Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Exhibit 10.13
DECEMBER 3, 2003
AGREEMENT
BETWEEN
CRITICAL THERAPEUTICS, INC
AND
JAGOTEC AG
TABLE OF CONTENTS
1. DEFINITIONS...................................................... 1
2. OTHER AGREEMENTS................................................. 8
3. PRODUCT PLAN..................................................... 9
4. CONDITION PRECEDENT.............................................. 9
5. CONSIDERATION.................................................... 9
6. REGULATORY MATTERS............................................... 12
7. TECHNOLOGY TRANSFER AND LICENCE.................................. 13
8. MANUFACTURE...................................................... 13
9. QUALITY CONTROL TESTING.......................................... 14
10. RECORDS AND INSPECTIONS.......................................... 15
11. MANUFACTURE OF COMMERCIAL SUPPLIES............................... 15
12. TERM AND TERMINATION............................................. 16
13. FORCE MAJEURE.................................................... 17
14. CONFIDENTIALITY.................................................. 17
15. INDEMNIFICATION.................................................. 19
16. NOTICES.......................................................... 20
17. FURTHER ASSURANCES............................................... 21
18. ASSIGNMENT....................................................... 21
19. THIRD PARTY RIGHTS............................................... 21
20. ENTIRE AGREEMENT................................................. 22
21. GENERAL.......................................................... 22
22. ARBITRATION...................................................... 23
23. GOVERNING LAW.................................................... 24
AGREEMENT dated December 3, 2003
PARTIES:
(1) CRITICAL THERAPEUTICS, INC a company duly-incorporated and existing
under the laws of the State of Delaware whose principal place of
business is at 000 Xxxxxxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, XXX
("CTI"); and
(2) JAGOTEC AG, a company duly incorporated and existing under the laws of
Switzerland whose principal place of business is at Xxxxxxxxxxxxxxx 00,
Xx-0000, Xxxxxxx, Xxxxxxxxxxx ("SkyePharma").
INTRODUCTION:
(A) By an agreement dated 3 October 1996 (the "Abbott Licence") SkyePharma
granted Abbott an exclusive, worldwide right and licence under certain
patents and know-how to make, have made, import, use, offer for sale,
market, distribute and sell Products (as defined below) with the right,
subject to SkyePharma's consent, to sub-licence such rights.
(B) Abbott intends to grant CTI a licence (the "CTI Licence") to develop
and commercialise the Product under intellectual property owned by or
licensed to Abbott including intellectual property licensed to Abbott
under the Abbott Licence.
(C) SkyePharma has agreed to consent to the sub-licence to CTI pursuant to
the CTI Licence and to provide certain services to CTI in connection
with obtaining registrations for products and the manufacture of
clinical supplies and samples of Product on the terms of this
Agreement.
IT IS AGREED as follows:
1. DEFINITIONS
In this Agreement, unless the context otherwise requires:
"Abbott" means Xxxxxx Laboratories of 000 Xxxxxx Xxxx
Xxxx, Xxxxxx Xxxx, Xxxxxxxx, 00000-0000, XXX.
"Abbott Licence" has the meaning ascribed to it in the
Introduction.
"Abbott Technology" means the Product Know-how in the possession
of or controlled by Abbott or any of its
Affiliates as at the Effective Date and
relating to or of use in the manufacture of
Products or that is subsequently made
available to CTI pursuant to the CTI
Agreement.
1
"Act" means the US Federal Food, Drug and Cosmetic
Act of 1938, the Public Health Service Act of
1944 and the regulations promulgated under
that Act, as may be amended from time to
time.
"Affiliate" means any entity in which the party has a
direct or indirect equity or income interest
ownership of at least fifty percent (50%) or
more, or any entity which, directly or
indirectly, through one or more
intermediaries, controls, is controlled by or
is under common control with that party. For
the purpose of this definition, "control"
means the possession, directly or indirectly,
of the power to direct the management or
policies of an entity, whether through the
ownership of voting securities, by contract
relating to voting rights or corporate
governance, or otherwise and the terms
"controlled by" and "under common control
with" have corresponding meanings.
"Agency" means any applicable supra-national, federal,
national, regional, state, provincial or
local regulatory agencies, departments,
bureaus, commissions, councils or other
government entities regulating or otherwise
exercising authority with respect to the
manufacture or distribution, use or sale of
the Product, including the FDA.
"API" Means the active pharmaceutical ingredient
zileuton (ABT-077) to be used in the
manufacture of Product.
"Applicable Laws" means the Act and other applicable laws,
rules, regulations, including any rules,
regulations, guidelines or other requirements
of any Agency, that may be in effect from
time to time in the US or such other
countries as may be agreed pursuant to Clause
3.2.
"Batch" means 1,200,000 tablets of the Product that
is intended to be of uniform character and
quality, within specified limits, and is
produced during a single cycle of manufacture
and is designated by a unique batch number.
"Batch Records" means the set of detailed manufacturing
process instructions and data prepared to
establish that a particular Batch has been
manufactured according to cGMP.
"Business Day" means a day not being a Saturday or Sunday on
which banks are generally open for business
in the US and/or Switzerland.
2
"cGMP" means the Current Good Manufacturing
Practices as defined from time to time under
the Act and other Applicable Laws including
the Current Good Manufacturing Practices set
forth in 21 C.F.R. 210 and 21 C.F.R. 211 and
relevant FDA guidance documents; and to the
extent applicable European Community
Directive 91/356/EEC, Directive 2001/20/EC,
Directive 2001/83/EC and all relevant
implementations of such directives and
relevant guidelines including the EC
Guidelines.
"Clinical Supplies" has the meaning ascribed to it in Clause 8.1.
"CMC Data" means the chemistry, manufacturing and
controls data or, as the case may be, the
product specifications, manufacturing
formulae and processing instructions required
by Applicable Laws, including, (i) in the
case of an application for approval to
conduct clinical research under an IND, 21
C.F.R. Section 312.23(a)(7), and, to the
extent that it is applicable, European
Community Directive 2001/20/EC; or (ii) in
relation to a NDA, 21 C.F.R.Section
314.50(d)(1) or, to the extent that they are
applicable, the Quality Overall Summary
section 2.3 of Module 2 and Module 3 of the
Common Technical Document developed and
agreed by the International Conference on
Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
(ICH) or Part I, Module 3 of Annex 1 to
Directive 2001/83/EC and the EC Guidelines.
