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Exhibit 10.1

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”).

RECITALS

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:

I. DEFINITIONS

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.

1.14. [***]

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.

________________

[***]

 

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

3.1. [***]

3.2. [***]

________________

[***]

 

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


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