Document:

exhibit_4-34.htm

Exhibit 4.34

 

Consulting Agreement

 

This Consulting Agreement (the “Agreement”) is entered into as of January 1, 2014 (the “Effective Date”) by and between BioLineRx Ltd., a company organized under the laws of the State of Israel, with its offices at 19 Hartum Street, P.O. Box 45158, Jerusalem 9777518 (“BioLine”), and Arnon Aharon, M.D., I.D. number 023699796, with an address at 12 Yavne Street, Tel-Aviv 6579111 (“Consultant”).

 

BioLine wishes to receive certain services from Consultant as an independent contractor, and Consultant is willing to provide such services to BioLine as an independent contractor.

 

In consideration of the foregoing and the mutual covenants and conditions hereinafter set forth, the parties agree as follows:

 

	
1.

	
Services. Consultant shall provide BioLine with certain services specified in the attached Exhibit A, in accordance with BioLine’s needs and requirements (the “Services”).  Consultant shall perform Services faithfully, diligently and to the best of Consultant’s skill and ability.

 

	
2.

	
Payment. In consideration for the full performance of the Services by Consultant, BioLine shall pay Consultant NIS 59,000 per month (the “Fees”) for the provision of Services on a full-time basis (as defined in Exhibit A). During the period that Consultant provides less than full time (as set forth in Exhibit A), BioLine shall pay Consultant a portion of the Fees according to the agreed percentage of part-time work. The Fees are inclusive of all taxes, other than VAT. BioLine will not make deductions for taxes or social benefits from any amounts payable to Consultant, and any such taxes and other payments shall be the sole responsibility of Consultant. The Fees will be paid in arrears no later than the ninth day of each calendar month, against presentation of a valid VAT invoice (heshbonit mas) no later than the first day of that month.  If BioLine is required to withhold any taxes at source, any amount withheld shall be deducted from the Fees. BioLine shall also reimburse Consultant for reasonable business expenses incurred by Consultant in providing the Services, in accordance with BioLine’s policies as determined by BioLine from time to time, provided that such expenses have been approved in writing in advance by Consultant’s supervisor. As a condition to reimbursement, Consultant shall be required to provide BioLine with all invoices, receipts and other evidence of expenditures as may be reasonably required by BioLine from time to time.

 

	
3.

	
Options. As additional consideration for the performance of Services, and subject to the approval of the Board of Directors of BioLine and the execution of an option agreement and any other documents reasonably required by BioLine, Consultant shall be granted options to purchase Ordinary Shares par value NIS 0.01 each of BioLine, in the amount set forth in Exhibit A, to be granted pursuant to, and in accordance with, the terms and conditions of the share option plan adopted by BioLine.

 

	
4.

	
Proprietary Information, Confidentiality and Non-Competition. By executing this Agreement, Consultant agrees to the provisions of BioLine’s Proprietary Information, Confidentiality and Non-Competition Agreement attached as Exhibit B hereto. The terms of Consultant’s engagement are personal and confidential, and Consultant undertakes to keep such terms in confidence and shall refrain from disclosing such terms to any third party.

 

	
5.

	
BioLine Equipment.

 

	
5.1.

	
Mobile Phone; Computer. During the term of this Agreement, Consultant shall be entitled to receive a mobile telephone. In addition, during the term of this Agreement, Consultant shall be entitled to receive a laptop computer. Consultant shall use such telephone and computer (together, the “Equipment”) in a standard and reasonable manner, and in accordance with BioLine’s policies. Consultant hereby agrees that any amount due from Consultant to BioLine in connection with the equipment (including charges for use above the authorized limit, compensation for loss or damage of the equipment, etc.) shall be deducted from the Fees owed to Consultant.

 

  

  

  

 

	
5.2.

	
Automobile. BioLine will make available to Consultant an electronic refueling device (Pazomat or equivalent) for his personal car and pay for fuel used by Consultant. In accordance with BioLine policy, the parties will agree on a monthly quota of kilometers for which BioLine will pay fuel costs, and Consultant will be responsible for paying the cost of fuel for kilometers driven over the agreed quota. Any taxes arising out of the payment for fuel by the Company shall be borne by Consultant. Other than as specifically provided in this section, Consultant shall be responsible for all costs of maintenance, repair and insurance of his personal car. The electronic refueling device will be returned to BioLine immediately upon termination of Consultant’s employment with BioLine for any reason, no later than the date of termination. Consultant shall not be entitled to have fuel costs paid by BioLine during unpaid leaves or absences, unless specifically approved by BioLine in writing. During the term of this Agreement, Consultant may request that instead of the arrangement described in this section, BioLine make available to Consultant a company vehicle, leased or owned by BioLine of a type to be agreed on by BioLine and Consultant, in accordance with company policies which may be amended from time to time.

 

	
5.3.

	
BioLine Property. Consultant acknowledges and agrees that the Equipment, email account and any other device or account providing for transmittal and storage of information, which are placed at Consultant’s disposal by BioLine during the term of this Agreement are and shall remain the property of BioLine. Consultant confirms its understanding that BioLine regularly reviews email correspondence and other information transmitted and stored by using the equipment stated above, and BioLine reserves the right to copy, store, present to others, and use such information. Consultant acknowledges and agrees that any messages and data sent from, received by, or stored in or upon BioLine’s computers and communications systems are the sole property of BioLine, regardless of the form and/or content of these messages and data. Consultant should not consider messages and data sent from, received by, or stored in or upon BioLine’s computer and communications systems to be private and should not send, receive, or store sensitive personal or private information using these systems. Consultant is deemed to have consented to any reasonable use, transfer and disclosure of all messages and data contained or sent via the BioLine’s computer and communications systems, including electronic mail. Consultant shall fully comply with BioLine’s policies regarding computer and network, as may be in effect from time to time.

 

	
6.

	
No Conflicts. Consultant represents and warrants that Consultant’s performance of this Agreement and the Services does not and will not breach or conflict with any agreement to which Consultant is or becomes a party, nor does it require the consent of any other person or entity. Consultant shall inform BioLine, immediately after Consultant becomes aware of it, of any matter or engagement that may in any way raise a conflict of interest between Consultant and BioLine or prevent Consultant from providing the Services.

 

	
7.

	
Independent Contractor. It is understood that Consultant is an independent contractor and not an employee of BioLine. Consultant has no authority to obligate BioLine by contract or otherwise. Consultant will not be considered an employee of BioLine or, other than as expressly provided in this Agreement, eligible for any right or benefit (including such rights and benefits that BioLine may grant to its employees). No deductions shall be made from the Fees nor any transfers made to any governmental or private entity except as set forth in this Agreement, and Consultant hereby waives any claim against BioLine based on such deductions or transfers not being made. If, as a result of a claim or suit by Consultant, a competent court of law rules that the relationship between BioLine and an employee of Consultant is an employer-employee relationship and that, as a result of such relationship, such employee of Consultant is entitled to rights or compensation from BioLine, the following will apply:

 

  

2

  

 

	
  

	
a.

	
the hourly wage of Consultant’s employee as an employee of BioLine will be calculated according to the average monthly salary in Israel (as set forth in the National Insurance Law), assuming that a month consists of 186 hours; and

 

	
  

	
b.

	
Consultant shall fully indemnify BioLine for any damages, liabilities or other costs and expenses incurred in connection with any such determination, and BioLine shall be entitled to offset any amount due to Consultant resulting from the determination that an employer-employee relationship exists against any amount actually paid or due under this Agreement.

 

	
8.

	
Termination.

 

	
  

	
8.1.

	
Either party may terminate this Agreement upon 30 days’ written notice (the “Notice Period”); provided, however, that Sections 4 and 7 will survive the termination or expiration of this Agreement for any reason.

 

	
  

	
8.2.

	
In the event of a termination for Cause (as defined below), BioLine may immediately terminate this Agreement effective as of the time of notice of the same, and without payment in lieu of prior notice. “Cause” means (i) a serious breach of trust including but not limited to theft, embezzlement, self-dealing, prohibited disclosure to unauthorized persons or entities of confidential or proprietary information of or relating to BioLine or its affiliates, and the engaging by Consultant in any prohibited business competitive to the business of BioLine; (ii) any willful failure to perform or failure to perform competently any of Consultant’s fundamental functions or duties hereunder, which was not cured within thirty (30) days after receipt by Consultant of written notice thereof; or (iii) any fundamental breach of this Agreement by Consultant.

 

	
  

	
8.3.

	
During the Notice Period, this Agreement shall remain in full force and effect and there shall be no change in Consultant’s position with BioLine, the Fees or in any other obligations of either party hereunder, unless otherwise determined by BioLine in a written notice to Consultant, and Consultant shall cooperate with BioLine and assist BioLine with the integration into BioLine of the person who will assume Consultant’s responsibilities. At the option of BioLine, Consultant shall during such period either continue with Consultant’s duties or remain absent from BioLine’s premises.

 

	
  

	
8.4.

	
In any event of the termination of this Agreement, Consultant shall immediately return all company property, equipment, materials and documents, as well as all other documents and other materials of any nature pertaining to the Services. Under no circumstances will the Consultant have a lien over any property provided by or belonging to BioLine.

 

	
  

	
8.5.

	
Without derogating from all of BioLine’s rights according to the provisions of this Agreement and the law, both during the term of this Agreement and upon its termination, BioLine shall have the right to deduct from any payment to be paid to the Consultant any sum owed by Consultant to BioLine.

 

	
9.

	
Code of Business Conduct and Ethics; Internal Policies. Consultant shall at all times comply with the Code of Business Conduct and Ethics attached hereto as Exhibit D (the “Code”), the Policy regarding Securities Trades by Company Personnel attached hereto as Exhibit E (the “Insider Trading Policy”), the Company’s Internal Enforcement Policy attached hereto as Exhibit F, and all other internal policies and procedures of BioLine, as shall be updated from time. Updates to the Code, Insider Trading Policy and Internal Enforcement Policy, and copies of BioLine’s other internal policies and procedures, can be obtained at BioLine’s HR office. Consultant represents that he has read the Code and the policies attached as Exhibit E and F, will acquaint himself with BioLine’s other internal policies and procedures and agrees to comply with their terms, including any amendments and updates thereto.

 

  

3

  

	
10.

	
Miscellaneous.

 

	
10.1.

	
Vacation. During the term of this Agreement, Consultant shall be entitled to vacation in the number of working days per year as set forth in Exhibit A, as adjusted in accordance with applicable law.  A “working day” shall mean Sunday to Thursday inclusive, and the use of said vacation days will be coordinated with BioLine. Consultant shall be entitled to accumulation and redemption of vacation days in accordance with BioLine’s policy, which may be amended from time to time in BioLine’s sole discretion.

 

	
10.2.

	
This Agreement constitutes the entire agreement and understanding between the parties with respect to the subject matter hereof, and supersedes all prior written or oral agreements with respect thereto. This Agreement may be assigned by BioLine. Consultant may not assign rights or delegate duties under this Agreement without the prior written consent of BioLine. The provisions of this Agreement will survive the assignment of this Agreement by BioLine to any successor or other assignee. This Agreement may not be modified except by written instrument signed by a duly authorized representative of each party hereto. No failure, delay of forbearance of either party in exercising any power or right hereunder will in any way restrict or diminish such party’s rights and powers under this Agreement, or operate as a waiver of any breach or nonperformance by either party of any terms of conditions hereof. If it is determined under any applicable law that a certain provision set forth in this Agreement is invalid or unenforceable, such determination will not affect the remaining provisions of this Agreement. This Agreement will be governed by the laws of the State of Israel. Any dispute arising out of or in connection with this Agreement will be subject to the exclusive jurisdiction of the competent courts in Jerusalem, Israel.

 

	
11.

	
Counterparts. For the convenience of the parties, this Agreement may be signed in counterparts, each of which will be an original instrument and all of which taken together will constitute one and the same Agreement. Delivery of a signed counterpart of this Agreement by e-mail or facsimile transmission will constitute valid and sufficient delivery thereof.

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.

 

	
BioLineRx Ltd.

 

By: /s/ Kinneret Savitsky                                           

 

Name: Kinneret Livnat Savitsky

 

Title: CEO

	
Arnon Aharon, M.D.

 

/s/ Arnon Aharon                                

 

 

  

4

  

Exhibit A

Description of the Services

and Other Matters

 

	
1.

	
Consultant will provide services as Vice President of Medical Affairs, under the direct supervision and in compliance with the directives of the Chief Executive Officer and/or any individual designated by BioLine at its sole discretion. Consultant’s Services may also include other services performed for affiliates of BioLine.

 

	
2. 

	
Consultant will provide Services as follows:

 

	 	
a. 

	
during January 2014, three full days per week at BioLine’s offices in Jerusalem.

 

	 	
b.

	
beginning February 1, 2014, on a full time basis of no less than 43 hours per week, five full days per week, Sunday through Thursday.

 

A “full day” means a work day of no less than 8.6 hours. Consultant may also work outside of regular working hours and outside of regular working days, as may be required by BioLine from time to time.

 

	
3.

	
Beginning February 1, 2014, Consultant shall not undertake or accept any other paid or unpaid employment or occupation or engage in any other business activity except with the prior written consent of BioLine, which shall not be unreasonably withheld.

 

	
4.

	
Consultant shall provide Services primarily at BioLine’s facilities in Jerusalem. In addition, Consultant shall provide Services at such other places as are appropriate to the functions being performed by BioLine. Consultant acknowledges and agrees that his position may involve significant domestic and international travel.

	
5. 

	
Options to be granted in accordance with Section 3: 300,000

	
6. 

	
Vacation days: 21 per year

  

5

  

 

Exhibit B

Proprietary Information, Confidentiality and Non-Competition Agreement

	
1.

	
General.

 

	
  

	
1.1.

	
All capitalized terms herein shall have the meanings ascribed to them in the Consulting Agreement to which this Exhibit B is attached (the “Consulting Agreement”). For purposes of any undertaking of Consultant toward BioLine, the term BioLine shall include all subsidiaries and affiliates of BioLine.

 

	
  

	
1.2.

	
Consultant’s obligations and representations and BioLine’s rights under this Exhibit B (this “Agreement”) shall apply as of the Effective Date of the Consulting Agreement.

 

	
  

	
1.3.

	
Consultant’s undertakings hereunder shall remain in full force and effect after termination of this Agreement or the Consulting Agreement, or any renewal thereof.

 

	
2.

	
Consultant acknowledges that he/she has received and/or may receive information of a confidential and proprietary nature regarding the activities and business of BioLine, its parent companies, subsidiaries and/or affiliates, all whether in oral, written, graphic, or machine-readable form, or in any other form, including, but not limited to, (i) patents and patent applications and related information, (ii) trade secrets and industrial secrets, and (iii) drugs, compounds, molecules, building blocks, chemical libraries, reaction protocols for chemical libraries, chemical structures, chemical design and model relationship data, chemical databases, assays, samples, media and other biological materials, procedures and formulations for producing any such materials, products, processes, ideas, know-how, trade secrets, drawings, inventions, improvements, formulas, equations, methods, developmental or experimental work, research or clinical data, discoveries, developments, designs, techniques, instruments, devices, computer software and hardware related to the current, future and/or proposed products and services, and including, without limitation, information regarding research, development, new service offerings or products, marketing and selling, business plans, forecasts, business methods, budgets, finances, licensing, collaboration and development arrangements, prices and costs, buying habits and practices, contact and mailing lists and databases, vendors, customers and clients, and potential business opportunities, and personnel (collectively, “Confidential Information”). Confidential Information may also include information furnished to BioLine by third parties, which, for purposes of this Agreement, shall all be deemed Confidential Information of BioLine. Notwithstanding the aforesaid, information that is in the public domain, through no act or omission of Consultant shall not be deemed Confidential Information. The Confidential Information and all right, title and interest therein will remain at all times the exclusive property of BioLine (or any third party entrusting its own Confidential Information to BioLine).

 

	
3.

	
At all times during the term of the Consulting Agreement and thereafter, Consultant will hold all Confidential Information in strictest confidence and will not disclose, use, or make any copies thereof. Consultant hereby assigns to BioLine any rights that Consultant may have or acquire in such Confidential Information and recognize that all Confidential Information shall be the sole property of BioLine and its assigns or licensors, as applicable.

 

	
4.

	
Consultant will promptly disclose and describe to BioLine all inventions, improvements, designs, concepts, techniques, methods, processes, know how, and trade secrets, whether or not patentable, copyrightable or protectable as trade secrets that are made, developed, conceived or first reduced to practice or created by Consultant, whether alone or jointly with others, during Consultant’s engagement with BioLine (i) which relate to BioLine’s business or actual or demonstrably anticipated research or development, (ii) which are developed in whole or in part on BioLine’s time or with the use of any of BioLine’s Confidential Information or other information, equipment, supplies, facilities or trade secret information, or (iii) which result directly or indirectly from any work performed by Consultant for BioLine (the “Inventions,” and each an “Invention”).

 

  

6

  

 

	
5.

	
Consultant hereby assigns and agrees to assign in the future (when any such Inventions or Proprietary Rights (defined below) are first reduced to practice or first fixed in a tangible medium, as applicable) to BioLine or its designee(s) all of Consultant’s right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes. Consultant further specifically assigns to BioLine all original works of authorship, including any related moral rights, which are made by Consultant (solely or jointly with others) during the term of the Consulting Agreement which are protectable by copyright pursuant to applicable copyright law. Consultant also agrees to assign all of his right, title and interest in and to any particular Invention to any third party, including without limitation government agency, as directed by BioLine. Consultant hereby waives and irrevocably quitclaims to BioLine any and all claims, of any nature whatsoever, that Consultant now has or may hereafter have for infringement of any and all rights in Inventions and Proprietary Rights. To the extent any moral rights cannot be assigned under applicable law and to the extent the following is allowed by the laws in the various countries where moral rights exist, Consultant hereby waives such moral rights and consent to any action of BioLine that would violate such moral rights in the absence of such consent.

 

The term “Proprietary Rights” shall mean: (i) patents, whether in the form of utility patents or design patents and all pending applications for such patents; (ii) trademarks, trade names, service marks, designs, logos, trade dress, and trade styles, whether or not registered, and all pending applications for registration of the same; (iii) copyrights or copyrightable material, including moral rights, including but not limited to books, articles and publications, whether or not registered, and all pending applications for registration of the same; and (iv) all other intellectual property rights throughout the world.

 

	
6.

	
Consultant specifically acknowledges and agrees that Consultant’s duties with BioLine may entail the invention and development of new ideas, technologies, products and other confidential and proprietary information, and that the creation of any such intellectual property is an inherent part of Consultant’s duties with BioLine. Consultant expressly agrees that the consideration paid to Consultant pursuant to his Consulting Agreement constitutes the sole consideration to which Consultant may be entitled to for the assignment of any and all Inventions or Proprietary Rights made, developed, conceived or first reduced to practice or created by Consultant (or with his assistance or contribution) including, without limitation, in accordance with Section 134 of the Patent Law, 5727-1967 (the “Patent Law”), and Consultant shall not be entitled to receive any additional consideration in this respect whatsoever. Without derogating from the aforesaid, it is hereby clarified that the level of Consultant’s compensation and consideration has been established based upon the aforementioned waiver of rights to receive any such additional royalties, consideration or other payments. The above will apply to any “Service Inventions” as defined in the Patent Law. It being clarified that under no circumstances will Consultant be deemed to have any Proprietary Right in any Service Invention, notwithstanding the provision or non-provision of any notice of an invention and/or BioLine’s response to any such notice, under Section 132(b) of the Patent Law. This Agreement is expressly intended to be an agreement with regard to the terms and conditions of consideration for Service Inventions in accordance with Section 134 of the Patent Law.

 

	
7.

	
Consultant will assist BioLine in every proper way to obtain, and from time to time enforce, any Proprietary Rights relating to any Inventions in any and all countries.  To that end Consultant will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as BioLine may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof.  In addition, Consultant will execute, verify and deliver assignments of such Proprietary Rights to BioLine or its designee.  Consultant’s obligation to assist BioLine with respect to Proprietary Rights relating to any such Inventions in any and all countries shall continue indefinitely beyond termination of the Consulting Agreement for any reason (the “Termination Date”), but BioLine shall compensate Consultant at a reasonable rate after the Termination Date for the time actually spent by Consultant at BioLine’s request on such assistance.

