Exhibit 10.35


 


CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH “***”


 


 


COLLABORATION
AND LICENCE AGREEMENT


 


 


DATED 15
AUGUST 2005


 


 


AMONG


 


UCB S.A.


 


AND


 


IMCLONE
SYSTEMS INCORPORATED


 





















 


CONTENTS


 


 


	
  Article

  	
   

  	
   

  
	
   

  	
   

  
	
  1.

  	
  Definitions

  	
   

  
	
  2.

  	
  Scope of Collaboration

  	
   

  
	
  3.

  	
  Collaboration Management

  	
   

  
	
  4.

  	
  Development of Antibody
  Products

  	
   

  
	
  5.

  	
  Regulatory Affairs

  	
   

  
	
  6.

  	
  Commercialisation
  of Antibody Products

  	
   

  
	
  7.

  	
  Manufacture and
  Supply

  	
   

  
	
  8.

  	
  INDEPENDENT
  IndicationS

  	
   

  
	
  9.

  	
  Grant of Rights

  	
   

  
	
  10.

  	
  Rights in
  Intellectual Property

  	
   

  
	
  11.

  	
  Confidentiality
  and Non-Use

  	
   

  
	
  12.

  	
  Term and Termination

  	
   

  
	
  13.

  	
  Representations,
  Warranties and Covenants

  	
   

  
	
  14.

  	
  Indemnification
  and Insurance

  	
   

  
	
  15.

  	
  Dispute Resolution

  	
   

  
	
  16.

  	
  Imclone
  Option; Competing Products

  	
   

  
	
  17.

  	
  Miscellaneous

  	
   

  
	
  Schedule 1:

  	
  Patent Rights And Trademarks

  	
   

  
	
  Schedule 2:

  	
  Financial Planning, Accounting and
  Reporting

  	
   

  
	
  Schedule 3:

  	
  Development Plan

  	
   

  
	
  Schedule 4:

  	
  Existing Supply Agreements

  	
   

  
					



 





















 


COLLABORATION
AND LICENCE AGREEMENT


 


THIS COLLABORATION AND LICENCE
AGREEMENT (this Agreement)
is entered into on 15 August 2005 (the Effective
Date)


 


BETWEEN:


 


(1)                                  UCB, S.A., a Belgian company (Company No. 0403 053 608) of
Allée de la Recherche, 60, 1070 Brussels, Belgium, 1070 (UCB); and


 


(2)                                  IMCLONE SYSTEMS INCORPORATED, a Delaware corporation, of 180 Varick Street,
6th Floor, New York, NY 10014, USA (ImClone).


 


RECITALS:


 


(A)                              UCB and
ImClone have identified antibodies that bind to, and are directed against, KDR
as having potential value in oncology and each of them has experience and
expertise in the development of antibody-based pharmaceuticals.


 


(B)                                The
Parties believe that entering into this Agreement is in their mutual interest
and in the interest of the public, and that collaboration under the terms of
this Agreement will improve the prospects of success of the approval and delivery
of Antibody Products, will lead to effective and efficient Development,
Manufacturing and Commercialisation of Antibody Products and will be an
efficient and cost effective way of promoting Antibody Products to the benefit
of consumers.


 


(C)                                UCB and
ImClone each wishes to grant to the other certain licences under each Party’s
respective intellectual property rights to permit the other Party to
participate in mutually beneficial collaborative Development, Manufacturing and
Commercialisation of Antibody Products.


 


NOW THEREFORE, in
consideration of the foregoing premises and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
UCB and ImClone, intending to be legally bound, do hereby agree as follows:


 


1.                                      DEFINITIONS


 


1.1                               When
used in this Agreement, each of the following terms shall have the meanings set
out in this Article 1.1:


 


1121B means an
Antibody as disclosed in PCT Application PCT\US03\06459.


 


Adversarial
Prosecution Action means (i) with respect to any Patent Rights,
any patent interferences, re-examinations, reissues, revocations, observations
or oppositions lodged against such Patent Rights; and (ii) with respect to any
Trademark, any trademark interferences, observations, oppositions, rectifications,
revocations or invalidations lodged against such Trademark.


 


Affiliate means any
corporation, company, partnership, joint venture or other entity which
controls, is controlled by, or is under common control with a Party.  For


 


3





















 


purposes of this definition and the definition
of “Change of Control” only, control shall be presumed to exist if one of the
following conditions is met: (a) in the case of corporate entities, direct or
indirect ownership of at least fifty per cent. (50%) of the stock or shares
having the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty per
cent. (50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities. 
The Parties acknowledge that in the case of certain entities organised
under the laws of certain countries, the maximum percentage ownership permitted
by law for a foreign investor may be less than fifty per cent. (50%), and that
in such case such lower percentage shall be substituted in the preceding
sentence, provided that such
foreign investor has the power to direct the management and policies of such
entity.


 


Agreed
Indications means the oncology Indications set forth in the
outline for the Development Plan and thereafter the Development Plan and such
other oncology Indications as are recommended by the Parties pursuant to
Article 4.7 and approved by the Collaboration Committee pursuant to Article
3.3(a).  Agreed Indications shall include
any Converted Agreed Indication.


 


Antibody means any
antibody [***]  
[Confidential Treatment Required]


 


Antibody
Product means (i) a pharmaceutical product that includes
CDP-791 as the sole active ingredient, and (ii) any other pharmaceutical
product containing CDP-791 or another Antibody that binds to, and is directed
against, KDR (including a Competing Product) that is agreed between the Parties
in accordance with Article 2.1(b) or 16.5.


 


Applicable
Law means the applicable laws, rules and regulations
(including any rules, regulations, guidelines or other requirements of the
Regulatory Authorities, including GMP, GLP and GCP) that may be in effect from
time to time in the Territory, to the extent applicable.


 


Business
Day means a day other than a Saturday or Sunday on which
banking institutions in both New York, New York USA and London, England are
open for business.


 


Calendar
Quarter means each of the three (3) month periods beginning
1st January, 1st April, 1st July and 1st October, provided that the first Calendar Quarter during the Term
shall commence on the Effective Date and end on 30th September, 2005 and Quarterly shall have a corresponding
meaning.


 


CDP-791 means the
Antibody as disclosed in the IMPD EudraCT number 2005-00173130 filed by
Celltech R&D Limited.


 


Change of
Control means, with respect to a Party, a change of the
entity that has control (directly or indirectly) of that Party.  For the purposes of this definition, control
shall have the meaning given to it in the definition of “Affiliate”.


 


Clinical
Study means (i) a human clinical study in any country that
is intended to initially evaluate the safety or pharmacological effect of an
Antibody Product in subjects or that would otherwise satisfy requirements of 21
C.F.R. 312.21(a), or its


 


4





















 


equivalent outside the United States (a Phase I Clinical Study), (ii) a human
clinical study in any country that is intended to initially evaluate the
effectiveness of an Antibody Product for a particular indication or indications
in patients with the disease or indication under study or that would otherwise
satisfy requirements of 21 C.F.R. 312.21(b), or its equivalent outside the
United States (a Phase II Clinical Study),
(iii) a pivotal human clinical study, the principal purpose of which is to
establish safety and efficacy in patients with the disease target being studied
as required in 21 C.F.R. 312, or similar clinical studies prescribed by the
Regulatory Authorities in a country other than the United States whether or not
such study is a traditional Phase III study (a Phase III Clinical Study) or (iv) a human clinical study that
is required or requested by a Regulatory Authority as a condition of or in
connection with obtaining or maintaining a Regulatory Approval (whether
commenced prior to or after receipt of such Regulatory Approval) (a Phase IV Clinical Study).  A Clinical Study shall be deemed to be
complete on the date specified by the JDT in accordance with Article 4.6(b)(v).


 


Clinical
Supplies means supplies of ICH and GMP compliant Antibody
Products in suitable form for use in Development or Post-Approval Studies.


 


Collaboration
Committee means the committee formed pursuant to Article 3.1.


 


Commercial
Supplies means supplies of Antibody Products in suitable final
packaged form, in accordance with a specification agreed by the Parties,
Manufactured in compliance with GMP, and ready to be offered for commercial
sale for use in the Field in the Territory by ImClone, UCB, their Affiliates,
sublicensees and Distributors (or any of them).


 


Commercialisation or Commercialise means any and all activities
(whether before or after Regulatory Approval) directed to marketing, Detailing
and Promotion (or any of those activities) of an Antibody Product for
commercial sale, and shall include Post-Approval Studies, pre-launch and
post-launch marketing, Promoting, Detailing, distributing, offering to sell and
selling an Antibody Product, importing, exporting or transporting an Antibody
Product for sale, and interacting with Regulatory Authorities regarding the
foregoing, but shall exclude Manufacturing. 
When used as a verb, Commercialising
means to engage in Commercialisation and Commercialised
shall have a corresponding meaning.


 


Commercialisation
Plan means the comprehensive plan and overall strategy for
the Commercialisation of Antibody Products, to be prepared, updated and amended
pursuant to Article 6.5.


 


Commercially
Reasonable and  Diligent Efforts means efforts and
resources commonly associated with good business practice and standards in the
research-based pharmaceutical industry to research, develop, manufacture or
commercialise (as appropriate) a product or compound of similar market
potential at a similar stage in its product life, taking into account safety,
efficacy, the competitiveness of alternative products and product candidates in
the marketplace, the patent and other proprietary position of the product, the
likelihood of Regulatory Approval given the regulatory structure involved, the
profitability of the product including the royalties payable to licensors of
Patent Rights, alternative products and product candidates and other reasonably
relevant factors.  Commercially Reasonable
and Diligent Efforts where


 


5





















 


appropriate shall be determined on a
market-by-market basis for a particular product, and the level of effort may
change over time, reflecting changes in the status of the product and the
market involved.


 


Committee means any
of the Collaboration Committee, JDT, JCT, JMT, JPC or any sub-team or
sub-committee thereof established pursuant to this Agreement, as the case may
be.


 


Compendia
Listing means a listing for an indication in the United
States for a Product that is supported by a citation in at least one of the
following authoritative drug reference books: (a) the American Society of
Health-System Pharmacists’ American Hospital Formulary Service (AHFS), or (b)
the U.S. Pharmacopoeia Drug Information, or in another similar authoritative
drug reference book that is relied on by Third Party payors in authorizing
reimbursement for such Product for such indication.


 


Competing
Product [***]
  [Confidential Treatment Required]


 


Confidential
Information means all Information and all Materials provided by a
Party or its Affiliates to the other Party or its Affiliates either in
connection with the discussions or negotiations pertaining to, or in the course
of performing, this Agreement, including all Information and Materials
developed during the course of Development, Commercialisation or Manufacture of
Antibody Products under this Agreement and all Information of a Party disclosed
at any meeting of any Committee or disclosed through a report to or from any
such Committee.  The terms of this
Agreement and the Joint Know-How shall be considered Confidential Information
of each Party.


 


Contract
Year means: (a) with respect to the first Contract Year,
the period beginning on the Effective Date and ending on 31st December, 2005
(the First Contract Year); and (b)
with respect to each subsequent Contract Year, the twelve (12) month period
beginning on the day following the end of the First Contract Year and each
succeeding twelve (12) month period.


 


Control or Controlled means, with respect to any (a)
Materials or Information, or (b) intellectual property or proprietary right, in
each case the possession (whether by ownership, licence or other right, other
than pursuant to this Agreement) by a Party or its Affiliates of the ability to
grant to the other Party access and/or a licence (or sublicence) as provided in
this Agreement under such right or to such Material or Information [***]   [Confidential Treatment
Required].


 


Co-Promotion
and Co-Promote mean, with respect to an Antibody Product,
those activities and obligations including Detailing undertaken by a Third
Party in collaboration with a Party to encourage sales of such Antibody Product
by that Party, but not including Promotion or other activities conducted by
Affiliates or sublicensees in connection with sales on their own account or
Distributors or Third Parties (including contract sales organisations and
advertising agencies) appointed on a subcontract basis to perform services for
the Party.


 


Core Patent
Rights means the ImClone Core Patent Rights or the UCB Core
Patent Rights.


 


6





















 


Corporate
Marks means the ImClone Company Marks and UCB Company Marks.


 


Data
Package means, with respect to an Antibody Product for an
Independent Indication or a Competing Product (a) for which a Drug Approval
Application has not been approved by the Regulatory Authorities in the United
States, including the FDA, or Europe, including the EMEA, (i) a summary of all
the relevant clinical data with respect to the Independent Indication for the
Antibody Product or to the Competing Product, as applicable, including any
Clinical Study results and resultant data analyses, (ii) any regulatory
submissions made to the FDA or any other Regulatory Authority by or on behalf
of the Continuing Party with respect to such Independent Indication for such
Antibody Product or to such Competing Product, (iii) protocols for any ongoing
Clinical Studies and proposed designs for any anticipated Clinical Studies with
respect to such Independent Indication for such Antibody Product or to such
Competing Product, (iv) a budget for the costs and expenses expected to be
incurred in connection with any ongoing Development of such Independent
Indication for such Antibody Product or Competing Product and, (v) such other
material Information and Materials relating to such Independent Indication for
such Antibody Product or to such Competing Product in the control of the
Continuing Party that were not previously disclosed to the Non-Continuing Party
and that were relied on by the Continuing Party’s senior management in
determining to proceed with the current phase of Development of such
Independent Indication for such Antibody Product or of such Competing Product,
and (b) for which a Drug Approval Application has been approved by the
Regulatory Authorities in the United States, including the FDA, or Europe,
including the EMEA, a copy of such Drug Approval Application and any other
filings made with the Regulatory Authorities with respect to the Antibody
Product for such Independent Indication or the Competing Product.


 


Detail means an
interactive face-to-face contact (including a live video presentation) of a
sales representative, who is adequately equipped with, and knowledgeable of,
applicable Promotional Materials and Product Labelling, with a physician or
other medical professional licensed to prescribe drugs or other healthcare
professional that has a significant impact or influence on prescribing
decisions including: (a) a medical professional with prescribing authority; or
(b) to the extent permitted by Applicable Law, an office nurse with influence
over the pharmaceutical treatment of a patient, in which relevant
characteristics of the applicable Antibody Product are described by the sales
representative in a fair and balanced manner consistent with the requirements
of this Agreement and Applicable Law, and in a manner that is customary in the
industry for the purpose of promoting a prescription pharmaceutical
product.  When used as a verb, Detail
means to engage in a Detail.  A sample
drop does not constitute a Detail.


 


Development or Develop means all activities related to
research, preclinical and other non-clinical testing, test method development
and stability testing, toxicology, Clinical Studies other than Post-Approval
Studies, regulatory affairs, statistical analysis and report writing, market
research and development, the preparation and submission of Drug Approval
Applications and all other activities [***]   [Confidential Treatment Required] or otherwise
requested or required by a Regulatory Authority as a condition or in support of
obtaining or maintaining a Regulatory Approval for an Antibody Product for a
specified Indication, but excluding Manufacturing.


 


7





















 


Development
Plan means the plan for the Development of Antibody
Products for Agreed Indications.  An
outline for the Development Plan is attached as Schedule 3 and the Development
Plan shall be adopted and subsequently updated and amended pursuant to Article
4.7.  For clarity, the outline for the
Development Plan attached as Schedule 3 shall not constitute the Development
Plan for the purposes of this Agreement.


 


Distributor means a
person or entity, other than a sublicensee, in a country that (a) purchases an
Antibody Product from the Territorial Lead, its Affiliate or a permitted
sublicensee for that country; (b) assumes responsibility from the Territorial
Lead for all or a portion of the Promotion, marketing, sales and customer
service effort related to such Antibody Product in such country; and (c) sells
Antibody Product in such country.


 


Dollar means a
United States dollar, and $ shall be interpreted accordingly.


 


Drug
Approval Application means an application for any Regulatory
Approval required before commercial sale or marketing of a pharmaceutical or
biopharmaceutical product as a drug or to treat a particular Indication,
including: (a) (i) a Biologics Licence Application (BLA) submitted to the FDA and (ii) any counterpart of a U.S.
BLA in any other country in the Territory; and (b) all supplements and
amendments that may be filed with respect to the foregoing.


 


EMEA means the
European Medicines Agency or a successor agency.


 


Enforcement
Action means (a) the enforcement of a Patent Right or
Trademark, (b) the defence of a validity or enforceability challenge to a
Patent Right or Trademark, including the defence of an action for a declaratory
judgment of, or counterclaim asserting, non-infringement, invalidity,
unenforceability of a Patent Right or 

non-infringement, invalidity, unenforceability or dilution of a Trademark, as
applicable, or (c) a dispute pertaining to the inventorship of a Patent Right
or ownership of a Trademark.


 


EU means the
economic, scientific and political organization of member states, as it may be
expanded from time to time.


 


Europe means the
countries comprising the EU and also includes Norway, Iceland, Lichtenstein and
Switzerland.


 


FDA means the
United States Food and Drug Administration or a successor agency.


 


FFDCA means the
United States Federal Food, Drug, and Cosmetic Act, as amended from time to
time.


 


Field means the
[***]   [Confidential
Treatment Required].


 


First
Commercial Sale means the first shipment of any Antibody
Product sold to a Third Party by a Party or its Affiliates or their respective
Distributors or sublicensees in a country in the Territory.  First Commercial Sale shall be determined on
a country by country basis.


 


8





















 


Force
Majeure means any occurrence beyond the reasonable control of
a Party that prevents or substantially interferes with the performance by a
Party of any of its obligations under this Agreement, including fires, floods,
earthquakes, embargoes, shortages, epidemics, quarantines, war, acts of war
(whether war be declared or not), acts of terrorism, insurrections, riots,
civil commotion, acts of God or unforeseen acts, omissions or delays in acting
by any governmental authority.  For clarity,
any failure to perform by a sublicensee, Distributor or sub-contractor of a
Party shall not be deemed a Force Majeure for such Party unless the reason for
such failure is an occurrence beyond the reasonable control of such
sublicensee, Distributor or sub-contractor (as appropriate) that prevents or
substantially interferes with the performance of the tasks that have been
delegated to such sublicensee, Distributor or sub-contractor by that Party
pursuant to this Agreement.


 


HSR Act means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended from time to time, and the rules and regulations promulgated
thereunder.


 


HSR Filing means any filing by UCB or ImClone with the United States Federal
Trade Commission and the Antitrust Division of the United States Department of
Justice of a Notification and Report Form for Certain Mergers and Acquisitions
(as that term is defined in the HSR Act) with respect to the matters set forth
in this Agreement, together with all required documentary attachments thereto.


 


GAAP means
United States generally accepted accounting principles consistently applied.


 


GCP or Good Clinical Practice means the
then-current standards for clinical trials for pharmaceuticals as are required
by the Regulatory Authorities in Europe, the United States and Japan and other
organisations and governmental agencies in countries in which any Antibody
Product is intended to be sold or tested, to the extent such standards are not
less stringent than standards of good clinical practice in Europe, the United
States and Japan, provided that a
Party shall not be held to any standards of good clinical practice that are
more onerous than those standards required by Applicable Law and the Regulatory
Authorities in the countries in which it is the Territorial Lead and, to the
extent not included in such countries, Europe, the United States and Japan,
unless such standards have been specifically identified and approved for
implementation by the JDT.


 


GLP means the
then-current standards for laboratory activities for pharmaceuticals, as are
required by the Regulatory Authorities of Europe, the United States and Japan,
including 21 C.F.R. part 58 and EC Directives 87/18/EEC, 88/320/EEC and
1999/11/EC, in each case, as amended from time to time.


 


GMP or cGMP means the then-current standards for
good Manufacturing practices as are required by the Regulatory Authorities in
Europe, the United States and Japan and other organisations and governmental
agencies in countries in which any Antibody Product is intended to be
Manufactured or sold, to the extent such standards are not less stringent than
standards of good Manufacturing practice in Europe, the United States and
Japan.


 


ICH means the
International Conference on Harmonisation.


 


9





















 


ImClone
Company Marks means the Trademarks Controlled by ImClone or its
Affiliates, whether on the Effective Date or during the Term, that are
designated by ImClone pursuant to Article 6.12(b) for use on or in connection
with the Development and Commercialisation of an Antibody Product under the
Agreement.


 


ImClone
Core Patent Rights means those ImClone Patent Rights identified
as such in Part 4 of Schedule 1.


 


ImClone
In-Licences means the licences listed in Part 2 of Schedule 1, as
may be amended from time to time, each one an ImClone In-Licence.


 


ImClone
Know-How means any and all Information and Materials that are
Controlled by ImClone or any of its Affiliates at any time [***]   [Confidential Treatment
Required]; provided, however, that any Information and
Materials acquired by ImClone or any of its Affiliates after the Effective
Date, whether by licence, merger, acquisition or otherwise, [***]   [Confidential Treatment
Required].  ImClone Know-How excludes (i)
any Information and Materials included in the Joint Know-How; (ii) any
Information and Materials expressly excluded from this definition pursuant to
Article 10.8(b);  (iii) the ImClone
Patent Rights; and (iv) Joint Patent Rights.


 


ImClone
Patent Rights means any and all Patent Rights that are Controlled
by ImClone or any of its Affiliates, in each case which if not licensed in this
Agreement would be infringed by Developing, Commercialising, making, having
made, using, selling, having sold, offering to sell or resell, importing,
exporting, distributing or otherwise transferring physical possession of or
otherwise transferring title in or to an Antibody Product in the Field,
including any Patent Rights which claim ImClone Know-How; provided, however,
that any Patent Rights that are acquired by ImClone or any of its Affiliates
after the Effective Date, whether by licence, merger, acquisition or otherwise,
[***]   [Confidential
Treatment Required].  ImClone Patent
Rights excludes the Joint Patent Rights and those Patent Rights expressly
excluded from this definition pursuant to Article 10.8(b).  As of the Effective Date, ImClone Patent
Rights include those Patent Rights set out in Part 4 of Schedule 1.


 


ImClone
Territory means the United States, Canada and Mexico, and each
of their respective territories and possessions.


 


IND means (a)
(i) an Investigational New Drug Application (as defined in the FFDCA and the
regulations promulgated thereunder, including 21 C.F.R. part 312) that is
required to be filed with the FDA before beginning clinical testing of an
Antibody Product in human subjects, or any successor application or procedure;
and (ii) any counterpart of a U.S. Investigational New Drug Application in any
other country in the Territory; and (b) all supplements and amendments that may
be filed with respect to the foregoing.


 


Indication means a
specific line of therapy (i.e. first, second, third or other) for the cancer
sub-type(s) as set forth in a protocol of a particular Phase II Clinical Study,
Phase III Clinical Study or Phase IV Clinical Study (or, where no cancer
sub-type is referenced in such protocol, a specific line of therapy for the
cancer type set forth in such protocol).


 


10





















 


Information means
tangible or intangible know-how, trade secrets, inventions (that are conceived
and reduced to practice, constructively or actually), methods, knowledge,
conclusions, skill, experience, test data and results (including chemical,
biological, biochemical, pharmaceutical, pharmacological, toxicological and
research, pre-clinical and other non-clinical data, clinical data, assay,
control and manufacturing processes, test data and results), analytical and
quality control methods and data, results or descriptions, software and
algorithms or other information (in each case, whether or not patentable)
regarding technology, techniques, practices, products, protocols, procedures,
business information or objectives.


 


In-Licences means the
ImClone In-Licences and the UCB In-Licences collectively.


 


Joint
Commercialisation Team or JCT
means the team formed pursuant to Article 6.3.


 


Joint
Development Team or JDT
means the team formed pursuant to Article 4.6.


 


Joint
Know-How means all Information conceived, developed,
discovered, generated or otherwise made and all Materials characterised,
conceived, developed, derived, generated or otherwise made, in either case (a)
jointly by employees or consultants of UCB or its Affiliates or, to the extent
UCB or its Affiliates has rights thereto, their respective sublicensees and
Distributors, on the one hand, and ImClone or its Affiliates, or, to the extent
ImClone or its Affiliates has rights thereto, their respective sublicensees and
Distributors, on the other hand (rather than independently by the employees or
consultants of one or the other Party or its Affiliates, sublicensees or
Distributors) in the course of Development, Commercialisation or Manufacturing
of an Antibody Product under or in connection with, and during the Term of,
this Agreement or (b) [***]
  [Confidential Treatment Required].


 


Joint
Manufacturing Team or JMT
means the committee formed pursuant to Article 7.1.


 


Joint
Patent Committee or JPC
means the committee formed pursuant to Article 3.4.


 


Joint
Patent Rights means Patent Rights in any country within the
Territory which claim Joint Know-How.


 


KDR means
kinase domain receptor, also known in the literature as VEGFR2 or kinase insert
domain receptor.


 


Knowledge means,
with respect to a Party, the good faith understanding of the facts and information
in the possession of an officer of such Party or any of its Affiliates, or any
in-house legal counsel of, or in-house patent agents employed by, such Party or
any of its Affiliates, without any duty to conduct any additional investigation
with respect to such facts and information by reason of the execution of this
Agreement.  For purposes of this
definition, an “officer” shall mean any person in the position of vice
president, senior vice president, president or chief executive officer, or any
person having similar responsibilities, of a Party or any of its Affiliates.


 


11





















 


Manufacturing or Manufacture means all activities related to
the production, manufacture, processing, filling, finishing, packaging,
labelling, shipping, and storage of Antibody Products, including process
development, process qualification and process validation, manufacturing
scale-up, pre-clinical, clinical and commercial manufacture and analytical
development, product characterisation, quality assurance and quality control.


 


Materials means
biological and chemical materials, including Antibodies (other than Antibody
Products), screens, animal models, cell lines, cells, vectors, nucleic acids,
and reagents, and any progeny or derivatives thereof.


 


Non-Remaining
Party means, on termination of this Agreement, the Party
designated as the Non-Remaining Party under Article 12.2, 12.3(a), 12.4(d),
12.5(b) or 12.6 (as appropriate).


 


Party means UCB
or ImClone; Parties means UCB and
ImClone.


 


Patent
Rights means, in any country, all: (a) existing issued,
unexpired patents (with the term patent being deemed to encompass an inventor’s
certificate, utility model, petty patent and design patent), including any
reissue, re-examination, renewal or extension (including any supplementary
protection certificate) of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such patent, in such
country; (b) existing patent applications and patent applications filed after
the date of this Agreement, including any request for continued examination
(RCE), continuations, continuations-in-part, divisionals, provisionals,
converted provisional, continued prosecution application, or any substitute
applications, any patent issued with respect to any such patent applications,
any reissue, re-examination, renewal or extension (including any supplementary
protection certificate) of any such patent and any confirmation patent or
registration patent or patent of addition based on any such patent in such
country; and (c) all foreign counterparts of any of the foregoing.


 


Post-Approval
Study means any human clinical study, or other test or
study, other than a Clinical Study, with respect to an Antibody Product for an
Agreed Indication or an Independent Indication that (a) is conducted solely in
support of pricing or reimbursement for a product in a country or (b) is not
required to obtain or maintain Regulatory Approval for such Antibody Product
for such Agreed Indication or Independent Indication and is conducted (i)
within the scope of the Product Labelling for such Antibody Product or (ii)
outside the scope of such Product Labelling in support of a Compendia Listing
(for clarity, any human clinical study that is intended to expand the Product
Labelling for an Antibody Product (except as provided in paragraph (ii) above)
shall be a Clinical Study and shall be governed by the procedures set forth in
Article 4.9 with respect to new Indications). 
Subject to the foregoing, Post-Approval Studies may include
epidemiological studies, modeling and pharmacoeconomic studies, post-marketing
surveillance studies, investigator sponsored studies, and health economics
studies.


 


[***]
  [Confidential Treatment Required]


 


Product
Labelling means, with respect to an Antibody Product, for any
country of the Territory (a) the Regulatory Authority-approved full prescribing
information for


 


12





















 


such Antibody Product for that country,
including any required patient information; and (b) all labels and other
written, printed or graphic matter upon a container, wrapper or any package
insert utilised with or for such Antibody Product.


 


Product
Trademark means any Trademark that is identified by the Parties
and approved by the Collaboration Committee pursuant to Article 3.2(d) for use
in Commercialising the Antibody Products in the Territory, but not including
any Corporate Marks.


 


Promote,
Promotion, Promoting or Promotional
means, with respect to an Antibody Product, those activities and obligations
other than Detailing undertaken by a Party, its Affiliates, sublicensees or
Distributors to encourage sales of such Antibody Product, including journal
advertising, direct mail programmes, direct-to-consumer advertising, Internet
advertising, broadcast advertising, distributing sales reminders (e.g., scratch
pads, pens and other such items), convention exhibits, and other forms of
advertising and promotion.


 


Promotional
Materials means all sales representative training materials
with respect to an Antibody Product and all written, printed, graphic,
electronic, audio or video matter, including journal advertisements, sales
visual aids, direct mail, direct-to-consumer advertising, Internet postings,
broadcast advertisements, and sales reminder aids (e.g., scratch pads, pens and
other such items) intended for use or used by a Party, its Affiliates,
sublicensees and Distributors in connection with any Promotion or Detailing of
an Antibody Product, except Product Labelling.


 


Regulatory
Approval means any and all approvals (including any applicable
supplements, amendments, pre- and post-approvals, governmental price and
reimbursement approvals and approvals of applications for regulatory
exclusivity), licences, registrations, or authorisations of any federal,
national, multinational, international, state, provincial or local regulatory
agency, department, bureau, commission, council or other governmental entity
necessary for the Manufacture, distribution or other transfer of possession,
use, holding, storage, import, export, transport, Promotion, marketing or sale
of an Antibody Product in a country or jurisdiction in the Territory.  For clarity, a Compendia Listing shall not be
deemed to be a Regulatory Approval.


 


Regulatory Authority means any
governmental or regulatory authority involved in granting Regulatory Approvals.


 


Remaining
Party means, on termination of this Agreement, the Party
designated as the Remaining Party under Article 12.1, 12.2, 12.3, 12.4(d),
12.5(b) or 12.6 (as appropriate).


 


Royalties means any
or all of (i) the ImClone Royalties; (ii) the royalties payable by either Party
pursuant to Article 8.2(b) on the sale of Antibody Products for Independent
Indications; and (iii) [***]
  [Confidential Treatment Required].


 


Royalty-Bearing
Patent Rights means the ImClone Core Patent Rights identified as
“Royalty-Bearing” in Part 4 of Schedule 1.


 


Term means the
term of this Agreement as set out in Article 12.1.


 


13





















 


[***]
  [Confidential Treatment Required]


 


Territorial
Lead means ImClone in the ImClone Territory; and UCB in
the UCB Territory.


 


Territory means all
the countries of the world.


 


Third Party means any
person, partnership, joint venture, corporation, trust, estate, unincorporated
organisation, government or any department or agency of any of them, or any
other entity other than a Party or any of its Affiliates.


 


Trademark means any
corporate name, trade name, service mark, service name, house mark, trade dress,
trade mark or logo, in each case whether or not registered, and all
applications for, and registrations of, and all renewals, extensions or
modifications to, and any goodwill associated with, any of them in the
Territory.


 


UCB Core
Patent Rights means those UCB Patent Rights identified as such in
Part 3 of Schedule 1.


 


UCB Company
Marks means the Trademarks Controlled by UCB or its
Affiliates, whether on the Effective Date or during the Term, that are
designated by UCB pursuant to Article 6.12(b) for use in connection with the
Development and Commercialisation of an Antibody Product under the Agreement.


 


UCB
In-Licences means the licences listed in Part 1 of Schedule 1, as
may be amended from time to time, each one a UCB In-Licence.


 


UCB Know-How
means any and all Information and Materials that are Controlled by UCB
or any of its Affiliates at any time during the Term that [***]   [Confidential Treatment
Required]; provided, however, that any Information and
Materials acquired by UCB or any of its Affiliates after the Effective Date,
whether by licence, merger, acquisition or otherwise, [***]   [Confidential Treatment
Required].  UCB Know-How excludes
(i) any Information and Materials included in the Joint Know-How; (ii) any
Information and Materials expressly excluded from this definition pursuant to
Article 10.8(b); (iii) the UCB Patent Rights; and (iv) Joint Patent Rights.


 


UCB Patent
Rights means any and all Patent Rights that are Controlled
by UCB or any of its Affiliates, in each case which if not licensed in this
Agreement would be infringed by Developing, Commercialising, making, having
made, using, selling, having sold, offering to sell or resell, importing,
exporting, distributing or otherwise transferring physical possession of or
otherwise transferring title in or to an Antibody Product in the Field,
including any Patent Rights which claim UCB Know-How; provided, however, that any Patent Rights
that are acquired by UCB or any of its Affiliates after the Effective Date,
whether by licence, merger, acquisition or otherwise, [***]   [Confidential Treatment
Required].  UCB Patent Rights excludes the Joint Patent Rights and those
Patent Rights expressly excluded from this definition pursuant to Article
10.8(b).  As of the Effective Date, UCB Patent Rights include those Patent
Rights set out in Part 3 of Schedule 1.


 


UCB
Territory means the Territory excluding the ImClone Territory.


 


14





















 


Valid Claim means,
with respect to a particular country, any claim of a [***]   [Confidential Treatment
Required] Patent Right in such country that (i) has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal, and (ii) has not been abandoned,
disclaimed, denied or admitted to be invalid or unenforceable through reissue,
re-examination, disclaimer or otherwise.


 


1.2                               Each
of the following definitions is found in this Agreement as indicated.


 


	
  Defined Terms

  	
   

  	
  Page/Article/Schedule

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Acquired Party

  	
   

  	
  Article 17.14

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Acquiring Party

  	
   

  	
  Article 10.8(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Additional Manufacturing Amount

  	
   

  	
  Article 7.13(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Agreement

  	
   

  	
  Pg. 3, first paragraph

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Antibody Product Specifications

  	
   

  	
  Article 7.2(g)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Antibody Product Standards

  	
   

  	
  Article 7.8(d)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  BLA

  	
   

  	
  Article 1.1, def. Drug Approval Application

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  CEDR

  	
   

  	
  Article 15.4

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  CEO Period

  	
   

  	
  Article 15.3

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Challenging Party

  	
   

  	
  Article 12.6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  COGM

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Commercialisation Budget

  	
   

  	
  Article 6.8(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Commercialisation Team Leader

  	
   

  	
  Article 6.3(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Competing Activity

  	
   

  	
  Article 12.3(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Continuing Indications

  	
   

  	
  Article 12.8(a)(i)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Continuing Party

  	
   

  	
  Article 8.1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Controlling Party

  	
   

  	
  Article 10.4(c)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Conversion

  	
   

  	
  Article 8.9(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Convert

  	
   

  	
  Article 8.9(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Converted Agreed Indication

  	
   

  	
  Article 8.9(f)

  	
   

  



 


15





















 


	
  Country Plan

  	
   

  	
  Article 6.6(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  CP Conversion

  	
   

  	
  Article 16.5(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  CP Conversion Notice

  	
   

  	
  Article 16.5(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Cure Period

  	
   

  	
  Article 12.4(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Default

  	
   

  	
  Article 12.4(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Default Conversion

  	
   

  	
  Article 8.9(a)(ii)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Defaulting Party

  	
   

  	
  Article 12.4(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Development Budget

  	
   

  	
  Article 4.5(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Development Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Development Team Leader

  	
   

  	
  Article 4.6(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Dispute

  	
   

  	
  Article 15.1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Distribution Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Effective Date

  	
   

  	
  Pg. 3, first paragraph

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Excluded Party

  	
   

  	
  Article 12.3(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Filing Party

  	
   

  	
  Article 5.1(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  First Contract Year

  	
   

  	
  Article 1.1, def. Contract Year

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  FTE

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  FTE Cost

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Gross Receipts

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ImClone

  	
   

  	
  Pg. 3, paragraph (2)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ImClone Royalties

  	
   

  	
  Article 6.15(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Indemnitees

  	
   

  	
  Article 14.1(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Independent Indication

  	
   

  	
  Article 8.1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Information Request

  	
   

  	
  Article 8.9(a)(i)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Initial Payment Period

  	
   

  	
  Article 8.2(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Insolvency Event

  	
   

  	
  Article 12.5(b)(iii)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Joint Activities

  	
   

  	
  Article 6.4(a)(ii)

  	
   

  



 


16





















 


	
  LCIA

  	
   

  	
  Article 15.3

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Losses

  	
   

  	
  Article 14.1(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Managing Party

  	
   

  	
  Article 10.5(e)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturer

  	
   

  	
  Article 7.2(c)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Agreement

  	
   

  	
  Article 7.2(d)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Coordinator

  	
   

  	
  Article 7.2(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Know How

  	
   

  	
  Article 7.8(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Patents

  	
   

  	
  Article 7.8(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Plan

  	
   

  	
  Article 7.2(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Manufacturing Team Leader

  	
   

  	
  Article 7.1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Marketing Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Markings

  	
   

  	
  Article 6.12(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Merging Party

  	
   

  	
  Articles 16.4

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Net Receipts

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Net Sales

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Non-Acquired Party

  	
   

  	
  Article 17.14

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Non-Challenging Party

  	
   

  	
  Article 12.6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Non-Continuing Party

  	
   

  	
  Article 8.1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Non-Defaulting Party

  	
   

  	
  Article 12.4(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Non-Remaining Party Indemnitees

  	
   

  	
  Article 14.1(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Notice of Default

  	
   

  	
  Article 12.4(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Operating Profits and Losses

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Operating Statement

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Option Exercise Notice

  	
   

  	
  Article 8.9(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Opt-Out Date

  	
   

  	
  Article 16.2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Other Out of Pocket Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Patent Costs

  	
   

  	
  Schedule 2

  	
   

  



 


17





















 


	
  Phase I Clinical Study

  	
   

  	
  Article 1.1, def. Clinical Study

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Phase II Clinical Study

  	
   

  	
  Article 1.1, def. Clinical Study

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Phase III Clinical Study

  	
   

  	
  Article 1.1, def. Clinical Study

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Phase IV Clinical Study

  	
   

  	
  Article 1.1, def. Clinical Study

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Post-Approval Study Expenses

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Pre-Marketing Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Product Trademark Owner

  	
   

  	
  Article 10.1(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Recall

  	
   

  	
  Article 5.5(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Reimbursable Costs

  	
   

  	
  Article 8.9(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Reimbursable Commercial Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Reimbursement Amount

  	
   

  	
  Article 8.9(c)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Relevant Net Sales

  	
   

  	
  Article 8.2(b)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Relevant Supply

  	
   

  	
  Article 7.13(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Representatives

  	
   

  	
  Article 14.1(b)(i)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Responsible Party

  	
   

  	
  Article 10.7(b)(v)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Royalty Term

  	
   

  	
  Article 6.15(c)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Sales Costs

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Sales Returns and Allowances

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  SOPs

  	
   

  	
  Article 5.5(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Terminating Party

  	
   

  	
  Article 12.2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [***]
    [Confidential Treatment Required]

  	
   

  	
  [***]
    [Confidential Treatment Required]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Third Party Claims

  	
   

  	
  Article 14.1(a)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Third Party Licence Fees

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Transfer Price

  	
   

  	
  Schedule 2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Transition Period

  	
   

  	
  Article 12.8(a)(i)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Transition Plan

  	
   

  	
  Article 12.8(a)(i)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  UCB

  	
   

  	
  Pg. 3, paragraph (1)

  	
   

  



 


18





















 


2.                                      SCOPE OF COLLABORATION


 


2.1                               Collaboration Goals


 


(a)                                  Pursuant and
subject to the terms of this Agreement:


 


(i)                                     each Party shall
use [***]  
[Confidential Treatment Required] to carry out the Development
activities assigned to it pursuant to, and in accordance with, the Development
Plan, as amended from time to time;


 


(ii)                                  ImClone
shall use [***]
  [Confidential Treatment Required] to obtain all
necessary Regulatory Approvals as soon as reasonably practicable in [***]   [Confidential Treatment
Required] for each Antibody Product for each Agreed Indication;


 


(iii)                               UCB
shall use [***]
  [Confidential Treatment Required] to obtain all
necessary Regulatory Approvals as soon as reasonably practicable in [***]   [Confidential Treatment
Required], for each Antibody Product for each Agreed
Indication;


 


(iv)                              each
Party shall use [***]
  [Confidential Treatment Required] to Commercialise
each Antibody Product for each Agreed Indication for which Regulatory Approval
has been obtained; and


 


(v)                                 the Parties shall
share Operating Profits and Losses of Antibody Products in the manner set forth
in Articles 2.3(b), 8.9, 12.10 and 16.5(c) and UCB shall pay ImClone the
ImClone Royalties as set forth in Article 6.15.


