| COLLABORATIONS, LICENSE AGREEMENTS AND COMMITMENTS | NOTE
6 – COLLABORATIONS, LICENSE AGREEMENTS AND COMMITMENTS Image
Securities Ltd. (a related party) As
described in Note 12 to the financial statements of December 31, 2019, on July 11, 2018, the Company and Image Securities Ltd.,
a corporation with its registered office in Grand Cayman, Grand Cayman Islands (“India Partner”), entered into a Joint
Venture Agreement (the “India JVA”) pursuant to which the parties will collaborate in the development, marketing,
clinical development and/or commercialization of cell therapy products in India (the “Cell Therapy Products”). The
India Partner will collaborate with a network of healthcare facilities and a healthcare infrastructure as well as financial partners
to advance the development and commercialization of the cell therapy products in India. As of September 30, 2020, the Company
had advanced $ 3 500 During January 2020, the
Company entered into a new statement of work pursuant to the master services agreement signed in 2019 for the provision of certain
services during 2020 and 2021 in India. The Company, subject to mutually agreed timing and definition of the scope of services,
will provide regulatory services, pre-clinical studies, intellectual property services, point-of-care services and co-development
services to the India Partner. $ 1,051
Apart
from the above, there was no activity in the India joint venture during the nine months ended September 30, 2020 (See Note
10). Hemogenyx
Pharmaceuticals PLC. As
described in Note 12 to the financial statements of December 31, 2019, on October 18, 2018, the Company and Hemogenyx Pharmaceuticals
PLC., a corporation with its registered office in the United Kingdom, and Hemogenyx-Cell, a corporation with its registered office
in Belgium, and which is engaged in the development of cell replacement bone marrow therapy technology (“H-Cell” and,
collectively with the Company, “Hemo”), entered into a Collaboration Agreement (the “Hemo Agreement”)
pursuant to which the parties will collaborate in the funding of the continued development of and commercialization of, the Hemo
technology via the Hemo group companies. Pursuant to the Hemo Agreement, the Company and Hemogenyx LLC, a wholly owned U.S. subsidiary
of Hemo (“Hemo-LLC”), entered into a loan agreement. During the nine months ended September 30, 2020, the Company
advanced $ 250 Immugenyx
LLC As
described in Note 12 to the financial statements as of December 31, 2019, on October 16, 2018, the Company and Immugenyx LLC,
(“Immu”), which is engaged in the development of technology related to the production and use of humanized mice, entered
into a Collaboration Agreement (the “Immu Agreement”) pursuant to which the parties will collaborate in the funding
of the continued development of, and commercialization of, the Immu technology. The Company received the worldwide rights to market
the products under the Immu Agreement in consideration for the payment of a 12 250 Theracell
Advanced Biotechnology As
described in Note 12 to the financial statements as of December 31, 2019, on February 14, 2019, the Company and Theracell Advanced
Biotechnology, a corporation organized under the laws of Greece (“Theracell”), entered into a Joint Venture Agreement
(the “Greek JVA”). During the third quarter of 2020, the Company and Theracell entered into an amended and restated
joint venture agreement that supersedes the Greek JVA (the “new Greek JVA”). Pursuant to the new Greek JVA, the parties
will collaborate in the clinical development and commercialization of the Company’s products (hereinafter, the “Company
Products”) in Greece, Turkey, Cyprus, the Balkan countries and Israel (the “Territory”) and the clinical development
and commercialization of Theracell’s products (hereinafter, the “Theracell Products”) worldwide (the “Theracell
Project”). Under the new Greek JVA, Theracell will be responsible to obtain required marketing approvals for the Theracell
Products and the Company Products in the Territory based on Clinical Trials (as defined in the Greek JVA) and regulatory requirements,
and be responsible for procuring and funding the clinic elements of the Clinical Trials and regulatory approvals for the Theracell
Products and the Company Products in the Territory. The Company will be responsible to fund the production costs of the Theracell
Products and the Company Products required for the Clinical Trials within the Territory and either supply the Theracell Products
and/or the Company Products for the Clinical Trials or cover the relevant production/processing costs. In
