EXHIBIT 4.6
Development and License Agreement/1/
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Dated February 28, 1999
Between
▇▇▇▇▇ ▇▇
And
Cambridge Antibody Technology
_________________________
/1/ [***] indicates text deleted, which is subject to a confidential treatment
-
request. This text has been filed with the SEC on a supplemental basis.
DEVELOPMENT AND LICENSE AGREEMENT
This Development and License Agreement (the "Agreement") is made this 28th day
of February __, 1999 ("Effective Date") by and between Cambridge Antibody
Technology, Ltd., ("CAT") an English corporation having its registered office at
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇
Aktiengesellschaft, ("▇▇▇▇▇") a corporation organized under the laws of the
Federal Republic of Germany, which is a wholly owned subsidiary of BASF AG, and
which has a place of business at ▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ on Rhine,
Germany.
WHEREAS, ▇▇▇▇▇ and CAT entered into a Development and License Agreement dated
April 1, 1995 (the "Prior Agreement") pursuant to which CAT is to conduct
collaborative research and development for the production of antibodies to
Target-1 (TNF) and Target-2 (IL-12); and
WHEREAS, the Prior Agreement granted ▇▇▇▇▇ the option to have CAT conduct
research on four additional targets; and
WHEREAS, ▇▇▇▇▇ and CAT agree that the Prior Agreement shall remain in full force
and effect solely as to the terms and conditions that relate specifically to
Target-1 (TNF) and Target-2 (IL-12); and
WHEREAS, ▇▇▇▇▇ and CAT agree that this Agreement shall replace the Prior
Agreement as to the terms and conditions under which collaborative research
shall be conducted for Target-3 (IL-18) and may be conducted for potential
targets (Target-4, Target-5 and Target-6).
NOW THEREFORE, in consideration of the mutual promises and covenants contained
in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.00 As used throughout this Agreement, the following initial capitalized terms
shall have the meanings ascribed to them in Sections 1.01 through 1.39.
1.1 "Affiliate(s)" means a corporation or any other entity that directly, or
indirectly through one or more intermediaries, controls, is controlled by, or is
under common control with, the designated party.
1.2 "Antibodies" mean antibody molecules or fragments or derivatives thereof,
identified, produced or derived under the Research Program binding to the
Antigen(s).
1.3 "Antigen(s)" means IL-18.
1.4 "BASF" means BASF Aktiengesellschaft, a corporation organized under the
laws of the Federal Republic of Germany, and having a place of business at
Ludwigshafen, Germany.
1.5 "Boss Patent" means US Patent 4,816,397 and any other US or foreign
patents or patent applications sharing priority applications therewith,
including the "Boss Patent Rights" as defined in the MRC Agreement attached
hereto as Schedule III.
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1.6 "CAT" means Cambridge Antibody Technology, Ltd., an English corporation
having its registered office at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇.
1.7 "CAT Know-How" means all unpatented information, whether or not
patentable, relating to materials, methods, processes, techniques and data,
including Regulatory Data, for the development, manufacture, use or sale of the
Antibodies, Product or Drug, which is known to CAT or its Affiliates, or
developed independently by CAT or its Affiliates, or received by CAT or its
Affiliates from a third party and not from ▇▇▇▇▇, its Affiliates or a
Collaborator or its Affiliates, at any time during the Term of this Agreement
and which CAT is free to transfer or disclose without violating contractual
obligations to any third party.
1.8 "Collaborator" means the party or parties designated by ▇▇▇▇▇ pursuant to
Article 2 of this Agreement.
1.9 "Collaborator Know-How" means all unpatented information, whether or not
patentable, relating to materials, methods, processes, techniques and data,
including Regulatory Data, for the development, manufacture, use or sale of the
Antibodies, Product or Drug, which is known to Collaborator or its Affiliates,
or developed independently by Collaborator or its Affiliates or received by
Collaborator or its Affiliates from a third party and not from CAT or its
Affiliates or ▇▇▇▇▇ or its Affiliates, at any time during the Term of this
Agreement and which Collaborator is free to transfer or disclose without
violating contractual obligations to any third party.
1.10 "Drug(s)" means a drug, which is made, isolated and/or developed by ▇▇▇▇▇
and/or its Affiliates wholly or partly using the Antibodies or derived from the
Antibodies.
1.11 "Effective Date" means February ___, 1999.
1.12 "Exclusive Field" means the isolation, development, manufacture, use and
sale of Antibodies (excluding any antibody that binds to a receptor and that
does not neutralize the action of the ligand on the receptor) for human in vivo
use.
1.13 "FDA" means the United States Food and Drug Administration or any
successor United States governmental agency or any other foreign governmental
agency performing similar regulatory functions with respect to pharmaceutical
products.
1.14 "Field" means the generation of Antibodies directed against human IL-18.
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1.15 "First Commercial Sale" means the first sale or other disposition for
value of the Products, in a final dosage form packaged for the ultimate
consumer, to an independent third party following regulatory approval. The term
"First Commercial Sale" shall not include sales and disposals for experimental
purposes or for purposes of clinically or otherwise testing any Product.
1.16 "IL-18" means the human protein currently identified as Interleukin-18,
previously termed IGIF (interferon gamma inducing factor).
1.17 "Improvement Patent(s)" means any patent or application, including any
United States and foreign counterpart applications, continuing, divisional,
reissue, re-examination and substitute application relating to any Invention,
including any patents and patent applications first disclosing one or more
Antibodies or a Product or a Drug.
1.18 "Invention(s)" means any invention, discovery or development which relates
to the development, manufacture, use or sale of the Antibodies or a Product or
Drug, whether or not patentable, and which is made during the term of this
Agreement, whether solely or jointly by CAT, ▇▇▇▇▇ or its Affiliates, or a
Collaborator, during or within one (1) year after and arising out of the
Research Program.
1.19 "▇▇▇▇▇" means ▇▇▇▇▇ Aktiengesellschaft, a corporation organized under the
laws of the Federal Republic of Germany, which is a wholly owned subsidiary of
BASF, and which has a place of business at ▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ on
Rhine, Germany.
1.20 "▇▇▇▇▇ Know-How" means all unpatented information, whether or not
patentable, relating to materials, methods, processes, techniques and data,
including Regulatory Data, for the development, manufacture, use or sale of the
Antibodies, Product or Drug, which is known to ▇▇▇▇▇ or its Affiliates, or
developed independently by ▇▇▇▇▇ or its Affiliates or received by ▇▇▇▇▇ or its
Affiliates from a third party and not from CAT or its Affiliates or a
Collaborator or its Affiliates, at any time during the Term of this Agreement
and which ▇▇▇▇▇ is free to transfer or disclose without violating contractual
obligations to any third party.
1.21 "Know-How" means CAT Know-How, Collaborator Know-How and ▇▇▇▇▇ Know-How.
1.22 "MRC" means the Medical Research Council of ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇
▇▇▇.
