to provide a Deferral Notice within
[***], or to provide a Post-POC Plan Dispute Notice within [***] after receipt
of an Initial Opt-In Report therefor), (w) Sanofi has timely provided a Deferral
Notice with respect to a Product Candidate Family but fails to exercise its
Opt-In Rights during the Deferred Opt-In Period, or Extended Opt-In Period (if
and as applicable) therefor, (x) Regeneron has provided a Breakthrough Opt-In
Report with respect to a Product Candidate Family and Sanofi fails to exercise
its Opt-In Rights within the Breakthrough Opt-In Period or Extended Opt-In
Period (if and as applicable) therefor, or (y) if Sanofi notifies Regeneron in
writing that it will not exercise its Opt-In Rights with respect to a Product
Candidate Family during the Initial Opt-In Period (or the Deferred Opt-In
Period, the Breakthrough Opt-In Period or the Extended Opt-In Period, if and as
applicable) therefor (each such action or inaction described in clauses (v)-(y)
(inclusive), an "Opt-Out"), then, in each such case, the following shall apply:
(a)
Refused Candidate. Sanofi's Opt-In Rights shall expire with respect to
such Product Candidate Family, and each member of such Product Candidate Family
shall automatically become a "Refused Candidate" for purposes of this Agreement.
Following such time as the members of a Product Candidate Family become Refused
Candidates, Sanofi shall no longer have any rights to such Product Candidate
Family under this Agreement or the IO License and Collaboration Agreement. For
clarity, [***], Regeneron shall not owe any
39
royalty or other payments to Sanofi under any Ancillary Collaboration Agreement
with respect to any such Refused Candidate.
(b)
Regeneron Rights. Regeneron may (i) continue to develop, manufacture and
commercialize (on its own or with one or more Third Parties) any Refused
Candidate without restriction outside of this Agreement and any Ancillary
Collaboration Agreement, and (ii) practice and use [***]. For clarity, subject
to Section 2.9, Regeneron may continue to develop and commercialize such Refused
Candidates for use with one (1) or more other IO Antibodies (including IO
Antibodies controlled by Regeneron or its Affiliates or by other Persons).
(c)
Sanofi Rights and Obligations. Neither Sanofi nor its Affiliates, either
directly, or with or through any Third Party, may develop or commercialize (i)
any Refused Candidate or (ii) any IO Antibody that targets the same IO Target
Profile as such Refused Candidate, until the [***]; provided, that if as a
result of [***] such restriction shall not apply, and Sanofi and its Affiliates
shall be free to develop [***].
5.4
Additional Development Prior to Opt-In. From and after Regeneron's
delivery to Sanofi of an Initial Opt-In Report, Deferred Opt-In Report or
Breakthrough Opt-In Report with respect to a Product Candidate Family until
Sanofi's exercise of its Opt-In Rights (or an Opt-Out) with respect to such
Product Candidate Family, [***]. After delivery of an Initial Opt-In Report or,
if earlier, a Breakthrough Opt-In Report with respect to a Product Candidate
Family, as applicable, to Sanofi and prior to Sanofi exercising its Opt-In
Rights (or an