Compound or Licensed Product.
Each party will provide the
other with annual reports and any required interim reports describing any other
side effects related to the utilization or medical administration of such
Licensed Compound or Licensed Product, which would allow appropriate reporting
in their respective territories in accordance with ICH guidelines or other
relevant guidelines.
12.5
RECALLS.
(A)
IF EITHER PARTY HAS GROUNDS TO BELIEVE THAT
A RECALL SHOULD BE CONDUCTED, THE PARTY WITH SUCH BELIEF SHALL IMMEDIATELY
NOTIFY THE OTHER PARTY IN WRITING OF SUCH GROUNDS.
(B)
IN THE EVENT OF ANY RECALL OR OTHER SIMILAR
GOVERNMENTAL ACTION WITH RESPECT TO ANY LICENSED PRODUCT IN THE TERRITORY,
ANORMED SHALL PROVIDE NEORX WITH REASONABLE CO-OPERATION AND TAKE SUCH OTHER
ACTIONS IN CONNECTION THEREWITH AS NEORX MAY REASONABLY REQUEST.
NEORX SHALL
HAVE THE SOLE RESPONSIBILITY TO IMPLEMENT ANY RECALL IN RESPECT OF LICENSED
PRODUCTS.
(C)
IN THE EVENT OF ANY RECALL OR OTHER SIMILAR
GOVERNMENTAL ACTION OUTSIDE THE TERRITORY WITH RESPECT TO ANY LICENSED PRODUCTS,
NEORX SHALL PROVIDE ANORMED WITH REASONABLE CO-OPERATION IN CONNECTION
THEREWITH.
ARTICLE 13 REPRESENTATIONS, WARRANTIES AND COVENANTS.
13.1
ANORMED'S REPRESENTATIONS, WARRANTIES AND COVENANTS.
AnorMED hereby represents, warrants and covenants to NeoRx as follows:
(A)
ANORMED HAS BEEN DULY ORGANIZED AND IS
VALIDLY SUBSISTING AND IN GOOD STANDING IN ITS JURISDICTION OF ORGANIZATION AND
HAS THE POWER TO CARRY ON THE BUSINESS AS NOW BEING CONDUCTED BY IT;
(B)
ANORMED HAS OBTAINED ALL NECESSARY CONSENTS,
APPROVALS AND AUTHORIZATIONS REQUIRED TO BE OBTAINED BY ANORMED IN CONNECTION
WITH THE EXECUTION AND DELIVERY OF THIS AGREEMENT AND HAS THE RIGHT TO ENTER
INTO THIS AGREEMENT, AND THIS AGREEMENT IS A LEGAL AND VALID OBLIGATION BINDING
UPON ANORMED AND ENFORCEABLE IN ACCORDANCE WITH ITS TERMS;
22
(C)
ANORMED IS THE OWNER OF, OR OTHERWISE HAS A
RIGHT TO GRANT LICENSES UNDER, THE ANORMED KNOW-HOW AND THE ANORMED PATENTS;
(D)
ANORMED DOES NOT OWN OR OTHERWISE CONTROL
ANY PATENT RELATING TO THE LICENSED COMPOUND OR THE LICENSED PRODUCT EXCEPT FOR
THE PATENTS WITHIN THE ANORMED PATENTS;
(E)
ANORMED IS NOT AWARE OF ANY GROUNDS TO
SUPPORT ANY ARGUMENT FOR FINDING ANY PATENT WITHIN THE ANORMED PATENTS INVALID
OR UNENFORCEABLE;
(F)
ANORMED HAS NOT ENTERED INTO AND IS NOT
SUBJECT TO ANY AGREEMENT UNDER WHICH IT HAS LICENSED IN THE FIELD IN THE
TERRITORY ANY RIGHTS TO A THIRD PARTY UNDER THE ANORMED KNOW-HOW OR THE ANORMED
PATENTS TO MAKE, USE, OFFER FOR SALE, SELL OR IMPORT ANY LICENSED COMPOUND OR
ANY LICENSED PRODUCT;
(G)
ANORMED HAS NOT RECEIVED ANY WRITTEN NOTICE,
AND IS NOT AWARE, OF ANY INFRINGEMENT WITH RESPECT TO ANY OF THE ANORMED
PATENTS;
(H)
ANORMED HAS NOT MADE AS OF THE EFFECTIVE
DATE AND WILL NOT MAKE DURING THE TERM ANY COMMITMENT TO ANY THIRD PARTY THAT IS
INCONSISTENT WITH OR IN DEROGATION OF THE RIGHTS GRANTED BY ANORMED TO NEORX OR
ANORMED'S OBLIGATIONS UNDER THIS AGREEMENT; AND
(I)
ANORMED IS NOT SUBJECT TO ANY OBLIGATION
THAT WOULD PREVENT IT FROM ENTERING INTO OR CARRYING OUT ITS OBLIGATIONS