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LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

Development Agreement

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT | Document Parties: CARDICA INC | Cook Incorporated You are currently viewing:
This Development Agreement involves

CARDICA INC | Cook Incorporated

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Title: LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Governing Law: Delaware     Date: 1/4/2006
Industry: Medical Equipment and Supplies    

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT, Parties: cardica inc , cook incorporated
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[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

EXHIBIT 10.13

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 


 

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

9 December 2005

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     THIS AGREEMENT (“ Agreement ”), made this 9 th day of December, 2005 (“ Effective Date ”), is entered into by and between Cook Incorporated, an Indiana corporation having a place of business at 750 Daniels Way, Bloomington, Indiana 47404, USA, and its Affiliates (“ Cook ”), and Cardica, Inc., a Delaware corporation having a place of business at 900 Saginaw Drive, Redwood City, CA 94063, and its Affiliates (“ Cardica ”).

RECITALS

A.

 

Cardica is developing a medical device known as the X-Port for use in femoral access closure procedures, among other applications.

B.

 

Cook in engaged in the business of developing, manufacturing and selling medical devices.

 

C.

 

Cook is amenable to funding certain development work to be performed by Cardica in exchange for receiving a license under the terms and conditions set forth herein to continue to develop and to commercialize the X-Port device worldwide for femoral access closure procedures, as further described in this Agreement.

The parties agree as follows:

ARTICLE I

DEFINITIONS

In addition to the terms defined elsewhere in this Agreement, the following terms have the meanings set forth below:

1.1

 

Affiliates with respect to a party means any entity, existing now or in the future, domestic or foreign, that directly or indirectly controls, is controlled by or is under common control with such party; provided that such entity will be considered an Affiliate only for the time during which such control exists.

1.2

 

Approval means receipt from the applicable regulatory authority in a given country or countries to market a Product in such country or countries.

 

1.3

 

Cardica Know-How means Information that (a) is necessary or useful for the research, development or commercialization of Products, and (b) is Controlled by Cardica. Cardica Know-How shall exclude Cardica Patents.

1.4

 

Cardica Patents means a Patent that (a) claims the Product or any component thereof, or any other method, apparatus, material or article of manufacture useful in the development, manufacture, use or sale of Product, and (b) is Controlled by Cardica.

1


 

 

1.5

 

Clinical Feasibility Trial means the initial human clinical trial conducted in Europe on Products that is expected to include between 100 and 200 subjects.

 

1.6

 

Control means, with respect to any Information or intellectual property right, the right and power of the relevant party to grant the right to make, use, sell, offer to sell, and import, or to grant a license or a sublicense to, such Information or intellectual property right as provided for herein and without violating the terms of any agreement or other arrangement with any Third Party.

1.7

 

Cook Know-How means Information that (a) is necessary or useful for the research, development or commercialization of Products, and (b) is Controlled by Cook. Cook Know-How shall exclude Cook Patents.

 

1.8

 

Cook Patents means a Patent that (a) covers the Product or any component thereof, or any other method, apparatus, material or article of manufacture useful in the development, manufacture, use or sale of Product, (b) claiming an invention conceived by employees or agents or independent contractors of Cook that have access to the Confidential Information of Cardica related to the Product, and (c) is Controlled by Cook.

1.9

 

Field means use of the Product in any suitable medical procedure anywhere in the body.

 

1.10

 

Invention means any article, material, process or technology, whether or not patentable, made or conceived in the course of developing and commercializing Products pursuant to this Agreement, in whole or in part by a party, its employees, agents, or independent contractors, that have access to the Confidential Information of the other party .

1.11

 

Information means (a) techniques and data relating to the development, manufacture, use or sale of Products, including, but not limited to, inventions, practices, methods, knowledge, know-how, skill, experience, test data including pre-clinical and clinical test data, analytical and quality control data, regulatory submissions, correspondence and communications, marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data or descriptions, and (b) compositions of matter, devices, prototypes, articles of manufacture, assays and biological, chemical or physical materials relating to development, manufacture, use or sale of Products.

