Exhibit 10.1
LICENSE AND CO-MARKETING AGREEMENT
This Agreement, effective on April 12, 2005 ("Effective Date"), is by
and between Symbollon Pharmaceuticals, Inc., having a place of business at 00
Xxxxxx Xxxxx, Xxxxxxxxxx, XX 00000, and its Affiliates (collectively referred to
herein as "SP") and Bioaccelerate Holdings, Inc., having a place of business at
000 Xxxxx Xxxxxx, Xxx Xxxx, XX, 00000, and its Affiliates (collectively referred
to herein as "BIOACCELERATE").
WHEREAS, SP owns Intellectual Property relating to the use of IOGEN for
the treatment of cyclic mastalgia in humans;
WHEREAS, BIOACCELERATE and SP want to develop and commercialize IOGEN
for the treatment of cyclic mastalgia in humans; and
WHEREAS, BIOACCELERATE has financial resources, expertise and strategic
relationships which may facilitate the development and commercialization of the
product comprising or utilizing IOGEN for the treatment of cyclic mastalgia in
humans;
NOW THEREFORE, in consideration of the foregoing and the mutual
covenants 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, is controlled by SP or BIOACCELERATE.
For the purposes of this Agreement, "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 "BIOACCELERATE" means Bioaccelerate Holdings, Inc. and its Affiliates.
BIOACCELERATE is also referred to herein as a "party". Collectively,
SP and BIOACCELERATE are sometimes referred as the "parties".
1.3 "Calendar Quarter" means each three (3)-month period ending on the
last day of March, June, September and December of a given year.
1.4 "Clinical Trials" means all human clinical trials conducted with the
Product, including Phase 1 through Phase 4 human clinical trials.
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1.5 "Clinical Trials Plan" means a Clinical Trials Plan prepared and
amended from time to time by the Steering Committee as described in
Article 9. Each Clinical Trials Plan will be a comprehensive plan for
performing all research and development, Preclinical Studies and
Clinical Trials necessary to obtain Regulatory Approval of the Product
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.
1.6 "Commercially Reasonable And Diligent Efforts" means, with respect to
research, development and commercialization of the 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.
1.7 "Commercialization Plan" means a Commercialization Plan prepared and
amended from time to time by the Steering Committee as described in
Article 9. Each Commercialization Plan will be a comprehensive plan
for the commercialization of the Product 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 the Product that has received Regulatory
Approval), marketing plans, descriptions of promotional activities,
sales objectives, branding strategies, and all other relevant
information.
1.8 "Co-Promotion Rights" means the right of SP to co-promote the offer
for sale of the Product for the Field within the Territory through
SP's own sales force in partnership with BIOACCELERATE and not
directly or indirectly through sales, marketing, or license or
sub-license arrangements with any Third Party whatsoever; provided,
that Co-Promotion Rights shall only be exercised in coordination with
BIOACCELERATE so as not to disrupt the overall marketing, sales and
other commercialization efforts under this Agreement.
1.9 "Deductible Expenses" for the Product are [denotes redacted
confidential information for which confidentiality treatment is being
requested pursuant to Rule 24b-2]. All Deductible Expenses shall be
determined in accordance with generally accepted accounting principles
applied consistently and in accordance with the parties' practices.
"Deductible Expenses" do not include the costs of [denotes redacted
confidential information for which confidentiality treatment is being
requested pursuant to Rule 24b-2].
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1.10 "Drug Approval Application" means an application for Regulatory
Approval required for commercial sales of the Product, such as an NDA.
1.11 "Effective Date" is the date first written above.
1.12 "FDA" means the United States Food and Drug Administration.
1.13 "Field" means the use of the Product to treat cyclic mastalgia in
humans, which includes the anticipated indication for the treatment of
moderate or severe, periodic breast pain associated with symptomatic
fibrocystic breast disease.
1.14 "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.
1.15 "GCP" means the E6 Guideline for Good Clinical Practice of the ICH.
1.16 "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.
1.17 "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.
1.18 "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 the Product.
1.19 "ICH" means International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use.
1.20 "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.
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1.21 "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 the Product is
indicated, as would be identified in the Product's label under
applicable FDA or other applicable regulations or the foreign
equivalent thereof.
1.22 "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.
1.23 "Major Market Countries" means United States, Canada, France, Germany,
Italy, Spain, United Kingdom and Japan.
1.24 "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 the Product in the United
States or any similar filing with a regulatory authority of another
country to market any Product in that country.
1.25 "Phase 1 Trial" means a human clinical trial in any country that
is conducted to initially evaluate the safety and/or
pharmacological effect of the 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.
1.26 "Phase 2 Trial" means a human clinical trial in any country that is
conducted to initially evaluate the effectiveness of the 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.
1.27 "Phase 2a Trial" means a limited Phase 2 Trial typically conducted in
up to 50 patients to demonstrate the effectiveness of the Product for
a human Indication.
1.28 "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 the 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.
1.29 "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 the 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.
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1.30 "Phase 4 Trial" means a human clinical trial in any country initiated
after Regulatory Approval in that country within the approved product
labeling.
1.31 "Preclinical Studies" means, with respect to the Product, (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) limited toxicology data, and (vii) similar studies that are
typically performed before first administration of the Product to
humans.
1.32 "Prime Rate" means that prime interest rate specified in the Wall
Street Journal, New York Edition, for the date specified.
1.33 "Product" means product(s) comprising or utilizing IOGEN which are
used for treatment of cyclic mastalgia in humans.
