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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: ROUGHNECK SUPPLIES INC. | COLUMBIA UNIVERSITY | OMNIMMUNE CORP You are currently viewing:
This License Agreement involves

ROUGHNECK SUPPLIES INC. | COLUMBIA UNIVERSITY | OMNIMMUNE CORP

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Title: LICENSE AGREEMENT
Date: 8/12/2008

LICENSE AGREEMENT, Parties: roughneck supplies inc. , columbia university , omnimmune corp
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Exhibit 10.8

 

LICENSE AGREEMENT

 

 

AGREEMENT , dated as of February 1, 2005 (the “Effective Date”), between THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, a New York corporation located at 116th Street and Broadway, New York, New York 10027 (“Columbia”), and OMNIMMUNE CORP., a Texas corporation located at 4600 Post Oak Place, Suite 152, Houston, Texas 77027 (“Company”).  The parties therefore agree as follows:

 

1.            Definitions .

 

a           “Affiliate” shall mean any corporation or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Company.  Control means ownership or other beneficial interest in 50% or more of the voting stock or other voting interest of a corporation or other business entity.

 

b.   “Claim” shall mean a claim (a) of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, or ( b) of any patent application that has not been cancelled, withdrawn or permanently abandoned nor been pending for more than (i) seven (7) years, if such patent application is pending in any country other than Japan or (ii) ten (10) years, if such patent application is pending in Japan.

 

c.           “Confidential Information” As used in this Agreement, the term “Confidential Information” shall mean all confidential or proprietary materials or information designated as such in writing by the party disclosing such information (the “Disclosing Party”), whether by letter or by the use of an appropriate proprietary stamp or legend, prior to or at the time any confidential or proprietary materials or information is disclosed by the Disclosing Party to the receiving party (the “Recipient”).  Notwithstanding the foregoing, information or materials which are orally or visually disclosed to the Recipient by the Disclosing Party, or are disclosed in writing or other tangible form without an appropriate letter, proprietary stamp or legend, shall constitute Confidential Information if the Disclosing Party, within thirty (30) days after such disclosure, delivers to the Recipient a written document or documents describing such information or materials and referencing the place and date of such oral, visual or written or other tangible disclosure, and the names of the employees or officers of the Recipient to whom such disclosure was made.

 

d.           “Effective Date” shall mean February 1, 2005

 

e.           “Fair Market Value” shall mean the cash consideration which the Company, its affiliate or sublicensee would realize from an unaffiliated, unrelated buyer in an arms’ length sale of an identical item sold in the same quantity and at the same time and place of the transaction.

 

f           “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereof or foreign counterpart thereof.

 

g           “Field” shall be subdivided into the following “Subfields:” (i) The “Therapeutic Subfield” shall mean cancer  therapy (active and passive immunotherapy) in humans   and non-humans and fertility control in non-humans   .  (ii) The “Animal Subfield” shall include all therapeutic treatment in non-humans.  (iii) The “Diagnostic Subfield” shall include all diagnostics in humans and non-humans.

 

h           “First Sale” shall mean, with respect to a Licensed Product in a country, the first commercial sale of the Licensed Product by Licensee, its Affiliates or sublicensees in such country.  Sales for test marketing, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Sale.

 

i.           “Know-How shall mean any information, inventions, discoveries, copyrights, trade secrets, data or materials, whether proprietary or not, including without limitation data generated in pre-clinical and clinical studies.

 

j.           “Licensed Information” shall mean research and development information, records and data, unpatented inventions, Know-How relating to Licensed Products in the Field that are (i) developed by Columbia through or under the direction of Drs. Robert Canfield, Steve Birken, Alexander Krichevsky and others under their direction at Columbia   prior to the   Effective Date of this Agreement and ( ii) which is provided by Columbia to Company or is provided by a third party to Company at Columbia’s authorization.

 

k.           “Licensed Material” shall mean the tangible physical material that (i) are   listed in Attachment A hereto or (ii) any Company developed progeny or derivatives thereof including those antibodies listed in Attachment A, and any MAb and/or cell lines that Company, its Affiliates, successors or Sublicensees acquire that are derived from amino acid, peptide, or DNA sequences of the antibodies listed in Attachment A.  MAb’s shall also be deemed to include the use of respective cell lines used to produce MAb’s.

