Document:

Exhibit 10.2

 

DYAX CORP.

 

1998 Employee Stock Purchase Plan

 

1.             Purpose.

 

The purpose of this 1998
Employee Stock Purchase Plan (the “Plan”) is to provide employees of Dyax Corp.
(the “Company”), and its subsidiaries incorporated under the laws of a jurisdiction
within the United States of America (“US Subsidiaries”), who wish to become
shareholders of the Company, an opportunity to purchase Common Stock, $0.01 par
value, of the Company (the “Common Stock”) directly from the Company.  The Plan is intended to qualify as an “employee
stock purchase plan” within the meaning of Section 423 of the Internal
Revenue Code of 1986, as amended (the “Code”).

 

2.             Eligible
Employees.

 

Subject to the provisions of
Sections 7, 8, 9 and 10 below, any individual who is a full-time employee (as
defined below) of the Company or of any of its subsidiaries (as defined in Section 424(f) of
the Code) designated for eligibility to participate in the Plan by the Board of
Directors is eligible to participate in any Offering of Shares (as defined in Section 3
below) made by the Company hereunder.  “Board
of Directors” means the Company’s Board of Directors or any committee to
whom it delegates its authority hereunder, and “full-time employee”
shall mean any employee whose customary employment is:

 

(a)           20 hours or more per week
and

 

(b)           more than five months in the
calendar year during which the Offering Date (as defined in Section 3
below) occurs (or in the calendar year immediately preceding such calendar year
if there has been no change in the terms of employment that would make the
employee ineligible to participate in the current calendar year).

 

3.             Offering Dates.

 

From time to time, the
Company, by action of the Board of Directors, will grant rights to purchase
Shares to employees eligible to participate in the Plan pursuant to one or more
offerings (each of which is an “Offering” on a date or series of dates (each of
which is an “Offering Date”) designated for this purpose by the Board of
Directors.

 

4.             Prices.

 

The price per share for each
grant of rights hereunder shall be the lesser of:

 

(a)           eighty-five percent (85%) of
the fair market value of a Share on the Offering Date on which such right was
granted; or

 

(b)           eighty-five percent (85%) of
the fair market value of a Share on the date such right is exercised.

 

 

At its discretion, the Board
of Directors may determine a higher price for a grant of rights.

 

5.             Exercise of
Rights and Method of Payment.

 

(a)           Rights granted under the
Plan will be exercisable periodically on specified dates as determined by the
Board of Directors. Unless a participating employee withdraws from the Plan as
provided in Section 11, and subject to the other terms of the Plan, the
employee’s option for the purchase of Shares will be exercised automatically on
each Purchase Date of an Offering Period, and the maximum number of shares
subject to the option will be purchased at the applicable purchase price with
the accumulated contributions in the employee’s account.

 

(b)           The method of payment for
Shares purchased upon exercise of rights granted hereunder shall be through
regular payroll deductions or by lump sum cash payment, by delivery of shares
of Common Stock valued at fair market value (as determined by the Board of
Directors) on the date of delivery, or by some combination thereof, as
determined by the Board of Directors.  No
interest shall be paid upon payroll deductions unless specifically provided for
by the Board of Directors.

 

(c)           Any payments received by the
Company from a participating employee and not utilized for the purchase of
Shares upon exercise of a right granted hereunder shall be promptly returned to
such employee by the Company after termination of the right to which the
payment relates.

 

6.             Term of Rights.

 

The total period from an
Offering Date to the last date on which rights granted on that Offering Date
are exercisable (the “Offering Period”) shall in no event be longer than twenty-seven
(27) months or such longer period as may then be consistent with Section 423
of the Code.  The Board of Directors when
it authorizes an Offering may designate one or more exercise periods during the
Offering Period when shares will be purchased upon exercise of employees’
options (each, an “Exercise Period”). 
Rights granted on an Offering Date shall be exercisable in full on the
Offering Date or in such proportion on the last day of each exercise period as
the Board of Directors determines.

 

7.             Shares Subject
to the Plan.

 

(a)           The number of shares of
Common Stock that may be sold pursuant to rights granted under the Plan may not
exceed 1,330,000 shares (the “Shares”); provided, however, that the maximum
number of Shares which shall be available for sale under the Plan during any
Exercise Period shall not exceed the number of Shares equal to 25,000 Shares multiplied
by the number of calendar quarters included in such Exercise Period and, if
necessary, the number of Shares sold during an Exercise Period shall be cut
back in accordance with Section 7(b). 
Appropriate adjustments in the above figures, in the number of Shares
covered by outstanding rights granted hereunder, in the exercise price of the
rights and in the maximum number of Shares which an employee may purchase
(pursuant to this Section 7(a), and Sections 9 and 10 below) shall be made
to give effect to any mergers, consolidations, reorganizations,
recapitalizations, stock splits, stock dividends or other relevant changes in
the capitalization of 

 

 

the Company occurring after
the effective date of the Plan, provided that no fractional Shares shall be
subject to a right and each right shall be adjusted downward to the nearest
full Share.  In the event of a proposed
dissolution or liquidation of the Company, any Exercise Period and Offering
Period then in progress will terminate immediately prior to the consummation of
such action, unless otherwise provided by the Board.  In the event of a Corporate Transaction (as
defined below), each option outstanding under the Plan shall be assumed or an
equivalent option shall be substituted by the successor corporation or a parent
or subsidiary of such successor corporation. 
In the event that the successor corporation refuses to assume or
substitute for outstanding options, each Exercise Period and Offering Period
then in progress shall be shortened and a new Purchase Date shall be set (the “New
Purchase Date”), as of which date any Exercise Period and Offering Period then
in progress will terminate.  The New
Purchase Date shall be on or before the date of consummation of the transaction
and the Board shall notify each participating employee in writing, prior to the
New Purchase Date, that the Purchase Date for his or her option has been
changed to the New Purchase Date and that his or her option will be exercised
automatically on the New Purchase Date, unless prior to such date he or she has
withdrawn from the Offering Period as provided in Section 11.  For purposes of this Section 7, “Corporate
Transaction” means a sale of all or substantially all of the Company’s assets,
or a merger, consolidation, or other capital reorganization of the Company with
or into another corporation, or any other transaction or series of related
transactions in which the Company’s stockholders immediately prior thereto own
less than 50% of the voting stock of the Company (or its successor or parent)
immediately thereafter.  Either
authorized and unissued Shares or issued Shares heretofore or hereafter
reacquired by the Company may be made subject to rights under the Plan.  If for any reason any right under the Plan
terminates in whole or in part, Shares subject to such terminated right may
again be subjected to a right under the Plan.

 

(b)           Subject to the foregoing, if
the Board of Directors determines that, on a given purchase date for an
Offering (a “Purchase Date”), the number of Shares with respect to which rights
are to be exercised may exceed (i) the number of Shares of Common Stock
that were available for sale under the Plan on the Offering Date of the
applicable Offering, or (ii) the number of Shares available for sale under
the Plan on such Purchase Date, the Board of Directors may in its sole
discretion provide that the Company shall make a pro rata allocation of the
Shares of Common Stock available for purchase on such Offering Date or Purchase
Date, as applicable, in as uniform a manner as shall be practicable and as it
shall determine in its sole discretion to be equitable among all participant
employees exercising rights to purchase Common Stock on such Purchase Date, and
(x) continue all Offerings then in effect or (y) terminate any or all
Offerings then in effect.  The Company
may make pro rata allocation of the Shares available on the Purchase Date of
any applicable Offering, notwithstanding any authorization of additional Shares
for issuance under the Plan by the Company’s stockholders subsequent to the
Offering Date for such Offering.  In the
event of a pro-rata allocation, each participating employee’s right to purchase
Shares shall be limited to such pro-rata amount of Shares and the remaining
cash balance of the contributions shall be credited to his or her account, and
the participating employees shall not have further rights against the Company
or the Board of Directors.

 

 

8.             Limitations on
Grants.

 

(a)           No employee shall be granted
a right hereunder if such employee, immediately after the right is granted,
would own stock or rights to purchase stock possessing five percent (5%) or
more of the total combined voting power or value of all classes of stock of the
Company, or of any subsidiary, computed in accordance with Section 423(b)(3) of
the Code.

 

(b)           No employee shall be granted
a right which permits the employee’s right to purchase shares under all
employee stock purchase plans of the Company and its subsidiaries to accrue at
a rate which exceeds twenty-five thousand dollars ($25,000) (or such other
maximum as may be prescribed from time to time by the Code) of the fair market
value of such Shares (determined at the time such right is granted) for each
calendar year in which such right is outstanding at any time in accordance with
the provisions of Section 423(b)(8) of the Code.

 

(c)           No right granted to any
participating employee under an Offering, when aggregated with rights granted
under any other Offering still exercisable by the participating employee, shall
cover more shares than may be purchased at an exercise price not to exceed
fifteen percent (15%) of the employee’s annual rate of compensation on the date
the employee elects to participate in the Offering or such lesser percentage as
the Board of Directors may determine.

 

9.             Limitation on
Number of Shares Purchased.

 

The maximum number of Shares
that an eligible participating employee may purchase during any Exercise Period
shall not exceed the number of Shares that is equal to 875 Shares multiplied by
the number of calendar quarters included in such Exercise Period, provided that
such purchase shall be further subject to the limitations set forth in Sections
2, 7, and 8.

 

10.          Limit on
Participation.

 

Participation in an Offering
shall be limited to eligible employees who elect to participate in such
Offering in the manner, and within the time limitations, established by the
Board of Directors when it authorizes the Offering.

 

11.          Withdrawal.

 

(a)           An employee who has elected
to participate in an Offering may cancel such election as to all (but not part)
of the unexercised rights granted under such Offering by giving written notice
of such cancellation to the Company before the date established by the Company
for such purpose.  Upon such withdrawal,
any amounts paid by the employee or withheld from the employee’s compensation
through payroll deductions for the purpose of purchasing Shares shall be paid
to the employee, without interest, unless otherwise determined by the Board of
Directors.

 

(b)           A participating employee’s
withdrawal from an Offering will not have any effect upon his or her
eligibility to participate in a succeeding Offering which commences after the
withdrawal or in any similar plan that may hereafter be adopted by the Company.  If a participating employee withdraws from an
Offering, however, payroll deductions shall not 

 

 

resume at the beginning of
any succeeding Offering unless the employee makes a new election to participate
in the Plan.

 

12.          Tax Withholding.

 

Each participating employee
shall pay to the Company or the applicable subsidiary, or make provision
satisfactory to the Administrator for payment of, any taxes required by law to
be withheld in respect of the purchase or disposition of Shares no later than
the date of the event creating the tax liability.  In the discretion of the Board of Directors
and subject to applicable law, such tax obligations may be paid in whole or in
part by delivery of Shares to the Company, including Shares purchased under the
Plan, valued at fair market value (as determined by the Board of Directors) on
the date of delivery.  The Company or the
applicable subsidiary may, to the extent permitted by law, deduct any such tax
obligations from any payment of any kind otherwise due to the employee or
withhold Shares purchased hereunder, which shall be valued at fair market value
(as determined by the Board of Directors) on the date of withholding.

 

13.          Termination of
Employment.

 

Upon the termination of
employment for any reason, including the death of the employee, before the date
on which any rights granted under the Plan are exercisable, all such rights
shall immediately terminate and amounts paid by the employee or withheld from
the employee’s compensation through payroll deductions for the purpose of
purchasing the Shares shall be paid to the employee or to the employee’s
estate, without interest unless otherwise determined by the Board of Directors.

 

14.          Participants’
Rights as Shareholders and Employees.

 

(a)           No participating employee
shall have any rights as a shareholder in the Shares covered by a right granted
hereunder until such right has been exercised, full payment has been made for
the corresponding Shares and the Share certificate is actually issued.

 

(b)           Each participating employee
is an employee-at-will (that is to say that either the employee or the Company
or any subsidiary may terminate the employment relationship at any time for any
reason or no reason at all) unless and only to the extent provided in a written
employment agreement for a specified term executed by the chief executive
officer of the Company or his duly authorized designee or the authorized
signatory of any subsidiary.  Neither the
adoption, maintenance, nor operation of the Plan nor any grant of rights
hereunder shall confer upon any employee any right with respect to the
continuance of his/her employment with the Company or any subsidiary nor shall
they interfere with the rights of the Company or subsidiary to terminate any
employee at any time or otherwise change the terms of employment, including,
without limitation, the right to promote, demote or otherwise re-assign any
employee from one position to another within the Company or any subsidiary.

 

15.          Rights Not
Transferable.

 

Rights under the Plan are
not assignable or transferable by a participating employee and are exercisable
only by the employee.

 

 

16.          Amendments to
or Discontinuation of the Plan.

 

The Board of Directors of
the Company shall have the right to amend, modify or terminate the Plan at any
time without notice; provided, however, that the then existing rights of all
participating employees shall not be adversely affected thereby, and provided
further that, subject to the provisions of Section 7 above, no such
amendment to the Plan shall, without the approval of the shareholders of the
Company, increase the total number of Shares which may be offered under the
Plan.

 

17.          Effective Date
and Approvals.

 

(a)                           This Plan
became effective on January 31, 1998, the date it was adopted by the Board
of Directors, and it was approved by the shareholders of the Company within
twelve (12) months before or after the date of adoption.

 

(b)                           The Company’s
obligation to offer, sell and deliver the Shares under the Plan is subject to (i) the
approval of any governmental authority required in connection with the
authorization,  issuance or sale of such
Shares, (ii) satisfaction of the listing requirements of any national
securities exchange on which the Shares are then listed and (iii) compliance,
in the opinion of the Company’s counsel with, all applicable federal and state
securities and other laws.

 

18.          Term of Plan.

 

No rights shall be granted
under the Plan after January 30, 2017.

 

19.          Administration
of the Plan.

 

The Board of Directors or
any committee or person(s) to whom it delegates its authority (the “Administrator”)
shall administer, interpret and apply all provisions of the Plan as it deems
necessary to meet special circumstances not anticipated or covered expressly by
the Plan.  Nothing contained in this Section shall
be deemed to authorize the Administrator to alter or administer the provisions
of the Plan in a manner inconsistent with the provisions of Section 423 of
the Code.  Determinations made by the
Board of Directors with respect to any provision of the Plan or matter arising in
connection therewith shall be final, conclusive and binding upon the Company
and upon all participants, their heirs or legal representatives.

 

20.          Governing Law.

 

Subject to overriding
federal law, the Plan shall be governed by and interpreted consistently with
the laws of the State of Delaware.Exhibit
10.19

 

LICENSE
AGREEMENT

 

BY AND BETWEEN

 

DYAX CORP.

 

AND

 

FOVEA PHARMACEUTICALS SA

 

 

LICENSE AGREEMENT

 

This License Agreement (this “Agreement”) is
made and effective as of August 21, 2008 (the “Effective Date”) by and
between Dyax Corp., a Delaware corporation, with offices at 300 Technology
Square, Cambridge, Massachusetts 02139, U.S.A. (“Dyax”) and Fovea
Pharmaceuticals SA, a French corporation, with offices at 12 rue Jean-Antoine
de Baif, 75013 Paris, France (“Fovea”).

 

INTRODUCTION

 

1.             Dyax
owns or controls certain patents, know-how and other rights related to its
proprietary novel kallikrein inhibitor known as DX-88 (ecallantide);

 

2.             Fovea
has considerable knowledge and experience in developing and commercializing
ophthalmic pharmaceutical products in the countries of the European Union;

 

3.             Dyax
(as successor in interest to Dyax-Genzyme LLC) and Fovea entered into a
Research and Option Agreement effective May 26, 2006 (the “Research and
Option Agreement”), pursuant to which (a) Fovea conducted a non-clinical
study of DX-88 for the treatment of macular edema associated with retinal vein
occlusion and (b) Dyax granted Fovea an option to obtain a license to develop
and commercialize DX-88 in ophthalmic indications in the European Union, which option
was exercised by Fovea on April 2, 2007;

 

4.             Dyax
believes that a license and collaboration arrangement with Fovea regarding the
DX-88 in the ophthalmic field on the terms of this Agreement would be
desirable;

 

5.             Fovea
believes that Fovea’s participation in this arrangement with Dyax would be of
economic benefit to Dyax and Fovea; and

 

6.             On
and subject to the terms and conditions set forth herein, Dyax and Fovea
therefore desire to provide for the development, manufacture and
commercialization of DX-88 formulated for use in the ophthalmic field as
described herein.

 

NOW, THEREFORE, for and in consideration of the
mutual covenants contained herein, Dyax and Fovea hereby agree as follows:

 

ARTICLE I

DEFINITIONS

 

As
used in this Agreement, the following terms shall have the meanings set forth
below:

 

Section 1.1             “Affiliate”.  Affiliate shall mean with respect to any
Party, any Person controlling, controlled by or under common control with such
Party.  For purposes of this Section 1.1,
“control” shall mean (a) in the case of a Person that is a corporate entity,
direct or indirect ownership of more than fifty percent (50%) of the stock or
shares having the right to vote for the election of directors of such Person
and (b) in the case of a Person that is an entity, but is not a corporate
entity, the possession, 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

 

directly or indirectly, of the power to
direct, or cause the direction of, the management or policies of such Person,
whether through the ownership of voting securities, by contract or otherwise.

 

Section 1.2             “API Bulk Drug Substance”.  API Bulk Drug Substance shall mean the
Compound in bulk form manufactured for use as an active pharmaceutical
ingredient in the Product; provided [*****].

 

Section 1.3             “Blocking Third Party Patent
Rights”.  Blocking Third Party Patent
Rights shall mean, with respect to any country in the Territory, on a
country-by-country basis, Patent Rights in such country owned or controlled by
a Third Party that Cover the Product; provided, however, that any
Patent Rights owned or controlled by [*****],
shall not be deemed Blocking Third Party Patent Rights.   [*****]

 

Section 1.4             “Clinical Study”.  Clinical Study shall mean a Phase I Clinical
Study, Phase II Clinical Study, Phase III Clinical Study, Post-Approval Study
or other clinical study or trial of the Product in humans, as applicable.

 

Section 1.5             “Commercialization” or “Commercialize”.  Commercialization or Commercialize shall mean
activities directed to obtaining pricing and reimbursement approvals,
marketing, promoting, distributing, importing, exporting or selling a
product.  Commercialization shall not
include any activities related to Manufacturing.

 

Section 1.6             “Competing Product”.  Competing Product shall mean any prescription
pharmaceutical product, other than the Product, that [*****].

 

Section 1.7             “Compound”.  Compound shall mean the novel kallikrein
inhibitor known as DX-88 (ecallantide), with the amino acid sequence described
in Exhibit A.

 

Section 1.8             “Control” or “Controlled”.  Control or Controlled shall mean, with
respect to any intellectual property right or other intangible property, the
possession (whether by license from a Third Party or ownership, or by control
over an Affiliate having possession by license from a Third Party or ownership)
by a Party of the ability to grant to the other Party access, ownership and/or
a license or sublicense as provided herein without violating the terms of any
agreement with any Third Party.  For
purposes of clarification, a Party shall not be deemed or treated as
Controlling or being in Control of any intellectual property right or other
intangible property that any other Person owns or Controls solely because such
other Person becomes an Affiliate of such Party at any time after the Effective
Date pursuant to a transaction in which such other Person acquires, or becomes
a controlling stockholder of, such Party.

 

Section 1.9             “Cover”, “Covering”
or “Covered”.  Cover, Covering or
Covered shall mean, with respect to the Product or with respect to technology,
that, in the absence of a license granted under a Valid Claim, the making, use,
offering for sale, sale, or importation of the Product or the practice of such
technology would infringe such Valid Claim.

 

Section 1.10           “Development” or “Develop”.  Development or Develop shall mean
non-clinical and clinical research and drug development activities, including
without limitation toxicology, test 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

2

 

method development and stability testing,
process development, formulation development, delivery system development,
quality assurance and quality control development, statistical analysis,
Clinical Studies, regulatory affairs, and product approval and clinical study
regulatory activities (excluding regulatory activities directed to obtaining
pricing and reimbursement approvals). Development shall not include any activities
related to Manufacturing.

 

Section 1.11           “Development Costs”.  Development Costs shall mean all internal and
external costs incurred after the Effective Date in performing the Core
Development Plan or the Supplemental Development Plan, as the case may be, in
accordance with this Agreement.

 

Section 1.12           “Diligent Efforts”.  Diligent Efforts shall mean, with respect to
the Product, the carrying out of obligations in a commercially reasonable,
diligent and sustained manner using efforts not less than the efforts a Party
devotes to a product of similar market potential, profit potential or strategic
value, at a similar stage of its product life and based on conditions then
prevailing, but excluding consideration of any obligation to the other Party
under this Agreement.

 

Section 1.13           “Distributor”.  Distributor shall mean, with respect to a
Party, a Third Party distributor of such Party with respect to the Product that
is not a Related Party of such Party.

 

Section 1.14           “Dyax Intellectual Property”.  Dyax Intellectual Property shall mean Dyax
Know-How and Dyax Patent Rights, collectively.

 

Section 1.15           “Dyax Know-How”.  Dyax Know-How shall mean any Know-How that (a)
[*****] is Controlled by Dyax
on the Effective Date [*****] and
(b) is [*****] for the Development,
Manufacture and/or Commercialization of the Product in the Field as
contemplated by this Agreement.

 

Section 1.16           “Dyax Patent Rights”.  Dyax Patent Rights shall mean Patent Rights,
including Dyax’s rights in Joint Patent Rights, that (a) Cover Dyax Know-How
and (b) are Controlled by Dyax on the Effective Date or come within Dyax’s
Control during the Term, including without limitation, the Existing Dyax Patent
Rights and the Fovea-Assigned Patent Rights.

 

Section 1.17           “Dyax Territory”.  Dyax Territory shall mean all countries of
the world other than the Fovea Territory.

 

Section 1.18           “EMEA”.  EMEA shall mean the European Medicines Agency
or any successor agency thereto.

 

Section 1.19           “European Union” or “EU”.  European Union or EU shall mean the countries
of the European Union, as it is constituted as of the Effective Date and as it
may be expanded from time to time.

 

Section 1.20           “Executive Officers”.  Executive Officers shall mean the Chief
Executive Officer of Dyax (or a senior executive officer of Dyax designated by
Dyax’s Chief Executive Officer) and the Chief Executive Officer of Fovea (or a
senior executive officer of Fovea designated by Fovea’s Chief Executive
Officer).

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

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Section 1.21           “FDA”.  FDA shall mean the United States Food and
Drug Administration or any successor agency thereto.

 

Section 1.22           “Field”.  Field shall mean the use in humans of a
pharmaceutical product as a therapeutic for ophthalmic diseases or conditions.

 

Section 1.23           “Finished Product”.  Finished Product shall mean the finished
Product formulation containing API Bulk Drug Substance filled into unit
packages for final labeling and packaging.

 

Section 1.24           “First Commercial Sale”.  First Commercial Sale shall mean, with
respect to the Product in a country, the first commercial sale of the Product
in such country.  Sales for test
marketing, Clinical Study purposes or compassionate, named patient or similar
use shall not constitute a First Commercial Sale.

 

Section 1.25           “Fovea Intellectual Property”.  Fovea Intellectual Property shall mean Fovea
Know-How and Fovea Patent Rights, collectively, and shall specifically exclude
the Fovea-Assigned Intellectual Property.

 

Section 1.26           “Fovea Know-How”.  Fovea Know-How shall mean any Know-How that (a)
either is Controlled by Fovea on the Effective Date [*****] and (b) is [*****]
the Development, Manufacture and/or Commercialization of the Product in
the Field as contemplated by this Agreement. 
Fovea Know-How shall specifically exclude Know-How included in the
Fovea-Assigned Intellectual Property.

 

Section 1.27           “Fovea New Outside IP”.  Fovea New Outside IP shall mean that portion
of Fovea Know-How, Fovea Patent Rights and/or Fovea Product Intellectual
Property that is not owned by Fovea but comes within Fovea’s Control at any
time after the Effective Date during the Term.

 

Section 1.28           “Fovea Patent Rights”.  Fovea Patent Rights shall mean Patent Rights,
including Fovea’s rights in Joint Patent Rights, that (a) Cover Fovea Know-How
and (b) are Controlled by Fovea on the Effective Date or come within Fovea’s
Control during the Term.   Fovea Patent
Rights shall specifically exclude Fovea-Assigned Patent Rights.

