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CUSTOM TECHNOLOGY ACCESS AND PRODUCT LICENSE AGREEMENT
This Custom Technology Access and Product License Agreement (the “ Agreement ”) is made and entered into as of the 17 th of November, 2010 (the “ Effective Date ”), by and between Cardium Therapeutics, Inc., a Delaware corporation with offices at 12255 El Camino Real, Suite 250, San Diego, CA 92130, on behalf of itself and its affiliates (“ Cardium ”) and BioZone Laboratories, Inc., a California C corporation, with offices at 580 Garcia Ave., Pittsburg, CA 94565, and its affiliate EquaChem LLC, a California limited liability company, with offices at 580 Garcia Ave., Pittsburg, CA 94565 (individually and collectively “ BioZone ”). Cardium and BioZone are each referred to as a party and collectively parties to this Agreement.
Cardium desires to acquire from BioZone access to certain BioZone technology and a license and supply arrangement for a portfolio of products (the “ Schedule A Products ” and “ Schedule B Products ” described below, collectively the “ Products ”) for distribution and resale worldwide by Cardium and/or its agents, affiliates or transferees and BioZone is willing to license and supply the Products to Cardium as provided herein.
NOW, THEREFORE, for good and valuable consideration, the parties, intending to be bound legally, agree as follows:
1. Term . The initial term Agreement shall begin on the Effective Date, and unless earlier terminated by either party as provided under Sections 15 or 16, shall end on the Tenth (10 th ) anniversary of the Effective Date (the “ Initial Term ”). This Agreement shall automatically renew for additional one year terms (each a “ Renewal Term ”) after the end of the Initial Term unless either party gives the other notice of termination (a “Termination Notice”) at least 180 days before the end of the Initial Term or a Renewal Term in accordance with the provisions of Section 15 or 16 of this Agreement. The “ Term ” shall include the Initial term and all Renewal Terms.
2. Technology License and Product License .
(a) BioZone possesses technology and intellectual property rights (including without limitation patents, patent applications and unpatented inventions, as well as trade secrets, know-how, data and other technical or commercially useful information) which is owned, in-licensed or otherwise used by BioZone or its affiliates (collectively, the “ BioZone Technology ”) and is relevant to or useful for the design, formulation, manufacture or commercialization of its products and technologies (“ BioZone Products ”). BioZone hereby grants to Cardium a license (the “ BioZone Technology License ”) to use of the BioZone Technology, now existing or hereafter developed, solely on the terms and conditions contained in this Agreement.
(b) Under the BioZone Technology License, Cardium shall be entitled to ten (10) licensed Products that are unique customizations of BioZone products, designated and formulated as provided below pursuant to the terms of this Agreement (“ Schedule A Products ”). The products shall not be prescription drug products.
(c) Under the BioZone Technology License, Cardium shall be entitled to ten (10) licensed Products that are unique customizations of Cardium or third party products, designated and formulated as provided below pursuant to the terms of this Agreement (“ Schedule B Products ”).
(d) BioZone hereby grants to Cardium an exclusive, transferable right and royalty-free license (the “ Product License ”) to make, have made, import, sell, offer for sale and otherwise commercialize the Products.
3. Technology License and Product License Fee; Stock Purchase .
(a) In connection with BioZone’s grant of the Technology License and Product licenses as provided above, Cardium shall pay to BioZone an upfront license fee (the “ Technology Access and License Fee ”) of One Million Dollars ($1,000,000) . In connection with payment of the Technology Access and License Fee, BioZone shall purchase Two Million Shares (2,000,000) of Cardium’s common stock (the “ Cardium Common Stock ”) at the price of Fifty Cents ($0.50) per share.
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(b) The Cardium Common Stock shall be unregistered shares granted in accordance with the terms of a stock transfer agreement (the “ Stock Transfer Agreement ”) attached as Exhibit 1 . Transfer of the Cardium Common Stock is subject to a lock up agreement between the parties such that no shares shall be transferable for a period of six months from the date of this Agreement and thereafter may be transferred in five equal monthly installments. The Cardium Common Stock will be deposited with an escrow agent pending observance of the lock up provisions, pursuant to the terms of an escrow agreement (the “ Escrow Agreement ”) attached as Exhibit 2 .
4. Associated Technical Cooperation and Assistance for Licensed Products .
(a) Upon the written request of Cardium in connection with the potential designation of a prospective Schedule A or Schedule B Product, BioZone shall provide Cardium with all reasonably required technical cooperation and assistance to enable a full and complete assessment of: (i) the characteristics of the product, including without limitation its ingredients and their sources, formulation, costs of production and potential uses relative to competitive products (“ Product Characteristics ”); (ii) the product’s safety and risk profile relative to potential uses as reflected in any corresponding product complaints or reports (the “ Product Safety Profile ”); (iii) the means and cost of potential modifications of the product selected by Cardium; and (iv) any other information necessary or useful for the effective commercialization of the product by Cardium or its transferee.
