TECHNOLOGY LICENSE
AGREEMENT
This Technology License Agreement (the
“Agreement”) dated as of March 16, 2005 is entered into
by and between Nostrum Pharmaceuticals, Inc., a Delaware
corporation (“Nostrum”), and Bionutrics, Inc., a Nevada
corporation (“Bionutrics”), and replaces in its
entirety that certain Product Development and License Agreement
dated as of June 16, 2004, as amended, previously entered into by
the parties.
WHEREAS,
Nostrum has developed, and is in the process of developing, certain
controlled release and other formulation technology for
pharmaceutical products;
WHEREAS, Bionutrics is researching, developing,
manufacturing, marketing and selling pharmaceutical products;
and
WHEREAS,
Bionutrics desires to license from Nostrum the exclusive right to
employ Nostrum’s technology to research, develop,
manufacture, market, sell and otherwise commercialize certain
pharmaceutical products, and Nostrum desires to grant such license
to Bionutrics, all on the terms and conditions hereinafter set
forth;
NOW, THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereby agree, as follows:
Article 1 -
Definitions
The capitalized terms set forth below shall for
the purposes of this Agreement have the meanings ascribed as
follows.
“Affiliate” means any Person which
controls, is controlled by or is under common control with a party.
The term “control” means the ownership, directly or
indirectly, of more than fifty percent (50%) of the voting stock or
equity interest of a Person, or the right to receive over fifty
percent (50%) of the profits or earnings of a Person or any other
relationship which in fact conveys the power to control the
management, business and affairs of a Person.
“Effective Date” means March 16,
2005.
“FDA” means the United States Food
and Drug Administration or any successor agency of the United
States government.
“Formulation” means the design,
creation, and production of a specific pharmaceutical composition
defined by dosage, method of release, strength and attendant
pharmacokinetics which uses the Nostrum Technology and includes a
Target Active Agent together with other components that, in the
case of 505(b)(2) Products, produces unique functionality in the
taste, solubility, absorption, food-effect or other attributes that
modify the Target Active Agent’s pharmacokinetics or
side-effects, and, in the case of Generic Products, achieves
bioequivalence with the Target Active Agent.
“Functional Nutrition Products”
shall have the meaning set forth in Section 2.3(b).
“Gross Profit”, for any Product,
means, with respect to any period, Net Sales for the Product in
that period less Bionutrics’ cost of goods sold for the
Product, calculated in accordance with generally accepted
accounting principles. For purposes of this Agreement, the term
“cost of goods sold” shall mean, as applicable, (i) the
purchase price paid by Bionutrics to the third party manufacturer
of the Product plus the costs of shipment paid by Bionutrics that
are associated therewith, or (ii) the fully allocated cost-of-goods
of the Product if manufactured by Bionutrics or an Affiliate of
Bionutrics, as calculated in accordance with generally accepted
accounting principles; provided, however, that no amount for
selling or marketing expenses shall be included and that amounts
for general or administrative expenses or costs of working capital
shall be included only to the extent that those amounts are
directly attributable to the manufacture of the Product based upon
the actual use of the manufacturing facilities by Bionutrics or an
Affiliate of Bionutrics for that purpose. Notwithstanding any
provision herein to the contrary, any amounts accounted for in the
calculation of Net Sales shall not also be included in determining
the cost of goods sold.
“Litigation Expenses” means
out-of-pocket costs and expenses incurred by Bionutrics (i) in
connection with the defense of any claim, suit or other legal
action alleging that a Generic Product being developed, marketed
and/or sold by Bionutrics hereunder infringes upon or
misappropriates a third party’s patent or other intellectual
property right, or (ii) in connection with the resolution of any
such claim, suit or other legal action, including any judgments or
awards against Bionutrics or any Affiliate of Bionutrics or
subcontractor and any amounts paid in settlement (including license
fees and royalties).
“Net Sales”, for any Product, means,
with respect to any period, the amounts actually received by
Bionutrics or its Affiliates from unaffiliated third parties
(whether an end-user, distributor or otherwise) for the sale of the
Product in the Territory, and exclusive of inter-company transfers
or sales between or among Bionutrics and its Affiliates, less the
following reasonable and customary deductions (without duplication)
from such gross amounts:
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normal and
customary trade, cash and quantity discounts, allowances and
credits;
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credits or
allowances actually granted for damaged goods, returns or
rejections of Product and retroactive price reductions;
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sales or
similar taxes (including duties or other governmental charges
levied on, absorbed or otherwise imposed on the sale of the Product
including, without limitation, value added taxes or other
governmental charges otherwise measured by the billing amount, when
included in billing);
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all charge back
payments, discounts and rebates (whether mandated or otherwise)
granted to managed health care organizations or to federal, state
and local governments, their agencies, and purchasers and
reimbursers or to trade customers, including but not limited to,
wholesalers and chain and pharmacy buying groups and charge back
payments, discounts and rebates (whether mandated or otherwise)
charged by national or local government;
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commissions
paid to third parties and sales agents other than Bionutrics’
sales personnel and sales representatives; and
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freight,
postage, shipping, customs duties and insurance charges, when
included in billing.