"Confidential in relation to a party, any and all technical
Information" and commercial materials and information and
know-how, which is proprietary or
confidential in nature including, without
limitation, know how, trade secrets,
specifications, products, processes,
services, contracts, business methods or
practices, pricing techniques and
information, financial information,
intellectual property and ideas which, at the
time or times concerned, are not generally
known to third persons and is identified by
that party as confidential.
"COPD" means chronic obstructive pulmonary disease.
"CTI Licence" has the meaning ascribed to it in the
Introduction.
3
"Drug Master File" means a drug master file providing detailed
information about the facility, the equipment
and manufacturing processes relating to the
API and such other information as required by
Applicable Laws, including 21 C.F.R. Section
314.420 and to the extent applicable any
equivalent requirement in under Applicable
Laws including as required by the Committee
for Proprietary Medicinal Products Note for
Guidance on the European Drug Mater File
Procedure for Active Ingredients.
"EC Guidelines" means Volume 4 of the Rules Governing
Medicinal Products in the European Union:
Medicinal Products for Human and Veterinary
Use: Good Manufacturing Practices.
"Effective Date" means the date on which the conditions set
out in Clause 4.1 are satisfied.
"Equipment" means any equipment or machinery used by
SkyePharma in the manufacturing of Product or
the holding or quality control testing of any
Product, bulk API, excipients or packaging
components.
"Facility" means the SkyePharma facility located in
Xxxxx, France at which the Non-Commercial
Supplies are manufactured.
"FDA" means the United States Food and Drug
Administration and any successor agency.
"Force Majeure" means in relation to either party any
circumstances beyond the reasonable
control of that party including any strike,
lock-out, or other form of industrial action,
act of God, war, act of terrorism, riot,
accident, fire, flood, explosion or
government action.
"Fully Allocated" means the fully-burdened cost of
manufacturing Products, including the cost of
(i) raw materials, (ii) direct labor of
SkyePharma employees or its Affiliate's
employees (including basic wages, labor and
related payroll taxes and benefits) incurred
or spent in the actual production, labeling
and packaging of Product, including without
limitation for quality assurance and
manufacturing facility operations, and (iii)
overhead of SkyePharma and its Affiliates
(including operating expenses, indirect labor
and related payroll taxes and benefits,
depreciation, applicable taxes, insurance,
repairs and maintenance, supplies) incurred
or spent in support of the actual production,
packaging and labeling of Product, but not
for cost of any unused manufacturing
4
capacities that SkyePharma may have in excess
of the requirements contained in the
forecasts provided by CTI, and, in the case
of (ii) and (iii) above, excluding taxable
benefits, remuneration based on profitability
or bonuses, and (iv) transportation, storage,
non-reimbursable import or export taxes of or
for Product as incurred or spent by
SkyePharma or its Affiliates in connection
with the supply of Product pursuant to the
terms of this Agreement and the Manufacturing
Agreement (as defined in Section 11.1), all
as determined in accordance with generally
accepted accounting principles consistently
applied.
"Geomatrix System" means SkyePharma's novel pharmaceutical
technology for the controlled release of
active substances, and related technology
which utilises a hydrophilic drug-containing
matrix tablet to control the release of an
active substance through the use of one or
more barrier layers, as disclosed in Product
Know-how and claimed in the SkyePharma
Patents.
"IND" means an investigational new drug application
filed with the FDA for authorisation to
commence human clinical trials.
"Marketing Approval" means the approvals issued by any Agency in
accordance with any procedures as may be
required by Applicable Law to market the
Product in the relevant country.
"NDA" means an application for approval to market a
drug as required under the Act and the
regulations promulgated under the Act or any
equivalent application as required by
Applicable Laws.
"NDA Supplies" Has the meaning ascribed to it in Clause 8.1.
"Net Sales" means the gross invoiced amounts from the
transfer for value (cash or otherwise) of
Products in any country by or on behalf of
CTI, its Affiliates and, solely in relation
to Section 5.5(b), its sub-licensees, to an
independent third party (including, without
limitation, distributors) after obtaining all
necessary government approvals to such sale,
less where factually applicable and in
accordance with general and customary trade
practices:
(a) importation, handling, special
outbound packing, transportation
and insurance charges, separately
billed to the customer or pre-paid;
5
(b) sales, use, excise, turnover,
inventory, value added and similar
taxes and/or duties specifically
imposed upon the production,
importation, use or sales of
Product actually incurred by CTI,
but not including income tax;
(c) offered and taken trade, quantity
and cash discounts, rebates,
commissions, charge-backs granted
to drug wholesalers, management
fees to group purchasing
organisations, price reductions,
retroactive or otherwise, imposed
by governments or government
agencies, and distribution fees in
amounts customary to the trade and
as required to do business in that
country; and
(d) allowances, adjustments, direct and
indirect credits and refunds,
including price adjustments,
granted to customers on account of
rejections or returns of defective,
damaged, recalled or outdated
Product or on account of
retroactive price reductions
affecting the pricing of such
Products.
"Non-Commercial
Supplies" means Clinical Supplies and NDA Supplies.
"Product" means the dosage forms of a finished product
containing ABT-077 as the sole therapeutic or
prophylactic active ingredient, in a matrix
tablet using the Geomatrix System.
"Product Know-how" means all non-patented information and
technical data which is not generally known,
including patent application information not
yet in the public domain, formulae,
formulations, procedures, protocols,
processes, techniques, and results of
experimentation, development and testing,
which is or can reasonably be viewed as
necessary or useful in the development,
formulation, manufacture, use, marketing,
sale or application for regulatory approval
in order to market and distribute Products.
"Product Plan" means the Zileuton Revised Plan and Timeline
set out in Schedule 1.
"Quality Agreement" means a written agreement describing the
obligations of the parties with regards to
compliance, quality systems, and testing and
Release of Product as may be required by
Applicable Laws.
6
"Quarter" each three calendar-month period ending on
31st March, 30th June, 30th September and
31st December in each year.
"Registrations" means any and all technical, medical and
scientific licences, registrations,
authorisations and/or approvals of the
Product (including clinical research
authorization, manufacturing approvals and
authorisations, Marketing Approvals,
manufacturing facility approvals or
authorizations, and pricing, third party
reimbursement and labelling approvals) that
are required by any Agency for the
manufacture, distribution, use or sale of the
Product in any country, as amended or
supplemented from time to time.
"Release" means quality assurance review of all
Manufacturing documentation related to a
Batch, and confirmation that a particular
Batch has been manufactured according to the
Batch Records and cGMP, and meets all
Specifications.
