Form 8-K - Current report
July 12 2024 - 3:00PM
Edgar (US Regulatory)
false
0001460602
0001460602
2024-07-12
2024-07-12
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 12, 2024
ORGENESIS
INC.
(Exact name of registrant as specified in its charter)
| Nevada
|
|
001-38416
|
|
98-0583166
|
| (State
or other jurisdiction |
|
(Commission
File |
|
(IRS
Employer |
| of
incorporation |
|
Number)
|
|
Identification
No.) |
20271
Goldenrod Lane, Germantown,
MD 20876
(Address of principal executive offices)
(Zip Code)
Registrant’s
telephone number, including area code: (480) 659-6404
Not
Applicable
(Former name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock |
|
ORGS
|
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b -2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
1.01 Entry into a Material Definitive Agreement.
On
July 12, 2024, Orgenesis Inc. (the “Company”) entered into an Asset Purchase Agreement (the “Purchase Agreement”)
with Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”)
for the purchase by the Company of the following assets (the “Assets”):
| |
● |
50%
of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently
owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and |
| |
● |
Certain
products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods,
standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current
Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating
a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing
process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform
which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment
of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal
stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery
and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and
interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials,
licenses, permits and approvals relating to Products as further described in the Purchase Agreement. |
Pursuant
to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price
of $13,000,000 (the “Consideration”), which is equal to the value of the Assets established by a third-party valuation firm
selected by the Company, less a debt adjustment in the amount of $10,324,241.79 which is owed by Theracell to the Company (the “Debt”).
The aggregate Consideration will be paid by the Company as follows: (i) $400,000 will be paid to Theracell within 60 days after signing
of the Purchase Agreement, (ii) $250,000 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii)
the remaining amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending
on December 30, 2028.
The
Purchase Agreement contains representations, warranties, and covenants of the parties that are customary for a transaction of this type.
The foregoing summary of the Purchase Agreement does not purport to be complete, and is subject to and qualified in its entirety by the
Purchase Agreement attached as Exhibit 10.1 to this Current Report on Form 8-K, which is incorporated herein by reference.
Item
2.01 Completion of Acquisition or Disposition of Assets
As
described in Item 1.01 of this Current Report on Form 8-K, on July [12], 2024, the Company acquired the Assets pursuant to the Purchase
Agreement. The information set forth under Item 1.01 is incorporated into this Item 2.01 by reference.
Item
9.01. Financial Statements and Exhibits.
The
exhibit listed in the following Exhibit Index is filed as part of this Current Report on Form 8-K.
*
Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally
a copy of any omitted attachment to the SEC upon request.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| Date:
July 12, 2024 |
By:
|
/s/
Victor Miller |
| |
|
Victor
Miller |
| |
|
Chief
Financial Officer, Treasurer and |
| |
|
Secretary
|
Exhibit
10.1
CONFIDENTIAL
ASSET
PURCHASE AGREEMENT
for
the
Theracell
Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and ΙDNA Genomics Public Limited (jointly and severally “Theracell”)
and
Orgenesis Inc and its subsidiaries. (“Orgenesis”)
July
12th, 2024
Theracell
and Orgenesis intending to be legally bound, hereby agree as follows:
| Purchaser |
Orgenesis,
Inc and / or any of its subsidiaries (“Orgenesis”) |
| |
|
| Seller |
Theracell
Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD, and ΙDNA GENOMICS PUBLIC LIMITED, jointly and severely (“Seller”). |
| |
|
Assets
|
Theracell
herby sells, assigns and transfers to Orgenesis and Orgenesis hereby purchases from Theracell
the following assets (collectively, “Assets”):
|
| |
|
| |
Asset
#1
|
| |
|
| |
50%
of ownership rights and shares in Theracell Laboratories IKE, so that immediately after such
sale, Orgenesis, shall own 100% of the outstanding shares of Theracell Laboratories IKE.
|
| |
|
| |
Asset
#2 |
| |
|
| |
The
Products described in Exhibit A to this Agreement (“Products”).