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“Nostrum Technology” means all of
Nostrum’s proprietary information, know-how, materials and
technology related to the Products (including without limitation,
manufacturing information) and any related patent applications or
patents owned or controlled by Nostrum or its Affiliates to the
extent they cover the Products or any such information, trade
secrets, know-how, materials or technology as applied to the
Products.
“Person” means any natural person,
corporation, unincorporated organization, partnership, association,
joint stock company, joint venture, limited liability company,
trust or government, or any agency or political subdivision of any
government, or any other entity.
“Pivotal Study” means, as applied to
a Generic Product, the pivotal pharmacokinetic biostudy or
biostudies conducted by a fully licensed biostudy facility mutually
satisfactory to Bionutrics and Nostrum which is reasonably expected
to demonstrate, to the satisfaction of the FDA, the intended AB
rated bio-equivalence of the Generic Product with the Target Active
Agent sufficient to enable Bionutrics to submit to the FDA an
acceptable ANDA for the manufacture and commercial sale of the
Generic Product.
“Prestudy” means a pharmacokinetic
biostudy which is intended to indicate the likelihood of
demonstrating bio-equivalence of a Formulation with the Target
Active Agent, typically carried out in a smaller number of
volunteers than those required by FDA for pivotal pharmacokinetic
biostudies.
“Product” means any 505(b)(2)
Product (as defined below) or Generic Product (as defined below)
which meets all of the following criteria: During the Three-Year
Period, (i) Bionutrics notifies Nostrum that it has targeted the
product for development and commercialization pursuant to this
Agreement and provides Nostrum with a description of the product
and the requested functionality therefor and (ii) Nostrum informs
Bionutrics in writing within sixty (60) days following receipt of
the notice that Nostrum believes, based on its preliminary study of
the proposed product, that it has the ability, using the Nostrum
Technology, to formulate the product with the functionality
requested by Bionutrics and that nothing has come to
Nostrum’s attention that makes Nostrum believe that the
product or the Nostrum Technology as applied to the product would
infringe any third party patents, patent applications or other
intellectual property rights.
“505(b)(2) Products” means certain
brandable pharmaceutical products that qualify for filing with the
FDA under a “505(b)(2)” application, or a New Drug
Application (“NDA”), pursuant to the federal Food, Drug
and Cosmetic Act (the “Act”), using Formulations of
Target Active Agents that are defined specifically by dosage,
method of release, strength and the attendant pharmacokinetic
effect resulting therefrom.
“Generic
Products” means certain pharmaceutical products that are AB
rated, generic bio-equivalents of branded products which qualify
for filing with the FDA pursuant to an Abbreviated New Drug
Application (“ANDA”) under the Act, using Formulations
of Target Active Agents that are defined specifically by dosage,
method of release, strength and the attendant pharmacokinetic
effect resulting therefrom.
“Target Active Agent” means a
specific pharmaceutical compound, which has been approved by the
FDA as a branded drug for manufacture and sale to the public for
one or more specific disease indications, which Bionutrics targets
for development as a 505(b)(2) Product or a Generic
Product.
“Territory” means the
world.
“Three-Year Period” means three
years from the Effective Date.
Article 2 - Grant of
License
2.1 License Grant . (a) Nostrum hereby
grants to Bionutrics, and Bionutrics accepts, an exclusive license
under the Nostrum Technology to develop, make, have made, use,
import, offer for sale, market, sell and otherwise commercialize
Products in the Territory. Subject to the terms of this Agreement,
each Product shall be owned by Bionutrics, and Bionutrics shall
have exclusive rights thereto.
(b) Technology License Grant Limit
. Notwithstanding anything herein to
the contrary, the license grant provided in Section 2.1 shall be
limited to no more than ten (10) 505(b)(2) Products and no more
than ten (10) Generic Products which in all such cases shall have
been designated by the parties as Products (as defined in Article
1) within the Three-Year Period.
2.2 Retained Rights . Subject to the license granted to Bionutrics
hereunder, Nostrum shall remain the sole owner of all Nostrum
Technology, including that which Nostrum shall have furnished to
Bionutrics in connection with the performance of Nostrum’s
obligations pursuant to this Agreement. Nostrum shall retain all
right, title and interest to use or license the Nostrum Technology
in connection with any Product, Formulation or process except for
the Products.
2.3 Development of Other Products
.
(a) Bionutrics shall not have any rights with
respect to any products other than the Products, as determined in
accordance with the terms of Section 2.1.