1.23 "MRC-▇▇▇▇▇-Agreement" means the agreement between MRC and ▇▇▇▇▇, dated as
of June 29, 1993, pursuant to which MRC licensed the MRC-Patents to ▇▇▇▇▇; a
copy of which is attached as Schedule III to this Agreement.
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1.24 "MRC-Patents" means [***].
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1.25 "NDA" means a New Drug Application, or other application for the approval
to market Product, which is submitted to the FDA.
1.26 "Net Sales" means the amounts invoiced on the sales of Product by ▇▇▇▇▇,
its sublicensees and Affiliates to independent, unrelated third parties in bona
fide arms length transactions, less the following deductions properly documented
actually allowed and taken by such third parties and not otherwise recovered by
or reimbursed by ▇▇▇▇▇, its Affiliates or sublicensees:
(1) trade, cash and quantity discounts, including charge backs;
(2) taxes on sales (such as sales or use taxes) to the extent added to
the sales price and set forth separately as such in the total amount
invoiced;
(3) freight, insurance and other transportation charges to the extent
added to the sales prices and set forth separately as such in the total
amount invoiced;
(4) amounts repaid or credited by reason of rejections, defects or
returns, or because of retroactive price reductions, or due to
governmental laws or regulations requiring rebates;
(5) import duties;
and means further the amount of fair market value of all other
consideration received by ▇▇▇▇▇, or its sublicensees or Affiliates in
respect of the Product, whether such consideration is in cash, payments in
kind, exchange or other forms; but does not mean sales of the Product
between or among ▇▇▇▇▇ and its sublicensees and/or Affiliates;
(6) except in the course of research, including pre-clinical experiments
and clinical studies, and in potential programs of humanitarian or
compassionate supply of Product, ▇▇▇▇▇ does not intend to supply unrelated
third parties with Product other than by sales of such Products. However,
should ▇▇▇▇▇'▇ intentions in that regard change, ▇▇▇▇▇ will enter
discussions with CAT concerning appropriate compensation to CAT for any
sales thereby lost.
1.27 [***].
1.28 "Patents" mean PCT applications WO 90/5144 (Winter 2) except as pertaining
to single variable domains as described in claims No. 32 - 40, as published on
May 17, 1990, and WO 92/1047 (▇▇▇▇▇▇▇▇▇▇), the patents when granted, including
any patents which derive from the Patents and any divisions, renewals,
continuations, continuations-in-part, extensions or reissues.
1.29 "BLA" means a Biologic License Application, or other application approving
the marketing of Product, which is submitted to the FDA.
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1.30 "Prior Agreement" has the meaning set forth above in the Recitals.
1.31 "Product(s)" means any pharmaceutical composition containing one or more
Antibodies.
1.32 "Proprietary Information" means any information, data, manufacturing
procedures, Regulatory Data, Know-How, samples and materials, which is/are not
publicly known or publicly available and which is/are disclosed by CAT,
Collaborator, ▇▇▇▇▇, or ▇▇▇▇▇'▇ Affiliates or sublicensees, to one another
pursuant to this Agreement, as well as all data and results obtained in the
course of the Research Program.
1.33 "Regulatory Data" means the medical, toxicological, pharmacological,
clinical and other data relating to Product which is necessary to, required for,
or included in any governmental regulatory filing to obtain or maintain
regulatory approval to market the Product, including postapproval reports,
filing and submissions.
1.34 "Research Program" shall have the meaning set forth in Article 2 with
respect to the research and development done with respect to each Target.
1.35 "Research Program Start Date" shall have the meaning set forth in Article
2 with respect to the start date of the Research Program for each Target.
1.36 "Target(s)" shall mean the Antigen(s) for which CAT and ▇▇▇▇▇ have agreed
to conduct a collaborative Research Program pursuant to Article 2 of this
Agreement.
1.37 "Target-3" shall mean IL-18.
1.38 "Target-X" where "X" is an integer selected from "4, 5, and 6"
corresponding to each subsequent Antigen designated pursuant to Article 18 of
the Agreement.
1.39 "Term" means the term of this Agreement under Article 16.
ARTICLE 2
RESEARCH PROGRAM
2.00 CAT and ▇▇▇▇▇ will conduct collaborative research and development with
respect to Target-3 and each Target designated pursuant to Article 18, with the
research and development for Target 3 being set forth in Schedule I to this
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Agreement, as amended from time to time to reflect mutually agreed changes or
the inclusion of newly designated Targets; the research and development program
directed to each such Target being referred to as a "Research Program". The
start date to begin the Research Program shall be mutually agreed upon by the
parties ("Research Program Start Date").
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1.40 Each party shall find its own costs of the Research Program subject to the
provisions of Article 3 below.
1.41 Both parties will report to each other on the progress of each Research
Program regularly, at least once per month and in writing every three (3) months
and at the conclusion of each Research Program:
1.42 CAT will disclose to ▇▇▇▇▇ all information concerning Antibodies and
information relating to selection, derivation and assays relating to Antibodies
developed under the Research Program. CAT shall, upon request, provide ▇▇▇▇▇ or
its Affiliates, Collaborators, sublicensees, or consultants with samples of any
materials produced under the Research Program, provided that prior to the
transfer of such samples, ▇▇▇▇▇'▇ collaborators, sublicensees, or consultants
shall execute ▇▇▇▇▇'▇ standard material transfer agreement.
1.43 ▇▇▇▇▇ may for any particular Target, designate, subject to the prior
approval of CAT which shall no unreasonably be withheld, a third party to
participate in the Research Program for that specific Target along with ▇▇▇▇▇
and CAT, provided that such party agrees to be bound by the terms of this
Agreement with respect to the specific Target, including the confidentiality
provisions hereof, and that, subject to Section 20.01, ▇▇▇▇▇ remains responsible
for the funding of the Research Program in accordance with the provisions of
this Agreement, such party being known as a "Collaborator".
ARTICLE 3
FUNDING
3.00 No amount shall be due from ▇▇▇▇▇ to CAT to fund the Research Program for
Target-3 and for each subsequent Target. ▇▇▇▇▇ shall pay [***] upon the
exercise of the Option granted under Section 4.00 of this Agreement.
1.44 ▇▇▇▇▇ will, in addition to the payments to be made pursuant to Sections
3.00 and 3.02 of this Agreement, make the following payments to CAT with respect
to the Target of each Research Program:
(1) provided that ▇▇▇▇▇ exercises its Option prior to achievement of CAT
Technical Milestone 4 [***] within 30 days of achievement of Milestone 4
[***] after achievement of CAT Technical Milestone 3 whichever is earlier;
and
(2) [***] within thirty (30) days of initiating the first human clinical
studies for the first Product for such Targets or [***] of achievement of
CAT Milestone 4, whichever is earlier and
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(3) [***] within thirty (30) days of ▇▇▇▇▇'▇ receipt of formal BLA
approval for the first Product for such Targets in any given country other
than the United States of America, or within nine years of the IND filing
in the United States for that Product, whichever is earlier.