 

1.12

 

Net Sales means the gross revenue actually received by Cook, its Affiliates or sublicensees from the commercial sale of the Products during a given period of time, minus, to the extent billed to the purchaser, the costs of (i) sales, value added and/or use taxes, (ii) duties and similar governmental assessments paid, (iii) transportation, packing, shipping, and insurances, (iv) discounts allowed and taken (not to exceed two percent (2%) of the gross revenue actually received), and (v) amounts allowed or credited due to rejections and/or returns. If the Products are sold as part of a kit, then royalties due with respect to Net Sales of Products will be determined using the formula set forth in

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

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Sections 5.4(C) and (D). Net Sales shall be determined in accordance with generally accepted accounting principles, consistently applied.

1.13

 

“Other Cardica IP” shall mean any intellectual property rights that are necessary or useful for the research, development or commercialization of Products, and Controlled by Cardica, other than the Cardica Patents and Cardica Know-How.

 

1.14

 

“Other Cook IP” shall mean shall mean any intellectual property rights that are necessary or useful for the research, development or commercialization of Products, and developed by Cook employees having access to the Confidential Information of Cardica related to the Product and Controlled by Cook, other than the Cook Patents and Cook Know-How.

1.15

 

Patent means (a) unexpired United States and foreign patents, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal of such patents and (b) pending applications for such patents, including without limitation any continuation, divisional or continuation-in-part thereof and any provisional applications.

 

1.16

 

Product means the product designated by Cardica as of the Effective Date of this Agreement as the X-Port device, size [*] as illustrated in Exhibit C of this Agreement, and any improvements thereto relating to vascular access closure developed under this Agreement, including without limitation X-Port devices in formats other than size [*], expressly excluding any devices not relating to vascular access closure, such as any device used in the closure of holes made in the performance of an anastomosis.

1.17

 

Sunk Costs means pro-rated amounts for any work actually performed by Cardica under the Development Plan up to the effective date of termination and supported by documentation provided by Cardica to Cook, including [*] overhead for such work and all expenditures for such work and non-cancelable commitments that are consistent with the original budget and milestones set forth in the Development Plan and incurred by Cardica in performing the Development Plan prior to Cardica’s receipt or refusal of Cook’s notice of termination.

 

1.18

 

Territory means worldwide.

1.19

 

Third Party means any person or entity other than Cardica or Cook, or their respective Affiliates.

 

1.20

 

Unexpectedly Low Sales means sales in three consecutive quarters of a number of Products less than [*] of the number forecast under Section 2.4.

1.21

 

Valid Claim means an unexpired claim of an issued Patent which has not been found to be unpatentable, invalid or unenforceable by an unreversed and unappealable decision of a court or other authority in the subject country and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

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ARTICLE II

DEVELOPMENT AND COMMERCIALIZATION

2.1

 

Development Committee . Each party will appoint two (2) representatives to form a development committee that will be responsible for making day to day decisions regarding the strategy for the development of prototypes of Products in accordance with this Agreement (“ Development Committee ”). Such decisions will be made by unanimous consent of the Development Committee. In the event unanimous consent regarding a development issue can not be reached by the Development Committee during any meeting of the Development Committee, then a cooling off period of at least two (2) but no more than seven (7) calendar days will follow such meeting after which period all of the members of the Development Committee will meet again. In the event that the Development Committee is unable to achieve unanimous consent after the cooling off period, a senior executive from each party will meet to resolve the issue.

2.2

 

Prototype Product Development . The respective obligations of the parties for developing prototypes of the Product are set forth in Attachment A to this Agreement (“ Development Plan ”), which may be modified from time to time to time in accordance with Section 11.9 (Integration) of this Agreement, and which is hereby incorporated by reference. Each party will use commercially reasonable efforts to perform its obligations under the Development Plan. In the event a conflict arises between this Agreement and the Development Plan, the terms of this Agreement will control.

 

2.3

 

Production Product Development . After the development of a prototype of a Product that the Development Committee considers suitable and feasible for successful commercialization (“ Feasible Prototype ”), Cook will use commercially reasonable efforts to develop a production version of the Product for sale in the Field and in the Territory, at its expense, within a specified time period to be agreed upon by the parties. Without limiting the foregoing, Cook will use commercially reasonable efforts to apply for a CE Mark and FDA Approval within a reasonable period of time after the development of a Feasible Prototype. It is understood that commercially reasonable efforts to develop a production version of the Product may be unsuccessful, and that neither party guarantees or can guarantee that commercially reasonable efforts to implement the Development Plan will result in a production version of the Product or in a saleable Product.