|
| |
|
Transfer
of Rights under JVA
|
In
addition Theracell Advanced Biotechnology LTD hereby transfers and assigns to Orgenesis, free of charge, all of Theracell Advanced Biotechnology
LTD’s rights under that certain ATP Joint Venture Agreement entered between Orgenesis and Theracell Advanced Biotechnology LTD,
dated December 25, 2022 (“ATP JVA”), including without limitation, all of Theracell Advanced Biotechnology LTD ‘s
shares in and/or rights in the JV Entity (as defined in the ATP JVA), and Theracell Advanced Biotechnology, S.A. hereby transfers and
assigned to Orgenesis, gratis, all of Theracell Advanced Biotechnology, S.A.’s rights under the Amended and Restated Joint Venture
Agreement dated August 21, 2020, between Orgenesis (or its affiliates) and Theracell Advanced Biotechnology, S.A., as revised by the
Separation Agreement dated December 22, 2022 (“Amended and Restated JVA”) including without limitation, all of Theracell
Advanced Biotechnology SA’s shares in and/or rights in the JV Entity as defined in the Amended and Restated JVA .
|
| Assignment |
Each
of Theracell, its affiliates, and Mr. Fotis Sakellaridis and Orgenesis shall sign all documents and assignment and take all other
actions reasonably requested by Orgenesis to effectuate the transfer and assignment of all rights, title and interest in and to the
Assets to Orgenesis. Without limiting the generality of the foregoing, upon the execution of this Agreement, Theracell, its affiliates,
and/or Mr. Fotis Sakellaridis (as applicable) shall execute and deliver to Orgenesis the Patent Assignment Agreement attached hereto
as Exhibit A. |
| |
|
| Consideration |
The
Parties to this Agreement have commissioned BDO Israel to perform an independent valuation of the Assets being sold pursuant to this
agreement. Such valuation, attached hereto as Exhibit E has determined a valuation of US$13,000,000 (Thirteen Million US Dollars).
Orgenesis will pay Theracell as consideration for the Assets (“Consideration”) the amount of $13,000,000 (Thirteen
Million US Dollars) less any amount due to Orgenesis and/or any of its subsidiaries (the “Debt”). The Consideration
will be paid by Orgenesis to Theracell as follows: |
| |
|
| |
|
● |
The
amount of $400,000 (Four Hundred Thousand US Dollars) will be paid to Theracell within 60
(sixty) days after the execution of this Agreement.
|
| |
|
|
|
| |
|
● |
The
amount of $250,000 (Two Hundred and Fifty Thousand) will be paid to Theracell within one
(1) year after the execution of this agreement.
|
| |
|
|
|
| |
|
● |
The
remaining amount of the Consideration (less any Debt) will be paid in four (4) equal annual payments on 12.30.2025, 12.30.2026, 12.30.2027
and 12.30.2027. |
| |
|
| |
On
any late payment an additional default interest will apply calculated at 10% annually on an actual/365-day conversion. |
Waiver
and Release/
Representations
and Warranties/
Indemnification
Clause |
Subject
to the consummation of the sale, assignment, and transfer of the Assets by Theracell to Orgenesis
and fulfillment of all other undertakings as set forth herein, including without limitation
Theracell’s indemnification undertaking below, each of Orgenesis and Theracell on behalf
of itself, its officers, subsidiaries, affiliated companies, successors and assigns hereby
remises, releases and forever discharges and covenants not to sue the other party, its successors,
assigns, affiliated companies and all employees, directors, officers and agents thereof,
from any liability of any kind, under any law or in tort and under any applicable jurisdiction,
whether direct or indirect, foreseen or unforeseen, contingent or actual, present or future,
and any claim, cause of action or demand made or to be made by the other party or by any
other person on behalf of the other Party, in respect of or arising out of the Assets, MSAs/SOWs,
JVAs and/or any other agreement signed between the parties, and any other actions, discussions
or negotiations prior to the execution of this Agreement. Notwithstanding the above, Theracell
hereby warrants that entering into this Agreement will not result in the imposition of any
charge, pledge, attachment, lien, liability, or other burden upon Orgenesis in respect of
the Assets transferred and will not give any third parties a cause, right, basis, or claim
against Orgenesis and/or its affiliates in respect of the Assets transferred. Without derogating
from the foregoing, it is hereby agreed that Orgenesis does not assume any liabilities of
Theracell, and that Theracell shall be solely responsible for any charges and liabilities
with respect to the Assets and relating to the period prior to the execution of this Agreement,
including, without limitation those set forth in listed in Exhibits C and D.
