Exhibit
10.2
STOCKHOLDERS
AGREEMENT
THIS
STOCKHOLDERS AGREEMENT (this “Agreement”), is made and entered into as of this 18th day of March,
2021, by and among Oravax Medical Inc., a Delaware corporation (the “Company”) and those certain stockholders
of the Company listed on Schedule A (together with any subsequent stockholders or holders of options to acquire shares of
the capital stock of the Company, or any transferees, who become parties hereto as “Stockholders” pursuant to Subsections
8.1 or 8.2 below, the “Stockholders”).
RECITALS
The
parties desire to enter into this Agreement to set forth their agreements and understandings with respect to how shares of the
Capital Stock of the Company held by them will be voted in connection with an acquisition of the Company or the election of directors
to the board of directors of the Company (the “Board”) and certain other matters contemplated hereby.
AGREEMENT
NOW,
THEREFORE, the Company and the Stockholders each hereby agree as follows:
1. Definitions.
As used herein, the following terms shall have the following meanings:
1.1 “Affiliate”
means, with respect to any Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common
control with such Person, including, without limitation, any general partner, officer, director, or managing member of such Person
and any venture capital fund now or hereafter existing which is controlled by or under common control with one or more general
partners or shares the same management company with such Person.
1.2 “Akers”
means Akers Biosciences, Inc.
1.3 “Capital
Stock” means (a) shares of common stock of the Company, par value $0.001 per share (“Common Stock”)
(whether now outstanding or hereafter issued in any context), (b) shares of preferred stock of the Company (whether now outstanding
or hereafter issued in any context) and (c) and all other securities of the Company which may be exchangeable for, convertible
into or issued in exchange for or in respect of shares of Common Stock (whether by way of stock split, stock dividends, combination,
reclassification, reorganization or any other means).
1.4 “Charter”
means that certain Certificate of Incorporation, filed with the Secretary of State of Delaware on March 10, 2021, as amended from
time to time.
1.5 “Company
Notice” means written notice from the Company notifying the Stockholders that the Company intends to exercise its Right
of First Refusal as to some or all of the Transfer Stock with respect to any Proposed Stockholder Transfer.
1.6 “Contribution
Agreement” means that certain Contribution and Assignment Agreement, dated as of the date hereof, by and among the Company,
Akers and Cystron Biotech LLC (“Cystron”).
1.7
“Deemed Liquidation Event” means each of the following events, unless the Requisite Stockholders elect otherwise
by written consent sent to the Company at least 10 days prior to the effective date of any such event: (a) a merger or consolidation
in which (i) the Company is a constituent party, or (ii) a subsidiary of the Company is a constituent party and the Company issues
shares of its Capital Stock pursuant to such merger, or consolidation, except, any such merger or consolidation involving the Company
or a subsidiary in which the shares of Capital Stock outstanding immediately prior to such merger or consolidation continue to
represent, or are converted into or exchanged for shares of Capital Stock that represent, immediately following such merger or
consolidation, at least a majority, by voting power, of the Capital Stock of (1) the surviving or resulting corporation; or (2)
if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger
or consolidation, the parent corporation of such surviving or resulting corporation, or (b) (i) the sale, lease, transfer, exclusive
license or other disposition, in a single transaction or series of related transactions, by the Company or any subsidiary of the
Company of all or substantially all the assets of the Company and its subsidiaries taken as a whole, or (ii) the sale or disposition
(whether by merger, consolidation or otherwise, and whether in a single transaction or a series of related transactions) of one
or more subsidiaries of the Company if substantially all of the assets of the Company and its subsidiaries taken as a whole are
held by such subsidiary or subsidiaries, except, in each case, where such sale, lease, transfer, exclusive license or other disposition
is to a wholly owned subsidiary of the Company.
1.8 “Derivative
Securities” means any securities or rights convertible into, or exercisable or exchangeable for (in each case, directly
or indirectly), Common Stock, including options and warrants.
1.9 “Going
Public Event” means (i) the IPO or (ii) any other listing of the Company’s shares on a national securities exchange
(including, without limitation, a Spin Off).
1.10 “IPO”
means the Company’s first underwritten public offering of its Common Stock under the Securities Act.
1.11 “New
Securities” means, collectively, equity securities of the Company, whether or not currently authorized, as well as rights,
options, or warrants to purchase such equity securities, or securities of any type whatsoever that are, or may become, convertible
or exchangeable into or exercisable for such equity securities.
1.12 “Oramed”
means Oramed Pharmaceuticals, Inc. or one of its Affiliates.
1.13 “Oramed
License Agreement” means that certain license agreement, dated as of the date hereof, by and among the Company, Oramed
Pharmaceuticals, Inc. and one of its Affiliates for the development of an oral delivery system for that certain vaccine candidate
described in the License Agreement (as such term is defined in the Contribution Agreement).
1.14 “Person”
means any individual, corporation, partnership, trust, limited liability company, association or other entity.
1.15 “Premas
Parties” means Premas Biotech PVT Ltd., Cutter Mill Capital LLC and Run Ridge LLC.
1.16 “Proposed
Stockholder Transfer” means any assignment, sale, offer to sell, pledge, mortgage, hypothecation, encumbrance, disposition
of or any other like transfer or encumbering of any Transfer Stock (or any interest therein) proposed by any of the Stockholder;
provided, that a Proposed Stockholder Transfer shall not include any merger, consolidation or like transfer effected pursuant
to a vote of the holders of Capital Stock of the Company.
1.17 “Proposed
Transfer Notice” means written notice from a Stockholder setting forth the terms and conditions of a Proposed Stockholder
Transfer.
1.18 “Prospective
Transferee” means any person to whom a Stockholder proposes to make a Proposed Stockholder Transfer.
1.19 “Qualified
Financing” has the meaning set forth in the Contribution Agreement.
1.20 “Requisite
Stockholders” means the Stockholders holding at least a majority of the voting power of Common Stock, voting as a single
class on an as-converted basis.
1.21 “Right
of Co-Sale” means the right, but not an obligation, of a Stockholder to participate in a Proposed Stockholder Transfer
on the terms and conditions specified in the Proposed Transfer Notice.
1.22 “Right
of First Refusal” means the right, but not an obligation, of the Company, or its permitted transferees or assigns, to
purchase some or all of the Transfer Stock with respect to a Proposed Stockholder Transfer on the terms and conditions specified
in the Proposed Transfer Notice.
1.23 “Shares”
means Capital Stock that is outstanding.
1.24 “Secondary
Notice” means written notice from the Company notifying the Stockholders that the Company does not intend to exercise
its Right of First Refusal as to all shares of any Transfer Stock with respect to a Proposed Stockholder Transfer on the terms
and conditions specified in the Proposed Transfer Notice.
1.25 “Secondary
Refusal Right” means the right, but not an obligation, of each Stockholder to purchase up to its pro rata portion (based
upon the total number of shares of Capital Stock then held by all Stockholders) of any Transfer Stock not purchased pursuant to
the Right of First Refusal, on the terms and conditions specified in the Proposed Transfer Notice.
1.26 “Spin
Off” means the distribution of all or a portion of the shares of Common Stock owned by Akers to Akers’ stockholders
on a pro rata basis and which results in the listing of the Common Stock on a national securities exchange.
1.27 “Transfer
Stock” means shares of Capital Stock owned by a Stockholder or issued to a Stockholder after the date hereof (including,
without limitation, in connection with any stock split, stock dividend, recapitalization, reorganization, or the like).
1.28 “Undersubscription
Notice” means written notice from a Stockholder notifying the Company and the other Stockholders that such Stockholder
intends to exercise its option to purchase all or any portion of the Transfer Stock not purchased pursuant to the Right of First
Refusal or the Secondary Refusal Right.
1.29 “Sale
of the Company” means either: (a) a transaction or series of related transactions in which a Person, or a group of related
Persons, acquires shares of the Company from a Person other than the Company and, after such transaction or series of related transactions,
holds more than fifty percent (50%) of the outstanding voting power of the Company; or (b) a transaction that qualifies or would
qualify as a Deemed Liquidation Event.
1.30 “Stockholder
Notice” means written notice from any Stockholder notifying the Company and the selling Stockholder(s) that such Stockholder
intends to exercise its Secondary Refusal Right as to a portion of the Transfer Stock with respect to any Proposed Stockholder
Transfer.
2. Voting
Provisions Regarding the Board and Other Matters.
2.1 Size
of the Board. Each Stockholder agrees to vote, or cause to be voted, all Shares now owned or hereafter acquired by such Stockholder,
or over which such Stockholder has voting control, from time to time and at all times, in whatever manner as shall be necessary
to ensure that the size of the Board shall be set and remain at three (3) directors. Each Stockholder agrees to attend, in person
or by proxy, all meetings of stockholders called for the purpose of this Subsection 2.1 and to take all actions, including,
but not limited to, the nomination of specified persons, the execution of written consents and the calling of a stockholder meeting
for the purpose of this Subsection 2.1.
2.2 Board
Composition. Each of the Stockholders hereby agrees to vote all of its Shares now owned or hereafter acquired by such Stockholder
(and to attend, in person or by proxy, all meetings of stockholders called for the purpose of electing directors), and agrees
to take all actions (including, but not limited, the nomination of specified persons, the execution of written consents and the
calling of a stockholder meeting for the purpose of electing such specified persons), to elect and maintain the following persons
as directors on the Board:
(a) Two
(2) persons designated from time to time by Oramed, for so long as Oramed continues to beneficially own greater than 25% of the
fully diluted capitalization of the Company; provided that one of such persons will be the then-existing chief executive officer
of Oramed who shall serve as the chairman of the Board; and
(b) One
(1) person designated from time to time by Akers (such director referred to as “Akers Designee”); provided,
however, that, on or after the third (3rd) anniversary of the date hereof, Akers shall not have the right to
designate the Akers Designee and each of the Stockholders shall be entitled to remove the Akers Designee pursuant to Subsection
2.4.
