Manufacturing Obligations. Licensee agrees that it will manufacture the Compound and Licensed Product in a manner consistent with (a) WHO Prequalification standards; or (b) the standards of any SRA. Licensee will manufacture and sell the Compound and Licensed Products in accordance with all laws and regulations relevant to the manufacture and sale of the Compound and Licensed Product, including cGMP, and in accordance with good industry practice. Licensee agrees that it: (a) subject to Section 3.8, will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA; and (b) will comply with applicable regulatory requirements in the country of manufacture and the country of sale.
Appears in 5 contracts
Samples: License Agreement, License Agreement, License Agreement