 

  

7

  

 

	
8.

	
If BioLine is unable for any reason, after reasonable effort, to secure Consultant’s signature on any document needed in connection with the actions specified in the preceding paragraph, Consultant hereby irrevocably designates and appoints BioLine and its duly authorized officers and agents as Consultant’s agent and attorney in fact, which appointment is coupled with an interest, to act for and in Consultant’s behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by Consultant. Consultant hereby waives and holds BioLine harmless from any and all claims, of any nature whatsoever, which Consultant now or may hereafter have for infringement of any Proprietary Rights assigned hereunder to BioLine.

 

	
9.

	
Consultant agrees to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by BioLine) of all Confidential Information developed by Consultant and all Inventions made by Consultant during the term of the Consulting Agreement to BioLine, which records shall be available to and remain the sole property of BioLine at all times.

 

	
10.

	
During the term of the Consulting Agreement, Consultant will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom Consultant has an obligation of confidentiality, and Consultant will not bring onto the premises of BioLine any unpublished documents or any property belonging to any former employer or any other person to whom Consultant has an obligation of confidentiality unless consented to in writing by that former employer or person.

 

	
11.

	
Upon the earlier of (i) a written request by BioLine; or (ii) the expiration or termination of the engagement, Consultant shall promptly return to BioLine all Confidential Information, together with any and all copies or excerpts thereof and any and all other information directly or indirectly derived therefrom. Return or destruction of the Confidential Information as required hereunder shall not affect Consultant’s remaining obligations pursuant to this Agreement.

 

	
12.

	
Non-Competition; Non Solicitation.

 

	
  

	
12.1.

	
In consideration of Consultant’s terms of engagement, which include special compensation for Consultant’s undertakings under this Section 12, and in order to enable BioLine to effectively protect its Proprietary Information, Consultant undertakes that during the term of the Consulting Agreement and for a period of twelve (12) months from the Termination Date, Consultant will not directly or indirectly: (i) carry on or hold an interest in any company, venture, entity or other business (including, without limitation, as a shareholder other than a minority interest in a publicly traded company) which directly competes with the products or services of BioLine (a “Competing Business”) ; (ii) act as a consultant, Consultant or officer or in any managerial capacity in a Competing Business, or supply in direct competition with BioLine services to any person who, to Consultant’ s knowledge, was provided with services by BioLine any time during the twelve (12) months immediately prior to the Termination Date; (iii) solicit, canvass or approach or endeavor to solicit, canvass or approach any person who, to Consultant’s knowledge, was provided with services by BioLine at any time during the twelve (12) months immediately prior to the Termination Date, for the purpose of offering services or products which directly compete with the services or products supplied by BioLine at the Termination Date; or (iv) employ, solicit or entice away or endeavor to solicit or entice away from BioLine any person employed by BioLine any time during the twelve (12) months immediately prior the Termination Date with a view to inducing that person to leave such employment and to act for another employer in the same or a similar capacity.

 

	
  

	
12.2.

	
Insofar as the protective covenants set forth in this Agreement are concerned, Consultant specifically acknowledges, stipulates and agrees as follows: (i) the protective covenants are reasonable and necessary to protect the goodwill, property and Proprietary Information of BioLine, and the operations and business of BioLine; and (ii) the time duration of the protective covenants is reasonable and necessary to protect the goodwill and the operations and business of BioLine, and does not impose a greater restraint than is necessary to protect the goodwill or other business interests of BioLine. Nevertheless, if any of the restrictions set forth in this Agreement is found by a court having jurisdiction to be unreasonable or overly-broad as to geographic area, scope or time or to be otherwise unenforceable, the parties intend for the restrictions set forth in this Agreement to be reformed, modified and redefined by such court so as to be reasonable and enforceable and, as so modified by such court, to be fully enforced.

 

  

8

  

 

	
13.

	
Consultant represents that Consultant’s performance of all the terms of the Consulting Agreement and this Agreement does not and will not breach any agreement to keep in confidence information acquired by Consultant in confidence or in trust prior to Consultant’s relationship with BioLine. Consultant has not entered into, and agrees that he/she will not enter into, any agreement either written or oral in conflict herewith.

 

	
14.

	
Consultant hereby agrees that if the Consulting Agreement is terminated, Consultant shall notify any new employer or client of Consultant ’s rights and obligations under this Agreement.

 

	
15.

	
Consultant acknowledges that any violation or threatened violation of this Agreement may cause irreparable injury to BioLine, entitling BioLine to seek injunctive relief in addition to all other legal remedies.

 

	
16.

	
Consultant recognizes and agrees that: (i) this Agreement is necessary and essential to protect the business of BioLine and to realize and derive all the benefits, rights and expectations of conducting BioLine’s business; (ii) the area and duration of the protective covenants contained herein are in all things reasonable; and (iii) good and valuable consideration exists under the Consulting Agreement, for Consultant’s agreement to be bound by the provisions of this Agreement.

 

	
17.

	
The terms of Section 10.2 of the Consulting Agreement shall apply to this Agreement.

 

	
18.

	
CONSULTANT ACKNOWLEDGES THAT HE/SHE HAS READ THIS AGREEMENT CAREFULLY, UNDERSTANDS ITS TERMS AND HAS BEEN GIVEN THE OPPORTUNITY TO DISCUSS IT WITH INDEPENDENT LEGAL COUNSEL.

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date of the Consulting Agreement.

 

	
BioLineRx Ltd.

 

By: /s/ Kinneret Savitsky                                           

 

Name: Kinneret Livnat Savitsky

 

Title: CEO

	
Arnon Aharon, M.D.

 

/s/ Arnon Aharon                                

 

 

 

  

9

  

 

Exhibit C

[intentionally omitted]

  

10

  

Exhibit D

BioLineRx Ltd. Code of Business Conduct and Ethics

Effective as of January 1, 2011

 

POLICY STATEMENT

 

It is the policy of BioLineRx Ltd. (the “Company”) to conduct its affairs in accordance with all applicable laws, rules and regulations of the jurisdictions in which it does business. This Code of Business Conduct and Ethics (this “Code”) applies to the Company’s employees, officers and directors. This Code is designed to promote:

 

	
·

	
honest and ethical conduct by all of the Company’s employees, officers and directors, including the ethical handling by such persons of actual or apparent conflicts of interest between personal and professional relationships;

 

	
·

	
full, fair, accurate, timely and understandable disclosure in the reports and documents the Company files with, or submits to, the U.S. Securities and Exchange Commission (“SEC”) or the Israeli Securities Authority (“ISA”), and in other public communications made by the Company;

 

	
·

	
compliance with applicable governmental laws, rules and regulations;

 

	
·

	
the prompt internal reporting to the appropriate person of violations of this Code; and

 

	
·

	
Accountability for adherence to this Code.

 

All directors, officers and employees of the Company are subject to this Code and are expected to adhere to and comply with those principles and procedures set forth in this Code that apply to them. The Company will take such disciplinary or preventative action as it deems appropriate to address any existing or potential violation of this Code brought to its attention.

 

APPROVALS AND WAIVERS

 

Certain provisions of this Code require you to act, or to refrain from acting, unless prior approval is received from the appropriate person. Employees requesting approval pursuant to this Code should request such approval in writing from the Compliance Officer. Approvals relating to Executive Officers and Directors must be obtained from the Company’s Board of Directors. All other approvals may be granted by the Compliance Officer, or such officer’s designee.

 

Other provisions of this Code require you to act, or to refrain from acting, in a particular manner and do not permit exceptions based on obtaining an approval. Waiver of those provisions relating to Executive Officers, senior financial officers and Directors may only be granted by the Board of Directors.

 

  

11

  

 

 

RESPONSIBILITY FOR COMPLIANCE

 

Your responsibility

 

You are obligated to adhere to this policy in the performance of your job responsibilities. When faced with a situation that requires an evaluation of what is, and what is not, proper business conduct, begin by applying the following criteria:

 

	
• 

	
Is the course of conduct legal?

 

	
•

	
Is the course of conduct in accordance with the guidelines set forth in this Code and with Company policies and procedures?

 

	
•

	
Would you or the Company be compromised or embarrassed if the situation were known by your co-workers or the public?

 

	
• 

	
Does the intended course of conduct have the appearance of impropriety?

 

If you are unable to answer “yes” to the first two questions and “no” to the second two questions with certainty, seek advice through the channels described under the section entitled “To seek advice or report non-compliance.”

 

Remember that failure to report a violation of this Code is itself a violation.

 

To seek advice or report non-compliance

 

If you suspect non-compliance, or have a question as to any aspect of this Code, including its interpretation, application or compliance therewith, regarding yourself or any other employee of BioLineRx, you must seek the advice of the appropriate Company authority, such as your immediate supervisor, human resources manager or General Counsel. If for any reason you feel uncomfortable discussing your concerns or questions with these individuals, or if you are dissatisfied with their responses, seek advice from the Internal Auditor. If you prefer, you may correspond anonymously with the Internal Auditor through our confidential mailbox: biolinerx@deloitte.co.il.

 

The Company Compliance Team:

 

	
Nurit Benjamini

Audit Committee Chairperson

email: nurit378@gmail.com

Tel: 052-644-0745

	
Linur Dloomy, CPA (Deloitte)

Internal Auditor

e-mail: LDloomy@deloitte.co.il

Tel: 052-583-9635

Disciplinary action

 

The Company intends to prevent the occurrence of conduct not in compliance with the Code, applicable laws or regulations, or other policies, procedures and guidelines prepared by our Company and its business units and to halt any such conduct that may occur as soon as reasonably possible after its discovery. Allegations of non-compliance with the Code will be investigated whenever necessary and evaluated at the proper level(s). Those found to be in violation of this Code are subject to appropriate disciplinary action, up to and including termination of employment. Criminal misconduct may be referred to the appropriate legal authorities for prosecution.

 

  

12

  

 

When in doubt . . .

 

If you think you are being asked to behave or conduct business in an illegal, unethical or otherwise inappropriate manner, or you suspect others of such behavior, immediately report your concerns through the channels described above. You will not be penalized for reporting what you believe, in good faith, to be a breach of the Code; even if it later turns out that a violation has not occurred.

 

THE EMPLOYMENT RELATIONSHIP

 

Terms of employment

 

BioLineRx employees are generally employed by the Company either pursuant to an employment contract or other arrangement. Subject to applicable law, both the employee and the employer are legally allowed to terminate the employment at will. This BioLineRx Code may be revised from time to time at the Company’s discretion and is not a contract of employment.

 

Anti-discrimination and anti-harassment

 

BioLineRx hires, pays, promotes and makes other employment decisions based upon lawful factors, such as qualifications and performance, and without regard to race, sex, color, religion, age, national origin, sexual orientation, disability or any other basis that is protected under applicable law.

 

Drug and alcohol abuse and drug-free workplace

 

BioLineRx prohibits the illegal use, sale, purchase, transfer, possession or presence in one’s system of drugs, other than medically prescribed drugs, while on the Company’s premises.

 

Workplace violence

 

BioLineRx does not tolerate workplace violence or threats of violence committed by or against employees or property.

 

Conflict of interest and opportunities for personal gain

 

All Directors, officers and employees must avoid relationships, activities or interests that conflict or appear to conflict with the interests of the Company. Directors, officers and all employees have an obligation to promptly disclose to their supervisor or local internal auditor any relationship, activity or interest that could possibly involve or appear to involve an actual or potential conflict of interest. If you are unsure whether something is a conflict of interest you are obligated to promptly disclose it to your supervisor.

 

  

13

  

 

Related Party Transactions

 

All Directors, officers and employees should immediately inform a representative of the Finance Department or General Counsel at the outset of negotiations or contacts regarding a potential transaction between an entity or a person related to a Director, officer or employee of BioLineRx or its subsidiaries and BioLineRx or its subsidiaries and in any event prior to completion of any such transaction (without regard to size or materiality).

 

Acceptance and giving entertainment or gifts

 

You may never accept bribes, kickbacks, or other types of unusual payments from any organization or individual seeking to do business with, doing business with, or competing with BioLineRx. You may accept gifts or entertainment of nominal value as part of the normal business process if public knowledge of your acceptance would cause the Company no conceivable embarrassment. In accordance with foreign laws, you are prohibited from directly or indirectly authorizing, offering, promising or giving anything of value to a foreign governmental official as a means of influencing or inducing the official to obtain or retain business for BioLineRx.

 

Fraud

 

You may not engage in fraudulent conduct. “Fraud” is the deliberate practice of deception in order to receive unfair or unlawful gain.

 

Financial reporting

 

All financial and other records of the Company are required to accurately and fairly reflect the Company’s assets, liabilities, revenues and expenses.

 

Outside employment or consulting

 

Employment as a consultant, officer, or manager of another business organization requires prior written management approval. Outside employment or consulting must never interfere with your job performance, utilize Company property or facilities, involve the implicit or explicit sponsorship of the Company, or create the possibility of adverse publicity for the Company.

 

Political activity and contributions

 

Requiring anyone at BioLineRx to make a personal or corporate contribution to any candidate, political party, or holder of any governmental office is prohibited. You are free to participate in lawful political activity.

 

Company records and accounts

 

All Company records and accounts are the property of BioLineRx. Company records and accounts must be maintained at all times in reasonable detail and in a manner that accurately reflects all business and financial transactions, including the disposition of assets. The destruction or falsification of a document in order to impede a litigation, governmental investigation, audit or examination is prohibited and may lead to prosecution for obstruction of justice.

 

  

14

  

 

Protection of the Company’s Property

 

All employees should endeavor to protect the Company’s property, plant and other tangible and intangible assets. Company property should not be used for non-Company business, though incidental personal use may be permitted.

 

Expense accounts

 

The Company recognizes its responsibility to reimburse you for legitimate business expenses. Those expenses should be within reasonable limits and commensurate with the nature of the business assignment. You are expected to fully and clearly document business expenses and comply with the travel policy, which applies to your business unit/locale.

 

Employee privacy

 

Company information about employees is confidential and only those with a legitimate, work-related need may access such information. BioLineRx will not release any information about you to entities outside the Company without your written authorization or unless required to do so by applicable law, pursuant to a summons, subpoena or court order, or as deemed appropriate by the Company.

 

Proprietary information and intellectual property

 

Proprietary business, technical, personal information or any trade secret of the Company and its employees, customers and suppliers is considered confidential and must be safeguarded. Intellectual property developed by you or by others for the Company, or for which the Company has secured rights from others, should be used only for the benefit of the Company. Accordingly, all intellectual property rights derived from confidential information or other materials made, originated or developed by the employees shall belong exclusively to the Company, and the employees who are the inventors or developers of such intellectual property rights shall have no rights or benefits therein or deriving therefrom. You may not disclose proprietary information of the Company, its employees, customers, former employees, former customers or suppliers. These prohibitions continue even if you cease being employed by the Company for any reason.

 

Corporate data security

 

Corporate data refers to all information collected, created, processed and/or maintained in the normal course of BioLineRx’s business. The data may be in manual form (examples include verbal, handwritten, typed onto hard copy, microfilmed, photocopied or computer printouts), electronic form (examples include e-mails, voice-mails, computer memory, magnetic tape, cassette, disk, or diskette), or BioLineRx ­specific information included in computer applications programs, personal computing software, or operating system software.

 

All BioLineRx employees and any other person having physical or electronic access to corporate data are responsible for safeguarding corporate data by knowing and keeping such corporate data confidential.

 

  

15

  

 

Electronic communications

 

You may not access or use BioLineRx’s electronic and wire communications systems without appropriate authority. No individual shall use the passwords or codes of another individual in order to gain access to that individual’s e-mail, voice mail, or Internet communications on BioLineRx’s systems unless first authorized to do so by that individual or the Company. These systems are provided for Company business, and only occasional personal use of the systems is permissible. Occasional personal use means minimal and infrequent use that does not interfere with BioLineRx business or job performance. BioLineRx’s systems may not be used to access or transmit material that could embarrass, harass, or offend other persons.

 

External communications

 

Requests for financial or business information, for interviews with any BioLineRx employee including comments or responding to requests relating to BioLineRx or its business, or the issuance of any press releases by any BioLineRx employee must be referred to the Company’s Chief Financial Officer.

 

Public disclosure requirements

 

All reports and submissions (“Reports”) of BioLineRx to the SEC, NASDAQ, the Israel Securities Authority and the Tel Aviv Stock Exchange must comply with applicable legal and exchange requirements and may not contain material misstatements or omit material facts.

 

RELATIONSHIPS WITH BUSINESS ENTITIES AND AUTHORITIES

 

Product quality

 

We are committed to making safe quality products for our sublicensees and future users of our products. We expect each BioLineRx employees to contribute to these standards by providing high quality work, being fully familiar with applicable laws and regulations that are pertinent to their areas of responsibility and participating in training programs provided by the Company covering broad ranges of activities. Employees are also encouraged to exert diligence in identifying and preventing practices that could impair product quality, safety or compliance with law.

 

Economic Sanctions

 

BioLineRx employees must comply with the applicable laws and regulations relating to economic and trade sanctions and embargoes against certain countries or entities. This includes refraining from indirect facilitation of a prohibited transaction.

 

  

16

  

Foreign corrupt practices and anti-boycott laws

 

In accordance with local and/or foreign laws, BioLineRx employees are prohibited from directly or indirectly authorizing, offering, promising or giving anything of value to a foreign governmental official as a means of influencing or inducing the official to obtain or retain business for BioLineRx. BioLineRx employees also are required to comply with applicable corrupt practices laws and anti-boycott laws that prohibit participation in certain foreign boycotts.

 

Securities laws compliance/insider trading

 

All BioLineRx employees must strictly obey all laws that prohibit the trading of securities based on prior knowledge of “material,” “non-public” information about BioLineRx. You may not trade BioLineRx stock, nor recommend to others that they trade BioLineRx stock, until such information has been publicly disclosed. These restrictions also apply to any trading, including securities of other companies, based on material, non-public information about customers, competitors or business partners of BioLineRx, either when trading BioLineRx securities or the securities of these other companies as well.

 

Unfair trade practices and fair dealing

 

All BioLineRx employees must comply with applicable laws in their place of employment and the laws of other applicable jurisdictions that prohibit unfair or deceptive business acts and practices, as well as unfair competition

 

Environmental protection

 

As a Company we are committed to full compliance with all applicable environmental protection laws and expect your individual cooperation

 

Health and safety

 

Employees must observe safe practices on their jobs, report any injury or accident at work promptly and follow Company security and emergency policies and procedures.

 

  

17

  

Exhibit E

 

BioLineRx Ltd.

 

STATEMENT OF COMPANY POLICY

 

SECURITIES TRADES BY BIOLINERX LTD. PERSONNEL

 

BioLineRx Ltd. (the “Company”) has adopted the following Policy regarding trading by Company personnel in the Company’s securities.  The Policy applies to all Company personnel, including directors, officers, employees and consultants of the Company and its subsidiaries.

 

The Need for a Policy

 

This Policy has been developed:

 

	
  

	
·

	
to educate all Company personnel;

 

	
  

	
·

	
to set forth guidelines for courses of action;

 

	
  

	
·

	
to protect the Company and all of its personnel against legal liability; and

 

	
  

	
·

	
to preserve the reputation of the Company and its personnel for integrity and ethical conduct.

 

Since the Company is a public company with its ordinary shares traded on the Tel Aviv Stock Exchange and its American Depositary Shares on the Nasdaq Capital Market, transactions in the Company’s securities are subject to both Israeli and United States federal securities laws and regulations.  These laws and regulations make it illegal for an individual to buy or sell securities of the Company while aware of “inside information.”  The U.S. Securities and Exchange Commission (SEC) and the Israel Securities Authority (ISA) take insider trading very seriously and devote significant resources to uncovering the activity and to prosecuting offenders.  Liability may extend not only to the individuals who trade on “inside information,” but also to their “tippers,” people who leak the inside information to the individuals who trade.  The Company and “controlling persons” of the Company may also be liable for violations by Company employees.

 

In addition to responding to the statutes and regulations, we are adopting this Policy to avoid even the appearance of improper conduct on the part of anyone employed by or associated with the Company (not just “insiders”).