"SkyePharma Patents" means, to the extent that they contain a
Valid Claim covering the Geomatrix System or
the use of the Geomatrix System with
Products:
(a) the patents and applications
specified in Schedule 2
(b) any other patents or patent
applications filed and/or otherwise
pending during the term of this
Agreement and owned by or licensed
to SkyePharma; and
(c) any and all re-issues,
reexaminations, substitutions,
confirmations, renewals,
extensions, continuations,
continuations-in-part or divisions
of such patents or patent
applications.
"Specifications" means the performance parameters to which the
Non-Commercial Supplies, ingredients and
packaging components must comply to be
considered acceptable including all written
instructions, specifications, formulae
procedures, tests and standards for the
Product, including the requirements of all
Registrations, as adopted pursuant to Clause
8.2 or as amended or supplemented from time
to time in accordance with Clause 8.6.
"Stability Tests" means those tests necessary to establish the
storage conditions and expiry date of the
Product required by 21 C.F.R. 211.137 and 21
C.F.R. 211.166 or any other Applicable Laws
including Part I, Module 3 of Annex 1 to
Directive 2001/83/EC.
7
"US" means the United States of America.
"Valid Claim" means a claim to the Geomatrix System, or the
use of that system with Products, of any
issued, unexpired patent which is contained
within the SkyePharma Patents and which has
not been held invalid, unpatentable or
unenforceable by a final decision, which
decision is unappealed or unappealable, of a
court of competent jurisdiction or of an
administrative agency having authority over
patents in that jurisdiction.
"Year" means a calendar year running from 1 January
to 31 December.
1.2 Unless otherwise expressly stated, reference to the Introduction, a
Clause, Schedule or Exhibit is to the Introduction to, a Clause of, or
a Schedule or Exhibit to, this Agreement and references in any Schedule
to a Paragraph is to a paragraph in that Schedule.
1.3 The Introduction, Exhibits and Schedules form part of this Agreement
and will have the same force and effect as if expressly set out in the
body of this Agreement and any reference to this Agreement will include
the Introduction, Exhibits and the Schedules.
1.4 The Index and Clause headings are for convenience only and will not
affect the interpretation of this Agreement.
1.5 In this Agreement, any phrase introduced by the terms "include" or any
similar expression and will be construed as illustrative and will not
limit the sense of the words proceeding them.
1.6 In this Agreement, unless the context otherwise requires:
(a) use of the singular is deemed to include the plural and vice
versa;
(b) use of any gender is deemed to include every gender; and
(c) reference to a person includes a natural person, a firm, a
corporation, a partnership, a trust, an association, an
organisation and any other body or entity whether or not
having separate legal personality.
1.7 Any undertaking by any of the parties not to do any act or thing shall
be deemed to include an undertaking not to permit or suffer or assist
the doing of that act or thing.
2. OTHER AGREEMENTS
2.1 This Agreement supersedes the binding heads of terms between the
parties dated September 30, 2003 which on execution of this Agreement
will be of no further force or effect.
8
2.2 This Agreement is without prejudice to the Abbott Licence or the CTI
License, each of which remains in full force and effect. For the
avoidance of doubt no provision of this Agreement shall effect:
(a) the obligations of either Abbott or SkyePharma under the
Abbott Licence; or
(b) the obligations of CTI to make payments to Abbott in
accordance with the CTI Licence.
3. PRODUCT PLAN
3.1 The timelines and procedures for obtaining Registrations for the
Product in the US and transferring the Abbott Technology are set out in
the Product Plan. Each of the parties will use its reasonable
endeavours to adhere to the Product Plan and will co-operate with the
other party in the implementation of the Product Plan.
3.2 The Product Plan may only be amended with the written consent of both
parties. Notwithstanding anything to the contrary in the foregoing, if
the Product Plan is amended by CTI to include a country outside the US,
or CTI otherwise gives SkyePharma not less than 3 months written notice
that it will be applying for Registrations in a country outside the US,
references in this Agreement to Applicable Laws will upon elapse of
said three month time period include the Applicable Laws in that
country. In the absence of agreement by SkyePharma to the contrary,
SkyePharma shall not be obliged to provide any assistance or incur any
expense including, without limitation, support any development, assist
in any regulatory approval or manufacture in respect of Product to be
sold outside the US.
4. CONDITION PRECEDENT
4.1 This Agreement will not come into effect until CTI and Xxxxxx have
executed the CTI Licence.
4.2 If the conditions set out in clause 4.1 have not been satisfied by 30
November 2003 or such later date as SkyePharma may agree in writing
this Agreement shall terminate without further liability to either
party.
4.3 Subject to this Agreement becoming effective in accordance with Clause
4.1, SkyePharma hereby consents for the purposes of Clause 2.1 of the
Xxxxxx Licence, to the grant to CTI by Xxxxxx of an exclusive,
worldwide sub-licence under the SkyePharma Patents and Product Know-how
to manufacture, make, have made, import, use, offer for sale, market,
distribute, have sold and sell Products in accordance with the CTI
Licence.
5. CONSIDERATION
5.1 CTI will make the following payments to SkyePharma:
9
(a) in consideration of the work done to date on the Product, a
non-refundable and non-reimbursable fee of seven hundred and
fifty thousand dollars (US$ 750,000) to be paid on the
Effective Date;
(b) the sum of [**] dollars (US$ [**]) upon replication of the
Product release profile and establishing the Specifications as
set forth in the Product Plan;
(c) the sum of [**] dollars (US$ [**]) upon commencement of the
manufacture of the NDA Supplies at the Facility;
(d) [**] dollars (US$ [**]) within thirty (30) days following FDA
approval of the Product for COPD;
(e) an amount equal to [**] per cent ([**]%) of (i) the license
fee paid by CTI to Xxxxxx under the CTI Licence and (ii) any
milestone payments made by CTI to Xxxxxx on or after the
submission of an NDA (including, for the avoidance of doubt,
the milestone payment related to the achievement of such NDA
submission) pursuant to the CTI Licence, within thirty (30)
days following the date upon which such payment is due to
Xxxxxx, provided that no part of such amounts shall fall due
for payment to SkyePharma, regardless if such payment is due
to Xxxxxx, until the sum payable pursuant to Clause 5.1(b) has
fallen due for payment in accordance with that Clause. For
purposes of clarity no amount shall be due from CTI to
SkyePharma based upon royalty payments made by CTI to Xxxxxx.
(f) a royalty on Net Sales at the rate of [**] per cent ([**]%) up
to [**] dollars (US$ [**]) in Net Sales in any Year. For the
avoidance of doubt no royalties shall be payable by CTI to
SkyePharma on Net Sales in excess of [**] dollars (US$ [**])
in any Year.
