EXHIBIT 4.8
Collaboration Agreement
Dated August 9, 1999
Between Human Genome Sciences Inc.
And
Cambridge Antibody Technology Ltd./1/
/1/ [***] indicates that text has been deleted, which is subject to a
confidential treatment request. This text has been filed with the SEC on a
supplemental basis.
COLLABORATION AGREEMENT
This Collaboration Agreement (the "Agreement") is made this 9/th/ day of August
1999 ("Effective Date") by and between Cambridge Antibody Technology, Ltd.,
("CAT") an English corporation having its registered office at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and Human Genome Sciences Inc.
("HGS") a Delaware corporation having its principal offices at ▇▇▇▇ ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America.
WHEREAS, CAT is a leader in the field of rapid human antibody discovery,
engineering and other related activities in the use of antibodies for target
validation, drug design, and the development of proprietary therapeutic
products.
WHEREAS, HGS is a leader in the field of high throughput gene discovery and
cloning and other related activities leading to the discovery and development of
novel drugs.
WHEREAS CAT and HGS wish to collaborate upon the terms and conditions as set out
in this Agreement.
NOW THEREFORE, in consideration of the mutual promises and covenants contained
in this Agreement, the Parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.01 As used throughout this Agreement, the following words and phrases shall
have the meanings ascribed to them in Sections 1.01 through 1.44.
1.02 "Affiliate(s)" means any corporation, company, partnership, joint venture
and/or firm which controls, is controlled by or is under common control
with a Party. "Control" means (a) in the case of corporate entities,
direct or indirect ownership of at least fifty percent (50%) of the stock
or shares entitled to vote for the election of directors; and (b) in the
case of non-corporate entities, direct or indirect ownership of at least
fifty percent (50%) of the equity interest with the power to direct the
management and policies of such non corporate entities.
1.03 "Antibody or Antibodies" means a molecule or a gene encoding such a
molecule comprising or containing one or more immunoglobulin variable
domains or parts of such domains or any existing or future fragments
variants modifications or derivatives thereof.
1.04 "Antigen(s)" means [***] or any future antigen selected by HGS pursuant to
Article 20.
1.05 "BLA" means a Biologic License Application, or other application approving
the marketing of Licensed Product, which is submitted to the FDA or its
equivalent application in a Major Market.
1.06 "CAT Background IP" means Patent Rights, Know-How and Material which CAT
owns
or which CAT is licensed to use which directly relate to the Target
Antibodies at the Effective Date or Improvements which CAT owns after the
Effective Date which directly relate to the Target Antibodies.
1.07 "CAT Antibody Patents" shall mean (1) the Winter II Patent Rights
(European Patent Number (EPO368684/PCT/GB89/01334) and its US equivalents
namely the Winter/▇▇▇▇▇▇ Applications (US Numbers 07/933,958, 07/933,959,
07/941,761, 07/941,762) and their European equivalents and (2) the
▇▇▇▇▇▇▇▇▇▇ Patents Rights (European Patent Number
EPO584877B1/PCTGB91/01134) and U.S. equivalents, and (3) the ▇▇▇▇▇▇▇▇▇
Patent Rights (US Number 5,885,793) and its European equivalents all
licensed to CAT pursuant to the license agreement dated January 7, 1997
between CAT and the Medical Research Council ("MRC").
1.08 "CAT's Third Party Royalty Obligations" means all Royalties payable by
CAT under license agreements with third parties as of the Effective Date
and which cover activities conducted by CAT under the Research Programme
including but not limited to the agreements set out in Appendix B.
1.09 "Clinical Development Antibody" means a Target Antibody which has
achieved In-Vivo Proof of Concept within the Time Line.
1.10 "Clinical Indication" means an area of treatment of a condition in the
Disease Area. Examples of Clinical Indications are, without limitation:
[***].
1.11 "Competing Antibody Product" means a human Antibody owned or licensed by
HGS or a third party which achieves In-Vivo Proof of Concept and which is
directed to a given Target.
1.12 "Confidential Information" means any scientific, technical, trade or
business information disclosed by one Party to the other Party which is
(a) disclosed in writing or other tangible form and labeled
"CONFIDENTIAL" at the time of disclosure or (b) disclosed verbally and
identified as confidential at the time of disclosure and subsequently
summarized and confirmed in writing as confidential within twenty (20)
days of such oral disclosure. "Confidential Information" does not include
information which (a) was known to the receiving Party at the time it was
disclosed, other than by previous disclosure by the disclosing Party, as
evidenced by written records at the time of disclosure; (b) at the time
of disclosure or later becomes publicly known under circumstances
involving no breach of this Agreement; (c) is lawfully and in good faith
made available to the receiving Party by a third party who did not derive
it from the disclosing Party and who imposes no obligation of confidence
on the receiving Party; (d) is developed by the receiving Party
independent of any disclosure by the disclosing Party, as evidenced by
the receiving party's written records or (e) is required by law or
regulation to be disclosed.
1.13 "Development Plan" means a detailed Report prepared by HGS pursuant to
Clause 11 in
respect of each Clinical Development Antibody which contains estimated
timelines for the development and commercialisation of a Licensed Product
together with the dates by which HGS believes in good faith it can: (i)
initiate Phase I / IIa clinical trials, (ii) initiate Phase III clinical
trials, and (iii) file a BLA in a Major Market ("the HGS Milestones").
1.14 "Diagnostic Licensed Products" means any product in the form of a device
compound kit or service with utility in the diagnosis prognosis
prediction or monitoring of progress of a disorder (1) incorporating part
of at least one variable region of a Target Antibody or (2) whose
biological activity was identified by a Target Antibody and whose
potential medical utility was first demonstrated by a Target Antibody.
1.15 "Disease Areas" mean (a) Malignant disease of cells of a [***], (b)
Nonmalignant disease of cells of the [***], (c) Malignant disease of
cells of the [***] and (d) Nonmalignant disease of cells of the [***].
1.16 "FDA" means the United States Food and Drug Administration or any
successor United States governmental agency or any other foreign
governmental agency performing similar regulatory functions with respect
to pharmaceutical Licensed Products in a Major Market.
1.17 "Field" means any human therapeutic or diagnostic use.
1.18 "First Commercial Sale" means the first sale or other disposition for
value of the Licensed Products, in a final dosage form, to an independent
third party following regulatory approval. The term "First Commercial
Sale" shall not include sales and disposals for experimental purposes or
for purposes of clinically or otherwise testing any Licensed Product.
1.19 "FTE" shall mean a full time equivalent employee assigned to the Research
Programme.
