EXHIBIT 10.3
**Note: Confidential Information has been omitted and filed
separately with the Securities and Exchange Commission
CO-DEVELOPMENT AGREEMENT
Dated as of November 21, 2004
By and Between
COGENCO INTERNATIONAL, INC.
a Colorado Corporation
and
DMI BIOSCIENCES, INC.
a Colorado Corporation
CO-DEVELOPMENT AGREEMENT
This Co-Development Agreement ("Agreement"), effective on November 21, 2004
("Effective Date"), is by and between DMI BioSciences, Inc., having a place of
business at 0000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxx
00000-0000 ("DMI") and Cogenco International, Inc., having a place of business
at 0000 Xxxxx Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("COGENCO").
WHEREAS, DMI owns Intellectual Property relating to the use of [**see cover
page note] for the treatment of asthma in humans;
WHEREAS, DMI wants to research, develop and commercialize product(s)
comprising or utilizing a [**see cover page note] for the treatment of asthma in
humans;
WHEREAS, DMI wants to screen [**see cover page note] to select the [**see
cover page note] or [**see cover page note] for the treatment of asthma in
humans;
WHEREAS, COGENCO wants to fund DMI's screening of [**see cover page note]
and DMI's research, development and commercialization of product(s) comprising
or utilizing a [**see cover page note] for the treatment of asthma in humans;
and
WHEREAS, DMI and COGENCO signed a Term Sheet on August 23, 2004, setting
forth certain agreed terms to be included in this Agreement.
NOW THEREFORE, in consideration of the foregoing and the mutual covenants,
terms, conditions and agreements set forth below, the parties agree as follows.
Article 1. Definitions
As used herein, the following capitalized terms have the meanings set forth
below:
1.1 "Affiliate" means any corporation, firm, partnership or other entity
that, directly or indirectly, controls, is controlled by, or is under
common control with, DMI or COGENCO. For the purposes of this
Agreement, "control" or "controlled" means possession of the power to
direct, or cause the direction of, the management and policies of a
corporation, firm, partnership, or other entity, whether through the
ownership of equity, status as a general partner, by contract or
otherwise.
1.2 "Advisory Committee" means the Advisory Committee described in Article
9.
1.3 "Backup Candidate" has the meaning given in Section 3.2.
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1.4 "Calendar Quarter" means each three (3)-month period ending on the
last day of March, June, September and December of a given year.
1.5 "Clinical Trials" means all human clinical trials conducted with a
Product, including Phase 1 through Phase 4 human clinical trials.
1.6 "Clinical Trials Plan" means a Clinical Trials Plan as adopted and
amended from time to time by the Advisory Committee as described in
Article 9. Each Clinical Trials Plan will be a comprehensive plan for
performing all Clinical Trials necessary to obtain Regulatory Approval
of Product(s) in the Territory and will include a budget, a schedule
of deadlines and time periods for accomplishing all necessary
activities, procedures for ensuring compliance with all regulatory and
quality guidelines and requirements, and all other relevant
information.
1.7 "Commercially Reasonable And Diligent Efforts" means, with respect to
research, development and commercialization of a Product, a party's
use of best efforts and resources consistent with the exercise of
prudent scientific and business judgment, as applied to other
pharmaceutical products of similar potential, market size and
competitive environment.
1.8 "Commercialization Plan" means a Commercialization Plan adopted and
amended from time to time by the Advisory Committee as described in
Article 9. Each Commercialization Plan will be a comprehensive plan
for the commercialization of Product(s) in the Territory and will
include a budget, a schedule of deadlines and time periods for
accomplishing all necessary activities (including a deadline for the
First Commercial Sale of Product(s) that have received Regulatory
Approval), marketing plans, descriptions of promotional activities,
sales objectives, branding strategies, and all other relevant
information.
1.9 "Deductible Expenses" for a Product are (i) all of the costs of
manufacturing or purchasing the Product, (ii) all of the costs of
**distributing, shipping and selling the Product, (iii) all of the
costs of marketing, promoting and advertising the Product, (iv)
returns and allowances, (v) all taxes, including income taxes, and
insurance, and (vi) reasonable Overhead. "Deductible Expenses" do not
include the costs of screening, research, development, Preclinical
Studies, Clinical Trials, obtaining Regulatory Approval of the
Product, legal expenses (attorneys fees, filing fees, disbursements,
expert witness fees, etc.), amounts paid as a result of a settlement
or order of court (judgments) in connection with a claim or lawsuit,
or any portion of these costs.
1.10 "[**see cover page note]" means an unsubstituted [**see cover page
note], a substituted [**see cover page note] or a [**see cover page
note] derivative. [**see cover page note] include substituted and
unsubstituted 2,5-[**see cover page note] and derivatives of
2,5-[**see cover page note]. Other names for 2,5-[**see cover page
note] are 2,5-[**see cover page note], [**see cover page note], [**see
cover page note] and [**see cover page note].
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1.11 "DMI" means DMI BioSciences, Inc. DMI is also referred to herein as a
"party". Collectively, DMI and COGENCO are sometimes referred as the
"parties".
1.12 "Drug Approval Application" means an application for Regulatory
Approval required for commercial sales of a Product, such as an NDA.
1.13 "Effective Date" is the date first written above.
1.14 "COGENCO" means Cogenco International, Inc. COGENCO is also referred
to herein as a "party". Collectively, DMI and COGENCO are sometimes
referred as the "parties".
1.15 "FDA" means the United States Food and Drug Administration.
1.16 "Field" means the use of Product(s) to treat asthma in humans.
1.17 "First Commercial Sale" means the first sale of each Product in a
country of the Territory following Regulatory Approval of the Product
in that country, or if no such Regulatory Approval or similar
marketing approval is required, the date upon which each Product is
first commercially available in a country.
1.18 "GCP" means the E6 Guideline for Good Clinical Practice of the ICH.
1.19 "GLP" means the current Good Laboratory Practice regulations
promulgated by the FDA, published at Part 58 of Title 21 of the United
States Code of Federal Regulations, as amended from time to time, and
such equivalent regulations or standards of countries outside the
United States as may be applicable to activities conducted hereunder.
1.20 "GMP" means the current Good Manufacturing Practice regulations
promulgated by the FDA, published at Part 210 et seq. and Parts
600-610 of Title 21 of the United States Code of Federal Regulations,
as amended from time to time, and such equivalent regulations or
standards of countries outside the United States as may be applicable
to activities conducted hereunder.
1.21 "Gross Sales Amount" means all monies and the fair market value of all
other consideration (including payment in kind, exchange or other
form) received with respect to Sales of a Product.
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1.22 "ICH" means International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use.
1.23 "IND" means an Investigational New Drug Application satisfying the
requirements of Part 312 of Title 21 of the United States Code of
Federal Regulations filed with the FDA to commence human clinical
testing of any Product in the United States or any similar filing with
a regulatory authority of another country to commence human clinical
testing of any Product in that country.
1.24 "Indication" means a human disease or condition, an important
manifestation of a human disease or condition, or a symptom associated
with a human disease or condition for which use of a Product is
indicated, as would be identified in the Product's label under
applicable FDA regulations or the foreign equivalent thereof.
1.25 "Indirect Costs" means all of the costs incurred in performing those
activities necessary for specific Preclinical Studies or Clinical
Trial(s) to take place, such as procurement or manufacture of
Product(s), formulation and analytical studies, safety assessments,
and preparation of documentation required by regulatory authorities.
1.26 "Intellectual Property" means: (i) inventions, know-how, trade
secrets, other Proprietary Information, works of authorship, and
trademarks and other designations of origin; (ii) all rights and
privileges therein throughout the world; and (iii) all physical
embodiments thereof.
1.27 "Lead Candidate" has the meaning given in Section 3.2.
1.28 "Major Market Countries" means [**see cover page note].
1.29 "NDA" means a New Drug Application satisfying the requirements of
Title 21 of the United States Code of Federal Regulations filed with
the FDA to obtain Regulatory Approval for a Product in the United
States or any similar filing with a regulatory authority of another
country to market any Product in that country.
1.30 "Overhead" means costs incurred by a party, or for its account, which
are attributable to a party's supervision, services, occupancy costs,
corporate bonus, and its payroll, information systems, human relations
or purchasing functions and which are allocated based on space
occupied, headcount or other activity-based method consistently
applied by the party.
1.31 "Phase 1 Trial" means a human clinical trial in any country that is
conducted to initially evaluate the safety and/or pharmacological
effect of a Product in human subjects or that would otherwise satisfy
the requirements of Part 312 of Title 21 of the United States Code of
Federal Regulations or its foreign equivalent.
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1.32 "Phase 2 Trial" means a human clinical trial in any country that is
conducted to initially evaluate the effectiveness of a Product for a
particular Indication in patients with the Indication or that would
otherwise satisfy the requirements of Part 312 of Title 21 of the
United States Code of Federal Regulations or its foreign equivalent.
1.33 "Phase 2a Trial" means a limited Phase 2 Trial typically conducted in
up to 50 patients to demonstrate the effectiveness of a Product for an
Indication.
1.34 "Phase 2b Trial" means a Phase 2 Trial, the results of which, alone or
in combination with the results of the Phase 2a Trial, would
demonstrate the effectiveness of a Product for a particular Indication
in patients with the Indication or that would otherwise satisfy the
requirements of Part 312 of Title 21 of the United States Code of
Federal Regulations or its foreign equivalent.
