EXHIBIT 10.30 A
LICENSE, DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
THIS LICENSE,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the
“Agreement”) is made effective as of the 2nd day of
March, 2000 (the “Effective Date”) by and between
GUILFORD PHARMACEUTICALS INC., a Delaware corporation having its
principal place of business at 6611 Tributary St., Baltimore,
Maryland, U.S.A. 21224 (“Guilford”), on the one hand,
PROQUEST PHARMACEUTICALS INC., a Kansas corporation having an
address at 4913 Stoneback Place, Lawrence, Kansas 66047
(“ProQuest”). Guilford and ProQuest are sometimes
referred to herein individually as a “Party” and
collectively as the “Parties”. References to Guilford
and ProQuest shall include their respective Affiliates, as defined
herein.
RECITALS
1. Pursuant
to a License Agreement, dated April 2, 1999 (the “KU
License”), between ProQuest and the University of Kansas
Center for Research, Inc. (“KUCR”), ProQuest holds
certain rights with respect to a proprietary compound, PQ-1002, as
further described in the attached Schedule 1
(“PQ-1002”), and related intellectual property as
further described in the attached Schedule 2, which it is
using to develop a pro-drug of propofol, currently marketed for use
as an anesthetic.
2. Guilford
possesses research, development and commercialization capabilities
sufficient to perform the activities contemplated in this
Agreement.
3. The
Parties desire to enter into this Agreement pursuant to which
(a) ProQuest shall grant to Guilford an exclusive license to
PQ-1002 and certain related compounds; and (b) Guilford agrees
to develop and commercialize such products, all on the terms and
conditions of this Agreement.
NOW, THEREFORE, in
consideration of the foregoing and of the mutual covenants and
agreements hereinafter set forth, the parties hereto agree as
follows:
ARTICLE 1. DEFINITIONS
The following capitalized terms
shall have the following meanings as used in this
Agreement:
1.1 “Act” shall mean the U.S. Food, Drug and
Cosmetic Act, as amended, and the regulations promulgated
thereunder.
1.2 “Affiliate” shall mean a Person that,
directly or indirectly, through one or more intermediates,
controls, is controlled by, or is under common control with the
Person specified.
1.3 “Agreement Compound” shall mean
(i) PQ-1002; (ii) any other compound in ProQuest’s
Control on the Effective Date or during the term of this Agreement
which is a prodrug of propofol or of a propofol analog; or
(iii) any other compound which Guilford (and/or a sublicensee
of Guilford’s rights under this Agreement) may derive from
ProQuest Patent Rights or ProQuest Know-how and that delivers
(A) the propofol nucleus; or (B) a propofol analog.
“Propofol analog” as used in this Agreement shall mean
any compound that is derived from or
similar to the propofol nucleus
and is intended or expected to have similar pharmacological
properties to propofol. “Propofol nucleus” as used in
this Agreement shall mean 2,6-di-isopropylphenol.
1.4 “Bankruptcy Event” shall mean, with respect
to a particular Party, that voluntary or involuntary proceedings by
or against such Party are instituted in bankruptcy or under any
insolvency law, or a receiver or custodian is appointed for such,
or proceedings are instituted by or against such Party for
corporate reorganization or the dissolution of such Party, which
proceedings, if involuntary, shall not have been dismissed within
sixty (60) days after the date of filing, or such Party makes
an assignment for the benefit of its creditors, or substantially
all of the assets of such Party are seized or attached and not
released within sixty (60) days thereafter.
1.5 “Commercialize” or
“Commercialization” shall mean those activities
relating to the promotion, marketing and sale of any Agreement
Compound.
1.6 “Commercially Reasonable Efforts” shall mean
efforts and resources commonly used in the research-based
pharmaceutical industry for a product at a similar stage in its
product life or similar market potential, taking into account
efficacy, the competitiveness of alternative products in the
marketplace, the degree of intellectual property protection
available for the product (whether to Guilford or to Third
Parties), the likelihood of regulatory approval given the
regulatory structure involved, the profitability of the product
including the royalties payable to licensors of Patent Rights,
alternative products and other relevant factors. Commercially
Reasonable Efforts shall be determined on a market-by-market basis
for a particular product, and it is anticipated that the level of
effort will change over time, reflecting changes in the status of
the product and the market involved. For the avoidance of doubt,
the Parties agree that Guilford (or its Affiliates or sublicensees)
may elect not to sell a Program Product in a particular country if
there is no patent covering same in such country.
