Exclusive License Agreement
EXCLUSIVE LICENSE AGREEMENT
THIS AGREEMENT effective January 18th , 2012 (the “Effective Date”) is entered into by and between Amarantus BioSciences, Inc. a Delaware corporation, (“AMBS”), and Power 3 Medical Products, Inc. (“Power 3”). The parties, intending to be legally bound, agree as follows:
SECTION 1 – LICENSE
1.1 Grant of Exclusive License. For the term of this Agreement, Power 3 hereby grants to AMBS an exclusive worldwide license to develop, manufacture, have manufactured, use, market, sell and import medical devices and methods under the Power 3 PK IP, including but not limited to the items of intellectual property detailed on Schedule A hereto, and to use all trademarks and copyrights related to the Power 3 PK IP in furtherance of such activities.
1.1(a) Grant of Non-Exclusive License. For the term of this Agreement, Power 3 hereby grants to AMBS a non-exclusive, royalty-free, fully paid-up world-wide license to Power 3 know-how, patents and patent applications which relate to medical devices and methods for the treatment of Neurodegenerative disease as it relates to Parkinson’s disease.
1.1(b) Definitions.
For purposes of this Agreement:
(1) “Know-How Rights” shall mean all trade secret and other know-how rights in and to all data, information, compositions and other technology (including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing) in existence on the Effective Date controlled by Power 3 or its affiliates or arising thereafter to the extent necessary or useful for AMBS to make, have made, use, develop, sell, exploit or seek regulatory approval to market a composition, a diagnostic or service, or to practice any method or process, at any time claimed or disclosed in any issued patent or pending patent application within the Patent Rights or which otherwise relates to the Technology.
(2) “Patent Rights” shall mean (a) all patents and patent applications in any country of the world that claim or cover the Technology to the extent Power 3 or its affiliates heretofore or hereafter have an ownership or (sub)licensable interest therein, (b) all divisions, continuations, continuations-in-part, that claim priority to, or common priority with, the patent applications described in clauses (a) and (b) above or the patent applications that resulted in the patents described in clauses (a) and (b) above, and (c) all patents that have issued or in the future issue from any of the foregoing patent applications, including utility, model and design patents and certificates of invention, together with any reissues, renewals, extensions, substitutes or additions thereto.
(3) “Power 3 PK IP” shall mean the Patent Rights and the Know-How.
(4) “Power 3 Neurodegenerative disease IP” or shall mean the Patent Rights and Know-How.
(5) “Technology” shall mean compositions, devices, technology, data and information comprising, responsible for, resulting from or relating to use of the biomarkers of the PK IP and Power 3 Neurodegenerative disease IP and the tests of the same for the purpose of measuring such biomarkers, together with all improvements and enhancements thereto, all modifications and derivatives thereof, all products comprising any of the foregoing, and all methods of manufacture and uses of any of the foregoing, as it relates to the PK IP and Power 3 Neurodegenerative disease IP.
1.2 IP Development. All medical devices and all additional intellectual property pertaining to Parkinson’s disease diagnosis, including all additional patents, applications, trademarks, copyrights, inventions, trade secrets, and know-how developed by AMBS or Power 3 during the term of this Agreement relating to or based in whole or in part on the Power 3 PK IP shall be the sole and exclusive property of the developing party. All medical devices and all additional Intellectual Property pertaining to Parkinson’s disease diagnosis conceived or developed by Power 3 during the term of this Agreement, if any, shall be included within the scope of the exclusive license granted hereunder to AMBS.
1.3 Term of Agreement. The initial term of this Agreement shall be 1 year from the date hereof, renewable upon mutual written agreement of the parties.
