Exhibit 10.2
COLLABORATION AND LICENSE AGREEMENT
THIS AGREEMENT (this "Agreement"), effective as of October 31,
2000 (the "Effective Date"), is between DYAX CORP., a Delaware corporation,
having a principal place of business at One Kendall Square, Bldg. 600,
Cambridge, Massachusetts 02139 ("Dyax"); and BRACCO HOLDING, B.V., a Netherlands
corporation, having its principal place of business at Strawinskylaan 3051, 1077
ZX Amsterdam, and BRACCO INTERNATIONAL, B.V., a Netherlands corporation, having
its principal place of business at Strawinskylaan 3051, 1077 ZX Amsterdam
("Bracco"). The parties hereby agree as follows:
RECITALS
WHEREAS, Dyax possesses intellectual property, display
technology and expertise relating to the discovery of proteins, peptides and
antibodies and other compounds having novel binding properties for therapeutic,
diagnostic and other uses;
WHEREAS, Bracco possesses intellectual property, technology
and expertise relating to the research, development and commercialization of
diagnostic imaging products and radiopharmaceuticals;
WHEREAS, the parties wish to collaborate and cooperate using
their respective technologies and expertise to discover and develop product
candidates for use in diagnostic imaging and certain therapeutic fields under
the terms and conditions hereof.
NOW, THEREFORE, in consideration of the foregoing and the
covenants and premises contained in this Agreement, the parties hereto hereby
agree as follows:
ARTICLE 1. DEFINITIONS
For purposes of this Agreement, the terms defined in this Article shall have the
meanings specified below. These terms are intended to encompass both the
singular and plural forms.
1.1. "Affiliate" shall mean a corporation or other legal entity that
controls, is controlled by, or is under common control with such party. For
purposes of this definition, "control" 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.
1.2. "Bracco" shall mean Bracco identified as a party above and any
Affiliate.
1.3. "Bracco Carrier" shall mean any chelates for radiodiagnostic
metals (such as (99m)Tc), chelates for radiotherapeutic metals (such as
(90Y)) and ultrasound gas vesicles, lipid
CONFIDENTIAL - DYAX CORP.
vesicles and liposomes, polymer capsules and particles that are proprietary to
Bracco and associated Patent Rights, representative examples of which are set
forth in Attachment A.
1.4. "Bracco Imaging Chelate" shall mean the proprietary chelates of
Bracco and associated Patent Rights to which Dyax will be granted a license to
use in accordance with Section 4.8b and any Bracco Improvements.
1.5. "Bracco Improvements" shall mean any improvements to any Bracco
Carrier, including to any Bracco Imaging Chelate made by Bracco or Dyax at any
time during the term of this Agreement and any Patent Rights covering any
inventions resulting from such improvements.
1.6. "Bracco Leads" shall mean any peptide, protein or antibody
molecule and the sequence contained therein and derivatives thereof discovered
by Bracco after the Research Term using any of the Dyax Technology or Dyax
Improvements and associated Patent Rights.
1.7. "Bracco Net Revenues" shall mean all payments received by Bracco
from any third party, (other than a distributor with whom Bracco has a normal
distribution agreement in effect i.e. Bracco BykGulden and Bracco Eisai),
whether cash or other consideration, from the license or sublicense of a
Licensed Product, less any payments made to reimburse Bracco for actual costs
incurred.
1.8. "Bracco Net Sales" shall mean the amounts invoiced on the sales of
each Licensed Product by Bracco and its distributors to independent, unrelated
third parties in bona fide arms' length transactions, less the following
deductions properly documented actually allowed and taken by such third parties:
(a) trade, cash and quantity discounts, including charge backs; (b) taxes on
sales (such as sales or use taxes) to the extent added to the sales price and
set forth separately as such in the total amount invoiced; (c) freight,
insurance and other transportation charges to the extent added to the sales
prices and set forth separately as such in the total amount invoiced; (d)
amounts repaid or credited by reason of rejections, defects or returns, or
because of retroactive price reductions, or due to governmental laws or
regulations requiring rebates; (e) import duties.
1.9. "Bracco Project" shall mean any project commenced by Bracco after
the Research Term using Dyax Technology or Dyax Leads.
1.10. "Bracco Therapeutics Field" shall mean IN VIVO treatment of human
disease either by (a) radiotherapy that uses a targeting agent to deliver a
radioactive isotope coupled with a Bracco Carrier or (b) by targeted delivery of
a drug (other than one arising out of a Dyax Lead, Collaboration Lead or Bracco
Lead) that incorporates a Bracco Carrier.
1.11. "Collaboration" shall mean any research, development or other
activities conducted by Dyax during the Research Term pursuant to any
Collaboration Project and any research, development, commercialization,
marketing or other activities conducted by Bracco during or after the Research
Term pursuant to a Collaboration Project.
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1.12. "Collaboration Field" shall mean collectively the Diagnostic
Imaging Field and the Bracco Therapeutics Field.
1.13. "Collaboration Leads" shall mean any peptide, protein or antibody
molecule and the sequence contained therein and derivatives thereof, resulting
from or pertaining to any Collaboration Project commenced during the Research
Term and that exist at the time of termination of the Research Term and
associated Patent Rights, other than Dyax Leads.
1.14. "Collaboration Project" shall mean any project approved as such
by the Steering Committee during the Research Term.
1.15. "Competing Product" shall mean any product in the Diagnostic
Imaging Field that, if developed, is intended to detect the same disease or
condition in the same patient population as: (i) a then existing commercial
Bracco product in the Diagnostic Imaging Field, or (ii) a Bracco product in the
Diagnostic Imaging Field that is under Formal Development, either within or
outside of the Collaboration, or under a Bracco Project, or with a third party,
or (iii) a product in the Diagnostic Imaging Field arising from a Collaboration
Project.
1.16. "Collaboration Results" shall mean any Collaboration Leads and
other materials, information, data, and know-how, whether or not patentable,
that result from any Collaboration Project that is useful by Bracco in the
Collaboration Field or by Dyax in all fields except the Collaboration Field, and
any Patent Rights covering inventions resulting from such Collaboration Project,
excluding Dyax Technology and Dyax Improvements and Barriers Carrier and Bracco
Improvements.
1.17. "Confidential Information" shall mean any scientific, technical,
trade or business information which is disclosed verbally, in writing or other
tangible form by one party to the other party and is identified as confidential
at the time of disclosure. "Confidential Information" does not include
information which (a) was known to the receiving party at the time it was
disclosed, other than by previous disclosure by the disclosing party, as
evidenced by written records at the time of disclosure: (b) at the time of
disclosure or later becomes publicly known under circumstances involving no
breach of this Agreement; (c) is lawfully and in good faith made available to
the receiving party by a third party who did not derive it from the disclosing
party and who imposes no obligation of confidence on the receiving party; (d) is
developed by the receiving party independent of any disclosure by the disclosing
party, as evidenced by the receiving party's written records; or (e) is required
by law or regulation to be disclosed.
1.18. "Diagnostic Imaging Field" shall mean any IN VIVO use in medical
imaging, including radiopharmaceutical, ultrasound, MRI and X ray and light
imaging.
1.19. "Dyax" shall mean Dyax identified as a party above and any
Affiliate.
1.20. "Dyax Chelated Product" shall mean a Dyax product that was
developed using any Bracco Imaging Chelate for which Dyax is obligated to pay
Bracco royalties in connection with the license to the Bracco Imaging Chelates
granted in Sections 4.8b.
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1.21. "Dyax Improvements" shall mean any improvement to the Dyax
Technology made by Dyax during the Research Term or by Bracco at any time during
the Collaboration or when Bracco is licensed to use the Dyax Technology, *****
1.22. "Dyax Leads" shall mean any peptide, protein or antibody
molecules existing as of the Effective Date as set forth in Attachment B and any
peptide, protein or antibody molecules that Dyax thereafter owns or controls and
has the right to grant licenses in the Diagnostic Imaging Field after the
Effective Date for so long as Bracco maintains the exclusive license to the Dyax
Technology in the Diagnostic Imaging Field pursuant to Section 4.1a; and any
data, know-how, inventions and Patent Rights pertaining to such Dyax Leads. Dyax
Leads shall not include any Collaboration Leads. All derivatives of Dyax Leads
whether derived, generated or discovered by Dyax or Bracco shall be deemed Dyax
Leads for purposes of this definition. During the Collaboration period,
Attachment B, from time to time but at least quarterly will be updated to
include any new Dyax Lead.
1.23. "Dyax Net Sales" shall mean the amounts invoiced on the sales of
each Dyax Chelated Product by Dyax its licensees, sublicensees and distributors
to independent, unrelated third parties in bona fide arms' length transactions,
less the following deductions properly documented actually allowed and taken by
such third parties: (a) trade, cash and quantity discounts, including charge
backs; (b) taxes on sales (such as sales or use taxes) to the extent added to
the sales price and set forth separately as such in the total amount invoiced;
(c) freight, insurance and other transportation charges to the extent added to
the sales prices and set forth separately as such in the total amount invoiced;
(d) amounts repaid or credited by reason of rejections, defects or returns, or
because of retroactive price reductions, or due to governmental laws or
regulations requiring rebates; (e) import duties;
1.24. "Dyax Technology" shall mean collectively any proprietary
peptide, protein and antibody library technology and/or all related materials,
data, know-how, inventions and Patent Rights that Dyax owns or controls and has
the right to grant licenses to in the Diagnostic Imaging Field existing or
arising during and through the Research Term.
1.25. "Existing Agreements" shall mean any agreement as well as signed
term sheet between Dyax and a third party whose effects apply also to the
Diagnostic Imaging Field existing as of the Effective Date, a list of which is
attached as Schedule C.
1.26. "Formal Development" shall mean the formal management decision by
Bracco, its licensees or sublicensees to advance one or more Dyax Leads,
Collaboration Leads or Bracco Leads for the same Target or another Target within
the same Collaboration Project or within the same Bracco Project in a single
licensed field to human testing.
1.27. "Licensed Product" shall mean any product that consists of,
includes or was derived from any Dyax Lead, Collaboration Lead or Bracco Lead
for which Formal Development has commenced or which arose out of a Collaboration
Project pursuant to Section 4.4.
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1.28. "Other Therapeutics Field" shall mean all human therapeutic and
prophylactic uses, excluding the Bracco Therapeutics Field.
