Thursday, December 9, 2010

Why would Duke Medical orthopedic surgeon have Utah medical license?

Duke University is supposed to have a medical school and its professors are supposed to be primarily focused on research, medical advancements at Duke University School of Medicine.


Why then does the Head of Adult Orthopedic Reconstruction (Dr Michael Bolognesi) maintain a medical license in Utah?



Development Agreement With Michael P. Bolognesi 
Effective Date:
January 23, 2006
Parties:
Sectors:
Governing Law: 
Exhibit 10.41
EXECUTION COPY
DEVELOPMENT AGREEMENT
BETWEEN AMEDICA CORPORATION AND MICHAEL BOLOGNESI M.D.
This Development Agreement (this " Agreement" ) is made and entered into as of the 21 st day of January, 2006 (the " Effective Date" ), by and between AMEDICA CORP., a Delaware corporation (" Amedica" ), and Michael Bolognesi, M.D. (" Bolognesi).
RECITALS:
A. Amedica is in the business of designing, developing and selling various products and applications for medical and biomedical uses and from various materials, including the use of advanced ceramic materials;
B. Amedica desires to continue to encourage the conceiving, development, testing, providing education and dealing with novel devices for implant in or use with hip and knee reconstructive medical and surgical procedures (" Devices" ), whether manufactured from ceramic materials or other materials;
C. Bolognesi an orthopedic surgeon having knowledge and expertise relating to hip and knee reconstructive procedures; and
D. The parties desire to enter into arrangements between the parties to assist in the future development, approval, trial and clinical use of Devices.
NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree and represent as follows:
1. Definitions .
For purposes of this Agreement, the following terms shall have the following definitions:
a. " Development Services" means the development and related services as requested by Amedica relating to the conceptualization, development, testing, approval and related matters involving the Devices more fully described in Section " b" below;
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
b. " Devices" are exclusively limited to those designated in Schedule " A" attached hereto and includes all ideas, discoveries, creations, improvements, know-how, inventions, designs, developments, apparatus, techniques, methods, processes, and materials, whether or not patentable, including all rights to obtain, perfect or enforce any proprietary interests therein, pertaining to such devices as limited in Schedule A, which Bolognesi, whether alone or in concert with others, may conceive, reduce to practice or develop during the Term (or, if based on or related to any confidential or proprietary information of Amedica, within [***********] after the termination of this Agreement), alone or in conjunction with another, or others, whether during or out of regular business hours, and whether at the request or upon the suggestion of Amedica.
2. Cooperative Development Arrangements .
The parties intend that Bolognesi shall diligently perform the Development Services and provide reasonable input and expertise hereunder. The Development Services shall include, without limitation, the following:
a. Examining and reviewing the characteristics of the Devices and the nature of the materials with which the Devices are constructed;
b. Providing expertise in ideas and testing pertaining to the Devices, and coordination with other Amedica personnel and third-parties related to such testing, as requested by Amedica;
c. Providing guidance and assistance in the clinical details of the Devices;
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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
d. Assisting by providing the written portions of the patent applications pertaining to the Devices as determined by Amedica and approved by Bolognesi; and
e. Assisting by providing the written portions of applications for regulatory approval for the Devices or surgical processes for their implantation or other use.
3. Term and Termination .
a. The term (" Term" ) of this Agreement shall commence as of the Effective Date and shall continue until the later of:
(i) Ten (10) years from the date hereof; or
(ii) The expiration of patent rights on the Devices, unless earlier terminated as provided hereunder.
b. Either party has the right to terminate this Agreement at any time upon thirty (30) days prior written notice to the other. Upon termination, Amedica' s sole obligation to Bolognesi will be to pay any then outstanding unpaid fees, royalties or other compensation due Bolognesi under the terms of this contract and to reimburse Bolognesi for then outstanding reimbursable expenses. Royalty payments rightfully due Bolognesi will continue being paid by Amedica to Bolognesi or his designated beneficiary after the termination of this agreement. Further, Bolognesi will have the option to sell any and all Amedica stock options then owned by Bolognesi back to Amedica at the market value per share. 4. Compensation for Assignment and Sale of Proprietary Rights .
a. As full consideration for the Development Services related solely to [*********************************************] and any assignment of right [*********************************************] to Amedica pursuant to Section 9 hereof, Amedica shall pay Bolognesi the total of the following:
(i) Bolognesi shall, in the form of royalty or similar payments, payable on a monthly basis, receive [**********] of the Net After-Tax Profits for the [*********************************************] from Amedica; provided, that this is subject to the provisions of Subsection 4(d) below.
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b. As full consideration for the Development Services related solely to the [*********************************************] and any assignment of right in Devices related to the [*********************************************] , Amedica pursuant to Section 9 hereof, shall pay Bolognesi the total of the following:
(i) Bolognesi shall, in the form of royalty or similar payments, payable on a monthly basis, receive a total of [**********] of the Net After-Tax Profits; provided, that this is subject to the provisions of Subsection 4(d) below.
c. As full consideration for the Development Services related solely to the [*********************************************] and any assignment of right in Devices related to the [****************************************] , Amedica pursuant to Section 9 hereof, shall pay Bolognesi the total of the following:
(i) Bolognesi shall, in the form of royalty or similar payments, payable on a monthly basis, receive a total of [**********] of the Net After-Tax Profits; provided, that this is subject to the provisions of Subsection 4(d) below.
d. " Net After-Tax Profits" is defined as that portion of profits received by Amedica attributable to the sale of Devices, after deducting from all gross proceeds from such sales the costs and expenses attributable to the development, testing, marketing and sale of the Devices (but not including any Amedica overhead or expenses unrelated to the Devices), and less all sales, use, occupation or excise taxes and all income taxes applicable to income generated from the Devices.
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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
e. Upon Bolognesi' s death, or upon letters from two independent physicians that Bolognesi is disabled and unable to perform the nature of the Development Services hereunder, this Agreement shall terminate as to Bolognesi; provided, that Bolognesi or Bolognesi' s designated beneficiary, shall continue to be entitled to receive the royalties as provided herein, applicable to all Devices completed for marketing prior to the date of death or disability.
f. Notwithstanding any provision herein to the contrary, income used for calculating royalties payable to Bolognesi hereunder shall not include any sales attributable to the use of any Devices by any hospital or surgical center where Bolognesi (or a partner, shareholder, employee or contracting physician) currently practices medicine. No provision under this Agreement, either overtly or covertly, directly or indirectly, requires or contemplates that Bolognesi make any recommendations to Bolognesi' s patients or health care facilities with respect to Amedica' s Devices or other products. There shall be no adjustment to the percentage of royalties, or the rate of any other compensation, resulting from the presence of or absence of, any recommendations of Amedica' s Devices or other products to Bolognesi' s patients or health care facilities by Bolognesi.
g. Amedica shall maintain separate accountings relating to the Devices. Bolognesi shall, at all times, have reasonable access to examine Amedica' s books and records relating to the Devices.
h. Bolognesi acknowledges that the payment provisions of this Section 4 represents the sole agreement between the parties with regard to Bolognesi' s compensation for
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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company' s application requesting confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
all Development Services and any assignment of rights to the Devices; and Amedica shall not be obligated to make, or otherwise be liable for, any additional payment of compensation or reimbursement of expenses with regard to Development Services or the Devices or other similar type payment. It is the parties' intent that this Agreement provide for the " sale or exchange of a capital asset" by Bolognesi to Amedica under Internal Revenue Code Section 1235 entitled " Sale or Exchange of Patents," and that all payments made to Bolognesi hereunder shall be taxed as long-term capital gains. Nothing in this Agreement to the contrary shall imply that the parties intend that the payments to Bolognesi hereunder shall be for anything other than the transfer of all proprietary rights that Bolognesi may have in the Devices. Amedica is making no warranties or representations, however, as to ultimate taxability of the payments to Bolognesi hereunder.
5. Exclusivity .
Amedica acknowledges that Bolognesi has other professional business and investment dealings in addition to his responsibilities under this Agreement and that Bolognesi will not be required to devote his time exclusively to his responsibilities hereunder. Notwithstanding any provision herein to the contrary, Bolognesi agrees that during the Term, Amedica shall have the exclusive rights to the Devices.
6. Confidentiality .
 a ...


