Exhibit 10.11
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
LICENSE AGREEMENT
This License Agreement (the "Agreement") is made as of this 17th day of
March, 2004 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, Know How and Trademark 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 (as hereinafter
defined) in the Field in order to permit CTI to pursue the marketing,
distribution, sale and commercialization of the Product in the Field; and
3. CTI wishes to purchase, and Abbott wishes to sell to CTI, all right,
title and interest in and to the Trademark and the goodwill associated
therewith.
NOW THEREFORE, in consideration of the mutual obligations and promises as
set forth herein, Abbott and CTI do hereby agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms shall have the
following respective meanings:
1.1 "Abbott Products" shall mean those Products, including Existing
Products, that have an assigned NDC Code that corresponds to the Original NDA,
as listed by Abbott with the FDA under section 510 of the Act; provided,
however, that Abbott Products shall exclude any Existing Product that has been
relabeled by CTI under Section 3.2(b) hereof.
1.2 "Act" shall mean the United States Food, Drug, and Cosmetic Act, as
amended, and regulations promulgated thereunder.
1.3 "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).
1.4 "cGMP" shall mean the current Good Manufacturing Practices, under 21
CFR Parts 210 and 211, applicable to the manufacturing, processing, packing or
holding of pharmaceutical products in the United States of America.
1.5 "Commercially Reasonable Efforts" shall mean with respect to the
efforts to be
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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 (as applicable to
CTI) or a large pharmaceutical company (as applicable to Abbott) 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 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 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.
1.6 "Confidential Information" shall mean any information, data or
business plans relating to Zyflo, 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, 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 by a Party or a Third Party, or becomes
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.
1.7 "DDMAC" shall mean the FDA Center for Drug Evaluation and Research,
Office of Medical Policy, Division of Drug Marketing, Advertising and
Communications.
1.8 "Effective Date" shall mean the date of this Agreement set forth in
the opening paragraph hereof.
1.9 "Existing Product" shall mean all Products remaining in Xxxxxx'x
inventory as of the Effective Date, totaling approximately [**] tablets of
Product.
1.10 "FDA" shall mean the United States Food and Drug Administration.
1.11 "Field" shall mean research, diagnostics, therapeutics, and services
for all human medical conditions or diseases.
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1.12 "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.
1.13 "IND" shall mean any Investigational New Drug Application and any
amendments thereto filed with the FDA.
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 relating to the use of the Product in the Field.
1.15 "Manufacturing Cost" shall mean the standard cost per unit of
Existing Product, including the cost of raw materials, labor and other direct
and identifiable variable costs and appropriate costs for equipment, tools,
plant operations and plant support services.
1.16 "NDA" shall mean a New Drug Application, and all supplements and
amendments thereto filed with the FDA, for a Product.
1.17 "NDC Code" shall mean the National Drug Code for a Product assigned
to each drug product listed under section 510 of the Act.
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 or other disposition 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
(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
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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 "Original IND" shall have the meaning set forth in Section 3.1(b).
1.20 "Original NDA" shall have the meaning set forth in Section 3.1(b).
1.21 "Party" shall mean Abbott or CTI, as appropriate in the context, and
"Parties" shall mean Abbott and CTI, collectively.
1.22 "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).
1.23 "Product" shall mean any pharmaceutical product which incorporates
Zyflo or an immediate release formulation of the compound Zileuton for use in
the Field in the Territory, and (a) use of which by CTI, an Affiliate or
sublicensee 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
hereunder, or (b) embodies Know-How.
1.24 "Regulatory Approval" shall mean the approval to sell Product granted
by any
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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.
1.25 "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.
1.26 "Safety Data Agreement" shall have the meaning set forth in Section
4.2 hereof.
1.27 "Specifications" shall mean the specifications as of the Effective
Date for the finished dosage form, drug substance and other ingredients and
components, and the manufacture, packaging and labeling of the Existing Product
consistent with the Original NDA.
1.28 "Term" shall have the meaning set forth in Section 12.1 hereof.
1.29 "Territory" shall mean the entire world.
1.30 "Third Party" shall mean any entity other than Abbott and its
Affiliates or CTI and its Affiliates.
1.31 "Trademark" shall mean the xxxx ZYFLO and any and all registrations
thereof.
1.32 "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.
