Examples of Product IND in a sentence
Within [***] days of the Effective Date, unless otherwise agreed by the Parties, Takeda will assign to Licensee all rights, title, and interests in and to each Licensed Product IND filed in the Field in the Licensee Territory, and will transfer to Licensee copies (in electronic or other format) of those Regulatory Materials owned by Takeda or its Affiliates as of the Effective Date that are necessary to assign such Licensed Product INDs to Licensee.
The parties shall take such additional actions, and execute and deliver, and file with the FDA, such additional documents, as are necessary to effect the transfer and assignment to Santarus of the Product NDA and Product IND contemplated by this paragraph.
As soon as practicable after the submission of such letter, Santarus shall execute and submit to the FDA a letter, accompanied by the Product NDA and Product IND transfer letter(s) referred to in the preceding sentence, acknowledging Santarus’ commitment to assume ownership of the Product NDA and Product IND.
If, after assignment to Santarus of the Product NDA and Product IND, the parties mutually and reasonably agree in good faith that the Product NDA or Product IND should be assigned back to Depomed, the parties shall promptly execute and deliver such documents and take such actions as are necessary to effect such assignment back to Depomed.
If there is any impediment to the assignment of the Product NDA or Product IND to Santarus, the parties shall cooperate in good faith and use commercially reasonable efforts to remove such impediment.