36C24422Q1185_1.docx

36C24422Q1185 See attached document: 36C24422Q1185 RFQ signed.

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30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

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7. FOR SOLICITATION

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STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C244-22-AP-4864

642-22-3-315-0229 36C24422Q1185 08-26-2022 Justin Erdley | Justin.Erdley@va.gov 412-822-3772 09-01-2022

12PM

EDT

00244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh

PA

X 541511 $30 Million N/A X 3900 Woodland Avenue Philadelphia PA 19104

00244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center

PO Box 149971 Austin

TX

78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Brainlab Node Server IAW the Statement of Work, Schedule, and Delivery Quotes may be submitted on this form or the Vendor's own form. All quotes shall be submitted no later than 9/1/2022 12pm EST. Any questions shall be submitted no later than 5:00PM EST, 8/30/2022, in writing to Justin.Erdley@va.gov No phone calls will be accepted.

See CONTINUATION Page x X x Darlene Seminko Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C244 Darlene Seminko

Network Contracting Office 4

1010 Delafield Road Pittsburgh PA

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of Salient Characteristics of Brainlab Element Software Subscription A) Functions to be performed:

The Corporal Michael J. Crescenz VAMC has been a consistent regional and national leader in performing stereotactic Deep Brain Stimulation (DBS) surgeries for movement disorders both inside and outside the VA system. Over the years the indications for stereotactic procedures in general have grown beyond movement disorders, and the number of patients we can help with them has increased. For example, the field of epilepsy surgery has exploded in the last 5-10 years due to the availability of laser technology and implantable devices requiring stereotactic surgery. As an Epilepsy Center of Excellence, the neurosurgery service at the CMCVAMC is actively working to build the surgical epilepsy program to bring our Veterans the best care available. Further, our ability to treat cognitive and psychiatric disorders with DBS is rapidly becoming a reality---an area our own department under Dr. Robert Krouse, Dr. Isaac Chen and Dr. Casey Halpern is actively pursuing.

In part due to the increased demand for stereotactic surgery, the technology for performing these procedures has also significantly advanced. There are numerous tools available in the operating room for precise placement of electrodes, laser fibers, or other implantable devices. Depending on the type of procedure needed and the specific needs of the patient, we may require different types of stereotactic targeting tools. A key technology required for any stereotactic procedure is sophisticated software that allows the surgeon to plan the surgery ahead of time, combining numerous imaging modalities and target selection to generate safe trajectories through the patient’s brain to achieve the surgical goal. Currently, the only planning software we have at the VA is integrated with the Stealth Station System and must be executed on either the intraoperative Stealth station in the OR, or on a single planning station available in the office of one of our surgeons, which must then be transferred to the OR computer via printed CD. Furthermore, the Stealth system must then be used as the stereotactic tool in the OR. While the Stealth software and system is adequate for many procedures, it does not allow planning of surgeries that utilize other stereotactic platforms, many of which are more suitable for certain cases, such as laser ablations, stereoelectroencephalography (SEEG), or Responsive Neurostimulation, or more suitable for certain patients.

Stereotactic surgeries for movement disorders and epilepsy are becoming increasingly collaborative. Often it is extremely advantageous for collaborative neurologists and nurses to be able to see the location of implanted electrodes, or devices on the patient’s imaging in the post-operative period, or during pre-operative planning. Utilizing a planning system that runs from a central server and is accessible from any VA computer would greatly enhance this capability.

The various types of advanced imaging that can be used in planning stereotactic brain surgery are expanding and therefore require software that can integrate them appropriately. Our current Stealth planning software has significant limitations in this regard, particularly in the realm of patient-specific brain segmentation and DTI processing.

Therefore, as we expand our functional and stereotactic neurosurgical program at the CMCVAMC, we are in need of a more flexible and more sophisticated planning software package that can integrate with many stereotactic targeting platforms, allow collaboration among multiple individuals and provide robust image processing of advanced modalities.

B) Performance required:

· Neurosurgical capabilities would fully integrate and provide standardized care across all stereotactic procedures including both functional and radiation oncological procedures. This is the

Page 1 of Page 1 of only such software that covers such a wide range of procedures, which also includes tumor resection planning.