1.20 "HGS Background IP" means Patent Rights, Know-How and Material which HGS
owns or which HGS is licensed to use which directly related to the Target
at the Effective Date.
1.21 "HGS Know-How" means all unpatented information, whether or not
patentable, relating to Materials, methods, processes, techniques and
data for the development, manufacture, use or sale of the Target, Target
Antibodies or Licensed Product which is known to HGS or developed
independently by HGS or received by HGS from a third party and not from
CAT at any time during the Term of this Agreement and which HGS if free
to transfer or disclose without violating contractual obligations to any
third party.
1.22 "Improvement" means any improvements, modifications and adaptations
(whether patentable or otherwise) to any party of either CAT Background
IP or HGS Background IP which may arise in connection with performance of
the Research Programme. It is recognized and agreed that a Target
Antibody or Clinical Development Antibody and any improvements,
modifications or adaptations to such Antibody will not be considered
Improvements for the purposes of this Agreement.
1.23 "In-Vivo Proof of Concept" means an objective demonstration of the
efficacy of a Target Antibody as agreed by the JMC. In respect of Target
1 it means demonstration of the efficacy of a Target Antibody in an
animal model which has been specified by HGS and agreed not later than
[***] from the Effective Date.
1.24 "Management Committee" means the Joint Management Committee established
pursuant to the terms of Article 4.
1.25 "Know-How" means all unpatented information, whether or not patentable,
relating to materials, methods, processes, techniques and data for the
development, manufacture, use or sale of the Target, Target Antibodies or
Licensed Product which is known to a Party and which a Party is free to
transfer or disclose without violating contractual obligations to any
third party.
1.26 "Licensed Product(s)" means Therapeutic Licensed Products, Therapeutic
Antibody Licensed Products and Diagnostic Licensed Products.
1.27 "Insolvency Event" in relation to either Party, means any one of the
following: (i) a notice shall have been issued to convene a meeting for
the purpose of passing a resolution to wind up that Party or such a
resolution shall have been passed other than a resolution for the solvent
reconstruction or reorganisation of the Party of for the purpose of
inclusion of any part of the share capital of that Party in the Official
List of the London Stock Exchange or in the list of the American Stock
Exchange or quotation of the same on the National Association of
Securities Dealers Automated Quotation System; or (ii) a resolution shall
have been passed by that Party's directors to seek a winding up or
administration order or a petition for a winding up or administration
order shall have been presented against that Party or such an order shall
have been made; or (iii) a receiver, administrative receiver, receiver or
manager, interim receiver, custodian, sequestrator or similar officer is
appointed in respect of that Party or over a substantial part of its
assets or any third party takes steps to appoint such an officer in
respect of that Party of an encumbrance takes steps to enforce or
enforces its security; or (iv) a proposal for a voluntary arrangement
shall have been made in relation to that Party under Part I Insolvency
▇▇▇ ▇▇▇▇; or (v) a step or event shall have been taken or arisen outside
the United Kingdom which is similar or analogous to any of the steps or
events listed at (i) to (iv) above; or (vi) that Party takes any step
(including starting negotiations) with a view to readjustment,
rescheduling or deferral of any part of that Party's indebtedness, or
proposes or makes any general assignment, composition or arrangement with
or for the benefit of all or some of that Party's creditors or makes or
suspends or threatens to suspend making payments to all or some of that
Party's creditors of the Party submits to any type of voluntary
arrangements; or (vii) where that Party is resident in the United Kingdom
it is deemed to be unable to pay its debts within the meaning of ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇.
1.28 "Major Market" means United States, European Community, France, Italy,
Germany, the United Kingdom or Japan.
1.29 "Material" means any chemical or biological substance, including but not
limited to any: (a) organic or inorganic chemical element or compound;
(b) nucleotide or nucleic acid sequence, including DNA and RNA sequences,
derived by natural or synthetic means; (c) gene; (d) vector or construct,
including but not limited to plasmids, phagemids, phages or viruses; (e)
host organism, including bacteria, fungi, algae, protozoa and yeast; (f)
other genetic material or micro-organism; (g) gene product, including but
not limited to any peptide or amino acid sequence, protein, enzyme or
antibody and any fragment thereof conferring targeting properties in
vitro and/or in vivo; (h) eukaryotic or prokaryotic cell line or
expression system or any development strain or produce of that cell line
or expression system; (i) Antibody or Antibody producing cell line,
including hybridomas; (j) drug or pro-drug; or (k) assay or reagent.
1.30 "Net Sales" means the amounts invoiced on the sales of Licensed Product
or Non-Antibody Product by HGS, its sublicencees and Affiliates to
independent, unrelated third parties in bona fide arms length
transactions, less the following deductions properly documented actually
allowed and taken by such third parties and not otherwise recovered by or
reimbursed by HGS, its Affiliates or sublicencees: (a) trade, cash and
quantity discounts, including charge backs; (b) taxes on sales (such as
sales or use taxes) to the extent added to the sales price and set forth
separately as such in the total amount invoiced; (c) freight, insurance
and other transportation charges to the extent added to the sales prices
and set forth separately as such in the total amount invoiced; (d)
amounts repaid or credited by reason of rejections, defects or returns,
or because of retroactive price reductions, or due to governmental laws
or regulations requiring rebates; (e) import duties; and means further
the amount of fair market value of all other consideration received by
HGS, or its sublicencees or Affiliates in respect of the Licensed Product
or Non-Antibody Product, whether such consideration is in cash, payments
in kind, exchange or other forms; but does not mean sales of the Licensed
Product or Non-Antibody Product between or among HGS and its sublicencees
and/or Affiliates. In the event a Licensed Product or Non-Antibody
Product is sold in combination with other active components ("Combination
Licensed Products"), Net Sales for purposes of royalty payments on the
Combination Licensed Products shall be calculated by multiplying the Net
Sales of the Combination Licensed Product by the fraction A/(A+B), where
A is the gross selling price of the Licensed Product sold separately
(i.e. without the other active components) and B is the gross selling
price of the other active components. In the event that no such separate
sales are made Net Sales for royalty payments shall be calculated by
multiplying Net Sales of the Combination Licensed Product by C/(C+D)
where C is the fully allocated cost of the Licensed Product (not
including the other active components) and D is the fully allocated cost
of such other active components such costs being determined using
generally accepted accounting procedures consistently applied.
1.31 "Non-Antibody Product" means any product in whatever form (including
without limitation bulk active formulated or unformulated bulk, final or
packaged and final
labelled forms) for any human therapeutic or diagnostic use which is not
a Licensed Product or a Competing Antibody Product.
