Exhibit 10.7
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made as of the 18th day of May
1994, by and between XXXXXXXXX LIMITED, a corporation duly organized and
existing under the laws of Delaware (hereinafter "Xxxxxxxxx") (Xxxxxxxxx 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 to be duly formed and organized by Xxxxxxx X. Xxxxxx and
existing under the laws of Delaware hereinafter ("Holmedco" and/or
"Licensee") (each a "Party" and collectively the "Parties"). Capitalized
terms shall have the meanings given them in Section I of this Agreement.
WHEREAS, Owner is the full owner of Patent Rights and Know-How (each
as defined below) and as of April 19th, 1994 the following patents were
granted to Xxxxxxx X. Xxxxxxxxxxx:
Country Patent No.
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United States of America 4,956,355
Australia 608824
Belgium 1004315
Canada 564,245
Greece 88 01 00248
Israel 00000
Xxxxx 1.227.073
Luxembourg 87.202
New Zealand 224272
Oapi 00000
Xxxxxxxxxxx 00000
Xxxxxxxx 00000
Xxxxx Xxxxxx 00/0000
Xxxxxxxxxxx 000000
Xxxxxx Xxxxxxx 2 204 237 B
France 8805043
Patent applications are pending (none are under prior art rejection)
in the following countries:
Country Application No.
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Austria A984/88
Xxxxxxx 0000/00
Xxxxxxx P 38 12 595.1
Ireland 997/87
Xxxxx 00000/00
Xxxxxxxxxxx 8800926
Xxx Xxxxxxx 000000
Xxxxx Xxxxx 00-0000
Xxxxxx 8801406-3
WHEREAS, Xxxxxxxxx has been assigned Owner's rights in the Patent
Rights and Know-How relating to the treatment of human/animal
immunodeficiency as disclosed in U.S. Patent No. 4,956,355 entitled "Agents
for the Arrest and Therapy of Retrieval Infections," the said assignment
between Xxxxxxxxx and Owner allows Xxxxxxxxx sufficient portion of rights
to grant licenses to make, use, exercise and vend the Products and Licensed
Processes (as defined below); and
WHEREAS, Xxxxxxxxx has been granted an Investigational New Drug (IND)
status from the U.S. Food and Drug Authority for the use of the technology
outlined in the U.S. Patent No. 4,956,355 in the treatment of HIV
infection, IND No. 31,980; and
WHEREAS, Holmedco desires to obtain a license under the Patent Rights
and Know-How upon the outlined terms and conditions hereinafter set forth.
NOW, THEREFORE, the Parties hereby agree as follows:
1. DEFINITIONS
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1.1 "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.
1.2 "BACKGROUND TECHNOLOGY" shall mean all Elements of Technology (as
defined below) that are necessary or useful to commercialize and exploit
the Products and that Xxxxxxxxx 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.
1.3 "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.
1.4 "COMBINATION PRODUCT NET SALES" shall have the meaning given that
term in the definition for "Product Revenues."
1.5 "COMBINATION SUBSTANCES" shall mean the product or substance,
other than a Product, that is sold in combination with a Product.
1.6 "DAMAGES" shall have the meaning given to it in Section 11.1.
1.7 "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.
1.8 "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.
1.9 "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.
1.10 "FORCE MAJEURE EVENT" shall have the meaning given it in Section
13.
1.11 "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.
1.12 "INFRINGEMENT PROCEEDS" shall have the meaning given that term in
Section 8.4.
1.13 "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 this Agreement, BUT EXCLUDING any (i)
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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.
1.14 "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.
1.15 "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.
1.16 "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.
1.17 "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.
1.18 "PATENT RIGHTS" shall mean all of each of the Licensor's and
Owner's rights in the following intellectual property:
(a) the United States and foreign patents and/or patent
applications listed in Recitals.