1.45 ▇▇▇▇▇ will, in addition to the payments to be made pursuant to the
foregoing, make the following payments to CAT with respect to the Target of each
Research Program:
(1) [***] within thirty (30) days of the start of the Phase III clinical
studies of the first Product for Target-3;
(2) [***] within thirty (30) days of ▇▇▇▇▇'▇ receipt of formal BLA
approval in the United States of America for the first Product for such
Target, said payment to be reimbursable as follows: ▇▇▇▇▇ shall be
entitled to deduct [***] due to CAT for [***] until ▇▇▇▇▇ has recovered
[***].
ARTICLE 4
GRANTS and RESERVED RIGHTS
4.00 CAT grants to ▇▇▇▇▇ and its Affiliates an option (the "Option") to a
world-wide exclusive license under the Patents and CAT Know-How in the Exclusive
Field to manufacture and have manufactured, use and have used, sell and have
sold the Antibodies, Product(s) and Drug(s), including the right to sublicense
Collaborator(s) and any third party which has agreed to cooperate with ▇▇▇▇▇,
its Affiliates or Collaborator(s), in any country or countries or regions, to
develop, obtain regulatory approval for, manufacture, or market, Antibodies,
Product(s) or Drug(s) for the benefit of ▇▇▇▇▇, its Affiliates or
Collaborator(s).
1.46 As to each specific Target, ▇▇▇▇▇ shall have the right to exercise its
Option after Milestone 3 or Milestone 4 within the period stated below.
Milestones 3 and 4 will be considered complete (the "Completion", "Complete(s)"
or "Completed") when (1) CAT submits those items containing the attributes
listed under the heading "Content" ("CAT Deliverables") by the Timeframe stated
on Schedule II and (2) such CAT Deliverables are subsequently confirmed by ▇▇▇▇▇
to conform to those attributes listed on Schedule II ("Confirm(s)"). ▇▇▇▇▇
shall have a period of [***] from receipt of CAT Deliverables to Confirm such
CAT Deliverables.
As to each specific Target, ▇▇▇▇▇ shall have the right to exercise its Option
after the Completion of either Milestone 3 or Milestone 4 as follows:
1. ▇▇▇▇▇'▇ election to exercise its Option shall be considered, for
purposes of Section 5.00, to have been made following Milestone 3 if it is
made before the later of: (1) [***] after the receipt of [***] which are
later Confirmed to be Complete or (2) prior to receiving [***].
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2. ▇▇▇▇▇ shall have a period of [***] after the Completion of Milestone
4 to exercise its Option under the terms of Milestone 4.
As to each specific Target, ▇▇▇▇▇ will inform CAT within the [***] time period
as to whether Milestones 3 and 4 have been Completed. If CAT Completes
Milestone 4 for a specific Target and ▇▇▇▇▇ does not exercise the Option for
such Target within [***] of Completion of Milestone 4, than ▇▇▇▇▇ shall refrain
from subsequent development in the Field for such Target for a period of [***].
As to each specific Target, if ▇▇▇▇▇ exercises its Option to such Target, then
▇▇▇▇▇ shall not develop Antibodies to such Target with any third parties. In
the event that CAT does not Complete Milestone 3 or Milestone 4 for a specific
Target, then ▇▇▇▇▇ may, at ▇▇▇▇▇'▇ sole discretion, pursue research and
development in the Field independent of CAT.
1.47 In the event that ▇▇▇▇▇ does not exercise its Option to an exclusive
license for Target-3, or any subsequent Target, under the provisions of Section
4.01 of this Agreement, [***]. Moreover ▇▇▇▇▇ shall use reasonable efforts
[***], to assist CAT in any discussions aimed at [***].
1.48 CAT shall not license or grant any rights under the Patents or CAT Know-
How within the Exclusive Field to any third party during the term of this
Agreement.
1.49 ▇▇▇▇▇ grants an [***] sublicense in the Exclusive Field to CAT under the
[***] for the duration of each Research Program, to the extent necessary and for
the sole benefit of ▇▇▇▇▇, to permit CAT to conduct its activities under each
such Research Program, on the terms set out in Schedule IV to this Agreement.
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1.50 If ▇▇▇▇▇ exercises its Option, then CAT grants to ▇▇▇▇▇ and its Affiliates
title to all Inventions, Improvement Patent(s), and to all Antibodies and other
chemical and biological materials required to produce such Antibodies, which are
conceived, developed, discovered, generated or first reduced to practice, as the
case may be, during the Term of this Agreement, or within one (1) year
thereafter, whether by CAT or its Affiliates alone, or by ▇▇▇▇▇ or its
Affiliates alone, or jointly, and which are derived from the Research Program.
Inventions and Improvement Patents shall be assigned to ▇▇▇▇▇ and BASF jointly;
provided that where any such Inventions or Improvement Patents are made by CAT
or its Affiliates and by Collaborator or its Affiliates, with or without ▇▇▇▇▇
or its Affiliates, such Inventions or Improvement Patents shall be assigned by
CAT as shall be agreed between ▇▇▇▇▇ and Collaborator.
1.51 ▇▇▇▇▇ grants to CAT for the duration of each Research Program, the right
to use ▇▇▇▇▇ Know-How for the sole benefit of ▇▇▇▇▇ and for the sole purpose of
conducting the defined activities under such Research Program; provided,
however, that subject to ▇▇▇▇▇'▇ prior written approval, CAT may use ▇▇▇▇▇'▇
Regulatory Data in furtherance of CAT's development of products outside the
Exclusive Field.
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1.52 CAT agrees that for each Collaborator designated by ▇▇▇▇▇, CAT shall, if
so requested by such Collaborator, use its best efforts to secure the grant of a
license from MRC to Collaborator under the MRC-Patents on terms equivalent to
those granted by MRC to ▇▇▇▇▇.
1.53 ▇▇▇▇▇ Know-How shall remain the exclusive property of ▇▇▇▇▇ and
Collaborator Know-How shall remain the exclusive property of Collaborator,
except as ▇▇▇▇▇ and Collaborator may agree between them, and no right or
license, express or implied, is granted to CAT under ▇▇▇▇▇ Know-How by ▇▇▇▇▇ or
under Collaborator Know-How by Collaborator except as is expressly set forth
herein.
ARTICLE 5
ROYALTIES
5.00 If ▇▇▇▇▇ exercises its Option, pursuant to the provisions of Section 4.01
of this Agreement, after the successful Completion of Milestone 3, then ▇▇▇▇▇
shall pay to CAT royalty payments based upon the combined Net Sales of
Product(s) by ▇▇▇▇▇ and its Affiliates and sublicensees as follows:
(1) [***] of the amount of combined Net Sales of up to [***] in a given
year;
(2) [***] of the amount of the combined Net Sales [***] in a given year;
(3) [***] of the amount of combined Net Sales of over [***] in a given
year;
(4) Each of the above stated royalty percentages shall be increased by
[***], if ▇▇▇▇▇ exercises the Option after [***].
