in accordance with the law of the State of New York, and U.S. federal law applicable therein.  Judgment on the arbitration award may be entered in any court having jurisdiction thereof.  The Parties agree that:

 

13.3.1         Either Party may apply to the arbitrator(s) for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved.  Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award.  The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damage.  Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration regardless of the outcome of such arbitration.

 

	
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13.3.2         A Party shall be entitled to deduct or otherwise offset any damage finally awarded under a proceeding initiated under Section 13.3 against payments due under this Agreement, subject to any other decision of the arbitrators.

 

13.3.3         Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of arbitration without the prior written consent of both Parties.  In no event shall arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations under the laws of the State of New York.

 

13.3.4         Notwithstanding the foregoing, neither Party shall be prevented from seeking injunctive relief from a court of competent jurisdiction including but not limited to the situation contemplated in Section 11.5 (to prevent or curtail any breach of the obligations relating to Confidential Information as set forth in Article 11).

 

ARTICLE 14

Miscellaneous

 

14.1         Entire Agreement; Amendment.  This Agreement, including the Exhibits hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein.  No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

 

14.2         Payments and Taxes.  All payments made pursuant to this Agreement shall be made by wire transfer to an account designated by BioLine in writing to NVS and shall be made in Dollars.  The Parties shall use all reasonable and legal efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by NVS to BioLine under this Agreement.

 

14.3         Force Majeure.  Each Party shall be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition.  For purposes of this Agreement, force majeure shall include conditions beyond the reasonable control of the nonperforming Party, including an act of God or terrorism, involuntary compliance with any regulation, law or order of any government, war, civil commotion, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe.  Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party.  If a force majeure persists for more than 90 days, then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

 

	
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14.4         Notices.  Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this section, and shall be deemed to have been sufficiently given for all purposes when received, if in writing and personally delivered, one day following facsimile or email transmission (receipt verified) or 2 days following overnight express courier service (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below.

 

 

	 If to BioLine	 	BioLineRx Ltd.	 	 
	 	 	19 Hartum Street	 	 
	 	 	PO Box 45158	 	 
	 	 	Jerusalem, 91450	 	 
	 	 	Israel	 	 
	 	 	Attention:        	Chief Executive Officer	 
	 	 	With a copy to:      	Chief Operating Officer	 
	 	 	Fax: +972-2-548-9101	 	 
	 	 	Email: 	kinnerets@biolinerx.com	 
	 	 	 	phils@biolinerx.com	 
	 	 	 	 	 
	With copies to (which shall not constitute notice):	 
	 	 	 	 	 
	 	 	Yigal Arnon & Co., Law Offices	 	 
	 	 	22 Rivlin Street	 	 
	 	 	Jerusalem, 9424018	 	 
	 	 	Israel	 	 
	 	 	Attention:   	Barry Levenfeld, Adv.	 
	 	 	 	Daniel Green, Adv.	 
	 	 	 	+972-2-623-9236	 
	 	 	 	barry@arnon.co.il	 
	 	 	 	danielg@arnon.co.il	 
	 	 	 	 	 
	If to NVS: 	 	Novartis Pharma AG	 	 
	 	 	P.O. Box	 	 
	 	 	CH - 4002 Basel	 	 
	 	 	Switzerland	 	 
	 	 	Attention:       	Head, Business Development and Licensing	 
	 	 	Fax:  	+41-61-324-2511	 
	 	 	Email:  	Corinne.savill@novartis.com	 
	 	 	 	 	 
	 With copies to (which shall not constitute notice):	 
	 	 	 	 	 
	 	 	Novartis Pharma AG	 	 
	 	 	P.O. Box	 	 
	 	 	CH - 4002 Basel	 	 
	 	 	Switzerland	 	 
	 	 	Attention:	Head, Legal Department	 
	 	 	Fax: 	+41-61-324-7399	 
	 	 	Email:  	sean.reilly@novartis.com	 
	 	 	 	 	 

	
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14.5         No Strict Construction; Headings.  This Agreement has been prepared jointly and shall not be strictly construed against either Party.  Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.  The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.

 

14.6         Assignment.  Neither party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other; provided, however, that either Party may assign or transfer this Agreement or any rights or obligations hereunder to an Affiliate of such Party and, in such event, shall provide written notice thereof to the other Party.  Any permitted assignee or transferee of rights or obligations hereunder shall expressly assume in writing the performance of such rights or obligations.  Any permitted assignment or transfer shall be binding on the successors of the assigning or transferring party.  Any assignment or attempted assignment in violation of the terms of this section shall be void and of no legal effect.

 

14.7         Performance by Affiliates.  Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates, and when any such Affiliate is discharging such obligations or exercising such right, the terms and conditions of this Agreement applicable to such Party also shall be applicable to such Affiliate; provided, however, that prior to NVS engaging any of its Affiliates to so discharge NVS’s obligations and/or exercise any of NVS’s rights as aforesaid, NVS shall obtain BioLine’s prior written consent to such engagement.  Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations and/or exercise of such Party’s rights under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.  Any breach by a Party’s Affiliate of any of such Party’s obligations and/or exercise of such Party’s rights under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

 

14.8         Further Cooperation by the Parties.  The Parties shall cooperate in good faith to effectively and efficiently implement the objectives of this Agreement.

 

14.9         Severability.  If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof.  The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

 

	
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14.10       No Waiver.  Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

 

14.11       Independent Contractors.  Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way.  Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

 

14.12       Expenses.  All fees, costs and expenses of either Party incurred in connection with this Agreement and the transactions contemplated hereby, including fees and expenses of financial advisors, financial sponsors, legal counsel and other advisors, shall be paid by the Party incurring such expenses.

 

14.13       No Third Party Beneficiaries.  Except for rights and obligations specifically referred to herein that apply to Affiliates, sublicenses or licensees of the Parties, nothing in this Agreement is intended to confer on any Person other than BioLine or NVS any rights or obligations under this Agreement, and there are no intended Third Party beneficiaries to this Agreement.

 

14.14       English Language.  This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.  To the extent this Agreement requires a Party to provide to the other Party Information, correspondence, notice or other documentation, such Party shall provide such Information, correspondence, notice or other documentation in the English language.

 

14.15       Governing Law.  This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the laws of the State of New York, and US federal law applicable therein, without giving effect to any choice of law principles that would require the application of the laws of a different state.  The applicability of the United Nations Convention on Contracts for the International Sale of Goods of 1980 is hereby expressly excluded.

 

	
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14.16       Construction.  Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “include,” “includes” and “including” are not limiting and shall be deemed to be followed by “without limitation”; (b) definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms; (c) references to an agreement, statute or instrument mean such agreement, statute or instrument as from time to time amended, modified or supplemented; (d) references to a Person are also to its permitted successors and assigns; (e) the plain meaning of the description for a defined term, and other headings to this Agreement are for convenience only, and shall have no force or effect in construing or interpreting any of the provisions of this Agreement or any other legal effect; (f) references to “Parties”, “Article”, “Section”, “Exhibit” or “Schedule” refer to the Parties to, an Article or Section of, or any Exhibit or Schedule to, this Agreement, unless otherwise indicated; (g) the word “will” shall be construed to have the same meaning and effect as the word “shall” and vice versa; and (h) the word “or” has, except where otherwise indicated or where the context otherwise requires, the inclusive meaning represented by the phrase “and/or”.

 

14.17       Counterparts.  This Agreement may be executed in one or more counterparts by original or facsimile signature, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of page left intentionally blank.  Signature page follows immediately.]

 

	
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[Signature page to Investment and Collaboration Agreement]

 

In Witness Whereof, the Parties have executed this Investment and Collaboration Agreement in duplicate originals by their duly authorized officers as of the Execution Date.

 

	Novartis Pharma AG	 	 	BioLineRx, Ltd.
	 	 	 	 	 	 	 
	By:   	/s/ Marc Ceulemans	 	 	By:   	/s/ Kinneret Livnat Savitsky    	 
	Name: 	March Ceulemans	 	 	Name:	Kinneret Livnat Savitsky	 
	Title: 	Head Strategic Venture	 	 	Title:	CEO	 
	 	Capital Fund and Pharma Equities	 	 	 	 	 
	 	 	 	 	 	 	 
	By:   	/s/ Matt Owens        	 	 	By:   	/s/ Philip Serlin  	 
	Name:	Matt Owens	 	 	Name:	Philip Serlin	 
	Title: 	Head Legal GBS & Strategy	 	 	Title: 	Chief Financial and Operating Officer	 

 

	
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Exhibit 2.1

ADS Price Adjustment Schedule

	
BIOLINERX LTD.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
CALCULATION OF SHARE PRICE TO NVS

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
DEC-2014

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Total investment amount

	 	$	10,000,000	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Maximum premium

	 	$	3,000,000	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Actual value of ADSs

	 	$	7,000,000	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Number of ADSs of BioLineRx outstanding pre-transaction