(b) In the event that Cardium elects to proceed with the desired modification(s) of a BioZone, Cardium or third-party product, BioZone will apply its BioZone Technology and use its commercially reasonable best efforts to produce free test samples of the product meeting specifications acceptable to Cardium. Upon final acceptance of such product by Cardium, to be confirmed in writing by Cardium, it shall then constitute one of the Schedule A Products or Schedule B Products, as applicable. If testing is required by an outside service, Cardium will pay such costs.
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(c) At Cardium’s election and BioZone’s acceptance with respect to one or more Schedule B Products, the parties will confer to assess the projected cost and desirability of having such product manufactured by BioZone, and if they so agree in writing, then such product(s) shall constitute “ Manufactured Schedule B Product(s) ” pursuant to this Agreement.
5. Manufacture and Supply of Licensed Products .
(a) BioZone shall exclusively manufacture and supply Schedule A Products and any Manufactured Schedule B Products (collectively “ Manufactured Products ”) to Cardium in strict compliance with (i) the product specifications developed for each Manufactured Product (the “ Product Specifications ”); (ii) the process specifications developed for the manufacturing and testing of products in general, the “ Standard Process Specifications ” which are attached as Exhibit 3 , together with individual specifications and proposed batch records for the manufacture and testing of specific products, the “ Individual Process Specifications ” (all of which are referred to individually and collectively as the “ Process Specifications ”), and (iii) all applicable laws and governmental regulations (“ Governmental Standards ”).
(b) Cardium may by written notice to BioZone, request changes to Product or Process Specifications for one or more Products. BioZone shall notify Cardium in writing (a “ Change Report ”) within ten days after receipt of notice of any request for changes to such Specifications, of the cost and lead time required to incorporate the requested changes. If Cardium wishes to proceed with the change, it shall sign and return to BioZone a copy of the Change Report. If the change proceeds, the cost of the associated Product shall reflect the modification as provided in the Change Report.
(c) Unless otherwise agreed to for a particular Product or component thereof, all manufacture, fill and finish processing, and testing will be performed solely by qualified personnel at BioZone’s accredited manufacturing facility located at 580 Garcia Ave., Pittsburg, CA. (the “ Manufacturing Location ”). BioZone will not alter the Manufacturing Location, the sources of any Product components, or any Product or Process Specifications without Cardium’s prior written approval.
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(d) All purchases of Manufactured Products by Cardium under this Agreement shall be under the terms and conditions of Cardium’s purchase order form (“ PO ”), the minimum terms of which shall be as shown on the attached Exhibit 4 , with such other terms as Cardium may specify, which may be delivered by facsimile, courier or other means providing a record of receipt (the “ Date of PO Receipt ”). The terms and conditions of the PO shall be in addition to and not in limitation of the terms and conditions of this Agreement. Any conflict between the terms and conditions of the PO and the provisions of this Agreement shall be resolved in favor of the provisions of this Agreement.
(e) Unless otherwise agreed to by the parties, BioZone shall manufacture and ship Manufactured Product to Cardium or to one or more of Cardium’s designees within Thirty (30) days of the last raw material, ingredient or component being available to BioZone for the Manufactured Product, via carrier designated by Cardium.
(f) BioZone shall provide Cardium with all information reasonably required or appropriate and advise on the proper labeling of Manufactured Products based on their intended uses. If requested by Cardium, BioZone shall fill, label and package Manufactured Product using artwork, graphics, and label copy that Cardium shall furnish and that shall remain the property of Cardium. BioZone shall include, in each package, such package inserts as are specified by Cardium. Whether filled, labeled and packaged by BioZone, Cardium or a third party, BioZone shall provide Cardium with all Product information required for preparation of any Product label and package inserts. If required by applicable federal or international regulations or requested by Cardium, packages of Manufactured Product filled by BioZone or a third party shall also identify BioZone as the manufacturer.
(g) BioZone will promptly apprise Cardium upon the occurrence of any facts reasonably likely to impact the accreditation of its manufacturing facilities, or the ability of BioZone to manufacture Products complying with the Specifications and Governmental Standards, or any other matters related to regulatory compliance that could affect or delay BioZone’s production of Manufactured Product. BioZone will promptly apprise Cardium of any regulatory compliance audits related to BioZone’s facilities or to BioZone products or to the components of such products
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that could affect or delay BioZone’s production of Manufactured Product, or which could impact the actual or perceived safety or usefulness of Manufactured Product. BioZone will cooperate fully with Cardium in the event that any Manufactured Product is associated with product safety issues or a product recall, and shall bear the costs of any associated safety issues or recall.
6. Exclusive Rights to Cardium Customized Products . BioZone acknowledges and agrees that the Schedule A Products and Schedule B Products specified under this Agreement shall constitute Products customized for and owned by Cardium, and BioZone shall not design, formulate, manufacture or sell such Products itself or to any third party, nor will it convey or reveal any BioZone Technology used to customize such products to any third party nor