Exhibit 10.8
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made as of the 25th day of
August 1994, by and between EDENLAND INC., a corporation duly organized and
existing under the laws of Delaware (hereinafter "Edenland") (Edenland is
sometimes referred to herein as the "Licensor"), XXXXXXX X. XXXXXXXXXXX,
Baybush, Straffan, Ireland (hereinafter "Owner"), HOLMEDCO PHARMACEUTICALS
CORPORATION, 0000 XX 000xx Xxxxxx, Xxxxxxxxx XX 00000, U.S.A., a
corporation duly organized and existing under the laws of Delaware
("Holmedco" and/or "Licensee") and, only for purposes of Section 3.11,
XXXXXXX X. XXXXXX ("Xxxxxx") (each a "Party" and collectively the
"Parties"). Capitalized terms shall have the meanings given them in
Section 1 of this Agreement.
R E C I T A L S
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A. Owner has developed a non-HIV based Anti-Serum which is capable
of binding the HIV virus and removing it from the bloodstream.
B. Owner has assigned via Licensor's Affiliate companies, to
Licensor all of his rights to the Patent Rights, Know-How and Background
Information from which the Anti-Serum is based to facilitate Licensor's
undertakings and representations as per the terms of this Agreement.
C. Holmedco desires to acquire an exclusive worldwide license from
Licensor to allow Holmedco to use the Patent Rights, Know-How and
Background Information and to practice the Licensed Processes on the terms
and conditions set forth below.
D. Owner, Licensor and Licensee are also parties to the Development
Agreement pursuant to which (i) Licensor will further develop the
Anti-Serum to a stage of development that demonstrates the toxicity and
safety profile and also indicates potential efficacy in Phase II (FDA)
patient studies, and (ii) Licensor has granted Holmedco the right of first
option on New Products conceived or developed by Licensor, which are funded
according to the conditions of the said Development Agreement, to make such
New Products and the Patent Rights, Know-How and Background Technology
relating to such New Products subject to this Agreement.
NOW, THEREFORE, the Parties hereby agree as follows:
1. DEFINITIONS
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1.1 "ABSTRACT" shall mean that certain official abstract prepared for
the 9th Mediterranean Congress of Chemotherapy entitled "Clinical Trial for
the Safety and Effectiveness of HIV Reactive, Immunoaffinity Purified
Anti-Human Alpha Fetoprotein in Patients with HIV Infections," as attached
in Appendix B to the Development Agreement.
1.2 "AFFILIATE" means (a) any company owned or controlled to the
extent of at least fifty percent (50%) of its issued and voting capital
stock by a Party to this Agreement and any other company so owned or
controlled (directly or indirectly) by any such company or the owner of any
such company, or (b) any partnership, joint venture or other entity
directly or indirectly controlled by, controlling, or under common control
of, to the extent fifty percent (50%) or more of voting power (or otherwise
having power to control its general activities), a Party to this Agreement,
but in each case only for so long as such ownership or control shall
continue.
1.3 "ANTI-SERUM" means the anti-serum derived from the Existing
Patent Rights, Know-How and Background Technology which is referenced in
the Abstract and any other product for human and/or animal therapeutic or
prophylactic use, now or hereafter developed by Licensor, which is derived
(or capable of being derived) from or incorporates any of the Existing
Patent Rights, Know-How or Background Technology upon which the anti-serum
is based.
1.4 "BACKGROUND TECHNOLOGY" shall mean all Elements of Technology (as
defined below) that are necessary or useful to commercialize and exploit
the Products and that Edenland or Owner (or any of their respective
Affiliates) has an ownership interest in or has the right to acquire an
ownership interest, controls in or may conceive, develop or acquire an
ownership interest in (under licenses from others or otherwise) at any time
prior to or during the term of this Agreement.
1.5 "COMBINATION PRODUCT" shall mean any product that is formulated
in part of any Product (or any part thereof) and in part of any Combination
Substances.
1.6 "COMBINATION PRODUCT NET SALES" shall have the meaning given that
term in the definition for "Product Revenues."
1.7 "COMBINATION SUBSTANCES" shall mean the product or substance,
other than a Product, that is sold in combination with a Product.
1.8 "DAMAGES" shall have the meaning given to it in Section 10.1.
1.9 "DEVELOPMENT AGREEMENT" shall mean the Research, Development and
Option Agreement between the parties of even date herewith.
1.10 "ELEMENTS OF TECHNOLOGY" shall mean all technical information,
whether tangible or intangible, that relates to any Product or is from
which the Product is based, including any and all data, preclinical and
clinical results, techniques, discoveries, inventions, ideas, processes,
know-how, patents (including any extension, reissue or renewal patents),
patent applications, inventor's certificates, trade secrets and other
proprietary information, licenses and sublicenses and samples of any
physical, biological or chemical material.
1.11 "EXISTING PATENT RIGHTS" shall mean the United States and foreign
patents and/or patent applications listed in Exhibit A.
1.12 "FDA" means the United States Food and Drug Administration, or
any state governmental agency in the United States that may also have
jurisdiction over the drug approval process in conjunction with the United
States Food and Drug Administration or any governmental agency performing
similar functions in any country within the Territory; provided, if the
governmental agency is outside the United States, it shall only be
considered an "FDA" for purposes of this definition if the approval by such
agency will allow Licensee to exploit and commercialize a sizeable and
profitable market segment.
1.13 "FIELD OF ACTIVITY" shall mean the use (including any use in
connection with research, development, demonstration, testing or
experimentation) of the Products for, or the manufacture, sale or other
disposition of the Products for, human or animal therapeutic or
prophylactic use within the Territory, including without limitation, any
use for arrest and therapy of, or for vaccination against, retroviruses and
bacterial infections.
1.14 "FORCE MAJEURE EVENT" shall have the meaning given it in Section
12.
1.15 "FUTURE PATENT RIGHTS" shall mean any U.S. or foreign patent
rights arising from the Know-How, Background Technology, Intellectual
Property or the Improvements.
1.16 "IMPROVEMENTS" shall mean any findings, discoveries, inventions,
additions, modifications, formulations or changes made by licensees during
the term of this Agreement which directly relate to the Products or
Licensed Processes including, without limitation, new or improved methods
of administration, improved side effect profile, new medical indications
and improvements in the manufacturing process.
1.17 "INFRINGEMENT PROCEEDS" shall have the meaning given that term in
Section 7.4.
1.18 "INTELLECTUAL PROPERTY" means any invention, modification,
discovery, design, development, improvement, process, software program,
work of authorship, documentation, formula, data, technique, know-how,,
secret or other intellectual property whatsoever or any interest therein
(whether or not patentable or registrable under copyright or similar
statutes or subject to analogous protection) that relates to any Product
being developed by Licensor under the Development Agreement, BUT EXCLUDING
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any (i) trademarks or (ii) the manuscript currently being completed on the
life of the Owner or any film, documentary or copyright relating to such
manuscript or any future additions of a similar manuscript.
1.19 "KNOW-HOW" shall mean any and all technical information presently
available or generated during the term of this Agreement which directly
relates to the Products, Licensed Processes or Improvements and shall
include, without limitation, (i) the medical, clinical, chemical,
pharmaceutical, pharmacological, topological, toxicological or other
scientific data or information relating to any Product (including without
limitation, pre-clinical and clinical data, notes, reports, models and
samples) and (ii) the manufacturing, production, and purification
procedures and processes, as well as analytical methodology, used in
testing, assaying, analysis, production, and packaging of any Product.
1.20 "LICENSED PROCESSES" shall mean the processes which are used in
any country in the Territory, and which;
(a) is covered in whole or in part by any of the
Patent Rights or Know-How;
(b) is derived from the Patent Rights or Know-How; or
(c) is covered in whole or in part by the Background
Technology.