1.32 "Patent Rights" means patent applications or patents, author
certificates, inventor certificates, utility certificates, improvement
patents and models and certificates of addition, and all foreign
counterparts of them and includes divisions renewals continuations,
continuations-in-part, extensions, reissues, substitutions,
confirmations, registrations revalidation or additions of or to them as
well as any supplementary protection certificate or any other post patent
expiry extension of patent protection in respect of them.
1.33 "Research Programme" shall have the meaning set forth in Article 2 with
respect to the research and development done with respect to each Target.
1.34 "Research Programme IP" means all Patent Rights and Know-How that arises
under the Research Programme.
1.35 "Research Programme Support Payment" shall mean the payments made by HGS
to CAT in support of the Research Programme.
1.36 "Target" shall mean the Antigen(s) for which CAT and HGS have agreed to
conduct a collaborative Research Programme pursuant to Article 2 of this
Agreement.
1.37 "Target Antibodies" means an Antibody or Antibodies derived under the
Research Programme to the Target.
1.38 "Target 1" shall mean [***].
1.39 "Target 2" and "Target 3" means the Target(s) corresponding to each
subsequent Antigen designated by HGS pursuant to Clause 20 of the
Agreement.
1.40 "Technical Performance Criteria" means for Target 2 and Target 3 such
Technical Performance Criteria as shall be agreed by the JMC in respect
of each such Target.
1.41 "Time Line" means the period agreed by the JMC by which the Clinical
Development Antibody shall be completed. In respect to Target 1 it shall
be 12 months from the Effective Date.
1.42 "Term" means the term of this Agreement under Article 18.
1.43 "Therapeutic Antibody Licensed Products" means all products in whatever
form (including without limitation bulk active, formulated or
unformulated bulk, final or packaged, and final labelled forms) for any
human therapeutic incorporating part of at least one variable region of a
Target Antibody.
1.44 "Therapeutic Licensed Products" means all products in whatever form
(including without limitations bulk active, formulated or unformulated
bulk, final or packaged, and final labeled forms) for any human
therapeutic whose biological activity was identified by a Target Antibody
and whose potential medical utility was first demonstrated by a Target
Antibody.
ARTICLE 2 RESEARCH PROGRAMME
2.01 CAT and HGS will conduct collaborative research and development with
respect to Target 1 and to each subsequent Target designated pursuant to
Clause 20 ("the Research Programme").
2.02 Each Party will mutually disclose all information concerning Target
Antibodies and the Target, which is necessary for each to perform their
duties under the Research Programme, including information relating to
selection, derivation and assays relating to Target Antibodies and the
Target as developed under the Research Programme. HGS shall specify the
animal model for demonstration of In-Vivo Proof of Concept in respect of
Target 1 not later than [***] after the Effective Date. HGS shall specify
the animal model for demonstration of In-Vivo Proof of Concept in respect
of Targets 2 and 3 by a date to be agreed by the JMC.
2.03 The Parties will establish a Joint Management Committee ("JMC") pursuant
to Article 4 and each Party shall fund its own costs of the Research
Programme. The Parties will collaborate and if required by the JMC
employees will work with employees of the other Party at that Party's
premises.
2.04 The purpose of the Research Programme will be to generate diverse panels
of Target Antibodies and to use them to explore in vivo and in vitro
biological characteristics and disease association of the Target and to
generate a lead Target Antibody for pre-clinical and subsequent
development of a Clinical Development Antibody.
2.05 The parties shall use reasonable efforts to fulfill their obligations as
set out in Exhibit A to develop a Clinical Development Antibody and in
respect of Targets 2 and 3 to meet any applicable Technical Performance
Criteria in respect of Targets 2 and 3.
ARTICLE 3 PRE-CLINICAL DEVELOPMENT
3.01 After the development of a Clinical Development Antibody HGS shall be
solely responsible for all further pre-clinical development costs. If HGS
requires additional work to be done by CAT with respect to a Clinical
Development Antibody on terms to be mutually agreed by the JMC CAT agrees
to perform such work and HGS agrees to reimburse CAT for its costs at the
rate of [***] per FTE for Target 1. For Targets 2 and 3 the FTE rates
shall be mutually agreed.
ARTICLE 4 JOINT MANAGEMENT COMMITTEE
4.01 Promptly after the Commencement Date, the Parties shall establish a JMC
which shall oversee the Research Programme and supervise all other aspects
of the collaboration hereunder. Certain specific functions of the JMC are
as follows:
(a) to design a work plan for each Target Antibody including performance
criteria in respect of any further Antigens selected pursuant to Clause 20
("Technical Performance Criteria") and to select the Time Line, the
appropriate definition of In-Vivo Proof of Concept for Targets 2 and 3 and
any Clinical Indications;
(b) allocate the work between the Parties and, if appropriate, third
parties; oversee the performance of the Research Programme and monitor
progress against the timetables of each Target;
(c) hold review meetings on progress in the Research Programme not less
than once every three calendar months and at any time upon the mutual
agreement of both Parties;
(d) provide a written report on the progress of the Research Programme
once every three months to HGS and CAT management;
(e) identify any patentable inventions or other intellectual property
requiring protection arising out of the Research Programme;
(f) amend the Research Programme from time to time as may be necessary or
desirable; and
(g) determine when the obligations of Parties in respect of the Research
Programme have been carried out and when that Research Programme is
completed.
4.02 The JMC shall be established and run by the Parties as follows:
(a) the JMC shall be comprised of four persons ("Members") and HGS and
CAT shall each be entitled to appoint two Members, to remove any Member
appointed by it and to appoint any person to fill a vacancy arising from
the removal or retirement of such Member;
(b) HGS and CAT shall each notify the other in writing of the identities
of their Members from time to time. Both Parties shall use reasonable
endeavours to keep the same Members on the JMC throughout the duration of
the Research Programme;
(c) the quorum for meeting of the JMC shall be two Members, provided that
there is at least one Member from each of HGS and CAT present;
(d) the JMC shall meet promptly after the Commencement Date. The venue
for all meetings shall be agreed in advance and will generally alternate
between the U.K. and U.S.A., unless audio and video conferences are used.
Each Party shall be responsible for its own expenses, including travel and
accommodation costs incurred in connection with JMC meetings;
(e) the Minutes of each meeting shall be kept, approved by the JMC and
distributed to the Parties. The JMC shall appoint a secretary for each
meeting who need not be a member of the JMC. Such appointment shall
alternate between CAT and HGS. The Secretary shall provide an agenda seven
days prior to the meeting and circulate minutes of the meeting within
fourteen days after the meeting.