1.34 "Profits" means Gross Sales Amount for the Product less all Deductible
Expenses for the Product.
1.35 "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,
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.
1.36 "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 the Product in that country or region, including
where applicable, approval of labeling, pricing, reimbursements and
manufacturing. "Regulatory Approval" in the United States for humans
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 humans 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.
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1.37 "Revenues" means (i) Profits and (ii) those payments received from
licensees and sublicensees of SP and/or BIOACCELERATE, including
licensing fees, sublicensing fees, milestone payments and royalties.
1.38 "Sales" means sales of each Product in the Territory by either party
(or either parties' assignees) to Third Parties in bona fide
arms-length transactions.
1.39 "SP" means Symbollon Pharmaceuticals, Inc. and its Affiliates. SP is
also referred to herein as a "party". Collectively, SP and
BIOACCELERATE are sometimes referred as the "parties".
1.40 "IOGEN" means a proprietary formulation for oral administration to
deliver molecular iodine.
1.41 "Steering Committee" means the Steering Committee described in Article
9.
1.42 "Territory" means the world.
1.43 "Third Party" means an entity other than SP or BIOACCELERATE. A Third
Party may be an individual, corporation, firm, partnership or other
entity.
1.44 "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 BIOACCELERATE shall be responsible for the costs of the development,
Regulatory Approval, and commercialization of the Product for the
Field within the Territory. SP shall cooperate with BIOACCELERATE and
provide reasonable technical support for the development of the
Product in accordance with Section 9 herein, with the goal of
obtaining Regulatory Approval for the Product 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 BIOACCELERATE's
first priority to adequately fund the development and
commercialization of the Product for the Field in the Territory.
Therefore, SP agrees, pursuant and subject to the terms of this
Agreement, to cooperate with, and provide reasonable technical support
for, BIOACCELERATE in developing the Product for humans, with the goal
of obtaining Regulatory Approval as soon as reasonably practicable for
the commercial marketing and sale of the Product.
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2.3 As specified in Article 8 below, SP and BIOACCELERATE shall share
equally the Revenues obtained as a result of the commercialization,
sales, licensing and sublicensing of the Product for the Field within
the Territory in accordance with the terms of this Agreement.
Article 3. SP's Responsibilities
3.1 SP shall perform its covenants and obligations as set forth throughout
this Agreement. In addition, SP, at inception, and thereafter from
time to time at the request of BIOACCELERATE, shall make available to
BIOACCELERATE all Intellectual Property pertaining to the Product,
including, without limitations, additions to the Intellectual Property
after the date of this Agreement (as to which SP shall furnish prompt
notice to BIOACCELERATE). In furnishing information to BIOACCELERATE
pursuant to this Section, and in furnishing technical assistance to
BIOACCELERATE pursuant to Section 4.5 of this Agreement, SP shall
furnish such information and technical assistance as BIOACCELERATE may
reasonably request; provided, that if doing so should require undue
expense or disruption of SP's business, BIOACCLERATE, at SP's request,
shall compensate reasonably SP for such undue expense or disruption.
It shall not be deemed unreasonable for SP to bear the cost of the
equivalent employee efforts of up to [denotes redacted confidential
information for which confidentiality treatment is being requested
pursuant to Rule 24b-2] in order to furnish information and technical
assistance to BIOACCELERATE pursuant to this Agreement without
requesting expense reimbursement from BIOACCELERATE.
Article 4. BIOACCELERATE's Responsibilities
4.1 Without limiting the generality of the foregoing, BIOACCELERATE shall
be responsible for all downstream development costs including Clinical
Trials and obtaining Regulatory Approval to market the Product in the
Field in the Territory, in accordance with the Clinical Trials Plan as
adopted and amended by the Steering Committee from time to time. The
Pre-clinical and Clinical Trials shall be conducted in accordance with
the Clinical Trials Plan for the Product as adopted and amended from
time to time by the Steering Committee.
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4.2 After Regulatory Approval of the Product, BIOACCELERATE shall be
responsible for commercializing the Product for the Field in at least
the Major Market Countries in accordance with the Commercialization
Plan for the Product as adopted and amended from time to time by the
Steering Committee. BIOACCELERATE shall also be responsible for
commercializing Product for which no Regulatory Approval is required
in accordance with the Commercialization Plan for the Product as
adopted and amended from time to time by the Steering Committee.
4.3 BIOACCELERATE shall be responsible for conducting Phase 4 Trials, if
required, for the Product in accordance with the Clinical Trials Plan
for the Product as adopted and amended from time to time by the
Steering Committee.
4.4 BIOACCELERATE shall be responsible for the cost of obtaining the
supply of the Product for any research and development, including
Preclinical Studies and Clinical Trials, in accordance with the
Clinical Trials Plan for the Product as adopted and amended from time
to time by the Steering Committee.
4.5 In addition to the specific task assigned to Symbollon in the Clinical
Trials Plan, SP shall provide other technical assistance to
BIOACCELERATE as BIOACCELERATE may request from time to time, subject
to the expense limitations set forth in Section 3.1.
Article 5. Obligations And Responsibilities Of Both Parties
5.1 BIOACCELERATE, and SP, to the extent it exercises its Co-Promotion
Rights, agree to use Commercially Reasonable And Diligent Efforts to
commercialize the Product for the Field within the Territory, with
priority being given to the commercialization of Product in the Major
Market Countries. Each party agrees to use Commercially Reasonable And
Diligent Efforts to perform its responsibilities under this Agreement
to research and develop the Product for the Field within the
Territory.