1.33 "Zyflo" shall mean the immediate release formulation of the compound
Zileuton for which Abbott has obtained FDA approval and is exemplified by the
product that is marketed as of the Effective Date within the United States by
the trade name Zyflo.
2. LICENSE GRANTS; TRADEMARK ASSIGNMENT.
2.1 Exclusive License. Subject to Section 12.4, 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 for use in the
Field.
2.2 Trademark Assignment.
(a) Subject to the terms and conditions of this Agreement, Abbott hereby
irrevocably and unconditionally sells, transfers, conveys, assigns and delivers
to CTI, and CTI hereby purchases from Abbott, all right, title and interest in
and to the Trademark and the goodwill associated therewith. The assignment of
the Trademark from Abbott to CTI hereunder shall be evidenced by a
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Trademark Assignment, in the form attached hereto as Exhibit B ("Trademark
Assignment"). Concurrently with the execution of this Agreement, Abbott shall
execute and have notarized the Trademark Assignment for filing by CTI with the
U.S. Patent and Trademark Office.
(b) Abbott agrees that following the Effective Date, it will abandon all
use of the Trademark. Notwithstanding anything to the contrary in this
Agreement, Abbott reserves, and CTI hereby grants to Abbott, the exclusive,
royalty-free, worldwide and perpetual right (including the right to sublicense
or assign such right) to use the Trademark in connection with the manufacture,
packaging, labeling, promotion, marketing, offer of sale, sale and import of
products containing Zileuton and/or services related thereto for research,
diagnostics, therapeutics and services relating to humans aged seven (7) years
and under ("Pediatric Use"), except that such right shall be co-exclusive solely
to allow CTI to promote, market, offer to sell, sell and import Zyflo pursuant
to this Agreement without restriction as to patient user age and without
specific promotion for Pediatric Use. Abbott shall maintain the quality of its
products and services that are identified by the Trademark by (1) adhering to
those specific quality control standards that are at least as high as similar
pharmaceutical products sold by Abbott; (2) permitting CTI's authorized
personnel to enter Xxxxxx'x premises at reasonable times, upon 48 hours notice
no more than one time per year, to inspect Xxxxxx'x facilities and operations in
order to ensure that Abbott is using the Trademark in compliance with this
Agreement; and (3) not modifying the Trademark in any way and not using the
Trademark on any products or services other than as set forth in this Agreement.
If Abbott fails to use the Trademark in compliance with this provision, CTI may
terminate the license granted to Abbott under this Section 2.2(b) upon ninety
(90) days prior written notice if Abbott has not cured such failure within such
90-day period and if such failure to cure is not due to circumstances beyond the
control of Abbott.
(c) Abbott further agrees to execute any other document and take any
further action reasonably requested by CTI to effectuate the intent and purpose
of this Section 2.2.
2.3 Right to Sublicense. CTI shall have the right to grant sub-licenses to
the rights granted under Section 2.1. 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 and, upon request from Abbott, provide an
appropriately redacted copy of such 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.
Notwithstanding the foregoing, CTI shall not have the right to grant any
sublicense to the rights granted under Section 2.1 for the purpose of allowing
any Third Party to develop, have developed, make, have made, use, have used,
import, have imported, offer to sell, sell or have sold Product anywhere in the
Territory specifically for Pediatric Use.
2.4 Right to Appoint Distributors. 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.
2.5 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,
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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; NDA/IND TRANSFER; SUPPLY OF EXISTING PRODUCT.
3.1 Completion of Technology Transfer and NDA/IND Transfer.
(a) Abbott will use Commercially Reasonable Efforts to transfer knowledge
of its present technology as identified in Schedule 2 for the manufacture and
validation of Product, including Xxxxxx'x active pharmaceutical ingredient
process and the immediate release formulation data, to CTI (or a CTI designee)
to allow CTI to further develop and manufacture Product. Abbott makes no
representation, warranty or guaranty that CTI shall be able to manufacture and
validate Product.