 

Section 1.29           “Fovea Product Intellectual
Property”.  Fovea Product
Intellectual Property shall mean (a) any Know-How that (i) either is Controlled
by Fovea on the Effective Date or comes within Fovea’s Control during the Term,
including Fovea’s rights in Joint Know-How and Fovea Sole Inventions and (ii) that
is produced, generated, conceived and/or reduced to practice as a result of
Fovea’s Development, Manufacture, Commercialization of the Product or use of
the Compound, or that is otherwise used by Fovea in the Development,
Manufacture or Commercialization of the Product, and (b) Patent Rights,
including Fovea’s rights in Joint Patent Rights, that Cover the Fovea Know-How
described in the foregoing clause (a) and are Controlled by Fovea on the
Effective Date or come within Fovea’s Control during the Term. Fovea Product
Intellectual Property shall specifically exclude the Fovea-Assigned
Intellectual Property.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

4

 

Section 1.30           “Fovea Territory”.  Fovea Territory shall mean (i) all member
states of the European Union as constituted on the Effective Date, (ii) those
countries listed on Exhibit H hereto and (iii) any country that is not
within the scope of the foregoing clauses (i) and (ii) that becomes a member
state of the European Union at any time after the Effective Date, provided
that, at the time any such country referred to in this clause (iii) becomes a
member state of the European Union, the inclusion of such country in the Fovea
Territory would not violate or breach any contractual obligation of Dyax to any
Third Party under any agreement that is in effect at the time such country
becomes a member state of the European Union.

 

Section 1.31           “Fully Allocated Supply Cost”.  Fully Allocated Supply Cost shall mean with
respect to API Bulk Drug Substance and/or Finished Product, as the case may be,
the manufacturing Party’s internal and external costs, determined in accordance
with GAAP, as consistently applied by such manufacturing Party in the ordinary
course of its business, incurred in Manufacturing and/or acquiring such API
Bulk Drug Substance and/or Finished Product (including but not limited to the
following activities during the Term: 
process development and validation, manufacturing scale-up and
improvements, stability and other product testing and development activities
relating to quality assurance and quality control, regulatory affairs
activities and product liability insurance), which costs shall include, without
limitation (a) the cost of goods produced, which cost shall include [*****] and/or (b) any other costs
borne by the manufacturing Party for the [*****].

 

Section 1.32           “GAAP”.  GAAP shall mean United States generally
accepted accounting principles.

 

Section 1.33           “Generic
Competition”.  Generic Competition
shall mean, with respect to a Product in a given country in a given calendar
quarter, if, during such calendar quarter, one or more Generic Products shall
be commercially available in such country and such Generic Products [*****].

 

Section 1.34           “Generic
Product”.  Generic Product shall mean
any pharmaceutical product sold by any Person for use in the Field (other than
sales of the Product by either Party or its Related Parties in accordance with
the terms of this Agreement, whether as a branded product or a generic product)
that contains [*****].  For purposes of this Section 1.33, another
compound will be considered to [*****].

 

Section 1.35           “IND”.  IND shall mean an Investigational New Drug
Application filed with FDA or a similar application to conduct Clinical Studies
filed with an applicable Regulatory Authority outside of the United States.

 

Section 1.36           “In-License”.  In-License shall mean an agreement between a
Party and a Third Party pursuant to which such Party has (i) pursuant to Section
2.9, licensed Blocking Third Party Patent Rights with the approval of the JSC,
or (ii) pursuant to Section 2.8, licensed with the approval of the JSC,
Technology owned or controlled by a Collaborator that is to be used in the
Development, Manufacture or Commercialization of the Initial Finished Product
subject to, and in accordance with, the terms of this Agreement.   Without limiting the generality of the
foregoing definition, the [*****] License
Agreement shall not be treated for purposes of this Agreement as an In-License.

 

Section 1.37           “Invention”.  Invention shall mean any Know-How that is
conceived, reduced to practice and/or developed in the course of performance of
activities pursuant to this Agreement.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

5

 

Section 1.38           “Joint Intellectual Property”.  Joint Intellectual Property shall mean Joint
Know-How and Joint Patent Rights, collectively.

 

Section 1.39           “Joint Know-How”.  Joint Know-How shall mean any Know-How that
is developed or acquired jointly by the Parties in connection with their
activities pursuant to this Agreement, including Joint Inventions.

 

Section 1.40           “Joint Patent Rights”.  Joint Patent Rights shall mean Patent Rights
that Cover Joint Inventions.

 

Section 1.41           “Know-How”.  Know-How shall mean any information and
materials, whether proprietary or not and whether patentable or not, including
without limitation ideas, concepts, inventions, formulas, methods, protocols,
procedures, knowledge, know-how, trade secrets, processes, assays, skills,
experience, techniques, designs, compositions, plans, documents, results of
experimentation and testing, including without limitation, pharmacological,
toxicological, and pre-clinical and clinical test data and analytical and
quality control data, improvements, discoveries, works of authorship, compounds
and biological materials.

 

Section 1.42           “Major European Countries”.  Major European Countries shall mean the
collective reference to the United Kingdom, France, Germany, Italy and Spain.

 

Section 1.43           “Manufacturing” or “Manufacture”.  Manufacturing or Manufacture shall mean
activities directed to producing, manufacturing, processing, filling,
finishing, packaging and labeling a product.

 

Section 1.44           “Net Sales”.  “Net Sales” shall mean, with respect to the
Product, the gross invoiced sales of the Product by the Royalty Payor and its
Related Parties to Third Parties that are not Related Parties of the Royalty
Payor, less the following deductions to the extent included in the gross
invoiced sales price for the Product or otherwise directly paid or incurred by
such Royalty Payor or its Related Parties with respect to the sale of the
Product:

 

[*****]

 

Notwithstanding the foregoing, in any case where the
Product is sold or otherwise disposed of in a transaction that is not an arm’s
length sale of the Product exclusively for cash that is separate from any sale
or disposition of other products or of services, Net Sales shall mean the
greatest of:

 

[*****]

 

With respect to sales of
Product that is comprised of Compound combined with any other clinically active
ingredient or a device (a “Combination Product”), Net Sales shall be
calculated on the basis of [*****].   In the event that the Product is sold only
as a Combination Product and not sold without other clinically active
ingredients or a device, the Parties shall negotiate in good faith another
basis on which to calculate Net Sales with respect to a Combination Product
that fairly reflects the value of the Product relative to the other clinically
active ingredients and/or device in the Combination Product, but in no event
shall such calculation result in the [*****].
Notwithstanding anything express or implied in the provisions of the 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

6

 

foregoing two sentences, in
no event shall such provisions be applicable in the event that the use of such
other clinically active ingredient or device in any such Combination Product is
pursuant to an In-License entered into by either Party pursuant to, and in
accordance with, the provisions of Section 2.8 or Section 2.9 hereof.

 

A
percentage of the deductions set forth in paragraphs (a) through (d) above
equal to the ratio of the Net Sales for the Product to the Net Sales of the
entire Combination Product will be applied in calculating Net Sales for a
Combination Product.

 

Section 1.45           “Other Related Dyax Licensee”.  Other Related Dyax Licensee shall mean a
Third Party to whom Dyax has granted a license or sublicense under the Dyax
Intellectual Property, the Fovea Intellectual Property and/or Fovea Product
Intellectual Property, as the case may be, to Develop, Manufacture and/or
Commercialize the Compound or any product containing the Compound (but not, in
any such case, the Product).  For clarity,
any Third Party that is an Other Related Dyax Licensee may also be a Related
Party of Dyax if such Third Party meets the definition of Related Party.

 

Section 1.46           “Parties”.  Parties shall mean Dyax and Fovea.

 

Section 1.47           “Party”.  Party shall mean either Dyax or Fovea.

 

Section 1.48           “Patent Rights”.  Patent Rights shall mean patents and patent
applications and all substitutions, divisions, continuations,
continuations-in-part, reissues, reexaminations and extensions thereof, and all
counterparts thereof in any country.

 

Section 1.49           “Person”.  Person shall mean any natural person,
corporation, firm, business trust, joint venture, association, organization,
company, partnership or other business entity, or any government, or any agency
or political subdivisions thereof.

 

Section 1.50           “Phase I Clinical Study”.  Phase I Clinical Study shall mean a clinical
study of the Product in human volunteers or patients with the endpoint of
determining initial tolerance, toxicity, safety and/or pharmacokinetic
information, which shall be deemed commenced when the third volunteer or
patient in such study has received his or her initial dose of the Product.

 

Section 1.51           “Phase II Clinical Study”.  Phase II Clinical Study shall mean a
preliminary efficacy and safety or dose ranging human clinical study of the
Product in the target patient population, which shall be deemed commenced when
the third patient in such study has received his or her initial dose of the
Product.

 

Section 1.52           “Phase III Clinical Study”.  Phase III Clinical Study shall mean a human
clinical study to confirm with statistical significance the efficacy and safety
of the Product performed to obtain Regulatory Approval for the Product in any
country, which shall be deemed commenced when the third patient in such study
has received his or her initial dose of the Product.

 

Section 1.53           “Post-Approval Study”.  Post-Approval Study shall mean a clinical
study initiated in a country after receipt of Regulatory Approval for the
Product in such country.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

7

 

 

Section 1.54           “Product”.  Product shall mean a product containing or
consisting of the Compound for use solely by intra-vitreous delivery via
injection.  The definition of Product is
subject to expansion pursuant to, and in accordance with, Section 3.1(g) hereof.

 

Section 1.55           “Product Trademark(s)”.  Product Trademark(s) shall mean the trademark(s)
and service mark(s) as may be proposed by Fovea and approved by the JSC for use
in connection with the distribution, marketing, promotion and sale of the
Product in the Fovea Territory, and/or accompanying logos, trade dress and/or
indicia of origin.

 

Section 1.56           “[*****] License Agreement”.  [*****]
License Agreement shall mean the License Agreement effective April 3,
1997 between [*****] and Dyax.

 

Section 1.57           “[*****] Patent Rights”. 
[*****] Patent Rights
shall mean the Patent Rights listed on Exhibit C-3, which have been licensed to
Dyax under the [*****] License
Agreement.

 

Section 1.58           “Regulatory Approval”.  Regulatory Approval shall mean the approval
of the applicable Regulatory Authority necessary for the marketing and sale of
the Product for a particular indication in a country, excluding separate
pricing and/or reimbursement approvals that may be required.

 

Section 1.59           “Regulatory Authority”.  Regulatory Authority shall mean any federal,
national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity with authority over the
marketing and sale of a pharmaceutical product in a country, including without
limitation FDA in the United States and EMEA in the EU.

 

Section 1.60           “Related Party”.  Related Party shall mean a Party’s Affiliates
and permitted Sublicensees; provided that the term Related Party includes only
those distributors whose obligations to such Party or Affiliate include
responsibility for sales and/or marketing efforts for and on behalf of such
Party in a country of the Territory with respect to the Product or sharing of
costs and expenses with respect to sales and/or marketing of the Product on
behalf of a Party or its Affiliates, and does not include distributors of such
Party or its Affiliates who purchase Product from such Party or its Affiliates
in an arm’s length transaction and who have no sales or marketing obligation
for and on behalf of such Party or its Affiliates with respect to the
Product.  For clarity, Fovea and its
Affiliates shall not be deemed Related Parties of Dyax and Dyax and its
Affiliates shall not be deemed Related Parties of Fovea.

 

Section 1.61           “Royalty Payor”.  Royalty Payor shall mean the Party obligated
to make royalty or other relevant payments under this Agreement to the other
Party.

 

Section 1.62           “Royalty Recipient”.  Royalty Recipient shall mean the Party
entitled to receive royalty and other relevant payments under this Agreement
from the other Party.

 

Section 1.63           “Sublicensee”.  Sublicensee shall mean a Third Party to whom
a license or sublicense under any Dyax Intellectual Property, Fovea
Intellectual Property and/or Fovea Product Intellectual Property, as the case
may be, has been granted pursuant to, and in full compliance with all
applicable provisions of, this Agreement, to Develop, Manufacture and/or
Commercialize the Product, or otherwise grants rights to distribute, promote or
sell the Product.  For purposes of
clarification, and without limiting the forgoing provisions of this definition,
a Sublicensee shall include, for purposes of this 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

8

 

Agreement, (i) a Third Party to whom Dyax, in
full compliance with all applicable provisions of this Agreement, grants a
license or sublicense under Dyax Intellectual Property to Develop, Manufacture
and/or Commercialize the Product and (ii) a Third Party to whom Fovea, in full
compliance with all applicable provisions of this Agreement, grants a license
or sublicense under Fovea Intellectual Property and/or Fovea Product
Intellectual Property to Develop, Manufacture and/or Commercialize the
Product.  Notwithstanding the foregoing,
a Distributor shall not be deemed or treated, for purposes of this Agreement,
as a Sublicensee.

 

Section 1.64           “Territory”.  Territory shall mean with respect to (a) Fovea,
the Fovea Territory and (b) Dyax, the Dyax Territory.

 

Section 1.65           “Third Party”.  Third Party shall mean any Person other than
a Party or any of its Affiliates.

 

Section 1.66           “Transfer Price”.
Transfer Price shall mean for (a) API Bulk Drug Substance supplied to Fovea for
use in [*****]; (b) API Bulk
Drug Substance supplied to Fovea for use in [*****]; (c) Finished Product supplied to Dyax for use in [*****]; and (d) Finished Product
supplied to Dyax for [*****].  In the event that (i) either Party is not
Manufacturing API Bulk Drug Substance or Finished Product, as the case may be,
but a Related Party of such Party is acting on behalf of such Party, or an
Other Related Dyax Licensee is acting on behalf of Dyax, under Article VI
hereof to Manufacture and supply API Bulk Drug Substance or Finished Product,
as the case may be, or (ii) either Party has granted to a Related Party any
right of such Party to obtain supply of API Bulk Drug Substance or Finished
Product, as the case may be, from the other Party pursuant to, and in
accordance with, Article VI hereof, then any reference in this definition to
such Party shall be deemed to be a reference to such Related Party or such
Other Related Dyax Licensee, as the case may be.

 

Section 1.67           “United States”.  United States shall mean the United States of
America and its territories and possessions.

 

Section 1.68           “Valid Claim”.  Valid Claim shall mean a claim (a) of any
issued, unexpired patent that has not been revoked or held unenforceable or
invalid by a decision of a court or governmental agency of competent
jurisdiction from which no appeal can be taken, or with respect to which an
appeal is not taken within the time allowed for appeal, and that has not been
disclaimed or admitted to be invalid or unenforceable through reissue,
disclaimer or otherwise or (b) of any patent application that has not been
cancelled, withdrawn or abandoned or been pending for [*****].

 

Section 1.69           Additional Definitions.  Each of the following definitions is set
forth in the Section of this Agreement indicated below:

 

	
  Definition

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  1974
  Convention

  	
   

  	
  13.1

  
	
  AAA

  	
   

  	
  12.3(a)

  
	
  Agreement

  	
   

  	
  Preamble

  
	
  Alliance
  Manager

  	
   

  	
  2.6

  

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

9

 

	
  Bankruptcy
  Code

  	
   

  	
  11.2(e)

  
	
  Breaching
  Party

  	
   

  	
  11.2(b)

  
	
  Challenging
  Party

  	
   

  	
  11.2(d)

  
	
  Collaborator

  	
   

  	
  2.8

  
	
  Competitive
  Infringement

  	
   

  	
  8.4(a)

  
	
  Confidential
  Information

  	
   

  	
  9.1

  
	
  Controlling
  Party

  	
   

  	
  8.3(a)

  
	
  Core
  Development Plan

  	
   

  	
  4.2(a)

  
	
  Core
  Dyax Patent Rights

  	
   

  	
  8.3(a)

  
	
  Dyax

  	
   

  	
  Preamble

  
	
  Dyax
  Indemnified Party

  	
   

  	
  10.10(a)

  
	
  Dyax
  Sole Inventions

  	
   

  	
  8.2(a)

  
	
  Dyax
  Supply Agreement

  	
   

  	
  6.3(a)

  
	
  Effective
  Date

  	
   

  	
  Preamble

  
	
  EU
  Commercialization Opportunity

  	
   

  	
  3.1(f)

  
	
  Existing
  Dyax Patent Rights

  	
   

  	
  10.7(b)

  
	
  Fovea

  	
   

  	
  Preamble

  
	
  Fovea-Assigned
  Intellectual Property

  	
   

  	
  8.1

  
	
  Fovea-Assigned
  Patent Rights

  	
   

  	
  10.8(a)

  
	
  Fovea
  Indemnified Party

  	
   

  	
  10.10(b)

  
	
  Fovea
  Sole Inventions

  	
   

  	
  8.2(a)

  
	
  Fovea
  Supply Agreement

  	
   

  	
  6.3(a)

  
	
  Fovea
  Trademarks

  	
   

  	
  8.8(b)

  
	
  Global
  Trademarks

  	
   

  	
  8.8(b)

  
	
  Indemnified
  Party

  	
   

  	
  10.10(c)(i)

  
	
  Indemnifying
  Party

  	
   

  	
  10.10(c)(i)

  
	
  Initial
  Enforcement Rights Party

  	
   

  	
  8.4(c)

  
	
  Initial
  Finished Product

  	
   

  	
  2.8

  
	
  Initial
  Notice

  	
   

  	
  3.1(f)

  
	
  Joint
  Inventions

  	
   

  	
  8.2(b)

  
	
  JSC

  	
   

  	
  2.1(a)

  
	
  Losses

  	
   

  	
  10.10(a)

  
	
  Non-Breaching
  Party

  	
   

  	
  11.2(b)

  
	
  Prosecuting
  Party

  	
   

  	
  8.3(d)

  
	
  [*****]

  	
   

  	
  1.54

  
	
  Royalty
  Term

  	
   

  	
  7.1(d)

  
	
  [*****]

  	
   

  	
  4.2(a)

  
	
  Promotional
  Materials

  	
   

  	
  5.3

  
	
  Research
  and Option Agreement

  	
   

  	
  Introduction

  
	
  Secondary
  Enforcement Rights Party

  	
   

  	
  8.4(c)

  
	
  Severed
  Clause

  	
   

  	
  13.3

  
	
  Sole
  Inventions

  	
   

  	
  8.2(a)

  
	
  Specifications

  	
   

  	
  Exhibit
  E

  
	
  Supplemental
  Development Plan

  	
   

  	
  4.2(a)

  
	
  Supply
  Agreement

  	
   

  	
  6.3(a)

  

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

10

 

	
  Technology

  	
   

  	
  2.8

  
	
  Term

  	
   

  	
  11.1

  
	
  Third
  Party Collaboration Agreements

  	
   

  	
  2.8

  
	
  Working
  Group

  	
   

  	
  2.2

  

 

ARTICLE
II

MANAGEMENT
OF AGREEMENT ACTIVITIES

 

Section 2.1            Joint Steering Committee.

 

(a)           Formation; Purposes and Principles.  Within ten days after the Effective Date,
Dyax and Fovea shall establish a joint steering committee (the “JSC”),
which shall have overall responsibility for the oversight of the Parties’
activities under this Agreement.

 

(b)           Specific Responsibilities.  In addition to its overall responsibility for
such oversight as is established by this Agreement, the JSC shall in
particular:

 

(i)            review and monitor the
clinical and regulatory program of Fovea under the Core Development Plan;

 

(ii)           annually review and approve
updates by Fovea to the Core Development Plan, including without limitation,
the Clinical Study endpoints, clinical methodology and monitoring requirements
for the Clinical Studies described in the Core Development Plan;

 

(iii)          review, discuss and comment
on the Parties’ annual Commercialization plans pursuant to, and in accordance
with, Section 5.2 hereof;

 

(iv)          review, discuss and comment
on the clinical and regulatory program of Dyax under any Supplemental
Development Plan provided by Dyax;

 

(v)           annually review, discuss and
comment on updates by Dyax to any Supplemental Development Plan;

 

(vi)          review, discuss and comment
on each Party’s strategy to seek and obtain Regulatory Approval of the Product,
as well as, to the extent consistent with applicable law, related pricing and
reimbursement approvals, in the Territory of such Party;

 

(vii)         review and monitor each
Party’s progress in seeking and obtaining Regulatory Approval of the Product,
as well as related pricing and reimbursement approvals, in the Territory of
such Party;

 

(viii)        review, discuss and comment
on each Party’s annual Commercialization plan and budget and the Commercialization
program and activities of such Party; and

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

11

 

(ix)           perform such other functions
as are expressly provided for elsewhere in this Agreement or as are appropriate
to further the purposes of this Agreement as determined by the Parties,
including periodic evaluations of performance against goals.

 

Section 2.2             Working Groups.  From time to time, the JSC may establish
working groups (each, a “Working Group”) to oversee particular projects
or activities, and each such Working Group shall be constituted and shall
operate as the JSC determines.

 

Section 2.3             Membership.  Each of the JSC and any Working Groups shall
be composed of an equal number of representatives appointed by each of Dyax and
Fovea.  The JSC shall initially have
three (3) representatives of each Party, but the JSC may change the size of the
JSC from time to time by mutual consent of the members of the JSC.  Each Party may replace its JSC and Working
Group representatives at any time upon written notice to the other Party. The
JSC shall be chaired first by a representative of [*****] for the period from the Effective Date [*****], and thereafter the
chairperson position shall rotate [*****]
on every other [*****],
with Fovea to appoint the chairpersons for the second two-year term, and so
forth thereafter.  The chairperson shall
be responsible for calling meetings, preparing and circulating an agenda in
advance of each meeting, and preparing and issuing minutes of each meeting
within [*****] thereafter.

 

Section 2.4             Decision-Making.  The JSC and any Working Group shall [*****].  With respect to decisions of the JSC and any
Working Group, the representatives of each Party shall have collectively one
vote on behalf of such Party.  Should the
members of a Working Group maintain their disagreement on any matter [*****], the matter shall be referred
to [*****] for resolution.  [*****]

 

Section 2.5             Meetings of the JSC and
Working Groups.  The JSC and
any Working Groups shall hold meetings at such times as the JSC shall
determine, but in no event shall such meetings of the JSC be held less
frequently than [*****].  The JSC and any Working Groups shall meet
alternately at Dyax’s facilities in Cambridge, Massachusetts and Fovea’s
facilities in Paris, France or at such locations as the Parties may otherwise
agree.  Other representatives of each
Party or, with approval of the JSC and subject to confidentiality and non-use
provisions which are no less stringent than those set forth in Article IX of
this Agreement, representatives of Third Parties involved in the Development,
Manufacture or Commercialization of the Product in the Field, may attend
meetings of the JSC or such Working Group as nonvoting observers.  Meetings of the JSC and any Working Groups
may be held by audio or video teleconference with the consent of each
Party.  Each Party shall be responsible
for all of its own expenses of participating in the JSC and any Working Groups.  No action taken at a meeting of the JSC or a
Working Group shall be effective unless a representative of each Party is
present or participating.

 

Section 2.6             Alliance Managers.  Each Party shall designate a single alliance
manager (“Alliance Manager”) for all of the activities contemplated under this
Agreement.  Such alliance managers will
be responsible for the day-to-day worldwide coordination of the activities
contemplated by this Agreement and will serve to facilitate communication
between the Parties.  Such alliance
managers shall have experience and knowledge appropriate for managers with such
project management responsibilities. 
Each Party may change its designated alliance manager from time to time
upon notice to the other Party.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

12

 

Section 2.7             Third Party Performance of
Agreement Activities.    Fovea shall be entitled to utilize the
services of Third Parties (including Third Party contract research
organizations, Third Party contract manufacturing organizations (“CMOs”) and
Third Party contract sales organizations (“CSOs”)) to perform its Development
activities under the Core Development Plan or to Develop, Manufacture and
Commercialize the Product in the Field subject to, and in accordance with, the
provisions of this Agreement and the Supply Agreements; provided that (i) except for CMOs being
used by Fovea as a result of a supply default of Dyax under Article VI hereof,
Dyax shall have the right to approve, such approval to not be unreasonably
withheld or delayed, any such CMOs or CSOs and (ii) Fovea shall remain at all
times fully liable for its responsibilities under the Core Development Plan,
this Agreement and the Supply Agreements. 
Fovea shall not use Third Party contract resources to conduct part or
all of its obligations under the Core Development Plan, this Agreement or any
Supply Agreement unless Fovea’s rights under the agreement with the Third Party
guarantee Dyax the same rights under this Agreement or the applicable Supply
Agreement, as the case may be, as if Fovea had done the work itself, and any
such Third Party agreement shall include confidentiality and non-use provisions
which are no less stringent than those set forth in Article IX of this
Agreement.  Dyax shall be entitled to
utilize the services of Third Parties (including Third Party contract research
organizations, Third Party contract manufacturing organizations and Third Party
contract sales organizations) to Develop, Manufacture and Commercialize the
Product subject to, and in accordance with, the provisions of this Agreement
and the Supply Agreements; provided
that Dyax shall remain at all times fully liable for its responsibilities under
this Agreement and the Supply Agreements. 
Dyax shall not use Third Party contract resources to conduct part or all
of its obligations under this Agreement or any Supply Agreement unless Dyax’s
rights under the agreement with the Third Party guarantee Fovea the same rights
under this Agreement or the applicable Supply Agreement, as the case may be, as
if Dyax had done the work itself, and any such Third Party agreement shall
include confidentiality and non-use provisions which are no less stringent than
those set forth in Article IX of this Agreement.