 Amedica?  What exactly is Amedica?


Amedica Corporation has established itself as the leader in supplying MC²® silicon nitride spinal implants. Its products may represent a new standard of care based on durability, performance, unique imaging characteristics, and hydrophilicity. Silicon nitride implants are radiolucent with clearly visible boundaries – a major advantage for inter-operative implant placement and post-op assessment. Amedica understands the appreciation of its implants start with the OR experience. But we also know that long term performance is the end goal and we are confident that the benefits of Amedica’s material technology will result in long term satisfaction.
http://goo.gl/AnFsQ

Good to know that Dr Michael Bolognesi can multi-task  and earn some money on the side.  Less good that he is not completely dedicated to the betterment of medical care and education at Duke University School of Medicine and Duke University Hospital.  


Young people go to Duke School of Medicine to learn medicine from dedicated professors.  And patients go to Duke Medical because they hope/believe that the physicians and surgeons are 100% dedicated to medical advancements at Duke University.


To that extent, shame of Dr Michael Bolognesi.  IMHO, he misleads students and patients.


As his patient during a serious operation, I would have preferred that Dr Michael Bolognesi was more focused on completely cleaning out the bone infection from my tibia than focused on earning money on the side.  


I am all about physicians and surgeons attending seminars and association meetings.  But this trend towards side contracts with medical device suppliers brings the issue of "where are the doctor's values" into bright focus.


December 10, 2010, marks 3 months since Dr Michael Bolognesi admitted me to Duke University Hospital.  Today, I am in horrific pain, still have osteomyelitis (bone infection) and have lost all confidence in the medical profession.


I am shocked that Duke University would allow its Medical School professors to have side gigs.  It is my understanding that residents  generally cannot "moonlight."


In the event that Dr Michael Bolognesi (or any other medical school professor) enters into contracts for employment and compensation that relate directly to his work with Duke University, it seems unethical to leave Duke University out of the compensation stream.


At some point, Dr Bolognesi needs to make an ethical decision - to whom does the physician owe his primary duty of loyalty and care?  


1.  Duke University (employer number 1), 
2.  Amedica, DePuy (or any of the other many employer number 2s),
3.  the patient.

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