2.3 Failure
to Designate a Board Member. In the absence of any designation from the applicable Stockholder(s), the director previously
designated by them and then serving shall be reelected if still eligible and willing to serve as provided herein and otherwise,
such Board seat shall remain vacant.
2.4 Removal
of Board Members. Each Stockholder also agrees to vote, or cause to be voted, all of its Shares now owned or hereafter acquired
by such Stockholder or over which such Stockholder has voting control, from time to time and at all times, in whatever manner
as shall be necessary (and attend, in person or by proxy, all meetings of stockholders called for the purpose of electing directors),
and agree to take all actions (including, but not limited to, the execution of written consents and the calling of a stockholder
meeting) to ensure that:
(a) no
director elected pursuant to Subsections 2.2 or 2.3 of this Agreement may be removed from office unless (i) such
removal is directed or approved by the Requisite Stockholders; or (ii) the Stockholders originally entitled to designate or approve
such director pursuant to Subsection 2.2 are no longer so entitled to designate or approve such director;
(b) any
vacancies created by the resignation, removal or death of a director elected pursuant to Subsections 2.2 or 2.3 shall
be filled pursuant to the provisions of this Section 2; and
(c) upon
the request of the Requisite Stockholders to remove such director, such director shall be removed.
All
Stockholders agree to execute any written consents required to perform the obligations of this Section 2, and the Company
agrees at the request of any Person or group entitled to designate directors to call a special meeting of stockholders for the
purpose of electing directors.
2.5 No
Liability for Election of Recommended Directors. No Stockholder, nor any Affiliate of any Stockholder, shall have any liability
as a result of designating a person for election as a director for any act or omission by such designated person in his or her
capacity as a director of the Company, nor shall any Stockholder have any liability as a result of voting for any such designee
in accordance with the provisions of this Agreement.
2.6 Other
Matters. In addition to the election of directors contemplated by this Section 2, each Stockholder also agrees to vote
or cause to be voted all Shares owned by such Stockholder, or over which such Stockholder has voting control, from time to time
and at all times, in whatever manner as shall be necessary, in the same manner and to the same extent as directed by the Requisite
Stockholders.
3. “Bad
Actor” Matters.
3.1 Definitions.
For purposes of this Agreement:
(a) “Company
Covered Person” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under
the Securities Act, any Person listed in the first paragraph of Rule 506(d)(1).
(b) “Disqualified
Designee” means any director designee to whom any Disqualification Event is applicable, except for a Disqualification
Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable.
(c) “Disqualification
Event” means a “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) promulgated under the
Securities Act.
(d) “Rule
506(d) Related Party” means, with respect to any Person, any other Person that is a beneficial owner of such first Person’s
securities for purposes of Rule 506(d) under the Securities Act.
3.2 Representations.
Each Person with the right to designate or participate in the designation of a director pursuant to this Agreement hereby represents
that (a) such Person has exercised reasonable care to determine whether any Disqualification Event is applicable to such Person,
any director designee designated by such Person pursuant to this Agreement or any of such Person’s Rule 506(d) Related Parties,
except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable and (b) no
Disqualification Event is applicable to such Person, any Board member designated by such Person pursuant to this Agreement or
any of such Person’s Rule 506(d) Related Parties, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii)
or (c) or (d)(3) is applicable. Notwithstanding anything to the contrary in this Agreement, each Stockholder makes no representation
regarding any Person that may be deemed to be a beneficial owner of the Company’s voting equity securities held by such
Stockholder solely by virtue of that Person being or becoming a party to (x) this Agreement, as may be subsequently amended, or
(y) any other contract or written agreement to which the Company and such Stockholder are parties regarding (1) the voting power,
which includes the power to vote or to direct the voting of, such security; and/or (2) the investment power, which includes the
power to dispose, or to direct the disposition of, such security. The Company hereby represents and warrants to the Stockholders
that no Disqualification Event is applicable to the Company or, to the Company’s knowledge, any Company Covered Person,
except for a Disqualification Event as to which Rule 506(d)(2)(ii–iv) or (d)(3) is applicable.
3.3 Covenants.
Each Person with the right to designate or participate in the designation of a director pursuant to this Agreement covenants and
agrees (a) not to designate or participate in the designation of any director designee who, to such Person’s knowledge,
is a Disqualified Designee, (b) to exercise reasonable care to determine whether any director designee designated by such person
is a Disqualified Designee, (c) that in the event such Person becomes aware that any individual previously designated by any such
Person is or has become a Disqualified Designee, such Person shall as promptly as practicable take such actions as are necessary
to remove such Disqualified Designee from the Board and designate a replacement designee who is not a Disqualified Designee, and
(d) to notify the Company promptly in writing in the event a Disqualification Event becomes applicable to such Person or any of
its Rule 506(d) Related Parties, or, to such Person’s knowledge, to such Person’s initial designee named in Section
2, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable.
4. Agreement
Among the Company and the Stockholders.
4.1 Right
of First Refusal.
(a) Grant.
Subject to the terms of Subsections 4.2 and 4.4 below, each Stockholder hereby unconditionally and irrevocably grants
to the Company a Right of First Refusal to purchase all or any portion of Transfer Stock that such Stockholder may propose to transfer
in a Proposed Stockholder Transfer, at the same price and on the same terms and conditions as those offered to the Prospective
Transferee.
(b) Notice.
Each Stockholder proposing to make a Proposed Stockholder Transfer must deliver a Proposed Transfer Notice to the Company and each
other Stockholder not later than forty-five (45) days prior to the consummation of such Proposed Stockholder Transfer. Such Proposed
Transfer Notice shall contain the material terms and conditions (including price and form of consideration) of the Proposed Stockholder
Transfer, the identity of the Prospective Transferee and the intended date of the Proposed Stockholder Transfer. To exercise its
Right of First Refusal under this Subsection 4.1, the Company must deliver a Company Notice to the selling Stockholder and
the other Stockholders within fifteen (15) days after delivery of the Proposed Transfer Notice specifying the number of shares
of Transfer Stock to be purchased by the Company. In the event of a conflict between this Agreement and any other agreement that
may have been entered into by a Stockholder with the Company that contains a preexisting right of first refusal, the Company and
the Stockholder acknowledge and agree that the terms of this Agreement shall control and the preexisting right of first refusal
shall be deemed satisfied by compliance with Subsection 4.1(a) and this Subsection 4.1(b). In the event of a conflict
between this Agreement and the Company’s Bylaws, as amended, containing a preexisting right of first refusal, the terms of
the Bylaws, as amended, will control and compliance with the Bylaws, as amended, shall be deemed compliance with Subsection
4.1(a) and this Subsection 4.1(b).
(c) Grant
of Secondary Refusal Right to the Stockholders. Subject to the terms of Section 4.4 below, each Stockholder hereby unconditionally
and irrevocably grants to the other Stockholders a Secondary Refusal Right to purchase all or any portion of the Transfer Stock
not purchased by the Company pursuant to the Right of First Refusal, as provided in this Subsection 4.1(c). If the Company
does not provide the Company Notice exercising its Right of First Refusal with respect to all Transfer Stock subject to a Proposed
Stockholder Transfer, the Company must deliver a Secondary Notice to the selling Stockholder and to each other Stockholder to that
effect no later than fifteen (15) days after the selling Stockholder delivers the Proposed Transfer Notice to the Company. To exercise
its Secondary Refusal Right, a Stockholder must deliver a Stockholder Notice to the selling Stockholder and the Company within
ten (10) days after the Company’s deadline for its delivery of the Secondary Notice as provided in the preceding sentence.
(d) Undersubscription
of Transfer Stock. If options to purchase have been exercised by the Company and the other Stockholders pursuant to Subsections
4.1(b) and 4.1(c) with respect to some but not all of the Transfer Stock by the end of the ten (10) day period specified
in the last sentence of Subsection 4.1(c) (the “Stockholder Notice Period”), then the Company shall,
immediately after the expiration of the Stockholder Notice Period, send written notice (the “Company Undersubscription
Notice”) to those Stockholders who fully exercised their Secondary Refusal Right within the Stockholder Notice Period
(the “Exercising Stockholders”). Each Exercising Stockholder shall, subject to the provisions of this Subsection
4.1(d), have an additional option to purchase all or any part of the balance of any such remaining unsubscribed shares of Transfer
Stock on the terms and conditions set forth in the Proposed Transfer Notice. To exercise such option, an Exercising Stockholder
must deliver an Undersubscription Notice to the selling Stockholder and the Company within ten (10) days after the expiration of
the Stockholder Notice Period. In the event there are two (2) or more such Exercising Stockholders that choose to exercise the
last-mentioned option for a total number of remaining shares in excess of the number available, the remaining shares available
for purchase under this Subsection 4.1(d) shall be allocated to such Exercising Stockholders pro rata based on the proportion
that the Shares held by an Exercising Stockholder bears to the Shares held by all Exercising Stockholders who wish to purchase
the remaining unsubscribed shares of Transfer Stock, provided that no Exercising Stockholders shall be obligated to purchase more
than the number of shares initially subscribed for. If the options to purchase the remaining shares are exercised in full by the
Exercising Stockholders, the Company shall immediately notify all of the Exercising Stockholders and the selling Stockholder of
that fact.