4.03 Decisions of the JMC shall be made by unanimous agreement of all the
Members present at the meeting at which there is a quorum. If agreement
cannot be reached then the
Parties shall discuss the position in good faith in an effort to resolve
their differences. If it is not possible to obtain agreement, then either
Party may require that the outstanding matters requiring resolution shall
be deferred to the CEOs of the Parties (or their nominees) for resolution,
who together shall use reasonable efforts to resolve such matters
promptly.
ARTICLE 5 INTELLECTUAL PROPERTY OWNERSHIP
5.01 Nothing in this Agreement transfers or licenses any right, title or
interest to CAT Background IP or HGS Background IP save as expressly set
out herein.
5.02 Any and all Research Programme IP shall be owned by HGS from the moment of
its development or other origination, and CAT hereby assigns and will
assign any and all rights, title and interest in Research Programme IP to
HGS.
5.03 Provided however that any and all Improvements shall be owned by the Party
who owns the underlying technology to which the Improvements are made
regardless of which Party makes the Improvement.
ARTICLE 6 GRANTS, RESERVED RIGHTS AND EXCLUSIVITY
6.01 CAT grants to HGS a royalty free non-exclusive worldwide license under the
CAT Background IP solely to carry out the Research Programme.
6.02 CAT grants to HGS an option ("the Option") to a world-wide royalty bearing
exclusive sub-licensable license under the CAT Background IP to develop,
make, have made, use and have used, import, sell and have sold Licensed
Product for use in the Field. Subject to 6.03 if CAT develops a Clinical
Development Antibody then HGS shall exercise its option provided that HGS
had paid the Research Programme Support Payment pursuant to Article 7.
However if (1) CAT does not develop a Clinical Development Antibody or (2)
if HGS has not exercised its Option within the Time Line then the Option
shall lapse.
6.03 In the event the [***] then there shall be no obligation for the parties
to be exclusive to each other and in the event that HGS does not exercise
its Option then the obligations of Article 11 shall not apply.
6.04 Subject to Clause 6.03 if CAT develops a Clinical Development Antibody
then neither party shall develop Antibodies against the Target for the
Clinical Indication identified by the JMC in the In-Vivo Proof of Concept
with any third parties and shall be exclusive to each other in the future
development and commercialisation of Target Antibodies to that Target for
the Clinical Indication identified by the JMC.
6.05 Subject to Clause 6.03 if CAT develops a Clinical Development Antibody
then both parties shall use their good faith effort to assess whether the
Clinical Development Antibody may be appropriate for a different Clinical
Indication pursuant to the provisions
of Clause 3.01. In the event that the [***] then the parties shall have no
obligation to be exclusive to each other in respect of the development and
commercialization for that different Clinical Indication. In assessing
whether a Competing Antibody Product performs better the JMC shall base
its decision on objective criteria such as [***] of the Clinical
Development Antibody and the Competing Antibody Product as deemed
appropriate. If the JMC cannot agree within [***] they shall refer the
decision to the Chief Executive Officers of the parties or their appointed
representative. If they cannot agree within [***] from the referral to the
CEOs then the parties shall appoint an expert whose decision shall be
binding on both the parties.
6.06 In the event a Clinical Development Antibody does not achieve a mutually
agreed pre-defined clinical endpoint and HGS stops development of the
Clinical Development Antibody in that Clinical Indication then HGS's
license shall be converted to a non-exclusive license and the parties
shall no longer be exclusive to each other in respect of that Clinical
Development Antibody in that Clinical Indication.
6.07 HGS grants to CAT a royalty free non exclusive worldwide license under the
HGS Background IP and Research Programme IP solely to carry out the
Research Programme for the benefit of HGS.
6.08 Except for the research right granted under 6.01 HGS shall have the right
to sublicense any and all of the rights provided that it shall notify CAT
within [***] of the grant of any sublicense and that HGS shall not have
the right to sublicense the right to select or engineer Target Antibodies.
ARTICLE 7 RESEARCH PROGRAMME SUPPORT, ROYALTIES AND MILESTONES
7.01 HGS shall pay to CAT a Research Programme Support Payment which in respect
of Target 1 shall be [***] for the support required to fulfil its
obligations, deemed equivalent to at least [***] FTEs. Payment shall be
made in advance on a monthly basis for the first [***] from the Effective
Date at a rate of [***] per month. Thereafter the balance due shall be
payable [***].
7.02 In the event that HGS in its sole discretion notifies CAT that it wishes
to designate a Target Antibody candidate as a Clinical Development
Antibody at any time prior to achievement of In-Vivo Proof of Concept HGS
shall pay CAT the balance of any unpaid Research Programme Payment
Support. In no event shall CAT receive more than [***] by operation of
this clause.
7.03 CAT shall have the sole responsibility for payment, and shall pay all of
CAT's Third Party Royalty Obligations owed on Licensed Products under this
Agreement.
7.04 HGS shall pay to CAT the following milestones with respect to Therapeutic
Licensed Products and Therapeutic Antibody Licensed Products for the
following events in a
Major Market:
- Initiation of the first Phase I/IIa clinical trial [***]
- Initiation of the first Phase III clinical trial [***]
- Filing of a BLA for the first Clinical
Indication in the first Disease Area [***]
- Approval by the FDA of the first Clinical
Indication in the first Disease Area [***]
- Approval by the FDA of a Clinical
Indication in a second Disease Area [***]
HGS shall pay to CAT royalty payments of [***] of Net Sales of Therapeutic
Antibody Licensed Products by HGS or its Affiliates or sublicensees. HGS
shall pay to CAT royalty payments of [***] of Net Sales of Therapeutic
Licensed Products by HGS or its Affiliates or sublicensees.
7.05 If the parties agree that royalties should be paid to third parties other
than CAT's Third Party Royalty Obligations to practise or have practised
the technology claimed in the CAT Antibody Patents such royalties will be
borne equally by HGS and CAT and HGS shall be able to offset its share of
such third party royalties against the royalties owed to CAT under Clause
7.04 provided however that the royalties payable to CAT on Therapeutic
Antibody Licensed Products pursuant to Clause 7.04 shall not be reduced
below [***] of Net Sales in any year for which a royalty is owed to CAT.
It is agreed and acknowledged that the provisions of this section shall
not apply to third party royalty payments outside the scope of the CAT
Antibody Patents nor shall it apply to royalties payable in respect of
Therapeutic Licensed Products, Diagnostic Licensed Products or Non-
Antibody Products.
