MANUFACTURING LICENSE
AGREEMENT
This Manufacturing License Agreement (the
“Agreement”) is made and entered into as of this 13th
day of August, 2009 by and between InnoZen, Inc., a Delaware
corporation with offices at 6429 Independence Avenue, Woodland
Hills, California (“InnoZen”) and Supplemental
Manufacturing & Ingredients, LLC., dba SMI Manufacturing, an
Arizona limited liability company with offices at 2401 West 1st
Street, Tempe, Arizona (“SMI”).
WHEREAS , InnoZen has experience in the formulation,
development, manufacturing, distribution and sale of edible thin
film-strips containing dietary supplement, nutraceutical, and drug
active ingredients;
WHEREAS , SMI has begun and desires to design, build and
operate a state-of-the-art, cGMP, edible film-strip manufacturing
facility in Arizona.
WHEREAS , SMI desires to manufacture InnoZen’s
edible film-strip products in its Arizona facility.
NOW ,
THEREFORE , in consideration of the mutual covenants and
promises contained in this Agreement and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, InnoZen and SMI agree as follows:
As used in this Agreement, the following terms,
whether used in the singular or plural, shall have the following
meanings:
1.1. “Affiliate” shall mean
any company or other business entity controlled by, controlling or
under common control with a party, control being presumed if there
is direct or indirect ownership of at least 35% (or, if less, the
maximum permitted by applicable law) of the voting stock, equity or
income interest.
1.2. “Change of Control
Transaction” shall mean a transaction (i) in which a
Party sells ownership of 50% or more of all of its classes of
voting securities or ownership interests to a single investor or
group of related investors, or (ii) in which a Party sells all
or substantially all of its assets.
1.3. “Cost” shall mean the
actual cost of goods sold associated with the manufacture of a
particular Product based on generally accepted accounting
principles.
1.4.
“FDA” shall mean the United States Food and Drug
Administration (or a successor agency).
1.5.
“Field” shall mean the sale of the Products to
InnoZen or its Affiliates.
1.6. “Force Majeure” shall
mean a failure to fulfill a requirement under this Agreement due to
fire, flood, strike or other labor dispute, accident to machinery,
act of sabotage, riot, precedence or priority granted at the
request of or for the benefit, directly or indirectly, of any
government, including but not limited to the United States of
America federal or state, or a Territory, foreign government or any
subdivision or agency thereof, export. or import restriction, delay
in transportation or lack of transportation, facilities,
restriction imposed by United States of America federal or state or
a Territory, foreign legislation or rule or regulation there under,
or war or insurrection or any cause beyond the control of either
party.
1.7. “GMP” shall mean current
good manufacturing practices as defined under FDA and other
regulatory authority rules and regulations and that are applicable
to the manufacture of the Products.
1.8. “Licensed Technology”
shall mean (i) all Patent Rights, (ii) all intellectual
property, derivatives, know-how, trade secrets, processes and data,
including, but not limited to, formulations, manufacturing
procedures, and specifications owned or possessed by InnoZen as of
the date of this Agreement relating to the Manufacture and
commercialization of the Products but only to the extent such
information and data is necessary to commercially exploit the
Products in the Field.
1.9. “Manufacture” shall mean
the production and making of the Products by labor and machinery,
but shall not include any making or production of the Products
related to research and development activities or
functions.
1.10.
“Party” shall mean SMI or InnoZen;
“Parties” shall mean SMI and InnoZen.
1.11. “Patent Applications”
shall mean [***].
1.12. “Patent Rights” shall
mean all rights arising in connection with the Patent Applications,
and any patents ultimately issued in connection
therewith.
1.13. “Product” or
“Products” shall mean any commercial, edible
film-strip product that utilizes the Patent Rights or Licensed
Technology.
II.
MANUFACTURING LICENSE
2.1. License. Subject to (i) the
termination provisions set forth in Section 2.3 herein, (ii)
the reservation of rights set forth in Section 2.4 herein, and
(iii) the other terms of this Agreement, InnoZen hereby grants
to SMI a non-exclusive license in and to the Patent Rights and the
Licensed Technology to Manufacture the Products in the Territory
for the Field and other customers authorized in writing by
InnoZen.
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Confidential treatment requested as
to certain portions of this exhibit. Such portions have been
redacted and filed separately with the SEC.
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2.2. Term of License. The non-exclusive
license granted in Section 2.1 herein shall be for a term of
twelve (12) years, unless terminated earlier under the terms
of this Agreement. In addition, upon mutual agreement of the
Parties, the Agreement may be extended for an additional twelve
(12) year term.
2.3.
Termination of License.
