NDA Transfer Clause Samples
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NDA Transfer. Within three (3) Business Days of Seller’s receipt of written notice from the FDA that the Product NDA has been approved, Seller will take all steps required under 21 C.F.R. 314.72 to assign and transfer all of Seller’s rights in the Product NDA to Purchaser and to notify the FDA of same. Prior to transfer and assignment of Seller’s rights in the Product NDA to Purchaser, Purchaser will be deemed to have a beneficial right and interest in and to such Transferred Asset to the extent contemplated herein, but legal title to such asset shall not be deemed to have been passed to Purchaser until the occurrence of such transfer and assignment. For the avoidance of doubt, for purposes of Seller’s representations and warranties and other obligations pursuant to this Agreement, the Product NDA shall not be deemed a Transferred Asset as of any date or time period prior to the assignment and transfer described in this Section 5.1.
NDA Transfer. 2.1 After the Effective Date, RTU shall cooperate with SPA for timely transfers to SPA of ownership and control of all regulatory approvals and files, owned by RTU as of the Effective Date, for the Licensed Product in the SPA Territory, at RTU’s expense, with the exception of the CMC matter to be retained by RTU.
2.2 RTU shall provide SPA with transitional services relating to the regulatory approvals, which shall consist of supporting SPA’s efforts to submit regulatory filings, reasonably requested by SPA in writing for a period of up to six (6) months after Effective Date, at SPA ‘s expense.
2.3 Prior to the Effective Date, RTU shall maintain the NDA of the Licensed Product at RTU’s expense and, as from the Effective Date, SPA shall maintain the NDA of the Licensed Product at SPA’s expense within the SPA Territory.
NDA Transfer. NDA ROFR.. ▇▇▇▇▇▇ hereby grants, during the Term, a right of first refusal to NIT to acquire any or all of Emmaus’ Rights to the NDA for the Product for use in the Territory (the “NDA Rights”) in the event that ▇▇▇▇▇▇ receives an offer from a third party to engage in a transaction that would result in the sale, transfer, assignment or other disposition of the NDA for the Product for use in the Territory (the “NDA Rights ROFR”). Upon receipt of any such offer, ▇▇▇▇▇▇ will promptly inform NIT of the material terms of such offer in writing, and NIT will have 30 days from its receipt of such notice (the “NDA Rights ROFR Notice”) to inform ▇▇▇▇▇▇ of its intent to either waive or exercise its NDA Rights ROFR, subject to agreement of the Parties on the terms of such acquisition, provided that such terms shall be on terms substantially similar to those set forth in the NDA Rights ROFR Notice. In the event that NIT exercises its NDA Rights ROFR, the Parties agree to negotiate in good faith to close the acquisition of the NDA Rights within 60 days from the date of NIT’s notice to ▇▇▇▇▇▇ of its intention to exercise the NDA Rights ROFR. In the event NIT fails to respond within such 30-day period or indicates its desire not to acquire the NDA Rights, or the Parties are unable to close such acquisition within the 60-day period, Emmaus may proceed with the proposed transaction with such third party at any time within six (6) months after ▇▇▇’s failure to respond, negative response or termination of negotiations. In the event that Emmaus has not closed the acquisition by such third party within such six-month period, on substantially the same other terms and conditions as contained in the NDA Rights ROFR Notice (or terms and conditions better for Emmaus, taken as a whole) Emmaus shall again provide NIT with the notice and offer set forth in this Section 11.0 prior to proceeding with the contemplated disposition of the NDA Rights or another disposition of the NDA Rights. For the avoidance of doubt, this Section 11.0 shall not apply to any Change of Control of Emmaus (as defined in Section 11.3) or any transaction in which the NDA is transferred as part of a sale of all or substantially all of Emmaus's assets or equity interests; provided that in any such transaction, the acquirer shall assume Emmaus's obligations under this Agreement.
NDA Transfer