Favorable Resolution definition
Examples of Favorable Resolution in a sentence
Notwithstanding the foregoing, nothing herein shall constitute a guarantee or warranty from Seller that the ANDA for the Product will be approved by the FDA, or, if the Product ANDA is approved, any market exclusivity will be awarded, or any other regulatory approvals will be obtained by Seller or that a Favorable Resolution will be obtained.
In addition, Seller shall, at its expense, use Commercially Reasonable Efforts to obtain a Favorable Resolution to enable FDA approval of the Product’s ANDA and the launch of the Product in the Territory.
At any time after Seller receives both (i) a Favorable Resolution (which may, but is not required to be, a Final Favorable Resolution) and (ii) FDA approval of the Product’s ANDA and confirmation from the FDA that Seller has been awarded 180 days of “first to file” market exclusivity in accordance with Section 505(j)(5)(B)(iv) of the Act, Seller shall be entitled to deliver to Purchaser a written notice setting forth Seller’s intention to commence the commercial sale of the Product in the Territory.
Notwithstanding the foregoing, in the event that Seller receives FDA approval of the Product’s ANDA, but Seller is not awarded 180 days “first to file” market exclusivity and/or has not received a Favorable Resolution, Seller, at its option, may notify Purchaser of Seller’s desire to commence the commercial sale of the Product in the Territory.
Such written notice shall be referred to herein as an “At-Risk Launch Notice,” unless based on a Final Favorable Resolution, in which case such written notice shall be referred to herein as a “Non-At-Risk Launch Notice.” As used herein, a “Launch Notice” may refer generally to an At-Risk Launch Notice and/or a Non-At-Risk Launch Notice.
The joint instructions shall direct the Escrow Agent to (1) in the case of a Favorable Resolution, distribute the Dispute Amount to Seller, or (2) in the case of a Non-Favorable Resolution, return the Dispute Amount to Purchaser as a reduction to the Purchase Price, and to the extent such Outstanding Lease has been assigned to Purchaser, Purchaser shall assign such Outstanding Lease back to Seller and the Purchase Agreement shall be of no further force or effect with respect to such Outstanding Lease.
In addition, Seller shall, at its expense, use Commercially Reasonable Efforts to obtain a Favorable Resolution to enable FDA approval of the Product's ANDA and the launch of the Product in the Territory.
Any such disbursement of a Dispute Amount to Purchaser shall reduce the Purchase Price, and Purchaser shall assign back to Seller any Outstanding Lease(s) for which a Dispute has not had a Favorable Resolution, and the Purchase Agreement shall be of no further force or effect with respect to such Outstanding Lease(s).
Notwithstanding the foregoing, in the event that Seller receives FDA approval of the Product's ANDA, but Seller is not awarded 180 days "first to file" market exclusivity and/or has not received a Favorable Resolution, Seller, at its option, may notify Purchaser of Seller's desire to commence the commercial sale of the Product in the Territory.
Such written notice shall be referred to herein as an "At-Risk Launch Notice," unless based on a Final Favorable Resolution, in which case such written notice shall be referred to herein as a "Non-At-Risk Launch Notice." As used herein, a "Launch Notice" may refer generally to an At-Risk Launch Notice and/or a Non-At-Risk Launch Notice.