(e) Consideration;
Closing. If the consideration proposed to be paid for the Transfer Stock is in property, services or other non-cash consideration,
the fair market value of the consideration shall be as determined in good faith by the Board and as set forth in the Company Notice.
If the Company or any Stockholder cannot for any reason pay for the Transfer Stock in the same form of non-cash consideration,
the Company or such Stockholder may pay the cash value equivalent thereof, as determined in good faith by the Board and as set
forth in the Company Notice. The closing of the purchase of Transfer Stock by the Company and the Stockholders shall take place,
and all payments from the Company and the Stockholders shall have been delivered to the selling Stockholder, by the later of (i)
the date specified in the Proposed Transfer Notice as the intended date of the Proposed Stockholder Transfer; and (ii) forty-five
(45) days after delivery of the Proposed Transfer Notice.
4.2 Right
of Co-Sale.
(a) Exercise
of Right. If any Transfer Stock subject to a Proposed Stockholder Transfer is not purchased pursuant to Subsection 4.1
above and thereafter is to be sold to a Prospective Transferee, each respective Stockholder may elect to exercise its Right of
Co-Sale and participate on a pro rata basis in the Proposed Stockholder Transfer as set forth in Subsection 4.2(b) below
and, subject to Subsection 4.2(d), otherwise on the same terms and conditions specified in the Proposed Transfer Notice.
Each Stockholder who desires to exercise its Right of Co-Sale (each, a “Participating Stockholder”) must give
the selling Stockholder written notice to that effect within fifteen (15) days after the deadline for delivery of the Secondary
Notice described above, and upon giving such notice such Participating Stockholder shall be deemed to have effectively exercised
the Right of Co-Sale.
(b) Shares
Includable. Each Participating Stockholder may include in the Proposed Stockholder Transfer all or any part of such Participating
Stockholder’s Capital Stock equal to the product obtained by multiplying (i) the aggregate number of shares of Transfer
Stock subject to the Proposed Stockholder Transfer (excluding shares purchased by the Company or the Participating Stockholders
pursuant to the Right of First Refusal or the Secondary Refusal Right) by (ii) a fraction, the numerator of which is the number
of shares of Capital Stock owned by such Participating Stockholder immediately before consummation of the Proposed Stockholder
Transfer (including any shares that such Participating Stockholder has agreed to purchase pursuant to the Secondary Refusal Right)
and the denominator of which is the total number of shares of Capital Stock owned, in the aggregate, by all Participating Stockholders
immediately prior to the consummation of the Proposed Stockholder Transfer (including any shares that all Participating Stockholders
have collectively agreed to purchase pursuant to the Secondary Refusal Right), plus the number of shares of Transfer Stock held
by the selling Stockholder.
(c) Purchase
and Sale Agreement. The Participating Stockholders and the selling Stockholder agree that the terms and conditions of any Proposed
Stockholder Transfer in accordance with this Subsection 4.2 will be memorialized in, and governed by, a written purchase
and sale agreement with the Prospective Transferee (the “Purchase and Sale Agreement”) with customary terms
and provisions for such a transaction, and the Participating Stockholders and the selling Stockholder further covenant and agree
to enter into such Purchase and Sale Agreement as a condition precedent to any sale or other transfer in accordance with this Subsection
4.2.
(d) Allocation
of Consideration.
(i) Subject
to Subsection 4.2(d)(ii), the aggregate consideration payable to the Participating Stockholders and the selling Stockholder
shall be allocated based on the number of shares of Capital Stock sold to the Prospective Transferee by each Participating Stockholder
and the selling Stockholder as provided in Subsection 4.2(b), provided that if a Participating Stockholder wishes
to sell preferred stock of the Company, if any, the price set forth in the Proposed Transfer Notice shall be appropriately adjusted
based on the conversion ratio of the preferred stock into Common Stock.
(ii) In
the event that the Proposed Stockholder Transfer constitutes a Change of Control, the terms of the Purchase and Sale Agreement
shall provide that the aggregate consideration from such transfer shall be allocated to the Participating Stockholders and the
selling Stockholder on a pro rata basis in accordance with their respective percentage ownership of the Capital Stock of the Company,
on a fully diluted basis or as otherwise set forth in the Charter.
(e) Purchase
by Selling Stockholder; Deliveries. Notwithstanding Subsection 4.2(c) above, if any Prospective Transferee or Transferees
refuse(s) to purchase securities subject to the Right of Co-Sale from any Participating Stockholder or Stockholders or upon the
failure to negotiate in good faith a Purchase and Sale Agreement reasonably satisfactory to the Participating Stockholders, no
Stockholder may sell any Transfer Stock to such Prospective Transferee or Transferees unless and until, simultaneously with such
sale, such Stockholder purchases all securities subject to the Right of Co-Sale from such Participating Stockholder or Stockholders
on the same terms and conditions (including the proposed purchase price) as set forth in the Proposed Transfer Notice and as provided
in Subsection 4.2(d)(i); provided, however, if such sale constitutes a Change of Control, the portion
of the aggregate consideration paid by the selling Stockholder to such Participating Stockholder or Stockholders shall be made
in accordance with the first sentence of Subsection 4.2(d)(ii). In connection with such purchase by the selling Stockholder,
such Participating Stockholder or Stockholders shall deliver to the selling Stockholder any stock certificate or certificates,
properly endorsed for transfer, representing the Capital Stock being purchased by the selling Stockholder (or request that the
Company effect such transfer in the name of the selling Stockholder). Any such shares transferred to the selling Stockholder will
be transferred to the Prospective Transferee against payment therefor in consummation of the sale of the Transfer Stock pursuant
to the terms and conditions specified in the Proposed Transfer Notice, and the selling Stockholder shall concurrently therewith
remit or direct payment to each such Participating Stockholder the portion of the aggregate consideration to which each such Participating
Stockholder is entitled by reason of its participation in such sale as provided in this Subsection 4.2(e).
(f) Additional
Compliance. If any Proposed Stockholder Transfer is not consummated within sixty (60) days after receipt of the Proposed Transfer
Notice by the Company, the Stockholders proposing the Proposed Stockholder Transfer may not sell any Transfer Stock unless they
first comply in full with each provision of this Subsection 4.2. The exercise or election not to exercise any right by any
Stockholder hereunder shall not adversely affect its right to participate in any other sales of Transfer Stock subject to this
Subsection 4.2.
4.3 Effect
of Failure to Comply.
(g) Transfer
Void; Equitable Relief. Any Proposed Stockholder Transfer not made in compliance with the requirements of this
Agreement shall be null and void ab initio, shall not be recorded on the books of the Company or its transfer agent and shall
not be recognized by the Company. Each party hereto acknowledges and agrees that any breach of this Agreement would result in
substantial harm to the other parties hereto for which monetary damages alone could not adequately compensate. Therefore, the
parties hereto unconditionally and irrevocably agree that any non-breaching party hereto shall be entitled to seek protective
orders, injunctive relief and other remedies available at law or in equity (including, without limitation, seeking specific
performance or the rescission of purchases, sales and other transfers of Transfer Stock not made in strict compliance with
this Agreement).
(h) Violation
of First Refusal Right. If any Stockholder becomes obligated to sell any Transfer Stock to the Company or any other Stockholder
under this Agreement and fails to deliver such Transfer Stock in accordance with the terms of this Agreement, the Company and/or
such other Stockholder may, at its option, in addition to all other remedies it may have, send to such selling Stockholder the
purchase price for such Transfer Stock as is herein specified and transfer to the name of the Company or such other Stockholder
(or request that the Company effect such transfer in the name of a Stockholder) on the Company’s books any certificates,
instruments, or book entry representing the Transfer Stock to be sold.
(i) Violation
of Co-Sale Right. If any Stockholder purports to sell any Transfer Stock in contravention of the Right of Co-Sale (a “Prohibited
Transfer”), each Participating Stockholder who desires to exercise its Right of Co-Sale under Subsection 4.2 may,
in addition to such remedies as may be available by law, in equity or hereunder, require such Stockholder to purchase from such
Participating Stockholder the type and number of shares of Capital Stock that such Participating Stockholder would have been entitled
to sell to the Prospective Transferee had the Prohibited Transfer been effected in compliance with the terms of Subsection 4.2.
The sale will be made on the same terms, including, without limitation, as provided in Subsection 4.2(d)(i) and the first
sentence of Subsection 4.2(d)(ii), as applicable, and subject to the same conditions as would have applied had the Stockholder
not made the Prohibited Transfer, except that the sale (including, without limitation, the delivery of the purchase price) must
be made within ninety (90) days after the Participating Stockholder learns of the Prohibited Transfer, as opposed to the timeframe
proscribed in Subsection 4.2. Such Stockholder shall also reimburse each Participating Stockholder for any and all
reasonable and documented out-of-pocket fees and expenses, including reasonable legal fees and expenses, incurred pursuant to the
exercise or the attempted exercise of the Participating Stockholder’s rights under Subsection 4.2.
4.4 Exempt
Transfers.
