THE MARKED PORTIONS OF THIS AMENDMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT
|
REDACTED
– AS FILED
|
Exhibit
10.2
|
THE
MARKED PORTIONS OF THIS AMENDMENT HAVE BEEN OMITTED
AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO
A
REQUEST FOR CONFIDENTIAL TREATMENT
RECOMBINANT
HUMAN INSULIN ACTIVE INGREDIENT
BETWEEN
GENEREX
BIOTECHNOLOGY CORPORATION
AND
SANOFI-AVENTIS DEUTSCHLAND
GMBH
DATED: NOVEMBER 24,
2009
TABLE OF
CONTENTS
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Article
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Title
|
Page
|
||
|
1
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Definitions
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1
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||
|
2
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Manufacture,
Sale and Purchase of Active Ingredient
|
5
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||
|
3
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Coordinators
|
6
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||
|
4
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Packaging
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6
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||
|
5
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Specification
Changes
|
7
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||
|
6
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Forecasts
and Orders
|
8
|
||
|
7
|
Registration
of the Product
|
9
|
||
|
8
|
Deliveries;
Inspections
|
9
|
||
|
9
|
Price;
Price Adjustments; Payment Terms
|
11
|
||
|
10
|
SAD’s
Representations, Warranties and Covenants
|
11
|
||
|
11
|
General
Representations and Warranties
|
12
|
||
|
12
|
Term;
Termination
|
13
|
||
|
13
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Claims;
Recalls
|
15
|
||
|
14
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Indemnification
|
17
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||
|
15
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Insurance
|
18
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||
|
16
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Limitation
of Liability
|
18
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||
|
17
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Confidentiality
|
19
|
||
|
18
|
Ownership
of Property
|
20
|
||
|
19
|
Intentionally
omitted.
|
20
|
||
|
20
|
Cooperation
with Governmental Requirements
|
20
|
||
|
21
|
Force
Majeure
|
20
|
||
|
22
|
Independent
Contractors
|
21
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||
|
23
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Further
Actions
|
21
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||
|
24
|
|
Miscellaneous
|
|
21
|
TABLE OF
SCHEDULES
|
Exhibit
|
Title
|
|
|
1
|
Territories: Exclusive
|
|
|
1A
|
Territories: Non-Exclusive
|
|
|
2
|
Active
Ingredient Prices
|
|
|
3
|
Packaging
Specifications
|
|
|
4
|
Active
Ingredient Specifications
|
|
|
5
|
Minimum
Purchase Commitments
|
|
|
6
|
|
In-Vitro
Physio-Chemical
Characterizations
|
|
REDACTED
– AS FILED
|
Exhibit
10.2
|
THE
MARKED PORTIONS OF THIS AMENDMENT HAVE BEEN OMITTED
AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO
A
REQUEST FOR CONFIDENTIAL TREATMENT
RECOMBINANT
HUMAN INSULIN ACTIVE INGREDIENT
(RECOMBINANT
HUMAN INSULIN COMMERCIAL QUANTITIES)
THIS MANUFACTURING AND SUPPLY
AGREEMENT (the “Agreement”) is made
effective as of November 24, 2009 (the “Effective Date”)
between:
generex
biotechnology corporation, a Delaware corporation having a place of
business at 00 Xxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxx, Xxxxxx X0X 0X0
(“Generex”);
and
Sanofi-Aventis
Deutschland GmbH, a company existing under the laws of
Germany, located at Xxxxxxxxxxxxx Xxxxxxx, 00000 Xxxxxxxxx xx Xxxx,
Xxxxxxx
( “SAD”).
Generex
and SAD are individually referred to herein as a “Party” and are
collectively referred to herein as the “Parties”.
Background
A. Generex
wishes to engage SAD to perform services for Generex, as more specifically set
forth herein, in connection with the manufacturing and supply of Active
Ingredient for use in the Product.
B. SAD
wishes to perform such services subject to 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.
“Active Ingredient
Price(s)” shall have the meaning set forth in Article 9
hereof.
“Active Ingredient
Specifications” shall mean the specifications for the Active Ingredient
attached hereto as Exhibit 4 and made a
part hereof, as determined in accordance with the analytical methodology set
forth therein, 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.
“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
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 in accordance with the terms hereof.
“[REDACTED]”
shall have the meaning set forth in Section 2.4 hereof.
“cGMPs” shall mean
applicable standards for current good manufacturing practices of active
ingredients specified in (i) the ICH Guidelines, and (ii) the FDA’s “Guidance
for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients”. 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 GMP
Compliance” shall mean a document, signed by an authorized representative
of SAD, certifying that the Active Ingredient being delivered to Generex 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.
“Contract Year” shall mean
a twelve (12) month period during the Term, beginning with January 1 and ending
on December 31, except that the first “Contract Year” shall be understood to be
from November 1, 2009 through December 31, 2009 and the last “Contract Year” for
the initial Term shall be understood to run from January 1, 2016 through October
31, 2016..
“Coordinators” shall
have the meaning set forth in Article 3 hereof.
“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.
“Forecast” shall have
the meaning set forth in Section 6.1 hereof.
“Force Majeure Event”
shall have the meaning set forth in Section 21.1 hereof.
“ICH Guidelines” shall
mean the document titled “Q7A - Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients” endorsed by the International Conference on
Harmonization of Technical Requirements for Registrations of Pharmaceuticals for
human use.
