Exhibit 10.45


 


EXCLUSIVE LICENSE AGREEMENT


 


This Agreement is made
and is effective this 11th day of July 2005 (the "Effective Date") between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
("The Regents"), a California corporation having its corporate offices located at 1111 Franklin Street, Oakland, California
94607-5200, acting through its offices located at 10920 Wilshire Blvd, Suite 1200, Los Angeles, California 90024-1406, and General
Fiber, Inc ("Licensee"), a corporation having a principal place of business at 801 Brickell Avenue, 9th Floor,
Suite 942, Miami, FL 33131.


 


RECITALS


 


WHEREAS, a certain invention
(the "Invention"), generally characterized as "Estriol for the treatment of autoimmune diseases & the use of
estriol and other estranges, estrogens and estrogen receptor active compositions in the treatment of psoriasis & other autoimmune
diseases" (UCLA Case No. 1998-531 & UCLA Case No. 2004-101) made in the course of research at the University of California,
Los Angeles and Irvine by Drs. Rhonda Voskuhl, Jenny Murase, and Gerald Weinstein), and claimed in Regents' Patent Rights as defined
below;


 


WHEREAS, Drs.
Voskuhl, Murase, ~and Weinstein are an employees of The
Regents and as such are obligated to assign their right, title and interest in and to the Invention to The Regents; 


 


WHEREAS, the Invention
was developed with United States Government funds, and The Regents has elected title thereto and granted a royalty-free nonexclusive
license to the United States Government on 11-14-97, as required under 35 U.S.C. §200-212;


 


WHEREAS, Licensee and The
Regents entered into a Secrecy Agreement effective 10-20-03 and expiring on 10-20-08 to allow Licensee to evaluate its interest
in the Invention and, as a result of its evaluation, Licensee wishes to obtain certain rights from The Regents;


 


WHEREAS, Licensee is a
"small business concern" as defined in 15 U.S.C. §632; and


 


WHEREAS, The Regents wishes
that Regents' Patent Rights be developed and utilized to the fullest extent so that the benefits can be enjoyed by the general
public.


 


The parties agree as follows:


 


1. DEFINITIONS


 


1.1
"Regents' Patent Rights" means The Regents interest in any of the patent applications listed in Appendix A attached
to this Agreement and assigned to The Regents (UCLA Case No. 1998-531 & UCLA Case No. 2004-101); any continuing applications
thereof including divisions; but excluding continuations-in-part except to the extent of claims entirely supported in the specification
and entitled to the priority date of the parent application; any patents issuing on these applications including reissues and reexaminations;
and any corresponding foreign patents or patent applications; all of which will be automatically incorporated in and added to Appendix
A and made a part of this Agreement.


 






    	 



    	 



    

 


1.2 "Licensed
Product" means any article, composition, apparatus, substance, chemical, or any other material covered by Regents' Patent
Rights or whose manufacture, use or sale would constitute an infringement of any claim within Regents'
Patent Rights, or any service, article, composition, apparatus, chemical, substance, or any other material made, used, or sold
by or utilizing or practicing a Licensed Method. This definition of Licensed Product also includes a service either used by Licensee,
an Affiliate, or sublicensee or provided by Licensee, an Affiliate or sublicensee to its customers when such service requires the
use of Licensed Product or performance of Licensed Method. Additionally, for the avoidance of doubt, if such product is a component
of a larger unit such as a kit, composition of matter or combination, such kit, composition of matter or combination is deemed
to be the Licensed Product for purposes of this definition. 


 


1.3
"Licensed Method" means any process or method which is covered by Regents' Patent Rights or whose use or practice
would constitute an infringement of any claim within Regents' Patent Rights.


 


1.4
The "Field of Use" means all fields for the first two years after the Effective Date of the Agreement. On the second
anniversary of the Effective Date of the Agreement Licensee will select fields of use and for each field will be required to meet
the diligence terms outlined in paragraph 6.3 below.


 


1.5
"Affiliate" means any corporation or other business entity in which Licensee owns or controls, directly or indirectly,
at least 50% of the outstanding stock or other voting rights entitled to elect directors. In any country where the local law does
not permit foreign equity participation of at least 50%, then "Affiliate" means any company in which Licensee owns or
controls, directly or indirectly, the maximum percentage of outstanding stock or voting rights that is permitted by local law.


 


1.6
"First Commercial Sale" means the first sale of any Licensed Product by Licensee or any Affiliate or Sublicensee,
following approval of it's marketing by the appropriate governmental agency for the country in which the sale is to be made. When
governmental approval is not required, "First Commercial Sale" means the first sale in that country.


 


1.7
"Final Sale" means any sale, transfer, lease, exchange or other disposition or provision of a Licensed Product and/or
a Licensed Method to a Customer. A Final Sale shall be deemed to have occurred upon the earliest to occur of the following (as
applicable): (a) the transfer of title to such Licensed Product and/or Licensed Method to a Customer, (b) the shipment of such
Licensed Product to a Customer, (c) the provision of a Licensed Method to a Customer, (d) the provision of an invoice for such
Licensed Product or Licensed Method to a Customer, or (e) payment by the Customer for Licensed Products or Licensed Methods.


