Exhibit 10.10
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Confidential Materials omitted and filed separately with the
Securities and Commission. Asterisks denote omissions.
LICENSE AGREEMENT
This License Agreement (the "Agreement") is made as of this 18th day
of December, 2003 between Xxxxxx Laboratories, a corporation organized under the
laws of the State of Illinois, USA, with its principal office at 000 Xxxxxx Xxxx
Xxxx, Xxxxxx Xxxx, Xxxxxxxx 00000 ("Abbott") and Critical Therapeutics, Inc., a
corporation organized under the laws of the State of Delaware, USA, with its
principal office at 000 Xxxxxxxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxxxx,
Xxxxxxxxxxxxx 00000 ("CTI").
INTRODUCTION
1. Abbott holds the Patents and Know How related to the Product
in the Field (all as hereinafter defined);
2. CTI wishes to obtain, and Abbott wishes to grant to CTI, an
exclusive license under the Patents and Know How related to the Product in the
Field in order to permit CTI to pursue the marketing, distribution, sale and
commercialization of the Product (as hereinafter defined) in the Field; and
3. CTI wishes to obtain, and Abbott wishes to grant to CTI,
certain rights under Xxxxxx'x agreement with Jagotec AG.
NOW THEREFORE, in consideration of the mutual obligations and promises
as set forth herein, the parties do hereby agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms shall have
the following respective meanings:
1.1 "Acusphere" shall mean Acusphere, Inc.
1.2 "Affiliate" shall mean any corporation, company, partnership,
joint venture and/or other entity which controls, is controlled by, or is under
common control of either Party hereto, except for TAP Pharmaceutical Products,
Inc. and its subsidiaries. For purposes of this definition, control shall mean
direct or indirect ownership of at least fifty percent (50%) of the stock or
participating shares entitled to vote for the election of directors (but only as
long as such ownership exists).
1.3 "Commercially Reasonable Efforts" shall mean with respect to
the efforts to be expended by a Party with respect to any objective, reasonable,
diligent, good faith efforts to accomplish such objective as such Party would
normally use to accomplish a similar objective under similar circumstances, it
being understood and agreed that with respect to the development or
commercialization of a Product, such efforts shall be substantially equivalent
to those efforts and resources commonly used by a mid-size biotechnology company
for a similar pharmaceutical product owned by it or to which it has rights,
which product is at a similar stage in its development or product life and is of
similar market potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative products in the marketplace, the
patent and other proprietary position of the product, the likelihood of
regulatory approval given the regulatory structure involved, the profitability
of the product including the royalties payable
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to licensors of patent or other intellectual property rights, alternative
products and other relevant factors. Commercially Reasonable Efforts shall be
determined on a market-by-market and Indication-by-Indication basis for a
particular Product, and it is anticipated that the level of effort will be
different for different markets, and will change over time, reflecting changes
in the status of the Product and the market(s) involved.
1.4 "Compound" shall mean Zileuton.
1.5 "Confidential Information" shall mean any information data or
business plans relating to the Compound, Product, Patents and/or the know-how
which a Party discloses to the other Party, including, without limitation, the
parties to and terms of this Agreement, information protected by that certain
Option Agreement dated May 22, 2003 between Abbott and CTI, that certain
Bilateral Confidentiality Disclosure Agreement dated March 5, 2003 between
Abbott and CTI and that certain Bilateral Confidentiality Disclosure Agreement
dated August 27, 2002 between Abbott and CTI's agent, Pleiades Consultation
Inc., an Arizona corporation, except any portion thereof which:
(i) is known to the receiving Party at the time of
disclosure and documented by written records;
(ii) is disclosed to the receiving Party by a Third Party
that has a right to make such disclosure;
(iii) becomes patented, published or otherwise part of the
public domain as a result of acts by a Third Party;
or
(iv) is independently developed by or for the receiving
Party as evidenced by its written records.
1.6 "Effective Date" shall mean the date of this Agreement set
forth in the opening paragraph hereof.
1.7 "Excluded Pediatrics" shall mean research, diagnostics,
therapeutics, and services relating to humans aged seven (7) years and under for
intravenous and buccal administration of the Compound.
1.8 "Excluded Product" shall mean the finished form of the
Compound currently marketed under the trade name of Zyflo.
1.9 "FDA" shall mean the United States Food and Drug
Administration.
1.10 "Field" shall mean research, diagnostics, therapeutics, and
services for all human medical conditions or diseases, except for research,
diagnostics, therapeutics, and services related to the following: (i) Excluded
Pediatrics, (ii) cardiovascular and vascular devices, including, without
limitation, stents, and (iii) Excluded Product.
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1.11 "First Commercial Sale" shall mean the first sale of Product
in a country within the Territory by CTI, its Affiliate or sublicensee to any
Third Party after receipt of Regulatory Approval for the applicable country.
1.12 "IND" shall mean any Investigational New Drug Application
filed with the FDA for marketing approval for a drug pursuant to the Federal
Drug and Cosmetic Act (21 U.S.C. Section 321, et seq.) and the regulations
promulgated thereunder, including any amendments or supplements thereto.
1.13 "Indication" shall mean a distinct disease or condition in the
Field for which Regulatory Approval has been sought and/or obtained, including,
without limitation, all forms of the following diseases or conditions: asthma,
chronic obstructive pulmonary disease, and emphysema.
1.14 "Know How" shall mean any proprietary technology (other than
the Patents) owned by or licensed (with a right of sublicense) to Abbott as of
the Effective Date or at any time during the Term relating to the use of the
Product in the Field.
1.15 "License Agreement" shall mean that certain License Agreement
dated October 3, 1996 between Abbott and Jagotec AG, a Swiss corporation (nka
Skye Pharma) regarding certain patents, know how and manufacturing rights
regarding the controlled release formulation of the Compound.
1.16 "License Fee" shall mean a fee of Xxx Xxxxxxx Xxxx Xxxxxxx
Xxxxxxxx Xxxxxx Xxxxxx Dollars ($1,500,000).
1.17 "NDA" shall mean a New Drug Application, and all supplements
and amendments thereto filed with the FDA, for a Product.
1.18 "Net Sales" means, with respect to a Product, the gross amount
invoiced by CTI, its Affiliates and/or its sublicensees on sales or other
dispositions of Product to Third Parties or otherwise directly or indirectly
paid to or earned by CTI with respect to the sale of Product, less the following
deductions:
(a) trade, cash and/or quantity discounts not already
reflected in the amount invoiced, to the extent included in the gross amount
invoiced;
(b) allowances and adjustments credited or payable,
including credit for spoiled, damaged, outdated, recalled and returned Product,
to the extent related to the gross amount invoiced and substantiated by
reasonable documentation;
(c) freight, distribution, insurance and other
transportation charges incurred in shipping a Product to Third Parties, to the
extent identified as such in the invoice to the Third Party, to the extent
included in the gross amount invoiced;
(d) amounts repaid or credited by reason of rejections,
defects, recalls or returns or because of chargebacks, refunds, rebates,
retroactive price reductions or billing errors; and
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(e) all tariffs, duties, excises, sales taxes or other
taxes (including VAT) and custom duties imposed upon Products, in each case to
the extent invoiced to customers or otherwise included within gross amounts
invoiced; and
(f) price reductions imposed by government authorities.
Such amounts shall be determined from the books and records of CTI, its
Affiliates and/or its sublicensees, maintained in accordance with United States
generally accepted accounting principles, consistently applied. In the case of
any sale of Products for consideration other than cash, such as barter or
countertrade, Net Sales shall be calculated on the fair market value of the
consideration received. In the event the Product is sold as part of a
Combination Product (as defined below), the Net Sales from the Combination
Product, for the purposes of determining royalty payments, shall be determined
by multiplying the Net Sales of the Combination Product during the applicable
royalty reporting period, by the fraction, A/A+B, where A is the average sale
price of the Product when sold separately in finished form and B is the average
sale price of the other product(s) included in the Combination Product when sold
separately in finished form, in each case during the applicable royalty
reporting period or, if sales of both the Product and the other product(s) did
not occur in such period, then in the most recent royalty reporting period in
which sales of both occurred. In the event that such average sale price cannot
be determined for both the Product and all other products(s) included in the
Combination Product, Net Sales for the purposes of determining royalty payments
shall be calculated by multiplying the Net Sales of the Combination Product by
the fraction of C/(C+D) where C is the fair market value of the Product and D is
the fair market value of all other pharmaceutical product(s) included in the
Combination Product. In such event, CTI shall in good faith make a determination
of the respective fair market values of the Product and all other pharmaceutical
products included in the Combination Product, and shall notify Abbott of such
determination and provide Abbott with sufficient data to support such
determination. Abbott shall have the right to review such determination and
supporting data, and to notify CTI if it disagrees with such determination. If
Abbott does not agree with such determination and if the Parties are unable to
agree in good faith as to such respective fair market values, then such matter
shall be referred to dispute resolution pursuant to Section 13.8. As used above,
the term "Combination Product" means any pharmaceutical product that consists of
a Product and other active compounds and/or active ingredients.