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, manufacturing,
Preclinical Studies, and Clinical Trials it performs and for Sales of
Product 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, including all data, results
and other information from any Clinical Trials.
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5.4 Each party shall xxxx the Product sold by it, and shall cause any
entity authorized by it to sell the Product to xxxx all Product 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 - Expenses
6.1 BIOACCELERATE shall be required to deposit funds into an escrow
account established jointly by the parties. As the cost are incurred
to execute the first part of the Initial US Clinical Trial Plan such
funds shall be drawn on to pay such expenses. Such funds shall be
deposited [denotes redacted confidential information for which
confidentiality treatment is being requested pursuant to Rule 24b-2].
6.2 After the completion of the first Phase 3 Trial for use of the Product
for the Field in the Territory, BIOACCELERATE shall be required to
deposit additional funds into the escrow account. As the cost are
incurred to execute the second part of the Initial US Clinical Trial
Plan, as such plan may be modified pursuant to Section 9.4, such funds
shall be drawn on to pay such expenses. Such funds shall be deposited
[denotes redacted confidential information for which confidentiality
treatment is being requested pursuant to Rule 24b-2].
6.3 The deposit and use of these particular expense amounts into the
escrow account shall not in any way limit BIOACCELERATE's
responsibility for payments of costs as set forth in Section 2.1 of
this Agreement.
Article 7. IP from Third Parties
7.1 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 SP and/or BIOACCELERATE 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 the Product for the Field in
the Territory.
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Article 8. Sharing Of Revenues; Reports And Records
8.1 BIOACCELERATE and SP will share [denotes redacted confidential
information for which confidentiality treatment is being requested
pursuant to Rule 24b-2] all Profits on Sales of the Product for the
Field in the Territory made by either one of them, or by the parties'
assignees. Payments of [denotes redacted confidential information for
which confidentiality treatment is being requested pursuant to Rule
24b-2] 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.
8.2 BIOACCELERATE and SP will share [denotes redacted confidential
information for which confidentiality treatment is being requested
pursuant to Rule 24b-2] all payments received from licensees and
sublicensees, including licensing fees, sublicensing fees, milestone
payments and royalties. Payments of [denotes redacted confidential
information for which confidentiality treatment is being requested
pursuant to Rule 24b-2] 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.
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 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 by country in the Territory during the reporting
period, (ii) dispositions of the Product other than by sale for cash,
(iii) calculation of Profits for each Product by country during the
reporting period, (iv) payments received from licensees and
sublicensees during the reporting period, including, for royalty
payments, a report from the licensees and/or sublicensees showing the
calculation of the royalties, (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.
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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 the Product, which records shall contain
all information necessary for the computation of Profits/royalties by
country and relating to payments received from licensees and
sublicensees. 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, royalties and licensee payments 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, royalties and licensee payments 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, royalties and licensee payments 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, royalties and licensee
payments calculations are correct or incorrect, the specific
details concerning any discrepancies, and the corrected amount of
Sales and/or Profits, royalties and licensee payments. No other
information will be provided to the requesting party.
(b) If the requesting party's independent accounting firm determines
that Profits, royalties and licensee payments 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,
royalties and licensee payments have been underpaid, the audited
party will pay the amount of the additional Profits, royalties
and licensee payments 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, royalties and licensee
payments 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.
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(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, royalties and licensee payments payable by
the audited party to the requesting party for such period exceed
5% of the Profits, royalties and licensee payments actually paid,
then the audited party will pay the reasonable fees and expenses
charged by such accounting firm.
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. Steering Committee
9.1 The parties hereby establish a Steering Committee to manage, direct,
supervise and coordinate, in accordance with the terms of this
Agreement, all of the activities contemplated by this Agreement,
including the development and commercialization of the Product for the
Field within the Territory. In particular, but without limitation, the
responsibilities of the Steering Committee will include:
(a) Preparation and approval of Clinical Trials Plans and
Commercialization Plans for the Product and modifications of
these plans as necessary or desirable, but no less than annually.
(b) Selection and approval of the Product for Clinical Trials.
(c) Approval of the protocols for all Clinical Trials and approval of
the Indication(s) for the Product 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 the Product's development and commercialization
(e.g., GLP, GCP, GMP, etc.).
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(e) Coordination of the manufacture and supply of the Product, the
regulatory filings, marketing, post-approval development studies
and all other activities necessary or desirable for the
development and commercialization of the Product.
(f) 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.
(g) Develop a publication strategy within the guidelines established
in Section 17.
(h) Establish sub-committees as appropriate to facilitate progress,
coordination and cooperation in key areas.
(i) Designate one of the parties or another entity to prepare and
maintain necessary budgets and other financial records.
(j) Establish the overhead amounts as provided in Section 1.9.
(k) Perform such other functions as appropriate to further the
purposes of this Agreement.
9.2 The Steering 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 Steering
Committee will be composed of two representatives of each party, but
the number of representatives may be any number subsequently agreed to
by the Steering Committee. The representatives will, preferably, be
individuals with expertise in basic research, pre-clinical research,
clinical research, manufacturing, regulatory filings, marketing and
post-approval development, as applicable to the stage of the
development or commercialization of the Product. Any member of the
Steering Committee may designate a substitute to attend and perform
the functions of the member at any meeting of the Steering Committee,
provided that prior notice is given to the other party. Each party
shall designate one of its representatives to be one of the
Co-Chairpersons of the Steering Committee. Within five (5) days after
the Effective Date, each party will notify the other of the identity
of its two initial representatives and of its Co-Chairperson.