(b) Consistent with the requirements of 21 CFR 314.72, Abbott will
transfer to CTI the NDA for Zyflo ("Original NDA"); Abbott will also transfer
the complete IND file for Zyflo ("Original IND") and all such available
documentation relevant to the Original IND and/or the Original NDA as is
necessary to enable CTI to assume regulatory responsibility for production of
Zyflo, including all records and reports required to be kept under 21 CFR Parts
210 and 211 that are necessary to enable CTI to assume such responsibility (but
excluding, for the avoidance of doubt, records of Abbott that are not so
necessary such as confidential personnel records, facility design records or
quality assurance batch records). Abbott will use Commercially Reasonable
Efforts to transfer all relevant documents and reports as identified in Schedule
2 to allow CTI to continue to commercialize Product. Notwithstanding the
foregoing, CTI shall provide Abbott a written right of reference allowing Abbott
access to and use of the NDA files for Zyflo solely for purposes of research,
development, manufacture and sale of products and services in the field of
research, diagnostics, therapeutics, and services related to the following: (i)
Pediatric Use of products containing Zileuton, and (ii) cardiovascular and
vascular devices, including, without limitation, stents.
(c) CTI will reimburse Abbott for its actual costs and expenses in the
technology transfer and NDA/IND transfer contemplated under this Section 3.1.
3.2 Supply of Existing Product.
(a) Within fifteen (15) business days of the Effective Date, Abbott shall
deliver to CTI all Existing Products. Subject to Section 7.7, CTI shall pay
Abbott the Manufacturing Cost plus [**]% of the Manufacturing Cost in respect of
Existing Products within thirty (30) days of Xxxxxx'x invoice thereof, which
invoice shall be sent to CTI concurrently with the delivery of such Existing
Products to CTI.
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(b) CTI may use the Existing Products for use in the Field in the
Territory, including for research and commercial distribution. CTI shall have
the right to relabel such Existing Products for use in clinical research in
accordance with applicable law and regulations; provided, however, that CTI
shall be responsible for Existing Products which have been relabeled by CTI.
4. FDA; SAFETY; COMPLAINTS.
4.1 CTI shall comply with all present and future laws, including, without
limitation, the 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. Abbott
shall prepare and provide to CTI for FDA submission the Original IND and
Original NDA annual reports, to the extent applicable, and Periodic Report for
the period of time during which the Original IND and Original NDA were owned by
Abbott.
4.2 Each Party warrants that it shall, from the Effective Date until the
Safety Data Agreement (as defined below) is in effect, advise the other of any
serious adverse events relating in any way to Zyflo or the Product and shall
provide a copy of any adverse drug experience report or other report filed with
the FDA related to such events 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 ("Safety Data 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 Zyflo or the Product and to meet
reporting requirements with any applicable Regulatory Authority.
4.3 For purposes of clarity, Abbott shall be solely responsible for
handling all customer and regulatory complaints or inquiries with respect to
Xxxxxx Products, as well as for making required reports to FDA under 21 CFR
314.80 and 314.81 regarding such Abbott Products. CTI shall reasonably cooperate
with Abbott in handling customer or regulatory complaints or inquiries related
to the Abbott Products. At the time it makes a required report to FDA, Abbott
will provide CTI a copy of such report along with any related complaint file and
documentation of any related investigation. Abbott will also inform CTI of all
product complaints with respect to Abbott Products and the outcome of any
related investigation for complaints that do not lead to reports to FDA.
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 the Product 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 Product in that country to maximize sales and revenues from such
sales until the controlled release formulation of
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Zileuton is commercially launched by CTI.
5.3 Excuse for Non-Performance. The obligations of CTI with respect to
Product under this Article 5 are expressly conditioned upon the continuing
absence of any serious adverse drug experience (as defined under 21 CFR
314.80(a)) or quality problem relating to the safety or efficacy of the
immediate release formulation of Zileuton, and the obligation of CTI to develop
or market such formulation hereunder shall be delayed or suspended so long as
such condition or event exists. An excuse for non-performance under this Section
5.3 shall only apply in the event CTI notifies Abbott of such condition or event
within fifteen (15) days if its initial occurrence and CTI takes all reasonable
and diligent actions within its ability to remove or resolve such condition or
event so that it no longer exists (including, without limitation, providing to
Abbott a plan designed to diligently remove or resolve such condition or event).
6. FINANCIAL PROVISIONS.
6.1 Trademark Assignment. In consideration of the assignment of the
Trademark to CTI hereunder, CTI shall pay to Abbott a lump sum payment of Five
Hundred Thousand United States Dollars (US$500,000) on the Effective Date.