5.01 Sales of Product by Affiliates and sublicensees shall be deemed for the
purpose of this Agreement to be sales by ▇▇▇▇▇ and royalty payments shall be
made accordingly by ▇▇▇▇▇.
1.54 Royalties paid to third parties, other than to [***], to license rights
needed by ▇▇▇▇▇, its Affiliates or permitted sublicensees, to practice or to
have practiced the technology claimed in the Patents will be borne [***],
provided, however, that the royalty payable to CAT pursuant to Section 5.00
shall not be reduced below [***] of Net Sales or [***] of Net Sales if an
increased royalty payment is due under Section 5.00d in any year for which a
royalty is owed to CAT. The [***] royalty to be paid to [***] shall be paid
directly by ▇▇▇▇▇ to [***] and shall be directly offset against royalties due to
CAT pursuant to Section 5.00.
ARTICLE 6
PAYMENTS
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6.00 ▇▇▇▇▇ shall make payments to CAT with respect to the sale of Product by
▇▇▇▇▇, its sublicensees and its Affiliates, on a country-by-country basis,
commencing six months after the First Commercial Sale and to continue every six
months thereafter. Such payments shall be due ninety (90) days after the close
of each six months period.
1.55 Each payment or credit shall be accompanied by a report setting forth the
calculations of the amounts to be paid or credited on a country-by-country
basis.
1.56 If, in any country, any third party tries to obtain a compulsory license
or rights pursuant to governmental authority to market a Product, CAT agrees to
cooperate with ▇▇▇▇▇ at ▇▇▇▇▇'▇ expense to the extent legally permissible, and
▇▇▇▇▇ shall use reasonable and legal efforts to oppose the grant of such license
or rights and to obtain the highest royalty or payment rate possible.
1.57 All payments shall be in United States dollars, except those mentioned in
Article 3.
1.58 Payments due on Net Sales made in currency other than United States
dollars shall first be calculated in the foreign currency and then converted to
United States dollars on the basis of the monthly average exchange rate for the
preceding six (6) months in effect for the purchase of United States dollars
with such foreign currency as set forth in the Wall Street Journal (or
comparable publication if not quoted in the Wall Street Journal) with respect to
the currency of the country of origin of such payment on the last business day
of the payment computation period for which the payment is being made.
1.59 ▇▇▇▇▇ shall maintain true and complete books of account for a period of
six (6) years containing an accurate record of all data necessary for the proper
computation of payments due from it or charges made by it under this Agreement.
1.60 Upon request by CAT, ▇▇▇▇▇ agrees to make such books of account available,
upon reasonable notice and at reasonable times, for inspection by an independent
Certified Public Accounting firm which is acceptable to both parties. Such
inspection may take place at any time within two years after the date of payment
or charges to which they relate (but not more than once in each calendar year)
for the sole purpose of verifying the amount of such payments or charges and the
accuracy of such books of account.
1.61 Information furnished as a result of any such examination shall be limited
to a written statement by such certified public accountants to the effect that
they have reviewed the books of account of the party being audited and that:
(1) the amounts of the payments due or charges made under this Agreement
are in conformity with such books of account and the applicable provisions
of this Agreement; or
(2) adjustments are required and setting forth those adjustments.
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1.62 The fees and expenses of the audit shall be borne by CAT, unless a net
discrepancy of more than [***] in ▇▇▇▇▇=s favor is discovered. If any such
audit shows any underpayment or overpayment, a correcting payment or credit,
respectively, shall be made within thirty (30) days after receipt of the written
statement of the audit.
1.63 Any income or other tax that ▇▇▇▇▇, its Affiliates or sublicensees are
required by law to withhold and pay on behalf of CAT with respect to Royalties
paid to CAT under this Agreements shall be deducted from said Royalties prior to
remittance to CAT; provided, however, that in regard to any such tax so
deducted, ▇▇▇▇▇, its affiliates or sublicensees shall give or cause to be given
to CAT such assistance as may reasonably be necessary to enable CAT to claim
exemption therefrom or credit therefor, and in each case shall furnish CAT
proper evidence of such taxes paid on its behalf.
1.64 For royalty payments to a foreign company value added tax has to be
applied in the Federal Republic of Germany and has to be withheld by ▇▇▇▇▇.
According to a special statutory provision this withholding can be avoided, if
CAT's invoices of ▇▇▇▇▇'▇ reports do not show value added tax. To take
advantage of such provisions CAT will invoice net payments without VAT and
▇▇▇▇▇'▇ reports of statements will not include VAT.
1.65 In the event that during the term of this Agreement Sterling should, in
connection with the European Monetary Union, be replaced as the sole lawful
currency of the United Kingdom by a new lawful European currency (e.g. EURO) all
rights and obligations denominated in Pound Sterling shall be converted into the
new lawful currency according to the laws and regulations then applicable in The
United Kingdom.
ARTICLE 7
LIABILITY
7.00 ▇▇▇▇▇ shall be responsible for handling all product performance claims
related to the use of any Product and/or Drug which claim CAT has promptly
forwarded to ▇▇▇▇▇. ▇▇▇▇▇, its Affiliates and sublicensees hereby agree to
indemnify, defend and hold CAT harmless from all damages, losses, claims of
damages or losses, any and all related costs and expenses, including but not
limited to reasonable attorney's fees and court costs, incurred by CAT in
connection with any such claim (except in any circumstance where such liability
or damage is found to be the direct result of gross negligence or any fraudulent
conduct by CAT) provided that CAT shall give ▇▇▇▇▇ prompt written notice of any
such claim and full and complete authority, information and assistance, at
▇▇▇▇▇'▇ expense, for the defense thereof, including any settlements or appeals
related thereto, and provided further, such claim is not based upon the willful
or negligent acts or omissions of CAT.
1.66 ▇▇▇▇▇ agrees to pay directly for such damages, losses, claims of damages
or losses, any and all related expenses pursuant to Section 7.00. In no event
shall ▇▇▇▇▇ reduce its payments due CAT,
pursuant to Articles 3 and 5 in this Agreement, as a result of ▇▇▇▇▇ incurring
costs or expenses due to the operation of this Article 7.
ARTICLE 8
DAMAGES
8.00 Notwithstanding anything to the contrary set forth herein, except with
respect to a breach of any obligation under Article 9 below, in no event shall
either party have any liability for or responsibility to the other party for any
incidental or consequential damages based upon this Agreement or either party's
performance hereunder.
ARTICLE 9
CONFIDENTIALITY
9.00 The receiving party will retain all of the Proprietary Information in
confidence during the term of this Agreement and for a period of five (5) years
after termination of this Agreement and will not, without the prior written
permission of the other party or pursuant to Article 10 hereof, disclose it to
third parties, or use it for any purpose other than in accordance with the terms
of this Agreement, except:
(1) as provided for in Section 9.02 hereof; or with respect to:
(2) such of the Proprietary Information which is or becomes a part of the
public domain through no act or omission by the receiving party, or the
officers, employees, professional advisors or other representatives of the
receiving party or Affiliate thereof; or
(3) such of the Proprietary Information which was in the receiving party's
possession, as shown by written records, prior to the disclosure thereof
to the receiving party; or
(4) such of the Proprietary Information which is also received from a
third party having a right to disclose said Proprietary Information and
received free of any obligations not to disclose or use said Proprietary
Information.
