DATED JULY 30, 2007 CAMBRIDGE ANTIBODY TECHNOLOGY LIMITED (1) and DYAX CORP. (2) AMENDED AND RESTATED LICENSE AGREEMENT
Exhibit
10.1
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DATED
JULY 30, 2007
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______________________________________________
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(1)
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and
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(2)
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______________________________________________
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AMENDED
AND RESTATED LICENSE AGREEMENT
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______________________________________________
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THIS
AGREEMENT is made as of July 30, 2007
BETWEEN:
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CAMBRIDGE
ANTIBODY TECHNOLOGY LIMITED (Registered in England No. 2451177)
whose registered office is at The ▇▇▇▇▇▇▇▇ Building, Granta Park,
Cambridge, Cambridgeshire, CB1 6GH, UK
("CAT").
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(2)
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DYAX
CORP. a corporation organised and existing under the laws of
the
State of Delaware having its principal place of business at ▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇
("Dyax").
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(a)
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The
Parties entered into the Original Agreements; an Amendment Agreement,
a
Second Amendment Agreement which agreements were consolidated in
an
Amended and Restated Agreement (as defined below) regarding the
use of
their respective rights in (b) and (c)
below.
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(b)
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CAT
is the owner or exclusive licensee (pursuant to an agreement dated
7
January 1997 between CAT and the Medical Research Council
("MRC")) of the CAT Antibody Phage Display Patents
(as
defined below).
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(c)
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Dyax
has the right to grant licenses to certain technology described
and
claimed in US Patent No. 5,223,409 entitled "Directed Evolution
of Novel
Binding Proteins", US Patent No. 5,403,484 entitled "Viruses Expressing
Chimeric Binding Proteins", US Patent No. 5,571,698 entitled "Directed
Evolution of Novel Binding Proteins", and other Patent Rights (as
defined
below).
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(d)
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By
this Agreement the Parties wish to make further changes to the
agreement
between them including to provide for the supply to CAT by Dyax
of the
Dyax Antibody Library (as defined below) and the grant of certain
rights
by Dyax to CAT in relation thereto.
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In
consideration of the mutual covenants and undertakings set out below,
THE PARTIES AGREE as follows:
1. Definitions
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1.1
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In
this Agreement, the terms defined in this Clause shall have the
meanings
specified below:
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"Abbott
Agreement" means the Agreement dated 20 January 1994 between CAT and
▇▇▇▇▇ ▇▇ (now known as ▇▇▇▇▇▇ Laboratories Inc) and relating to
D2E7.
"Acceptance
Fee" means the payment to CAT by Dyax or a Dyax Sublicensee, as
appropriate, under Clauses 8.1.1, 8.2.1, and 8.3.1 hereof.
"Additional
Diagnostic Licences" means the Dyax Product Licences detailed in Clause
3.7.
"Additional
Licence Allocation" means the [*****] Dyax
Product Licences in Clause 3.5.
Confidential
materials omitted and filed separately with the Securities and Exchange
Commission. Asteriks denote such omission.
1
"Affiliate"
means any company, partnership or other entity which directly or indirectly
Controls, is Controlled by or is under common Control with any other
entity.
"Affimed
License" means that certain Patent Cross-License Agreement dated August
4, 2003 by and between Affimed Therapeutics AG ("Affimed") and Dyax, a redacted
copy of which has been provided to CAT.
"Affimed
Patent Rights" has the meaning set forth in Schedule 9-A.
"Agreement" means
this agreement and any and all Schedules, appendices and other addenda to
it as
may be amended from time to time in accordance with the provisions of this
agreement.
"Amendment
Agreement" means the agreement made between CAT and Dyax, dated 3
January 2003, to amend the Original Agreements.
"Amended
and Restated Agreement" means the agreement made between CAT and Dyax,
dated 21 June 2006.
"Antibody" means
a molecule or a gene encoding such a molecule comprising or containing one
or
more immunoglobulin variable domains or parts of such domains or any existing
or
future fragments, variants, modifications or derivatives thereof.
"Antibody
Diagnostic License Agreement" means the License
Agreement between Dyax and CAT dated 31 December 1997 relating to antibody
diagnostic products.
"Antibody
Library" means any Antibody library constructed using processes which
are covered by a claim of an issued and unexpired patent included within
the CAT
Antibody Phage Display Patents which has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction unappealed within the time allowed for appeal,
and
which has not been admitted to be invalid or unenforceable through reissue
or
disclaimer or otherwise.
"Antibody
Services" means the provision of research and/or development services
for the identification, generation, derivation or development of one or more
Antibody Libraries or Antibodies derived therefrom.
"Biosite
License" means the license agreement effective March 28, 2002 between
Biosite Incorporated ("Biosite") and Dyax, a redacted copy of which has been
provided to CAT.
"Biosite
Patent Rights" has the meaning set forth in
Schedule 9-B.
"Bi-Specific
Antibody" means an Antibody directed to two Nominated Targets as
described in Clause 4.6.
"Business
Day" means a day (other than a Saturday or Sunday) on which the banks
are ordinarily open for business in the City of London and the Commonwealth
of
Massachusetts.
2
"CAT
Antibody Phage Display Patents" means: (a) the patents and patent
applications listed in Schedule 1 and any patents issuing from such
patent applications, together with any divisions, registrations, confirmations,
reissues, extensions, renewals, continuations, continuations-in-part,
revalidations, additions, substitutions, renewals or supplementary protection
certificates thereof throughout the world; and (b) any Patent Rights which
claim
or cover any invention or discovery which is developed by CAT or its Affiliates
at any time during the term of this Agreement directly related to Antibody
phage
display or Antibody Services; provided, however, that CAT Antibody
Phage Display Patents shall always exclude (i) CAT Diabodies Patent Rights,
(ii)
any Patent Rights owned or controlled by CAT which claim or cover Catalytic
Antibodies, (iii) any Patent Rights owned or controlled by CAT which claim
ribosome display technology, (iv) any Patent Rights which claim Single Domain
Antibodies, (v) any Patent Rights acquired by CAT after 3 January 2003 from
any
Third Party for consideration or as a result of CAT's acquisition of or merger
with such Third Party, and (vi) any use of the said Patent Rights in the
field
of Research Products.
"CAT
Diabodies Patent Rights" means (a) the Patent
Rights entitled "Diabodies – multivalent and multispecific binding proteins,
their manufacture and use", PCT/GB93/02492 and (b) the Patent Rights entitled
"Retargeting antibodies and diabodies", PCT/GB94/02019.
"CAT
Gatekeeping Procedure" means the procedure set out in Schedule 2
which CAT shall carry out in respect of a Nominated Target prior to the grant
of
any Dyax Product Licence.
"CAT
Know-How" means any Confidential Information of
CAT which constitutes unpatented know-how, technical and other information
related to the subject matter of the CAT Antibody Phage Display Patents as
identified in Schedule 3 and as amended from time to time in accordance
with Schedule 3;
"CAT
Licensable Antibody" means any Antibody (including a Bi–Specific
Antibody or a Poly-Specific Antibody) to a Target (a) where such Antibody
has
been identified, generated, developed, produced or derived by Dyax or a Dyax
Sublicensee or its sublicensees and (b) the identification, generation,
development, production or derivation of such Antibody uses any of the processes
claimed or covered by a claim of an issued and unexpired patent included
within
the CAT Antibody Phage Display Patents (which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other governmental
agency of competent jurisdiction unappealed within the time allowed for appeal,
and which has not been admitted to be invalid or unenforceable through reissue
or disclaimer or otherwise) or uses the CAT Know-How and (c) which is
potentially useful for the development of any Diagnostic Antibody Product
and/or
any Therapeutic Antibody Product.
"CAT
Product" means (a) any preparation for the treatment or prevention of
disease, infection, or other condition in humans for any indication which
contains, comprises, or the process of development or manufacture of which
utilises a Dyax Licensable Antibody or (b) any preparation in the form of
a
device, compound, kit or service with utility in the diagnosis, prognosis,
prediction, or disease management of a disorder for any indication which
contains, comprises or the process of development or manufacture of which
utilises a Dyax Licensable Antibody.
3
"CAT
Product Licences" means each licence granted to CAT pursuant to Clause
12.
"CAT
Site" means the CAT premises described in Clause 11.3.
"CAT
Status Report" means the report described in Clause 12.4.
"CAT
Sublicensee" means any Third Party to which CAT grants a sublicense in
accordance with the terms of this Agreement, under a CAT Product
Licence.
"Catalytic
Antibodies" means solely those Antibodies which
bind to and catalyze the chemical transformation of a substrate and in which
an
Antibody binding region is involved in said catalysis.
"Commencement
Date" means 3 January 2003.
"Commercial
Party" shall mean any party, other than an Affiliate of CAT, which has
been authorized by CAT to make, have made, use, sell or have sold Licensed
Products and (i) to which CAT (or any of its Affiliates), sells, transfers,
or
otherwise makes available any Licensed Intermediate or (ii) for which CAT
(or
any of its Affiliates) performs services or provides proprietary information,
with respect to any Licensed Intermediate.
"Competent
Authority" means any national or local agency, authority, department,
inspectorate, minister, ministry official, parliament or public or statutory
person (whether autonomous or not) of any government of any country having
jurisdiction over either any of the activities contemplated by this Agreement
or
the Parties including the European Commission, the Court of First Instance
and
the European Court of Justice.
"Controls"
means the ownership, directly or indirectly, of more than fifty percent (50%)
of
the outstanding equity securities of a corporation which are entitled to
vote in
the election of directors or a more than fifty percent (50%) interest in
the net
assets or profits of an entity which is not a corporation.
"Development
and Licence Agreement" means the agreement referred to in Clause 8.7 of
this Agreement.
"Development
Licence" means a licence as described in Clause 10.1.
"Development
Licence Option" means the option for CAT to enter into a Development
Licence with Dyax for any Dyax Therapeutic Antibody Product as described
in
Clause 10.1;
"Development
Licence Option Notice" means the notice described in Clause
10.2;
"Diagnostic
Antibody Product" means any preparation in the form of a device,
compound, kit or service with utility in the diagnosis, prognosis, prediction
or
disease management of a disorder for any indication which contains, comprises
or
the process of development or manufacture of which utilises a CAT Licensable
Antibody. The term "Diagnostic Antibody Product"
shall not include any Research Product.
"Diagnostic
Collaboration Licences" means the Dyax Product Licences detailed in
Clause 3.6.
4
"Disclosing
Party" means a Party which discloses Confidential Information to the
other Party.
"Domantis
License" means that certain Cross License Agreement dated April 6, 2006
by and between Domantis Limited ("Domantis") and Dyax, a redacted copy of
which
has been provided to CAT.
"Domantis
Patent Rights" has the meaning set forth in Schedule 9-C.
"Dyax
Antibody Library" means Dyax's proprietary phagemid-based Fab libraries
and phage-based Fab libraries of human antibody sequences as identified in
Schedule 6.
"Dyax
Antibody Library Improvements" means the improvements described in
Clause 11.7(f).
"Dyax
Know-How" means the Confidential Information of Dyax which constitutes
unpatented know how, technical and other information related to the subject
matter of the Dyax Patent Rights and Dyax Antibody Libraries, as identified
in
Schedule 6 as updated from time to time in accordance with Clause
11.5.
"Dyax
Licensable Antibody" means any Antibody (including a Bi–Specific or
Poly- Specific Antibody) to a Target which Antibody has been selected by
CAT
from the Dyax Antibody Library.
"Dyax
Materials" means the materials which comprise or
relate to the Dyax Antibody Library as described in Schedule 6 together with
any
materials which comprise or relate to any improved version of the Dyax Antibody
Library and made available to CAT by Dyax in accordance with Clause
11.4.
"Dyax
Partner" means (a) any person or entity with whom Dyax has entered into
a written agreement for the performance of Antibody Services or other services
related to the commercialization of any Product, or (b) any other Third Party
to
which Dyax is selling or licensing in good faith in accordance with its normal
business practice CAT Antibody Libraries or Antibodies derived therefrom;
provided, that in no event shall the term "Dyax Partner"
include any Third Party which is a bare licensee under the Dyax Patent
Rights.
"Dyax
Patent Rights" means all Valid Claims of the patents and patent
applications listed in Schedule 5, as well as any and all, reissues,
reexaminations, renewals and extensions thereof, and any and all continuations,
continuations-in-part and divisionals of the applications for such patents
in
the United States and all counterparts thereto in countries outside the United
States but shall not include (i) Valid Claims in US Patent No. 5,233,409
to the
extent they cover single chain antibodies, nor (ii) Valid Claims of any
continuation, continuation-in-part or divisional applications of the US Patents
or any counterparts of the US Patents in countries outside of the United
States,
that cover particular protein or peptide sequences, or nucleic acids thereof,
that bind to a specific biological or molecular target. Dyax Patent
Rights include the Dyax Base Phage Display Patent Rights (the patents and
patent
applications listed in Schedule 5A) and the Dyax Library-Related Patent Rights
(the patents and patent applications listed in Schedule 5B).
"Dyax
Product Licence" means each license granted to Dyax pursuant to Clause
5.1.
5
"Dyax
Therapeutic Antibody Product" means any Therapeutic Antibody Product
identified, generated or derived by Dyax for itself or its Affiliates but
not a
Therapeutic Antibody Product identified, generated or derived by Dyax for,
or on
behalf of, a Third Party.
"Dyax
Sublicensee" means any (a) Dyax Partner to which Dyax grants a
sublicense in accordance with the terms of this Agreement, and/or (b) any
sublicensee of Dyax under a Dyax Product Licence.
"Dyax
Target Option Notice" means the notice described in Clause
4.1.
"D2E7"
means any Antibody directed against the Target TNF alpha.
"End
User" shall mean a person or entity whose use of a product results in
its destruction, loss of activity and/or loss of value.
"Exploit"
means to make, have made, use, sell or import.
"Extension
Fee" means the fee described in Clause 4.2.
"FDA"
means the United States Food and Drug Administration, the equivalent Competent
Authority in any country of the Territory or any successor bodies
thereto.
"Field
of Use" means research and development of human or non-human
therapeutics and human or non-human in vitro diagnostic or research reagent
uses
only and not any in vivo diagnostics, purifications or separations, or other
industrial purposes.
"First
Commercial Sale" means the first commercial sale of (a) any Product, or
Other Product by Dyax or a Dyax Sublicensee (or its sublicensee) or (b) any
CAT
Product by CAT or a CAT Sublicensee (or its Sublicensee) in each case
in any country after grant of a Marketing Authorisation.
"Force
Majeure" means any event outside the reasonable control of either Party
affecting its ability to perform any of its obligations (other than payment)
under this Agreement, including Act of God, fire, flood, lightning, war,
revolution, act of terrorism, riot or civil commotion, but excluding strikes,
lock-outs or other industrial action, whether of the affected Party's own
employees or others, failure of supplies of power, fuel, transport, equipment,
raw materials or other goods or services.
"GAAP"
means United States generally accepted accounting principles, consistently
applied.
"Genentech
License" means the license agreement effective September 19, 2002
between Dyax and Genentech, Inc. ("Genentech"), a redacted copy of which
has
been provided to CAT.
"Genentech
Patent Rights" have the meaning set forth in
Schedule 9-D.
"IDE" means
an Investigational Device Exemption application, as defined in Title 21 of
the
United States Code of Federal Regulations, filed with the FDA or an equivalent
foreign filing.
6
"IND" means
an Investigational New Drug Application, as defined in Title 21 of the United
States Code of Federal Regulations, that is required to be filed with the
FDA
before beginning Phase I Clinical Trials of any Therapeutic Antibody Product
in
human subjects, or an equivalent foreign filing.
"Initial
Licence Allocation" means the [*****] Dyax
Product Licences in Clause 3.2, the up to [*****] additional Dyax Product
Licences in Clause 3.3, and the up to [*****] additional Dyax Product Licences
in Clause 3.4.
"Licensed
Intermediate" means any fusion protein (including without limitation
any chimeric binding protein), genetic package (including without limitation
any
virus, spore or cell) or other intermediate compound, or any compound derived
form any of the foregoing, that is (i) discovered, made or developed by CAT
using a method covered in whole or in part by Dyax Base Phage Display Patent
Rights or (ii) is otherwise covered by Dyax Base Phage Display Patent
Rights.
"Licensed
Product" means any product intended for sale to an End User as a human
or non-human therapeutic or in vitro diagnostic or research reagent
(and in the case of a diagnostic or research reagent contains one or more
antibodies as a binding moiety) that prior to or after December 31, 1997
(the
effective date of the Original Agreements) is discovered, made or developed,
whether by CAT, its Affiliates or any Commercial Party, using a Licensed
Intermediate or a method covered in whole or in part by the Dyax Base Phage
Display Patent Rights.
"Major
Market" means any one of the following: (i) the United States of
America, (ii) any country in Europe which is subject to the Marketing
Authorisation procedure of the European Medicines Evaluation Agency, or (iii)
Japan.
"Marketing
Authorisation" means any approval (including all applicable pricing and
governmental reimbursement approvals) required from the FDA or relevant
Competent Authority to market and sell a Product in a particular
country.
"Net
Sales" means, with respect to a Product sold by Dyax, its Affiliate or
a Dyax Sublicensee (or its sublicensees) or an Other Product sold by Dyax
, its
Affiliate or its sublicensee or with respect to a CAT Product sold by CAT,
its
Affiliate or a CAT Sublicensee (or its sublicensee), the price invoiced by
that
party to the relevant purchaser (or in the case of a sale or other disposal
otherwise than at arm's length, the price which would have been invoiced
in a
bona fide arm's length contract or sale) but deducting the costs of packing,
transport and insurance, customs duties, any credits actually given for returned
or defective Products, Other Products, CAT Products, normal trade discounts
actually given, and sales taxes, VAT or other similar tax charged on and
included in the invoice price to the purchaser.
"Nominated
Target" has the meaning set forth in Clause 4.1(a).
"Original
Agreements" means the Therapeutic Product License Agreement and the
Antibody Diagnostic License Agreement.
7
"Other
Product" has the meaning set forth in Clause 7.1.
"Other
Purposes" has the meaning set forth in Clause 7.1.
"Party"
means CAT or Dyax.
"Patent
Rights" means any patent applications and any patents issuing from such
patent applications, author certificates, inventor certificates, utility
certificates, improvement patents and models, and certificates of addition
and
all counterparts of them throughout the Territory, including any divisional
applications and patents, filings, renewals, continuations,
continuations-in-part, patents of addition, extensions, reissues, substitutions,
confirmations, registrations, revalidation and additions of or to any of
them,
as well as any supplementary protection certificates and equivalent protection
rights in respect of any of them.
"Pharmacia
Agreement" means the agreement between CAT and Pharmacia P-L
Biochemicals Inc. dated 11 September 1991.
"Pharmacia
P-L Biochemicals Inc." means Pharmacia P-L
Biochemicals Inc (now known as Amersham Biosciences).
"Phase
I Clinical Trial" means a human clinical trial in any country that is
intended to initially evaluate the safety of an investigational Product in
volunteer subjects or patients that would satisfy the requirements of 21
CFR
312.21(a), or its foreign equivalent and may evaluate the Product's therapeutic
or antigenic effects.
"Phase
II Clinical Trial" means studies in humans of the safety, dose ranging
and efficacy of a Product that would satisfy the requirements of 21 CFR
312.21(b).
"Phase
III Clinical Trial" means a pivotal human clinical trial in any country
the results of which could be used to establish safety and efficacy of a
Product
as a basis for a marketing application that would satisfy the requirements
of 21
CFR 312.21(c).
"Product"
means a Diagnostic Antibody Product or a Therapeutic Antibody
Product.
"Quarter"
means each period of three (3) months ending on March 31, June 30, September
30,
or December 31 and "Quarterly" shall be construed
accordingly.
"Research
Products" means any product in relation to which
Pharmacia P-L has an exclusive licence from CAT pursuant to the Pharmacia
Agreement.
"Reservation
Period" means the period described in Clause 4.2.
"Restatement
Date" means the date of this Agreement first
written above.
8
"Second
Amendment Agreement" means the agreement to amend the Amendment
Agreement made between CAT and Dyax dated 18 September 2003.
"Single
Domain Antibodies" means an Antibody containing only a single domain
(heavy or light).
"Specified
Diagnostic Agreements" means (i) [*****] and (iii) [*****] as such
agreements may be amended from time to time.
"Supporting
Information" means the information described in Clause
10.3.
"Target"
shall mean:
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(a)
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a
polynucleotide sequence corresponding to a sequence identified
in a
publicly available curated database such as GenBank® by means of an
accession number or similar sequence information that uniquely
identifies
that sequence; together with:
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(i)
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all
variants of the identified sequence in man and other species known
and
demonstrated to CAT or Dyax (as the case may be) at the time of
submission
to the CAT Gatekeeping Procedure or to Dyax (as the case may be)
to have
functional equivalence to (a); and
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(ii)
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all
post-transcriptional material encoded by (a) and (i) (including
splice
variants); and
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(iii)
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all
post-translational material encoded by such post-transcriptional
material;
and
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(iv)
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all
multimeric forms of (iii) irrespective of whether homomeric or
heteromeric; and
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(v)
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where
any of (iii) or (iv) is known to form a heteromeric complex with
one or
more non-identical subunits, that heteromeric complex must be identified
in its entirety at he time of submission to the CAT Gatekeeping
Procedure
or to Dyax (as the case may be) using such accession numbers of
a publicly
available curated database entry as correspond to each of the component
subunits; or
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(b)
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a
non-proteinaceous antigen that is uniquely identifiable in a routine
manner using publicly available curated databases and/or such other
suitable written material as is
available.
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"Territory"
means all countries of the world.
"Therapeutic
Antibody Product" means any preparation for the treatment or prevention
of disease, infection or other condition in humans for any indication which
contains, comprises, or the process of development or manufacture of which
utilises, a CAT Licensable Antibody. The term "Therapeutic
Antibody Product" shall not include any Research Product.
"Therapeutic
Product License Agreement" means the License
Agreement between Dyax and CAT dated 31 December 1997 relating to therapeutic
products.
9
"Third
Party" means any entity or person other than Dyax, CAT or their
respective Affiliates.
"Updates"
means the updates described in Clause 11.5.
"Valid
Claim" means a claim of an issued and unexpired
patent included within either (i) the CAT Antibody Phage Display Patents
which
have been licensed to CAT by the MRC; or (ii) the Dyax Patent Rights (as
the
case may be) which has not been held permanently revoked, unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction unappealed within the time allowed for appeal, and which has
not
been admitted to be invalid or unenforceable through reissue or disclaimer
or
otherwise.
"XOMA
Covenant" has the meaning set forth in Clause 11.2(b).
"XOMA
License" means that certain Amended and Restated License Agreement
dated October 27, 2006 by and between XOMA Ireland Limited ("XOMA") and Dyax,
a
redacted copy of which has been provided to CAT.
"XOMA
Know How" has the meaning set forth in the XOMA
License.
"XOMA
Patent Rights" has the meaning set forth in Schedule 9-E.
"Year"
means initially the period from the Commencement Date to the end of that
calendar year, and subsequently a calendar year.
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1.2
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The
headings to clauses are inserted for convenience only and shall
not affect
the interpretation or construction of this
Agreement.
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1.3
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Words
imparting the singular shall include the plural and vice versa.
References
to persons include an individual, company, corporation, firm or
partnership.
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1.4
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The
words and phrases "other", "including" and "in particular" shall
not limit
the generality of any preceding words or be construed as being
limited to
the same class as any preceding words where a wider construction
is
possible.
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1.5
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References
to any statute or statutory provisions of the United Kingdom shall
include
(i) any subordinate legislation made under it, (ii) any provision
which it
has superseded or re-enacted (whether with or without modification),
and
(iii) any provision which subsequently supersedes it or re-enacts
it
(whether with or without modification. References to any statute
or
regulation of the United States of America means that statute or
regulation as it may be amended, supplemented or otherwise modified
from
time to time, and any successor statute or
regulation.
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10
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2.1
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This
Agreement consolidates and replaces the Original Agreements, the
Amendment
Agreement the Second Amendment Agreement and the Amended and Restated
Agreement.