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9.3 The Steering 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 Steering 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 Steering 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
of the members of the Steering Committee. Each party will alternately
be responsible for preparing and delivering to the members of the
Steering Committee, within thirty (30) days after the date of each
meeting, minutes of such meeting setting forth all decisions of the
Steering Committee and including a report on the progress of work
performed.
9.4 The Initial US Clinical Trials Plan has been developed and agreed to
by the parties. Within thirty (30) days after the Effective Date, the
Steering Committee will prepare a Clinical Trials Plan for the
Clinical Trials of, and other development work, if any, for the
Product for the Field within the Territory which will incorporate the
Initiate US Clinical Trials Plan. The Clinical Trials Plan will be
revised and amended at least annually. Each Clinical Trails Plan shall
identify which party shall be responsible for each specific task, and
to the extent that SP is designated to perform a task the parties
shall agree on reasonable compensation to be paid to SP for such
activity.
9.5 Within ninety (90) days after the Effective Date, the Steering
Committee will prepare a Commercialization Plan for the
commercialization of the Product for the Field within the Territory.
The Commercialization Plan will be revised and amended at least
annually.
9.6 The objective of the Steering Committee will be to reach agreement by
consensus on all matters. In the event that the representatives do not
reach consensus with respect to any matter, a vote will be taken. Each
member will have one vote. All major decisions about the development
and commercialization of the Product shall be made by majority vote.
In the event of a tie vote with respect to matters other than budgets,
the matter will be resolved as provided in Article 24.
Article 10. Regulatory Filings
10.1 Prior to Regulatory Approval, all submissions and regulatory filings
shall be made by, or on behalf of SP unless the Steering Committee
shall determine otherwise. Upon receipt of Regulatory Approval,
BIOACCELERATE shall own and maintain the Regulatory Approval, and SP
shall cooperate with BIOACCELERATE in facilitating the transfer to
BIOACCELERATE and to BIOACCELERATE's name, as may be requested by
BIOACCELERATE, of any submissions and regulatory filings theretofore
made as BIOACCELERATE may request. Prior to making any regulatory
submission, including IND or other Drug Approval Application, the
parties shall consult with each other regarding the scope and general
content of such submission. Both parties shall have the right to
review and modify on all submissions prior to filing in accordance
with specific time lines or other arrangements agreed upon by the
Steering Committee, and each parties' comments will be given all due
consideration.
14
10.2 Regulatory documents for each filing will be owned and centralized and
held at the offices of the party responsible for such filing, but will
be made available to the other party for use in accordance with this
Agreement at such other parties request. No party shall have the right
to transfer title or otherwise attempt in any manner to dispose of any
INDs or Drug Approval Applications or otherwise impair the other
party's rights in such INDs or Drug Approval Applications without the
written consent of the other party.
10.3 Each party, at its own expense, or initiation shall have the right to
obtain a copy of any regulatory filing, including INDs and other Drug
Approval Applications, from the owner, and each party shall have the
right of full access to, use of, reliance on and cross reference to
any regulatory document, the INDs and other Drug Approval Applications
of the other party for the purpose of conducting Clinical Trials and
seeking Regulatory Approvals.
10.4 Prior to Regulatory Approval, SP shall be responsible for conducting
meetings and discussions and routine telephone communications with the
regulatory authority related to the Clinical Trials. After Regulatory
Approval, the party owning and maintaining the Regulatory Approval
shall be responsible for conducting meetings and discussions and
routine telephone communications with the regulatory authority related
to the Clinical Trials. Each party may participate in all substantive
discussions and meetings with regulatory authorities and 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 a party's site and
facilities related to the Product, and each party 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. The party whose site or facilities
are being inspected shall consider the attendance of the other party
at the inspections, but shall not be obligated to accept the other
party's attendance at such inspections if such attendance would result
in the disclosure to other party of confidential information or trade
secrets unrelated to the Product.
10.6 To the extent either party receives written or material oral
communications from a regulatory authority relating to the Product or
a Clinical Trial, the party receiving such communication shall notify
the other party and provide a copy of any written communication as
soon as reasonably practicable.
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10.7 SP 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 the Product, the party that owns the
Regulatory Approval shall 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. Each party shall immediately inform the other of
any adverse drug reactions of which it becomes aware.
Article 11. Intellectual Property
11.1 As of the Effective Date, SP is the sole and exclusive owner of
Intellectual Property covering or relating to the use of IoGen treat
cyclic mastalgia in humans, including the patents and patent
applications listed in Appendix A attached hereto. SP shall remain the
owner of this Intellectual Property.
11.2 SP shall also be the sole and exclusive owner of all Intellectual
Property concerning or relating to (i) IOGEN and/or (ii) Product (s),
in either case, for the Field, which is conceived, created,
discovered, produced or developed by either party and/or by assignees,
licensees, sublicensees, consultants and/or Third Party contractors of
either party or both parties during the term of this Agreement;
provided, that SP shall license such Intellectual Property to such
other party, person or entity for use for the purposes of this
Agreement for the term of this Agreement in accordance with this
Agreement.
11.3 BIOACCELERATE agrees to make prompt written disclosure to SP of all
Intellectual Property concerning or relating to (i) IOGEN and/or (ii)
Product (s), in either case, for the Field, which is conceived,
created, discovered, produced or developed by it, its sublicensees,
its consultants and/or its Third Party contractors during the term of
this Agreement.