· Allows all stereotactic procedures to be planned on one software platform which can then be interfaced with any other stereotactic targeting tool in the operating room, including Stealth Vertek system, StarFix, Medtronic Autoguide, ROSA, ClearPoint, etc. This is the only planning software designed to offer this universal functionality.

· Software can be run on a central server and then accessed via a web application from any VA computer. This would significantly improve the efficiency of planning, ability to maintain historical plans and imaging in one location for quality improvement and research and improve resident teaching. In addition, this would allow easy collaboration with other providers involved in the patient’s care, but who are not surgeons, such as epilepsy and movement disorders neurologists, as well as DBS/other device programmers---an increasingly important aspect of functional neurosurgery.

· Software is provided on a subscription basis, thus ensuring access to the latest updates and features, essential for a field that is rapidly changing and improving.

· Automatic patient specific segmentation, 3D modeling, image fusion, and proprietary distortion correction software provide the most accurate patient mapping and visualization tools available from any software vendor. As the types of pre-operative images used for planning become more advanced and varied, it is essential that the software used to integrate and fuse them for surgical planning does so accurately. Further, the patient specific segmentation capabilities have been a long-stranding strength of this company not matched by other commercially-available products.

· Appreciation of the white matter pathways as they relate to stereotactic targets is becoming more and more important in DBS and other neuromodulation procedures. The automatic DTI processing and fiber tractography visualization capabilities of this software are outstanding and impossible to find in any other commercial platform that is as comprehensive and flexible as this one.

The combination of the above-mentioned features are unique to the BrainLab Elements software platform and would well-serve the needs of the Corporal Michael J. Crescenz VA Medical Center stereotactic and functional neurosurgery program.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS- 319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

NODE SERVER HARDWARE PACKAGE 10985 \F\ NODE SERVER HARDWARE\F\ Node Server 5.2 Hardware for server-based treatment planning. ? Hewlett Packard DL360 Gen10 server hardware ? Intelr Xeonr processor Gold 6246 (3.30 GHz ? 4.2 GHz) ? 96 GB RAM ? 960 GB available disk space on SSD RAID ? 4x 1GBE Quad port gigabit server network adapter ? 19" Rack mount kit (rack not included) with telescopic rails and cable management arm ? Microsoft Windows Server 2019 64-bit ? Note: Node Server Hardware is an application server. It is not intended to provide a solution for PACS, data backup or long term data storage CUSTOMER SITE PREREQUISITES ? 1 rack unit space (43.2mm x 900mm x 435mm height/length/width) in air-conditioned server room ? LAN connection with minimum 100Mbit/s bandwidth and less than 50 ms latency ? For wireless client connections: WLAN access point ? Data storage solution for long-term archiving SERVICE ? DMR (digital media retention) - SSD is customer property ? Brainlab Service article 85020-02 Extended / Renewed Warranty Node Server required 21308 \F\ EXTENDED BROWSERS COMPATIBILITY FOR NODE\F\ Web based connection to an Origin Server using any HTML5 capable browser additionally to Internet Explorer. Includes browsers running on Mac OS based computers. SERVICES ? Includes for the first year after initial installation related software updates and upgrades within terms of use. Additional service costs occur, if not installed remotely via Brainlab Connected Care ? From the second year on software related updates and upgrades as well as 24/7 hotline support are covered by a separate license support contract for each individual software and needs to be purchased separately for each software in the portfolio REQUIREMENTS ? ORIGIN DATA MANAGEMENT

LOCAL STOCK NUMBER: B10985

INTEGRATION OF ONE ADDITIONAL ARC/FRAME FOR ELEMENTS STEREOTAXY Software integration and support for one of the following additional Arc geometries. Elekta ? Vantage Coordinate Frame ? Coordinate Frame G Integra ? CRW-ASL ? Precision CRW Inomed ? ZD Arc

