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HomeMy WebLinkAboutAgreement - State of California Department of Public Health - Signed 2026-04-16 1 Confidential - Low MEMORANDUM OF AGREEMENT BETWEEN THE STATE OF CALIFORNIA DEPARTMENT OF PUBLIC HEALTH and ___________________________________ (CHEMPACK CACHE LOCATION) I. Purpose To effectively respond to a Public Health nerve agent poisoning event(s), the Secretary of Health and Human Services (HHS) Office of the Administration for Strategic Preparedness and Response (ASPR) in coordination with the California Department of Public Health (CDPH), agrees to pre-position CHEMPACK Assets in Project Area ("RECIPIENT"). CDPH and the RECIPIENT (collectively, the "parties") agree to the terms, conditions, and responsibilities contained in this Memorandum of Agreement (MOA). This MOA is independent of, and supplements, any agreement between ASPR and RECIPIENT concerning the Strategic National Stockpile (SNS) but supersedes any previous agreements concerning CHEMPACK Assets. II. Parties The parties to this MOA are the California Department of Public Health (CDPH) and _________________________________________________________________ (CHEMPACK CACHE LOCATION) III. Incorporation by Reference The CDPH MOA with the HHS ASPR is incorporated by reference and made part of this MOA. IV. Definitions Cache Location – a facility that stores CHEMPACK Containers. CHEMPACK Assets – items listed in Attachment A or their approved pharmaceutical alternatives and/or therapeutic equivalents. Appendix I product content is subject to change, however a written revision to the MOA will not be required and an update to Appendix I will be provided. CHEMPACK Containers – Drug Enforcement Agency (DEA)-approved, self-monitoring, SATCO® units containing CHEMPACK Assets, padlock, CHEMPACK-serial-numbered container seal, and a temperature and security monitoring device. Drop Ship – Shipping of CHEMPACK products from SNS repositories directly to a CHEMPACK cache site and return shipment via mail using a contracted transportation carrier. This involves CHEMPACK cache site personnel or other RECIPIENT representative(s) coordinating the delivery, receipt, replacement, return shipment of product(s) and completion of all required documentation. The cost to implement Drop Ship City of Gilroy City of Gilroy Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 2 Confidential - Low will be the responsibility of ASPR. Extended Not Relabeled (ENR) – Product that has been tested through the Shelf-Life Extension Program (SLEP) and extended by the Food and Drug Administration (FDA) for use beyond the manufacturer’s original expiration date; however, product labeling will not reflect the new extension date. V. Responsibilities A. Prior to receipt of CHEMPACK Containers and CHEMPACK Assets, RECIPIENT will develop and provide to CDPH an operational plan for storage, monitoring, deployment, use, and administration of CHEMPACK Assets, which will address asset placement, distribution, coverage areas, and security. As part of RECIPIENT’s plan, or in another format approved by CDPH, RECIPIENT will provide CDPH the name, title/position, office phone number, cellphone number, and e-mail address(es), for a primary and alternate point of contact for each cache location. In addition, RECIPIENT will provide CDPH and ASPR with a list of all personnel, including name, title/position, primary phone number, and alternate phone number, who have access to CHEMPACK Containers and CHEMPACK Assets. RECIPIENT will notify CDPH of any changes in the plan or personnel and will provide updated plan and contact information within 48 hours of the change. Upon receiving ASPR’s approval of RECIPIENT’s operational plan, RECIPIENT will coordinate with CDPH for the transportation and delivery of CHEMPACK Container. The cache site/project area will be responsible for all costs associated with the storage of CHEMPACK Container(s). B. RECIPIENT will maintain CHEMPACK Containers as described in Attachment C. RECIPIENT will contact CDPH as soon as possible after detecting any non-compliant condition but no later than one hour after detecting a non-compliant deviation of climate control. RECIPIENT will begin to correct any non-compliant condition immediately upon discovery, and for any condition that cannot be corrected within 12 hours, RECIPIENT will coordinate with CDPH to move affected CHEMPACK Containers to a mutually acceptable location. RECIPIENT will report any loss or compromise of cache locations, CHEMPACK Containers, or CHEMPACK Assets immediately upon discovery, and will report within 48 hours the circumstances resulting in the loss or compromise, the nature of the loss or compromise, and the types and amounts of any CHEMPACK Containers or assets lost, compromised, or destroyed. C. RECIPIENT will maintain the integrity of the CHEMPACK Container seal until authorized state or local officials determine that deployment to respond to a nerve agent release