1.4 Consideration. In consideration for the licenses granted hereunder, the validation studies and technology transfer, AMBS shall issue to Power 3 $500,000 worth of AMBS common stock, priced at the closing price of the common stock on January 23rd, 2012, par value $0.001, in AMBS shares, including a $25,000 exclusivity fee paid to Power 3 upon execution of a non-binding term sheet dated November 11, 2011 and extended on December 31, 2011. Upon completion of a technology transfer of the Power 3 PK IP into a facility designated by AMBS completed to the complete satisfaction of AMBS and transfer of ownership of any and all patents pertaining to Parkinson’s disease diagnosis by way of assignment of all related Power 3 PK IP, AMBS will be required to exercise this Asset Purchase Option as described below in Section 2.
SECTION 2 – ASSET PURCHASE OPTION AND RIGHT OF FIRST REFUSAL
2.1 Asset Purchase Option. At any time until the expiration of the licensing term of this Agreement, AMBS shall have the exclusive option to purchase all of the Power 3 PK IP for a purchase price equal to $500,000 worth of common stock, priced at the closing price of the common stock on January 17th 2012, par value $0.001, in AMBS shares. Within thirty (30) days of AMBS’s written notice to Power 3 that it elects to exercise the purchase option, the purchase shall be concluded by execution of a formal Asset Purchase Agreement containing customary representations and warranties, together with any and all ancillary documentation necessary to affect the sale.
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2.2 Right of First Refusal. For the full term of the Agreement, AMBS shall be granted a Right of First Refusal to acquire the Power 3 Neurodegenerative disease IP, including but not limited to the IP on Schedule D, whereby upon completion of the Phase 2 validation study as described in Schedule B, Power 3 shall be required to negotiate in good faith for the sale of the Power 3 Neurodegenerative disease IP to AMBS for a period of time not to exceed ninety (90 days). Such period may extend beyond the expiration of this Agreement provided that negotiations have begun during the term of this Agreement. In the event AMBS and Power 3 are unable to reach a mutually satisfactory agreement and thereafter Power 3 obtains a bone fide written offer from a third party for the Power 3 Neurodegenerative disease IP, Power 3 shall be required to disclose such offer and its terms to AMBS within five (5) business days and AMBS shall have a right to match said written offer within ten (10) business days. In the event AMBS does not match said offer, Power 3 shall have the right to sell the Power 3 Neurodegenerative disease IP to the third party that made the bona fide offer at the price and on the terms disclosed to AMBS.
SECTION 3 – VALIDATION STUDY AND TECHNOLOGY TRANSFER
3.1 Validation Studies and Technology Transfer. For consideration granted herewith, Power 3 will use good faith efforts to carry out the validation study and technology transfer according to Schedule B. Each month, Power 3 shall make reports in writing to AMBS on the status of the validation studies and technology transfer. During the period of this Agreement, AMBS’s technical/scientific representative and other representatives may have reasonable access to consult informally with Power 3’s technical/scientific representative regarding the validation studies and technology transfer both personally and by telephone.
SECTION 4 – REPRESENTATIONS AND WARRANTIES OF POWER 3
Power 3 hereby represents and warrants to AMBS as follows:
4.1 Organization. Power 3 (i) is duly organized, validly existing and in good standing (or its equivalent) under the laws of the State of New York, (ii) has all licenses, permits, authorizations and other consents necessary to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and (iii) has all requisite corporate or other applicable power and authority to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and presently proposed to be conducted. Power 3 is duly qualified or authorized to conduct business and is in good standing (or its equivalent) as a foreign corporation or other entity in all jurisdictions in which the ownership or use of its assets or nature of the business conducted by it makes such qualification or authorization necessary.
4.2 Authorization; Validity of Agreement. Power 3 has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby. The execution, delivery and performance by Power 3 of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by the Board of Directors of Power 3 and no other action on the part of Power 3 or any of its stockholders or subsidiaries is necessary to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby. This Agreement has been duly executed and delivered by Power 3 and is a valid and binding obligation of Power 3, enforceable against Power 3 in accordance with its terms, except as such enforcement is limited by bankruptcy, insolvency and other similar laws affecting the enforcement of creditors’ rights generally and by general principles of equity.