	 	 	34,115,051	 	 	 	 	 	 	 	 	 	 	 	 	 
	  	 	
Closing Price per ADS

	 	 	
Number of ADSs to Issue to Novartis

	 	 	
Price per ADS to NVS

	 	 	
% holdings of Novartis after investment

	 	 	
Test of aggregate premium

	 
	  	 	$	0.80	 	 	 	8,750,000	 	 	$	1.14	 	 	 	20.4	%	 	$	3,000,000	 
	  	 	$	0.81	 	 	 	8,641,975	 	 	$	1.16	 	 	 	20.2	%	 	$	3,000,000	 
	  	 	$	0.82	 	 	 	8,536,585	 	 	$	1.17	 	 	 	20.0	%	 	$	3,000,000	 
	  	 	$	0.83	 	 	 	8,433,735	 	 	$	1.19	 	 	 	19.8	%	 	$	3,000,000	 
	  	 	$	0.84	 	 	 	8,333,333	 	 	$	1.20	 	 	 	19.6	%	 	$	3,000,000	 
	  	 	$	0.85	 	 	 	8,235,294	 	 	$	1.21	 	 	 	19.4	%	 	$	3,000,000	 
	  	 	$	0.86	 	 	 	8,139,535	 	 	$	1.23	 	 	 	19.3	%	 	$	3,000,000	 
	  	 	$	0.87	 	 	 	8,045,977	 	 	$	1.24	 	 	 	19.1	%	 	$	3,000,000	 
	  	 	$	0.88	 	 	 	7,954,545	 	 	$	1.26	 	 	 	18.9	%	 	$	3,000,000	 
	  	 	$	0.89	 	 	 	7,865,169	 	 	$	1.27	 	 	 	18.7	%	 	$	3,000,000	 
	  	 	$	0.90	 	 	 	7,777,778	 	 	$	1.29	 	 	 	18.6	%	 	$	3,000,000	 
	  	 	$	0.91	 	 	 	7,692,308	 	 	$	1.30	 	 	 	18.4	%	 	$	3,000,000	 
	  	 	$	0.92	 	 	 	7,608,696	 	 	$	1.31	 	 	 	18.2	%	 	$	3,000,000	 
	  	 	$	0.93	 	 	 	7,526,882	 	 	$	1.33	 	 	 	18.1	%	 	$	3,000,000	 
	  	 	$	0.94	 	 	 	7,446,809	 	 	$	1.34	 	 	 	17.9	%	 	$	3,000,000	 
	  	 	$	0.95	 	 	 	7,368,421	 	 	$	1.36	 	 	 	17.8	%	 	$	3,000,000	 
	  	 	$	0.96	 	 	 	7,291,667	 	 	$	1.37	 	 	 	17.6	%	 	$	3,000,000	 
	  	 	$	0.97	 	 	 	7,216,495	 	 	$	1.39	 	 	 	17.5	%	 	$	3,000,000	 
	  	 	$	0.98	 	 	 	7,142,857	 	 	$	1.40	 	 	 	17.3	%	 	$	3,000,000	 
	  	 	$	0.99	 	 	 	7,070,707	 	 	$	1.41	 	 	 	17.2	%	 	$	3,000,000	 
	  	 	$	1.00	 	 	 	7,000,000	 	 	$	1.43	 	 	 	17.0	%	 	$	3,000,000	 
	  	 	$	1.01	 	 	 	6,930,693	 	 	$	1.44	 	 	 	16.9	%	 	$	3,000,000	 
	  	 	$	1.02	 	 	 	6,862,745	 	 	$	1.46	 	 	 	16.7	%	 	$	3,000,000	 
	  	 	$	1.03	 	 	 	6,796,117	 	 	$	1.47	 	 	 	16.6	%	 	$	3,000,000	 
	  	 	$	1.04	 	 	 	6,730,769	 	 	$	1.49	 	 	 	16.5	%	 	$	3,000,000	 
	  	 	$	1.05	 	 	 	6,666,667	 	 	$	1.50	 	 	 	16.3	%	 	$	3,000,000	 
	  	 	$	1.06	 	 	 	6,603,774	 	 	$	1.51	 	 	 	16.2	%	 	$	3,000,000	 
	  	 	$	1.07	 	 	 	6,542,056	 	 	$	1.53	 	 	 	16.1	%	 	$	3,000,000	 
	  	 	$	1.08	 	 	 	6,481,481	 	 	$	1.54	 	 	 	16.0	%	 	$	3,000,000	 
	  	 	$	1.09	 	 	 	6,422,018	 	 	$	1.56	 	 	 	15.8	%	 	$	3,000,000	 
	  	 	$	1.10	 	 	 	6,363,636	 	 	$	1.57	 	 	 	15.7	%	 	$	3,000,000	 

 

	
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	  	 	$	1.11	 	 	 	6,306,306	 	 	$	1.59	 	 	 	15.6	%	 	$	3,000,000	 
	  	 	$	1.12	 	 	 	6,250,000	 	 	$	1.60	 	 	 	15.5	%	 	$	3,000,000	 
	  	 	$	1.13	 	 	 	6,194,690	 	 	$	1.61	 	 	 	15.4	%	 	$	3,000,000	 
	  	 	$	1.14	 	 	 	6,140,351	 	 	$	1.63	 	 	 	15.3	%	 	$	3,000,000	 
	  	 	$	1.15	 	 	 	6,086,957	 	 	$	1.64	 	 	 	15.1	%	 	$	3,000,000	 
	  	 	$	1.16	 	 	 	6,034,483	 	 	$	1.66	 	 	 	15.0	%	 	$	3,000,000	 
	  	 	$	1.17	 	 	 	5,982,906	 	 	$	1.67	 	 	 	14.9	%	 	$	3,000,000	 
	  	 	$	1.18	 	 	 	5,932,203	 	 	$	1.69	 	 	 	14.8	%	 	$	3,000,000	 
	  	 	$	1.19	 	 	 	5,882,353	 	 	$	1.70	 	 	 	14.7	%	 	$	3,000,000	 
	  	 	$	1.20	 	 	 	5,833,333	 	 	$	1.71	 	 	 	14.6	%	 	$	3,000,000	 
	  	 	$	1.21	 	 	 	5,785,124	 	 	$	1.73	 	 	 	14.5	%	 	$	3,000,000	 
	  	 	$	1.22	 	 	 	5,737,705	 	 	$	1.74	 	 	 	14.4	%	 	$	3,000,000	 
	  	 	$	1.23	 	 	 	5,691,057	 	 	$	1.76	 	 	 	14.3	%	 	$	3,000,000	 
	  	 	$	1.24	 	 	 	5,645,161	 	 	$	1.77	 	 	 	14.2	%	 	$	3,000,000	 
	  	 	$	1.25	 	 	 	5,600,000	 	 	$	1.79	 	 	 	14.1	%	 	$	3,000,000	 
	  	 	$	1.26	 	 	 	5,555,556	 	 	$	1.80	 	 	 	14.0	%	 	$	3,000,000	 
	  	 	$	1.27	 	 	 	5,511,811	 	 	$	1.81	 	 	 	13.9	%	 	$	3,000,000	 
	  	 	$	1.28	 	 	 	5,468,750	 	 	$	1.83	 	 	 	13.8	%	 	$	3,000,000	 
	  	 	$	1.29	 	 	 	5,426,357	 	 	$	1.84	 	 	 	13.7	%	 	$	3,000,000	 
	  	 	$	1.30	 	 	 	5,384,615	 	 	$	1.86	 	 	 	13.6	%	 	$	3,000,000	 
	  	 	$	1.31	 	 	 	5,343,511	 	 	$	1.87	 	 	 	13.5	%	 	$	3,000,000	 
	  	 	$	1.32	 	 	 	5,303,030	 	 	$	1.89	 	 	 	13.5	%	 	$	3,000,000	 
	  	 	$	1.33	 	 	 	5,263,158	 	 	$	1.90	 	 	 	13.4	%	 	$	3,000,000	 
	  	 	$	1.34	 	 	 	5,223,881	 	 	$	1.91	 	 	 	13.3	%	 	$	3,000,000	 
	  	 	$	1.35	 	 	 	5,185,185	 	 	$	1.93	 	 	 	13.2	%	 	$	3,000,000	 
	  	 	$	1.36	 	 	 	5,147,059	 	 	$	1.94	 	 	 	13.1	%	 	$	3,000,000	 
	  	 	$	1.37	 	 	 	5,109,489	 	 	$	1.96	 	 	 	13.0	%	 	$	3,000,000	 
	  	 	$	1.38	 	 	 	5,072,464	 	 	$	1.97	 	 	 	12.9	%	 	$	3,000,000	 
	  	 	$	1.39	 	 	 	5,035,971	 	 	$	1.99	 	 	 	12.9	%	 	$	3,000,000	 
	  	 	$	1.40	 	 	 	5,000,000	 	 	$	2.00	 	 	 	12.8	%	 	$	3,000,000	 

 

	
BioLineRx - Novartis Pharma AG Collaboration Agreement

  

31

  

 

Exhibit 4.1

[*]

	
BioLineRx - Novartis Pharma AG Collaboration Agreement

  

32

  

 

Exhibit 6.4

Form of Invoice

	
Sender’s Logo

	  	
      INVOICE

	  	  	
INVOICE DATE:

	
Street

	  	
__ ________ 201_

	
Town, Country

	  	  
	
Phone and Fax Nr.

	  	
INVOICE No.: XXXX

	  	  	  
	
Bill To:

	
For:

	  
	
Novartis Pharma AG

	
[X]

	Lichtstrasse 35	 
	CH-4056	 
	Basel, Switzerland	 
	  	  	  
	
DESCRIPTION [Please specify the event for which the invoice is due]

	
AMOUNT (USD)

	  	
US$ 000'000.00

	  	  
	
Novartis Contract Code

	  	  
	  	  	  
	
Please remit by wire transfer within 60 days to:

	  
	
       Receiving Bank -

	  	  
	
       Swift Code -

	  	  
	
       ABA Number -

	  	  
	
       Credit Account -

	  	  
	
       Beneficiary - 

	  	  
	  	  	  
	  	
TOTAL

	
 000'000,00

	  	  	  
	
If you have any questions concerning this invoice, contact 

	  
	
or e-mail to 

	  	  
	
VAT -Reg. No. Xxxxxxxxxx (if applicable)

	  	  

 

	
BioLineRx - Novartis Pharma AG Collaboration Agreement

  

33

  

 

Exhibit 7.3

Excluded Projects

 

BL-8040

BL-7010

BL-1040

BL-5010

BL-7040

BL-9010

BL-9020

BL-8020

BL-8030

BL-1110

 

	
BioLineRx - Novartis Pharma AG Collaboration Agreement

34exhibit_4-39.htm

Exhibit 4.39

[*] Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.

 

LICENSE AGREEMENT

 

This license agreement (“Agreement”) is entered into as of December 22nd, 2014 (“Effective Date”) by and between BioLineRx Ltd., having its principal place of business at 19 Hartum Street, Jerusalem 9777518, Israel (“Licensor”), and [*], on behalf of itself and its Affiliates, having its principal place of business at [*] (all such entities to be referred to collectively as “Licensee”).  Licensor and Licensee may be referred to herein individually as a “Party” and collectively as the “Parties.”

 

Recitals

 

Licensor Controls rights in certain intellectual property which is the subject of this Agreement;

Licensee desires to obtain a license from Licensor related to such intellectual property Controlled by Licensor, as set forth in this Agreement; and

Licensor is willing to grant such a license under the terms and conditions of this Agreement;

NOW, THEREFORE, in consideration of the mutual covenants herein contained, the Parties agree as follows:

1.            Definitions

	
1.1

	
“Affiliate” means, with respect to a Party, any person, corporation, partnership or other entity that directly or indirectly controls, is controlled by, or is under common control with such Party.  As used in this definition, the term “control” (and, with correlative meaning, the terms “controlled by” and “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of more than fifty percent (50%) of the voting stock of such entity (or such lesser maximum ownership interest percentage permitted by applicable law and considered a control percentage in a particular jurisdiction), or by contract or otherwise.

	
1.2

	
“Change of Control” means, in respect of a Party, the consummation of a single transaction, or of a transaction that is part of a series of transactions, (a) in which a Third Party acquires, merges or consolidates with such Party, or possesses (directly or indirectly) the power to direct or cause the direction of management or policies of such Party through ownership of a majority of securities, partnership, or other ownership rights or agreements; or (b) in which such Party transfers or sells all or substantially all of its assets or business to which this Agreement relates; provided, however, that a transaction in which the stockholders of such Party immediately prior to the transaction own, directly or indirectly, fifty percent (50%) or more of the voting power of the surviving corporation following the transaction shall not be considered a Change of Control.

