grant sublicenses to Chiron.
4.5.
NO DEBARRED PERSONNEL.
IN THE COURSE OF THE DEVELOPMENT OF LICENSED
PRODUCTS, NEITHER PARTY SHALL USE, DURING THE TERM OF THIS AGREEMENT, THE
SERVICES OF ANY EMPLOYEE OR CONSULTANT THAT HAS BEEN DEBARRED BY THE FDA OR
REGULATORY AUTHORITIES, OR, TO THE BEST OF SUCH PARTY'S KNOWLEDGE, IS THE
SUBJECT OF DEBARMENT PROCEEDINGS BY THE FDA OR REGULATORY AUTHORITIES.
4.6.
CHIRON COMPLIANCE.
IN CONNECTION WITH ANY DEVELOPMENT ACTIVITIES
UNDERTAKEN BY CHIRON IN CONNECTION WITH ANY LICENSED PRODUCT, CHIRON SHALL
COMPLY WITH ALL APPLICABLE LAWS AND REGULATIONS REGARDING THE CARE AND USE OF
EXPERIMENTAL ANIMALS, AS SUCH LAWS AND REGULATIONS ARE IN EFFECT WHERE SUCH
DEVELOPMENT ACTIVITIES ARE UNDERTAKEN.
ALL ANIMALS USED BY CHIRON TO EVALUATE
DAPTOMYCIN OR ANY LICENSED PRODUCT SHALL BE PROVIDED HUMANE CARE AND TREATMENT
IN ACCORDANCE WITH THE MOST ACCEPTABLE VETERINARY PRACTICES.
ARTICLE 5.
REGULATORY
5.1.
REGULATORY PLAN; DILIGENCE OBLIGATION.
(A)
CUBIST'S AND OTHER LICENSEES' ACTIVITIES.
CUBIST SHALL PREPARE AND
PRESENT TO CHIRON VIA THE JCT, AND UPDATE ANNUALLY, ITS REGULATORY PLAN FOR THE
LICENSED PRODUCTS OUTSIDE OF THE TERRITORY.
CUBIST SHALL KEEP CHIRON APPRISED
OF THE STATUS OF CUBIST'S AND THE OTHER LICENSEES' EFFORTS TO OBTAIN REGULATORY
APPROVAL IN COUNTRIES OUTSIDE OF THE TERRITORY.
PRIOR TO MAKING ANY DECISION TO
ABANDON ANY EFFORTS AND ACTIVITIES SET FORTH IN SUCH REGULATORY PLAN TO OBTAIN
REGULATORY APPROVAL IN THE UNITED STATES FOR A LICENSED PRODUCT (OR FOR AN
INDICATION OR FORMULATION OF SAME), CUBIST SHALL HAVE FIRST PROVIDED ITS REASONS
IN SUPPORT OF SUCH DECISION TO CHIRON VIA THE JCT AND THE JCT SHALL HAVE MET TO
DISCUSS THE REASONS FOR SUCH DECISION.
(B)
REGULATORY PLAN.
WITHIN THE TIME PERIOD SET FORTH IN SECTION 5.1(C)(I),
CHIRON SHALL PREPARE AND DELIVER TO CUBIST ONE REGULATORY PLAN FOR THE
TERRITORY, WHICH REGULATORY PLAN SHALL SET FORTH CHIRON'S PLAN, STRATEGY AND
PROPOSED ACTIVITIES TO OBTAIN REGULATORY APPROVAL IN THE TERRITORY FOR THE
LAUNCH INDICATION(S) (THE "REGULATORY PLAN").
THE REGULATORY PLAN MAY INCLUDE,
AS APPROPRIATE AND WITHOUT LIMITATION, THE FOLLOWING ELEMENTS:
(i)
Chiron's general strategy for seeking Regulatory Approval for the
Launch Indication(s) in the Major Market Countries;
(ii)
Chiron's plans for the preparation and filing of applications for
Regulatory Approval for the Launch Indication(s) in the Major Market Countries;
(iii)
Chiron's general strategy for seeking Regulatory Approval for the
Launch Indication(s) in the remaining countries of the Territory, however such
outline may at Chiron's sole discretion deal with such remaining countries
individually or in the aggregate;
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
28
(iv)
if known, a description of any clinical studies or clinical data
that will be necessary in order to obtain Regulatory Approval in the countries
referenced in the foregoing clauses (i)-(iii) of this Section 5.1(b), with
respect to the Launch Indication(s), and a discussion of the impact of any such
clinical studies or clinical data requirement on the timing of obtaining
Regulatory Approval for the Launch Indication(s) in such country or countries;
and
(v)