2.4

 

Commercialization . Cook will use commercially reasonable efforts to commercialize Products for use in the Field in each country in the Territory in which it obtains regulatory approval, at its expense. Without limiting the foregoing, Cook will be responsible, at its cost, for promoting, detailing and distributing Products for use in the Field in each country in the Territory in which it obtains regulatory approval, and will book all resulting Product sales. Following the Approval of Product, Cook will provide to Cardica on a semi-annual basis its good faith non-binding quarterly forecast of Product sales in the Field and in the Territory for the following eighteen (18) month period.

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

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2.5

 

Development Costs . Except as otherwise expressly provided in this Agreement, each party will make its resources available that it reasonably deems necessary to fulfill its obligations under this Agreement and shall bear its own costs incurred with respect thereto.

2.6

 

Specifications. The Development Committee will approve Product specifications for each type of Product being developed, which specifications may be updated from time to time.

ARTICLE III

OWNERSHIP OF INTELLECTUAL PROPERTY

3.1

 

Ownership of Inventions . Ownership by the parties of Inventions will be determined in accordance with the rules of inventorship and ownership under US law.

3.2

 

Joint Inventions. With respect to Inventions jointly owned by the parties, each party will enjoy all of the rights of an owner thereof with no duty to account to the other party regarding any economic benefit realized and no need to seek approval from the other party for its disclosure or use of such Invention, except with respect to exclusivity provisions expressly stated in this Agreement. Each party’s interest in such jointly owned Inventions and intellectual property rights therein will be included in such party’s intellectual property rights that are either licensed to the other party or the subject of covenants made to the other party pursuant to this Agreement.

 

3.3

 

Prosecution . The parties will cooperate in good faith to decide whether to seek patent protection for any Inventions that are owned jointly by the parties. The party solely owning an Invention will be responsible, but not obligated, for filing and prosecuting patent applications on such Inventions, and maintaining patents issued thereon, at such party’s sole expense. If a party responsible for filing patent applications on Inventions solely owned by such party decides not to proceed with the filing, prosecution or maintenance of patent applications and patents on such Invention (without first filing a continuation or continuation in part of any such application), such party shall notify the other party in writing in advance of relevant deadlines, and the other party shall have the right, but not the obligation, to assume responsibility for such activities, on behalf of the sole owner but at the assuming party’s sole expense. The parties will meet to discuss whether or not to pursue patent protection for Inventions jointly owned by the parties. If the parties agree to pursue such protection for such Inventions, they shall designate one party to be responsible for filing and prosecuting patent applications on such Inventions, and for maintaining patents issuing thereon. Unless otherwise agreed by the parties, the parties will share equally all expenses of pursuing and maintaining patent protection on jointly owned Inventions that they agree to pursue under this Section 3.3. Each party will have the right to review and comment on the other party’s correspondence with any patent office with regard to patent applications and patents on Inventions that are necessary or useful for the development and commercialization of Products in the Field.

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

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3.4

 

Enforcement .

 

A.

 

Cook has the first right to enforce patents licensed to it by Cardica against Third Parties that make, use, offer for sale, sell, or import products that are covered by such patents and that are competitive with Products in the Field. If Cook elects not to undertake such enforcement, then Cardica may request and Cook may, in its sole discretion, permit Cardica to enforce such patents against such Third Parties, such permission not to be unreasonably withheld.

 

 

B.

 

Each party will cooperate with the other party when asserting patents against Third Parties in accordance with this Section 3.4. A party enforcing a patent against a Third Party will give the other party notice prior to bringing any enforcement action (including, but not limited to, injunctions or restraining orders). The other party will have the right to participate or not participate in such enforcement, at its sole discretion. If the other party chooses to participate, it will bear its own expenses and/or share expenses, as the parties jointly determine to be appropriate. If the other party chooses not to participate in an enforcement action brought in accordance with this Section 3.4, it nonetheless agrees to be named in the enforcement action, and upon request and at the cost of the enforcing party, will make available all relevant information in its possession or under its control.

