Extension of Patent Term. If a Licensed Product is eligible for extending the term of any patent in the Patent Rights under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or any European, Japanese, or other foreign counterparts of this law, then Licensee shall take all necessary steps with the appropriate regulatory authorities to apply in a timely manner for such an extension of the term for such patent. For example, such application must be made to the USPTO within sixty (60) days after the US FDA approves a commercial marketing application for said Licensed Product. Licensee shall prepare and file all documents needed for the application; and Licensee shall take all reasonable actions as may be appropriate to further obtain patent term extension. Licensor shall cooperate and sign such documents as may be reasonably requested by Licensee for the application. Licensee shall keep Licensor informed as to Licensee’s efforts to prepare and file said application, including giving a written report within thirty (30) days after Licensee obtains the applicable marketing approval from the FDA (or foreign counterpart). If Licensee fails to make this required application, then Licensor shall have the option but not the obligation to do so; and if Licensor does elect to file the application, then Licensee shall cooperate and sign such documents as may be needed; and Licensee shall reimburse Licensor’s costs incurred for said application.
Appears in 2 contracts
Samples: Patent License Agreement (TFF Pharmaceuticals, Inc.), Patent License Agreement (TFF Pharmaceuticals, Inc.)
Extension of Patent Term. If a Licensed Product is eligible for extending the term of any patent in the Patent Rights under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or any European, Japanese, or other foreign counterparts of this law, then Licensee shall take all necessary steps with the appropriate regulatory authorities to apply in a timely manner for such an extension of the term for such patent. For example, such application must be made to the USPTO within sixty (60) days [**] after the US FDA approves a commercial marketing application for said Licensed Product. Licensee shall prepare and file all documents needed for the application; and Licensee shall take all reasonable actions as may be appropriate to further obtain patent term extension. Licensor shall cooperate and sign such documents as may be reasonably requested by Licensee for the application. Licensee shall keep Licensor informed as to Licensee’s efforts to prepare and file said application, including giving a written report within thirty (30) days [**] after Licensee obtains the applicable marketing approval from the FDA (or foreign counterpart). If Licensee fails to make this required application, then Licensor shall have the option but not the obligation to do so; and if Licensor does elect to file the application, then Licensee shall cooperate and sign such documents as may be needed; and Licensee shall reimburse Licensor’s costs incurred for said application.
Appears in 1 contract
Samples: Patent License Agreement (Aileron Therapeutics Inc)
Extension of Patent Term. If a Licensed Product is eligible for extending the term of any patent in the Patent Rights under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or any European, Japanese, or other foreign counterparts of this law, then Licensee shall take all necessary steps with the appropriate regulatory authorities to apply in a timely manner for such an extension of the term for such patent. For example, such application must be made to the USPTO within sixty (60) days after the US FDA approves a commercial marketing application for said Licensed Product. Licensee shall prepare and file all documents needed for the application; and Licensee shall take all reasonable actions as may be appropriate to further obtain patent term extension. Licensor shall cooperate and sign such documents as may be reasonably requested by Licensee for the application. Licensee shall keep Licensor informed as to Licensee’s efforts to prepare and file said application, including giving a written report within thirty (30) days after Licensee obtains the applicable marketing approval from the FDA (or foreign counterpart). If Licensee fails to make this required application, then Licensor shall have the option but not the obligation to do so; and if Licensor does elect to file the application, then Licensee shall cooperate and sign such documents as may be needed; and Licensee shall reimburse Licensor’s costs incurred for said application.. Licensee: TFF Pharmaceuticals, Inc. CONFIDENTIAL Amended and Restated Patent License Agreement
Appears in 1 contract
Samples: Patent License Agreement (TFF Pharmaceuticals, Inc.)