5.2 For the avoidance of doubt payments to SkyePharma pursuant to this
Clause 5 shall be without prejudice to
(a) any payment due to SkyePharma pursuant to the Xxxxxx Licence;
(b) any payment due to Xxxxxx pursuant to the CTI Licence.
5.3 CTI will pay royalties on Net Sales in accordance with Clause 5.1(f) on
a country by country basis in countries in which a Valid Claim exists
from the date of first sale of any Product in a particular country
until the expiry or lapse of all SkyePharma Patents in such country.
5.4 In calculating Net Sales, sales will be accounted for when shipped, and
credits and refunds will be accounted for when booked. Sales or
transfers between or among CTI and its Affiliates and sub-licensees
will be excluded from the computation of Net Sales, except where such
Affiliates or sub-licensees are end users; but Net Sales will subject
to Clause 5.6 include the subsequent final sales to third parties by
such Affiliates and sub-licensees.
10
5.5 If CTI sub-licenses any rights granted to it under the CTI Licence to
any third party, CTI will pay to SkyePharma the amount that is equal to
the greater of:
(a) the sum equal to [**] per cent ([**]%) of all net receipts
(including royalties payable to CTI in relation to
sub-licensees' sales of the Products and any other fees or
payments but excluding amounts received by CTI if and to the
extent such amounts fund research conducted by CTI) received
from any sub-licensee (excluding distributors); or
(b) a sum equal to [**] per cent ([**]%) of Net Sales by or on
behalf of any sub-licensee.
5.6 For so long as any royalties are payable under this Agreement, CTI will
prepare a statement prepared in accordance with generally accepted
accounting principles consistently applied showing the aggregate Net
Sales by country in each Quarter. CTI will submit such statement to
SkyePharma within 60 days of the end of the relevant Quarter together
with remittance for the royalties due to SkyePharma in respect of that
Quarter.
5.7 CTI will pay for all activities performed by SkyePharma pursuant to
Clauses 6 to 10 (inclusive) on the basis of the actual time spent by
SkyePharma at an hourly rate of US$ [**] plus all reasonable
out-of-pocket expenses incurred by SkyePharma. At the end of each
month, SkyePharma will submit an invoice to CTI detailing the time
spent and expenses incurred in conducting its activities pursuant to
Clauses 6 to 10 in the preceding month and CTI shall pay the amount due
within 30 days of receipt of such invoice.
5.8 CTI shall during the term of this Agreement keep true and accurate
records of all Net Sales and books of account containing all the data
necessary for the calculation of royalties under this Clause 5. Such
records and books of account shall, on reasonable notice having been
given by SkyePharma, be open during normal working hours on any
business day for inspection by SkyePharma or its duly authorised
representative. If any such inspection reveals an underpayment of
royalties due to SkyePharma in excess of 5%, the cost of such
inspection shall be borne by CTI and promptly paid upon receipt of an
invoice in respect of the same. If any such inspection reveals an
overpayment of royalties due to SkyePharma, then such amount shall be
deducted from royalty payments due in the next Quarter.
5.9 If any royalty or other amount due to SkyePharma is overdue then CTI
shall pay interest thereon at an annual rate (but with interest
accruing on a daily basis) at 2 per cent above the base rate of
interest reported in The Wall Street Journal, Eastern Edition, for the
date such amount was due, such interest to run from the date upon which
payment of such sum became due until payment thereof in full together
with such interest by CTI.
5.10 All sums due to SkyePharma under this Agreement:
(a) are, unless otherwise expressly stated, exclusive of any Value
Added Tax or equivalent sales tax which shall be payable (if
applicable) on submission by SkyePharma of valid Value Added
Tax invoices in respect thereof; and
11
(b) will be paid in full without any set-off, deduction or
withholding except any tax which CTI is required by law to
deduct or withhold, and if CTI is required by law to make any
such tax deduction or withholding, CTI shall do all in its
power which may be necessary to enable or assist SkyePharma to
claim exemption from or (if that is not possible) a credit for
the deduction or withholding under any applicable double
taxation or similar agreement from time to time in force, and
shall from time to time give SkyePharma proper evidence as to
the deduction or withholding any payment over the tax deducted
or withheld.
5.11 All royalties and other sums payable under this Agreement shall be paid
in US dollars (US$). Where any royalties or other sums falling due in
any period covered by the written statements referred to in Clause 5.7
are calculated in a currency other than US$, they shall be converted
into US$ by reference to the exchange rate published in the Midwest
edition of the Wall Street Journal as of the close of business on the
last Business Day of the applicable royalty period, or if no such rate
is published the exchange rates for the applicable Quarter set out in
International Statistics published by the International Monetary Fund
on the last Business Day of the applicable royalty period.
6. REGULATORY MATTERS
6.1 CTI represents and undertakes to SkyePharma that it will comply with
the terms of the CTI Licence.
6.2 Without prejudice to Clause 6.1, CTI will use reasonable efforts
(consistent with those that would be applied by other pharmaceutical
companies) at its own expense, to develop and commercialise the
Products. In particular, CTI will use reasonable efforts to:
(a) prepare, or obtain a right of reference to, a Drug Master File
for the API and will where required by Applicable Laws, file,
or arrange for the filing of, the Drug Master File with
appropriate Agencies;
(b) prepare and submit INDs and NDAs for the Product to the FDA,
(c) subject to clause 3.2, prepare and submit such other
Registrations as may be required by Applicable Laws (except
any Registration relating solely to the manufacture of the
Product by SkyePharma);
(d) provide to SkyePharma such information and assistance and
enter into such agreements as may be required by Applicable
Laws (including any Quality Agreements) as SkyePharma may
reasonably require for the purposes of applying for and
maintaining any Registration for the manufacture of the
Product, including providing SkyePharma with all reports,
authorisations, certificates, methodologies, and other
documentation in the possession or under the control of CTI
relating to the manufacture of the Product (or any component
thereof);
6.3 SkyePharma will assist CTI in gaining a US IND and an US Marketing
Approval for the Product for use in the treatment/prevention of asthma
and COPD and in particular will:
12
(a) assist CTI in the preparation of the CMC sections of the IND
and NDA submission;
(b) provide to CTI such information and assistance and enter into
such agreements as may be required by Applicable Laws
(including Quality Agreements), as CTI may reasonably require
for purposes of applying for and maintaining all Registrations
for the Product, including providing CTI with all reports,
authorisations, certificates, methodologies, and other
documentation in the possession or under the control of
SkyePharma relating to the manufacture of the Product (or any
component thereof);
(c) at CTI's request, attend meetings with the FDA in relation to
the Product or the Geomatrix System;
(d) provide such other services and assistance as CTI may
reasonably request and which SkyePharma agrees to undertake.