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4.3 Consents and Approvals; No Violations. Neither the execution, delivery or performance of this Agreement by Power 3 nor the consummation of the transactions contemplated hereby will (i) violate any provision of its certificate of incorporation or by-laws; (ii) violate, conflict with or result in a breach of any provision of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, require the consent of or result in the creation of any encumbrance upon any of the properties of Power 3 or any of its subsidiaries under any material note, bond, mortgage, indenture, deed of trust, license, franchise, permit, lease, contract, agreement or other instrument to which Power 3 or any its subsidiaries or any of their respective properties may be bound; (iii) require any consent, approval or authorization of, or notice to, or declaration, filing or registration with, any governmental entity by or with respect to Power 3 or any of its subsidiaries; or (iv) violate any order, writ, judgment, injunction, decree, law, statute, rule or regulation applicable to Power 3 or any of its subsidiaries or any of their respective properties or assets (See Schedule C).
4.4 The consent of, or the delivery of notice to or filing with, any party to a material contract is not required for the execution and delivery by Power 3 of this Agreement or the consummation of the transactions contemplated under the Agreement.
4.5 Patents and Other Intangible Assets. Power 3 (i) owns, free and clear of all liens, all patents, trademarks, copyrights, inventions, trade secrets, and know-how related to or comprising the Power 3 PK IP, (ii) has not sold or granted to any third party any rights in the Power 3 PK IP, and (iii) has the right to use such intellectual property without infringing upon or otherwise acting adversely to the right of any person under or with respect to any of the foregoing. All of the Power 3 PK IP can and will be licensed by Power 3 to AMBS upon the terms of this Agreement without the consent of any Person other than AMBS.
4.6 Shares To Be Issued To Power 3. With respect to the shares of common stock to be issued to Power 3 as consideration hereunder (the “Shares”), Power 3 represents and warrants to AMBS the following:
(a) Power 3 acknowledges that an investment in the Shares involves a high degree of risk in that AMBS does not currently generate revenue and may require substantial funds to pursue its business plan;
(b) Power 3 recognizes that an investment in the shares is highly speculative and only investors who can afford the loss of their entire investment should consider investing in AMBS and the Shares;
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(c) Power 3 and its officers and directors have such knowledge and experience in finance, securities, investments, including investment in unregistered securities, and other business matters so as to be able to protect its interests in connection with this transaction;
(d) Power 3 is an "Accredited Investor" as defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933, as amended;
(e) Power 3 acknowledges that only a limited market for the Shares presently exists and accordingly Power 3 may not be able to liquidate its investment;
(f) Power 3 acknowledges that the Shares are subject to significant restrictions on transfer as imposed by state and federal securities laws, including but not limited to a minimum holding period of at least six (6) months;
(g) Power 3 hereby acknowledges (i) that this offering of Shares has not been reviewed by the United States Securities and Exchange Commission ("SEC") or by the securities regulator of any state; (ii) that the Shares are being issued by AMBS pursuant to an exemption from registration provided by Section 4(2) of the Securities Act of 1933; and (iii) that the certificate evidencing the Shares received by Power 3 will bear a legend in substantially the following form:
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR UNDER ANY APPLICABLE STATE SECURITIES LAWS. WITHOUT SUCH REGISTRATION, SUCH SECURITIES MAY NOT BE SOLD OR OTHERWISE TRANSFERRED AT ANY TIME WHATSOEVER UNLESS IN THE OPINION OF COUNSEL SATISFACTORY TO THE COMPANY REGISTRATION IS NOT REQUIRED FOR SUCH TRANSFER AND THAT SUCH TRANSFER WILL NOT BE IN VIOLATION OF THE APPLICABLE FEDERAL AND STATE SECURITIES LAWS OR ANY RULE OR REGULATION PROMULGATED THERE UNDER.