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2.2
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Subject
to the terms and conditions set out in this Agreement, Dyax grants
CAT and
its Affiliates a world-wide, non-exclusive, royalty free licence
(sub-licensable in accordance with the provisions of Clause 2.4)
under the
Dyax Base Phage Display Patent Rights (i) to research develop,
make, have
made, use, import, sell and have sold Licensed Products in the
Field of
Use, and (ii) to research, develop, make, and use Licensed Intermediates
in the Field of Use (a) for sale or transfer to any Commercial
Party, or
(b) for transfer to any third party who is not permitted by CAT
or its
Affiliates to commercialize such Licensed Intermediates of any
Licensed
Product.
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2.3
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CAT
acknowledges that the value of the Dyax Base Phage Display Patent
Rights
is measured in part by the value of products resulting from any
Licensed
Intermediate. CAT agrees, therefore, that it will not sell,
transfer, or otherwise make available a Licensed Intermediate to
any
Commercial Party and will not provide services or proprietary information
with respect to any Licensed Intermediate solely within the Field
of Use
to any Commercial Party, unless such Commercial Party executes
an
agreement with CAT in which such Commercial Party agrees to use
any
Licensed Intermediate solely in the Field of
Use.
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2.4
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Subject
to Clause 12.3, CAT shall have no right to grant sublicences under
the
licence to Dyax Base Phage Display Patent Rights granted to CAT
in this
Clause 2, except CAT may grant a sublicence under the Dyax Base
Phage
Display Patent Rights to any Third Party to which CAT is licensing,
selling or otherwise transferring Antibodies or Antibody Libraries
solely
for use by such Third Party with the Antibodies (including Antibodies
which are supplied to CAT by the Third Party and in relation to
which CAT
provides services to optimize that Antibody before handing the
Antibody
back to the Third Party in its optimized form) or Antibody Libraries
licensed, sold or otherwise transferred from CAT and solely for
the
purpose of developing therapeutic Antibody products or diagnostic
Antibody
products; provided that as a condition to any such sublicense,
CAT shall
require any such sublicensee to be bound by the terms of this Clause
2 and
Clause 16. For the avoidance of doubt, in no event shall CAT
have the right to sublicense the Dyax Base Phage Display Patent
Rights to
any Third Party which is a bare licensee under the CAT Antibody
Phage
Display Patents. Any Third Party which is granted a sublicense
under the Dyax Base Phage Display Patent Rights by CAT shall have
no right
to grant further sublicenses.
|
|
2.5
|
CAT
or its sublicensees shall indemnify Dyax and its Affiliates and
their
directors, officers, employees and agents and their respective
successors,
heirs and assigns (the "Dyax Indemnitees") against any liability,
damage,
loss or expense (including attorneys fees and expenses of litigation)
incurred by or imposed upon the Dyax Indemnitees or any one of
them in
connection with any claims, suits, actions, demands or judgments
by or in
favour of any Third Party concerning any manufacture, use or sale
of any
Licensed Product or Licensed Intermediate by CAT or its
sublicensee.
|
11
|
2.6
|
In
partial consideration for the grant of rights set out above CAT
agrees not
to enforce against Dyax or its Affiliates the CAT Antibody Phage
Display
Patents during the term of this Agreement that Dyax or its Affiliates
may
infringe in practicing the inventions claimed in the Dyax Patent
Rights.
|
|
3.1
|
Numbers
of Options. In accordance with this Clause 3, CAT grants to
Dyax the following options to obtain Dyax Product Licences which
may be
exercised by Dyax for itself and for Dyax
Sublicensees:
|
|
|
(a)
|
an
Initial Licence Allocation of up to [*****] Dyax Product Licences
for
Therapeutic Antibody Products and/or Diagnostic Antibody Products
shall be
available from the Commencement Date as set out in Clauses 3.2,
3.3 and
3.4;
|
|
|
(b)
|
an
Additional Licence Allocation of up to [*****] Dyax Product Licences
for
Therapeutic Antibody Products and Diagnostic Antibody Products
shall be
available from the Commencement Date as set out in Clause
3.5.
|
|
|
(c)
|
[*****]
Diagnostic Collaboration Licences for Diagnostic Antibody Products
shall
be available from the Commencement Date as set out in Clause 3.6;
and
|
|
|
(d)
|
[*****]
Additional Diagnostic Licences for Diagnostic Antibody Products
shall be
available from the Commencement Date as set out in Clause
3.7.
|
|
3.2
|
Subject
to Clauses 3.3 and 3.4, CAT hereby grants to Dyax the option for
Dyax to
obtain the following [*****] Dyax Product Licences for both Therapeutic
Antibody Products and Diagnostic Antibody Products, which may be
exercised
by Dyax only on a cumulative basis in accordance with the following
schedule:
|
|
|
(a)
|
[*****]
Dyax Product Licences on or before 31 December
2003;
|
|
|
(b)
|
[*****]
additional Dyax Product Licences on or before 31 December
2004;
|
|
|
(c)
|
[*****]
additional Dyax Product Licences on or before 31 December
2005;
|
|
|
(d)
|
[*****]
additional Dyax Product Licences on or before 31 December
2006.
|
If
the
option for any particular Dyax Product Licence set out in clauses (a) through
(d) above has not been exercised by Dyax by the relevant date, then such
unexercised options will be carried over into the next allocation period,
and so
on; provided that if any option for a Dyax Product Licence in this Clause
3.2
has not been exercised by Dyax on or before 31 December 2017, then the option
for such Dyax Product Licence will lapse irrevocably.
|
3.3
|
If
any option for a Dyax Product Licence under Clause 3.2 is exercised
and a
Dyax Product Licence is granted to Dyax, then for each Product
under any
such Dyax Product Licence which enters a Phase III Clinical Trial,
CAT
hereby grants to Dyax an additional option for one Dyax Product
Licence,
up to a maximum of [*****] additional Dyax Product Licences under
this
Clause 3.3; provided that if any option for a Dyax Product Licence
granted
in this Clause 3.3 has not been exercised by Dyax on or before
31 December
2017, then the option for such Dyax Product Licence will lapse
irrevocably.
|
12
|
3.4
|
If
any option for a Dyax Product Licence under Clause 3.2 is exercised
and a
Dyax Product Licence is granted to Dyax, then for each Product
under any
such Dyax Product Licence which fails in development or for which
Dyax
decides to terminate its program of development, CAT hereby grants
to Dyax
an additional option for one Dyax Product Licence, up to a maximum
of
[*****] additional Dyax Product Licences under this Clause 3.4;
provided
that if any option for a Dyax Product Licence granted in this Clause
3.4
has not been exercised by Dyax on or before 31 December 2017, then
the
option for such Dyax Product Licence will lapse
irrevocably.
|
|
3.5
|
In
addition to the options for Dyax Product Licences granted by CAT
to Dyax
in Clauses 3.2 to 3.4, CAT hereby grants to Dyax the option for
a total of an additional [*****] Dyax Product Licences for both
Diagnostic
Antibody Products and Therapeutic Antibody Products to be granted
to Dyax;
provided that if any option for a Dyax Product Licence in this
Clause 3.5
has not been exercised and granted to Dyax on or before 31 December
2017,
then the option for such Dyax Product Licence will lapse
irrevocably.
|
|
3.6
|
In
addition to the options for Dyax Product Licences granted by CAT
to Dyax
in Clauses 3.2 through 3.5, CAT hereby grants to Dyax the option
for a
total of an additional [*****] Dyax Product Licences for Diagnostic
Antibody Products developed by Dyax under the Specified Diagnostic
Agreements (the "Diagnostic Collaboration Licences");
provided that if any option for a Diagnostic Collaboration Licence
in this
Clause 3.6 has not been exercised by Dyax on or before 31 December
2017,
then the option for such Dyax Product Licence will lapse
irrevocably.
|
|
3.7
|
In
addition to the options for Dyax Product Licences granted by CAT
to Dyax
in Clauses 3.2 through 3.6, CAT hereby grants to Dyax the option
for a
total of an additional [*****] Dyax Product Licences for Diagnostic
Antibody Products (the "Additional Diagnostic Licences");
provided that if any option for an Additional Diagnostic Licences
has not
been exercised by Dyax on or before 31 December 2017, then the
option for
such Dyax Product Licences will lapse
irrevocably.
|
|
3.8
|
CAT
agrees that, commencing with effect from 3 January 2003, it will
not enter
into any agreement or arrangement with any Third Party whereby
a field of use under the CAT Antibody Phage Display Patents is
exclusively
licensed to, reserved for, or otherwise committed to such Third
Party. If CAT does enter into such an agreement or arrangement
it will ensure that such agreement or arrangement does not restrict
the
activities or rights of Dyax (or any potential Dyax Sublicensee
or its
sublicensee) contemplated by this Agreement. For the purposes
of this Clause, a "field of use" means one or more particular clinical
diseases or medical conditions and not one or more uniquely identified
Targets.
|
|
3.9
|
Except
as set forth in Clause 18, the options granted in this Agreement
shall not
be assigned or otherwise transferred to any Third
Party.
|
13
|
3.10
|
Prior
[*****] and provided that Dyax obtains a Dyax Product Licence for
such
Product [*****], CAT grants to Dyax, its Affiliates, and Dyax Sublicensees
(and their sublicensees) a non-exclusive, royalty free licence
in the
Territory during the term of this Agreement to use the CAT Antibody
Phage
Display Patents and the CAT Know-How for the purposes of carrying
out
research and development activities in relation to identifying
CAT
Licensable Antibodies or potential
Products.
|
|
4.1
|
If
Dyax wishes to develop and commercialise Diagnostic Antibody Products
and/or Therapeutic Antibody Products to a particular Target and
provided
that Dyax Product Licences are available to Dyax under Clause 3,
Dyax may,
at any time, in a written notice to CAT (each a
"DyaxTarget Option Notice") request that
▇▇▇ ▇▇▇▇▇ Dyax a Dyax Product Licence in relation to such identified
Target. In such Target Option Notice, Dyax
will:
|
|
|
(a)
|
identify
the relevant Target against which such CAT Licensable Antibodies
are
directed ("Nominated Target");
and
|
|
|
(b)
|
state
whether Dyax or the Dyax Sublicensee wishes to develop such CAT
Licensable
Antibodies as Diagnostic Antibody Products and/or Therapeutic Antibody
Products.
|
|
4.2
|
If
CAT notifies Dyax that the Nominated Target has passed the CAT
Gatekeeping
Procedure in accordance with Clause 4.4.1 below, then, unless otherwise
notified by Dyax, CAT will reserve such Nominated Target for Dyax
and Dyax
Sublicensee for a period of [*****] from the date of such CAT notice
("Reservation
Period"). Up to and including [*****]
Nominated Targets may be reserved in accordance with the following
procedure at any time without charge. For each additional
reservation above and beyond [*****] Nominated Targets, Dyax will
pay CAT
a reservation fee of [*****] for the next [*****] Nominated Targets
provided that no more than [*****] Nominated Targets may be reserved
at
any one time. Where such a reservation fee is payable by Dyax
it will be paid to CAT within 14 days of CAT notifying Dyax that
the
Nominated Target has passed the CAT Gatekeeping Procedure and will
be
creditable against any subsequent Acceptance Fee payable by Dyax
under a
Dyax Product Licence for that Target. Dyax may, at any time
prior to the expiry of the Reservation Period, request in writing
that CAT
extend the Reservation Period by a period of [*****]. Such
request for an extension shall be accompanied by payment of a fee
of
[*****] (the "Extension Fee"). Upon receipt by
CAT of the Extension Fee the Reservation Period for the Nominated
Target
in question will be so extended. The Extension Fee will be
creditable against any subsequent Acceptance Fee which may become
due from
Dyax to CAT under the terms of this Agreement in respect of the
same
Nominated Target. For the purposes of this Clause 4.2 "reserved
for" means that a Dyax Product Licence will continue to be available
to
Dyax and Dyax Sublicensees during that [*****] month period (or
[*****]
period if the Reservation Period is extended). Dyax may not (a)
have more than [*****] Nominated Targets reserved at any one time
and (b)
exercise the right to reserve Nominated Targets pursuant to this
Clause in
relation to more Targets than there are Dyax Product Licences remaining
available at the relevant time pursuant to Clause 3. In the
event that, at any time during which a Nominated Target is reserved
for
Dyax in accordance with this Clause 4.2, a Third Party request
from CAT an
exclusive license in respect of the relevant Nominated Target,
CAT will
promptly notify Dyax in writing. Dyax will then have a period
of [*****] days from the date of CAT's notice to decide whether
or not it
wishes to take a Dyax Product Licence for that Nominated
Target. If Dyax notifies CAT within that period that it does
not wish to take such a Dyax Product Licence or fails to notify
CAT at all
then such Nominated Target shall no longer be reserved for Dyax
and CAT
may grant an exclusive license in respect of such Nominated Target
to the
Third Party.
|
14
|
4.3
|
Upon
receipt of a Dyax Target Option Notice from Dyax under Clause 4.1,
CAT
shall have [*****] days to make a determination whether the Nominated
Target passes CAT's Gatekeeping Procedure. CAT
shall:
|
|
|
(a)
|
[*****]
|
|
|
(b)
|
[*****]
|
|
4.4
|
Before
the expiry of the [*****] referred to in Clause 4.3, CAT shall
either;
|
|
|
4.4.1
|
notify
Dyax in writing that the Nominated Target has passed the CAT Gatekeeping
Procedure, in which case, subject to the payment of applicable
Acceptance
Fee set out in Clause 8, grant to Dyax a Dyax Product Licence to
Exploit
Products against such Nominated Target in the Territory;
or
|
|
|
4.4.2
|
notify
Dyax in writing that the Nominated Target has not passed the CAT
Gatekeeping Procedure, in which case Dyax shall have no right to
obtain a
Dyax Product Licence to Exploit Products against such Nominated
Target in
the Territory.
|
|
4.5
|
CAT
agrees that:
|
|
|
(a)
|
CAT
will treat Dyax in the same way as CAT treats its other customers,
collaborators and licensees when applying the procedure described
in this
Clause 4; and
|
|
|
(b)
|
CAT
will only disclose information received by it from Dyax in relation
to a
Nominated Target to those CAT employees who need to know such information
for the purposes of this Clause 4. Any such information will be
deemed to be Confidential Information of
Dyax
|
4.6 In
the case where a CAT Licensable Antibody is directed to two Targets (a
"Bi-Specific Antibody"), or more than two Targets (a
"Poly-Specific Antibody") the Target Option Notice shall
identify each relevant Target against which such Bi-Specific Antibody or
Poly-Specific Antibody is directed, and each such Target shall be considered
a
Nominated Target. If CAT notifies Dyax that each Nominated Target to
which such Bi-Specific Antibody or Poly-Specific Antibody is directed has
passed
the CAT Gatekeeping Procedure, Dyax shall have the right to obtain a Dyax
Product Licence with respect to each such Nominated Target; provided however,
that such Dyax Product Licence shall be limited so as to allow Dyax to Exploit
only Products to such Nominated Targets that comprise or contain the Bi-Specific
Antibody or Poly-Specific Antibody, which shall be clearly identified in
the
Dyax Product Licence. For the avoidance of doubt, the parties
acknowledge that:
15
|
|
(a)
|
Dyax
may obtain a Dyax Product Licence for Therapeutic Antibody Products
and
Diagnostic Antibody Products containing or comprising such Bi-Specific
Antibodies against two Nominated Targets or Poly-Specific Antibodies
against more than two Nominated Targets by exercising only one
(1) option
from among the Initial Licence Allocation under Clauses 3.2 to
3.4 and the
Additional Licence Allocation under Clause
3.5;
|
|
|
(b)
|
in
the event that Dyax request that CAT reserve such Nominated Targets
for
the Reservation Period all such Nominated Targets will count towards
the
maximum of [*****] Nominated Targets which may be reserved by Dyax
at one
time pursuant to Clause 4.2; and
|
|
|
(c)
|
in
the event that Dyax request that the Reservation Period for any
such
Nominated Targets be extended for six (6) months then Dyax will
pay an
Extension Fee for each such Nominated
Target.
|
|
5.1
|
To
Dyax. In the event CAT notifies Dyax under Clause 4.4.1
above that a Nominated Target has passed the CAT Gatekeeping Procedure,
then upon receipt by CAT of the applicable Acceptance Fee, CAT
agrees to
grant and hereby grants to Dyax and its Affiliates a non-exclusive,
royalty-bearing license, with the right to sublicense, under the
CAT
Antibody Phage Display Patents and CAT Know-How to Exploit Products
against such Nominated Target in the Territory ("Dyax Product
Licence"). Any Dyax Product Licence granted to Dyax
shall be consistent with the terms of this Clause 5 and Clauses
6, 8, 9,
17 and 19 of this Agreement and shall be negotiated by the Parties
in good
faith; provided, however, that the Parties agree that the terms
and
conditions and the form of any Dyax Product Licence executed after
the
Effective Date of this Agreement shall be substantially similar
to the
form attached hereto as Schedule 7.
|
|
5.2
|
The
Parties agree that Dyax may obtain a Dyax Product Licence for Therapeutic
Antibody Products and Diagnostic Antibody Products against the
same
Nominated Target by exercising only one (1) option from among the
Initial
Licence Allocation under Clauses 3.2 to 3.4 and the Additional
Licence
Allocation under Clause 3.5.
|
|
5.3
|
Nothing
herein shall prevent CAT from meeting any obligations it has to
Third
Parties under any agreements in respect of any Nominated Target
for which
Dyax submits a Target Option Notice under Clause 4.1 where such
Nominated
Target is determined by CAT under Clause 4 not to pass the CAT
Gatekeeping
Procedure, provided that such obligation does not involve any use
or
disclosure of any Confidential Information belonging to
Dyax.
|
|
5.4
|
Dyax
must request, and be granted, a Dyax Product
Licence;
|
|
|
5.4.1
|
in
relation to a Therapeutic Antibody Product prior to [*****];
or
|
16
|
|
5.4.2
|
in
relation to a Diagnostic Antibody Product prior to
[*****].
|
For
the
avoidance of doubt, the parties acknowledge and agree that a Dyax Partner
or
Dyax Sublicensee may obtain rights under the CAT Antibody Phage Display Patents
and CAT Know-How to Exploit Products against a Target in the Territory without
obtaining rights under a Product License if such Dyax Partner or Dyax
Sublicensee obtains such rights under a written agreement directly with
CAT.
|
5.5
|
Any
Dyax Product Licence which may be granted by CAT to Dyax shall
not be
effective until the receipt by CAT of the relevant Acceptance Fee,
which
shall not be refundable or creditable against any other sums which
may be
payable by Dyax or a Dyax Sublicensee to CAT pursuant to this
Agreement.
|
|
5.6
|
Dyax
will, if requested by CAT, inform CAT of the identity of all Dyax
Sublicensees (and their sublicensees) in relation to each Dyax
Product
Licence.
|
|
5.7
|
Dyax
(and where relevant each Dyax Sublicensee) will ensure that any
sublicensee (to which it sublicences its rights in accordance with
the
terms of this Agreement) executes a written agreement (a) which
requires
the sublicensee to abide by the terms of one or more specified
Dyax
Product Licences or (b) which is consistent with the terms of Clauses
3.10
or 7, and Clauses 4, 5.5, and 5.8 of this Agreement and for the
purposes
of sublicences relating to Other Products only Clauses 8.4, 8.6,
8.8, 8.9,
8.10 and 9.2 through to 9.7.
|
|
5.8
|
Dyax
shall be entitled to sublicense its rights under a Dyax Product
Licence to
one or more Dyax Sublicensees. Furthermore, each Dyax
Sublicensee may also sublicense to any Third Party and so on provided
each
such sublicence is granted in accordance with Clause 5.7
above. [*****].
|
Each Dyax Product Licence granted to Dyax by
CAT shall include the following terms:
|
6.1
|
The
Dyax Product Licence shall grant rights under the CAT Antibody
Phage
Display Patents and CAT Know-How and, for the avoidance of doubt,
no
rights shall be granted by CAT in any Dyax Product Licence to any
CAT
Diabodies Patent Rights, and any Patent Rights owned or controlled
by CAT
which claim Catalytic Antibodies, ribosome display technology,
any Patent
Rights which claim Single Domain Antibodies and no rights shall
be granted
by CAT in any Dyax Product Licence under the Antibody Phage Display
Patents to Exploit Research
Products.
|
|
6.2
|
The
Dyax Product Licence shall come into effect upon the date that
the
Acceptance Fee is paid and the Dyax Product Licence shall be subject
to
the applicable terms of Clause 8;
|
|
6.3
|
Unless
terminated under Clause 6.10, Clause 6.11 or Clause 6.12, the Dyax
Product
Licence shall continue, on a country-by-country and Product-by-Product
basis until the last Valid Claim of the CAT Antibody Phage Display
Patents
expires, or ten (10) years after First Commercial Sale of such
Product in
the country of sale, whichever occurs
later;
|
17
|
6.4
|
Dyax
and each Dyax Sublicensee (or its sublicensee) shall indemnify
CAT and its
Affiliates and their directors, officers, employees and agents
and their
respective successors, heirs and assigns (the "CAT Indemnitees")
against
any liability, damage, loss or expense (including attorneys fees
and
expenses of litigation) incurred by or imposed upon the CAT Indemnitees
or
any one of them in connection with any claims, suits, actions,
demands or
judgments by or in favour of any Third Party concerning any manufacture,
use or sale of any Product by Dyax or such Dyax Sublicensee (or
its
sublicensee);
|
|
6.5
|
CAT
shall not be liable to any Dyax and Dyax Sublicensee (or its sublicensee)
in respect of any liability, loss, damage or expense (including
attorneys
fees and expenses of litigation) incurred or suffered by Dyax and
any Dyax
Sublicensees (or its sublicensee) in connection with the manufacture,
use
or sale of any Products by Dyax and Dyax Sublicensees (or its
sublicensee);
|
|
6.6
|
CAT
provides no warranty or representation from CAT that the CAT Antibody
Phage Display Patents are, or will be, valid or that the exercise
of the
rights granted under the Dyax Product Licence will not result in
the
infringement of patents of Third
Parties;
|
|
6.7
|
Dyax
shall notify CAT promptly of any proceedings or applications for
revocation of any of the CAT Antibody Phage Display Patents emanating
from
a Third Party that comes to its notice or if a Third Party takes
or
threatens to take any proceedings for infringement of any patents
of that
Third Party by reason of Dyax's use or operation of the CAT Antibody
Phage
Display Patents or manufacture, use or sale of the
Products. Dyax shall notify CAT promptly of any infringement of
the CAT Antibody Phage Display Patents by a Third Party which may
come to
its attention during the term of the Dyax Product Licence, except
Dyax
shall have no obligation to so notify CAT with respect to any infringement
by an academic or not-for-profit entity which occurs by reason
of such
entity carrying out research activities provided such activities
are, as
far as Dyax is aware, not being carried out with a view to commercialising
a product or otherwise for profit;
|
|
6.8
|
CAT
shall have the sole right and responsibility, at its sole discretion
and
cost and with reasonable assistance from Dyax, to file, prosecute
and
maintain the CAT Antibody Phage Display Patents and for the conduct
of any
lawsuits, claims or proceedings challenging the validity or enforceability
thereof including, without limitation, any interference or opposition
proceeding relating thereto in all countries. For the avoidance
of doubt, Dyax and Dyax Sublicensees will have the right to conduct
any
proceedings relating to its Product including any proceedings relating
to
product liability;
|
|
6.9
|
Dyax
and any Dyax Sublicensee may assign the benefit and/or burden of
any Dyax
Product Licence to any Affiliate or Third Party, provided that
such
Affiliate or Third Party undertakes to CAT to be bound by the terms
of the
Dyax Product Licence;
|
|
6.10
|
CAT
shall have the right to terminate any Dyax Product Licence in the
event
that:
|
|
6.10.1
|
Dyax
or a Dyax Sublicensee (or its sublicensee) has not filed an IND
for a
Therapeutic Antibody Product, or a 510(k) or IDE for a Diagnostic
Antibody
Product within [*****] after the grant of that Dyax Product Licence;
provided however, that Dyax shall have the right to extend such
period in
annual increments by up to [*****], upon the following
terms:
|
|
First
Annual Extension
|
$[*****]
|
|
Second
Annual Extension
|
$[*****]
|
In
order
for Dyax to be granted an extension under this Clause 6.10.1, the foregoing
amounts must be received by CAT prior to the date of expiration. All
amounts received by CAT under this Clause 6.10.1 will be credited against
any
milestones and royalties that would otherwise be due to CAT under the terms
of
the Product License; or
|
6.10.2
|
Dyax
or a Dyax Sublicensee (or its sublicensee) directly or indirectly
opposes
or assists any Third Party to oppose the grant of letters patent
or any
patent application within the CAT Antibody Phage Display Patents,
or
disputes or directly or indirectly assists any Third Party to dispute
the
validity of any patent within the CAT Antibody Phage Display Patents
or
any of the claims thereof.