7. TECHNOLOGY TRANSFER AND LICENCE
7.1 CTI will procure that SkyePharma has access to the Xxxxxx Technology
pursuant to the terms of the CTI Licence. Subject to CTI securing such
access, SkyePharma will be responsible for transferring the Xxxxxx
Technology to the Facility.
7.2 Subject to Clause 2.2 and the other terms and conditions of this
Agreement, CTI hereby grants to SkyePharma a non-exclusive,
non-transferable, royalty free licence, under the intellectual property
licensed to CTI under the CTI License to manufacture Product in
accordance with Clause 8.
8. MANUFACTURE
8.1 SkyePharma will manufacture such quantities of the Product as CTI may
reasonably require in connection with clinical studies (the "Clinical
Supplies") and obtaining regulatory approval to market the Product in
the US and such other countries as may be agreed pursuant to Clause 3.2
("NDA Supplies"). CTI will give SkyePharma not less than four (4)
months prior written notice of its requirements for Clinical Supplies
and NDA Supplies and SkyePharma shall supply the Clinical Supplies and
the NDA Supplies as required by CTI by the delivery date(s) specified
in CTI's written notice of its requirements.
8.2 Not less than three (3) months prior to the commencement of the
manufacture of the Non-Commercial Supplies, the parties shall agree on
the Specification.
8.3 CTI will, at its own cost, provide SkyePharma such quantities of API
(allowing for a production loss) as may be required to manufacture the
Non-Commercial Supplies. CTI shall ensure that the API supplied to
SkyePharma complies with cGMP and all Applicable Laws and is of a
quality that allows SkyePharma to comply with its obligations under
Clause 8.4 and shall deliver the required quantities of API to
SkyePharma not less than four months prior to the anticipated date of
delivery of the
13
relevant batch of Non-Commercial Supplies. For the avoidance of doubt
SkyePharma shall be under no obligation to manufacture Non-Commercial
Supplies if CTI fails to deliver API in accordance with this Clause
8.3.
8.4 SkyePharma will manufacture the Non-Commercial Supplies in compliance
with:
(a) the Specifications;
(b) any applicable Registrations and Quality Agreement; and
(c) cGMP and all other Applicable Laws.
8.5 SkyePharma will obtain and maintain any regulatory approvals required
by Applicable Laws to manufacture the Non-Commercial Supplies at the
Facility and will ensure that the Facility and practices that shall be
used in the performance of the manufacturing contemplated hereunder
shall conform to the requirements of Applicable Laws, Batch Records and
Specifications.
8.6 SkyePharma may not change the Specifications in any respect without the
prior written consent of CTI. CTI may amend the Specifications and the
CMC Data on giving SkyePharma not less than thirty (30) days notice of
the proposed change if:
(a) the amendment is reasonably required for the purpose of
complying with Applicable Laws in which event CTI shall pay to
SkyePharma all reasonable direct costs and disbursements as
set out under clause 5.7.
(b) SkyePharma has given its prior written consent to the
amendment.
8.7 SkyePharma will deliver the Non-Commercial Supplies in bulk, EX
(Incoterms 2000) the Facility.
9. QUALITY CONTROL TESTING
9.1 SkyePharma will implement and maintain appropriate processing and
control procedures, including the assignment of unique identification
numbers to each Batch of Clinical Supplies and NDA Supplies and the
maintenance of production records, quality control records, Batch
Records and related information.
9.2 SkyePharma will take and retain, for such period as may be required by
Applicable Law, samples of Clinical Supplies sufficient to perform at
least full duplicate quality control testing, and will submit to CTI,
upon CTI's written request, such samples and manufacturing and quality
control records as CTI may reasonably request in order to implement
analytical or other controls required by Applicable Law.
9.3 SkyePharma will perform Stability Tests for the Product in accordance
with cGMP, the Registrations, Applicable Laws and ICH Guidelines for
stability testing.
14
9.4 SkyePharma shall perform Release tests on Clinical Supplies and NDA
Supplies in accordance with Applicable Laws and the terms of this
Agreement and the Quality Agreement. SkyePharma shall provide to CTI a
Certificate of Analysis with respect to the results for final drug
release testing, as further specified in the Quality Agreement.
9.5 SkyePharma represents and warrants that it has engaged all staff
necessary to comply with cGMP (whether as employees or as a third party
contractor) including, those personnel required by 21 C.F.R. 211 and
where applicable the Qualified Person as required by European
Commission Directives 2001/83/EC and 91/356/EEC and all other
Applicable Laws.
10. RECORDS AND INSPECTIONS
10.1 All records, including originals thereof, relating to manufacturing of
the Clinical Supplies and NDA Supplies shall be retained by SkyePharma
for a period of at least five (5) years from the date of expiration of
each Batch of Product to which such records pertain, or such longer
period as may be required by Applicable Laws. SkyePharma will provide
CTI with copies of such records, upon the written request of CTI.
10.2 CTI and its agents may, upon reasonable prior notice to SkyePharma,
inspect the Facility, the Equipment and the Manufacturing of the
Non-Commercial Supplies during normal business hours in order to
ascertain compliance by SkyePharma with the terms of this Agreement.
10.3 If SkyePharma receives notice of any visit or inspection by any Agency
of that part of the Facility engaged in the manufacture of Product,
SkyePharma will promptly notify CTI of such visit or inspection and it
will permit CTI or its agents to be present and participate in such
visit or inspection. SkyePharma shall provide to CTI a copy of any
report and other written communications received from such Agency in
connection with such visit or inspection, and any written
communications received from any Agency, or sent to any Agency by
SkyePharma, relating to the Product or the production of Product, as
soon as practicable and in any event within 3 Business Days after
receipt and will to the extent practicable consult with CTI concerning
the response to each such communication.
10.4 Each party will report to the other on a monthly basis any complaints
received by the other relating to any Clinical Supplies, NDA Supplies,
bulk active, or the excipients or packaging components used in the
manufacture of the Product, including any product quality complaint.
Each will notify the other within one (1) Business Day after its
receipt of any notice of any event that may necessitate a field alert
under Applicable Law.