 

  

  

  

 

	
1.3

	
“Confidential Information” means any and all inventions, ideas, discoveries, data, instructions, designs, information, components, methods, tools, developments, innovations, techniques, materials, technology, protocols, procedures, results, formulae, trade secrets, know-how and other non-public and proprietary materials, products, processes or information, including research, product plans, manufacturing processes, manufacturing or operating costs, services, software, hardware, customer lists, price lists, business plans, marketing plans or financial information, that is or was disclosed or supplied by a Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) after the Effective Date in connection with this Agreement.

 

Notwithstanding the foregoing, Confidential Information shall not include any part of the foregoing that the Receiving Party can demonstrate through competent, contemporaneous written records:

 

	
  

	
a.

	
was already known to the Receiving Party, other than any portion of such information that was under an obligation of confidentiality at the time of its disclosure;

 

	
  

	
b.

	
Became generally available to the public or otherwise becomes part of the public domain after disclosure of such information to the Receiving Party, other than by breach of this Agreement by the Receiving Party or by anyone to whom the Receiving Party disclosed such information;

 

	
  

	
c.

	
was subsequently lawfully, and without any restriction on disclosure, disclosed to the Receiving Party by a Third Party; or

 

	
  

	
d.

	
was independently developed or discovered by employees of the Receiving Party who had no access to the Confidential Information of the Disclosing Party and did not make use of the Confidential Information of the Disclosing Party, as demonstrated by competent, contemporaneous written records.

	
  

	 

	
1.4

	
“Control” or “Controlled by” means, in the context of a license to or ownership of intellectual property, the ability on the part of a Party to grant access to or a license or sublicense of such intellectual property as provided for herein without violating the terms of any agreement or other arrangement between such Party and any Third Party existing at the time such Party would be required hereunder to grant such access or license or sublicense.

	
1.5

	
“Field of Use” means all over-the-counter (“OTC”) therapeutic applications in any diseases in humans and animals.

 

  

2

  

 

	
1.6

	
“First Sale” means the first commercial sale of a Licensed Product unit by Licensee or one of its Sublicensees.

	
1.6

	
“Inventions” means all inventions, discoveries and developments conceived, first reduced to practice or otherwise discovered or developed by Licensee or its Sublicensees, or any of their respective personnel, in the course of use, practice and/or exploitation of the license rights granted to Licensee under this Agreement.

	
1.7

	
“Licensed Patents” means the issued patents (“Issued Patents”) and pending patent applications (“Pending Patent Applications”) in the Territory (a) Controlled by Licensor; (b) that are filed prior to the Effective Date; and (c) that are necessary or useful for Licensee’s research, development, manufacturing, or commercialization activities relating to Licensed Products in the Field of Use.  The Licensed Patents existing in the Territory as of the Effective Date are set forth in Schedule A, attached hereto and incorporated herein by reference.  The term “Licensed Patents” will include any and all related domestic and foreign counterparts, divisions, continuations, continuations-in-part, reissues, reexaminations, substitutes and extensions thereof in the Territory that are Controlled by Licensor and rely on the priority date of an Issued Patent or a Pending Patent Application.

	
1.8

	
“Licensed Product” means a BL-5010 applicator or formulation or their combination (a) wherein the use or practice of such product would, but for the license granted herein, infringe a Valid Claim within the Licensed Patents, or (b) that uses, comprises, contains or incorporates Licensed Technology.

	
1.9

	
“Licensed Technology” means data, results, technology, and information of any type whatsoever, in any tangible or intangible form, that is disclosed by Licensor and is necessary or useful for research, development, regulatory or clinical activities, manufacture, commercialization or other use or exploitation of Licensed Product in the Field of Use in accordance with the terms of this Agreement, including (but not limited to) know-how, trade secrets, practices, techniques, methods, devices, instruments, designs, systems, materials, strategies and expertise, test data and other technical data.  The term “Licensed Technology” expressly excludes Licensed Patents.

	
1.10

	
“New IP” means any and all new intellectual property rights (a) arising in the course of use, practice and/or exploitation of the license rights granted to Licensee under this Agreement (including but not limited to information, know-how, data, designs, methods, processes, techniques, materials, formulae, trade secrets, trademarks, copyrights, patents and patent applications and other proprietary information), (b) identified, developed, generated or obtained by Licensee or its Sublicensees, and (c) related to Licensed Patents, Licensed Technology or Licensed Products. For the avoidance of doubt, it is hereby clarified that “New IP” does not include Trademarks as defined in Section 1.14 and that the Trademarks and trade dress of Licensee, related copyrightable material, domain names, used on and/or in connection with any of the Licensed Products whether used on Products, packaging, labeling, advertising, sales promotion materials, or otherwise are and shall remain the ownership of Licensee.

 

  

3

  

 

	
1.11

	
“Sublicense” means any right granted, license given, or agreement entered into, by Licensee to or with any other person or entity, under or with respect to or permitting any use or exploitation of any Licensed Patent or any of the Licensed Technology (or any part thereof) or otherwise permitting the development, manufacture, marketing, distribution and/or sale of Licensed Products.

	
1.12

	
“Sublicensee” means a person or entity granted a Sublicense in accordance with Section 2.2. For the avoidance of doubt, an Affiliate of Licensee is not considered to be a Sublicensee.

	
1.13

	
“Territory” means the countries listed in Schedule B, attached hereto and incorporated herein by reference.

	
1.14

	
“Trademark” means any trademark or brand created by Licensee and used in connection with the Licensed Product.

	
1.15

	
“Third Party” shall mean any person or entity other than the Parties or their Affiliates.

	
1.16

	
“Upstream License Agreement” shall mean that certain License Agreement dated November 25, 2007 between the Upstream Licensor and BioLine, including its amendments/addendums thereto (if any), as it may be amended from time to time.

	
1.17

	
“Upstream Licensor” shall mean Innovative Pharmaceutical Concepts (IPC) Inc., having a place of business at Geneva Place, 2nd Floor, Waterfront Drive, PO Box 3339, Road Town, Tortola, British Virgin Islands.

	
1.18

	
“Valid Claim” means (a) a claim of an Issued Patent that is not expired, which has not been held unpatentable, invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been disclaimed or admitted to be invalid or unenforceable through reissue, re-examination or otherwise, or (b) a claim of a Pending Patent Application that has not been abandoned, finally rejected, or expired.

	
2.

	
Grant

	
2.1

	
During the Term, and subject to the terms of this Agreement, Licensor hereby grants to Licensee an exclusive license, with the right to Sublicense (subject to the conditions in Section 2.2), under the Licensed Patents and Licensed Technology to make, use, sell, offer to sell, import and otherwise exploit Licensed Products within the Field of Use in the Territory.

	
2.2

	
Sublicenses.

 

	
  

	
a.

	
Subject to the terms and conditions of this Section 2.2, Licensee shall be entitled to grant Sublicenses to third parties under the license granted to Licensee pursuant to Section 2.1.  All such Sublicenses shall be made for consideration and in arm’s length transactions.

  

4

 

	
  

	
b.

	
Sublicenses to Sublicensees shall only be granted pursuant to written agreements.  Licensee shall provide Licensor with a copy of each Sublicense agreement within twenty (20) days of receipt of an executed agreement from the Sublicensee.  Each such Sublicense agreement shall contain, inter alia, provisions to the following effect:

 

(i)           All provisions necessary to ensure Licensee’s compliance with its obligations under this Agreement, including reporting and audit requirements;

 

(ii)           In the event of termination of the license granted to Licensee under this Agreement and if no new agreement is entered into between Licensee and the Upstream Licensor, any existing Sublicense agreements that contain a Sublicense of Licensed Patents or Licensed Technology shall terminate to the extent of such Sublicense; and

 

(iii)           Licensee must obtain Licensor’s prior written approval for any proposed further sublicensing by the Sublicensee of the Sublicense granted to such Sublicensee (not to be unreasonably withheld).  If Licensor approves any such further Sublicense grant, the corresponding Sublicense agreement shall be subject to execution of a written agreement consistent with the terms of this Section 2.2, and shall be made for consideration and in arm’s length transactions.  For clarity, if a Sublicensee has been granted commercialization rights in a Core Country (as defined in subsection (c) below) with Licensor’s approval, such Sublicensee may not further sublicense any of those commercialization rights in a Core Country without Licensor’s prior written approval.

 

	
  

	
c.

	
The Parties will mutually agree upon countries within the Territory where Licensee is required to commercialize Licensed Products itself or through its Affiliates (and only through a Sublicensee with the prior written approval of Licensor).  Such countries are or will be listed in Schedule C, attached hereto and incorporated herein by reference (each a “Core Country”), which schedule may be amended from time to time by written mutual agreement of the Parties.  For the grant of a Sublicense by Licensee that does not involve the right to commercialize Licensed Product(s) in a Core Country, or that involves a Sublicense grant in a country in the Territory that is not a Core Country, Licensee is not required to obtain Licensor’s prior written approval for Licensee’s grant of  this type of Sublicense; however, in each case of a granted Sublicense to a Sublicensee (including a Sublicense granted by a Sublicensee), Licensee must provide to Licensor a copy of any such executed Sublicense agreement within twenty (20) days after execution; provided that, if the granted Sublicense is a portion of a broader license or sublicense agreement, Licensee may redact the portions of the broader agreement that do not pertain to a Sublicense under this Agreement.  Licensee may not redact the effective date of the Sublicense agreement or the name and address of the Sublicensee.

 

	
  

	
d.

	
Any permitted Sublicense granted by Licensee (or granted by a Sublicensee in accordance with this Section 2.2) will:

 

(i)           incorporate terms and conditions into the corresponding Sublicense agreement sufficient to enable Licensee and each Sublicensee to comply with this Agreement;

 

  

5

  

 

(ii)           be consistent with the terms, conditions and limitations of this Agreement that are applicable to such Sublicensee (including, without limitation, diligence obligations with respect to Licensed Products),

 

(iii)           contain a prohibition against Sublicensee commercializing [*] that could be competitive with Licensed Products; and

 

(iv)           terminate on termination of this Agreement.

 

	
2.3

	
Notwithstanding anything to the contrary in this Agreement, if a Sublicense granted by Licensee is terminated due to termination of this Agreement and a Sublicensee of Licensee is in compliance in all material respects with the terms of its Sublicense from Licensee in effect on the date of termination of this Agreement, Licensor will negotiate in good faith a grant directly to the Sublicensee of a substantially similar Sublicense under the Licensed Patents and Licensed Technology as compared to the Sublicense agreement executed by Licensee and such Sublicensee.