 


1.8
"Net Sales" means the total of the gross amount invoiced or otherwise charged (whether consisting of cash or any
other forms of consideration) for the Final Sale of Licensed Products or Licensed Methods by Licensee, or by any Affiliate, Joint
Venture or Sublicensee to Customers, less the following deductions (to the extent included in and not already deducted from the
gross amount invoiced or otherwise charged) to the extent reasonable and customary: cash, trade or quantity discounts actually
granted to Customers; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (excepting value
added taxes or income taxes); transportation charges, including insurance to the extent actually paid by the Customer; and allowances
or credits to Customers because of rejections or returns. Where Licensee or any Affiliate, Joint Venture or Sublicensee is the
Customer, then Net Sales shall be based on the gross amount normally invoiced or otherwise charged to other Customers in an arms
length transaction for such Licensed Products or Licensed Methods. For the avoidance of doubt, if Licensee or any Affiliate, Joint
Venture or Sublicensee supplies (directly or indirectly) a Product that constitutes a 8-Jul-05 Licensed
Product to any Affiliate, Joint Venture or Sublicensee and such Affiliate, Joint Venture or Sublicensee includes such Product in
another Product, then Net Sales shall be based on the total gross amount invoiced or otherwise charged for such other Product in
its entirety. If License pays a third party royalties in consideration for patent rights which are necessary in order to practice
Regents' Patent Rights then Licensee or Sublicensee, as the case may be may deduct .333% from the royalty rate due to The Regents
under this Agreement for every percentage point paid to third party in royalties, provided that in no event shall royalties or
other amounts due to The Regents in any reporting period be reduced to less than 50% of what would otherwise be due to The Regents.



 






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1.9
"Sublicensee" means any third party sublicensed by Licensee to make, have made, use, sell, offer for sale or importany
Licensed Product or to practice any Licensed Method.


 


1.10
"Sublicensing Income" means income received by Licensee under or on account of Sublicenses. Sublicensing Income includes
income received by way of license issue fees, milestone payments, and the like but specifically excludes royalties on the sale
or distribution of Licensed Products or the practice of Licensed Methods. Not included in the definition of Sublicensing Income
is income received by Licensee as payment or reimbursement for research costs conducted by or for Licensee, including costs associated
with materials, equipment or clinical testing and amounts received in connection with the issuance of debt or equity.


 


1.11
"Customer" means any individual or entity that receives Licensed Products or Licensed Methods, provided however,
that Licensee or any Affiliate, Joint Venture or Sublicensee shall be deemed a Customer only if it receives Licensed Products or
Licensed Services for its own end-use and not resale.


 


2. GRANT


 


2.1
Subject to the limitations set forth in this Agreement, The Regents hereby grants to Licensee an exclusive license (the "License")
under Regents' Patent Rights, in jurisdictions where Regents' Patent Rights exist, to make, have made, use, sell, offer for sale
and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law.


 


2.2
The License is subject to all the applicable provisions of any license to the United States Government executed by The Regents
and is subject to any overriding obligations to the United States Federal Government under 35 U.S.C. §§200-212 and applicable
governmental implementing regulations.


 


2.3
The Regents expressly reserves the right to use Regents' Patent Rights and associated technology for educational and research
purposes including publication of research results and sharing research results with other non-profit institutions, and allowing
other non-profit research institutions to use Regents' Patent Rights and associated technology for the same purpose.


 


3. SUBLICENSES


 


3.1
The Regents also grants to Licensee the right to issue exclusive or nonexclusive sublicenses ("Sublicenses") to third
parties to make, have made, use sell, offer for sale or import Licensed Products and to practice Licensed Methods in any jurisdiction
in which Licensee has exclusive rights under this Agreement. To the extent applicable, sublicenses must include all of the rights
of and obligations due to The Regents (and, if applicable, the U.S. Government under 35 U.S. C. §§201-212) contained
in this Agreement.


 


3.2
Licensee must pay to The Regents 25% of all Sublicensing Income.


 


3.3
On Net Sales of Licensed Products sold or disposed of by a Sublicensee, Licensee must pay to The Regents an earned royalty
in accordance with Article 5 (Royalties) as if these were Licensee's Net Sales. Any royalties received by Licensee in excess of
royalties due to The Regents under this Paragraph 3.3 belong to Licensee.


 






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3.4
Licensee must provide to The Regents a copy of each Sublicense within 30 days of execution,
and a copy of all information submitted to Licensee by Sublicensees relevant to the computation
of the payments due to The Regents under this Article 3. 


 


3.5
If this Agreement is terminated for any reason, all outstanding Sublicenses, not in default, will be assigned by Licensee to
The Regents, at the option of The Regents. The Sublicenses will remain in full force and effect with The Regents as the licensor
or sublicensor instead of Licensee, but the duties of The Regents under the assigned Sublicenses will not be greater than the duties
of The Regents under this Agreement, and the rights of The Regents under the assigned Sublicenses will not be less than the rights
of The Regents under this Agreement, including all financial consideration and other rights of The Regents.