1.19 "Party" shall mean Abbott or CTI, as appropriate in the
context, and "Parties" shall mean Abbott and CTI, collectively.
1.20 "Patents" shall mean (i) those patents and patent applications
identified on Schedule 1, that are owned or licensed (with a right to
sublicense) to Abbott as of the Effective Date and relate to the Product in the
Field; (ii) any and all patents, including foreign equivalents, which may issue
from said applications; and (iii) any and all substitutions, extensions,
additions, reissues, re-examinations, renewals, divisions, continuations,
continuations-in-part or supplementary protection certificates derived from (i).
1.21 "Product" shall mean any pharmaceutical product which
incorporates the Compound, including without limitation Zileuton CR and Zileuton
IV, but excluding the Excluded Product, for use in the Field, and (a) use of
which by CTI, an Affiliate or sublicensee
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of CTI would be an infringement of a Valid Claim (as hereinafter defined) of the
Patents but for the grant of the license from Abbott to CTI, or (b) embodies
Know-How.
1.22 "Regulatory Approval" shall mean the approval to sell Product
granted by any Regulatory Authority (as defined below) with authority or
jurisdiction over the testing, manufacture, use, storage, import, transport,
promotion, marketing and sale of a diagnostic, research, therapeutic or service
product in a country.
1.23 "Regulatory Authority" shall mean any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity, including, but not limited to, the FDA.
1.24 "Research Agreement" shall mean that certain Research
Agreement dated May 14, 2003 between Acusphere and Abbott regarding use of
Acusphere's drug delivery system with certain of Xxxxxx'x Know How regarding the
Compound.
1.25 "Skye Pharma" shall mean the name to which Jagotec AG, a Swiss
corporation, is currently referred.
1.26 "Term" shall have the meaning set forth in Section 12.1
hereof.
1.27 "Territory" shall mean the entire world.
1.28 "Third Party" shall mean any entity other than Abbott and its
Affiliates or CTI and its Affiliates.
1.29 "Valid Claim" shall mean a claim of an issued and unexpired
patent whose enforceability has not been effected by any of the following: (i)
irretrievable lapse, revocation, or abandonment, (ii) unenforceable or invalid
by a decision of a court or other governmental agency of competent jurisdiction,
unappealable or un-appealed within the time allowed for appeal, and/or (iii)
disclaimer or admission of invalidity or unenforceability through reissue,
re-examination, opposition, nullity action or invalidation suit response,
disclaimer or otherwise.
1.30 "Zileuton CR" shall mean the controlled release formulation of
the Compound, which is being investigated by CTI.
1.31 "Zileuton IV" shall mean the intravenous formulation of the
Compound, which is being investigated by CTI.
1.32 "Zyflo" shall mean the immediate release formulation of the
Compound for which Abbott has obtained FDA approval and is exemplified by the
product that is currently marketed within the United States by the trade name
Zyflo.
2. LICENSE GRANTS.
2.1 Exclusive License. Subject to Section 12.4,
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(i) Abbott hereby grants to CTI and its Affiliates an
exclusive license under the Patents and Know How to
develop, have developed, make, have made, use, have
used, import, have imported, offer to sell, sell, and
have sold the Product in the Territory.
(ii) Abbott hereby grants to CTI and its Affiliates,
subject to Skye Pharma's written consent, an
exclusive sublicense under Xxxxxx'x rights to Patents
and Know How pursuant to the License Agreement to
develop, have developed, make, have made, use, have
used, import, have imported, offer to sell, sell, and
have sold Zileuton CR in the Field in the Territory.
CTI acknowledges and agrees that CTI is responsible
to Skye Pharma for any and all payments due Skye
Pharma or its affiliates under the License Agreement
both by Abbott and CTI. CTI shall indemnify, defend
and hold harmless Abbott from any and all liability
relating to either CTI's or Xxxxxx'x obligations to
Skye Pharma under the License Agreement or in regard
to Zileuton CR, except to the extent such liability
arises out of Xxxxxx'x gross negligence or willful
misconduct.
2.2 Right to Sublicense. CTI shall have the right to grant
sub-licenses to the rights granted under Section 2.1, subject to Section 2.4
below and any consent requirements that Skye Pharma retains regarding the rights
granted in Section 2.1 (ii). In the event that CTI grants a sublicense, CTI
shall notify Abbott of each such sublicense without unreasonable delay following
any such grant of sublicense. CTI shall remain fully responsible for the
compliance by such sub-licensees with the terms and conditions of this Agreement
as if such sub-licensees were CTI hereunder.
2.3 Right to Appoint Distributors. Notwithstanding the
restrictions under section 2.4 below, CTI shall have the right, at all times, to
appoint distributors in the Territory for the sale of the Product. CTI shall
ensure that its distributors act fully in compliance with the terms and
conditions of this Agreement.
2.4 Co-Commercialization Right of First Negotiation. In the event
that CTI decides to sublicense its rights under Section 2.1 in all or part of
the Territory, CTI shall first provide written notice to Abbott of such
decision, including the terms which CTI intends to propose to potential Third
Party sublicensee (a "co-commercialization opportunity"). Abbott shall have the
right to enter into good faith negotiations relating to such
co-commercialization opportunity for the Product by providing written notice to
CTI within forty five (45) days after receipt of CTI' s notice. If Abbott
provides such notice to CTI within such forty five (45) day period then the
Parties shall negotiate in good faith relating to such co-commercialization
opportunity for a period of seventy five (75) days, or such shorter or longer
period as is mutually agreed to by the Parties. If Abbott does not provide
notice to CTI within such initial forty five (45) day period or indicates it is
not interested in such co-commercialization opportunity, then CTI shall be free
to enter into an arrangement with a Third Party on such terms as CTI and such
Third Party may agree upon. If Abbott exercises its right of first negotiation
and the Parties are unable to reach mutual agreement as to Xxxxxx'x
participation in such co-commercialization opportunity within such seventy five
(75) day period, then CTI shall be free to enter into an arrangement with a
Third Party on terms (financial and non-financial) that are not materially more
favorable to such
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Third Party, taken as a whole, than the terms (financial and non-financial) last
discussed with Abbott. Notwithstanding the foregoing, in the event that the
Parties have not been able to agree to the terms of such co-commercialization
opportunity by the last day of such seventy five (75) day period, the Parties
shall consider, in good faith, extending such seventy five (75) day period for
up to thirty (30) days, provided, that the Parties have been diligently pursuing
a final agreement on the terms of the co-commercialization opportunity.
2.5 Covenant Not to Xxx. In the event the making, having made,
use, offer for sale, sale or import by CTI, its Affiliates, sublicensees or
distributors of Product, as formulated as of the Effective Date, would infringe
during the term of this Agreement a claim of issued letters patent which is
owned by or licensed to Abbott and which patent is not covered by the grant in
Section 2.1, Abbott hereby covenants not to xxx CTI under such issued letters
patent solely for CTI to develop, make, have made, use, sell, offer for sale or
import Product in the Territory and in the Field.
2.6 Section 365(n) of the Bankruptcy Code. All rights and licenses
granted under or pursuant to any section of this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code
licenses of rights to "intellectual property" as defined under Section 101(35A)
of the Bankruptcy Code. The Parties shall retain and may fully exercise all of
their respective rights and elections under the Bankruptcy Code.
3. TECHNOLOGY TRANSFER.
3.1 Completion of Technology Transfer. Subject to Section 6,
Abbott will use Commercially Reasonable Efforts to transfer knowledge of its
present technology as identified on Schedule 2 for the manufacture and
validation of Product, including Xxxxxx'x active pharmaceutical ingredient
process ("API Process") and the controlled release formulation ("CR
Formulation") data, to CTI (or a CTI designee) to allow CTI to further develop
and manufacture Product. CTI will reimburse Abbott for its actual costs and
expenses in this technology transfer.