1.21 "NET SALES" with respect to sales for any period and with respect
to any item, shall mean the actual proceeds received by Holmedco, its
Affiliates and/or sublicensees, from third parties, whose dealings shall be
at arms length, for Products and Combination Products sold under this
Agreement, net of trade, quantity and cash discounts, if any, actually
allowed or paid with respect to Products or Combination Products; and less
each and all of the following allowed or paid by Holmedco, its Affiliates
and sublicensees; trade credits, rebates and allowances actually granted on
account of price adjustments, rebate programs, billing errors or the
rejection or return of goods; commissions actually allowed or paid to
independent brokers or agents; export packaging, outbound freight or
transportation charges; and all taxes (except income taxes), tariffs,
duties and other similar governmental charges paid by Holmedco or its
Affiliates or sublicensees, all determined in accordance with the generally
accepted accounting principles applicable in the United States,
consistently applied. In calculating Net Sales, any given unit of a
Product or Combination Product shall be taken into account only once.
1.22 "NEW PRODUCT" means any new pharmaceutical or medical product or
process conceived or developed by Licensor, Owner or any of their
Affiliates, or any person acting under the direction of Licensor, Owner or
any of their Affiliates, whether conceived or developed prior to or during
the term of the Development Agreement. Owner has already entered into an
Exclusive License Agreement concerning his patent rights and know-how for
the use, development and exploitation of DHEA, its improvements and
combination in the treatment of humans and animals and all Parties to this
Agreement are fully aware of this previous license. Funder hereby
acknowledges that the rights so granted are not and shall not become, under
any conditions, a part of this Agreement.
1.23 "NDA" shall mean any pending or approved application or any
application to be filed with respect to the Products, including any
Improvements thereof, submitted or to be submitted to the FDA under the
applicable food and drug law in each and any country of the Territory.
1.24 "PATENT RIGHTS" shall mean all of each of the Licensor's and
Owner's rights in the following intellectual property:
(a) the Existing Patent Rights and Future Patent
Rights;
(b) United States and foreign patents issued from the
Existing Patent Rights or Future Patent Rights and from divisions and
continuations thereof;
(c) claims of U.S. and foreign patents issued from the
Existing Patent Rights and Future Patent Rights;
(d) claims of all foreign patent applications, and of
the resulting patents, which are counterparts to the claims in the U.S. and
foreign patents described in (a), (b) or (c) above; and
(e) any reissues or re-examinations of United States
patents or other patents within the Territory described in (a), (b), (c) or
(d) above.
1.25 "PRODUCT" shall mean treatment process, pharmaceutical
preparation, compound or biologic agent and any process or product or part
thereof which:
(a) is covered in whole or in part by an issued,
unexpired claim or a pending claim contained in the Patent Rights in any
country within the Territory; or
(b) is manufactured by using a process which is
covered in whole or in part by any of the Patent Rights and/or Know-How in
any country within the Territory in which such Licensed Process or part
thereof is used or the country in which Products made through the use of
such Licensed Process are used or sold; or
(c) is derived from the Patent Rights, Know-How or
Background Technology or related thereto.
1.26 "PRODUCT APPROVAL" means final FDA approval to market
commercially the specified product for use by humans or animals.
1.27 "PRODUCT REVENUES" for any period shall mean the sum of (i) the
aggregate amount of Net Sales (excluding Combination Product Net Sales) in
such period in the Field of Activity in respect of any Product and (ii) an
amount equal to: (A) the aggregate amount of Net Sales in such period in
the Field of Activity in respect of any Combination Product (the
"Combination Product Net Sales") multiplied by (B) a fraction the numerator
of which equals the fair market value of the Product (or any part thereof)
included in such Combination Product and the denominator of which equals
the sum of (x) the fair market value of such Product (or part thereof) and
(y) the fair market value of such Combination Substance included in such
Combination Product. For purposes of this definition, "fair market value"
of any Product or product (or part thereof) shall be the list retail price
of such Product or product (or part thereof sold separately or, if such
Product or product (or part thereof) is not ordinarily sold separately, a
value determined in the good faith business judgment of the Licensor and
Holmedco. Product Revenues realized by Holmedco, its Affiliates or
sublicensees within the Territory as a result of sales or trading utilizing
the facilities available pursuant to the Young Initiative (FDA duly 1988)
for sales of Products treating terminally ill patients, prior to United
States Product Approval, shall be utilized in calculating royalties due.
1.28 "RULES" shall have the meaning given that term in Section l 1.
1.29 "TERRITORY" shall mean the world.
1.30 "US. PATENT APPLICATIONS" shall have the meaning given that term
in Section 4.3.
1.31 "UNIVERSITY" means Louisiana State University.
2. LICENSE GRANT
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2.1 LICENSE GRANT. Edenland and Owner hereby jointly grant to
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Holmedco the exclusive world rights (even as to Edenland and Owner) to all
present and future Patent Rights, Know-How and the Background Technology
for all uses thereunder with the right to sublicense, to make, have made,
use and sell the Products and Combination Products, and to practice, modify
and improve the Licensed Processes within the Field of Activity, in the
Territory, all as herein provided.
2.2 LICENSE FEES. In consideration of the license granted in Section
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2.1 above, Holmedco shall pay the following licensing fees:
(a) Payment to Licensor of $25,000 upon signing this Agreement;
(b) Monthly payments to Licensor of $20,000 beginning on October
I, 1994 and ending on February l, 1995 unless Holmedco sooner pays in full
the license fee under subsection (c) of this Section 2.2;
(c) Payment to Licensor of $1,250,000 or such lesser amount as
provided in Section 3.1.
2.3 PROGRESS REPORTS ON FUNDING. During the first six months of this
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Agreement, Holmedco shall furnish to Edenland a written report on its
progress towards the securing of the funding on a monthly basis. If during
this period Owner or Licensor employees, executives or consultants are
required to attend presentations or discussions by Holmedco all reasonable
out-of-pocket expenses will be paid by Holmedco, such expenses to be agreed
in advance.
2.4 AGREEMENTS WITH THIRD PARTIES. During the term of this Agreement
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Holmedco shall not enter into any agreement concerning the rights of Owner
without the prior written approval of Owner provided however nothing herein
shall prohibit Holmedco from entering into agreements concerning its own
rights hereunder without Owner's consent, after payment of the license fees
specified in Section 2.2(c) above, including the sublicensing of its rights
under this Agreement.
3. LICENSE TERMS
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The terms of the License Agreement, are as set out hereunder:
3.1 $1,250,000 LICENSE FEE. Licensing fee of U.S. One Million Two
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Hundred Fifty Thousand Dollars ($1,250,000.00) to be paid not later than
28th, February, 1995; provided, however, such amount shall be reduced by
all payments made by Holmedco pursuant to subsections (a) and (b) of
Section 2.2 above. Contemporaneously with payment in full of such license
fee, Edenland and Owner shall grant Holmedco a first perfected security
interest in the Patent Rights and Know-How to secure Holmedco's exclusive
license hereunder and the obligations of Edenland and Owner hereunder and
shall execute such documents as are reasonably necessary and desirable to
create and perfect such security interests.
3.2 ROYALTIES. Holmedco shall pay to Edenland royalties of four (4%)
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percent which shall be calculated on the basis of Product Revenues
generated through the use, lease or sale of the Products or Combination
Products by or for Licensee or its sublicensees. Royalties shall not be
payable on Product released by Licensee for clinical trials. Licensee may
deduct from this royalty payment for Product Revenues received from any
country an amount equal to any payments made to Licensor for that country
under Section 3.3 below. In no event shall Licensee's payment of
Development Costs to Licensor under the Development Agreement constitute
the payment of royalties under this Section 3.2 or Section 3.3 below.
3.3 ROYALTIES ON SUBLICENSES. In the event of the sale of
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sublicenses or any other third-party agreements twenty-five (25 %) percent
of any fees so generated, either by monetary or other means, shall be
payable to Edenland upon execution of such sale.
3.4 LIMITATION ON ROYALTIES DUE.
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(a) From and after the fifth (5th) anniversary of the Product
Approval for a particular Product and through the tenth (10th) anniversary
thereof, the four percent (4%) royalty due under Section 3.2 shall be
reduced to two percent (2%) for Product Revenues generated in each country
where neither the Product nor the Licensed Process was ever covered in
whole or in part by any issued or pending claim contained in the Patent
Rights in such country; provided, however, upon the written request of
Holmedco, Licensor and Holmedco shall consider in good faith further
reducing such royalties based upon the then current competition in such
country generated by competing pharmaceutical products and its effect on
Holmedco's profitability.