 


4. FEES


 


4.1
In partial consideration for the License, Licensee will pay to The Regents a license issue fee of twenty thousand dollars ($20,000)
within 30 days of the Effective Date and twenty five thousand dollars ($25,000) on the first anniversary of this Agreement. This
fee is nonrefundable and is not an advance against royalties.


 


4.2
For each Licensed Product reaching the milestones indicated below, Licensee must make the following payments to The Regents
within 30 days of reaching the milestones:


 





	 	4.2a	One hundred thousand dollars ($100,000) upon the NDA filing with the U.S. Food and Drug Administration which is covered by a validly issued U.S. patent.
	 	 	 
	 	4.2b	Six hundred fifty thousand dollars ($650,000) upon approval of an NDA with the U.S. Food and Drug Administration which is covered by a validly issued U.S. patent 


 


4.3
Licensee must pay to The Regents a license maintenance fee of $ 5,000 beginning on the one-year anniversary date of the Effective
Date of this Agreement and continuing annually on each anniversary date of the Effective Date. The maintenance fee will not be
due and payable on any anniversary date of the Effective Date if on that date Licensee is commercially selling a Licensed Product
and paying an earned royalty to The Regents on the sales of that Licensed Product. The license maintenance fees are non-refundable
and are not an advance against royalties.


 


4.4
In the event that the Licensee is publicly traded, Licensee shall make, at The Regents' election, payment under sections 4.1,
4.2 & 4.3 with Licensee's publicly traded equity.


 


5. ROYALTIES


 


5.1
Licensee must pay to The Regents for sales by Licensee or its Affiliates an earned royalty of four percent (4%) of Net Sales
of Licensed Products or Licensed Methods unless reduced pursuant to Section 1.8.



 


5.2
Licensee must pay to The Regents a minimum annual royalty of $10,000 for the life of Regents' Patent Rights, beginning in the
year of the First Commercial Sale of Licensed Product. Licensee must pay the minimum annual royalty to The Regents by February
28 of each year. The minimum annual royalty will be credited against the earned royalty due and owing for the calendar year in
which the minimum payment was made.


 






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5.3
Paragraphs 1.1, 1.2, 1.3 and 1.4 define Regents' Patent Rights, Licensed Products, Licensed Methods and the Field of Use so
that royalties are payable on products covered by pending patent applications and issued patents. Royalties accrue for the duration
of this Agreement.


 


5.4
Licensee must pay royalties owed to The Regents on a quarterly basis. Licensee must pay the royalties within two months of
the end of the calendar quarter in which the royalties accrued.


 


5.5
All monies due The Regents must be paid in United States funds. When Licensed Products are sold for monies other than United
States dollars, the royalties will first be determined in the foreign currency of the country in which those Licensed Products
were sold and, second, converted into equivalent United States funds. Licensee must use the exchange rate established by the Bank
of America in San Francisco, California on the last day of the calendar quarter.


 


5.6
Any tax for the account of The Regents required to be withheld by Licensee under the laws of any foreign country must be promptly
paid by Licensee for and on behalf of The Regents to the appropriate governmental authority. Licensee will use its best efforts
to furnish The Regents with proof of payment of any tax. Licensee is responsible for all bank transfer charges. All payments made
by Licensee in fulfillment of The Regents' tax liability in any particular country will be credited against fees or royalties due
The Regents for that country.


 


5.7
If at any time legal restrictions prevent the acquisition or prompt remittance of United States Dollars by Licensee with respect
to any country where a Licensed Product is sold, the Licensee shall pay royalties due to The Regents from Licensee's other sources
of United States Dollars.


 


5.8
If any patent or any claim included in Regents' Patent Rights is held invalid or unenforceable in a final decision by a court
of competent jurisdiction from which no appeal has or can be taken, all obligation to pay royalties based on that patent or claim
or any claim patentably indistinct from it will cease as of the date of that final decision. Licensee will not, however, be relieved
from paying any royalties that accrued before that decision or that is based on another patent or claim not involved in that decision.


 


5.9
No royalties will be collected or paid on Licensed Products sold to the United States Federal Government, or any agency of
the United States Government. The Licensee and its Sublicensee will reduce the amount charged for Licensed Products distributed
to the United States Government by the amount of the royalty.


 


6. DILIGENCE 


 


6.1
Upon the execution of this Agreement, Licensee must diligently proceed with the development, manufacture and sale ("Commercialization")
of Licensed Products and must earnestly and diligently endeavor to market them within a reasonable time after execution of this
Agreement and in quantities sufficient to meet the market demands for them.


 


6.2
Licensee must endeavor to obtain all necessary governmental approvals for the Commercialization of Licensed Products.


 


6.3
The Regents has the right and option to either terminate this Agreement, narrow the fields of use granted under paragraph 1.4
or reduce Licensee's exclusive license to a nonexclusive license if Licensee fails to perform any of the terms in this Paragraph
6.3. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).


