EX-10.22 12 fzmd-ex1022_76.htm EX-10.22 fzmd-ex1022_76.htm

EXHIBIT 10.22

Addendum

to the

Spinal Fusion Purchase Agreement

between

Texas Health Resources

and

CPM Medical

August 7, 2015

The Agreement to which this Addendum is attached and incorporated and is executed by and between CPM Medical ("Vendor"), and Texas Health Resources with its principal place of business at 612 East Lamar Blvd., Suite 1100, Arlington, Texas 76011 ("Customer"), dated as of the date hereof (the "Agreement"). In the event of a conflict between this Addendum and the Agreement, this Addendum shall control. The parties hereby agree as follows:

1.

The companies agree to extend the existing Spinal Fusion Purchase Agreement between the parties for the period of January 1, 2016 through June 30, 2017.

2.

All other Terms and Conditions of the agreement shall remain in effect.

AGREED:  CPM Medical

 

 

 

By:  

 

Date:  

Name:  

 

 

Title:  

 

 

AGREED: Texas Health Resources

 

 

 

By:  
John B. Gaida
Senior Vice President
Texas Health Resources

 

 

Date:  

 


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Appendix

Texas Health Resources

Entity Listing

HOSPITALS

Texas Health Arlington Memorial
Hospital
800 W. Randol Mill Rd
Arlington, TX 76012

Texas Health Harris Methodist Hospital Southwest Fort Worth 6100 Harris Parkway Fort Worth, TX 76132

Texas Health Presbyterian Hospital Kaufman 850 Highway 243 West Kaufman, TX 75142

Texas Health Harris Methodist
Hospital Cleburne
201 Walls Drive
Cleburne, TX 76031

Texas Health Presbyterian
Hospital Dallas
8200 Walnut Hill Ln.
Dallas, TX 75231

Texas Health Presbyterian
Hospital Plano
6200 W. Parker Blvd
Plano, TX 75093

Texas Health Harris Methodist
Hospital Fort Worth
1301 Pennsylvania Avenue
Fort Worth, TX 76104

Texas Health Harris Methodist
Hospital Stephenville
411 N. Belknap
Stephenville, TX 76401

Texas Health Specialty Hospital
Fort Worth
1301 Pennsylvania Ave.
Fort Worth, TX 76104

Texas Health Harris Methodist
Hospital Azle
108 Denver Trail
Azle, TX 76020

Texas Health Presbyterian
Hospital Allen
1105 Central Expwy North
Allen, TX 75013

Texas Health Harris Methodist
Hospital H.E.B,
1600 Hospital Parkway
Bedford, TX 76021

Texas Health Presbyterian
Hospital Denton
3000 N. Interstate 35
Denton, TX 76201

Texas Health Harris Methodist
Hospital Alliance
10864 Texas Health Trail
Fort Worth, TX 76244

CORPORATE OFFICE
Texas Health Resources
612 E. Lamar Boulevard
Arlington, TX 76011

THR AFFILIATE HOSPITALS - THPR

Physicians Medical Center, LLC
d/b/a Texas Health Center for
Diagnostics & Surgery
6020 West Parker Road
Plano, Texas 75093

Rockwall Regional Hospital, LLC
d/b/a Texas Health Presbyterian
Hospital Rockwall
3150 Horizon Road
Rockwall, Texas 75032

Southlake Specialty Hospital, LLC
d/b/a Texas Health Harris
Methodist Hospital Southlake
1545 E. Southlake Boulevard
Southlake, Texas 76092

Flower Mound Hospital Partners,
LLC d/b/a Texas Health
Presbyterian Hospital Flower Mound
4400 Long Prairie Road
Flower Mound, Texas 75028

 

 


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Appendix A- Constructs and Pricing Terms

Texas Health Resources

Spinal Fusion — Effective February 15, 2012 to June 30, 2017

Spine Construct

Definition

Open Vendor Construct Price

Screw, Cervical

Any screw used to secure cervical plates to cervical vertebrae; Including but not limited to self-drilling, self-tapping, cancellous, cortical, locking, cannulated, translational, domed, transitional, semi-constrained, fixed or variable angle, washers, nuts, set screws, etc.

$150

Plate, Cervical 1-3 Levels

One, two, or three level translating and fixed plate; including hole covers, integrated locking mechanisms and all materials

$800

Plate, Cervical 4+ Levels

Four + level translating and fixed plate; including hole covers, integrated locking mechanisms and all materials

$900

Plate, Occipital

Translational single and multi-level plate (2 and 3 levels) involving Cl; includes hole covers includes integrated locking mechanisms and all materials

$1800

Screw, Lumbar

Any screw/bolt used to secure anterior, posterior or lateral plates to Thoracic-Lumbar-Sacral vertebrae; including but not limited to self-drilling, self-tapping, cancellous, cortical, locking, cannulated, translational, domed, transitional, semi-constrained, fixed or variable angle, washers, nuts, set screws, etc.

