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BioLineRx Ltd.
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By:
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/s/ Philip Serlin
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Philip Serlin
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Chief Executive Officer
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Tel. 972-3-69441111
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Fax. 972-3-6091116
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fbc@fbclawyers.com
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Very truly yours,
/s/ FISCHER (FBC & Co.)
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Greenberg Traurig, P.A. | Attorneys at Law
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Azrieli Center, Round Tower | 132 Menachem Begin Road, 30th Floor | Tel Aviv, Israel 6701101 | T +1 +972 (0) 3 636 6000 | F +1 +972 (0) 3 636 6010
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www.gtlaw.com
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Very truly yours,
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/s/ Greenberg Traurig P.A.
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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.
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2. |
License Grant.
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2.1. |
Product License Grant. Subject to terms and conditions hereof, BioLine hereby grants to Ayrmid an exclusive, transferable (on the terms and conditions herein), royalty-bearing, sublicensable, license
under BioLine’s rights in the Licensed Product and the Licensed Technology to Commercialize the Licensed Product and any New Development Products, solely within the Field in the Territory. For purposes of this Section 2.1, the term
“exclusive” means that BioLine shall not have any right to grant such licenses or rights, whether to a third party or an Affiliate, in the Territory in the Field with respect to the foregoing or engage in any of the foregoing in the Territory
in the Field (whether directly or indirectly) except with the written permission of Ayrmid. Notwithstanding the foregoing, and for the avoidance of doubt, BioLine reserves all rights to (i) engage in any and all of the foregoing outside the
Territory directly and/or via third parties; (ii) directly and/or via third parties, make, manufacture and have made or manufactured the Licensed Product within the Territory for the purposes of (x)
Commercializing the Licensed Product outside of the Territory or (y) supplying the Licensed Product to Ayrmid; and (iii) grant rights to third parties comparable to the rights granted herein to Ayrmid
outside the Field in the Territory. Notwithstanding anything to the contrary herein, BioLine shall not have the right to enter into agreements with distributors of the Licensed Product (or any similar
distribution arrangements) with respect to the Field in the Territory.
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2.2. |
Trademarks License. Subject to the terms hereof, BioLine hereby grants to Ayrmid a limited, exclusive, transferable (on the terms and conditions herein) and royalty-free license to the Licensed
Trademarks and associated goodwill during, subject to the terms of Section 13.3.1.2 below, the term of this Agreement and solely for the Commercialization of the Licensed Product and any New Development Products in accordance with this
Agreement in the Field and within the Territory and on the condition that Ayrmid shall not at any time do or permit any act to be done which may in any way impair the rights of BioLine in the Licensed Trademarks and shall not use the Licensed
Trademarks in a manner which dilutes, detracts from or damages the goodwill appurtenant thereto. Ayrmid shall not register any Licensed Trademarks or derivative thereof unless expressly advised to do so by BioLine, and Ayrmid shall follow all
reasonable written instructions from BioLine with respect to use of the Licensed Trademarks. BioLine reserves the right to add to, change, or discontinue the use of the Licensed Trademarks, on a selective or general basis, at any time, by
providing written notice to Ayrmid; provided that any such addition, change or discontinuance which would have an adverse effect on Ayrmid’s (or its Affiliates’ or Sublicensees’) Commercialization of
the Licensed Product shall require the prior written consent of Ayrmid. Ayrmid agrees that BioLine may register Ayrmid as an authorized user of the Licensed Trademarks and shall cooperate with BioLine in such respect upon reasonable request.
All goodwill arising from Ayrmid’s use of Licensed Trademarks will inure solely to the benefit of BioLine. Subject to the licenses (and, as applicable, sublicenses) contemplated by this Section 2.2 and Section 13.3.1.2, title to and ownership
of all proprietary rights in or related to the Licensed Trademarks remains at all times with BioLine. Ayrmid further irrevocably assigns and will assign to BioLine in perpetuity all worldwide right, title and interest, if any, that are owned
or obtained by Ayrmid in any of the Licensed Trademarks. Ayrmid shall have the right to sublicense its rights under this Section 2.2; provided that (i) in the case of a sublicense to an Affiliate of
Ayrmid, such Affiliate shall be bound by all of Ayrmid’s obligations hereunder and Ayrmid shall promptly notify BioLine of such sublicense, and (ii) in the case of a sublicense to a third party, such sublicense shall be made only in
connection with a Sublicense of Licensed Technology being made in accordance with the applicable terms of this Agreement (including, for the avoidance of doubt, Sections 2.3 and 2.4) and the applicable Sublicense agreement shall contain terms
and conditions in respect of the Licensed Trademarks that are consistent with this Section 2.2. For purposes of this Section 2.2, the term “exclusive” means that BioLine shall not have any right to grant such licenses or rights, whether to
an Affiliate or to any third party, in the Field in the Territory with respect to the foregoing or engage in use of the Licensed Trademarks in the Field in the Territory (whether directly or indirectly) except with the written permission of
Ayrmid. For the avoidance of doubt, BioLine reserves all rights to (i) engage in any and all of the foregoing outside the Territory directly and/or via third parties; (ii) directly and/or via third
parties, engage in the use of the Licensed Trademarks within the Territory for the purposes of (x) Commercializing the Licensed Product outside of the
Territory or (y) supplying the Licensed Product to Ayrmid; and (iii) grant rights to third parties comparable to the rights granted herein to Ayrmid outside the Field in the Territory.
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2.3. |
Sublicenses. Ayrmid shall be entitled to grant Sublicenses under the License to third parties, it being clarified that Sublicenses shall be granted for consideration and in arm’s length transactions.
Any such grant of a Sublicense shall not require the prior written consent of BioLine, but shall be subject to the following:
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2.3.1. |
Alternative Prospective Sublicensee. Prior to granting any Sublicense to a third party (the “Prospective Sublicensee”):
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2.3.1.1. |
Ayrmid will provide BioLine with a written notice (the “Sublicense Notice”) that will include: (a) Ayrmid’s desire to grant a Sublicense to the Prospective Sublicensee; and (b) the principal
commercial terms of the proposed Sublicense. Within [***] days of receipt of the Sublicence Notice, BioLine may provide a written notice (the “Response”) to Ayrmid indicating that BioLine has identified
an alternative third party (the “Alternative Prospective Sublicensee”) who has provided BioLine with a term sheet containing financial terms objectively more favorable than those set out in the
Sublicense Notice (such terms to be included in the Response), in which case Ayrmid will commence negotiations with the Alternative Prospective Sublicensee for the grant of the Sublicense, provided that should such negotiations fail to
generate a binding, written and definitive sublicense agreement within [***] days, Ayrmid shall be free to proceed to grant a Sublicense to the Prospective Sublicensee.
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2.3.1.2. |
In the event that BioLine notifies Ayrmid in writing that it does not wish to propose an Alternative Prospective Sublicensee or does not provide Ayrmid with a Response within the aforementioned [***] day period, Ayrmid shall be entitled to
grant the aforementioned Sublicense to the Prospective Sublicensee with no further obligations in respect thereof to BioLine (save and except for the remaining provisions of this section).
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2.3.2. |
Sublicense Agreements. Sublicenses shall only be granted pursuant to written agreements. Ayrmid shall provide BioLine with a copy of (i) the proposed final draft of each Sublicense agreement into
which it intends to enter for BioLine’s review [***] 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 Ayrmid may not be able to provide BioLine with an absolute final draft prior to execution, and (ii) the final executed version of each Sublicense agreement into which it enters within [***] days after receipt of an
executed draft thereof from the Sublicensee. For the avoidance of doubt, it is hereby clarified that should the proposed final execution version of the Sublicense agreement include material changes from the proposed final draft provided to
BioLine for review pursuant to (i) above, Ayrmid shall specifically notify BioLine of such material changes within reasonable time prior to execution. BioLine shall have a right to comment on, and to object to, in each case, (x) within the
[***] day period set forth in (i) above or (y), in the case of material changes contemplated by the foregoing sentence, promptly upon receipt of notice from Ayrmid in connection therewith, the Sublicense agreement only to the extent that it
provides rights to the Sublicensee that are inconsistent with, or deviate from, the terms of this Agreement, in which case such Sublicense agreement shall not come into effect.
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2.3.3. |
Each Sublicense agreement shall be consistent with the terms of the Agreement and shall contain, inter alia, provisions to the following effect:
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2.3.3.1. |
All provisions necessary to ensure Ayrmid’s ability to perform its obligations under this Agreement, including reporting and audit requirements; and
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2.3.3.2. |
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 Ayrmid such that Ayrmid would have the right to terminate such Sublicense, BioLine 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; 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 BioLine which are not included in this Agreement.
BioLine’s consent to such Sublicensee request shall not be unreasonably withheld.
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2.3.4. |
Ayrmid undertakes to take all actions reasonably necessary to enforce its rights under its agreements with its Sublicensees. Any act or omission by a Sublicensee which would have constituted a Material Breach of this Agreement had it been
an act or omission by Ayrmid, shall constitute a Material Breach of this Agreement; provided, however, that (i) any such breach shall be subject to a cure period consistent with the terms of this
Agreement and (ii) such breach shall not constitute a Material Breach of this Agreement in the event Ayrmid terminates the applicable Sublicense agreement with such Sublicensee (whether or not prior to or promptly after the expiration of the
cure period applicable to the breach). For clarity, a termination by Ayrmid of the applicable Sublicense agreement pursuant to (ii) of the foregoing sentence shall not, in and of itself, absolve Arymid of liability towards BioLine arising
from such breach by such Sublicensee.
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2.3.5. |
A Sublicensee shall be entitled to Sublicense its rights under a Sublicense agreement without BioLine’s prior written consent, provided that each Sublicense agreement shall provide that the grant of such Sublicense shall comply with the
applicable terms and conditions of this Agreement (including, for the avoidance of doubt, this Section 2.3) as if such Sublicense were being made by Ayrmid hereunder.
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2.3.6. |
Other than as specifically set forth in this Agreement, Ayrmid and its Sublicensees shall not be entitled to grant, directly or indirectly, to any person or entity any right of whatever nature (i) under, or with respect to, or permitting
any use or exploitation of, any of the Licensed Technology or (ii) to Commercialize the Licensed Product.
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2.4. |
Contractors and Affiliates. Notwithstanding anything to the contrary herein, Ayrmid and its Affiliates and Sublicensees shall have the right to utilize third party contractors (including, for the
avoidance of doubt, distributors and manufacturers) in connection with their respective activities in exploiting the Licenses, provided that such third party contractors do not compensate Ayrmid in any manner in the context of such
engagements (except for compensation by distributors for the purchase of products). The provisions of 2.3, as well as the applicable provisions of Section 2.2 relating to sublicenses of the Licensed Trademarks, shall not apply with respect to
such contractors. For the avoidance of doubt, Sublicenses to Affiliates of Ayrmid shall not be considered Sublicenses under this Agreement, provided that upon such transaction such Affiliate shall be bound by all of Ayrmid’s obligations
hereunder and Ayrmid promptly notifies BioLine of such transaction. Ayrmid undertakes to take all actions reasonably necessary to enforce its rights under its agreements with its third party contractors. Any act or omission by a third party
contractor which would have constituted a Material Breach of this Agreement had it been an act or omission by Ayrmid, shall constitute a Material Breach of this Agreement; provided, however, that (i)
any such breach shall be subject to a cure period consistent with the terms of this Agreement and (ii) such breach shall not constitute a Material Breach of this Agreement in the event the applicable contractor or similar agreement with such
third party contractor is terminated (whether or not prior to or promptly after the expiration of the cure period applicable to the breach). For clarity, a termination by Ayrmid of the applicable contractor or similar agreement pursuant to
(ii) of the foregoing sentence shall not, in and of itself, absolve Arymid of liability towards BioLine arising from such breach by third party contractor.