 

Section 2.8             Third Party Technology.  The Parties agree that it may be necessary or
desirable to enter into agreements with Third Parties (“Collaborators”) to
obtain technology, information, materials, data or know-how, patentable or
otherwise, (“Technology”) in order to allow Fovea to manufacture, formulate
and/or deliver the initial Finished Product for [*****] and/or to perform its obligations under the Core
Development Plan with respect to the Initial Finished Product (such Third Party
agreements being hereinafter referred to, collectively, as the “Third Party
Collaboration Agreements”).  Such Third
Party Collaboration Agreements shall not conflict with the terms and conditions
of this Agreement or either Supply Agreement. 
In the event that any such Third Party Collaboration Agreements are
contemplated in connection with the activities described in the Core
Development Plan, the JSC shall discuss, subject to Third Party confidentiality
obligations, and agree upon whether or not to enter into such Third Party
Collaboration Agreements, and the Core Development Plan and/or any and all
applicable Supplemental Development Plans shall be amended to include actions
required related to any such Technology, as relevant.  [*****]

 

Section 2.9             In-Licenses of Blocking
Third Party Patent Right; Compliance with In-Licenses.

 

[*****]

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

13

 

 

Section 2.10          Exchange of Information.  In accordance with and subject to the terms
of Article IX, on an ongoing basis during the Term:

 

(a)           Dyax shall disclose to Fovea all Dyax Intellectual
Property that has not been previously disclosed and shall update such
disclosure [*****].

 

(b)           Fovea shall disclose to Dyax all Fovea Intellectual
Property and all Fovea Product Intellectual Property that has not been
previously disclosed and shall update such disclosure at least semi-annually.

 

(c)           Fovea shall make available its employees,
consultants and subcontractors engaged in the performance of its Development,
Manufacturing and Commercialization obligations under this Agreement as may be
reasonably necessary to consult with Dyax with respect to such activities, upon
reasonable notice during normal business hours as coordinated through the
Alliance Managers and the JSC.

 

(d)           Dyax shall provide Fovea with such assistance and
access to its employees, consultants and subcontractors as may be reasonably
necessary to assist Fovea in the performance of Fovea’s Development,
Manufacturing and Commercialization obligations under this Agreement, upon
reasonable notice during normal business hours as coordinated through the
Alliance Managers and the JSC.

 

ARTICLE III

LICENSE GRANTS

 

Section 3.1            Dyax Grants.

 

(a)           Subject to the terms and
conditions of this Agreement, Dyax hereby grants to Fovea a co-exclusive (with
Dyax) right and license, with the right to grant sublicenses solely as set
forth in Section 3.1(e) below, under Dyax Intellectual Property, to Develop the
Product in the Field as set forth in this Agreement.  Except pursuant to, and in accordance with,
this Agreement, during the Term none of Dyax, its Related Parties or the Other
Related Dyax Licensees shall Develop, or grant to any Third Party the right to
Develop, the Product for Commercialization or use in the Field in any country
of the Fovea Territory.

 

(b)           Subject to the terms and
conditions of this Agreement, Dyax hereby grants to Fovea an exclusive right
and license (including with respect to Dyax), with the right to grant
sublicenses solely as set forth in Section 3.1(e) below, under Dyax
Intellectual Property, to Commercialize the Product in the Field in the Fovea
Territory.   Consistent with the license
granted by Dyax to Fovea pursuant to this Section 3.1(b), during the Term none
of Dyax, its Related Parties or the Other Related Dyax Licensees shall
Commercialize, or grant to any Third Party the right to Commercialize, the
Product in the Field in any country in the Fovea Territory.  Fovea shall have no rights hereunder to
Develop or Commercialize, or to grant any Third Party the right to Develop or
Commercialize, the Product outside the Field in any country.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

14

 

(c)           Subject to the terms and
condition of this Agreement, Dyax hereby grants to Fovea a non-exclusive right
and license, with the right to grant sublicenses solely as set forth in Section
3.1(e) below, under Dyax Intellectual Property, to Manufacture Product for use
in the Field, provided that Fovea will not exercise any of its rights
granted under this Section 3.1(c) except to the extent permitted pursuant to,
and in accordance with, Article VI hereof. 
During the Term, none of Dyax, its Related Parties or the Other Related
Dyax Licensees shall Manufacture, or grant to any Third Party the right to
Manufacture, the Product for use, sale or Commercialization in the Field in any
country in the Fovea Territory, except if and to the extent otherwise expressly
provided and permitted pursuant to, and in accordance with, Article VI hereof.

 

(d)           The licenses granted by Dyax
to Fovea in Sections 3.1(a), (b) and (c), to the extent that they include any
sublicense of any In-License of Dyax or of any other in-license of Third Party
intellectual property entered into after the Effective Date, are, in all
respects, subject to and limited by the terms of such In-License or other in-license,
as the case may be.  Dyax hereby
represents and warrants to Fovea that the rights and obligations of Fovea set
forth in this Agreement do not contravene nor are they inconsistent with or in
conflict with the terms of any in-license of Dyax that is in effect as of the
Effective Date and that is being sublicensed to Fovea pursuant to any of the
foregoing provisions of this Section 3.1. 
During the Term, Dyax shall not enter into any In-License or other
in-license of Third Party intellectual property having terms that would
contravene or be inconsistent or in conflict with the rights of Fovea under
this Agreement.  During the Term, Dyax
shall not amend, modify or terminate any In-License or other in-license of Third
Party intellectual property (including, without limitation, any such in-license
that is in effect as of the Effective Date) without the prior written consent
of Fovea (which may be granted or withheld by Fovea in its absolute discretion)
if such amendment, modification or termination would materially adversely
affect any of the rights that Fovea would have under this Agreement if such
amendment, modification or termination were not effected.

 

(e)           Fovea shall be entitled to grant sublicenses under
the licenses granted in Section 3.1(a), (b) and (c) to Affiliates and Third
Parties (including, without limitation, the right to grant further
sublicenses); provided, however, that any sublicense to a Third
Party shall be subject to Dyax’s prior written approval, not to be unreasonably
withheld or delayed.  Notwithstanding the
foregoing provisions of this Section 3.1(e) expressed or implied to the
contrary, (i) Dyax’s prior written approval shall not be required in connection
with any grant to a Third Party of a sublicense under the license granted in Section
3.1(c) if and to the extent such sublicense without Dyax’s prior written
approval is permitted pursuant to Article VI hereof, (ii) Dyax’s prior written
consent shall not be required in connection with any grant to a Third Party of
a sublicense under the license granted in Section 3.1(b) for the sole purpose
of allowing such Third Party to act as a Distributor of the Product in the
Field in the Fovea Territory and for no other purpose and (iii) in the event
that the exercise by Fovea of any of its rights under Section 2.7 hereof in
accordance with their respective terms as set forth thereunder shall require
that Fovea grant to a Third Party a sublicense under the licenses granted under
any of Section 3.1(a), (b) or (c), then Fovea shall be entitled to grant such
sublicenses, solely to the extent so required, without the prior written
approval of Dyax.

 

(f)            Each permitted sublicense under Section 3.1(e) shall
be in writing, shall not contravene or be inconsistent or in conflict with the
terms and conditions of this Agreement and shall include provisions (i) requiring
the applicable Sublicensee to acknowledge and agree that such sublicense 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

15

 

is subject to the applicable license(s) granted hereunder and to the
terms and conditions of this Agreement, (ii) requiring the applicable
Sublicensee to perform all applicable obligations of Fovea hereunder,
including, without limitation, any grant-back
licenses, indemnification obligations and the obligation to make reports
and keep and maintain records of sales to at least the same extent as required
of Fovea under this Agreement, and (iii) allowing Dyax the same access and
audit rights with respect to such records as permitted with respect to Fovea’s
records hereunder.  Fovea shall at all
times remain responsible for the performance of its Sublicensees.  Fovea shall provide, or cause to be provided,
a copy of each such sublicense to Dyax promptly following execution, which may
be reasonably redacted with respect to terms and conditions not relevant to
determining compliance with this subsection (f), and with respect to financial
terms.

 

(g)           Fovea shall have the right, exercisable at any time
during the Term, to request that the definition of Product hereunder be
expanded to include [*****]  Dyax shall negotiate reasonably and in good
faith with Fovea with respect to any such request for a reasonable period of
time not to exceed [*****] after
receipt of written request from Fovea. 
During the Term, none of Dyax, its Related Parties or the Other Related
Dyax Licensees shall Develop or Commercialize, or grant to any Third Party the
right to Develop or Commercialize, the Compound (or any product containing the
Compound) for [*****].

 

Section 3.2            Fovea Grants.

 

(a)           Subject to the terms and conditions of this
Agreement, Fovea hereby grants to Dyax a co-exclusive (with Fovea) right and
license, with the right to grant sublicenses solely as set forth in Section 3.2(f)
below, under Fovea Intellectual Property and Fovea Product Intellectual
Property, to Develop the Product in the Field as set forth in this
Agreement.  Except pursuant to, and in
accordance with, this Agreement, during the Term none of Fovea or its Related
Parties shall Develop, or grant to any Third Party the right to Develop, the
Product for Commercialization or use in any field in any country in the Dyax
Territory, or for Commercialization or use outside the Field in any country in
the Fovea Territory.

 

(b)           Subject to the terms and conditions of this
Agreement, Fovea hereby grants to Dyax (i) an exclusive right and license
(including with respect to Fovea), with the right to grant sublicenses solely
as set forth in Section 3.2(f) below, under Fovea Intellectual Property and
Fovea Product Intellectual Property, to Commercialize the Product in the Field
in the Dyax Territory and (ii) an exclusive right and license (including with
respect to Fovea), with the right to grant sublicenses solely as set forth in Section
3.2(f) below, under Fovea Product Intellectual Property, to Commercialize the
Product outside the Field in the Dyax Territory.  Consistent with the license granted by Fovea
to Dyax pursuant to this Section 3.2(b), during the Term none of Fovea or its
Related Parties shall Commercialize, or grant to any Third Party the right to
Commercialize, the Product in any field in any country in the Dyax Territory,
or outside the Field in any country in the Fovea Territory.

 

(c)           Subject to the terms and conditions of this
Agreement, Fovea hereby grants to Dyax a non-exclusive right and license, with
the right to grant sublicenses solely as set forth in Section 3.2(f) below,
under Fovea Intellectual Property and Fovea Product Intellectual Property, to
Manufacture 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

16

 

Finished Product, provided that Dyax will not exercise any of
its rights granted under this Section 3.2(c) except to the extent permitted
pursuant to, and in accordance with, Article VI.

 

(d)           Subject to the terms and conditions of this
Agreement, Fovea hereby grants to Dyax a non-exclusive right and license, with
the right to grant sublicenses solely as set forth in Section 3.2(f) below,
under Fovea Product Intellectual Property to Develop, Manufacture and
Commercialize products containing the Compound outside the Field in the Dyax
Territory and/or the Fovea Territory. 
The non-exclusive right and license granted to Dyax pursuant to this Section
3.2(d) shall be fully paid, except to the extent otherwise expressly provided
elsewhere in this Agreement.

 

(e)           The licenses granted by Fovea to Dyax in Sections
3.2(a), (b), (c) and (d), to the extent that they include any sublicense of any
In-License of Fovea or of any other in-license of Third Party intellectual
property after the Effective Date, are, in all respects, subject to and limited
by the terms of such In-License or other in-license.  Fovea hereby represents and warrants to Dyax
that the rights and obligations of Dyax set forth in this Agreement do not
contravene nor are they inconsistent with or in conflict with the terms of any
in-license of Fovea that is in effect as of the Effective Date and that is
being sublicensed to Dyax pursuant to any of the foregoing provisions of this Section
3.2.  During the Term, Fovea shall not
enter into any In-License or other in-license of Third Party intellectual
property having terms that would contravene or be inconsistent or in conflict
with the rights of Dyax under this Agreement. 
During the Term, Fovea shall not amend, modify or terminate any
In-License or other in-license of Third Party intellectual property (including,
without limitation, any such in-license that is in effect as of the Effective
Date) without the prior written consent of Dyax (which may be granted or
withheld by Dyax in its absolute discretion) if such amendment, modification or
termination would materially adversely affect any of the rights that Dyax would
have under this Agreement if such amendment, modification or termination were
not effected.  In addition,
notwithstanding anything expressed or implied in any of the foregoing
provisions of this Section 3.2 or elsewhere in this Agreement to the contrary,
no license is granted by Fovea under Section 3.2(a), (b), (c) or (d) or
elsewhere in this Agreement to use any compound, molecule, pharmaceutical
composition or development or product candidate developed without use of any
Dyax Intellectual Property and owned or Controlled by Fovea as an active
pharmaceutical ingredient in combination with the Compound unless such
combination is the form of the Product being Developed by Fovea pursuant to the
Core Development Plan.

 

(f)            Dyax shall be entitled to grant sublicenses under
the licenses granted in Section 3.2(a), (b), (c) and (d) to Affiliates and
Third Parties (including, without limitation, the right to grant further
sublicenses) without having to obtain the consent or approval of Fovea; provided, however,
that each such sublicense shall be in writing, shall not contravene or be
inconsistent or in conflict with the terms and conditions of this Agreement and
shall include provisions (i) requiring the applicable Sublicensee to
acknowledge and agree that such sublicense is subject to the applicable license(s)
granted hereunder and to the terms and conditions of this Agreement, (ii) requiring
the applicable Sublicensee to perform all applicable obligations of Dyax
hereunder, including, without limitation, any grant-back
licenses, indemnification obligations and the obligation to make reports
and keep and maintain records of sales to at least the same extent as required
of Dyax under this Agreement, and (iii) allowing Fovea the same access and
audit rights with respect to such records as permitted with respect to Dyax’s
records hereunder.  Dyax shall at all
times remain responsible for the performance of its Sublicensees.  Dyax shall provide, or cause to be provided,
a copy of each such sublicense to Fovea promptly following execution, 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

17

 

which may be reasonably redacted with respect to terms and conditions
not relevant to determining compliance with this subsection (f), and with
respect to financial terms.

 

(g)           Notwithstanding anything express or implied in the
foregoing provisions of this Section 3.2 or in any other provisions of this
Agreement to the contrary,  any Fovea New
Outside IP that Fovea Controls and has the right to sublicense to Dyax other
than pursuant to an In-License [*****].

 

(h)           [*****]

 

Section 3.3             Dyax Retained Rights.  Any rights of Dyax not expressly granted to
Fovea, or otherwise expressly restricted or limited, under the provisions of
this Agreement shall be retained by Dyax.  
Without limiting the generality of the immediately preceding sentence,
Dyax shall retain the right, subject to the provisions of Article IX and Section
10.1 hereof, to (a) exploit and license Dyax Intellectual Property to Develop,
Manufacture and Commercialize products containing the Compound within or
outside the Field in the Dyax Territory, without any duty to obtain Fovea’s
consent for such exploitation or license and, except as expressly provided in
this Agreement, with respect to the Development, Manufacture or
Commercialization by Dyax of Products in the Dyax Territory, without any duty
to account to Fovea for such exploitation or license, (b) exploit and license
Dyax Intellectual Property to Develop, Manufacture and Commercialize products
containing the Compound outside the Field in the Fovea Territory, without any
duty to account to Fovea or obtain Fovea’s consent for such exploitation, (c) exploit
Dyax Intellectual Property for purposes unrelated to products containing the
Compound, without any duty to account to Fovea or obtain Fovea’s consent for
such exploitation, and (d) participate in the Development, Manufacture and
Commercialization of the Product in accordance with this Agreement and any
Supplemental Development Plan, and otherwise to exercise Dyax’s rights and
perform Dyax’s obligations under this Agreement and/or the Supply Agreements,
as applicable.

 

Section 3.4             Fovea Retained Rights.  Any rights of Fovea not expressly granted to
Dyax, or otherwise expressly restricted or limited, under the provisions of
this Agreement shall be retained by Fovea.  
Without limiting the generality of the immediately preceding sentence,
Fovea shall retain the right, subject to the provisions of Article IX and Section
10.1 hereof, to (a) exploit and license Fovea Intellectual Property and Fovea
Product Intellectual Property for purposes unrelated to products containing the
Compound, without any duty to account to Dyax or obtain Dyax’s consent for such
exploitation or license, and (b) participate in the Development, Manufacture
and Commercialization of the Product in accordance with this Agreement and the
Core Development Plan, and otherwise to exercise Fovea’s rights and perform
Fovea’s obligations under this Agreement and/or the Supply Agreements, as
applicable.

 

ARTICLE IV

DEVELOPMENT

 

Section 4.1            Current Status; Certain Product
Requirements.

 

(a)           Prior to the Effective Date, Dyax has independently
completed one and initiated a second Phase III Clinical Study of the Compound
for the treatment of hereditary angioedema, as well as 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

18

 

a Phase I/II Clinical Study of the Compound in patients undergoing
on-pump cardiothoracic surgery.  As of
the Effective Date, no clinical studies of the Compound in the Field have been
initiated.

 

(b)           The Product formulation Commercialized by Fovea or
its Related Parties under this Agreement shall be different from (i) the
formulations of the Compound that have been developed prior to the Effective
Date and (ii) any and all formulations of the Compound (or any product
containing the Compound) that are Developed and/or Commercialized by Dyax and
its Related Parties for use outside the Field.

 

Section 4.2            Development Plans;
Amendments; Development Responsibilities.

 

(a)           The Development of the
Product in the Field shall be governed by the “Core Development Plan”
and the “Supplemental Development Plan.” The Core Development Plan, a
copy of which shall be attached hereto as Exhibit B within sixty (60)
days after the Effective Date, shall initially set forth a plan for Developing
the Product for [*****], as
well as strategies and timelines for completing such activities.

 

(i)            The Core Development Plan
shall be updated and modified from time to time to cover all the Development
activities reasonably necessary in order to develop a formulation and packaging
of the Product meeting the requirements of Section 4.1(b).  [*****]
Thereafter, the Core Development Plan shall also be updated and modified from
time to time to reflect all Development activities planned by Fovea to obtain
Regulatory Approval of such Product in the Field in the Fovea Territory, as
well as to include any changes or modifications planned by Fovea to such
Development activities and any changes or modifications that Fovea is required
to implement pursuant to the provisions set forth below in this Section 4.2(a)(i).

 

Subject to the provisions of clauses (x) and (y) set forth below in
this Section 4.2(a)(i), Fovea shall be obligated, based on applicable input
from EMEA and FDA and Dyax, to update the design of the Development activities
covered by the Core Development Plan so that, to the extent reasonably feasible
from a regulatory and scientific perspective, the data generated in connection
with such Development activities shall be sufficient to support Regulatory
Approval in the United States of the Product [*****]. Notwithstanding anything expressed or implied in this
Agreement to the contrary, (x) the Development activities of Fovea pursuant to
this Agreement as set forth in the Core Development Plan shall be only with
respect to the Product in the form (including, without limitation, the
formulation) being Developed by Fovea for the purpose of applying for
Regulatory Approval in the Fovea Territory and, in the event that the United
States or any other country in the Dyax Territory requires a form of the
Product (including, without limitation, the formulation thereof) that is
different in any way from the form of the Product being developed by Fovea
hereunder for the purpose of applying for Regulatory Approval in the Fovea
Territory, Fovea shall have no obligation to make any change in the form of
such Product being developed by Fovea or to perform any Development activities
of any kind with any form of the Product that is different in any way from the
form of such Product being developed by Fovea, and (y) Fovea shall have no obligation
to conduct any Post-Approval Study required or requested by Dyax or by any
Regulatory Authority in any country of the Dyax Territory or to change, modify
or otherwise conduct any Post-Approval Study required or requested by any
Regulatory Authority in any country of the Fovea Territory or that Fovea is
otherwise conducting or planning to conduct for purposes of generating data 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

19

 

from such Post-Approval Study by Fovea that would satisfy the
requirements or needs of Dyax or any Regulatory Authority in the Dyax
Territory.

 

(ii)           The Supplemental Development
Plan shall cover all the Development activities, including, without limitation,
any new or additional Clinical Studies or any new or additional cohort of
subjects or “arms” to be added to any Clinical Study, that Dyax plans to pursue
at its sole discretion and that are conducted in connection with the Regulatory
Approval of the Product in the Field in the United States and the other
countries within the Dyax Territory.  For
clarity, nothing in this Section 4.2(a)(ii) shall limit any of Fovea’s
obligations under this Section 4.2(a) and nothing in this Agreement shall obligate
Dyax to conduct any such Development activities.

 

(b)           Fovea shall be responsible for the Development
activities set forth in the Core Development Plan.  The JSC shall review and monitor the clinical
and regulatory program for the Product under the Core Development Plan.  Fovea shall review the Core Development Plan
not less frequently than annually and shall develop detailed and specific Core
Development Plan updates, which shall include annual budgets, for each calendar
year until the completion of the Product Development activities covered by the
Core Development Plan.  Fovea shall
submit all such updates to the JSC for review and approval no later than [*****] and, upon the JSC’s approval,
such updates shall be appended to the Core Development Plan. Each Party may
also develop and submit to the JSC from time to time other proposed substantive
amendments to the Core Development Plan. 
The JSC shall review proposed amendments to the Core Development Plan
presented by a Party at the next scheduled meeting of the JSC, or earlier if
the JSC so agrees, and may approve such proposed amendments and/or any other
proposed amendments that the JSC may consider from time to time in its
discretion and, upon such approval by the JSC, the Core Development Plan shall be
amended accordingly.

 

(c)           Dyax shall be responsible for the Development
activities set forth in any Supplemental Development Plan proposed by
Dyax.  The JSC shall review, discuss and
comment on the clinical and regulatory programs for the Product under any
Supplemental Development Plan but shall have no authority to approve or
disapprove of the Supplemental Development Plan or the Development activities
of Dyax under the Supplemental Development Plan and Dyax shall have no
obligation to make any changes to the Supplemental Development Plan in response
to any comments from the JSC. Dyax shall review any Supplemental Development
Plan not less frequently than annually and shall develop Supplemental
Development Plan updates for each calendar year until the completion of the
Product Development activities covered by any such Supplemental Development
Plan.

 

(d)           Neither Fovea nor its Related Parties shall,
directly or through any Third Party, initiate, sponsor, fund, supply Product
for, or otherwise conduct any Clinical Study of the Product not described in
the then-effective Core Development Plan without the prior written approval of
Dyax.

 

Section 4.3            Development Efforts; Manner
of Performance; Reports.

 

(a)           Fovea shall use Diligent
Efforts to execute and to perform, or cause to be performed, the activities for
which it is responsible under the Core Development Plan and to cooperate with
Dyax in carrying out the Core Development Plan, in good scientific manner and
in compliance with all applicable laws and regulations and good clinical and
laboratory practice.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

20

 

(b)           Fovea will keep Dyax fully
informed as to its progress, results (including the development of any
technology or inventions), status and plans for performing and implementing the
Core Development Plan.  In addition,
within [*****], Fovea will
provide to the JSC a written progress report, which will describe the Development
activities that Fovea has performed or caused to be performed during [*****], evaluate the work performed
in relation to the goals of the Core Development Plan, and provide such other
information as may be required by the Core Development Plan or reasonably
requested by the JSC with respect to such Development activities.

 

(c)   Dyax will keep Fovea
reasonably informed as to its progress, results (including the development of
any technology or inventions), status and plans for performing and implementing
any Supplemental Development Plan.

 

Section 4.4            Regulatory Submissions and
Regulatory Approvals.

 

(a)           Fovea shall own all regulatory submissions,
including all applications, for Regulatory Approvals of the Product in the
Field in the Fovea Territory, and shall be responsible for seeking and
obtaining all Regulatory Approvals of the Product in the Field in the Fovea
Territory as provided in the Core Development Plan.  Dyax shall own all regulatory submissions,
including all applications, for Regulatory Approvals of the Product in the Dyax
Territory and shall, at Dyax’s sole discretion, be solely responsible for
seeking and obtaining all Regulatory Approvals for the Product in the Dyax
Territory.  Each Party shall have access
to all data contained or referenced in such submissions or applications for
Regulatory Approvals of the Product, including without limitation all reports,
correspondence and conversation logs, in each case as may be reasonably
necessary to enable (i) Fovea to exercise its rights, and fulfill its
obligations, under this Agreement to Develop, Manufacture and Commercialize the
Product in the Field in the Fovea Territory and to perform its obligations
under the Core Development Plan, and (ii) Dyax to Develop, Manufacture and
Commercialize the Product outside the Fovea Territory and to exercise its
retained rights with respect to all products containing the Compound.  Each Party shall provide appropriate
notification of such right of the other Party to the Regulatory Authorities.

 

(b)           In the event that Fovea fails to use Diligent
Efforts to seek any Regulatory Approval of the Product in any country of the
Fovea Territory as provided in the Core Development Plan, Dyax shall have the
right to seek such Regulatory Approval, in Dyax’s or Fovea’s name, upon [*****] prior notice to Fovea and in
such case Fovea shall cooperate with Dyax’s efforts to obtain such Regulatory
Approval in any such country and, if necessary, shall designate Dyax as its
agent for such purpose; provided
that, if Fovea provides Dyax with assurances reasonably satisfactory to Dyax of
Fovea’s plan for immediately resuming Diligent Efforts to obtain such
Regulatory Approval of the Product within such [*****] period, then Dyax shall not undertake such efforts to
obtain such Regulatory Approval for so long as Fovea continues to use Diligent
Efforts to obtain such Regulatory Approval.

