As filed with the Securities and Exchange Commission on February 15, 2013

Registration No. 333-185389

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



 

AMENDMENT NO. 2 TO
FORM S-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933



 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

(Exact Name of Registrant as Specified in Its Charter)



 

   
Delaware   3841   45-5210462
(State or other Jurisdiction of
Incorporation or Organization)
  (Primary Standard Industrial
Classification Code Number)
  (I.R.S. Employer
Identification Number)

84 October Hill Road, Holliston, MA 01746
(508) 893-8999

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)



 

David Green
President and Chief Executive Officer
Harvard Apparatus Regenerative Technology, Inc.
84 October Hill Road, Holliston, MA 01746
(508) 893-8999

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)



 

Copies to:

 
Josef B. Volman, Esq.
Chad J. Porter, Esq.
Burns & Levinson LLP
125 Summer Street
Boston, MA 02110
(617) 345-3000
  Ilan S. Nissan, Esq.
Christopher J. Austin, Esq.
Goodwin Procter LLP
620 Eighth Avenue
New York, NY 10018
(212) 813-8800


 

Approximate date of commencement of proposed sale to the public:

Promptly after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box: o

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act:

 
Large accelerated filer o   Accelerated filer o
Non-Accelerated filer o
(Do not check if a smaller reporting company)
  Smaller reporting company x

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

 

 


 
 

TABLE OF CONTENTS

The information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

Subject to Completion, Dated February 15, 2013

[GRAPHIC MISSING]

         Shares of Common Stock



 

This is an initial public offering of common stock of Harvard Apparatus Regenerative Technology, Inc. We are selling          shares of our common stock. Harvard Apparatus Regenerative Technology, Inc. is currently a wholly-owned subsidiary of Harvard Bioscience, Inc.

Prior to this offering, there has been no public market for our common stock. It is currently estimated that the initial public offering price per share will be between $      and $     . We intend to apply to list our common stock on the NASDAQ Capital Market under the symbol “HART”.

We are an “emerging growth company” under federal securities laws and are subject to reduced public company disclosure standards. See “Prospectus Summary — Implications of Being an Emerging Growth Company.”

Investing in our securities involves significant risks. See “ Risk Factors ” beginning on page 8 .

   
  Per Share   Total
Initial Public Offering Price   $     $  
Underwriting Discounts and Commissions   $     $  
Offering Proceeds Before Expenses   $     $  

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

The underwriters may also exercise their option to purchase up to an additional       shares of common stock from us, at the public offering price, less the underwriting discounts and commissions for a period of 30 days after the date of this prospectus.

The shares will be ready for delivery on or about            , 2013.

Summer Street Research Partners

The date of this prospectus is            , 2013.


 
 

TABLE OF CONTENTS

  

[GRAPHIC MISSING]

[GRAPHIC MISSING]


 
 

TABLE OF CONTENTS

TABLE OF CONTENTS

 
  Page
PROSPECTUS SUMMARY     1  
RISK FACTORS     8  
MARKET DATA     28  
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS     28  
OUR SEPARATION FROM HARVARD BIOSCIENCE     29  
USE OF PROCEEDS     32  
DETERMINATION OF OFFERING PRICE     32  
DIVIDEND POLICY     32  
CAPITALIZATION     33  
DILUTION     35  
SELECTED HISTORICAL FINANCIAL DATA     37  
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS     38  
BUSINESS     45  
MANAGEMENT     70  
DIRECTOR AND EXECUTIVE COMPENSATION     74  
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS     82  
PRINCIPAL STOCKHOLDERS     93  
DESCRIPTION OF SECURITIES     95  
SHARES AVAILABLE FOR FUTURE SALE     101  
MATERIAL U.S. FEDERAL TAX CONSIDERATIONS TO NON-U.S. HOLDERS     103  
UNDERWRITING     107  
LEGAL MATTERS     112  
EXPERTS     112  
WHERE YOU CAN FIND MORE INFORMATION     112  
INDEX TO FINANCIAL STATEMENTS     F-1  

We have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give to you. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of our common stock.

Dealer Prospectus Delivery Obligation

Until            , 2013 (25 days after the date of this prospectus), all dealers that buy, sell or trade our common stock, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to the obligation of dealers to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

i


 
 

TABLE OF CONTENTS

PROSPECTUS SUMMARY

The following summary highlights selected information contained in this prospectus. This summary does not contain all the information that may be important to you. You should read the more detailed information contained in this prospectus, including but not limited to, the risk factors beginning on page 8 . References to “we,” “us,” “our,” or the “company” refer to Harvard Apparatus Regenerative Technology, Inc.

Business Overview

We are a clinical stage regenerative medicine company developing life-saving medical devices.

Our first products are a bioreactor and a synthetic scaffold that can be used by surgeons to create a replacement trachea, or airway, for patients who need an airway transplant. We believe our products are the first to enable the application of regenerative medicine techniques to the production and transplant of complex, three-dimensional human organs like the trachea. Our bioreactor technology has been used in six successful human airway transplant surgeries, including what we believe to be the world’s first transplant of a regenerated airway. In addition, we believe the second surgery using our technology was the world’s first transplant of a regenerated airway using a synthetic scaffold. The patients who received these two airway transplants are alive more than four years and 20 months, respectively, following their surgeries, and each of these surgeries was published in The Lancet , one of the world’s most respected peer-reviewed medical journals. The six human airway transplants to date have been led by Professor Paolo Macchiarini, a world-renowned thoracic surgeon of the Karolinska Instituet, one of Europe’s leading research hospitals.

Our products are currently in development and have not yet received regulatory approval for sale anywhere in the world.

We believe our technology could enable surgeons to cure nearly all primary trachea cancers. Our products address the critical challenges to trachea transplant: the shortage of suitable donor tracheas and the risk and expense of lifelong anti-rejection drug therapy. Because the scaffolds are synthetic, our technology will eliminate the need to wait for suitable donor tracheas. Our technology also obviates the need for anti-rejection drug therapy because the surgeon uses the patient’s own bone marrow cells to seed the scaffold. In addition, patients with trachea cancer treated using our products have not required either chemotherapy or radiation therapy after the transplant, thus potentially eliminating the significant side effects and expense of such therapies. Because these substantial costs and risks can be reduced or even eliminated with our technology, we believe our products can both help save lives and reduce overall healthcare costs. None of the surgeries using our products have involved human embryonic stem cells and we do not currently expect surgeons to use such cells with our products.

We intend to seek separate, independent 510(k) clearances in the U.S. and CE marking in the EU to allow us to market our trachea scaffolds, bioreactors and clinical infusion pumps for medical-device uses. In addition, we may seek approval under the orphan biologics pathway for the use of our scaffold and bioreactor system, including cells, for regenerated trachea transplant, which could provide market exclusivity for up to seven years. Based on initial review of FDA and EU regulatory precedent, and our understanding of the status of ongoing clinical investigation of the trachea scaffold products, we expect to receive regulatory approval to market our regenerated trachea transplant products in the EU by the end of 2015 (under the advanced therapy medicinal products regulations) and, assuming our trachea transplant products qualify for accelerated review, we expect to receive FDA approval to market our trachea transplant products in the U.S. by the end of 2016. We note, for example, that both the orphan drug pathway and ‘Fast track’ review with accelerated review times are available for products intended for the treatment of a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for such a condition. We believe that both of these criteria apply to our trachea transplant products. The estimated regulatory approval timelines are based on our key assumption that we will be able to market the tracheal scaffold, bioreactor, and clinical infusion pump components of the regenerated tracheal transplant products as medical devices in both the U.S. and the EU. The estimated timelines are also grounded on the assumption that the regenerated tracheal transplant products will be reviewed in the EU under the advanced therapy medicinal products regulations and in the U.S. under FDA’s ‘Fast track’ review and accelerated review times. Each of these assumptions are discussed further and called out as relevant risk factors.

1


 
 

TABLE OF CONTENTS

Two regenerated trachea transplants performed in Russia in June 2012 began a clinical trial of trachea transplants for patients with either trachea cancer or trachea damage. This trial is funded by a $5 million grant from the Russian government to the Krasnodar Regional Hospital, one of Russia’s leading transplant centers. In addition, the EU has approved a separate $5 million grant with Dr. Macchiarini as principal investigator to fund two clinical trials in trachea transplant using our products. We expect these two EU trials to begin in 2014. We intend to use the results of these trials, together with the data collected on compassionate-use patients both in the U.S. and overseas, to help support our submission for approval to market our trachea transplant products.

In addition to the trachea, we believe that our products are applicable to the regeneration of other organs. Our collaborators are working on regenerating the lungs, gastrointestinal tract, heart valves and heart using our products. For instance, a collaborator of ours, Dr. Harald Ott of Massachusetts General Hospital, has succeeded in using one of our solid organ bioreactors to regenerate and transplant a whole lung in a rat. Another collaborator of ours, Dr. Robert Simari of the Mayo Clinic, is using one of our bioreactors in his research on the potential regeneration and transplant of human heart valves.

Market Opportunity

Current treatments for trachea cancer, such as radiation therapy, chemotherapy and surgery have poor outcomes, resulting in median survival of only 10 months and a five-year survival rate of only 15%. According to an article published in The Lancet Oncology , the incidence of trachea cancer is 2.6 per one million of population, reflecting an addressable market of approximately 2,400 trachea cancer patients per year worldwide. In addition to trachea cancer, certain types of trachea damage can be treated by transplanting a trachea. In particular, patients may receive a tracheotomy, or surgically created hole in their throat, to allow them to breathe. When the tracheotomies are in place for more than a few days, patients are at an increased risk of dying from pneumonia caused by aspiration of foreign material into the lungs. We estimate that there are approximately 3,900 patients per year worldwide with long-term tracheotomies at risk of death from aspiration pneumonia. In addition, there are approximately 250 patients in the developed world who are born without a trachea, a condition called tracheal agenesis, who may be treatable with a trachea transplant.

Combining patients with trachea cancer, trachea trauma and tracheal agenesis, we estimate the total addressable patient population for trachea transplants using our products is approximately 6,500 per year. While these estimates capture the number of new patients annually that are candidates for transplants using our products, they exclude what we believe to be a large pool of existing potential patients.

Additionally, we believe that our technology can also be used to address the lungs, gastrointestinal tract, heart valves and heart transplant markets. We believe that these markets collectively contain millions of potential patients with life-threatening and expensive conditions, and suffer from a lack of suitable donor organs, in addition to considerable logistical and other expenses in procuring organs.

Strategy

Our objective is to be the leading regenerative medicine device company focused on helping save human lives. Our business strategy to accomplish this objective includes:

Target life-threatening medical conditions.   Because we address life-threatening conditions, we believe it is easier to get patient informed consent for treatment, hospital ethics committee or Institutional Review Board approval and government regulatory authority approval as the patients often have poor or no treatment alternatives.
Focus on medical devices rather than cells.   Medical devices generally have easier and lower-cost clinical trial requirements than cellular-based therapies, provided that the FDA agrees that the injection system and bioreactor products we are developing are separate medical devices, and not part of an overall biological seeded scaffold.
Develop products that have a relatively short time to market.   The number of patients with trachea cancer is relatively small and median survival is only 10 months. Thus, we expect the size, length and expense of our trachea transplant trial will be low compared to clinical trials in larger indications with longer survival periods.

2


 
 

TABLE OF CONTENTS

Use trachea transplant as a platform to address other organs.   We believe our experience in developing proprietary scaffolds and bioreactors for trachea transplant gives us substantial expertise and intellectual property for developing products addressing diseases impacting other organs like the lungs, gastrointestinal tract, heart valves and heart.
Supply the complete bioreactor and scaffold system.   Our technology includes the bioreactor and scaffold which are used by the surgeon to create the synthetic organ. We believe there is considerable value in supplying the complete bioreactor and scaffold system.
Collaborate with leading surgeons and institutions.   We have and will continue to collaborate with leading surgeons and institutions such as Professor Macchiarini of the Karolinska Instituet, Dr. Harald Ott of Massachusetts General Hospital, and Dr. Robert Simari of the Mayo Clinic. We believe the use of our products by leading surgeons and institutions will increase the likelihood of broad adoption of our products.

Products

Hollow Organ Bioreactors

Our InBreath hollow organ bioreactor is a device that can be used by a surgeon to seed cells onto a scaffold. The InBreath bioreactor enables the surgeon to:

secure the scaffold to the bioreactor;
seed the patient’s cells on the scaffold under sterile conditions;
automatically rotate the scaffold to allow good cell distribution into the pores of the scaffold; and
remotely monitor the scaffold during the course of the two to three days incubation period before the transplant.

Our InBreath bioreactor has several novel features such as allowing for separate cell seeding conditions on the inside and outside of the scaffold and for pumping cell culture media through the inside of the scaffold without the need for an external pump and tubes. We believe our InBreath hollow organ bioreactor is the world’s first bioreactor that has been used to perform a human transplant of a regenerated organ.

Solid Organ Bioreactors

A solid organ bioreactor shares many of the features of a hollow organ bioreactor such as the ability to seed cells on an organ scaffold and keep them sterile and healthy during the growth phase prior to transplant. However, for solid organs like the heart and lungs, the bioreactor must also supply pulsatile blood flow and ventilation to mimic the natural action of the heart and lungs. In addition, the physiology of the heart and lungs is considerably more complex than that of the trachea and so the measuring, monitoring and control equipment needed is considerably more advanced. During the first half of 2010, one of our physician collaborators, Dr. Harald Ott at Massachusetts General Hospital, succeeded in regenerating a lung that was subsequently transplanted into the body of a rat. In collaboration with Dr. Ott and Massachusetts General Hospital, we designed and developed a novel bioreactor that was used to grow the rat lung used in this procedure.

Scaffolds

A scaffold is a natural or synthetic framework, shaped like the real organ, that is porous to allow cells to penetrate the scaffold, attach and start to grow. The scaffold used for the first regenerated trachea transplant in 2008 was a donated human trachea with its cells removed before being seeded with bone marrow cells taken from the patient. All subsequent trachea transplants using our products have utilized synthetic scaffolds. Because the synthetic scaffolds are manufactured, they can be made to the exact dimensions of the patient and in large quantities. While the synthetic scaffolds used in surgeries to date have been made by third parties, in order to improve the scaffolds, we are collaborating with Professor Macchiarini and others to develop our own scaffold product and manufacturing. We have recently established scaffold manufacturing in our Holliston, Massachusetts facility. Our scaffolds can be made from a variety of plastic polymers such as polyethelyne terephthalate, or PET, which is the same polymer used in the well-known brand of implantable materials

3


 
 

TABLE OF CONTENTS

known by the trade name Dacron. PET has a long history of safe use in long-term human implants. We have manufactured over 100 prototype scaffolds and we intend to provide our proprietary scaffolds to surgeons for use in future transplants. We believe that our scaffolds will be superior in quality compared to those used in prior surgeries.

Clinical Infusion Pump

We are also developing a clinical infusion pump that can be used by clinicians as a cell injection system. This product will allow clinicians to inject cells directly into damaged tissue. In addition to the cell injection applications, we expect our clinical pump will be used for infusing drugs in general hospital applications. This clinical pump is based on the technology underlying Harvard Bioscience Inc.’s market leading Harvard Apparatus research syringe pumps.

Relationship with Harvard Bioscience

We are a wholly-owned subsidiary of Harvard Bioscience. We were incorporated by Harvard Bioscience to provide a means for separating its regenerative medicine device business from its other businesses. Harvard Bioscience has been designing and manufacturing devices for life science researchers for over 100 years. Harvard Bioscience first explored the regenerative medicine market in 2007 and began focusing on providing devices to scientists involved in regenerative medicine research in 2008. Since early 2009, Harvard Bioscience’s regenerative medicine device business initiative operated as a division of Harvard Bioscience. Harvard Bioscience decided to separate its regenerative medicine business into our company, a separate corporate entity, to authorize us to raise capital by selling equity and then to spin off its interest in our business to its stockholders. Prior to this offering, Harvard Bioscience will have contributed the assets of its regenerative medicine device business, and approximately $10 million in cash, to our company. We had no material assets or activities as a separate corporate entity until the contribution to us by Harvard Bioscience of those assets and that business. We will continue to pursue our business of developing and making devices for regenerative medicine researchers and clinicians.

Immediately following this offering, Harvard Bioscience will own at least 80% of our outstanding common stock. Harvard Bioscience will continue to control our operations through such ownership but will no longer fund our operations following the closing of this offering. Following the closing of this offering, we will use the net proceeds of this offering and the $10 million cash contribution from Harvard Bioscience to fund our operations. Harvard Bioscience plans to distribute all shares of our common stock it then owns to Harvard Bioscience’s stockholders, on or after the date that is four months after the completion of this offering by means of a spin-off, which is a pro rata distribution by Harvard Bioscience of the shares of our common stock it owns to holders of Harvard Bioscience’s common stock. At such point Harvard Bioscience will no longer be a stockholder of our common stock and will no longer control our operations. Harvard Bioscience has the right to terminate its plans to complete the distribution if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the distribution is not in the best interests of Harvard Bioscience or its stockholders. Consequently, we cannot assure you as to when or whether the distribution will occur.

Any such distribution by Harvard Bioscience is also subject to several conditions that must be satisfied (or waived by Harvard Bioscience in its sole discretion), including, among others:

receipt of a private letter ruling from the IRS to the effect that, among other things, the spin-off will qualify as a transaction that is tax-free for U.S. federal income tax purposes under Section 355 and 368(a)(1)(D) of the Internal Revenue Code continuing in effect, and Harvard Bioscience’s receipt of an opinion from Burns & Levinson LLP, counsel to Harvard Bioscience, to the effect that the spin-off will qualify as a transaction that is described in Section 355 and 368(a)(1)(D) of the Internal Revenue Code;
that all actions and filings necessary or appropriate under applicable securities laws in connection with the distribution will have been taken or made, and, where applicable, become effective or been accepted by the applicable governmental authority;
the approval for listing on the NASDAQ Capital Market of the shares of our common stock to be distributed to the Harvard Bioscience stockholders in the distribution;

4


 
 

TABLE OF CONTENTS

that no order, injunction or decree issued by any court or agency of competent jurisdiction or other legal restraint or prohibition preventing consummation of the spin-off or any of the related transactions are in effect; and
that no other events or developments have occurred subsequent to the completion of this offering that, in the judgment of the Harvard Bioscience board of directors, would result in the distribution not being in the best interest of Harvard Bioscience or its stockholders.

Risks Relating to Our Business

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described in “Risk Factors” beginning on page 8 of this prospectus before making a decision to invest in our common stock. If any of these risks actually occurs, our business financial condition and results of operations would likely be negatively affected. In such case, the trading price of our common stock would likely decline, and you may lose part, or all, of your investment. Below is a summary of some of the principal risks we believe we face:

We may be unsuccessful in obtaining on a timely basis or at all, the regulatory clearances and approvals needed to commercially market and distribute our products due to adverse outcomes of clinical trials and other reasons.
We may be unsuccessful in launching products or expanding product offerings in the field of regenerative medicine.
As long as Harvard Bioscience controls us, your ability to influence matters requiring stockholder approval will be extremely limited.
Our medical collaborators may fail in their efforts at researching and developing safe and effective regenerative medical protocols and therapies.
Our success will depend partly on our ability to operate without infringing on, or misappropriating, the intellectual property or confidentiality rights of others.
The regenerative medicine market may not expand, or may not expand in the areas targeted by our products.
Future regulatory changes may affect our business.
If we are unable to effectively protect our intellectual property, third parties may use our technology, which would impair our ability to compete in our markets.
Substantial sales of our common stock may occur following this offering, as well as following the planned distribution of our common stock by Harvard Bioscience, which could cause our stock price to decline.
We are currently experiencing operating losses because we have no revenues to offset our operating costs.
We may need to raise additional capital to fund our activities until we generate positive cash flows and may not be able to obtain such capital on favorable terms or at all.

Implications of Being an Emerging Growth Company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:

only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;
reduced disclosure about our executive compensation arrangements;
no non-binding advisory votes required on executive compensation or golden parachute arrangements; and

5


 
 

TABLE OF CONTENTS

exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.

We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or SEC. We may choose to take advantage of some but not all of these exemptions. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

Corporate Information

We were incorporated under the laws of the State of Delaware on May 3, 2012. Our principal executive offices are located at 84 October Hill Road, Holliston, Massachusetts. Our telephone number is (508) 893-8999. We maintain a web site at www.harvardapparatusregen.com . The reference to our web site is intended to be an inactive textual reference only. The information contained on, or that can be accessed through, our web site is not a part of this prospectus.

The name “Harvard Apparatus” is used under a license agreement between Harvard Bioscience and Harvard University. Harvard Bioscience has granted us a sublicense under this license agreement with respect to the name “Harvard Apparatus” for use in the name Harvard Apparatus Regenerative Technology. With respect to certain trademarks used in this prospectus, “DACRON” is owned by Invista North America S.A.R.L., “Apligraf” is owned by Novartis AG, and “Dermagraft” is owned by Advanced Biohealing, Inc. Other names used herein are for informational purposes only and may be trademarks of their respective owners.

6


 
 

TABLE OF CONTENTS

The Offering

Securities offered    
          shares of common stock
Common stock to be outstanding after the offering assuming the sale of all shares covered by this prospectus    
          shares
Common stock to be held by Harvard Bioscience immediately after this offering    
          shares
Over-allotment option    
    The underwriters have an option for a period of 30 days after the date of this prospectus to purchase up to       additional shares of our common stock solely to cover over-allotments.
Use of proceeds    
    We estimate that we will receive up to $      in net proceeds from the sale of the shares in this offering, based on a price of $      per share (which is the midpoint of the price range set forth on the cover page of this prospectus), and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We will use the proceeds from the sale of the shares for research and development, working capital needs, capital expenditures and other general corporate purposes. See “Use of Proceeds” for more information.
Risk factors    
    The shares of common stock offered hereby involve a high degree of risk. See “Risk Factors” beginning on page 8 .
Dividend policy    
    We currently intend to retain any future earnings to fund the development and growth of our business. Therefore, we do not currently anticipate paying cash dividends on our common stock.
Proposed NASDAQ trading symbol    
    “HART”

Immediately prior to the closing of the sale of the shares in this offering we will amend and restate our certificate of incorporation and effectuate a       for 1 stock split to ensure that our authorized and outstanding capital stock are sufficient to consummate this offering. Unless the context indicates otherwise, the number of shares of common stock to be outstanding after this offering:

assumes the completion of a          for 1 stock split;
excludes       shares of our common stock reserved for issuance under the 2013 Equity Incentive Plan, or 2013 Plan, upon the exercise of stock options, restricted stock units, or restricted stock that will be issued under our employee benefit plans, which will include:
     shares of our common stock reserved for issuance in connection with the initial grants to our executives and employees that will be granted following the determination of the initial public offering price per share of our common stock in this offering, as described in “Director and Executive Compensation — IPO Grants;”
shares of our common stock that may be issued in connection with compensation of our directors, as described in “Director and Executive Compensation — Board of Directors’ Compensation;” and
shares of our common stock that may be issued in connection with the exercise or vesting of options or restricted stock units we issue pertaining to the adjustment and conversion of outstanding Harvard Bioscience equity awards upon the effectiveness of the spin-off, as described in “Director and Executive Compensation — Treatment of Outstanding Harvard Bioscience Equity Awards;”
assumes the underwriters will not exercise their over-allotment option; and
assumes that the shares of our common stock to be sold in this offering are sold at $      per share, the midpoint of the price range set forth on the cover page of this prospectus.

7


 
 

TABLE OF CONTENTS

RISK FACTORS

If you purchase our securities, you will assume a high degree of risk. In deciding whether to invest, you should carefully consider the following risk factors, as well as the other information contained elsewhere in this prospectus. Any of the following risks could have a material adverse effect on our business, financial condition, results of operations or prospects and cause the value of our securities to decline, which could cause you to lose all or part of your investment. We may experience additional risks and uncertainties not currently known to us, or, as a result of developments occurring in the future, conditions that we currently deem to be immaterial may also materially and adversely affect our business, financial condition, cash flows and results of operations.

Risks Relating To Our Business

Risks Associated with Regulatory Clearances and Approvals

If we fail to obtain, or experience significant delays in obtaining, regulatory clearances or approvals in the U.S. and the EU for our products, or are unable to maintain such clearances or approvals for our products, our ability to commercially distribute and market these products would suffer.

We currently do not have regulatory approval to market any of our products. Our products are subject to rigorous regulation by the FDA, and numerous other federal and state governmental authorities in the U.S., as well as foreign governmental authorities. The process of obtaining regulatory clearances in the EU allowing us to affix the CE mark to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances, or CE Certificates of Conformity, necessary to affix the CE mark on our medical devices on a timely basis, if at all. In the U.S., the FDA permits commercial distribution of a new medical device only after the device has received clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or is the subject of an approved premarket approval application, or PMA, unless the device is specifically exempt from those requirements. The FDA will clear marketing of a lower risk medical device through the 510(k) process if the manufacturer demonstrates that the new product is substantially equivalent to other 510(k)-cleared products. High risk devices deemed to pose the greatest risk, such as life-sustaining, life-supporting, or implantable devices, or devices not deemed substantially equivalent to a previously cleared device, require the approval of a PMA. The PMA process is more costly, lengthy and uncertain than the 510(k) clearance process. A PMA must be supported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the device for its intended use.

We intend to seek approvals and clearances in the EU first, and our failure to receive or obtain such clearances or approvals on a timely basis or at all would have an adverse effect on our results of operations.

As further discussed below, there also is a risk that the FDA could seek to regulate the bioreactor and infusion products solely as more-highly regulated components of combination products, subject to potential regulation through the Biologics License Application, or BLA, process rather than as stand-alone medical devices.

It is possible that some of our products will be viewed by the FDA as combination products comprised of a biologic and medical device component. We cannot be sure how the FDA will regulate our products. The FDA may require us to obtain marketing clearance and approval from multiple FDA centers. The review of combination products is often more complex and more time consuming than the review of products under the jurisdiction of only one center within the FDA.

It is possible that some of our products, including our regenerative medicine products that have been studied clinically, may be regulated by the FDA as combination products. For a combination product, the FDA must determine which center or centers within the FDA will review the product and under what legal authority the product will be reviewed. We are currently developing our regulatory strategies with respect to which regulatory pathway will be necessary to obtain clearance or approval. We believe that the biologic component of our regenerative medicine products will be reviewed by the Center for Biologics Evaluation and Research, or CBER and that the scaffold and bioreactor devices used in these applications may be reviewed by the Center for Devices and Radiological Health, or CDRH either in consultation with CBER as part of the BLA or separately as a medical device. The process of obtaining FDA marketing clearance or approval is lengthy,

8


 
 

TABLE OF CONTENTS

expensive, and uncertain, and we cannot be sure that our biologic-device combination products, or any other products, will be cleared or approved in a timely fashion, or at all. In addition, the review of combination products is often more complex and more time consuming than the review of a product under the jurisdiction of only one center within the FDA. We cannot be sure that the FDA will not select to have our combination products reviewed and regulated by only one FDA center and/or different legal authority, in which case the path to regulatory approval would be different and could be more lengthy and costly. If the FDA does not approve or clear our products in a timely fashion, or at all, our business and financial condition will be adversely affected.

In the EU, our products may be viewed as advanced therapy medicinal products, which could delay approvals and clearances and increase costs of obtaining such approvals and clearances.

In the EU, we believe that some of our products may be regulated as medical devices and may, therefore, be required to be CE marked before being placed on the EU market or put into service. The extent of testing that is required as part of the conformity assessment process to demonstrate the effectiveness of the device will depend on the classification of the device and on the extent of existing relevant data available either in scientific literature or in relation to a predicate device. In the EU, our regenerative medicine products may also be viewed as advanced therapy medicinal products or combined advanced therapy medicinal products. In such circumstances, it would be necessary to seek a marketing authorization for these products granted by the European Commission before being marketed in the EU.

The regulatory procedures leading to marketing approval of our products vary among jurisdictions and can involve substantial additional testing. Compliance with the FDA requirements does not ensure clearance or approval in other jurisdictions, and the ability to legally market our products in any one foreign country does not ensure clearance, or approval by regulatory authorities or the agreement of a notified body in other foreign jurisdictions. The foreign regulatory process leading to the marketing of the products may include all of the risks associated with obtaining FDA approval in addition to other risks. In addition, the time required to comply with foreign regulations and market products may differ from that required to obtain FDA approval, and we may not obtain foreign approval or clearance on a timely basis, if at all. We may not be able to file for regulatory clearances, approvals, or to comply with the EU requirements necessary to affix the CE mark and may not receive necessary clearances or approvals to commercialize our products in any foreign market.

Risks Associated with Clinical Trials

Clinical trials necessary to support a PMA application, a BLA license, a marketing authorization, or a CE mark for our products will be expensive and will require the enrollment of sufficient patients to adequately demonstrate safety and effectiveness for the product’s target populations. Suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any products and will adversely affect our business, operating results and prospects.

In the U.S., initiating and completing clinical trials necessary to support either PMA applications or BLA licenses, and additional safety and efficacy data beyond that typically required for a 510(k) clearance for a device, will be time consuming, expensive and the outcome uncertain. Moreover, the FDA may not agree that clinical trial results support an application for the indications sought in the application for the product. In other jurisdictions such as the EU, the conduct of extensive and expensive clinical trials may also be required in order to demonstrate the quality, safety and efficacy of our products, depending on each specific product, the claims being studied, and the target condition or disease. The outcome of these clinical trials, which can be expensive and are heavily regulated, will also be uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials.

Conducting successful clinical trials will require the enrollment of a sufficient number of patients to support each trial’s claims, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomfort and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion

9


 
 

TABLE OF CONTENTS

criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our products, or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomfort. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to investigational products.

Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support clearance and approval. Further, the FDA and foreign regulatory authorities may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. In addition, despite considerable time and expense invested in our clinical trials, the FDA and foreign regulatory authorities may not consider our data adequate to demonstrate safety and efficacy. Although FDA regulations allow submission of data from clinical trials outside the U.S., there can be no assurance that such data will be accepted or that the FDA will not apply closer scrutiny to such data. Increased costs and delays necessary to generate appropriate data, or failures in clinical trials could adversely affect our business, operating results and prospects. In the U.S., clinical studies for the company's products may be reviewed either under the Investigational Device Exemptions, or IDE pathway (for medical devices) or through the Investigational New Drug, or IND, pathway for biologics or combination products. The first regenerated trachea transplant approved in the U.S. using our bioreactor was approved under the IND pathway, but it has not yet been performed. Future FDA review under the IDE, IND, or both pathways, depending on the products, proposed study design, and study populations, is possible. In the EU, if the regulatory classification of our products is rejected by the ethics committee or competent authority reviewing our request for a positive opinion, we may be required to prepare a new study protocol reflecting a different classification. This process would be costly and time consuming.

If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

We do not have the ability to independently conduct our preclinical and clinical trials for our products and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to seek or obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at all. Our business, operating results and prospects may also be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that the FDA, foreign competent authorities or notified bodies will agree with our conclusions regarding them. Although we have obtained some positive results from the use of our bioreactors for trachea transplants performed to date, we may not see positive results when the bioreactors, or our scaffolds or other technologies undergo clinical testing in humans in the future. Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our products are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our clinical trials

10


 
 

TABLE OF CONTENTS

will delay the filing of our product submissions and, ultimately, our ability to commercialize our products and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product’s profile. In addition, our current clinical experience and clinical trial for trachea transplant involves a small patient population. Because of the small sample size, the results may not be indicative of future results.

Risk Associated with Product Marketing

Even if our products are cleared or approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

Any product for which we obtain clearance or approval in the U.S. or the EU, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections by the FDA and other domestic and foreign regulatory authorities or notified bodies. In particular, we and our suppliers are required to comply with the FDA’s Quality System Regulations, or QSR, and Good Manufacturing Practices, or GMPs, for our medical device products, and International Standards Organization, or ISO, regulations for the manufacture of our products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain clearance or approval. Manufacturing may also be subject to controls by the FDA for parts of the system or combination products that the FDA may find are controlled by the biologics regulations. Equivalent regulatory obligations apply in foreign jurisdictions. Regulatory authorities, such as the FDA, the competent authorities of the EU Member States, the European Medicines Agency and notified bodies, enforce the QSR, GMP and other applicable regulations in the U.S. and in foreign jurisdictions through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory authorities or notified bodies in the U.S. or in foreign jurisdictions, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions:

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications for repair, replacement, refunds;
recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for 510(k) clearance or premarket approval of products or modified products;
withdrawing 510(k) clearances, PMA approvals or BLAs that have already been granted;
withdrawal of the marketing authorization granted by the European Commission or delay in obtaining such marketing authorization;
withdrawal of the CE Certificates of Conformity granted by the notified body or delay in obtaining these certificates;
refusal to grant export approval for our products; and
criminal prosecution.

Postmarket enforcement actions can generate adverse commercial consequences.

Even if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be marketed and reduce our potential to successfully commercialize the product and generate revenue from the product. If the FDA or a foreign regulatory authority determines that our promotional materials, labeling, training or other marketing or educational activities constitute promotion of an unapproved use, it could request that we cease or modify our

11


 
 

TABLE OF CONTENTS

training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

Extensive governmental regulations that affect our business are subject to change, and we could be subject to penalties and could be precluded from marketing our products and technologies if we fail to comply with new regulations and requirements.

As a manufacturer and marketer of medical devices, we are subject to extensive regulation that is subject to change. In March 2010, President Obama signed into law a legislative overhaul of the U.S. healthcare system, known as the Patient Protection and Affordable Care Act of 2010, as amended by the Healthcare and Education Affordability Reconciliation Act of 2010, or the PPACA, which may have far-reaching consequences for most healthcare companies, including medical device companies like us. The PPACA could substantially change the structure of the health insurance system and the methodology for reimbursing medical services, laboratory tests, drugs and devices. These structural changes, as well as those relating to proposals that may be made in the future to change the health care system, could entail modifications to the existing system of private payors and government programs, as well as implementation of measures to limit or eliminate payments for some medical procedures and treatments or subject the pricing of medical products to government control. Government and other third-party payors increasingly attempt to contain health care costs by limiting both coverage and the level of payments of newly approved health care products. In some cases, they may also refuse to provide any coverage of uses of approved products for disease indications other than those for which the regulatory authorities have granted marketing approval. Governments may adopt future legislative proposals and federal, state, foreign or private payors for healthcare goods and services may take action to limit their payments for goods and services.

In the EU, on September 26, 2012, the European Commission proposed a revision of the legislation currently governing medical devices. If adopted by the European Parliament and the Council in their present form, these proposals, which may apply from 2015 or 2016, will impose stricter requirements on medical device manufacturers. Moreover, the supervising competences of the competent authorities of the EU Member States and the notified bodies will be strengthened. The regulation of advanced therapy medicinal products is also in continued development in the EU, with the European Medicines Agency publishing new clinical or safety guidelines concerning advanced therapy medicinal products on a regular basis.

Any of these regulatory changes and events could limit our ability to form collaborations and our ability to commercialize our products, and if we fail to comply with any such new or modified regulations and requirements it could adversely affect our business, operating results and prospects.

If we fail to complete the required IRS forms for exemptions, make timely semi-monthly payments of collected excise taxes, or submit quarterly reports as required by the Medical Device Excise Tax, we may be subject to penalties, such as Section 6656 penalties for any failure to make timely deposits.

Section 4191 of the Internal Revenue Code, enacted by Section 1405 of the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (124 Stat. 1029 (2010)), in conjunction with the Patient Protection and Affordable Care Act, Public Law 111-148 (124 Stat. 119 (2010)), imposed as of January 1, 2013, an excise tax on the sale of certain medical devices. The excise tax imposed by Section 4191 is 2.3% of the price for which a taxable medical device is sold within the U.S.

12


 
 

TABLE OF CONTENTS

The excise tax will apply to future sales of any company medical device listed with the FDA under Section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. Part 807, unless the device falls within an exemption from the tax, such as the exemption governing direct retail sale of devices to consumers or for foreign sales of these devices. We will need to assess to what extent this excise tax may impact the sales price and distribution agreements under which any of our devices are sold in the U.S. We also expect general and administrative expense to increase due to the medical device excise tax. We will need to submit IRS forms applicable to relevant exemptions, make semi-monthly payments of any collected excise taxes, and make timely (quarterly) reports to the IRS regarding the excise tax. To the extent we do not comply with the requirements of the Medical Device Excise Tax we may be subject to penalties.

Financial and Operating Risks

We have not generated any revenue to date and have a history of losses since inception. We anticipate that we will incur losses for the foreseeable future. We may never achieve or sustain profitability.

We have not generated any revenue to date and, from February 2009 through September 30, 2012, have incurred losses of approximately $10.4 million. We expect to continue to experience losses in the foreseeable future due to our limited anticipated revenues and significant anticipated expenses. We do not anticipate that we will achieve meaningful revenues for the foreseeable future. In addition, we expect that we will continue to incur significant operating expenses as we continue to focus on additional research and development, preclinical testing, clinical testing and regulatory review and/or approvals or clearances of our products and technologies. As a result, we cannot predict when, if ever, we might achieve profitability and cannot be certain that we will be able to sustain profitability, if achieved.

Our products are in an early stage of development. If we are unable to develop or market any of our products, our financial condition will be negatively affected, and we may have to curtail or cease our operations.

We are in the early stage of product development. You must evaluate us in light of the uncertainties and complexities affecting an early stage medical device company. Our products require additional research and development, preclinical testing, clinical testing and regulatory review and/or approvals or clearances before marketing. In addition, we may not succeed in developing new products as an alternative to our existing portfolio of products. If we fail to successfully develop and commercialize our products, including our bioreactor and scaffold system, our financial condition may be negatively affected, and we may have to curtail or cease our operations.

We have a limited operating history and it is difficult to predict our future growth and operating results.

We have a limited operating history and limited operations and assets. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties encountered by companies in the early stage of development. As a development stage company, our development timelines have been and may continue to be subject to delay that could negatively affect our cash flow and our ability to develop or bring products to market, if at all.

Our prospects must be considered in light of inherent risks, expenses and difficulties encountered by all early stage companies, particularly companies in new and evolving markets, such as regenerative medicine. These risks include, but are not limited to, unforeseen capital requirements, delays in obtaining regulatory approvals, failure to gain market acceptance and competition from foreseen and unforeseen sources.

Our operations could be adversely affected if we are unable to raise or obtain needed funding.

Substantial time, financial and other resources will be required to complete ongoing development and clinical testing of our products. Regulatory efforts and collaborative arrangements will also be necessary for our products that are currently under development and testing in order for them to be marketed. Our revenues from operations and cash may not be sufficient over the next several years for commercialization of all of the technologies and products we are currently developing. Consequently, we may seek strategic partners for various phases of development, marketing and commercialization of products employing our technologies. Further, we cannot assure you as to the sufficiency of our resources or the time required to complete any

13


 
 

TABLE OF CONTENTS

ongoing development and clinical testing, since the extent to which we conduct such testing is dependent on resource allocation decisions that we make from time to time based on numerous financial as well as operational conditions.

In addition to development and other costs, we expect to incur capital expenditures from time to time. These capital expenditures will be influenced by our regulatory compliance efforts, our success, if any, at developing collaborative arrangements with strategic partners, our needs for additional facilities and capital equipment and the growth, if any, of our business in general. We may seek to raise necessary funds through public or private equity offerings, debt financings or strategic collaborations and licensing arrangements. We may not be able to obtain additional financing on terms favorable to us, if at all. General market conditions may make it very difficult for us to seek financing from the capital markets. Additional equity financing could result in significant dilution to our stockholders. Debt financing, if available, could result in agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures or paying dividends. In addition, in order to raise additional funds through strategic collaborations or licensing arrangements, we may be required to relinquish rights to our technologies or products. If we cannot raise funds or engage strategic partners on acceptable terms when needed, we may not be able to continue our research and development activities, develop or enhance our products, take advantage of future opportunities, grow our business or respond to competitive pressures or unanticipated requirements.

If we fail to retain key personnel, we may not be able to compete effectively, which would have an adverse effect on our operations.

Our success is highly dependent on the continued services of key management, technical and scientific personnel and collaborators. Our management and other employees may voluntarily terminate their employment at any time upon short notice. The loss of the services of any member of our senior management team, including our Chief Executive Officer and President, David Green, our Chief Financial Officer, Thomas McNaughton, and our other key scientific, technical and management personnel, may significantly delay or prevent the achievement of product development and other business objectives.

If our collaborators do not devote sufficient time and resources to successfully carry out their duties or meet expected deadlines, we may not be able to advance our products in a timely manner or at all.

We are currently collaborating with multiple academic researchers and clinicians at a variety of research and clinical institutions. Our success depends in part on the performance of our collaborators. Some collaborators may not be successful in their research and clinical trials or may not perform their obligations in a timely fashion or in a manner satisfactory to us. Typically, we cannot control the amount of resources or time our collaborators may devote to our programs or potential products that may be developed in collaboration with us. Our collaborators frequently depend on outside sources of funding to conduct or complete research and development, such as grants or other awards. In addition, our academic collaborators may depend on graduate students, medical students, or research assistants to conduct certain work, and such individuals may not be fully trained or experienced in certain areas, or they may elect to discontinue their participation in a particular research program, creating an inability to complete ongoing research in a timely and efficient manner. As a result of these uncertainties, we are unable to control the precise timing and execution of any experiments that may be conducted.

We do not have formal agreements in place with most of our collaborators, who retain the ability to pursue other research, product development or commercial opportunities that may be directly competitive with our programs. If these collaborators elect to prioritize or pursue other programs in lieu of ours, we may not be able to advance product development programs in an efficient or effective manner, if at all. If a collaborator is pursuing a competitive program and encounters unexpected financial or capability limitations, they may be motivated to reduce the priority placed on our programs or delay certain activities related to our programs. Any of these developments could harm or slow our product and technology development efforts.

In particular, we depend upon Dr. Paolo Macchiarini, the surgeon who has led all of the clinical surgeries to date using our technology. Dr. Macchiarini’s team developed the initial version of our InBreath airway bioreactor, which we have licensed from the inventors. We continue to collaborate with Dr. Macchiarini on grant proposals and product development. If Dr. Macchiarini were not available to continue to collaborate with

14


 
 

TABLE OF CONTENTS

us or perform surgeries it would materially slow development of our products. On September 27, 2012, Dr. Macchiarini was arrested in Italy for attempted fraud and extortion for allegedly attempting to persuade severely ill patients to choose private hospitals in other countries over less expensive Italian public hospitals. He was temporarily placed under house arrest and on October 15, 2012 was released from house arrest and is free to travel internationally and to perform surgeries. The case is ongoing. Dr. Macchiarini believes these charges are without merit and has, and intends to continue to, vigorously defend these charges. These allegations do not relate to any surgeries involving our products and have not prevented Dr. Macchiarini from making preparations for further transplant surgeries using our products at the Karolinska Hospital, or in the U.S. or Russia. If Dr. Macchiarini decides to terminate his collaboration with us, if the case described above consumes a significant amount of his time, or if the case prevents him from performing surgeries, our product development efforts could be adversely affected and it could cause harm to our reputation or business.

Public perception of ethical and social issues surrounding the use of cell technology may limit or discourage the use of our technologies, which may reduce the demand for our products and technologies and reduce our revenues.

Our success will depend in part upon our collaborators’ ability to develop therapeutic approaches incorporating, or discovered through, the use of cells. If regenerative medicine technology is perceived negatively by the public for social, ethical, medical or other reasons, governmental authorities in the U.S. and other countries may call for prohibition of, or limits on, cell-based technologies and other approaches to regeneration. Although the surgeons using our products have not to date used the more controversial stem cells derived from human embryos or fetuses in the human transplant surgeries using our products, claims that human-derived stem cell technologies are ineffective or unethical may influence public attitudes. The subject of cell and stem cell technologies in general has received negative publicity and aroused public debate in the U.S. and some other countries. Ethical and other concerns about such cells could materially harm the market acceptance of our products.

Our products will subject us to liability exposure.

We face an inherent risk of product liability claims, especially with respect to our products that will be used within the human body, including the scaffolds we manufacture. Product liability coverage is expensive and sometimes difficult to obtain. We may not be able to obtain or maintain insurance at a reasonable cost. We may be subject to claims for liabilities for unsuccessful outcomes of surgeries involving our products, which may include claims relating to patient death. We may also be subject to claims for liabilities relating to patients that suffer serious complications or death during or following transplants involving our products. Our current product liability coverage is $15 million per occurrence and in the aggregate. We will need to increase our insurance coverage if and when we begin commercializing any of our products. There can be no assurance that existing insurance coverage will extend to other products in the future. Any product liability insurance coverage may not be sufficient to satisfy all liabilities resulting from product liability claims. A successful claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable items, if at all. If claims against us substantially exceed our coverage, then our business could be adversely impacted. Regardless of whether we are ultimately successful in any product liability litigation, such litigation could consume substantial amounts of our financial and managerial resources and could result in, among others:

significant awards against us;
substantial litigation costs;
injury to our reputation and the reputation of our products;
withdrawal of clinical trial participants; and
adverse regulatory action.

Any of these results would substantially harm our business.

15


 
 

TABLE OF CONTENTS

If restrictions on reimbursements or other conditions imposed by payors limit our customers’ actual or potential financial returns on our products, our customers may not purchase our products or may reduce their purchases.

Our customers’ willingness to use our products will depend in part on the extent to which coverage for these products is available from government payors, private health insurers and other third-party payors. These payors are increasingly challenging the price of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved treatments and products in the regenerative medicine field, and coverage and adequate payments may not be available for these treatments and products. In addition, third-party payors may require additional clinical trial data to establish or continue reimbursement coverage. These clinical trials, if required, could take years to complete and could be expensive. There can be no assurance that the payors will agree to continue reimbursement or provide additional coverage based upon these clinical trials. Failure to obtain adequate reimbursement would result in reduced sales of our products.

We depend upon a single-source supplier for the hardware and software used for our organ bioreactor control and acquisition system. The loss of this supplier, or future single-source suppliers we may rely on, or their failure to provide us with an adequate supply of their products or services on a timely basis, could adversely affect our business.

We currently have a single supplier for the hardware and software that we use for our organ bioreactor control and acquisition systems. We may also rely on other single-source suppliers for critical components of our products in the future. If we were unable to acquire hardware or software or other products or services from applicable single-source suppliers, we could experience a delay in developing and manufacturing our products.

We use and generate hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive.

Our research, development and manufacturing involves the controlled use of hazardous chemicals, and we may incur significant costs as a result of the need to comply with numerous laws and regulations. For example, certain volatile organic laboratory chemicals we use, such as fluorinated hydrocarbons, must be disposed of as hazardous waste. We are subject to laws and regulations enforced by the FDA, foreign health authorities and other regulatory requirements, including the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other current and potential federal, state, local and foreign laws and regulations governing the use, manufacture, storage, handling and disposal of our products, materials used to develop and manufacture our products, and resulting waste products. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages that result and any such liability could exceed our resources.

Our products are novel and will require market acceptance.

Even if we receive regulatory approvals for the commercial use of our products, their commercial success will depend upon acceptance by physicians, patients, third party payers such as health insurance companies and other members of the medical community. Market acceptance of our products is also dependent upon our ability to provide acceptable evidence and the perception of the positive characteristics of our products relative to existing or future treatment methods, including their safety, efficacy and/or other positive advantages. If our products fail to gain market acceptance, we may be unable to earn sufficient revenue to continue our business. Market acceptance of, and demand for, any product that we may develop and commercialize will depend on many factors, both within and outside of our control. If our products do not become widely accepted, our business, financial condition and results of operations would be materially and adversely affected.

Our long-term growth depends on our ability to develop products for other organs.

Our growth strategy includes expanding the use of our products in treatments pertaining to organs other than the trachea, such as lungs, gastrointestinal tract, heart valves and heart. These other organs are more complex than the trachea. There is no assurance that we will be able to successfully apply our technologies to these other more complex organs, which will limit our expected growth.

16


 
 

TABLE OF CONTENTS

Our success will depend partly on our ability to operate without infringing on, or misappropriating, the intellectual property or confidentiality rights of others.

We may be sued for infringing on the intellectual property or confidentiality rights of others, including the patent rights, trademarks and trade names and confidential information of third parties. For example, we have sublicensed certain rights pertaining to our use of the mark Harvard Apparatus from Harvard Bioscience, including the use in our corporate name. Harvard Bioscience has licensed the rights to such mark from Harvard University. If the license to Harvard Bioscience or our sublicense were terminated, it could have an adverse effect on us. We have also received correspondence from legal counsel to Nanofiber Solutions, Inc., or NFS, claiming that in developing our scaffold product and related intellectual property, we may have committed misappropriation, unauthorized use and disclosure of confidential information, and possible infringement of intellectual property rights of NFS. Intellectual property and related litigation is costly and the outcome is uncertain. If we do not prevail in any such intellectual property or related litigation, in addition to any damages we might have to pay, we could be required to stop the infringing activity, or obtain a license to or design around the intellectual property or confidential information in question. If we are unable to obtain a required license on acceptable terms, or are unable to design around any third party patent, we may be unable to sell some of our products and services, which could result in reduced revenue.

We may be involved in lawsuits to protect or enforce our patents that would be expensive and time consuming.

In order to protect or enforce our patent rights, we may initiate patent litigation against third parties. We may also become subject to interference proceedings conducted in the patent and trademark offices of various countries to determine the priority of inventions. The defense and prosecution, if necessary, of intellectual property suits, interference proceedings and related legal and administrative proceedings would be costly and divert our technical and management personnel from their normal responsibilities. We may not prevail in any of these suits should they occur. An adverse determination of any litigation or defense proceedings could put our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of being rejected and patents not being issued.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. For example, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments in the litigation. Securities analysts or investors may perceive these announcements to be negative, which could cause the market price of our stock to decline.

If we are unable to effectively protect our intellectual property, third parties may use our technology, which would impair our ability to compete in our markets.

Our continued success will depend significantly on our ability to obtain and maintain meaningful patent protection for certain of our products throughout the world. Patent law relating to the scope of claims in the regenerative medicine and medical device fields in which we operate is still evolving. The degree of future protection for our proprietary rights is uncertain. We rely on patents to protect a significant part of our intellectual property and to enhance our competitive position. However, our presently pending or future patent applications may not be accepted and patents might not be issued, and any patent previously issued to us may be challenged, invalidated, held unenforceable or circumvented. Furthermore, the claims in patents which have been issued or which may be issued to us in the future may not be sufficiently broad to prevent third parties from producing competing products similar to our products. We also rely on trademarks and trade names in our business. The laws of various foreign countries in which we compete may not protect our intellectual property to the same extent as do the laws of the U.S. If we fail to obtain adequate patent protection for our proprietary technology, our ability to be commercially competitive could be materially impaired.

In addition to patent protection, we also rely on protection of trade secrets, know-how and confidential and proprietary information. To maintain the confidentiality of trade-secrets and proprietary information, we generally seek to enter into confidentiality agreements with our employees, consultants and strategic partners upon the commencement of a relationship. However, we may not be able to obtain these agreements in all

17


 
 

TABLE OF CONTENTS

circumstances in part due to local regulations. In the event of unauthorized use or disclosure of this information, these agreements, even if obtained, may not provide meaningful protection for our trade-secrets or other confidential information. In addition, adequate remedies may not exist in the event of unauthorized use or disclosure of this information. The loss or exposure of our trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect on our operating results, financial condition and future growth prospects.

Our competitors and potential competitors may have greater resources than we have and may develop products and technologies that are more effective or commercially attractive than our products and technologies or may develop competing relationships with our key collaborators.

We expect to compete with multiple pharmaceutical, biotechnology, medical device and scientific research product companies. Companies working in competing areas include, among others, Aastrom Biosciences, Aldagen, BioTime, Baxter International, Inc., Bose Corporation, Celgene, Cytori Therapeutics, E. I. du Pont de Nemours and Company, Genzyme (acquired by Sanofi-aventis), Harvest Technologies, Mesoblast, Nanofiber Solutions, Organovo, Osiris Therapeutics, Smiths Medical, Tengion, Tissue Genesis, Inc., Tissue Growth Technologies, Transmedics, United Therapeutics and W.L. Gore and Associates. Many of our competitors and potential competitors have substantially greater financial, technological, research and development, marketing, and personnel resources than we do. We cannot, with any accuracy, forecast when or if these companies are likely to bring regenerative medicine medical devices to market for indications that we are also pursuing. Many of these potential competitors may be further along in the process of product development and also operate large, company-funded research and development programs. It is also possible that some of our potential customers could engineer their own solutions to the problem of accurate injections.

We expect that other products will compete with our current and future products based on efficacy, safety, cost, and intellectual property positions. While we believe that these will be the primary competitive factors, other factors include obtaining marketing exclusivity under certain regulations, including the Orphan Drug Act, availability of supply, manufacturing, marketing and sales expertise and capability, and reimbursement coverage. Our competitors may develop or market products that are more effective or commercially attractive than our current or future products and may also develop competing relationships with our key collaborators. In addition, we may face competition from new entrants into the field. We may not have the financial resources, technical expertise or marketing, distribution or support capabilities to compete successfully in the future. The effects of any such actions of our competitors may have a material adverse effect on our business, operating results and financial condition.

If we do not successfully manage our growth, our business goals may not be achieved.

To manage growth, we will be required to continue to improve existing, and implement additional, operational and financial systems, procedures and controls, and hire, train and manage additional employees. Our current and planned personnel, systems, procedures and controls may not be adequate to support our anticipated growth and we may not be able to hire, train, retain, motivate and manage required personnel. Competition for qualified personnel in the technology and regenerative medicine area is intense, and we operate in several geographic locations where labor markets are particularly competitive, including Boston, Massachusetts, where demand for personnel with these skills is extremely high and is likely to remain high. As a result, competition for qualified personnel is intense and the process of hiring suitably qualified personnel is often lengthy and expensive, and may become more expensive in the future. If we are unable to hire and retain a sufficient number of qualified employees or otherwise manage our growth effectively, our ability to conduct and expand our business could be seriously reduced.

We are exposed to a variety of risks relating to our international sales and operations, including fluctuations in exchange rates, local economic conditions and delays in collection of accounts receivable.

We intend to generate significant revenues outside the U.S. in multiple foreign currencies including Euros, British pounds, and in U.S. dollar-denominated transactions conducted with customers who generate revenue in currencies other than the U.S. dollar. For those foreign customers who purchase our products in U.S. dollars, currency fluctuations between the U.S. dollar and the currencies in which those customers do business may have a negative impact on the demand for our products in foreign countries where the U.S. dollar has increased in value compared to the local currency.

18


 
 

TABLE OF CONTENTS

Since we have operations based outside the U.S. and we generate revenues and incur operating expenses in multiple foreign currencies, we experience currency exchange risk with respect to those foreign currency-denominated revenues and expenses.

We cannot predict the consolidated effects of exchange rate fluctuations upon our future operating results because of the number of currencies involved, the variability of currency exposure and the potential volatility of currency exchange rates. Our international operations subject us to laws regarding sanctioned countries, entities and persons, customs, import-export, laws regarding transactions in foreign countries, the U.S. Foreign Corrupt Practices Act and local anti-bribery and other laws regarding interactions with healthcare professionals. Among other things, these laws restrict, and in some cases prohibit, U.S. companies from directly or indirectly selling goods, technology or services to people or entities in certain countries. In addition, these laws require that we exercise care in structuring our sales and marketing practices in foreign countries.

Local economic conditions, legal, regulatory or political considerations, disruptions from strikes, the effectiveness of our sales representatives and distributors, local competition and changes in local medical practice could also affect our sales to foreign markets. Relationships with customers and effective terms of sale frequently vary by country, often with longer-term receivables than are typical in the U.S.

Risks Related To Separation

As long as Harvard Bioscience controls us, your ability to influence matters requiring stockholder approval will be extremely limited.

Harvard Bioscience currently owns 100% of our issued and outstanding common stock. After this offering, Harvard Bioscience will continue to own at least 80% of our issued and outstanding common stock. As long as Harvard Bioscience owns a majority of our outstanding common stock, Harvard Bioscience will have the ability to take stockholder action without the vote of any other stockholder, and investors in this offering will not be able to affect the outcome of any stockholder vote during this period. As a result, Harvard Bioscience will have the ability to control all matters affecting us, including:

the composition of our board of directors and, through our board of directors, any determination with respect to our business plans and policies, including the appointment and removal of our officers;
any determinations with respect to mergers and other business combinations;
our acquisition or disposition of assets;
our financing activities;
changes to, and waivers of Harvard Bioscience’s obligations under, the agreements providing for our separation from Harvard Bioscience;
the allocation of business opportunities that may be suitable for us and Harvard Bioscience;
the payment of dividends on our common stock;
certain determinations with respect to our tax returns; and
the number of shares of our common stock available for issuance under our equity plans.

Harvard Bioscience’s voting control may discourage transactions involving a change of control of us, including transactions in which you as a holder of our common stock might otherwise receive a premium for your shares over the then-current market price. Harvard Bioscience is not prohibited from selling a controlling interest in us to a third party and may do so without your approval and without providing for a purchase of your common stock. Accordingly, your shares of our common stock may be worth less than they would be if Harvard Bioscience did not maintain voting control over us.

This effective control on all matters relating to our business and operations could also eliminate the possibility of stockholders changing management in the event that stockholders did not agree with the conduct of officers and directors. Additionally, stockholders would potentially not be able to obtain the necessary stockholder vote

19


 
 

TABLE OF CONTENTS

to affect any change in the course of our business. This lack of stockholder control could prevent the stockholders from removing any of our directors who are not managing our company with sufficient skill to make it profitable, which could prevent us from becoming profitable, and in turn cause investors to lose all or part of their investment.

We may be unable to achieve some or all of the benefits that we expect to achieve from our separation from Harvard Bioscience.

As a stand-alone, independent public company, we believe that our business will benefit from, among other things, allowing our management to design and implement corporate policies and strategies that are based primarily on the characteristics of our business, allowing us to focus our financial resources wholly on our own operations and implement and maintain a capital structure designed to meet our own specific needs. By separating from Harvard Bioscience there is a risk that our company may be more susceptible to market fluctuations and other adverse events than we would have been were we still a part of Harvard Bioscience. We may not be able to achieve some or all of the benefits that we expect to achieve as a stand-alone, independent regenerative medicine company or such benefits may be delayed or may not occur at all. For example, there can be no assurance that analysts and investors will place a greater value on our company as a stand-alone regenerative medicine company than on our business as a part of Harvard Bioscience.

We have no operating history as an independent company, and we may be unable to make the changes necessary to operate as an independent public company.

Prior to the separation, our business was operated by Harvard Bioscience as part of its broader corporate organization rather than as a stand-alone company. Harvard Bioscience assisted us by providing financing and certain corporate functions. Following the separation, Harvard Bioscience will have no obligation to provide assistance to us other than the interim transitional services which will be provided by Harvard Bioscience. These transitional services include, among other things, financial and managerial services. Because our business has not been operated as an independent company, we cannot assure you that we will be able to successfully implement the changes necessary to operate independently or that we will not incur additional costs operating independently that would have a negative effect on our business, results of operations or financial condition.

