manufacturing and
quality control of DRUG SUBSTANCE and PRODUCT as reasonably requested by
HORIZON, but HORIZON shall be the leading party and thus be responsible for
co-ordination of all regulatory matters. Notwithstanding the foregoing, as of
the EFFECTIVE DATE and until registration of HORIZON as manufacturing
authorisation holder for IMUKIN PRODUCT in each of the countries listed in
Exhibit 12 (TERRITORY) where a manufacturing authorization exists, BI shall be
responsible for all contacts with the HEALTH AUTHORITIES for IMUKIN PRODUCT in
said country/countries in accordance with the terms of the TRANSITION SERVICES
AGREEMENT. Following the registration of HORIZON as manufacturing authorisation
holder for IMUKIN PRODUCT in a country, HORIZON shall be responsible for all
contacts with the HEALTH AUTHORITIES for IMUKIN PRODUCT in such country.
HORIZON will notify BI in due time, but in no event later than [...***...]
in advance of any meeting with any HEALTH AUTHORITIES with regard to
manufacture, supply and quality control of the DRUG SUBSTANCE and/or PRODUCT
manufactured by BI under this AGREEMENT. BI shall have the right to participate
in such meetings with such HEALTH AUTHORITIES during the portion of such
meetings relating to BI's manufacture, supply and quality control of the DRUG
SUBSTANCE and/or PRODUCT.
BI will be responsible for drawing up the annual report required by the
HEALTH AUTHORITIES reasonably in advance of the due date, and will be
responsible of matters
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regarding the manufacture of PRODUCT. HORIZON shall submit such report to the
HEALTH AUTHORITIES and shall provide BI with a copy of the finally submitted
report.
3.1.3 Shipment of Material by HORIZON
Any materials, e.g. samples, sent by HORIZON (or by a Third Party on behalf of
HORIZON) to BI under this AGREEMENT shall be made by shipment from HORIZON's
facility (or the Third Party's facility, as the case may be) to BI shall be made
[*...***...] to the FACILITY in Vienna. Thus, shipping costs including insurance
will be borne by HORIZON, and risk of loss in transit shall lie with HORIZON.
Along with each shipment, HORIZON shall provide to BI, as applicable, shipping
documents indicating [...***...].
3.2 BI's Tasks and Responsibilities
3.2.1 Regulatory Support
BI agrees to co-operate with HORIZON in obtaining and maintaining all
governmental approvals and registrations in the TERRITORY relevant to the
chemistry, manufacturing and control ("CMC") section of the registration dossier
(and their foreign equivalents) for the PRODUCT as requested by HORIZON.
The Parties shall consult with each other concerning the scope and
content of all regulatory filings pertinent to BI's responsibilities for
manufacture and supply of PRODUCT, and shall jointly define the requirements for
the necessary PRODUCT registration with the applicable HEALTH AUTHORITIES so
that BI shall be able to fulfill its obligations under this AGREEMENT with
respect to the CMC portion of such PRODUCT registration. With respect to any
part of the CMC portion which contains INFORMATION of BI and/or its AFFILIATES,
BI shall be provided an opportunity