(b) United States and foreign patents issued from the
applications listed in Recitals and from divisional and continuations of
the applications;
(c) claims of US. and foreign patents issued from the
applications, and of the resulting patents, which are directed to subject
matter specifically described in the U.S. and foreign applications listed
in Recitals.
(d) claims of all foreign patent applications, and of the
resulting patents, which are directed to subject matter specifically
described in the United States patents and/or patent applications 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.
1.19 "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 in which any Product is to be made, used or sold; 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.
1.20 "PRODUCT APPROVAL" means final FDA approval to market
commercially the specified product for use by humans or animals.
1.21 "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 July 1988)
for sales of Products treating terminally ill patients, prior to United
States Product Approval, shall be utilized in calculating royalties due.
1.22 "RULES" shall have the meaning given that term in Section 12.
1.23 "TERRITORY" shall mean the world.
2. LICENSE GRANT
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2.1 LICENSE GRANT. Xxxxxxxxx and Owner hereby jointly grant to
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Holmedco the exclusive world rights (even as to Xxxxxxxxx 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, and to sublicense others to do the same, 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 a license fee upon signing this
Agreement of $100,000;
(b) Payment to Licensor of $250,000 as provided in Section 3.1.
2.3 PROGRESS REPORTS ON FUNDING. During the first six months of this
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Agreement and any extension thereof, Holmedco shall furnish to Xxxxxxxxx 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 including the sublicensing of
Holmedco's rights under this Agreement.
3. LICENSE TERMS
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The terms of the License Agreement, are as set out hereunder:
3.1 $250,000 LICENSE FEE. Licensing fee of US. Two Hundred Fifty
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Thousand Dollars ($250,000) to be paid not later than 18th, November 1994;
provided, however, that date shall be extended for a reasonable period of
time to permit Holmedco to close its initial financing, if Holmedco
demonstrates that it has used reasonable efforts to secure financing which,
without limitation, can be demonstrated by preliminary letters of intent
from accredited investors. Contemporaneously with payment in full of such
license fee, Xxxxxxxxx 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 Xxxxxxxxx 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 Xxxxxxxxx royalties of six (6%)
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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.
3.3 ROYALTIES ON SUBLICENSES. In the event of the sale of sublicenses
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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
Xxxxxxxxx.
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 six percent (6%) royalty due under Section 3.2 shall be
reduced to three percent (3%) 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 (1Oth)
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. A renewable annual license fee of
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$500,000 shall be payable commencing eighteen (18) months after Holmedco
pays the $250,000 required under Section 2.2. This fee amount is deductible
from royalty payments, due as per Section 3.2, which become payable in the
12-month period following renewal of license. Holmedco may deduct from this
annual fee an amount equal to any payments made under Section 3.3 above.
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 Xxxxxxxxx a detailed report
detailing the amount of all royalties owing to Xxxxxxxxx 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 Xxxxxxxxx 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 Xxxxxxxxx prior to
transmission of funds from countries within the Territory that may result
in the deduction of withholding taxes.
3.7 XXXXXXXXX'X RIGHT TO INSPECT RECORDS. Xxxxxxxxx or its
------------------------------------
authorized 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 Xxxxxxxxx
hereunder and the accuracy of the information provided to Xxxxxxxxx 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 Xxxxxxxxx.
3.8 ROYALTIES IN COUNTRIES PROHIBITING TRANSFER OF CURRENCY ABROAD.
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Where royalties are due Xxxxxxxxx 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 Xxxxxxxxx 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 Xxxxxxxxx in an accredited bank in that country that
is acceptable to Xxxxxxxxx.
4. CERTAIN REPRESENTATIONS. WARRANTIES AND COVENANTS OF OWNER AND
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LICENSOR.