Your investment in our common stock may be adversely affected if Harvard Bioscience does not spin off the shares of our common stock owned by Harvard Bioscience.

Harvard Bioscience has advised us that following the completion of this offering and the expiration or waiver of the applicable lock-up period, it intends to spin off all of the remaining shares of our common stock that it owns to its stockholders as soon as practicable. Harvard Bioscience expects that the spin-off will occur on or after the date that is four months following completion of this offering. The spin-off will be subject to the satisfaction or waiver of certain conditions. Harvard Bioscience may decide not to complete the spin-off if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the spin-off is not in the best interests of Harvard Bioscience or its stockholders. Unless and until the spin-off occurs, we will face the risks discussed in this prospectus relating to Harvard Bioscience, including its control of us and potential conflicts of interest between Harvard Bioscience and us. In addition, if a spin-off does not occur, the liquidity of the market for our common stock may be constrained for as long as Harvard Bioscience continues to hold a significant position in our common stock. A lack of liquidity in the market for our common stock may adversely affect our stock price.

If the separation and distribution, together with certain related transactions, does not qualify as a transaction that is generally tax-free for U.S. federal income tax purposes, Harvard Bioscience could be subject to significant tax liability and, in certain circumstances, we could be required to indemnify Harvard Bioscience for material taxes pursuant to indemnification obligations under the tax sharing agreement.

Harvard Bioscience has applied for a private letter ruling from the IRS substantially to the effect that, among other things, the separation and distribution, together with certain related transactions, will qualify as a transaction that is generally tax-free for U.S. federal income tax purposes under Sections 355 and 368(a)(1)(D) of the Code. Harvard Bioscience has advised us that it does not currently intend to complete the distribution if

20


 
 

TABLE OF CONTENTS

it has not obtained the IRS private letter ruling substantially to the effect that the separation and distribution, together with certain related transactions, will so qualify. The private letter ruling and the tax opinion that Harvard Bioscience expects to receive from Burns & Levinson LLP, special counsel to Harvard Bioscience, will rely on certain representations, assumptions and undertakings, including those relating to the past and future conduct of our business, and neither the private letter ruling nor the opinion would be valid if such representations, assumptions and undertakings were incorrect. Moreover, the private letter ruling does not address all the issues that are relevant to determining whether the distribution will qualify for tax-free treatment. Notwithstanding the private letter ruling and opinion, the IRS could determine the distribution should be treated as a taxable transaction for U.S. federal income tax purposes if, among other reasons, it determines any of the representations, assumptions or undertakings that were included in the request for the private letter ruling are false or have been violated or if it disagrees with the conclusions in the opinion that are not covered by the IRS ruling.

If the distribution fails to qualify for tax-free treatment, in general, Harvard Bioscience would be subject to tax as if it had sold our common stock in a taxable sale for its fair market value, and Harvard Bioscience stockholders who receive shares of our common stock in the distribution would be subject to tax as if they had received a taxable distribution equal to the fair market value of such shares.

Under the tax sharing agreement between Harvard Bioscience and us, we would generally be required to indemnify Harvard Bioscience against any tax resulting from the distribution to the extent that such tax resulted from (i) an acquisition of all or a portion of our stock or assets, whether by merger or otherwise, (ii) other actions or failures to act by us, or (iii) any of our representations or undertakings being incorrect or violated. For a more detailed discussion, see “Certain Relationships and Related Transactions — Agreements with Harvard Bioscience — Tax Sharing Agreement.” Our indemnification obligations to Harvard Bioscience and its subsidiaries, officers and directors are not limited by any maximum amount. If we are required to indemnify Harvard Bioscience or such other persons under the circumstances set forth in the tax sharing agreement, we may be subject to substantial liabilities.

We may not be able to engage in desirable strategic or capital-raising transactions following the distribution. In addition, under some circumstances, we could be liable for adverse tax consequences resulting from engaging in significant strategic or capital-raising transactions.

To preserve the tax-free treatment to Harvard Bioscience of the separation and distribution, for the two-year period following the distribution we may be limited, except in specified circumstances, from:

entering into any transaction pursuant to which all or a portion of our stock would be acquired, whether by merger or otherwise;
issuing equity securities beyond certain thresholds;
repurchasing our common stock;
ceasing to actively conduct our regenerative medicine business; and
taking or failing to take any other action that prevents the separation and distribution and related transactions from being tax-free.

These restrictions may limit our ability to pursue strategic transactions or engage in new business or other transactions that may maximize the value of our business.

We may be unable to make, on a timely or cost-effective basis, the changes necessary to operate as an independent company, and we may experience increased costs after the separation or as a result of the separation.

Following the completion of our separation, Harvard Bioscience will be contractually obligated to provide to us only those services specified in the transition services agreement and the other agreements we enter into with Harvard Bioscience in preparation for the separation. The transition services agreement provides for services to be provided for various time frames of limited length, ranging from six to 12 months from the date of our separation. We may be unable to replace in a timely manner or on comparable terms the services or other benefits that Harvard Bioscience previously provided to us that are not specified in the transition

21


 
 

TABLE OF CONTENTS

services agreement or the other agreements. Also, upon the expiration of the terms of the required services under the transition services agreement or other agreements, such services will be provided internally or by unaffiliated third parties, and we expect that in some instances, we will incur higher costs to obtain such services than we incurred under the terms of such agreements. We anticipate that we will incur additional incremental expenses associated with being an independent, public company. These additional pretax expenses are estimated to be $     million for the year ending December 31, 2013. In addition, if Harvard Bioscience does not continue to perform effectively the transition services and the other services that are called for under the transition services agreement and other agreements, we may not be able to operate our business effectively and our operating results could be adversely affected. Furthermore, after the expiration of the terms of the required services under transition services agreement and the other agreements, we may be unable to replace in a timely manner or on comparable terms the services specified in such agreements.

Prior to our separation, we have utilized the executive management team and administrative resources of Harvard Bioscience. Many daily functions have been performed by Harvard Bioscience, including those related to SEC filings and auditing and review by accountants of required financial statements, which will become our responsibility after the separation. In addition, there will be a time period during which such new personnel will have to learn the required systems for these functions. The lack of these relationships and resources may harm our operating results, financial condition and our ability to raise any required debt or equity funding.

Our historical and pro forma financial information is not necessarily representative of the results we would have achieved as a separate publicly traded company and may not be a reliable indicator of our future results.

The historical financial and pro forma financial information we have included in this prospectus may not reflect what our results of operations, financial position and cash flows would have been had we been an independent publicly traded company during the periods presented or what our results of operations, financial position and cash flows will be in the future when we are an independent company. This is primarily because:

our historical and financial information reflects allocations for services historically provided to us by Harvard Bioscience, which allocations may not reflect the costs we will incur for similar services in the future as an independent company; and
our historical and financial information does not reflect changes that we expect to incur in the future as a result of our separation from Harvard Bioscience, including changes in the cost structure, personnel needs, financing and operations of the contributed business as a result of the separation from Harvard Bioscience and from reduced economies of scale.

Following the separation and distribution, we also will be responsible for the additional costs associated with being an independent public company, including costs related to corporate governance and listed and registered securities. Therefore, our financial statements may not be indicative of our future performance as an independent company. For additional information about our past financial performance and the basis of presentation of our financial statements, please see “Selected Historical Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the notes thereto included elsewhere in this prospectus.

We may have received better terms from unaffiliated third parties than the terms we received in our agreements with Harvard Bioscience.

The agreements related to our separation from Harvard Bioscience, including the separation and distribution agreement, tax sharing agreement, transition services agreement and the other agreements, were negotiated in the context of our separation from Harvard Bioscience while we were still part of Harvard Bioscience and, accordingly, may not reflect terms that would have resulted from arm’s-length negotiations among unaffiliated third parties. The terms of the agreements we negotiated in the context of our separation related to, among other things, allocation of assets, liabilities, rights, indemnifications and other obligations among Harvard Bioscience and us. We may have received better terms from third parties because third parties may have competed with each other to win our business. Some of our board members are also members of the Harvard Bioscience board. See “Certain Relationships and Related Party Transactions.”

22


 
 

TABLE OF CONTENTS

The ownership by our executive officers and some of our directors of shares of common stock, options, or other equity awards of Harvard Bioscience, as well as the continued roles of our executive officers and certain directors with Harvard Bioscience prior to and after the planned distribution of our common stock by Harvard Bioscience, may create, or may create the appearance of, conflicts of interest.

The ownership by our executive officers and some of our directors of shares of common stock, options, or other equity awards of Harvard Bioscience may create, or may create the appearance of, conflicts of interest. Because of their current or former positions with Harvard Bioscience, certain of our executive officers, and some of our directors, own shares of Harvard Bioscience common stock, options to purchase shares of Harvard Bioscience common stock or other equity awards. The individual holdings of common stock, options to purchase common stock of Harvard Bioscience or our company or other equity awards, may be significant for some of these persons compared to such persons’ total assets. Ownership by our directors and officers, after our separation, of common stock or options to purchase common stock of Harvard Bioscience, or any other equity awards, creates, or, may create the appearance of, conflicts of interest when these directors and officers are faced with decisions that could have different implications for Harvard Bioscience than the decisions have for us. In addition, certain of our directors and executive officers will remain in service for or employed by both our company as well as Harvard Bioscience following any consummation of this offering. Our executive officers will remain employed by Harvard Bioscience until Harvard Bioscience completes its planned distribution of our common stock to its stockholders and certain of our directors are expected to remain on the board of directors of Harvard Bioscience following the planned distribution. The continued service or employment relationships at both companies creates, or, may create the appearance of, conflicts of interest when these directors or executive officers are faced with decisions that could have different implications for Harvard Bioscience than the decisions have for us.

Third parties may seek to hold us responsible for liabilities of Harvard Bioscience that we did not assume in our agreements.

In connection with our separation from Harvard Bioscience, Harvard Bioscience has generally agreed to retain all liabilities that did not historically arise from our business. Third parties may seek to hold us responsible for Harvard Bioscience’s retained liabilities. Under our agreements with Harvard Bioscience, Harvard Bioscience has agreed to indemnify us for claims and losses relating to these retained liabilities. However, if those liabilities are significant and we are ultimately liable for them, we cannot assure you that we will be able to recover the full amount of our losses from Harvard Bioscience.

Any disputes that arise between us and Harvard Bioscience with respect to our past and ongoing relationships could harm our business operations.

Disputes may arise between Harvard Bioscience and us in a number of areas relating to our past and ongoing relationships, including:

intellectual property, technology and business matters, including failure to make required technology transfers and failure to comply with non-compete provisions applicable to Harvard Bioscience and us;
labor, tax, employee benefit, indemnification and other matters arising from our separation from Harvard Bioscience;
distribution and supply obligations;
employee retention and recruiting;
business combinations involving us;
sales or distributions by Harvard Bioscience of all or any portion of its ownership interest in us;
the nature, quality and pricing of transitional services Harvard Bioscience has agreed to provide us; and
business opportunities that may be attractive to both Harvard Bioscience and us.

23


 
 

TABLE OF CONTENTS

We may not be able to resolve any potential conflicts, and even if we do, the resolution may be less favorable than if we were dealing with an unaffiliated party.

The agreements we have entered into with Harvard Bioscience may be amended upon agreement between the parties. While we are controlled by Harvard Bioscience, Harvard Bioscience may be able to require us to agree to amendments to these agreements that may be less favorable to us than the original terms of the agreements.

Risks Relating To Our Common Stock

There is no existing market for our common stock and a trading market that will provide you with adequate liquidity may not develop for our common stock.

There is currently no public market for our common stock. We cannot predict the extent to which investor interest in our company will lead to the development of a trading market in our common stock, or how liquid that market might be. If an active market does not develop, you may have difficulty selling your shares of our common stock. The initial public offering price of our common stock will be determined by the negotiations between us and the representatives of the underwriters and may not be indicative of prices that will prevail in the open market following the completion of this offering.

Our revenues, operating results and cash flows may fluctuate in future periods and we may fail to meet investor expectations, which may cause the price of our common stock to decline.

Variations in our quarterly and year-end operating results are difficult to predict and may fluctuate significantly from period to period. If our sales or operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. In addition to the other factors discussed under these “Risk Factors,” specific factors that may cause fluctuations in our operating results include:

demand and pricing for our products;
government or private healthcare reimbursement policies;
physician and patient acceptance of any of our current or future products;
manufacturing stoppages or delays;
introduction of competing products;
our operating expenses which fluctuate due to growth of our business; and
timing and size of any new product or technology acquisitions we may complete.

Once our common stock begins trading, the market price of our shares may fluctuate widely.

We cannot predict the prices at which our common stock may trade after this offering or after the planned distribution of our common stock by Harvard Bioscience. The market price of our common stock may fluctuate widely, depending upon many factors, some of which may be beyond our control, including:

the potential spin-off by Harvard Bioscience of shares of our common stock, including that our business profile and market capitalization may not fit the investment objectives of Harvard Bioscience stockholders, and as a result, Harvard Bioscience stockholders may sell our shares after the distribution;
the success or failure of surgeries and procedures involving the use our products;
the success and costs of preclinical and clinical testing and obtaining regulatory approvals or clearances for our products;
a shift in our investor base;
our quarterly or annual results of operations, or those of other companies in our industry;
actual or anticipated fluctuations in our operating results due to factors related to our business;

24


 
 

TABLE OF CONTENTS

changes in accounting standards, policies, guidance, interpretations or principles;
announcements by us or our competitors of significant acquisitions, dispositions or intellectual property developments or issuances;
the failure to maintain our NASDAQ listing or failure of securities analysts to cover our common stock after the distribution;
changes in earnings estimates by securities analysts or our ability to meet those estimates;
the operating and stock price performance of other comparable companies;
overall market fluctuations; and
general economic conditions.

Stock markets in general have experienced volatility that has often been unrelated to the operating performance of a particular company. These broad market fluctuations may adversely affect the trading price of our common stock.

Substantial sales of common stock may occur following the planned distribution by Harvard Bioscience, which could cause our stock price to decline.

The shares of our common stock that Harvard Bioscience distributes to its stockholders generally will be able to be sold immediately in the public market following the planned distribution. Some Harvard Bioscience stockholders, including possibly some of its large stockholders, may sell our common stock received in the distribution for reasons such as that our business profile or market capitalization as an independent company does not fit their investment objectives. The sales of significant amounts of our common stock, or the perception in the market that this will occur, may result in a decline in the price of our common stock.

Your percentage ownership will be diluted in the future.

Your percentage ownership will be diluted in the future because of equity awards that we expect will be granted to our directors, officers and employees and the accelerated vesting of other equity awards. Prior to the completion of this offering, our board of directors and Harvard Bioscience will have approved our 2013 Equity Incentive Plan, which provides for the grant of equity-based awards, including restricted stock, restricted stock units, stock options, stock appreciation rights and other equity-based awards to our directors, officers and other employees, advisors and consultants. In addition, your percentage ownership will be diluted by our issuance of common stock following the exercise of options, or vesting of restricted stock units, we expect to issue pertaining to the adjustment and conversion of outstanding Harvard Bioscience equity awards upon the effectiveness of the spin-off of our company.

Our costs will increase significantly as a result of operating as a public company, and our management will be required to devote substantial time to complying with public company regulations.

We have historically operated our business as a division of a public company. As a public company with separate SEC reporting, regulatory, and stock exchange listing requirements, we will incur additional legal, accounting, compliance, and other expenses that we have not incurred historically. After completion of this offering, we will be obligated to file with the SEC annual and quarterly information and other reports that are specified in Section 13 and other sections of the Securities Exchange Act of 1934, as amended, and therefore will need to have the ability to prepare financial statements that are compliant with all SEC reporting requirements on a timely basis. In addition, we will be subject to other reporting and corporate governance requirements, including certain requirements of the NASDAQ Stock Market and certain provisions of the Sarbanes-Oxley Act and its associated regulations, which will impose significant compliance obligations upon us.

Sarbanes-Oxley and the Dodd-Frank Wall Street Reform and the Consumer Protection Act of 2010, as well as new rules subsequently implemented by the SEC and the NASDAQ Stock Market, have increased regulation of, and imposed enhanced disclosure and corporate governance requirements on, public companies. Our efforts to comply with evolving laws, regulations, and standards in this regard are likely to result in increased

25


 
 

TABLE OF CONTENTS

marketing, selling, and administrative expenses, as well as a diversion of management’s time and attention from revenue-generating activities to compliance activities. These changes will require a significant commitment of additional resources. We may not be successful in implementing these requirements, and implementing them could materially adversely affect our business, results of operations, and financial condition. We also expect these recent regulations to increase our legal and financial compliance costs, make it more difficult to attract and retain qualified officers and members of our board of directors, particularly to serve on our audit committee, and make some activities more difficult, time-consuming, and costly. In addition, if we fail to implement the required controls with respect to our internal accounting and audit functions, our ability to report our results of operations on a timely and accurate basis could be impaired. If we do not implement such required controls in a timely manner or with adequate compliance, we might be subject to sanctions or investigation by regulatory authorities, such as the SEC or the NASDAQ Stock Market. Any such action could harm our reputation and the confidence of investors and clients in our company and could negatively affect our business and cause the price of our common stock to decline.

Provisions of Delaware law, of our amended and restated charter and amended and restated bylaws and our Shareholder Rights Plan may make a takeover more difficult, which could cause our stock price to decline.

Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and in the Delaware corporate law may make it difficult and expensive for a third party to pursue a tender offer, change in control or takeover attempt, which is opposed by management and the board of directors. Public stockholders who might desire to participate in such a transaction may not have an opportunity to do so. In            , 2013, our board of directors adopted a Shareholder Rights Plan that could make it more difficult for a third party to acquire, or could discourage a third party from acquiring, our company or a large block of our common stock. A third party that acquires 20% or more of our common stock could suffer substantial dilution of its ownership interest under the terms of the Shareholder Rights Plan through the issuance of common stock to all stockholders other than the acquiring person. We also have a staggered board of directors that makes it difficult for stockholders to change the composition of the board of directors in any one year. After the planned distribution by Harvard Bioscience, any removal of directors will require a super-majority vote of the holders of at least 75% of the outstanding shares entitled to be cast on the election of directors which may discourage a third party from making a tender offer or otherwise attempting to obtain control of us. These anti-takeover provisions could substantially impede the ability of public stockholders to change our management and board of directors. Such provisions may also limit the price that investors might be willing to pay for shares of our common stock in the future.

Any issuance of preferred stock in the future may dilute the rights of our common stockholders.

Our board of directors has the authority to issue up to      shares of preferred stock and to determine the price, privileges and other terms of these shares. Our board of directors may exercise this authority without any further approval of stockholders. The rights of the holders of common stock may be adversely affected by the rights of future holders of preferred stock.

We do not intend to pay cash dividends on our common stock.

Currently, we do not anticipate paying any cash dividends to holders of our common stock. As a result, capital appreciation, if any, of our common stock will be a stockholder’s sole source of gain.

The recently enacted JOBS Act will allow us to postpone the date by which we must comply with certain laws and regulations and to reduce the amount of information provided in reports filed with the SEC. We cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

We are and we will remain an “emerging growth company” until the earliest to occur of (i) the last day of the fiscal year during which our total annual revenues equal or exceed $1 billion (subject to adjustment for inflation), (ii) the last day of the fiscal year following the fifth anniversary of this offering, (iii) the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt, or (iv) the date on which we are deemed a “large accelerated filer” under the Securities and Exchange Act of

26


 
 

TABLE OF CONTENTS

1934, as amended, or the Exchange Act. For so long as we remain an “emerging growth company” as defined in the JOBS Act, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our common stock less attractive because we will rely on some or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. If we avail ourselves of certain exemptions from various reporting requirements, our reduced disclosure may make it more difficult for investors and securities analysts to evaluate us and may result in less investor confidence.

27


 
 

TABLE OF CONTENTS

MARKET DATA

Unless otherwise indicated, statements in this prospectus concerning our market and the segments in which we operate, including our general expectations and competitive position, business opportunity, and category size, growth, and share, are based on information from independent industry organizations and other third-party sources (including industry publications, surveys, and forecasts), government publications, data from our internal research, and management estimates. Management estimates are derived from the information and data referred to above, and are based on assumptions and calculations made by us based upon our interpretation of such information and data, and our knowledge of our industry and the categories in which we operate, which we believe to be reasonable. We have not independently verified any third-party information, and our internal data have not been verified by any independent source. Furthermore, the information and data referred to above are imprecise. Projections, assumptions, expectations, and estimates regarding our industry and the categories in which we operate and our future performance are also necessarily subject to risk.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus, including the sections entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” contains forward-looking statements within the meaning of the federal securities laws. These statements relate to anticipated future events, future results of operations or future financial performance. These forward-looking statements include, but are not limited to, statements relating to our ability to raise sufficient capital to finance our planned operations, market acceptance of our technology and product offerings, our ability to attract and retain key personnel, our ability to protect our intellectual property, and estimates of our cash expenditures for the next 12 to 24 months. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “intends,” “expects,” “plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other comparable terminology.

These forward-looking statements are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause our (or our industry’s) actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements. The “Risk Factors” section of this prospectus sets forth detailed risks, uncertainties and cautionary statements regarding our business and these forward-looking statements.

We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this prospectus. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the U.S., we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

28


 
 

TABLE OF CONTENTS

OUR SEPARATION FROM HARVARD BIOSCIENCE

Our Relationship with Harvard Bioscience

Harvard Apparatus Regenerative Technology, Inc. was incorporated in May 2012. We are currently a wholly- owned subsidiary of Harvard Bioscience. Harvard Bioscience will not sell any of its shares of our common stock as part of this offering. We will issue new, incremental shares of common stock in this offering. After the completion of this offering, Harvard Bioscience will own at least 80% of our outstanding common stock. At that point, Harvard Bioscience, as majority owner, will still control our company.

We were incorporated by Harvard Bioscience to provide a means for separating its regenerative medicine device business from Harvard Bioscience’s life science research tools businesses. Harvard Bioscience has been designing and manufacturing devices for life science researchers for over 100 years. Harvard Bioscience first focused on providing devices to scientists involved in regenerative medicine research in 2008. Since early 2009, Harvard Bioscience’s regenerative medicine device business initiative operated as a part of Harvard Bioscience. Most of our products began as products made and sold by the Harvard Apparatus division of Harvard Bioscience. Harvard Apparatus began at Harvard Medical School in 1901 and is one of the best known and most respected brand names in physiology research. We believe this expertise and reputation are major advantages in attracting leading physicians as collaborators and will ultimately be valuable in selling our products to hospitals and clinicians. We will continue to pursue our business of developing and making devices for regenerative medicine researchers and clinicians.

Prior to this offering, Harvard Bioscience will have contributed to us the assets of its regenerative medicine device business and cash in an amount equal to approximately $10 million. We had no material assets or activities as a separate corporate entity until the contribution to us by Harvard Bioscience of the businesses described in this prospectus.

For several reasons enumerated in “Benefits of Separation” below, Harvard Bioscience decided to separate its regenerative medicine device business into a separate corporate entity, authorize such entity to sell equity to raise capital and then spin-off its interest in our company to the Harvard Bioscience stockholders. Prior to the completion of this offering, we will enter into agreements with Harvard Bioscience that will govern the separation of our businesses from Harvard Bioscience and various interim and ongoing relationships. These agreements will be in effect as of the completion of this offering. These agreements will provide for, among other things, the transfer from Harvard Bioscience to us of assets and the assumption by us of liabilities comprising our businesses, employee and tax-related matters, intellectual property cross licenses, product distribution agreements, non-competition agreements and the transitional services Harvard Bioscience will provide to us. All of the agreements relating to our separation from Harvard Bioscience will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of our separation from Harvard Bioscience. See “Certain Relationships and Related Transactions — Agreements with Harvard Bioscience” for a more detailed discussion of these agreements. For more information regarding the assets and liabilities to be transferred to us, see financial statements and accompanying notes included elsewhere in this prospectus. The terms of these agreements may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See “Risk Factors — Risks Related To Separation — We may have received better terms from unaffiliated third parties than the terms we received in our agreements with Harvard Bioscience.”

We intend to establish two wholly owned foreign subsidiaries, one in Germany and the other in Sweden that, in accordance with certain transition agreements between us and Harvard Bioscience, will be provided with services from certain subsidiaries of Harvard Bioscience.

29


 
 

TABLE OF CONTENTS

Benefits of Separation

We believe that the business benefits that will occur as a result of this offering, and be more fully realized upon a later spin-off, include:

Market recognition of the value of our business .  As we will be a separate public company after this offering, potential investors will be able to invest directly in our regenerative medicine business.
Focused management attention .  Our management will be better able to focus its attention on our business. As a company dedicated to the regenerative medicine industry, capitalizing on emerging trends, and introducing new products and product extensions of our existing products, we expect to be in a better position to grow our business and to serve our customers more effectively through more efficient deployment of resources, increased operational flexibility, and enhanced responsiveness to customers.
Improved access to capital .  As a separate public company, we will avoid conflicts in the allocation of capital between us and other Harvard Bioscience businesses. Rather, we will have direct access to the capital markets to issue equity or debt securities, which we expect will improve our access to capital and increase our flexibility to invest in innovation, product development, marketing, and production capacity, as well as to pursue strategic acquisitions.
Incentives for employees more directly linked to our performance .  We expect to enhance employee motivation and to strengthen our management’s focus on our business through incentive compensation programs specifically tied to the results of our business operations and the market performance of our common stock. We believe that these incentives will enhance our ability to attract and retain qualified personnel.

Distribution by Harvard Bioscience of Our Shares

Harvard Bioscience plans to distribute all of the shares of our common stock it owns to Harvard Bioscience’s stockholders on or shortly after the date that is four months after the completion of this offering by means of a spin-off, which is a pro rata distribution by Harvard Bioscience of the shares of our common stock it owns to holders of Harvard Bioscience’s common stock. Harvard Bioscience’s agreement to complete the distribution is contingent on the satisfaction or waiver of a variety of conditions, including the receipt by Harvard Bioscience of a private letter ruling from the IRS substantially to the effect that, among other things, the distribution, together with certain related transactions, will qualify as a transaction that is generally tax-free for U.S. federal income tax purposes under Sections 355 and 368(a)(1)(D) of Internal Revenue Code, or the Code. In addition, Harvard Bioscience has the right to terminate its obligations to complete the distribution if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the distribution is not in the best interests of Harvard Bioscience or its stockholders. As a result, the distribution may not occur by the contemplated time or at all. Following the distribution, Harvard Bioscience will no longer own any of our outstanding common stock and we will thus be a separate corporate entity.

Registrar and Transfer Company, which currently serves as the transfer agent and registrar for Harvard Bioscience’s common stock, will serve as transfer agent and registrar for our common stock and as distribution agent in connection with the distribution.

Dilution Related to the Distribution by Harvard Bioscience of Our Shares

At the time of Harvard Bioscience’s distribution of our common stock it then owns, holders of Harvard Bioscience stock options and restricted stock units issued previously to employees and directors as part of Harvard Bioscience’s equity compensation plans, including our executive officers and certain of our directors, will receive an adjustment to their stock options and restricted stock units because those securities will not participate in the distribution. Such adjustment is required under Harvard Bioscience’s employee benefit plans. The adjustments will be based on the estimated value of the entire distribution, as measured by the relationship between Harvard Bioscience’s common stock price just prior to and after the distribution. We expect that Harvard Bioscience’s common stock price will decrease due to Harvard Bioscience’s distribution of our shares, which would cause an adjustment to the quantity of outstanding Harvard Bioscience stock options and restricted stock units and to the exercise price of outstanding Harvard Bioscience options. It is

30


 
 

TABLE OF CONTENTS

currently anticipated that Black-Scholes valuation modeling will be used to determine the value that each Harvard Bioscience option has lost at the time of the distribution. We expect that, for adjustments to the quantity of outstanding stock options and restricted stock units, Harvard Bioscience will provide 80% of the value of the adjustment by issuing the holder additional Harvard Bioscience restricted stock units and options for shares of Harvard Bioscience common stock and 20% of the value of the adjustment will be provided by us issuing restricted stock units and options for shares of our common stock. The share amounts and exercise prices of the adjusted Harvard Bioscience awards and our awards would be adjusted in a manner to ensure the intrinsic value held by the holder pertaining to the existing Harvard Bioscience award is maintained immediately following the distribution and shall be determined in a manner designed to result in no tax being triggered under Section 409A of the Internal Revenue Code. The exercise price of our common stock options to be issued as part of the distribution adjustment described above will equal the closing price of our common stock on the grant date.

The total value of the adjustments to be granted to holders of Harvard Bioscience options and restricted stock units due to Harvard Bioscience’s distribution of its shares of our common stock will depend on Harvard Bioscience’s common stock price just prior to and after the distribution. Many factors may influence Harvard Bioscience’s common stock price just before and after the distribution, including, but not limited, to the value of our company reflected in Harvard Bioscience’s common stock price just prior to the distribution, the liquidity and trading volumes in Harvard Bioscience’s common stock, conditions in Harvard Bioscience’s other businesses, general economic conditions, events outside of Harvard Bioscience’s business that may affect Harvard Bioscience’s stock price and activities in stock markets at large. The total value of the adjustments will also depend on other estimates, including those involved in valuing options. As a result, the number of options for our common stock and the quantity of our restricted stock units to be issued at the time of the distribution is not known at this time. Subject to the above qualifications, assuming that the market price of Harvard Bioscience’s common stock was $     per share immediately prior to the distribution and $     per share immediately after the distribution, and the market price of our common stock was $     per share immediately after the distribution, we expect that we would issue approximately       options to acquire shares of our common stock and approximately       restricted stock units as a part of the required adjustment to the outstanding Harvard Bioscience stock options and restricted stock units described above.

Our stock options and restricted stock units issued at the distribution to holders of Harvard Bioscience stock options and restricted stock units issued previously to employees and directors as part of Harvard Bioscience’s equity compensation plans will vest in tandem with the originally-issued stock options and restricted stock units for the remaining life of the originally-issued stock options and restricted stock units. The continued vesting and exercisability of the stock options and restricted stock units will be conditioned on the recipient’s continued service to or employment with Harvard Bioscience or our company.

Separately, certain of our employees and directors, including our executive officers, are holders of vested and unvested options to buy Harvard Bioscience common stock and unvested restricted stock units pertaining to Harvard Bioscience’s common stock. Vesting and exercisability of such options and restricted stock units will continue through their original expiration dates so long as the individual holder is employed or providing service to us or Harvard Bioscience.

With respect to individual owners of both options and/or restricted stock units issued by our company and those issued by Harvard Bioscience, the compensation expense for such options and restricted stock units will be recognized by the company receiving the individual’s services. However, cash proceeds from the future option exercises will be realized by the company that issued the respective option.

31


 
 

TABLE OF CONTENTS

USE OF PROCEEDS

The net proceeds from the sale of common stock by us in this offering will be approximately $     million, based on the initial public offering price of $     per share (which is the midpoint of the price range set forth on the cover page of this prospectus), and after deducting underwriting discounts and commissions. A $1.00 increase (decrease) in the assumed initial public price per share of     , the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately     , assuming the number of shares offered by us, set forth on the cover page of this prospectus, remains the same after deducting underwriting discounts and estimated offering price by us. If the underwriters exercise in full their option to purchase additional shares, we expect to receive approximately $     million of additional net proceeds. In addition, Harvard Bioscience has agreed to contribute cash to us upon the closing of this offering in an amount equal to approximately $10 million.

The principal purposes of this offering are to obtain additional capital and to create a public market for our common stock. We expect to use the net proceeds of this offering for general corporate purposes, including spending for research and development, business development, sales and marketing, capital expenditures and working capital.

Pending such uses, we plan to invest the net proceeds from this offering in bank deposit accounts, short-term, interest-bearing obligations, certificates of deposit or direct or guaranteed obligations of the U.S. government.

DETERMINATION OF OFFERING PRICE

Prior to this offering, there has been no public market for our common stock. The initial public offering price will be negotiated among us and the underwriters. Among the factors to be considered in determining the initial public offering price of our common stock, in addition to prevailing market conditions, will be our historical performance, estimates of our business potential and earnings prospects, an assessment of our management and the consideration of the above factors in relation to market valuation of companies in related businesses. We offer no assurances that the initial public offering price will correspond to the price at which our common stock will trade in the public market subsequent to this offering or that an active trading market for our common stock will develop and continue after this offering.

DIVIDEND POLICY

We have never declared or paid cash dividends. We do not intend to pay cash dividends on our common stock for the foreseeable future, but currently intend to retain any future earnings to fund the development and growth of our business. The payment of cash dividends, if any, on the common stock will rest solely within the discretion of our board of directors and will depend, among other things, upon our earnings, capital requirements, financial condition, legal requirements, and other relevant factors as determined by our board of directors. There can be no assurance that we will continue to pay any dividends if we do commence the payment of dividends.

32


 
 

TABLE OF CONTENTS

CAPITALIZATION

The following table sets forth our capitalization as of September 30, 2012:

on an actual basis; and
on a pro forma “as adjusted” basis to reflect the pro forma transactions, which are comprised of:
the receipt of approximately $     million in net proceeds from the sale of shares of our common stock in this offering at an assumed initial offering price of $     per share (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the underwriting discount and estimated offering expenses payable by us; and
the receipt of approximately $10 million in cash from Harvard Bioscience;
assumes the completion of a     for 1 stock split;
excludes       shares of our common stock reserved for issuance under the 2013 Equity Incentive Plan, or 2013 Plan, upon the exercise of stock options, restricted stock units, or restricted stock that will be issued under our employee benefit plans, which will include:
      shares of our common stock reserved for issuance in connection with the initial grants to our executives and employees that will be granted following the determination of the initial public offering price per share of our common stock in this offering, as described in “Director and Executive Compensation — IPO Grants;”
shares of our common stock that may be issued in connection with compensation of our directors, as described in “Director and Executive Compensation — Board of Directors’ Compensation;” and
shares of our common stock that may be issued in connection with the exercise or vesting of options or restricted stock units we issue pertaining to the adjustment and conversion of outstanding Harvard Bioscience equity awards upon the effectiveness of the spin-off, as described in “Director and Executive Compensation — Treatment of Outstanding Harvard Bioscience Equity Awards;” and
assumes the underwriters will not exercise their over-allotment option.

You should read the information in the following table together with “Use of Proceeds,” “Selected Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our audited and unaudited financial statements and the related notes included elsewhere in this prospectus.

   
  As of September 30, 2012
     Historical   Pro forma as adjusted
     (Unaudited)
(in thousands)
Long-term debt   $     $  
Total invested equity   $ 140     $  
Stockholders’ equity:
                 
Preferred stock, $0.01 par value; no shares authorized; no shares issued and outstanding               
Common stock, $0.01 par value;       shares authorized;       shares issued and outstanding as adjusted               
Additional paid-in capital               
Total stockholders’ equity                   
Total capitalization   $ 140     $         

33


 
 

TABLE OF CONTENTS

Assuming the receipt of approximately $10 million in cash from Harvard Bioscience and no change in the number of shares offered by us as set forth on the cover page of this prospectus, a $1.00 increase (decrease) in the assumed initial public offering price of $     per share (which is the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) each of cash and cash equivalents, additional paid-in capital, and total stockholders’ equity by $    , and would increase (decrease) total capitalization by $    , after deducting the underwriting discount and estimated offering expenses payable by us.

34


 
 

TABLE OF CONTENTS

DILUTION

Dilution represents the difference between the initial offering price and the net tangible book value per share immediately after completion of this offering. Net tangible book value is the amount that results from subtracting total liabilities and intangible assets from total assets. Dilution of the value of the shares you purchase is a result of the lower book value of the shares held by our existing stockholder, Harvard Bioscience.

At            , 2012, the net tangible book value of our shares of common stock was $     or approximately $     per share based upon       shares outstanding. After giving effect to our sale of       shares of common stock at an initial public offering price of $     per share (which is the midpoint of the price range set forth on the cover page of this prospectus), and after deducting underwriting discounts and commissions and estimated offering expenses, our pro forma net tangible book value as of            , 2012 would have been $    , or $     per share. This represents an immediate increase in net tangible book value of $     per share to our existing stockholder, Harvard Bioscience, and an immediate dilution in net tangible book value of $     per share to purchasers of securities in this offering, as illustrated in the following table:

   
Assumed initial public offering price per share            $  
Pro forma net tangible book value per share
as of            , 2012
  $                  
Increase per share attributable to new investors                   
Pro forma as adjusted net tangible book value per share
after this offering
                  
Dilution per share to new investors in this offering         $         

If the underwriters exercise their option to purchase additional shares in full, the pro forma as adjusted net tangible book value per share after giving effect to the offering would be $    per share. This represents an increase in pro forma as adjusted net tangible book value of $    per share to existing stockholders and dilution in pro forma as adjusted net tangible book value of $    per share to new investors.

A $1.00 increase (decrease) in the assumed initial public offering price of $    , the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as adjusted net tangible book value after this offering by $    million and the pro forma as adjusted net tangible book value per share after this offering by $    per share and would increase (decrease) the dilution per share to new investors in this offering by $    per share, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. The information discussed above is illustrative only and may change based on the actual initial public offering price and other terms of this offering determined at pricing.

The above discussion does not include the shares of common stock reserved for future issuance under our equity incentive plans and:

assumes the completion of a          for 1 stock split;
excludes       shares of our common stock reserved for issuance under the 2013 Equity Incentive Plan, or 2013 Plan, upon the exercise of stock options, restricted stock units, or restricted stock that will be issued under our employee benefit plans, which will include:
     shares of our common stock reserved for issuance in connection with the initial grants to our executives and employees that will be granted following the determination of the initial public offering price per share of our common stock in this offering, as described in “Director and Executive Compensation — IPO Grants;”
shares of our common stock that may be issued in connection with compensation of our directors, as described in “Director and Executive Compensation — Board of Directors’ Compensation;” and

35


 
 

TABLE OF CONTENTS

shares of our common stock that may be issued in connection with the exercise or vesting of options or restricted stock units we issue pertaining to the adjustment and conversion of outstanding Harvard Bioscience equity awards upon the effectiveness of the spin-off, as described in “Director and Executive Compensation — Treatment of Outstanding Harvard Bioscience Equity Awards;”
assumes the underwriters will not exercise their over-allotment option; and
assumes that the shares of our common stock to be sold in this offering are sold at $      per share, the midpoint of the price range set forth on the cover page of this prospectus.

36


 
 

TABLE OF CONTENTS

SELECTED HISTORICAL FINANCIAL DATA

The following table sets forth our selected financial data for the periods and as of the dates indicated. You should read the following selected financial data in conjunction with our audited and unaudited financial statements and the related notes thereto included elsewhere in this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus.

Our historical results are not necessarily indicative of the results that may be expected in the future and interim results are not necessarily indicative of results to be expected for any other period or the full year.

           
  Period from February 24, 2009 (inception) to December 31, 2009   Years ended   Nine months ended   Period from February 24, 2009 (inception) to September 30, 2012
     December 31,   September 30,
     2010   2011   2011   2012
(in thousands)             (unaudited)   (unaudited)   (unaudited)
Statement of Operations Data:
                                                     
Net Revenue   $     $     $     $     $     $  
Cost of product revenues                                    
Gross Profit                                    
Operating Expenses:
                                                     
Selling and marketing expenses           53       215       68       91       359  
General and administrative expenses     188       572       1,251       753       1,631       3,642  
Research and development expenses     394       727       2,285       1,679       3,025       6,431  
Total operating expenses     582       1,352       3,751       2,500       4,747       10,432  
Operating Loss     (582 )       (1,352 )       (3,751 )       (2,500 )       (4,747 )       (10,432 )  
Loss before income taxes     (582 )       (1,352 )       (3,751 )       (2,500 )       (4,747 )       (10,432 )  
Net loss   $ (582 )     $ (1,352 )     $ (3,751 )     $ (2,500 )     $ (4,747 )     $ (10,432 )  

       
  As of December 31,   As of
September 30,
2012
  2009   2010   2011
(in thousands)               (unaudited)
Balance Sheet Data:
                                   
Total Assets   $     $ 1     $ 187     $ 295  
Total Liabilities     70       269       165       155  
Harvard Bioscience, Inc.
invested equity (deficit)
  $ (70 )     $ (268 )     $ 22     $ 140  

37


 
 

TABLE OF CONTENTS

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

The following management’s discussion and analysis should be read in conjunction with our historical financial statements and the related notes included in this prospectus. The management’s discussion and analysis contains forward-looking statements that involve risks and uncertainties, including those we detail under “Risk Factors,” “Special Note Regarding Forward-Looking Statements” and elsewhere in this prospectus, such as statements of our plans, objectives, expectations and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify certain of these forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements in this prospectus. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. We do not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this prospectus.

Overview

Relationship with Harvard Bioscience

Harvard Apparatus Regenerative Technology, Inc. is a wholly-owned subsidiary of Harvard Bioscience, Inc. We were incorporated on May 3, 2012 by Harvard Bioscience to provide a means for separating its regenerative medicine device business from its other businesses. Harvard Bioscience has been designing and manufacturing devices for life science researchers for over 100 years. Harvard Bioscience first focused on providing devices to scientists involved in regenerative medicine research in 2008. Since early 2009, Harvard Bioscience’s regenerative medicine device business initiative has been operated as a division of Harvard Bioscience. Harvard Bioscience decided to separate its regenerative medicine business into our company, a separate corporate entity, to authorize us to raise capital by selling equity and then to spin off its interest in our business to its stockholders. Prior to this offering, Harvard Bioscience will have contributed the assets of its regenerative medicine device business and approximately $10 million in cash to us. We had no material assets or activities as a separate corporate entity until the contribution to us by Harvard Bioscience of those assets and that business. We will continue to pursue our business of developing and making devices for regenerative medicine researchers and clinicians.

Our Business

We are a clinical-stage regenerative medicine company developing life-saving medical devices. Our first products are a bioreactor and a synthetic scaffold that can be used by surgeons to create a replacement trachea, or airway, for patients who need an airway transplant. Our bioreactor technology has been used in six successful human airway transplant surgeries, including what we believe to be the world’s first transplant of a regenerated airway. In addition, we believe the second surgery using our technology was the world’s first transplant of a regenerated airway using a synthetic scaffold. We use our depth of knowledge, our existing technologies and products and continued research and development to develop and provide devices to be used by physicians for growing organs outside the body for transplant. We are also developing a clinical infusion pump based on Harvard Apparatus’s market-leading research syringe pump technology for use by clinicians.

Business Drivers/Factors Affecting Results of Operations

To date, our business efforts have been focused on developing and providing new bioreactor products to regenerative medicine researchers and practitioners and on developing a clinical infusion pump. We have not generated revenues to date. Going forward, we intend to generate revenues from the sale of our synthetic scaffolds and bioreactors, some of which will be given to certain key researcher collaborators to accelerate development of new bioreactor technologies and some of which will generate revenues. Until we receive regulatory agency approvals to market one or more bioreactor systems for clinical use we expect our costs to exceed our revenues. Over the next few years we also expect to generate revenues from sales of clinical infusion pumps. However, we expect our initial sales will be of research-only infusion pumps, and until we

38


 
 

TABLE OF CONTENTS

receive regulatory agency approval to market infusion pumps for clinical use we expect the addressable market opportunity and sales of infusion pumps will be modest.

Once we receive regulatory agency approvals to market our bioreactor and synthetic scaffold for surgeons to use in human transplant procedures, especially for trachea transplants, we expect to generate meaningful revenues. At that time we anticipate that we will be paid on a per-procedure basis for the use of our bioreactor and scaffold products. Although we hope to receive regulatory approvals to market our bioreactors and synthetic scaffolds for use by surgeons to perform transplants of additional organs, we expect that approval for our trachea transplant products alone will lead to sufficient sales for us to achieve profitability. In addition, we may seek approval under the orphan biologics pathway for the use of our scaffold and bioreactor system, including cells, for regenerated trachea transplant, which could provide market exclusivity for up to seven years.

Basis of Presentation

Historically, we have operated as part of Harvard Bioscience, and not as a stand-alone company. Financial statements were not previously prepared for us since we did not operate as a separate legal entity prior to our separation from Harvard Bioscience. The discussion and analysis of our financial condition and results of operations are based on the historical Harvard Bioscience regenerative medicine device business, which we prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements required that we make estimates and assumptions that affect the reported amounts of assets and liabilities at the dates of the financial statements and the expenses during the reporting periods presented. Assets and liabilities have been presented at Harvard Bioscience’s book values for those items at the dates of the financial statements. Certain of the expenses were allocated based on estimates of costs incurred by Harvard Bioscience on behalf of the regenerative medicine business or services provided by Harvard Bioscience personnel who were not wholly engaged in the regenerative medicine device business but who supported that business directly or indirectly during the reporting periods. Actual results may differ from these estimates under different assumptions or conditions.

Related Party Relationship with Harvard Bioscience

Harvard Bioscience will not sell any of its shares of our common stock as part of this offering. We will issue new, incremental shares of common stock in this offering. After the completion of this offering, Harvard Bioscience will own a majority of our outstanding common stock and, as majority owner, will still control us.

Harvard Bioscience plans to distribute all of the shares of our common stock it then owns to Harvard Bioscience’s stockholders on or after the date that is four months after the completion of this offering by means of a spin-off, which is a pro rata distribution by Harvard Bioscience of the shares of our common stock it owns to holders of Harvard Bioscience’s common stock. Harvard Bioscience’s agreement to complete the distribution is contingent on the satisfaction or waiver of a variety of conditions. In addition, Harvard Bioscience has the right to terminate its obligations to complete the distribution if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the distribution is not in the best interests of Harvard Bioscience or its stockholders. As a result, the distribution may not occur by the contemplated time or at all.

Prior to the completion of this offering, we will enter into agreements with Harvard Bioscience that will govern the separation of our businesses from Harvard Bioscience and various interim and ongoing relationships. These agreements will be in effect as of the completion of this offering. They will provide for, among other things, the transfer from Harvard Bioscience to us of assets and the assumption by us of liabilities comprising our businesses. In accordance with such agreements, we expect to pay Harvard Bioscience to provide continued services in the areas of accounting, payroll, benefits administration, information services and technology, engineering and marketing communications for periods ranging from six months to one year. All of the agreements relating to our separation from Harvard Bioscience will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of our separation from Harvard Bioscience. The terms of these agreements may be more or less favorable to us than if they had been negotiated with unaffiliated third parties.

39


 
 

TABLE OF CONTENTS

Results of Operations

Components of Operating Loss

Research and development expense .  Research and development expense consists primarily of salaries and related expenses for personnel and contracted consultants to develop our new products. Other research and development expenses include the costs of outside service providers and material costs for prototype and test units. We expense research and development costs as incurred.

General and administrative expense .  General and administrative expense consists primarily of salaries and other related costs for personnel in executive, accounting, information technology and human resources roles. Other costs include professional fees for legal and accounting services, insurance, investor relations and facility costs.

Sales and marketing expense .  Sales and marketing expense consists primarily of salaries and related expenses for personnel performing sales, marketing, and business development roles, and costs associated with their travel and participation in trade shows and conferences. It also includes the costs of catalogs, marketing communications and web site development and maintenance.

Comparison of Nine Months Ended September 30, 2012 and 2011

Research and Development Expense

Research and development expense increased $1.3 million, or 80%, to $3.0 million for the nine months ended September 30, 2012 compared with $1.7 million for the nine months ended September 30, 2011. Of the $1.3 million increase, approximately $0.9 million related to a substantial increase in our activities in organ bioreactor research and development and $0.4 million represented increased efforts in the clinical infusion pump. The increased bioreactor development costs in 2012 included additional engineering and technical resources. These increases were made to support a greater number of regenerative medicine collaborators and to accelerate the development of several new bioreactors to help further their research efforts. The increased activities related to organ bioreactor also included the costs related to three trachea transplant procedures, compared with one such procedure in the nine months ended September 30, 2011.

General and Administrative Expense

General and administrative expense increased $0.9 million, or 117%, to $1.6 million for the nine months ended September 30, 2012 compared with $0.8 million for the nine months ended September 30, 2011. Of the $0.9 million increase, $0.2 million was due to greater legal fees associated with the organization and operation of the business. Approximately $0.4 million of the year-to-year increase related to increased management focus from Harvard Bioscience’s senior executives which increased our allocated expense. Payroll-related costs for such individuals were allocated to our business based on the percentage of their time spent managing or supporting our business. Also, we established a quality assurance and regulatory compliance function during 2011 which accounted for approximately $0.1 million of the year-to-year general and administrative expense increase, audit costs increased by $0.1 million and various other costs increased by a combined $0.1 million year-to-year.

Sales and Marketing Expense

Sales and marketing expense increased approximately $23,000, or 32%, to $91,000 for the nine months ended September 30, 2012 compared with $68,000 for the nine months ended September 30, 2011. The increase was primarily due to greater market development costs related to our bioreactor products.

Comparison of the Years Ended December 31, 2011 and 2010

Research and Development Expense

Research and development expense increased $1.6 million, or 214%, to $2.3 million for the year ended December 31, 2011 compared with $0.7 million for the year ended December 31, 2010. Of the $1.6 million increase, approximately $1.2 million related to a substantial increase in resources devoted to our development of a clinical infusion pump product and $0.4 million reflected increased efforts in our organ bioreactor development program, including the costs related to our support of two human trachea transplants during

40


 
 

TABLE OF CONTENTS

2011. Approximately $1.1 million of the year-to-year cost increase in the clinical infusion pump project represented additional engineering headcount and consulting costs related to design and engineering services. The increased bioreactor-related research and development costs in 2011 included the effects of three of our scientists devoting a much greater percentage of their time to the regenerative medicine device business in that year compared with the prior year, and the payroll-related costs of one scientist hired during 2011.

General and Administrative Expense

General and administrative expense increased approximately $0.7 million, or 119%, to $1.3 million for the year ended December 31, 2011 compared with $0.6 million for the year ended December 31, 2010. Of the $0.7 million increase, approximately $0.3 million of the year-to-year increase related to increased management focus from Harvard Bioscience’s senior executives which increased our allocated expense. Payroll-related costs for such individuals were allocated to our business based on the percentage of their time spent managing or supporting our business. Of the $0.7 million year-to-year increase in general and administrative expense, $0.2 million represented other Harvard Bioscience costs allocated to our business and $0.1 million represented an increase in professional fees.

Sales and Marketing Expense

Sales and marketing expense increased approximately $0.2 million, or 303%, to $0.2 million for the year ended December 31, 2011 compared with $53,000 for the year ended December 31, 2010. The increase was primarily due to the costs to publish a catalog, brochures and marketing literature, greater tradeshow participation and web site content development.

Comparison of the Year Ended December 31, 2010 and the Period from February 24, 2009 (Inception) to December 31, 2009

Research and Development Expense

Research and development expense increased $0.3 million, or 85%, to $0.7 million for the year ended December 31, 2010 compared with $0.4 million for the period ended December 31, 2009. The increase was primarily due to greater payroll-related costs and consulting fees incurred for our clinical infusion pump development project in 2010.

General and Administrative Expense

General and administrative expense increased approximately $0.4 million, or 202%, to $0.6 million for the year ended December 31, 2010 compared with $0.2 million for the period ended December 31, 2009. The increase was primarily related to increased management focus from Harvard Bioscience’s senior executives, which increased our allocated expense. Payroll-related costs for such individuals were allocated to our business based on the percentage of their time spent managing or supporting our business.

Sales and Marketing Expense

Sales and marketing expense was approximately $0.1 million for the year ended December 31, 2010. No sales and marketing expense was incurred during the period ended December 31, 2009. The 2010 sales and marketing expenses were primarily payroll-related costs allocated to our business by Harvard Bioscience for employees who supported our market development efforts that year.

Financial Condition, Liquidity and Capital Resources

Sources of liquidity .  We have incurred operating losses and negative operating cash flow since inception, and we had an accumulated deficit of $10.4 million as of September 30, 2012. Since inception, our operations have been funded by contributions from Harvard Bioscience. We are currently investing significant resources in the development and commercialization of our products for use by clinicians and researchers in the field of regenerative medicine. As a result, we expect to incur operating losses and negative operating cash flow for the foreseeable future.

We will raise approximately $     million from the issuance and sale of shares of our common stock in this offering. In addition, concurrent with the completion of this offering, Harvard Bioscience will contribute approximately $10 million in cash to us.

41


 
 

TABLE OF CONTENTS

Operating activities .  Net cash used in operating activities of $4.4 million for the nine months ended September 30, 2012 was primarily a result of our $4.7 million net loss, offset by the add-back of non-cash expenses of $0.3 million of stock-based compensation and $38,000 of depreciation. Net cash used in operating activities of $2.3 million for the nine months ended September 30, 2011 was primarily a result of our $2.5 million net loss, offset by the add-back of non-cash expenses of $0.2 million of stock-based compensation.

Net cash used in operating activities of $3.6 million for the year ended December 31, 2011 was primarily a result of our $3.8 million net loss and a $0.1 million unfavorable effect from the change in working capital, partially offset by a $0.3 million add-back of non-cash expenses.

Net cash used in operating activities of $1.0 million for the year ended December 31, 2010 was primarily a result of our $1.4 million net loss, partially offset by a $0.1 million add-back of non-cash stock-based compensation expense and a $0.2 million favorable effect from the change in working capital.

Net cash used in operating activities of $0.5 million for the period from February 24, 2009 (inception) to December 31, 2009 was a result of our $0.6 million net loss, partially offset by a $0.1 million favorable effect from the change in working capital.

Investing activities .  Net cash used in investing activities during the nine month periods ended September 30, 2012 and 2011 and the year ended December 31, 2011 reflected additions to property, plant and equipment.

Financing activities .  Cash generated from financing activities in all periods presented represented Harvard Bioscience’s funding of our business activities.

Tax Attributes Relating to Historical Operating Losses

All tax attributes, including net operating losses and tax credits, related to our operating losses through the date of our separation from Harvard Bioscience will remain with Harvard Bioscience following the separation.

Option Vesting, Compensation Expense and Exercise Proceeds

In connection with the planned distribution of our common stock by Harvard Bioscience, we expect to issue options to purchase our common stock and restricted stock units to Harvard Bioscience employees and directors who hold options and restricted stock units issued by Harvard Bioscience prior to the distribution. Such stock options and restricted stock units that we issue at the distribution will vest in tandem with the stock options and restricted stock units originally-issued by Harvard Bioscience for the remaining life of such stock options and restricted stock units. The continued vesting and exercisability of the stock options and restricted stock units we issue will be conditional on the recipient’s continued service to or employment with Harvard Bioscience or our company.

Separately, certain of our employees and directors, including our executive officers, are holders of vested and unvested options to buy Harvard Bioscience common stock and unvested restricted stock units pertaining to Harvard Bioscience’s common stock. Vesting and exercisability of such options and restricted stock units will continue through their original expiration dates so long as the individual holder is employed or providing service to us or Harvard Bioscience.

With respect to individual owners of both options and/or restricted stock units issued by our company and those issued by Harvard Bioscience, the compensation expense for such options and restricted stock units will be recognized by the company receiving the individual’s services. However, cash proceeds from the future option exercises will be realized by the company that issued the respective option.

Future Funding Requirements

We have generated operating losses each year to date. We do not expect to generate sufficient revenues to achieve annual earnings or positive cash flows until we obtain regulatory approval and commercialize one of our organ bioreactors and synthetic scaffolds. Until that time, we expect to maintain or increase our ongoing development activities. Also, upon the closing of this offering, we expect to incur additional costs associated with operating as a publicly-traded company.

42


 
 

TABLE OF CONTENTS

Harvard Bioscience will no longer fund our operations following the closing of this offering. Based on our current operating plan, we believe that the net proceeds from this offering and the approximately $10 million cash contribution from Harvard Bioscience will be sufficient to fund our operating expenses, working capital needs and capital expenditures for at least the next 24 months following the completion of this offering. We have based our estimates on assumptions that may prove wrong, and we may use our available capital resources sooner than we expect. Further, our strategy or business plan may change in the future, possibly changing the rate of our spending or need for additional capital. We may need to secure future funding through equity offerings, debt financings, government funding, marketing and distribution arrangements and other collaborations or strategic alliances. Equity offerings would dilute the ownership interests of existing stockholders. Debt financing, if available, could result in agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures or paying dividends. If we raise additional funds through government funding, marketing and distribution arrangements or other collaborations or strategic alliances we may have to relinquish rights to our technologies or future revenue streams, or grant licenses on terms that may not be favorable to us. We cannot assure you that we will be successful in raising additional capital on favorable terms or at all. In addition, to preserve the tax-free treatment to Harvard Bioscience of the distribution, for the two-year period following the distribution we will be limited in issuing equity securities beyond certain thresholds which will may limit our ability to raise additional capital.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements, including unrecorded derivative instruments that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Effect of Inflation and Changes in Prices

We do not expect inflation and changes in price to have a material effect on our operations in the next year.

Recent Authoritative Accounting Guidance

Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

Critical Accounting Policies and Estimates

Our financial statements, which appear at page F-1, have been prepared in accordance with accounting principles generally accepted in the U.S., which require that we make certain assumptions and estimates and, in connection therewith, adopt certain accounting policies. Our significant accounting policies are set forth in Note 2 to our financial statements included in this prospectus. Of those policies, we believe that the policies discussed below may involve a higher degree of judgment and may be more critical to an accurate reflection of our financial condition and results of operations.

Stock-Based Compensation

We account for stock-based payment awards in accordance with the provisions of FASB ASC 718, Compensation — Stock Compensation , which requires us to recognize compensation expense for all stock-based payment awards, including stock options and restricted stock units, made to employees and directors. All amounts shown in the financial statements presented in this prospectus related to stock-based compensation pertain to Harvard Bioscience employees who were participants in the Harvard Bioscience stock option plans and/or the Harvard Bioscience Employee Stock Purchase Plan and were directly involved in the regenerative medicine device business and were allocated based upon each participant’s time spent on our business.

43


 
 

TABLE OF CONTENTS

We value stock-based payment awards, except restricted stock awards, at grant date using the Black-Scholes option-pricing model. Our determination of fair value of stock-based payment awards has been affected by the Harvard Bioscience common stock price as well as assumptions regarding a number of complex and subjective variables, such as expected stock price volatility and employee forfeitures over the terms of the awards.

Stock-based compensation expense recognized under FASB ASC 718 for the years ended December 31, 2011, 2010 and 2009 was $0.3 million, $0.1 million and $31,000, respectively, which consisted of stock-based compensation expense related to employee stock options, the Harvard Bioscience Employee Stock Purchase Plan and restricted stock units. We record stock compensation expense on a straight-line basis over the requisite service period for all awards granted.

Also, we expect to grant to certain of our executives, employees and our directors, upon determination of the initial offering price, grants of options for shares of our common stock in order to, among other things, provide executives, employees and directors with a stock-based incentive and align their interests with those of our stockholders. The value of the stock option grants will be expensed ratably over a four-year vesting term. We expect some of these grants to be performance-based options which will be earned upon achievement of certain milestones.

