EXHIBIT
10.1
CLINICAL TRIAL MANUFACTURING
AGREEMENT
|
This Clinical
Trial Manufacturing Agreement ( “Agreement” )
dated this
30th day of October,
2006 (the “Effective
Date” ) between:
|
|
|
SWISS CAPS AG
, of Husenstr. 35, CH-9533
Kirchberg, Switzerland ( “Swiss Caps” ) –
Fax +41 (0)71 931 41 91
And
ORAMED PHARMACEUTICALS,
INC. , of 2 Elza Street,
Jerusalem, 93706, Israel ( “Oramed” or the
“Company” ) –Fax +011
972-2-679-2336
WITNESSES THAT
WHEREAS
|
A.
|
Swiss Caps is
a manufacturer and business development services partner for the
pharmaceutical and healthcare industry;
|
|
|
|
B.
|
Oramed is in
the business of developing an oral form of insulin; and
|
|
|
|
C.
|
Oramed desires
to engage the services of Swiss Caps, and Swiss Caps accepts such
appointment, to manufacture and deliver the Product (as defined
below) to Oramed in accordance with the terms and conditions of
this Agreement.
|
|
|
NOW THEREFORE, in consideration
of the premises and the covenants and agreements set out herein,
the receipt and sufficiency of which is hereby acknowledged, the
parties agree as follows:
|
1.
|
DEFINITIONS &
INTERPRETATION
|
|
|
|
1.1
|
All
capitalised terms in this Agreement have the following
meaning:
|
|
|
|
|
(a)
|
“
Agreement ” means this agreement for services and
includes its schedules and any documents incorporated by reference,
as amended from time to time in accordance with its
terms.
|
|
|
|
|
(b)
|
“
Compensation ” means the compensation for the Services
as set out in the Statement of Work.
|
|
|
|
|
(c)
|
“
Force Majeure Event ” means any act of God or act of
nature, fire, flood, storm, explosion, sabotage, riot, act of war
whether declared or not, act of terrorism, requirement or
restriction of governmental authorities, inability or delay in the
grant of governmental or other approvals, consents, permits,
licenses or authorities or any other like event, any strike,
lockout, work stoppage or other industrial dispute of any kind, or
any other event or circumstance beyond the reasonable control of
the affected party.
|
|
|
CW638406.16
- 2 -
|
(d)
|
“
Intellectual Property ” means all inventions, methods,
processes, ideas and concepts, whether patentable or not, all
literary and other works and all data and databases, whether or not
protected by copyright, all trade-marks, trade names and domain
names, industrial designs, integrated circuit topographies, trade
secrets, know-how and show-how.
|
|
|
|
(e)
|
“
Intellectual Property Rights ” means all world-wide
legal protection provided for Intellectual Property, whether under
statute, common law, international treaty or in equity, including
all protection granted under laws protecting patent, copyright,
trade-mark, industrial design, trade secret or integrated circuit
topography rights.
|
|
|
|
(f)
|
“
Loss ” means all costs, loss, damage, liability or
expenses (including all reasonable legal costs, fees and
expenses).
|
|
|
|
(g)
|
“
Oramed Confidential Information ” means all
confidential information of Oramed including all Oramed Materials,
all know-how, trade secrets, business ideas and concepts of Oramed,
all technical, operational, strategic, marketing, financial and
business information relating to Oramed, all Intellectual Property
of Oramed and any formulas, reports, notes, medical records, test
results, patient information and any other information or data
provided to Swiss Caps by Oramed that is designated in writing as
confidential or that Swiss Caps ought to be reasonably aware is
confidential. Oramed Confidential Information does not include
information which is: (i) made public other than by a breach of an
obligation of confidentiality, (ii) disclosed to Swiss Caps free of
any obligation to keep it confidential, or (iii) independently
developed by Swiss Caps without use, directly or indirectly, of
Oramed Confidential Information received from Oramed.
|
|
|
|
(h)
|
“
Oramed Materials ” means all materials provided by
Oramed to Swiss Caps in order to assist Swiss Caps with the
provision of the Services including, without limitation, those
listed on Schedule 1 attached to this Agreement.
|
|
|
|
(i)
|
“
Personnel ” means directors, officers, employees,
agents, contractors, advisers or representatives of a
party.
|
|
|
|
(j)
|
“
Primary Contact ” has the meaning given to that term
in Section 4.1 of this Agreement.
|
|
|
|
(k)
|
“
Product ” means the product developed as a result of
the provision of the Services in accordance with the
Specifications, as detailed in the Statement of Work.
