LICENSE AGREEMENT
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
EXHIBIT 4.16
THIS LICENSE AGREEMENT (the “Agreement”) is entered into as of this 25 day of November, 2007 (the “Effective Date”), by and among BioLine Innovations Jerusalem, LP, a limited partnership formed and existing under the laws of the State of Israel, having a place of business at 00 Xxxxxx Xxxxxx, X.X. Xxx 00000, Xxxxxxxxx, 00000, Xxxxxx (“BioLine”), and Innovative Pharmaceutical Concepts (IPC) Inc., a company formed and existing under the laws of the British Virgin Islands, having a place of business at Xxxxxx Xxxxx, 0xx Xxxxx, 333 Waterfront Drive, P.O. Box 3339, Road Town, Tortola, British Virgin Islands (“Licensor”).
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:
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 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 fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity.
1
“Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so long as this Agreement is in effect.
“Combination Product” shall mean a product, substance or devise which comprises a Licensed Product and at least one Additional Ingredient.
“Commercially Reasonable Efforts” shall mean (i) with respect to any objective by an entity, reasonable, diligent, good faith efforts to accomplish such objective as other entities in the business of such entity (together with its Affiliates as a group) would normally use in the ordinary course of business and research to accomplish a similar objective under similar circumstances; and (ii) with respect to research, development and commercialization of any Licensed Product hereunder, shall mean those efforts and resources normally used by other entities in the business of such entity (together with its Affiliates as a group) for a product owned by it or to which it has rights, 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.
“Development Results” shall mean all data, summaries, analyses, reports and other results and information relating to the Licensed Technology generated by or on behalf of BioLine in the exercise of its rights and its performance under this Agreement.
“First Commercial Sale” shall mean the first sale of a Licensed Product by BioLine, an Affiliate of BioLine or a Sublicensee to an unaffiliated third party after Regulatory Approval has been achieved in the country in which such Licensed Product is sold. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.
“FDA” shall mean the United States Food and Drug Administration.
“Government Programs” shall mean the Biotech Incubators Program of the Office of the Chief Scientist of the Israeli Ministry of Industry and Trade, and any other funding programs sponsored by the Israeli or other governments.
“Grants” shall mean any funds or benefits received by BioLine from governmental, quasi-governmental or other non-profit sources for the development of Licensed Products or other benefits, including but not limited to grants provided within the context of Government Programs.
“IND” shall mean (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a Licensed Product in human subjects, or any successor application or procedure, and (ii) any comparable application filed with a Regulatory Agency in any other country or jurisdiction.
2
“Licensed Product” shall mean any product that comprises, contains or incorporates Licensed Technology.
“Licensed Technology” shall mean the Licensed Patents, and all inventions, know-how and other intellectual property owned by or licensed to Licensor related thereto.
“Licensed Patents” shall mean (i) the patents and/or patent applications set forth on Exhibit A attached hereto, (ii) all national-phase member patents and patent applications corresponding thereto, (iii) all improvements, updates, modifications and enhancements thereto made by Licensor by the Effective Date (if any), and (iv) all provisional applications, 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. Exhibit A shall include and shall be updated from time to time to reflect inclusion of new Licensed Patents.
“M&A Transaction” shall mean a transaction in which all or substantially all of the partnership interests of BioLine and/or all or substantially all of the assets or share capital of its general and/or limited partner(s) 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 (whether made before or after the First Commercial Sale of the Licensed Product), 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; (d) payment to one or more third parties to obtain a Third Party License from such third party(ies) in order to practice the Licensed Technology; and (e) outbound transportation, packing and delivery charges, as well as prepaid freight (including shipping insurance) actually incurred; provided, however, that:
(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, assuming an arm’s length transaction made in the ordinary course of business.
3
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.
“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.
“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 Licensed Technology (or any part thereof) 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).
“Sublicense Receipts” shall mean any payments or other consideration that BioLine or an Affiliate of BioLine actually 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 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 that Sublicensing 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 or payment to one or more third parties to obtain a Third Party License from such third party(ies) in order to practice the Licensed Technology. For the avoidance of doubt, Sublicensing Receipts shall not include any amounts received as Grants, in connection with Government Programs, or otherwise as research grants from national or international not-for-profit funding bodies, or in connection with an M&A Transaction.
“Sublicensee” shall mean a person or entity granted a Sublicense in accordance with Section 2.2, including any sublicensees of other Sublicensees.
“Third Party License” shall mean a license from an unaffiliated third party 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.
4
“Trial” shall mean a clinical trial or trials performed by BioLine or a third party engaged by BioLine either in countries of the European Union or in the USA, as part of Phase I and Phase II clinical trials, pursuant to which treatment based on the Licensed Technology is administered to not less than sixty (60) subjects. It is agreed that following the receipt of the Trial's Final Clinical Study Report from the Clinical Research Organization (CRO), it shall have the right to treat more subjects in Israel.
