UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of the
Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): July 14, 2010
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):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o 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 July
5, 2010, Oramed Ltd., a subsidiary of Oramed Pharmaceuticals Inc., entered into
a Manufacturing Supply Agreement (MSA) with SANOFI-AVENTIS DEUTSCHLAND GMBH
("sanofi-aventis"). According to the MSA, sanofi-aventis will supply the
subsidiary with specified quantities of recombinant human insulin to be used by
Oramed for its clinical trials in the USA.
The
foregoing description of the Manufacturing Supply Agreement does not purport to
be complete and is qualified in its entirety by reference to the actual
transaction document, which is attached to this Current Report on Form 8-K as
Exhibit 10.1.
|
ITEM
7.01
|
REGULATION
FD DISCLOSURE
|
On July
7, 2010, Oramed Pharmaceuticals Inc. issued a press release announcing the
transaction described in Item 1.01. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated
by reference herein.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
|
Exhibits
|
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated July 7, 2010.
|
|
|
10.1
|
Manufacturing
Supply Agreement dated July 5, 2010, between Oramed Ltd. and
Sanofi-Aventis Deutschland GMBH
|
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:
July 14, 2010
|
|||
|
By:
|
/s/
Nadav Kidron
|
||
|
Nadav
Kidron
|
|||
|
President,
CEO and
Director
|
|||
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated July 7, 2010.
|
|
|
10.1
|
Manufacturing
Supply Agreement dated July 5, 2010, between Oramed Ltd. and
Sanofi-Aventis Deutschland GMBH
|
ACTIVE PHARMACEUTICAL
INGREDIENT
MANUFACTURING AND CLINICAL
SUPPLY AGREEMENT
(RECOMBINANT
HUMAN INSULIN)
THIS MANUFACTURING AND SUPPLY
AGREEMENT (this “Agreement”) is
entered into as of July 5, 2010 (the “Effective Date”)
ORAMED LTD., a company organized
under the laws of the State of Israel with principal offices at Hi-Tech Park 2/5
Givat-Ram, PO Box 39098, Jerusalem 91390, Israel (“Buyer”) and SANOFI-AVENTIS DEUTSCHLAND
GMBH, a
company existing under the laws of Germany, located at Industriepark Hoechst,
65926 Frankfurt am Main, Germany (“SAD”).
Buyer and
SAD are individually referred to herein as a “Party” and are
collectively referred to herein as the “Parties”.
Background
A. Buyer
wishes to engage SAD to perform services for Buyer, as more specifically set
forth herein, in connection with the manufacturing and supply of Active
Ingredient (as defined below) for use in clinical trials of the Product (as
defined below).
B. SAD
wishes to perform such services, all on the terms and conditions set forth in
this Agreement.
Covenants
In consideration of the mutual
covenants and promises set forth herein, and intending to be legally bound
hereby, the Parties agree as follows:
ARTICLE
1
DEFINITIONS
The following terms, whether used in
the singular or plural, shall have the meanings assigned to them below for
purposes of this Agreement
“Acquisition Cost”
shall mean the actual invoiced price actually paid by SAD to any Third Party for
materials, components and packaging materials required to manufacture and
package the Active Ingredient hereunder, including, but not limited to, shipping
and handling costs, taxes and customs duties incurred and paid by SAD to any
Third Party in connection with the acquisition of such materials and components,
as the case may be.
“Active Ingredient”
shall mean Recombinant Human Insulin as manufactured by SAD in accordance with
the Active Ingredient Specifications, for use in the Product.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
1
|
“Active Ingredient
Price(s)” shall have the meaning set forth in Section 8.1(a)
hereof.
“Active Ingredient
Specifications” shall mean the specifications for the Active Ingredient
attached hereto as Exhibit 2 and made a
part hereof, as determined in accordance with this Agreement, the analytical
methodology set forth and in accordance with the terms and conditions of the
Quality Agreement.
“Affiliate” shall mean
any corporation or non-corporate entity which controls, is controlled by, or is
under common control with a Party. A corporation or non-corporate
entity shall be regarded as in control of another corporation if it owns or if
it directly or indirectly controls at least fifty percent (50%) of the voting
stock of the other corporation or (a) in the absence of the ownership of at
least fifty percent (50%) of the voting stock of a corporation or (b) in
the case of a non-corporate entity, the power to direct or cause the direction
of the management and policies of such corporation or non-corporate entity, as
applicable.
“Agreement” shall mean
this Manufacturing and Supply Agreement, as it may hereafter be amended or
supplemented from time to time.
“cGMPs” shall mean
applicable standards for current good manufacturing practices of active
ingredients specified in (i) the ICH Guidelines,(ii) the FDA’s “Guidance for
Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients”, and (iii) the EU GMP Guidelines. For clarity, such
definition of cGMPs shall not include other country-specific regulatory
requirements.
“Certificate of
Analysis” shall mean a document, signed by an authorized representative
of SAD, certifying the Specifications for, and testing methods applied to, the
Active Ingredient, and the results thereof, and which includes the Active
Ingredient date of manufacture, date for re-testing or expiration date as
appropriate.
“Certificate of cGMP
Compliance” shall mean a document, signed by an authorized representative
of SAD, certifying that the Active Ingredient being delivered to Buyer has been
manufactured in conformity with cGMPs.
“Confidential
Information” shall mean, as the case may be, any and all information
relating to the Active Ingredient, of a confidential nature not known to the
public or to the recipient of the information before its disclosure belonging to
either Party in written, electronic or any other form. This includes, but is not
limited to, Know-How, operational methods, formulae, samples, Specifications,
analytical methods as well as any details of commercial, technical,
pharmaceutical, scientific and industrial nature. The terms of this Agreement
shall also be deemed Confidential Information. Confidential
Information shall not include information, materials, technical data or Know-How
which: (i) is in a receiving Party’s possession at the time of disclosure as
evidenced by the receiving Party’s written records immediately prior to the time
of disclosure; (ii) is in the public domain at the time of disclosure; (iii)
becomes part of the public domain by publication or otherwise after disclosure
hereunder other than by breach of this Agreement by a receiving Party; (iv) is
disclosed to a receiving Party by a third party having the right to disclose
such information without any violation of any rights of or obligations to the
disclosing Party; or (v) is independently developed by an employee or agent of a
receiving Party without knowledge of the disclosing Party’s Confidential
Information as evidenced by the receiving Party’s written records.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
2
|
“FDA” shall mean the
United States Food and Drug Administration or any successor entity
thereto.
“FDCA” shall mean the
Federal Food, Drug and Cosmetic Act (21 U.S.C. § et seq.), as the same may be
amended from time to time, together with any rules and regulations promulgated
thereunder, and any foreign counterpart.
“Force Majeure Event”
shall have the meaning set forth in Section 18.1 hereof.
