SHALL MEAN, WITH
RESPECT TO THE PRODUCT, THE CARRYING OUT OF OBLIGATIONS IN A COMMERCIALLY
REASONABLE, DILIGENT AND SUSTAINED MANNER USING EFFORTS NOT LESS THAN THE
EFFORTS A PARTY DEVOTES TO A PRODUCT OF SIMILAR MARKET POTENTIAL, PROFIT
POTENTIAL OR STRATEGIC VALUE, AT A SIMILAR STAGE OF ITS PRODUCT LIFE AND BASED
ON CONDITIONS THEN PREVAILING, BUT EXCLUDING CONSIDERATION OF ANY OBLIGATION TO
THE OTHER PARTY UNDER THIS AGREEMENT.
SECTION 1.13
"DISTRIBUTOR".
DISTRIBUTOR SHALL MEAN, WITH RESPECT TO A
PARTY, A THIRD PARTY DISTRIBUTOR OF SUCH PARTY WITH RESPECT TO THE PRODUCT THAT
IS NOT A RELATED PARTY OF SUCH PARTY.
SECTION 1.14
"DYAX INTELLECTUAL PROPERTY".
DYAX INTELLECTUAL PROPERTY
SHALL MEAN DYAX KNOW-HOW AND DYAX PATENT RIGHTS, COLLECTIVELY.
SECTION 1.15
"DYAX KNOW-HOW".
DYAX KNOW-HOW SHALL MEAN ANY KNOW-HOW
THAT (A) [*****] IS CONTROLLED BY DYAX ON THE EFFECTIVE DATE [*****] AND (B) IS
[*****] FOR THE DEVELOPMENT, MANUFACTURE AND/OR COMMERCIALIZATION OF THE PRODUCT
IN THE FIELD AS CONTEMPLATED BY THIS AGREEMENT.
SECTION 1.16
"DYAX PATENT RIGHTS".
DYAX PATENT RIGHTS SHALL MEAN
PATENT RIGHTS, INCLUDING DYAX'S RIGHTS IN JOINT PATENT RIGHTS, THAT (A) COVER
DYAX KNOW-HOW AND (B) ARE CONTROLLED BY DYAX ON THE EFFECTIVE DATE OR COME
WITHIN DYAX'S CONTROL DURING THE TERM, INCLUDING WITHOUT LIMITATION, THE
EXISTING DYAX PATENT RIGHTS AND THE FOVEA-ASSIGNED PATENT RIGHTS.
SECTION 1.17
"DYAX TERRITORY".
DYAX TERRITORY SHALL MEAN ALL
COUNTRIES OF THE WORLD OTHER THAN THE FOVEA TERRITORY.
SECTION 1.18
"EMEA".
EMEA SHALL MEAN THE EUROPEAN MEDICINES AGENCY OR
ANY SUCCESSOR AGENCY THERETO.
SECTION 1.19
"EUROPEAN UNION" OR "EU".
EUROPEAN UNION OR EU SHALL
MEAN THE COUNTRIES OF THE EUROPEAN UNION, AS IT IS CONSTITUTED AS OF THE
EFFECTIVE DATE AND AS IT MAY BE EXPANDED FROM TIME TO TIME.
SECTION 1.20
"EXECUTIVE OFFICERS".
EXECUTIVE OFFICERS SHALL MEAN THE
CHIEF EXECUTIVE OFFICER OF DYAX (OR A SENIOR EXECUTIVE OFFICER OF DYAX
DESIGNATED BY DYAX'S CHIEF EXECUTIVE OFFICER) AND THE CHIEF EXECUTIVE OFFICER OF
FOVEA (OR A SENIOR EXECUTIVE OFFICER OF FOVEA DESIGNATED BY FOVEA'S CHIEF
EXECUTIVE OFFICER).
* Confidential Treatment Requested.
Omitted portions filed with the Commission.
3
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