10.5 CTI and SkyePharma will each maintain complaint files regarding the
Clinical Supplies, including any product quality complaints. SkyePharma
will cooperate with CTI to investigate and resolve such complaints and
to take remedial action to avoid similar complaints in the future.
11. MANUFACTURE OF COMMERCIAL SUPPLIES
15
11.1 Upon FDA approval of the Product, SkyePharma will manufacture
commercial supplies of the Product in accordance with the Manufacturing
Agreement ("Manufacturing Agreement"), the terms of which shall be
negotiated in good faith by the Parties subject to Section 11.2 below.
If there is any conflict between the terms of this Agreement and the
terms of the Manufacturing Agreement, the terms of the Manufacturing
Agreement shall prevail.
11.2 Notwithstanding anything in this Agreement to the contrary, the
Manufacturing Agreement will contain, at a minimum, the following
terms:
(a) The Manufacturing Agreement shall commence on or before the
date on which the Product is approved by the FDA for asthma;
(b) The Product will be supplied to CTI at Fully Allocated costs
plus [**]%;
(c) The Manufacturing Agreement will include [**]; and
(d) The term of the Manufacturing Agreement shall be for a minimum
period of 5 years.
12. TERM AND TERMINATION
12.1 This Agreement will commence on the Effective Date and will continue
unless the Agreement is terminated pursuant to Section 12.2; provided,
however, that CTI's obligations under Clause 5 hereunder (other than
those under Sections 5.1(a)-(d) and 5.7, except to the extent that the
obligations have accrued due prior to such termination) shall survive
any such termination of this Agreement.
12.2 This Agreement may be terminated forthwith at any time by either party
("the Terminating Party") on written notice served on the other party
("the Defaulting Party") if:
(a) the Defaulting Party is in breach of any of its obligations
hereunder and, in the case of a breach capable of remedy, it
shall not have been remedied by the Defaulting Party within 30
(thirty) days of written notice served by the Terminating
Party specifying the breach and requiring its remedy; or
(b) an encumbrancer takes possession or a receiver is appointed
over the whole or any part of the assets of the Defaulting
Party; or
(c) the Defaulting Party makes any voluntary arrangement with its
creditors, or has a petition for an administration order
presented against it; or
(d) the Defaulting Party goes into liquidation (otherwise than in
furtherance of a scheme for amalgamation or reconstruction);
or
(e) anything analogous to any of sub-clauses (b) to (d) under the
law of any relevant jurisdiction occurs in relation to the
Defaulting Party; or
16
(f) the Defaulting Party ceases, or threatens to cease to carry on
business.
12.3 In the event of termination of this Agreement SkyePharma shall cease
manufacture of Product and shall, if requested by CTI and at CTI's
expense, return any API held by SkyePharma to CTI or as it may direct.
12.4 In the event of termination of this Agreement each party shall, at the
option of the other either:
(a) return the other party's Confidential Information and any
copies and extracts relating to it to the other party, or
(b) destroy or delete that Confidential Information and any copies
and extracts and certify to the other party in writing that it
has done the same.
12.5 Expiration or termination of this Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or
termination. The rights and obligations of the parties under Clauses 5
(including, without limitation, CTI's royalty obligations), 10.1, 10.4,
10.5, 12.4, this 12.5, 14, 15, 16, 21, 22 and 23 shall survive
expiration or termination of this Agreement.
13. FORCE MAJEURE
In the event that the performance of the obligations of either party is
prevented, restricted or hindered by any event of Force Majeure such party:
(a) shall not be liable to the other party for any damages arising
from any breach of the terms of this Agreement caused by Force
Majeure; and
(b) shall immediately serve notice in writing on the other party
specifying the nature of the Force Majeure, its effect upon
the performance of this Agreement and the period of time in
which it anticipated to apply; and
(c) shall use its reasonable endeavours to overcome the Force
Majeure and resume its proper performance of its obligations
under this Agreement.
14. CONFIDENTIALITY
14.1 Each party undertakes that it will:
(a) keep the existence of and the terms of this Agreement strictly
confidential;
(b) keep all Confidential Information of the other party which may
be within or come into its possession in connection with or
arising from this Agreement or which it may generate in
reliance on any Confidential Information so disclosed, secret
and confidential and it will not at any time for any reason
whatsoever disclose or permit the same to be disclosed to any
third party except as expressly provided in Clause 14.3;
17
(c) use the other party's Confidential Information only as
required to perform its obligations under this Agreement or as
agreed in writing with the disclosing party and for no other
purpose whatsoever.
14.2 The obligations of confidentiality contained in this Clause 14 will not
apply to any part of the Confidential Information of the disclosing
party which the recipient party can show by documentary evidence:
(a) was legally in its possession or control prior to the date on
which it was received from the other party free of any
obligation of confidentiality; or
(b) has come into the public domain or was obtained from a third
party, other than by breach of this Clause 14 or any other
duty of confidence.
14.3 Each party may disclose the other party's Confidential Information:
(a) if and to the extent that any part of that Confidential
Information is required to be disclosed by a regulatory or
government body or court of competent jurisdiction with power
to compel the disclosure provided the disclosing party
notifies the party who owns the Confidential Information of
such requirement, and to the extent possible uses reasonable
endeavours to keep such Confidential Information confidential
notwithstanding any such requirement; and
(b) to its agents, representatives, employees and consultants to
the extent necessary to facilitate the performance of its
obligations under this Agreement provided that any such
disclosure will be limited to what is absolutely necessary in
order to facilitate the performance of this Agreement and the
disclosing party procures that such third parties are bound by
obligations of confidentiality substantially similar to the
provisions of this Clause 14.
14.4 Notwithstanding Clause 14.1(a), CTI may disclose the existence of and
terms of this Agreement (a) to its existing and potential investors if
and to the extent reasonably required by those investors provided that
such third parties are required to keep such information strictly
confidential, and (b) where required, as reasonably determined by CTI,
by applicable law, by applicable stock exchange or Nasdaq regulation or
by order or other ruling of a competent court.
14.5 Without prejudice to any other rights or remedies that the Disclosing
Party may have, the Receiving Party acknowledges and agrees that if the
Confidential Information is used or disclosed other than in accordance
with the terms of this Agreement, the Disclosing Party shall, without
proof of special damage, be entitled to seek an injunction or other
equitable relief for any threatened or actual breach of the provisions
of this Clause, in addition to any damages or other remedy to which it
may be entitled.
14.6 Neither party shall issue a press release or make any other
announcement relating to this Agreement or its terms without the prior
written consent of the other party, except as required by law.