1.7 “Confidential Information” shall mean with
respect to a particular Party, non-public proprietary data,
information and/or materials that are owned or licensed in whole or
in part by such Party (including, without limitation, the terms and
conditions of the KU License, and the proprietary business, patent
prosecution, process, technical information and data specified in
Section 6.01 of the KU License).
1.8 “Consent and Agreement” shall mean the
Consent and Agreement, dated as of even date hereof, as the same
may be amended from time to time, among Guilford, ProQuest and
KUCR, the form of which is attached hereto and made a part hereof
as Exhibit C .
1.9 “Controls” or “Controlled” shall
mean, with respect to intellectual property, possession of the
ability to grant licenses or sublicenses without violating the
terms of any agreement or other arrangement with, or the rights of,
any Third Party.
1.10 “Determination Date” shall mean the earlier
of (i) the date on or before sixty (60) days following
Guilford’s commencement of the Infusion Study contemplated in
Section 3.2, or (ii) the date that Guilford delivers
written notice to ProQuest and the Escrow Agent as set forth in
Section 5.2.
1.11 “Develop” or “Development”
shall mean those activities related to the clinical development of
an Agreement Compound including those activities related to the
obtainment of Regulatory Approvals for the clinical testing and
commercial sale of an Agreement Compound. Development activities
will specifically include (i) all activities relating to
toxicology, in vitro assays, animal models of clinical efficacy and
other studies required to support a Regulatory Filing to initiate
clinical testing of an Agreement Compound and (ii) all
activities relating to clinical studies and determination of safety
and efficacy of an Agreement Compound in humans to support a
Regulatory Filing to initiate Commercialization of an Agreement
Compound.
1.12 “Effective Date” shall mean the date of
this Agreement first above written.
1.13 “Escrow Agreement” shall mean the Escrow
Agreement, dated of even date hereof, as the same may be amended
from time to time, between Guilford and ProQuest, the form of which
is attached hereto and made a part hereof as Exhibit B
.
1.14 “Europe” or “European
Country” shall mean, for purposes of Sections 3.3,
5.3(c)(ii) and 8.6, any of the following countries: Austria,
Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
Luxembourg, Netherlands, Portugal, Spain, Sweden, Switzerland and
the United Kingdom.
1.15 “Exclusive Cooperation Field” shall mean
the Development of PQ-1002 or any other Agreement Compound, either
alone or in combination with any other compound, and irrespective
of indication, formulation, or other factors, but only in the field
of human pharmaceutical or veterinary applications.
1.16 “Exclusive License” shall mean an
exclusive, worldwide, royalty-bearing license, subject to the
University of Kansas’s retained rights under
Sections 2.03 and 2.04 of the KU License.
1.17 “FDA” shall mean the Federal Food and Drug
Administration of the United States Department of Health and Human
Services or any successor agency thereof.
1.18 “Force Majeure” shall mean any occurrence
beyond the reasonable control of a Party that prevents or
substantially interferes with the performance by the Party of any
of its obligations hereunder. Without limiting the generality of
the foregoing, any of the following: any act of God, flood, fire,
explosion, breakdown of plant, earthquake, strike, lockout, labor
dispute, casualty or accident, war, revolution, civil commotion,
acts of public enemies, blockage or embargo, injunction, law,
order, proclamation, regulation, ordinance, demand, regulatory
delay, or requirement of any government or of any subdivision,
authority or representative of any such government, inability to
procure or use materials, labor, equipment, transportation, or
energy sufficient to meet manufacturing needs without the necessity
of allocation, or clinical, technical, medical, scientific, or
manufacturing delays, or any other cause whatsoever, whether
similar or dissimilar to those above enumerated, provided
that in all such cases it is beyond the reasonable control
of such Party, shall constitute Force Majeure.
1.19 “Governance Committee” shall have the
meaning defined in Article 4.
1.20 “Guilford Know-how” shall mean any and all
of Guilford’s techniques and data, including, but not limited
to, the identity of and information relating to PQ-1002 or any
other Agreement Compound, inventions, practices, methods,
knowledge, skill, experience, test data including pharmacological,
toxicological, pharmacokinetic and clinical test data, analytical
and quality control data, marketing, pricing, distribution, cost,
sales, manufacturing, patent and legal data, assays and biological
materials relating to PQ-1002 or any other Agreement Compound, and
any other information reasonably necessary for Guilford to Develop
and Commercialize PQ-1002 or any other Agreement Compound and to
otherwise perform its obligations under this Agreement which
(i) Guilford discloses to ProQuest under this Agreement or
(ii) Guilford Controls on the Effective Date and/or during the
term of this Agreement. Guilford Know-how shall exclude Guilford
Patent Rights.