 






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6.3a Within
twenty-four months from the Effective Date of this Agreement, Licensee will file, cross-file or transfer an investigational new
drug application (IND) relating to the Licensed Product for each field of use selected under paragraph 1.4 of this Agreement.


 


6.3b Within
five years of the Effective Date of this Agreement, initiate Phase II clinical trials for a Licensed Product for each field of
use selected under paragraph 1.4 of this Agreement.


 


6.3c Within
eight years of the Effective Date of this Agreement, initiate Phase III clinical trials for a Licensed Products for each field
of use selected under paragraph 1.4 of this Agreement.


 


6.3d Within
fourteen years of the Effective Date of this Agreement complete a First Commercial Sale of a Licensed Product for each field of
use selected under paragraph 1.4 of this Agreement.


 


6.4
Licensee has the sole discretion for making all decisions as to how to commercialize any Licensed Product.


 


7. PATENT FILING, PROSECUTION
AND MAINTENANCE


 


7.1
As long as Licensee is paying prosecution costs, The Regents will file, prosecute and maintain the patents and applications
comprising Regents' Patent Rights. These patents will be held in the name of The Regents and will be obtained with counsel of The
Regents' choice. The Regents must provide Licensee with copies of each patent application, office action, response to office action,
request for terminal disclaimer, and request for reissue or reexamination of any patent or patent application under Regents' Patent
Rights. The Regents will consider any comments or suggestions by Licensee: The
Regents is entitled to take action to preserve rights and minimize costs whether or not Licensee has commented. 


 


7.2
Licensee will bear all costs incurred prior to and during the term of this Agreement in the preparation, filing, prosecution
and maintenance of patent applications and patents in Regents' Patent Rights. Prosecution includes interferences, oppositions and
any other inter parties matters originating in a patent office. Licensee must send payment to The Regents within 30 days of Licensee's
receipt of an invoice.


 


7.3
Licensee has the right to request patent protection on the Invention in foreign countries if the rights are available. Licensee
must notify The Regents of its decision within eight months of the filing of the corresponding United States patent application.
This notice must be in writing and must identify the countries desired. The absence of this notice from Licensee to The Regents
will be considered an election not to secure foreign rights.


 


7.4
Eight months after the filing of the corresponding United States application, but not sooner, The Regents will have the right
to file patent applications at its own expense in any country which Licensee has not identified in written notice provided by 7.3.
These applications and resulting patents will not be subject to this Agreement.


 


7.5
Licensee's obligation to underwrite and to pay all United States and foreign patent costs will continue for as long as this
Agreement remains in effect. Licensee may terminate its obligations with respect to any given patent application or patent upon
three months written notice to The Regents. The Regents will use its best efforts to curtail patent costs chargeable to Licensee
under this Agreement after this notice is received from Licensee. The Regents may continue prosecution or maintenance of these
application(s) or patent(s) at its sole discretion and expense, and Licensee will have no further rights or licenses to them.


 






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7.6
The Regents will use its best efforts to not allow any Regents' Patent Rights for which Licensee is licensed and is underwriting
the costs of to lapse or become abandoned without Licensee's authorization or reasonable notice, except for the filing of continuations,
divisionals, or the like which substitute for the lapsed application.


 


8. PATENT INFRINGEMENT



 


8.1
In the event that The Regents (to the extent of the actual knowledge of the licensing professional responsible for the administration
of this Agreement) or the Licensee learns of infringement of potential commercial significance of any patent licensed under this
Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence
of such infringement available to it (the "Infringement Notice"). During the period in which, and in the jurisdiction
where, the Licensee has exclusive rights under this Agreement, neither The Regents nor the Licensee will notify a third party (including
the infringer) of infringement or put such third party on notice of the existence of any Patent Rights without first obtaining
consent of the other. If the Licensee puts such infringer on notice of the existence of any Patent Rights with respect to such
infringement without first obtaining the written consent of The Regents and if a declaratory judgment action is filed by such infringer
against The Regents, then Licensee's right to initiate a suit against such infringer for infringement under Paragraph 8.2 below
will terminate immediately without the obligation of The Regents to provide notice to the Licensee. Both The Regents and the Licensee
will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.


 


8.2
If infringing activity of potential commercial significance by the infringer has not been abated within ninety (90) days following
the date the Infringement Notice takes effect, then the Licensee may institute suit for patent infringement against the infringer.
The Regents may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the
acts of infringement that are the subject of the Licensee's suit or any judgment rendered in the suit. The Licensee may not join
The Regents in a suit initiated by Licensee without The Regents' prior written consent. If, in a suit initiated by the Licensee,
The Regents is involuntarily joined other than by the Licensee, then the Licensee will pay any costs incurred by The Regents arising
out of such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to represent it
in the suit.


