TECHNOLOGY LICENSE AGREEMENT
This Technology License Agreement is effective as of November 17, 1999,
by and between Alex, LLC, a New Mexico Limited Liability company, located at
0000 Xxxxxxx X.X., Xxxxxxxxxxx, XX 00000 ("Licensor") and Protalex, Inc. a New
Mexico corporation, located at X.X. Xxx 00000, Xxxxxxxxxxx, XX 00000
("Licensee").
RECITALS
A. Licensor is the owner of the Technology defined below.
B. Licensee desires to license the Technology pursuant to the provisions
of this Agreement.
NOW, THEREFORE, in consideration of the mutual provisions contained herein,
the receipt and sufficiency of which are hereby acknowledged, the parties agree
as follows:
ARTICLE 1
DEFINITIONS
1.1 INTELLECTUAL PROPERTY RIGHTS. The term "Intellectual Property Rights"
means all United States and worldwide trademarks, service marks, trade names,
trade dress, logos, copyrights, rights of authorship, inventions, moral rights,
patents, rights of inventorship, all applications, registrations and renewals in
connection with any of the above, database rights, trade secrets, rights of
publicity, privacy and/or defamation, rights under unfair competition and unfair
trade practices laws, and all other intellectual and industrial property rights
related there.
1.2 PERMITTED PRODUCTS. The term "Permitted Products" means a directly
injectable liquid or solution, pill, caplet, capsule, patch, or other physical
product form determined by Licensee that is derived from or incorporates the
Technology and that is solely used for the therapeutic treatment of rheumatoid
arthritis and other forms of arthritis, and no other diseases or medical or
health related problems.
1.3 PROTOCOLS. The term "Protocols" means a factual description of the
clinical drug study and of the research subjects, site and duration of the
study, exclusion and inclusion criteria for research subjects, source of
research material, purpose and background of the study which supports the
scientific value of the study, the clinical regimen (i.e., drug protocol that
includes drug and placebo administration and dosages, clinical evaluations,
statistical methods and considerations), risks and benefits, alternative
treatments, compensation to subjects, costs to subjects, consent forms,
disclosure of financial interests and other conflicts of interest, and other
related records and materials.
1.4 TECHNOLOGY. The term "Technology" means (a) the use of a specific
protein or its derivatives identified by Licensor and provided to Licensee to
treat rheumatoid arthritis and perhaps other forms of arthritis; and (b) the
submolecule or submolecules of proteins or their derivatives developed and
selected by Licensor to be used for therapeutic purposes.
ARTICLE 2
GRANT OF LICENSE
2.1 LICENSE. Subject to Licensee's performance of all of the
provisions of this Agreement, Licensor hereby grants to Licensee an exclusive,
perpetual, non-transferable, indivisible, worldwide license ("License"),
without the right to sublicense, to use or incorporate the Technology only to
develop Protocols for the Permitted Products, and to use or incorporate the
Technology to design, develop, test, market, sell and distribute the Permitted
Products, and for no other purpose. The parties agree that the exclusive nature
of the License only relates to the Permitted Products; in other words, Licensor
will not license the Technology to another party to develop Permitted
Products; but Licensor has the unilateral right to license the Technology to
other parties in order to treat other diseases and/or to develop any other
products except for the Permitted Products.
2.2 RESTRICTIONS. Notwithstanding the License granted in Section
2.1, Licensee shall not directly or indirectly:
(a) Integrate or incorporate the Technology into any other
products or materials other than Permitted Products and Protocols and/or adapt,
implement or otherwise exploit the Technology to develop, create, produce, sell
or distribute any products or things other than the Permitted Products and
Protocols;
(b) Prepare, develop, make or have made, sell or otherwise
distribute any derivative works based upon the Technology;
(c) Modify, reconstruct, extract, merge, re-analyze or reverse
engineer any potions of the Technology;
(d) Grant any sublicenses or any other subsidiary uses of the
Technology; and/or
(e) Disclose, transfer or otherwise make available the
Technology to any of Licensee's employees who do not have a specific need to
know in order to perform Licensee's obligations under this Agreement, and/or to
any other third party or entity at any time.