1.21 “Guilford Patent Rights” shall mean the
Patent Rights which cover a composition of matter, use, method,
process or other matter relating to any Agreement Compound or
Program Product, or derived from ProQuest Patent Rights or ProQuest
Know-how, which Patent Rights are Controlled by Guilford from and
after the Effective Date and during the term of this
Agreement.
1.22 “IND” shall mean an “Investigational
New Drug Application,” as defined in the Act, and all
supplements thereto, covering an Agreement Compound.
1.23 “License Field” shall mean the research,
Development or Commercialization or any other use (including
manufacture, marketing, sale or distribution), for profit or
not-for-profit, of any Agreement Compound, but only for human
pharmaceutical or veterinary applications.
1.24 “Milestones” or “Milestone
Payments” shall mean the payments to be made to ProQuest
by Guilford upon occurrence of certain events as set forth in
Article 5.
1.25 “NDA” shall mean a “New Drug
Application,” as defined in the Act, and all supplements
thereto, covering an Agreement Compound.
1.26 “Net Sales” shall mean gross sales revenues
from the sale or other supply of Program Products by Guilford, its
Affiliates, sublicensees or non-Affiliated distributors to
non-Affiliated Third Parties, less trade discounts (including
without limitation, cash discounts, prompt payment or volume
discounts, chargebacks from wholesalers, other allowances granted
to customers or wholesalers of products and payments to government
agencies, whether in cash or trade, rebates, retroactive price
reductions or allowances actually allowed or granted from the
billed amount), credits or allowances actually granted upon claims,
rejections or returns of Program Products (including pursuant to
recalls), and sales, value-added and other taxes actually paid
based on sales price (when included in gross sales), but not
including taxes when assessed on income derived from such sales. In
order to insure ProQuest the full royalty payments contemplated
hereunder, Guilford agrees that in the event any Program Product is
sold or otherwise transferred to an Affiliate or a sublicensee, or
to a corporation, firm or association with which Guilford has an
arrangement which could result in an artificial reduction in the
price paid by such party to Guilford for an Program Product (
e.g ., such purchaser has an option to purchase
Guilford’s stock, or has actual ownership of Guilford stock,
or an arrangement with Guilford involving division of profits or
special rebates or allowances respecting such Program Product)
(collectively, “Affiliated Purchasers”), the royalties
to be paid hereunder for such Program Product shall be based upon
the greater of: (1) the net selling price at which such
Affiliated Purchaser resells such Program Product to the end-user;
(2) the fair market value of the Program Product being sold at
that level of distribution; or (3) the net price paid by such
Affiliated Purchaser for Program Product. Notwithstanding anything
to the contrary in this Section 1.26, if a Program Product is
distributed or invoiced for a discounted price substantially lower
than customary in the trade or distributed at no cost to Affiliates
or otherwise for bona fide business, scientific or charitable
reasons (including without limitation in connection with clinical
trials, compassionate sales or an indigent program), Net Sales
shall be based on the actual price received (which may be a
discounted price, or even $0, if distributed free in such bona
fide cases). In the event that Guilford, its Affiliate or its
sublicensee sells a Program Product in combination with other
active ingredients or substance, the Net Sales for purposes of
royalty payments shall be based on the sales revenues received with
respect to the sales price of the component(s) consisting of such
Program Product, and if such active components are not priced
separately, based on such sales price as Guilford or its Affiliate
may reasonably allocate to the Program Product included in such
combination, subject to the reasonable approval of
ProQuest.
1.27 “Patent Rights” shall mean all patents and
patent applications and foreign counterparts thereof, in all cases
in any jurisdiction in the world, including any existing or future
extensions, registrations, confirmations, reissues, continuations,
divisions, substitutions, revalidations, continuations-in-part,
re-examinations or renewals of such patent or application,
including without limitation Supplementary Protection Certificates
or the equivalent thereof.
1.28 “Person” shall mean any individual, firm,
corporation, partnership, limited liability company, trust,
unincorporated organization or other entity or a government agency
or political subdivision thereto, and shall include any successor
(by merger or otherwise) of such Person.