 

The Consequences

 

The consequences of insider trading violations can be severe. The following are examples under U.S. law applicable to the Company:

 

For individuals who trade on inside information (or tip information to others):

 

	
  

	
·

	
a civil penalty of up to three times the profit gained or loss avoided;

 

	
  

	
·

	
a criminal fine (no matter how small the profit) of up to $5 million; and

 

	
  

	
·

	
a jail term of up to twenty years.

 

  

18

  

 

 

For a company (as well as possibly any supervisory person) that fails to take appropriate steps to prevent illegal trading:

 

	
  

	
·

	
a civil penalty of the greater of $1 million or three times the profit gained or loss avoided as a result of the employee’s violation; and

 

	
  

	
·

	
a criminal penalty of up to $25 million.

 

Any of the above consequences – or even an SEC or ISA investigation that does not result in prosecution – can tarnish one’s reputation and irreparably damage a career. In addition, if an employee violates this Policy, Company-imposed sanctions, including dismissal for cause, could result from failing to comply with the Company’s policy or procedures.

 

Our Policy

 

It is the Company’s policy that no Company personnel nor any related persons may buy or sell securities of the Company while aware of material nonpublic information or engage in any other action to take advantage of, or pass on to others, that information.

 

This Policy also applies with equal force to information relating to any other company, including our collaborators, partners, suppliers, customers and others, obtained by Company personnel during the course of his or her service to or employment by the Company.

 

Transactions that may be necessary or justifiable for independent reasons (such as the need to raise money for an emergency expenditure) are no exception.  Even the appearance of an improper transaction must be avoided to preserve our reputation for adhering to the highest standards of conduct.

 

Policy Administrator.  This Policy shall be administered by the “Policy Administrator,” who shall initially be the Chief Financial and Operating Officer.  The Policy Administrator may, however, change from time to time, and you are encouraged to consult the copy of this Policy that is included on the Company’s website to obtain current information concerning the Policy Administrator.

 

Material Non-Public Information.  Material non-public information (i.e., “inside information”) is any information that:

 

	
  

	
·

	
is not generally known to the public, and

 

	
  

	
·

	
which, if publicly known, would likely affect either the market price of the Company’s securities or a person’s decision to buy, sell or hold the Company’s securities.

 

Information “generally known to the public” is information released to the press or the industry and after public investors and the market have had a reasonable period of time to evaluate and react to the information. All other information is regarded as non-public.

 

Examples of Material Information.  Common examples of information that will frequently be regarded as material are:

 

	
  

	
·

	
quarterly or annual earnings results;

 

	
  

	
·

	
projections of future results or sales;

 

	
  

	
·

	
earnings or losses;

 

	
  

	
·

	
news of a pending or proposed merger, acquisition or tender offer;

 

	
  

	
·

	
an important financing transaction;

 

  

19

  

 

	
  

	
·

	
significant clinical or regulatory developments;

 

	
  

	
·

	
the entry into or termination of a significant collaboration, joint venture or strategic alliance;

 

	
  

	
·

	
changes in management;

 

	
  

	
·

	
significant new products or discoveries;

 

	
  

	
·

	
plans regarding strategy or significant capital investments;

 

	
  

	
·

	
impending bankruptcy or financial liquidity problems;

 

	
  

	
·

	
criminal charge or government investigations;

 

	
  

	
·

	
internal financial information which departs from what the market would expect; and

 

	
  

	
·

	
the gain or loss of any significant contract or agreement.

 

Either positive or negative information may be material.  We emphasize that this list is merely illustrative.

 

Twenty-Twenty Hindsight.  Remember, if your securities transactions become the subject of scrutiny, they will be viewed after-the-fact with the benefit of hindsight.  As a result, before engaging in any transaction, you should carefully consider how regulators and others might view your transaction in hindsight.

 

Transactions by Family Members and Others in Your Household.  These restrictions also apply to your “immediate family members” – that is, a spouse, parent, child or sibling and any other family member who shares the same address as, or is financially dependent on you.  Employees are expected to be responsible for the compliance of all family members with this Policy.  Employees are also expected to be responsible for the compliance of other persons who live in their household, whether or not related, with this Policy.

 

Tipping Information to Others.  Whether the information is proprietary information about the Company or information that could have an impact on our stock price, Company personnel must not pass the information on to others.  The above penalties apply, whether or not you derive any monetary benefit from another person’s actions.  Inside information is often inadvertently disclosed or overheard in casual, social conversations.  Care must be taken to avoid such disclosures.

 

When Information is Public.  As you can appreciate, it is also improper for Company personnel to trade the Company’s securities immediately after the Company has made a public announcement of material information.  Since the Company’s shareholders and the investing public should be afforded time to receive information and to act upon it, as a general rule you should not engage in any transactions until the beginning of the second business day after the information has been released.  Thus, if an announcement is made on a Monday, Wednesday generally would be the first day on which you should trade.  If an announcement is made on a Friday, Tuesday generally would be the first day on which you should trade.  However, if the information released is complex, such as a prospective major financing or other transaction, it may be necessary to allow additional time for the information to be absorbed by investors.  In such circumstances, you will be notified by the Policy Administrator regarding a suitable waiting period before trading.

 

Prevention of Insider Trading by Others.  If you become aware of a potential insider trading violation, you must immediately advise the Policy Administrator.  You should also take steps, where appropriate, to prevent persons under your supervision or control from using inside information for trading purposes.

 

  

20

  

 

Confidentiality.  Serious problems could be caused for the Company by the unauthorized disclosure of internal information about the Company, whether or not for the purpose of facilitating improper trading in the securities of the Company.  Company employees should not discuss internal company matters or developments with anyone outside of the Company, except as required in the performance of regular corporate duties.

 

This prohibition applies specifically (but not exclusively) to inquiries about the Company that may be made by the financial press, investment analysts or others in the financial community.  It is important that all such communications on behalf of the Company be through an appropriately designated officer under carefully controlled circumstances.  Unless you are expressly authorized to the contrary, if you receive any inquiries of this nature, you should decline comment and refer the inquirer to the Chief Financial and Operating Officer.

 

Nothing in this Policy is meant to limit or change the obligations of confidentiality and non-use of non-public information that directors, officers, employees and consultants of the Company by virtue of their positions or their agreements with the Company. Such obligations also apply in the context of any electronic chat room or electronic bulletin board, including participation under a pseudonym.

 

Additional Prohibited Transactions

 

Since we believe it is generally improper and inappropriate for Company personnel to engage in short-term or speculative transactions involving the Company’s securities, it is our policy that such personnel should not engage in any of the following activities with respect to the Company’s securities:

 

	
  

	
·

	
Trading in the Company’s securities on a short-term basis.  Any ordinary shares of the Company purchased in the open market should be held for a minimum of 60 days.

 

	
  

	
·

	
Short sales of the Company’s securities.

 

	
  

	
·

	
Use of the Company’s securities to secure a margin or other loan, except in limited cases with the prior approval of the Policy Administrator.

 

	
  

	
·

	
Transactions in straddles, collars, or other similar risk reduction devices, except in limited cases with the prior approval of the Policy Administrator.

 

	
  

	
·

	
Transactions in publicly-traded options relating to the Company’s securities (i.e., options that are not granted by the Company), except in limited cases with the prior approval of the Policy Administrator.

 

Trading Blackouts Applicable to all Company Personnel

 

While it is never permissible to trade based on material non-public information, we are implementing procedures to help prevent inadvertent violations and avoid even the appearance of an improper transaction (which could result, for example, where Company personnel engage in a trade while unaware of a pending major development).

 

  

21

  

 

Prohibited Periods for Trading.  No person to whom this Policy is applicable may trade in the Company’s securities during the following periods:

 

	
  

	
·

	
the periods starting on the 15th day after the close of each fiscal quarter and ending at the beginning of the second business day after the release of the Company’s financial results for each quarter and, in the case of the fourth quarter, financial results for the year end; and

 

	
  

	
·

	
any other periods as determined by the Company. You will be notified by e-mail when you may not trade in the Company’s securities during such periods, and you will also be notified when trading restrictions are lifted.

 

There are no restrictions on exercising options without a sale. Selling the shares held as a result of exercising options is subject to the restrictions set forth above.

 

Pre-Clearance of Trades

 

In order to ensure and maintain compliance with this Policy, all transactions in the Company’s securities (acquisitions, dispositions, transfers, etc.), including the execution of Trading Plans (as defined below), by directors, members of Executive Management, financial team members and designated employees must be pre-cleared in advance by the Policy Administrator.  If you are a member of one of the groups listed above and you contemplate a transaction in the Company’s securities, you must contact the Policy Administrator or other designated individual prior to executing the transaction.  The Policy Administrator will use his reasonable best efforts to provide approval or disapproval as soon as practicable.  You must wait until receiving pre-clearance to execute the transaction.  Neither the Company nor the Policy Administrator shall be liable for any delays that may occur due to the pre-clearance process.  If the transaction is pre-cleared by the Policy Administrator, it must be executed by the end of the second business day after receipt of pre-clearance.  Notwithstanding receipt of pre-clearance of a transaction, if you become aware of material nonpublic information after receiving the pre-clearance but prior to the execution of the transaction, you may not execute the transaction.

 

Please note that such pre-clearance does not provide the insider with immunity from investigation or suit; it is the responsibility of the individual to comply with the applicable securities laws and regulations.

 

Exception for Trading Plans

 

Notwithstanding the restrictions and prohibitions on trading in the Company securities as set forth in this Policy, persons subject to this Policy are permitted to effect transactions in Company securities pursuant to approved trading plans established under Rule 10b5-1 under the Securities Exchange Act of 1934 (“Trading Plans”), including transactions during the prohibited periods discussed above.  Rule 10b5-1 requires that these transactions be made pursuant to a plan that was established while the person was not in possession of material non-public information.  In order to comply with this Policy, the Company must pre-approve any such Trading Plan prior to its effectiveness.  Company personnel seeking to establish a Trading Plan should contact the Policy Administrator.

 

Application of this Policy to Persons Who Cease to be Associated with the Company

 

The laws against insider trading continue to apply to anyone who has material non-public information about the Company.  Therefore, even if an individual ceases to be employed by or associated with the Company, that person is prohibited by law from trading any securities of the Company for so long as he or she possesses material non-public information.

 

  

22

  

 

Company Assistance

 

Any person who has any questions about specific transactions or this Policy in general may obtain additional guidance from the Policy Administrator.  Remember, however, the ultimate responsibility for adhering to the Policy and avoiding improper transactions rests with you.  In this regard, it is imperative that you use your best judgment.

 

Certifications

 

As a condition to continuing employment, all employees will be required to certify their understanding of and intent to comply with this Policy.  Members of the Board of Directors, Senior Management and other personnel may be required to certify compliance on an annual basis.

 

Certification

 

The undersigned hereby certifies that he/she has read and understands, and agrees to comply with, the Company’s Statement of Company Policy regarding Securities Trades by Company Personnel, a copy of which was distributed with this Certification.

 

	Date: __________________________	
Signature ________________________

 

Name: ____________________________

                  (Please Print)

 

  

23

  

Exhibit F

BIOLINERX LTD.

Intra-Organizational Enforcement Plan

Pursuant to and in accordance with the Law for the Improvement of Internal Enforcement Proceedings in the Israel Securities Authority, 5770-2010

 

 

This plan was approved by the Board of Directors of the Company on December 22, 2012 and has been updated as of October 2013.

  

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1.

	
Contents

 

	
2. 

	
Senior officer declaration

 

	
3. 

	
General information on an administrative enforcement plan

 

	
4. 

	
Organizational structure and division of functions and responsibility

 

	
5. 

	
Guiding principles/issues addressed

 

	
6. 

	
Appointment of an internal enforcement officer

 

	
7. 

	
Contact and reporting

 

	
8. 

	
Sanctions in events of violations and failure to report

 

	
9. 

	
Findings of mapping of the existing situation

 

	
10. 

	
Relevant procedures

 

	
11. 

	
Assimilation plan

 

	
12. 

	
Annex A

 

  

25

  

 

	
2.

	
Senior officer declaration

 

	
2.1

	
CEO’s message

 

The status of BioLineRx as a public company confers on it both advantages and responsibility. The main market for trading the Company’s shares is the Tel Aviv Stock Exchange. Therefore, we are subject to the Israeli Securities Law and the enforcement thereof by the Israel Securities Authority (“ISA”). When the ISA learns of breaches of the law, it has the power to sue companies and individuals in criminal proceedings and (after amendments to the law from 2011) to impose fines and other sanctions without the need to apply to the courts.

 

The administrative enforcement plan is intended to help us comply with the law, to correctly address violations and to demonstrate to the ISA that we treat seriously anything that is related to the offering of our shares. Understanding the plan and enforcing it in day-to-day life provides a solid basis for the investors’ trust in particular and for the Company’s public reputation in general.

 

Similarly to our code of business and ethics, this plan is intended for each and every Company employee, manager and Board member.

 

I request and expect your personal commitment to the enforcement of the procedure and full cooperation in its application.

 

This procedure is a living procedure which may change from time to time pursuant to relevant laws and regulations and according to the lessons learned during the assimilation of the plan.

 

I trust each and every one of you to comply with both the written plan and its spirit.

 

Dr. Kinneret Savitsky

CEO

  

26

  

 

	
3.

	
General information on an administrative enforcement plan

 

	
3.1

	
Improvement of Internal Enforcement Proceedings in the ISA Law, 5770-2010

 

The Law for the Improvement of Internal Enforcement Proceedings in the Israel Securities Authority, 5770-2010 (the “Law”), which was approved by the Knesset in January 2011, constitutes a significant change that requires reporting companies to immediately address the requirements of the new Law. The main parts of the Law regulate the establishment of an administrative committee that will deal with violations in the area of securities. If the committee reaches the conclusion that it was proven at the level of proof which is customary in civil law (a probability of more than 50%) that a violation was committed, it will be authorized to institute various means of enforcement against the violating party.

 

The committee will deal with various violations that are related to the Securities Law, 5728-1968 (the “Securities Law”) and other relevant laws. The common feature of such violations is that the mens rea that is set forth therein is at most that of negligence.

 

The means of enforcement that the committee will be authorized to impose will be significant fines, a demand to pay damages to the party injured by the violation, a payment to the State treasury which derives from profits that were generated as a result of the violation, a demand to institute acts to remedy the violation and prevent its recurrence, a prohibition on holding office in certain bodies, a suspension or revocation of a license and suspended punishment.

 

As is known, the Law establishes, inter alia, the strict responsibility of the CEO, due to which enforcement measures can be imposed as set forth in the Law.

 

	 	
(a)

	
“The CEO of the corporation and a partner other than a limited partner, are obligated to supervise and institute any and all reasonable means under the circumstances of the case to prevent the commission of a violation by the corporation or partnership, as the case may be, or by any of their employees.”

	 	
(b)

	
If a violation is committed the presumption is that the CEO of the corporation or a partner other than a limited partner in the partnership, as the case may be, has breached his obligation pursuant to Subsection (a) and may be subject to one or more of the means of enforcement as specified below...unless he proves that he has fulfilled his obligation pursuant to Subsection (a):

	 	
(c)

	
If the corporation has established adequate procedures to prevent a violation as provided in Subsection (b), appointed an officer on its behalf to supervise the compliance therewith, including with regard to providing guidance to the corporation’s employees for the compliance therewith, and instituted reasonable steps to remedy the violation and prevent the recurrence thereof, the presumption is that the CEO or the partner, as the case may be, has fulfilled his obligation as provided in Subsection (a).

 

According to commentators, all the provisions of Subsection (c) lead to an internal enforcement plan. So, too, thought the Israel Securities Authority (the “ISA”), when in August 2011 it released a Document on criteria for recognition of an internal enforcement plan in the area of securities and investment management (the “ISA Document”) and set forth that:

 

“The application in practice of an efficient enforcement plan by the corporation may be viewed favorably by the ISA with respect to the corporation or individuals therein in the context of its discretion in respect of the exercise of its powers of enforcement pursuant to the law.”

 

The ISA’s Document sets forth the standards that will be examined by the ISA when deliberating and deciding whether an efficient enforcement plan exists at a corporation. Based on the requirements of the Law, the ISA’s Document and the understanding of the Company’s management, the relevant information and instructions have been incorporated into the enforcement plan document that is set forth below.

 

	
3.2

	
What is an enforcement plan

 

This internal enforcement plan document is a document that is unique to the Company which set forth the activities to be undertaken in order to prevent the violations listed in the schedule to the administrative enforcement law.

 

  

27

  

 

	
3.3

	
Objectives of an enforcement plan

 

The creation, implementation and assimilation of a correct and suitable enforcement plan can constitute a dual safety mechanism for the Company and the individuals therein:

 

	
ü

	
Minimization of the possibility of the occurrence of a violation

 

Through the establishment of clear procedures, presentation of standards for conduct and implementation of controls for the application thereof in the day-to-day activity, ensuring that any and all individuals taking part in the Company’s relevant activity are aware of their obligation and the manner of their compliance therewith.

 

	
ü

	
Immediate effect on the examining entity in the event that a violation occurs

 

As stated in the Law and in the ISA’s Document, an enforcement plan is an indication that the Company (its managers and directors) has done everything within its power to try to prevent violations. Such a plan will provide a defense to their benefit whereby they have instituted any and all reasonable measures to prevent the offence for a body which is examining and/or dealing with an occurrence of a violation.

 

The primary objective of the enforcement plan is to ensure the proper activity of the Company in accordance with any and all regulatory obligations and desired standard of conduct insofar as the same are relevant to the Securities Law and the regulations promulgated thereunder.

 

The plan intends to establish existing proper conduct, to create a compilation of information and procedures that are relevant to the organization and to assimilate the conduct which is desired and required of each and every one of the Company’s employees and officers and to promote an organizational culture of compliance with and respect for the Law.

 

All employees and/or officers should be able to consult the document if and when they encounter an issue pertaining to the content of the plan and to find answers with regard to the conduct that is appropriate and expected of them, whether it is a procedure which offers guidance on how to act or a referral to consultation with a relevant body.

 

	
3.4

	
Applicability of the enforcement plan

 

This plan applies to BioLineRx (the “Company”) by virtue of its being a public company whose shares are listed on the Tel Aviv Stock Exchange. The plan applies to all of the Company’s echelons, i.e. the Company’s employees, senior officers, managers and directors. It is important to emphasize that the plan also applies to the employees of any and all subsidiaries of the Company in view of their involvement with the operations of the parent company.

 

	
3.5

	
Prohibition on insurance and indemnification

 

The Law explicitly contains a prohibition on insurance and/or indemnification in respect of violations of the Law.

 

The Law establishes that a proceeding to impose a pecuniary sanction, an administrative proceeding or an arrangement proceeding cannot be insured. A pecuniary sanction imposed on a corporation, its controlling shareholder or an employee in a proceeding as aforesaid cannot be indemnified or paid, either directly or indirectly.

 

However, an employee can be indemnified or insured for payment to the party injured by the violation and additionally for expenses that he shall have incurred in relation to a proceeding that was conducted in the matter of the employee, irrespective of the results of the proceeding.

 

In November 2011, the Company’s articles of association and letters of insurance and indemnification of the officers were updated accordingly, such that a provision was set forth that permits the insurance and/or indemnification pursuant to the provisions of the Securities Law.

 

	
3.6

	
Documentation and provision of documents for inspection and storing of documents

 

The Law and the schedules include a reference to the issue of providing documents for inspection. As part of the enforcement plan and its procedures, the Company is obligated to make available for inspection any and all relevant documents (for example, a prospectus that was authorized for publication, a registration document or any and all reports, opinions, approvals, reports or notices that were filed) at its head office.

 

Relevant procedures shall specify the responsibility for the fulfillment of the right of inspection insofar as will be required.

 

	
4.

	
Organizational structure and division of functions and responsibility

 

	
4.1

	
Organizational structure for the issue of administrative enforcement (areas of responsibility, reporting chain, decision making, etc.)