7.06 HGS shall pay to CAT the following milestones with respect to Diagnostic
Licensed Products for the following events in a Major Market:
- Filing of PMA or 510k US$ [***]
- Approval by the FDA US$ [***]
7.07 HGS shall pay to CAT royalty payments in respect of Net Sales of
Diagnostic Licensed Products equal to the amount of [***].
7.08 Subject to Clause 7.04 in the event that HGS, its affiliates or
sublicensees require additional licenses from third parties in order to
develop manufacture or commercialise a Licensed Product or a Non-Antibody
Product any consideration or royalties payable shall be the sole
responsibility of HGS, its Affiliates or Sublicensees and shall not be
creditable against any royalty or other payments due to CAT under this
Agreement.
7.09 All royalties shall be payable until the later of 10 years from the date
of the First Commercial Sale or until the expiry of the last of the
patents in the CAT Background IP
which patents would be infringed by a Licensed Product.
ARTICLE 8 PAYMENTS
8.01 HGS shall make payments to CAT with respect to the sale of Licensed
Product by HGS, its sublicensees and its affiliates, on a country-by-
country basis, commencing six months after the First Commercial Sale and
to continue every six months thereafter. Such payments shall be due forty-
five days after the close of each six month period.
8.02 Each payment or credit shall be accompanied by a report setting forth the
calculations of the amounts to be paid or credited on a country-by-country
basis.
8.03 All payments shall be in United States dollars. Payments due on Net Sales
made in currency other than United States dollars shall first be
calculated in the foreign currency and then converted to United States
dollars on the basis of the monthly average exchange rate for the
preceding six months in effect in the purchase of United States dollars
with such foreign currency as set forth in the Key Currency Cross Rates
Tables of the Wall Street Journal (or comparable publication if not quoted
in the Wall Street Journal) with respect to the currency of the country of
origin of such payment prior to the date of payment.
8.04 HGS shall maintain true and complete books of account for a period of 3
years containing an accurate record of all data necessary for the proper
computation of payments due from it or charges made by it under this
Agreement.
8.05 Upon request by CAT, HGS agrees to make such books of account available,
upon reasonable notice and at reasonable times, for inspection by an
independent Certified Public Accounting firm which is acceptable to both
parties. Such inspection may take place at any time within 3 years after
the date of payment or charges to which they relate (but not more than
once in each calendar year) for the sole purpose of verifying the amount
of such payments or charges and the accuracy of such books of account.
8.06 The fees and expenses of the audit shall be borne by CAT, unless a net
discrepancy of more than [***] in CAT's favor is discovered in which case
HGS shall bear the fees and expenses. If any such audit shows any
underpayment or overpayment, a correcting payment or credit, respectively,
shall be made within thirty days after receipt of the written statement of
the audit.
8.07 Any income or other tax that HGS, its Affiliates or sublicensees are
required by law to withhold and pay on behalf of CAT with respect to
Royalties paid to CAT under this Agreement shall be deducted from said
Royalties prior to remittance to CAT; provided however, that in regard to
any such tax so deducted, HGS, its Affiliates or sublicensees shall give
or cause to be given to CAT such assistance as may reasonably be necessary
to enable CAT to claim exemption therefrom or credit therefor, and in each
case shall furnish CAT proper evidence of such taxes paid on its behalf.
8.08 All payments made to CAT under the Agreement shall be made to the account
of Cambridge Antibody Technology Limited at [***] by telephonic transfer.
8.09 If HGS fails to make any payments to CAT hereunder within 15 days on the
due date for payment, without prejudice or any other right or remedy
available to CAT, CAT shall be entitled to charge HGS interest (both before
and after judgement) on the amount unpaid at the rate or LIBOR [***]
calculated on a daily basis until payment in full is made without prejudice
to CAT's right to receive payment on the due date.
ARTICLE 9 LIABILITY
9.01 Each Party (the "Indemnifying Party") shall be responsible for and
indemnify the other Party and its Affiliates and their officers, servants
and agents (collectively the "Indemnified Party") against any and all
liability, loss, damage, cost or expense incurred or suffered by the
Indemnified Party as a result of a claim that use of any Licensed Product
or Non-Antibody Product supplied or made available by the Indemnifying
Party has caused death or bodily injury except where the claim arises
through the negligence or intentional wrongdoing of the Indemnified Party.
An Indemnified Party that intends to claim indemnification under this
Clause shall promptly notify the Indemnifying Party of any claim, loss,
damage, or expense in respect of which the Indemnified Party intends to
claim indemnification reasonably promptly after the Indemnified Party
becomes aware of its claim. The Indemnifying Party shall assume the
defense of any related third-party action, suit or proceedings with counsel
mutually satisfactory to the Parties; provided, however, that an
Indemnified Party shall have the right to retain its own counsel with the
fees and expenses to be paid by the Indemnifying Party, if representation
of that Indemnified Party by the counsel retained by the Indemnifying Party
would be inappropriate due to actual or potential differing interests
between the Indemnified Party and any other party represented by that
counsel in the proceedings. The indemnity in this Clause shall not apply
to amounts paid in settlement of any claim, loss, damage or expense if that
settlement is effected without the consent of the Indemnifying Party, which
consent shall not be unreasonably withheld. The failure of an Indemnified
Party to deliver notice to the Indemnifying Party within a reasonable time
after becoming aware of any claim, loss, damage or expense in respect of
which it intends to claim indemnification under this Clause, if prejudicial
to the Indemnifying Party's ability to defend the action, shall relieve the
Indemnifying Party of any liability to the Indemnified Party under this
Clause. The Indemnifying Party shall not have any liability to any
Indemnified Party otherwise than under this Clause. The Indemnified Party
and its employees and agents shall cooperate fully with the Indemnifying
Party and its legal representatives in the investigation of any matter
covered by this indemnification.
9.02 Neither Party shall be liable to the other in contract, tort, negligence,
breach of statutory duty or otherwise for any economic loss or other loss
or turnover, profits, business or goodwill or any loss, damages, costs or
expenses of any nature whatsoever incurred or suffered by the other or its
Affiliates of an indirect or consequential nature arising out of or in
connection with this Agreement.
9.03 The maximum limit of CAT's liability under this Agreement shall be the
amounts paid by HGS to CAT hereunder provided however that this clause will
not be applicable if CAT receives a licence from HGS pursuant to the
provisions of Clause 11.03.
9.04 During the term of this Agreement and for a period of [***] following the
expiration or earlier termination of this Agreement HGS shall maintain
adequate liability insurance, including Licensed Product liability and
contractual liability insurance each with coverage of [***] for each claim
and in the aggregate to cover HGS's obligations under this Agreement. Such
insurance cover shall be maintained with a nationally recognised insurance
carrier reasonably acceptable to CAT.