addition, each of the parties will be responsible to provide the Greek JV Entity (as defined below) with funding in an amount
of at least five million US Dollars ($ 5,000 The
Company may choose to provide the funding required as part of its obligations under the new Greek JVA as well as the Additional
Investment by engaging Theracell or the Greek JV Entity to perform activities, and research and development services to create,
optimize, improve the Orgenesis Background IP, technology, processes, system, and validation, (“ORGS Procured Services”)
in an amount of up to fifteen million US Dollars ($ 15,000 1,500 Theracell
also agreed to grant to the Greek JV Entity, during the term, an exclusive, sublicensable right and license to the Theracell Background
IP as required solely to manufacture, distribute and market and sell Theracell Products within the Territory, subject and in accordance
with the terms of a separate license agreement to be signed between Theracell and the Greek JV Entity (“Theracell License
Agreement”). In consideration of the rights and the Theracell licenses to be granted to the Greek JV Entity during the Term
under the Theracell License Agreement, Theracell shall receive royalty in an amount of up to ten percent ( 10 10 The
Company agreed to grant to the Greek JV Entity, during the term, an exclusive, sublicensable, royalty bearing, right and license
to the Orgenesis Background IP as required solely to manufacture, distribute and market and sell the Company Products within the
Territory, subject and in accordance with the terms of a separate license agreement to be signed between the Company and the Greek
JV Entity (“Orgenesis License Agreement”). In consideration of the rights and the Orgenesis license to be granted
to the Greek JV Entity during the Term under the Orgenesis License Agreement, the Company shall receive royalty in an amount of
ten percent ( 10 Once
the Greek JV Entity is profitable, the Company shall be entitled to an additional share of fifteen percent ( 15 The
parties intend to pursue the Theracell Project through a joint venture (“JV”) by forming a JV entity (the “Greek
JV Entity”). Until the Greek JV Entity is formed, all JV activities are being carried out by Theracell. The Company by itself,
or together with a designee, will hold a 50 50 During
January 2020, the Company entered into a new statement of work pursuant to the master services agreement signed in 2019 with Theracell
for the provision of certain services by the Company during 2020 and 2021. During the nine months ended September 30, 2020, the
Company recognized point of care service revenue in the amount of $ 1,068 During
the nine months ended September 30, 2020, the Company recorded expenses related to activities in the Territory in the amount of
$ 896
thousand (See Note 10). Broaden
Bioscience and Technology Corp As
described in Note 12 to the financial statements as of December 31, 2019, on November 10, 2019, the U.S. Subsidiary and Broaden
Bioscience and Technology Corp, a Delaware corporation (“Broaden”), entered into a Joint Venture Agreement (the “Broaden
JVA”) pursuant to which the parties will collaborate in the development and/or marketing, clinical development and commercialization
of cell therapy products and the setting up of point-of-care processing facilities in China and the Middle East (the “Broaden
Project”). The parties intend to pursue the Broaden Project through a joint venture by forming a joint venture entity (the
“Broaden JV Entity”). During
January 2020, the Company entered into a master service agreement with Broaden whereby the Company, subject to mutually agreed
timing and definition of the scope of services, will provide regulatory services, pre-clinical studies, intellectual property
services, GMP process translation services and co-development services to Broaden during 2020 and 2021. During the nine months
ended September 30, 2020, the Company recognized point of care services revenue in the amount of $ 1,143 During
January 2020, the U.S. Subsidiary and Broaden entered into a convertible loan agreement pursuant to which the Company agreed to
lend Broaden an amount of up to $ 5 During
the nine months ended September 30, 2020, the Company recorded research and development expenses related to activities in the
Broaden JVA in the amount of $ 830 Apart
from the above, as of September 30, 2020, the Broaden JV Entity had not been incorporated (See Note 10). Cure
Therapeutics During
2019, the Company entered into a master service agreement with Cure Therapeutics (“CT”) whereby the Company, subject
to mutually agreed timing and definition of the scope of services, will provide point-of-care services to CT during 2020 and 2021.