 


(b)                                 Subject to Article
4.7(f), the Parties acknowledge that the sole initial focus of the Development
shall be of CDP-791 in the Field as set forth in the outline for the
Development Plan set forth in Schedule 3. 
Either Party may, from time to time, notify the other Party in writing
that it wishes to extend the focus of the Development to include other
Antibodies in the Field, provided
that there shall be no amendment to the focus of the Development unless and
until the other Party, in its sole discretion, consents in writing to such
extension of the focus.


 


(c)                                  Each Party shall co-operate
with and provide reasonable support to the other Party in performing its
activities with respect to the Development and Commercialisation work
contemplated under this Agreement.


 


(d)                                 Notwithstanding
anything in this Agreement to the contrary, but without expanding each Party’s
diligence obligation under Article 2.1(a), neither Party (or any of its
Affiliates) shall take any action or, with respect to the implementation of the
responsibilities assigned to it under the Development Plan, Commercialisation
Plan, Manufacturing Plan or otherwise under this Agreement, fail to take any
action with respect to the Development,


 


19





















 


Manufacturing or Commercialisation of an Antibody Product, whether for
an Agreed Indication or an Independent Indication, that it knows, or should
know, is reasonably likely to have a material adverse affect on the
Development, Manufacture or Commercialisation of an Antibody Product in [***]   [Confidential Treatment
Required], unless it has first consulted with, and obtained
prior written consent to take or refrain from taking such action from, the JDT
(where the adverse affect would be on Development), the JMT (where the adverse
effect would be on Manufacturing), and/or the JCT (where the adverse affect
would be on Commercialisation) [***]   [Confidential Treatment Required], provided that any Dispute as to any
proposed act or omission shall be resolved in accordance with Article 15 [***]   [Confidential Treatment
Required].


 


2.2                               Exclusive Collaboration


 


Except as provided in Article 16.4, the Parties
agree that for the duration of this Agreement [***]   [Confidential Treatment
Required] they and their Affiliates will Develop, Commercialise and Manufacture
Antibody Products in the Field in the Territory exclusively within the scope of
this collaboration and subject to the terms of this Agreement and, other than
as explicitly permitted under this Agreement (including with respect to
permitted sublicensees or Distributors), will not undertake or enable any Third
Party to Develop, Commercialise or Manufacture any Antibody Products in the
Field without the other Party’s prior written consent.


 


2.3                               Financials and Audit Rights


 


(a)                                  UCB shall pay
ImClone the royalties as described in Article 6.15.


 


(b)                                 Subject to Articles
8.9, 12.10 and 16.5, during the Term the Parties shall share Operating Profits
and Losses as follows:


 


(i)                                     except as provided
in Article 2.3(b)(ii), for each Antibody Product, each Party is entitled to and
responsible for fifty per cent. (50%) of Operating Profits and Losses; and


 


(ii)                                  for an
Antibody Product for an Independent Indication (A) if ImClone is the Continuing
Party for such Independent Indication, then, except as otherwise expressly
provided in this Agreement, [***]   [Confidential Treatment Required]
entitled to and responsible for [***]   [Confidential Treatment Required] of
Operating Profits and Losses for such Antibody Product for such Independent
Indication in the [***]
  [Confidential Treatment Required], and in accordance
with Articles 4.7(d), 8.1 and 8.2, [***]   [Confidential Treatment Required] for
such Antibody Product for such Independent Indication in the [***]   [Confidential Treatment
Required], and (B) if UCB is the Continuing Party for such
Independent Indication, then, except as otherwise expressly provided in this
Agreement, [***]
  [Confidential Treatment Required] is entitled to and
responsible for [***]
  [Confidential Treatment Required] of Operating
Profits and Losses for such Antibody Product for such Independent Indication in
the [***]  
[Confidential Treatment Required], and in accordance with


 


20





















 


Articles 4.7(d), 8.1 and 8.2, [***]   [Confidential Treatment Required] for
such Antibody Product for such Independent Indication in the [***]   [Confidential Treatment
Required].


 


(c)                                  Within [***]   [Confidential Treatment
Required] from the end of each calendar month, each Party shall
submit to the other Party a written report setting out, on an
activity-by-activity basis, the Development Costs it has incurred in that
calendar month (or, where such information is not available, a reasonable
estimate of such Development Costs) as against the amount budgeted for that
activity in the Development Budget.


 


(d)                                 From the date of
the First Commercial Sale of an Antibody Product each Party during the Term and
thereafter the Remaining Party shall within [***]   [Confidential Treatment Required] after
the end of each Calendar Quarter deliver to the other Party a detailed report
showing:


 


(i)                                     the Net Sales and
the units of each Antibody Product sold by such first Party or the Remaining
Party, its Affiliates and their respective Distributors and sublicensees in the
countries for which such Party is the Territorial Lead during the applicable
Calendar Quarter on a country by country basis;


 


(ii)                                  during
the Term if such first Party is a Continuing Party, the Net Sales and units of
each Antibody Product sold by such first Party, its Affiliates and their
respective Distributors and sublicensees in a country for which such Party is
the Territorial Lead for use in an Independent Indication for which such Party
is the Continuing Party during the applicable Calendar Quarter on a country by
country basis using the allocation methodology agreed to by the Parties
pursuant to Article 8.3 together with such support for such sales as the other
Party may reasonably request; and


 


(iii)                               the
amount of Royalties payable and if applicable the breakdown of the calculation
of the Net Sales under paragraphs (i) and (ii) above during the applicable
Calendar Quarter.


 


(e)                                  On receipt of each
report for a Calendar Quarter delivered by one Party pursuant to Article
2.3(d), the other Party will issue an invoice for the Royalties payable as
specified in Article 2.3(d)(iii). 
Royalties shall be payable, with respect to each Calendar Quarter,
within [***]  
[Confidential Treatment Required] after receipt of such
invoice.  Royalties shall be calculated
in accordance with GAAP and with the terms of this Article 2.3 and as
applicable Article 6.15, Article 8.2 and Article 12.9(a) or Article 0.


 


(f)                                    Except as otherwise
provided in this Agreement, other payment, accounting and financial rights and
obligations of the Parties are set forth in Schedule 2.  Subject to Article 2.3(l), all Disputes
related to payment, accounting and financial rights and obligations of the
Parties shall be referred to the Collaboration Committee, and if the
Collaboration Committee is unable to resolve such Dispute, the Dispute shall be
decided under the provisions of Article 15 [***]   [Confidential Treatment Required].


 


21





















 


(g)                                 All amounts due
from one Party to the other Party under this Agreement shall be paid in Dollars
by wire transfer in immediately available funds to an account designated by the
receiving Party.  Any payments or
portions due hereunder that are not paid on the date such payments are due
under this Agreement shall bear interest at a rate equal to the lesser of LIBOR
[***]  
[Confidential Treatment Required], and the maximum rate
permitted by law, calculated on the number of days such payment is delinquent,
compounded monthly.  For the purpose of
this Article 2.3(g) LIBOR means the British Bankers’ Association Interest
Settlement Rate for the relevant currency and period as displayed on the
appropriate page of the Telerate screen. 
If the Telerate screen is replaced or the service ceases to be
available, the Parties shall agree a reasonable alternative page or service
displaying the appropriate rate.


 


(h)                                 If any currency
conversion shall be required in connection with any payment due under this
Agreement, such conversion shall be made by using the exchange rate for the
purchase of Dollars as published in The Wall Street Journal, Eastern Edition,
on the last Business Day of the Calendar Quarter or the calendar month (as the
case may be) to which such payments relate.


 


(i)                                     The Parties shall
maintain (and shall ensure that their Affiliates and respective sublicensees
and Distributors maintain) complete and accurate books, records, accounts and
supporting data that fairly and accurately reflect their respective Net Sales,
Gross Receipts, Sales Returns and Allowances, the Transfer Price, Distribution
Costs, Development Costs, Patent Costs, Pre-Marketing Expenses, Marketing
Costs, Sales Costs, Post-Approval Study Expenses and Other Out of Pocket Costs
and COGM in sufficient detail to confirm the accuracy of any payments required
under this Agreement and in accordance with GAAP, which books, records,
accounts and supporting data shall be retained by such Party until the later of
(i) [***]  
[Confidential Treatment Required] after the end of the period
to which such books, records, accounts and supporting data pertain; and (ii)
the expiration of the applicable tax statute of limitations (or any extensions
thereof), or for such longer period as may be required by Applicable Law.


 


(j)                                     Each Party shall
have the right for a period of [***]   [Confidential Treatment Required] after
receiving or making any payment under this Agreement from or to the other Party
to have an independent certified public accounting firm of internationally
recognised standing, reasonably acceptable to such other Party, have access
during normal business hours, and upon reasonable prior written notice, to such
of the books, records, accounts and supporting data of such other Party (and
its Affiliates and their respective sublicensees and Distributors) as may be
reasonably necessary to verify the accuracy of that payment.  The auditing Party shall not have the right
to conduct more than [***]
  [Confidential Treatment Required] such audit in any [***]   [Confidential Treatment
Required] period during the Term, unless an earlier audit in
such period revealed a material inaccuracy in the payment or such audit is
required by Applicable Law.  The accounting
firm shall disclose in writing to each Party whether such payments are correct
or incorrect and the specific details concerning any discrepancies.  The auditing Party shall bear


 


22





















 


the cost of such audit unless the audit reveals a variance in the amount
that should have been paid of more than [***] [Confidential Treatment Required]
for the period from the Effective Date or the date of the previous audit (whichever
is later) until the date of the audit, in which case the audited Party shall
bear the cost of the audit.  The results
of such audit shall be final, absent manifest error.  If, based on the results of any such audit, additional
payments or refunds are owed by a Party under this Agreement, that Party shall
make such additional payments or refunds, with interest from the date
originally due, as applicable, [***] [Confidential Treatment Required] after
the date on which such accounting firm’s written report is delivered to the
Parties.


 


(k)                                  No Royalties shall
be taken into account in the calculation of Operating Profits or Losses.


 


(l)                                     Any Dispute
pertaining to whether any Royalties, other than the [***] [Confidential
Treatment Required], are payable in respect of any sale of an Antibody Product
shall be determined by the JCT.  If the
JCT cannot resolve any such Dispute it shall be referred to the Collaboration
Committee for resolution and if the Collaboration Committee is unable to
resolve such Dispute, the Dispute shall be decided under the provisions of
Article 15 [***] [Confidential Treatment Required].


 


2.4                               Employee Obligations


 


Prior to beginning work relating to any aspect
of the subject matter of this Agreement or being given access to UCB Know-How
or ImClone Know-How, each employee, consultant or agent of ImClone and UCB,
respectively, and their respective Affiliates, sublicensees and Distributors,
shall be bound by an agreement pursuant to which:


 


(a)                                  each such person
(other than administrative or non-technical personnel) shall (but in the case
of a Party’s own Information and Materials, only to the extent such Party’s
employees, consultants or agents are conducting activities pursuant to this
Agreement) be obliged to:


 


(i)                                     follow such Party’s
policies and procedures regarding reporting any invention, discovery,
process, software program, Information or Material characterised, conceived,
developed, derived, discovered, generated, identified or otherwise made by such
person in the course of his or her employment or retainer with such Party, including
any intellectual property or proprietary right thereto, that falls within Joint
Know-How, UCB Know-How or ImClone Know-How;


 


(ii)                                  assign
to such Party all of his or her right, title and interest in and to any such
invention, discovery, process, software program, Information or Material
characterised, conceived, developed, derived, discovered, generated, identified
or otherwise made by such person in the course of his or her employment or
retainer with such Party, including any intellectual property or proprietary
right thereto;


 


(iii)                               co-operate
in the preparation, filing, prosecution, maintenance, defence and enforcement
of any Patent Rights claiming the same; and


 


23





















 


(iv)                              perform
all acts and sign, execute, acknowledge and deliver any and all papers,
documents and instruments required for effecting the obligations and purposes
of that agreement; and


 


(b)                                 each person shall
be bound by obligations of confidentiality and non-use consistent with the
terms of this Agreement.  It is
understood and agreed that any such agreement need not be specific to this
Agreement.


 


2.5                               1121B


 


Each Party acknowledges and agrees that any
activities conducted by or on behalf of ImClone or its Affiliates with respect
to 1121B prior to (and including) the date (if any) ImClone provides UCB with
its written confirmation and undertaking pursuant to Article 16.3, do not
constitute activities conducted under or in connection with this
Agreement.  Notwithstanding any other
provision in this Agreement, ImClone has no obligation to transfer any
Materials relating to 1121B prior to that date and thereafter any transfer of
such Materials shall be subject to Article 4.10.


 


3.                                      COLLABORATION MANAGEMENT


 


3.1                               Establishment of the Collaboration Committee


 


Within [***] [Confidential Treatment Required]
after the Effective Date, the Parties shall form a Collaboration
Committee.  The Collaboration Committee
shall be composed of an equal number of representatives of each Party (up to a
maximum of [***] [Confidential Treatment Required] representatives per Party)
appointed (and may be replaced at any time) by such Party on written notice to
the other Party.  At least [***]
[Confidential Treatment Required] such representative from each of UCB and
ImClone, respectively, shall, prior to establishment of the JCT, be a Vice
President and, after establishment of the JCT, be a Senior or Executive Vice
President or equivalent of their respective company, and all such
representatives shall be individuals of suitable authority and seniority with
significant experience or expertise in biopharmaceutical drug development,
commercialisation or marketing.  Any
member of the Collaboration Committee may designate a substitute of equal
experience and seniority to attend and perform the functions of that member at
any meeting of the Collaboration Committee. 
Each Party may invite (at its discretion and with the consent of the
other Party) additional employees, or consultants to attend Collaboration
Committee meetings.


 


3.2                               Collaboration Committee Responsibilities


 


The Collaboration Committee shall have the
general responsibility of overseeing the Development of Antibody Products for
Agreed Indications according to the Development Plan, overseeing the
Commercialisation of Antibody Products in the Field in the Territory according
to the Commercialisation Plan, establishing and managing the annual Development
Budget and Commercialisation Budget, overseeing the Manufacturing of the
Antibody Products in accordance with the Manufacturing Plan, coordinating a
regular flow of information between the Parties, managing the relationship
between the Parties, and more generally, making all necessary strategic
decisions relating to the collaboration under this Agreement.  In addition, the Collaboration Committee
shall, subject to the terms of this Agreement:


 


24





















 


(a)                                  approve the initial
Development Plan, Development Budget, Commercialisation Plan, Commercialisation
Budget and Manufacturing Plan and approve any updates and amendments thereto;


 


(b)                                 determine from time
to time whether or not the Parties should continue Development, Manufacturing
and Commercialisation of an Antibody Product for an Agreed Indication;


 


(c)                                  serve as the first
forum for attempted settlement of disputes or disagreements arising in other
Committees or any other Disputes as set forth in Article 15.1;


 


(d)                                 approve all Product
Trademarks and generic names proposed by the JCT for use with respect to an
Antibody Product in consultation with the JPC;


 


(e)                                  approve all
protocols, and changes to protocols, for Clinical Studies for all Antibody
Products for Agreed Indications proposed by the JDT;


 


(f)                                    review all
protocols, and changes to protocols, for Clinical Studies for all Antibody
Products for Independent Indications referred by the JDT;


 


(g)                                 review all
protocols for Post-Approval Studies in support of Compendia Listings referred
by the JDT;


 


(h)                                 approve all
recommendations of the JCT with respect to the product positioning, pricing and
reimbursement issues for all Antibody Products;


 


(i)                                     approve all
recommendations of the JDT with respect to the packaging, labelling and
language to be included in the Product Labelling of all Antibody Products; and


 


(j)                                     perform such other
functions as are allocated to it under the other provisions of this Agreement
or as appropriate to further the purposes of this Agreement as determined by
the Parties.


 


3.3                               Decision Making; Administrative Matters


 


(a)                                  Collaboration
Committee Decision-Making


 


All decisions of the Collaboration Committee
shall be made by the [***] [Confidential Treatment Required], with the
representatives of each Party who are members of the Collaboration
Committee[***] [Confidential Treatment Required] in any matter requiring the approval
of the Collaboration Committee.  The
Parties agree that all decisions by the Collaboration Committee regarding the
Development, Commercialisation or Manufacture of an Antibody Product shall be
made in the interests of maximising the long-term value of the Antibody Product
on a global basis.  If the Collaboration
Committee is unable to resolve a dispute regarding any issue, the matter shall
be resolved pursuant to the dispute resolution process set forth in Article 15.


 


25





















 


(b)                                 Procedural
Rules


 


The Collaboration Committee shall establish its
own procedural rules for its operation consistent with the terms of this
Article 3.  A chairperson for the
Collaboration Committee shall be appointed from among its members.  The chairperson shall be appointed on an
annual basis and shall alternate each Contract Year between a UCB
representative and an ImClone representative, UCB being responsible for
designating the chairperson for the first Contract Year.  The chairperson shall be responsible for
calling meetings of the Collaboration Committee in accordance with Article
3.3(c) and for leading the meetings.  One
member representing the Party that did not appoint the chairperson shall serve
as secretary of that meeting.  The
secretary of the meeting shall prepare and distribute ([***] [Confidential
Treatment Required] following each meeting) to all members of the Collaboration
Committee the minutes of the meeting. 
Such minutes shall provide a description in reasonable detail of the
discussions held at the meeting and a list of any actions, decisions or
determinations approved by the Collaboration Committee at such meeting.  The minutes of each Collaboration Committee
meeting shall be approved or disapproved by each Party’s Collaboration
Committee representatives, and revised as necessary, at the next meeting of the
Collaboration Committee.  Final minutes
of each meeting shall be distributed promptly thereafter to the members of the
Collaboration Committee by the chairperson.


 


(c)                                  Meetings


 


The Collaboration Committee shall meet at least
every [***] [Confidential Treatment Required] and in addition within [***]
[Confidential Treatment Required] of a request by any Collaboration Committee
member to have such a meeting.  Such
meetings shall be held at such times as are mutually agreed upon by the
Collaboration Committee.  Meetings may
take place by video conference or telephone conference or such other means as
the Collaboration Committee shall decide, provided,
however, that all members of the
Collaboration Committee shall meet in person at least once per Contract Year,
unless otherwise agreed by the Parties. 
Meetings held in person shall alternate between ImClone and UCB
designated locations.  The first meeting
shall be held at UCB’s facilities.


 


(d)                                 Appointment
of Sub-Teams and Subcommittees


 


The Collaboration Committee is empowered to
create such sub-teams or subcommittees of itself as it may deem appropriate or
necessary.  Each such sub-team or
subcommittee shall report to the Collaboration Committee, who shall have
authority to approve or reject recommendations or actions proposed subject to
the terms of this Agreement.  No sub-team
or subcommittee shall have authority to make any decision binding upon the
Collaboration Committee or the Parties. 
For the avoidance of doubt, a Party may appoint an individual as its
representative on more than one Committee.


 


3.4                               Establishment of the Joint Patent Committee or JPC


 


[***] [Confidential Treatment Required] after
the Effective Date, the Parties shall establish a JPC.  The JPC shall be comprised of one (1) senior
patent attorney from each Party as appointed by such Party.  A Party may replace its representative from
time to time upon written notice to the other Party.  The JPC shall exist until the expiration or
termination of this Agreement.  All
decisions of the JPC shall be


 


26





















 


unanimous. 
In the event that a decision cannot be reached by the JPC, the dispute
shall be resolved pursuant to the dispute resolution process set forth in
Article 15.  Unless the Parties otherwise
agree, the JPC shall continue after termination of this Agreement for the
purpose of co-ordinating the Parties activities in relation to Joint Patent
Rights but for no other purpose.


 


3.5                               Joint Patent Committee Responsibilities


 


The JPC shall be responsible for:


 


(a)                                  reviewing and, so
far as permitted in Article 10, approving patent, trademark and other
intellectual property strategy and, to the extent applicable, patent, trademark
and other intellectual property litigation strategy;


 


(b)                                 coordinating
patent, trademark and other intellectual property related activities as
allocated to it pursuant to this Agreement;


 


(c)                                  consulting with the
Collaboration Committee with regard to proposals by the JCT for Product
Trademarks and generic names for use with respect to an Antibody Product;


 


(d)                                 following approval
of Product Trademarks for Antibody Products by the Collaboration Committee,
obtaining and maintaining the Product Trademarks and domain names incorporating
any of the same or otherwise referencing Antibody Products;


 


(e)                                  periodically
reporting to the Collaboration Committee on the status of intellectual property
matters affecting the Development, Commercialisation and Manufacture of
Antibody Products as requested by the Collaboration Committee; and


 


(f)                                    in accordance with
Article 10.1(e) and subject to Articles 15.1 and 15.6, making decisions
relating to the characterisation of any Information, Materials or Patent Rights
as ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and Joint
Patent Rights, including during any transfer plan or Transition Plan
established under Articles 8.6 and 12.8.


 


3.6                               Limitations on the Authority of Committees and Teams


 


Notwithstanding the Committee structure
established pursuant to this Agreement, each Party shall retain the rights,
powers and discretion granted to it under this Agreement, and no such rights,
powers, or discretion shall be delegated to or vested in a Committee unless
such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing.  For clarity, amendments to this Agreement may
only be made in accordance with Article 17.1.


 


3.7                               Operational and Day-to-Day Decisions


 


Subject to Article 2.1(d), all operational and
day-to-day decisions with respect to matters and functions allocated or
delegated to a Party in the Development Plan, the Manufacturing Plan or the
Commercialisation Plan, or, with respect to Independent Indications, assigned
to the Continuing Party under this Agreement, unless


 


27





















 


specifically reserved for approval by a
Committee hereunder, shall be deemed to be within the decision-making authority
of such Party; provided that all
such decisions shall be consistent with the Development Plan, Commercialisation
Plan and Manufacturing Plan, as applicable, the scope of such allocation or
delegation and the terms and conditions of this Agreement.


 


4.                                      DEVELOPMENT OF ANTIBODY PRODUCTS


 


4.1                               Activities


 


Without limiting the obligations under Article
2.1 or the Development Plan, each Party shall undertake the following
activities:


 


(a)                                  subject to Article
4.10 in relation to Materials, from time to time transfer to the other Party
ImClone Know-How and UCB Know-How in such Party’s Control [***] [Confidential
Treatment Required] to conduct its Development activities under the Development
Plan in respect of Antibody Products for Agreed Indications or to conduct its
Development activities in respect of Antibody Products for Independent
Indications for which the other Party is the Continuing Party;


 


(b)                                 conduct, or, as
applicable, assist the other Party in conducting, all relevant studies,
including Clinical Studies, for Antibody Products for Agreed Indications and,
[***] [Confidential Treatment Required], assist such other Party in conducting
such studies for Antibody Products for Independent Indications for which such
other Party is the Continuing Party; and


 


(c)                                  in a manner
consistent with Article 5 and the other terms of this Agreement, make, or, as
applicable, assist the other Party in making, all filings with and supporting
all communications with the relevant Regulatory Authorities or other
governmental or regulatory entities necessary to conduct such studies or to
seek Regulatory Approvals for Antibody Products for Agreed Indications and, if
applicable, Independent Indications for which the other Party is the Continuing
Party.


 


4.2                               Collaboration Development


 


Each Antibody Product shall be Developed by the
Parties for each Agreed Indication for such Antibody Product in accordance with
the Development Plan unless and until such Agreed Indication becomes an
Independent Indication pursuant to Article 8.


 


4.3                               Costs


 


Subject to Articles 4.5, 8.9 and the other
terms of this Agreement, ImClone and UCB shall bear Development Costs as
follows:


 


(a)                                  Development
Costs in Agreed Indications


 


The Parties shall share equally in all
Development Costs related to the Development of an Antibody Product for Agreed
Indications incurred in the conduct of the Development Plan and, subject to
Article 4.5, in accordance


 


28





















 


with the Development Budget, regardless of
whether such expenses are incurred before, on or after the Effective Date.


 


(b)                                 Development
Costs in Independent Indications


 


The Development Costs related to the
Development of an Antibody Product for an Independent Indication shall be borne
solely by the Continuing Party [***] [Confidential Treatment Required].


 


4.4                               Quarterly Reconciliation of Development Costs


 


The Parties shall use the procedure set out in
Schedule 2 for any applicable reconciliation of Development Costs.


 


4.5                               Development Budget


 


(a)                                  Each Party shall
prepare and submit to the other Party (via the JDT) for each Contract Year a
proposed budget for its activities for such Contract Year, in accordance with
the Development Plan, in support of the Development of Antibody Products for
Agreed Indications in a format to be agreed by the Parties, but which budget
must include (i) line item estimates of Development Costs for each Agreed
Indication by function for that Contract Year; and (ii) in respect of any
Development activities which will not be completed within that Contract Year
line item estimates of the total Development Costs required to complete such
Development activities on an activity-by-activity basis (regardless of whether
such Development Costs will be incurred in that Contract Year or subsequent Contract
Years).  Unless otherwise agreed by the
Parties, for the first Contract Year these budgets shall be submitted within
[***] [Confidential Treatment Required] after the date on which the
Collaboration Committee approves the initial Development Plan pursuant to
Article 4.7(a) and, thereafter, no later than [***] [Confidential Treatment
Required] prior to the start of each subsequent Contract Year.  Unless otherwise agreed by the Parties, the
Collaboration Committee shall review, revise and approve these budgets within
[***] [Confidential Treatment Required] after the date on which the
Collaboration Committee approves the initial Development Plan pursuant to
Article 4.7(a) and, thereafter, no later than [***] [Confidential Treatment
Required] prior to the commencement of each Contract Year (each such approved
budget, a Development Budget).  Once approved, the Collaboration Committee
shall modify the Development Budget from time to time based upon the results of
Clinical Studies and other unanticipated events, provided that save as set out in Article 4.5(b), in no event
shall the Development Budget for a Contract Year, or, any line item estimate
within the Development Budget for the total Development Costs required to
complete any Development activity which will not be completed within that
Contract Year, be varied by more than [***] [Confidential Treatment Required],
without the consent of the JDT (or the Collaboration Committee if the JDT
cannot agree), [***] [Confidential Treatment Required].  If the Development Plan is updated or amended
by the Collaboration Committee pursuant to Article 4.7 or Article 8.6 with
respect to the then-current Contract Year, the Parties shall prepare and submit
proposals for any


 


29





















 


necessary amendments to the Development Budget for such Contract Year
within [***] [Confidential Treatment Required] after such update or amendment
to the Development Plan and the Collaboration Committee shall review, revise
and approve any necessary amendments to the Development Budget for such
Contract Year [***] [Confidential Treatment Required] after such update or
amendment of the Development Plan.


 


(b)                                 In any Contract
Year, each Party shall promptly inform the other Party upon such Party
determining that it is likely to overspend or underspend by more than [***]
[Confidential Treatment Required] its respective total Development Costs for an
activity set forth in the Development Budget for that Contract Year.  If in any such Contract Year a Party exceeds
its budgeted costs and expenses by more than [***] [Confidential Treatment
Required] for an activity, the Party that has so exceeded its budget shall
provide to the JDT and to the Collaboration Committee (if the matter is
escalated to the Collaboration Committee because it cannot be resolved by the
JDT) a full explanation for exceeding the Development Budget for such
activity.  [***] [Confidential Treatment
Required], the JDT or Collaboration Committee (as applicable) may, by unanimous
agreement and not subject to a [***] [Confidential Treatment Required], allow
some or all of any other overspend to be included in the Development Costs as
it considers equitable under the circumstances. 
Where any Development Budget sets out a line item estimate for the total
Development Costs required to complete any activity which will not be completed
within that Contract Year:  [***]
[Confidential Treatment Required].  To
the extent that any overspend is not included in Development Costs as provided
in this Article 4.5, the Party who has exceeded its budget by more than [***]
[Confidential Treatment Required] will be solely responsible for the overspend.


 


4.6                               Establishment of Joint Development Team


 


Within [***] [Confidential Treatment Required]
after the Effective Date, the Parties shall form a Joint Development Team
(JDT).


 


(a)                                  The JDT shall
consist of up to [***] [Confidential Treatment Required] representatives of
each Party.  Each member of the JDT shall
have appropriate experience in the development of Antibody products.  One such representative from each Party shall
be designated as that Party’s Development
Team Leader to act as the primary JDT contact for that Party.  Together, the Development Team Leaders will
be jointly responsible for managing the JDT. 
Each Party’s Development Team Leader shall be responsible for ensuring
that his/her Party carries out the activities assigned to such Party under the
Development Plan.  Either Party may
replace any or all of its representatives on the JDT at any time upon written notice
to the other Party.  Any member of the
JDT may designate a substitute to attend and perform the functions of that
member at any meeting of the JDT.  Each
Party may invite [***] [Confidential Treatment Required] additional employees
or consultants to attend the JDT meetings. 
The JDT shall be empowered to create such sub-teams or subcommittees as
it may deem appropriate or necessary. 
Each such sub-team or subcommittee shall report to the JDT, which shall
have authority to approve or reject recommendations or actions proposed,
subject to the terms of this


 


30





















 


Agreement.  No sub-team or
subcommittee shall have authority to make any decision binding upon the JDT or
the Parties.  The JDT shall meet, at least
once each Calendar Quarter, or more frequently as agreed by the JDT.  To the extent that meetings are held in
person, the location of regularly scheduled JDT meetings shall alternate
between the offices of the Parties unless otherwise agreed.  Meetings may be held by videoconference or
telephonically.  Meetings shall be
chaired by a single JDT representative of one of the Parties, with the Party
responsible for designating the chairperson alternating each Contract Year and
with ImClone being responsible for designating the chairperson for the first
Contract Year.  The Party that does not
provide the chairperson shall designate a member of the JDT to record, in
sufficient detail, minutes of the discussions and decisions of the JDT.  Such minutes shall be circulated to the
Parties promptly following the meeting for review, comment and, after approval
from [***] [Confidential Treatment Required], distribution.  The Parties shall endeavour to manage the
business and meetings of the JDT in the most cost-effective way possible.


 


(b)                                 JDT
Responsibilities


 


With respect to the Development of Antibody
Products, the JDT shall have the responsibility, except as otherwise set forth
in this Agreement, of:


 


(i)                                     overseeing and
coordinating the day-to-day implementation of the Development Plan by the
Parties;


 


(ii)                                  reviewing
the outline for the Development Plan and making recommendations to the
Collaboration Committee with respect to the conversion of the outline for the
Development Plan into the initial Development Plan in accordance with Article
4.7 and, following approval of the initial Development Plan by the
Collaboration Committee, recommending updates and amendments to the Development
Plan to the Collaboration Committee in accordance with Article 4.7;


 


(iii)                               allocating
to the Parties responsibilities for Development activities that are not
otherwise assigned to a Party in the Development Plan, provided that no such allocation shall be
made (other than as provided in the Development Plan agreed by the Parties) to
a Party without such Party’s consent[***] [Confidential Treatment Required];


 


(iv)                              making
decisions regarding the design and strategic implementation of all Development
programmes for Agreed Indications and selecting and appointing contract
research organisations;


 


(v)                                 selecting and
designing Clinical Studies for Agreed Indications, and prior to the
commencement of each Clinical Study for Agreed Indications, specifying when
that Clinical Study will be deemed to be complete for the purposes of this
Agreement;


 


31





















 


(vi)                              proposing
protocols, and changes to protocols, for Clinical Studies for all Antibody
Products for Agreed Indications to the Collaboration Committee for approval;


 


(vii)                           reviewing
all designs and protocols for Clinical Studies for all Antibody Products for
Independent Indications that have been submitted by the Continuing Party
pursuant to Article 8.3 and referring such protocols to the Collaboration
Committee;


 


(viii)                        identifying
Manufacturing needs and requirements of Clinical Supplies of Antibody Products,
placebos and comparators and implementing an appropriate forecasting mechanism
to provide the Manufacturing Coordinator with sufficient lead-time to
Manufacture or have Manufactured and supply the Parties’ requirements of
Clinical Supplies of Antibody Products, placebos and comparators;


 


(ix)                                devising
the content of and filing strategy for Drug Approval Applications for Agreed
Indications;


 


(x)                                   reviewing and
approving any documents or reports to be filed by a Filing Party with the FDA
or any other Regulatory Authority with respect to Agreed Indications;


 


(xi)                                through
the representatives on the JDT with regulatory expertise and in consultation
with the JCT, coordinating interactions with Regulatory Authorities and
developing and implementing standard operating procedures for adverse event
reporting between the Parties and compliance with other regulatory requirements
in the Territory consistent with and subject to Article 5;


 


(xii)                             consulting
with the Continuing Party for an Antibody Product for an Independent Indication
with respect to the Development of such Antibody Product for such Independent
Indication;


 


(xiii)                          consulting
with the JCT as to the design and conduct of Post-Approval Studies;


 


(xiv)                         in consultation
with the JCT, making recommendations to the Collaboration Committee with
respect to the packaging, labelling and language to be included in the Product
Labelling of all Antibody Products;


 


(xv)                            reviewing
all designs and protocols for Post-Approval Studies in support of Compendia
Listings that have been submitted by either Party pursuant to Article 4.7(e)
and referring such protocols to the Collaboration Committee;


 


(xvi)                         exchanging
information and facilitating cooperation and coordination between the Parties
as they exercise their respective rights and meet their respective obligations
with respect to Development under this Agreement; and


 


32





















 


(xvii)                      resolving
any complaint by a Party that the Development, Commercialisation or
Manufacturing activities of the other Party are adversely affecting, or may
adversely affect, the Development of Antibody Products in the Territory of the
Party making the complaint.


 


The JDT will be responsible for all other activities
assigned to it by the Collaboration Committee with respect to Agreed
Indications and shall provide the Collaboration Committee with Quarterly
reports of its activities.


 


(c)                                  JDT
Decision-Making


 


Decisions of the JDT shall be made by [***]
[Confidential Treatment Required].  If
the JDT is unable to resolve a dispute regarding any issue, the matter shall be
resolved pursuant to the dispute resolution process set forth in Article 15.


 


(d)                                 Ceasing
of JDT Operations


 


The JDT will cease operations and have no
further function under this Agreement on the date on which the Parties are no
longer engaging in Development of any Antibody Product for an Agreed
Indication, provided that the JDT
shall recommence operations if the Parties recommence Development of an
Antibody Product for an Agreed Indication Converted pursuant to Article 8.9.


 


(e)                                  Annual
Development Reports


 


The JDT shall submit annual reports with
respect to the Development of Antibody Products for Agreed Indications to the
Collaboration Committee as part of each annual recommended update to the
Development Plan with respect to Agreed Indications.  The Continuing Party with respect to an
Independent Indication shall submit annual reports with respect to the Development
of Antibody Products for such Independent Indication to the Collaboration
Committee.  Each such report shall
include non-binding forecasts of the Parties’ requirements of Clinical Supplies
of Antibody Products, placebo and comparators for Agreed Indications and
Independent Indications (which forecasts shall be provided by the applicable
Continuing Party) for the Territory for the then current year and the following
[***] [Confidential Treatment Required] and any other related information that
the JDT determines, or is requested by the Collaboration Committee, to include.


 


4.7                               Development Plans and Additional Indications


 


(a)                                  The JDT shall
review the outline for the Development Plan, attached hereto as Schedule 3, and
shall make recommendations to the Collaboration Committee with respect to the
conversion of the outline for the Development Plan into the initial Development
Plan within [***] [Confidential Treatment Required] after the Effective
Date.  The Collaboration Committee shall
use all [***] [Confidential Treatment Required] to approve the initial
Development Plan as soon as reasonably practicable following receipt of such
recommendations from the JDT and in any event (unless otherwise agreed by the
Parties) no


 


33





















 


later than [***] [Confidential Treatment Required] after the Effective
Date.  Following agreement of the
Development Plan by the Collaboration Committee, the JDT shall review the
Development Plan at least Quarterly, and shall make recommendations to the
Collaboration Committee with respect to the initial Development Plan and
subsequently any updates or amendments thereto with respect to any existing
Agreed Indications or any proposed new Indications for an Antibody Product,
including for an earlier line of therapy for an existing Agreed
Indication.  Any such recommendations
shall include a good faith estimate of the budget for any such update or
amendment, including any changes in the existing Development Budget.  Each Party shall cooperate with the JDT in
preparing such estimated budget.


 


(b)                                 Neither the initial
Development Plan nor any update or amendment to the Development Plan shall
become effective until it is approved by the Collaboration Committee or, if the
Collaboration Committee cannot reach agreement on an update or amendment, until
such time as may be agreed in accordance with the dispute resolution process
set forth in Article 15.1(b).  Except as
provided in Article 8, any update or amendment shall provide for the joint
Development by the Parties of Antibody Products for the Agreed Indications and
shall, subject to the proviso in Article 4.6(b)(iii), assign responsibility for
Development activities between the Parties considering:  (i) the allocation of responsibility set out
in the initial Development Plan, (ii) the respective Territorial Lead, (iii)
expertise and available resources, and (iv) the ability to use the Parties’
respective existing facilities and infrastructure.


 


(c)                                  With respect to
additional Indications for an Antibody Product proposed by the JDT or one or
both of the Parties pursuant to Article 4.7(a), the Collaboration Committee
shall have the right with the mutual agreement of the Parties, in their sole
and absolute discretion, to designate such Indication as an Agreed Indication,
in which case the Collaboration Committee shall (i) approve any updates or
amendments to the Development Plan and Development Budget with respect thereto,
with any Disputes with respect to such updates and amendments to be resolved
pursuant to Article 15, but, for clarity, not the [***] [Confidential Treatment
Required] process in Article 15.2, and (ii) Develop and Commercialise such
Antibody Product for such Agreed Indication as provided in this Agreement.  [***] [Confidential Treatment Required].


 


(d)                                 If the Parties do
not agree to designate an Indication as an Agreed Indication for an Antibody
Product and the Development and Commercialisation of such Antibody Product for
such Indication is not, at that time, reasonably likely to have an adverse
effect on the Development and Commercialisation of the Antibody Product for
Agreed Indications in the Territory, then the Party that did not object to such
designation shall have the right, on written notice to the other Party provided
within [***] [Confidential Treatment Required] after the meeting of the
Collaboration Committee in which the Indication was rejected pursuant to
Article 4.7(c), to Develop and conduct Post-Approval Studies for such Antibody
Product for such Indication in the Territory and to seek, obtain and maintain
Regulatory Approval for and Commercialise such Antibody Product for such
Indication in any country in which such Party is the


 


34





















 


Territorial Lead, in each case as an
Independent Indication pursuant to Article 8 and the other Party shall have no
right to Develop or to seek, obtain or maintain Regulatory Approval for such
Indication in the countries for which such other Party is Territorial Lead
except as permitted in Article 8.9.  Any
Dispute as to whether the Development or Commercialisation of a new Indication
for an Antibody Product is reasonably likely to have an adverse effect on the
Development and Commercialisation of an Antibody Product for Agreed Indications
in the Territory shall be subject to the dispute resolution provisions of
Article 15[***] [Confidential Treatment Required].