“Initial Term” shall
have the meaning set forth in Section 12.1 hereof.
“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.
“Minimum Purchase
Commitments” shall have the meaning set forth in Section 2.2
hereof.
“Packaging
Specifications” shall mean the packaging and labeling specifications for
the Active Ingredient attached hereto as Exhibit 3 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.
“Product” shall mean
Generex’s proprietary “Generex Oral-xxx™” product, formulated as a buccal
insulin spray device containing a proprietary formulation that includes the
Active Ingredient, marketed by Generex (or its licensee(s)) under the registered
trademark “GENEREX ORAL-XXX” (or otherwise).
“Production Site” or “Production Sites”
shall mean (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 Xxxxxxxxxxxxx Xxxxxxx,
00000, Xxxxxxxxx xx Xxxx, Xxxxxxx, 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.
“Recall” shall have
the meaning set forth in Section 13.2(a) hereof.
“Regulatory Change”
shall have the meaning set forth in Section 21.2 hereof.
“Renewal Term” shall
have the meaning set forth in Section 12.1 hereof.
“Specifications” shall
mean the Active Ingredient Specifications and the Packaging
Specifications.
“Term” shall have the
meaning set forth in Section 12.1 hereof.
“Territory” shall
mean, collectively, those territories set forth on Exhibit 1 and Exhibit
1A attached hereto.
“Third Party” shall
mean any person or entity other than Generex, SAD and their respective
Affiliates.
“Third Party Claims”
shall have the meaning set forth in Section 14.1 hereof.
“Third Party Offer”
shall be a third party’s documented offer for the sale of recombinant human
insulin to Generex for commercial production of the Product.
“USA” shall mean the
United States of America, including its territories and
possessions.
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 Generex and Generex shall purchase from SAD, the Active Ingredient during the
Term of this Agreement for the Territory and as specified in Section 2.2
below.
2.2 Purchase
Commitments. Generex shall observe and perform the minimum
purchase commitments specified and defined in Exhibit 5 hereto (the “Minimum Purchase
Commitments”) from the Effective Date through December 31,
2011. SAD shall be the exclusive supplier of Active Ingredient to
Generex during such period and thereafter through the Term of this Agreement for
those territories listed in Exhibit 1, and as a non-exclusive supplier of Active
Ingredient to Generex for those territories listed in Exhibit 1A, unless
otherwise agreed to be mutual agreement of the parties or in accordance with the
terms of this Agreement.
2.3 Quality Agreement.
The Parties shall comply in all respects with their obligations under the
Quality Agreement.
2.4 Capacity. Under
no circumstances shall SAD be obliged to accept orders or deliver the Active
Ingredient in quantities which, in the aggregate, are in [REDACTED].
Starting January 1, 2012 and thereafter, should Generex’s rolling forecast(s)
(as outlined in Article 6 below), be in [REDACTED],
the parties shall discuss such forecast(s) and SAD shall have the right, at its
sole discretion, to deny or accept such [REDACTED]
forecast(s) or other terms discussed by the parties as set forth
above. Should SAD elect not to supply the [REDACTED],
Generex shall have the right to purchase Active Ingredient from another supplier
but only to the extent to obtain the quantities in the forecast not provided by
SAD.
2.5 Suppliers. SAD
shall have the discretion to determine sources and suppliers for all materials
and components used in the manufacture of the Active Ingredient, subject to
Article 5 hereof.
2.6 First Right of
Refusal.
(a)
During the Term, Generex will not accept any Third Party Offer or enter into any
arrangement pursuant to which Generex agrees to purchase the Active Ingredient
from a Third Party on an exclusive basis for Product to be sold in [REDACTED]
without first giving SAD a first right to refuse to exclusively supply Active
Ingredient to Generex for Product to be sold in [REDACTED]
on substantially the same terms as the Third Party Offer without material
variance.
(b) Upon
receipt by Generex of a bona
fide Third Party Offer that Generex is prepared to accept, Generex shall
apprise SAD in writing of the terms of the Third Party Offer.
(c) SAD
will have a period of thirty (30) days to from the date of delivery of the Third
Party Offer to deliver to Generex an offer in writing (the “SAD Offer”) to sell
Active Ingredient to Generex on an exclusive basis for Product to be sold in
[REDACTED]
upon the same terms as are contained in the Third Party Offer, which SAD Offer
shall be deemed accepted by Generex once received by Generex. Failure
to deliver the SAD Offer shall be deemed to be a waiver by SAD indicating
declination to exercise the first right of refusal set forth
herein. The parties shall execute an amendment to this Agreement
which shall reflect the SAD Offer and relevant terms related
thereto.
(d) If
SAD fails to submit the SAD Offer, Generex will be entitled, for a period of six
(6) months after the expiry of the time provided for delivery of the SAD Offer,
to execute and deliver contractual documentation formalizing the Third Party
Offer with such Third Party on and subject to the terms contained in the Third
Party Offer without material variance.
ARTICLE
3
COORDINATORS
Within
ten (10) days after the Effective Date, Generex and SAD shall each appoint one
or more authorized representatives (“Coordinators”) for
the exchange of all communications, other than formal notices hereunder, related
to the manufacture and supply the Active Ingredient. Each Party shall provide
notice to the other Party as to the name and title of the individuals so
appointed. Each Party may replace its Coordinators at any time for any reason by
providing written notice to the other Party in accordance with Section 24.1
hereof.