3.2 Third Party Manufacturers. Abbott shall use Commercially
Reasonable Efforts, by telephone, correspondence or other appropriate means as
agreed by the Parties, to assist CTI in obtaining the right to work with
Acusphere and the exclusive right to use Acusphere's patents and know how
related to the delivery system for Zileuton IV in the Field in the Territory. In
the event that CTI obtains such rights, CTI acknowledges and agrees that CTI
will be responsible to Acusphere for any and all payments due Acusphere or its
affiliates under the Research Agreement both by Abbott and CTI. CTI shall
indemnify, defend and hold harmless Abbott from any and all liability relating
to either CTI's or Xxxxxx'x obligations to Acusphere under the Research
Agreement or in regard to Zileuton IV, except to the extent such liability
arises out of Xxxxxx'x gross negligence or willful misconduct.
3.3 Supply of Bulk Drug. CTI agrees to supply Abbott at no cost to
Abbott with up to 500 kilograms, per calendar year during the Term, of bulk
active pharmaceutical ingredient substance required for Xxxxxx'x research and
development activities related to Excluded Pediatrics. If Abbott requires more
than 500 kilograms of bulk active pharmaceutical ingredient substance for
Xxxxxx'x research and development activities related to Excluded Pediatrics in
any given year during the Term, CTI shall supply Abbott with Xxxxxx'x
requirements for bulk drug
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substance at CTI's cost (which cost shall only include CTI's cost of direct
materials; direct labor; manufacturing overhead; and a reasonable allocation of
general and administrative expenses and facilities expenses), such amount to be
verified in writing to Xxxxxx'x reasonable satisfaction. CTI shall supply Abbott
with Xxxxxx'x commercial requirements for bulk drug substance at CTI's cost (as
defined in this Section 3.3), such amount to be verified in writing to Xxxxxx'x
reasonable satisfaction.
4. ACCESS TO IND AND NDA; FDA; SAFETY.
4.1 During the Term, Abbott shall permit CTI (at CTI's expense) to
have access to Xxxxxx'x clinical filings with the FDA and any applicable foreign
regulatory authorities for Zileuton CR, as available, and copies of all
associated documents (subject to reimbursement for actual costs to Abbott
including, but not limited to accessing, copying, and shipping documents, and
any personnel or operational costs incurred by Abbott in support of CTI during
the Term) for the purposes of CTI obtaining regulatory approval of Product.
Abbott shall provide CTI with a letter of cross reference to Xxxxxx'x applicable
IND and NDA files.
4.2 CTI shall comply with all present and future laws, including,
without limitation, the Federal Food, Drug and Cosmetic Act, rules, orders,
ordinances, regulations, statutes, requirements, codes, executive orders, rules
of common law, and any judicial interpretations thereof, extraordinary as well
as ordinary, of all governmental authorities, including, without limitation, the
FDA. Furthermore, each Party acknowledges and understands that it has no
authority to represent the other Party in any way before the FDA and as such
each Party will not make any representations or commitments in the other Party's
name with the FDA.
4.3 Each Party warrants that it shall advise the other of any
serious adverse events relating in any way to the Compound or the Product as and
when such serious adverse events are reported or reportable by it to the
Regulatory Authorities. In addition, within ninety (90) days after the date of
this Agreement, the Parties shall use good faith efforts to enter into an
agreement to initiate a process for the exchange of adverse event safety data in
a mutually agreed format, including but not limited to, postmarketing
spontaneous reports received by a Party or its Affiliates in order to monitor
the safety of the Compound or the Product and to meet reporting requirements
with any applicable Regulatory Authority.
5. PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
5.1 Development. CTI shall be solely responsible for development
and registration of Product, and shall use Commercially Reasonable Efforts to
obtain Regulatory Approval for Product in at least one Indication in the United
States.
5.2 Commercialization. Upon obtaining Regulatory Approval for
Product in any country in the Territory, CTI shall use Commercially Reasonable
Efforts to market and sell such Product in such country.
5.3 Excuse for Non-Performance. The obligations of CTI with
respect to any Product Indication or formulation under this Article 5 are
expressly conditioned upon the continuing absence of any adverse condition or
event relating to the safety or efficacy of such Product
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Indication or formulation, and the obligation of CTI to develop or market such
Product Indication or formulation shall be delayed or suspended so long as such
condition or event exists.
6. FINANCIAL PROVISIONS.
6.1 License Fee. In consideration of the exclusive licenses
granted hereunder, CTI shall pay to Abbott a lump sum payment of the License Fee
on the Effective Date.
6.2 Milestones. CTI shall make the following payments to Abbott
within thirty (30) days after the achievement of the indicated milestones:
(i) [**] $[**]
(ii) [**] $[**]
(iii) [**] $[**]
(iv) [**] $[**]
(v) [**] $[**]
(vi) [**] $[**]
(vii) [**] $[**]
(viii) [**]. $[**]
6.3 Royalties. CTI shall pay to Abbott royalties on Net Sales of
Product at the rates set forth below:
(i) [**]% of total annual Net Sales of Product of $[**] - $[**]
(ii) [**]% of total annual Net Sales of Product of $[**] - $[**]
(iii) [**]% of total annual Net Sales of Product of $[**] - $[**]
(iv) [**]% of total annual Net Sales of Product of $[**] - $[**]
(v) [**]% of total annual Net Sales of Product of > $[**]
Royalties shall be based on the total annual Net Sales of Product in all
countries during a particular calendar year for which a royalty is due. By way
of example, if Net Sales in a calendar year equaled $[**], royalties would be
calculated as follows: (i) [**]% of the first $[**]($[**]), (ii) [**]% of the
next $[**] ($[**]), (iii) [**]% of the next $[**] ($[**]), and (iv) [**]% of the
final $[**] ($[**]), for a total of $[**].
6.4 Term of Royalty Payments. Royalties shall be paid on a
country-by-country basis for a period often (10) years from First Commercial
Sale of Product in each such country.
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6.5 Payments to Third Parties. Any obligations due to Skye Pharma
(Jago) and any other Third Parties for the CR Formulation will be the
responsibility of CTI.
6.6 Royalties Payable Only Once. The obligation to pay royalties
is imposed only once with respect to the same unit of a Product.
6.7 Sales to Affiliates and Sublicensees. Sales of Products
between CTI and its Affiliates or permitted sublicensees, or among such
Affiliates and permitted sublicensees, shall not be subject to royalties under
this Article 6, but in such cases the royalties shall be calculated on the Net
Sales by such Affiliates or sublicensees to a Third Party.
6.8 Royalty Reports; Royalty Payments. CTI shall deliver to
Abbott, within sixty (60) days after the end of each calendar quarter,
sufficiently detailed written accountings of Net Sales of Products that are
subject to royalty payments due to Abbott or Third Parties, in accordance with
this Agreement, including, without limitation, Acusphere and Skye Pharma, for
such calendar quarter. Such quarterly reports shall indicate gross sales on a
country-by-country basis, the deductions from gross sales used in calculating
Net Sales and the resulting calculation of royalties. When CTI delivers such
accountings to Abbott, CTI shall also deliver all royalty payments due under
Section 6.3 to Abbott for the calendar quarter. With respect to sales of
products invoiced in United States Dollars, the sales and royalties payable
shall be expressed in United States Dollars. With respect to sales of products
invoiced in a currency other than United States Dollars, such foreign currency
amounts shall be converted into United States Dollars at the official average
monthly rates used by Xxxxxx Laboratories for conversion of its monthly
financial statements - the average B.2.0 rate. The month end B.2.0 rate is
determined by taking the numbers from the 9:00 am CST Reuters screen at the
second to last business day of each month (with the exception of November, when
the rate is taken on the last business day). With the exception of the Euro,
British Pound, Australian Dollar and New Zealand Dollar, the ask price is used.
For the four (4) aforementioned currencies the bid rate is used. An average
monthly rate is determined by taking the calculated average of the prior last
business day of the month book rate and the current last business day of the
month book rate.
6.9 Audits by Abbott. CTI shall keep, and shall require its
Affiliates and sublicensees to keep, complete and accurate records of the latest
three (3) years of sales of Products to which the obligation to pay royalties to
Abbott attach hereunder. For the sole purpose of verifying royalties payable to
Abbott, Abbott shall have the right annually at Xxxxxx'x expense to retain an
independent certified public accountant selected by Abbott and reasonably
acceptable to CTI, to review such records in the location(s) where such records
are maintained by CTI, its Affiliates or its sublicensees upon reasonable notice
and during regular business hours and under obligations of confidence. Results
of such review shall be made available to both CTI and Xxxxxx. If the review
reflects an underpayment of royalties to Xxxxxx, such underpayment shall be
promptly remitted to Xxxxxx. If the underpayment is equal to or greater than
five percent (5%) of the royalty amount that was otherwise due, CTI shall pay
all of the reasonable, out-of-pocket costs of such review. If the review
reflects an overpayment of royalties to Xxxxxx, the amount of such overpayment
shall be credited against future royalties owed by CTI to Xxxxxx.