 


(e)                                  Notwithstanding
anything in this Agreement to the contrary, neither Party shall have the right
to Develop an Antibody Product for an Indication other than an Agreed
Indication or an Independent Indication, including for another line of therapy
for an existing Agreed Indication or Independent Indication, inside or outside
of the scope of this Agreement without the consent of the other Party.  For clarity, each Party shall have the right
to conduct Post-Approval Studies in support of Compendia Listings for Antibody
Products for new Indications in accordance with the applicable
Commercialisation Plan and Applicable Law, provided that all designs and
protocols for such Post-Approval Studies in support of Compendia Listings have
been submitted to the JDT for review and, in the case of the protocols,
reviewed by the Collaboration Committee, prior to commencement of that
Post-Approval Study.


 


(f)                                    [***] [Confidential
Treatment Required]


 


4.8                               Compliance with Applicable Law


 


In performing Development activities, each
Party shall comply with all Applicable Law.


 


4.9                               Clinical Studies


 


(a)                                  Agreed
Indications


 


The Parties shall conduct Clinical Studies for Antibody Products for
Agreed Indications in accordance with the Development Plan.  All clinical data and reports related to
Clinical Studies for Antibody Products for Agreed Indications shall be [***]
[Confidential Treatment Required].  Each
Party shall have full use, for any purpose consistent with this Agreement, of
all such data and reports related to Clinical Studies in Agreed Indications for
an Antibody Product.  Once finalised, all
data, database information and reports from all Clinical Studies for Antibody
Products for Agreed Indications shall be centralised and held at a location to
be chosen by the Collaboration Committee, with a duplicate set available to
each Party for deposit at a site of its own selection.


 


(b)                                 Independent
Indications


 


All clinical data and reports related to Clinical Studies for
Independent Indications for an Antibody Product shall [***] [Confidential
Treatment


 


35





















 


Required] and that Continuing Party shall have the right to control all
such data, database information and reports from Clinical Studies for such
Independent Indication, including maintaining the foregoing at a separate
location.  The Non-Continuing Party with
respect to an Independent Indication for an Antibody Product shall not have the
right to use, access or reference such data, information or reports, provided that, subject to the restrictions
on Development and marketing set forth in Article 8.1, the Non-Continuing Party
shall have the right to reference such data and reports with respect to such
Independent Indication as are necessary to obtain and maintain Regulatory
Approvals for Agreed Indications for such Antibody Product or for other
Independent Indications for which such Non-Continuing Party is the Continuing
Party, in each case, in the countries in which the Non-Continuing Party is the
Territorial Lead.


 


4.10                        Development Materials


 


The Parties agree that (i) to the extent that a
Party would otherwise be required to transfer to the other Party Materials that
are [***] [Confidential Treatment Required]for the other Party to conduct its
Development activities under this Agreement, the transfer of such Materials
shall be at the discretion of the transferring Party; (ii) any Materials
provided by one Party to the other Party pursuant to this Agreement and any
Material produced against or with, or otherwise derived from, such Materials
shall be used solely for the Development activities as provided in the
Development Plan or the plan for Independent Indications referred to in Article
8.3(a), and in material compliance with all Applicable Law and, except as
agreed by the Parties, Materials provided to one Party by the other shall not
be made available to any Third Party by the receiving Party without the prior
written consent of the providing Party [***] [Confidential Treatment Required];
(iii) any Materials provided by one Party to the other Party pursuant to this
Agreement are provided without any warranties, express or implied; and (iv) all
right, title and interest in and to any Materials provided by one Party to the
other Party pursuant to this Agreement, including any replication, copy or
progeny thereof, shall be, and remain, vested in such providing Party.  Any Dispute in relation to this Article 4.10
shall be resolved by the Collaboration Committee and if the Collaboration
Committee is unable to resolve such Dispute, the Dispute shall be decided under
the provisions of Article 15 ([***] [Confidential Treatment Required]).


 


5.                                      REGULATORY AFFAIRS


 


5.1                               Rights and Responsibilities with respect to Antibody Products


 


(a)                                  The Parties shall
consult and cooperate with each other on all matters relating to, and in
communications with, Regulatory Authorities. 
The Parties will coordinate all communications with Regulatory
Authorities in [***] [Confidential Treatment Required] to ensure consistent and
clear communication with those Regulatory Authorities.  In addition, each Party will discuss in
advance with the other Party any planned communication with any Regulatory Authority
in [***] [Confidential Treatment Required].


 


(b)                                 Unless otherwise
agreed by the Parties or otherwise provided in this Agreement, the Territorial
Lead shall, as between the Parties, be responsible


 


36





















 


for filing and procuring the submission of the INDs and Drug Approval
Applications and seeking, obtaining and maintaining Regulatory Approvals for
Antibody Products for Agreed Indications in each country for which it is the
Territorial Lead (the Party conducting such filing and procuring in a country,
the Filing Party with respect to
such country), provided that if a
Party is a Manufacturer of an Antibody Product, then such party shall be the
Filing Party with respect to submissions and communications governed by this
Article 5 with respect to such Manufacture and in any event the Manufacturing
Coordinator and the Manufacturer, as applicable, shall provide the other Party
or Parties (as the case may be) all such chemistry, manufacturing and controls
material and such other data (or a drug master file or equivalent outside the
United States containing the same) and grant each Party such rights of
reference as are in each case necessary to obtain and maintain such INDs, Drug
Approval Applications and Regulatory Approvals as set forth in Article
7.5.  Notwithstanding the foregoing, each
Party’s obligation to obtain Regulatory Approvals shall be limited as set out
in Articles 2.1(a)(ii) and 2.1(a)(iii) (as applicable) unless otherwise agreed
in writing by the Parties.  For clarity,
as set forth in Article 8.2 and 8.4(a), the Continuing Party shall, except
where the Manufacturer is the Filing Party as set out above, be the Filing
Party with respect to an Antibody Product for an Independent Indication for
which it is the Continuing Party (i) for an IND throughout the Territory, and
(ii) for a Drug Approval Application in the Territory for which it is the
Territorial Lead.


 


(c)                                   The Filing Party shall comply with all
Applicable Law relevant to its responsibilities pursuant to Articles 5.1(a) and
(b).  The Filing Party shall use [***]
[Confidential Treatment Required] to perform the activities contemplated under
this Agreement, with the oversight of the JDT and in accordance with the
Development Plan for the Agreed Indications. 
Prior to submitting an IND, Drug Approval Application or other document
in support of a Regulatory Approval for an Antibody Product for an Agreed
Indication, the Parties, through the JDT, shall consult and cooperate in
preparing such filings.  Each Party shall
have the right to review and comment on all INDs, Drug Approval Applications
and other documents in support of a Regulatory Approval for an Antibody Product
for an Agreed Indication in accordance with specific timelines or other
arrangements agreed upon by the JDT, and no such filing for an Antibody Product
for an Agreed Indication shall be made unless the JDT has approved the form and
content of such filing.  With respect to
an Antibody Product for an Independent Indication, the Continuing Party for
such Independent Indication shall, subject to Article 2.1(d), control the
scope, content and timing of filing of INDs, Drug Approval Applications and
other documents in support of Regulatory Approvals with respect to Antibody
Products in such Independent Indication in accordance with Article 8. Unless
otherwise required by relevant Regulatory Authorities, this Agreement or
Applicable Law, all regulatory documents shall be held by the Filing Party at a
site of its selection and the Filing Party shall provide the other Party with a
duplicate set of such regulatory documents to be held by the other Party at a
site of the other Party’s own selection. 
Unless otherwise agreed by the JDT and subject to the terms of this
Agreement, the Filing Party shall own all regulatory submissions, including all
INDs, Drug Approval


 


37





















 


Applications, Regulatory Approvals and other
government licences, approvals and certificates for Antibody Products in the
applicable jurisdiction.  For an Antibody
Product for an Independent Indication, where the Filing Party is operating in a
country where it is not the Territorial Lead, the Territorial Lead shall
provide all reasonable cooperation and assistance to the Filing Party with
respect to such regulatory submissions.


 


(d)                                 Except as otherwise
expressly provided in this Agreement, without the prior written approval of the
Collaboration Committee, the Filing Party shall not transfer title or otherwise
dispose of or grant any rights or interests, including any rights of reference,
in or to, any INDs, Drug Approval Applications, Regulatory Approvals or other
government licences, approvals or certificates for an Antibody Product in the
Territory, or otherwise impair the other Party’s rights in such INDs, Drug
Approval Applications, Regulatory Approvals or other government licences,
approvals or certificates.


 


(e)                                  Within a reasonable
time prior to filing, the Filing Party shall provide the other Party with a
copy of all documents or reports to be filed with the FDA or any other
Regulatory Authority under this Agreement (or, if not feasible, the Filing
Party shall provide the other Party with on-site or electronic access to such
documents or reports, with reasonable advance written notice of the
availability of each such document or report), including with respect to any
IND, Drug Approval Application, Regulatory Approval or other government
licence, approval or certificate for an Antibody Product, and any data packages
in support thereof.  The JDT for Agreed
Indications, and the Continuing Party for an Independent Indication, shall
approve the form and content of all such documents or reports prior to
filing.  Other communications and
interactions of either Party with Regulatory Authorities related to Antibody
Products shall be subject to the terms of Article 5.4.


 


(f)                                    The content and
language of the proposed Product Labelling, and all changes to it, including
all safety-related package insert changes for Antibody Products shall be
prepared by the JDT for Agreed Indications and by the Continuing Party, in
consultation with the JDT, for any Independent Indication, and shall be
approved by the Collaboration Committee prior to submission to the applicable
Regulatory Authority.


 


(g)                                 Nothing in this
Article 5.1 is intended or shall be construed to prevent or delay a Party or
its Affiliates from making any filing with or submission to, or responding to
requests from, or complying with any requirements of, the Regulatory
Authorities in the Territory as required by Applicable Law, provided that such Party or its Affiliates
used [***] [Confidential Treatment Required], as appropriate in such
circumstances, to comply with the foregoing provisions of this Article 5.1.


 


(h)                                 Notwithstanding
anything to the contrary in this Agreement, and subject to the terms of Article
11, the Filing Party shall have the right to receive from the other Party (and
the other Party shall provide to the Filing Party) any regulatory data or
Information Controlled by the other Party related to an Antibody Product, which
the Filing Party, as the holder of any IND, Drug Approval Application,
Regulatory Approval or other government licences,


 


38





















 


approvals or certificates in the applicable jurisdiction, is required to
have by Applicable Law, or to which a Regulatory Authority having jurisdiction
wishes to have access, or which the Filing Party reasonably requires in order
to carry out its responsibilities pursuant to this Agreement.


 


5.2                               Access to INDs and Drug Approval Applications


 


To the extent that it is reasonably possible to
do so, each Filing Party shall (a) in relation to Agreed Indications, grant the
other Party, and (b) in relation to Independent Indications, grant to the
Continuing Party, a right of access and reference to (and if permitted, name it
a party of record on) all INDs, Drug Approval Applications, Regulatory
Approvals and other government licences, approvals or certificates and shall
promptly notify Regulatory Authorities of (and as soon as is reasonably
practicable after such notification take all actions reasonably necessary to
effect or evidence) the other Party’s right of access and reference to (and if
permitted, naming the other Party as a party of record on) such INDs, Drug
Approval Applications, Regulatory Approvals and other government licences,
approvals or certificates.


 


5.3                               Adverse Event Reporting; Customer Complaints


 


(a)                                  Each Party shall
maintain a record of, and where required by Applicable Law follow-up on, all
non-medical and medical product-related complaints and reports of adverse
events that it receives with respect to any Antibody Product.  Each Party shall promptly notify the other
Party of any complaint or adverse event report received by it and shall provide
the other Party with a copy of such complaint or adverse event report as soon
as reasonably possible following initial receipt (and in any event no later
than (i) within [***] [Confidential Treatment Required] of initial receipt for
any complaint or adverse event report relating to death or life threatening
illness, or (ii) within [***] [Confidential Treatment Required] of initial
receipt for any other complaint or adverse event report, or, in each case, such
shorter period as may be required to comply with Applicable Law).


 


(b)                                 The Filing Party
shall be responsible for reporting to Regulatory Authorities any adverse events
and safety issues for such Antibody Product, in compliance with the
requirements of Applicable Law, and shall simultaneously provide the other
Party with a copy of such report.  If
there is reasonably sufficient time available to do so, the Filing Party shall
give the other Party an opportunity to review, and the Parties shall consult
with each other, prior to submission of any such report.


 


(c)                                  As soon as
reasonably practicable, the Parties shall, through their pharmacovigilance
departments, meet, determine and adopt detailed procedures for the collection,
review, assessment, tracking and filing of Information related to complaints
and adverse events associated with Antibody Products and shall meet
periodically to update the procedures.


 


5.4                               Communications


 


(a)                                  In
addition to the responsibilities in Article 5.1, each Filing Party shall have
primary and, except as may be required by Applicable Law or requested by


 


39





















 


any Regulatory Authority, exclusive responsibility for all
correspondence and for any official communications with Regulatory Authorities
in the jurisdictions and for the Indications for which it is the Filing
Party.  Each Party shall reasonably
cooperate with the other Party regarding any direct communications with the
Regulatory Authorities.


 


(b)                                 Each of the Parties
shall have the right to (i) be present at all scheduled meetings with
Regulatory Authorities having jurisdiction in any part of the Territory, and
(ii) be present on all telephone calls with Regulatory Authorities having
jurisdiction in any part of the Territory where any matter which may affect its
activities or studies is to be discussed.


 


(c)                                  Except as may be
required by Applicable Law or requested by the Filing Party or any Regulatory
Authority having jurisdiction with respect to a country or matter, the other
Party shall not independently communicate regarding an Antibody Product with
any Regulatory Authority having jurisdiction with respect to such country or
matter.  The other Party shall keep the
Filing Party informed of any such required communications.


 


(d)                                 Regarding the
Manufacture of an Antibody Product, each of the Parties shall have the right
(and the Manufacturing Coordinator shall procure that the Manufacturer shall,
at the request of the Filing Party, have the obligation), to be present at all
meetings and on all telephone calls with, and at all inspections by, Regulatory
Authorities where issues regarding the Manufacturing of such Antibody Product
are to be discussed or where required by Applicable Law.


 


(e)                                  Each Party shall
promptly notify and provide the other Party with a copy of any correspondence
or other reports or complaints submitted to or received by the first Party from
any Regulatory Authority, other governmental authority, industry association or
other Third Party (i) claiming that any Promotional Materials or Promotional or
Detailing activities are inconsistent with the Product Labelling or are
otherwise in violation of any Applicable Law, or (ii) making any other claim or
assertion with regard to an Antibody Product that could be reasonably expected
to have an adverse effect on the Development, Commercialisation or Manufacture
of such Antibody Product in the Territory, including any communication with
respect to safety.


 


5.5                               Recalls


 


(a)                                  The Parties shall
exchange their internal standard operating procedures as to product recalls and
market withdrawals (SOPs)
reasonably promptly after the first filing of a Drug Approval Application for
an Antibody Product and thereafter reasonably promptly after any time such SOPs
are approved or modified.  In the event
that, in a country, a Party determines that an event, incident or circumstance
has occurred which may result in the need for a recall or market withdrawal or
stock recovery (collectively referred to as a Recall),
of Antibody Product or any lot(s) of Antibody Product, such Party shall promptly
notify the other Party in writing.


 


(b)                                 The Territorial
Lead in a country shall have the right to determine whether and upon what terms
and conditions to Recall an Antibody Product in such


 


40





















 


country.  Prior to making any
Recall decision, each Party shall consult with the other Party.  The Filing Party shall be responsible for
discussions with Regulatory Authorities within the applicable country regarding
all aspects of the Recall decision and the execution of any Recall.  Any costs or expenses of any Recall shall be
a Commercialisation Expense for the applicable country for an Agreed Indication
and shall be borne by the Continuing Party with respect to an Independent
Indication, provided that, to the
extent that such Recall with respect to an Agreed Indication or an Independent
Indication is caused by or results from the negligence or wilful misconduct of
a Party, its Affiliates or permitted sublicensees or Distributors, or their
respective directors, officers, employees or agents, [***] [Confidential
Treatment Required].  UCB and ImClone
shall each maintain complete and accurate records of any Recall it has the
right to control pursuant to this Article 5.5 for such periods as may be
required by legal requirements, but in any event for no less than [***]
[Confidential Treatment Required].


 


5.6                               Applications for Regulatory Exclusivity


 


The Parties recognise that exclusivity rights
granted or provided for under Applicable Law may be commercially significant to
Antibody Products.  To the extent
permitted by such Applicable Law, as between the Parties, the Territorial Lead
for a country with respect to Agreed Indications and the Continuing Party for
an Independent Indication shall have the exclusive right to file for, request
and maintain any regulatory exclusivity rights for Antibody Product in such
country (including data and marketing exclusivity rights, regulatory
exclusivity rights based upon an orphan drug designation of an Antibody Product
for an Agreed Indication or Independent Indication and exclusivity following
submission of pediatric study data) and to conduct and prosecute any
proceedings or actions to enforce such regulatory exclusivity rights in
countries for which it is the Territorial Lead. 
For the avoidance of doubt, any costs incurred by the Parties in
obtaining, maintaining or enforcing such exclusivity rights shall be treated as
Development Costs, except to the extent that such costs relate solely to an
Independent Indication (with respect to Development or Post-Approval Studies,
in the Territory and with respect to Commercialisation (except Post-Approval
Studies), in the countries for which the Continuing Party is the Territorial
Lead) [***] [Confidential Treatment Required].


 


6.                                      COMMERCIALISATION OF ANTIBODY PRODUCTS


 


6.1                               Territorial Lead


 


(a)                                  The Territorial
Lead shall use [***] [Confidential Treatment Required]to maximise the Operating
Profit of each Antibody Product for Agreed Indications in the countries for
which it is the Territorial Lead.


 


(b)                                 The Territorial
Lead shall be responsible for the selection, appointment and management of the
sublicensees and Distributors in the countries for which it is the Territorial
Lead in accordance with the provisions of Article 6.2.


 


41





















 


6.2                               Distributors and Co-Promotion


 


(a)                                  Subject to Articles
6.2(b) and Article 9.5, a Territorial Lead may appoint Distributors or
Co-Promotion partners in any country for which it is the Territorial Lead,
subject to first obtaining the agreement of the other Party, [***]
[Confidential Treatment Required]


 


(b)                                 Prior to appointing
any Third Party as a Distributor or to Co-Promote an Antibody Product in any
country for which it is the Territorial Lead, the Territorial Lead shall give
the other Party written notice of its intention to do so (such notice to
include a description, in reasonable detail, of the nature and scope of the
relevant Distributor or Co-Promotion activity) and shall give the other Party
the right of first refusal to undertake that Distributor or Co-Promotion
activity itself.  Within [***]
[Confidential Treatment Required] of receipt of such notice, the other Party
shall, by notice in writing to the Territorial Lead, either:  (i) elect not to undertake that Distributor
or Co-Promotion activity, in which case the Territorial Lead may proceed with
the appointment of the Third Party to undertake that Distributor or
Co-Promotion activity pursuant to Article 6.2(a), provided that the Territorial Lead shall not permit the
appointed Third Party to undertake any Distributor or Co-Promotion activity
that falls outside the description of the nature and scope of the Distributor
or Co-Promotion activity that was included with such notice; or (ii) elect to
undertake that Distributor or Co-Promotion activity, in which case the other
Party shall be entitled to undertake that Distributor or Co-Promotion activity
under the direction of the Territorial Lead and in accordance with the terms of
this Agreement, with all [***] [Confidential Treatment Required] costs and
expenses incurred by the other Party in undertaking that Distributor or
Co-Promotion activity being treated as [***] [Confidential Treatment Required]
and Loss except to the extent that such costs and expenses relate solely to an
Independent Indication in which case such costs shall be borne by the
applicable Continuing Party unless and until such Independent Indication is
converted into a Converted Agreed Indication, whereupon the Non-Continuing
Party shall reimburse the Continuing Party for such costs as provided in
Article 8.9.  If the other Party fails to
respond to any written notice of the Territorial Lead’s intention to appoint a
Third Party to undertake any Distributor or Co-Promotion arrangement within the
required [***] [Confidential Treatment Required] period, the other Party will
be deemed to have elected not to undertake that Distributor or Co-Promotion
activity.


 


6.3                               Establishment of Joint Commercialisation Team


 


No later than [***] [Confidential Treatment Required]
before the anticipated date of the first Regulatory Approval, or earlier if
agreed by the Collaboration Committee, the Parties shall establish a Joint
Commercialisation Team (JCT) to facilitate the Commercialisation of Antibody
Products on a global basis.


 


(a)                                  JCT
Members


 


The JCT shall consist of up to [***] [Confidential Treatment Required]
representatives of each Party.  Each
member of the JCT shall be an individual with operational experience in the Commercialisation
and marketing of


 


42





















 


pharmaceutical products.  The
Development Team Leader for each Party may also be one of the representatives
for such Party on the JCT.  One
representative from each Party on the JCT shall be designated as that Party’s Commercialisation Team Leader to act as the
primary JCT contact for that Party. 
Together, the Commercialisation Team Leaders will be jointly responsible
for managing the JCT.  Each Party’s
Commercialisation Team Leader shall be responsible for ensuring that his/her
Party carries out the activities assigned to such Party under the
Commercialisation Plan.  Either Party may
replace any or all of its representatives on the JCT at any time upon written
notice to the other Party.  Any member of
the JCT may designate a substitute with suitable experience to attend and
perform the functions of that member at any meeting of the JCT.  Each Party may invite (at its discretion and
with the consent of the other Party, [***] [Confidential Treatment Required]
additional employees or consultants to attend JCT meetings.  The JCT shall meet at least [***]
[Confidential Treatment Required], or more frequently as agreed by the
JCT.  The location of regularly scheduled
JCT meetings shall alternate between the offices of the Parties unless
otherwise agreed.  Meetings may be held
by videoconference or telephonically. 
Meetings shall be chaired by a single JCT representative of one of the
Parties, with the Party responsible for designating the chairperson alternating
each Contract Year.  The Collaboration
Committee shall decide which Party will be responsible for designating the
chairperson for the Contract Year in which the JCT is established.  The Party that does not provide the
chairperson shall designate a member of the JCT to record, in sufficient
detail, minutes of the discussions and decisions of the JCT.  Such minutes shall be circulated to the
Parties promptly following the meeting for review, comment and, after approval
from [***] [Confidential Treatment Required], distribution.  The Parties shall endeavour to manage the
business and meetings of the JCT in the most cost-effective way possible.


 


(b)                                 Responsibilities
of the JCT


 


The JCT shall, during the Development of an Antibody Product, coordinate
with the JDT and the JMT those activities deemed necessary for successful
Commercialisation of Antibody Product for Agreed Indications in the Territory
upon Regulatory Approval.  The JCT shall
be responsible for preparing the Commercialisation Plan and the
Commercialisation Budget (and recommending updates and amendments to the
Commercialisation Plan and Commercialisation Budget as necessary) as further
set forth in Articles 6.5 and 6.8, and for overseeing and implementing the
activities contemplated under the Commercialisation Plan and under the other
relevant portions of this Article 6. The JCT shall also coordinate with the JDT
in developing and implementing standard operating procedures for adverse event
reporting and compliance with regulatory requirements in the Territory, consistent
with Article 5.  The JCT shall provide
Quarterly reports to the Collaboration Committee of its activities.


 


(c)                                  JCT
Decision-Making


 


Decisions of the JCT shall be made by [***] [Confidential Treatment
Required].  If the JCT is unable to
resolve a dispute regarding any issue, the


 


43





















 


matter shall be resolved pursuant to the dispute resolution process set
forth in Article 15.


 


(d)                                 Annual
Production Requirements


 


The JCT shall be responsible for preparing and submitting to the
Collaboration Committee annual commercial production requirement reports with
respect to each Antibody Product as part of each annual recommended update to
the Commercialisation Plan.  Such report
shall include a non-binding forecast of requirements for Commercial Supplies of
Antibody Products for the Territory for the then current year and the following
[***] [Confidential Treatment Required] and any other related information that
the JCT determines to include.


 


6.4                               JCT and Territorial Lead Responsibilities


 


(a)                                  Each Territorial
Lead has the right and responsibility to Commercialise Antibody Products in the
manner it deems appropriate, but subject always to its obligations under this
Agreement including those set out in Articles 2.1 and 8 and this Article
6.  The Territorial Lead shall book all
sales of Antibody Products in the countries for which it is the Territorial
Lead.  If the JCT determines that any
Commercialisation activities for Antibody Products should be conducted jointly
or on a coordinated basis between the Parties, such activities shall be
coordinated through the JCT.  The Parties
now agree that, in addition to those matters set forth in Article 6.3(b), it is
likely they will wish to coordinate the following matters, and that unless and
until the Parties determine otherwise, and subject always to Articles 6.3(c)
and 3.7, the JCT shall be responsible for:


 


(i)                                     addressing
strategic issues with relevance to Antibody Products for Agreed Indications
throughout the Territory (e.g., branding, pricing, reimbursement issues,
regulatory issues, product positioning) and consulting with the Continuing
Party with respect to such issues for its Independent Indications, and making
recommendations to the Collaboration Committee for approval with respect to
product positioning, pricing and reimbursement issues for all Antibody
Products;


 


(ii)                                  deciding
any activities that the Parties shall undertake jointly in order to
Commercialise Antibody Products for Agreed Indications on a world-wide basis
(e.g., pre-launch activities, market research, launch, post—launch
marketing, Promotion, education, developing Promotional Materials,
participation in congresses and publications) (collectively, the Joint Activities);


 


(iii)                               coordinating,
reviewing and commenting on Post-Approval Studies for Antibody Products, provided that, subject to Article 4.7(e), each Party shall
have the right to pursue Post-Approval Studies in the Territory in support of
Compendia Listings in the countries for which it is the Territorial Lead;


 


44





















 


(iv)                              assisting
the JDT with the preparation of recommendations to the Collaboration Committee
with respect to the packaging, labelling and language to be included in the
Product Labelling of all Antibody Products;


 


(v)                                 coordinating
commercial manufacturing production requirements of Antibody Products;


 


(vi)                              in
consultation with the JPC, selecting, and recommending to the Collaboration
Committee for approval, Product Trademarks and generic names for Antibody
Products;


 


(vii)                           developing
and updating a Commercialisation Plan for each Antibody Product pursuant to
Article 6.5;


 


(viii)                        developing
and approving a publication and scientific symposia strategy and a calendar of
key scientific and clinical meetings at which the Parties will seek to present
the results of Clinical Studies for the Antibody Product for Agreed
Indications; and


 


(ix)                                resolving
any complaint by a Party that the Development, Commercialisation or
Manufacturing activities of the other Party are adversely affecting the
Commercialisation of Antibody Products in the countries for which the Party
making the complaint is the Territorial Lead.


 


(b)                                 Subject to Articles
2.1, 3.7, 6.4(a), 6.7 and 8, the Territorial
Lead shall be responsible for the Commercialisation of Antibody Products in the
countries for which it is the Territorial Lead in a manner consistent with the
Commercialisation Plan, including:


 


(i)                                     tactical issues,
for example, sales force allocation and disposition;


 


(ii)                                  determining
Promotional Materials suitable for each such country in accordance with Article
6.12;


 


(iii)                               preparing
and implementing the Country Plan and monitoring the Commercialisation Budgets
and forecasts for each such country; and


 


(iv)                              booking
sales, taking orders, distributing, handling returns, and contracting and
administering accounts.


 


6.5                               Commercialisation Plan


 


(a)                                  The JCT shall
develop, for approval by the Collaboration Committee, a Commercialisation Plan
for Antibody Products, which Commercialisation Plan shall:


 


(i)                                     outline the overall
strategy for the Commercialisation of Antibody Products throughout the
Territory, including the strategy for positioning of the Antibody Products;


 


45





















 


(ii)                                  identify
manufacturing needs and requirements of Commercial Supplies of Antibody
Products and identify an appropriate forecasting mechanism to provide the
Manufacturer with sufficient lead-time to Manufacture and to supply the
Parties’ requirements of Commercial Supplies of Antibody Products;


 


(iii)                               identify
Joint Activities; and


 


(iv)                              address
any other issue where the Parties wish to adopt a coordinated approach
throughout the Territory.


 


(b)                                 A proposed initial
Commercialisation Plan for Antibody Products shall be developed and forwarded
by the JCT to the Collaboration Committee, and the Collaboration Committee
shall approve an initial Commercialisation Plan for Antibody Products no later
than [***] [Confidential Treatment Required] before a Party is expected to file
the first Drug Approval Application for an Antibody Product.  Thereafter, the JCT shall review the
Commercialisation Plan at least Quarterly, and shall make recommendations with
respect to any updates or amendments thereto to the Collaboration Committee.  Either Party may at any time propose an
amendment to the Commercialisation Plan. 
Any such recommendations with respect to Agreed Indications shall
include a good faith estimate of the budget for any such update or amendment,
including any changes in the existing Commercialisation Budget.  Each Party shall cooperate with the JCT in
preparing such estimated budget.  Subject
to Article 6.7(b), all updates or amendments to the Commercialisation Plan must
be approved by the Collaboration Committee or, if the Collaboration Committee
cannot reach agreement on an update or amendment, the dispute resolution
process set forth in Article 15.


 


6.6                               Country Plan


 


(a)                                  From and after the
date on which the first Commercialisation Plan is agreed, the Territorial Lead
for each of the United States, Europe and Japan and any other countries in
respect of which marketing approval for any Antibody Product is being sought,
shall develop and submit to the JCT no less than [***] [Confidential Treatment
Required] prior to the commencement of each Contract Year, a commercialisation
plan and budget (Country Plan) for
each Antibody Product in such country for the immediately following Contract
Year.  Each Country Plan shall set out
the work activities, including the number and position of Details for such
Antibody Product to be carried out in such country in such Contract Year, in a
manner consistent with the Commercialisation Plan and Commercialisation Budget,
but taking into account the specific circumstances appropriate to the Commercialisation
of Antibody Products in such country. 
The Country Plan shall be developed to a standard and timing consistent
with other products marketed by the Territorial Lead in that country.


 


(b)                                 If the
Commercialisation Plan is amended in accordance with Article 6.5(b) or the
Commercialisation Budget is amended in accordance with Article 6.8(b), each
Territorial Lead shall promptly amend the Country Plans relating to the
countries for which it is Territorial Lead to conform with such amended


 


46





















 


Commercialisation Plan and/or Commercialisation Budget and resubmit any
such amended Country Plans to the JCT.


 


(c)                                  Each Territorial
Lead may amend any such Country Plan at any time on no less than [***]
[Confidential Treatment Required] advance written notice to the JCT, provided that such Country Plan, as
amended, is consistent with the Commercialisation Plan and the
Commercialisation Budget.


 


(d)                                 Any Dispute
regarding whether or not a Country Plan is consistent with the
Commercialisation Plan or the Commercialisation Budget shall, at the request of
either Party, be determined by the JCT and thereafter in accordance with
Article 15.


 


6.7                               Implementation of Country Plan; Deviations


 


(a)                                  The Territorial
Lead shall Commercialise Antibody Products in each country for which it is the
Territorial Lead, in accordance with the Country Plan for such country; provided, however,
that neither Party shall undertake any activity that is inconsistent with the
Commercialisation Plan (except as provided in Article 6.7(b)) or with its
obligations under this Agreement including its obligation to use [***]
[Confidential Treatment Required]to Commercialise Antibody Product for Agreed
Indications in the countries for which it is the Territorial Lead.


 


(b)                                 Where time does not
permit amendment as provided in this Article 6, a Party may deviate from an
agreed Commercialisation Plan or Country Plan with the prior written consent of
the other Party’s Commercialisation Team Leader [***] [Confidential Treatment
Required]. Where one Party consents to a deviation from an agreed
Commercialisation Plan or Country Plan in accordance with this Article 6.7(b),
the other Party shall promptly brief the JCT on the reasons for the deviation
and on the course of action pursued.


 


6.8                               Commercialisation Budget


 


(a)                                  In conjunction with
the approval of the first Commercialisation Plan or, in any event, no later
than [***] [Confidential Treatment Required] after the first Commercialisation
Plan is agreed, and thereafter, no later than [***] [Confidential Treatment
Required] prior to the start of each subsequent Contract Year, each Party shall
prepare and submit to the other Party (via the JCT) a proposed budget for its
activities for the ensuing Contract Year, as set forth in the Commercialisation
Plan, in support of the Commercialisation of Antibody Products (other than for
Independent Indications for which it is the Continuing Party) in a format to be
agreed by the Parties, but which budget must include (i) line item
estimates of expected Reimbursable Commercial Costs and forecasted Net Receipts
(calculated as set out in Schedule 2) for the ensuing Contract Year for the
countries for which that Party is Territorial Lead; and (ii) in respect of any
Commercialisation activities which will not be completed in that Contract Year,
line item estimates of the total Reimbursable Commercial Costs required to
complete such Commercialisation activities in countries for which that Party is
Territorial Lead on an activity-by-activity basis (regardless of whether such
Reimbursable Commercial Costs will be


 


47





















 


incurred in that Contract Year or subsequent Contract Years).  The Collaboration Committee shall review,
revise and approve these budgets in relation to the first such budget within [***]
[Confidential Treatment Required] after receipt thereof and thereafter no later
than [***] [Confidential Treatment Required] prior to the commencement of each
Contract Year (each such approved budget, a Commercialisation
Budget).  Once approved, the
Collaboration Committee, upon recommendation of the JCT, shall modify the
Commercialisation Budget from time to time based upon changes in patent status,
new product launches by competitors, adverse drug reactions, the results of
clinical studies, changes in pricing and reimbursement regimes and other
unanticipated events.  If the
Commercialisation Plan is updated or amended by the Collaboration Committee
pursuant to Article 6.5(b) with respect to the then-current Contract Year, the
Parties shall prepare and submit proposals for any necessary amendments to the
Commercialisation Budget for such Contract Year within [***] [Confidential
Treatment Required] after such update or amendment to the Commercialisation
Plan and the Collaboration Committee shall approve any necessary amendments to
Commercialisation Budget for such Contract Year within [***] [Confidential
Treatment Required] after such update or amendment of the Commercialisation
Plan.


 


(b)                                 The JCT shall
review the Commercialisation Budget at least Quarterly, and shall make
recommendations with respect to any updates or amendments thereto to the
Collaboration Committee.  Either Party
may at any time propose an amendment to the Commercialisation Budget.  No update or amendment to the
Commercialisation Budget shall become effective unless it is approved by the
Collaboration Committee or, if the Collaboration Committee cannot reach
agreement on an update or amendment, the dispute resolution process set forth
in Article 15.


 


(c)                                  In any Contract
Year, each Party shall promptly inform the other Party upon such Party
determining that it is likely to overspend or underspend by more than [***]
[Confidential Treatment Required] its respective total Reimbursable Commercial
Costs for an activity set forth in the Commercialisation Budget for that
Contract Year.  If in any such Contract
Year a Party exceeds its budgeted costs and expenses by more than [***]
[Confidential Treatment Required] for an activity, the Party that has so
exceeded its budget shall provide to the JCT and to the Collaboration Committee
(if the matter is escalated to the Collaboration Committee because it cannot be
resolved by the JCT) a full explanation for exceeding the Commercialisation
Budget for such activity.  If and to the
extent that any such overspend was [***] [Confidential Treatment Required] of
the applicable Party, then, provided the applicable Party has promptly notified
the other Party of such overspend and used [***] [Confidential Treatment
Required] to mitigate the size of such overspend, such overspend shall be
included in Reimbursable Commercial Costs and used to calculate Operating
Profits and Losses, which shall be shared by the Parties as provided in Article
2.3(b).  In addition, the JCT or
Collaboration Committee (as applicable) may, by unanimous agreement and [***]
[Confidential Treatment Required], allow some or all of any other overspend to
be included in the Reimbursable Commercial Costs as it considers equitable under
the circumstances.  Where


 


48





















 


any Commercialisation Budget sets out a line item estimate for the total
Reimbursable Commercial Costs required to complete any activity which will not
be completed in that Contract Year:  (i)
the budgeted costs and expenses for that activity shall [***] [Confidential
Treatment Required] and (ii) any [***] [Confidential Treatment Required]
against such line item estimate shall be [***] [Confidential Treatment
Required] to the Commercialisation Budgets for [***] [Confidential Treatment
Required] in each case as necessary to reflect any reasonable acceleration or
delay in such activity.  To the extent
that the overspend is not included in Reimbursable Commercial Costs as provided
in this Article 6.8, the Party who has exceeded its budget by more than [***]
[Confidential Treatment Required] will be solely responsible for the overspend.


 


6.9                               Public Statements Regarding Antibody Product


 


Each Party shall be responsible for
disseminating accurate information regarding Antibody Products to its sales
representatives based on Product Labelling and Promotional Materials (and for
causing its Affiliates, sublicensees and Distributors to so disseminate such
accurate information).  In exercising
their rights pursuant to this Article 6, UCB and ImClone shall seek to prevent
claims or representations in respect of Antibody Products or the
characteristics of Antibody Products (e.g., safety or efficacy) being made by
or on behalf of it or its Affiliates, sublicensees or Distributors (by members
of its or their sales force or otherwise) which do not represent an accurate or
fairly balanced summary or explanation of the Product Labelling of the Antibody
Products in the country in question.


 


6.10                        Medical and Other Inquiries


 


Each Party shall be responsible for responding
to all medical questions or inquiries relating to Antibody Products sold in
countries for which it is the Territorial Lead. 
The Territorial Lead shall keep such records and make such reports as are
reasonably necessary to document such communications in compliance with all
Applicable Law.


 


6.11                        Compliance with Laws


 


(a)                                  Each Party shall,
and shall procure that its Affiliates shall, comply with all Applicable Law
with respect to the Commercialisation of Antibody Products.  Each Party shall, and shall procure that its
Affiliates shall, use [***] [Confidential Treatment Required] to, and shall use
[***] [Confidential Treatment Required] to cause each of their respective
employees, representatives, sublicensees, Distributors and agents to, do
nothing which it knows or reasonably should know would jeopardise the goodwill
or reputation of the other Party or any Antibody Product.


 


(b)                                 Notwithstanding
anything in this Agreement to the contrary, neither Party shall be required to
undertake any activity relating to the Commercialisation of Antibody Products
that it believes, in good faith, may violate Applicable Law.


 


(c)                                  Each Party shall in
all material respects conform its practices and procedures relating to
educating the medical community in the countries for which it is the
Territorial Lead with respect to Antibody Products to any applicable


 


49





















 


industry association regulations, policies and guidelines, as the same
may be amended from time to time, and shall comply with Applicable Law with
respect thereto.