11.4 BIOACCELERATE agrees to require its sublicensees, consultants and
Third Party contractors to assign to SP all Intellectual Property
concerning or relating to (i) IOGEN and/or (ii) Product(s), in either
case, for the Field, which is conceived, created, discovered, produced
or developed by any of them during the term of the sublicense,
consultant's agreement or Third Party contract; provided, that SP
shall license such Intellectual Property to such other party, person
or entity for use for the purposes of this Agreement for the term of
this Agreement in accordance with this Agreement.
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11.5 BIOACCELERATE agrees to, and does hereby, assign to SP all of its
right, title and interest in and to all Intellectual Property
concerning or relating to (i) IOGEN and/or (ii) Product, in either
case, for the Field, which is conceived, created, discovered, produced
or developed by it, its sublicensees, consultants and/or its Third
Party contractors during the term of this Agreement; provided, that SP
shall license such Intellectual Property to such other party, person
or entity for use for the purposes of this Agreement for the term of
this Agreement in accordance with this Agreement.
11.6 BIOACCELERATE will assist SP, at SP'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 SP which concerns or relates to (i) IOGEN and/or (iii)
Product (s), in either case, for the Field, which is conceived,
created, discovered, produced or developed by it, its sublicensees,
consultants and/or its Third Party contractors during the term of this
Agreement. To that end, BIOACCELERATE 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 SP 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 SP is provided for
herein, execute, verify and deliver assignments of such
proprietary rights to SP or its designee.
(c) In the event SP is unable for any reason, after reasonable
effort, to secure BIOACCELERATE's signature on any document
needed in connection with the actions specified in this Article
11, BIOACCELERATE hereby irrevocably designates and appoints SP
and its duly authorized officers and agents as its agent and
attorney-in-fact, to act for and on BIOACCELERATE'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
BIOACCELERATE.
11.7 SP will take all necessary steps to obtain and maintain protection for
Intellectual Property covering or relating to IOGEN and Product(s) for
the Field, and SP shall be responsible for, and shall bear all the
costs of, obtaining and maintaining protection for such Intellectual
Property.
11.8 SP shall keep BIOACCELERATE advised as to all developments and shall
provide BIOACCELERATE with all materials sufficiently in advance to
allow BIOACCELERATE 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 SP. Notwithstanding the
foregoing, SP 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 SP shall notify BIOACCELERATE
as soon as possible after taking any such action.
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11.9 SP will abandon Intellectual Property relating to Product, or any
rights therein, only after notice to BIOACCELERATE at least thirty
(30) days in advance and only after giving BIOACCELERATE an
opportunity to assume responsibility for obtaining and/or maintaining
the Intellectual Property protection proposed to be abandoned and,
thereby, acquire all rights in such Intellectual Property.
Article 12. License Grant to BIOACCELERATE
12.1 SP hereby grants to BIOACCELERATE an exclusive license of all
Intellectual Property now or hereafter owned or licensed by it
concerning or relating to Product to research, develop, test, make,
have made, manufacture, use, sell, offer for sale, market,
commercialize, import and export the Product to the extent necessary
for BIOACCELERATE to perform its responsibilities and obligations and
exercise BIOACCELERATE's rights in connection with the research,
development, test, manufacture, use, sale, offer for sale, marketing,
commercialization, importing and exporting of the Product for the
Field within the Territory pursuant to the terms of this Agreement.
The licensed Intellectual Property includes, without limitation,
Symbollon's rights in and under the patents and patent applications
applicable to the Field and one or more valid claims of which cover
the Product or method of using or manufacturing the Product, including
the patents and patent applications listed in Appendix A attached
hereto, all nonprovisional, foreign and PCT applications corresponding
to them, all divisions, continuations, continuations-in-part, and
substitutions of any such nonprovisional applications, any foreign
national patent applications corresponding to any such PCT
application, any patents issuing from any of these patent applications
anywhere in the world, any extensions or reissues of such patents, and
the inventions described in any and all such patent applications and
patents. Notwithstanding the foregoing, SP reserves for itself the
Co-Promotion Rights set forth in Section 13.2 of this Agreement.
12.2 BIOACCELERATE shall have the right to assign, transfer or otherwise
dispose of any or all of its rights hereunder to Third Parties,
subject to SP approval, which approval shall not be unreasonably
withheld, for all or part of the Field in all or part of the
Territory, provided the assignee agrees to assume all of
BIOACCELERATE's obligations and responsibilities under this Agreement
in all, or the assignee's part, of the Field and Territory, as
applicable. The parties acknowledge and agree that notwithstanding the
foregoing, BIOACCELERATE may make any such assignment to any Affiliate
of BIOACCELERATE, as well as to any entity which is at least 25% owned
by BIOACCELERATE (and as to which no other person or entity has a
larger percentage of share ownership) without any such approval.
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Article 13. Retention Of Rights By SP
13.1 SP retains all rights in its Intellectual Property not expressly
granted to BIOACCELERATE in Article 12.
13.2 In addition, SP shall have Co-Promotion Rights for the Product for the
Field within the Territory, but no responsibility or obligation to
co-promote the Product. To the extent SP chooses to exercise its
Co-Promotion Rights in any particular country within the Territory, it
shall notify the Steering Committee. The Steering Committee shall be
responsible for coordinating the exercise of Co-Promotion Rights in a
manner consistent with the Commercialization Plan, including
determination of the appropriate cost sharing of SP's Deductible
Expenses incurred in exercise of its Co-Promotional Rights.
13.3 SP shall have the right to assign whatever Intellectual Property it
has not licensed to BIOACCELERATE pursuant to this Agreement to any
Third Parties.