(b) The parties shall within thirty (30) days of
the date of this Agreement execute a product license agreement for
the development and commercialization of functional foods, medical
foods, dietary supplements and similar non-pharmaceutical products
based on Bionutrics’ compositions employing Nostrum
Technology for product formulation, pursuant to which (i)
Bionutrics and Nostrum shall act in good faith in the selection and
approval of the products for development and commercialization
(“Functional Nutrition Products”); (ii) Nostrum shall
make reasonable efforts to develop these products; and (iii)
Nostrum shall receive no royalties for this license or for the
performance of its product development obligations thereunder.
Subject to Nostrum’s retained rights as the sole owner of any
Nostrum Technology used or transferred in connection with the
product license agreement, Bionutrics shall have exclusive rights
with respect to all such Functional Nutrition Products.
(c) During the Three-Year Period, the parties shall
negotiate in good faith one or more agreements for Formulations
and/or Prestudies with respect to Target Active Agents jointly
selected in good faith by the parties.
2.4 Effectiveness of License . Notwithstanding any other provision of this
Agreement, the license grant provided for in this Article 2 shall
not be effective and binding on either party for any purpose unless
and until (i) all notes and other indebtedness of Bionutrics
convertible into common stock of Bionutrics shall be paid,
discharged or converted into common stock of Bionutrics; (ii)
Bionutrics has no indebtedness that is secured by property of
Bionutrics; (iii) Bionutrics has obtained agreement and signatures
per a Lock-Up Agreement (substantially in the form of Exhibit A
hereto) from Bionutrics’ shareholders constituting a minimum
19,500,000 shares of Bionutrics’ outstanding common stock;
and (iv) Bionutrics has certified in writing to Nostrum that the
events described in clauses (i) through (iii) have
occurred.
Article 3 - Research
Program
3.1 Nostrum’s Obligations
(a) Bionutrics and Nostrum shall confer on a
regular basis regarding the status of Nostrum’s development
of potential 505(b)(2) Products and Generic Products and
Bionutrics’ interest in licensing those Products pursuant to
this Agreement; provided, however, that Nostrum shall have no
obligation to confer with, or disclose information to Bionutrics
regarding any product that Nostrum has licensed, or concerning
which it is negotiating a license with a third party (collectively,
“Exempt Products”).
(b) Pursuant to Bionutrics’ reasonable
request, Nostrum agrees that it will conduct and complete (or will
have conducted and completed, as provided below) Formulations and
Prestudies with respect to Products other than Exempt Products to
establish in vivo performance with respect to those
Products (the sequence of events in each case, a
“Project”). Prior to the commencement of a Project, the
parties shall develop a written Project plan setting forth the
subject matter of the Project and an estimate of the costs and
expenses that would be incurred by Nostrum in connection with the
Project. Nostrum shall have the right, in its sole discretion, to
contract with Enem Nostrum Remedies Pvt. Ltd. (“Enem”)
or any of their respective Affiliates or to use third-party
contractors to conduct Formulations and Prestudies in connection
with the Projects as well as any other work under this Section 3.1.
Nostrum agrees that the services to be provided by Nostrum, Enem,
any of their Affiliates, or a third party shall be provided to
Bionutrics at cost to Nostrum.
(c) With respect to each Project, Nostrum and
Bionutrics shall provide each other with access to all information
and copies of all records relating to the Project and the results
of any related Prestudies.
(d) Nostrum will cooperate with Bionutrics in all
phases of the work to be performed under Section 3.2, including,
without limitation, the scale up, any Pivotal Studies and process
validation.
(e) Within thirty (30) days of Bionutrics’
receipt of Nostrum’s invoice therefor, Bionutrics shall pay
or reimburse Nostrum for its reasonable costs and expenses incurred
in connection with the performance of the obligations set forth in
this Section together with the costs and expenses that Nostrum may
have incurred in connection with any Project agreed upon by the
parties prior to the Effective Date.
3.2 Bionutrics Obligations .
(a) Bionutrics shall be responsible for all work
preparatory to, and necessary for, the performance of any clinical
studies (including Pivotal Studies for Generic Products) in
connection with Projects initiated by Bionutrics with respect to
any Products. Bionutrics’ obligation to conduct such studies
with respect to any Product shall be contingent upon the
Product’s successful completion of a Prestudy as well as
stability testing and successful manufacture and release of
finished product for use in the clinical studies.
(b) In the event that clinical studies conducted or
arranged by Bionutrics on any Products demonstrate efficacy and
safety in accordance with applicable FDA regulations, Bionutrics in
cooperation with Nostrum shall prepare, submit and prosecute an
application (an NDA or an ANDA, as the case may be), with the FDA.
Bionutrics and Nostrum will each keep the other fully informed with
respect to the development and commercialization of these Products
including the preparation for, and the results of, any clinical
studies and the prosecution of any applications with the FDA. Upon
request by Bionutrics or Nostrum, the other party will provide the
requesting party with copies of all documents and records in its
possession or control relating to these activities. In the case of
Generic Products, Bionutrics shall start the Pivotal Study within
nine (9) months of the completion the respective Prestudy.