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4.1 PATENT RIGHTS. KNOW-HOW AND BACKGROUND TECHNOLOGY. Xxxxxxxxx and
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Owner represent that they are the only persons who hold any interest in the
Patent Rights, Know-How and Background Technology, that such information is
not based upon any non-public information obtained from any other person,
that they are the true and first inventors of the invention described in
the Patent Rights, that there are no lawful grounds of objection to the
grant of the Patent Rights, that they have not done or omitted any act to
obtain the Patent Rights which would impair the validity of the Patent
Rights, that there are no encumbrances or liens thereon, that execution of
this License Agreement is duly authorized and does not breach any agreement
with any third person or entity, or any applicable law or regulation.
Neither Xxxxxxxxx nor Owner will grant any other person any right or
portion thereof in the Patent Rights, Know-How or Background Technology to
any other person or entity. Xxxxxxxxx and Owner represent that their Patent
Rights are for all uses of their invention for the arrest and therapy of
human retroviral infections and not limited to use for HIV and AIDS.
4.2 COVENANT AGAINST GRANTING INTERESTS TO THIRD PARTIES. During the
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term of this Agreement, neither Xxxxxxxxx nor Owner will grant interest in
the Patent Rights, Know-How or Background Technology to any other person or
entity.
4.3 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 term 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 Xxxxxxxxx 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 Xxxxxxxxx.
6. DEVELOPMENT AND COMMERCIALIZATION.
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6.1 DEVELOPMENT COSTS. The Parties recognize that Licensor and Owner
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have performed certain preclinical and clinical development work on the
Products. Holmedco shall, at its own expense, be responsible for the
development of the Products.
6.2 ASSISTANCE BY OWNER. The Licensor and Owner shall be responsible
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for reasonably assisting Holmedco in the Development of the Products and
securing financing. Holmedco shall pay the reasonable out of pocket
expenses thereof. After Holmedco obtains seed financing of at least
$10,000,000 U.S., Holmedco shall pay Owner for such services at the rate of
$15,000 US per month, such payments to be retroactively paid for services
commencing June 1, 1994 through FDA Phase II approval for marketing.
6.3 CLINICAL AND PRECLINICAL STUDIES. Holmedco shall have the right
--------------------------------
to conduct clinical and preclinical studies at its cost and expense in
support of human anti-viral indications for and formulations of the
Products.
7. REGULATORY AFFAIRS
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7.1 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 top-choice
consultant as soon as possible.
7.2 LICENSOR AND OWNER SUPPORT OF REGULATING ACTIVITIES. Licensor and
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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.
7.3 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 IND and NDA
approvals on the Products. Owner and Xxxxxxxxx will get full credit in all
publications for the invention, and will be kept fully involved in the
development, of any Product.
7.4 REPORTING OF ADVERSE REACTIONS. Holmedco and Licensor shall
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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.
8. INTELLECTUAL PROPERTY
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8.1 OWNERSHIP. Owner shall have and retain ownership of and title to
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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 10.3 below in the Know-How, Background Technology and Improvements
(excluding Patent Rights).
8.2 PATENT PROSECUTION FOR EXISTING PATENT RIGHTS. Subject only to
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the assignments between Owner and Xxxxxxxxx, 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 Xxxxxxxxx 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, Xxxxxxxxx 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. Xxxxxxxxx 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
Xxxxxxxxx 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 Xxxxxxxxx. The reasonable expenses of the agents shall
be discharged by the Licensee.
8.3 CERTAIN INTELLECTUAL PROPERTY. Subject to Section 8.1 above,
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Xxxxxxxxx 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.
8.4 THIRD PARTY INFRINGEMENT.
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(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 to support said infringement, suspected infringement
or unauthorized use or misappropriation.
(b) Except as provided in Section 8.4(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 Xxxxxxxxx sufficient advance
notice of its intent to file said suit and the reasons therefore, and shall
provide Xxxxxxxxx with an opportunity to make suggestions and comments
regarding such suit. Holmedco shall keep Xxxxxxxxx promptly informed, and
shall from time to time consult with Xxxxxxxxx regarding the status of any
such suit and shall provide Xxxxxxxxx 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
Xxxxxxxxx such portion of the Infringement Proceeds as Holmedco and
Xxxxxxxxx may agree upon in light of Xxxxxxxxx'x royalty rights under this
Agreement or, if they cannot agree on an amount, such amount as determined
by the arbitrator under Section 12 below. If necessary, Xxxxxxxxx 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. Xxxxxxxxx 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 Xxxxxxxxx personnel, incurred in rendering such assistance.
