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, 6 ^th 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

 

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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

 

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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

 

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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.

 

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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.

 

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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.

 

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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.

 

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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).

 

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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.

 

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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

 

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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.

 

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[***]   [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.

 

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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)

 

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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)

 

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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

 

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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)

 

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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,

 

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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

 

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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].

 

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(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

 

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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

 

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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

 

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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;

 

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(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

 

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(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

 

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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

 

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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

 

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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

 

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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

 

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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,

 

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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

 

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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

 

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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.

 

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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

 

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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

 

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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;

 

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(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;

 

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