6.2 Milestone Payment. CTI shall make a milestone payment of Seven Hundred
Fifty Thousand United States Dollars (US$750,000) to Abbott within thirty (30)
days after CTI obtains NDA approval for the Product in the United States.
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 $[**].
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6.4 Term of Royalty Payments. Royalties shall be paid on a
country-by-country basis for a period of ten (10) years from First Commercial
Sale of Product in each such country. Within thirty (30) days after the date of
First Commercial Sale of Product in each country, CTI shall notify Abbott
thereof in writing.
6.5 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 in accordance with this Agreement 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 Abbott 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 Abbott. If the review
reflects an underpayment of royalties to Abbott, such underpayment shall be
promptly remitted to Abbott. 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 Abbott, the amount of such overpayment
shall be credited against future royalties owed by CTI to Abbott.
6.10 Tax Withholding. The Parties shall use their best efforts to reduce
tax withholding on
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payments made to Abbott hereunder. Notwithstanding such efforts, if tax
withholdings under the laws of any country are required with respect to payments
to Abbott, CTI shall withhold the required amount and pay it to the appropriate
governmental authority. In such a case, CTI will promptly provide Abbott with
original receipts or other evidence sufficient to allow Abbott to document such
tax withholdings adequately for purposes of claiming foreign tax credits and
similar benefits.
7. REPRESENTATIONS AND WARRANTIES OF ABBOTT.
7.1 Abbott 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. Abbott further represents and warrants that it is duly authorized to
execute and deliver this Agreement and to perform its obligations hereunder.
7.2 Abbott shall not use or register the Trademark in any jurisdiction
anywhere in the world, and shall not use or register any trademark confusingly
similar thereto in the United States for products that are competitive to
Products. Abbott represents and warrants that it has the right to assign the
Trademark in the United States and its corresponding United States registration
and related goodwill to CTI hereunder, that it has not granted any other entity
any rights in the Trademark, that it does not know of any other entity that owns
rights in the Trademark, and that except as set forth in this Agreement, it has
no other pending applications or registrations for the Trademark, or for any
trademark confusingly similar therewith in the United States for products that
are competitive to Products. Abbott represents and warrants that it has not
assigned or granted any license to the Trademark or otherwise encumbered the
Trademark.
7.3 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.
7.4 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 Abbott
and, to the best of Xxxxxx'x knowledge, that are necessary and are used for the
manufacture, use or sale of Zyflo. Abbott has not previously assigned,
transferred, licensed, conveyed or otherwise encumbered its right, title and
interest in the Patents.
7.5 To the best of Xxxxxx'x knowledge, as of the Effective Date the
manufacture, use and sale of Zyflo in the Field in the Territory does not
infringe upon any intellectual property rights of any Third Party. As of the
Effective Date, there are no pending or, to the best of Xxxxxx'x knowledge,
threatened claims or litigation against Abbott alleging infringement relating to
the Patents, the Trademark or the manufacture, use or sale of Zyflo in the Field
in the Territory.
7.6 Abbott hereby warrants to CTI that:
(a) the Existing Products are, as of the Effective Date, (i) in compliance
with the Specifications and cGMP and (ii) warranted to be free of defects in
material and workmanship;
(b) Subject to Section 11.2 below, Abbott shall refund to CTI as its sole
remedy, CTI's
11
payment of Manufacturing Costs of any Existing Products that fail to conform
with the warranties set forth in this Section 7.6; and
(c) all Existing Products supplied to CTI hereunder conform, as of the
Effective Date, with all requirements of the Act and state and local laws, and,
for purposes of Section 303(c)(2) of the Act, the article comprising each
shipment or other delivery of Existing Products made by Abbott to CTI is hereby
guaranteed by Abbott, as of the date of such shipment or delivery, to be, on
such date, not adulterated or misbranded within the meaning of the Act, and not
an article which may not, under any section of the Act, be introduced into
interstate commerce.
8. REPRESENTATIONS AND WARRANTIES OF CTI.
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.
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. 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.
12
9.3 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
9.3, 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 any of the terms hereof in accordance with this Section 9.3, 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.
9.4 Publications. Abbott shall have the right to publish the results of
its ongoing scientific studies involving Zileuton, subject to its compliance
with this Article 9. Abbott shall submit to CTI a draft of all such publications
at least thirty (30) days prior to submission for publication and shall take
into serious consideration any requests that CTI may make in order to avoid the
unauthorized disclosure of CTI's Confidential Information and to preserve CTI's
rights to use the Patents and Know How hereunder.