6.10 Tax Withholding. The Parties shall use their best efforts to
reduce tax withholding on payments made to Xxxxxx hereunder. Notwithstanding
such efforts, if tax
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withholdings under the laws of any country are required with respect to payments
to Xxxxxx, CTI shall withhold the required amount and pay it to the appropriate
governmental authority. In such a case, CTI will promptly provide Xxxxxx with
original receipts or other evidence sufficient to allow Xxxxxx to document such
tax withholdings adequately for purposes of claiming foreign tax credits and
similar benefits.
7. REPRESENTATIONS AND WARRANTIES OF XXXXXX.
7.1 Xxxxxx represents and warrants that it is duly organized,
validly existing and in good standing under the laws of the State of Illinois,
that it has full corporate power and authority to enter into this Agreement and
to carry out its provisions, and that there are no outstanding agreements,
assignments or encumbrances in existence that are inconsistent with the
provisions of this Agreement. Xxxxxx further represents and warrants that it is
duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder.
7.2 To the best of Xxxxxx'x knowledge, there are no patent
infringement actions, litigation or other proceedings, pending or threatened, by
Third Parties which affect or may affect the Patents.
7.3 The Patents are a complete list of all patents and patent
applications that are owned by or licensed (with the right to grant sublicenses)
to Xxxxxx and, to the best of Xxxxxx'x knowledge, that are necessary and are
used for the manufacture, use or sale of the Compound. Xxxxxx has not previously
assigned, transferred, licensed, conveyed or otherwise encumbered its right,
title and interest in the Patents.
7.4 To the best of Xxxxxx'x knowledge, the manufacture, use and
sale of the Compound in the Field in the Territory does not infringe upon any
intellectual property rights of any Third Party, and as of the Effective Date
there are no pending or threatened claims or litigation relating to the Patents
or the manufacture, use or sale of the Compound in the Field in the Territory.
7.5 As of the Effective Date Xxxxxx has disclosed to CTI, and
provided to CTI a copy of, all agreements between Xxxxxx and any Third Parties
which are related to the development, registration, manufacture, use, marketing,
distribution, importation, sale or commercialization of the Compound in the
Field in the Territory.
8. REPRESENTATIONS AND WARRANTIES OF CTI.
8.1 CTI represents and warrants that it is duly organized, validly
existing and in good standing under the laws of the State of Delaware and is
authorized to conduct business in the Commonwealth of Massachusetts, that it has
full corporate power and authority to enter into this Agreement and to carry out
its provisions, and that there are no outstanding agreements, assignments or
encumbrances in existence that are inconsistent with the provisions of this
Agreement. CTI further represents and warrants that it is duly authorized to
execute and deliver this Agreement and to perform its obligations hereunder.
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9. CONFIDENTIALITY AND NON-DISCLOSURE.
9.1 Confidential Information. Neither Party shall use or disclose
any Confidential Information received by it pursuant to this Agreement except
for the purposes set forth in this Agreement without the prior written consent
of the other. CTI shall have the right to disclose Confidential Information to
its agent Pleiades Consultation Inc. in accordance with that certain Bilateral
Confidentiality Disclosure Agreement dated August 27, 2002 between Xxxxxx and
CTI's agent, Pleiades Consultation Inc., an Arizona corporation, as necessary
for the exercise by CTI of its rights and obligations under this Agreement. This
obligation will continue until seven (7) years following the expiration or
termination of this Agreement.
9.2 Exceptions. Nothing contained in this Article shall be
construed to restrict the Parties from disclosing Confidential Information as
required in clauses (i) through (iv) below, provided in each case the party
requesting to make such disclosure shall timely inform the other party and use
all reasonable efforts to limit the disclosure and maintain the confidentiality
of such Confidential Information to the extent possible. In addition, the party
requesting to make such disclosure shall permit the other party to attempt to
limit such disclosure by appropriate legal means:
(i) to comply with applicable laws, to defend or
prosecute litigation, or to comply with governmental
regulations;
(ii) for audit purposes; or
(iii) by Court order or other government order or request;
or
(iv) to its existing and/or potential collaborators,
distributors, sublicenses, investors or lenders,
provided that such parties or individuals receive
such Confidential Information, (x) on a need to know
basis only and (y) after an agreement in writing to
hold such Confidential Information under the same or
greater standards of confidentiality as provided for
in this Agreement.
9.3 Tax Disclosure. Notwithstanding anything herein to the
contrary, each Party (and their employees and agents) may disclose to any and
all persons, without limitation of any kind, the tax treatment and tax structure
of the transactions contemplated by this Agreement and all materials of any kind
(including opinions and other tax analyses) that are provided to each Party
relating to such tax treatment and tax structure. The preceding sentence shall
be effective immediately upon the commencement of discussions between the
Parties (whether such discussions commenced orally, in writing or otherwise)
that are related to the terms of this Agreement.
9.4 SEC Filings. Either Party may disclose the existence and terms
of this Agreement to the extent required to comply with applicable laws,
including without limitation the rules and regulations promulgated by the United
States Securities and Exchange Commission. Notwithstanding the foregoing, prior
to disclosing this Agreement or any of the terms hereof pursuant to this Section
9.4, the Parties will consult with one another on the terms of this Agreement to
be redacted in making any such disclosure. If a Party discloses this Agreement
or
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any of the terms hereof in accordance with this Section 9.4, such Party agrees,
at its own expense, to seek confidential treatment of portions of this Agreement
or such terms, as may be reasonably requested by the other Party.
10. INTELLECTUAL PROPERTY.
10.1 Patents. Xxxxxx shall, during the Term, be responsible for the
filing, prosecution and maintenance of the Patents. In the event that Xxxxxx
elects to not continue the filing, prosecution or maintenance of any of the
Patents, then Xxxxxx shall notify CTI of such election at least sixty (60) days
prior to the last available date for action to preserve such Patents. If CTI
elects to continue the filing, prosecution or maintenance of any such Patent
Right, then CTI may do so at its sole expense; provided, however, that CTI may
deduct all out of pocket expenses and reasonable attorney's fees incurred in
preserving such Patent Right from the royalties due to Xxxxxx.
10.2 Notification of Claim. If a Third Party notifies CTI or
Xxxxxx, or their respective Affiliates or sublicensees, that any act by CTI, or
its Affiliates or sublicensees, utilizing the Patents in the Field allegedly
infringes any patent rights of such Third Party, CTI or Xxxxxx shall promptly
notify the other in writing.
10.3 Third Party Infringement.
(a) Xxxxxx shall have the first right but not the
obligation to take reasonable actions to protect the Patents from infringement
in the Field, when, from its own knowledge or upon notice from CTI, Xxxxxx
becomes aware of the reasonable probability that such infringement or
unauthorized use exists in the Field.
(b) Within ninety (90) days of becoming aware of the
infringement of the Patents in the Field Xxxxxx shall decide whether to
institute an infringement suit or take other appropriate action that it believes
is reasonably required to protect the Patents in the Field. If Xxxxxx fails to
institute such suit or take such action within such ninety (90) day period, then
CTI shall have the right at its sole discretion to institute such suit or other
appropriate action in the name of either or both Parties. In either such event,
each Party shall cooperate with the other Party to the extent reasonably
possible, including the joining of suit if necessary or desirable.
(c) Each Party shall assume and pay all of its own
out-of-pocket costs incurred in connection with any litigation or proceedings
undertaken by such Party described in this Section 10.3, including, without
limitation, the fees and expenses of that Party's counsel.
(d) In the event that either CTI or Xxxxxx takes action
pursuant to subsection (b) above, the other Party shall cooperate with the Party
so acting to the extent reasonably possible, including the joining of suit if
necessary or desirable. Neither Party shall settle or compromise any claim or
proceeding relating to Patents without obtaining the prior written consent of
the other Party, such consent not to be unreasonably withheld.
