UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
_____________________
FORM
8-K
_____________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of the
Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): January 7, 2009
_____________________
ORAMED
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
|
Nevada
(State
or other jurisdiction
of
incorporation)
|
000-50298
(Commission
File Number)
|
98-0376008
(IRS
Employer
Identification
No.)
|
Hi-Tech
Park 2/5 Givat Ram
PO
Box 39098
Jerusalem,
Israel 91390
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: 972-2-566-0001
_____________________
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
[
] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[
] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
|
ITEM
1.01
|
ENTRY
INTO A MATERIAL DEFINITIVE
AGREEMENT.
|
On
February 17, 2006, Oramed Pharmaceuticals, Inc. (the “Company”) under its former
name, Integrated Security Technologies, Inc.) entered into an Agreement (the
“First Agreement”) with Hadasit Medical Research Services and Development Ltd.
(“Hadasit”), which was disclosed on a Form 8-K filed on February 17, 2006. Among
other things, the First Agreement provided that Hadasit would sell certain
patents (the “Acquired Patents”) to the Company. In connection
with such acquisition, the Company agreed to enter into clinical
trials of the Acquired Patents and to arrange financing for the
Company. The First Agreement contemplated a “closing” conditioned
upon completion of the clinical trials.
On
January 7, 2009, the Company entered into an agreement with Hadasit (the
“Agreement”) to provide for the closing referenced in the First
Agreement.
In this
Agreement, Hadasit confirms that it has conveyed, transferred and assigned all
of its ownership rights in the Acquired Patents and certain other patents filed
by the Company after the First Agreement as a result of the collaboration
between the Company and Hadasit (the “Additional Patents”). Hadasit
further acknowledges that the 4,141,532 shares of common stock issued to Hadasit
by the Company in connection with the First Agreement constitute complete
compensation for the Acquired Patents and the Additional Patents.
The
parties agreed that the Company shall control all prosecution, defense,
enforcement and maintenance of the patents and bear all related
costs. The Agreement provides that should the Company not incur such
costs for any reason, then the Acquired Patents and Additional Patents shall be
deemed to be assigned back to Hadasit. Further, the Agreement
provides that if it is discovered that Dr. Miriam Kidron is not the sole
inventor of the Acquired Patents and the Additional Patents and any of them are
subject to a claim by an employee of Hadassah Medical Organization, any payments
that must be paid in connection with such discovery will be paid solely by Dr.
Kidron, and such payment may be made in shares of the Company. The
Agreement will remain in effect until the expiration of the last to expire of
the Acquired Patents and the Additional Patents.
The
Company agrees to indemnify Hadasit, Hadassah Medical Organization and their
respective affiliates against losses arising out of the production,
manufacture, sale, use, lease or promotion of any product process or service
relating to or developed based on the Acquired Patents or the Additional
Patents.
The
Agreement is being furnished as Exhibit 10.1 to this Current Report on Form 8-K
and is incorporated herein by reference. The description of the Agreement is
qualified in its entirety by reference to such document.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
|
Exhibits
|
|
10.1
|
Agreement,
dated January 7, 2009, by and between Oramed Pharmaceuticals, Inc. and
Hadasit Medical Research Services and Development
Ltd.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
ORAMED PHARMACEUTICALS
INC.
|
||
|
Dated:
January 7, 2009
|
||
|
By:
|
/s/
Nadav Kidron
|
|
|
Nadav
Kidron
|
||
|
President,
CEO and
Director
|
||
AGREEMENT
This
Agreement (the “Agreement”) is effective as of
this 7th day of January, 2008 (the “Effective Date”) by and
between, Oramed Pharmaceuticals Inc., a company established under the laws of
the state of Navada with offices at 2/5 High Tech Park, Givat Ram Jerusalem,
Israel (“OraMed”), and
Hadasit Medical Research Services and Development Ltd. an Israeli Company with
offices at P.O.B 12000, Jerusalem, 91120 Israel (the “Hadasit”).