1.29. "Patent Rights" shall mean patent applications or patents, author
certificates, inventor certificates, utility certificates, improvement patents,
and models and certificates of addition, and all foreign counterparts of them
and includes divisions, renewals, continuations, continuations-in-part,
extensions, reissues, substitutions, confirmations, registrations,
revalidations, or additions of or to them as well as any supplementary
protection certificate or any other post patent expiration extension of patent
protection in respect to them.
1.30. "Research Term" shall mean the term during which Dyax performs
funded research for Bracco that begins on the Effective Date and will end in
accordance with Section 12.1.
1.31. "Target" shall mean a biological entity to which the Dyax
Technology is applied with the aim of obtaining a Dyax Lead, Collaboration Lead
or Bracco Lead.
ARTICLE 2. SCOPE AND MANAGEMENT OF THE COLLABORATION
2.1. Scope of Collaboration.
a. Goals of the Collaboration. The purpose of the
Collaboration is to use the Dyax Technology to advance the discovery,
development and commercialization of Dyax Leads and Collaboration Leads in the
Diagnostic Imaging Field which will be accomplished through Collaboration
Projects that will be submitted by the parties either jointly or individually to
the Steering Committee during the Research Term for consideration and approval.
After the Research Term expires, the Collaboration will continue with the
Collaboration Projects and Bracco may use Collaboration Projects to advance the
discovery, development and commercialization of Collaboration Leads and Dyax
Leads in the Diagnostic Imaging Field. To further the purpose of the
Collaboration, the parties have established the following Collaboration Goals:
*****
b. Collaboration Projects. Each Collaboration Project will
involve specific Targets that must be approved by the Steering Committee. If
Bracco has selected a Target for the Diagnostic Imaging Field, Dyax may only
withhold approval for the Diagnostic Imaging Field if Dyax is prevented by an
Existing Agreement from using Dyax Technology. With respect to the Bracco
Therapeutics Field, Dyax may only withhold approval if Dyax has a program in the
Other Therapeutics Field, or if any third party rights arising from an Existing
Agreement limit the use of the Target in the Bracco Therapeutic Field. Once a
Target has been identified, it shall be the responsibility of the Steering
Committee to determine the details of each Collaboration Project, to cause
appropriate intellectual property searches to be conducted with regard to the
applicable Targets, and to conduct or cause others to conduct appropriate
evaluations to determine the technical and commercial feasibility of each
Collaboration Project. During the Research Term, Dyax and Bracco, either
together or individually, will seek to
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identify Collaboration Leads to the Target. The parties will then continue to
use Collaboration Projects to develop, evaluate and advance Collaboration Leads
and Licensed Products.
c. Dyax Role during the Research Term. During the Research
Term, Dyax will assign a ***** Dyax full time equivalent employees ("FTE"s)
(including space and material supplies for such FTEs) to provide research and
technology transfer in connection with Collaboration Projects. The parties
envision that the Dyax FTEs will be used in Collaboration Projects during the
Research Term: (1) to optimize and develop Dyax Leads; (2) to screen the Dyax
libraries to identify and optimize Collaboration Leads for IN VIVO diagnostic
Targets; (3) to build and screen custom libraries as may be necessary; (4) to
provide training and assistance to designated Bracco scientists on the use of
Dyax Technology; (5) to extend work on Dyax Leads or Collaboration Leads to the
Bracco Therapeutics Field in accordance with any extension of Bracco's license
rights. At any time during the Research Term with 90 days notice to Dyax, Bracco
may request that Dyax increase the number of assigned Dyax FTEs. During the
Research Term, any research and development performed by Dyax using the Dyax
FTEs shall be conducted as part of a Collaboration Project.
d. The Collaboration after the Research Term. After the
Research Term expires, for so long as the licenses in Section 4.1 remain in
effect, and subject to the requirements of Section 5.1, 5.2 and 5.3, Bracco will
continue to advance the discovery, development and commercialization of the
Collaboration Projects. After the Research Term expires, the Steering Committee
will continue to oversee Collaboration Projects, will administer the carve out
provisions for Dyax Leads and Collaboration Leads as set forth in Sections 5.2
and 5.3, administer other contract provisions and coordinate intellectual
property matters.
e. Bracco Reporting Obligations for Collaboration Projects.
During and after the Research Term expires, Bracco shall provide Dyax through
the Steering Committee with detailed written reports on a quarterly basis of its
development and commercialization efforts which shall include the description of
the activities performed and the amounts invested by Bracco in each
Collaboration Project.
f. After Formal Development. Once Formal Development begins,
Bracco will continue to provide the Steering Committee with detailed written
reports on a quarterly basis of its development and commercialization efforts
with regard to any Licensed Products; provided, however, Bracco will be solely
and exclusively responsible for decision making concerning the development and
commercialization of such Licensed Products.
2.2. The Steering Committee. This Collaboration shall be managed by a
Steering Committee, which shall be composed of two (2) representatives appointed
by Dyax and two (2) representatives appointed by Bracco. Such representatives
will be senior managers of their respective companies. The Steering Committee
shall hold its first meeting within 30 days of the Effective Date and will
thereafter meet as needed but not less than once each calendar quarter. Such
meetings shall be at times and places or in such form (e.g., telephone or video
conference) as the members of the Steering Committee shall agree. A party may
change one or more of its
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representatives to the Steering Committee at any time. Members of the Steering
Committee may be represented at any meeting by another member of the Steering
Committee or by a deputy. Representatives of either Dyax and Bracco who are not
members of the Steering Committee may attend meetings of the Steering Committee
as agreed to by the representative members of the other party. At or before the
commencement of each meeting, the Steering Committee shall appoint one of its
members to act as secretary for such meeting or shall arrange for a person to be
present in such capacity. The Steering Committee shall keep accurate minutes of
its deliberations and shall record all proposed decisions and all actions
recommended or taken. The person acting as the secretary shall be responsible
for the preparation of draft minutes. Draft minutes shall be sent to all members
of the Steering Committee within ten (10) working days after each meeting and
shall be approved, if appropriate, at the next meeting. All records of the
Steering Committee shall at all times be available to both parties.
2.3. Functions of the Steering Committee.
a. The Steering Committee shall perform the following
functions: (i) determine the overall strategy for the Collaboration in the
manner contemplated by this Agreement and the scope of the Collaboration as set
forth in Section 2.1 hereof (ii) consider, review and approve Collaboration
Projects acceptable to Bracco (c) oversee the use of the Dyax assigned staff
(FTEs) and coordinate the activities of the parties hereunder (d) settle
disputes or disagreements that are unresolved with the Collaboration Leaders or
any Collaboration Project Team; and (e) and perform such other functions as
appropriate to further the purposes of this Agreement and the scope of the
Collaboration.
b. Bracco and Dyax both recognize that in the spirit of making
the Collaboration successful, the Steering Committee shall attempt to make all
approvals, determinations and other actions by unanimous consent of the members
of the Steering Committee and the parties will use reasonable efforts to reach
such unanimous consent. *****
2.4. Collaboration Leaders and Collaboration Project Teams. Each party
shall appoint a Collaboration Leader to oversee all of the Collaboration
Projects. The Dyax Collaboration Leader shall be responsible for coordinating
the assigned Dyax FTEs during the Research Term and monitoring the compliance
with the indications, guidance and direction provided for by the Steering
Committee. At least once a month, the Collaboration Leaders shall meet in person
or by conference call to discuss the progress made with respect to each of the
Collaboration Projects. During the Research Term, each Collaboration Project
shall have a Collaboration Project Team appointed by the Collaboration Leaders
in consultation with the Steering Committee. The Collaboration Project Team for
each Collaboration Project shall prepare a work plan for the Collaboration
Project, which shall be presented to the Steering Committee through the
Collaboration Leaders. The Collaboration Leaders may appoint a Project Manager
for any Collaboration Project who shall be part of the Collaboration Project
Team. For each Collaboration Project started during the Research Term, within
thirty (30) days following the end of each calendar quarter, the Collaboration
Project Team shall provide the Collaboration Leaders with a reasonably detailed
written report describing the progress to date of the Collaboration
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Project and shall update the work plan. The progress reports and updated work
plans shall be submitted to the Steering Committee. After the Research Term
expires, the Collaboration Leaders will continue to meet monthly to discuss the
progress of any Collaboration Projects.
2.5 Technology Transfer. During the Research Term, Dyax shall transfer
to Bracco mutually agreed upon Dyax Technology and shall provide Bracco with
training on the use of the Dyax Technology at agreed upon dates and locations.
Dyax libraries shall be provided as sample aliquots sufficient for several
screens and for Bracco to amplify such aliquots to make further samples. The
time involved for training and the preparation of any Dyax Technology for
transfer in accordance with this Section 2.5 shall be part of the FTEs assigned
to Bracco.
ARTICLE 3. SCOPE AND MANAGEMENT OF BRACCO PROJECTS
3.1. Bracco Projects while Bracco is Dyax's Exclusive Licensee in the
Diagnostic Imaging Field.
a. After the Research Term, should Bracco wish to perform any
research and development using the Dyax Technology that is unrelated to a
Collaboration Project, while the exclusive license rights to the Dyax Technology
and the Dyax Leads in the Diagnostic Imaging Field granted in Section 4.1 remain
in effect, Bracco shall do so pursuant to Bracco Projects. Bracco shall also use
Bracco Projects to advance the discovery, development and commercialization of
Dyax Leads or Bracco Leads in the Diagnostic Imaging Field .
b. Prior to commencing a Bracco Project, Bracco shall first
seek approval from Dyax of the applicable Targets which approval may only be
withheld for the Diagnostic Imaging Field if Dyax is prevented by an Existing
Agreement from using Dyax Technology as provided in Section 2.1b. After Target
approval, Bracco will provide the Steering Committee with a reasonable detailed
description of the Bracco Project, including an outline of the development plan,
an estimate of the investments contemplated and the timing envisioned for
starting Formal Development. Bracco will continue to keep the Steering Committee
informed in writing on a quarterly basis on the progress of each Bracco Project
and shall keep the Steering Committee updated with regard to the development and
commercialization of Bracco Leads and of any Dyax Leads.
c. After Formal Development. Once Formal Development begins,
Bracco will continue to provide the Steering Committee with detailed written
reports on a quarterly basis of its development and commercialization efforts
with regard to any Licensed Products; provided, however, Bracco will be solely
and exclusively responsible for decision making concerning the development and
commercialization of such Licensed Products.
3.2. Bracco Projects Should Bracco's License in the Diagnostic Imaging
Field Become Non-Exclusive. Should Bracco's license rights to the Dyax
Technology in the Diagnostic Imaging Field become non-exclusive, to the extent
Bracco continues to use the Dyax Technology, Bracco shall do so pursuant to a
Bracco Project for which Bracco will provide written reports to the Steering
Committee on a quarterly basis as to the progress of each Bracco Project and the
status of the advancement, research, discovery and commercialization of Bracco
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Leads or for any Dyax Leads which were part of a Bracco Project commenced during
exclusivity.