	
2.4

	
Licensor reserves all rights not expressly licensed or granted to Licensee hereunder, and nothing in this Agreement entitles Licensee to use any intellectual property of Licensor other than the Licensed Patents and Licensed Technology to exploit Licensed Products (for clarity, Licensed Products include filled BL-5010 applicators; BL-5010 formulations alone (without BL-5010 applicators); and the combination of BL-5010 applicators and BL-5010 formulations, (but expressly exclude unfilled BL-5010 applicators) in the Field of Use in the Territory.  Without Licensor’s written approval, Licensee is not permitted to use or reference the name or trade names of Licensor in connection with Licensee’s promotion, practice or use of the Licensed Products, Licensed Patents or Licensed Technology.

	
2.5

	
During the first two months following the Effective Date, Licensor shall transfer to Licensee the information comprising Licensed Technology at no charge to Licensee. Thereafter, Licensor will provide technical support to Licensee in connection with the Licensed Patents and/or Licensed Technology, including but not limited to assistance in clinical development and regulatory matters, under terms and conditions to be separately negotiated by the Parties in writing.

	
2.6

	
A copy of the Upstream License Agreement (with financial terms redacted) has been provided to Licensee prior to the Effective Date.  In the event that the Upstream License Agreement is terminated, then pursuant to Section 2.2.2.2 of the Upstream License Agreement, Licensee (as a sublicensee of the Upstream Licensor) has the right to request from the Upstream Licensor a new license agreement between Licensee and the Upstream Licensor. In such case, Licensor shall, at Licensee’s request, provide all reasonable assistance to Licensee in Licensee’s efforts to enter into a license agreement with the Upstream Licensor on substantially the same terms as those contained in this Agreement, including through enforcement of the provisions of Section 2.2.2.2 of the Upstream License Agreement.

  

6

  

	
2A.

	
Joint Steering Committee

	
2A.1

	
Within 30 days after the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to oversee and coordinate the Parties’ activities under this Agreement with respect to development, pre-commercialization, commercialization and manufacture activities with respect to the Licensed Products in the Field of Use in the Territory.  The JSC shall also be a forum for the exchange of information regarding the Parties’ performance of their respective obligations under the applicable development and commercialization plans. The JSC shall facilitate, coordinate, support and oversee the Parties’ cooperative efforts in order to achieve the mutually desired objective of speed, efficiency and coordination regarding the Parties’ research, development, manufacturing and commercialization activities hereunder.  Each Party’s JSC members shall disclose to the other Party’s JSC members all significant issues and decisions related to the research, development, manufacturing and commercialization of the Licensed Product in or for the Territory. To avoid doubt, the Parties acknowledge that the JSC is intended to be an advisory body only.

	
2A.2

	
Without limiting the foregoing, Licensee’s JSC members shall (i) provide Licensor’s JSC members with periodic reports concerning all material activities undertaken in respect of Licensee’s exercise of the manufacturing rights granted to Licensee under this Agreement, (ii) at Licensor’s request, from time to time, provide Licensor’s JSC members with further information relating to Licensee’s activities in exercise of the manufacturing rights granted to Licensee under this Agreement and (iii)  provide Licensor’s JSC members with periodic reports concerning all material activities undertaken in respect of Licensee’s development, pre-commercialization and commercialization activities of Licensed Product. During the period between the Effective Date and the date of the First Sale, Licensee’s JSC members shall provide the reports specified in (i) and (iii) above not less than once every three months; thereafter, the reports shall be provided not less than once every six months.

	
2A.3

	
Each Party shall initially appoint two representatives to the JSC, each of whom will have sufficient seniority and expertise within the applicable Party to make decisions arising with the scope of the JSC’s responsibilities.  The JSC may change its size from time to time by mutual consent of the Parties.  Each Party may replace its JSC representatives at any time upon written notice to the other Party.  The JSC may invite non-members to participate in the discussions and meetings of the JSC where appropriate (and subject to such individuals being subject to mutually acceptable binders of confidentiality), provided that such participants shall have no voting authority at the JSC.  The JSC shall have a chairperson who shall be selected by Licensor.  The role of the chairperson shall be to convene and preside at meetings of the JSC and to ensure the preparation of minutes, but the chairperson shall otherwise have no additional powers or rights beyond those held by the other JSC representatives.

 

  

7

  

	
2A.4

	
The JSC shall meet at least quarterly during the Term unless the Parties mutually agree in writing to a different frequency for such meetings; provided that during the period between the Effective Date and the date of the First Sale, there should be face-to-face in-person meetings at least twice per year at a location and time agreed by the Parties and thereafter, there should be such a meeting at least once per year.  No later than 15 days prior to any regularly scheduled meeting of the JSC, the chairperson of the JSC shall prepare and circulate an agenda for such meeting and, as soon as practicable, materials for the meeting; provided, however, that either Party may propose additional topics to be included on such agenda prior to such meeting.  The JSC may meet in person, by videoconference or by teleconference.  Each Party will bear the expense of its respective JSC members’ participation in JSC meetings.  Meetings of the JSC shall be effective only if at least one representative of each Party is present or participating in such meeting.  The chairperson of the JSC will be responsible for preparing reasonably detailed written minutes in English of all JSC meetings that reflect, without limitation, material decisions made at such meetings. The JSC chairperson shall send draft meeting minutes to each member of the JSC for review within 15 days after each JSC meeting.  The members of the Committee shall have 15 days to provide comments.  The JSC chairperson shall incorporate timely received comments and distribute revised minutes to all members of the JSC for their final review and approval within the later of 45 days after the relevant meeting or the next regularly scheduled meeting of the JSC.

	
3.

	
Consideration for Licensed Products[*]

	
3.1

	
a.

	
With respect to the Licensed Products referred to in Section 7.2, in consideration for the exclusive license granted to Licensee under Section 2.1, for each Licensed Product unit sold by Licensee and its Sublicensees in a given calendar quarter, Licensee will pay Licensor an amount equal to [*]

	
  

	
b.

	
With respect to the Licensed Products referred to in Section 7.2, in consideration for the exclusive license granted to Licensee under Section 2.1, for each Licensed Product unit sold by Licensee and its Sublicensees in a given calendar quarter, Licensee will pay Licensor an amount equal to [*].

 

	
  

	
c.

	
For the purpose of this Agreement:

	
  

	
(i)

	
“Licensed Product unit sold” means each Licensed Product that is invoiced by Licensee and its Sublicensees for a value higher than zero and that has not been returned to and credited by Licensee and/or its Sublicensees.

	
  

	
(ii)

	
[*]

	
  

	
(iii)

	[*]

	
3.2

	[*]

 

  

8

  

 

	
3.3

	
[*]

	
3.4

	
Within twenty-five (25) days of the end of each calendar quarter, Licensee shall deliver to Licensor a report summarizing the previous calendar quarter’s Licensed Product units sold together with a calculation of the payments due pursuant to Section 3.1 (the “Report”). Upon the basis of the Report, Licensor shall issue an invoice to Licensee for the payments due for the previous calendar quarter. Such invoice will be in EUR and will be paid by Licensee no later than the end of the calendar month following the month in which such invoice is issued. [*] Licensor reserves the right to inspect Licensee’s written records supporting such Reports or payments delivered as part of an examination performed in accordance with Section 4.1 below.

	
3.5

	
[*]

	
3.6

	
Licensee will pay to Licensor interest on late payments computed at the rate of one percent (1%) per month, or the maximum interest rate permitted by applicable law, whichever is less, on each overdue, unpaid amount, in each calendar month that such payment is overdue.

	
3.7

	
For purposes of this Agreement, the word “Tax(es)” means any tax (other than income tax), duty, tariff or other governmental charge levied on the sale of a Licensed Product, including consumption tax.  If any payment required to be made by Licensee to Licensor hereunder is subject to a deduction of Tax or withholding Tax, then, subject to the second paragraph of this Section 3.7, the sum payable by Licensee (in respect of which such deduction or withholding is required to be made) shall be made to Licensor after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount shall be remitted in accordance with applicable laws.  In all events, it is acknowledged that Licensee may deduct and withhold the required Taxes from payments due to Licensor in the event of any changes in Tax law, administrative interpretations or treaties that may change current rules as applicable to such payments or as a consequence of a tax audit imposing such deduction of Tax or withholding Tax on Licensee, subject to providing Licensor with at least sixty (60) days’ advance notification of the intention to withhold such Taxes and giving Licensor an opportunity to provide a written Tax opinion or other form of evidence that such Taxes should not be withheld, which will be given reasonable consideration by Licensee; and subject further, in the case of an audit, to providing Licensor with reasonably sufficient notice of the intention of a taxing authority to carry out an audit in order that Licensor may participate in any negotiations with such authority and otherwise be permitted to influence the amount of the withholding, if any, and the payment terms.

 

  

9

  

 

The Parties shall use all reasonable and legal efforts to reduce or eliminate Tax withholding or similar obligations in respect of all payments made by Licensee to Licensor under this Agreement.  To the extent Licensee is required to deduct and withhold taxes on any payment to Licensor, Licensee shall pay the amounts of such Taxes to the proper Governmental Authority in a timely manner and promptly transmit to Licensor an official Tax certificate or other documentation of the payment of any such withholding Taxes, including copies of receipts or other evidence reasonably required and sufficient to enable Licensor to document such tax withholdings adequately for purposes of claiming foreign tax credits and similar benefits.  Licensor shall provide Licensee any Tax forms that may be reasonably necessary in order for Licensee to not withhold tax or to withhold Tax at a reduced rate under an applicable bilateral income Tax treaty.  Licensor shall use reasonable efforts to provide any such tax forms to Licensee at least thirty (30) days prior to the due date for any payment for which Licensor desires that Licensee apply a reduced withholding rate.  Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable law, of withholding Taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding Tax or value added Tax.  Licensee shall require its Sublicensees to cooperate with Licensee in a manner consistent with this Section 3.7.

	
3.8

	
To the extent legally enforceable, and as additional consideration for the exclusive license granted in Section 2.1, Licensee hereby agrees, during the Term, that if the validity, enforceability or patentability of any of the Licensed Patents is challenged by Licensee or any of its Sublicensees, and such challenge is not discontinued within thirty (30) days after initiation, Licensor reserves the right to immediately terminate this Agreement upon delivery of written notice of termination to Licensee.

 

	
4.