Following the completion of a given Generic Product Pivotal Study,
Bionutrics will within six (6) months file an ANDA with the FDA on
that Generic Product. All applications shall be filed in the name
of Bionutrics, which shall be responsible, at its own expense, for
continuing the post-clinical and stability testing of the Product
necessary for the approval thereof and for obtaining all
governmental approvals for the manufacture and commercial sale of
the Product in the Territory. Bionutrics will have full and
complete ownership thereof.
(c) Bionutrics shall be responsible for all costs
and expenses incurred by it in connection with the performance of
its obligations under this Section. Within thirty (30) days of
Bionutrics’ receipt of Nostrum’s invoice therefor,
Bionutrics shall pay or reimburse Nostrum for all reasonable costs
and expenses which it may incur in providing assistance to
Bionutrics in the performance of its obligations under this
Section.
3.3
Diligence . Following Bionutrics’ receipt of FDA
approval with respect to the manufacture and commercial sale of any
Product in the United States, Bionutrics shall use diligent efforts
to manufacture, market, distribute and sell the Product.
3.4 Excused Performance . All of Bionutrics’ diligence
obligations with respect to the development and commercialization
of a Product under this Agreement are expressly conditioned upon
the continuing absence of any adverse condition or event relating
to the safety or efficacy of the Product, or lack of regulatory
approval, which warrants a delay in the commercialization of the
Product.
3.5 Ownership of Results . Subject to the provisions of Section 9.6, all
data and results obtained or generated by or on behalf of either
Nostrum or Bionutrics in the performance of any Prestudy, Pivotal
Study or other development activities related to the Products to be
performed pursuant to this Agreement shall be the sole property of
Bionutrics and shall be treated as Bionutrics’ Confidential
Information pursuant to Article 5 of this Agreement. Nostrum will,
at Bionutrics’ expense, undertake, without undue delay, to
provide any and all documents deemed necessary to perfect this
right, on an as-needed, as-requested basis.
3.6 Manufacture/Supply . Bionutrics shall have the right to
manufacture or supply the Products or to have the Products
manufactured and supplied by an Affiliate of Bionutrics; provided
that the cost of goods for Products manufactured by Bionutrics or
such Affiliate is competitive with the cost of goods for the
Product as and if manufactured by a qualified third party
manufacturer. Alternatively, Bionutrics shall have the right to
contract with a suitable third party to manufacture and supply
Bionutrics’ requirements for commercial supplies of the
Products. Upon request Nostrum shall cooperate with Bionutrics in
transferring and implementing the Nostrum Technology and
Formulations related to the manufacture of the Products to the site
Bionutrics chose for the manufacture of the Products in accordance
with FDA guidelines applicable to the proposed transfer. Bionutrics
shall reimburse Nostrum within thirty (30) days of
Bionutrics’ receipt of Nostrum’s invoices for all
reasonable out-of-pocket expenses which Nostrum may incur in
connection with the performance of its obligations pursuant to this
Section.
Article 4 -
Payments
4.1 Stock Payment. In partial consideration for the license and
other rights granted to Bionutrics hereunder, Bionutrics has issued
to Nostrum Six Million (6,000,000) shares of its common stock in
accordance with the provisions of a certain Stock Purchase
Agreement between the parties dated as of June 16, 2004 (the
“First Stock Purchase Agreement”), a copy of which is
attached hereto as Exhibit B. The terms, conditions,
representations and warranties contained in the First Stock
Purchase Agreement are incorporated herein by reference.
4.2 Additional Stock Payment .
(a) In partial consideration for the license and
other rights granted to Bionutrics hereunder, Bionutrics shall
issue to Nostrum an additional Six Million (6,000,000) shares of
its common stock (the “Shares”) in accordance with the
provisions of that certain Stock Purchase Agreement between the
parties dated as of March 16, 2005 (the “Second Stock
Purchase Agreement”), a copy of which is attached hereto as
Exhibit C. The terms, conditions, representations and warranties
contained in the Second Stock Purchase Agreement are incorporated
herein by reference.
(b) In the event that more than fifty percent (50%)
of the Products tested during the Three-Year Period fail Pivotal
Studies or other applicable clinical studies, and Bionutrics
terminates the Projects relating to such Products by reason of such
failure, Nostrum shall be required at the conclusion of the
Three-Year Period to return to Bionutrics thirty-three percent
(33%) of the Shares received pursuant to the Second Stock Purchase
Agreement (adjusted for stock splits, stock dividends,
reclassifications, recapitalizations, combinations and exchanges of
shares) (the “Return Shares”). In the case of
Nostrum’s failure to redeliver the Return Shares pursuant to
this Section 4.2(b), Nostrum hereby authorizes Bionutrics to cancel
the Return Shares. Nostrum hereby irrevocably and unconditionally
(and by way of security for the performance of its obligations
under this Section 4.2(b)) appoints any director of Bionutrics from
time to time (other than a person who is also an officer or
employee of Nostrum) its attorney in fact to execute in its name
and on its behalf all documents, and to do all acts and things
which the attorney shall in his discretion consider necessary or
reasonable to effect the cancellation of the Return
Shares.
