EXCLUSIVE LICENSE AGREEMENT

a.  

Affiliate  shall mean, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of the definition, the word "control" (including, with correlative meaning, the terms "controlled by" or "under the common control with") means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.

b.  

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 Disclosing Party to the receiving party (the "Recipient").  Notwithstanding the foregoing, information or materials which are orally or visually disclosed to Recipient by Disclosing Party, or are disclosed in writing or other tangible form without an appropriate letter, proprietary stamp or legend, shall constitute Confidential Information if Disclosing Party, within thirty (30) days after such disclosure, delivers to 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 Recipient to whom such disclosure was made.

c.  

Designative Representatives shall mean employees, consultants and advisors of the Parties or any Affiliate thereof to whom Confidential Information is disclosed only on a “need-to-know” basis and who are directed and required to both maintain the disclosed Confidential Information in strict confidence and exclusively use such Confidential Information solely for the purposes expressly permitted under this Agreement.

d.  

Field shall mean all fields of use.

e.  

First Commercial Sale shall mean the first sale of a Licensed Product by Omnimmune or an Affiliate or sublicensee of Omnimmune to a Third Party in a country following regulatory approval of such Licensed Product in that country or, if no such regulatory approval or similar marketing approval is required, the date upon which such Licensed Product is first commercially launched in such country.

f.  

IND shall mean an application submitted to a regulatory authority to initiate human clinical trials, including (1) an Investigational New Drug application or any successor application or procedure filed with the FDA or any foreign equivalent thereof, and (2) all supplements and amendments that may be filed with respect to the foregoing.

g.  

In Vitro Diagnostic 510(k) shall mean a premarket notification submission to the United States ("US") Food and Drug Administration (FDA) or similar governmental agency in jurisdictions other than the US.  The submission must provide evidence that the device is accurate, safe, effective and substantially equivalent to a device legally marketed in the United States.

h.  

In Vitro Diagnostic Clinical Study shall mean in order to demonstrate clinical use as an aid in cancer detection, evaluations of hCG antibodies, hCG genes or gene products to demonstrate that hCG as a tumor marker is a significant indicator of the presence of cancerous cells.

i.  

In Vitro Diagnostic Compilation and Submission of a 510(k) shall mean a premarket notification or application submitted to the FDA or similar governmental agency in jurisdictions other than the US, the purpose of which is to demonstrate that the medical device to be marketed is substantially equivalent (SE) to a legally marketed device that was or is currently on the U.S. market.  The manufacturer may not place their device into U.S. commerce until they receive a marketing clearance/SE letter from the FDA.

j.  

Improvements shall mean any improvement, addition, enhancement, modification, development, invention, alteration and/or technical advance or other discovery, whether patentable or not, the exploitation of which is dependent on or would infringe (but for a license thereto by IGR or IGR&D (as the case may be)) at least one Valid Claim contained in the Licensed Patents.

k.  

Licensed Information shall mean know-how, research and development, analyses, notes and other such records, procedures, assay and other methods, formulae, indices, techniques, drawings, improvements, software code, algorithms, data management or interpretive systems, processes, protocols, genetic or other libraries, designs, concepts, models, inventions, discoveries, copyrights, trade secrets and other intellectual property, whether proprietary or not, including, without limitation, data generated in pre-clinical and clinical studies, relating to the Licensed Technology, along with any and all documents and other records (electronic or otherwise) relating thereto, including, without limitation, any and all results of   experiments, clinical trials and studies relating to the claims made in the Licensed Patents, and owned by IGR or any Affiliate thereof or to which IGR or any Affiliate thereof may have any rights of use.

l.  

Licensed Material shall mean the tangible or physical materials necessary for the effective exercise of the Licensed Patents or any other uses and such other materials as are routinely produced through use of the original materials, including, without limitation, the materials listed on Attachment A hereto and any and all other cell lines, samples, primers, monoclonal antibodies, reagents, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods) and any other materials relating to the Licensed Patents, together with any progeny, mutants and unmodified derivatives thereof, and owned by IGR&D or any Affiliate thereof or to which IGR&D or any Affiliate thereof may have any rights of use.

m.  

Licensed Patents shall mean the following United States patents:  US 6194154 entitled “Malignant human cell transformation detection method” claiming the priority date March 4, 1996, from the French patent application FR9602683, and US 6514708 entitled “Process for detecting the malignant transformation of human cells” claiming the priority date March 4, 1996, from the French patent application FR9602683 (the “Original Licensed Patents”), and any and all patent applications and patents issued thereon in connection with any and all Improvements, and

n.  

Licensed Process shall mean any process, service, formulae, algorithm, data management or other systems, methodology or similar capability that is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Licensed Patents, including, without limitation, the process or methodology for detecting malignant transformation of human cells and its applications for diagnosing and monitoring cancer patients and for developing cancer prognosis.

o.  

Licensed Product shall mean any product or part thereof that (1) is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Licensed Patents in the country in which any such product or part thereof is made, used or sold; (2) is manufactured by using a process that is covered in whole or in part by an issued, unexpired claim or a pending claim contained in the Licensed Patents, in any country in which any such process is used or in which any such product is used or sold or (3) is developed or manufactured from the Licensed Material or Licensed Information, but which is not covered under clauses (1) and (2) above.

p.  

Licensed Technology  shall mean the Licensed Patents, Licensed Information and Licensed Materials, along with the Licensed Products and Licensed Processes, and any and all Improvements thereon.

s.  