13.4 SP shall have the right to assign, transfer or otherwise dispose of
any or all of its rights hereunder or any Intellectual Property it has
licensed to BIOACCELERATE pursuant to this Agreement to Third Parties,
subject to BIOACCELERATE approval, which approval shall not be
unreasonably withheld, for all or part of the Field in all or part of
the Territory, provided the assignee agrees to assume all of SP's
obligations and responsibilities under this Agreement in all, or the
assignee's part, of the Field and Territory, as applicable. Provided
that any such assignment, transfer or other disposition shall be
subject to the exclusive license of BIOACCELERATE pursuant to Section
12.1 of this Agreement and shall in no way diminish, limit or change
the scope, exclusivity or terms of BIOACCELERATE's exclusive license
pursuant to Section 12.1 of this Agreement, In connection with any
consideration by BIOACCELERATE of whether to approve any such
assignment, transfer or other disposition prior to the first filing
for Regulatory Approval, SP acknowledges that the active participation
of SP and its current officers in performing this Agreement was deemed
by BIOACCELERATE to constitute an important element of the
consideration for BIOACCELERATE to execute and perform this Agreement
and the implementation of the transactions contemplated hereby.
Article 14. Licenses And Sublicenses Of Third Parties
14.1 SP shall have the right to license its rights hereunder or any
Intellectual Property it has licensed to BIOACCELERATE pursuant to
this Agreement to Third Parties in all or part of the Territory with
the approval of BIOACCELERATE.
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14.2 BIOACCELERATE shall have the right to license its rights hereunder to
Third Parties in all or part of the Territory with the approval of
SP..
14.3 The parties agree to present any prospective license or sublicense
arrangements to the Steering Committee for review and comment by the
Steering Committee.
Article 15. Third-Party Contractors
15.1 The parties may individually or jointly enter into written contracts
with Third Parties to perform activities required of them 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.
15.2 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.
15.3 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 16.
15.4 All Third Party contractors must further agree to assign any
Intellectual Property concerning or relating to (i) IOGEN and/or (ii)
Product (s), in either case, for the Field, conceived, created,
discovered, produced or developed as a result of the Third Party's
performance under the contract to SP provided, that SP shall license
such Intellectual Property back to each such applicable Third Party
for performance by such Third Party contractor of its responsibilities
in connection with the transactions contemplated by this Agreement.
15.5 All Third Party contracts for the performance of Preclinical Studies
or Clinical Trials must be approved in advance by the Steering
Committee.
15.6 Third Party contracts are distinguished herein from licenses and
sublicenses because no payments are made by the Third Party
contractors to SP and/or BIOACCELERATE pursuant to the terms of a
Third Party contract.
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Article 16. Confidentiality
16.1 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.
16.2 As of the Effective Date, this Agreement supersedes the
confidentiality agreement between the parties dated on or about
October 27, 2004, but only insofar as such confidentiality agreement
relates to the subject matter of this Agreement. All Proprietary
Information exchanged between the parties under such confidentiality
agreement relating to the subject matter of this Agreement shall be
deemed Proprietary Information hereunder and shall be subject to the
terms of this Agreement.
16.3 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.
16.4 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;
21
(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 17. Publicity, Publications and Presentations
17.1 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,
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
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 the Product. The principles to be
observed in such public disclosures will be accuracy, the
confidentiality requirements of Article 16, compliance with regulatory
agency regulations and guidelines, the advantage a competitor may gain
from any public statements under this Subsection 17.1, and the
standards and customs in the pharmaceutical industry for such
disclosures by companies comparable to SP and BIOACCELERATE.
17.2 SP and BIOACCELERATE 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. Both parties also recognize their mutual interest in
obtaining valid patent rights for any inventions concerning or
relating to IOGEN and/or the Product and in protecting the
confidentiality of their Proprietary Information.
22
(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 Steering Committee with
a draft manuscript of the proposed publication or presentation.
(b) The nonpublishing/nonpresenting party and the Steering 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 Steering 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 Steering Committee received within the
thirty-day review period.
(e) If the Steering 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 Steering Committee pursuant to Section 9.1, then the
publishing/presenting party and the Steering 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 Steering Committee about
the proposed modifications or delays cannot be reached within
thirty days after receipt of the written objection.
(f) Finally, in the event that the nonpublishing/nonpresenting party
or the Steering Committee determines that the manuscript
describes patentable subject matter, the
nonpublishing/nonpresenting party and/or the Steering 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, or until such time as required by
SP to obtain all necessary assignments and to file a patent
application covering the patentable subject matter.
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Article 18. Representations, Warranties And Disclaimer
18.1 SP 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.
18.2 SP represents and warrants that it is the sole and exclusive owner of
the patents and patent applications listed in Appendix A.
18.3 SP further represents and warrants that it has the full right and
authority to grant BIOACCELERATE all of the rights granted hereunder.
18.4 BIOACCELERATE 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.
18.5 EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 17 OR ELSEWHERE IN THIS
AGREEMENT, SP 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
BIOACCELERATE HEREUNDER. SPECIFICALLY, WITHOUT LIMITING THE GENERALITY
OF THE FOREGOING, SP 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. SP DOES NOT WARRANT THE ACCURACY OF ANY 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.
24
Article 19. Defense Of Third-Party Claims
19.1 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.
19.2 Notwithstanding the foregoing, a party seeking indemnification from
the other party must proceed as provided in the indemnification
provisions of Article 21.
Article 20. Infringement Or Misappropriation By Third Parties
20.1 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 SP.