Xxxxxxxxx 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 Xxxxxxxxx without obtaining the prior
written consent of Xxxxxxxxx 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 Xxxxxxxxx of its intent not to initiate such
suit, and Xxxxxxxxx shall have the right, at the expense of Xxxxxxxxx, 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), Xxxxxxxxx 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, Xxxxxxxxx shall remit to Holmedco such portion of the Infringement
Proceeds as Holmedco and Xxxxxxxxx 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 12
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
Xxxxxxxxx'x request, Holmedco shall offer reasonable assistance to
Xxxxxxxxx in connection therewith at no charge to Xxxxxxxxx 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.
9. EXCHANGE AND USE OF DATA
------------------------
9.1 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 US. 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.
9.2 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.
9.3 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.
9.4 PUBLICATIONS. No Party shall submit for written or oral
------------
publication any proprietary data or other proprietary information in
violation of Section 9.5 below. To ensure compliance with the provisions of
this Section 9.4, 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 contracts 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.
9.5 CONFIDENTIAL INFORMATION. During the term of this Agreement and
------------------------
for two (2) 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 9.5) 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 10.3 below.
10. TERM AND TERMINATION
--------------------
10.1 TERM. This Agreement shall remain in effect, unless sooner
-----
terminated as set forth in Section 10.2 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.
10.2 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 Xxxxxxxxx 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 Xxxxxxxxx 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 Xxxxxxxxx as a result of
Holmedco's inability to meet the conditions under Section 3.1 or this
Agreement.
10.3 RIGHTS AND DUTIES UPON TERMINATION. The following Sections shall
-----------------------------------
survive termination of this Agreement: Sections 5, 8.1, 8.3, 10.3, 11, 12,
and 14.1 through 14.10, inclusive. Further, upon termination of this
Agreement by Xxxxxxxxx or Owner pursuant to Sections 10.2(b) or 10.2(c) or
Section 13 below, Holmedco shall return to each of Xxxxxxxxx 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 in
accordance with its term as provided in Section 10.1, Holmedco is hereby
granted a non-exclusive perpetual license to use the Know-How, Background
Technology and Improvements (excluding Patent Rights).
11. INDEMNIFICATION
---------------
11.1 BREACH OF REPRESENTATION. WARRANTY OR COVENANT: ACTS AND
--------------------------------------------------------
OMISSIONS; INFRINGEMENT. Xxxxxxxxx and Owner shall indemnify
------------------------
Holmedco and its Affiliates and Holmedco shall indemnify Xxxxxxxxx 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, Xxxxxxxxx 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 11.1 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 11.1 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
10.2(c) after expiration of the applicable cure period.
11.2 THIRD PARTY CLAIMS. Upon receiving notice of any claim or suit
------------------
under Section 11 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, Xxxxxxxxx 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.
11.3 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.
12. 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 Xxxxxxxxx, 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.
13. 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 be 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.
14. MISCELLANEOUS
-------------
14.1 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 thirty (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.
14.2 WAIVER. The failure of any Party hereto at any time to require
------
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.
14.3 GOVERNING LAW. This Agreement shall be governed by and construed
-------------
in accordance with the laws of the State of Washington, U.S.A.
14.4 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.
14.5 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.
14.6 EFFECTIVENESS. This Agreement shall become effective immediately
-------------
upon execution and delivery by the Parties.
14.7 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.
14.8 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 Xxxxxxxxx is acquired by merger, asset
acquisition or stock acquisition, Xxxxxxxxx shall take all steps necessary
to ensure the acquirer assumes the obligations of Xxxxxxxxx under the
license agreement.