2.3 RIGHTS RESERVED. Notwithstanding anything to the contrary
contained herein, all rights not specifically granted in this Agreement to
Licensee shall be reserved and remain always with Licensor.
2.4 DELIVERY OF TECHNOLOGY. Upon executing this Agreement, Licensor
will deliver to Licensee all necessary materials constituting the Technology.
2.5 NO WARRANTY. Licensee agrees that it licenses the Technology
"AS-IS" without any warranty of any kind from Licensor. In light of ongoing
research and development, Licensor specifically does not warrant that the
Technology will successfully or effectively treat, arrest or cure rheumatoid
arthritis or other autoimmune diseases, that the Technology will be useful in
developing Permitted Products, or that the Technology will have any desired
therapeutic efficacy. LICENSOR EXPRESSLY DISCLAIMS ALL WARRANTIES REGARDING
THE TECHNOLOGY AND/OR ANY SERVICES PROVIDED BY LICENSOR TO LICENSEE, WHETHER
EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR BASED ON COURSE OF CONDUCT OR
TRADE CUSTOM OR USAGE.
ARTICLE 3
FINANCIAL ARRANGEMENTS
3.1 LICENSE FEE. In exchange for the License granted herein, Licensee
shall pay to Licensor a non-refundable license fee in the amount of Twenty
Thousand Dollars ($20,000) ("License Fee").
3.2 PAYMENT OF LICENSE FEE. Licensee shall pay the License Fee to
Licensor immediately upon executing this Agreement.
3.3 NO ROYALTIES. Except for the payment of the License Fee to Licensor,
Licensee should not be obligated to pay any royalties or any monies to Licensor
from the sale or other distribution of the Permitted Products.
ARTICLE 4
PROPERTY RIGHTS
4.1 LICENSOR'S RIGHTS. Title to the Technology shall always remain with
Licensor, and Licensee shall not acquire any interest therein except the limited
right to use the same pursuant to this Agreement. The parties agree that
Licensor shall solely own and have exclusive worldwide right, title and interest
in and to the Technology, and to all modifications, enhancements and derivative
works thereof, and in all Intellectual Property Rights related thereto.
Licensee shall not challenge, contest or otherwise impair Licensor's ownership
of the Technology or the validity or enforceability of Licensor's Intellectual
Property Rights related thereto.
4.2 LICENSEE'S RIGHTS. Licensor shall not acquire any interest in the
Permitted Products or the Protocols, except that Licensor shall retain all
rights in the Technology that may be incorporated into the Permitted Products.
As between Licensor and Licensee, Licensee shall solely own and have exclusive
worldwide right, title and interest in and to the Permitted Products and the
Protocols (except the Technology incorporated therein), and to all
modifications, enhancements and derivative works of the Permitted Products and
the Protocols (except as they may relate to the Technology which shall be
retained by Licensor), and in all Intellectual Property Rights related thereto
(except for the Intellectual Property Rights related to the Technology that may
be incorporated into the Permitted Products).
4.3 USE OF LICENSOR'S NAME. Licensee shall not use any trade name,
corporate name, business name, trademark, or service xxxx of Licensor, or any
confusingly similar xxxx or name in connection with the advertising, marketing,
sale, or distribution of the Permitted Products. Licensee agrees that the
granting of the License herein shall not constitute Licensor's approval,
acquiescence, or agreement of Licensee's use of the Technology and/or its
development of the Protocols and the Permitted Products. In addition, Licensee
shall not use Licensor's name in any way with respect to any applications or
other submissions to the Federal Drug Administration ("FDA"), the Center for
Drug Evaluation and Research ("CDER"), the Office of Protection from Research
Risks ("OPRR"), any agency under the purview of the Department of Health and
Human Services ("DHHS"), or any other private or governmental entities without
Licensor's prior written consent.
4.4 CONFIDENTIALITY. Licensee agrees that during the performance of this
Agreement, Licensor may disclose to Licensee confidential information regarding
its business, including without limitation the Technology, other documentation,
know-how, inventions, formulae, designs, research and development activities and
other proprietary information which constitutes trade secrets of Licensor
(collectively "Confidential Information"). Licensee shall not in any way
disclose, copy, modify, distribute or otherwise transfer Licensor's Confidential
Information, or any part thereof, to any other person or entity at any time.