9.01 For the purposes of the provisions of this Article 9, Proprietary
Information supplied by one party to the other party pursuant to this Agreement
shall not be deemed to be in the public domain or in the possession of receiving
party merely because it is embraced by general disclosures in the public domain
or in the prior possession of receiving party. In addition, any combination of
features shall not be deemed to be within the foregoing exceptions merely
because individual features are in the public domain or in the possession of
receiving party, but only if the combination is in the public domain or in the
possession of receiving party.
12
1.67 The receiving party shall have the right to communicate the Proprietary
Information or any part thereof to such employees, Collaborators, Affiliates or
consultants of receiving party who are required by their duties to have
knowledge thereof, on the conditions that each such employee or consultant shall
be informed that such information is Proprietary Information subject to this
Agreement, and shall be under an obligation of confidentiality with respect to
Proprietary Information received from the receiving party.
1.68 Each party shall have the right to disclose to others Proprietary
Information, to the extent such disclosure is reasonably necessary, in filing or
prosecuting patent applications, prosecuting or defending litigation, complying
with governmental regulations, conducting preclinical or clinical trials, or
seeking approval from or complying with the FDA, provided that if a party is
required to make any non-confidential disclosure of the other party's
Proprietary Information, the disclosing party will give reasonable advance
notice to the other party of such disclosure requirement, and will use
reasonable efforts to secure confidential treatment of such Proprietary
Information required to be disclosed.
Notwithstanding the above, all publicity, press releases and other
announcements relating to this Agreement or the transactions contemplated hereby
shall be reviewed in advanced by, and subject to the approval of, both parties;
provided, however, that either party may disclose the terms of this Agreement
insofar as required to comply with applicable securities laws, provided that in
the case of such securities disclosures the disclosing party will make
reasonable efforts to notify the other party in advance of such disclosure and
cooperates to minimize the scope and content of such disclosure.
1.69 CAT specifically agrees to maintain the confidentiality of Antibodies and
to refrain from providing any samples thereof to any third party. If ▇▇▇▇▇
exercises its option, then CAT and ▇▇▇▇▇ shall mutually agree as to the type of
information CAT shall be entitled to receive and disclose about any Antibodies.
ARTICLE 10
PUBLICATIONS
10.00 The parties agree that any proposed publications (including, but not
limited to abstracts, posters and the like) or public disclosure on the research
conducted under this Agreement shall be submitted to the other party at least
thirty (30) days prior to submission to a journal or other third party. A
proposed submission or disclosure shall be reviewed promptly; however, where
necessary, submission of disclosure may be delayed for an additional ninety (90)
days following the initial thirty day period for the purposes for preparing
related patent applications and for deleting particularly sensitive Proprietary
Information from said proposed disclosure if in the reasonable judgment of the
other party such patent applications are considered necessary and disclosure
would jeopardize potential protection.
13
ARTICLE 11
GOVERNING LAW
11.00 This Agreement shall be governed by and construed in accordance with the
law of England.
ARTICLE 12
INFRINGEMENT
12.00 If a third party in any country where the Product is being imported,
manufactured, used, or sold, notifies any of the parties, their Affiliates or
licensees that such activity infringes or is alleged to infringe any issued
patent either assigned to or licensed to such third party, then:
(1) the party so notified shall promptly notify the other parties in
writing; and
(2) within thirty (30) days of receipt of notice of the alleged
infringement, CAT will notify ▇▇▇▇▇ that it will either:
(1) indemnify ▇▇▇▇▇ and its Affiliates against any and all awards,
judgments and settlements which require ▇▇▇▇▇ or its Affiliates to pay
money to such third party and that it will defend the action at its
sole expense, or
(2) ▇▇▇▇▇ ▇▇▇▇▇ the right to defend, in its sole discretion, the
action and allow ▇▇▇▇▇ to take as a credit, on an ongoing basis during
the action, one half the cost of its external legal expenses and any
damages which may be awarded, against the royalties due to CAT from
Net Sales in the countries in which the claim of infringement is made,
up to a maximum credit of [***]. Such credit may not be taken by ▇▇▇▇▇
where the action involves a claim or right of a third party based upon
activities such as packaging of the Product or improvements to the
Product which are beyond the scope of the technology described in the
Patents.
12.01 In the event ▇▇▇▇▇ or its Collaborators must pay royalties or license
fees to third parties under one or more claims of one or more patents to enable
▇▇▇▇▇ or its Collaborators to utilize or have utilized the inventions of the
Patents, [***] shall be credited to ▇▇▇▇▇'▇ royalty obligations to CAT for sales
in that country where the patents exist. However, ▇▇▇▇▇'▇ royalty obligation to
CAT on Net Sales in any given country shall not be reduced, by operation of the
offset of this Section 12.01, below the minimum royalty rate, determined under
the provisions of Section 5.02, multiplied by Net Sales in such country. This
offset shall not include royalties or license fees which are beyond the scope of
the technology described in the Patents, for example fees paid to third parties
for delivery systems.
14
1.70 (a) In the event that ▇▇▇▇▇ shall learn of the infringement of any of the
Patents within the Exclusive Field, ▇▇▇▇▇ shall promptly notify CAT thereof in
writing and shall provide CAT with any evidence possessed by ▇▇▇▇▇ of such
infringement.
(b) During the Term of this Agreement, ▇▇▇▇▇ shall have the sole right, but
no obligation to bring any suit or action for infringement of the Patents
within the Exclusive Field. If ▇▇▇▇▇ finds it necessary or desirable to
join CAT in such suit or action, CAT shall execute all papers and perform
such other acts as may be reasonably required to do so and ▇▇▇▇▇ shall pay
CAT its reasonable expenses (including attorney's fees) and any award of
damages against CAT in any suit or action. CAT may, at its option, join as
a party to such suit and at its expense, be represented by counsel of its
choice. Unless ▇▇▇▇▇ and CAT otherwise agree, any amount recovered in any
such action, whether by judgment or settlement, after payment to CAT of its
reasonable expenses (including attorney's fees) shall be paid to or
retained by ▇▇▇▇▇. However, to the extent that damages are assessed and
actually awarded and paid to ▇▇▇▇▇ for lost sales, ▇▇▇▇▇ shall pay CAT a
royalty on such adjudicated lost sales at the royalty rate which would have
otherwise applied to those sales had they been made by ▇▇▇▇▇.
(c) In the event ▇▇▇▇▇ fails to take action within 90 days of learning of
such infringement, CAT shall have the sole right, but no obligation, to
bring, defend and maintain any appropriate suit or action involving
infringement of such a patent by manufacture, use or sale of the Product.