44


 
 

TABLE OF CONTENTS

BUSINESS

We are a clinical-stage regenerative medicine company developing life-saving medical devices.

Our first products are a bioreactor and a synthetic scaffold that can be used by surgeons to create a replacement trachea, or airway, for patients who need an airway transplant. We believe our products are the first to enable the application of regenerative medicine techniques to the production and transplant of complex, three-dimensional human organs like the trachea. Our bioreactor technology has been used in six successful human airway transplant surgeries, including what we believe to be the world’s first transplant of a regenerated airway. In addition, we believe the second surgery using our technology was the world’s first transplant of a regenerated airway using a synthetic scaffold. The patients who received these two airway transplants are alive more than four years and 20 months, respectively, following their surgeries, and each of these surgeries were published in The Lancet , one of the world’s most respected peer-reviewed medical journals. The six human airway transplants to date have been led by Dr. Paolo Macchiarini, a world-renowned thoracic surgeon of the Karolinska Instituet, one of Europe’s leading research hospitals.

We believe our technology could enable surgeons to cure nearly all primary trachea cancers. Our products addresses the critical challenges to trachea transplant: the shortage of suitable donor tracheas and the risk and expense of lifelong anti-rejection drug therapy. Because the scaffolds are synthetic, our technology will eliminate the need to wait for suitable donor tracheas. Our technology also obviates the need for anti-rejection drug therapy because the surgeon uses the patient’s own bone marrow cells to seed the scaffold. In addition, patients with trachea cancer treated using our products have not required either chemotherapy or radiation therapy after the transplant, thus potentially eliminating the significant side effects and expense of such therapies. Because these substantial costs and risks can be reduced or even eliminated with our technology, we believe our products can both help save lives and reduce overall healthcare costs. None of the surgeries using our products have involved human embryonic stem cells and we do not currently expect surgeons to use such cells with our products.

In addition to the trachea, we believe that our products are applicable to the regeneration of other organs. Our collaborators are working on regenerating the lungs, gastrointestinal tract, heart valves and heart using our products. For instance, a collaborator of ours, Dr. Harald Ott of Massachusetts General Hospital, has succeeded in using one of our solid organ bioreactors to regenerate and transplant a whole lung in a rat. In addition to Dr. Ott, we are collaborating with several other research groups in the U.S. and Europe on lung regeneration. Two collaborators of ours, one at a major U.S. pediatric hospital and one at a major European teaching hospital, have used our bioreactors in research on the regeneration of an esophagus. Another collaborator of ours, Dr. Robert Simari of the Mayo Clinic, has used one of our bioreactors in his research on the regeneration and transplant of human heart valves. In addition to Dr. Simari’s work on heart valve regeneration, we are collaborating with three additional research groups in the U.S. and in Europe on heart regeneration.

The first six airway transplant surgeries took place in Spain, Sweden and Russia under compassionate-use regulations on patients who had exhausted alternative treatment options. One of our collaborators, Dr. Mark Holterman, Professor of Surgery and Pediatrics at the Children’s Hospital of Illinois in Peoria, has received FDA approval under an investigator-led IND application allowing the first use of our products in a trachea transplant in the U.S.

We intend to seek separate, independent 510(k) clearances or exemptions in the U.S., and CE marking in the EU, to allow us to market our trachea scaffolds, bioreactors and clinical infusion pumps for medical device uses, where such pathways are appropriate and as discussed in greater detail below. In addition, we may seek approval under the orphan biologics pathway for the use of our scaffold and bioreactor system, including cells, for regenerated trachea transplant, which could provide market exclusivity for up to seven years. We believe that this orphan drug pathway may be feasible for our trachea transplant products based the severity of the disease being treated, the number of patients impacted with conditions that can be treated using the seeded trachea scaffold product, and the lack of approved treatment methodologies for these patients. Based on initial review of FDA and EU regulatory precedent, and our understanding of the status of ongoing clinical investigation of the trachea scaffold products, we expect to receive regulatory approval to market our regenerated trachea transplant products in the EU by the end of 2015 and, assuming our trachea transplant products qualify for accelerated review, we expect to receive FDA approval to market our trachea transplant products in the U.S. by the end of 2016.

45


 
 

TABLE OF CONTENTS

Industry Overview

The first human organ transplant was a kidney transplant performed in 1954. The donor of the kidney was the identical twin of the recipient and therefore there was no immune rejection of the organ. The recipient lived for eight years following the transplant and the surgeon who performed the transplant, Dr. Joseph Murray, went on to win the Nobel Prize for this work. The recipient of the first heart transplant, performed in 1967 by Dr. Christiaan Barnard, lived only 18 days. The patient did not die because the new heart failed, but because of pneumonia that the patient acquired due to the patient’s immune system being compromised by the anti-rejection drugs that the patient had to take. These two cases illustrate both the promise and the challenges of organ transplantation: donor organs can greatly extend life, but there is a critical shortage of donors and, unless the donor is the identical twin of the recipient, the recipient’s body will always reject the donor organ. In order to combat this rejection, the patient must take lifelong anti-rejection drugs which compromise the immune system and greatly increase the risk of the patient dying from infections.

In the 1960s, anti-rejection drugs were very poor and hence very few organ transplants took place. In the 1970s, better anti-rejection drugs, particularly cyclosporine, were developed and by the late 1970s many heart transplant patients were living up to five years with their donor hearts. In 1983, the FDA approved cyclosporine for use in organ transplantation, and the first lung transplant patient survived more than six years. Although the improved anti-rejection drugs increased the life expectancy for patients receiving organ transplants, they came with harmful side effects that shortened the recipient’s natural life span. In addition to the side effects, the anti-rejection drugs are also very expensive and can cost $20,000 to $30,000 per year and must be taken for as long as the patient lives. Despite the side effects and costs, organ transplants have become common enough that the shortage of donors is now the key constraint to organ transplants. To increase the number of organ transplants the U.S. government made a huge effort to increase organ donation. This included Congress passing seven separate pieces of legislation, Medicare paying for donor transplants, several Surgeons General making personal appeals for more organ donors and the U.S. Department of Health and Human Services making the Emmy award-winning documentary No Greater Love on the benefits of organ donation. Despite all these efforts, waiting lists for organ transplants continued to grow and by 2011 there were over 100,000 Americans waiting for a donor organ.

In the late 1980s, the field of regenerative medicine emerged as scientists began to apply principles of engineering and life sciences to develop techniques that could restore, maintain or improve body function. Regenerative medicine now includes products that use cells to repair damaged organs and to grow organs outside the body for transplant into the patient. Early successes in regenerative medicine included the skin grafting products Apligraf and Dermagraft, which were approved by the FDA in 1998 and 2001, respectively. Apligraf has since been used to treat over 200,000 patients. However, the regeneration of more complex three-dimensional structures like the trachea proved much harder than two-dimensional structures like the skin. Additional progress came with using regenerated tissue grafts to increase urinary bladder capacity and with regenerating blood vessels for grafting between veins and arteries.

In 2008, a milestone was reached when the two fields of organ transplant and regenerative medicine were combined with the world’s first transplant of a regenerated airway. Even though the airway scaffold came from a donor, because the patient’s own bone marrow cells were used to seed the scaffold after the cells from the donor had been removed, the patient did not require anti-rejection drugs. Other than the transplant of organs between genetically identical twins, such as the first kidney described above, we believe this regenerated airway transplant was the world’s first organ transplant that has not required anti-rejection drugs. In 2011, another milestone was reached with the world’s first transplant of a regenerated airway using a synthetic scaffold. This patient has also not needed to take anti-rejection drugs, and because the scaffold was made in a laboratory, the patient did not have to wait for a donor organ to become available. This breakthrough opens the possibility that the waiting lists for organ transplants can be reduced or even eliminated.

Overview of the Trachea Transplant Market

Trachea cancer is a devastating and almost always fatal disease. Current treatments such as radiation therapy, chemotherapy and surgery have poor outcomes, resulting in median survival of only 10 months and a five-year survival rate of only 15%. According to an article published in The Lancet Oncology , the incidence of trachea cancer is 2.6 per one million of population, reflecting an addressable market of approximately 2,400

46


 
 

TABLE OF CONTENTS

trachea cancer patients per year worldwide. In addition to trachea cancer, certain types of trachea damage can be treated by transplanting a trachea. In particular, patients may receive a tracheotomy, or surgically created hole in their throat, to allow them to breathe. When the tracheotomies are in place for more than a few days, patients are at increased risk of dying from pneumonia caused by aspiration of foreign material into the lungs. We estimate that there are approximately 3,900 trachea damage patients per year worldwide. In addition, there are approximately 250 patients in the developed world who are born without a trachea, a condition called tracheal agenesis, who may be treatable with a trachea transplant.

Combining patients with trachea cancer, trachea trauma and tracheal agenesis, we estimate the total addressable patient population for trachea transplants using our products is approximately 6,500 per year. While we cannot predict what the total potential market will be when and if we obtain regulatory approval to market our trachea products, based solely on there being at least 6,500 patients per year at the time of such approval, we estimate the total potential market for trachea transplants that use our products could exceed $300 million per year if we were able to charge at least $50,000 per procedure for our trachea products. While these estimates capture the number of new patients annually that are candidates for transplants using our products, they exclude what we believe to be a much larger pool of existing potential patients.

Patients with trachea cancer typically are treated with radiation therapy, chemotherapy or a combination of both. There are a number of common significant side effects of radiation therapy and chemotherapy, including pain, fatigue, hair loss and kidney and bladder problems. Such therapies are also expensive, with chemotherapy alone typically costing $24,000 per patient annually.

While surgery is a preferred treatment option for trachea cancer, it is rarely performed because most trachea cancers are not diagnosed until it is too late for surgery to be a viable option. A trachea transplant has also not been a viable option to date due to the difficulties of finding an anatomical match between the donor and the patient. Even if a donor trachea were available, the patient would require anti-rejection drugs for the remainder of his or her life to prevent rejection of the donor trachea. This therapy is expensive, typically costing $20,000 to $30,000 per patient annually. There is also a risk to the patient as anti-rejection drugs suppress the immune system causing even a mild infection to become potentially life threatening.

Previous attempts to implant a tracheal prosthetic have been unsuccessful as they have been unable to create a functional lining of the trachea which is essential to the clearance of mucus. Without the clearance of mucus, patients have poor prognosis and typically die from pneumonia or respiratory failure shortly after transplant.

Patients that contract aspiration pneumonia caused by tracheotomies are treated with antibiotics that often fail, leading to the death of the patient. Trachea transplant is almost never used to treat these patients today due to the lack of suitable donor tracheas.

Nearly all patients that are born without a trachea die within a few minutes of birth due to lack of oxygen. On rare occasions a hole forms between the patient’s esophagus and lungs that can allow a surgeon to insert a breathing tube to connect the lungs with the mouth. However, we know of no patient born with tracheal agenesis who has survived more than six years.

Our Solution

We believe the use of the medical device products we are currently developing, together with the patient’s own cells, will provide a system for surgeons that is a major advance over the current therapeutic options for treating trachea cancer and trachea trauma and may be applicable to other medical conditions requiring organ transplants. We believe our products are the first to enable the application of regenerative medicine techniques to the production and transplant of complex, three-dimensional organs like the trachea. With continued development, we believe that our technologies will be applicable to the repair or transplant of other important human organs such as the lungs, gastrointestinal tract, heart valves, and heart. Our bioreactor technology was used in both the world’s first transplant of a regenerated airway in 2008 and in the world’s first transplant of a synthetic regenerated airway in 2011.

We believe our products will overcome the major challenges in trachea and other organ transplantation. Unlike traditional organ transplants, our products will eliminate the need for a donor because the scaffold will be manufactured in a factory. In addition, for hollow organs, such as the trachea, our technology enables the production of a transplant that precisely matches the patient’s anatomy. Because the surgeon uses the patient’s

47


 
 

TABLE OF CONTENTS

own bone marrow cells to seed the scaffold, our technology also eliminates the risk and expense of lifelong anti-rejection drug therapy. In addition, patients with trachea cancer treated using our products have not required either chemotherapy or radiation therapy after the transplant, thus eliminating the significant side effects and expense of such therapies. Because these substantial costs can be reduced or even eliminated with our technology, we believe our products can both help save lives and reduce overall healthcare costs.

Further, human embryonic stem cells have not been used in any of the procedures involving our trachea transplant products. This eliminates both the medical risks and ethical controversy associated with regenerative medicine approaches using human embryonic stem cells and other controversial sources of cells.

We believe the use of our products together with the patient’s own bone marrow cells solves both the major challenges facing organ transplant: a synthetic scaffold avoids the need to wait for a donor and the use of the patient’s own cells avoids the risk and costs of anti-rejection drug therapy. The first application of our products is in treating trachea cancer but we believe the technology can be developed to apply to other important human organ transplants as well.

While these regenerative medicine technologies are being studied clinically and refined, our products will have defined uses that should allow their independent marketing as medical devices, subject to regulatory clearance, approval, and marketing authorization.

Our Strategy

Our objective is to be the leading regenerative medicine device company focused on helping save human lives. Our business strategy to accomplish this objective includes:

Target life-threatening medical conditions.   We are focused on creating products to help surgeons treat serious conditions like trachea cancer, and diseases requiring GI tract, heart or lung transplant. We are not targeting relatively low-severity conditions that have reasonable alternative treatment options like damage to the skin, bones, muscles, ears or nose. By targeting life-threatening conditions, we believe it is easier to get patient informed consent for treatment, hospital ethics committee or Institutional Review Board approval and government regulatory authority approval as the patients often have poor or no treatment alternatives. We believe it will also be easier for our customers to get reimbursement for treatments for life-threatening conditions that have poor and/or more expensive alternative treatments. To further the development of these technologies, while also generating revenues, we are developing and intend to market components of the regenerative medicine applications that have medical device uses for such independent uses.

Focus on medical devices rather than cells.   Medical devices generally have easier and lower cost clinical trial requirements than cellular-based therapies, provided that the FDA agrees that the scaffold, clinical infusion pump, and bioreactor products we are developing are separate medical devices, and not part of an overall biological seeded scaffold. We do not intend to sell cells or tissue. Our business model is to sell medical devices that could be used by a surgeon for a range of clinical applications and protocols. We leave the choice of cell type, cell seeding conditions and surgical approach up to the surgeon. It is possible that in some applications the surgeon may use no cells at all on the scaffold. In this sense our scaffold products are more like stents or prosthetic devices than cells or tissue.

Develop products that have a relatively short time to market.   Since the number of patients with trachea cancer is relatively small, we expect the number of patients that we would likely need to enroll in a clinical trial would be relatively small. A small number of patients implies a relatively fast and inexpensive clinical trial. In addition, since survival is likely to be a key endpoint in any trachea transplant trial and median survival in trachea cancer is only 10 months we expect we would be able to conduct a clinical trial in a relatively short period of time compared to clinical trials in indications with higher survival rates and longer survival periods. We intend to work closely with regulatory agencies and clinical experts to design and size the clinical studies appropriately based on the specific conditions our products are intended to treat.

Use trachea transplant as a platform to address other organs.   We believe our experience in developing proprietary scaffolds and bioreactors for trachea transplant gives us substantial expertise and intellectual property for developing products addressing diseases impacting other organs like the lungs, gastrointestinal tract, heart valves, and heart. We intend to use such expertise and intellectual property to develop medical devices to help treat other serious medical conditions requiring organ transplants.

48


 
 

TABLE OF CONTENTS

Supply the complete bioreactor and scaffold system.   Our technology includes the bioreactor and scaffold which are used by the surgeon to create the synthetic organ. We believe there is considerable value in supplying the complete bioreactor and scaffold system.

Collaborate with leading surgeons and institutions.   We have and will continue to collaborate with leading surgeons and institutions. For example, we have collaborated with Professor Macchiarini of the Karolinska Instituet to improve our bioreactors and to create our scaffolds for use in trachea transplant; we have collaborated with Dr. Harald Ott of Massachusetts General Hospital to develop our lung bioreactor system, and we have collaborated with Dr. Robert Simari of the Mayo Clinic to develop our heart valve bioreactor. It is these collaborators who have developed the cell seeding and surgical techniques for use with our products. We believe the use of our products by leading surgeons and institutions will increase the likelihood that other surgeons and institutions will use our products.

Our Products

[GRAPHIC MISSING]

Bioreactors

Hollow Organ Bioreactor

[GRAPHIC MISSING]

   InBreath hollow organ bioreactor in use during the Krasnodar surgeries, June 2012.

Equipment and materials used as general cell culture equipment and instruments, including bioreactors, are regulated as Class I medical devices pursuant to 21 C.F.R. § 864.2240. These devices are exempt from FDA’s premarket notification or approval requirements, and may be marketed for general research uses consistent with in vitro culture of cells.

49


 
 

TABLE OF CONTENTS

Our InBreath hollow organ bioreactor is a device that can be used by a surgeon to seed cells onto a scaffold. The InBreath bioreactor enables the surgeon to:

secure the scaffold to the bioreactor;
seed the patient’s cells on the scaffold under sterile conditions;
automatically rotate the scaffold to allow good cell distribution into the pores of the scaffold; and
remotely monitor the scaffold during the course of the two to three days of incubation before the transplant.

The InBreath bioreactor has several novel features such as allowing for separate cell seeding conditions on the inside and outside of the scaffold and for pumping cell culture media through the inside of the scaffold without the need for an external pump and tubes. We have rights to an issued patent and pending patent applications directed to various features of the bioreactors. We believe the InBreath bioreactor is the world’s first bioreactor that has been used to perform a human transplant of a regenerated organ.

The cell seeding and incubation are performed by the surgeons or other hospital staff at the hospital according to their own procedures which can vary from patient to patient and hospital to hospital. Our employees are not involved in obtaining the cells, seeding the cells or performing the transplant.

We expect that bioreactors to be used in regenerating sections of the GI tract and other hollow organs will likely share much of the technology of the InBreath bioreactor.

Solid Organ Bioreactor

[GRAPHIC MISSING]

   Automated Solid Organ Bioreactor

A solid organ bioreactor shares many of the features of a hollow organ bioreactor such as the ability to seed cells on an organ scaffold and keep them sterile and healthy during the growth phase prior to transplant. However, for solid organs like the heart and lungs, the bioreactor must also supply pulsatile blood flow and ventilation to mimic the natural action of the heart and lungs. In addition, the physiology of the heart and lung is considerably more complex than that of the trachea and so the measuring, monitoring and control equipment needed is considerably more advanced. During the first half of 2010, one of our physician collaborators, Dr. Harald Ott at Massachusetts General Hospital, succeeded in regenerating a lung that was subsequently transplanted into the body of a rat showing near normal lung function. In collaboration with Dr. Ott and Massachusetts General Hospital, we designed and developed a novel bioreactor that was used to grow the rat lung used in this procedure. The work was published in Nature Medicine in July 2010.

We have collaborated with Dr. Ott since 2008 and continue to develop organ bioreactor technologies for his use. The current generation bioreactor, pictured above, is considerably more advanced as it is capable of controlled decellularization and recellularization of an organ, including an organ as large as a human lung. We

50


 
 

TABLE OF CONTENTS

intend to continue developing bioreactors in collaboration with Dr. Ott and other leading researchers with the goal of eventually using our products to perform a first-in-human transplant of a regenerated lung.

In addition to our human lung bioreactor we also make a similar system for the human heart. This system was also developed in collaboration with Dr. Ott and others. We are also collaborating with leading clinical researchers to develop bioreactors for esophagus, heart valve, liver and kidney regeneration. The heart valve bioreactor is still in development. It is being developed in conjunction with Dr. Robert Simari at the Mayo Clinic. The other collaborations are currently confidential, but are all with physicians at well-respected academic medical centers. None of these technologies has yet to be extensively tested in animals.

Scaffolds (Trachea Prostheses)

[GRAPHIC MISSING]

   A scaffold (trachea prosthesis) we manufactured

A tracheal prosthesis is defined by the FDA as “a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that are intended to be implanted to restore the structure and/or function of the trachea or tracheal bronchial tree” (21 C.F.R. 878.3720). These products are commercially marketed in the U.S. as Class II medical devices for which Section 510(k) premarket notification is required.

A scaffold is a natural or synthetic framework, shaped like the real organ, that is porous to allow cells to penetrate the scaffold, attach and start to grow. The scaffold used for the first regenerated trachea transplant in 2008 was a donated human trachea with its cells removed using a chemical solution before being seeded with bone marrow cells taken from the recipient. All subsequent trachea transplants using our products have utilized synthetic scaffolds. Because the synthetic scaffolds are manufactured, they can be made to the exact dimensions of the patient and in large quantities. The scaffold dimensions are determined using CT scans interpreted by the surgeon. The synthetic scaffolds used in surgeries to date have been made by third parties, including NFS as well as Dr. Alex Seifalian and other scientists at University College London. The scaffold used in the first surgery using a synthetic scaffold was made in collaboration with University college London and Dr. Macchiarini. The NFS scaffolds were made in collaboration with our Company and Dr. Macchiarini. In order to improve the scaffolds we are collaborating with Professor Macchiarini and others to develop our own scaffold product and manufacturing. We have recently established scaffold manufacturing in our Holliston, Massachusetts facility. Our scaffolds can be made from a variety of plastic polymers such as polyethelyne terephthalate, or PET, which is the same polymer used in the well-known brand of implantable materials known by the trade name Dacron. PET has a long history of safe use in long-term human implants. We have manufactured over 100 prototype scaffolds and we intend to provide our proprietary scaffolds to surgeons for use in future transplants. We believe that our scaffolds will be superior in quality compared to those used in prior surgeries.

51


 
 

TABLE OF CONTENTS

Clinical Infusion Pump

[GRAPHIC MISSING]

   Prototype of our clinical infusion pump

Clinical infusion pumps intended to deliver small volumes of fluids to patients also are medical devices in the U.S. pursuant to 21 C.F.R. 880.5725. These products are commercially marketed in the U.S. as Class II medical devices for which section 510(k) premarket notification is required.

We are developing a clinical infusion pump that can be used by clinicians as a cell injection system. This product will allow clinicians to inject cells directly into damaged tissue. In addition to the cell injection applications, we expect our clinical pump will be used for infusing drugs in general hospital applications. This clinical pump is based on the technology underlying Harvard Bioscience’s market leading Harvard Apparatus research syringe pumps.

A typical cell injection is of 50 microliters total volume spread over several individual injections of 5 – 10 microliters each. Because current clinical infusion pumps do not have the accuracy to deliver these tiny volumes, surgeons typically do not use an automated injection system but rather attempt to inject the cells manually. Injecting manually is inferior to using a clinical infusion pump system as it is hard to achieve consistent injections and hence hard to establish a robust clinical protocol. While injecting manually is acceptable in small scale clinical trials, it is a drawback when trying to establish a robust clinical protocol that could be used on large numbers of patients by many different physicians. To address this need in cell injection, we have developed a clinical infusion pump that can deliver these tiny quantities accurately and reproducibly. In addition, our clinical infusion pump can operate a pre-programmed injection protocol by footswitch control which allows the surgeon to focus exclusively on the placement of the needle in the tissue and to not get distracted by trying to do the injection slowly or by looking at the graduations on the syringe to see how much has been injected.

Many companies have been formed to exploit the potential of cell therapy. We believe there are over 30 cell therapy companies or products that are in human clinical trials for either cardiovascular or neurological applications. Almost all these cell therapies for cardiovascular or neurological applications require the cells to be injected into the tissue of the heart or the spine. We are not developing cell therapies ourselves but are developing clinical infusion pump technology that can be used with all cell types and for many purposes in addition to cell therapy. We expect to receive regulatory approval to market our cell therapy infusion system in the EU by the end of 2013 and in the U.S. by the end 2014. While we cannot predict what the total potential market will be when and if we obtain regulatory approval to market our cell therapy infusion system, we believe the opportunity for our cell therapy infusion system may ultimately be in excess of $20 million per year.

We believe our pump can also address segments within the current clinical syringe pump market where the most common application is infusing drugs into the patient’s bloodstream.

52


 
 

TABLE OF CONTENTS

Clinical Experience

World’s First Human Transplant of a Regenerated Airway

In 2008, our InBreath airway bioreactor technology was used to perform the world’s first human transplant of a regenerated airway. The surgery was conducted by Dr. Macchiarini and his team of surgeons in Barcelona, Spain. The patient had suffered a collapse of her airway following a severe tuberculosis infection. To create the regenerated airway, a donor trachea was obtained and stripped of its cells, and then the patient’s own bone marrow cells were used to seed the donor trachea and prepare it for implantation. Following such regeneration, the regenerated airway was then implanted into the patient. The patient is alive and breathing normally more than four years after the transplant surgery. In addition to improving her breathing, because the cells used in the transplant were her own cells taken from her own bone marrow, she has not had to take anti-rejection drugs after the surgery. This surgery was published in The Lancet in November 2008.

World’s First Successful Transplantation of a Synthetic Tissue Engineered Trachea

In June 2011, our InBreath bioreactor was used for the world’s first successful transplantation of a synthetic tissue engineered trachea. For the first time in history, a patient was given a new trachea made from a synthetic scaffold seeded with his own cells and grown in our bioreactor. The operation was performed in 2011 at the Karolinska University Hospital in Stockholm, Sweden by Dr. Paolo Macchiarini and his team of surgeons. The patient had been suffering from late-stage trachea cancer, which before the surgery would have been inoperable. He was given only a few weeks to live and as such the transplant surgery using our product was a last-resort measure to save the patient’s life. The patient required a tracheo-bronchial scaffold transplant, whereby the scaffold mimics the branched shape of the airway. To create the new synthetic trachea, Dr. Alex Seifalian and other scientists at University College London developed a plastic scaffold shaped like the patient’s natural airway and Dr. Macchiarini seeded it with the patient’s own bone marrow cells. This seeding process prepared the synthetic trachea for implantation and thereafter the regenerated synthetic trachea was implanted into the patient. Because the cells used to regenerate the trachea were the patient’s own, there has been no rejection of the transplant, and, like the first patient described above, this patient is not taking anti-rejection drugs. Because of the regenerated trachea transplant, the patient was alive as of February 9, 2013, over 20 months after the surgery. This surgery was published in The Lancet on November 24, 2011.

World’s Second Successful Transplantation of a Synthetic Tissue Engineered Trachea

In November 2011, our InBreath bioreactor was again used by Dr. Macchiarini to create the implant to treat a patient who was suffering from late-stage trachea cancer and required a tracheo-bronchial transplant. The operation was performed at the Karolinska University Hospital by Dr. Macchiarini and his team of surgeons. The procedure was similar to the world’s first successful transplantation of a synthetic tissue engineered trachea done in June 2011, with the exception that the plastic scaffolding material was changed to a fiber construction rather than a porous solid construction. The fibrous scaffold seeded in our bioreactor for this November 2011 procedure was manufactured by NFS and was made in a different laboratory than the one made for the June 2011 patient. The patient recovered well from the transplant surgery and was discharged home from the hospital. Approximately four months after the surgery, the patient passed away from pneumonia secondary to a tracheal tumor. There is no indication that our bioreactor or the third-party scaffold played any role in his death. This patient, like the June 2011 patient, had undergone extensive radiation and chemotherapy treatment prior to the transplant, and his tumor was not responsive to these forms of treatment.

June 2012 Russian Transplants

In June 2012, our InBreath bioreactors were used for the world’s first two successful laryngo-trachea transplants, using synthetic laryngo-trachea scaffolds seeded with cells taken from the patients’ bone marrow. The surgeries took place at the Krasnodar Regional Hospital in Krasnodar, Russia and were performed by Professors Porhanov and Macchiarini and their team. These two surgeries differed from those for the June and November 2011 procedures described above in that the patients in those prior surgeries both had late stage trachea cancer and both required a tracheo-bronchial scaffold. These Russian patients each had trachea trauma caused by automobile accidents. Both of the Russian patients required laryngo-trachea transplants, whereby the scaffold mimics the shape of the windpipe from the larynx to the point where the trachea branches into the two bronchi which lead to the lungs. Both patients had difficulties breathing and talking and had suffered

53


 
 

TABLE OF CONTENTS

repeated infections prior to the surgeries. The scaffolds in these two cases were fibrous scaffolds manufactured by NFS and similar to the one used in the November 2011 surgery, but were made with a different fiber formulation. Since the transplants, both patients have been released from the hospital and were alive as of December 7, 2012. They are both able to breathe and talk normally.

August 2012

In August 2012 a sixth patient received a trachea transplant created using our InBreath bioreactor. The surgery took place at the Karolinksa Hospital and was performed by Dr. Macchiarini and his team of surgeons. The patient was in critical condition and the trachea transplant was performed in an emergency procedure in an attempt to save the patient’s life. While the patient was alive as of December 7, 2012, she had not been released from the hospital as of such date.

Prospective Patient — U.S.

In February 2012, the FDA approved the first U.S. surgery under an IND application made by Dr. Mark Holterman Professor of Surgery and Pediatrics at the Children’s Hospital of Illinois in Peoria. Dr. Macchiarini is expected to collaborate with Dr. Holterman in performing this surgery. The prospective patient for this surgery is a two-year old girl who was born with trachea agenesis (i.e., without a trachea). She currently breathes through a tube in her esophagus that connects to her lungs. In the opinion of Dr. Holterman, the regenerated trachea transplant is the only option for the patient’s long-term survival. No person born with trachea agenesis has ever survived beyond six years. Since this would be the world’s first regenerated transplant in a child so young there are additional risks above those of the adults treated so far because no one has ever made a scaffold or bioreactor for a patient so small or with the need to grow. In addition, the patient is located in Seoul, South Korea which adds considerable logistical and clinical difficulties in preparing for the surgery in the U.S. For these reasons, this surgery has not yet taken place, however we anticipate that it will in the near future.

All these patients have been treated under compassionate-use protocols meaning their prognosis was very poor. Typically, their bodies are very weak as a result of extensive treatments that often include radiation and chemotherapy. We believe that patients that undergo such extensive treatments are inherently susceptible to serious medical complications following the transplants. These transplant surgeries are typically the last-resort measure to save the patient’s life. We expect that some transplant patients are likely to suffer serious complications or death following the transplants due to issues that are not directly related to the use of our products.

Clinical Trials

Overview

For use as stand-alone medical devices (i.e., for uses other than the preparation of regenerative organs or tissues), we believe our bioreactor is exempt from 510(k) clearance to market and our scaffold and clinical infusion pump are eligible for 510(k) clearance to market in the U.S. In the EU, we believe that our bioreactor, scaffold and clinical infusion pump would be CE marked in accordance with Council Directive 93/42/EEC concerning medical devices. The U.S. clearances to market these specific medical devices are not likely to require clinical studies (based on the current exempt status and/or 510(k) clearance of similar products relying solely on laboratory and/or preclinical testing), and CE marking our products in the EU may not necessarily require the conduct of clinical trials (based on CE marking of similar devices without controlled clinical investigations). Clinical data may, however, be required in the EU to demonstrate conformity with applicable requirements. It is our belief that clearances to market these devices are not likely to require clinical trials. As noted elsewhere in this prospectus, however, the company anticipates that the trachea scaffold product will require completion of ongoing clinical evaluation.

However, in order to market our regenerated trachea products widely, we anticipate that we will need to successfully complete clinical trials. The first indication for which we intend to seek approval that we believe will require clinical trials is treating trachea cancer with a regenerated trachea using a synthetic scaffold. Because trachea cancer is a relatively rare disease, it affects only approximately 800 patients per year in the U.S., but is quickly fatal, median survival is only 10 months, we anticipate that our clinical trials will involve

54


 
 

TABLE OF CONTENTS

relatively few patients and will have a relatively short follow up period. This is true whether the products are regulated in either a medical device or biological product pathway. In the U.S., if this pathway is the medical device pathway then we will seek approval under the FDA’s Humanitarian Device Exemption, or HDE, pathway. This pathway can be used if the patient population is less than 4,000 per year. This pathway is advantageous because the efficacy standard for approval is lower than in the normal device approval pathway. There can be no assurance that the FDA would find the device qualifies for HDE status, or if that status were granted that an HDE application would be approved. If, in the U.S., this pathway is instead the biologics pathway, then we will seek approval under the Orphan Drug pathway. The Orphan Drug pathway can be used if the disease or condition for which the regenerated trachea is intended affects fewer than 200,000 people in the U.S. This pathway is advantageous because, although the safety and efficacy standards for orphan drug products are the same as for all biologics, approval under this pathway could grant the company a seven year exclusivity on marketing the product for that indication in the U.S. There is no equivalent in the EU to HDE pathway. As regenerated trachea products are implantable products, if they were classified as medical devices in the EU, we would need to conduct related clinical studies, unless we can justify relying on already-existing clinical data. If, in the EU, the regenerated trachea products are classified as medicinal products, it would be possible to seek orphan medicinal product classification if we can demonstrate that the products are intended to treat a condition affecting no more than five per 10,000 persons in the EU, or that they are intended for treating a serious or debilitating disease and it is unlikely that without incentives marketing the products would generate sufficient return to justify the necessary related investment. If the regenerated trachea products were classified as orphan medicinal products, they could be entitled to market exclusivity for ten years. The trachea product’s marketing authorization as a medicinal product would, however, be the same as for any medicinal product in the EU.

Russian and EU Clinical Trials

The two Russian transplants, both performed in June 2012, began a clinical trial of trachea transplants for patients with either trachea cancer or trachea damage. The Russian clinical trial is funded by a $5 million grant from the Russian government to the Krasnodar Regional Hospital, one of Russia’s leading transplant centers. The EU has also approved a separate $5 million grant with Dr. Macchiarini as the principal investigator to fund two clinical trials in trachea transplant, using our products. We expect the first of these two EU trials to begin in 2014. We intend to use the results of these trials, together with the data collected on the compassionate-use patients both in the U.S. and overseas to help support the applications for approval to market our trachea transplant products in the U.S. and worldwide.

Research and Development

Our primary research and development activities are in engineering and testing electromechanical devices like our bioreactors and infusion pumps and in designing and making scaffolds. As of November 1, 2012, we employed 11 full-time engineers and scientists and we also hire other consultants and part-time employees from time to time.

In addition to our in-house engineering and scientific development team, we collaborate with leaders in the field of regenerative medicine who are performing the fundamental research and surgeries in this field to develop and test new products that will advance and improve the procedures being performed. As these procedures become more common, we will work our collaborators to further enhance our products to make them more efficient and easier to use by surgeons. In addition to Drs. Macchiarini, Holterman, Porhanov and Ott we collaborate with a small number of other leaders in the field of regenerative medicine. Collaboration typically involves us developing new technologies specifically to address issues these researchers and clinicians face. In certain instances, we have entered into agreements that govern the ownership of the technologies developed in connection with these collaborations. These agreements are discussed below in “— Intellectual Property and Related Agreements.” We do not have a collaboration agreement with Dr. Ott. Sometimes we are paid for our products directly, sometimes we are partners on grants and sometimes we give away or loan our technologies to the researchers or clinicians in return for feedback to improve the designs and/or license rights to intellectual property. We are not currently party to any other collaboration agreements with the entities or individuals with whom we collaborate. We are named in the $5 million EU grant for which Dr. Macchiarini is the principal investigator. We have and will continue to work with Dr. Macchiarini with respect to the two clinical trials in trachea transplant using our products funded by such EU grant.

55


 
 

TABLE OF CONTENTS

In addition to our human lung bioreactor we also make a similar system for the human heart. This system was also developed in collaboration with Dr. Ott and others. We are also collaborating with leading clinical researchers to develop bioreactors for esophagus, heart valve, liver and kidney regeneration. The heart valve bioreactor is still in development. It is being developed in conjunction with Dr. Robert Simari at the Mayo Clinic. The other collaborations are currently confidential, but are all with physicians at well-respected academic medical centers. None of these technologies has yet to be extensively tested in animals.

Manufacturing

For our electromechanical devices like our bioreactors and infusion pumps we perform final assembly and test components we buy from third parties like machine shops, parts distributors, molding facilities and printed circuit board manufacturers. These operations are performed primarily at our Holliston, MA headquarters.

For our scaffolds we use a process called electrospinning to create the fabric part of the scaffold. The rings that mimic the natural rings of the trachea are fabricated separately and the fabric and rings are combined. Electrospinning is a well-known fabrication process invented in 1934. It is useful for cell culture applications as it can create extremely thin fibers (much thinner than a human hair) that can make a fabric with pores approximately the same size as a cell. The electrospinning process parameters can be tuned to create a structure that is very reminiscent of the natural structure of the collagen fibers in a decellularized human trachea. Our scaffolds are made from a polymer that does not dissolve in the human body, in other words our scaffolds are intended to be permanent. We believe permanent scaffolds are a better approach than using resorbable materials as it is hard to control the strength of the scaffold as the polymer resorbs.

Sales and Marketing

We expect that most transplants with our trachea transplant products will be performed by a relatively small number of major hospitals in the U.S., EU and other developed countries. As a result we expect to need only a fairly small field sales force. We expect to price the system commensurate with the medical value created for the patient and the high costs avoided with the use of our products. We expect to be paid by the hospital that buys the products from us. We expect that the hospital would seek reimbursement from payors for the entire transplant procedure, including the use of our products.

We intend to use OEMs and distributors to reach the general hospital market for clinical infusion pumps as this is a faster and less investment intensive approach for us to market our clinical infusion pump compared to establishing a field sales force of our own. Since clinical infusion pumps are already a well-established product category there are many existing medical device distributors selling similar products that we expect to be able to work with.

56


 
 

TABLE OF CONTENTS

In addition to the general hospital market for clinical infusion pumps we intend to sell on an OEM basis to companies developing cell therapies. Today there are approximately 30 such companies, though this number is expected to grow. We expect to work with these companies to adapt our clinical infusion pump to their exact injection protocol needs. Sale to the hospital or doctor will be by the OEM not by us directly. As a result we expect to need only a small number of sales and technical support people.

Harvard Bioscience is the exclusive distributor for the research version of our clinical pump and research versions of our clinical products. Harvard Bioscience can only sell the products to the research markets in accordance with the terms of our distribution agreement. We retain all rights to manufacture and sell all our products for clinical use.

Intellectual Property and Related Agreements

We actively seek to protect our products and proprietary information by means of U.S. and foreign patents, trademarks and contractual arrangements. Our success will depend in part on our ability to obtain and enforce patents on our products, processes and technologies to preserve our trade secrets and other proprietary information and to avoid infringing on the patents or proprietary rights of others.

We have rights in the patent and the patent applications listed below. The patent or patents that may issue based on the patent applications are scheduled to expire as provided below:

   
Patent/Technology   Jurisdiction   Expiration
Patent application covering aspects of syringe devices and methods for delivering cells to tissues   Europe, U.S.   2030
Patent application covering aspects of clinical scale bioreactors and tissue engineering   Australia, Europe,
Japan, Russia, U.S.
  2030
Issued Patent covering aspects of liquid distribution in a rotating bioreactor   Germany   2031
Patent application covering aspects of liquid distribution in a rotating bioreactor   PCT — international stage   2032
Patent application covering aspects of synthetic scaffolds and organ and tissue transplantation   PCT — international stage   2032
Patent application covering aspects of synthetic scaffolds and organ and tissue transplantation   U.S.   2032
Patent applications relating to infrared-based methods for evaluating tissue health including methods for evaluating burns   PCT — international stage   2033
Provisional patent applications relating to methods and compositions for producing elastic scaffolds for use in tissue engineering   U.S.   N/A
Provisional patent applications relating to support configurations for tubular tissue scaffolds, and airway scaffold configurations   U.S.   N/A
Provisional patent application relating to methods and compositions for promoting the structural integrity of nanofiber-based scaffolds for tissue engineering   U.S.   N/A
Provisional patent application relating to synthetic airways   U.S.   N/A
Provisional patent application relating to engineered hybrid organs   U.S.   N/A

We also rely on unpatented proprietary technologies in the development and commercialization of our products. We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as those of our advisors, consultants and other contractors. To help protect our proprietary know-how that may not be patentable, and our inventions for which patents may be difficult to enforce, we rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require employees, consultants and advisors to enter into agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and

57


 
 

TABLE OF CONTENTS

inventions that arise from their activities for us. Additionally, these confidentiality agreements require that our employees, consultants and advisors do not bring to us, or use without proper authorization, any third party’s proprietary technology.

Patent Rights Assignment - Dr. Macchiarini

We have entered into a patent rights assignment with Dr. Macchiarini pursuant to which he has assigned to us all of his rights to inventions associated with scaffold design and the clinical protocol used in the world’s first transplant of a synthetic regenerated trachea.

Novel Surgery Agreements

We have entered into novel surgery agreements with each of the State Budget Institution of Public Health Department Regional Clinical Hospital #1 in Krasnodar, Russia, or the Krasnodar Hospital, the employer of Dr. Porhanov, and OSF Healthcare System and Children’s Hospital of Illinois, the employer of Dr. Holterman, pertaining to trachea transplant surgical procedures conducted at such facilities. Such agreements require us to provide our InBreath bioreactors for the procedures and the hospitals to provide all other equipment and services. Such agreements also provide that we will own all inventions arising from the use of our InBreath bioreactor in connection with such procedures, and each hospital has granted us an option to license all inventions independently developed by the hospital in connection with such procedures.

Exclusive License Agreement and Sponsored Research Agreement - InBreath Bioreactor

We have an exclusive license agreement with Sara Mantero and Maria Adelaide Asnaghi to intellectual property rights relating to our InBreath Bioreactor. Under this agreement, we have worldwide rights to intellectual property (including patents, data, and know-how) relating to the hollow organ bioreactor, related techniques, and improvements thereof. We have exclusive worldwide rights to make, use and sell the hollow organ bioreactor, and the right to grant sublicenses and distribution rights. This agreement terminates on the expiration date of the last to expire patent rights that may exist pertaining to inventions of Dr. Mantero or Ms. Asnaghi relating to the hollow organ bioreactor technology or improvements, or August 6, 2016 if on such date no such patent rights exist.

We have entered into a sponsored research agreement with Sara Mantero, Maria Adelaide Asnaghi, and the Department of Bioengineering of the Politecnico Di Milano, or PDM. Under the terms of this agreement, PDM is required to use its facilities and best efforts to conduct a research program relating to the development of bioreactors, clinical applications, and automated seeding processes. We are required to provide engineering support to PDM with respect to bioreactor designs. Intellectual property developed by PDM or its employees, including Dr. Mantero or Ms. Asnaghi, under this sponsored research agreement will be owned by Dr. Mantero or Ms. Asnaghi and covered by our exclusive license agreement described above. In addition, we have an option to an exclusive license for intellectual property relating to new technology that may not be covered by the exclusive license agreement. We will own any inventions and discoveries that we solely develop in connection with the research program and any inventions and discoveries that are jointly developed in connection with the research program will be owned jointly by the parties. The sponsored research agreement will continue until terminated by a party thereto upon 90 days prior written notice.

Sublicense Agreement with Harvard Bioscience

We have entered into a sublicense agreement with Harvard Bioscience pursuant to which Harvard Bioscience has granted us a perpetual, worldwide, royalty-free, exclusive, except as to Harvard Bioscience and its subsidiaries, license to use the mark “Harvard Apparatus” in the name Harvard Apparatus Regenerative Technology. The mark “Harvard Apparatus” is used under a license agreement between Harvard Bioscience and Harvard University, and we have agreed to be bound by such license agreement in accordance with our sublicense agreement. We currently have no affiliation with Harvard University.

58


 
 

TABLE OF CONTENTS

Government Regulation — Medical Device Products

Our products are medical devices subject to extensive regulation by the FDA and other U.S. federal and state regulatory bodies and comparable authorities in other countries. To ensure that medical products distributed domestically and internationally are safe and effective for their intended use, the FDA and comparable authorities in other countries have imposed regulations that govern, among other things, the following activities that we or our partners perform and will continue to perform:

product design and development;
product testing;
product manufacturing;
product labeling;
product storage;
premarket clearance, approval or CE marking of products;
advertising and promotion;
product marketing, sales and distribution; and
post-market surveillance reporting, including reporting of death or serious injuries.

Medical Device Excise Tax

Section 4191 of the Internal Revenue Code, enacted by Section 1405 of the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (124 Stat. 1029 (2010)), in conjunction with the Patient Protection and Affordable Care Act, Public Law 111-148 (124 Stat. 119 (2010)), imposed as of January 1, 2013, an excise tax on the sale of certain medical devices. The excise tax imposed by Section 4191 is 2.3% of the price for which a taxable medical device is sold within the U.S.

The excise tax will apply to future sales of any company medical device listed with the FDA under Section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. Part 807, unless the device falls within an exemption from the tax, such as the exemption governing direct retail sale of devices to consumers or for foreign sales of these devices. We will need to assess to what extent this excise tax may impact the sales price and distribution agreements under which any of our devices are sold in the U.S. We also expect general and administrative expense to increase due to the medical device excise tax. We will need to submit IRS forms applicable to relevant exemptions, make semi-monthly payments of any collected excise taxes, and make timely (quarterly) reports to the IRS regarding the excise tax.

FDA’s Premarket Clearance and Approval Requirements

Unless an exemption applies, each medical device we wish to commercially distribute in the U.S. will require either prior 510(k) clearance or prior premarket approval from the FDA. The FDA classifies medical devices into one of three classes. Devices deemed to pose lower risk are placed in either class I or II, which requires the manufacturer to submit to the FDA a premarket notification requesting permission for commercial distribution. This process is known as 510(k) clearance. Some low risk devices are exempt from this requirement. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in class III, requiring premarket approval. We believe our InBreath bioreactor is a class I medical device, exempt from FDA’s premarket notification or approval requirements, and may be marketed for general research uses consistent with in vitro culture of cells.

A trachea prosthesis is defined by the FDA as a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or tracheal bronchial tree. These products are commercially marketed in the U.S. as class II medical devices for which section 510(k) premarket notification is required. Clinical infusion pumps intended to deliver small volumes of fluids to patients are also class II medical devices for which section 510(k) premarket notification is required. Both premarket clearance and premarket approval, or PMA, applications are subject to the payment of user fees, paid at the time of submission for FDA review.

59


 
 

TABLE OF CONTENTS

510(k) Clearance Pathway

To obtain 510(k) clearance, we must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of premarket approval applications. The FDA’s 510(k) clearance pathway usually takes from three to 12 months, but it can take significantly longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.

After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification, require premarket approval. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), or a premarket approval, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or premarket approval is obtained. If the FDA requires us to seek 510(k) clearance or premarket approval for any modifications to a previously cleared product, we may be required to cease marketing or recall the modified device until we obtain this clearance or approval. Also, in these circumstances, we may be subject to significant regulatory fines or penalties.

Premarket Approval, or PMA, Pathway

A premarket approval application must be submitted if the device cannot be cleared through the 510(k) process. The premarket approval application process is generally more costly and time consuming than the 510(k) process. A premarket approval application must be supported by extensive data including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use.

After a premarket approval application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information. By statute, the FDA has 180 days to review the “accepted application,” although, generally, review of the application can take between one and three years, but it may take significantly longer. During this review period, the FDA may request additional information or clarification of information already provided. Also during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with quality system regulations. New premarket approval applications or premarket approval application supplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device’s indication for use, manufacturing process, labeling and design. Premarket approval supplements often require submission of the same type of information as a premarket approval application, except that the supplement is limited to information needed to support any changes from the device covered by the original premarket approval application, and may not require as extensive clinical data or the convening of an advisory panel. None of our products are currently approved under a premarket approval. In the event that our products are not approved through the 510(k) process, we will be required to seek a PMA.

Clinical Trials

Clinical trials are almost always required to support a premarket approval application and are sometimes required for a 510(k) premarket notification. If the device presents a “significant risk,” as defined by the FDA, to human health, the FDA requires the device sponsor to file an investigational device exemption, or IDE, application with the FDA and obtain IDE approval prior to commencing the human clinical trials. The investigational device exemption application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The investigational device exemption application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a “non-significant risk” device and eligible for more abbreviated investigational device exemption requirements. Clinical trials for a significant risk device may begin once the investigational device exemption application is approved by the FDA and the appropriate institutional review boards at the clinical trial sites. Future clinical trials may require that we

60


 
 

TABLE OF CONTENTS

obtain an investigational device exemption from the FDA prior to commencing clinical trials and that the trial be conducted under the oversight of an institutional review board at the clinical trial site. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA or the investigational review board at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the study. Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device, or may be equivocal or otherwise not be sufficient to obtain approval of our product. Similarly, in Europe the clinical study must be approved by the local ethics committee and in some cases, including studies of high-risk devices, by the Ministry of Health in the applicable country.

Pervasive and Continuing FDA Regulation

After a device is placed on the market, numerous regulatory requirements continue to apply. These include:

product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
Quality System Regulation, or QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;
approval of product modifications that affect the safety or effectiveness of one of our approved devices;
medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;
post-approval restrictions or conditions, including post-approval study commitments;
post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;
the FDA’s recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;
regulations pertaining to voluntary recalls; and
notices of corrections or removals.

We and our third-party manufacturers must register with the FDA as medical device manufacturers and must obtain all necessary state permits or licenses to operate our business. As manufacturers, we and our third-party manufacturers are subject to announced and unannounced inspections by the FDA to determine our compliance with quality system regulation and other regulations. We have not yet been inspected by the FDA.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions
customer notifications for repair, replacement, refunds;
recall, detention or seizure of our products;

61


 
 

TABLE OF CONTENTS

operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
operating restrictions;
withdrawing 510(k) clearances on PMA approvals that have already been granted;
refusal to grant export approval for our products; or
criminal prosecution.

Further, we are subject to various federal and state laws concerning health care fraud and abuse, including false claims laws, anti-kickback laws and physician self-referral laws. Violations of these laws can result in criminal and/or civil punishment, including fines, imprisonment and, in the U.S., exclusion from participation in government health care programs. The scope of these laws and related regulations is expanding and their interpretation is evolving. There is very little precedent related to these laws and regulations. Increased funding for enforcement of these laws and regulations has resulted in greater scrutiny of marketing practices in our industry and resulted in several investigations by various government authorities. If a governmental authority were to determine that we do not comply with these laws and regulations, then we and our officers and employees could be subject to criminal and civil sanctions, including exclusion from participation in federal health care reimbursement programs.

Combination Product/Biologic

Government Regulation Combination Products/Biologics

We believe that some of our products may be defined as combination products consisting of two or more regulated components, a biologic and a medical device. In the U.S., a combination product usually is assigned by the FDA to one of the agency’s centers, such as the CBER or the CDRH with the chosen center to take the lead in pre-marketing review and approval of the combination product. Other FDA centers also may review the product in regard to matters that are within their expertise. The FDA selects the lead center based on an assessment of the combination product’s “primary mode of action.” Some products also may require approval or clearance from more than one FDA center.

To determine which FDA center or centers will review a combination product submission, companies may submit a request for assignment to the FDA. Those requests may be handled formally or informally. In some cases, jurisdiction may be determined informally based on FDA experience with similar products. However, informal jurisdictional determinations are not binding on the FDA. Companies also may submit a formal Request for Designation to the FDA Office of Combination Products. The Office of Combination Products will review the request and make its jurisdictional determination within 60 days of receiving a Request for Designation. We believe that regenerative medicine products containing cells will likely be reviewed by CBER, while the unseeded scaffolds and bioreactor products used to aid in the generation of regenerative medicine products may be reviewed by the CDRH either in consultation with CBER as part of the BLA or separately as a medical device.

Domestic Regulation of Our Products and Business

The testing, manufacturing, and potential labeling, advertising, promotion, distribution, import and marketing of our products are subject to extensive regulation by governmental authorities in the U.S. and in other countries. In the U.S., the FDA, under the Public Health Service Act, the Federal Food, Drug and Cosmetic Act, and its implementing regulations, regulates biologics and medical device products.

The labeling, advertising, promotion, marketing and distribution of biopharmaceuticals, or biologics and medical devices also must be in compliance with the FDA and U.S. Federal Trade Commission, or FTC, requirements which include, among others, standards and regulations for off-label promotion, industry sponsored scientific and educational activities, promotional activities involving the internet, and direct-to-consumer advertising. The FDA and FTC have very broad enforcement authority, and failure to abide by these regulations can result in penalties, including the issuance of a warning letter directing us to correct

62


 
 

TABLE OF CONTENTS

deviations from regulatory standards and enforcement actions that can include seizures, injunctions and criminal prosecution. Recently, promotional activities for FDA-regulated products of other companies have been the subject of enforcement action brought under healthcare reimbursement laws and consumer protection statutes. In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims. In addition, we are required to meet regulatory requirements in countries outside the U.S., which can change rapidly with relatively short notice.

The FDA has broad post-market and regulatory enforcement powers. Manufacturers of biologics and medical devices are subject to unannounced inspections by the FDA to determine compliance with applicable regulations, and these inspections may include the manufacturing facilities of some of our subcontractors. Failure by manufacturers or their suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or other regulatory authorities. Potential FDA enforcement actions include:

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications for repair, replacement, refunds;
recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
operating restrictions;
withdrawing 510(k) clearances on PMA approvals that have already been granted;
refusal to grant export approval for our products; or
criminal prosecution.

In addition, other government authorities influence the success of our business, including the availability of adequate reimbursement from third party payors, including government programs such as Medicare and Medicaid. Medicare and Medicaid reimbursement policies can also influence corresponding policies of private insurers and managed care providers, which can further affect our business.

Biologics Regulation

Biological products must satisfy the requirements of the Public Health Services Act and its implementing regulations. In order for a biologic product to be legally marketed in the U.S., the product must have a BLA approved by the FDA.

The BLA Approval Process

The steps for obtaining FDA approval of a BLA to market a biopharmaceutical, or biologic product in the U.S. include:

completion of preclinical laboratory tests, animal studies and formulation studies under the FDA’s GLP regulations;
submission to the FDA of an IND application, for human clinical testing, which must become effective before human clinical trials may begin and which must include Institutional Review Board, or IRB, approval at each clinical site before the trials may be initiated;
performance of adequate and well-controlled clinical trials in accordance with Good Clinical Practices, or GCP, to establish the safety, purity, and potency of the product for each indication;
submission to the FDA of a BLA, which contains detailed information about the chemistry, manufacturing and controls for the product, reports of the outcomes of the clinical trials, and proposed labeling and packaging for the product;
the FDA’s acceptance of the BLA for filing;

63


 
 

TABLE OF CONTENTS

for any biological product containing an active ingredient not previously approved, automatic referral to an appropriate advisory committee for review prior to approval, unless the FDA decides otherwise;
satisfactory review of the contents of the BLA by the FDA, including the satisfactory resolution of any questions raised during the review or by the advisory committee, if applicable;
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP regulations, to assure that the facilities, methods and controls are adequate to ensure the product’s identity, strength, quality and purity; and
FDA approval of the BLA.

Preclinical studies include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies.

An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct of the trials as outlined in the IND. In that case, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed.

Clinical trials are subject to extensive monitoring, recordkeeping and reporting requirements. Clinical trials must be conducted under the oversight of an IRB for the relevant clinical trial sites and must comply with FDA regulations, including but not limited to those relating to GCP. Adverse events must be reported and investigated timely. To conduct a clinical trial, a company is also required to obtain the patients’ informed consent in form and substance that complies with both FDA requirements and state and federal privacy and human subject protection regulations. The sponsor, the FDA or the IRB could suspend a clinical trial at any time for various reasons, including a belief that the risks to trial subjects outweigh the anticipated benefits. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each site at which the trial is conducted must approve the protocol and any amendments. Foreign studies performed under an IND must meet the same requirements that apply to U.S. studies. The FDA will accept a foreign clinical trial not conducted under an IND only if the trial is well-designed, well-conducted, performed by qualified investigators in accordance with international principles for GCP, and conforms to the ethical principles contained in the Declaration of Helsinki, or with the laws and regulations of the country in which the research was conducted, whichever provides greater protection of the human subjects. The FDA, however, has substantial discretion in deciding whether to accept data from foreign non-IND clinical trials.

Clinical trials involving biopharmaceutical products are typically conducted in three sequential phases. The phases may overlap or be combined. A fourth, or post-approval, phase may include additional clinical trials. These phases are described generally below. We note, however, that the exact number of study subjects required for each specific intended use, and our intent to combine or “telescope” various study phases together, are both areas where we will actively seek FDA feedback to streamline the clinical evaluation process. Briefly, the phases of clinical development generally include the following:

Phase I.  Phase I clinical trials involve the initial introduction of the product into human subjects to determine the adverse effects associated with increasing doses. Such Phase I studies frequently are highly abbreviated or combined with Phase II studies (as outlined below), when the product involves the patient’s own cells.
Phase II.  Phase II clinical trials usually involve studies in a limited patient population to evaluate the efficacy of the product for specific, targeted indications, to determine dosage tolerance and optimal dosage, and to identify possible adverse effects and safety risks. Products that contain the patient’s own cells frequently are studied for initial safety and effectiveness determinations in combined or “telescoped” Phase I/II clinical studies.
Phase III.  If the product is found to be potentially effective and to have an acceptable safety profile in Phase II (or sometimes Phase I) trials, the clinical trial program will be expanded to further demonstrate clinical efficacy, optimal dosage and safety within an expanded patient population at

64


 
 

TABLE OF CONTENTS

geographically dispersed clinical trial sites. As noted, the exact number of subjects needed, the duration of clinical follow-up, and the endpoints by which safety and efficacy are demonstrated are based on the condition being treated.
Post-Approval (Phase IV).  Post-approval clinical trials are required of or agreed to by a sponsor as a condition of, or subsequent to marketing approval. Further, if the FDA becomes aware of new safety information about an approved product, it is authorized to require post approval trials of the biological product. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and to document a clinical benefit in the case of biologics approved under accelerated approval regulations. If the FDA approves a product while a company has ongoing clinical trials that were not necessary for approval, a company may be able to use the data from these clinical trials to meet all or part of any Phase IV clinical trial requirement. These clinical trials are often referred to as Phase III/IV post approval clinical trials. Failure to promptly conduct Phase IV clinical trials could result in withdrawal of approval for products approved under accelerated approval regulations.

Clinical testing may not be completed successfully within any specified time period, if at all. The FDA closely monitors the progress of each of the three phases of clinical trials that are conducted under an IND and may, at its discretion, reevaluate, alter, suspend, or terminate the testing based upon the data accumulated to that point and the FDA’s assessment of the risk/benefit ratio to the patient. The FDA or the sponsor may suspend or terminate clinical trials at any time for various reasons, including a finding that the subjects or patients are being exposed to an unacceptable health risk. The FDA can also request that additional pre-clinical studies or clinical trials be conducted as a condition to product approval. Additionally, new government requirements may be established that could delay or prevent regulatory approval of our products under development. Furthermore, IRBs have the authority to suspend clinical trials in their respective institutions at any time for a variety of reasons, including safety issues.

Certain information about clinical trials, including a description of the trial, participation criteria, location of trial sites, and contact information, is required to be sent to the NIH for inclusion in a publicly-assessable database. Sponsors also are subject to certain state laws imposing requirements to make publicly available certain information on clinical trial results. In addition, the FDA Amendments Act of 2007 directs the FDA to issue regulations that will require sponsors to submit to the NIH the results of certain controlled clinical trials, other than Phase I studies.