|
|
6.11
|
In
the event that either Party commits a material breach of any of
its
obligations with respect to a Dyax Product Licence, and such Party
fails
to remedy that breach within ninety (90) days after receiving written
notice thereof from the other Party, that other Party may immediately
terminate the Dyax Product Licence upon written notice to the breaching
Party.
|
|
6.12
|
Either
Party may terminate a Dyax Product Licence in its entirety by giving
notice in writing to the other Party if any one or more of the
following
events happens:
|
|
|
(a)
|
the
other Party has any distress or execution levied on the major portion
of
its assets (as determined by its balance sheet in accordance with
GAAP)
which is not paid out within thirty (30) days of its being
levied;
|
|
|
(b)
|
the
other Party calls a meeting for the purpose of passing a resolution
to
wind it up, or such a resolution is passed, or the other Party
presents,
or has presented, a petition for a winding up order, or presents,
or has
presented, a petition to appoint an administrator, or has an
administrative receiver, or receiver, liquidator or other insolvency
practitioner appointed over all or any substantial part of its
business,
undertaking, property or assets;
|
|
|
(c)
|
the
other Party stops or suspends making payments (whether of principal
or
interest) with respect to substantially all of its debts or announces
an
intention to do so or the other Party suspends or ceases to carry
on its
business;
|
|
|
(d)
|
a
secured lender to the other Party holding a security interest over
the
major portion of the tangible assets (as determined by its balance
sheet
in accordance with GAAP) of such other Party takes any steps to
obtain
possession of the property on which it has security or otherwise
to
enforce its security; or
|
18
|
|
(e)
|
the
other Party suffers or undergoes any procedure analogous to any
of those
specified in Clause 6.12(a) - (d) above or any other procedure
available
in the country in which the other Party is constituted, established
or
domiciled against or to an insolvent debtor or available to the
creditors
of such a debtor.
|
|
7.2
|
The
licence granted in Clause 7.1 does not include any grant by CAT
of rights
to CAT Diabodies Patent Rights, or Patent Rights owned or controlled
by
CAT which claim Catalytic Antibodies, or ribosome display technology
or
Patent Rights which claim Single Domain Antibodies or any use of
the said
Patent Rights in the field of Research Products. Dyax's rights
under the licence granted in Clause 7.1 are expressly subject to
any
rights which CAT has granted to any Third Party prior to 3 January
2003 or
may grant to any Third Party after 3 January 2003 provided that
any rights
granted by CAT to any Third Party after 3 January 2003 shall not
restrict
the freedom of Dyax or Dyax Sublicensees (or their sublicensees)
to
operate under any agreement entered into by them prior to the date
CAT
grants such Third Party rights.
|
|
7.3
|
In
the event that either Party commits a material breach of any of
its
obligations with respect to the licence granted in Clause 7.1,
and such
Party fails to remedy that breach within ninety (90) days after
receiving
written notice thereof from the other Party, that other Party may
immediately terminate the licence upon written notice to the breaching
Party.
|
|
7.4
|
Either
Party may terminate a licence set out in Clause 7.1 above in its
entirety
by giving notice in writing to the other Party if any one or more
of the
following events happens:
|
|
|
(a)
|
the
other Party has any distress or execution levied on the major portion
of
its assets (as determined by its balance sheet in accordance with
GAAP)
which is not paid out within thirty (30) days of its being
levied;
|
|
|
(b)
|
the
other Party calls a meeting for the purpose of passing a resolution
to
wind it up, or such a resolution is passed, or the other Party
presents,
or has presented, a petition for a winding up order, or presents,
or has
presented, a petition to appoint an administrator, or has an
administrative receiver, or receiver, liquidator or other insolvency
practitioner appointed over all or any substantial part of its
business,
undertaking, property or assets;
|
19
|
|
(c)
|
the
other Party stops or suspends making payments (whether of principal
or
interest) with respect to substantially all of its debts or announces
an
intention to do so or the other Party suspends or ceases to carry
on its
business;
|
|
|
(d)
|
a
secured lender to the other Party holding a security interest over
the
major portion of the tangible assets (as determined by its balance
sheet
in accordance with GAAP) of such other Party takes any steps to
obtain
possession of the property on which it has security or otherwise
to
enforce its security;
|
|
|
(e)
|
the
other Party suffers or undergoes any procedure analogous to any
of those
specified in Clause 7.4(a) – (d) above or any other procedure available in
the country in which the other Party is constituted, established
or
domiciled against or to an insolvent debtor or available to the
creditors
of such a debtor;
|
|
|
8.1.1
|
With
respect to each Dyax Product Licence from the Initial Licence Allocation
for Therapeutic Antibody Products for a Nominated Target, Dyax
shall pay
to CAT the following payments upon achievement of the specified
milestones
by Dyax or a Dyax Sublicensee (or its sublicensee) for the first
Therapeutic Antibody Product directed against such Nominated Target
to
achieve the relevant milestone:
|
|
Acceptance
Fee (if not already paid for that Nominated Target pursuant to
Clause
8.3.1)
|
US
$[*****]
|
|
Initiation
of first Phase I Clinical Trial
|
US
$[*****]
|
|
Initiation
of first Phase III Clinical Trial
|
US
$[*****]
|
|
First
filing for Marketing Authorisation in one Major Market
country
|
US
$[*****]
|
|
Marketing
Authorisation granted in the United States
|
US
$[*****]
|
|
|
8.1.2
|
With
respect to Dyax Product Licences for a Therapeutic Antibody Product
from
the Initial Licence Allocation, Dyax shall pay CAT royalties in
an amount
equal to [*****] of Net Sales of the Therapeutic Antibody Product
sold by
or on behalf of Dyax or the Dyax
Sublicensee.
|
20
|
|
8.2.1
|
With
respect to each Dyax Product Licence from the Additional Licence
Allocation set forth in Clause 3.5 for Therapeutic Antibody Products
for a
Nominated Target, Dyax shall pay to CAT the following payments
upon
achievement of the specified milestones by Dyax or a Dyax Sublicensee
(or
its sublicensee) for the first Therapeutic Antibody Product directed
against such Nominated Target to achieve the relevant
milestone:
|
|
Acceptance
Fee (if not already paid for that Nominated Target pursuant to
Clause
8.3.1)
|
US
$[*****]
|
|
Initiation
of first Phase I Clinical Trial
|
US
$[*****]
|
|
Initiation
of first Phase III Clinical Trial
|
US
$[*****]
|
|
First
filing for Marketing Authorisation in one Major Market
country
|
US
$[*****]
|
|
First
Marketing Authorisation granted in one Major Market
country
|
US
$[*****]
|
|
|
8.2.2
|
With
respect to each Dyax Product Licence from the Additional Licence
Allocation set forth in Clause 3.5 for Therapeutic Antibody Products,
Dyax
will pay CAT royalties in an amount equal to [*****] of Net Sales
of the
Therapeutic Antibody Product sold by or on behalf of Dyax or the
Dyax
Sublicensee. Such royalty rate shall apply to the four Dyax
Product Licences which CAT and Dyax have already executed before
the date
of this Agreement and which were taken from the
[*****].
|
|
|
8.3.1
|
With
respect to each Dyax Product Licence for Diagnostic Antibody Products,
Dyax shall pay to CAT the following payments upon achievement by
Dyax or a
Dyax Sublicensee (or its sublicensee) of the milestones set out
below. For the avoidance of doubt the milestone payments shall
be payable in respect of the first Diagnostic Antibody Product
directed
against each Nominated Target to achieve the relevant
milestone:
|
|
Acceptance
Fee (if not already paid for that Nominated Target pursuant to
Clause
8.1.1 or 8.2.1)
|
US
$[*****]
|
|
First
filing for Marketing Authorisation in one Major Market
country
|
US
$[*****]
|
|
Marketing
Authorisation granted in each Major Market Country
|
US
$[*****]
|
|
|
8.3.2
|
Notwithstanding
the foregoing, the parties acknowledge and agree that no milestone
payments will be payable by Dyax Sublicensee to CAT in respect
of
Diagnostic Antibody Products developed under the Specified Diagnostic
Agreements.
|
|
|
8.3.3
|
With
respect to each Dyax Product Licence for a Diagnostic Antibody
Product,
Dyax shall pay CAT royalties on a country-by-country basis in an
amount
equal to [*****] of Net Sales of Diagnostic Antibody Products sold
by or
on behalf of Dyax or any Dyax
Sublicensee.
|
|
8.4
|
Other
Products. With respect to each Other Product developed by
Dyax or one of its sublicensees under Clause 7, Dyax or its sublicensee,
as the case may be, shall pay CAT royalties on a country-by-country
basis
in an amount equal to [*****] of Net Sales of each Other Product
sold by
or on behalf of Dyax or the Dyax Sublicensee in the
Territory.
|
21
|
8.5
|
In
addition to the royalty payments in Clause 8.4, and subject to
Clause
8.7.3, Dyax will pay to CAT [*****] of all other sums received
by Dyax in
relation to Other Products or any Other Purposes under sublicense
agreements executed after the Commencement Date. For the
avoidance of doubt, the sums payable by Dyax shall include [*****]
of any
sums that Dyax receives from a sublicensee from any further sublicensing
but CAT shall not receive [*****] of the sum actually received
by such a
sublicensee from such further sublicensing. Dyax shall be
entitled to retain all amounts that it receives from sublicensees
in
payment for the provision of support services relating to the supply
of
CAT Antibody Libraries or Antibodies derived therefrom as reasonably
calculated based on the use of Full Time Equivalents, machine hours,
other
comparable cost based measures or any combination of the
foregoing.
|
|
8.6
|
For
the further avoidance of doubt, Dyax or its sublicensee will retain
all
non-royalty payments made to Dyax by sublicensees of Other Products
under
agreements executed prior to 3 January
2003.
|
|
8.7
|
The
Parties hereby agree that, notwithstanding any provision of this
Agreement
(including without limitation Clauses 8.4, 8.5 and 8.6 of this
Agreement),
with respect to any [*****] used for [*****] that is developed
under that
certain Development and License Agreement between Dyax and a Third
Party
dated [*****] (the "Development and License Agreement"),
Dyax's sole obligation to CAT is to pay to CAT [*****] of all royalties,
milestones and other sums (including any consideration in kind)
received
by Dyax in relation to such [*****] product, except that Dyax shall
not
pay to CAT any percentage of Full Time Equivalent based funded
research
payments received by Dyax under the Development and License
Agreement.
|
|
|
8.8.1
|
In
respect of any agreements concluded between Dyax and any Dyax Partner
before 3 January 2003 under which CAT Antibody Libraries or Antibodies
derived therefrom are made available to such Dyax Partner, the
Parties
agree that: (a) Dyax will retain all amounts (including without
limitation
all Antibody Library transfer fees) that it receives in payment
from such
Dyax Partner prior to the grant of a Dyax Product Licence; (b)
Dyax will
retain all amounts that it receives in payment from such Dyax Partner
after the grant of a Dyax Product Licence hereunder, exclusive
of any
amounts payable on account of such Dyax Partner's obligation to
pay any
milestone payments or royalties to CAT for any Therapeutic Antibody
Product or Diagnostic Antibody Product under the terms of such
Dyax
Product Licence.
|
|
|
8.8.2
|
In
respect of any agreements concluded between Dyax and any Dyax Partner
after 3 January 2003 of this Agreement under which CAT Antibody
Libraries
or Antibodies derived therefrom are made available to such Dyax
Partner,
the Parties agree that: (a) Dyax shall be entitled to retain all
amounts
that it receives from such Dyax Partner in payment for the provision
of
support services relating to the supply of the CAT Antibody Libraries
or
Antibodies derived therefrom as reasonably calculated based on
the use of
Full Time Equivalents, machine hours, other comparable cost-based
measures
or any combination of the foregoing; and (b) all other amounts
(including
without limitation all Antibody Library transfer fees) that Dyax
receives
in payment from such Dyax Partner with respect to development of
a Product
during the period before the grant of a Dyax Product Licence hereunder
will be divided in the proportion [*****] to Dyax and [*****] to
CAT. After the grant of a Dyax Product Licence for a Product
CAT shall only be entitled to payments under the Dyax Product Licence
for
such Product and no further amounts shall be payable under this
Clause
8.9.2.
|
22
|
|
8.8.3
|
The
provisions of this Clause 8.8 shall not apply to Other Products,
which
shall be handled solely in accordance with Clauses 8.4, 8.5 and
8.6
above.
|
|
8.9
|
All
royalties due to CAT under Clauses 8.1.2, 8.2.2, 8.3.2, 8.4 or
sums due to
CAT in respect of any Other Product or any Other Purpose under
Clause 8.5
or any other sums due to CAT under Clause 8.8.2 shall be payable
on a
country-by-country basis until the last Valid Claim of a CAT Antibody
Phage Display Patent expires or ten (10) years from the date of
First
Commercial Sale of such Product or Other Product or Other Purpose,
whichever occurs later.
|
|
8.10
|
Dyax
agrees that it will not, without the prior written consent of CAT,
receive
shares or any other non-cash consideration in return for granting
any
sublicence to a Dyax Sublicensee. Dyax will ensure that each
Dyax Sublicensee will also not receive any shares or any other
non-cash
consideration when granting a sublicence pursuant to the terms
of its
sublicence agreement.
|
|
8.11
|
Dyax
shall be free to make CAT Antibody Libraries and Antibodies derived
from
CAT Antibody Libraries available to any Dyax Sublicensee and the
latter
will be free to use the foregoing without any further licence from
CAT
under the CAT Antibody Phage Display Patents; provided that (i)
any
amounts paid to Dyax from any such Dyax Sublicensee will be dealt
with in
accordance with Clause 8.5 or 8.8, and (ii) such Dyax Sublicensees
will
only be able to Exploit any Product derived from such CAT Antibody
Libraries or such Antibodies if a Dyax Product Licence has been
sublicensed to them by Dyax.
|
|
8.12
|
The
Parties agree that any payments already made by Dyax to CAT under
the
terms of the Amendment Agreement are not affected by the terms
of this
Agreement.
|
|
9.1
|
All
milestone payments shall be paid by Dyax within [*****] days of
the
applicable milestone being achieved and no milestone payments shall
be
refundable or creditable against any other sum payable by Dyax
hereunder
for any reason.
|
23
|
9.2
|
Dyax
shall make the payments due to CAT under Clause 8 above in United
States
dollars (if Dyax in turn receives payment in dollars) or in pounds
sterling (if Dyax in turn receives payment in pound sterling),
or Euros
(if Dyax in turn receives payment in Euros). Where Dyax
receives payment in a currency other than United States dollars,
pounds
sterling or Euros, Dyax will convert the relevant sum into pounds
sterling
(or Euros if Euros have replaced pounds sterling at the time of
payment). Dyax will use the conversion rate reported in the
Financial Times two (2) Business Days before the day on which Dyax
pays
CAT. Such payment will be made without deduction of exchange,
collection or other charges. All payments will be made at
Quarterly intervals. Within [*****] days of the end of each
Quarter after the First Commercial Sale of each Product, or Other
Product
in any country, Dyax shall prepare a statement which shall show
on a
country-by-country basis for the previous Quarter Net Sales of
each
Product, or Other Product by Dyax or its Affiliates and all monies
due to
CAT based on such Net Sales. That statement shall include
details of Net Sales broken down to show the country of the sales
and the
total Net Sales by Dyax or its Affiliates in such country and shall
be
submitted to CAT within such [*****] day period together with remittance
of the monies due. With respect to Net Sales of a Product or
Other Product by a Dyax Sublicensee (or its sublicensee) Dyax shall
prepare a statement which will include the same information and
remit that
statement and any monies due within the same period except with
regard to
any Dyax Sublicensee with which Dyax has a licence agreement relating
to
the technology of Antibody phage display as of or prior to the
Commencement Date where the remittance will be made at Quarterly
intervals
within [*****] days of the date royalties are due to Dyax from
such
existing Dyax Sublicensees. With respect to any other sums
received by Dyax in accordance with Clauses 8.5 and 8.7.2
Dyax shall within [*****] days of the end of the first Quarter
in which Dyax receives such sums prepare and submit to CAT a statement,
which shall include details of all such sums received by Dyax on
a country
by country basis in the previous Quarter, together with
remittance of any monies due.
|
|
9.3
|
All
payments shall be made free and clear of and without deduction
or
deferment in respect of any disputes or claims whatsoever and/or
as far as
is legally possible in respect of any taxes imposed by or under
the
authority of any government or public
authority. [*****].
|
|
9.4
|
Dyax
shall keep and shall procure that its Affiliates and Dyax Sublicensees
keep true and accurate records and books of account containing
all data
necessary for the calculation of the amounts payable by it to CAT
pursuant
to this Agreement. Those records and books of account shall be
kept for seven (7) years following the end of the Year to which
they
relate. Upon CAT's written request, a firm of accountants
appointed by agreement between the Parties or, failing such agreement
within ten (10) Business Days of the initiation of discussions
between
them on this point CAT shall have the right to cause an international
firm
of independent certified public accountants that has not performed
auditing or other services for either Party or their Affiliates
(or, if
applicable, any Dyax Sublicensee with rights to the Product in
question)
acceptable to Dyax or the Dyax Sublicensee such acceptance not
to be
unreasonably withheld to inspect such records and books of
account. In particular such
firm:
|
|
|
9.4.1
|
shall
be given access to and shall be permitted to examine and copy such
books
and records of Dyax and its Affiliates and Dyax Sublicensees upon
twenty
(20) Business Days notice having been given by CAT and at all reasonable
times on Business Days for the purpose of certifying that the Net
Sales or
other relevant sums calculated by Dyax and its Affiliates and Dyax
Sublicensees during any Year were reasonably calculated, true and
accurate
or, if this is not their opinion, certify the Net Sales figure
or other
relevant sums for such period which in their judgment is true and
correct;
|
24
|
|
9.4.2
|
prior
to any such examination taking place, such firm of accountants
shall
undertake to Dyax that they shall keep all information and data
contained
in such books and records, strictly confidential and shall not
disclose
such information or copies of such books and records to any third
person
including CAT, but shall only use the same for the purpose of calculations
which they need to perform in order to issue the certificate to
which this
Clause envisages;
|
|
|
9.4.3
|
any
such access examination and certification shall occur no more than
once
per Year and will not go back over records more than two (2) years
old;
|
|
|
9.4.4
|
Dyax
and its Affiliates and Dyax Sublicensees shall make available personnel
to
answer queries on all books and records required for the purpose
of that
certification; and
|
|
|
9.4.5
|
the
cost of the accountant shall be the responsibility of Dyax if the
certification shows it to have underpaid monies to CAT by more
than
[*****] and the responsibility of CAT
otherwise.
|
|
9.5
|
All
payments due to CAT under the terms of this Agreement are expressed
to be
exclusive of value added tax (VAT) howsoever arising.
[*****].
|
|
9.6
|
All
payments made to CAT under this Agreement shall be made to the
bank
account of CAT as notified by CAT to Dyax from time to
time.
|
|
9.7
|
If
Dyax fails to make any payment to CAT hereunder on the due date
for
payment, without prejudice to any other right or remedy available
to CAT
it shall be entitled to charge Dyax interest (both before and
after judgment) of the amount unpaid at the annual rate of LIBOR
(London
Interbank Offering Rate) plus [*****] calculated on a daily basis
until
payment in full is made without prejudice to CAT's right to receive
payment on the due date.
|
|
10.1.1.
|
In
the event that Dyax undertakes development of any Dyax Therapeutic
Antibody Product on its own and then subsequently decides to fully
licence-out the further development and commercialisation of such
Dyax
Therapeutic Antibody Product to a Third Party prior to the filing
of the
first IND for such Dyax Therapeutic Antibody Product ("Development
Licence"), then before granting such license to such Third Party,
Dyax shall first offer CAT in writing the option to obtain a license
to
continue the development and commercialisation of such Dyax Therapeutic
Antibody Product in the Territory (a "Development Licence
Option"). As used in this Clause 10.1.1, the term
"licence-out" shall apply only to Third Party license agreements
in which
Dyax will not retain any operational control or funding obligations
with
respect to the ongoing development and commercialisation of such
Dyax
Therapeutic Antibody Product.
|
25
|
10.1.2.
|
For
the avoidance of doubt, if Dyax decides to licence the further
development
and commercialisation of any Dyax Therapeutic Antibody Product
to a Third
Party after the filing of the first IND for such Dyax Therapeutic
Antibody
Product, it shall give CAT the option to participate in the bidding
process for such a licence but Dyax shall have no obligation to
offer CAT
a Development Licence with respect
thereto.
|
|
10.2
|
CAT
acknowledges and agrees that, from time to time, the license out
by Dyax
of a Dyax Therapeutic Antibody Product may be strategically combined
with
one or more other Dyax Therapeutic Antibody Products or with products
and
services offered by Dyax, and that in such cases, CAT's Development
Licence Option may only be exercised by agreeing to
all of the terms relevant to such strategic combination. If (i)
any Development Licence Option offered to CAT contains such a combination;
and (ii) CAT and Dyax do not enter into a Development Licence pursuant
to
such Development Licence Option in accordance with the provisions
of
Clause 10.5 below; and (iii) Dyax subsequently decide to alter
the
combination (for example add or take away a product or service)
which is
to be the subject of the Development Licence, such altered combination
must be offered to CAT in accordance with Clause 10.1.1 above and
Clauses
10.2 to 10.6 below shall
apply.
|
|
10.3
|
The
written notification by Dyax to CAT of a Development Licence Option
(a
"Development Licence Option Notice") shall set out the
general terms upon which Dyax is willing to grant a Development
Licence,
and it shall be accompanied by all reasonable and relevant scientific,
regulatory and technical information relating to the Dyax Therapeutic
Antibody Product that is the subject of the Development Licence
Option
Notice (the "Supporting Information") so that CAT can
reasonably determine in its sole discretion whether to enter into
a
Development Licence.
|
|
10.4
|
CAT
shall notify Dyax within [*****] days of receipt of the Development
Licence Option Notice and all Supporting Information (or such other
longer
period as the Parties agree) whether or not it wishes to enter
into a
Development Licence. If CAT notifies Dyax that it does not wish
to enter into a Development Licence, or CAT does not respond to
Dyax
within the foregoing period, then Dyax shall be free to develop
and
commercialise the Dyax Therapeutic Antibody Product that was the
subject
of the Development Licence Option Notice with any Third Party;
provided
that Dyax shall not enter into such a Development Licence on terms
which,
taken as a whole, are more favourable to the Third Party then those
set
out in the Development Licence Option Notice without first offering
such
more favourable terms to CAT.
|
|
10.5
|
If
CAT wishes to enter into a Development Licence, the Parties shall
forthwith negotiate the terms of such Development Licence in good
faith. If the Parties acting reasonably and in good faith are
unable to agree the heads of terms of the Development Licence within
[*****] months of commencing negotiations, then Dyax shall be
free to enter into a Development Licence with any Third Party for
the Dyax
Therapeutic Antibody that was the subject of the Development Licence
Option Notice; provided that Dyax shall not enter into such a Development
Licence on terms which, taken as a whole, are more favourable to
the Third
Party then those set out in the Development Licence Option Notice
without
first offering such more favourable terms to
CAT.
|
26
|
10.6
|
The
provisions of this Clause 10 shall apply to all Dyax Therapeutic
Antibody
Products.
|
|
10.7
|
For
the avoidance of doubt Dyax shall be free to enter into co-development
agreements with any Third Party with respect to any Therapeutic
Antibody
Product without first offering any rights to such product to
CAT. If however any proposed co-development agreement changes
in nature during negotiations between Dyax and the relevant Third
Party to
being one of a licence-out the provisions of 10.1 to 10.5 above
will
apply. In addition, if having entered into a co-development
agreement with a Third Party with respect to any Therapeutic Antibody
Product, such agreement is terminated and Dyax decides to out license
the
further development and commercialisation of such product, the
provisions
of Clauses 10.1 to 10.5 above will
apply.
|
|
11.1
|
Dyax
grants to CAT and its Affiliates a non-exclusive, non-sublicensable
licence to use the Dyax Antibody Library, Dyax Materials, Dyax
Know-How
and the inventions claimed in the Dyax Patent Rights for the purposes
of
carrying out research and development activities in relation to
identifying Dyax Licensable Antibodies or potential CAT Products
from the
Dyax Antibody Library. Such licence shall commence on the date
the Dyax Materials are received by CAT pursuant to Clause 11.3
below and
continue for a period of [*****].
|
|
11.2
|
Dyax
also grants to CAT and its Affiliates the following rights to Third
Party
intellectual property:
|
|
|
(a)
|
Affimed
Sublicense. Upon the terms and conditions set forth
in Schedule 10-A, CAT shall have a sublicense under the Affimed
Patent
Rights (the "Affimed Sublicense") for use with the Dyax Antibody
Library
as permitted by the license granted in Clause
11.1.
|
|
|
(b)
|
Biosite
Sublicense. Upon the terms and conditions set forth
in Schedule 10-B, CAT shall have a sublicense under the Biosite
Patent
Rights (the "Biosite Sublicense") for use with the Dyax Antibody
Library
as permitted by the license granted in Clause
11.1.
|
|
|
(c)
|
Domantis
Sublicense. Upon the terms and conditions set forth
in Schedule 10-C, CAT shall have a sublicense under the Domantis
Patent
Rights and the Domantis Know How (the "Domantis Sublicense") for
use with
the Dyax Antibody Library as permitted by the license granted in
Clause
11.1.
|
|
|
(d)
|
Genentech
Sublicense. Upon the terms and conditions set forth
in Schedule 10-D, CAT shall have a sublicense under the Genentech
Patent
Rights (the "Genentech Sublicense") for use with the Dyax Antibody
Library
as permitted by the license granted in Clause
11.1.
|
|
|
(e)
|
XOMA
Covenant. Upon the terms and conditions set forth in
Schedule 10-E, CAT shall have the benefit of the covenant not
to ▇▇▇ conferred pursuant to the XOMA License with regard to infringement
of the XOMA Patent Rights or misappropriation of the XOMA Know-How
(the
"XOMA Covenant") solely to the extent reasonably necessary to permit
the
use by CAT of the Dyax Antibody Library as permitted by the license
granted in Clause 11.1; but the benefit of the covenant shall expressly
exclude the use and practice of the XOMA Patent Rights or XOMA
Know-How
for commercial or industrial manufacture or any activities solely
directed
to the creation of such manufacturing
capabilities.