(b) No royalties shall be payable under Section 3.2 or 3.3 on
Product Revenues generated from a Product sold after the tenth (10th)
anniversary of the Product Approval for such Product, in each country where
neither the Product nor the Licensed Process was ever covered in whole or
in part by any issued or pending claim contained in the Patent Rights.
(c) No royalties shall be payable under Section 3.2 or 3.3 on
Product Revenues generated from a Product sold in each country where the
Product and the Licensed Process from which such Product is made cease to
be covered in whole or in part by any issued or pending claim contained in
the Patent Rights in each such country.
3.5 CONTINGENT MINIMUM ROYALTY. Beginning on the second anniversary
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of the Product Approval for any Product with projected annual revenues to
Holmedco in excess of $25,000,000 (as determined in good faith by Holmedco
and Edenland on an annual basis before the annual license fee is due
hereunder), as a condition to retain the rights to commercially exploit the
Product under this Agreement, Holmedco shall pay Licensor, within thirty
(30) days following the anniversary date, an annual renewable (minimum
guaranteed royalty) license fee of $500,000 for such Product for a period
of six (6) years. The license fee shall be deducted from any royalty
payments due Licensor under Sections 3.2 and 3.3 during the term of this
Agreement. If Holmedco does not make the annual renewable license fee for
any given year, Edenland's exclusive remedy shall be (i) to terminate
Holmedco's right to make, use and sell such Product under this Agreement
and (ii) to license such rights to a third party at Edenland's discretion,
provided Licensor reimburses to Licensee all Development Costs paid by
Licensee to Licensor in accordance with the terms of Section 5.5 of the
Development Agreement.
3.6 ROYALTY REPORTS AND PAYMENTS. Within a period of sixty (60) days
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from the end of each quarter commencing from the first quarter after
Product is sold, Holmedco shall submit to Edenland a detailed report
detailing the amount of all royalties owing to Edenland during the quarter
to which the report refers, including full details of the sales made by
Holmedco and its sublicensees, and the considerations received by Holmedco
for the granting of sublicenses under Section 3.3 above, including, but
without derogating from the generality of the foregoing, sales according to
countries, itemization of the Product Revenues, the currency of sale, the
date of invoice, and any other detail relevant to enable the determination
of the royalties payable hereunder. Holmedco shall pay at the time of each
of the said reports the amount of the royalties owing to Edenland pursuant
to the said report for the period of the report, reduced by the amount of
any U.S. (at the federal and state level) and any other country's income
tax withholding which Holmedco may be required to pay under U.S. or such
other country's tax laws in respect of such royalties. Holmedco shall
discuss the most appropriate methods of payment with Edenland prior to
transmission of funds from countries within the Territory that may result
in the deduction of withholding taxes.
3.7 EDENLAND'S RIGHT TO INSPECT RECORDS. Edenland or its authorized
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representatives shall have the right from time to time (but not more than
twice each calendar year) during normal business hours to inspect
Holmedco's books of accounts, records and other relevant documentation
insofar as they relate to the manufacture or marketing of the Products, in
order to ascertain or verify the amount of royalties due to Edenland
hereunder and the accuracy of the information provided to Edenland in the
aforementioned reports. Holmedco's agreement with any licensees shall
grant Holmedco similar inspection rights and Holmedco shall share any
information received in exercising such rights with Edenland.
3.8 ROYALTIES IN COUNTRIES PROHIBITING TRANSFER OF CURRENCY ABROAD.
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Where royalties are due Edenland hereunder for sales of Products in a
country where, by reason of currency regulations or taxes of any kind, it
is impossible or illegal for Holmedco, any Affiliate or sublicensee to
transfer royalty payments to Edenland for Product Revenues in that country,
such royalties shall be deposited in whatever currency is allowable by the
person or entity not able to make the transfer for the benefit or credit of
Edenland in an accredited bank in that country that is acceptable to
Edenland.
3.9 STOCK OWNERSHIP. Holmedco shall issue to Edenland fifteen
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percent (15%) of the currently outstanding shares of Holmedco's common
stock. Ten percent (10%) of such equity shall be freely assignable amongst
Edenland's Affiliates. Further, Holmedco shall issue one percent (l %) of
the currently outstanding shares of Holmedco's Common Stock to Owner
without restriction on transfer other than compliance with applicable
securities laws.
3.10 STOCK OPTION. Holmedco shall grant Edenland the option to
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receive payment of its royalties under the license agreement in the form of
Holmedco's common stock. This option shall be limited to a maximum of five
percent (5%) of Holmedco's currently outstanding shares. The option is
subject to the Anti-Serum and/or vaccine developed therefrom receiving
Product Approval and generating cumulative Product Revenues to Holmedco of
$200,000,000. The option exercise price per share shall be the fair market
value on the date such revenue milestone is achieved and the option shall
have a term of five (5) years beginning from such date.
3.11 BOARD SEAT. Holmedco shall appoint either Xxx Xxxxxxxxxxx or
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Xxxxxxx Xxxxxxxxxxx, at Edenland's election, to serve on Holmedco's Board
of Directors for at least a one (1) year term. Thereafter, for a period of
two (2) years, Holmedco agrees to nominate, and Xxxxxx agrees to vote for,
Xxx Xxxxxxxxxxx or Xxxxxxx Xxxxxxxxxxx, at Edenland's election, to serve on
Holmedco's Board of Directors.
4. CERTAIN REPRESENTATIONS, WARRANTIES AND COVENANTS OF OWNER AND
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LICENSOR.
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4.1 EXISTING PATENT RIGHTS, KNOW-HOW AND BACKGROUND INFORMATION.
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Edenland and Owner represent and warrant that (i) they and their Affiliates
are the only persons who hold any interest in the Existing Patent Rights,
Know-How and Background Technology from which the Anti-Serum has been
derived, (ii) that such information is not based upon any non-public
information obtained from any other person, (iii) that they are the true
and first inventors of the invention described in the Existing Patent
Rights, (iv) that, as of the date of this Agreement, there are no lawful
grounds of objection to the grant of patents or the Existing Patent Rights,
(v) that they have not done or omitted any act to obtain the Existing
Patent Rights which would impair the validity of the Existing Patent
Rights, (vi) that there are no encumbrances or liens thereon, (vii) that
execution of this License Agreement and the Development Agreement is duly
authorized and does not breach any agreement with any third person or
entity, or any applicable law or regulation, (viii) the Existing Patent
Rights cover all of the patents, patent applications and patent rights (for
PP29, AFP and the vaccine) referenced in the "Patent Overview" dated August
17, 1994 provided by Licensor to Licensee, and (ix) that the Existing
Patent Rights are for all uses of their invention for the arrest and
therapy of human/animal retroviral infections.
4.2 THE ANTI-SERUM. Owner and Licenser further represent and warrant
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that: (i) the Anti-Serum referred to in the Abstract is exclusively subject
to, and has been manufactured under, the Existing Patent Rights; (ii) the
claims relating to the Existing Patent Rights cover in all respects the
rights to manufacture (produce), market and sell the Anti-Serum for the
arrest and therapy of human/animal retroviral therapy and that no other
party could manufacture (produce), market or sell the Anti-Serum for
indications covered in the Patent Rights including, without limitation, HIV
reactive alpha fetoprotein or cross reactive alpha fetoprotein for other
retroviruses, or a significantly similar pharmaceutical agent for the same
indications in the countries of the Territory covered by the Existing
Patent Rights during the term of this Agreement without first seeking a
license from Holmedco to do so; (iii) the Existing Patent Rights, Know-How
and Background Information will allow the Licensee to make (produce), use
and sell the Anti-Serum and no other party, including without limitation,
the University, owns any interest in any Intellectual Property used to
create the Anti-Serum, and (iv) they have no knowledge as of the date of
this Agreement of any material information, not heretofore disclosed to
Holmedco, relating to the safety or efficacy of the Anti-Serum.