Licensee has the right to disclose the Confidential Information only to its
employees who have a specific need to know in order to perform Licensee's
obligations hereunder, but Licensee shall be responsible for all of its
employees' actions. Licensee shall use Licensor's Confidential Information only
to properly fulfill its obligations hereunder, and not for any other purpose.
Licensor does not represent that the Confidential Information it may disclose
hereunder will meet the requirements of Licensee or that the Confidential
Information when combined with other information or when used in a particular
way by Licensee will be sufficient or suitable for Licensee's purpose. Upon
Licensor's request, Licensee shall immediately return to Licensor the originals
and all copies of any Confidential Information, whether on magnetic media,
written materials or otherwise.
4.5 ENFORCEMENT. Both parties agree that Licensor will be irreparably
harmed and money damages would be inadequate compensation to Licensor in the
event Licensee breaches any provision of this Agreement. Accordingly, all of
the provisions of this Agreement shall be specifically enforceable by injunctive
and other relief against Licensee, in addition to any other remedies available
to Licensor, for Licensee's breach of any provision of this Agreement.
4.6 PROPRIETARY NOTICES. Licensee shall not remove, alter or render
illegible any patent or other proprietary notices of Licensor that are included
in any of the materials regarding the Technology that Licensor provides to
Licensee. Additionally, upon Licensor's request, Licensee shall affix to the
Permitted Products and to the product packaging, labels, containers, advertising
and promotional materials regarding the Permitted Products, any appropriate
patent notices or any proprietary markings specified by Licensor.
4.7 PATENTS. It is anticipated by the parties that Licensor will file one
or more patent applications covering the Technology. At this time, however, the
parties are not aware of whether Licensor will be issued a patent for the use of
the Technology solely to treat arthritis. If Licensor is ultimately issued any
patents that deal exclusively with the use of the Technology for arthritis, then
Licensor agrees to amend this Agreement to grant to Licensee an exclusive
license under such limited patent(s). On the other hand, if Licensor is issued
a patent or patents covering use of the Technology for arthritis and other
diseases or applications, Licensor agrees that it will not enforce any of its
rights under such patents against Licensee provided that Licensee complies with
all of the provisions of this Agreement, and Licensor agrees that it will not
assign such patents to any third party unless such third party similarly agrees
not to enforce any of the rights under such patents against Licensee, provided
that Licensee complies with all of the provisions hereunder.
4.8 INFRINGEMENT. Licensee agrees to notify Licensor of any conduct or
actions on the part of third parties which it deems to be an infringement or
other violation of the Technology. In such event, Licensor shall have the right
to bring an action for infringement or other appropriate action with respect
thereto. Licensor shall exclusively control the prosecution or settlement of
any such action, and shall bring such action in the name of Licensor only or in
the name of both Licensor and Licensee at Licensor's option. Licensee agrees,
at Licensor's expense, to fully cooperate with Licensor in any such action and
provide Licensor with all information and assistance reasonably requested by
Licensor.
ARTICLE 5
ADDITIONAL COVENANTS
5.1 TECHNICAL SUPPORT. Licensor may from time to time provide technical
support or other services to Licensee regarding the use of the Technology,
development of the Protocols or Permitted Products, submissions to the FDA or
other governmental entities, clinical testing and trials, or other matters.
Licensee shall, at its expense, be solely responsible for filing and obtaining
Investigational New Drug (IND) Applications and New Drug Applications ("NDA"),
for conducting clinical trials and testing, and for developing the Protocols and
Permitted Products.
5.2 INSPECTION. Licensee agrees to allow Licensor or its authorized
representatives at reasonable times with reasonable advance notice to enter the
premises of Licensee, or any premise where the Technology is being used, in
order to inspect Licensee's use of the Technology and compliance with all of the
provisions of this Agreement.