	
Records

	
4.1

	
Licensee will keep accurate books of account and records pertaining to all payment reports and payments due to Licensor under this Agreement (“Records”).  Upon Licensor’s written request, but not more frequently than once per calendar year, an independent accounting firm retained by Licensor, at Licensor’s expense, will have the right during Licensee’s normal business hours to examine such Records in the possession and under the control of Licensee.  Such independent accounting firm may be required to execute a confidential disclosure agreement with Licensee.  Such examination of Records will be conducted with at least twenty-one (21) days’ prior written notice to Licensee (provided that the examination of Records shall never take place during the first calendar month following the end of a calendar quarter), for the sole purpose of and only to the extent necessary to verify such payment reports and payments required under this Agreement. Licensor has the right to examine Records that were created within five (5) years of the date of Licensor’s request.  Licensee will keep its Records in such a manner as to facilitate such examination.  In the event that such independent accounting firm discovers any inconsistencies, mistakes, under-reporting or under-payment in such Records, a copy of the independent accounting firm’s written report will be delivered to Licensee.  Licensee will pay to Licensor, within thirty (30) days of Licensee’s receipt of such written report, all such undisputed amounts overdue and unpaid, and Licensor will promptly grant a credit or refund to Licensee in the case of any overpayment.  If it is determined that there is a deficiency of five percent (5%) or more in the payments actually paid to Licensor versus the amount of payments owed to Licensor in any given calendar quarter, then Licensee will bear all reasonable expenses related to such examination by Licensor’s accounting firm.  Licensee will conduct an examination of its Sublicensees’ payment reports upon Licensor’s reasonable written request, but not more frequently than once per calendar year for any given Sublicensees, which Licensor request shall identify the Sublicensee to be audited by Licensee.

 

  

10

  

 

	
4.2

	
All such Records pertaining to Reports and payments due to Licensor under this Agreement will be kept available for at least five (5) years after the calendar year to which they relate, and Licensor’s right under this Agreement to examine such Records in accordance with Section 4.1 and this Section 4.2 will survive the expiration or termination of this Agreement.

5.            Patents and Trademarks.

 

	
5.1

	
Prosecution and Enforcement of Licensed Patents; Inventions and New IP.

	
  

	
a.

	
As between the Parties, Licensor will have the sole right, at its sole expense, to prepare, file, prosecute and maintain all Pending Patent Applications and Issued Patents within the Licensed Patents.  For preparation, filing, prosecution and maintenance costs incurred for Pending Patent Applications and Issued Patents in the countries of the Territory listed in Schedule D from and after the Effective Date (“Territory Patent Costs”), Licensee will reimburse such Territory Patent Costs within forty-five (45) days after receipt of invoice from Licensor, it being understood that the total Territory Patent Costs (not including the renewal fees) to be reimbursed by the Licensee during the Term shall be limited to a maximum of EUR [*] and any Territory Patent Costs (other than renewal fees) exceeding the EUR [*] shall be for the account of Licensor. For the avoidance of doubt, the maximum payment set forth above does not apply to renewal fees, if any, and the responsibility of Licensee for renewal fees shall continue until earlier of the expiration of the patent or the termination or expiration of this Agreement. [*]

 

	
  

	
b.

	
During the Term, Licensor will have the sole right, at its sole expense, to determine the appropriate course of action against any third parties infringing any Licensed Patents in the Field of Use in the Territory.  All of the proceeds of any such enforcement action will be retained by Licensor.  At Licensor’s request and expense, Licensee shall reasonably cooperate with Licensor during the Term in connection with any enforcement action brought under this Section 5.1(b), and in particular, agrees to be joined as a party plaintiff, at Licensor’s expense, if any such joinder is needed for Licensor to bring or continue an infringement action hereunder.

 

	
  

	
c.

	
Licensor shall own all Inventions, and Licensee will cooperate, and cause its Sublicensees to cooperate, to ensure that all Inventions are assigned to Licensor.  Any and all other new intellectual property rights (a) arising in the course of use, practice and/or exploitation of the license rights granted to Licensee under this Agreement (including but not limited to information, know-how, data, designs, methods, processes, techniques, materials, formulae, trade secrets, patents and patent applications and other proprietary information), (b) identified, developed, generated or obtained by Licensee or its Sublicensees, and (c) related to Licensed Patents, Licensed Technology or Licensed Products (collectively, (a-c) are referred to as “New IP”) shall be owned by and assigned to Licensor.  All Inventions and all New IP will be included automatically within Licensed Patents or Licensed Technology (as applicable) and included in the license granted to Licensee under Section 2.1.

 

  

11

  

 

	
  

	 

	
5.2

	
Upon execution of this Agreement, Licensee will reimburse Licensor for past intellectual property costs associated with the Licensed Product incurred to date in the amount of [*].

	
5.3

	
a.

	
All Trademarks will be owned and maintained by Licensee, at its own expense. Licensee has the right to decide which Trademarks and artwork will be used for the Licensed Products.

	
  

	
b.

	
Licensor acknowledges Licensee’s rights to the artworks of the Licensed Products and the Trademarks affixed to the Licensed Products and all (other) intellectual property rights (including but not limited to copyrights and design rights) regarding the sale, marketing and distribution of the Licensed Products in the Territory. Licensor acknowledges that none of Licensee’s rights in the artworks of the Licensed Products and the Trademarks affixed to the Licensed Products belong to Licensor. Licensee retains the right to use the Trademarks and the artwork during the term of this Agreement and after termination of this Agreement for whatever product it chooses, it being understood that Licensee’s right to use the Trademarks and the artwork in connection with Licensor’s applicator shall end upon the exhaustion of the remaining inventory as provided in Section 13.1.

 

	
  

	
c.

	
During and after termination of the Agreement, Licensor shall not use any trademark, trade name and/or artworks similar to the Licensee’s artworks of the Licensed Products and the Trademarks affixed to the Licensed Products in respect of any product and shall not register or procure the registration of any trademark similar to the Trademarks for any class of goods in any country of the world.

	
  

	
d.

	
Licensee shall be entitled to conduct all proceedings relating to its intellectual property and shall at its sole discretion decide what action, if any, to take in respect of any infringement, enforcement or alleged infringement of such intellectual property or any other claim or counter-claim brought or threatened in respect of the use, prosecution or registration of the Licensee’s intellectual property. Any such proceedings shall be conducted at Licensee’s expense and for its own benefit.

	
  

	
e.

	
Licensee is entitled to use its own name, the logo as described in Schedule E (the “Omega Pharma Logo”), variants of the Omega Pharma Logo or any other logo with a reasonable size on the Products. All such logos shall at all times remain the sole property of Omega Pharma NV, during and after expiry of this Agreement. Licensee shall be entitled to conduct all proceedings relating to the abovementioned logos and shall at its sole discretion decide what action, if any, to take in respect of any infringement, enforcement or alleged infringement of the abovementioned logos or any other claim or counter-claim brought or threatened in respect of the use, prosecution or registration of the abovementioned logos. Any such proceedings shall be conducted at Licensee’s expense and for its own benefit.

 

  

12

  

 

	
  

	
f.

	
On the termination of this Agreement for any reason, Licensor shall, to the extent applicable, immediately cease to use in any way any logo of Licensee.

	
6.

	
Manufacturing

	
6.1

	
a.

	
Licensee will make all necessary efforts to launch a Licensed Product commercially in the Territory in 2016, including an obligation of Licensee to have secured sufficient Licensed Product supply to support such commercial launch.  [*]

 

	
  

	
b.

	
If Licensee fails to launch a Licensed Product commercially in the Territory within the timing specified above and such failure is attributable to Licensee, Licensor shall have the right to terminate this Agreement. Licensee shall cause its agreement with any Third Party for the manufacture of Licensed Product to provide that in such event, (a) Licensor will have the right to request from such Third Party a new agreement for manufacturing services on terms at least as favorable as those set forth in Licensee’s agreement for comparable volumes, and (b) the ownership of manufacturing equipment owned by Licensee (e.g., molds) shall be transferred to Licensor. The Parties agree that the remedies provided for in this Section shall be the only remedies for failure to launch a Licensed Product commercially in the Territory within the timing specified above. Licensor agrees that it cannot and shall not claim compensation of whatever kind if Licensee has not launched a Licensed Product commercially in the Territory during the timing specified above.

	
  

	
c.

	
[*]

	
6.2

	
Licensor will be provided full access to all know-how and information Controlled by Licensee and related to Licensed Product commercial manufacturing activities and technologies, including but not limited to the know-how and information needed to establish the relevant manufacturing facilities (“Manufacturing Information”).  Without limiting the foregoing, Licensor may use such Manufacturing Information in connection with engagement of a contract manufacturing organization to produce Licensed Product for Licensor, such that Licensor (and/or its other licensees) are able to commercialize Licensed Product (a) in all fields in countries not included in the Territory, and (b) outside the Field of Use throughout the world (including, but not limited to, in the Territory). In order to carry out its obligations pursuant to this Section, Licensee will ensure that its agreements with Third Parties provide for access to such Third Parties’ Manufacturing Information both during the term of any agreements with such Third Parties and thereafter (by means of escrow agreements or arrangements with a similar purpose). Upon Licensor’s request, Licensee shall provide Licensor with a copy of each supply agreement with a Third Party.

 

  

13

  

 

	
7.

	
Development and Commercialization in the Territory; Diligence

	
7.1

	
During the Term, and provided that Licensee is not in material breach of the terms of this Agreement (and in particular, not in breach of Licensee’s development, manufacturing investment and diligence obligations), Licensee will be the sponsor and legal manufacturer of Licensed Products in the Territory.  Licensee is obligated to undertake, and to fully fund, the development activities that are required to obtain regulatory approval for Licensed Products throughout the Territory.

	
7.2

	
a.

	
During the Term, Licensee will use its diligent and commercially reasonable best efforts to develop and obtain regulatory approval for at least one Licensed Product, for at least two OTC indications [*], in the Field of Use in the Territory.  If Licensee wishes to change either of such indications, it must obtain Licensor’s prior written approval to do so.   [*]

	
  

	
b.

	
In the event that any delays, which are not attributable to Licensee, prohibit Licensee to obtain the regulatory approval within the timing specified above, the Parties agree to negotiate an extension of the timing in good faith, provided that there may be only one such extension of not more than two calendar quarters.

	
  

	
c.

	
If Licensee fails to obtain any of the regulatory approvals within the timing specified above and such failure is attributable to Licensee, Licensor shall have the right to terminate this Agreement. Licensee shall cause its agreement with any Third Party for the manufacture of Licensed Product to provide that in such event, Licensor will have the right to request from such Third Party a new agreement for manufacturing services on terms at least as favorable as those set forth in Licensee’s agreement for comparable volumes. The Parties agree that the remedies provided for in this Section shall be the only remedies for failure to obtain any of the regulatory approvals within the timing specified above. Licensor agrees that it cannot and shall not claim compensation of whatever kind if Licensee has not obtained any of the regulatory approvals during the timing specified above.