4.3 PATENT COUNSEL OPINION. Within sixty (60) days of the signing of
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this Agreement, Licensor shall deliver to Holmedco an opinion of Licensor's
U.S. patent counsel, addressed to Holmedco, that (i) there are no lawful
grounds of objection to the grant of the patent applications listed in
Exhibit A; (ii) that the U.S. patent applications listed in Exhibit A
("U.S. Patent Applications") sufficiently cover the rights to manufacture
(produce), market and sell the Anti-Serum in the U.S., (iii) the U.S.
Patent Applications, when granted, will preclude any other party from
making (producing), using or selling the Anti-Serum for indications covered
in the Patent Rights including, without limitation, HIV reactive alpha
fetoprotein or cross reactive alpha fetoprotein for other retroviruses, or
a significantly similar pharmaceutical agent for the same indications in
the U.S. without first seeking a license from Holmedco, (iv) that the AFP
Anti-Serum/Vaccine foreign patents or patent applications for a particular
country referenced in Exhibit A comprise a complete counterpart of the AFP
Anti-Serum/Vaccine U.S. Application, (v) that the PP-29 foreign patents or
patent applications for a particular country referenced in Exhibit A
comprise a complete counterpart of the PP-29 U.S. Application, and (vi)
that the Modified PP-29 foreign patents or patent applications for a
particular country referenced in Exhibit A comprise a complete counterpart
of the Modified PP-29 U.S. Application.
4.4 COVENANT AGAINST GRANTING INTERESTS TO THIRD PARTIES. During the
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tenn of this Agreement, neither Edenland nor Owner will grant interest in
the Patent Rights, Know-How or Background Technology to any other person or
entity.
4.5 COOPERATION WITH DUE DILIGENCE INVESTIGATION. Subject to
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Holmedco's payment of all reasonable out-of-pocket expenses in accordance
with Section 2.3 above, Owner and Licensor shall cooperate in all respects
with any due diligence review conducted in connection with any proposed
financing of Holmedco.
5. IMPROVEMENTS
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Holmedco and Owner and Licensor shall disclose to each other all
Improvements developed or discovered by any Party, including without
limitation any developmental results generated under this Agreement by
Holmedco during the term of this Agreement, immediately upon the
development or discovery of such Improvements or the generation of such
developmental results. All Owner and Licensor Improvements shall be part
of the rights licensed hereunder with no additional costs to Holmedco.
Holmedco hereby grants and agrees to grant, assign, transfer and convey
irrevocably to Owner all ownership interest in and to all such Improvements
developed or discovered by Holmedco during the tenn of this Agreement;
provided, that to the extent Owner or Licensor is remunerated by third
parties in respect of such Improvements made by Holmedco or its
sublicensees, Holmedco shall be the Party receiving such remuneration.
Nothing in this Agreement shall in any way affect the full and absolute
ownership of Owner with regard to the Patent Rights, Know-How and
Background Technology of Edenland and Holmedco acknowledges that Owner has
the full right, title and interest in the ownership of the said Patent
Right, Know-How and Background Technology subject to the assigned portions
granted to Edenland.
6. REGULATORY AFFAIRS
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6.1 OVERSIGHT OF REGULATION MATTERS. Holmedco shall be responsible
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for regulatory activities necessary for the development of the Products, in
each country in the Territory. Within a reasonable period after Holmedco
obtains financing of at least $10,000,000 U.S., Holmedco and Owner shall
interview prospective FDA consultants and shall engage the topchoice
consultant as soon as possible.
6.2 LICENSOR AND OWNER SUPPORT OF REGULATING ACTIVITIES. Licensor
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and Owner shall support, where it is possible, the regulatory activities of
Holmedco in all relevant countries in the Territory. At all times during
the term of this Agreement, the Licensor and Owner and Holmedco shall each
promptly after learning thereof notify the other in writing of any serious
or unexpected adverse reactions or side effects with respect to the
Products.
6.3 IND APPLICATIONS AND NDA'S. Holmedco shall file all new IND
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applications and NDA's in its own name. Upon the termination of this
agreement the ownership of Holmedco's IND applications and grants shall
become the property of Licensor. During and after the term of this
Agreement, the NDA's concerning the Products shall remain the property of
Holmedco. The Parties shall make joint announcements of all rND and NDA
approvals on the Products. Owner and Edenland will get full credit in all
publications for the invention, and will be kept fully involved in the
development, of any Product.
6.4 REPORTING OF ADVERSE REACTIONS. Holmedco and Licensor shall
------------------------------
comply in each country of the Territory with a common adverse reaction
reporting system to be agreed between the Parties and, if required, the
more stringent of the adverse reaction reporting requirements of: (a) the
U.S. Food and Drug Administration; or (b) the Food and Drug Law of the
relevant country.
7. INTELLECTUAL PROPERTY
---------------------
7.1 OWNERSHIP. Owner shall have and retain ownership of and title to
---------
all intellectual property rights in all inventions and discoveries (except
for inventions and discoveries which are independently developed by
Holmedco and not derived from or based on the Patent Rights and Know-How or
other intellectual property of Owner or the Licensor) relating to the
Products, Licensed Processes or Improvements, including without limitation
patents and other intellectual property relating to the Products, Licensed
Processes or Improvements, which are made, conceived, reduced to practice
or generated by the Parties or their respective affiliates, including
employees, agents and other representatives or contractors, in the course
of work performed under this Agreement and/or any other agreements between
the Parties relating to the Products or the Licensed Processes; provided,
however, Holmedco shall be the sole owner of all trademarks or service
marks arising from marketing and sale of the Products or any services
related thereto and shall have sole discretion for the naming of any
Products or related services. The Parties acknowledge that Holmedco
reserves certain rights under Section 5 above in the Improvements and under
Section 9.3 below in the Know-How, Background Technology and Improvements
(excluding Patent Rights).
7.2 PATENT PROSECUTION FOR EXISTING PATENT RIGHTS. Subject only to
---------------------------------------------
the assignments between Owner and Edenland, Owner shall have the exclusive
right and obligation to prepare, file, prosecute and maintain all patent
applications and patents relating to the Products, Licensed Processes,
Know-How, Background Technology or Improvements. New patent applications
(to be paid for by Licensee) shall be filed in such countries as shall be
mutually agreed upon in good faith by Edenland and Holmedco; Licensor and
Owner shall be free to file patent applications and prosecute patents in
countries not agreed to with Licensee at Licensor's or Owner's sole expense
(it being understood by the Parties that the rights arising therefrom shall
be considered Patent Rights under this Agreement). In determining where
and when new patent applications shall be filed, Edenland and Holmedco
shall consider (i) the size and profitability to Holmedco of market
segments that will be covered by the Patent Rights in a particular country,
(ii) the degree to which such protection sufficiently precludes Holmedco's
competitors from making, using or selling a product similar to the Product
to be covered by the Patent Rights in such country, (iii) Holmedco's
international plans for marketing and distributing the Product, and (iv)
the general commercial standards in the pharmaceutical industry for
determining in which countries to seek patent protection. Edenland agrees
to keep Holmedco fully informed at all levels of the patent application
process and, if reasonably requested by Holmedco, to withdraw or cease
prosecuting a patent application in a particular country unless Licensor or
Owner is willing to continue such patent prosecution at its sole expense.
If Licensor has not, within ninety (90) days after the written request of
Holmedco, prepared and filed a patent application in a country where
Edenland and Holmedco have agreed that an application shall be filed, then
Holmedco shall be entitled to prepare, file, prosecute and maintain such
patent applications and patents and Licensor and Owner shall cooperate
fully with Holmedco in connection therewith and execute all necessary
documents. Holmedco shall provide reasonable assistance to Owner to
facilitate the filing and maintenance of all such patent applications and
patents, and shall execute all documents which Owner deems necessary or
desirable therefore. Without prejudice to the above, all applications for
patents shall be drafted by a patent attorney nominated by Holmedco. Prior
to lodgment all patent applications shall be subject to review by patent
agents nominated by Edenland. The reasonable expenses of the patent
agents, as well as patent renewal and other maintenance fees, shall be
discharged by the Licensee.
7.3 CERTAIN INTELLECTUAL PROPERTY. Subject to Section 7.1 above,
-----------------------------
Edenland and Owner and Holmedco shall retain their rights to all
intellectual property rights in its own logos or name and other
intellectual property used in the development of the Products and Licensed
Processes, except as otherwise provided herein.
