COOPERATE IN
GOOD FAITH TO FACILITATE (I) THE DEVELOPMENT OF PROCESS FOR API PRODUCTION AND
(II) THE UNINTERRUPTED SUPPLY OF API TO PAR.
IN SUPPORT OF THE FOREGOING, THE
PARTIES AGREE TO ESTABLISH A COMMITTEE (THE "DEVELOPMENT COMMITTEE") TO ENSURE
THE ACCOMPLISHMENT OF THOSE GOALS AND TO ALLOW FOR THE NECESSARY COMMUNICATIONS
BETWEEN THE PARTIES.
5.4.1
THE DEVELOPMENT COMMITTEE SHALL BE MADE UP OF SIX (6) PEOPLE IN
TOTAL.
EACH PARTY SHALL HAVE EQUAL REPRESENTATION IN THE DEVELOPMENT
COMMITTEE.
EACH PARTY SHALL HAVE THE RIGHT FROM TIME TO TIME TO SUBSTITUTE NEW
MEMBERS, ON A PERMANENT OR TEMPORARY BASIS, FOR ANY OF ITS PREVIOUSLY DESIGNATED
MEMBERS OF THE DEVELOPMENT COMMITTEE.
EACH PARTY SHALL BEAR ITS OWN COSTS
ASSOCIATED WITH PARTICIPATION IN THE DEVELOPMENT COMMITTEE.
5.4.2
THE DEVELOPMENT COMMITTEE SHALL:
(A)
MAKE RECOMMENDATIONS AND SUGGESTIONS TO ENABLE EACH PARTY FULFILL
ITS OBLIGATIONS UNDER THIS AGREEMENT AS EFFICIENTLY AS POSSIBLE;
(B)
FACILITATE COMMUNICATION REGARDING, AND RESOLUTION OF, ANY
DISPUTES BETWEEN THE PARTIES; AND
(C)
COORDINATE THE EXCHANGE OF INFORMATION, TECHNOLOGY AND KNOW-HOW AS
APPLICABLE TO THIS AGREEMENT.
5.4.3
THE DEVELOPMENT COMMITTEE SHALL NOT HAVE THE AUTHORITY OR POWER TO
IMPOSE FINANCIAL COSTS OR OTHER OBLIGATIONS ON EITHER PARTY ABOVE THOSE STATED
IN THIS AGREEMENT.
7
ARTICLE 6
BIOCON'S QUALITY CONTROL OBLIGATIONS
6.1
BIOCON OBLIGATIONS.
BIOCON SHALL USE ITS BEST COMMERCIAL EFFORTS
TO ENSURE THAT ALL API SUPPLIED TO PAR UNDER THE TERMS OF THIS AGREEMENT WILL:
(a)
conform in all respects to the API Specifications and Quality
Agreement (defined below);
(b)
be manufactured in conformity with cGMP;
(c)
be of merchantable quality;
(d)
conform with all applicable material requirements of any and all
Product Approvals granted for the Products within the Territory; and
(e)
meet any other material current pharmacopoeia or regulatory
requirements of all relevant Regulatory Authorities in the Territory.
6.1.1
PACKAGING.
BIOCON SHALL ENSURE THAT EACH BATCH OF API IS LABELED
AND EACH OF THE BATCH NUMBERS IS APPLIED TO EACH BATCH, AS REQUIRED BY THE
APPLICABLE REGULATORY AUTHORITIES.
BIOCON SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO PROVIDE PAR WITH API WITH A MINIMUM SHELF LIFE, BEFORE ANY RETEST, OF
[***] ([***]) MONTHS FROM THE DATE OF DELIVERY TO PAR.
DUE TO THE CURRENT THE
LACK OF STABILITY DATA FOR THE API, THE PARTIES AGREE TO NEGOTIATE IN GOOD FAITH
MORE DEFINITE STABILITY PARAMETERS TO BE INCLUDED IN THE QUALITY AGREEMENT
(DEFINED BELOW).
IN THE EVENT SUCH PROVISION IN THE QUALITY AGREEMENT REGARDING
API STABILITY CONFLICTS WITH OR IS INCONSISTENT WITH THIS AGREEMENT, THAT
PROVISION IN THE QUALITY AGREEMENT SHALL GOVERN AND CONTROL.
BIOCON SHALL
ENSURE THAT A COPY OF THE CERTIFICATE OF ANALYSIS (AS DEFINED IN THE QUALITY
AGREEMENT) WITH RESPECT TO EACH BATCH OF API SUPPLIED TO PAR ACCOMPANIES EACH
BATCH.
BIOCON WILL ALSO ENSURE THAT ALL DOCUMENTATION REASONABLY REQUIRED BY
PAR SHALL BE MADE AVAILABLE TO PAR UPON REQUEST.
6.1.2
SHIPMENT AND STORAGE.
BIOCON SHALL PROVIDE AND MAINTAIN SUITABLE
STORAGE AND TRANSPORT CONDITIONS FOR EACH BATCH OF API AND SHALL PROVIDE PAR
WITH COMPLETE WRITTEN INSTRUCTIONS WITH