CLINICAL TRIALS SHALL INCLUDE, WITHOUT LIMITATION, STUDIES RELATED TO THE
PRODUCT THAT ARE SPONSORED BY A THIRD PARTY BUT SUPPORTED BY A PARTY (EITHER
THROUGH FINANCIAL SUPPORT OR THROUGH THE PROVISION OF STUDY DRUGS). PHASE IV
CLINICAL TRIALS MAY ALSO INCLUDE A HUMAN CLINICAL TRIAL OF THE PRODUCT THAT IS
REQUIRED BY THE REGULATORY AUTHORITY IN A COUNTRY TO BE CONDUCTED FOLLOWING
REGULATORY APPROVAL OF THE PRODUCT IN THAT COUNTRY, AS AN EXPLICIT CONDITION OF
THAT REGULATORY APPROVAL.
1.93
"PHILANTHROPIC FUNDS" SHALL HAVE THE MEANING SET FORTH IN ARTICLE 6.
1.94
"PIVOTAL CLINICAL TRIAL" MEANS A PHASE III CLINICAL TRIAL OR, UNDER THE
FOLLOWING CIRCUMSTANCES, A PHASE II CLINICAL TRIAL. A PHASE II CLINICAL TRIAL
SHALL BE CONSIDERED A PIVOTAL CLINICAL TRIAL IF AND WHEN (A) IN THE UNITED
STATES, THE PROTOCOL FOR THAT PHASE II CLINICAL TRIAL SHALL HAVE BEEN REVIEWED
BY THE FDA UNDER ITS CURRENT SPECIAL PROTOCOL ASSESSMENT GUIDELINES (OR
EQUIVALENT GUIDELINES ISSUED IN THE FUTURE), AND ANY COMMENTS FROM THE FDA ON
THAT PROTOCOL ARE INCORPORATED IN THE FINAL PROTOCOL FOR THAT PHASE II
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
10
CLINICAL TRIAL OR ARE RESOLVED TO THE FDA'S SATISFACTION AS EVIDENCED BY FURTHER
WRITTEN COMMUNICATIONS FROM THE FDA; [***]
1.95
"PRIMARY DETAIL" MEANS A SALES CALL FOR THE PRODUCT IN WHICH THE
PRODUCT RECEIVES THE PREDOMINANT PORTION OF EMPHASIS AND TIME DURING THE SALES
CALL (I.E., NO OTHER PRODUCT OR SERVICE RECEIVES MORE EMPHASIS OR TIME DURING
THE SALES CALL, WHERE SUCH CALCULATION OF EMPHASIS AND TIME IS CONDUCTED AND
MEASURED IN ACCORDANCE WITH JANSSEN'S STANDARD OPERATING PROCEDURES FOR ITS OWN
PRODUCTS TO THE TARGET PHYSICIAN GROUP FOR THE PRODUCT.
1.96
"PRODUCT" MEANS ANY PHARMACEUTICAL PREPARATION IN FINAL COMMERCIAL FORM
CONTAINING THE PRODUCT CANDIDATE, FOR SALE BY PRESCRIPTION, OVER-THE-COUNTER OR
ANY OTHER METHOD. PRODUCT INCLUDES WITHOUT LIMITATION ANY COMBINATION PRODUCT.
1.97
"PRODUCT CANDIDATE" MEANS A PHARMACEUTICAL COMPOSITION CONTAINING A
COMPOUND AS AN ACTIVE INGREDIENT.
1.98
"PUBLISHING PARTY" SHALL HAVE THE MEANING SET FORTH IN SECTION 11.3.
1.99
"REGULATORY APPROVAL" MEANS, WITH RESPECT TO ANY COUNTRY OR REGION, ALL
AUTHORIZATIONS BY THE APPROPRIATE GOVERNMENTAL ENTITY OR ENTITIES NECESSARY FOR
COMMERCIAL SALE OF A PRODUCT IN THAT COUNTRY OR REGION (NOT INCLUDING PRICING OR
REIMBURSEMENT APPROVAL). "REGULATORY APPROVAL" IN THE UNITED STATES SHALL MEAN
FINAL APPROVAL OF AN NDA PURSUANT TO 21 CFR §314 (OR ANY SUCCESSOR REGULATION
HAVING THE SAME PURPOSE OR EFFECT), PERMITTING MARKETING OF A PRODUCT IN
INTERSTATE COMMERCE IN THE UNITED STATES. "REGULATORY APPROVAL" IN THE EUROPEAN
UNION SHALL MEAN FINAL APPROVAL OF A MAA PURSUANT TO COUNCIL DIRECTIVE
75/319/EEC, AS AMENDED, OR COUNCIL REGULATION 2309/93/EEC, AS AMENDED, OR
PURSUANT TO ANY SUCCESSOR REGULATION HAVING THE SAME PURPOSE OR EFFECT.
1.100
"REGULATORY AUTHORITY" SHALL MEAN ANY APPLICABLE GOVERNMENT REGULATORY
AUTHORITY INVOLVED IN GRANTING APPROVALS FOR THE MANUFACTURING, MARKETING AND
SALE OF A PRODUCT.
1.101
"RELATED PARTY" SHALL MEAN EACH OF A PARTY'S AFFILIATES AND ANY PERMITTED
SUBLICENSEES,