Assuming successful completion of the required clinical testing, the results of the preclinical studies and of the clinical trials, together with other detailed information, including information on the chemistry, manufacture and composition of the product, are submitted to the FDA in the form of a BLA requesting approval to market the product for one or more indications. In most cases, the BLA must be accompanied by a substantial user fee. The FDA will initially review the BLA for completeness before it accepts the BLA for filing. There can be no assurance that the submission will be accepted for filing or that the FDA may not issue a refusal-to-file, or RTF. If a RTF is issued, there is opportunity for dialogue between the sponsor and the FDA in an effort to resolve all concerns. If the BLA submission is accepted for filing, the FDA will begin an in-depth review of the BLA to determine, among other things, whether a product is safe and effective for its intended use and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. If the biological product contains a new active ingredient not previously approved, the BLA automatically will be referred to an appropriate advisory committee for review prior to approval of the biological product, unless the FDA decides otherwise and specifies such reasons in a complete response letter to the sponsor. The FDA, however, is not bound by the opinion of the advisory committee.

Companies also may seek fast track designation for their products. Fast track products are those that are intended for the treatment of a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for such a condition. If awarded, the fast track designation applies to the product only for the indication for which the designation was received. Fast track products are eligible for two means of potentially expediting product development and FDA review of BLAs. First, a fast track product may be approved on the basis of either a clinical endpoint or a surrogate endpoint that is reasonably likely to predict

65


 
 

TABLE OF CONTENTS

clinical benefit. Approvals of this kind may be subject to requirements for appropriate post-approval studies to validate the surrogate endpoint or otherwise confirm the effect on the clinical endpoint, and to certain other conditions. Second, if the FDA determines after review of preliminary clinical data submitted by the sponsor that a fast track product may be effective, it may begin review of portions of a BLA before the sponsor submits the complete BLA, thereby accelerating the date on which review of a portion of the BLA can begin. There can be no assurance that any of our other products will receive designation as fast track products. And even if they are designated as fast track products, we cannot assure you that our products will be reviewed or approved more expeditiously for their fast track indications than would otherwise have been the case or will be approved promptly, or at all. Furthermore, the FDA can revoke fast track status at any time.

In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled post-approval clinical trials to verify and further define the product’s clinical benefit and safety profile. There can be no assurance that any of our products will receive accelerated approval. Even if accelerated approval is granted, the FDA may withdraw such approval if the sponsor fails to conduct the required post-approval clinical trials, or if the post-approval clinical trials fail to confirm the early benefits seen during the accelerated approval process.

Fast track designation and accelerated approval should be distinguished from priority review although products awarded fast track status may also be eligible for priority review. Products regulated by the CBER may receive priority review if they provide significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease. Products awarded priority review are given abbreviated review goals by the agency. Under the Prescription Drug User Fee Act of 2007, the agency has agreed to the performance goal of reviewing products awarded priority review within six months, whereas products under standard review receive a ten-month target. The review process, however, is often significantly extended by FDA requests for additional information or clarification regarding information already provided in the submission. Priority review is requested at the time the BLA is submitted, and the FDA makes a decision as part of the agency’s review of the application for filing. We plan to seek priority review for our trachea transplant products but cannot guarantee that the FDA will grant the designation and cannot predict if awarded, what impact, if any, it will have on the review time for approval of our product.

If granted, fast track designation, accelerated approval, and priority review may expedite the approval process, but they do not change the standards for approval.

Before approving a BLA, the FDA will generally inspect the facility or the facilities at which the finished product and its components are manufactured to ensure compliance with cGMP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable, it will either issue “not approvable” letter or an “approvable” letter. A “not approvable” letter means that the FDA refuses to approve the application because the BLA or manufacturing facilities do not satisfy the regulatory criteria for approval. An “approvable” letter means that the FDA considers the BLA and manufacturing facilities to be favorable, but the letter will outline the deficiencies and provide the applicant with an opportunity to submit additional information or data to address the deficiencies. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. Separate approval is required for each proposed indication. If we want to expand the use of an approved product, we will have to design additional clinical trials, submit the trial designs to the FDA for review and complete those trials successfully.

The testing and approval process requires substantial time, effort and financial resources, and each may take several years to complete. Data obtained from clinical activities are not always conclusive, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which

66


 
 

TABLE OF CONTENTS

could delay or preclude us from marketing our products. The FDA may limit the indications for use or place other conditions, such as post approval studies, on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Post-Approval Requirements

After regulatory approval of a product is obtained, companies are required to comply with a number of post-approval requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and recordkeeping. For example, as a condition of approval of a BLA, the FDA may require post-approval testing and surveillance to monitor the product’s safety or efficacy. In addition, holders of an approved BLA are required to keep extensive records, to report certain adverse reactions and production deviations and problems to the FDA, to provide updated safety and efficacy information and to comply with requirements concerning advertising and promotional labeling for their products. If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities, or previously unknown problems with any approved commercial products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions or other setbacks. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

Specifically, our products could be subject to voluntary recall if we or the FDA determine, for any reason, that our products pose a risk of injury or are otherwise defective. Moreover, the FDA can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death. In addition, the FDA could suspend the marketing of or withdraw a previously approved product from the market upon receipt of newly discovered information regarding the product’s safety or effectiveness.

Orphan Drug Designations

The Orphan Drug Act provides incentives to manufacturers to develop and market drugs and biologics for rare diseases and conditions affecting fewer than 200,000 persons in the U.S. at the time of application for orphan drug designation, or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the U.S. for this type of disease or condition will be recovered from sales of the product. Orphan product designation must be requested before submitting a new drug application, or NDA, or BLA. After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. The first developer to receive FDA marketing approval for an orphan biologic is entitled to a seven year exclusive marketing period in the U.S. for that product as well as a waiver of the BLA user fee. The exclusivity prevents FDA approval of another application for the same product for the same indication for a period of seven years, except in limited circumstances where there is a change in formulation in the original product and the second product has been proven to be clinically superior to the first.

Humanitarian Device Exemption

An HDE is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the U.S. per year. HDEs are exempt from requirements to demonstrate effectiveness. Still, they must pose no unreasonable risks, or at least the probable benefits should outweigh the risks. And the device must be used at a facility with an IRB. HDEs provide a powerful incentive for device manufacturers to develop devices that help diagnose or treat patients with rare conditions. Otherwise, a company’s research and development costs would likely exceed the market returns for serving such small patient populations.

67


 
 

TABLE OF CONTENTS

International

We expect to start the regulatory work necessary for the EU submission of our clinical pump in 2013. In addition, we plan to seek required regulatory approvals and comply with extensive regulations governing product safety, quality, manufacturing and reimbursement processes in order to market our products in other major foreign markets. The regulation of our products in the EU and in other foreign markets varies significantly from one jurisdiction to another. The classification of the particular products and related approval or CE marking procedures can involve additional product testing and additional administrative review periods. The time required to obtain these foreign approvals or to CE mark our products may be longer or shorter than that required in the U.S., and requirements for approval may differ from the FDA requirements. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. To date, we have not initiated any discussions with any foreign regulatory authorities with respect to seeking regulatory approval of our products.

In the EU, the Directive 93/42/EEC provides the basic definition of a medical device and lays down the technical and procedural obligations which must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product. Products falling within the scope of the Directive 93/42/EEC are subject to a conformity assessment procedure which often includes the intervention of a notified body. Medical devices must comply with the Essential Requirements laid down in Annex I to the Directive. Directive 93/42/EEC requires that manufacturers maintain a Technical File related to their products and to have clinical data supporting the safety and performance of the products during normal conditions of use. Manufacturers must also comply with quality system requirements which can be met by, among other things, demonstration of compliance with the ISO 13485:2003 standard. If the outcome of the conformity assessment conducted by the notified body is positive, the manufacturer will be issued a related CE Certificate of Conformity by its notified body and will be entitled to affix the CE mark to its medical devices after having signed a related Declaration of Conformity.

The marketing authorization of products containing viable human tissues or cells in the EU is governed by Regulation 1394/2007/EC on advanced therapy medicinal products, read in combination with Directive 2001/83/EC of the European parliament and of the Council, commonly known and the Community code on medicinal products. Regulation 1394/2007/EC lays down specific rules concerning the authorization, supervision and pharmacovigilance of medicinal products, cell therapy medicinal products and tissue engineered products. Manufacturers of advanced therapy medicinal products must demonstrate the quality, safety and efficacy of their products to the European Medicines Agency which is required to provide an opinion regarding the application for marketing authorization. The European Commission grants or refuses marketing authorization in light of the opinion delivered by the European Medicines Agency. Regulation 1394/2007/EC also applies to combination products which consist of medical devices and advanced therapy medicinal products. In light of Regulation 1394/2007/EC, a medical device which forms part of a combined advanced therapy medicinal product must meet the Essential Requirements laid down in Annex I to Directive 93/42/EEC. The manufacturer of the combination product must include evidence of such compliance in its marketing authorization application. The application for a marketing authorization for a combined advanced therapy medicinal product must also, where available, include the results of the assessment of the medical device part by a notified body in accordance with Directive 93/42/EEC.

Legislation similar to the Orphan Drug Act has been enacted in other jurisdictions, including the EU. The orphan legislation in the EU is available for therapies addressing conditions that affect five or fewer out of 10,000 persons. The marketing exclusivity period is for ten years, although that period can be reduced to six years if, at the end of the fifth year, available evidence establishes that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Employees

At December 31, 2012, Harvard Bioscience had     employees working in our business, of whom     are based in the U.S.,     are in Germany and     are in Sweden. Approximately     percent of these employees are principally engaged in research, development, clinical and regulatory activities. None of our employees are unionized. In general, we consider our relations with our employees to be good.

68


 
 

TABLE OF CONTENTS

Properties

Following the separation, we will sublease approximately 10,000 square feet of mixed use space of the facility located at 84 October Hill Road, Holliston, Massachusetts from Harvard Bioscience, which will be our corporate headquarters. Our principal facilities incorporate manufacturing, laboratory, development, sales and marketing, and administration functions. We believe our current facilities are adequate for our needs for the foreseeable future.

Competition

We are not aware of any companies whose products are directly competitive with our bioreactor and scaffold system. However, in our key markets we may in the future compete with multiple pharmaceutical, biotechnology, medical device and scientific research instrument companies, including, among others, Aastrom Biosciences, Aldagen, BioTime, Baxter International, Inc., Bose Corporation, Celgene, Cytori Therapeutics, E. I. du Pont de Nemours and Company, Genzyme (acquired by Sanofi-aventis), Harvest Technologies, Mesoblast, Nanofiber Solutions, Organovo, Osiris Therapeutics, Tengion, Tissue Genesis, Inc., Tissue Growth Technologies, Transmedics, United Therapeutics and W.L. Gore and Associates.

We are not aware of any companies whose products are directly competitive with our clinical infusion pumps for cell injection. However, with respect to our clinical infusion pump for hospital drug infusion applications, we will compete with Baxter International, Inc., Fresenius Medical Care, Smiths Medical, and B. Braun Melsungen, among others.

Many of our potential competitors have substantially greater financial, technological, research and development, marketing, and personnel resources than we do. We cannot forecast if or when these or other companies may develop competitive products.

We expect that other products will compete with products and potential products based on efficacy, safety, cost, and intellectual property positions. While we believe that these will be the primary competitive factors, other factors include, in certain instances, obtaining marketing exclusivity under the Orphan Drug Act, availability of supply, manufacturing, marketing and sales expertise and capability, and reimbursement coverage.

Legal Proceedings

On December 17, 2012, we received correspondence from legal counsel to NFS claiming that in developing our scaffold product and related intellectual property, we may have committed misappropriation, unauthorized use and disclosure of confidential information, and possible infringement of intellectual property rights of NFS. NFS’ legal counsel has also threatened us with legal action, including seeking an injunction, if we are unable to respond in a satisfactory manner to NFS’ claims. We believe that these claims are without merit, and we will vigorously seek to protect our rights regarding such claims. Until we are able to resolve this matter with NFS, we believe it is likely that NFS will continue to pursue this matter against us. Our legal counsel has corresponded with NFS’ counsel since our receipt of the initial letter. While we are still investigating the matter, we do not believe that the matter will have a material adverse effect on our business, financial position or results of operations.

While we are not currently a party to any legal proceedings, from time to time we may be a party to a variety of legal proceedings that arise in the normal course of our business.

69


 
 

TABLE OF CONTENTS

MANAGEMENT
 
Our Directors and Executive Officers Following the Separation

The following table sets forth information as of December 11, 2012, regarding individuals who serve as our directors and/or executive officers.

   
Name   Age   Position(s)
David Green   48   President, Chief Executive Officer
and Chairman of the Board of Directors
Thomas McNaughton   52   Chief Financial Officer
Chane Graziano   74   Director
John F. Kennedy   64   Director
Thomas Robinson   53   Director

David Green — President, Chief Executive Officer, and Chairman

Mr. Green has served as our President, Chief Executive Officer, and Chairman of our board of directors since May 3, 2012. Mr. Green has also been the President and a member of the board of directors of Harvard Bioscience since March 1996. Upon completion of the planned distribution of our common stock by Harvard Bioscience, Mr. Green will no longer be the President of Harvard Bioscience but will remain a director. Mr. Green’s previous experiences include working as a strategy consultant with Monitor Company, a strategy consulting company, in Cambridge, Massachusetts and Johannesburg, South Africa from June 1991 until September 1995 and a brand manager for household products with Unilever PLC, a packaged consumer goods company, in London from September 1985 to February 1989. Mr. Green currently sits on the Advisory Board of the Harvard Business School Healthcare Initiative and on the Executive Advisory Board of The University of Massachusetts Lowell Nanomanufacturing Center. Mr. Green graduated from Oxford University with a B.A. Honors degree in physics and holds a M.B.A. degree with distinction from Harvard Business School.

We believe Mr. Green’s qualifications to sit on our board of directors include his executive leadership experience, his experience founding the regenerative medicine business at Harvard Bioscience, his significant operating and management expertise and the knowledge and understanding of our company that he has acquired over 16 years of service as the President and director of Harvard Bioscience.

During the time period following the consummation of this offering and the planned distribution of our common stock by Harvard Bioscience, Mr. Green will remain employed at both our company and Harvard Bioscience but will devote substantially all his time to our company’s day to day operations.

Thomas McNaughton — Chief Financial Officer

Mr. McNaughton has served as our Chief Financial Officer since May 3, 2012. Mr. McNaughton has also been the Chief Financial Officer of Harvard Bioscience since November 2008. Upon completion of the planned distribution of our common stock by Harvard Bioscience, Mr. McNaughton will no longer be the Chief Financial Officer of Harvard Bioscience. From 2007 to 2008, Mr. McNaughton was a consultant providing services primarily to an angel-investing group and a silicon manufacturing start-up. From 2005 to 2007, Mr. McNaughton served as Vice President of Finance and Chief Financial Officer for Tivoli Audio, LLC, a venture capital-backed global manufacturer of premium audio systems. Prior to joining Tivoli Audio, LLC, from 1990 to 2005, Mr. McNaughton served in various managerial positions in the areas of financial reporting, treasury, investor relations, and acquisitions within Cabot Corporation, a global manufacturer of fine particulate products, and served from 2002 to 2005 as Finance Director, Chief Financial Officer of Cabot Supermetals, a $350 million Cabot division that provides high purity tantalum and niobium products to the electronics and semiconductor industries. Mr. McNaughton practiced from 1982 to 1990 as a Certified Public Accountant in the audit services group of Deloitte & Touche, LLP. Mr. McNaughton holds a B.S. in accounting and finance from Babson College.

During the time period following the consummation of this offering and the planned distribution of our common stock by Harvard Bioscience, Mr. McNaughton will remain employed at both our company and Harvard Bioscience but will split his time between the two companies.

70


 
 

TABLE OF CONTENTS

Chane Graziano — Director

Mr. Graziano has served as a member of our board of directors since May 3, 2012. Since March 1996, Mr. Graziano has served as the Chief Executive Officer and Chairman of the board of directors of Harvard Bioscience. Mr. Graziano served as the President of Analytical Technology Inc., an analytical electrochemistry instruments company, from 1993 to 1996 and as the President and Chief Executive Officer of its predecessor, Analytical Technology Inc. Orion, an electrochemistry instruments and laboratory products company, from 1990 until 1993. Mr. Graziano served as the President of Waters Corporation, an analytical instrument manufacturer, from 1985 until 1989. Mr. Graziano has over 42 years of experience in the laboratory products and analytical instruments industry. Mr. Graziano currently serves on the boards of directors of Nova Analytics Corporation and Advion BioSciences, Inc.

We believe Mr. Graziano’s qualifications to sit on our board of directors include his executive leadership experience, significant operating and management expertise in the scientific products industry and the extensive knowledge and understanding of our company that he has acquired through his position of Chief Executive Officer and Chairman of the board of directors of Harvard Bioscience.

John F. Kennedy — Director

Mr. Kennedy has served as a member of our board of directors since December 3, 2012. From June 2006 until his retirement in October 2008, Mr. Kennedy served as President and Chief Financial Officer of Nova Ventures Corporation, the management company providing executive management services to the operating companies of Nova Holdings LLC, Nova Analytics Corporation and Nova Technologies Corporation. From 2002 to 2006, Mr. Kennedy served as the President and Chief Financial Officer of Nova Analytics Corporation, a worldwide supplier and integrator of analytical instruments. From 1999 to 2002, Mr. Kennedy served as the Senior Vice President, Finance, Chief Financial Officer and Treasurer of RSA Security Inc., an e-business security company. Prior to joining RSA Security, Mr. Kennedy was Chief Financial Officer of Decalog, NV, a developer of enterprise investment management software, from 1998 to 1999. From 1993 to 1998, Mr. Kennedy served as Vice President of Finance, Chief Financial Officer and Treasurer of Natural MicroSystems Corporation, a telecommunications company. Mr. Kennedy, a former CPA, also practiced as a public accountant at KPMG for six years. Mr. Kennedy currently serves on the boards of directors of Harvard Bioscience and Datacom Systems, Inc. Mr. Kennedy holds an M.S.B.A. in Accounting from the University of Massachusetts Amherst.

We believe Mr. Kennedy’s qualifications to sit on our board of directors include his executive leadership experience, his significant operating, accounting and financial management expertise and the knowledge and understanding of our company and industry that he has acquired over 11 years of service on the board of directors of Harvard Bioscience.

Thomas Robinson — Director

Mr. Robinson has served as a member of our board of directors since December 3, 2012. Since September 2011, Mr. Robinson has served as a partner with RobinsonButler, an executive search firm. In 2010, Mr. Robinson served as managing director at Russell Reynolds Associates. From 1998 to 2010, Mr. Robinson served as managing partner of the North American medical technology practice, which includes the medical device, hospital supply/distribution and medical software areas, of Spencer Stuart, Inc., a global executive search firm. From 2002 to 2010, Mr. Robinson was a member of Spencer Stuart’s board services practice, which assists corporations to identify and recruit outside directors. From 1998 to 2000, Mr. Robinson headed Spencer Stuart’s North American biotechnology specialty practice. From 1993 to 1997, Mr. Robinson served as president of the emerging markets business at Boston Scientific Corporation, a global medical devices manufacturer. From 1991 to 1993, Mr. Robinson also served as president and chief operating officer of Brunswick Biomedical, a cardiology medical device company. Mr. Robinson currently serves on the board of directors of Cynosure, Inc. He received his M.B.A. from Harvard Business School and his B.A. in mathematics and economics from Brown University.

We believe Mr. Robinsons’ qualifications to sit on our board of directors include his executive leadership experience in, and knowledge of, the medical device and regenerative medicine industries, and his significant expertise in the areas of public company corporate governance and operations.

71


 
 

TABLE OF CONTENTS

The Board of Directors Following the Separation

Our business and affairs are managed under the direction of our board of directors. We currently have four directors, two of whom will be considered independent under the independence requirements of the NASDAQ Stock Market. Our directors will have discretion to increase or decrease the size of the board of directors. Our board of directors will be divided into three classes with staggered terms, which means that directors in one of the classes will be elected each for a new three-year term. Class I directors will have an initial term expiring in 2014, Class II directors will have an initial term expiring in 2015 and Class III directors will have an initial term expiring in 2016.

Director Independence

Mr. Kennedy and Mr. Robinson meet NASDAQ’s listing standards for independence. Mr. Green does not meet these standards because he is our employee. Mr. Graziano does not meet NASDAQ’s listing standards for independence because he is the Chief Executive Officer of Harvard Bioscience.

The NASDAQ listing rules require that the board be comprised of a majority of independent directors. We intend to rely on the phase-in-periods provided by Rule 4350(a)(5) of the NASDAQ rules and Rule 10A-3(b)(iv)(A) of the Exchange Act, which provide for phase-in compliance where the issuer has not previously been required to file public company reports under Section 13(a) or 15(d) of the Exchange Act. Accordingly, we plan to have a board of directors comprised of a majority of independent directors and an audit committee comprised solely of independent directors within one year of our listing.

There are no family relationships among any of the individuals who are expected to serve as members of our board of directors and as our executive officers following Harvard Bioscience’s planned distribution of our common stock to its stockholders.

Board Committees

Prior to the consummation of this offering, our board of directors will have an audit committee, a compensation committee and a nominating and corporate governance committee.

The table below provides committee assignments for each of the committees of our board of directors:

     
Name   Audit Committee   Compensation Committee   Nominating and Corporate Governance Committee
John F. Kennedy   X*    
Thomas Robinson        X*   X*

* Indicates Committee Chair

Audit Committee

The audit committee will be established in accordance with Section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended. We are relying on the phase-in-periods provided by Rule 4350(a)(5) of the NASDAQ Rules and Rule 10A-3(b)(iv)(A) of the Exchange Act. Accordingly, we plan to have an audit committee comprised solely of independent directors as defined by the NASDAQ listing standards within one year of our listing, and at least one director will satisfy the definition of audit committee financial expert as determined by the SEC.

The audit committee will be responsible for reviewing and discussing with management our policies with respect to risk assessment and risk management. The board of directors and the audit committee will discuss matters relating to risks that arise or may arise.

Upon completion of this offering, the audit committee will consist of John F. Kennedy. Mr. Kennedy is considered independent under the NASDAQ listing standards and an audit committee financial expert under SEC rules. Prior to the consummation of this offering, our board of directors will adopt a written charter under which the audit committee will operate. A copy of the charter, which will satisfy the applicable standards of the SEC and NASDAQ, will be available without charge on the investor relations portion of our web site.

72


 
 

TABLE OF CONTENTS

Compensation Committee

Each member of the compensation committee will be independent as defined by the NASDAQ listing standards, subject to the phase-in periods provided by Rule 4350(a)(5) of the NASDAQ Rules. Accordingly, we plan to have a Compensation committee comprised solely of independent directors within one year of our listing.

Upon completion of this offering, the compensation committee will consist of John F. Kennedy and Thomas Robinson, each of whom is considered an independent director under the NASDAQ listing standards. Prior to the consummation of this offering, our board of directors will adopt a written charter under which the compensation committee will operate. A copy of the charter, which will satisfy the applicable standards of the SEC and NASDAQ, will be available without charge on the investor relations portion of our web site.

Nominating and Corporate Governance Committee

Upon completion of this offering, the nominating and corporate governance committee will consist of Thomas Robinson and John F. Kennedy, each of whom is considered an independent director under the NASDAQ listing standards. Prior to the consummation of this offering, our board of directors will adopt a written charter under which the nominating and corporate governance committee will operate. A copy of the charter, which will satisfy the applicable standards of the SEC and the NASDAQ Stock Market, will be available without charge on the investor relations portion of our web site.

Board Leadership Structure and the Board’s Role in Risk Oversight

Our board of directors believes that the combined role of Chairman of the Board and Chief Executive Officer promotes and facilitates information flow between management and the board of directors, which is essential to effective governance. Having considered the particular circumstances of our company, including its status as a “controlled company,” the individual attributes of our current directors, including our Chairman of the Board and Chief Executive Officer, the effective manner in which certain of our directors historically have performed their duties as Harvard Bioscience directors, and the critical need for stability and continuity of leadership and decision-making necessary in connection with our separation from Harvard Bioscience, it is our board of directors’ belief that, at this time, there is no need to separate the offices of Chairman of the Board and Chief Executive Officer.

Management is responsible for the day-to-day management of risks we face while the board of directors, as a whole and through its committees, will oversee risk management. The audit committee is responsible for reviewing and discussing with management our policies with respect to risk assessment and risk management. The board of directors and the audit committee will review and discuss, including with management, risks that arise or may arise. For example, the audit committee will discuss financial risk, including with respect to financial reporting and internal controls, with management and our independent registered public accounting firm and the steps management has taken to minimize those risks. Our board of directors will also administer its risk oversight function through the required approval by the board of directors (or a committee of the board of directors) of significant transactions and other material decisions.

Code of Business Conduct and Ethics

Effective upon completion of this offering, our board of directors will adopt a written Code of Business Conduct and Ethics applicable to our directors, chief executive officer, chief financial officer and all other officers and employees of our company and its subsidiaries. Copies of the Code of Business Conduct and Ethics will be available without charge on the investor relations portion of our web site upon completion of this offering or upon request in writing to Harvard Apparatus Regenerative Technology, Inc., 84 October Hill Rd., Holliston, MA 01746, Attention: Corporate Secretary.

Compensation Committee Interlocks and Insider Participation

None of the members of our compensation committee is an officer or employee of our company. David Green currently serves as a member of the board of directors of Harvard Bioscience. Chane Graziano, the Chief Executive Officer of Harvard Bioscience is a member of our board of directors.

73


 
 

TABLE OF CONTENTS

DIRECTOR AND EXECUTIVE COMPENSATION

Board of Directors’ Compensation

No compensation has been paid to our non-employee directors since our inception. Following completion of this offering, we intend to provide compensation to our non-employee directors that will enable us to attract and retain high-quality directors, provide them with compensation at a level that is consistent with our compensation objectives and competitive with market levels of director compensation, and encourage their ownership of our stock to further align their interests with those of our stockholders. Directors who are also our employees will receive no additional compensation for service as a director.

Executive Compensation

As an emerging growth company, we have opted to comply with the executive compensation disclosure rules applicable to “smaller reporting companies” as such term is defined in the rules promulgated under the Securities Act. We have only two executive officers, David Green, our Chief Executive Officer, and Thomas McNaughton, our Chief Financial Officer, who will be our named executive officers. No compensation was paid to our executive officers during the fiscal year ended December 31, 2012. Our officers were paid by Harvard Bioscience and the expense of such compensation was allocated to us in connection with the preparation of our financial statements included in this prospectus. As discussed below in more detail, during the time period following the consummation of this offering and the planned distribution of our common stock by Harvard Bioscience, Messrs. Green and McNaughton will remain employed at both our company and Harvard Bioscience. During this time period, they will continue to be compensated by Harvard Bioscience and 95% of the expense of such compensation for Mr. Green and 30% of the expense of such compensation for Mr. McNaughton will be allocated to us.

Employment Agreements — Named Executive Officers

Prior to the consummation of this offering, we will enter into employment agreements with our named executive officers that will have a term that commences upon the planned distribution of our common stock by Harvard Bioscience. The anticipated material terms of those agreements are summarized below.

David Green

Mr. Green’s employment agreement will have a term of two years, but shall automatically renew for successive two year periods unless either party provides 90 days notice that it does not wish to extend the agreement. Mr. Green’s employment agreement provides for an annual base salary in the amount of five hundred four thousand seven hundred dollars ($504,700) which shall be reevaluated on an annual basis by the board of directors or the compensation committee. Mr. Green will be eligible to receive cash incentive compensation as determined by the board of directors or the compensation committee, and shall also be eligible to participate in all of our employee benefit plans, including without limitation, retirement plans, stock option plans, and medical insurance plans. Mr. Green is also entitled to use a car leased for him by us.

Mr. Green’s employment agreement also provides for payments to be made to Mr. Green in the event of his termination under certain circumstances. If Mr. Green’s employment is terminated by us without “cause” (as such term is defined in Mr. Green’s employment agreement) or by Mr. Green for “good reason” (as such term is defined in Mr. Green’s employment agreement), we are obligated to pay Mr. Green two times the sum of his average annual base salary for the prior three fiscal years or annual salary for the prior fiscal year, whichever is higher, and his average annual cash incentive compensation for the prior three fiscal years or annual cash incentive compensation for the prior fiscal year, whichever is higher. Such payment is conditioned upon Mr. Green’s execution of a general release of claims against us. In addition, all of Mr. Green’s stock options or stock based awards that would otherwise vest within the 24 month period following such termination shall accelerate and become immediately exercisable. We shall continue to pay health insurance premiums for health insurance coverage for Mr. Green and his immediate family for a period of one year following his termination without cause or for good reason.

Mr. Green may also be entitled to certain payments in the event of a change in control of our company. If Mr. Green’s employment is terminated by us without cause or by Mr. Green for good reason within 18 months

74


 
 

TABLE OF CONTENTS

of a change in control of our company, Mr. Green is entitled to receive a lump sum cash payment in an amount equal to three times the sum of Mr. Green’s most recent annual salary and his most recent cash incentive compensation. In addition, in the event of a change in control, all of Mr. Green’s stock options or stock based awards shall accelerate and become immediately exercisable. We shall continue to pay health insurance premiums for health insurance coverage for Mr. Green and his immediate family for a period of one year following his termination as a result of a change in control. Any distribution of the shares of our common stock by Harvard Bioscience to its stockholders will be expressly excluded from the definition of change in control in Mr. Green’s employment agreement.

Mr. Green will not be entitled to severance payments unless mutually agreed upon in writing if Mr. Green is terminated for cause, due to death or disability, or he terminates his employment without good reason. In the event Mr. Green is terminated due to death or disability, we shall continue to pay health insurance premiums for health insurance coverage for Mr. Green and his immediate family for a period of one year following his termination.

Mr. Green is also eligible to receive a gross up payment in the event that any amounts received pursuant to the terms of his employment agreement are subject to the excise tax imposed by Section 4999 of the Internal Revenue Code of 1986, as amended, or any interest or penalties on such excise tax are incurred by Mr. Green. Such payment shall be equal to the amount of (i) the excise tax, (ii) any federal, state or local tax resulting from the gross up payment and (iii) any interest and/or penalties assessed with respect to such excise tax.

Pursuant to the terms of his employment agreement, Mr. Green is also subject to certain confidentiality, non-solicitation and non-competition obligations. The non-solicitation and non-competition obligations survive during the term of his agreement and for a period of 12 months thereafter.

For purposes of Mr. Green’s employment agreement, “cause” shall mean: (A) conduct by Mr. Green constituting a material act of willful misconduct in connection with the performance of his duties; (B) criminal or civil conviction of Mr. Green, a plea of nolo contendere by Mr. Green or conduct by Mr. Green that would reasonably be expected to result in material injury to our reputation if he were retained in his position with us; (C) continued, willful and deliberate non-performance by Mr. Green of his duties; (D) a breach by Mr. Green of his confidentiality, non-solicitation and non-competition obligations to us; or (E) a violation by Mr. Green of our employment policies.

For purposes of Mr. Green’s employment agreement, “good reason” shall mean the occurrence of any of the following events: (A) a substantial diminution or other substantive adverse change, not consented to by Mr. Green, in his responsibilities, powers, or duties; (B) any removal of Mr. Green’s title of President and Chief Executive Officer; (C) an involuntary reduction in Mr. Green’s annual salary except for across-the-board reductions similarly affecting substantially all management employees; (D) a breach by us of any of our other material obligations under Mr. Green’s employment agreement; (E) the involuntary relocation of our offices at which Mr. Green is principally employed to a location more than 30 miles from our current offices; or (F) our failure to obtain the agreement from any successor company to us to assume and agree to perform Mr. Green’s employment agreement.

Thomas McNaughton

Mr. McNaughton’s employment agreement will have a term of two years, but shall automatically renew for successive two year periods unless either party provides 90 days notice that it does not wish to extend the agreement. Mr. McNaughton’s employment agreement provides for an annual base salary in the amount of three hundred nine thousand ($309,000) which shall be reevaluated on an annual basis by the board of directors or the compensation committee. Mr. McNaughton will be eligible to receive cash incentive compensation as determined by the board of directors or the compensation committee, and shall also be eligible to participate in all of our employee benefit plans, including without limitation, retirement plans, stock option plans, stock purchase plans and medical insurance plans.

Mr. McNaughton’s employment agreement also provides for payments to be made to Mr. McNaughton in the event of his termination under certain circumstances. If Mr. McNaughton’s employment is terminated by us without “cause” (as such term is defined in Mr. McNaughton’s employment agreement) or by Mr. McNaughton for “good reason” (as such term is defined in Mr. McNaughton’s employment agreement), we

75


 
 

TABLE OF CONTENTS

are obligated to pay Mr. McNaughton the sum of his average annual base salary for the prior three fiscal years or annual salary for the prior fiscal year, whichever is higher, and his average annual cash incentive compensation for the prior three fiscal years or annual cash incentive compensation for the prior fiscal year, whichever is higher. Such payment is conditioned upon Mr. McNaughton’s execution of a general release of claims against us. In addition, all of Mr. McNaughton’s stock options or stock based awards that would otherwise vest within the 18 month period following such termination shall accelerate and become immediately exercisable. We shall continue to pay health insurance premiums for health insurance coverage for Mr. McNaughton and his immediate family for a period of one year following his termination without cause or for good reason.

Mr. McNaughton may also be entitled to certain payments in the event of a change in control of our company. If Mr. McNaughton’s employment is terminated by us without cause or by Mr. McNaughton for good reason within 18 months of a change in control of our company, Mr. McNaughton is entitled to receive a lump sum cash payment in an amount equal to the sum of Mr. McNaughton’s most recent annual salary and his most recent cash incentive compensation. In addition, in the event of a change in control, all of Mr. McNaughton’s stock options or stock based awards shall accelerate and become immediately exercisable. We shall continue to pay health insurance premiums for health insurance coverage for Mr. McNaughton and his immediate family for a period of one year following his termination as a result of a change in control. Any distribution of the shares of our common stock by Harvard Bioscience to its stockholders will be expressly excluded from the definition of change in control in Mr. McNaughton’s employment agreement.

Mr. McNaughton will not be entitled to severance payments unless mutually agreed upon in writing if Mr. McNaughton is terminated for cause, due to death or disability, or he terminates his employment without good reason. In the event Mr. McNaughton is terminated due to death or disability, we shall continue to pay health insurance premiums for health insurance coverage for Mr. McNaughton and his immediate family for a period of one year following his termination.

Mr. McNaughton is also eligible to receive a gross up payment in the event that any amounts received pursuant to the terms of his employment agreement are subject to the excise tax imposed by Section 4999 of the Internal Revenue Code of 1986, as amended, or any interest or penalties on such excise tax are incurred by Mr. McNaughton. Such payment shall be equal to the amount of (i) the excise tax, (ii) any federal, state or local tax resulting from the gross up payment and (iii) any interest and/or penalties assessed with respect to such excise tax.

Pursuant to the terms of his employment agreement, Mr. McNaughton is also subject to certain confidentiality, non-solicitation and non-competition obligations. The non-solicitation and non-competition obligations survive during the term of his agreement and for a period of 12 months thereafter.

For purposes of Mr. McNaughton’s employment agreement, “cause” shall mean: (A) conduct by Mr. McNaughton constituting a material act of willful misconduct in connection with the performance of his duties; (B) criminal or civil conviction of Mr. McNaughton, a plea of nolo contendere by Mr. McNaughton or conduct by Mr. McNaughton that would reasonably be expected to result in material injury to our reputation if he were retained in his position with us; (C) continued, willful and deliberate non-performance by Mr. McNaughton of his duties; (D) a breach by Mr. McNaughton of his confidentiality, non-solicitation and non-competition obligations to us; or (E) a violation by Mr. McNaughton of our employment policies.

For purposes of Mr. McNaughton’s employment agreement, “good reason” shall mean the occurrence of any of the following events: (A) a substantial diminution or other substantive adverse change, not consented to by Mr. McNaughton, in his responsibilities, powers, or duties; (B) any removal of Mr. McNaughton’s title of Chief Financial Officer; (C) an involuntary reduction in Mr. McNaughton’s annual salary except for across-the-board reductions similarly affecting substantially all management employees; (D) a breach by us of any of our other material obligations under Mr. McNaughton’s employment agreement; (E) the involuntary relocation of our offices at which Mr. McNaughton is principally employed to a location more than 30 miles from our current offices; or (F) our failure to obtain the agreement from any successor company to us to assume and agree to perform Mr. McNaughton’s employment agreement.

76


 
 

TABLE OF CONTENTS

IPO Grants

Prior to the consummation of this offering, our compensation committee and independent directors plan to grant stock options to acquire our common stock with an exercise price equal to the initial public offering price to our named executive officers and certain other employees.

These grants are intended to:

provide the named executive officers and other employees receiving grants an immediate equity interest in our company in order to align their interests with those of our stockholders; and
induce certain of the named executive officers to execute their employment agreements with our company pertaining to their executive roles at our company, the term of which will commence at the time of the planned distribution our common stock by Harvard Bioscience, and to waive their rights under their employment agreements with Harvard Bioscience to terminate their employment for “good reason” due to a substantial diminution or other substantive adverse change in their responsibilities, powers, or duties arising from their new roles at our company.

The option grants to our named executive officers are described below:

   
  Value   Options
David Green   $                  
Thomas McNaughton   $           
All Named Executive Officers   $           

The number of stock options to be granted to named executive officers will be based on a percentage of our company’s outstanding common stock. The Black-Scholes value of our stock options will be based on a number of assumptions, including an exercise price equal to $    , which is the midpoint of the range set forth on the cover page of this prospectus. The actual exercise price of the stock options granted pursuant to such grants will be the initial public offering price. Such option grants will become effective as of, and are conditioned upon, the determination of the initial public offering price.

Treatment of Outstanding Harvard Bioscience Equity Awards

Following completion of this offering, all outstanding Harvard Bioscience stock options and restricted stock units will remain outstanding and will not be modified. At the time of Harvard Bioscience’s distribution of our common stock it then owns, holders of Harvard Bioscience stock options and restricted stock units issued previously to employees and directors as part of Harvard Bioscience’s equity compensation plans will receive an adjustment to their stock options and restricted stock units because those securities will not participate in the distribution. The adjustments will be based on the estimated value of the entire distribution, as measured by the relationship between Harvard Bioscience’s common stock price just prior to and after the distribution. We expect that, for adjustments to the quantity of outstanding stock options and restricted stock units, Harvard Bioscience will provide 80% of the value of the adjustment by issuing the holder additional Harvard Bioscience restricted stock units and options for shares of Harvard Bioscience common stock and 20% of the value of the adjustment will be provided by us issuing restricted stock units and options for shares of our common stock. Such modified awards will otherwise have substantially identical terms, including term and vesting provisions, as the existing Harvard Bioscience equity awards. The continued vesting and exercisability of the stock options and restricted stock units will be conditioned on the recipient’s continued service to or employment with Harvard Bioscience or our company.

Separately, certain of our employees and directors, including our executive officers, are holders of vested and unvested options to buy Harvard Bioscience common stock and unvested restricted stock units pertaining to Harvard Bioscience’s common stock. Vesting and exercisability of such options and restricted stock units will continue through their original expiration dates so long as the individual holder is employed or providing service to us or Harvard Bioscience.

77


 
 

TABLE OF CONTENTS

With respect to individual owners of both options and/or restricted stock units issued by our company and those issued by Harvard Bioscience, the compensation expense for such options and restricted stock units will be recognized by the company receiving the individual’s services. However, cash proceeds from the future option exercises will be realized by the company that issued the respective option.

Employment Benefit Plans

2013 Equity Incentive Plan

On       , 2013, our sole stockholder and board of directors approved our 2013 Equity Incentive Plan, or 2013 Plan, pursuant to which our board of directors can grant incentive stock options, non-qualified stock options, stock appreciation rights, deferred stock awards, restricted stock awards, unrestricted stock awards, performance shares and dividend equivalent rights to employees, directors and consultants. In addition, the issuance of awards in partial substitution for equity awards of common stock of Harvard Bioscience immediately prior to the spin-off of our company by Harvard Bioscience are authorized to be issued under the 2013 Plan.

Shares Available .  The maximum number of shares authorized for issuance under the 2013 Plan is       shares of common stock. The shares underlying any awards that are forfeited, canceled or are otherwise terminated (other than by exercise) under the 2013 Plan will be added back to the shares authorized for issuance under the 2013 Plan. Shares tendered or held back upon exercise of an option or settlement of an award to cover the exercise price or tax withholding are not available for future issuance under the 2013 Plan. In addition, upon exercise of stock appreciation rights, the gross number of shares exercised shall be deducted from the total number of shares remaining available for issuance under the 2013 Plan. The share reserve under the 2013 Plan would be reduced by       shares for each share that underlies an award granted under our 2013 Plan for deferred stock awards of restricted stock units, restricted stock awards, unrestricted stock awards, performance share awards or other awards under our 2013 Plan for which the full value of such share is transferred by us to the award recipient.

Plan Administration .  The 2013 Plan will be administered by the compensation committee of the board of directors. The administrator of the 2013 Plan has full power and authority to select the participants to whom awards will be granted, to make any combination of awards to participants, to accelerate the exercisability or vesting of any award, subject to limitations, and to determine the specific terms and conditions of each award, subject to the provisions of the 2013 Plan. The administrator may delegate to the Chief Executive Officer the authority to grant awards to employees, other than our executive officers, provided that the administrator includes a limitation as to the number of shares that may be awarded and provides specific guidelines regarding such awards.

Eligibility and Limitations on Grants .  All full-time and part-time officers, employees, non-employee directors and other key persons, including consultants, are eligible to participate in the 2013 Plan, subject to the discretion of the administrator. Approximately, individuals are currently eligible to participate in the 2013 Plan.

Performance-Based Compensation .  To ensure that certain awards granted under the 2013 Plan, including awards of restricted stock, deferred stock, cash-based awards or performance shares to a “Covered Employee” (as defined in the Code) qualify as “performance-based compensation” under Section 162(m) of the Code, the 2013 Plan provides that the compensation committee may require that the vesting of such awards be conditioned on the satisfaction of performance criteria including: (1) return on equity, assets, capital or investment; (2) pre-tax or after-tax profit levels; (3) cash flow, funds from operations or similar measure; (4) total shareholder return; (5) changes in the market price of the our common stock; (6) revenues, sales or market share; (7) net income (loss) or earnings per share; (8) expense margins or operating efficiency (including budgeted spending limits) or (9) project development milestones, any of which may be measured either in absolute terms or as compared to any incremental increase or as compared to results of a peer group and, for financial measures, may be based on numbers calculated in accordance with U.S. generally accepted accounting principles or on an as adjusted basis. These performance criteria may be expressed in terms of overall company performance or the performance of a division, business unit, or an individual. The compensation committee will select the particular performance criteria within 90 days following the commencement of a performance cycle, and each performance cycle must be at least three months long.

78


 
 

TABLE OF CONTENTS

Subject to adjustments for stock splits and similar events, the maximum award of restricted stock or deferred stock or performance shares (or combination thereof) granted to any one individual that is intended to qualify as “performance-based compensation” under Section 162(m) of the Code will not exceed 1,000,000 shares, or $2,000,000 in the case of a performance-based award that is a cash-based award for any performance cycle, and options or stock appreciation rights with respect to no more than 1,000,000 shares may be granted to any one individual during any calendar year period.

Stock Options .  The exercise price of stock options awarded under the 2013 Plan may not be less than the fair market value of the common stock on the date of the option grant. The term of each stock option may not exceed ten years from the date of grant. The administrator will determine at what time or times each option may be exercised and, subject to the provisions of the 2013 Plan, the period of time, if any, after retirement, death, disability or termination of employment during which options may be exercised.

To qualify as incentive stock options, stock options must meet additional federal tax requirements, including a $100,000 limit on the value of shares subject to incentive stock options which first become exercisable in any one calendar year, and a shorter term and higher minimum exercise price in the case of certain stockholders that hold more than ten percent of the combined voting power of all classes of our stock.

Automatic Grants to Non-Employee Directors .  The 2013 Plan provides for the automatic grant of a non-qualified stock option to purchase       shares of common stock to non-employee directors on the fifth day after being initially elected to the our board of directors. The exercise price of the automatically granted stock options is equal to 100% of the fair market value of the common stock on the date of grant and, unless otherwise provided by the administrator, one-third of any such stock option grant becomes exercisable on each of the first through third anniversaries of the date of grant. The automatically granted stock options expire ten years after the date of grant.

Stock Appreciation Rights .  The administrator may award a stock appreciation right independently of a stock option. The administrator may award stock appreciation rights subject to such conditions and restrictions as the administrator may determine, provided that the exercise price may not be less than the fair market value of the common stock on the date of grant and no stock appreciation right may be exercisable more than ten years after the date of grant. Additionally, during the participant’s lifetime, all stock appreciation rights are exercisable only by the participant or the participant’s legal representative.

Restricted Stock .  The administrator may award shares to participants subject to such conditions and restrictions as the administrator may determine. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with our company through a specified restricted period. However, in the event these awards to employees have a performance-based goal, the restriction period will be at least one year, and in the event these awards to employees have a time-based restriction, the restriction period will be at least three years.

Deferred Stock .  The administrator may award phantom stock units to participants subject to such conditions and restrictions as the administrator may determine. These conditions and restrictions may include the achievement of certain performance goals and/or continued employment with our company through a specified restricted period. However, in the event these awards to employees have a performance-based goal, the restriction period will be at least one year, and in the event these awards to employees have a time-based restriction, the restriction period will be at least three years. At the end of the deferral period, the participants shall be paid, to the extent vested, in shares.

Unrestricted Stock .  The administrator may grant shares (at par value or for a purchase price determined by the administrator) that are free from any restrictions under the 2013 Plan. Unrestricted stock may be issued to participants in recognition of past services or other valid consideration, and may be issued in lieu of cash compensation to be paid to such individuals.

Performance Shares .  The administrator may grant performance share awards that entitle the recipient to acquire shares of common stock upon the attainment of specified performance goals. The administrator determines the performance goals, performance periods and other terms of any such awards. However, performance share awards to employees will have a restriction period of at least one year.

79


 
 

TABLE OF CONTENTS

Cash-Based Awards .  Each cash-based award shall specify a cash-denominated payment amount, formula or payment ranges as determined by the administrator. Payment, if any, with respect to a cash-based award may be made in cash or in shares of common stock, as the administrator determines.

Dividend Equivalent Rights .  The administrator may award dividend equivalent rights under the 2013 Plan subject to such conditions and restrictions as the administrator may determine, provided that dividend equivalent rights may only be granted in tandem with restricted stock awards, deferred stock awards, performance share awards or unrestricted stock awards. Dividend equivalents credited to the holder may be paid currently or may be deemed to be reinvested in additional shares of stock, which may thereafter accrue additional equivalents.

Tax Withholding .  Participants in the 2013 Plan are responsible for the payment of any federal, state or local taxes that we are required by law to withhold upon any option exercise or vesting of other awards. Subject to approval by the administrator, participants may elect to have the minimum tax withholding obligations satisfied either by authorizing us to withhold shares to be issued pursuant to an option exercise or other award, or by transferring to us shares having a value equal to the amount of such taxes.

Change of Control Provisions .  In the event of a merger, sale or dissolution of our company, or a similar “sale event” (as defined in the 2013 Plan) and upon a change of control all outstanding awards under the 2013 Plan, unless otherwise provided for in a particular award agreement, all stock options and stock appreciation rights will automatically become fully exercisable and all other awards with conditions and restrictions relating solely to the passage of time will become fully vested and non-forfeitable as of the effective time of the sale event or change of control, except as may be otherwise provided in the relevant award agreement. The term change of control is defined in the 2013 Plan and generally refers to any person becoming the beneficial owner of more than twenty five percent voting power of our securities having the right to vote in an election of our board of directors, our board of directors at the time of the offering (or those added by approval of such directors) ceasing for any reason to constitute at least a majority of our board of directors, the consummation of a consolidation, merger or consolidation or sale or other disposition of all or substantially all of our assets, and/or the approval by our stockholders of any plan or proposal for the liquidation or dissolution of us. In addition, upon a sale event, all outstanding awards under the 2013 Plan will terminate unless the parties to the transaction, in their discretion, provide for assumption, continuation or appropriate substitutions or adjustments of such awards. In the event of such termination in connection with a sale event, each holder of an option or a stock appreciation right will be permitted to exercise such award for a specified period prior to the consummation of the sale event. The administrator may also provide for a cash payment with respect to outstanding options and stock appreciation rights in exchange for the cancellation of such awards.

Term .  No awards of incentive stock options may be granted under the 2013 Plan after the 10-year anniversary of the date that the 2013 Plan was approved by the board of directors. No other awards may be granted under the 2013 Plan after the 10-year anniversary of the date that the 2013 Plan was approved by stockholders.

Amendments .  Stockholder approval will be required to amend the 2013 Plan if the administrator determines that this approval is required to ensure that incentive stock options qualify as such under the Code, or that compensation earned under awards qualifies as performance-based compensation under the Code or as required under the applicable securities exchange or market system rules. Otherwise, the board of directors may amend or discontinue the 2013 Plan at any time, and the administrator may amend or cancel any outstanding award for the purpose of satisfying changes in law or for any other lawful purpose, provided that no such amendment may adversely affect the rights under any outstanding award without the holder’s consent.

Repricing .  Other than in the event of a necessary adjustment in connection with a change in our stock or a merger or similar transaction, the administrator may not “reprice” or otherwise reduce the exercise price of outstanding stock options or stock appreciation rights without stockholder approval.

80


 
 

TABLE OF CONTENTS

Employee Stock Purchase Plan

On      , 2013, our sole stockholder and board of directors approved the 2013 employee stock purchase plan. Under this plan, participating employees can authorize us to withhold a portion of their base pay during consecutive six-month payment periods for the purchase of shares of our common stock. Under this plan,       shares of common stock are authorized for issuance. The first offering under the this will commence on       and end on      . Subsequent offerings will commence on each January 1 and July 1 thereafter and will have a duration of six months. Generally, all employees who are customarily employed for more than 20 hours per week as of the first day of the applicable offering period are eligible to participate in the plan. Any employee who owns or is deemed to own shares of stock representing in excess of 5% of the combined voting power of all classes of our stock may not participate in the plan. During each offering, a participating employee may purchase shares under the plan by authorizing payroll deductions of up to 10% of his cash compensation during the offering period. Unless the employee has previously withdrawn from the offering, his accumulated payroll deductions will be used to purchase shares of our common stock on the last business day of the period at a price equal to 85% of the fair market value of our common stock on the first or last day of the offering period, whichever is lower. Under applicable tax rules, an employee may purchase no more than $25,000 worth of our common stock in any calendar year under the plan. We have not issued any shares to date under the plan.

81


 
 

TABLE OF CONTENTS

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

Transactions with Related Persons

Our audit committee charter will set forth the standards, policies and procedures that we follow for the review, approval or ratification of any related person transaction that we are required to report pursuant to Item 404(a) of Regulation S-K promulgated by the SEC. Under the audit committee charter, which will be in writing, the audit committee must conduct an appropriate review of these related person transactions on an ongoing basis, and the approval of the audit committee is required for all such transactions. The audit committee relies on management to identify related person transactions and bring them to the attention of the audit committee. We do not have any formal policies and procedures regarding the identification by management of related person transactions.

Employment Agreements

Prior to the consummation of this offering, we will have entered into employment agreements with our named executive officers that will have a term that commences upon the planned distribution of our common stock by Harvard Bioscience following this offering. For more information regarding our agreements with our Chief Executive Officer and Chief Financial Officer, see “Director and Executive Compensation.”

Indemnification Agreements

We have entered into or plan to enter into indemnification agreements with each of our directors and executive officers, the form of which is attached as an exhibit to the registration statement of which this prospectus is a part. These agreements provide that we will, among other things, indemnify and advance expenses to our directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by any such person in any action or proceeding, including any action by us arising out of such person’s services as our director or officer, or any other company or enterprise to which the person provides services at our request. We believe that these agreements are necessary to attract and retain qualified persons as directors and officers.

Our Relationship with Harvard Bioscience

Prior to this offering we are a wholly-owned subsidiary of Harvard Bioscience. Immediately following this offering, Harvard Bioscience will own at least eighty percent of our outstanding common stock and Harvard Bioscience will continue to control our operations through such ownership. Harvard Bioscience plans to distribute all of the shares of our common stock it then owns to Harvard Bioscience’s stockholders on or after the date that is four months after the completion of this offering by means of a spin-off, which is a pro rata distribution by Harvard Bioscience of the shares of our common stock it owns to holders of Harvard Bioscience’s common stock. At such point Harvard Bioscience will no longer be a stockholder of our common stock and will no longer control our operations.

Directors and Officers of Harvard Bioscience

Some of our directors and officers continue to serve as directors and officers of Harvard Bioscience, our parent company. David Green, our President and Chief Executive Officer and Chairman of our board of directors, currently serves as the President and a director of Harvard Bioscience. Thomas McNaughton serves as the Chief Financial Officer of Harvard Bioscience as well as our Chief Financial Officer. It is anticipated that Messrs. Green and McNaughton will resign as officers of Harvard Bioscience at the time of the planned distribution of our common stock by Harvard Bioscience. Mr. Green intends to remain a director of Harvard Bioscience following this offering and such planned distribution. Chane Graziano, one of our directors, serves as the Chief Executive Officer and Chairman of the board of directors of Harvard Bioscience and intends to continue in such positions following this offering and such planned distribution. John F. Kennedy, one of our directors, is a director of Harvard Bioscience and intends to continue in such position following this offering and such planned distribution.

82


 
 

TABLE OF CONTENTS

Agreements with Harvard Bioscience

Before our separation from Harvard Bioscience, subject to the respective approval of our board of directors and the board of directors of Harvard Bioscience, we will enter into a separation and distribution agreement and several other agreements with Harvard Bioscience to effect the separation and provide a framework for our relationships with Harvard Bioscience after the separation. These agreements will govern the relationships between us and Harvard Bioscience subsequent to the completion of the separation plan and provide for the allocation between us and Harvard Bioscience of Harvard Bioscience’s assets, liabilities and obligations (including employee benefits and tax-related assets and liabilities) related to its regenerative medicine device business, attributable to periods prior to our separation from Harvard Bioscience. In addition to the separation and distribution agreement, which contains many of the key provisions related to our separation from Harvard Bioscience and the distribution of our shares of common stock to Harvard Bioscience stockholders, these agreements include:

an intellectual property matters agreement;
a product distribution agreement;
a tax sharing agreement;
a transition services agreement;
a sublicense agreement; and
a sublease agreement.

The principal agreements described below are filed as exhibits to this prospectus, and the summaries of each of these agreements below set forth the terms of the agreements that we believe are material. These summaries are qualified in their entireties by reference to the full text of the applicable agreements, which are incorporated by reference into this prospectus.

The terms of the agreements described below that will be in effect following our separation have not yet been finalized; changes, some of which may be material, may be made prior to our separation from Harvard Bioscience.

Intellectual Property Matters Agreement

The intellectual property matters agreement governs various arrangements between us and Harvard Bioscience. The agreement provides for the transfer by Harvard Bioscience of all patents, patent applications and inventions not yet filed as patents, as well as any other trade secrets or know-how, that were originated in our business following our establishment as a division of Harvard Bioscience. The agreement also provides for cross-licenses whereby we will have a worldwide royalty free license to use in our business certain of Harvard Bioscience’s currently existing intellectual property, technology and know-how, and Harvard Bioscience will have a worldwide royalty free license to use in certain of its businesses our currently existing intellectual property, technology and know-how. The transfer of the intellectual property from Harvard Bioscience to us that was originated in our business and the cross-licenses described above shall remain in effect in perpetuity.

In addition, in accordance with the intellectual property matters agreement, we will grant Harvard Bioscience an exclusive, worldwide license to use that intellectual property, including any technology or intellectual property developed in the future for a certain period of time following the date of the agreement, for use within the industries and fields in which Harvard Bioscience is currently operating now and in the future, excluding the fields and industries in which we operate. Generally speaking, Harvard Bioscience develops, manufactures and sells life science research tools for research applications. In addition, Harvard Bioscience will grant to us an exclusive, worldwide license to all technology or intellectual property developed in certain divisions of its business in the future for a certain period of time following the date of the agreement, for use within the industries and fields in which we operate. Such licenses are subject to expiration in the event the licensee ceases to actively use the licensed technology or suffers certain insolvency events, as well as upon the expiration of patents that may be included in the licensed technology. Such licenses will be royalty-free for a period of five years following the date of the agreement, provided the parties have agreed that if following such royalty-free five year period, a licensee desires to continue the license, the parties will negotiate in good faith the payment terms and conditions of a continued license.

83


 
 

TABLE OF CONTENTS

The intellectual property matters agreement also provides that for a period of ten years following the date of the agreement, each company will be subject to non-competition and non-solication provisions which restrict its ability to compete with the other company in such company’s respective field as well as soliciting and hiring employees of the other company under certain circumstances.

Product Distribution Agreement

We have entered into a product distribution agreement with Harvard Bioscience pursuant to which each company will become the exclusive distributor for the other party for products such other party develops for sale in the markets served by the other. The product distribution agreement has an initial term of ten years, provided that either party may terminate the agreement earlier in the case of material breach by the other party and certain other instances pertaining to insolvency events impacting a party.

Separation and Distribution Agreement

The separation and distribution agreement sets forth the agreements between us and Harvard Bioscience regarding the principal corporate transactions required to effect our separation from Harvard Bioscience, this offering and the distribution, if any, of our shares to Harvard Bioscience’s stockholders, and other agreements governing the relationship between Harvard Bioscience and us.

The Separation

The separation and distribution agreement will identify assets to be transferred, liabilities to be assumed and contracts to be assigned to each of us and Harvard Bioscience as part of the separation of Harvard Bioscience into two companies, and it will provide for when and how these transfers, assumptions and assignments will occur. In particular, the separation and distribution agreement will provide, among other things, that, subject to the terms and conditions contained therein:

certain assets related to the businesses and operations of Harvard Bioscience’s regenerative medicine device business, which we refer to as the HART Assets, will be transferred to us or one of our subsidiaries;
certain liabilities (including whether accrued, contingent or otherwise) arising out of or resulting from the HART Assets, and other liabilities related to the businesses and operations of Harvard Bioscience’s regenerative medicine device business, which we refer to as the HART Liabilities, will be retained by or transferred to us or one of our subsidiaries;
all of the assets and liabilities (including whether accrued, contingent or otherwise) other than the HART Assets and HART Liabilities (such assets and liabilities, other than the HART Assets and the HART Liabilities, are referred to as the Excluded Assets and Excluded Liabilities, respectively) will be retained by or transferred to Harvard Bioscience or one of its subsidiaries; and
certain shared contracts will be assigned, in part to us or our applicable subsidiaries or be appropriately amended.