	
7.3

	
During the Term, Licensee will use its diligent and commercially reasonable best efforts to commercialize at least one Licensed Product, for the same two OTC indications described in Section 7.2, in the Field of Use in the Territory.  [*] Upon regulatory approval for each Licensed Product, Licensee will use its diligent and commercially reasonable best efforts, and will cause its Sublicensees to use their diligent and commercially reasonable best efforts, to promote, market and sell such Licensed Product throughout the Territory.  [*]

 

	
7.4

	
Licensee shall prepare marketing plans for the Territory (the “Licensee Marketing Plans”), which shall include plans related to the pre-launch, launch, promotion and commercialization activities pertaining to each Licensed Product in the Territory.  Licensee shall share with Licensor the Licensee pre-marketing and Marketing Plans on a regular basis. During the period between the Effective Date and the date of the First Sale, Licensee shall provide such Plans not less than once every six months; thereafter, the reports shall be provided not less than once per year. In addition, Licensee shall keep Licensor informed, upon reasonable request by Licensor, with respect to commercialization of the Licensed Products in the Territory.  Licensee shall have full control and authority over of the day-to-day commercialization of the Licensed Products in the Territory and implementation of the corresponding Marketing Plans, at Licensee’s sole expense.

  

 

 

14

  

	
7.5

	
For purposes of harmonization and coordination of global commercialization of the Licensed Products, each Party shall keep the other Party informed regarding the preparation of promotional materials, samples, advertising and materials for training sales representatives with respect to commercialization of the Licensed Products.  Upon reasonable request of a Party, the other Party shall provide copies of such Product-related written materials.  Licensee shall have sole responsibility for the Licensed Product marketing materials used in the Territory.  Each Party shall preserve the confidentiality of information and materials exchanged.

	
7.5

	
The copyright in any advertising material (including commercials) and literature acquired or designed by or coming into the possession of Licensee and designed, written or produced specifically for the purpose of the promotion of sales of the Licensed Products shall be the sole and exclusive property of Licensee, unless specifically paid for by Licensor and agreed between the Parties that the material is the property of Licensor.

	
8.

	
Data Access and Sharing

 

	
8.1

	
Licensor will have full access, at no cost to Licensor, to all clinical and research and development data generated during Licensee’s performance of its development plan for Licensed Product (“Licensee Data”).  Licensor may use these Licensee Data in connection with development and/or licensing of Licensed Product in territories outside the Territory, and in fields outside of the Field of Use.  Licensee Data also may be requested or used by Licensor to fulfill Licensor’s obligations to the Upstream Licensor.

 

	
8.2

	
During the Term, Licensee will have access to any additional clinical and research and development data generated by Licensor following the Effective Date and pertinent to development and/or commercialization of Licensed Products.

9.            Confidential Information

	
9.1

	
The Parties agree that during the Term, and for a period of five (5) years after this Agreement expires or terminates, the Receiving Party will (a) maintain all Confidential Information of the Disclosing Party in confidence to the same extent the Receiving Party maintains its own confidential or proprietary information or trade secrets of similar kind and value; (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for Licensee’s disclosures to its Sublicensees who agree to be bound by obligations of non-disclosure and non-use at least as stringent as those contained in this Article 9; and (c) not use such Confidential Information for any purpose except those purposes permitted by this Agreement.  A Party will not knowingly disclose to the other Party any Third Party information or know-how that such Party does not have the legal right to disclose to the other Party and/or which it has a contractual obligation not to disclose to the other Party.

 

  

15

  

 

	
9.2

	
Notwithstanding the foregoing Section 9.1, a Receiving Party may disclose Confidential Information of the Disclosing Party:

 

	
  

	
a.

	
to the extent and to the persons and entities as required by an applicable law, rule, regulation, legal process, court order or the rules (i) of the any securities exchange on which any security issued by either Party is traded or (ii) of a regulatory authority; or

 

	
  

	
b.

	
in the case of Licensor, as necessary to file, prosecute or defend Licensed Patents; or

 

	
  

	
c.

	
to prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement, but only to the extent that any disclosure is necessary.

 

The Receiving Party required or intending to disclose the Disclosing Party’s Confidential Information under Section 9.2(a) or (c) shall give advance written notice to the Disclosing Party of such required disclosure, so that the Disclosing Party may seek a protective order or other appropriate remedy or to undertake steps to avoid or limit disclosure.  If, in the absence of a protective order or other remedy, or an avoidance of disclosure, the Receiving Party is nonetheless, in the reasonable opinion of Receiving Party’s counsel, required to disclose Confidential Information of the Disclosing Party under Section 9.2(a) or (c), the Receiving Party may disclose only that portion of the Confidential Information of the Disclosing Party which such counsel advises in writing is legally required to be disclosed; provided that the Receiving Party shall preserve the confidentiality of such Confidential Information to the fullest extent possible, including, without limitation, by cooperating with the Disclosing Party in its efforts to secure confidential or protective treatment of such Confidential Information.

	
9.3

	
A Receiving Party may disclose Confidential Information received under this Agreement to existing or potential investors, acquirers, merger partners, collaborators, consultants, contractors, distributors or licensees, or to professional advisors (e.g., attorneys, accountants and investment bankers) involved in such activities, for the limited purpose of evaluating such investment, transaction, or license and under appropriate conditions of confidentiality, only to the extent necessary and with the agreement by these permitted individuals to maintain such Confidential Information in strict confidence.

 

	
9.4

	
The Parties have mutually agreed upon the text of a press release announcing the execution of this Agreement. Such press release is attached to this Agreement as Schedule F.  Except for such mutually agreed initial press release, neither Party shall (a) originate any publicity, news release or other public announcement, written or oral, whether to the public press, stockholders or otherwise, relating to this Agreement, any amendment hereto or performance hereunder, or (b) use the name of the other Party in any publicity, news release or other public announcement, except (i) with the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, or (ii) as required by applicable law (including securities laws and regulations), in which case the Party wishing to issue the public disclosure (the “Initiating Party”) shall submit to the other Party (for review and any proposed modifications, as well as the Parties’ coordination, prior to such disclosure or use) each such required disclosure, and shall comply with the terms of this Article 9.  In this respect, the other Party will use its good faith and Commercially Reasonable Efforts to provide to the Initiating Party its comments on the proposed public disclosure within forty-eight (48) hours of receipt, and the Initiating Party will reasonably consider the other Party’s comments thereon if such comments are received within such forty-eight (48) hour period.  Either Party may disclose the existence of this Agreement; however, the terms and conditions of this Agreement shall be deemed to be the Confidential Information of each Party.

 

  

16

  

 

	
10.

	
Representations and Warranties; Indemnification

	
10.1

	
Each Party hereby represents and warrants to the other Party that, as of the Effective Date:

 

	
  

	
a.

	
it is duly organized and validly existing under the laws of its state of incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

 

	
  

	
b.

	
it is has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement;

 

	
  

	
c.

	
this Agreement is legally binding upon it and enforceable in accordance with its terms; and

 

	
  

	
d.

	
its execution, delivery and performance of this Agreement does not conflict with, constitute a breach of, or in any material way violate any arrangement, understanding or agreement to which it is a party or by which it is bound.

	
10.2

	
Licensor hereby represents and warrants that: (a) as of the Effective Date, (i) the Upstream License Agreement is in full force and effect; (ii) Licensor has been granted all the licenses and rights under the Upstream License Agreement which are necessary for granting the licenses and right to Licensee hereunder; (iii) Licensor is not in breach with respect to material obligations under the Upstream License Agreement; and (iv) execution and performance of this Agreement shall not constitute breach of any provisions of the Upstream License Agreement; and (b) during the Term, (i) Licensor shall fulfill its obligations under the Upstream License Agreement; (ii) if Licensor seeks any modification, amendment or revision to the Upstream License Agreement, Licensor shall obtain prior written consent of Licensee to the extent such modification, amendment or revision will affect Licensee’s license and rights hereunder; and (iii) Licensor shall not terminate the Upstream License Agreement in whole or with respect to the Territory, without prior written consent of Licensee.

 

	
  

	
Licensor hereby furthermore: (i) warrants that it shall not grant to any Third Party any rights under the Licensed Patents and/or  Licensed Technology to make, use, sell, offer to sell, import and otherwise exploit products within the Field of Use in the Territory during the term of the Agreement; and (ii) represents that as of the Effective Date, (a) the Licensed Technology complies with the specifications and characteristics as set forth in the documentation attached as Schedule G; and (b) to its knowledge, the Licensed Technology (as available on the Effective Date) and the Licensed Patents do not infringe any intellectual property rights of a Third Party.

  

 

17

  

	
10.3

	
a.

	
Licensee will indemnify, hold harmless, and defend Licensor and its directors, officers, employees, agents, and independent contractors (collectively, the “Licensor Indemnitees”) from any and all liability, loss, damage, cost, and expense, including reasonable attorneys’ fees and costs (collectively, “Losses”) that a Licensor Indemnitee becomes legally obligated to pay because of any Third Party claim or suit to the extent that such claim or suit arises from (a) the use, practice and/or exploitation of the Patents, Licensed Technology or Trademarks by Licensee or its Sublicensees, or by their respective directors, officers, employees, agents, independent contractors, or Sublicensees, (b) the manufacture, use, offer for sale, sale or importation of Licensed Products by or on behalf of Licensee or its Sublicensees, or otherwise in the conduct of Licensee’s business, (c) Licensee’s breach of its obligations or its representations and warranties under this Agreement, or (d) the negligence, recklessness, or willful misconduct of Licensee or any of its directors, officers, employees, agents, independent contractors and Sublicensees; except in each case to the extent that such Third Party claim or suit results from the negligence, recklessness, or willful misconduct of Licensor or any of its directors, officers, employees, agents or Licensor’s breach of its obligations or its representations and warranties under this Agreement.

	
  

	
b.

	
Licensor will indemnify, hold harmless, and defend Licensee and its Sublicensees and their directors, officers, employees, agents, and independent contractors (collectively, the “Licensee Indemnitees”) from any and all liability, loss, damage, cost, and expense, including reasonable attorneys’ fees and costs (collectively, “Losses”) that a Licensee Indemnitee becomes legally obligated to pay because of any Third Party claim or suit to the extent that such claim or suit arises from (a) Licensor’s breach of its obligations or its representations and warranties under this Agreement or (b) the negligence, recklessness, or willful misconduct of Licensor or any of its directors, officers, employees, agents and independent contractors; except in each case to the extent that such Third Party claim or suit results from the negligence, recklessness, or willful misconduct of a Licensee Indemnitee or Licensee’s breach of its obligations or its representations and warranties under this Agreement.

 

	
10.4

	
a.

	
Licensee’s agreement to indemnify, hold harmless and defend the Licensor Indemnitees is conditioned upon Licensor: (a) providing written notice to Licensee of any claim, demand, or action arising out of the indemnified activities within thirty (30) days after Licensor has knowledge of such claim, demand, or action; (b) permitting Licensee to assume full responsibility and authority to investigate, prepare for, and defend against any such claim or demand; and (c) assisting Licensee, at Licensee’s reasonable expense, in the investigation of, preparation for, and defense of any such claim or demand.

	
  

	
b.