ARTICLE
4
PACKAGING
SAD
shall procure all packaging materials and components for, and shall package, the
Active Ingredient in accordance with the Packaging Specifications as set forth
in Exhibit 3 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.
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6
|
ARTICLE
5
SPECIFICATION
CHANGES
Upon any
change in the Active Ingredient Specifications or Packaging Specifications
requested by Generex (“Generex Specification Changes”), including the addition
of new packaging configurations, Generex shall promptly advise SAD in writing of
any requested Generex Specification Changes, and SAD shall promptly advise
Generex as to the feasibility of the Generex Specification Changes, and if in
SAD’s reasonably exercised discretion, the Generex Specification Changes are
found to be commercially reasonable and feasible, SAD will inform Generex of any
scheduling and/or price adjustments which may result from the Generex
Specification Changes. Prior to implementation of Generex
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 Generex Specification Changes, (b) any amounts to
be reimbursed by Generex 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 Generex Specification Changes (i.e., an adjustment to the
lead time for purchase orders). Generex shall reimburse SAD for the mutually
agreed upon reasonable expenses incurred by S AD as a result of the Generex
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 any
then-current Forecast, and rendered unusable as a result of the Generex
Specification Changes. If during the Term, Generex, 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, Generex 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 Generex’ forecasts under Section 6.1. 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 following six (6) months of Generex’s forecasted Active Ingredient
demand. 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
Generex request. SAD shall provide Generex with not less than six (6)
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 Generex request). If a significant change
implemented by SAD and Generex 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 Generex shall have the option to provide sixty (60) days
written notice of termination of this Agreement to SAD.
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7
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ARTICLE
6
FORECASTS AND
ORDERS
6.1 Communication of Forecasts
and Purchase
Orders by Generex.
Generex
shall by the end of each calendar quarter (commencing with the calendar quarter
ending December 31, 2009) provide SAD with its non-binding forecast of its
Active Ingredient requirements for the succeeding twelve (12) calendar months
(each a “Forecast”). Generex shall provide firm and binding Active
Ingredient purchase orders for 100% of the Q1 and Q2 amounts in each Forecast,
75% of the Q3 amounts in each Forecast, and 50% of the Q4 amounts in each
Forecast. In addition, Generex shall furnish SAD with a non-binding rolling
forecast of its Active Ingredient requirements for a subsequent twelve (12)
month period (for a total of twenty-four (24) months). Generex shall make its
commercially reasonable efforts to provide forecasts at least eighteen (18)
months in advance for annual orders that will [REDACTED].
Generex shall use its commercially reasonable efforts to provide accurate
Forecasts. Forecasts and SAD obligations to supply are subject to
[REDACTED]
set forth in Section 2.4 above.
Generex
shall place with SAD firm purchase orders not later than three (3) months prior
to the desired delivery date.
For
purchase orders less than or equal to nine (9) kilograms, the minimum quantity
in such purchase order shall not be less than three (3)
kilograms. For quantities from ten (10) kilograms up to and including
one hundred (100) kilograms, the minimum quantity in such purchase order shall
not be less than ten (10) kilograms and multiples of ten (10)
thereafter. For quantities greater than one hundred (100) kilograms,
Generex shall order full batches. Under no circumstances shall SAD be
obliged to accept purchase orders or deliver the Active Ingredient pursuant
thereto in quantities smaller than the minimum order quantities set out
above.
6.2 Confirmation by SAD;
Order
Confirmation. No later than fifteen (15) business days after
receipt of Generex’s purchase orders, SAD shall confirm that it can fulfill the
monthly quantities specified in such orders, and shall confirm for each relevant
portion of such monthly quantities the expected delivery date within the month
specified.
6.3 Additional
Quantities. If the purchase order quantities are in
excess of the Forecast quantities by more than twenty five percent (25%), then
SAD shall use commercially reasonable efforts to manufacture and supply the
excess quantities up to [REDACTED],
with the express understanding that any failure or delay in the delivery of such
excess amounts shall not subject SAD to any penalties or other
liabilities. Unless otherwise agreed to by SAD before such orders
[REDACTED]
were placed, SAD, at its sole discretion, may elect whether or not to
manufacture and supply the excess quantities [REDACTED]
for such orders, subject to the terms set out in Section 2.4 above and otherwise
set forth in this Agreement.
6.4 Long-Term Planning
Forecasts. Within one month after the first day of each
Contract Year (Y), Generex will supply SAD with a written four (4) year
non-binding rolling forecast reflecting Generex’s projected annual Active
Ingredient demand for the four (4) Contract Years (Y+1) to (Y+4) following the
Contract Year in which such planning forecast is provided to SAD. Such planning
forecasts shall represent Generex’s most current estimates for planning purposes
only, and shall not be considered to be purchase commitments.
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ARTICLE
7
REGISTRATION OF THE
PRODUCT
7.1 General. Generex
shall diligently use good faith commercially reasonable efforts to receive
necessary governmental approvals which allow the sale of Product in all
territories which comprise the Territory for the Product.