Theracell
shall indemnify, defend, and hold Orgenesis, its Affiliates and its employees, officers, directors, and agents harmless from and
against any and all actions, judgments, settlements, liabilities, damages, penalties, fines, losses, costs, and expenses (including
reasonable attorneys’ fees and expenses) to the extent arising out of any third party claim, demand, action and other proceeding
(each a “Claim”) related to the Assets transferred. |
| |
|
Confidentiality;
Publicity
|
Each
party hereto acknowledges and confirms that this Agreement and all terms hereof are confidential and, subject to applicable law,
that neither its existence nor the terms hereof will be disclosed to any other person other than parties’ officers, directors,
employees and advisors or potential investors under NDA, unless and to the extent required for fulfillment of any compliance, public
company disclosures, legal and/or regulatory obligations. |
| |
|
| Disclosure
Exhibits |
Exhibit
C and Exhibit D for disclosure purposes are attached hereto. |
| |
|
| Governing
Law |
This
Agreement shall be governed by the laws of the State of New York, United States of America, without regard to its conflict of law
provisions. |
Binding Agreement; Further
Assurances
|
Each
Party represents and warrants to the other Party that this Agreement is a legal and valid obligation binding upon such Party and
is enforceable in accordance with its terms. This Agreement supersedes any prior agreements between the parties with respect to the
subject matter hereof. The execution, delivery, and performance of this Agreement by such party does not conflict with any agreement,
instrument or understanding, oral or written, to which such Party is a party or by which such party may be bound, nor violate any
law or regulation of any court, governmental body or administrative or other agency having authority over such party. From time to
time, at Orgenesis’ request and without further consideration, Theracell shall execute and deliver such additional documents
and take all such further action as may be reasonably necessary or reasonably requested to effect the actions and consummate the
transactions contemplated by this Agreement. |
| |
|
| |
IN
WITNESS WHEREOF, the parties have executed this Agreement as of the dates set forth below. |
| |
|
|
| Theracell
Advanced Biotechnology, S.A |
|
Orgenesis
Inc. |
| |
|
|
| by: |
|
|
by: |
|
| name: |
|
|
name: |
|
| title: |
|
|
title: |
|
| |
|
|
|
|
| Theracell
Advanced Biotechnology LTD |
|
|
|
| |
|
|
|
by:
|
|
|
|
|
name:
|
|
|
|
|
| title: |
|
|
|
|
| |
|
|
|
|
| IDNA
GENOMICS PUBLIC LIMITED |
|
|
|
| |
|
|
|
by:
|
|
|
|
|
name:
|
|
|
|
|
title:
|
|
|
|
|
Agreed
and accepted by Mr. Fotis Sakellaridis:______________
v3.24.2
| X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
| Name: |
dei_AmendmentFlag |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
| Name: |
dei_DocumentPeriodEndDate |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:dateItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
| Name: |
dei_DocumentType |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:submissionTypeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
| Name: |
dei_EntityAddressAddressLine1 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Definition
+ References
+ Details
| Name: |
dei_EntityAddressCityOrTown |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCode for the postal or zip code
| Name: |
dei_EntityAddressPostalZipCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the state or province.
| Name: |
dei_EntityAddressStateOrProvince |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:stateOrProvinceItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityCentralIndexKey |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:centralIndexKeyItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionIndicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityEmergingGrowthCompany |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
Innovator Ibd Breakout O... (AMEX:BOUT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Innovator Ibd Breakout O... (AMEX:BOUT)
Historical Stock Chart
From Jul 2023 to Jul 2024
