FIRST ADDENDUM TO LICENSE AGREEMENT
Exhibit 4.51
FIRST ADDENDUM TO LICENSE AGREEMENT
This First Addendum (the “First Addendum”) to that certain License Agreement entered into by and between Biokine
Therapeutics Ltd. (“Biokine”) and BioLineRx Ltd. (“BioLine”) dated September 2, 2012, as subsequently amended (the “Agreement”), is made effective as of October 16, 2019 (the “Addendum Effective Date”). Capitalized terms not defined in this First Addendum shall have the meanings given
to them in the Agreement.
Whereas, the Parties desire to set out certain commercial and ownership arrangements with respect to (i) that certain US Provisional
Patent Application number 62746587 (titled “Treatment of Metastatic Pancreatic Adenocarcinoma”), a copy of which is attached hereto at Annex A (hereinafter, the “New
Patent Application”); and (ii) certain other developments to the Licensed Technology that the Parties have arrived at in the past and may in the future may arrive at.
Now, therefore, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties agree as follows:
(a) Biokine acknowledges that, as between Biokine and BioLine, BioLine is the exclusive owner of all intellectual property rights in, to and under the New Patent
Application, as well as any patent issuing thereon, and any foreign counterpart, international counterpart, divisional, continuation, continuation-in-part, reissue, renewal, reexamination, substitution or extension thereof or thereto
(collectively, the “New Patent Application Rights”).
(b) Without derogating from the legal ownership interest expressed in Section 1(a) above, the Parties agree that, subject to the additional provisions of this
Section 1, from commercial, economic and definitional perspectives only: (A) BioLine’s interest in the New Patent Application Rights shall be deemed to be included as part of the definition of “Licensed Technology” in the Agreement (it being
clarified, for the avoidance of doubt, that there is technically no actual license being granted by Biokine with respect to the New Patent Application Rights as contemplated in Section 2.2 of the Agreement); and (B) any product, in any
indication, that comprises, contains, incorporates or is covered by New Patent Application Rights shall be deemed to be included as part of the definition of “Licensed Product” in the Agreement.
As examples only, of the foregoing: (i) Biokine shall be entitled to receive payments on Sublicense Receipts, pursuant to Section 6.3 (Payments on Sublicense
Receipts) of the Agreement, in connection with New Patent Application Rights; and (ii) Biokine shall be entitled to receive royalties, pursuant to Section 6.7 (Royalty Payments) of the Agreement,
in connection with New Patent Application Rights.
(c) The arrangement in Section 1(b) above, however, shall not apply in the following circumstances:
(i) |
For the purpose of Section 12.2 of the Agreement (Effect of Expiration), following the expiration of this Agreement pursuant to Section 12.1, BioLine shall retain the right to exploit the
New Patent Application Rights; provided, however, that Biokine shall have a non-exclusive, non-royalty-bearing, fully paid-up, worldwide license under BioLine’s rights in, to and under the New
Patent Application Rights to research, have researched, develop, have developed, manufacture, have manufactured, use, market, distribute, offer for sale, sell, have sold, export and import Licensed Products and/or provide services
relating thereto.
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(ii) |
Solely for the purpose of Section 12.4 of the Agreement (Effect of Termination) (and not for Section 3.2 of the Agreement), (x) the New Patent Application Rights shall be treated as a New
Development and the arrangements set out in Section 12.4.2 of the Agreement shall apply with respect thereto; provided, however, that the license granted to Biokine pursuant to Section 12.4.2
shall be non-royalty-bearing; and (y) upon termination of the Agreement, BioLine’s rights and licenses in and to the Licensed Technology shall terminate in accordance with Section 12.4.1, and BioLine shall cease all access and use of
the Licensed Technology and comply with the destruction and return obligations stated therein.
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2. |
(a) Prior Developments. In respect of the developments listed in Annex B attached hereto that arose prior to the Addendum Effective Date and in connection of which the Parties have in the past (including without limitation by course of conduct) agreed to joint ownership of the intellectual property rights
therein and thereto (the “Prior Developments”), the Parties hereby agree that each Party shall own an undivided one-half interest in, to and under such Prior Developments, and Biokine’s interest therein and
thereto shall be and is hereby confirmed to be included within the scope of Licensed Technology under the Agreement.