5.3 COMPLIANCE WITH LAWS. Licensee agrees that the Technology will be
used and the Protocols and Permitted Products will be developed and produced in
accordance with all applicable laws and regulations and in compliance with any
regulatory or governmental agency that has jurisdiction over such matters.
Licensee also agrees that it will not export or reexport any of the Technology
or Licensor's Confidential Information to any country or territory that is
prohibited from receiving such materials under any applicable laws of the United
States, including without limitation the United States export laws and
regulations. With respect to Licensee's employees to whom it is permitted to
disclose the Technology, Licensee will disclose the Technology only to United
States citizens or persons lawfully admitted for permanent residence so that
such disclosure will not constitute an export.
ARTICLE 6
ALLOCATION OF LIABILITIES
6.1 LICENSOR'S INDEMNITY. Licensor shall indemnify, defend and hold
harmless Licensee, its officers, directors, shareholders, employees, attorneys,
accountants, parent and affiliate entities, agents and representatives against
all damages, claims, liabilities, losses and other expenses, including without
limitation reasonable attorney's fees and costs, whether or not a lawsuit or
other proceeding is filed, that in any way arise out of or relate to (a) any
dispute or claim that the Technology infringes upon or violates any third
party's Intellectual Property Rights under the laws of any country, (b) the
negligent or willful acts or omissions of Licensor, and/or (c) Licensor's breach
of any provision of this Agreement. Licensor shall have exclusive control over
the settlement or defense of such claims or actions; provided, however, if
Licensee determines that there would be a conflict of interest by Licensor's
representation or such representation would otherwise adversely affect Licensee,
Licensee has the right, at its expense, to participate and defend itself in such
actions. Licensee shall give Licensor, at Licensor's expense, all information
and assistance reasonably requested by Licensor to settle or defend such claims
or actions. Licensor shall be entitled to retain all monetary proceeds,
attorney's fees, costs and other rewards it receives as a result of defending or
settling such claims. In the event Licensor fails to promptly indemnify and
defend such claims and/or pay Licensee's expenses, as provided above, Licensee
shall have the right to defend itself, and in that case, Licensor shall
reimburse Licensee for all of its reasonable attorney's fees, costs and damages
incurred in settling or defending such claims within thirty (30) days of each of
Licensee's written requests. This Section 6.1 constitutes Licensor's exclusive
liability for infringement or violation of any third party's Intellectual
Property Rights.
6.2 LICENSEE'S INDEMNITY. Licensee shall indemnify, defend and hold
harmless Licensor, its members, managers, officers, directors, employees,
attorneys, accountants, parent and affiliate entities, agents and
representatives against all damages, claims, liabilities, losses and other
expenses, including without limitation reasonable attorney's fees and costs,
whether or not a lawsuit or other proceeding is filed, that in any way arise out
of or relate to (a) any dispute or claim that the Protocols, Permitted Products
and/or Licensee's use of the Technology infringe upon or violate any third
party's Intellectual Property Rights under the laws of any country, (b) the
development, manufacture, testing, promotion, sale, license or other
distribution of the Permitted Products, (c) Licensee's INDs, NDAs or other
submissions to or actions before the FDA or any other governmental agencies, (d)
Licensee's clinical testing and trials, (e) the negligent or willful acts or
omissions of Licensee, and/or (f) Licensee's breach of any provision of this
Agreement. Licensee shall have exclusive control over the settlement or defense
of such claims or actions; provided, however, if Licensor determines that there
would be a conflict of interest by Licensee's representation or such
representation would otherwise adversely affect Licensor, Licensor has the
right, at its expense, to participate and defend itself in such actions.
Licensor shall give Licensee, at Licensee's expense, all information and
assistance reasonably requested by Licensee to settle or defend such claims or
actions. Licensee shall be entitled to retain all monetary proceeds, attorney's
fees, costs and other rewards it receives as a result of defending or settling
such claims. In the event Licensee fails to promptly indemnify and defend such
claims and/or pay Licensor's expenses, as provided above, Licensor shall have
the right to defend itself, and in that case, Licensee shall reimburse Licensor
for all of its reasonable attorney's fees, costs and damages incurred in
settling or defending such claims within thirty (30) days of each of Licensor's
written requests. This Section 6.2 constitutes Licensee's exclusive liability
for infringement or violation of any third party's Intellectual Property Rights.