 


6.12                        Promotional Materials and Activity


 


(a)                                  Except with respect
to Promotional Materials that are jointly developed by the Parties pursuant to
Article 6.4(a)(ii), each Party shall be responsible for preparing all
Promotional Materials used to support an Antibody Product for an Agreed
Indication for use in its Territory in consultation with the JCT.  All such Promotional Materials shall be
submitted to the JCT prior to use by either Party and prior to submission to
any Regulatory Authority for regulatory approval (if such approval is
required); provided that the
content of Promotional Materials, once submitted, need not be submitted again
prior to re-use unless the Product Labelling for such Antibody Product in such
Agreed Indication applicable to such Promotional Materials has been changed
since such prior submission date.  The
Parties shall[***] [Confidential Treatment Required]Promotional Materials
prepared for use to support an Antibody Product for an Agreed Indication and
the Parties shall make such[***] [Confidential Treatment Required].  A Continuing Party with respect to an
Antibody Product for an Independent Indication shall be responsible for preparing
all Promotional Materials used to support such Antibody Product for such
Independent Indication, in consultation with the JCT.  The development of all Promotional Materials
shall be consistent with the Commercialisation Plan and Applicable Law, and with
the approved Product Labelling.  Subject
to Article 5, the Filing Party for an Antibody Product for an Indication in a
country shall take the lead in obtaining any approvals from the Regulatory
Authorities in such country required for the use of any Promotional Materials
for such Indication in such country, and shall submit all applicable
Promotional Materials for such Indication to the Regulatory Authorities in such
country as required by Applicable Law. 
For the avoidance of doubt, a Party shall not be required to re-submit
any Promotional Materials to the JCT prior to use if the only changes made to
such Promotional Materials since the original submission to the JCT are changes
required by any Regulatory Authority. 
The Continuing Party with respect to an Antibody Product for an
Independent Indication shall [***] [Confidential Treatment Required] in any
Promotional Materials prepared by it or on its behalf for use to support such
Antibody Product for such Independent Indication.


 


(b)                                 All Promotional
Materials, packaging and Product Labelling used by either Party in connection
with Antibody Products in any country of the Territory shall contain (i) the
relevant Product Trademarks, (ii) a UCB Company Mark (or a Trademark of a UCB
Affiliate if directed by UCB) designated by UCB in the UCB Territory or an
ImClone Company Mark (or a Trademark of an ImClone Affiliate if directed by
ImClone) designated by ImClone in the ImClone Territory, and (iii) if required
by Applicable Law, the logo and corporate name of the Manufacturer ((i) to
(iii) collectively, the Markings).  To the extent possible, and subject to any
Applicable Law, the UCB Company Mark and the ImClone Company Mark (or any
Trademark of their respective Affiliates, as applicable) shall have equivalent
prominence on all Promotional


 


50





















 


Materials, packaging and Product Labelling used by either Party in
connection with Antibody Products for Agreed Indications.  The manner in which the Markings are to be
presented on Promotional Materials, packaging and Product Labelling for
Antibody Products shall be subject to prior review and approval by (A) UCB with
respect to a UCB Company Mark under paragraphs (ii) and, if applicable, (iii)
above and ImClone with respect to an ImClone Company Mark under paragraphs (ii)
and, if applicable, (iii) above, and (B) the JCT with respect to the Markings
under paragraph (i) above.


 


(c)                                  Prior to the use of
any of them, each Territorial Lead shall provide to the other Party, through the
JCT, a prototype of any Promotional Materials, packaging or Product Labelling
for Antibody Products for the purposes of the other Party’s review of the
manner in which its Corporate Mark and any Product Trademark is used on any of
the same.  The reviewing Party shall
notify the other Party within [***] [Confidential Treatment Required] after
delivery of such prototype, whether the reviewing Party approves or disapproves
of the manner of such use and, in the case of disapproval, the specific reasons
for such disapproval and an acceptable alternative.  In the event the reviewing Party fails to so
notify the other Party within such [***] [Confidential Treatment Required]
period, the reviewing Party shall be deemed to have approved of the manner of
such use.  In the event the reviewing
Party disapproves of the manner of such use and the Parties are unable to reach
agreement regarding the manner of such use, such dispute shall be resolved by
the Parties in accordance with Article 15, provided
[***] [Confidential Treatment Required].


 


(d)                                 Each Party shall
permit one or more authorised representatives of the other Party, on reasonable
prior notice, at reasonable intervals, during normal business hours to inspect
and examine from time to time Promotional Materials, packaging and Product
Labelling for Antibody Products and the use of such Promotional Materials,
packaging or Product Labelling.


 


(e)                                  Each Party shall
instruct its sales representatives to and shall use [***] [Confidential
Treatment Required] to train and monitor its sales representatives for Antibody
Products so that such sales representatives, (i) use only Promotional Materials
(without any addition, deletion or other modification) approved for use under
this Article 6.12 for the Promotion of such Antibody Products, (ii) limit
claims of efficacy and safety for any such Antibody Products to those that are
consistent with Applicable Law and with approved (by the appropriate Regulatory
Authority) promotional claims in Product Labelling and such Promotional Materials,
and not add, delete or otherwise modify claims of efficacy and safety in the
Promotion of such Antibody Products in any respect from those claims of
efficacy and safety that are contained in such approved Product Labelling and
Promotional Materials, and (iii) Commercialise such Antibody Products in
adherence with Applicable Law.


 


6.13                        Post-Regulatory Approval Activities


 


Subject to Articles 2.1, 3.7 and 6.11, each
Party shall have the right to conduct Post-Approval Studies, including studies
in support of Compendia Listings, for Antibody


 


51





















 


Products anywhere in the Territory.  The JCT shall coordinate all Post-Approval
Studies for Antibody Products and shall have the opportunity to review and
comment on any proposed Post-Approval Study for Antibody Products before its
implementation.  In addition, before the
implementation of the relevant Post-Approval Study, the JDT shall have the
opportunity to review all designs and protocols for Post-Approval Studies in
support of Compendia Listings for Antibody Products that have been submitted by
either Party pursuant to Article 4.7(e) and shall refer such protocols to the
Collaboration Committee (which shall also have the opportunity to review such
protocols before the implementation of the relevant Post-Approval Study).


 


6.14                        Product Trademarks


 


Subject to Article 6.12, each Party shall
Commercialise Antibody Products solely under the applicable Product Trademarks.


 


6.15                        ImClone Royalties


 


(a)                                  In partial consideration
of the licence rights granted by ImClone to UCB hereunder, UCB shall pay to
ImClone royalties on the terms and conditions set forth in this Article 6.15
and Article 2.3, which payments shall not be used to calculate Operating
Profits or Losses.


 


(b)                                 Subject to Article
6.15(c), UCB shall pay to ImClone royalties on all Net Sales of Antibody
Products (except sales of Antibody Product for an Independent Indication during
the applicable Royalty Term by the Continuing Party or its Affiliates or their
respective Distributors or sublicensees in those countries for which such
Continuing Party is the Territorial Lead) sold by either Party, their
Affiliates or their respective Distributors or sublicensees in the Territory at
a royalty rate equal to [***] [Confidential Treatment Required] (the ImClone Royalties).


 


(c)                                  ImClone’s right to
receive ImClone Royalties under this Article 6.15 shall commence in each
country in the Territory on the date of [***] [Confidential Treatment
Required](the Royalty Term).


 


(d)                                 Any ImClone
Royalties payable by UCB under this Article 6.15, together with any prior
ImClone Royalties deferred by operation of this sentence, that [***]
[Confidential Treatment Required] 
Nothing in this Article 6.15(d) is intended or shall be construed to
relieve UCB of its obligations to pay ImClone Royalties under this Article
6.15.


 


(e)                                  For clarity, any
royalties payable under the ImClone In-Licences (including the [***]
[Confidential Treatment Required]) shall [***] [Confidential Treatment
Required]


 


7.                                      MANUFACTURE AND SUPPLY


 


7.1                               Establishment of Joint Manufacturing Team


 


Within [***] [Confidential Treatment Required]
after the Effective Date, the Parties shall form a Joint Manufacturing Team
(JMT).  Each member of the JMT shall have
operational experience in the Manufacture of Antibodies.  The JMT shall consist of up


 


52





















 


to [***] [Confidential Treatment Required]
representatives of each Party.  One such
representative from each Party shall be designated as that Party’s Manufacturing Team Leader to act as the
primary JMT contact for that Party. 
Together, the Manufacturing Team Leaders will be jointly responsible for
managing the JMT.  Either Party may
replace any or all of its representatives at any time upon written notice to
the other Party.  Any member of the JMT
may designate a substitute to attend and perform the functions of that member
at any meeting of the JMT.  Each Party
may invite (at its discretion with the consent of the other Party[***] [Confidential
Treatment Required]) additional employees or consultants to attend the JMT
meetings.  The JMT shall be empowered to
create such sub-teams or subcommittees as it may deem appropriate or necessary.  Each such sub-team or subcommittee shall
report to the JMT, which shall have authority to approve or reject
recommendations or actions proposed, subject to the terms of this
Agreement.  No sub-team or subcommittee
shall have authority to make any decision binding upon the JMT or the
Parties.  The JMT shall meet, at least
once each Calendar Quarter, or more frequently, as agreed by the JMT.  To the extent that meetings are held in
person, the location of JMT meetings shall alternate between the offices of the
Parties unless otherwise agreed. 
Meetings shall be chaired by a single JMT representative of one of the
Parties, with the Party responsible for designating the chairperson alternating
each Contract Year and with UCB responsible for designating the chairperson for
the First Contract Year.  Meetings may be
held by videoconference or telephonically. 
The Party that does not provide the chairperson shall designate a member
of the JMT to record, in sufficient detail, minutes of the discussions and
decisions of the JMT.  Such minutes shall
be circulated to the Parties promptly following the meeting for review, comment
and, after approval from [***] [Confidential Treatment Required],
distribution.  The Parties shall
endeavour to manage the business and meetings of the JMT in the most
cost-effective way possible.


 


7.2                               JMT Responsibilities


 


The JMT shall have the following
responsibilities:


 


(a)                                  for each Antibody
Product, developing, for approval by the Collaboration Committee, a detailed
plan and budget for the Manufacture and supply of that Antibody Product (the Manufacturing Plan), including targets for
cost of goods, forecast mechanisms, scale-up strategies, Manufacturing
technologies to be employed and strategies for supply chain continuity
including, where applicable, back-up Manufacturing facilities;


 


(b)                                 for each Antibody
Product, selecting the Party that will coordinate the Manufacture and supply of
that Antibody Product (the Manufacturing
Coordinator);


 


(c)                                  for each Antibody
Product, selecting the Party(ies) or Third Party(ies) that will be responsible
for Manufacturing and supplying such Antibody Product or any intermediate
thereof (each Party or Third Party so selected being a Manufacturer, which term shall also include
any Third Party supplier under the supply agreements listed in Schedule 4).  In choosing the Manufacturer(s), the JMT
shall select the Party(ies) or Third Party(ies) that are likely to be best able
to meet Clinical Supply and/or Commercial Supply requirements for Antibody


 


53





















 


Products and offer a competitive manufacturing
solution based on the following criteria:


 


[***] [Confidential
Treatment Required]


 


Unless otherwise agreed by the Parties,
potential Manufacturers (including either of the Parties if they wish to be
appointed Manufacturer) shall be required to prepare detailed submissions
(either as part of a competitive tender or such other procedure as may be
agreed by the JMT) addressing these requirements for review by the JMT.  Any member of the JMT may require any of the
potential Manufacturers to answer additional due diligence questions.  Such submissions and due diligence shall be
reviewed and discussed by the JMT before any decision as to the identity of any
Manufacturer is taken by the JMT;


 


(d)                                 [***] [Confidential
Treatment Required], approving (i) the terms on which any Manufacturer (whether
a Party or a Third Party) is appointed to provide Clinical Supplies and/or
Commercial Supplies and (ii) any agreements with respect thereto (each a Manufacturing Agreement);


 


(e)                                  approving any
amendment or modification to, or waiver under (i) any Manufacturing Agreement
or (ii) any of the supply agreements listed in Schedule 4 in existence on the
Effective Date to the extent that such amendment, modification or waiver
relates to Antibody Products;


 


(f)                                    approving the use
of any new Manufacturing Know-How that will be used in the Manufacture of
Antibody Products;


 


(g)                                 agreeing on the
formulation of Antibody Products and the specifications for the Manufacture of
Antibody Products including the processes for production, purification and
testing (including quality control and assurance testing procedures) for such
Antibody Products (collectively, the Antibody
Product Specifications);


 


(h)                                 consulting with the
JCT and with the JDT, as applicable, to assist the JCT and JDT in identifying
manufacturing needs and requirements of Clinical Supplies (including placebo
and comparators) and Commercial Supplies of Antibody Products and, together
with the JDT and JCT, developing and implementing an appropriate forecasting
mechanism to provide any Manufacturer(s) with sufficient lead-time to
Manufacture or have Manufactured the Parties’ requirements of Clinical Supplies
(including placebo and comparators) and Commercial Supplies of Antibody
Products;


 


(i)                                     coordinating with
the JDT and JCT to approve rationing plans for Antibody Product in the event of
scarcity of supply in accordance with Article 7.10;


 


54





















 


(j)                                     in consultation
with the JCT and JDT, as applicable, periodically review and, as necessary,
revise the forecasting and order mechanisms to ensure the continuity and
adequacy of Clinical Supplies and Commercial Supplies of Antibody Products;


 


(k)                                  determining whether
or not the Parties, or if applicable the Manufacturing Coordinator, should take
action to enforce their or its rights against a Third Party supplier of
Antibody Products and if so, making all decisions relating to the conduct of
such action;


 


(l)                                     periodically, but,
unless otherwise agreed by the Parties, no less frequently than every [***]
[Confidential Treatment Required], reassessing using the process set forth in
Article 7.2(c) above whether the existing Manufacturer(s) of Antibody Products
continue to offer a competitive Manufacturing solution and, if not, selecting
new or additional Manufacturers or amend the Manufacturing Agreement(s) with
the existing Manufacturer(s) to include such competitive terms, as provided in
Article 7.2(a) through (e) above; and


 


(m)                               agreeing whether
any of the Third Party suppliers
under the supply agreements listed in Schedule 4 shall be requested to
Manufacture Antibody [***] [Confidential Treatment Required]


 


The JMT shall also be responsible for all other
activities assigned to it by the Collaboration Committee and shall provide the
Collaboration Committee with Quarterly reports of its activities.


 


7.3                               Joint Manufacturing Team Decision-Making


 


Decisions of the JMT shall be made by unanimous
vote of the Manufacturing Team Leaders. 
If the JMT is unable to resolve a dispute regarding any issue, the
matter shall be resolved pursuant to the dispute resolution process set forth
in Article 15, provided that if (i) any dispute relating to the selection of a
Manufacturer or the terms of any Manufacturing Agreement has not been resolved
following referral to the Parties’ respective Chief Executive Officers in
accordance with the dispute resolution process, or (ii) there is a material
issue with respect to the quality or sufficiency of supplies of Antibody
Product pursuant to any Manufacturing Agreement and the Parties are unable to
agree how to resolve such issue within [***] [Confidential Treatment Required]
from the date one Party notifies the other that a material issue has arisen,
notwithstanding any other provision in this Agreement to the contrary, each
Party shall be immediately entitled to make its own arrangements for the
relevant supply of Antibody Products for Phase III Clinical Studies or in
respect of Commercialisation of Antibody Products in the countries for which it
is the Territorial Lead in which event Article 7.12 shall apply.


 


7.4                               Role of the Manufacturing Coordinator


 


(a)                                  The Manufacturing
Coordinator shall:


 


(i)                                     be responsible for
the day to day implementation of the Manufacturing Plan and administration of
Manufacturing-related activities;


 


55





















 


(ii)                                  provide advice to
the JDT and JCT on provisions in the Development Plan and Commercialisation
Plan, respectively, that relate to the supply of Antibody Products to the Parties;


 


(iii)                               consult with the
JCT and JDT, as applicable, and assist the JCT and JDT in identifying
Manufacturing needs and requirements of Clinical Supplies (including placebo
and comparators) and Commercial Supplies of Antibody Products;


 


(iv)                              provide assistance
to the JMT in connection with the development and implementation of an
appropriate forecasting mechanism to provide any Manufacturer(s) with
sufficient lead-time to Manufacture or have Manufactured the Parties’
requirements of Clinical Supplies (including placebo and comparators) and
Commercial Supplies of Antibody Products;


 


(v)                                 based on the
criteria set out in Article 7.2(c) and when and in the form requested by the
JMT, provide the JMT with details of Third Parties capable of Manufacturing
each Antibody Product and provide such additional assistance as the JMT may
require in connection with verifying such capability and otherwise assessing
proposals submitted by such Third Parties;


 


(vi)                              at the JMT’s
request and in accordance with the JMT’s instructions, negotiate on behalf of
the Parties the terms of a draft Manufacturing Agreement with such Third Party
to be submitted and reviewed by the JMT, provided
that the Party that is not the Manufacturing Coordinator shall have the right
to participate and have an equal voice in any such negotiation, and provided, further, that if the JMT selects
the Manufacturing Coordinator to act as Manufacturer for any Antibody Product
the other Party shall negotiate the terms of such Manufacturing Agreement with
the Manufacturing Coordinator;


 


(vii)                           use [***]
[Confidential Treatment Required] to ensure that any draft Manufacturing
Agreement submitted to the JMT for approval complies with Article 7.8 and draw
to the JMT’s attention any aspect of any draft Manufacturing Agreement that
does not comply with Article 7.8;


 


(viii)                        supervise the performance of
any Third Party Manufacturer and report any breaches of the Manufacturing
Agreement to the JMT;


 


(ix)                                provide any
administrative assistance required by the JMT in connection with the
performance of the Manufacturing Agreement, including compilation of forecasts
and submission of orders;


 


(x)                                   take such action as
the JMT directs to enforce the Parties’ rights, for the benefit of both
Parties, against Third Party Manufacturers. 
Costs and recoveries of any such enforcement action by the Manufacturing
Coordinator shall be treated in accordance with Article 7.9;


 


(xi)                                have the
responsibilities set out in Article 7.5(b); and


 


56





















 


(xii)                             provide such other
assistance as the JMT may reasonably request.


 


(b)                                 The Manufacturing
Coordinator shall ensure that the Manufacture of Antibody Products does not
deviate from the agreed Manufacturing Plan in any material respect, unless it
has obtained the JMT’s prior written consent to such material deviation [***]
[Confidential Treatment Required]; provided,
however that, where time does not
permit, the Manufacturing Coordinator may deviate from the agreed Manufacturing
Plan with the prior written consent of the other Party’s Manufacturing Team
Leader [***] [Confidential Treatment Required]. Where the Party that is not the
Manufacturing Coordinator’s Manufacturing Team Leader consents to a deviation
from the agreed Manufacturing Plan in accordance with this Article 7.4(b), the
Manufacturing Coordinator shall promptly brief the JMT on the reasons for the
deviation and on the course of action pursued.


 


(c)                                  The Manufacturing
Coordinator shall have the responsibilities set out or referred to in this Article
7.4 but shall not be responsible for any other activities unless assigned to it
by the JMT and shall provide the JMT with detailed reports of its activities
monthly within [***] [Confidential Treatment Required] of the end of the
relevant calendar month or at such intervals as the JMT may agree.


 


7.5                               Regulatory Approvals


 


(a)                                  Without prejudice
to Article 5, if a Party is the Manufacturer, such Party shall be responsible
for obtaining all necessary Regulatory Approvals to perform its obligations
under this Article 7 and the Manufacturing Agreement and shall (i) provide the
other Party with all chemistry, manufacturing and controls data and such other
data and information with respect to the manufacture, holding, shipment and
testing of such Antibody Product (or a drug master file or equivalent outside
the United States containing the same) as are required by cGMP and other
Applicable Law or that are otherwise necessary for each Territorial Lead to
obtain and maintain all INDs, Drug Approval Applications and Regulatory
Approvals for the sale and use of such Antibody Product in each country in
respect of which it is the Territorial Lead; and (ii) grant to the other Party
a right of access and reference to all Regulatory Approvals or other government
licences, approvals or certificates relating to the Manufacture of an Antibody
Product and any drug master file relating to an Antibody Product.


 


(b)                                 Without prejudice
to Article 5, if a Third Party is the Manufacturer, the Manufacturing
Coordinator shall be responsible for ensuring that the Manufacturer:


 


(i)                                     obtains all
necessary Regulatory Approvals to perform its obligations under the
Manufacturing Agreement or any of the agreements listed in Schedule 4;


 


(ii)                                  provides each Party
with all chemistry, manufacturing and controls data and such other data and
information with respect to the manufacture, holding, shipment and testing of
such Antibody Product (or a drug master file or equivalent outside the United
States containing the same) as are required by cGMP and other Applicable Law or
are otherwise necessary


 


57





















 


for each Territorial Lead to obtain and
maintain all INDs, Drug Approval Applications and Regulatory Approvals for the
sale and use of such Antibody Product in each country in respect of which it is
the Territorial Lead; and


 


(iii)                               grants to each
Party a right of access and reference to all Regulatory Approvals or other
government licences, approvals or certificates relating to the Manufacture of
an Antibody Product and any drug master file relating to an Antibody Product.


 


7.6                               Transfer Price


 


The Transfer Price for Antibody Product shall
be calculated as defined in Schedule 2.


 


7.7                               Manufacturing


 


(a)                                  The Parties agree
that Clinical Supplies of CDP-791 required for Development through [***]
[Confidential Treatment Required].  If at
any time UCB becomes aware that these[***] [Confidential Treatment Required]
will not be sufficient to meet such Development supply needs, it shall promptly
notify the JMT.  For the avoidance of
doubt, the Parties expressly acknowledge that these [***] [Confidential
Treatment Required].


 


(b)                                 Unless otherwise
agreed by the Parties, any Manufacturing Agreement (with a Party or a Third
Party), shall include the terms set out in Article 7.8 and such other terms as
the JMT considers necessary or appropriate in the circumstances.


 


(c)                                  If the JMT selects
a Third Party to be the Manufacturer of Antibody Product, that Third Party and
both ImClone and UCB shall be parties to the Manufacturing Agreement unless
that would be impracticable or UCB or ImClone, as the case may be, elects not
to be a party.


 


(d)                                 Each Party shall
comply and operate in accordance with the terms of any Manufacturing Agreement
and [***] [Confidential Treatment Required] to which it is a party if and to
the extent that such agreements relate to the supply of Antibody Product up to
and including [***] [Confidential Treatment Required]; provided, however,
that nothing shall require either Party to take any action in violation of
Applicable Law or refrain from taking any action if to do so would put it in
violation of Applicable Law.


 


(e)                                  Without prejudice
to UCB’s obligations pursuant to Article 4.1(a), UCB shall as soon as
practicable following the Effective Date and in any event within [***]
[Confidential Treatment Required] following the Effective Date, transfer in
aggregate [***] [Confidential Treatment Required] of master cell bank for
CDP-791 to one or more escrow agent(s). 
ImClone shall select the proposed escrow agent(s) and, subject to UCB’s
prior approval of the escrow agent so selected [***] [Confidential Treatment
Required] ImClone shall appoint the escrow agent(s).  Subject to Article 7.7(f), pending
release of all the vials to UCB or ImClone as set out in this Article 7.7(e),
UCB shall procure that there are in aggregate [***] [Confidential Treatment
Required] of master cell bank for CDP-791 in escrow with the appointed escrow
agent(s) at all times.  The costs


 


58





















 


incurred by the Parties in connection with the
appointment and services of the first escrow agent and any replacement(s) to
the first escrow agent agreed by the Parties shall be Other Out of Pocket
Expenses.  If, at ImClone’s discretion,
more than one escrow agent is appointed at any one time, the costs incurred in
connection with the appointment and services of any such additional escrow
agent(s) shall be borne by ImClone.  The
escrow agent(s) shall hold such vials on terms requiring that such vials shall
be released to ImClone (or as it may direct) at ImClone’s request provided that, subject to Article 7.7(f),
ImClone may only request such release if:


 


(i)                                     the Parties are
entitled to make their own arrangements for Manufacture of Antibody Product in
accordance with Article 7.3; or


 


(ii)                                  this Agreement is
terminated in accordance with Article 12 and ImClone is or will be the
Remaining Party, such transfer to be effected promptly following notice of
termination.


 


On termination of this Agreement in accordance
with Article 12 where UCB is the Remaining Party, ImClone shall instruct all
escrow agent(s) holding any vials of master cell bank for CDP-791 to return
such vials to UCB.


 


(f)                                    At any time during
the Term while vials of master cell bank for CDP-791 are held in escrow,
ImClone shall, at UCB’s request, instruct the escrow agent(s) to release up to
an aggregate of [***] [Confidential Treatment Required] to UCB.  Following any such release, UCB shall
transfer the same number of vials of master cell bank for CDP-791 back to the
releasing escrow agent(s) as soon as reasonably practicable.


 


(g)                                 At any time after
release of the vials from escrow to ImClone in accordance with Article 7.7(e),
UCB shall, at ImClone’s request, transfer to ImClone up to [***] [Confidential
Treatment Required]of master cell bank for CDP-791.  Following any such transfer, ImClone shall
transfer the same number of vials of master cell bank for CDP-791 back to UCB
as soon as reasonably practicable.


 


7.8                               Manufacturing Terms


 


(a)                                  The Manufacturing
Agreement shall provide sufficient time for renewal or termination to enable
the Parties to identify and qualify a suitable substitute Manufacturer that is
able to meet the Parties’ Clinical Supply and Commercial Supply requirements,
as applicable.  The Manufacturing
Agreement shall provide for appropriate strategies to ensure the continuity of
supply, including inventory management plans and, where [***] [Confidential
Treatment Required], qualified back-up manufacturing facilities.  The Manufacturer shall (i) transfer all
Information and Materials, including any proprietary know-how and any research
and master cell banks, and provide such technical assistance, and (ii) provide
any rights and licences, including any rights of reference to any Regulatory Approvals
and licences to any Patent Rights controlled by the Manufacturer, in each case
((i) and (ii)) to any substitute and back-up Manufacturers designated by the
JMT or, in the case of a breach of a Manufacturing Agreement by a Party
Manufacturer, the other Party, as [***]


 


59





















 


[Confidential Treatment Required] for such
substitute or back-up Manufacturer to Manufacture the applicable Antibody
Products.


 


(b)                                 Each Party shall
have a licence and right to use and reference any Manufacturing-related
Information, inventions or Materials characterised, conceived, developed,
derived, discovered, generated, identified or otherwise made by any employee,
consultant or agent of the Manufacturer in connection with any Manufacturing
activities conducted under a Manufacturing Agreement or the existing supply
agreements listed in Schedule 4 (Manufacturing
Know How) and any Patent rights with respect thereto (Manufacturing Patents) to Develop,
Commercialise, Manufacture, make, have made, use, sell, have sold, offer to
sell or resell, import, export, distribute or otherwise transfer physical
possession of or otherwise transfer title in or to Antibody Products.


 


(c)                                  The Manufacturer
shall be required to obtain and maintain all Regulatory Approvals relating to
the Manufacture of Antibody Product and grant access and rights of reference to
all such Regulatory Approvals and drug master files and other data as set forth
in Article 7.5.


 


(d)                                 The Manufacturer
shall manufacture Antibody Products in facilities described in the applicable
Regulatory Approvals in accordance with (i) the Antibody Product
Specifications, (ii) GMP and all other Applicable Law, and (iii) the terms of
the applicable Manufacturing Agreement ((i)-(iii) collectively, the Antibody Product Standards).


 


(e)                                  The terms of the
Manufacturing Agreement shall be consistent with and provide for the
Manufacture of Antibody Products as required and anticipated by this Agreement.


 


(f)                                    The Manufacturer
shall not manufacture for, or sell, licence, or distribute Antibody Products
to, any person or entity other than the Parties, their Affiliates or, if it has
received the relevant Party’s consent, a Party’s permitted sublicensees or
Distributors.


 


(g)                                 The Manufacturing
Agreement shall include a forecasting and order mechanism consistent with the
procedures adopted by the JDT, JCT and JMT pursuant to Articles 4.6(b)(viii),
6.5(a)(ii) and 7.2(a) that is designed to ensure that the Manufacturer is able
to meet the Parties’ clinical and commercial requirements on a timely basis,
which shall provide adequate flexibility to meet unexpected demand, or the lack
thereof, particularly around launch.


 


(h)                                 Manufacturer shall
guarantee, at the time of delivery, that Antibody Products supplied by it (i)
have been manufactured, packaged, held and shipped in accordance with the
Antibody Product Standards and all other Applicable Law; (ii) are not
adulterated or misbranded under the FFDCA, or under any other Applicable Law;
(iii) may be introduced into interstate commerce pursuant to the FFDCA; and
(iv) that the processes, procedures and materials used in the manufacture of
such Antibody Products do not and will not infringe the intellectual property
or other proprietary rights of a Third Party. 
Manufacturer shall also warrant and covenant that Manufacturer has not
been debarred and is not subject to debarment and will not use in any capacity,
in connection with the


 


60





















 


services to be performed under the Manufacturing
Agreement, any person who has been debarred pursuant to section 306 of the
FFDCA, 21 U.S.C. § 335a, or who is the subject of a conviction described in
such section (or under any analogous provisions of Applicable Law outside the
United States).


 


(i)                                     Manufacturer shall
defend, indemnify and hold the Parties, their Affiliates and their respective
officers, directors, employees, agents and designees harmless from any and all
losses, damages, liabilities, costs and expenses (including [***] [Confidential
Treatment Required] attorneys fees and other costs of defence), in connection
with any and all actions, suits, claims, demands or judgments that may be
brought or instituted against any of them by any Third Party to the extent that
any such losses, damages, liabilities, costs and expenses arise out of, or
result from, any [***] [Confidential Treatment Required]


 


(j)                                     The Parties shall
have the right (upon reasonable notice and during reasonable business hours) to
observe, audit and inspect the facility or the manufacturing process used in
the Manufacture of each Antibody Product, and Manufacturer will allow a
representative of the Parties (or, with respect to a Party Manufacturer, a
representative of the other Party) reasonable access to all Manufacturing
records for each such Antibody Product, so as to verify that Manufacturer is in
compliance with the Antibody Product Standards and all other Applicable
Law.  Manufacturer shall use [***]
[Confidential Treatment Required] to correct any material non-compliance with
the Antibody Product Standards or other Applicable Laws that is discovered and
brought to its attention as a result of such inspections. If only one Party
conducts such audit, the results shall be provided to the other Party.


 


(k)                                  If a Party is the
Manufacturer, the other Party shall have the right to audit Manufacturer’s
records relating to the calculation of the COGM and the Transfer Price in
accordance with Article 2.3(j).


 


7.9                               Costs


 


To the extent relating to Antibody Product,
except relating to a Party in its capacity as Manufacturer (which shall be
governed by Schedule 2 and the applicable Manufacturing Agreement), all [***]
[Confidential Treatment Required] including: [***] [Confidential Treatment
Required] shall be Development Costs if incurred for Development and Other Out
of Pocket Costs if incurred for Commercialisation, and all amounts recovered
from any Third Party supplier shall be deemed to be Gross Receipts, provided, however,
that if the [***] [Confidential Treatment Required] and provided further that any such[***]
[Confidential Treatment Required].


 


7.10                        Scarcity of Supply


 


If, at any time during the Term, there is an
insufficient supply of Antibody Products to meet both Parties’ needs for
Clinical Supplies and/or Commercial Supplies of that Antibody Product, the JMT
shall, in coordination with the JDT and/or JCT (as appropriate), allocate the
available Clinical Supplies and/or Commercial Supplies (as appropriate) of that
Antibody Product to the Parties [***] [Confidential Treatment Required] and
(ii) the goal of maximising the long term value of that Antibody Product for
both Parties.


 


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7.11                        Shared Risk of Third Party Suppliers


 


Each Party acknowledges that, save with respect
to any Third Party supplier with whom a Party has made its own arrangements for
the supply of Antibody Products pursuant to Article 7.3, the risk of non
performance by a Third Party supplier that Manufactures any Antibody Product is
a risk equally shared by them and that neither Party is responsible or liable
for any act or omission of any such Third Party supplier (other than an act or
omission to the extent caused by [***] [Confidential Treatment Required].


 


7.12                        Independent Manufacture


 


If the Parties elect to make their own
arrangements for the Manufacture of Antibody in accordance with Article 7.3:


 


(a)                                  each Party shall
provide [***] [Confidential Treatment Required] such assistance (including
providing prompt access to all ImClone Know How (in the case of ImClone), UCB
Know How (in the case of UCB) and Manufacturing Know How and rights of
reference to any Regulatory Approvals) as may be reasonably required by the
other Party to Manufacture or have Manufactured Antibody Product;


 


(b)                                 the provisions of
this Article 7 shall continue to apply in relation to Manufacturing activities
relating to supplies of Antibody Product for Phase I Clinical Studies and Phase
II Clinical Studies;


 


(c)                                  subject to Article
7.12(b), the responsibilities of the JMT shall be restricted to those set out
in Article 7.2(f) and (g) and unless the Parties otherwise agree there shall be
no Manufacturing Coordinator;


 


(d)                                 each Party shall
use [***] [Confidential Treatment Required] to secure a competitive
manufacturing solution based on the criteria set out in Article 7.2(c) and
shall consider such criteria in good faith when deciding whether to Manufacture
Antibody Product itself and when selecting any Third Party to Manufacture
Antibody Product;


 


(e)                                  each Party shall
use [***] [Confidential Treatment Required] to ensure that Antibody Product is
Manufactured in accordance with Article 7 as modified by this Article 7.12 and
the terms of any agreement it enters into with a Third Party for the
Manufacture of Antibody Product shall comply with Article 7.8 (to the extent
applicable when only one Party is a party to any such agreement) and shall also
use [***] [Confidential Treatment Required] to ensure that any such agreement
allows the assignment of such agreement to the Remaining Party on termination
of this Agreement;


 


(f)                                    Article 7.5 shall
continue to apply except that for the purposes of Article 7.5(b) each Party
shall assume the responsibilities of the Manufacturing Coordinator with respect
to any Third Party Manufacturer appointed by it;


 


(g)                                 each Party shall be
responsible for the Transfer Price of Antibody Product Manufactured by or on
behalf of that Party pursuant to this Article 7.12 and


 


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such costs shall not be included in the
calculation of Operating Profits and Losses; and


 


(h)                                 subject to Article
7.12(b), Article 7.10 shall not apply.


 


7.13                        Manufacturing Cost Allocation


 


(a)                                  If, as a result of any provision in any
of the existing supply agreements listed in Schedule 4, UCB or any of its
Affiliates is contractually obliged to use one of the Third Party suppliers
pursuant to that supply agreement for the supply of Antibody Products for any
Phase III Clinical Study or in respect of the Commercialisation of Antibody
Products (the Relevant Supply),
UCB agrees that, notwithstanding anything to the contrary in this Agreement,
UCB shall be solely responsible for the Additional Manufacturing Amount and UCB
shall reimburse ImClone with respect to the Additional Manufacturing Amount
through adjustments to the Operating Statement.


 


(b)                                 For the purposes of Article 7.13(a) and
Schedule 2, Additional Manufacturing Amount shall
mean the amount, if any, by which:


 


(i)                                     [***] [Confidential
Treatment Required]


 


(ii)                                  [***] [Confidential
Treatment Required]


 


8.                                      INDEPENDENT INDICATIONS


 


8.1                               Designation of Independent Indications


 


Each Party shall have the right at any time, on
written notice to the other Party, with respect to each Agreed Indication for
an Antibody Product to terminate its rights and obligations to continue to
Develop and Commercialise such Antibody Product for such Agreed Indication
(which Indication shall become an Independent
Indication, unless and until it is Converted pursuant to Article
8.9), whereupon, except as otherwise provided in this Article 8, such Party
(which Party shall be referred to herein as the Non-Continuing Party, and the other Party, the Continuing Party, with respect to such
Independent Indication for such Antibody Product):


 


(a)                                  shall cease to have
any right or, except as provided in Article 4.3(b), obligation to fund or
participate in the Development of such Antibody Product for such Independent
Indication in the Territory;


 


(b)                                 shall not have the
right to seek (including by filing a Drug Approval Application), obtain or maintain
any Regulatory Approvals for such Antibody Product for such Independent
Indication in the Territory; and


 


(c)                                  shall have no right
or obligation to share in any Operating Profits and Losses of the Continuing
Party with respect to such Antibody Product for such Independent Indication in
the countries for which the Continuing Party is the Territorial Lead except as
provided in Article 8.2(b) and 8.9 and, if the Non-Continuing Party is the
Manufacturer of such Antibody Product, pursuant to the applicable Manufacturing
Agreement.


 


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If, at any time, both Parties have exercised
their rights under this Article 8.1 with respect to an Agreed Indication, the
Parties shall cease all Development activities with respect to that Agreed
Indication as expeditiously and as cost effectively as possible with due regard
for patient safety and the rights of any subjects that are participants in
Clinical Studies or Post-Approval Studies and in compliance with Applicable Law.  All disputes regarding Independent
Indications shall be resolved pursuant to Article 15.


 


8.2                               Continuing Party’s Rights and Obligations with respect to an
Independent Indication


 


(a)                                  Subject to Article
8.3, the Continuing Party with respect to an Antibody Product for an
Independent Indication shall have the right to (i) conduct Development and
Post-Approval Studies of such Antibody Product for such Independent Indication
throughout the Territory, and the Non-Continuing Party shall assist the
Continuing Party with respect thereto pursuant to Article 8.8, and (ii) prepare
and file any Drug Approval Application, and obtain and maintain any Regulatory
Approvals, for such Antibody Product for such Independent Indication in the
countries for which it is the Territorial Lead and (iii) Commercialise such
Antibody Product for such Independent Indication in the countries for which it
is the Territorial Lead.  For clarity,
the foregoing does not permit the Continuing Party with respect to an Antibody
Product for an Independent Indication to Commercialise (other than to conduct
Post-Approval Studies for) such Antibody Product for such Independent
Indication in the countries for which the Non-Continuing Party is the
Territorial Lead.


 


(b)                                 The Continuing
Party with respect to an Antibody Product for an Independent Indication shall
pay to the Non-Continuing Party royalties on the Net Sales of such Antibody
Product for such Independent Indication, sold by the Continuing Party, its
Affiliates or their respective sublicensees or Distributors in the countries
for which the Continuing Party is the Territorial Lead (the Relevant Net Sales) as follows:


 


[***] [Confidential
Treatment Required]


 


(c)                                  [***] [Confidential
Treatment Required]


 


(d)                                 Article 2.3 shall
apply to all royalties due and owing under the provisions of this Article 8.2.