(e) Any recovery obtained by any Party as a result of any
proceeding described in this Section 10.3, by settlement or otherwise, shall be
applied in the following order of priority:
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(i) first, to reimburse each Party for all
litigation costs in connection with such proceeding paid by that Party and not
otherwise recovered (on a pro rata basis based on each Party's respective
litigation costs, to the extent the recovery was less than all such litigation
costs); and
(ii) second, in the event that the action was
brought by Xxxxxx, then the remainder of the recovery shall be divided equally
between the Parties; or
(iii) third, in the event that the action was
brought by CTI, then the remainder of the recovery shall be multiplied by [**]
percent ([**]%) and then the product of such multiplication shall be treated as
Net Sales of Product in accordance with Section 6.3. After Xxxxxx has been paid
its royalty on such Net Sales of Product in accordance with Section 6.3, then
CTI shall be entitled to the remainder of the recovery.
10.4 Claimed Infringement. In the event that a Party becomes aware
of any claim that the manufacture, use or sale of the Product by CTI infringes
the intellectual property rights of any Third Party, such Party shall promptly
notify the other Party. In any such instance, the Parties shall cooperate and
shall mutually agree upon an appropriate course of action. Each Party shall
provide to the other Party copies of any notices it receives from third parties
regarding any alleged infringement of Third Party intellectual property rights
and/or any declaratory judgment actions. Such notices shall be provided
promptly, but in no event after more than fifteen (15) days following receipt
thereof.
10.5 Patent Invalidity Claim. If a Third Party at any time asserts
a claim that any Patent Right is invalid or otherwise unenforceable (an
"Invalidity Claim"), whether as a defense in an infringement action brought by
CTI or Xxxxxx pursuant to Section 10.3 or in an action brought against CTI or
Xxxxxx under Section 10.4, the Parties shall cooperate with each other in
preparing and formulating a response to such Invalidity Claim. Neither Party
shall settle or compromise any Invalidity Claim without the consent of the other
Party, which consent shall not be unreasonably withheld.
10.6 Patent Marking. CTI agrees to comply with the patent marking
statutes in each country in which Products are sold by CTI, its Affiliates,
sublicensees and/or distributors.
11. INDEMNIFICATION.
11.1 CTI. CTI agrees to defend Xxxxxx and its Affiliates at its
cost and expense, and will indemnify and hold Xxxxxx and its Affiliates and
their respective directors, officers, employees and agents (the "Xxxxxx
Indemnified Parties") harmless from and against any losses, costs, damages, fees
or expenses arising out of any Third Party claim relating to (i) any breach by
CTI of any of its representations, warranties or obligations pursuant to this
Agreement or (ii) personal injury from the development, manufacture, use, sale
or other disposition of Product by CTI, its Affiliates and/or sublicensees. In
the event of any such claim against the Xxxxxx Indemnified Parties by any Third
Party, Abbot shall promptly notify CTI in writing of the claim and CTI shall
manage and control, at its sole expense, the defense of the claim and its
settlement. The Xxxxxx Indemnified Parties shall cooperate with CTI and may, at
their option and expense, be represented in any such action or proceeding. CTI
shall not be liable for any litigation costs
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or expenses incurred by the Xxxxxx Indemnified Parties without CTI's prior
written authorization. In addition, CTI shall not be responsible for the
indemnification of any Xxxxxx Indemnified Party arising from any negligent or
intentional acts by such Party, or as the result of any settlement or compromise
by the Xxxxxx Indemnified Parties without CTI's prior written consent.
11.2 Xxxxxx. Xxxxxx agrees to defend CTI and its Affiliates at its
cost and expense, and will indemnify and hold CTI and its Affiliates and their
respective directors, officers, employees and agents (the "CTI Indemnified
Parties") harmless from and against any losses, costs, damages, fees or expenses
arising out of any Third Party claim relating to (i) any breach by Xxxxxx of any
of its representations, warranties or obligations pursuant to this Agreement or
(ii) personal injury from the development, manufacture, use, sale or other
disposition of Compound by Xxxxxx, its Affiliates, licensees or collaborators.
In the event of any such claim against the CTI Indemnified Parties by any Third
Party, CTI shall promptly notify Xxxxxx in writing of the claim and Xxxxxx shall
manage and control, at its sole expense, the defense of the claim and its
settlement. The CTI Indemnified Parties shall cooperate with Xxxxxx and may, at
their option and expense, be represented in any such action or proceeding.
Xxxxxx shall not be liable for any litigation costs or expenses incurred by the
CTI Indemnified Parties without Xxxxxx prior written authorization. In addition,
Xxxxxx shall not be responsible for the indemnification of any CTI Indemnified
Party arising from any negligent or intentional acts by such Party, or as the
result of any settlement or compromise by the CTI Indemnified Parties without
Xxxxxx prior written consent.
11.3 Insurance. Each Party shall, at its sole cost and expense,
obtain and keep in force general liability insurance with product liability
limits of Seven Million Five Hundred Thousand U.S. Dollars (U.S. $7,500,000) in
the aggregate and general liability, including, without limitation coverage for
bodily injury, death and property damage, limits of One Million US. Dollars
(U.S. $1,000,000) in the aggregate. Within thirty (30) days after the Effective
Date, each Party shall furnish to the other a certificate of insurance
evidencing the insurance coverage required by this Agreement and providing for
at least ten (10) days prior written notice to the other Party of any
cancellation, termination, material change or reduction of such insurance
coverage. During the Term, either Party may self-insure regarding the insurance
requirements in accordance with this Section, provided such Party maintains a
net worth as measured by its retained earnings in the amount of Five Hundred
Million U.S. Dollars (U.S. $500,000,000).
12. TERMINATION.
12.1 Term. This Agreement shall be effective as of the Effective
Date and shall remain in effect unless terminated pursuant to Section 12.3 below
("Term").
12.2 Survival of Licenses. Upon the expiration of CTI's obligations
to pay royalties to Xxxxxx under Section 6.4 with respect to Product in each
country, the licenses set forth in Article 2 shall be deemed to be perpetual,
irrevocable and fully-paid up with respect to Product in such country.
12.3 Termination.
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(a) CTI shall have the right to terminate this Agreement
at any time upon sixty (60) days written notice to Xxxxxx in CTI's sole and
absolute discretion, provided that CTI shall pay Xxxxxx Four Million United
States Dollars ($4,000,000) (the "Termination Fee"), less the License Fee and
any milestone payments that CTI has already made to Xxxxxx in accordance with
Section 6.2. In the event that CTI has paid Xxxxxx Four Million United States
Dollars ($4,000,000) or more in payment of the License Fee and in milestone
payments in accordance with Section 6.2, then CTI shall not owe Xxxxxx the
Termination Fee in accordance with this paragraph 12.3(a).
(b) Either Party may terminate this Agreement by giving
to the other Party prior written notice of not less than sixty (60) days in the
case of a material breach of this Agreement, and such breaching Party shall fail
to cure, or commence action to cure, such breach during such sixty (60) day
period. In the event of a dispute as to whether a material breach has occurred,
the existence of material breach shall be determined using the ADR procedure set
forth in Section 13.8 and Exhibit A. A Party's right to terminate this Agreement
shall only apply if the breaching Party fails to cure such breach in the manner
required by the final judgment of the ADR hearing within sixty (60) days after
that judgment is rendered.
12.4 Effect of Termination. Upon termination of this Agreement
pursuant to Section 12.3:
(a) In the event that such termination is by Xxxxxx
pursuant to Section 12.3(b) or by CTI pursuant to Section 12.3(a), then all
licenses granted to CTI shall immediately terminate and CTI shall assign to
Xxxxxx all of its right, title and interest in and to all regulatory filings and
Regulatory Approvals relating to Product; or
(b) In the event that such termination is by CTI for a
material breach of this Agreement by Xxxxxx, then the rights of Xxxxxx under
Section 2.4 shall immediately terminate and all licenses set forth in Section
2.1, 2.2 and 2.3 shall continue in effect. In addition, CTI's financial
obligations set forth in Section 6.3 shall remain in effect and survive such
termination.
12.5 Survival. Upon termination of this Agreement for any reason,
nothing in this Agreement shall be construed to release either Party from any
obligations that matured prior to the effective date of expiration or
termination; and Sections 12.2, 12.4 and this Section 12.5 and the following
provisions shall expressly survive any such expiration or termination: Article
1, Article 2 (to the extent provided in Section 12.4), Article 6 (to the extent
additional amounts are to be paid to Xxxxxx in accordance with paragraph 12.3(a)
or paragraph 12.4(b )), Article 9, Article 11 and Article 13.