“ICH Guidelines” shall
mean the document titled “Q7A - Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients” endorsed by the International Conference on
Harmonisation of Technical Requirements for Registrations of Pharmaceuticals
for
“Invention” shall mean
information relating to any innovation, improvement, development, discovery,
computer program, device, trade secret, method, Know-How, process, technique or
the like, whether or not written or otherwise fixed in any form or medium,
regardless of the media on which contained and whether or not patentable or
copyrightable.
“Know-How” shall mean
all confidential and identified technical and scientific information and data,
irrespective of its subject-matter and form, including, but not limited to,
processes, formulae, designs and data as well as Inventions and improvements
whether patentable or not.
“Packaging
Specifications” shall mean the packaging and labeling specifications for
the Active Ingredient attached hereto as Exhibit 1 and made a
part hereof, as such specifications may be amended from time to time by mutual
agreement of the Parties in accordance with the terms and conditions of the
Quality Agreement.
“PO” shall have the
meaning set forth in Article 6 hereof.
“Product” shall mean
Buyer’s finished oral insulin product
“Production Site”
shall mean [the SAD site in which it manufactures the Active Ingredient i) the active
pharmaceutical ingredient facility owned by SAD or an Affiliate of SAD (both
directly or indirectly under the control of Sanofi-Aventis, SA, the French
parent company) located at Industriepark Hoechst, 65926, Frankfurt am Main,
Germany, and (ii) such other facilities owned by SAD or an Affiliate of SAD, if
any, as the Parties may mutually agree to in writing from time to
time].
“Quality Agreement”
shall mean the Quality Agreement which the parties shall in good faith negotiate
and execute within thirty (30) days after the execution of this Agreement, and
which shall be made part hereof.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
3
|
“Recall” shall have
the meaning set forth in Section 12.2(a) hereof.
“Recalled Product”
shall mean any Product subject to a Recall.
“Regulatory Change”
shall have the meaning set forth in Section 18.2 hereof.
“Specifications” shall
mean the Active Ingredient Specifications and the Packaging
Specifications.
“Term” shall have the
meaning set forth in Section 11.1 hereof.
“Territory” shall mean
those territories set forth in Exhibit 4 as may be modified from time to time
only in accordance with the terms of the Agreement.
“Third Party” shall
mean any person or entity other than Buyer, SAD and their respective
Affiliates.
“Third Party Claims”
shall have the meaning set forth in Section 13.1 hereof.
ARTICLE
2
MANUFACTURE, SALE AND
PURCHASE OF ACTIVE INGREDIENT
2.1 Generally. Subject
to the terms and conditions of this Agreement, SAD shall manufacture and supply
to Buyer and Buyer shall exclusively purchase from SAD, all of its Active
Ingredient required to conduct clinical trials used to register the Product for
sale in the Territory. For clarification,
Buyer shall not use any clinical trial or data related thereto to register
Product in the Territory unless the active ingredient for such clinical trial is
supplied by SAD.
2.2 Additional
Territories. Should Buyer seek to conduct clinical trials
outside the Territory in order to register the Product outside the Territory,
then Buyer will discuss with SAD a proposal for SAD to supply Active Ingredient
for those trials, and SAD will make its best commercial efforts in order
accommodate Buyer’s commercially reasonable requirements.
ARTICLE
3
PACKAGING
SAD shall procure all packaging
materials and components for, and shall package, the Active Ingredient in
accordance with the Production Site receipt procedures and the Packaging
Specifications as set forth in Exhibit 1 attached
hereto. Typical packaging materials and components are described in
the Drug Master File in respect of the Active Ingredient and the use thereof is
supported by extant stability data.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
4
|
ARTICLE
4
COOPERATION WITH
GOVERNMENTAL REQUIREMENTS
The Parties shall cooperate with one
another as may be reasonably necessary or appropriate to satisfy all
governmental requirements and obtain all needed permits, approvals and licenses
with respect to the manufacture and supply of the Active Ingredient. Such
cooperation shall include, without limitation but strictly in regards to United
States territories, communicating with regulatory authorities and making
available as promptly as practicable all information, documents and other
materials which result from the performance by SAD of its services hereunder
which Buyer is required to submit or which Buyer may otherwise reasonably
request in connection with governmental filings relating to the Active
Ingredient. The costs and expenses of such cooperation, if applicable, shall be
subject to the Parties’ mutual agreement. Notwithstanding the
foregoing, it shall be the responsibility of (i) Buyer to obtain and maintain
all such permits, approvals and licenses which are specific to the Active
Ingredient or the Product, and (ii) SAD to obtain and maintain all such permits,
approvals and licenses which are generally required for the Production Site and
to maintain the Drug Master File in respect of the Active
Ingredient.
ARTICLE
5
SPECIFICATION
CHANGES
Upon any change in the Active Ingredient
Specifications or Packaging Specifications requested by Buyer (“Buyer Specification
Changes”), including the addition of new packaging configurations, Buyer
shall promptly advise SAD in writing of any requested Buyer Specification
Changes, and SAD shall promptly advise Buyer as to the feasibility of the Buyer
Specification Changes, and if in SAD’s reasonably exercised discretion, the
Buyer Specification Changes are found to be commercially reasonable and
feasible, SAD will inform Buyer of any scheduling and/or price adjustments which
may result from the Buyer Specification Changes. Prior to
implementation of Buyer Specification Changes, the Parties shall negotiate in
good faith in an attempt to reach agreement on (a) the new Active Ingredient
Price for any Active Ingredient which embodies the Buyer Specification Changes,
(b) any amounts to be reimbursed by Buyer to SAD as described in the next
sentence of this paragraph, and (c) any other amendments to this Agreement which
may be necessitated by the Buyer Specification Changes (i.e., an adjustment to
the lead time for POs). Buyer shall reimburse SAD for the mutually agreed upon
reasonable expenses incurred by SAD as a result of the Buyer Specification
Changes, including, but not limited to, reimbursing SAD for its mutually agreed
validation and development costs, capital expenditure costs and costs for any
reasonable inventory of packaging components or other materials maintained by
SAD for purposes of this Agreement and consistent with the PO, and rendered
unusable as a result of the Buyer Specification Changes. If during
the Term, Buyer, in accordance with this Article 5, causes the amendment of
the Active Ingredient Specifications or Packaging Specifications so as to
render obsolete reasonable quantities of the Active Ingredient and/or materials
and components used to manufacture and package the Active Ingredient pursuant to
this Agreement on hand at SAD, Buyer shall purchase from SAD (i) all such
obsolete Active Ingredient at the Active Ingredient Prices then in effect, (ii)
all work-in-progress of the Active Ingredient at SAD’s actual cost thereof, and
(iii) at SAD’s Acquisition Cost, all such obsolete materials and components
obtained by SAD pursuant to its normal procurement policies to manufacture
quantities of the Active Ingredient pursuant to the PO. SAD’s normal
procurement policies for purposes of the preceding sentence of this Article 5
shall be considered to be quantities of materials and components corresponding
to the PO. For greater certainty, the foregoing provisions of this
Article 5 shall not apply in respect of any change in the Active Ingredient
Specifications or Packaging Specifications made by SAD other than pursuant to a
Buyer request. SAD shall provide Buyer with not less than three (3)
months’ prior written notice of SAD’s implementation of any intended significant
change(s) to its manufacturing processes for the Active Ingredient, which might
affect the quality of the Active Ingredient (“Change Notice”) (e.g.
