Quality. When requested by Buyer, Seller shall promptly submit real time production and process measurement and control data (the “Quality Data”) in the form and manner requested by Buyer. Seller shall provide and maintain on inspection, testing and process control system (“Seller’s Quality System”) covering the goods and services provided hereunder that is acceptable to Buyer and its customer and complies with Buyer’s quality policy and/or other quality requirements that are set forth on the face of this Order or are otherwise agreed to in writing by the parties (“Quality Requirements’’). Acceptance of Seller’s Quality System by Buyer shall not alter the obligations and liability of Seller under this Order. If Seller’s Quality System falls to comply with the terms of this Order, Buyer may require additional quality assurance measures at Seller’s expense. Such measures may include, but are not limited to, Buyer requiring Seller to install a Buyer-approved third party quality auditor(s)/inspector(s) at Seller’s facility(ies) to address the deficiencies in Seller’s Quality System or other measures that may be specified in Buyer’s Quality Requirements or otherwise agreed upon by the parties in writing. Seller shall keep complete records relating to Seller’s Quality System and shall make such records available to Buyer and its customer for: # three (3) year after completion of this Order; # such period as set forth in the specifications applicable to this Order: or # such period as required by applicable law, whichever period is the longest.

Quality Agreement. Within 120 days following the Effective Date, the Parties shall enter into a separate quality agreement that describes the responsibilities of each Party in the area of technical cooperation and quality assurance with respect to the supply of the Licensed Compound and Products for the Territory and containing terms and conditions customary for such agreements (the “Quality Agreement”).

Quality. Alba warrants that any Product sold to Ortho hereunder shall conform to the Specifications for such Product, comply with applicable law and regulations and the terms of this Agreement (including the Quality Agreement) and be free from defects in design, material and workmanship (“Product Requirements”). Any Product failing to meet the foregoing Product Requirements shall be considered “Defective Product”. Delivery of any Product by Alba to Ortho shall constitute a certification by Alba that the Product conforms to the foregoing requirements. Manufacturing and testing shall be performed as per applicable cGMPs. Mutual quality roles and responsibilities shall be defined in the Quality Agreement and each party shall fulfill such responsibilities. Alba represents and warrants to Ortho that neither Alba nor any of its employees have been “debarred” by the FDA, nor has Alba received notice that debarment proceedings have been commenced against Alba or any of its employees. Alba will immediately notify Ortho in writing if any such proceedings have commenced or if Alba or any of its employees are debarred by the FDA. Ortho may terminate this Agreement immediately upon receipt of any such notice from Alba.

Quality. Quality matters related to the Manufacture of the Compounds shall be governed by the terms of the Quality Agreement in addition to the relevant quality provisions of this Agreement.

Quality. The Parties agree that, following the Effective Date, they shall negotiate and enter into a separate Manufacturing Quality Agreement.

Quality Standard. The nature and quality of the Licensed Products shall conform to all specifications and standards of quality approved by Licensor pursuant to Section 6.3.

Quality. If the Parties have not executed a quality agreement governing the quality terms relating to supply of Bulk Drug Product under this Agreement (“Quality Agreement” ) contemporaneously with the execution of this Agreement, the Parties will execute a Quality Agreement within ​ after the Effective Date.

Quality. If the Parties have not executed a quality agreement governing the quality terms relating to supply of Bulk Drug Product under this Agreement (“Quality Agreement” ) contemporaneously with the execution of this Agreement, the Parties will execute a Quality Agreement within ​ after the Effective Date.

Quality. The Drug Substance Doses shall meet quality standards, which are to be determined in accordance with the provisions in [Section 6.5]. Arcturus shall supply the Bulk Drug Substance in accordance with such to be determined quality standards. Vinbiocare may reject each shipment of Bulk Drug Substance if such shipment does not comply with the to be determined quality standards.

Quality. Seller warrants that the Macadamia Kernel will be commercial (choice) grade or higher and will meet the specifications and requirements set forth on Exhibit B. Seller shall deliver a Certificate of Analysis to Buyer in the form attached hereto as Exhibit C with each container of Macadamia Kernel delivered to Buyer. Buyer may reject any container of Macadamia Kernel that does not meet the specifications and requirements contained in this Section 5 and in Exhibit B. Seller further warrants that it will comply with all applicable laws in Seller’s performance of this Agreement, including but not limited to the provisions of the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the pure food and drug laws and other present or future laws of the State of Hawaii. Other than as expressly stated in this agreement, seller makes no representations, guarantees or warranties, express or implied, of any kind. Without limiting the generality of the foregoing, seller expressly disclaims any warranty of merchantability, fitness, or suitability for a particular purpose or use notwithstanding any course of performance, usage of trade or lack thereof inconsistent with this section. Claims regarding the quality of the Macadamia Kernel shall be made by written notice from Buyer to Seller within ninety (90) days following delivery of the Macadamia Kernel to the Delivery Point. Any warranty claims regarding the quality not asserted within this time period shall be deemed to have been waived.