1.35 "Phase 3 Trial" means a controlled human clinical trial in any
country, the results of which could be used to establish safety and
efficacy of a Product as a basis for a marketing approval application
submitted to the FDA, or that would otherwise satisfy the requirements
of Part 312 of Title 21 of the United States Code of Federal
Regulations or its foreign equivalent.
1.36 "Phase 4 Trial" means a human clinical trial in any country initiated
after Regulatory Approval in that country within the approved product
labeling.
1.37 "Preclinical Studies" means, with respect to a Product, one or more of
the following: (i) synthesis and formulation; (ii) physical and
chemical properties, (iii) in vitro activity, (iv) in vivo activity in
animals, (v) metabolism, absorption and pharmacokinetics data from
animal studies, (vi) toxicology data, and (vii) similar studies that
are typically performed before first administration of a Product to
humans.
1.38 "Prime Rate" means that prime interest rate specified in the Wall
Street Journal, Colorado Edition, for the date specified.
1.39 "Product(s)" means any pharmaceutical product(s) comprising or
utilizing a Selected Candidate which is(are) used for treatment of
asthma in humans.
1.40 "Profits" means Gross Sales Amount for a Product less all Deductible
Expenses for the Product.
1.41 "Proprietary Information" means all business and technical information
of a confidential and proprietary nature, including ideas, inventions,
discoveries, trade secrets, know-how, protocols, research plans,
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development plans, compilations, methods, techniques, processes, data,
test results, formulas, formulations, computer programs, reports,
other works of authorship, business plans, sales forecasts, marketing
information, pricing and financial information, customer lists,
branding strategy, and planned or pending acquisitions and
divestitures, and all physical embodiments thereof, including disks,
computers, software, printouts, laboratory notebooks, writings, notes,
documentation, records, reports, sketches, plans, memoranda,
compilations, devices, prototypes, instruments, blueprints, diagrams,
specifications, operating instructions, written descriptions,
photographs, videos, chemicals, biological materials, compositions,
lists, invention disclosures, and patent applications.
1.42 "Regulatory Approval" means all approvals, licenses, registrations and
authorizations by the appropriate government entity or entities in a
country or region (such as the European Union) necessary for the
commercial sale of a Product in that country or region, including
where applicable, approval of labeling, pricing, reimbursements and
manufacturing. "Regulatory Approval" in the United States for
Product(s) shall mean final approval of an NDA pursuant to Part 314 of
Title 21 of the United States Code of Federal Regulations permitting
marketing of the Product in interstate commerce of the United States.
"Regulatory Approval" in the European Union for Product(s) shall mean
final approval of a Marketing Authorization Application pursuant
Council Directive 75/319/EEC, as amended, or Council Regulation
2309/93/EEC, as amended.
1.43 "Research And Development Plan" means a Research And Development Plan
as adopted and amended from time to time by the Advisory Committee as
described in Article 9. Each Research And Development Plan will be a
comprehensive plan for the research, development and Preclinical
Studies of Product(s) in the Territory and will include a listing and
prioritization of projects, objectives and goals, a budget, a schedule
of deadlines and time periods for accomplishing all necessary
activities, procedures for ensuring compliance with all regulatory and
quality guidelines and requirements, and all other relevant
information.
1.44 "Revenues" means (i) Profits and (ii) those payments received from
licensees and sublicensees of DMI and/or COGENCO, including licensing
fees, sublicensing fees, milestone payments and royalties.
1.45 "Sales" means sales of each Product in the Territory by either party
to Third Parties in bona fide arms-length transactions.
1.46 "Screening Plan" means a Screening Plan adopted and amended from time
to time by the Advisory Committee as described in Article 9. Each
Screening Plan will be a comprehensive plan for the screening of
[**see cover page note] to select the Selected Candidates for the
treatment of asthma in humans and will include a listing and
prioritization of projects, objectives and goals, a budget, a schedule
of deadlines and time periods for accomplishing all necessary
activities, procedures for ensuring compliance with all regulatory and
quality guidelines and requirements, and all other relevant
information.
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1.47 "Selected Candidates" has the meaning given in Section 3.2.
1.48 "Term Sheet" shall mean that term sheet setting forth certain agreed
terms to be included in this Agreement which was executed by the
parties on August 23, 2004.
1.49 "Territory" means the world.
1.50 "Third Party" means an entity other than DMI or COGENCO. A Third Party
may be an individual, corporation, firm, partnership or other entity.
Third Parties include Affiliates.
1.51 "USA" or "United States" shall mean the United States Of America, its
possessions, territories, and protectorates (including the
Commonwealth of Puerto Rico), and the District Of Columbia.
Article 2. Scope And Goals Of The Development
2.1 It is the intent of DMI and COGENCO to screen [**see cover page note]
and to research, develop, obtain Regulatory Approval for, and
commercialize Product(s) for the Field within the Territory, as more
particularly set forth herein. Therefore, DMI and COGENCO agree,
pursuant and subject to the terms of this Agreement, to cooperate
with, and provide reasonable support for, each other in developing
Product(s), with the goal of obtaining Regulatory Approval for
Product(s) as soon as reasonably practicable for commercial marketing
and sale in the Territory.
2.2 In particular, it is a high priority, and shall be the first priority,
of the parties to develop and commercialize Product(s) for the Field
in the Major Market Countries. Therefore, DMI and COGENCO agree,
pursuant and subject to the terms of this Agreement, to cooperate
with, and provide reasonable support for, each other in developing
Product(s), with the goal of obtaining Regulatory Approval as soon as
reasonably practicable for the commercial marketing and sale of
Product(s) in the Major Market Countries and then in other countries
of the Territory.
2.3 It is also the intent of DMI and COGENCO to share the Revenues
obtained as a result of the commercialization, sales, licensing and
sublicensing of Product(s) for the Field within the Territory.
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Article 3. DMI's Responsibilities
3.1 Subject to the supervision of the Advisory Committee as described in
Article 9, DMI shall be responsible for managing, directing,
supervising and coordinating the screening of [**see cover page note]
and the research, development, Clinical Trials and commercialization
of Product(s) for the Field in the Territory.
3.2 DMI shall be responsible for conducting the screening of the [**see
cover page note] in accordance with the Screening Plan as adopted and
amended from time to time by the Advisory Committee. Based on the
screening results, DMI will select the [**see cover page note] which
shows the most promise for being a successful treatment for asthma in
humans (referred to herein as the "Lead Candidate"). If the screening
identifies more than one [**see cover page note] that would be
suitable for the treatment of asthma in humans, DMI will select a
second [**see cover page note] as a backup compound (referred to
herein as the "Backup Candidate"). The Lead Candidate and the Backup
Candidate are referred to herein collectively as the Selected
Candidates. DMI shall also recommend to the Advisory Committee whether
Product(s) containing the Backup Candidate should be developed for the
Field in conjunction with, or separately from, Product(s) containing
the Lead Candidate, or if development of Product(s) containing the
Backup Candidate should be deferred.
3.3 DMI shall be responsible for conducting research and development for
Products(s) in accordance with the Research And Development Plan for
the Product(s) as adopted and amended from time to time by the
Advisory Committee.
3.4 DMI shall be responsible for conducting all Preclinical Studies for
Products(s) in accordance with the Research And Development Plan for
the Product(s) as adopted and amended from time to time by the
Advisory Committee, and any such Preclinical Studies shall be designed
and conducted so that the results can be used in connection with
efforts to obtain Regulatory Approval of the Product(s) in at least
the Major Market Countries.
3.5 DMI shall be responsible for conducting Phase 1 Trials for Products(s)
in accordance with the Clinical Trials Plan for the Product(s) as
adopted and amended from time to time by the Advisory Committee, and
any such Phase 1 Trials shall be designed and conducted so that the
results can be used in connection with efforts to obtain Regulatory
Approval of the Product(s) in at least the Major Market Countries.
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3.6 DMI shall be responsible for conducting Phase 2 Trials or Phase 2a and
Phase 2b Trials of Product(s). The Phase 2 Trials or Phase 2a and
Phase 2b Trials shall be conducted in accordance with the Clinical
Trials Plan for Product(s) as adopted and amended from time to time by
the Advisory Committee, and the Phase 2 Trials or Phase 2a and Phase
2b Trials shall be designed and conducted so that the results can be
used in connection with efforts to obtain Regulatory Approval of the
Product(s) in at least the Major Market Countries.
3.7 Upon successful completion of Phase 2 Trials or Phase 2a and Phase 2b
Trials, DMI shall be responsible for conducting Phase 3 Trials of
Product(s) and shall be responsible for taking the steps necessary,
and performing the additional work required, to obtain Regulatory
Approval to market Product(s) for the Field in at least the Major
Market Countries in accordance with the Clinical Trials Plan for
Product(s) as adopted and amended from time to time by the Advisory
Committee.
3.8 After Regulatory Approval of Product(s), DMI shall be responsible for
commercializing the Product(s) for the Field in at least the Major
Market Countries in accordance with the Commercialization Plan for the
Product(s) as adopted and amended from time to time by the Advisory
Committee. DMI shall also be responsible for commercializing
Product(s) for which no Regulatory Approval is required in accordance
with the Commercialization Plan for the Product(s) as adopted and
amended from time to time by the Advisory Committee.
3.9 DMI shall be responsible for conducting Phase 4 Trials, if any, for
Product(s) in accordance with the Clinical Trials Plan for the
Product(s) as adopted and amended from time to time by the Advisory
Committee.
3.10 DMI shall be responsible for the manufacture and supply of all
Selected Candidates and all Product(s).