4.3 Royalties . Bionutrics agrees to pay to Nostrum royalties
on Net Sales of Generic Products in the Territory equal to fifty
percent (50%) of Gross Profit (“Royalties”). These
Royalties shall not apply to, nor shall Nostrum be entitled to
Royalties on Net Sales of 505(b)(2) Products.
4.4 Manner of Payment . Within thirty (30) days after the first
commercial sale of a Generic Product in the Territory, Bionutrics
shall provide Nostrum with written notice to that effect.
Thereafter, Bionutrics shall furnish to Nostrum within sixty (60)
days following the close of each calendar quarter, a written report
for the calendar quarter showing the Net Sales and Gross Profits
from the sale of each Generic Product sold by Bionutrics and its
Affiliates in the Territory during the calendar quarter and the
Royalties payable under this Agreement for the calendar quarter.
Simultaneously with the submission of the written report,
Bionutrics shall pay to Nostrum, for the account of Bionutrics or
the applicable Affiliate, as the case may be, a sum equal to the
aggregate Royalty due for the calendar quarter calculated in
accordance with this Agreement (reconciled for any previous
overpayments or underpayments). All payments to Nostrum hereunder
shall be made by wire transfer of immediately available funds to
the account designated in writing by Nostrum.
4.5 Recordkeeping/Audits .
(a) Bionutrics and, to the extent applicable its
Affiliates, shall keep complete and accurate records in sufficient
detail to enable the Royalties payable hereunder to be determined.
Upon the written request of Nostrum and not more than twice in each
calendar year, Bionutrics and, to the extent responsible for the
manufacture, sale or distribution of the Generic Products, its
Affiliates, shall permit an independent certified public accounting
firm of nationally recognized standing, which is bound by a
confidentiality agreement in favor of Bionutrics to have access, at
Nostrum’s expense, during normal business hours to those
records of Bionutrics and such Affiliates which may be reasonably
necessary to verify the accuracy of the royalty reports hereunder
for any twelve (12) month period. Nostrum shall provide notice at
least thirty (30) days prior to the date of the intended audit.
Nostrum shall have no right to audit any records with respect to
any twelve (12) month period which ended more than ninth-six (96)
months prior to the date of the request. The accounting firm shall
only disclose to Nostrum the relevant Net Sales, Gross Profits and
cost of goods sold information and whether the royalty reports are
correct or incorrect and the specific details concerning any
discrepancies. No other information shall be shared by the
accounting firm with Nostrum. Nostrum’s audit rights under
this Section shall survive the expiration or termination of this
Agreement for a period of one (1) year.
(b) The cost of each audit conducted under this
Section shall be borne by Nostrum unless an audit correctly
determines that Bionutrics underpaid the Royalties due to Nostrum
hereunder by more than five percent (5% ) during any twelve (12)
month period, in which case Bionutrics shall pay to Nostrum the
deficiency (as Bionutrics is required to do regardless of the
amount thereof or the results, requirement or pendency of any
audit) within fifteen (15) days of the date that a final audit
report is issued, and shall also bear the cost of the audit. In the
event that an audit determines that Bionutrics overpaid the
Royalties due to Nostrum, Nostrum shall refund to Bionutrics the
amount of the overpayment within fifteen (15) days of the date that
a final audit report is issued.
(c) Nostrum shall treat all financial information
subject to review under this Agreement in accordance with the
confidentiality provisions of this Agreement and shall cause its
accounting firm to enter into an acceptable confidentiality
agreement with Bionutrics, obligating it to maintain all such
financial information in confidence pursuant to the confidentiality
agreement.
4.6 Withholding . If at any time, any jurisdiction within the
Territory requires the withholding of income taxes or other taxes
imposed upon payments set forth in this Article, Bionutrics shall
make the withholding payments as required and subtract the
withholding payments from the payments set forth in this Article
or, if applicable, Nostrum will promptly reimburse Bionutrics or
its designee the amount of those payments. Bionutrics shall provide
Nostrum with documentation of the withholding and payment. Any
withholdings paid when due hereunder shall be for the account of
Nostrum and shall not be included in the calculation of Net Sales
or Gross Profits, as applicable. In addition, if any deficiency in
the amount or failure to make any withholding payment is caused, in
whole or in part, by any intentional or negligent action or
inaction on the part of Nostrum, Nostrum shall be liable for any
fine, assessment or penalty imposed by any taxing authority in the
Territory for the deficiency in the amount of the withholding or
the failure to make the withholding payment. If Bionutrics is
required to pay a deficiency, or any fine, assessment or penalty
for any deficiency, Nostrum shall promptly reimburse Bionutrics for
those payments for which Nostrum is liable in accordance with this
Section, which reimbursement shall not be included in the
calculation of Net Sales or Gross Profits.