 


8.3
If, within a hundred and twenty (120) days following the date the Infringement Notice takes effect, infringing activity of
potential commercial significance by the infringer has not been abated and if the Licensee has not brought suit against the infringer,
then The Regents may institute such suit for patent infringement against the infringer. If The Regents institutes such suit, then
the Licensee may not join such suit without The Regents consent and may not thereafter commence suit against the infringer for
acts of infringement that are subject to The Regents suit or any judgment rendered in that suit. 


 


8.4
Any recovery or settlement received in connection with any suit will first be shared by The Regents and the Licensee equally
to cover any litigation costs each incurred and next shall be paid to The Regents or the Licensee to cover any litigation costs
it incurred in excess of the litigation costs of the other. In any suit initiated by the Licensee, any recovery in excess of litigation
costs will be shared between Licensee and The Regents as follows: (a) for any recovery other than amounts paid for willful infringement:
(i) The Regents will receive fifteen percent (15%) of the recovery if The Regents was not a party in the litigation and did not
incur any litigation costs, (ii) The Regents will receive twenty-five percent (25%) if The Regents was party in the litigation,
but did not incur any litigation costs, including provisions of Paragraph 8.2 above, and (iii) The Regents will receive fifty percent
(50%) of the recovery if The Regents incurred any litigation costs in connection with the litigation; and (b) for any recovery
for willful infringement, The Regents will receive fifty percent (50%) of the recovery. In any suit initiated by The Regents, any
recovery in excess of litigation costs will belong to The Regents. The Regents and the Licensee agree to be bound by all determinations
of patent infringement, validity and enforceability (but no other issue) resolved by any adjudicated judgment in a suit brought
in compliance with this Article 8 (Patent Infringement).


 






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8.5
Any agreement made by the Licensee for purposes of settling litigation or other dispute shall comply with the requirements
of Article 3 (Sublicenses) of this Agreement.


 


8.6
Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who
initiated the suit (unless such suit is being jointly prosecuted by the parties).


 


8.7
Any litigation proceedings will be controlled by the party bringing the suit, except that The Regents may be represented by
counsel of its choice in any suit brought by the Licensee.


 


9. PROGRESS AND ROYALTY
REPORTS


 


9.1
Beginning January 31, 2006, Licensee must submit to The Regents semiannual progress reports covering Licensee's activities
related to the development and testing of all Licensed Products and the obtaining of the governmental approvals necessary for marketing.
These progress reports must be made for each Licensed Product until its First Commercial Sale.


 


9.2
The progress reports submitted under Paragraph 9.1 must include the following topics:


 


9.2a Summary
of work completed.


 


9.2b Key scientific
discoveries.


 


9.2c Summary
of work in progress.


 


9.2d Current
schedule of anticipated events or milestones.


 


9.2e Market
plans for introduction of Licensed Products.


 


9.2f A summary
of resources ( dollar value) spent in the reporting period.


 


9.3.
Licensee must notify The Regents if Licensee or any of its Sublicensees or Affiliates ceases to be a small entity (as defined
by the United States Patent and Trademark Office) under the provisions of 35 U.S.C. §41(h).


 


9.4
Licensee must report the date of the First Commercial Sale in the royalty report immediately following that Sale.


 


 


9.5 After
the First Commercial Sale of each Licensed Product, Licensee must make quarterly royalty reports to The Regents by February 28,
May 31, August 31 and November 30 of each year (i.e., within two months from the end of each calendar quarter). Each royalty report
must cover Licensee's most recently completed calendar quarter and must show:


 






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9.5a Gross sales
and Net Sales of any Licensed Product.


 


9.5b Number of
each type of Licensed Product sold.


 


9.5c Royalties
payable to The Regents.


 


9.6 Licensee must state in its
royalty report if it had no sales of any Licensed Product.


 


10. BOOKS AND RECORDS



 


10.1 Licensee
must keep accurate books and records of all Licensed Products manufactured, used or sold. Licensee must preserve these books and
records for at least five years from the date of the royalty payment to which they pertain.


 


 


 


10.2 The
Regents' representatives or agents are entitled to inspect these books and records at reasonable times. The Regents will pay the
fees and expenses of these inspections. If an error · favoring
Licensee of more than 5% of the total annual royalties is discovered, then Licensee will pay the fees and expenses of these inspections.



 


11. LIFE OF THE AGREEMENT



 


11.1 Unless
otherwise terminated by operation of law or by acts of the parties in accordance with the terms of this Agreement, this Agreement
is in force from the Effective Date recited on page one and remains in effect for the life of the last-to-expire patent in Regents'
Patent Rights, or until the last patent application licensed under this Agreement is abandoned and no patent in Regents' Patent
Rights ever issues.


 


11.2 Upon
termination of this Agreement, Licensee will have no further right to make, have made, use or sell any Licensed Product except
as provided in Article 14 (Disposition of Licensed Products on Hand Upon Termination).


 


11.3 Any
expiration or termination of this Agreement will not affect the rights and obligations set forth in the following Articles:


 


Article 10


Article 14


Article 16


Article 17


Article 18


Article 23


Article 24


Books and Records


Disposition of Licensed
Products on Hand upon Termination.