7.4 THIRD PARTY INFRINGEMENT.
------------------------
(a) Each Party shall promptly report in writing to each other
Party during the term of this Agreement any (i) known infringement or
suspected infringement of any of the Patent Rights, or (ii) unauthorized
use or misappropriation of Know-How or Background Technology by a third
party of which it becomes aware, and shall provide each other Party with
all available evidence support said infringement, suspected infringement or
unauthorized use or misappropriation.
(b) Except as provided in Section 7.4(d) below, Holmedco shall
have the right to initiate an infringement or other appropriate suit
anywhere in the world against any third party who at any time has
infringed, or is suspected of infringing, any of the Patent Rights or of
using without proper authorization all or any portion of the Know-How or
Background Technology. Holmedco shall give Edenland sufficient advance
notice of its intent to file said suit and the reasons therefore, and shall
provide Edenland with an opportunity to make suggestions and comments
regarding such suit. Holmedco shall keep Edenland promptly informed, and
shall from time to time consult with Edenland regarding the status of any
such suit and shall provide Edenland with copies of all documents filed in,
and all written communications relating to, such suit.
(c) Holmedco shall have the sole and exclusive right to select
counsel for any suit referred to in subsection (b) above and shall pay all
expenses of the suit, including without limitation attorneys' fees and
court costs but shall be entitled to receive and retain any damages,
royalties, settlement fees or other consideration (collectively,
"Infringement Proceeds"); provided, however, Holmedco shall remit to
Edenland such portion of the Infringement Proceeds as Holmedco and Edenland
may agree upon in light of Edenland's royalty rights under this Agreement
or, if they cannot agree on an amount, such amount as determined by the
arbitrator under Section 11 below. If necessary, Edenland shall be joined
as a party to the suit but shall be under no obligation to participate
except to the extent that such participation is required as the result of
being a named party to the suit. Edenland shall offer reasonable
assistance to Holmedco in connection therewith at no charge to Holmedco
except for reimbursement of reasonable out-of-pocket expenses, including
salaries of Edenland personnel, incurred in rendering such assistance.
Edenland shall have the right to participate and be represented in any such
suit by its own counsel at its own expense. Holmedco shall not settle any
such suit involving rights of Edenland without obtaining the prior written
consent of Edenland which consent shall not be unreasonably withheld.
(d) In the event that Holmedco elects not to initiate an
infringement or other appropriate suit pursuant to subsection (b) above,
Holmedco shall promptly advise Edenland of its intent not to initiate such
suit, and Edenland shall have the right, at the expense of Edenland, of
initiating an infringement or other appropriate suit against any third
party who at any time has infringed, or is suspected of infringing, any of
the Patent Rights or of using without proper authorization all or any
portion of the Know-How or Background Technology. In exercising its rights
pursuant to this subsection (d), Edenland shall have the sole and exclusive
right to select counsel and shall pay all expenses of the suit, including
without limitation attorneys' fees and court costs, and shall be entitled
to receive and retain the Infringement Proceeds; provided, however,
Edenland shall remit to Holmedco such portion of the Infringement Proceeds
as Holmedco and Edenland may agree upon in light of Holmedco's exclusive
license rights under this Agreement or, if they cannot agree on an amount,
such amount as determined by the arbitrator under Section 11 below. If
necessary, Holmedco shall be joined as a party to the suit but shall be
under no obligation to participate except to the extent that such
participation is required as a result of being named party to the suit. At
Edenland's request, Holmedco shall offer reasonable assistance to Edenland
in connection therewith at no charge to Edenland except for reimbursement
of reasonable out-of-pocket expenses, including salaries of Holmedco's
personnel, incurred in rendering such assistance. Holmedco shall have the
right to participate and be represented in any such suit by its own counsel
at its own expense.
8. EXCHANGE AND USE OF DATA
------------------------
8.1 DEVELOPMENT DATA. Each Party and its Affiliates shall provide
----------------
the other Parties with access to and (upon request) copies of all
information and data generated by it in connection with the development of
the Products or Combination Products, including without limitation all
information and data regarding Improvements and all information and data
filed with the U.S. FDA and all other applicable regulatory agencies in the
Territory, and each Party shall have the unrestricted right free of charge
to utilize the information and data or any portion thereof for any purpose
under this Agreement in its sole discretion.
8.2 STUDIES. Each Party shall make available to the other Parties
-------
all information and data relating to the unpublished or not-yet-published
studies on the Products or Licensed Processes at least four weeks prior to
any use of such information or data for marketing purposes. If data
becomes available which is required to be utilized immediately in order to
maintain commercial and scientific advantage a waiver from this Section
must be obtained in writing prior to the use of the said data.
8.3 IMPROVEMENTS. All parties shall have the unrestricted right to
------------
use all information and data generated by the other relating to the
Products or Licensed Processes as set forth under Section 5 at no cost
within the Territory.
8.4 PUBLICATIONS. No Party shall submit for written or oral
------------
publication any proprietary data or other proprietary information in
violation of Section 8.5 below. To ensure compliance with the provisions
of this Section 8.4, the Party proposing to submit such publication shall
provide the other Parties a reasonable opportunity to review the proposed
submission prior to its publication. Notwithstanding the above, the Owner
has made all Parties to this Agreement aware of both a substantial
autobiography contract with Transworld Publishers and a BBC Documentary
concerning his research work in relation to HIV. In the course of
completing the above two contracts, the Owner will keep all Parties
informed of developments; however, Owner is not in a position, due to his
signed contract's with the Publishers and the BBC, to allow the other
parties to this License Agreement the opportunity to review the
autobiography or film prior to either publication. Access for filming and
interviews will be required during patient testing at test sites. No
proprietary information will be disclosed by Owner. The Owner is at
present in negotiations concerning film rights to the above autobiography.
8.5 CONFIDENTIAL INFORMATION. During the term of this Agreement and
------------------------
for five (5) years thereafter, no Party shall, without the specific written
consent of all parties, disclose to any other person (except disclosures
required by law and disclosures to Affiliates and third persons workings as
outside contractors to such Party under confidentiality obligations
consistent with those set forth in this Section 8.5) any confidential
information or trade secret concerning the Products or Licensed Processes
(including the Know-How and Background Technology) or another Party's
business that is subject to, or obtained or developed in the course of
performing, this Agreement unless such information: (a) was or becomes
public through no fault of the receiving Party; (b) was, at the time of
receipt, already in the receiving Party's possession as evidenced by
written records; or (c) was obtained from a third party legally entitled to
use and disclose the same. Upon termination of this Agreement, each Party
shall forthwith return to the appropriate other Party all physical
manifestations of any confidential information or trade secrets in its
possession or control which are owned or assigned by such other Party
except as otherwise provided in Section 9.3 below.
9. TERM AND TERMINATION
--------------------
9.1 TERM. This Agreement shall remain in effect, unless sooner
----
terminated as set forth in Section 9.2 below, until the later of (a) the
expiration of the last to expire Patent Right and (b) ten (10) years from
the date of the first commercial sale of the Products by Holmedco
hereunder.
9.2 TERMINATION.
------------
(a) This Agreement shall automatically terminate with regard to
a specific Product if that Product is permanently and completely withdrawn
from all markets in the Territory for serious adverse health or safety
reasons.
(b) Licensor may terminate this Agreement immediately upon
written notice if, at any time, Holmedco shall be involved in financial
difficulties as exclusively evidenced by the filing in any court pursuant
to any statute of the United States or of any individual state or foreign
country a petition in bankruptcy or insolvency or for reorganization or for
an arrangement or for the appointment of a receiver or trustee of the
Licensee or of its assets; or if Holmedco proposes a written agreement of
composition for extension of its debts; or if Holmedco shall be served with
an involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within sixty (60) days after the
filing thereof; or if Holmedco shall propose or be a party to any
dissolution or liquidation, or if Holmedco shall make an assignment for the
benefit of its creditors.