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2.5. |
Gloria Agreement. BioLine hereby covenants and agrees that, with respect to that certain License Agreement, dated as of August 27, 2023, by and among BioLine, Guangzhou Gloria Biosciences Co., Ltd.
and Hong Seng Technology Limited (collectively, “Gloria”) (as amended, modified or supplemented from time to time, the “Gloria Agreement”), BioLine (i) shall
enforce the terms and conditions of the Gloria Agreement to ensure that there is no adverse effect on the exclusivity of the Licenses granted to Ayrmid hereunder and Ayrmid’s rights in respect of the Commercialization of the Licensed Product
in the Field and the Territory, (ii) shall not amend, waive, supplement or otherwise modify the Gloria Agreement in a manner that would have an adverse effect on the exclusivity of the Licenses granted to Ayrmid hereunder and Ayrmid’s rights
in respect of the Commercialization of the Licensed Product in the Field and the Territory, and (iii), to the extent not covered by the foregoing, shall not consent to or otherwise approve or authorize the Commercialization or other use by
Gloria of any of the Licensed Product, Licensed Technology, Licensed Trademarks, Licensee Independent Developments (as defined in the Gloria Agreement) or Jointly Owned Licensee Developments (as defined in the Gloria Agreement) in the
Territory; provided that nothing in (iii) above shall be read or interpreted so as to require BioLine to, or otherwise impose upon BioLine an obligation to, breach any of the terms of the Gloria
Agreement. In addition to the foregoing, the Parties agree and acknowledge that the obligations of BioLine under this Section 2.5 shall apply to any similarly situated sublicensee or other person or entity (including, without limitation,
Affiliates of BioLine) on a mutatis mutandis basis.
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2.6. |
Supply Exception. Except as may be provided otherwise in the Supply Agreement (including, for the avoidance of doubt, pursuant to the exercise of the Step-in Rights (as defined in the Supply
Agreement) contemplated thereby), the supply of Licensed Products for the Territory by Ayrmid shall only be performed through BioLine in accordance with the Supply Agreement.
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3. |
Title.
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3.1. |
Title. Subject to the Licenses granted to Ayrmid pursuant to the terms of this Agreement (and any and all Sublicenses granted by Ayrmid in accordance with the terms and conditions herein), all
rights, title, and interest in and to the Licensed Technology shall be owned solely and exclusively by BioLine and its licensors.
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3.2. |
New Developments. As between the Parties, any inventions Developed, made, conceived or created by Ayrmid, its Affiliates and/or Sublicensees that relate to the Licenses (including but not limited to
any improvement of the performance or efficacy of the Licensed Product, a reduction of any side effects, drug interactions or other adverse effects of the Licensed Product, new indications, drug administration methods, an increase in the
efficiency or productivity of the manufacturing and production process for the Licensed Product) and all intellectual property rights therein (all of the foregoing, “New Developments”) shall be the sole
property of Ayrmid.
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4. |
Patent Management.
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4.1. |
Prosecution and Maintenance. The Parties shall consult each other regarding the preparation, filing and prosecution of all patent applications, and the maintenance of all patents included within the
Licensed Patents in the Territory, including, without limitation, the content, timing and jurisdiction of the filing of such patent applications and their prosecution, and other details, to enable the Parties to ensure a consistent overall
global strategy pertaining to the prosecution and maintenance of the Licensed Patents. Ayrmid, following such consultation with BioLine, shall file, prosecute, and maintain any Licensed Use Patents in the Field and in the countries of the
Territory and shall be considered as the Controlling Party in that respect. BioLine, following such consultation with Ayrmid, shall file, prosecute, and maintain any Licensed Composition Patents and shall be considered as the Controlling
Party in that respect. The filing, prosecuting and maintenance of Licensed Patents as aforesaid shall be in accordance with the following conditions:
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4.1.1. |
Each application and every patent registration as aforesaid shall be registered in the name of BioLine and/or BioLine and the Upstream Licensor, and automatically added to the Licenses granted pursuant to this Agreement.
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4.1.2. |
With respect to the Licensed Patents under its control as aforesaid, the Controlling Party shall make patent prosecution decisions (such as the filing of continuation and decisional applications, abandoning an application, changing claims
in the course of prosecution or contentious proceedings, electing inventions, and presenting arguments in the course of prosecution of contentious proceedings) and file patent applications only after review and comment by the Non-Controlling
Party of such decisions and the text of such applications, and only after such Controlling Party considers, in good faith, such input from the Non-Controlling Party.
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4.1.3. |
The Non-Controlling Party shall provide its comments on patent prosecution decisions or patent applications as aforesaid within [***] days of receipt of the proposed text of such prosecution decision or patent application. In the event
that the Non-Controlling Party fails to provide its comments within such time period, the Controlling Party may proceed to make and file such decisions and filings.
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4.1.4. |
The Controlling Party shall provide the Non-Controlling Party with a copy of all material documents generated or received by the Controlling Party and/or its attorneys in connection with the prosecution and maintenance of the Licensed
Patents under its control, including briefs, office actions, examinations, and correspondence. In order to avoid delays in the provision of such documents, the Controlling Party (i) shall instruct its patent counsel to provide simultaneous
copies of all correspondence to both Parties, and (ii) shall provide the Non-Controlling Party with a copy of any such document it receives that has not also been sent to the Non-Controlling Party within [***] ([***]) days of its receipt.
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4.1.5. |
Except for a termination event under Section 13.2.3 that implicates the rights of Ayrmid under the Biokine Letter Agreement or a termination event arising from a CRE Jurisdiction Breach, in any event of termination of the License with
respect to a Licensed Use Patent, the control of the patent file with respect to such Licensed Use Patent (and in case of termination of such License in its entirety, the control of all Licensed Use Patent files) shall revert to BioLine. In
such a case, Ayrmid shall take all necessary steps to (i) notify the relevant patent offices that BioLine has assumed the sole right to prosecute and maintain the Licensed Use Patents; and (ii) instruct its patent attorney or attorneys to
transfer the patent file and the right to act on behalf of BioLine with respect to such Licensed Use Patents to BioLine itself, or to another attorney or patent attorney which BioLine shall identify.
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4.2. |
Reimbursement. Ayrmid shall be responsible for (i) bearing all patent-related expenses with respect to the Licensed Use Patents in the Territory, and (ii) reimbursing BioLine for one-half of all
documented on-going expenses with respect to the Licensed Composition Patents in the Territory, in the case of each of (i) and (ii), (x) to the extent arising from and after the License Effective Date and (y) provided there are no other
licensees to the Licensed Composition Patents in the Territory. If there are other licensees to the Licensed Composition Patents in the Territory (i.e., outside the Field), then the documented on-going expenses in respect of the Licensed
Composition Patents will be shared equally among the licensees and BioLine, so that Ayrmid’s reimbursement obligations under (ii) above shall be reduced on a pro-rated basis (for instance, in case of an additional licensee, Ayrmid shall
reimburse BioLine for [***] of the expenses; in case of [***] additional licensees, Ayrmid shall reimburse BioLine for [***]of the expenses, and so on). BioLine shall promptly inform Ayrmid upon the grant of any rights to the Licensed
Composition Patents to another licensee and will provide Ayrmid with all reasonable information to support the equitable division of the patent related cost and expenses as per the foregoing.
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4.3. |
Abandonment. If Ayrmid decides that it does not wish to pay for the preparation, filing, prosecution, protection or maintenance of any patents or patent applications that are included within the
Licensed Use Patents or the Licensed Composition Patents (“Abandoned Patent Rights”), Ayrmid shall provide BioLine with notice of such election within [***] days of Ayrmid’s decision to abandon the
patent (and in the case of an existing patent or patent application, at least [***] days prior to the expiration thereof). Ayrmid shall then be released from any obligation to bear any costs or expenses in respect of such Abandoned Patent
Rights. At the written request of BioLine provided to Ayrmid within [***] days of the receipt of the foregoing election, Ayrmid shall cooperate with BioLine, and take actions necessary to transfer responsibility for such payments for Licensed
Use Patents to BioLine. In such event, any license granted by BioLine to Ayrmid hereunder with respect to such Abandoned Patent Rights will terminate, and Ayrmid will have no rights whatsoever to exploit such Abandoned Patent Rights. BioLine
shall then be free (but not obligated), without further notice or obligation to Ayrmid, to continue the preparation, filing, protection, prosecution, and maintenance of any Abandoned Patent Rights and/or grant rights in and to such Abandoned
Patent Rights, and related Licensed Know-How, to third parties in the Territory.
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4.4. |
No Warranty. Nothing contained herein shall be deemed to be a warranty by either of the Parties that it 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.
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5. |
Diligence and Supply Arrangement; Steering Committee.
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5.1. |
Diligence Obligations.
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5.1.1. |
Ayrmid shall use Commercially Reasonable Efforts (which obligation may be satisfied through its Affiliates and/or Sublicensees) to Commercialize the Licensed Products within the [***], [***], [***], [***], [***]and [***] (each, a “CRE Jurisdiction”). Without derogating from the foregoing, the following in Section 5 shall also apply:
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5.1.2. |
BioLine shall conduct and complete, at its own cost and expense, any and all outstanding or ongoing clinical development activities that are required to obtain and/or maintain, or that constitute a condition to the obtainment and/or
maintenance of, as applicable, Regulatory Approval for the Licensed Product in the United States, including, for the avoidance of doubt, that certain clinical trial “BL-8040sCM.301”.
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5.1.3. |
Ayrmid shall use Commercially Reasonable Efforts to accomplish or otherwise satisfy the following: (i) obtaining and maintaining Regulatory Approvals (where Regulatory Approval is required to give effect to the Commercialization strategies
of Ayrmid in a certain country within the Territory) in accordance with local regulations and applicable laws and for all communications with Regulatory Agencies, in each case, with respect to the Licensed Product in the CRE Jurisdictions and
such other countries within the Territory that Ayrmid identifies as being material to the Commercialization strategies of Ayrmid in respect of the Licensed Product in its sole discretion (such countries, together with all CRE Jurisdiction
countries, collectively, the “Relevant Countries”); (ii) Commercializing the Licensed Product in the Relevant Countries, including but not limited to market development, liaising with patient advocacy
groups, key opinion leader (KOL) development, market access strategy, market research, and pricing research activities for the Licensed Product; (iii) conducting and completing any further development activities and regulatory activities for
additional indications within the Field that Ayrmid identifies in its sole discretion as being material to the Commercialization strategies of Ayrmid with respect to the Licensed Product in the Relevant Countries; (iv) conducting
post-approval clinical studies that Ayrmid identifies in its sole discretion as being material to the Commercialization strategies of Ayrmid with respect to the Licensed Product in the Relevant Countries; and (v) obtaining and maintaining
pricing approvals and reimbursement health insurance coverage in the Relevant Countries.
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5.2. |
Information Sharing.
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5.2.1. |
BioLine Data. Upon Ayrmid’s reasonable request and subject to pre-existing confidentiality obligations, BioLine will make the following information and material reasonably available to Ayrmid: (i)
relevant data, information, and documents (including clinical and non-clinical/CMC data) regarding the Licensed Product, the Licensed Technology and the Licensed Trademarks, including, without limitation, periodic reviews, reports and updates
conducted in respect of the Licensed Product by manufacturers thereof (including, for the avoidance of doubt, any such reviews and reports describing any major and/or critical deviations from the ordinary course manufacture of the Licensed
Product) and such other data, information and documents relating to the manufacture of the Licensed Product as are reasonably necessary for Ayrmid’s continued Commercialization of the Licensed Product and which is in BioLine’s possession and
Control; and (ii) periodic updates concerning the progress of clinical trials involving the Licensed Product being conducted outside the Territory. With respect to clinical and non-clinical/CMC data, in addition to providing such data
to Ayrmid, BioLine shall also grant to Ayrmid appropriate rights to reference such data. The foregoing will be made available by uploading it to Ayrmid’s data management system. Ayrmid will cooperate technically to enable such upload to
occur.
