TO THE FDA WITHIN 15 CALENDAR DAYS.
SECTION 1.10
"ANNUAL PLAN" HAS THE MEANING SET FORTH IN SECTION 4.5.
SECTION 1.11
"CGMP" SHALL MEAN CURRENT "GOOD MANUFACTURING PRACTICES"
AS SUCH TERM IS DEFINED FROM TIME TO TIME BY THE FDA OR OTHER RELEVANT
GOVERNMENTAL AUTHORITY HAVING JURISDICTION OVER THE MANUFACTURE OR SALE OF THE
PRODUCT PURSUANT TO ITS REGULATIONS, GUIDELINES OR OTHERWISE.
SECTION 1.12
"CHANNEL" SHALL MEAN THE LONG-TERM SALES CHANNEL AS
REPORTED IN THE PRESCRIBER DATA, WHICH INCLUDES BUT IS NOT LIMITED TO NURSING
HOMES AND ASSISTED LIVING FACILITIES.
SECTION 1.13
CO-CHAIRS" HAS THE MEANING SET FORTH IN SECTION 3.2.
SECTION 1.14
"COGS" MEANS, FOR A PARTICULAR PERIOD, DEPOMED'S EXPENSES
FOR COST OF GOODS SOLD (CALCULATED IN ACCORDANCE WITH SECTION 7.2(D)) FOR
PRODUCT IN THE TERRITORY FOR SUCH PERIOD INCLUDING ANY EXPENSES INCURRED
DIRECTLY IN CONNECTION WITH THE DISTRIBUTION OF THE PRODUCT IN THE TERRITORY.
THE COGS AS OF THE INITIAL EFFECTIVE DATE IS SET FORTH ON SCHEDULE 1.14.
SECTION 1.15
"CONFIDENTIALITY AGREEMENT" MEANS THAT CERTAIN
CONFIDENTIALITY AGREEMENT, DATED AS OF FEBRUARY 26, 2007, BETWEEN DEPOMED AND
WATSON.
SECTION 1.16
"CONTROL" OR "CONTROLLED" MEANS, WITH RESPECT TO PATENTS,
KNOW-HOW OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY KIND, THE POSSESSION BY A
PARTY OF THE ABILITY TO GRANT A LICENSE OR SUBLICENSE OF SUCH RIGHTS WITHOUT THE
PAYMENT OF ADDITIONAL CONSIDERATION AND WITHOUT VIOLATING THE TERMS OF ANY
AGREEMENT OR ARRANGEMENT BETWEEN SUCH PARTY AND ANY THIRD PARTY.
SECTION 1.17
"DDMAC" MEANS THE FDA'S DIVISION OF DRUG MARKETING,
ADVERTISING AND COMMUNICATIONS.
SECTION 1.18
"DEPOMED" HAS THE MEANING SET FORTH IN THE PREAMBLE TO
THIS AGREEMENT.
SECTION 1.19
"DEPOMED APL" MEANS DEPOMED'S ADVERTISING AND PROMOTIONAL
LABELING COMMITTEE RESPONSIBLE FOR REVIEWING AND APPROVING PROMOTIONAL MATERIALS
RELATED TO THE PRODUCT.
SECTION 1.20
"DEPOMED TRADEMARKS" MEANS (A) THE PROQUIN® TRADEMARK,
(B) THE ACUFORMTM TRADEMARK, FOR WHICH DEPOMED HAS SOUGHT REGISTRATION FOR IN
THE UNITED STATES PATENT AND TRADEMARK OFFICE, AND (C) DEPOMED®, AND, IN EACH
CASE, ALL RELATED DOMAIN NAMES, SUCCESSOR TRADEMARKS AND OTHER TRADEMARK RELATED
RIGHTS. THE DEPOMED TRADEMARKS ARE ATTACHED HERETO AS SCHEDULE 1.20.
SECTION 1.21
"DETAIL" MEANS AN IN-PERSON, FACE-TO-FACE SALES
PRESENTATION OF THE PRODUCT MADE BY A SALES REPRESENTATIVE TO A PROFESSIONAL,
INCLUDING A P1 DETAIL OR A P2 DETAIL, AND AFTER DECEMBER 31, 2008, A P3 DETAIL.
SECTION 1.22
"DETAIL MINIMUM" MEANS, FOR A PARTICULAR PERIOD, THE SUM
OF (A) THE UROLOGY DETAIL MINIMUM FOR SUCH PERIOD, PLUS (B) THE OB/GYN DETAIL
MINIMUM FOR SUCH PERIOD.
SECTION 1.23
"DETAIL SHORTFALL" MEANS, FOR A PARTICULAR PERIOD, THE
REMAINDER OF (A) THE DETAIL MINIMUM FOR SUCH PERIOD, MINUS (B) THE ACTUAL NUMBER
OF PDES PERFORMED DURING SUCH PERIOD. IN DETERMINING THE ACTUAL NUMBER OF PDES
PERFORMED DURING ANY PERIOD (INCLUDING WITHOUT LIMITATION FOR PURPOSES OF
SECTION 8.2(A)):
(A) ONLY PDES PERFORMED ON PROFESSIONALS ON THE WATSON
PHYSICIAN LIST SHALL BE TAKEN INTO ACCOUNT; AND (B) NOT MORE THAN 100% OF THE P1
DETAILS, 100% OF THE P2 DETAILS AND 100% OF THE P3 DETAILS (IF APPLICABLE)
REQUIRED TO BE PERFORMED