Whereas, OraMed is the
successor of Integrated Security Technologies, Inc. ("IST"); and
Whereas, Hadasit and IST
entered on February 1, 2006 into the agreement regarding Method of Replacing
Insulin Injections with Oral Insulin attached hereto as Exhibit A (the "First Agreement");
and
Whereas, the First Agreement
contains certain terms and conditions all of which have been met by OraMed,
including, the Financing defined in Section 7 of the First Agreement which has
been raised by OraMed, the Clinical Trials defined in Section 5 of the First
Agreement which have been successfully completed and the closing conditions in
section 13 and 14 of the First Agreement which have been met; and
Whereas, the parties now wish
to perform the Closing (as defined in the First Agreement) and replace the First
Agreement with the terms and conditions set forth herein;
Now
therefore, the parties hereto agree as follows:
|
1.
|
DEFINITIONS. In addition
to terms elsewhere defined in this Agreement, the following terms shall
have the meanings set forth opposite each one of
them:
|
|
1.1.
|
"Acquired Patents" means
the Patents set forth on Exhibit B
and all subject matters disclosed and claimed
therein.
|
|
1.2.
|
"Additional Patents"
means all Patents filed by OraMed as a result of the collaboration with
Hadasit as listed in Exhibit C and
all subject matters disclosed and claimed
therein
|
|
1.3.
|
Patents" means
(i) all patents and patent applications and any patents issuing
therefrom worldwide, (ii) any patents and patent applications claiming
priority form (i) above, (iii) any substitutions, divisions,
continuations, continuations-in-part, reissues, renewals, registrations,
confirmations, re-examinations, extensions, supplementary protection
certificates, term extensions (under patent or other law), certificates of
invention and the like, of any such patents or patent applications,
(iv) any foreign or international equivalent of any of the foregoing;
and (v) any application claiming priority of any patent in (i)-(iv)
above.
|
|
2.
|
ASSIGNMENT
OF PATENTS
|
|
2.1.
|
Consideration.
Hadasit acknowledges and agrees that the 4,141,532 common stock par value
US$0.001 of OraMed issued to Hadasit on February 17, 2006 constitute the
sole and complete compensation and consideration for the sale, transfer
and assignment of the Acquired Patents and Additional Patents and that
Hadasit is not and will not be entitled for any additional consideration
of any kind for the sale, transfer and assignment of the Acquired Patents
and the Additional Patents.
|
|
2.2.
|
Acquired
Patents. Hadasit confirms that it has conveyed, transferred and
assigned all if its ownership rights in the Acquired Patents and any other
rights, title and interest in and to the Acquired Patents to OraMed and
that Hadasit has no and will have no claims whatsoever regarding the
Acquired Patents. Hadasit further confirms and acknowledge that OraMed has
had the right to file the Acquired Patents in its own
name.
|
|
2.3.
|
Additional
Patents. Hadasit further confirms its ownership rights and any
other rights, title and interest in and to the Additional Patents have
been or will be assigned, conveyed and transferred to OraMed exclusively
immediately upon OraMed's requests and that Hadasit has no and will have
no claims whatsoever regarding these Additional
Patents.
|
|
2.4.
|
For
the avoidance of doubt, Hadasit acknowledges and confirms that it has
neither claims of any kind nor any rights to any of the Additional Patents
listed in Exhibit C, attached hereto, all of which were filed by OraMed
after the First Agreement. OraMed will exclusively control all
prosecution, defense, enforcement, maintenance and will fully incur all
costs of maintenance of both the Acquired Patents and the Additional
Patents. Should OraMed decides for any reason not to incur some of the
Patent costs and expenses (including, but not limited to, defense thereof
against third parties claims or prosecution of third parties infringing
same) relating to the Acquired Patents, and Hadasit shall bear such
expenses in its stead, then OraMed shall be deemed to have automatically
waived and assigned all its rights under the Acquired Patents or the
Additional Patents, and shall not be entitled to any remuneration or
compensation in respect of such rights or such assignment derived from
Hadasit incurring such expenses. OraMed shall then take all steps and/or
execute all documents necessary in order to give full force and effect to
any such agreement to assign the Acquired or Additional Patents to
Hadasit.
|
-2-
|
2.5.
|
In
the event that Dr. Miriam Kidron is subsequently discovered not to be the
sole inventor of the Acquired Patents or the Additional Patents and that
either of them is subject to a claim by any current or former employee of
Hadassah Medical Organization ("Hadasit Inventor"), any consideration that
may be required to be paid to any Hadasit Inventor pursuant the Hadasit's
internal guidelines or otherwise will be payable to such Hadasit Inventor
solely by Dr. Miriam Kidron. In no event, including the event described in
this subsection, shall the consideration paid to Hadasit be reduced and/or
altered in any manner in order to compensate the Hadasit Inventor. Any and
all Hadasit Inventor shall assign and will assign and transfer their
entire right, title, and interest exclusively to Oramed, subject to the
Hadasit Inventor’s entitlement to a proportionate share of Dr. Miriam
Kidron share holdings in OraMed.