(h) Power 3 is acquiring the Shares as principal for Power 3's own benefit;
(i) Power 3 is not aware of any advertisement of the Shares or any general solicitation in connection with any offering of the Shares;
(j) Power 3 acknowledges and agrees that the AMBS has previously made available to Power 3 the opportunity to ask questions of and to receive answers from representatives of AMBS concerning AMBS and the Shares, as well as to conduct whatever due diligence Power 3, in its discretion, deems advisable.
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SECTION 5 – REPRESENTATIONS AND WARRANTIES OF AMBS
AMBS hereby represents and warrant to Power 3 as follows:
5.1 Organization. AMBS (i) is duly organized, validly existing and in good standing (or its equivalent) under the laws of the State of Delaware, (ii) has all licenses, permits, authorizations and other consents necessary to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and (iii) has all requisite corporate or other applicable power and authority to own, lease and operate its properties and assets and to carry on its business as it is now being conducted and presently proposed to be conducted. AMBS is duly qualified or authorized to conduct business and is in good standing (or its equivalent) as a foreign corporation or other entity in all jurisdictions in which the ownership or use of its assets or nature of the business conducted by it makes such qualification or authorization necessary.
5.2 Authorization; Validity of Agreement. AMBS has all requisite corporate power and authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby. The execution, delivery and performance by AMBS of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by the Board of Directors of AMBS and no other action on the part of AMBS or any of its stockholders or subsidiaries is necessary to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby. This Agreement has been duly executed and delivered by AMBS and is a valid and binding obligation of AMBS, enforceable against AMBS in accordance with its terms, except as such enforcement is limited by bankruptcy, insolvency and other similar laws affecting the enforcement of creditors’ rights generally and by general principles of equity.
5.3 Shares To Be Issued To Power 3. With respect to the shares of common stock to be issued to Power 3 as consideration hereunder (the “Shares”), AMBS represents and warrants to Power 3 that, upon issue, the Shares will be duly and validly issued, fully paid and non-assessable common stock in the capital of AMBS.
5.4 Fairness Opinion. Power 3 and AMBS represents that the Parties do not require a fairness opinion to execute this Agreement or transfer the License.
SECTION 6 – INDEMNIFICATION AND RELATED MATTERS
6.1 Indemnification. Power 3 shall indemnify and hold harmless AMBS, and AMBS shall indemnify and hold harmless Power 3, (collectively, the “Indemnified Parties”), and shall reimburse the Indemnified Parties for, any loss, liability, claim, damage, expense (including, but not limited to, costs of investigation and defense and reasonable attorneys’ fees) (collectively, “Damages”) arising from or in connection with (a) any inaccuracy, in any material respect, in any of the representations and warranties made in this Agreement or in any disclosure schedule thereto, or any actions, omissions or statements of fact inconsistent with any such representation or warranty, (b) any failure to perform or comply in any material respect with any covenant or agreement in this Agreement, (c) taxes attributable to any transaction or event occurring on or prior to the date of this Agreement, or (d) any litigation, action, claim, proceeding or investigation by any third party relating to or arising out of the business or operations of the respective parties prior to the date hereof.
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6.2 Survival. All representations, warranties, covenants and agreements of the Parties contained in this Agreement or in any instrument delivered pursuant to this Agreement shall survive the termination of the initial term of this Agreement.
6.3 Notice of Claims.
(a) If an Indemnified Party shall assert a claim for indemnification pursuant to Section 6.1, such Indemnified Party shall submit to the indemnitor a written claim stating: (i) that an Indemnified Party incurred or reasonably believes it may incur Damages and the amount or reasonable estimate thereof of any such Damages; and (ii) in reasonable detail, the facts alleged as the basis for such claim and the section or sections of this Agreement alleged as the basis or bases for the claim.