(b) Future Developments. The Parties hereby agree that with respect to developments that arise after the Addendum Effective Date (“Future Developments”) that are invented or created jointly by Biokine or by persons having an obligation to assign such rights to Biokine, and by BioLine or by persons having an obligation to assign such rights to BioLine, each
Party shall own an undivided one-half interest in, to and under any such Future Developments, and Biokine’s interest therein and thereto shall be and is hereby confirmed to be included within the scope of Licensed Technology under the Agreement.
BioLine agrees to keep Biokine informed via the Joint Development Committee (including by providing relevant details any further information reasonably requested by Biokine) of any ownership
rights asserted or claimed (or anticipated to be asserted or claimed) by any third party (including, but not limited to, by Merck Sharp & Dohme B.V. (“Merck”) or its Affiliates pursuant to that certain
Clinical Trial Collaboration and Supply Agreement (for Pancreatic Cancer Study) between Merck and BioLine, dated January 11, 2016 – hereinafter, the “BioLine-Merck
Agreement”) in or to any Prior Developments and/or Future Developments.
4. |
The ownership arrangements described herein (a) may only be amended or supplemented by written agreement signed by both Parties; and (b) shall apply notwithstanding anything, in the past or
future, stated, testified or indicated to the contrary before any patent offices or similar authorities, or in any filing or registration before such offices or authorities (such as within the New Patent Application itself). The Parties shall in
good faith cooperate, and execute such documents and perform such acts (including without limitation executing and giving all necessary filing, registrations, recordations, oaths, declarations, affidavits, waivers, and assignments to or before
applicable patent offices and authorities worldwide), to give effect to the ownership arrangements described herein with respect to Prior Developments and Future Developments. Furthermore, in connection with securing, protecting, or enforcing any
of its ownership rights under this First Addendum, either Party may at any time seek equitable relief in any court of competent jurisdiction.
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Excluding any assignment or transfer to Merck, In the event BioLine assigns or otherwise transfers to a third party (a "Third Party Purchaser") all or part
of its ownership in, to or under New Patent Application Rights, such Third Party Purchaser shall be bound by the terms and conditions of this First Addendum (including without limitation the obligation to pay Sublicense Receipts and royalties in
connection therewith), and the consideration paid by or on behalf of said Third Party Purchaser under such assignment or transfer, shall be deemed a Sublicense Receipt under the Agreement.
This First Addendum shall be considered part of the Agreement and, in connection with intellectual property rights ownership in, to, and under the New Patent Application Rights, and/or Prior
Developments and Future Developments, this First Addendum shall prevail to the extent of any conflict with any provision of the main body of the Agreement. Except as expressly provided herein, the provisions of the Agreement shall remain
unchanged and apply mutatis mutandis to this First Addendum.
[Intentionally Left Blank; Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this First Addendum to be duly executed by their authorized representatives.
BIOKINE THERAPEUTICS LTD.
By: /s/ Xxxxx Xxxxx
Name: Xxxxx Xxxxx
Title: CEO
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By: /s/ Mali Zeevi
Name: Mali Zeevi
Title: CFO
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16/10/2109
/s/ X X Xxxx
Xx X X Xxxx
Chairman, Biokine
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ANNEX A
New Patent Application
Embedded files: Provisional Patent Application No. 62746587, filed
October 17, 2018
Electronic Acknowledgement Receipt for above application
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ANNEX B
Prior Developments
Parent Patent Application
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Title
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PCT/IL2018/051023
Filed on 12 September 2018
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METHODS OF TREATING DISEASES ASSOCIATED WITH VASCULAR SMOOTH MUSCLE CELL PROLIFERATION
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Provisional Patent Application 62/875,522
Filed on 18 July 2019
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COMBINATION THERAPY FOR TREATING CANCER
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PCT/IL2019/051057
Filed on 25 September 2019
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METHODS OF SELECTING TREATMENT FOR CXCR4-ASSOCIATED CANCER
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PCT/IL2019/051127
Filed on 17 October 2019
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COMBINATION THERAPY FOR TREATMENT OF PANCREATIC CANCER
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PCT/IL2019/051126
Filed on 17 October 2019
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COMBINATION THERAPY FOR TREATMENT OF PANCREATIC CANCER
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