(a) SMI shall provide to InnoZen a
quarterly report relating to its GMP status and to its federal,
state, and local regulatory certification and authorization. In the
event that SMI loses its GMP status or its certification or
authorization under any federal, state or local regulatory
authority, and after written notice thereof is provided by InnoZen,
then, in addition to all other rights and remedies under this
Agreement and otherwise available at law, InnoZen shall have the
right, at its option, to temporarily suspend or terminate the
license granted in Section 2.1 whereupon such license shall be
temporarily suspended or terminated. If SMI is unable to regain its
GMP status or its regulatory certification or authorization for a
period of sixty (60) days after written notice thereof is
provided by InnoZen, then, all rights granted to SMI by InnoZen
under this Agreement (including without limitation all Patent
Rights and Product and Licensed Technology rights) shall terminate,
become null and void, and shall revert in their entirety to
InnoZen, and InnoZen may, in its sole option, terminate this
Agreement in its entirety.
(b) In the event SMI materially breaches or
fails to perform any provision of this Agreement and such material
breach or failure continues for a period of thirty (30) days
after written notice thereof is provided by InnoZen, then, in
addition to all other rights and remedies under this Agreement and
otherwise available at law, InnoZen shall have the right, at its
option, to temporarily suspend or terminate the license granted in
Section 2.1 whereupon such license shall be temporarily
suspended or terminated. If there occurs any other or additional
material breach or failure of SMI to perform its duties under this
Agreement within six (6) months after the date of the initial
material breach or failure to perform (excluding any cure period)
or at any time thereafter if the initial material breach or failure
to perform remains uncured, all rights granted to SMI by InnoZen
under this Agreement (including without limitation all Patent
Rights and Product and Licensed Technology rights) shall terminate,
become null and void, and shall revert in their entirety to
InnoZen, and InnoZen may, in its sole discretion, terminate this
Agreement in its entirety.
2.4. Reservation of Rights. InnoZen
retains all rights in and to the Products, the Patent Rights and
all of the Licensed Technology not specifically granted in
Section 2.1.herein. Consequently, in addition to other rights
that SMI shall not have, SMI shall not have the right to use,
distribute, offer for sale, or sell the Products to any entity
other than InnoZen or those InnoZen designees approved and
appointed by InnoZen in writing.
2.5. Reversion. Upon termination of this
Agreement, SMI shall return and deliver to InnoZen the Patent
Rights, the Licensed Technology and all other information relating
to the grant of the license rights in Section 2.1,
herein.
III.
MANUFACTURING / SUPPLY
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Confidential treatment requested as
to certain portions of this exhibit. Such portions have been
redacted and filed separately with the SEC.
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3.3. Exclusive Manufacturing — Right of
First Refusal. Subject to (i) the terms set forth in
Section 3.4 herein, (ii) the termination provisions set
forth in Section 3.5 herein, and (iii) the other terms of
this Agreement, SMI shall have the first right to exclusively
negotiate with InnoZen for the Manufacture of the Products in the
Territory for the Field (the “Right of First
Refusal”).
3.4. Exercise of Right of First Refusal.
The Right of First Refusal shall operate on a Product-by-Product
basis, and SMI shall exercise the Right of First Refusal for each
Product separately. InnoZen shall notify SMI in writing of its
intent to commercially exploit a particular Product [***]. SMI
shall then have ten (10) days from receipt of such
notification in which to exercise the Right of First Refusal for
such Product and shall inform InnoZen in writing of its decision to
exercise the Right of First Refusal for such Product. Upon
SMI’s notification of its decision to exercise the Right of
First Refusal for such Product, the Parties shall immediately begin
good faith negotiations for the Manufacture of such Product under a
separate Manufacturing Agreement as provided in Section 3.6
herein.
3.5.
Termination of Right of First Refusal.
(a) In the event that SMI (i) refuses
to manufacture a particular Product, (ii) fails to fulfill a
purchase order for a particular Product, or (iii) is unable to
meet all product specifications, capacity requirements, quality
requirements, manufacturing requirements, reasonable customer
requirements, or regulatory requirements related to a particular
Product and such refusal, failure or inability continues for a
period of thirty (30) days after written notice thereof is
provided by InnoZen, then, in addition to all other rights and
remedies under this Agreement and otherwise available at law,
InnoZen shall have the right, at its option, to revoke and
terminate the Right of First Refusal for that particular Product
and the Right of First Refusal for that particular Product shall be
null and void. In such event, and without limiting any other
InnoZen rights and remedies, InnoZen shall have the right to grant
to any person(s) or entity(ies) the right and license to
manufacture the particular Product and to do the foregoing itself.
This Section 3.5(a) shall apply and be enforceable at all
times during the term of this Agreement including both prior to
SMI’s exercise of the Right of First Refusal for the
particular Product and after the exercise of such Right of First
Refusal for the particular Product.