|
|
|
|
(l)
|
“
Representatives ” has the meaning given to that term
in Section 15.4(b) of this Agreement.
|
|
|
|
(m)
|
“
Services ” means the services which Swiss Caps has
agreed to supply to Oramed as detailed in the Statement of
Work.
|
|
|
CW638406.16
- 3 -
|
(n)
|
“
Specifications ” means the technical specifications
for the Product, as specified in the Statement of Work.
|
|
|
|
(o)
|
“
Swiss Caps Confidential Information ” means all
confidential information of Swiss Caps including all know-how,
trade secrets, business ideas and concepts of Swiss Caps, all
technical, operational, strategic, marketing, financial and
business information relating to Swiss Caps, all Intellectual
Property of Swiss Caps and any other information or data provided
to Oramed by Swiss Caps that is designated in writing as
confidential or that Oramed ought to be reasonably aware is
confidential. Swiss Caps Confidential Information does not include
information which is: (i) made public other than by a breach of an
obligation of confidentiality, (ii) disclosed to Oramed free of any
obligation to keep it confidential, or (iii) independently
developed by Oramed without use, directly or indirectly, of Swiss
Caps Confidential Information received from Swiss Caps.
|
|
|
|
(p)
|
“
Statement of Work ” means the statement of work
attached as Schedule 1 to this Agreement, setting out the Services,
the Product, the Specifications and the Compensation, as amended by
the parties from time-to-time in accordance with the terms of this
Agreement.
|
|
|
|
(q)
|
“
Term ” has the meaning given to that term in Section
3.1 of this Agreement.
|
|
|
|
1.2
|
All references
to any Section herein is to the Section in this Agreement unless
otherwise specified. All references to a Schedule herein is to a
Schedule of this Agreement unless otherwise specified.
|
|
|
|
1.3
|
The headings
in this Agreement are for reference purposes only and will not be
deemed a part of the Agreement.
|
|
|
|
1.4
|
The term
“including” means including without limitation or
prejudice to the generality of any description, definition, term or
phrase preceding that word, and the word “include” and
its derivatives will be construed accordingly.
|
|
|
|
1.5
|
The
interpretation of any ambiguities will be construed by the
principles of fairness and reasonable business practice, and
authorship of this Agreement will have no bearing on the
construction of any terms hereof.
|
|
|
|
2.
|
APPOINTMENT
|
|
|
|
2.1
|
Swiss Caps
hereby agrees to perform for Oramed and Oramed hereby engages Swiss
Caps to perform the Services in accordance with the terms and
conditions of this Agreement.
|
|
|
|
2.2
|
The parties
agree and acknowledge that:
|
|
|
|
|
(a)
|
the
manufacturing of the Product under this Agreement is for clinical
testing purposes (proof of concept) only; and
|
|
|
CW638406.16
- 4 -
|
(b)
|
should Oramed
elect to engage Swiss Caps to manufacture the Product for
commercial distribution, a separate agreement will be entered into
by the parties for such purpose.
|
|
|
|
3.
|
TERM
|
|
|
|
3.1
|
Subject to the
express termination rights granted herein, this Agreement will
commence on the Effective Date and will remain in full force and
effect for a period of six (6) months from the Effective Date (the
“ Term ”). The parties may renew this Agreement
by mutual consent.
|
|
|
|
4.
|
PRIMARY
CONTACTS
|
|
|
|
4.1
|
Upon execution
of this Agreement, each party will designate a primary contact
(“ Primary Contact ”) who will have the primary
responsibility for that party’s relationship with the other
party and will have the authority necessary to make the day-to- day
decisions on behalf of that party with respect to the
implementation of this Agreement.
|
|
|
|
5.
|
SERVICES
|
|
|
|
5.1
|
Swiss Caps
will perform the Services in accordance with the terms of this
Agreement and otherwise in a professional and workmanlike manner in
accordance with industry best practices and using only
appropriately skilled and experienced personnel exercising due care
at all times.
|
|
|
|
5.2
|
Swiss Caps
will commence performing the Services on the Effective Date and
will use best commercial efforts to meet the milestones and target
dates (if any) specified in the Statement of Work.
|
|
|
|
5.3
|
Oramed will,
promptly after the Effective Date, deliver to Swiss Caps the Oramed
Materials necessary for Swiss Caps to fulfil its obligations
herein.