Use of Names and Trademarks.


Warranties


Indemnification.


Failure to Perform.


Governing Law


 






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12. TERMINATION BY THE
REGENTS 


 


12.1
If Licensee violates or fails to perform any material term or covenant of this Agreement,
then The Regents may give written notice of the default ("Notice of Default") to
Licensee. If Licensee does not repair the default within 60 days after the effective date of the Notice of Default, then The Regents
has the right to terminate this Agreement and the License by a second written notice ("Notice of Termination") to Licensee.
If The Regents sends a Notice of Termination to Licensee, then this Agreement automatically terminates on the effective date of
this notice. Termination does not relieve Licensee of its obligation to pay any royalty or fees owing at the time of termination
and does not impair any accrued right of The Regents. 


 


13. TERMINATION BY LICENSEE


 


13.1
Licensee has the right at any time to terminate this Agreement in whole or with respect to any portion of Regents' Patent Rights
by giving written notice to The Regents. This notice of termination will be subject to Article 19 (Notices) and will be effective
90 days after the effective date of the notice.


  


13.2
Any termination in accordance with Paragraph 13.1 does not relieve Licensee of any obligation or liability accrued prior to
termination. Nor does termination rescind anything done
by Licensee or any payments made to The Regents prior to the effective date of termination. Termination does not affect in any
manner any rights of The Regents arising under this Agreement prior to termination. 


 


14.
DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION


 


14.1
Upon termination of this Agreement, Licensee will have the right to dispose of all previously made or partially made Licensed
Products, but no more, within a period of six months. But Licensee must submit royalty reports on the sale of these Licensed Products
and must pay royalties at the rate and at the time provided in this Agreement.


 


15. PATENTMARKING


 


15.1
Licensee must mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance
with the applicable patent marking laws.


 


16. USE OF NAMES AND TRADEMARKS


 


16.1
Neither party is permitted to use any name, trade name, trademark
or other designation of the other party or its employees (including contraction, abbreviation or simulation of any of the foregoing)
in advertising, publicity or other promotional activity.
Unless required by law, Licensee is expressly prohibited from using the name "The Regents of the University of California"
or the name of any campus of the University of California. 


 


17. LIMITED WARRANTY


 


17.1
The Regents warrants that it has the lawful right to grant this license to Licensee.


 


17.2
This License and the associated Invention are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. THE REGENTS MAKE NO REPRESENTATION OR WARRANTY THAT ANY LICENSED PRODUCT WILL NOT INFRINGE
ANY PATENT OR OTHER PROPRIETARY RIGHT.


 






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17.3
IN NO EVENT WILL THE REGENTS BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS
LICENSE OR THE USE OF THE INVENTION OR LICENSED PRODUCTS OR THE USE OR THE PRACTICE OF LICENSED METHODS.


 


17.4
Nothing in this Agreement will be construed as:


 


17.4a A
warranty or representation by The Regents as to the validity or scope of any Regents' Patent Rights.


 


17.4b A
warranty or representation that anything made, used, sold or otherwise disposed of under any license granted in this Agreement
is or will be free from infringement of patents of third parties.


 


17.4c Obligate
The Regents to bring or prosecute actions or suits against third parties for patent infringement except as provided in Article
8 (Patent Infringement).


 


17.4d Conferring
by implication, estoppel or otherwise any license or rights under any patents of The Regents other than Regents' Patent Rights
as defined herein, regardless of whether such patents are dominant or subordinate to Regents' Patent Rights.


 


17.4e Obligate
The Regents to furnish any know-how not provided in Regents' Patent Rights.


 


18. INDEMNIFICATION 


 


18.1
Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend The Regents, its officers, employees,
and agents, the sponsors of the research that led to the invention, the inventors of the patents and patent applications in Regents'
Patent Rights and their respective employers from and against any and all liability, claims, suits, losses, damages, costs, fees
and expenses resulting from or arising out of exercise of this license or any sublicense. Indemnification indudes but is not limited
to products liability. If The Regents, in its sole discretion, believes that there will be a conflict of interest or it will not
otherwise be adequately represented by counsel chosen by Licensee to defend The Regents in accordance with this Paragraph 18.1,
then The Regents may retain counsel of its choice to represent it, and Licensee will pay all expenses for such representation.


 


18.2
For the first use of the Licensed Product for humans and thereafter, Licensee, at its sole cost and expense, must insure its
activities in connection with the work under this Agreement and obtain, keep in force and maintain Comprehensive or Commercial
Form General Liability Insurance (contractual liability included) with limits as follows:


 


18.2a
Each occurrence $5,000,000


18.2b
Products/completed operations aggregate $10,000,000


18.2c Personal
and advertising injury $5,000,000


18.2d General aggregate
(commercial form only) $10,000,000


 






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18.3
Licensee expressly understands, however, that the coverages and limits in Paragraph 18.2 do not in any way limit the Licensee's
liability. Licensee must furnish The Regents with certificates of insurance evidencing compliance with all requirements. Licensee's
insurance must:


 


18.3a Provide for 30-day advance
written notice to The Regents of any modification.