 


8.3                               Consultation with the JDT and Collaboration Committee


 


The Continuing Party, with respect to an
Antibody Product for an Independent Indication, shall consult regularly with
the JDT and consider in good faith the input of


 


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the JDT with respect to any decision or action
related to the Development of such Antibody Product for such Independent
Indication to the extent such decision or action could [***] [Confidential
Treatment Required] affect the Development of an Antibody Product for an Agreed
Indication or either Party’s ability to obtain and maintain Regulatory Approval
for an Antibody Product for an Agreed Indication or could give rise to material
safety concerns or other issues that might materially and adversely affect the
Development or Commercialisation of an Antibody Product for an Agreed
Indication.  In particular, the
Continuing Party shall submit all designs and protocols for Clinical Studies
for an Antibody Product for an Independent Indication to the JDT for review and
the Continuing Party shall not, unless otherwise agreed by the Collaboration
Committee, commence any such Clinical Study less than [***] [Confidential
Treatment Required] after such submission. 
Further, the Continuing Party with respect to an Antibody Product for an
Independent Indication, shall provide to the Collaboration Committee, for its
review and comment, but not approval:


 


(a)                                  within [***]
[Confidential Treatment Required]of any conversion of an Agreed Indication for
an Antibody Product to an Independent Indication in accordance with Article 8.1
or adoption of a new Indication as an Independent Indication in accordance with
Article 4.7(d) and thereafter at least [***] [Confidential Treatment Required]
prior to the start of each subsequent Contract Year, a plan setting out in
reasonable detail its proposed Development activities with respect to that
Antibody Product for the remainder of the Contract Year in which the conversion
or adoption occurs or the forthcoming Contract Year (as appropriate) such plan
to be attached to, but not form part of, the Development Plan;


 


(b)                                 upon the completion
of a Clinical Study, a summary of the Clinical Study results and any resultant
data analyses;


 


(c)                                  the annual reports
with respect to the Development of such Antibody Product for such Independent
Indication required pursuant to Article 4.6(e);


 


(d)                                 at least [***]
[Confidential Treatment Required] in advance of the expected filing date of a
Drug Approval Application for such Antibody Product for such Independent
Indication, a copy of such Drug Approval Application; and


 


(e)                                  promptly upon
becoming aware of such information, any other information relating to such
Independent Indication of which the Continuing Party is aware that is of
material commercial significance and which would be reasonably required by the
Non-Continuing Party in order to enable the Non-Continuing Party to make an
informed decision as to whether to exercise its option to Convert such
Independent Indication pursuant to Article 8.9.


 


In any case where any Antibody Product receives
Regulatory Approval for an Independent Indication, the Parties shall adopt a
mutually agreeable sales allocation methodology to distinguish sales of such
Antibody Product for such Independent Indication.


 


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8.4                               Regulatory Matters


 


(a)                                  Subject to Article
8.4(b), the Continuing Party with respect to an Antibody Product for an
Independent Indication shall be the Filing Party with respect to such Antibody
Product for such Independent Indication and shall be responsible for preparing
and filing any Drug Approval Application, and obtaining and maintaining any
Regulatory Approvals, for such Antibody Product for such Independent Indication
in the countries for which it is the Territorial Lead.


 


(b)                                 The Non-Continuing
Party with respect to an Independent Indication for an Antibody Product shall
use [***] [Confidential Treatment Required] to assign and transfer to the
Continuing Party all interest in and to all INDs and Regulatory Approvals to
such Antibody Product for such Independent Indication, and shall cooperate with
the Continuing Party [***] [Confidential Treatment Required] to effect such
assignments and transfers in an orderly fashion and shall provide to the
Continuing Party any copies of relevant documents and rights of reference and
access, including with respect to Agreed Indications, necessary to allow the
Continuing Party to exercise its rights under this Article 8, provided that, if (i) having used such
[***] [Confidential Treatment Required], the Non-Continuing Party is unable to
effect such assignments or (ii) the Continuing Party is unable to assume, or it
is impractical for the Continuing Party to assume, the responsibility of the
Filing Party for that Antibody Product for an Independent Indication, the
Non-Continuing Party shall continue to be the Filing Party in respect of that Antibody
Product and the Continuing Party shall reimburse the Non-Continuing Party in
respect of all [***] [Confidential Treatment Required] incurred by the
Non-Continuing Party in acting as Filing Party.


 


8.5                               Information and Materials


 


With respect to an Independent Indication for
an Antibody Product, the Non-Continuing Party shall promptly transfer to the
Continuing Party relevant Information and Materials as provided in Article
4.1(a).


 


8.6                               Transition for an Independent Indication


 


With respect to an Antibody Product for an
Independent Indication, the Non-Continuing Party shall [***] [Confidential
Treatment Required] transfer to the Continuing Party all Development and
Commercialisation and (to the extent applicable) Manufacturing activities in
the Independent Indication and the Collaboration Committee shall promptly meet
to devise a transfer plan providing for such transfer in a prompt, smooth,
orderly and cost-effective manner and both Parties shall effect such transfer
in accordance with such plan.  The
Development Plan, Development Budget, Commercialisation Plan and
Commercialisation Budget shall be amended to reflect any conversion of an
Agreed Indication to an Independent Indication.


 


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8.7                               Supply of Antibody Product


 


In relation to any Antibody Product for an Independent
Indication, the Continuing Party shall continue to be supplied with Clinical
Supplies and Commercial Supplies of such Antibody Product and, if applicable,
supplies of any comparator or placebo, [***] [Confidential Treatment Required]
to Develop and Commercialise such Antibody Product for such Independent
Indication under this Agreement as it would were such supplies for an Agreed
Indication and if the Continuing Party is not the Manufacturing Coordinator,
the Manufacturing Coordinator shall, subject to Article 7.10, continue to
coordinate the supply of Clinical Supplies and Commercial Supplies of that
Antibody Product to the Continuing Party as it would for an Antibody Product
for an Agreed Indication pursuant to Article 7.


 


8.8                               Assistance from Non-Continuing Party


 


In addition to its obligations with respect to
Independent Indications for which it is the Non-Continuing Party expressly set
out elsewhere in this Agreement, and as necessary in order to comply with
relevant Third Party obligations, including In-Licences and Manufacturing
Agreements, the Continuing Party may request that the Non-Continuing Party
takes such other actions in its own name in relation to the Development,
Manufacture and Commercialisation of an Antibody Product for an Independent
Indication and the Non-Continuing Party shall not [***] [Confidential Treatment
Required] refuse to take any such action requested by the Continuing
Party.  Save as expressly provided to the
contrary elsewhere in this Agreement, the Non-Continuing Party shall be
entitled to [***] [Confidential Treatment Required] in connection with
providing assistance, taking actions or supplying Materials with respect to
Antibody Products for Independent Indications (but only to the extent that (i)
this Agreement obliges them to provide such assistance, take such actions or
supply such Materials or (ii) the Continuing Party has requested the provision
of such assistance, taking of such actions or supply of such Materials).


 


8.9                               Conversion of Independent Indication to Agreed Indication


 


(a)                                  At any time during
the Term until [***] [Confidential Treatment Required]after an Antibody Product
for an Independent Indication has obtained Regulatory Approval for commercial
sale in any of the [***] [Confidential Treatment Required], the Non-Continuing
Party with respect to an Independent Indication for an Antibody Product shall
have the right, on written notice to the Continuing Party (an Option Exercise Notice), to convert such
Independent Indication for such Antibody Product into an Agreed Indication for
such Antibody Product (such conversion from an Independent Indication to an
Agreed Indication, a Conversion,
with Convert being given a
corresponding meaning).


 


(i)                                     In connection with
the potential exercise of any such Conversion, the Non-Continuing Party shall
have the right, on written notice to the Continuing Party, to request
additional information with respect to the applicable Independent Indication
for the applicable Antibody Product (an Information
Request), provided that
except as provided in Article 8.9(a)(ii), the Non-Continuing Party shall only
have the right to make such a request [***] [Confidential Treatment Required]
with respect to


 


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each Independent Indication for an Antibody Product.  Within [***] [Confidential Treatment
Required] of receipt of an Information Request with respect to a particular
Independent Indication for an Antibody Product, the Continuing Party shall provide
the Non-Continuing Party with (x) a statement of the Development Costs and
Reimbursable Commercial Costs incurred by the Continuing Party and its
Affiliates in, and that are specifically identifiable or [***] [Confidential
Treatment Required] allocable to, the Development and Commercialisation of such
Antibody Product for such Independent Indication from and after the date that
such Indication first became an Independent Indication pursuant to Article 8.1
or Article 4.7(d) [***] [Confidential Treatment Required] and (y) a Data
Package for such Antibody Product for such Independent Indication (to the
extent such information is available or [***] [Confidential Treatment Required]
by the Continuing Party), in each case to the end of the Calendar Quarter
occurring immediately before the date of the Information Request.


 


(ii)                                  The Non-Continuing
Party shall have the right to make an Information Request or, if applicable, an
additional Information Request, with respect to each Independent Indication for
an Antibody Product, if the Continuing Party with respect to such Independent
Indication fails, and upon written notice from the Non-Continuing Party
continues to fail for a period of not less than [***] [Confidential Treatment
Required], to use [***] [Confidential Treatment Required] to Develop or Commercialise,
as applicable, such Antibody Product for such Independent Indication (with any
Disputes with respect thereto resolved pursuant to the procedures set forth in
Article 15, [***] [Confidential Treatment Required]) and thereafter the
Non-Continuing Party shall have the right to Convert such Independent
Indication for such Antibody Product into an Agreed Indication (such
conversion, a Default Conversion)
by delivering to the Continuing Party an Option Exercise Notice in accordance
with Article 8.9(a) above (such Option Exercise Notice to specify that it is
with respect to a Default Conversion). [***] [Confidential Treatment Required].


 


(iii)                               If at any time
(regardless of whether any Information Request has been made by the
Non-Continuing Party) the Non-Continuing Party delivers an Option Exercise
Notice with respect to an Independent Indication for an Antibody Product
pursuant to Article 8.9(a) the remaining provisions of this Article 8.9 shall
apply.


 


(b)                                 The Continuing
Party shall within [***] [Confidential Treatment Required] of receipt of the
Option Exercise Notice with respect to an Independent Indication for an
Antibody Product, provide the Non-Continuing Party with an updated statement of
all of the Development Costs and Reimbursable Commercial Costs incurred by the
Continuing Party and its Affiliates in, and that are specifically identifiable
or [***] [Confidential Treatment Required] allocable to, the Development and
Commercialisation of such Antibody Product for such Independent Indication from
and after the date that such Indication first became an Independent Indication
pursuant to Article 4.7(d) or


 


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Article 8.1, as applicable, through the
effective date of the Option Exercise Notice with respect thereto, [***]
[Confidential Treatment Required], subject to audit in accordance with the
Article 8.9(e) (the Reimbursable Costs).


 


(c)                                  Subject to Article
8.9(e), following receipt of the updated statement described in Article 8.9(b)
with respect to the Conversion of an Independent Indication for an Antibody
Product, the Non-Continuing Party shall pay to the Continuing Party, in
accordance with Article 8.9(d), an amount (the Reimbursement Amount) equal to:


 


[***] [Confidential
Treatment Required]


 


(d)                                 Subject to Article
8.9(e), within [***] [Confidential Treatment Required]of receipt of the updated
statement described in Article 8.9(b) with respect to the Conversion of an
Independent Indication for an Antibody Product (the Initial  Payment Period),
the Non-Continuing Party shall pay to the Continuing Party a minimum of [***]
[Confidential Treatment Required]of the Reimbursement Amount.  If the Non-Continuing Party elects not to pay
the full Reimbursement Amount within the Initial Payment Period, the remainder
of the Reimbursement Amount shall be payable as follows:


 


[***] [Confidential
Treatment Required]


 


Interest calculated in accordance with Article
2.3(g) shall accrue on any unpaid portion of the Reimbursement Amount from the
[***] [Confidential Treatment Required] of the Initial Payment Period until
payment of the Reimbursement Amount in full. 
If the Non-Continuing Party elects not to pay such interest monthly it
will compound in accordance with Article 2.3(g).


 


(e)                                  The Non-Continuing
Party shall have the right, on written notice to the Continuing Party (such
notice to be provided within the [***] [Confidential Treatment Required] period
referred to in Article 8.9(d)), to have the Reimbursable Costs audited in
accordance with the procedures set forth in Article 2.3, and any adjusting
payments shall be calculated and paid in accordance with that Article.  For clarity, the Non-Continuing Party may not
serve notice to have the Reimbursable Costs audited after such [***]
[Confidential Treatment Required] period.


 


(f)                                    Upon payment by the
Non-Continuing Party to the Continuing Party of at least [***] [Confidential
Treatment Required] of the Reimbursement Amount in accordance with Article
8.9(d), such Independent Indication for such Antibody Product shall be deemed
to be Converted to an Agreed Indication (a Converted
Agreed Indication) for such Antibody Product for all purposes under
this Agreement, including with respect to Development Costs and


 


69





















 


Operating Profits and Losses, from and after
the effective date of the applicable Option Exercise Notice.


 


For clarity, the Non-Continuing Party shall not
have any right or obligation (other than to pay the Reimbursement Amount) to
share any Operating Profits and Losses attributable to a Converted Agreed
Indication for an Antibody Product [***] [Confidential Treatment Required].


 


9.                                      GRANT OF RIGHTS


 


9.1                               Patent and Know-How Licences


 


(a)                                  Subject to Article
9.1(c), UCB (on behalf of itself and its Affiliates) grants to ImClone a
licence and, subject in addition to Article 9.2, a sublicence (with respect to
Third Party rights Controlled by UCB) under the UCB Patent Rights, UCB
Know-How, Joint Patent Rights (to the extent Controlled by UCB), the
Manufacturing Know-How (to the extent Controlled by UCB), the Manufacturing
Patents (to the extent Controlled by UCB) and the Joint Know-How (to the extent
Controlled by UCB) to: (i) Develop Antibody Products for Agreed Indications in
the Field in the Territory; (ii) Commercialise, use, sell, have sold, offer to
sell, resell, import, export, distribute or otherwise transfer physical
possession of or otherwise transfer title in Antibody Products in the Field in
the ImClone Territory, provided
that ImClone and its permitted sublicensees shall have the right to conduct
Post-Approval Studies throughout the Territory; (iii) Develop Antibody Products
for Independent Indications for which ImClone is the Continuing Party in the
Field in the Territory, provided
that ImClone shall only have the right to file Drug Approval Applications for
such Independent Indications in the ImClone Territory; (iv) subject to Article
16.5, [***] [Confidential Treatment Required]; and (v) Manufacture Antibody
Products in the Territory as necessary or useful to: (A) exercise ImClone’s
rights under Article 9.1(a)(i) through (iv), and (B) if ImClone is a
Manufacturer, as necessary to satisfy ImClone’s obligations under this
Agreement and any Manufacturing Agreement to which it is a party; in each case
only in accordance with and subject to the terms of this Agreement.


 


(b)                                 Subject to Article
9.1(d), ImClone (on behalf of itself and its Affiliates) grants to UCB a
licence and, subject in addition to Article 9.2, a sublicence (with respect to
Third Party rights Controlled by ImClone) under the ImClone Patent Rights,
ImClone Know-How, Joint Patent Rights (to the extent Controlled by ImClone),
the Manufacturing Know-How (to the extent Controlled by ImClone), the
Manufacturing Patents (to the extent Controlled by ImClone) and the Joint
Know-How (to the extent Controlled by ImClone) to: (i) Develop Antibody
Products for Agreed Indications in the Field in the Territory; (ii)
Commercialise, use, sell, have sold, offer to sell, resell, import, export,
distribute or otherwise transfer physical possession of or otherwise transfer
title in Antibody Products in the Field in the UCB Territory, provided that UCB and its permitted
sublicensees shall have the right to conduct Post-Approval Studies throughout
the Territory; (iii) Develop Antibody Products for Independent Indications for
which UCB is the Continuing Party in the Field in the Territory, provided that UCB shall only have the
right to file Drug Approval Applications for such Independent Indications in
the UCB Territory;


 


70





















 


(iv) subject to Article 16.5, [***]
[Confidential Treatment Required]; and (v) Manufacture Antibody Products in the
Territory as necessary or useful to: (A) exercise UCB’s rights under Article
9.1(b)(i) through (iv), and (B) if UCB is a Manufacturer, as necessary to
satisfy UCB’s obligations under this Agreement and any Manufacturing Agreement
to which it is a party; in each case only in accordance with and subject to the
terms of this Agreement.


 


(c)                                  The licences and
sublicences granted by UCB pursuant to Article 9.1(a) shall, to the extent
possible:  (i) be [***] [Confidential
Treatment Required] with respect to:  (A)
Development activities relating to Antibody Products for Agreed Indications in
the Field in the Territory; (B) Post-Approval Studies for Antibody Product in
the Field in the Territory; and (C) Manufacturing activities relating to
Antibody Products in the Field in the Territory; and (ii) be [***]
[Confidential Treatment Required] to ImClone and its Affiliates with respect
to:  (A) Development activities relating
to Antibody Products for Independent Indications for which ImClone is the
Continuing Party in the Field in the Territory and (B) Commercialisation
activities (other than Post-Approval Studies) related to Antibody Products in
the Field in the ImClone Territory.  In
so far as UCB does not[***] [Confidential Treatment Required].


 


(d)                                 The licences and
sublicences granted by ImClone pursuant to Article 9.1(b) shall, to the extent
possible: (i) be [***] [Confidential Treatment Required] with respect to:  (A) Development activities relating to
Antibody Products for Agreed Indications in the Field in the Territory; (B)
Post-Approval Studies for Antibody Product in the Field in the Territory; and
(C) Manufacturing activities relating to Antibody Products in the Field in the
Territory; and (ii) be [***] [Confidential Treatment Required] with respect
to:  (A) Development activities relating
to Antibody Products for Independent Indications for which UCB is the
Continuing Party in the Field in the Territory and (B) Commercialisation
activities (other than Post-Approval Studies) related to Antibody Products in
the Field in the UCB Territory. In so far as ImClone does not [***]
[Confidential Treatment Required]


 


(e)                                  From and after the
Effective Date during the Term neither Party shall, and each Party shall
procure that its Affiliates and sublicensees shall, not use or exercise any
rights granted to it pursuant to this Agreement save for the purposes of
Development, Manufacturing and Commercialising Antibody Products in accordance
with and subject to the terms of this Agreement.


 


(f)                                    For purposes of
this Article 9.1, co-exclusive shall mean that the Party granting the
co-exclusive licence shall not have the right to grant further licences to
Third Parties under its relevant intellectual property rights if and to the
extent such further licences would be inconsistent with an exclusive grant of
such rights to the other Party, except to the extent that it would be permitted
to grant sublicences to such intellectual property rights under Article 9.5
were such intellectual property rights licensed to it by the other Party.


 


(g)                                 Without limiting
any other grant made pursuant to this Agreement, UCB (on behalf of itself and
its Affiliates) grants to ImClone a [***] [Confidential Treatment Required].


 


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9.2                               Third Party Licences


 


Certain licence rights granted to a Party under
this Article 9 may include a sublicence of Patent Rights, Information and/or
Materials of Third Parties under In-Licences. 
Notwithstanding anything to the contrary in this Agreement the
sublicence rights granted pursuant to Article 9.1 shall not be interpreted to
exceed the scope of rights granted under the In-Licences in relation to the
rights covered by such In-Licences, in each case as disclosed to the
sublicensee Party.  Each Party shall
promptly provide to the other Party a copy of any notice of breach received by it
in respect of any In-Licence, and shall use [***] [Confidential Treatment
Required] to promptly cure any such breach.


 


9.3                               Obligation to Maintain In-Licences


 


Neither Party shall terminate or amend an
In-Licence in any manner that affects [***] [Confidential Treatment
Required].  Each Party shall promptly
notify to the other Party any notice of termination received by it in respect
of any In-Licence.


 


9.4                               Trademark Licences/Promotional Materials


 


(a)                                  Each Party hereby
grants to the other Party [***] [Confidential Treatment Required] with the right
to grant sublicences, to use each Product Trademark for each Antibody Product
in respect of which it is the Product Trademark Owner, in each case solely in
furtherance of the other Party’s Development activities for such Antibody
Products in the countries for which such first Party is the Product Trademark
Owner pursuant to this Agreement.


 


(b)                                 Each Party, on
behalf of itself and its Affiliates, hereby grants to the other Party, a [***]
[Confidential Treatment Required] with the right to grant sublicences, to use
such granting Party’s Corporate Mark solely in connection with Promotional
Materials, packaging and Product Labelling for Antibody Products, limited in
scope to the uses specified in Article 6.12.


 


(c)                                  Each Party grants
to the other Party a [***] [Confidential Treatment Required], to reproduce,
distribute copies of, prepare derivative works of, and publicly perform and
display Promotional Materials or additional Antibody Product-specific materials
solely in connection with Antibody Products in the Field in the ImClone
Territory or UCB Territory (as appropriate) and in accordance with and subject
to the terms of this Agreement.


 


9.5                               Sublicences


 


(a)                                  Each Party shall
have the right to grant sublicences to its Affiliates under the licences
granted to it in Articles 9.1(a), 9.1(b), 9.1(g) and 9.4, as the case may be,
[***] [Confidential Treatment Required], but subject to any approvals required
therefor from any applicable Third Party licensor.


 


(b)                                 ImClone and its
Affiliates shall have the right to grant sublicences to Third Parties through
multiple tiers under the licences granted to it in Articles 9.1(a) and 9.4, as
the case may be:


 


72





















 


(i)                                     with the consent of
UCB, if and to the extent that the sublicence permits the sublicensee to use or
exploit the relevant sublicensed rights [***] [Confidential Treatment
Required]; and


 


(ii)                                  with the consent of
UCB [***] [Confidential Treatment Required], if and to the extent that the
sublicence permits the sublicensee to use or exploit the relevant sublicensed
rights [***] [Confidential Treatment Required],


 


but subject, in each case, to any approvals
required therefor from any applicable Third Party licensor.


 


(c)                                  UCB and its
Affiliates shall have the right to grant sublicences to Third Parties through
multiple tiers under the licences granted to it in Articles 9.1(b) and 9.4, as
the case may be:


 


(i)                                     with the consent of
ImClone, if and to the extent that the sublicence permits the sublicensee to
use or exploit the relevant sublicensed rights [***] [Confidential Treatment
Required]


 


(ii)                                  with the consent of
ImClone [***] [Confidential Treatment Required], if and to the extent that the
sublicence permits the sublicensee to use or exploit the relevant sublicensed
rights [***] [Confidential Treatment Required]; and


 


(iii)                               without the consent
of, but following reasonable consultation with, ImClone if and to the extent
that the sublicence permits the sublicensee to use or exploit the relevant
sublicensed rights [***] [Confidential Treatment Required],


 


but subject, in each case, to any approvals
required therefor from any applicable Third Party licensor.


 


(d)                                 Subject to Articles
9.5(a), (b) and (c), neither Party shall have the right to grant sublicences
under the licences granted to it in Articles 9.1(a), 9.1(b) and/or 9.4, as the
case may be, [***] [Confidential Treatment Required].


 


(e)                                  Each Party hereby
guarantees the performance of its Affiliates and permitted sublicensees that
are sublicensed as permitted in this Article 9.5
and the grant of any such sublicence shall not relieve the sublicensing Party
of its obligations under this Agreement, except to the extent they are
satisfactorily performed by such sublicensee. 
Any such permitted sublicences shall be subordinate to, consistent with
and subject to the terms and conditions of this Agreement and any applicable
In-Licences.  A copy of any sublicence
agreement executed by one Party shall be provided to the other Party within
[***] [Confidential Treatment Required] after its execution; provided that the financial terms of any
such sublicence agreement may be redacted to the extent not pertinent to an
understanding of a Party’s obligations or benefits under this Agreement.  Any sublicence agreement with a Third Party
undertaking Commercialisation activity with respect to an Antibody Product


 


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for an Agreed Indication shall be in writing
and shall contain the following provisions:


 


(i)                                     [***] [Confidential
Treatment Required]


 


(ii)                                  [***] [Confidential
Treatment Required]


 


(iii)                               [***] [Confidential
Treatment Required]


 


(f)                                    Each Party shall
use [***] [Confidential Treatment Required] to ensure that any sublicence
agreement it enters into with a Third Party provides that on termination of the
licences granted to the relevant Party pursuant to this Agreement (or those
which are subject to the sublicence), the Remaining Party may elect to replace
the Non-Remaining Party as licensor under such sublicence agreement.


 


(g)                                 ImClone and its
Affiliates shall have the right to grant sublicences to Third Parties through
multiple tiers under the licences granted to it in Article 9.1(g) without the
consent of UCB.


 


10.                               RIGHTS IN INTELLECTUAL PROPERTY


 


10.1                        Ownership


 


(a)                                  Independent
Ownership


 


Subject to the licence grants under Article 9
and except as otherwise provided in Article 4.10 and Article 9.1(c), as between
the Parties, each Party shall own and retain all right, title and interest in
and to any and all: (a) Information, Materials and inventions that are
characterised, conceived, developed, derived, discovered, generated, identified
or otherwise made, by or on behalf of such Party (or its Affiliates or its
licensees or sublicensees (other than the other Party and its Affiliates)) as
determined in accordance with Article 10.1(e) under or in connection with this
Agreement, whether or not patented or patentable, and any and all Patent
Rights, copyrights, trademark rights, trade secret rights and other
intellectual property or other proprietary rights with respect thereto, except
to the extent that any such Information, Materials or inventions, or any Patent
Rights or such other intellectual property or other proprietary rights with
respect thereto, are Joint Know-How or Joint Patents, and (b) other
Information, Materials or inventions, and Patent Rights and such other
intellectual property rights (including the Corporate Marks but excluding Joint
Patent Rights and Joint Know-How) that are owned or otherwise Controlled by
such Party, its Affiliates or its licensees or sublicensees (other than the
other Party and its Affiliates).


 


(b)                                 Product
Trademark


 


As between the Parties, each Party shall own
all right, title and interest in and to the Product Trademark [***]
[Confidential Treatment Required] (each Party being the Product Trademark Owner [***] [Confidential
Treatment Required]).


 


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(c)                                  Manufacturing
Patents and Know How


 


As between the Parties, ownership of
Manufacturing Know-How and Manufacturing Patents generated by or on behalf of a
Party as a result of its activities as a Manufacturer shall be governed by the
terms of the applicable Manufacturing Agreement or existing supply agreement
listed in Schedule 4.


 


(d)                                 Joint
Ownership


 


Each Party shall own an undivided one-half
interest in and to the Joint Patent Rights and the Joint Know-How with full
ownership rights in and to any field and each Party shall have the right, subject
to the rights and licences granted under, and the other provisions of, this
Agreement, to freely exploit, transfer, license or encumber its rights in any
such jointly owned subject matter (together with all Patent Rights and other
intellectual property and proprietary rights in that subject matter) without
the consent of, or payment or accounting to, the other Party, and each Party
waives any right it may have under any Applicable Law to require such payment,
accounting or consent.  This Article
shall survive termination of this Agreement howsoever caused.  During the Term, each Party shall promptly
disclose to the other Party in writing, and shall cause its Affiliates and
sublicensees to so disclose, the characterisation, conception, development,
derivation, discovery, generation, identification or making of any Information,
Materials or inventions (but, for clarification, excluding any Manufacturing
Know-How) in the course of work conducted under or in connection with this
Agreement.  Each Party shall, and does
hereby, assign, and shall cause its Affiliates and sublicensees to so assign,
to the other Party, without additional compensation, such right, title and
interest in and to any Joint Patent Rights or Joint Know-How as well as any
intellectual property or other proprietary rights with respect thereto, as is
necessary to fully effect the joint ownership provided for in this Article
10.1(d).


 


(e)                                  Inventorship
Determination; Identification of Collaboration Inventions


 


The JPC shall, within a reasonable time after
the Effective Date, establish and oversee a mutually agreeable procedure for
identifying and determining inventorship of inventions made pursuant to the
Development, Commercialisation and Manufacturing (but excluding Manufacturing
Know-How) or other activities conducted under or in connection with this
Agreement.  All such determinations and
designations shall be documented to ensure that any applications for Patent
Rights reflect appropriate inventorship and that inventions and Patent Rights
are assigned to or held by the appropriate Party.  The determination of whether any Information,
Material or invention is characterized, conceived, developed, derived,
discovered, generated, identified or otherwise made by a Party or any of its
Affiliates, sublicensees or Distributors shall be made in accordance with
Applicable Law in the United States.


 


(f)                                    No
Obligation to Licence


 


Other than as expressly set out in this
Agreement, neither Party shall have any right in and to intellectual property
owned or Controlled by the other Party and neither Party shall have an
obligation to grant the other Party any rights in or to any such intellectual
property.


 


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(g)                                 Reservation
of Prosecution Right


 


Other than as expressly set out in this Article
10, neither Party shall have the right to prepare, file, apply for, register,
prosecute, maintain, defend, litigate, settle and/or enforce Patent Rights or
Trademarks Controlled by the other Party, such activity being the exclusive
right (but not the obligation) of the Party Controlling the same.


 


10.2                        Covenants Related to Product Trademarks and Corporate Marks


 


(a)                                  During the period
commencing on the Effective Date and ending on the date (if any) on which the
Product Trademark Owner assigns (or is obliged to assign) to the other Party
pursuant to Article 12.8(c), the Product Trademark Owner’s right, title and
interest in and to the Product Trademarks, such other Party acknowledges and
agrees that (i) [***] [Confidential Treatment Required] and (ii) all use of
such Product Trademarks in the countries for which the Product Trademark Owner
is the Territorial Lead whether in combination with or apart from the Product
Trademark Owner’s Corporate Marks, including any goodwill generated in
connection therewith, inures to the benefit of the Product Trademark Owner, and
the Product Trademark Owner may call for a confirmatory assignment
thereof.  Each Party shall use [***]
[Confidential Treatment Required] not to do any act which endangers, destroys
or similarly affects, in any material respect, the value of the goodwill
pertaining to the Product Trademarks.


 


(b)                                 Each Party agrees
that it shall not attack, dispute or contest the validity of or ownership of
the other Party’s Corporate Mark, or any registration issued or issuing with
respect thereto.  Each Party expressly
acknowledges and agrees that no ownership rights are vested or created in the
other Party’s Corporate Marks by the limited rights of use granted pursuant to
Article 9.4(b), and that all use of such Corporate Marks in accordance
therewith, including any goodwill generated in connection therewith, inures to
the benefit of the owner of such Corporate Marks and the owner of such
Corporate Marks may call for a confirmatory assignment thereof.  With respect to any Corporate Marks licensed
to a Party under Article 9.4(b), such Party agrees to conform to the customary
guidelines and quality standards of the granting Party with respect to manner of
use (as provided in writing by the owner of the Corporate Marks).  Each Party shall use [***] [Confidential
Treatment Required] not to do any act which endangers, destroys or otherwise
adversely affects the value of the goodwill pertaining to the other Party’s
Corporate Marks.  Neither Party shall
use, or allow any of their Affiliates, sublicensees or Distributors to use, in
connection with any Antibody Product any other Trademark that is similar to or
substantially similar to or so nearly resembles any of the other Party’s
Corporate Marks as to be likely to cause deception or confusion.


 


10.3                        Disclosure of Patentable Inventions and Patent Due Diligence


 


(a)                                  Each Party shall
promptly notify the other Party of any patentable invention made by it or its
Affiliates or, to the extent it has rights thereto, sublicensees or
Distributors pursuant to the Development, Commercialisation, Manufacturing or
other activities performed by it or them under this Agreement (but excluding
any patentable invention with respect to Manufacturing Know-How Controlled by a
Third Party Manufacturer), and shall provide to the other


 


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Party any invention disclosure submitted in the
normal course of its business which discloses any such invention.


 


(b)                                 Each Party agrees
to use [***] [Confidential Treatment Required] to bring to the attention of the
Joint Patent Committee in a timely manner any Third Party patent or Third Party
patent application it discovers, or has discovered, and which such Party
reasonably believes relates to, the Development, Commercialisation or
Manufacture of any Antibody Product.


 


10.4                        Patent and Trademark Filing, Prosecution and Maintenance


 


(a)                                  ImClone
Patent Rights and ImClone Company Marks


 


(i)                                     ImClone Core Patent
Rights


 


Decisions regarding the preparation, filing,
prosecution and maintenance of ImClone Core Patent Rights shall be made by
ImClone following reasonable consultation with the JPC.  Prior to implementing any decision regarding
the preparation, filing, prosecution and maintenance of such ImClone Core
Patent Rights, ImClone shall give due consideration to any representation made
by the JPC with respect to such preparation, filing, prosecution and
maintenance.  ImClone shall provide the
JPC with an opportunity to review and comment upon the text of the applications
relating to such ImClone Core Patent Rights before filing.  ImClone shall provide the JPC with a copy of
each patent application within such ImClone Core Patent Rights as filed,
together with notice of its filing date and serial number.  ImClone shall keep the JPC advised of the
status of all communications, actual and prospective filings or submissions
regarding such ImClone Core Patent Rights, and shall give the JPC an
opportunity to review and comment on any such communications, filing and
submissions proposed to be sent to any patent office.  Notwithstanding the foregoing, ImClone shall
not cease the prosecution and/or maintenance of, or elect not to file a patent
application in respect of any ImClone Core Patent Rights, unless otherwise
approved by the JPC [***] [Confidential Treatment Required].  All out of pocket costs incurred by the
Parties in connection with the preparation, filing, prosecution and maintenance
of ImClone Core Patent Rights shall be [***] [Confidential Treatment Required]


 


(ii)                                  Other ImClone
Patent Rights and ImClone Company Marks


 


Decisions regarding the preparation, filing,
prosecution and maintenance of ImClone Company Marks and ImClone Patent Rights,
other than ImClone Core Patent Rights, shall be made by ImClone.


 


(b)                                 UCB
Patent Rights and UCB Company Marks


 


(i)                                     UCB Core Patent
Rights


 


Decisions regarding the preparation, filing,
prosecution and maintenance of UCB Core Patent Rights shall be made by UCB
following reasonable consultation with the JPC. 
Prior to implementing any decision regarding the


 


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preparation, filing, prosecution and
maintenance of such UCB Core Patent Rights, UCB shall give due consideration to
any representations made by the JPC with respect to such preparation, filing,
prosecution and maintenance.  UCB shall
provide the JPC with an opportunity to review and comment upon the text of the
applications relating to such UCB Core Patent Rights before filing.  UCB shall provide the JPC with a copy of each
patent application within such UCB Core Patent Rights as filed, together with
notice of its filing date and serial number. 
UCB shall keep the JPC advised of the status of all communications,
actual and prospective filings or submissions regarding such UCB Core Patent
Rights, and shall give the JPC an opportunity to review and comment on any such
communications, filing and submissions proposed to be sent to any patent
office.  Notwithstanding the foregoing,
UCB shall not cease the prosecution and/or maintenance of, or elect not to file
a patent application in respect of any UCB Core Patent Rights, unless otherwise
approved by the JPC [***] [Confidential Treatment Required].  All out of pocket costs incurred by the
Parties in connection with the preparation, filing, prosecution and maintenance
of UCB Core Patent Rights shall be [***] [Confidential Treatment Required].


 


(ii)                                  Other UCB Patent
Rights and UCB Company Marks.


 


Decisions regarding the preparation, filing,
prosecution and maintenance of UCB Company Marks and UCB Patent Rights, other
than UCB Core Patent Rights, shall be made by UCB.


 


(c)                                  Joint
Patent Rights


 


Decisions regarding the preparation, filing,
prosecution and maintenance of the Joint Patent Rights shall be made by the
JPC.  Upon the identification of Joint
Know-How, the JPC shall: (i) promptly discuss such Joint Know-How; (ii)
promptly discuss the desirability of filing patent application(s) covering such
Joint Know-How, and the relevant countries for filing; (iii) make the final
decision with respect to any such filings as soon as practicable; and (iv)
designate the Party (the Controlling Party)
to be responsible for the preparation, filing, prosecution and maintenance of
such Joint Patent Rights, with the expectation being that each Party shall be
the Controlling Party with respect to Joint Patent Rights in countries for
which it is the Territorial Lead, provided
that no Party shall be designated as a Controlling Party without its written
consent.  All out of pocket costs incurred
by the Parties in connection with the preparation, filing, prosecution and
maintenance of Joint Patent Rights [***] [Confidential Treatment
Required].  The Controlling Party shall
be responsible, using in-house counsel or outside counsel reasonably acceptable
to both Parties, to implement the decisions of the JPC regarding the
preparation, filing, prosecution and maintenance of such Joint Patent
Rights.  The Controlling Party shall (A)
provide the JPC an opportunity to review and comment upon the text of the
applications relating to; (B)  provide
the JPC with a copy of each patent application filed, together with notice of
the filing date and serial number of; (C) keep the JPC advised of the status of
all communications, actual and prospective filings or submissions regarding;
(D) provide the JPC an opportunity to review and comment on any communications,
filings and submissions proposed to be sent to any patent office relating to;
(E) notify the JPC of the grant of; (F) not, unless otherwise approved by the
JPC [***] [Confidential Treatment Required], cease the prosecution or
maintenance of, or


 


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modify the claims of, or elect not to file a
patent application in respect of; any Joint Patent Rights.  If one Party [***] [Confidential Treatment
Required].  If the other Party fails to
notify the first Party within [***] [Confidential Treatment Required], and the
first Party is the Controlling Party, the Controlling Party [***] [Confidential
Treatment Required] such Joint Patent Rights during that [***] [Confidential
Treatment Required]).


 


(d)                                 Product
Trademarks


 


Decisions regarding the preparation, filing,
prosecution and maintenance of registrations for the Product Trademarks in a
country shall be made by, and registrations for the Product Trademarks in a
country shall be filed and prosecuted by, the Product Trademark Owner in such
country, and any expenses related to such preparation (including clearance of
marks), filing, prosecution or maintenance [***] [Confidential Treatment
Required], provided the other
Party shall have a reasonable opportunity to review and comment upon drafts of
any new application to register a Product Trademark and all correspondence,
amendments and submissions of any kind to any and all trademark offices
concerning the Product Trademark registrations, prior to filing that
application, correspondence, amendment or submission.  Notwithstanding the foregoing, if a Product
Trademark Owner declines to prepare, file or prosecute any Trademark registration,
or maintain any such Trademark, comprising Product Trademarks for which it is
the Product Trademark Owner as required by this Article 10.4(d), it shall give
the other Party reasonable notice to this effect and, the other Party may, upon
written notice to the Product Trademark Owner, prepare, file, prosecute and
maintain such Product Trademarks in the name of the Product Trademark Owner and
any expenses related to such filing, prosecution or maintenance shall be [***]
[Confidential Treatment Required].


 


(e)                                  Patent
Term Extensions


 


The JPC shall make determinations as to whether
to seek patent term extensions, including supplementary protection certificates
and any other extensions that are now or become available in the future
regarding the ImClone Core Patent Rights, UCB Core Patent Rights or Joint
Patent Rights with respect to the Antibody Products in each country in the
Territory so as to secure optimal protection for each such Antibody Product
under Applicable Law, provided
that no such extensions shall be sought with respect to the UCB Core Patent
Rights without UCB’s prior consent or the ImClone Core Patent Rights without
ImClone’s prior consent.  ImClone shall
be responsible for implementing any patent term extensions, including
supplementary protection certificates and any other extensions that are now or
become available in the future, for the ImClone Core Patents and UCB shall be
responsible for implementing patent term extensions, including supplementary
protection certificates and any other extensions that are now or become
available in the future, for the UCB Core Patents.  The Controlling Party shall be responsible
wherever applicable, for implementing any patent term extensions, including
supplementary protection certificates and any other extensions that are now or
become available in the future, for Joint Patent Rights.  Each Party shall [***] [Confidential
Treatment Required] cooperate, as requested by the other Party, to implement
such decisions of the Joint Patent Committee. 
Any costs incurred in connection with seeking patent term extensions
shall be [***] [Confidential Treatment Required].