any change in the Active Ingredient Specifications or Packaging Specifications
made by SAD other than pursuant to a Buyer request). If a significant
change is implemented by SAD and Buyer provides SAD with demonstrable evidence
that the utility (i.e. the conditions of being useful as a pharmaceutical
product in connection with the manufacture and performance of the Product) of
the Active Ingredient is significantly altered in that there is no similar
bioequivalence (to Active Ingredient before the significant change) or similar
Product specifications when formulated in the final Product formulation
(together, “Utility
Loss”), the parties shall exert their best commercial efforts to resolve
issues related to the Utility Loss in order to continue operating under this
Agreement. If the parties cannot reach agreement and resolution
regarding Utility Loss, Buyer shall have the option to provide sixty (60) days
written notice of termination of this Agreement to SAD.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
5
|
ARTICLE
6
FORECASTS AND
ORDERS
6.1 Communication of Forecasts
and Purchase Orders by Buyer. Subject to and upon [REDACTED],
and subsequent finalization of Buyer’s continuing trial(s) design(s), Buyer
shall submit in writing to SAD a binding purchase order (“the PO”) of all clinical
quantities of Active Ingredient which are required to conduct such clinical
trials of Product.
SAD will
supply the Active Ingredient in packaging in accordance with the Packaging
Specifications set forth in Exhibit 1.
6.2 Confirmation by
SAD. No later than fifteen (15) business days after receipt of
Buyer’s POs, SAD shall confirm that it can fulfill the monthly quantities
specified in such orders.
6.3 Intentionally
omitted.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
6
|
6.4 Purchase
Orders. Buyer shall issue the PO for all known total clinical
quantities of Active Ingredient from SAD which are required to conduct [REDACTED]
of Product at the Active Ingredient Price. The quantities of the
Active Ingredient and the PO dates will be dependent upon the relevant
regulatory authorities’ responses to the Product’s clinical trials, whether
during review of the clinical program or after completion of clinical trial
which may necessitate further trials, regarding trial participant number,
dosage, length, and other relevant factors. Buyer estimates that it
will require a quantity of Active Ingredient greater or equal to [REDACTED]for
the anticipated clinical trials, and that the PO related thereto shall occur
within the year 2011. The only quantities that Buyer is bound to
purchase shall be those as determined in accordance with section
6.1. PO(s) for quantities up to 10KG shall be issued by Buyer at
least three (3) months in advance of the expected date of delivery of Active
Ingredient from SAD to Buyer. PO(s) for quantities from 10KG to 50KG
shall be issued by Buyer at least six (6) months in advance of the expected date
of delivery of Active Ingredient from SAD to Buyer. In the event that Buyer
submits PO(s) for quantities above 50KG, the parties shall discuss and negotiate
in good faith the lead time and advance notice required for delivery of Active
Ingredient to Buyer. SAD shall deliver to Buyer those quantities
ordered on a PO issued in accordance with this section 6.4 within the respective
timeframe set out in immediately above. For clarification, regardless
of expiration or termination of this Agreement, Buyer is obligated to pay any
amounts due in accordance with issued POs.
ARTICLE
7
DELIVERIES
7.1 Purchase Quantities.
SAD will use commercially reasonably efforts to ship the quantities specified in
the PO. Variations in shipments as outlined herein shall
be deemed to be in compliance with such PO; provided, however, that Buyer
shall only be invoiced and required to pay for the quantities of Active
Ingredient which SAD actually ships to Buyer. Quantities shipped are
subject to the Packaging Specifications set out in Exhibit 1
hereto.
7.2 Active Ingredient
Release. No Active Ingredient shall be released to Buyer
without a Certificate of Analysis and Certificate of cGMP Compliance, both of
which shall be supplied to Buyer by SAD. SAD shall conduct such
quality assurance testing for the Active Ingredient as is required by the
Specifications[,] [and ]cGMPs[ and the Quality Agreement. SAD shall
conduct in parallel on-going stability studies of the Active
Ingredients].
7.3 Delivery Terms.
Shipment of the Active Ingredient will be to one location as designated by
Buyer. Buyer will select and pay the carrier to be
used. The Active Ingredient will be shipped with the requisite
Certificates of Analysis and Certificate of cGMP Compliance, FCA Production Site
(Incoterms 2000), freight class, Class 70 (Class of Commodity for Food and
Pharmaceutical Compound). Loading of the Active Ingredient shall be
performed at no cost by SAD, but under the responsibility and liability of
Buyer. All shipments of the Active Ingredient to Buyer shall be made
via such carrier(s) as Buyer may direct. Title and risk of loss shall
pass to Buyer upon delivery to the carrier. Freight charges shall be
billed ship collect.
7.4 Shipping; Dating and Customs
Costs. SAD shall make commercially reasonable efforts to cause Active
Ingredient delivered hereunder to have [REDACTED]months
until expiration, but in any event, SAD shall deliver Active Ingredient
hereunder with at least twelve (12) months until expiration. For clarity,
costs for the shipment of Active Ingredient from the Production Site and all
customs tariffs and duties shall be for the account of Oramed.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
7
|
7.5 Inconsistencies. In
the event of any inconsistencies between the terms of this Agreement and the PO
issued by Buyer hereunder or any acceptance thereof by SAD, the terms of this
Agreement shall govern.
7.6 Inspections by
Buyer. With reasonable written notice and upon a mutually
agreed upon date, Buyer or its designated agents shall have the right to inspect
those portions of the manufacturing, storage and warehouse facilities of a
Production Site where Active Ingredient is being manufactured or stored, during
regular business hours, to verify compliance with the terms and provisions of
this Agreement or for insurance inspection purposes. Unless for
reasonable cause, Buyer agrees to not inspect a Production Site more often than
one (1) time in a three-calendar year period or any other frequency mutually
agreed upon.
7.7 Governmental
Inspections. If SAD is notified that the Active Ingredient or
the Production Site will be subject to an inspection related to the Active
Ingredient, by any governmental authority of the Territory, SAD shall promptly
inform Buyer of such inspection and shall cooperate with and allow such
inspection to the extent required by applicable laws. Buyer shall not
have the right to be present at any meetings or events related to such
inspection. Subject to being excluded due to restrictions under
confidentiality obligations of SAD to Third Parties, and to SAD’s determination
that particular information and/or documentation is confidential in nature, SAD
shall provide information related to inspection outcomes to Buyer resulting from
such inspection to the extent relevant to the Active Ingredient. SAD
will promptly inform Buyer whether any Form FDA 483 or warning letters or
citations are issued to SAD (by the FDA or any other governmental authority)
which are related to or impact the supply of the Active Ingredient to
Buyer.