 

  

28

  

 

	
  

	
4.1.1

	
Responsibility of the Board of Directors and its committees

 

	
  

	
4.1.1.1

	
Formulation and adoption of the Company’s internal enforcement plan

 

As the body responsible for outlining the Company’s policy and supervising its performance and acts, the Board of Directors (including its committees) plays a central and decisive role in the formulation and adoption of the Company’s internal enforcement plan and it bears the overall responsibility for the supervision over the actual performance thereof.

 

Pursuant to the ISA’s requirement that the Board of Directors determine which body is responsible for the supervision over the performance of the enforcement plan (the “Responsible Body”), whether the Board of Directors itself or the Audit Committee or any other committee thereof, the Board of Directors determined that the Audit Committee shall be the Responsible Body as aforesaid.*

 

Such responsibility of the Audit Committee as the Responsible Body shall be applied through:

 

	
  

	
1.

	
Special-purpose meetings for the presentation of the subject.

 

	
  

	
2.

	
Presentation, discussion and approval of the outline of the enforcement plan project.

 

	
  

	
3.

	
Presentation of the findings of the mapping of the existing situation (compliance survey) and deliberation on the recommendations deriving therefrom.

 

	
  

	
4.

	
Presentation, discussion and approval of the procedures comprising the internal enforcement plan.

 

	
  

	
5.

	
Approval of the final plan.

 

The Audit Committee shall be involved in the implementation of the plan during the usual conduct of business as specified below.

 

The Audit Committee, including all of the members thereof, will take an active part in all stages of the formulation and adoption of the plan:

 

	
  

	
·

	
Setting the enforcement plan into motion

 

	
  

	
·

	
Mapping of the existing situation

 

	
  

	
·

	
Formulation of the plan and its procedures

 

	
  

	
·

	
Formulation of the assimilation plan

 

	
  

	
·

	
Ongoing monitoring

 

This Plan was approved by the Audit Committee on March 21, 2012 and by the Board of Directors on March 22, 2012.

 

	
  

	
4.1.1.2

	
Implementation of the plan

 

The Responsible Body shall oversee the enforcement plan and ensure that it is executed by way of receiving periodic reports from the Enforcement Officer and management, discussing them same and examining the means of action employed by the Company as arising therefrom. The Audit Committee shall ensure that the Audit Committee and management review the need to update and refresh the plan once a year.

 

The implementation of the plan shall be performed inter alia through ongoing reporting as specified above and through the assimilation plan as the same is specified in Chapter 11 of this plan.

 

	
  

	
4.1.1.3

	
Supervision of the enforcement plan

 

The Responsible Body, i.e. the Audit Committee, shall supervise the plan’s performance. To this end, the internal auditor’s audit plan for 2013, includes follow-up of the implementation of the administrative enforcement plan.

 

	
  

	
4.1.1.4

	
Handling violations of the enforcement proceedings

 

The Responsible Body shall ensure that the provisions of the enforcement procedures are applied in practice. In addition, the Responsible Body shall ensure that violations of the plan will be appropriately handled, the deficiencies corrected, conclusions drawn, and in the appropriate cases, measures taken against the violating parties.

 

(*)           Relevant quotations from the minutes of the Board of Directors and Audit Committee are attached hereto, marked as Annex A.

 

  

29

  

 

The manner of contact and reporting is specified in Chapter 7 of this plan and was approved by the Audit Committee and Board of Directors as part of the plan’s approval. The Company shall approve in each procedure separately, insofar as necessary, the required sanctions and disciplinary action.

 

	
  

	
4.1.1.5

	
Reporting to the Board of Directors and the Audit Committee

 

The Audit Committee as the Responsible Body or a body authorized thereby shall report as needed and at least annually to the Board of Directors on the implementation of the enforcement plan and related issues at the Committee’s discretion.

 

A report to the Board of Directors may include but is not limited to supervision of the implementation of the plan through demanding periodic reports on the approval of the enforcement plan, updating the plan and its procedures, appointing relevant bodies, and the results of the supervision of the implementation and effectiveness of the plan.

 

	
  

	
4.1.2

	
Responsibility of the CEO/management – steering committee

 

The ISA’s Document provided that the CEO is the officer with supervisory responsibility to ensure the compliance of the Company and its employees with the securities laws through the shaping of the internal enforcement mechanisms.

 

Management is responsible for the shaping and formulation of the enforcement plan and its presentation for the Audit Committee’s approval. In addition it is responsible for the ongoing implementation of the plan.

 

Management shall act through the Enforcement Officer, Adv. Norman Kotler, as appointed on February 5, 2012, and through the Chief Financial & Operating Officer, Philip Serlin, CPA.

 

As part of the fulfillment of such obligation, the CEO has appointed a steering committee to shape the internal enforcement mechanisms. The steering committee includes the following:

 

Chief Financial & Operating Officer

 

Executive Director of Finance and Reporting

 

General Counsel and Internal Enforcement Officer

 

The steering committee is responsible for shaping the enforcement mechanisms, performing the compliance survey, writing the enforcement and assimilation plan and obtaining the suitable approvals from the relevant bodies.

 

	
  

	
4.1.3

	
Responsibility of the Chief Financial & Operating Officer

 

The Chief Financial & Operating Officer, as management’s representative, is responsible for leading and managing the process of writing the enforcement plan and determining the mechanisms included therein.

 

Such power includes review and approval of the compliance survey, the enforcement plan and the procedures included therein.

 

The Chief Financial & Operating Officer as the direct supervisor of the Enforcement Officer shall supervise his activity as the officer responsible for internal enforcement.

 

	
  

	
4.1.4

	
Responsibility of the General Counsel and Internal Enforcement Officer

 

The General Counsel of the Company, as the officer in charge of the compliance culture and proper corporate governance in the Company and as the officer responsible for the compliance of the Company, its officers, managers and employee with the laws and regulations that apply to them, is involved in shaping, implementing and ensuring the compliance with the enforcement plan and examining the suitability of the mechanisms set forth in the enforcement plan and its procedures to the laws that apply to the Company.

 

The General Counsel shall take an active part in the deliberations of the steering committee of which he is a member, and by virtue of his appointment as the Internal Enforcement Officer (also to be referred to in this plan as the “Officer”) at the Company shall act to fulfill his obligations.

 

Responsibility

 

The Officer shall in practice lead the implementation of the enforcement plan. Powers shall be conferred on the Officer, enabling him to carry out the processes and mechanisms included in the enforcement plan and that are inter alia specified in the standards in the ISA Document and in Chapter 6 of this plan, “Appointment of the Enforcement Officer”.

 

  

30

  

 

The Officer’s responsibilities and the acts for the implementation of the enforcement plan are specified in the assimilation plan in Chapter 11.

 

For any question or query on the issue of the enforcement plan, please contact the Officer:

 

Adv. Norman Kotler

E-mail: normank@biolinerx.com

Tel. 02-5489139

 

Determination of a work plan for the fulfillment of all of his obligations pursuant to this plan

 

The Officer shall be responsible to add as an annex

 

	
  

	
4.1.5

	
Internal auditor’s responsibility

 

The Internal Audit Law, 5752-1992, provides that the internal auditor of the Company is, inter alia, the body responsible for the examination of issues such as:  the propriety of the actions of the Company and the officers, the fulfillment of the provisions that are binding on the Company and the carrying out of decision-making processes according to proper procedures and, consequently, contributes to the Company’s compliance and enforcement mechanisms.

 

In accordance with his or her in-depth familiarity with internal control at the Company, the internal auditor shall take an active part in the deliberations and shaping of the enforcement plan insofar as will be required.

 

Ongoing supervision:

 

One of the roles of the internal auditor in the context of an enforcement plan is supervising the activity of the Officer and the enforcement plan (as defined in the ISA Document).

 

In order to perform such role, the auditor shall set include a periodic audit in his or her work plan, which may include:

 

Examining the relevance and effectiveness of the enforcement plan, the effectiveness of the Officer’s actions, examining the compliance with the enforcement plan and its procedures once every four years, handling irregular cases that were identified, completing the acts required in the enforcement plan within the required timelines.

 

  

31

  

 

 

	
5.

	
Guiding principles/issues addressed

 

BioLine is a dual-listed company that is listed on the Tel Aviv Stock Exchange and on NASDAQ in the U.S.

 

The Company’s reporting obligations derive mainly from the requirements of the U.S. Securities and Exchange Commission (“SEC”), and the reports deriving from its compliance with SEC’s requirements are also published in the ISA’s reporting system.

 

Pursuant to an examination of the violations in the Fifth and Seventh Schedules to the Law, and an examination of the relevance to the Company by the General Counsel and the Officer, the following issues were found to be relevant to the enforcement plan.

 

	
5.1

	
Prospectus/annual report process

 

Corporations publish a prospectus as part of the process of offering securities or bonds. In addition, under U.S. law, the Company is required to file an annual report with the SEC. The process of preparation of the annual report is similar to the one related to the preparation of a prospectus. The purpose of the prospectus and the annual report is to provide to the general public and to the reasonable investor in particular information that is essential to the decision to purchase the Company’s securities.

 

In view of the Company’s dual listing, it is obligated to institute a process with regard to a prospectus or annual report (and which is relevant to the process at the main stock exchange) upon the completion of which, the Company shall be able to publish a full, reliable and up-to-date prospectus or report that is approved by any and all relevant bodies and meets all of the regulatory requirements.

 

The process shall be regulated in the context of a procedure or a checklist, specifying the acts that are required and which shall be updated from time to time and as necessary.

 

	
5.2

	
Reports to the SEC and ISA

 

The purpose of the reports to the ISA is to update the investors and supervisory bodies on the Company’s condition and on developments or changes in its activity that may be relevant to the investing public. The Company’s reports are based on the reports to the SEC and which are required thereby.

 

All of the reports must include full, reliable and current information and to fulfill any and all relevant regulatory requirements.

 

A reporting obligation exists in various cases which affects the content and manner of reporting. This plan deals with three issues that arise from the obligations that apply as a result of the Fifth and Seventh Schedules

 

5.2.1           Periodic reports – In addition to an extensive annual report, a public company is required to release financial statements on a quarterly basis. In the Company’s case, the structure and content of the reports are audited and supervised according to international accounting standards and the rules of the SEC.

 

Establishing an internal procedure regarding periodic reporting will assist the Company in minimizing the risks related to the deadline for and appropriateness of the periodic reporting, and the fulfillment and enforcement thereof will assist in the prevention of failures on the part of employees and officers with regard to the subject, directly or indirectly.

 

5.2.2           Immediate reports – BioLine, as a dual public company, is required to immediately report (according to SEC’s reporting rules) material events which may have an effect on the price of the Company’s securities. The identification of the need to report, the decision on the need to report, the weighing of conflicting interests, the timing and content of the report, requires the Company to have an orderly process, which includes the identification of information which may have to be reported, the consultation with regard to the need to report, and the actual reporting, all within the timeframes prescribed in by applicable regulations.

 

The purpose of establishing a process and determining rules of activity and conduct is to provide current, accurate and full reporting to the SEC, the ISA and the public, on issues that are regulated in the securities laws and the regulations thereunder.

 

Establishing an internal procedure regarding immediate reports will assist the Company in minimizing the risks related to the deadline for and appropriateness of the periodic reporting, and the fulfillment and enforcement thereof will assist in the prevention of failures on the part of employees and officers with regard to the subject, directly or indirectly.

 

  

32

  

 

	
5.3

	
Prohibition on the use of inside information

 

Inside information is “information on developments in the company, changes in its condition, expected developments or changes, or other information about the company, which is unknown to the public and which, were it to become known to the public, would result in a material change in the price of the Company’s security or the price of another security of which the Company’s security is a basic asset.” It was determined in the legislation that the use of inside information for the purpose of a securities transaction or its transmission to another, are prohibited by law.

 

Each corporation is required to adopt rules and guidelines in order to fulfill Chapter H1 of the Securities Law including all of its provisions, as well as the U.S. laws which relate to such issue, all in order to prevent the use of inside information by the Company’s employees and other bodies.

 

It is necessary to put in place a process to cover the identification of the sensitive information, clarify the prohibition to use the same and assimilate it among any and all persons who come into contact with such information.

 

Establishing an internal procedure regarding the use of inside information will assist the Company in minimizing the risks related to the deadline for and appropriateness of the periodic reporting, and the fulfillment and enforcement thereof will assist in the prevention of failures on the part of employees and officers with regard to the subject, directly or indirectly.

 

	
5.4

	
Transactions with interested parties

 

Interested party transactions are transactions entered into between one of the interested parties of the company (or between a company affiliated with that party or a person related to it) and the company. Such transactions contain a potential for a conflict of interests that is higher than in ordinary transactions. Therefore, applicable laws and regulations set forth conditions to the approval of such type of transactions, inter alia, the manner of approval thereof by various organs of the corporation (including, under circumstances set forth in the law, an approval by a general meeting of a majority of the shareholders of the company from among the those shareholders who do not have a personal interest in relation to the transaction), and the disclosure to the public of the terms and conditions of the transaction.

 

In view of the regulatory requirements concerning the identification of such transactions, the manner of approval thereof and reporting thereon, a controlled process should be put in place concerning the subject, in order to reduce the related risks and assist in the prevention of failures in the matter.

 

	
5.5

	
Procedure for period end closing

 

In accordance with the Companies Law, 5759-1999, the Securities Law and U.S. securities laws, public companies must abide by all disclosure rules and prepare proper financial statements covering all accounting operations. Companies must therefore operate in accordance with orderly and well-defined work procedures, and generate reports conform to accepted accounting practices, according to the provisions of the law. The procedure for period end closing, which is in the advanced stage of drafting, intended to set in order the preparation of the Company’s financial statements.

 

  

33

  

 

	
6.

	
Appointment of an Internal Enforcement Officer

 

	
6.1

	
Appointment of an Officer

 

The Officer shall have the skills, knowledge and experience that are appropriate for his position and areas of responsibility and shall be a manager in the Company who is familiar with the Company’s activity and the business and regulatory environment in which it operates.

 

The Company’s management and the Audit Committee shall ensure that the Officer is given the powers and provided with suitable resources such that they will enable him to fulfill his duties and exercise his powers (as will be specified below) in an optimal manner.

 

	
6.2

	
The appointment and approval (and change) process

 

The candidacy of the Officer shall be presented to the Audit Committee together with management’s recommendation to appoint him as the Officer, after the presentation of his skills and experience. For the purpose of management and implementation of the internal enforcement plan, on February 5, 2012, the Audit Committee appointed Adv. Norman Kotler for the position of Internal Enforcement Officer.1

 

As set forth in the ISA Document, it was determined that the appointment of a new officer and/or removal of the Officer from his position require the management’s recommendation and the approval of the Audit Committee.

 

	
6.3

	
Powers

 

The Officer’s first and foremost authority is to implement the internal enforcement plan and lead the actual acts of enforcement pursuant to the plan,the requirements of the Law and the recommendations of the ISA and/or any other relevant body.

 

The Officer’s powers include but are not limited to the powers listed in the ISA Document:

 

	
  

	
6.3.1

	
Ongoing supervision:

 

The Company, through the Officer, shall ensure on an ongoing basis that the plan is actually implemented in order to achieve its goals as specified above.

 

Such supervision shall be performed through:

 

Formulation of periodic reports which include the means and actions that were taken in order to ensure the implementation of the plan, suspicionsof violations that were raised and how they were addressed, examination of relevance, updates and progress of assimilation of the plan, etc.

 

Presentation of the reports to the Company’s management and/or Audit Committee and/or Board of Directors and deliberation on the data reported by the forum to be determined.

 

Reporting of issues requiring immediate attention to the Company’s management and/or Audit Committee and/or Board of Directors.

 

Documentation of the processes related to formulation of the plan, and the means that were instituted to implement the plan and to handle violations, as well as documentation, provision of documents for inspection and preservation of documents pursuant to the provisions of the Law.

 

	
  

	
6.3.2

	
Investigating suspected violations:

 

In any case of a suspected violation brought to his knowledge, the Officer shall act to investigate the facts together with a special-purpose team to be appointed by the Chief Financial & Operating Officer, and if it transpires that there was a failure and a violation has occurred, he shall examine the reasons for the failure.

 

	
  

	
6.3.3

	
Remedying the violation:

 

The Officer shall act to remedy the discovered violation or failure as soon as possible and in accordance with the guidelines and approvals of the relevant bodies (the committee, managers and officers that are affected by the change, etc.)

 

	
  

	
6.3.4

	
Reporting the violation:

 

The Officer shall report the failure to the CEO, Chief Financial & Operating Officer, and according to the severity of the case, also to the chairman of the Audit Committee/Board of Directors, all according to the reporting requirements in this plan.

 

Insofar as the CEO and/or Chief Financial & Operating Officer are involved in the failure, the Officer shall contact the chairman of the Audit Committee. Insofar as the members of the Committee are involved in the matter, the Officer shall contact the internal auditor.

 

1See quote from the minutes of an Audit Committee meeting dated February 5, 2012, which appears in Annex A.

 

  

34

  

 

	
  

	
6.3.5

	
Preventing the recurrence of the violation

 

The Officer shall introduce new procedures or amendments to existing procedures, as well as controls over them, and approve the same with the relevant bodies. For the sake of clarity, by virtue of his position as the General Counsel of the Company, and for the purpose of performing his role as the Officer, the Officer shall have direct access at all times to any and all offices and documents of the Company and to any and all records and information at the Company, all as required, in his discretion, for his work.

 

Naturally, any and all inquiries and actions performed at the Company as part of the enforcement plan shall be performed in accordance with the law and without harming or disrupting any investigation or inquiry by law of which the Company is aware.

 

In any case of doubt whether or not an issue is within the Officer’s jurisdiction, the Officer or any other party shall consult with the Audit Committee.

 

	
6.4

	
Supervision over the Officer

 

As stated above, and as will be further specified below, the Audit Committee is responsible for the appointment and the termination of the appointment of the Officer.

 

The Chief Financial & Operating Officer is the direct supervisor of the General Counsel and Officer, and authority is conferred on him accordingly.

 

The supervision over the Officer’s activity and the implementation of the enforcement plan is within the responsibility of the internal auditor in the context of his or her ongoing work and at the request of the Audit Committee (such supervision shall be performed pursuant to the audit plan to be approved by the Audit Committee).

 

	
6.5

	
Officer’s reporting responsibility

 

The Officer shall report a failure to the CEO, Chief Financial & Operating Officer, and according to the severity of the case, also to the chairman of the Audit Committee/Board of Directors, all according to the reporting requirements in this plan.

 

The report to the Chief Financial & Operating Officer shall be performed after an initial inquiry proceeding by the Officer that shall include an initial factual inquiry.

 

The report to the Chief Financial & Operating Officer shall be performed no later than two working days after having first learned of the suspected violation, and in any event, no later than four days from the date on which the report shall have been made to him.

 

Insofar as the Chief Financial & Operating Officer and/or CEO are involved in the failing, the Officer shall contact the chairman of the Board of Directors or the Audit Committee. Insofar as members of the Audit Committee are involved in the matter, the Officer shall contact the internal auditor.

 

	
7.

	
Contact and reporting

 

	
7.1

	
Possibilities of contact and reporting in the event of a suspected violation

 

According to requirements and expectations, the Company has set forth internal mechanisms which enable the officers, directors, employees and service providers of the Company to report and warn about deficiencies and failures in relation to the fulfillment of the provisions of the securities laws or violations of the plan.

 

The reporting mechanisms for administrative enforcement issues shall be identical to those prevailing at the Company (reporting mechanisms upon a breach of the code of ethics, contacting and reporting to the internal auditor, etc.).

  

35

  

 

	
  

	
a.

	
Employees, officers and directors

 

In any case of a suspected violation or improper conduct, the Company’s employees, officers and directors have the possibility (and sometimes the obligation) to contact their direct supervisor, the internal auditor and/or the chairman of the Audit Committee.

 

	 	
Internal Auditor, Linur Dloomy, CPA

	
Audit Committee Chairperson, Nurit Binyamini

	 	 	 
	 	
E-mail: ldloomy@deloitte.co.il

	
E-mail: Nurit378@gmail.com

	 	 	 
	 	
Tel. 052-5838635

	
052-6440745

 

	
  

	
b.

	
Service providers

 

The Officer is responsible for adding a method of reporting by external parties.