|
|
|
|
5.4
|
Oramed will
ship the Oramed Materials to Swiss Caps Delivered Duty Paid (DDP)
(Incoterms 2000), and Swiss Caps will be responsible for insuring
against loss or damage while the Oramed Materials are in the
custody, possession or control of Swiss Caps, as required by
Section 13.
|
|
|
|
5.5
|
Notwithstanding the above clause, Swiss Caps is
responsible to provide, at its cost, all materials necessary to
carry out the terms of this Agreement and provide the Services and
the Product.
|
|
|
|
5.6
|
Swiss Caps
will ship the Product, FCA Kirchberg (Incoterms 2000), to
Oramed’s nominated address promptly on completion of the
Services.
|
|
|
CW638406.16
- 5 -
|
6.
|
AMENDMENT TO STATEMENT OF
WORK
|
|
|
|
6.1
|
If the parties
jointly determine that the scope of the Services being provided
under the Statement of Work, or the assumptions on which those
Services are based, has changed during the course of the
engagement, then such changes will be described in a written change
order (“ Change Order ”) to be signed by both
parties. At the option of Oramed, such additional Services may be
addressed in a separate Statement of Work signed by both
parties.
|
|
|
|
6.2
|
If Oramed
wishes at any time to request a change in the Services specified in
the Statement of Work, then it will prepare a Change Order. Swiss
Caps will evaluate and respond to any change request within 20
business days or such other period as the parties may agree in
writing. Swiss Caps’ response will include the amount of any
adjustment to the Compensation, if any, and an estimate on any
perceived changes to the delivery dates, if applicable, specified
for the Product in light of the change to the scope of the
Services.
|
|
|
|
|
Upon receiving
written authorization from Oramed, Swiss Caps will proceed with
Oramed’s requested changes and the Statement of Work will be
deemed to be amended accordingly.
|
|
|
|
7.
|
ORAMED
WARRANTIES
|
|
|
|
7.1
|
Oramed
represents and warrants that:
|
|
|
|
|
(a)
|
it is
authorized to enter into this Agreement and be bound by its
terms;
|
|
|
|
|
(b)
|
it is not
bound by the terms of any agreement which would limit, restrict or
conflict with its obligations herein; and
|
|
|
|
|
(c)
|
it possesses
all relevant permissions, consents, authorities and licenses to
perform its obligations set out in this Agreement.
|
|
|
|
8.
|
SWISS
CAPS WARRANTIES
|
|
|
|
8.1
|
Swiss Caps
represents and warrants that:
|
|
|
|
|
(a)
|
it is
authorized to enter into this Agreement and be bound by its
terms;
|
|
|
|
|
(b)
|
it is not
bound by the terms of any agreement which would limit, restrict or
conflict with its obligations herein;
|
|
|
|
|
(c)
|
it possesses
all relevant permissions, consents, authorities and licenses to
perform its obligations set out in this Agreement;
|
|
|
|
|
(d)
|
it will
perform its obligations under this Agreement in compliance with all
applicable laws, statutes, regulations and codes of
conduct;
|
|
|
|
|
(e)
|
its method of
manufacturing the Product will not infringe the Intellectual
Property Rights of any third party; and
|
|
|
CW638406.16
- 6 -
(f) the Product delivered to
Oramed will conform with the Specifications.
|
9.
|
COMPENSATION
|
|
|
|
9.1
|
The amount of
the Compensation is set out in the Statement of Work.
|
|
|
|
9.2
|
Subject to
Section 9.3, Oramed will pay the Compensation to Swiss Caps in 2
instalment payments in the amounts set out in the Statement of
Work. Swiss Caps will deliver an invoice to Oramed for each
instalment payment as follows:
|
|
|
|
|
(a)
|
the first such
invoice will be delivered to Oramed on or after the date that Swiss
Caps confirms in writing to Oramed that it has commenced
performance of the Services; and
|
|
|
|
|
(b)
|
the second
such invoice will be delivered to Oramed on or after the date that
Oramed advises Swiss Caps in writing that it has received the
Product from Oramed.
|
|
|
|
9.3
|
In full
satisfaction of its obligation to pay each instalment payment of
the Compensation to Swiss Caps, Oramed will issue that number of
common shares in its capital stock having an aggregate value equal
to the amount of that instalment payment. For the purposes of
determining the number of common shares to be issued to Swiss Caps
pursuant to an instalment payment, the Oramed common shares will be
valued at the current trading price of such shares on the U.S. Over
the Counter Bulletin Board on the 10th trading day after the
invoice in respect of that instalment payment is delivered to
Oramed in accordance with Section 9.2. Oramed will issue the
applicable number of common shares to Swiss Caps within 30 days
after receipt of such invoice.