1.29 “Program Patent Rights” shall mean any
ProQuest Patent Rights or Guilford Patent Rights, and includes any
Patent Rights, the subject of which is an invention conceived by
either Guilford or ProQuest, or by
Guilford and ProQuest jointly, or
by a Third Party on behalf of Guilford and/or ProQuest pursuant to
a contractual arrangement, either solely or jointly with Guilford
and/or ProQuest, during the term of this Agreement or a
12 month period thereafter, and related to PQ-1002 or any
other Agreement Compound.
1.30 “Program Product” shall mean a product, the
manufacture, use, sale, offer to sell or importation of which would
(but for a right granted or retained by KUCR, ProQuest, Guilford or
a sublicensee or other partner of Guilford) infringe one or more
claims of a valid, issued patent included in the Program Patent
Rights if any such activities were conducted in (i) the
country of sale, (ii) the United States, or (iii) each of
Germany, France and the United Kingdom.
1.31 “ProQuest Know-how” shall mean any and all
of ProQuest’s techniques, data and other information relating
to PQ-1002 or any other Agreement Compound (including, but not
limited to, the identity of and information relating to PQ-1002 or
any other Agreement Compound, inventions, practices, methods,
knowledge, skill, experience, test data including pharmacological,
toxicological, pharmacokinetic and clinical test data, analytical
and quality control data, marketing, pricing, distribution, cost,
sales, manufacturing, patent and legal data, assays and biological
materials, and any other information reasonably necessary for
Guilford to Develop and Commercialize PQ-1002 or any other
Agreement Compound), which ProQuest Controls on the Effective Date
and/or during the term of this Agreement. ProQuest Know-how shall
exclude ProQuest Patent Rights.
1.32 “ProQuest Patent Rights” shall mean Patent
Rights which cover a composition of matter, use, method, process or
other matter relating to PQ-1002 or any other Agreement Compound,
which is owned or Controlled by ProQuest as of the Effective Date
or during the term of this Agreement, including any joint interest
it may have from time to time in Program Patent Rights, including
without limitation the patent applications set forth on
Schedule 2 attached hereto.
1.33 “Regulatory Approval” shall mean any
approvals (including, where necessary for the marketing, use or
other distribution of a drug in a regulatory jurisdiction, pricing
and reimbursement approvals), licenses, registrations, or
authorizations or equivalents necessary for the manufacture, use,
storage, import, export, clinical testing, transport, marketing,
sale and distribution of a Program Product or Agreement Compound in
a regulatory jurisdiction anywhere in the world (including without
limitation authorization or authority to distribute a drug pursuant
to laws, regulations or other permission covering the distribution
of drugs on an orphan drug, named patient compassionate sale or
similar bases).
1.34 “Regulatory Filings” shall mean,
collectively, INDs, Biologics License Applications, Drug Master
Files, NDAs and/or any other comparable filings as may be required
by any federal, state or local regulatory agency, department,
bureau or other governmental entity, in order to obtain Regulatory
Approvals.
1.35 “Royalty” shall have the meaning defined in
Section 6.1 of this Agreement.
1.36 “Stock Purchase Agreement” shall mean the
Stock Purchase Agreement, dated as of even date herewith, as the
same may be amended from time to time, between Guilford and
ProQuest, the form of which is attached hereto and made a part
hereof as Exhibit A .
1.37 “Third Party” shall mean any Person other
than Guilford or ProQuest or their respective Affiliates, including
governmental agencies and bodies.
1.38 “Third Party Royalties” shall mean
royalties payable by Guilford, its Affiliates or sublicensees to a
non-Affiliate Third Party (or multiple non-Affiliate Third Parties)
to make, have made, use, sell, offer for sale or import Agreement
Compounds where the royalty payable to such non-Affiliate Third
Party is based on Patent Rights owned or Controlled by a Third
Party.
Capitalized terms
not defined in this Article 1 shall have the meaning ascribed
to them as set forth in this Agreement below.
ARTICLE 2. EXCLUSIVITY AND LICENSE
GRANT
2.1 Exclusivity. Subject to the terms and conditions of this
Agreement, each of Guilford and ProQuest agrees to work exclusively
with the other during the term of this Agreement in the Exclusive
Cooperation Field, and neither it nor any of its Affiliates will
directly or indirectly conduct, have conducted or fund any
research, development, regulatory, manufacturing or
commercialization activity within the Exclusive Cooperation Field,
except as otherwise agreed by the Parties or permitted in this
Agreement.