If CAT finds it necessary to join ▇▇▇▇▇ in such suit or action, ▇▇▇▇▇ shall
execute all papers and perform such other acts as may be reasonably
required. ▇▇▇▇▇ may, at its option, join as a party in such suit and, at
its expense, be represented by counsel of its choice. Unless ▇▇▇▇▇ and CAT
otherwise agree, any amount recovered in any such action or suit, whether
by judgement or settlement, after payment to ▇▇▇▇▇ of its reasonable
expenses (including attorney's fees), shall be paid to or retained by CAT.
(d) Each party agrees to cooperate with the other in any legal action to
enforce the Patents, including litigation proceedings.
1.71 Each party shall cooperate with the other party, to the extent reasonably
requested, in any legal action brought by or against the other party or both of
them or against their Affiliates or sublicensees in connection with the making,
using or selling of Product(s).
1.72 Each party agrees that it will use its best efforts whenever a protective
order is to be entered with a court of competent jurisdiction, to have the order
permit at least one patent counsel from each party (which, in the case of ▇▇▇▇▇,
shall be an attorney employed by ▇▇▇▇▇ or its Affiliates) access to information
provided under the protective order without restriction.
1.73 Neither party shall settle any claim or suit in any manner that may
adversely affect any patent of the other party or that would require any payment
or grant of a license or other rights by such party without the prior written
approval of the other party.
15
ARTICLE 13
DISPUTE RESOLUTION
13.00 The parties shall use all commercially reasonable efforts to solve any
disputes which may arise under this Agreement (including without limitation,
mediation and arbitration) before having recourse to litigation.
ARTICLE 14
WARRANTIES
14.00 CAT warrants:
(1) that it has the right to grant the license specified in this
Agreement;
(2) that to the best of its actual knowledge as of the Effective Date, all
relevant patents and patent applications in relation to the Patents are
set out in Schedule V to this Agreement;
----------
(3) that to the best of its actual knowledge as of the Effective Date, CAT
is not aware of any third party challenge to the validity of the Patents
except for those set forth in Schedule VI;
-----------
(4) that CAT will use all commercially reasonable efforts to perform the
Research Programs.
14.1 ▇▇▇▇▇ warrants:
(5) that it has all necessary authority to enter into this Agreement and
to supply to CAT the materials and expertise referred to in Schedule I;
(6) that it will use all commercially reasonable efforts to meet the ▇▇▇▇▇
Milestones set out in Schedule I to this Agreement, to develop marketable
----------
Products of good merchantable quality and to bring those Products to
market within the time usually taken to bring products of a similar nature
to market and to satisfy market demand for those Products.
(7) that ▇▇▇▇▇ has an exclusive and irrevocable option to acquire an
exclusive, worldwide, milestone-bearing and royalty-bearing license, with
the right to sublicense, to Hayashibara Biochemical Laboratories' patent
applications directed to monoclonal antibodies corresponding to patent
applications EP692,536 and EP712,931 including any continuation
applications, continuation-in-part applications and divisional
applications and any reissue, reexamination or extensions of such patents
issuing therefrom and any foreign
16
patent applications relating thereto to make, use, import, lease and sell
products for all human indications.
1.74 CAT gives no warranty, express or implied, that the technology covered by
the Patents will work when applied to any particular purpose.
ARTICLE 15
NOTICES
15.00 All notices or other communications required or permitted to be given by
either party under this Agreement shall be in writing and shall, unless
otherwise specifically set forth herein, be sufficiently given by either party
when deposited in the mail, registered or certified, postage prepaid, or by
telefacsimile, and addressed as hereinafter set forth or to such other addressee
and/or address as or shall subsequently be designated by either party by notice
given in accordance with this Section.
To ▇▇▇▇▇: ▇▇▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ on Rhine
Attn: Legal Department
with copy to: BASF Bioresearch Corp.
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attn: President
To CAT: Cambridge Antibody Technology Ltd.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
Attn: Company Secretary
1.75 Either party may change the address or the recipient to which notice is to
be provided by written notice pursuant to Section 15.00.
ARTICLE 16
TERM AND TERMINATION
16.00 Unless and until earlier terminated as provided in paragraphs 16.01 and
16.02, this Agreement shall commence on the Initial Date and shall continue
until the last to expire of the Patents, which are necessary to make, use or
sell a Product(s) or th expiry of fifteen years from the date of First
Commercial Sale of a Product by ▇▇▇▇▇ or its Affiliates or sublicensees
(whichever is the later).
17
1.76 If either party breaches or defaults in the performance or observance of
any its material obligations under this Agreement, and such breach or default is
not cured within one hundred twenty (120) days after receipt by such party of a
written notice from the non-breaching party specifying the breach or default (or
such longer period as is reasonably necessary if the breach is of such a nature
that it cannot be reasonably cured within one hundred twenty (120) days, then
the non-breaching party shall have the right to terminate this Agreement upon an
additional sixty (60) days written notice to the breaching or defaulting party.
1.77 Either party may terminate this Agreement by written notice to the other
party in the event the other party shall have become insolvent or bankrupt, or
shall have made an assignment for the benefit of its creditors, or there shall
have been appointed a trustee or receiver of the other party or for all or a
substantial part of its property, or any case or proceeding shall have been
commenced or other action taken by or against the other party in bankruptcy or
seeking reorganization, liquidation (other than for the purpose of
reconstruction or amalgamation), dissolution, winding-up, arrangement,
composition or readjustment of its deeds or any other relief under any
bankruptcy, insolvency, reorganization or other similar act, and any such event
shall have continued for ninety (90) days undismissed and undischarged.
1.78 ▇▇▇▇▇ may terminate this Agreement with respect to Target-3 or any
subsequent Target if CAT has not achieved CAT Milestone 3 or CAT Milestone 4
within the time frames established at Schedule II. Termination on a Target
under this Section shall not terminate CAT's ongoing obligations with respect to
any ongoing Target nor shall it terminate ▇▇▇▇▇'▇ rights under Section 18.00(c).
1.79 In the event that ▇▇▇▇▇ is unable to license on commercially reasonable
terms any third party patent rights which would be infringed by the manufacture,
use or sale of the Antibodies, Product(s) or Drug, then ▇▇▇▇▇ shall have the
option, upon [***] notice to CAT, to terminate the Research Program with respect
to the Target so affected.
1.80 Termination of this Agreement is to be without prejudice to rights of
either party which have accrued and are due prior to termination.
ARTICLE 17
IMPROVEMENT PATENTS AND INTELLECTUAL PROPERTY
17.00 Each party shall promptly notify the other party upon receiving a
disclosure of an Invention which might lead to an Improvement Patent. ▇▇▇▇▇
will assume responsibility for filing Improvement Patents in all countries. All
expenses incurred by ▇▇▇▇▇ in applying for patent protection relating to
Inventions contemplated under this Agreement shall be borne by ▇▇▇▇▇.