ARTICLE 10 CONFIDENTIALITY
10.01 The receiving party will retain all of the Confidential Information in
confidence during the term of this Agreement and for a period of five
years after termination of this Agreement and will not, without the
prior written permission of the other party or pursuant to Article 10
hereof, disclose it to third parties, or use it for any purpose other
than in accordance with the terms of this Agreement.
10.02 Each party shall have the right to disclose to others Confidential
Information to the extent such disclosure is reasonably necessary, in
filing or prosecuting patent applications, prosecuting or defending
litigation, complying with governmental regulations, conducting
preclinical or clinical trials, or seeking approval from or complying
with the FDA, provided that if a party is required to make any non-
confidential disclosure of the other party's Confidential Information,
the disclosing party will give reasonable advance notice to the other
party of such disclosure requirement, and will use reasonable efforts
to secure confidential treatment of such Confidential Information
required to be disclosed.
ARTICLE 11 DUE DILIGENCE
11.01 Subsequent to the development of a Clinical Development Antibody HGS will
prepare and deliver a Development Plan to CAT. HGS will use reasonable
efforts to meet the HGS Milestones set out in the Development Plan and
to develop marketable Licensed Products of good merchantable quality,
including reasonable efforts to develop Licensed Products in multiple
Clinical Indications of a Disease Area, and to bring those Licensed
Products to market within the time set out in the Development Plan and
to satisfy market demand for those Licensed Products.
11.02 Subsequent to the development of a Clinical Development Antibody if HGS
its Affiliate or sublicensee does not file an application with the FDA
for permission to test in humans (or where a filing is not required
has not initiated human Clinical trials) and HGS its Affiliates or
sublicensees by itself or with a third party develops a Non-Antibody
Product which is a competing antagonist of [***] action in a Clinical
Indication then HGS shall pay to CAT the following milestone payments:
- Initiation of the first Phase III clinical trial US$[***]
- Filing for approval of a BLA in the first Clinical
Indication US$[***]
- Approval of the first Clinical Indication US$[***]
- Approval of a Clinical Indication in
subsequent Disease Area US$[***]
In addition HGS shall pay CAT Royalties on Net Sales of Non-Antibody
Products of [***]
11.03 If HGS (a) within [***] from the delivery of a Clinical Development
Antibody does not file an application with the FDA for permission to
test in humans a Licensed Product or a Non-Antibody Product in the
field of antagonists to action of the Antigen or where a filing is not
required has not initiated human clinical trials or (b) notifies CAT
that it is not initiating or terminating all clinical trials in the
field of an antagonist to a Target then the Licenses granted to HGS
shall terminate and HGS shall grant to CAT under HGS Background IP,
Research Programme IP and HGS Know How a world-wide royalty bearing
exclusive sub-licensable license to develop, make, have made, use and
have used, import, sell and have sold the Licensed Product
incorporating such Clinical Development Antibody for use in the Field
and provide CAT with all Material and related data to the Clinical
Development Antibody.
11.04 If the Licenses referred to above are granted then CAT shall pay to HGS
any future applicable milestones as set out in Article 7 and a Royalty
of [***] on Therapeutic Licensed Products and [***] on Net Sales of
Diagnostic Licensed Products.
ARTICLE 12 PUBLICATIONS
12.01 The parties agree that any proposed publications (including, but not
limited to abstracts posters and the like) or public disclosure on the
research conducted under this Agreement shall be submitted to the
other party at least thirty days prior to submission to a journal or
other third party. A proposed submission or disclosure shall be
reviewed promptly; however, where necessary, submission of disclosure
may be delayed for an additional ninety days following the initial
thirty day period for the purposes of preparing related patent
applications and for deleting particularly Confidential Information
from said proposed disclosure if in the reasonable judgment of the
other party such patent applications are considered necessary and
disclosure would jeopardize potential protection.
ARTICLE 13 GOVERNING LAW
13.01 This Agreement shall be governed by and construed in accordance with the
law of England.
ARTICLE 14 PATENT PROSECUTION AND INFRINGEMENT
14.01 HGS shall have the sole right and responsibility, at its sole discretion
and with reasonable assistance from CAT, for the filing of and any
prosecution and maintenance of patents and any other rights related to
the Research Programme IP and for the conduct of any claims or
proceedings relating to them in all countries, including any
interference or opposition proceedings. All applicable costs,
including that of the patent attorneys retained by HGS, shall be the
responsibility of HGS.
14.02 Each Party shall promptly report in writing to the other during the term
of this Agreement any (i) known infringement or suspected infringement
of any of the Research Programme IP or (ii) unauthorised use or
misappropriation of the Confidential Information by a third party of
which it becomes aware, and shall provide the other party with all
available evidence supporting said infringement, suspected
infringement or unauthorised use or misappropriation.
14.03 If during the term of this Agreement if a third party in any country where
the Licensed Product is being imported, manufactured, used, or sold,
notifies any of the Parties, their Affiliates or licensees that such
activity infringes or is alleged to infringe any issued patent either
assigned to or licensed to such third party, then the Party so
notified shall promptly notify the other Party in writing.
14.04 Each Party shall co-operate with the other Party, to the extent reasonably
requested, in any legal action brought by or against the other Party
or both of them or against their Affiliates or sublicensees in
connection with the making, using or selling of Licensed Product(s)
("Action").
14.05 HGS shall have the sole responsibility at its sole expense to defend or
prosecute any Action. CAT shall provide all reasonable assistance in
connection with any Action at HGS expenses (including CAT's reasonable
attorneys' fees). If HGS finds it necessary to join CAT in such suit
or action. CAT shall execute all papers and perform such other acts as
may be reasonably required. Unless HGS and CAT otherwise agree any
amount recovered in any such action or suit whether by judgement or
settlement shall be retained by HGS. In the event HGS fails to take
action within ninety days of learning of such infringement, CAT shall
have the sole right, but not obligation, to bring, defend and maintain
any appropriate suit or action involving infringement of such a patent
by manufacture, use or sale of the Licensed Product. If CAT finds it
necessary to join HGS in such suit or action, HGS shall execute all
papers and perform such other acts as may be reasonably required. HGS
may, at its option, join as a party in such suit and, at its expense,
be represented by counsel of its choice. Unless HGS and CAT otherwise
agree, any amount recovered in any such action or suit, whether by
judgement or settlement, [***].