 

In order that all relevant parties shall be aware of their reporting obligation and of the various possibilities of reporting a possible suspected violation, this information shall be passed on to all relevant parties in the context of this document, the training programs, the Company’s website, engagement agreements, employment documents, etc.

 

All of the relevant parties shall be familiar with the existence of the enforcement plan, the main parts of the plan and where it may be inspected, as well as the method of reporting and the rights of the reporting party (anonymity/confidentiality/favorable consideration in the event that he is the violating party, etc.).

 

The Officer shall confirm that once a year the aforesaid information is communicated to relevant bodies in an initiated manner (for example a dedicated e-mail)

 

The Officer shall confirm that the manner of approaching him is available at all times.

 

	
7.2

	
[intentionally omitted]

 

	
7.3

	
External reporting

 

There are situations in which a violation or a suspected violation of the securities laws requires reporting to the competent authorities (the ISA or the Israeli Police, as the case may require).

 

Even in those cases in which there is no reporting obligation, voluntary disclosure should be considered, since the ISA Document states that the ISA’s enforcement considerations in exercising its powers in respect of corporations and individuals include the factors of voluntary disclosure by the corporation and the corporation’s cooperation with the ISA.

 

Situations where there is a legal obligation to report to the ISA include among others situations in which an item was published which may mislead a reasonable investor or trading was done based on inside information.

 

In all situations in which there is no reporting obligation, the Officer shall discuss the need to report with the Chief Financial & Operating Officer and outside legal advisors. Their conclusion and the considerations that led thereto shall be brought for deliberation by the Audit Committee which shall be convened for such purpose.

 

General Counsel together with the Chief Financial & Operating Officer shall report to the competent authorities in accordance with the Company’s decision and soon after the date of the decision.

  

36

  

 

	
8.

	
Sanctions in events of violation and failure to report

 

As mentioned above, one of the functions of an enforcement plan is to encourage an organizational culture of compliance with, and respect for, the law. The ISA Document makes clear that “a culture of compliance means that the corporation is obligated to prevent violations of the law and to handle violations and violating parties with the appropriate measures.”

 

	
8.1

	
Determination of sanctions in events of violation

 

In view of the ISA determination that “the Company shall institute suitable measures against violating parties, including, in appropriate cases, disciplinary action in respect of anyone violating the provisions of the securities laws or the provisions of the enforcement plan”, the Company shall set forth in each procedure separately, insofar as necessary, the disciplinary action that is required.

 

	
9.

	
Findings of a mapping of the existing situation

 

Pursuant to Chapter 7 in the ISA Document: “Adjustment of the plan to the corporation and the unique circumstances thereof, after the performance of a compliance survey in the area of the securities laws”.

 

A summary of the first survey that was performed by Deloitte – Brightman Almagor Zohar, the Company’s consultants for the enforcement plan project, is available in the Officer’s files.

 

	
10.

	
Relevant procedures

 

Pursuant to the compliance survey, the Company has formulated the internal procedures that are specified below, while considering the Company’s structure, its unique features, and the potential risks and deficiencies in the area of the compliance with the securities laws to which it is exposed. The role of the procedures is to regulate and determine rules of activity and conduct, the purpose of which is to prevent violations of securities laws as well as to create work processes which will address and control such processes.

 

	
10.1

	
Statement of Company Policy – Securities Trades by BioLineRx Ltd. personnel

 

The draft procedure was approved by the Board of Directors on May 15, 2012. The procedure in its final form was approved by the Company’s management on June 6, 2012. The Chief Financial and Operating Officer was appointed as the officer responsible for the procedure.

 

The procedure is relevant to all of the Company’s employees and to those who come into contact with information which may constitute inside information.

 

	
10.2

	
Transactions involving interested and related parties

 

The procedure was approved for the first time in December 2010. An amendment to the procedure was approved by the Company’s management on July 3, 2012 and by the Audit Committee and Board of Directors in November 2012.

 

The Executive Director of Finance and Reporting and the General Counsel were appointed as the officers responsible for the procedure.

 

The procedure is mainly relevant to directors, other officers, the finance department and the General Counsel.

 

	
10.3

	
Procedure for prospectus/annual report/other reports to the SEC and ISA (Disclosure Controls)

 

The procedure was approved by Company management in September 2012 and by the Audit Committee and Board of Directors in November 2012.

 

The Chief Financial and Operating Officer and the General Counsel were appointed as the officers responsible for the procedure.

 

The procedure is relevant primarily to the Finance Department and the General Counsel

 

	
10.4

	
Period end closing procedure

 

(in progress)

 

Approved on ____________

 

Appointed as procedure officer: Manager of Reporting and Control

 

The procedure is relevant to the Chief Financial and Operating Officer and the Finance Department

 

  

37

  

 

	
11.

	
Assimilation plan

 

11.1           Background

 

An enforcement plan is a mechanism to encourage compliance which is binding on all of a company’s employees, managers and officers.

 

This document is not intended just for display and the familiarity with its content and the implementation hereof are material to the Company.

 

Therefore, the Company examined various possible mechanisms for the purpose of assimilation of the enforcement plan and the procedures related hereto, and established the selected mechanisms in an assimilation plan that is brought below.

 

The purpose of the assimilation plan is to promote and ensure the commitment of all of the relevant parties to the plan, their knowledge of the main parts hereof and the actual implementation hereof in all of their activity.

 

11.2           Presentation of the enforcement plan

 

After the completion of the enforcement plan and its approval by the relevant bodies, the plan shall be presented to all of the employees and managers at a Company meeting. At such meeting, the CEO of the Company shall present the main parts of the plan, the importance of compliance herewith, the role of the Enforcement Officer and the manner of publication of the plan.

 

Following the presentation of the plan, the plan and the procedures related hereto shall be posted on the Company’s website (path/link) and be sent via e-mail to the distribution list of all of the Company’s employees and managers.

 

A printed copy is to be kept at the offices of the Company’s CEO, Enforcement Officer and the Company’s auditor.

 

The Enforcement Officer shall examine the need for updating the general documents of the Company (like, for example, disciplinary code, the employment agreements, code of conduct, etc., as well as specific related procedures – employee initiation procedure, inside information procedure, etc.) in order that they include a reference to the subject of administrative enforcement.

 

	
From the ISA Document:

 

Measures shall be taken in order to ensure the commitment of all echelons of the corporation to the aforesaid procedures, for example, through the establishment of such commitment in the disciplinary code or employment agreements.

 

11.3           Implementation and assimilation of the enforcement plan

 

Publication of the enforcement plan

 

The enforcement plan shall be published on the Company’s portal/website and distributed via e-mail to all of the Company’s employees.

 

Following any updates of the enforcement plan, an e-mail shall be sent with a summary of the changes to all of the Company’s employees.

 

Team/forum of assimilation of the administrative enforcement plan

 

The steering committee referred to in Section 4.1.2 shall arrange for the implementation of the internal enforcement assimilation plan and the approval of any updates or modifications that will be performed.

 

New employee

 

Each new employee, upon his or her arrival at the Company and in the context of the employee’s initiation process as conducted by HR, shall be given access to the enforcement plan, be required to read the main parts hereof and sign that he or she has read the plan.

 

During the first month of his employment, the new employee will be required to participate in training by the Internal Enforcement Officer on the subject of administrative enforcement.

 

  

38

  

 

New officer

 

Each new officer shall participate in a talk with the Administrative Enforcement Officer at which the internal enforcement plan will be presented to him. At the end of the meeting, the officer shall sign a document in which he declares that he has read the plan and undertakes to comply with all provisions hereof that are relevant to him. The officer shall also receive a copy of the plan via e-mail or a link to its location on the Company’s website.

 

Assimilation and periodic communication – Company employees and managers

 

In order to ensure that all employees are aware of the obligations that apply to them by virtue of the Improvement of Internal Enforcement Proceedings in the ISA Law and the enforcement plan, a training session procedure shall be assimilated for all of the Company’s employees and managers as well as the Company’s officers.

 

Alternatives:

 

	
  

	
a.

	
Frontal training sessions shall be held by the Officer on behalf of the Company or by an outside body. The training sessions shall be performed at least once a year. The training sessions shall include a review of the enforcement plan, possible violations and reporting methods.

 

	
  

	
b.

	
Written training sessions. At least once a year the Officer shall send a presentation via e-mail to the employees that will include an employee guide – a review of the enforcement plan, possible violations and reporting methods. The employee shall be required to send a return e-mail to the Officer in which he confirms that he has read the content of the guide and undertakes to act according thereto.

 

The course presentation shall be attached as an annex.

 

Each employee shall complete the course at least once a year.

 

Every November the Officer shall distribute a request via e-mail to all of the Company’s employees and managers to complete the course within one month from the e-mail’s distribution date.

 

Toward the expiration of such period (about one week before the target date) the Officer shall distribute a reminder e-mail to all of the Company’s employees and managers. At the end of the period the Officer shall examine the response rate. In each case where an employee/manager shall have failed to fulfill the request, the Officer shall send an e-mail to the aforesaid employees and their managers, informing that they are required to complete the course and the proficiency test within 5 working days. Employees and managers who will fail to fulfill such demand shall be liable for sanctions by the Company pursuant to Chapter 8 of the enforcement plan.

 

The Enforcement Officer shall confirm that 100% of the Company’s employees and managers have participated in the course over the year. At the end of the year, the Enforcement Officer shall issue a report with regard to the administrative enforcement which shall include the percentage of the employees who shall have participated in training in such year.

 

The course shall be maintained and updated by the Enforcement Officer pursuant to changes in the enforcement plan and/or the assimilation plan.

 

Assimilation and periodic communication – officers/Board of Directors

 

The officers and Board of Directors shall participate in frontal training sessions held by the Officer on behalf of the Company or an outside body. The training sessions shall be held at least once a year. The training sessions shall include a review of the enforcement plan, possible violations, reporting methods.

 

The Enforcement Officer shall confirm that 100% of the Company’s officers/Board of Directors have participated in frontal training sessions over the year and if not, he shall arrange to make up the missing sessions towards the end of the year.

 

11.4           Implementation and assimilation of the related procedures in the enforcement plan

 

The Enforcement Officer, in collaboration with the relevant bodies (such as HR), shall map the populations that are relevant to the procedures related to the enforcement plan and determine which employees are required to participate in an assimilation process for each of the procedures (the “Mapping and Classification Process”).

 

  

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Such process shall be performed at least once a year.

 

According to the Mapping and Classification Process, the employee shall receive the procedures that are relevant to his areas of responsibility and be required to sign a document whereby he understands their content and is committed to act according thereto. After the signing by him, the direct supervisor and the Officer shall sign in confirmation and receipt of the document. The Enforcement Officer shall also monitor the employees’ aforesaid signatures of the procedures to confirm that they comply with the Mapping and Classification Process and that all of the relevant employees have signed their commitment to all of the procedures that are relevant to their functions and areas of responsibility.

 

The steering committee responsible for the implementation of the enforcement plan shall confirm that 100% of the employees have signed the procedures that were sent to them.

 

11.5           Assimilation among parties external to the Company

 

As part of his work plan, the Officer shall define parties external to the Company that are obligated to comply with the enforcement plan and/or the related procedures, and have them sign the relevant procedures to attest that they have read and understood the obligations that apply to them by virtue of the Law, the enforcement plan and the procedures.

 

Existing engagements

 

Insofar as necessary, an annex to the contract shall be added to existing engagements in which the external party undertakes to information security and prevention of misuse of inside information in particular, and to the fulfillment of any and all regulatory obligations that apply to such party, including the Improvement of Internal Enforcement Proceedings in the ISA Law in general.

 

New engagements

 

Any new engagements with an external party shall be performed after the signing by such party of a confidentiality and engagement agreements. As part of such agreements, the external party shall undertake to maintain information security, prevent misuse of inside information in particular, and in general fulfill any and all regulatory obligations that apply to such party including the Improvement of Internal Enforcement Proceedings in the ISA Law.

 

11.6           Monitoring of and reporting on the assimilation of the enforcement plan and the related procedures

 

The Officer shall examine the fulfillment of the assimilation plan and report to the relevant bodies as set forth in Chapter 4 of the enforcement plan.

 

11.7           Assimilation acts pursuant to the updating of the enforcement plan

 

Once a year and as necessary the Officer shall examine the need for updating the assimilation plan as it is presented below.

 

The plan’s update shall be approved by the steering committee in the course of a meeting that will be convened to deliberate on the matter.

 

In respect of each update of the enforcement plan, the Officer shall examine the need to inform all parties about the main changes or the full, updated enforcement plan and shall choose the best suited means of assimilation in order to communicate the changes and/or the updated enforcement plan.

 

In addition, in respect of each change the Officer shall examine the need for updating the existing assimilation plan and assimilation tools.

 

The essential elements of the assimilation plan were approved by the Audit Committee and Board of Directors as part of the approval of the enforcement plan.

 

  

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ANNEX A

 

Decisions of the Board of Directors and Audit Committee

 

Audit Committee decision from February 5, 2012:

 

“RESOLVED, that Norman Kotler, Adv., be appointed the person responsible for implementation of the Company’s Administrative Enforcement Plan.”

 

Audit Committee decision from March 21, 2012:

 

“RESOLVED, to approve the Administrative Enforcement Plan as presented to the Committee and to recommend approval of the Plan by the Board of Directors.”

 

Board of Directors decision from March 22, 2012:

 

“RESOLVED, to approve the Administrative Enforcement Plan as presented to the Board, with such non-substantive changes that may be subsequently made after further review by management and Deloitte.”

 

Board of Directors decision from November 13, 2013:

 

“RESOLVED, to ratify the appointment and authorization of the Audit Committee as the “responsible entity” for supervising the implementation of the Company’s Internal Enforcement Plan beginning November 24, 2011.”

 

41exhibit_4-35.htm

Exhibit 4.35

 

LICENSE AGREEMENT

This License Agreement (the “Agreement”) is entered into as of this 15th day of February, 2011 (the “Effective Date”), by and among BioLineRx, Ltd., a company formed pursuant to the laws of the State of Israel, having a place of business at 19 Hartum Street, P.O. Box 45158, Jerusalem, 91450, Israel (“BioLine” or “Licensee”), and Valorisation-Recherche, Limited Partnership, a limited partnership duly constituted under the laws of the Province of Quebec, having its principal place of business at 3535 Queen-Mary Road, Suite 220, Montreal, Quebec, H3V 1H8, acting through its general partner GESTION UNIVALOR, LIMITED PARTNERSHIP, a limited partnership duly constituted and having its principal place of business at the same address, itself acting by its general partner UNIVALOR INC., a corporation duly constituted and having its head office at the same address, itself represented herein by Hélène Perron, its Interim Managing Director, duly authorized for the purpose hereof as she so declares; (“Licensor”).

WHEREAS, in the course of research at the Université de Montréal (University of Montreal) (“UdeM”) the Researchers (as defined herein) developed a technology relating to Polymeric binders for celiac disease bearing reference number VAL-424-UM (as further defined below, the “Invention”);

 

WHEREAS, the rights and title to the foregoing Invention vest solely with the Licensor having been assigned to Licensor by UdeM; and

 

WHEREAS, BioLine wishes to obtain an exclusive license with respect to the Invention in order to develop and commercialize products based on the Invention, and Licensor wishes to grant BioLine such a license with respect to the Invention, all in accordance with the terms and conditions of this Agreement.

NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:

1.            Definitions.

Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 1, whether used in the singular or the plural, shall have the meanings specified below.

“Additional Ingredient” shall mean any compound or substance owned by BioLine or to which it has rights which (i) is contained in a product and (ii) when administered to a patient has a therapeutic or prophylactic clinical effect independent of a Licensed Product, either directly or by acting synergistically with or otherwise enhancing the effect of other compounds or substances contained in such product.

“Affiliate” shall mean, with respect to a party, any person, organization or entity controlling, controlled by or under common control with, such party, including, with respect to a limited partnership, its limited partners, general partners, and any person, organization or entity controlling, controlled by or under common control with, such party.  For purposes of this definition only, “control” of another person, organization or entity shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise.  Without limiting the foregoing, control shall be presumed to exist when a person, organization or entity (i) owns or directly controls 50% or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint 50% or more of the members of the governing body of the organization or other entity.  A list of all Affiliates of BioLineRx Ltd. as of the Effective Date of this Agreement is attached hereto as Exhibit A.  BioLine may, from time to time, update such list in which case it will provide notice thereof to Licensor.

 

  

  

  

“Calendar Quarter” shall mean the respective periods of 3 consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.

“Combination Product” shall mean a product, substance or device which comprises a Licensed Product and at least one Additional Ingredient.

“Commercially Reasonable Efforts” shall mean (i) with respect to any objective of development and commercialization of a Licensed Product, reasonable, diligent, good faith efforts to accomplish such objective that would normally be used in the ordinary course of business and research to accomplish a similar objective under similar circumstances by an entity comparable in size and resources to BioLine on the Effective Date; and (ii) with respect to research, development and commercialization of any Licensed Product hereunder, shall mean those efforts and resources that would be normally used by an entity comparable in size and resources to BioLine on the Effective Date for a product which is of similar market potential at a similar stage in its development or product life as such Licensed Product.

“Development Plan” shall have the meaning set out in Section 5.1.

“Exercise Notice” shall have the meaning set out in Section 2.0.

“First Commercial Sale” shall mean the first sale of a Licensed Product by BioLine, anyone on its behalf, an Affiliate of BioLine or a Sublicensee, in any form or manner, to an unaffiliated third party (those parties not regarded to as BioLine Affiliates), after Regulatory Approval has been achieved, if necessary, in the country in which such Licensed Product is sold.  Sales for test marketing, sampling and promotional uses, clinical trial purposes, compassionate or similar use shall not be considered to constitute a First Commercial Sale.

“FDA” shall mean the United States Food and Drug Administration.

“Improvements” shall mean any and all further innovations, inventions, ideas, designs, concepts, discoveries, developments, new derived material and modifications or enhancements related to or concerning the Invention and the Licensed Patents, if applicable, whether or not patentable, or otherwise protectable as trade secrets or under any other intellectual property regime, which cannot be incorporated into or exploited in relation to the development and commercialization of the Licensed Products or used in any manner without infringing one or more claims relating to the Licensed Patents, and which are brought to practice, conceived, developed or acquired after the Effective Date and prior to the termination or expiration of this Agreement.

 

  

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For the purpose of the present Agreement, Improvements shall be limited to Improvements developed, made, conceived or created by BioLine, its Affiliates and/or Sublicensees shall be referred to herein as the “BioLine Improvements”; and Improvements developed, made, conceived or created by UdeM under the direction of Jean-Christophe Leroux and assigned to Licensor shall be referred to herein as the “Licensor Improvements”.

“Invention” shall mean the invention(s) disclosed in the U.S., foreign or international patents and/or patent applications listed in Exhibit B attached hereto.

“Licensed Patents” shall mean (i) the U.S., foreign or international patent and/or patent applications set forth on Exhibit B attached hereto, (ii) all pending patent applications, including, without limitation all provisional applications, substitutions, continuations, continuations-in-part, divisions, reissues, renewals, and patents granted thereon, all patents-of-addition, reissue patents, re-examinations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof, all related to the foregoing, and (iii) any new patents to be filed (if any) regarding the Invention or Licensor Improvements, if any, which have not been patented or applied for as of the Effective Date.  Exhibit B shall include and shall be updated from time to time to reflect inclusion of new Licensed Patents.

“Licensed Product” shall mean any product that comprises, contains or incorporates, in whole or in part, the Invention and/or the Licensed Patents and/or related Improvements, if any.

“M&A Transaction” shall mean a transaction in which all or substantially all of the assets of BioLine to which the subject matter of this Agreement relates and/or all or substantially all of the assets or share capital of BioLine are acquired by or assigned to a third party.