(j) Notwithstanding
the foregoing or anything to the contrary herein, the provisions of Subsections 4.1 and 4.2 shall not apply (i) in
the case of a Stockholder that is an entity, upon a transfer by such Stockholder to its stockholders, members, partners or other
equity holders or to any Affiliates of such Stockholder, including, without limitation, any transfer relating to or in respect
of the Spin Off (which Spin Off, for the avoidance of doubt, the parties hereto acknowledge and agree is an exempt transfer not
subject to any of the provisions of Section 4), (ii) to a repurchase of Transfer Stock from a Stockholder by the Company,
or (iii) in the case of a Stockholder that is a natural person, upon a transfer of Transfer Stock by such Stockholder made for
bona fide estate planning purposes, either during his or her lifetime or on death by will or intestacy to his or her spouse, child
(natural or adopted), or any other direct lineal descendant of such Stockholder (or his or her spouse) (all of the foregoing collectively
referred to as “family members”), or any custodian or trustee of any trust, partnership or limited liability company
for the benefit of, or the ownership interests of which are owned wholly by such Stockholder or any such family members; provided
that in the case of clause(s) (i), (iii) or (iv), the Stockholder shall deliver prior written notice to the Company and the other
Stockholders of such pledge, gift, sale, assignment or transfer and such shares of Transfer Stock shall at all times remain subject
to the terms and restrictions set forth in this Agreement and such transferee shall, as a condition to such permitted transfer,
deliver a counterpart signature page to this Agreement as confirmation that such transferee shall be bound by all the terms and
conditions of this Agreement as a Stockholder (but only with respect to the securities so transferred to the transferee), including
the obligations of a Holder with respect to Proposed Stockholder Transfers of such Transfer Stock pursuant to Section 4;
and provided further in the case of any transfer pursuant to clause (i) or (iv) above, that such transfer is made pursuant
to a transaction in which there is no consideration actually paid for such transfer.
(k) Notwithstanding
the foregoing or anything to the contrary herein, the provisions of Subsections 4.1 and 4.2 shall not apply to the
sale of any Transfer Stock (i) to the public in an offering pursuant to an effective registration statement under the Securities
Act; or (ii) pursuant to a Deemed Liquidation Event.
(l) Notwithstanding
the foregoing, no Stockholder shall transfer any Capital Stock to (i) any entity which, in the determination of the Board, in good
faith and upon advice of external counsel, directly or indirectly competes with the Company; or (ii) any customer, distributor
or supplier of the Company, if the Board should determine that such transfer would result in such customer, distributor or supplier
receiving information that would place the Company at a competitive disadvantage with respect to such customer, distributor or
supplier.
4.5 Rights
to Future Stock Issuances.
(m) Subject
to the terms and conditions of this Subsection 4.5(a) and applicable securities laws, if the Company proposes to offer or
sell any New Securities, the Company shall first offer such New Securities to each Stockholder that is an “accredited investor”
(as defined in Rule 501(a) under the Securities Act). A Stockholder shall be entitled to apportion the right of first offer hereby
granted to it in such proportions as it deems appropriate among (i) itself, and (ii) its Affiliates.
(n) The
Company shall give notice (the “Offer Notice”) to each Stockholder, stating (i) its bona fide intention to offer
such New Securities, (ii) the number of such New Securities to be offered, and (iii) the price and terms, if any, upon which it
proposes to offer such New Securities.
(o) By
notification to the Company within twenty (20) days after the Offer Notice is given, each Stockholder may elect to purchase or
otherwise acquire, at the price and on the terms specified in the Offer Notice, up to that portion of such New Securities which
equals the proportion that the Common Stock then held by such Stockholder (including all shares of Common Stock then issuable (directly
or indirectly) upon conversion and/or exercise, as applicable, of any Derivative Securities then held by such Stockholder) bears
to the total Common Stock of the Company then issued and outstanding (assuming full conversion and/or exercise, as applicable,
of any Derivative Securities then outstanding). At the expiration of such twenty (20) day period, the Company shall promptly notify
each Stockholder that elects to purchase or acquire all the shares available to it (each, a “Fully Exercising Investor”)
of any other Stockholder’s failure to do likewise. During the ten (10) day period commencing after the Company has given
such notice, each Fully Exercising Investor may, by giving notice to the Company, elect to purchase or acquire, in addition to
the number of shares specified above, up to that portion of the New Securities for which Stockholders were entitled to subscribe
but that were not subscribed for by the Stockholders which is equal to the proportion that the Common Stock issued and held, or
issuable (directly or indirectly) upon conversion and/or exercise, as applicable, of any Derivative Securities then held, by such
Fully Exercising Investor bears to the Common Stock issued and held, or issuable (directly or indirectly) upon conversion and/or
exercise, as applicable, of any Derivative Securities then held, by all Fully Exercising Investors who wish to purchase such unsubscribed
shares. The closing of any sale pursuant to this Subsection 4.5(b) shall occur within the later of ninety (90) days of the
date that the Offer Notice is given and the date of initial sale of New Securities pursuant to Subsection 4.5(d).
(p) If
all New Securities referred to in the Offer Notice are not elected to be purchased or acquired as provided in Subsection 4.5(c),
the Company may, during the ninety (90) day period following the expiration of the periods provided in Subsection 4.5(c),
offer and sell the remaining unsubscribed portion of such New Securities to any Person or Persons at a price not less than, and
upon terms no more favorable to the offeree than, those specified in the Offer Notice. If the Company does not enter into an agreement
for the sale of the New Securities within such period, or if such agreement is not consummated within thirty (30) days of the execution
thereof, the right provided hereunder shall be deemed to be revived and such New Securities shall not be offered unless first reoffered
to the Stockholders in accordance with this Subsection 4.5.
(q) The
right of first offer in this Subsection 4.5 shall not be applicable to (i) shares of Common Stock issued in the IPO, and
(ii) any New Securities as to which the rights of the Stockholders under this Subsection 4.5 have been waived by the affirmative
vote (including by written consent) of the Requisite Stockholders.
4.6 Other
Stockholder Rights/Obligations.
(r) The
Company shall permit each Stockholder, at such Stockholder’s expense, to visit and inspect the Company’s properties;
examine its books of account and records; and discuss the Company’s affairs, finances, and accounts with its officers, during
normal business hours of the Company as may be reasonably requested by the Stockholder; provided, however, that the
Company shall not be obligated pursuant to this Subsection 4.6 to provide access to any information that the Board, upon
advice of counsel, reasonably and in good faith considers to be a trade secret or confidential information (unless covered by an
enforceable confidentiality agreement, in form acceptable to the Company) or the disclosure of which would adversely affect the
attorney-client privilege between the Company and its counsel.
(s) The
Company shall deliver to each Stockholder: (i) as soon as practicable, but in any event within ninety (90) days after the end of
each fiscal year of the Company (A) an audited balance sheet as of the end of such year, (B) audited statements of income and of
cash flows for such year, and (C) an audited statement of stockholders’ equity as of the end of such year; (ii) as soon as
practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each fiscal
year of the Company, unaudited statements of income and cash flows for such fiscal quarter, and an unaudited balance sheet and
a statement of stockholders’ equity as of the end of such fiscal quarter, all prepared in accordance with GAAP (except that
such financial statements may (A) be subject to normal year-end audit adjustments; and (B) not contain all notes thereto that may
be required in accordance with GAAP); (iii) as soon as practicable, but in any event within thirty (30) days of the end of each
month, an unaudited income statement and statement of cash flows for such month, and an unaudited balance sheet and statement of
stockholders’ equity as of the end of such month, all prepared in accordance with GAAP (except that such financial statements
may (A) be subject to normal year-end audit adjustments, and (B) not contain all notes thereto that may be required in accordance
with GAAP); (iv) as soon as practicable, but in any event thirty (30) days before the end of each fiscal year, a budget and business
plan for the next fiscal year (collectively, the “Budget”), approved by the Board, promptly after prepared,
any other budgets or revised budgets prepared by the Company; and (v) such other information relating to the financial condition,
business, prospects, or corporate affairs of the Company as any Stockholder may from time to time reasonably request.; provided,
however, that the Company shall not be obligated under this Subsection 4.6(b) to provide information (A) that the
Company reasonably determines in good faith to be a trade secret or confidential information (unless covered by an enforceable
confidentiality agreement, in a form acceptable to the Company); or (B) the disclosure of which would adversely affect the attorney-client
privilege between the Company and its counsel. If, for any period, the Company has any subsidiary whose accounts are consolidated
with those of the Company, then in respect of such period the financial statements delivered pursuant to the foregoing sections
shall be the consolidated and consolidating financial statements of the Company and all such consolidated subsidiaries. Notwithstanding
anything else in this Subsection 4.6(b) to the contrary, the Company may cease providing the information set forth in this
Subsection 4.6(b) during the period starting with the date thirty (30) days before
the Company’s good-faith estimate of the date of filing of a registration statement if it reasonably concludes it must do
so to comply with the SEC rules applicable to such registration statement and related offering; provided that the Company’s
covenants under this Subsection 4.6(b) shall be reinstated at such time as the Company is no longer actively employing its
commercially reasonable efforts to cause such registration statement to become effective.
(t) Each
of the Premas Parties shall comply, and Akers shall comply and shall cause Cystron to comply with its obligations, covenants and
agreements in the Contribution Agreement, including, without limitation: (i) the obligations, covenants and agreements set forth
in Section 3 thereof in respect of any Royalty Payments (as defined therein), and (ii) the obligations, covenants and agreements
set forth in Section 5 thereof, including, without limitation, in respect of the consummation of the Qualified Financing as soon
as practicable, but no later than 3 months, following the effective date of the Contribution Agreement.
(u) Oramed
shall comply with its obligations, covenants and agreements in the Oramed License Agreement, and its commitment to a Qualified
Financing as soon as practicable, but no later than the time specified in the Oramed License Agreement.
(v) Confidentiality.