7.2 Cooperation of the
Parties. The Parties shall diligently cooperate in good faith
to conduct the registration activities required for Product Approval (such
Product containing SAD provided Active Ingredient) approval by the regulatory
agencies in the countries in the Territory or any countries the Parties
contemplate adding to the Territory for the Product containing the Active
Ingredient, which costs (i.e.; registration fees) shall be paid solely by
Generex. For this purpose, SAD will provide Generex with a letter of reference
to its Drug Master File in respect of the Active Ingredient as submitted to the
FDA and other relevant governmental regulatory authorities for the
Term. In addition, SAD shall provide the specific regulatory
agency within a particular territory with a copy of open parts of the Drug
Master Files with respect to the Active Ingredient, as submitted to the
regulatory agencies of the respective territories comprising the
Territory. For clarification, under no circumstance is SAD required
to provide any information, data, or other material which SAD, in good faith and
at SAD’s sole discretion, determines is proprietary or deemed to be the closed
parts of the Drug Master File, and by not providing such information, data or
other materials, SAD is not in violation of the terms outlined herein and in
this Agreement; provided, however, that in the event that Generex is unable
to procure Product approval in any territory in the Territory as a consequence
of SAD’s failure to provide such information, data or other materials related to
the Active Ingredient, then this Agreement shall be deemed to be amended by
deleting such territory (and, by extension, any Minimum Purchase Commitments in
respect of such territory) from Exhibit 1 or Exhibit 1A annexed hereto (such
that such territory will no longer be included in the Territory).
ARTICLE
8
DELIVERIES;
INSPECTIONS
8.1 Purchase Quantities.
SAD will use commercially reasonably efforts to ship the quantities specified in
a particular monthly purchase order. Should it be anticipated that
there will be a quantity variation (between what is available for shipment and
what is outlined in a purchase order) above or below five percent (5%), the
parties shall negotiate in good faith on the actual quantity to be
shipped. Variations in shipments as outlined herein shall be deemed
to be in compliance with such purchase order; provided, however, that Generex
shall only be invoiced and required to pay for the quantities of Active
Ingredient which SAD actually ships to Generex. It is understood and
accepted by Generex that quantities shipped are subject to the Packaging
Specifications set out in Exhibit 3 hereto.
8.2 Active Ingredient
Release. No Active Ingredient shall be released to Generex
without a Certificate of Analysis and Certificate of GMP Compliance, both of
which shall be supplied to Generex by SAD. SAD shall conduct such
quality assurance testing for the Active Ingredient as is required by the
Specifications, cGMPs and the Quality Agreement. SAD shall conduct in
parallel on-going stability studies of the Active Ingredients.
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8.3 Delivery Terms.
Shipment of the Active Ingredient will be to one location as designated by
Generex. Generex 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
Generex. All shipments of the Active Ingredient to Generex shall be
made via such carrier(s) as Generex may direct. Title and risk of
loss shall pass to Generex upon delivery to the carrier. Freight
charges shall be billed ship collect.
8.4 Shipping; Dating and Customs
Costs. SAD shall make commercially reasonable efforts to cause
Active Ingredient delivered hereunder to have eighteen (18) 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 Generex.
8.5 Inconsistencies. In
the event of any inconsistencies between the terms of this Agreement and any
purchase order issued by Generex hereunder or any acceptance thereof by SAD, the
terms of this Agreement shall govern.
8.6 Inspections by
Generex. Upon reasonable prior written notice, the single
Generex designated agent which is reasonably agreed to by SAD, together with up
to two (2) Generex employees, 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,
Generex agrees to not inspect a Production Site more often than one (1) time in
three (3) calendar years.
8.7 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 for a particular territory listed in
Exhibit 1 or 1A, SAD shall promptly inform Generex of such inspection and shall
cooperate with and allow such inspection to the extent required by applicable
laws. Generex 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 Generex resulting from such inspection to the extent relevant to the
Active Ingredient. SAD will promptly inform Generex whether any Form
FDA 483 or warning letters or citations are issued to SAD (by the FDA or any
other governmental authority for a particular territory listed in Exhibit 1 or
Exhibit 1A) which are related to or impact the supply of the Active
Ingredient.
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ARTICLE
9
PRICE; PRICE ADJUSTMENTS;
PAYMENT TERMS
9.1 Price. The
per-kilogram price(s) payable by Generex for all quantities of the Active
Ingredient ordered hereunder (the “Active Ingredient
Price(s)”) shall be as specified in the pricing schedule in Exhibit 2 hereto; as
such prices may be revised from time to time pursuant to Article 5 and Article
9.
9.2 Price Adjustments.
The Active Ingredient Price through December 31, 2012 shall be
as specified in the pricing schedule in Exhibit 2 attached
hereto. Subject to Article 5 hereof, the Active Ingredient Price(s)
listed in Exhibit 2 for each Contract Year thereafter shall be equal to the
Active Ingredient Price(s) in effect at the end of the immediately preceding
Contract Year, increased (or decreased, as the case may be) by a percentage
equal to fifty percent (50%) of the percentage increase (or the decrease, as the
case may be) in the Producer Price Index of the Federal Republic of Germany (the
“PPI”) over the course of the immediately preceding Contract Year, calculated as
the average of the twelve (12) monthly PPI data reports of the Federal
Statistical Office Germany during the immediately preceding Contract
Year.
9.3 Payment Terms. SAD
shall invoice Generex for all quantities of the Active Ingredient purchased
hereunder concurrently with SAD’s shipment thereof to Generex. Subject to
Section 13.1, and Section 8.3, all amounts properly invoiced by SAD hereunder
shall be due and payable [REDACTED]
days from the date of such invoice, except that for the first two Contract Years
(for the Minimum Purchase Commitments only and payment thereof in 2009 and
2010), Generex shall submit payment within [REDACTED]
days from the date of invoice. SAD shall deliver invoices to Generex
on the date the invoice is issued. Payment may be made by Generex’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 Generex shall be responsible for payment for such actual quantities
shipped in accordance with this Agreement and the Packaging Specifications set
out in Exhibit 3 hereto.