Phase I Study shall mean a study of a product in human volunteers or patients, the purpose of which is the preliminary determination of safety and tolerability of a dosing regime and for which there are no primary endpoints (as recognized by FDA) in the protocol relating to efficacy.

t.  

Phase II Study shall mean (1) a dose exploration, dose response, duration of effect, kinetics, dynamic relationship or preliminary efficacy and safety study of a product in the target patient population, or (2) a controlled dose ranging clinical trial to evaluate further the efficacy and safety of a product in the target patient population and to define the optimal dosing regimen.

u.  

Phase III Study shall mean a controlled pivotal clinical study of a product that is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to obtain regulatory approval to market such product.

v.  

Sublicense Revenue shall mean, except as otherwise provided herein, all amounts actually received by Omnimmune or any Affiliate thereof (if such Affiliate is the sublicensor under a sublicense) from a sublicensee on account of the sublicensing of all or any part of the Licensed Technology, including, without limitation, all sublicense fees, royalties, milestone payments and other fees or payments; provided , however , that Sublicense Revenue shall not include any amounts constituting (1) bona fide research and development funding, such as NIH or other grants, directly relating to potential Licensed Products or Licensed Processes, as reflected in the recipient's books and records in accordance with generally accepted accounting principles, including allocations for overhead and general and administrative costs, and (2) amounts reimbursed by a Third Party for payments for bona fide research and development activities directly relating to potential Licensed Products or Licensed Processes, as reflected in the recipient's books and records in accordance with generally accepted accounting principles including allocations for overhead and general and administrative costs.

w.  

Territory shall mean worldwide.

x.

Third Party   shall mean any entity other than the Parties to this Agreement and their respective Affiliates.

y.  

Transfer Pricing Amounts shall mean prices used in the transfer of materials between units or Affiliates or Sublicensees of the same company, at cost or cost plus transportation costs and only if this transfer does not result in a consumption, destruction or loss of activity of the Licensed Product.

z.  

2.  

License Grant

a.  

Exclusive License .  Subject to the terms and conditions of this Agreement, IGR&D grants to Omnimmune and any Affiliate thereof, an exclusive license in the Territory for the term of this Agreement to use the Licensed Patents, Licensed Material and Licensed Information (along with Improvements thereon), directly and indirectly, to invent, characterize, select, discover, make, develop, manufacture, use, sell, rent, lease, distribute, import, export or otherwise use the Licensed Products, and to practice and permit the practice of the Licensed Processes in the Field, with rights to sublicense to Third Parties.

b.  

Representations and Warranties .  Each of IGR and IGR&D represents and warrants that, except as otherwise provided in this Agreement, (1) it has not transferred by license or otherwise any rights in the Licensed Technology to any Person, (2) that each has the power and authority to enter into, deliver and perform its obligations under this Agreement, and (3) it has not knowingly taken any action or omitted to take any action that would result in the invalidity, reduction in scope or abandonment of any of the Licensed Patents.  Each of IGR and IGR&D further covenants that it will not knowingly or intentionally take or omit to take any of the actions described in the immediately preceding sentence.

c.  

Access to Licensed Information and Licensed Material .  During the term of this Agreement, each of IGR and IGR&D, as applicable, shall provide as soon as reasonably practicable, but in no event later than ten (10) business days following the Effective Date, Omnimmune with (1) all Licensed Information and Licensed Materials, and (2) a reasonable opportunity to discuss the Invention with IGR's research personnel.  Each of IGR and IGR&D shall have a continuing obligation during the term of this Agreement to supplement such disclosures to Omnimmune with current information and materials relating directly to the Licensed Patents, including any Improvements to Licensed Patents.  Omnimmune shall provide each of IGR and IGR&D with a Federal Express account number or an account number for another courier service, so that IGR or IGR&D, as applicable, may ship the Licensed Material to Omnimmune.

d.  

Sublicensing Rights .  For the term of this Agreement, IGR&D grants to Omnimmune the right to grant sublicenses of the Licensed Technology to Third Parties in the Field and throughout the Territory; provided , however , that (1) the sublicensee shall have agreed that any right granted thereto pursuant to this Subsection shall be subject to the terms and conditions of this Agreement, including, without limitation, Section 16(d) below; (2) Omnimmune will provide promptly IGR&D with information of any grant of any such sublicense and will provide to IGR&D, upon IGR&D’s request, a copy of any sublicense agreement; provided, that Omnimmune's obligation to provide a copy of any such sublicense shall be subject to applicable confidentiality obligations of Omnimmune, and any sublicense provided to IGR&D shall constitute Omnimmune Confidential Information; and (3) no such sublicense shall relieve Omnimmune of its obligations under this Agreement.

3.  

Royalties and Other Payments .

b.  

License Maintenance Fees .  An annual license maintenance fees according to the schedule below:

(A) 

At the commencement of an In Vitro diagnostic Clinical Study: Two thousand five hundred euro (2,500€);

(B)  

Upon compilation and Submission of a 510(k) authorization or equivalent thereto: Five thousand euro (5,000€); and

(C)  

At the First Commercial Sale following the 510(k) authorization or equivalent thereto:  Twelve thousand euro five hundred euro (12,500€) if the First Commercial Sale is in the United States of America (“USA”).

(i)  

At the first entrance in Phase II Clinical Trial:  Twenty five thousand euro (25,000€);

(ii)  

At the first entrance in Phase III Clinical Trial: Seven