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5.2.2. |
Material Updates. Each Party will promptly notify the other Party upon such Party becoming aware of any serious adverse event (including with respect to any Regulatory Approvals) related to the
exercise of the Licenses.
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5.2.3. |
Ayrmid Information Reports.
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5.2.3.1. |
At the end of each Calendar Quarter, Ayrmid shall furnish BioLine with a written report on the progress of its, its Affiliates’ and Sublicensees’ efforts during such preceding Calendar Quarter to develop and Commercialize the Licensed
Product and New Developments in the Field and the Territory consistent, in each case, with the illustrative report attached hereto as Exhibit D.
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5.2.3.2. |
Concurrent with Ayrmid’s furnishing of the written report to BioLine pursuant to Section 5.2.3.1 above, to the extent (x) in Ayrmid’s possession and Control and (y) not already covered by the information set forth in such written report,
Ayrmid shall additionally provide to BioLine (i) relevant data, information and documents (including clinical and non-clinical / CMC data and regulatory data) with respect to the Licensed Product and Licensed Technology (“Reporting Data”) and (ii) updates concerning the progress of clinical trials involving the Licensed Product being conducted in the Territory and relating to the Reporting Data.
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5.2.3.3. |
In addition to the foregoing, within any Calendar Quarter, BioLine shall have the right to request, with written notice to Ayrmid, that Ayrmid promptly provide any Reporting Data that is reasonably necessary for BioLine’s compliance with
or satisfaction of (as applicable) any matters that, absent such compliance or satisfaction, would result in a BioLine MAE and, in such event, Arymid shall provide such data.
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5.2.3.4. |
With respect to the Reporting Data, (i) in the event the transmission of the Reporting Data is achievable solely by means of electronic or digital transmission, (x) Ayrmid shall make the Reporting Data available to BioLine by uploading it
to BioLine’s data management system and (y) BioLine shall cooperate with Ayrmid in enabling such upload to occur, and (ii) Ayrmid shall concurrent with transmission thereof grant to BioLine appropriate rights to reference the Reporting Data.
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5.2.3.5. |
Ayrmid will make its representatives on the Steering Committee (as defined below) available to address any questions and issues raised by BioLine in respect of the reports and Reporting Data provided to BioLine pursuant to this Section
5.2.3.
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5.3. |
Steering Committee. The Parties agree to establish a steering committee (the “Steering Committee”) to review and discuss (i) the progress being made by Ayrmid
in respect of the Commercialization of the Licensed Product and any other research and development activities conducted by Ayrmid, its Affiliates and Sublicensees relating to the Licensed Product; (ii) any information and material made
available by either Party pursuant to this Agreement; and (iii) and other material developments that may arise during the term of this Agreement. Each of BioLine and Ayrmid will be entitled to designate up to two (2) representatives to the
Steering Committee. The Steering Committee will meet no more than twice per Calendar Year, unless in connection with a serious adverse event, during the term of this Agreement commencing from the License Effective Date, at locations and times
to be mutually agreed upon by the members of the Steering Committee (it being agreed that meetings may be virtual). For the avoidance of doubt, the Steering Committee shall be a forum for the exchange of information between the Parties with
respect to the foregoing and shall not have decision-making powers.
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5.4. |
Safety Committee. The Parties agree to establish a safety committee (the “Safety Committee”) to review and discuss (i) reportable safety information (adverse
events, product quality complaints, and special situations) from clinical and commercial sources; (ii) signal management review; (iii) review of relevant literature; (iv) the process for PADER submission, including preparation, exchange of
information between Ayrmid and BioLine, and related review processes; and (v) other safety related matters that may arise during the term of this Agreement. Each of BioLine and Ayrmid will be entitled to designate up to two (2)
representatives to the Safety Committee. The Safety Committee will meet bi-weekly during an initial period of six (6) months from the License Effective Date, and then thereafter once per Calendar Quarter, unless in connection with a serious
adverse event, during the term of this Agreement commencing from the License Effective Date, at locations and times to be mutually agreed upon by the members of the Safety Committee (it being agreed that meetings may be virtual). For the
avoidance of doubt, the Safety Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing and shall not have decision-making powers.
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6. |
Fees and Consideration.
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6.1. |
Upfront Payment. Ayrmid shall pay to BioLine a non-refundable, up front license fee in the amount of US $10,000,000 within 10 days after the License
Effective Date (the “Upfront Payment”).
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6.2. |
Sales Milestones. Ayrmid shall make the following milestone payments outlined below (each, a “Sales Milestone Payment) to BioLine upon the occurrence of the
milestone events corresponding thereto (each, a “Sales Milestone Event”) as follows: (i) if such Sales Milestone Payment is subject to reaching a minimum Net Sales within a Calendar Year, then payment
will be due within [***] days after the end of such Calendar Year; and (ii) for any other Sales Milestone Payment, within [***] days after the occurrence of the Sales Milestone Event. Each such Sales Milestone Payment shall be payable one
time only. For clarity, if more than one of the Sales Milestone Events are met for the first time in the same Calendar Year, Ayrmid shall pay all Sales Milestone Payments corresponding to such achieved Sales Milestone Events to BioLine for
that Calendar Year. Sales Milestone Payments are non-refundable and non-creditable. The Parties agree and acknowledge that, as used in the following #1-10, the term “Net Sales” shall exclude any and all Reduced-Royalty Net Sales (as defined
below).
|
Milestone Event
|
Payment
|
1. Upon reaching $[***] in Net Sales
in any Calendar Year
|
$2,000,000
|
2. Upon reaching $[***] in Net Sales
in any Calendar Year
|
$4,000,000
|
3. Upon reaching
$[***] in Net Sales in any Calendar Year
|
$7,500,000
|
4. Upon reaching
$[***] in Net Sales in any Calendar Year
|
$12,000,000
|
5. Upon reaching
$[***] in Net Sales in any Calendar Year
|
$15,000,000
|
6. Upon reaching
$[***] in Net Sales in any Calendar Year
|
$25,000,000
|
7. Upon reaching
$[***] in cumulative Net Sales for the treatment of Sickle Cell Disease
|
$2,500,000
|
8. Upon reaching
$[***] in Net Sales for the treatment of Sickle Cell Disease in any Calendar Year
|
$5,000,000
|
9. Upon reaching
$[***] in Net Sales for the treatment of Sickle Cell Disease in any Calendar Year
|
$7,500,000
|
10. Upon First
Commercial Sale in Europe post Regulatory Approval
|
$1,500,000
|
11. Upon
reaching $[***] in Net Sales in Europe in any Calendar Year
|
$5,000,000
|
6.3. |
Royalty Payments. Ayrmid shall pay BioLine a running royalty on Net Sales according to the terms of this section. The royalty set forth herein shall be payable on a country-by-country basis for the longer
of: (a) fifteen (15) years from the date of the First Commercial Sale of such Licensed Product in such country; (b) until the last to expire of any Licensed Patents included within the Licensed Technology in such country; (c) the expiration
of Regulatory Exclusivity in such country; and (d) the expiration of Licensed Product’s orphan drug status, if any, in such country.
|
6.3.1. |
18% on the portion of aggregate Net Sales of all countries in the Territory equal to or less than US $[***] in a Calendar Year;
|
6.3.2. |
20.5% the portion of aggregate annual Net Sales of all countries in the Territory between US $[***] and US $[***] in a Calendar Year; and
|
6.3.3. |
23% on the portion of aggregate Net Sales of all countries in the Territory above US $[***] in a Calendar Year.
|
6.4. |
No Adjustments. Ayrmid may not make deductions or offsets from payments to BioLine except as expressly provided in this Agreement.
|
7. |
Royalty Reports; Payments; Records.
|
7.1. |
Royalty Reports. Commencing on the first Calendar Quarter in which Ayrmid, any party acting on its behalf, any Sublicensee or any Affiliate receives Net Sales (including, for the avoidance of doubt,
Reduced-Royalty Net Sales), Ayrmid shall deliver to BioLine within [***] days after the conclusion of each Calendar Quarter, a report containing the following information:
|
7.1.1. |
the quantity of Licensed Products or New Development Products (including, for the avoidance of doubt, Reduced-Royalty New Development Products) sold by Ayrmid or any party acting on its behalf, its Affiliates or a Sublicensee in each
country for the applicable Calendar Quarter;
|
7.1.2. |
the gross amount billed for the Licensed Products or New Development Products (including, for the avoidance of doubt, Reduced-Royalty New Development Products) sold by Ayrmid or any party acting on its behalf, its Affiliates or a
Sublicensee in each country during the applicable Calendar Quarter;
|
7.1.3. |
a calculation of Net Sales (including, for the avoidance of doubt, Reduced-Royalty Net Sales) for the applicable Calendar Quarter in each country, including a listing of applicable deductions; and
|
7.1.4. |
the total amount payable to BioLine in U.S. dollars on Net Sales (including, for the avoidance of doubt, Reduced-Royalty Net Sales) for the applicable Calendar Quarter, together with the exchange rates used for conversion.
|
7.2. |
Payment. Concurrent with the delivery of each report delivered pursuant to Section 7.1 (meaning, within [***] days after the conclusion of each Calendar
Quarter), Ayrmid shall remit to BioLine all amounts due pursuant to Section 6.3 for the applicable Calendar Quarter. Notwithstanding anything herein to the contrary, (i) the royalties owing to BioLine for the applicable Calendar Quarter shall
be calculated using (x) the royalty rate set forth in Section 6.3.1 and, to the extent applicable, (y), in the case of Reduced-Royalty Net Sales for such Calendar Quarter, the Applicable Reduced Royalty Rate, and (ii) in the event the
aggregate Net Sales of all countries in the Territory exceed $[***] in a Calendar Year, Ayrmid shall include in the amounts owing for the last Calendar Quarter of such Calendar Year such additional amounts as are necessary to ensure that
BioLine has, after giving effect to the payment of such additional amounts, received an aggregate amount of royalties for the Calendar Year equal to the amount BioLine would have received had (x) the assessment of the aggregate royalties
owing to BioLine for the Calendar Year been made solely on the basis of the aggregate Net Sales for the entirety of the Calendar Year (and, for the avoidance of doubt, not on a Calendar Quarter-basis) and (y), in connection therewith, the
royalty rates of Sections 6.3.2 and 6.3.3 (as applicable) and, in the case of Reduced-Royalty Net Sales, the Applicable Reduced Royalty Rate(s) (to the extent applicable) been applied to the portions of the aggregate Net Sales for the
Calendar Year applicable thereto.
|
7.3. |
Records; Audit. Ayrmid shall maintain, shall cause its Affiliates to maintain and shall require that its Sublicensees maintain, complete and accurate records of Licensed Products and New Development
Products made, used, marketed and sold under this Agreement, any amounts payable to BioLine in relation to such Licensed Products and New Development Products, which records shall contain sufficient information to permit BioLine to confirm
the accuracy of any reports or notifications delivered under Section 7.1. The relevant party shall retain such records relating to a given Calendar Quarter for at least three (3) years after the conclusion of that Calendar Quarter. During
such three (3) year period, BioLine shall have the right, at BioLine’s expense, to cause an independent, certified public accountant, who is bound by a customary confidentiality arrangement, to inspect Ayrmid’s or its Affiliates’ records
during normal business hours for the purpose of verifying any reports and payments delivered under this Agreement. The parties shall reconcile any underpayment or overpayment within [***] days after the accountant delivers the results of the
audit. In the event that any audit performed under this section reveals an underpayment in excess of [***]% in any Calendar Year, Ayrmid shall bear the full cost of such audit. BioLine may exercise its rights under this Section 7.3 only once
per Calendar Year per audited party and only with reasonable prior notice to the audited party. Ayrmid shall cause its Affiliates to comply with the terms of this Section 7.3.
|
7.4. |
Payment Method. Each payment due to BioLine under this Agreement shall be made by wire transfer of funds to BioLine’s accounts in accordance with written instructions provided by BioLine.
