agrees that
changes to the DRUG SUBSTANCE SPECIFICATIONS, PRODUCT SPECIFICATIONS or the
MANUFACTURING PROCESS during an ongoing campaign are not possible.
6.3.6 If any changes to the DRUG SUBSTANCE SPECIFICATIONS, PRODUCT
SPECIFICATIONS or the MANUFACTURING PROCESS render obsolete or unusable any
COMPONENTS and if and to the extent those COMPONENTS may not be returned to the
appropriate vendor for a credit, BI shall either destroy or deliver to HORIZON,
at HORIZON's sole option, those obsolete or unusable COMPONENTS. HORIZON shall
reimburse BI for the costs of such COMPONENTS destroyed or provided to HORIZON
to the extent the amount of COMPONENTS that would have been reasonably required
for BI to maintain in inventory in order to meet its obligations under this
AGREEMENT (consistent with its obligations under Section 5.2 hereof with respect
to the COMPONENTS).
6.3.7 HORIZON may request additional regulatory services support from BI (e.g.,
those set forth in Sections and 3.2) with respect to the DRUG SUBSTANCE
or PRODUCT, in support of either obtaining or maintaining regulatory approval in
any country of the TERRITORY. In such event, BI shall provide a quote of the
price of such services (which pricing shall be reasonable in nature and
consistent with industry standards), and shall provide such additional
regulatory services upon mutual agreement on the scope and price of such
services. For purposes of clarity and notwithstanding anything to the contrary
contained in this Agreement, for purposes of maintaining regulatory approvals
existing as of the EFFECTIVE DATE of this Agreement in any country of the
TERRITORY, BI will draw up the annual report required by the HEALTH AUTHORITIES
pursuant to Section , [...***...], without additional cost or expense to
HORIZON. All costs for any further stability studies requested by HORIZON shall
be borne by HORIZON, unless such further stability studies are necessary due to
BI's breach of this AGREEMENT, in which event BI shall bear the costs thereof.
HORIZON will inform BI in due time which regulatory support is requested from
BI. Further, all costs for any translation services that relate solely to such
regulatory services support from BIshall be borne directly by HORIZON.
6.3.8 HORIZON shall bear the costs for HEALTH AUTHORITY regulatory inspections
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that are solely related to PRODUCT as set forth in Section 6.3.2 and Exhibit 14.
With respect to HEALTH AUTHORITY regulatory inspections that are substantially
related to PRODUCT as well as other products, Horizon shall bear such costs
proportionally to the amount of time such inspection is specifically directed to
the PRODUCT relative to the entirety of the inspection, and solely to the extent
that such costs are not incurred by BI in the ordinary course of its business.
For clarity, any costs incurred in connection with inspections that relate to
the manufacture, use, sale or other disposition of IMUKIN PRODUCT by or on
behalf of BI prior to the Closing Date (as defined in the ASSET PURCHASE
AGREEMENT) shall be borne by BI.
6.4