“Net Sales” shall mean the gross amount billed or invoiced by or on behalf of BioLine and/or its Affiliates (the “Invoicing Entity”) on sales of Licensed Products or of services relating thereto (whether made before or after the First Commercial Sale of the Licensed Product), in any form or manner, to an unaffiliated third party (those parties not regarded to as BioLine Affiliates), attributable to the commercial exploitation of the Licensed Patents throughout the Territory (and not only in those territories where patent protection for the technology has been sought and/or obtained), less the following: (a) customary trade, quantity, or cash discounts to the extent actually allowed and taken; (b) amounts repaid or credited by reason of rejection or return; (c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, import, export, delivery, or use of a Licensed Product which is paid by or on behalf of the Invoicing Entity; and (d) outbound transportation, packing and delivery charges, as well as prepaid freight (including shipping insurance) actually incurred; provided, however, that

 

  

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(i) In any transfers of Licensed Products between the Invoicing Entity and an Affiliate of the Invoicing Entity not for the purpose of resale by such Affiliate, Net Sales shall be equal to the fair market value of the Licensed Products so transferred, assuming an arm’s length transaction made in the ordinary course of business; and

(ii) In the event that the Invoicing Entity, or the Affiliate of the Invoicing Entity, receives non-monetary consideration for any Licensed Products or in the case of transactions not at arm’s length with a non-Affiliate of the Invoicing Entity, Net Sales shall be calculated based on the fair market value of such consideration or transaction in relation to such Licensed Products, assuming an arm’s length transaction made in the ordinary course of business.

Sales of Licensed Products by an Invoicing Party to an Affiliate of such Invoicing Party, for resale by such Affiliate, shall not be deemed Net Sales and Net Sales shall be determined based on the total amount invoiced or billed by such Affiliate on resale to an independent third party purchaser (including but not limited to distributors, wholesalers and end-users of Products).

“Regulatory Agency” shall mean the FDA or equivalent agency or government body of another country.

“Regulatory Approval” shall mean (i) approval by the FDA permitting commercial sale of a Licensed Product, or (ii) any comparable approval permitting commercial sale of a Licensed Product granted by the applicable Regulatory Agency in any other country or jurisdiction.

“Researchers” shall mean Dr. Jean-Christophe Leroux, professor at UdeM at the time of the Invention; and M. Mohamad Nasser Eddine, post-doctoral fellow at UdeM at the time of Invention.

“Sublicense” shall mean any right granted, license given, or agreement entered into, by BioLine to or with any other person or entity, under or with respect to or permitting any use of any of the Invention, Licensed Patents or the Improvements, if any, or otherwise permitting the development, manufacture, marketing, distribution and/or sale of Licensed Products (regardless of whether such grant of rights, license given or agreement entered into is referred to or is described as a sublicense or as an agreement with respect to the development and/or manufacture and/or sale and/or distribution and/or marketing of Licensed Products).  For the avoidance of doubt, an M&A Transaction will not be regarded as a Sublicense.

“Sublicense Receipts” shall mean any payments or other consideration that BioLine or an Affiliate of BioLine or any entity on their behalf (excluding a Sublicensee) received in connection with a Sublicense, or the grant of an option to obtain a Sublicense, including without limitation royalties, license fees, milestone payments, license maintenance fees and equity; provided, however, that in the event that BioLine or an Affiliate of BioLine or any entity on their behalf (excluding a Sublicensee) receives non-monetary consideration in connection with a Sublicense or the grant of an option to obtain a Sublicense or in the case of transactions not at arm’s length, Sublicense Receipts shall be calculated based on the fair market value of such consideration or transaction, assuming an arm’s length transaction made in the ordinary course of business; and provided further, solely in the case of an arm’s length transaction, that Sublicense Receipts will be reduced by any amounts returned by BioLine or an Affiliate to a Sublicensee on account of refunds or rebates given in respect of Sublicense Receipts.

 

  

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“Sublicensee” shall mean a person or entity granted a Sublicense in accordance with Section 2.2, including any sublicensees of other Sublicensees.

“Territory” shall mean all the countries and territories of the world.

“Third Party License” shall mean a license from an unaffiliated third party (those parties not regarded as BioLine Affiliates) to one or more valid and enforceable patents issued in the United States or any other jurisdiction, the claims of which cover one or more functional components that is essential for the efficacy of the Licensed Product.  For the avoidance of doubt, a license granting rights related to an Additional Ingredient shall not be a Third Party License.

2.            License Grant and Sublicenses.

2.0.           Exercise of Right to Receive License.  Bioline shall have 60 days following the Effective Date of this Agreement to conduct its own due diligence on the Invention and the Licensed Patents. The License (as such term is defined in Section 2.1 below) shall come into force and effect upon receipt by Licensor of notice in writing from BioLine that it desires to obtain the License (the “Exercise Notice”), which Exercise Notice may be delivered to Licensor by no later than 60 days following the Effective Date of this Agreement.  Upon provision of the Exercise Notice, BioLine shall (i) provide the Licensor with the Development Plan; (ii) pay Licensor the Past Patent Fees as per Section 6.1; and (iii) pay Licensor the License Issue Fee as per Section 6.2.

2.1.           License.  Subject to the terms and conditions of this Agreement, Licensor hereby grants to BioLine an exclusive, royalty-bearing, worldwide license (the “License”) under Licensor’s rights in the Invention and the Licensed Patents to research, have researched, develop, have developed, manufacture, have manufactured, use, market, distribute, offer for sale, sell, have sold, export and import Licensed Products and/or provide services relating thereto. For purposes of this Section 2.1 and subject to Sections 2.2 and 2.3, the term “exclusive” means that Licensor shall not, during the term of this Agreement, grant such licenses or rights to any third party or engage in any of the foregoing.

2.2.           Rights Reserved.  The parties acknowledge and accept that the license granted pursuant to this Agreement is subject to the royalty free rights of UdeM and the Researchers to use the Invention and Licensed Patents solely for academic (i.e. non-commercial) research and teaching purposes, all subject to the confidentiality restrictions and publication terms imposed pursuant to this Agreement in Article 8.

2.3            No Further Grant.  This Agreement shall not be interpreted or construed as granting to BioLine any rights, express or implied, by estoppel or otherwise, to any patents, patent applications, inventions, methods, technical information, confidential information, proprietary information, expertise, know-how, trade secrets, or knowledge not specifically licensed under Section 2.1 of this Agreement; and all rights not expressly granted to BioLine by this Agreement are expressly reserved by Licensor.  BioLine acknowledges and accepts, and shall cause it Affiliates and Sublicensee to acknowledge and accept, not to contest the property, validity and the rights to use the Invention and Licensed Patents licensed by Licensor hereunder, and represents and warrants that it will not do or let anything be done which might affect the rights of Licensor in such Invention and/or Licensed Patents.  It is understood and agreed that BioLine or its Affiliates or Sublicensees will not request or obtain any such property right or right to use the Invention and/or Licensed Patents, except as otherwise stated herein.

 

  

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2.4.          Sublicenses.

2.4.1.           Sublicense Grant. BioLine shall be entitled to grant Sublicenses or other rights to third parties under the license granted pursuant to Section 2.1.  Such Sublicenses shall be made for consideration and in arm’s length transactions.  BioLine acknowledges that it shall be solely responsible for the enforcement of the terms of any Sublicense and the full and complete accomplishment by said Sublicensee of all of BioLine’s obligations in this Agreement.  For better clarity, no Sublicense agreement shall relieve BioLine or its Affiliates of any of its obligations under this Agreement, including the obligation to pay Licensor Royalties or any other amounts due pursuant to the terms and conditions of this Agreement.

2.4.2.           Sublicense Agreements.  Sublicenses shall only be granted pursuant to written agreements which shall be consistent with the terms of the present Agreement (except that the royalty rates may be different than those set forth in this Agreement).  BioLine shall provide Licensor with a copy of (i) the proposed final draft of each sublicense agreement into which it enters for Licensor’s review fifteen (15) days prior to the contemplated date of execution thereof, it being recognized that due to the nature of commercial negotiations such draft may be subject to change immediately prior to the execution thereof and BioLine may not be able to provide Licensor with such absolute final draft prior to execution, and (ii) the final executed version of each sublicense agreement into which it enters thirty (30) days of receipt of an executed draft thereof from the Sublicensee.  For avoidance of doubt, it is hereby clarified that should the final executed version include material changes from the proposed final draft provided to Licensor for review pursuant to the foregoing, BioLine shall specifically notify Licensor of such material changes prior to execution.  In addition, should any such Sublicense be written in a language other than English or French, BioLine shall provide Licensor with an English translation of the Sublicense certified in accordance with Section 13.14.  Each such sublicense agreement shall contain, inter alia, provisions to the following effect:

      2.4.2.1. All provisions necessary to ensure BioLine’s ability to perform its obligations under this Agreement, including reporting and audit requirements;

      2.4.2.2. Any Sublicense shall contain provisions confirming the reserved rights as provided in Section 2.2, and the rights of Licensor as provided in Section 2.3, and shall also include reasonable diligence obligations (as determined by BioLine having reference to the scope of the rights that are the subject of such Sublicense).

  

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      2.4.2.3. In the event of termination of the license set forth in Section 2.1 above, any existing agreements that contain a Sublicense of, or other grant of right with respect to the Invention or the Licensed Patents, shall terminate to the extent of such Sublicense or other grant of right; provided, however, that, for each Sublicensee, upon termination of the Sublicense agreement with such Sublicensee, if the Sublicensee is not then in breach of such Sublicense agreement with BioLine such that BioLine would have the right to terminate such Sublicense and that such Sublicensee desires to keep its rights to use the Invention or the Licensed Patents, subject to Sublicensee’s undertaking to indemnify Licensor as provided in Section 11 of the present Agreement, Licensor shall be obligated, at its discretion, to either (i) take over the Sublicense, or (ii) enter into a new agreement with such Sublicensee on substantially the same terms as those contained in such Sublicense agreement; and provided, further, that such terms shall be amended, if necessary, to the extent required to ensure that such Sublicense agreement does not impose any obligations or liabilities on Licensor which are not included in this Agreement.  For the avoidance of doubt, and without limiting the generality of the above, the exclusion of warranties and the limitations of representations herein stated shall be applicable to the Sublicense that would be effective between the Licensor and the Sublicensee and in no event shall Licensor be responsible or liable for any cost, payment of any kind (including for damages), act, action, obligation, collaboration or assistance if such is not expressly stated in this Agreement as being the responsibility of the Licensor.

2.4.3.           A Sublicensee shall be entitled to sublicense its rights under a Sublicense agreement, and so forth through a chain of sublicenses, provided that each such sublicense shall be subject to the terms specified in Section 2.4.1 above.

2.5.          Contractors and Affiliates.  BioLine shall have the right to utilize third party contractors or Affiliates in connection with BioLine’s activities in exploiting the license granted hereunder.  Provided that such contractors or Affiliates perform activities on BioLine’s behalf, and BioLine maintains control of and remains solely responsible for such activities, the provisions of Section 2.4 shall not apply with respect to such contractors or Affiliates.  For the avoidance of doubt, sublicenses to Affiliates of BioLine shall not be considered Sublicenses under this Agreement, provided however that (i) each such Affiliate to whom BioLine grants any rights on the Invention or on the Licensed Patents under the present Agreement shall be considered as a licensee and shall abide by the terms and conditions of the present Agreement, (ii) BioLine undertakes to diligently inform Licensor of the identity of each Affiliate that has been granted such rights and the nature and scope of such rights, and (iii) BioLine shall obtain from such Affiliate a written undertaking to abide by the terms and conditions of the present Agreement with a copy to Licensor of such undertaking.  BioLine shall be responsible for ensuring that any such Affiliate shall abide by the terms and conditions of the present Agreement.

3.            Title and Improvements.

 

3.1.           Title.  Subject to the license granted to BioLine pursuant to the terms of this Agreement and the reserved rights as provided in Section 2.2 of this Agreement, all rights, title and interest in and to the Invention and Licensed Patents are, as of the Effective Date of this Agreement, owned solely and exclusively by Licensor by way of assignment from UdeM.

 

  

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3.2.           Improvements.  The BioLine Improvements, and all intellectual property rights related thereto, shall be the sole property of BioLine, its Affiliates and/or any Sublicensees, as the case may be.  In addition, and for the avoidance of doubt, (i) the results of the activities carried out pursuant to the Development Plan or any amendments thereof, including any invention, patent, product, material, method, process, technique, know-how, data, information or other result which do not form part of the Licensed Patents, discovered in the course of or arising from the performance by BioLine, its Affiliates and/or its Sublicensees of the development work pursuant to Article 5 below, and (ii) any regulatory filing or approval, filed or obtained by BioLine, its Affiliates and/or Sublicensees in respect of the Licensed Products, shall be the sole property of BioLine, its Affiliates and/or any Sublicensees, as the case may be.

4.             Patent Filing, Prosecution and Maintenance.

 

4.1.           Filing.  BioLine shall have the first right to prepare, file, prosecute and maintain any patent applications and patents in respect of the Invention, including the Licensed Patents, at BioLine’s sole expense.  BioLine shall (i) provide Licensor with copies of material correspondence with its patent agents, (ii) notify promptly and inform Licensor of all relevant communications made between BioLine and any government patent offices in relation to the Licensed Patents, and (iii) take in consideration any comments that Licensor may have in regards to the Licensed Patents.  BioLine shall not agree to the deletion of any claims of the Licensed Patents without first consulting with the Licensor and obtaining the Licensor’s prior written consent, such consent not to be unreasonably withheld.  In any event, BioLine shall pursue its activities hereunder in good faith and agrees that it will provide all the reasonable efforts necessary to obtain and maintain patent protection of the Invention in at least the following countries: Canada, the United States, France, Italy and Belgium.  Licensor undertakes to cooperate in a timely manner with BioLine’s efforts hereunder, including by executing any documents as may be required for such purpose at BioLine’s reasonable request and full expense.

4.2.           No Warranty.  Nothing contained herein shall be deemed to be a warranty by any of the parties that they can or will be able to obtain patents on patent applications included in the Licensed Patents, or that any of the Licensed Patents will afford adequate or commercially worthwhile protection.

5.            Development Plan and Reporting.

5.1.           Diligence.  BioLine shall use Commercially Reasonable Efforts, and/or shall cause its Affiliates and/or Sublicensees to use Commercially Reasonable Efforts, to develop Licensed Products, at its or their own expense, all in accordance with the written plan and reasonable estimated timetable for the development of Licensed Products (the “Development Plan”), a copy of which is attached hereto as Exhibit C.  The Development Plan may be modified from time to time by BioLine as required in order to achieve the commercialization goals set forth above.  Notwithstanding anything to the contrary herein, BioLine itself or through its Affiliates or Sublicensees must have enrolled a first patient in Phase I study of a Regulatory Agency for a first indication no later than thirty-five (35) months from the Effective Date, and must have enrolled a first patient in Phase II study of a Regulatory Agency for a first indication no later than seventy (70) months from the Effective Date (the “Minimum Diligence”).  The Parties hereby acknowledge that the Minimum Diligence may only be amended by the written consent of all Parties.

 

  

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    5.2.          Effect of Non-diligence.  If BioLine (directly or through its Affiliates or Sublicensees) has not achieved the performance milestones set out in Exhibit C (including any revision thereof according to this Agreement) within the timelines set out for each milestone or the Minimum Diligence as provided in Section 5.1 of this Agreement (the “Diligence Default”) and this Agreement is still in force and effect, then BioLine shall pay Licensor (i) four thousand Canadian dollars (CAD $4,000) each calendar month for the first 6 calendar months following such failure date; (ii) seven thousand five hundred Canadian dollars (CAD $7,500) each calendar month for the second 6 calendar months following such failure date; and (iii) thereafter fifteen thousand Canadian dollars (CAD $15,000) each calendar month as long as such Diligence Default is not cured.

    5.3.          Progress Reports.  BioLine shall provide Licensor with quarterly progress reports which shall summarize the material activities undertaken by BioLine, its Affiliates, Sublicensees and/or contractors, as applicable, with respect to the Licensed Technology and the Development Plan and/or the Licensed Products during the period which the report covers.  Where necessary, in Licensor’s reasonable opinion, Licensor may request an update regarding BioLine’s material activities undertaken with respect to the Licensed Technology, the Development Plan or the Licensed Products, in between the provision of the aforementioned progress reports.

6.         Consideration.

 

In consideration for the grant of the license pursuant to this Agreement, BioLine shall pay the Licensor the following consideration:

6.1           Past Patent Fees.  Upon provision of the Exercise Notice, BioLine shall reimburse Licensor a portion of all past documented patents costs consisting in a lump sum amount of [*] Canadian Dollars (CAD $[*]), plus applicable taxes, a summary of which is attached hereto as Exhibit D.

6.2.          License Issue Fee.  Upon provision of the Exercise Notice, BioLine shall pay to Licensor a non-refundable license issue fee in the amount of [*] Canadian dollars (CAD $25,000).

6.3           License Maintenance Fee. BioLine shall pay to Licensor an annual non-refundable License Maintenance Fee in the amount of [*] Canadian dollars (CAD $[*]), payable commencing on the date of the first anniversary of the execution of this Agreement and annually thereafter, and fully creditable against payments on Sublicence Receipts due in accordance to Section 6.6 hereinafter for that same period.  Notwithstanding the above, no License Maintenance Fee shall be due or payable to Licensor by BioLine in any period of time during which BioLine pays to Licensor the Minimum Annual Royalties as set forth in Section 6.4.1 hereunder.

 

  

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6.4.              Royalty Payments.

    6.4.1.            Minimum Annual Royalties.  Commencing on the date of the First Commercial Sale made by BioLine, its Affiliates or Sublicensees, BioLine shall pay to Licensor a minimum annual royalty, fully creditable against Royalties due in accordance to Section 6.4.2 hereinafter, calculated as follows:

                  6.4.1.1                     [*] Canadian dollars (CAD $[*]) on January 1st following the first anniversary of the First Commercial Sale; and

                  6.4.1.2                     [*] Canadian dollars (CAD $[*]) on January 1st following the second anniversary of the First Commercial Sale, and on January 1st of every succeeding calendar year.

    6.4.2.            Royalties.  In the event that BioLine itself or any of its Affiliates or any entity on their behalf (excluding a Sublicensee) will actually manufacture and/or sell in any way or manner Licensed Products under the license, then BioLine will pay to Licensor [*] percent ([*]%) of Net Sales made in a country where there is a Licensed Patents and one and three quarter percent ([*]%) of Net Sales made in a country where there is no Licensed Patents.  Any Minimum Annual Royalties paid in accordance to Section 6.4.1 above shall be credited against any payments due in accordance to this Section 6.4.2.

6.5.           Milestone Payments.  BioLine shall make the following non-refundable milestone payments to Licensor within thirty (30) days after the first achievement of each milestone event for a Licensed Product as set forth in this Section 6.5 by BioLine or its Affiliates or Sublicensees.  Each milestone payment by BioLine to Licensor hereunder shall be payable only once, regardless of the number of times achieved by the Licensed Products:

	
Milestone Event

	
Milestone Payment

	
1.  Enrolment of the first patient in the first Phase I clinical trial relating to the Licensed Products

	
1.           All remaining past documented patents costs not already paid under Section 6.1 of this Agreement in the total amount of [*] Canadian dollars and [*] (CAD $), plus applicable taxes, a summary of which is attached hereto as Exhibit D; and

 

2.           The greater of the following amounts:

(i)             [*] Canadian dollars (CAD $[*]); or

(ii)             [*] percent ([*]%) of any milestone payment received by BioLine from Sublicense(s) in relation thereto.

 

  

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Milestone Event

	
Milestone Payment

	
2.  Enrolment of the first patient in the first Phase II clinical trial relating to the Licensed Products.

	
The greater of the following amounts:

(i)              [*]Canadian dollars (CAD $[*]); or

(ii)             [*]percent ([*]%) of any milestone payment received by BioLine from Sublicense(s) in relation thereto.

	
3.  Enrolment of the first patient in the first Phase III clinical trial relating to the Licensed Products

	
The greater of the following amounts:

(i)              [*] Canadian dollars (CAD $150,000); or

(ii)             [*] percent ([*]%) of any milestone payment received by BioLine from sublicense(s) in relation thereto.

	
4.  The first filing of a new drug application (NDA) or equivalent for the Licensed Products

	
The greater of the following amounts:

(i)              [*] Canadian dollars (CAD $[*]); or

(ii)             Twenty-two percent (22%) of any milestone payment received by BioLine from sublicense(s) in relation thereto.