13. MISCELLANEOUS.
13.1 Notices. Any notice required or permitted to be given or made
under this Agreement by one of the Parties to the other shall be in writing,
delivered by facsimile (and promptly confirmed by personal delivery, first-class
mail U.S. or courier), addressed to such other Party at its address and
facsimile number indicated below, or to such other address and facsimile as the
addressee shall have last furnished in writing to the addressor and (except as
otherwise provided in this Agreement) shall be effective upon the date on which
the facsimile is sent by the notifying Party.
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If to CTI: Critical Therapeutics, Inc.
000 Xxxxxxxxxxxxx Xxxxxx
00xx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Executive Officer
FACSIMILE: 000-000-0000
with a copy to:
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
FACSIMILE: 617-526-5000
If to Xxxxxx: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxx. X000; Xxxx. XX0-0
Xxxxxx Xxxx, Xxxxxxxx 00000
Attention: Xxxx X. Xxxxxxx, MD
FACSIMILE: 000-000-0000
with a copy to:
Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxx. 364; Bldg. AP6D
Xxxxxx Xxxx, Xxxxxxxx 00000
Attention: Senior Vice President,
Secretary and General Counsel
FACSIMILE: 000-000-0000
13.2 Applicable Law. This Agreement shall be governed by and
construed in accordance with the laws of the State of Illinois, excluding its
conflict of laws provisions.
13.3 Entire Agreement. Subject to the confidentiality obligations
contained in that certain Bilateral Confidentiality Disclosure Agreement dated
March 5, 2003 between Xxxxxx and CTI and that certain Bilateral Confidentiality
Disclosure Agreement dated August 27, 2002 between Xxxxxx and CTI's agent,
Pleiades Consultation, Inc., an Arizona corporation, this Agreement contains the
entire understanding of the Parties with respect to the subject matter hereof.
All other express or implied agreements and understandings, either oral or
written, heretofore made are expressly superseded by this Agreement. This
Agreement may be amended, or any term hereof modified, only by a written
instrument duly executed by both Parties.
13.4 Counterparts. This Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement may be
executed by facsimiles of the Parties' signatures
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provided the facsimile counterpart signature pages are promptly followed by the
original signature pages by overnight delivery in accordance with Section 13.1.
13.5 Severability. If any provision of this Agreement is deemed
unenforceable, the remainder of the Agreement will not be affected and, if
appropriate, the Parties will attempt to replace the unenforceable provision
with a new provision that, to the extent possible, reflects the Parties'
original intent.
13.6 Schedules/Exhibits. All Schedules and Exhibits attached hereto
are incorporated herein by this reference as if fully set forth herein.
13.7 Assignment. Except as expressly provided herein, this
Agreement and any documents executed in connection herewith shall not be
assigned by operation of law or otherwise by CTI without the prior written
consent of Xxxxxx, which consent shall not be unreasonably withheld, and any
assignment without such prior written consent shall be null and void. Xxxxxx
shall notify CTI in writing of its determination to grant or withhold such
consent ("Xxxxxx Notice") within sixty (60) days of the date of CTI' s notice to
Xxxxxx of the proposed assignment of this Agreement. In the absence of such
Xxxxxx Notice within such sixty-day period, consent shall be deemed to have been
granted by Xxxxxx for purposes of this Section 13.7. Notwithstanding the
foregoing, CTI may make such assignment without Xxxxxx'x consent in connection
with a sale of all or substantially all of the business and assets of CTI to
which the subject matter of this Agreement pertains ("change of control"), to
any health care company or group of companies acting in concert for whom
collective worldwide sales of pharmaceutical products in a calendar year that
preceded the change of control were [**] dollars (US$[**]) or less and provided
that CTI provides Xxxxxx with reasonable prior written notice of such
assignment, including, without limitation, documentation to support such
assignee's sales and copies of the assignment and assumption agreement.
13.8 Dispute Resolution. The Parties shall attempt to settle any
dispute arising out of or relating to this Agreement in an amicable way. Any
controversy, claim or right of termination for cause which may arise under, out
of, in connection with, or relating to this Agreement, or any breach thereof,
shall be settled according to the Alternative Dispute Resolution provisions
attached hereto as Exhibit A.
13.9 Independent Contractor. Subject to the terms and provisions of
this Agreement, it is understood that both Parties are independent contractors
and engage in the operation of their own respective businesses and neither Party
is to be considered the agent of the other Party for any purpose whatsoever and
neither Party has any authority to enter into any contract or assume any
obligation for the other Party or to make any warranty or representation on
behalf of the other Party. Each Party shall be fully responsible for its own
employees, servants and agents, and the employees, servants and agents of one
Party shall not be deemed to be employees, servants and agents of the other
Party for any purpose whatsoever.
13.10 Publicity. Within five (5) days of the Effective Date, the
Parties shall jointly issue a press release in the exact form set forth in
Exhibit B attached hereto ("Press Release"). Subject to Article 9, each of the
Parties acknowledges that, other than the Press Release, neither the signing of
this Agreement nor the relationship of the Parties under this Agreement requires
a
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press release to be issued, or any other form of public disclosure to be made,
by either Party under any applicable law or requirement, including but not
limited to any requirement of securities law or any stock exchange or market.
Other than the Press Release, neither Party shall issue any press release or any
other form of public disclosure regarding this Agreement or the relationship of
the Parties under this Agreement or use the name of the other Party in any press
release or other publicity ("Agreement Publicity") following the Effective Date,
except as required by a mandatory provision of applicable law and solely to the
extent necessary to comply with such provision of law.
In the event either Party reaches the conclusion that Agreement Publicity is
required after the Effective Date, such party shall inform the other Party of
its conclusion and provide the other Party with the opportunity to review the
Agreement Publicity and the necessity of making the Agreement Publicity at least
ten (10) business days prior to the planned release of the Agreement Publicity
and agrees to take such other Party's input and opinion seriously into account
before releasing the Agreement Publicity.
The Parties acknowledge that either Party's failure to meet the requirements of
this Section 13.10 shall constitute a material breach of this Agreement, giving
the other Party the right, if such breach is not cured within the applicable
cure period, to terminate this Agreement pursuant to Section 12.3(b) hereof.
13.11 Day of Performance. If any date for performance hereunder
falls on a Saturday, Sunday or other day which is a holiday under Federal law or
the State of Illinois, the date for such performance shall be the next
succeeding business day.
13.12 No Consequential Damages. UNLESS RESULTING FROM A PARTY'S
WILLFUL MISCONDUCT OR FROM A PARTY'S BREACH OF ARTICLE VI, NEITHER PARTY HERETO
WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE,
MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE
OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE
DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT WHETHER BASED
XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX LIABILITY OR OTHERWISE, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 13.12 IS INTENDED TO LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS
AGREEMENT.
13.13 Force Majeure. Neither Party shall be held liable to the other
Party nor be deemed to have defaulted under or breached the Agreement for
failure or delay in performing any obligation under the Agreement (except for a
Party's requirement to pay amounts due to the other Party in accordance with
this Agreement) when such failure or delay is caused by or results from causes
beyond the reasonable control of the affected Party including, but not limited
to, embargoes, war, acts of war (whether war be declared or not), insurrections,
riots, civil commotions, strikes, lockouts or other labor disturbances, fire,
floods, or other acts of God, or acts, omissions or delays in acting by any
governmental authority or the other Party. The affected Party shall notify the
other Party of such force majeure circumstances as soon as
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reasonably practical, and shall promptly undertake all reasonable efforts
necessary to cure such force majeure circumstances.
13.14 Exports. CTI acknowledges that the export of technical data,
materials or products is subject to the exporting party receiving any necessary
export authorizations, approvals, permits, licenses and consents from the Bureau
of Industry and Security, and other applicable U.S. government agencies. CTI
agrees not to export or re-export, directly or indirectly, any information,
know-how, technical data, the direct product of such data, samples or product
received or generated under this Agreement in violation of any applicable U.S.
export control laws or governmental regulations. CTI agrees to obtain similar
covenants from its licensees or sublicensees, as the case may be, with respect
to the subject matter of this Section 13.14.
[REMAINDER OF THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK.]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day first
at written.
