Commercial Drug Substance and Drug Product Supply. [[Aravive:Organization]] shall not be responsible for supplying Drug Substance or drug product to [[3D Medicines:Organization]] for commercial use. [[Aravive:Organization]] shall permit [[3D Medicines:Organization]] to negotiate and enter into with [[Aravive:Organization]]’s Third Party supplier of the applicable Drug Substance and drug product a separate agreement for the commercial supply of such Drug Substance and drug product for use in the [[3D Medicines:Organization]] Territory, and [[Aravive:Organization]] shall use Commercially Reasonable Efforts to facilitate the negotiations of such agreement.

Sourcing, Manufacturing and Supply of Bulk Drug Product. CCX shall be responsible for sourcing Components and API, and for the Manufacture and supply to VF of the Bulk Drug Product in a professional manner in full compliance with industry standard and that level of care and skill ordinarily exercised by other professional manufacturers in similar circumstances and in accordance with the Specifications, applicable laws, the Quality Agreement and the terms and conditions of this Agreement, pursuant to individual purchase orders placed by VF. CCX shall use and ensure that its CMO uses the necessary and appropriate machinery and equipment and its personnel shall be adequately selected, trained and monitored for manufacturing and supplying the Bulk Drug Products. In case of any intended change to the equipment used for Manufacturing, the change control process set forth in the Quality Agreement shall be followed. CCX shall provide VF with reasonable opportunities to review and provide comment upon any proposes CMO agreement(s) which CCX shall reasonably execute.

Clinical Drug Substance and Drug Product Supply. [[Aravive:Organization]] will supply [[3D Medicines:Organization]]’ clinical requirements of the applicable Drug Substance and drug product for clinical use in the [[3D Medicines:Organization]] Territory, at [[Aravive:Organization]]’s Manufacturing Cost plus a ​, under a separate agreement (“Clinical Supply Agreement”) to be entered into between the Parties within ​ following the Effective Date. The Clinical Supply Agreement shall contain commercially reasonable terms as may be agreed upon in good faith by the Parties. All clinical product shall be delivered ​ (INCOTERMS 2020) ​.

Issuance of Purchase Orders. Company shall submit a purchase order to Takeda for each purchase of Bulk Drug Product at least ​ in advance of the applicable delivery date. Bulk Drug Product will be ordered in number of batches. The purchase orders shall specify the dosage and the requested date of delivery.

Purchase Price. In consideration for Takeda’s agreement to supply Bulk Drug Product under this Agreement, Company shall pay Takeda the Purchase Price for each delivery of Bulk Drug Product set forth on Exhibit 2 of this Agreement.

Promptly after the First Amendment Effective Date, the Parties shall amend the Roche-Dermira Supply Agreement in the following regard:

The Parties agree to enter into this Agreement to ensure supply of Bulk Drug Product for commercialization of the Product (as defined in the License Agreement). Manufacturing and Supply of Bulk Drug Product for other purposes such us clinical trials, MAP programs or any other use beyond commercialization shall be agreed by the Parties on case by case basis and will be formalized in a separate agreement.

Bulk Drug Product Purchase and Supply. Subject to the terms and conditions set forth in this Agreement, Takeda shall supply to Company, and Company shall purchase from Takeda, Bulk Drug Product in the dosage form and as per quantities set forth in Exhibit 2 of this Agreement for Company’s use. Takeda has no obligation to supply Bulk Drug Product to Company in any form or quantity other than as expressly provided in this Agreement.

Bulk Drug Product Purchase and Supply. Subject to the terms and conditions set forth in this Agreement, Takeda shall supply to Company, and Company shall purchase from Takeda, Bulk Drug Product in the dosage form and as per quantities set forth in Exhibit 2 of this Agreement for Company’s use. Takeda has no obligation to supply Bulk Drug Product to Company in any form or quantity other than as expressly provided in this Agreement.

Purchase Price. In consideration for Takeda’s agreement to supply Bulk Drug Product under this Agreement, Company shall pay Takeda the Purchase Price for each delivery of Bulk Drug Product set forth on Exhibit 2 of this Agreement.