Except as may expressly be set forth in the separation and distribution agreement or any other transaction agreements, all assets will be transferred on an “as is,” “where is” basis and the respective transferees will bear the economic and legal risks that (1) any conveyance will prove to be insufficient to vest in the transferee good title, free and clear of any security interest, and (2) any necessary consents or governmental approvals are not obtained or that any requirements of laws or judgments are not complied with.

Information in this prospectus with respect to the assets and liabilities of the parties following the separation is presented based on the allocation of such assets and liabilities pursuant to the separation and distribution agreement, unless the context otherwise requires. Certain of the liabilities and obligations to be assumed by one party or for which one party will have an indemnification obligation under the separation and distribution agreement and the other transaction agreements relating to the separation are, and following the separation may continue to be, the legal or contractual liabilities or obligations of the other party. Each party that continues to be subject to such legal or contractual liability or obligation will rely on the applicable party that assumed the liability or obligation or the applicable party that undertook an indemnification obligation with

84


 
 

TABLE OF CONTENTS

respect to the liability or obligation, as applicable, under the separation and distribution agreement to satisfy the performance and payment obligations or indemnification obligations with respect to such legal or contractual liability or obligation.

Claims

In general, each party to the separation and distribution agreement will assume liability for all pending, threatened and unasserted legal matters related to its own business or its assumed or retained liabilities and will indemnify the other party for any liability to the extent arising out of or resulting from such assumed or retained legal matters.

Intercompany Accounts

The separation and distribution agreement will provide that, subject to any provisions in the separation and distribution agreement or any other transaction agreement to the contrary, at or prior to the distribution of our common stock, all intercompany accounts between Harvard Bioscience and its subsidiaries, on the one hand, and our company and our subsidiaries, on the other hand, will be settled.

Further Assurances

To the extent that any transfers contemplated by the separation and distribution agreement have not been consummated on or prior to the date of the separation, the parties will agree to cooperate to effect such transfers as promptly as practicable following the date of the separation. In addition, each of the parties will agree to cooperate with the other party and use commercially reasonable efforts to take or to cause to be taken all actions, and to do, or to cause to be done, all things reasonably necessary under applicable law or contractual obligations to consummate and make effective the transactions contemplated by the separation and distribution agreement and the other transaction agreements.

Initial Public Offering

For a description of Harvard Bioscience’s ownership in us after completion of this offering, see “Principal Stockholders.”

The separation and distribution agreement will provide that the separation and this offering are subject to the satisfaction (or waiver by Harvard Bioscience in its sole discretion) of the following conditions:

the completion of the separation and the related transactions in accordance with the plan of reorganization set forth in the separation and distribution agreement;
the SEC declaring effective our registration statement on Form S-1, of which this prospectus is a part;
our receipt of approximately $10 million in cash from Harvard Bioscience;
all actions and filings necessary or appropriate under federal, state or foreign securities laws have been taken and, where applicable, become effective or been accepted by the applicable governmental authority;
the approval for listing on the NASDAQ Capital Market of the shares of our common stock being sold in this offering;
the transaction agreements relating to the separation have been duly executed and delivered by the parties;
we have entered into the underwriting agreement and all conditions to our obligations and the underwriters’ obligations under the underwriting agreement will have been satisfied or waived;
Harvard Bioscience is satisfied in its sole discretion that it will own at least 80% of our stock on a fully diluted basis, and Harvard Bioscience is satisfied in its sole discretion that all other conditions to the distribution qualifying as a tax-free distribution to Harvard Bioscience, us and Harvard Bioscience’s stockholders, to the extent applicable, as of the time of this offering, are satisfied and there is not any event or condition that is likely to cause any of such conditions not to be satisfied as of the time of the distribution or thereafter;

85


 
 

TABLE OF CONTENTS

no order, injunction or decree issued by any court of competent jurisdiction or other legal restraint or prohibition preventing consummation of the separation or this offering or any of the related transactions is in effect;
such other actions as Harvard Bioscience or we may, based upon the advice of counsel, reasonably request to be taken prior to the separation and this offering in order to assure the successful completion of the separation and this offering and the other transactions contemplated by the separation and distribution agreement will have been taken;
no termination of the separation and distribution agreement has occurred; and
no event or development has occurred or existed or is expected to occur that, in the judgment of the Harvard Bioscience board of directors, in its sole discretion, makes it inadvisable to effect the separation or this offering.

The Distribution

The separation and distribution agreement also governs the rights and obligations of Harvard Bioscience and our company regarding the proposed distribution by Harvard Bioscience to its stockholders of the shares of our common stock held by Harvard Bioscience following this offering, which we also refer to in this prospectus as the distribution. Harvard Bioscience expects to accomplish this distribution through a spin-off, which is a pro rata distribution by Harvard Bioscience of its shares of our common stock to holders of Harvard Bioscience’s common stock. There are various conditions to the completion of the distribution. In addition, Harvard Bioscience may terminate its obligation to complete the distribution at any time if the Harvard Bioscience board of directors, in its sole discretion, determines that the distribution is not in the best interests of Harvard Bioscience or its stockholders. Consequently, we cannot assure you as to when or whether the distribution will occur.

The separation and distribution agreement provides that Harvard Bioscience’s obligation to complete the distribution is subject to several conditions that must be satisfied (or waived by Harvard Bioscience in its sole discretion), including, among others:

Harvard Bioscience receives a private letter ruling from the IRS to the effect that, among other things, the contribution by Harvard Bioscience of the regenerative medicine device business to us and the distribution will qualify as a transaction that is tax-free for U.S. federal income tax purposes under Section 355 and 368(a)(1)(D) of the Internal Revenue Code continuing in effect, and Harvard Bioscience’s receipt of an opinion from Burns & Levinson LLP, counsel to Harvard Bioscience, to the effect that the contribution and distribution will qualify as a transaction that is described in Section 355 and 368(a)(1)(D) of the Internal Revenue Code;
all governmental approvals necessary to consummate the distribution have been obtained and are in full force and effect;
all actions and filings necessary or appropriate under applicable securities laws in connection with the distribution will have been taken or made, and, where applicable, become effective or been accepted by the applicable governmental authority;
the approval for listing on the NASDAQ Capital Market of the shares of our common stock to be distributed to the Harvard Bioscience stockholders in the distribution;
no order, injunction or decree issued by any court or agency of competent jurisdiction or other legal restraint or prohibition preventing consummation of the distribution or any of the related transactions are in effect, and no other event outside the control of Harvard Bioscience has occurred or failed to occur that prevents the consummation of the distribution or any of the related transactions; and
no other events or developments have occurred subsequent to the completion of this offering that, in the judgment of the Harvard Bioscience board of directors, would result in the distribution not being in the best interest of Harvard Bioscience or its stockholders.

Harvard Bioscience has the right to terminate its obligation to complete the distribution if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the distribution is not in the

86


 
 

TABLE OF CONTENTS

best interests of Harvard Bioscience or its stockholders. In the event of such termination following the separation, neither party will have any liability to the other party under the separation and distribution agreement in respect of the distribution.

We will cooperate with Harvard Bioscience to accomplish the distribution and will, at Harvard Bioscience’s direction, promptly take any and all actions necessary or desirable to effect the distribution, including, without limitation, the registration under the Securities Act of our common stock on an appropriate registration form or forms to be designated by Harvard Bioscience.

Covenants

We have agreed that, for so long as Harvard Bioscience beneficially owns at least 50 percent of the total voting power of our outstanding capital stock entitled to vote in the election of our board of directors, we will not (without Harvard Bioscience’s prior written consent):

take any action that would limit the ability of Harvard Bioscience to transfer its shares of our common stock or limit the rights of any transferee of Harvard Bioscience as a holder of our common stock;
if Harvard Bioscience beneficially owns at least 80% of the total voting power of our outstanding capital stock entitled to vote in the election of our board of directors, issue any shares of our capital stock or any rights, warrants or options to acquire our common stock if this could cause Harvard Bioscience to own (1) less than 80% of the total voting power of our outstanding capital stock entitled to vote in the election of our board of directors, (2) less than 80% of any class of capital stock not entitled to vote in the election of our board of directors, or (3) less than 80% of the value of our outstanding capital stock;
take any actions that could reasonably result in Harvard Bioscience being in breach of or in default under any contract or agreement;
incur any indebtedness that could be reasonably likely to adversely impact the credit rating of any indebtedness of Harvard Bioscience;
acquire any other businesses or assets or dispose of any of our assets, in each case with an aggregate value for all such transactions in excess of $20 million; or
acquire any equity interests in, or loan any funds to, third parties in excess of $10 million in the aggregate.

Employee Matters

The separation and distribution agreement will also allocate liabilities and responsibilities relating to employee compensation, benefit plans, programs and other related matters in connection with the separation, including the treatment of outstanding incentive awards and certain retirement and welfare benefit obligations. The separation and distribution agreement provides for certain adjustments with respect to Harvard Bioscience equity compensation awards that will occur when Harvard Bioscience completes the distribution. Such adjustment is required under the Harvard Bioscience employee benefit plans and it is anticipated that each outstanding Harvard Bioscience option to purchase Harvard Bioscience common stock shall be converted on the date of the distribution into both an adjusted Harvard Bioscience option to purchase Harvard Bioscience common stock and an option to purchase our common stock. It is currently anticipated that Black-Scholes valuation modeling will be used to determine the value that each Harvard Bioscience option has lost at the time of the distribution and then to ensure the holder maintains such lost value, 80% of such lost value will be provided back to the holder by making appropriate adjustments to the share amount and exercise price of the existing Harvard Bioscience option and 20% of such lost value will be provided back to the holder through the issuance of an option to purchase our common stock. The share amounts and exercise prices of the adjusted Harvard Bioscience options and our options would be adjusted in a manner to ensure the intrinsic value held by the holder pertaining to the existing Harvard Bioscience award is maintained immediately following the distribution and shall be determined such that tax is not triggered under Section 409A of the Internal Revenue Code.

87


 
 

TABLE OF CONTENTS

Similar to the adjustment of the existing Harvard Bioscience options, with respect to each unvested Harvard Bioscience restricted stock unit outstanding at the time of the distribution, such Harvard Bioscience restricted stock unit shall be converted on the distribution date into both an adjusted Harvard Bioscience restricted stock unit and a restricted stock unit in our company. Immediately following the distribution, the market prices of Harvard Bioscience and our common stock will be used to determine the value that each Harvard Bioscience restricted stock unit lost at the time of the distribution and then to ensure the holder maintains such lost value, 80% of such lost value will be provided back to the holder by making appropriate increase of the share amount of the existing Harvard Bioscience restricted stock unit and 20% of such lost value will be provided back to the holder through the issuance of our restricted stock unit. The share amounts of the adjusted Harvard Bioscience restricted stock unit and our restricted stock unit would be set in a manner to ensure the intrinsic value held by the holder pertaining to the existing Harvard Bioscience award is maintained immediately following the distribution and shall be determined such that tax is not triggered under Section 409A of the Internal Revenue Code.

Auditors and Audits; Annual Financial Statements and Accounting

We have agreed that, for so long as Harvard Bioscience is required to consolidate our results of operations and financial position or account for its investment in our company under the equity method of accounting, we will:

not change our independent auditors without Harvard Bioscience’s prior written consent;
use our best efforts to enable our independent auditors to complete their audit of our financial statements in a timely manner so as to permit timely filing of Harvard Bioscience’s financial statements;
provide to Harvard Bioscience and its independent auditors all information required for Harvard Bioscience to meet its schedule for the filing and distribution of its financial statements and to make available to Harvard Bioscience and its independent auditors all documents necessary for the annual audit of our company as well as access to the responsible company personnel so that Harvard Bioscience and its independent auditors may conduct their audits relating to our financial statements;
adhere to certain specified Harvard Bioscience accounting policies and notify and consult with Harvard Bioscience regarding any changes to our accounting principles and estimates used in the preparation of our financial statements, and any deficiencies in, or violations of law in connection with, our internal control over financial reporting; and
consult with Harvard Bioscience regarding the timing and content of our earnings releases and cooperate fully (and cause our independent auditors to cooperate fully) with Harvard Bioscience in connection with any of its public filings.

Releases

Except as otherwise provided in the separation and distribution agreement or any other transaction agreements, each party will release and forever discharge the other party and its respective subsidiaries and affiliates from all liabilities existing or arising from any acts or events occurring or failing to occur or alleged to have occurred or to have failed to occur or any conditions existing or alleged to have existed on or before the separation from Harvard Bioscience. The releases will not extend to obligations or liabilities under any agreements between the parties that remain in effect following the separation, which agreements include, but are not limited to, the separation and distribution agreement, the transition services agreement, the tax sharing agreement, and certain commercial agreements and the transfer documents in connection with the separation.

Indemnification

In addition, the separation and distribution agreement will provide for cross-indemnities principally designed to place financial responsibility for the obligations and liabilities of our business with us and financial responsibility for the obligations and liabilities of Harvard Bioscience’s business with Harvard Bioscience. Specifically, each party will indemnify, defend and hold harmless the other party, its affiliates and subsidiaries and its officers, directors, employees and agents for any losses arising out of or otherwise in connection with:

88


 
 

TABLE OF CONTENTS

the liabilities that each such party assumed or retained pursuant to the separation and distribution agreement (which, in the case of our company, would include the HART liabilities and, in the case of Harvard Bioscience, would include the excluded liabilities) and the other transaction agreements;
the operation of such party’s business (other than, in the case of Harvard Bioscience, our business);
any guarantee, indemnification obligation, surety bond or other credit support agreement, arrangement, commitment or understanding for the benefit of such party or its subsidiaries by the other party or any of its subsidiaries that survives following the separation date; and
any breach by such party of the separation and distribution agreement or the other transaction agreements.

Also, we will indemnify, defend and hold harmless Harvard Bioscience, its affiliates and subsidiaries and its officers, directors, employees and agents for any losses arising out of or otherwise in connection with any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated in the registration statement of which this prospectus is a part or in this prospectus or necessary to make the statements in such registration statement or this prospectus not misleading.

The separation and distribution agreement also specifies procedures with respect to claims subject to indemnification and related matters.

Access to Information

Under the separation and distribution agreement, following the separation, we and Harvard Bioscience are obligated to provide each other access to information as follows:

subject to applicable confidentiality obligations and other restrictions, we and Harvard Bioscience will give each other any information within each other’s possession that the requesting party reasonably needs to comply with requirements imposed on the requesting party by a governmental authority, for use in any proceeding or to satisfy audit, accounting or similar requirements, or to comply with its obligations under the separation and distribution agreement or any ancillary agreement;
we will maintain in effect at our own cost and expense adequate systems and controls to the extent necessary to enable Harvard Bioscience and its subsidiaries to satisfy their respective reporting, accounting, audit and other obligations, and we will provide to Harvard Bioscience in such form as Harvard Bioscience may request, at no charge to Harvard Bioscience, all financial and other data and information as Harvard Bioscience determines necessary or advisable in order to prepare its financial statements and reports or filings with any governmental authorities, including copies of all quarterly and annual financial information and other reports and documents we intend to file with the SEC prior to such filings (as well as final copies upon filing), and copies of our budgets and financial projections;
subject to certain exceptions we and Harvard Bioscience will use reasonable efforts to make available to each other, our past, present and future directors, officers, other employees and representatives to the extent reasonably required as witnesses in any legal, administrative or other proceedings in which the other party may become involved;
the company providing information, consultant or witness services under the separation and distribution agreement will be entitled to reimbursement from the other for reasonable expenses incurred in providing this assistance;
we will retain certain information owned by us or in our possession relating to our business in accordance with Harvard Bioscience’s record retention policy and, if we intend to destroy this information prior to the end of the retention period required by Harvard Bioscience’s retention policy, we must give Harvard Bioscience the opportunity to take possession of the information; and
we and Harvard Bioscience will hold in strict confidence all proprietary information concerning or belonging to the other party for a five year period after the separation, unless legally required to disclose such proprietary information.

89


 
 

TABLE OF CONTENTS

Insurance

The separation and distribution agreement provides for the allocation among the parties of rights and obligations under existing insurance policies with respect to occurrences prior to the separation and will set forth procedures for the administration of insured claims. In addition, the separation and distribution agreement will allocate between the parties the right to proceeds and the obligation to incur certain deductibles under certain insurance policies. The separation and distribution agreement will also provide that Harvard Bioscience will obtain, subject to the terms of the agreement, certain directors and officers insurance policies to apply against certain pre-separation claims, if any.

Expenses

We shall pay, or reimburse Harvard Bioscience to the extent it has paid such amounts, all third-party costs, fees and expenses relating to the offering, the underwriting discounts and commissions, all of the reimbursable expenses of the underwriters pursuant to the underwriting agreement and all of the costs of producing, printing, mailing and otherwise distributing the prospectus. All other third-party fees, costs and expenses paid or incurred in connection with our separation from Harvard Bioscience and the planned distribution will be paid by Harvard Bioscience. Except as otherwise set forth above or as provided in the separation and distribution agreement or other transaction agreements, all other costs and expenses will be borne by the party incurring such costs and expenses.

Termination

The separation and distribution agreement may be terminated and the distribution may be amended, modified or abandoned at any time prior to the separation date by Harvard Bioscience. Harvard Bioscience also has the right to terminate its obligation to complete the distribution if, at any time, Harvard Bioscience’s board of directors determines, in its sole discretion, that the distribution is not in the best interests of Harvard Bioscience or its stockholders. In the event of a termination of the separation and distribution agreement on or after the completion of this offering, only the provisions of the separation and distribution agreement that obligate the parties to pursue the distribution will terminate. The other provisions of the separation and distribution agreement and the other transaction agreements that Harvard Bioscience and we enter into will remain in full force and effect.

Tax Sharing Agreement

Allocation of Taxes

Prior to this offering, we and Harvard Bioscience will enter into a tax sharing agreement that will govern the parties’ respective rights, responsibilities and obligations with respect to tax liabilities and benefits, tax attributes, the preparation and filing of tax returns, the control of audits and other tax proceedings and other matters regarding taxes. In general, under the tax sharing agreement:

With respect to any periods (or portions thereof) ending at or prior to the distribution, Harvard Bioscience is responsible for any U.S. federal income taxes (including any interest or penalties thereon and any audit adjustment) and any U.S. state or local income taxes (including any interest or penalties thereon and any audit adjustment) reportable on a consolidated, combined or unitary return.
After the planned distribution of our common stock by Harvard Bioscience, Harvard Bioscience will be responsible for U.S. federal, state or local income taxes reportable on returns that include only Harvard Bioscience and its subsidiaries (excluding us and our subsidiaries), and we will be responsible for any U.S. federal, state or local income taxes reportable on returns that include only us and our subsidiaries.
Harvard Bioscience is responsible for any non-income taxes reportable on returns that include only Harvard Bioscience and its subsidiaries (excluding us and our subsidiaries), and after the planned distribution, we are responsible for any non-income taxes filed on returns that include only us and our subsidiaries.

90


 
 

TABLE OF CONTENTS

We are generally not entitled to receive payment from Harvard Bioscience in respect of any of our tax attributes or tax benefits or any reduction of taxes of Harvard Bioscience. Moreover, Harvard Bioscience is generally entitled to refunds of income taxes with respect to periods (or portions thereof) ending at or prior to the distribution.

If we realize any refund, credit or other reduction in otherwise required tax payments in any period (or portion thereof) beginning after the distribution as a result of an audit adjustment resulting in taxes for which Harvard Bioscience would otherwise be responsible, then, subject to certain exceptions, Harvard Bioscience will be entitled to such refund, credit or reduction. Further, if any taxes result to Harvard Bioscience as a result of a reduction in our tax attributes for a period (or portion thereof) ending at or prior to the distribution pursuant to an audit adjustment (relative to the amount of such tax attribute reflected on Harvard Bioscience’s tax return as originally filed), then, subject to certain exceptions, Harvard Bioscience will be responsible for paying the amount of any such taxes.

Our obligations under the tax sharing agreement are not limited in amount or subject to any cap. Further, even if we are not responsible for tax liabilities of Harvard Bioscience and its subsidiaries under the tax sharing agreement, we nonetheless could be liable under applicable tax law for such liabilities.

The tax sharing agreement also assigns responsibilities for administrative matters, such as the filing of returns, payment of taxes due, retention of records and conduct of audits, examinations or similar proceedings. In addition, the tax sharing agreement provides for cooperation and information sharing with respect to tax matters.

Harvard Bioscience is primarily responsible for preparing and filing any tax return with respect to the Harvard Bioscience affiliated group for U.S. federal income tax purposes and with respect to any consolidated, combined or unitary group for U.S. state or local income tax purposes that includes Harvard Bioscience or any of its subsidiaries. Under the tax sharing agreement, we generally will be responsible for preparing and filing any tax returns that include only us and our subsidiaries for tax periods beginning after the distribution.

Harvard Bioscience generally has exclusive authority to control tax contests related to any tax returns of the Harvard Bioscience affiliated group for U.S. federal income tax purposes and with respect to any consolidated, combined or unitary group for U.S. state or local income tax purposes that includes Harvard Bioscience or any of its subsidiaries. We generally have exclusive authority to control tax contests with respect to tax returns that include only us and our subsidiaries for tax periods beginning after the distribution.

Preservation of the Tax-free Status of the Distribution

Harvard Bioscience and we intend the contribution and distribution, taken together, to qualify as a reorganization pursuant to which no gain or loss is recognized by Harvard Bioscience or its stockholders for federal income tax purposes under Sections 355, 368(a)(1)(D) and related provisions of the Internal Revenue Code. Harvard Bioscience has applied for a private letter ruling from the Internal Revenue Service to such effect and intends to seek an opinion from its outside tax advisor to such effect. In connection with the ruling and the opinion, we made or will make, respectively, certain representations regarding our company and our business and Harvard Bioscience made or will make, respectively, certain representations regarding it and its business.

We have also agreed to certain restrictions that are intended to preserve the tax-free status of the contribution and the distribution. We may take certain actions otherwise prohibited by these covenants if Harvard Bioscience receives a private letter ruling from the IRS or if we obtain, and provide to Harvard Bioscience, an opinion from a U.S. tax counsel or accountant of recognized national standing, in either case, acceptable to Harvard Bioscience in its sole and absolute discretion to the effect that such action would not jeopardize the tax-free status of the contribution and the distribution. These covenants include restrictions on our:

issuance or sale of stock or other securities (including securities convertible into our stock but excluding certain compensatory arrangements);
sales of assets outside the ordinary course of business; and
entering into any other corporate transaction which would cause us to undergo a 50 percent or greater change in our stock ownership.

91


 
 

TABLE OF CONTENTS

We have generally agreed to indemnify Harvard Bioscience and its affiliates against any and all tax-related liabilities incurred by them relating to the contribution or the distribution to the extent caused by an acquisition of our stock or assets, or other actions of ours. This indemnification applies even if Harvard Bioscience has permitted us to take an action that would otherwise have been prohibited under the tax-related covenants as described above.

Transition Services Agreement

Prior to this offering, we and Harvard Bioscience will enter into a transition services agreement in connection with the separation pursuant to which, Harvard Bioscience will provide us, on a transitional basis, certain administrative, human resources, treasury and support services and other assistance, consistent with the services provided by Harvard Bioscience before the separation. Pursuant to the transition services agreement, Harvard Bioscience will provide certain support services to us, including, among others, accounting, payroll, human resources, information systems and various other corporate services, as well as procurement, sourcing and manufacturing support. The charges for the transition services generally are intended to allow Harvard Bioscience to fully recover the costs directly associated with providing the services, plus all out-of-pocket costs and expenses, generally without profit. The charges of each of the transition services generally will be based on either a pre-determined flat fee or an allocation of the cost incurred by Harvard Bioscience providing the service, including certain fees and expenses of third-party service providers. We will be provided with reasonable information that supports the charges for such transition service by Harvard Bioscience.

We have been preparing for the transition of the services to be provided by Harvard Bioscience under the transition services agreement from Harvard Bioscience, or third-party providers on behalf of Harvard Bioscience, to us. We anticipate that we will be in a position to complete the transition of those services on or before one year following the separation date.

The services provided under the transition services agreement will terminate at various times specified in the agreement (generally ranging from six months to one year after the completion of the separation). We may terminate certain specified services by giving prior written notice to the provider of such services and paying any applicable termination charge.

Subject to certain exceptions, the liabilities of Harvard Bioscience under the transition services agreement will generally be limited to the aggregate charges (excluding any third-party costs and expenses included in such charges) actually paid to Harvard Bioscience pursuant to the transition services agreement. The transition services agreement also provides that Harvard Bioscience will not be liable to us of such service for any special, indirect, incidental or consequential damages.

Sublicense Agreement

We have entered into a sublicense agreement with Harvard Bioscience pursuant to which Harvard Bioscience has granted us a perpetual, worldwide, royalty-free, exclusive, except as to Harvard Bioscience and its subsidiaries, license to use the mark “Harvard Apparatus” in the name Harvard Apparatus Regenerative Technology. The mark “Harvard Apparatus” is used under a license agreement between Harvard Bioscience and Harvard University, and we have agreed to be bound by such license agreement in accordance with our sublicense. We currently have no affiliation with Harvard University.

Sublease

We have entered into a Sublease with Harvard Bioscience pursuant to which we sublease approximately 10,000 square feet of mixed use space of the facility located at 84 October Hill Road, Holliston, Massachusetts. The Sublease has an initial term of 18 months expiring ____________, but such term will automatically extend for additional successive one year periods unless either party provides 180 days notice that it does not wish to extend the agreement. In addition, the term of the Sublease will not extend beyond the term of Harvard Bioscience’s primary lease of the facility which currently is set to expire May 31, 2017.

92


 
 

TABLE OF CONTENTS

PRINCIPAL STOCKHOLDERS

The following table sets forth information with respect to the beneficial ownership of our common stock, as of December 31, 2012, on a pre-offering basis and as adjusted to reflect the sale of our common stock offered by this prospectus, by:

each of our directors;
each of our named executive officers;
all of our directors and executive officers as a group; and
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our common stock.

Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Shares of common stock that may be acquired by an individual or group within 60 days of December 31, 2012, pursuant to the exercise of options or warrants, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Percentage of ownership before this offering is based on an aggregate of       shares of common stock outstanding on December 31, 2012. Except as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders. The address for each director and executive officer listed is: c/o Harvard Apparatus Regenerative Technology, Inc., 84 October Hill Road, Holliston, MA 01746.

       
  Shares of Common Stock
Beneficially Owned
  Percentage of Outstanding Shares Beneficially Owned
Beneficial Owner   Before
Offering
  After
Offering
  Before
Offering
  After
Offering
Harvard Bioscience, Inc.
84 October Hill Road
Holliston, MA 01746
                (1)       100 %         % (1)  
David Green           (1)       *%       *% (1)  
Chane Graziano           (1)       *%       *% (1)  
John F. Kennedy           (1)       *%       *% (1)  
Thomas Robinson           (1)       *%       *% (1)  
Thomas McNaughton           (1)       *%       *% (1)  
All directors and executive officers as a group (5 persons)           (1)       *%       *% (1)  

(1) Assuming the underwriters do not exercise their option to acquire additional shares, as described in the section “Underwriting” below. If they do exercise in full their option to acquire additional shares, Harvard Bioscience will own approximately    percent of our outstanding shares of common stock after this offering.
* represents 0%

In addition to the shares of common stock reflected in the table above, we anticipate that at the time of completion of this offering, we will grant (i) aggregate of      stock options to acquire our common stock to our named executive officers and certain other employees as described in “Director and Executive Compensation — IPO Grants; and (ii) aggregate of      stock options to acquire our common stock to our non-employee directors as described in “Director and Executive Compensation — Board of Directors’ Compensation.”

In the event that Harvard Bioscience completes its planned distribution of our common stock, we anticipate that we will issue stock options to acquire our common stock and restricted stock units pertaining to the

93


 
 

TABLE OF CONTENTS

adjustment and conversion of outstanding Harvard Bioscience equity awards upon the effectiveness of the planned distribution as described in “Director and Executive Compensation — Treatment of Outstanding Harvard Bioscience Equity Awards.” The total value of the adjustments will depend on other estimates, including those involved in valuing options. As a result, the number of options for our common stock and the quantity of our restricted stock units to be issued at the time of the distribution is not known at this time. Subject to the above qualifications, assuming that the market price of Harvard Bioscience’s common stock was $      per share immediately prior to the distribution and $      per share immediately after the distribution, and the market price of our common stock was $      per share immediately after the distribution, we expect that we would issue approximately      options to acquire approximately      shares of our common stock and approximately restricted stock units as a part of the required adjustment described above.

94


 
 

TABLE OF CONTENTS

DESCRIPTION OF SECURITIES

We have provided below a summary description of our capital stock as it will be in effect upon completion of this offering. This description is not complete. You should read the full text of our amended and restated certificate of incorporation and amended and restated by-laws, which will be filed as exhibits to the registration statement of which this prospectus is a part, as well as the provisions of applicable Delaware law.

Distributions of Securities

Except for our issuance of the common stock upon formation to Harvard Bioscience, our sole stockholder, in the past three years, we have not sold any securities, including sales of reacquired securities, new issues, securities issued in exchange for property, services, or other securities, and new securities resulting from the modification of outstanding securities, which were not registered under the Securities Act of 1933, as amended.

Authorized Capital Stock

Upon completion of this offering, our authorized capital stock will consist of up to      million shares of common stock, par value $0.01 per share, and      shares of preferred stock, par value $0.01 per share.

Common Stock

Shares Outstanding.   Upon completion of this offering, we expect that approximately      million shares of our common stock will be issued and outstanding (      shares if the underwriters exercise their over-allotment option in full).

Dividends.   Subject to prior dividend rights of the holders of any preferred stock, holders of shares of our common stock are entitled to receive dividends when, as and if declared by our board of directors out of funds legally available for that purpose.

Voting Rights.   Each outstanding share of common stock will be entitled to one vote per share on all matters submitted to a vote of the stockholders. The holders of our common stock will not be entitled to cumulative voting of their shares in elections of directors.

Other Rights.   In the event of any liquidation, dissolution or winding up of our company, after the satisfaction in full of the liquidation preferences of holders of any preferred stock, holders of shares of our common stock are entitled to ratable distribution of the remaining assets available for distribution to stockholders. The shares of our common stock are not subject to redemption by operation of a sinking fund or otherwise. Holders of shares of our common stock are not currently entitled to pre-emptive rights.

Fully Paid.   The issued and outstanding shares of our common stock are fully paid and non-assessable. Any additional shares of common stock that we may issue in the future will also be fully paid and non-assessable.

Undesignated Preferred Stock

Upon completion of this offering, we expect that we will have no outstanding shares of preferred stock. Our board of directors may, from time to time, authorize the issuance of one or more classes or series of preferred stock without stockholder approval. We have no current intention to issue any shares of preferred stock.

Our amended and restated certificate of incorporation permits us to issue up to      shares of preferred stock from time to time. Subject to the provisions of our amended and restated certificate of incorporation and limitations prescribed by law, our board of directors is authorized to adopt resolutions to issue shares, establish the number of shares, change the number of shares constituting any series, and provide or change the voting powers, designations, preferences and relative rights, qualifications, limitations, or restrictions on shares of our preferred stock, including dividend rights, terms of redemption, conversion rights, and liquidation preferences, in each case without any action or vote by our stockholders. Any shares of preferred stock that we redeem, purchase, or acquire may be reissued except as otherwise provided by law.

2013 Equity Incentive Plan

On            , 2013, our sole stockholder and board of directors approved our 2013 Equity Incentive Plan pursuant to which our board of directors can grant stock options to employees, directors and consultants. The 2013 Equity Incentive Plan will also permit the company to make grants of incentive stock options,

95


 
 

TABLE OF CONTENTS

non-qualified stock options, stock appreciation rights, deferred stock awards, restricted stock awards, unrestricted stock awards, performance shares and dividend equivalent rights. We currently have reserved shares of common stock for the issuance of awards under the 2013 Equity Incentive Plan. Refer to “Management — Employment Benefit Plans — 2013 Equity Incentive Plan” for a more comprehensive discussion of our 2013 Equity Incentive Plan.

Employee Stock Purchase Plan

On            , 2013, our sole stockholder and board of directors approved a stock purchase plan. Under this plan, participating employees can authorize us to withhold a portion of their base pay during consecutive six-month payment periods for the purchase of shares of our common stock. At the conclusion of the period, participating employees can purchase shares of the company’s common stock at 85% of the lower of the fair market value of our common stock at the beginning or end of the period. Shares are issued under the plan for the six-month periods ending June 30 and December 31. Under this plan,       shares of common stock are authorized for issuance. Refer to “Management — Employment Benefit Plans — Employee Stock Purchase Plan” for a more comprehensive discussion of our Employee Stock Purchase Plan.

Rights Plan

We expect our board of directors will adopt a rights agreement on or prior to the distribution date. Pursuant to the rights agreement, one preferred stock purchase right will be issued for each outstanding share of our common stock. Each right issued will be subject to the terms of the rights agreement.

Our board of directors believes that the rights agreement will protect our stockholders from coercive or otherwise unfair takeover tactics. In general terms, our rights agreement works by imposing a significant penalty upon any person or group that acquires 20% or more of our outstanding common stock, without the approval of our board of directors.

Anti-takeover Effects of our Rights Plan, Our Certificate of Incorporation and By-laws and Delaware Law

Our rights plan and some provisions of our amended and restated certificate of incorporation and amended and restated by-laws and of Delaware law could make the following more difficult:

acquisition of us by means of a tender offer;
acquisition of us by means of a proxy contest or otherwise; or
removal of our incumbent officers and directors.

These provisions, which are summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection give us the potential ability to negotiate with the proponent of an unsolicited proposal to acquire or restructure us and outweigh the disadvantages of discouraging those proposals because negotiation of the proposals could result in an improvement of their terms.

Classified Board

Our amended and restated certificate of incorporation and amended and restated by-laws provide that our board of directors is divided into three classes. The term of the first class expires at our 2014 annual meeting of our stockholders, the term of our second class of directors expires at our 2015 annual meeting of our stockholders and the term of our third class of directors expires at our 2016 annual meeting of our stockholders. At each of our annual meetings of stockholders, the successors of the class of directors whose term expires at that meeting of stockholders will be elected for a three-year term, one class being elected each year by our stockholders.

Removal of Directors

Our amended and restated certificate of incorporation provides that a director may only be removed from office for cause by the affirmative vote of holders of shares representing at least a majority of the votes entitled to be cast on such matter by the then-outstanding shares of all classes and series of our capital stock,

96


 
 

TABLE OF CONTENTS

provided that after such time that Harvard Bioscience ceases to beneficially own at least a majority of the voting power of all classes of our capital stock, any removal of directors will require the vote of the holders of at least 75% of the outstanding shares entitled to be cast on the election of directors by the then-outstanding shares of all classes and series of capital stock, voting together as a single class. This system of electing and removing directors may discourage a third party from making a tender offer or otherwise attempting to obtain control of us because it generally makes it more difficult for stockholders to replace a majority of the directors.

Size of Board and Vacancies

Our amended and restated certificate of incorporation and amended and restated by-laws provide that our board of directors will fix the exact number of directors to comprise our board of directors. Subject to any rights that holders of any series of our undesignated preferred stock (as described below) may have to elect directors and to fill vacancies on our board, newly created directorships resulting from any increase in our authorized number of directors will be filled by a majority of our board of directors then in office and any vacancies in our board of directors resulting from death, resignation, retirement, disqualification, removal from office or other cause will be filled generally by the majority vote of our remaining directors in office, even if less than a quorum is present or by a sole remaining director.

Elimination of Stockholder Action by Written Consent

Our amended and restated certificate of incorporation and amended and restated by-laws expressly eliminate the right of our stockholders to act by written consent and stockholder action must take place at the annual or special meeting of our stockholders; provided, however, for so long as Harvard Bioscience beneficially owns shares of our common stock representing at least a majority of the votes that would be entitled to be cast on such action, any action required or permitted to be taken by the stockholders may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing, setting forth the action to be taken, are signed by the holders of outstanding stock having at least the minimum number of votes necessary to authorize such action.

Stockholder Meetings

Under our amended and restated certificate of incorporation and amended and restated by-laws, only our board of directors, pursuant to a resolution adopted by a majority of our directors, may call special meetings of our stockholders.

Requirements for Advance Notification of Stockholder Nominations and Proposals

Our amended and restated by-laws have advance notice procedures with respect to stockholder proposals and nominations of candidates for election as directors other than nominations made by or at the direction of our board of directors or a committee of our board of directors. The business to be conducted at an annual meeting will be limited to business properly brought before the annual meeting by or at the direction of our board of directors or a duly authorized committee thereof or by a stockholder of record who has given timely written notice to our secretary of that stockholder’s intention to bring such business before such meeting in accordance with the amended and restated by-laws.

Delaware Anti-takeover Law

Upon the distribution, we will be governed by Section 203 of the General Corporation Law of the State of Delaware, or DGCL. Section 203, subject to certain exceptions, prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the time that such stockholder became an interested stockholder, unless:

prior to such time, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; or

upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85.0% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or

97


 
 

TABLE OF CONTENTS

at or subsequent to such time, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, by the affirmative vote of at least  662/3% of the outstanding voting stock that is not owned by the interested stockholder. The stockholders cannot authorize the business combination by written consent.

The application of Section 203 may limit the ability of stockholders to approve a transaction that they may deem to be in their best interests.

In general, Section 203 defines “business combination” to include:

any merger or consolidation involving the corporation and the interested stockholder; or
any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10.0% or more of the assets of the corporation to or with the interested stockholder; or
subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any of its stock to the interested stockholder; or
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an “interested stockholder” as any person that is:

the owner of 15% or more of the outstanding voting stock of the corporation; or
an affiliate or associate of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the relevant date; or
the affiliates and associates of the above.

Under specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation’s certificate of incorporation or by-laws, elect not to be governed by this section, effective twelve months after adoption.

Our amended and restated certificate of incorporation and by-laws do not exclude us from the restrictions imposed under Section 203. We anticipate that the provisions of Section 203 may encourage companies interested in acquiring us to negotiate in advance with our board of directors since the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder.

Supermajority Voting

Our amended and restated certificate of incorporation provides that amendments which require the vote of our stockholders and which relate to provisions in the amended and restated certificate of incorporation relating to the general powers of the board of directors, the number, classes and tenure of directors, filling vacancies on the board, removal of directors, limitation of liability of directors, special meetings of stockholders, stockholder action by written consent, the amendment provision of our amended and restated by-laws and the supermajority amendment provision of the amended and restated certificate of incorporation shall require the affirmative vote of the holders of at least 75% of the outstanding shares of each class of our stock entitled to vote on such amendment as a class.

Our amended and restated certificate of incorporation and amended and restated by-laws provide that amendments to the amended and restated by-laws may be made either (i) by a vote of at least a majority of our entire board of directors or (ii) by a vote of the holders of at least a majority of the combined voting power of the outstanding shares of all classes and series of our capital stock entitled to vote on such amendment as a class, until such time as Harvard Bioscience ceases to beneficially own at least a majority of

98


 
 

TABLE OF CONTENTS

the voting power of all classes of our capital stock, after which any amendment will require the vote of the holders of at least 75% of the outstanding shares of each class of our stock entitled to vote on such amendment as a class.

No Cumulative Voting

Our amended and restated certificate of incorporation and amended and restated by-laws do not provide for cumulative voting in the election of directors.

Undesignated Preferred Stock

The authorization in our amended and restated certificate of incorporation of undesignated preferred stock makes it possible for our board of directors to issue our preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of us. The provisions in our amended and restated certificate of incorporation authorizing such preferred stock may have the effect of deferring hostile takeovers or delaying changes of control of our management.

Restrictions on Payment of Dividends

We are incorporated in Delaware and are governed by Delaware law. Delaware law allows a corporation to pay dividends only out of surplus, as determined under Delaware law.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Registrar & Transfer Company.

NASDAQ Capital Market Listing

We have filed an application to list our shares of common stock on the NASDAQ Capital Market. We expect that our shares will trade under the ticker symbol “HART.”

Limitation on Liability of Directors and Indemnification of Directors and Officers

Section 145 of the DGCL provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement in connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, in which such person is made a party by reason of the fact that the person is or was a director, officer, employee or agent of the corporation (other than an action by or in the right of the corporation — a “derivative action”), if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe such person’s conduct was unlawful. A similar standard is applicable in the case of derivative actions, except that indemnification only extends to expenses (including attorneys’ fees) incurred in connection with the defense or settlement of such action, and the statute requires court approval before there can be any indemnification where the person seeking indemnification has been found liable to the corporation. The statute provides that it is not exclusive of other indemnification that may be granted by a corporation’s by-laws, disinterested director vote, stockholder vote, agreement or otherwise.

Our amended and restated certificate of incorporation provides that no director shall be liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except to the extent such exemption from liability or limitation on liability is not permitted under the DGCL, as now in effect or as amended. Currently, Section 102(b)(7) of the DGCL requires that liability be imposed for the following:

any breach of the director’s duty of loyalty to our company or our stockholders;
any act or omission not in good faith or which involved intentional misconduct or a knowing violation of law;
unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; and
any transaction from which the director derived an improper personal benefit.

99


 
 

TABLE OF CONTENTS

Our amended and restated certificate of incorporation and amended and restated by-laws provide that, to the fullest extent authorized or permitted by the DGCL, as now in effect or as amended, we will indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding by reason of the fact that such person, or a person of whom he or she is the legal representative, is or was our director or officer, or by reason of the fact that our director or officer is or was serving, at our request, as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans maintained or sponsored by us. We will indemnify such persons against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with such action if such person acted in good faith and in a manner reasonably believed to be in our best interests and, with respect to any criminal proceeding, had no reason to believe such person’s conduct was unlawful. A similar standard is applicable in the case of derivative actions, except that indemnification only extends to expenses (including attorneys’ fees) incurred in connection with the defense or settlement of such actions, and court approval is required before there can be any indemnification where the person seeking indemnification has been found liable to us. Any amendment of this provision will not reduce our indemnification obligations relating to actions taken before an amendment.

We intend to obtain policies that insure our directors and officers and those of our subsidiaries against certain liabilities they may incur in their capacity as directors and officers. Under these policies, the insurer, on our behalf, may also pay amounts for which we have granted indemnification to the directors or officers.

100


 
 

TABLE OF CONTENTS

SHARES AVAILABLE FOR FUTURE SALE

Immediately prior to this offering, there was no public market for our common stock. Sales of substantial amounts of our common stock in the public market could adversely affect prevailing market prices of our common stock. Some shares of our common stock will not be available for sale for a certain period of time after this offering because they are subject to contractual and legal restrictions on resale, some of which are described below. Sales of substantial amounts of common stock in the public market after these restrictions lapse, or the perception that these sales could occur, could adversely affect the prevailing market price and our ability to raise equity capital in the future.

Sales of Restricted Securities

After this offering,      shares of our common stock will be outstanding. Of these shares, all of the shares sold in this offering will be freely tradeable without restriction under the Securities Act, unless purchased by our “affiliates,” as that term is defined in Rule 144 under the Securities Act. The remaining      shares of our common stock that will be outstanding after this offering are “restricted securities” within the meaning of Rule 144 under the Securities Act. Restricted securities may be sold in the public market only if they are registered under the Securities Act or are sold pursuant to an exemption from registration under Rule 144 or Rule 701 under the Securities Act, which are summarized below. Subject to the lock-up agreements described below, shares held by our affiliates that are not restricted securities or that have been owned for more than one year may be sold subject to compliance with Rule 144 of the Securities Act without regard to the prescribed one-year holding period under Rule 144.

Lock-up Agreements

Harvard Bioscience, all of our directors and executive officers have signed lock-up agreements under which they have agreed not to sell, transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock without the prior written consent of Summer Street Research Partners, for a period of 180 days (120 days for the common stock owned by Harvard Bioscience), subject to possible extension under certain circumstances, after the date of this prospectus. These agreements are described below under “Underwriting — No Sales of Similar Securities.”

Rule 144

In general, under Rule 144, beginning 90 days after the date of this prospectus, a person who is not our affiliate and has not been our affiliate at any time during the preceding three months will be entitled to sell any shares of our common stock that such person has beneficially owned for at least six months, including the holding period of any prior owner other than one of our affiliates, without regard to volume limitations. Sales of our common stock by any such person would be subject to the availability of current public information about us if the shares to be sold were beneficially owned by such person for less than one year.

In addition, under Rule 144, a person may sell shares of our common stock acquired from us immediately upon the closing of this offering, without regard to volume limitations or the availability of public information about us, if:

the person is not our affiliate and has not been our affiliate at any time during the preceding three months; and
the person has beneficially owned the shares to be sold for at least one year, including the holding period of any prior owner other than one of our affiliates.

Approximately      shares of our common stock that are not subject to the lock-up agreements described above will be eligible for sale under Rule 144 immediately upon the closing of this offering.

Beginning 90 days after the date of this prospectus, and subject to the lock up agreements described above, our affiliates who have beneficially owned shares of our common stock for at least six months, including the holding period of any prior owner other than one of our affiliates, would be entitled to sell within any three-month period a number of shares that does not exceed the greater of:

101


 
 

TABLE OF CONTENTS

1% of the number of shares of our common stock then outstanding, which will equal approximately      shares immediately after this offering, assuming an initial public offering price of $      per share (which is the midpoint of the price range set forth on the cover page of this prospectus); and
the average weekly trading volume in our common stock on the NASDAQ Capital Market during the four calendar weeks preceding the date of filing of a Notice of Proposed Sale of Securities Pursuant to Rule 144 with respect to the sale.

Sales under Rule 144 by our affiliates are also subject to manner of sale provisions and notice requirements and to the availability of current public information about us.

Rule 701

Any of our employees, officers or directors who acquired shares under a written compensatory plan or contract may be entitled to sell them in reliance on Rule 701. Rule 701 permits affiliates to sell their Rule 701 shares under Rule 144 without complying with the holding period requirements of Rule 144. Rule 701 further provides that non-affiliates may sell these shares in reliance on Rule 144 without complying with the holding period, public information, volume limitation or notice provisions of Rule 144. All holders of Rule 701 shares are required to wait until 90 days after the date of this prospectus before selling those shares. However, all shares issued under Rule 701 are subject to lock-up agreements and will only become eligible for sale when the 180-day lock-up agreements expire.

Equity Incentive Plans

Prior to completion of this offering, we will have two employee share-based incentive plans, our 2013 Equity Incentive Plan and Employee Stock Purchase Plan. These plans will be adopted to enable the company to better align our compensation programs with those typical of companies with publicly traded securities. Following this offering, we intend to file one or more registration statements on Form S-8 under the Securities Act to register all of the shares of common stock issuable upon exercise of outstanding options as well as all shares of our common stock reserved for future issuance under our equity plans. Shares of our common stock issued under a registration statement on Form S-8 will be available for sale in the public market, subject to the Rule 144 provisions applicable to affiliates, and subject to any vesting restrictions and lock-up agreements applicable to these shares.

Distribution

We expect Harvard Bioscience to distribute all of our common stock that it owns to Harvard Bioscience’s stockholders on a pro rata basis on or after the date that is four months after the offering date.

102


 
 

TABLE OF CONTENTS

MATERIAL U.S. TAX CONSIDERATIONS FOR NON-U.S. HOLDERS OF COMMON STOCK

The following is a general discussion of material U.S. federal income and estate tax considerations relating to ownership and disposition of our common stock by a non-U.S. holder. For purposes of this discussion, the term “non-U.S. holder” means a beneficial owner of our common stock that is not, for U.S. federal income tax purposes:

an individual who is a citizen or resident of the U.S.;
a corporation, or other entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the U.S. or of any political subdivision of the U.S.;
an estate the income of which is subject to U.S. federal income taxation regardless of its source; or
a trust, if a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to control all substantial decisions of the trust or if the trust has a valid election to be treated as a U.S. person under applicable U.S. Treasury Regulations.

An individual may be treated as a resident instead of a nonresident of the U.S. in any calendar year for U.S. federal income tax purposes if the individual was present in the U.S. for at least 31 days in that calendar year and for an aggregate of at least 183 days during the three-year period ending with the current calendar year. For purposes of this calculation, all of the days present in the current year, one-third of the days present in the immediately preceding year, and one-sixth of the days present in the second preceding year are counted. Residents of the U.S. are taxed for U.S. federal income tax purposes as if they were U.S. citizens.

This discussion is based on current provisions of the Code, existing and proposed U.S. Treasury Regulations promulgated thereunder, current administrative rulings, and judicial decisions, all publicly available and as in effect as of the date of this prospectus and all of which are subject to change or to differing interpretation, possibly with retroactive effect. Any change or differing interpretation could alter the tax consequences to non-U.S. holders described in this prospectus. In addition, the IRS could challenge one or more of the tax consequences described in this prospectus and we have not obtained nor do we intend to obtain an opinion of counsel with respect to the U.S. federal income or estate tax consequences to a non-U.S. holder of acquiring, holding, and disposing of our common stock.

This discussion addresses only non-U.S. holders that hold shares of our common stock as a capital asset (generally, property held for investment). This discussion does not address all aspects of U.S. federal income and estate taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder’s individual circumstances nor does it address any aspects of U.S. state, local, or non-U.S. taxes. This discussion also does not consider any specific facts or circumstances that may apply to a non-U.S. holder and does not address the special tax rules applicable to particular non-U.S. holders, such as:

insurance companies;
tax-exempt organizations;
financial institutions;
brokers or dealers in securities;
regulated investment companies;
pension plans;
controlled foreign corporations;
passive foreign investment companies;
owners that hold our common stock as part of a straddle, hedge, conversion transaction, synthetic security, or other integrated investment; and
certain U.S. expatriates.

103


 
 

TABLE OF CONTENTS

In addition, this discussion does not address the tax treatment of partnerships or persons who hold their common stock through partnerships or other entities that are pass-through entities for U.S. federal income tax purposes. A partner in a partnership or other pass-through entity that will hold our common stock should consult his, her, or its own tax advisor regarding the tax consequences of the purchase, ownership, and disposition of our common stock through a partnership or other pass-through entity, as applicable.

Non-U.S. holders may be subject to different tax treatment than U.S. citizens and residents.

Prospective investors should consult their own tax advisors regarding the U.S. federal, state, local, and non-U.S. income and other tax considerations of acquiring, holding, and disposing of our common stock.

Dividends

If we pay distributions on our common stock, those distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such holder’s tax basis in the common stock. Any remaining excess will be treated as capital gain, subject to the tax treatment described below under the heading “— Gain on Disposition of Common Stock.”

Dividends paid to a non-U.S. holder generally will be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the U.S. and such holder’s country of residence. If we determine, at a time reasonably close to the date of payment of a distribution on our common stock, that the distribution will not constitute a dividend because we do not anticipate having current or accumulated earnings and profits, we intend not to withhold any U.S. federal income tax on the distribution as permitted by U.S. Treasury Regulations.

Dividends that are treated as effectively connected with a trade or business conducted by a non-U.S. holder within the U.S. and, if an applicable income tax treaty so provides, that are attributable to a permanent establishment or a fixed base maintained by the non-U.S. holder within the U.S. are generally exempt from the 30% withholding tax if the non-U.S. holder satisfies applicable certification and disclosure requirements. However, such U.S. effectively connected income is taxed on a net income basis at the same graduated U.S. federal income tax rates applicable to U.S. persons (as defined in the Code). Any U.S. effectively connected income received by a non-U.S. holder that is a corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the U.S. and such holder’s country of residence.

A non-U.S. holder of our common stock who claims the benefit of an applicable income tax treaty between the U.S. and such holder’s country of residence generally will be required to provide a properly executed IRS Form W-8BEN (or successor form) and satisfy applicable certification and other requirements. Non-U.S. holders are urged to consult their own tax advisors regarding their entitlement to benefits under a relevant income tax treaty.

A non-U.S. holder that is eligible for a reduced rate of U.S. withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim with the IRS.

Gain on Disposition of Common Stock

A non-U.S. holder generally will not be subject to U.S. federal income tax on gain recognized on a disposition of our common stock unless:

the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business in the U.S. and, if an applicable income tax treaty so provides, the gain is attributable to a permanent establishment or fixed base maintained by the non-U.S. holder in the U.S.; in these cases, the non-U.S. holder will be taxed on a net income basis at the regular graduated rates and in the manner applicable to U.S. persons, and if the non-U.S. holder is a foreign corporation, an additional branch profits tax at a 30% rate, or such lower rate as may be specified by an applicable income tax treaty, may also apply;

104


 
 

TABLE OF CONTENTS

the non-U.S. holder is a nonresident alien present in the U.S. for 183 days or more in the taxable year of the disposition and certain other requirements are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty) on the net gain derived from the disposition, which may be offset by U.S.-source capital losses of the non-U.S. holder, if any; or
we are, or have been at any time during the five-year period preceding such disposition (or the non-U.S. holder’s holding period, if shorter), a “U.S. real property holding corporation,” unless our common stock is regularly traded on an established securities market and the non-U.S. holder held no more than 5% of our outstanding common stock, directly or indirectly, during the shorter of the five year period ending on the date of the disposition or the period that the non-U.S. holder held our common stock. Generally, a corporation is a “U.S. real property holding corporation” if the fair market value of its “U.S. real property interests” equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its other assets used or held for use in a trade or business. Although there can be no assurance, we believe that we are not currently, and we do not anticipate becoming, a “U.S. real property holding corporation” for U.S. federal income tax purposes. No assurance can be provided that our common stock will be regularly traded on an established securities market for purposes of the rule described above.

Information Reporting and Backup Withholding

We must report annually to the IRS and to each non-U.S. holder the gross amount of the distributions on our common stock paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. holders may have to comply with specific certification procedures to establish that the holder is not a U.S. person (as defined in the Code) in order to avoid backup withholding at the applicable rate, currently 28%, with respect to dividends on our common stock. Generally, a non-U.S. holder will comply with such procedures if it provides a properly executed IRS Form W-8BEN (or other applicable Form W-8) or otherwise meets documentary evidence requirements for establishing that it is a non-U.S. holder, or otherwise establishes an exemption. Dividends paid to non-U.S. holders subject to withholding of U.S. federal income tax, as described above under the heading “— Dividends,” will generally be exempt from U.S. backup withholding.

Information reporting and backup withholding generally will apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outside the U.S. through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Non-U.S. holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to them.

Copies of information returns may be made available to the tax authorities of the country in which the non-U.S. holder resides or is incorporated under the provisions of a specific treaty or agreement.

Backup withholding is not an additional tax. Rather, any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder can be refunded or credited against the non-U.S. holder’s U.S. federal income tax liability, if any, provided that an appropriate claim is timely filed with the IRS.

Legislation Relating to Foreign Accounts

The Foreign Account Tax Compliance Act, or FATCA, was enacted in March 2010. Generally, FATCA imposes a 30% withholding tax on dividends on, and gross proceeds from the sale or other disposition of, our common stock if paid to a foreign entity unless (i) if the foreign entity is a “foreign financial institution,” the foreign entity undertakes certain due diligence, reporting, withholding, and certification obligations, (ii) if the foreign entity is not a “foreign financial institution,” the foreign entity identifies certain of its U.S. investors, or (iii) the foreign entity is otherwise excepted under FATCA.

105


 
 

TABLE OF CONTENTS

Although this legislation is effective with respect to amounts paid after December 31, 2012, under proposed regulations issued by the U.S. Department of the Treasury on February 8, 2012, withholding under FATCA will only apply (1) to payments of dividends on our common stock made after December 31, 2013 and (2) to payments of gross proceeds from a sale or other disposition of our common stock made after December 31, 2014. These proposed regulations are not final and will not be effective until they have been issued in final form. There can be no assurance as to when the final regulations will be issued or whether the final regulations will be substantially different from the proposed regulations. If withholding under FATCA is required on any payment related to our common stock, investors not otherwise subject to withholding (or that otherwise would be entitled to a reduced rate of withholding) on such payment may be required to seek a refund or credit from the IRS. Non-U.S. holders should consult their own tax advisors regarding the possible implications of FATCA on their investment in our common stock.

Federal Estate Tax

Common stock owned or treated as owned by an individual who is a non-U.S. holder (as specially defined for U.S. federal estate tax purposes) at the time of death will be included in the individual’s gross estate for U.S. federal estate tax purposes and, therefore, may be subject to U.S. federal estate tax, unless an applicable estate tax or other treaty provides otherwise.

The preceding discussion of material U.S. federal tax considerations is for general information only. It is not tax advice. Prospective investors should consult their own tax advisors regarding the particular U.S. federal, state, local, and non-U.S. tax consequences of purchasing, holding, and disposing of our common stock, including the consequences of any proposed changes in applicable laws.

106


 
 

TABLE OF CONTENTS

UNDERWRITING

Summer Street Research Partners is acting as representative of each of the underwriters named below. Subject to the terms and conditions set forth in an underwriting agreement among us and the underwriters, we have agreed to sell to the underwriters, and each underwriter has severally agreed to purchase from us, the number of shares of common stock set forth opposite its name below.

 
Underwriter   Number
of Shares
Summer Street Research Partners           
Total           

Subject to the terms and conditions set forth in the underwriting agreement, the underwriters have agreed, severally and not jointly, to purchase all of the shares sold under the underwriting agreement if any of these shares are purchased. If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the nondefaulting underwriters may be increased or the underwriting agreement may be terminated.

We have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to make in respect of those liabilities.

The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel, including the validity of the shares, and other conditions contained in the underwriting agreement, such as the receipt by the underwriters of officer’s certificates and legal opinions. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

Commissions and Discounts

The underwriters propose initially to offer the shares to the public at the public offering price set forth on the cover page of this prospectus and to dealers at that price less a concession not in excess of $      per share. After the initial offering of our shares, the public offering price, concession or any other term of the offering may be changed by the representative.

The following table shows the initial public offering price, underwriting discount and proceeds before expenses to us. The information assumes either no exercise or full exercise by the underwriters of their option to purchase additional shares.

     
  Per Share   Without Option   With Option
Initial public offering price   $     $     $  
Underwriting discount   $     $     $  
Proceeds, before expenses, to us   $     $     $  

The expenses of the offering, not including the underwriting discount, are estimated at $      and are payable by us.

Over-Allotment Option

We have granted an option to the underwriters, exercisable for 30 days after the date of this prospectus, to purchase up to      additional shares at the public offering price, less the underwriting discount, solely to cover shares of common stock sold by the underwriters in excess of the total number of shares set forth in the above table. If the underwriters exercise this option, each will be obligated, subject to conditions contained in the underwriting agreement, to purchase a number of additional shares proportionate to that underwriter’s initial amount reflected in the above table. If any of these additional shares are purchased, the underwriters will offer the additional shares on the same terms as those on which the shares are being offered.

107


 
 

TABLE OF CONTENTS

NASDAQ Capital Market Listing

We expect the shares to be approved for listing on the NASDAQ Capital Market, subject to notice of issuance, under the symbol “HART.” In order to meet the requirements for listing on that exchange, the underwriters have undertaken to sell a minimum number of shares to a minimum number of beneficial owners as required by that exchange.