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27
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11.3
|
As
soon as possible following the date of this Agreement Dyax will
transfer
to CAT at its own expense the Dyax Materials and will disclose
the Dyax
Know-How to CAT. Prior to the shipment of the Dyax Materials
Dyax and CAT shall agree on appropriate specifications for the
shipment
and delivery of the Dyax Materials. Dyax shall be responsible
for obtaining all import and export licences and approvals required
in
order to transfer the Dyax Materials and Dyax Know-How to CAT at
its site
on Granta Park, Cambridge, England (the "CAT
Site").
|
|
11.4
|
Within
thirty (30) days after the execution of this Agreement, Dyax shall
transfer the Dyax Antibody Libraries (sufficient for [*****] selections),
Dyax Materials and Dyax Know-How to CAT for use by CAT and its
Affiliates
in accordance with the terms and conditions of this
Agreement. Following the[*****], Dyax shall make
additional transfers of the Dyax Antibody Libraries at least sufficient
for [*****] selections at no additional cost or expense to
CAT.
|
|
11.5
|
In
the event of any loss of the Dyax Antibody Library by CAT, Dyax
will
provide CAT with a new copy of the Dyax Materials as soon as possible
following such loss, provided that (i) CAT shall not be entitled
to
request such a new copy more than once in any one hundred and eighty
(180)
day period, and (ii) CAT shall reimburse Dyax for any reasonable
costs
incurred in connection with the production and delivery of such
Dyax
Materials. On [*****], Dyax shall provide CAT with
all material updates and improvements made or controlled by Dyax
to the
Dyax Antibody Libraries, Dyax Materials and all related Dyax Know-How
("Updates") at no additional cost to CAT and such
Updates shall thereafter be deemed to be included in the license
granted
to CAT under Clause 11.1.
|
|
11.6
|
At
CAT's request, Dyax shall provide on-site training to CAT in the
use of
the Dyax Antibody Libraries and Dyax Materials at mutually acceptable
times and locations. Such training shall be provided by
[*****]. Such training shall be provided at no cost to CAT
other than Dyax's reasonable, out-of-pocket, invoiced and documented
travel, lodging and other similar expenses. After such [*****]
of training, Dyax will provide additional training to CAT at mutually
acceptable times and locations at a cost of [*****] per employee
per day,
plus reimbursement for Dyax's reasonable, out-of-pocket, invoiced
and
documented travel, lodging and other similar
expenses
|
|
11.7
|
CAT
acknowledges that its rights with respect to the Dyax Patent Rights,
Dyax
Antibody Libraries, Dyax Materials or Dyax Know-How are limited
to those
expressly granted in this Clause 11 and Clause 2. Each Party
agrees that, except as expressly set forth in this Agreement, no
other
rights or licenses, express or implied, are granted to any patents,
Patent
Rights, inventions, trademarks, trade secrets or other
intellectual property, or to any materials, information, data or
know-how,
of the other Party. Without in any way limiting the scope of
the foregoing, CAT also acknowledges and agrees
that:
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28
|
|
(a)
|
no
rights are granted to CAT by Dyax to use the Dyax Antibody Libraries,
Dyax
Materials or Dyax Know-How except for the purposes of carrying
out
research and development activities in relation to identifying
Dyax
Licensable Antibodies or potential CAT
Products;
|
|
|
(b)
|
the
use of the Dyax Antibody Libraries, Dyax Materials, or Dyax Know-How
are
solely for internal research and development purposes. CAT
shall not transfer the Dyax Antibody Libraries, Dyax Materials,
or Dyax
Know-How to any Third Party and shall not perform services or enter
co-development lead discovery agreements with or on behalf of a
Third
Party under which any of the Dyax Antibody Libraries, Dyax Materials
or
Dyax Know-How are utilized;
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|
|
(c)
|
Dyax
has previously licensed and will continue to license use of the
Dyax
Antibody Libraries to Third Parties and as such it may be possible
that
Third Parties may generate the same Antibodies as CAT and therefore
have
access and rights to the same, and nothing contained in this Agreement
shall be deemed to prohibit or restrict Dyax from continuing to
supply
Dyax Antibody Libraries to Third Parties, or serve as the basis
for any
claim of liability against Dyax as a result of such
activities;
|
|
|
(d)
|
Dyax
has used and will continue to use the Dyax Antibody Libraries and
Dyax
Patent Rights in connection with Dyax's own internal research and
development activities to discover Antibodies and as such it may
be
possible for Dyax to generate Antibodies or products that are the
same or
similar to Licensed Antibodies or Products developed by
CAT;
|
|
|
(e)
|
the
Dyax Materials that are provided by Dyax to CAT are to be used
for
research and development purposes only in accordance with Section
11.1;
and
|
|
|
(f)
|
Dyax
is and shall remain the owner of the Dyax Antibody Libraries, including
without limitation any improvements to the Dyax Antibody Library
that are
developed by CAT or its Affiliates as a result of exercising the
rights
granted pursuant to this Agreement ("Dyax Antibody Library
Improvements"). CAT shall execute and deliver to Dyax, without
charge, irrevocable assignments of its right, title and interest
in and to
any and all Dyax Antibody Library Improvements and any intellectual
property rights thereto to Dyax and shall take all other actions
as may
reasonably be requested by Dyax to vest in Dyax all right, title
and
interest in such Dyax Antibody Library Improvements and intellectual
property rights. Dyax shall have the sole right to prepare,
file, prosecute, maintain and enforce patent applications and patents
arising therefrom claiming inventions made by Dyax or its employees
or
otherwise relating to the Dyax Antibody Libraries and Dyax Antibody
Library Improvements. CAT shall have a licence to use any Dyax
Antibody Library Improvements on the same terms as set out in Clause
11.1
above and in Clause 12.2 below except that, in the case of the
licence
granted pursuant to Clause 12.2, such licence shall be
[*****].
|
|
11.8
|
CAT
shall indemnify the Dyax Indemnitees against any liability, damage,
loss
or expense (including attorneys fees and expenses of litigation)
incurred
by or imposed upon the Dyax Indemnitees or any one of them in connection
with any claims, suits, actions, demands or judgments by or in
favour of
any Third Party concerning any use by CAT of the Dyax Antibody
Library or
Dyax Materials.
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29
|
12.1
|
Number
of Options: In accordance with this Clause 12 Dyax grants to CAT and
its Affiliates an option to obtain [*****] CAT Product Licences
for CAT
Products.
|
|
12.2
|
If
CAT or its Affiliate wishes to develop and commercialise a CAT
Product to
a particular Target, CAT may at any time [*****], by written notice
to
Dyax ("CAT Target Option Notice") require that Dyax grant
CAT or its Affiliate a CAT Product Licence in relation to such
Target. Provided that CAT has at least one option remaining
from its allocation set out in Clause 12.1 above, Dyax will be
deemed to
have granted to CAT or its Affiliate a non-exclusive, royalty bearing
license, with the right to sublicense under the Dyax Patent Rights
and
Dyax Know-How to research, develop and Exploit CAT Products against
such
Target in the Territory ("CAT Product
Licence").
|
|
12.3
|
CAT
or its Affiliate shall be entitled to sublicense its rights under
any CAT
Product Licence to one or more CAT Sublicensees. Furthermore
each CAT Sublicensee may also sublicense to any Third Party and
so on
provided that in each case any sublicensee executes a written agreement
(a) which requires sublicensee to abide by the terms of the CAT
Product
Licence and which (b) is consistent with the terms of Clause 11
of this
Agreement, this Clause 12 and Clause 13 below. CAT (and where
relevant each CAT Sublicensee) will be liable for any breach of
this
Agreement by a sublicense.
|
|
12.4
|
Commencing
with the first calendar year following the year in which CAT or
its
Affiliate has obtained rights under its first CAT Product Licence,
CAT
will provide to Dyax a brief summary of the status of all outstanding
CAT
Products with respect to which CAT has obtained rights under a
CAT Product
Licence ("CATStatus
Report"). CAT will prepare and provide to Dyax the CAT
Status Report on an annual basis by [*****] of each year, which
will
summarize the status of each CAT Product in the preceding calendar
year.
|
|
12.5
|
Unless
terminated under Clause 12.12, Clause 12.13 or Clause 12.14, each
CAT
Product Licence shall continue, on a country-by-country and CAT
Product-by-CAT Product basis until [*****] years after First Commercial
Sale of such CAT Product, after which period the licence will become
fully
paid up.
|
|
12.6
|
CAT
and each CAT Sublicensee (or its sublicensee) shall indemnify the
Dyax
Indemnitees against any liability, damage, loss or expense (including
attorneys fees and expenses of litigation) incurred by or imposed
upon the
Dyax Indemnitees or any one of them in connection with any claims,
suits,
actions, demands or judgments by or in favour of any Third Party
concerning any manufacture, use or sale of any CAT Product by CAT
or such
CAT Sublicensee (or its
sublicensee).
|
|
12.7
|
Dyax
shall not be liable to CAT or any CAT Sublicensee (or its sublicensee)
in
respect of any liability, loss, damage or expense (including attorneys
fees and expenses of litigation) incurred or suffered by CAT and
any CAT
Sublicensee (or its sublicensee) in connection with the manufacture,
use
or sale of any CAT Products by CAT or such CAT Sublicensee (or
its
sublicensee).
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30
|
12.8
|
No
warranty or representation is given by Dyax that the Dyax Patent
Rights
are, or will be, valid or that the exercise by CAT of the rights
granted
to CAT by Dyax under this Agreement will result in any Dyax Licensable
Antibodies or CAT Products or as a warranty or representation by
Dyax that
the exploitation of the Dyax Patent Rights, Dyax Antibody Libraries,
Dyax
Materials or Dyax Know-How any Licensable Antibodies or CAT Product
will
be free from infringement of patents of third
parties. FURTHERMORE, DYAX DISCLAIMS ANY AND ALL WARRANTIES OF
ANY KIND WITH REGARD TO THE DYAX PATENT RIGHTS, DYAX ANTIBODY LIBRARIES,
DYAX MATERIALS AND DYAX KNOW-HOW, WHETHER EXPRESS OR IMPLIED, INCLUDING,
BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A
PARTICULAR PURPOSE, ANY WARRANTIES ARISING FROM COURSE OF DEALING
OR USAGE
OF TRADE OR THE WARRANTY OF
NONINFRINGEMENT.
|
|
12.9
|
CAT
shall notify Dyax promptly of any proceedings or applications for
revocation of any of the Dyax Patent Rights emanating from a Third
Party
that comes to its notice or if a Third Party takes or threatens
to take
any proceedings for infringement of any patents of that Third Party
by
reason of CAT's use or operation of the Dyax Patent Rights or manufacture,
use or sale of the CAT Products. CAT shall notify
Dyax promptly of any infringement of the Dyax Patent Rights by
a Third Party which may come to its attention during the term of
the CAT
Product Licence, except CAT shall have no obligation to so notify
Dyax
with respect to any infringement by an academic or not-for-profit
entity
which occurs by reason of such entity carrying out research activities
provided such activities are, as far as CAT is aware, not being
carried
out with a view to commercialising a product or otherwise for
profit.
|
|
12.10
|
Dyax
shall have the sole right and responsibility, at its sole discretion
and
cost and with reasonable assistance from CAT, to file, prosecute
and
maintain the Dyax Patent Rights and for the conduct of any lawsuits,
claims or proceedings challenging the validity or enforceability
thereof
including, without limitation, any interference or opposition proceeding
relating thereto in all countries. For the avoidance of doubt,
CAT and CAT Sublicensee (or its sublicensee) will have the right
to
conduct any proceedings relating to a CAT Product including any
proceedings relating to product
liability.
|
|
12.11
|
CAT
and any CAT Sublicensee (or its sublicensee) may assign the benefit
and/or
burden of any CAT Product Licence to any Affiliate or Third Party,
provided that such Affiliate or Third Party undertakes to Dyax
to be bound
by the terms of the CAT Product
Licence.
|
|
12.12
|
Dyax
shall have the right to terminate any CAT Product Licence in the
event CAT
or a CAT Sublicensee (or its sublicensee) directly or indirectly
opposes
or assists any Third Party to oppose the grant of letters patent
or any
patent application within the Dyax Patent Rights, or disputes or
directly
or indirectly assists any Third Party to dispute the validity of
any
patent within the Dyax Patent Rights or any of the claims
thereof.
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31
|
12.13
|
In
the event that either Party commits a material breach of any of
its
obligations with respect to a CAT Product Licence, and such Party
fails to
remedy that breach within [*****] after receiving written notice
thereof
from the other Party, that other Party may immediately terminate
the CAT
Product Licence upon written notice to the breaching
Party.
|
|
12.14
|
Either
Party may terminate a CAT Product Licence in its entirety by giving
notice
in writing to the other Party if any one or more of the following
events
happens:
|
|
|
(a)
|
the
other Party has any distress or execution levied on the major portion
of
its assets (as determined by its balance sheet in accordance with
GAAP)
which is not paid out within [*****] days of its being
levied;
|
|
|
(b)
|
the
other Party calls a meeting for the purpose of passing a resolution
to
wind it up, or such a resolution is passed, or the other Party
presents,
or has presented, a petition for a winding up order, or presents,
or has
presented, a petition to appoint an administrator, or has an
administrative receiver, or receiver, liquidator or other insolvency
practitioner appointed over all or any substantial part of its
business,
undertaking, property or assets;
|
|
|
(c)
|
the
other Party stops or suspends making payments (whether of principal
or
interest) with respect to substantially all of its debts or announces
an
intention to do so or the other Party suspends or ceases to carry
on its
business;
|
|
|
(d)
|
a
secured lender to the other Party holding a security interest over
the
major portion of the tangible assets (as determined by its balance
sheet
in accordance with GAAP) of such other Party takes any steps to
obtain
possession of the property on which it has security or otherwise
to
enforce its security; or
|
|
|
(e)
|
the
other Party suffers or undergoes any procedure analogous to any
of those
specified in Clause 12.14(a) - (d) above or any other procedure
available
in the country in which the other Party is constituted, established
or
domiciled against or to an insolvent debtor or available to the
creditors
of such a debtor.
|
|
13.1
|
CAT
will have no obligation whatsoever to make any payments to Dyax
for the
rights granted to CAT under Clause 2 above including by way of
royalty,
milestone, payment of maintenance
fee.
|
|
13.2
|
Without
prejudice to Clause 13.1 above, Dyax agrees that CAT will have
no
obligations whatsoever to make any payments (whether by way of
royalty,
milestone or otherwise) to Dyax for any reason in relation to the
sums CAT
may have received or will receive in respect of the D2E7 product
developed
by CAT under the ▇▇▇▇▇▇ Agreement or any agreement which replaces
or
amends the ▇▇▇▇▇▇ Agreement in the future. Dyax, on behalf of
itself and its assigns and successors (each a "Dyax
Entity"), hereby releases and forever discharges CAT, its
Affiliates, assignees, successors and licensees and predecessors
and any
directors and officers of the foregoing (each a "CAT
Entity") from any and all actions, courses of action, claims,
demands, damages and expenses and any other thing in law, equity
or
otherwise whether now known or unknown or which have ever existed,
now
exist or which may exist in the future which any Dyax Entity may
have
against any CAT Entity arising out of or relating to any agreements,
events or conduct relating to the D2E7 product developed by CAT
under the
▇▇▇▇▇▇ Agreement.
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32
|
13.3
|
CAT
will pay to Dyax a royalty of [*****] on Net Sales of CAT Products
by CAT,
its Affiliates or a CAT Sublicensee (or its sublicensees). All
royalties due to Dyax under this Clause 13.3 shall be payable on
a country
by country basis for [*****] years from the date of First Commercial
Sale
of such CAT Product.
|
|
13.4
|
CAT
shall make the payments due to Dyax under this Clause 13 in United
States
dollars (if CAT in turn receives payment in dollars) or in pounds
sterling
(if CAT in turn receives payment in pound sterling), or Euros (if
CAT in
turn receives payment in Euros). Where CAT receives payment in
a currency other than United States dollars, pounds sterling or
Euros, CAT
will convert the relevant sum into pounds sterling (or Euros if
Euros have
replaced pounds sterling at the time of payment). CAT will use
the conversion rate reported in the Financial Times [*****] Business
Days
before the day on which CAT pays Dyax. Such payment will be
made without deduction of exchange, collection or other
charges. All payments will be made at Quarterly
intervals. Within [*****] days of the end of each Quarter after
the First Commercial Sale of each CAT Product, in any country,
CAT shall
prepare a statement which shall show on a country-by-country basis
for the
previous Quarter Net Sales of each CAT Product, by CAT or its Affiliates
and all monies due to Dyax based on such Net Sales. That
statement shall include details of Net Sales broken down to show
the
country of the sales and the total Net Sales by CAT or its Affiliates
in
such country and shall be submitted to Dyax within such [*****]
day period
together with remittance of the monies due. With respect to Net
Sales of a Product, by a CAT Sublicensee (or its sublicensee) CAT
shall
prepare a statement which will include the same information and
remit that
statement and any monies due within the same
period.
|
|
13.5
|
All
payments shall be made free and clear of and without deduction
or
deferment in respect of any disputes or claims whatsoever and/or
as far as
is legally possible in respect of any taxes imposed by or under
the
authority of any government or public authority. Any tax (other
than VAT) which CAT is required to pay or withhold with respect
of the
payments to be made to Dyax hereunder shall be deducted from the
amount
otherwise due provided that, in regard to any such deduction, CAT
shall
give Dyax such assistance, which shall include the provision of
such
documentation as may be required by any revenue authority and other
revenue services, as may reasonably be necessary to enable Dyax
to claim
exemption therefrom or obtain a repayment thereof or a reduction
thereof
and shall upon request provide such additional documentation from
time to
time as is needed to confirm the payment of tax. If by law,
regulation or fiscal policy of a particular country, a remittance
of
royalties in the currency stipulated in Clause 13.5 above, as the
case may
be, is restricted or forbidden, notice thereof will be promptly
given to
Dyax, and payment of the royalty shall be made by the deposit thereof
in
local currency to the credit of Dyax in a recognized banking institution
designated by Dyax or its Affiliates. When in any country a law
or regulation that prohibits both the transmittal and deposit of
such
payments ceases to be in effect, all royalties that CAT would have
been
under obligation to transmit or deposit but for the prohibition,
shall
forthwith be deposited or transmitted promptly to the extent
allowable.
|
33
|
13.6
|
CAT
shall keep and shall procure that its Affiliates and CAT Sublicensees
keep
true and accurate records and books of account containing all data
necessary for the calculation of the amounts payable by it to Dyax
pursuant to this Agreement. Those records and books of account
shall be kept for [*****] years following the end of the Year to
which
they relate. Upon Dyax's written request, a firm of accountants
appointed by agreement between the Parties or, failing such agreement
within [*****] Business Days of the initiation of discussions between
them
on this point Dyax shall have the right to cause an international
firm of
independent certified public accountants that has not performed
auditing
or other services for either Party or their Affiliates (or, if
applicable,
any CAT Sublicensee with rights to the CAT Product in question)
acceptable
to CAT or the CAT Sublicensee such acceptance not to be unreasonably
withheld to inspect such records and books of account. In
particular such firm:
|
|
13.6.1
|
shall
be given access to and shall be permitted to examine and copy such
books
and records of CAT and its Affiliates and CAT Sublicensees upon
[*****]
Business Days notice having been given by Dyax and at all reasonable
times
on Business Days for the purpose of certifying that the Net Sales
or other
relevant sums calculated by CAT and its Affiliates and CAT Sublicensees
during any Year were reasonably calculated, true and accurate or,
if this
is not their opinion, certify the Net Sales figure or other relevant
sums
for such period which in their judgment is true and
correct;
|
|
13.6.2
|
prior
to any such examination taking place, such firm of accountants
shall
undertake to CAT that they shall keep all information and data
contained
in such books and records, strictly confidential and shall not
disclose
such information or copies of such books and records to any third
person
including Dyax, but shall only use the same for the purpose of
calculations which they need to perform in order to issue the certificate
to which this Clause envisages;
|
|
13.6.3
|
any
such access examination and certification shall occur no more than
once
per Year and will not go back over records more than [*****] years
old;
|
|
13.6.4
|
CAT
and its Affiliates and CAT Sublicensee shall make available personnel
to
answer queries on all books and records required for the purpose
of that
certification; and
|
|
13.6.5
|
the
cost of the accountant shall be the responsibility of CAT if the
certification shows it to have underpaid monies to Dyax by more
than
[*****] and the responsibility of Dyax
otherwise.
|
|
13.7
|
All
payments due to Dyax under the terms of this Agreement are expressed
to be
exclusive of value added tax (VAT) howsoever arising. If Dyax
is required to charge VAT on any such payment, Dyax will notify
CAT. CAT will then use all commercially reasonable endeavours
to obtain a VAT registration as soon as reasonably possible in
order to
allow it to reclaim any VAT so chargeable. If CAT does obtain a
VAT registration then VAT will be added to any relevant payment
at the
applicable rate. If having used all commercially reasonable
endeavours CAT is not able to reclaim the VAT (in whole or in part)
the
parties agree that the amount of any VAT payable will be shared
between
them equally.
|
34
|
13.8
|
All
payments made to Dyax under this Agreement shall be made to the
bank
account of Dyax as notified by Dyax to CAT from time to
time.
|
|
13.9
|
If
CAT fails to make any payment to Dyax hereunder on the due date
for
payment, without prejudice to any other right or remedy available
to Dyax
it shall be entitled to charge CAT interest (both before and
after judgment) of the amount unpaid at the annual rate of LIBOR
(London
Interbank Offering Rate) plus [*****] calculated on a daily basis
until
payment in full is made without prejudice to Dyax's right to receive
payment on the due date.