3.11 DMI shall report to Advisory Committee on the status of the screening
of the [**see cover page note] and the research, development, Clinical
Trials and commercialization of the Product(s) in such form, manner
and frequency as the Advisory Committee may request from time to time.
Article 4. COGENCO's Responsibilities
4.1 COGENCO agrees to purchase all of its requirements, if any, of
Selected Candidates and Product(s) from DMI upon commercially
reasonable terms and conditions to be negotiated in good faith by the
parties.
4.2 COGENCO agrees to make the payments provided for in Articles 6 and 7
in a timely manner.
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Article 5. Obligations And Responsibilities Of Both Parties
5.1 Each party agrees to use Commercially Reasonable And Diligent Efforts
to perform its obligations hereunder, including screening [**see cover
page note], researching, developing, performing Clinical Trials and
commercializing Product(s) for the Field within the Territory, and
providing funding for all of the foregoing.
5.2 Each party shall be responsible for adherence to, and compliance with,
all applicable laws, regulatory guidelines and requirements, and
quality standards for the research, development, manufacture,
Preclinical Studies, and Clinical Trials it performs and for Sales of
Product(s) made by it.
5.3 Each party agrees to make available to the other party all information
produced or obtained by it as a result of performing its obligations
and responsibilities under this Agreement.
5.4 Each party shall xxxx all Product(s) sold by it, and shall cause any
entity authorized by it to sell Product(s) to xxxx all Product(s) sold
by that entity, with the applicable patent number(s) in accordance
with the requirements of applicable laws and regulations in the
country or countries of manufacture and sale.
Article 6. Upfront And Milestone Payments
6.1 COGENCO will pay DMI a non-refundable payment of $500,000 no later
than five (5) days after the Effective Date. This payment represents
reimbursement of some of the research costs incurred by DMI prior to
the Effective Date.
6.2 COGENCO will also pay DMI a non-refundable payment of $2,500,000 no
later than five (5) days after the Effective Date.
6.3 COGENCO will also pay DMI a non-refundable payment of $1,000,000 no
later than five (5) days after the commencement of the first Phase 1
Clinical Trial of a Product suitable for a Major Market Country.
6.4 COGENCO will also pay DMI a non-refundable payment of $2,500,000 no
later than five (5) days after the commencement of the first Phase 2a
or Phase 2 Clinical Trial of a Product suitable for a Major Market
Country.
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6.5 COGENCO will also pay DMI a non-refundable payment of $5,000,000 no
later than five (5) days after the filing of the first NDA for a
Product in a Major Market Country.
6.6 COGENCO will also pay DMI a non-refundable payment of $10,000,000 no
later than five (5) days after the first Regulatory Approval of a
Product in a Major Market Country.
Article 7. Costs Of Screening, Research, Development Clinical
Trials And Commercialization Of Product(s)
7.1 COGENCO agrees to pay all of the costs of the screening of the [**see
cover page note] and of the research, development, Clinical Trials and
commercialization of all Product(s).
7.2 In particular, COGENCO agrees to make the following payments to DMI:
(a) Payment of all the costs for screening of [**see cover page
note], plus an overhead amount to be determined as set forth in
Subsection (i) of this Section 7.2.
(b) Payment of all the costs for research and development of
Product(s), plus an overhead amount to be determined as set forth
in Subsection (i) of this Section 7.2.
(c) Payment of all the costs of conducting [**see cover page note],
Colorado, plus an overhead amount to be determined as set forth
in Subsection (i) of this Section 7.2.
(d) Payment of all the costs for all Preclinical Studies of
Product(s), including Indirect Costs, plus an overhead amount to
be determined as set forth in Subsection (i) of this Section 7.2.
(e) Payment of all the costs for Phase 1 Trials of Product(s),
including Indirect Costs, plus an overhead amount to be
determined as set forth in Subsection (i) of this Section 7.2.
(f) Payment of all the costs for Phase 2 Trials or Phase 2a and Phase
2b Trials of Product(s), including Indirect Costs, plus an
overhead amount to be determined as set forth in Subsection (i)
of this Section 7.2.
(g) Payment of all the costs for Phase 3 Trials of Product(s),
including Indirect Costs, plus an overhead amount to be
determined as set forth in Subsection (i) of this Section 7.2.
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(h) Payment of all the costs for Phase 4 Trials, if any, of
Product(s), including Indirect Costs, plus an overhead amount to
be determined as set forth in Subsection (i) of this Section 7.2.
(i) An overhead amount, as a percentage of total costs, shall be
established by the Advisory Committee independently for each
activity for each year during which the activity will be
performed. Factors to be considered by the Advisory Committee in
establishing the overhead amount include the type of activity,
the stage of the activity (e.g., whether the activity is just
beginning or is near completion), whether it is the first time
that DMI has performed the activity, a realistic and reasonable
assessment of the commitment of personnel and facilities that DMI
must make to the activity at each stage, etc. However, in no
event will the overhead amount be less than DMI's actual Overhead
plus [**see cover page note] % of [**see cover page note]. If the
overhead amount established by the Advisory Committee and paid to
DMI as provided in Subsection (j) of this Section 7.2 is less
than DMI's actual Overhead plus [**see cover page note] % of
[**see cover page note], the deficiency will be paid to DMI as
also provided in Subsection (h) of this Section 7.2.
(j) Payments (a) through (f) shall be made on a periodic basis to be
determined by the Advisory Committee, but no less than quarterly.
Each such payment shall be that amount budgeted by the Advisory
Committee for the upcoming period for activities (a) through (e),
including the appropriate overhead amount, and each such payment
shall be made at least fifteen (15) days prior to the
commencement of the upcoming period. Any overage will be credited
toward the payment for the next period. Any deficiency shall be
added to the payment for the next period or shall be paid sooner
if requested by DMI, in which case the payment of the deficiency
will be made within fifteen (15) days after being requested by
DMI. Interest shall be paid with respect to any payment or any
deficiency in any payment not paid within fifteen (15) days after
being requested by DMI, with the interest rate being 10% over the
Prime Rate and being assessed from the sixteenth day after the
request by DMI for payment until the date the payment is
received.
(k) DMI shall keep such records, books and accounts showing its use
of the payments specified in Subsections (a) through (f) of this
Section 7.2 as the Advisory Committee may require.
Article 8. Sharing Of Revenues; Reports And Records
8.1 COGENCO and DMI will share equally all Profits on Sales of Product(s)
for the Field in the Territory made by either one of them. Payments of
an equal share (i.e. 50%) of a selling party's Profits shall be paid
by the selling party to the other party for each Calendar Quarter in
which Profits are made. Payments shall be due on or before thirty (30)
days after the last day of a Calendar Quarter in which Profits are
made. In the case of any delay in the payment, interest at 2% over the
Prime Rate, assessed from the thirty-first day after the last day of
the Calendar Quarter until the date the payment is received, shall be
due. Each party shall be responsible for paying any and all taxes
levied on account of the payments it receives.
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8.2 COGENCO and DMI will share equally all payments received from
licensees and sublicensees for licenses and sublicenses of their
rights as provided for in Articles 12 and 13, including licensing
fees, sublicensing fees, milestone payments, royalties and any other
payments, however characterized. Payments of an equal share (i.e. 50%)
of a payment received from licensees and sublicensees shall be made no
later than thirty (30) days after its receipt. In the case of any
delay in the payment, interest at 2% over the Prime Rate, assessed
from the thirty-first day after the receipt of the payment from a
licensee or sublicensee until the date the payment is received, shall
be due. Each party shall be responsible for paying any and all taxes
levied on account of the payments it receives.
8.3 All payments shall be made by wire transfer in United States dollars
to the credit of such bank account as may be designated by the
receiving party to the paying party in writing. Any payment which
falls due on a date which is a Saturday, Sunday or a legal holiday in
the United States may be made on the next succeeding day which is not
a Saturday, Sunday or legal holiday.
8.4 Each party shall furnish or cause to be furnished to the other party
on a quarterly basis a written report or reports covering each
Calendar Quarter (each such Calendar Quarter being sometimes referred
to herein as a "reporting period") in which Profits are made and/or in
which payments are received from licensees or sublicensees showing (i)
Sales of each Product in the Territory during the reporting period,
(ii) dispositions of Product(s) other than by sale for cash, (iii)
calculation of Profits for each Product during the reporting period,
(iv) payments received from licensees and sublicensees during the
reporting period, including, for royalty payments and other payments
based on sales of Product(s), a report from the licensees and/or
sublicensees showing the calculation of the royalties or other
payments based on sales of Product(s), (v) the exchange rates used in
converting into dollars from the currencies in which Sales were made
or payments from licensees and sublicensees were received, and (vi)
any other information necessary to establish the accuracy and
completeness of the payments. Reports shall be due thirty (30) days
after the end of each Calendar Quarter in which Profits are made
and/or in which payments are received from licensees or sublicensees.
If a party does not make Profits or receive payments from licensees or
sublicensees in a Calendar Quarter, then that party will so notify the
other party.
14
8.5 Each party shall keep accurate and consistent records and books of
account containing regular entries relating to Sales and to the
manufacture or purchase of Product(s), which records shall contain all
information necessary for the computation of Profits. Such records
shall be available, including for a period of three (3) years after
termination of this Agreement, for examination by representatives of
the other party for the purpose of verifying the accuracy of the
quarterly reports required by Subsection 8.4 and Profits computations
for any year ending no more than 36 months prior to the date of such
examination. Such examination shall be made no more than once in each
Calendar Year during normal business hours with prior notice. Any such
representative shall be entitled to make copies and extracts from such
books and records, but only to the extent necessary to verify the
accuracy of the quarterly reports required by Subsection 8.4 and
Profits computations. Each party shall fully cooperate with such
examination and inspection and shall give any explanations that
reasonably may be requested.