$175

Plate, Lumbar

Any anterior Thoracic-Lumbar-Sacral plate - includes anterior single or multi - level plate and cover if applicable; excludes Buttress plates

$2800

Plate, Posterior or Lateral

Any posterior or lateral plates for Thoracic-Lumbar-Sacral fixation(i.e. Arch, Core)

$500

Buttress Assembly

Includes any buttress plate & screws or staple assembly

$600

Hooks and Offset Assembly

Includes any fixed-angle, posted or monoaxial hook or offset assemblies including all washers, nuts, collars, off-sets, locking caps, blockers, set screws, etc. required for the assembly and / or attachment of the hooks offsets to the rods (or links/hooks).  Includes all Anterior / Posterior / Cervical / Lumbar / Thoracic / hooks used with rods.

$400

Pedicle Screw Assembly, fixed angle

Includes any fixed-angle, posted or monoaxial pedicle screw assemblies; screw assembly includes all washers, nuts, collars, off-sets, locking caps, blockers, set screws, etc. required for the assembly and / or attachment of the screws to the rods (or links/hooks).  Includes all Anterior / Posterior / Cervical / Lumbar / Thoracic / Iliac fixed angle, posted or monoaxial screws used with rods.

$650

Pedicle Screw Assembly, Polyaxial

Any Pedicle Screw used in conjunction with a rod (or link).  Anterior / Posterior Cervical / Lumbar / Thoracic / Iliac (including multi-axial or variable angle extended tab, reduction, favored angle, fenestrated, or those used with flexible rod and cord) and dynamic screws include all washers, nuts, collars, off-sets, locking caps, blockers, set screws, etc. required for the assembly and / or attachment of the screws to the rods.  Includes all multi-axial and variable/favored angle screws used with rods (or link).

$750

Pedicle Screw Assembly, Cannulated

Any Cannulated Pedicle Screw used in conjunction with a rod (or link).  Anterior I Posterior Cervical / Lumbar / Thoracic I Iliac (including multi-axial or variable angle or those used with flexible rod and cord) and dynamic screws include all washers, nuts, collars, off-sets, locking caps, blockers, set screws, etc. required for the assembly and / or attachment of the screws to the rods.  Includes all multi-axial and variable angle screws used with rods (or link).

$850

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Spine Construct

Definition

Open Vendor Construct Price

Pedicle Screw Assembly, dual threads on core

Any Pedicle Screw used in conjunction with a rod (or link) that has a dual thread design on the screw core. Anterior / Posterior Cervical / Lumbar / Thoracic / Iliac (including multi-axial or variable angle extended tab, reduction, favored angle, fenestrated, or those used with flexible rod and cord) and dynamic screws include all washers, nuts, collars, off-sets, locking caps, blockers, set screws, etc. required for the assembly and / or attachment of the screws to the rods. Includes all multi -axial and variable/favored angle screws used with rods (or link).

$1050

Rod <300mm

Cervical or Lumbar/Thoracic (straight, tapered, threaded, or curved, any material or diameter) Includes dynamic, corded, links or flexible rods

$200

Rod >300mm

Cervical or Lumbar/Thoracic (straight, tapered, threaded, or curved, any material or diameter)

$300

Rod, balled or hex end(s) of any length

Cervical or Lumbar/Thoracic/Sacral (straight, tapered, threaded, or curved, any material or diameter) Includes rods or any length with one or two balled/hex ends as well as PEEK rods

$300

Rod, Semi Rigid

Any combination of semi-rigid rod components such as cords, spacers, bumpers, spools, end spools, and screw end assemblies.  Pricing is per case assembled and includes both sides (not inclusive of pedicle screws).

Note: Requires prior approval.  Semi-Rigid systems are only indicated for use as an adjunct to a fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudoarthrosis).  Off-label use can result in denied payment.  If this device is used as the only primary rod for spinal fusion cases, payment will be made at the standard rod price.

$2,000/case Note: Requires prior approval.

Crosslink / Domino Connectors

Crossbar (rod-to-rod), Fixed, Multi-axial, Multi-angle, Low profile, and includes multi-axial expandable crosslinks as well as inter rod connector designed for the purpose of rod extension

$700

Cervical Spacer or Cage

Any cervical spacer with non bone material such as PEEK / Titanium / Porous or coated metal. or Carbon Fiber

$800

IFD Thoracic/Lumbar/ Sacral PLIF

Any Thoracic/Lumbar/Sacral inter-body fusion device placed through a posterior approach (PLIF) with two devices of non bone material such as PEEK I Titanium / Porous or coated metal or Carbon Fiber or any impacted or screw in fusion device in any non bone material

$1500

IFD Thoracic/Lumbar/ Sacral TLIF

Any Thoracic/Lumbar/Sacral inter-body fusion device placed through a posterior Transforaminal approach (TLIF) with one device of non bone material such as PEEK / Titanium / Porous or coated metal or Carbon Fiber or any impacted or screw in fusion device in any non bone material

$2800

IFD Thoracic/Lumbar/ Sacral ALIF

Any Thoracic/Lumbar/Sacral inter-body fusion device placed through an anterior approach of non bone material such as PEEK / Titanium / Mesh / Porous or coated metal or Carbon Fiber.

