Common use of Development Updates Clause in Contracts

Development Updates. The Parties shall provide each other with quarterly written and oral updates regarding all ROW Development of the Licensed Product in the Field at each JPC and JSC meeting (and at least once every Calendar Quarter while such Development is ongoing) at a reasonable level of detail containing at a minimum all information generated as of the date of the report that is or would be required to be included in an IND (or foreign equivalent), MAA (including by way of example and not limitation: all information regarding the API Compound and formulated dosage form(s) of the Licensed Product in the Field and methods of manufacturing the same, analytical methods, batch records, pre-formulation studies, reports summarizing development pharmaceutics, vendor information, validation documentation, interim and final results from all preclinical and clinical studies, adverse event data, patent information, regulatory documentation and filings, regulatory correspondence and data from nonclinical studies), a summary of incurred and expected Development Expenses against the Development Budget, as well as high-level plans and objectives for the subsequent twelve (12) months.

Appears in 2 contracts

Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.), Development and Commercialization Agreement (Theravance Biopharma, Inc.)