|
7.5. |
Withholding and Similar Taxes. If applicable laws require that taxes be withheld from any amounts due to BioLine under this Agreement, then, for so long as BioLine does not otherwise recover the
withheld amounts (or is not entitled to do so), the sum payable to BioLine will be increased by the amount necessary to ensure that BioLine receives an amount equal to the sum it would have received had Ayrmid made no withholdings or
deductions.
|
8. |
Confidential Information
|
8.1. |
Confidentiality.
|
8.1.1. |
BioLine Confidential Information. Ayrmid agrees that, without the prior written consent of BioLine, in each case, during the term of this Agreement and for a period of 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. Ayrmid 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. Ayrmid may disclose the BioLine Confidential Information only (a) to employees and consultants of Ayrmid or of its Affiliates or
Sublicensees who have a “need to know” such information and are legally bound by agreements which impose confidentiality and non-use obligations comparable to those set forth in this Agreement in order to enable Ayrmid to exercise its rights
or fulfill its obligations under 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 BioLine Confidential Information first enters into a legally binding agreement with Ayrmid which (i) imposes confidentiality and non-use obligations with respect to BioLine Confidential Information comparable to
those set forth in this Agreement; and (ii) such confidentiality and non-use obligations with respect to BioLine Confidential Information last at least 5 years from date of signature of the binding agreement. For purposes of this Agreement, “BioLine Confidential Information” means any 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 and which is disclosed by or on behalf of BioLine or any of its employees or consultants to Ayrmid, whether in oral, written, graphic or machine-readable form, except
to the extent such information: (i) was known to Ayrmid at the time it was disclosed, other than by previous disclosure by or on behalf of BioLine or any of its employees or consultants, as evidenced by Ayrmid’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 Ayrmid’s written records at the time of disclosure; (iii) is lawfully and in good faith
made available to Ayrmid by a third party who Ayrmid reasonably believes is not subject to obligations of confidentiality to BioLine with respect to such information, as evidenced by Ayrmid’s written records at the time of disclosure; or (iv)
is independently developed by Ayrmid without the use of or reference to the BioLine Confidential Information, as demonstrated by documentary evidence.
|
8.1.2. |
Ayrmid Obligation to Take Action. In the event of a breach or threatened breach of any confidentiality agreement between Ayrmid and a third party relating to BioLine Confidential Information, which
would be reasonably understood to have an adverse effect on BioLine, Ayrmid shall immediately notify BioLine thereof and, at the written request of BioLine and at Ayrmid’s expense, use commercial efforts to obtain an injunction or other
similar equitable relief in order to prevent such disclosure of BioLine Confidential Information.
|
8.1.3. |
Ayrmid Confidential Information. BioLine agrees that, without the prior written consent of Ayrmid, in each case, during the term of this Agreement and for 5 years thereafter, it will keep
confidential, and not disclose or use Ayrmid Confidential Information (as defined below) other than for the purposes of this Agreement. BioLine shall treat such Ayrmid 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 Ayrmid Confidential Information only (a) to employees and consultants of BioLine or of its Affiliates who
have a “need to know” such information and are legally bound by agreements which impose confidentiality and non-use obligations comparable to those set forth in this Agreement in order to enable BioLine to exercise its rights or fulfill its
obligations under 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 Ayrmid Confidential Information first enters into a legally binding agreement with BioLine which (i) imposes confidentiality and non-use obligations with respect to Ayrmid Confidential Information comparable to those set
forth in this Agreement; and (ii) such confidentiality and non-use obligations with respect to Ayrmid Confidential Information last at least 5 years from date of signature of the binding agreement. For purposes of this Agreement, “Ayrmid Confidential Information” means any 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 and which is disclosed by or on behalf of Ayrmid pursuant to this Agreement, 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 Ayrmid 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 BioLine
reasonably believes is not subject to obligations of confidentiality to Ayrmid 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 Ayrmid Confidential Information, as demonstrated by documentary evidence.
|
8.1.4. |
BioLine’s Obligation to Take Action. In the event of a breach or threatened breach of any confidentiality agreement between BioLine and a third party relating to Ayrmid Confidential Information,
which would be reasonably understood to have an adverse effect on Ayrmid, BioLine shall immediately notify Ayrmid thereof and, at the written request of Ayrmid and at BioLine’s expense, use commercial efforts to obtain an injunction or other
similar equitable relief in order to prevent such disclosure of Ayrmid Confidential Information.
|
8.2. |
Publicity and Disclosure.
|
8.2.1. |
Notwithstanding anything to the contrary in Section 8.1, Ayrmid may make any announcement, publication, presentation or other disclosure of this Agreement or in relation to the Licensed Product or any New Development or New Development
Products; provided that Ayrmid shall provide the text of any such disclosure (or, to the extent portions of such text do not relate to this Agreement or the Licensed Product, New Development or New
Development Product, such portions of such text that do relate to this Agreement or the Licensed Product, New Development or New Development Product) to BioLine at least [***] days before it is submitted for publication or otherwise disclosed
(“Notice Period”). In the event the applicable disclosure would require BioLine to take action to protect its intellectual property rights or other BioLine Confidential Information, BioLine shall have
an additional [***] days after the expiration of the Notice Period to discuss with Ayrmid and propose modifications or other comments to the disclosure which Ayrmid shall consider in good faith. To the extent applicable after giving effect to
the foregoing sentence, and within [***] days after the expiration of the [***]-day period set forth in the foregoing sentence, BioLine may provide Ayrmid with a written notice (a) requiring the deletion of any BioLine Confidential
Information the announcement, publication, presentation or other disclosure of which pursuant to this Section 8.2.1 would constitute a BioLine MAE or would be reasonably understood to adversely affect BioLine’s rights in and to such BioLine
Confidential Information, in which case Ayrmid shall be required to remove such BioLine Confidential Information as a condition to the making of such announcement, publication, presentation or other disclosure; and (b) requiring the delay of
the making of such announcement, publication, presentation or other disclosure for a period of not more than [***] days from the date of BioLine’s receipt of Ayrmid’s initial written notice solely to ensure that it has made appropriate patent
protection or regulatory exclusivity in respect of the applicable BioLine intellectual property rights implicated by the announcement, publication, presentation or other disclosure. Notwithstanding the foregoing, if applicable laws and
regulations require that an immediate disclosure be made and complying with this Section 8.2.1 is not reasonably possible in the circumstances, Ayrmid may make such disclosure without complying with this Section 8.2.1 provided immediate
written notice thereof (and a description of the surrounding circumstances) is given to BioLine. Except with respect to BioLine’s rights under (a) above, nothing in this Section 8.2.1 shall be read or interpreted so as to provide BioLine with
a consent right over any announcements, publications, presentations or similar disclosures proposed to be made by Ayrmid from and after the end of the Notice Period (as extended in accordance with the foregoing sentences). Announcements,
publications, presentations and other disclosures as contemplated by this Section 8.2.1 shall include disclosures being made to comply with applicable laws (including applicable securities laws and exchange regulations) and to prospective and
current investors and Sublicensees. The Parties agree and acknowledge that, in the event Ayrmid makes an announcement, publication, presentation or other disclosure in accordance with this Section 8.2.1, Ayrmid shall have the right to make
any such announcement, publication, presentation or other disclosure one or more times thereafter without being obligated to comply with the notice, discussion and good faith consideration terms of this Section 8.2.1; provided that any such announcement, publication, presentation or other disclosure must be substantially similar to the initial announcement, publication, presentation or other disclosure made by Ayrmid
in accordance with this Section 8.2.1.
|
8.2.2. |
BioLine may disclose this Agreement to the extent required, in the reasonable opinion of BioLine’s legal counsel, to comply with applicable laws, as well as to prospective and current investors, pursuant to appropriate non-disclosure
arrangements, and to the IIA and its licensors. If BioLine discloses this Agreement or any of the terms hereof in accordance with this Section 8.2.2, BioLine agrees, at its own expense, to seek confidential treatment of portions of this
Agreement or such terms, as may be reasonably requested by Ayrmid. In addition to the foregoing, BioLine may make announcements, publications, presentations and similar disclosures (i) regarding the existence and subject matter of this
Agreement and the royalties paid to BioLine hereunder, (ii) in connection with the marketing or sale of the Licensed Product, as well as any material developments related to the use of the Licensed Product, (iii) in respect of the progress of
the exercise of the Licenses, or (iv) as necessary or required under applicable laws and regulations, including applicable securities laws and exchange regulations; provided, however, that (a) where
mandatory disclosure is made to an exchange or regulatory agency, BioLine shall request confidential treatment of the material so disclosed if possible; and (b) BioLine shall be required to obtain Ayrmid’s prior written consent to specific
wording in such disclosures, which wording and consent shall be provided in English, and which such consent shall not be unreasonably withheld. Notwithstanding the foregoing, if applicable laws and regulations require that an immediate
disclosure be made and obtaining consent as aforesaid is not reasonably possible in the circumstances, BioLine may make such disclosure without consent provided immediate written notice thereof (and a description of the surrounding
circumstances) is given to Ayrmid. Except as provided above, BioLine shall not make any public announcement regarding this Agreement without the prior written consent of Ayrmid, such approval not to be unreasonably withheld.
|
9. |
Infringement.
|
9.1. |
Enforcement of Licensed Technology.
|
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 Technology in the Territory (collectively, an “Infringement”), that Party shall promptly notify the other Party and provide it with details regarding such Infringement.
|
9.1.2. |
Suit by the Controlling Party. Ayrmid shall have the right, but not the obligation, to act in the prosecution, prevention, or termination of any Infringement concerning the Licensed Use Patents and
shall be the Controlling Party in that respect. BioLine shall have the right, but not the obligation, to act in the prosecution, prevention, or termination of any Infringement concerning any Licensed Technology aside from the Licensed Use
Patents and shall be the Controlling Party in that respect. Should the actions in an Infringement or a series of Infringements include the violation of Licensed Use Patents as well as other Licensed Technology, and taking a separate suit or
action against such Infringement(s) is not practical or reasonably possible given the circumstances of the Infringement(s) or applicable law, then BioLine shall have the right, but not the obligation, to act in the prosecution, prevention, or
termination of any such Infringement/s and shall be the Controlling Party in that respect. Should the Controlling Party elect to bring suit against an infringer and the Non-Controlling Party is joined as party plaintiff in any such suit, the
Non-Controlling Party shall have the right to approve or reject the counsel selected by the Controlling Party to represent the Controlling Party and the Non-Controlling Party, such approval not to be unreasonably withheld. The expenses of
such suit or suits that the Controlling Party elects to bring, including any reasonable expenses of the Non-Controlling Party incurred in conjunction with actions requested by the Controlling Party in connection with the prosecution of such
suits or the settlement thereof, shall be paid for entirely by the Controlling Party and the Non-Controlling Party shall hold the Non-Controlling Party free, clear, and harmless from and against any and all costs of such litigation, including
reasonable attorneys’ fees. The Controlling Party shall not compromise or settle such litigation without the prior written consent of the Non-Controlling Party, which consent shall not be unreasonably withheld or delayed. In the event the
Controlling Party exercises its right to sue pursuant to this Section 9.1.2, the sums recovered in such suit or in settlement thereof shall be distributed as follows: (i) to the Controlling Party, as reimbursement for all costs and expenses
reasonably incurred in the prosecution of such suit, including reasonable attorneys’ fees; and (ii), after the distribution of all such amounts owing to the Controlling Party pursuant to (i) above, to the extent of any remaining amounts, (A)
in the event the Infringement is with respect to or otherwise involves the Field, [***]% of such remaining amounts shall be distributed to Ayrmid and [***]% of such remaining amounts shall be distributed to BioLine and (B) in the event the
Infringement is not with respect to or does not otherwise involve the Field, [***]% of such remaining amounts shall be distributed to BioLine.
|
9.1.3. |
Suit by the Non-Controlling Party. If the Controlling Party does not act 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 [***] days after receipt of notice to the Controlling Party by the Non-Controlling Party of the existence of an Infringement, the Non-Controlling Party may
elect to do so and it shall be considered as the Controlling Party for the purposes of Section 9.1.2 above which shall apply to it, mutatis mutandis.