	
Licensor’s agreement to indemnify, hold harmless and defend the Licensee Indemnitees is conditioned upon Licensee: (a) providing written notice to Licensor of any claim, demand, or action arising out of the indemnified activities within thirty (30) days after Licensee has knowledge of such claim, demand, or action; (b) permitting Licensor to assume full responsibility and authority to investigate, prepare for, and defend against any such claim or demand; and (c) assisting Licensor, at Licensor’s reasonable expense, in the investigation of, preparation for, and defense of any such claim or demand.

 

  

18

  

 

	
10.5

	
IN NO EVENT WILL A PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, PUNITIVE, INCIDENTAL, CONSEQUENTIAL, LOST PROFIT, OR INDIRECT DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, AND REGARDLESS OF WHETHER THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.  THE FOREGOING LIMITATION SHALL NOT APPLY, HOWEVER, TO LICENSEE’S OR LICENSOR’S INDEMNIFICATION OBLIGATIONS PURSUANT TO THIS ARTICLE 10 OR TO LIMIT THE DAMAGES AVAILABLE FOR BREACHES OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 9.

	
11.

	
Term

	
  

	
This Agreement will commence on the Effective Date and will continue in effect until the cessation of all commercialization in the Territory, unless terminated by either Party by written notice in accordance with the provisions of Article 12.  On the expiration of all the Licensed Patents applicable to a given country in the Territory, (a) the license granted to Licensee under such Licensed Patents and the Licensed Technology in such country shall become fully-paid, royalty-free (i.e., no further payment will be due by Licensee to Licensor as per Articles 3.1, 3.2, 3.3 and 3.4 except for any amounts for the which the obligation to pay arose before the expiration of the Licensed Patents) and non-exclusive, and (b) Licensor and the Upstream Licensor shall be free to use such Licensed Patents and the Licensed Technology to make, use, sell, offer to sell, import and otherwise exploit Products and to grant others licenses to do the same in the Territory.

 

	
12.

	
Termination

	
12.1

	
Following the fifth anniversary of the First Sale, either party shall be entitled to terminate this Agreement by written notice at least eighteen (18) months prior to the proposed date of termination.

	
12.2

	
This Agreement may be terminated by either Party upon sixty (60) days written notice to the other Party specifying a material breach of this Agreement by such other Party and demanding its cure, if such material breach has not been cured to the reasonable satisfaction of the non-breaching Party on or before such 60th day; provided, however, if such breach is not capable of cure within such 60-day period and the breaching Party is acting diligently to accomplish a timely cure, this Agreement will not terminate until the expiration of a reasonable period for the completion of the cure to the reasonable satisfaction of the non-breaching Party, but, in any event, not more than 90 days after the date the notice of breach is delivered to the breaching Party.

 

  

19

  

 

	
12.3

	
If Licensee files a petition in bankruptcy or is adjudicated as bankrupt or if a petition in bankruptcy is filed against Licensee or if it becomes insolvent, or makes an assignment for the benefit of its creditors or an arrangement pursuant to any bankruptcy law, and such proceeding is not dismissed within 60 days, or if Licensee discontinues all of its business or if a receiver is appointed for it or its business, this Agreement will terminate immediately upon written notice by Licensor.

	
12.4

	
This Agreement may be terminated with immediate effect by either Party upon written notice to the other Party if there is a Change of Control of the other Party.  If a Change of Control occurs on a Party, such Party shall provide written notice to the other Party of the Change of Control event no later than three (3) business days after the occurrence of such Change of Control event.

	
  

	
The Licensor acknowledges that the shareholders of Licensee have publicly announced that they have entered into a definitive agreement on the acquisition by Perrigo Company Plc of the share capital of Omega Pharma Invest NV (Licensee’s ultimate holding company) (the “Perrigo Transaction”). Licensor furthermore acknowledges and accepts that the closing of the Perrigo Transaction will give rise to a Change of Control event of Licensee, of which Licensor shall be notified pursuant to this Section12.4 (the “Perrigo Change of Control Event”).  It is explicitly confirmed between the Parties that the occurrence of the Perrigo Change of Control Event shall not give rise to a right to terminate this Agreement.  The Agreement shall remain in full force and effect and each of Licensor and Licensee shall continue after the Perrigo Change of Control Event to fulfil their respective rights and obligations under this Agreement.

 

	
12.5

	
Other than as expressly provided for in this Agreement and except in the event of termination because of breach, it is expressly agreed and accepted by the Parties that under no circumstances will the act of termination of this Agreement in accordance with the provisions of this Article 12 entitle either Party to any kind of compensation, damages, loss of profits, or otherwise.  Notwithstanding the foregoing, the termination of this Agreement in accordance with the provisions of this Article 12 will be without prejudice to the accrued or antecedent rights and obligations of the Parties as of the effective date of termination.

	
13.

	
Effect of Termination or Expiration

 

	
13.1

	
Upon termination of this Agreement in accordance with Article 12, the license granted under Section 2.1 will automatically terminate and Licensee will cease all use of the Licensed Patents and Licensed Technology.  Notwithstanding anything to the contrary in the foregoing, except in the event of Licensor’s termination of this Agreement for Licensee’s uncured breach, Licensee and its Sublicensees shall be allowed to sell all remaining Licensed Product units in their respective inventory within six (6) months after the effective date of termination and within twelve (12) months after the effective date of termination if Licensee has terminated the Agreement for Licensor’s uncured breach, subject to Licensee’s payment(s) to Licensor pursuant to Article 3.

 

  

20

  

 

	
13.2

	
Upon termination or expiration of this Agreement, Licensee shall deliver to Licensor all data, results, technology, and information of any type whatsoever, in any tangible or intangible form, that is Controlled by Licensee and is necessary or useful for research, development, regulatory or clinical activities, manufacture, commercialization or other use or exploitation of Licensed Product in the Field of Use, including (but not limited to) know-how, trade secrets, practices, techniques, methods, devices, instruments, designs, systems, materials, strategies and expertise, test data and other technical data, as well as regulatory filings and draft applications for regulatory filings and manufacturing rights and technology (including complete Manufacturing Information and the right of Licensor to become the legal manufacturer of Licensed Products (with the full cooperation of Licensee)).

	
14.

	
Notices

	
14.1

	
All notices, requests, consents and other communications given or made by a Party under this Agreement shall be in writing and shall be deemed given (a) five (5) days after mailing when mailed (by registered or certified mail, postage paid, only), (b) on the date sent when made by facsimile transmission with confirmation of receipt (with hard copy to follow by registered or certified mail, postage paid, only), or (c) on the date received when delivered in person or by reputable overnight courier; provided that notices and communications with respect to administrative matters under this Agreement (but not legal matters or matters pertaining to rights or obligations under this Agreement), may be provided by e-mail and will be deemed given when sent.  All notices shall be provided to the address set forth below or such other place as such Party may from time to time designate in writing:

 

	
  

	
If to Licensor:

	
BioLineRx, Ltd.

 

19 Hartum Street

Jerusalem 9777518, Israel

Attention:  Chief Financial and Operating Officer

Facsimile: +972-2-548-9101

E-Mail: phils@biolinerx.com

 

	
  

	
If to Licensor:

	 
[*]

 

Attention:

Facsimile:

E-Mail:

With a copy to:

Omega Pharma NV

Venecoweg 26

9810 Nazareth

Belgium

Attention: Legal Department

Facsimile: +32 9 381 02 68

E-Mail: anja.vanwinsberghe@omega-pharma.com

 

  

21

  

 

	
  

	
a.

	
All such notices, requests, and other communications are deemed received on the date of receipt by the recipient thereof if received prior to 5:00 p.m. in the place of receipt and such day is a business day in the place of receipt.  Otherwise, any such notice, request, or communication is deemed not to have been received until the next succeeding business day in the place of receipt.

 

	
  

	
b.

	
The provisions above governing the date on which a notice is deemed to have been received by a recipient Party means and refers to the date on which a recipient Party, and not its counsel or other recipient to which a copy of the notice may be sent, is deemed to have received the notice.

 

	
  

	
c.

	
If a notice is tendered pursuant to the provisions of this Agreement and is refused by the intended recipient, the notice will nonetheless be deemed to have been given and is effective as of the date provided in this Agreement.

 

15.           Assignment

	
  

	
This Agreement may not be assigned or otherwise transferred by Licensee without the prior written consent of Licensor, which will not be unreasonably withheld or delayed.  Any permitted assignee of Licensee shall assume all obligations of Licensee under this Agreement in writing.  In the event of a permitted assignment by Licensee, Licensee hereby guarantees the performance by such assignee of Licensee’s obligations under this Agreement.  Any breach by such assignee of any of Licensee’s obligations under this Agreement shall be deemed a breach by Licensee, and Licensor may proceed directly against Licensee without any obligation to first proceed against such assignee.

 

	
  

	
This Agreement may be assigned or otherwise transferred by Licensor without the prior written consent of Licensee, except in the circumstance where there is publicly available information and evidence that Licensor’s proposed assignee is a direct competitor of Licensee’s business to which this Agreement relates (“Competitor”).  If, based upon such publicly available information and evidence, the proposed assignee is likely to be a Competitor, Licensor shall inform Licensee in writing of such proposed assignment to such Competitor.  The Parties shall discuss in good faith and agree on whether or not such proposed assignee is in fact a Competitor, and if so, Licensor shall obtain Licensee’s prior written consent to such assignment to such Competitor, which consent may be withheld in the sole discretion of Licensee. Any assignee of Licensor shall assume all obligations of Licensor under this Agreement in writing. Licensor will give Licensee notice of an assignment no later than three (3) business days after the occurrence of such assignment.

	
16.

	
Dispute Resolution

	
16.1

	
The Parties shall attempt in good faith to resolve any and all disputes that arise between them promptly, voluntarily and amicably.  Any dispute arising between the Parties relating to, arising out of, or in any way connected with this Agreement, or any term or condition hereof, or the performance by either Party of its obligations hereunder (a “Dispute”), whether before or after expiration or termination of this Agreement, which is not settled by the Parties within thirty (30) days after written notice of such Dispute is first given by one Party to the other Party in writing, will be referred to a senior executive designated by Licensor and a senior executive designated by Licensee who are authorized to settle such Dispute on behalf of their respective companies (“Senior Executives”).  The Senior Executives will meet (or confer by telephone or video conference) within thirty (30) days after the end of the initial 30-day period referred to above, at a time and place mutually acceptable to both Senior Executives.  If the Dispute has not been resolved by the Senior Executives within thirty (30) days after the end of the initial 30-day period referred to above (or such longer time period as may be mutually agreed upon by the Senior Executives), the Dispute will be resolved in accordance with the remainder of this Article 16.

 

  

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16.2

	
If a Dispute is not resolved in accordance with Section 16.1, the Parties hereby agree to resolve such Dispute by final and binding arbitration administered under the then-current Rules of Arbitration of the International Chamber of Commerce (“ICC”).

