Supply of Licensed Product for Commercialization. Theravance shall be responsible, either directly or through Theravance’s vendors or contractors, for supplying at Clinigen’s expense formulated, packaged and labeled Licensed Product for Commercialization activities in the Territory or, at Clinigen’s request, unlabeled finished product for Clinigen to manage packaging and labeling within the Territory. Such formulated, packaged and labeled Licensed Product shall be manufactured and supplied in accordance with all applicable Laws and then current Good Manufacturing Practices. Clinigen will reimburse Theravance within thirty (30) days of receipt of itemized invoices for all of Theravance’s Fully Burdened Cost incurred after the Effective Date associated with supplying such formulated Licensed Product as mutually agreed by the Parties. A forecast for formulated, packaged and labeled Licensed Product requirements for Commercialization in the Territory shall be prepared and periodically updated by the Joint Steering Committee and coordinated with the applicable Marketing Plan for the Licensed Product. During the three (3) month period following the Effective Date, the Parties shall in good faith use Diligent Efforts to enter into a supply agreement to carry out the principles set forth in this Section 9.03 and to address manufacturing of the API Compound and the formulated Licensed Product, to comply with regulatory requirements for sale in the Territory.
Appears in 4 contracts
Samples: Commercialization Agreement, Commercialization Agreement (Theravance Biopharma, Inc.), Commercialization Agreement (Theravance Biopharma, Inc.)