ARTICLE
8
PRICE; PRICE ADJUSTMENTS;
PAYMENT TERMS
8.1 Price.
(a) General. The
per- gram price(s) payable by Buyer for all quantities of the Active Ingredient
ordered hereunder (the “Active Ingredient
Price(s)”) shall be [REDACTED]Euros[REDACTED].
8.2 Payment Terms. SAD
shall invoice Buyer for all quantities of the Active Ingredient purchased
hereunder concurrently with SAD’s shipment thereof to Buyer. Subject to Section
7.3 and Section 13.1, all amounts properly invoiced by SAD hereunder shall be
due and payable [REDACTED]from
the date of such invoice. SAD shall deliver invoices to Buyer on the
date the invoice is issued. Payment may be made by Buyer’s corporate check or by
wire transfer of funds to such account as SAD may designate. Orders,
invoices and payments under this Agreement shall be made in
Euros. Invoices shall reflect the actual quantities shipped and Buyer
shall be responsible for payment for such actual quantities shipped in
accordance with this Agreement.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
8
|
ARTICLE
9
SAD’S REPRESENTATIONS,
WARRANTIES AND COVENANTS
SAD
represents, warrants and covenants to Buyer as follows:
9.1 Active Ingredient.
The Active Ingredient, at the time of sale and shipment to Buyer by SAD, (a)
will conform to the Specifications, as then in effect, (b) will have dating
until re-evaluation of not less than that which is set forth in Section 7.4
above, (c) will have been manufactured in all material respects in accordance
with cGMP in effect at the time of manufacture, (d) will not be adulterated or
mis-branded within the meaning of the FDCA, (e) will not have been manufactured,
sold or shipped in violation of any applicable laws in any material respect, (f)
will be conveyed with good title, free and clear of all security interests,
liens or encumbrances, and (g) as may be appropriate or applicable, will have
been approved by any and all requisite governmental and regulatory
authorities.
9.2 Manufacturing
Standards. SAD shall manufacture the Active Ingredient in accordance with
(i) the Specifications, (ii) then-current cGMPs, and (iii) ICH
Guidelines.
9.3 Compliance with Applicable
Laws. SAD shall fully comply with all applicable federal, state and local
laws in performing the services contemplated hereunder.
9.4 Qualified Personnel.
SAD shall engage and employ only professionally qualified personnel to perform
the services contemplated hereunder, and will not knowingly utilize any
individual, in any material capacity, who has been debarred under FDCA 21 USC
335a or who is subject to a conviction described in FDCA 21 USC
331.
9.5 SAD
represents and warrants to Buyer that the Production Site is wholly-owned by an
Affiliate of SAD and that such Affiliate and SAD are wholly owned, directly or
indirectly, by Sanofi-Aventis SA.
ARTICLE
10
GENERAL REPRESENTATIONS AND
WARRANTIES
Each
Party represents and warrants to the other as follows:
10.1 Power and
Authorization. It has all requisite power and authority (corporate and
otherwise) to enter into this Agreement and has duly authorized by all necessary
action the execution and delivery hereof by the officer or individual whose name
is signed on its behalf below.
10.2 No Conflict. Its
execution and delivery of this Agreement and the performance of its obligations
hereunder do not and will not conflict with or result in a breach of or a
default under its organizational instruments or any other agreement, instrument,
order, law or regulation applicable to it or by which it may be
bound.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
9
|
10.3 Enforceability. This
Agreement has been duly and validly executed and delivered by it and constitutes
its valid and legally binding obligation, enforceable in accordance with its
terms, except as enforcement may be limited by bankruptcy, insolvency or other
laws of general application relating to or affecting the enforcement of
creditors’ rights and except as enforcement is subject to general equitable
principles.
10.4 Debarment. As
of the Effective Date, both parties have not been debarred under 21 USC 335a,
and to the best of their knowledge, is not subject to pending debarment under 21
USC 335a.
ARTICLE
11
TERM;
TERMINATION
11.1 Term. Unless sooner
terminated pursuant to the terms hereof, the term of this Agreement shall
commence on the Effective Date and shall expire with the acceptance by Buyer of
the total quantities of Active Ingredient as set forth in Article 6
above.
11.2 Termination by Buyer for
Utility Loss. Buyer shall be entitled to terminate this
Agreement pursuant to and in accordance with Article 5 in the event of a Utility
Loss. In the event of a termination by Buyer in accordance with this
Section 11.2 and Article 5, Buyer’s then-current payment obligations under this
Agreement which are not related to Utility Loss shall remain until fully
satisfied, including the payment of amounts due to SAD for Active Ingredient or
otherwise, which are not related to Utility Loss.
11.3 Termination by Mutual
Agreement. The Parties may terminate this Agreement at any time by mutual
written agreement.
11.4 Termination Upon
Breach. Either Party may terminate this Agreement upon not less than
thirty (30) days prior written notice to the other Party upon the material
breach or default by the other Party of any of its representations, warranties,
covenants or agreements (provided, however, that such
notice period shall be extended by such additional period as the breaching Party
may request upon the breaching Party’s written certification that (i) such
breach is reasonably capable of being cured within the period of the proposed
extension, but not within such thirty (30) day period and (ii) it has commenced
and is diligently pursuing efforts to cure such breach). Upon the expiration of
such notice period, this Agreement shall terminate without the need for further
action by either Party; provided, however, that if the
breach upon which such notice of termination is based shall have been fully
cured to the reasonable satisfaction of the non-breaching Party within such
notice period, then such notice of termination shall be deemed rescinded, and
this Agreement shall be deemed reinstated and in full force and effect. Such
right of termination shall be in addition to such other rights and remedies
specified in this Agreement and as provided by law. For greater
certainty, any breach or default (material or otherwise) by a Party under any
other agreement between the Parties (other than the Quality Agreement) shall not
entitle the other Party to terminate this Agreement.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
10
|
11.5 Other
Termination. Either of the Parties may terminate this
Agreement at anytime, upon written notice, during the clinical development of
Product should Buyer execute and enter into binding agreements with [REDACTED]as
a marketing partner related to the Product. Upon termination in
accordance with this section 11.5, Buyer will compensate SAD for [REDACTED]of
Active Ingredient shipped from SAD in accordance with a Letter of Intent between
the parties, effective November 1, 2009, at a rate of [REDACTED],
totaling [REDACTED]. Should
Buyer enter into marketing partnerships for the Product with partners other than
[REDACTED],
Buyer shall remain obligated to the terms of this Agreement with
SAD.
11.6 Rights and Duties Upon
Termination.
(a) Unless
otherwise mutually agreed by the Parties, SAD shall manufacture and ship, and
Buyer shall purchase in accordance with the provisions hereof, all quantities of
Active Ingredient ordered by Buyer hereunder prior to the date of expiration or
termination.