 

C.

 

Any money damages obtained as a result of any enforcement action under this Section 3.4 shall first be allocated to reimburse the parties’ respective expenses of such enforcement, and the remainder of such proceeds, if any, shall be allocated [*] percent ([*]) to the party controlling such suit, and [*] percent ([*]) to the other party.

 

 

D.

 

If the sales volume of the Product in a calendar year is less than $[*], Cook may offset against any payment due under Sections 5.4 or 5.5 of this Agreement up to [*] percent ([*]) of any monies expended by Cook in defending Products against assertions of intellectual property rights by third parties. If the sales volume of the Product in a calendar year is at least $[*], then Cook may offset against any payment due under Sections 5.4 or 5.5 of this Agreement an amount that is the lesser of (i) [*] percent ([*]) of any monies expended by Cook in defending Products against assertions of intellectual property rights by third parties or (ii) [*] percent ([*]) of the total payment due to Cardica under Sections 5.4 and 5.5.

3.5

 

Cardica Patent Prosecution . Cardica will use reasonable efforts to obtain patents included in the Cardica Patents in [*]. Cardica will notify Cook of Cardica’s foreign filing decisions with respect to each of the Cardica Patents in writing in advance of relevant deadlines, and Cook will have the right, but not the obligation, to assume responsibility at Cook’s sole expense for pursuing and/or maintaining foreign patent protection for any of the Cardica Patents in any country that Cardica decides not to pursue or to abandon.

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

6


 

ARTICLE IV

LICENSE AND COMMERCIALIZATION

4.1

 

By Cardica. Subject to the terms and conditions of this Agreement, Cardica hereby grants to Cook and its Affiliates an exclusive license in the Territory, bearing royalties as set forth in this Agreement, with the right to grant sublicenses, under the Cardica Patents, Cardica Know-How and Other Cardica IP, to make, have made, use, sell, offer for sale and import Products for use solely in the Field and in the Territory. For clarity, Cardica grants the foregoing exclusive license to the fullest extent possible under the Cardica Patents, Cardica Know-How and Other Cardica IP in the Field and in the Territory with respect to Products, retaining only rights to the extent necessary or useful for Cardica to perform its responsibilities under the Development Plan with respect to Product in the Field and in the Territory.

4.2

 

Cardica Representations. Cardica represents and warrants that as of the Effective Date: (a) Cardica has the right and power to enter into this Agreement and to grant the rights it grants to Cook under this Agreement; (b) it has not assigned, granted a license under or otherwise transferred or encumbered any intellectual property licensed to Cook under this Agreement in a manner inconsistent with this Agreement, other than grants of security interests disclosed pursuant to a letter agreement of even date herewith; (c) to its knowledge, Cook’s practice of the license granted to Cook pursuant to this Agreement under the Cardica Know-How, Cardica Patents and Other Cardica IP will not infringe any Patents owned or controlled by a Third Party; (d) its performance under this Agreement is not inconsistent with any obligation owed to a third party; and (e) its employees and/or agents assigned to perform work under a Development Plan have executed agreements that enable Cardica to grant the rights it grants to Cook under this Agreement. Additionally, Cardica represents, warrants and covenants that it has not employed, contracted with or retained, and shall not employ, contract with or retain, any person or entity in connection with the development or manufacture of Products in the Field pursuant to this Agreement who has been or is debarred by the FDA under 21 U.S.C. § 335(a) or disqualified as described in 21 C.F.R. §812.119.

 

4.3

 

By Cook. Cook agrees not to sue Cardica under any Cook Patents, Cook Know-How, or Other Cook IP solely to the extent necessary or useful for Cardica to perform its responsibilities under the Development Plan with respect to Product in the Field and in the Territory. Subject to the terms and conditions of this Agreement, and upon request by Cardica, the parties shall negotiate in good faith the terms of a non-exclusive, royalty-bearing license for use by Cardica in developing and commercializing products other than the Products under all Cook Patents, Cook Know-How and Other Cook IP covering Inventions as defined in Section 1.10, which license Cook in its sole discretion may elect, but is not obligated, to execute with Cardica.