2.2 License Grant to Guilford. Subject to the terms and
conditions of this Agreement, ProQuest hereby grants to Guilford an
Exclusive License, including under the ProQuest Patent Rights, to
make, have made, use, sell, offer to sell and import PQ-1002, and
to the extent any license is necessary to engage in such
activities, any other Agreement Compound in the Licensed Field
(provided, however, that Guilford shall not be entitled to practice
its rights under this Agreement with respect to an Agreement
Compound other than PQ-1002 unless and until the Parties have
agreed on the appropriate Milestones, Milestone Payments and
Royalties for such Agreement Compound, as contemplated in
Sections 5.3(d) and 6.4(i) below). Guilford may sublicense,
and grant the right to further sublicense, its rights licensed from
ProQuest under this Agreement. Guilford shall provide a copy of any
such sublicense agreement to ProQuest within thirty (30) days
of its effective date. Each such sublicense shall be consistent
with the terms of this Agreement, except as may otherwise by agreed
in writing by the Parties.
2.3 Transfer of ProQuest Know-how. ProQuest represents and
warrants that no later than ten (10) days following the
Effective Date, it will transfer, disclose or otherwise make
available to Guilford, or will have transferred, disclosed or made
available, all existing ProQuest Know-how for use by Guilford to
perform the “Infusion Experiment” contemplated in
Section 3.2 below and described in Schedule 3 hereto, and
to otherwise Develop and Commercialize PQ-1002. ProQuest further
agrees and covenants to promptly transfer, disclose or make
available, or have transferred, disclosed or made available, all
ProQuest Know-how within its Control, or which it can disclose
without breaching a contractual obligation to a Third Party,
related to any Agreement Compound during the term of this Agreement
to enable Guilford to research, Develop and Commercialize any
Agreement Compound.
ARTICLE 3. SCOPE; ALLOCATION OF RESPONSIBILITIES
OF THE PARTIES
3.1 Cooperation Undertaking; Exclusivity. During the term of
this Agreement, ProQuest agrees to cooperate with Guilford as
Guilford may reasonably request, at Guilford’s expense for
ProQuest’s out-of-pocket expenses, in order to enable or
facilitate the research, Development and Commercialization by
Guilford of PQ-1002 or any other Agreement Compound in accordance
with the terms of this Agreement. Without limiting the generality
of the foregoing, during the term of this Agreement, ProQuest
agrees to promptly disclose to Guilford all ProQuest Patent Rights,
and ProQuest Know-how Controlled by it or which ProQuest can
disclose to Guilford without breaching a contractual obligation to
a Third Party. ProQuest further agrees not to engage in research,
Development or Commercialization of Agreement Compound except under
this Agreement.
3.2 Infusion Study. Following mutual execution and delivery
of this Agreement, Guilford will conduct or cause to be conducted a
preclinical animal chronic infusion study with PQ-1002 in the
manner set forth in Schedule 3 attached hereto (the
“Infusion Study”). Guilford agrees to use Commercially
Reasonable Efforts to commence the Infusion Study as soon as
practicable following the Effective Date, but the Parties
acknowledge and understand that commencement of the Infusion Study
will depend on the availability of Guilford’s contract
research
organization. Guilford agrees to
use Commercially Reasonable Efforts to complete the Infusion Study
and share any results thereof with ProQuest on or before the
Determination Date.
3.3 Guilford Development and Commercialization Undertaking.
During the term of this Agreement, Guilford agrees, using
Commercially Reasonable Efforts, to conduct all Development and
Commercialization of PQ-1002, whether independently or in
collaboration with one or more corporate partners as Guilford may
choose in its sole and absolute discretion. Guilford shall have the
right to control all aspects of such Development and
Commercialization. Specifically, Guilford agrees to use
Commercially Reasonable Efforts to:
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(i)
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commence the first human clinical
trial (whether under an IND or otherwise) of PQ-1002 no later than
18 months following the Determination Date; and
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(ii)
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file the first NDA for PQ-1002 no
later than the fifth anniversary of the Determination
Date.
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If
Guilford in the exercise of Commercially Reasonable Efforts
determines that another Agreement Compound is a more desirable
candidate for Development or Commercialization than PQ-1002, then
Guilford in its sole discretion may elect to Develop and
Commercialize such an Agreement Compound in lieu of PQ-1002, in
which event Guilford shall use Commercially Reasonable Efforts to
so Develop and Commercialize such Agreement Compound (subject to
Section 2.2 above and Sections 5.3(d) and 6.4(i) below).
Guilford, either directly or through any corporate partner(s) it
chooses, shall be responsible for paying all expenses associated
with the Development and Commercialization of PQ-1002 (or any other
Agreement Compound, if applicable).