 


 

l.           “Licensed Patents” shall mean:

 

(i)           the United States and foreign patents and patent applications listed in Attachment A hereto, and any patents issuing therefrom that are owned or controlled, in whole or in part, by Columbia as at the date hereof, including. provisional patent applications and PCT patent applications, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;.

 

(ii)           to the extent that the following contain one or more claims directed to the invention or inventions disclosed in (i) above: a) continuations-in-part of (i) above; b) all divisions and continuations of these continuations-in-part; c) all patents issuing from such continuations-in-part, divisions, and continuations; and d) any reissues, reexaminations, and extensions of all such patents;

 

 

(iii)           to the extent that the following contain one or more claims directed to the invention or inventions disclosed in a) above: all counterpart foreign applications and patents to (i) and (ii) above, including those listed in Appendix A.

 

 

m.           “Licensed Products” shall mean any product or service, the development, manufacture, use, sale, rental or lease of which (i) is covered by a claim of a Licensed Patent or (ii) involves the use of Licensed Material and/or Licensed Information.

 

n.           “Net Sales” shall mean the total of all cash consideration or, if none, the Fair Market Value attributable to the Sale of Licensed Products by the Company and its Affiliates and Sublicensees, less returns and customary trade discounts actually taken, outbound freight, transportation insurance, value added, sales or use taxes, and custom duties, and reasonable reserve for bad debts accrued in accordance with the Company’s standard accounting practices applied consistently across the Company’s and its Affiliates business.  In the case of transfers of Licensed Products to an Affiliate by the Company for sale, rental, or lease of such Products to third parties by such Affiliate, Net Sales shall be based upon the greater of the total fees and other consideration charged by the Affiliate to third parties or the total fees and consideration charged by the Company to the Affiliate.  Net sales for Licensed Products sold by Company or its affiliate(s) or Sublicensee(s) as a unit in conjunction with other services or products will be determined pro rata in accordance with the respective stand-alone price or value of such products and/or services.

 

o.           “Sale” shall mean any bona fide transaction for which consideration is received or expected for the sale, use, lease, transfer or other disposition of Licensed Product(s).  A Sale of Licensed Product(s) shall be deemed to be completed at the time Company, its Affiliate or Sublicensee invoices for, ships, or receives payment for such Licensed Product(s), whichever occurs first.

 

p.           “Sublicensee” shall mean any third party to whom the Company has granted a sublicense pursuant to this Agreement.

 

            q.           “Sublicense Revenue” shall mean all amounts (except royalties on Net Sales by Sublicensees) actually received by the Company and/or its Affiliates from third parties in connection with or related to the licensing or sublicensing to such third parties of rights with respect to Licensed Products, including without limitation (a) all fees and milestone payments, (b) investment in securities and (c) research and development funding, subject, however, to subsections (i) and (ii) below:

 

(i)           At the Company’s sole discretion and on prior written notice to Columbia, Sublicense Revenue shall not include any amounts constituting (1) bona fide research and development funding directly relating to potential Licensed Products, as reflected in the Company’s books and records in accordance with generally accepted accounting principles, and are actually used for such purpose within the Company, and (2) amounts reimbursed by a third party for Company payments for bona fide research and development activities directly relating to potential Licensed Products, as reflected in the Company’s books and records in accordance with generally accepted accounting principles.  The parties acknowledge and agree that (x) the two exceptions to Sublicense Revenue described above in this subsection (i) shall apply only to direct expenses actually paid by the Company for bona fide research and development activities , including salaries of full and part-time employees, consultants and advisors , and shall only apply to research and development activities undertaken after the Effective Date of this Agreement and after execution of the relevant sublicense agreement; and (y) the Company may not include in amounts excluded from Sublicense Revenue its own internal costs other than those reasonably allocated to the R&D project related to Columbia’s Licensed Products.

 


 


 

(ii)           If and to the extent that a Sublicensee makes a bona fide equity investment in capital stock of Company, or a security convertible into or exchangeable for capital stock of the Company (a “Convertible Security”), then only such portion, if any, of the consideration paid for such capital stock or Convertible Security that is in excess of the aggregate Fair Market Value 1 of the shares of such capital stock issued or issuable by Company to Sublicensee shall be deemed to be Sublicense Revenue.