2.2.2. Sublicense Agreements. Sublicenses shall only be granted pursuant to written agreements. BioLine shall provide Licensor with a copy of each sublicense agreement within (30) days of receipt of an executed draft thereof from the Sublicensee. Each such sublicense agreement shall contain, inter alia, provisions to the following effect:
2.2.2.1. All provisions necessary to ensure BioLine’s ability to perform its obligations under this Agreement, including reporting and audit requirements;
2.2.2.2. In the event of termination of the license set forth in Section 2.1 above (in whole or in part – e.g. termination in a particular country), any existing agreements that contain a Sublicense of, or other grant of right with respect to, Licensed Technology 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, Licensor shall be obligated, at the request of such Sublicensee, 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; and
5
2.2.3. 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 execution of a written agreement consistent with the terms of this Section, and shall be made for consideration and in arm’s length transactions.
2.3. Contractors and Affiliates. BioLine shall have the right to utilize third party contractors in connection with BioLine’s activities in exploiting the license granted hereunder. Provided that such contractors perform activities on BioLine’s behalf, and BioLine maintains control of and remains solely responsible for such activities, the provisions of Section 2.2 shall not apply with respect to such contractors. Sublicenses to Affiliates of BioLine shall not be considered Sublicenses under this Agreement.
Subject to the license granted to BioLine pursuant to the terms of this Agreement, all rights, title and interest in and to the Licensed Technology are and shall be owned solely and exclusively by Licensor. Licensor shall not accept any funding from any third party for research relating or connected to the Licensed Technology without the prior written consent of BioLine.
4.2. [***]
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
6
4.4. 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.
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
7
6.1.1. [***] shall be paid to Licensor within ten (10) days following the execution of this Agreement.
6.1.2. [***]
6.1.2.1. [***]
6.1.2.2. [***]
6.1.3. [***]
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
8
6.1.4. The License Fee shall be non-refundable.
(a) the number of units of Licensed Products sold by BioLine and its Affiliates in each country for the applicable Calendar Quarter;
(b) the gross amount billed for the Licensed Product sold by BioLine and its Affiliates in each country during the applicable Calendar Quarter;
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
9
(c) a calculation of Net Sales for the applicable Calendar Quarter in each country, including a listing of applicable deductions;
(d) the total amount payable to Licensor in U.S. dollars on Net Sales for the applicable Calendar Quarter, together with the exchange rates used for conversion on the date that the sale was recognized in accordance with IFRS (IAS 21); and
(e) a calculation of any Sublicense Receipts for the applicable Calendar Quarter.
The report shall state if no amounts are due to Licensor for any Calendar Quarter.
10
11
12
13
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
14
10.1.1. Licensor hereby represents and warrants that (i) it has sole and exclusive ownership of the patents and/or patent applications listed in Exhibit A attached hereto; (ii) it has not granted any rights in or to Licensed Technology that are inconsistent with the rights granted to BioLine under this Agreement; (iii) it has the right to grant the license granted under this Agreement free and clear of any third party rights or claims; (iv) it will not transfer, assign, grant rights to, sell, lease or otherwise dispose of or encumber the Licensed Technology other than as may be expressly permitted herein; and (v) there are no legal claims, demands, threats or proceeding of any sort by any third party against the Licensor contesting the ownership or validity of the Licensed Patents, or claiming that the practice of the Licensed Patents in the manner contemplated by this Agreement would infringe the rights of such third party.
10.1.2. BioLine hereby represents and warrants that it (i) is a drug development company, (ii) has received and carefully reviewed, to its satisfaction, all the information it considers necessary or appropriate for deciding whether to enter into this Agreement, and (iii) has reached the decision to fulfill its obligations hereunder as a result of careful consideration. Without derogating from the aforementioned, BioLine further represents that it has had an opportunity to ask questions of and receive answers from Licensor regarding the intellectual property and the inventions of Licensor and has performed its independent due diligence with respect thereto after having received from Licensor the due diligence materials it requested.
15
11.
|
16
12.3.1. Termination Without Cause and for Scientific, Regulatory or Medical Reasons.
12.3.1.1. BioLine may terminate this Agreement without cause upon thirty (30) days prior written notice to Licensor; provided, however, that in the event that BioLine exercises such right prior to the completion of the Trial, BioLine shall pay for the completion of the Trial; and provided further that the total amount that BioLine shall be obligated to pay in respect of the Trial (including amounts spent by BioLine prior to the exercise of the termination right hereunder, but excluding the Licensee Fee mentioned in Section 6.1) shall in no event exceed the sum of six hundred thousand United States Dollars (US $600,000). For the avoidance of doubt, BioLine shall not be obligated to pay any amounts hereunder in the event that BioLine terminates the Agreement pursuant to this subsection 12.3.1.1 after the completion of the Trial.
