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:  




 




1

 



 

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 
	
 
	
 







- 2 -

 



 

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




- 3 -

 



 


			
	
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




- 4 -

 



 


			
	
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




- 5 -

 



 


			
	
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.




 

- 6 -

 



EXHIBIT 10.22



7