LOCAL STOCK NUMBER: 21378

ELEMENTS VIEWER SMART LAYOUT CRANIAL SUBSCRIPTION Intelligent, indication-specific Smart Views for cranial indications exploiting anatomical information from Anatomical Mapping ? Dedicated Smart Views for aneurysm, pituitary adenoma and brain tumor ? Decide on surgical approach based on multi-modal 3D visualization ? Indication-specific 3D visualization of relevant anatomical structures ? Interactive visualization of superficial veins of the brain and vessels surrounding tumor ? Automatic, region-of-interest specific 3D visualization of aneurysm and surrounding vessels ? Textbooklike visualization of anatomical structures ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26412

ELEMENTS FIBERTRACKING SUBSCRIPTION Fibertracking enables the processing of diffusion imaging, highlighting detailed information about eloquent white matter structures. ? Combined deterministic and dual-tensor tracking for visualization of relationship between lesions and white matter tracts ? Region-of-interest based tracking using built-in simple ROI Brush, semi-automatic (Elements SmartBrush) or automatic (Elements Anatomical Mapping) segmentations ? Individual combination of live tracking with static regions-of-interest to tune results ? User-defined and anatomy-specific tracking templates available ? Intuitive user interface for manual adjustment of tracking parameters and instant update of fiber tracking results ? Fully automated DICOM DTI Data Preprocessing including De-noising, Motion- and Eddy Current Correction ? Conversion of results into 3D objects for use with 3rd party RT applications (requires Elements DICOM RT EXPORT) ? Automatic calculation of colored fractional anisotropy (FA) and anisotropic diffusion coefficient (ADC) maps ? Support of DICOM DTI data from Siemens, Philips, GE and manufacturers using standard DICOM MR diffusion information (at least 6 and up to 256 directions)

LOCAL STOCK NUMBER: 26227

ELEMENTS TRAJECTORY PLANNING CRANIAL SUBSCRIPTION Planning of multiple trajectories for neurosurgical approaches ? Flexible 3D shapes for case-specific trajectory visualization (e.g. DBS leads, sEEG electrodes, shunts, biopsy needles etc.) ? Target and Entry can be displayed in DICOM image coordinates ? Apply safety margin around trajectories e.g. for BenGun approaches ? Verification of trajectories in Axial, Coronal, Sagittal, Probe's Eye and Inline reconstructions ? Fully integrated with Elements Cranial Distortion Correction, Basal Ganglia Segmentation, Fibertracking and Smartbrush ? Combined visualization of supplemental information such as Fibertracks, Nuclei and Leads ? Multiple view layouts for optimal interactive target, entry and trajectory planning ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26250

ELEMENTS STEREOTAXY SUBSCRIPTION With Elements Stereotaxy trajectories can be planned for both frame-based or non-frame based procedures. For frame-based stereotactic procedures Elements Stereotaxy includes both Localization (MRI and CT) and Arc-Coordinate Calculation modules for a variety of stereotactic frame systems. ? Requires ELEMENTS TRAJECTORY PLANNING CRANIAL ? Stereotactic localization of MR/CT images ? Intuitive definition of AC, PC and mid-sagittal-plane ? Definition of the trajectory (Target and Entry) in AC/PC relative Coordinates (Distances and Angles) ? Target and Entry displayed in AC/PC and DICOM image coordinates ? Multi-modal image based trajectory planning in stereotactically unlocalized images prior to surgery ? Supports various mounting orientations for supported frames(e.g. lateral-left, lateral-right, sagittal-anterior, sagittal-posterior) ? Automatic calculation & PDF print out of specific arc settings ? Planning of multiple trajectories for neurosurgical approaches ? Flexible 3D shapes for case-specific trajectory visualization (e.g. DBS leads, sEEG electrodes, shunts, biopsy needles etc.) ? Adjust the orientation of Boston Scientific directional leads ? Apply pre-defined Boston Scientific 3D lead templates Apply safety margin around trajectories e.g. for BenGun approaches ? Verification of trajectories in Axial, Coronal, Sagittal, Probe's Eye and Inline reconstructions ? Fully integrated with Elements Cranial Distortion Correction, Basal Ganglia Segmentation, Fibertracking and Smartbrush ? Combined visualization of supplemental information such as Fibertracks, Nuclei and Leads ? Precise distance measurement tool ? Multiple view layouts for optimal interactive target, entry and trajectory planning ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26347

