shall provide reasonable assistance to HORIZON for any action which
may be necessary to assign or otherwise transfer any rights to HORIZON
IMPROVEMENTS contemplated by this Section 8.3. BI shall notify HORIZON in
writing within [...***...] of becoming aware of any HORIZON IMPROVEMENTS.
8.4 BI shall have the exclusive ownership of all BI IMPROVEMENTS. [...***...].
HORIZON agrees to assign and hereby assigns to BI (and/or any designated
AFFILIATE) all right, title and interest it may have in any BI IMPROVEMENTS.
HORIZON shall ensure that all entities and individuals that perform any work are
subject to an obligation to assign (directly or through their employer) all
rights in BI IMPROVEMENTS to HORIZON, so that they may be further assigned to BI
(and/or any designated AFFILIATE) as set forth above. HORIZON shall provide
reasonable assistance to BI (and/or any designated AFFILIATE) for any action
which may be necessary to assign or otherwise transfer such rights to BI
IMPROVEMENTS contemplated by this Section 8.4.
8.5 BI hereby grants to HORIZON a non-exclusive, perpetual (subject to Horizon's
payment of all undisputed amounts under this AGREEMENT), sublicenseable (through
multiple tiers), royalty free license under the BI IMPROVEMENTS and BI
BACKGROUND IP (i) to the extent necessary to develop, use, import, offer for
sale and sell products containing INTERFERON GAMMA 1b in the name and on the
account of HORIZON (or its successor in interest) throughout the world, and
(ii) in the event HORIZON is entitled to request a TECHNOLOGY TRANSFER in
accordance with Section 14.4.1, to make and have made products containing
INTERFERON GAMMA 1b in the name and on account of HORIZON (or
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its successor in interest) throughout the world, whereby in each case HORIZON
shall assume the costs to be paid by BI for awards to inventors of BI
IMPROVEMENTS, as such awards are set forth in written agreements between BI and
such inventor or in an applicable industry labor contract or mandatory by
applicable laws, but solely to the extent that BI has given HORIZON written
notice of such costs and inventors.
8.6 HORIZON hereby grants to BI a non-exclusive, nonsublicensable (except to
BI's AFFILIATES and PERMITTED SUBCONTRACTORS solely to perform the services
under and in accordance with this Agreement, without the right to further
sublicense) license to use HORIZON BACKGROUND IP and HORIZON IMPROVEMENTS solely
for the purpose of manufacturing PRODUCT and DRUG SUBSTANCE for HORIZON, as
provided in this AGREEMENT. The license granted under this Section 8.6 shall
automatically terminate upon the expiration or effective termination of this
AGREEMENT.
9. COMPLAINTS; ADVERSE EVENTS; RECALLS
9.1 Each Party shall inform the other Party of any complaints, adverse reaction
reports, safety issues or toxicity issues relating to any PRODUCT in accordance
with the SDEA (as defined in Section ) and/or the QUALITY ASSURANCE
AGREEMENT.
9.2 Recalls
9.2.1 HORIZON shall notify BI within [...***...] if any DELIVERED MATERIAL
(including, without limitation, clinical trial material) manufactured by BI
hereunder is the subject of