|
|
14.1
|
Each
Party represents, warrants, undertakes and agrees for the benefit
of the
other Party that:
|
|
14.1.1
|
it
has full power to enter into and perform this
Agreement;
|
|
14.1.2
|
so
far as it is aware the execution and delivery of this Agreement
and the
performance of and compliance with its terms and provisions will
not:
|
|
|
(a)
|
conflict
with or result in a breach of, or constitute a default under, any
agreement or instrument to which it is a party or by which it is
bound or
with its memorandum and articles of
association;
|
|
|
(b)
|
conflict
with or result in a breach of any law, regulation or order of any
court;
|
|
14.2
|
CAT
represents, warrants and undertakes for the benefit of Dyax as
at 3
January 2003:
|
|
14.2.1
|
CAT
has provided to Dyax a complete and accurate description of CAT's
Gatekeeping Procedure;
|
|
14.2.2
|
CAT
will keep the agreement between it and the Medical Research Council
dated
7 January 1997 in force;
|
|
14.2.3
|
the
patents and applications listed in Schedule 1 are all the Patent
Rights relating to the technology of Antibody phage display owned
or
controlled by CAT (including Patent Rights sublicensed by CAT from
the
Medical Research Council), except as specifically excluded in this
Agreement. If CAT has inadvertently excluded any such Patent
Right from Schedule 1, such omission shall not be considered a
breach of this representation and warranty but rather any missing
Patent
Right shall be deemed to be so included in Schedule
1;
|
|
14.3
|
Dyax
represents, warrants and undertakes for the benefit of CAT
that:
|
35
|
14.3.1
|
as
at 31 December 1997 it possessed the exclusive right, title and
interest
in and to the Dyax Patent Rights and that it had the full legal
right and
power to enter into the obligations and grant the rights and licences
set
forth in this Agreement;
|
|
14.3.2
|
as
at the date of this Agreement the patents and applications listed
in
Schedule 5 are all the Patent Rights relating to the technology
of
creating and using the Dyax Antibody Library owned or controlled
by Dyax,
except as specifically excluded in this Agreement. If Dyax has
inadvertently excluded any such Patent Right from Schedule 5, such
omission shall not be considered a breach of this representation
and
warranty but rather any missing Patent Right shall be deemed to
be so
included in Schedule 5; and
|
|
14.3.3
|
as
at the date of this Agreement neither Dyax nor any Dyax Affiliate
has
received any written notice or other communication from a Third
Party
alleging that the practice of the Dyax Patent Rights infringes
the rights
of such Third Party.
|
|
14.4
|
Nothing
in this Agreement shall be construed
as:
|
|
14.4.1
|
a
warranty or representation by Dyax or CAT as to the validity or
scope of
any patent included within any Patent Rights licensed pursuant
to this
Agreement.
|
|
14.4.2
|
a
warranty or representation that the exploitation of any Patent
Rights or
the manufacture, use or sale of a Licensed Intermediate or a Licensed
Products or a Product, or Other Product is or will be free from
infringement of patents of Third
Parties;
|
|
14.4.3
|
an
obligation of either Party to bring or prosecute actions or suits
against
Third Parties for infringement;
|
|
14.4.4
|
an
obligation of CAT or Dyax to maintain any patent or to continue
to
prosecute any patent application included within the Patent Rights
licensed pursuant to this Agreement in any
country;
|
|
14.4.5
|
creating
any agency, partnership, joint venture or similar relationship
between CAT
and Dyax ; or
|
|
14.4.6
|
conferring
by implication, estoppel or otherwise any license, immunity or
right under
any patent of Dyax or CAT other than those specified in the Dyax
Patent
Rights or the CAT Antibody Phage Display Patent
Rights.
|
|
15.1
|
The
options granted by CAT in Clause 3 will continue until (a) 31 December
2017; or (b) the termination of this Agreement in accordance with
Clause
15.3 below.
|
|
15.2
|
The
term of this Agreement shall commence upon the Restatement Date
save for
those provisions which are expressed to have an effect from the
Commencement Date (in which case the relevant term will be deemed
to have
commenced as of the Commencement Date and be subject to the remaining
terms of this Agreement) and shall terminate upon (a) the last-to-expire
of claims of an issued and unexpired patent within the CAT Antibody
Phage
Display Patents or the Dyax Patent Rights (as the case may be)
(which has
not been held permanently revoked, unenforceable or invalid by
a decision
of a court or other governmental agency of competent jurisdiction
unappealed within the time allowed for appeal, and which has not
been
admitted to be invalid or unenforceable through reissue or disclaimer
or
otherwise) or (b) the date upon which no payments are due to CAT
under
Clause 8 of this Agreement and no payments are due to Dyax under
Clause 13
of this Agreement, whichever event occurs
last.
|
36
|
15.3
|
Either
Party may terminate this Agreement in its entirety by giving notice
in
writing to the other Party if any one or more of the following
events
happens:
|
|
|
(a)
|
the
other Party commits a material breach of any of its obligations
under this
Agreement which is incapable of
remedy;
|
|
|
(b)
|
the
other Party fails to remedy, where it is capable of remedy, or
persists in
any breach of any of its obligations under this Agreement after
having
been required in writing to remedy or desist from such breach within
a
period of ninety (90) days;
|
|
|
(c)
|
the
other Party has any distress or execution levied on the major portion
of
its assets (as determined by its balance sheet in accordance with
GAAP)
which is not paid out within thirty (30) days of its being
levied;
|
|
|
(d)
|
the
other Party calls a meeting for the purpose of passing a resolution
to
wind it up, or such a resolution is passed, or the other Party
presents,
or has presented, a petition for a winding up order, or presents,
or has
presented, a petition to appoint an administrator, or has an
administrative receiver, or receiver, liquidator or other insolvency
practitioner appointed over all or any substantial part of its
business,
undertaking, property or assets;
|
|
|
(e)
|
the
other Party stops or suspends making payments (whether of principal
or
interest) with respect to substantially all of its debts or announces
an
intention to do so or the other Party suspends or ceases to carry
on its
business;
|
|
|
(f)
|
a
secured lender to the other Party holding a security interest over
the
major portion of the tangible assets (as determined by its balance
sheet
in accordance with GAAP) of such other Party takes any steps to
obtain
possession of the property on which it has security or otherwise
to
enforce its security;
|
|
|
(g)
|
the
other Party suffers or undergoes any procedure analogous to any
of those
specified in Clause 15.3(c) - (f) above or any other procedure
available
in the country in which the other Party is constituted, established
or
domiciled against or to an insolvent debtor or available to the
creditors
of such a debtor;
|
37
|
15.4
|
Upon
termination of this Agreement for any reason
whatsoever:
|
|
|
(a)
|
the
relationship of the Parties hereunder shall cease save as (and
to the
extent) expressly provided for in this Clause
15.4;
|
|
|
(b)
|
any
unexercised options for Dyax Product Licences granted to Dyax under
this
Agreement shall terminate;
|
|
|
(c)
|
any
unexercised options for CAT Product Licences granted to CAT under
this
Agreement shall terminate;
|
|
|
(d)
|
any
Dyax Product Licence granted to Dyax before the date of termination
shall
continue and the Parties will continue to be bound by the terms
of this
Agreement in relation to any such Dyax Product
Licences;
|
|
|
(e)
|
any
CAT Product Licence granted to CAT before the date of termination
shall
continue and the Parties will continue to be bound by the terms
of this
Agreement in relation to any such CAT Product
Licences;
|
|
|
(f)
|
the
licence granted to Dyax for Other Purposes shall continue with
respect to
any Other Products commercialised prior to the date of termination
of this
Agreement and the Parties will continue to be bound by the terms
of this
Agreement in relation to any such Other
Product;
|
|
|
(g)
|
any
sublicences granted by Dyax in accordance with the terms of this
Agreement
will continue in force provided that such sublicensees are not in breach
of the relevant sublicence and that each sublicensee agrees to
enter into
a direct agreement with CAT upon the terms of this
Agreement;
|
|
|
(h)
|
the
Parties acknowledge and agree that Dyax Sublicensees, as well as
sublicensees of the foregoing to the extent permitted under this
Agreement, each derive independent and significant value from the
agreements set forth herein and may rely thereon and to that extent
only
shall each have the right to enforce the provisions of Clause 15.4
(g) of
this Agreement and be a third party beneficiary for that purpose
only;
|
|
|
(i)
|
Dyax
shall immediately return or procure to be returned to CAT at such
place as
it directs and at the expense of Dyax (or if CAT so requires by
notice to
Dyax in writing, destroy) all CAT Know-How together with all copies
of
such CAT Know-How in its possession or under its
control;
|
|
|
(j)
|
CAT
shall immediately return or procure to be returned to Dyax at such
place
as it directs and at the expense of CAT (or if Dyax so requires
by notice
to CAT in writing, destroy) all Dyax Antibody Libraries, Dyax Materials
and Dyax Know-How together with all copies, where applicable, in
its
possession or under its control;
|
38
|
|
(k)
|
the
rights of any Commercial Party shall not be affected by the termination
or
expiration of this Agreement provided that the Commercial Party
continues
to perform the obligations of CAT pursuant to Clause 2. CAT's
rights and obligations, with respect to Licensed Products developed
using
the Dyax Base Phage Display Patent Rights, or developed as a result
of
Licensed Intermediates, during the term of this Agreement will
survive
termination or expiration of this
Agreement;
|
|
|
(l)
|
any
sublicences granted by CAT with respect to the rights granted to
CAT under
Clause 2 of this Agreement will continue in force provided that
such
sublicensees are not in breach of the relevant sublicence and that
each
sublicensee agrees to enter into a direct agreement with Dyax upon
the
terms of this Agreement;
|
|
|
(m)
|
the
Parties acknowledge and agree that CAT sublicensees each derive
independent and significant value from the agreements set forth
herein and
may rely thereon and to that extent only shall each have the right
to
enforce the provisions of Clause 15.4 (l) of this Agreement and
be a third
party beneficiary for that purpose
only;
|
|
16.1
|
With
respect to any confidential information received from the other
Party
("Confidential Information"), each Party undertakes and
agrees to:
|
|
16.1.1
|
only
use the Confidential Information for the purposes envisaged under
this
Agreement and not to use the same for any other purpose
whatsoever;
|
|
16.1.2
|
ensure
that only those of its officers and employees who are directly
concerned
with the carrying of this Agreement have access to the Confidential
Information on a strictly "need to know" basis and are informed
of the
secret and confidential nature of
it;
|
|
16.1.3
|
keep
the Confidential Information secret, confidential, safe and secure
and
shall not directly or indirectly disclose or permit to be disclosed
the
same to any Third Party, including any consultants or other advisors,
without the prior written consent of the disclosing party except
to the
extent disclosure is necessary in connection with its use as envisaged
under this Agreement;
|
|
16.1.4
|
ensure
that the Confidential Information will not be covered by any lien
or other
encumbrance in any way; and
|
|
16.1.5
|
not
copy, reproduce or otherwise replicate for any purpose or in any
manner
whatsoever any documents containing the Confidential Information
except to
the extent necessary in connection with its use as envisaged under
this
Agreement.
|
39
|
16.2
|
The
obligations referred to in Clause 16.1 above shall not extend to
any
Confidential Information which:
|
|
16.2.1
|
is
or becomes generally available to the public otherwise than be
reason of
breach by a recipient Party of the provision of Clause
16.1;
|
|
16.2.2
|
is
known to the recipient Party and is at its free disposal (having
been
generated independently by the recipient Party or a Third Party
in
circumstances where it has not been derived directly or indirectly
from
the disclosing Party's Confidential Information prior to its receipt
from
the disclosing Party), provided that evidence of such knowledge
is
furnished by the recipient Party to the disclosing Party within
twenty
eight (28) days of recipient of that Confidential
Information;
|
|
16.2.3
|
is
subsequently disclosed to the recipient Party without obligations
of
confidence by a Third Party owing no such obligations to the disclosing
Party in respect of that Confidential
Information;
|
|
16.2.4
|
is
required by law to be disclosed (including as part of any regulatory
submission or approval process) and then only when prompt written
notice
of this requirement has been given to the disclosing Party so that
it may,
if so advised, seek appropriate relief to prevent such disclosure,
provided always that in such circumstances such disclosure shall
be only
to the extent so required and shall be subject to prior consultation
with
the disclosing Party with a view to agreeing on the timing and
content of
such disclosure.
|
|
16.3
|
No
public announcement or other disclosures to Third Parties concerning
the
terms of this Agreement shall be made, whether directly or indirectly,
by
any Party to this Agreement (except confidential disclosures to
professional advisors) without first obtaining the approval of
the other
Party and agreement upon the nature and text of such announcement
or
disclosure provided that:
|
|
16.3.1
|
a
Party may disclose those terms which it is required by regulation
or law
to disclose, provided that it takes advantage of all provisions
to keep
confidential as many terms of this Agreement as possible;
and
|
|
16.3.2
|
the
Party desiring to make any such public announcement or other disclosure
shall inform the other Party of the proposed announcement or disclosure
in
reasonably sufficient time prior to public release, and shall provide
the
other Party with a written copy thereof, in order to allow such
Party to
comment upon such announcement or disclosure in reasonably sufficient
time
prior to public release, and shall provide the other Party with
a written
copy thereof, in order to allow such Party to comment upon such
announcement or disclosure. Each Party agrees that it shall
cooperate fully with the other with respect to all disclosures
regarding
this Agreement to the US Securities Exchange Commission, the UK
Stock
Exchange and any other comparable body including requests for confidential
information or proprietary information of either party included
in any
such disclosure. The Parties agree that each shall be entitled
from time to time to include the name of other within a list of
licensees
under the respective Patent Rights in a public
announcement.
|
40
|
17.1
|
This
Agreement shall be governed by and construed in accordance with
the laws
of the Commonwealth of
Massachusetts.
|
|
17.2
|
Any
dispute, controversy or claim arising under, out of or relating
to this
agreement and any subsequent amendments of this contract, including,
without limitation, its formation, validity, binding effect,
interpretation, performance, breach or termination, as well as
non-contractual claims, shall be referred to and finally determined
by
arbitration in accordance with the World Intellectual Property
Organization Arbitration Rules. The arbitral tribunal shall consist
of
three arbitrators. The place of arbitration shall be Boston, Massachusetts
if the arbitration is initiated by CAT, and it shall be London,
England if
the arbitration is initiated by Dyax. The language to be used
in the arbitral proceedings shall be English. The dispute,
controversy or claim shall be decided in accordance with the law
of the
Commonwealth of Massachusetts,
U.S.A.
|
18. Assignment
|
18.1
|
Subject
to Clause 6.9, this Agreement may not be assigned by either Party
without
the prior written consent of the other Party, except that either
Party may
assign the Agreement to any of its Affiliates or either Party may
assign
this Agreement to a successor in connection with the merger, consolidation
or sale of all or substantially all of its assets or the portion
of its
business pertaining to the subject matter of this Agreement with
prompt
notice to the other Party of such assignment. This Agreement
shall inure for the benefit of and be binding on the Parties and
their
respective lawful successors and
assignees.
|
19. Miscellaneous
|
19.1
|
Acknowledgement
Regarding Royalties. Dyax and CAT each acknowledge and
agree that the amount of royalties due from one Party to the other
under
this Agreement and the duration of such royalty payments have been
chosen
for the convenience of the Parties as payment for use of the other
Party's
proprietary technology to identify, generate, develop, produce
or optimize
Antibodies Products and CAT Products including
in the case of patented technology, for use thereof during the
life of
such patents.
|
|
19.2
|
Notices
- All notices, requests, demands and other communications required
or
permitted to be given pursuant to this Agreement shall be in writing
and
shall be deemed to have been duly given upon the date of receipt
if
delivered by hand, recognized international overnight courier,
confirmed
facsimile transmission, or registered or certified mail, return
receipt
requested, postage prepaid to the following addresses or facsimile
numbers:
|
41
|
If
to Dyax:
|
If
to CAT:
|
|
Cambridge
Antibody Technology Limited
|
|
|
▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
|
▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇,
|
|
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇ ▇▇▇
|
|
▇▇▇
|
▇▇
|
|
Attention: Corporate
Counsel
|
Attention: Company
Secretary
|
|
Facsimile:
(▇▇▇) ▇▇▇ ▇▇▇▇
|
Facsimile: 01223
471472
|
|
19.3
|
Compliance
with Law - Nothing in this Agreement shall be construed so as to
require the commission of any act contrary to law, and wherever
there is
any conflict between any provision of this Agreement and any statute,
law,
ordinance or treaty, the latter shall prevail, but in such event
the
affected provisions of the Agreement shall be conformed and limited
only
to the extent necessary to bring it within the applicable legal
requirements.
|
|
19.4
|
Amendment
and Waiver - This Agreement may be amended, supplemented, or otherwise
modified only by means of a written instrument signed by both
parties. Any waiver of any rights or failure to act in a
specific instance shall relate only to such instance and shall
not be
construed as an agreement to waive any rights or fail to act in
any other
instance, whether or not similar.
|
|
19.5
|
Severability
- In the event that any provision of this Agreement shall, for
any reason,
be held to be invalid or unenforceable in any respect, such invalidity
or
unenforceability shall not affect any other provision hereof, and
the
parties shall negotiate in good faith to modify the Agreement to
preserve
(to the extent possible) their original
intent.
|
|
19.6
|
Entire
Agreement - This Agreement, together with (i) [*****], (ii) [*****]
and (iii) [*****], constitutes the entire agreement between the
parties
with respect to the subject matter hereof and supersedes all prior
agreements or understandings between the parties relating to the
subject
matter hereof. [*****].
|
42
IN
WITNESS OF THE ABOVE the Parties have signed this Agreement on the date
written at the head of this Agreement.
|
SIGNED
by
|
|
|
| ▇▇▇▇▇▇ ▇▇▇▇ |
)
|
|
| General Counsel |
)
|
/s/
▇▇▇▇▇▇
▇▇▇▇
|
|
for
and on behalf of
|
)
|
Authorised
Signatory
|
|
CAMBRIDGE
ANTIBODY
|
)
|
|
|
TECHNOLOGY
LIMITED
|
)
|
|
|
SIGNED
by
|
)
|
|
|
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇
General
Counsel and
Executive
Vice President of Administration
|
)
)
)
|
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇ |
|
for
and on behalf of
|
)
|
Authorised
Signatory
|
| ) |
|
|
|
|
)
|
|
|
)
|
||
43
Schedule
1
|
Family
1 (includes PCT/GB89/01344)
|
|
|
Title
|
|
|
AU
634186 B2
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
CA
2002868 C
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production, and use of said ligands and receptors
|
|
DK
175392 B1
|
Enkelt-domaene-ligander,
receptorer omfattende disse lignader, fremgangsmaader til fremstilling
af
dem og anvendelse af disse ligander og receptorer
(Danish)
|
|
EP
368684 B2
|
Cloning
immunoglobulin variable domain sequences
|
|
GB
8826444 A0
|
Cloning
immunoglobulin variable domains for expression by
polymerase
|
|
GB
8906034 A0
|
Recombinant
DNA method
|
|
GB
8911047 A0
|
Antibody
binding
|
|
GB
8912652 A0
|
Antibody
binding
|
|
GB
8913900 A0
|
Antibody
binding
|
|
GB
8918543 A0
|
Antibody
binding
|
|
GB
899217 A0
|
Antibody
binding
|
|
JP
2919890 B2
|
|
|
JP
3502801 T2
|
|
|
KR
184860 B1
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
US
6248516
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
US
6545142
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
US
20030114659
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
US
20030130496
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
US
20040110941
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production and use of said ligands and receptors
|
|
WO
9005144
|
Single
domain ligands, receptors comprising said ligands, methods for
their
production, and use of said ligands and
receptors
|
Schedule
1
- Page 1
|
Family
2 (includes PCT/US90/02890, PCT/US90/02835,
PCT/US90/02836)
|
|
|
Patent
or Publication No.
|
Title
|
|
AU
643948 B2
|
A
new method for tapping the immunological repertoire
|
|
AU
651065 B2
|
Method
for isolating receptors having a preselected
specificity
|
|
AU
652539 B2
|
Co-expression
of heteromeric receptors
|
|
CA
2016841 C
|
A
method for producing polymers having a preselected
activity
|
|
EP
425661 B1
|
A
new method for tapping the immunological repertoire
|
|
EP
472638 B1
|
Method
for isolating receptors having a preselected
specificity
|
|
EP
478627 A1 (wd)
|
Co-expression
of heteromeric receptors
|
|
EP
1026239 A2/A3
|
A
new method for tapping the immunological repertoire
|
|
GR
1002149 B
|
Method
for producing polymers having a preselected activity
|
|
GR
1002158 B
|
Method
for tapping the immunological repertoire
|
|
JP
3321159 B2
|
|
|
JP
4500607 T2
|
|
|
JP
4506600 T2
|
|
|
JP
5501348 T2
|
|
|
PT
94065 B
|
Processo
de producao de um acido nucleico conservado e de um receptor
codificado
pelo referido acido
|
|
PT
94066 B
|
Processo
para a producao de vectores de and de cadeia dupla e de um sistema
de
clonacao compreendendo os referidos vectores
|
|
US
6291158
|
Method
for tapping the immunological repertoire
|
|
US
6291159
|
Method
for producing polymers having a preselected activity
|
|
US
6291160
|
Method
for producing polymers having a preselected activity
|
|
US
6291161
|
Method
for tapping the immunological repertoire
|
|
US
6680192
|
Method
for producing polymers having a preselected activity
|
|
US
6969586
|
Method
for tapping the immunological repertoire
|
|
US
7189841
|
Method
for tapping the immunological repertoire
|
|
US
20060019260
|
Method
for tapping the immunological repertoire
|
|
WO
9014424
|
Method
for isolating receptors having a preselected
specificity
|
|
WO
9014430
|
A
new method for tapping the immunological repertoire
|
|
WO
9014443
|
Co-expression
of heteromeric receptors
|
Schedule
1
- Page 2
|
Family
3 (includes PCT/GB92/00883, PCT/GB91/01134, PCT/GB92/01755,
PCT/GB92/02240, PCT/GB93/00605)
|
|
|
Patent
or Publication No.