10. PATENT PROSECUTION; INFRINGEMENT.
10.1 Patents. Abbott shall, during the Term, be responsible for the
filing, prosecution and maintenance of the Patents; provided, however that
Abbott shall consult with CTI prior to taking any such action and shall consider
in good faith the views of CTI regarding the advisability of the proposed
action. In the event that Abbott elects to not continue the filing, prosecution
or maintenance of any of the Patents, then Abbott shall notify CTI in writing 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 Abbott.
10.2 Notification of Claim. If a Third Party notifies CTI or Abbott, 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 Abbott shall promptly
notify the other in writing.
10.3 Third Party Infringement.
(a) Abbott 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, Abbott becomes aware of the
reasonable probability that such infringement or unauthorized use exists in the
Field in the Territory.
(b) Within ninety (90) days of becoming aware of the infringement of
the Patents in the Field Abbott 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 Abbott 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 Party or both Parties. In either such
event, each Party shall cooperate with the other Party to the extent
13
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 Abbott 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:
(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
Abbott, 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 Abbott 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 Abbott
pursuant to Section 10.3 or in an action brought against CTI or Abbott 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 prior written 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.
14
11. INDEMNIFICATION.
11.1 CTI. CTI agrees to defend Abbott and its Affiliates at its cost and
expense, and will indemnify and hold Abbott and its Affiliates and their
respective directors, officers, employees and agents (the "Abbott 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 (other than Abbott Products) by CTI, its Affiliates,
sublicensees, distributors or collaborators. In the event of any such claim
against the Abbott Indemnified Parties by any Third Party, Abbott 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 Abbott 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 or expenses incurred by the Abbott Indemnified Parties without
CTI's prior written authorization. In addition, CTI shall not be responsible for
the indemnification of any Abbott Indemnified Party arising from any negligent
or intentional acts by such Abbott Indemnified Party, or as the result of any
settlement or compromise by the Abbott 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 Abbott 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 Abbott Products by Abbott, its Affiliates, licensees,
distributors or collaborators. In the event of any such claim against the CTI
Indemnified Parties by any Third Party, CTI shall promptly notify Abbott in
writing of the claim and Abbott shall manage and control, at its sole expense,
the defense of the claim and its settlement. The CTI Indemnified Parties shall
cooperate with Abbott and may, at their option and expense, be represented in
any such action or proceeding. Abbott shall not be liable for any litigation
costs or expenses incurred by the CTI Indemnified Parties without Abbott prior
written authorization. In addition, Abbott shall not be responsible for the
indemnification of any CTI Indemnified Party arising from any negligent or
intentional acts by such CTI Indemnified Party, or as the result of any
settlement or compromise by the CTI Indemnified Parties without Abbott 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 U.S. 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).
15
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 Abbott under Section 6.4 with respect to Product in each country,
the license 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. (a) 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.
(b) In the event performance of a party under this Agreement is excused,
delayed, suspended, prevented or deemed not in default pursuant to Section 5.3
or Section 13.13, and the underlying condition, event, cause or circumstances
continue for at least six (6) months, either party shall have the right to
terminate this Agreement by providing the other party written notice thereof.
12.4 Effect of Termination. Upon termination of this Agreement pursuant to
Section 12.3, then the license granted to CTI under Section 2.1 shall
immediately terminate and CTI shall assign to Abbott all of its right, title and
interest in and to the Trademark (including all associated goodwill) and all
regulatory filings and Regulatory Approvals relating to Product.
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, 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.
If to CTI: Critical Therapeutics, Inc.
000 Xxxxxxxxxxxxx Xxxxxx
00
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
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. 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 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
17
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 Abbott, which
consent shall not be unreasonably withheld, and any assignment without such
prior written consent shall be null and void. Abbott shall notify CTI in writing
of its determination to grant or withhold such consent ("Abbott Notice") within
sixty (60) days of the date of CTI's notice to Abbott of the proposed assignment
of this Agreement. In the absence of such Abbott Notice within such sixty-day
period, consent shall be deemed to have been granted by Abbott 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 Abbott 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. Subject to Article 9, 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
18
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
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 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.]
19
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day
first above written.