ARTICLE
10
SAD’S REPRESENTATIONS,
WARRANTIES AND COVENANTS
SAD
represents, warrants and covenants to Generex as follows:
10.1 Active Ingredient.
The Active Ingredient, at the time of sale and shipment to Generex 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 8.4
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.
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10.2 Manufacturing
Standards. SAD shall manufacture the Active Ingredient in accordance with
(i) the Specifications, (ii) then-current cGMPs, and (iii) applicable ICH
Guidelines.
10.3 Compliance with Applicable Laws. SAD
shall fully comply with all applicable federal, state and local laws in the
Territory, as they relate to the manufacture or sale of pharmaceutical products,
in performing the services contemplated hereunder.
10.4 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.
10.5 SAD
represents and warrant to Generex that the Facility 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
11
GENERAL REPRESENTATIONS AND
WARRANTIES
Each
Party represents and warrants to the other as follows:
11.1 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.
11.2 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.
11.3 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.
11.4 Debarment. As
of the Effective Date, neither party has been debarred under FDCA 21 USC 335a,
and to the best of its knowledge, is not subject to pending debarment under FDCA
21 USC 335a.
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ARTICLE
12
TERM;
TERMINATION
12.1 Term. Unless sooner
terminated pursuant to the terms hereof, the term of this Agreement shall
commence on the Effective Date and shall expire on October 31, 2016 (the
“Initial Term”). Upon the expiration of the Initial Term, this Agreement shall
automatically and continually renew for successive three (3) year terms (each, a
“Renewal Term”, and the Initial Term and all Renewal Terms being collectively
referred to as the “Term”) unless either Party notifies the other in writing at
least twenty-four (24) months prior to the end of the Initial Term or any
Renewal Term, as the case may be, of its intent that this Agreement shall
expire without further renewal.
12.2 Third Party
Distribution. In the event that Generex (a) executes and
delivers an agreement with a Third Party pursuant to which the Third Party
agrees to distribute the Product in one or more territories listed in Exhibit 1
(each a “Third Party Distribution Jurisdiction”), and (b) the business of such
Third Party includes the manufacture of recombinant human insulin, then, upon
not less than thirty (30) days’ prior written notice by Generex to SAD, this
Agreement shall be deemed to be amended by deleting the Third Party Distribution
Jurisdiction (and, by extension, any Minimum Purchase Commitments in respect of
such Third Party Distribution Jurisdiction) from Exhibit 1 annexed hereto (such
that the Third Party Distribution Jurisdiction will no longer be included in the
Territory for Exhibit 1), and at the sole option of SAD, to move such Third
Party Distribution Jurisdiction to Exhibit 1A or remove from the Agreement in
its entirety.
12.3 Termination by Generex for
Utility Loss. Generex
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 Generex in accordance with this Section 12.3 and Article 5,
Generex’s then-current obligations under this Agreement 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.
12.4 Termination For Low
Volume. This Agreement may be terminated by SAD in its sole
discretion after December 31, 2011, upon not less than twelve (12) months’ prior
written notice in the event that the forecasted purchase volumes of Generex for
Active Ingredient pursuant to Section 6.1 hereof for the next two (2) calendar
quarters (Q+1 though Q+2) is less than ten (10) kilograms (“Low
Volume”). The parties acknowledge and agree that they shall have good
faith discussions regarding Low Volume issues prior to any SAD termination in
accordance with this Section 12.4, but that SAD retains the right to terminate
as set forth above. Within six (6) months of Generex receiving SAD’s written
termination notice in accordance with this Section 12.4, Generex shall have the
option to request, and the parties shall then have, a second good faith
discussion regarding Low Volume, subject to SAD having the ultimate right to
have the termination become effective as set out herein.
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12.5 Termination Upon Delay of
Commercialization. Should the project of commercializing the
Product be delayed beyond December 31, 2011 in any particular territory in the
Territory, then, at SAD’s discretion and upon not less than thirty (30) days’
prior written notice by SAD to Generex, this Agreement shall be deemed to
be amended by deleting such territory (and, by extension, any Minimum
Purchase Commitments in respect of such territory) from Exhibit 1 or Exhibit 1A
annexed hereto (such that such territory will no longer be included in the
Territory).
12.6 Termination For Failure of Bridging Study
or In-Vitro Physio-Chemical Characterizations (each a “Study”). Generex
acknowledges and agrees that Generex is obligated to perform a Study if required
by a regulatory authority in any territory as listed in Exhibit 1 or 1A at
Generex’s sole cost and expense. Either party shall have the right to
terminate this Agreement without further obligation if (a) a Study is conducted
involving not less than fifty (50) patients and that Study does not demonstrate
non-inferiority of Product utilizing the Active Ingredient supplied by SAD, or
(b) any in-vitro physio-chemical characterizations (as outlined in Exhibit 6)
carried out on the Active Ingredient supplied by SAD cannot be used to establish
suitable equivalence to the recombinant human insulin product supplied by N.V.