_____________

1            As used herein, the “Fair Market Value” per share of capital stock shall mean (A) if such class of capital stock is then traded on a national securities exchange or the Nasdaq National Market (or a similar national quotation system), an amount equal to the average of the closing prices per share of shares of such class of capital stock on such exchange or system for the twenty (20) trading-day period ending three (3) days prior to the date of issuance of such capital stock or Convertible Security to Sublicensee; (B) if such class of capital stock is then traded over-the-counter, an amount equal to the average of the closing bid prices per share of shares of such class of capital stock over the twenty (20) trading day period ending three (3) days prior to the date of issuance of such capital stock to Sublicensee; and (C) if such class of capital stock is not then traded on a national securities exchange, any such national quotation system or over-the-counter, an amount per share equal to the lowest amount of consideration per share paid in consideration for the bona fide issuance of any shares of such class of capital stock (other than to Sublicensee or to employees, consultants, directors or advisors (collectively “Optionees”) pursuant to the Company’s employee stock option plan) during the period beginning twelve (12) months prior to the date of issuance of such shares of capital stock to Sublicensee; provided that such amount shall be reduced from time to time to an amount equal to the lowest amount of consideration per share paid in consideration for the bona fide issuance of any shares of such class of capital stock (other than to Sublicensee (or Optionees) during the period ending twelve (12) months after the date of such issuance to Sublicensee, if the amount of any such consideration is less than the lowest amount of such consideration paid during the period beginning twelve (12) months prior to the date of such issuance to Sublicensee; provided, further, that if there has not been any bona fide issuance of shares of such class of capital stock (other than to Sublicensee or Optionees) during the twelve (12) months prior to the date of any such issuance to Sublicensee or if the consideration for such shares of capital stock issued by Company to Sublicense or to any other person or entity in an issuance within the twelve (12) months prior to or following the date of any such issuance to Sublicense consists of any consideration other than cash, then the Board of Directors of Company shall, within thirty (30) days following the date of such issuance to Sublicense (or the date of any issuance within 12 months following the date of issuance to Sublicense) make a good faith determination as to the Fair Market Value of the shares issued to Sublicense and furnish to Columbia a written report setting forth in reasonable detail the basis for such determination, and shall promptly furnish to Columbia all such additional information as Columbia may request in connection with its review of such determination.  If Columbia and Company fail to agree on such determination within (30) days following the date Columbia receives such report, then the Fair Market Value of such shares shall be determined by an independent accounting firm, investment bank or valuation firm which has not had any relationship with Columbia or the Company, an Affiliate or Sublicensee for a period of three years prior to such determination (the “Appraiser”); the parties, acting reasonably and in good faith, shall mutually agree upon the Appraiser.  Company shall promptly furnish to the Appraiser all such information as the Appraiser may request in connection with such determination.   The fees and expenses of the Appraiser shall be shared equally by the Company and Columbia; provided that if the Fair Market Value determined by the Appraiser is less than ninety-five (95%) of the Fair Market Value as determined by Company’s Board of Directors, then all such fees and expenses shall be borne by Company.

 

If non-monetary consideration is received from third parties by the Company and/or its Affiliates, then a commercially reasonable monetary value will be assigned for purposes of calculating Sublicense Revenue.

 

2.            License Grant :

 

a.           Columbia grants to the Company, upon and subject to all the terms and conditions of this Agreement

 

(i)           with respect to any right, title or interest Columbia may have in the Licensed Patents, and/or Licensed Material, a worldwide exclusive license under the Licensed Patents, and Licensed Material as specified in Attachment A, to develop, manufacture, use, sell, have sold, rent, or lease Licensed Products in the Therapeutic Subfield and the Animal Subfield; and

 

(ii)           with respect to any right, title or interest Columbia may have in the Licensed Patents, and/or Licensed Material, a worldwide non-exclusive license under the Licensed Patents, and Licensed Material as specified in Attachment A, to develop, manufacture, use, sell, have sold, rent, or lease Licensed Products in the Diagnostic Subfield, except that no license is granted in the Licensed Patents and/or Licensed Materials with respect to B152 as listed on Attachment A in the Diagnostic Subfield.