8.6 Upon the written request of a party ("requesting party"), and not more
than once in each Calendar Year, the other party ("audited party")
will permit an independent certified public accounting firm of
recognized standing selected by the requesting party and reasonably
acceptable to the audited party to have access during normal business
hours to those records of the audited party that may be necessary to
verify the accuracy of the quarterly reports required by Subsection
8.4 and calculations of Profits for any year ending no more than 36
months prior to the date of such request.
(a) The accounting firm will disclose to the requesting party only
whether the quarterly reports and Profits calculations are
correct or incorrect, the specific details concerning any
discrepancies, and the corrected amount of Sales and/or Profits.
No other information will be provided to the requesting party.
(b) If the requesting party's independent accounting firm determines
that Profits have been overpaid, the requesting party will repay
the audited party the overage on the same date that the
requesting party delivers to the audited party such accounting
firm's written report. If the requesting party's independent
accounting firm determines that Profits have been underpaid, the
audited party will pay the amount of the additional Profits plus
interest assessed at 2% over the Prime Rate from the time(s) the
payment(s) was(were) originally due. The payment of the
additional Profits and interest will be due no later than fifteen
(15) days after the date on which the requesting party delivers
to the audited party such accounting firm's written report.
(c) The fees charged by the accounting firm will be paid by the
requesting party, provided that, if the audit determines that the
additional Profits payable by the audited party to the requesting
party for such period exceed 5% of the Profits actually paid,
then the audited party will pay the reasonable fees and expenses
charged by such accounting firm.
15
8.7 Each party will treat all financial information of the other party
subject to review under this Article 8 as Proprietary Information in
accordance with Article 16 hereof and will cause its representatives
and accounting firm to enter into an acceptable confidentiality
agreement obligating such representatives and accounting firm to
retain all such financial information in confidence pursuant to the
confidentiality and non-use provisions of Article 16.
Article 9. Advisory Committee
9.1 The parties hereby establish an Advisory Committee to manage,
supervise and coordinate, in accordance with the terms of this
Agreement, all of the activities contemplated by this Agreement,
including the screening of the [**see cover page note] and the
research, development and commercialization of Product(s) for the
Field within the Territory. In particular, but without limitation, the
responsibilities of the Advisory Committee will include:
(a) Approval of Screening Plans, Research And Development Plans,
Clinical Trials Plans, and Commercialization Plans, and
modifications of these plans as necessary or desirable, but no
less than annually.
(b) Approval of DMI's selection of the Lead Candidate and the Backup
Candidate and of DMI's selection of Product(s) for Clinical
Trials. In particular, Product(s) containing the Backup Candidate
may, upon approval by the Advisory Committee, be developed for
the Field in conjunction with, or separately from, the Lead
Candidate.
(c) Approval of the protocols for all Clinical Trials and approval of
the Indication(s) for all Product(s) selected for Clinical
Trials.
(d) Ensuring the existence and quality of Standard Operating
Procedures (SOPs) for compliance with standards of good practice
in all areas of a Product's research, development and
commercialization (e.g., GLP, GCP, GMP, etc.).
(e) Coordination of the manufacture and supply of the Product(s), the
regulatory filings, marketing, post-approval development studies
and all other activities necessary or desirable for the
development and commercialization of the Product(s).
16
(f) Determining if it would be desirable to have [**see cover page
note] licensee be responsible for the development and
commercialization of Product(s) for the Field in all or part of
the Territory and, if it is so determined, selecting any such
licensee and establishing procedures, guidelines, parameters and
strategies in advance for negotiating the license. [**see cover
page note] shall be responsible for negotiating the license, and
the Advisory Committee may advise DMI during this negotiation.
Also, the Advisory Committee must approve the final license
agreement.
(g) Facilitate the exchange of information and the cooperation and
coordination between the parties as they exercise their
respective rights and meet their respective obligations under
this Agreement.
(h) Develop a publication strategy within the guidelines established
in Section 16.
(i) Establish sub-committees as appropriate to facilitate progress,
coordination and cooperation in key areas.
(j) Establish the overhead amounts as provided in Subsection (i) of
Section 7.2.
(k) Perform such other functions as appropriate to further the
purposes of this Agreement.
9.2 The Advisory Committee will be composed of an equal number of
representatives of each party who shall be appointed, and may be
replaced at any time, by such party on written notice to the other
party in accordance with this Agreement. Initially, the Advisory
Committee will be composed of two representatives of each party, but
the number of representatives may be any number subsequently agreed to
by the Advisory Committee. The representatives will be individuals
with expertise in basic research, pre-clinical research, clinical
trials, manufacturing, regulatory filings, marketing and post-approval
development, as applicable to the stage of the development or
commercialization of the Product(s). Any party may designate a
substitute to attend and perform the functions of one of its members
at any meeting of the Advisory Committee by notifying the other party.
DMI shall designate one of its representatives to be the Chairperson
of the Advisory Committee. Within five (5) days after the Effective
Date, each party will notify the other of the identity of its two
initial representatives and DMI will notify COGENCO of the identity of
the Chairperson.
9.3 The Advisory Committee will meet within fifteen (15) days after the
Effective Date and at least once each Calendar Quarter thereafter or
at any other frequency agreed to by the Advisory Committee. The time
and location of the initial meeting shall be determined by the
Co-Chairpersons, and the time and location of subsequent meetings
shall be established by the Advisory Committee. Meetings may be held
in person or by means of a telephone or video conference. The
Co-Chairpersons shall send notices and agendas for each meeting to all
17
of the members of the Advisory Committee. Each party will alternately
be responsible for preparing and delivering to the members of the
Advisory Committee, within thirty (30) days after the date of each
meeting, minutes of such meeting setting forth all decisions of the
Advisory Committee and including a report on the progress of work
performed.
9.4 Within thirty (30) days after the Effective Date, the Advisory
Committee will approve an initial Screening Plan. DMI shall be
responsible for preparing a draft of this initial Screening Plan and
will submit it to the Advisory Committee within fifteen (15) days
after the Effective Date for review, revision and approval of the
Advisory Committee. The Screening Plan will be revised and amended at
least quarterly.
9.5 Within sixty (60) days after the Effective Date, the Advisory
Committee will approve an initial Research And Development Plan. DMI
shall be responsible for preparing a draft of this initial Research
And Development Plan and will submit it to the Advisory Committee
within forty-five (45) days after the Effective Date for review,
revision and approval of the Advisory Committee. The Research And
Development Plan will be revised and amended at least annually.
9.6 Within such time agreed to by the Advisory Committee, the Advisory
Committee will approve an initial Clinical Trials Plan. DMI shall be
responsible for preparing a draft of this initial Clinical Trials Plan
and will submit it to the Advisory Committee within such time agreed
to by the Advisory Committee, for review, revision and approval of the
Advisory Committee. The Clinical Trials Plan will be revised and
amended at least annually.
9.7 Within such time agreed to by the Advisory Committee, the Advisory
Committee will approve an initial Commercialization Plan. DMI shall be
responsible for preparing a draft of this initial Commercialization
Plan and will submit it to the Advisory Committee within such time
agreed to by the Advisory Committee, for review, revision and approval
of the Advisory Committee. The Commercialization Plan will be revised
and amended at least annually.
9.8 The objective of the Advisory Committee will be to reach agreement by
consensus on all matters. In the event that the members do not reach
consensus with respect to any matter, a vote will be taken. Each
representative will have one vote. All major decisions about the
screening of [**see cover page note] and the research, development and
commercialization of the Product(s) shall be made by majority vote of
the representatives. In the event of a tie vote, the matter will be
resolved as provided in Article 23. All decisions about the licensing
of a [**see cover page note] licensee pursuant to Section 12.2 shall
be made by a [**see cover page note] vote of the representatives. In
the event the vote is not [**see cover page note], the matter will be
resolved as provided in Article 23.
18
Article 10. Regulatory Filings
10.1 Prior to submitting any IND or other Drug Approval Application, the
parties shall consult with each other regarding the scope and general
content of such IND or Drug Approval Application. Each party shall
have the right to review and comment on all INDs and Drug Approval
Applications prior to filing in accordance with specific time lines or
other arrangements agreed upon by the Advisory Committee, and such
comments will be given all due consideration by the other party.
10.2 Regulatory documents for each filing will be owned and centralized and
held at DMI's offices or the offices of DMI's Third Party Contractors,
but will be made available to COGENCO for its review.
10.3 DMI shall not have the right to transfer title or otherwise attempt in
any manner to dispose of any INDs or Drug Approval Applications
without the written consent of COGENCO.
10.4 DMI shall be responsible for conducting meetings and discussions and
routine telephone communications with the regulatory authority related
to the Clinical Trials it is performing. All parties may participate
in all substantive discussions and meetings with regulatory
authorities. COGENCO will send only a reasonable number of
representatives to any such discussion or meeting.
