AND ANY
THIRD PARTY THAT MAY POTENTIALLY OR ACTUALLY SUBSEQUENTLY PERFORM SERVICES AND
FUNCTIONS PERFORMED BY NYCOMED UNDER THE NEW AGREEMENTS OR QUALITY AGREEMENTS
(THE "NEW DISTRIBUTORS"), WITH REASONABLE ACCESS TO ALL INFORMATION, DOCUMENTS,
RECORDS AND FACILITIES AND, SUBJECT TO CLAUSE (III) BELOW, ALL PERSONNEL,
CONTRACTORS AND AGENTS, IN EACH CASE AS REASONABLY NECESSARY (A) TO COMPLETE A
REASONABLE REVIEW AND ANALYSIS OF ACTIVITIES PERFORMED BY NYCOMED WITH RESPECT
TO THE PRODUCT (INCLUDING ACTIVITIES DIRECTED TO OBTAINING APPROVALS, MARKETING,
PROMOTING, DISTRIBUTING, IMPORTING OR SELLING THE PRODUCT) AS CUSTOMARY TO
EVALUATE THE SCOPE AND NATURE OF THE SERVICES AND FUNCTIONS TO BE PERFORMED BY
TMC OR THE NEW DISTRIBUTOR AND (B) TO REASONABLY ASSIST TMC IN TMC'S EFFORTS TO
BUILD ITS COMMERCIAL OPERATIONS WITH RESPECT TO THE PRODUCT, INCLUDING WITHOUT
LIMITATION TMC'S EFFORTS TO OBTAIN FOR TMC OR FOR ANY NEW DISTRIBUTOR ANY
APPROVALS NECESSARY TO PERFORM SERVICES AND FUNCTIONS PERFORMED BY NYCOMED UNDER
THE NEW AGREEMENTS OR QUALITY AGREEMENTS. WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING:
(i)
During the Transition Period, Nycomed
will provide TMC with frequent and complete ongoing reports with respect to all
activities performed by Nycomed under the Transaction Agreements and Quality
Agreements, including registration efforts and other regulatory matters, and
activities in connection with the marketing, promotion, distribution,
importation and sale the Product. To the extent applicable, the format of such
reports shall be consistent with past practice and shall contain at least as
much detail as in similar reports generated by Nycomed under the Former
Distribution Agreement.
(ii)
On or before the Transition Date, or with
respect to any item below, on such earlier date as is reasonably practicable
following notice by TMC to Nycomed,
18
Nycomed shall provide to TMC or any New Distributor all documents and records
related to the Product within the possession or control of Nycomed, in each case
whether existing as of the Effective Date or whether created, developed or
acquired by Nycomed during the Transition Period (the "Product Documents and
Records"), including without limitation:
(A)
documents and records related to Regulatory Filings and Approvals
(including documents and records relating to clinical trials and adverse events)
and any withdrawals or rejections of applications for Approvals, including
without limitation all documents, files and databases with respect to the
clinical trials set forth on Schedule 6.3.1;
(B)
documents (and conversation logs) of communications with
Governmental Authorities (excluding communications with respect to registrations
and applications for the Assigned Trademark Registrations, which are separately
addressed by clause (D) below);
(C)
marketing, pricing, sales and customer information, data and
materials, including without limitation: customer lists, marketing, distribution
and sales plans, methods and systems, sales figures and sales projections,
training materials and promotional and advertising materials, and all
translations of the foregoing; and
(D)
registrations and applications for the Assigned Trademark
Registrations and Assigned Domain Names, Nycomed's file with respect to any
pending applications for the Assigned Trademark Registrations, and the contact
information for the law firms or other agents Nycomed has used with respect