 

(c)           Dyax will have the right to participate in all
material meetings and other contact with Regulatory Authorities pertaining to
Development or Regulatory Approval of the Product in the Fovea Territory.  To the extent reasonably possible and
practicable, Fovea shall provide Dyax with reasonable advance notice of all
such meetings and other contact and advance copies of all related documents and
other relevant information relating to such meetings or other contact.  Fovea will have the 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

21

 

right to participate in all material meetings and other contact with
Regulatory Authorities pertaining to Development or Regulatory Approval of the
Product in the Field in the Dyax Territory but only if and to the extent such
participation would be reasonably useful to the development of the Product in
the Field in the Fovea Territory.  To the
extent reasonably possible and practicable, Dyax shall provide Fovea with
reasonable advance notice of all such meetings and other contact and advance
copies of all related documents and other relevant information relating to such
meetings or other contact.

 

(d)           Each Party shall provide the other Party with drafts
(in English) of any material documents or other material correspondence
pertaining to Regulatory Approvals of the Product in the Field in such Party’s
Territory to be submitted by such Party to Regulatory Authorities, including
without limitation any proposed labeling, sufficiently in advance of submission
so that the other Party may review and comment on such documents and other
correspondence and have a reasonable opportunity to influence the substance of
such submissions in a manner consistent with the goal of obtaining Regulatory
Approvals of the Product in the Field in the Territory of the submitting Party
as quickly as reasonably practicable.  The non-submitting Party’s approval of such
submissions shall not be unreasonably withheld or delayed.  Each Party shall promptly provide to the
other Party copies (in English) of any material documents or other material
correspondence pertaining to the Product in the Field, including without
limitation all proposed labeling, received from Regulatory Authorities in the
Territory of the submitting Party.  Each
Party shall promptly provide the other Party with copies of all other material
documents and correspondence pertaining to the Product in the Field after they
have been submitted to, or received from, Regulatory Authorities in the
Territory of the submitting Party.

 

(e)           Each Party shall have the right to make regulatory
submissions and applications (including, without limitation, the filing of an
IND) in the Territory of the other Party if and to the extent that such
regulatory submissions and applications are required for purposes of such Party
performing or carrying out its Development activities pursuant to, and in
accordance with, the provisions of this Agreement.  Unless otherwise agreed by the Parties, each
Party shall own all INDs filed by it for purposes of performing its Development
responsibilities with respect to the Product as permitted under this
Agreement.  Each Party shall have the
right to cross-reference and make any other use of the other Party’s INDs for
the Product that it would have if it were the owner, including without
limitation access to all data contained or referenced in such INDs, in each
case as may be reasonably necessary to enable such Party to Develop,
Manufacture or Commercialize the Product in and for its Territory in accordance
with the terms of this Agreement.

 

(f)            Fovea and its Affiliates shall take the lead in all
pricing and reimbursement approval proceedings relating to the Product in the
Fovea Territory.  Dyax and its Affiliates
shall control all pricing and reimbursement approval proceedings relating to
the Product in the Dyax Territory.  To
the extent consistent with applicable law, Dyax shall have the right to attend
all meetings between Fovea and Regulatory Authorities relating to pricing and
reimbursement approvals relating to the Product in the Fovea Territory.  To the extent consistent with applicable law,
Fovea shall provide Dyax with reasonable advance notice of all such meetings
and advance copies of all related documents and other relevant information
relating to such meetings or proceedings. 
At a reasonable time prior to any meeting between a Party and Regulatory
Authorities relating to the pricing and reimbursement approvals for the Product
in such Party’s Territory, to the extent consistent with applicable law, such
Party shall solicit the other Party’s input and feedback on the substantive
issues to be discussed by such Party with the applicable 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

22

 

Regulatory Authorities at such meeting with respect to pricing and
reimbursement approvals in the Territory of such Party.  To the extent consistent with applicable law,
each Party shall provide the other Party with drafts of all submissions
relating to pricing and reimbursement approvals relating to the Product in the
Territory of such Party (in English) for the other Party’s review and comment
prior to their submission.  Furthermore,
to the extent consistent with applicable law, Fovea shall provide Dyax with
copies (in English) of any material documents or other material correspondence
pertaining to pricing and reimbursement approvals relating to the Product in
the Major European Countries, and upon request, the remaining countries of the
Fovea Territory, and Dyax shall, to the extent consistent with applicable law,
provide Fovea with copies (in English) of any material documents or other
material correspondence pertaining to pricing and reimbursement approvals
relating to the Product in the United States.

 

(g)           At each meeting of the JSC, each Party shall make a
presentation regarding (i) such Party’s strategy relating to seeking and
obtaining Regulatory Approval of the Product, and (ii) such Party’s progress in
seeking and obtaining Regulatory Approval of the Product in such Party’s
Territory.  At each meeting of the JSC,
each Party shall also provide to the JSC an update of such Party’s past and
future planned interactions with Regulatory Authorities with respect to matters
relevant to Regulatory Approval of the Product in such Party’s Territory.  At each meeting of the JSC, the JSC shall
discuss each Party’s strategy and progress in seeking and obtaining Regulatory
Approval of the Product in such Party’s Territory, as well as such Party’s past
and future planned interactions with Regulatory Authorities, and the JSC shall
have the opportunity to comment on and provide substantive feedback to each
Party on such matters.

 

Section 4.5             Complaints; Adverse Event
Reporting Procedures; Notice of Adverse Events Affecting the Product.  Each Party will maintain a record of any and
all complaints it receives with respect to the Product.  Each Party will notify the other Party in
reasonable detail of any complaint received by the Party with respect to the
Product within sufficient time to allow the other Party and its Related Parties
to comply with any and all regulatory and other requirements imposed upon them
in any jurisdiction in which the Product is being marketed or tested in
Clinical Studies.  Each Party will (a) provide
the other Party with all adverse event information and safety data relating to
the Product in its control necessary or desirable for the other Party to comply
with all applicable laws, rules and regulations with respect to the Product and
(b) report and provide such information to the other Party in such a manner and
time so as to enable the other Party to comply with all applicable laws, rules and
regulations.  Dyax shall maintain a
global adverse event database for the Compound and shall generate adverse event
reports for Fovea’s use in the Fovea Territory. 
Fovea shall have access to all data in the global adverse event
database. Fovea shall have access to all data in the global adverse event
database. Fovea shall reimburse Dyax for [*****]
of Dyax’s internal and external costs and expenses of maintaining the
global adverse event database, within thirty (30) days of receipt of an invoice
from Dyax, which invoices shall be provided on an annual basis.  Each Party shall be responsible for
submitting adverse event reports with respect to the Product to the applicable
Regulatory Authorities in its own Territory. In addition, each Party shall
promptly notify the other if such Party becomes aware of any information or
circumstance that are likely to have a material adverse effect on the
Development, Manufacture or Commercialization of the Product in the other Party’s
Territory. Within six (6) months after the Effective Date the Parties will
develop and agree in writing upon safety data exchange procedures governing the
coordination of collection, investigation, reporting, and exchange of
information concerning any adverse experiences, and

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

23

 

 

any product quality and product complaints
involving adverse experiences, related to the Product, sufficient to enable
each Party to comply with its legal and regulatory obligations.

 

Section 4.6            Development Costs.  Fovea shall bear 100% of the Development
Costs incurred in the performance of the Core Development Plan.  Dyax shall bear 100% of the Development Costs
incurred in the performance of the Supplemental Development Plan.

 

Section 4.7            Diligent Efforts; Compliance.

 

(a)           Fovea shall use Diligent Efforts to perform its
Development activities under the Core Development Plan in accordance with this
Agreement.

 

(b)           Fovea’s Diligent Efforts shall include the following
minimum requirements:

 

(i)            at least one of the following shall occur in each
calendar year during the Term and Fovea’s failure to achieve these requirements
shall be deemed a material breach of this Agreement [*****]; and

 

(ii) subject to provisions of Section 4.7(c),
Fovea’s Diligent Efforts shall include the achievement of the following Development
milestones, and Fovea’s failure to achieve these milestones shall be deemed a
material breach of this Agreement : [*****].

 

(c)           Notwithstanding the foregoing, Fovea may extend the
period for completion of any Development milestone described in Section 4.7(b)(ii)
above by up to [*****].

 

(d)           Each Party shall conduct the Development,
Manufacture and Commercialization of the Product in accordance with all
applicable laws, rules and regulations, including without limitation, current
governmental regulations concerning good laboratory practices, good clinical
practices and good manufacturing practices.

 

ARTICLE V

COMMERCIALIZATION

 

Section 5.1            [*****].  Fovea shall [*****] Commercialize the Product in the Field in the Fovea
Territory and shall bear all costs and expenses of Commercializing the Product
in the Field in the Fovea Territory.

 

Section 5.2            Commercialization Plans.  Upon filing by Fovea for Regulatory Approval
for the Product in the Fovea Territory, Fovea shall develop an annual
Commercialization plan (including a budget) for the Product in the Fovea
Territory.  Such Commercialization plan
shall include, without limitation, a strategy for obtaining Product pricing and
reimbursement approvals in the Fovea Territory. 
Fovea shall submit its Commercialization plan to the JSC for review,
discussion and commentary.  The
Commercialization plan of Fovea, and particularly the plans and budgets for the
Major European Countries, shall contain sufficient detail with respect to
Commercialization tactics and other matters to enable the JSC to conduct a
meaningful review of such plan.  Upon
filing by Dyax for Regulatory 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

24

 

Approval for the Product in the Dyax
Territory, Dyax shall submit a Commercialization plan for the Dyax Territory to
the JSC for review and discussion.  Such
Commercialization plan shall include, without limitation, a strategy for
obtaining Product pricing and reimbursement approvals in the Dyax Territory.  The
JSC shall review, discuss and comment on the Commercialization plan of each
Party and on each Party’s Commercialization program and activities for the
Product under such Party’s Commercialization plan but the JSC shall have no
authority to approve or disapprove of either Party’s Commercialization plan or
the Commercialization program and activities of either Party under such Party’s
Commercialization plan and neither Party shall have any obligation to make any
changes to its Commercialization plan or to its Commercialization program or
activities in response to any comments from the JSC.  Notwithstanding any other provision of this
Agreement, Fovea shall be solely responsible for all decisions regarding the
prices charged for the Product in the Fovea Territory, and Dyax shall be solely
responsible for all decisions regarding the prices charged for the Product in
the Dyax Territory.

 

Section 5.3             Advertising and Promotional
Materials.  Fovea shall
be responsible for the creation, preparation, production, reproduction and
filing with the applicable Regulatory Authorities, of relevant written sales,
promotion and advertising materials relating to the Product (“Promotional
Materials”) for use in the Fovea Territory. 
All such Promotional Materials shall be compliant with all applicable
laws, rules and regulations, and any guidelines established by the
pharmaceutical industry in the applicable country, and consistent with the
Commercialization plan for the Fovea Territory. 
[*****] Dyax shall be
responsible for the creation, preparation, production, reproduction and filing
with the applicable Regulatory Authorities of Promotional Materials for use in
the Dyax Territory.  All such Promotional
Materials of Dyax shall be compliant with all applicable laws, rules and
regulations, and any guidelines established by the pharmaceutical industry in
the applicable country, and consistent with the Commercialization plan for the
Dyax Territory.  [*****] Neither Party shall make any medical or promotional
claims for the Product other than as permitted by applicable laws, rules and
regulations.  When distributing
information related to the Product or its use (including information contained
in scientific articles, reference publications and publicly available
healthcare economic information), each Party shall comply with all applicable
laws, rules and regulations and any guidelines established by the
pharmaceutical industry in the applicable country in the Territory of such
Party.

 

Section 5.4             Sales and Distribution.  Each Party and its Related Parties shall be
responsible for booking sales and shall warehouse and distribute the Product in
its own Territory.  If a Party receives
any orders for the Product in the other Party’s Territory, it shall refer such
orders to the other Party.  Moreover,
each Party and its Related Parties shall be solely responsible handling all
returns of the Product, as well as all aspects of Product order processing, invoicing
and collection, distribution, inventory and receivables, in it own Territory.

 

Section 5.5             Recalls, Market Withdrawals
or Corrective Actions.   In
the event that any Regulatory Authority issues or requests a recall or takes a
similar action in connection with the Product in a Territory, or in the event
either Party determines that an event, incident or circumstance has occurred
that may result in the need for a recall or market withdrawal in its own
Territory, the Party notified of such recall or similar action, or the Party
that desires such recall or similar action, shall within twenty-four (24) hours
advise the other Party thereof by telephone or facsimile.  Each Party, in consultation with the other
Party, shall decide whether to conduct a recall in its own Territory and the
manner in which any such recall shall be conducted (except in the case of a
government mandated recall, when such Party may 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

25

 

act without such advance notice but shall
notify the other Party as soon as possible). 
Each Party shall bear the expense of any such recall in its own
Territory, provided that this will not limit any remedy that such Party
may otherwise have against the other Party in connection with such recall.  Each Party will make available all of its
pertinent records that may be reasonably requested in order to effect a recall
in the other Party’s Territory.

 

ARTICLE VI

MANUFACTURE AND SUPPLY

 

Section 6.1            Supply by Dyax.

 

(a)           Development Stage.  At the written request of Fovea, which
request may be made at any time and from time to time after the Effective Date
and shall in any event be made by Fovea with sufficient advance notice to be
commercially reasonable (or with such other period of advance notice as the
Parties may otherwise agree), Dyax shall use Diligent Efforts to Manufacture
and supply API Bulk Drug Substance to Fovea in sufficient quantities to satisfy
the reasonable requirements of Fovea and its Related Parties (i) for use
thereof in Development activities of the Product conducted in accordance with
the Core Development Plan and (ii) for use in the Manufacture of Finished
Product by Fovea pursuant to Section 6.2(a) below.  Dyax shall not be deemed or treated as being
in breach of any of its obligations under this Section 6.1(a) to use Diligent
Efforts to supply API Bulk Drug Substance to Fovea in the case of [*****].

 

(b)           Commercialization Stage.  At the written request of Fovea, which
request shall be made at least [*****]
prior to the reasonably expected date of First Commercial Sale of the
Product in the Fovea Territory, Dyax shall use Diligent Efforts to Manufacture
and supply API Bulk Drug Substance to Fovea in sufficient quantities to meet
all of the requirements of Fovea and its Related Parties for use thereof in the
Manufacture of Finished Product for (i) commercial sale in the Fovea Territory
and (ii) supply to Dyax for commercial sale in the Dyax Territory, provided
that the foregoing obligation of Dyax to use Diligent Efforts shall be subject
to the provisions of Exhibit E hereto. 
Any request as provided above that requires production of another batch
of API Bulk Drug Substance shall in any event be made by Fovea with at least [*****] advance notice (or such other
period of advance notice as may be set forth in the Dyax Supply Agreement or as
the Parties may otherwise agree).

 

(c)           Price.  Fovea shall pay Dyax, or cause Dyax to be
paid, the applicable Transfer Price for any such API Bulk Drug Substance ordered
by Fovea.

 

(d)           Termination of Supply.  The obligations of Dyax under this Section 6.1
may be terminated by Dyax by giving written notice to Fovea that Dyax is
terminating its supply obligations under this Section 6.1, in which case such
obligations of Dyax shall terminate on the earlier of (i) the date on which
Fovea and/or its Related Parties have established an alternative source of
supply of API Bulk Drug Substance that can replace, without material
interruption or delay, Dyax’ supply of API Bulk Drug Substance pursuant to this
Section 6.1 and (ii) the [*****] that
Dyax gives written notice of termination to Fovea pursuant to the foregoing
provisions of this Section 6.1(d); provided, however, that,
notwithstanding the foregoing, in no event shall Dyax’ obligations under this Section
6.1 terminate unless 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

26

 

and until Dyax and all of its Related Parties and the Other Related
Dyax Licensees have discontinued all Manufacturing of API Bulk Drug
Substance.   In the event that, at any
time during the period in which Dyax has an obligation to supply API Bulk Drug
Substance pursuant to this Section 6.1, Dyax is unable to supply sufficient
quantities of API Bulk Drug Substance to meet the reasonable requirements of
Fovea and its Related Parties for use thereof in connection with the purposes
and activities set forth in Section 6.1(a) or (b) as indicated in any good
faith forecasts to be provided pursuant to the Dyax Supply Agreement or this Section
6.1, then Fovea shall have the right (but not the obligation) to Manufacture
API Bulk Drug Substance solely for such purposes and activities.  Fovea may exercise its rights under this Section
6.1(d) with respect to API Bulk Drug Substance by giving thirty (30) days prior
written notice to Dyax.  Fovea may also
exercise its rights under this Section 6.1(d) upon the effective date of any
termination by Dyax of its supply obligations as provided above.  The exercise by Fovea of any of its rights
under this Section 6.1(d) shall not relieve Dyax of its supply obligations
under this Section 6.1.  Upon receipt by
Dyax of written notice from Fovea to the effect that Fovea is exercising its
rights under this Section 6.1(d), Dyax shall provide reasonable assistance, at
Fovea’s expense, to enable Fovea to Manufacture or have Manufactured and
supplied API Bulk Drug Substance.  [*****]

 

(e)           Limitations on Use.  Any API Bulk Drug Substance Manufactured by
or on behalf of Fovea pursuant to Section 6.1(d) may be used solely in
Development activities of the Product conducted in accordance with the Core
Development Plan, in Commercialization activities for the Product conducted in
accordance with the terms of this Agreement, or in the Manufacture and supply
of Finished Product by Fovea pursuant to Section 6.2 below.  Upon exercise by Fovea of its rights under Section
6.1(d) with respect to API Bulk Drug Substance, Fovea may elect to satisfy some
or all of the future requirements that it and its Related Parties may have with
respect to API Bulk Drug Substance through its own Manufacturing efforts
pursuant to Section 6.1(d) hereof.

 

Section 6.2            Supply by Fovea.

 

(a)           Development Stage.  From and after the time when the Development
activities of the Parties under the Core Development Plan or any Supplemental
Development Plan require the availability of Finished Product, Fovea shall use
Diligent Efforts (x) to Manufacture Finished Product in sufficient quantities to
meet the requirements of Fovea and its Related Parties for use thereof in
Development activities of the Product conducted in accordance with the Core
Development Plan and (y) to Manufacture and supply to Dyax Finished Product in
sufficient quantities to meet the reasonable requirements of Dyax and its
Related Parties for use thereof in Development activities of the Product
conducted pursuant to any Supplemental Development Plan, provided that
Dyax shall have made a written request for such quantities of Finished Product
with sufficient advance notice to be commercially reasonable (or with such
other period of advance notice as the Parties may otherwise agree).  Dyax shall provide Fovea with good faith
written forecasts of such reasonable requirements at such time or times as
Fovea may reasonably request or as required pursuant to the Fovea Supply
Agreement.

 

(b)           Commercialization Stage.  As soon as practicable after Fovea requests
that Dyax supply Fovea with API Bulk Drug Substance pursuant to Section 6.1(b) hereof,
Fovea shall use Diligent Efforts (x) to Manufacture Finished Product in
sufficient quantities to meet all of the requirements of Fovea and its Related
Parties for commercial sale thereof in the Fovea Territory and (y) to
Manufacture and supply Finished Product to Dyax in sufficient quantities to
meet all of the requirements of Dyax and 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

27

 

its Related Parties for commercial sale thereof in the Dyax Territory, provided
that Dyax shall have made a written request for such quantities of Finished
Product with sufficient advance notice to be commercially reasonable (or with
such other period of advance notice as the Parties may otherwise agree).  Dyax shall provide Fovea with good faith
written forecasts of such reasonable requirements at such time or times as
Fovea may reasonably request or as required pursuant to the Fovea Supply Agreement.

 

(c)           Price.  Dyax shall pay Fovea, or cause Fovea to be
paid, the applicable Transfer Price for any Finished Product ordered by Dyax.

 

(d)           Conditions.  Notwithstanding anything express or implied
in the foregoing provisions of this Section 6.2 or elsewhere in this Agreement
to the contrary, (A) the Finished Product that Fovea is required to Manufacture
and supply to Dyax pursuant to this Section 6.2 shall be the same as the
Finished Product Manufactured by Fovea to meet the requirements of Fovea and/or
its Related Parties for Finished Product at the relevant stage of Development
or Commercialization, (B) Fovea’s obligations to Manufacture and supply units
of Finished Product pursuant to this Section 6.2 is subject to the condition
precedent that, if Dyax is supplying API Bulk Drug Substance to Fovea, Dyax
shall have filled all orders for API Bulk Drug Substance placed under the Dyax
Supply Agreement or Section 6.1 hereof to allow Manufacture and supply of such
units of Finished Product (after giving effect to the provisions set forth above
in Section 6.1(a) and Exhibit E, as relevant, with respect to shortages of API
Bulk Drug Substance), and (C) Fovea shall not be deemed or treated as being in
breach of any of its obligations under this Section 6.2 to use Diligent Efforts
to Manufacture and/or supply Finished Product in the case of any failure or
inability of Fovea to Manufacture and/or supply or cause to be Manufactured
and/or supplied Finished Product pursuant to this Section 6.2 if (i) such
failure or inability is due to a shortage of Finished Product and the available
supply of Finished Product, if any, is allocated by Fovea between the Parties
on a pro-rata basis based on good faith forecasts of the respective
requirements of the Parties and their Related Parties, which, in the case of
the requirements of Dyax and its Related Parties, shall have been provided by
Dyax to Fovea in writing [*****] and
(ii) Fovea uses Diligent Efforts to resolve all failure to Manufacture and/or
supply issues as promptly as possible in consultation with Dyax.

 

(e)           Termination of Supply.  The obligations of Fovea under this Section 6.2
to supply Finished Product to Dyax may be terminated by Fovea by giving written
notice to Dyax that Fovea is terminating such obligations under this Section 6.2,
in which case such obligations of Fovea shall terminate on the earlier of (i) the
date on which Dyax and/or its Related Parties have established an alternative
source of supply of Finished Product that can replace, without material
interruption or delay, Fovea’s supply of Finished Product pursuant to this Section
6.2 and (ii) the [*****] that
Fovea gives written notice of termination to Dyax pursuant to the foregoing
provisions of this Section 6.2(e); provided, however, that,
notwithstanding the foregoing, in no event shall Fovea’s obligations under Section
6.2(a) or (b) to supply Finished Product to Dyax terminate unless and until
Fovea and all of its Related Parties have discontinued all Manufacturing of
Finished Product. In the event that, at any time during the period in which
Fovea has an obligation to supply Finished Product to Dyax pursuant to Section 6.2(a)
or (b) above, Fovea is unable to supply or have supplied sufficient quantities
of Finished Product to meet the reasonable requirements of Dyax and its Related
Parties for use thereof in connection with the purposes and activities set
forth in Section 6.2(a) or (b), as applicable, as indicated in good faith
forecasts to be provided by Dyax pursuant to the Fovea Supply Agreement or this
Section 6.2, then Dyax 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

28

 

shall have the right (but not the obligation) to Manufacture Finished
Product solely for such purposes and activities.  Dyax may exercise its rights under this Section
6.2(e) with respect to Finished Product by giving thirty (30) days prior
written notice to Fovea.  Dyax may also
exercise its rights under this Section 6.2(e) upon the effective date of any
termination by Fovea of its supply obligations as provided above.  The exercise by Dyax of any of its rights
under this Section 6.2(e) shall not relieve Fovea of its supply obligations
under this Section 6.2.  Upon receipt by
Fovea of written notice from Dyax to the effect that Dyax is exercising its
rights under this Section 6.2(e), Fovea shall provide reasonable assistance, at
Dyax’s expense, to enable Dyax to Manufacture or have Manufactured Finished
Product.  [*****]

 

(f)            Limitations on Use.  Any Finished Product Manufactured by or on
behalf of Dyax pursuant to Section 6.2(e) may be used solely in
Commercialization of the Product by Dyax and its Related Parties in accordance
with this Agreement.  Upon exercise by
Dyax of its rights under Section 6.2(e) with respect to Finished Product, Dyax
may elect to satisfy some or all of the future requirements that it and its
Related Parties may have with respect to Finished Product through its own
Manufacturing efforts pursuant to Section 6.2(e) hereof.

 

Section 6.3            Subcontractors.

 

(a)           Fovea may grant to one or
more of its Related Parties or contract manufacturers any right that Fovea may
have under Section 6.1 to Manufacture API Bulk Drug Substance, and may delegate
to one or more of its Related Parties or contract manufacturers any obligation
that Fovea may have under Section 6.2 to Manufacture and supply Finished
Product, and, in either case, each of the Related Parties or contract
manufacturers to whom such right has been granted or such obligation has been
delegated, as the case may be, may exercise such right and/or shall perform
such obligation, as the case may be, subject to and upon the same terms and
conditions as would be applicable to Fovea under Section 6.1 or Section 6.2, as
relevant, if Fovea were exercising such right and/or performing such
obligation, as the case may be.