|
Title
|
|
AU
664155 B2
|
Methods
for producing members of specific binding pairs
|
|
AU
665025 B2
|
Production
of chimeric antibodies - a combinatorial approach
|
|
AU
665190 B2
|
Methods
for producing members of specific binding pairs
|
|
AU
665221 B2
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
AU
673515 B2
|
Methods
for producing members of specific binding pairs
|
|
AU
703319 B2
|
Specific
binding members for human carcinoembryonic antigen, materials
and
methods
|
|
CA
2086936 C
|
Method
for producing members of specific binding pairs
|
|
CA
2109602 C
|
Methods
for producing members of specific binding pairs
|
|
CA
2119930 C
|
Production
of chimeric antibodies - a combinatorial approach
|
|
EP
585287 B1
|
Methods
for producing members of specific binding pairs
|
|
EP
589877 B2
|
Methods
for producing members of specific binding pairs
|
|
EP
605522 B1
|
Production
of chimeric antibodies - a combinatorial approach
|
|
EP
616640 B1
|
Production
of anti-self antibodies from antibody seqment repertoires and
displayed on
phage
|
|
EP
656941 B1
|
Methods
for producing members of specific binding pairs
|
|
EP
774511 B1
|
Phagemid-based
method of producing filamentous bacteriophage particles displaying
antibody molecules and the corresponding bacteriophage
paricles
|
|
EP
844306 B1
|
Methods
of producing members of specific binding pairs
|
|
EP
865492 B1
|
Specific
binding members for human carcinoembryonic antigen, materials
and
methods
|
|
EP
1433846 B1
|
Phagemid-based
method of producing filamentous bacteriophage particles displaying
antibody molecules and the corresponding bacteriophage
paricles
|
Schedule
1
- Page 3
|
EP
1024191 A2/A3
|
Production
of chimeric antibodies from antibody segment repertoires and
displayed on
phage
|
|
EP
1754787 A2
|
Methods
for producing members of specific binding pairs
|
|
GB
9015198 A0
|
Binding
substance
|
|
GB
9022845 A0
|
Antibodies
|
|
GB
9024503 A0
|
Binding
substances
|
|
GB
9104744 A0
|
Binding
substances
|
|
GB
9110549 A0
|
Binding
substances
|
|
GB
9120252 A0
|
Improvement
binding substances
|
|
GB
9120377 A0
|
Improved
binding substances
|
|
GB
9125579 A0
|
Binding
molecules 1
|
|
GB
9125582 A0
|
Binding
molecules 2
|
|
GB
9206318 A0
|
Binding
substances
|
|
GB
9206372 A0
|
Binding
substances
|
|
GB
9525004 A0
|
Specific
binding members, materials and methods
|
|
GB
9610824 A0
|
Specific
binding members, materials and methods
|
|
GB
9621295 A0
|
Specific
binding members, materials and methods
|
|
JP
3176917 B2
|
|
|
JP
3507073 B2
|
|
|
JP
3540315 B2
|
|
|
JP
5508076 T2
|
|
|
JP
6508511 T2
|
|
|
JP
6510671 T2
|
|
|
JP
7502167 T2
|
|
|
JP
7505055 T2
|
|
|
JP
2000504204 T2
|
|
|
KR
222326 B1
|
Method
for producing members of specific binding pairs
|
|
US
5565332
|
Production
of chimeric antibodies - a combinatorial approach
|
|
US
5733743
|
Methods
for producing members of specific binding
pairs
|
Schedule
1
- Page 4
|
US
5858657
|
Methods
for producing members of specific binding pairs
|
|
US
5871907
|
Methods
for producing members of specific binding pairs
|
|
US
5872215
|
Specific
binding members, materials and methods
|
|
US
5885793
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
5962255
|
Methods
for producing recombinant vectors
|
|
US
5969108
|
Methods
for producing members of specific binding pairs
|
|
US
6140471
|
Methods
for producing members of specific binding pairs
|
|
US
6172197
|
Methods
for producing members of specific binding pairs
|
|
US
6225447
|
Methods
for producing members of specific binding pairs
|
|
US
6291650
|
Methods
for producing members of specific binding pairs
|
|
US
6492160
|
Methods
for producing members of specific binding pairs
|
|
US
6521404
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
6544731
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
6555313
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
6582915
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
6593081
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
6806079
|
Methods
for producing members of specific binding pairs
|
|
US
6916605
|
Methods
for producing members of specific binding pairs
|
|
US
7063943
|
Methods
for producing members of specific binding pairs
|
|
US
20030190674
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
US
20040157214
|
Methods
for producing members of specific binding pairs
|
|
US
20040157215
|
Methods
for producing members of specific binding pairs
|
|
WO
9201047
|
Methods
for producing members of specific binding pairs
|
|
WO
9220791
|
Methods
for producing members of specific binding pairs
|
|
WO
9306213
|
Production
of chimeric antibodies - a combinatorial approach
|
|
WO
9311236
|
Production
of anti-self antibodies from antibody segment repertoires and
displayed on
phage
|
|
WO
9319172
|
Methods
for producing members of specific binding pairs
|
|
WO
9720932
|
Specific
binding members for human carcinoembryonic antigen, materials
and
methods
|
Schedule
1
- Page 5
|
Family
4 (includes PCT/GB92/01483)
|
|
|
Patent
or Publication No.
|
Title
|
|
AU
665365 B2
|
Treatment
of cell populations
|
|
EP
597960 B1
|
Treatment
of cell populations
|
|
GB
9117352 A0
|
Recombinant
DNA method
|
|
GB
9212419 A0
|
Recombinant
DNA method
|
|
JP
6509473 T2
|
|
|
US
5830663
|
In
situ recombinant PCR within single cells
|
|
WO
9303151
|
Treatment
of cell populations
|
|
Family
5 (includes PCT/GB94/01422)
|
|
|
Title
|
|
|
AU
691817 B2
|
SBP
members with a chemical moiety covalently bound within the binding
site;
production and selection thereof
|
|
EP
706569 B1
|
SBP
members with a chemical moiety covalently bound within the binding
site;
production and selection thereof
|
|
GB
9313509 A0
|
Chemisynthetic
libraries
|
|
JP
9500016 T2
|
|
|
US
6017732
|
Bacteriophage
library displaying immunoglobulin repertoires with a chemical
moiety
covalently bound within the binding site: production and selection
thereof
|
|
WO
9501438
|
SBP
members with a chemical moiety covalently bound within the binding
site;
production and selection thereof
|
Schedule
1
- Page 6
|
Family
6 (includes PCT/GB94/02662)
|
|
|
Title
|
|
|
AU
674568 B2
|
Improved
method for the refolding of proteins
|
|
AU
680685 B2
|
Retargeting
antibodies
|
|
AU
690171 B2
|
Recombinant
binding proteins and peptides
|
|
AU
690528 B2
|
Multivalent
and multispecific binding proteins, their manufacture and
use
|
|
CA
2155335 C
|
Improved
method for the refolding of proteins
|
|
EP
672142 B1
|
Multivalent
and multispecific binding proteins, their manufacture and
use
|
|
EP
686162 B1
|
Improved
method for the refolding of proteins
|
|
EP
720624 B1
|
Retargeting
antibodies
|
|
EP
731842 A1
|
Recombinant
binding proteins and peptides
|
|
FI
113272 B1
|
Parannettu
proteiinien laskostamismenetelma forbattrat forfarande for veckning
av
proteiner (Swedish)
|
|
GB
9225453 A0
|
Binding
proteins
|
|
GB
9300816 A0
|
Improvements
in or relating to binding proteins
|
|
GB
9319969 A0
|
Binding
proteins IV
|
|
GB
9412147 A0
|
Recombinant
binding proteins and peptides
|
|
GB
9412166 A0
|
Retargeting
antibodies
|
|
JP
3695467 B2
|
|
|
JP
3720353 B2
|
|
|
JP
8504100 T2
|
|
|
JP
8506243 T2
|
|
|
JP
9503759 T2
|
|
|
JP
9506508 T2
|
|
|
NO
316274 B1
|
Fremgangsmate
til refolding av proteiner (Norwegian)
|
|
US
5739281
|
Interative
method of at least three cycles for the refolding of
proteins
|
|
US
5837242
|
Multivalent
and multispecific binding proteins, their manufacture and
use
|
|
US
5917018
|
Interative
method of at least five cycles for the refolding of
proteins
|
|
US
6010884
|
Recombinant
binding proteins and peptides
|
|
US
6492123
|
Multivalent
and multispecific binding proteins, their manufacture and
use
|
|
US
6589527
|
Retargeting
antibodies
|
|
WO
9413804
|
Multivalent
and multispecific binding proteins, their manufacture and
use
|
|
WO
9418227
|
Improved
method for the refolding of proteins
|
|
WO
9508577
|
Retargeting
antibodies
|
|
WO
9515388
|
Recombinant
binding proteins and peptides
|
Schedule
1
- Page 7
|
Family
7 (includes PCT/GB97/01835)
|
|
|
Patent
or Publication No.
|
Title
|
|
AU
715796 B2
|
Labelling
and selection of molecules
|
|
EP
906571 B1
|
Labelling
and selection of molecules
|
|
EP
1353180 B1
|
Labelling
and selection of molecules
|
|
GB
9614292 A0
|
Labelling
and selection of specific binding molecules
|
|
GB
9624880 A0
|
Labelling
and selection of specific binding molecules
|
|
GB
9712818 A0
|
Labelling
and selection of specific binding molecules
|
|
GB
9714397 A0
|
Labelling
and selection of molecules
|
|
GB
9900205 A0
|
Labelling
and selection of molecules
|
|
GB
2330909 B2
|
Labelling
and selection of molecules
|
|
GB
2315125 B2
|
Labelling
and selection of molecules
|
|
JP
2000517046 T2
|
|
|
US
5994519
|
Labelling
and selection of molecules
|
|
US
6180336
|
Labelling
and selection of molecules
|
|
US
6342588
|
Labelling
and selection of molecules
|
|
US
6489123
|
Labelling
and selection of molecules
|
|
US
20020004215
|
Labelling
and selection of molecules
|
|
WO
9801757
|
Labelling
and selection of
molecules
|
Schedule
1
- Page 8
Schedule
2
For
each
Nominated Target (which must be accompanied by a GenBank® accession number or
similar information which uniquely identifies that Nominated Target) submitted
by Dyax under Clause 4.1, CAT will, on a Nominated -Target-by-Nominated -Target
basis, not grant a Dyax Product Licence to Dyax, if:
|
1.
|
CAT
is, at the date of submission of the Target Option Notice by Dyax,
contractually obligated on an exclusive basis in respect of that
Nominated
Target with a Third Party pursuant to an agreement with that Third
Party
which was entered into prior to 3 January 2003;
or
|
|
2.
|
CAT
is, at the date of submission of the Target Option Notice by Dyax,
engaged
in internal research and/or development with respect to such a
Nominated
Target (as can be measured by reliable or verifiable
means).
|
|
1.
|
For
the avoidance of doubt, CAT will not subject any Nominated Target
to the
CAT Gatekeeping Procedure unless and until Dyax supplies CAT with
a
GenBank® accession number or similar information which uniquely identifies
that Nominated Target.
|
|
2.
|
If
Dyax supplies CAT with an incorrect GenBank® accession number for a
Nominated Target or otherwise incorrectly identifies a Nominated
Target
which is then subjected to the CAT Gatekeeping Procedure, the result
of
the CAT Gatekeeping Procedure in respect of such Nominated Target
shall
prevail even if it is subsequently discovered that such incorrect
GenBank®
accession number or identifying information had been provided by
Dyax.
|
|
3.
|
Within
one (1) month after notice is given to Dyax of a refusal by CAT
to grant a
Dyax Product Licence in respect of any Nominated Target, Dyax may
notify
CAT that it wishes to appoint an Expert to make such enquiries
of CAT as
may be reasonably necessary for the Expert to be able to confirm
to Dyax
that the CAT Gatekeeping Procedure had been correctly applied by
CAT in
respect of such Nominated Target. CAT shall provide such
information to the Expert as the Expert may reasonably determine
is
required in order to make such confirmation. For the avoidance
of doubt the Expert shall not be entitled (unless CAT consents)
to enter
CAT premises in order to carry out its enquiries, shall only provide
the
confirmation to Dyax on a "Yes/No" basis and shall not give or
be obliged
to give to Dyax any other information obtained from CAT in respect
of the
CAT Gatekeeping Procedure or the relevant Nominated Target. The
Expert shall, prior to making any enquiries of CAT, enter into
a
confidential disclosure agreement with CAT. Notwithstanding the
foregoing, CAT shall not be obliged to respond to the enquiries
of the
Expert if to do so would, or would reasonably be expected to, cause
a
breach in terms of any agreement CAT may have with any other Third
Parties; provided, however, that such disclosure subject to the
confidential disclosure agreement shall be treated by CAT in the
same
manner as disclosure in its normal business operations. The Expert
shall
complete its investigations and provide the confirmation to Dyax
(with a
copy to CAT) within thirty (30) days after appointment by Dyax,
and
payment of the Expert's fee shall be conditioned on such delivery
being
timely made. If such written confirmation is not made within
such thirty (30) days period, then a replacement Expert shall be
appointed
within 10 days thereafter, subject to same terms and conditions
stated
above.
|
Schedule
2
- Page 1
| If an Expert provides notice that he or she cannot complete the analysis because CAT has failed without good reason to provide any information requested as provided above, then CAT shall have no more than 30 days to provide the information and the Expert shall then have no more than 15 days after the information is provided to the Expert to evaluate the information and make a determination. Failure of the second Expert to provide such written confirmation to Dyax on a "Yes/No" basis within thirty (30) days after appointment shall be irrevocably deemed to be confirmation that CAT correctly applied the CAT Gatekeeping Procedure to the Nominated Target in question, provided, however that until (i) CAT provides all information that it is required to provide in accordance with this Schedule 2 and (ii) the expiration of any extension required for the Expert to evaluate such information, there shall not be deemed to be any such confirmation that CAT correctly applied the CAT Gatekeeping Procedure to the Nominated Target in question. |
If
the
Expert appointed by Dyax hereunder decides that CAT correctly applied, or
is
deemed to have correctly applied, the CAT Gatekeeping Procedure, Dyax shall
be
responsible for the Expert's fees and CAT shall thereafter have no obligations
to Dyax in respect of such Nominated Target. If the Expert decides
that CAT did not correctly apply the CAT Gatekeeping Procedure Dyax shall
be
granted a Dyax Product Licence in relation to the Nominated Target in question
(provided that CAT is not restricted by obligations to any Third Party in
relation to the Nominated Target in question in which case the Dyax Product
Licence will be subject to those restrictions) and CAT shall be responsible
for
the Expert's fees. "Expert" shall mean a patent
agent who is independent of CAT and all of the other parties with an interest
in
the outcome of a determination regarding a Nominated Target, who has suitable
knowledge and experience in the reasonable opinion of Dyax to perform the
above
activities, subject to CAT's consent, which consent shall not be unreasonably
withheld or delayed.
Schedule
2
- Page 2
Schedule
3
CAT
Know-How
[*****]
Schedule
3
- Page 1
Schedule
4
[RESERVED]
Schedule
5
Dyax
Patent Rights
A. Dyax
Base Phage Display Patent Rights
|
COUNTRY
|
SERIAL
NO.
|
TITLE
|
PUB.
NO.
|
PATENT
NO.
|
|
AT
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
E262036
|
|
CA
|
610176
|
GENERATION
AND SELECTION OF NOVEL DNA-BINDING
PROTEINS
AND POLYPEPTIDES
|
1340288
|
|
|
CA
|
2105300
|
PROCESS
FOR THE DEVELOPMENT OF BINDING MINI-PROTEINS
|
||
|
CH
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
|
|
DE
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
DE
69233325T2
|
69233325.8-08
|
|
DK
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
0573611
|
|
EP
|
89910702.3
|
GENERATION
AND SELECTION OF RECOMBINANT VARIED
BINDING
PROTEINS
|
EP0436597
|
0436597
|
|
EP
|
02015673.3
|
PROCESS
FOR THE DEVELOPMENT OF BINDING MINI-PROTEINS
|
EP1279731
|
|
|
EP
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
EP0573611
|
0573611
|
|
EP
|
04006079.0
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
1452599
|
|
|
EP
|
05000796.2
|
GENERATION
AND SELECTION OF RECOMBINANT VARIED
BINDING
PROTEINS
|
EP1541682
|
|
|
ES
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
0573611
|
|
FR
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
|
|
GR
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
3049248
|
|
|
IE
|
2834/89
|
GENERATION
AND SELECTION OF RECOMBINANT VARIED
BINDING
PROTEINS
|
||
|
IL
|
91501
|
GENERATION
AND SELECTION OF RECOMBINANT VARIED
BINDING
PROTEINS
|
91501
|
|
|
IL
|
120941
|
CHIMERIC
BINDING PROTEIN
|
120941
|
120941
|
|
IL
|
120940
|
FUSION
PROTEINS DISPLAYED DISPLAYABLE ON THE SURFACE OF
FILAMENTOUS
PHAGE AND A RECOMBINANT
FILAMENTOUS
PHAGE
BEARING SAME
|
120940
|
|
|
IL
|
120939
|
METHOD
FOR OBTAINING NUCLEIC ACID ENCODING A
PROTEINACOUS
BINDING DOMAIN
|
120939
|
Schedule
5
- Page 1
|
IT
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
|
|
JP
|
510087/1989
|
GENERATION
AND SELECTION OF RECOMBINANT
VARIED
BINDING PROTEINS
|
3771253
|
|
|
JP
|
507558/1992
|
PROCESS
FOR THE DEVELOPMENT OF BINDING MINI-PROTEINS
|
||
|
JP
|
508216/1992
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
3447731
|
|
|
JP
|
130929/2003
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
▇▇▇▇-▇▇▇
|
|
|
▇▇
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
0573611
|
|
SE
|
92908799.7
|
IMPROVED
EPITOPE DISPLAYING PHAGE
|
0573611
|
|
|
US
|
07/664,989
|
DIRECTED
EVOLUTION OF NOVEL BINDING PROTEINS
|
5,223,409
|
|
|
US
|
08/009,319
|
VIRUSES
EXPRESSING CHIMERIC BINDING PROTEINS
|
5,403,484
|
|
|
US
|
08/057,667
|
DIRECTED
EVOLUTION OF NOVEL BINDING PROTEINS
|
5,571,698
|
|
|
US
|
08/415,922
|
DIRECTED
EVOLUTION OF NOVEL BINDING PROTEINS
|
5,837,500
|
|
|
US
|
09/781,988
|
DIRECTED
EVOLUTION OF NOVEL BINDING PROTEINS
|
US-2002-0150881
A1
|
6,979,538
|
|
US
|
09/893,878
|
DIRECTED
EVOLUTION OF NOVEL BINDING PROTEINS
|
US-2003-0113717
A1
|
7,208,293
|
|
US
|
10/126,544
|
METHOD
OF RECOVERING A NUCLEIC ACID ENCODING A
PROTEINACEOUS
BINDING DOMAIN WHICH
BINDS A
TARGET
MATERIAL
|
US-2004-0023205a1
|
7,118,879
|
|
US
|
10/207,797
|
DIRECTED
EVOLUTION OF DISULFIDE BONDED MICROPROTEINS
|
US-2006-0084113-A1
|
|
|
WO
|
PCT/US92/01456
|
PROCESS
FOR THE DEVELOPMENT OF BINDING MINI-PROTEINS
|
▇▇▇▇▇▇▇▇▇
|
|
|
WO
|
PCT/US92/01539
|
IMPROVED
DISPLAY PHAGE
|
WO92/15679
|
|
|
WO
|
PCT/US89/03731
|
GENERATION
AND SELECTION OF RECOMBINANT VARIED
BINDING
PROTEINS
|
WO9002809
|
Schedule
5
- Page 2
B. Dyax
Library-Related Patent Rights
|
COUNTRY
|
SERIAL
NO.
|
TITLE
|
PUB.
NO.
|
PATENT
NO.
|
|
AU
|
▇▇▇▇▇▇▇▇▇▇
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
WO02/061071
A2
|
|
|
CA
|
2432377
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
||
|
EP
|
01998098.6
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
▇▇▇▇▇▇▇▇▇
|
|
|
JP
|
2002-561628
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
||
|
US
|
11/416,460
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
US-2006-0257937-A1
|
|
|
WO
|
PCT/US01/50297
|
FOCUSED
LIBRARIES OF GENETIC PACKAGES
|
||
|
AU
|
2001253589
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES
OF
HUMAN FAB ANTIBODY
FRAGMENTS DISPLAYED
ON
FILAMENTOUS PHAGE (CJ Library)
|
||
|
AU
|
2002307422
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING
DISPLAYED
AND/OR EXPRESSED
MEMBERS OF A DIVERSE
FAMILY
OF PEPTIDES, POLYPEPTIDES OR PROTEINS AND
THE
NOVEL LIBRARIES
|
||
|
CA
|
2406236
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES OF
HUMAN
FAB ANTIBODY FRAGMENTS
DISPLAYED ON
FILAMENTOUS
PHAGE
|
||
|
CA
|
2458462
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING
DISPLAYED
AND/OR EXPRESSED
MEMBERS OF A DIVERSE
FAMILY
OF PEPTIDES, POLYPEPTIDES OR PROTEINS AND
THE
NOVEL LIBRARIES
|
||
|
EP
|
01927108.9
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES OF
HUMAN
FAB ANTIBODY FRAGMENTS
DISPLAYED ON
FILAMENTOUS
PHAGE
|
EP1276855
|
|
|
EP
|
02762148.1
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING
DISPLAYED
AND/OR EXPRESSED
MEMBERS OF A DIVERSE
FAMILY
OF PEPTIDES, POLYPEPTIDES OR PROTEINS AND
THE
NOVEL LIBRARIES
|
EP1578903
|
|
|
JP
|
2001-577464
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES OF HUMAN
FAB
ANTIBODY FRAGMENTS
DISPLAYED ON FILAMENTOUS PHAGE
|
||
|
JP
|
PCT/US02/12405
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING
DISPLAYED
AND/OR
EXPRESSED MEMBERS OF A DIVERSE FAMILY
OF
PEPTIDES, POLYPEPTIDES OR
PROTEINS AND THE NOVEL
LIBRARIES
|
||
|
US
|
10/045,674
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING
DISPLAYED
AND/OR EXPRESSED
MEMBERS OF A DIVERSE FAMILY
OF
PEPTIDES, POLYPEPTIDES OR PROTEINS AND
THE
NOVEL
LIBRARIES
|
US
2003-0232333 A1
|
Schedule
5
- Page 3
|
US
|
11/365,556
|
NOVEL
METHODS OF CONSTRUCTING LIBRARES COMPRISING DISPLAYED AND/OR
EXPRESSED
MEMBERS OF A DIVERSE FAMILY OF PEPTIDES, POLYPEPTIDES OR
PROTEINS
AND NOVEL LIBRARIES
|
US-2006-0166252-A1
|
|
|
WO
|
PCT/US01/12454
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES OF HUMAN FAB
ANTIBODY
FRAGMENTS DISPLAYED ON FILAMENTOUS PHAGE
|
2003-530853
|
|
|
WO
|
PCT/US02/12405
|
NOVEL
METHODS OF CONSTRUCTIONG LIBRARIES COMPRISING DISPLAYED
AND/OR
EXPRESSED MEMBERS OF A DIVERSE FAMILY OF PEPTIDES, POLYPEPTIDES
OR
PROTEINS AND THE NOVEL LIBRARIES
|
WO02083872
|
|
|
US
|
10/383,902
|
LIGAND
SCREENING AND DISCOVERY
|
US
2003-0224408 A1
|
|
|
AU
|
51422/00
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
780145
|
|
|
CA
|
2372582
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
||
|
EP
|
99201558.6
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
EP1054018
|
|
|
JP
|
2000-618429
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
||
|
US
|
09/988,899
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
US
2002-0102613 A1
|
|
|
WO
|
PCT/US00/13682
|
NOVEL
FAB FRAGMENT LIBRARIES AND METHODS FOR THEIR USE
|
WO00/70023
|
Schedule
5
- Page 4
Schedule
6
Dyax
Antibody Libraries, Dyax Materials and Dyax
Know-How
[*****]
Schedule
6
- Page 1
Schedule
7
Private
& Confidential
DATED
AS OF ________________, 200
____________________________________
CAMBRIDGE
ANTIBODY TECHNOLOGY LIMITED (1)
and
DYAX
CORP. (2)
____________________________________
DYAX
PRODUCT LICENCE FOR [ ]
_____________________________________
Schedule
7
- Page 1
THIS
AGREEMENT is made as of ____________________, 200___
BETWEEN:
|
(1)
|
CAMBRIDGE
ANTIBODY TECHNOLOGY LIMITED (Registered in England No. 2451177)
whose registered office is at The ▇▇▇▇▇▇▇▇ Building, Granta Park,
Cambridge, Cambridgeshire, CB1 6GH, UK
("CAT").
|
|
(2)
|
DYAX
CORP. a corporation organised and existing under the laws of
the
State of Delaware having its principal place of business at ▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇
("Dyax").
|
|
(a)
|
By
the terms of the Amended and Restated Agreement (as defined below),
CAT
granted Dyax certain options to be granted Dyax Product Licences
under the
Antibody Phage Display Patents and CAT Know How (all as defined
below).
|
|
(b)
|
Dyax
has nominated the Target (which was identified prior to the execution
of
the Amended and Restated Agreement), and this Target has passed
the CAT
Gatekeeping Procedure (each as defined
below).
|
|
(c)
|
By
this Agreement CAT wishes to grant to Dyax a Dyax Product Licence
in
respect of Diagnostic Antibody Products and Therapeutic Antibody
Products
against the Target.
|
In
consideration of the mutual covenants and undertakings set out below,
THE PARTIES AGREE as follows:
|
1.1
|
In
this Agreement, the terms defined in this Clause shall have the
meanings
specified below:
|
|
|
"Acceptance
Fee" means [*****].
|
|
|
[*****].
|
|
|
"Affiliate"
means any company, partnership or other entity which directly or
indirectly Controls, is Controlled by or is under common Control
with any
other entity.
|
|
|
"Agreement" means
this Dyax Product Licence and any and all Schedules, appendices
and other
addenda to it as may be amended from time to time in accordance
with the
provisions of this agreement.
|
|
|
"Amended
Agreement" means the Amended and Restated
Agreement executed by Dyax and CAT on July 30,
2007.