6.3 LIMITATION OF LIABILITY. EXCEPT FOR EITHER PARTY'S VIOLATION OF THE
OTHER PARTY'S INTELLECTUAL PROPERTY RIGHTS, AND EXCEPT FOR EACH PARTY'S
INDEMNITY OBLIGATIONS UNDER THIS ARTICLE 6, NEITHER PARTY SHALL BE LIABLE FOR
ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES, WHETHER
FORESEEABLE OR NOT, THAT ARE IN ANY WAY RELATED TO THIS AGREEMENT, THE BREACH
THEREOF, THE USE OR INABILITY TO USE THE TECHNOLOGY, THE RESULTS GENERATED FROM
THE USE OF THE TECHNOLOGY, THE PROTOCOLS OR PERMITTED PRODUCTS, LOSS OF
GOODWILL OR PROFITS, LOST BUSINESS HOWEVER CHARACTERIZED AND/OR FROM ANY OTHER
CAUSE WHATSOEVER. THE PARTIES FURTHER AGREE THAT EACH AND EVERY PROVISION OF
THIS AGREEMENT THAT PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF
WARRANTIES OR EXCLUSION OF DAMAGES IS EXPRESSLY INTENDED TO BE SEVERABLE AND
INDEPENDENT OF ANY OTHER
PROVISION SINCE THOSE PROVISIONS REPRESENT SEPARATE ELEMENTS OF RISK
ALLOCATION BETWEEN THE PARTIES AND SHALL BE SEPARATELY ENFORCED.
ARTICLE 7
TERMINATION
7.1 TERMINATION. Either party shall be entitled to terminate this
Agreement on thirty (30) days' prior written notice to the other party in the
event the other party breaches any of the material obligations on its part to be
performed hereunder and fails to cure such breach within thirty (30) days of
receiving written notice of such breach. In addition, the breach of Sections
2.1, 2.2, 4.1 and 4.2 shall be deemed non-curable and the non-breaching party
then has the right to immediately terminate this Agreement. The provisions of
Sections 2.2, 2.3, 2.5, 4.1, 4.2, 4.3, 4.4, 4.5 Articles 6, 7 and 8 shall
survive the termination of this Agreement.
7.2 CESSATION OF USE. Upon termination of this Agreement: (a) the License
to use the Technology shall automatically revert to Licensor, and Licensee shall
thereafter immediately stop using the Technology in any way; (b) Licensee shall
not further incorporate the Technology in the Permitted Products and/or produce,
sell or distribute the Permitted Products; (c) Licensee shall return to Licensor
all Confidential Information previously disclosed to Licensee; and (d) Licensee
shall remain liable for all of its obligations hereunder that accrued prior to
the date of termination.
7.3 CUMULATIVE REMEDIES. All rights and remedies conferred herein shall
be cumulative and in addition to all of the rights and remedies available to
each party at law, equity or otherwise.
ARTICLE 8
GENERAL PROVISIONS
8.1 RELATIONSHIP OF PARTIES. The relationship between the parties is only
that of a licensor and licensee. Neither party is the agent or legal
representative of the other party, and neither party has the right or authority
to bind the other party in any way. This Agreement creates no relationship as
partners or a joint venture, and creates no pooling arrangement.
8.2 GOVERNING LAW AND VENUE. This Agreement shall be interpreted and
enforced according to the laws of the State of New Mexico, without application
of its conflicts or choice of law rules. This Agreement shall be deemed to be
performed in Albuquerque, New Mexico. Both parties irrevocably submit to the
jurisdiction of the state or federal courts located in Albuquerque, New Mexico
for any action or proceeding regarding this Agreement, and both parties waive
any right to object to the jurisdiction or venue of the courts in Albuquerque,
New Mexico.