 

(b)           Dyax may grant to one or
more of its Related Parties or contract manufacturers any right that Dyax may
have under Section 6.2 to Manufacture Finished Product, and may delegate to one
or more of its Related Parties, Other Related Dyax Licensees or contract
manufacturers any obligation that Dyax may have under Section 6.1 to
Manufacture and supply API Bulk Drug Substance, and, in either case, each of
the Related Parties, Other Related Dyax Licensees or contract manufacturers to
whom such right has been granted or such obligation has been delegated, as the
case may be, may exercise such right and/or shall perform such obligation, as
the case may be, subject to and upon the same terms and conditions as would be
applicable to Dyax under Section 6.1 or Section 6.2, as relevant, if Dyax were
exercising such right and/or performing such obligation, as the case may be.

 

(c)           Any delegation by either
Party to any Related Party or contract manufacturer of such Party, or by Dyax
to any Other Related Dyax Licensee, of any obligation that such Party may have
under Section 6.1 or Section 6.2 to Manufacture and supply API Bulk Drug
Substance or Finished Product, as the case may be, shall not release such Party
from such obligation and such Party shall be responsible for the performance by
such Related Party, contract manufacturer or Other Related Dyax Licensee, as
the case may be, of such obligation and shall remain liable to the other Party
if such 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

29

 

obligation is not performed by such Related
Party,contract manufacturer or Other Related Dyax Licensee, as the case may be,
on a timely basis in accordance with Section 6.1 or Section 6.2, as relevant.

 

Section 6.4            Supply Agreements.

 

(a)           [*****] the Parties
shall negotiate in good faith and enter into a supply agreement pursuant to
which Dyax will supply to Fovea API Bulk Drug Substance (the “Dyax  Supply
Agreement”). The Dyax Supply Agreement shall include the applicable terms
set forth in Section 6.1, 6.3 and Exhibit E of this Agreement and shall
contain such other provisions that the Parties mutually agree upon that are
customary for supply agreements of this type. 
Pending the execution and delivery of the Dyax Supply Agreement, Dyax
shall perform its obligations under Section 6.1 in accordance with its
terms.   Upon written request of Dyax
made after execution of the Dyax Supply Agreement, the Parties shall negotiate
in good faith and enter into a supply agreement pursuant to which Fovea will
supply Finished Product to Dyax (the “Fovea  Supply Agreement”;
each of the Fovea Supply Agreement and the Dyax Supply Agreement is a “Supply
Agreement” and collectively are referred to as the “Supply Agreements”).  The Fovea Supply Agreement shall include the
applicable terms set forth in Section 6.2 and Section 6.3 hereof, shall, to the
extent possible (unless the Parties otherwise agree), impose rights and
obligations on Fovea that are consistent with the rights and obligations of
Dyax under the Dyax Supply Agreement and the applicable provisions of Section 6.1
and shall contain such other provisions that the Parties mutually agree upon
that are customary for supply agreements of this type.  Pending the execution and delivery of the
Fovea Supply Agreement, Fovea shall perform its obligations under Section 6.2
in accordance with its terms.

 

(b)           Each Party will appoint at least one manufacturing
logistics and quality assurance manager to support the Parties’ respective
Product Manufacturing activities, and to function as a liaison with the other
Party on matters relating to the Manufacture and supply of API Bulk Drug
Substance and Finished Product.

 

ARTICLE VII

FINANCIAL PROVISIONS

 

Section 7.1            Royalties.

 

(a)           Royalty Rates.  Subject to Sections 7.1(b), (c) and (d), (i) Fovea
shall pay to Dyax royalties on aggregate Net Sales in the Fovea Territory as
follows:

 

	
  Calendar
  Year Net Sales of the Product

  	
   

  	
  Royalties (as a percentage of such Net Sales)

  	
   

  
	
  $[*****] -
  $[*****]

  	
   

  	
  [*****]

  	
  %

  
	
  $[*****] -
  $[*****]

  	
   

  	
  [*****]

  	
  %

  
	
  Greater than $[*****]

  	
   

  	
  [*****]

  	
  %

  

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

30

 

;
and (ii) Dyax shall pay to Fovea royalties on aggregate Net Sales in the Dyax
Territory as follows:

 

	
  Calendar
  Year Net Sales of the Product

  	
   

  	
  Royalties (as a percentage of such Net Sales)

  	
   

  
	
  $[*****] -
  $[*****]

  	
   

  	
  [*****]

  	
  %

  
	
  $[*****] -
  $[*****]

  	
   

  	
  [*****]

  	
  %

  
	
  Greater than $[*****]

  	
   

  	
  [*****]

  	
  %

  

 

(b)           Applicability of Royalty Rates to Net Sales.  Royalties on aggregate Net Sales of the
Product inside and outside the Fovea Territory in a calendar year shall be paid
at the rate applicable to the portion of Net Sales within each of the Net Sales
levels above during such calendar year. 
For example, if during a calendar year, Net Sales of the Product in the
Fovea Territory were equal to $[*****],
the royalties payable by Fovea would be calculated by adding (i) the royalties
with respect to the first $[*****] at
the first level percentage of [*****] ($[*****] x [*****] = $[*****]),
(ii) the royalties with respect to the next $[*****] at the second level percentage of [*****] ($[*****] x [*****] =  $[*****]),
and (iii) the royalties with respect to the final $[*****] at the third level percentage of [*****] ($[*****] x
[*****] = $[*****]), for a total royalty amount
of $51,000,000.

 

(c)           In-Licenses.  If either Royalty Payor enters into an
In-License at any time after the Effective Date and during the Term pursuant
to, and in accordance with, the provisions of Section 2.8 or 2.9 hereof, then,
other than royalties with respect to [*****],
which shall be treated as specified below, (i) Fovea shall be responsible for
paying any royalties under such In-License that are due as a result of the
Development, Manufacture or Commercialization of the Product in the Field in
the Fovea Territory by Fovea and its Related Parties, (ii) Dyax shall be
responsible for paying any royalties under such In-License that are due as a
result of the Development, Manufacture or Commercialization of the Product in
the Field in the Dyax Territory by Dyax and its Related Parties, (iii) Dyax
shall be responsible for paying any royalties under such In-License that are
due as a result of the Development, Manufacture or Commercialization of the
Product outside the Field in the Dyax Territory and/or Fovea Territory by Dyax
and its Related Parties, and (iv) Dyax shall be responsible for paying any
royalties under such In-License that are due as a result of the Development,
Manufacture or Commercialization of the Compound or any product (other than the
Product) containing the Compound in any field in the Dyax Territory and/or
Fovea Territory by Dyax, its Related Parties and the Other Related Dyax
Licensees.  [*****] the royalties actually paid by each Royalty Payor under
any In-License of Blocking Third Party Patent Rights (but not any other
In-License) signed by either Party in connection with any Net Sales of the
Product shall offset any royalties otherwise payable by such Royalty Payor
under Sections 7.1(a) or 7.1(b) hereof in connection with such Net Sales of the
Product; provided, however, that in no event shall the
royalties payable by either Royalty Payor for any calendar quarter under
Sections 7.1(a) or 7.1(b) hereof be reduced in aggregate, through all
applicable reductions set forth in this Section 7.1(c), by more than [*****].  In the event that any reduction is limited by
the proviso at the end of the immediately preceding sentence, the applicable
Royalty Payor shall be entitled to carry the unused portion of such reduction 

 

* Confidential
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filed with the Commission.

 

31

 

forward to subsequent calendar quarters, subject to the application of
the limitation set forth in such proviso to such subsequent calendar
quarters.  [*****]

 

(d)           Reduction of Royalty Rates.

 

(i)            In the event that, at any
time during the Term, Dyax or any of its Related Parties or any of the Other
Related Dyax Licensees engages in Commercialization in the United States of any
Competing Product delivered via the same method of delivery used to deliver the
Product in any indication within the Field for which Regulatory Approval for
such Product has been received in the United States, for so long as such
Commercialization continues, the royalty rates that would otherwise be
applicable to the royalties that Fovea is required to pay to Dyax under this
Agreement shall automatically be reduced by [*****].

 

(ii)           If, during a given calendar
quarter there is Generic Competition in a particular country of the Fovea
Territory, then, for each such country in which there is Generic Competition,
the royalties payable pursuant to Section 7.1 shall be reduced, on an
indication-by-indication and country-by-country basis, for such calendar
quarter as follows:

 

	
  Share of Market Held by
  Generic Product (by unit)

  	
   

  	
  Royalty
  Reduction

  	
   

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  

 

(e)           [*****] Royalty.  Notwithstanding any other provision hereof,
in addition to the royalties due as set forth above, and without application of
any offsets as provided in Section 7.1(c) above, each Party shall be
responsible for any royalty due as a result of activities under the [*****] License Agreement or the [*****] Patent Rights as follows:

 

[*****]

 

(f)            Royalty Term. The royalty payment
obligations of each Royalty Payor with respect to Section 7.1(e) shall continue
for so long as payment are required under the relevant license under [*****] Patent Rights.  The royalty payment obligations of each
Royalty Payor with respect to the Product pursuant to this Section 7.1 (other
than Section 7.1(e)) shall commence in each country of the Territory on the
first anniversary of the First Commercial Sale of the Product in such country
and shall continue until the later of [*****]
(each such period, a “Royalty Term”), subject to the following
conditions:

 

(i)            no royalties shall be due
upon the sale or other transfer among a Party or its Related Parties, but in
such cases the royalty shall be due and calculated upon the Party’s or its
Related Party’s Net Sales to the first independent Third Party;

 

(ii)           no royalties shall accrue on
the sale or other disposition of the Product by the Parties or their Related
Parties for use in a Clinical Study or any other Development activities
permitted herein; and

 

* Confidential
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filed with the Commission.

 

32

 

(iii)          no royalties shall accrue on
the disposition of the Product in reasonable quantities by a Party or its
Related Parties as samples (promotion or otherwise) or as donations (for
example, to non-profit institutions or government agencies for a non-commercial
purpose).

 

Section 7.2            Royalty Reports and Payments.  Within [*****]
after the end of each calendar quarter for which royalties are payable
by a Royalty Payor to a Royalty Recipient with respect to Net Sales pursuant to
Section 7.1, such Royalty Payor shall submit to such Royalty Recipient a
report, on a country-by-country basis, providing in reasonable detail an
accounting of all Net Sales (including an accounting of all unit sales of the
Product) made during such calendar quarter in its Territory and the calculation
of the applicable royalties due to the other Party under Section 7.1, [*****] Concurrently with the
submission of such report, such Royalty Payor shall pay to such Royalty
Recipient all royalties payable by it under Section 7.1 [*****]

 

Section 7.3            Non-Royalty In-License
Payments.

 

(a)           Subject to the provisions of Section 7.3(b) below,
the non-royalty fees and payments due under any In-License that is entered into
by either Party at any time after the Effective Date and during the Term shall
be [*****].  Notwithstanding anything express or implied
in the foregoing provisions of this Section 7.3(a) to the contrary, the
provisions of this Section 7.3(a) shall not apply to any non-royalty fees and
payments subject to the provisions of Section 7.3(b) below.

 

(b)           Any non-royalty fees and payments due with respect
to the Initial Finished Product under any In-License that is entered into by
Fovea pursuant to Section 2.8 at any time after the Effective Date shall be [*****]

 

(c)           For purposes of clarification, the provisions of
this Section 7.3 shall not apply to any in-license that is in effect on the
Effective Date and, except as expressly provided herein with respect to the [*****] License Agreement, each Party
shall be responsible for any obligations under any such in-license to which it
is a party on the Effective Date.

 

Section 7.4             Audits.  Each Party shall keep complete and accurate
records of the underlying patent and trademark expenses, Net Sales and
in-license royalties and non-royalty payments relating to the reports and
payments required by Sections 7.1, 7.2 and 7.3,.  Each Party will have the right [*****]at its own expense to have an
independent, certified public accountant, selected by such Party and reasonably
acceptable to the other Party, review any such records of the other Party in
the location(s) where such records are maintained by the other Party upon
reasonable notice and during regular business hours and under obligations of
confidentiality, for the sole purpose of verifying the basis and accuracy of
payments made under Sections 7.1, 7.2 and7.3 within the prior [*****] period.  If the review of such records reveals that
the other Party has failed to accurately report information pursuant to Section
7.1, 7.2 and 7.3, then the other Party shall promptly pay to the auditing Party
any resulting amounts due under Section 7.1, 7.2 and 7.3, as the case may be,
together with interest calculated in the manner provided in Section 7.9.  If any such under payments are greater than [*****] of the amounts actually due
for a calendar quarter under Section 7.1, 7.2 and 7.3, [*****] the other Party shall pay all of the costs of such
review.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

33

 

 

Section 7.5                                      Tax Matters.  If laws, rules or regulations require
withholding of income taxes or other taxes imposed upon payments set forth in
this Article VII, the Royalty Payor shall make such withholding payments as
required and subtract such withholding payments from the payments set forth in
this Article VII.  The Royalty Payor
shall submit appropriate proof of payment of the withholding taxes to the
Royalty Recipient within a reasonable period of time.  At the request of the Royalty Recipient, the
Royalty Payor shall, at its cost, give the Royalty Recipient such reasonable
assistance, which shall include the provision of appropriate certificates of
such deductions made together with other supporting documentation as may be
required by the relevant tax authority, to enable the Royalty Recipient to
claim exemption from such withholding or other tax imposed or obtain a
repayment thereof or reduction thereof and shall upon request provide such
additional documentation from time to time as is reasonably required to confirm
the payment of tax.

 

Section 7.6                                      United States
Dollars.  All dollar ($) amounts
specified in this Agreement are United States dollar amounts.

 

Section 7.7                                      Currency
Exchange.  With
respect to Net Sales invoiced or expenses incurred in U.S. dollars, the Net
Sales or expense amounts and the amounts due to the receiving Party hereunder
shall be expressed in U.S. dollars.  With
respect to Net Sales invoiced or expenses incurred in a currency other than
U.S. dollars, the Net Sales or expense shall be expressed in the currency in
which such Net Sales were invoiced or such expense was incurred together with
the U.S. dollar equivalent, calculated using the average of the spot rate on
the first and last business days of the calendar quarter in which the Net Sales
were made or the expense was incurred. 
The “closing mid-point rates” found in the “dollar spot forward against
the dollar” table published by The Financial Times or any other publication as
agreed to by the Parties shall be used as the source of spot rates.  All payments shall be made in U.S. dollars.

 

Section 7.8                                      Blocked
Payments.  In the
event that, by reason of applicable laws, rules or regulations in any country,
it becomes impossible or illegal for the Royalty Payor or its Related Parties,
to transfer, or have transferred on its behalf, royalties or other payments to
the Royalty Recipient, the Royalty Payor shall promptly notify the Royalty
Recipient of the conditions preventing such transfer and such royalties or
other payments shall be deposited in local currency in the relevant country to
the credit of the Royalty Recipient in a recognized banking institution
designated by the Royalty Recipient or, if none is designated by the Royalty
Recipient within a period of thirty (30) days, in a recognized banking
institution selected by the Royalty Payor or its Related Party, as the case may
be, and identified in a notice given to the Royalty Recipient.

 

Section 7.9                                      Late Payments.  The Royalty Payor shall pay interest to the
Royalty Recipient on the aggregate amount of any payments that are not paid on
or before the date such payments are due under this Agreement at a rate per
annum equal to the lesser of [*****] per
month or the highest rate permitted by applicable law, calculated on the number
of days such payments are paid after the date such payments are due and
compounded monthly.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

34

 

ARTICLE VIII

INTELLECTUAL
PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

 

Section 8.1                                      Ownership of
Product Intellectual Property.   All Know-How, Patent Rights and other
intellectual property developed through direct or indirect use of the Compound,
or that otherwise claims the Compound or any Product, and that was generated,
developed, conceived or reduced to practice by or on behalf of Fovea or its
Affiliates prior to the Effective Date (including, without limitation, in the
performance of the Research and Option Agreement) (“Fovea-Assigned Intellectual
Property”) shall be owned by Dyax.  Any
and all rights that Fovea or its Related Parties have in or to any such
Fovea-Assigned Intellectual Property shall be assigned to Dyax.  Fovea represents and warrants that it has
taken all steps necessary to transfer and assign ownership in all such
intellectual property to Dyax prior to the Effective Date.  Failure to effectuate such assignment shall
be deemed a material breach of this Agreement.

 

Section 8.2                                      Ownership of
Inventions.

 

(a)                                  Sole Inventions.  Each Party shall exclusively own all
Inventions invented solely by such Party, its Affiliates and its and their
employees, agents, consultants and contractors (“Sole Inventions”).  Sole Inventions invented solely by Fovea, its
Affiliates, and its and their employees, agents, consultants and contractors
are referred to herein as “Fovea Sole Inventions”.  Sole Inventions invented solely by Dyax, its
Affiliates, and its and their employees, agents and consultants are referred to
herein as “Dyax Sole Inventions”.

 

(b)                                 Joint Inventions and Joint
Know-How.  The Parties
shall jointly own all Inventions invented jointly by employees, agents,
consultants, and contractors of Fovea and its Affiliates and employees, agents,
consultants and contractors of Dyax and its Affiliates, on the basis of each
Party having an undivided interest in the whole (“Joint Inventions”).  The Parties shall jointly own all Joint
Know-How and Joint Patent Rights, subject to the rights and obligations
expressly provided herein.

 

(c)                                  Inventorship.  For purposes of determining whether an
Invention is a Fovea Sole Invention, a Dyax Sole Invention or a Joint
Invention, questions of inventorship shall be resolved in accordance with
United States patent laws.

 

Section 8.3                                      Prosecution and
Maintenance of Patent Rights.

 

(a)                                  Solely-Controlled Patent
Rights.  Each Party shall have the
first right and option to prepare, file, prosecute, defend and maintain any
Patent Rights Covering the Product or its use in the Territory that are solely Controlled
by such Party, except that, subject to the provisions of any Third Party
license agreement under which Fovea Controls Patent Rights, Dyax shall have the
first right and option to prepare, file, prosecute and maintain in the name of
Fovea and anywhere in the Territory any Patent Rights Covering a Fovea Sole
Invention that Covers the Compound or that otherwise could, in Dyax’s
reasonable judgment, be material to Dyax’s patent portfolio and strategy for
the Compound.  The Party with such first
right shall be referred to as the “Controlling Party”.  If the Controlling Party elects not to
undertake the filing, prosecution, defense and/or maintenance (or, after
commencement of such filing, prosecution, defense and/or maintenance, desires
to cease the prosecution or the maintenance) of any Patent Rights that the
Controlling Party has the right to prepare, file, prosecute, defend and
maintain pursuant to the immediately preceding sentence, then the Controlling
Party shall notify the non-Controlling Party of such election and, subject to
the provisions of any Third Party license agreement 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

35

 

under which the Controlling Party Controls such Patent Rights, the
non-Controlling Party shall be entitled (but not obligated), in the name of the
Controlling Party, to file, prosecute, defend and/or maintain such Patent
Rights in the non-Controlling Party’s Territory; provided, however,
that Fovea shall have no such rights with respect to any Core Dyax Patent
Rights (as defined below) in any country. 
For purposes of this Agreement, the term “Core Dyax Patent Rights” shall
mean Dyax Patent Rights or Joint Patent Rights that Cover the Compound or its
use or that otherwise could, in Dyax’s reasonable judgment, be material to Dyax’s
patent portfolio and strategy for the Compound.

 

(b)                                 Joint Patent Rights.  Dyax shall have the first right and option to
prepare, file, prosecute, defend and maintain the Joint Patent Rights.  If Dyax elects not to undertake (or, after
commencement of such filing, prosecution and/or maintenance, desires to cease
the prosecution or the maintenance of) any Joint Patent Rights in the Fovea
Territory, then Dyax shall notify Fovea of such election and Fovea shall be
entitled (but not obligated) to prepare, file, prosecute, defend and/or
maintain such Joint Patent Rights in the names of both Parties; provided, however,
that Fovea shall have no such rights with respect to any Core Dyax Patent
Rights in any country.

 

(c)                                  Costs and Expenses.

 

(i)                                     Fovea. Fovea shall
bear its own costs and expenses incurred in preparing, filing, prosecuting,
defending and/or maintaining those Dyax Patent Rights and Fovea Patent Rights
(but not Joint Patent Rights) that Fovea actually prepares, files, prosecutes,
defends and/or maintains after implementing and giving full effect to the
provisions of Section 8.3(a) above.

 

(ii)                                  Dyax. Dyax shall
bear its own costs and expenses incurred in preparing, filing, prosecuting,
defending and/or maintaining those Dyax Patent Rights and Fovea Patent Rights
(but not Joint Patent Rights) that Dyax actually prepares, files, prosecutes,
defends and/or maintains after implementing and giving full effect to the provisions
of Section 8.3(a) above.

 

(iii)                               Joint Patent
Rights. Dyax and Fovea shall share all reasonable, documented external and
out-of-pocket costs and expenses actually incurred by either Party in
connection with preparing, reviewing, commenting, filing, prosecuting,
defending and/or maintaining the Joint Patent Rights.  Each Party shall provide to the other Party
copies of invoices or other documentation reasonably evidencing such external
and out-of-pocket expenses and the Party that is responsible for preparing,
filing, prosecuting, defending and/or maintaining the applicable Joint Patent
Rights pursuant to Section 8.3(b) shall notify the other Party of the amount
that either Party needs to reimburse the other Party in order for both Parties
to share such external and out-of-pocket costs and expenses as contemplated in
this Section 8.3(c)(iii).  Either Party
required to reimburse the other Party as contemplated under this Section 8.3(c)(iii)
shall be obligated to do so within [*****]
after the notification contemplated in the immediately preceding
sentence is given.

 

(d)                                 Cooperation. The Party
having the right to prosecute and maintain patents under this Section 8.3 shall
be referred to as the “Prosecuting Party”. Each Party agrees to
cooperate with the other with respect to the preparation, filing, prosecution,
defense and maintenance of patents and patent applications pursuant to this Section
8.3, and will perform such lawful acts and execute such documents in order to
reasonably assist the Prosecuting Party in connection therewith.  Dyax, as the Prosecuting 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

36

 

Party, shall (i) keep Fovea fully informed as to the filing, prosecution,
maintenance, defense and enforcement of (1) Fovea Patent Rights as to which
Dyax is the Controlling Party pursuant to Section 8.3(a), (2) Joint Patent
Rights and (3) Dyax Patent Rights claiming the Product or the use of the
Compound or Product in the Field that are being or will be filed, prosecuted,
defended or maintained by Dyax pursuant to Section 8.3 in the Fovea Territory, (ii)
furnish to Fovea copies of all material filings as well as copies of all
material correspondence from the relevant patent office, in each case relating
to any such filing, prosecution, defense, maintenance and enforcement, and (iii)
allow Fovea [*****] to review
and comment upon, and to consider and incorporate in good faith its reasonable
comments into, any such document filed with any patent office prior to filing
such documents.  This provision shall
apply mutatis mutandis to Fovea
as the Prosecuting Party with respect to (1) Fovea Patent Rights subject to the
provisions of Section 8.3(a) and as to which Dyax is not the Controlling Party,
(2) Joint Patent Rights, and (3) Dyax Patent Rights claiming the Product or the
use of the Compound or Product in the Field that are being or will be filed,
prosecuted, defended or maintained by Fovea in the Fovea Territory pursuant to Section
8.3(a) or (b).

 

(e)                                  Core Dyax Patent Rights.   In addition to its obligations under Section
8.3(d), Dyax shall use Diligent Efforts to prepare, file, prosecute and
maintain the Core Dyax Patent Rights so as to provide commercially reasonable
protection for Products in the Field in the Fovea Territory and the Dyax
Territory and shall confer with and keep Fovea reasonably informed regarding
the status of such activities.

 

Section 8.4                                      Third Party
Infringement.

 

(a)                                  Notice.  Each Party shall promptly report in writing
to the other Party during the Term any known or suspected (i) infringement of
any of the Dyax Patent Rights, Fovea Patent Rights or Joint Patent Rights or (ii)
unauthorized use of any of the Dyax Know-How, Fovea Know-How or Joint Know-How
of which such Party becomes aware, in the case of either clause (i) or clause (ii)
involving the Development, Manufacture or Commercialization by a Third Party of
a competing product in the Field (a “Competitive Infringement”) in the
other Party’s Territory, and shall provide the other Party with all available
evidence supporting such known or suspected infringement or unauthorized use.

 

(b)                                 Initial Right to Enforce.  Subject to Section 8.4(c) below and the
provisions of any Third Party license agreement under which Dyax’s rights in
Dyax Patent Rights or Fovea’s rights in Fovea Patent Rights are granted, (i) Dyax
shall have the first right to initiate a suit or take other appropriate action
that it believes is reasonably required to protect (i.e., prevent or abate
actual or threatened infringement or misappropriation of) or otherwise enforce
the Dyax Intellectual Property and the Joint Intellectual Property in the
Territory and (ii) Fovea shall have the first right to initiate a suit or take
other appropriate action that it believes is reasonably required to protect
(i.e., prevent or abate actual or threatened infringement or misappropriation
of) or otherwise enforce the Fovea Intellectual Property in the Territory.