 


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10.5                        Interferences, Reexaminations, Reissues, Revocations and
Oppositions With Third Parties


 


(a)                                  ImClone
Core Patent Rights and Product Trademarks for which ImClone is the Product
Trademark Owner


 


All decisions relating to Adversarial
Prosecution Actions with respect to ImClone Core Patent Rights or Product
Trademarks for which ImClone is the Product Trademark Owner, including whether
to initiate or settle such Adversarial Prosecution Actions, shall be made by
ImClone having consulted with, and with the advice of, the JPC.  ImClone shall be responsible for the conduct
of any such Adversarial Prosecution Action. 
UCB shall [***] [Confidential Treatment Required] cooperate, as
requested by ImClone, with respect to such Adversarial Prosecution Action.  ImClone shall keep the JPC informed of the
progress of any such Adversarial Prosecution Action.  ImClone shall keep the JPC advised of all
communications, actual and prospective filings or submissions regarding such
Adversarial Prosecution Action, and shall provide the JPC with an opportunity
to review and comment on any such communications, filings and submissions, provided that ImClone shall have the first
right to conduct (including to initiate, defend and control, including the
right to settle or compromise and to grant licences under the ImClone Core
Patent Rights or Product Trademarks for which ImClone is the Product Trademark
owner in connection therewith) any such Adversarial Prosecution Action.   If ImClone fails to institute an Adversarial
Prosecution Action with respect to ImClone Core Patent Rights or a Product
Trademark in a country where ImClone is the Product Trademark Owner within
[***] [Confidential Treatment Required] after a written request by UCB to do
so, or otherwise conduct or defend any such Adversarial Prosecution Action,
within [***] [Confidential Treatment Required] after a written request by UCB
to do so, then UCB, on written notice to ImClone, shall have the right, during
or after the Term, [***] [Confidential Treatment Required] to initiate, conduct
or defend, as applicable, and control, such Adversarial Prosecution Action provided that UCB shall not settle or
consent to a judgment in any such Adversarial Prosecution Action if such
settlement or judgment would have a material adverse effect on ImClone unless
approved by ImClone [***] [Confidential Treatment Required].  All out-of-pocket expenses incurred in
relation to any Adversarial Prosecution Action under this Article 10.5(a) shall
be [***] [Confidential Treatment Required].


 


(b)                                 Other
ImClone Patent Rights and ImClone Company Marks


 


All decisions relating to Adversarial Prosecution
Actions with respect to ImClone Company Marks and ImClone Patent Rights, other
than ImClone Core Patent Rights, including whether to initiate or settle such
Adversarial Prosecution Actions, shall be made by ImClone.  All expenses incurred and recoveries obtained
in relation to any such Adversarial Prosecution Action shall be [***]
[Confidential Treatment Required].


 


(c)                                  UCB
Core Patent Rights and Product Trademarks for which UCB is the Product
Trademark Owner


 


All decisions relating to Adversarial
Prosecution Actions with respect to UCB Core Patent Rights or Product
Trademarks for which UCB is the Product Trademark Owner, including whether to
initiate or settle such Adversarial Prosecution Actions,


 


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shall be made by UCB having consulted with, and
with the advice of, the JPC.  UCB shall
be responsible for the conduct of any such Adversarial Prosecution Action.  ImClone shall [***] [Confidential Treatment
Required] cooperate, as requested by UCB, with respect to such Adversarial
Prosecution Action.  UCB shall keep the
JPC informed of the progress of any such Adversarial Prosecution Action.  UCB shall keep the JPC advised of all
communications, actual and prospective filings or submissions regarding such
Adversarial Prosecution Action, and shall provide the JPC with an opportunity
to review and comment on any such communications, filings and submissions, provided that UCB shall have the first
right to conduct (including to initiate, defend and control, including the
right to settle or compromise and to grant licences under the UCB Core Patent
Rights or Product Trademarks for which UCB is the Product Trademark Owner in
connection therewith) any such Adversarial Prosecution Action.  If UCB fails to institute an Adversarial
Prosecution Action with respect to UCB Core Patent Rights or a Product
Trademark in a country where UCB is the Product Trademark Owner within [***]
[Confidential Treatment Required] after a written request by ImClone to do so,
or otherwise conduct or defend any such Adversarial Prosecution Action, within
[***] [Confidential Treatment Required] after a written request by ImClone to
do so, then ImClone, on written notice to UCB, shall have the right, during or
after the Term, at its sole discretion to initiate, conduct or defend, as
applicable, and control, such Adversarial Prosecution Action provided that ImClone shall not settle or
consent to a judgment in any such Adversarial Prosecution Action if such
settlement or judgment would have a material adverse effect on UCB unless
approved by UCB [***] [Confidential Treatment Required].  All out-of-pocket expenses incurred in
relation to any Adversarial Prosecution Action under this Article 10.5(c) shall
be [***] [Confidential Treatment Required].


 


(d)                                 Other
UCB Patent Rights and UCB Company Marks


 


All decisions relating to Adversarial
Prosecution Actions with respect to UCB Company Marks and UCB Patent Rights,
other than UCB Core Patent Rights, including whether to initiate or settle such
Adversarial Prosecution Actions, shall be made by UCB.  All expenses incurred and recoveries obtained
in relation to any such Adversarial Prosecution Action shall be borne or
retained, as applicable, by UCB.


 


(e)                                  Joint
Patent Rights, Third Party Patent Rights and Third Party Trademarks


 


Decisions relating to Adversarial Prosecution
Actions with respect to Joint Patent Rights and decisions relating to
Adversarial Prosecution Actions against Third Party Patent Rights or Third
Party Trademarks relevant to an Antibody Product, including in each case
decisions whether to initiate or settle such Adversarial Prosecution Actions,
shall be made by the JPC.  Upon the
identification of any such potential Adversarial Prosecution Action, the JPC
shall: (i) promptly discuss such Adversarial Prosecution Action, including the
strategy for conducting such Adversarial Prosecution Action; and
(ii) designate a Party (the Managing
Party) to be responsible for controlling such Adversarial
Prosecution Action, provided that
no Party shall be designated as a Managing Party [***] [Confidential Treatment
Required].  The Managing Party shall be
responsible, using outside counsel reasonably acceptable to both Parties, to
implement the decisions of the Joint Patent Committee regarding such Adversarial
Prosecution Action.  Save as provided in
this Article 10.5(e), all expenses incurred in relation to any such Adversarial
Prosecution Action shall be [***]


 


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[Confidential Treatment Required].  The non-Managing Party shall [***]
[Confidential Treatment Required]cooperate, as requested by the JPC or the
Managing Party, in such Adversarial Prosecution Action.  The Managing Party shall keep the JPC
informed of the progress of any such Adversarial Prosecution Action.  The Managing Party shall keep the JPC advised
of all communications, actual and prospective filings or submissions regarding
such Adversarial Prosecution Action, and shall provide the JPC an opportunity
to review and comment on any such communications, filings and submissions.  The Managing Party shall not settle or
consent to a judgment in any such Adversarial Prosecution Action with respect
to the Joint Patent Rights, Third Party Patent Rights or Third Party
Trademarks, unless approved by the JPC [***] [Confidential Treatment
Required].  If a Party does not wish to
share the costs of prosecuting any such Adversarial Prosecution Actions against
Third Party Patent Rights or Third Party Trademarks relevant to an Antibody
Product, the other Party shall have the right to prosecute such action, at its
sole expense, through counsel of its choosing, without the consent of such
first Party or the JPC, provided
that that such other Party shall be [***] [Confidential Treatment
Required].  If a Party elects to initiate
or continue prosecuting an Adversarial Prosecution Actions against Third Party
Patent Rights or Third Party Trademarks relevant to an Antibody Product at its
own expense as provided in the preceding sentence, the other Party shall, and
shall cause its Affiliates to, [***] [Confidential Treatment Required]cooperate
with such first Party in this regard. 
For clarity, neither Party shall have the right not to fund, or to cease
defending, an Adversarial Prosecution Action brought by a Third Party with
respect to Joint Patent Rights, except with respect to a counterclaim brought
by a Third Party in connection with an Adversarial Prosecution Action against a
Third Party Patent as to which such Party previously exercised its right not to
fund.


 


10.6                        Initial Filings


 


The Parties agree to use [***] [Confidential
Treatment Required] to ensure that any Patent Rights within the ImClone Core
Patent Rights, UCB Core Patent Rights and Joint Patent Rights will be in a form
sufficient to establish the date of original filing as a priority date for the
purposes of filing throughout the Territory.


 


10.7                        Enforcement and Defence of Patent Rights and Trademarks


 


(a)                                  Notification
of Infringement


 


If either Party learns of any Third Party
making, using, offering for sale, selling or importing an Antibody Product or a
Competing Product, in each case in or outside of the Field, or using a
Trademark that could reasonably be deemed to infringe a Product Trademark, the
Joint Patent Rights or one of the other Party’s Patent Rights or Trademarks,
such Party shall promptly notify the other Party and shall provide such other
Party with available evidence of such activity.


 


(b)                                 Enforcement


 


(i)                                     ImClone Core Patent
Rights and Product Trademarks for which ImClone is the Product Trademark Owner


 


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As between the Parties, ImClone shall with
respect to ImClone Core Patent Rights and Product Trademarks for which ImClone
is the Product Trademark Owner during the Term have the first right and
thereafter with respect to ImClone Core Patent Rights, the sole right, using
outside counsel selected by ImClone, to initiate or defend (as appropriate) and
control Enforcement Actions with respect to ImClone Core Patent Rights and
Product Trademarks for which ImClone is the Product Trademark Owner.  UCB shall [***] [Confidential Treatment
Required] cooperate, as requested by ImClone, with respect to such Enforcement
Actions.  ImClone shall keep the JPC
informed of the progress of any such Enforcement Action.  ImClone shall keep the JPC advised of all
communications, actual and prospective filings and submissions regarding any
such Enforcement Action and shall provide the JPC with an opportunity to review
and comment on any such communications, filings and submissions.  If ImClone fails during the Term to institute
or defend any such Enforcement Action with respect to ImClone Core Patent
Rights or a Product Trademark for which ImClone is the Product Trademark Owner,
within [***] [Confidential Treatment Required] after a written request by UCB
to do so, then UCB, on written notice to ImClone, shall have the right at its
sole discretion to initiate or defend (as appropriate) and control such
Enforcement Action in the name of either or both Parties provided that UCB shall not settle or
consent to a judgment in any such Enforcement Action if such settlement or
judgment would have a material adverse effect on ImClone unless approved by
ImClone [***] [Confidential Treatment Required].  If, after the Term, ImClone fails to initiate
or defend any such Enforcement Action with respect to ImClone Core Patent
Rights, UCB shall have no right to initiate or defend and control such
Enforcement Action but any [***] [Confidential Treatment Required]  All out of pocket expenses incurred in
relation to any Enforcement Action under this Article 10.7(b)(i) shall be [***]
[Confidential Treatment Required].


 


(ii)                                  Other ImClone
Patent Rights and ImClone Company Marks


 


All decisions relating to Enforcement Actions
with respect to ImClone Company Marks and ImClone Patent Rights, other than
ImClone Core Patent Rights, including whether to initiate, defend or settle
such Enforcement Actions, shall be made by ImClone.  ImClone shall have the exclusive right, using
counsel selected by ImClone, to initiate or defend (as appropriate) and control
such Enforcement Actions.  UCB shall
[***] [Confidential Treatment Required] cooperate, as requested by ImClone and
at ImClone’s expense, with respect to such Enforcement Actions that relate to
Antibody Products.  ImClone shall keep
the JPC informed of the progress of any such Enforcement Actions that relate to
Antibody Products.  All expenses incurred
and recoveries obtained in relation to any such Enforcement Action shall be
[***] [Confidential Treatment Required].


 


(iii)                               UCB Core Patent
Rights and Product Trademarks for which UCB is the Product Trademark Owner


 


As between the Parties, UCB shall with respect
to UCB Core Patent Rights and Product Trademarks for which UCB is the Product
Trademark Owner during the Term have the first right and thereafter with
respect to UCB Core


 


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Patent Rights, the sole right, using outside
counsel selected by UCB, to initiate or defend (as appropriate) and control
Enforcement Actions with respect to UCB Core Patent Rights and Product
Trademarks for which UCB is the Product Trademark Owner.  ImClone shall [***] [Confidential Treatment
Required] cooperate, as requested by UCB, with respect to such Enforcement
Actions.  UCB shall keep the JPC informed
of the progress of any such Enforcement Action. 
UCB shall keep the JPC advised of all communications, actual and
prospective filings and submissions regarding any such Enforcement Action and
shall provide the JPC with an opportunity to review and comment on any such
communications, filings and submissions. 
If UCB fails, during the Term, to institute or defend any such
Enforcement Action with respect to UCB Core Patent Rights or a Product
Trademark for which UCB is the Product Trademark Owner within [***]
[Confidential Treatment Required] after a written request by ImClone to do so,
then ImClone, on written notice to UCB, shall have the right at its sole
discretion to initiate or defend (as appropriate) and control such Enforcement
Action in the name of either or both Parties provided
that ImClone shall not settle or consent to a judgment in any such Enforcement
Action if such settlement or judgment would have a material adverse effect on
UCB unless approved by UCB [***] [Confidential Treatment Required].  If, after the Term, UCB fails to initiate or
defend any such Enforcement Action with respect to UCB Core Patent Rights, UCB
shall have no right to initiate or defend and control such Enforcement Action
but any [***] [Confidential Treatment Required].  All out of pocket expenses incurred in
relation to any Enforcement Action under this Article 10.7(b)(iii) shall be
[***] [Confidential Treatment Required].


 


(iv)                              Other UCB Patent
Rights and UCB Company Marks


 


All decisions relating to Enforcement Actions
with respect to UCB Company Marks and UCB Patent Rights, other than UCB Core
Patent Rights, including whether to initiate, defend or settle such Enforcement
Actions, shall be made by UCB.  UCB shall
have the exclusive right, using counsel selected by UCB, to initiate or defend
(as appropriate) and control such Enforcement Actions.  ImClone shall [***] [Confidential Treatment
Required] cooperate, as requested by UCB and at UCB’s expense, with respect to
such Enforcement Actions that relate to Antibody Products.  UCB shall keep the JPC informed of the
progress of any such Enforcement Actions that relate to Antibody Products.  All expenses incurred and recoveries obtained
in relation to any such Enforcement Action shall be [***] [Confidential
Treatment Required].


 


(v)                                 Joint Patent Rights


 


All decisions relating to Enforcement Actions
with respect to Joint Patent Rights shall be made by the JPC.  Upon the identification by a Party of an
actual, alleged or threatened infringement or attack on the validity or
enforceability of a Joint Patent Right, or upon a Party’s request to the JPC to
consider prosecuting or defending an Enforcement Action with respect to Joint
Patent Rights, the JPC shall: (i) promptly discuss such infringement, attack
or Enforcement Action; (ii) promptly discuss the strategy for enforcing or
defending such Joint Patent Rights; and (iii) designate a Party (the Responsible Party) to be responsible for implementing
the decisions of the


 


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JPC with respect to such infringement, attack
or Enforcement Action.  The Responsible
Party shall, using outside counsel reasonably acceptable to both Parties,
implement the decisions of the JPC regarding such Enforcement Action.  Save as provided in this Article 10.7(b)(v),
all expenses incurred in relation to any such Enforcement Action shall be [***]
[Confidential Treatment Required].  The
non-Responsible Party shall [***] [Confidential Treatment Required] cooperate,
as requested by the JPC or the Responsible Party, in such Enforcement Action,
including joining any such Enforcement Action. 
The Responsible Party shall keep the JPC informed of the progress of any
such Enforcement Action.  The Responsible
Party shall keep the JPC advised of all communications, actual and prospective
filings or submissions regarding any such Enforcement Action, and provide the
JPC with an opportunity to review and comment on any such communications,
filing and submissions proposed to be made by the Responsible Party.  The Responsible Party shall not settle or
consent to a judgment in any such Enforcement Action with respect to Joint
Patent Rights, unless approved by the JPC [***] [Confidential Treatment
Required].  Notwithstanding the
foregoing, if a Party does not wish to [***] [Confidential Treatment Required]
of prosecuting any such Enforcement Action, the other Party shall have the
right to prosecute such Enforcement Action, through counsel of its choosing,
without the consent of such first Party or the JPC, provided that the other Party shall [***] [Confidential
Treatment Required].  If a Party elects
to initiate or continue prosecuting an Enforcement Action as provided in the
preceding sentence, the other Party shall, and shall cause its Affiliates to,
(x) [***] [Confidential Treatment Required] cooperate with such first Party in
this regard, and (y) promptly release or assign to the other Party, without
consideration, all right, title and interest in and to such Joint Patent
Rights.  For clarity, neither Party shall
have the right to not fund, or to cease defending, an Enforcement Action
brought by a Third Party, except with respect to a counterclaim brought by a
Third Party in connection with an Enforcement Action as to which such Party
previously exercised its right not to fund.


 


10.8                        Third Party Intellectual Property


 


(a)                                  Jointly
Identified Third Party Intellectual Property


 


If either Party believes that there exist Third
Party intellectual property rights that are [***] [Confidential Treatment
Required] to Develop, Commercialise or Manufacture an Antibody Product in the
Field then it shall notify the JPC, indicating in such notice whether or not a
Party or any of its Affiliates have Control or have a right to acquire Control
of such Third Party intellectual property rights.  Each Party shall provide the JPC with such
details as it has and which it (without breaching any obligation it may have to
a Third Party) is able to provide with respect to such Third Party intellectual
property rights and of any right it or any of its Affiliates may have in or to
the same.  If the JPC determines that
such Third Party intellectual property rights are necessary or desirable to
Develop or Commercialise an Antibody Product in the Field, then the JPC shall
inform the Collaboration Committee.  If
the Collaboration Committee approves the seeking of a licence, the Parties
shall use[***] [Confidential Treatment Required] to obtain such a licence under
such Third Party intellectual property rights on such terms (economic or
otherwise) as the Collaboration Committee determines,


 


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provided that the
Parties agree that they shall use [***] [Confidential Treatment Required] in
the first instance to obtain such a licence to be held by both Parties in the
Territory and if such licence is not obtainable on [***] [Confidential
Treatment Required] terms, the Collaboration Committee shall designate one
Party to use [***] [Confidential Treatment Required] to obtain such a licence
throughout the Territory with the express right to grant a sublicence to the
other Party as such sublicensing Party has with respect to its own intellectual
property under Article 9.1.  No member of
the Collaboration Committee shall [***] [Confidential Treatment Required] withhold
its approval of a licence under Third Party intellectual property rights that
are [***] [Confidential Treatment Required] to Develop, Commercialise or
Manufacture an Antibody Product for an Agreed Indication in the Field.  If a Party (the first Party) (through the
Collaboration Committee) does not agree that it is [***] [Confidential
Treatment Required] to obtain such a licence to avoid infringing a Third
Party’s Patent Rights, then the other Party shall be free to seek such licence
with respect to its own activities, with any costs with respect to such licence
(to the extent disclosed to the JPC prior to obtaining the licence) to be [***]
[Confidential Treatment Required].  If
the first Party is subsequently sued by such Third Party for infringement of
such Third Party Patent; (i) any costs incurred in the defence or settlement of
such action, including any ongoing royalties, damages or other payment
obligations up to and including the amount that would have been payable to the
Third Party had the first Party obtained the relevant licence shall be [***]
[Confidential Treatment Required], and (ii) any costs incurred in the defence
or settlement of such action, including any ongoing royalties, damages or other
payment obligations in excess of that amount shall [***] [Confidential
Treatment Required]. Notwithstanding the foregoing, the Continuing Party shall
have the right, [***] [Confidential Treatment Required] to obtain a licence to
any Third Party intellectual property that relates solely to an Independent
Indication for which it is the Continuing Party without the consent of the
other Party, the JPC or the Collaboration Committee and without securing any
express rights to sublicence to the other Party, unless and until such
Independent Indication is Converted into a Converted Agreed Indication, provided that at the time the Continuing
Party identifies such Third Party intellectual property it shall notify the
Non-Continuing Party in order to enable the Non-Continuing Party, at the
Non-Continuing Party’s option, to negotiate a licence or option with respect to
such Third Party intellectual property that would enable the Non-Continuing
Party to use such Third Party intellectual property in the event that such
Independent Indication is subsequently Converted into a Converted Agreed
Indication.  Each Party shall [***]
[Confidential Treatment Required] in relation to its own licence or option to
such Third Party intellectual property, provided
that, if the Continuing Party at the request of the Non-Continuing Party
secures an express right to sublicense to the Non-Continuing Party in its
licence to such Third Party intellectual property, the Non-Continuing Party
shall [***] [Confidential Treatment Required] by the Continuing Party in
connection with obtaining such right to sublicense provided that such [***] [Confidential Treatment Required]
have been approved in advance by the Non-Continuing Party.  For clarity, the Continuing Party shall not
be obliged to enter into any such licence or option or obtain any such right to
sublicense.


 


In addition, if a Party or any of its
Affiliates has the right to Control any such Third Party intellectual property
rights specifically directed in substantial part to an Antibody Product that
are [***] [Confidential Treatment Required] to Develop an Antibody Product for
an Agreed Indication in the Field, at the written request of the other Party,
such Party shall exercise such right, with any costs with respect to such


 


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exercise (to the extent disclosed to the other
Party in writing prior to such request or otherwise agreed by the Parties) to
be [***] [Confidential Treatment Required] and such Third Party intellectual
property right shall be included in the rights licensed pursuant to this
Agreement and the licence agreement pursuant to which such Control was acquired
shall be deemed to be an In-Licence and Part 1 or Part 2 of Schedule 1 shall be
deemed amended accordingly.


 


(b)                                 Other
Third Party Technology


 


In the event that UCB or ImClone (the Acquiring Party) proposes to apply to an
Antibody Product technology that the Acquiring Party obtains from a Third
Party, whether before or after the Effective Date, other than pursuant to
Article 10.8(a), the Acquiring Party shall disclose the same to the
Collaboration Committee, including any royalty or other payment obligations to
a Third Party determined in accordance with GAAP that would apply as a result
of the Development, Commercialisation or Manufacture of such Antibody Products
for an Agreed Indication under this Agreement. 
The Collaboration Committee shall determine, within [***] [Confidential
Treatment Required], whether or not the Collaboration Committee agrees that
such technology should be applied to such Antibody Product, and if the
Collaboration Committee so determines that it should be, the agreement under
which the Acquiring Party acquires such technology shall be deemed to be an
In-Licence and Part 1 or Part 2 of Schedule 1 shall be deemed amended
accordingly, and any applicable corresponding royalty payments or obligations
shall be treated as [***] [Confidential Treatment Required].  If the Collaboration Committee fails to agree
that such technology should be applied to such Antibody Product, (i) the
subject matter of such agreement shall not be within the definition of UCB
Know-How, ImClone Know-How, UCB Patent Rights or ImClone Patent Rights under
this Agreement, (ii) the other Party shall have no licence or other rights with
respect to such technology, and (iii) to the extent a Party still wishes to
apply such technology to an Antibody Product, it may do so [***] [Confidential
Treatment Required].


 


(c)                                  Third
Party Licences


 


Notwithstanding the provisions of this Article
10, the rights and obligations of the Parties under this Article 10 shall be
subject to the rights and obligations of the licensors under any In-Licences.


 


(d)                                 Third
Party Patents


 


If a Third Party sues a Party alleging that
such Party’s or such Party’s Affiliates’, Distributors’ or sublicensees’
Development, Commercialisation or Manufacturing activities (other than as a
Manufacturer, which shall be governed by the applicable Manufacturing
Agreement) under this Agreement infringe or will infringe said Third Party’s
Patent Rights or misappropriate said Third Party’s trade secret or said Third
Party’s Trademark or other intellectual property, then the sued Party shall
give the other Party and the JPC prompt written notice thereof, and upon the
sued Party’s request and in connection with such Party’s defence of any such
Third Party suit, the other Party shall provide [***] [Confidential Treatment
Required] assistance to the sued Party for such defence and shall join such
suit where required to do so under the Applicable Law.  The sued Party shall keep the JPC and the
other Party, if such other Party has not joined in such suit, reasonably
informed, in person or by telephone,


 


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prior to (if possible) and during the pendency
of any such suit.  The sued Party shall not
admit the invalidity, unenforceability or non-infringement of any Patent Rights
licensed under this Agreement or any infringement of a Third Party Patent in
connection with activities conducted under this Agreement nor settle any such
suit, [***] [Confidential Treatment Required]. 
The [***] [Confidential Treatment Required] out of pocket litigation
costs and expenses incurred by each Party, including settlement costs,
royalties paid in settlement of any such suit, and the payment of any damages
to the Third Party shall be [***] [Confidential Treatment Required].  Any amounts recovered from the Third Party by
way of costs shall be [***] [Confidential Treatment Required].


 


10.9                        Patent and Trademark Marking


 


To the extent practical and permitted by
Applicable Law, each Territorial Lead shall mark Antibody Products sold in its
Territory with all applicable patent numbers of Patent Rights of the Parties
and with notice of Trademark registrations in those countries in which such
markings have notice value as against infringers of Patent Rights or
Trademarks.


 


10.10                 Allocation of Costs


 


(a)                                  [***] [Confidential
Treatment Required] relating to Joint Patent
Rights


 


(i)                                     Subject to Article
10.4(c), Article 10.5(e) and Article 10.7(b)(v), all [***] [Confidential Treatment
Required] relating to Joint Patent Rights shall during the Term be [***]
[Confidential Treatment Required].


 


(ii)                                  Following
termination of this Agreement for any reason, each Party shall provide to the
other within [***] [Confidential Treatment Required] of the end of each
Calendar Quarter a statement setting out the [***] [Confidential Treatment
Required] in that Calendar Quarter in connection with Joint Patent Rights
together with such evidence of such costs as the other Party may reasonably
require.  If and to the extent that one
Party has incurred more costs than the other Party, the other Party shall
within [***] [Confidential Treatment Required].


 


(b)                                 [***] [Confidential
Treatment Required] relating to ImClone Core
Patent Rights


 


All [***] [Confidential Treatment Required]
relating to ImClone Core Patent Rights shall be included in the [***]
[Confidential Treatment Required].


 


(c)                                  [***] [Confidential
Treatment Required] relating to UCB Core
Patent Rights


 


All [***] [Confidential Treatment Required] relating
to UCB Core Patent Rights shall be included [***] [Confidential Treatment
Required].


 


(d)                                 [***] [Confidential
Treatment Required] relating to Product
Trademarks


 


All [***] [Confidential Treatment Required]
relating to Product Trademarks shall be [***] [Confidential Treatment
Required].


 


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(e)                                  [***] [Confidential
Treatment Required] relating to other ImClone
Patent Rights and ImClone Company Marks


 


[***] [Confidential Treatment Required]
relating to ImClone Patent Rights (other than ImClone Core Patent Rights) and
ImClone Company Marks shall [***] [Confidential Treatment Required].


 


(f)                                    [***] [Confidential
Treatment Required] relating to other UCB
Patent Rights and UCB Company Marks


 


[***] [Confidential Treatment Required]
relating to UCB Patent Rights (other than UCB Core Patent Rights) and UCB
Company Marks shall [***] [Confidential Treatment Required].


 


(g)                                 Recoveries


 


If and to the extent that either Party recovers
any amount from a Third Party and the costs incurred in connection with such
recovery constitute [***] [Confidential Treatment Required].  After termination of this Agreement any
recoveries relating to actions relating to Joint Patent Rights that have been
jointly funded by the Parties shall be [***] [Confidential Treatment Required].


 


11.                               CONFIDENTIALITY AND NON-USE


 


11.1                        Confidentiality


 


Except as expressly set out in this Agreement,
the Parties agree that, during the Term and for [***] [Confidential Treatment
Required] following the date of expiration or termination of this Agreement,
the receiving Party shall keep confidential and shall not publish or otherwise
disclose or use for any purpose other than as permitted under the terms of this
Agreement any Confidential Information of the other Party except to the extent
that it can be established by the receiving Party that such Confidential
Information:


 


(a)                                  was already known
to the receiving Party, other than under an obligation of confidentiality, at
the time of disclosure by the other Party;


 


(b)                                 was generally
available to the public or otherwise part of the public domain at the time of
its disclosure to the receiving Party;


 


(c)                                  became generally
available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in
breach of this Agreement;


 


(d)                                 was disclosed to
the receiving Party, other than under an obligation of confidentiality, by a
Third Party who had no obligation to the disclosing Party not to disclose such
Information to others; or


 


(e)                                  was independently
developed by the receiving Party without use of the Confidential Information of
the disclosing Party as demonstrated by competent written records.


 


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A Party’s Confidential Information shall not be
deemed to be within any of the foregoing exceptions merely because it is
embraced by general disclosures within such exceptions, nor shall a Party’s
Confidential Information be deemed to be within any of the foregoing exceptions
merely because individual items are in such exceptions.


 


11.2                        Authorised Disclosure


 


To the extent it is necessary or appropriate to
fulfil its obligations or exercise its rights under this Agreement, a Party may
disclose such Confidential Information of the other Party as it is otherwise
obliged under Article 11.1 not to disclose:


 


(a)                                  to its Affiliates,
and to its and their (whether actual or potential) sublicensees, Distributors,
consultants, outside contractors, Third Party Manufacturers and clinical
investigators, on a need-to-know basis and on the condition that such entities
or persons, and their employees and agents, agree in writing to keep the
Confidential Information confidential for the same time periods and to the same
extent as such Party is required to keep such Confidential Information
confidential;


 


(b)                                 to Regulatory
Authorities to the extent that such disclosure is [***] [Confidential Treatment
Required] useful to obtain authorisations to conduct Clinical Studies or Post-Approval
Studies or to file, obtain and maintain Regulatory Approvals and to Manufacture
and Commercialise Antibody Product in the Field;


 


(c)                                  to the extent that
such disclosure is [***] [Confidential Treatment Required] useful in connection
with preparing, filing, prosecuting, maintaining, enforcing and/or defending
UCB Core Patent Rights or ImClone Core Patent Rights or Joint Patent Rights in
accordance with the provisions of Article 10; or


 


(d)                                 in prosecuting or
defending litigation or in establishing rights or enforcing obligations under
this Agreement or in complying with Applicable Law, court or administrative
orders, the rules of any relevant stock exchange or similar governing body or
the U.S. Securities and Exchange Commission; provided,
however, it shall:


 


(i)                                     give reasonable
advance notice to the other Party of such disclosure requirement, to the extent
practicable;


 


(ii)                                  provide a copy of
the proposed disclosure to the other Party;


 


(iii)                               only disclose
Confidential Information of the other Party to the extent necessary; and


 


(iv)                              at the request of
the other Party, use [***] [Confidential Treatment Required] to secure
confidential treatment of such Confidential Information required to be
disclosed, including seeking a protective order, to the extent practicable.


 


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11.3                        Public Announcements


 


Following the Effective Date, the Parties may
issue one or more press releases regarding this Agreement, the timing and
content of which shall be mutually agreed to by the Parties.  Except to the extent required by Applicable
Law or the rules of a relevant stock exchange or similar governing body or as
otherwise permitted in accordance with this Article 11, neither Party shall
make any further public announcements concerning this Agreement or the subject
matter of this Agreement without the prior written consent of the other, [***]
[Confidential Treatment Required].  The
Parties agree to consult with each other reasonably and in good faith with
respect to the text and timing of any press releases prior to its issuance.


 


11.4                        Third Party Obligations


 


Neither Party is obliged to disclose to the
other Party any Information that it receives from a Third Party if to do so
would put the disclosing Party in breach of an obligation owed to such Third
Party.


 


11.5                        Termination of Prior Confidentiality Agreements


 


This Agreement supersedes the Confidentiality
Agreement between the Parties dated March 17, 2004.  All Confidential Information (as defined in
such Confidentiality Agreement as amended and extended) disclosed by a Party to
the other Party under such Confidentiality Agreement shall be deemed to be the
Confidential Information of that disclosing Party under this Agreement and
shall be subject to the terms of this Article 11.


 


11.6                        Publications


 


(a)                                  The Collaboration
Committee (or its appropriate designees) shall determine the strategy for, and
coordinate, the publication and presentation of results of studies of Antibody
Products or other data generated under this Agreement.  Where the Collaboration Committee appoints a
designee to carry out this function, the designee shall submit such strategy to
the Collaboration Committee for approval.


 


(b)                                 Each Party
recognises that the publication of papers regarding results of and other
information regarding activities under this Agreement, including oral
presentations and abstracts, may be beneficial to both Parties, provided such publications are subject to
reasonable controls to protect Confidential Information.  In particular, it is the intent of the
Parties to maintain the confidentiality of any Confidential Information
included in any patent application until such patent application has been
published.  Accordingly, each Party will
have the right to review and approve any paper proposed for publication by the
other Party, including any oral presentation or abstract, which incorporates
data generated under this Agreement or which includes Confidential Information
of the other Party.  Before any such
paper is submitted for publication or an oral presentation is made, the
publishing or presenting Party shall deliver a complete copy of the paper or
materials for oral presentation to the other Party at least [***] [Confidential
Treatment Required] prior to submitting the paper to a publisher or making the


 


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presentation. 
The other Party shall review any such paper and give its comments to the
publishing Party within [***] [Confidential Treatment Required] of the delivery
of such paper to the other Party.  With
respect to oral presentation materials and abstracts, the other Party shall
make [***] [Confidential Treatment Required] to expedite review of such
materials and abstracts, and shall return such items [***] [Confidential
Treatment Required] to the publishing or presenting Party with appropriate
comments, if any, but in no event later than [***] [Confidential Treatment
Required] from the date of delivery to the other Party.  Failure to respond within such [***]
[Confidential Treatment Required] shall be deemed approval to publish or
present.  During the Term, if approval is
not given or deemed given, either Party may refer the matter to the
Collaboration Committee for resolution together with the reasons for
withholding approval.  Notwithstanding
the foregoing, the publishing or presenting Party shall, if and to the extent
consistent with Applicable Law and industry standards, comply with the other
Party’s request to delete references to such other Party’s Confidential
Information in any such paper and will withhold publication of any such paper
or any presentation of same for an additional [***] [Confidential Treatment
Required] in order to permit the Parties to obtain patent protection if either
Party deems it necessary.  Any publication
shall include recognition of the contributions of the other Party according to
standard practice for assigning scientific credit, either through authorship or
acknowledgement, as may be appropriate. 
Each Party shall use [***] [Confidential Treatment Required] to cause
investigators and institutions participating in Clinical Studies and
Post-Approval Studies with which it contracts to agree to terms substantially
similar to those set forth in this Article 11.6, which [***] [Confidential
Treatment Required] shall satisfy such Party’s obligations under this Article
11.6 with respect to such investigators and institutions.


 


12.                               TERM AND TERMINATION


 


12.1                        Term of this Agreement


 


Unless earlier terminated pursuant to this
Article 12, this Agreement shall become effective on the Effective Date and
shall remain in full force and effect on a [***] [Confidential Treatment
Required], provided that if
Antibody Products are only being Developed or Commercialised for Independent
Indications and if there is only one Continuing Party, then if, within [***]
[Confidential Treatment Required] after its election to withdraw with respect
to the last Agreed Indication for an Antibody Product pursuant to Article 8.1,
the Non-Continuing Party has not provided the Continuing Party with an Option
Exercise Notice with respect to at least one Independent Indication for an
Antibody Product pursuant to Article 8.9, the Non-Continuing Party shall be
deemed to have terminated this Agreement pursuant to Article 12.2 and such
Non-Continuing Party shall be the Terminating Party and the Continuing Party
shall be the Remaining Party as provided therein.


 


12.2                        Voluntary Termination of this Agreement


 


Subject to Article 16.1, either Party (the Terminating Party) shall have the right at
any time to terminate this Agreement in its entirety by giving written notice
of termination of this Agreement to the other Party.  If within [***] [Confidential


 


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Treatment Required] of receipt of such termination
notice, the other Party provides the Terminating Party with written notice that
it wishes to continue Development and Commercialisation (as appropriate) of one
or more Antibody Products (whether in Agreed Indications or Independent
Indications), the other Party shall be deemed to be the Remaining Party and the
Terminating Party shall be deemed the Non-Remaining Party for purposes of this
Article 12 and termination shall take effect upon expiry of the Transition
Period.  If the other Party does not
serve such written notice within [***] [Confidential Treatment Required] of
receipt of such termination notice, the Parties shall cease all activities
under this Agreement as expeditiously and as cost effectively as possible with
due regard for patient safety and the rights of any subjects that are
participants in Clinical Studies or Post-Approval Studies and in compliance
with Applicable Law and this Agreement shall terminate on the date on which all
such activities cease and in such circumstances this Agreement shall be
terminated only under this Article 12.2, and no other Article.


 


12.3                        Termination with respect to Competing Products


 


(a)                                  Subject to Article
16.2 and Article 16.4, but without prejudice to any other remedy a Party may
have, a Party (which Party shall be deemed to be the Remaining Party) may
terminate this Agreement by giving written notice of termination to the other
Party (which party shall be deemed to be the Non-Remaining Party or, for the
purposes of this Article 12.3, the Excluded
Party) if the Excluded Party or any of its Affiliates [***]
[Confidential Treatment Required] (as such terms are defined in this Agreement,
except for purposes of this Article 12.3, the term “Antibody Product” as it
appears in any definition of a defined term included in such definitions of
“Clinical Study”, “Development” or “Commercialises” shall be deemed to be
replaced with the term “Antibody Product or Competing Product, as applicable”),
alone or in collaboration with a Third Party, a Competing Product (a Competing Activity).  Such notice of termination shall take effect
in accordance with Article 12.3(c).


 


(b)                                 If the Merging
Party:


 


(i)                                     fails to notify the
other Party of its intention to take one of the actions described in paragraphs
(x) through (z) of Article 16.4 within the [***] [Confidential Treatment
Required] provided for in Article 16.4;


 


(ii)                                  timely notifies the
other Party of its intention to terminate this Agreement but fails to serve a
notice of termination pursuant to Article 12.2 within [***] [Confidential
Treatment Required] of notifying the other Party of such intention;


 


(iii)                               timely notifies the
other Party of its intention to divest such Competing Product but fails to use
all [***] [Confidential Treatment Required] to effect such divestment as quickly
as possible in accordance with Article 16.4(b); or


 


(iv)                              timely notifies the
other Party of its intention to cease all Competing Activities but does not
cease all Competing Activities as expeditiously as possible in accordance with
Article 16.4(a),


 


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the other Party (which Party shall be deemed to
be the Remaining Party) may, on written notice to the Merging Party, in
addition to any other remedies available to it at law or equity, terminate this
Agreement by giving written notice of termination to the other Party.  Such notice of termination shall take effect
in accordance with Article 12.3(c).


 


(c)                                  Any notice of
termination served pursuant to Article 12.3(a) or (b) shall specify whether the
Remaining Party wishes to continue Development or Commercialisation (as
appropriate) of one or more Antibody Products (whether in Agreed Indications or
Independent Indications).  If the
Remaining Party does not wish to continue any such Development or
Commercialisation of Antibody Products, upon service of the notice of
termination, the Parties shall cease all activities under this Agreement as
expeditiously and as cost effectively as possible with due regard for patient
safety and the rights of any subjects that are participants in Clinical Studies
or Post-Approval Studies and in compliance with Applicable Law.  If the Remaining Party wishes to continue any
such Development or Commercialisation of Antibody Products, Article 12.8 shall
apply and termination shall take effect on expiry of the Transition Period.


 


(d)                                 For clarity, this
Article 12.3 shall not apply to ImClone’s (or one of its Affiliate’s)
development programme in respect of one or more Antibodies, including 1121B,
any of which is or may be a Competing Product or otherwise competitive with an
Antibody Product, prior to the date, if any, that ImClone elects to cease such
Competing Activities pursuant to Article 16.2(b).