Each Stockholder agrees that such Stockholder will keep confidential and will not disclose, divulge, or use for any purpose (other
than to monitor or make decisions with respect to its investment in the Company) any confidential information obtained from the
Company pursuant to the terms of this Agreement, unless such confidential information (a) is known or becomes known to the public
in general (other than as a result of a breach of this Section 4.6(e) by such Stockholder),(b) is or has been independently
developed or conceived by such Stockholder without use of the Company’s confidential information, or (c) is or has been made
known or disclosed to such Stockholder by a third party without a breach of any obligation of confidentiality such third party
may have to the Company; provided, however, that an Stockholder may disclose confidential information (i) to its
attorneys, accountants, consultants, and other professionals to the extent reasonably necessary to obtain their services in connection
with monitoring its investment in the Company; (ii) to any prospective purchaser of any Capital Stock from such Stockholder, if
such prospective purchaser agrees to be bound by the provisions of this Section 4.6(e), and provided that in no event shall
such information be disclosed to a competitor of the Company, as determined by the Board; (iii) to any Affiliate, partner,
member, stockholder, or wholly owned subsidiary of such Stockholder in the ordinary course of business, provided that such
Stockholder informs such Person that such information is confidential and directs such Person to maintain the confidentiality of
such information; or (iv) as may otherwise be required by law, regulation, rule, court order or subpoena, provided that
such Stockholder promptly notifies the Company of such disclosure and takes reasonable steps to minimize the extent of any such
required disclosure. Without derogating from the foregoing it is clarified that the aforesaid shall not prevent any Stockholder
from (A) entering into any business, entering into any agreement with a third party, or investing in or engaging in investment
discussions with any other company (whether or not competitive with the Company), provided, that, except as expressly permitted
under the terms of this Section 4.6(d), such Stockholder does not and shall not, in any way whatsoever, disclose or otherwise
make use of or reference to any proprietary or confidential information of the Company in connection with such activities; or (B)
making any disclosures required by law, rule, regulation or court or other governmental order.
5. Spin
Off. If requested by Akers, and if approved by the Board of the Company, the Company will cooperate with Akers in effecting
the Spin Off, including, without limitation, by making such applications to the Nasdaq Stock Market or other national securities
exchange for the listing of the Common Stock thereon and taking other commercially reasonable actions reasonably necessary or appropriate
for the consummation of the Spin Off.
6. Matters
Requiring Minority Stockholder Approval. For so long as any Stockholder holds at least 10% of the Company's issued and outstanding
share capital, the Company hereby covenants and agrees with each of the Stockholders that the Company shall not, without approval
of such Stockholder:
(a) change
the principal business of the Company or exit the current line of business;
(b) sell,
assign, license, pledge, or encumber all or substantially all of the intellectual property of the Company;
(c) liquidate,
dissolve or wind-up the business and affairs of the Company or effect any Deemed Liquidation Event; or
(d)
otherwise enter into or be a party to any transaction with any director, officer or employee of the Company or any “associate”
(as defined in Rule 12b-2 promulgated under the Exchange Act) of any such Person, including without limitation any “management
bonus” or similar plan providing payments to employees in connection with a Deemed Liquidation Event, as such term is defined
in the Certificate of Incorporation, except for transactions made in the ordinary course of business and pursuant to reasonable
requirements of the Company’s business.
In
addition, the Company shall not amend the initial Budget established pursuant to Section 6(b) of the Contribution Agreement without
the prior written agreement of Akers during a period of six (6) months from the date of this Agreement.
7. Term.
This Agreement shall be effective as of the date hereof and shall continue in effect until and shall terminate upon the earliest
to occur of (a) a Going Public Event; (b) the consummation of a Sale of the Company and distribution of proceeds to or escrow
for the benefit of the Stockholders in accordance with the Charter; (c) a Deemed Liquidation Event; and (d) termination of this
Agreement in accordance with Subsection 8.8 below.
8. Miscellaneous.
8.1 Additional
Parties. Notwithstanding anything to the contrary contained herein, if the Company issues additional shares of Capital Stock
after the date hereof, following which any Person shall hold Shares constituting one percent (1%) or more of the Company’s
then outstanding Capital Stock (treating for this purpose all shares of Common Stock issuable upon exercise of or conversion of
outstanding options, warrants or convertible securities, as if exercised and/or converted or exchanged), then, the Company shall
cause such Person, as a condition precedent to entering into such agreement, to become a party to this Agreement by executing
an Adoption Agreement in the form attached hereto as Exhibit A, agreeing to be bound by and subject to the terms of this
Agreement as a Stockholder and thereafter such Person shall be deemed a Stockholder for all purposes under this Agreement. In
addition, the Company may cause any other Person who acquired Capital Stock to become a party to this Agreement by executing an
Adoption Agreement in the form attached hereto as Exhibit A.
8.2 Transfers.
Each transferee or assignee of any Shares subject to this Agreement shall be subject to the terms hereof, and, as a condition
precedent to the Company’s recognition of such transfer, each transferee or assignee shall agree in writing to be bound
by and subject to each of the terms of this Agreement by executing and delivering an Adoption Agreement substantially in the form
attached hereto as Exhibit A. Upon the execution and delivery of an Adoption Agreement by any transferee, such transferee
shall be deemed to be a party hereto as if such transferee were the transferor and such transferee’s signature appeared
on the signature pages of this Agreement and shall be deemed to be a Stockholder. By execution and delivery of a counterpart signature
page to this Agreement, each of the parties appoint the Company as its attorney-in-fact for the purpose of executing any Adoption
Agreement that may be required to be delivered under the terms of this Agreement. The Company shall not permit the transfer of
the Shares subject to this Agreement on its books or issue a new certificate representing any such Shares unless and until such
transferee shall have complied with the terms of this Subsection 8.2. Each certificate instrument, or book entry representing
the Shares subject to this Agreement if issued on or after the date of this Agreement shall be notated by the Company with the
legend set forth in Subsection 8.12.
8.3 Successors
and Assigns. The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors
and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the
parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason
of this Agreement, except as expressly provided in this Agreement. The rights of the Stockholders hereunder are not assignable
without the Company’s written consent (which shall not be unreasonably withheld, delayed or conditioned), except (a) by
a Stockholder to any Affiliate, (b) by a Stockholder to any of its stockholders in connection with the Spin-Off, or (c) by a Stockholder
to another Stockholder, it being acknowledged and agreed that any such assignment, including an assignment contemplated by the
preceding clauses (a) through (c), shall be subject to and conditioned upon any such assignee’s delivery to the Company
and the other Stockholders of a counterpart signature page hereto pursuant to which such assignee shall confirm their agreement
to be subject to and bound by all of the provisions set forth in this Agreement that were applicable to the assignor of such assignee.
Except in connection with an assignment by the Company by operation of law to the acquirer of the Company, the rights and obligations
of the Company under this Agreement may not be assigned under any circumstances; provided, that the Company’s Right
of First Refusal may be transferred or assigned with the approval of the Requisite Stockholders.
8.4 Governing
Law. This Agreement and any controversy arising out of or relating to this Agreement shall be governed by and construed in
accordance with the General Corporation Law of the State of Delaware, without regard to conflict of law principles that would
result in the application of any law other than the law of the State of Delaware.
8.5 Counterparts;
Delivery. This Agreement may be (a) executed in two (2) or more counterparts, each of which shall be deemed an original, but
all of which together shall constitute one and the same instrument; and (b) executed by electronic signature which shall be deemed
an original signature. Any signatures, counterparts or otherwise may be delivered via facsimile, electronic mail (including pdf
or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission
method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for
all purposes.
8.6 Titles
and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered
in construing or interpreting this Agreement.
8.7 Notices.
(a) All
notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given
upon the earlier of actual receipt or (a) personal delivery to the party to be notified, (b) when sent, if sent by electronic mail
or facsimile during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s
next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage
prepaid, or (d) one (1) business day after the business day of deposit with a nationally recognized overnight courier, freight
prepaid, specifying next business day delivery, with written verification of receipt. All communications shall be sent to the respective
parties at their address as set forth on Schedule A hereto, or to such email address, facsimile number or address as subsequently
modified by written notice given in accordance with this Subsection 8.7.
(b) Consent
to Electronic Notice. Each Stockholder consents to the delivery of any stockholder notice pursuant to the Delaware General
Corporation Law (the “DGCL”), as amended or superseded from time to time, by electronic transmission pursuant
to Section 232 of the DGCL (or any successor thereto) at the electronic mail address or the facsimile number set forth below such
Stockholder’s name on the Schedule hereto, as updated from time to time by notice to the Company, or as on the books of the
Company. To the extent that any notice given by means of electronic transmission is returned or undeliverable for any reason, the
foregoing consent shall be deemed to have been revoked until a new or corrected electronic mail address has been provided, and
such attempted Electronic Notice shall be ineffective and deemed to not have been given. Each Stockholder agrees to promptly notify
the Company of any change in its electronic mail address, and that failure to do so shall not affect the foregoing.
8.8 Consent
Required to Amend, Terminate or Waive. This Agreement may be amended or terminated (other than pursuant to Section 8)
and the observance of any term hereof may be waived (either generally or in a particular instance and either retroactively or
prospectively) only by a written instrument executed by (a) the Company; and (b) Requisite Stockholders, provided, however,
that if, at such time, there are no more than 5 Stockholders then such instrument shall be executed by the Stockholders representing
at least 90% of the voting power of the Common Stock, voting as a single class on an as converted basis. Notwithstanding the foregoing:
(a) this
Agreement may not be amended, modified or terminated and the observance of any term of this Agreement may not be waived with respect
to any Stockholder without the written consent of such Stockholder unless such amendment, modification, termination or waiver applies
to all Stockholders in the same fashion;
(b) Schedule
A hereto may be amended by the Company from time to time to add Stockholders pursuant to Subsection 8.1 and information
regarding additional Stockholders made parties hereto pursuant to Subsection 8.2 and permitted transferees and assignees
of Stockholders without the consent of the other parties hereto; and
(c) any
provision hereof may be waived by the waiving party on such party’s own behalf, without the consent of any other party.