4.7 Board Representation . In further consideration for the license
granted hereunder, Bionutrics agrees to use its best efforts to
cause the Board of Directors of Bionutrics (i) to be comprised of
at least three (3) members and (ii) to include at least one nominee
of Nostrum; provided that Nostrum and its Affiliates are beneficial
owners as of the record date for the election of directors of a
minimum of two million shares of Bionutrics’ common stock
(adjusted for stock splits, stock dividends, reclassifications,
recapitalizations, combinations and exchanges of
shares).
Article 5 -
Confidentiality .
(a) During the term of this Agreement and for a
period of ten (10) years after its expiration or termination, each
party shall maintain as confidential the Nostrum Technology, any
know-how relating to the Products, and any other proprietary,
technical or business information received from the other party
pursuant to this Agreement (“Confidential Information”)
and shall only use the Confidential Information in furtherance of
this Agreement. Both parties agree that any employees provided or
given access to the other party’s Confidential Information
shall be bound by confidentiality obligations essentially the same
as those set forth herein. The foregoing obligations of
confidentiality and use restrictions shall not apply, however, to
the extent that the Confidential Information:
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was known to
the receiving party, as evidenced by its written records, prior to
receipt from the other party;
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is in the
public domain at time of receipt or subsequently enters the public
domain through no breach of this Agreement by the receiving
party;
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after the date
of receipt from the disclosing party, is received without secrecy
obligations from a third party with a bona fide right to disclose
it without violating any right of the disclosing party;
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is
independently developed by the receiving party without the aid,
application or use of any of the disclosing party’s
Confidential Information (and the independent development can be
properly documented by the receiving party);
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is disclosed to
governmental or other regulatory agencies in order to obtain
patents or to gain approval to conduct clinical trials or to market
the Product pursuant to this Agreement, but the disclosure may be
only to the extent reasonably necessary to obtain the patents or
authorizations;
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is necessary to
be disclosed to agents, consultants, Affiliates and/or other third
parties for the developing, making, using, selling or importing of
Product (or for the third parties to determine their interest in
performing those activities) in accordance with this Agreement on
the condition that those third parties agree to be bound by
confidentiality obligations and use restrictions at least as
restrictive as those contained in this Agreement; or
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is required to
be disclosed by law or court order, provided that notice is
promptly delivered to the disclosing party in order to provide the
disclosing party sufficient opportunity to seek a protective order
or other similar order with respect to the Confidential Information
and the receiving party thereafter discloses only the minimum
information required to be disclosed in order to comply with the
request, whether or not a protective order or other similar order
is obtained by the disclosing party.
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(b) Confidential information disclosed under this
Agreement shall not be deemed to be within the foregoing exceptions
set forth in this Section merely because the Confidential
Information is embraced by more general information in the public
domain or in receiving party’s possession. In addition, any
combination of features shall not be deemed to be within the
foregoing exceptions merely because individual features are in the
public domain or receiving party’s possession, but only if
the combination itself and its principle of operation are in the
public domain or in receiving party’s possession without
having been supplied by disclosing party.
5.2 No Publicity or Disclosure of Agreement
Terms . Neither party may
use the name of the other party or its Affiliates in any publicity
or advertising without the prior written permission of the other
party. Notwithstanding the provisions of this Article, either party
may disclose the terms of this Agreement to the extent necessary to
(a) actual or potential lenders or investors; (b) actual or
potential joint venture or merger partners; (c) the party’s
agents, consultants, Affiliates and/or other third parties
necessary to facilitate an actual or potential loan, investment,
joint venture or merger with those parties; or (d) the
party’s accountants, consultants and attorneys, for other
corporate transactions and business, on a need to know basis.
Bionutrics may also disclose portions of this Agreement in an 8-K
or similar disclosure notice, as deemed necessary in its
counsel’s sole discretion, to meet the public company
reporting requirements of the Securities and Exchange Commission
and applicable federal and state laws, rules and
regulations.
Article 6 -
Patents
6.1 Infringement and Third Party Licenses
.
(a)
In the event that
Bionutrics’, or its Affiliates’ making, having made,
using, offering for sale, selling or importing the Products
infringes or misappropriates, will infringe or misappropriate or is
alleged by a third party to infringe or misappropriate a third
party’s patents or other intellectual property rights, the
party hereto becoming aware of any of the foregoing situations
shall promptly notify the other. The parties shall thereafter
attempt to agree upon a course of action with respect
thereto.
(b)
Bionutrics shall be responsible, at
Bionutrics’ expense, for the defense of any claims, demands,
actions or proceedings arising from allegations that development,
making, having made, using, offering for sale, selling or importing
the Products infringes or misappropriates or will infringe or
misappropriate a third party’s patents or other intellectual
property rights. Upon Bionutrics’ request and expense,
Nostrum shall cooperate with Bionutrics in the defense; provided
that Bionutrics shall promptly reimburse Nostrum for reasonable
out-of-pocket costs and expenses incurred by Nostrum in providing
that cooperation.
