Development Program. (a) VIA shall, at its expense, conduct a clinical and commercial development program relating to the use of a Licensed Product using commercially reasonable efforts (“Development Program”) consistent with a Development Plan that is to be provided to Roche as soon as practicable after creation by VIA. VIA shall provide on a once yearly basis written reports to the Global Liaison on the progress of the Development Program, and annually shall provide to the Global Liaison a written overview of material Development Program activities. (b) VIA shall maintain a clinical trials database in accordance with the standards of Regulatory Agencies. (c) The Development Plan may be reasonably modified and updated at any time as is deemed necessary at the discretion of VIA. (d) Upon completion of a Phase I clinical trial for each Licensed Product, VIA shall present to Roche (i) a summary presentation of the data generated by such Phase I clinical trial, and (ii) a Development Plan for Phase II. (e) Notwithstanding anything to the contrary hereunder (including without limitation under Section 6.1 and this Section 6.2), VIA’s sole and exclusive liability and Roche’s sole and exclusive remedy for any failure by VIA to exercise any required level of efforts to research, develop, obtain Registrations or commercialize the Licensed Products shall be for Roche to exercise any termination right that Roche might have pursuant to Section 12.3 on account of such failure.
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Samples: Research, Development and Commercialization Agreement, Research and Development (Madrigal Pharmaceuticals, Inc.), Research, Development and Commercialization Agreement (Via Pharmaceuticals, Inc.)
Development Program. (a) VIA shall, at its expense, conduct a clinical and commercial development program relating to the use of a Licensed Product using commercially reasonable efforts (“Development Program”) consistent with a Development Plan that is to be provided to Roche as soon as practicable after creation by VIA. VIA shall provide on a once yearly basis written reports to the Global Liaison on the progress of the Development Program, and annually shall provide to the Global Liaison a written overview of material Development Program activities.
(b) VIA shall maintain a clinical trials database in accordance with the standards of Regulatory Agencies.
(c) The Development Plan may be reasonably modified and updated at any time as is deemed necessary at the discretion of VIA.
(d) Upon completion of a Phase I clinical trial for each Licensed Product, VIA shall present to Roche (i) a summary presentation of the data generated by such Phase I clinical trial, and (ii) a Development Plan for Phase II.
(e) Notwithstanding anything to the contrary hereunder (including without limitation under Section 6.1 and this Section 6.2), VIA’s sole and exclusive liability and Roche’s sole and exclusive remedy for any failure by VIA to exercise any required level of efforts to research, develop, obtain Registrations or commercialize the Licensed Products shall be for Roche to exercise any termination right that Roche might have pursuant to Section 12.3 on account of such failure.
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Via Pharmaceuticals, Inc.)