The Company
shall give prompt written notice of any amendment, modification, termination, or waiver hereunder to any party that did not consent
in writing thereto. Any amendment, modification, termination, or waiver effected in accordance with this Subsection 8.8
shall be binding on each party and all of such party’s successors and permitted assigns, whether or not any such party, successor
or assignee entered into or approved such amendment, modification, termination or waiver. No waivers of or exceptions to any item,
condition or provision of this Agreement, in any one or more instances, shall be deemed to be, or construed as, a further or continuing
waiver of any such term, condition or provision.
8.9 Delays
or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party under this Agreement, upon
any breach or default of any other party under this Agreement, shall impair any such right, power or remedy of such non-breaching
or non-defaulting party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or
of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a
waiver of any other breach or default previously or thereafter occurring. Any waiver, permit, consent or approval of any kind
or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of
any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set
forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any party, shall be cumulative
and not alternative.
8.10 Severability.
The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other
provision and such invalid or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable
to the maximum extent permitted by law.
8.11 Entire
Agreement. This Agreement (including the Exhibits hereto) and the Charter constitute the full and entire understanding and
agreement between the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the
subject matter hereof (including, without limitation, any Board designation or nomination rights) existing between the parties
is expressly canceled.
8.12 Share
Certificate Legend. To the extent any Shares are issued after the date hereof to a Stockholder, each certificate, instrument,
or book entry representing any such Shares shall be notated by the Company with legends reading substantially as follows:
“The
Shares REPRESENTED hereby are subject to a stockholders Agreement, AS MAY BE AMENDED FROM TIME TO TIME, (a copy of which may be
obtained upon written request from the Company), and by accepting any interest in such Shares the person accepting such interest
shall be deemed to agree to and shall become bound by all the provisions of that stockholders Agreement, including certain restrictions
on transfer and ownership set forth therein.”
The Company,
by its execution of this Agreement, agrees that it will cause the certificates instruments, or book entry evidencing the Shares
issued after the date hereof to a Stockholder to bear the legend required by this Subsection 8.12 of this Agreement, and
it shall supply, free of charge, a copy of this Agreement to any holder of such Shares upon written request from such holder to
the Company at its principal office. The parties to this Agreement do hereby agree that the failure to cause the certificates,
instruments, or book entry evidencing the Shares to bear the legend required by this Subsection 8.12 herein and/or the failure
of the Company to supply, free of charge, a copy of this Agreement as provided hereunder shall not affect the validity or enforcement
of this Agreement.
8.13 Stock
Splits, Stock Dividends, etc. In the event of any issuance of Shares of the voting securities of the Company hereafter to
any of the Stockholders (including, without limitation, in connection with any stock split, stock dividend, recapitalization,
reorganization, or the like), such Shares shall become subject to this Agreement and shall be notated with the legend set
forth in Subsection 8.12.
8.14 Manner
of Voting. The voting of Shares pursuant to this Agreement may be effected in person, by proxy, by written consent or in any
other manner permitted by applicable law. For the avoidance of doubt, voting of the Shares pursuant to the Agreement need not
make explicit reference to the terms of this Agreement.
8.15 Further
Assurances. At any time or from time to time after the date hereof, the parties agree to cooperate with each other, and at
the request of any other party, to execute and deliver any further instruments or documents and to take all such further action
as the other party may reasonably request in order to evidence or effectuate the consummation of the transactions contemplated
hereby and to otherwise carry out the intent of the parties hereunder.
8.16 Dispute
Resolution The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of
Delaware and to the jurisdiction of the United States District Court for the District of Wilmington for the purpose of any
suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or
other proceeding arising out of or based upon this Agreement except in the state courts of Delaware or the United States
District Court for the District of Wilmington, and (c) hereby waive, and agree not to assert, by way of motion, as a defense,
or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the
above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding
is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or
the subject matter hereof may not be enforced in or by such court.
Waiver
of Jury Trial: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING
OUT OF THIS AGREEMENT, THE OTHER TRANSACTION DOCUMENTS, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS
WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT
MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY
CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND
THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY
HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING
CONSULTATION WITH LEGAL COUNSEL.
8.17 Costs
of Enforcement. If any party to this Agreement seeks to enforce its rights under this Agreement by legal proceedings, the
non-prevailing party shall pay all reasonable costs and expenses incurred by the prevailing party, including, without limitation,
all reasonable attorneys’ fees, including on appeal.
8.18 Aggregation
of Stock. All Shares held or acquired by a Stockholder and/or its Affiliates shall be aggregated together for the purpose
of determining the availability of any rights under this Agreement, and such Affiliated persons may apportion such rights as among
themselves in any manner they deem appropriate.
[Signature
Page Follows]
IN WITNESS WHEREOF, the
parties have executed this Stockholders Agreement as of the date first written above.
COMPANY:
ORAVAX
MEdical, INC.
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By:
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/s/ Josh Silverman
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Name:
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Josh Silverman
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Title:
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Chief Executive Officer
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STOCKHOLDERS:
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AKERS BIOSCIENCES INC.
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PREMAS BIOTECH PVT LTD.
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By:
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/s/ Christopher Schreiber
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By:
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/s/ Prabuddha Kundu
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Name:
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Christopher Schreiber
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Name:
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Prabuddha Kundu
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Title:
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Chief Executive Officer
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Title:
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Managing Director
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cutter mill capital llc
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run ridge llc
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By:
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/s/ Michael Vasinkevich
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By:
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/s/ Craig M. Schwabe
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Name:
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Michael Vasinkevich
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Name:
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Craig M. Schwabe
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Title:
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Authorized Signatory
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Title:
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Authorized Signatory
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ORAMED PHARMACEUTICALS, INC.
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By:
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/s/ Nadav Kidron
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Name:
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Nadav Kidron
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Title:
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Chief Executive Officer
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Signature
Page to Stockholders Agreement
SCHEDULE
A
STOCKHOLDERS
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Name and Address
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Number of Shares Held
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Oramed
Pharmaceuticals, Inc.
1185
AVENUE OF THE AMERICAS, 3RD FLOOR,
NEW YORK, NY, 10036
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1,890,000
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Akers
Biosciences Inc.
1185
AVENUE OF THE AMERICAS, 3RD FLOOR,
NEW YORK, NY, 10036
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390,000
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Run
Ridge LLC
430
Park Avenue, 3rd Floor
NewYork, NY 10022
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18,000
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Premas
Biotech PVT Ltd.
prabuddha.kundu@premasbiotech.com
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360,000
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Cutter
Mill Capital LLC
430
Park Avenue, 3rd Floor
NewYork, NY 10022
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342,000
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Schedule
A
EXHIBIT
A
ADOPTION
AGREEMENT
This
Adoption Agreement (“Adoption Agreement”) is executed on ___________________, 20__, by the undersigned (the
“Holder”) pursuant to the terms of that certain Stockholders Agreement dated as of March 18, 2021 (the “Agreement”),
by and among the Company and certain of its Stockholders, as such Agreement may be amended or amended and restated hereafter. Capitalized
terms used but not defined in this Adoption Agreement shall have the respective meanings ascribed to such terms in the Agreement.
By the execution of this Adoption Agreement, the Holder agrees as follows.
1.1 Acknowledgement.
Holder acknowledges that Holder is acquiring certain shares of the capital stock of the Company (the “Stock”)
or options, warrants, units or other rights to purchase such Stock (the “Options”), for one of the following
reasons (Check the correct box):
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☐
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As a transferee of Shares from a party in such party’s capacity as a “Stockholder”
bound by the Agreement, and after such transfer, Holder shall be considered a “Stockholder” for all purposes of the
Agreement.
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☐
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As a new Stockholder in accordance with Subsection 8.1 of the Agreement, in which case Holder
will be a “Stockholder” for all purposes of the Agreement.
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1.2 Agreement.
Holder hereby (a) agrees that the [Stock][Options], and any other shares of capital stock or securities required by the Agreement
to be bound thereby, shall be bound by and subject to the terms of the Agreement and (b) adopts the Agreement with the same force
and effect as if Holder were originally a party thereto.
1.3 Notice.
Any notice required or permitted by the Agreement shall be given to Holder at the address or facsimile number listed below Holder’s
signature hereto.
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HOLDER:
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ACCEPTED AND AGREED:
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By:
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ORAVAX MEDICAL INC.
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Name and Title of Signatory
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Exhibit
A
Exhibit 99.1
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations March 2021
2 Safe Harbor Certain statements contained in this material are forward - looking statements . These forward - looking statements are based on the current expectations of the management of Oramed only, including with respect to clinical trials, milestones and the potential benefits of Oramed's products, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward - looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs ; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates ; competition from other pharmaceutical or biotechnology companies ; and our ability to obtain additional funding required to conduct our research, development and commercialization activities, and others, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward - looking statements . Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward - looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events . For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission, which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward - looking statements . Please refer to the company's filings with the Securities and Exchange Commission for a comprehensive list of risk factors that could cause actual results, performance or achievements of the company to differ materially from those expressed or implied in such forward - looking statements . Oramed undertakes no obligation to update or revise any forward - looking statements .