ARTICLE 4. LICENSE GRANTS AND OPTIONS
4.1. Licenses in the Diagnostic Imaging Field.
a. License to Dyax Technology. Subject to Section 4.6, Dyax
hereby grants to Bracco an exclusive worldwide license to use the Dyax
Technology and Dyax Improvements pursuant to a Collaboration Project and/or a
Bracco Project to research, develop, make and use Dyax Leads, Collaboration
Leads and Bracco Leads in the Diagnostic Imaging Field and to use in connection
with the applicable Collaboration Project and/or Bracco Project the Dyax
Technology, Dyax Improvements and Collaboration Results to research, develop and
make Licensed Products in the Diagnostic Imaging Field from such Dyax Leads,
Collaboration Leads and Bracco Leads. Bracco may not sublicense the license
rights granted herein to the Dyax Technology and Dyax Improvements. The licenses
granted to Bracco in Section 4.1 to the Dyax Technology in the Diagnostic
Imaging Field shall be exclusive during the Research Term and thereafter so long
as Bracco meets the exclusivity maintenance requirement set forth in Section
6.2.
b. Bracco acknowledges the possible limitations on the license
rights granted herein as provided for the in the Existing Agreements.
c. License to Dyax Leads, Collaboration Leads and Bracco
Leads. Subject to Section 4.6, Dyax grants to Bracco an exclusive worldwide
license, with the right to grant sublicenses, to use the Dyax Leads,
Collaboration Leads and Bracco Leads and Collaboration Results pursuant to a
Collaboration Project or a Bracco Project to research, develop, make, have made,
use, import and have sold Licensed Products in the Diagnostic Imaging Field.
4.2. Option in the Bracco Therapeutics Field.
a. License Option. With regard to any Dyax Lead for which a
Collaboration Project exists and for any Collaboration Lead or Bracco Lead,
Bracco may extend the license rights granted pursuant to paragraph 4.1 to the
exclusive use of such lead to research, develop, make, have made, use, import
and have sold Licensed Products in the Bracco Therapeutics Field and will have a
non-exclusive license to use the Dyax Technology in the Bracco Therapeutics
Field in connection therewith; provided that such lead is not part of an active
Dyax research and development program or that Dyax is not precluded from
granting the license because of an agreement with a third party.
b. Exercise of Option. Bracco shall request to exercise the
option set forth in paragraph a. of this Section 4.2, by providing written
notice to the Steering Committee and to Dyax of the Dyax Lead, Collaboration
Lead or Bracco Lead for which it seeks to exercise the option, including with
such notice, a plan for the commercial development of such lead in the Bracco
Therapeutics Field which plan, if the license is granted by Dyax, shall become
part of the existing Collaboration Project pertaining to such lead. Within 30
days of receipt of Bracco's
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notice, the Steering Committee will meet to consider Bracco's request. Within 30
days of the meeting, Dyax shall provide a written response to Bracco, which will
either include a grant by Dyax to Bracco of exclusive license rights to such
Dyax Lead, Collaboration Lead or Bracco Lead and the specific Collaboration
Results pertaining to such lead to research, develop, make, have made, use,
import and have sold Licensed Products in the Bracco Therapeutics Field for the
milestones and royalties payments set forth in Section 6.5 hereof, or designate
the Dyax research and development program or agreement (within the bounds of any
Dyax confidentiality obligations) that precludes the granting of the license to
Bracco. The license shall only become effective upon receipt of the written
grant by Dyax. A list of the Dyax Leads that are currently part of a research
and development program or an agreement covering therapeutics are set forth on
Attachment C. Dyax will update the list and provide a copy to the Steering
Committee from time to time upon the Steering Committee's request.
4.3. Other Therapeutics Field License Option. For so long as the
licenses to the Collaboration Lead or Bracco Lead granted to Bracco in Section
4.1 in the Diagnostic Imaging Field remain exclusive, Bracco shall have an
option to obtain a license from Dyax to the exclusive use of such Collaboration
Lead or Bracco Lead in the Other Therapeutics Field, unless Dyax is precluded
from granting the license by an agreement existing or in negotiation with a
third party at the time that Bracco seeks to exercise the option. This option
shall be in effect for a period of ***** from the date the Steering Committee
first approves the applicable Collaboration Project in the case of a
Collaboration Lead and for a period of ***** from the date of Bracco's
submission to the Steering Committee of the Bracco Project that gave rise to the
applicable Bracco Lead. Bracco may seek to exercise its option at any time
before the expiration of the ***** option period. Bracco may exercise the option
by giving written notice to Dyax and the Steering Committee within the
applicable ***** time period, designating in such notice whether Bracco would
prefer a worldwide license or a license for a specified geographical region,
such as Europe. Within 30 days of receipt of Bracco's notice, the Steering
Committee will meet to consider Bracco's request. Within 30 days of the meeting,
Dyax will respond in writing to Bracco. The response shall include a grant of
exclusive license rights from Dyax to Bracco to such Collaboration Lead or
Bracco Lead, as the case may be, to research, develop, make, have made, use,
import and have sold Licensed Products in the Other Therapeutics Field for the
milestones and royalties payments set forth in Section 6.6, hereof or designate
the agreement that precludes the granting of the license to Bracco. The response
shall also designate whether the license will be worldwide or for a specified
geographical region, should Dyax determine in its discretion that it wishes to
retain any geographical rights. The license shall only become effective upon
written grant by Dyax and payment by Bracco of $***** for worldwide rights or
$***** per region for regional rights (Europe being a single region).
4.4. Dyax Third Party Collaborators.
a. For so long as the licenses granted to Bracco in Section
4.1 in the Diagnostic Imaging Field remain exclusive, should a collaborator or a
prospective third party collaborator of Dyax (other than Human Genome Sciences,
Inc.) request a license to use any of the Dyax Technology for IN VIVO diagnostic
uses of a target that are necessary for the successful
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commercialization of a therapeutic or prophylactic product that is for the same
target in the Other Therapeutics Field, Dyax shall bring such request to the
attention of the Steering Committee which shall convene a meeting within 30 days
of the request to determine the suitability of the proposed third party use as a
Collaboration Project intended to lead to a Licensed Product. Prior to the
Steering Committee meeting, appropriate representatives of the parties shall
discuss the prospective Collaboration Project with the third party and with each
other for the purposes of assisting the Steering Committee in its determination.
Within 30 days of the Steering Committee meeting, Bracco shall notify the
Steering Committee if it wishes to enter into a Collaboration Project for the
proposed third party use. Should Bracco not wish to enter into such a
Collaboration Project, notwithstanding the licenses set forth in Section 4.1,
Dyax may use the Dyax Technology to provide the IN VIVO diagnostic use
contemplated by the proposed Collaboration Project to the third party or grant
the third party an appropriate license to the Dyax Technology for such in vivo
diagnostic use provided that such use will not involve a Competing Product.
4.5. Notification Rights in the Other Therapeutics Field. For so long
as the exclusivity remains in full force, should Dyax decide to outlicense the
development and/or marketing rights in the Other Therapeutic Field to any Dyax
Lead during the Research Term or to any Collaboration Lead or Bracco Lead *****
has expired, and Dyax is not otherwise precluded by an another agreement from
entering into an outlicense with Bracco, Dyax shall notify Bracco of its
intention to outlicense. Bracco shall respond to Dyax's notice within 30 days
indicating to Dyax whether or not Bracco would like the opportunity to negotiate
an outlicense with Dyax for the development and/or marketing rights for such
lead. The selection of the party with whom Dyax ultimately chooses to enter into
such an outlicense in the Other Therapeutics Field shall be Dyax's.
4.6. Limitation of Rights.
a. Exclusive License to Dyax Technology During the Research
Term. Bracco shall maintain an exclusive license to the Dyax Technology in the
Diagnostic Imaging Field during the Research Term for so long as Bracco complies
at all times with the diligence provisions set forth in Section 5.1a., Section
5.2, Section 5.3 and in Section 5.4 to the extent Bracco has obtained any
therapeutic rights.
b. Exclusive License to Dyax Technology after the Research
Term. Bracco shall maintain an exclusive license to the Dyax Technology in the
Diagnostic Imaging Field after the Research Term for so long as Bracco meets the
exclusivity maintenance requirements of Section 6.2, as well as the diligence
requirements set forth in Section 5.1b.
c. Non-Exclusive License to Dyax Technology after the Research
Term. After the Research Term, should Bracco not meet the exclusivity
maintenance requirement, the license to the Dyax Technology in the Diagnostic
Imaging Field granted in Section 4.1 shall become non-exclusive.
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d. Rights to the Leads. Should the license to the Dyax
Technology become non-exclusive, the license to the Dyax Leads in the Diagnostic
Imaging Field granted in Section 4.1 for which no Collaboration Project exists
shall terminate. The license granted in Section 4.1 to the Collaboration Leads,
Bracco Leads and Dyax Leads for which a Collaboration Project exists in the
Diagnostic Imaging Field and the license to the specific Collaboration Results
pertaining to such Collaboration Leads shall remain exclusive in the Diagnostic
Imaging Field, subject to the provisions of Section 5.2 and 5.3 for Dyax Leads
and Collaboration Leads. Any license that has been granted to Bracco to the
exclusive use of a Collaboration Lead, Bracco Lead or Dyax Lead in the Bracco
Therapeutics Field pursuant to Section 4.2 shall also remain exclusive, subject
to the requirements of Section 5.4 and any license that has been granted to
Bracco to the exclusive use of a Collaboration Lead or a Bracco Lead in the
Other Therapeutics Field pursuant to Section 4.3 shall remain exclusive, subject
to the requirements of Section 5.4.
e. Each party agrees that, except as set forth in this
Agreement, no other rights or licenses are granted to any patents, patent
applications, inventions, trademarks, trade secrets or other intellectual
property, or to any materials, information, data or know-how, of the other
party.
4.7. Covenant Not to Sue. Bracco agrees not to enforce against Dyax any
Patent Rights owned or controlled by Bracco that arose or will arise from
Bracco's use of any of the Dyax Technology or any of the inventions therein,
that Dyax may infringe in practicing the Dyax Technology or the inventions
claimed therein. Nothing in this Section 4.7 is intended to grant Dyax any
rights to nonsuit with respect to any claim in any Patent Right owned or
controlled by Bracco that claims any Licensed Product. The parties agree that
the covenant not to sue in this Section 4.7 is an obligation that transfers with
the sale or disposition by Bracco of the applicable patent right.