(c)
Notwithstanding anything to the
contrary in this Agreement, Bionutrics shall be entitled to offset
against any royalties due Nostrum hereunder (but only to the extent
of reducing the royalties due Nostrum by up to fifty percent (50%)
in any calendar quarter) fifty percent (50%) of any Litigation
Expenses which Bionutrics may have incurred through the close of
the calendar quarter for which royalties are then
payable.
6.2 Infringement of Nostrum’s Intellectual
Property Rights by a Third Party .
(a)
Bionutrics and Nostrum shall
promptly notify each other of any infringement of the patent rights
included in the Nostrum Technology as applied to the Products,
and/or any misappropriation or unauthorized use of any of the
Nostrum Technology as applied to the Products, in the Territory
which may come to their attention. Bionutrics shall have three (3)
months to undertake reasonable efforts to obtain a discontinuance
of the aforesaid infringement or unauthorized use of the patent
rights and the Nostrum Technology as applied to the Products, and,
if not successful, Bionutrics shall have the option, but is not
required, to bring suit, at Bionutrics’ expense, against the
infringer or unauthorized user. Nostrum may elect to join any suit
initiated by Bionutrics.
(b)
If Bionutrics fails or elects not
to obtain a discontinuance of the infringement or unauthorized use
and elects not to bring suit against the third party, then in that
event Bionutrics shall give notice in writing to Nostrum of its
election not to bring suit, within thirty (30) days following that
election, and of the circumstances of the infringement or
unauthorized use, including the evidence of the infringing
activities and/or misappropriation or unauthorized use. Nostrum
may, but is not required to (i) obtain a discontinuance of the
infringing operation or unauthorized use; or (ii) bring suit
against the third party. Any suit or action by Nostrum under this
Section shall be conducted either in the name of Nostrum, or
jointly in the names of Bionutrics and Nostrum, as may be required
by the laws of the forum. Bionutrics shall, upon request,
reasonably cooperate with Nostrum in the conduct of the suit or
action. Nostrum shall, after reimbursing Bionutrics for Litigation
Expenses, be entitled to retain and keep any damages received
whether by judgment, settlement or otherwise, as a result of the
suit or action.
Article 7 -
Representations and Warranties
7.1 Representations and Warranties by Each
Party . Each of
Bionutrics and Nostrum hereby represents and warrants to the other
party that:
(a) it is a corporation duly organized and validly
existing under the laws of the state or other jurisdiction of
incorporation or formation
(b) the execution, delivery and performance of this
Agreement by such party has been duly authorized by all requisite
corporate action;
(c) it has all requisite power and authority to
execute and deliver this Agreement and to perform its obligations
hereunder;
(d) the execution, delivery and performance by such
party of this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or result in
a breach of any of the terms and provisions of or constitute a
default under (i) a loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or instrument
binding or affecting it or its property; (ii) the provisions of its
charter documents or bylaws; or (iii) any order, writ, injunction
or decree of any court or governmental authority entered against it
or by which any of its property is bound;
(e) except for the governmental and regulatory
approvals required to market the Product in the Territory, the
execution, delivery and performance of this Agreement does not
require the consent, approval or authorization of, or notice,
declaration, filing or registration with, any governmental or
regulatory authority and the execution, delivery or performance of
this Agreement will not violate any applicable law, rule or
regulation;
(f) this Agreement constitutes such party’s
legal, valid and binding obligation enforceable in accordance with
its terms, subject, as to enforcement, to bankruptcy, insolvency,
reorganization and other laws of general applicability relating to
or affecting creditors’ rights and to the availability of
particular remedies under general equity principles; and
(g) it shall comply with all applicable material
laws, rules and regulations relating to the performance of its
obligations relating to the Products under this
Agreement.
7.2 Representations and Warranties of
Nostrum . Nostrum hereby
represents and warrants to Bionutrics that:
(a) it owns all right, title and interest in and to
the Nostrum Technology as applied to the Products, free and clear
of all liens and other charges and encumbrances;
(b) there are no adverse actions, suits or claims
pending against Nostrum or any of its Affiliates in or before any
court or governmental or regulatory authority with respect to the
Products and/or the Nostrum Technology as applied to the Products,
and no such actions, suits or claims have been threatened against
Nostrum or any of its Affiliates;
(c) as of the Effective Date, to the best of
Nostrum’s knowledge, there is no reason ( e.g .,
debarment under the Act) that would prevent Bionutrics from using
data and information supplied by Nostrum, as part of
Bionutrics’ regulatory submissions for the
Product.
7.3 Representations and Warranties of
Bionutrics . Bionutrics
hereby represents and warrants to Nostrum that it will make all
filings required under applicable federal and state laws, rules and
regulations.