Organon and utilized in the Product prior to the date hereof. Generex
shall promptly communicate the results of any completed Study and/or
characterizations to SAD. SAD shall have the right, at its sole
expense, to audit and receive for review any documentation or information
related to a Study and/or characterizations in order to verify that the same
were conducted in accordance with industry practice. The termination
right under this Section 12.6 must be exercised within sixty (60) days of
the date the results of a Study and/or characterizations are available to
Generex.
12.7 Termination by Mutual
Agreement. The Parties may terminate this Agreement at any time by mutual
written agreement.
12.8 Termination Upon Breach. Either Party
may terminate this Agreement upon not less than ninety (90) 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, not exceeding six (6) months, upon the
breaching Party’s written certification that (i) such breach is not reasonably
capable of being cured within such ninety (90) 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.
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12.9 Rights and Duties Upon
Termination.
(a) Unless
otherwise mutually agreed by the Parties, SAD shall manufacture and ship, and
Generex shall purchase in accordance with the provisions hereof, all quantities
of Active Ingredient ordered by Generex hereunder prior to the date of
expiration or termination
(b) Upon
the expiration or termination of this Agreement (other than termination by
Generex pursuant to Section 12.3 or Section 12.8 hereof), Generex 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 or Minimum Purchase Commitments, at SAD’s Acquisition Cost
thereof, (ii) all work-in-progress of the Active Ingredient in respect of the
then-current Forecast or Minimum Purchase Commitments at SAD’s actual cost
thereof, and (iii) all finished Active Ingredient inventory in respect of the
then-current Forecast or Minimum Purchase Commitments, then in SAD’s possession
at the then-current Active Ingredient Price hereunder. In addition, in such case
Generex shall pay SAD for any uncancellable commitments made by SAD for
materials and components made by SAD hereunder in respect of the then-current
Forecast or Minimum Purchase Commitments. Notwithstanding anything to
the contrary in the preceding two sentences, the foregoing purchase and payment
obligations of Generex shall be limited solely to materials and components
obtained as to the time periods for the types of materials and components
provided in Section 5, and Active Ingredient quantities manufactured as to which
Generex’ forecasts under Section 6.1 hereof constitute a firm
commitment.
ARTICLE
13
CLAIMS;
RECALLS
13.1 Claims. Generex may
reject any quantity of the Active Ingredient which fails to conform to any
applicable purchase order, warranty, or Specifications upon written notice to
SAD describing such nonconformity given within thirty (30) days after Generex’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 Generex). SAD shall have no liability to Generex
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 Generex or due to a fault
in materials supplied by Generex, (ii) was otherwise caused by Generex 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
Generex’s account for SAD’s invoice price to Generex of such nonconforming
Active Ingredient. Additionally, if Generex shall have previously
paid for such nonconforming Active Ingredient, SAD shall promptly, at Generex’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 Generex. 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.
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13.2 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
authorities 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. Generex
shall institute a Recall of the Product as a consequence of any defect that
Generex deems sufficiently serious. Generex shall consult with SAD regarding any
Recall of Product which was manufactured using Active Ingredient supplied by SAD
hereunder; provided, however, that Generex
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 Generex 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 Generex, (ii) was otherwise caused by Generex or its agents, (iii)
was caused by factors occurring after delivery of the Active Ingredient to the
carrier at the Production Site, or (iv) did not result from a breach of SAD’s
warranties provided under Article 10 hereof. In addition, Generex
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 16.2
hereof). 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 this Section 13.2(c), SAD shall: (x) promptly credit Generex’s
account for SAD’s invoice price to Generex of the Active Ingredient used in such
Recalled Product; if Generex shall have previously paid for such Active
Ingredient, SAD shall promptly, at Generex’ 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 Generex (y) reimburse Generex, subject to the limitation set out in
subsection 13.2(e) below, for all reasonable out-of-pocket Third Party costs and
expenses incurred and not recovered by Generex directly resulting from such
Recall (subject to the limitations set forth in Section 16 hereof).
(d) Independent Laboratory
Costs. The fees and expenses of any independent laboratory or
consultant engaged by the Parties for purposes of this Section 13.2 shall be
paid by the Party which is determined to bear responsibility for the Recall in
question.
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(e) Limitation. Notwithstanding
any other provision of this Agreement, the liability of SAD to reimburse Generex
for Third Party costs and expenses pursuant to Section 13.2(c)(y) hereof related
to any Recall shall not exceed [REDACTED]
($[REDACTED])
dollars plus fifty percent (50%) remaining liability up to [REDACTED]
dollars ($[REDACTED])
in respect of each such Recall. For clarification, SAD shall
have a maximum per recall liability of [REDACTED]
($[REDACTED])
dollars. 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 Generex pursuant to this Section 13.2.
13.3 Disposition of Nonconforming
or Recalled Product. Generex 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 Generex 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 13.1 or 13.2 hereof.
ARTICLE
14
INDEMNIFICATION
14.1 By Generex. Generex
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 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) Generex’s use, handling, distribution, marketing or sale of
the Active Ingredient (subject to Section 14.2 hereof) or the Product, (b) the
breach by Generex of any of its representations, warranties, covenants,
obligations, agreements or duties under this Agreement (c) any claim that the
manufacture, use or sale of the Product (which for purposes of this section,
includes Active Ingredient) infringes a patent or any other proprietary rights,
or (d) any other claim that arises from and is related to the Product; 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. It
is understood that for purposes of this Section 14.1, and as related to Third
Party Claims as defined above, “Generex” shall include
Generex Affiliates.