4.8. Licenses from Bracco to Dyax.
a. Collaboration Results. Subject to the option rights of
Bracco with regard to the Other Therapeutic Field as set forth in Section 4.3,
Bracco grants to Dyax an exclusive worldwide license, with the right to
sublicense, to the Collaboration Results generated by Bracco for all uses
outside of the Collaboration Field. Should Dyax obtain rights with regard to any
Dyax Lead in the Diagnostic Imaging Field pursuant to Section 5.2 or to any Dyax
Lead or Collaboration Lead in the Collaboration Field pursuant Section 5.3, Dyax
shall have an exclusive worldwide license, with the right to sublicense, to the
specific Collaboration Results pertaining to the applicable Collaboration Lead
and a nonexclusive worldwide license, with the right to sublicense, to use the
generally useful Collaboration Results in connection therewith. Dyax's rights to
the Collaboration Lead and the Collaboration Results in the Collaboration Field
shall be subject to the diligence requirements of Section 5.5.
b. Bracco Imaging Chelates and Bracco Improvements. To the
extent that Dyax obtains the rights to any Bracco Imaging Chelates and Bracco
Improvements pursuant to Sections 5.2a. and 5.3, Dyax shall have an exclusive
license, with the right to sublicense, to use the Bracco Imaging Chelates and
Bracco Improvements in connection with the applicable Dyax Lead or Collaboration
Lead for the applicable Collaboration Field to research, develop, make,
12
have made, use, import and have sold Dyax Chelated Products. Dyax's rights to
Bracco Imaging Chelates and Bracco Improvements for the Collaboration Leads in
the Collaboration Field shall be subject to the diligence requirements of
Section 5.5.
ARTICLE 5. DILIGENCE REQUIREMENTS
5.1. a. Bracco General Diligence Requirements for Collaboration
Projects. Bracco shall use commercially reasonable efforts (1) to broadly and
diligently exploit the Dyax Technology in the Diagnostic Imaging Field and (2)
broadly and diligently develop and commercialize each Dyax Lead and each
Collaboration Lead for which it has obtained a license in the Bracco
Therapeutics Field or the Other Therapeutics Field pursuant to Sections 4.2 or
4.3. Bracco shall keep Dyax through the Steering Committee properly up-to-date
and apprised on the status of each Collaboration Project by providing the
Steering Committee with detailed written reports on a quarterly basis in
accordance with Section 2.1 above.
b. Bracco General Diligence Requirements for Bracco Projects
during the Dyax Technology exclusivity period. (i) Bracco shall use commercially
reasonable efforts to diligently exploit the Dyax Technology in the Diagnostic
Imaging Field. Bracco shall keep Dyax through the Steering Committee properly
up-to-date and apprised on the status of each Bracco Project by providing the
Steering Committee with detailed written reports on a quarterly basis in
accordance with Section 2.1 above. (ii) saved what is set forth in the previous
paragraph 5.1 b (i), Bracco is under no obligation to advance, develop and
generate Bracco Leads and the carve out provisions set forth in this Article 5
will not apply to Bracco Leads.
5.2. Bracco Specific Diligence Requirements for Dyax Leads.
a. Existing Dyax Leads for ***** . Bracco's diligence
requirements shall include the evaluation of the existing Dyax Leads *****.
Within 30 days of the Effective Date, Bracco shall provide to Dyax a proposed
schedule for the evaluation of each such Dyax Lead for finalization and approval
as a Collaboration Project at the initial meeting of the Steering Committee. At
the conclusion of Bracco's evaluation, Dyax will have the exclusive right to
each such Dyax Lead in the Diagnostic Imaging Field that Bracco chooses not to
develop. Dyax shall exercise such right by giving written notice to the Steering
Committee for each such Dyax Lead that Dyax wishes to develop. In connection
with each such Dyax Lead, Dyax shall also have the right to utilize the
applicable Bracco Imaging Chelates in the Diagnostic Imaging Field which right
it shall seek to request in its notice to the Steering Committee. Such right to
use the Bracco Imaging Chelates shall be ***** unless at the time of such
request involves a Competing Product. Bracco shall provide a written response to
the Steering Committee within 30 days of receipt of Dyax's request to use the
Bracco Imaging Chelates. Such response shall either verify that the license to
such Bracco Imaging Chelates is ***** or shall identify Bracco's competing
product. Should Dyax wish to use the Bracco Imaging Chelates where there is a
competing Bracco product, Dyax shall so notify Bracco and ***** as set forth in
Section 6.8 in connection with any Dyax Chelated Product.
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b. Dyax Leads. During the Research Term and so long as the
license rights to the Dyax Technology in the Diagnostic Imaging Field remain
exclusive, Dyax or Bracco as the case may be through the Steering Committee may
propose to the Steering Committee for its evaluation of Dyax Leads. The Steering
Committee within the following 60 days shall complete the analysis and
evaluation of such Dyax Lead and determine whether the proposed Dyax Lead, if
during the Research Term is worth being advanced into a Collaboration Project
or, if afterwards, into a Bracco Project. If the Steering Committee determines
that the Dyax Lead is not worth generating either a Collaboration Project or a
Bracco Project, and provided that the Dyax Lead does not involve a Competing
Product, Dyax shall have the right to develop such Dyax Lead pursuant to the
procedure set forth in the following paragraph 5.2c.
c. Carve Out for Dyax Leads. For so long as the licenses
granted to Bracco in Section 4.1 in the Diagnostic Imaging Field remain
exclusive, if at any time Dyax wishes to develop any of the Dyax Leads that are
not being developed by Bracco through any Collaboration Project or a Bracco
Project, Dyax may so notify the Steering Committee, identifying in such
notification the specific Dyax Lead it wishes to develop and indicating its
intention to diligently pursue the development of such Dyax Lead in the
Diagnostic Imaging Field. Bracco shall have a period of 60 days from Dyax's
notice to determine whether it wishes to go forward with the development of the
Dyax Lead through a Collaboration Project or a Bracco Project. If Bracco
determines that it does wish to go forward, it shall so inform the Steering
Committee and Bracco shall have an additional 30 days to present a Collaboration
Project or a Bracco Project to the Steering Committee concerning such Dyax Lead.
If Bracco does not wish to develop the Dyax Lead, Bracco's rights with regard to
the specific Dyax Lead shall terminate so that Dyax may develop such Dyax Lead
in the Diagnostic Imaging Field.
5.3. Bracco's Specific Diligence Requirements for Collaboration Leads
and Dyax Leads in the: Carve Out. With regard to Collaboration Leads and Dyax
Leads in any Collaboration Project or Bracco Project, Bracco shall maintain an
exclusive license in the Collaboration Field for so long as an active
Collaboration Project or Bracco Project exists for such Collaboration Leads or
Dyax Leads. A Collaboration Project or Bracco Project shall be deemed active
provided that Bracco funds the Collaboration Project or Bracco Project in a
total amount equal to or greater than $***** during each consecutive *****
period following the commencement date of such Collaboration Project or Bracco
Project. If during any ***** period, Bracco's total funding including Bracco
expenses and any payment to Dyax pursuant to Section 6.3, for any Collaboration
Project or Bracco Project goes below $*****, but not less than $*****, Bracco
may reserve such Collaboration Project or Bracco Project as one for which the
licenses granted hereunder remain exclusive in the Collaboration Field, provided
Bracco may not reserve any more than a total of ***** Collaboration Projects and
Bracco Projects at any one time. With regard to any Collaboration Projects or
Bracco Projects for which Bracco provides funding in an amount less than $*****
period, Dyax shall have the right to request that Bracco increase its investment
to make the Collaboration Project or Bracco Project active or in reserve (if the
permitted number in reserve has not been exceeded). Should Bracco fail to
provide the Steering Committee with confirmation of its intention to increase
the investments for such Collaboration Project or Bracco Project within 3 months
from Dyax's request, Dyax may submit
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a proposed plan to Bracco for the development by Dyax of any such Collaboration
Leads or Dyax Leads in the Collaboration Project or Bracco Project. As long as
Dyax indicates in its proposed plan that it intends to allocate at least an
amount equal to or greater than ***** then Dyax shall have the exclusive right
to advance the development of such Collaboration Leads or Dyax Leads. In no
event shall Dyax use the Collaboration Leads or Dyax Leads to develop a
Competing Product. With regard to the Bracco Therapeutics Field, if Bracco is
diligently pursuing a Collaboration Lead or Dyax Lead for a specific Target,
Dyax will not pursue any other Collaboration Lead or Dyax Lead for the same
Target if by doing so, Dyax would be competing with another then existing Bracco
product or a product that Bracco has in development. For such Collaboration
Leads and Dyax Leads for which Dyax has the exclusive rights under this
paragraph, Dyax shall also have the right to use the Bracco Imaging Chelates
subject to payment of royalties to Bracco on Bracco Imaging Chelate Products as
set forth in Section 6.8.
5.4. Specific Diligence Requirements to Maintain Therapeutic Rights. In
order to maintain the therapeutic rights that Bracco may have obtained with
regard to a Collaboration Lead or Dyax Lead or Bracco Lead pursuant to Section
4.2 or a Collaboration or a Bracco Lead pursuant to Section 4.3, Bracco shall
initiate Formal Development for the lead in the applicable therapeutics field
within ***** of the of the effective date of the Collaboration Project or Bracco
Project giving rise to such lead and shall thereafter spend no less than $*****
in connection with the commercial development of such lead until the first
commercial sale of a Licensed Product based on such lead.
5.5. Dyax Diligence Requirements. Dyax agrees to use commercially
reasonable and diligent efforts to perform the research and development that is
specifically allocated to Dyax under each Collaboration Project. Dyax will
assign personnel with appropriate experience for the work that Dyax is required
to perform during each such Collaboration Project. To the extent that Dyax
obtains the rights to develop any Collaboration Leads in the Collaboration Field
pursuant to Section 5.3, Dyax shall broadly and diligently develop and
commercialize such Collaboration Leads. Dyax shall provide Bracco, through the
Steering Committee, with detailed written reports on a quarterly basis of its
development and commercialization efforts which shall include development and
commercialization plans and the amounts spent on activities in connection with
each Collaboration Lead.
ARTICLE 6. PAYMENTS AND ROYALTIES
6.1. License Fee. In consideration of the exclusive licenses rights
granted to the Dyax Technology, Dyax Leads, Collaboration Leads and
Collaboration Results in the Diagnostic Imaging Field in Section 4.1 hereunder ,
Bracco will pay to Dyax within ten (10) days of the Effective Date three million
U.S. dollars ($3,000,000).