18
14.7 The obligations of both parties under this Clause 14 will survive
termination of this Agreement for any reason.
15. INDEMNIFICATION
15.1 SkyePharma shall indemnify and hold harmless CTI, its Affiliates and
their respective officers, directors, employees and agents (each a "CTI
Party") from and against any and all losses, damages, liabilities or
expenses (including reasonable legal fees and other costs of defence)
("Damages") in connection with any and all actions, suits, claims or
demands that may be brought or instituted against any CTI Party by any
third party relating to (a) personal injury or damage to property to
the extent that such damages are caused by any negligent act or
omission or wilful misconduct of SkyePharma or any of its employees or
agents in manufacturing the Product, or (b) any breach by SkyePharma of
its representations, warranties or obligations pursuant to this
Agreement.
15.2 CTI shall indemnify and hold harmless SkyePharma, its Affiliates and
their respective officers, directors, employees and agents (each an
"SkyePharma Party") from and against any and all Damages in connection
with any and all actions, suits, claims or demands that may be brought
or instituted against any SkyePharma Party by any third party arising
out of or resulting directly or indirectly from the use or distribution
of the Non-Commercial Supplies for any purpose or otherwise in
connection with the Product howsoever and whensoever arising except if
and to the extent that such Damages arise out of a claim of
infringement of a third party's patent rights by the Geomatrix System
or are otherwise within the scope of the indemnification obligation of
SkyePharma under Clause 15.1.
15.3 Each party agrees to give the other party prompt written notice of any
claims made for which the other party might be liable under Clauses
15.1 or 15.2, as the case may be. The indemnifying party shall have the
opportunity to defend, negotiate, and settle such claims provided, that
the indemnified party will be entitled to participate in the defence of
such matter and to engage at its expense independent counsel. The party
seeking indemnification will provide the indemnifying party with such
information and assistance as the indemnifying party may reasonably
request, at the expense of the indemnifying party.
15.4 Neither party will be responsible or bound by any settlement of any
claim or suit made without its prior written consent provided that the
indemnified party will not unreasonably withhold or delay such consent.
15.5 Nothing under this agreement shall require either party to indemnify
the other for indirect or consequential losses or loss of profits
howsoever caused.
15.6 CTI will maintain during the term of this Agreement and for a period of
not less than 5 years after its termination for any reason:
(a) comprehensive general liability insurance written on an
occurrence basis with a combined single limit for bodily
injury and property damage of not less than US$1,000,000; and
19
(b) product liability coverage with a per claim limit of not less
than US$7,500,000;
and in advance of clinical trials and/or marketing and sale of the
Product to any third party the extent of cover shall be increased to
such amounts as are customary and appropriate based upon standards
prevailing in the industry at the time.
15.7 SkyePharma will maintain during the term of this Agreement and for a
period of not less than 5 years after its termination for any reason
comprehensive general liability insurance written on an occurrence
basis with a combined single limit for bodily injury and property
damage of not less than US$[**].
16. NOTICES
16.1 Any notice or other communication in connection with this Agreement (a
"NOTICE") must be in writing, in the English language, and may be
delivered by hand (including by internationally recognised courier),
prepaid airmail, facsimile transmission but not e-mail to the recipient
at the address or facsimile number set out for that party in clause
16.3 or such other address or facsimile number as the recipient has
previously notified to the sender in accordance with this clause 16.
16.2 A Notice shall be deemed to have been duly served:
(a) if delivered by hand, at the time of delivery;
(b) if sent by pre-paid airmail at 10.00 a.m. (local time at the
place of destination) on the fifth Business Day after the day
it was put in the post;
(c) if sent by facsimile, at the time of transmission provided
that a confirming copy is sent by pre-paid airmail within 24
hours after transmission and that no notification informing
the sender that the message has not been delivered has been
received by the sender;
provided that if the Notice is delivered by hand or transmitted by
facsimile and such delivery or transmission occurs after 4.00 pm on a
Business Day or on a day other than a Business Day, service will be
deemed to occur at 9.00 am on the next following Business Day (such
times and dates being local time at the address of the recipient).
16.3 The addresses and facsimile numbers for the parties are as follows:
If to CTI: Critical Therapeutics, Inc.
000 Xxxxxxxxxxxxx Xxx, 00xx Xxxxx
Xxxxxxxxx, XX 00000
Fax no. 000-000-0000
With a copy to: Xxxxxx X. Xxxxxx
Xxxx and Xxxx, LLP
00 Xxxxx Xxxxxx
00
Xxxxxx, XX, 00000
Fax no.: 000-000-0000
If to Jagotec: Xxxxxxxxx Xxxxxxxx, President
Jagotec AG
Xxxxxxxxxxxxxxx 00
XX - 0000 Xxxxxxx
Xxxxxxxxxxx
Tel no.: + 00 00 000 0000
Fax no.: + 00 00 000 0000
With a copy to: Xxxxxxx Xxxxxxxx, General Counsel
SkyePharma PLC
000 Xxxxxxxxxx
Xxxxxx X0X 0XX
XX
Tel no.: x00 (0) 00 0000 0000
Fax no.: x00 (0) 00 0000 0000
17. FURTHER ASSURANCES
The parties hereby undertake and agree to execute and deliver such other
documents, instruments and agreements and to take such other actions as may be
necessary, proper or appropriate to carry out the terms of this Agreement or to
comply with Applicable Laws. If either CTI or SkyePharma so requests in writing,
the parties will promptly file and record with any applicable office or
authority a copy or memorandum of this Agreement and any other agreement
granting SkyePharma rights to manufacture the Products for CTI.
18. ASSIGNMENT
18.1 Except as set out in Clause 18.2, neither party may without the prior
written consent of the other party assign the benefit or delegate the
burden of this Agreement or otherwise sub-contract, transfer, charge or
deal in any other manner with this Agreement or any of its rights and
obligations under it, or purport to do any of the same.
18.2 Notwithstanding Clause 18.1, (a) SkyePharma shall be entitled to assign
its rights under this Agreement to SkyePharma PLC or any subsidiary of
SkyePharma PLC from time to time provided that SkyePharma shall procure
that any subsidiary to whom it assigns any of its rights under this
Agreement shall assign such rights back to SkyePharma immediately prior
to its ceasing to be a subsidiary of SkyePharma PLC provided that such
assignment shall not relieve SkyePharma of any of its obligations under
this Agreement, and (b) CTI shall be entitled to assign its rights
under this Agreement to an Affiliate or in connection with the sale of
all or substantially all of the business and assets of CTI to which the
subject matter of this Agreement pertains.
