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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