10.5 The parties shall cooperate in good faith with respect to the conduct
of any inspections by any regulatory authority of DMI's or a Third
Party Contractor's sites and facilities related to a Product, and both
parties shall, at a minimum, be given the opportunity to attend the
summary, or wrap up, meeting related to the Product with such
regulatory authority at the conclusion of such site inspection. If
DMI's sites or facilities are being inspected, DMI shall consider the
attendance of COGENCO at the inspections, but shall not be obligated
to accept COGENCO's attendance at such inspections if such attendance
would result in the disclosure to COGENCO of confidential information
or trade secrets unrelated to Product(s).
19
10.6 To the extent that DMI receives written or material oral
communications from a regulatory authority relating to a Product or a
Clinical Trial, DMI shall notify COGENCO and provide a copy of any
written communication as soon as reasonably practicable.
10.7 During a Clinical Trial, DMI shall be responsible for the prompt
reporting of adverse reactions (as defined by the World Health
Organization) directly or indirectly attributable to the use of the
Product being used in the Clinical Trial to the regulatory authority
in compliance with applicable law. After Regulatory Approval of a
Product, DMI shall continue to be responsible for the prompt reporting
of any adverse reactions directly or indirectly attributable to the
use of the Product to the appropriate regulatory authorities in
compliance with applicable law. COGENCO shall immediately inform DMI
of any adverse drug reactions of which it becomes aware.
Article 11. Intellectual Property
11.1 As of the Effective Date, DMI is the sole and exclusive owner of
Intellectual Property covering or relating to the use of [**see cover
page note] to treat asthma in humans, including the patent and patent
applications listed in Appendix A attached hereto. DMI shall remain
the owner of this Intellectual Property.
11.2 DMI shall also be the sole and exclusive owner of all Intellectual
Property concerning or relating to (i) the treatment of asthma with a
[**see cover page note], including all methods of treatment, any such
compounds and/or products comprising any such compounds, (ii) the
Selected Candidates, including any derivatives of them, and/or (iii)
Product(s), which is conceived, created, discovered, produced or
developed by either party and/or by assignees, licensees,
sublicensees, consultants and/or Affiliates of either party or both
parties and/or by Third-Party contractors of DMI during the term of
this Agreement.
11.3 COGENCO agrees to make prompt written disclosure to DMI of all
Intellectual Property concerning or relating to (i) the treatment of
asthma with a [**see cover page note], including all methods of
treatment, any such compounds and/or products comprising any such
compounds, (ii) the Selected Candidates, including any derivatives of
them, and/or (iii) Product(s) which is conceived, created, discovered,
produced or developed by it, its assignees, its sublicensees, its
consultants and/or its Affiliates during the term of this Agreement.
11.4 COGENCO agrees to require its sublicensees and consultants to assign
to COGENCO all Intellectual Property concerning or relating to (i) the
treatment of asthma with a [**see cover page note], including all
methods of treatment, any such compounds and/or products comprising
any such compounds, (ii) the Selected Candidates, including any
derivatives of them, and/or (iii) Product(s) which is conceived,
created, discovered, produced or developed by any of them during the
term of the sublicense or consultant's agreement.
20
11.5 COGENCO also agrees to require its assignees and Affiliates to assign
to COGENCO all Intellectual Property concerning or relating to (i) the
treatment of asthma with a [**see cover page note], including all
methods of treatment, any such compounds and/or products comprising
any such compounds, (ii) the Selected Candidates, including any
derivatives of them, and/or (iii) Product(s) which is conceived,
created, discovered, produced or developed by, or on behalf of, any of
them during the term of this Agreement.
11.6 COGENCO agrees to, and does hereby, assign to DMI all of its right,
title and interest in and to all Intellectual Property concerning or
relating to (i) the treatment of asthma with a [**see cover page
note], including all methods of treatment, any such compounds and/or
products comprising any such compounds, (ii) the Selected Candidates,
including any derivatives of them, and/or (iii) Product(s) which is
conceived, created, discovered, produced or developed by it, its
assignees, sublicensees, consultants and/or Affiliates during the term
of this Agreement.
11.7 COGENCO will assist DMI, at DMI's expense, in every proper way to
obtain, maintain and enforce United States and foreign proprietary
rights relating to any and all Intellectual Property now or hereafter
owned by DMI which concerns or relates to (i) the treatment of asthma
with a [**see cover page note], including all methods of treatment,
any such compounds and/or products comprising any such compounds, (ii)
the Selected Candidates, including any derivatives of them, and/or
(iii) Product(s). To that end, COGENCO will:
(a) Execute, verify and deliver such documents and perform such other
acts (including providing evidence and witnesses within its
control and appearing as a witness) as DMI may reasonably request
for use in applying for, obtaining, perfecting, evidencing,
sustaining and enforcing such proprietary rights.
(b) Where the assignment of proprietary rights to DMI is provided for
herein, execute, verify and deliver assignments of such
proprietary rights to DMI or its designee.
(c) In the event DMI is unable for any reason, after reasonable
effort, to secure COGENCO's signature on any document needed in
connection with the actions specified in this Article 11, COGENCO
hereby irrevocably designates and appoints DMI and its duly
authorized officers and agents as its agent and attorney-in-fact,
to act for and on COGENCO's behalf to execute, verify and file
any such documents and to do all other lawfully permitted acts to
further the purposes of this Article 11 with the same legal force
and effect as if executed by COGENCO.
21
11.8 DMI will take all necessary steps to obtain and maintain protection
for all Intellectual Property now or hereafter owned by it, and DMI
shall be responsible for, and shall bear all the costs of, obtaining
and maintaining protection for its Intellectual Property.
11.9 DMI shall keep COGENCO advised as to all developments and shall
provide COGENCO with all materials sufficiently in advance to allow
COGENCO to review and provide input on any proposed filing prior to
its filing, which input shall be considered in good faith and included
where reasonably possible by DMI. Notwithstanding the foregoing, DMI
shall have the right to take such actions as are reasonably necessary,
in its good faith judgment, to preserve all rights in its Intellectual
Property, and DMI shall notify COGENCO as soon as possible after
taking any such action.
11.10 DMI will abandon Intellectual Property or any rights therein, only
after notice to COGENCO at least thirty (30) days in advance and only
after giving COGENCO an opportunity to assume responsibility for
obtaining and/or maintaining the Intellectual Property protection
proposed to be abandoned.
11.11 The parties agree to share equally the costs (including attorney's
fees, license fees, milestone payments, royalties and any other costs)
should it become necessary for DMI and/or COGENCO to acquire or
license the Intellectual Property of one or more Third Parties in
order to be able to make, have made, use, sell, offer for sale,
market, commercialize, import and export Product(s) for the Field in
the Territory.
11.12 DMI shall have the right, with the approval of COGENCO, to assign its
Intellectual Property covering or relating to the use of [**see cover
page note] to treat asthma in humans to Third Parties in all or part
of the Territory, provided the assignee agrees to assume all of DMI's
obligations and responsibilities under this Agreement in all, or the
assignee's part, of the Territory.
22
Article 12. Licenses Of Third Parties
12.1 DMI shall have the right to license its Intellectual Property covering
or relating to the use of [**see cover page note] to treat asthma in
humans to Third Parties in all or part of the Territory for the
treatment of asthma with the approval of COGENCO.
12.2 The Parties contemplate that they are likely to want to have a [**see
cover page note] licensee be responsible for the development and
commercialization of Product(s) for the Field in all or a part of the
Territory. In such a case, the Advisory Committee will select the
[**see cover page note] licensee, and [**see cover page note] will
negotiate any such license, all as provided in Article 9, [**see cover
page note] agrees to license its Intellectual Property to the licensee
selected by the Advisory Committee as necessary to effectuate the
terms of the license negotiated by [**see cover page note] and
approved by the Advisory Committee.
Article 13. Co-Marketing Rights
13.1 In the event the parties enter into one or more licenses as provided
in Section 12.2 above, [**see cover page note] shall retain the right,
but not the responsibility or obligation, for DMI and COGENCO - to
market and/or promote Product(s) for the Field within the Territory or
part of the Territory - that is licensed ("Co-Marketing Rights").
These Co-Marketing Rights shall include the right to make, have made,
use, sell, offer for sale, commercialize, import and export Product(s)
to the extent necessary for DMI and COGENCO to be able to market
and/or promote Product(s) for the Field within the Territory or part
of the Territory that is licensed.
13.2 DMI hereby grants to COGENCO a license of all of its Intellectual
Property covering or relating to the treatment of asthma in humans
with a [**see cover page note] to the extent needed by COGENCO to
fully exercise the Co-Marketing Rights it receives pursuant to the
terms of Section 13.1.
13.3 DMI shall have the right to license its Co-Marketing Rights to Third
Parties with the approval of COGENCO.
13.4 COGENCO shall have the right to sublicense its Co-Marketing Rights to
Third Parties with the approval of DMI.
Article 14. Third-Party Contractors
14.1 DMI may enter into written contracts with Third Parties to perform
activities required of it under the terms of this Agreement or in
furtherance of the goals of this Agreement, including, without
limitation, Third-Party manufacturers, consultants, clinical
investigators and contract research organizations.
23
14.2 Any such Third-Party contractors must agree to adhere to all
applicable laws, regulatory guidelines and requirements, and quality
standards for the research, development, manufacture, Preclinical
Studies and Clinical Trials it performs and must agree to use only
qualified personnel to perform the work which is the subject of the
Third-Party contract.
14.3 All Third-Party contractors must also agree to be bound by
confidentiality and nonuse provisions which are substantially the same
as those contained in Article 15.
14.4 All Third-Party contractors must further agree to assign any
Intellectual Property conceived, created, discovered, produced or
developed as a result of the Third Party's performance under the
contract to DMI.