Initial Public Offering Price

Prior to this offering, there has been no public market for our common stock. The initial public offering price will be determined through negotiations between us and the representative. In addition to prevailing market conditions, the factors to be considered in determining the initial public offering price are

the valuation multiples of publicly traded companies that the representative believes to be comparable to us,
our financial information,
the history of, and the prospects for, our company and the industry in which we compete,
an assessment of our management, its past and present operations, and the prospects for, and timing of, our future revenues,
the present state of our development, and
the above factors in relation to market values and various valuation measures of other companies engaged in activities similar to ours.

An active trading market for the shares may not develop. It is also possible that after the offering the shares will not trade in the public market at or above the initial public offering price.

No Sales of Similar Securities

We, our executive officers and directors have agreed not to sell or transfer any common stock or securities convertible into, exchangeable for, exercisable for, or repayable with common stock, for 180 days after the date of this prospectus without first obtaining the written consent of Summer Street Research Partners. Our sole stockholder, Harvard Bioscience, has agreed not to sell or transfer any common stock or securities convertible into, exchangeable for, exercisable for, or repayable with common stock for 120 days after the date of this prospectus, without first obtaining the written consent of Summer Street Research Partners. Specifically, we and these other persons have agreed not to directly or indirectly:

offer, pledge, sell or contract to sell any common stock,
sell any option or contract to purchase any common stock,
purchase any option or contract to sell any common stock,
grant any option, right or warrant for the sale of any common stock,
lend or otherwise dispose of or transfer any common stock,
request or demand that we file a registration statement related to the common stock, or
enter into any swap or other agreement that transfers, in whole or in part, the economic consequence of ownership of any common stock whether any such swap or transaction is to be settled by delivery of shares or other securities, in cash or otherwise.

The restrictions above do not apply to:

a bona fide gift or gifts,
transfers to any immediate family member of the holder or any trust for the direct or indirect benefit of the holder or the immediate family of the holder (“immediate family” meaning any relationship by blood, marriage or adoption, not more remote than first cousin),

108


 
 

TABLE OF CONTENTS

transfers by operation of law, including domestic relations orders, testate succession or intestate distribution,
forfeitures of shares of common stock or other company securities solely to the company in a transaction exempt from Section 16(b) of the Exchange Act in connection with the payment of taxes due upon the exercise of options to purchase common stock or vesting of other company securities pursuant to employee benefit plans as described in this prospectus,
distributions to limited partners, members, stockholders or other securityholders of the holder (or their equivalents under the jurisdiction of organization of the holder) or, if the holder is a trust, to the beneficiaries of the holder, or
transfers to the holder’s affiliates or to any investment fund or other entity controlled or managed by, or under common control or management by, the holder.

This lock-up provision applies to common stock and to securities convertible into or exchangeable or exercisable for or repayable with common stock. It also applies to common stock owned now or acquired later by the person executing the agreement or for which the person executing the agreement later acquires the power of disposition.

Price Stabilization, Short Positions and Penalty Bids

Until the distribution of the shares is completed, SEC rules may limit underwriters and selling group members from bidding for and purchasing our common stock. However, the representatives may engage in transactions that stabilize the price of the common stock, such as bids or purchases to peg, fix or maintain that price.

In connection with the offering, the underwriters may purchase and sell our common stock in the open market. These transactions may include short sales, purchases on the open market to cover positions created by short sales and stabilizing transactions. Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in the offering. “Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional shares described above. The underwriters may close out any covered short position by either exercising their option to purchase additional shares or purchasing shares in the open market. In determining the source of shares to close out the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the option granted to them. “Naked” short sales are sales in excess of such option. The underwriters must close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of our common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of shares of common stock made by the underwriters in the open market prior to the completion of the offering.

The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such underwriter in stabilizing or short covering transactions.

Similar to other purchase transactions, the underwriters’ purchases to cover the syndicate short sales may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. The underwriters may conduct these transactions on the NASDAQ Capital Market, in the over-the-counter market or otherwise.

Neither we nor any of the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor any of the underwriters make any representation that the representative will engage in these transactions or that these transactions, once commenced, will not be discontinued without notice.

Electronic Distribution

In connection with the offering, certain of the underwriters or securities dealers may distribute prospectuses by electronic means, such as e-mail.

109


 
 

TABLE OF CONTENTS

Other Relationships

Some of the underwriters and their affiliates have engaged in, and may in the future engage in, investment banking and other commercial dealings in the ordinary course of business with us or our affiliates. They have received, or may in the future receive, customary fees and commissions for these transactions.

In addition, in the ordinary course of their business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers. Such investments and securities activities may involve securities and/or instruments of ours or our affiliates. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

Notice to Prospective Investors in the European Economic Area

In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, or each, a Relevant Member State, with effect from and including the date on which the Prospectus Directive is implemented in that Relevant Member State, or the “Relevant Implementation Date,” no offer of shares may be made to the public in that Relevant Member State other than:

A. to any legal entity which is a qualified investor as defined in the Prospectus Directive;
B. to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representative; or
C. in any other circumstances falling within Article 3(2) of the Prospectus Directive,

provided that no such offer of shares shall require the company or the representative to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.

Each person in a Relevant Member State (other than a Relevant Member State where there is a Permitted Public Offer) who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed that (A) it is a “qualified investor” within the meaning of the law in that Relevant Member State implementing Article 2(1)(e) of the Prospectus Directive, and (B) in the case of any shares acquired by it as a financial intermediary, as that term is used in Article 3(2) of the Prospectus Directive, the shares acquired by it in the offering have not been acquired on behalf of, nor have they been acquired with a view to their offer or resale to, persons in any Relevant Member State other than “qualified investors” as defined in the Prospectus Directive, or in circumstances in which the prior consent of the representative has been given to the offer or resale. In the case of any shares being offered to a financial intermediary as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any shares to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or in circumstances in which the prior consent of the representative has been obtained to each such proposed offer or resale.

We, the representative and our and its affiliates will rely upon the truth and accuracy of the foregoing representation, acknowledgement and agreement.

This prospectus has been prepared on the basis that any offer of shares in any Relevant Member State will be made pursuant to an exemption under the Prospectus Directive from the requirement to publish a prospectus for offers of shares. Accordingly any person making or intending to make an offer in that Relevant Member State of shares which are the subject of the offering contemplated in this prospectus may only do so in circumstances in which no obligation arises for us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive in relation to such offer. Neither we nor the underwriters have

110


 
 

TABLE OF CONTENTS

authorized, nor do we or they authorize, the making of any offer of shares in circumstances in which an obligation arises for us or the underwriters to publish a prospectus for such offer.

For the purpose of the above provisions, the expression “an offer to the public” in relation to any shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase or subscribe the shares, as the same may be varied in the Relevant Member State by any measure implementing the Prospectus Directive in the Relevant Member State and the expression “Prospectus Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the expression “2010 PD Amending Directive” means Directive 2010/73/EU.

Notice to Prospective Investors in the United Kingdom

In addition, in the United Kingdom, this document is being distributed only to, and is directed only at, and any offer subsequently made may only be directed at persons who are “qualified investors” (as defined in the Prospectus Directive) (i) who have professional experience in matters relating to investments falling within Article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, or the Order, and/or (ii) who are high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This document must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this document relates is only available to, and will be engaged in with, relevant persons.

Notice to Prospective Investors in Switzerland

The shares may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX, or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering or marketing material relating to the shares or the offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this document nor any other offering or marketing material relating to the offering, us, the shares have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of shares will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA (FINMA), and the offer of shares has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of shares.

111


 
 

TABLE OF CONTENTS

LEGAL MATTERS

The validity of the shares of common stock offered by us in this offering will be passed upon for us by Burns & Levinson LLP, Boston, Massachusetts. Goodwin Procter LLP, New York, New York, is counsel for the underwriters.

EXPERTS

The financial statements of Harvard Apparatus Regenerative Technology as of December 31, 2011 and December 31, 2010, and the years ended December 31, 2011 and 2010, the period from February 24, 2009 (inception) to December 31, 2009 and for the period from February 24, 2009 (inception) to December 31, 2011, have been included herein and in the registration statement in reliance upon the report of KPMG LLP, independent registered public accounting firm, appearing elsewhere herein, and upon the authority of said firm as experts in auditing and accounting.

WHERE YOU CAN FIND MORE INFORMATION

We have filed a registration statement on Form S-1 with the SEC under the Securities Act with respect to the common stock offered by this prospectus. This prospectus is a part of that registration statement and, as allowed by SEC rules, does not include all of the information you can find in the registration statement or the exhibits to the registration statement. For additional information relating to our company and the distribution, reference is made to the registration statement and the exhibits to the registration statement. Statements contained in this prospectus as to the contents of any contract or document referred to are not necessarily complete and in each instance, if the contract or document is filed as an exhibit to the registration statement, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each such statement is qualified in all respects by reference to the applicable document.

As a result of this offering, we will become subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and will file annual, quarterly and special reports, proxy statements and other information with the SEC. We intend to furnish our stockholders with annual reports containing financial statements audited by an independent registered public accounting firm. The prospectus is, and any of these future filings with the SEC will be, available to the public over the Internet on the SEC’s web site at http://www.sec.gov . You may read and copy any filed document at the SEC’s public reference rooms in Washington, D.C. at 100 F Street, N.E., Washington, D.C. 20549 and at the SEC’s regional offices in New York at 233 Broadway, New York, New York 10279 and in Chicago at Citicorp Center, 500 W. Madison Street, Suite 1400, Chicago, Illinois 60661. Please call the SEC at 1-800-SEC-0330 for further information about the public reference rooms.

We will maintain an Internet site at http://www.harvardapparatusregen.com , which we expect to be operational on or before the date that the registration statement on Form S-1 is declared effective. Our web site and the information contained on that site, or connected to that site, are not incorporated into this prospectus or the registration statement on Form S-1.

112


 
 

TABLE OF CONTENTS

INDEX TO FINANCIAL STATEMENTS

F-1


 
 

TABLE OF CONTENTS

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors
Harvard Bioscience, Inc.:

We have audited the accompanying balance sheets of Harvard Apparatus Regenerative Technology, Inc., a business segment of Harvard Bioscience, Inc. and development stage company, (the Company) as of December 31, 2011 and 2010, and the related statements of operations, invested equity (deficit), and cash flows for the years ended December 31, 2011 and 2010, for the period from February 24, 2009 (inception) to December 31, 2009 and for the period from February 24, 2009 (inception) to December 31, 2011. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Harvard Apparatus Regenerative Technology, Inc., a business segment of Harvard Bioscience, Inc. and development stage company, as of December 31, 2011 and 2010, and the results of their operations and their cash flows for the years December 31, 2011 and 2010, for the period from February 24, 2009 (inception) to December 31, 2009, and for the period from February 24, 2009 (inception) to December 31, 2011, in conformity with U.S. generally accepted accounting principles.

/s/ KPMG LLP

Boston, Massachusetts
December 11, 2012

F-2


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

BALANCE SHEETS
(In thousands)

   
  December 31, 2011   December 31, 2010
ASSETS
            
 
Current assets:
                 
Cash and cash equivalents   $     $  
Accounts receivables, net            
Inventories, net            
Total current assets            
Property, plant and equipment, net     187       1  
Total non-current assets     187       1  
Total assets   $ 187     $ 1  
LIABILITIES AND INVESTED EQUITY (DEFICIT)
                 
Current liabilities:
                 
Accounts payable   $ 49     $ 52  
Accrued and other current liabilities     116       217  
Total current liabilities     165       269  
Total liabilities     165       269  
Invested equity (deficit):
                 
Harvard Bioscience investment     5,707       1,666  
Accumulated deficit     (5,685 )       (1,934 )  
Total invested equity (deficit)     22       (268 )  
Total liabilities and invested equity (deficit)   $ 187     $ 1  

 
 
See accompanying notes to financial statements.

F-3


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

STATEMENTS OF OPERATIONS
(In thousands)

       
  Years Ended December 31,   Period from February 24, 2009 (inception) to December 31, 2009   Period from February 24, 2009 (inception) to December 31, 2011
     2011   2010
Revenues   $     $     $     $  
Cost of product revenues                        
Gross profit                        
Selling and marketing expenses     215       53             268  
General and adminstrative expenses     1,251       572       188       2,011  
Research and development expenses     2,285       727       394       3,406  
Total operating expenses     3,751       1,352       582       5,685  
Operating loss     (3,751 )       (1,352 )       (582 )       (5,685 )  
Loss before income taxes     (3,751 )       (1,352 )       (582 )       (5,685 )  
Income taxes                        
Net loss   $ (3,751 )     $ (1,352 )     $ (582 )     $ (5,685 )  

 
 
See accompanying notes to financial statements.

F-4


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

STATEMENTS OF INVESTED EQUITY (DEFICIT)
(In thousands)

     
  Harvard Bioscience Investment   Accumulated Deficit   Total Invested Equity (Deficit)
Net loss from February 24, 2009 (inception) to December 31, 2009   $     $ (582 )     $ (582 )  
Investment by Harvard Bioscience     512             512  
Balance at December 31, 2009     512       (582 )       (70 )  
Net loss           (1,352 )       (1,352 )  
Investment by Harvard Bioscience     1,154             1,154  
Balance at December 31, 2010     1,666       (1,934 )       (268 )  
Net loss           (3,751 )       (3,751 )  
Investment by Harvard Bioscience     4,041             4,041  
Balance at December 31, 2011   $ 5,707     $ (5,685 )     $ 22  

 
 
See accompanying notes to financial statements.

F-5


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

STATEMENTS OF CASH FLOWS
(In thousands)

       
  Years Ended December 31,   Period from February 24, 2009 (inception) to December 31, 2009   Period from
February 24, 2009 (inception) to December 31, 2011
     2011   2010
Cash flows used in operating activities:
                                   
Net loss:   $ (3,751 )     $ (1,352 )     $ (582 )     $ (5,685 )  
Adjustments to reconcile net loss to net cash used in operating activities:
                                   
Stock-based compensation expense     261       105       31       397  
Depreciation     21                   21  
Changes in operating assets and liabilities:
                                   
(Decrease) increase in accounts payable     (3 )       46       6       49  
(Decrease) increase in accrued and other current liabilities     (101 )       153       64       116  
Net cash used in operating activities     (3,573 )       (1,048 )       (481 )       (5,102 )  
Cash flows used in investing activities:
                                   
Additions to property, plant and equipment     (207 )       (1 )             (208 )  
Net cash used in investing activities     (207 )       (1 )             (208 )  
Cash flows from financing activities:
                                   
Investment by Harvard Bioscience     3,780       1,049       481       5,310  
Net cash provided by financing activities     3,780       1,049       481       5,310  
Net increase (decrease) in cash and cash equivalents                        
Cash and cash equivalents at beginning of the period                        
Cash and cash equivalents at end of period   $     $     $     $  

 
 
See accompanying notes to financial statements.

F-6


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

1. Overview and Basis of Presentation

Overview

Harvard Apparatus Regenerative Technology, Inc. (“HART” or “the Company”) is a business segment of Harvard Bioscience, Inc. (“Harvard Bioscience” or “Parent”). The Company is engaged in the development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine.

Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets. Accordingly, HART is considered to be in the development stage.

HART is a wholly-owned subsidiary of Harvard Bioscience. HART was incorporated on May 3, 2012 by Harvard Bioscience to provide a means for separating its regenerative medicine device business from its other businesses. Harvard Bioscience has been designing and manufacturing devices for life science researchers for over 100 years. Harvard Bioscience first focused on providing devices to scientists involved in regenerative medicine research in 2008. Since early 2009, Harvard Bioscience’s regenerative medicine device business initiative has been operated as a division of Harvard Bioscience. Harvard Bioscience decided to separate its regenerative medicine device business into HART, a separate corporate entity, to authorize HART to raise capital by selling equity and then to spin off its interest in HART to its stockholders.

Basis of Presentation

The Company has historically operated as part of Harvard Bioscience, and not as a stand-alone company. The financial statements presented herein, and discussed below, have been prepared on a stand-alone basis and are derived from the financial statements and accounting records of Harvard Bioscience using the historical basis of assets and liabilities of HART. The financial statements reflect the Company’s financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States (“GAAP”).

The Company’s financial statements include expenses of Harvard Bioscience allocated to HART for certain functions provided by Harvard Bioscience, including, but not limited to, general corporate expenses related to executive services, finance, treasury, corporate income tax, human resources, legal services and investor relations. These expenses have been allocated to HART on the basis of headcount, time devoted to HART activities, percentage of operating expenses or other relevant measures. The Company believes the assumptions and allocations underlying the financial statements are reasonable and appropriate under the circumstances. Both HART and Harvard Bioscience consider the basis on which the expenses have been allocated to be a reasonable reflection of the utilization of services provided to or the benefits received by the Company during the periods presented. However, the amounts recorded for these transactions and allocations are not necessarily representative of the amounts that would have been reflected in the financial statements had HART been an entity that operated independently of Harvard Bioscience. Accordingly, the financial statements for these years are not necessarily indicative of the Company’s future results of operations, financial position, and cash flows.

Harvard Bioscience has historically used a centralized approach to cash management and financing of its operations. Transactions relating to HART are accounted for through the Harvard Bioscience investment account for HART. Accordingly, none of the cash, cash equivalents or debt at the Harvard Bioscience corporate level has been assigned to HART in the financial statements.

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

(a) Use of Estimates

The process of preparing financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying

F-7


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements  – (continued)

notes. Such estimates include, but are not limited to, stock-based compensation, accruals, depreciation and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

(b) Property, Plant and Equipment

Property, plant and equipment are carried at cost and depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 
Leasehold improvements     7 years  
Computer equipment and software     3 years  

Maintenance and repairs are charged to expense as incurred, while any additions or improvements are capitalized.

(c) Income Taxes

HART operations were historically included in Harvard Bioscience’s consolidated U.S. federal and certain state income tax returns. The provision for income taxes has been determined as if HART had filed separate tax returns for the periods presented. Accordingly, the effective tax rate of HART in future years could vary from its historical effective tax rates depending on the future legal structure of HART and related tax elections. The historical deferred tax assets, including the operating losses and credit carryforwards generated by HART, will remain with Harvard Bioscience subsequent to the separation.

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to be applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable.

Tax positions taken or expected to be taken in the course of preparing our tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year.

(d) Impairment of Long-Lived Assets

Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. An asset, or group of assets, are considered to be impaired when the undiscounted estimated net cash flows expected to be generated by the asset, or group of assets, are less than its carrying amount. The impairment recognized is the amount by which the carrying amount exceeds the fair market value of the impaired asset, or group of assets.

(e) Stock-based Compensation

Stock-based compensation expense for HART represents an allocation from Harvard Bioscience’s stock-based compensation expense for employees whose time has been allocated to HART.

Harvard Bioscience maintains the 2000 Stock Option and Incentive Plan (the “Plan”) for the benefit of certain of its officers, directors and employees, including HART employees. All options and awards granted under the Plan consist of Harvard Bioscience common shares.

F-8


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements  – (continued)

Harvard Bioscience accounts for stock-based payment awards in accordance with the provisions of FASB ASC 718, “ Compensation — Stock Compensation ,” which requires the Company to recognize compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units. Harvard Bioscience issues new shares upon stock option exercises and upon vesting of the restricted stock units.

Stock-based compensation expense recognized is based on the value of the portion of stock-based payment awards that is ultimately expected to vest and has been reduced for estimated forfeitures. Harvard Bioscience values stock-based payment awards, except restricted stock units, at grant date using the Black-Scholes option-pricing model. The determination of fair value of stock-based payment awards on the date of grant using an option-pricing model is affected by Harvard Bioscience’s stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to Harvard Bioscience’s expected stock price volatility over the term of the awards and actual and projected employee stock option exercise behaviors.

The fair value of restricted stock units are based on the market price of Harvard Bioscience’s stock on the date of grant and are recorded as compensation expense ratably over the applicable service period, which is generally four years. Unvested restricted stock units are forfeited in the event of termination of employment or engagement with Harvard Bioscience.

(f) Research and Development

Research and development costs are charged to expense as incurred. Research and development costs consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, including stock-based compensation; costs associated with regulatory filings, laboratory and other supplies; and related facility maintenance.

(g) Harvard Bioscience, Inc. Investment

The financial statements of HART represent a combination of various components of Harvard Bioscience. Because a direct ownership relationship did not exist among all the components comprising HART, Harvard Bioscience’s investment in HART is shown in lieu of stockholder’s equity in the financial statements.

(h) Segment Reporting

The Company operates in one segment. The Company is engaged in the development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine.

(i) Recently Issued Accounting Pronouncements

There are no recently issued accounting standards which are not yet effective which the Company believes would materially impact the financial statements.

3. Liquidity

The Company has incurred operating losses and negative cash flow since inception, and had an accumulated deficit of $5.7 million as of December 31, 2011. Since inception, the Company has received funding for operating losses from Harvard Bioscience. The Company is currently investing significant resources in development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine. The Company expects to continue to incur operating losses and negative cash flows. Harvard Bioscience will continue to fund the Company’s business activities into 2013.

F-9


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

4. Related Party Transactions

Cost Allocations

For each of the periods presented, HART’s operations were fully integrated with Harvard Bioscience, including executive services, finance, treasury, corporate income tax, human resources, legal services and investor relations. The accompanying financial statements reflect the application of certain estimates and allocations of operating expenses and the Company believes the methods used to allocate these operating expenses are reasonable. The allocation methods include time devoted to HART activities, headcount, percentage of operating expenses or other relevant measures. Allocation of expenses for these services of $0.7 million, $0.4 million and $0.2 million for the years ended December 31, 2011 and 2010 and for the period from February 24, 2009 (inception) to December 31, 2009, respectively, are reflected in the total operating expenses in the statements of operations, in addition to direct expenses. The Company’s financial statements may not be indicative of the future performance and do not necessarily reflect what the results of operations, financial position and cash flows would have been had the Company operated as an independent, publicly-traded company during the periods presented.

5. Property, Plant and Equipment

Property, plant and equipment consist of the following:

   
  December 31,
     2011   2010
     (in thousands)
Leasehold improvements   $ 115     $  
Computer equipment and software     85       1  
Capital work in progress     8        
       208       1  
Less: accumulated depreciation     (21 )        
Property, plant and equipment, net   $ 187     $ 1  

6. Leases

Harvard Bioscience leases certain real and personal property from unrelated third parties under non-cancelable operating leases. Total rent expense allocations were $18,313 and $12,016 for the years ended December 31, 2011 and 2010, respectively.

F-10


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

7. Accrued Expenses

Accrued expenses consist of:

   
  December 31,
     2011   2010
     (in thousands)
Accrued compensation and payroll   $ 21     $ 114  
Other     95       103  
Total   $ 116     $ 217  

8. Stock-Based Compensation

Stock-based compensation expense for HART represents an allocation from Harvard Bioscience’s stock-based compensation expense for employees whose time has been allocated to HART.

Harvard Bioscience maintains the Plan for the benefit of certain of its officers, directors and employees. The following disclosure represents the Company’s portion of the Plan maintained by Harvard Bioscience in which the employees participated. All options and awards granted under the Plan consist of Harvard Bioscience common shares. Accordingly, the amounts presented are not necessarily indicative of future performance and do not necessarily reflect the results that the Company would have experienced as an independent, publicly-traded company for the periods presented.

Employee options and awards become fully vested over a period of approximately three years and seven months, with the first quarter vesting after approximately seven months of the grant date and the remaining vesting equally over a period of three years thereafter.

The fair value of options granted was determined using the Black-Scholes option-pricing model. The determination of fair value on the date of the grant is affected by the grant date market price of Harvard Bioscience common shares and a number of other variables. These variables include, but are not limited to the expected stock price volatility of Harvard Bioscience common shares over the term of the awards and actual and projected employee stock option exercise behaviors. The fair value of restricted stock units was determined by the number of shares granted and the grant date market price of Harvard Bioscience common shares.

The compensation expense recognized for all equity-based awards is net of estimated forfeitures and is recognized using the straight-line method over the applicable service period.

F-11


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

8. Stock-Based Compensation  – (continued)

The following summarizes all transactions under the Plan from February 24, 2009 (inception) to December 31, 2011 allocated to the Company:

       
  Stock Options   Restricted Stock Units
     Stock
Options Outstanding
  Weighted Average Exercise
Price
  Restricted Stock Units Outstanding   Grant Date
Fair Value
Granted from February 24, 2009 (inception) to December 31, 2009     95,100     $ 3.18           $  
Exercised                        
Cancelled/forfeited                        
Balance at December 31, 2009     95,100       3.18              
Granted     60,763       3.61       54,108       3.61  
Exercised                        
Cancelled/forfeited                        
Balance at December 31, 2010     155,863       3.35       54,108       3.61  
Granted     167,106       5.64       38,688       5.64  
Exercised                        
Vested (RSUs)                 (13,527 )        
Cancelled/forfeited                        
Balance at December 31, 2011     322,969     $ 4.53       79,269     $ 4.60  

The following table summarizes information concerning currently outstanding and exercisable options as of December 31, 2011 (Aggregate Intrinsic Value, in thousands):

             
  Options Outstanding   Options Exercisable
Range of
Exercise
Price
  Number Outstanding at December 31, 2011   Weighted Average Remaining Contractual Life in Years   Weighted Average Exercise Price   Aggregate Intrinsic Value   Shares Exercisable at December 31, 2011   Weighted Average Exercise Price   Aggregate
Intrinsic Value
$3.18 – 3.18
    95,100       7.39     $ 3.18     $ 66       49,350     $ 3.18     $ 34  
3.61 – 3.61
    60,763       8.43       3.61       16       16,901       3.61       4  
5.64 – 5.64
    167,106       9.42       5.64                   5.64        
$3.18 – 5.64
    322,969       8.63     $ 4.53     $ 82       66,251     $ 3.29     $ 38  

The aggregate intrinsic value in the preceding table represents the total pre-tax intrinsic value based on Harvard Bioscience’s closing stock price of $3.87 as of December 31, 2011, which would have been received by the option holders had all option holders exercised their options as of that date. The total number of in-the-money options that were exercisable as of December 31, 2011 was 66,251.

For the year ended December 31, 2011, the total compensation costs related to unvested awards not yet recognized is $0.8 million and the weighted average period over which it is expected to be recognized is 2.67 years.

F-12


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

8. Stock-Based Compensation  – (continued)

Stock-based compensation expense related to employee stock options and restricted stock units for the years ended December 31, 2011 and 2010 and for the period from February 24, 2009 (inception) to December 31, 2009 was allocated as follows:

     
  Years Ended December 31,   Period from February 24, 2009
(inception) to
December 31, 2009
     2011   2010
     (in thousands)
General and administrative   $ 208     $ 85     $ 27  
Research and development     53       20       4  
Total stock-based compensation   $ 261     $ 105     $ 31  

The Company did not capitalize any stock-based compensation.

The weighted-average estimated value of employee stock options granted during 2011, 2010 and 2009 was $2.94, $1.97 and $1.93, respectively, using the Black-Scholes option-pricing model with the following weighted-average assumptions:

     
  Years Ended December 31,
     2011   2010   2009
Volatility     54.24 %       55.96 %       62.85 %  
Risk-free interest rate     2.01 %       2.22 %       2.50 %  
Expected holding period     5.94 years       6.13 years       6.27 years  
Dividend yield     0 %       0 %       0 %  

The expected holding period represents an estimate of the period of time options are expected to remain outstanding and is based on historical exercise and termination data. The risk-free interest rate is based upon the observed Treasury bill interest rates with a term that approximates the expected holding period of the option. Expected volatilities are based on the historical volatility of Harvard Bioscience’s stock price over the expected holding period of the options.

9. Income Taxes

HART operations were historically included in Harvard Bioscience’s consolidated U.S. federal and certain state income tax returns. The provision for income taxes has been determined as if HART had filed separate tax returns for the periods presented. Accordingly, the effective tax rate of HART in future years could vary from its historical effective tax rates depending on the future legal structure of HART and related tax elections. The historical deferred tax assets, including the operating loss and credit carryforwards, generated by HART, will remain with Harvard Bioscience subsequent to the separation.

F-13


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

9. Income Taxes  – (continued)

Income taxes for the years ended December 31, 2011 and 2010 and for the period from February 24, 2009 (inception) to December 31, 2009 differed from the amount computed by applying the U.S. federal income tax rate of 34% to pre-tax continuing operations loss as a result of the following:

     
  Years ended December 31,   Period from February 24, 2009 (inception) to December 31, 2009
     2011   2010
     (in thousands)
Computed “expected” income tax benefit   $ (1,275 )     $ (460 )     $ (198 )  
Increase (decrease) in income taxes resulting from: Foreign tax rate and regulation differential     35       9        
State income taxes, net of federal
income tax benefit
    (225 )       (81 )       (35 )  
Non-deductible stock-based compensation expense     27       9       3  
Tax credits     (167 )       (52 )       (31 )  
Change in valuation allowance allocated to income tax expense     1,605       575       261  
Total income taxes   $     $     $  

Income taxes are based on the following pre-tax continuing operations loss for the years ended December 31, 2011 and 2010 and for the period from February 24, 2009 (inception) through December 31, 2009:

     
  Years ended December 31,   Period from February 24, 2009 (inception) to December 31, 2009
     2011   2010
     (in thousands)
Domestic   $ (3,456 )     $ (1,276 )     $ (582 )  
Foreign     (295 )       (76 )        
Total   $ (3,751 )     $ (1,352 )     $ (582 )  

The components of HART’s deferred taxes at December 31, 2011 and 2010 are as follows:

   
  December 31,
     2011   2010
     (in thousands)
Deferred tax assets:
                 
Operating loss and credit carryforwards   $ 2,344     $ 794  
Stock-based compensation     97       42  
Total deferred tax assets     2,441       836  
Less: valuation allowance     (2,441 )       (836 )  
Deferred tax assets, net   $     $  

The amounts recorded as deferred tax assets as of December 31, 2011 and 2010 represent the amount of tax benefits of existing deductible temporary differences or carryforwards that are more likely than not to be realized through the generation of sufficient future taxable income within the carryforward period. Significant management judgment is required in determining any valuation allowance recorded against deferred tax assets

F-14


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO FINANCIAL STATEMENTS

9. Income Taxes  – (continued)

and liabilities. Due to the operating results, the Company’s cumulative loss position and uncertainty surrounding its forecasts, the Company concluded that a full valuation allowance was needed to offset its deferred tax assets.

At December 31, 2011, the Company had federal, state and foreign net operating loss carryforwards available to offset future taxable income of approximately $5.3 million. The operating loss carryforwards will begin to expire in 2029. The Company also had federal and state general business credit carryforwards available to reduce future federal and state regular income taxes of approximately $0.3 million, which begin to expire in 2019. As mentioned above, net operating loss and credit carryforwards have full valuation allowances set up against them.

Total valuation allowances for deferred tax assets as of December 31, 2011 were $2.4 million.

At December 31, 2011, the Company had recorded no liabilities related to uncertain tax positions.

10. Commitments and Contingent Liabilities

From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that the Company expects to be material in relation to the business, financial condition, results of operations or cash flows.

11. Subsequent Events

The Company has evaluated all events subsequent to the balance sheet date of December 31, 2011, through December 11, 2012, which is the date these financial statements were issued, and have determined that there are no subsequent events that require disclosure.

F-15


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

BALANCE SHEETS
(unaudited, in thousands)

   
  September 30, 2012   December 31, 2011
ASSETS
                 
Current assets:
                 
Cash and cash equivalents   $     $  
Accounts receivables, net            
Inventories, net            
Total current assets            
Property, plant and equipment, net     295       187  
Total non-current assets     295       187  
Total assets   $ 295     $ 187  
LIABILITIES AND INVESTED EQUITY
                 
Current liabilities:
                 
Accounts payable   $ 23     $ 49  
Accrued and other current liabilities     132       116  
Total current liabilities     155       165  
Total liabilities     155       165  
Invested equity:
                 
Common stock, par value $0.01 per share, 100 shares authorized; 10 shares issued and outstanding in 2012 and 0 shares issued and outstanding in 2011            
Harvard Bioscience investment     10,572       5,707  
Accumulated deficit     (10,432 )       (5,685 )  
Total invested equity     140       22  
Total liabilities and invested equity   $ 295     $ 187  

 
 
See accompanying notes to unaudited financial statements.

F-16


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

STATEMENTS OF OPERATIONS
(unaudited, in thousands)

     
  Nine months ended September 30,   Period from February 24, 2009
(inception) to
September 30, 2012
     2012   2011
Revenues   $     $     $  
Cost of product revenues                  
Gross profit                  
Selling and marketing expenses     91       68       359  
General and adminstrative expenses     1,631       753       3,642  
Research and development expenses     3,025       1,679       6,431  
Total operating expenses     4,747       2,500       10,432  
Operating loss     (4,747 )       (2,500 )       (10,432 )  
Loss before income taxes     (4,747 )       (2,500 )       (10,432 )  
Income taxes                  
Net loss   $ (4,747 )     $ (2,500 )     $ (10,432 )  

 
 
See accompanying notes to unaudited financial statements.

F-17


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)

STATEMENTS OF CASH FLOWS
(unaudited, in thousands)

     
  Nine months ended September 30,   Period from February 24, 2009 (inception) to September 30, 2012
     2012   2011
Cash flows used in operating activities:
                          
Net loss:   $ (4,747 )     $ (2,500 )     $ (10,432 )  
Adjustments to reconcile net loss to net cash used in operating activities:
                          
Stock-based compensation expense     349       174       746  
Depreciation     38       7       59  
Changes in operating assets and liabilities:
                          
(Decrease) increase in accounts payable     (26 )       125       23  
Increase (decrease) in accrued and
other current liabilities
    16       (136 )       132  
Net cash used in operating activities     (4,370 )       (2,330 )       (9,472 )  
Cash flows used in investing activities:
                          
Additions to property, plant and equipment     (146 )       (119 )       (354 )  
Net cash used in investing activities     (146 )       (119 )       (354 )  
Cash flows from financing activities:
                          
Investment by Harvard Bioscience     4,516       2,449       9,826  
Net cash provided by financing activities     4,516       2,449       9,826  
Net increase (decrease) in cash and cash equivalents                  
Cash and cash equivalents at beginning of the period                  
Cash and cash equivalents at end of period   $     $     $  

 
 
See accompanying notes to unaudited financial statements.

F-18


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO UNAUDITED FINANCIAL STATEMENTS

1. Overview and Basis of Presentation

Overview

Harvard Apparatus Regenerative Technology, Inc. (“HART” or “the Company”) is a business segment of Harvard Bioscience, Inc. (“Harvard Bioscience” or “Parent”). The Company is engaged in the development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine.

Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and acquiring operating assets. Accordingly, HART is considered to be in the development stage.

HART is a wholly-owned subsidiary of Harvard Bioscience. HART was incorporated on May 3, 2012 by Harvard Bioscience to provide a means for separating its regenerative medicine device business from its other businesses. Harvard Bioscience has been designing and manufacturing devices for life science researchers for over 100 years. Harvard Bioscience first focused on providing devices to scientists involved in regenerative medicine research in 2008. Since early 2009, Harvard Bioscience’s regenerative medicine device business initiative has been operated as a division of Harvard Bioscience. Harvard Bioscience decided to separate its regenerative medicine device business into HART, a separate corporate entity, to authorize HART to raise capital by selling equity and then to spin off its interest in HART to its stockholders.

In connection with the separation, the Company expects to enter into a series of agreements with Harvard Bioscience, including a separation and distribution agreement, transition services agreement, a tax sharing agreement, sublicense agreement, other commercial agreements, and a sublease agreement. Consummation of the separation is subject to certain conditions, including approval for listing of HART common stock on an exchange, and the effectiveness of the registration statement filed with the Securities and Exchange Commission in connection with the separation. Approval by Harvard Bioscience’s stockholders is not required as a condition to the consummation of the proposed separation.

Basis of Presentation

The Company has historically operated as part of Harvard Bioscience, and not as a stand-alone company. The financial statements presented herein, and discussed below, have been prepared on a stand-alone basis and are derived from the financial statements and accounting records of Harvard Bioscience using the historical basis of assets and liabilities of HART. The financial statements reflect the Company’s financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States (“GAAP”).

The Company’s financial statements include expenses of Harvard Bioscience allocated to HART for certain functions provided by Harvard Bioscience, including, but not limited to, general corporate expenses related to executive services, finance, treasury, corporate income tax, human resources, legal services and investor relations. These expenses have been allocated to HART on the basis of headcount, time devoted to HART activities, percentage of operating expenses or other relevant measures. The Company believes the assumptions and allocations underlying the financial statements are reasonable and appropriate under the circumstances. Both HART and Harvard Bioscience consider the basis on which the expenses have been allocated to be a reasonable reflection of the utilization of services provided to or the benefits received by the Company during the periods presented. However, the amounts recorded for these transactions and allocations are not necessarily representative of the amounts that would have been reflected in the financial statements had HART operated independently of Harvard Bioscience. Accordingly, the financial statements for these years are not necessarily indicative of the Company’s future results of operations, financial position, and cash flows.

Harvard Bioscience has historically used a centralized approach to cash management and financing of its operations. Transactions relating to HART are accounted for through the Harvard Bioscience investment

F-19


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO UNAUDITED FINANCIAL STATEMENTS

1. Overview and Basis of Presentation  – (continued)

account for HART. Accordingly, none of the cash, cash equivalents or debt at the Harvard Bioscience corporate level has been assigned to HART in the financial statements.

The unaudited financial statements of HART as of September 30, 2012 and for the nine months ended September 30, 2012 and 2011 and for the period from February 24, 2009 (inception) to September 30, 2012 have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial reporting. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations.

2. Summary of Significant Accounting Policies and Recently Issued Accounting Pronouncements

The accounting policies underlying the accompanying unaudited financial statements are those set forth in Note 2 to the audited financial statements included in this document.

(a) Unaudited Interim Financial Information

The accompanying interim balance sheet as of September 30, 2012, statements of operations and cash flows for the nine months ended September 30, 2012 and 2011 and for the period from February 24, 2009 (inception) to September 30, 2012 are unaudited. The interim unaudited financial statements have been prepared in accordance with GAAP on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2012 and the results of its operations and cash flows for the nine months ended September 30, 2012 and 2011 and for the period from February 24, 2009 (inception) to September 30, 2012. The financial data and other information disclosed in these notes related to the nine month periods ended September 30, 2012 and 2011 and for the period from February 24, 2009 (inception) to September 30, 2012 are unaudited. The results for the nine months ended September 30, 2012 and 2011 and for the period from February 24, 2009 (inception) to September 30, 2012 are not necessarily indicative of results to be expected for the year ending December 31, 2012, any other interim periods or any future year or period.

(b) Recently Issued Accounting Pronouncements

There are no recently issued accounting standards which are not yet effective which the Company believes would materially impact the financial statements.

3. Liquidity

The Company has incurred operating losses and negative cash flow since inception, and had an accumulated deficit of $10.4 million as of September 30, 2012. Since inception, the Company has received funding for operating losses from Harvard Bioscience. The Company is currently investing significant resources in development and commercialization of devices for use by clinicians and researchers in the field of regenerative medicine. The Company expects to continue to incur operating losses and negative cash flows. Harvard Bioscience will continue to fund the Company’s business activities into 2013.

4. Related Party Transactions

Cost Allocations

For each of the periods presented, HART’s operations were fully integrated with Harvard Bioscience, including executive services, finance, treasury, corporate income tax, human resources, legal services and investor relations. The accompanying financial statements reflect the application of certain estimates and allocations of operating expenses and the Company believes the methods used to allocate these operating expenses are reasonable. The allocation methods include time devoted to HART activities, headcount, percentage of operating expenses or other relevant measures. Allocation of expenses for these services of

F-20


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO UNAUDITED FINANCIAL STATEMENTS

4. Related Party Transactions  – (continued)

$0.8 million and $0.5 million for the periods ended September 30, 2012 and 2011, respectively, are reflected in the total operating expenses in the statements of operations, in addition to direct expenses. The Company’s financial statements may not be indicative of the future performance and do not necessarily reflect what the results of operations, financial position and cash flows would have been had the Company operated as an independent, publicly-traded company during the periods presented.

Agreements with Harvard Bioscience

In connection with the separation, the Company expects to enter into a series of agreements with Harvard Bioscience, including a separation and distribution agreement, transition services agreement, a tax sharing agreement, sublicense agreement, other commercial agreements, and a sublease agreement. Some of these agreements will require the Company to pay fees to Harvard Bioscience for services provided subsequent to the separation.

5. Stock-Based Compensation

Stock-based compensation expense for HART represents an allocation from Harvard Bioscience’s stock-based compensation expense for employees whose time has been allocated to HART.

Harvard Bioscience maintains the 2000 Stock Option and Incentive Plan (the “Plan”) for the benefit of certain of its officers, directors and employees. The following disclosure represents the Company’s portion of the Plans maintained by Harvard Bioscience in which the employees participated. All options and awards granted under the Plan consist of Harvard Bioscience common shares. Accordingly, the amounts presented are not necessarily indicative of future performance and do not necessarily reflect the results that the Company would have experienced as an independent, publicly-traded company for the periods presented.

Employee options and awards become fully vested over a period of approximately three years and seven months, with the first quarter vesting after approximately seven months of the grant date and the remaining vesting equally over a period of three years thereafter.

The fair value of options granted was determined using the Black-Scholes option-pricing model. The determination of fair value on the date of the grant is affected by the grant date market price of Harvard Bioscience common shares and a number of other variables. These variables include, but are not limited to the expected stock price volatility of Harvard Bioscience common shares over the term of the awards and actual and projected employee stock option exercise behaviors. The fair value of restricted stock units was determined by the number of shares granted and the grant date market price of Harvard Bioscience common shares.

The compensation expense recognized for all equity-based awards is net of estimated forfeitures and is recognized using the straight-line method over the applicable service period.

F-21


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO UNAUDITED FINANCIAL STATEMENTS

5. Stock-Based Compensation  – (continued)

The following summarizes all transactions under the Plan from January 1, 2012 through September 30, 2012 allocated to the Company:

       
  Stock Options   Restricted Stock Units
     Stock
Options Outstanding
  Weighted Average Exercise
Price
  Restricted
Stock Units Outstanding
  Grant Date
Fair Value
Balance at December 31, 2011     322,969     $ 4.53       79,269     $ 4.60  
Granted     286,547       3.57       128,194       3.57  
Exercised                        
Vested (RSUs)                 (23,199 )        
Cancelled/forfeited                        
Balance at September 30, 2012     609,516     $ 4.08       184,264     $ 3.90  

The following assumptions were used to estimate the fair value of stock options and restricted stock units granted during the nine month periods ended September 30, 2012 and 2011:

   
  Nine months ended September 30,
     2012   2011
Volatility     55.09 %       54.24 %  
Risk-free interest rate     0.80 %       2.01 %  
Expected holding period     5.98 years       5.94 years  
Dividend yield     0 %       0 %  

Stock options and restricted stock units granted during the nine months ended September 30, 2012 were 286,547 and 128,194, respectively. Stock options and restricted stock units granted during the nine months ended September 30, 2011 were 167,106 and 38,688, respectively.

The weighted average fair values of the options granted under the 2000 Plan during the nine months ended September 30, 2012 and September 30, 2011 was $1.84 and $2.94, respectively, using the Black Scholes option-pricing model.

The expected holding period represents an estimate of the period of time options are expected to remain outstanding and is based on historical exercise and termination data. The risk-free interest rate is based upon the observed Treasury bill interest rates with a term that approximates the expected holding period of the option. Expected volatilities are based on the historical volatility of Harvard Bioscience’s stock price over the expected holding period of the options.

Stock-based compensation expense for the nine months ended September 30, 2012 and 2011 consisted of stock-based compensation expense related to employee stock options and restricted stock units.

F-22


 
 

TABLE OF CONTENTS

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
A BUSINESS SEGMENT OF HARVARD BIOSCIENCE, INC.
(A Development Stage Company)
 
NOTES TO UNAUDITED FINANCIAL STATEMENTS

5. Stock-Based Compensation  – (continued)

Stock-based compensation expense for the nine months ended September 30, 2012 and 2011, was allocated as follows:

   
  Nine months ended September 30,
     2012   2011
     (in thousands)
Sales and marketing   $ 1     $  
General and administrative     60       35  
Research and development     288       139  
Total stock-based compensation   $ 349     $ 174  

The Company did not capitalize any stock-based compensation.

6. Income Taxes

HART operations were historically included in Harvard Bioscience’s consolidated U.S. federal and certain state income tax returns. The provision for income taxes has been determined as if HART had filed separate tax returns for the periods presented. Accordingly, the effective tax rate of HART in future years could vary from its historical effective tax rates depending on the future legal structure of HART and related tax elections. The historical deferred tax assets, including the operating loss and credit carryforwards generated by HART, will remain with Harvard Bioscience subsequent to the separation.

At September 30, 2012 and December 31, 2011, the Company had deferred tax assets of $4.5 million and $2.4 million, respectively, which principally relate to net operating loss carryforwards. The Company has a full valuation allowance on its deferred tax assets. Significant management judgment is required in determining any valuation allowance recorded against deferred tax assets and liabilities. Due to the operating results, the Company’s cumulative loss position and uncertainty surrounding its forecasts, the Company concluded that a full valuation allowance was needed to offset its deferred tax assets.

7. Commitments and Contingent Liabilities

From time to time, the Company may be involved in various claims and legal proceedings arising in the ordinary course of business. There are no such matters pending that the Company expects to be material in relation to our business, financial condition, results of operations or cash flows.

8. Subsequent Events

The Company has evaluated all events subsequent to the balance sheet date of September 30, 2012, through December 11, 2012, which is the date these financial statements were issued, and have determined that there are no subsequent events that require disclosure.

F-23


 
 

TABLE OF CONTENTS

 

 

 

[GRAPHIC MISSING]


 
 
 
 

Shares of Common Stock


 
 
 
 
 


PROSPECTUS

 


 
 
 
 

Summer Street Research Partners


 
 
 
 

           , 2013

 

 


 
 

TABLE OF CONTENTS

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution

The following table sets forth the costs and expenses payable by us in connection with the sale of the securities being registered. All such costs and expenses shall be borne by us. All amounts are estimates except the fees payable to the SEC.

 
SEC Registration Fee   $ 2,728  
FINRA filing fee     3,500  
Printing and Edgar Filing     *  
Accounting Fees and Expenses     *  
Legal Fees and Expenses     *  
Miscellaneous     *  
Total   $ *  

* To be filed by amendment.

Item 14. Indemnification of Directors and Officers

Section 145 of the Delaware General Corporation Law authorizes a court to award, or a corporation's board of directors to grant, indemnity to directors and officers under certain circumstances and subject to certain limitations. The terms of Section 145 of the Delaware General Corporation Law are sufficiently broad to permit indemnification under certain circumstances for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or Securities Act.

As permitted by the Delaware General Corporation Law, the registrant's amended and restated certificate of incorporation contains provisions that eliminate the personal liability of its directors for monetary damages for any breach of fiduciary duties as a director, except for liability:

for any breach of the director's duty of loyalty to the registrant or its stockholders;
for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;
under Section 174 of the Delaware General Corporation Law (regarding unlawful dividends and stock purchases); or
for any transaction from which the director derived an improper personal benefit.

As permitted by the Delaware General Corporation Law, the registrant's amended and restated certificate of incorporation and amended and restated by-laws provide that:

the registrant is required to indemnify its directors and officers to the fullest extent permitted by the Delaware General Corporation Law, subject to very limited exceptions;
the registrant may indemnify its other employees and agents as set forth in the Delaware General Corporation Law;
the registrant is required to advance expenses, as incurred, to its directors and officers in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to very limited exceptions; and
the rights conferred in the amended and restated certificate of incorporation and the amended and restated bylaws are not exclusive.

The registrant has entered into indemnification agreements with each of its current directors and certain executive officers to provide these directors and executive officers additional contractual assurances regarding the scope of the indemnification set forth in the registrant's amended and restated certificate of incorporation

II-1


 
 

TABLE OF CONTENTS

and amended and restated bylaws and to provide additional procedural protections. At present, there is no pending litigation or proceeding involving a director, executive officer or employee of the registrant regarding which indemnification is sought. Reference is also made to Section      of the Underwriting Agreement, which provides for the indemnification of executive officers, directors and controlling persons of the registrant against certain liabilities. The indemnification provisions in the registrant's amended and restated certificate of incorporation and amended and restated bylaws and the indemnification agreements entered into or to be entered into between the registrant and each of its directors and executive officers may be sufficiently broad to permit indemnification of the registrant's directors and executive officers for liabilities arising under the Securities Act.

The registrant has directors' and officers' liability insurance for securities matters.

Reference is made to the following documents filed as exhibits to this Registration Statement regarding relevant indemnification provisions described above and elsewhere herein:

 
Exhibit Document   Number
Form of Underwriting Agreement   1.1
Amended and Restated Certificate of Incorporation of the Registrant   3.3
Amended and Restated Bylaws of the Registrant   3.4
Form of Director and Officer Indemnification Agreement   10.6     

Item 15. Recent Sales of Unregistered Securities

Registrant has not sold any securities, registered or otherwise, within the past three years, except for the shares issued upon formation to registrant’s sole stockholder, Harvard Bioscience.

Item 16. Exhibits and Financial Statement Schedules

(a) Exhibits.   The following exhibits are included herein:

 
Exhibit
Number
  Description of Exhibit
 1.1**    Underwriting Agreement
 3.1*     Certificate of Incorporation of Registrant
 3.2*     By-laws of the Registrant
 3.3**    Form of Amended and Restated Certificate of Incorporation of the Registrant (to be effective upon or prior to the closing of this offering)
 3.4**    Form of Amended and Restated By-laws of the Registrant (to be effective upon or prior to the closing of this offering)
 3.5**    Form of Certificate of Designations, Preferences and Rights of a Series of Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series A Junior Participating Cumulative Preferred Stock (to be effective upon or immediately prior to the closing of this offering)
 4.1**    Specimen Stock Certificate evidencing the shares of common stock
 4.2**    Form of Shareholders Rights Agreement between Harvard Apparatus Regenerative Technology, Inc., and Registrar and Transfer Company, as Rights Agent (to be effective upon or immediately prior to the closing of this offering)
 5.1**    Opinion of Burns & Levinson LLP
10.1**    Form of Separation and Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.2**    Form of Transition Services Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.3**    Form of Tax Matters Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.4**#   Form of Employment Agreement between Harvard Apparatus Regenerative Technology, Inc. and David Green

II-2


 
 

TABLE OF CONTENTS

 
10.5**#    Form of Employment Agreement between Harvard Apparatus Regenerative Technology, Inc. and Thomas McNaughton
10.6**     Form of Director and Officer Indemnification Agreement
10.7**     Form of 2013 Equity Incentive Plan
10.8**     Form of Employee Stock Purchase Plan
10.9**     Form of Non-Qualified Stock Option Agreement
10.10**    Form of Incentive Stock Option Agreement
10.11**    Form of Non-Qualified Stock Option Agreement for executive officers
10.12**    Form of Non-Qualified Stock Option Agreement for directors
10.13**    Form of Deferred Stock Award Agreement
10.14**#   Director Compensation Arrangements
10.15†     Sublicense Agreement dated as of December 7, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc., and related Trademark License Agreement, dated December 19, 2002, by and between Harvard Bioscience, Inc. and President and Fellows of Harvard College.
10.16†     Form of Product Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.17†     Form of Intellectual Property Matters Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.18      Patent Rights Assignment dated December 21, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Dr. Paolo Macchiarini.
10.19†     Exclusive License Agreement dated August 6, 2009 by and between Harvard Apparatus Regenerative Technology, Inc. (as assignee of Harvard Bioscience, Inc.) and Sara Mantero and Maria Adelaide Asnaghi.
10.20      Sponsored Research Agreement dated August 5, 2009 by and among Harvard Apparatus Regenerative Technology, Inc. (as assignee of Harvard Bioscience, Inc.), Sara Mantero, Maria Adelaide Asnaghi, and Department of Bioengineering of the Politecnico Di Milano
10.21      Novel Surgery Agreement dated as of May 21, 2012 between Harvard Apparatus Regenerative Technology, Inc. and State Budget Institution of Public Health Department Regional Clinical Hospital #1 and Vladimir Alekseevich Porhanov.
10.22      Novel Surgery Agreement dated as of May 24, 2012 between Harvard Apparatus Regenerative Technology, Inc. and OSF Healthcare System, owner and operator of Saint Francis Medical Center and Children’s Hospital of Illinois, and Mark Holterman, M.D.
10.23**    Form of Sublease between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
21         Subsidiaries of the Registrant
23.1       Consent of KPMG LLP
23.2**     Consent of Burns & Levinson LLP (included in Exhibit 5.1)
24.1*      Power of Attorney (included on signature page)

* Previously filed.
** To be filed by amendment.
Confidential portions of this exhibit (indicated by asterisks) have been redacted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
# Management contract or compensatory plan or arrangement.

II-3


 
 

TABLE OF CONTENTS

Item 17. Undertakings

The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-4


 
 

TABLE OF CONTENTS

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Amendment No. 2 to the registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Holliston, Commonwealth of Massachusetts, on February 15, 2013.

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

By: /s/ David Green

Name: David Green
Title: President and Chief Executive Officer

Pursuant to the requirements of the Securities Act of 1933, this Amendment No. 2 to the registration statement has been signed by the following persons in the capacities and on the dates indicated.

   
Signature   Title   Date
/s/ David Green

David Green
  President and Chief Executive Officer and Chairman (Principal Executive Officer)   February 15, 2013
/s/ Thomas McNaughton

Thomas McNaughton
  Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)   February 15, 2013
*

Chane Graziano
  Director   February 15, 2013
*

John F. Kennedy
  Director   February 15, 2013
*
Thomas Robinson
  Director   February 15, 2013
*By: /s/ David Green        
David Green, Attorney-in-Fact


 
 

TABLE OF CONTENTS

 
Exhibit
Number
  Description of Exhibit
 1.1**    Underwriting Agreement
 3.1*     Certificate of Incorporation of Registrant
 3.2*     By-laws of the Registrant
 3.3**    Form of Amended and Restated Certificate of Incorporation of the Registrant (to be effective upon or prior to the closing of this offering)
 3.4**    Form of Amended and Restated By-laws of the Registrant (to be effective upon or prior to the closing of this offering)
 3.5**    Form of Certificate of Designations, Preferences and Rights of a Series of Preferred Stock of Harvard Apparatus Regenerative Technology, Inc. classifying and designating the Series A Junior Participating Cumulative Preferred Stock (to be effective upon or immediately prior to the closing of this offering)
 4.1**    Specimen Stock Certificate evidencing the shares of common stock
 4.2**    Form of Shareholders Rights Agreement between Harvard Apparatus Regenerative Technology, Inc., and Registrar and Transfer Company, as Rights Agent (to be effective upon or immediately prior to the closing of this offering)
 5.1**    Opinion of Burns & Levinson LLP
10.1**    Form of Separation and Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.2**    Form of Transition Services Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.3**    Form of Tax Matters Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.4**#   Form of Employment Agreement between Harvard Apparatus Regenerative Technology, Inc. and David Green
10.5**#    Form of Employment Agreement between Harvard Apparatus Regenerative Technology, Inc. and Thomas McNaughton
10.6**     Form of Director and Officer Indemnification Agreement
10.7**     Form of 2013 Equity Incentive Plan
10.8**     Form of Employee Stock Purchase Plan
10.9**     Form of Non-Qualified Stock Option Agreement
10.10**    Form of Incentive Stock Option Agreement
10.11**    Form of Non-Qualified Stock Option Agreement for executive officers
10.12**    Form of Non-Qualified Stock Option Agreement for directors
10.13**    Form of Deferred Stock Award Agreement
10.14**#   Director Compensation Arrangements
10.15†     Sublicense Agreement dated as of December 7, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc., and related Trademark License Agreement, dated December 19, 2002, by and between Harvard Bioscience, Inc. and President and Fellows of Harvard College.
10.16†     Form of Product Distribution Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.17†     Form of Intellectual Property Matters Agreement between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
10.18      Patent Rights Assignment dated December 21, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Dr. Paolo Macchiarini.
10.19†     Exclusive License Agreement dated August 6, 2009 by and between Harvard Apparatus Regenerative Technology, Inc. (as assignee of Harvard Bioscience, Inc.) and Sara Mantero and Maria Adelaide Asnaghi.
10.20      Sponsored Research Agreement dated August 5, 2009 by and among Harvard Apparatus Regenerative Technology, Inc. (as assignee of Harvard Bioscience, Inc.), Sara Mantero, Maria Adelaide Asnaghi, and Department of Bioengineering of the Politecnico Di Milano
10.21      Novel Surgery Agreement dated as of May 21, 2012 between Harvard Apparatus Regenerative Technology, Inc. and State Budget Institution of Public Health Department Regional Clinical Hospital #1 and Vladimir Alekseevich Porhanov.


 
 

TABLE OF CONTENTS

 
10.22      Novel Surgery Agreement dated as of May 24, 2012 between Harvard Apparatus Regenerative Technology, Inc. and OSF Healthcare System, owner and operator of Saint Francis Medical Center and Children’s Hospital of Illinois, and Mark Holterman, M.D.
10.23**    Form of Sublease between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc.
21         Subsidiaries of the Registrant
23.1       Consent of KPMG LLP
23.2**     Consent of Burns & Levinson LLP (included in Exhibit 5.1)
24.1*      Power of Attorney (included on signature page)

* Previously filed.
** To be filed by amendment.
Confidential portions of this exhibit (indicated by asterisks) have been redacted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
# Management contract or compensatory plan or arrangement.


 

EXHIBIT 10.15

 

CONFIDENTIAL TREATMENT REQUESTED

 

The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934 as amended.

 

REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***].

 

SUBLicense Agreement

 

THIS SUBLICENSE AGREEMENT is effective as of the 7 th day of December, 2012 (the “Agreement”), by and between Harvard Bioscience, Inc. (hereinafter called LICENSOR), a corporation organized and existing under the laws of Delaware, having a principal place of business at 84 October Hill Road, Holliston, MA 01746, and Harvard Apparatus Regenerative Technology, Inc. (hereinafter, including its subsidiaries and divisions, called LICENSEE), a corporation organized and existing under the laws of Delaware, having a principal place of business at 84 October Hill Road, Holliston, MA 01746.