 

(iii)           with respect to any right, title or interest Columbia may have in the Licensed Information, a nonexclusive, worldwide license to use Licensed Information to develop, manufacture, use, sell, have sold, rent or lease Licensed Products in the Field as specified in Attachment A.  The Company will treat as confidential any and all Licensed Information furnished hereunder, and will not disclose the same to any third party without Columbia’s written permission.

 

b.           Columbia grants to the Company the right to grant sublicenses to third parties in the Field as specified in Attachment A, provided that (i) the Sublicensee agrees to abide by all the terms and provisions of this Agreement; (ii) the Company remains fully liable for the performance of its and its Sublicensee’s obligations hereunder; (iii) the Company notifies Columbia of any grant of a sublicense and provides to Columbia upon Columbia’s request a copy of any sublicense agreement; and (iv) no such sublicense shall relieve the Company of its obligations under Section 6 hereof.

 

c.           Except as expressly provided in this Agreement, Columbia is not granting the Company any rights or license to any patents, patent applications, copyrights, trade secrets, know how, trademarks or any other intellectual property right.

 

 


 

d.           All rights granted by Columbia to the Company under this Agreement are subject to the requirements of 35 U.S.C. '' 200 et seq. , as amended, and implementing regulations and policies.

 

e.            THE COMPANY ACKNOWLEDGES AND AGREES THAT COLUMBIA MAKES NO WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND, EXPRESS OR IMPLIED, REGARDING ANY RIGHT, TITLE OR INTEREST COLUMBIA MAY HAVE IN AND TO THE SUBJECT OF ANY LICENSE GRANT UNDER THIS SECTION AND THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LICENSED PATENTS, LICENSED INFORMATION AND LICENSED MATERIALS, AND ANY TECHNOLOGY EMBODIED THEREIN.

 

3.            Royalties and Payments .

 

a.           In consideration of the license granted under Section 2a of this Agreement, the Company shall pay to Columbia:

 

(i)           a nonrefundable and non-creditable license fee of $30,000 which shall be payable in accordance with the following schedule:

 

 

(a)

$15,000 sixty (60) days from the Effective Date of this Agreement

 

 

(b)

$15,000 one year from the Effective Date of this Agreement

 

 

(ii)

Company shall reimburse Columbia $50,000 for all past expenses in accordance with the following schedule:

 

 

(a)  

$25,000 two (2) years from the Effective Date of this Agreement; and

 

 

(b)

$25,000 after the sales by Company, its affiliates or Company’s successors or sublicensees, or any combination thereof, for the first $1,000,000 in sales of Licensed Products, as final payment for past patent expenses;

 

 

(c)

however, notwithstanding any of the above, Company will pay all past expenses estimated to be $4,300 upon 30 days from invoice with respect to U.S. Serial No. 10,164,914 .

 

 

(iii)

Five percent equity in Company as per the Stockholders Agreement attached hereto as Attachment B;

 

 

(iv)

a royalty of 1% of Net Sales of all Licensed Products that involve use of Licensed Material or Licensed Information but are not covered by a Claim of a Licensed Patent for a term of ten (10) years from the date of the first sale of each product.

 

 

(v)

a royalty of 2% of Net Sales of all Licensed Products covered by a Claim of a Licensed Patent exclusively licensed to the Company hereunder, for a period of ten (10) years from the date of First Sale of each new Licensed Product in a territory or the last to expire Licensed Patent in such territory, whichever is longer.

 

 

(a)

If more than one Licensed Patent covers a Licensed Product, no additional royalties will be paid by Company than if the Licensed Product is covered by one Licensed Patent.

 

 

(b)

If, after review at any stage of prosecution, Company and Columbia amend this agreement in writing that all claims issued or pending either do not cover a Licensed Product, or are deemed unpatentable, then the royalty to Columbia under Section 3a(v) hereof shall be reduced to one percent (1%) of Net Sales on such Licensed Product.  Notwithstanding the foregoing, if a patent subsequently issues from such applications, then the royalty due to Columbia shall return to the original two percent (2%) of Net Sales on such Licensed Product, beginning on the date of such issue.

 

 


 

b.           For the avoidance of doubt, Licensee owes the same royalty to Columbia on Net Sales by a Sublicensee as the royalty Licensee would pay if the sales were made by Licensee itself.  In addition, on all other gross revenues to the extent included in sublicense income as defined above in Section1q (other than royalties on Net Sales), fees, payments and consideration, or any part thereof, re


 
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