	
5.  Receipt of a first regulatory approval from any relevant registration authority (e.g. FDA, TPD or EMEA) for the Licensed Products

	
The greater of the following amounts:

(i)              [*] Canadian dollars (CAD $[*]); or

(ii)             [*] percent ([*]%) of any milestone payment received by BioLine from sublicense(s) in relation thereto.

6.6.          Payments on Sublicense Receipts.  BioLine shall pay Licensor sublicense fees derived from exploitation of the license granted hereunder as follows:

6.6.1.            [*] percent ([*]%) of Sublicense Receipts prior to commencement of a Phase I study; or

6.6.2.            percent ([*]%) of Sublicense Receipts if such consideration is paid subsequent to the commencement of a Phase I study.

 

  

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6.7.           Combination Products.  Notwithstanding anything to the contrary set forth herein, in the event a Licensed Product is sold by BioLine or an Affiliate of BioLine, or any entity on their behalf (excluding a Sublicensee), in the form of a Combination Product, Net Sales from such Combination Product, for purposes of determining royalty payments, shall be determined by multiplying the actual Net Sales of such Combination Product during the applicable royalty reporting period, by the fraction A/(A+B) where: “A” is the average sale price of the Licensed Product contained in the Combination Product when sold separately by such entity; and “B” is the average price of the other Additional Ingredients included in the Combination Product when sold separately by its supplier, in each case during the applicable royalty reporting period or if sales of both the Licensed Product and/or other Additional Ingredients did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred.  In the event that such average sale price cannot be determined for both the Licensed Product and all other Additional Ingredients included in the Combination Product, Net Sales for the purpose of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Products by the fraction of C/(C+D) where “C” is the fair market value of the Licensed Product; and “D” is the fair market value of all other Additional Ingredients included in the Combination Product.  In such event, the parties shall negotiate in good faith to arrive at a determination of the respective fair market values of the Licensed Product and all other Additional Ingredients included in the Combination Product.

6.8.           Third Party Payments.  If, at any time, BioLine or an Affiliate of BioLine as provided in Section 2.5 of this Agreement or any entity on their behalf (including a Sublicensee) is required to pay commercially reasonable royalties or similar payments to one or more third parties for a Third Party License (the “Third Party Payments”), the royalties and payments on Sublicense Receipts payable to Licensor shall be reduced by the amount of such payments to such third parties; provided, however, that the royalties and payments on Sublicense Receipts payable to Licensor shall, in no event, be reduced by more than 50% of the royalties and payments on Sublicense Receipts, as the case may be, that would have been paid to Licensor if no deduction of payments for a Third Party License had be made.  In the event that the Sublicense Receipts received by BioLine already include a deduction of Third Party Payments, no deduction related to Third Party Payments shall be applied by BioLine to the payments on Sublicense Receipts payable to Licensor.

7.            Reports; Payments; Records.

7.1.          Reports and Payments.

7.1.1.      Reports.  Within sixty (60) days after the conclusion of each Calendar Quarter commencing with the first Calendar Quarter in which BioLine or an Affiliate of BioLine first receives Net Sales or Sublicense Receipts, as the case may be, BioLine shall deliver to Licensor a report containing the following information:

(a)           the number of units of Licensed Products sold by BioLine or any party acting on its behalf and/or its Affiliates in each country for the applicable Calendar Quarter;

(b)           the gross amount billed or invoiced for the Licensed Product sold by BioLine or any party acting on its behalf and its Affiliates in each country during the applicable Calendar Quarter;

(c)           a calculation of Net Sales for the applicable Calendar Quarter in each country, including a listing of applicable deductions;

 

  

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(d)           a calculation of any Sublicense Receipts for the applicable Calendar Quarter;

(e)           the total amount payable to Licensor in Canadian dollars on Net Sales and on Sublicense Receipts for the applicable Calendar Quarter, together with the exchange rates used for conversion; and

(f)           notice of any deductions arising from obligations to make payments to third parties in respect of a Third Party License pursuant to Section 6.8.

The report shall state if no amounts are due to Licensor for any Calendar Quarter.

7.1.2.           Payment.  Concurrent with the delivery of each report delivered pursuant to Section 7.1.1, BioLine shall remit to Licensor all amounts due pursuant to Section 6 for the applicable Calendar Quarter.

7.2.          Records.  BioLine shall maintain, and shall cause anyone acting on its behalf, its Affiliates and Sublicensees to maintain, complete and accurate records of Licensed Products that are made, used, marketed or sold under this Agreement, any amounts payable to Licensor in relation to such Licensed Products and all Sublicense Receipts received by BioLine, anyone acting on its behalf and its Affiliates, which records shall contain sufficient information to permit the Licensor to confirm the accuracy of any reports or notifications delivered to Licensor under Section 7.1.  The relevant party shall retain such records relating to a given Calendar Quarter for at least five (5) years after the conclusion of that Calendar Quarter.  During such five (5) year period, Licensor shall have the right, at Licensor’s expense, to cause an independent, certified public accountant, who is bound by a suitable confidentiality arrangement with BioLine, to inspect BioLine’s or the relevant Affiliates’ records during normal business hours for the sole purpose of verifying any reports and payments delivered under this Agreement.  Such accountant shall not disclose to Licensor or any third party any information gained during the course of such inspection, except that such accountant may disclose to Licensor and BioLine information gained during the course of such inspection relating to the accuracy of reports and payments delivered under this Agreement.  In addition, Licensor may request that BioLine, through an independent, certified public accountant, inspect during normal business hours the books of account, records and other relevant documentation of anyone acting on its behalf or any Sublicensees, to the extent relevant or necessary for the sole purpose of verifying the accuracy of reports and payments delivered under this Agreement. The parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of the audit.  In the event that any audit performed under this Section 7.2 reveals an underpayment in excess of five percent (5%) in any calendar year, BioLine (on behalf of the audited Affiliates of BioLine) shall bear the full cost of such audit.  Licensor may exercise its rights under this Section 7.2 only once every year and only with reasonable prior notice to BioLine.  BioLine shall cause its Affiliates and Sublicensees to comply with the terms of this Section 7.2.

7.3.           Report.  BioLine shall furnish Licensor, and shall cause its Affiliates who make, use, market or sell Licensed Products to furnish Licensor, within ninety (90) days after the end of each calendar year, commencing at the end of the calendar year of the First Commercial Sale, with a report, relating to royalties and other payments due to Licensor pursuant to this Agreement in respect to the previous calendar year and containing the same details as those specified in Section 7.1 in respect to the previous calendar year.

 

  

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7.4.           Payment Method, Currency and Interest.  Each payment due to Licensor under this Agreement shall be made by wire transfer of funds to Licensor’s accounts in accordance with written instructions provided by Licensor.  BioLine shall make payment of amounts due to Licensor under this Agreement in Canadian Dollars.  If any payment amount due to BioLine is derived from a currency other than Canadian dollars, said amount will be converted into Canadian dollars using the daily spot rate for that currency as quoted by the Bank of Canada on the last business day of the Royalty Period in respect of which the Royalties are due.  Any amount due to Licensor under this Agreement and made to Licensor more than thirty (30) days after the delay stipulated herein for its payment shall bear interest at a yearly interest rate of twelve percent (12%) calculated daily and compounded on a monthly basis.

 

7.5.          Taxes.

7.5.1.           The parties acknowledge that based on their mutual understanding as of the Effective Date current Canadian tax laws do not require the payment of any value added or consumption taxes on amounts paid by BioLine to Licensor hereunder.  In the event of any changes in such tax laws, administrative interpretations or treaties that may change current rules as applicable to such payments, BioLine shall be responsible for the payment of any such taxes to the appropriate tax authority.

7.5.2.           If applicable laws require that taxes be withheld from any amounts due to Licensor under this Agreement, BioLine shall (a) deduct these taxes from the remittable amount, (b) pay the taxes to the proper taxing authority, and (c) promptly deliver to Licensor a statement including the amount of tax withheld and justification therefore, and such other information as may be necessary for tax credit purposes.  In the event that Licensor may be exempt from or may obtain a reduction of any applicable withholding taxes, BioLine shall reasonably collaborate and assist Licensor in order to allow Licensor to benefit from such exemption or reduction of such withholding taxes.

8.             Confidential Information

8.1           Confidentiality.

 

8.1.1.           Licensor Confidential Information.  BioLine agrees that, without the prior written consent of Licensor, in each case, during the term of this Agreement and for  five (5) years thereafter, it will keep confidential, and not disclose or use Licensor Confidential Information (as defined below) other than for the purposes of this Agreement.  BioLine shall treat such Licensor Confidential Information with the same degree of confidentiality as it keeps its own confidential information, but in all events no less than a reasonable degree of confidentiality.  BioLine may disclose the Licensor Confidential Information only (a) to employees and consultants of BioLine or of its Affiliates or Sublicensees who have a “need to know” such information in order to enable BioLine to exercise its rights or fulfill its obligations under this Agreement and are legally bound by agreements which impose confidentiality and non-use obligations substantially comparable to those set forth in this Agreement, and (b) to actual and potential business partners, collaborators, investors, contractors, service providers and consultants, provided, however, in each case, that such recipient of Confidential Information first enters into a legally binding agreement with BioLine which imposes confidentiality and non-use obligations with respect to Confidential Information substantially comparable to those set forth in this Agreement and has a minimum term of five (5) years from date of signature of the binding agreement.  For purposes of this Agreement, “Licensor Confidential Information” means any research, academic, scientific, technical, trade or business information relating to the subject matter of this Agreement designated as confidential or which otherwise should reasonably be construed under the circumstances as being confidential disclosed by or on behalf of the Licensor or any of its employees, consultants (including employees or consultants of its general or limited partners) or UdeM’s employees, researchers (including the Researchers) or students, to BioLine, whether in oral, written, graphic or machine-readable form, except to the extent such information: (i) was known to BioLine at the time it was disclosed, other than by previous disclosure by or on behalf of the Licensor, as evidenced by BioLine’s written records at the time of disclosure; (ii) is at the time of disclosure or later becomes publicly known under circumstances involving no breach of this Agreement, as evidenced by BioLine’s written records at the time of disclosure; (iii) is lawfully and in good faith made available to BioLine by a third party who is not subject to obligations of confidentiality to the Licensor with respect to such information, as evidenced by BioLine’s written records at the time of disclosure; or (iv) is independently developed by BioLine without the use of or reference to the Licensor Confidential Information, as demonstrated by documentary evidence.

 

  

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                8.1.2.            BioLine Confidential Information.  Licensor agrees that, without the prior written consent of BioLine, in each case, during the term of this Agreement and for five (5) years thereafter, it will keep confidential, and not disclose or use BioLine Confidential Information (as defined below) other than for the purposes of this Agreement.  Licensor shall treat such BioLine Confidential Information with the same degree of confidentiality as it keeps its own confidential information, but in all events no less than a reasonable degree of confidentiality.  Licensor may disclose the BioLine Confidential Information only to employees and consultants of Licensor or of its Affiliates who have a “need to know” such information in order to enable Licensor to exercise its rights or fulfill its obligations under this Agreement and are legally bound by agreements which impose confidentiality and non-use obligations substantially comparable to those set forth in this Agreement.  For purposes of this Agreement, “BioLine Confidential Information” means any research, scientific, technical, trade or business information relating to the subject matter of this Agreement designated as confidential or which otherwise should reasonably be construed under the circumstances as being confidential disclosed by or on behalf of BioLine pursuant to this Agreement, whether in oral, written, graphic or machine-readable form, except to the extent such information: (i) was known to Licensor at the time it was disclosed, other than by previous disclosure by or on behalf of BioLine as evidenced by Licensor’s written records at the time of disclosure; (ii) is at the time of disclosure or later becomes publicly known under circumstances involving no breach of this Agreement, as evidenced by Licensor’s written records at the time of disclosure; (iii) is lawfully and in good faith made available to Licensor by a third party who is not subject to obligations of confidentiality to BioLine with respect to such information, as evidenced by Licensor’s written records at the time of disclosure; or (iv) is independently developed by Licensor without the use of or reference to the BioLine Confidential Information, as demonstrated by documentary evidence.

 

  

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8.2.          Disclosure of Agreement. Each party may disclose non-commercial or non-confidential terms of this Agreement to the extent required, in the reasonable opinion of such party’s legal counsel, to comply with applicable laws, as well as to Sublicensees and prospective and current investors, pursuant to appropriate non-disclosure arrangements.  If a party discloses this Agreement or any of the terms hereof in accordance with this Section 8.2, such party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other party.  Notwithstanding the above, each party may disclose commercial or confidential terms of this Agreement, as necessary or required under applicable laws and regulations, including Israeli and Canadian and other applicable securities laws and the regulations of the Tel-Aviv Stock Exchange or the Toronto Stock Exchange and other applicable exchanges and, in any such events, shall promptly advise the other party thereof.  Licensor may disclose the commercial terms of this Agreement to UdeM and the Researchers only to the extent required to establish the monetary returns to be distributed to UdeM and the Researchers.

 

8.3.          Publicity.  Without derogating from Section 8.2 and Section 8.4, either party may make announcements, publications, presentations and similar disclosures (i) relating to the general subject matter of this Agreement, (ii) in connection with the marketing or sale of any Licensed Products, or (iii) in respect of the progress of the exercise of the license granted hereunder without the approval of the other party, provided, however, that in so doing the party does not disclose any of the other party’s Confidential Information, (as defined above), or the commercial terms of this Agreement without having obtained the prior written consent of the other party.  Except as provided in the immediately preceding sentence, no party will make any public announcement regarding this Agreement without the prior written approval of the other party.

 

8.4           Publications.

 

    8.4.1.            Except for UdeM’s students’ master or doctorate theses, Licensor shall ensure that no publications in writing, in scientific journals or otherwise, or presentations or other oral disclosures at scientific conventions relating to the Development Plan or the Licensor Improvements and which are subject to the terms and conditions of this Agreement, are published or presented, as the case may be, by it or by the Researchers, or at the Researchers’ direction, without the prior written consent of BioLine, which consent shall not be unreasonably withheld.

 

    8.4.2.           The Licensor shall provide BioLine with a written copy of the material to be so submitted or presented, and shall allow BioLine to review such submission to determine whether the publication or presentation contains subject matter for which patent protection should be sought prior to publication or presentation.  BioLine undertakes to reply in writing to any such request for consent by the Licensor within 30 days of application.  If no response is made within this period, such consent shall be deemed to be granted.

 

  

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    8.4.3.           Should BioLine decide not to allow publication or presentation as provided above, publication shall be postponed for a period of not more than 3 months from the date of submission of the request to BioLine, in order to enable the necessary patent filings to be made.  After such 3 months period, the Researchers shall be free to publish or present the postponed publication in any manner they see fit.

 

9.             Patent Infringement.

 

9.1           Enforcement of Licensed Patents.

 

9.1.1.           Notice.  In the event any party becomes aware of any possible or actual infringement or unauthorized possession, knowledge or use of any Licensed Patents by a third-party (collectively, an “Infringement”), that party shall promptly notify the other party and provide it with details in its possession regarding such Infringement.

 

9.1.2.           Suit by BioLine.  BioLine shall have the right, but not the obligation, to take action in the prosecution, prevention, or termination of any Infringement.  Should BioLine elect to bring suit against an infringer and Licensor is joined as party plaintiff in any such suit, Licensor shall have the right to approve the counsel selected by BioLine to represent BioLine and Licensor, such approval not to be unreasonably withheld.  The expenses of such suit or suits that BioLine elects to bring, including any expenses of Licensor incurred in conjunction with the prosecution of such suits or the settlement thereof, shall be paid for entirely by BioLine and BioLine shall hold Licensor free, clear and harmless from and against any and all costs of such litigation, including reasonable attorneys’ fees.  BioLine shall not compromise or settle such litigation without the prior written consent of Licensor, which consent shall not be unreasonably withheld or delayed.  In the event BioLine exercises its right to sue pursuant to this Section 9.1.2, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys’ fees, necessarily involved in the prosecution of any such suit.  If, after such reimbursement, any funds shall remain from said recovery, then Licensor shall receive an amount equal to twenty-five percent (25%) of such funds and the remaining seventy-five percent (75%) of such funds shall be retained by BioLine.

 

9.1.3.           Suit by Licensor. If BioLine does not take action in the prosecution, prevention, or termination of any Infringement pursuant to Section 9.1.2 above, and has not commenced negotiations with the infringer for the discontinuance of said Infringement, within ninety (90) days after receipt of notice to BioLine by Licensor of the existence of an Infringement, Licensor may elect, at its sole and complete discretion, to do so.  Should Licensor elect to bring suit against an infringer and BioLine is joined as party plaintiff in any such suit, BioLine shall have the right to approve the counsel selected by Licensor to represent Licensor and BioLine, such approval not to be unreasonably withheld.  The expenses of such suit or suits that Licensor elects to bring, including any expenses of BioLine incurred in conjunction with the prosecution of such suits or the settlement thereof, shall be paid for entirely by Licensor and Licensor shall hold BioLine free, clear and harmless from and against any and all costs of such litigation, including reasonable attorneys’ fees.  Licensor shall not compromise or settle such litigation without the prior written consent of BioLine, which consent shall not be unreasonably withheld or delayed.  In the event Licensor exercises its right to sue pursuant to this Section 9.1.3, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys’ fees, necessarily involved in the prosecution of any such suit.  If, after such reimbursement, any funds shall remain from said recovery, then BioLine shall receive an amount equal to twenty-five percent (25%) of such funds and the remaining seventy-five percent (75%) of such funds shall be retained by Licensor.

 

  

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9.1.4.           Own Counsel.  Each party shall always have the right to be represented by counsel of its own selection and at its own expense in any suit instituted under this Section 9 by the other party for Infringement.

 

9.1.5.           Cooperation.  Each party agrees to cooperate fully in any action under this Section 9 which is controlled by the other party, provided that the controlling party reimburses the cooperating party promptly for any reasonable costs and expenses incurred by the cooperating party in connection with providing such assistance.

 

9.1.6.           Standing.  If a party lacks standing and the other party has standing to bring any such suit, action or proceeding, then such other party (the “Requested Party”) shall do so at the request of and at the full costs and expenses of the requesting party (the “Requesting Party”).  The Requesting Party shall pay in advance to the Requested Party any and all anticipated costs of such suit, action or proceeding, including attorneys’ fees and shall hold the Requested Party free, clear and harmless from and against any and all costs resulting from such litigation.  If a party determines, (the “Determining Party”), that it is necessary for the other party (the “Determined Party”), to join any such suit, action or proceeding, the Determined Party shall execute all papers and perform such other acts as may be reasonably required in the circumstances at the full costs and expenses of the Determining Party.  The Determining Party shall pay in advance to the Determined Party any and all anticipated costs of such joining of any such suit, action or proceeding, including attorneys’ fees and shall hold the Determined Party free, clear and harmless from and against any and all costs resulting from such litigation.

 

9.2           Legal Action against a Party.  Each party will provide the other party with prompt written notice detailing as many facts as possible concerning any claim, threat, action, suit or proceeding brought against it (including Affiliates or Sublicensees), alleging the infringement of the intellectual property rights of a third party by reason of the discovery, development, manufacture, use, sale, importation, or offer for sale of a Licensed Product or otherwise due to the use or practice of the Invention and Licensed Patents or a claim challenging the validity or ownership of the Licensed Patents.  The parties shall consult with each other in good faith to decide what action, if any, should be taken in respect of such third-party claim.

 

10.           Representations and Warranties; Limitation of Liability.

10.1.        Representations of Licensor.  Licensor hereby represents and warrants to BioLine that, (i) to the best of its knowledge, by virtue of assignment from UdeM, it has sole and exclusive ownership of the Licensed Patents and/or patent applications listed in Exhibit B attached hereto; (ii) no rights in or to the Invention and/or the Licensed Patents have been granted to a third party that are in force and valid as of the Effective Date and that are inconsistent with the rights granted to BioLine under this Agreement; (iii) to the best of its knowledge, it has the right to grant the license granted under this Agreement free and clear of liens, encumbrances and security interests and, to its best knowledge, third party claims; (iv) it will not transfer, assign, grant rights to, sell, lease or otherwise dispose of or encumber the Invention and/or the Licensed Patents other than as may be expressly permitted herein; and (v) it has not been notified of any legal claims, demands, threats or proceeding in writing or otherwise of any sort by any third party against the Licensor contesting the ownership or validity of the Invention and/or any of the Licensed Patents, or claiming that the practice of the Invention and/or any of the Licensed Patents in the manner contemplated by this Agreement would infringe the rights of such third party and, to the best of our knowledge without having conducted a complete due diligence on the matter, nor any reason to expect the same.