 

	
  

	
a.

	
Commencement of Arbitration Proceeding; Arbitrator.  Following failure of the Senior Executives to resolve a Dispute under Section 16.1, either Party may commence such arbitration proceeding in accordance with this Section 16.2 and the ICC rules, and shall simultaneously notify the other Party in writing of such commencement.  The arbitration shall be conducted by one (1) neutral arbitrator, to be mutually selected by the Parties within thirty (30) days of the commencement of the proceeding; provided that if the Parties are unable to mutually select such arbitrator within such 30-day period, then the Parties shall either mutually agree to extend such period or one neutral arbitrator will be selected by Licensor within such thirty (30) day period, one neutral arbitrator will be selected by Licensee within such thirty (30) day period, and such two selected arbitrators shall, within thirty (30) days after the first two arbitrators have been selected, appoint the single neutral arbitrator who shall preside over the arbitration proceeding.

 

	
  

	
b.

	
Arbitration Proceeding and Venue.  The arbitration and all related hearings, proceedings and written submissions will be in the English language.  The arbitration proceeding shall be held in London, England (unless the Parties mutually agree in writing on a different venue).  Each Party shall bear its own expenses (including the fees and expenses of its attorneys, consultants and witnesses) in connection with the arbitration proceeding, and each Party shall, on an ongoing basis, pay one-half (1⁄2) the fees and expenses of the ICC and the arbitrator(s).

 

	
  

	
c.

	
Decision; Enforcement.  The decision of the arbitrator shall be the sole and exclusive remedy of the Parties, shall be final and shall be fully and irrevocably accepted by the Parties.  The arbitrator shall announce his/her decision and award, and the reasons therefor, in writing.  The prevailing Party may enforce such decision against the other Party in any court having jurisdiction.  In any arbitration proceeding hereunder, the arbitrator will not have the right to modify the terms and conditions of this Agreement.  The Parties will exert reasonable efforts to have the decision and award rendered within six (6) months after a Party commences the arbitration proceeding.

 

	
16.3

	
Notwithstanding the above, to the full extent allowed by law, either Party may bring an action in any court of competent jurisdiction for injunctive relief (or any other provisional remedy) to protect the Parties’ rights or enforce the Parties’ obligations under Article 10 or 13 of this Agreement.  In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining to the validity, construction, scope, enforceability, infringement or other violations of patents or other proprietary or intellectual property rights.

  

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17.          Miscellaneous

	
17.1

	
Entire Agreement.  This Agreement, including the attached schedules, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all previous oral and written agreements, proposals, negotiations, representations, commitments and other communications between the Parties with respect to its subject matter, except the Confidentiality Agreement between the Parties, dated January 14, 2014, which shall continue in full force and effect with respect to disclosures of Confidential Information made prior to the Effective Date of this Agreement.  In the event of any conflict or inconsistency between any provision of any schedule hereto and any provision of this Agreement, the provisions of this Agreement shall prevail.

	
17.2

	
Force Majeure.  Neither Party shall be held liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Agreement, for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including but not limited to fire, floods, earthquake, embargoes, war, acts of war (whether war is declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party; provided, however, that the Party so affected shall use commercially reasonable efforts to avoid or remove such causes of nonperformance, and shall continue to perform hereunder with reasonable dispatch whenever such causes are removed.  Either Party shall provide the other Party with prompt written notice of any delay or failure to perform that occurs by reason of force majeure.  The Parties shall mutually seek a resolution of the delay or the failure to perform as noted above.

 

	
17.3

	
Governing Law.  This Agreement and any Dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of England and Wales, without reference to conflicts of laws principles.

	
17.4

	
Waiver.  The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.

 

  

24

  

 

	
17.5

	
Severability.  If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions of this Agreement shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible.  Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of this Agreement in any other jurisdiction.

	
17.6

	
Amendment.  This Agreement may be amended, or any term hereof may be modified, only by a written instrument duly executed by an authorized representative of each of the Parties.

	
17.7

	
Official Language.  The language of this Agreement and of any documents, papers or proceedings required by or under this Agreement, including any such documents, papers or proceedings that arise under Article 16, shall be English.  Any Party requesting or requiring translations of such documents, papers or proceedings shall bear all costs and expenses of such translations.

	
17.8

	
Independent Contractors.  It is expressly agreed that Licensor and Licensee shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency.  Neither Licensor nor Licensee shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other Party to do so.

	
17.9

	
Fees and Expenses.  Each Party will pay its respective transaction expenses incident to the execution of this Agreement.

 

	
17.10

	
Headings.  Headings used in this Agreement are for reference purposes only and will not be deemed a part of this Agreement or used in the interpretations of the substantive provisions of it.

	
17.11

	
Counterparts.  This Agreement may be executed in one or more counterparts by original, facsimile or electronic (for example, PDF) signature, each of which is deemed an original and all of which together constitute one and the same instrument.

	
17.12

	
Surviving Provisions.  All provisions of this Agreement which by their nature survive the expiration or termination of this Agreement will survive expiration or termination including, but not limited to, Articles 1, 4, 5, 9, 10, 13, 16 and 17; and Sections 2.3, 2.4, 6.2, and 8.1.

  

25

  

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

	
BioLineRx Ltd.

 

/s/ Kinneret Savitsky /s/ Philip Serlin

Signature   

 

Kinneret Savitsky, Ph.D.

CEO

Philip Serlin

Chief Financial and Operating Officer  

 

22 December 2014 

Date                                           

	
 
[*]

 

/s/  Freya Loncin                                

Signature

 

Aubisque BVBA (represented by Freya

Loncin, permanent representative)

 

Director

 

22 December 2014

Date

  

26

  

 

Schedule A

Licensed Patents

 

	
Patent or Patent Application No.

	
Publication No.

	
Date of Filing

	
Title

	
European Patent No. 02775182.5

 

	
EP 1,450,771

 

	
02 October 2002

	
Pharmaceutical Preparations Useful for Treating Tumors and Lesions of the Skin and the Mucous Membranes and Methods and Kits Using Same

	
Israel Patent No. 161177

	
IL 161,177

	
02 October 2002

	
Pharmaceutical Preparations Useful for Treating Tumors and Lesions of the Skin and the Mucous Membranes and Methods and Kits Using Same

	
PCT/IL2013/

050783

 

	  	
15 September 2013

	
Medical Applicator

 

  

27

  

 

Schedule B

Territory

[*]

 

  

28

  

Schedule C

Core Countries (Section 2.2.c)

 

[*]

 

  

29

  

 

Schedule D

List of countries where patents will be registered and verified (Section 5.1.a)

 

[*]

 

  

30

  

 

Schedule E

OMEGA PHARMA LOGO

 

 

  

31

  

 

Schedule F

PRESS RELEASE

For Immediate Release

BioLineRx Out-Licenses Novel Skin Lesion Treatment

to Omega Pharma

- Omega Pharma to develop and commercialize novel skin treatment for

OTC use in Europe and additional selected countries -

- First product expected to reach the market in 2016 -

 

Jerusalem, December 23, 2014 – BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has entered into an exclusive out-licensing agreement with Omega Pharma, one of the largest OTC healthcare companies in Europe, for the rights to BioLineRx’s BL-5010, a novel product for the non-surgical removal of benign skin lesions, for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx will retain the rights to BL-5010 in the United States and the rest of the world. This licensing agreement significantly accelerates the pathway to commercialization for this asset, with the first OTC products expected to enter the market in 2016.

Under the terms of the agreement, Omega Pharma will be responsible for all development activities required to obtain regulatory approval in the licensed territory for at least two OTC indications. In addition, Omega Pharma will sponsor and manufacture the product in the relevant regions, and will have exclusive responsibility for commercialization.

The specific financial terms of the licensing agreement were not disclosed. Omega Pharma will pay BioLineRx an undisclosed amount for each unit sold and BioLineRx will be entitled to certain commercial milestone payments. In addition, BioLineRx will have full access to all clinical and R&D data generated during the performance of the development plan and may use these data in order to develop and/or license the product in other territories and fields of use where it retains the rights.

“We are very pleased to partner with Omega Pharma, a top consumer healthcare company and a leading provider of over-the-counter medicines and healthcare products,” stated Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx. “BL-5010 for the non-surgical removal of benign skin lesions offers a promising alternative to painful and invasive removal treatments. We are looking forward to collaborating with Omega in bringing the first product, based on our effective non-invasive solution, to market as early as 2016.”

 

  

32

  

 

Mr. Marc Coucke, Chief Executive Officer of Omega Pharma, added, “We are happy to collaborate with BioLineRx in adding this promising skin lesion treatment to our leading skin care brands. We were very impressed with the data from the product’s clinical trials to date, and believe it can quickly gain a prominent position as an over-the-counter treatment for a variety of benign skin lesions.”

Dr. Savitsky concluded, “While our strategic focus remains on advancing our lead clinical programs in oncology and inflammation, we believe this partnership, as well as our recent multi-year collaboration with Novartis, add significant value to BioLine and are a testament to our proven ability to identify and develop promising product candidates. In addition to providing capital that allows BioLine to accelerate development of our lead assets, high-profile partnerships such as these validate our business model globally and we believe this makes us well positioned to continue to attract prospective partners for future candidates.”

About BL-5010

BL-5010 is a novel product for the non-surgical removal of benign skin lesions. It offers an alternative to painful, invasive and expensive removal treatments including cryotherapy, laser treatment and surgery. Because the treatment is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia or bandaging. The product has completed a phase 1/2 pilot clinical study for the removal of seborrheic keratosis, which showed excellent efficacy and cosmetic results, and has received confirmation in Europe for the regulatory pathway classification as a medical device Class 2a.

About Omega Pharma

Omega Pharma is an OTC healthcare company headquartered in Belgium with operations in 35 countries across Europe and selected emerging markets. Its products are sold across an extensive network of pharmacies and related retail outlets. With over 2,500 employees, Omega generated sales of more than €1.2 billion in 2013, with more than half of these sales made by its top 20 brands. Perrigo Company plc and Omega recently announced the signing of a definitive agreement for the acquisition of Omega by Perrigo for €3.6 billion.

About BioLineRx

BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial scheduled for completion in mid-2015; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has successfully completed a Phase 1/2 study.

 

  

33

  

 

For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.

 

Various statements in this release concerning BioLineRx’s future expectations, including specifically those related to the development and commercialization of BL-5010, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2013. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:

 

Tiberend Strategic Advisors, Inc.

Joshua Drumm, Ph.D.

jdrumm@tiberend.com

(212) 375-2664

Andrew Mielach

amielach@tiberend.com

(212) 375-2694

Or

Tsipi Haitovsky

Public Relations

+972-3-6240871

tsipih@netvision.net.il

 

  

34

 

Schedule G

SPECIFICATIONS AND CHARACTERISTICS

[*]

 

35

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