is warranted OR to prevent the potential loss of life. RECIPIENT may deploy CHEMPACK Assets in response to an actual or suspected nerve agent event that: (1) threatens the medical security of the community; and (2) is beyond local emergency response capabilities; and (3) the CHEMPACK antidote is medically necessary to save a human life. RECIPIENT will notify CDPH within 24 to 48 hours of a deployment and report the type(s) and amount of CHEMPACK Assets: (1) used in the deployment; and (2) remaining in the CHEMPACK Container. Cache site will reseal the container following an inventory coordinated by the RECIPIENT. D. RECIPIENT will maintain the integrity of product cases and manufacturer labels for CHEMPACK products stored in CHEMPACK Containers. Labels will not be defaced or Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 3 Confidential - Low covered. Products will remain in their original manufacturer packaging/cases. E. RECIPIENT may temporarily transport CHEMPACK Containers for federally designated special events (i.e., National Special Security events, Super Bowl, World Series, major political conventions, state fairs, large scale or high-risk public events, etc.) for the purpose of strategically pre-positioning CHEMPACK Containers, subject to the following conditions: 1. RECIPIENT assumes responsibility for all costs associated with the transport of CHEMPACK Containers not specifically directed by the CHEMPACK Program; 2. RECIPIENT must notify CHEMPACK Program at least 48 hours prior to any movement; 3. RECIPIENT must notify CHEMPACK Program 30 days prior to non-emergency internal container moves to new cache storage area; 4. RECIPIENT's notification must be made via phone or email to the designated CDPH CHEMPACK Coordinator or CHEMPACK Regional Coordinator; 5. RECIPIENT will notify the DEA registrant of temporary or permanent container moves; 6. RECIPIENT must complete documentation provided by CHEMPACK for special events/temporary CHEMPACK Container moves; and 7. RECIPIENT must maintain CHEMPACK Container(s) and Assets during transport/storage to include the following: i. Secure temporary location by controlled access to include daily security checks. Each CHEMPACK Container should contain a lock with an ASPR-provided padlock and key access that is limited to personnel authorized by RECIPIENT's DEA-registrant and/or the Cache location pharmacy director. ii. Monitor and Control temperature at 68°F - 77°F (20°C - 25°C) to ensure temperatures are maintained during transport and at a temporary location, allowing for excursions between 59°F and 86°F (15°C and 30°C). Documentation required if temperature is not being monitored by a temperature monitoring device/system or disruption in system. iii. Ensure the integrity of the CHEMPACK Container(s) and CHEMPACK Assets are maintained according to regulation 21 CFR (i.e. sanitation, pest control, etc.). iv. Maintain fire detection and alarm systems, and fire suppression systems as required by federal, state, and local pharmaceutical regulations and fire codes. v. Store only ASPR-provided CHEMPACK Assets in CHEMPACK Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 4 Confidential - Low Container(s); storage of non-ASPR-provided assets in CHEMPACK Container(s), including state or locally owned nerve agent antidotes, is not permitted. Ensure no items are placed or stored on top of CHEMPACK Container(s) that exceed 100 pounds. F. Any movement of CHEMPACK Containers not described above in section (E) must be approved by CDPH and ASPR. G. Upon request from CHEMPACK Coordinators, RECIPIENT will provide access to RECIPIENT’s Cache Location to allow CHEMPACK Coordinators to perform: 1. Routine review of facilities holding CHEMPACK Assets and to inventory, restock, and remove expiring/expired CHEMPACK Assets; and 2. Periodic audits, including quality assurance and quality control inspections, to verify that RECIPIENT is complying with the terms and conditions of this MOA. H. CHEMPACK Coordinators and/or RECIPIENT will inventory CHEMPACK Containers approximately every 12 to 24 months or as required by CHEMPACK. I. RECIPIENT agrees to provide CHEMPACK Assets to patient(s) free-of-charge. J. Drop Ship CHEMPACK Assets: 1. RECIPIENT and CHEMPACK cache site personnel or their authorized representatives will accept the arranged delivery, conduct and verify product replacement, sign applicable documentation, and return such assets and records as outlined in the CHEMPACK Drop Ship: Receive and Return Instructions included in each shipment. 