XXXXXX LABORATORIES CRITICAL THERAPEUTICS, INC.
an Illinois corporation a Delaware corporation
By: /s Xxxxxxx X. Leiden By: /s/ Xxxxxx Xxxxxxxx
------------------------------------------ ---------------------------
Name: Xxxxxxx M Leiden, MD, PhD Name: Xxxxxx Xxxxxxxx
Title: President and Chief Operating Officer, Title: Chief Operating Officer
Pharmaceutical Products Group
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SCHEDULE 1
(Patents)
COUNTRY PATENT NO. ISSUE DATE EXPIRATION DATE
Australia 608,804 2 September 1991 9 February 0000
Xxxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxx XX 0000000-0 18 May 1999 10 February 0000
Xxxxxx 1,327,204 22 February 1994 22 February 0000
Xxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxx 279,263 4 August 1993 1 February 0000
Xxxxx 279,263 4 August 1993 1 February 0000
Xxxxx 1,862,133 8 August 1994 10 February 2008
Korea 103,306 12 August 1996 16 April 0000
Xxxxxx 179,410 30 August 1995 10 October 0000
Xxxxxxxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxxxxx 0000000-0 15 May 1997 1 February 0000
Xxxxx 279,263 4 August 1993 1 February 0000
Xxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxxxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxx Xxxxxxx 279,263 4 August 1993 1 February 0000
Xxxxxx Xxxxxx 4,873,259 10 October 1989 10 December 2010
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SCHEDULE 2
(Technology Transfer)
THIRD PARTY MANUFACTURING (TPM) OF API PHASE IT PROCESS AND CR PRODUCT
FORMULATION
THE TECHNOLOGY TRANSFER PROCESS WILL BE INITIATED WITHIN [**] OF THE AGREEMENT
BEING SIGNED ("AGREED-TO START DATE") BETWEEN XXXXXX LABORATORIES (ABBOTT) AND
CRITICAL THERAPEUTICS INC. (CTI)
ABBOTT SHOULD PROVIDE COMMERCIALLY REASONABLE ASSISTANCE TO FACILITATE THE
TECHNOLOGY TRANSFER TO CTI AND TO CTI APPOINTED TPM OF THE API, RHODIA PHARMA
SOLUTIONS (RPS), AND TO THE TPM OF THE CR FORMULATION, SKYE PHARMA AG (SKP)
API TRANSFER OF TECHNOLOGY
THE TECHNOLOGY TRANSFER OF THE API WILL BE COMPLETED WITHIN [**] OF THE
AGREED-TO-START DATE.
ABBOTT WILL USE COMMERCIALLY REASONABLE EFFORTS TO PROVIDE THE MATERIALS,
DOCUMENTS, DATA AND REPORTS REQUESTED FOR THE TECHNOLOGY TRANSFER AND TO ANSWER
QUESTIONS RAISED BY CTI AND THE APPOINTED TPM, RPS, DURING THAT PERIOD. A
MEETING WILL BE SCHEDULED BETWEEN CTI AND THE APPOINTED TPM, RPS, AND ABBOTT
TECHNICAL STAFF AT A DATE AGREED UPON BY THE PARTIES
o MATERIALS, DOCUMENTS, DATA AND REPORTS (API)
o Reference standards, as available, at Abbott for the Phase II bulk and
impurities: [**]
o Phase II bulk drug: 3 lots of Phase II bulk expired, to be used for
development work
- [**]
- [**]
- [**]
o Access to the relevant original zileuton IR NDA 20-471 documents to
support changes in API manufacturing process and changes of
manufacturing
o Batch records for optimized Phase II process batches. Per Abbott QA
policy, either copies will be provided or CTI will be given access to
review.
o Validation report for Phase II process
o Microbial data for Phase II batches
o Validation data for microbiological tests
o Stability program: forced degradation data
o Details of relevant critical process parameters
o Environmental: detailed mass balance/info on composition of waste
streams
o [**]
o availability of technical staff to answer specific questions in the
form of conference call, correspondence or other means agreed by the
parties
LIST OF REFERENCE STANDARDS AVAILABLE FROM ABBOTT
PARENT
CAT. NO. TYPE DESCRIPTION
[**]
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[**]
CAT NO. TYPE DESCRIPTION
[**]
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CR FORMULATION PRODUCT TRANSFER OF TECHNOLOGY
THE TECHNOLOGY TRANSFER OF THE CR PRODUCT WILL BE COMPLETED WITHIN [**] OF THE
AGREED-TO-START DATE.
ABBOTT WILL USE COMMERCIALLY REASONABLE EFFORTS TO PROVIDE THE MATERIALS,
DOCUMENTS, DATA AND REPORTS REQUESTED FOR THE TECHNOLOGY TRANSFER AND TO ANSWER
QUESTIONS RAISED BY CTI AND THE APPOINTED TPM, SKP, DURING THAT PERIOD. A
MEETING WILL BE SCHEDULED BETWEEN CTI AND THE APPOINTED TPM, SKP, AND ABBOTT
TECHNICAL STAFF AT A DATE AGREED UPON BY THE PARTIES
o MATERIALS, DOCUMENTS, DATA AND REPORTS (CR PRODUCT)
o As available, samples of CR tablets from the production scale batches
([**]) and other production batches ([**])
o batch records from production scale batches mentioned above
o validation report [[**]]
o MSDS [already provided]
o Friability: copy of packaging and shipping studies
o Statistical analyses from the 12 months stability report [**]
o Full report from genotoxicity studies with CR degradant [**]
o Copies of the relevant original zileuton IR NDA 20-471 documents and
zileuton CR IND 47,561 to support changes in manufacturing site of the
CR product and submit an NDA for zileuton CR in asthma
o Transfer database for Phase III clinical Trials Zileuton CR Product
- M95-337: Phase III pivotal Study
- M96-464: Long-Term Safety study
- Statistical Analyses
- Full reports including Appendices and Protocols, if not already
available
- CRFs and all relevant source documents from investigators
o Transfer database (safety and PK) for Biopharmaceutics Studies
- M95-266
- M95-262
- M96-556
- M97-742
- Full Clinical and Drug Metabolism reports, including Appendices
and Protocols, if not already available
- CRFs and all relevant source documents
o Analytical procedure for zileuton in plasma samples
o Copy of full CR IND 47,561 submission and Amendments, if not already
provided
o FDA communications and reports of serious AEs, if not already provided
o Detailed post-marketing safety data! reports on Zyflo, specially
regarding hepatic events
o Copy of all relevant patents as listed in Schedule 1
Availability of technical staff to answer specific questions in the form of
conference call, correspondence or other means agreed by the Parties
Execution Copy
EXHIBIT A
(Alternative Dispute Resolution)
The Parties recognize that from time to time a dispute may arise
relating to either Party's right or obligations under this Agreement. The
Parties agree that any such dispute shall be resolved by the Alternative Dispute
Resolution ("ADR") provisions set forth in this Exhibit, the result of which
shall be binding upon the Parties.
To begin the ADR process, a Party first must send written notice of the
dispute to the other Party for attempted resolution by good faith negotiations
between their respective presidents (or their designees) of the affected
subsidiaries, divisions, or business units within twenty-eight (28) days after
such notice is received (all references to "days" in this ADR provision are to
calendar days). If the matter has not been resolved within twenty-eight (28)
days of the notice of dispute, or if the Parties fail to meet within such
twenty-eight (28) days, either Party may initiate an ADR proceeding as provided
herein. The Parties shall have the right to be represented by counsel in such a
proceeding.
1. To begin an ADR proceeding, a Party shall provide written notice to the
other Party of the issues to be resolved by ADR. Within fourteen (14)
days after its receipt of such notice, the other Party may, by written
notice to the Party initiating the ADR, add additional issues to be
resolved within the same ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the Parties shall select a mutually acceptable neutral to
preside in the resolution of any disputes in this ADR proceeding. If
the Parties are unable to agree on a mutually acceptable neutral within
such period, either party may request the President of the CPR
Institute for Dispute Resolution ("CPR"), 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to select a neutral pursuant to the
following procedures:
(a) The CPR shall submit to the Parties a list of not less than
five (5) candidates within fourteen (14) days after receipt of
the request, along with a Curriculum Vitae for each candidate.
No candidate shall be an employee, director, or shareholder of
either Party or any of their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
impartiality.
(c) Each Party shall number the candidates in order of preference
(with the number one (1) signifying the greatest preference)
and shall deliver the list to the CPR within seven (7) days
following receipt of the list of candidates. If a Party
believes a conflict of interest exists regarding any of the
candidates, that Party shall provide a written explanation of
the conflict to the CPR along with its list showing its order
of preference for the candidates. Any Party failing to return
a list of preferences on time shall be deemed to have no order
of preference.