XXXXXX LABORATORIES CRITICAL THERAPEUTICS, INC.
an Illinois corporation a Delaware corporation
By: /s/ Xxxxxxx X. Leiden By: /s/ Xxxxxx Xxxxxxxx
------------------------------ --------------------------------
Name: Xxxxxxx X. Leiden, MD, PhD Name: Xxxxxx Xxxxxxxx
Title: President and Chief Title: Chief Operating Officer
Operating Officer,
Pharmaceutical Products Group
20
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
21
SCHEDULE 2
Technology Transfer
Initiation
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)
Zileuton IR Product Transfer of Technology
The technology transfer of the IR 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 one-day meeting will be scheduled between
CTI and the appointed TPM, SKP, and Abbott technical staff at a date agreed
upon by the Parties
[**]
Regulatory Documents Consistent with the requirements of 21 CFR 314.72
o Complete copy of the approved NDA 20-471
o All post approval submissions (supplements, PSUR's, advertising
and promotional submissions to DDMAC)
o Annual reports and all records required to be kept under 21CFR
314.81 (field alert reports, recalls, etc)
o Copy of the complete IND file for Zyflo
o Copy of all Regulatory correspondence file for the IND and NDA
TRANSFER SAFETY DATABASE INCLUDING CLINICAL AND POST MARKETING AES PER
"SAFETY DATA AGREEMENT"
TRANSFER DATABASE AND STATISTICAL ANALYSES FOR PHASE III CLINICAL TRIALS
ZILEUTON IR PRODUCT IN ASTHMA
- M91-685: Phase III pivotal Study
- M92-720: Phase III Pivotal Study
CLINICAL REPORTS, DATABASE AND STATISTICAL ANALYSES OF OTHER ASTHMA STUDIES
ONGOING AT THE TIME OF NDA SUBMISSION
- M94-199
- M92-735
- M92-752
- M92-868
- M92-778
- M92-872
- M92-763
- M90-544
- M92-738
- M92-779
- M92-798
- M92-858
CONTRACTS (OR DESCRIPTION OF ANY COMMITMENTS MADE TO INVESTIGATORS
CONDUCTING TRIALS WITH ZYFLO)
OFFICIAL LABELING FILES
22
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.
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(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 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.
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(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-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
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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.
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
Trademark Assignment
WHEREAS, Xxxxxx Laboratories, an Illinois corporation (the "Assignor"),
has adopted and used certain trademarks, trade names, logos and service marks,
as set forth on Exhibit 1 attached hereto (the "Trademarks"); and
WHEREAS, pursuant to the License Agreement dated as of ___________, 2004
(the "License Agreement") between the Assignor and Critical Therapeutics, Inc.,
a Delaware corporation ("Assignee"), Assignee has agreed to acquire the
Trademarks and any and all registrations thereof from Assignor; and
WHEREAS, the execution of this Trademark Assignment by Assignor is one of
the obligations of Assignor pursuant to the License Agreement;
NOW, THEREFORE, for good and valuable consideration, receipt of which is
hereby acknowledged:
Assignor does hereby assign, sell and transfer unto the Assignee, free and
clear of all liens and other encumbrances, all right, title and interest in and
to the Trademarks, together with (a) any and all registrations of and
applications to register the Trademarks, to the extent such Trademarks exist,
(b) the goodwill of the business symbolized by and associated with the
Trademarks and any registrations thereof, and (c) the right to xxx and recover
for, and the right to profits or damages due or accrued arising out of or in
connection with, any and all past, present and future infringements or dilution
of or damage or injury to the Trademarks or any registrations thereof or such
associated goodwill.
IN WITNESS WHEREOF, the Assignor, by its duly authorized officer, has
executed this assignment, as an instrument under seal, on this ___ day of
________, 2004.
XXXXXX LABORATORIES
By:
---------------------------
Name:
Title:
STATE OF )
) ss.
COUNTY OF )
On this the ___ day of ________, 2004, before me appeared ______________,
the person who signed this instrument, who acknowledged that (s)he is the
__________ of Xxxxxx Laboratories and that being duly authorized (s)he signed
such instrument as a free act on behalf of Xxxxxx Laboratories.
-------------------------------
Notary Public
My commission expires:
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Exhibit 1
Xxxx Type Registration/Serial No.
---- ---- -----------------------
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