(b) Upon
the expiration or termination of this Agreement (other than termination by Buyer
pursuant to Section 11.2 or Section 11.4 hereof), Buyer shall, if so
requested by SAD, purchase (i) all materials and components acquired by SAD
hereunder to manufacture the Active Ingredient in accordance with the
then-current Forecast, at SAD’s Acquisition Cost thereof, (ii) all
work-in-progress of the Active Ingredient in respect of the then-current
Forecast at SAD’ actual cost thereof, and (iii) all finished Active
Ingredient inventory in respect of the then-current Forecast then in SAD’s
possession at the then-current Active Ingredient Price hereunder. In addition,
in such case Buyer shall pay SAD for any uncancellable commitments made by SAD
for materials and components hereunder in respect of the then-current
Forecast. Notwithstanding anything to the contrary in this Section
11.6 (b), the foregoing purchase and payment obligations of Buyer shall be
limited solely to materials and components obtained as to the time periods for
the types of materials and components provided in Article 5, and Active
Ingredient quantities manufactured as to which Buyer’ Forecasts under Section
6.1 hereof constitute a firm commitment.
ARTICLE
12
CLAIMS;
RECALLS
12.1 Claims. Buyer may
reject any quantity of the Active Ingredient which fails to conform to any
applicable PO, warranty, Specifications or laws upon written notice to SAD
describing such nonconformity given within thirty (30) days after Buyer’s
receipt thereof (or, in the case of any defects not reasonably susceptible of
discovery upon receipt of such goods, within thirty (30) days after discovery
thereof by Buyer). SAD shall have no liability to Buyer with respect
to any such nonconformity which the Parties agree (or, absent such agreement,
which a mutually acceptable independent laboratory or consultant determines) (i)
was caused by information supplied by Buyer or due to a fault in materials
supplied by Buyer, (ii) was otherwise caused by Buyer or its agents, or
(iii) was caused after delivery thereof to the carrier at the point of
origin. In all other cases, SAD shall promptly credit Buyer’s account
for SAD’s invoice price to Buyer of such nonconforming Active
Ingredient. Additionally, if Buyer shall have previously paid for
such nonconforming Active Ingredient, SAD shall promptly, at Buyer’s election,
either (a) refund the invoice price thereof (b) offset the amount
thereof against other amounts then due SAD hereunder or (c) replace such
nonconforming Active Ingredient with conforming Active Ingredient at no
additional cost to Buyer (including replacement shipping costs). THE
FOREGOING REMEDY CONSTITUTES THE EXCLUSIVE REMEDY AGAINST SAD AND THE ENTIRE
LIABILITY OF SAD IN CONNECTION WITH THE REJECTED SHIPMENT. The fees
and expenses of any independent laboratory or consultant engaged by the Parties
for purposes of this section shall be paid by the Party which is determined to
bear responsibility for the nonconformity in question
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
11
|
12.2 Recalls.
(a) Notices. Each
Party shall notify the other of any information, whether received directly or
indirectly, which might affect the marketability, safety or effectiveness of
Product which was manufactured using Active Ingredient supplied by SAD hereunder
and/or which might result in the Recall or seizure of the Product which was
manufactured using Active Ingredient supplied by SAD hereunder. For purposes of
this Agreement, a “Recall” shall mean
any action: (i) by either Party to recover title to or possession of quantities
of the Product which was manufactured using Active Ingredient supplied by SAD
hereunder sold or shipped to Third Parties (including, without limitation, the
voluntary withdrawal of such Product which was manufactured using Active
Ingredient supplied by SAD hereunder from the market) or (ii) by any regulatory
authority to detain or destroy any of such Product which was manufactured using
Active Ingredient supplied by SAD hereunder. “Recall” shall also
include the election by either Party to refrain from selling or shipping
quantities of such Product which was manufactured using Active Ingredient
supplied by SAD hereunder to Third Parties that would have been subject to a
Recall if sold or shipped.
(b) Discretion. Buyer
shall institute a Recall of the Product as a consequence of any defect that
Buyer deems sufficiently serious. Buyer shall consult with SAD regarding any
Recall of Product which was manufactured using Active Ingredient supplied by SAD
hereunder; provided, however, that Buyer
shall retain sole discretion whether to institute a Recall. SAD shall
provide a rapid initial response and a full report with respect thereto within
thirty (30) calendar days of such notification.
(c) Responsibilities. SAD
shall have no liability to Buyer with respect to any Recall which the Parties
agree (or, absent such agreement, which a mutually acceptable independent
laboratory or consultant determines) (i) was caused by information or materials
supplied by Buyer, (ii) was otherwise caused by Buyer or its agents,
(iii) was caused by factors occurring after delivery of the Active
Ingredient to the carrier at the point of origin, or (iv) did not result from a
breach of SAD’s warranties provided under Article 10 hereof. In
addition, Buyer shall reimburse SAD for all reasonable out-of-pocket Third Party
costs and expenses incurred and not recovered by SAD directly resulting from
such Recall (subject to the limitations set forth in Section 15.2
hereof).
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
12
|
(d) SAD
Liability. For all Recalls which result from a breach of SAD’s
warranties provided under Article 10 hereof, unless SAD does not have liability
pursuant to Section 12.2(c), SAD shall: (x) promptly credit Buyer’s account for
SAD’s invoice price to Buyer of the Active Ingredient used in such Recalled
Product; if Buyer shall have previously paid for such Active Ingredient, SAD
shall promptly, at Buyer’ election, either (A) refund the invoice price
thereof, or (B) offset the amount thereof against other amounts then due
SAD hereunder, or (C) replace such Active Ingredient at no additional cost
to Buyer (including shipping costs); and (y) reimburse Buyer for all reasonable
out-of-pocket Third Party costs and expenses incurred and not recovered by Buyer
directly resulting from such Recall (subject to the limitations set forth in
Section 15.2 hereof).
(e) Independent Laboratory
Costs. The fees and expenses of any independent laboratory or
consultant engaged by the Parties for purposes of this Section 12.2 shall be
paid by the Party which is determined to bear responsibility for the Recall in
question.
(f) Limitation. Notwithstanding
any other provision of this Agreement, the liability of SAD to reimburse Buyer
for Third Party costs and expenses pursuant to Section 12.2(d)(y) hereof related
to any Recall shall not exceed [REDACTED]in
respect of each such Recall. The Parties shall, to the extent
possible, meet to review, in advance, actions and budgets for any Recall for
which SAD shall have financial responsibility to Buyer pursuant to this Section
12.2.
12.3 Disposition of Nonconforming
or Recalled Product. Buyer shall not dispose of any damaged,
nonconforming or Recalled Product as to which it intends to assert a claim
against SAD without SAD’s written authorization to do so. Alternatively, SAD may
instruct Buyer to return such Product to SAD. SAD shall bear the cost of
disposition (as well as all applicable shipping costs) with respect to any
damaged, nonconforming or Recalled Product as to which it bears responsibility
under Section 12.1 or 12.2 hereof.