|
|
|
|
9.4
|
Swiss Caps agrees and
acknowledges that Oramed’s obligation to pay the Compensation
is subject to Oramed’s determination that: (a) the quantity
of Product delivered to Oramed meets the requirements set forth in
the Statement of Work; and (b) the Product delivered to Oramed is
free from visible defects or damage. Within 5 business days after
receipt of the Product, Oramed will either: (c) deliver written
notice to Swiss Caps that Oramed accepts the Product as delivered;
or (d) deliver written notice to Swiss Caps stating, as applicable:
(i) that there is a discrepancy between the number of Product
actually delivered and the number of Product specified in the
Statement of Work; and/or (ii) that there are visible defects or damage to the
Product, and specifying such defect or damage in reasonable detail. If Oramed fails
to deliver a notice under (c) or (d) above in this Section with
such 5 business day period, then it will be deemed to have accepted
the Product for the purposes of this Section 9.
|
|
|
|
|
|
|
|
|
|
|
|
9.5
|
Swiss Caps
acknowledges that it is receiving the Compensation outside of the
United States and warrants, represents and acknowledges the
statements and covenants set out in Schedule 2 attached to this
Agreement.
|
|
|
CW638406.16
- 7 -
|
10.
|
TERMINATION
|
|
|
|
10.1
|
Either party
may terminate this Agreement (in whole or in part) at any time with
immediate effect by giving written notice to the other party (the
“ Defaulting Party ”), if:
|
|
|
|
|
(a)
|
the Defaulting
Party materially breaches any provision of this Agreement that: (i)
is not capable of being remedied; or (ii) is capable of being
remedied but is not remedied within 15 days after receiving notice
from the non-Defaulting Party requiring it to do so;
|
|
|
|
|
(b)
|
a Force
Majeure Event substantially adversely affects the ability of the
Defaulting Party to perform its obligations under this Agreement
continuously for a period of not less than 15 days;
|
|
|
|
|
(c)
|
any proceeding
in bankruptcy, receivership, liquidation or insolvency is commenced
against the Defaulting Party or its property and is not dismissed
within 30 days; or
|
|
|
|
|
(d)
|
the Defaulting
Party makes any assignment for the benefit of creditors, becomes
insolvent, commits any act of bankruptcy, ceases to do business as
a going concern, seeks any arrangement or compromise with its
creditors under any statute or otherwise, or is unable to pay its
debts as and when they fall due.
|
|
|
|
10.2
|
Except as
provided in Section 10.1, Swiss Caps will have no right to
terminate this Agreement (in whole or in part) during the
Term.
|
|
|
|
11.
|
CONSEQUENCES OF TERMINATION
|
|
|
|
11.1
|
Within 14 days
of the expiry of the Term or earlier termination of this Agreement
or any part thereof:
|
|
|
|
|
(a)
|
Swiss Caps
will immediately return to Oramed all Oramed Materials and Oramed
Confidential Information which is in the possession, custody or
control of Swiss Caps;
|
|
|
|
|
(b)
|
Oramed will
immediately return to Swiss Caps all Swiss Caps Confidential
Information which is in the possession, custody or control of
Oramed; and
|
|
|
|
|
(c)
|
the parties
will use best commercial efforts to co-operate fully with each
other in effecting an orderly transition of the Services, if
applicable.
|
|
|
|
11.2
|
The exercise
by Oramed of its right to terminate this Agreement (in whole or in
part) under Section 10 will not affect or impair Oramed’s
other rights or remedies under this Agreement or otherwise at law
or in equity.
|
|
|
CW638406.16
- 8 -
|
12.
|
SWISS
CAPS INDEMNITY
|
|
|
|
12.1
|
Notwithstanding any other term in this
Agreement, Swiss Caps hereby covenants and agrees to indemnify and
hold Oramed harmless from and against:
|
|
|
|
|
(a)
|
all Loss
arising from or relating to personal injury or death to the extent
that such Loss is caused by a negligent or wilful act or omission
or breach of this Agreement by Swiss Caps or any of its
Personnel;
|
|
|
|
|
(b)
|
all Loss
arising from any breach or failure of performance by Swiss Caps of
any of its warranties, covenants or material obligations in this
Agreement;
|
|
|
|
|
(c)
|
any damage to
or loss of any tangible property of Or
|
|