25
20.2 SP shall have the first option to proceed against such Third Party.
BIOACCELERATE 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
SP in proceeding against the Third Party. All costs, expenses and
disbursements of proceeding against such Third Party shall be borne by
SP, including reimbursement of expenses incurred by BIOACCELERATE as a
result of assisting SP in proceeding against the Third Party. SP shall
keep BIOACCELERATE fully informed of all such proceedings. SP shall
not settle any such proceeding without the input of BIOACCELERATE,
which input will be considered in good faith. In the event that SP is
successful in proceeding against the Third Party, all monies recovered
by SP for infringement or misappropriation by way of settlement or
order of court shall be treated as follows. If it has not already done
so, SP shall deduct and reimburse BIOACCELERATE the attorneys' fees,
disbursements and costs expended by BIOACCELERATE in the conduct of
proceeding against the Third Party. Next, SP shall deduct and retain
the attorneys' fees, disbursements and costs expended by SP in the
conduct of proceeding against the Third Party. Any monies remaining
after such deduction shall be divided as follows: 75% to SP and 25% to
BIOACCELERATE.
20.3 In the event that SP elects not to proceed, BIOACCELERATE shall have
the right to proceed against the Third Party. SP 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 BIOACCELERATE in proceeding against
the Third Party. All costs, expenses and disbursements of proceeding
against such Third Party shall be borne by BIOACCELERATE, including
reimbursement of expenses incurred by SP as a result of assisting
BIOACCELERATE in proceeding against the Third Party. BIOACCELERATE
shall keep SP fully informed of all such proceedings. BIOACCELERATE
shall not settle any such proceeding without the input of SP, which
input will be considered in good faith. In the event that
BIOACCELERATE is successful in proceeding against the Third Party, all
monies recovered by BIOACCELERATE for infringement or misappropriation
by way of settlement or order of court shall be treated as follows. If
it has not already done so, BIOACCELERATE shall deduct and reimburse
SP the attorneys' fees, disbursements and costs expended by SP in the
conduct of proceeding against the Third Party. Next, BIOACCELERATE
shall deduct and retain the attorneys' fees, disbursements and costs
expended by BIOACCELERATE in the conduct of proceeding against the
Third Party. Any monies remaining after such deduction shall be
divided as follows: 75% to BIOACCELERATE and 25% to SP.
Article 21. Indemnification
21.1 BIOACCELERATE hereby agrees to indemnify, defend and hold harmless SP,
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 BIOACCELERATE, except to the extent that
such Damages arise out of, are based upon or result from (i) a
material breach of the Agreement by SP or (ii) the negligence or
willful misconduct of SP.
26
21.2 SP hereby agrees to indemnify, defend and hold harmless BIOACCELERATE,
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 SP, except to the extent that such Damages arise out of,
are based upon or result from (i) a material breach of the Agreement
by BIOACCELERATE or (ii) the negligence or willful misconduct of
BIOACCELERATE.
21.3 BIOACCELERATE hereby agrees to indemnify, defend and hold harmless SP,
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 BIOACCELERATE, except to the extent that such Damages
arise out of, are based upon or result from (i) a material breach of
the Agreement by SP or (ii) the negligence or willful misconduct of
SP.
21.4 SP hereby agrees to indemnify, defend and hold harmless BIOACCELERATE,
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 SP, except to the extent that such Damages arise out of,
are based upon or result from (i) a material breach of the Agreement
by BIOACCELERATE or (ii) the negligence or willful misconduct of
BIOACCELERATE.
21.5 A party entitled to indemnification under this Article 21 (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.
21.6 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.
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21.7 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 21 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.
21.8 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 21.5 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 22. Insurance
22.1 Each party to this Agreement will obtain and maintain (i) general
liability insurance in comprehensive form in an appropriate amount,
which shall cover no less than the following risks: bodily injury,
personal injury, liability, property damage and products liability,
and (ii) such other types of insurance considered to be reasonable and
prudent given the types of risks involved in research, development,
pre-commercialization and commercialization of pharmaceuticals, and
the liability limits on any such insurance shall be reasonable for the
risks involved; provided, that SP shall not be required to maintain
such insurance for so long as BIOACCELERATE is the exclusive licensee
of the Product and SP is not exercising Co-Promotion Rights under this
Agreement. Each party shall obtain and maintain such coverage with
Third Party commercial insurance carriers rated "A" or better. Each
party to this Agreement shall inform the other party in writing of any
material change in coverage provided by such policies.
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Article 23. Term and Termination
23.1 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 the Product 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. In addition, BIOACCELERATE, at its sole
election, may terminate this Agreement upon the expiration of the
latest to expire of the Patents listed on Appendix A to this
Agreement.
23.2 The parties may at any time terminate this Agreement, in part or in
its entirety, by mutual written agreement.
23.3 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.
23.4 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:
(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;
29
(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.
23.5 Upon termination of this Agreement for any reason:
(a) All rights and licenses granted to BIOACCELERATE hereunder shall
revert to SP, except that BIOACCELERATE shall have the right to
sell the Product in inventory as provided in Subsection (b) of
this Section 23.5.
(b) BIOACCELERATE shall cease all activities with respect to the
Product, including all making or manufacturing (by BIOACCELERATE
and/or by Third Parties for BIOACCELERATE), using, selling,
offering for sale, marketing, commercializing, importing and
exporting of the Product. Notwithstanding the foregoing,
BIOACCELERATE shall have the right to sell the Product in
inventory at prices of its choosing, provided that SP shall have
a right of first refusal to purchase the Product in inventory at
such prices and provided BIOACCELERATE makes the payments and
reports required by Article 7.
