Common use of Standard of Manufacturing Clause in Contracts

Standard of Manufacturing. Oculus warrants and represents that it shall Manufacture all Products in the Territory in compliance and accordance with the requirements of the appropriate Regulatory Authority to Manufacture drug products under cGMP conditions and in accordance with the Specifications and all applicable laws, and that each Product shall be free of manufacturing defects. Upon delivery of the Product, Oculus shall provide to Ruthigen all original batch records, reject samples, and relevant documents including but not limited to as required under cGMP for lot to lot traceability of materials, and a certificate of analysis confirming all Products meet the Specifications, and any additional information as reasonably requested by Ruthigen to allow it to comply with applicable laws, rules and regulations. Oculus shall notify Ruthigen and/or provide any information, including but not limited to any regulatory results or current Good Manufacturing Practices issues, within three (3) Business Days of discovering such information. Oculus shall promptly report any and all deviations during Manufacturing of Products to Ruthigen. All deviations, not limited to Specifications, Manufacturing, process, equipment and material controls shall require Ruthigen’s prior written approval. Ruthigen shall have the right, upon reasonable advance notice and during normal business hours, to make a representative or auditor available to observe the Manufacturing process and environment, Product storage conditions and related processes or documentation. Ruthigen will not be liable for payment for any Products which do not meet the requirements of this Agreement, which Products shall be promptly replaced by Oculus at its own expense or, if Oculus cannot promptly replace such Products, then Oculus shall immediately refund all amounts paid by Ruthigen in respect of such nonconforming Products.

Standard of Manufacturing. Oculus warrants and represents that it shall Manufacture all Products in the Territory in compliance and accordance with the requirements of the appropriate Regulatory Authority to Manufacture drug products under cGMP conditions and in accordance with the Specifications and all applicable laws, and that each Product shall be free of manufacturing defects. Upon delivery of the Product, Oculus shall provide to Ruthigen all original batch records, reject samples, and relevant documents including but not limited to as required under cGMP for lot to lot traceability of materials, and a certificate of analysis confirming all Products meet the Specifications, and any additional information as reasonably requested by Ruthigen to allow it to comply with applicable laws, rules and regulations. Oculus shall notify Ruthigen and/or provide any information, including but not limited to any regulatory results or current Good Manufacturing Practices issues, within three (3) Business Days of discovering such information. Oculus shall promptly report any and all deviations during Manufacturing of Products to Ruthigen. All deviations, not limited to Specifications, Manufacturing, process, equipment and material controls shall require Ruthigen’s prior written approval. Ruthigen shall have the right, upon reasonable advance notice and during normal business hours, to make a representative or auditor available to observe the Manufacturing process and environment, Product storage conditions and related processes or documentation. Ruthigen will not be liable for payment for any Products which do not meet the requirements of this Agreement, which Products shall be promptly replaced by Oculus at its own expense or, if Oculus cannot promptly replace such Products, then Oculus shall immediately refund all amounts paid by Ruthigen in respect of such nonconforming Products. * Portions of this exhibit, indicated by the xxxx “[ ]*,” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to an application requesting confidential treatment.