 

(c)                                  Step-In Right.  Subject to the provisions of any Third Party
license agreement under which Dyax’s rights in Dyax Patent Rights are granted
or Fovea’s rights in Fovea Patent Rights are granted, if the Party with the
first right to enforce (the “Initial Enforcement Rights Party”) the Dyax
Intellectual Property, the Fovea Intellectual Property or the Joint
Intellectual Property fails to initiate a 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

37

 

suit or take other appropriate action that it has the initial right to
initiate or take pursuant to Section 8.4(b) above with respect to a Competitive
Infringement in the other Party’s Territory within [*****] after becoming aware of the basis for such suit or
action, then the other Party (the “Secondary Enforcement Rights Party”)
may, in its discretion, provide the Initial Enforcement Rights Party with
written notice of such Secondary Enforcement Rights Party’s intent to initiate
a suit or take other appropriate action with respect to such Competitive
Infringement in the Secondary Enforcement Rights Party’s Territory.  If the Secondary Enforcement Rights Party
provides such notice and the Initial Enforcement Rights Party fails to initiate
a suit or take such other appropriate action within thirty (30) days after
receipt of such notice from the Secondary Enforcement Rights Party, then the
Secondary Enforcement Rights Party shall have the right to initiate a suit or
take other appropriate action that it believes is reasonably required to
protect the applicable Dyax Intellectual Property, the applicable Fovea
Intellectual Property or the Joint Intellectual Property from such Competitive
Infringement in the Secondary Enforcement Rights Party’s Territory.  Notwithstanding anything to the contrary
contained in this Section 8.4(c) or elsewhere, if Dyax fails to initiate a suit
or take other appropriate action that it has the initial right to initiate or
take pursuant to Section 8.4(b) above with respect to any Competitive Infringement
involving the Core Dyax Patent Rights, then, with respect to such Core Dyax
Patent Rights, (i) Fovea shall have no rights to initiate a suit or take other
action with respect to such Competitive Infringement in any country and (ii) each
country of the Fovea Territory in which such Core Dyax Patent Rights have been
filed or issued and in which such Competitive Infringement exists shall be
treated, for purposes of Section 7.1(d)(ii), as if there is Generic Competition
in such country.

 

(d)                                 Conduct of Certain Actions;
Costs.  The Party initiating suit
shall have the sole and exclusive right to select counsel for any suit
initiated by it pursuant to Section 8.4(b) or 8.4(c).  If required under applicable law in order for
the initiating Party to initiate and/or maintain such suit, the other Party
shall join as a party to the suit.  Such
other Party shall offer reasonable assistance to the initiating Party in
connection therewith at no charge to the initiating Party except for
reimbursement of reasonable out-of-pocket expenses incurred in rendering such
assistance.  The initiating Party shall
assume and pay all of its own out-of-pocket costs incurred in connection with
any litigation or proceedings initiated by it pursuant to Sections 8.4(b) and
8.4(c), including without limitation the fees and expenses of the counsel
selected by it.  The other Party shall
have the right to participate and be represented in any such suit that is based
on a Competitive Infringement by its own counsel at its own expense.

 

(e)                                  Recoveries.  With respect to any suit or action referred
to in Sections 8.4(b) and 8.4(c) that is based on a Competitive Infringement in
the Territory, any recovery obtained as a result of any such proceeding, by
settlement or otherwise, shall be applied in the following order of priority:

 

(i)                                     first, [*****]; and

 

(ii)                                  second, [*****].

 

Section 8.5                                      Claimed
Infringement.  In the
event that a Party becomes aware of any claim that the practice by either Party
of Dyax Intellectual Property, Fovea Intellectual Property or Joint
Intellectual Property in the Development, Manufacture or Commercialization of
the Product infringes the intellectual property rights of any Third Party, such
Party shall promptly notify the other Party. 
In any such instance, 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

38

 

the Parties shall cooperate and shall
mutually agree upon an appropriate course of action.  Each Party shall provide to the other Party
copies of any notices it receives from Third Parties regarding any patent
nullity actions, any declaratory judgment actions and any alleged infringement
or misappropriation of Third Party intellectual property relating to the
Development, Manufacture or Commercialization of the Product.  Such notices shall be provided promptly, but
in no event after more than [*****] following
receipt thereof.

 

Section 8.6                                      Patent Term
Extensions.  The Parties
shall cooperate, if necessary and appropriate, with each other in gaining
patent term extensions wherever applicable in the Territory to Patent Rights
Controlled by either Party that Cover the Product.  The Parties shall, if necessary and
appropriate, [*****].

 

Section 8.7                                      Patent Marking.  Each Party agrees to comply with the patent
marking statutes in each country in its Territory in which the Product is sold
by such Party and/or its Related Parties.

 

Section 8.8                                      Trademarks.

 

(a)                                  Each Party and
its Affiliates shall retain all right, title and interest in and to its and
their respective corporate names and logos.

 

(b)                                 The Parties
shall develop and propose, and the JSC shall consider and approve, one or more
Product Trademark(s) for use throughout the Territory (“Global Trademarks”).  The Product shall be promoted and sold, in
accordance with the provisions of this Agreement, in the Fovea Territory under
a Global Trademark unless such Global Trademark cannot be legally used to
promote and sell the Product in the Fovea Territory, in which case an
alternative Product Trademark proposed by Fovea and approved by Dyax (which
approval shall not be unreasonably withheld or delayed) (a “Fovea Trademark”),
shall be used in the Fovea Territory. 
The Product shall be promoted and sold, in accordance with the
provisions of this Agreement, in the Dyax Territory using the Global Trademark.
Any and all Global Trademarks and Fovea Trademark(s) shall be different from
the trademark(s) and servicemark(s) used by Dyax or its Affiliates or
sublicensees to promote and sell products containing the Compound other than
the Product in or outside the Territory. 
Dyax (or its local Affiliates, as appropriate) shall own all rights to
Global Trademarks, and all goodwill associated therewith throughout the Territory
and Fovea shall own all rights to Fovea Trademarks and associated goodwill in
the Fovea Territory.  Dyax shall also own
rights to any Internet domain names incorporating the applicable Global
Trademarks, or any variation or part of such Global Trademarks, as its URL
address or any part of such address; and Fovea shall also own rights to any
Internet domain names incorporating the applicable Fovea Trademarks or any
variation or part of such Fovea Trademarks as its URL address or any part of
such address.

 

(c)                                  If Global Trademarks are
used by Fovea to promote and sell the Product in the Fovea Territory, then the
following provisions shall apply:  Dyax
shall grant Fovea an exclusive license (including the right to grant
sublicenses) to use the Global Trademarks to Commercialize the Product in the
Fovea Territory.  Fovea agrees that the
quality of the Product and the Manufacture and Commercialization thereof shall
be consistent with customary standards of quality in the biopharmaceuticals
industry.  In addition, Fovea shall
comply strictly with Dyax’s trademark style and usage standards that Dyax
communicates to Fovea from time to time with respect to the Global 

 

* Confidential
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filed with the Commission.

 

39

 

Trademarks.  Fovea shall at its
own expense, at the request of Dyax from time to time, submit to Dyax for
approval a reasonable number of production samples of the Product and related
packaging materials.  In the event that
Dyax reasonably objects to the usage of the Global Trademarks owned by it in
connection with any sample, it shall give written notice of such objection to
Fovea within [*****] of receipt
by Dyax of the sample, specifying the way in which such usage of its Global
Trademarks fails to meet the style, usage or quality standards for the Product
set forth in the first two sentences of this Section 8.8(c), and, if and to the
extent so requested by Dyax, Fovea shall immediately cease sale and
distribution of the Product.  If Fovea
has ceased sale and distribution of the Product pursuant to the immediately
preceding sentence and wishes to continue to distribute and sell the Product,
it must remedy the failure and submit further samples to Dyax for approval.

 

(d)                                 Dyax will use
Diligent Efforts to establish, maintain and enforce the Global Trademarks
during the Term, provided that, at the election of Fovea, Fovea shall
have the right to enforce the Global Trademarks (if being used by Fovea)
against an infringer thereof in the Fovea Territory if such infringement is
limited only to the Fovea Territory and if Dyax reasonably agrees that such
action would not jeopardize the Global Trademark in any jurisdiction outside
the Fovea Territory.  [*****]

 

(e)                                  In the event
either Party becomes aware of any infringement of any Product Trademark by a
Third Party, such Party shall promptly notify the other Party and the Parties
shall consult with each other and jointly determine the best way to prevent
such infringement, including, without limitation, by the institution of legal
proceedings against such Third Party.

 

ARTICLE IX

CONFIDENTIALITY
AND PUBLICITY

 

Section 9.1                                      Confidential
Information.  During the
Term and for [*****] after any
termination or expiration thereof, each Party agrees to keep in confidence and
not to disclose to any Third Party, or use for any purpose, except pursuant to,
and in order to carry out, the terms and objectives of this Agreement, any
Confidential Information of the other Party. 
As used herein, “Confidential Information” shall mean all trade
secrets or confidential or proprietary information designated as such in
writing by the disclosing Party, whether by letter or by the use of an
appropriate stamp or legend, prior to or at the time any such trade secret or
confidential or proprietary information is disclosed by the disclosing Party to
the receiving Party.  Notwithstanding the
foregoing, information which is orally or visually disclosed to the receiving
Party by the disclosing Party, or is disclosed in writing without an
appropriate letter, stamp or legend, shall constitute Confidential Information
if (x) it would be apparent to a reasonable person, familiar with the
disclosing Party’s business and the industry in which it operates, that such
information is of a confidential or proprietary nature, the maintenance of
which is important to the disclosing Party, or if (y) the disclosing Party,
within [*****] after such
disclosure, delivers to the receiving Party a written document or documents
describing such information and referencing the place and date of such oral,
visual or written disclosure and the names of the employees or officers of the
receiving Party to whom such disclosure was made.  The restrictions on the disclosure and use of
Confidential Information set forth in the first sentence of this Section 9.1
shall not apply to any Confidential Information that:

 

* Confidential
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40

 

(a)                                  was known by the receiving
Party prior to disclosure by the disclosing Party hereunder (as evidenced by
the receiving Party’s written records);

 

(b)                                 is or becomes part of the
public domain through no fault of the receiving Party;

 

(c)                                  is disclosed to the
receiving Party by a Third Party having a legal right to make such a disclosure
without violating any confidentiality or non-use obligation that such Third
Party has to the disclosing Party; or

 

(d)                                 is independently developed
by the receiving Party (as evidenced by the receiving Party’s written records).

 

Notwithstanding the obligations of confidentiality
and non-use set forth above, a receiving Party may provide Confidential
Information disclosed to it to (i) governmental or other Regulatory Authorities
in order to obtain patents or to gain or maintain approval to conduct Clinical
Studies or to otherwise Develop, Manufacture or Commercialize the Product in
accordance with this Agreement; provided,
that such disclosure shall be subject to the prior written consent of the Party
whose Confidential Information is intended to be disclosed (which consent shall
not be unreasonably withheld or delayed), and such Confidential Information
shall be disclosed only to the extent reasonably necessary to obtain patents or
authorizations in a manner consistent with the rights and obligations
hereunder, (ii) the extent required by applicable law, including without
limitation by the rules or regulations of the United States Securities and
Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange or listing entity, (iii) any bona fide
actual or prospective underwriters, investors, lenders or other financing
sources or bona fide actual or prospective collaborators, strategic partners or
acquirors who are obligated to keep such information confidential, to the
extent reasonably necessary to enable such actual or prospective underwriters,
investors, lenders or other financing sources, collaborators, strategic
partners or acquirors to determine their interest in underwriting or making an
investment in, or otherwise providing financing to, collaborating or partnering
with, or acquiring, the receiving Party. 
In addition, if either Party is required to disclose Confidential
Information of the other Party by regulation, law or legal process, including
without limitation by the rules or regulations of the United States Securities
and Exchange Commission or similar regulatory agency in a country other than
the United States or of any stock exchange or listing entity, such Party shall
provide prior notice of such intended disclosure to such other Party if
practicable under the circumstances and shall disclose only such Confidential
Information of such other Party as is required to be disclosed.

 

Section 9.2                                      Related Party,
Employee, Consultant and Advisor Obligations.  Each Party agrees that it and its Affiliates
shall provide or permit access to Confidential Information received from the
other Party only to the receiving Party’s Related Parties, employees,
consultants, advisors and permitted subcontractors, and to the employees,
consultants, advisors and permitted subcontractors of the receiving Party’s
Related Parties, who have a need to know such Confidential Information to
assist the receiving Party with the Development, Manufacturing and
Commercialization of the Product in accordance with this Agreement and the
activities contemplated by this Agreement and who are subject to obligations of
confidentiality and non-use with respect to such Confidential Information similar
to the obligations of confidentiality and non-use of the receiving Party
pursuant to Section 9.1; provided,
that Dyax and Fovea shall each remain responsible for any failure by its
Affiliates, and its and its Affiliates’ 

 

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respective employees, consultants, advisors
and permitted subcontractors, sublicensees and sub-distributors, to treat such
Confidential Information as required under Section 9.1 (as if such Affiliates,
employees, consultants, advisors and permitted subcontractors, sublicensees and
sub-distributors were Parties directly bound to the requirements of Section 9.1).

 

Section 9.3                                      Publicity.  Following the execution of this Agreement,
the Parties shall at a mutually agreeable time issue a mutually agreeable joint
press release regarding the subject matter of this Agreement.  After such initial joint press release,
neither Party shall issue a press release or public announcement relating to
the Product or this Agreement without the prior written approval of the other
Party, which approval shall not be unreasonably withheld, except that a Party
may (a) issue such a press release or public announcement if the contents of
such press release or public announcement have previously been made public
other than through a breach of this Agreement by the issuing Party; and (b) issue
such a press release or public announcement if required by applicable
regulation or law, including without limitation by the rules or regulations of
the United States Securities and Exchange Commission or similar regulatory
agency in a country other than the United States or of any stock exchange or
listing entity; provided that the
other Party has received prior notice of such intended press release or public
announcement if practicable under the circumstances and, with respect to press
releases and public announcements made pursuant to the foregoing clause (b),
the Party subject to the requirement includes in such press release or public
announcement only such information relating to the Product or this Agreement as
is required by such applicable regulation or law.

 

Section 9.4                                      Publications.  Subject to the restrictions provided below,
either Party may publish or present the results of Development carried out on
the Product in accordance with this Agreement, subject to the prior review by
the other Party for patentability and protection of such other Party’s
Confidential Information.  Each Party shall
provide to the other Party the opportunity to review and approve any proposed
abstracts, manuscripts or summaries of presentations that cover the results of
Development of the Product.  Each Party
shall designate a Person or Persons who shall be responsible for approving such
publications.  Such designated person
shall respond in writing promptly and in no event later than [*****] after receipt of the proposed
material with either approval of the proposed material or a specific statement
of concern, based upon either the need to seek patent protection or concern
regarding competitive disadvantage arising from the proposal.  In the event of concern, the submitting Party
agrees not to submit such publication or to make such presentation that
contains such information until the other Party is given a reasonable period of
time (not to exceed [*****]) to
seek patent protection for any material in such publication or presentation
that it believes is patentable or to resolve any other issues, and the
submitting Party shall remove from such proposed publication any Confidential
Information of the other Party as requested by such other Party.  With respect to any proposed abstracts,
manuscripts or summaries of presentations by investigators or other Third
Parties, such materials shall be subject to review under this Section 9.4 to
the extent that Dyax or Fovea, as the case may be, has the right to do so.

 

ARTICLE X

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS;
INDEMNIFICATION

 

Section 10.1                                Exclusivity
Covenant. During the Term, Fovea and its Related Parties
shall refrain from engaging in clinical Development or Commercialization of a
Competing Product in the Field 

 

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or outside the Field anywhere in the world,
subject to the provisions set forth below in this Section 10.1.    During the Term, Dyax and its Related
Parties and the Other Related Dyax Licensees shall refrain from engaging in
clinical Development or Commercialization of a Competing Product for use in the
Field in the Fovea Territory. 
Notwithstanding anything express or implied in the foregoing provisions
of this Section 10.1 to the contrary, this Section 10.1 shall not restrict or
limit Fovea from Developing or Commercializing, and Fovea shall have the right
to Develop and Commercialize, any product for use as a therapeutic for
ophthalmic diseases or conditions in humans that [*****].

 

Section 10.2                                Representations
of Authority.  Dyax and
Fovea each represents and warrants to the other Party that, as of the Effective
Date, it has full corporate right, power and authority to enter into this
Agreement and to perform its respective obligations under this Agreement and
that it has the right to grant to the other the licenses and sublicenses
granted pursuant to this Agreement.

 

Section 10.3                                Consents.  Dyax and Fovea each represents and warrants
to the other Party that, except for any Regulatory Approvals, pricing and/or
reimbursement approvals, manufacturing approvals and/or similar approvals
necessary for the Development, Manufacture or Commercialization of the Product,
all necessary consents, approvals and authorizations of all government
authorities and other persons required to be obtained by it as of the Effective
Date in connection with the execution, delivery and performance of this
Agreement have been obtained by the Effective Date.

 

Section 10.4                                No Conflict.  Dyax and Fovea each represents and warrants
to the other Party that, notwithstanding anything to the contrary in this
Agreement, the execution and delivery of this Agreement by such Party, the
performance of such Party’s obligations hereunder and the licenses and
sublicenses to be granted by such Party pursuant to this Agreement (a) do not
conflict with or violate any requirement of any laws, rules or regulations
existing as of the Effective Date and applicable to such Party and (b) do not
conflict with, violate, breach or constitute a default under any contractual obligations
of such Party or any of its Affiliates existing as of the Effective Date.

 

Section 10.5                                Enforceability.  Dyax and Fovea each represents and warrants
to the other Party that, as of the Effective Date, this Agreement is a legal
and valid obligation binding upon it and is enforceable against it in
accordance with its terms, except as such enforceability may be limited by
applicable insolvency and other applicable laws affecting creditors’ rights
generally or by the availability of equitable remedies.

 

Section 10.6                                No Debarment.  Dyax and Fovea each represents and warrants
to the other Party that, as of the Effective Date, neither Party nor any of its
Affiliates has been debarred or is subject to debarment and that neither Party
nor any of its Affiliates has used or will use in any capacity, in connection
with the Development, Manufacture or Commercialization of the Product, any
Person who has been debarred pursuant to Section 306 of the United States
Federal Food, Drug, and Cosmetic Act, or who is the subject of a conviction
described in such section.  Each Party
agrees to inform the other Party in writing immediately if it or any Person who
is performing the activities under this Agreement is debarred or is the subject
of a conviction described in Section 306, or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to the best
of the notifying Party’s knowledge, is threatened, relating to the debarment or
conviction of the notifying Party or any Person

 

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used in any capacity by the notifying Party
or any of its Affiliates in connection with the Development, Manufacture or
Commercialization of the Product.

 

Section 10.7                                Additional
Representations and Warranties of Dyax.  Dyax represents and warrants to Fovea that,
as of the Effective Date:

 

(a)                                  Dyax has not granted any
license to any Third Party under any of the Dyax Intellectual Property to
Develop, Manufacture or Commercialize the Product in the Field.

 

(b)                                 Except for non-exclusive
licenses granted by Dyax to its Affiliates and to Third Parties, which grants
do not conflict with the license grants to Fovea hereunder, to the best of its
knowledge, (i) Dyax is the sole and exclusive owner of all right, title and
interest in and to the Patent Rights listed on Exhibit C-1 (the “Existing Dyax
Patent Rights”) and (ii) other than the Existing Dyax Patent Rights and the
Fovea-Assigned Patent Rights, there are no other Dyax Patent Rights as of the
Effective Date.

 

(c)                                  Neither Dyax nor any of its
Affiliates is or has been a party to any agreement with the U.S. federal
government or an agency thereof pursuant to which the U.S. federal government
or such agency provided funding for the Development of the Compound or the
Product.

 

(d)                                 No claim of infringement of
the Patent Rights of any Third Party has been made, nor to Dyax’s knowledge
threatened, against Dyax or any of its Affiliates or, to the best of Dyax’s
knowledge, any of its Related Parties or any of the Other Related Dyax
Licensees with respect to the Development, Manufacture or Commercialization of
the Compound or the Product, and there are no other claims, judgments or
settlements against or owed by Dyax or any of its Affiliates or, to the best of
Dyax’s knowledge, any of its Related Parties or any of the Other Related Dyax
Licensees or to which Dyax or any of its Affiliates or, to the best of Dyax’s
knowledge, any of its Related Parties or any of the Other Related Dyax
Licensees is a party or, to the best of Dyax’s knowledge, pending or threatened
claims or litigation, in either case relating to the Compound or Product.

 

(e)                                  Prior to the Effective Date
Dyax has provided Fovea with a complete and correct copy of the [*****] License Agreement.  To the best of Dyax’s knowledge, such
agreement remains in full force and effect as of the Effective Date and such
agreement is the only agreement as of the Effective Date between Dyax and any
Third Party that imposes an obligation to pay royalties to a Third Party based
on sales of the Product.

 

Section 10.8                                Additional
Representations and Warranties of Fovea.  Fovea represents and warrants to Dyax that,
as of the Effective Date:

 

(a)                                  It has transferred and
assigned all rights that it or its Affiliates may have in the Fovea-Assigned
Intellectual Property, including without limitation, the Patent Rights listed
on Exhibit C-2 (the “Fovea-Assigned Patent Rights”), to Dyax, in each case free
and clear of all liens, charges and encumbrances, and is not aware of any claim
made against it asserting the invalidity, misuse, unregisterability,
unenforceability or non-infringement of any of such Fovea-Assigned Intellectual
Property or challenging Fovea’s sole Control of such Fovea-Assigned
Intellectual Property, or the 

 

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assignment to Dyax of such Fovea-Assigned Intellectual Property, or
making any adverse claim of ownership or misappropriation thereof.

 

(b)                                 Neither Fovea nor any of its
Affiliates is or has been a party to any agreement with the U.S. federal
government or an agency thereof pursuant to which the U.S. federal government
or such agency provided funding for the Development of the Compound or the
Product.

 

(c)                                  To the best of Fovea’s
knowledge, the Development, Manufacture and Commercialization of the Compound
as conducted by Fovea on or prior to the Effective Date did not infringe,
interfere with or result in the misappropriation of any intellectual property
rights of any Third Party existing as of the Effective Date.

 

(d)                                 No claim of infringement of
the Patent Rights of any Third Party has been made, nor to Fovea’s knowledge
threatened, against Fovea or any of its Affiliates with respect to the
Development, Manufacture or Commercialization of the Compound or the Product,
and there are no other claims, judgments or settlements against or owed by
Fovea or any of its Affiliates or to which Fovea or any of its Affiliates is a
party or, to the best of Fovea’s knowledge, pending or threatened claims or
litigation, in either case relating to the Compound or Product.

 

(e)                                  Fovea has made available to
Dyax all information in its Control relating to the Compound and the
Development, Manufacture and Commercialization of the Compound as conducted by
Fovea to date.

 

(f)                                    All of the studies, tests
and pre-clinical and clinical trials of the Compound conducted prior to, or
being conducted as of, the Effective Date by Fovea have been and are being
conducted in accordance with applicable laws, rules and regulations.

 

(g)                                 There are no agreements
between Fovea and any Third Party that impose an obligation to pay royalties to
a Third Party based on sales of the Product.

 

Section 10.9                                No Warranties.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY, AND EACH PARTY HEREBY
DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT WITH RESPECT TO THE COMPOUND AND THE PRODUCT.  EACH PARTY HEREBY DISCLAIMS ANY
REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE AND
COMMERCIALIZATION OF THE PRODUCT PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL.

 

Section 10.10                          Indemnification.

 

(a)                                  By Fovea. Fovea will
defend, indemnify and hold harmless Dyax, its Related Parties, and their
respective directors, officers, employees and agents (the “Dyax Indemnified
Parties”) from and against all claims, demands, liabilities, damages,
penalties, fines, costs and expenses, including reasonable attorneys’ and
expert fees and costs, and costs or amounts paid to settle (collectively, 

 

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“Losses”), arising from or occurring as a result of a Third
Party’s claim (including any Third Party product liability or infringement
claim), action, suit, judgment or settlement to the extent such Losses are due
to or based upon:

 

(i)                                     the gross
negligence, recklessness, bad faith, intentional wrongful acts or omissions or
violations of applicable law or regulation by or of Fovea, its Related Parties,
wholesale distributors, contractors or their respective directors, officers,
employees or agents, including, without limitation, in connection with the
Development, Manufacture or Commercialization of the Product by Fovea, its
Related Parties, wholesale distributors or contractors; or

 

(ii)                                  the material
breach by Fovea of the terms of, or the material inaccuracy of any
representation or warranty made by it in, this Agreement or any Supply
Agreement; or

 

(iii)                               any
manufacturing defect in any Finished Product supplied to Dyax or its Related
Parties by or on behalf of Fovea; or

 

(iv)                              the
Development, Manufacture and Commercialization of the Product in the Field by
Fovea or its Related Parties, wholesale distributors or contractors, except
to the extent that such Losses arise out of, and are allocable to, (x) the
negligence, recklessness, bad faith, intentional wrongful acts, omissions or
violations of law or breach of this Agreement committed by the Dyax Indemnified
Parties, (y) any manufacturing defect in any API Bulk Drug Substance supplied
to Fovea or its Related Parties by or on behalf of Dyax, (z) any actual or
alleged infringement or misappropriation by Fovea or its Related Parties,
wholesale distributors or contractors of the Patent Rights or Know How of any
Third Party to the extent arising from the composition of matter or use of the
Compound itself in actions undertaken pursuant to, and in accordance with, the
provisions of this Agreement (and not, for clarity, to the extent such actual
or alleged infringement or misappropriation arises from the delivery method or
formulation of the Product that is Developed by Fovea for use in the Field
pursuant to this Agreement or from any combination of the Compound with any
other materials or components that is made by Fovea in the course of Developing
the Product for use in the Field pursuant to this Agreement) or (zz) any liability
for which Dyax is to indemnify Fovea pursuant to Section 10.10(b)(v) below.