(b) In the event that any action, suit or proceeding is brought against any Indemnified Party with respect to which a party may have liability under this Section 6, the indemnitor shall have the right, at its cost and expense, to defend such action, suit or proceeding in the name and on behalf of the Indemnified Party; provided, however, that the Indemnified Party shall have the right to retain its own counsel, with fees and expenses paid by indemnitor, if representation of the Indemnified Party by counsel retained by the indemnitor would be inappropriate because of actual or potential differing interests between indemnitor and the Indemnified Party. In connection with any action, suit or proceeding subject to this Section 6, the parties agree to render to each other such assistance as may reasonably be required in order to ensure proper and adequate defense of such action, suit or proceeding. An indemnitor shall not, without the prior written consent of the applicable Indemnified Parties, which consent shall not be unreasonably withheld or delayed, settle or compromise any claim or demand if such settlement or compromise does not include an irrevocable and unconditional release of such Indemnified Parties for any liability arising out of such claim or demand.
SECTION 7 – TERM AND TERMINATION
7.1 This Agreement shall expire 1 year from its date of execution unless extended or sooner terminated in accordance with the provision of this section.
7.2 Either party may terminate this Agreement on the anniversary date by giving the other party sixty (60) days prior written notice of its election to terminate.
7.3 If Power 3 fails to timely meet its obligations under Section 3 and shall fail to remedy these failures within thirty (30), ABMS may terminate this Agreement upon thirty (30) days written notice. Upon termination, Power 3 shall immediately return, without further consideration, all common stock issued to Power 3 under the terms of this Agreement.
7.4 No rights or obligations survive termination of this Agreement.
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SECTION 8 – NOTICES
All notices, requests, demands, claims, and other communications hereunder shall be in writing. Any notice, request, demand, claim or other communication hereunder shall be deemed duly delivered four business days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one business day after it is sent for next business day delivery via a reputable nationwide overnight courier service, in each case to the intended recipient as set forth below:
If to Power 3:
Power 3 Medical Products, Inc.
ATTN: Helen R. Park, M.S.
26202 Oakridge Dr. A-102
The Woodlands, TX 77380
If to AMBS:
Amarantus BioSciences, Inc.
Attn: Gerald Commissiong
675 Almanor Ave.
Sunnyvale, CA 94085
SECTION 9 – MISCELLANEOUS
9.1 Amendments. Subject to applicable law, this Agreement may be amended or modified by the parties hereto only by written agreement executed by each party to be bound thereby and delivered by duly authorized officers of the parties hereto.
9.2 Entire Agreement. This Agreement and the exhibits attached hereto or referred to herein constitute the entire agreement of the parties hereto, and supersede all prior agreements and undertakings, both written and oral, among the parties hereto, with respect to the subject matter hereof and thereof.
9.3 Severability. If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any rule of law or public policy, all other conditions and provisions of this Agreement will nevertheless remain in full force and effect so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto will negotiate in good faith to amend or modify this Agreement so as to effect the original intent of the parties as closely as possible in an acceptable manner to the end that transactions contemplated hereby are fulfilled to the extent possible.
9.4 Successors and Assigns; Assignment. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned or delegated by any of the parties hereto without the prior written approval of all parties.
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9.5 No Third Party Beneficiaries. Nothing herein expressed or implied shall be construed to give any person other than the parties hereto (and their successors and assigns as permitted herein) any legal or equitable rights hereunder.
9.6 Counterparts; Delivery by Facsimile. This Agreement may be executed in multiple counterparts, and by the different parties hereto in separate counterparts, each of which when executed will be deemed to be an original but all of which taken together will constitute one and the same agreement. This Agreement and each other agreement or instrument entered into in connection herewith or therewith or contemplated hereby or thereby, and any amendments hereto or thereto, to the extent signed and delivered by means of a facsimile machine or by electronic mail, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. At the request of any party hereto or to any such agreement or instrument, each other party hereto or thereto shall re-execute original forms thereof and deliver them to all other parties. No party hereto or to any such agreement or instrument shall raise the use of a facsimile machine or electronic mail to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of a facsimile machine or electronic mail as a defense to the formation or enforceability of a contract and each such party forever waives any such defense.
