Provision Language
3. Development and Registration
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3.7 Reports. During the period Licensee is developing the Licensed Products, Licensee will provide MPP with an annual report describing (a) the status of development of each Licensed Product in development (b) the regulatory filing plan with the WHO Pre-qualification Programme and/or a Stringent Regulatory Authority anticipated for each Licensed Product in the upcoming calendar year if one exists, and (c) a list of countries for which regulatory approvals or authorizations have been obtained during the reporting period for any Licensed Product. Such annual report shall be provided to MPP within sixty (60) days of the end of each calendar year. Following regulatory approval for any Licensed Product by the WHO Pre-qualification Programme and/or a Stringent Regulatory Authority, Licensee will send to MPP within thirty (30) days following the end of each Agreement Quarter a written report setting forth a list of countries for which regulatory approvals or authorizations have been obtained during the reporting period for any Licensed Product, as well a statement accounting for all Licensed Products (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under this Agreement during such Agreement Quarter. MPP agrees that information contained in these annual and quarterly reports shall be treated as Confidential Information.