 

WHEREAS, LICENSOR previously entered a Trademark License Agreement with the President and Fellows of Harvard College (“Harvard”), dated December 19, 2002 (the “Harvard License Agreement”, attached as Exhibit A hereto), which agreement, among other things, authorized LICENSOR to use and to sublicense the mark HARVARD APPARATUS (the “Mark”); and

 

WHEREAS, LICENSEE is desirous of using the Mark in connection with its business in the Field as further defined below; and

 

WHEREAS, LICENSOR is willing to sublicense to LICENSEE the Mark for the purposes outlined in this Agreement and subject to the terms and conditions of this Agreement;

 

NOW, THEREFORE, in consideration of the foregoing and of the mutual promises hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

 

1. GRANT OF LICENSE; LIMITATIONS

 

Subject to the terms of this Agreement, and for good and valuable consideration, the receipt and sufficiency of which are acknowledged, LICENSOR hereby grants to LICENSEE a perpetual, worldwide, royalty-free, exclusive (except as to LICENSOR and its subsidiaries as provided in more detail in Section 3), nontransferable, non-sublicensable (except as provided herein), license to use the Mark in the Field (as defined in Section 2, below), provided that such Mark is used only (i) as “ Harvard Apparatus Regenerative Technology,” (the “HART Mark”) (ii) as @harvardapparatusregen.com or @harvardapparatusregenerativetechnology.com for use in its domain names and email addresses, and (iii) other uses that the LICENSOR may consent to in writing from time to time. For purposes of this Agreement, the term “use” shall include the use of the HART Mark: (i) in LICENSEE’S company name, Harvard Apparatus Regenerative Technology , and in the company name of its subsidiaries and divisions (provided notwithstanding anything to the contrary contained herein, LICENSEE shall not use just the Mark alone in its company name or that of its subsidiaries and divisions); (ii) in all communications in its corporate capacity; (iii) in the sale or offering for sale of Licensed Goods and Services (as defined in Section 2, below) in the HART Field (as defined below in Section 3); and (iv) any other uses permitted under the Harvard License Agreement (subject to the limitations set forth herein, including, without limitation, this Section and Section 3).

 

1
 

 

2. FIELD OF AUTHORIZED USE; LICENSED GOODS AND SERVICES

 

For purposes of this Agreement, “Field” shall mean the Field as defined in the Harvard License Agreement, and “Licensed Goods and Services” shall mean and refer exclusively to products and services related to: (a) research and development efforts in the Field; (b) and clinical and commercial applications in the Field, including the manufacturing, development, testing, promotion, advertisement, sale, offering for sale and/or licensing (if appropriate) of goods and services in the Field. Licensed Goods and Services shall be limited to goods and services directed exclusively to the Field.

 

3. LICENSOR’S CONTINUED USE; ADDITIONAL RESTRICTIONS ON LICENSOR AND LICENSEE

 

LICENSOR shall have the continued right, during the Term and thereafter, to use the Mark HARVARD APPARATUS, provided, however that LICENSOR: (a) shall not use the HART Mark; and (b) shall not directly or indirectly use, or allow the use of, the Mark together with any other words or phrases that are substantially similar to, or would create a likelihood of confusion with, either (i) the HART Mark or (ii) the LICENSEE’S use of the HART Mark with respect to the HART Business (as defined below) provided such use complies with the terms and conditions hereof and of any other written agreement between the LICENSOR and LICENSEE.

 

Provided further, and notwithstanding anything to the contrary contained herein, except as may be otherwise permitted in accordance with any other written agreement between the LICENSOR and LICENSEE, at all times that LICENSEE is not a wholly-owned subsidiary of LICENSOR:

 

(i) without the prior written consent of the LICENSEE, the LICENSOR shall not at any time during the term of this Agreement, directly or indirectly use, or allow the use of, the Mark in any manner that pertains to the commercialization, manufacture and sale of products intended for use with respect to or on humans or their cells, tissue or organs, as part of a procedure that involves an injection, implant or transplant into a human (the “HART Field”, which for avoidance of any doubt includes the development of pumps for human clinical injections and bioreactors and scaffolds for regenerating human organs and tissues and products for use on humans (or on human cells, tissue or organs) as part of a procedure that involves an injection, implant or transplant into a human), or development thereof, as well as any natural area of expansion practiced by companies comparable to HART within the HART Field (the “HART Business”, and which for the avoidance of any doubt shall be subject to the exclusive ownership and right of HART and not HBIO or its subsidiaries), and

 

(ii) without the prior written consent of the LICENSOR, the LICENSEE shall not at any time during the term of this Agreement, directly or indirectly use, or allow the use of, the Mark or the HART Mark in the Field unrelated to the HART Business, or in a manner that creates, or would create a likelihood of, confusion with the LICENSOR use of the Mark in the Field unrelated to the HART Business.

 

2
 

 

4. OWNERSHIP AND OF MARK; LICENSE EXCLUSIONS

 

LICENSEE acknowledges that Harvard is the exclusive owner of the mark HARVARD and that LICENSOR is the exclusive (as between LICENSOR and LICENSEE) licensee of the right to use the name and mark HARVARD BIOSCIENCE. LICENSOR represents and warrants that it has the authority to grant the rights to LICENSEE hereunder in compliance all applicable laws and regulations, and that is shall use its best efforts to cause Harvard to maintain the registration of the Mark with the United States Patent and Trademark Office and any other jurisdictions where Harvard has registered the Mark (at the request of LICENSOR or otherwise), and if requested by LICENSEE, shall, at LICENSEE’S expense, request and use its best efforts to cause Harvard to register the MARK worldwide, or any portion thereof, in accordance with Section 5 of the Harvard License Agreement. No right or license is hereby granted to LICENSEE to use any mark other than HARVARD APPARATUS. LICENSEE agrees that it will do nothing inconsistent with the rights of Harvard or LICENSOR in the Mark or other Harvard marks noted above, and that all use of the Mark by LICENSEE shall inure to the benefit of and be on behalf of Harvard. LICENSEE agrees to assist LICENSOR, at LICENSOR’s expense, in recording this Agreement with appropriate government authorities, if necessary. LICENSEE agrees that nothing in this Agreement shall give LICENSEE any right, title or interest in the Mark other than the right to use the Mark in accordance with this Agreement. LICENSEE agrees that, except as may be required to protect and enforce its rights under this Agreement or any other agreement entered into between LICENSOR and LICENSEE, LICENSEE shall not challenge Harvard’s ownership of all right, title and interest in the Mark or the validity of the Mark, nor challenge LICENSOR’s rights to use the Mark under the Harvard License Agreement. LICENSOR acknowledges LICENSEE’S rights to use the Mark in accordance with the terms of this Agreement and will not take any action inconsistent with the rights granted to LICENSEE hereunder or any other agreement entered into between LICENSOR and LICENSEE in the future that contains provisions relating to the Mark and use thereof.

 

5. JOINDER

 

LICENSEE agrees to be bound by the terms of the Harvard License Agreement that are applicable to it as a sublicensee of the Mark and acknowledges that the terms and conditions of such Harvard License Agreement shall apply to it as if it was the licensee thereunder.

 

6. QUALITY STANDARDS AND QUALITY MAINTENANCE

 

For the avoidance of any doubt, LICENSEE agrees to comply with Section 6 of the Harvard License Agreement as if such Section applied to the Licensed Goods and Services.

 

7. FORM OF USE; ATTRIBUTION

 

For the avoidance of any doubt, LICENSEE agrees to comply with Section 3(b) of the Harvard License Agreement with respect to its use of the Mark.

 

8. INFRINGEMENT PROCEEDINGS AND INDEMNITY

 

For the avoidance of any doubt, the LICENSEE and LICENSOR agree that the LICENSEE shall have the same rights of LICENSOR under Section 7 of the Harvard License Agreement with respect potential actions and activities of unauthorized use of the Mark.

 

LICENSEE shall indemnify Harvard in accordance with Section 8 (erroneously labeled as a second Section 2) of the Harvard License Agreement. LICENSEE shall indemnify, defend and hold harmless LICENSOR from all third party claims, actions and proceedings arising out of or related to LICENSEE’s use of the Marks or LICENSEE’s breach of any of its obligations under this Agreement. Each of LICENSOR and LICENSEE shall indemnify, defend and hold harmless the other party from all third party claims, actions and proceedings arising out of or related to such indemnifying party’s use of the Mark (or Licensed Mark or Licensed Product Names, as defined in the Harvard License Agreement) or from such indemnifying party’s breach of any of its obligations under this Agreement. The parties’ obligation to indemnify is subject to the conditions that the party with the obligation to indemnify (“Indemnifying Party”) is given prompt notice of any such claims and is given primary control of and all reasonably requested assistance (at the other party’s cost) for the defense of such claims (with counsel reasonably satisfactory to the party being indemnified (“Indemnified Party”)), provided, however, that any delay in notification shall not relieve the Indemnifying Party of its obligations hereunder except to the extent that the delay materially impairs its ability to indemnify. The Indemnifying Party shall not enter into or acquiesce to any settlement containing any admission of or stipulation to any guilt, fault, liability or wrongdoing on the part of the Indemnified Party or which would otherwise adversely affect the Indemnified Party without the Indemnified Party’s prior written consent, which consent shall not be unreasonably withheld or delayed. The Indemnifying Party shall keep the Indemnified Party advised of the status of the claims and the defense thereof and shall consider in good faith recommendations made by the Indemnified Party with respect thereto.

 

3
 

 

9. TERM

 

This Agreement shall continue in force and effect unless and until the Harvard License Agreement is terminated by Harvard in accordance with Section 10 thereof or unless sooner terminated as provided for in Section 10 below.

 

10. TERMINATION

 

LICENSEE may terminate this Agreement, at any time in its sole discretion, upon at least thirty (30) days’ prior written notice to LICENSOR. Except as provided in this Section 10 below, the LICENSOR shall have no right to terminate this Agreement. LICENSOR may terminate this Agreement for material breach of this Agreement by LICENSEE, provided that LICENSEE shall have at least sixty (60) days following its receipt of written notice specifying the details of such breach from LICENSOR to use reasonable business practices to cure such material breach and provided further that in the event the breach involves LICENSEE’S failure to maintain the quality of Licensed Goods and Services, it shall have one hundred twenty (120) days written notice to use reasonable business practices to cure. The cure of any material breach by LICENSEE of this Agreement shall not require the recall or return of any written materials, packaging or product which have been sent to third parties, including, without limitation, customers of LICENSEE, prior to LICENSOR'S notice of breach. The following shall not constitute a material breach of this Agreement by LICENSEE: (1) the failure to notify LICENSOR of a third party's unauthorized use of the Mark; and (2) the failure to notify LICENSOR of a change of address pursuant to Section 16 hereof. If the parties disagree as to whether a material breach has been cured, the matter shall be submitted to binding arbitration in accordance with Section 18 of this Agreement, in which event this Agreement shall not be terminated unless a final decision is rendered in favor of LICENSOR. In the event of such arbitration, LICENSEE shall cooperate with LICENSOR in submitting the matter to the arbitrator(s) as speedily as possible.

 

Notwithstanding the provisions of Section 10(a) or (d) of the Harvard License Agreement, the LICENSOR shall not terminate the Harvard License Agreement without the prior written consent of the LICENSEE. In addition, LICENSOR shall at all times and in all respects comply with the Harvard License Agreement and shall take and perform all measures necessary to ensure that the Harvard License Agreement is not terminated by Harvard at any time, including without limitation steps to cure any alleged breach in accordance with Section 11 of the Harvard License Agreement. If at any time the LICENSOR receives any notice or correspondence from Harvard regarding a breach or termination of the Harvard License Agreement, the LICENSOR shall promptly notify, and provide copies of such correspondence to, the LICENSEE.

 

4
 

 

11. EFFECT OF TERMINATION

 

Upon termination of this Agreement, LICENSEE shall, within twelve (12) months from the effective date of the termination, discontinue all use of the Mark and any term confusingly similar thereto, and to delete the same from its corporate or business name, cooperate with LICENSOR or its appointed agent to apply to the appropriate authorities to cancel recording of this Agreement from all government records, and to destroy all printed materials bearing the Mark, other than corporate records.

 

12. SUCCESSORS AND ASSIGNS

 

Neither this Agreement or the Mark may be assigned by LICENSEE, except that LICENSEE may assign this Agreement in connection with a sale of all or substantially all the business and goodwill associated with the products sold under the Mark. Said sale may be in the form of an asset or stock sale or any combination thereof. Notwithstanding the above, this section shall not be deemed to prohibit, or require any consent with respect to, any change in control of the LICENSOR or LICENSEE by way of an entity acquiring the outstanding stock of the LICENSOR or LICENSEE. LICENSEE may also pledge or hypothecate this Agreement, but no third party may use the Mark except in compliance with this Agreement. Subject to the foregoing, this Agreement is binding upon the parties, their successors, assigns, heirs, executors and administrators.

 

13. INTERPRETATION OF AGREEMENT

 

It is agreed that this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the Commonwealth of Massachusetts, United States of America, without regard to its conflict of law or other principles that would result in the application of any laws other than the internal laws of the Commonwealth of Massachusetts.

 

14. DISCLOSURE.

 

The parties will be permitted to disclose in writing the fact, but not the material terms, of this Agreement to the extent necessary to comply with applicable law and generally accepted accounting principles. The form of any such written disclosure by either party must be submitted to the other party hereto for prior written approval, which approval shall not be unreasonably withheld, delayed or conditioned. If no, written response is received within 10 business days, the form of disclosure will be deemed approved. 

 

15. NO FRANCHISE OR AGENCY.

 

Both parties agree that this Agreement is a license only, and neither party intends to create any franchise relationship hereby. LICENSEE shall continue to have full, responsibility for and control over all operations of its business, and the provisions relating to the nature and quality of goods or services sold by LICENSEE and the manner in which LICENSEE may display the Mark are included herein solely for the purpose of protecting the integrity, reputation and goodwill associated with the Mark. Nothing herein shall be construed as placing the parties in the relationship of franchisor or franchisee, employer or employee, or principal or agent. Neither party shall have the power to obligate or bind the other in any manner except as otherwise expressly provided by this Agreement.

 

16. NOTICES, TIMING AND FORM .

 

All written notices (or other communications) relating to this Agreement shall be deemed to be sufficiently given when sent by United States Postal Service - certified mail with signed receipt (or otherwise provably received by signed receipt from the recipient) addressed to the party for whom intended at the following addresses, or at the last known address. Each party shall promptly notify the other party in writing of any change of the address to which notices under this Section should be sent. The effective date of such notice shall be the date the notice is received. In addition to the required physical delivery of notices set forth herein, each party shall also send copies of notices via e-mail if an e-mail address is provided below.  However, in no event will notice be deemed delivered or received by a party if sent solely via e-mail.

 

5
 

 

(a) To LICENSOR :
     
    Harvard Bioscience, Inc.
    Attention: Chane Graziano, Chief Executive Officer
    84 October Hill Road
    Holliston, MA 01746
    Email: cgraziano@harvardbioscience.com

  

(b) To LICENSEE :
     
    Harvard Apparatus Regenerative Technology, Inc.
    Attention: David Green, President
    84 October Hill Road
    Holliston, MA 01746
    Email: dgreen@harvardbioscience.com

 

17. PRIOR AGREEMENTS, AMENDMENTS, SEVERABILITY .

 

This Agreement is the entire agreement of the parties, and supersedes all prior oral or written agreements or understandings of the parties with respect to the subject matter hereof. This Agreement may be amended only by a writing signed by both parties hereto. If any provision of this Agreement is held by a court of competent jurisdiction to be invalid, void or unenforceable, the remaining provisions shall nevertheless continue in full force without being impaired or invalidated in any way.

 

18. DISPUTE RESOLUTION.

 

Any dispute arising under or involving this Agreement shall be submitted to binding arbitration before JAMS, The Resolution Experts, or its successor (“ JAMS ”) in Boston, Massachusetts, or, if JAMS is no longer in business, before a mutually acceptable arbitrator or arbitration service in Boston, or, failing such agreement, before the American Arbitration Association in Boston. Any such arbitration shall commence upon written demand of one of the parties, and shall be determined by a single arbitrator sitting in accordance with the Rules of Commercial Arbitration of the American Arbitration Association then in force at its office in Boston, Massachusetts. The decision of the arbitrator shall be final and binding. The expense of the arbitration shall be shared equally by the parties and each party shall bear its own attorneys’ fees, unless the arbitration award states that the expenses and fees shall be otherwise assessed (which t he arbitrators may do in their discretion) and provided further , however, the parties agree that the prevailing party shall be entitled to, and the arbitrator shall award to the prevailing party, its attorneys’ fees, costs and expenses in the event such party completely prevails or prevails in all material respects in the arbitration decision as determined by the arbitrator. Any such arbitration shall take place in or near Boston, Massachusetts.

 

[Remainder of Page Intentionally Left Blank]

 

6
 

 

IN WITNESS WHEREOF, the parties hereto have caused this Sublicense Agreement to be executed as of the day and year first above written.

 

LICENSOR:  
   
Harvard Bioscience, Inc.  
   
By: /s/ Chane Graziano  
   
Name: Chane Graziano  
   
Title: Chief Executive Officer  

 

LICENSEE:  
   
Harvard Apparatus Regenerative Technology, Inc.  
   
By: /s/ David Green  
   
Name: David Green  
   
Title: President  

 

 
 

 

Exhibit A

 

Harvard License Agreement

 

(see attached)

 

 
 

 

TRADEMARK LICENSE AGREEMENT

 

Effective this 19th day of December 2002, President and Fellows of Harvard College (“Harvard”), a charitable, non-profit corporation organized under the laws of the Commonwealth of Massachusetts, having its principal place of business in Cambridge, Massachusetts, and Harvard Bioscience, Inc. (“Harvard Bioscience”), a corporation organized under the laws of the State of Delaware, having its principal place of business in Holliston, Massachusetts, hereby agree as follows:

 

1.           Background .  Harvard is the oldest university in the United States and comprises several schools, including an undergraduate college, as well as the Medical, Dental, Public Health, Law, Divinity, Business, Design, and Education schools, the Graduate School of Arts and Sciences, and the John F. Kennedy School of Government.  The Harvard Medical School was established in 1782.  For more than 200 years, the Harvard Medical School, together with its affiliated hospitals, has been widely regarded as a preeminent institution for medical education, health care, and research.

 

Harvard is the owner of its famous HARVARD name and mark and holds numerous United States federal trademark registrations and international trademark registrations for the HARVARD name and mark and other HARVARD-formative marks.  Throughout its history, Harvard has used the HARVARD name and mark to identify its educational, medical, health care, and research services, purposes and mission.

 

Harvard Bioscience is a corporation engaged in the business of designing, manufacturing, selling and/or offering for sale products and services for scientific research, industrial applications and OEM applications.  Harvard Bioscience was formerly known as the Harvard Apparatus Company and as Harvard Apparatus, Inc., and is the successor to a corporation formed in or about 1903 by Dr. William T. Porter, a professor at the Harvard Medical School.

 

Currently pending in the United States District Court, District of Massachusetts, is Civil Action No. 00-12625, President and Fellows of Harvard College v. Harvard Bioscience, Inc., in which the parties disagree whether the uses by Harvard Bioscience of HARVARD-formative marks are lawful. The parties agree that their mutual interest calls for a settlement of this litigation on the terms set out below.

 

The parties acknowledge that a license, implied or otherwise, from Harvard to Harvard Bioscience has been in effect since 1903, under which Harvard Bioscience has used the mark HARVARD APPARATUS and certain HARVARD-formative product names.  The parties wish to confirm that license and to agree to the following terms by which Harvard Bioscience may continue those and other uses of the HARVARD name and mark, as set forth in this Trademark License Agreement (this “Agreement”).

 

One purpose of this Agreement is to set forth the distinct ways in which Harvard Bioscience may use the marks HARVARD APPARATUS and HARVARD BIOSCIENCE, respectively.  As the paragraphs below provide, Harvard Bioscience may use HARVARDBIOSCIENCE only as its company name, and for communications in its corporate capacity, for example, with its former, current and prospective investors and employees, its sources of finance, its service providers, its vendors, or government agencies.  By contrast, HARVARD APPARATUS may be used, in addition to the above uses, in connection with the sale of products and services, for example, on products, catalog covers and in communications with customers. The parties understand that in some instances no bright line separates the two respective uses and that Harvard Bioscience may, due either to unavoidable circumstances or inadvertence, use HARVARD BIOSCIENCE in a context where only the use of HARVARD APPARATUS is appropriate under this Agreement, or vice versa.  While such misuse is not a basis for termination of this Agreement, Harvard Bioscience will at all times make every effort to use the licensed marks in compliance with those paragraphs below that expressly govern Harvard Bioscience’s use of those marks.

 

2.           Grant of License .  For good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Harvard hereby grants to Harvard Bioscience, its affiliates and divisions, a worldwide, royalty- free, nonexclusive, license to use the HARVARD name and mark only in the form of HARVARD APPARATUS and/or HARVARD BIOSCIENCE (together, the “Licensed Marks”) and in the other forms provided below, and only in accordance with this Agreement, provided that the following conditions are satisfied :

 

1
 

 

a.          Harvard Bioscience may use HARVARD BIOSCIENCE only as its company name and only in connection with the business of designing, manufacturing, selling and/or offering for sale products and services for scientific research, industrial and OEM applications. Such applications include, by way of example, usages related to the physiological, pharmaceutical, biological, chemical, physical, environmental, food and beverage and medical sciences, and those products and services within Harvard Bioscience’s natural area of expansion as practiced by companies comparable to Harvard Bioscience (the “Field”).  Harvard Bioscience may use HARVARD BIOSCIENCE only for purposes of communications with former, current or prospective investors and employees, sources of finance, its service providers, its vendors, or government agencies, and others in its corporate capacity, including, for example, on stationery for correspondence in its corporate capacity or directed to actual or prospective investors and government agencies, and on business cards; annual reports and other materials provided to investors; filings with the Securities Exchange Commission and other regulatory agencies; deeds and/or leases of real property, loan instruments, contracts, and any other document or medium in which the legal name of the corporation is required to be used; and press releases and other communications with print, broadcast or other news media relating to corporate acquisitions, investments, financing and other corporate matters. Harvard Bioscience may similarly use HARVARD BIOSCIENCE as part of the identification of its current and future divisions, affiliates and related companies, such as “Warner Instruments, a Harvard Bioscience Company,” or “Warner Instruments, a Division of Harvard Bioscience, Inc.” Harvard Bioscience may maintain a website at its existing Internet address, www.harvardbioscience.com, all content of which, whether directed to customers or to investors, shall be subject to this Agreement.  Harvard Bioscience may not, however, use HARVARD BIOSCIENCE in connection with the sale or offering for sale of goods or services or in communications with customers or the general public unless such communication is for corporate purposes not relating to sales of products or services.  For example, Harvard Bioscience may not use HARVARD BIOSCIENCE on catalogs, advertisements, marketing or promotional materials, products, packaging, trade show banners, stationery for use in correspondence with customers, on sales invoices, press releases or other communications relating to its sales of products, except as provided in paragraphs 2(a) and 2(b).

 

b.          Harvard Bioscience may use HARVARD APPARATUS in connection with the sale or offering for sale of products and services in the Field (the “Licensed Goods and Services”). When using HARVARD APPARATUS in this manner, Harvard Bioscience may refer to “Harvard Bioscience, Inc.” to indicate the legal name of the corporation responsible for the offering.  Such reference to “Harvard Bioscience, Inc.” may appear up to several times in any multi-page publication, such as a catalog or brochure, and must be inconspicuous relative to the use therein of HARVARD APPARATUS.  For example, in a catalog or brochure, a reference to “Harvard Bioscience, Inc.” may appear only in type not larger or more prominent than that used for the general text or advertising copy within which “Harvard Bioscience” is proposed to appear.  Harvard Bioscience may also use HARVARD APPARATUS in all of the ways it may use HARVARD BIOSCIENCE under Paragraph 2(a).

 

c.          Harvard Bioscience may use the HARVARD name and mark for the following products, as part of their product names, which have previously been in use (“Licensed Product Names”): Harvard Pump, Harvard 22 (and other numbers), Harvard Syringe Pump, Harvard PHD Pump, Harvard PHD 2000 Syringe Pump, Harvard Peristaltic Pump, Harvard Mechanical Syringe Pump, Harvard Mechanical Peristaltic Pump, Harvard Shuttle Pump, Harvard Ventilator, Harvard Spirometer, Harvard Stimulator, Harvard Biograph, Harvard Chart Recorder, Harvard Oscillograph, Harvard Electrophysiological Teaching Unit, Harvard Kymograph, Harvard Indirect Rat Tail Blood Pressure System, Harvard Pulsatile Blood Pumps, Harvard Microdialysis Probes, Harvard Microelectrode Puller, Harvard Clark Capillary Glass, Harvard Thermocirculator, Harvard Stronghold, Harvard CPK, Harvard Clamps, and Harvard Connectors.  Harvard Bioscience may not use the HARVARD name and mark, other than in the form of HARVARD APPARATUS, as part of any product name not on the aforementioned list unless Harvard Bioscience obtains the prior written approval to do so from Harvard’s Office of Technology and Trademark Licensing.  Licensed Product Names shall be used only in their entirety and only in the exact form in which they appear on this list (for example, “Harvard Pump” or “Harvard Syringe Pump” or “Harvard Mechanical Syringe Pump”), except that a Licensed Product Name may be followed by numbers or letters denoting a new or updated version or series (for example, “Harvard Pump 2” or “Harvard Pump 2003”), or modified by a descriptive term (for example, “Harvard 2 Dual Syringe Pump” or “Harvard Mechanical Compact Syringe Pump.) The use by Harvard Bioscience of the Licensed Product Names shall conform to the font limitations of paragraph 3(a). Harvard Bioscience shall not otherwise use the HARVARD name and mark, alone or in combination with words other than APPARATUS or BIOSCIENCE.

 

2
 

 

d.          Harvard Bioscience may include in its catalogs, its website, and in other materials a statement that Harvard Bioscience is using the Licensed Marks and Licensed Product Names pursuant to this Agreement, in substantially the following form: “HARVARD is a registered trademark of Harvard University.  The mark HARVARD APPARATUS [or HARVARD BIOSCIENCE] [or HARVARD as part of a product name] is being used pursuant to a license agreement between Harvard University and Harvard Bioscience, Inc.”  If Harvard Bioscience wishes to use such a statement in any other form, Harvard Bioscience shall submit the art layout and placement information for such a statement to Harvard for prior written approval, which approval shall not be unreasonably withheld, before the statement may be used in any given medium (e.g., catalog, advertisement, website).  Once approval has been obtained for use in a given medium, Harvard Bioscience may continue such use in that medium in the approved format for so long as this Agreement remains in force and effect.  Once a format is submitted to Harvard for approval Harvard will have 10 business days to approve or disapprove the format.  If no written response is received within 10 business days, the format will be deemed approved

 

e.          Harvard Bioscience shall not represent or imply, in its catalogs, advertisements or otherwise, that it is affiliated with any educational or research institution or enterprise, except that, if Harvard Bioscience enters into an agreement or business relationship with any educational or research institution, including but not limited to the licensing of technology, joint research and development, or product validation or testing, Harvard Bioscience may make truthful statements regarding such agreement.  Harvard Bioscience shall not, however, be prohibited from making truthful statements regarding its history, including its connection with the Harvard Apparatus Company founded by Professor William T. Porter and its use of the mark HARVARD APPARATUS prior to this Agreement.

 

f.          Within 18 months of the date of this Agreement, Harvard Bioscience will cease to use or distribute any catalogs, stationery, labels, business cards or other materials that do not comply with paragraphs 2(a)-(d) hereof. [***]

 

g.          So long as this Agreement remains in effect, Harvard agrees that it will not use the mark HARVARD APPARATUS, that it will not use the mark HARVARD BIOSCIENCE other than in connection with bioscience-related activities or offerings at Harvard, and that it will not license or otherwise authorize any third party to use the HARVARD name and mark in the form of either of the Licensed Marks.

 

h.          For purposes of this paragraph 2, “affiliates” shall mean any members of Harvard Bioscience’s “affiliated group” as defined in Internal Revenue Code § 1504.

 

3.        Form of Use .

 

a.          Harvard Bioscience agrees to use the Licensed Mark HARVARD BIOSCIENCE solely in a form wherein (i) all letters are in the same font and color (ii) all letters of the word BIOSCIENCE are in a font size no smaller than ½ the font size of the word HARVARD; (iii) the word BIOSCIENCE always follows the word HARVARD immediately (either immediately after or immediately below); and (iv) neither the word HARVARD nor the mark HARVARD BIOSCIENCE appears in any of the following fonts:  Bembo, Bodoni, Caslon, Centaur, Century Schoolbook, Garamond, Goudy, ITC New Baskerville, ITC Galliard, Linotype Didot, Minion, New Times Roman, Palatino (collectively, the “Representative Serif Fonts”), or any font similar thereto, or in, surrounded, accentuated or bordered by the color crimson, [***]

 

b.          Harvard Bioscience agrees to use the Licensed Mark HARVARD APPARATUS solely in a form wherein (i) all the letters of APPARATUS are in a font size no smaller than ½ the font size of the letters HARVARD; (ii) the word APPARATUS always follows the word HARVARD immediately (either immediately after or immediately below); and (iii) neither the word HARVARD nor the mark HARVARD APPARATUS appears in any of the Representative Serif Fonts or any font similar thereto, or in, surrounded, accentuated or bordered by the color crimson.  Nothing in this Agreement shall prevent Harvard Bioscience from using the color red in connection with or for the Licensed Mark HARVARD APPARATUS.

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

3
 

 

c.          Harvard Bioscience agrees to use the Licensed Product Names solely in a form wherein (i) all letters are in the same font, color and point size; (ii) the word HARVARD is not presented more prominently than the other element or elements of the product name; and (iii) neither the word HARVARD nor any other element or elements of the product name appear in any of the Representative Serif Fonts, or any fonts similar thereto (except that such word or elements may appear in any such font within a general text or advertising copy printed entirely in that font), or in, surrounded, accentuated or bordered by the color crimson.

 

4.           Term of the License .  This Agreement shall continue in effect unless and until it is terminated by one of the parties in accordance with paragraph 10 hereof.

 

5.           Ownership of Marks .  Harvard warrants that it has the authority to grant the rights hereunder and that such grant is in compliance with applicable law. Harvard Bioscience acknowledges Harvard’s ownership of the HARVARD name and mark and agrees that it will not do anything inconsistent with such ownership. Harvard acknowledges Harvard Bioscience’s rights to use the Licensed Marks and Licensed Product Names as set forth in this Agreement and agrees that it will not do anything inconsistent with such rights. All use of the Licensed Marks and Licensed Product Names by Harvard Bioscience shall inure to the benefit of and be on behalf of Harvard.  Harvard Bioscience hereby transfers to Harvard any right, title, interest, and goodwill, if any, in all marks containing the word HARVARD, except for Harvard Bioscience’s right to use the Licensed Marks and Licensed Product Names under this  Agreement.  Harvard Bioscience agrees that nothing in this Agreement shall give Harvard Bioscience any right, title or interest in the HARVARD name and mark other than the right to use the Licensed Marks and Licensed Product Names in accordance with this Agreement.  Harvard shall have the sole right, but not obligation, to register the marks HARVARD APPARATUS and HARVARD BIOSCIENCE worldwide at Harvard’s expense, or shall do so upon request by Harvard Bioscience at Harvard Bioscience’s expense.  Upon request by and at the expense of Harvard Bioscience, Harvard shall make reasonable efforts to register the Licensed Marks in any country so requested by Harvard Bioscience.

 

6.           Quality Standards and Maintenance .  Harvard Bioscience agrees that the quality of all of the Licensed Goods and Services will be maintained at a commercially reasonable level and will comply with the requirements of any federal, state and other governmental regulatory agencies responsible for assuring the quality and fitness of such products. The parties agree that, without limitation, the quality of Licensed Goods and Services as of the date of this Agreement is at a commercially reasonable level of quality.  Further, and upon reasonable notice to Harvard Bioscience, which shall not be less than 10 days, Harvard shall have the right, at its own expense and no more than once in a calendar year, to conduct at Harvard Bioscience’s facilities an examination of specimens of its use of the Licensed Marks and of products manufactured by or for it, and to obtain from Harvard Bioscience information and documentation, as would enable Harvard to determine that the quality of the Licensed Goods and Services provided by Harvard Bioscience is maintained in accordance with this paragraph throughout the term of this Agreement.

 

7.           Unauthorized Use by Third Parties of the HARVARD Name and Mark .  Harvard Bioscience may notify Harvard in writing of any unauthorized use of the HARVARD name and mark by others engaged in the Field in the United States.  Harvard has the right to bring, defend, resolve, and control, at its expense, any and all claims and disputes based on unauthorized use of the HARVARD name and mark.  In the event that Harvard does not pursue judicial relief against any third party for any claim of unfair competition or false designation of origin that may cause confusion, mistake or deception with respect to Harvard Bioscience’s use of the Licensed Marks for the Licensed Goods and Services within 120 days after receiving notice from Harvard Bioscience of such a claim, Harvard Bioscience, in its sole discretion, may bring an action directly, at its own expense.  Any damages, attorney fees, or costs recovered by Harvard Bioscience in such action shall be retained by Harvard Bioscience.  Harvard and Harvard Bioscience shall cooperate in good faith with each other in connection with prosecution of claims by either party against third parties for any claim of trademark infringement or for any claim of unfair competition and false designation of origin that may cause confusion, mistake or deception with respect to Harvard Bioscience’s use of the Licensed Marks for the Licensed Goods.

 

8.           Indemnity . Harvard Bioscience shall indemnify Harvard for all claims arising from Harvard Bioscience’s use of the Licensed Marks or Licensed Product Names or from any acts, omissions or statements by Harvard Bioscience.

 

4
 

 

9.           Non-Assignment, Sublicenses by Harvard Bioscience .  Neither this Agreement nor the Licensed Marks or Licensed Product Names may be assigned by Harvard Bioscience, except that Harvard Bioscience may assign this Agreement in connection with a sale of all or substantially all the business and goodwill associated with the products sold under the HARVARD APPARATUS mark.  Said sale may be in the form of an asset or stock sale or any combination thereof.  Harvard Bioscience may pledge or hypothecate this Agreement, but no third party may use the Licensed Marks or the Licensed Product names except in compliance with this Agreement. Subject to the foregoing, this Agreement is binding upon the parties, their successors, assigns, heirs, executors and administrators.  Notwithstanding any provision of this Agreement, Harvard Bioscience may not enter into any transaction that would result in more than one person or entity purporting to have rights to use the mark HARVARD BIOSCIENCE. Harvard Bioscience may not sublicense its right to use the mark HARVARD BIOSCIENCE.  Harvard Bioscience may sublicense its right to use the mark HARVARD APPARATUS under this Agreement to third parties solely for use within the Field, provided that any such sublicensee shall agree in writing to be bound by the terms of this Agreement and Harvard is promptly provided with a copy of the signed sublicense.

 

10.         Termination .

 

a.          Harvard Bioscience may terminate this Agreement immediately for any reason upon thirty (30) days written notice to Harvard.

 

b.          This Agreement shall terminate when Harvard Bioscience ceases to use both Licensed Marks for a period of twenty-four (24) consecutive months, or upon a liquidation or dissolution of Harvard Bioscience that results in the cessation of use of both Licensed Marks. Further, Harvard Bioscience’s right to use either of the Licensed Marks shall terminate when Harvard Bioscience ceases to use such Licensed Mark for a period of twenty-four (24) consecutive months.

 

c.          Harvard may terminate this Agreement (1) if any of Harvard Bioscience’s officers is convicted of a felony in connection with the operation of Harvard Bioscience’s business and such officer remains an officer more than 60 days after Harvard, in a written notice to Bioscience, cites such conviction as a basis for termination; or (2) for material breach of this Agreement, provided that, in the case of material breach, Harvard Bioscience shall have sixty (60) days written notice to use reasonable business practices to cure and provided further that in the event the breach involves Harvard Bioscience’s failure to maintain the quality of Licensed Goods and Services, it shall have one hundred twenty (120) days written notice to use reasonable business practices to cure. The cure of any material breach by Harvard Bioscience of this Agreement shall not require the recall or return of any written materials, packaging or product, which have been sent to third parties, including, without limitation, customers of Harvard Bioscience prior to Harvard’s notice of breach. The following shall not constitute material breach: (1) the failure to notify Harvard of a third party’s unauthorized use of the HARVARD name and mark pursuant to paragraph 7 hereof; and (2) the failure to notify Harvard of a change of address pursuant to paragraph 15 hereof.  If Harvard Bioscience fails to cure a material breach, this Agreement shall terminate on sixty (60) days further written notice              If the parties disagree as to whether a material breach has been cured, the matter shall be submitted to binding arbitration in accordance with paragraph 16 of this Agreement, in which event this Agreement shall not be terminated unless and until a final decision is rendered in favor of Harvard.  In the event of such arbitration, Harvard Bioscience shall cooperate with Harvard in submitting the matter to the arbitrator(s) as speedily as possible.

 

d.           [***]

 

11.           Phase-Out Upon Termination .  Upon termination of this Agreement, Harvard Bioscience shall, within twelve (12) months from the effective date of the termination, discontinue all use of the Licensed Marks and Licensed Product Names and any terms confusingly similar thereto, shall delete the same from its corporate or business name, and shall destroy all materials and papers, other than corporate records, upon which any Licensed Mark or Licensed Product Name appears.  Harvard Bioscience agrees that, within twelve (12) months of termination, all rights in the HARVARD name and mark and the associated goodwill shall be and remain the property of Harvard and that Harvard shall, no sooner than ten years after termination, have the right, unrestricted by this  Agreement, to license the HARVARD name and mark in the form of the Licensed Marks and Licensed Product Names.

 

12.           [***]

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

5
 

 

13.           Performance of Further Acts .  Harvard Bioscience agrees to perform all further acts and to execute and deliver any additional documents which may be reasonably required by Harvard to carry out the provisions of this Trademark Licensing Agreement, including acts to perfect trademark registrations or assignments in the name of Harvard.  In the event that Harvard notifies Harvard Bioscience in writing that a use of the Licensed Marks or Licensed Product Names does not comply with the provisions of this Agreement, Harvard Bioscience will correct such non-complying use with reasonable promptness and confirm as much in writing.

 

14.           No Franchise or Agency .  Both parties agree that this Agreement is a trademark /trade name license only, and neither party intends to create any franchise relationship hereby.  Harvard Bioscience shall continue to have full responsibility for and control over all operations of its business, and the provisions relating to the nature and quality of goods or services sold by Harvard Bioscience and the manner in which Harvard Bioscience may display the Licensed Marks and Licensed Product Names are included herein solely for the purpose of protecting the integrity, reputation and goodwill associated with the Licensed Marks and Licensed Product Names.  Nothing herein shall be construed as placing the parties in the relationship of franchisor or franchisee, employer or employee, or principal or agent.  Neither party shall have the power to obligate or bind the other in any manner except as otherwise expressly provided by this Agreement.

 

15.           Notices, Timing and Form .  All written notices (or other communications) relating to this Agreement shall be deemed to be sufficiently given when sent by United States Postal Service – certified mail with signed receipt (or otherwise provably received by signed receipt from the recipient) addressed to the party for whom intended at the following addresses, or at the last known address.  Each party shall promptly notify the other party in writing of any change of the address to which notices under this paragraph should be sent.  The effective date of such notice shall be the date the notice is received.

  

(a)                    To Harvard :

 

Harvard University
Office of the General Counsel
Holyoke Center, Suite 980
1350 Massachusetts Avenue
Cambridge, Massachusetts  02138-3834

and

Harvard University
Office of Technology & Trademark Licensing
Holyoke Center, Suite 727
1350 Massachusetts Avenue
Cambridge, Massachusetts  02138

and

Bromberg & Sunstein LLP
125 Summer Street
Boston, MA 02110

 

(b)                    To Harvard Bioscience :

 

President
Harvard Bioscience, Inc.
84 October Hill Road
Holliston, MA  01746

and

Goodwin Procter LLP
Exchange Place
Boston, MA 02109

and

 

6
 

 

Dwyer & Collora LLP
600 Atlantic Avenue
Boston, MA 02210

 

15.           Prior Agreements, Amendments, Severability .  This Agreement is the entire agreement of the parties, and supersedes all prior oral or written agreements or understandings of the parties with respect to the subject matter hereof.  This Agreement may be amended only by a writing signed by the party to be charged.  If any provision of this Agreement is held by a court of competent jurisdiction to be invalid, void or unenforceable, the remaining provisions shall nevertheless continue in full force without being impaired or invalidated in any way.

 

16.           Governing Law .  This Agreement shall be construed and enforced in accordance with the laws of the United States and the Commonwealth of Massachusetts.  Any dispute arising under or involving this Agreement shall be submitted to binding arbitration before JAMS/Endispute in Boston, Massachusetts, or, if JAMS/Endispute is no longer in business, before a mutually acceptable arbitrator or arbitration service in Boston, or, failing such agreement, before the American Arbitration Association in Boston.  Any such arbitration shall commence upon written demand of one of the parties, and shall be determined by a single arbitrator sitting in accordance with the Rules of Commercial Arbitration of the American Arbitration Association then in force at its office in Boston, Massachusetts.  The decision of the arbitrator shall be final and binding.  The expense of the arbitration shall be shared equally by the parties and each party shall bear its own attorneys fees, unless the arbitration award states that the expenses and fees shall be otherwise assessed.  Any such arbitration shall take place in or near Boston, Massachusetts.

 

IN WITNESS , the parties hereto have caused this Agreement to be executed in duplicate by their authorized officers whose names and signatures are set out below.

 

HARVARD:

 

  President and Fellows of Harvard College
   
Dated: December 19, 2002 /s/ Joyce Brinton 
  By: Joyce Brinton
  Director, Office of Technology and Trademark Licensing

 

Commonwealth of Massachusetts  
Middlesex, ss. County December 19, 2002

 

Then personally appeared the above-named Joyce Brinton, duly authorized Director of the Office of Technology and Trademark Licensing of the President and Fellows of Harvard College, and acknowledged the foregoing instrument to be her free act and deed, before me,

 

[Notary Seal] /s/ Jeremy R. Jenkins 
  Notary Public
  My commission expires: February 3, 2006

 

7
 

 

HARVARD BIOSCIENCE:

 

  Harvard Bioscience, Inc.
   
   
  /s/ David Green 
Dated:  December     , 2002 By:  David Green
  Title: President

 

Middlesex, ss.

 

Then personally appeared the above-named David Green, duly authorized President of Harvard Bioscience, Inc., and acknowledged the foregoing instrument to be his free act and deed, before me,

 

  /s/ Alexia Armstrong 
  Notary Public
  My commission expires: 9/11/09

 

8

 

 

EXHIBIT 10.16

 

CONFIDENTIAL TREATMENT REQUESTED

 

The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934 as amended.

 

REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***].

 

PRODUCT DISTRIBUTION AGREEMENT

 

BY AND BETWEEN

 

HARVARD BIOSCIENCE, INC.

 

AND

 

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

 

DATED AS OF [ ], 2013

 

1
 

 

PRODUCT DISTRIBUTION AGREEMENT

 

THIS PRODUCT DISTRIBUTION AGREEMENT dated as of [ ], 2013 (this “ Agreement ”), is entered into by and between HARVARD BIOSCIENCE, INC., a Delaware corporation (“ HBIO ”) and HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC ., a Delaware corporation (“ HART ”) (each, a “ Party ” and, collectively, the “ Parties ”).

 

RECITALS

 

WHEREAS, HBIO is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine;

 

WHEREAS, among its various business activities, HBIO operates various lines of business related to the development, manufacturing and marketing of apparatus and scientific instruments, including the Harvard Apparatus Research Business (as defined below) and the HART Business (as defined below);

 

WHEREAS, pursuant to the Separation and Distribution Agreement to be entered into by and between HBIO and HART, (the “ Separation and Distribution Agreement ”), the Parties have agreed to separate the HART Business from HBIO;

 

WHEREAS, it is the intent of the Parties, after giving effect to the transactions contemplated by the Separation and Distribution Agreement, for the Parties to act as distributors of certain of each other’s products subject to the limitations and other terms and conditions hereof;

 

WHEREAS, the Parties desire to enter into this Agreement to codify the arrangements whereby the Parties shall act as distributors of each other’s products;

 

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties hereby agree as follows. Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Separation and Distribution Agreement.

 

1.              Appointment of Distributors.

 

1.1.           By Hart . HART hereby appoints HBIO, and HBIO accepts such appointment, to be HART’s exclusive, independent, worldwide distributor for the resale of HART’s products that relate to any of HBIO’s business activities it conducts from time to time for all applications outside the HART Business, subject to the terms of any Third Party distribution agreements in effect on the Separation Date (as defined in the Separation and Distribution Agreement), and subject further to the non-competition covenants contained in Article IX of the Intellectual Property Matters Agreement.

 

1.2.           By HBIO . HBIO appoints HART, and HART accepts such appointment, to be HBIO’s exclusive, independent, worldwide distributor for the resale of HBIO’s products from its Harvard Apparatus Research Business for use in the HART Business, subject to the terms of any Third Party distribution agreements in effect on the Separation Date, and subject further to the non-competition covenants contained in Article IX of the Intellectual Property Matters Agreement.

 

1.3.          For purposes of this Agreement, “ HART Business means the development, manufacture and sale of products for use in human regenerative medicine. This includes the development, manufacture and sale of pumps for human clinical injections and bioreactors and scaffolds for regenerating human organs and tissues and products for use on humans (or on human cells, tissue or organs) as part of a procedure that involves an injection, implant or transplant into a human. As used in this Agreement, the term “HART Business” includes any of the aforementioned activities plus any natural expansion of such business in the regenerative medicine field for use in humans.

 

 
 

 

For purposes of this Agreement, “ Harvard Apparatus Research Business ” shall mean the business conducted by HBIO through its Original Harvard Apparatus, Warner and Hugo Sachs business units, where the Original Harvard Apparatus business unit refers to pumps and ventilators used mainly for research applications, provided that such definition of Harvard Apparatus Research Business expressly excludes Coulbourn, Panlab, CMA, BTX, Sample Prep or other products acquired and folded in from acquisitions after the original purchase of Harvard Apparatus by HBIO. The products of the Harvard Apparatus Research Business include pumps and various physiology tools for animal, organ, tissue and cell biology used mainly in research and in a few human applications as described in Section 9.2(d) of the Intellectual Property Matters Agreement. References to the “Harvard Apparatus Research Business” in this Agreement shall include this business as currently conducted or conducted in the future.

 

2               Distributor Obligations . In order to provide maximum protection and quality service to each of the Party’s customers, when acting as a distributor of the other party’s products (in each such instance, referred to herein as a “ Distributor ”) HBIO and HART each agree to comply with the following obligations. Failure to achieve and maintain such compliance shall constitute a material breach of this Agreement.

 

2.1           Distributor represents that: (a) the execution of this Agreement will not cause Distributor to breach any Agreement with any Third Party; and (b) so long as it continuing to act as Distributor to the other party hereunder for any particular product, with respect to such product, it has and shall use commercially reasonable efforts to maintain at all times the facilities, resources, personnel and experience to promote, advertise, market, and sell such product of the other Party and to otherwise perform its obligations under this Agreement. Distributor shall use commercially reasonable efforts to promote, market, distribute and sell the products and shall not perform any act which may hinder or interfere with the supply and/or marketing of the products. For purposes of this Agreement, “commercially reasonable efforts” means not less than the efforts used by HBIO immediately prior to the Separation Date to support the research applications of isolated organ and tissue products (but for the avoidance of nay doubt, expressly not including efforts pertaining to the HART Business or employees that will be moving to the HART Business as conducted by and at HBIO prior to the date hereof or thereafter), e.g., maintaining the sales force, applications specialists and technical support in the US and Europe, maintaining demo and sales inventory plus periodic outbound marketing consistent with its past practices. Notwithstanding anything to the contrary contained in this Agreement, nothing in this Agreement shall require HBIO or HART to provide services to the other unless expressly required hereby.

 

2.2           The Parties acknowledge and agree that HART’s use of the mark “HARVARD APPARATUS’ is at all times subject to the terms, conditions and restriction set forth in the Sublicense Agreement, dated December 8, 2012, by and between HART and HBIO (the “ Sublicense Agreement ”). The rights and obligations of the Parties in this paragraph are at all times subject to the Sublicense Agreement. Distributor shall not delete or alter any of the other Party’s trade names, trademarks, logos, markings, colors or other insignia (the “ Marks ”) which are affixed to the Products and included in related promotional materials. Distributor may only use the Marks in conjunction with Distributor’s marketing and sale of the Products and in accordance with the other Party’s then-current guidelines on Mark usage, which will be provided to Distributor at Distributor’s request. Distributor shall refrain from any other direct or indirect use, reference to, registration of or application to register the Marks or those confusingly similar unless such trademarks are authorized in writing by the other Party. Upon expiration or termination of this Agreement, Distributor shall immediately cease to use any and all Marks. Distributor agrees to immediately notify the other Party of any infringement or potential infringement of any Mark of which Distributor becomes aware.

 

2.3           Distributor shall be solely responsible, at its own expense, for obtaining and maintaining any and all governmental approvals, permits and/or certifications necessary for Distributor to import, purchase, sell and distribute products.

 

2.4           Distributor shall promptly advise the other Party of any complaints or claims brought or threatened against it or the other Party with respect to the sale or use of the products, or with respect to any alleged patent, copyright, trademark, or other intellectual property infringement or misappropriation.

 

2.5           Distributor shall take all reasonable, prompt and efficient actions to ensure customer satisfaction with the products and shall resolve all customer complaints in an expedited manner. In the event that a Party receives ten (10) or more complaints that do not relate to the design or manufacturing quality of a product from Distributor’s customers during any one (1) year period which indicate that Distributor has failed to satisfactorily resolve reasonable customer complaints in a timely fashion, such Party shall notify Distributor and Distributor shall be deemed to have breached this Agreement.

 

 
 

 

2.6           In no event shall Distributor make any representations or warranties regarding the products which are: (a) not included in, or which are inconsistent with information, materials or specification provided to Distributor; or (b) false, incomplete or otherwise misleading.

 

2.7           Distributor personnel shall participate in any training sessions regarding the products and their use as reasonably requested by the other Party.

 

2.8           With respect to any HBIO products that HART distributes in accordance herewith, HART agrees to represent and label clearly that such products are for research use only. With respect to any HART products that HBIO distributes in accordance herewith, HBIO agrees to represent and label clearly that such products are for research use only.

 

3               Prices and Payment.

 

3.1           During the term of this Agreement, Distributor shall purchase the applicable products (in accordance with 1.1 and 1.2) from the other Party at a [***] discount off of the then-current U.S. list price for the applicable product, provided that if the product is sourced by the other Party from a third party prior to sale to Distributor, Distributor shall purchase such product from the other Party at a [***] discount off of the then-current U.S. list price for the applicable product. All prices are exclusive of all taxes and other charges, including but not limited to, shipping, handling, insurance, brokerage and other related charges, governmental sales, use, consumption, excise, privilege, occupational, value-added or other similar taxes, customs duties or assessments.

 

3.2           Both HART and HBIO shall be free to unilaterally establish the prices charged to customers for their respective products.

 

3.3           Distributor shall pay for all products in U.S. Dollars. All payments are due thirty (30) days from the invoice date. Non-receipt of payment from a customer shall not excuse or delay payment by Distributor. Overdue payments will be subject to finance charges computed at a rate equal to the lesser of one and a half percent (1.5%) per month or the maximum amount permissible under applicable law. Distributor is responsible for payment of all losses, costs, attorneys’ fees, or other expenses incurred by the other Party in the event that the other Party in its sole discretion, hires a Third Party collection agency in order to recover amounts owed by Distributor.

 

3.4           Except for taxes based on the other Party’s net income and the medical device tax under the Patient Protection and Affordable Care Act, Distributor shall pay any applicable sales, use, consumption, excise, privilege, occupational, value-added or other similar taxes, customs duties or assessments, or amounts levied in lieu of such taxes, now or later imposed under the authority of any national, state or local taxing authority based on or measured by (a) charges set forth in this Agreement, (b) upon sales of the products to Distributor, or (c) upon import or export of any products. Any claim for sales tax or duty exemption by Distributor shall be effective only after the other Party’s receipt of all proper exemption forms.

 

3.5           Distributor shall pay or reimburse the other Party for all shipping costs including transportation, brokerage, handling, and other costs incurred in delivering the products to Distributor.

 

4               Ordering and Delivery.

 

4.1           Shipments of products shall only be made against written purchase orders issued by Distributor and which reference this Agreement. At a minimum, each purchase order shall specify the following items: (a) the quantity of product ordered; (b) the price of each product and any additional charges and costs; (c) the billing address, the destination to which the products will be delivered, and the requested delivery date; and (d) the signature of Distributor’s employee or agent who possesses the authority to place such an order.

 

4.2           All orders are subject to acceptance and assignment of delivery schedules in accordance with product availability. Neither Party shall have liability whatsoever for non-acceptance of, or failure or delay in filling any Distributor orders due to legitimate business considerations or acts or circumstances beyond its control, including without limitation, product shortages, production and delivery constraints, or government actions and acts of God. In no event shall any order be binding on HART or HBIO until the Parties are in agreement as to the items ordered, pricing, delivery dates, and all other material terms. Each Party shall use reasonable efforts to meet agreed-upon projected delivery dates for the products.

 

4.3           No purchase order, acknowledgment form, or other document or communication from either Party shall vary or supplement the terms and conditions of this Agreement. This Agreement may only be amended as provided in Section 14.11 hereof.

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

 
 

 

4.4           All deliveries of the products purchased pursuant to this Agreement will be made in a time, place and manner mutually agreed-upon by the Parties. Risk of loss and title to the products shall pass to Distributor upon delivery to the selected common carrier at the other Party’s manufacturing facility. Insurance coverage on all shipments is the responsibility of Distributor. All transportation and shipping costs shall be charged to Distributor’s account. Distributor must notify the other Party in writing within ten (10) days of receipt of products of any discrepancies in the shipment of such products.

 

4.5           All shipments shall be subject to a Party’s determination that such shipments are in compliance with all applicable export and import regulations. In no event shall either Party’s delay in shipping or refusal to ship due to export or import issues be deemed a material breach hereunder.

 

5               Records and Reports. Within forty-five (45) days after the end of each calendar quarter, Distributor shall promptly furnish written reports on sales, deliveries and returns of the products for the calendar quarter immediately preceding the report, including, without limitation, current inventory levels, a monthly breakdown of sales, and marketing efforts to prospective customers. Distributor shall maintain records identifying each product sold.

 

6               Product Warranty. Distributor shall pass along to its customers comparable product warranties as the other Party makes to its customers in the ordinary course of business.

 

6.1            Product Warranty.

 

6.2            Warranty Exclusions . This warranty does not extend to any products: (a) that have been subject to misuse, neglect, abuse, improper storage, accident (other than an accident caused by the product itself), or that have not been properly maintained; (b) that have been modified by any Third Party; or (c) that have been disassembled, serviced, or reassembled by any Third Party.

 

THE FOREGOING LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES AND EXCEPT FOR ANY EXPRESS WARRANTIES STATED HEREIN, HART AND HBIO EXPRESSLY DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, IMPLIED WARRANTIES OF QUALITY, CONDITION, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

7               Exchange of Information and Confidentiality . Article VII of the Separation and Distribution Agreement is hereby incorporated herein by reference.

 

8               Intellectual Property Rights .

 

8.1           During the term of this Agreement, Distributor is authorized to use the other Party’s Marks, trade names and logos solely in connection with Distributor’s sale, advertisement and promotion of the products in accordance with Section 2.2 hereof.

 

8.2           Except as described in this Agreement or the Intellectual Property Matters Agreement, neither HBIO nor HART grants to the other Party any right, license, or interest in any of the Intellectual Property owned, used or claimed now or in the future by HBIO or HART, respectively. All applicable rights to such Intellectual Property are, and will remain, the exclusive property of HART and HBIO, respectively. Regardless of any provision to the contrary in this Agreement, no title to or ownership of the Intellectual Property contained in the products, or any part of the products is transferred to Distributor. However, HART and HBIO each grant the other Party a limited, revocable, worldwide, royalty-free right and license to conduct demonstrations on the use of its products solely for the purposes of promoting the sale of such products in performing its obligations under this Agreement.

 

9               Indemnity and Insurance.

 

9.1           Distributor shall defend any claim, suit or proceeding, and indemnify and hold the other Party harmless from and against any Third Party Claims arising out of, or in connection with: (a) Distributor’s advertising, sales, marketing and promotional activities undertaken with respect to the products; (b) the failure of Distributor to comply in all material respects with all applicable laws, rules, and/or regulations regarding advertising, selling, licensing, importing or exporting the products; (c) Distributor’s attachment to the products of any trade name, trademark or logo that is challenged as an infringement of the proprietary rights of any Third Party; (d) any warranties granted by Distributor or any implied warranties claimed by any of Distributor’s customers, in excess of those warranties contained herein; (e) the failure of Distributor to comply with any material term of this Agreement; or (f) from any gross negligence or willful misconduct of Distributor in performing its obligations hereunder, except in each instance of (a)-(f) such Third-Party Claim is caused by the negligence or willful misconduct of the other non-Distributor Party. In addition, with respect to any Third-Party Claim pertaining to products manufactured or provided to one Party by the other Party hereunder, the Party that provided or manufactured such Product shall defend any claim, suit or proceeding, and indemnify and hold the other Party harmless from and against that portion of any Third Party Claims that arises out of, or is in connection with such product itself, including without limitation any injuries to or death of persons, or any damage to property, occurring as a result of, or in any way arising out of, defects of such products, except to the extent such Third Party Claims are caused by the other Party’s gross negligence of willful misconduct.

 

 
 

 

9.2           Any claims for indemnification pursuant to this Section 9 shall be made in accordance with the procedures set forth in Section 5.5 of the Separation and Distribution Agreement.

 

9.3            Insurance . Each Party agrees to maintain in full force and effect insurance coverage for the period of this Agreement pertaining to commercial general liability insurance coverage, including coverage for products liability and contractual indemnity. Said coverage will provide not less than commercially reasonable primary limits per occurrence in accordance with customary standards for the applicable industry. Each Party will cause its insurance carrier to designate the other Party as an “Additional Insured” on each applicable policy and any endorsement so naming such other Party will not limit its defense and coverage in favor of such Party to the negligence of the insured party.

 

9.4            Workers’ Compensation . The Parties agree to secure and keep in full force and effect during the life of this Agreement all forms of workers’ compensation and employers’ liability insurance coverage as is mandated by any state, territory or jurisdiction in which that Party does or may operate or send representatives. Each Party agrees that the other party is neither the actual nor statutory employer of any employee, consultant, representative, independent contractor or other person hired, retained, directed, utilized, consulted or engaged by such Party to carry out any of its duties under or arising from this Agreement.

 

10             Independent Contractor Status. Distributor shall conduct its business under this Agreement for its own account at its own expense and risk. The relationship between the parties is that of independent contractors. This Agreement creates no relationship of principal and agent, partner, joint venturer or any similar relationship between HART and HBIO. The grant of the distribution rights for the term hereof does not constitute a franchise or grant to Distributor of any continuing rights or interest in distributing the products beyond the term hereof. Distributor agrees that it does not have and will not have any authority to act on the other Party’s behalf.

 

11             Term and Termination .

 

11.1         This Agreement shall become effective as of the Separation Date and shall remain in effect for a period of ten (10) years thereafter, unless earlier terminated as set forth in this Section 11.

