DISTRIBUTION AND SALE OF A PRODUCT, AND THE
PROCESS OF COMMERCIALIZATION, RESPECTIVELY.
1.11
"CONFIDENTIAL INFORMATION" SHALL HAVE THE MEANING
ASSIGNED TO IT IN SECTION 20.1.
1.12
"CONTROL" OR "CONTROLLED" SHALL MEAN POSSESSION
OF THE ABILITY TO GRANT A LICENSE OR SUBLICENSE OF PATENT RIGHTS, KNOW-HOW,
TECHNICAL INFORMATION OR OTHER INTANGIBLE RIGHTS AS PROVIDED FOR HEREIN WITHOUT
VIOLATING THE TERMS OF ANY AGREEMENT OR OTHER ARRANGEMENT WITH ANY THIRD PARTY.
1.13
"DEVICE" SHALL MEAN, INDIVIDUALLY OR
COLLECTIVELY, AS THE CASE MAY BE, THE ELECTROPORATION GENERATOR USED FOR THE
ELECTRICALLY ASSISTED DELIVERY OF PRODUCTS AND/OR THE DISPOSABLE APPLICATOR.
1.14
"DISEASE CLASS" MEANS A DISEASE CATEGORY BEING
THE SUBJECT OF A SEPARATE SECTION OF THE MERCK MANUAL OF DIAGNOSIS AND THERAPY,
17TH EDITION, 1999.
1.15
"DRUG APPROVAL APPLICATION" MEANS AN APPLICATION
FOR REGULATORY APPROVAL REQUIRED TO BE APPROVED BEFORE COMMERCIAL SALE OR USE OF
A PRODUCT AS A DRUG IN A REGULATORY JURISDICTION, INCLUDING, FOR PURPOSES OF
REGULATORY APPROVAL IN THE US, A NEW DRUG APPLICATION OR A BIOLOGICAL LICENSE
APPLICATION AND ALL SUPPLEMENTS FILED PURSUANT TO THE REQUIREMENTS OF THE FDA
(INCLUDING ALL DOCUMENTS, DATA AND OTHER INFORMATION CONCERNING A PRODUCT THAT
ARE NECESSARY FOR, OR INCLUDED IN, FDA APPROVAL TO MARKET A PRODUCT) AND,
7
FOR THE PURPOSES OF REGULATORY APPROVAL IN THE EU, ALL APPLICATIONS FOR
REGULATORY APPROVAL TO EMEA OR ANY OTHER APPLICABLE NATIONAL REGULATORY
AUTHORITY.
1.16
"EFFECTIVE DATE" SHALL HAVE THE MEANING SET FORTH
AT THE HEAD OF THIS AGREEMENT.
1.17
"ELECTROPORATION" MEANS A CERTAIN DELIVERY
TECHNOLOGY LICENSED BY VALENTIS FROM GENETRONICS, INC., RELATING TO
ELECTRICALLY-ASSISTED PLASMID DELIVERY TO MUSCLE FOR THERAPEUTIC OR PROPHYLACTIC
APPLICATIONS, EXCLUDING DNA VACCINES.
1.18
"ELECTROPORATION INTELLECTUAL PROPERTY" MEANS
ELECTROPORATION KNOW-HOW AND ELECTROPORATION PATENTS.
1.19
"ELECTROPORATION KNOW-HOW" MEANS ALL INFORMATION
CURRENTLY EXISTING, WHETHER OR NOT PATENTABLE, THAT IS CONTROLLED BY VALENTIS OR
ITS AFFILIATES AND THAT RELATES TO ELECTROPORATION, AND IMPROVEMENTS TO
ELECTROPORATION COMING WITHIN THE OWNERSHIP OR CONTROL OF VALENTIS OR ITS
AFFILIATES DURING THE TERM OF THIS AGREEMENT.
1.20
"ELECTROPORATION PATENTS" MEANS ANY PATENTS
RELATING TO ELECTROPORATION, OWNED OR CONTROLLED BY VALENTIS OR ITS AFFILIATES.
A LIST OF ELECTROPORATION PATENTS EXISTING AS OF THE EFFECTIVE DATE IS ATTACHED
HERETO AS APPENDIX 1.20.
"ELECTROPORATION PATENTS" SHALL ALSO INCLUDE ANY
PATENT ON ANY IMPROVEMENT TO ELECTROPORATION COMING WITHIN THE OWNERSHIP OR
CONTROL OF VALENTIS DURING THE TERM OF THIS AGREEMENT.
1.21
"EMEA" MEANS THE EUROPEAN MEDICINES EVALUATION
AGENCY, OR ANY SUCCESSOR AGENCY.
1.22
"EU" MEANS THE COUNTRIES OF THE EUROPEAN UNION,
AT ANY GIVEN POINT IN TIME.
1.23
"FDA" MEANS THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, OR ANY SUCCESSOR
AGENCY WITH RESPONSIBILITY FOR REGULATING THE DEVELOPMENT, MANUFACTURE AND SALE
OF HUMAN PHARMACEUTICAL PRODUCTS.
1.24
"FIELD" MEANS ALL PREVENTIVE, THERAPEUTIC OR
DIAGNOSTIC APPLICATIONS IN HUMANS.
1.25
"FIRST COMMERCIAL SALE" MEANS THE DATE SCHERING
OR AN AFFILIATE OR A SUBLICENSEE OF SCHERING FIRST SELLS COMMERCIALLY, PURSUANT
TO A REGULATORY APPROVAL, A PRODUCT TO A THIRD PARTY IN ANY COUNTRY OF THE
TERRITORY.
A SALE OF A