During the nine months ended September 30, 2020, the Company recognized point of care services revenue in the amount of $ 1,029 As
described in Note 12 to the financial statements as of December 31, 2019, on May 7, 2018, the Company and CT entered into a collaboration
agreement for the development of therapies based on liver and NK cells. An amount of $ 1,827 . 1,035 In
addition, during the third quarter of 2020, the Company and CT entered into a joint venture agreement (“CT JVA”),
pursuant to which the parties will collaborate in point of care (“POC”), processing, regulatory and governmental affairs
and therapy development and commercialization of Company’s and CT’s products (excluding HEPA and NK cells products)
within the territories of South Korea and Japan (the “CT Territory”). The
parties intend to pursue the CT JVA through a joint venture by forming a JV entity (the “CT JV Entity”). Until the
CT JV Entity is formed, all JV activities are being carried out by CT. The Company by itself, or together with a designee, will
hold a 50 50 As
of September 30, 2020, the CT JV entity had not yet been incorporated. Under
the CT JVA, CT will be responsible to obtain required marketing approvals for the CT and Company Products in the CT Territory
based on clinical trials and regulatory requirements. In
addition, each of the Parties will be responsible to provide the CT JV with funding in an amount of at least ten million US Dollars
($ 10,000 The
Company may choose to provide the funding required as part of its obligations under the CT JVA by engaging CT or the CT JV to
perform services, and research and development services to create, optimize, improve the Orgenesis Background IP, technology,
processes, system, and validation, (“CT-ORGS Procured Services”). The CT-ORGS Procured Services will be subject to,
and will be carried out by CT or the CT JV (as applicable) in accordance with a separate Master Services Agreement (the “CT
MSA”). All results of the ORGS Procured Services shall be owned by Company. The Company and CT executed such CT MSA in the
third quarter of 2020, pursuant to which CT agreed to provide the Company with services in the amount of $ 4.5
million according to an approved work
program. The Company did not recognize any such procured services in the third quarter of 2020 (See Note 10). CT
also agreed to grant to the CT JV, during the term, an exclusive, sublicensable right and license to the CT Background IP (as
defined in the CT MSA) as required solely to manufacture, distribute and market and sell CT Products (as defined in the CT MSA)
within the CT Territory, subject and in accordance with the terms of a separate license agreement to be signed between CT and
the CT JV (“CT License Agreement”). In consideration of the rights and the CT licenses to be granted to the CT JV
during the Term under the CT License Agreement, CT shall receive royalty in an amount of up to ten percent ( 10 10 The
Company agreed to grant to the CT JV, during the term, an exclusive, sublicensable, royalty bearing, right and license to the
Orgenesis Background IP as required solely to manufacture, distribute and market and sell Orgenesis Products within the CT Territory,
subject and in accordance with the terms of a separate license agreement to be signed between Orgenesis and the CT JV (“CT-Orgenesis
License Agreement”). In consideration of the rights and the Orgenesis license to be granted to the CT JV during the Term
under the CT-Orgenesis License Agreement, Orgenesis shall receive royalty in an amount of ten percent ( 10 Once
the CT JV is profitable, the Company shall be entitled to an additional share of fifteen percent (15 %)
of the CT JV’s Audited GAAP profit after tax, over and
above all rights granted pursuant to the Company’s participating interest in the CT JV. Mircod
Limited As
described in Note 12 to the financial statements as of December 31, 2019, on June 19, 2018, the Company and Mircod Limited, a
company formed under the laws of Cyprus (“Mircod”), entered into a Collaboration and License Agreement (the “Mircod
Collaboration Agreement”) for the adaptation of Mircod’s background technologies related to biological sensing for
use of the Company’s clinical development and manufacturing projects (the “Development Project”). The Development
Project is to be carried out in accordance with an agreed development plan. During the nine months ended September 30, 2020, the
Company recorded research and development expenses related to the development plan in the amount of $ 800 In
addition, during the first quarter of 2020, as per the Mircod Collaboration agreement, Mircod formed a wholly-owned US subsidiary
named Mircod Biotech (the “Mircod Subsidiary”). The Mircod Subsidiary shall perform the duties of Mircod under the
Collaboration Agreement, provided that Mircod shall remain responsible for the performance of the Mircod Subsidiary. At any time,
the Company shall have the option, at its sole discretion, to transfer and require Mircod or the Mircod Subsidiary to transfer
the Development Project and/or the rights and licenses granted by Mircod to a joint venture company (“Mircod JV Entity”)
which shall be established by the parties for the purposes of carrying out and commercializing the Development Project, and in
which the Company and Mircod will each hold 50 HekaBio
K.K As
described in Note 12 to the financial statements as of December 31, 2019, on July 10, 2018, the Company and HekaBio K.K. (“HB”),
a corporation organized under the laws of Japan entered into a joint venture agreement (the “HB JVA”) pursuant to
which the parties will collaborate in the clinical development and commercialization of regeneration and cell and gene therapeutic
products in Japan, and on October 3, 2018, the Company entered into a license agreement with the joint venture company pursuant
to the HB JVA. During
the third quarter of 2020, the Company and HV agreed to terminate such license agreement. Apart
from the above, as of September 30, 2020, no material activity had begun in the HB JVA. Kidney
Cure Ltd During
April 2020, the Company entered into a joint venture agreement with Kidney Cure Ltd. (“Kidney Cure” and the “Kidney
Cure JVA,” respectively), pursuant to which the parties will collaborate in the (i) implementation of a point-of-care strategy;
(ii) assessment of the options for development and manufacture of various cell-based types (including kidney derived cells, MSC
cells, exosomes, gene therapies) development; and (iii) development of protocols and tests for kidney therapies (the “Project”).