14.06 HGS shall ▇▇▇▇ the Licensed Products or Non-Antibody Products sold in the
United States with all applicable patent numbers. All Licensed
Products or
Non-Antibody Products shipped to and/or sold in other countries shall
be marked and labelled in such a manner as to conform with all
applicable laws of the country where the Licensed Products or Non-
Antibody Products are sold.
ARTICLE 15 DISPUTE RESOLUTION
15.01 All other disputes between the Parties arising out of the circumstances
and relationships contemplated by this Agreement including disputes
relating to the validity, construction or interpretation of this
Agreement and including disputes relating to pre-contractual
representations shall be in the first instance referred to the
respective Chief Executive Officers of the Parties. If they fail to
agree then any dispute shall be settled by arbitration as follows:
15.02 The arbitration shall be conducted in the English language in accordance
with the Commercial Arbitration Rules of the International Chamber of
Commerce (ICC). The arbitration shall be conducted by one arbitrator
chosen by mutual agreement of the parties. If the parties are unable
to agree on an arbitrator, they shall each pick one arbitrator and the
two arbitrators shall choose a third arbitrator. The parties will
cooperate with each other in using the arbitration to be held in as
efficient and expeditious a manner as practicable. Any arbitration
proceeding instituted under this Agreement shall be brought in London,
England if instituted by HGS and in Washington D.C. if instituted by
CAT.
15.03 Any award rendered by the arbitrator(s) shall be final and binding upon
the parties hereto. Judgement upon the award may be entered in any
court of record of competent jurisdiction. Each party shall pay its
own expenses of arbitration and the expenses of the arbitrator(s)
shall be equally shared unless the arbitrator(s) assesses as part of
his, her or their award all or any part of the arbitration expenses of
one party (including reasonable attorney's fees) against the other
party.
ARTICLE 16 WARRANTIES
16.01 Each Party represents and warrants to the others as follows:-
(a) HGS represents and warrants that it is a corporation, duly organised,
validly existing and in good standing under the laws of the Delaware, and
has all requisite corporate power and authority to execute, deliver and
perform this Agreement. CAT represents and warrants that it is a
corporation, duly organised, validly existing and in good standing under
the laws of England and Wales and has all requisite corporate power and
authority to execute, delivery and perform this Agreement;
(b) This Agreement when executed and delivered by the Parties will be
legal, valid and binding obligation of such Party, enforceable against such
Party in accordance with its terms; and
(c) The execution, delivery and performance of this Agreement by either
Party does not
conflict with, or constitute a breach or default under, (i) the charter
documents of such party, (ii) any law, order, judgement or governmental
rule or regulation applicable to such Party or its property, or, (iii) any
provision of any agreement, contact, commitment or instrument to which it
is a Party (and the execution, delivery and performance of this Agreement
by the Party does not require the consent, approval or authorisation of,
or notice, declaration, filing or registration with, any governmental or
regulatory authority).
16.02 CAT represents to HGS that to the best of its belief as of the Effective
Date the CAT Antibody Patents are the main patents required from CAT
to operate CAT's antibody phage display technology.
ARTICLE 17 NOTICES
17.01 All notices or other communications required or permitted to be given by
either party under this Agreement shall be in writing and shall,
unless otherwise specifically set forth herein, be sufficiently given
by either party when deposited in the mail, registered or certified,
postage prepaid, or by telefacsimile, and addressed as hereinafter set
forth or to such other addressee and/or address as or shall
subsequently be designated by either party by notice given in
accordance with this Section.
To HGS:
Human Genome Sciences
▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
Attn: General Counsel
Fax (▇) ▇▇▇ ▇▇▇ ▇▇▇▇
To CAT:
Cambridge Antibody Technology Ltd.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
Attn: Company Secretary
Fax: (▇▇) ▇▇▇▇ ▇▇▇▇▇▇
17.02 Either party may change the address or the recipient to which notice is to
be provided by written notice pursuant to this Clause.
ARTICLE 18 TERM AND TERMINATION
18.01 Unless and until earlier terminated as provided in this Article this
Agreement shall commence on the Effective Date and shall continue
until the last to expire of the patents in the CAT Background IP which
patents would be infringed by a Licensed Product or the expiry of ten
years from the date of First Commercial Sale of a Licensed Product by
HGS or its Affiliates or sublicensees (whichever is the later).
18.02 If either party breaches or defaults in the performance or observance of
any of its material obligations under this Agreement, and such breach
or default is not cured within 30 days after receipt by such party of
a written notice from the non-breaching party specifying the breach or
default (or such longer period as is reasonably necessary if the
breach is of such a nature that it cannot be reasonably cured within
30 days) then the non-breaching party shall have the right to
terminate this Agreement.
18.03 If CAT has failed to provide to HGS a Clinical Development Antibody, HGS
may terminate this agreement upon written notice to CAT. If HGS has
failed to provide an animal model for the In-Vivo Proof of Concept
within [***] in respect of Target 1 and within the time period as
agreed by the JMC in respect of Target 2 and 3 or has failed to
indicate a Clinical Indication within [***] of the Effective Date in
respect of Target 1 and within the time period agreed by the JMC in
respect of Target 2 and 3 then CAT may terminate this Agreement upon
written notice to HGS provided that termination based on Target 2 or
Target 3 shall be effective only with respect to that Target.
18.04 Either party may terminate this Agreement by written notice to the other
party in the event the other party shall have become subject to an
Insolvency Event.
18.05 No exercise by CAT or HGS of any right of termination shall constitute a
waiver of any right of CAT or HGS for recovery of any monies then due
to it hereunder or any other right or remedy may have at law, in
equity or under this Agreement.
ARTICLE 19 CONSEQUENCES OF TERMINATION
19.01 The provisions of Articles 5 8 9 10 12 and 14 shall survive the
termination for any reason of this Agreement.
19.02 In addition the obligation to make payments under this Agreement with
respect to any
period prior to its termination shall survive the termination of this
Agreement. Termination of this Agreement is to be without prejudice to
rights of either party which have accrued and are due prior to
termination.
ARTICLE 20 ADDITIONAL PROGRAMMES & AREAS OF EXCLUSIVITY
20.01 CAT agrees to conduct additional Research Programmes directed to 2
further Targets in addition to the Target on behalf of HGS on the
terms specified in this Agreement, adding the new Target(s) to the
definition of the Antigen in Clause 1.04 and throughout this
Agreement, and defining a Research Programme for each such Target 2
and Target 3 pursuant to Article 2, with the following limitations:
(a) The JMC shall agree that Target 2 and Target 3 is suitable to enter a
Research Programme. In reaching such a determination the JMC shall give
weight to the fact that any new Target shall meet similar criteria to the
Antigen in terms of availability of the Antigen and relevant assay,
supporting background biology and empirical support for an antibody based
therapeutic intervention. In addition the JMC shall be satisfied that the
Time Line is appropriate and that CAT is aware of any competing
technologies that HGS has initiated or is considering initiating in
respect of any new Target.