 

(b)                                 Dyax will defend, indemnify
and hold harmless Fovea, its Related Parties, and their respective directors,
officers, employees and agents (the “Fovea Indemnified Parties”) from
and against all Losses arising from or occurring as a result of a Third Party’s
claim (including any Third Party product liability or infringement claim),
action, suit, judgment or settlement that is due to or based upon:

 

(i)                                     the gross
negligence, recklessness, bad faith, intentional wrongful acts or omissions or
violations of applicable law or regulation by or of Dyax, its Related Parties,
Other Related Dyax Licensees, wholesale distributors, contractors or their
respective directors, officers, employees or agents, including, without
limitation, in connection with the Development, Manufacture or
Commercialization of the Product, the Compound or any other product containing
the Compound by Dyax, its Related Parties, Other Related Dyax Licensees, wholesale
distributors or contractors; or

 

(ii)                                  material breach
by Dyax of the terms of, or the material inaccuracy of any representation or
warranty made by it in, this Agreement; or

 

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(iii)                               any
manufacturing defect in any API Bulk Drug Substance supplied to Fovea or its
Related Parties by or on behalf of Dyax ; or

 

(iv)                              the
Development, Manufacture and Commercialization of the Product, the Compound or
any product containing the Compound by Dyax or its Related Parties, Other
Related Dyax Licensees, wholesale distributors or contractors, except to the
extent that such Losses arise out of, and are allocable to, (x) the negligence,
recklessness, bad faith, intentional wrongful acts, omissions or violations of
law or breach of this Agreement committed by the Fovea Indemnified Parties, or (y)
any manufacturing defect in any Finished Product supplied to Dyax or its
Related Parties by or on behalf of Fovea, (z) any actual or alleged
infringement or misappropriation by Dyax or its Related Parties or the Other
Related Dyax Licensees of the Patent Rights or Know How of any Third Party to
the extent arising from the use of the Fovea Intellectual Property itself
pursuant to this Agreement (and not to the extent such actual or alleged
infringement or misappropriation arises from the composition of matter or use
of the Compound itself); or

 

(v)                                 any actual or
alleged infringement (including contributory infringement) or misappropriation
of the Patent Rights or Know-How of any Third Party to the extent arising from
the use or practice by Dyax or its Related Parties, Other Related Dyax
Licensees, wholesale distributors or contractors of any Fovea New Outside IP
that is offered to Dyax pursuant to Section 3.2(g) but that is not sublicensed
by Fovea to Dyax by virtue of the provisions of Section 3.2(g) hereof to
Develop, Manufacture or Commercialize the Product, the Compound or any product
containing the Compound.

 

(c)                                  Claims for Indemnification.

 

(i)                                     A person
entitled to indemnification under this Section 10.10 (an “Indemnified Party”)
shall give prompt written notification to the person from whom indemnification
is sought (the “Indemnifying Party”) of the commencement of any action,
suit or proceeding relating to a Third Party claim for which indemnification
may be sought or, if earlier, upon the assertion of any such claim by a Third
Party (it being understood and agreed, however, that the failure by an
Indemnified Party to give notice of a Third-Party claim as provided in this Section
10.10 shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that such
Indemnifying Party is actually prejudiced as a result of such failure to give
notice).

 

(ii)                                  Within [*****] after delivery of such
notification, the Indemnifying Party may, upon written notice thereof to the
Indemnified Party, assume control of the defense of such action, suit, proceeding
or claim with counsel reasonably satisfactory to the Indemnified Party.  If the Indemnifying Party does not assume
control of such defense, the Indemnified Party shall control such defense.

 

(iii)                               The Party not
controlling such defense may participate therein at its own expense; provided, that if the Indemnifying Party
assumes control of such defense and the Indemnified Party reasonably concludes,
based on advice from counsel, that the Indemnifying Party and the Indemnified
Party have conflicting interests with respect to such action, suit, proceeding
or claim, the Indemnifying Party shall be responsible for the reasonable fees
and expenses of counsel to the Indemnified Party solely in connection
therewith; provided  further, however, that in no event shall
the 

 

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Indemnifying Party be responsible for the fees and
expenses of more than one counsel in any one jurisdiction for all Indemnified
Parties.

 

(iv)                              The Party
controlling such defense shall keep the other Party advised of the status of
such action, suit, proceeding or claim and the defense thereof and shall
consider recommendations made by the other Party with respect thereto.

 

(v)                                 The Indemnified
Party shall not agree to any settlement of such action, suit, proceeding or
claim without the prior written consent of the Indemnifying Party, which shall
not be unreasonably withheld or delayed. 
The Indemnifying Party shall not agree to any settlement of such action,
suit, proceeding or claim or consent to any judgment in respect thereof that
does not include a complete and unconditional release of the Indemnified Party
from all liability with respect thereto or that imposes any liability or
obligation on the Indemnified Party without the prior written consent of the
Indemnified Party.

 

Section 10.11                          No
Consequential or Punitive Damages.  NEITHER PARTY HERETO WILL BE LIABLE FOR
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE OR MULTIPLE
DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER,
OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. 
NOTHING IN THIS SECTION 10.11 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD
PARTY CLAIMS OR WITH RESPECT TO A BREACH OF A PARTY’S OBLIGATIONS OF
CONFIDENTIALITY OR NON-USE IN ARTICLE IX. 
For clarity, except as expressly set forth in Section 5.5, neither Party
shall have any liability to the other Party for any Losses resulting from any
clinical hold imposed by a Regulatory Authority, any withdrawal or suspension
by any Regulatory Authority of marketing authorization or other Regulatory
Approval, or any recall required by any Regulatory Authority, in each case with
respect to the Product, or with respect to the Compound outside the Field, as a
result of any safety or efficacy data obtained in connection with the Development
of the Product or any product containing the Compound by either Party or its
Related Parties in accordance with the terms of this Agreement, provided,
however, that the foregoing clause shall not limit liability with
respect to any event that has been caused by, or is the direct result of,  the negligence, recklessness, bad faith,
intentional wrongful acts, omissions or violations of law or breach of this
Agreement committed by the potentially liable Party.

 

ARTICLE XI

TERM AND
TERMINATION

 

Section 11.1                                Term.  Unless terminated earlier in accordance with
this Article XI, this Agreement shall remain in force for the period commencing
on the Effective Date and ending on the expiration of the last Royalty Term to
expire under this Agreement. (the “Term”).

 

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Section 11.2                                Termination
Rights.

 

(a)                                  Termination for Convenience.  Fovea shall have the right to terminate this
Agreement at any time after the Effective Date on [*****] prior written notice to Dyax.

 

(b)                                 Termination For Material
Breach.  Upon any material breach of
this Agreement or any Supply Agreement by a Party (the “Breaching Party”),
the other Party (the “Non-Breaching Party”) may terminate this Agreement
by providing [*****] prior
written notice to the Breaching Party in the case of a breach of a payment
obligation and [*****] written
notice to the Breaching Party in the case of any other material breach.  The termination shall become effective at the
end of the notice period unless the Breaching Party cures such breach during
such notice period; provided that
the Non-Breaching Party may, by notice to the Breaching Party, designate a
later date for such termination in order to facilitate an orderly transition of
activities relating to the Product and such later date shall be the effective
date of such termination if the Breaching Party does not object to such later
date by prompt written notice to the Non-Breaching Party.  Notwithstanding the foregoing, (i) if such
breach, by its nature, is incurable, the Non-Breaching Party may terminate this
Agreement immediately upon written notice to the Breaching Party and (ii) if
such breach (other than a payment breach), by its nature, is curable, but not
within the foregoing cure period, then such cure period shall be extended if
the Breaching Party provides a written plan for curing such breach to the
Non-Breaching Party and uses Diligent Efforts to cure such breach in accordance
with such written plan; provided
that no such extension shall exceed ninety (90) days without the written
consent of the Non-Breaching Party.

 

(c)                                  Termination for Bankruptcy. A Party may
terminate this Agreement should the other Party commit an act of bankruptcy, be
declared bankrupt, voluntarily file or have filed against it a petition for
bankruptcy or reorganization unless such petition is dismissed within [*****] of filing or such petition is
for a reorganization under Chapter 11 of the Bankruptcy Code (as defined below)
or any relevant foreign equivalent thereof and such Party is not in default at
the time of the filing of such petition or at any time during such
reorganization of any of its obligations under this Agreement or any Supply
Agreement, enter into a procedure of winding up to dissolution, or should a
trustee or receiver be appointed for its business assets or operations. All
rights and licenses granted under or pursuant to this Agreement are, and shall
otherwise be deemed to be, for the purposes of Section 365(n) of Title 11, U.S.
Code (“Bankruptcy Code”) license rights to “intellectual property” as
defined under Section 101(60) of the Bankruptcy Code. The Parties agree that
any Party, as a licensee hereunder, shall retain and may fully exercise all of
its rights and elections under the Bankruptcy Code or any relevant foreign
equivalent thereof.

 

(d)                                 Challenges of Patent Rights.  In the event that a Party or any of its
Related Parties (the “Challenging Party”) shall (i) commence or participate
in any action or proceeding (including, without limitation, any patent
opposition or re-examination proceeding), or otherwise assert in writing any
claim, challenging or denying the validity of any of the Patent Rights licensed
to the Challenging Party hereunder, or any claim thereof or (ii) actively
assist any other Person in bringing or prosecuting any action or proceeding
(including, without limitation, any patent opposition or re-examination
proceeding) challenging or denying the validity of any of such Patent Rights or
any claim thereof, the other Party will have the right to give notice to the
Challenging Party (which notice must be given, if at all, within [*****] after the other Party first
learns of the foregoing) that the licenses granted to the Challenging Party to
such Patent Rights will terminate in [*****]
following such notice, and, unless the 

 

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Challenging Party withdraws or causes to be withdrawn all such
challenge(s) within such [*****] period,
such licenses will so terminate.

 

Section 11.3                                Consequences of
Termination.

 

(a)                                  Termination by Dyax for
Cause.   Without limiting any other
legal or equitable remedies that Dyax may have (but subject to the provisions
set forth below in this Section 11.3(a)), if Dyax terminates this Agreement in
accordance with Sections 11.2(b) or (c), then (i) Fovea’s obligations under Section
10.1 shall survive for a period of one (1) year after termination, (ii) Fovea
shall as promptly as practicable transfer to Dyax or Dyax’s designee (A) possession
and ownership of all governmental or regulatory correspondence, conversation
logs, filings and approvals (including all Regulatory Approvals and pricing and
reimbursement approvals) in Fovea’s possession or Control relating to the
Development, Manufacture or Commercialization of the Product and all Fovea
Trademarks then being used or planned for use in connection with the Commercialization
of the Product, (B) copies of all data, reports, records and materials in Fovea’s
possession or Control relating to the Development, Manufacture or
Commercialization of the Product, including all non-clinical and clinical data
relating to the Product, and (C) all records and materials in Fovea’s
possession or Control containing Confidential Information of Dyax, (iii) appoint
Dyax as Fovea’s and/or Fovea’s Related Parties’ agent for all Product-related
matters involving Regulatory Authorities in the Fovea Territory until all
Regulatory Approvals and other regulatory filings have been transferred to Dyax
or its designee, (iv) if the effective date of termination is after First
Commercial Sale, then Fovea shall appoint Dyax as its exclusive distributor of
the Product in the Fovea Territory and grant Dyax the right to appoint
sub-distributors, until such time as all Regulatory Approvals in the Fovea
Territory have been transferred to Dyax or its designee, (v) if Fovea or its
Related Parties are obligated to Manufacture Finished Product for Dyax on the
effective date of such termination, then, at Dyax’s option, supply the Finished
Product to Dyax in the Fovea Territory on terms no less favorable than those on
which Fovea supplied the Finished Product prior to such termination to its most
favored distributor in the Fovea Territory, until such time as all Regulatory
Approvals in the Fovea Territory have been transferred to Dyax or its designee,
Dyax has obtained all necessary manufacturing approvals and Dyax has procured
or developed its own source of Finished Product supply, provided, however,
that such time shall in no event exceed [*****]
unless Fovea or the applicable Related Party otherwise agrees in its
sole and absolute discretion, (vi) if Dyax so requests, Fovea shall transfer to
Dyax any Third Party agreements relating to the Development, Manufacture or
Commercialization of the Product to which Fovea is a party, to the extent that
such transfer is not expressly prohibited by the terms of such Third Party
agreements and (vii) Fovea shall (x) assign ownership of all Fovea Product
Intellectual Property that relates solely to the Product to Dyax, free and
clear of any liens or encumbrances and (y) grant Dyax a non-exclusive right and
license, with the right to grant sublicenses (subject to restrictions and
limitations similar to those set forth in Section 3.2(f) that are applicable to
sublicenses of licenses granted by Fovea to Dyax pursuant to Section 3.2
hereof), under all Fovea Product Intellectual Property to Develop, Manufacture
and Commercialize products containing the Compound inside and outside the Field
and throughout the world. The license granted pursuant to this Section 11.3(a) shall
be royalty-free, fully-paid and perpetual; provided, however, that
if and to the extent that any such license includes any sublicense of Third
Party intellectual property licensed by Fovea, then (1) such sublicense shall
be subject to the terms and conditions of the license between Fovea and such
Third Party and (2) Dyax shall be responsible for the payment to such Third
Party of any and all fees, payments and royalties due under the license between
Fovea and such Third Party as a result of the practice by Dyax 

 

* Confidential
Treatment Requested.  Omitted portions filed
with the Commission.

 

50

 

and its Related Parties and the Other Related Dyax Licensees of such
sublicensed Third Party intellectual property. Fovea shall execute all
documents and take all such further actions as may be reasonably requested by
Dyax in order to give effect to the foregoing clauses (i) through (vii).  Notwithstanding anything express or implied
in this Section 11.3(a) to the contrary, (x) any sublicense to a Third Party of
any of the rights licensed to Fovea pursuant to this Agreement that is in
effect at the time of the effective date of the termination of this Agreement
by Dyax in accordance with Sections 11.2(b) or (c) shall survive any such
termination of this Agreement and shall continue in full force and effect in
accordance with the respective terms thereof, provided that the terms of
such sublicense permit Dyax to replace Fovea as a party under such sublicense
upon any such termination of this Agreement and that such sublicense and its
terms conform with all of the requirements therefor set forth in this
Agreement, (y) Dyax’s rights under this Section 11.3(a) shall be subject to,
limited by, and may not be exercisable by virtue of, the terms of any
sublicense that survives, pursuant to the foregoing clause (x), such
termination of this Agreement, (z) no license is granted by Fovea under this Section
11.3(a) to use any compound, molecule, pharmaceutical composition or
development or product candidate developed without use of any Dyax Intellectual
Property and owned or Controlled by Fovea as an active pharmaceutical
ingredient in combination with the Compound unless such combination was the
form of the Product being Developed by Fovea pursuant to the Core Development
Plan.

 

(b)                                 Termination by Fovea for
Convenience. Without limiting any other legal or equitable
remedies that Dyax may have (but subject to the provisions set forth below in
this Section 11.3(b)), if Fovea terminates this Agreement in accordance with Section
11.2(a), then (i) if Fovea has exercised its termination right at any time
prior to [*****], Fovea shall
pay Dyax a one-time termination fee of [*****],
(ii) Fovea’s obligations under Section 10.1 shall survive for a period of one (1)
year after termination, (iii) the provisions of Section 11.3(a)(ii)-(v) shall
apply, and (iv) Fovea shall grant to Dyax (x) an exclusive right and license,
with the right to grant sublicenses (subject to restrictions and limitations
similar to those set forth in Section 3.2(f) that are applicable to sublicenses
of licenses granted by Fovea to Dyax pursuant to Section 3.2 hereof), under
Fovea Product Intellectual Property that relates solely to the Product, to
Develop, Manufacture and Commercialize the Product for the treatment of
indications that are inside and outside the Field and throughout the world and (y)
a non-exclusive right and license, with the right to grant sublicenses (subject
to restrictions and limitations similar to those set forth in Section 3.2(f) that
are applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section
3.2 hereof), under Fovea Product Intellectual Property to Develop, Manufacture
and Commercialize products containing the Compound inside and outside the Field
and throughout the world.  The licenses
granted pursuant to this Section 11.3(b) shall be royalty-free, fully-paid and
perpetual; provided, however, that
(1) if the effective date of termination occurs at any time after the
Regulatory Approval of the Product has been obtained in the Fovea Territory,
then Dyax will be obligated to pay Fovea royalties with respect to Net Sales in
the Fovea Territory and the Dyax Territory calculated pursuant to Section 7.1
at fifty percent (50%) of the royalty rates specified in Section 7.1(a)(ii),
but, in the case of Net Sales in the Dyax Territory, only if Regulatory
Approval of the Product in the Dyax Territory was materially based on data
generated by Fovea or its Related Parties in support of Regulatory Approval in
the Fovea Territory, and (2) if and to the extent that any such license
includes any sublicense of Third Party intellectual property licensed by Fovea,
then (A) such sublicense shall be subject to the terms and conditions of the
license between Fovea and such Third Party and (B) Dyax shall be responsible
for the payment to such Third Party of any and all fees, payments and royalties
due under the license between Fovea and such Third Party as a result of the
practice by Dyax and its Related Parties and the Other 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

51

 

Related Dyax Licensees of such sublicensed Third Party intellectual
property.  Fovea shall execute all
documents and take all such further actions as may be reasonably requested by
Dyax in order to give effect to the foregoing clauses (i) through (iv).  Notwithstanding anything express or implied
in this Section 11.3(b) to the contrary, no license is granted by Fovea under
this Section 11.3(b) to use any compound, molecule, pharmaceutical composition
or development or product candidate developed without use of any Dyax
Intellectual Property and owned or Controlled by Fovea as an active
pharmaceutical ingredient in combination with the Compound unless such combination
was the form of the Product being Developed by Fovea pursuant to the Core
Development Plan.

 

(c)                                  Termination by Fovea for
Cause.  Without limiting any other
legal or equitable remedies that Fovea may have, if Fovea terminates this
Agreement in accordance with Sections 11.2(b) or (c), (i) the provisions of Section
11.3(a)(ii)-(v) shall apply, and (ii) Fovea shall grant to Dyax a non-exclusive
right and license, with the right to grant sublicenses (subject to restrictions
and limitations similar to those set forth in Section 3.2(f) that are
applicable to sublicenses of licenses granted by Fovea to Dyax pursuant to Section
3.2 hereof), under Fovea Product Intellectual Property to Develop, Manufacture
and Commercialize products containing the Compound inside and outside the Field
and throughout the world. The license granted pursuant to this Section 11.3(c) shall
be royalty-free, fully-paid and perpetual; provided,
however, that (1) if the effective date of termination occurs at any
time prior to the Regulatory Approval of the Product has been obtained in the
Fovea Territory, then Dyax shall be obligated to pay Fovea [*****], (2) if the effective date of
termination occurs at any time after the Regulatory Approval of the Product has
been obtained in the Fovea Territory, then Dyax will be obligated to pay Fovea
royalties with respect to Net Sales in the Fovea Territory and the Dyax
Territory calculated pursuant to Section 7.1 at the royalty rates specified in Section
7.1(a)(ii), but, in the case of Net Sales in the Dyax Territory, only if
Regulatory Approval of the Product in the Dyax Territory was materially based
on data generated in support of Regulatory Approval in the Fovea Territory, and
(3) if and to the extent that any such license includes any sublicense of Third
Party intellectual property licensed by Fovea, then (A) such sublicense shall
be subject to the terms and conditions of the license between Fovea and such
Third Party and (B) Dyax shall be responsible for the payment to such Third
Party of any and all fees, payments and royalties due under the license between
Fovea and such Third Party as a result of the practice by Dyax and its Related
Parties and the Other Related Dyax Licensees of such sublicensed Third Party
intellectual property.  Fovea shall
execute all documents and take all such further actions as may be reasonably
requested by Dyax in order to give effect to the foregoing clauses (i) and
(ii).  Notwithstanding anything express
or implied in this Section 11.3(c) to the contrary, (x) any sublicense to a
Third Party of the rights licensed to Fovea pursuant to this Agreement that is
in effect at the time of the effective date of the termination of this
Agreement by Fovea in accordance with Sections 11.2(b) or (c) shall survive
such termination and shall continue in full force and effect in accordance with
the respective terms thereof, provided that the terms of such sublicense
permit Dyax to replace Fovea as a party under such sublicense upon any such
termination of this Agreement and that such sublicense and its terms conform
with all of the requirements therefor set forth in this Agreement, (y) Dyax’s
rights under this Section 11.3(c) shall be subject to, limited by, and may not
be exercisable by virtue of, the terms of any sublicense that survives,
pursuant to the foregoing clause (x), such termination of this Agreement, and (z)
no license is granted by Fovea under this Section 11.3(c) to use any compound,
molecule, pharmaceutical composition or development or product candidate
developed without use of any Dyax Intellectual Property and owned or Controlled
by Fovea as an active pharmaceutical ingredient in combination with the
Compound unless 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

52

 

such combination was the form of the Product being Developed by Fovea
pursuant to the Core Development Plan.

 

Section 11.4                                Survival.  In the event of any expiration or termination
of this Agreement, (a) all financial obligations under Article VII owed as of
the effective date of such expiration or termination shall remain in effect, (b)
all obligations to pay damages in connection with any material breach of this
Agreement that has not been cured or otherwise resolved or settled as of the
effective date of such expiration or termination shall remain in effect, and (c)
the provisions set forth in Article XIII and in Sections 7.4-7.9, 8.1, 8.2,
8.8(a), 9.1, 9.2, 10.1 (last sentence), 10.9 10.10, 10.11, 11.3, 11.4 and 12.3,
and all other provisions contained in this Agreement that by their terms
survive expiration or termination of this Agreement, shall survive.  In addition, in the event of an expiration of
this Agreement (but not in the event of any termination of this Agreement
pursuant to Section 11.2), the licenses granted in Sections 3.1 and 3.2 shall
survive as perpetual, fully paid-up, non-royalty-bearing licenses, and any
co-exclusive or exclusive license in such Sections shall convert to a
nonexclusive license.

 

ARTICLE XII

FINAL
DECISION-MAKING; DISPUTE RESOLUTION

 

Section 12.1                                Referral to
Executive Officers.  If for any
reason the JSC cannot resolve any matter properly referred to it, either Party
may refer the matter to the Executive Officers for resolution.  If after discussing the matter in good faith
and attempting to find a mutually satisfactory resolution to the issue, the
Executive Officers fail to come to consensus within [*****] after the date on which the matter is referred to the
Executive Officers, the provisions of Sections 12.2 and 12.3 shall apply and
resolutions reached through such provisions shall be binding on the Parties.