18
1.81 ▇▇▇▇▇ shall decide whether to file patent applications on Inventions
developed during the term of this Agreement.
1.82 CAT shall assist ▇▇▇▇▇, at ▇▇▇▇▇'▇ expense, in the filing of Improvement
Patents.
1.83 ▇▇▇▇▇ will pursue and assume full responsibility, and bear the costs for
obtaining authorizations, including, but not limited to an NDA and BLA or other
similar governmental approval, to market the Product.
1.84 In the event that ▇▇▇▇▇ decides to abandon or no longer maintain any
Improvement Patent, or ▇▇▇▇▇ does not exercise its Option under 4.01, then
subject to any pre-existing obligations which ▇▇▇▇▇ may have to any third party
with respect to such Improvement Patent, ▇▇▇▇▇ will offer the rights to such
Improvement Patent to CAT at nominal cost subject to the provisions of Section
4.02. CAT shall bear all further costs in connection with prosecuting and
maintaining such Improvement Patent.
1.85 ▇▇▇▇▇ shall be responsible, with the full and timely cooperation of CAT at
▇▇▇▇▇'▇ expense (which shall include the execution of any documents which may be
required from time to time), for preparing, filing and prosecuting patent
applications in such countries as ▇▇▇▇▇, in its sole discretion, may elect and
shall be responsible for the payment of all fees, including maintenance fees.
ARTICLE 18
ADDITIONAL PROGRAMS & AREAS OF EXCLUSIVITY
18.00 CAT agrees to conduct additional Research Programs directed to Targets in
addition to Target-3 on behalf of ▇▇▇▇▇ and at ▇▇▇▇▇'▇ election, on terms
specified in this Agreement, adding the new Target(s) to the definition of the
Antigen in Section 1.03 and adding the new Target(s) to the definition of Field
in Section 1.14 throughout this Agreement, and defining a Research Program for
each such Target pursuant to Section 2.00, with the following limitations:
(1) As of the Effective Date, CAT agrees to reserve two additional targets
to be named by ▇▇▇▇▇ within ten (10) months of the Effective Date, and
their receptors as a pool of exclusive ▇▇▇▇▇ targets. CAT agrees to
refrain from collaborating with, or granting any rights to, any third
party with respect to any exclusive target unless or until ▇▇▇▇▇'▇ period
of exclusivity terminates pursuant to Section 18.00(c) or (d). CAT grants
the right to ▇▇▇▇▇ ▇▇ to replace these targets within [***] of the
Effective Date by a letter to CAT as provided under Article 15. CAT has
the right to reject these replacement targets as specified under Article
18.00 (b) but will allow ▇▇▇▇▇ to designate a new target until an
agreement has been reached for both exclusive targets.
(2) Each time ▇▇▇▇▇ initiates an additional Research Program with CAT
under this Article, ▇▇▇▇▇ may specify one additional target pair
comprising a designated cytokine and its receptor to be subject to a ▇▇▇▇▇
right of first refusal, to a maximum combined total of six (6)
19
exclusive ▇▇▇▇▇ targets and right-of-first-refusal targets. However, CAT
shall have the right to reject a proposed new right of first refusal
target pair if within two weeks of the date of said proposal. [***]. CAT
agrees to refrain from collaborating with, or granting any rights to, any
third party with respect to any target which is subject to a ▇▇▇▇▇ right
of first refusal unless CAT has first provided ▇▇▇▇▇ with [***]. ▇▇▇▇▇
shall have the right to initiate such additional ▇▇▇▇▇ Research Program
with CAT with respect to such target by providing CAT with written
notification within [***] from its receipt of CAT's written notice of
third party interest.
(3) ▇▇▇▇▇'▇ right to initiate each subsequent Research Program hereunder
shall terminate [***]. In the event that ▇▇▇▇▇ terminates this agreement
with respect to a Target under the provisions of Section 16.03, then ▇▇▇▇▇
shall have [***] from such termination date to initiate a subsequent
Research Program.
(4) Royalty payments, milestone payments and other terms for Target-3,
Target-4, Target-5 and Target-6 will be as specified herein. Royalty
payments, Milestone payments and other terms for Target-1 and Target-2
will be as specified in the Prior Agreement. The set of milestone payments
with respect to Target-4 through Target-6 shall be increased from the
milestone payments specified herein for Target-3 by [***] for each
subsequent twelve month period between the Effective Date and the
initiation of the Research Program directed to such subsequent Target.
ARTICLE 19
FORCE MAJEURE
19.00 Neither party to this Agreement shall be liable for failure or delay in
the performance of any of its obligations hereunder, if such failure or delay is
due to causes beyond its reasonable control, including, without limitation, acts
of God, earthquakes, fires, strikes, acts of war, or intervention of any
governmental authority, but any such delay or failure shall be remedied by such
party as soon as reasonably possible after the removal of the cause of such
failure or delay.
ARTICLE 20
WAIVER AND ASSIGNMENT
20.00 The right of either party at any time to require strict performance by
other party hereto of all the terms and conditions hereof shall not in any way
be affected or impaired by prior waiver, forbearance or course of dealing.
1.86 This Agreement shall not be assigned by either party without the prior
written consent of the other party, such consent not be unreasonably withheld,
except that either party may assign this Agreement, in whole or in part, to an
Affiliate of such party or to the successor (including the
20
surviving company in any consolidation, reorganization or merger) or assignee of
all or substantially all of its business to which this Agreement pertains, and
except that ▇▇▇▇▇ may assign its rights and obligations hereunder with respect
to any specific Target for which it has designated a Collaborator, to such
Collaborator.
1.87 This Agreement shall be binding upon any permitted assignee of either
party.
ARTICLE 21
MISCELLANEOUS
21.00 If any provision of this Agreement is held by a court of competent
jurisdiction to be invalid or unenforceable, it shall be modified, if possible,
to the minimum extent necessary to make it valid and enforceable or, if such
modification is not possible, it shall be stricken and the remaining provisions
shall remain in full force and effect; provided, however, that if a provision is
stricken as to materially affect the economic benefits of Agreement, the party
adversely affected may terminate this Agreement upon sixty days prior written
notice to the other party.
1.88 The headings set forth at the beginning of the various Articles and
Sections of this Agreement are for reference and convenience and shall not
affect the meanings of the provisions of this Agreement.
1.89 Neither party shall have the right to disclose to third parties the terms
and conditions of this Agreement without the express written consent of the
other party, except as may be required by applicable law. If a party decides to
make an announcement it believes to be required by law with respect to this
Agreement, it will give the other party such notice as is reasonably practicable
and an opportunity to comment upon the announcement.
1.90 Neither party shall originate any publicity, news release or public
announcement, written or oral, whether to the public or the press, stockholders
or otherwise, referring to the terms of this Agreement, including its existence,
the subject matter to which it relates, the performance under it or any of its
existence, the subject matter to which it relates, the performance under it or
any of its specific terms and conditions without prior approval by the other
party, except as required by law. A copy of such announcement shall be provided
to the other party for comment before it is made public.