 

  

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10.2.           Undertakings of BioLine.  BioLine undertakes that it will, and shall cause any third party that acts on its behalf or an Affiliate that is granted rights to the Invention or Licensed Patents as provided pursuant to this Agreement to (i) respect all of its obligations found herein or in any other agreement with Licensor; and (ii) not, directly or indirectly, engage in any activities concerning the Licensed Patents which is contrary to applicable laws.

10.3.           Joint Representations and Warranties.  Licensor hereby represents and warrants to BioLine, and BioLine hereby represents and warrants to the Licensor, that it has full power and authority to enter into and perform its obligations pursuant to this Agreement and to consummate the transactions contemplated herein and that the individual signing this Agreement on its behalf below has the authority to do so and to bind that party to the terms of this Agreement.

10.4.           Compliance with Law and Assumption of Costs.  BioLine undertakes that it will comply, and shall require that any parties acting on its behalf and its Affiliates and Sublicensees comply, with applicable laws and regulations and in full respect of accepted ethical principles relating to the development, manufacture, use, sale, or any other disposition of Licensed Products.  The Parties recognize that all costs related to any developments, clinical trials, regulatory approvals and commercialization of the Invention and the Licensed Patents shall be the full responsibility of BioLine.  BioLine may, at its sole and complete discretion, transfer to its Affiliates or its Sublicensees such costs or part thereof.

10.5.           No Warranty.  Except as otherwise expressly provided in this Agreement, neither party makes any warranty with respect to any technology, patents, goods, services, rights or other subject matter of this Agreement, and each party hereby disclaims warranties of merchantability, fitness for a particular purpose and non-infringement with respect to any and all of the foregoing.

10.6.           Patentability, validity and scope of Licensed Patents.  Licensor does not make any warranties or representations, express or implied, concerning the validity and patentability of the Invention, Licensed Patents, the intellectual property rights related thereto, the Licensed Products or whether or not the exercise of the rights licensed under this Agreement will result in the infringement of any intellectual property right held by third parties.  BioLine acknowledges that it has been advised by Licensor to undertake its own due diligence with respect to the Invention and the Licensed Patents.

10.7.           No Warranty of Merchantability of Licensed Patents.  Licensor makes no warranties, express, implied or statutory, and assume no liabilities or responsibilities with respect to (i) the use, sale or other disposition by BioLine, its Affiliates, Sublicensees, vendees or transferees of Licensed Products using the Licensed Patents, or (ii) any representations or warranties that BioLine or its Affiliates may extend.  Licensor does not warrant that the underlying technology described in or claimed as inventions in any of the Licensed Patents is error free or that it will meet BioLine’s requirements.  All implied warranties of merchantability and fitness for a particular purpose are expressly disclaimed and excluded.  The entire risk as to the results and performance of the underlying technology described in or claimed as an invention in any of the Licensed Patents and any Licensed Products, services or methods based on the underlying technology described in or claimed as an invention in any of the Licensed Patents is assumed by BioLine.

 

  

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10.8.        Limitation of Liability.  Notwithstanding anything else in this Agreement or otherwise, neither Licensor nor BioLine will be liable to the other with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for (i) any indirect, incidental, consequential or punitive damages or lost profits or (ii) cost of procurement of substitute goods, technology or services, even if advised of the possibility of such liabilities; provided, however, that the exclusion of (i) above shall not apply to BioLine’s indemnity obligation set out in Section 11.1, provided, further, that BioLine’s maximum exposure for the damages set out in (i) above shall be limited to a maximum of CDN $2,500,000.

11.           Indemnification.

11.1.       Indemnity.  BioLine shall indemnify, defend, and hold harmless Licensor, its limited and general partners and their respective directors, officers, employees and agents and their respective successors, heirs and assigns (the “Licensor Indemnitees”), against any and all liability, damage, loss, or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon any of the Licensor Indemnitees in connection with any claims, suits, actions, demands or judgments (“Claims”) arising out of any theory of liability (including without limitation actions in the form of tort, warranty, or strict liability and regardless of whether such action has any factual basis) concerning: (i) the use of the Invention and Licensed Patents by BioLine or any party acting on its behalf, on its behalf or any of its Affiliates or Sublicensees, or concerning any Licensed Product, process, or service that is developed, made, used, manufactured, promoted, sold or otherwise disposed of pursuant to any right or license granted by Licensor to BioLine under this Agreement (except in cases where, and to the extent that, such Claims result from the gross negligence or willful misconduct on the part of Licensor , in which case Licensor shall indemnify BioLine and the provisions hereof shall apply mutatis mutandis); and (ii) the gross negligence or willful misconduct by BioLine or any party acting on its behalf, or any of its Affiliates or Sublicensees.

11.2.       Procedures.  If Licensor receives notice of any Claim, Licensor shall, as promptly as is reasonably possible, give BioLine notice of such Claim; provided, however, that failure to give such notice promptly shall only relieve BioLine of any indemnification obligation it may have hereunder to the extent such failure diminishes the ability of BioLine to respond to or to defend the Licensor Indemnitee against such Claim.  Licensor and BioLine shall consult and cooperate with each other regarding the response to and the defense of any such Claim and BioLine shall, upon its acknowledgment in writing of its obligation to indemnify the Licensor Indemnitee, be entitled to and shall assume the defense or represent the interests of the Licensor Indemnitee in respect of such Claim, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Licensor Indemnitee and to propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no such settlement shall be made without the written consent of the Licensor, such consent not to be unreasonably withheld.  Nothing herein shall prevent the Licensor from retaining its own counsel and participating in its own defense at its own cost and expense.

 

  

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11.3.       Insurance.  BioLine shall maintain insurance that is reasonably adequate to fulfill any potential obligation to the Licensor Indemnitees consistent with industry standards.  BioLine shall provide Licensor, upon request, with written evidence of such insurance.

12.           Term and Termination.

12.1.       Term.  The term of this Agreement shall commence on the Effective Date and, unless earlier terminated as provided in this Section 12, shall continue in full force and effect and shall expire upon the later of the expiration of the last valid patent claim in or covered by any patent application related to any of the Invention, the Improvements, the Licensed Patents or any other patent pertaining to the Invention or the Improvements, whichever expires last.

 

12.2.       Effect of Expiration.  Following the expiration of this Agreement pursuant to Section 12.1 (and provided the Agreement has not been earlier terminated pursuant to Section 12.3, in which case Section 12.4.1 shall apply), BioLine shall have a royalty-bearing, non-exclusive, worldwide license (with the right to grant Sublicenses) under the same terms stated above in Sections 2, 6.4.2 and 6.6  under Licensor’s rights in the Invention to research, have researched, develop, have developed, manufacture, have manufactured, use, market, distribute, have distributed, offer for sale, sell, have sold, export and import Licensed Products and/or provide services relating thereto.  In addition, following any expiration as aforesaid, each party will return to the other party, or destroy or have destroyed any Confidential Information of the other party, except that each party may retain one secure archival copy thereof as may be required by applicable law.

 

12.3.       Termination.

 

12.3.0.         Automatic Nullity.  Except for the terms of this Section 12.3.0, this Agreement shall be null and void as if it was never signed in the event that BioLine does not deliver the Exercise Notice to Licensor within the time period specified in Section 2.0. In such event, each Party hereby gives to the other Party a complete release and discharge in relation to the subject matter of this Agreement, except that the parties shall remain bound by the terms and conditions set forth in the Non-Disclosure and Non Use Agreement dated August 27th, 2010.

 

12.3.1.          Termination without Cause.  BioLine may terminate this Agreement upon thirty (30) days prior written notice to Licensor.

 

12.3.2.         Termination for Default.

 

  

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     12.3.2.1. In the event that BioLine commits a material breach of its obligations under this Agreement and fails to cure that breach within sixty (60) days after receiving written notice thereof from Licensor, Licensor may terminate this Agreement immediately upon written notice to BioLine.  Notwithstanding the foregoing, in the event that any breach is not susceptible of cure within the stated period and BioLine diligently informs the Licensor in writing of such and uses diligent good faith efforts to cure such breach, the stated period will be extended by an additional thirty (30) days.

 

      12.3.2.2. In the event that Licensor commits a material breach of its obligations under this Agreement and fails to cure that breach within sixty (60) days after receiving written notice thereof from BioLine, BioLine may terminate this Agreement immediately upon written notice to Licensor.  Notwithstanding the foregoing, in the event that any breach is not susceptible of cure within the stated period and Licensor diligently informs BioLine in writing of such and uses diligent good faith efforts to cure such breach, the stated period will be extended by an additional thirty (30) days.

 

12.3.3.         Bankruptcy.

      12.3.3.1.  Either BioLine or Licensor may terminate this Agreement upon notice to the other if the other party becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by reason of its insolvency, or in the event an involuntary bankruptcy action is filed against the other party and not dismissed within ninety (90) days, or if the other party becomes the subject of liquidation or dissolution proceedings or otherwise discontinues business.

      12.3.3.2.  Notwithstanding the foregoing, in the event a receiver or trustee (or the like) is appointed or either party has entered into a settlement with its creditors and the other party is otherwise meeting its obligations pursuant to this Agreement, and such trustee (or the like) or creditors assume all the obligations set forth in this Agreement, this Agreement may not be terminated as contemplated under Section 12.3.3.1 during such period as long as it is not breached in any way or manner.

12.4.       Effect of Termination.

12.4.1.Termination of Rights.  Upon termination by BioLine pursuant to Section 12.3.1, 12.3.2 or 12.3.3 hereof (except in the circumstances set out in Section 12.3.3.2), or by Licensor pursuant to Sections 12.3.2 or 12.3.3 hereof (except in the circumstances set out in Section 12.3.3.2): (a) the rights and licenses granted to BioLine under Section 2 shall terminate; (b) all rights in and to the Invention and License Patents shall revert to Licensor and BioLine and its Affiliates shall not be entitled to make any further use whatsoever of the Invention and Licensed Patents nor shall BioLine research, develop, manufacture, use, market, distribute, offer for sale, sell, export or import Licensed Products and/or provide services relating thereto; and (c) with respect to any Sublicense, such Sublicense shall terminate unless such Sublicensee desires to keep its rights to use the Invention and the Licensed Patents, in which case – subject to the Sublicensee’s undertaking to indemnify Licensor as provided in Section 11 of the present Agreement – Licensor shall be obligated, at its discretion, to either (i) take over the Sublicense, or (ii) to enter into a new agreement with such Sublicensee on substantially the same terms as those contained in such Sublicense agreement; and provided, further, that such terms shall be amended, if necessary, to the extent required to ensure that such Sublicense agreement does not impose any obligations or liabilities on Licensor which are not included in this Agreement.  For the avoidance of doubt, and without limiting the generality of the above, the exclusion of warranties and the limitations of representations herein stated shall be applicable to the Sublicense that would be effective between the Licensor and the Sublicensee and in no event shall Licensor be responsible or liable for any cost, payment of any kind (including for damages), act, action, obligation, collaboration or assistance if such is not expressly stated in this Agreement as being the responsibility of the Licensor.  In addition, following any termination as aforesaid, each party will return to the other party, or destroy or have destroyed any Confidential Information of the other party, except that each party may retain one secure archival copy thereof as may be required by applicable law; and BioLine or any party acting on its behalf or any of its Affiliates of its Sublicensees (subject to the foregoing arrangements) shall discontinue any manufacture, distribution or use of the Invention and Licensed Patents, including in relation to the Licensed Product.

 

  

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12.4.2.            Rights on BioLine Improvements.  In the event that this Agreement is terminated by Licensor pursuant to Sections 12.3.2.1 or 12.3.3, or by BioLine pursuant to Section 12.3.1, Licensor, at its discretion and upon written request and subject to undertaking to pay BioLine fifteen percent (15%) of any Net Proceeds (as defined below) actually received by Licensor or Licensor’s designate or assignee from the commercialization of the BioLine Improvements, shall have an exclusive (subject to the rights herein granted to UdeM), transferable, worldwide and unlimited license, with the right to grant sub-licenses, to use and exploit the BioLine Improvements in the Territory solely for use in connection with the Licensed Technology.  BioLine shall also grant UdeM an unlimited, perpetual and royalty-free right to use the BioLine Improvements for academic (i.e. non-commercial) research and teaching purposes only, conditional to confidentiality restrictions consistent with the terms of this Agreement.  Licensor shall pay to BioLine amounts, if any, payable under this Section 12.4.2, within ninety (90) days of receipt of the relevant Net Proceeds.

For the purpose of this section, the term “Net Proceeds” means royalties or license fees actually received by Licensor or Licensor’s designate or any assignee in respect of such license with a third party after deduction of all costs, fees and expenses actually incurred by Licensor in connection with such license (including, without limitation, patent costs, and all attorneys’ fees and expenses and other costs and expenses in connection with the negotiation and conclusion of such license).

12.4.3.            Accruing Obligations. Termination of this Agreement shall not relieve the parties of obligations occurring prior to such termination, including obligations to pay amounts accruing hereunder up to the date of termination.

12.5.        Survival.  The parties’ respective rights, obligations and duties under Sections 8, 10, 11, 12.2, 12.4, 13.2, 13.3, 13.4 and 13.14, as well as any rights, obligations and duties which by their nature extend beyond the expiration or termination of this Agreement, shall survive any expiration or termination of this Agreement including any obligation to pay any fees due to Licensor, arising from the provisions of this Agreement, and being received following termination or expiration.

 

  

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13.          Miscellaneous.

13.1.        Entire Agreement.  This Agreement is the sole agreement with respect to the subject matter hereof and except as expressly set forth herein, supersedes all other agreements and understandings between the parties with respect to same.

13.2.        Notices.  Unless otherwise specifically provided, all notices required or permitted by this Agreement shall be in writing and may be delivered personally, or may be sent by facsimile or certified mail, return receipt requested, to the following addresses, unless the parties are subsequently notified of any change of address in accordance with this Section 13.2:

	
If to BioLine:

	
BioLineRx, Ltd.

19 Hartum Street

P.O. Box 45158

Jerusalem  91450

Israel

Attention:  Chief Financial Officer

Fax:  +972-2-548-9101

 

	
With a copy (which shall not constitute notice) to:

	
Yigal Arnon & Co., Law Offices

22 Rivlin Street

Jerusalem, 94263

Israel

Attention:  Barry Levenfeld, Adv.

Fax:  +972-2-623-9236

	
If to the Licensor:

	
 

Valorisation-Recherche, Limited Partnership

 

Civic address:

3535, Queen-Mary Road, suite 220

Montréal (Québec) H3V 1H8

 

Postal address :

P.O. Box 6079, Station Centre-ville

Montréal (Québec) H3C 3A7

 

Attention: Hélène Perron, Interim Managing-Director

Fax: (514) 340-3204

Any notice shall be deemed to have been received as follows: (i) by personal delivery, upon receipt; (ii) by facsimile or email, receipt confirmed, one (1) business day after transmission or dispatch; (iii) by airmail, three (3) business days after delivery to the postal authorities by the party serving notice.

 

  

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13.3.           Governing Law and Jurisdiction.  This Agreement shall be governed by and construed in accordance with the laws of the Province of Ontario, without regard to the application of principles of conflicts of law, except for matters of patent law, which, other than for matters of inventorship on patents, shall be governed by the patent laws of the relevant country of the patent.  The parties hereby consent to personal jurisdiction in the Province of Ontario and agree that any lawsuit they file to enforce their respective rights under this Agreement shall be brought in the competent court in Toronto, Ontario.

 

13.4.           Binding Effect.  This Agreement shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns.

 

13.5.           Headings.  Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.

 

13.6.           Counterparts.  This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original.

 

13.7.           Amendment; Waiver.  This Agreement may be amended, modified, superseded or canceled, and any of the terms may be waived, only by a written instrument executed by each party or, in the case of waiver, by the party waiving compliance.  The delay or failure of any party at any time or times to require performance of any provisions hereof shall in no manner affect the rights at a later time to enforce the same.  No waiver by either party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.

 

13.8.           No Agency or Partnership.  Nothing contained in this Agreement shall give any party the right to bind another, or be deemed to constitute either party as agents for each other or as partners with each other.

 

13.9.           Assignment and Successors.  This Agreement may not be assigned by either party, without the consent of the other, which consent shall not be unreasonably withheld, except that each party may, without such consent, assign this Agreement and the rights, obligations and interests of such party, in whole or in part, to any of its Affiliates, to any purchaser of all or substantially all of its assets or research to which the subject matter of this Agreement relates, or to any successor corporation resulting from any merger or consolidation of such party with or into such corporation.

 

13.10.           Force Majeure.  Neither party will be responsible for delays resulting from causes beyond the reasonable control of such party, including without limitation, regulatory delay, fire, explosion, flood, war, strike, or riot, provided that the non-performing party uses commercially reasonable efforts to avoid or remove such causes of non-performance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

13.11.           Interpretation.  The parties hereto acknowledge and agree that: (i) each party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to both parties hereto and not in favor of or against either party, regardless of which party was generally responsible for the preparation of this Agreement.

 

  

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13.12.           Severability.  If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected.

13.14.           Language.  The parties hereto confirm that it is their wish that this Agreement be drawn up in English only.  Should any notice, document or agreement related to this Agreement be written in a language other than English, the party who is giving such notice, document or agreement shall provide the other party with an English translation, certified in writing to be a true and exact translation by a signed statement of an officer of that party, at his own cost.  Les parties aux présentes confirment leur volonté que cette convention soit rédigée en anglais seulement.  Si un avis, document ou entente relié à la présente convention était écrit dans une langue autre que l’anglais, la partie qui le produit sera tenue de fournir à l’autre partie une traduction en langue anglaise de ce document, certifiée vraie et conforme par déclaration écrite et signée d’un officier de cette partie, à ses propres frais.

[Remainder of page intentionally left blank]

 

  

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[Signature page to License Agreement]

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in two (2) originals by their duly authorized representatives as of the date first written above.

 

	
Valorisation-Recherche, Limited 

Partnership, acting through its general 

partner Gestion Univalor, limited 

partnership, itself acting through its general 

partner Univalor Inc.

 

 

By: /s/ Hélène Perron

Name: Hélène Perron

Title: Interim Managing Director

	
BioLineRx, Ltd.

 

By: /s/ Kinneret Savitsky

Name: Kinneret Savitsky

Title: CEO

 

 

By: /s/ Philip Serlin

Name: Philip Serlin

Title: Chief Financial and Operating Officer

  

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Exhibit A

 

Affiliates of BioLineRx Ltd:

	
  

	
·

	
BioLine Innovations Jerusalem, Ltd.

	
  

	
·

	
BioLine Innovations Jerusalem, Limited Partnership

	
  

	
·

	
BioLineRx USA, Inc

  

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Exhibit B

 

Patents and/or patent applications

	
PCT

	
Priority date: 14-NOV-2005 (US)

PCT No.: PCT/CA2006/001784

WIPO No.: WO/2007/053935

	
Title

	
Pharmaceutical Composition comprising Polymeric Binders with non-­hydrolysable covalent bonds and their use in treating Celiac disease

	
National Entries (Pub. nb)

	
Albania (AL)

	  
	
Australia (AU2006312953)

	  
	
Brazil (BR)

	  
	
Canada (CA2629327)

	  
	
China (CN101360505)

	  
	
Croatia (HR)

	  
	
European Union (EP1948201)

	  
	
Hong Kong (HK)

	  
	
India (IN)

	  
	
Israel (IL)

	  
	
Japan (JP2009515838)

	  
	
Mexico (MX2008006233)

	  
	
Russia Federation (RU2008123835)

	  
	
South Africa (ZA200804197)

	  
	
United States (US2008254099)

	  

 

  

29

  

 

Exhibit C

[*]

 

  

30

  

Exhibit D

[*]

 

31

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