2. Expiring product from a Drop Ship will be returned to a Division of the Strategic National Stockpile (DSNS) warehouse within 10 business days of receipt of replacement product. If unable to return expiring product within recommended window contact CDPH CHEMPACK Coordinator for guidance. VI. Costs Except where otherwise described in this MOA, each party is responsible for its own costs. ASPR and CDPH are generally not funded to replace CHEMPACK Assets and CHEMPACK Containers lost, compromised, or destroyed, but may replenish or replace, or assist RECIPIENT in identifying and/or paying for potential mechanisms to replenish or replace, CHEMPACK Assets used in response to a nerve agent incident or as a result of circumstances beyond the reasonable control of the parties, i.e., natural disasters. VII. Ownership HHS retains ownership of all CHEMPACK Assets and CHEMPACK Containers, including after such Assets and Containers have been delivered to RECIPIENT and RECIPIENT Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 5 Confidential - Low has assumed custody. Appendix I product content is subject to change, however a revision to the MOA will not be required and an update to Appendix I will be provided. VIII. Compliance with US Drug Enforcement Agency Requirements A. RECIPIENT agrees to comply with all applicable federal, state, and local requirements regarding storage, use, and handling of controlled substances, including, but not limited to, those described in 21 CFR Parts 1301 and 1304. This also applies to the handling of controlled substances during temporary CHEMPACK Container moves. B. RECIPIENT must designate a pharmaceutical or medical professional with a DEA- registration who will sign for and accept custody for CHEMPACK Assets and who will be responsible for ensuring compliance with the terms and conditions of this MOA, including Appendix II. C. RECIPIENT will ensure that each CHEMPACK Cache Site possesses a valid, separate DEA registration. D. RECIPIENT will ensure a valid DEA registrant assumes custody of CHEMPACK controlled substances: Distributor, Hospital/Clinic, Emergency Medical Services and Retail Pharmacy. Practitioner registrations are not approved for use in the CHEMPACK Program. E. RECIPIENT must provide the DEA registrant's contact information (name, license number, primary and alternate phone number) four weeks prior to DSNS's schedule delivery of any CHEMPACK Assets. RECIPIENT will ensure that the DEA registrant or their designated representative will be present for all ASPR visits. IX. Requests for Information Under 42 USC § 247d-6b, federal agencies are prohibited from disclosing under the Freedom of Information Act (5USC § 552) any information identifying the location at which CHEMPACK Assets are stored. To the extent permitted by law, the parties agree that neither will disclose the nature of this effort or the terms of this MOA to any person or entity, except as may be necessary to fulfill their respective missions and statutory and regulatory responsibilities. The parties agree to notify one another before making any such disclosure. X. Settlement of Disputes The parties agree to consult with one another in good faith to resolve any disagreements that may arise from or relate to this MOA, before referring the matter to any other person or entity for settlement. XI. Liability Each party to this MOA shall be responsible for its own acts and omissions and those of its officers, employees, and agents. No party to this MOA shall be responsible for the acts or omissions of entities not a party to this MOA. Neither party to this MOA agrees to release, hold Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 6 Confidential - Low harmless, or indemnify the other party from liability that may arise or relate to this MOA. XII. No Private Right Created This document is an internal MOA between the parties and does not create or confer any right or benefit on any other person(s) or party, private or public. Nothing in this MOA is intended to restrict the authority of either signatory to act as provided by law or regulation, or to restrict any agency from enforcing any laws within its authority or jurisdiction. XIII. Authority, Effective Date, Modification and Termination This MOA shall become effective upon the signature of both parties and shall remain in effect until otherwise agreed to by the parties. The terms of this MOA may be modified upon written agreement by both parties. Either party may terminate this MOA at any time upon 180 days advance written notice unless there is a critical failure to perform. In the event of termination, all CHEMPACK Assets and Containers shall be returned to ASPR within 180 days of termination. If ASPR terminates this MOA for a reason other than RECIPIENT’S critical failure to perform, ASPR will, at its own cost, arrange for the return of the CHEMPACK Assets and Containers. The terms and conditions of this MOA will remain in effect until all CHEMPACK Assets and CHEMPACK Containers are returned. XIV. Capacity to Enter into Agreement The persons executing this MOA on behalf of their respective entities hereby represent and warrant that they have the right, power, legal capacity, and appropriate authority to enter into this agreement on behalf of the entity for which they sign. XV. Attachments A. LANGUAGE OF CDPH MOA WITH DSNS/ASPR B. CDPH CHEMPACK POINT OF CONTACT INFORMATION C. REQUIREMENTS FOR CHEMPACK