6.2. Exclusivity fee after the expiration of the Research Term. To
preserve the exclusivity of the licenses granted pursuant to Section 4.1a., to
the Dyax Technology and Dyax
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Improvements after the Research Term expires in accordance with Section 12.1,
Bracco shall make annual payments to Dyax on the anniversary of the completion
of the Research Term. An initial payment of $***** shall be due on the first
anniversary. In each successive year, the annual payment shall increase by the
amount of $*****, subject to a maximum annual payment of $*****. *****
6.3. Research Payments. During the Research Term, Bracco shall make
quarterly research payments to Dyax with an annual minimum of $3,000,000. Such
payments shall be based on the number of FTEs assigned to Bracco, at the rate of
$***** per year for each of the first ***** FTEs assigned to Bracco, and $*****
per year for any FTE assigned above the first *****. Payments shall be due
within sixty (60) days of receipt of an invoice from Dyax showing the number of
FTEs assigned to Bracco during the previous quarter. In addition, Bracco shall
reimburse Dyax for any mutually agreed upon out-of-pocket external expenses
incurred during the Research Term. Dyax shall maintain records of the FTEs
assigned to Bracco and shall require the FTEs to report on an ongoing basis the
results of their work.
6.4. Diagnostic Imaging Products. For each Licensed Product in the
Diagnostic Imaging Field, Bracco shall pay to Dyax the following milestone and
royalty payments:
a. ***** at the start of Formal Development. Bracco to pay
such milestone only once if multiple Dyax Leads, Collaboration Leads or Bracco
Leads for the same Target are advanced in the Diagnostic Imaging Field;
b. ***** upon the start of the first Phase III clinical trial;
c. ***** upon the first NDA/BLA filing in either the United
States, any country in Europe, or Japan;
d. ***** upon the first marketing approval in either the
United States, any country in Europe, or Japan; and
e. For all indications of each Licensed Product sold in the
Diagnostic Imaging Field, a royalty of ***** on the first $***** of annual
Bracco Net Sales, of ***** on annual Bracco Net Sales of over $***** up to
$*****, and ***** on annual Bracco Net Sales of over $*****. For Licensed
Product, and *****, Bracco may deduct $***** due under this paragraph e.
6.5. Bracco Therapeutic Products. For each Licensed Product in the
Bracco Therapeutic Field, Bracco shall pay to Dyax the following milestone and
royalty payments.
a. ***** at the start of Formal Development. Bracco to pay
such milestone only once if multiple leads for the same target are advanced in
the Bracco Therapeutic Field;
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b. ***** upon the start of the first Phase III clinical trial
for such Licensed Product;
c. ***** upon the first NDA/BLA filing in either the United
States, any country in Europe, or Japan;
d. ***** upon the first marketing approval in either the
United States, any country in Europe, or Japan; and
e. For all indications of each Licensed Product sold in the
Bracco Therapeutics Field, a royalty of ***** on the first $***** of annual
Bracco Net Sales, ***** on all annual Bracco Net Sales of over $***** up to
$*****, and ***** on all annual Bracco Net Sales of over $*****.
6.6. Other Therapeutic Products. For each Licensed Product in the Other
Therapeutics Field, Bracco shall pay to Dyax the following milestone and royalty
payments:
a. ***** at the start of Formal Development. Bracco to pay
such milestone only once if multiple leads are advanced for the same target in
the Other Therapeutic Field;
b. ***** upon the start of the first Phase III clinical trial
c. ***** upon the first NDA/BLA filing in either the United
States, any country in Europe, or Japan;
d. ***** upon the first marketing approval in either the
United States, any country in Europe, or Japan; and
e. For all indications of each Licensed Product sold in the
Other Therapeutic Field, a royalty of ***** on annual Bracco Net Sales.
6.7. Bracco Net Revenues in Lieu of Milestones and Royalties. If Bracco
outlicenses any Licensed Product to a third party (other than a distributor with
whom Bracco has a normal distribution agreement in effect), Bracco shall pay to
Dyax, in lieu of milestones and royalties set forth in Sections 6.4, 6.5 and
6.6, the following:
(1) ***** of all Bracco Net Revenues
received from such outlicense, if the product is outlicensed
prior to payment of the milestone owed pursuant to paragraph
b. of Sections 6.4, 6.5 and 6.6;
(2) ***** of all Bracco Net Revenues
received from such outlicense, if the product is outlicensed
after payment of the milestone owed pursuant to paragraph b.,
but prior to payment of the milestone owed pursuant to
paragraph d. of Sections 6.4, 6.5 and 6.6; and
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(3) ***** of all Bracco Net Revenues
received from such outlicense, if the product is outlicensed
after payment of the milestone owed pursuant to paragraph d.
of Sections 6.4, 6.5 and 6.6.
6.8. Dyax Chelated Products. For each Dyax Chelated Product that was
derived from a Dyax Lead ***** for each Dyax Chelated Product in the
Collaboration Field that was derived from a Collaboration Lead or Dyax Lead
for which Dyax is obligated to pay royalties pursuant to Section 5.3, Dyax
shall pay Bracco a royalty of ***** on the first $***** of annual Dyax Net
Sales, ***** on annual Dyax Net Sales of over $*****, and ***** on annual
Dyax Net Sales of over $*****.
6.9. Permitted Offsets. In the event that Bracco is required to pay
royalties on Bracco Net Sales on any Licensed Product or Dyax is required to pay
royalties on Dyax Net Sales on any Dyax Chelated Product to a third party as a
result of any patent license required for Bracco to make, use or sell such
Licensed Product or for Dyax to make, use or sell such Dyax Chelated Product,
Bracco or Dyax, as the case may be, shall be permitted to offset such royalty
payment against the royalty payments due Dyax on the same Bracco Net Sales or
Bracco on the same Dyax Net Sales, provided, however, that any offset shall be
applied on a pro rata basis with any offsets permitted by the third party, and
provided further that in no event shall any royalty payment due Dyax on the same
Bracco Net Sales or Bracco on the same Dyax Net Sales ever be reduced by more
than ***** or be lower than ***** of Bracco Net Sales or Dyax Net Sales, as the
case may be.
6.10. Term of Royalty and Revenue Obligations. The royalty and revenue
obligations with respect to Licensed Products and Dyax Chelated Products, shall
terminate on a country-by-country basis and on a product by product basis ten
(10) years after the first country-wide launch of such product in such country
6.11. Specific Definitions. For purposes of this Article 6, "BLA" shall
mean a Biological License Application as defined in the U.S. Food, Drug and
Cosmetic Act and the regulations promulgated thereunder, as amended, and any
filing under any successor laws and regulations or its foreign equivalent, "NDA"
shall mean a New Drug Application as defined in the U.S. Food, Drug and Cosmetic
Act and the regulations thereunder, as amended or its foreign equivalent, and
"Phase III clinical trial" shall mean a human clinical trial in any country the
results of which could be used as pivotal to establish safety and efficacy of a
product as a basis for a marketing approval application submitted to the FDA or
the appropriate regulatory authority of such other country, or that would
otherwise satisfy the requirements of 21 CFR 312.21(c); and (b) a trial shall be
"started" upon the enrollment of the first patient for such trial. If the nature
of a trial earlier than Phase III is not determined to be pivotal until after
completion of the trial, then any milestone payment that would have been due
upon start of a Phase III trial shall be due upon submission of the trial in
support of the filing of an application for marketing approval in the United
States, Europe or Japan.
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ARTICLE 7. STATEMENTS AND REMITTANCES
7.1. Milestone and Royalty Payments. All milestone payments pursuant to
Sections 6.3, 6.4 and 6.5 shall be due and payable within thirty (30) days after
the applicable milestone event is achieved by or on behalf of Bracco. Commencing
with the first commercial sale of a Licensed Product or a Dyax Chelated Product
in any country, within 45 days after the conclusion of each calendar quarter,
Bracco or Dyax, as the case may be, shall deliver to the other party a report
containing the following information, on a country-by-country basis: Gross
receipts of Licensed Products or Dyax Chelated Products in each country;
calculation of Bracco Net Sales (or Bracco Net Revenues in the case of an
outlicense) or Dyax Net Sales, together with the exchange rates used for
conversion; and calculation of the amount payable to Dyax or Bracco for the
applicable calendar quarter. Payment shall be made contemporaneously with each
report. If no royalties or other payments are due for any reporting period, the
report shall so state.
7.2. Records. Each party shall maintain, and shall ensure that its
distributors, licensees or sublicensees shall maintain, complete and accurate
records of Licensed Products or Dyax Chelated Products made, used, or sold
under this Agreement and any amounts payable to Dyax in relation to such
Licensed Products or to Bracco in relation to such Dyax Chelated Products,
which records shall contain sufficient information allow confirmation of the
accuracy of any reports delivered to the other party in accordance with
Section 7.1. Each party shall retain such records relating to a given
calendar quarter for at least 3 years after the conclusion of that quarter.
The receiving party shall have the right, at its expense, to cause an
independent certified public accountant to inspect such records during normal
business hours for the sole purpose of verifying any reports and payments
delivered to it by the reporting party under this Agreement. The parties
shall reconcile any underpayment or overpayment within 30 days after the
accountant delivers the results of the audit. In the event that any audit
performed under this Section reveals an underpayment in excess of ***** for
any audited period, the reporting party shall bear the full cost of such
audit.
7.3. Terms of Payments. All payments specified under this Agreement
shall be considered non-refundable and shall be made without deduction of
exchange, collection, or other charges. All payments shall be made in United
States dollars. Conversion of foreign currency to U.S. dollars shall be made at
the conversion rate existing in the United States (as reported in the Wall
Street Journal) on the last working day of the calendar quarter preceding the
applicable calendar quarter. If The Wall Street Journal ceases to be published,
then the rate of exchange to be used shall be that reported in such other
business publication of national circulation in the United States as the parties
reasonably agree. Each party shall deduct any taxes which the party is obligated
to pay and/or withhold in a country based on royalties due to the other based on
sales in such country from royalty payments due for such country under this
Agreement and pay them to the proper authorities as required by applicable laws.
Each party shall maintain official receipts of payment of any such taxes and
forward these receipts to the other within sixty (60) days and shall provide
reasonable assistance to the other party in obtaining any credit or refund of
such taxes.