ELEMENTS LEAD LOCALIZATION SUBSCRIPTION Elements Lead Localization allows for automatic localization of implanted leads in post-operative CT scans. ? Automatic detection of implanted leads in CT scans ? Manual editing of detected lead position ? Flexible 3D shapes for case-specific trajectory visualization (e.g. DBS leads, sEEG electrodes, shunts, biopsy needles etc.) ? Apply pre-defined Boston Scientific 3D lead templates to detected implants ? Adjust the orientation of Boston Scientific directional leads ? Verification of trajectories in Axial, Coronal, Sagittal, Probe's Eye and Inline reconstructions ? Fully integrated with Elements Cranial Distortion Correction, Basal Ganglia Segmentation, Fibertracking and Smartbrush ? Combined visualization of supplemental information such as Fibertracks, Nuclei and Leads ? Includes related software updates and upgrades within terms of use - additional service costs occur, if notinstalled remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided toBrainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over thecourse of the subscription period and compatibility of hardware with software might be affected. Brainlab shall notbe responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26338

ELEMENTS DICOM BURNED-IN EXPORT SUBSCRIPTION ? Segmented 3D objects are permanently added to MRI DICOM image data (burned-in) as contours or surface. ? DICOM compliant 3rd party applications are able to load these image series and use the burned-in 3D objects e.g. by using thresholding algorithms

LOCAL STOCK NUMBER: 26203

ELEMENTS SMARTBRUSH SUBSCRIPTION Quick and easy interactive 3D contouring tool for outlining of pathologies and anatomical structures in medical images ? Instant volume generation by outlining on just two orthogonal slices using multi-modal "Side by Side" or axial, coronal and sagittal view configurations ? Intelligent contour propagation with ambient edge detection supporting various CT, MR or PET sequence ? Slice-by-slice contour review incl. side-by-side view and measurement functions ? Fast contour adaptation using "SimpleBrush" or "SmartBrush" modes ? Threshold segmentation based on user-defined intensity values e.g. for vessels or burned-in objects ? Intuitive user interface with both mouse and touch control compatibility ? Automatic creation of "Volumetric Report" PDF files per object with representative screenshots and details on geometrical measurements like volume, RECIST and Macdonald criteria ? Expandable with SmartBrush Angio for neurovascular indications INCLUDED SERVICES: ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26200

ELEMENTS OBJECT MANIPULATION SUBSCRIPTION Object Manipulation is a versatile and streamlined toolbox in order to quickly review, manipulate and fine tune generated organ at risk structures. ? Optimized layout enables fast navigation and review of organs at risk ? Interactive 3D Smart Shaper ensures rapid optimization of contoured structures ? Smart RT structure type assignment ? Intuitive object creation tools allows Copy, Union, Subtraction and Intersection operations ? Safety margins can be easily added to objects ? Smooth creation of additional anatomical structures, based on ELEMENTS SEGMENTATION

LOCAL STOCK NUMBER: 21768

ELEMENTS SEGMENTATION BASAL GANGLIA SUBSCRIPTION Automatic MR-based segmentation of structures in the basal ganglia region ? Thorough Anatomical Mapping based on Synthetic Tissue Model ? Definition of Synthetic Tissue Model based on 7T MRI ? Automatic body part detection ? Customizable list of objects to be segmented depending on workflow and clinical protocol ? Immediate data processing upon patient selection configurable ? Teaching tool for visualization and identification of patient anatomy in diagnostic images ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26331

ELEMENTS SEGMENTATION CRANIAL SUBSCRIPTION Automatic segmentation of anatomical brain structures on MR- and CT- data sets ? Structures include, but are not limited to: Brainstem, Cerebrum, Chiasm, Geniculate Body, Optic Nerve, Optic Tract, Precentral Gyrus, Temporal Lobe, Ventricles ? Thorough Anatomical Mapping based on Synthetic Tissue Model ? Automatic body part detection ? Customizable list of objects to be segmented depending on workflow and clinical protocol ? Immediate data processing upon patient selection configurable ? Teaching tool for visualization and identification of patient anatomy in diagnostic images