CACHE LOCATION D. HCAI REQUIREMENTS FOR CHEMPACK LOCATIONS WITHIN HOSPITAL BUILDINGS Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 7 Confidential - Low _______________________________ __________________________________ Name: Tricia Blocher Name: Signing on behalf of California Signing on behalf of CHEMPACK Department of Public Health, CPR Cache Location: Deputy Director __________________________________ Title of Signatory Title of the Signatory _November 4, 2025______________ _________________________________ Date Signed Date Signed Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 4/14/2026 LeeAnn McPhillips Administrative Services & HR Director 4/14/2026 City Attorney Andy Faber City Administrator 4/16/2026 Matt Morley City Clerk 4/16/2026 Kim Mancera 8 Confidential - Low ATTACHMENT A MEMORANDUM OF AGREEMENT BETWEEN THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSE AND THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH I. PURPOSE To effectively respond to a Public Health nerve agent poisoning event(s), the Secretary of Health and Human Services (HHS) Office of the Administration for Strategic Preparedness and Response (ASPR) agrees to pre-position CHEMPACK Assets in Project Area ("RECIPIENT"). ASPR and the RECIPIENT (collectively, the "parties") agree to the terms, conditions, and responsibilities contained in this Memorandum of Agreement ("MOA"). This MOA is independent of, and supplements, any agreement between ASPR and RECIPIENT concerning the Strategic National Stockpile (SNS), but supersedes any previous agreements concerning CHEMPACK Assets. II.DEFINITIONS Cache Location – a facility that stores CHEMPACK Containers. CHEMPACK Assets – items listed in Appendix I or their approved pharmaceutical alternatives and/or therapeutic equivalents. Appendix I product content are subject to change, however a written revision to MOA will not be required and an update to Appendix I will be provided. CHEMPACK Containers – Drug Enforcement Agency (DEA)-approved, self-monitoring, SATCO® units containing CHEMPACK Assets, padlock, CHEMPACK-serial-numbered container seal, and a temperature and security monitoring device. Drop Ship – Shipping of CHEMPACK products from SNS repositories directly to a CHEMPACK cache site and return shipment via mail using a contracted transportation carrier. This involves CHEMPACK cache site personnel or other RECIPIENT representative(s) coordinating the delivery, receipt, replacement, return shipment of product(s) and completion of all required documentation. The cost to implement Drop Ship will be the responsibility of ASPR. Extended Not Relabeled (ENR) – Product that has been tested through the Shelf Life Extension Program (SLEP) and extended by Food and Drug Administration (FDA) for use beyond the manufacturer’s original expiration date; however, product labeling will not reflect the new extension date. III.RESPONSIBILITIES A. Prior to receipt of CHEMPACK Containers and CHEMPACK Assets, RECIPIENT will develop and provide to DSNS an operational plan for storage, monitoring, deployment, use, and administration of CHEMPACK Assets, which will address asset placement, distribution, coverage areas, and security. As part of RECIPIENT’s plan, or in another format approved by DSNS, RECIPIENT will provide DSNS the name, title/position, office phone number, cellphone number, and e-mail address(es), for: a primary and alternate statewide point of contact and a primary and alternate point of contact for each cache location. In addition, RECIPIENT will provide CHEMPACK Program with a list of all personnel, including name, title/position, primary phone number, and alternate phone number, who have access to CHEMPACK Containers and CHEMPACK Assets. RECIPIENT will notify CHEMPACK of any changes in the plan or personnel and will provide updated plan and contact information within 48 hours of the change. Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 9 Confidential - Low Upon receiving ASPR’s approval of RECIPIENT’s operational plan, the RECIPIENT will coordinate with 2 DSNS for the transportation and delivery of CHEMPACK Container. The cache site/project area will be responsible for all costs associated with the storage of CHEMPACK container(s). B. RECIPIENT will maintain CHEMPACK Containers as described in Appendix II. RECIPIENT will contact CHEMPACK Program as soon as possible after detecting any non-compliant condition but no later than one hour after detecting a non-compliant deviation of climate control. RECIPIENT will begin to correct any non-compliant condition immediately upon discovery, and for any condition that cannot be corrected within 12 hours, RECIPIENT will coordinate with CHEMPACK Program to move affected CHEMPACK Containers to a mutually acceptable location. RECIPIENT will report any loss or compromise of cache locations, CHEMPACK Containers, or CHEMPACK Assets immediately upon discovery, and will report within 48 hours the circumstances resulting in the loss or