14.9 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.
14.10 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 Xxxxxxxxx: Xxxxxxxxx, 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.
14.11 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.
14.12 NON-LIABILITY OF PROMOTER. Owner and Licensor acknowledge
-------------------------
and agree that Xxxxxxx X. Xxxxxx is a promoter of Holmedco and that they
will only look to Holmedco, once formed and organized as a corporation, for
performance of any obligation under this Agreement including, without
limitation, the indemnification provisions of Section 11.
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 XXXXXXXXX LIMITED
CORPORATION
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxxxxxx
----------------------------- ---------------------------
Its: Chairman & CEO Its: Chairman & Managing Director
----------------------------- ------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
----------------------------------
XXXXXXX X. XXXXXXXXXXX
AMENDMENT NO. 1 TO
LICENSE AGREEMENT
This Amendment is made as of this 5th day of February 1995, by
and between XXXXXXXXX LIMITED, a Delaware corporation ("Xxxxxxxxx" 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 May 18, 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. 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. Two Hundred Fifty Thousand
Dollars ($250,000) due on February 15, 1995 and payable
no later than February 28, 1995. "
2. Section 6.2 is hereby deleted and replaced with the following
Section 6.2:
"6.2 ASSISTANCE BY OWNER. The Licensor and Owner shall
-------------------
be responsible for reasonably assisting in the
Development of the Products and securing financing.
Xxxxxx-Xxxx shall pay the reasonable out of pocket
expenses thereof. After Xxxxxx-Xxxx obtains seed
financing of at least U.S. $10,000,000 in the
aggregate, Xxxxxx-Xxxx shall pay Owner for such
services at a rate of U.S. $15,000 per month (the
"Monthly Compensation"), such payments to be
retroactively paid for such services commencing June 1,
1994 through the completion of FDA Phase II; provided,
the aggregate Monthly Compensation to be paid Owner
under this Section 6.2 shall not exceed U.S. $250,000.
In the event Xxxxxx-Xxxx has not obtained seed
financing of U.S. $10,000,000 in the aggregate by
December 31, 1995, then, on such date, Xxxxxx-Xxxx
shall pay Owner the maximum amount payable to Owner
under this Section 6.2 less any amounts, if any, paid
to Owner prior to December 31, 1995."
3. The following sentence is hereby added to the end of Section 3.5:
"If Xxxxxx-Xxxx fails to make the annual renewable
license fee for any given year, Xxxxxxxxx'x exclusive
remedy, provided Xxxxxxxxx has provided written notice
to Xxxxxx-Xxxx and allowed Xxxxxx-Xxxx thirty days to
cure such failure, shall be (i) to terminate this
Agreement and (ii) to license such rights to a third
party at Xxxxxxxxx'x discretion. "
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" "Xxxxxxxxx" or "Licensor"
XXXXXX-XXXX, INC. XXXXXXXXX LIMITED
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 XXXXXXXXX LIMITED, a Delaware corporation ("Xxxxxxxxx" 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 May 18, 1994, as amended by that certain
Amendment No.l 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. 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.
2. 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. Two Hundred Fifty Thousand
Dollars ($250,000), payable on or before March 17,
1995."
3. 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" "Xxxxxxxxx" or "Licensor"
XXXXXX-XXXX, INC. XXXXXXXXX LIMITED
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 XXXXXXXXX LIMITED, a Delaware corporation
("Xxxxxxxxx" 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 May 18, 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 Licensor's account 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. Two Hundred Fifty Thousand
dollars (250,000) payable as follows: U.S. $125,000 is
payable on or before March 27th, 1995 and the remaining
U.S. $125,000 is due and payable from funds realized
per Section 3 of this Amendment."