4.4

 

Cook Representations. Cook represents and warrants that as of the Effective Date: (a) Cook has the right and power to enter into this Agreement; (b) its performance under this

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

7


 

 

 

Agreement is not inconsistent with any obligation owed to a third party; (c) to its knowledge, Cardica’s practice of the covenant not to sue granted to Cardica pursuant to Section 4.3 of this Agreement under the Cook Know-How, Cook Patents and Other Cook IP will not infringe any Patents owned or controlled by a Third Party; and (d) its employees and/or agents assigned to perform work under a Development Plan have executed agreements that enable Cook to grant the rights it grants to Cardica under this Agreement. Additionally, Cook covenants that it shall not employ, contract with or retain any person or entity in connection with the development, manufacture and commercialization of Products in the Field pursuant to this Agreement who has been or is debarred by the FDA under 21 U.S.C. § 335(a) or disqualified as described in 21 C.F.R. §812.119.

4.5

 

No Implied Licenses. Neither party grants to the other party any licenses or covenants not to sue under such party’s intellectual property rights except as expressly provided in this Agreement.

ARTICLE V

CONSIDERATION

5.1

 

Signing Fee . Cook will pay Cardica a one-time payment of Five Hundred Thousand Dollars ($500,000) due after execution of this Agreement by both parties and payable within ten (10) days after Cardica’s completion, to Cook’s satisfaction, of the tasks identified in the paragraph entitled “Animal Testing” of the section identified as “Phase 1” of the Development Plan attached to this Agreement as Exhibit A.

5.2

 

Milestone Payments . Cook will pay Cardica a one-time payment of One Million Five Hundred Thousand Dollars ($1.5 million) for the design and development of the first Feasible Prototype of a Product in [*] format (as provided in the Development Plan) (“[*] Format”) in [*], each due within thirty (30) days following the achievement of the relevant milestone as set forth below:

 

 

A.

 

[*] upon the date the Development Committee determines that the results of the acute animal testing of Products in [*] Format in the Field as provided in the Development Plan support the commencement of pre-production tooling efforts by Cardica.

 

B.

 

[*] upon completion of verification and validation testing as set forth in the Development Plan and confirmed by the Development Committee of Products in [*] Format produced by Cardica using the pre-production tooling described in Section 5.2(A) (“ Pilot Product ”) to support commencement by Cook of a Clinical Feasibility Trial of such Product in the Field.

 

 

C.

 

[*] upon the delivery of [*] ([*]) Pilot Products in [*] Format to Cook for use in the first Clinical Feasibility Trial of such Products in the Field, as provided in the Development Plan.

[*] = CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. WITH RESPECT TO ATTACHMENT A, SIX PAGES OF INFORMATION HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

8


 

5.3

 

Reimbursement for Products in Other Formats . Cook will reimburse Cardica for additional reasonable research, development and tooling costs actually incurred by Cardica for the development of Feasible Prototypes and the production of Pilot Product in formats other than [*] as requested by Cook and completed by Cardica in accordance with a research plan and budget approved in advance and in writing by each member of the Development Committee. Such reimbursements will be calculated using full time equivalent rates for engineering services and labor and will include Cardica’s reasonable and actual out of pocket expenses for fabrication of the pre-production tooling, fixtures and prototypes. Cardica shall add an overhead charge of [*] percent ([*]) of the amounts to be so reimbursed, and Cook shall pay such additional amounts, to compensate Cardica for overhead expenses. The agreed upon research plan and budget will establish the milestones and timing to be met by Cardica in order for such reimbursement payments to be made by Cook to Cardica.

5.4

 

Earned Royalties .

 

 

A.

 

 i) Cook will pay to Cardica (on a quarterly basis) during the Term of this Agreement a royalty based on Net Sales by Cook, its
    Affiliates or sublicensees (“ Earned Royalty ”) of Product units in the calendar year in which such quarter occurs, as follows:

 

 

 

 

 

Royalty Due (% of Net Sales of

 

Portion of Aggregate Number of

 

Product Units)

 

Product Units Sold in Calendar Year

 

[*]

 

[*]

 

 

[*]

 

[*]

 

 

[*]

 

[*]

 

 

 

 

 

 

ii) In the event that Cook sells more than [*] units of Product per calendar year for [*] consecutive ca


 
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