18.3b Indicate that The Regents
of the University of California is endorsed as an Insured under the coverages listed in Paragraph 18.2.


18.3c Include a
provision that the coverages will be primary and will not participate with nor will be excess over any valid and collective insurance
or program of self-insurance carried or maintained by The Regents. 


 


18.4 The Regents shall
notify Licensee in writing of any claim or suit brought against The Regents in respect of which The Regents intends to invoke the
provisions of this Article 18 (Indemnification). Licensee shall keep The Regents informed on a current basis of its defense of
any claims under this Article 18 (Indemnification).





 






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19. NOTICES 


 


19.1 Any notice or payment
required to be given to either party must be sent to the respective address given below and is effective: (a) on the date of delivery
if delivered in person, (b) five days after mailing if mailed by first-class certified mail, postage paid, or ( c) on the next
business day if sent by overnight delivery. Either party may change its designated address by written notice.


 





	 	For Licensee: 	GENERAL FIBER, INC. 
	 	 	801 Brickell Avenue 9th  Floor Suite 942 
	 	 	Miami, Florida 
	 	 	Attention: Nicholas Stergis 
	 	 	 
	 	For The Regents: 	The Regents of the University of California University of California, Los Angeles Office of Intellectual Property Administration 10920 Wilshire Blvd., Suite 1200 Los Angeles, California 90095-1406 
	 	 	Attention: Director 


 


20. ASSIGNABILITY 


 


20.1 This Agreement
is binding upon and inures to the benefit of The Regents, its successors and assigns. But it is personal to Licensee and assignable
by Licensee only with the written consent of The Regents. The consent of The Regents will not be required if the assignment is
in conjunction with the transfer of all or substantially all of the business of Licensee to which this license relates.


 


21. LATE PAYMENTS 


 


21.1
For each royalty payment or fee not received by The Regents when due, Licensee must pay to The Regents a simple interest charge
of 10% per annum to be calculated from the date payment was due until it was actually received by The Regents.


 


22. WAIVER 


 


22.1 The waiver
of any breach of any term of this Agreement does not waive any other breach of that or any other term.


 


23. FAILURE TO PERFORM



 


23.1
If either party takes legal action against the other because of a failure of performance due under this Agreement, then the
prevailing party is entitled to reasonable attorney's fees in addition to costs and necessary disbursements.


 


24. GOVERNING LAW 


 


24.1
THIS AGREEMENT IS TO BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, but the scope and
validity of any patent or patent application will be governed by the applicable laws of the country of the patent or patent application.


 






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25. GOVERNMENT APPROVAL
OR REGISTRATION


 


25.1
If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with
any governmental agency, Licensee will assume all legal obligations to do so. Licensee will notify The Regents if it becomes aware
that this Agreement is subject to a United States or foreign government reporting or approval requirement. Licensee will make all
necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting
or approval process.


 


26. EXPORT CONTROL LAWS


 


26.1
Licensee must observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related
technical data to foreign countries, including the International Traffic in Arms Regulations (IT AR) and the Export Administration
Regulations.


 


27. PREFERENCE FOR UNITED
STATES INDUSTRY


 


27.1
Because this Agreement grants an exclusive right to a particular use of the Invention, Licensee must manufacture in the United
States any products embodying this Invention or produced through the Invention's use to the extent required by 35 U.S.C. §200-212.


 


28. FORCE MAJEURE


 


28.1
The parties will be excused from any performance required under this Agreement if performance is impossible or unfeasible due
to any catastrophe or other major event beyond their reasonable control, including war, riot, or insurrection; lockouts or other
serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events abate, and in any event within
one year, the parties' respective obligations will resume.


 


29. CONFIDENTIALITY 


 


29.1
If either party discloses confidential information to the other party, the disclosing party will designate this information
as confidential by appropriate legend or instruction, and the receiving party will:


 


29.1a Use
the same degree of care to maintain the secrecy of the confidential information as it uses to maintain the secrecy of its own information
of like kind.


 


29.1 b Use
the confidential information only to accomplish the purposes of this Agreement.


 


29.2
Neither party will disclose confidential information received from the other party except to its employees, customers, distributors
and other agents who are bound to it by similar obligations of confidence and only as required to accomplish the purposes of this
Agreement.


 


29.3
Neither party will have any confidentiality obligation with respect to the confidential information belonging to or disclosed
by the other party that:


 


29.3a The
receiving party can demonstrate by written records was previously known to it.


 


29.3b The
receiving party lawfully obtained from sources under no obligation of confidentiality.


 






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29.3c Is
or becomes publicly available other than through an act or omission of the receiving party or any of its employees.


 


29.3d Is
required to be disclosed under the California Public Records Act, governmental audit requirement or other requirement of law.


 


29.4
The provisions of this Article 29 will continue III effect for five years after expiration or termination of this Agreement.