(c) If requested by SP, BIOACCELERATE shall (i) remain responsible to
supply the amounts of the Product it was obligated to supply at
the time of such termination for a reasonable period of time, not
to exceed six (6) months from the date of termination, to allow
SP to find an alternate source of supply, (ii) make its personnel
and other resources reasonably available to SP 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, and (iii) provide and assign to SP all clinical
data, INDs, Drug Approval Applications, Regulatory Approvals, and
all other regulatory documentation covering the Product that
BIOACCELERATE may have developed in its activities under this
Agreement. If termination of the Agreement occurred because of a
breach by BIOACCELERATE, then BIOACCELERATE will be responsible
for all of the costs of performing these obligations. If
termination of the Agreement occurred because of a breach by SP,
then SP will be responsible for all of the costs of performing
these obligations. Otherwise, the parties will share the costs.
30
(d) BIOACCELERATE's sublicense(s) of its rights pursuant to Section
14.3 above (referred to herein as "Article 14 Sublicense(s)")
shall be transferred to SP. The Article 14 Sublicense(s) will
remain in full force and effect so long as the sublicensee(s)
perform(s) the obligations of the Article 14 Sublicense(s), and
SP shall have all of the rights and benefits of the Article 14
Sublicense(s) (including the right to receive 100% of all
payments due under the Article 14 Sublicense(s)) and shall be
responsible for performing all of the obligations required of
BIOACCELERATE by the Article 14 Sublicense(s). BIOACCELERATE will
execute such documents as may be requested by SP to attest to the
transfer to SP of all of its Article 14 Sublicense(s).
26.6 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 24. Dispute Resolution
24.1 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 Steering Committee.
24.2 Failing resolution by the Steering Committee of any controversy or
claim within thirty (30) days after such referral, the matter shall be
referred to the Chief Executive Officers of the parties. Any
controversy or claim arising in the Steering Committee or any matter
about which the Steering Committee is deadlocked shall also be
referred to the Chief Executive Officers of the parties.
24.3 The Chief Executive Officers of the parties 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 Chief Executive Officers of the
parties, either party shall be free to notify the Chief Executive
Officers of the parties that it wishes the matter to be referred to
non-binding mediation.
24.4 The non-binding mediation will proceed as follows. The controversy or
claim shall be presented to a single mediator. The single mediator
shall be chosen by the Chief Executive Officers of the parties within
ten (10) days after receiving the notification specified in Subsection
24.3. The single mediator shall be an individual with experience and
qualifications suitable to the controversy or claim in dispute. If the
Chief Executive Officers of the parties cannot agree on a single
mediator, they shall each appoint a mediator within ten (10) days
after receiving the notification specified in Subsection 24.3, and
these two mediators shall chose the single mediator within ten (10)
days after being appointed. The single mediator will conduct a hearing
within thirty (30) days after being chosen. The hearing will be held
at a time and place agreed to between the parties and the mediator and
will last no longer than eight (8) hours. At the hearing, each party
will each have no more than four (4) hours to present evidence,
witnesses and arguments, to present a proposed remedy, and to answer
the questions of the mediator. Copies of all documents to be relied on
by a party shall be provided to the mediator and the other party at
least three (3) business days prior to the hearing. The mediator will
notify the parties of his/her non-binding decision no later than three
(3) business days after the hearing.
31
24.5 If either party elects not to accept the non-binding decision of the
mediator, that party shall be free to initiate legal proceedings in a
court of competent jurisdiction in New York.
24.6 This Agreement shall be governed by, and its provisions construed and
enforced in accordance with, the law of the State of New York. Both
parties agree to submit to the jurisdiction of all New York 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 New York.
Article 25. Miscellaneous
25.1 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 SP: Symbollon Pharmaceuticals Inc.
00 Xxxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Attention: Xx. Xxxx Xxxxxxxxx
If to BIOACCELERATE: Bioaccelerate Holdings, Inc.
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xx. Xxx Xxxx
32
25.2 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 Force Majeure, including, without limitation, 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.
25.3 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.
25.4 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.
25.5 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.
25.6 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 confidentiality
agreement between the parties dated on or about October 27, 2004, in
part, as provided in Subsection 16.2 hereof.
25.7 All amendments and modifications of this Agreement shall be in writing
and executed by both parties.
25.8 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 the Product 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.
33
25.9 This Agreement may be assigned by either party only pursuant to
Sections 12.2 and 13.4 of this Agreement, as applicable. Any purported
assignment in contravention of this Section 25.9 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.
25.10This 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.
25.11This 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.
25.12Nothing contained herein shall be deemed to create an agency, joint
venture, amalgamation, partnership or similar relationship between SP
and BIOACCELERATE.
25.13This 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.
25.14Ambiguities, 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.
25.15The 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.
34
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.
Symbollon Pharmaceuticals Inc. Bioaccelerate Holdings, Inc.
By: /s/ Xxxx Xxxxxxxxx By: /s/ Xxx Xxxx
------------------------ ----------------------
Name: Xxxx Xxxxxxxxx Name: Xxx Xxxx
Title: President Title: President and CEO
Date: April 12, 2005 Date: April 12, 0000
00
Xxxxxxxx X
Xxxxxxx xx Xxxxxx Xxxxxx Patents and Patent Applications
[Contents of Appendix A redacted as confidential information for which
confidential treatment is being requested pursuant to Rule 24b-2.]
36