14.2 By SAD. SAD shall
defend, indemnify and hold harmless Generex, 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 Generex or the breach by Generex of any of its representations,
warranties, covenants, obligations, agreements or duties under this
Agreement.
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14.3 Procedure. Promptly
after learning of the occurrence of any event which may give rise to its rights
under the provisions of this Article 14, 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 be in charge of and control such negotiations,
compromise and defense and shall 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
15
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
16
LIMITATION OF
LIABILITY
16.1 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 PARTY.
16.2 DAMAGES. SAD SHALL
NOT 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).
16.3 Remedies. SAD’s
sole obligations, and Generex’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 13.1 and 13.2 hereof,
respectively.
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16.4 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 HIGHEST AGGREGATE AMOUNTS PAID TO SAD
HEREUNDER DURING ANY TWELVE (12) MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO
LIABILITY, BUT IN NO EVENT SHALL SAD’S LIABILITY EXCEED FIVE MILLION
($5,000,000.00) DOLLARS, IN THE AGGREGATE OVER THE ENTIRE TERM.
ARTICLE
17
CONFIDENTIALITY
17.1 Treatment of Confidential
Information. Except as otherwise provided in this Article 17, during the
Term and for a period of ten (10) years thereafter:
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(i)
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SAD
will retain in confidence and use only for the purposes contemplated
hereby any Confidential Information disclosed to it by or on behalf of
Generex in connection with the performance of this Agreement;
and
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(ii)
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Generex
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.
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17.2 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.
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ARTICLE
18
OWNERSHIP OF
PROPERTY
18.1 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.
18.2 Trademarks. Generex
shall retain all right, title and interest arising under the U.S. Trademark Act
and all other applicable laws in the trademarks of Generex that may be adopted
with respect to the Product.
ARTICLE
19
Intentionally
omitted.
ARTICLE
20
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, 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 Generex is required to submit or which Generex 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) Generex 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
21
FORCE
MAJEURE
21.1 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.
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21.2 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.
21.3 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
22
INDEPENDENT
CONTRACTORS
The relationship between Generex 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 Generex 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
23
FURTHER
ACTIONS
General. The Parties
agree to execute such additional documents and to perform all such other and
further acts as may be necessary or desirable to carry out the purposes and
intents of this Agreement.
ARTICLE
24
MISCELLANEOUS
24.1 General Notices.
Except as otherwise provided in Section 24.2 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:
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MANUFACTURING
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21
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If to
Generex:
Generex
Biotechnology Corporation
00
Xxxxxxx Xxxxxx, Xxxxx 000,
Xxxxxxx,
Xxxxxxx, Xxxxxx X0X 0X0
|
Attention:
|
Xxxx
X. Xxxxx,
|
Chief
Operating Officer
|
FAX:
|
0-000-000-0000
|
If to SAD:
Sanofi-Aventis
Deutschland GmbH
Xxxxxxxxxxxxx
Xxxxxxx, 00000
Xxxxxxxxx xx Xxxx, Xxxxxxx
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.
24.2 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
24.1 to the attention of the following personnel:
If to Generex:
Technical complaints: Xxxxxx Xxxxxx,
Vice-President, Regulatory Affairs
Adverse
reactions: Xxxxxx Xxxxxx, Vice-President,
Regulatory Affairs
If to SAD:
Technical complaints: Site Quality
Manager
Adverse reactions:
Site Quality Manager
24.3 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.
24.4 Amendment. No
amendment of this Agreement shall be effective unless embodied in a written
instrument executed by both of the Parties.
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24.5 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.
24.6 Subcontracting. 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 24.7 hereof.
24.7 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. Should SAD consent to an assignment by Generex to another party,
Generex shall assign its rights and delegate its duties under this Agreement in
whole or in part to such party, and shall ensure that such party (A) undertakes
in writing with SAD to observe and perform the obligations of Generex hereunder
and under the Quality Agreement, (B) has adequate financial resources (equal or
superior to Generex’s financial resources as of the date of the assignment) to
perform Generex’s financial obligations hereunder, and (C) meets with SAD to
review the future of manufacturing for the Active
Ingredient. Notwithstanding the foregoing, SAD may assign this
Agreement to an Affiliate.
24.8 Governing Law. This
Agreement shall be governed by and construed in accordance with the laws of New
York without regard to its conflicts of laws principles.
24.9 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.
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24.10 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. Neither party will issue any press release
or otherwise make any public statement, advertisement or disclosure
with respect to this Agreement or Products which contain SAD Active
Ingredient or the transactions contemplated hereby without the prior written
consent of the other Party, which shall not be unreasonably withheld; provided,
however, if, in the opinion of the disclosing Party’s legal counsel, such
announcement is necessary to comply with applicable law, either Party shall be
entitled to make a public announcement of this Agreement and/or file a Form 8-K
Current Report with the Securities and Exchange Commission, subject to the prior
review and approval of such press release and/or Form 8-K by the other Party,
which approval will not be unreasonably withheld or delayed and provided to the
extent practicable the other Party has received at least three (3)
business days notice. Mutually agreed upon redacted versions of
this Agreement may be exhibits to the Form 8-K Current Report. In
addition, Generex will be entitled to make reference to this Agreement in
reports filed with the Securities and Exchange Commission, after providing
SAD advance and a reasonable opportunity to review and comment
thereon.