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7.4. Late Payments. Any payments that are not paid on or before the
date that such payments are due under this Agreement shall bear interest, to
the extent permitted by law, at ***** most recently reported by The Wall
Street Journal *****. If The Wall Street Journal ceases to be published, then
***** to be used shall be that reported in such other business publication of
national circulation in the United States as the parties reasonably agree.
This Section 7.4 shall in no way limit any other remedies available to a
party.
ARTICLE 8. INTELLECTUAL PROPERTY RIGHTS AND PATENTING OF INVENTIONS
8.1. Ownership. Dyax shall retain ownership of all Dyax Technology and
Dyax Improvements made by Dyax or Bracco, all Dyax Leads, Collaboration Leads
and Bracco Leads and of all other Collaboration Results that are generated
solely by Dyax during the Research Term. Bracco shall own all materials and
technology it provides to Dyax for use during the Research Term, all Bracco
Carriers and Bracco Improvements, and all Collaboration Results that are
generated solely by Bracco, other than Collaboration Leads and the results of
any Bracco Projects other than Bracco Leads, for which Bracco will have the
licenses and rights set forth in Article 4 of this Agreement. Bracco shall
provide Dyax with access to any Dyax Improvements made by Bracco and shall
furnish such Dyax Improvements to Dyax upon request. Dyax shall provide Bracco
with any Bracco Improvements made by Dyax and shall furnish such Bracco
Improvements to Bracco upon request. Bracco shall own any of its Licensed
Products and Dyax shall own any of its Dyax Chelated Products. To the extent
that any invention arising out of this Agreement does not pertain to a Dyax
Lead, Collaboration Lead or Bracco Lead, or to the Dyax Technology or Dyax
Improvements or the Bracco Carriers or Bracco Improvements and is not clearly
owned solely by one party, the parties shall jointly own such inventions ("Joint
Inventions"). For so long as the exclusive licenses to Bracco to the Dyax
Technology and Dyax Improvements in the Diagnostic Imaging Field remains in
effect, Bracco shall have an exclusive license to use such Joint Inventions in
the Collaboration Field. Dyax shall have an exclusive license to use such Joint
Inventions in all fields accept the Collaboration Field. Should the licenses to
Bracco to the Dyax Technology and Dyax Improvements become non-exclusive, each
party shall have a non-exclusive license, with the right to sublicense, to use
the Joint Inventions in the Collaboration Field.
8.2. Patenting Inventions.
a. Allocation of Responsibility for Patent Rights. Dyax shall
be responsible for the filing, prosecution and maintenance and costs of all
patent applications and patents which make up the Patent Rights pertaining to
Dyax Technology, Dyax Improvements and Dyax Leads and Bracco shall be
responsible for the filing, prosecution and maintenance and costs of all patent
applications and patents which make up the Patent Rights to the Bracco Carriers,
the Bracco Improvements and the Licensed Products. For any patentable invention
arising from this Agreement that is a method or composition of matter relating
to any Collaboration Lead or Bracco Lead, the parties, through the Steering
Committee, shall agree upon filing for,
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maintaining, defending and enforcing patent applications and patents which make
up the applicable Patent Rights, with the costs to be shared as determined by
the Steering Committee. For all other patentable inventions pertaining to the
Collaboration Results, each party shall be responsible for decisions and costs
related to filing for, maintaining, defending and enforcing patent applications
and patents which make up the Patent Rights for solely owned inventions and the
parties shall have joint responsibility, through the Steering Committee, for the
Patent Rights pertaining to the Joint Inventions. The parties acknowledge and
agree that the party with the most knowledge and expertise in the subject matter
of the Joint Invention shall be primarily responsible for the filing,
prosecution and maintenance of the patent applications and patents which make up
the Patent Rights for such Joint Inventions with the full cooperation and
assistance of the other party and the costs to be borne as determined by the
Steering Committee. Should a Joint Invention be outside of either party's core
technology area or expertise, the parties shall negotiate in good faith through
the Steering Committee the relative contributions of each party and the process
for filing, prosecuting and maintaining patent applications and patents which
make up the Patent Rights pertaining to such Joint Inventions.
b. Cooperation and Assistance with Patent Rights. Each of Dyax
and Bracco shall consult with and keep the other fully informed of important
issues relating to the preparation and filing (if time permits), prosecution and
maintenance of such patent applications and patents pertaining to the Patent
Rights arising out of this Agreement for which it is responsible, and shall
furnish to the other party copies of documents relevant to such preparation,
filing, prosecution or maintenance in sufficient time prior to filing such
document or making any payment due thereunder to allow for review and comment by
the other party and, to the extent possible in the reasonable exercise of its
discretion, the filing party shall incorporate all such comments. Each of Dyax
and Bracco shall make available to the other party (or to the other party's
authorized attorneys, agents or representatives) its employees, agents or
consultants to the extent necessary or appropriate to enable the appropriate
party to file, prosecute and maintain patent applications and resulting patents
with respect to inventions owned by a party and for periods of time sufficient
for such party to obtain the assistance it needs from such personnel. Where
appropriate, each of Dyax and Bracco shall sign or cause to have signed all
documents relating to said patent applications or patents at no charge to the
other party.
8.3. Enforcement of Patent Rights; Defense of Infringement. Dyax and
Bracco shall each promptly notify the other in writing of any alleged or
threatened infringement of any patents or patent applications for which it is
responsible pursuant to Section 8.2 above or if either party shall be
individually named as a defendant in a legal proceeding by a third party for
infringement of a patent because of the manufacture, use or sale of a Licensed
Product or a Dyax Chelated Product or because of attempts to invalidate Patent
Rights pertaining thereto. Dyax shall have the sole right to respond to or
defend against a challenge or infringement of its Patent Rights pertaining to
any Dyax Technology, Dyax Improvements or Dyax Leads and Bracco shall have the
sole right to respond to or defend against a challenge or infringement of its
Patent Rights pertaining to any Bracco Carriers or Bracco Improvements. Each of
Dyax and Bracco shall have the first right to respond to or defend (in
consultation with the Steering Committee) against a challenge or infringement of
the Patent Rights pertaining to any Collaboration Lead or Bracco Lead for which
it is responsible pursuant to Section 8.2 above or charge of infringement. Such
right shall be exercised in a diligent and timely manner in order to protect the
rights of the
21
parties in the Patent Rights to the Collaboration Lead or Bracco Lead. In the
event such party elects to so respond or defend, the other party will cooperate
with the responding party's legal counsel, join in such suits as may be brought
by the responding party to enforce its Patent Rights in the Collaboration Lead
or Bracco Lead, and be available at the responding party's reasonable request to
be an expert witness or otherwise to assist in such proceedings. If a party does
not exercise its right to respond to or defend against challenges or
infringements of its Patent Rights pertaining to any Collaboration Lead or
Bracco Lead as herein provided within thirty (30) days of becoming aware of or
being notified of such challenges or infringements, then the other party shall
have the option to do so at its sole cost; PROVIDED that in such case all
amounts so recovered from such third party shall be retained by the party
undertaking such response or defense and the party so responding shall have no
further obligations to the other party with respect to the response or defense
thereof.
ARTICLE 9. CONFIDENTIALITY AND PUBLICITY
9.1. Confidentiality Obligations. During the term of this Agreement and
for a period of ***** following the expiration or earlier termination hereof,
each party shall maintain in confidence the Confidential Information of the
other party, and shall not disclose, use or grant the use of the Confidential
Information of the other party, except on a need-to-know basis to such party's
directors, officers and employees, and such party's consultants and
collaborators, to the extent such disclosure is reasonably necessary in
connection with such party's activities as expressly authorized by this
Agreement. To the extent that disclosure to any person is authorized by this
Agreement, prior to disclosure, a party shall obtain written agreement of such
person to hold in confidence and not disclose, use or grant the use of the
Confidential Information of the other party except as expressly permitted under
this Agreement. Each party shall notify the other party promptly upon discovery
of any unauthorized use or disclosure of the other party's Confidential
Information. Upon the expiration or earlier termination of this Agreement, each
party shall return to the other party all tangible items regarding the
Confidential Information of the other party and all copies thereof; provided,
however, that each party shall have the right to retain one (1) copy for its
legal files for the sole purpose of determining its obligations hereunder. The
confidentiality obligations under this Section 9.1 shall not apply to the extent
that a party is required to disclose information by applicable law, regulation
or order of a governmental agency or a court of competent jurisdiction;
provided, however, that to the extent practicable, such party (a) shall provide
advance written notice thereof to the other party and consult with the other
party prior to such disclosure with respect thereto, and (b) shall provide the
other party with reasonable assistance, as requested by the other party, to
object to any such disclosure or to request confidential treatment thereof, and
(c) shall take reasonable action to avoid and/or minimize the extent of such
disclosure.
9.2. Announcements. No public announcement concerning (i) the existence
or terms of this Agreement, (ii) any research and/or discoveries related to this
Agreement made by either party, (iii) any milestones achieved by Bracco with
respect to the subject matter of this Agreement, or (iv) any exercise by either
party of rights and options granted under this
- -----------------------
* Confidential Treatment has been requested for the marked portions.
22
Agreement, shall be made, either directly or indirectly, by any other party to
this Agreement without first obtaining the approval of the other party and
agreement upon the nature and text of such announcement, such approval and
agreement not to be unreasonably withheld or delayed; provided, however, that
the foregoing shall not restrict disclosure of any information necessary or
required to be disclosed in connection with a public offering of securities or
any filing with the Securities and Exchange Commission, or as may otherwise be
required for recording purposes. The party desiring to make any public
announcement not permitted by the preceding sentence shall use its best efforts
to provide the other party with a written copy of the proposed announcement or
disclosure at least five (5) business days prior to public release to allow such
other party to comment upon such announcement or disclosure. This Section 9.2
shall not apply to any information in a public announcement that is information
essentially identical to that contained in a previous public announcement agreed
to pursuant to this paragraph.