|
Schedule
7
- Page 2
|
|
"Antibody" means
a molecule or a gene encoding such a molecule comprising or containing
one
or more immunoglobulin variable domains or parts of such domains
or any
existing or future fragments, variants, modifications or derivatives
thereof.
|
|
|
"Antibody
Library" means any antibody library constructed using processes
which are covered by a claim of an issued and unexpired patent
included
within the Antibody Phage Display Patents which has not been held
permanently revoked, unenforceable or invalid by a decision of
a court or
other governmental agency of competent jurisdiction unappealed
within the
time allowed for appeal, and which has not been admitted to be
invalid or
unenforceable through reissue or disclaimer or
otherwise.
|
|
|
"Antibody
Phage Display Patents" means: (a) the patents and
patent applications listed in Schedule 1 and any patents issuing
from such patent applications, together with any divisions, registrations,
confirmations, reissues, extensions, renewals, continuations,
continuations-in-part, revalidations, additions, substitutions,
renewals
or supplementary protection certificates thereof throughout the
world; and
(b) any Patent Rights which claim or cover any invention or discovery
which is developed by CAT or its Affiliates at any time during
the term of
this Agreement directly related to Antibody phage display or Antibody
Services; provided, however, that Antibody Phage Display Patents
shall always exclude (i) CAT Diabodies Patent Rights, (ii) any
Patent
Rights owned or controlled by CAT which claim or cover Catalytic
Antibodies, (iii) any Patent Rights owned or controlled by CAT
which claim
ribosome display technology, (iv) any Patent Rights which claim
Single
Domain Antibodies, and (v) any Patent Rights acquired by CAT after
the
Commencement Date from any Third Party for consideration or as
a result of
CAT's acquisition of or merger with such Third
Party.
|
|
|
"Antibody
Services" means the provision of research and/or development
services for the identification, generation, derivation or development
of
one or more CAT Antibody Libraries or Antibodies derived
therefrom.
|
|
|
"Business
Day" means a day (other than a Saturday or Sunday) on which
the
banks are ordinarily open for business in the City of London and
the
Commonwealth of Massachusetts.
|
|
|
"CAT
Diabodies Patent Rights" means (a) the
Patent Rights entitled "Diabodies – multivalent and multispecific binding
proteins, their manufacture and use", PCT/GB93/02492 and (b) the
Patent
Rights entitled "Retargeting antibodies and diabodies",
PCT/GB94/02019.
|
|
|
"CAT
Gatekeeping Procedure" means the procedure set out in Schedule
2 of the Amended Agreement which CAT has carried out in respect
of the
Target prior to the grant of this Dyax Product
Licence.
|
|
|
"CAT
Know-How" means any Confidential
Information of CAT which constitutes unpatented know-how, technical
and
other information related to the subject matter of the Antibody
Phage
Display Patents as identified in Schedule 2 and as amended from
time to time in accordance with Schedule
2.
|
|
|
"CAT
Licensable Antibody" means any Antibody (including any
Bi-Specific or Poly-Specific Antibody) to the Target (a) where
such
Antibody has been identified, generated, developed, produced or
derived by
Dyax or a Dyax Sublicensee or its sublicensees and (b) the identification,
generation, development, production or derivation of such Antibody
uses
any of the processes claimed or covered by a claim of an issued
and
unexpired patent included within the Antibody Phage Display Patents
(which
has not been held permanently revoked, unenforceable or invalid
by a
decision of a court or other governmental agency of competent jurisdiction
unappealed within the time allowed for appeal, and which has not
been
admitted to be invalid or unenforceable through reissue or disclaimer
or
otherwise) or uses the CAT Know-How and (c) which is potentially
useful
for the development of any Diagnostic Antibody Product and/or any
Therapeutic Antibody Product.
|
Schedule
7
- Page 3
|
|
"Catalytic
Antibodies" means solely those Antibodies
which bind to and catalyze the chemical transformation of a substrate
and
in which an Antibody binding region is involved in said
catalysis.
|
|
|
"Commencement
Date" means the date of this Agreement first written
above.
|
|
|
"Competent
Authority" means any national or local agency, authority,
department, inspectorate, minister, ministry official, parliament
or
public or statutory person (whether autonomous or not) of any government
of any country having jurisdiction over either any of the activities
contemplated by this Agreement or the Parties including the European
Commission, the Court of First Instance and the European Court
of
Justice.
|
|
|
"Controls"
means the ownership, directly or indirectly, of more than fifty
percent
(50%) of the outstanding equity securities of a corporation which
are
entitled to vote in the election of directors or a more than fifty
percent
(50%) interest in the net assets or profits of an entity which
is not a
corporation.
|
|
|
"Diagnostic
Antibody Product" means any preparation in the form of a device,
compound, kit or service with utility in the diagnosis, prognosis,
prediction or disease management of a disorder for any indication
which
contains, comprises or the process of development or manufacture
of which
utilises a CAT Licensable Antibody. The term "Diagnostic
Antibody Product" shall not include any Research
Product,
|
|
|
"Dyax
Therapeutic Antibody Product" means any Therapeutic Antibody
Product identified, generated or derived by Dyax for itself or
its
Affiliates but not a Therapeutic Antibody Product identified, generated
or
derived by Dyax for, or on behalf of, a Third
Party.
|
"Dyax
Sublicensee" means any Third Party who is granted a sublicense under
Clause 3.4 of this Agreement to Exploit Products against the Target in the
Territory.
|
|
"Exploit"
means to make, have made, use, sell or
import.
|
|
|
"FDA"
means the United States Food and Drug Administration, the equivalent
Competent Authority in any country of the Territory or any successor
bodies thereto.
|
|
|
"First
Commercial Sale" means the first commercial sale of any Product
by Dyax or a Dyax Sublicensee (or its sublicensee) in any country
after
grant of a Marketing Authorisation.
|
Schedule
7
- Page 4
|
|
"Force
Majeure" means any event outside the reasonable control of either
Party affecting its ability to perform any of its obligations (other
than
payment) under this Agreement, including Act of God, fire, flood,
lightning, war, revolution, act of terrorism, riot or civil commotion,
but
excluding strikes, lock-outs or other industrial action, whether
of the
affected Party's own employees or others, failure of supplies of
power,
fuel, transport, equipment, raw materials or other goods or
services.
|
|
|
"GAAP"
means United States generally accepted accounting principles, consistently
applied.
|
|
|
"IDE" means
an Investigational Device Exemption application, as defined in
Title 21 of
the United States Code of Federal Regulations, filed with the FDA
or an
equivalent foreign filing.
|
|
|
"IND" means
an Investigational New Drug Application, as defined in Title 21
of the
United States Code of Federal Regulations, that is required to
be filed
with the FDA before beginning Phase I Clinical Trials of any Therapeutic
Antibody Product in human subjects, or an equivalent foreign
filing.
|
|
|
"Major
Market" means any one of the following: (i) the United
States of America, (ii) any country in Europe which is subject to the
Marketing Authorisation procedure of the European Medicines Evaluation
Agency, or (iii) Japan.
|
|
|
"Marketing
Authorisation" means any approval (including all applicable
pricing and governmental reimbursement approvals) required from
the FDA or
relevant Competent Authority to market and sell a Product in a
particular
country.
|
|
|
"Net
Sales" means, with respect to a Product sold by Dyax or a Dyax
Sublicensee (or its sublicensees), the price invoiced by that party
to the
relevant purchaser (or in the case of a sale or other disposal
otherwise
than at arm's length, the price which would have been invoiced
in a bona
fide arm's length contract or sale) but deducting the costs of
packing,
transport and insurance, customs duties, any credits actually given
for
returned or defective Products, normal trade discounts actually
given, and
sales taxes, VAT or other similar tax charged on and included in
the
invoice price to the purchaser.
|
|
|
"Party"
means CAT or Dyax.
|
|
|
"Patent
Rights" means any patent applications and any patents issuing
from such patent applications, author certificates, inventor certificates,
utility certificates, improvement patents and models, and certificates
of
addition and all counterparts of them throughout the Territory,
including
any divisional applications and patents, filings, renewals, continuations,
continuations-in-part, patents of addition, extensions, reissues,
substitutions, confirmations, registrations, revalidation and additions
of
or to any of them, as well as any supplementary protection certificates
and equivalent protection rights in respect of any of
them.
|
|
|
"Pharmacia
Agreement" means the agreement between CAT and Pharmacia P-L
Biochemicals Inc. dated 11 September
1991.
|
Schedule
7
- Page 5
|
|
"Pharmacia
P-L Biochemicals Inc." means Pharmacia P-L
Biochemicals Inc (now known as Amersham
Biosciences).
|
|
|
"Phase
I Clinical Trial" means a human clinical trial in any country
that is intended to initially evaluate the safety of an investigational
Product in volunteer subjects or patients that would satisfy the
requirements of 21 CFR 312.21(a), or its foreign equivalent and
may
evaluate the Product's therapeutic or antigenic
effects.
|
|
|
"Phase
III Clinical Trial" means a pivotal human clinical trial in any
country the results of which could be used to establish safety
and
efficacy of a Product as a basis for a marketing application that
would
satisfy the requirements of 21 CFR
312.21(c).
|
|
|
"Primary
Application" means a major application of an Antibody against the
Target as ascertained at the time of assessment using objective
and
reasonable scientific and/or commercial criteria, data and/or
information. Primary Application shall not mean any minor or
incidental application.
|
|
|
"Product"
means a Diagnostic Antibody Product or a Therapeutic Antibody
Product.
|
|
|
"Dyax
Product Licence" means the licence granted to Dyax pursuant to
Clause 2 of this Agreement.
|
|
|
"Quarter"
means each period of three (3) months ending on March 31, June
30,
September 30, or December 31 and "Quarterly" shall be
construed accordingly.
|
|
|
"Research
Products" means any product in relation to
which Pharmacia P-L has an exclusive licence from CAT pursuant
to the
Pharmacia Agreement.
|
|
|
"Single
Domain Antibodies" means an Antibody containing only a single
domain (heavy or light).
|
|
|
"Status
Report" has the meaning set forth in Clause
4.1.
|
|
|
"Target"
means [ ], as set out in
Schedule 3.
|
|
|
"Territory"
means all countries of the world.
|
|
|
"Therapeutic
Antibody Product" means any preparation for the treatment or
prevention of disease, infection or other condition in humans for
any
indication which contains, comprises, or the process of development
or
manufacture of which utilises, a CAT Licensable Antibody. The
term "Therapeutic Antibody Product" shall not include any
Research Product, "Third Party" means any entity or
person other than Dyax, CAT or their respective
Affiliates.
|
|
|
"Valid
Claim" means a claim of an issued and
unexpired patent included within the Antibody Phage Display Patents
which
have been licensed to CAT by the MRC which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction unappealed within
the time
allowed for appeal, and which has not been admitted to be invalid
or
unenforceable through reissue or disclaimer or
otherwise.
|
Schedule
7
- Page 6
|
|
"Year"
means initially the period from the Commencement Date to the end
of that
calendar year, and subsequently a calendar
year.
|
|
1.2
|
The
headings to clauses are inserted for convenience only and shall
not affect
the interpretation or construction of this
Agreement.
|
|
1.3
|
Words
imparting the singular shall include the plural and vice
versa. References to persons include an individual, company,
corporation, firm or partnership.
|
|
1.4
|
The
words and phrases "other", "including" and "in particular" shall
not limit
the generality of any preceding words or be construed as being
limited to
the same class as any preceding words where a wider construction
is
possible.
|
|
1.5
|
References
to any statute or statutory provisions of the United Kingdom shall
include
(i) any subordinate legislation made under it, (ii) any provision
which it has superseded or re-enacted (whether with or without
modification), and (iii) any provision which subsequently supersedes
it or
re-enacts it (whether with or without modification. References
to any statute or regulation of the United States of America means
that
statute or regulation as it may be amended, supplemented or otherwise
modified from time to time, and any successor statute or
regulation.
|
|
2.1
|
Subject
to Clause 2.4 below, CAT hereby grants to Dyax and its Affiliates
a
non-exclusive, royalty-bearing licence (on the terms of this Agreement)
with the right to sublicense (on the terms of Clause 3) under the
Antibody
Phage Display Patents and CAT Know-How to Exploit Products against
the
Target in the Territory.
|
|
2.2
|
The
Dyax Product Licence granted under this Agreement is pursuant to
Dyax's
exercise of one (1) option from the [*****] under the Amended
Agreement.
|
|
2.3
|
For
the avoidance of doubt, no rights are granted by CAT under this
Agreement
to any CAT Diabodies Patent Rights, and any Patent Rights owned
or
controlled by CAT which claim Catalytic Antibodies, ribosome display
technology, any Patent Rights which claim Single Domain Antibodies
and no
rights are granted by CAT in this Agreement under the Antibody
Phage
Display Patents to Exploit Research
Products.
|
|
2.4
|
This
Dyax Product Licence shall come into effect upon the date that
the
Acceptance Fee is received by CAT. The Acceptance Fee shall not
be refundable or creditable against any other sums which may be
payable by
Dyax or a Dyax Sublicensee to CAT pursuant to this
Agreement.
|
Schedule
7
- Page 7
|
3.1
|
Dyax
will, if requested by CAT, inform CAT of the identity of all Dyax
Sublicensees (and their sublicensees) in relation to this
Agreement.
|
|
3.2
|
Dyax
will ensure that any Third Party which receives a sublicence of
its rights
in accordance with the terms of this Agreement executes a written
agreement which requires the Third Party to abide bythe terms of
this
Agreement.
|
|
3.3
|
Dyax
will be liable for any breach of the sublicences granted in accordance
with Clause 3.2.
|
|
3.4
|
For
the avoidance of doubt, the rights granted to Dyax to Exploit Products
against the Target in the Territory may be sublicensed to one or
more
Third Parties (and further sublicensed by any such Third Party),
provided
that any such sublicense would remain subject to the terms and
conditions
of this Agreement.
|
|
4.1
|
Dyax
will provide to CAT a brief summary of the status of each Product
against
the Target that Dyax or Dyax Sublicensees desire to Exploit under
this
Agreement ("Status Report"). During the Term,
Dyax will submit such Status Report to CAT for a particular Product
prior
to the time Dyax or Dyax Sublicensees begin the first human clinical
trial
with respect to such
Product. [*****].
|
5. Gatekeeping
The
Parties acknowledge that, as of the Commencement Date, the Target has passed
CAT's Gatekeeping Procedure under the Amended Agreement.
|
|
6.1.1
|
With
respect to Therapeutic Antibody Products, Dyax shall pay to CAT
the
following payments upon achievement of the specified milestones
by Dyax or
a Dyax Sublicensee (or its sublicensee) for the first Therapeutic
Antibody
Product to achieve the relevant
milestone:
|
|
Initiation
of first Phase I Clinical Trial
|
US
$[*****]
|
|
Initiation
of first Phase III Clinical Trial
|
US
$[*****]
|
|
First
filing for Marketing Authorisation in one Major Market
country
|
US
$[*****]
|
|
Marketing
Authorisation granted in the United States
|
US
$[*****]
|
Schedule
7
- Page 8
|
|
6.1.2
|
With
respect to Therapeutic Antibody Products, Dyax shall pay CAT royalties
in
an amount equal to [*****] percent [*****] of Net
Sales of the Therapeutic Antibody Product sold by or on behalf
of Dyax or
the Dyax Sublicensee.
|
|
|
6.2.1
|
With
respect to Diagnostic Antibody Products, Dyax shall pay to CAT
the
following payments upon achievement by Dyax or a Dyax Sublicensee
(or its
sublicensee) of the milestones set out below. For the avoidance
of doubt the milestone payments shall be payable in respect of
the first
Diagnostic Antibody Product to achieve the relevant
milestone:
|
|
First
filing for Marketing Authorisation in one Major Market
country
|
US
$[*****]
|
|
Marketing
Authorisation granted in each Major Market Country
|
US
$[*****]
|
|
|
6.2.2
|
With
respect to Diagnostic Antibody Products, Dyax shall pay CAT royalties
on a
country-by-country basis in an amount equal to [*****] of Net Sales
of
Diagnostic Antibody Products sold by or on behalf of Dyax or any
Dyax
Sublicensee.
|
|
6.3
|
All
royalties due to CAT pursuant to Clauses 6.1.2 and 6.2.2 shall
be payable
on a country-by-country basis until the last Valid Claim expires
or ten
(10) years from the date of First Commercial Sale of such Product,
whichever occurs later.
|
|
7.1
|
All
milestone payments shall be paid by Dyax within [*****] days of
the
applicable milestone being achieved and no milestone payments shall
be
refundable or creditable against any other sum payable by Dyax
hereunder
for any reason.
|
|
7.2
|
Dyax
shall make the payments due to CAT under Clause 6 above in United
States
dollars (if Dyax in turn receives payment in dollars) or in pounds
sterling (if Dyax in turn receives payment in pound sterling),
or Euros
(if Dyax in turn receives payment in Euros). Where Dyax
receives payment in a currency other than United States dollars,
pounds
sterling or Euros, Dyax will convert the relevant sum into pounds
sterling
(or Euros if Euros have replaced pounds sterling at the time of
payment). Dyax will use the conversion rate reported in the
Financial Times two (2) Business Days before the day on which Dyax
pays
CAT. Such payment will be made without deduction of exchange,
collection or other charges. All payments will be made at
Quarterly intervals. Within [*****] days of the end of each
Quarter after the First Commercial Sale of each Product in any
country,
Dyax shall prepare a statement which shall show on a country-by-country
basis for the previous Quarter Net Sales of each Product by Dyax
or its
Affiliates and all monies due to CAT based on such Net
Sales. That statement shall include details of Net Sales broken
down to show the country of the sales and the total Net Sales by
Dyax or
its Affiliates in such country and shall be submitted to CAT within
such
[*****] day period together with remittance of the monies
due. With respect to Net Sales of a Product by a Dyax
Sublicensee (or its sublicensee) Dyax shall prepare a statement
which will
include the same information and remit that statement and any monies
due
within the same period except with regard to any Dyax Sublicensee
with
which Dyax has a licence agreement relating to the technology of
Antibody
phage display as of the Commencement Date where the remittance
will be
made at Quarterly intervals within [*****] days of the date royalties
are
due to Dyax from such existing Dyax
Sublicensees.
|
Schedule
7
- Page 9
|
7.3
|
All
payments shall be made free and clear of and without deduction
or
deferment in respect of any disputes or claims whatsoever and/or
as far as
is legally possible in respect of any taxes imposed by or under
the
authority of any government or public
authority. [*****].
|
|
7.4
|
Dyax
shall keep and shall procure that its Affiliates and Dyax Sublicensees
keep true and accurate records and books of account containing
all data
necessary for the calculation of the amounts payable by it to CAT
pursuant
to this Agreement. Those records and books of account shall be
kept for seven (7) years following the end of the Year to which
they
relate. Upon CAT's written request, a firm of accountants
appointed by agreement between the Parties or, failing such agreement
within ten (10) Business Days of the initiation of discussions
between
them on this point CAT shall have the right to cause an international
firm
of independent certified public accountants that has not performed
auditing or other services for either Party or their Affiliates
(or, if
applicable, any Dyax Sublicensee with rights to the Product in
question)
acceptable to Dyax or the Dyax Sublicensee such acceptance not
to be
unreasonably withheld to inspect such records and books of
account. In particular such
firm:
|
|
|
7.4.1
|
shall
be given access to and shall be permitted to examine and copy such
books
and records of Dyax and its Affiliates and Dyax Sublicensees upon
twenty
(20) Business Days notice having been given by CAT and at all reasonable
times on Business Days for the purpose of certifying that the Net
Sales or
other relevant sums calculated by Dyax and its Affiliates and Dyax
Sublicensees during any Year were reasonably calculated, true and
accurate
or, if this is not their opinion, certify the Net Sales figure
or other
relevant sums for such period which in their judgment is true and
correct;
|
|
|
7.4.2
|
prior
to any such examination taking place, such firm of accountants
shall
undertake to Dyax and its Affiliates and Dyax'
Sublicensees that they shall keep all information
and data contained in such books and records, strictly confidential
and
shall not disclose such information or copies of such books and
records to
any third person including CAT, but shall only use the same for
the
purpose of calculations which they need to perform in order to
issue the
certificate to which this Clause
envisages;
|
|
|
7.4.3
|
any
such access examination and certification shall occur no more than
once
per Year and will not go back over records more than two (2) years
old;
|
|
|
7.4.4
|
Dyax
and its Affiliates and Dyax Sublicensees shall make available personnel
to
answer queries on all books and records required for the purpose
of that
certification; and
|
|
|
7.4.5
|
the
cost of the accountant shall be the responsibility of Dyax if the
certification shows it to have underpaid monies to CAT by more
than
[*****] and the responsibility of CAT
otherwise.
|
Schedule
7
- Page 10
|
7.5
|
All
payments due to CAT under the terms of this Agreement are expressed
to be
exclusive of value added tax (VAT) howsoever
arising. [*****].
|
|
7.6
|
All
payments made to CAT under this Agreement shall be made to the
bank
account of CAT as notified by CAT to Dyax from time to
time.
|
|
7.7
|
If
Dyax fails to make any payment to CAT hereunder on the due date
for
payment, without prejudice to any other right or remedy available
to CAT
it shall be entitled to charge Dyax interest (both before and
after judgment) of the amount unpaid at the annual rate of LIBOR
(London
Interbank Offering Rate) plus [*****] calculated on a daily basis
until
payment in full is made without prejudice to CAT's right to receive
payment on the due date.
|
|
8.1
|
With
respect to any confidential information received from the other
Party
("Confidential Information"), each Party
undertakes and agrees to:
|
|
|
(a)
|
only
use the Confidential Information for the purposes envisaged under
this
Agreement and not to use the same for any other purpose
whatsoever;
|
|
|
(b)
|
ensure
that only those of its officers and employees who are directly
concerned
with the carrying of this Agreement have access to the Confidential
Information on a strictly "need to know" basis and are informed
of the
secret and confidential nature of
it;
|
|
|
(c)
|
keep
the Confidential Information secret, confidential, safe and secure
and
shall not directly or indirectly disclose or permit to be disclosed
the
same to any Third Party, including any consultants or other advisors,
without the prior written consent of the disclosing Party except
to the
extent disclosure is necessary in connection with its use as envisaged
under this Agreement;
|
|
|
(d)
|
ensure
that the Confidential Information will not be covered by any lien
or other
encumbrance in any way, and
|
|
|
(e)
|
not
copy, reproduce or otherwise replicate for any purpose or in any
manner
whatsoever any documents containing the Confidential Information
except to
the extent necessary in connection with its use as envisaged under
this
Agreement.
|
For
the
avoidance of doubt, the Parties agree that the identity of the Target, any
information related to the Target provided to CAT by Dyax, and the Status
Report
is the Confidential Information of Dyax.
|
8.2
|
The
obligations referred to in Clause 8.1 above shall not extend to
any
Confidential Information which:
|
|
|
(a)
|
is
or becomes generally available to the public otherwise than be
reason of
breach by a recipient Party of the provision of Clause
8.1;
|
Schedule
7
- Page 11
|
|
(b)
|
is
known to the recipient Party and is at its free disposal (having
been
generated independently by the recipient Party or a Third Party
in
circumstances where it has not been derived directly or indirectly
from
the disclosing Party's Confidential Information prior to its receipt
from
the disclosing Party), provided that evidence of such knowledge
is
furnished by the recipient Party to the disclosing Party within
twenty-eight (28) days of recipient of that Confidential
Information;
|
|
|
(c)
|
is
subsequently disclosed to the recipient Party without obligations
of
confidence by a Third Party owing no such obligations to the disclosing
Party in respect of that Confidential
Information;
|
|
|
(d)
|
is
required by law to be disclosed (including as part of any regulatory
submission or approval process) and then only when prompt written
notice
of this requirement has been given to the disclosing Party so that
it may,
if so advised, seek appropriate relief to prevent such disclosure,
provided always that in such circumstances such disclosure shall
be only
to the extent so required and shall be subject to prior consultation
with
the disclosing Party with a view to agreeing on the timing and
content of
such disclosure.
|
|
8.3
|
No
public announcement or other disclosures to Third Parties concerning
the
terms of this Agreement shall be made, whether directly or indirectly,
by
either Party (except confidential disclosures to professional advisors)
without first obtaining the approval of the other Party and agreement
upon
the nature and text of such announcement or disclosure with the
exceptions
that:
|
|
|
(a)
|
a
Party may disclose those terms which it is required by regulation
or law
to disclose, provided that it takes advantage of all provisions
to keep
confidential as many terms of this Agreement as possible;
and
|
|
|
(b)
|
the
Party desiring to make any such public announcement or other disclosure
shall inform the other Party of the proposed announcement or disclosure
in
reasonably sufficient time prior to public release, and shall provide
the
other Party with a written copy thereof in order to allow such
Party to
comment upon such announcement or disclosure. Each Party agrees
that it shall cooperate fully with the other with respect to all
disclosures regarding this Agreement to the U.S. Securities Exchange
Commission, the UK Stock Exchange and any other comparable body
including
requests for confidential information or proprietary information
of either
Party included in any such
disclosure.
|
|
9.1
|
Dyax
hereby indemnifies CAT and its Affiliates and their directors,
officers,
employees and agents and their respective successors, heirs and
assigns
(the "CAT Indemnitees") against any liability, damage,
loss or expense (including attorneys fees and expenses of litigation)
incurred by or imposed upon the CAT Indemnitees or any one of them
in
connection with any claims, suits, actions, demands or judgments
by or in
favour of any Third Party concerning any manufacture, use or sale
of any
Product by Dyax or any Dyax Sublicensee (or their sublicensee).