14.5 All Third-Party contracts for the manufacture and/or supply of
Product(s) or for the performance of Preclinical Studies or Clinical
Trials must be approved in advance by the Advisory Committee.
14.6 Third-Party contracts are distinguished herein from licenses and
sublicenses because no payments are made by the Third-Party
contractors to DMI and/or COGENCO pursuant to the terms of a
Third-Party contract. Thus, any contract under which payments are made
by a Third Party to DMI and/or COGENCO, including agreements with
distributors of Product(s), shall be classified as a license or
sublicense hereunder.
Article 15. Confidentiality
15.1 Each party agrees to treat and maintain any of the other party's
Proprietary Information which is in its possession, which comes into
its possession during the term of this Agreement, or which is
conceived, created, discovered, produced, developed or obtained by the
other party as a result of performance under this Agreement, in
confidence, and agrees not to disclose any such Proprietary
Information to anyone and to not use any such Proprietary Information,
except for the purposes of performing its obligations under this
Agreement. Notwithstanding the foregoing, each party may disclose the
other party's Proprietary Information to its employees, consultants,
agents, and Third-Party contractors, or as is deemed necessary for any
purpose set forth in, or relating to, this Agreement, provided that
any recipients are bound by like duties of confidentiality,
nondisclosure and nonuse as contained herein. Further, each party may
disclose and use the other party's Proprietary Information with the
written consent of the other party.
24
15.2 Notwithstanding the foregoing, each party may disclose the existence
and content of this Agreement and other agreements between the parties
to advisors, agents, consultants, investors, and Third-Party
contactors who agree to be bound by like duties of confidentiality,
nondisclosure and nonuse as contained herein.
15.3 Nothing contained herein shall in any way restrict or impair the right
of either party to use, disclose, or otherwise deal with the other
party's Proprietary Information which the party claiming waiver can
demonstrate by written records:
(a) is or becomes generally known to the public through no fault of
the party;
(b) was known to it prior to the time of disclosure by the other
party;
(c) was independently developed by it and not in performance of its
obligations under this Agreement;
(d) was lawfully obtained without restrictions from a Third Party who
has authority to make such disclosure; or
(e) which the party is required to disclose pursuant to applicable
law or pursuant to a requirement, subpoena, order or other
request of a court, agency or other governmental entity,
including required disclosures to a governmental entity or agency
in connection with seeking any governmental or regulatory
approval; in such case, the party shall notify the other party
prior to such disclosure so as to give the other party an
opportunity to protest the disclosure.
Article 16. Publicity, Publications And Presentations
16.1 The parties agree that the public announcement of the execution of
this Agreement shall be in the form of a press release to be agreed on
by the parties before or on the Effective Date and, thereafter, each
party shall be entitled to make or publish any public statement
consistent with the contents thereof. Thereafter, the parties will
jointly discuss and agree on any statement to the public regarding
this Agreement, the transactions contemplated herein, or clinical,
regulatory and commercial developments relating to the Product(s),
subject in each case to disclosure otherwise required by law or
regulation as determined in good faith by each party. When a party
wishes to make a public statement, it will notify the other party and
give the other party at least three (3) business days to review and
comment on such statement, and the parties will discuss and agree on
the final content of the statement. If a party is not legally able to
give notice as required by the previous sentence, it will furnish the
25
other party with a copy of its disclosure as soon as practicable after
the making thereof. The parties acknowledge the importance of
supporting each other's efforts to publicly disclose results and
significant developments regarding Product(s). The principles to be
observed in such public disclosures will be accuracy, the
confidentiality requirements of Article 15, compliance with regulatory
agency regulations and guidelines, the advantage a competitor may gain
from any public statements under this Subsection 16.1, and the
standards and customs in the pharmaceutical industry for such
disclosures by companies comparable to DMI and COGENCO.
16.2 DMI and COGENCO each acknowledge the other party's interest in
publishing certain of the results of the work performed pursuant to
the terms of this Agreement and in making presentations at scientific
meetings to (i) obtain recognition within the scientific community,
(ii) advance the state of scientific knowledge, and (iii) promote the
Product(s). Both parties also recognize their mutual interest in
obtaining valid patent rights for any inventions concerning or
relating to the use of [**see cover page note] for the treatment of
asthma, the Selected Candidates, including derivatives of them, and/or
Product(s) and in protecting the confidentiality of their Proprietary
Information.
(a) Consequently, if either party desires to publish or present the
results of the work performed pursuant to the terms of this
Agreement, the publishing/presenting party shall provide the
nonpublishing/nonpresenting party and the Advisory Committee with
a draft manuscript of the proposed publication or presentation.
(b) The nonpublishing/nonpresenting party and the Advisory Committee
shall have thirty (30) days from receipt of the draft manuscript
to review it.
(c) The publishing/presenting party agrees to delete any information
identified by the nonpublishing/nonpresenting party as its
Proprietary Information upon written request of the
nonpublishing/nonpresenting party received within the thirty-day
review period.
(d) The publishing/presenting party also agrees to delete any
information identified by the Advisory Committee as Proprietary
Information, the deletion of which is necessary for the
protection of the commercial interests of the parties, upon
written request of the Advisory Committee received within the
thirty-day review period.
(e) If the Advisory Committee objects in writing within the
thirty-day review period to the publication or presentation as
being inconsistent with the publication strategy established by
the Advisory Committee pursuant to Section 9.1, then the
publishing/presenting party and the Advisory Committee will
discuss in good faith possible modifications of, or delays in,
the publication or presentation. The publishing/presenting party
shall have the right to proceed with the publication or
presentation if an agreement with the Advisory Committee about
the proposed modifications or delays cannot be reached within
thirty days after receipt of the written objection.
26
(f) Finally, in the event that the nonpublishing/nonpresenting party
or the Advisory Committee determines that the manuscript
describes patentable subject matter, the
nonpublishing/nonpresenting party and/or the Advisory Committee
shall so notify the publishing/presenting party in writing within
the thirty-day review period. Upon receipt of this notification,
the publishing/presenting party will delay publication of the
manuscript or the presentation of the information contained in
the manuscript for a period of ninety (90) days from the date of
receipt of the written notice.
Article 17. Representations, Warranties And Disclaimer
17.1 DMI represents and warrants that it has the right and authority to
enter into, and perform its obligations under, this Agreement and that
there are no outstanding grants, licenses, encumbrances or agreements,
either written, oral or implied, inconsistent with this Agreement, or
which this Agreement, or performance hereunder, would violate, breach,
conflict with, or cause a default.
17.2 DMI represents and warrants that it is the sole and exclusive owner of
the patent and patent applications listed in Appendix A.
17.3 DMI further represents and warrants that it has the full right and
authority to grant COGENCO all of the rights granted hereunder.
17.4 COGENCO represents and warrants that it has the right and authority to
enter into, and perform its obligations under, this Agreement and that
there are no outstanding grants, licenses, encumbrances or agreements,
either written, oral or implied, inconsistent with this Agreement, or
which this Agreement, or performance hereunder, would violate, breach,
conflict with, or cause a default.
17.5 EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 17, DMI DOES NOT MAKE
ANY EXPRESS OR IMPLIED WARRANTIES, STATUTORY OR OTHERWISE, CONCERNING
THE INTELLECTUAL PROPERTY OR PROPRIETARY INFORMATION IT CURRENTLY OWNS
AND WHICH IT IS LICENSING TO COGENCO HEREUNDER. SPECIFICALLY, WITHOUT
LIMITING THE GENERALITY OF THE FOREGOING, DMI MAKES NO EXPRESS OR
IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS (FOR A PARTICULAR PURPOSE
OR OTHERWISE), QUALITY OR USEFULNESS OF ITS INTELLECTUAL PROPERTY OR
PROPRIETARY INFORMATION. DMI DOES NOT WARRANT THE ACCURACY OF ANY
27
INFORMATION INCLUDED WITHIN THE INTELLECTUAL PROPERTY OR PROPRIETARY
INFORMATION OR THAT THE PRACTICE OF ITS INTELLECTUAL PROPERTY OR THE
USE OF ITS PROPRIETARY INFORMATION WILL BE FREE FROM CLAIMS OF
INFRINGEMENT BY THIRD PARTIES OR ANY OTHER RIGHTS OF THIRD PARTIES.
UNDER NO CIRCUMSTANCE SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY
OR ANY THIRD PARTY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES IN
TORT, CONTRACT, STRICT LIABILITY OR OTHERWISE INCURRED BY THE OTHER
PARTY OR ANY THIRD PARTY.
Article 18. Defense Of Third-Party Claims
18.1 With respect to claims or suits by Third Parties resulting from, or
arising out of, the performance of this Agreement, the parties hereto
agree as follows:
(a) Each party shall have the right to control the defense or
settlement of any claim or suit that may be brought against it
with counsel of its own choosing and at its own expense.
(b) Each party agrees to inform the other party as soon as
practicable of any such claim or suit and to keep the other party
informed about the claim or suit until resolved.
(c) Each party agrees to cooperate with the other party to the extent
necessary with respect to defending against any such claim or
suit. All of the cooperating party's expenses shall be paid for,
or reimbursed by, the other party.
(d) Each party agrees that it will not settle any claim or suit
brought against it without the input of the other party, which
input will be considered in good faith.
18.2 Notwithstanding the foregoing, a party seeking indemnification from
the other party must proceed as provided in the indemnification
provisions of Article 20.