ARTICLE 10. WARRANTIES AND REPRESENTATIONS
10.1. Representations and Warranties of Dyax.
a. Corporate Power. Dyax is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware,
and has full corporate power and authority to enter into this Agreement and to
carry out the provisions hereof.
b. Due Authorization. The execution, delivery and performance
of this Agreement have been duly authorized by all necessary corporate action on
the part of Dyax, and the person executing this Agreement on behalf of Dyax has
been duly authorized to do so by all requisite corporate action.
c. Binding Agreement; No Conflict. This Agreement is and shall
be a legal and valid obligation binding upon Dyax, enforceable in accordance
with its terms. The execution, delivery and performance of this Agreement by
Dyax, and the granting of the licenses to Bracco hereunder, do not conflict with
any agreement, instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor violate any material law or regulation of
any court, governmental body or administrative or other agency having
jurisdiction over it.
d. Grant of Rights. Dyax possesses the exclusive right, title
and interest to the Dyax Technology for the purposes of granting the licenses to
Bracco hereunder and other than with respect to an Existing Agreement, Dyax has
not, and will not while this Agreement is in effect, grant any right to any
third party that would conflict with the rights granted to Bracco hereunder.
e. No Misappropriation. None of the Dyax Technology has been
acquired without permission or has been misappropriated and its use will not
constitute a misappropriation of any invention, trade secret or proprietary
information of any third party.
f. Claims. Except for George Pieczenik and I.C. Technologies
America, Inc., no person has asserted or made any claim that any part of Dyax
Technology infringes any
23
intellectual property or other proprietary rights of a third party, and Dyax is
not aware of any other existing or threatened claim.
10.2. Representations and Warranties of Bracco.
a. Corporate Power. Bracco is a corporation duly organized,
validly existing and in good standing under the laws of the Netherlands, and has
full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof.
b. Due Authorization. The execution, delivery and performance
of this Agreement have been duly authorized by all necessary corporate action on
the part of Bracco, and the person executing this Agreement on behalf of Bracco
has been duly authorized to do so by all requisite corporate action.
c. Binding Agreement. This Agreement is and shall be a legal
and valid obligation binding upon Bracco, enforceable in accordance with its
terms. The execution, delivery and performance of this Agreement by Bracco does
not conflict with any agreement or instrument to which it is a party or by which
it may be bound, nor violate any material law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over it.
10.3. Disclaimer of Warranties by Dyax. Nothing in this Agreement shall
be construed as a warranty or representation by Dyax that the use of the Dyax
Technology or the inventions contained therein will result in any Collaboration
Leads or Bracco Leads, that any of the Dyax Leads, Collaboration Leads or the
Bracco Leads will result in any Licensed Products, that the exploitation of the
Dyax Technology, the Dyax Leads, the Collaboration Leads, the Bracco Leads or
the Collaboration Results will be free from infringement of patents of third
parties. DYAX DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND WITH REGARD TO THE
DYAX TECHNOLOGY, THE DYAX LEADS, THE COLLABORATION LEADS AND THE COLLABORATION
RESULTS, 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.
10.4. Disclaimer of Warranties by Bracco. Nothing in this Agreement
shall be construed as a warranty or representation by Bracco that the use of any
Bracco Imaging Chelates or of any of the Collaboration Leads or Bracco Leads by
Dyax will result in any products or as a warranty or representation by Bracco
that the exploitation of any Bracco Imaging Chelates, Collaboration Leads,
Bracco Leads or Collaboration Results by Dyax will be free from infringement of
patents of third parties. BRACCO DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND
WITH REGARD TO BRACCO IMAGING CHELATES AND ANY COLLABORATION LEADS, BRACCO LEADS
OR COLLABORATION RESULTS, 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.
24
10.5. Limitation of Liability. Neither party shall be liable to the
other for consequential, incidental, indirect or punitive damages arising from
the performance of nonperformance of such party under this Agreement.
ARTICLE 11. INDEMNIFICATION
11.1. Indemnification of Dyax by Bracco. Bracco shall defend, indemnify
and hold harmless Dyax and its directors, officers, shareholders, agents and
employees, from and against any and all liability, loss, damages and expenses
(including reasonable attorneys' fees) as the result of claims, demands, actions
or proceedings by any third party which are made or instituted against them
arising out of the use or the Dyax Technology by Bracco or the development,
manufacture, possession, distribution, use, testing, sale or other disposition
of any Dyax Lead, Collaboration Lead, Bracco Lead or Licensed Product by or
through Bracco, its distributors, licensees or sublicensees. Bracco's obligation
to defend, indemnify and hold harmless shall include claims, demands, actions or
proceedings, whether for money damages or equitable relief by reason of alleged
personal injury (including death) to any person or alleged property damage,
provided, however, the indemnity shall not extend to any claims against an
indemnified party which result from the gross negligence or willful misconduct
of an indemnified party. Bracco shall have the exclusive right to control the
defense of any action which is to be indemnified in whole by Bracco hereunder,
including the right to select counsel reasonably acceptable to Dyax to defend
the indemnified parties hereunder, and to settle any claim, demand, action or
proceeding, provided that, without the prior written consent of Dyax (which
shall not be unreasonably withheld or delayed), Bracco shall not agree to settle
any claim, demand, action or proceeding, to the extent such settlement would
have a material adverse effect on Dyax. The provisions of this paragraph shall
survive and remain in full force and effect after any termination, expiration or
cancellation of this Agreement.
11.2. Indemnification of Bracco by Dyax. Dyax shall defend, indemnify
and hold harmless Bracco and its directors, officers, shareholders, agents and
employees, from and against any and all liability, loss, damages and expenses
(including reasonable attorneys' fees) as the result of claims, demands, actions
or proceedings by any third party which are made or instituted against any of
them arising out of the development, manufacture, possession, distribution, use,
testing, sale or other disposition of any Dyax Chelated Product or any
Collaboration Lead or Bracco Lead by or through Dyax. Dyax's obligation to
defend, indemnify and hold harmless shall include claims, demands, actions or
proceedings, whether for money damages or equitable relief by reason of alleged
personal injury (including death) to any person or alleged property damage,
provided, however, the indemnity shall not extend to any claims against an
indemnified party which result from the gross negligence or willful misconduct
of an indemnified party. Dyax shall have the exclusive right to control the
defense of any action which is to be indemnified in whole by Dyax hereunder,
including the right to select counsel reasonably acceptable to Bracco to defend
the indemnified parties hereunder, and to settle any claim, demand, action or
proceeding, provided that, without the prior written consent of Bracco (which
shall not be unreasonably withheld or delayed), Dyax shall not agree to settle
any claim, demand, action or proceeding, to the extent such settlement would
have a material adverse effect on
25
Bracco. The provisions of this paragraph shall survive and remain in full force
and effect after any termination, expiration or cancellation of this Agreement.
11.3. Indemnification Procedure. A person or entity that intends to
claim Indemnification under this Article 11 (the "Indemnitee") shall promptly
notify the other party (the "Indemnitor") of any claim, demand, action or
proceeding for which the Indemnitee intends to claim such indemnification, and
the Indemnitor, after it determines that indemnification is required of it,
shall assume the defense thereof with counsel selected by the Indemnitor and
reasonably acceptable to the other party; provided, however, that an Indemnitee
shall have the right to retain its own counsel, with the fees and expenses to be
paid by the Indemnitor if the Indemnitor does not assume the defense or if
representation of such Indemnitee by the counsel retained by the Indemnitor
would be inappropriate due to actual or potential conflicts of interest between
such Indemnitee and any other party represented by such counsel in such
proceedings. The indemnity agreement in this Article 11 shall not apply to
amounts paid in settlement of any claim, demand, action or proceeding if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld or delayed. The failure to deliver notice to
the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve such
Indemnitor of any liability to the Indemnitee under this Article 11 but failure
to deliver notice to the Indemnitor will not relieve it of any liability that it
may have to any Indemnitee otherwise than under this Article 11. The Indemnitee
under this Article 11, its employees and agents, shall reasonably cooperate with
the Indemnitor and its legal representatives in the investigations of any claim,
demand, action or proceeding covered by this indemnification. In the event that
each party claims indemnity from the other and one party is finally held liable
to indemnify the other, the Indemnitor shall additionally be liable to pay the
reasonable legal costs and attorneys' fees incurred by the Indemnitee in
establishing its claim for indemnity.
ARTICLE 12. TERM AND TERMINATION.
12.1. Term. This Agreement shall come into effect as of the Effective
Date, and unless earlier terminated as provided in this Article 12, shall remain
in full force and effect until the last to expire of the parties' respective
royalty obligations under this Agreement. The Research Term shall commence on
the Effective Date and shall remain in effect for a period of three years;
provided however the Research Term shall automatically renew for one successive
three year term provided that the parties have achieved the two Collaboration
Goals set forth in Section 3.1. The parties may thereafter agree to extend the
Research Term on mutually agreeable terms.
12.2. Termination by Bracco. Bracco may terminate this Agreement at any
time after the expiration of the Research Term, by giving 6 months prior written
notice to Dyax.
12.3. Termination by Dyax. Dyax may terminate the exclusive license to
the Dyax Technology if the Research Term is not automatically renewed for one
successive three year term as provided in Section 12.1.
26
12.4. Termination for Default. A party shall have the right to
terminate this Agreement (a) upon the breach by the other party of the other
party's obligations to pay any amounts owing hereunder, if such breach is not
cured within thirty (30) days after receipt of written notice from such party
thereof, or (b) upon the material breach by the other party of the other party's
obligations, if such breach is not cured within sixty (60) days after receipt of
written notice from such party thereof.
12.5. Effect of Termination. Upon the expiration or termination of this
Agreement, Bracco's rights under the licenses and options granted pursuant to
Article 4 shall terminate. Notwithstanding the foregoing, and subject to the
payment provisions of Sections 6.4, 6.5, 6.6 and 6.7, Bracco may continue to
develop, make, sell, import and distribute any Licensed Product in existence at
the time of termination and to the extent any rights granted hereunder to the
Dyax Leads, Collaboration Leads, Bracco Leads and Collaboration Results
pertaining to such leads are required to develop, make, sell import and
distribute such Licensed Products such rights shall survive only for such
purposes. Should Bracco's license to the Dyax Technology terminate, Bracco shall
retain the exclusive rights to the Collaboration Leads, Bracco Leads and the
Collaboration Results pertaining to such leads to research, develop, make, sell,
import and distribute Licensed Products in the Collaboration Field as herein
provided subject to the provisions of Sections 5.3 and 5.4 (if applicable) and
the obligations of Bracco to make payments to Dyax pursuant Sections 6.4, 6.5,
6.6 and 6.7. Subject to the continuation of any payment obligations of Dyax
pursuant to Section 6.8, Dyax may continue to develop, make, sell and distribute
any Dyax Chelated Products and to the extent any rights granted hereunder to the
Bracco Chelates are required to develop, make, sell, import and distribute Dyax
Chelated Products such rights shall survive only for such purposes. Upon the
expiration or termination of this Agreement, either party may continue to use
the Collaboration Results that are generally useful but not specific to any
Collaboration Lead and each party may continue to use the Joint Inventions in
its core areas of technology and expertise. The following provisions shall
survive the expiration or termination of this Agreement: Articles 1, 7, 8, 9 11
and Sections 4.7, 5.3, 5.4 and 5.5 to the extent it pertains to a Collaboration
Lead that Dyax has obtained the rights to pursuant to Section 5.3, as well as
any provision not specified in this Section 12.4 which is expressly stated to
survive termination of this Agreement.