ARTICLE
13
INDEMNIFICATION
13.1 By Buyer. Buyer shall
defend, indemnify and hold harmless SAD, its Affiliates and their respective
officers, directors, shareholders, employees, licensees, agents, successors and
assigns from and against any and all claims, demands, damages, judgments,
settlements and awards made by or asserted by Third Parties (collectively,
“Third Party
Claims”) (including, without limitation, those associated with a Recall)
which any of them may incur or become subject to arising out of or resulting
from (a) Buyer’s use, handling, distribution, marketing or sale of the
Active Ingredient or the Product (subject to Section 13.2 hereof), (b) the
breach by Buyer of any of its representations, warranties, covenants,
obligations, agreements or duties under this Agreement or (c) any claim
that the manufacture, use or sale of the Product infringes a patent or any other
proprietary rights; provided, however, that such
obligation to indemnify shall not extend to any Third Party Claim to the extent
they arise out of or resulting from any negligence, recklessness or wrongful
conduct by SAD or the breach by SAD of any of its representations, warranties,
covenants, obligations, agreements or duties under this Agreement.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
13
|
13.2 By SAD. SAD shall
defend, indemnify and hold harmless Buyer, its Affiliates and their respective
officers, directors, shareholders, employees, licensees, agents, successors and
assigns from and against any and all Third Party Claims which any of them may
incur or become subject to arising out of or resulting from (a) SAD’s negligent
acts or omissions or willful misconduct in connection with the performance of
the services contemplated by this Agreement, (b) the breach by SAD of any
of its representations, warranties, covenants, obligations, agreements or duties
under this Agreement, or (c) any claim that SAD’s manufacture, use or sale of
the Active Ingredient alone infringes a patent or any other proprietary rights;
provided, however, that such
obligation to indemnify shall not extend to any Third Party Claim to the extent
they arise out of or resulting from any negligence, recklessness or wrongful
conduct by Buyer or the breach by Buyer of any of its representations,
warranties, covenants, obligations, agreements or duties under this
Agreement.
13.3 Procedure. Promptly
after learning of the occurrence of any event which may give rise to its rights
under the provisions of this Article 13, each indemnitee hereunder shall give
written notice of such matter to the indemnitor. The indemnitee shall cooperate
with the indemnitor in the negotiation, compromise and defense of any such
matter. The indemnitor shall have the right to be in charge of and control such
negotiations, compromise and defense and to select and manage counsel with
respect thereto, provided that the indemnitor shall promptly notify the
indemnitee of all developments in the matter. In no event shall the
indemnitee compromise or settle any such matter without the prior written
consent of the indemnitor, who shall not be bound by any such compromise or
settlement absent its prior written consent, which consent shall not be
unreasonably withheld or delayed
ARTICLE
14
INSURANCE
Each Party represents that it has and
shall maintain during the Term hereof, as well as after the expiration or
termination of this Agreement, sufficient insurance or an appropriate program of
self insurance, and in particular products liability insurance, with appropriate
policy limits to cover all risks associated with the performance of its
obligations under this Agreement. Each Party agrees to provide upon
request copies of the relevant certificate(s) of insurance.
ARTICLE
15
LIMITATION OF
LIABILITY
15.1 DISCLAIMER OF
WARRANTIES. THE WARRANTIES GIVEN BY SAD HEREUNDER ARE IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ALL OTHER
WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED BY SAD.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
14
|
15.2 DAMAGES. NO PARTY
SHALL BE LIABLE FOR ANY INCIDENTAL, INDIRECT, PUNITIVE, SPECIAL OR CONSEQUENTIAL
DAMAGES OF ANY KIND (INCLUDING, WITHOUT LIMITATION, LOST PROFITS AND LOSS OF
GOODWILL) ARISING FROM ANY BREACH OR ALLEGED BREACH OF THIS AGREEMENT (EVEN IF
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES).
15.3 Remedies. SAD’s
sole obligations, and Buyer’s sole and exclusive remedies, for any breach by SAD
of this Agreement related to nonconforming Active Ingredient or Recalled Product
shall be as set forth in Sections 12.1 and 12.2 hereof,
respectively.
15.4 LIMITATION. EXCEPT
FOR SAD’S INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS, IN NO EVENT SHALL
SAD’S TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS OR LOSSES ARISING OUT OF OR
RELATED TO THIS AGREEMENT EXCEED THE AMOUNTS PAID TO SAD HEREUNDER DURING THE
TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO
LIABILITY.
ARTICLE
16
CONFIDENTIALITY
16.1 Treatment of Confidential
Information. Except as otherwise provided in this Article 16, during
the Term and for a period of ten (10) years thereafter:
|
|
(i)
|
SAD
will retain in confidence and use only for the purposes contemplated
hereby any Confidential Information disclosed to it by or on behalf of
Buyer in connection with the performance of this Agreement;
and
|
|
|
(ii)
|
Buyer
will retain in confidence and use only for the purposes contemplated
hereby any Confidential Information disclosed to it by or on behalf of SAD
in connection with the performance of this
Agreement.
|
16.2 Right to
Disclose. To the extent it is reasonably necessary or
appropriate to fulfill its obligations or exercise its rights under this
Agreement or any rights which survive termination or expiration hereof, each
Party may disclose Confidential Information to its Affiliates, sublicensees,
consultants, outside contractors, clinical investigators or other Third Parties
on condition that such entities or persons agree (a) to keep the
Confidential Information confidential for the same time periods and to the same
extent as each Party is required to keep the Confidential Information
confidential and (b) to use the Confidential Information only for such
purposes as such Party is entitled to use the Confidential Information. Each
Party or its Affiliates or sublicensees may disclose such Confidential
Information to government or other regulatory authorities to the extent that
such disclosure (i) is reasonably necessary to obtain patents or
authorizations to conduct clinical trials with and to market commercially the
Product, provided such Party is otherwise entitled to engage in such activities
under this Agreement or (ii) is otherwise legally required.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
15
|
16.3 Confidentiality
Agreement. This Agreement contains the entire understanding of the
Parties with respect to the Confidential Information and supersedes the
Confidentiality Agreement entered into on September 26, 2008.
16.4 Material Transfer
Agreement. The Material Transfer Agreement executed by the
parties shall remain in effect.
ARTICLE
17
OWNERSHIP OF
PROPERTY
17.1 Ownership of Rights.
Each Party shall exclusively own and retain all right, title and interest in and
to (i) all intellectual property rights, information, documents and tangible and
intangible materials owned by it as of the Effective Date, and (ii) all
Inventions which are conceived, reduced to practice, or created by such Party
and/or its Affiliates or agents (including without limitation Inventions based
upon any background or preexisting technology of such Party) and which do not
include any intellectual property rights of the other Party from and after the
Effective Date. Each Party shall be solely responsible for the
conduct and costs of filing, prosecution and maintenance of patents and patent
applications on its own intellectual property rights, including without
limitation its Inventions.
17.2 Trademarks. Buyer
shall retain all right, title and interest arising under the laws of the United
States and Israel and all other applicable laws in the trademarks of Buyer that
may be adopted with respect to the Product.