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Article 19. Infringement Or Misappropriation By Third Parties
19.1 Each party will inform the other as soon as possible upon learning of
any infringement or misappropriation by any Third Party of any
Intellectual Property currently or hereafter owned by DMI.
19.2 DMI shall have the first option to proceed against such Third Party.
COGENCO agrees that it will permit the use of its name in any
litigation suit, will sign all necessary papers, will take all
rightful oaths, and will do whatever else may be necessary to assist
DMI in proceeding against the Third Party. All costs, expenses and
disbursements of proceeding against such Third Party shall be borne by
DMI, including reimbursement of expenses incurred by COGENCO as a
result of assisting DMI in proceeding against the Third Party. DMI
shall keep COGENCO fully informed of all such proceedings. DMI shall
not settle any such proceeding without the input of COGENCO, which
input will be considered in good faith. In the event that DMI is
successful in proceeding against the Third Party, all monies recovered
by DMI for infringement or misappropriation by way of settlement or
order of court shall be treated as follows. If it has not already done
so, DMI shall deduct and reimburse COGENCO the attorneys fees,
disbursements and costs expended by COGENCO in the conduct of
proceeding against the Third Party. Next, DMI shall deduct and retain
the attorneys fees, disbursements and costs expended by DMI in the
conduct of proceeding against the Third Party. Any monies remaining
after such deduction shall be divided as follows [**see cover page
note] % to DMI and [**see cover page note] % to COGENCO.
19.3 In the event that DMI elects not to proceed, COGENCO shall have the
right to proceed against the Third Party. DMI agrees that it will
permit the use of its name in any litigation suit, will sign all
necessary papers, will take all rightful oaths, and will do whatever
else may be necessary to assist COGENCO in proceeding against the
Third Party. All costs, expenses and disbursements of proceeding
against such Third Party shall be borne by COGENCO, including
reimbursement of expenses incurred by DMI as a result of assisting
COGENCO in proceeding against the Third Party. COGENCO shall keep DMI
fully informed of all such proceedings. COGENCO shall not settle any
such proceeding without the prior written consent of DMI, which
consent will not be unreasonably withheld or conditioned. In the event
that COGENCO is successful in proceeding against the Third Party, all
monies recovered by COGENCO for infringement or misappropriation by
way of settlement or order of court shall be treated as follows. If it
has not already done so, COGENCO shall deduct and reimburse DMI the
attorneys fees, disbursements and costs expended by DMI in the conduct
of proceeding against the Third Party. Next, COGENCO shall deduct and
retain the attorneys fees, disbursements and costs expended by COGENCO
in the conduct of proceeding against the Third Party. Any monies
remaining after such deduction shall be divided as follows: [**see
cover page note] % to COGENCO and [**see cover page note] % to DMI.
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Article 20. Indemnification
20.1 COGENCO hereby agrees to indemnify, defend and hold harmless DMI, its
officers, directors, employees, consultants and agents from and
against any and all liabilities, claims, demands, actions, suits,
damages, costs, expenses (including reasonable attorneys' fees), or
judgments (collectively "Damages") arising out of, based upon,
resulting from, or presented or brought on account of, a material
breach of this Agreement by COGENCO, except to the extent that such
Damages arise out of, are based upon or result from (i) a material
breach of the Agreement by DMI or (ii) the negligence or willful
misconduct of DMI.
20.2 DMI hereby agrees to indemnify, defend and hold harmless COGENCO, its
officers, directors, employees, consultants and agents, from and
against any liabilities, claims, demands, actions, suits, damages,
costs, expenses (including reasonable attorneys' fees), or judgments
(collectively "Damages") arising out of, based upon, resulting from,
or presented or brought on account of, a material breach of this
Agreement by DMI, except to the extent that such Damages arise out of,
are based upon or result from (i) a material breach of the Agreement
by COGENCO or (ii) the negligence or willful misconduct of COGENCO
20.3 COGENCO hereby agrees to indemnify, defend and hold harmless DMI, its
officers, directors, employees, consultants and agents, from and
against any liabilities, claims, demands, suits, actions, damages,
costs, expense (including reasonable attorneys' fees), or judgments
(collectively "Damages") arising out of, based upon, resulting from,
or presented or brought on account of, any injuries, losses or damages
sustained by any person or property in consequence of any act or
omission of COGENCO, except to the extent that such Damages arise out
of, are based upon or result from (i) a material breach of the
Agreement by DMI or (ii) the negligence or willful misconduct of DMI.
20.4 DMI hereby agrees to indemnify, defend and hold harmless COGENCO, its
officers, directors, employees, consultants and agents, from and
against any liabilities, claims, demands, suits, actions, damages,
costs, expense (including reasonable attorneys' fees), or judgments
(collectively "Damages") arising out of, based upon, resulting from,
or presented or brought on account of, any injuries, losses or damages
sustained by any person or property in consequence of any act or
omission of DMI, except to the extent that such Damages arise out of,
are based upon or result from (i) a material breach of the Agreement
by COGENCO or (ii) the negligence or willful misconduct of COGENCO.
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20.5 A party entitled to indemnification under this Article 20 (the
"Indemnified Party") shall promptly notify the party potentially
responsible for such indemnification (the "Indemnifying Party") upon
becoming aware of any claim or claims asserted or threatened against
such Indemnified Party which could give rise to a right of
indemnification under this Agreement; provided, however, that the
failure to give such notice shall not relieve the Indemnifying Party
of its indemnity obligation hereunder, except to the extent that such
failure substantially prejudices its rights hereunder.
20.6 The Indemnifying Party shall have the right to defend, at its sole
cost and expense, such claim by all appropriate proceedings, which
proceedings shall be prosecuted diligently by the Indemnifying Party
to a final conclusion or settled at the discretion of the Indemnifying
Party; provided, however, that the Indemnifying Party may not enter
into any compromise or settlement unless the Indemnified Party
consents thereto, which consent shall not be unreasonably withheld,
conditioned or delayed.
20.7 The Indemnified Party may participate in, but not control, the defense
or settlement of any claim controlled by the Indemnifying Party
pursuant to this Article 20 and shall bear its own costs and expenses
with respect to such participation; provided, however, that the
Indemnifying Party shall bear such costs and expenses if counsel for
the Indemnifying Party shall have reasonably determined that such
counsel may not properly represent both the Indemnifying Party and the
Indemnified Party.
20.8 If the Indemnifying Party fails to notify the Indemnified Party within
twenty (20) days after receipt of notice of a claim in accordance with
Section 20.5 hereof that it elects to defend the Indemnified Party
pursuant to this Article 20, or if the Indemnifying Party elects to
defend the Indemnified Party but fails to prosecute or settle the
claim diligently and promptly, then the Indemnified Party shall have
the right to defend, at the sole cost and expense of the Indemnifying
Party, the claim by all appropriate proceedings, which proceedings
shall be promptly and vigorously prosecuted by the Indemnified Party
to a final conclusion or settlement; provided, however, that in no
event shall the Indemnifying Party be required to indemnify the
Indemnified Party for any amount paid or payable by the Indemnified
Party in the settlement of any such claim agreed to without the
consent of the Indemnifying Party, which consent shall not be
unreasonably withheld, conditioned or delayed.
Article 21. Insurance
21.1 Each Party shall use all commercially reasonable efforts to maintain
insurance, including product liability insurance, with respect to its
activities hereunder.
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21.2 Such insurance shall be in such amounts and subject to such
deductibles as the Parties may agree based upon standards prevailing
in the industry at the time.
21.3 Up until such time as Clinical Trials begin, either Party may satisfy
its obligations under this Section through self-insurance to the same
extent.
21.4 At such time as a Product(s) is being manufactured by a Party for
commercial sale, that Party shall name the other Party as an
additional insured on any such policies. Any insurance shall not be
construed to create a limit of the insuring Party's liability with
respect to its indemnification obligations under Article 20. Each
Party shall use commercially reasonable efforts to provide the other
Party with written notice at least thirty (30) prior to a
cancellation, non-renewal or material change in such insurance or
self- insurance that could materially adversely affect the rights of
the other Party hereunder. Each Party's insurance hereunder shall be
primary and non- contributing.
Article 22. Term And Termination
22.1 Unless terminated sooner as provided below, this Agreement will
continue in full force and effect until the later of (i) such time
after the First Commercial Sale when no Sales of any Product(s) for
the Field have been made anywhere in the Territory for a period of one
(1) year by either party or by any licensees, sublicensees and/or
assignees of one or both of the parties, (ii) one (1) year after the
termination of all licenses and sublicenses, or (iii) fifty (50) years
from the Effective Date.
22.2 The parties may at any time terminate this Agreement, in part or in
its entirety, by mutual written agreement.
22.3 DMI shall have the right to terminate this Agreement immediately by
providing written notice to COGENCO of the termination if one or both
of the two cash payments provided for in Subsections 6.1 and 6.2 are
not received within five (5) days after the Effective Date.
22.4 Other than as provided in Section 22.3, in the event of a breach or
default in respect of any of the terms of this Agreement by either
party, the other party shall give notice in writing, specifying in
detail the nature of the breach or default. If the alleged breach or
default is not cured within sixty (60) days after receipt of this
notice, the party giving notice shall have the right to immediately
terminate this Agreement by giving a second written notice to the
breaching party.