ARTICLE 13. DISPUTE RESOLUTION
13.1. Arbitration.
a. If a dispute arises concerning or related to this
Agreement, the parties hereto commit to enter into good faith efforts for a
period of 30 days to resolve the dispute in a meeting or meetings in which a
senior official or officials with decision-making power shall participate.
b. Upon the expiration of the 30 day period, either party may
proceed with arbitration before the American Arbitration Association to resolve
the subject dispute. The dispute referred to hereof shall be finally decided by
a panel of three arbitrators, one appointed by each of the parties and a third,
who shall act as president, to be appointed, either by agreement
27
between the two arbitrators or, in the absence of an agreement (within 10 days
after the appointment of the two arbitrators), by the Chairman of the American
Arbitration Association (the three arbitrators collectively referred to as the
"Arbitration Panel"). The party requesting arbitration shall notify the other
party in writing of its intention to arbitrate and shall at the same time
indicate its own appointed arbitrator. The party receiving such notice shall
within 30 days of receipt of such notice appoint its own arbitrator and notify
the other party in writing of such appointment. The Chairman of the American
Arbitration Association shall proceed with the appointment of an arbitrator if
either (i) any party required to proceed with such an appointment shall not have
done so within such 30-day period or (ii) the parties do not agree on the
appointment of the third arbitrator as set forth above.
c. The arbitration shall be conducted in accordance with the
Rules of the American Arbitration Association then in effect. The parties
expressly agree to waive all rights of appeals relating to the award of the
Arbitration Panel. The Arbitration Panel shall be in New York City, the
proceedings shall be in the English language and the substantive laws of the
State of New York shall exclusively apply (without regard to any New York choice
of law rules).
d. The parties shall be entitled to discover all documents and
other information reasonably necessary for a full understanding of any
legitimate issue raised in an arbitration proceeding provided that the foregoing
shall be subject to the attorney-client, work product and other applicable
privileges. The parties may use all methods of discovery customary under the
Rules of the Arbitration Association then in effect. The time periods for
compliance shall be determined by the rules of the American Arbitration
Association. The Arbitration Panel shall make such orders as may be necessary
for the Arbitration Panel to obtain appropriate or necessary evidence.
e. The Arbitration Panel shall issue a written explanation in
English of the reason for any arbitration award and a full statement of the
facts as found and the rules of law applied in reaching its decision.
f. An award rendered in connection with an arbitration
proceeding pursuant to this Section 13 shall be final and binding upon the
parties, and any judgment upon such award may be entered and enforced in any
court of competent jurisdiction.
g. The parties hereto agree that an award of the Arbitration
Panel shall be the sole and exclusive remedy regarding any and all claims and
counterclaims with respect to the subject matter of the arbitrated dispute. The
parties waive all jurisdictional and venue defenses in connection with any
arbitration hereunder or the enforcement of an order or award rendered pursuant
thereto (assuming that the terms and conditions of this Article 13 have been
complied with).
h. This Article 13 shall not apply to any claims for
injunctive or other equitable relief, any of which may be brought by either
party against the other in a court of competent jurisdiction.
28
i. With respect to any order issued by the Arbitration Panel
pursuant to this Agreement, the parties expressly agree and consent (i) to the
bringing of an action by one party against another party in the courts of either
the Netherlands or the federal courts of the United States (provided that if the
federal courts of the United States decline jurisdiction the action may be
brought in the courts of the State of New York) to enforce and confirm such
order; (ii) that such order shall be conclusive proof of the validity of the
determination of the Arbitration Panel underlying such order and that either the
Netherlands or the United States court may enter judgment upon and enforce such
order, whether pursuant to the Convention or Recognition and Enforcement of
Foreign Arbitral Awards or otherwise.
j. Either party that desires to make a stenographic record of
any arbitration proceedings may do so at its own expense.
ARTICLE 14. MISCELLANEOUS
14.1. Notices. All notices required 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, 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 Bracco:
Dyax Corp. Bracco Holding, B. V.
One Kendall Square, Bldg. 600
Cambridge, MA 02139
Attention: Chief Executive Officer Attention: Mr. T. Herbschleb
Facsimile: (617) 225-2501 Facsimile: 0031 20 3012160
With a copy to:
BraccoInternational, B.V.
Swiss Branch Office
Attention: Prof. E. Felder
Facsimile: 0041 91 9853020
And
Bracco Research USA, Inc.
Attention: Michael Tweedle
Facsimile: 609-514-2446
Either party may change its designated address and facsimile number by notice to
the other party in the manner provided in this Section.
29
14.2. Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party, except that either party
may assign this Agreement to any of its Affiliates or to a successor in
connection with the merger, consolidation, or sale of all or substantially all
of its assets or that portion of its business pertaining to the subject matter
of this Agreement, with prompt written notice to the other party of any such
assignment. This Agreement shall inure to the benefit of and be binding upon the
parties and their respective lawful successors and assigns.
14.3. Force Majeure. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected party, including but not limited to fire, floods,
embargoes, war, acts of war (whether war is declared or not), riots, strikes,
lockouts or other labor disturbances, lawsuits, acts of God, or acts, omissions
or delays in acting by any court, governmental authority or the other party.
14.4. Choice of Law. This Agreement shall be governed by, construed and
enforced under the laws of the State of New York (without reference to the
conflicts of law principles thereof).
14.5. 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.
14.6. 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 their original intent.
14.7. Entire Agreement. This Agreement 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.
30
IN WITNESS WHEREOF, the undersigned have duly executed and
delivered this Agreement as of the date first above written.
DYAX CORP. BRACCO HOLDING, B.V.
By: /s/ Henry E. Blair By: /s/ Diana Bracco
--------------------------------- -------------------------------
Name: Henry E. Blair Name: Diana Bracco
Title: Chairman & CEO Title: Chairman
BRACCOINTERNATIONAL, B.V.
By: /s/
-------------------------------
31
Attachment A
Representative Examples of Bracco Patent Rights
U.S. Patent No. 5,808,091 Rhenium and Technetium Complexes Containing a Hypoxia
Localizing Moiety
U.S. Patent No. 5,665,329 Heteroatom-Bearing Ligands and Metal Complexes Thereof
U.S. Patent No. 5,387,409 Boronic Acid Adducts of Rhenium Dioxime and
Technetium-99m Dioxime Complexes Containing a Biochemically Active Group
U.S. Patent No. 5,183,653 Boronic Acid Adducts of Metal Dioxime Complexes Useful
in Labeling Proteins and Other Amine-Containing Compounds
U.S. Patent No. 4,885,363 1-Substituted-1,4,7-Triscarboxymethyl-1,4,7,
10-Tetraazacyclododecane and Analogs
U.S. Serial No. 08/469,544 Method for Imaging and Radiopharmaceutical Therapy
Using 1-Substituted-4,7,10-Tricarboxymethyl-1,4,7,10-Tetraazacyclododecane and
Analogs
U.S. Patent No. 5,271,928 Stable Microbubble Suspensions Injectable Into Living
Organisms
U.S. Patent No. 5,578,292 Long Lasting Aqueous Dispersions or Suspensions of
Pressure-Resistant Gas-Filled Microvesicles and Methods for the Preparation
Thereof
U.S. Patent No. 5,556,610 Gas Mixtures Useful as Ultrasound Contrast Media,
Contrast Agents Containing the Media and Method
U.S. Patent No. 5,711,933 Method of Making Polymeric Gas or Air Filled
Microballoons for Ultrasonic Echography
Int'l Publication No. WO 99/39738 Targeted Delivery of Biologically Active Media
U.S. Patent No. 5,910,300 Amphiphilic Linkers for Coupling Administrable
Diagnostically or Physiologically Active Agents and Bioselective Targeting
Compounds
U.S. Patent No. 5,833,948 Blood-Pool Imaging Composition Comprising Micelles
Containing a Lipophilic Chelating Agent and a Non-Ionic Surfactant
U.S. Patent No. 5,571,940 Method for Making Conjugate Moieties Capable of
Chelating Paramagnetic Metals and Designed for Coupling With a Factor Responsive
to Specific Cellular Marker Sites
32
U.S. Patent No. 5,464,696 Particles for NMR Imaging
Int'l Publication No. WO 96/25955 Liposome Suspensions as Blood Pool Imaging
Contrast Agents
U.S. Patent No. 6,099,824 Benzyloxy Derivatives of DTPA for MRI
U.S. Patent No. 5,807,971 Selectively Functionalizable Desdendrimers
U.S. Patent No. 5,622,688 Macrocyclic Chelants, Their Chelates and Uses Thereof
in the Diagnostic Field
U.S. Patent No. 5,780,644 Branched Polyoxaalkyl Macromolecules
U.S. Patent No. 5,733,528 Paramagnetic Chelates for Nuclear Magnetic Resonance
Diagnosis
U.S. Patent No. 5,660,814 Iodinated Paramagnetic Chelates, and Their Use as
Contrast Agents
U.S. Patent No. 5,182,370 Paramagnetic Chelates
U.S. Patent No. 5,132,409 Macrocyclic Chelating Agents and Chelates Thereof
Int'l Publication No. WO 99/35134 1,4,7,10-Tetraazacyclododecane-1,4-Diacetic
Acid
Representative Patents and Applications Owned By Resolution Pharmaceuticals Inc.
A list of representative patents and applications currently owned by
Resolution Pharmaceuticals Inc. is set forth below. Bracco and Resolution
Pharmaceuticals Inc. have signed a term sheet for a transaction in which these
patents and applications would be assigned to Bracco. If a contract between
Bracco and Resolution Pharmaceuticals Inc. is agreed upon and executed, these
patents and applications will be assigned to Bracco and become part of the
Bracco chelate patent portfolio.
U.S. Patent No. 5,789,555 Immobilized Labeling Method
U.S. Patent No. 5,976,495 Peptide Derived Radionuclide Chelators
U.S. Patent No. 5,866,544 Peptide-Chelator Conjugates
U.S. Patent No. 5,659,041 Hydrazino-Type Radionuclide Chelators Having anN2S
Configuration
33
Attachment B
*****
- ----------------------
* Confidential Treatment has been requested for the marked portions.
34
Attachment C
*****
- ----------------------
* Confidential Treatment has been requested for the marked portions.
35