$3000

IFD Direct Lateral

Any inter-body fusion device placed through a lateral anterior approach of non bone material such as PEEK / Titanium / Porous or coated metal or Carbon Fiber (ie, XLIF, Clydesdale, Transcontinental )

$3800

IFD Direct Lateral — Specialty Versions

Any inter-body fusion device placed through a lateral anterior approach of non bone material such as PEEK / Titanium / Porous or coated metal or Carbon Fiber of non standard sizes and configurations

$4400

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Spine Construct

Definition

Open Vendor Construct Price

Vertebral Body Replacement (VBR)

Any coipectomy spacer that includes expandable cages; modular ALIF/TLIF; reinforcing screws; or devices assembled within the vertebral space

$3800

Modular VBR

See VBR

$3800

Expandable Cages <= 1 level

See VBR (excludes intervertebral body/disc device)

$3800

Expandable Cages > 1 level

Expandable VBR of any diameter that cover more than 1 vertebral body (greater than 60 mm expanded)

$5,800

Interspinous Spacer

i.e. X-stop

$4000/case

Spinous Process Plate

Non segmental lumbar fixation assembly, includes device body and fixation as well as screws and/or plates. (ie, Aspen, Affix, Spire, SP-Fix) If a subsequent device is used in the same procedure, the subsequent device will be discount 50% from the construct price

$4,000

Cervical Disc

Includes all implant components and disposables required to implant a cervical artificial disc device; (i.e., Prodisc C, Prestige)

*Requires prior approval and authorization.

$4,500

Lumbar Disc

Includes all implant components and disposables required to implant a lumbar artificial disc device; (i.e., Charte, Prodisc L)

*Requires prior approval and authorization.

$7,500

Facet Screws

Any facet screw and delivery devices such as teleport or gun

$800

Temporary Fixation Pins / Tacks/taps

 

$65

Wire

 

$65

Drill bit

 

$100

Cable

 

$240

Targeting needle

Any disposable targeting needle (ie Jamshidi)

$50

Stand Alone Integrated Devices — Lumbar

Stand-alone device (assembled price including screws or fixation pins) that accomplish similar interventions may have a cumulative price effect (i.e. SynFix-LR, Pillar-SA, Independence, Magnum-P+, ROI-A) Limited to only two assembled devices per procedure/discharge.  Any subsequent device used in the same case will be discount 50% from the construct price.

$5600

Stand Alone Integrated Devices - Cervical

Stand-alone devices (assembled price including screws or fixation pins) that accomplish similar interventions may have a cumulative price effect (i.e. Zero-P, Mosaic, Coalition, ROI-C) Limited to only one device per procedure/discharge.  Any subsequent device used in the same case will be discount 50% from the construct price.

$2600

Insertion Supplies, Lateral ALIF — kit

Includes any and all disposable components and supplies required to implant a lateral anterior lumbar interbody fusion device (i.e., XLIF, Transcontinental, Clydesdale, GLIF, etc) and includes items such as but not limited to illumination, cords, shims, blades, k-wire, dilatators, in either kits or provided individually. etc.

$500/case

Insertion Supplies, Lateral ALIF - components

Shims$50/case

Light source/cable$400/case

Annulotomy knife$50/case

 

Intraoperative Monitoring

Neurological intraoperative monitoring assembly - includes all disposable components (tips, probes, dilators, electrodes, cables, etc) required.  Limited to Lateral ALIF procedures.

$500/case

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Spine Construct

Definition

Open Vendor Construct Price

Other Devices — exceptions

Devices not addressed in any constructs listed above must be included in the product formulary exhibit prior to use in the hospital with a mutually agreed upon price. (i.e., AxiLIF)

TBD

 

Any implant or assembly delivered by Vendor must fall into one of the defined categories without exceptions, up charges, or additions. Any deviation from established pricing must he approved in advance or items are not charged to customer. No up charges for substitution ol' product components will be made without prior approval by Karen Kiefer or designee. If any implant is provided that is not on the approved product formulary in Appendix A, payment will be made at the construct price.

Should Vendor provide any technologies not contained in Attachment I3 currently on file with TIIR, Vendor will be paid at the defined construct price as defined by TI [R.

This Spinal Fusion Implant Formulary may be updated periodically with the approval of the Hospital's Implant Formulary Committee.

Broken instrumentation will be replaced at no charge by the Vendor unless there is evidence of abuse by hospital personnel.

Lost and/or misused instrumentation that was caused by Hospital personnel will he the responsibility of the Hospital at 70% off 2012 list price.

No fees for instrumentation (Reusable).

Explanted /wasted implants are paid at 50% off the construct price.

All devices subject to verification. If any questions arise regarding classification of a device, the supplier will provide a surgical technique guide, FDA documents, and a product brochure.

 

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EXHIBIT 10.22

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