10-Q
MEDICINES CO /DE filed this form 10-Q on 15 May 2002
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      To the extent permitted by Law, Nycomed shall have sole responsibility for
Pharmacovigilance and for submitting Adverse Event/medical safety reports in the
Territory, as may be required by the Government Authorities or regulations.

      Nycomed shall not submit Adverse Event or safety reports to Government
Authorities without first consulting TMC's designated drug surveillance and
information .

      The Parties shall enter into a separate Pharmacovigilance agreement within
thirty (30) days after the Effective Date.

13.2. Cooperation/Procedures.

      TMC shall also be responsible for maintaining a central Adverse
Event/medical safety database for the Product. The Parties shall cooperate
towards establishing and maintaining such database. Reports based on this
database will be made available to Nycomed during the term of the Agreement, as
necessary, to meet the requirements of Government Authorities in the Territory.
Without limiting the generality of the foregoing, Nycomed and TMC shall work
together to develop standard operating procedures for exchange of information
concerning Adverse Events and Product safety information derived from Product
use in the Territory and each Party shall at all times comply with the
procedures developed.

13.3. Recalls.

      In the event that either Party determines that an event, incident or
circumstance has occurred which may result in the need for a recall or other
removal of the Product, or any lot or lots thereof, from the market, such Party
shall advise the other and the Parties shall consult with respect thereto in
accordance with the technical agreement between the Parties. TMC shall have
authority to decide whether a recall or other removal of such Product shall be
made. The cost of recall and removing and destroying the Products recalled shall
be borne by TMC. TMC shall, at Nycomed's discretion, reimburse or credit the
Products recalled to Nycomed at the Transfer Price paid by Nycomed for such
Products.

14. TRADEMARKS

14.1 Right to Use

      Nycomed shall use the Trademarks on an exclusive basis with respect to
Exhibit C part a) and on a non-exclusive basis with respect to Exhibit C part b)
during the term of this Agreement in the Territory solely for display,
advertising, labeling and packaging purposes in connection with marketing,
selling and distributing the Product in accordance with this Agreement. Nycomed
shall not at any time do or permit any act to be done which may in any way
impair the rights of TMC in the Trademarks. TMC shall at all times retain sole
and exclusive ownership of the Trademarks. TMC agrees that, if required by the
laws of any country


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