In
addition, each Dyax Sublicensee (or their sublicensee) shall indemnify
the
CAT Indemnitees against any liability, damage, loss or expense
(including
attorneys fees and expenses of litigation) incurred by or imposed
upon the
CAT Indemnitees or any one of them in connection with any claims,
suits,
actions, demands or judgments by or in favour of any Third Party
concerning any manufacture, use or sale of any Product by such
Dyax
Sublicensee (or their sublicensee).
|
Schedule
7
- Page 12
|
9.2
|
CAT
shall not be liable to Dyax and Dyax Sublicensee (or its sublicensee)
in
respect of any liability, loss, damage or expense (including attorneys
fees and expenses of litigation) incurred or suffered by Dyax and
Dyax
Sublicensees (or its sublicensee) in connection with the manufacture,
use
or sale of any Products by Dyax and Dyax Sublicensees (or its
sublicensee).
|
|
9.3
|
CAT
gives no warranty or representation that the Antibody Phage Display
Patents are, or will be, valid or that the exercise of the rights
granted
under this Agreement will not result in the infringement of patents
of
Third Parties.
|
|
10.1
|
Dyax
shall notify CAT promptly of any proceedings or applications for
revocation of any of the Antibody Phage Display Patents emanating
from a
Third Party that comes to its notice or if a Third Party takes
or
threatens to take any proceedings for infringement of any patents
of that
Third Party by reason of Dyax's use or operation of the Antibody
Phage
Display Patents or manufacture, use or sale of the
Products. Dyax shall notify CAT promptly of any infringement of
the Antibody Phage Display Patents by a Third Party which may come
to its
attention during the term of the Dyax Product Licence, except Dyax
shall
have no obligation to so notify CAT with respect to any infringement
by an
academic or not-for-profit entity which occurs by reason of such
entity
carrying out research activities provided such activities are,
as far as
Dyax is aware, not being carried out with a view to commercialising
a
product or otherwise for profit.
|
|
10.2
|
CAT
shall have the sole right and responsibility, at its sole discretion
and
cost and with reasonable assistance from Dyax, to file, prosecute
and
maintain the Antibody Phage Display Patents and for the conduct
of any
lawsuits, claims or proceedings challenging the validity or enforceability
thereof including, without limitation, any interference or opposition
proceeding relating thereto in all countries. For the avoidance
of doubt, Dyax and Dyax Sublicensees will have the right to conduct
any
proceedings relating to its Product including any proceedings relating
to
product liability.
|
11. Termination
|
11.1
|
Unless
terminated under this Clause 11, this Agreement shall commence
on the
Commencement Date and shall terminate, on a country-by-country
and
Product-by-Product basis upon the last to expire of claims of an
issued
and unexpired patent within the Antibody Phage Display Patents
(which has
not been held permanently revoked, unenforceable or invalid by
a decision
of a court or other governmental agency of competent jurisdiction
unappealed within the time allowed for appeal, and which has not
been
admitted to be invalid or unenforceable through reissue or disclaimer
or
otherwise) or (b) the date upon which no payments are due to CAT
under
Clause 6 of this Agreement, whichever occurs
later.
|
Schedule
7
- Page 13
|
11.2
|
CAT
shall have the right to terminate this Agreement in the event
that:
|
|
|
11.2.1
|
Dyax
or a Dyax Sublicensee (or its sublicensee) has not filed an IND
for a
Therapeutic Antibody Product, or a 510(k) or IDE for a Diagnostic
Antibody
Product within [*****] after the Commencement Date; provided however,
that
Dyax shall have the right to extend such period in annual increments
by up
to [*****], upon the following
terms:
|
|
First
Annual Extension
|
$[*****]
|
|
Second
Annual Extension
|
$[*****]
|
In
order
for Dyax to be granted an extension under this Clause 11.2.1, the foregoing
amounts must be received by CAT prior to the date of expiration. All
amounts received by CAT under this Clause 11.2.1 will be credited against
any
milestones and royalties that would otherwise be due to CAT under the terms
of
the Product License; or
|
|
11.2.2
|
Dyax
or a Dyax Sublicensee (or its sublicensee) directly or indirectly
opposes
or assists any Third Party to oppose the grant of letters patent
or any
patent application within the Antibody Phage Display Patents, or
disputes
or directly or indirectly assists any Third Party to dispute the
validity
of any patent within the Antibody Phage Display Patents or any
of the
claims thereof.
|
|
11.3
|
In
the event that either Party commits a material breach of any of
its
material obligations with respect to this Agreement, and such Party
fails
to remedy that breach within ninety (90) days after receiving written
notice thereof from the other Party, that other Party may immediately
terminate this Agreement upon written notice to the breaching
Party.
|
|
11.4
|
Either
Party may terminate this Agreement in its entirety by giving notice
in
writing to the other Party if any one or more of the following
events
happens:
|
|
|
(a)
|
the
other Party has any distress or execution levied on the major portion
of
its assets (as determined by its balance sheet in accordance with
GAAP)
which is not paid out within thirty (30) days of its being
levied;
|
|
|
(b)
|
the
other Party calls a meeting for the purpose of passing a resolution
to
wind it up, or such a resolution is passed, or the other Party
presents,
or has presented, a petition for a winding up order, or presents,
or has
presented, a petition to appoint an administrator, or has an
administrative receiver, or receiver, liquidator or other insolvency
practitioner appointed over all or any substantial part of its
business,
undertaking, property or assets;
|
|
|
(c)
|
the
other Party stops or suspends making payments (whether of principal
or
interest) with respect to substantially all of its debts or announces
an
intention to do so or the other Party suspends or ceases to carry
on its
business;
|
|
|
(d)
|
a
secured lender to the other Party holding a security interest over
the
major portion of the tangible assets (as determined by its balance
sheet
in accordance with GAAP) of such other Party takes any steps to
obtain
possession of the property on which it has security or otherwise
to
enforce its security;
|
Schedule
7
- Page 14
|
|
(e)
|
the
other Party suffers or undergoes any procedure analogous to any
of those
specified in Clause 11.4(a)-(d) above or any other procedure available
in
the country in which the other Party is constituted, established
or
domiciled against or to an insolvent debtor or available to the
creditors
of such a debtor.
|
|
12.1
|
Upon
termination of this Agreement for any reason
whatsoever:
|
|
|
(a)
|
the
relationship of the Parties hereunder shall cease save as (and
to the
extent) expressly provided for in this Clause
12;
|
|
|
(b)
|
any
sublicenses granted by Dyax in accordance with the terms of this
Agreement
will continue in force provided that such sublicensees are not
in breach
of the relevant sublicense and that each sublicensee agrees to
enter into
a direct agreement with CAT upon the terms of this
Agreement;
|
|
|
(c)
|
Dyax
shall immediately return or procure to be returned to CAT at
such place as
it directs and at the expense of Dyax (or if CAT so requires
by notice to
Dyax in writing, destroy) all CAT Know-How together with all
copies of
such CAT Know-How in its possession or under its
control;
|
|
|
(d)
|
The
following provisions shall survive expiration or termination
of this
Agreement: Clauses 7 (in relation to any accrued payment obligations
of
Dyax prior to termination or expiry), 8, 9, 12, 13 and 15;
and
|
|
|
(e)
|
Expiry
or termination of this Agreement shall not affect the rights
and
obligations of the Parties accrued prior to such expiry or termination
including any accrued obligation for Dyax to make any payments
under
Clause 6.
|
|
13.1
|
Any
dispute arising between the Parties relating to, arising out
of or in any
way connected with this Agreement or any term or condition thereof,
or the
performance by either Party of its obligations hereunder, whether
before
or after termination of this Agreement, shall be referred to
the Chief
Executive Officers of each of the Parties. The Chief Executive
Officers shall meet to resolve such deadlock within thirty (30)
days of
the date that the dispute is referred to them, at a time and
place
mutually acceptable to them. Any dispute that has not been
resolved following good faith negotiations of the Chief Executive
Officers
for a period of thirty (30) days shall be referred to and finally
settled
by binding arbitration in accordance with the then current Commercial
Arbitration Rules of the American Arbitration
Association. There shall be three (3) arbitrators, each Party
to designate one arbitrator and the two Party-designated arbitrators
to
select the third arbitrator. The Party initiating recourse to
arbitration shall include in its notice of arbitration its appointment
of
an arbitrator. The appointing authority, in the event a Party
does not or the Parties do not appoint arbitrator(s), shall be
the
American Arbitration Association in [*****]. The place of
arbitration shall be [*****]. The language to be used in the
arbitration
shall be English. Any determination by the arbitration panel
shall be final and conclusively binding. Judgement on any
arbitration award may be entered in any court having jurisdiction
thereof. Each Party shall bear its own costs and expenses
incurred in the arbitration; provided that the arbitration panel
may
assess the costs and expenses of the prevailing Party, including
reasonable attorneys fees, against the non-prevailing
Party.
|
Schedule
7
- Page 15
14. Notices
|
14.1
|
All
notices, requests, demands and other communications required or
permitted
to be given pursuant to this Agreement shall be in writing and
shall be
deemed to have been duly given upon the date of receipt if delivered
by
hand, recognized international overnight courier, confirmed facsimile
transmission, or registered or certified mail, return receipt requested,
postage prepaid to the following addresses or facsimile
numbers:
|
|
If
to Dyax:
|
If
to CAT:
|
|
|
Cambridge
Antibody Technology Limited
|
||
|
▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
|
The
▇▇▇▇▇▇▇▇ Building
|
|
|
Cambridge,
MA 02139
|
Granta
Park, Cambridge
|
|
|
Attention: Chief
Executive Officer
|
▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇
|
|
|
Facsimile: (▇▇▇)
▇▇▇-▇▇▇▇
|
United
Kingdom
|
|
|
Attention: Company
Secretary
|
Facsimile: ▇▇▇-▇▇-(▇)▇▇▇▇
▇▇▇▇▇▇
|
Either
party may change its designated address and facsimile number by notice to
the
other party in the manner provided in this Clause.
15. Governing
Law
|
15.1
|
This
Agreement shall be governed by and construed in accordance with
the laws
of the [*****].
|
|
15.2
|
Save
as provided in this Clause, the United Kingdom Legislation entitled
the
Contracts (Rights of Third Parties) Act 1999 will not apply to
this
Agreement. No person, other than a CAT Indemnitee (as defined
in Clause 9.1), who is not a Party to this Agreement (including
any
employee, officer, agent, representative or subcontractor of either
Party)
will have the right (whether under the Contracts (Rights of Third
Parties)
▇▇▇ ▇▇▇▇ or otherwise) to enforce any term of this Agreement which
expressly or by implication confers a benefit on that person without
the
express prior agreement in writing of the Parties which agreement
must
refer to this Clause, except that any Dyax Sublicensee shall have
the
right to enforce the provisions of Clause 12.1(b) of this Agreement
and
shall be a third party beneficiary for that purpose
only.
|
Schedule
7
- Page 16
|
16.1
|
The
parties agree that irreparable damage will occur in the event that
the
provisions of Clause 8 are not specifically enforced. In the
event of a breach or threatened breach of any such provisions,
each Party
agrees that the other Party shall, in addition to all other remedies,
be
entitled to temporary or permanent injunction, without showing
any actual
damage or that monetary damages would not provide an adequate remedy
and
without the necessity of posting any bond, and/or a decree for
specific
performance, in accordance with the provisions
hereof.
|
17. Assignment
|
17.1
|
This
Agreement may not be assigned by either party without the prior
written
consent of the other party, except that either Party may assign
the
benefit and/or burden of this Agreement to any Affiliate of it
or any
Third Party, provided that such Affiliate or Third Party undertakes
to the
other Party to be bound by the terms of this Agreement. This Agreement
shall inure to the benefit of and be binding upon the parties and
their
respective lawful successors and
assigns.
|
|
18.1
|
Nothing
in this Agreement shall be construed so as to require the commission
of
any act contrary to law, and wherever there is any conflict between
any
provision of this Agreement and any statute, law, ordinance, or
treaty,
the latter shall prevail, but in, such event the affected provisions
of
the Agreement shall be conformed and limited only to the extent
necessary
to bring it within the applicable legal
requirements.
|
|
19.1
|
This
Agreement may be amended, supplemented, or otherwise modified only
by
means of a written instrument signed by both parties. Any
waiver of any rights or failure to act in a specific instance shall
relate
only to such instance and shall not be construed as an agreement
to waive
any rights or fail to act in any other instance, whether or not
similar.
|
20. Severabi1ity
|
20.1
|
In
the event that any provision of this Agreement shall, for any reason,
be
held to be invalid or unenforceable in any respect, such invalidity
or
unenforceability shall not affect any other provision hereof and
the
parties shall negotiate in good faith to modify the Agreement to
preserve
(to the extent possible) their original
intent.
|
21. Entire
Agreement
|
21.1
|
This
Agreement and the Amendment Agreement constitute the entire agreement
between the parties with respect to the subject matter hereof and
supersede all prior agreements or understandings between the parties
relating to the subject matter
hereof.
|
Schedule
7
- Page 17
|
SIGNED
by
|
|
|
| ▇▇▇▇▇▇ ▇▇▇▇ |
)
|
|
| General Counsel |
)
|
/s/
▇▇▇▇▇▇
▇▇▇▇
|
|
for
and on behalf of
|
)
|
Authorised
Signatory
|
|
CAMBRIDGE
ANTIBODY
|
)
|
|
|
TECHNOLOGY
LIMITED
|
)
|
|
|
SIGNED
by
|
)
|
|
|
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇
General
Counsel and
Executive
Vice President of Administration
|
)
)
)
|
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇▇ |
|
for
and on behalf of
|
)
|
Authorised
Signatory
|
| ) |
|
|
|
|
)
|
|
|
)
|
||
Schedule
7
- Page 18
Schedule
8
[RESERVED]
Schedule
9-A
[*****]
Schedule
9-A - Page 1
Schedule
9-B
[*****]
Schedule
9-B - Page 1
Schedule
9-C
[*****]
Schedule
9-C - Page 1
Schedule
9-D
[*****]
Schedule
9-D - Page 1
Schedule
9-E
[*****]
Schedule
9-E - Page 1
Schedule
10-A
CAT
hereby
acknowledges and agrees that the Affimed Sublicense granted to CAT under
Section
11.2(a) is subject to the following terms and conditions:
(a) Nothing
in this Agreement shall be deemed to grant CAT rights under the Affimed Patent
Rights broader than the field and scope of the license granted to Dyax under
the
Affimed License; and nothing in this Agreement shall be deemed to grant CAT
the
right to (i) make, sell, offer for sale or import any composition of matter
other than Products which would, but for the licenses granted herein, infringe
a
Valid Claim of the Affimed Patent Rights, or (ii) use any phage or phagemid
library other than the Dyax Antibody Library;
(b) The
Affimed Sublicense shall be subject to the applicable terms and conditions
of
the Affimed License;
(c) CAT
agrees that, promptly after execution of this Agreement, Dyax shall deliver
to
Affimed only those relevant portions of this Agreement evidencing the sublicense
granted hereunder is in compliance with the terms and conditions set forth
in
the Affimed License;
(d) In
the event that the Affimed License is terminated prior to its expiration
for any
reason, the Affimed Sublicense shall terminate; and
(e) If
CAT fails to comply with any terms and conditions set forth herein, the Affimed
Sublicense shall automatically terminate.
Schedule
10-A - Page 1
Schedule
10-B
CAT
hereby
acknowledges and agrees that the Biosite Sublicense granted to CAT under
Section
11.2(b) is subject to the following terms and conditions:
(a) CAT
shall comply with the restrictions imposed by Biosite on any potential
sublicensee under Section 2.2 of the Biosite License;
(b) Nothing
in this Biosite Sublicense shall be deemed to grant CAT rights under the
Biosite
Patent Rights and Biosite Know-How Rights broader than the rights granted
to the
Dyax Antibody Library and the Dyax Patent Rights under this Agreement and
such
rights to the Biosite Patent Rights and Biosite Know-How are limited to use
with
the Dyax Antibody Library and Antibody Compounds as permitted by Clause 11.1
of
the Agreement;
(c) CAT
and its Affiliates shall not enforce (or attempt or purport to enforce) against
Biosite or its Affiliates any patent that claims (or purports to claim) any
process of, any composition for or any use of (i) Biosite Know-How Rights,
provided that such Biosite Know-How Rights have been disclosed to CAT by
Dyax,
(ii) creating, constructing or producing immune libraries from immunized
rodents
for the purpose of phage display therefrom of antibodies or binding fragments
thereof, or (iii) phage display of antibodies or binding fragments thereof,
or
(iv) selecting or producing antibodies or binding fragments thereof derived
from
such libraries. The Biosite Sublicense shall automatically terminate
upon any breach of this covenant, which shall survive any termination of
the
Biosite Sublicense;
(d) A
signed copy of this Biosite Sublicense (with any provisions of the
Agreement reasonably deemed necessary by Dyax
and Biosite) shall be provided to Biosite in order to confirm that Dyax has
complied with Biosite’s restrictions on granting sublicenses contained in the
Biosite License;
(e) In
the event that the Biosite License be terminated early, the Biosite Sublicense
shall also terminate; and
(f) The
Biosite Sublicense shall not become effective until all of the conditions
of
this Schedule 10-B have been met.
The
parties expressly acknowledge that the term of the Biosite Sublicense shall
be
coextensive with the term of the Agreement; provided, however,
that the Biosite Sublicense is subject to early termination, upon written
notice
by Dyax to CAT, if the Biosite License terminates early for any
reason.
Schedule
10-B - Page 1
Schedule
10-C
CAT
hereby
acknowledges and agrees that the Domantis Sublicense granted to CAT under
Section 11.2(c) is subject to the following terms and conditions:
(a)
Nothing in this Agreement shall be deemed to grant CAT rights under the Domantis
Patent Rights broader than the field and scope of the license granted to
Dyax
under the Domantis License; and nothing in this Agreement shall be deemed
to
grant CAT the right to (i) make, sell, offer for sale or import any composition
of matter other than Products which would, but for the licenses granted herein,
infringe a Valid Claim of the Domantis Patent Rights, or (ii) use any phage
or
phagemid library other than the Dyax Antibody Library; and
(b)
CAT agrees that, promptly after execution of
this Agreement, Dyax shall have the right to notify Domantis of this Agreement
in compliance with the terms and conditions set forth in the Domantis
License.
Schedule
10-C - Page 1
Schedule
10-D
CAT
hereby
acknowledges and agrees that the Genentech Sublicense granted to CAT under
Section 11.2(d) is subject to the following terms and conditions:
(a) CAT
shall comply with the restrictions imposed by Genentech on any potential
Genentech Sublicensee under Section 2.3 of the Genentech License;
(b) Nothing
in the Genentech Sublicense shall be deemed to grant CAT rights under the
Genentech Patent Rights broader than the rights granted to the Dyax Antibody
Library and the Dyax Patent Rights under the Agreement and such rights to
the
Genentech Patent Rights are limited to use with the Dyax Antibody Library
and
Antibody Compounds as permitted under Clause 11.1 of the Agreement;
(c) A
signed copy of this Genentech Sublicense (with any provisions of the Agreement
reasonably deemed necessary by Dyax and Genentech) shall be provided to
Genentech in order to confirm that Dyax has complied with Genentech’s
restrictions on granting sublicenses contained in the Genentech
License;
(d) In
the event that the Genentech License is terminated early, the Genentech
Sublicense shall also terminate; and
(e) The
Genentech Sublicense shall not become effective until all of the conditions
of
this Schedule 10-D have been met.
The
parties expressly acknowledge that the term of the Genentech Sublicense shall
be
coextensive with the term of the Agreement; provided, however,
that the Genentech Sublicense is subject to early termination, upon written
notice by Dyax to CAT, if the Genentech License terminates early for any
reason.
Schedule
10-D - Page 1
Schedule
10-E
As
required by the XOMA Agreement, CAT acknowledge and agree that the XOMA Covenant
is subject to the following provisions:
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(a)
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shall
not extend to the use of the XOMA Expression Technology to make
any amount
of a Licensed Immunoglobulin or Product other than Research Quantities;
provided, however, that this limitation shall not preclude the
manufacture, in commercial quantities, of a Licensed Immunoglobulin
discovered using the XOMA Expression Technology in accordance with
this
Agreement when produced in a production system other than a
prokaryot;
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(b)
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CAT
agrees that the "first sale" doctrine does not apply to any Disposition
of
Transferred Materials;
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(c)
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CAT
shall Dispose of Transferred Materials only to a Third Party who
otherwise
meets the definition of a Dyax Collaborator under the XOMA Agreement
and
who executes a written agreement in which its undertakes all of
the
obligations set forth herein, provided, however, that
this Section (c) shall not apply to the Disposition of any Licensed
Immunoglobulin hereunder ;
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(d)
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If
CAT or any person or entity controlled by CAT contests the validity
or
enforceability of any of the XOMA Patent Rights hereunder, XOMA
shall have
the right to terminate (or cause Dyax to terminate) all of the
rights
hereby granted to CAT under the XOMA Patent
Rights;
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(e)
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CAT
acknowledges and agrees that nothing in this Agreement or this
Schedule
10-E shall be construed as a release or waiver of past, present
or future
infringement of the XOMA Patent Rights by CAT acting outside the
scope of
this Agreement nor as a release from Dyax from any claim of infringement
of the XOMA Patent Rights nor as any right to release any Third
Party from
any claim of infringement under the XOMA Patent
Rights;
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(f)
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CAT
acknowledges and agrees that the XOMA Covenant shall not extend
to
infringement of the XOMA Patent Rights arising out of making or
the means
or methods used to make any amount of a Licensed Antibody or Product
other
than those quantities of Antibody reasonably required for Research
and
Development purposes; provided, however, that Dyax or CAT shall
be permitted to make or have made any Licensed Antibody by any
means of
its selection other than those which otherwise infringe a Valid
Claim of
the XOMA Patent Rights;
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(g)
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CAT
acknowledges and agrees that the XOMA Covenant shall become void
and
without effect as to CAT if CAT fails to materially discharge or
comply
with any terms of this Agreement with respect to the XOMA Patent
Rights;
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(h)
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CAT
acknowledges and agrees that the XOMA Covenant is personal to Dyax
and CAT
and cannot be assigned or
transferred;
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Schedule
10-E - Page 1
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(i)
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CAT
agrees that Dyax shall have the right to deliver to XOMA a written
report
which shall specify the name, address and contact person for CAT;
and
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(j)
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In
the event of the termination of the XOMA Agreement by Dyax, the
licenses
and rights granted to Dyax and CAT under the XOMA Agreement shall
survive. In the event of the termination of the XOMA Agreement
by XOMA, the licenses and rights granted to Dyax and CAT under
the XOMA
Agreement shall terminate; and
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(k)
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XOMA
shall be an intended third party beneficiary with respect to the
foregoing
provisions..
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CAT
and
Dyax agree that capitalized terms used in this Schedule 10-E that are not
defined in the Agreement shall have the meanings given to them under the
XOMA
Agreement.
Schedule
10-E - Page 2