3. As of March 28th, 1995, fifteen percent (15%) of all funds or
investments acquired by or expended, on behalf of, Xxxxxx-Xxxx, Inc.
by way of equity sale, loan or other means, but excluding the funds
outlined in the following sentence, to be transmitted in payment of
the Licensing fees outstanding per Section 2 of this Amendment
together with the fees due per Section 2 of Amendment No. 3 to the
Edenland Inc. License Agreement to Licensor's account within ten days
of the beneficial receipt of such funding by Xxxxxx-Xxxx, Inc. but no
later than April 28th, 1996. However, without prejudice to the
preceding sentence funding to a maximum of $1,000,000 may be raised in
the interim by Xxxxxx-Xxxx, Inc. prior to the payment of the
outstanding Licensing fees due per the Xxxxxxxxx Licensing Agreement
and the Edenland, Inc. Licensing Agreement, provided $500,000 of such
funds are utilized for the sole purpose of performing and servicing
patient clinical trials to verify the clinical efficacy of Inactivin.
Without prejudice to the preceding sentence the final date for payment
of the outstanding Licensing fees of Xxxxxxxxx Licensing Agreement and
the Edenland, Inc. Licensing Agreement is 28th, April, 1996."
4. Xxxxxx-Xxxx shall make any necessary payments, commencing when
working capital is available to Xxxxxx-Xxxx but not later than August
1995, due per clause 8.2 of the Xxxxxxxxx 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.
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" "Xxxxxxxxx" or "Licensor"
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
------------------------------ ------------------------------
Its: CEO Its: Director
----------------------------- -----------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
----------------------------------
XXXXXXX X. XXXXXXXXXXX
AMENDMENT NO. 4 TO
LICENSE AGREEMENT
This Amendment is made to be effective as of the 17th day of
March 1995, by and between XXXXXXXXX LIMITED, a Delaware corporation
("Xxxxxxxxx" 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 May 18, 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 and
Amendment No. 3 dated 17th March 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 per Amendment No. 3 dated 17th March 1995, be
transmitted to Licensor's account 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. Section 6.2 is deleted in its entirety.
3. 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.
AMENDMENT NO. 4 TO
LICENSE 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" "Xxxxxxxxx" 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 3
AMENDMENT NO. 5 TO
LICENSE AGREEMENT
This Amendment is made to be effective as of the day of August, l
995, by and between XXXXXXXXX LIMITED, a Delaware corporation ("Xxxxxxxxx"
and/or "Licensor"), EDENLAND INC, a Delaware corporation ("Edenland" and/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 May 18, 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,
Amendment No. 3 dated 17th March, 1995 and Amendment No. 4 dated 17th,
March, 1995 (as amended, the "Xxxxxxxxx Agreement") and
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 and
Amendment No. 3 dated 17th, March, 1995 (as amended, the "Edenland
Agreement") and
WHEREAS, Xxxxxxxxx, Edenland, Xxxxxxx X. Xxxxxxxxxxx and
Xxxxxx-Xxxx desire to amend the above cited Agreements in the manner set
forth herein in order to facilitate a unification and strengthening of the
asset base or Xxxxxx-Xxxx in order that a certain Private Placement
Memorandum which is to be published within the month of August 1995 may
reflect a more beneficial commercial potential to fixture investors.
NOW, THEREFORE, in consideration of the premises, the provisions
and the respective agreements hereinafter set forth, the parties to each of
the individual agreements outlined above, that is the Xxxxxxxxx Agreement,
the Edenland Agreement hereby jointly and severally agree as follows:
1. It is the understanding of all parties to this Amendment, which
is to be considered a joint amendment to each of the above cited
Agreements, that a Private Offering Memorandum, which offers for sale
certain securities ("OFFER") by Xxxxxx-Xxxx Inc., a party to all the
above Agreements, in order to raise a minimum of $2,500,000 U.S. will
be published within 60 days of this Amendment and that the closing of
the said OFFER will occur prior to the 1st, April, 1996.