|
|
2.6.
|
Representations and
Warranties. Hadasit hereby represents and warrants
that:
|
|
|
2.6.1.
|
It
has as of the Effective Date, and will have during the Term, sufficient
rights and power to grant the rights to OraMed to which it purports to
grant herein, free and clear of any and all liens and any requirements of
charges, fees, rights, conditions or restrictions of any kind;
and
|
|
|
2.6.2.
|
It
has not granted any third parties any rights or licenses in the Acquired
Patents and Additional Patents.
|
|
|
2.6.3.
|
From
November 1, 2006, Dr. Miriam Kidron is no longer an employee of Hadassa
Medical Organization or Hadasit, and no employer-employee relationship
exists as of that date between Hadassah Medical Organization or Hadasit
and Dr. Miriam Kidron. Furthermore, from November 1, 2006 any results
developed by Dr. Miriam Kidron using her funds, do not belong to Hadassah
Medical Organization or to Hadasit.
|
|
|
2.6.4.
|
it
will execute any further document reasonably requested by OraMed in order
to effect this Agreement and the assignment of rights
herein.
|
|
|
2.6.5.
|
this
Agreement is a legal and valid obligation binding upon it and enforceable
in accordance with its terms; and
|
|
|
2.6.6.
|
the
execution, delivery and performance of this Agreement do not conflict with
any agreement, instrument or understanding, oral or written, to which it
is a party or by which it may be bound, nor violate any law or regulation
of any court, governmental body or administrative or other agency having
jurisdiction over it.
|
|
2.7.
|
Disclaimer.
Except as expressly set forth herein, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND
EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE,
NON-INFRINGEMENT, MERCHANTIBILITY AND FITNESS FOR A PARTICULAR
PURPOSE.
|
|
3.
|
CLINICAL
TRIALS
|
|
3.1.
|
Clinical Trial.
Hadasit further acknowledges and agrees that all the results of Clinical
Trials including currently performed clinical trials concerning the
intellectual property and technology which is the subject matter of this
Agreement, including all intellectual property right thereof, data,
information, records, notes forms and regulatory files belong exclusively
to OraMed.
|
-3-
|
3.2.
|
Dr. Miriam
Kidron. Dr. Kidron has retired and is not longer an employee of
Hadsit or Hadassah Medical Organization. OraMed has no outstanding
obligations for Hadasit with respect to Dr. Kidron and Hadasit has no
claims for her as they relate to the First Agreement, the Acquired Patents
and/or the Additional Patents, subject to sub-clause 2.5
above.
|
|
4.
|
TERM
|
|
4.1.
|
This
Agreement shall become effective on the Effective Date and shall continue
until the last to expire of the Acquired Patents and the Additional
Patents (the "Term").
|
|
5.
|
MISCELLANEOUS.
|
|
5.1.
|
Governing Law.
This Agreement shall be governed by and construed according to the laws of
the State of Israel without regard to the conflict of laws provisions
thereof. Any dispute arising under or in relation to this
Agreement shall be resolved in the competent courts of Tel Aviv-Jaffa
District, and each of the parties hereby submits irrevocably to the
jurisdiction of such court.
|
|
5.2.
|
Assignment.
Hadasit may not assign any of its rights or delegate any of its
obligations under this Agreement by operation of law or otherwise without
the prior written consent of OraMed. OraMed shall be free to
assign this Agreement in its sole discretion to its affiliates or to an
entity that acquires a majority of the assets of OraMed to which this
Agreement relates or all or substantially all of the equity of OraMed,
provided that any such Assignee fully undertakes OraMed’s obligations
under this Agreement. Any attempted assignment in violation of the
foregoing shall be null and void and of no effect. Subject to the
foregoing, this Agreement shall bind and inure to the benefit of the
Parties and their successors and
assigns.
|
|
5.3.
|
Headings. The
heading and captions are for convenience only and do not form part of this
Agreement and are not intended to interpret, define or limit the scope,
extent or intent of this Agreement or any provisions
hereof.
|
|
5.4.
|
Exhibits. The
exhibits of this Agreement form an integral part of this Agreement and
they may be changed and updated by agreement in writing of both Parties
hereto from time to time.
|
|
5.5.