compromise, the nature of the loss or compromise, and the types and amounts of any CHEMPACK Containers or assets lost, compromised, or destroyed. C. RECIPIENT will maintain the integrity of the CHEMPACK Container seal until authorized state or local officials determine that deployment to respond to a nerve agent release is warranted OR to prevent the potential loss of life. RECIPIENT may deploy CHEMPACK Assets in response to actual or suspected nerve agent events that: (1) threaten the medical security of the community; (2) put multiple lives at risk; and (3) are beyond local emergency response capabilities. RECIPIENT will notify ASPR within 24 to 48 hours of a deployment and report the type(s) and amount of CHEMPACK Assets: (1) used in the deployment; and (2) remaining in the CHEMPACK Container. Cache site will reseal the container following an inventory coordinated by the RECIPIENT. D. RECIPIENT will maintain the integrity of product cases and manufacturer labels for CHEMPACK products stored in CHEMPACK Containers. Labels will not be defaced or covered. Products will remain in their original manufacturer packaging/cases. E. RECIPIENT may temporarily transport CHEMPACK Containers for federally designated special events (i.e., National Special Security events, Super Bowl, World Series, major political conventions, state fair, and large scale or high-risk public event etc.) for the purpose of strategically pre-positioning CHEMPACK Containers, subject to the following conditions: 1. RECIPIENT assumes responsibility for all costs associated with transport of CHEMPACK Containers not specifically directed by the CHEMPACK Program; 2. RECIPIENT must notify CHEMPACK Program at least 48 hours prior to any movement; 3. RECIPIENT must notify CHEMPACK Program 30 days prior to non-emergency internal container moves to new cache storage area; 4. RECIPIENT's notification must be made via phone or email to the designated CHEMPACK Regional Coordinator, CHEMPACK Operations Manager, or the CHEMPACK Section Lead; 5. RECIPIENT will notify the DEA registrant of temporary or permanent container moves; 6. RECIPIENT must complete documentation provided by CHEMPACK for special events/temporary CHEMPACK Container moves; 7. RECIPIENT must maintain CHEMPACK Container(s) and Assets during transport/storage to include the following: Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 10 Confidential - Low i. Secure temporary location by controlled access to include daily security checks. Each CHEMPACK Container should contain a lock with an ASPR-provided padlock and key access that is limited to personnel authorized by RECIPIENT's DEA-registrant and/or the Cache location pharmacy director. ii. Monitor and Control temperature at (68°F - 77°F) (20°C - 25°C) to ensure temperatures are maintained during transport and at a temporary location. Documentation required if temperature is not being monitored by a temperature monitoring device/system or disruption in system. iii. Ensure the integrity of the CHEMPACK Container(s) and CHEMPACK assets are maintained according to regulation 21 CFR (i.e. sanitation, pest control, etc.) iv. Maintain fire detection and alarm systems, and fire suppression systems as required by federal, state, and local pharmaceutical regulations and fire codes. v. Store only ASPR-provided CHEMPACK Assets in CHEMPACK Container(s); storage of non- ASPR-provided assets in CHEMPACK Container(s), including state-owned nerve agent antidotes, is not permitted. Ensure no items are placed or stored on top of CHEMPACK Container(s) that exceed 100 pounds. F. Any movement of CHEMPACK Containers not described above in section III (E) must be approved by ASPR. G. Upon request from CHEMPACK, RECIPIENT will provide access to RECIPIENT’s Cache Location to allow CHEMPACK to perform: 1. Routine review of facilities holding CHEMPACK Assets and to inventory, restock, and remove expiring/expired CHEMPACK Assets; and 2. Periodic audits, including quality assurance and quality control inspections, to verify that the RECIPIENT is complying with the terms and conditions of this MOA. H. CHEMPACK and/or RECIPIENT will inventory CHEMPACK Containers approximately every 12 to 24 months or as required by CHEMPACK. I. RECIPIENT agrees to provide CHEMPACK Assets to patient(s) free-of-charge. J. Drop Ship of CHEMPACK Assets, RECIPIENT and CHEMPACK cache site personnel or their authorized representatives will accept the arranged delivery, conduct and verify product replacement, sign applicable documentation, and return such assets and records as outlined in the “CHEMPACK Drop Ship: Receive and Return Instructions” included in each shipment. K. Expiring product from a Drop Ship will be returned to a DSNS warehouse within 10 business days of receipt of replacement product. If, unable to return expiring product within recommended window contact CHEMPACK Regional Coordinator for guidance. IV. COSTS Except where otherwise described in this MOA, each party is responsible for its own