22.5 In the event of either party experiencing financial difficulties, that
party shall immediately notify the other party to that effect. The
party so notified shall have the right to terminate this Agreement
within thirty (30) days of said notification. If the party having the
right to terminate decides not to do so, then the parties agree to
renegotiate in good faith a reduction in the share of the Revenues to
be paid to the party experiencing financial difficulties if that party
is unable to fully perform its obligations hereunder. A party shall be
considered as having financial difficulties by:
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(a) that party's commencement of a voluntary case under any
applicable bankruptcy code or statute, or by its authorizing, by
appropriate proceedings, the commencement of such a voluntary
case;
(b) that party's failing to receive dismissal of any involuntary case
under any applicable bankruptcy code or statute (wherein the
other party is not a party to the case) within sixty (60) days
after initiation of such action or petition;
(c) that party's seeking relief as a debtor under any applicable law
of any jurisdiction relating to the liquidation or reorganization
of debtors or to the modification or alteration of the rights of
creditors, or by consenting to or acquiescing in such relief;
(d) the entry of an order by a court of competent jurisdiction
finding it to be bankrupt or insolvent, or ordering or approving
its liquidation, reorganization, or any modification or
alteration of the rights of its creditors, or assuming custody
of, or appointing a receiver or other custodian for, all or a
substantial part of its property or assets; or
(e) that party's making an assignment for the benefit of, or entering
into a composition with, its creditors, or appointing or
consenting to the appointment of a receiver or other custodian
for all or a substantial part of its property.
22.6 Upon termination of this Agreement for any reason:
(a) All rights and licenses granted to COGENCO hereunder shall revert
to DMI, except that COGENCO shall have the right to sell any
Product(s) in inventory as provided in Subsection (b) of this
Section 22.6.
(b) COGENCO shall cease all activities with respect to the
Product(s), including all making (by COGENCO and/or by Third
Parties for COGENCO), using, selling, offering for sale,
marketing, commercializing, importing and exporting of
Product(s). Notwithstanding the foregoing, COGENCO shall have the
right to sell any Product(s) in inventory at prices of its
choosing, provided COGENCO makes the payments and reports
required by Article 8.
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(c) If requested by DMI, COGENCO shall make its personnel and other
resources reasonably available to DMI as necessary for a
reasonable period of time, not to exceed six (6) months from the
date of termination, to effect an orderly transition of
responsibilities. If termination of the Agreement occurred
because of a breach by COGENCO, then COGENCO will be responsible
for all of the costs of performing these obligations. If
termination of the Agreement occurred because of a breach by DMI,
then DMI will be responsible for all of the costs of performing
these obligations. Otherwise, the parties will share the costs.
(d) COGENCO's sublicense(s) of its rights pursuant to Section 13.4
above (referred to herein as "Article 13 Sublicense(s)") shall be
transferred to DMI. The Article 13 Sublicense(s) will remain in
full force and effect so long as the sublicensee(s) perform(s)
the obligations of the Article 13 Sublicense(s), and DMI shall
have all of the rights and benefits of the Article 13
Sublicense(s) (including the right to receive 100% of all
payments due under the Article 13 Sublicense(s)) and shall be
responsible for performing all of the obligations required of
COGENCO by the Article 13 Sublicense(s). COGENCO will execute
such documents as may be requested by DMI to attest to the
transfer to DMI of all of its Article 13 Sublicense(s).
22.7 Upon termination of this Agreement for any reason, nothing herein
shall be construed to release either party from any obligation matured
prior to the effective date of such termination, and neither party
waives any rights it may have to remedies arising out of the
termination or breach of surviving obligations.
Article 23. Dispute Resolution
23.1 In the event of any controversy or claim arising out of or relating to
any provision of this Agreement or the collaborative effort
contemplated hereby, the parties shall initially refer such dispute to
the Advisory Committee.
23.2 Failing resolution by the Advisory Committee of any controversy or
claim within thirty (30) days after such referral, the matter shall be
referred to the Chief Executive Officers (CEOs) of DMI and COGENCO.
Any controversy or claim arising in the Advisory Committee or any
matter about which the Advisory Committee is deadlocked shall also be
referred to the CEOs of DMI and COGENCO
23.3 The CEOs of DMI and COGENCO shall, as soon as practicable, attempt in
good faith to resolve any controversy or claim referred to them. If
such controversy or claim is not resolved within thirty (30) days
after referral to the CEOs of DMI and COGENCO, either party shall be
free to notify the CEOs of DMI and COGENCO, that it wishes the matter
to be referred to the Chief Scientific Officer of DMI. The decision of
the Chief Scientific Officer of DMI shall be final.
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23.4 This Agreement shall be governed by, and its provisions construed and
enforced in accordance with, the law of the State of Colorado. Both
parties agree to submit to the jurisdiction of all Colorado courts,
including federal courts, and to waive any and all rights under the
law of any jurisdiction to object on any basis to jurisdiction or
venue within Colorado.
Article 24. Miscellaneous
24.1 All payments, notices, reports, exchanges of information and other
communications between the parties required by this Agreement shall be
sent to the addresses set out below, or to such other addresses as may
be designated by one party to the other by notice pursuant hereto, by
(i) prepaid, certified air mail (which shall be deemed received by the
other party on the fifth business day following deposit in the mails),
(ii) facsimile transmission or other electronic means of communication
(which shall be deemed received when transmitted), with confirmation
by first class letter, postage prepaid, or (iii) an express courier
service, such as FedEx, DHL, Airborne or similar delivery service,
with capabilities of tracking packages and/or letter delivery and
providing verification of receipt (in the even of the use of such a
service, receipt shall be on the date actually received, as verified
by such delivery service).
If to DMI: DMI BioSciences Inc.
0000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxx, XXX 00000-0000
Attention: Xx. Xxxxx X. Xxxxxx
If to COGENCO: Cogenco International, Inc.
0000 Xxxxx Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: Xx. Xxxxx Xxxxxxx
24.2 No party to this Agreement shall be liable for failure to perform on
its part any provision or part of this Agreement when such failure is
due to fire, flood, strike or other industrial disturbance,
unavoidable accident, war, embargo, inability to obtain materials,
transportation controls, governmental actions, or other causes beyond
the control of such party, but only for the period of delay imposed by
such cause.
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24.3 For purposes of this Agreement, "business day" means a day on which
the banks in the United States are generally open to conduct their
regular banking business.
24.4 Should any part or provision of this Agreement be held unenforceable
or in conflict with the law, the validity of the remaining parts or
provisions shall not be affected by such holding.
24.5 The failure of either party to enforce, at any time and for any period
of time, a provision of this Agreement is not, and shall not be
construed to be, a waiver of any such provision or of the right of
such party to subsequently enforce each and every such provision.
24.6 This Agreement constitutes the entire agreement and understanding
between the parties with respect to the subject matter hereof, and
supersedes and replaces all prior negotiations, understandings and
agreements, whether written or oral, including the Term Sheet between
the parties dated August 23, 2004.
24.7 All amendments and modifications of this Agreement shall be in writing
and executed by both parties.
24.8 Each party will obtain any government approval required in its country
of domicile to enable this Agreement to become effective, or to enable
any payment hereunder to be made, or any other obligation hereunder to
be observed or performed. Each party will keep the other informed of
progress in obtaining any such governmental approval and will
cooperate with the other party in any such efforts.
24.9 This Agreement is made subject to any restrictions concerning the
export of materials and technology from the United States which may be
imposed upon or related to either party to this Agreement from time to
time by the Government of the United States. Neither party will
export, directly or indirectly, any Proprietary Information,
Intellectual Property, or Product(s) or other materials utilizing such
technology to any countries for which the United States Government or
any agency thereof at the time of export requires an export license or
other governmental approval, without first obtaining the written
consent to do so from the Department of Commerce or other agency of
the United States Government when required by applicable statute or
regulation.
24.10 This Agreement may be assigned by either party only with the prior
written consent of the other party, which consent will not be
unreasonably withheld, and provided the assignee agrees to perform
fully all of the responsibilities and obligations of the assignor
hereunder. Any purported assignment in contravention of this Section
24.10 shall, at the option of the non-assigning party, be null and
void and of no effect. No assignment shall release either party from
responsibility for performance of any accrued obligation of such party
hereunder.
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24.11 This Agreement shall be binding upon and inure to the benefit of the
parties, their respective officers and directors, and the permitted
assignees of either party.
24.12 This Agreement may be executed in any number of counterparts, each of
which will be deemed to be an original, and all of which together
shall be deemed to be one and the same instrument. Further, telefax
signatures shall be binding.
24.13 Nothing contained herein shall be deemed to create an agency, joint
venture, amalgamation, partnership or similar relationship between DMI
and COGENCO.
24.14 This Agreement does not confer, and shall not be construed as
conferring, on either party, or any other entity, any proprietary
right or license in or to the other party's Proprietary Information or
Intellectual Property, except as expressly provided in this Agreement.
24.15 Ambiguities, if any, in this Agreement shall not be construed against
any party, irrespective of which party may be deemed to have authored
the ambiguous provision.
24.16 The Article headings are for convenience only and will not be deemed
to affect in any way the language of the provisions to which they
refer.
IN WITNESS HEREOF, each party hereto acknowledges that the representative
named below has authority to execute this Agreement on behalf of the respective
party to form a legally binding contract and has caused this Agreement to be
duly executed on its behalf.
DMI BioSciences, Inc. Cogenco International, Inc.
By: ___________________________ By: ___________________________
Name: Xxxxx X. Xxxxxx Name: Xxxxx X. Xxxxxxx
Title: President and CEO Title: President
37
