COURSE OF ACTION, WHICH MAY INCLUDE (BUT IS NOT LIMITED TO) REWORK OR
REPROCESSING OF SUCH NON-CONFORMING BATCH OR PRODUCTION OF A REPLACEMENT BATCH
AT ADDITIONAL COST TO PHARMATHENE.
6.
FORCE MAJEURE
Failure of either party to perform under this Agreement (except the obligation
to make payments) shall not subject such party to any liability to the other if
such failure is caused by acts of God, lightning, acts of terrorism,
earthquakes, fire, explosion, flood, drought, war, riot, sabotage, hijackings,
embargoes, blockades, strikes, labour disputes (excluding labour disputes
involving the work force or any part thereof of the party in question),
compliance with any order or regulation of any government entity, or by any
cause beyond the reasonable control of the affected party, whether or not
foreseeable, provided that written notice of such event is promptly given to the
other party.
For the avoidance of doubt, this provision shall not be applicable
in the event of failure of Drug Product in clinical trials or failure of Drug
Product to gain regulatory approval.
Page 17 of 29
CONFIDENTIAL
7.
CHANGES MANDATED BY REGULATORY AUTHORITY
7.1
DRUG SUBSTANCE-SPECIFIC CHANGES:
IF FACILITY,
EQUIPMENT, PROCESS OR SYSTEM CHANGES ARE REQUIRED OF AVECIA AS A RESULT OF A
CHANGE IN THE REGULATORY REQUIREMENTS OF A REGULATORY AUTHORITY, AND SUCH
REGULATORY CHANGES APPLY PRIMARILY TO THE PRODUCTION AND SUPPLY OF ONE OR MORE
OF DRUG SUBSTANCES, THEN PHARMATHENE AND AVECIA WILL REVIEW SUCH REQUIREMENTS
AND AGREE IN WRITING TO SUCH REGULATORY CHANGES, AND PHARMATHENE SHALL BEAR I00%
OF THE REASONABLE COSTS THEREOF.
7.2
GENERAL CHANGES:
IF SUCH REGULATORY CHANGES
APPLY GENERALLY TO ONE OR MORE DRUG SUBSTANCES AS WELL AS TO OTHER PRODUCTS
PRODUCED BY AVECIA FOR ITSELF OR FOR THIRD PARTIES, THEN AVECIA SHALL BEAR THE
COST OF THOSE CHANGES.
8.
CONFIDENTIALITY
8.1
CONFIDENTIALITY:
IT IS CONTEMPLATED THAT IN
THE COURSE OF THE PERFORMANCE OF THIS AGREEMENT EACH PARTY MAY, FROM TIME TO
TIME, DISCLOSE CONFIDENTIAL INFORMATION TO THE OTHER.
EXCEPT AS PERMITTED BY
THE AGREEMENT, EACH PARTY AGREES TO TAKE ALL REASONABLE STEPS TO PREVENT
DISCLOSURE OF CONFIDENTIAL INFORMATION OF THE OTHER PARTY TO THIRD PARTY.
EXCEPT FOR THE AVECIA TECHNOLOGY, ANY AND ALL INFORMATION, DATA, MATERIALS
INCLUDING CELL LINES, AND KNOW HOW THAT RELATES TO DRUG SUBSTANCE, DRUG PRODUCT
OR THE PRODUCTION OF DRUG SUBSTANCE AND/OR DRUG PRODUCT INCLUDING BUT NOT
LIMITED TO PHARMATHENE TECHNOLOGY IN THE POSSESSION OF OR WHICH COMES INTO THE
POSSESSION OF AVECIA SHALL BE DEEMED TO BE CONFIDENTIAL INFORMATION OF
PHARMATHENE THAT IS DISCLOSED TO AVECIA AND SHALL NOT BE SUBJECT TO ANY OF THE
EXCEPTIONS (I), (II) OR (IV) OF THE DEFINITION OF CONFIDENTIAL INFORMATION OF
SECTION 1.1.
NO PROVISION OF THIS AGREEMENT SHALL BE CONSTRUED SO AS TO
PRECLUDE DISCLOSURE OF CONFIDENTIAL INFORMATION AS MAY BE REASONABLY NECESSARY
TO SECURE FROM ANY GOVERNMENTAL AGENCY NECESSARY APPROVALS OR LICENSES OR TO
OBTAIN PATENTS WITH RESPECT TO THE DRUG PRODUCT OR THE DRUG SUBSTANCE.
8.2
THIRD PARTY DISCLOSURE:
AVECIA SHALL BE
PERMITTED TO DISCLOSE DRUG PRODUCT AND