 


12.4                        Termination for Default


 


(a)                                  In the event that
(i) any representation or warranty made under this Agreement by a Party shall
have been untrue in any material respect and this untruth has a material and
adverse effect on the other Party in relation to this Agreement, or (ii) there
is a material breach or material default of this Agreement by a Party (any
event under (i) or (ii), a Default),
then the Party not in default (the Non-Defaulting
Party) shall have the right to give the other Party (the Defaulting Party) written notice (a Notice of Default), which notice, to be
effective, must state the nature of the Default in reasonable detail and must
request that the Defaulting Party cure such Default within [***] [Confidential
Treatment Required] of the date of such notice (or [***] [Confidential
Treatment Required] of the date of such notice with respect to a payment
Default ) or such longer period as the Non-Defaulting Party may designate in
such notice (the Cure Period).  During any such Cure Period or any extended
period in which the Defaulting Party seeks to cure the Default in accordance with
Article 12.4(c), all of each Party’s respective rights and obligations under
this Agreement, including those in relation to Development, Commercialisation
and Manufacture, shall (to the extent applicable) remain in force and effect.


 


(b)                                 The Cure Period
with respect to a Default shall commence on the date that the Defaulting Party
receives the Notice of Default with respect thereto.


 


(c)                                  If a Default is not
cured within the applicable Cure Period (or, if such Default cannot be cured in
such Cure Period and if the Defaulting Party has not used


 


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[***] [Confidential Treatment Required] to cure
such Default within such period and thereafter diligently continues such
actions, provided that payment
Defaults must be cured within the Cure Period), the Non-Defaulting Party, at
its option, may immediately serve written notice on the Defaulting Party
terminating this Agreement, such termination to take effect in accordance with
Article 12.4(d).


 


(d)                                 Any notice of termination
served pursuant to Article 12.4(c), shall specify whether the Non-Defaulting
Party wishes to continue Development or Commercialisation (as appropriate) of
one or more Antibody Products (whether in Agreed Indications or Independent
Indications).  If the Non-Defaulting
Party does not wish to continue any such Development or Commercialisation of
Antibody Products, upon the notice of termination taking effect, the Parties
shall cease all activities under this Agreement as expeditiously and as cost effectively
as possible with due regard for patient safety and the rights of any subjects
that are participants in Clinical Studies or Post-Approval Studies and in
compliance with Applicable Law and this Agreement shall terminate on the date
on which all such activities cease.  If
the Non-Defaulting Party (which Party shall be deemed to be the Remaining
Party) wishes to continue Development or Commercialisation of Antibody
Products, Article 12.8 shall apply, termination shall take effect upon expiry
of the Transition Period and the Defaulting Party shall be deemed to be the
Non-Remaining Party.


 


12.5                        Termination for Bankruptcy


 


(a)                                  All rights and
licences granted under or pursuant to this Agreement by ImClone or UCB are, and
shall otherwise be deemed to be, licences of rights to “intellectual property”
as defined under bankruptcy laws, rules and regulations in the Territory,
including as defined under Article 101 of the United States Bankruptcy
Code.  The Parties agree that the
Remaining Party (as defined in Article 12.5(b)) shall retain and may fully
exercise all of its rights and elections under bankruptcy laws, rules,
regulations or statutes in the Territory, including the United States
Bankruptcy Code.  The Parties further
agree that, in the event of the commencement of a bankruptcy proceeding by or
against a bankrupt Party the other Party shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any intellectual property
which at that date is known to be necessary or useful to the Development,
Commercialisation, Manufacturing or other exploitation of the Antibody Products
and all embodiments of such intellectual property; and the same, if not already
in the other Party’s possession, shall be promptly delivered to the other
Party: (i) upon any such commencement of a bankruptcy proceeding, upon the
other Party’s written request for the same, unless the non-bankrupt Party (or a
trustee on behalf of the bankrupt Party) elects within [***] [Confidential
Treatment Required] to continue to perform all of its obligations under this
Agreement; or (ii) if not delivered under (a) above, upon the rejection of this
Agreement by or on behalf of the bankrupt Party, upon written request for the
same by the other Party.


 


(b)                                 Without prejudice
to Article 12.5(a), this Agreement may be terminated by a Party (which Party
shall be deemed to be the Remaining Party) upon prior


 


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written notice to the other Party (which Party
shall be deemed to be the Non-Remaining Party) in the event that:


 


(i)                                     the other Party
shall make an assignment for the benefit of its creditors, file a petition in
bankruptcy, petition or apply to any tribunal for the appointment of custodian,
receiver or any trustee for it or a substantial part of its assets, or shall
commence any proceeding under any bankruptcy, reorganisation, arrangement,
readjustment of debt, dissolution or liquidation law, rule, regulation or
statute of any jurisdiction (other than for the purposes of a solvent amalgamation
or reconstruction), in effect from time to time; or


 


(ii)                                  if there shall have
been filed against the other Party any such bona fide petition or application,
or any such proceeding shall have been commenced against it, in which an order
for relief is entered or which remains undismissed for a period of [***]
[Confidential Treatment Required] or more; or


 


(iii)                               if the other Party
by any act or omission shall indicate its consent to, approval of or
acquiescence in any such petition, application or proceeding or order for
relief or the appointment of a custodian, receiver or trustee for it or any
substantial part of its assets, and shall suffer any such custodianship,
receivership or trusteeship to continue undischarged for a period of [***]
[Confidential Treatment Required] or more (each of (i), (ii) and (iii), an Insolvency Event).


 


Notwithstanding the foregoing, this Agreement
shall not be terminated pursuant to this Article 12.5(b) if, within [***]
[Confidential Treatment Required]of receipt of the termination notice described
in this Article 12.5(b), the Party experiencing the Insolvency Event
demonstrates to the other Party that it is not insolvent.  Any notice of termination served pursuant to
this Article 12.5(b) shall specify whether the Remaining Party wishes to
continue Development or Commercialisation (as appropriate) of one or more
Antibody Products, (whether in Agreed Indications or Independent
Indications).  If the Remaining Party
does not wish to continue any such Development or Commercialisation of Antibody
Products, upon receipt of the notice of termination by the other Party, the
Parties shall cease all activities under this Agreement as expeditiously and as
cost effectively as possible with due regard for patient safety and the rights of
any subjects that are participants in Clinical Studies or Post-Approval Studies
and this Agreement shall terminate on the date on which all such activities
cease.  If the Remaining Party wishes to
continue Development or Commercialisation of Antibody Products, Article 12.8
shall apply and termination shall take effect upon expiry of the Transition
Period.


 


12.6                        Termination for Challenging Validity of Core Patents


 


In the event that a Party or any of its
Affiliates (the Challenging Party)
challenges the validity or enforceability of any of the other Party’s Core
Patent Rights, then the Party whose Core Patent Rights are the subject of the
challenge (the Non-Challenging Party)
may give the Challenging Party written notice of its intention to


 


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terminate this Agreement if the Challenging
Party does not withdraw its challenge within [***] [Confidential Treatment
Required] after delivery of such notice. 
If the Challenging Party has not withdrawn its challenge to the validity
or enforceability of the Non-Challenging Party’s Core Patent Rights by the end
of that [***] [Confidential Treatment Required] period, the Non-Challenging
Party may, at its option, terminate this Agreement upon prior written notice to
the Challenging Party.  Upon termination
of this Agreement pursuant to this Article 12.6, the Non-Challenging Party
shall be deemed to be the Remaining Party and the Challenging Party shall be
deemed to be the Non-Remaining Party. 
Any notice of termination served pursuant to this Article 12.6 shall
specify whether the Remaining Party wishes to continue Development or
Commercialisation (as appropriate) of one or more Antibody Products (whether in
Agreed Indication or Independent Indications). 
If the Remaining Party does not wish to continue any such Development or
Commercialisation of Antibody Products, upon the notice of termination taking
effect, the Parties shall cease all activities under this Agreement as
expeditiously and as cost effectively as possible having due regard for patient
safety and the rights of any subjects that are participants in Clinical Studies
or Post-Approval Studies and in compliance with Applicable Law and this
Agreement shall terminate on the date on which all such activities cease.  If the Remaining Party wishes to continue
Development or Commercialisation of Antibody Products, Article 12.8 shall apply
and termination shall take effect upon expiry of the Transition Period.


 


12.7                        Remedies


 


The Parties acknowledge and agree that
termination as provided in this Article 12 is not the exclusive remedy for any
matter underlying a right of termination, but rather remedies are cumulative.


 


12.8                        Consequences of Termination


 


(a)                                  Upon notice of
termination of this Agreement being given under Articles 12.2, 12.3, 12.4, 12.5
or 12.6 where there is a Remaining Party (as defined in the applicable Article)
that wishes to continue with the Development or Commercialisation of any
Antibody Products, the following terms shall apply:


 


(i)                                     The Collaboration
Committee shall promptly meet to devise a transition plan (Transition Plan) which provides for a
prompt, smooth, orderly and cost-effective transition of, and which sets forth
the responsibilities and a timetable for transferring, all Development and
Commercialisation and Manufacturing (to the extent applicable) responsibilities
to the Remaining Party, including those activities set forth in paragraphs (ii)
to (xi) of this Article 12.8(a).  Where
the Collaboration Committee cannot agree on the Transition Plan the matter
shall be resolved pursuant to the dispute resolution process set forth in
Article 15, provided that, except
as otherwise provided in this Article 12.8 or elsewhere in this Agreement, the
Non-Remaining Party shall not be required to perform any Development,
Commercialisation or Manufacturing activities beyond those assigned to it in
the Development Plan, the Commercialisation Plan or the Manufacturing Plan and
in no event shall the Non-Remaining Party be required to incur any expenses
beyond those set forth in the applicable Development Budget, the Commercialisation
Budget or Manufacturing


 


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Plan. 
Except as otherwise agreed by the Parties or as provided in this Article
12.8(a), such transition shall be completed as soon as practicable and, in any
event, shall be no later than [***] [Confidential Treatment Required] from the
date of the relevant termination notice (the Transition
Period), except with respect to any Manufacturing activities
performed by or on behalf of the Non-Remaining Party, which shall continue
after the Transition Period as provided in Article 12.8(a)(vii) and (viii) and
the applicable Manufacturing Agreement or existing supply agreement listed in
Schedule 4.  Such Transition Plan shall
provide for (1) transferring all Development, Manufacturing and
Commercialisation responsibilities to the Remaining Party in all Agreed
Indications and Independent Indications (all such Agreed Indications and
Independent Indications, the Continuing Indications),
and (2) ceasing all Development, Commercialisation and Manufacturing activities
in relation to any Continuing Indications that the Remaining Party wishes to
discontinue, in each case as expeditiously as possible in accordance with this
Article 12 whilst (where appropriate) maintaining a supply of Antibody Products
to meet Development and Commercialisation requirements and minimising
interruption of Development, Commercialisation and Manufacture of Antibody
Products in the relevant Indications.


 


(ii)                                  Until the end of
the Transition Period (and with respect to Manufacturing by the Non-Remaining
Party as provided in paragraph (i) above), the Non-Remaining Party, [***]
[Confidential Treatment Required], shall make its personnel and other resources
[***] [Confidential Treatment Required] available to the Remaining Party as
[***] [Confidential Treatment Required] and shall, by the end of the Transition
Period (and with respect to Manufacturing by the Non-Remaining Party as
provided in paragraph (i) above), transfer copies of all relevant information,
files or data relating to the Antibody Products to the Remaining Party and
assign to the Remaining Party or its designee all rights, title and interest
therein.


 


(iii)                               By the end of the
Transition Period (and with respect to Manufacturing by the Non-Remaining Party
as provided in paragraph (i) above), the Non-Remaining Party, [***]
[Confidential Treatment Required], shall assign and transfer to the Remaining
Party all of its rights, title or interest in or to any regulatory filings and
Regulatory Approvals then in its name (or in the name of any of its Affiliates,
or, unless otherwise agreed by the Parties, in the name of any of its
sublicensees or Distributors or any of their agents) for Antibody Product for
the Continuing Indications (including all INDs and Drug Approval Applications)
and shall notify the appropriate Regulatory Authorities and take any other
action [***] [Confidential Treatment Required] to effect such assignment.  The Remaining Party shall take all actions
[***] [Confidential Treatment Required] to assist in effecting such assignment
and transfer.  If ownership of a
regulatory submission or Regulatory Approval cannot be transferred to the
Remaining Party in any country, the Non-Remaining Party, [***] [Confidential
Treatment


 


98





















 


Required], shall and does hereby grant and
shall cause its Affiliates, and, unless otherwise agreed by the Parties, its
sublicensees and Distributors to grant to the Remaining Party a [***]
[Confidential Treatment Required] licence and right of access, reference and
use to such regulatory submission and Regulatory Approvals for all purposes in
the Field in such country.  If such licence
and right of access, reference and use is not sufficient to permit the
Remaining Party to file a Drug Approval Application and receive Regulatory
Approval or to Develop, use, sell, have sold, offer to sell, resell, import,
export, distribute or otherwise transfer possession of or otherwise
Commercialise or Manufacture the relevant Antibody Product for all purposes in
the Field, or as otherwise requested by the Remaining Party, the Non-Remaining
Party, [***] [Confidential Treatment Required], shall provide the Remaining
Party with the complete data package, including any data referenced therein,
that the Non-Remaining Party, its Affiliates or their Distributors or
sublicensees used in regulatory submissions in such country (including INDs,
Drug Approval Applications and any other filings to or with the applicable
Regulatory Authorities) in order to allow the Remaining Party or its designee
to file such IND and Drug Approval Application and to receive Regulatory
Approval in its or such designee’s own name.


 


(iv)                              By the end of the
Transition Period the Non-Remaining Party shall, at the request of the
Remaining Party, assign its rights or grant sufficient and, to the extent
possible, [***] [Confidential Treatment Required], under all of the
Non-Remaining Party’s rights under any then-existing In-Licences to the extent
the same relates to Developing, Commercialising, Manufacturing, making, having
made, using, selling, having sold, offering to sell or resell, importing,
exporting, distributing or otherwise transferring physical possession of or otherwise
transferring title in or to Antibody Products in the Field and shall not (until
receiving notice that the Remaining Party does not desire such an assignment or
sublicence) terminate or amend any such In-Licence without the Remaining
Party’s prior written consent.  Until
receiving notice that the Remaining Party does not desire an assignment or
sublicence of an In-Licence, the Non-Remaining Party shall continue to comply
with its obligations under Article 9.3 with respect to each such In-Licence.


 


(v)                                 Each Party, [***]
[Confidential Treatment Required], shall destroy or at the other Party’s
request return, all of the other Party’s Confidential Information (other than
with respect to maintaining one (1) archival copy of Confidential Information
relating to any of the same for its legal files, for the sole purpose of
determining its obligations under this Agreement) and Materials and shall
provide the other Party with certification by one of its officers that all such
Confidential Information and Materials have been destroyed or returned to the
other Party, as appropriate, provided
that the Remaining Party shall be entitled to retain all of the Non-Remaining
Party’s Confidential Information and Materials that are [***] [Confidential
Treatment


 


99





















 


Required] to Develop, Commercialise or
Manufacture Antibody Products in the Field in the Territory.


 


(vi)                              The Non-Remaining
Party, [***] [Confidential Treatment Required], shall, at the request and
expense of the Remaining Party, provide the Remaining Party with such
assistance as is [***] [Confidential Treatment Required] to effectuate a smooth
and orderly transition of any such Development, Manufacture and
Commercialisation activities to the Remaining Party or its designee so as to
minimize any disruption of such activities, including, at the request of the
Remaining Party, the assignment (and assumption by the Remaining Party) of any
such Regulatory Approvals and related regulatory documentation and contracts
and the transfer of any such biological materials related to any Antibody
Product, in each case that is the subject of such obligation.  Further, upon the Remaining Party’s request,
the Non-Remaining Party shall provide such technical assistance, [***]
[Confidential Treatment Required], as may [***] [Confidential Treatment
Required]be requested to transfer all manufacturing technology that is or had
been used by or on behalf of the Non-Remaining Party and its Affiliates in
connection with the Manufacture, including process development, of any Antibody
Product.


 


(vii)                           If the
Non-Remaining Party is Manufacturing any Antibody Products it shall continue to
supply the Antibody Products it is then manufacturing to the Remaining Party on
the same terms as applied prior to termination until the earlier of [***]
[Confidential Treatment Required] from the date of termination or such time as
the Remaining Party or a Third Party designated by the Remaining Party assumes
responsibility for Manufacture of such Antibody Products, which it shall have
the right to do, save that the [***] [Confidential Treatment Required]; during
the period of Manufacture by the Non-Remaining Party, the Remaining Party shall
be deemed to have automatically granted to the Non-Remaining Party a [***] [Confidential
Treatment Required] right and licence, to use (y) any Joint Know-How or Joint
Patent Rights and (z) if the Non-Remaining Party is (1) UCB, to use any ImClone
Know How, ImClone Patent Rights, Manufacturing Know How (to the extent
Controlled by ImClone) and Manufacturing Patents (to the extent Controlled by
ImClone) and (2) ImClone, to use any UCB Know-How and UCB Patent Rights
Manufacturing Know How (to the extent Controlled by UCB) and Manufacturing
Patents (to the extent Controlled by UCB) , in each case ((y) and (z)) as [***]
[Confidential Treatment Required] to (and only to) Manufacture and supply such
Antibody Products to the Remaining Party as provided herein.


 


(viii)                        If a Third Party supplier is
Manufacturing any Antibody Products, then the Non-Remaining Party, [***]
[Confidential Treatment Required], shall, at the request of the Remaining
Party, use all [***] [Confidential Treatment Required] to assign to the
Remaining Party, and upon such assignment, the Remaining Party shall assume,
any applicable


 


100





















 


manufacturing agreement and the Non-Remaining
Party[***] [Confidential Treatment Required], shall cooperate with the
Remaining Party at the Remaining Party’s request to participate in any discussions
with such Third Party supplier with respect to such assignment (and assumption)
or the negotiation of any direct agreement with a Third Party supplier, provided that, (x) to the extent the
Remaining Party receives the benefit of any existing Third Party Manufacturing
Agreement or existing supply agreement listed in Schedule 4, the Remaining
Party shall be [***] [Confidential Treatment Required] to the Remaining Party
and (y) if the Remaining Party requests that the Non-Remaining Party terminate
any such agreement with a Third Party supplier, the Remaining Party shall be
responsible for [***] [Confidential Treatment Required] to such Third Party
supplier.  In any event the Non-Remaining
Party, [***] [Confidential Treatment Required], shall, at the request of the
Remaining Party, (1) effect a smooth and orderly transition of all
Manufacturing responsibilities to the Remaining Party or its designee, and (2)
cooperate with the Remaining Party or its designee in the conduct of any such
Manufacturing responsibilities and the exercise of its rights under this
Agreement, such as, for example, exercising any right or enforcing any
obligation under any Manufacturing Agreement with a Third Party supplier and
providing the Remaining Party or its designee with any copies of relevant
documents (including Manufacturing Know How (to the extent within the Control
of the Non-Remaining Party), quantities of all Materials (including master cell
bank) and rights of reference, as necessary to allow the Remaining Party to exercise
its rights under this Agreement.


 


(ix)                                The Non-Remaining
Party,[***] [Confidential Treatment Required], shall:  (y) to the extent permitted by such
agreements, use all [***] [Confidential Treatment Required] to assign its
rights or grant sufficient rights under all other Third Party agreements to the
extent the same relate to an Antibody Product as requested to do so by the
Remaining Party and, upon such assignment, the Remaining Party shall assume
such agreements; and (z) provide [***] [Confidential Treatment Required]
assistance to the Remaining Party to assume management of such agreements.


 


(x)                                   Each Party shall
retain the audit rights specified under this Agreement to the extent reasonably
required to verify the correctness of any amounts payable to it under this
Agreement.


 


(xi)                                The Remaining Party
shall bear all [***] [Confidential Treatment Required].


 


(b)                                 The Non-Remaining
Party shall not be considered in breach of this Article 12 to the extent it
fails to fulfil its obligations under this Article 12.8 because of an
injunction imposed by a court of law arising from an action brought by a Third
Party for infringement of Third Party Patent Rights, Third Party Trademark
rights or other Third Party intellectual property rights, except to the extent that
such injunction results from a breach of the Non-Remaining Party’s


 


101





















 


representations and warranties under Article 13
or, if the Non-Remaining Party is a Manufacturer, a breach of the Non-Remaining
Party’s representations and warranties under any Manufacturing Agreement.


 


(c)                                  Upon termination of
this Agreement for any reason, all of the right, title and interest of the
Non-Remaining Party and its Affiliates in the Product Trademarks shall
automatically be assigned, [***] [Confidential Treatment Required], to the
Remaining Party.  The Remaining Party
shall also have the right, for a reasonable period not to exceed [***]
[Confidential Treatment Required] from the end of the Transition Period, to use
the ImClone Company Marks (if the Remaining Party is UCB) or the UCB Company
Marks (if the Remaining Party is ImClone), as applicable, solely in the selling
of any existing inventory of Antibody Products and using any existing inventory
of Promotional Materials and packaging, [***] [Confidential Treatment
Required], and following the expiration of such [***] [Confidential Treatment
Required] period such inventory shall be destroyed by the Remaining Party, the
Remaining Party shall certify such destruction to the Non-Remaining Party and
the Remaining Party shall immediately cease all use of the Non-Remaining
Party’s Corporate Marks in connection with Antibody Products.  In addition:


 


(i)                                     Upon termination of
this Agreement where ImClone is the Remaining Party, (A) each of the licences
UCB granted to ImClone pursuant to this Agreement (save for those with respect
to the UCB Company Marks) shall automatically upon termination convert to a
[***] [Confidential Treatment Required].


 


(ii)                                  Upon termination of
this Agreement where UCB is the Remaining Party, (A) each of the licences
ImClone granted to UCB pursuant to this Agreement (save for those with respect
to the ImClone Company Marks) shall automatically upon termination convert to a
[***] [Confidential Treatment Required].


 


(iii)                               Upon termination of
this Agreement, if on or before a termination the Non-Remaining Party granted a
sublicence as permitted by Article 9.5 and the applicable sublicensee is not in
breach of its obligations under such sublicence agreement, the sublicence
agreement shall, if the Remaining Party so elects and the sublicence agreement
so permits, be deemed to be a sublicence agreement between the Remaining Party
and the sublicensee.


 


12.9                        [***]
[Confidential Treatment Required]


 


102





















 


 


12.10                 Additional Termination Consequences in the Event of
Termination under Certain Articles


 


(a)                                  In the event of
termination of this Agreement under any Article, (i) not later than [***]
[Confidential Treatment Required] after the date on which such termination
takes effect, the Parties will reconcile Operating Profits and Losses and
promptly make such payments as are necessary to effect such reconciliation, and
(ii) the Non-Remaining Party shall cease to have any right or, except as
provided in Article 12.8 or elsewhere in this Agreement or in a Transition
Plan, obligation to fund or participate in the Development of any Antibody
Product and shall have no right or obligation to share in any Operating Profits
and Losses, [***] [Confidential Treatment Required].


 


(b)                                 Following
termination of this Agreement pursuant to Articles 12.2, 12.3, 12.4 or 12.6, if
the Non-Remaining Party materially breaches the terms of any licence granted by
the Non-Remaining Party to the Remaining Party under Article 12.8(c), the
Remaining Party may, by written notice to the Non-Remaining Party, require the
Non-Remaining Party to remedy that breach and, if such breach has not been
remedied within [***] [Confidential Treatment Required] of receipt of such
written notice, the Remaining Party may, by notice in writing to the Remaining
Party, [***] [Confidential Treatment Required].


 


(c)                                  Following
termination of this Agreement pursuant to any Article, if the Remaining Party
or any of its Affiliates challenges the validity or enforceability of any of
the Non-Remaining Party’s Core Patent Rights or takes the position that the
Development, Manufacture or Commercialisation of Antibody Product falls outside
the claims of the Non-Remaining Party’s Core Patent Rights, then the
Non-Remaining Party may give the Remaining Party written notice of its
intention to terminate the licences granted by the Non-Remaining Party pursuant
to this Agreement if the Remaining Party does not withdraw its challenge or
position within sixty (60) day after delivery of such notice.  If the Remaining Party has not withdrawn its
challenge to the validity or enforceability of, or its position with respect
to, the Non-Remaining Party’s Core Patent Rights by the end of that sixty (60)
day period, the Non-Remaining Party may, at its option, terminate all licences
granted by the Non-Remaining Party to the Remaining Party pursuant to this
Agreement upon prior written notice to the Remaining Party.  Upon such notice the Remaining Party shall
cease all activities being conducted under those licences as expeditiously as
possible having due regard for patient safety and the rights of


 


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any subjects that are participants in Clinical
Studies or Post-Approval Studies and in compliance with Applicable Law.


 


12.11                 Surviving Rights


 


(a)                                  Expiration or
termination of this Agreement shall not relieve the Parties of any obligation
accruing before such expiration or termination. 
Any expiration or termination of this Agreement shall be without
prejudice to the rights of either Party against the other accrued or accruing
under this Agreement before expiration or termination, including the right to
receive any payments due but unpaid before expiration or termination.


 


(b)                                 The following
Articles shall survive expiration or termination of this Agreement, howsoever
caused: [***] [Confidential Treatment Required] to the extent applicable to
activities occurring before or surviving termination and any other provisions
which are expressed to survive expiration or termination or which are required
to give effect to such expiration or termination.  The [***] [Confidential Treatment
Required].  All other rights and
obligations shall terminate.


 


13.                               REPRESENTATIONS, WARRANTIES AND COVENANTS


 


13.1                        Authority and Consents


 


(a)                                  UCB and ImClone
each represent and warrant to the other Party that as of the Effective Date:


 


(i)                                     it has full right,
power and authority to enter into this Agreement and perform its obligations
under this Agreement and has taken all necessary corporate action on its part
required to authorise the execution and delivery of this Agreement and the
performance of its obligations under this Agreement;


 


(ii)                                  to its Knowledge,
this Agreement constitutes a legal, valid and binding obligation of such Party
that is enforceable against it in accordance with its terms subject to all
limitations of bankruptcy, liquidation, principles of equity (including
moratorium and enforcements of creditors’ rights generally), general principles
of equity (including those relating to specific performance, injunctions and
other remedies) and public policy constraints (including those pertaining to
limitations or exclusion of liability, competition law, penalties and
jurisdictional issues including conflicts of law);


 


(iii)                               the execution,
delivery and performance of this Agreement by such Party does not conflict with
any agreement, instrument or understanding to which it is a party or by which
it is bound, nor to its Knowledge violate any law, rule or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it;


 


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(iv)                              such Party has not
granted any rights to any Third Party that would conflict with the rights
granted to the other Party under this Agreement;


 


(v)                                 such Party has the
right to grant the licences, sublicences and other rights granted by it
pursuant to this Agreement; and


 


(vi)                              all employees and
officers (other than administrative and 

non-technical personnel) of it and its Affiliates involved in the Development,
Commercialisation or Manufacture of Antibody Products for Agreed Indications or
Independent Indications have executed agreements requiring assignment to the
Party or its Affiliates of all inventions made during the course of and as a
result of their association with such Party or its Affiliates and obligating
the individual to maintain as confidential the confidential information of such
Party and its Affiliates.


 


(b)                                 UCB and ImClone
each covenant and agree to the other Party that during the Term, neither it nor
its Affiliates will grant any rights to any Third Party that would conflict
with the rights granted to the other Party under this Agreement.


 


(c)                                  UCB and ImClone
each represent and warrant to the other Party that neither it, nor any of its
Affiliates, has been debarred and is not subject to debarment and that it and
they have not used, and covenant that it will not, and will procure that its
Affiliates will not, use, in any capacity, in connection with the services to
be performed under the this Agreement, any person who has been debarred
pursuant to section 306 of the FFDCA, 21 U.S.C. § 335a, or who is the subject
of a conviction described in such section (or under any analogous provisions of
Applicable Law outside the United States).


 


13.2                        Additional Representations and Warranties of ImClone


 


ImClone further represents and warrants to UCB
that as of the Effective Date:


 


(a)                                  [***] [Confidential
Treatment Required];


 


(b)                                 the Patent Rights
set forth in Part 4 of Schedule 1 constitute all of the ImClone Patent Rights
that exist as of the Effective Date;


 


(c)                                  ImClone has
disclosed to UCB the patents, patent applications and the official
correspondence from the corresponding file histories of the ImClone Core Patent
Rights;


 


(d)                                 ImClone has not
received a written notice that ImClone or any of its Affiliates is in material
breach or material default of any of the agreements listed in Part 2 of
Schedule 1, and true, complete and correct copies (with only such redactions as
are necessary to protect confidential and financial information) of all such
agreements have been provided to UCB prior to the Effective Date;


 


(e)                                  ImClone has not
received any written notice from a Third Party alleging that the Development,
Commercialisation and Manufacturing activities contemplated by this Agreement
with respect to Antibody Products will


 


105





















 


infringe any Patent Rights or other
intellectual property or proprietary right of such Third Party, except for
those Patent Rights that are the subject of In-Licences and are included in the
ImClone Patent Rights; and


 


(f)                                    ImClone has made
available to UCB all information of which it has Knowledge relating to Third
Party Patents which may be [***] [Confidential Treatment Required] adverse to
the Development, Commercialisation and Manufacturing activities contemplated by
this Agreement with respect to Antibody Products and which would have affected
UCB’s decision to enter into this Agreement.


 


13.3                        Additional Representations, Warranties and Covenants of UCB


 


UCB further represents and warrants to ImClone
that as of the Effective Date:


 


(a)                                  [***] [Confidential
Treatment Required]


 


(b)                                 the Patent Rights
set forth in Part 3 of Schedule 1 constitute all of the UCB Patent Rights that
exist as of the Effective Date;


 


(c)                                  UCB has disclosed
to ImClone the patents, patent applications and the official correspondence
from the corresponding file histories of the UCB Core Patent Rights;


 


(d)                                 UCB has not
received a written notice that UCB or any of its Affiliates is in material
breach or material default of the agreements listed in Part 1 of Schedule 1,
and true, complete and correct copies (with only such redactions as are necessary
to protect confidential and financial information) of all such agreements have
been provided to ImClone prior to the Effective Date;


 


(e)                                  UCB has not
received any written notice from a Third Party alleging that the Development,
Commercialisation and Manufacturing activities contemplated by this Agreement
with respect to Antibody Products will infringe any Patent Rights or other
intellectual property or proprietary right of such Third Party, except for
those Patent Rights that are the subject of In-Licences and are included in the
UCB Patent Rights;


 


(f)                                    UCB has made
available to ImClone all information of which it has Knowledge relating to
Third Party Patents which may be materially adverse to the Development,
Commercialisation and Manufacturing activities contemplated by this Agreement
with respect to Antibody Products and which would have affected ImClone’s
decision to enter into this Agreement;


 


(g)                                 UCB has made
available to ImClone all INDs and other filings and all material correspondence
with the Regulatory Authorities relating to Antibody Products in UCB’s
possession as of the Effective Date; and


 


(h)                                 UCB has disclosed
to ImClone all [***] [Confidential Treatment Required] adverse information of
which it has Knowledge with respect to the safety and efficacy of the Antibody
Products or otherwise [***] [Confidential Treatment Required] adverse to the
Development, Commercialisation and Manufacturing activities contemplated by
this Agreement with respect to Antibody Products


 


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and, in each case, which would have affected
ImClone’s decision to enter into this Agreement.


 


13.4                        Disclaimer of Representation and Warranty


 


(a)                                  Nothing in this
Agreement shall be construed as a warranty or representation by either Party:


 


(i)                                     that the
Development, Commercialisation, Manufacture, making, having made, using,
selling, having sold, offering to sell or reselling, importing, exporting,
distributing or otherwise transferring physical possession of or otherwise
transferring title in or to any Antibody Product under, or in connection with,
this Agreement is or will be free from infringement of, or that the activities
conducted pursuant to this Agreement will not infringe, Patent Rights,
copyrights, Trademarks, industrial design or other intellectual property rights
of any Third Party; or


 


(ii)                                  that any Antibody
Product Developed, Manufactured, Commercialised, made, made on its behalf,
used, sold, sold on its behalf, offered to be sold or resold, imported,
exported, distributed or with respect to which physical possession was
otherwise transferred or with respect to which title in or to was otherwise
transferred under this Agreement is or will be effective, valuable, safe,
non-toxic or patentable.


 


Each Party acknowledges and agrees that the
activities conducted pursuant to this Agreement and the Antibody Products are
experimental as of the Effective Date. 
EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, EACH PARTY EXPRESSLY
DISCLAIMS, WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF EFFICACY, SAFETY, MERCHANTABILITY, SATISFACTORY
QUALITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO ANY MATTER
ARISING IN CONNECTION WITH THIS AGREEMENT, INCLUDING ANY ACTIVITIES CONDUCTED HEREUNDER,
OR ANY ANTIBODY PRODUCTS.


 


(b)                                 Notwithstanding
anything to the contrary in this Agreement, there shall be no limit or
exclusion of any Party’s liability for fraud or for death or personal injury
caused by that Party’s own negligence or wilful misconduct.


 


14.                               INDEMNIFICATION AND INSURANCE


 


14.1                        Indemnification


 


(a)                                  Subject to Article
14.1(b) and Article 14.1(c), each Party agrees to save, defend and hold the
other Party, its Affiliates and their respective directors, officers, agents
and employees (collectively, the Indemnitees)
harmless from and against any and all losses, damages, liabilities,
settlements, penalties, fines, costs and expenses (including, [***]
[Confidential Treatment Required] attorneys’ fees and expenses) payable to a
Third Party (collectively, Losses)
arising out of any Third Party claims, suits, actions or demands (collectively,


 


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Third Party
Claims) resulting directly or indirectly from the
Development, Manufacturing, Commercialisation, use, handling, storage, sale or
other disposition of Antibody Products by the indemnifying Party, its
Affiliates, or any of their respective Distributors, sublicensees or other
agents (other than the Indemnitees), but only to the extent such Losses result
from:


 


(i)                                     [***] [Confidential
Treatment Required] of the indemnifying Party, any of its Affiliates, or any of
their respective Distributors, sublicensees or other agents (other than the
Indemnitees);


 


(ii)                                  any claim of
intellectual property infringement arising from the indemnifying Party’s use of
the other Party’s Corporate Marks in a manner not permitted by this Agreement;


 


(iii)                               any breach of
Applicable Law by the indemnifying Party, any of its Affiliates or any of their
respective Distributors, sublicensees or other agents (other than the
Indemnitees) in performing any activities in connection with this Agreement;


 


(iv)                              any breach by the
indemnifying Party or any of its Affiliates of this Agreement any Manufacturing
Agreement, any agreement listed in Schedule 4 or any In-Licence entered into
prior to the Effective Date; or


 


(v)                                 the Development or
Commercialisation of an Antibody Product for Independent Indications by the
indemnifying Party, any of its Affiliates or any of their respective Distributors,
sublicensees or other agents (other than the Indemnitees) to the extent the
indemnifying Party is the Continuing Party with respect thereto and only with
respect to Third Party Claims made prior to the date the Non-Continuing Party
Converts such Independent Indication to a Converted Agreed Indication pursuant
to Article 8.9,


 


in each case, save to the extent that such
Losses result from [***] [Confidential Treatment Required] of any of the
Indemnitees or breach by any of the Indemnitees of this Agreement, any
Manufacturing Agreement, any of the existing supply agreements listed in
Schedule 4 or any In-Licence.  [***]
  [Confidential Treatment Required].


 


(b)                                 Upon termination of
this Agreement, where there is a Remaining Party, the Remaining Party agrees to
save, defend and hold the Non-Remaining Party, its Affiliates and their
respective directors, officers, agents and employees (the Non-Remaining Party Indemnitees) harmless
from and against any and all Losses arising out of any Third Party Claims to
the extent that such Losses result directly or indirectly from:


 


(i)                                     the Development,
Commercialisation, Manufacture, use, handling, storage, sale, offer to sell,
resale, importation, exportation, distribution or other disposition or transfer
of physical possession of any Antibody Product by the Remaining Party, its
Affiliates, or any of their respective Distributors, sublicensees or other
agents (other than the


 


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Non-Remaining Party Indemnitees) (collectively,
Representatives) after the
effective date of termination of this Agreement except to the extent that such Losses result directly
or indirectly from the Manufacture or supply of Antibody Product by or on behalf
of the Non-Remaining Party or its Affiliates that does not meet the Antibody
Product Standards or was not Manufactured in accordance with Applicable Law;


 


(ii)                                  the use of the
Non-Remaining Party’s Corporate Marks after the effective date of termination,
save as permitted by Article 12.8(c); or


 


(iii)                               any act or omission
of the Remaining Party after the effective date of termination that results in
the Non-Remaining Party being in breach of any In-Licence, any Third Party
manufacturing agreement or any other Third Party agreement with respect to
which the Non-Remaining Party, in accordance with Article 12.8(a)(iv), (viii)
or (ix) (as applicable), remains a party after the effective date of
termination,


 


in each case, save to the extent such Losses
result from [***]   [Confidential Treatment Required]. of any
Non-Remaining Party Indemnitee or any breach by the Non-Remaining Party or its Affiliates of this
Agreement or any agreement referred to in paragraph (iii) above (save for any
such breach resulting from any act or omission of the Remaining Party after
the effective date of termination).


 


(c)                                  The indemnity under Article 14.1(a) shall not apply to
Losses arising out of Third Party Claims resulting directly or indirectly from
Manufacturing activities conducted by any Third Party supplier pursuant to a
Manufacturing Agreement to which both UCB and ImClone are parties.  The indemnity under Article 14.1(a) shall
apply to Losses arising out of Third Party Claims resulting directly or
indirectly from Manufacturing activities conducted by any Third Party supplier
pursuant to a Manufacturing Agreement or an existing supply agreement listed in
Schedule 4, to which only the indemnifying Party is a party, provided that:


 


(i)                                     [***]   [Confidential Treatment Required]; and


 


(ii)                                  [***]   [Confidential Treatment Required].


 


(d)                                 In the event that
either Party receives notice of a Third Party Claim with respect to an Antibody
Product in the Territory, such Party shall inform the other Party as soon as
reasonably practicable.  The Parties
shall confer on how to respond to the Third Party Claim and how to handle the
Third Party Claim in an efficient manner.


 


(e)                                  In the event that a
Party is seeking indemnification under this Article 14 it shall inform the
indemnifying Party of a Third Party Claim as soon as reasonably practicable
after it receives notice of the Third Party Claim, shall permit the
indemnifying Party (at the indemnifying Party’s option) to assume direction and
control of the defence of the Third Party Claim (including the right to settle
the claim solely for monetary consideration), shall co-operate as


 


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requested ([***]   [Confidential Treatment
Required]) in the defence of the Third Party Claim, and shall not settle or
compromise the Third Party Claim without the express written consent of the
indemnifying Party, [***]   [Confidential Treatment Required].


 


14.2                        Insurance


 


Beginning on the first date after the Effective
Date that an [***]   [Confidential Treatment Required], UCB and ImClone
shall each use its [***]   [Confidential Treatment Required] to procure
and maintain, [***]   [Confidential Treatment Required], the following
insurance coverages:


 


(a)                                  Public and Product
Liability, including coverage for products and completed operations (including
coverage for advertising and personal injury), which is maintained for a period
of at least [***]   [Confidential Treatment Required].  The policy shall have a limit of no less than
[***]   [Confidential Treatment Required].


 


(b)                                 Foreign Local
Coverage:  Where required by Applicable
Law for the activities of either Party with respect to Antibody Products, such
Party shall effect foreign local coverages in an amount [***]  
[Confidential Treatment Required];


 


provided that, to
the extent that such insurance covers [***]   [Confidential Treatment
Required].  The Parties will discuss the
availability of insurance coverage for each [***]   [Confidential
Treatment Required].  Unless otherwise
agreed each Party shall obtain insurance for [***]   [Confidential
Treatment Required].


