Development and Commercialisation. 4.1 Within [***] days following the Effective Date, the Parties shall agree to a research and technical development plan (the “Research and Technical Development Plan”) that sets forth the Parties’ respective Research and Technical Development Plan Activities, which may be amended from time to time by the JDC in accordance with this Agreement. The Parties shall perform and complete, or cause the performance and completion of, their respective Research and Technical Development Plan Activities, and deliver to each other a summary of the results (including raw data if reasonably requested by a Party), samples and reports arising therefrom in accordance with each Research and Technical Development Plan within [***] ([***]) days following completion thereof. 4.2 The Licensee shall provide Ascendis with a draft of each Research and Technical Development Plan. The Licensee shall consider, in good faith, any comments regarding each draft Research and Technical Development Plan that Ascendis provides to the Licensee within [***] ([***]) days of Ascendis’ receipt of such draft Research and Technical Development Plan. In addition, the Licensee shall keep Ascendis informed of the progress of the development of each Licensed Product against the applicable Research and Technical Development Plan at each meeting of the JDC pursuant to Clause 4.6(A). 4.3 The Licensee shall be solely responsible for any clinical trial activities carried out as part of its development and commercialisation activities in the Territory. 4.4 The Licensee shall use Diligent Efforts to develop and commercialise Licensed Product in the Field in the Territory. 4.5 Each Party shall conduct all development of Licensed Product in compliance with current Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, in each case, where applicable. Neither Party shall use any person that has been debarred, disqualified or banned from practising medicine to perform activities under this Agreement, and each Party shall immediately notify the other Party in writing if any person performing activities under this Agreement is disqualified, debarred or banned from practising medicine.
Appears in 4 contracts
Samples: Exclusive Licence Agreement, Exclusive Licence Agreement (Ascendis Pharma a/S), Exclusive Licence Agreement (Ascendis Pharma a/S)
Development and Commercialisation. 4.1 Within [***] days following the Effective Date, the Parties shall agree to a research and technical development plan (the “Research and Technical Development Plan”) that sets forth the Parties’ respective Research and Technical Development Plan Activities, which may be amended from time to time by the JDC in accordance with this Agreement. The Parties shall perform and complete, or cause the performance and completion of, their respective Research and Technical Development Plan Activities, and deliver to each other a summary of the results (including raw data if reasonably requested by a Party), samples and reports arising therefrom in accordance with each Research and Technical Development Plan within [***] ([***]) days following completion thereof.
4.2 The Licensee shall provide Ascendis with a draft of each Research and Technical Development Plan. The Licensee shall consider, in good faith, any comments regarding each draft Research and Technical Development Plan that Ascendis provides to the Licensee within [***] ([***]) days of Ascendis’ receipt of such draft Research and Technical Development Plan. In addition, the Licensee shall keep Ascendis informed of the progress of the development of each Licensed Product against the applicable Research and Technical Development Plan at each meeting of the JDC pursuant to Clause 4.6(A).
4.3 The Licensee shall be solely responsible for any clinical trial activities carried out as part of its development and commercialisation activities in the Territory.
4.4 The Licensee shall use Diligent Efforts to develop and commercialise Licensed Product in the Field and/or Diabetic Retinopathy in the Territory, including, subject to Clause 5.1, using Diligent Efforts to commence Research and Technical Development Plans [***].
4.4 If the Licensee has not commenced Research and Technical Development Plans for [***] such Licensed Products within [***] and Ascendis has complied with Clause 5.1, then the licence granted to the Licensee under Clause 2.1(A) shall become non-exclusive in the Field, except that [***].
4.5 Each Party The Licensee shall conduct all development of Licensed Product in compliance with current Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, in each case, where applicable. Neither Party shall use any person that has been debarred, disqualified or banned from practising medicine to perform activities under this Agreement, and each Party shall immediately notify the other Party in writing if any person performing activities under this Agreement is disqualified, debarred or banned from practising medicine.
Appears in 2 contracts
Samples: Exclusive Licence Agreement (Ascendis Pharma a/S), Exclusive Licence Agreement (Ascendis Pharma a/S)