(b) CAT shall have the right to reject a proposed Target 2 or 3 within
[***] of the date of said proposal if:
[***]
In the case of any Target rejected by CAT, HGS shall have a right but not
an obligation to propose a substitute Target.
20.02 CAT shall use reasonable endeavours to commence a Research Programme
promptly after agreement of the JMC to accept a Target.
20.03 HGS's right to initiate any subsequent Research Programme hereunder shall
terminate [***] from the Effective Date.
20.04 Royalty payments, milestone payments and other terms for Target 2 and
Target 3 will be as specified herein except that the set of milestone
payments with respect to Target 2 and Target 3 shall be increased from
the milestone payments specified herein for the Target by [***] for
each subsequent twelve month period between the Effective Date and the
initiation of the Research Programme directed to such subsequent
Target.
ARTICLE 21 FORCE MAJEURE
21.01 Each of the parties hereto shall be excused from the performance of its
obligations
(except the obligations of confidentiality and non-disclosure
imposed in Article 10 above) hereunder in the event such
performance is prevented by force majeure. For the purpose of this
Agreement, force majeure is defined as follows:
a) Strikes, lockouts, or other industrial action taken by the employees
of any party or any third party (whether or not the party against whom
such action is taken could have avoided the same by acceding to the
demands of the employees responsible for such action);
b) Civil commotion, embargo, governmental legislation or regulation,
riot, invasion, war, threat of or preparation of war;
c) Fire, explosion, storm, flood, earthquake, subsidence, epidemic or
other natural physical disaster.
If the period of force majeure extends beyond six months then this
Agreement may be terminated by either party upon written notice.
ARTICLE 22 WAIVER AND ASSIGNMENT
22.01 The right of either party at any time to require strict performance by
the other party hereto of all the terms and conditions hereof shall
not in any way be affected or impaired by prior waiver, forbearance or
course of dealing.
22.02 This Agreement shall not be assigned by either party without the prior
written consent of the other party, such consent not to be
unreasonably withheld, provided however that a party may assign this
Agreement or any of its rights or obligations hereunder to any
affiliate or to any third party with which it may merge or consolidate
or to which it may transfer all or substantially all of its assets to
which this agreement relates, without obtaining the consent of the
other party, provided that the assigning party remains liable under
this agreement and that the third party, assignee or surviving entity
assumes in writing all of its obligations under this agreement.
22.03 This Agreement shall be binding upon any permitted assignee of either
party.
ARTICLE 23 ANNOUNCEMENTS
23.01 Subject to Clause 23.02 no press release announcement or other
communication to any third party concerning the transaction
contemplated by this Agreement or the financial terms of this
Agreement or any ancillary matters shall be made or permitted or
authorised to be made by either Party without the prior written
approval of the other, such approval not to be unreasonably withheld
or delayed.
23.02 Either Party may make an announcement concerning the transactions
contemplated by this Agreement or any ancillary matter if required by:
(a) law or regulation
(b) existing contractual obligations; or
(c) any Securities Exchange or Regulatory Authority or governmental body
to which either party is subject or submits, wherever situated,
including (without limitation) the US Securities Exchange Commission,
The UK Stock Exchange or The Panel on Take-overs and Mergers, whether
or not the requirement has the force of law
ARTICLE 24 MISCELLANEOUS
24.01 If any provision of this Agreement is held by a court of competent
jurisdiction to be invalid or unenforceable, it shall be modified, if
possible, to the minimum extent necessary to make it valid and
enforceable or, if such modification is not possible, it shall be
stricken and the remaining provisions shall remain in full force and
effect; provided, however, that if a provision is stricken as to
materially affect the economic benefits of this Agreement, the party
adversely affected may terminate this Agreement upon sixty days prior
written notice to the other party.
24.02 The headings set forth at the beginning of the various Articles and
Sections of this Agreement are for reference and convenience and shall
not affect the meanings of the provisions of this Agreement.
24.03 If so advised the parties shall co-operate in notification of this
Agreement to the Commission of the European Community pursuant to
Council Regulation 17/62 of the Council of Ministers of the European
Community as soon as reasonably practicable after the Commencement
Date. Each Party shall be responsible for its own costs and expenses
related to such notification. Each Party will give the other full and
prompt co-operation in providing any information which the other may
require in order to prepare such notification.
24.04 Nothing herein shall be deemed to establish a relationship of principal
and agent between CAT and HGS, not any of their agents or employees
for any purpose whatsoever. This Agreement shall not be construed as
constituting CAT and HGS as partners, or as creating any other form of
legal association or arrangement with could impose liability upon one
party for the act or failure to act of the other party.
24.05 Nothing contained in this Agreement shall be construed as conferring any
right to use in advertising, or other promotional activities, any
name, trade name, trademark, or
other designation of either party thereto.
24.06 This Agreement may be executed in multiple counterparts, each of which
shall be deemed an original and which together shall constitute one
and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized officers as of the Effective Date.
Human Genome Sciences, Inc.
By:_________________________________________________
Title:______________________________________________
Cambridge Antibody Technology Ltd.
By:_________________________________________________
Title:______________________________________________
EXHIBIT A
In the course of the Research Programme pertaining to the Target, the Parties
shall have the following obligations as modified from time to time by agreement
of the JMC.
Human Genome Sciences
[***]
Cambridge Antibody Technology
[***]
EXHIBIT B
EXISTING CAT THIRD PARTY ROYALTY OBLIGATIONS
1. License Agreement, dated January 7, 1997, between CAT and MRC, with certain
royalty rates, as may be amended from time to time which shall include all
royalty payments due to The Scripps Research Institute and Stratagene
pursuant to an agreement dated 25 June 1999 (the "MRC License").
2. Therapeutic Antibodies Agreement, dated December 31, 1997, between CAT and
Dyax Corp., with a royalty rate of [***], as may be amended from time to
time (the "Dyax License").
3. Diagnostic Antibodies Agreement, dated December 31, 1997, between CAT and
Dyax Corp., with a royalty rate of [***], as may be amended from time to
time (the "Dyax License").
1/ [***] indicates that text has been deleted, which is subject to a
confidential treatment request. This text has been filed with the SEC on a
supplemental basis.