 


All policies under (a) and (b) above shall be
written by insurance companies with an [***]   [Confidential Treatment
Required].  Each Party shall provide to
the other Party a copy of the corresponding certificate of insurance or
broker’s certificate evidencing such coverages and shall notify the other Party
if at any time any insurance coverage effected pursuant to this Article 14.2 is
voided or cancelled.


 


15.                               DISPUTE RESOLUTION


 


15.1                        Committees and Chief Executive Officer Review


 


The Parties recognise that disputes as to
certain matters may from time to time arise during the Term which relate to
either Party’s rights and/or obligations under this Agreement and which are not
resolved by the Collaboration Committee. 
It is the objective of the Parties to establish procedures to facilitate
the resolution of disputes arising from, concerning or in any way relating to
this Agreement or the collaboration (whether or not such dispute gives rise to
a right to terminate this Agreement) (each a Dispute)
in an expedient manner by mutual co-operation and without resort to
litigation.  Unless otherwise expressly
provided in this Agreement (including pursuant to Article 4.7(c)), all Disputes
shall be decided pursuant to this Article 15.


 


(a)                                  Unless otherwise
expressly provided in this Agreement, all Disputes (including any dispute
within the JDT, JCT, JMT or JPC) shall first be


 


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referred to the Collaboration Committee for
resolution in accordance with the provisions of Article 3.3(a).


 


(b)                                 If the
Collaboration Committee is unable to resolve any Dispute within [***]  
[Confidential Treatment Required] after such matter was first referred to or
considered by the Collaboration Committee, whichever is earlier, or in such
longer period of time as the Parties may agree:


 


(i)                                     if the Dispute
falls within Article 15.2, it may be resolved [***]   [Confidential Treatment Required] by the
Party [***]   [Confidential Treatment
Required] in accordance with that Article;


 


(ii)                                  subject to Article
15.1(b)(iii), if neither Party is entitled to resolve such Dispute [***]   [Confidential Treatment Required] in
accordance with Article 15.2, then such matter shall, at the written request of
either Party, be referred to the Chief Executive Officers of each of the
Parties as soon as practicable but in any event no later than [***]   [Confidential Treatment Required] after such
request.  Each Chief Executive Officer
shall have the right to engage the services of any number of independent
experts in the field in question (such independent expert(s) to be engaged
under obligations of confidentiality and non-use equivalent to those set forth
in Article 11 and at the [***]  
[Confidential Treatment Required]) to assist the Chief Executive Officer
in making a determination on the unresolved Dispute, and each Chief Executive
Officer shall consider in good faith the analyses and opinions of any such
independent experts engaged by either of them in making a determination.  If the Chief Executive Officers are unable to
resolve the Dispute within [***]  
[Confidential Treatment Required] after such referral, or such longer period
as the Chief Executive Officers may agree, the matter shall be resolved pursuant
to Article 15.3, except as otherwise provided in Article 15.5; or


 


(iii)                               if the Dispute
relates to the characterization of any Information, Materials or Patent Rights
as ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and Joint
Patent Rights it shall be resolved by an expert in accordance with Article
15.6.


 


15.2                        [***]   [Confidential
Treatment Required]


 


(a)                                  Subject to Articles
15.2(b) and 15.2(c), any Dispute listed in this Article 15.2(a) may, if it has
not been resolved by the Collaboration Committee in accordance with Article
15.1(b), be resolved [***]  
[Confidential Treatment Required]:


 


(i)                                     a Dispute regarding
the proposed implementation of the Development Plan for an Antibody Product for
an Agreed Indication, provided
that the proposed implementation of the Development Plan is within the scope of
that Development Plan and the Development Budget and is not a Dispute regarding
Manufacturing.  [***]   [Confidential Treatment Required];


 


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(ii)                                  a Dispute regarding
the Development of an Antibody Product for an Independent Indication.  [***]  
[Confidential Treatment Required];


 


(iii)                               a Dispute regarding
Commercialisation other than:  (A) a
Dispute regarding Manufacturing or (B) a Dispute as to whether either Party has
used [***]   [Confidential Treatment
Required] to Commercialise an Antibody Product in the countries for which it is
Territorial Lead.  [***]   [Confidential Treatment Required];


 


(iv)                              a Dispute regarding
proposed implementation of the Manufacturing Plan, provided that the proposed implementation of the
Manufacturing Plan is within the scope of that Manufacturing Plan, the
Development Budget and the Commercialisation Budget, and provided  further
that such Dispute does not relate to: 
[***]   [Confidential Treatment
Required];


 


(v)                                 a Dispute regarding
the depiction of a Party’s own Corporate Mark on any Promotional Materials,
packaging or Product Labelling for Antibody Products.  [***]  
[Confidential Treatment Required];


 


(vi)                              a Dispute regarding
the formulation of the Transition Plan, provided
that the aspects of the proposed Transition Plan in issue are consistent with
the Development Plan, the Manufacturing Plan and the Commercialisation
Plan.  [***]   [Confidential Treatment Required]; and


 


(vii)                           a Dispute regarding
the formulation of the transfer plan in accordance with Article 8.6, provided that the aspects of the proposed
transition plan in issue are consistent with the Development Plan, the
Manufacturing Plan and the Commercialisation Plan.  [***]  
[Confidential Treatment Required].


 


(b)                                 Notwithstanding
Article 15.2(a), the Parties agree that:


 


(i)                                     [***]  
[Confidential Treatment Required];


 


(ii)                                  [***]  
[Confidential Treatment Required];


 


(iii)                               [***]  
[Confidential Treatment Required];


 


(iv)                              [***]  
[Confidential Treatment Required];


 


(v)                                 [***]  
[Confidential Treatment Required]; and


 


(vi)                              [***]  
[Confidential Treatment Required].


 


(c)                                  The Parties shall
make all decisions with respect to Disputes subject [***]   [Confidential
Treatment Required].


 


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15.3                        Mediation


 


If pursuant to Article 15.1(b)(ii), the Chief
Executive Officers are not able to resolve a dispute as described therein
within [***]   [Confidential Treatment
Required], or such longer period as the Chief Executive Officers may agree (the
CEO Period), then the Parties
agree to try in good faith to resolve the dispute by non-binding mediation for
a period not to exceed [***]  
[Confidential Treatment Required], or such longer period as the Parties
may agree, from the date of a written request by either Party to do so, provided such request is made within
[***]   [Confidential Treatment Required]
after the end of the CEO Period.  The
mediation shall be conducted by [***]   [Confidential Treatment Required]
to be appointed expeditiously by [***]   [Confidential Treatment Required]
which mediation shall be administered in accordance with the [***]   [Confidential Treatment Required] mediation
rules, except to the extent such rules conflict with any provision of this
Article 15.3 in which event such rules shall be waived and the applicable
provision of this Article 15.3 shall apply. 
Unless otherwise mutually agreed upon by the Parties, the mediation
proceedings shall be conducted in [***]  
[Confidential Treatment Required] and conducted in English.  The Parties agree that they shall [***]   [Confidential Treatment Required].  [***]  
[Confidential Treatment Required]. 
If the dispute remains unresolved after such sixty ([***]   [Confidential Treatment Required], then
either Party shall have the right to resolve such dispute pursuant to Article
15.4.


 


15.4                        Arbitration


 


If the Parties are unable to resolve a dispute
pursuant to Article 15.3, then, except as provided in Articles 15.5 and 15.6,
they shall, at the written request of either Party, enter into arbitration
under the terms of this Article 15.4. 
Within [***]   [Confidential Treatment
Required] of delivery of notice from one Party to the other initiating
arbitration under this Article 15.4, each Party shall select one disinterested,
conflict-free, neutral with relevant expertise in the field of drug development
if the dispute relates to Development or in the field of drug commercialisation
if the dispute relates to Commercialisation or such other field(s) as may be
relevant to the dispute, to serve on an arbitration panel to resolve the
issue.  The neutral selected by a Party
shall not be a past or present employee of or consultant to such Party or of
any Affiliate of such Party.  The members
of the panel selected by the Parties shall, within [***]   [Confidential Treatment Required] of their
selection, select a third disinterested, conflict-free neutral to chair the
panel who shall be a lawyer of not less than [***]   [Confidential Treatment Required] standing
with experience in the pharmaceutical industry and who shall not be a past or
present employee of or consultant to either Party or any Affiliate of such
Party.  If the members of the panel
selected by the Parties cannot, within [***]  
[Confidential Treatment Required] of their selection, agree on a third
member, the Parties shall request that the [***]   [Confidential Treatment Required] select the
third disinterested, conflict-free member who shall meet the requirements for
the third member specified in this Article 15.4.  Consistent with the objective of concluding
the proceeding expeditiously, the panel may require and facilitate such
discovery as it shall determine is appropriate in the circumstances, taking
into account the needs of the Parties and the desirability of making discovery
expeditious and cost-effective.  The
panel may issue orders to protect the confidentiality of Confidential
Information disclosed in discovery.  Each
Party shall then have [***]  
[Confidential Treatment Required] to submit to the panel a written


 


113





















 


statement of such Party’s position on the
issue, which statements shall be provided to the other Party
simultaneously.  Each Party shall, within
[***]   [Confidential Treatment Required]
of receipt of the other Party’s written statement, submit to the panel a
written reply, which statements shall be provided to the other Party simultaneously.  The panel shall, within [***]   [Confidential Treatment Required] after
receipt of both Parties’ written replies, hold a joint meeting on the issue at
which each Party will have an opportunity to make a presentation and to respond
to the other Party’s presentation. 
Within [***]   [Confidential
Treatment Required] of the conclusion of the meeting, the panel shall render
its decision in writing.  The panel may
extend any of the foregoing time limitations to the extent necessary to conduct
such arbitration in a fair and equitable manner with due regard for the
objective of concluding the proceeding expeditiously.  The prevailing Party may enter such decision
in any court having competent jurisdiction. 
The decision of the panel shall be binding on both Parties and shall not
be subject to appeal.  [***]  
[Confidential Treatment Required].  The
costs of the third panel member shall [***]   [Confidential Treatment
Required].  Any arbitration shall be held
in [***]   [Confidential Treatment
Required], conducted in English, and conducted under the rules of the
[***]   [Confidential Treatment Rrequired],
except to the extent such rules conflict with any provision of this Article
15.4 in which event the applicable provision of this Article 15.4 shall apply.


 


15.5                        Matters to proceed to Court


 


(a)                                  Notwithstanding the
foregoing: (i) any dispute relating to the determination of validity,
enforceability or infringement of a Party’s Patent Rights or Trademarks shall
not be submitted to arbitration but shall instead be submitted exclusively to
the courts in the jurisdiction of the relevant Patents or Trademarks, and the
Parties consent to the jurisdiction of such courts and (ii) nothing in this
Agreement shall prohibit a Party from seeking interim relief in any court of
competent jurisdiction.


 


(b)                                 With respect to any
dispute relating to the determination of validity, enforceability or
infringement of a Party’s Patent Rights or Trademarks, the Parties hereby
irrevocably and unconditionally waive any objection to the laying of venue of
any action, suit or proceeding (other than appeals therefrom) with respect to
such disputes in the courts in the jurisdiction of the relevant Patents or
Trademarks, and hereby further irrevocably and unconditionally waive and agree
not to plead or claim in any such court that any such action, suit or
proceeding brought in any such court has been brought in an inconvenient forum.


 


(c)                                  Each Party further
agrees that service of any process, summons, notice or document by registered
mail to its address set forth in Article 17.2, or any other lawful means, shall
be effective service of process for any action, suit or proceeding brought
against it in any such court with respect to any dispute relating to the
determination of validity, enforceability or infringement of a Party’s Patent Rights
or Trademarks.


 


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15.6                        Expert Determination of Disputes regarding Characterisation
of Intellectual Property


 


If the Parties are unable to resolve a Dispute
relating to the characterisation of any Information, Materials or Patent Rights
as ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and Joint
Patent Rights, the Parties shall upon written request by either Party to the
other Party, promptly negotiate in good faith to appoint a mutually acceptable
disinterested, conflict-free individual not affiliated with either Party, with
relevant experience necessary to resolve such dispute (an Expert). 
If the Parties are not able to agree within [***]   [Confidential Treatment Required] after the
receipt by a Party of the written request in the immediately preceding
sentence, the [***]   [CONFIDENTIAL
TREATMENT REQUIRED], or such other similar entity as the Parties may agree,
shall be responsible for selecting an Expert within [***]   [Confidential Treatment Required] of being
approached by a Party.  The fees and
costs of the Expert and the [***]  
[CONFIDENTIAL TREATMENT REQUIRED] (or such other entity) shall be [***]   [Confidential Treatment Required].  Within [***]  
[Confidential Treatment Required] after the designation of the Expert,
the Parties shall each simultaneously submit to the Expert and one another a
written statement of their respective positions on such disagreement.  Each Party shall have [***]   [Confidential Treatment Required] from
receipt of the other Party’s submission to submit a written response thereto,
which shall include any scientific and technical information in support
thereof.  The Expert shall have the right
to meet with the Parties, either alone or together, as necessary to make a
determination.  No later than [***]   [Confidential Treatment Required] after the
designation of the Expert, the Expert shall make a determination by selecting the
resolution [***]   [Confidential
Treatment Required] and shall provide the Parties with a written statement
setting forth the basis of the determination in connection therewith.  The decision of the Expert shall be final and
conclusive, absent manifest error.


 


16.                               IMCLONE OPTION; COMPETING PRODUCTS


 


16.1                        [***]   [Confidential Treatment Required].


 


16.2                        The
Parties acknowledge that ImClone (or one of its Affiliates) is currently
conducting a development programme in respect of one or more Antibodies,
including 1121B, any of which is or may be a Competing Product or otherwise
competitive with an Antibody Product.  By
the date (the Opt-Out Date) which
is the earlier of (a) [***]  
[Confidential Treatment Required] after the date of acceptance by the
FDA for filing of the first Drug Approval Application in respect of any
Antibody Product in the United States and (b) the fifth anniversary of the
Effective Date, ImClone shall either:


 


(a)                                  terminate this
Agreement pursuant to Article 12.2, in which event, for the avoidance of doubt,
ImClone and its Affiliates shall continue to have the right to develop, and,
effective upon the date of such notice, the right to make, have made, use,
sell, have sold, offer to sell, resell, import, export, distribute, otherwise
transfer physical possession of or otherwise transfer title in or to or
otherwise commercialise Competing Products, including 1121B, regardless of any
applicable Transition Period and notwithstanding anything to the contrary in
this Agreement; or


 


115





















 


(b)                                 cease (and procure
that all of its Affiliates cease) all Competing Activities, including in
relation to 1121B, and undertake to UCB that, subject to Article 16.4, it shall
not and shall procure that its Affiliates shall not thereafter engage in any
Competing Activities.  If on or after the
Opt-Out Date, ImClone or any of its Affiliates is engaged in any Competing
Activities, including in respect of 1121B, UCB may, subject to Article 16.4,
terminate this Agreement pursuant to Article 12.3.


 


16.3                        If,
prior to the Opt-Out Date, ImClone provides UCB with a written (i) confirmation
that ImClone and its Affiliates have ceased all Competing Activities; and (ii)
undertaking that it will not (and will procure that all of its Affiliates will
not) thereafter engage in any Competing Activities during the Term, then (and
in any event on and after the Opt-Out Date), (x) to the extent that at that
time UCB or its Affiliates are engaged in any Competing Activity, within
[***]   [Confidential Treatment Required]
of receipt of such notice (or such date), UCB and its Affiliates shall cease
all Competing Activities, and (y) UCB shall, and does hereby, undertake to
ImClone that it will not (and will procure that all of its Affiliates will
not), subject to Article 16.4, thereafter engage in any Competing Activities
during the Term.  If on or after the date
that is [***]   [Confidential Treatment
Required] after receipt of such notice, UCB or any of its Affiliates is engaged
in Competing Activities, ImClone may, subject to Article 16.4, terminate this
Agreement pursuant to Article 12.3.


 


16.4                        If
either Party or any of its Affiliates (to the extent that such Affiliate
remains an Affiliate of a Party (or its successor, if applicable) immediately
after the effective date of such transaction) merges or consolidates with, is
otherwise acquired by, or acquires, a Third Party or otherwise undergoes a
similar transaction and if such Third Party (or any of its Affiliates) is as of
the effective date of such transaction engaged, directly or indirectly, in a
Competing Activity this Article 16.4 (and not Articles 16.2(b) and 16.3) shall
apply.  The merging or consolidating
Party (or its successor), or the acquired Party or its acquirer, as the case
may be (including their Affiliates, as applicable), (collectively the Merging Party) shall, within [***]   [Confidential Treatment Required] after such
date, notify the other Party whether it intends to: (x) cease permanently, or
cause its acquirer or acquiree to cease permanently, all Competing Activities;
(y) divest, or cause its acquirer or acquiree to divest, whether by licence or
otherwise, the Competing Product; or (z) terminate this Agreement pursuant to
Article 12.2.


 


(a)                                  If the Merging
Party either notifies such other Party in writing within such [***]   [Confidential Treatment Required] period
that it intends to cease permanently, or cause its acquirer or acquiree to
cease permanently, all conduct of the Competing Activities, the Merging Party
shall (i) cease all Competing Activities as expeditiously as possible with due
regard for patient safety and the rights of any subjects that are participants
in any clinical studies or post-approval studies relating to the Competing
Product and Applicable Law; and (ii) keep the other Party reasonably informed
of its efforts and progress in effecting such cessation of activities until it
is completed, and shall provide a written summary of such efforts each Calendar
Quarter until completed.


 


(b)                                 If the Merging
Party notifies such other Party in writing within such [***]   [Confidential Treatment Required] period
that it intends to divest such


 


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Competing Product, the Merging Party shall use
all [***]   [Confidential Treatment
Required] to effect such divestiture as quickly as possible and shall keep the
other Party reasonably informed of its efforts and progress in effecting such
divestiture until it is completed, and shall provide a written summary of such
efforts each Calendar Quarter until completed. 
If the Merging Party effects such divestiture by way of one or more
sublicences, the Merging Party shall be entitled [***]   [Confidential Treatment Required].  In addition, the Merging Party shall have the
right to take back rights to such Competing Product if the licensee materially
breaches its obligations under its licence agreement with the Merging Party (in
which event such Competing Product shall again become subject to the terms of
this Article 16.4).


 


16.5                        Notwithstanding
Articles 16.2, 16.3, and 16.4, the Parties shall be entitled to Develop
[***]   [Confidential Treatment Required]
any Competing Product up to and including [***]   [Confidential Treatment Required]the Party
Developing such Competing Product (the Developing
Party) shall provide to the other Party (the Non-Developing Party) (via the JDT) a
complete Data Package for such Competing Product (to the extent such
information is available to [***]  
[Confidential Treatment Required] by the Developing Party).


 


(a)                                  The Non-Developing
Party shall have the right on written notice to the Developing Party (a CP Conversion Notice) within [***]   [Confidential Treatment Required] of receipt
of such Data Package to convert such Competing Product into an Antibody Product
(such conversion from a Competing Product to an Antibody Product, a CP Conversion).  In connection with the exercise of any such
CP Conversion, the Non-Developing Party shall have the right, on written notice
to the Developing Party, to request additional information.  Within [***]  
[Confidential Treatment Required] of receipt of such request, the
Developing Party shall provide the Non-Developing Party with a statement of the
[***]   [Confidential Treatment Required]
occurring immediately before the date of such request for additional information
and any updates to the complete Data Package that are available[***]   [Confidential Treatment Required] by the
Developing Party.  Within [***]   [Confidential Treatment Required] of receipt
of such information, the Non-Continuing Party shall have the right to provide a
CP Conversion Notice to the Developing Party to convert the applicable
Competing Product into an Antibody Product, provided that if the Non-Developing
Party fails to serve such CP Conversion Notice within such [***]   [Confidential Treatment Required]period, the
Non-Developing Party’s CP Conversion right shall be deemed to have lapsed in
respect of such Competing Product and the Non-Developing Party shall have no
further right to convert such Competing Product into an Antibody Product.


 


(b)                                 If the
Non-Developing Party timely delivers a CP Conversion Notice, the Developing
Party shall within [***]   [Confidential
Treatment Required] of receipt of the CP Conversion Notice provide the
Non-Developing Party with an updated statement of all of [***]   [Confidential Treatment Required].  Within [***]  
[Confidential Treatment Required] of receipt of such updated statement,
the Non-Developing Party shall [***]  
[Confidential Treatment Required]. 
If [***]   [Confidential Treatment
Required]


 


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(c)                                  Upon [***]   [Confidential Treatment Required], such
Competing Product shall be deemed to be converted into an Antibody Product for
an Agreed Indication for all purposes under this Agreement, including with
respect to Developmental Costs and Operating Profits and Losses, which shall be
[***]   [Confidential Treatment
Required].  If such conversion does not
take place the provisions of Articles 16.2 and 16.3 shall apply and the
Developing Party shall not engage in any Competing Activities in relation to
such Competing Product, whether alone or with or through any Third Party.


 


16.6                        For
the avoidance of doubt, ImClone and its Affiliates are not licensed to develop,
make, have made, use, sell, have sold, offer to sell, resell, import, export,
distribute, exploit, transfer physical possession of or otherwise transfer
title in or to and shall not develop, make, have made, use, sell, have sold,
offer to sell, resell, import, export, distribute, exploit, transfer physical
possession of or otherwise transfer title in or to any UCB Patent Rights or UCB
Know-How in relation to any Antibody Product other than an Antibody Product
Developed, Manufactured or Commercialised pursuant to this Agreement.


 


16.7                        For
the avoidance of doubt, UCB and its Affiliates are not licensed to develop,
make, have made, use, sell, have sold, offer to sell, resell, import, export,
distribute, exploit, transfer physical possession of or otherwise transfer
title in or to and shall not develop, make, have made, use, sell, have sold,
offer to sell, resell, import, export, distribute, exploit, transfer physical
possession of or otherwise transfer title in or to any ImClone Patent Rights or
ImClone Know-How in relation to any Antibody Product other than an Antibody
Product Developed, Manufactured or Commercialised pursuant to this Agreement.


 


17.                               MISCELLANEOUS


 


17.1                        Amendments


 


This Agreement may not be modified or
supplemented by any purchase order, change order, acknowledgement, order
acceptance, standard terms of sale, invoice or the like.  Any amendment or modification to this
Agreement shall be made in a writing expressly stated for such purpose and
signed by an authorised officer of each Party; except that the Development Plan
and Commercialisation Plan may be amended or updated as expressly permitted by
this Agreement.


 


17.2                        Notices


 


All notices under this Agreement shall be in
writing and shall be deemed given if delivered personally or by facsimile
transmission (receipt verified), mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service, to the
Parties at the following addresses (or at such other address for a Party as
shall be specified by like notice; provided
that notices of a change of address shall be effective only upon receipt).


 


	
  If to UCB, addressed to:

  	
   

  	
  UCB, S.A.

  
	
   

  	
   

  	
  Allée de la Recherche,

  
	
   

  	
   

  	
  60 1070 Brussels

  
	
   

  	
   

  	
  Belgium

  



 


118





















 


	
   

  	
   

  	
  Attention:

  	
  General Counsel

  
	
   

  	
   

  	
  Telephone:

  	
  (32-2) 559.99.99

  
	
   

  	
   

  	
  Fax:

  	
  (32-2) 559.99.00

  
	
   

  	
   

  	
   

  
	
  If to ImClone, addressed to:

  	
   

  	
  ImClone Systems Incorporated

  
	
   

  	
   

  	
  180 Varick Street

  
	
   

  	
   

  	
  New York, NY 10014

  
	
   

  	
   

  	
  United States of America

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Attention:

  	
  General Counsel

  
	
   

  	
   

  	
  Telephone:

  	
  (212) 645-1405

  
	
   

  	
   

  	
  Fax:

  	
  (212) 645-2770

  



 


17.3                        Force Majeure


 


Neither Party shall be held liable or
responsible to the other Party nor be deemed to have defaulted under or
breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement to the extent such failure or delay is caused by or
results from Force Majeure, provided,
however, that the Party so
affected shall use [***]   [Confidential
Treatment Required] to avoid, remove or mitigate such causes of non-performance
and shall continue performance with reasonable dispatch wherever such causes are
removed.  Each Party shall provide the
other Party with prompt written notice of any delay or failure to perform that
occurs by reason of Force Majeure.  Such
excuse shall be continued so long as the condition constituting Force Majeure
continues.  The Parties shall mutually
seek in good faith a resolution of the delay or failure to perform.


 


17.4                        Use of Names, Logos or Symbols


 


Except as otherwise expressly provided in this
Agreement (including with respect to ImClone Company Marks and UCB Company
Marks), neither Party shall use and no rights are granted to the Trademarks
(including the names ImClone and UCB), domain names, physical likeness,
employee names or owner symbols of the other Party for any purpose (including
private or public securities placements) without the prior written consent of
the other Party[***]   [Confidential
Treatment Required].


 


17.5                        Governing Law


 


This Agreement, including any proceedings under
Article 15, shall be governed by and construed in accordance with the laws of
the State of New York, excluding any conflicts or choice of law rule or
principle that might otherwise refer construction or interpretation of this
Agreement to the substantive law of another jurisdiction, other than Section
5-1401 of the New York General Obligations Law. 
The Parties agree to exclude the application to this Agreement of the
United Nations Convention on Contracts for the International Sale of Goods.


 


119





















 


17.6                        Performance by Affiliates


 


(a)                                  Each of UCB and
ImClone acknowledges that obligations under this Agreement may be performed on
a subcontracting basis by their respective Affiliates.  Each of UCB and ImClone remains responsible
for the acts and omissions in the performance of this Agreement of its Affiliates.  To the extent the Parties delegate
responsibility to Affiliates, the Parties agree that such entities may not make
decisions inconsistent with this Agreement.


 


(b)                                 Each Party agrees
that any information or material provided to it or its Affiliates by the other
Party’s Affiliates or subcontractors shall be deemed to be Information or
Materials provided by the other Party.


 


17.7                        Assignment


 


A Party’s rights and obligations under this
Agreement may not be assigned or otherwise transferred by any Party without the
consent of the other Party, [***]   [Confidential Treatment Required]; provided, however,
that either UCB or ImClone may, without such consent, assign its rights and
obligations under this Agreement:


 


(a)                                  to any Affiliate, provided that such interest shall be
retransferred to the relevant Party if such entity ceases to be an Affiliate of
such Party, and provided further
that the assigning Party shall remain responsible for the acts and omissions in
the performance of this Agreement of its Affiliate; or


 


(b)                                 in connection with
a merger, consolidation or sale of substantially all of the business to which
this Agreement relates to an unrelated Third Party of good financial standing.


 


Any assignment or other transfer in violation
of this Article 17.7 shall be void ab initio.


 


17.8                        Subcontracting


 


The Parties acknowledge and agree that,
notwithstanding anything to the contrary in this Agreement, elements of the
work involved in Development, Manufacture and Commercialisation of Antibody
Product may be subcontracted to a Third Party by the responsible Party and that
the granting Party entering into such subcontract may, as part of such
subcontract, grant to such Third Party a right to use ImClone Patent Rights,
ImClone Know-How, ImClone Company Marks, UCB Patent Rights, UCB Know-How, UCB
Company Marks and Product Trademarks, as applicable, only to the extent and
only for so long as such use is necessary for such subcontractor to perform
such tasks; provided, however,
that the responsible Party shall not be relieved of its obligation under this
Agreement and shall remain responsible and liable for the acts and omissions in
the performance of such work by its subcontractors.


 


17.9                        No Strict Construction


 


This Agreement has in its entirety been
prepared jointly by the Parties and not by one Party and the Parties agree that
this Agreement should be construed accordingly (whether in whole or in part)
and no rule of strict construction shall be applied against either Party.


 


120





















 


17.10                 Interpretation and Schedules


 


(a)                                  The captions or
headings of the Articles or other subdivisions of the Articles are inserted
only as a matter of convenience or for reference and shall have no effect on
the meaning of the provisions of this Agreement.


 


(b)                                 Unless otherwise
specified references in this Agreement:


 


(i)                                     to any Article or
Schedule means references to such Article or Schedule of this Agreement;


 


(ii)                                  to any agreement,
instrument or other document in this Agreement refer to such agreement,
instrument or other document as originally executed or, if subsequently varied,
replaced or supplemented from time to time, as so varied, replaced or
supplemented and in effect at the relevant time of the reference to it; and


 


(iii)                               to any person
includes a body corporate and an unincorporated association of persons.


 


(c)                                  Any statute defined
or referred to in this Agreement or in any agreement or instrument or other
document that is referred to in this Agreement means such statute as from time
to time amended, modified or supplemented, including by succession of
comparable successor statutes and references to all attachments to it and
instruments incorporated into any of them. 
Subject to Article 17.7, references to an entity or person are also to
its permitted successors and assigns.


 


(d)                                 All Schedules
annexed to this Agreement or referred to in this Agreement are incorporated
into and made a part of this Agreement as if set out in full in this
Agreement.  Any capitalised terms used in
any Schedule but not otherwise defined in such Schedule, shall have the meaning
as defined in this Agreement.  Any
capitalised terms used in this Agreement but not otherwise defined in this
Agreement, shall have the meaning as defined in Schedule 2.


 


(e)                                  Whenever the words
“include,” “includes” or “including” are used in this Agreement, they shall be
deemed to be followed by the words “without limitation”.  Except where the context requires otherwise,
the word “or” has the inclusive meaning represented by the phrase “and/or.”


 


(f)                                    The provisions of
this Article 17.10 shall apply unless the contrary intention appears.


 


17.11                 Severability


 


If any provision of this Agreement is held to
be illegal, invalid or unenforceable under any present or future law, and if
the rights or obligations of either Party under this Agreement will not be
materially and adversely affected thereby, (a) such provision shall be fully
severable, (b) this Agreement shall be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(c) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable
provision or by its severance


 


121





















 


herefrom, and (d) in lieu of such illegal,
invalid or unenforceable provision, there shall be added automatically as a
part of this Agreement a legal, valid and enforceable provision as similar in
terms to such illegal, invalid or unenforceable provision as may be possible
and [***]   [Confidential Treatment
Required] acceptable to the Parties herein. 
To the fullest extent permitted by Applicable Law, each Party hereby
waives any provision of law that would render any provision prohibited or
unenforceable in any respect.


 


17.12                 No Consequential Damages


 


NEITHER PARTY WILL BE LIABLE FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR RELATING TO THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS UNDER THIS AGREEMENT, OR FOR LOST
PROFITS, ANTICIPATED PROFITS, LOST GOODWILL, LOST REVENUE, LOST PRODUCTION,
LOST CONTRACTS OR LOST OPPORTUNITY, ARISING FROM OR RELATING TO THIS AGREEMENT,
WHETHER DENOMINATED IN OR ARISING IN CONTRACT, TORT OR OTHERWISE REGARDLESS OF
ANY NOTICE OF SUCH DAMAGES.  NOTHING IN
THIS ARTICLE 17.12 IS INTENDED TO LIMIT OR RESTRICT ANY PAYMENT OBLIGATION
EXPLICITLY CONTAINED IN THIS AGREEMENT (INCLUDING THE INDEMNITIES SET OUT IN
ARTICLE 14).


 


17.13                 Equitable Relief


 


Each Party acknowledges and agrees that the
restrictions set forth in Article 11 and Article 17.4 are reasonable and
necessary to protect the legitimate interests of the other Party and that such
other Party would not have entered into this Agreement in the absence of such
restrictions, and that any violation or threatened violation of any provision
of such Articles will result in irreparable injury to such other Party.  Each Party also acknowledges and agrees that
in the event of a violation or threatened violation of any provisions of
Article 11 and Article 17.4 the other Party shall be entitled to preliminary
and permanent injunctive relief, without the necessity of proving irreparable
injury or actual damages and without the necessity of having to post a bond, as
well as to an equitable accounting of all earnings, profits and other benefits
arising from any such violation.  The
rights provided in the immediately preceding sentence shall be cumulative and
in addition to any other rights or remedies that may be available to such other
Party.  Nothing in this Article 17.13 is
intended, or should be construed, to limit such other Party’s right to
preliminary and permanent injunctive relief or any other remedy for breach of
any other provision of this Agreement.


 


17.14                 Change Of Control


 


A Party subject to a Change of Control (the Acquired Party) shall provide written
notice to the other Party (the Non-Acquired
Party), where possible, at least [***]   [Confidential Treatment Required] prior to
the Change of Control or, where not possible, as soon as the impending Change
of Control can be disclosed to the Non-Acquired Party.  Within [***]  
[Confidential Treatment Required] of the receipt of a written notice
pursuant to this Article 17.14, the Chief Executive Officer of each Party shall
meet to discuss the impact of any proposed Change of Control upon the
collaboration and the commercial value of any Antibody Product for an Agreed


 


122





















 


Indication and to discuss the possible nature
of the relationship with the combined entity.


 


17.15                 General Provisions


 


(a)                                  The
representations, warranties, covenants and agreements contained in this
Agreement are for the sole benefit of the Parties and their successors and
permitted assigns, and a person who is not a Party to this Agreement may not
enforce any of its terms.


 


(b)                                 A waiver (whether
express or implied) by one of the Parties of any of the provisions of this
Agreement or of any breach by or default of the other Party in performing any
of those provisions must be in writing executed by a responsible officer of the
Party providing the waiver and expressly waiving such provisions or breach or
default by reference to this Agreement, and any waiver shall not constitute a
continuing waiver, and that waiver shall not prevent the waiving Party from
subsequently enforcing any of the provisions of this Agreement not waived or
from acting on any subsequent breach by or default of the other Party under any
of the provisions of this Agreement.


 


(c)                                  Each Party
undertakes to execute all documents and perform all acts that may be [***]   [Confidential Treatment Required] to give
full effect to this Agreement.


 


(d)                                 Each Party shall
pay its costs and expenses incurred by it in connection with negotiation and
execution of this Agreement.


 


(e)                                  It is expressly
agreed that for all purposes:


 


(i)                                     this Agreement or
any portion of this Agreement shall not be considered to be a partnership
agreement; and


 


(ii)                                  the relationship
between the two Parties shall not constitute an employee-employer, partnership,
joint venture, agency or similar business relationship between the
Parties.  Neither UCB nor ImClone shall
have the authority to make any statements, representations, warranties,
guarantees or commitments (express or implied) of any kind or to take any
action which shall bind the other Party to a Third Party, without the prior
written consent of the other Party to do so. 
Each Party shall use its own discretion with respect to, and shall have
complete and authoritative control over its employees and the methods and means
by which it performs, its activities under this Agreement (including the
management of permitted subcontractors).


 


(f)                                    This Agreement may
be executed in two (2) or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.


 


17.16                 Whole Agreement


 


This Agreement and the Schedules referred to in
this Agreement constitute the entire agreement between the Parties with respect
to the subject matter of this Agreement,


 


123





















 


and supersede all previous understandings,
arrangements and agreements with respect to the subject matter of this
Agreement, whether written or oral.  Each
Party acknowledges that in entering into this Agreement it has not relied on
any representation, warranty, collateral contract or other assurance (except
those expressly set out in this Agreement together with the Schedules) made by
or on behalf of any other Party before the signature of this Agreement.  Each Party waives all rights and remedies
which, but for this Article 17.16, might otherwise be available to it in
respect of any such representation, warranty, collateral contract or other
assurance.


 


17.17                 HSR Filing


 


(a)                                  To the extent necessary at any time
during the term of this Agreement, each of UCB and ImClone will promptly file
with the United States Federal Trade Commission and the Antitrust Division of
the United States Department of Justice, any HSR Filing required of it in the
reasonable opinion of both Parties under the HSR Act with respect to the
transactions contemplated hereby.  The
Parties will co-operate with one another to assess the necessity of any such
HSR Filing and, to the extent necessary, co-operate with one another in the preparation
and management of any such HSR Filing and the outcome thereof.  Each Party will be responsible for its own
costs, expenses, and filing fees (as an acquiring person) associated with any
HSR Filing.


 


(b)                                 In respect of any HSR Filing, each of UCB
and ImClone will use its [***]  
[Confidential Treatment Required] to address any concern on the part of
any court or government authority regarding the legality of the proposed
transaction, including co-operating in good faith with any government investigation
and the prompt production of documents and information demanded by any second
request for documents and of witnesses if requested.


 


 


IN WITNESS WHEREOF, the duly
authorised representatives of the Parties have executed this Agreement as of
the date first set out above.


 


 


	
  UCB S.A.

  	
  IMCLONE SYSTEMS INCORPORATED

  
	
   

  	
   

  
	
  By:

  	
  ROCH DOLIVEUX

  	
   

  	
  By:

  	
  MICHAEL HOWERTON

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  ROCH DOLIVEUX

  	
   

  	
  Name:

  	
  MICHAEL HOWERTON

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  CHAIRMAN OF THE EXECUTIVE COMMITTEE

  	
   

  	
  Title:

  	
  CHIEF FINANCIAL OFFICER

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  ROBERT J. TRAINOR

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  ROBERT J. TRAINOR

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  SENIOR VICE PRESIDENT AND GENERAL COUNSEL

  	
   

  	
   

  	
   

  



 


124





















 


SCHEDULE 1


 


PATENT
RIGHTS AND TRADEMARKS


 


Schedule 1
Part 1: UCB In-Licences


 


1                                          [***]
  [Confidential Treatment Required]


 


 


125





















 


Schedule 1 Part 2: ImClone In-Licences


 


1                                          [***]
  [Confidential Treatment Required]


 


 


126





















 


Schedule 1
Part 3: UCB Patent Rights and UCB Company Marks


 


UCB CORE PATENT RIGHTS


 


[***]   [Confidential Treatment Required]


 


 


127





















 


UCB PATENT RIGHTS


 


[***]   [Confidential Treatment Required]


 


 


128





















 


[***]   [Confidential Treatment Required]


 


 


129





















 


[***]   [Confidential Treatment Required]


 


 


130





















 


[***]   [Confidential Treatment Required]


 


 


131





















 


[***]   [Confidential Treatment Required]


 


 


132





















 


[***]
  [Confidential Treatment Required]


 


 


133





















 


[***]
  [Confidential Treatment Required]


 


 


134





















 


[***]
  [Confidential Treatment Required]


 


 


135





















 


[***]   [Confidential Treatment Required]


 


 


136





















 


UCB COMPANY MARKS


 


The
UCB Company Marks are the word mark “UCB” and the corporate logo set out below.


 





 


137





















 


Schedule 1
Part 4: ImClone Patent Rights and ImClone Company Marks


 


IMCLONE CORE PATENT RIGHTS


 


[***]   [Confidential Treatment Required]


 


[***]   [Confidential Treatment Required]


 


138





















 


IMCLONE PATENT RIGHTS


 


[***]   [Confidential Treatment Required]


 


139





















 


IMCLONE COMPANY MARKS


 


The
ImClone Company Marks are the word mark “IMCLONE SYSTEMS” and the corporate
logo set out below.


 





 


140





















 


SCHEDULE 2


 


FINANCIAL
PLANNING, ACCOUNTING AND REPORTING


 


[***]   [Confidential Treatment Required]


 


141





















 


SCHEDULE 3


 


OUTLINE FOR
THE DEVELOPMENT PLAN


 


[***]   [Confidential Treatment Required]


 


142





















 


SCHEDULE 4


 


EXISTING
SUPPLY AGREEMENTS


 


[***]   [Confidential Treatment Required]


 


143