(c) In the event either of Edenland or Owner materially breaches
any term or provision of this Agreement, Holmedco may and, in the event
Holmedco materially breaches any term or provision of this Agreement,
either of Edenland or Owner may, terminate this Agreement thirty (30) days
after giving the breaching Party written notice of such breach, unless: (i)
the breaching Party cures the breach within such 30-day period; or (ii) if
a cure cannot reasonably be effected within such 30-day period, the
breaching Party commences the cure of such breach within such 30-day period
and diligently prosecutes such cure to completion. This thirty (30) day
cure period shall not apply to a breach by Holmedco to meet the terms of
Section 3.1 of this Agreement; provided, however, no arbitration or legal
recourse shall be available to Holmedco or Edenland as a result of
Holmedco's inability to meet the conditions under Section 3.1 or this
Agreement.
9.3 RIGHTS AND DUTIES UPON TERMINATION. The following Sections shall
----------------------------------
survive termination of this Agreement: Sections 5, 7.1, 7.3, 9.3, 10, 11,
and 13.1 through 13.10, inclusive. Further, upon termination of this
Agreement by Edenland or Owner pursuant to Sections 9.2(b) or 9.2(c) or
Section 12 below, Holmedco shall return to each of Edenland and Owner all
of its respective Intellectual Property received by Holmedco, as well as
all information generated by any Party in the course of its performance
hereunder, including any Patent Rights, Know-How, Improvements, development
studies and other information generated or developed in the course of
performance of this Agreement (except for information which if
independently developed by Holmedco and not derived from or based on the
Patent Rights, Know-How or other Intellectual Property of either of
Licensor or Owner and except for any trademarks or service marks relating
to the Products or services related thereto which shall be owned solely by
Holmedco). Upon such termination and return of Intellectual Property and
other information, Holmedco shall have no further rights to or interest in
the Patent Rights, Know-How, Improvements, the Products, the Licensed
Processes, or the IND's granted. If this Agreement expires naturally
within the complete Territory in accordance with its tenn as provided in
Section 9.1, Holmedco is hereby granted a non-exclusive perpetual license
to use the Know-How, Background Technology and Improvements (excluding
Patent Rights).
10. INDEMNIFICATION
---------------
10.1 BREACH OF REPRESENTATION, WARRANTY OR COVENANT; ACTS AND
--------------------------------------------------------
OMISSIONS: INFRINGEMENT. Edenland and Owner shall indemnify Holmedco and
-----------------------
its Affiliates and Holmedco shall indemnify Edenland and Owner against any
and all claims, suits, actions or threats of action, liabilities,
settlement amounts, damages, expenses or costs of any kind whatsoever,
including without limitation reasonable attorneys' fees and costs
(collectively "Damages"), which result from or arise out of (a) any
inaccuracy of a representation, or breach of a warranty, made by the
indemnifying Party under this Agreement, (b) the indemnifying Party's
failure to perform any covenant which it is required to perform under this
Agreement, and (c) intentional or grossly negligent actions or omissions,
misconduct or wrongdoing by the indemnifying Party, its Affiliates or their
agents in its performance under this Agreement. In addition, Edenland and
Owner shall indemnify Holmedco and its Affiliates from any and all third
party claims arising from the Patent Rights, Know-How, and Background
Technology, including without limitation, any claims that they infringe
upon any rights of third persons. The indemnification provisions of this
Section 10.1 shall also cover the indemnified Party's directors, officers,
employees and other agents that may suffer any Damages. Owner and Licensor
agree that the indemnification provisions of this Section 10.1 shall not
apply to any failure by Holmedco to make the payments under Section 2.2
hereof and that Owner's and Licensor's exclusive remedy for such failure
shall be the right to terminate this Agreement in accordance with Section
9.2(c).
10.2 THIRD PARTY CLAIMS. Upon receiving notice of any claim or suit
------------------
under Section 10 above, the indemnified Party shall immediately notify the
indemnifying Party and shall allow the indemnifying Party and/or its
insurer the opportunity to assume direction and control of the defense of
such claim, including without limitation the settlement thereof at the sole
option of the indemnifying Party or its insurer. The indemnified Party
agrees to co-operate with the indemnifying Party in the conduct of any
negotiations, dispute resolution or litigation of any such claim or suit;
and the indemnifying Party shall inform the indemnified Party of the
progress of the claim or suit at such time and in such manner as is
reasonable under the circumstances. Notwithstanding anything to the
contrary herein, Edenland or Owner, if it is the indemnified Party, shall
at all times have the right to assume the loss and expense of any
litigation relating to the Products or Licensed Processes and thereby
control the contest and defense thereof.
10.3 INSURANCE. To the extent each party may have such insurance, for
---------
the applicable term and of this Agreement, each Party agrees to make the
other Party a named insured under its product liability insurance and
clinical trial/malpractice insurance.
11. ARBITRATION
-----------
The parties to any dispute or controversy arising out of, in
connection with or relating to this Agreement, its negotiation, performance
or breach, shall attempt to resolve any such dispute in an amicable manner,
failing which the Parties shall submit the same to arbitration. The
arbitration panel shall consist of one arbitrator and shall be formed in
accordance with the Rules for Commercial Arbitration of the American
Arbitration Association then obtaining (the "Rules"). The arbitration
shall be held in the State of Washington pursuant to the Rules, and the
award shall be rendered in such form that judgment may be entered thereon
in the highest court of any forum, state, federal or foreign, having
jurisdiction. In making its award, the arbitrator shall be guided, in
descending order of priority, by the terms of this Agreement, the usages of
the trade in the business in which Edenland, Owner and Holmedco are engaged
and what is just and equitable under the circumstances. The cost of such
arbitration shall be borne by the party against which an award is rendered
in the arbitration proceeding or as the arbitrator may determine.
Notwithstanding anything to the contrary contained herein, either party may
apply to a court of competent jurisdiction for equitable relief for any
breach or threatened breach of this Agreement, including but not limited to
restraining orders and affirmative injunctive relief, and for ancillary
orders in aid of the arbitrator.
12. FORCE MAJEURE
-------------
Neither Party shall be liable for failure to perform any activities
hereunder if such failure is due to a cause beyond the reasonable control
of such Party, including without limitation, strikes, lockouts or other
labor disturbances, riots, floods, fires, accidents, wards, embargoes,
delays of carriers, inability to obtain materials from sources of supply,
acts, or injunctions (each a "Force Majeure Event"). Upon the occurrence
of any Force Majeure Event, the Party whose performance is affected shall
immediately given written notice of such Force Majeure Event to the other
Party, and shall thereafter exert all reasonable efforts to overcome such
Force Majeure Event and resume performance of this Agreement. If, despite
such efforts the Party is unable to perform six (6) months following
notification given hereunder, then the other Party may terminate this
Agreement.
13. MISCELLANEOUS
-------------
13.1 ASSIGNMENT. Except as provided above, no Party may assign this
----------
Agreement except upon prior written consent of the Owner. Notwithstanding
the foregoing, any Party may assign its rights and obligations to an
Affiliate upon 30 days prior written notice of such assignment to the other
parties, although no such assignment shall relieve the Party of its primary
responsibility for performance hereunder. Licensor shall not be permitted
to make any, complete or partial, assignment of this Agreement for the
benefit of Licensor's creditors.
13.2 WAIVER. The failure of any Party hereto at any time to acquire
------
performance by another Party of any provision of this Agreement shall not
affect the right of such Party to require future performance of that
provision. Any waiver by any Party of any breach of any provision of this
Agreement must be in writing to be effective and shall not be construed as
a waiver of any continuing or succeeding breach of such provision, a waiver
of the provision itself, or a waiver of any right under this Agreement.
13.3 GOVERNING LAW. This Agreement shall be governed by and construed
-------------
in accordance with the laws of the State of Washington, U.S.A.
13.4 ENTIRE AGREEMENT. This Agreement and any other written
----------------
agreements between the Parties signed on or after the date hereof and
relating to the subject matter hereof constitute the entire understanding
of the Parties hereto and supersede all previous agreements between the
Parties with respect to the matters contained herein. No modifications of
this Agreement shall be binding upon any Party unless approved in writing
by an authorized representative of each of the Parties.
