Biosimilar Applications. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (“PHSA”) (a “Biosimilar Application”) naming Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will, [***].
Appears in 5 contracts
Samples: License Agreement (2seventy Bio, Inc.), License Agreement (2seventy Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Biosimilar Applications. (a) If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (“PHSA”) or comparable provisions of Applicable Laws in any other jurisdiction (a “Biosimilar Application”) naming Licensed a Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will, [***].) or any
Appears in 2 contracts
Samples: License and Collaboration Agreement, License and Collaboration Agreement (Mannkind Corp)
Biosimilar Applications. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (“PHSA”) (a “Biosimilar Application”) naming Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), such Party will, [***].: [***]
Appears in 1 contract