ARTICLE
18
FORCE
MAJEURE
18.1 Effects of Force
Majeure. Neither Party shall be held liable or responsible for failure or
delay in fulfilling or performing any of its obligations under this Agreement
(other than the payment of money owed hereunder) to the extent that such failure
or delay results from any cause beyond its reasonable control, including,
without limitation, fire, flood, natural disaster, explosion, war, strike, labor
unrest, riot, embargo, acts or omissions of carriers, or act of God (each, a
“Force Majeure
Event”). Such excuse shall continue as long as the Force Majeure Event
continues, following which such Party shall promptly resume performance
hereunder.
18.2 Effects of Regulatory
Changes. Neither Party shall be held responsible or liable for failure or
delay in fulfilling or performing any of its obligations under this Agreement to
the extent that such failure or delay results from good faith efforts to comply
with the enactment or revision of any law, rule, regulation or regulatory
advisory opinion or order applicable to the manufacturing, marketing, sale,
reimbursement and/or pricing of the Product (a “Regulatory Change”).
Such excuse shall continue as long as performance is prevented by the affected
Party’s good faith efforts to comply with such Regulatory Change, following
which such Party shall promptly resume performance hereunder.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
16
|
18.3 Notice. The Party
affected by a Force Majeure Event or a Regulatory Change shall notify the other
Party thereof as promptly as practicable after its occurrence. Such notice shall
describe the nature of such Force Majeure Event or Regulatory Change and the
extent and expected duration of the affected Party’s inability to fully perform
its obligations hereunder. The affected Party shall use due diligence, where
practicable, to minimize the effects of or end any such event so as to
facilitate the resumption of full performance hereunder and shall notify the
other Party when it is again fully able to perform such
obligations.
ARTICLE
19
INDEPENDENT
CONTRACTORS
The relationship between Buyer and SAD
is that of independent contractors and nothing herein shall be deemed to
constitute the relationship of partners, joint venturers, nor of principal and
agent between Buyer and SAD. Neither Party shall have any express or implied
right or authority to assume or create any obligations on behalf of or in the
name of the other Party or to bind the other Party to any contract, agreement or
undertaking with any Third Party.
ARTICLE
20
MISCELLANEOUS
20.1 General Notices.
Except as otherwise provided in Section 20.2 hereof, all notices, requests,
instructions, consents and other communications to be given pursuant to this
Agreement shall be in writing and shall be deemed received (i) on the same day
if delivered in person, by same-day courier or by facsimile transmission, (ii)
on the next day if delivered by overnight mail or courier, or (iii) on the date
indicated on the return receipt, or if there is no such receipt, on the third
calendar day (excluding Sundays) if delivered by certified or registered mail,
postage prepaid, to the Party for whom intended to the following
addresses:
|
If
to Buyer:
|
||
|
ORAMED
Ltd.
|
||
|
HI-TECH
PARK 2/5 GIVAT-RAM
|
||
|
PO
Box 39098, Jerusalem 91390, Israel
|
||
|
Attention:
CFO: Yifat Zommer
|
||
|
Email:
yifat@oramed.com
|
||
|
Facsimile:
+ 972 2 566 0004
|
||
|
If
to SAD:
|
||
|
SANOFI-AVENTIS
DEUTSCHLAND GMBH
|
||
|
Industriepark
Hoechst, 65926
|
||
|
Frankfurt
am Main,
Germany
|
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
17
|
|
With
a copy to:
|
sanofi-aventis
US
|
|
|
55
Corporate Drive
|
||
|
Bridgewater,
NJ 08807
|
||
|
General
Counsel
|
||
|
Facsimile:
908-927-8636
|
Each
Party may by written notice given to the other in accordance with this Agreement
change the address to which notices to such Party are to be
delivered.
20.2 Special Notices. Each
Party shall notify the other by telephone as soon as practicable (with written
confirmation within three business days) upon its receipt of any technical
complaint or notice of adverse reaction; provided, however, that
notification of serious, new or unexpected experiences reported with increased
frequency shall be made immediately (but in any event not more than thirty-six
(36) hours after the notifying Party learns of such experiences). All such
notices shall be directed to the Parties at the addresses set forth in Section
20.1 to the attention of the following personnel:
|
If
to Buyer:
|
||
|
Technical complaints:
|
Quality
Assurance Specialist
|
|
|
Adverse
reactions:
|
Director
of Product Surveillance
|
|
|
If
to SAD:
|
||
|
Technical complaints:
|
Site
Quality Manager
|
|
|
Adverse
reactions:
|
Site
Quality Manager
|
|
20.3 Entire Agreement.
This Agreement contains the entire understanding of the Parties with respect to
the subject matter hereof and supersedes all prior agreements and
understandings, whether written or oral, between them with respect to the
subject matter hereof. Each Party has executed this Agreement without reliance
upon any promise, representation or warranty other than those expressly set
forth herein.
20.4 Amendment. No
amendment of this Agreement shall be effective unless embodied in a written
instrument executed by both of the Parties.
20.5 Waiver of Breach. The
failure of either Party at any time to enforce any of the provisions of this
Agreement shall not be deemed or construed to be a waiver of any such provision,
nor in any way to affect the validity of this Agreement or any provisions hereof
or the right of any Party to thereafter enforce each and every provision of this
Agreement. No waiver of any breach of any of the provisions of this Agreement
shall be effective unless set forth in a written instrument executed by the
Party against whom or which enforcement of such waiver is sought; and no waiver
of any such breach shall be construed or deemed to be a waiver of any other or
subsequent breach.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
18
|
20.6 Neither
Party shall subcontract any of its obligations under this Agreement; provided, however, that (i)
either party may subcontract to a Third Party any of its obligations under this
Agreement with the prior written approval of the other Party, such approval not
to be unreasonably withheld, and (ii) SAD may subcontract any services to an
Affiliate, or otherwise if permitted in the Specifications or Packaging
Specifications, including without limitation the supply of materials and
components, or pursuant to Section 20.7 hereof.
20.7 Assignment; Requirement to
Assign to Successor to Business. Neither Party may assign its
rights under this Agreement in whole or in part without the prior written
approval of the other Party (such approval not to be unreasonably withheld or
delayed). Any such attempted assignment without such prior written consent shall
be void and ineffective. Notwithstanding the foregoing: SAD may, without the
other Party’s consent, assign its rights and delegate its duties under this
Agreement in whole or in part to any entity with which it merges or
consolidates, which acquires all or substantially all of its business and
assets, or which otherwise is or becomes an Affiliate of the assigning
Party;
20.8 Governing Law. This
Agreement shall be governed by and construed in accordance with the laws of New
York, USA, without regard to any choice-of-law principle that would dictate the
application of the laws of another jurisdiction. Failing amicable agreement, all
disputes arising in connection with this Agreement shall be settled by the
courts of New York, New York, USA.