13.5 PARTIAL INVALIDITY. In case any one or more of the provisions
------------------
contained herein shall, for any reason, be held to be invalid, illegal or
unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provisions of this Agreement,
but this Agreement shall be construed as if such invalid, illegal or
unenforceable provision or provisions had never been contained herein
unless the deletion of such provision or provisions would result in such a
material change as to cause completion of the transaction contemplated
herein to be impossible.
13.6 EFFECTIVENESS. This Agreement shall become effective immediately
-------------
upon execution and delivery by the Parties.
13.7 EXECUTION IN COUNTERPARTS. This Agreement may be executed in one
-------------------------
or more counterparts, all of which shall be considered one and the same
agreement, and shall become a binding agreement when one or more
counterparts have been signed by each of the parties and delivered to the
other party.
13.8 BUY-OUT. In the event Holmedco is acquired by merger, asset
-------
acquisition or stock acquisition, Holmedco shall take all steps necessary
to ensure the acquirer assumes the obligations of Licensee under the
license agreement. In the event Edenland is acquired by merger, asset
acquisition or stock acquisition, Edenland shall take all steps necessary
to ensure the acquirer assumes the obligations of Edenland under the
license agreement.
13.9 SET-OFF. In the event any Party is owed any sums which are not
-------
paid when due under this Agreement, the Development Agreement or any other
agreement or note between the parties, such Party may set-off such amounts
against any payments due the other Party hereunder.
13.10 NOTICES. Except as otherwise provided herein, any notice or
--------
other communications sent or delivered hereunder shall be in writing and
shall be effective if hand-delivered or if sent by certified or registered
mail or postage prepaid or by international courier service:
To Edenland: Edenland Inc.
-----------
Xxxxxxx, Xxxxxxxx
Xxxxxx Xxxxxxx, Xxxxxxx
Attention: Xx. Xxx X. Xxxxxxxxxxx
Telephone: 000-0-0000000
Telecopier: 000-0-0000000
To Owner: Xxxxxxx X. Xxxxxxxxxxx
--------
Xxxxxxx, Xxxxxxxx
Xxxxxx Xxxxxxx, Xxxxxxx
Telephone: 000-0-0000000
Telecopier: 000-0-0000000
To Holmedco: Holmedco Pharmaceuticals Corporation
-----------
0000 XX 000xx Xxxxxx
Xxxxxxxxx XX 00000
Attention: Xxxxxxx X. Xxxxxx, Chairman and CEO
Telephone: 000-000-0000
Telecopier: 000-000-0000
or to such address as any Party shall hereafter designate by notice to the
other Parties. A notice shall be deemed to have been given on the date of
receipt by the Party.
13.11 INTELLECTUAL PROPERTY OF OWNER'S SPOUSE. The Parties
---------------------------------------
acknowledge that Owner's spouse is also a microbiologist. The Parties
further acknowledge and agree that nothing in this Agreement is intended to
confer to any Party an interest in any of the intellectual property rights
of Owner's spouse that relate to her cancer research projects or any other
project unrelated to the development of the Products.
IN WITNESS WHEREOF, the Parties have caused this License Agreement to
be signed by their duly authorized representatives as of the day and year
first above written.
"LICENSEE" "LICENSOR"
HOLMEDCO PHARMACEUTICALS EDENLAND INC.
CORPORATION
BY: /s/ Xxxxxxx X. Xxxxxx BY: /s/ Xxx Xxxxxxxxxxx
------------------------------ ------------------------------
ITS: Chairman & CEO ITS: Secretary/Director
------------------------------ ------------------------------
Only for Purposes of Section
3.11 of this Agreement
"OWNER" "XXXXXX"
/s/ Xxxxxxx X. Xxxxxxxxxxx /s/ Xxxxxxx X. Xxxxxx
------------------------------------ -----------------------------------
XXXXXXX X. XXXXXXXXXXX
EXHIBIT A
---------
PATENTS AND PATENT APPLICATION
------------------------------
===================================================================
PATENT NO.
COUNTRY STATUS APPLICATION NO.
-------------------------------------------------------------------
1. AFP ANTI-SERUM/VACCINE
-------------------------------------------------------------------
Aripo Pending AP/P/91-00309
-------------------------------------------------------------------
Australia Pending 81268/91
-------------------------------------------------------------------
Bolivia Pending Not Yet Assigned
-------------------------------------------------------------------
Canada Pending 2,047,61B
-------------------------------------------------------------------
Europe Pending 91 112 320.6-2116
-------------------------------------------------------------------
Honduras Pending Not Yet Assigned
-------------------------------------------------------------------
Ireland Pending 1427/90
-------------------------------------------------------------------
Ireland Pending 940256
-------------------------------------------------------------------
Oapi Pending PV.60045
-------------------------------------------------------------------
U.S. Pending 08/007,128 (CIP of
07/734,567)
-------------------------------------------------------------------
U.S. Pending 07/734,567
-------------------------------------------------------------------
2. PP-29
-------------------------------------------------------------------
Australia Accepted 636,574
-------------------------------------------------------------------
Canada Pending 609,342
-------------------------------------------------------------------
Europe Pending 89 115 606.9-2107
-------------------------------------------------------------------
Ireland Pending 2585/88
-------------------------------------------------------------------
Israel Pending 91415
-------------------------------------------------------------------
Japan Pending 220158/89
-------------------------------------------------------------------
Oapi Pending PV 59631
-------------------------------------------------------------------
Philippines Pending 00000
-------------------------------------------------------------------
Xxxxx Xxxxxx Patented 89/06450
-------------------------------------------------------------------
South Korea Pending 12173/89
-------------------------------------------------------------------
U.S. Pending 08/026,196
-------------------------------------------------------------------
3. MODIFIED PP-29
-------------------------------------------------------------------
Aripo Pending AP/P/91-00316
-------------------------------------------------------------------
Australia Pending 79204/91
-------------------------------------------------------------------
Bolivia Pending Not Yet Assigned
-------------------------------------------------------------------
Canada Pending 462,621
-------------------------------------------------------------------
Europe Pending 91 110263.0-2107
-------------------------------------------------------------------
Honduras Pending Not Yet Assigned
-------------------------------------------------------------------
Ireland Pending 2244/90
-------------------------------------------------------------------
Oapi Pending PV.60024
-------------------------------------------------------------------
Philippines Pending 42669
-------------------------------------------------------------------
U.S. Allowed 07/719,017
===================================================================
AMENDMENT NO. 1 TO
LICENSE AGREEMENT
This Amendment is made as of this 5th day of February 1995, by and
between EDENLAND, lNC, a Delaware corporation ("Edenland" or "Licensor"),
XXXXXXX X. XXXXXXXXXXX, an individual ("Owner"), and XXXXXX-XXXX, INC, a
Delaware corporation (formerly Holmedco Pharmaceuticals Corporation) (the
"Xxxxxx-Xxxx").
W I T N E S S E T H:
--------------------
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx are parties to that certain
License Agreement dated August 25, 1994 ("Agreement").
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx desire to amend the Agreement
in the manner set forth herein.
NOW, THEREFORE, in consideration of the premises, the provisions and
the respective agreements hereinafter set forth, the parties hereby agree
as follows:
1. In consideration of Licensor entering into this Amendment,
Xxxxxx-Xxxx shall issue Licensor a five year Warrant to purchase up to
100,000 shares of Xxxxxx-Xxxx'x Common Stock (after the reverse stock
split contemplated by Xxxxxx-Xxxx to reduce the total outstanding
shares of Xxxxxx-Xxxx'x Common Stock from 15,000,000 to 9,000,000) at
an exercise price of $6.00 per share. Licensor shall also be granted
the same SEC registration rights (to give Licensor more flexibility in
its ability to sell any shares purchased after exercise of such
Warrant) granted to the investors in Xxxxxx-Xxxx'x first round of
equity financing.
2. Subsection (c) of Section 2.2 is hereby deleted and replaced with
the following subsection (c):
"(c) Payment to Licensor of U.S. $572.000 as provided
in Section 3.1."