costs. ASPR's responsibilities are subject to the availability of appropriated funds. ASPR is generally not funded to replace CHEMPACK Assets and CHEMPACK Containers lost, compromised, or destroyed, but may replenish or replace, or assist RECIPIENT in identifying and/or paying for Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 11 Confidential - Low potential mechanisms to replenish or replace, CHEMPACK Assets used in response to a nerve agent incident or as a result of circumstances beyond the reasonable control of the parties, i.e., natural disasters. V. OWNERSHIP HHS retains ownership of all CHEMPACK Assets and CHEMPACK Containers, including after such Assets and Containers have been delivered to RECIPIENT and RECIPIENT has assumed custody. Appendix I product content are subject to change, however a revision to MOA will not be required and an update to Appendix I will be provided. VI.COMPLIANCE WITH US DRUG ENFORCEMENT AGENCY REQUIREMENTS A. RECIPIENT agrees to comply with all applicable federal, state, and local requirements regarding storage, use, and handling of controlled substances, including, but not limited to, those described in 21 CFR Parts 1301 and 1304. (This also applies to the handling of controlled substances during temporary CHEMPACK container moves). B. RECIPIENT must designate a pharmaceutical or medical professional with a DEA- registration who will sign for and accept custody for CHEMPACK Assets and who will be responsible for ensuring compliance with the terms and conditions of this MOA including Appendix II. C.RECIPIENT will ensure that each CHEMPACK Cache Site possesses a valid, separate DEA registration. D.RECIPIENT will ensure a valid DEA registrant assumes custody of CHEMPACK controlled substances: Distributor, Hospital/Clinic, Emergency Medical Services and Retail Pharmacy. Practitioner registrations are not approved for use in the CHEMPACK program. E. RECIPIENT must provide the DEA registrant's contact information (name, license number, primary and alternate phone number) four weeks prior to DSNS's schedule delivery of any CHEMPACK Assets. RECIPIENT will ensure that the DEA registrant or their designated representative will be present for all ASPR visits. VII.REQUESTS FOR INFORMATION Under 42 USC § 247d-6b, federal agencies are prohibited from disclosing under the Freedom of Information Act (5USC § 552) any information identifying the location at which CHEMPACK Assets are stored. To the extent permitted by law, the parties agree that neither will disclose the nature of this effort or the terms of this MOA to any person or entity, except as may be necessary to fulfill their respective missions and statutory and regulatory responsibilities. The parties agree to notify one another before making any such disclosure. VIII.LIABILITY Each party to this MOA shall be responsible for its own acts and omissions and those of its officers, employees, and agents. No party to this MOA shall be responsible for the acts or omissions of entities not a party to this MOA. Neither party to this MOA agrees to release, hold harmless, or indemnify the other party from liability that may arise or relate to this MOA. Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 12 Confidential - Low IX.NO PRIVATE RIGHT CREATED This document is an internal MOA between the parties and does not create or confer any right or benefit on any other person(s) or party, private or public. Nothing in this MOA is intended to restrict the authority of either signatory to act as provided by law or regulation, or to restrict any agency from enforcing any laws within its authority or jurisdiction. X.SETTLEMENT OF DISPUTES The parties agree to good faith consultation with one another to resolve disagreements that may arise under or relating to this MOA before referring the matter to any other person or entity for settlement. XI.AUTHORITY, EFFECTIVE DATE, MODIFICATION, AND TERMINATION A. This MOA is made under the authority of section 319F-2 of the Public Health Service Act, as amended (42 USC §247d-6b). B. This MOA shall become effective upon the signature of both parties and shall remain in effect until otherwise agreed to by the parties. The terms of this MOA may be modified upon written agreement by both parties. Either party may terminate this MOA at any time upon 180 days advance written notice unless there is a critical failure to perform. In the event of termination, all CHEMPACK Assets and Containers shall be returned to the ASPR within 180 days of termination. If ASPR terminates this MOA for a reason other than RECIPIENT’S critical failure to perform, ASPR will, at its own cost, arrange for the return of the CHEMPACK Assets and Containers. The terms and conditions of this MOA will remain in effect until all CHEMPACK Assets and CHEMPACK Containers are returned. XII.CAPACITY TO ENTER AGREEMENT The persons executing this MOA on behalf of their respective entities hereby represent and warrant that they have the right, power, legal capacity, and appropriate authority to enter into this MOA on behalf of the entity for which they sign. Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 13 Confidential - Low APPENDIX I Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 14 Confidential - Low Attach men t B California Department of Public Health (CDPH) Center for Preparedness and Response (CPR) Point of Contact Information CDPH CPR Du ty Officer Cel l Ph on e: 916-328-3605 Work/Mobile 6-208-7058 Work /Mobile: 916-439-5199 Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 15 Confidential - Low Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 16 Confidential - Low ATTACHMENT C REQUIREMENTS FOR CHEMPACK CACHE LOCATION Thank you for your interest in participating in the CHEMPACK Project as a CHEMPACK Cache Location. The CHEMPACK Project as part of the Strategic National Stockpile (SNS) program is designed to quickly mobilize resources to minimize and neutralize the effect of an attack (or large-scale exposure) involving chemical nerve agents. To accomplish this goal, CHEMPACK containers are strategically positioned throughout the country. The location of each CHEMPACK is a decision made by each County Operational Area. Your community has determined that a CHEMPACK is critical to the success of this extremely important project. CHEMPACK containers are available in two variations of pharmaceutical kits or containers. Each EMS CHEMPACK container will provide approximately 454 doses. Each Hospital CHEMPACK container will provide approximately 1000 doses. • Hospital containers are designed for hospital use. The nerve agent antidotes are primarily packaged in multi-dose vials to allow medical professionals to better control the dosage for follow-up and long-term care and will assist with precise dosing. • EMS containers are designed for initial use by emergency responders. The antidotes are packaged primarily in single-use auto-injectors. A percentage of the doses are designed for pediatric patients. Containers must be located in an area of suitable size, designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space and security conditions for storage of pharmaceuticals. Specifically, cache locations must meet the following federal requirements: 1. Accessibility: The location must be accessible to 20-foot or larger trucks and emergency response vehicles. Each location should have a method for unloading the containers: loading docks, ramps, or forklifts are appropriate. The containers are on wheels; however, they are very heavy and can weigh over 700 pounds. A freight elevator may be necessary if the location is upstairs. 2. Space: Each container location must have a minimum of 40 square feet per container. The Dimensions are 60.5" H, 32.S"W, 60.S"L. 3. Temperature/Environmental: The current USP definition of "controlled room temperature (CRT)" that encompasses the usual and customary working Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 17 Confidential - Low environment is 20°C to 25°C (68°F to 77°F); that results in a mean kinetic temperature (MKT) calculated to be not more than 25°C (77°F); and that allows for excursions between 15°C and 30°C (59°F and 86°F). Humidity levels must be maintained below 60% in accordance with Title 21, Code of Federal Regulations, Parts 205 and 211. CHEMPACK staff recommends a thermostat lock or other system to prevent tampering. The containers are equipped for wireless monitoring and will automatically alert ASPR of noncompliance with temperature, humidity or security requirements. The room must be designed to prevent the entry of rodents and/or vermin into the container storage area. Humidity must be maintained below 60% to prevent visible mold growth. Storage locations should be away from employee break areas where eating, drinking and smoking may create unsanitary conditions. 4. Electrical Power: A standard 120 VAC, 60Hz, 10W, UL-listed power supply is required. Each location must have automatic, 12-hour minimum back up or emergency electrical power. An uninterrupted power source (UPS) is minimally acceptable as a backup power source. Locations equipped with back-up generators capable of maintaining temperature in the event of a power outage are preferred as container sites. 5. Fire Suppression: Each container location must have a fire suppression system. Automatic sprinklers are recommended but not required. 6. Monitoring: Container locations must be physically checked monthly for continued compliance with all the above requirements. 7. Environmental Response: Institution personnel must be available to respond to emergency environmental alarms or conditions within one hour from notification. 