9.7 Governing Law. This Agreement and the agreements, instruments and documents contemplated hereby shall be governed by and construed and enforced in accordance with the laws of the State of Nevada without regard to its conflicts of law principles.
8.8 Interpretation.
(a) When a reference is made in this Agreement to a section or article, such reference shall be to a section or article of this Agreement unless otherwise clearly indicated to the contrary.
(b) Whenever the words “include”, “includes” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.”
(c) The words “hereof”, “hereby”, “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement, and article, section, paragraph, exhibit and schedule references are to the articles, sections, paragraphs, exhibits and schedules of this Agreement unless otherwise specified.
(d) The words “knowledge,” or “known to,” or similar terms, when used in this Agreement to qualify any representation or warranty, refer to the knowledge or awareness of certain specific facts or circumstances related to such representation or warranty of the persons in the Applicable Knowledge Group (as defined herein) which a prudent business person would have obtained after reasonable investigation or due diligence on the part of any such person. For the purposes hereof, the “Applicable Knowledge Group” with respect to AMBS shall be Gerald Commissiong. For the purposes hereof, the “Applicable Knowledge Group” with respect to Power 3 shall be Ira L. Goldknopf, Ph.D.
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(e) The word “subsidiary” shall mean any entity of which at least a majority of the outstanding shares or other equity interests having ordinary voting power for the election of directors or comparable managers of such entity is owned, directly or indirectly by another entity or person.
(f) For purposes of this Agreement, “ordinary course of business” means the ordinary course of business consistent with past custom and practice (including with respect to quantity and frequency).
(g) The plural of any defined term shall have a meaning correlative to such defined term, and words denoting any gender shall include all genders. Where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning.
(h) A reference to any legislation or to any provision of any legislation shall include any modification or re-enactment thereof, any legislative provision substituted therefor and all regulations and statutory instruments issued thereunder or pursuant thereto, unless the context requires otherwise.
(i) The parties hereto have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed on the date first written above.
| Amarantus BioSciences, Inc. | ||
| By: | /s/ Gerald Commissiong | |
| Name: | Gerald Commissiong | |
| Title: | President & CEO | |
| Power 3 Medical Products, Inc. | ||
| By: | /s/ Helen R. Park | |
| Name: | Helen R. Park, M.S. | |
| Title: | Interim CEO | |
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Schedule A – Power 3 Parkinson’s Disease Diagnostic IP
The Power 3 PK IP shall include of all of Power 3’s right title and interest in and to the intellectual property rights set forth herein below, as they relate to Parkinson’s disease diagnosis, including without limitation: (a) the patents, patent applications, and any inventions set forth below (collectively, the "Patents"); (b) all rights to apply in any or all countries of the world for patents or governmental grants in such Patents; (c) any and all applications filed and any and all patents, certificates of inventions or other governmental grants granted on said Patents in the United States or any other country, including each and every application filed and each and every Patent granted on any applications which is a division, substitution or continuation of any of said applications; (d) each and every reissue or extension of any of such Patents; (e) each any every patent claim resulting from a reexamination certificate for any and all such Patents; and (f) any and all rights to sue for and recover damages for any past, present or future violation, misappropriation or infringement of the Patents.