If
and when PQ-1002 (or another Agreement Compound, if applicable) has
been successfully Developed, Guilford agrees to use its
Commercially Reasonable Efforts to obtain the necessary Regulatory
Approvals and market it in the United States, Europe and Japan, as
well as such other regions and countries as Guilford may deem it
commercially reasonable to do so. In so doing, Guilford shall have
the right to grant one or more exclusive or non-exclusive
marketing, sales, sales agency and/or distribution
rights.
3.4 Regulatory Matters. Without limiting its rights under
this Agreement, Guilford in its sole discretion will have complete
control, authority, and responsibility for the regulatory
strategies adopted for the Development and Commercialization of any
Agreement Compound. Guilford will be responsible for and will own
all Regulatory Filings and Regulatory Approvals for any Agreement
Compound, except as otherwise provided in
Section 10.4(b).
3.5 Manufacturing. Without limiting its rights under this
Agreement, Guilford in its sole discretion will have complete
control, authority and responsibility for manufacturing of an
Agreement Compound, whether directly or through Affiliates,
contracted sublicensees or other Third Parties.
3.6 Hart-Scott Rodino Antitrust Improvements Act of 1976.
Each of ProQuest and Guilford shall cooperate with one another in
determining whether any filing of notification and report forms
under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, is required in connection with the consummation of the
transactions contemplated by this Agreement and the Stock Purchase
Agreement, and preparing and making any such filing and furnishing
information required in connection therewith. If such a filing is
required, each Party shall be responsible for preparing and making
its own filing, and each Party shall be responsible for paying its
own costs and expenses associated with making the filing. Guilford
shall be responsible for the fee required to be paid in connection
with any such filing.
ARTICLE 4. GOVERNANCE
4.1 Governance Committee. The development of PQ-1002 (or
another Agreement Compound, if applicable), and the relationship
between the Parties, will be periodically reviewed by a Governance
Committee which shall be composed of at least five
(5) persons, two (2) of whom shall be representatives of
ProQuest, and the remainder of which will be representatives of
Guilford. Each Party shall, no later than thirty (30) days
following the Effective Date, appoint its representatives to the
Governance Committee by giving written notice to the other Party.
The Governance Committee will be chaired by one representative
designated by Guilford. Members of the Governance Committee shall
serve in such capacities, on such terms and conditions, and for
such duration as shall be determined by the Party appointing same.
Each Party may designate an alternate member to serve temporarily
in the absence of a permanent member designated by such Party. Each
Party may from time to time upon prior written notice change its
representative members on the Governance Committee
4.2 Meetings of the Governance Committee. Unless otherwise
agreed by the Parties from time to time, the Governance Committee
shall hold meetings at such times and places as shall be determined
by the Parties, but in no event shall such meetings be held less
frequently than once every calendar quarter, commencing no more
than sixty (60) days following the Effective Date. Meetings
may be conducted in person or by conference telephone or video
conference. Before the conclusion of a meeting, the date and
location of the next meeting will be decided by the Parties. The
Chairperson may in his/her discretion decide that minutes of the
meeting be kept, by designating any attendee to serve as secretary
of the meeting.
4.3 Purpose of the Governance Committee. The Governance
Committee shall serve as a forum for overseeing the relationship of
the Parties arising out of this Agreement and for jointly reviewing
the Development and Commercialization of PQ-1002 (or any other
Agreement Compound), and shall perform such other functions as the
Parties may agree in order to further the purposes of this
Agreement. At least quarterly at a Governance Committee meeting,
Guilford will deliver a report on the Development and
Commercialization of PQ-1002 (or any other Agreement Compound), and
Guilford will (either at such meeting or as a follow up to such
meeting) provide such further information (including Guilford
Know-how) relating to the Development and Commercialization of
PQ-1002 (or any other Agreement Compound) as ProQuest may
reasonably request, all subject to Article 7 below.
4.4 Agendas. Each Party will use Commercially Reasonable
Efforts to notify the other at least three (3) business days
prior to the date of a meeting of the Governance Committee,
proposing the agenda items it wishes to discuss at such meeting.
Notwithstanding the foregoing, the Governance Committee shall be
free to consider any matter related to this Agreement.