3. The first sentence (including the proviso) of Section 3. 1 of the
Agreement is hereby deleted in its entirety and replaced with the
following first sentence:
"Licensing fee of U.S. Five Hundred Seventy Two
Thousand Dollars ($572,000) to be paid as follows: One
Hundred Fifty Thousand Dollars ($150,000) due on
February 15, 1995 and payable no later than February
28, 1995, Three Hundred Thousand ($300,000) due and
payable on February 28, 1995 and the remaining One
Hundred Twenty Two Thousand Dollars ($122,000) due on
March 15, 1995 and payable no later than March 31,
1995.
4. The parties agree that the Anti-Serum shall cease to be a Product
subject to the License Agreement if Xxxxxx-Xxxx has not contributed at
least U.S. $3,000,000 to the development of the Anti-Serum in accordance
with the terms and conditions of Section 5.2 of the Development Agreement,
as amended by Amendment No. 1 to such agreement.
5. Except as specifically set forth herein, the Agreement shall
remain unaffected and shall remain in full force and effect. This
Amendment shall be deemed part of, and construed in accordance with, the
Agreement.
IN WITNESS WHEREOF, the parties have executed this Amendment and
caused the same to be duly delivered on their behalf on the day and year
hereinabove first set forth.
"Xxxxxx-Xxxx" "Edenland" or "Licensor"
XXXXXX-XXXX, INC EDENLAND, INC.
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
--------------------------------- --------------------------------
Its: CEO Its: Director
--------------------------------- -------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
------------------------------------
XXXXXXX X. XXXXXXXXXXX
AMENDMENT NO. 2 TO
LICENSE AGREEMENT
This Amendment is made as of this 28th day of February 1995, by
and between EDENLAND, INC., a Delaware corporation ("Edenland" or
"Licensor"), XXXXXXX X. XXXXXXXXXXX, an individual ("Owner"), and
XXXXXX-XXXX, INC., a Delaware corporation (formerly Holmedco
Pharmaceuticals Corporation) ("Xxxxxx-Xxxx").
W I T N E S S E T H:
-------------------
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx are parties to that
certain License Agreement dated August 25, 1994, as amended by that certain
Amendment No. 1 to License Agreement dated February 5, 1995 ("Agreement");
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx desire to amend the
Agreement in the manner set forth herein;
NOW, THEREFORE, in consideration of the premises, the provisions
and the respective agreements hereinafter set forth, the parties hereby
agree as follows:
1. It is a condition precedent to the effectiveness of this
Amendment that the payment per Section 2.2(b) which became payable on
February 1, 1995 be transmitted to Licensor's account no later than
February 28, 1995. Failure to make this payment shall invalidate this
Amendment which facilitates an extension, as outlined in Section 3, to
the termination of the Agreement.
2. In consideration of Licensor entering into this Amendment,
Xxxxxx-Xxxx shall immediately issue to Licensor One Hundred Thousand
(100,000) shares of Xxxxxx-Xxxx'x Common Stock.
3. The first sentence (including the proviso) of Section 3.1 of the
Agreement . is hereby deleted in its entirety and replaced with the
following first sentence:
"Licensing fee of U.S. Five Hundred Seventy Two
Thousand Dollars ($572,000) payable on or before March
17, 1995."
4. Except as specifically set forth herein, the Agreement shall
remain unaffected and shall remain in full force and effect. This
Amendment shall be deemed part of, and construed in accordance with,
the Agreement.
IN WITNESS WHEREOF, the parties have executed this Amendment and
caused the same to be duly delivered on their behalf on the day and year
hereinabove first set forth.
"Xxxxxx-Xxxx" "Edenland" or "Licensor"
XXXXXX-XXXX, INC. EDENLAND, INC.
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
--------------------------------- --------------------------------
Its: CEO Its: Director
-------------------------------- -------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
------------------------------------
XXXXXXX X. XXXXXXXXXXX
AMENDMENT NO. 3
TO LICENSE AGREEMENT
This Amendment is made to be effective as of the 17th day of March
1995, by and between EDENLAND, INC., a Delaware corporation ("Edenland" or
"Licensor"), XXXXXXX X. XXXXXXXXXXX, an individual ("Owner"), and
XXXXXX-XXXX, INC., a Delaware corporation (formerly Holmedco
Pharmaceuticals Corporation) ("Xxxxxx-Xxxx").
W I T N E S S E T H:
--------------------
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx are parties to that certain
License Agreement dated August 25, 1994, as amended by that certain
Amendment No. 1 to License Agreement dated February 5, 1995 and that
certain Amendment No. 2 to License Agreement dated February 28, 1995 (as
amended, the "Agreement");
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx desire to amend the Agreement
in the manner set forth herein;
NOW, THEREFORE, in consideration of the premises, the provisions and
the respective agreements hereinafter set forth, the parties hereby agree
as follows:
1. It is a condition precedent to the effectiveness of this
Amendment that the U.S. $125,000 payment per Section 3.1 of the
Agreement, as amended below, be transmitted to the account of Licensor
no later than March 27th, 1995. Failure to make this payment shall
invalidate this Amendment. The parties providing the said funding
shall confirm in writing to Licensor their agreement to wire transfer
said funds not later than March 26th 1995.
2. The first sentence of Section 3.1 of the Agreement is hereby
deleted in its entirety and replaced with the following first
sentence:
"Licensing fee of U.S. Five Hundred Seventy Two
Thousand Dollars ($572,000) payable as follows: U.S.
$125,000 on or before March 27th, 1995 and the
remaining U.S. $447,000 is due and payable as per
Section 3 of Amendment No. 3 to the Xxxxxxxxx, License
Agreement dated 17th, March, 1995."
3. Xxxxxx-Xxxx shall make any necessary payments, commencing as soon
as working capital is available to Xxxxxx-Xxxx but not later than
August 1995, due per clause 7.2 of the Edenland License Agreement in
order to protect the World Patent Rights granted to Xxxxxx-Xxxx per
the said Agreement. These payments shall be in the order of $5,000
per month and shall not be deductible from the fees payable under
Section 2 above.
4. Except as specifically set forth herein, the Agreement shall
remain unaffected and shall remain in full force and effect. The
conditions of this Amendment shall become part of the original
Agreement and its Terms.
IN WITNESS WHEREOF, the parties have executed this Amendment and
caused the same to be duly delivered on their behalf on the day and year
hereinabove first set forth.
"Xxxxxx-Xxxx" "Edenland" or "Licensor"
By /s/ Xxxxxxx X. Xxxxxx By /s/ Xxx Xxxxxxxxxxx
---------------------------------- ---------------------------------
Its CEO Its Director
---------------------------------- --------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
------------------------------------
XXXXXXX X. XXXXXXXXXXX
PAGE 1 OF 1
AMENDMENT NO. 4 TO
LICENSE AGREEMENT
This Amendment is made to be effective as of the day of August,
1995, by and between EDENLAND, INC., a Delaware corporation ("Edenland" or
"Licensor"), XXXXXXX X. XXXXXXXXXXX, an individual ("Owner"), and XXXXXX-
XXXX, INC., a Delaware corporation (formerly Holmedco Pharmaceuticals
Corporation)("Xxxxxx-Xxxx").
W I T N E S S E T H:
--------------------
WHEREAS, Licensor, Owner and Xxxxxx-Xxxx desire to amend the Agreement
in the manner set forth herein;
NOW, THEREFORE, in consideration of the premises, the provisions and
the respective agreements hereinafter set forth, the parties hereby agree
as follows:
1. Section 3.1 of the Edenland Agreement is hereby replaced with the
following:
"The Licensing Fee requirements of the Edenland
Agreement shall be satisfied by payment of the fees due
per Section 3.1 Amendment No. 5 of the Xxxxxxxxx
Agreement."
2. Except as specifically set forth herein, the Agreement shall
remain unaffected and shall remain in full force and effect. The
conditions of this Amendment shall become part of the original
Agreement and its Terms.
IN WITNESS WHEREOF, the parties have executed this Amendment and
caused the same to be duly delivered on their behalf on the day and year
hereinabove first set forth.
"Xxxxxx-Xxxx" "Edenland" or "Licensor"
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
--------------------------------- --------------------------------
Its: CEO Its: Director
--------------------------------- -------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
------------------------------------
XXXXXXX X. XXXXXXXXXXX