 


29.5
The Regents is free to release to the inventors and senior administrators employed by The Regents the terms and conditions
of this Agreement. If such release is made, then The Regents shall give notice of the confidential nature and shall request that
the recipient not disclose such terms and conditions to others. If a third party inquires whether a license to Regents' Patent
Rights is available, then The Regents may disclose the existence of this Agreement and the extent of the grant in Article 2 (Grant)
to such third party, but will not disclose the name of Licensee or any other terms or conditions of this Agreement, except where
The Regents is required to release information under the California Public Records Act, a governmental audit requirement, or other
applicable law.


 


30. MISCELLANEOUS 


 


30.1
The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of, or
to affect the meaning or interpretation of, this Agreement.


 


30.2
This Agreement is not binding upon the parties until it has been signed below on behalf of each party, in which event it becomes
effective as of the date recited on page one.


 


30.3
No amendment or modification of this Agreement will be valid or binding upon the parties unless made in writing and signed
by each party.


 


30.4
This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations
or understandings, either oral or written, between the
parties relating to the subject matter hereof, except for the Secrecy Agreement dated 10-20-03, which continues to the extent
it is not inconsistent with this Agreement. 


 


30.5
If any part of this Agreement is for any reason found to be unenforceable, all
other parts nevertheless remain enforceable as long as a party's rights under this Agreement are not materially affected.
In lieu of the unenforceable provision, the parties will substitute or add as part of this
Agreement a provision that will be as similar as possible in economic and business objectives as was intended by the unenforceable
provision. 


 


Both
The Regents and Licensee have executed this Agreement in duplicate originals by their authorized officers on the dates written
below:


 





	GENERAL FIBER, INC 	THE REGENTS OF THE UNIVERSITY OF CALIFORNIA 
	 	 
	By: /s/ Nicholas Stergis	By: /s/ Emily Loughran
	Name: Nicholas Stergis	Name: Emily Loughran
	Title: Chief Operating Officer	Title: Director of Licensing
	 	 
	Dated: July 11, 2005	Dated: July 5, 2005


 






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APPENDIX A


 


REGENTS’ PATENT RIGHTS


 


U.S. Patent Application No. 10/131,384 entitled
“Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases,” filed April 24, 2002, which was based on Provisional
ApplicationNo. 60/286,842 filed 4/25/01 (UCLA Case Nos 1998-531-1,2) by Dr. Voskuhl, and assigned to The Regents.


 


U.S. Patent Application No. 10/984,364 entitled “The Use
of Estrial and Other Estranes, Estrogen and Estrogen Receptor Active Compositions in the Treatment of Psoriasis...,”
filed November 8, 2004, (UCLA Case No. 2004-101-3) by Drs. Rhonda R. Voskuhl, Gerald D. Weinstein and Jenny E. Murase and assigned
to The Regents.


 


European Patent Application No. 02729034.5 based on PCT/US02/13407,
filed April 25, 2002 entitled “Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases” by Dr. Rhonda
R. Voskuhl.


 






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EXCLUSIVE LICENSE AGREEMENT


 


TABLE OF CONTENTS


 





	 	ARTICLE PAGE NUMBER 
	RECITALS	1 
	 	 
	1. DEFINITIONS 	1 
	 	 
	2. GRANT 	3 
	 	 
	3. SUBLICENSES	3 
	 	 
	4. FEES 	4 
	 	 
	5. ROYALTIES 	4 
	 	 
	6. DILIGENCE 	5 
	 	 
	7. PATENT FILING, PROSECUTION AND MAINTENANCE 	6 
	 	 
	8. PATENT INFRINGEMENT 	7 
	 	 
	9. PROGRESS AND ROYALTY REPORTS 	8 
	 	 
	10. BOOKS AND RECORDS 	9 
	 	 
	11. LIFE OF THE AGREEMENT	9 
	 	 
	12. TERMINATION BY THE REGENTS	10 
	 	 
	13. TERMINATION BY LICENSEE	10 
	 	 
	14. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION 	10 
	 	 
	15. PATENT MARKING 	10 
	 	 
	16. USE OF NAMES AND TRADEMARKS	10 
	 	 
	17. LIMITED WARRANTY 	10 
	 	 
	18. INDEMNIFICATION	11 
	 	 
	19. NOTICES	12 
	 	 
	20. ASSIGNABILITY 	12 
	 	 
	21. LATE PAYMENTS 	13 
	 	 
	22. WAIVER 	13 
	 	 
	23. FAILURE TO PERFORM 	13 
	 	 
	24. GOVERNING LAWS 	13 
	 	 
	25. GOVERNMENT APPROVAL OR REGISTRATION 	13 
	 	 
	26. EXPORT CONTROL LAWS 	13 
	 	 
	27. PREFERENCE FOR UNITED STATES INDUSTRY 	13 
	 	 
	28. FORCE MAJEURE 	13 
	 	 
	29. CONFIDENTIALITY 	14 
	 	 
	30. MISCELLANEOUS 	14 
	 	 
	APPENDIX A 	 







 






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