8.3 ASSIGNMENT. Licensee acknowledges that the favorable terms of this
Agreement were granted to Licensee only because of Licensee's experience, and
that the substitution of any party by Licensee would destroy the intent of the
parties. Accordingly, Licensee shall have no right to assign, delegate,
transfer or otherwise encumber this Agreement or any portion thereof without
Licensor's prior written consent which can be arbitrarily withheld. In
addition, Licensor shall not transfer, sell or otherwise dispose of the
Technology to a third party unless it concurrently transfers this Agreement and
such third party or transferee agrees to be bound by this Agreement.
8.4 COUNTERPARTS. This Agreement may be executed in several counterparts
that together shall be originals and constitute one and the same instrument.
8.5 WAIVER. The failure of either party to enforce any of its rights
hereunder or at law shall not be deemed a waiver or a continuing waiver of any
of its rights or remedies against the other party, unless such failure or waiver
is in writing.
8.6 SEVERABILITY. If any provision, or part thereof, of this Agreement is
judicially declared invalid, void or unenforceable, each and every other
provision, or part thereof, nevertheless shall continue in full force and
effect, and the unenforceable provision shall be changed or interpreted so as
best to accomplish the objectives and intent of such provision within the limits
of applicable law.
8.7 ATTORNEY'S FEES. In the event a dispute arises regarding this
Agreement, the prevailing party shall be entitled to its reasonable attorney's
fees and expenses incurred in addition to any other relief to which it is
entitled.
8.8 NOTICE. All notices, requests or other communications under this
Agreement shall be in writing, and shall be sent to the parties at their
addresses listed on page 1 above, and shall be deemed to have been duly given on
the date of service if sent by facsimile (provided a hard copy is sent in one of
the manners specified below), or on the day following service if sent by
overnight air courier service with next day delivery with written confirmation
of delivery, or five (5) days after mailing if sent by first class, registered
or certified mail, return receipt requested. Each party is required to notify
the other party in the above manner of any change of address or project manager.
8.9 FURTHER ASSURANCES. Both parties agree to execute such additional
documents and perform such acts as are reasonably necessary to effectuate the
intent of this Agreement.
8.10 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between the parties regarding the subject matter hereof, and supersedes all
prior or contemporaneous understandings or agreements, whether oral or written
regarding the subject matter hereof. This Agreement shall be modified or
amended only by a writing signed by both Licensor and Licensee.
8.11 RECITALS. The parties agree that each and every recital of this
Agreement shall be a covenant and agreement as well as a recital of this
Agreement.
8.12 AUTHORITY. The parties executing this Agreement on behalf of Licensor
and Licensee represent and warrant that they have the authority from their
respective governing bodies to enter into this Agreement and to bind their
respective companies to all the terms and conditions of this Agreement.
8.13 CAPTIONS. The captions of the Articles and Sections in this Agreement
are for convenience only and shall not be used to interpret the provisions of
this Agreement.
8.14 REPRESENTATION. Licensor and Licensee acknowledge that both
parties have requested the law firm of Xxxx, Forward, Xxxxxxxx and Scripps to
represent both of their interests with respect to this License Agreement and
the related transactions between them. Accordingly, each party acknowledges
that as a result of such joint representation, a potential or actual conflict
of interest exists or may arise regarding Xxxx, Forward's representation of
both parties. Each party further acknowledges and agrees that each has been
recommended by Xxxx, Forward to seek the advice of independent counsel
regarding this Agreement and the related transactions between the parties,
and that each party has had more than sufficient opportunity to seek the
advice of such independent counsel. Nevertheless, each party reiterates that
each has specifically requested Xxxx, Forward to represent both of their
interests with respect to this Agreement and the related transactions, and to
continue to represent their respective interests in the future. As a result,
Licensor and Licensee each irrevocably waive any potential or actual conflict
of interest that may arise as a result of Xxxx, Forward's common
representation as discussed above for any and all purposes and for all time.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first written above.
LICENSOR LICENSEE
ALEX, LLC, a New Mexico Limited PROTALEX, INC., a New Mexico
Liability company corporation
By: /s/ Xxxx X. Xxxx By: /s/ Xxxx X. Xxxxxxx
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Name: Xxxx X. Xxxx Name: Xxxx X. Xxxxxxx
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Title: Managing Member Title: President
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