|
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 another Party for
Infringement.
|
9.1.5. |
Cooperation. Each Non-Controlling Party agrees to cooperate fully in any action under this Section 9 which is controlled by the Controlling Party, provided that the Controlling Party reimburses the
Non-Controlling Party promptly for any costs and expenses incurred by the Non-Controlling 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 shall do so at the request of and at the reasonable expense
of the requesting Party. If a Party determines that it is necessary or desirable for the other Party to join any such suit, action or proceeding, the other Party shall execute all papers and perform such other acts as may be reasonably
required in the circumstances.
|
9.2. |
Legal Action against a Party. Each Party will provide the other Party with prompt written notice of any action, suit or proceeding brought against it, 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 Licensed Technology, and the Parties shall
consult in good faith regarding the optimal manner in which to respond to such action, suit or proceeding.
|
10. |
Representations and Warranties; Limitation of Liability.
|
10.1. |
Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as of the License Effective Date as follows:
|
10.1.1. |
Such Party (i) has the authority and legal right to enter into this Agreement and perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder.
|
10.1.2. |
This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights.
|
10.1.3. |
The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable law or any provision of the articles of incorporation, bylaws or any
similar instrument of such Party, as applicable, and (b) do not conflict with, violate, or breach or constitute a default or require any consent not already obtained under, any contractual obligation or court or administrative order by which
such Party is bound.
|
10.2. |
Representations and Warranties by BioLine. BioLine represents and warrants (and, in the case of Section 10.2.2 below, covenants) to Ayrmid as of the License Effective Date that:
|
10.2.1. |
BioLine owns and/or Controls the Licensed Technology, the Licensed Product and the Licensed Trademarks exclusively and, except as set forth in Schedule 10.2, they are all free of encumbrances, and,
except for the Upstream Licensor, no third party has any claim of ownership or right to any of the Licensed Product, the Licensed Technology or the Licensed Trademarks in the Field and in the Territory (including, for the avoidance of doubt,
claim of ownership or right to the Commercialization thereof or any profits or other amounts derived from such Commercialization). Accordingly, to BioLine’s best knowledge, none of (i) Merck Sharp & Dohme B.V., (ii) Kyoto University,
(iii) Hadasit Medical Research Services & Development Ltd. or (iv) any Affiliates of any of the foregoing (i) through (iii) have any claim or ownership or right to any of the Licensed Product, the Licensed Technology or the Licensed
Trademarks (including, for the avoidance of doubt, claim of ownership or right to the Commercialization thereof or any profits or other amounts derived from such Commercialization). Furthermore, with respect to any rights of first offer,
rights of first negotiation or similar rights in respect of the Licensed Product, the Licensed Technology or the Licensed Trademarks arising from either of the Upstream License or the Gloria Agreement (including, for the avoidance of doubt,
the rights of the Upstream Licensor set forth in Section 2.3.2 of the Upstream License and the rights of Gloria set forth in Section 2.7 of the Gloria Agreement), either (x) BioLine has obtained the waiver by the Upstream Licensor and Gloria
of any such rights in full or (y) such rights have lapsed in full as a result of BioLine’s satisfaction of the notice requirements contemplated thereby and the expiration of any response or negotiation periods arising thereafter, in the case
of each of (x) or (y), with respect to the Licenses and other transactions contemplated by this Agreement.
|
10.2.2. |
BioLine has received the written consent of the IIA to the grant of the Licenses contemplated by this Agreement (the “IIA Consent”) and covenants and agrees to comply in all respects with its
applicable obligations and undertakings thereunder.
|
10.2.3. |
BioLine has not granted rights in or to the Licensed Technology, the Licensed Product or the Licensed Trademarks that are inconsistent with the rights granted to Ayrmid under this Agreement.
|
10.2.4. |
BioLine has the right to grant the Licenses granted pursuant to this Agreement free of encumbrances.
|
10.2.5. |
To BioLine’s knowledge, no past or current products, services or activities of BioLine or its Affiliates, licensors (including, for the avoidance of doubt, the Upstream Licensor) or sublicensees involving the Licensed Product, the
Licensed Technology or the Licensed Trademarks have infringed or violated any intellectual property rights of a third party, and, to BioLine’s knowledge, Ayrmid’s licenses to the Licensed Product, the Licensed Technology and the Licensed
Trademarks, as well as Ayrmid’s Commercialization of the Licensed Product, will not infringe or violate any of the intellectual property rights of a third party.
|
10.2.6. |
To BioLine’s knowledge, no third party is presently infringing on any of the Licensed Product, the Licensed Technology or the Licensed Trademarks in a way that is expected to have a material adverse effect on the Licenses granted pursuant
to this Agreement or on Ayrmid’s right or ability to Commercialize the Licensed Product.
|
10.2.7. |
BioLine has taken commercially reasonable measures to maintain and protect all confidential information and trade secrets of BioLine relating to the Licensed Product, the Licensed Technology and the Licensed Trademarks, and, including, to
BioLine’s knowledge, as to BioLine’s Affiliates, licensors (including, for the avoidance of doubt, the Upstream Licensor), sublicensees or manufacturers, there has been no unlawful, accidental or unauthorized access to or use or disclosure of
any of the foregoing.
|
10.2.8. |
Except as set forth in Schedule 10.2, there is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or, to BioLine’s knowledge, currently threatened (i)
against BioLine or any officer or director of BioLine arising out of their employment or Board of Directors relationship with BioLine; (ii) to BioLine’s knowledge, that questions the validity of the Licenses or Ayrmid’s right or ability to
Commercialize the Licensed Product; or (iii) that would reasonably be expected to have, either individually or in the aggregate, a material adverse effect on the Licenses or Ayrmid’s right or ability to Commercialize the Licensed Product.
|
10.2.9. |
BioLine is and has been in material compliance with, and, to BioLine’s knowledge, all of BioLine’s Affiliates, licensors (including, for the avoidance of doubt, the Upstream Licensor), sublicensees and manufacturers are and have been in
material compliance with, all applicable laws administered or issued by the U.S. Food and Drug Administration or any similar Regulatory Agency and all other applicable laws regarding developing, testing, manufacturing, complaint handling,
adverse event reporting, marketing, distributing or promoting the Licensed Product and the Licensed Technology. BioLine and, to BioLine’s knowledge, its Affiliates, licensors (including, for the avoidance of doubt, the Upstream Licensor),
sublicensees and manufacturers (i) possess and have possessed all required permits, licenses, registrations, certificates, authorizations, orders, exemptions, clearances and approvals from the appropriate Regulatory Agencies as are and have
been required for each of their respective activities in relation to the Licensed Product and the Licensed Technology and (ii) have not received any notice of proceedings relating to the suspension, material modification, revocation or
cancellation of any such permit, license, registration, certificate, authorization, order or approval.
|
10.3. |
Representations and Warranties by Ayrmid. Ayrmid represents and warrants to BioLine that its business is in good standing and complies with all applicable local, state, and international laws and
regulations.
|
10.4. |
Compliance with Law. Ayrmid undertakes that it will comply with all laws and regulations in the Territory applicable to the Commercialization of the Licensed Product.
|
10.5. |
No Warranty. Except as otherwise expressly provided in this Agreement, neither Party makes any representation or warranty, express or implied, with respect to any technology, patents, goods,
services, rights or other subject matter of this Agreement.
|
10.6. |
Limitation of Liability. Notwithstanding anything else in this Agreement or otherwise and to the maximum extent permitted under applicable law, neither BioLine nor Ayrmid will be liable to the other
with respect to any subject matter of this Agreement for (i) any indirect, incidental, special, consequential, or punitive damages or lost profits or (ii) cost of procurement of substitute goods, technology or services. The foregoing
limitations shall not apply in the case of (i) the intentional breach, willful misconduct and/or fraud of a Party, (ii) a breach by BioLine of the exclusivity obligations imposed upon it in Sections 2.2 and 2.3 of this Agreement and (iii)
with respect to a Party’s indemnification obligations hereunder.
|
11. |
Indemnification; Insurance.
|
11.1. |
Indemnity in Favor of BioLine.
|
11.1.1. |
Ayrmid shall indemnify, defend, and hold harmless BioLine and its licensors, and their respective directors, officers, employees, agents and successors, heirs and permitted assigns (the “BioLine Indemnitees”),
from and against any liability, damage, loss, or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon any of the BioLine Indemnitees in connection with any third party 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) to the extent such Claims result from or
are based on (i) a breach of this Agreement by Ayrmid; (ii) the use of any Licensed Technology or New Developments by Ayrmid, or any of its Affiliates or Sublicensees, or (iii) any product, process, or service that is made, used, or sold by
Ayrmid or any of its Affiliates or Sublicensees pursuant to any right or license granted by BioLine to Ayrmid under this Agreement. The foregoing indemnification obligation will not apply to any Claim to the extent it arises directly out of a
BioLine Indemnitee’s breach of this Agreement, fraud, negligence, willful misconduct or is otherwise covered by BioLine’s indemnification obligations under Section 11.2 below.
|
11.1.2. |
Procedures. If any BioLine Indemnitee receives notice of any Claim, BioLine shall, as promptly as is reasonably possible, give Ayrmid written notice of such Claim; provided,
however, that failure to give such notice promptly shall only relieve Ayrmid of any indemnification obligation it may have hereunder to the extent such failure materially prejudices the ability of Ayrmid to respond to or to defend
the BioLine Indemnitee against such Claim. BioLine and Ayrmid shall consult and cooperate with each other regarding the response to and the defense of any such Claim and Ayrmid shall, upon its acknowledgment in writing of its obligation to
indemnify the BioLine Indemnitee, be entitled to and shall assume the defense or represent the interests of the BioLine 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 BioLine Indemnitee and to propose, accept or reject offers of settlement, all at its sole cost; and provided, further, that where any such settlement impacts
upon any of BioLine’s rights, involves any admission of liability by BioLine or any of the BioLine Indemnitees, or involves any other obligation or undertaking on the part of BioLine or any of the BioLine Indemnitees, BioLine’s written
consent shall be required, such consent not to be unreasonably withheld. Nothing herein shall prevent any BioLine Indemnitee from retaining its own counsel and participating in its own defense at its own cost and expense.
|
11.2. |
Indemnity in Favor of Ayrmid.
|
11.2.1. |
BioLine shall indemnify, defend, and hold harmless Ayrmid, its directors, officers, employees and agents and their respective successors, heirs and assigns (the “Ayrmid Indemnitees”), from and
against any liability, damage, loss, or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon any of the Ayrmid Indemnitees in connection with any third party Claims arising out of any theory of
liability (including without limitation actions in the form of tort, warranty, or strict liability) to the extent such Claims result from or are based on (i) a breach of this Agreement by BioLine; (ii) any product, process or service that is
made, used or sold by BioLine in connection with any right or license granted by BioLine to Ayrmid under this Agreement, excepting the New Developments; and (iii) the fraud, gross negligence or willful misconduct on the part of any of the
BioLine Indemnitees with respect to the Licensed Product, New Developments or the Licensed Technology. The foregoing indemnification obligation will not apply to any Claim to the extent it arises directly out of an Ayrmid Indemnitee’s breach
of this Agreement, fraud, negligence, willful misconduct or is otherwise covered by Ayrmid’s indemnification obligations under Section 11.1 above.
|
11.2.2. |
Procedures. If any Ayrmid Indemnitee receives notice of any Claim, Ayrmid shall, as promptly as is reasonably possible, give BioLine written 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 materially prejudices the ability of BioLine to respond to or to defend
the Ayrmid Indemnitee against such Claim. Ayrmid 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 Ayrmid Indemnitee, be entitled to and shall assume the defense or represent the interests of the Ayrmid 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 Ayrmid Indemnitee and to propose, accept or reject offers of settlement, all at its sole cost; and provided, further, that where any such settlement impacts
upon any of Ayrmid’s rights, involves any admission of liability by Ayrmid or any of the Ayrmid Indemnitees, or involves any other obligation or undertaking on the part of Ayrmid or any of the Ayrmid Indemnitees, Ayrmid’s written consent
shall be required, such consent not to be unreasonably withheld. Nothing herein shall prevent the Ayrmid Indemnitee from retaining its own counsel and participating in its own defense at its own cost and expense.
