SUCH THIRD PARTY TO INOVIO THAT COMPRISES INOVIO LICENSED TECHNOLOGY.
1.22.
KNOW-HOW.
"KNOW-HOW" SHALL MEAN ANY CONFIDENTIAL UNPATENTED
OR UNPATENTABLE TECHNOLOGY, COMPOUND, CELL LINE OR OTHER BIOLOGICAL MATERIAL,
PROBE, SEQUENCE, TECHNICAL INFORMATION, METHOD, OR OTHER CONFIDENTIAL
INFORMATION OR MATERIAL, IN ALL CASES TO THE EXTENT, BUT ONLY TO THE EXTENT, NOT
IN THE PUBLIC DOMAIN AND NECESSARY FOR THE COMMERCIALIZATION OF THE LICENSED
PRODUCT IN THE FIELD.
1.23.
LICENSED FIELD.
"LICENSED FIELD" SHALL MEAN THE ABLATION
TREATMENT OF ALL HUMAN SOLID TUMORS BY MEANS OF EP, USING EITHER BLEOMYCIN® OR
THE ADDITIONAL AGENT.
1.24.
LICENSED PRODUCT.
"LICENSED PRODUCT" SHALL MEAN ANY PRODUCT
THAT USES BLEOMYCIN® OR THE ADDITIONAL AGENT WITH THE DEVICE TO TREAT PATIENTS
IN THE LICENSED FIELD.
1.25.
MANUFACTURE.
"MANUFACTURE," "MANUFACTURED" OR "MANUFACTURING"
MEANS ALL ACTIVITIES INVOLVED IN THE PRODUCTION, PACKAGING AND LABELING OF A
LICENSED PRODUCT TO BE COMMERCIALIZED UNDER THIS AGREEMENT.
1.26.
PATENT RIGHTS.
"PATENT RIGHTS" SHALL MEAN ANY AND ALL (A)
U.S. OR FOREIGN PATENTS, (B) U.S. OR FOREIGN PATENT APPLICATIONS, INCLUDING,
WITHOUT LIMITATION, ALL PROVISIONAL APPLICATIONS, SUBSTITUTIONS, CONTINUATIONS,
CONTINUATIONS-IN-PART, DIVISIONS, RENEWALS, AND ALL PATENTS GRANTED THEREON, (C)
ALL U.S. OR FOREIGN PATENTS-OF-ADDITION, REISSUES, REEXAMINATIONS AND EXTENSIONS
OR RESTORATIONS BY EXISTING OR FUTURE EXTENSION OR RESTORATION MECHANISMS,
INCLUDING, WITHOUT LIMITATION, PATENT TERM ADJUSTMENTS, PATENT TERM EXTENSIONS,
SUPPLEMENTARY PROTECTION CERTIFICATES OR THE EQUIVALENT THEREOF, AND (D) ANY
OTHER FORM OF GOVERNMENT-ISSUED RIGHT SUBSTANTIALLY SIMILAR TO ANY OF THE
FOREGOING.
1.27.
PERSON.
"PERSON" SHALL MEAN ANY INDIVIDUAL OR LEGAL ENTITY.
1.28.
PRODUCT DATA.
"PRODUCT DATA" SHALL MEAN ALL PRE-CLINICAL DATA
AND RESULTS, CLINICAL PROTOCOLS, STUDIES, CLINICAL DATA AND RESULTS,
POST-MARKETING DATA AND RESULTS, MANUFACTURING DATA AND RESULTS, AND OTHER
INFORMATION NECESSARY OR USEFUL FOR OBTAINING REGULATORY APPROVAL OF A LICENSED
PRODUCT IN THE LICENSED FIELD.
4
1.29.
PROMOTION.
"PROMOTION" SHALL MEAN THOSE ACTIVITIES NORMALLY
UNDERTAKEN BY A PHARMACEUTICAL COMPANY'S SALES FORCE TO IMPLEMENT MARKETING
PLANS AND STRATEGIES AIMED AT ENCOURAGING THE APPROVED USE OF A PARTICULAR
LICENSED PRODUCT.
WHEN USED AS A VERB, "PROMOTE" MEANS TO ENGAGE IN SUCH
ACTIVITIES.
1.30.
RECALL.
"RECALL" SHALL MEAN, WITH RESPECT TO ANY
PHARMACEUTICAL PRODUCT, A "RECALL" OR A "PRODUCT WITHDRAWAL" OR A "STOCK
RECOVERY" OR ANY SIMILAR TERM AS UTILIZED BY ANY REGULATORY AUTHORITY UNDER SUCH
REGULATORY AUTHORITY'S PROCEDURES REGARDING THE RECALL OF PHARMACEUTICAL
PRODUCTS, AS THE SAME MAY BE AMENDED FROM TIME TO TIME, AND SHALL INCLUDE ANY
POST-SALE WARNING OR MAILING OF INFORMATION REGARDING SUCH PRODUCT, INCLUDING
ANY WARNINGS OR MAILINGS DESCRIBED IN THE REGULATORY AUTHORITY'S PRODUCT RECALL
PROCEDURES.
1.31.
REGULATORY APPROVAL.
"REGULATORY APPROVAL" MEANS ANY
TECHNICAL, MEDICAL, SCIENTIFIC OR OTHER LICENSE, REGISTRATION, AUTHORIZATION OR
APPROVAL OF ANY REGULATORY AUTHORITY REGARDING THE RESEARCH, DEVELOPMENT,
CLINICAL TESTING, COMMERCIAL MANUFACTURE, DISTRIBUTION, MARKETING, PRICING,
REIMBURSEMENT, PROMOTION, OFFER FOR SALE, USE, IMPORT, EXPORT OR SALE OF ANY
PHARMACEUTICAL PRODUCT, PROPOSED PHARMACEUTICAL PRODUCT, MEDICAL DEVICE,
PROPOSED MEDICAL DEVICE, OR ANY COMBINATION THEREOF.
1.32.
REGULATORY AUTHORITY.
"REGULATORY AUTHORITY" SHALL MEAN, WITH
RESPECT TO A COUNTRY IN THE TERRITORY, ANY NATIONAL, SUPRA-NATIONAL, REGIONAL,
STATE OR LOCAL REGULATORY AGENCY, DEPARTMENT, BUREAU, COMMISSION, COUNCIL OR
OTHER