19. THIRD PARTY RIGHTS
21
19.1 This Agreement does not create any right enforceable by any person who
is not a party, whether pursuant to the Contracts (Rights of Third
Parties) Xxx 0000 or otherwise, except that:
(a) the rights under Clauses 15.1 and 15.2 may be enforced by the
parties referred to in those Clauses subject to and in
accordance with the terms of Clauses 13 and the Contracts
(Rights of Third Parties) Xxx 0000; and
(b) a person who is the permitted successor to or assignee of the
rights of a party is deemed to be a party to this Agreement
and the rights of such successor or assignee shall, subject to
and upon any succession or assignment permitted by this
Agreement, be regulated by the terms of this Agreement.
19.2 Notwithstanding that any term of this Agreement may be or become
enforceable by a person who is not a party to it, the terms of this
Agreement or any of them may be varied, amended or modified or this
Agreement may be suspended, cancelled or terminated by agreement in
writing between the parties or this Agreement may be rescinded, (in
each case) without the consent of any such third party.
20. ENTIRE AGREEMENT
20.1 This Agreement and the documents referred to in it constitute the
entire agreement between the parties relating to their subject matter,
and supersede all prior written or oral agreements, representations or
understandings between the parties relating to that subject matter.
20.2 Each party confirms that, in agreeing to enter into this Agreement, it
has not relied on any representation, warranty, collateral contract or
other assurance except those set out in this Agreement and to the
extent any previous representation, warranty, collateral contract or
assurance was made to a party, that party waives all rights and
remedies in respect of it. Nothing in this Agreement will operate to
limit or exclude a party's liability for fraud.
20.3 All conditions, warranties and other terms implied by statute or common
law are hereby excluded to the fullest extent permitted by law.
21. GENERAL
21.1 Each party will pay its own costs and expenses incurred in connection
with the preparation, negotiation and implementation of this Agreement
and the documents referred to in this Agreement.
21.2 Nothing in this Agreement is intended to or will operate to create a
partnership or joint venture of any kind between the parties, or to
authorise either party to act as agent for the other, and neither party
will have authority to act in the name or on behalf of or otherwise to
bind the other in any way (including but not limited to the making of
any representation or warranty, the assumption of any obligation or
liability and the exercise of any right or power).
22
21.3 No variation or waiver of any of the terms of this Agreement shall be
binding unless set out in writing, expressed to amend this Agreement
and signed by the parties or their duly authorised representatives.
21.4 No failure or delay by any party to exercise any right, power or remedy
will operate as a waiver of it nor will any partial exercise preclude
any further exercise of the same, or of some other right, power or
remedy.
21.5 The rights and remedies provided by this Agreement are cumulative and
(subject as otherwise provided in this Agreement) are not exclusive of
any rights or remedies provided by law.
21.6 This Agreement may be executed in any number of counterparts and all
the counterparts when taken together will constitute one agreement.
Each party may enter into this Agreement by executing a counterpart.
21.7 This Agreement is drawn up and executed in the English language. If
there is any conflict between this Agreement and any translation of
this Agreement, the English language version of this Agreement will
prevail.
21.8 If any provision of this Agreement, or any part of a provision of this
Agreement, is found to be illegal, invalid or unenforceable the
remaining provisions, or the remainder of the provision concerned,
shall continue in effect.
21.9 Each party to this Agreement warrants and represents that such party
has full authority and corporate power to enter into this Agreement, is
aware of no legal, contractual or other restriction, limitation or
condition that might affect adversely its ability to perform hereunder,
and is in good standing under the laws of each jurisdiction in which it
is incorporated or engages in business activities.
22. ARBITRATION
22.1 In the event of a dispute, either party may demand that the dispute be
resolved by the parties' chief executive officers by notifying the
other in writing. Such notice will set out the nature of the dispute
and the party's position. The other party will within 5 Business Days,
submit a statement to the other setting out its position in relation to
the dispute (the "Response"). The negotiations shall take place within
10 Business Days of the Response being served. If a dispute cannot be
resolved within 10 Business Days of commencement of negotiations or the
second party fails to serve a Response either party may instigate
arbitration in accordance with Clause 22.2.
22.2 Any dispute arising out of or in connection with this Agreement
(including any question regarding its existence, validity or
termination), which is not resolved pursuant to Clause 22.1 shall be
referred to and finally (in the absence of substantial irregularity)
resolved by arbitration under the London Court of International
Arbitration ("LCIA") Rules which are deemed to be incorporated by
reference into this Clause 22.2 and the following shall apply:
23
(a) the number of arbitrators in all disputes shall be three, one
to be appointed by each of the Parties and the third
arbitrator (who shall be the chairman of the arbitral
proceedings) being appointed according to the LCIA Rules;
(b) the seat or legal place of arbitration shall be London;
however, the location of arbitral proceedings may vary as the
Parties agree from time to time;
(c) the Parties shall cooperate in good faith to expedite (to the
maximum extent practicable) the conduct of any arbitral
proceedings commenced under this Agreement;
(d) any award shall be final and binding on the Parties and shall
be the exclusive remedy between the Parties regarding any
claims, counterclaims, issues, disputes or accountings
presented to the arbitral tribunal;
(e) the language to be used in the arbitral proceedings shall be
English.
22.3 Nothing in Clause 22 shall preclude either party from seeking interim
or provisional relief, including a temporary restraining order,
preliminary injunction or other interim equitable relief concerning a
dispute, either prior to or during the arbitration, if necessary to
protect the interests of such party.
23. GOVERNING LAW
This Agreement will be governed by and construed in all respects in
accordance with English law.
[Remainder of this Page Intentionally Left Blank.]
24
EXECUTED by the parties on the date specified at the beginning of this
Agreement.
JAGOTEC AG
By: /s/ Xxxxxxxxx Xxxxxxxx
---------------------------------------
Name: Xxxxxxxxx Xxxxxxxx
Position: Director
JAGOTEC AG
By: /s/ Xxxxxxx Halleisen
---------------------------------------
Name: Xxxxxxx Halleisen
Position: Director
CRITICAL THERAPEUTICS, INC.
By: /s/ Xxxx Xxxxx
---------------------------------------
NAME: DR. XXXX XXXXX
POSITION: PRESIDENT AND CHIEF EXECUTIVE OFFICER
25
SCHEDULE 1
THE ZILEUTON REVISED PLAN AND TIMELINE
[**]
26
SCHEDULE 2
THE PATENTS
[**]
27