|
11.3. |
Insurance. Each Party shall obtain and maintain, at its expense, appropriate insurance to cover its respective activities under this Agreement, but in no event shall such coverage be less than any
legally required amount. Each Party shall deliver to the other Party, promptly following request, certificates of insurance that evidence insurance coverage as aforesaid.
|
12. |
Certain Deliveries; Transfers.
|
12.1. |
BioLine License Effective Date Deliveries. On the License Effective Date, BioLine will deliver, or cause to be delivered (as applicable), to Ayrmid the following:
|
12.1.1. |
A Manufacturing and Supply Agreement (the “Supply Agreement”), duly executed by BioLine;
|
12.1.2. |
A Transition Services Agreement, duly executed by BioLine;
|
12.1.3. |
A Confirmation of Continuity, duly executed by BioLine and the Upstream Licensor (the “Biokine Letter Agreement”);
|
12.1.4. |
A Consent to License Agreement, duly executed by BioLine and Kreos Capital VII Aggregator SCSp (“Kreos”, and such Consent to License Agreement, the “Kreos Consent”);
and
|
12.1.5. |
Written evidence of the IIA Consent.
|
12.2. |
Ayrmid License Effective Date Deliveries. On the License Effective Date, Ayrmid will deliver, or cause to be delivered (as applicable), to BioLine the following:
|
12.2.1. |
The Supply Agreement, duly executed by Ayrmid;
|
12.2.2. |
A Transition Services Agreement, duly executed by Ayrmid; and
|
12.2.3. |
The Biokine Letter Agreement, duly executed by Ayrmid.
|
12.3. |
Transfer of Distribution Agreements. Unless assigned and/or transferred (as applicable) to Ayrmid prior to the License Effective Date, within [***] days after the License Effective Date, BioLine
shall use reasonable best efforts to assign the following agreements (in each case, including all amendments, modifications and supplements thereto) to Ayrmid: (i) [***].; (ii) [***]; (iii[***]; (iv) [***]; and (v) [***] (each of (i), (ii),
(iii), (iv) and (v), a “Distribution Agreement”, and each entity providing services pursuant thereto, a “Distributor”). Ayrmid shall reasonably cooperate with
BioLine in executing and delivering such documents and instruments as are reasonably necessary to effectuate the foregoing transfer; provided that, in no event shall Ayrmid be required to take any action that would reasonably be expected (in
Ayrmid’s sole discretion) to adversely affect Ayrmid’s Commercialization of the Licensed Product. In the event that, after using reasonable best efforts, BioLine is unable to effectuate the foregoing transfer of a Distribution Agreement,
BioLine shall use reasonable best efforts to cooperate with Ayrmid in facilitating a new written agreement (x) between Ayrmid and such Distributor on substantially the same terms and conditions as exist in the applicable Distribution
Agreement or (y), in the event Ayrmid (in its reasonable discretion) and/or such Distributor refuse to enter into such a written agreement, between Ayrmid and a third party that can provide substantially similar services as were being
provided by the applicable Distributor under the applicable Distribution Agreement. During such time as the Parties are using the applicable efforts to give effect to this Section 12.3, BioLine shall use reasonable best efforts to ensure that
Ayrmid is able to exercise the rights of BioLine and access the services of each Distributor, in each case, under each Distribution Agreement as if Ayrmid were BioLine thereunder (the foregoing exercise of rights by Ayrmid, “Interim Use”). With respect to any costs, expenses or similar obligations arising from Distribution Agreements that are assigned and/or transferred, or that are intended to be assigned and/or transferred,
to Ayrmid pursuant to this Section 12.3 (including, for the avoidance of doubt, costs, expenses or similar obligations arising from Interim Use), the Parties agree and acknowledge that Ayrmid shall be liable for such costs, expenses or
similar obligations only to the extent arising from its exercise of its rights under any such Distribution Agreements (including, for the avoidance of doubt, Interim Use) from and after the License Effective Date, and BioLine shall be liable
for any costs, expenses or similar obligations that arise from and after the License Effective Date solely to the extent relating to matters in respect of the Distribution Agreements occurring prior to
the License Effective Date. For clarity, in the event of Interim Use of any Distribution Agreement by Ayrmid, Ayrmid shall be obligated to make payment (including, as the context dictates, as reimbursement to BioLine for payments made by
BioLine on Ayrmid’s behalf) for the applicable costs, expenses and similar obligations arising from such Interim Use and shall indemnify and hold BioLine harmless from and against any and all liabilities, damages, losses or expenses
(including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon BioLine resulting from or based on such Interim Use. Notwithstanding anything to the contrary herein, in no event shall the foregoing obligation to
indemnify and hold BioLine harmless apply to any liabilities, damages, losses or expenses (including reasonable attorneys’ fees and expenses of litigation) to the extent arising out of (i) a breach by BioLine of the applicable Distribution
Agreement or (ii) the fraud, negligence or willful misconduct of BioLine.
|
12.4. |
Transfer of MA and Interim Right of Reference.
|
12.4.1. |
BioLine shall take, or cause to be taken, all actions, and shall do, or cause to be done, all things, in each case, necessary, proper or advisable (including, for the avoidance of doubt, the execution and/or filing of all required forms
and documents, and prompt responses to all inquiries raised by the FDA (as defined below)) to assign to Ayrmid, within [***] days after the License Effective Date, that certain NDA Approval #217159 received from the U.S. Food and Drug
Administration (the “FDA”) on September 8, 2023 (the “MA”) filed for marketing approval of the Licensed Product to Ayrmid, free of encumbrances, in accordance
with all applicable laws (including applicable Regulatory Approvals), and Ayrmid shall reasonably cooperate with BioLine in connection therewith.
|
12.4.2. |
With respect to the period of time in which the transfer of the MA has not been consummated (including, for the avoidance of doubt, in the event, after taking the requisite efforts contemplated by this Section 12.4, the transfer of the MA
is unable to be taken), BioLine hereby grants to Ayrmid (and, to the extent applicable, its Affiliates, Sublicensees and distributors) a right to reference, file, or incorporate by reference any Regulatory Approvals (including, without
limitation, the MA) to the extent necessary or reasonably desirable for Ayrmid to Commercialize the Licensed Product in the Territory.
|
12.4.3. |
In the event that the transfer of the MA to Ayrmid is consummated in accordance with Section 12.4.1, the Parties agree and acknowledge that (i) to the extent that BioLine acts as the marketing authorization holder for the Licensed Product
in any jurisdiction outside the Territory (in such capacity, a “Non-Territory MA Holder”), Arymid shall provide any documentation regarding the MA that BioLine
may reasonably require for such purpose, and (ii) in the event that (x) Ayrmid is required to serve as a Non-Territory MA Holder in [***]or [***]or other countries in the Gloria Territory (each, a “Specified
Non-Territory Jurisdiction”) so as to prevent the occurrence of breach by BioLine of the Gloria Agreement or a material adverse event to Gloria’s rights arising thereunder (including, for the avoidance of doubt, its rights to
commercialize the Licensed Product) (it being understood and clarified that, in addition to the prevention of the occurrence of a BioLine MAE, Ayrmid shall be required to so serve as a Non-Territory MA Holder in a Specified Non-Territory
Jurisdiction only after BioLine has used best efforts to discuss and agree with Gloria to having Gloria serve as the Non-Territory MA Holder in such Specified Non-Territory Jurisdiction and, after giving effect to such discussions, it has
been determined that having Gloria serve as the Non-Territory MA Holder in such Specified Non-Territory Jurisdiction would violate the applicable laws of such Specified Non-Territory Jurisdiction) and (y) BioLine requests in writing that
Ayrmid be the Non-Territory MA Holder for such Specified Non-Territory Jurisdiction, the Parties shall use reasonable best efforts to make Ayrmid the Non-Territory MA Holder for such Specified Non-Territory Jurisdiction (including, to the
extent applicable, reasonable best efforts to assign the marketing authorization for such Specified Non-Territory Jurisdiction to Ayrmid on substantially the terms set forth in Section 12.4.1 above (on a mutatis
mutandis basis)) (the foregoing, a “Non-Territory MA Holder Assumption”); provided that, in the case of a Non-Territory MA Holder Assumption, BioLine
agrees to (i) indemnify and hold the Ayrmid Indemnitees harmless from and against any and all liabilities, damages, losses or expenses (including reasonable attorneys’ fees and expenses of litigation) (x) incurred by or imposed upon the
Ayrmid Indemnitees and (y) resulting from or based on (A) the efforts and actions taken by the Parties in connection with the Non-Territory MA Holder Assumption or (B) Ayrmid’s status as a Non-Territory MA Holder and/or any obligations
arising therefrom (the foregoing, the “MA Indemnity”), and (ii) enter into and consummate, and use its best efforts to require Gloria to enter into and consummate, a written agreement by and among the
Parties and Gloria pursuant to which Gloria agrees to indemnify and hold the Ayrmid Indemnitees harmless on terms that are substantially similar to the MA Indemnity.
|
12.5. |
Filing of Executed Agreement with IIA. BioLine undertakes to file a fully-executed version of this Agreement with the IIA within two (2) calendar days of the License Effective Date.
|
13. |
Term and Termination.
|
13.1. |
Term. The term of this Agreement shall commence on the License Effective Date and, unless earlier terminated as provided in this Section 13, shall continue in full force and effect on a
country-by-country basis in the Territory until the expiration of all payment obligations pursuant to Section 6.
|
13.2. |
Termination.
|
13.2.1. |
Termination for Default.
|
13.2.1.1. |
In the event that Ayrmid commits a Material Breach of this Agreement and fails to cure that breach within [***] days after receiving written notice thereof from BioLine, BioLine may terminate this Agreement immediately upon written notice
to Ayrmid. Notwithstanding the foregoing, in the event that any breach is reasonably able to be cured within the stated period and Ayrmid uses diligent good faith efforts to cure such breach, then the stated period will be extended by an
additional [***] days. Notwithstanding anything to the contrary herein, in the event Ayrmid commits a Material Breach of Section 5.1.1 hereof by failing to use Commercially Reasonable Efforts to Commercialize the Licensed Product within some,
but not all, of the CRE Jurisdictions and fails to cure such breach within [***] days after receiving written notice thereof from BioLine, (a “CRE Jurisdiction Breach”) BioLine shall have the right to
partially terminate this Agreement only as to the applicable CRE Jurisdictions in which such CRE Jurisdiction Breach occurred, such that, after giving effect to such partial termination, the term “Territory” herein shall be read and
interpreted to exclude the applicable CRE Jurisdictions (any such CRE Jurisdiction thereafter, an “Excluded CRE Jurisdiction”). For the avoidance of doubt, in the event of a CRE Jurisdiction Breach, and
notwithstanding anything to the contrary in this Agreement, BioLine shall have the right to Commercialize the Licensed Product in the Excluded CRE Jurisdiction (directly or via third parties) and shall be entitled to make use of the Licensed
Technology and Licensed Trademarks (and have access to all applicable regulatory files) in the Excluded CRE Jurisdiction and grant licenses or rights to third parties under such rights for such Commercialization; provided, however, that BioLine shall use, shall cause its Affiliates to use and shall require that all such third parties to which such licenses or rights are granted use Commercially Reasonable Efforts in ensuring that the
Commercialization of the Licensed Product and the use of the Licensed Technology and Licensed Trademarks (and applicable regulatory files) in the Excluded CRE Jurisdiction does not have an adverse effect on the Commercialization of the
Licensed Product by Ayrmid in other jurisdictions in the Territory.