24.11 Survival. The
provisions of 12.9 (Rights and Duties Upon Termination), Article 13 (Claims;
Recalls), Article 14 (Indemnification), Article 15 (Insurance), Article 16
(Limitation of Liability), Article 17 (Confidentiality), Article 18 (Ownership
of Property), Article 20 (Cooperation with Governmental Requirements), Section
24.8 (Governing Law), Section 24.10 (Publicity) and Section 24.11 (Survival)
shall survive the expiration or termination of this Agreement.
24.12 Headings. The
headings of articles and sections have been included for convenience only and
shall not be considered in interpreting this Agreement.
24.13 Counterparts. 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 electronic
facsimile transmission with the same force and effect as if it were executed and
delivered by the Parties simultaneously in the presence of one
another.
24.14 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.
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IN WITNESS WHEREOF, the Parties have
caused this Agreement to be executed by their respective duly authorized
representatives as of the day and year first above written.
|
Generex
Biotechnology Corporation
|
||
|
By:
|
/s/ Xxxx X. Xxxxxxx
|
|
|
Name:
|
Xxxx
X. Xxxxxxx
|
|
|
Title:
|
President,
Chief Executive Officer
|
|
|
By:
|
/s/ Xxxx X. Xxxxx
|
|
|
Name:
|
Xxxx
X. Xxxxx
|
|
|
Title:
|
Chief
Operating Officer, Chief Financial Officer
|
|
|
SANOFI-AVENTIS
DEUTSCHLAND GMBH
|
||
|
By:
|
/s/ X. Xxxxx
|
|
|
Name:
|
X. Xxxxx
|
|
|
Title:
|
Vice President
|
|
|
SANOFI-AVENTIS
DEUTSCHLAND GMBH
|
||
|
By:
|
/s/ Xxxxx Xxxxxx
|
|
|
Name:
|
Xx. Xxxxx Xxxxxx
|
|
|
Title:
|
CFO Germany
|
|
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25
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Exhibit
1
TERRITORIES: EXCLUSIVE
Territories
where Generex will register Generex Oral-xxx
with the
Active Ingredient to be supplied by SAD on an exclusive basis
[REDACTED]
Exhibit
1A
TERRITORIES: NON-EXCLUSIVE
Territories
where Generex will register Generex Oral-xxx
with the
Active Ingredient to be supplied by SAD on a non-exclusive basis
[REDACTED]
Exhibit
2
ACTIVE INGREDIENT
PRICES
The
Active Ingredient Prices payable by Generex to SAD through December 31, 2012
will be as follows:
|
a.
For the first [REDACTED]
kg:
|
[REDACTED]
€ per gram;
|
|
b.
for the succeeding [REDACTED]
kg:
|
[REDACTED]
€ per gram; and
|
|
c.
thereafter:
|
[REDACTED]
€ per
gram.
|
Such
pricing (in Euros) is subject to adjustment pursuant to Articles 5 and 9 of the
Agreement. In addition, the above pricing includes packaging in
compliant bulk containers and on-going routine stability testing costs, and is
exclusive of all taxes, tariffs and customs duties.
* * * *
*
Exhibit
3
PACKAGING
SPECIFICATIONS
SAD will
supply the Active Ingredient in packaging units of two (2) to three (3)
kilograms for a purchased quantity below ten (10) kg and in packaging units of
eight (8) to eleven (11) kilograms (standard preferred packaging unit) for a
purchased quantity higher than ten (10) kilograms.
The
following sizes of [REDACTED]
drums are utilized for packaging and delivery:
1. [REDACTED]
drum - height*:[REDACTED]mm
+/- [REDACTED]mm;
Inside diameter: [REDACTED]mm
+/- [REDACTED]
mm, for [REDACTED]
kg consignments.
2. [REDACTED]
drum - height*: [REDACTED]mm
+/- [REDACTED]mm,
Inside diameter: [REDACTED]mm
+/- [REDACTED]mm,
for [REDACTED]kg
of content (this drum is the standard pack).
*
not factoring in the lid
SAD shall
have the right, at its option, to deliver ordered quantities in one drum where
feasible.
Exhibit
4
ACTIVE
INGREDIENT SPECIFICATIONS
[REDACTED]
Exhibit
5
MINIMUM PURCHASE
COMMITMENTS
Generex
shall purchase from SAD a minimum of [REDACTED]
kilograms of Active Ingredient prior to December 31, 2011 as set forth
below:.
Minimum
quantity for the first three years of the agreement:
1.
Contract
Year 1 (Effective Date through December 31, 2009):
[REDACTED]
kg
2.
Contract
Year 2 (January 1, 2010 through December 31, 2010):
[REDACTED]
kg
3.
Contract
Year 3 (January 1, 2011 through December 31, 2011):
[REDACTED]
kg
* * * *
*
Exhibit
6
IN-VITRO PHYSIO-CHEMICAL
CHARACTERIZATIONS
In-Vitro
Physio-Chemical Characterizations are determined using the following analytical
methods:
- X-ray
crystallography
-
SDS-PAGE
-
Mass-spectrometry
-
FT-IR
- Loss on
drying
-
Impurity Profile (HPLC testing only)
Scientific
comparisons from the results of these analytical techniques will be made to
determine characterization equivalence between the SAD Active Ingredient and the
third party supplying the active ingredient to Generex.. The
characterization limits associated with loss on drying and impurity profile
listed above are defined by USP and EU Pharmacopoeia set forth in Exhibit
4.