12.3.1.2. BioLine may terminate this Agreement at any time upon sixty (60) days’ prior written notice to Licensor for scientific, regulatory or medical reasons which would prevent BioLine from continuing the development of the Licensed Technology pursuant to the Development Plan as may be determined by BioLine’s Scientific Advisory Board (“SAB”). Prior to the exercise of such right, Licensor shall have the right to present orally and/or in writing its opinion regarding the proposed termination to the SAB and offer its solutions for the obstacles and/or problems raised by the SAB. For the purpose of preparing for its presentation to the SAB, Licensor may contract with an independent expert to assist with such preparation and such expert shall have the right to present before the SAB. BioLine agrees to contribute up to [***] to offset any documented costs directly incurred by Licensor in retaining such expert against presentation of appropriate invoices. It is specifically agreed between the parties that in the event that BioLine terminates the Agreement pursuant to this subsection 12.3.1.2, regardless of whether such termination occurs prior to the completion of the Trial, BioLine shall not be obligated to pay any amounts in respect of the completion of the Trial.
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 thirty (30) 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 uses diligent good faith efforts to cure such breach, the stated period will be extended by an additional thirty (30) days. In the event of an uncured material breach by BioLine, Licensor may elect not to terminate this Agreement but, instead, to xxx BioLine for damages arising from such breach.
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
17
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 or default within thirty (30) 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 or default is not susceptible of cure within the stated period and Licensor uses diligent good faith efforts to cure such breach or default during the initial thirty (30) day cure period, the stated period will be extended by an additional thirty (30) days. In the event of an uncured material breach by Licensor, BioLine may elect not to terminate this Agreement but, instead, to xxx Licensor for damages arising from such breach.
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 BioLine has entered into a settlement with its creditors and BioLine is otherwise meeting its obligations pursuant to this Agreement, Licensor shall not be entitled to terminate this Agreement as contemplated under Section 12.3.3.1 during such period.
18
13.
|
If to BioLine:
|
BioLine Innovations Jerusalem, LP
00 Xxxxxx Xxxxxx
X.X. Xxx 00000
Xxxxxxxxx 00000
Xxxxxx
Attention: VP Finance, BioLineRx, Ltd.
Fax: 000-0-000-0000
|
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
19
With a copy (which shall not constitute notice) to:
|
Xxxxx Xxxxx & Co., Law Offices
00 Xxxxxx Xxxxxx
Xxxxxxxxx, 00000
Israel
Attention: Xxxxx Xxxxxxxxx, Adv.
Fax: 000-0-000-0000
|
|
If to the Licensor:
|
Innovative Pharmaceutical Concepts (IPC) Inc.
Xxxxxx Xxxxx, 0xx Xxxxx, 000 Xxxxxxxxxx Xxxxx
P.O. Box 3339, Road Town, Tortola
British Virgin Islands
Attention: Xx. X. Xxxxxxxx
Fax: 000-0-000-0000
|
|
With a copy (which shall not constitute notice) to:
|
Xxxxx X. Xxxxx, Ashlagi, Fisher, Eshel – Law Offices
0 Xxxxxxx Xxxxxx
Xxx-Xxxx, 00000
Xxxxxx
Attention: Xxx Xxxxxx, Adv.
Fax: 000-0-000-0000
Email: xxx@xxxxxx.xx.xx
|
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 business day after transmission or dispatch; (iii) by airmail, three (3) business days after delivery to the postal authorities by the party serving notice.
20
[Remainder of page intentionally left blank]
21
[Signature page to License Agreement]
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Innovative Pharmaceutical Concepts
|
BioLine Innovations Jerusalem L.P.
|
(IPC) Inc.
|
By its General Partner:
|
BioLine Innovations Jerusalem Ltd.
|
|
By: /s/ X. Xxxxxxxx
|
By: /s/ Xxxxxx Xxxxxx /s/ Xxxxx Xxxxxx
|
Name: Xx. Xxxxxxx Xxxxxxxx
|
Name: ________________________
|
Title: Director
|
Title: _________________________
|
22
Exhibit A
Patents and/or Patent Applications
[***]
23
Exhibit B
Development Plan
ID
|
Task
Name
|
Start
|
Finish
|
Cost
|
2005
|
2006
|
2007
|
2008
|
2009
|
2010
|
||||||||||
|
|
|
|
|
|
|
|
|
|
[***]
24
Non-surgical removal of benign tumors and lesions of the skin
Development Plan
[***]
[***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the SEC.
25