Safety Stock. To ensure continuity of supply, a reasonable quantity of safety stock of the API will be held by [[Organization A:Organization]] at the Manufacturing Site (the “Safety Stock”). Client will pay to [[Organization A:Organization]] a reasonable fee for the storage of the Safety Stock as may be mutually agreed by the parties.

Safety Stock. West will procure and maintain for the manufacturing of the Product a safety stock of raw materials and other components required to be used by West for the manufacture of the Product and as necessary to satisfy the Master Production Plan and applicable binding purchase orders for the Product and avoid supply shortages. In addition, West will procure strategic supply for any raw materials that have a lead-time in excess of the binding period for a raw material that may be reasonably expected to be in short supply based on industry trends within the 24 month forecasted quantity. West will be responsible for the costs and expenses associated with such safety stock.

“Compound” means the chemical compound known as soticlestat or TAK-935/OV935, with ​, which is understood as of the Effective Date to be a modulator of the Program Target (the “Lead Compound”), and ​. For clarity, “Compound” includes any chemical compound with the chemical structure attached hereto as Exhibit A, ​.

Patient Safety. Practice Fusion shall review its policies and procedures, and where necessary implement enhanced policies and procedures, training, and processes, to ensure patient safety risks are identified and users appropriately and timely notified of patient safety issues, including by posting such issues and resolution specifics on Practice Fusion’s customer portal. Practice Fusion shall ensure adequate systems to detect, identify, and record potential issues impacting patient safety. Such issues, for example, could include # transmission, retention, or display of inaccurate prescriptions, incorrect drug, diagnoses, or lab codes in connection with medication lists, problem lists, labs or imaging, drug-drug or drug-allergy checks, ePrescriptions, or CCDAs, # incorrect patient information appearing within the records displayed to providers, or in visit summaries provided to patients, # failure to transmit or receive imaging or laboratory orders or results, # inaccurate imaging or laboratory orders or results, # drug database or medical vocabularies not being updated, # patient records and/or medical information appearing under the name of another patient.

Safety Notices. Within the past ​, neither any Credit Party nor any of its Subsidiaries has initiated or otherwise engaged in any recalls, field notifications, safety warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action, including as a result of any Risk Evaluation and Mitigation Strategy proposed or enforced by the FDA, relating to an alleged lack of safety or regulatory compliance of the Product that would reasonably be expected to result ​.

Safety Reasons. AzurRx shall have the right to terminate this Agreement immediately upon written notice to FWB if AzurRx reasonably determines based upon additional information that become available or an analysis of the existing information at any time that the medical risk/benefit of the Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize the Product.

“[[Adimab:Organization]] Materials” means any tangible biological or chemical materials (including all vectors, antibodies and other Know-How in the form of tangible biological or chemical materials) used or created by [[Adimab:Organization]] under a Research Program, including quantities of Program Antibodies (and DNA encoding these Program Antibodies), but excluding from and after the time of Option exercise for the relevant Target any quantities of Optioned Antibodies (and DNA encoding these Optioned Antibodies) provided to iTeos for such Target.

Safety Database. CANbridge will own the global safety database with respect to all Products. The Parties will cooperate with regard to the reporting and handling of safety information involving any Product in accordance with Applicable Laws and other regulations on pharmacovigilance and clinical safety.

In the event of a reasonable safety concern, United shall have the right, at its own cost, to inspect, review, and observe Contractor’s operations of Scheduled Flights. Notwithstanding the conduct or absence of any such review, Contractor is and shall remain solely responsible for the safe operation of its aircraft and the safe provision of Regional Airline Services, including all Scheduled Flights, in each case in accordance with the standards, agreements, representations and warranties set forth in Exhibit N. Contractor represents and warrants that it has successfully undergone an IATA Operational Safety Audit (“IOSA”). Contractor hereby covenants # to comply and maintain compliance with the requirements of such audits within the timeframe required by IATA and # maintain its membership in the IOSA registry. Any failure to maintain compliance shall immediately be brought to United’s attention along with corrective actions taken or a corrective action plan. Although the IOSA is to be completed biennially, United in its sole discretion may require, and Contractor shall comply with, additional safety review audits. Nothing in Exhibit N, this Section 4.9, or otherwise in this Agreement is intended or shall be interpreted to make United responsible for such safety matters.

Safety Stock. NOF shall maintain a safety stock of the ​ raw material in a quantity that is sufficient to Manufacture at least ​ of SUNBRIGHT ​ (the “Safety Stock”) from ​ and thereafter throughout the Term. This Safety Stock shall remain separate and distinct from any other quantities of ​ inventory held at NOF’s Facility and shall be stored by NOF. NOF will maintain the appropriate level of Safety Stock by promptly replenishing that quantity of ​ used in such supply in accordance with [Section 4.7]. NOF will manage Safety Stock to fulfill Apellis purchase orders on a routine basis to prevent units of ​ being held in the Safety Stock from exceeding their posted expiration date. NOF shall replenish its Safety Stock within ​ of use pursuant to this [Section 4.13] (the “Replenishment Period”). NOF shall within ​ of the end of the Replenishment Period notify Apellis in writing of its inability to replenish the Safety Stock as aforesaid. Upon expiration or earlier termination of this Agreement, Apellis shall purchase the Safety Stock in accordance with [Section 9.3].