(b) SMI shall provide to InnoZen a
quarterly report relating to its GMP status and to its federal,
state, and local regulatory certification and authorization. In the
event that SMI loses its GMP status or its certification or
authorization under any federal, state or local regulatory
authority, and after written notice thereof is provided by InnoZen
then, in addition to all other rights and remedies under this
Agreement and otherwise available at law, InnoZen shall have the
right, at its option, to revoke and terminate the Right of First
Refusal for all Products and the Right of First Refusal for all
Products shall be null and void until such time as SMI is able to
regain its GMP status or its regulatory certification or
authorization. In such event, and without limiting any other
InnoZen rights and remedies, InnoZen shall have the right to grant
to any person(s) or entity(ies) the right and license to
manufacture the Products and to do the foregoing itself. If
SMI’s failure to maintain its GMP status or its regulatory
certification or authorization remains uncured for a period of
sixty (60) days after written notice thereof is provided by
InnoZen, then, all rights granted to SMI by InnoZen under this
Agreement (including without limitation all Right of First Refusal
rights, Patent Rights and Product and Licensed Technology rights)
shall terminate, become null and void, and shall revert in their
entirety to InnoZen, and InnoZen may, in its sole option, terminate
this Agreement in its entirety. This Section 3.5(b) shall
apply and be enforceable at all times during the term of this
Agreement including both prior to SMI’s exercise of the Right
of First Refusal for any Products and after the exercise of such
Right of First Refusal for any Products.
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Confidential treatment requested as
to certain portions of this exhibit. Such portions have been
redacted and filed separately with the SEC.
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(c) In the event SMI materially breaches or
fails to perform any provision of this Agreement and such material
breach or failure continues for a period of thirty (30) days
after written notice thereof is provided by InnoZen, then, in
addition to all other rights and remedies under this Agreement and
otherwise available at law, InnoZen shall have the right, at its
option, to revoke and terminate the Right of First Refusal for all
Products and the Right of First Refusal for all Products shall be
null and void until such time as SMI is able to cure such breach.
In such event, and without limiting any other InnoZen rights and
remedies, InnoZen shall have the right to grant to any person(s) or
entity(ies) the right and license to manufacture the Products, and
to do the foregoing itself. If there occurs any other or additional
material breach or failure of SMI to perform its duties under this
Agreement within six (6) months after the date of the initial
material breach or failure to perform (excluding any cure period)
or at any time thereafter if the initial material breach or failure
to perform remains uncured, all rights granted to SMI by InnoZen
under this Agreement (including without limitation all Right of
First Refusal rights, Patent Rights and Product and Licensed
Technology rights) shall terminate, become null and void, and shall
revert in their entirety to InnoZen, and InnoZen may, in its sole
option, terminate this Agreement in its entirety. This
Section 3.5(c) shall apply and be enforceable at all times
during the term of this Agreement including both prior to
SMI’s exercise of the Right of First Refusal for any Products
and after the exercise of such Right of First Refusal for any
Products.
3.6. Manufacturing Agreements. The
manufacturing relationship between the Parties shall be governed by
this Agreement and by a separate Manufacturing Agreement to be
negotiated by the parties in good faith for each particular
Product. Each such Manufacturing Agreement shall be in the form
attached hereto as Exhibit A and shall contain the
standard provisions therein, including but not limited to,
provisions relating to payment terms, forecasting/projections,
purchase orders, shipping, product specifications, and product
returns. In the event of a conflict between this Agreement and any
Manufacturing Agreement, the provisions of this Agreement shall
govern.
3.7. Pricing. The Parties shall negotiate
(in good faith) and agree upon the price for each Product that will
be charged to InnoZen by SMI for any orders placed by InnoZen on
its own behalf or on behalf of an InnoZen designated third party.
The Parties hereby agree to use best efforts to negotiate a price
for each Product that is low enough to be competitive in the
industry. In the event that the Parties are unable to agree upon a
price for any Product, the Parties hereby agree that for any such
Product orders placed by InnoZen on its own behalf or on behalf of
an InnoZen designated third party, SMI shall only charge InnoZen
for the Cost of such order plus a fee of [***] of such
Cost.
3.8. Audit Rights; Records. SMI shall
keep, or cause to be kept, accurate books, records and data in
sufficient detail to verify the calculation of Cost under
Sections 1.3 and 3.7 herein and shall retain such books,
records and data at its principal place of business for at least
five (5) years after the end of the fiscal year to which they
pertain. InnoZen shall have the right, at its expense and not more
frequently than once per quarter, to have its accountants and/or
auditors examine, during normal business hours, all books, records
and data of SMI or its Affiliates relating to the calculation of
Cost for any period during which SMI is required to keep the books,
records and data. If such examination discovers an error in excess
of three p
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