Exhibit 10.19

 

LICENSE AGREEMENT

 

BY AND BETWEEN

 

DYAX CORP.

 

AND

 

FOVEA PHARMACEUTICALS SA

 

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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,

 

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

 

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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

 

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

 

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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).

 

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* 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.

 

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

 

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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.

 

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

 

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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

 

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

 

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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.

 

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

 

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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

 

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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

 

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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)

 

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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

 

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(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.

 

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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.

 

[*****]

 

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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.

 

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(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

 

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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

 

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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,

 

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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

 

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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

 

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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.

 

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(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

 

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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

 

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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

 

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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

 

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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

 

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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

 

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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

 

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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

 

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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

 

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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 $[*****]

 

[*****]

%

 

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; 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

 

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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

 

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(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.

 

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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.

 

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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

 

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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

 

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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

 

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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,

 

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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

 

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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:

 

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(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

 

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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

 

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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

 

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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

 

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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,

 

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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.

 

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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

 

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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 Treatment Requested.  Omitted portions 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

--------------------------------------------------------------------------------