| Title of Patent, Patent Application, or Invention | Jurisdiction | Application/Priority |
| Diagnosis of Parkinson’s Disease | US | 12/802,630; 06/10/2009 |
| Assays for diagnosis and therapeutics employing similarities and differences in blood serum concentrations of 3 forms of complement C3C and related protein biomarkers between Amytrophic Lateral Sclerosis and Parkinson's disease | US | 13/118,175; 08/24/2005 |
| Forty Seven (47) Protein Biomarkers For Neurodegenerative Diseases | US | 12/069,807; 2/13/2008 |
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Schedule B
Timeline for PD Technology Transfer and Development
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Summary of Steps
IP exchange
Patent Applications Exchange
SOP exchange
Lists
Equipment and supplies
Personnel requirements
Training
Training manual
In-house at P3 training
Training at Amarantus approved site
Qualification
P3 & Am side by side testing
Certification
Release of PD diagnostic test to Amarantus
Clinical Trials
Finish Phase II
Configuration for target market
Phase III
Future Options
CLIA testing with Gel system
ELISA development
CLIA testing ELISA
Partner mid to large diagnostic company
FDA approval for Gel system
FDA approval for ELISA
FDA partnering with diagnostic company
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Monthly Timeline
Month one P3 - $50,000
IP exchange
IP discussions
SOP’s
Personnel
Lab Tec full
PhD 1/3
Consultant ½
Supplies
Gels
Other chemicals
Calibration
Freezer
Water system
Spectrophotometer
Imager
Computer program updates
PDQUEST®
SAS®
Analyze-It®
Training manual transfer
Contact clinical site for initial samples PK and control samples
IP attorney
Equipment List and contact information transfer
Supply list
Vendor list with contact information
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Month one AM
Receive IP info transfer-consult with IP attorney for prosecution needed
Read and analyze SOPs-questions
Lease lab space
Decide location of lab space
Contract lab work
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Month Two P3 - $40,000
Personnel
Lab Tech full
PhD 1/3
Consultant ½
Imaging training new personnel 1/3 time
SAS analysis training new personnel 1/3 time
Supplies
Re run samples on new gels/stain/de-stain/image
Albumin standards 12 gels
Pools
PD
PD like
Control (age/sex matched)
Qualify Results
Samples from Phase I (triplicate)
5 PD
5 PD like
5 Age matched controls
Qualify Results
Samples from Phase II (triplicate)
25 samples PD
25 samples PD like
25 samples control
Qualify Results
Validation for method restart complete when criteria met:
Image quality
Accuracy
Reproducibility
Robustness
Linearity
Dynamic range
Limit of detection
Limit of quantify ability
Plan for next phases samples with Amarantus
Contract and IRB Protocol for new clinical site for prospective samples
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Month Two-Three AM
Set up lab at AM designated site
Order equipment
2D Gel equipment
Spectrophotometer
Imager
Hood
Refrigerators
Solution storage
Working sample storage
Freezer -20°C
Freezer -80°C
Water system – high quality
Biohazard container and pickup contract
Miscellaneous
Order supplies
Reagents
Miscellaneous
Employ qualified personnel
Project manager
Lab manager
Lab tech
Image analysis
Bioinformatics
Purchase computers
Purchase PDQUEST® program
Purchase SAS® program
Procure source for new samples
Month Two P3 and AM
Develop plan for continuation of clinical trial for PD
disease diagnosis
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Month Three-Five P3 - $40,000
Begin running samples for clinical trials-continue Phase II
50 new PD prospective samples
50 new PD like prospective samples
50 new prospective control samples
Evaluate SAS generated results
Begin training AM personnel at P3
LT full
PhD ½
Consultant ½
Image Tech
SAS consultant 1/3
Supplies
Send initial samples (Set 1) from phase I and standard pools to AM
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Month Four AM Train at P3 - $40,000
Visit P3
Train for protein analysis
Train use of spectrophotometer
Standard curve with Standard albumin
Train for 2D gels
Train image Tech
SAS program set up and initial training
Qualify training of AM Personnel
Albumin standards 12 gels
Pools
PD
PD like
Control (age/sex matched)
Qualify Results
Samples from Phase I (triplicate)
5 PD
5 PD like
5 Age matched controls
Qualify Results