The parties intend to pursue the joint venture through a newly established company (hereinafter, the “KC JV Entity”),
which the Company, directly or indirectly by itself, will hold a 49 51 The
Company will procure services from the Kidney Cure JVA in the amount of $5 million, subject to and in accordance with a development
and manufacturing plan to be mutually agreed upon by the parties. Under the Kidney Cure JVA, the Company can require Kidney Cure
to sell to the Company its participating (including equity) interest in the KC JV Entity in consideration for the issuance of
Common Stock based on an agreed-upon formula for determining the KC JV Entity’s valuation, provided that Company has contributed
at least $ 5 450 Apart
from the above, as of September 30, 2020, no activity has begun in the said KC JV Entity, no contributions were made therein and
the KC JV Entity had not been incorporated (See Note 10). Sescom
Ltd During
April 2020, the Company entered into a joint venture agreement with Sescom Ltd (“Sescom”), pursuant to which the parties
will collaborate in (i) the assessment of relevant tools and technologies to be used in the Company’s information security
system (the “ISS”); (ii) the implementation of the ISS within the Company and in the Company’s point-of-care
network; and (iii) the operation and maintenance of the ISS. The parties intend to pursue the joint venture through a company
to be established (the “Sescom JV Entity”), which shall be 50 50 Sescom
has agreed to provide Sescom JV Entity with: (a) a non-exclusive, transferable and sublicensable worldwide royalty-free license
to use its background IP, to the extent required for carrying out the development activities by the Sescom JV Entity; and (b)
to make available to the Sescom JV Entity all relevant know-how and royalty-free licenses to any proprietary technologies to be
implemented as part of the ISS. The
Company has agreed to procure services from Sescom or the Sescom JV Entity in an amount of up to $ 1 500 The
parties agreed that at any time after the Company has contributed $ 1 Apart
from the above, as of September 30, 2020, no other activity had taken place in the Sescom JV Entity and the Sescom JV Entity had
not been incorporated. Tamir
Biotechnology, Inc. On
April 7, 2020, the Company entered into the Tamir Purchase Agreement with Tamir, pursuant to which the Company agreed to acquire
certain assets and liabilities of Tamir related to the discovery, development and testing of therapeutic products for the treatment
of diseases and conditions in humans, including all rights to Ranpirnase and use for antiviral therapy. The Tamir Transaction
closed on April 23, 2020. As
aggregate consideration for the acquisition, the Company paid $ 2.5 3,400,000 20.2 59 340,000 4.5 Included
in the purchased assets was the assumption by the Company of a worldwide license to a private company of certain Tamir technologies
in the field of treatment, amelioration, mitigation or prevention of diseases or conditions of the eye and its adnexa in return
for certain development and sales milestone payments to be paid to Tamir. This license fee and the right to receive future milestone
payments (of up to $ 11 35 10 The
Company’s acquired right to Tamir’s intellectual property represents a single identifiable asset sourced from the
agreement. Because substantially all (more than 90 19.5 Extracellular
Vesicle (“EV”) Technology License During
the third quarter of 2020, the Company purchased the IP and related EV technology from a service provider (the “Service
Provider”) pursuant to an EV agreement (the “EV agreement”). According to the EV agreement, the Service Provider
sold to the Company all of its rights in the EV technology that it had produced, in the amount of $500 thousand, to be paid in
equal installments over the next 12 months from September 2020. During September 2020, the Company paid $ 50 500 |
