New Product Application definition
Examples of New Product Application in a sentence
A second or a subsequent occurrence of the Phase II Milestone Event shall only give rise to an obligation upon Oragenics to make the payment to Intrexon under this Section 5.2(a)(i) if such respective second or subsequent occurrence of the Phase II Milestone Event occurs after the FDA has granted an approval to an FDA New Product Application for at least one Oragenics Product under the Program.
The Party that owns any IND or New Product Application shall be primarily responsible for conducting meetings and discussions with the Regulatory Authorities related to the Product, including in relation to any Development under way at the Closing Date including the Ongoing Pivotal Studies, provided that the other Party shall have the right to participate in such meetings and discussions, unless prohibited by such Regulatory Authorities.
GSK will provide the initial Regional Commercialisation Plans with respect to [***] to Genmab for informational purposes, to the extent such plans are completed, at the time of the first New Product Application for an Oncology Indication is filed with the FDA and approximately [***] prior to the projected date of First Commercial Sale of Product for [***].
Prior to that Party submitting any IND or New Product Application, the Parties shall [***] in preparing and reviewing such IND or New Product Application and its [***].
TenX shall grant Genmab and its Affiliates a free-of-charge right to reference and use and have full access to all regulatory documents relating to a Product, including any IND or New Product Application (and all chemistry, Manufacturing and controls information), and any supplements, amendments or updates to the foregoing, where such regulatory documents are Controlled by TenX, which relate to the Retained Field or could likely relate to the Retained Field.
A second or a subsequent occurrence of the Regulatory Approval Application Milestone Event shall only give rise to an obligation upon Oragenics to make the payment to Intrexon under this Section 5.2(a)(iii) if such respective second or subsequent occurrence of the Regulatory Approval Application Milestone Event occurs after the FDA has granted an approval to an FDA New Product Application for at least one Oragenics Product under the Program.
A second or a subsequent occurrence of the Phase IIb/III Milestone Event shall only give rise to an obligation upon Oragenics to make the payment to Intrexon under this Section 5.2(a)(ii) if such respective second or subsequent occurrence of the Phase IIb/III Milestone Event occurs after the FDA has granted an approval to an FDA New Product Application for at least one Oragenics Product under the Program.
For purposes of subsections (i) through (iv) above in this Section 5.2(a), a later Oragenics Product shall be deemed to be a “different” Oragenics Product from an earlier Oragenics Product (and thus trigger a subsequent occurrence of the respective milestone payment obligation under any one of subsections (i) through (iv)) if regulatory approval of the later Oragenics Products must be obtained from the FDA under a different FDA New Product Application than the earlier Oragenics Product.