LOCAL STOCK NUMBER: 26212

ELEMENTS DISTORTION CORRECTION CRANIAL SUBSCRIPTION Image Fusion with distortion correction possibilities for cranial MR data sets ? More accurate anatomical co-registrations through local deformations based on multi-ROI rigid fusions ? Adaptation of distorted MR against reference MR (e.g. DTI to T1) as well as MR to CT ? Generation of an adapted, artificial DICOM data set co-registered to the reference data set ? Automatic content update like objects and landmarks according to the new registration field ? Supports automatic and interactive segmentation on new data sets ? Direct comparison of distortion corrected with conventional results through toggling ? Colored deformation grid highlights local deformations for detailed inspection ? Amber-blue color overlay and spyglass functionality complement the verification tools

LOCAL STOCK NUMBER: 26220

ELEMENTS IMAGE FUSION SUBSCRIPTION ? Fast and precise fusion, based on mutual information algorithm enables to exploit all anatomical & functional data sets simultaneously ? Automatic fusion of numerous modalities including CT, MRI (T1, T2, FLAIR, MRA), PET, SPECT ? Automatic pair selection with instantaneous pre-alignment and fusion ? Possibility of manual fine-adjustments in all dimensions ? Definition of a "Region of Interest" in all dimensions to exclude areas from fusion ? Color overlay in amber-blue and Spyglass functionality for reviews ? Ability to fuse a series of image datasets from different modalities and points of time ? Compatible with datasets of various body regions ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26217

ELEMENTS VIEWER 3D SUBSCRIPTION Intuitive image viewing, manipulation and data enrichment software specifically developed for surgeons ? Instantaneous, high-quality 3D visualization for analysis by and increased diagnostic confidence of the surgeon. ? 3D volume rendering of CT, MR, PET, SPECT datasets, with presets for visualization of skin, bone, vessel, DRR and MIP ? Toggle functionality to select between default and anatomical-specific textures and view anatomical data based on personal preferences ? Manual or automatical alignment of ACS and 3D views along the Frankfurter horizontal plane ? Superimposition of 3D dataset visualization and surgical planning data (volume objects, trajectories and labeled points) ? 3D multi-planar reconstructions in multiple planes (axial, coronal, sagittal, oblique) ? Concurrent display of multiple medical image series with flexible hanging protocols ? Image annotations and measurement functions for distance, angles and circles ? Selection of region of interest to cut and zoom onto the relevant anatomical volume ? Crop functionality to cut viewing plane into 3D visualization along any freely definable direction ? Equipment removal functionality from 2D and 3D reconstructions for better anatomical viewing ? Includes related software updates and upgrades within terms of use - additional service costs occur, if not installed remotely via Brainlab Connected Care ? Includes 24 hours, 7 days a week phone support hotline operated by technical professionals ? Software subscriptions will automatically renew with extension by 12 months, unless written notice is provided to Brainlab at least 60 days before the expiration of the then current term ? With regular updates and upgrades of the software the technical requirements for the hardware might change over the course of the subscription period and compatibility of hardware with software might be affected. Brainlab shall not be responsible and/or liable if this requirement is not met