3 Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market ▪ Robust pipeline leveraging IP portfolio for additional significant market opportunities ▪ Strong financial position over $ 56 M in cash and investments, no debt 1 ▪ Experienced management team backed by world - class scientific experts ▪ Multiple value - creation events for 2021 ▪ NASDAQ/TASE: ORMP 1 As of February 28 , 2021
4 Proprietary Technology for Oral Drug Delivery Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Therapeutic proteins fail to be absorbed via the intestinal wall (barrier) Proteins and Peptides do Not Survive the Digestive System pH shield Sensitive enteric coating protects capsule contents before entering small intestine Protease protection Protease inhibitors protect the active agent Absorption enhancement Assists the permeation of proteins/peptides across intestinal membrane and into bloodstream Oramed Technology Protects Drug Integrity and Increases Absorption
5 Phase 2 Phase 3 Multiple Clinical - Stage Programs ORMD - 0801 (Oral Insulin) Type 1 & 2 Diabetes ORMD - 0801 (Oral Insulin) NASH ORMD - 0901 (Oral GLP - 1) Type 2 Diabetes Phase 1 Exploratory Studies Leptin (T 1 DM – PD: glucose and glycogen reduction; PK)
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
7 1 in 1 1 Adults on the Planet Have Diabetes every 6 SECONDS 1 adult dies from diabetes 4 M deaths in 2017 https://www.idf.org/e - library/epidemiology - research/diabetes - atlas/ 159 - idf - diabetes - atlas - ninth - edition - 2019 .html WORLD 463 M People live with diabetes PREVALENCE 9 . 09 % 20 19 2045 MILLION expected increase: + 237 healthcare 10 % spent on diabetes In 2019 diabetes expenditure reached US $ 760 billion
ORMD - 0801: Oral Insulin
9 ORMD - 0801 - Flagship Product for Oral Treatment of Diabetes > 900 study subjects > 10,000 human doses No Serious Drug - Related Adverse Events
10 The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin ENDOGENOUS INSULIN produced by the pancreas and delivered to the body via the liver portal vein liver small intestine stomach To systemic circulation Oral insulin , like natural insulin, is delivered first to the liver, resulting in: x Better blood glucose control x Reduced hypoglycemia x Reduced hyperglycemia x No weight gain Injected Insulin introduced directly to the bloodstream, with only a fraction of it reaching the liver. This can cause excess sugar to be stored in fat and muscle which often results in weight gain and may also cause hypoglycemia.
11 TYPE 1 Diabetes TYPE 2 Diabetes ▪ T 1 DM is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources ▪ 10 % of diabetics have T 1 DM: Up to 37 million people worldwide have T 1 DM ▪ Projected Market: $ 13 billion by 2023 ▪ T 2 DM is metabolic: The body becomes insulin resistant. Injections may be used to make up for the pancreas ’ s inability to create sufficient insulin to keep blood sugar at normal levels ▪ 371 million people worldwide need treatment ▪ Projected Market: $ 59 billion by 2025 ORMD - 0801 for Type 1 & Type 2 Diabetes Diabetes inhibits the production of sufficient insulin and causes elevated levels of glucose in the blood
12 ▪ Long - acting insulin (basal) helps maintain stable insulin levels during fasting periods ▪ Rapid - acting insulin (bolus) prior to each meal to stabilize blood sugar ▪ Administration is via injection or pump ▪ Easier use and reduced systemic exposure ▪ Potentially reducing multiple daily injections ▪ Tighter regulation and control of blood sugar levels by directly targeting liver glucose ( TiR ), due to portal administration ORMD - 0801 for Type 1 Diabetes (T 1 DM) Potentially eliminating the need for insulin before each meal T 1 DM patients are treated with various types of insulin replacement therapy Oramed oral insulin
13 Decreased x use of rapid - acting insulin x levels of post - meal glucose x levels of daytime glucose Phase 2 a T 1 DM Study Consistent and Accumulative Effect of ORMD - 0801 for Treating Type 1 Diabetes Blood glucose levels lower day and night compared to control group Evaluate change in exogenous insulin requirements in T 1 DM patients Primary Endpoint: 25 T 1 DM patients 7 days of treatment 3 times a day (at mealtime) Reduction in FBG -18 -13 -8 -3 2 -70.00 -50.00 -30.00 -10.00 10.00 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Delta Basal Insulin Delta Bolus Insulin Delta FPG FPG (mg/dl) Delta Placebo vs ORMD Basal or Bolus Insulin (units) Delta Placebo vs ORMD Oral Insulin Reduces Exogenous Insulin Requirements Safe and Well Tolerated
14 Completed: 180 Patient Phase 2 Study for Type 2 Diabetes 33 US sites 28 day treatment 1 Dose (nightly) 180 patients
15 FDA Phase 2 Study Achieved Every Primary Endpoint with No Drug Related Serious Adverse Events Nighttime CGM Glucose Median mg/dl change Nighttime CGM Glucose Mean mg/dl change Nighttime CGM Glucose Mean % change * Indicates Statistically Significant Difference versus Placebo (p - Value<0.05) Last 2 days Last 2 days Last 2 days Placebo 8.48 ORMD - 0801 2.01 * Placebo 13.70 Placebo 12.38 ORMD - 0801 1.66* ORMD - 0801 - 0.35 * Change from run - in – 80 % trim
16 Daytime 6 AM to 10 PM Fasting 5 AM to 7 AM 24 Hours FDA Phase 2 Study Exploratory Endpoints: CGM Parameters Placebo P - value=<0.0001* 13.26 ORMD - 0801 P - value=< 0.0001 * - 0.32 * Placebo P - value=< 0.0001 * 15.95 Placebo P - value= 0.0010 * 11.88 ORMD - 0801 P - value=< 0.0001 * - 0.41 * ORMD - 0801 P - value= 0.0010 * 0.88 * Mean Change from Run - in Period Glucose (mg/dl) * Indicates p - Value< 0.05
17 Completed: 298 Patient Phase 2 b Trial 34 US sites* 90 Day treatment 7 Doses 298 Patients* 36 Sites: 2 sites ( 49 subjects) were excluded due to significant treatment by center interaction • 347 subjects received primary treatment and had baseline A 1 c (included in ITT) • 298 subjects included in primary analysis • 266 included in final analysis (Week 12 A 1 C results) *
18 Endpoints 01 02 Primary Endpoint ▪ Mean change in HbA 1 c from baseline to Week 12 Secondary Endpoints ▪ Safety (AEs, hypoglycemic) ▪ Fasting Plasma Glucose (FPG) + CGM ▪ Weight Dose Finding ▪ 96 mg/day ( 32 mg X 3 /day) ▪ 32 mg/day ( 32 mg X 1 /day) ▪ 32 mg/day ( 16 mg X 2 /day) ▪ 64 mg/day ( 32 mg X 2 /day) ▪ 16 mg/day ( 8 mg x 2 /day) ▪ 16 mg/day ( 16 mg X 1 /day) ▪ 8 mg/day ( 8 mg X 1 /day)
19 Phase 2b: Primary Endpoint Successfully Met - 0.81 - 0.82 0.25 - 0.36 - 0.54 - 0.53 - 0.45 -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0.4 8mg 8mgx2 16mg 16mgx2 32mg 32mgx2 32mgx3 HbA1c (%) Placebo Adjusted Change from Baseline 8 mg - 1 /day - 0.95 ( - 0.81 placebo adjusted) 60 - 70 % of the randomized patients were on 2 or more glucose lowering drugs All Patients were on Metformin Glucose lowering agents taken in addition to Metformin included: Glibenclamide , Glipizide, Empagliflozin, Pioglitazone, Glimepiride, Dapagliflozin, Sitagliptin, Glibomet , Ertugliflozin
20 Phase 2 b: 8 mg 1 /day – HbA 1 c Change from Baseline at Week 12 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 Placebo 8mg 8mg (Baseline >9%) 8 mg ( 1 xday) • 0.95 ( 0.81 placebo adjusted) reduction • p - value : 0.0276 • [ 1.29 A 1 C reduction (Observed Means)] • 1.26 placebo adjusted reduction (Baseline > 9 %)
21 FDA BLA Pathway: • Confirmatory Phase 3 Study • Submission to FDA x No increase in Adverse Events compared to Placebo x No increase in Hypoglycemic Events compared to Placebo x No weight gain compared to Placebo FDA Phase 2b Trial Results - Primary Endpoint Successfully Met Safe and well tolerated Significant HbA 1 c lowering with 1 X/daily treatment: Gain 12 - year marketing exclusivity upon FDA approval
Pivotal Phase 3 Factors considered by the FDA in a pivotal Phase 3 program 1. Efficacy : The study is powered, based on previous Phase 2 data, to include sufficient patients that will provide statistical significance for primary endpoint provided that the drug performs at least equally well in the Phase 3 study as it did in the Phase 2 study. 2. Safety : The study has sufficient patients, as determined by the FDA, to demonstrate that the drug is safe in diabetic patients. 3. Exposure : The study must show that the drug remains safe in patients exposed to the drug over a period of 6 and 12 months 4. Geographic variation : USA, Israel and EU countries 22
ORA - D - 013 - 1 A Double - Blinded, Placebo - Controlled, Double Dummy, Multi - Center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD - 0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose - Lowering Agents ORA - D - 013 - 2 A Double - Blinded, Placebo - Controlled, Multi - Center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD - 0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy 23 Pivotal Phase 3 : Two Protocols
Pivotal Phase 3 : Dosing (Selected from P 2 b study data) ▪ ORA - D - 013 - 01 - Double Blind, Double Dummy - 1:1:1 randomization ▪ 8 mg once - daily at night and placebo 45 mins before breakfast ▪ 8 mg twice - daily at night and 45 mins before breakfast ▪ Placebo twice - daily at night and 45 mins before breakfast ▪ ORA - D - 013 - 02 - Double Blind - 1:1 randomization ▪ 8 mg at night ▪ Placebo at night 24
25 Pivotal Phase 3 : Sample Size ORA - D - 013 - 2 ORA - D - 013 - 1 450 adult male and female subjects 675 adult male and female subjects Sample size US, Eastern and Western European and Israel - based US - based Territory 28 US sites, 25 ex - US sites 75 US sites Number of Sites
26 ORA - D - 013 - 1 : Primary and Secondary Objectives Primary Objective ▪ To compare the efficacy of ORMD - 0801 to placebo in improving glycemic control as assessed by A1c in inadequately controlled T2DM subjects on two or three oral glucose - lowering agents. Secondary Objective ▪ To assess the safety of repeat administration of ORMD - 0801 in inadequately controlled T 2 DM subjects on two or three oral glucose - lowering agents.