(d) If the Parties collectively have identified fewer than three
(3) candidates deemed to have conflicts, the CPR immediately
shall designate as the neutral the
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candidate for whom the parties collectively have indicated the
greatest preference. If a tie should result between two
candidates, the CPR may designate either candidate. If the
Parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the
explanations regarding conflicts and, in its sole discretion,
may either (i) immediately designate as the neutral the
candidate for whom the Parties collectively have indicated the
greatest preference, or (ii) issue a new list of not less than
five (5) candidates, in which case the procedures set forth in
subparagraphs 2(a) -2(d) shall be repeated.
3. No earlier than twenty-eight (28) days or later than fifty-six (56)
days after selection, the neutral shall hold a hearing to resolve each
of the issues identified by the Parties. The ADR proceeding shall take
place at a location agreed upon by the Parties. If the Parties cannot
agree, the neutral shall designate a location other than the principal
place of business of either Party or any of their subsidiaries or
affiliates.
4. At least seven (7) days prior to the hearing, each Party shall submit
the following to the other Party and the neutral:
(a) a copy of all exhibits on which such Party intends to rely in
any oral or written presentations to the neutral;
(b) a list of any witnesses such Party intends to call at the
hearing, and a short summary of the anticipated testimony of
each witness;
(c) a proposed ruling on each issue to be resolved, together with
a request for a specific damage award or other remedy for each
issue. The proposed rulings and remedies shall not contain any
recitation of the facts or any legal arguments and shall not
exceed one (1) page per issue.
(d) a brief in support of such Party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20)
pages. This page limitation shall apply regardless of the
number of issues raised in the ADR proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d), no
discovery shall be required or permitted by any means, including
depositions, interrogatories, requests for admissions, or production of
documents.
5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each Party shall be entitled to five (5) hours of hearing time
to present its case. The neutral shall determine whether each
Party has had the five (5) hours to which it is entitled.
(b) Each Party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony,
documents or other evidence, to cross-examine witnesses, and
to make a closing argument. Cross-examination of witnesses
shall occur immediately after their direct testimony, and
cross-
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examination time shall be charged against the Party conducting
the cross-examination.
(c) The party initiating the ADR shall begin the hearing and, if
it chooses to make an opening statement, shall address not
only issues it raised but also any issues raised by the
responding party. The responding party, if it chooses to make
an opening statement, also shall address all issues raised in
the ADR. Thereafter, the presentation of regular and rebuttal
testimony and documents, other evidence, and closing arguments
shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the
hearing until closing arguments.
(e) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances.
Affidavits prepared for purposes of the ADR hearing also shall
not be admissible. As to all other matters, the neutral shall
have sole discretion regarding the admissibility of any
evidence.
6. Within seven (7) days following completion of the hearing, each Party
may submit to the other Party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief
shall not contain or discuss any new evidence and shall not exceed ten
(10) pages. This page limitation shall apply regardless of the number
of issues raised in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the Parties on each
disputed issue but may adopt one Party's proposed rulings and remedies
on some issues and the other Party's proposed rulings and remedies on
other issues. The neutral shall not issue any written opinion or
otherwise explain the basis of the ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of the
prevailing Party (including all expert witness fees and expenses), the
fees and expenses of a court reporter, and any expenses for a hearing
room, shall be paid as follows:
(a) If the neutral rules in favor of one Party on all disputed
issues in the ADR, the losing Party shall pay 100% of such
fees and expenses.
(b) If the neutral rules in favor of one Party on some issues and
the other Party on other issues, the neutral shall issue with
the rulings a written determination as to how such fees and
expenses shall be allocated between the Parties. The neutral
shall allocate fees and expenses in a way that bears a
reasonable relationship to the outcome of the ADR, with the
Party prevailing on more issues, or on issues of greater value
or gravity, recovering a relatively larger share of its legal
fees and expenses.
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9. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non-appealable, and may be
entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and
briefs), and the rulings shall be deemed Confidential Information. The
neutral shall have the authority to impose sanctions for unauthorized
disclosure of Confidential Information.
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Exhibit B (form of press release)
[Critical Therapeutics logo]
CONFIDENTIAL DRAFT
Contact:
Xxxxxx Xxxxxxxx, Ph.D. or Xxxxx Xxxxxxx
Vice President of Operations Vice President
Critical Therapeutics, Inc. Xxxxxx Xxxxxxx Associates, Inc.
617.354.9311 x226 617.542.5300
xxxxxxxxx@xxxxxxxxxxxxxxxxxxxx.xxx xxxxxxxx@xxxxxxxxxxxxxxxxx.xxx
CRITICAL THERAPEUTICS IN-LICENSES ASTHMA DRUG PROGRAM
FROM XXXXXX LABORATORIES
CAMBRIDGE, MASS., DECEMBER XX, 2003 - Critical Therapeutics, Inc., a privately
held biopharmaceutical company engaged in the discovery and development of
products for critical care medicine, today announced that it has in-licensed
certain rights to both controlled release and intravenous formulations of
zileuton.
Critical Therapeutics plans to develop a controlled-release formulation of
zileuton, which would allow for less frequent dosing. Xxxxxx'x immediate release
formulation of the drug (Zyflo filmtab(R), zileuton tablets) received marketing
approval from the US. Food and Drug Administration (FDA) in December 1996, and
is used for the prevention and continuous treatment of asthma in patients 12 and
older. Zyflo filmtab is not part of this agreement.
"As a drug designed to block a key mediator of inflammation, zileuton directly
complements our cytokine-focused product platform," said Xxxx X. Xxxxx, M.D.,
Critical Therapeutics' president and chief executive officer. "We are very
excited about adding zileuton to our product pipeline."
Under the agreement, Critical Therapeutics will assume all regulatory,
manufacturing and marketing responsibility for the controlled-release and
intravenous formulations of zileuton. Abbott will receive milestone and royalty
payments based on product sales. The companies did not disclose financial terms
of the agreement.
Zileuton belongs to a class of drugs known as 5-lipoxygenase (5-LO) inhibitors.
The drug inhibits the production of molecules called leukotrienes, which
contribute to conditions present in and around the airways of asthma patients.
These conditions include swelling, bronchoconstriction and mucus secretion. Xx.
Xxxxx oversaw the work on Zileuton while supervising global clinical and
pre-clinical development at Abbott from 1987 to 1993.
"This agreement provides us with the potential of near-term revenue from a
product that has already completed a Phase III program. While an
immediate-release, four times a day formulation of zileuton has been previously
approved and is available on the market, our goals for controlled release
zileuton are far greater," Xx. Xxxxx said. "Based on the clinical results
demonstrated in unpublished studies on the product, we see an opportunity to
broaden the use of
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CTI - ZILEUTON/2
zileuton through new indications and new formulations. From a cost-benefit
perspective, our licensing agreement with Abbott is the ideal mechanism for both
companies to realize an excellent return from this initiative."
Asthma affects approximately 20.3 million Americans, according to the American
Academy of Asthma Allergy & Immunology. Direct health care costs for the disease
exceed, $8.1 billion annually, with pharmaceuticals representing the largest
share of those costs.
SAFETY INFORMATION
Zyflo Filmtab(R) (zileuton tablets) is not for use in the reversal of acute
asthma attacks.
Patients with active liver disease should not take Zyflo. Liver function tests
are recommended prior to and during treatment with Zyflo.
When taking Zyflo, theophylline dose should be reduced by 50% and appropriately
monitored; patients taking propranolol or warfarin should be monitored and doses
adjusted if necessary.
The only adverse event reported significantly more often by Zyflo patients than
placebo-treated patients was upset stomach (8.2% vs. 2.9%, respectively).
Further information regarding Zyflo, including full prescribing information, is
available from Xxxxxx Medical Information by calling 000-000-0000.
CRITICAL THERAPEUTICS
Critical Therapeutics, Inc. is a privately held biopharmaceutical company
focused on critical care medicine. CTI's mission is the discovery, development
and commercialization of novel therapies for the treatment of acute trauma,
cardiopulmonary disease and infectious and inflammatory illness. The Company's
current research and development portfolio includes HMGB-l, a pro-inflammatory
substance identified as a mediator of TNF-associated tissue damage; development
of small molecule and vagal nerve stimulation approaches to treat inflammation;
and CTI-0l, a proprietary anti-inflammatory drug candidate currently in Phase I
clinical trials. The Company is headquartered in Cambridge, Massachusetts. More
information about CTI is available at xxx.xxxxxxxxxxxxxxxxxxxx.xxx
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