LOCAL STOCK NUMBER: 26388

ORIGIN DATA MANAGEMENT SUBSCRIPTION Brainlab Origin Operating System facilitates intelligent and automatic synchronization of data between platforms and offers easy access to all new software capabilities. Universal patient data management software, that allows for import of patient data in DICOM format on Brainlab- and 3rd Party systems. Easy and intuitive user interface for streamlined access to patient data and applications. 1. GENERIC ORIGIN FEATURES ? Full control with support of touch gesture interaction, as well as mouse and keyboard support ? Advanced data import & export features (PACS, USB, CD/DVD, Quentry and network folder) ? Support of various modalities including CT, MR, PET/SPECT, X-ray ? PACS access via DICOM "Query/Retrieve" and "Push" (compatible to all standard conform PACS systems) ? Receipt of data via DICOM "Push" and support of DICOM worklists ? Automatic content configuration of OR displays based on user pre-defined setups ? Optional HIS integration via HL7 interface (message types: SIU, ADT, ORM - requires Origin Integration of HIS) ? Intelligent export of screenshots (.png or DICOM) and video recordings (.mp4 or DICOM) via DICOM "C-Store" ? Advanced patient data management tools including new patient creation, merging and editing ? HIPAA-compliant feature set including authentication, accountability log and automatic log-off ? Easy to service through link to Brainlab remote support (Brainlab Connected Care) 2. ORIGIN SERVER SOFTWARE FEATURES When installed on Brainlab Node Server or compatible 3rd party servers, Origin Data Management includes Origin Server Software either for full planning or for image viewing workflows. It enables access to Brainlab applications from any desktop PC, laptop or tablet connected to the hospital network (LAN/ WLAN / Internet) either from inside or outside the hospital. ? Mac OS and iOS devices compatible ? Full SSL encryption through HTTPS for higher security ? Scalability through Server Clustering with Load Balancing (e.g. Monte Carlo advanced dose calculation ? Session Sharing and team planning functionality ? Fully web based image viewing workflow - no client installation or configuration required ? Single Sign On (SSO) and support for Invoke Image Display IHE profile ? Software License valid for users within one clinical institution, concurrent users licensing model ? Each license contains 1 concurrent session ? Available on Brainlab Node Server or Customer Server ? Allows remote access to all treatment planning applications

LOCAL STOCK NUMBER: 26201

INSTALLATION PLANNING SERVER Complete installation and acceptance of one Brainlab server: ? Server hardware assembly and software pre-installation off-site (applies to Brainlab supplied server hardware only) ? Server software installation, configuration and testing on-site ? Link to local network if required ? Test and verification of client connection and data transfer ? Verification of completeness and functionality of all software functions and components ? Includes installation, configuration & integration of Brainlab Origin operating system software on a 3rd party hardware or virtual machine on-site if required This article applies to the installation of a Brainlab Node Server as well as a Virtual Machine.

LOCAL STOCK NUMBER: 8100-07

INSTALLATION AND CONFIGURATION BRAINLAB CONNECTED CARE Brainlab Connected Care is an integral part of most Brainlab software and hardware solutions to optimize system availability and lower overall system lifetime cost, and is therefore installed and configured by default with every Brainlab system installation to facilitate: ? faster system defect diagnosis through remote monitoring ? instant downloading of log files for faster troubleshooting ? remote management of software/firmware versions ? remote deployment of new software and software updates ? generating historic performance data documentation reports helping to improve products throughout their lifecycle Brainlab Connected Care is a service built on PTC ThingWorx and hosted on Microsoft Azure servers. Combining the power of these platforms, Brainlab Connected Care uses only industry-standard security features through HTTPS, including encrypted storage and transmission of sensitive data, security logging sub-systems, and support for TLS 1.2 to ensure that all data transmitted is safely encrypted with Advanced Encryption Standard (AES) 256-bit.

LOCAL STOCK NUMBER: 89109-04

CLINICAL CONSULTATION IMAGE GUIDED SURGERY (1 CASE) On-site clinical support by a qualified and trained Brainlab Service staff for one clinical treatment with a Brainlab image guided surgery system. NOTE: This service is provided from 8:00am to 5:00pm on weekdays excluding Brainlab holidays and requires 48 hours advance notice. Travel included.

LOCAL STOCK NUMBER: 82093-01

USER TRAINING CRANIAL (1 DAY) The Brainlab Onsite Application Training Program (OAT) is a three-hour training program for all members of a clinical team who utilize Brainlab IGS products. Onsite training offers participants the opportunity to gain a basic proficiency and comfort level in using IGS technology. Participants use the equipment and software to demonstrate proficiency in OR setup, patient registration, planning, navigation, and basic troubleshooting for a navigated case. Each one-day OAT purchase includes the following: ? 2) three-hour training sessions for staff and surgeons, maximum six participants per session ? Eligible for IACET CEUs with completion of training ? Participant educational materials ? Travel and accommodations for Application Trainer Cranial OAT purchases are transferable toward the following product trainings: ? BOLD ? CMF ? Fibertracking ? IGSonic ? Microscope ? Stereotaxy ? Third-party ultrasound

LOCAL STOCK NUMBER: 81012-01

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date…