UNDER THIS AGREEMENT OR THROUGH
DEPOMED'S USE OF THE WATSON TRADEMARKS, IT BEING THE INTENTION OF THE PARTIES
THAT ALL GOODWILL AND IMPROVED REPUTATION GENERATED BY DEPOMED AND USE OF THE
WATSON TRADEMARKS SHALL INURE TO THE BENEFIT OF WATSON.
(C)
EACH OF WATSON WITH RESPECT TO ITS USE OF THE DEPOMED TRADEMARKS
AND DEPOMED WITH RESPECT TO ITS USE OF THE WATSON TRADEMARKS WILL MAINTAIN
QUALITY STANDARDS FOR ALL OF ITS USES OF THE TRADEMARKS OF THE OTHER PARTY IN
CONNECTION WITH THE PROMOTION OF THE PRODUCT THAT ARE SUBSTANTIALLY EQUIVALENT
TO THOSE STANDARDS USED BY THE OWNER OF SUCH TRADEMARKS IN CONNECTION WITH
PHARMACEUTICAL PRODUCTS. SUBJECT TO THE FOREGOING AND TO THE OTHER PROVISIONS OF
THIS AGREEMENT, EACH PARTY ACKNOWLEDGES AND AGREES THAT THE OWNER OR LICENSEE OF
THE TRADEMARK HAS THE RIGHT, AT ANY TIME, TO MODIFY OR SUPPLEMENT SUCH QUALITY
STANDARDS AND THAT THE LICENSEE OR SUBLICENSEE MUST IMPLEMENT SUCH NEW STANDARDS
OR CHANGES FOLLOWING RECEIPT OF NOTICE OF SUCH ADDITIONS OR CHANGES; PROVIDED
THAT THE LICENSOR AGREES TO BEAR ALL REASONABLE COSTS ASSOCIATED WITH SUCH
MODIFICATIONS AND SUPPLEMENTS.
ARTICLE V
CLINICAL AND REGULATORY AFFAIRS; DEVELOPMENT
SECTION 5.1
REGULATORY APPROVALS. DEPOMED SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO MAINTAIN AND CONTINUE ALL REGULATORY APPROVALS CURRENTLY
IN EFFECT FOR THE PRODUCT. WATSON AGREES THAT ALL REGULATORY APPROVALS,
APPLICATIONS THEREFOR AND ANY OTHER SUBMISSIONS TO A GOVERNMENTAL AUTHORITY WITH
RESPECT TO THE PRODUCT SHALL BE IN THE NAME OF, AND SHALL BE OWNED BY, DEPOMED
OR ITS DESIGNEE.
SECTION 5.2
COMPLIANCE WITH REGULATORY REQUIREMENTS. UNLESS
OTHERWISE REQUIRED BY LAW OR EXPRESSLY REQUIRED BY THIS AGREEMENT, DEPOMED WILL
RETAIN EXCLUSIVE AUTHORITY OVER AND RESPONSIBILITY FOR COMPLYING WITH ALL
REGULATORY REQUIREMENTS AND MAINTAINING ALL CONTACTS WITH GOVERNMENTAL
AUTHORITIES WITH RESPECT TO THE PRODUCT, INCLUDING MAINTAINING AND UPDATING OF
THE NDA, THE DEVELOPMENT AND SUBMISSION OF APPLICATIONS FOR NEW INDICATIONS, THE
REPORTING OF ANY ADVERSE DRUG REACTIONS TO THE FDA, THE COMPLIANCE OF
PROMOTIONAL MATERIALS WITH FDA RULES AND REGULATIONS AND THE FILING OF
PROMOTIONAL MATERIALS WITH THE FDA.
5
SECTION 5.3
COMPLIANCE. IN PERFORMING ITS DUTIES HEREUNDER, EACH
PARTY SHALL, AND SHALL CAUSE ITS EMPLOYEES AND AGENTS (INCLUDING THE WATSON
SALES FORCE) TO, COMPLY WITH ALL LEGAL REQUIREMENTS, INCLUDING THE FDA'S
REGULATIONS AND GUIDELINES CONCERNING THE ADVERTISING OF PRESCRIPTION DRUG
PRODUCTS, DDMAC'S PROMOTIONAL GUIDELINES, THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES OFFICE OF THE INSPECTOR GENERAL COMPLIANCE PROGRAM GUIDANCE FOR
PHARMACEUTICAL MANUFACTURERS, THE AMERICAN MEDICAL ASSOCIATION'S GUIDELINES ON
GIFTS TO PHYSICIANS, THE PHRMA CODE ON INTERACTIONS WITH HEALTHCARE PROVIDERS,
THE PRESCRIPTION DRUG MARKETING ACT OF 1987, AS AMENDED, AND THE RULES AND
REGULATIONS PROMULGATED THEREUNDER, THE ACCME STANDARDS FOR COMMERCIAL SUPPORT
OF CONTINUING MEDICAL EDUCATION, EQUAL EMPLOYMENT, NON-DISCRIMINATION AND
FEDERAL AND STATE ANTI-KICKBACK LEGAL REQUIREMENTS, LEGAL REQUIREMENTS WITH
RESPECT TO SUBMISSION OF FALSE CLAIMS TO GOVERNMENTAL OR PRIVATE HEALTH CARE
PAYORS, AND ALL INDUSTRY AND PROFESSIONAL STANDARDS, WHICH MAY BE APPLICABLE TO
THE ACTIVITIES (INCLUDING THE WAREHOUSING, HANDLING AND DISTRIBUTION OF SAMPLES)
TO BE PERFORMED BY SUCH PARTY HEREUNDER. NONE