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13.2.1.2. |
In the event that BioLine commits a Material Breach of this Agreement and fails to cure that breach within [***] days after receiving written notice thereof from Ayrmid, Ayrmid may terminate this Agreement immediately upon written notice
to BioLine. Notwithstanding the foregoing, in the event that any breach is reasonably able to be cured within the stated period and BioLine uses diligent good faith efforts to cure such breach, then the stated period will be extended by an
additional [***] days. Notwithstanding anything to the contrary herein, other than as expressly permitted by this Agreement (including, as applicable, with respect to an Excluded CRE Jurisdiction) or the agreements set forth in Section 12,
(i) the engagement by BioLine in the Commercialization of the Licensed Product (whether directly or indirectly) in the Field in the Territory, (ii) the granting by BioLine of any of the rights or licenses granted to Ayrmid hereunder, whether
to a third party or an Affiliate, in the Field in the Territory and (iii) the breach by BioLine of Section 10.2.2 (whether in whole or in part), shall, in each case, be considered a Material Breach by BioLine of this Agreement.
|
13.2.2. |
Bankruptcy.
|
13.2.2.1. |
Either Ayrmid or BioLine 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 [***] days, or if the other Party becomes the subject of liquidation or dissolution proceedings (other than in the context of a solvent internal restructuring), admits in writing its inability to pay its debts or
otherwise discontinues business.
|
13.2.2.2. |
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 13.2.2.1 during such period as long as it is not breached in a
material manner.
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13.2.3. |
Termination of the Upstream License. In the event of a termination of any part of the Upstream License for any reason, any element of the Licenses covering Licensed Technology in-licensed by BioLine
from the Upstream Licensor and corresponding to the terminated license shall immediately terminate.
|
13.2.4. |
Notwithstanding anything to the contrary in the foregoing, the Parties agree and acknowledge that, pursuant to and in accordance with the terms and conditions of the Biokine Letter Agreement, Ayrmid shall have the right to enter into a
direct license agreement with the Upstream Licensor.
|
13.3. |
Effect of Expiration and Termination.
|
13.3.1. |
Termination of Rights.
|
13.3.1.1. |
Except as may be contemplated by (x) Section 13.2.4 above and the Biokine Letter Agreement and (y) a CRE Jurisdiction Breach, upon expiration of this Agreement pursuant to Section 13.1, or earlier termination by Ayrmid pursuant to Section
13.2.1.2, 13.2.2 or 13.2.3 hereof, or by BioLine pursuant to Sections 13.2.1.1, 13.2.2 or 13.2.3 hereof: (a) the rights and Licenses granted to Ayrmid under Section 2 shall terminate; (b) all rights in and to the Licensed Technology and the
Licensed Trademarks and any documents concerning work product generated with respect thereto shall revert to BioLine, and Ayrmid shall not be entitled to make any further use whatsoever of the Licensed Technology, the Licensed Trademarks or
such documents nor shall Ayrmid further Commercialize the Licensed Product; and (c) any existing agreements that contain a Sublicense of the Licensed Technology shall terminate. In addition, following any expiration or termination as
aforesaid, each Party will return or cause to be returned to the other Party, or destroy or have destroyed any BioLine Confidential Information or Ayrmid Confidential Information, as applicable, of the other Party, and without limiting the
foregoing, Ayrmid shall make Commercially Reasonable Efforts to deliver to BioLine any documents or other materials relating to work performed with respect to its obligations in Section 5.1 or to business development or commercial contacts
with respect to the Licensed Technology or Licensed Product (except as may be with respect to any Reduced-Royalty New Development Product). A recipient of BioLine Confidential Information or Ayrmid Confidential Information (as applicable)
shall however be entitled to retain one copy of such BioLine Confidential Information or Ayrmid Confidential Information (as applicable) in a secure manner in its legal files for the purpose of determining its obligations under this
Agreement.
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13.3.1.2. |
Notwithstanding anything to the contrary in the foregoing Section 13.3.1.1, in the event of the expiration of this Agreement pursuant to Section 13.1 or the exercise by Ayrmid of its rights under Section 13.2.4 above and the Biokine Letter
Agreement, BioLine shall, upon written request from Ayrmid, grant to Ayrmid a non-exclusive, fully paid up and royalty-free, non-transferable but sublicensable license in and to the Licensed Trademarks on substantially the terms set forth in
Section 2.2, mutatis mutandis (except for any such terms that impose or otherwise constitute a restriction on the right of Ayrmid to sublicense the license to the Licensed Trademarks granted pursuant
to this Section 13.3.1.2).
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13.3.1.3. |
Notwithstanding anything to the contrary in the foregoing Section 13.3.1.1, in the event (x) Ayrmid has any New Developments or New Development Products (including, for the avoidance of doubt, Reduced-Royalty New Development Products) and
(y) this Agreement expires pursuant to Section 13.1 (herein, an “Expiration”), or is terminated by Ayrmid pursuant to Sections 13.2.1.2 (herein, an “Ayrmid Termination”), or by BioLine pursuant to Sections 13.2.1.1 (herein, a “BioLine
Termination”) , BioLine shall, upon written request from Ayrmid, grant to Ayrmid a non-exclusive, non-transferable but sublicensable license in and to the Licensed Technology on substantially the terms set forth in Section 2.1, mutatis mutandis, solely to the extent required for Ayrmid’s Commercialization of such New Developments or New Development Products (including, for the avoidance of doubt, Reduced-Royalty New Development
Products) in the Field in the Territory; provided, however, that (i) in the event of an Expiration, the foregoing license shall be on a fully paid up and royalty-free basis; (ii) in the event of an
Ayrmid Termination, the foregoing license shall be subject to payment of royalties to BioLine at [***]% of the rates set out in Section 6.3; and (iii) in the event of a BioLine Termination, the foregoing license shall be subject to payment of
royalties to BioLine at the rates set out in Section 6.3.
|
13.3.2. |
Transfer of Filings and New Developments. In the event BioLine terminates this Agreement pursuant to Section 13.2.1.1 (except for a CRE Jurisdiction Breach) or 13.2.2,
|
13.3.2.1. |
Ayrmid shall deliver, transfer and assign to BioLine, and, to the extent applicable, shall cause all of its Affiliates and shall use Commercially Reasonable Efforts to cause its Sublicensees to deliver, transfer and assign to BioLine, in
each case, to the extent transferable, the following as well as all rights, title and interest thereto: all documents and other materials filed by or on behalf of Ayrmid and its Affiliates (but not including Sublicensees unless Ayrmid is
entitled to receive such documents and materials from a Sublicensee upon termination of the applicable Sublicense) with Regulatory Agencies in furtherance of applications for Regulatory Approval in the Territory with respect to Licensed
Product;
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13.3.2.2. |
(i) Ayrmid shall grant, and, to the extent applicable, shall cause all of its Affiliates and shall use Commercially Reasonable Efforts to cause its Sublicensees to grant, to BioLine a non-exclusive,
fully paid up and royalty-free, transferable and sublicensable license in and to the New Developments (but excluding any Reduced-Royalty New Development Products) to research, have researched, Develop, have Developed, manufacture and have
manufactured, and Commercialize such New Developments (but excluding, for the avoidance of doubt, any Reduced-Royalty New Development Products), and (ii) Arymid shall execute, and, to the extent applicable, shall cause its Affiliates and
shall use Commercially Reasonable Efforts to cause its Sublicensees to execute, any reasonably required documents that BioLine may reasonably request be executed to give effect to the foregoing; and
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13.3.2.3. |
Ayrmid shall grant, and, to the extent applicable, shall cause all of its Affiliates and shall use Commercially Reasonable Efforts to cause its Sublicensees to grant, to BioLine for two (2) years following the date of termination of this
Agreement the following right of first negotiation: in the event Ayrmid wishes to grant to a third party an exclusive, worldwide, royalty-bearing, license in relation to part or all of its New
Developments (including, for these purposes, any Reduced-Royalty New Development Products) to research, have researched, Develop, have Developed, manufacture and have manufactured, and Commercialize such New Developments (including, for these
purposes, any Reduced-Royalty New Development Products) (an “Exclusive License Arrangement”), prior to entering into negotiations or discussions with any such third party as to such Exclusive License
Arrangement (it being clarified that Ayrmid’s receipt of a notice, offer or summary of terms from a third party in respect of an Exclusive License Arrangement that is not solicited by Ayrmid shall not, in and of itself, be considered the
entering into of negotiations or discussions by Ayrmid with such third party), Ayrmid shall notify BioLine of its wish to enter into such Exclusive License Arrangement and the applicable terms thereof (the “Exclusive
License Arrangement Notice”). BioLine shall thereafter have [***] days to consider whether it is interested in entering into the Exclusive License Arrangement on the terms set forth in the Exclusive License Arrangement Notice and, if
it is, BioLine shall notify Ayrmid thereof (the “Exclusive License Arrangement Response”). Upon receipt of the Exclusive License Arrangement Response, Ayrmid and BioLine shall engage in good faith
negotiations in respect of the Exclusive License Arrangement. Should (i) BioLine fail to provide the Exclusive License Arrangement Response within the aforementioned [***] day period, (ii) BioLine otherwise notify Ayrmid that it is not
interested in entering into the Exclusive License Arrangement, or (iii) the Parties fail to consummate the Exclusive License Arrangement within [***] days of BioLine having provided the Exclusive License Arrangement Response, Ayrmid shall, in
the case of each of (i), (ii) and (iii), be free to enter into negotiations or other discussions with any third party with respect to the Exclusive License Arrangement.
|
13.3.3. |
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.
|
13.4. |
Survival. The Parties’ respective rights, obligations, and duties under Sections 2.3.3.2, 8, 10.5, 10.6, 11, 12.3, 12.4, 13, and 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 BioLine arising from the Commercialization of the Licensed
Product prior to the date of expiration or termination of this Agreement.
|
14. |
Miscellaneous.
|
14.1. |
Entire Agreement. This Agreement, together with the Biokine Letter Agreement and each such other agreement set forth in Section 12, collectively represent the entire agreement of the Parties with
respect to the subject matter hereof, and except as expressly set forth herein or otherwise agreed between the Parties in writing, the agreements set forth in this Agreement, the Biokine Letter Agreement and each such other agreement set
forth in Section 12 collectively supersede all other agreements and understandings between the Parties with respect to same.
|
14.2. |
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 international courier, or
by email, to the following addresses, unless the parties are subsequently notified of any change of address in accordance with this Section 14.2:
|
If to BioLine:
|
BioLineRx Ltd.
Modi’in Technology Park
2 HaMa’ayan Street
Modi’in, 7177871, Israel
Attention: Chief Executive Officer
Email:
|
With a copy (which shall not constitute notice) to:
|
BioLineRx Ltd.
Modi’in Technology Park
2 HaMa’ayan Street
Modi’in, 7177871, Israel
Attention: General Counsel
Email:
|
If to the Ayrmid:
|
Ayrmid Pharma Ltd.
C/o Byrne Wallace
88 Harcourt Street
Dublin 2, Ireland
Attention: Rory Nealon
Email:
|
With a copy (which shall not constitute notice) to:
|
Paul Hastings LLP
200 Park Avenue
New York, NY 10166
Attention: Samuel Waxman
Email:
|
14.3. |
Governing Law and Dispute Resolution.
|
14.3.1. |
This Agreement shall be governed by and construed in accordance with the laws of the State of New-York, without regard to the application of principles of conflicts of law.
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14.3.2. |
Any dispute arising out of or in connection with this Agreement, as well as its validity, shall be first referred to a senior officer of each Party. Such officers shall use good faith efforts to promptly meet and resolve the dispute within
10 business days of the matter being referred to them. In the event such a resolution is not reached within such 10 business day period, the dispute shall be submitted to binding arbitration as set forth in Section 14.3.3 below.