 

Section 12.2                                Final
Decision-Making Authority Allocated to a Single Party.  If the Executive Officers fail to come to
consensus on any matter referred to the Executive Officers within the period
for resolution set forth in Section 12.1, then

 

(a)                                  on matters
solely relating to the Development, Regulatory Approval, and Commercialization
of the Product in the Field in the Fovea Territory, including without
limitation the setting of the prices charged by Fovea and its Related Parties
for the Product in the Fovea Territory, Fovea shall have the final
decision-making authority;

 

(b)                                 on matters solely relating
to the Development, Regulatory Approval and Commercialization of the Product in
the Dyax Territory, including without limitation the setting of the prices
charged by Dyax and its Related Parties for the Product in the Dyax Territory,
or the selection of Global Trademarks, Dyax shall have the final
decision-making authority;

 

(c)                                  on matters
relating to the Manufacture of the Product, the Party with the applicable
Manufacturing responsibility under this Agreement shall have the final
decision-making authority;

 

(d)                                 on any matter that is
reasonably likely to materially and adversely impact (I) the Development,
Regulatory Approval or Commercialization of the Product in the Field in the
Dyax

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

53

 

 

Territory or (II) the Development, Regulatory Approval,
Manufacture or Commercialization of products containing the Compound in
indications outside the Field or within the Field (to the extent permitted
under this Agreement), Dyax shall have the final decision-making authority; provided, that if the Parties maintain
their good faith disagreement on whether such matter is reasonably likely to
cause or result in any such material and adverse impact, then either Party may
refer the matter to arbitration pursuant to Section 12.3 as modified by Exhibit D;
and, provided, further, that Dyax shall not exercise its
final decision-making authority over any matter under or subject to this Section 12.2(d) to:

 

(i)                                     require Fovea
to perform Development activities (including, without limitation, regulatory
activities) that Fovea is not otherwise required to conduct under this
Agreement; or

 

(ii)                                  increase the
budgeted Development Costs (including, without limitation, the costs of
regulatory activities) set forth in the Core Development Plan for any calendar
year, except that, in the case of the Development Costs of the Product for [*****], such Development Costs may
exceed the budgeted Development Costs set forth in the Core Development Plan by
[*****];

 

(e)                                  notwithstanding
the foregoing provisions of this Section 12.2, (I) neither Party
shall have final decision-making authority pursuant to this Section 12.2
with respect to (A) any decision by the JSC to treat any license entered
or to be entered into by a Party pursuant to Section 2.8 or Section 2.9
hereof as an In-License and (B) matters (i) over which one or the
other of the Parties is expressly allocated final decision-making authority
elsewhere in this Agreement, (ii) for which this Agreement expressly
provides that a decision shall not be made without the approval or consent of
one or both of the Parties, or (iii) relating to a breach or alleged
breach of this Agreement by a Party, and (II) neither Party may exercise
its final decision-making authority pursuant to this Section 12.2 so as to
change, modify or alter any express provision of this Agreement; and

 

(f)                                    with respect to
matters over which neither Party is allocated final-decision making authority
(other than matters for which this Agreement expressly provides that a decision
shall not be made without the approval or consent of one or both of the
Parties), the provisions of Section 12.3 shall apply.

 

Section 12.3                                Arbitration.  Any dispute arising out of or relating to
this Agreement that is not finally resolved through the provisions of Section 12.1
or 12.2, including without limitation the interpretation of this Agreement and
any breach or alleged breach of this Agreement, shall be resolved through
binding arbitration as follows; provided,
that specific matters for which this Agreement expressly provides that a
decision shall not be made without the approval or consent of one or both of
the Parties shall not be subject to resolution under this Section 12.3:

 

(a)                                  A Party may submit such
dispute to arbitration by notifying the other Party, in writing, of such
dispute.  Within [*****] after receipt of such notice, the Parties shall
designate in writing a single arbitrator to resolve the dispute; provided, however,
that if the Parties cannot agree on an arbitrator within such [*****]period, the arbitrator shall
be selected by the Boston, Massachusetts office of the American Arbitration
Association (the “AAA”).  The
arbitrator shall be a lawyer knowledgeable and experienced in the law
concerning the subject matter of the dispute, and shall not be an Affiliate, 

 

* Confidential Treatment
Requested.  Omitted portions filed with
the Commission.

 

54

 

employee, consultant, officer, director or stockholder of either Party
or of a Related Party of either Party or of an Other Related Dyax Licensee.

 

(b)                                 Within [*****] after the designation of the
arbitrator, the arbitrator and the Parties shall meet, at which time the
Parties shall be required to set forth in writing all disputed issues and a
proposed ruling on the merits of each such issue.

 

(c)                                  The arbitrator shall set a
date for a hearing, which shall be no later than forty-five (45) days after the
submission of written proposals pursuant to Section 12.3(b), to discuss
each of the issues identified by the Parties. 
The Parties shall have the right to be represented by counsel.  Except as provided herein, the arbitration
shall be governed by the Commercial Arbitration Rules of the AAA; provided, however,
that the Federal Rules of Evidence shall apply with regard to the
admissibility of evidence and the arbitration shall be conducted by a single
arbitrator.

 

(d)                                 The arbitrator shall use his
or her best efforts to rule on each disputed issue within [*****] after the completion of the
hearings described in this Section 12.3. 
The determination of the arbitrator as to the resolution of any dispute
shall be binding and conclusive upon all Parties.  All rulings of the arbitrator shall be in
writing and shall be delivered to the Parties.

 

(e)                                  The (i) attorneys’ fees
of the Parties in any arbitration, (ii) fees of the arbitrator and (iii) costs
and expenses of the arbitration shall be borne by the Parties as determined by
the arbitrator.

 

(f)                                    Any arbitration pursuant to
this Section 12.3 shall be conducted in Boston, Massachusetts.  Any arbitration award may be entered in and
enforced by a court in accordance with Section 13.7.

 

(g)                                 Nothing in this Section 12.3
shall be construed as limiting in any way the right of a Party to seek
injunctive relief with respect to any actual or threatened breach of this
Agreement from, or to bring an action in aid of arbitration in, a court in
accordance with Section 13.7. 
Should any Party seek injunctive relief, then for purposes of
determining whether to grant such injunctive relief, the dispute underlying the
request for such injunctive relief may be heard by a court in accordance with Section 13.7.

 

(h)                                 The arbitrator shall not
award damages excluded pursuant to Section 10.11.

 

ARTICLE XIII

MISCELLANEOUS

 

Section 13.1                                Choice of Law.  This Agreement shall be governed by and
interpreted under, and any court action in accordance with Section 13.7
shall apply, the laws of the Commonwealth of Massachusetts excluding: (a) its
conflicts of laws principles; (b) the United Nations Conventions on
Contracts for the International Sale of Goods; (c) the 1974 Convention on
the Limitation Period in the International Sale of Goods (the “1974
Convention”); and (d) the Protocol amending the 1974 Convention, done
at Vienna April 11, 1980.

 

* Confidential
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filed with the Commission.

 

55

 

Section 13.2                                Notices.  Any notice or report required or permitted to
be given or made under this Agreement by one of the Parties to the other shall
be in writing and shall be deemed to have been delivered upon personal delivery
or (a) four days after deposit in the mail or the business day next
following deposit with a reputable overnight courier and (b) in the case
of notices provided by facsimile (which notice shall be followed immediately by
an additional notice pursuant to clause (a) above if the notice is of a
default hereunder), upon completion of transmissions to the addressee’s
facsimile number, as follows (or at such other addresses or facsimile numbers
as may have been furnished in writing by one of the Parties to the other as
provided in this Section 13.2):

 

	
  If
  to Dyax:

  	
  Dyax
  Corp.

  
	
   

  	
  300
  Technology Square

  
	
   

  	
  Cambridge,
  Massachusetts 02139

  
	
   

  	
  U.S.A.

  
	
   

  	
   

  
	
   

  	
  [*****]

  
	
   

  	
   

  
	
  With
  a copy to:

  	
  Dyax
  Corp.

  
	
   

  	
  300
  Technology Square

  
	
   

  	
  Cambridge,
  Massachusetts 02139

  
	
   

  	
  U.S.A.

  
	
   

  	
   

  
	
   

  	
  [*****]

  
	
   

  	
   

  
	
  And
  to:

  	
  [*****]

  
	
   

  	
   

  
	
   

  	
  [*****]

  
	
   

  	
   

  
	
  If
  to Fovea:

  	
  Fovea Pharmaceuticals SA

  
	
   

  	
  12 rue Jean-Antoine de Baîf

  
	
   

  	
  75013 Paris, France  

  
	
   

  	
   

  
	
   

  	
  [*****]

  
	
   

  	
   

  
	
  With
  a copy to:

  	
  Fovea Pharmaceuticals SA

  
	
   

  	
  12 rue Jean-Antoine de Baîf

  
	
   

  	
  75013 Paris, France

  
	
   

  	
   

  
	
   

  	
  [*****]

  

 

Section 13.3                                Severability.  If, under applicable law or regulation, any
provision of this Agreement is invalid or unenforceable, or otherwise directly
or indirectly affects the validity of any other material provision(s) of
this Agreement (such invalid or unenforceable provision, a “Severed Clause”),
it is mutually agreed that this Agreement shall endure except for the Severed
Clause.  The Parties shall 

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

56

 

consult one another and use their
commercially reasonable efforts to agree upon a valid and enforceable provision
that is a reasonable substitute for the Severed Clause in view of the intent of
this Agreement.

 

Section 13.4                                Captions.  All captions herein are for convenience only
and shall not be interpreted as having any substantive meaning.

 

Section 13.5                                Integration.  This Agreement (together with all Exhibits),
the Supply Agreements and the safety data exchange procedures referred to in Section 4.5,
constitute the entire agreement between the Parties hereto with respect to the
within subject matter and supersedes all previous agreements, whether written
or oral, including but not limited to the Research and Option Agreement.  This Agreement may be amended only in writing
signed by properly authorized representatives of each of Dyax and Fovea.

 

Section 13.6                                Independent
Contractors; No Agency. 
Neither Party shall have any responsibility for the hiring, firing or
compensation of the other Party’s employees or for any employee benefits.  No employee or representative of a Party
shall have any authority to bind or obligate the other Party to this Agreement
for any sum or in any manner whatsoever, or to create or impose any contractual
or other liability on the other Party without said Party’s written
approval.  For all purposes, and
notwithstanding any other provision of this Agreement to the contrary, Fovea’s
legal relationship under this Agreement to Dyax shall be that of independent
contractor.

 

Section 13.7                                Submission to
Jurisdiction.  Each Party (a) submits
to the exclusive jurisdiction of the state and federal courts sitting in
Boston, Massachusetts, with respect to actions or proceedings arising out of or
relating to this Agreement in which a Party brings an action in aid of
arbitration, (b) agrees that all claims in respect of such action or
proceeding may be heard and determined only in any such court, and (c) agrees
not to bring any action or proceeding arising out of or relating to this
Agreement in any other court, other than an action or proceeding seeking
injunctive relief or brought to enforce an arbitration ruling issued pursuant
to Section 12.3.  Each Party waives
any defense of inconvenient forum to the maintenance of any action or
proceeding so brought and waives any bond, surety or other security that might
be required of the other Party with respect thereto.  Each Party may make service on the other
Party by sending or delivering a copy of the process to the Party to be served
at the address and in the manner provided for the giving of notices in Section 13.2.  Nothing in this Section 13.7, however, shall
affect the right of any Party to serve legal process in any other manner
permitted by law.

 

Section 13.8                                Assignment;
Successors.  Neither
Dyax nor Fovea may assign this Agreement in whole or in part, nor any rights
hereunder, without the prior written consent of the other Party; provided that (a) either Party may
assign this Agreement to an Affiliate, (b) this Agreement may be assigned
by Fovea to a Third Party that is not a Product Competitor (defined below) in
connection with a sale or transfer of all or substantially all of Fovea’s
business or assets to which this Agreement relates, and (c) this Agreement
may be assigned by Dyax to a Third Party in connection with a sale or transfer
of all or substantially all of Dyax’s business or assets to which this
Agreement relates. A “Product Competitor” shall mean any Person (x) that
is pursuing clinical Development or Commercialization of a Competing Product
for the treatment of any ophthalmic indication in humans in the Fovea Territory
if and to the extent that the Product either is in clinical Development
pursuant to the Core Development Plan for the 

 

* Confidential
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filed with the Commission.

 

57

 

treatment of such ophthalmic indication or
has received Regulatory Approval and is being Commercialized in the Fovea
Territory for the treatment of such ophthalmic indication or (y) that is
pursuing clinical Development or Commercialization of a Competing Product for
the treatment of any ophthalmic indication in humans in the United States if
and to the extent that the Product either is in clinical Development pursuant
to the Supplemental Development Plan for the treatment of such ophthalmic
indication in the United States or has received Regulatory Approval and is
being Commercialized in the United States for the treatment of such ophthalmic
indication.  Exhibit F sets
forth a list of Third Parties that, as of the Effective Date, meet the
definition of Product Competitor.  Exhibit F
may be amended from time to time by written notice of Dyax to Fovea to add
and/or delete the names of Third Parties that meet or no longer meet, as
applicable, the definition of Product Competitor. As a condition to any such
assignment otherwise permitted pursuant to the foregoing provisions of this Section 13.8,
the assignee shall agree in writing to assume and perform all of the
obligations of the assigning Party under this Agreement, and the assigning
Party shall remain primarily liable under this Agreement for the prompt and
punctual payment and performance of all obligations of the assignee.  Any assignment made other than in accordance
with the immediately preceding sentence shall be wholly void and invalid, and
the assignee in any such assignment shall acquire no rights whatsoever, and the
non-assigning Party shall not recognize, nor shall it be required to recognize,
such assignment.  This Section 13.8
limits both the right and the power to assign this Agreement and/or rights
under this Agreement.  This Agreement
shall be binding upon, and shall inure to the benefit of, all permitted
successors and assigns.

 

Section 13.9                                Execution in
Counterparts; Facsimile Signatures.  This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument even if both Parties have not
executed the same counterpart. 
Signatures provided by facsimile transmission shall be deemed to be
original signatures.

 

Section 13.10                          Waiver.  The waiver by either Party hereto of any
right hereunder, or of the failure of the other Party to perform, or of a
breach by the other Party, shall not be deemed a waiver of any other right
hereunder or of any other breach or failure by such other Party whether of a
similar nature or otherwise

 

Section 13.11                          Performance by
Affiliates.  To the
extent that this Agreement imposes obligations on Affiliates of a Party, such
Party agrees to cause its Affiliates to perform such obligations

 

Section 13.12                          Force Majeure.  Neither Party shall be held liable to the
other Party nor be deemed to have defaulted under or breached the Agreement for
failure or delay in performing any obligation under 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, embargoes, war,
acts of war (whether war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, fire, floods, or other acts of
God, or acts, omissions or delays in acting by any governmental authority or
the other Party.  The affected Party
shall notify the other Party of such force majeure circumstances as soon as
reasonably practical, and shall promptly undertake all reasonable efforts
necessary to cure such force majeure circumstances.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

58

 

Section 13.13                          Further
Assurances.  Each Party
agrees to do and perform all such further acts and things and shall execute and
deliver such other agreements, certificates, instruments and documents
necessary or that the other Party may deem advisable in order to carry out the
intent and accomplish the purposes of this Agreement and to evidence, perfect
or otherwise confirm its rights hereunder.

 

* Confidential
Treatment Requested.  Omitted portions
filed with the Commission.

 

59

 

IN WITNESS WHEREOF, Dyax and Fovea have
caused this Agreement to be duly executed by their authorized representatives
under seal, effective as of the date first above written.

 

	
   

  	
  DYAX CORP.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Gustav Christensen

  
	
   

  	
   

  	
  Name: Gustav Christensen

  
	
   

  	
   

  	
  Title: EVP & CBO

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  FOVEA PHARMACEUTICALS SA

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Bernard Gilly

  
	
   

  	
   

  	
  Name: Bernard Gilly

  
	
   

  	
   

  	
  Title: Chairman &
  Chief Operating Officer

  

 

* Confidential
Treatment Requested.  Omitted portions filed
with the Commission.

 

60

 

EXHIBIT A

 

Amino Acid Sequence of DX-88

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

A-1

 

EXHIBIT B

 

Development Plan

 

[*****]

 

B-1

 

EXHIBIT C-1

 

Existing Dyax Patent Rights

 

	
  MATTER

  	
   

  	
  SERIAL

  	
   

  	
  PATENT

  	
   

  	
  PUBL

  	
   

  	
  TITLE

  	
   

  	
  STATUS

  	
   

  	
  ISSUE

  
	
  10280-096AT1

  	
   

  	
  95909223.0

  	
   

  	
  E
  275 583

  	
   

  	
  739355

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096BE1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096CA1

  	
   

  	
  2180950

  	
   

  	
  2180950

  	
   

  	
   

  	
   

  	
  KALLIKREIN-INHIBITING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  3
  /29/2005

  
	
  10280-096CH1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096DE1

  	
   

  	
  95909223.0

  	
   

  	
  69533472.7

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096DK1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
  739355

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096EP1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
  EP0739355

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096EP2

  	
   

  	
  04019920.0

  	
   

  	
   

  	
   

  	
  EP1484339

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  PUBLISHED

  	
   

  	
   

  
	
  10280-096ES1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096FR1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096GB1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096GR1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096HK2

  	
   

  	
  05104679.5

  	
   

  	
   

  	
   

  	
  1071899A

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  PUBLISHED

  	
   

  	
   

  

 

C-1

 

	
  MATTER

  	
   

  	
  SERIAL

  	
   

  	
  PATENT

  	
   

  	
  PUBL

  	
   

  	
  TITLE

  	
   

  	
  STATUS

  	
   

  	
  ISSUE

  
	
  10280-096IE1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096IT1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
  WO95/21601

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096JP1

  	
   

  	
  7-518726

  	
   

  	
  3805785

  	
   

  	
  9511131

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  5
  /19/2006

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  
	
  10280-096LU1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096MC1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096NL1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096PT1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
  739355

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096SE1

  	
   

  	
  95909223.0

  	
   

  	
  0739355

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  9
  /8 /2004

  
	
  10280-096US1

  	
   

  	
  08/676,125

  	
   

  	
  5,795,865

  	
   

  	
   

  	
   

  	
  KALLIKREIN-INHIBITING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  8
  /18/1998

  
	
  10280-096001

  	
   

  	
  08/208,264

  	
   

  	
  6,057,287

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  5
  /2 /2000

  
	
  10280-096002

  	
   

  	
  09/421,097

  	
   

  	
  6,333,402

  	
   

  	
   

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEROF

  	
   

  	
  ISSUED

  	
   

  	
  12/25/2001

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  
	
  10280-096004

  	
   

  	
  09/136,012

  	
   

  	
  5,994,125

  	
   

  	
   

  	
   

  	
  KALLIKREIN-INHIBITING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  ISSUED

  	
   

  	
  11/30/1999

  
	
  10280-096005

  	
   

  	
  11/365,438

  	
   

  	
   

  	
   

  	
  US
  2006-

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ 

  	
   

  	
  PUBLISHED

  	
   

  	
   

  

 

C-2

 

	
  MATTER

  	
   

  	
  SERIAL

  	
   

  	
  PATENT

  	
   

  	
  PUBL

  	
   

  	
  TITLE

  	
   

  	
  STATUS

  	
   

  	
  ISSUE

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0264603
  A1

  	
   

  	
  DOMAIN”
  PROTEINS AND ANALOGUES THEREOF

  	
   

  	
   

  	
   

  	
   

  
	
  10280-096WO1

  	
   

  	
  PCT/US95/00299

  	
   

  	
   

  	
   

  	
  WO95/21601

  	
   

  	
  KALLIKREIN-BINDING
  “KUNITZ DOMAIN” PROTEINS AND ANALOGUES THEREOF

  	
   

  	
  PUBLISHED

  	
   

  	
   

  
	
  10280-094003

  	
   

  	
  11/323,261

  	
   

  	
  7,276,480

  	
   

  	
  US
  2007-0249807 A1

  	
   

  	
  PREVENTION
  AND REDUCTION OF BLOOD LOSS

  	
   

  	
  ISSUED

  	
   

  	
  10/2
  /2007

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  
	
  10280-143001

  	
   

  	
  11/716,278

  	
   

  	
   

  	
   

  	
  US
  2007-0213275 A1

  	
   

  	
  FORMULATIONS
  FOR ECALLANTIDE

  	
   

  	
  PUBLISHED

  	
   

  	
   

  
	
  10280-143WO1

  	
   

  	
  PCT/US07/63703

  	
   

  	
   

  	
   

  	
  WO2007106746
  A2

  	
   

  	
  FORMULATIONS
  FOR ECALLANTIDE

  	
   

  	
  PUBLISHED

  	
   

  	
   

  

 

C-3

 

EXHIBIT C-2

 

Fovea —Assigned Dyax Patent Rights

 

	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  
	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*****]

  	
   

  	
  [*****]

  	
   

  	
   

  

 

C-4

 

EXHIBIT C-3

 

[*****]
Patent Rights

 

[*****]

 

C-5

 

EXHIBIT D

 

Arbitration Procedures for Certain Collaboration
Governance Issues

 

1.  General.  In the event that the JSC is unable to reach
consensus on a decision-making matter other than (a) a matter with respect
to which one of the Parties is expressly allocated decision-making authority in
this Agreement or (b) a matter for which this Agreement expressly provides
that a decision shall not be made without the approval or consent of one or
both of the Parties, the decision shall be made through binding arbitration in
accordance with the provisions of Article XII as modified by this Exhibit D.

 

2.  Designation
of Arbitrator.  In the event of any
dispute subject to this Exhibit D, the Parties shall designate an
arbitrator in accordance with Section 12.3(a); provided that (a) the Parties shall make such
designation (or referral to the AAA) within [*****] and (b) the arbitrator shall be a former pharmaceutical
or biotechnology industry executive with experience in the subject matter of
the dispute.

 

3.  Exchange
of Proposed Resolutions; Advocacy. 
Within [*****] after the
designation of the arbitrator, the Parties shall exchange their proposed resolutions
of the dispute together with a brief or other written memorandum supporting the
merits of their final proposed resolutions. 
The arbitrator and the Parties shall then meet within [*****], at which time each Party
shall have one hour to argue in support of its final proposed resolution.  The provisions of the foregoing sentence may
be modified at the discretion of the arbitrator.  The Parties shall not call any witnesses in support
of their arguments unless the arbitrator otherwise determines in his or her
discretion.

 

4.  Selection
of Proposed Resolution.  The
arbitrator shall select as the binding resolution the proposed resolution that
reflects the more commercially reasonable resolution consistent with the goals
and obligations of the Parties set forth in the Agreement within [*****] (or such longer period of
time as the arbitrator determines in his or her discretion) after the meeting
with the arbitrator referred to in the immediately preceding paragraph.

 

D-1

 

EXHIBIT E

 

Dyax Supply Agreement Terms

 

1.             The
provisions set forth in this Exhibit E shall apply to the obligation of
Dyax to supply API Bulk Drug Substance to Fovea for use in the Manufacture and
supply by Fovea of Finished Product for commercial sale in the Fovea Territory
by Fovea and its Related Parties and for commercial sale in the Dyax Territory
by Dyax and its Related Parties.

 

2.             Dyax
and Fovea shall mutually agree upon the specifications, including the necessary
documentation, certificates of analysis and test results, for the API Bulk Drug
Substance to be supplied under the Dyax Supply Agreement (the “Specifications”).  Fovea shall use the API Bulk Drug Substance
supplied by Dyax solely for such purposes permitted under this Agreement and
shall not transfer any such API Bulk Drug Substance to any Third Party for any
other purpose.

 

3.             Unless
agreed otherwise in writing by the Parties or as otherwise set forth in the
Dyax Supply Agreement, [*****] before the commencement of each
calendar quarter, Fovea will give to Dyax a forecast of Fovea’s estimated
quarterly requirements of API Bulk Drug Substance for the [*****] commencing
with such calendar quarter.  Such
forecast will include quantity and unit requirements for API Bulk Drug Substance
on a country-by-country basis.  [*****] of Fovea’s forecasted requirements of API Bulk Drug Substance
during the [*****] of such forecast, and [*****] of Fovea’s forecasted requirements of API Bulk Drug Substance
during the [*****] of such forecast, shall be
considered binding.  Fovea’s forecasted
requirements of API Bulk Drug Substance during the last four quarters of such
forecast will be non-binding. Fovea will provide Dyax with binding purchase
orders for API Bulk Drug Substance at least [*****] in
advance of the delivery date for such API Bulk Drug Substance.  The Parties agree that they will revisit the
provisions of this paragraph 3 at the time of the negotiation of the Dyax
Supply Agreement to ensure that they are appropriate considering the interests
of both Parties.

 

4.             In
the event of a shortage of supply of API Bulk Drug Substance, Dyax shall
promptly notify Fovea and, unless otherwise agreed by the Parties, (a) prior
to such time as Dyax (whether directly or through a Related Party) and Fovea
(whether directly or through a Related Party) shall have each been selling
Product for a period of [*****],
available supply shall be allocated between the respective Parties on a
pro-rata basis based on good faith forecasts of requirements and (b) once Dyax
(whether directly or through a Related Party) and Fovea (whether directly or
through a Related Party) shall have been selling Product for a period [*****], available supply shall
be allocated between the respective Parties on a pro-rata basis based on
quantities purchased during the prior [*****].  In addition, Dyax will use Diligent Efforts
to resolve all failure to supply issues as promptly as possible in consultation
with Fovea.

 

5.             Dyax
agrees that all API Bulk Drug Substance supplied to Fovea will, at the time of
delivery to Fovea, have been Manufactured in accordance with the
Specifications.

 

6.             In
addition to more detailed terms regarding the matters specified above in this Exhibit E,
the Dyax Supply Agreement shall contain other customary supply agreement
provisions.

 

E-1

 

EXHIBIT F

 

Product Competitors

 

[*****]

 

F-1

 

EXHIBIT G

 

[*****]
Payments

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

 

[*****]

 

[*****]

 

[*****]

 

[*****]

 

G-1

 

EXHIBIT H

 

Non-European Union Countries within the Fovea
Territory

 

Russia

 

Turkey

 

Switzerland

 

H-1

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