4.5 Independent Contractors. Subject to the terms of this
Agreement, the activities and resources of each Party shall be
managed by such Party, acting independently and in its individual
capacity and the Parties shall have a relationship of independent
contractors with respect to each other. No term or condition of
this Agreement is intended to create nor shall any such term or
condition create any fiduciary duty on the part of either Party for
the benefit of the other, and shall not require either Party to
expend either funds or efforts or commit resources other than as
explicitly agreed in this Agreement.
ARTICLE 5. FEES AND MILESTONES
5.1 Payment at Signing. As payment for the entering into of
this Agreement and the Stock Purchase Agreement, Guilford shall pay
simultaneously with the execution and delivery of this contract
(i) by wire transfer of immediately available funds to the
account of ProQuest the sum of Five Hundred Thousand Dollars
($500,000) and (ii) by check or wire transfer to the Escrow
Agent, the sum of Five Hundred Thousand Dollars ($500,000) which
shall be held by the Escrow Agent in accordance with the terms of
the Escrow Agreement.
5.2 Determination Date. On or before the Determination Date,
Guilford shall determine whether it desires to proceed with the
Development and Commercialization of an Agreement Compound pursuant
to this Agreement and shall provide written instructions to the
Escrow Agent advising it of its decision. The Escrow Agent shall,
upon such instruction and in accordance with the terms of the
Escrow Agreement, release the escrowed funds (i) to ProQuest
at a closing to occur no later than ten (10) days after the
Determination Date (the “First Closing”) in the event
that Guilford desires to proceed or (ii) to Guilford in the
event that Guilford does not desire to proceed, provided that in
either event, ProQuest shall be entitled to any interest (or other
income or gains) earned on the escrowed funds. In the event that
Guilford desires to proceed, the $500,000 payment to ProQuest
(referred to in Section 5.1(i) above) shall be applied towards
the purchase of Common Stock at the First Closing, as set forth in
the Stock Purchase Agreement. In the event that Guilford does not
desire to proceed, then ProQuest shall retain such $500,000 payment
and shall have no obligation to issue Common Stock or convey other
property to Guilford with respect to such payment.
5.3 Milestone Payments.
(a) Development Milestones for PQ-1002. As additional
consideration, Guilford shall pay the following amounts at each
Additional Closing (as defined in the Stock Purchase Agreement) to
occur after completion of the following development milestones
(each a “Milestone”) with respect to PQ-1002 (whether
Developed by Guilford or its Affiliate or sublicensee):
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(i)
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$250,000 upon the Additional Closing
following dosing of the first human; and
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(ii)
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$750,000 upon the Additional Closing
following dosing of the first patient in a Phase II clinical trial;
and
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(iii)
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$1 million upon the Additional
Closing following dosing of the first patient in a Phase III
clinical trial.
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Except as set
forth in the Stock Purchase Agreement, all milestone payments set
forth above shall be deemed payment for the purchase of ProQuest
common stock and, in accordance with the Stock Purchase Agreement,
Additional Closings shall be held following achievement of each
Milestone. The price per share shares of Common Stock to be issued
upon achievement of each Milestone shall be a price per share equal
to 110% of the price per share of Common Stock (or conversion price
per share of securities convertible into the Company’s Common
Stock) issued in the Company’s most recent “Qualified
Equity Infusion” (as that term is defined in the Stock
Purchase Agreement) prior to the relevant Additional
Closing.
(b) NDA or Equivalent Filing Milestone. Guilford shall
pay to ProQuest $2 million following submission of an NDA (or
equivalent application for Regulatory Approval) which would enable
the general marketing of PQ-1002 in a particular country. Of this
$2 million, $1 million shall be paid as cash within five
(5) business days following achievement of this Milestone,
and, except as otherwise set forth in the Stock Purchase Agreement,
$1 million shall be deemed payment for the purchase of
ProQuest common stock upon the achievement of this Milestone,
payable at an Additional Closing in accordance with the Stock
Purchase Agreement.
(c) NDA or Equivalent Approval Milestone. Guilford
shall pay the following amounts in cash (which shall not be deemed
payment towards a purchase of ProQuest common stock) to ProQuest
within five (5) business days following achievement of the
following Milestones for an Agreement Compound (whether by Guilford
or its Affiliates or sublicensees) in the following
territories:
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(i)
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$5 million upon receipt of NDA
clearance and any other Regulatory Approvals needed to enable the
marketing and selling of PQ-1002 generally in the United
States;
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(ii)
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$3 million upon receipt of all
final Regulatory Approvals needed from the first European Country
to enable the marketing and selling of PQ-1002 generally in that
European Country; and
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(iii)
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$1 million upon receipt of all
final Regulatory Approvals needed to enable the marketing and
selling of PQ-1002 generally in Japan.