Samples from Phase II (triplicate)
25 samples PD
25 samples PD like
25 samples control
Qualify Results
Validation for method transfer complete when criteria met:
Image quality
Accuracy
Reproducibility
Robustness
Linearity
Dynamic range
Limit of detection
Limit of quantify ability
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Month Six-Twelve P3
Continue clinical sample testing and analysis
Start Phase III clinical trial
500 PD
500 PD like
500 Age matched
Personnel
LT full
Asst lt full
PhD full
Image tech
Consultant ½
SAS consultant full
Clerk
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Month Five AM
Train and qualify at AM facility
Albumin standards 12 gels
Pools
PD
PD like
Control (age/sex matched)
Qualify Results
Samples from Phase I (triplicate)
5 PD
5 PD like
5 Age matched controls
Qualify Results
Samples from Phase II (triplicate)
25 samples PD
25 samples PD like
25 samples control
Qualify Results
Validation for method transfer complete when criteria met:
Image quality
Accuracy
Reproducibility
Robustness
Linearity
Dynamic range
Limit of detection
Limit of quantify ability
Send results to P3
Pass this set vs. results of AM at P3 and P3 at P3
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Month Six-Eight AM
Begin running samples for clinical trials-continue Phase II
50 new PD prospective samples
50 new PD like prospective samples
50 new prospective control samples
Evaluate SAS generated results
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Month Nine-Fifteen AM
Receive clinical trial samples
Start Phase III clinical trial Testing at AM
Compare results for validation with Power 3 results
Month Thirteen P3
Start Preparation for Commercialization with Am
Month Sixteen AM
Continue Phase III
If everything validates
Tech transfer complete
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Timeline
Six Month timeline Cost
- Month 1 Lab startup $50,000
- Month 2 Requalification $40,000
- Month 3 Continue Phase II $40,000
- Month 4 Continue Phase II $40,000
- Month 5 Continue Phase II $50,000
- Month 6 Begin Phase III $65,000
Total $285,000
This is for Power 3’s portion of the time line.
This is a laboratory use of funds only. No new equipment. For intrinsic cost without a detailed budget, it might be better to estimate a budget of $300,000 to $500,000.
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Schedule C
Legal Opinion related to legal claim with Transgenomics
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January 6, 2012
VIA EMAIL ***@***
Helen R. Park
Power3 Medical Products, Inc.
26202 Oak Ridge Drive, Suite A-I 02
Spring, TX 77380
Re: Transgenomic, Tne. v. Power3 Medical Products, Tnc.
Case No: 10-cv-79
Our File No. 12543-0
Dear Helen:
Pursuant to your request, this letter addresses the litigation status between Power3 Medical Products, Inc. and Transgenomic, Inc. in the case captioned Transgenomic. Tnc. v. Power3 Medical Products. Inc., Case No.: lO·cv-79, in the U.S. District Court for the District for Nebraska (the "Litigation").
After a July 20 II mediation, the parties to the Litigation reached a Settlement and Mutual Release Agreement that was executed in August 2011. On October 12, 2011, the Court entered an Order dismissing the Litigation with prejudice.
Please let me know if you have any questions regarding the Litigation.
Sincerely,
/s/ Kristin M.V. Farwell
Kristin M.V. Farwell
KMF/jlm
cc: Gregory C. Scaglione
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Schedule D
Neurodegenerative Disease IP
| 28 |
Power3 Medical Products, Inc.
Neurodegenerative IP List
| PATENT | NUMBER |
| Diagnosis of Parkinson's Disease | 12/802,630
|
| Assays for ALS and ALS-Like Disorders | 12/804,868
|
| Assays for diagnosis and therapeutics employing similarities and differences in blood serum concentrations of 3 forms of complement C3C and related protein biomarkers between Amytrophic Lateral Sclerosis and Parkinson's disease | 131118,175
|
| Diagnosis of Alzheimer's Disease | 13/153,669
|
| Diagnosis of Multiple Forms of Alzheimer's Disease Based on Difference in Concentration of Protein Biomarkers in Blood Serum of Patients | 12/217,885
|
| Forty Seven (47) Protein Biomarkers For Neurodegenerative Disease | 12/069,807
|
| TRADEMARK | |
| NeuroPro and Design | 76/605,921
|
Confidential Information 26202 Oakridge, DR. Suite A-102, Spring, TX 77380
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