2. The payments due per Section 3.1 of the Xxxxxxxxx Agreement, that
is per Items 2 and 3 of Amendment No. 3 dated 17th, March, 1995 to the
Xxxxxxxxx Agreement and the payments due per the Edenland Agreement,
that is per Item 2 of Amendment No. 3 to the Edenland Agreement are
hereby amended and combined and replaced with the following schedule
of payments:
Page 2 of 3
Section 3.1 of the Xxxxxxxxx Agreement is hereby deleted in its
entirety and is replaced with the following:
"Within seven (7) days of the closing of the said OFFER a
Licensing Fee of U.S. Three Hundred and Fifty Thousand Dollars
(350,000) shall be payable as directed by Xxxxxxx X. Xxxxxxxxxxx
to either Xxxxxxxxx Inc. or Edenland Inc. This payment shall
satisfy all the terms of payment due per sections 2.2 of the
Xxxxxxxxx Agreement and 2 of the Edenland Agreement.
Contemporaneously with payment in full of such license fee,
Xxxxxxxxx, Edenland and Owner shall xxxxx Xxxx a first perfected
security interest in the Patent Rights and Know-How to secure
Xxxxxx-Xxxx'x exclusive license hereunder and the obligations of
Xxxxxxxxx, Edenland and owner hereunder and shall execute such
documents as are reasonably necessary and desirable to create and
perfect such security interests. If the OFFER is unsuccessful or
does not take place then the final date for payment of the above
amount shall be 28th, April 1, 996. An additional Licensing Fee,
which shall not be less than U.S. Six Hundred Thousand Dollars
(600,000), shall be payable not later than 24 months from the
payment of the above Three Hundred and Fifty Thousand Dollars
(350,000), by way of a five percent (5%) payment of all net
proceeds or funds or investments acquired by or expended, on
behalf of, Xxxxxx-Xxxx, Inc. by way of equity sale, partnership
agreements, loan or other means within 24 months following the
payment of the above Three Hundred and Fifty Thousand Licensing
Fee, such percentage shall not apply to any funds raised in this
initial OFFER of Xxxxxx-Xxxx. After the above sum of Six Hundred
Thousand Dollars (600,000) has been paid the said 5% shall be
reduced to 2.5% for the remaining time period of the allowed 24
months. Funds payable per Clause 3.3 of the Xxxxxxxxx License
Agreement and 3.3 of the Edenland Agreement shall not be
considered payments towards this Licensing Fee of U.S. Six
Hundred Thousand dollars (600,000) which must be paid from funds
raised by the (Company."
3. Except as specifically set forth herein, the Agreement shall
remain unaffected and shall remain in fill force and effect. This
Amendment shall be deemed part of, and consumed in accordance
with, the Agreement.
Page 3 of 3
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" "Xxxxxxxxx" or "Licensor"
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
------------------------------- -------------------------------
Its: CEO Its: Director
------------------------------ ------------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
------------------------------------
XXXXXXX X. XXXXXXXXXXX
Amendment No. 6
Page 1 of 3
AMENDMENT NO. 6 TO
LICENSE AGREEMENT
This Agreement is made to be effective as of the 31st day of
October, 1996, by and between XXXXXXXXX LIMITED, a Delaware corporation
("Xxxxxxxxx" and/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 May 18, 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, Amendment No.
3 dated 17th, March, 1995, Amendment No. 4 dated 17th, March, 1995 and
Amendment No. 5 dated 25th, August, 1995 (as amended, the "Xxxxxxxxx
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 agreement hereinafter set forth, the parties hereby agree as
follows:
A. In consideration for the changes to the Xxxxxxxxx and Research,
Development, and Option Agreements, Xxxxxx-Xxxx agrees to pay an
additional licensing fee to Owner of $10,000 per month beginning
on November 5th, 1996 and on the fifth day of each month
thereafter until the Effective date of the Merger or May 5th,
1997.
All advances to date will be deducted from the final license fees
owed per amendment No. 5, Section 3.1.