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(d) Milestone Payments for Other Agreement Compounds.
If Guilford desires to Develop any other Agreement Compound in lieu
of or in addition to PQ-1002, the Parties must first agree in
writing on any Milestone Payments for the Development of such
Agreement Compound.
(e) Notification of Milestones. No later than five
(5) business days following the achievement of each Milestone,
Guilford shall notify ProQuest in writing that such Milestone has
occurred.
ARTICLE 6. ROYALTIES
6.1 Royalties. Guilford agrees to pay ProQuest a running
royalty on worldwide Net Sales of PQ-1002 (“Royalty”)
in the following amounts:
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(i)
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five percent (5%) of Net Sales on
the first One Hundred Million Dollars ($100,000,000) in worldwide
Net Sales in any calendar year;
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(ii)
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seven percent (7%) on the next One
Hundred Million Dollars ( i.e. , between $100,000,000 and
$200,000,000) in worldwide Net Sales in any calendar year;
and
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(iii)
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nine percent (9%) on all amounts of
worldwide Net Sales in excess of Two Hundred Million Dollars
($200,000,000) in any such calendar year.
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6.2 Third Party Royalty Credit . On a country by country
basis, fifty percent (50%) of any Third Party Royalties paid by
Guilford will be creditable against Royalties payable to ProQuest
under this Agreement. Credit for Third Party Royalties will be made
on a quarterly basis; provided, however, that no such credit shall
reduce the amount of Royalties paid by Guilford for a particular
calendar quarter by more than 50%.
6.3 Term of Royalty. Royalty will be payable on a country by
country basis until the last to expire of the patent or patents in
such country covering PQ-1002, and, in a country where no patent
ever issued covering PQ-1002, then until the last to expire of the
patent or patents in the U.S., France, Germany or the United
Kingdom covering PQ-1002.
6.4 Reports and Payments.
(a) Cumulative Royalties. The obligation to pay
Royalties under this Article 6 shall be imposed only once
(i) with respect to any sale of the same unit of Program
Product; and (ii) with respect to a single unit of Program
Product regardless of how many valid issued or, assuming they were
to issue, patent claims included in Program Patent Rights would be
infringed by Third Parties by the making, using or selling of such
Program Product.
(b) Statements and Payments. Guilford shall deliver to
ProQuest within sixty (60) days after the end of
each calendar quarter, a
statement certified by Guilford as accurate to the best of its
ability based on information available to Guilford, setting forth
for the previous quarter the following information on a
country-by-country basis: (i) Net Sales of Program Products;
(ii) the basis for any Royalty adjustments; and (iii) the
Royalty due hereunder, which report shall be accompanied by a
remittance of the Royalty due.
(c) Interest. If Guilford fails to pay undisputed
Royalty within fifteen (15) days of the date such Royalty is
due, Guilford shall pay interest on the amount of such overdue
Royalty (from the original due date) at the rate of 10% per annum
until it is paid in full. If any disputed Royalty withheld by
Guilford is later determined to have been properly owing as of the
original due date, Guilford shall likewise pay interest on the
amount of such Royalty withheld at such interest rate from the
original due date until date of payment.
(d) Taxes. All taxes levied on account of Royalties
accruing under this Agreement shall be paid by ProQuest. If laws or
regulations require withholding of taxes from any payment by
Guilford to ProQuest hereunder, the taxes will be deducted by
Guilford from remittable Royalty to ProQuest and will be paid by
Guilford to the proper taxing authority. Guilford will furnish
ProQuest with the original copies of all official receipts for such
taxes. In the event of any such withholding, the Parties agree to
confer and cooperate in good faith regarding any filings with tax
authorities and other measures that may be taken to minimize the
amount of any such withholding.
(e) Currency. All amounts payable and calculations
hereunder shall be in United States dollars, and all payments under
this Article 6 shall be made to ProQuest. As applicable, Net
Sales shall be translated into United States dollars at the rate of
exchange at which United States dollars are listed in International
Financial Statistics (publisher, International Monetary Fund) or if
it is not available, The Wall Street Journal for the currency of
the country in which the sale is made at the average of the
calendar quarter in which such sales were made.
(f) Audit. Guilford shall maintain (and shall cause its
Affiliates and sublicensees to maintain) books and records as
necessary to allow the accurate calculation of Royalties due
hereunder including any records required to calculate any Royalty
adjustments hereunder. Once per yea
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