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14.3.3. |
Except as expressly stated otherwise herein, all disputes arising out of or in connection with this Agreement as well as its validity shall be finally settled in accordance with the Rules of Arbitration of the International Chamber of
Commerce (the “ICC Rules”) in force at the time of the dispute. The arbitral tribunal will consist of one (1) arbiter appointed by agreement of the parties or, if such agreement is not obtained within
30 days of request by a party for arbitration, in accordance with the ICC Rules. The seat of the arbitration will be New York, New York. The language of the arbitral proceedings and all documents exchanged and submitted shall be English. The
foregoing shall not derogate from the right of either party to seek injunctive relief from a court of competent jurisdiction.
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14.4. |
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.
|
14.5. |
Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.
|
14.6. |
Counterparts. This Agreement may be executed simultaneously in two or more counterparts, each of which shall be deemed an original.
|
14.7. |
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 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.
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14.8. |
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 agent for the other or as partner with the
other Party or any third party.
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14.9. |
Assignment and Successors. This Agreement may not be assigned, or transferred by operation of law or otherwise, by either Party, without the prior written consent of the other Party, which consent
shall not be unreasonably withheld, conditioned, or delayed, 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 to any successor corporation resulting from any merger or consolidation of such Party with or into such corporation. The assigning or transferring party shall provide reasonable
advance notice of such assignment or transfer to the other party.
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14.10. |
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,
pandemic, flood, war, strike, or riot, or similar significant “acts of god” 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.
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14.11. |
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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14.12. |
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
such provision shall be interpreted as necessary to give maximum effect to such provision as permitted under law and that the remainder of this Agreement shall not be affected.
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14.13. |
Execution. This Agreement may be executed in any number of counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same
document. Signatures to this Agreement transmitted by email in “portable document format” (pdf) or signed electronically by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall
have the same effect as physical delivery of the paper document bearing original signature.
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BioLineRx Ltd.
By: _______________________
Name: _____________________
Title: ______________________
|
Ayrmid Pharma Ltd.
By: __________________________
Name: ________________________
Title: _________________________
|
Project /
Docket No.
|
Owner
Law firm
|
Title
|
Territory
|
Application/ Patent Number
|
Filing Date
|
Status
(Pending
unless stated otherwise)
|
Expiration Date
(without extension)
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Project /
Docket No.
|
Owner
Law firm
|
Title
|
Territory
|
Application/ Patent Number
|
Filing Date
|
Status
(Pending
unless stated otherwise)
|
Expiration Date
(without extension)
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Application Date
|
Country
|
Status
|
Owners
|
Goods/Services
|
Mark
|
International ref No.
|
No.
|
Expiration Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Application Date
|
Country
|
Status
|
Owners
|
Goods/Services
|
Mark
|
International ref No.
|
No.
|
Notes
|
Expiration Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
A. |
The parties to this Amendment (the “Parties”) have entered into the Loan Agreement;
|
B. |
The Parties wish to amend certain terms of the Loan Agreement.
|
1. |
Definitions
|
2. |
Condition Precedent
|
(i) |
Borrower and Ayrmid Pharma Ltd. (“Ayrmid”) executing the license agreement in the form attached hereto as Schedule A-1 (the “License Agreement”);
|
(ii) |
Kreos executing the consent with respect to the License Agreement in the form attached hereto as Schedule A-2 (the “Consent Letter”);
|
(iii) |
Borrower shall have received from Ayrmid the Upfront Payment (as defined in the License Agreement) in the amount $10,000,000;
|
(iv) |
Borrower shall have completed an equity investment round pursuant to which it raised from Ayrmid at least $9,000,000;
|
(v) |
Borrower shall have made a partial loan prepayment to Lender in the amount of $10,000,000 (which includes principal, interest, a pro-rata share of the End of Loan Payment and a pro-rata set-off the Advanced Payment, in relation to such
prepayment);
|
(vi) |
Borrower shall have paid to Lender an additional amount of $6,500,000 in lieu of the Revenue-Based Fee (the “Revenue-Based Payment”).
|
3. |
New Repayment Schedule
|
4. |
Milestone Payments
|
5. |
Minimum Cash Balance
|
6. |
Termination of Revenue-Based Fee
|
7. |
Survival of Provisions
|
8. |
General Provisions
|
8.1. |
Expenses
|
8.2. |
Entire Agreement
|
8.3. |
Counterparts
|
DUE DATE
|
DEPOSIT
|
OTHER
|
CAPITAL
|
INTEREST
|
TOTAL
INFLOWS
|
NET
CASHFLOWS
|
BALANCE
|
13,809,975.49
|
|||||||
01-Dec-24
|
373,242.58
|
109,328.97
|
482,571.55
|
482,571.55
|
13,436,732.91
|
||
01-Jan-25
|
373,242.58
|
106,374.14
|
479,616.72
|
479,616.72
|
13,063,490.33
|
||
01-Feb-25
|
373,242.58
|
103,419.30
|
476,661.88
|
476,661.88
|
12,690,247.75
|
||
01-Mar-25
|
373,242.58
|
100,464.46
|
473,707.04
|
473,707.04
|
12,317,005.17
|
||
01-Apr-25
|
373,242.58
|
97,509.62
|
470,752.21
|
470,752.21
|
11,943,762.59
|
||
01-May-25
|
373,242.58
|
94,554.79
|
467,797.37
|
467,797.37
|
11,570,520.01
|
||
01-Jun-25
|
373,242.58
|
91,599.95
|
464,842.53
|
464,842.53
|
11,197,277.43
|
||
01-Jul-25
|
373,242.58
|
88,645.11
|
461,887.69
|
461,887.69
|
10,824,034.85
|
||
01-Aug-25
|
373,242.58
|
85,690.28
|
458,932.86
|
458,932.86
|
10,450,792.27
|
||
01-Sep-25
|
373,242.58
|
82,735.44
|
455,978.02
|
455,978.02
|
10,077,549.69
|
||
01-Oct-25
|
373,242.58
|
79,780.60
|
453,023.18
|
453,023.18
|
9,704,307.10
|
||
01-Nov-25
|
373,242.58
|
76,825.76
|
450,068.35
|
450,068.35
|
9,331,064.52
|
||
01-Dec-25
|
373,242.58
|
73,870.93
|
447,113.51
|
447,113.51
|
8,957,821.94
|
||
01-Jan-26
|
373,242.58
|
70,916.09
|
444,158.67
|
444,158.67
|
8,584,579.36
|
||
01-Feb-26
|
373,242.58
|
67,961.25
|
441,203.83
|
441,203.83
|
8,211,336.78
|
||
01-Mar-26
|
373,242.58
|
65,006.42
|
438,249.00
|
438,249.00
|
7,838,094.20
|
||
01-Apr-26
|
373,242.58
|
62,051.58
|
435,294.16
|
435,294.16
|
7,464,851.62
|
||
01-May-26
|
373,242.58
|
59,096.74
|
432,339.32
|
432,339.32
|
7,091,609.04
|
||
01-Jun-26
|
373,242.58
|
56,141.90
|
429,384.49
|
429,384.49
|
6,718,366.46
|
||
01-Jul-26
|
373,242.58
|
53,187.07
|
426,429.65
|
426,429.65
|
6,345,123.88
|
||
01-Aug-26
|
373,242.58
|
50,232.23
|
423,474.81
|
423,474.81
|
5,971,881.29
|
||
01-Sep-26
|
373,242.58
|
47,277.39
|
420,519.97
|
420,519.97
|
5,598,638.71
|
||
01-Oct-26
|
373,242.58
|
44,322.56
|
417,565.14
|
417,565.14
|
5,225,396.13
|
||
01-Nov-26
|
373,242.58
|
41,367.72
|
414,610.30
|
414,610.30
|
4,852,153.55
|
||
01-Dec-26
|
373,242.58
|
38,412.88
|
411,655.46
|
411,655.46
|
4,478,910.97
|
||
01-Jan-27
|
373,242.58
|
35,458.05
|
408,700.63
|
408,700.63
|
4,105,668.39
|
||
01-Feb-27
|
373,242.58
|
32,503.21
|
405,745.79
|
405,745.79
|
3,732,425.81
|
||
01-Mar-27
|
373,242.58
|
29,548.37
|
402,790.95
|
402,790.95
|
3,359,183.23
|
||
01-Apr-27
|
373,242.58
|
26,593.53
|
399,836.11
|
399,836.11
|
2,985,940.65
|
||
01-May-27
|
373,242.58
|
23,638.70
|
396,881.28
|
396,881.28
|
2,612,698.07
|
||
01-Jun-27
|
373,242.58
|
20,683.86
|
393,926.44
|
393,926.44
|
2,239,455.49
|
||
01-Jul-27
|
373,242.58
|
17,729.02
|
390,971.60
|
390,971.60
|
1,866,212.90
|
||
01-Aug-27
|
373,242.58
|
14,774.19
|
388,016.77
|
388,016.77
|
1,492,970.32
|
||
01-Sep-27
|
373,242.58
|
11,819.35
|
385,061.93
|
385,061.93
|
1,119,727.74
|
||
01-Oct-27
|
373,242.58
|
8,864.51
|
382,107.09
|
382,107.09
|
746,485.16
|
||
01-Nov-27
|
373,242.58
|
5,909.67
|
379,152.26
|
379,152.26
|
373,242.58
|
||
01-Dec-27
|
(504,133.53)
|
793,128.00
|
373,242.58
|
2,954.84
|
376,197.42
|
665,191.89
|
(0.00)
|
(i) |
either (1) an “accredited investor” as defined in Rule 501(a)(1), (a)(2), (a)(3), (a)(7), (a)(8), (a)(9), (a)(12) or (a)(13) under the Securities Act; or (2) a “qualified institutional buyer” as defined in Rule 144A(a) under the Securities
Act.
|
(ii) |
located outside the State of Israel and (a) not a resident of the State of Israel, (b) has not engaged in or directed any unsolicited offers to purchase Securities in the State of Israel, (c) has purchased, or will be purchasing, as the
case may be, the Securities for its own account and not for the account or benefit of any resident of the State of Israel, and (d) has not pre-arranged any sale with a purchaser in the State of Israel.
|
BIOLINERX LTD.
|
|
Address for Notice:
|
|
|
|
Modi’in Technology Park
2 HaMa’ayan Street
Modi’in, 7177871, Israel
|
|
By:
|
|
|
Attention: Chief Executive Officer
|
Name: Philip Serlin
|
|
E-mail:
|
|
Title: Chief Executive Officer
|
|
|
|
With a copy to (which shall not constitute notice):
General Counsel
BioLineRx Ltd.
Email:
|
(A) | = | as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the ADSs on the principal Trading Market as reported by Bloomberg L.P. (“Bloomberg”) as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; |
(B) | = | the Exercise Price of this Warrant, as adjusted hereunder; and |
(X) | = | the number of Warrant ADSs that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. |
d) |
Mechanics of Exercise.
|
BIOLINERX LTD.
|
|
By:__________________________________________
Name:
Title:
|
Name:
|
______________________________________
|
(Please Print)
|
|
Address:
|
______________________________________
|
Phone Number:
Email Address:
|
(Please Print)
______________________________________
______________________________________
|
Dated: _______________ __, ______
|
|
Holder’s Signature:__________________________________
|
|
Holder’s Address: __________________________________
|
Number of ADSs: _______
|
Initial Exercise Date: November 21, 2024
Issue Date: November 21, 2024
|
(A) | = | as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the ADSs on the principal Trading Market as reported by Bloomberg L.P. (“Bloomberg”) as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day; |
(B) | = | the Exercise Price of this Warrant, as adjusted hereunder; and |
(X) | = | the number of Warrant ADSs that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise. |
d) |
Mechanics of Exercise.
|
BIOLINERX LTD.
|
|
By:__________________________________________
Name:
Title:
|
Name:
|
______________________________________
|
(Please Print)
|
|
Address:
|
______________________________________
|
Phone Number:
Email Address:
|
(Please Print)
______________________________________
______________________________________
|
Dated: _______________ __, ______
|
|
Holder’s Signature: ____________________________________
|
|
Holder’s Address: ____________________________________
|