20.9 Severability. All of
the provisions of this Agreement are intended to be distinct and
severable. If any provision of this Agreement is or is declared to be
invalid or unenforceable in any jurisdiction, it shall be ineffective in such
jurisdiction only to the extent of such invalidity or
unenforceability. Such invalidity or unenforceability shall not
affect either the balance of such provision, to the extent it is not invalid or
unenforceable, or the remaining provisions hereof, nor render invalid or
unenforceable such provision in any other jurisdiction.
20.10 Publicity. Nothing
in this Agreement shall be deemed to give either Party any rights to use the
other Party’s trademarks or trade names without the other Party's prior
specific, written consent. The parties agree that except for what has
been provided for herein, neither party will issue any press release or
otherwise make any public statement, advertisement or disclosure with respect to
this Agreement or the transactions contemplated hereby without the prior written
consent of the other Party, which shall not be unreasonably
withheld. The Parties agree that Exhibit 3 attached hereto represents
a mutually approved announcement and Form 8-K to be released and filed by Buyer
or its Affiliate with the Securities and Exchange Commission upon the full
execution of this Agreement. In addition, if, in the opinion of the
disclosing Party’s legal counsel, any other announcement is necessary to comply
with applicable law, either Party shall be entitled to make a further public
announcement of this Agreement and/or file forms with the Securities and
Exchange Commission or other regulatory agencies, subject to the prior review
and approval of such press release and/or forms by the other Party or its
Affiliate, which approval will not be unreasonably withheld or
delayed. In addition, if, in the opinion of Buyer's legal counsel
this Agreement must be filed with the Securities and Exchange Commission,
mutually agreed upon redacted versions of this Agreement may be exhibits to the
Form 8-K Current Report or a periodic report. In addition, Buyer will
be entitled to make reference to this Agreement in reports filed with the
Securities and Exchange Commission, after providing SAD reasonable advance
notice and a reasonable opportunity to review and comment
thereon. Finally, Buyer shall be allowed to insert the statement
"The recombinant human insulin
was sourced from Sanofi-Aventis Deutschland GmbH" without any
authorization from SAD in order to specify the SAD as the supplier of the
Active Ingredient only in peer-review papers and posters published
at scientific seminars when the Active Ingredient which was provided
by SAD is used for the studies that are the subjects of the
publication.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
19
|
20.11 Survival. The
provisions of Article 4 (Cooperation with Governmental Requirements), Section
11.5 (Rights and Duties Upon Termination), Article 12 (Claims; Recalls), Article
13 (Indemnification), Article 14 (Insurance), Article 15 (Limitation of
Liability), Article 16 (Confidentiality), Article 17 (Ownership of Property), ,
Section 20.8 (Governing Law), Section 20.10 (Publicity) and Section 24.11
(Survival) shall survive the expiration or termination of this
Agreement.
20.12 Headings. The
headings of articles and sections have been included for convenience only and
shall not be considered in interpreting this Agreement.
20.13 Counterparts; Facsimile
Signatures. This Agreement may be executed in one or more counterparts,
each of which shall be deemed to be an original, and all of which together shall
constitute one and the same Agreement. This Agreement may be executed and
delivered via facsimile or other electronic means with the same force and effect
as if it were executed and delivered by the Parties simultaneously in the
presence of one another.
20.14 Execution. At
the time of execution of this Agreement, the Parties shall cause their
authorized officers to execute two original copies of this Agreement, one copy
of which shall be maintained by each Party at that Party’s offices. Each Party
represents that the person who executes this Agreement is authorized and
empowered to obligate and bind his or her Party under this
Agreement.
20.15 Further Actions. The
Parties agree to execute such additional documents and / or agreements as may be
reasonably necessary to perfect the intentions of the provisions contained
herein.
[Remainder
of this page intentionally left blank.]
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
20
|
IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their respective duly
authorized representatives as of the date first written above.
ORAMED
LTD.
|
|
||
|
Name:
|
|
|
|
Title:
|
|
SANOFI-AVENTIS DEUTSCHLAND
GMBH
|
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
PAGE
21
|
Exhibit
1
PACKAGING
SPECIFICATIONS
SAD will
supply the Active Ingredient in packaging units of [REDACTED]
kilograms for a purchased quantity below [REDACTED]kg
and in packaging units of [REDACTED]kilograms
(standard preferred packaging unit) for a purchased quantity higher than [REDACTED]kilograms.
The
following sizes* of stainless steel drums are utilized for packaging and
delivery:
1[REDACTED][REDACTED]*
not factoring in the lid
SAD shall
have the right, at its option, to deliver ordered quantities in one drum where
feasible.
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
|
Exhibit
2
ACTIVE
INGREDIENT SPECIFICATIONS
[REDACTED]
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
|
Exhibit
3
Press
Release to be issued by Buyer
[REDACTED]
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
|
Exhibit
4
Territory
[REDACTED]
|
MANUFACTURING
AND SUPPLY AGREEMENT
|
|
Oramed
Pharmaceuticals and sanofi-aventis Enter into an Agreement for the Insulin
supply of Oramed’s Oral Insulin Capsules.
JERUSALEM,
Israel, July 7, 2010— Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB)
(http://www.oramed.com), a developer of oral delivery systems, today announced
that Oramed entered into a Manufacturing Supply Agreement (MSA) with
sanofi-aventis. According to the MSA, sanofi-aventis will supply Oramed with
specified quantities of recombinant human insulin to be used by Oramed for its
clinical trials in the USA.
The MSA
is managed by the Commercial and External Partnership within Industrial Affairs
(CEPiA) at sanofi-aventis, which will allow Oramed to leverage sanofi-aventis’
ability and expertise regarding quality and regulatory support.
“Oramed’s
oral delivery technology together with sanofi-aventis capabilities to produce
insulin on a large scale supports Oramed’s efforts to conduct clinical
development of Oramed’s oral insulin capsule in the growing diabetes market in
the US.”, says Nadav Kidron, Oramed’s CEO. “It is very satisfying to work with
such a professional company and their dedicated staff.”
About
Oramed Pharmaceuticals
Oramed
Pharmaceuticals is a technology pioneer in the field of oral delivery solutions
for drugs and vaccines presently delivered via injection. Oramed is seeking
to revolutionize the treatment of diabetes through its patented flagship
product, an orally ingestible insulin capsule currently in phase 2 clinical
trials. Established in 2006, Oramed’s technology is based on over 25 years of
research by top research scientists at Jerusalem’s Hadassah Medical Center. The
Company’s corporate and R&D headquarters are based in
Jerusalem.
For more
information, please visit http://www.oramed.com.
Safe
Harbor Statement
Some of
the statements contained in this press release are forward-looking statements
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, 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 for our product
candidates; competition from other pharmaceutical or biotechnology companies;
and the company's ability to obtain additional funding required to conduct its
research, development and commercialization activities. 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. The company undertakes no obligation
to update or revise any forward-looking statements.
Company
and Investor Relation Contacts:
Oramed
Pharmaceuticals Inc.
Tara
Horn
Office:
646-240-4193
Cell:
+972-54-334-4318
Email:
tara@oramed.com