1.91 Nothing contained in this Agreement shall be construed as conferring any
right to use in advertising, or other promotional activities, any name, trade
name, trademark, or other designation of either party thereto.
1.92 The provisions of Articles 7 and 9 shall survive the termination for any
reason of this Agreement.
21
1.93 The obligation to make payments under Article 3 of this Agreement with
respect to any period prior to its termination shall survive the termination of
this Agreement.
1.94 Prior to the execution of this Agreement, the parties have had numerous
discussions, conversations and negotiations, and have generated correspondence,
writings and other memoranda with respect to the subject matter of this
Agreement; notwithstanding which, this Agreement (including its Exhibits) is
intended to define the full extent of the parties respective agreements,
arrangements and obligations with respect to the subject matter hereof, and each
party represents that it is not relying on any such other discussions,
conversations, negotiations, correspondence, writings and memoranda in executing
and delivering this Agreement or performing its respective obligations
hereunder.
1.95 This Agreement may be executed in multiple counterparts, each of which
shall be deemed an original and which together shall constitute one and the same
instrument.
22
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized officers as of the Effective Date.
▇▇▇▇▇ ▇▇ Cambridge Antibody
Technology Ltd.
BY: /s/ ▇▇▇▇. ▇▇▇▇▇▇▇ /s/ ▇▇. ▇▇▇▇▇▇▇▇▇ BY: /s/ ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
NAME: ___________________________________ NAME: ______________________________
TITLE: __________________________________ TITLE: Chief Executive Officer _____
23
Schedule I
Research Plan
[***]
Schedule II
-------------------------------------------------------------------------------
Milestone Content Timeframe*
-------------------------------------------------------------------------------
[***]
March 1993
SCHEDULE III
[***-- Seven pages redacted]
SCHEDULE IV
Sublicence to ▇▇▇▇▇▇▇▇▇ Patent
Between
▇▇▇▇▇ ▇▇, a German Corporation having a place of business at ▇▇▇▇▇▇▇▇▇▇▇ ▇▇,
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ of Germany (hereinafter "▇▇▇▇▇")
and
Cambridge Antibody Technology Limited, an English corporation having a place of
business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, Great Britain
(hereinafter "CAT")
RECITAL
By an agreement dated June 29, 1993, the Medical Research Council granted to
▇▇▇▇▇ a sub-licence to the ▇▇▇▇▇▇▇▇▇ Patent Rights as hereinafter defined with
the power further to sublicence the ▇▇▇▇▇▇▇▇▇ Patent Rights
IT IS AGREED
1. The ▇▇▇▇▇▇▇▇▇ Patent Rights are those rights set out in the Annex to this
sub-licence agreement.
2. ▇▇▇▇▇ grants to CAT a sublicence to the ▇▇▇▇▇▇▇▇▇ Patent Rights in the
Exclusive Field, as that expression is defined in a Development and Licence
Agreement (the "Head Agreement") dated ( ) between
the parties to permit CAT to conduct its activities under the Research
Program (as defined in the Head Agreement) in relation to human tumour
necrosis factor-(c) (TNF-a)
Ludwigshafen, August 25th, 1993 Melbourn,
▇▇▇▇▇ ▇▇ ppa. Cambridge Antibody Technology Ltd.
▇▇▇▇. ▇▇▇▇▇▇▇ Kahlstorff
2
Schedule V
Patents
Inventor: Winter et al (Winter2)
Number: EP 0 368 684 B1
Inventor: ▇▇▇▇▇▇▇▇▇▇ et al
Number: PCT/GB91/01134, EP 0 589 877B1
Inventor: ▇▇▇▇▇▇ et al
Number: US 4,683,202
Inventor: ▇▇▇▇, ▇▇▇▇▇ and/or ▇▇▇▇▇▇
Number: WO90/14443; WO90/14424; WO90/14430
Inventor: ▇▇▇▇▇▇
Number: WO88/06630
Inventor: ▇▇▇▇▇▇ and ▇▇▇▇▇▇▇▇
Number: WO90/03809
Inventor: Dower and Cwirla
Number: PCT/US91/02989
Inventor: Wigler
3
Number: WO91/10737
Inventor: ▇▇▇▇▇▇▇▇▇ and Rabbitts
Number: GB 2177 096A
Inventor: Bird et al
Number: US 4,704,692
Inventor: Houston et al
Number: US 5,091,513
Inventor: Boss et al
Number: US 4,816,397
Inventor: Cabilly et al
Number: US 4,816,567
Inventor: Pluckthun and Skerra
Number: EP 0 324162
Inventor: Lei et al
Number: WO 89/06283
Inventor: Winter et al
Number: PCT/GB92/00883; WO92/20781
4
Inventor: ▇▇▇▇▇▇▇▇▇▇ et al
Number: PCT/GB92/01755
Inventor: ▇▇▇▇▇▇▇▇▇ et al
Number: PCT/GB92/02240
Inventor: Embleton et al
Number: PCT/GB92/01483; WO93/03151
Inventor: Winter et al
Number: PCT/GB93/00605
Inventor: Kang et al
Number: PCT/US92/03091; WO92/18619
Inventor: Jespers et al
Number: PCT/GB94/01422
Inventor: ▇▇▇▇▇▇▇▇▇ et al
Number: PCT/GB94/02662
Inventor: ▇▇▇▇▇▇▇▇▇ et al
Number: US CIP 08/307,619
5
Inventor: ▇▇▇▇▇▇▇ et al
Number: PCT/US91/09133
Inventor: ▇▇▇▇
Number: PCT/US91/07149
Inventor: ▇▇▇▇▇▇▇▇ et al
Number: EP 0 247 091 B1; EP 0 371 998 B1
EP 0 550 400 A2
Inventor: Ballivet and ▇▇▇▇▇▇▇▇
Number: EP 0 229 046 B1
Inventor: Barbas et al
Number: PCT/US94/01234
Inventor: Krebber et al
Number: EP 0 614 989 A1
Inventor: ▇▇▇▇▇▇ and ▇▇▇▇▇
Number: EP 0 557 897 A1
Inventor: Breitling et al
Number: PCT/GB92/01524
6
Inventor: ▇▇▇▇▇▇▇ et al
Number: PCT/GB97/01835
7
Schedule VI
3/rd/ Party Opposition
EP 0 368 684B1 (Winter 2) - - Opposition filed by Morphosys GmbH.
EP 0 589 877B1 (▇▇▇▇▇▇▇▇▇▇ et al) Opposition filed by Morphosys GmbH,
BioInvent Therapeutic AB,
Pharmacia & Upjohn, Dyax Corp.
In the Winter 2 application in the US, the USPO has declared an interference
with application filed by ▇▇▇▇, ▇▇▇▇▇ and/or ▇▇▇▇▇▇. Winter is the senior
party.
8