|
Notices. Notices
to either Party to this Agreement shall be deemed given (a) four business
days after being mailed by airmail, postage prepaid, (b) the same business
day, if dispatched by facsimile and sender receives acknowledgment of
receipt. Mail shall be addressed as first set forth above, or
to either Party at such other address as it shall have notified the other
pursuant to the provisions of this subsection 5.5.
|
|
5.6.
|
Entire
Agreement. This Agreement constitutes the entire
agreement between OraMed and Hadasit with respect to the subject matter
hereof superseding any prior agreement, including, the First Agreement,
which is hereby no longer valid and shall be null and void. In
the event of a contradiction between the body of this Agreement and any
one of the exhibits thereto, the provisions contained in this Agreement
shall prevail.
|
|
5.7.
|
Amendment. This
Agreement may not be altered, amended or modified, except by formal
agreement in writing signed by duly authorized representatives of both
Parties.
|
|
5.8.
|
Independent
Contractors. The Parties hereto are and shall remain
independent contractors. Nothing herein shall be deemed to establish a
partnership, joint venture, or agency relationship between the Parties.
Neither Party shall have the right to obligate or bind the other Party in
any manner to any third party.
|
|
5.9.
|
No
Waiver. Neither Party shall, by mere lapse of time,
without giving notice thereof, be deemed to have waived any breach by the
other Party of any terms or provisions of this Agreement. The
waiver by either Party of any such breach shall not be construed as a
waiver of subsequent breaches or as a continuing waiver of such
breach.
|
|
5.10.
|
Severability. In
the event that any provision contained in his Agreement should, for any
reason, be held to be invalid or unenforceable in any respect under the
laws of any jurisdiction where enforcement is sought, such invalidity or
unenforceability shall not affect any other provision of this Agreement
and this Agreement shall be construed as if such invalid or unenforceable
provision had not been contained
herein.
|
-4-
|
5.11.
|
Counterparts.
This Agreement may be executed in one or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute
one and the same instrument.
|
|
5.12.
|
Indemnification:
Oramed shall indemnify, defend and hold harmless Hadasit, Hadassah Medical
Organization, their trustees, officers, directors, medical and
professional staff, employees, students and agents and their respective
successors, heirs and assigns (the "Indemnitees"), against any liability,
damage, loss or expense (including reasonable attorneys' fees and expenses
of litigation) incurred by or imposed upon the Indemnitees or any one of
them in connection with any claims, suits, actions, demands or judgments
arising out of the production, manufacture, sale, use in commerce or in
human clinical trials, lease, or promotion by OraMed or by a licensee,
affiliate or agent of OraMed of any product, process or service relating
to, or developed based on the Acquired Patents or the Additional Patents,
or arising out of the performance of any related Clinical Trials. Oramed's
indemnification obligation above will not apply to any liability, damage,
loss or expense to the extent that it is attributable to the negligence,
gross negligence, intentional misconduct or breach of any applicable laws
by any of the Indemnitees.
|
|
5.13.
|
Notwithstanding
anything to the contrary herein, OraMed shall not use the names of the
Hadasit, “Hadassah” or “HMO” without Hadasit’s prior written approval, not
to be unreasonably withheld, all except for (a) references to scientific
publications which are already in the public domain at the time of
publication and (b) applications for regulatory approvals to official
authorities, and (c) as requested by regulatory authorities as required by
law or applicable regulation. Notwithstanding the foregoing, OraMed shall
include appropriate acknowledgement and credit to Hadasit, HMO, and their
employees in any publication relating to the Clinical Trials and/or the
Patents, in whatever media, including application(s) to official
authorities or presentations to potential investors. Hadasit acknowledges
that OraMed is a reporting issuer in the United States and as such must
file a copy of this Agreement with the SEC, which will be open for
inspection by any party over the internet. Additionally, OraMed will be
required to make full disclosure in material change report and in its
periodic reports and other regulatory filing all aspects of this
transaction. Hadasit hereby consents to all such
filings.
|
IN WITNESS WHEREOF, the
Parties hereto have caused this Agreement to be executed by their respective
duly authorized representatives as of the Effective Date.
|
HADASIT
|
ORAMED
INC.
|
|||
|
By:
|
/s/
Raphael Hofstein
|
By:
|
/s/
Nadav Kidron
|
|
|
Name:
|
Raphael
Hofstein
|
Name:
|
Nadav
Kidron
|
|
|
Title:
|
President
& CEO
|
Title:
|
CEO
|
|