B. Section 3.5 of the Agreement is hereby amended in its entirety as
follows upon the understanding that Xxxxxx-Xxxx closes its
proposed merger with Initial Capital acquisition Corporation, a
Delaware corporation on or before May 15th, 1997. If the Initial
Acquisition Corporation Merger with Xxxxxx-Xxxx does not occur on
or before May 15th, 1997 then this Amendment No. 6 shall become
null and void and the present Agreement, as amended by Amendments
Xx. 0, Xx. 0, Xx. 0, Xx. 0 and No. 5 only, prior to this within
Amendment, shall be the full and true Agreement between the
parties.
Amendment No. 6
Page 2 of 3
3.5 CONTINGENT MINIMUM ROYALTY. A renewable annual license fee of
--------------------------
US$500,000 shall be payable, as outlined herein. This fee amount
is deductible from royalty payments, due as per Section 3.2,
which become payable in the 12-month period following renewal of
license. Xxxxxx-Xxxx may deduct from this annual fee an amount
equal to any payments made under Section 3.3 above. Xxxxxx-
Xxxx'x payment obligation under this Section 3.5 shall become due
and payable within 30 days from the Effective Date of the
occurrence of one, or any, of the following events;
(a) Xxxxxx-Xxxx raises $18,000,000 in the aggregate from Capital
Funding Events, as defined herein occurring after May 18th, 1994;
or
(b) Xxxxxx-Xxxx sub-licenses either in full or any part thereof, of
the technology received pursuant to, or developed from, the
Xxxxxxxxx License Agreement provided that funds received by
Licensor from the sub-licensing arrangement shall be applied
toward the minimum royalty amount in the year in which such funds
are received by Licensor; or
(c) Xxxxxx-Xxxx generates or commences sales or marketing of any
product; or
(d) Xxxxxx-Xxxx licenses or funds research of any technology not
developed or based upon its Licensed technology pursuant to its
Agreements with Edenland, Inc., Xxxxxxxxx and/or Xxxxxxx X.
Xxxxxxxxxxx; or
(e) If none of the events described in (a), (b), (c) or (d) occur
prior to the 10th, February, 1999 then that date, 10th, February,
1999, shall be the Effective Date.
The minimum annual renewal fee of US$500,000 shall commence and be
payable within 30 days of the Effective Date as defined above and
shall become due and payable each anniversary of the initial Effective
Date. Xxxxxx-Xxxx can elect to pay the said minimum annual renewable
fee by way of cash or a cash value in Xxxxxx-Xxxx Stock, valued at the
price quoted for the stock at the Effective Date as defined above.
The term "Capital Funding Events" shall mean all funds received, after
May 18th, 1994, by Xxxxxx-Xxxx, from sale of stock or equity,
sublicense, partnership or joint venture agreements, loans, private
placements, the exercise of warrants or stock options, or other
similar transactions.
If Xxxxxx-Xxxx fails to make the annual renewable license fee for any
given year, Xxxxxxxxx'x exclusive remedy, provided Xxxxxxxxx has
provided written notice to Xxxxxx-Xxxx and allowed Xxxxxx-Xxxx thirty
days to cure such failure, shall be (i) to terminate this Agreement
and (ii) to license such rights to a third party at Xxxxxxxxx'x
discretion.
C. 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.
Amendment No. 6
Page 3 of 3
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" "Xxxxxxxxx" or "Licenser"
XXXXXX-XXXX, INC. XXXXXXXXX LIMITED
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Xxx Xxxxxxxxxxx
---------------------------- ----------------------------
Its: Chairman/CEO Its: Director
--------------------------- ---------------------------
Date: 1st Nov. 96 Date: 1st Nov. 96
-------------------------- --------------------------
"Owner"
/s/ Xxxxxxx X. Xxxxxxxxxxx
--------------------------------
XXXXXXX X. XXXXXXXXXXX
Date: 1st Nov. 1996
---------------------------