7.4 Continuing Representations
. The representations and warranties
of each party contained in Sections 7.1, 7.2 and 7.3 shall survive
the execution of this Agreement.
7.5 No Inconsistent Agreements
. As of the Effective Date, each
party represents to the other party that it has not and will not
during the term of this Agreement, enter into, any oral or written
agreement or arrangement that would be inconsistent with its
obligations under this Agreement.
ARTICLE 8 -
INDEMNIFICATION
8.1 Indemnification by Nostrum
. Nostrum shall, at its sole cost
and expense, defend, indemnify and hold harmless Bionutrics and its
Affiliates, and their respective officers, directors, agents and
employees from and against all claims, liens, demands, damages,
liability, actions, causes of action, losses, judgments, costs and
expenses (including, without limitation, reasonable
attorneys’ fees) (each a “Claim” and collectively
“Claims”) to the extent the Claims arise out of or in
connection with, result from, or are caused by: (i) any breach by
Nostrum of its representations or warranties contained in Sections
7.1 or 7.2 of this Agreement; or (ii) the gross negligence or
willful misconduct of Nostrum in the performance of its obligations
under this Agreement; provided, however, that Nostrum shall have no
liability or indemnification obligations hereunder to the extent a
Claim is caused by the gross negligence or willful misconduct of
Bionutrics, its Affiliates or their respective officers, directors,
agents and employees.
8.2 Indemnification by Bionutrics
. Bionutrics shall, at its sole cost
and expense, defend, indemnify and hold harmless Nostrum and its
Affiliates, and their respective officers, directors, agents and
employees from and against all Claims to the extent the Claims
arise out of or in connection with, result from, or are caused by:
(i) any breach by Bionutrics of its representations or warranties
contained in Section 7.1 or Section 7.3 of this Agreement; (ii) the
gross negligence or willful misconduct of Bionutrics or its
Affiliates in the performance of its or their obligations under
this Agreement; (iii) the marketing, manufacture, use or sale of
the Products in the Territory by or on behalf of Bionutrics or its
Affiliates; or (iv) allegations that the manufacture, use or sale
of the Products in the Territory by or on behalf of Bionutrics or
its Affiliates infringes third party patents; provided, however,
that Bionutrics shall have no liability or indemnification
obligations hereunder to the extent that the Claim is caused by the
gross negligence or willful misconduct of Nostrum, its Affiliates
or their respective officers, directors, agents and
employees.
8.3 Conditions to Indemnification
. The obligations of the
indemnifying party under Articles 8.1 and 8.2 are conditioned upon
the delivery of written notice to the indemnifying party of any
potential Claim promptly after the indemnified party becomes aware
of the potential Claim. The foregoing notwithstanding, the parties
acknowledge and agree that failure of the indemnified party
promptly to notify the indemnifying party of a potential Claim
shall not constitute a waiver of, or result in the loss of, a
party’s right to indemnification under Articles 8.1 or 8.2,
except to the extent that the indemnifying party’s rights,
and/or its ability to defend against a Claim are materially
prejudiced by the failure to notify. The indemnifying party is
hereby authorized to carry out the sole management and defense of
the potential Claim, and shall have the right to assume the defense
of any suit or claim related to the Claim if it has assumed
responsibility for the Claim in writing. However, if in the
reasonable judgment of the indemnified party, the Claim involves an
issue or matter which could have a materially adverse effect on the
business operations or assets of the indemnified party, the
indemnified party may waive its rights to indemnity under this
Agreement and control the defense or settlement thereof. If the
indemnifying party defends the suit or claim, the indemnified party
may participate in (but not control) the defense thereof at its
sole cost and expense.
8.5 Limitation of Liability . With respect to any claim by one party against
the other arising out of the performance or failure of performance
of the other party under this Agreement, the parties expressly
agree that the liability of a party to the other party for the
breach shall be limited under this Agreement or otherwise at law or
equity to compensatory damages only and in no event shall a party
be liable for punitive or exemplary damages. The foregoing
limitation will not prevent a party entitled to indemnification
pursuant to this Agreement from recovering all components of any
judgment or award against a party by an unaffiliated
party.
Article 9 - Term and
Termination
9.1 Term and Expiration . This Agreement shall continue unless and
until terminated as provided herein and otherwise shall continue in
effect for as long as Bionutrics and/or any of its Affiliates are
marketing any Product.
9.2 Rights of Bionutrics to Terminate
. Bionutrics may, upon written
notice, terminate this Agreement with respect to a Product in the
event that (i) Bionutrics reasonably believes that use of any
portion of the Nostrum Technology as applied to the Product
pursuant to the license granted hereunder would infringe any
patent, copyright, trademark or other intellectual property right
of a third party or misappropriate any trade secret of a third
party; or (ii) the Product loses substantially all of its
commercial value for Bionutrics, due to: (1) expected extraordinary
competition or direct competition, or (2) decrease in sales of any
corresponding product in the Territory based on International
Marketing Service data or e
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