8. Security: Security is a critical issue; pilferage and unauthorized access to pharmaceuticals is illegal and may substantially increase the cost of the CHEMPACK program and potentially negate its utility. Diazepam, a schedule IV-controlled substance, particularly presents a security concern. CHEMPACK Containers have LEXAN® Plexiglas walls lined with a hardened wire mesh to conform to FDA and DEA storage requirements for schedule IV-controlled substances. However, the facility, or at least the CHEMPACK storage room, must have controlled access. Additionally, container locations must have: a. Alarms and Monitoring: Container locations without physical monitoring on a continuous basis (24 hours a day, 7 days a week) must have a security system. Motion detectors, contact sensors or other types of security systems may be used, but the systems must be monitored at all times (24 hours a day, 7 days a week) and have notification abilities to contact designated responders should there be an attempted break into a container location. b. Security Response: Container locations must have staff members designated to respond to any security alarm. The CHEMPACK Project at Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 18 Confidential - Low CDPH/CPR must have current security contact information for all container locations. 9. SNS Notification: The containers have a wireless monitoring system attached that report directly to the SNS program at ASPR. Therefore, they should receive an alarm when a container is opened. Container locations must contact CHEMPACK Project personnel at CDPH/CPR as soon as possible when a container has been opened or compromised. 10. Technical Assistance: The CHEMPACK Project at CDPH/CPR is committed to facilitating the implementation of this program in participating hospitals. A minimal amount of funding has been dedicated to cover reasonable retrofit expenses and assistance in site planning is readily available from the CHEMPACK Project staff at CDPH/CPR. Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 19 Confidential - Low ATTACHMENT D HCAI REQUIREMENTS FOR CHEMPACK LOCATIONS WITHIN HOSPITAL BUILDINGS The California Department of Health Care Access and Information (HCAI) * regulates the construction and alteration of health facilities. When construction work is proposed to accommodate a CHEMPACK container, plans showing the work shall be submitted to HCAI for review and approval prior to the beginning of construction. Most CHEMPACK container installation projects in hospital buildings will require only minor construction work. Due to the limited scope of the modifications needed to accommodate a CHEMPACK location, it is anticipated that most, if not all, projects can be field reviewed. For field review, the plans, along with an Application for Plan Review may be submitted to the HCAI Regional Compliance Officer (RCO). Contact the HCAI RCO for plan review submittal requirements, or with questions regarding the applicability of HCAI regulations. In order to expedite the review, projects for modifications to accommodate CHEMPACK containers should not be combined with other alterations. A Guide for Field Review (FR) Projects, Excluded (E) from OSHPD Plan Review, and Expedited Review (ER) may be found on the HCAI website. While HCAI has no specific requirements regarding the location of CHEMPACK containers within health facilities, any construction work or modification of the hospital building needed to accommodate a CHEMPACK location must be reviewed and approved by HCAI before construction begins. This work may include, but is not limited to, constructing rooms or enclosures for the containers, installing seismic restraints for the container, adding or relocating electrical or telephone outlets, installing security devices, modifying HVAC systems, or replacing door hardware. Because of the size of the CHEMPACK container, the California Building Code requires that the container be restrained to prevent excess movement during a seismic event. A suggested detail for restraining the container is shown below. This detail may be used for most typical installations; however, restraint for atypical installations may need to be designed by an engineer. Policy Intent Notice PIN 68 - Support and attachment requirements for fixed, interim, mobile, mobile and other temporary equipment can be found on the HCAI website. HCAI has no authority to verify that any requirements other than those found in the California Building Standards Code have been met regarding the location or physical requirements for a CHEMPACK container, HCAI will not review for compliance with ASPR or other requirements. For more information on construction or review requirements pertaining to the location of CHEMPACK containers in health facilities, contact the HCAI Regional Compliance Officer for the facility. Facility details can be found at Facility details can be found at Facility Detail - HCAI. Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5 20 Confidential - Low * Formerly the Office of Statewide Health Planning and Development (OSHPD) Unistrut P1000 with 2 - #10 SMS to each wall stud for 1,000 lbs) mid- height of CHEMPACK container bracket to strut with hex-head cap screw wall Docusign Envelope ID: 949E708F-C6F4-8E1F-8010-1208845596D5