27 ORA - D - 013 - 2 : Primary and Secondary Objectives Primary Objectives ▪ Active vs Placebo: - To evaluate the efficacy of ORMD - 0801 compared to placebo in improving glycemic control as assessed by A 1 c in inadequately controlled T 2 DM subjects on diet control alone or on diet control and metformin monotherapy over a 26 - week treatment period. Secondary Objectives ▪ Active vs Placebo: - To evaluate the efficacy of ORMD - 0801 compared to placebo in maintaining glycemic control over a 52 - week treatment period.
28 Pivotal Phase 3 : Key Inclusion Criteria ORA - D - 013 - 1 ▪ HbA 1 c ≥ 7.5 % but ≤ 11.0 % at Screening. ▪ On a stable dose two or three of the following oral glucose - lowering agents for a 3 - month period prior to Screening: - Metformin - DPP - 4 inhibitor - SGLT - 2 inhibitor - Thiazolidinedione - Sulfonylurea ORA - D - 013 - 2 ▪ HbA1c ≥ 7.5% but ≤ 11.0% at Screening. ▪ Subjects should be on: - Diet and exercise alone for a period of at least 3 months prior to Screening; OR - Diet and exercise with a stable dose of metformin only (≥ 1500 mg or MTD) for a period of at least 3 months prior to Screening.
29 Prep BLA & File Pivotal Phase 3 : Anticipated Clinical Development Timelines 2018 2020 2021 2022 Phase 2b 3 - month A1C study T2D Phase 3 study T 2 D Phase 3 study EOP 2 prepare P 3 program Potential approval by 2024 CSR CSR 2023 2019 2024 CSR
30 China License Deal: 500 M patient potential * Journal of the American Medical Association ▪ License: Exclusive right to ORMD - 0801 in Greater China ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state - of - the - art GMP API insulin manufacturing facility - HTIT clinical trials of ORMD - 0801 underway ▪ $ 50 M Payments + Royalties: - $ 12 M in restricted stock (at premium) - $ 38 M milestone payments ▪ $ 33 M received to date ▪ $ 17 M expected over the next 2 - 3 years - Up to 10 % royalties on net sales diabetic ( 10.9 % of adult population) prediabetic ( 35.7% of adult population) Chinese diabetes market* 114 M ~ 388 M
31 Seagrove Partners completed focus groups with 94 total participants including HCPs, Patients & Payers in July 2020 . Project Background Key Findings Patient Segmentation Possible Positioning and SWOT Ancillary “ Base ” Package Ancillary “ Upside ” Package Commercial Positioning
NASH Study Leveraging Oral Insulin for Nonalcoholic Fatty Liver Disease 32 Nonalcoholic Steatohepatitis (NASH) ▪ Chronic liver disease caused by excessive fat in liver (MoA not fully known) ▪ Leads to fibrosis, cirrhosis and liver failure (death) ▪ 25 % of adults in the U.S. have NAFLD ▪ 5 % of adults in the U.S. have NASH ▪ 37 % among patients with T 2 DM Status ▪ Data from initial 8 patients presented at ADA 2020 : - Safety: ▪ 12 - week, once - daily treatment had no SAEs - Efficacy: ▪ 30% relative reduction measured by MRI - PDFF ▪ 6.9 “ 6.8% mean reduction in liver fat content (p value: 0.035) ▪ Initiation of 10 additional patients in EU (ongoing) ▪ Initiation of Double - Blind Placebo - Controlled Study (n=30) in US and Israel (Q4;2020)
ORMD - 0901: Oral GLP - 1 Analog
34 ▪ T 2 DM medication ▪ Mimics the natural hormone in the body ▪ Compelling safety profile ▪ Decreases blood glucose levels ▪ Effectively reduces HbA 1 c ▪ Preserves beta cell function ▪ Promotes weight loss ▪ IND ▪ Bioavailability study GLP - 1 Analog: ORMD - 0901 for Oral GLP - 1 (TD 2 M) GLP - 1 Analog ORMD - 0901 Clinical Status
35 Oral GLP - 1 - ORMD - 0901 Preserved the biological activity of orally delivered exenatide. ORMD - 0901 successfully curbed blood sugar excursions following glucose challenge ORMD - 0901 formulations Preclinical: Oral exenatide delivery amounted to a > 50 % reduction in mean glucose (similar to SC) 0 20 40 60 80 100 120 S.C. AG 4 AG 3 - + + + + Exenatide Glucose * * * Area (mg/dl)/minutes * 10 2 Human ( 4 healthy volunteers) 150 mg exenatide 0 50 100 150 -50 0 50 100 150 Insulin (mU/mL) n= 4 ORMD - 0901 Placebo
36 – Novel Oral Covid - 19 Company ▪ JV: - 63 % Oravax ’ s common stock - R ight to appoint the majority of BoD ▪ License: - Royalties: 7.5 % of net sales - Sublicensing: 15 % - S ales milestone : $ 25 M - $ 100 M ▪ Universal COVID vaccine ▪ Triple antigen vaccine expected to be effective against COVID variants ▪ Manufacturing advantages ▪ Ease of scale up ▪ Straight - forward tech transfer ▪ Manufacturing and COGs optimization ▪ Consistent process ▪ Safe, non - toxic, and efficacious in preclinical and GLP Tox studies in animals: ▪ No temperature rise, or body weight loss/gain, no adverse events noted in any animal ▪ Significant antibody response, as well as cellular immune response ▪ Showed desired immunological parameters and efficacy ▪ Long term retention of the antibody response in animals, post 150 days ▪ Oral format ▪ No needles ▪ Easy to administer at home (no need for professional administration) ▪ No need for low temperature storage (freezer) ▪ Potential for further reduction in side effects (greater safety)
37 Anticipated Development Milestones • Bioavailability Study (T 2 DM) Initiation & Completion • T 2 DM: Phase 3 trials • NASH: Phase 2 completion • Phase I ex - USA Initiation 0801 0901 Leptin 2021
38 Funneling Huge Injectable Drug Markets to Novel Oral Formulations Vaccines 2011: $2.9 b GLP - 1 2017: $6 b Insulin 2014 : $ 24 b NASH 2016: $138 m
39 Management Team Nadav Kidron, Esq, MBA - CEO & Director Many years of business experience as well as corporate law and technology Miriam Kidron, PhD - CSO & Director Senior Researcher at the Diabetes Unit of Hadassah Medical Center for more than 25 years Josh Hexter - Chief Operating & Business Officer More than 18 years of prominent leadership roles in biotech and pharma Avi Gabay, CPA - CFO Extensive experience in corporate financial management Roy Eldor, MD - Chief Medical Advisor Head of the Diabetes Unit at Tel - Aviv Sourasky Medical Center
40 Board of Directors Kevin Rakin - Chairman Co - Founder and Partner at HighCape Partners; former President of Regenerative Medicine at Shire plc Leonard Sank Entrepreneur and business leader; Director of Macsteel Service Centres SA (Pty) Ltd Aviad Friedman Director of public and private companies including Maayan Ventures, Capital Point and Rosetta Green Ltd. Arie Mayer Managing Director and Chairman of the Board of Merck Life Science Israel (formerly Sigma - Aldrich Israel Ltd.) Xiaoming Gao Chairman of HTIT, China Nadav Kidron CEO, Oramed Miriam Kidron CSO, Oramed
41 Scientific Advisory Board Roy Eldor, MD, PhD Director, Diabetes Unit, Institute of Endocrinology, Metabolism & Hypertension, Tel - Aviv Medical Center Ele Ferrannini, MD, PhD Professor, Internal Medicine, University of Pisa School of Medicine. Past President of the EASD Alexander Fleming, MD Recognized authority in the metabolic and endocrine fields with extensive FDA experience. Avram Herskho , MD, PhD; Nobel Laureate Distinguished professor in the biochemistry unit in the B. Rappaport Facility of Medicine, Technion, Haifa, Israel Harold Jacob, MD Chief Medical Officer, NanoVibronix . Previously, Director, Medical Affairs at Given Imaging. Julio Rosenstock, MD Director, Dallas Diabetes Research Center, Professor, University of Texas Southwestern Medical Center; Associate Editor, Diabetes Care . Jay Skyler, MD, MCAP Professor or Medicine, Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Miami.
42 Oramed (NASDAQ/TASE: ORMP) Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations ▪ Proprietary oral protein delivery platform ▪ Primary Indication: Insulin - initially targeting the lucrative insulin market; additional markets in the pipeline ▪ Strong financial position with over $56M in cash and investments, no debt, 28.3M shares outstanding (33.9M fully diluted) 1 ▪ Strong management team backed by world - class scientific experts ▪ Multiple near - term value - creation catalysts for this year ▪ Robust IP Portfolio - Methods and compositions for oral administration of proteins - Methods and compositions for oral administration of exenatide - Methods and compositions (insulin + exenatide) - Improved protease inhibitors 1 As of February 28 , 2021
THANK YOU www.oramed.com