 

11.2         Either Party may terminate this Agreement in the event a material breach of the Agreement by the other Party hereto, including, without limitation, failure to fulfill its obligations pursuant to Section 2 hereof, after written notice and a sixty (60) day cure period.

 

11.3         In addition, HART may terminate its obligations to act as Distributor with respect to a particular product under this Agreement, after written notice and a sixty (60) day cure period, should HART determine, in its sole discretion, that HBIO is unwilling or unable to supply such HBIO – Applicable HART Distributor Businesses product subject to this Agreement to HART. HBIO may terminate its obligations to act as Distributor with respect to a particular product under this Agreement, after written notice and a sixty (60) day cure period, should HBIO determine, in its sole discretion, that HART is unwilling or unable to supply such HART Business product subject to this Agreement to HBIO.

 

11.4         The termination or expiration of this Agreement shall in no case relieve either Party from its obligation to pay to the other Party any sums accrued under this Agreement prior to such termination or expiration. If Distributor defaults on its payment obligations under this Agreement, the other Party shall have the right to take any or all of the following actions: (a) suspend delivery to Distributor until the default is cured by Distributor; or (b) terminate this Agreement after written notice and a thirty (30) day cure period. If the other Party continues to make shipments after Distributor’s default, such Party’s action shall not constitute a waiver of any rights or remedies, or affect such Party’s legal remedies under this Agreement.

 

 
 

 

11.5         Notwithstanding any other provision herein, this Agreement may be terminated immediately by either Party upon written notice in the event that the other Party: (a) becomes insolvent; (b) commits an act of bankruptcy; (c) seeks an arrangement or compromise with its creditors under any statute or otherwise; (d) is subject to a proceeding in bankruptcy, receivership, liquidation or insolvency and same is not dismissed within sixty (60) days; (e) makes an assignment for the benefit of the creditors; (f) admits in writing its inability to pay its debts as they mature; or (g) ceases to function as a going concern, or to conduct its operations in the normal course of business.

 

11.6         Within ten (10) days after termination or expiration of this Agreement, each Party shall return to the other Party all signs, literature, logos and other materials identifying the other Party’s products that remain in its possession.

 

12             Export Controls and Compliance with Law.

 

12.1         If an export license is required before Distributor can distribute or sell the Products, Distributor acknowledges and agrees that the other Party shall be under no obligation to affect such sale or transfer until the required export license is obtained. Each Party shall use reasonable efforts to expeditiously obtain such required export licenses or approvals.

 

12.2         Distributor acknowledges that the export of products and related technical data is subject to regulation by various rules and regulations of the United States which prohibit export or diversion to certain countries, entities and/or which restrict or prohibit use. Unless Distributor has first obtained permission to do so from all applicable United States Government agencies, Distributor shall not export or re-export, directly or indirectly, any products or related data into any of those countries listed at the time of any shipment in the applicable United States export regulations as “prohibited or restricted” countries, or any other country to which such exports or re-exports may be restricted (collectively, the “Prohibited Countries”). Distributor further agrees not to distribute or supply the products or any related technical data to any person if Distributor has reason to believe that such person intends to export, re-export or otherwise transfer the same to, or use the same in, any of the Prohibited Countries. Without limiting the foregoing, Distributor shall not commit any act which would, directly or indirectly, violate any United States or local law, regulation, treaty or agreement to which the United States adheres or complies relating to the export or re-export of the products or related technical data.

 

12.3         At its own expense, Distributor shall obtain any government consents, authorizations, approvals, filings, registrations, permits or licenses required for Distributor to exercise its rights and to discharge its obligations under this Agreement, provided further that, for the avoidance of any doubt, HART acknowledges and agrees that it, and not HBIO, shall be responsible for the efforts, cost and expense of obtaining any necessary regulatory approval for the manufacture and use of its products with humans, where regulatory approval means with respect to a regulatory jurisdiction, any and all approvals, product and/or establishment licenses, registrations or authorizations of any governmental authority, necessary for the commercial manufacture, use, storage, import, export, transport, or commercialization of a product in such regulatory jurisdiction, including, where applicable, (i) pricing and reimbursement approval in such regulatory jurisdiction, (ii) pre- and post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto), (iii) labeling approval, and (iv) technical, medical and scientific licenses.

 

12.4         In conformity with the United States Foreign Corrupt Practices Act neither HART and its employees and agents nor HBIO and its employees and agents shall directly or indirectly make any offer, payment, or promise to pay; authorize payment; or offer a gift, promise to give, or authorize the giving of anything of value for the purpose of influencing any act or decision (including a decision not to act) of an official of any government or inducing such a person to use his or her influence to affect any such governmental act or decision in order to assist HBIO or HART in obtaining, retaining or directing any business.

 

13             Limitation of Liability .

 

EXCEPT AS TO CLAIMS FOR BREACHES OF CONFIDENTIALITY, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR FOR DIRECT DAMAGES IN EXCESS OF THE AMOUNTS PAID BY HBIO OR HART FOR THE PRODUCT OR SUPPORT THAT GAVE RISE TO THE LIABILITY, WHETHER FORESEEABLE OR UNFORESEEABLE, OF ANY KIND WHATSOEVER (INCLUDING WITHOUT LIMITATION LOSS OF INCOME, DATA, GOODWILL, USE OF INFORMATION, DOWNTIME OR COSTS OF SUBSTITUTE PRODUCTS OR EQUIPMENT), WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY OR OTHERWISE, EVEN IF THE OTHER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

 

 
 

 

14             General.

 

14.1          Counterparts; Entire Agreement; Corporate Power . This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by facsimile, electronic transmission, or otherwise) to the other Party. This Agreement, together any exhibits hereto, and the Separation and Distribution Agreement (and Ancillary Agreements defined therein), contains the entire agreement between the Parties with respect to the subject matter hereof, supersede all previous agreements, negotiations, discussions, writings, understandings, commitments and conversations with respect to such subject matter and there are no agreements or understandings between the Parties other than those set forth or referred to herein or therein. HBIO and HART each represent as follows: (a) the person executing this Agreement has the requisite corporate or other power and authority and has taken all corporate or other action necessary in order to execute, deliver and perform each of this Agreement and to consummate the transactions contemplated hereby; and (b) this Agreement has been duly executed and delivered by it and constitutes a valid and binding agreement of it enforceable in accordance with the terms thereof. Each Party hereto acknowledges that it and each other Party hereto is executing this Agreement by facsimile, stamp or mechanical signature. Each Party hereto expressly adopts and confirms each such facsimile, stamp or mechanical signature made in its respective name as if it were a manual signature, agrees that it will not assert that any such signature is not adequate to bind such Party to the same extent as if it were signed manually and agrees that at the reasonable request of any other Party hereto at any time it will as promptly as reasonably practicable cause each such Agreement to be manually executed (any such execution to be as of the date of the initial date thereof).

 

14.2          Governing Law, Jurisdiction and Dispute Resolution . This Agreement (and any claims or disputes arising out of or related hereto or thereto or to the transactions contemplated hereby and thereby or to the inducement of any Party to enter herein and therein, whether for breach of contract, tortious conduct or otherwise and whether predicated on common law, statute or otherwise) shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth of Massachusetts irrespective of the choice of laws principles of the Commonwealth of Massachusetts as to all matters, including matters of validity, construction, effect, enforceability, performance and remedies. If any dispute arises out of or in connection with this Agreement, the parties (a) consent and submit to the exclusive jurisdiction of federal and state courts located in Boston, Massachusetts, and (b) waive any objection to that choice of forum based on venue or to the effect that the forum is not convenient. Notwithstanding the foregoing, any dispute arising out of or related to this Agreement shall be resolved in accordance with the procedures set forth in Section 9.1 of the Separation and Distribution Agreement. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

 

14.3          Assignability . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and thereto, respectively, and their respective successors and permitted assigns; provided, however, that no Party hereto or thereto may assign its respective rights or delegate its respective obligations under this Agreement without the express prior written consent of the other Party hereto or thereto (which consent may be withheld in such Party’s sole and absolute discretion) and any assignment or attempted assignment in violation of the foregoing will be null and void. Notwithstanding the preceding sentence, a Party may assign this Agreement in connection with a merger transaction in which such Party is not the surviving entity or the sale by such Party of all or substantially all of its Assets, and upon the effectiveness of such assignment the assigning Party shall be released from all of its obligations under this Agreement if the surviving entity of such merger or the transferee of such Assets shall agree in writing, in form and substance reasonably satisfactory to the other Party, to be bound by all terms of this Agreement as if named as a “Party” hereto.

 

14.4          Third-Party Beneficiaries . The provisions of this Agreement are solely for the benefit of the Parties and are not intended to confer upon any Person except the Parties any rights or remedies hereunder, and there are no third-party beneficiaries of this Agreement and this Agreement shall not provide any Third Party with any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.

 

14.5          Notices . All notices, requests, claims, demands or other communications under this Agreement shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile or electronic transmission with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 14.5). Any Party may, by written notice to the other Party, change the address to which such notices are to be given.

 

 
 

 

If to HBIO to:

 

Harvard Bioscience, Inc.

84 October Hill Road

Holliston, Massachusetts 01746

Attention: Chief Executive Officer

 

with a copy to (which will not constitute notice):

 

Burns & Levinson LLP

125 Summer Street

Boston, Massachusetts 02110

Attention:  Josef B. Volman

Chad J. Porter

 

If to HART to:

 

Harvard Apparatus Regenerative Technology

84 October Hill Road

Holliston, Massachusetts 01746

Attention: Chief Executive Officer

 

with a copy to (which will not constitute notice):

 

Feinberg Hanson LLP

57 River Street, Suite 204

Wellesley, Massachusetts 02481

Attention: Harry A. Hanson, III

 

14.6          Severability . If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, void or unenforceable, the remaining provisions hereof or thereof shall remain in full force and effect and shall in no way be affected, impaired or invalidated thereby. Upon such determination, the Parties shall negotiate in good faith in an effort to agree upon such a suitable and equitable provision to affect the original intent of the Parties.

 

14.7          Headings . The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 

14.8          Survival . Sections 6.2, 7, 9, 11.6, 13 and 14 shall survive the termination or expiration of this Agreement.

 

14.9          Waivers of Default . Waiver by any Party of any default by the other Party of any provision of this Agreement shall not be deemed a waiver by the waiving Party of any subsequent or other default, nor shall it prejudice the rights of the other Party. No failure or delay by any Party in exercising any right, power or privilege under this Agreement shall operate as a waiver thereof nor shall a single or partial exercise thereof prejudice any other or further exercise thereof or the exercise of any other right, power or privilege.

 

14.10        Specific Performance . Subject to the provisions of Section 14.2, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the Party or Parties who are, or are to be, thereby aggrieved shall have the right to specific performance and injunctive or other equitable relief in respect of its or their rights under this Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative. The Parties agree that the remedies at law for any breach or threatened breach, including monetary damages, are inadequate compensation for any loss and that any defense in any action for specific performance that a remedy at law would be adequate is waived. Any requirements for the securing or posting of any bond with such remedy are waived by each of the Parties to this Agreement.

 

 
 

 

14.11        Amendments . No provisions of this Agreement shall be deemed waived, amended, supplemented or modified by any Party, unless such waiver, amendment, supplement or modification is in writing and (a) in the case of a waiver, signed by the authorized representative of the Party against whom it is sought to enforce such waiver, or (b) in the case of an amendment, supplement or modification to this Agreement, signed by the authorized representatives of both Parties.

 

14.12        Interpretation . In this Agreement, (a) words in the singular shall be held to include the plural and vice versa and words of one gender shall be held to include the other genders as the context requires; (b) the terms “hereof,” “herein,” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole (including any exhibits hereto) and not to any particular provision of this Agreement; (c) Article, Section, and exhibit references are to the sections and exhibits to this Agreement unless otherwise specified; (d) the word “including” and words of similar import when used in this Agreement shall mean “including, without limitation,” (e) the word “or” shall not be exclusive; (f) unless expressly stated to the contrary in this Agreement, all references to “the date hereof,” “the date of this Agreement,” “hereby” and “hereupon” and words of similar import shall all be references to [ ], 2013, regardless of any amendment or restatement hereof.

 

14.13        Force Majeure . No Party shall be deemed in default of this Agreement to the extent that any delay or failure in the performance of its obligations under this Agreement results from a Force Majeure (as defined in the Separation and Distribution Agreement). In the event of an occurrence of a Force Majeure, the Party whose performance is affected thereby shall give notice of suspension as soon as reasonably practicable to the other stating the date and extent of such suspension and the cause thereof, and such Party shall resume the performance of such obligations as soon as reasonably practicable after the removal of such cause.

 

[Signature Page Follows]

 

 
 

 

IN WITNESS WHEREOF, the Parties have caused this Product Distribution Agreement to be executed by their duly authorized representatives.

 

  HARVARD BIOSCIENCE, INC.
     
  By:  
    Name:
    Title:
   
  HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
   
  By:  
    Name:
    Title:

 

 

 

 

EXHIBIT 10.17

 

CONFIDENTIAL TREATMENT REQUESTED

 

The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934 as amended.

 

REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***].

 

INTELLECTUAL PROPERTY MATTERS AGREEMENT

BY AND BETWEEN

HARVARD BIOSCIENCE, INC.


and


HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

 
Dated as of [    •    ], 2013

 

 
 

 

INTELLECTUAL PROPERTY MATTERS AGREEMENT

 

        THIS INTELLECTUAL PROPERTY MATTERS AGREEMENT (this “ Agreement ”) is dated as of [    •    ], 2013, by and between Harvard Bioscience, Inc., a Delaware corporation (“ HBIO ”), and Harvard Apparatus Regenerative Technology, a Delaware corporation and a wholly owned subsidiary of HBIO (“ HART ”). HBIO and HART are each referred to herein as a “ Party ” and collectively as the “ Parties .”

 

WITNESSETH:

 

WHEREAS, HBIO is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine;

 

WHEREAS, among its various business activities, HBIO operates various lines of business related to the development, manufacturing and marketing of apparatus and scientific instruments, including the Harvard Apparatus Research Business (as defined below) and the HART Business (as defined below);

 

WHEREAS, pursuant to the Separation and Distribution Agreement to be entered into by and between HBIO and HART, (the “ Separation and Distribution Agreement ”), the Parties have agreed to separate the HART Business from HBIO;

 

WHEREAS, it is the intent of the Parties, in accordance with the Separation and Distribution Agreement and the other agreements and instruments provided for therein, that HBIO convey to HART all of the business and assets of the HART Business, including certain intellectual property rights;

 

WHEREAS, it is the intent of the Parties that HBIO convey and license certain intellectual property rights to HART and for HART to grant a license back to HBIO to certain transferred intellectual property rights subject to the terms and conditions set forth in this Agreement;

 

WHEREAS, the Parties also intend to license certain other intellectual property rights to each other for use in their respective businesses, subject to certain limitations on competitive uses as set forth herein;

 

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and agreements set forth below, and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties hereby agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

1.1.           Definitions .

 

Capitalized terms used in this Agreement shall have the meanings ascribed to them in the Separation and Distribution Agreement or in this Article I. In the event of any conflict between the definitions in this Agreement and in the Separation and Distribution Agreement, the terms of this Agreement shall control.

 

The following terms, as used in this Agreement, have the following meanings:

 

HART Business ” means the development, manufacture and sale of products for use in human regenerative medicine. This includes the development, manufacture and sale of pumps for human clinical injections and bioreactors and scaffolds for regenerating human organs and tissues and products for use on humans (or on human cells, tissue or organs) as part of a procedure that involves an injection, implant or transplant into a human. As used in this Agreement, the term “HART Business” includes any of the aforementioned activities plus any natural expansion of such business in the regenerative medicine field for use in humans by comparable companies in the regenerative medicine field for use in humans.

 

HART Group ” shall have the meaning ascribed to it the Separation and Distribution Agreement.

 

2
 

 

HART Indemnitees ” shall have the meaning ascribed to it the Separation and Distribution Agreement.

 

Harvard Apparatus Research Business ” shall mean the business conducted by HBIO through the Original Harvard Apparatus, Warner and Hugo Sachs business units, where the Original Harvard Apparatus business unit refers to pumps and ventilators used mainly for research applications, provided that such definition of Harvard Apparatus Research Business expressly excludes Coulbourn, Panlab, CMA, BTX, Sample Prep or other products acquired and folded in from acquisitions after the original purchase of Harvard Apparatus by HBIO. The products of the Harvard Apparatus Research Business include pumps and various physiology tools for animal, organ, tissue and cell biology used mainly in research and in a few human applications as described in Section 9.2(d) below. References to the Harvard Apparatus Research Business” in this Agreement shall include this business as currently conducted or conducted in the future.

 

HBIO Group ” shall have the meaning ascribed to it the Separation and Distribution Agreement.

 

HBIO Indemnitees ” shall have the meaning ascribed to it the Separation and Distribution Agreement.

 

Know-How ” means the expertise and knowledge related to a particular Technology or Intellectual Property.

 

Improvement ” to any Intellectual Property or Technology means, in part, (a) with respect to Copyrights, any modifications, derivative works and translations of works of authorship in any medium, including, without limitation, any database that is created by extraction or re-utilization of another database; (b) with respect to Technology, any improvement or modification to the Trade Secrets that cover or are otherwise incorporated into Technology.

 

Information ” shall have the meaning ascribed to it in the Separation and Distribution Agreement.

 

Insolvency Event ” arises when a Party: (a) becomes insolvent; (b) commits an act of bankruptcy; (c) seeks an arrangement or compromise with its creditors under any statute or otherwise; (d) is subject to a proceeding in bankruptcy, receivership, liquidation or insolvency and same is not dismissed within sixty (60) days; (e) makes an assignment for the benefit of the creditors; (f) admits in writing its inability to pay its debts as they mature; or (g) ceases to function as a going concern, or to conduct its operations in the normal course of business.

 

Intellectual Property ” means all of the following whether arising under the Laws of the United States or of any other foreign or multinational jurisdiction: (i) patents, patent applications (including patents issued thereon) and statutory invention registrations, including reissues, divisions, continuations, continuations in part, substitutions, renewals, extensions and reexaminations of any of the foregoing, and all rights in any of the foregoing provided by international treaties or conventions (“ Patents ”), (ii) trademarks, service marks, trade names, service names, trade dress, logos and other source or business identifiers, including all goodwill associated with any of the foregoing, and any and all common law rights in and to any of the foregoing, registrations and applications for registration of any of the foregoing, all rights in and to any of the foregoing provided by international treaties or conventions, and all reissues, extensions and renewals of any of the foregoing (“ Trademarks ”), (iii) Internet domain names, (iv) copyrightable works, copyrights, moral rights, mask work rights, database rights and design rights, in each case, other than Software, whether or not registered, and all registrations and applications for registration of any of the foregoing, and all rights in and to any of the foregoing provided by international treaties or conventions (“ Copyrights ”), (v) confidential and proprietary information, including trade secrets, invention disclosures, processes and Know-How, in each case, other than Software (“ Trade Secrets ”), (vi) intellectual property rights arising from or in respect of any Technology, and (vii) Software, other than commercially available “off-the-shelf” software.

 

Liabilities ” shall have the meaning set forth in the Separation and Distribution Agreement.

 

Laws ” shall have the meaning set forth in the Separation and Distribution Agreement.

 

New HART Technology shall have the meaning set forth in Section 4.2 hereof.

 

New HBIO Technology shall have the meaning set forth in Section 3.2 hereof.

 

Notifying Party ” shall have the meaning set forth in Section 5.7 hereof.

 

Person ” shall have the meaning set forth in the Separation and Distribution Agreement.

 

3
 

 

Rejected New Hart Technology ” shall have the meaning set forth in Section 4.2 hereof.

 

Rejected New HBIO Technology ” shall have the meaning set forth in Section 3.2 hereof.

 

Separation Date ” shall have the meaning set forth in the Separation and Distribution Agreement.

 

Software ” means any and all (i) computer programs, including any and all software implementation of algorithms, models and methodologies, whether in source code, object code, human readable form or other form, (ii) databases and compilations, including any and all data and collections of data, whether machine readable or otherwise, (iii) descriptions, flow charts and other work products used to design, plan, organize and develop any of the foregoing, screens, user interfaces, report formats, firmware, development tools, templates, menus, buttons and icons, and (iv) documentation, including user manuals and other training documentation, relating to any of the foregoing.

 

Subsidiary ” shall have the meaning set forth in the Separation and Distribution Agreement.

 

Technology ” means tangible embodiments, whether in electronic, written or other media, of technology, including designs, design and manufacturing documentation (such as bill of materials, build instructions and test reports), schematics, algorithms, routines, software, databases, lab notebooks, development and lab equipment, processes, prototypes and devices. Technology does not include Intellectual Property in any of the foregoing.

 

Third Party ” means any Person other than a Party.

 

Third-Party Claims ” shall have the meaning ascribed to it the Separation and Distribution Agreement.

 

Transferred Intellectual Property ” means: (a) the Patents listed on Exhibit A hereto; (b) other inventions and Intellectual Property for which patent, trademark or copyright applications, as applicable, have not been filed that were originated in the HART Business prior to the Separation Date, including, without limitation, those inventions described on Exhibit A attached hereto; (c) the HART Software as defined in the Separation and Distribution Agreement); (d) trade secrets, know how or other Intellectual Property related to the HART Business owned or licensed by HBIO prior to the Separation Date; and (e) all Know-How related to the items listed in (a) through (d) above.

 

Transferred Licenses ” means the license agreements and other licensed Intellectual Property listed on Exhibit B hereto, and all Know-How related to the same.

 

ARTICLE II

 

TRANSFERRED INTELLECTUAL PROPERTY RIGHTS AND TECHNOLOGY

 

2.1.           Assignment of Intellectual Property .     HBIO hereby agrees to, and to cause its Affiliates and Subsidiaries to, grant, assign and convey to HART the Transferred Intellectual Property. For the avoidance of doubt, the Transferred Intellectual Property is transferred subject to the licenses granted to HBIO in Article IV below, and the competitive restrictions in Article IX below. The Transferred Intellectual Property include all of HBIO’s right, title and interest in and to any and all proceeds, causes of action and rights of recovery against Third Parties for past and future infringement or misappropriation of any of the Transferred Intellectual Property. The Parties shall execute an Intellectual Property Assignment in a form reasonably satisfactory to the Parties to document the transfer of the Transferred Intellectual Property. HART shall have the sole responsibility, at its sole cost and expense, to file the Intellectual Property Assignment and any other forms or documents as required to record the assignment of the Transferred Intellectual Property from HBIO to HART; provided however, that, upon request, HBIO shall provide reasonable assistance to HART to record the assignment, at HART's sole cost and expense. HART shall be responsible for the prosecution and maintenance of all Patents included within the Transferred Intellectual Property.

 

4
 

 

2.2.           Assignment and Assumption of Intellectual Property Licenses .     HBIO hereby assigns and conveys to HART, and agrees to cause its Affiliates and Subsidiaries to assign and convey to HART, the Transferred Licenses, and HART hereby assumes from HBIO and its Affiliates and Subsidiaries the Transferred Licenses, in each case subject to the terms, conditions and restrictions of each such Transferred License. HBIO acknowledges and agrees that it shall have sole responsibility to seek and obtain the consent of any Third Party necessary for the transfer of any of the Transferred Licenses, and HART shall bear sole responsibility for any consideration necessary for their transfer. Upon request, HART will provide reasonable assistance in obtaining such consent, at HART’s sole expense. For the avoidance of doubt, and subject to the terms and conditions of the Transferred Licenses, HART hereby succeeds to all of the rights and responsibilities of HBIO under each such Transferred License, including any liabilities arising under the Transferred Licenses prior to the Separation Date, which liabilities shall be the responsibility of HART.

 

2.3.           Transfer of Business Technology and Know-How .     HBIO hereby agrees to, and to cause its Affiliates and Subsidiaries to, grant, assign and convey to HART all Technology and Know-How used in the HART Business. For the avoidance of doubt, the transfer of the Technology and Know-How used in the HART Business does not include the transfer of any Intellectual Property in any Technology used in the HART Business; such Intellectual Property is transferred to HART as Transferred Intellectual Property in Section 2.1 above.

 

ARTICLE III

 

LICENSES TO HART

 

3.1.           License to Existing Intellectual Property . HBIO hereby grants, and agrees to cause its Affiliates and Subsidiaries to grant, to HART an exclusive, worldwide, royalty free, sublicensable and transferable right and license to use, solely in the HART Business, all Intellectual Property, Technology and related Know-How that exists on the date hereof and was developed by HBIO in the Harvard Apparatus Research Business, including without limitation the Intellectual Property, Technology and related Know-How pertaining to Hugo-Sachs that are remaining with the HBIO Group following the Separation. The license granted by HBIO to HART under this Section 3.1 shall remain in effect with respect to each Patent included in the license under this Section 3.1, until the date on which such Patent shall expire. The foregoing exclusive license grant shall not exclude or limit any member of the HBIO Group from their continued use of such all Intellectual Property, Technology and related Know-How, subject to Article IX hereof.

 

3.2.           Other Intellectual Property Rights .   HBIO hereby grants, and agrees to cause its Affiliates and Subsidiaries to grant, to HART a perpetual, exclusive, worldwide, sublicensable and transferable right and license to use, solely in connection with the HART Business for the period described below in Section 3.3, all Intellectual Property, Technology and related Know-How developed by HBIO in the Harvard Apparatus Research Business (collectively, the “ New HBIO Technology ”). The foregoing exclusive license grant shall not exclude or limit any member of the HBIO Group from their continued use of the New HBIO Technology , subject to Article IX hereof. HBIO and each other member of the HBIO Group, as applicable, shall retain any and all rights with respect to the New HBIO Technology other than the license granted to HART in this Section 3.2. During the term of such license, HBIO shall use commercially reasonable efforts to notify HART in writing promptly following the development of any New HBIO Technology (provided that the failure to provide any such notice shall not be deemed to be a breach of this Agreement or give rise to any claims or termination rights hereunder). Upon the receipt of such notice, HART shall have sixty (60) days to elect to either license such New HBIO Technology in accordance with the above provisions, after which such time, if HART fails to make such election, or elects not take such license, HBIO shall have no obligations to HART under this Article III with respect to such non-elected/rejected New HBIO Technology (the “ Rejected New HBIO Technology ”). Any disclosures made pursuant to this Section 3.2 shall be treated as “Information” for purposes of this Agreement.

 

3.3.           Term of License Grant and Assistance . The licenses granted by HBIO to HART to the New HBIO Technology under Section 3.2 shall remain in effect until the first to occur of: (a) the date on which HART ceases to actively use the New HBIO Technology in its HART Business, which date shall be no sooner than one year after disclosure; (b) with respect to each Patent included in the New HBIO Technology subject to the licenses, the date on which such Patent shall expire; or (c) an Insolvency Event occurs with respect to HART. For purposes of this Agreement, HART will be deemed to be actively using the New HBIO Technology if either: (i) any New HBIO Technology is incorporated into any products being developed, manufactured, marketed, distributed or sold by HART or any Third Party on behalf of HART; or (ii) HART is actively using, or has actively used within the previous six (6) month period, the New HBIO Technology as part of its research and development efforts for the HART Business.

 

5
 

 

During the term of the license granted to HART under Section 3.2, from time to time during the initial three (3) month period following the respective license grant, upon the reasonable request of HART, HBIO agrees to use its commercially reasonable efforts to provide assistance to HART to enable to HART to assess and setup the technology pertaining to such license, including such services as minor software changes or explaining manufacturing and testing procedures.  In connection with any request for such assistance, HBIO and HART shall in good faith negotiate the charge applicable to such assistance, which charge shall be borne solely by HART. Notwithstanding the above, until five years from the Separation Date, the licenses granted in accordance with Section 3.2 above shall be royalty-free, and should HART desire to continue the license of the New HBIO Technology thereafter, the Parties shall negotiate in good faith commercially reasonable payment terms of such continued license. The license shall continue during the period of such negotiations.

 

3.4.           Third Party Licenses .     With respect to Intellectual Property licensed to HBIO or its Affiliates or Subsidiaries by a Third Party, the license grants set forth in this Article III shall be subject to all of the conditions set forth in the relevant license agreement between HBIO (or its Affiliate or Subsidiary, as the case may be) and such Third Party, in addition to all of the terms, conditions and restrictions set forth herein. Licenses to HART under Sections 3.1 and 3.2 pertaining to Intellectual Property owned by a Third Party shall expire on the expiration of the term of the corresponding license agreement between such Third Party and HBIO (or its Subsidiary or its Affiliate), as the case may be. If such Third Party licenses do not permit a license or sublicense to by HBIO or its Affiliates or Subsidiaries to HART or its Affiliates or Subsidiaries, then the provisions of Sections 3.1 and 3.2 and related sections of this Article III shall not be applicable with respect to such licenses, provided that if HART requests that HBIO seek to obtain the consent of such Third Party to any such sublicense, HBIO will review such request in good faith and if it determines in it reasonable discretion that such consent request would not have any adverse impact in HBIO or its Affiliates or Subsidiaries, then HBIO shall use commercially reasonable efforts to make one attempt to obtain such consent, and if such consent is provided then the provisions of Sections 3.1 and 3.2 and related sections of this Article III shall apply.

 

3.5.           Software .     With respect to Software included within the New HBIO Technology, such licenses include the right to use, modify, and reproduce such software, in source code and object code form and Improvements thereof made by or on behalf of HART.

 

3.6.           Have Made Rights .     The licenses to HART in Sections 3.1 and 3.2 above shall include the right to have Third Parties manufacture or distribute products for HART, subject to the rights granted to HBIO in the Product Distribution Agreement.

 

3.7.             Improvements .     As between HBIO and its Affiliates and Subsidiaries on the one hand, and HART and its Affiliates and Subsidiaries on the other hand, HART hereby retains all right, title and interest, including all Intellectual Property, in and to any Improvements made by or on behalf of HART: (a) to any of the Transferred Intellectual Property, or (b) in the exercise of the licenses granted to it by HBIO and its Affiliates and Subsidiaries in this Article III, subject in each case only to the ownership interests of HBIO, its Affiliates and Subsidiaries in the underlying Intellectual Property improved thereby. Notwithstanding the foregoing, HART shall not file a patent application with respect to any Improvements on any New HBIO Technology without the prior written consent of HBIO.

 

3.8.           No Restrictions on HBIO . Subject to Article IX hereof, the licenses granted in Section 3.1 and 3.2 hereof shall in no way limit the ability of HBIO to use the New HBIO Technology with respect to uses outside the HART Business. HBIO will bear sole responsibility and cost for prosecuting and maintaining Patents that it owns, and shall have the sole authority to make decisions regarding the prosecution of Patents included in the New HBIO Technology.

 

6
 

 

3.9.           Strategic Transactions . For the avoidance of any doubt, in the event that HBIO or the Harvard Apparatus Research Business is acquired by another non-affiliated entity (an “Acquiror”), such Acquiror shall only be subject to Section 3.2 with respect to New HBIO Technology developed with respect to its operation of the Harvard Apparatus Research Business, and shall expressly not be subject to Section 3.2 with respect to all Intellectual Property, Technology and related Know-How developed by the Acquiror in its other business operations outside of the Harvard Apparatus Research Business .

 

ARTICLE IV

 

LICENSES TO HBIO

 

4.1.           License to Existing Intellectual Property .      HART hereby grants, and agrees to cause its Affiliates and Subsidiaries to grant, to HBIO an exclusive (for use by HBIO, and its Affiliates and Subsidiaries, only with respect the Harvard Apparatus Research Business, and such term “exclusive” shall expressly not exclude or limit HART and its subsidiaries from their continued use of the related Transferred Intellectual Property in accordance herewith), worldwide, royalty free, sublicensable and transferable right and license to use the Transferred Intellectual Property solely in the Harvard Apparatus Research Business. Except for the license granted to HBIO in this Section 4.1, HART shall retain any and all rights with respect to such Transferred Intellectual Property. The license granted by HART to HBIO under this Section 4.1 shall remain in effect with respect to each patent included in the license under this Section 4.1, until the date on which such patent shall expire.

 

4.2.           Other Intellectual Property Rights . HART hereby grants, and agrees to cause its Affiliates and Subsidiaries to grant, to HBIO a perpetual, exclusive, worldwide, sublicensable and transferable right and license to use, solely in connection with the Harvard Apparatus Research Business for the period described below in Section 4.3, all Intellectual Property, Technology and related Know-How developed by HART in the HART Business (collectively, the “ New HART Technology ”). The foregoing exclusive license grant shall not exclude or limit any member of the HART Group from their continued use of the New HART Technology , subject to Article IX hereof. Should HBIO desire to license the New HART Technology for use outside the scope of the Harvard Apparatus Research Business, the Parties shall negotiate in good faith the terms and conditions, including the payment terms, of such license. HART and each other member of the HART Group, as applicable, shall retain any and all rights with respect to the New HART Technology other than the license granted to HBIO in this Section 4.2. During the term of such license, HART shall use commercially reasonable efforts to notify HBIO in writing promptly following the development of any New HART Technology (provided that the failure to provide any such notice shall not be deemed to be a breach of this Agreement or give rise to any claims or termination rights hereunder). Upon the receipt of such notice, HBIO shall have sixty (60) days to elect to either license such New HART Technology in accordance with the above provisions, after which such time, if HBIO fails to make such election, or elects not take such license, HART shall have no obligations to HBIO under this Article IV with respect to such non-elected/rejected New HART Technology (the “ Rejected New HART Technology ”). Any disclosures made pursuant to this Section 3.2 shall be treated as “Information” for purposes of this Agreement.

 

4.3.           Term of License Grant and Assistance. The licenses granted by HART to HBIO to the New HART Technology under Section 4.2 shall remain in effect until the earlier to occur of: (a) the date on which HBIO ceases to actively use the New HART Technology in its Harvard Apparatus Research Business, which date shall be no sooner than one year after disclosure; (b) with respect to each Patent included in the New HART Technology, the date on which such Patent shall expire, or (c) an Insolvency Event occurs with respect to HBIO. For purposes of this Agreement, HBIO will be deemed to be actively using the New HART Technology if either: (i) any New HART Technology is incorporated into any products being developed, manufactured, marketed, distributed or sold by HBIO or any Third Party on behalf of HBIO; or (ii) HBIO is actively using, or has actively used within the previous six (6) month period, the New HART Technology as part of its research and development efforts for the Harvard Apparatus Research Business.

 

During the term of the license granted to HART under Section 4.2, from time to time during the initial three (3) month period following the respective license grant, upon the reasonable request of HBIO, HART agrees to use its commercially reasonable efforts to provide assistance to HBIO to enable to HBIO to assess and setup the technology pertaining to such license, including such services as minor software changes or explaining manufacturing and testing procedures.  In connection with any request for such assistance, HBIO and HART shall in good faith negotiate the charge applicable to such assistance, which charge shall be borne solely by HBIO. Notwithstanding the above, until five years from the Separation Date, the licenses granted in accordance with Section 4.2 above shall be royalty-free, and should HBIO desire to continue the license of the New HART Technology thereafter, the Parties shall negotiate in good faith commercially reasonable payment terms of such continued license. The license shall continue during the period of such negotiations.

 

7
 

 

4.4.           Third Party Licenses .     With respect to Intellectual Property licensed to HART or its Affiliates or Subsidiaries by a Third Party, the license grants set forth in this Article IV shall be subject to all of the conditions set forth in the relevant license agreement between HART (or its Affiliate or Subsidiary, as the case may be) and such Third Party, in addition to all of the terms, conditions and restrictions set forth herein. Licenses to HBIO under this Article IV pertaining to Intellectual Property owned by a Third Party shall expire on the expiration of the term of the corresponding license agreement between such Third Party and HART (or its Subsidiary or its Affiliate), as the case may be.   If such Third Party licenses do not permit a license or sublicense by HART or its Affiliates or Subsidiaries to HBIO or its Affiliates or Subsidiaries, then the provisions of Sections 4.1 and 4.2 and related sections of this Article IV shall not be applicable with respect to such licenses, provided that if HBIO requests that HART seek to obtain the consent of such Third Party to any such sublicense, HART will review such request in good faith and if it determines in it reasonable discretion that such consent request would not have any adverse impact in HART or its Affiliates or Subsidiaries, then HART shall use commercially reasonable efforts to make one attempt to obtain such consent, and if such consent is provided then the provisions of Sections 4.1 and 4.2 and related sections of this Article IV shall apply.

 

4.5.           Software .     Without limiting the generality of the foregoing licenses granted in Sections 4.1 and 4.2, with respect to Software included within the New HART Technology, such licenses include the right to use, modify, and reproduce such software, in source code and object code form and Improvements thereof made by or on behalf of HBIO or its Subsidiaries.

 

4.6.           Have Made Rights .     The licenses granted to HBIO in Sections 4.1 and 4.2 above shall include the right to have Third Parties manufacture and distribute products of HBIO, subject to the distribution rights granted to HART under the Product Distribution Agreement.

 

4.7.           Improvements .     As between HBIO and its Affiliates and Subsidiaries on the one hand and HART and its Affiliates and Subsidiaries on the other hand, HBIO and its Affiliates and Subsidiaries hereby retain all right, title and interest, including all Intellectual Property, in and to any Improvements made by or on behalf of HBIO or its Affiliates or Subsidiaries in the exercise of the licenses granted to it by HART and its Affiliates and Subsidiaries, subject only to the ownership of HART in the underlying Intellectual Property improved thereby. Notwithstanding the foregoing, HBIO shall not file a patent application with respect to any Improvements on any New HART Technology without the prior written consent of HART.

 

4.8.           No Restrictions on HART . Subject to Article IX hereof, the licenses granted in Section 4.1 and 4.2 hereof shall in no way limit the ability of HART to use the New HART Technology in the HART Business. HART will bear sole responsibility and cost for prosecuting and maintaining Patents that it owns, and shall have the sole authority to make decisions regarding the prosecution of Patents included in the New HART Technology.

 

4.9.           Strategic Transactions . For the avoidance of any doubt, in the event that HART or the HART Business is acquired by an Acquiror: (a) such acquisition shall not constitute a violation of Article IX, even if the Acquiror’s business is outside the scope of the HART Business; and (b) such Acquiror shall only be subject to Section 4.2 with respect to New HART Technology developed with respect to its operation of the HART Business, and shall expressly not be subject to Section 4.2 with respect to all Intellectual Property, Technology and related Know-How developed by the Acquiror in its other business operations outside of the HART Business.

 

8
 

 

ARTICLE V

 

ADDITIONAL INTELLECTUAL PROPERTY RELATED MATTERS

 

5.1.           Assignments and Licenses .     No Party may assign or grant a license under any of such Party's Intellectual Property Rights which it has licensed to the other Party in Article III or IV above, unless such assignment or grant is made subject to the licenses granted herein.

 

5.2.           Assistance by Employees .     Each Party agrees that its employees and contractors have a continuing duty to assist the other Party with the prosecution of the other Party's Patents and, accordingly, each agrees to make available to the other Party or its counsel inventors and other reasonably necessary persons employed by it for interviews and/or testimony to assist in good faith in further prosecution, maintenance or litigation of such Patents, including the signing of documents related thereto. Any actual and reasonable out-of-pocket expenses associated with such assistance shall be borne by the Party that owns the Patent, expressly excluding the value of the time of each Party's personnel.

 

5.3.           Assistance with Litigation .     In the case of assistance with Third Party litigation pertaining to any of the Intellectual Property transferred in Article II or licensed in Articles III or IV above, the Parties shall agree on a case by case basis on reasonable compensation, for the value of the non-litigating Party's employee's time as reasonably required in connection with any such litigation.

 

5.4.           No Implied Licenses .     Nothing contained in this Agreement shall be construed as conferring any rights by implication, estoppel or otherwise, under any Intellectual Property, other than as expressly granted in this Agreement.

 

5.5.           Obligation to Prosecute Patents .     Each Party shall use commercially reasonable efforts to protect, perfect and maintain its Intellectual Property, provided, however that nothing in this Agreement shall obligate either Party to file any patent application, to prosecute any Patent or secure any Patent rights or to maintain any Patent in force. Notwithstanding the foregoing, should HBIO decide to abandon or let lapse any Patents included within the New HBIO Technology, it shall so notify HART in writing at least thirty (30) days in advance of the next filing deadline applicable to such Patent, and give HART the option of taking over such Patent under reasonable conditions (including, for example, acknowledgement of prior Third Party rights, license back to HBIO , and similar conditions consistent with this Agreement) mutually agreed-upon by the Parties. Notwithstanding the foregoing, should HART decide to abandon or let lapse any Patents included within the Transferred Intellectual Property that is subject to license to HBIO in accordance with Section 4.1, or New HART Technology, it shall so notify HBIO in writing at least thirty (30) days in advance of the next filing deadline applicable to such Patent, and give HBIO the option of taking over such Patent under reasonable conditions (including, for example, acknowledgement of prior Third Party rights, license back to HART, and similar conditions consistent with this Agreement) mutually agreed-upon by the Parties.

 

5.6.           Reconciliation .     The Parties acknowledge that, as part of the transfer of the Transferred Intellectual Property and the Transferred Licenses, members of the HBIO Group or their Affiliates may inadvertently retain Technology or Intellectual Property that should have been transferred to HART pursuant to Article II of this Agreement, and HART may inadvertently acquire Technology or Intellectual Property that should not have been transferred. Each Party agrees to negotiate, in good faith, the transfer to the other of any such later identified Technology or Intellectual Property, subject to the licenses set forth in Articles III and IV above, at the reasonable written request of the other Party.

 

5.7.           Third-Party Infringement .     No Party shall have any obligation hereunder to institute or maintain any action or suit against Third Parties for infringement or misappropriation of any Intellectual Property in or to any Technology licensed to the other Party hereunder, or to defend any action or suit brought by a Third Party which challenges or concerns the validity of any of such Intellectual Property or which claims that any Technology licensed to the other Party hereunder infringes or constitutes a misappropriation of any Intellectual Property of any Third Party. Each Party (the " Notifying Party ") has the continuing obligation to promptly notify the other Party in writing upon learning of a Third Party likely infringing upon or misappropriating any Intellectual Property of the other Party which is licensed to the Notifying Party in this Agreement. Such notification shall set forth in reasonable specificity the identity of the suspected infringing Third Party and the nature of the suspected infringement.

 

9
 

 

5.8.           Trademark License .     The parties acknowledge and agree that HBIO has granted HART a sublicense to use the mark “HARVARD APPARATUS” pursuant to the Sublicense Agreement and the terms, conditions and limitations set forth therein.

 

ARTICLE VI

 

AUDIT RIGHTS

 

6.1.           Audit Rights . Until the expiration of the non-competition and non-solicitation covenants in accordance with Section 9.4 hereof, each of HBIO and HART or its appointed representatives shall have the right to audit the relevant books and records of the other Party to confirm the other Party’s compliance with the non-competition and non-solicitation requirements of Article IX of this Agreement. Audits will be conducted during regular business hours and in a manner that does not unreasonably interfere with the operation of the business of the Party being audited. Audits may be conducted by an employee of the auditing Party as well as by any attorney or accounting firm designated by an employee of the auditing Party who is subject to confidentiality obligations at least as protective of the disclosing Party’s Information as those contained in this Agreement. Any such audit will be conducted at the auditing Party’s expense.

 

ARTICLE VII

 

CONFIDENTIALITY

 

7.1.           Exchange of Information and Confidentiality .     Article VII of the Separation and Distribution Agreement is incorporated herein by this reference.

 

ARTICLE VIII

 

LIMITATION OF LIABILITY & WARRANTY DISCLAIMER

 

8.1.           Limitation of Liability .      IN NO EVENT SHALL ANY PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INDIRECT, INCIDENTAL OR PUNITIVE DAMAGES OR LOST PROFITS, HOWEVER CAUSED AND BASED ON ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE) ARISING IN ANY WAY OUT OF THIS AGREEMENT, WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING SHALL NOT, HOWEVER, LIMIT THE DAMAGES AVAILABLE TO A PARTY FOR INFRINGEMENT OR MISAPPROPRIATION OF ITS INTELLECTUAL PROPERTY BY THE OTHER PARTY.

 

8.2.           Warranties Disclaimer .     EXCEPT AS OTHERWISE SET FORTH HEREIN, (A) EACH PARTY ACKNOWLEDGES AND AGREES THAT ALL INTELLECTUAL PROPERTY RIGHTS AND TECHNOLOGY LICENSED HEREUNDER ARE LICENSED WITHOUT ANY WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED OR STATUTORY, WITH RESPECT THERETO, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, ENFORCEABILITY OR NON-INFRINGEMENT, AND (b) no Party makes any warranty or representation that any manufacture, use, importation, offer for sale or sale of any product or service will be free from infringement of any Intellectual Property of any Third Party.

 

10
 

 

8.3.           Indemnification . HBIO shall, and shall cause the other members of the HBIO Group to, jointly and severally, indemnify, defend and hold harmless the HART Indemnitees from and against any and all Liabilities of the HART Indemnitees relating to Third-Party Claims that any of the Transferred Intellectual Property or the New HBIO Technology infringes upon or misappropriates the Intellectual Property of any Third Party. HART shall, and shall cause the other members of the HART Group to, jointly and severally, indemnify, defend and hold harmless the HBIO Indemnitees from and against any and all Liabilities of the HBIO Indemnitees relating to Third-Party Claims that any of the New HART Technology infringes upon or misappropriates the Intellectual Property of any Third Party. Any claims for indemnification pursuant to this Section 8.3 shall be made in accordance with the procedures set forth in Section 5.5 of the Separation and Distribution Agreement.

 

ARTICLE IX

 

COMPETITIVE RESTRICTIONS

 

9.1.           Non-Competition Covenants of HBIO . HBIO agrees that it will not, either directly or through any of its Affiliates or Subsidiaries, knowingly make, sell or have made or sold, or market or distribute, any pumps, syringes, bioreactors, scaffolds, machines, software, devices or other products that compete with the HART Business, subject to the following exceptions: (a) HBIO shall be permitted to use any Rejected New HBIO Technology in its own business, or to license such Rejected New HBIO Technology to a Third Party, in either case for use outside the scope of its business; (b) the exceptions outlined in Section 3.9 hereof in the event of an acquisition of HBIO or the Harvard Apparatus Research Business; and (c) the foregoing shall not prevent HBIO from selling products from the Harvard Apparatus Research Business to hospitals, clinics and other customers who validate, solely for internal human use and not for commercial sale, a research-use only product through their internal regulatory processes, provided that HBIO further agrees that it shall not market these products for human use, nor perform clinical trials or seek FDA or other regulatory approval for human use of these products. The foregoing shall not prevent HBIO from selling products from its businesses outside of the Harvard Apparatus Research Business into hospitals, clinics and other customers for human use or perform clinical trials or seek FDA or other regulatory approval for human use outside the HART Business.

 

9.2.           Non-Competition Covenants of HART . HART agrees that it will not, either directly or through any of its Affiliates or Subsidiaries, knowingly make or sell, or have made or sold, or market or distribute any products that are outside the HART Business or compete in any manner with the HBIO Group’s business, subject to the following exceptions: (a) HART shall not be prohibited from any natural expansion of its business if undertaken by comparable companies in the regenerative medicine field for use in humans, other than expansion in to the Harvard Apparatus Research Business; (b) HART shall be permitted to use any Rejected New HART Technology by HART in its own business, or to license such Rejected New HART Technology to a Third Party, in either case for use outside the scope of the HART Business; (c) the exceptions outlined in Section 4.9 hereof in the event of an acquisition of HART; and (d) HART may place products for use outside the scope of the HART Business at research sites, but only if there is no charge to the user for such products. For clarity since HART will operate in the HART Business and HBIO will operate in the Harvard Apparatus Research Business, it is permissible for both companies to be simultaneously selling an identical product under their respective trademarks in their respective separate fields of use (i.e. HART Business for HART and Harvard Apparatus Research Business for HBIO) without violating Article IX of this Agreement. Notwithstanding the foregoing, in order for HART to promote collaborations with leading scientists in regenerative medicine, HBIO acknowledge and agrees that it shall not violate the non-competition provisions described above if HART places products for use in the Harvard Apparatus Research Business at research sites, as long as there is no charge to the customer for such products. If the product placed for such purpose is manufactured by HBIO, HART will be entitled to purchase it from HBIO at discount rate of [***] off of HBIO’s then current US list price for such product. However, nothing in this paragraph shall obligate HART to purchase such products from HBIO.

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

11
 

 

9.3.           Non-Solicitation Covenants . Without the prior written consent of the other Party and except for those employees that the Parties have agreed, on or prior to the date hereof, will be employed by the HART Business commencing on the Distribution Date, each Party agrees that it shall not, (A) hire any of the other Party’s (or its subsidiaries’ or affiliates') employees, or (B) solicit, for the purpose of hiring (other than in the ordinary course of a hiring solicitation program), any of the other Party’s (or its subsidiaries’ or affiliates') employees. Nothing herein shall preclude generalized searches by a Party for employees through the use of advertisement in the media or through engagement of firms to conduct searches that are not targeted or focused on the other Party’s (or its subsidiaries’ or affiliates') employees or hiring (i) any person who responds to such advertisement or (ii) any person that was not indirectly or directly contacted or solicited in violation of the above provisions and who contacts a Party on his or her own behalf, or (iii) negotiating with or hiring any such person whose employment was terminated by a Party or any of its subsidiaries or affiliates prior to commencement of employment discussions between the other Party and such person. In the event of a sale of HBIO or HART, this Section 9.3 shall not be construed to prohibit the acquiring entity from soliciting or hiring employees of the other Party hereto, so long as such employees are not solicitated or hired by the acquired entity.

 

9.4.           Expiration of Obligations . The non-competition and non-solicitation covenants contained in this Article IX shall terminate and be of no further force and effect after the tenth anniversary of the Separation Date , provided that such covenants may be terminated immediately by either Party upon written notice in the event that an Insolvency Event occurs with respect to the other Party. However, in the event that either HART or HBIO abandons any particular product or products, it shall so notify the other Party in writing within sixty (60) days thereof, at which time the non-competition covenants of this Article IX shall expire, terminate and be of no further force and effect with respect to such abandon product or products. For purposes of this Agreement, a Party will be deemed to have abandoned a product or products if it is no longer actively involved in developing, marketing, selling or distributing such product or products.

 

9.5.           Impact on Certain Strategic Transactions by HBIO . The non-competition provisions in this Article IX shall not prevent the sale of HBIO to an entity that is engaged in business activities that are competitive with those of the HART Business, provided, however, that in the event of such a sale, while the acquiring entity may compete with the HART Business, it shall not directly or indirectly use any of HART’s Information, that is subject to confidentiality in accordance with Section 7.8 of the Separation and Distribution Agreement, in any manner that competes with the HART Business. In addition, in the event that HBIO, through its Harvard Apparatus Research Business, acquires a business that has products in the HART Business, it shall so notify HART in writing within ten (10) days of the effective date of such acquisition. Upon the receipt of such notice, HART shall have sixty (60) days to elect to either: (a) acquire that limited portion of the acquired business with the products in the HART Business, at a price determined by an independent, duly-qualified Third Party appraiser mutually selected by HART and HBIO; or (b) obtain an exclusive (only with respect to the HART Business) license to those products and/or become the exclusive (only with respect the HART Business) distributor for those products on terms and conditions mutually agreed-upon by the Parties.

 

9.6.           Impact on Certain Strategic Transactions by HART . The non-competition provisions set forth in this Article IX shall not prevent the sale of HART to an entity that is engaged in business activities that are competitive with those of the HBIO Group , provided, however, that in the event of such a sale, while the acquiring entity may compete with the HBIO Group’s business, it shall not directly or indirectly use any of the HBIO Group’s Information, that is subject to confidentiality in accordance with Section 7.8 of the Separation and Distribution Agreement, in any manner that competes with the HBIO Group’s business. In addition, in the event that HART acquires a business that that has products outside of the HART Business, it shall so notify HBIO in writing within ten (10) days of the effective date of such acquisition. Upon the receipt of such notice, HBIO shall have sixty (60) days to elect to either: (a) acquire that limited portion of the acquired business with the products in the HBIO Group’s business, at a price determined by an independent, duly-qualified Third Party appraiser mutually selected by HBIO and HART; or (B) obtain an exclusive (only with respect to the HBIO Group’s business) license to those products and/or become the exclusive (only with respect to the HBIO Group’s business) distributor for those products on terms and conditions mutually agreed-upon by the Parties.

 

12
 

 

ARTICLE X

 

MISCELLANEOUS

 

10.1.           Term and Termination . The transfer of the Transferred Intellectual Property shall remain in effect in perpetuity. Unless otherwise explicated stated herein and subject to the termination rights with respect to specific license grants set forth herein, the licenses granted under this Agreement shall remain in effect in perpetuity. The Parties acknowledge that the licenses granted hereunder are intended to be licenses of “Intellectual Property” as such term is used in Section 365(n) of the United States Bankruptcy Code and for other similar laws and that the licenses herein are given and received for fair and adequate value. Accordingly, the Parties intend (a) each of the Parties will have the benefit of any applicable law related to insolvency or bankruptcy that protects a licensee from disclaimer or other challenge of the licenses granted to the licensee, and (b) the licenses granted hereunder will survive any bankruptcy of either Party.

 

10.2.           Counterparts; Entire Agreement; Corporate Power . This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when one or more counterparts have been signed by each of the Parties and delivered (by facsimile, electronic transmission or otherwise) to the other Party. This Agreement, the exhibits, the schedules and appendices hereto and thereto, the Separation and Distribution Agreement (and Ancillary Agreements defined therein) contain the entire agreement between the Parties with respect to the subject matter hereof, supersede all previous agreements, negotiations, discussions, writings, understandings, commitments and conversations with respect to such subject matter and there are no agreements or understandings between the Parties other than those set forth or referred to herein or therein. Each Party hereto acknowledges that it and each other Party hereto is this Agreement by facsimile, stamp or mechanical signature. Each Party hereto expressly adopts and confirms each such facsimile, stamp or mechanical signature made in its respective name as if it were a manual signature, agrees that it will not assert that any such signature is not adequate to bind such Party to the same extent as if it were signed manually and agrees that at the reasonable request of any other Party hereto at any time it will as promptly as reasonably practicable the Agreement to be manually executed (any such execution to be as of the date of the initial date thereof).

 

10.3.           Governing Law, Jurisdiction and Dispute Resolution . This Agreement and any claims or disputes arising out of or related hereto or thereto or to the transactions contemplated hereby and thereby or to the inducement of any Party to enter herein and therein, whether for breach of contract, tortious conduct or otherwise and whether predicated on common law, statute or otherwise shall be governed by and construed and interpreted in accordance with the Laws of the Commonwealth of Massachusetts irrespective of the choice of laws principles of the Commonwealth of Massachusetts as to all matters, including matters of validity, construction, effect, enforceability, performance and remedies. If any dispute arises out of or in connection with this Agreement, except as expressly contemplated by another provision of this Agreement, the parties irrevocably (a) consent and submit to the exclusive jurisdiction of federal and state courts located in Boston, Massachusetts, and (b) waive any objection to that choice of forum based on venue or to the effect that the forum is not convenient. Notwithstanding the foregoing, any dispute arising out of or related to this Agreement shall be resolved in accordance with the procedures set forth in Section 9.1 of the Separation and Distribution Agreement. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

 

10.4.           Assignability . This Agreement shall be binding upon and inure to the benefit of the Parties hereto and thereto, respectively, and their respective successors and permitted assigns; provided, however, that no Party hereto or thereto may assign its respective rights or delegate its respective obligations under this Agreement without the express prior written consent of the other Party hereto or thereto (which consent may be withheld in such Party's sole and absolute discretion) and any assignment or attempted assignment in violation of the foregoing will be null and void. Notwithstanding the preceding sentence, and subject to the restrictions contained in Sections 9.5 and 9.6 hereof, a Party may assign this Agreement in connection with a merger transaction in which such Party is not the surviving entity or the sale by such Party of all or substantially all of its Assets, and upon the effectiveness of such assignment the assigning Party shall be released from all of its obligations under this Agreement if the surviving entity of such merger or the transferee of such Assets shall agree in writing, in form and substance reasonably satisfactory to the other Party, to be bound by all terms of this Agreement as if named as a “Party” hereto.

 

13
 

 

10.5.           Third-Party Beneficiaries . Except for the indemnification rights under this Agreement of any HBIO Indemnitee or HART Indemnitee in their respective capacities as such, (i) the provisions of this Agreement are solely for the benefit of the Parties and are not intended to confer upon any Person except the Parties any rights or remedies hereunder, and (ii) there are no third-party beneficiaries of this Agreement and this Agreement shall not provide any third Person with any remedy, claim, liability, reimbursement, claim of action or other right in excess of those existing without reference to this Agreement.

 

10.6.           Notices . All notices, requests, claims, demands or other communications under this Agreement shall be in writing and shall be given or made (and shall be deemed to have been duly given or made upon receipt) by delivery in person, by overnight courier service, by facsimile or electronic transmission with receipt confirmed (followed by delivery of an original via overnight courier service) or by registered or certified mail (postage prepaid, return receipt requested) to the respective Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 10.6:

 

If to HBIO to:
 
  Harvard Bioscience, Inc.
 

84 October Hill Road
Holliston, Massachusetts 01746

Attn: Chief Executive Officer

 
  with a copy (which copy will not constitute notice) to:
 
  Burns & Levinson LLP
  125 Summer Street
  Boston, MA 02110
  Attention:     Josef B. Volman
  Facsimile:    (617) 345-3299
 
If to HART to:
 
 

Harvard Apparatus Regenerative Technology, Inc.

84 October Hill Road
Holliston, Massachusetts 01746

Attn: Chief Executive Officer

 

 

with a copy (which copy will not constitute notice) to:

 
  Feinberg Hanson LLP
  57 River Street, Suite 204
  Wellesley, Massachusetts 02481
  Attention:    Harry A. Hanson, III
  Facsimile:    (781) 283-5776

 

Any Party may, by notice to the other Party, change the address to which such notices are to be given.

 

10.7.           Severability . If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, void or unenforceable, the remaining provisions hereof or thereof shall remain in full force and effect and shall in no way be affected, impaired or invalidated thereby. Upon such determination, the Parties shall negotiate in good faith in an effort to agree upon such a suitable and equitable provision to affect the original intent of the Parties.

 

14
 

 

10.8.           Force Majeure . No Party shall be deemed in default of this Agreement to the extent that any delay or failure in the performance of its obligations under this Agreement results from a Force Majeure. In the event of an occurrence of a Force Majeure, the Party whose performance is affected thereby shall give notice of suspension as soon as reasonably practicable to the other stating the date and extent of such suspension and the cause thereof, and such Party shall resume the performance of such obligations as soon as reasonably practicable after the removal of such cause.

 

10.9.           Expenses . Except as expressly set forth in this Agreement, all fees, costs and expenses incurred in connection with the preparation, execution, delivery and implementation of this Agreement, and with the consummation of the transactions contemplated hereby and thereby, will be borne by the Party incurring such fees, costs or expenses.

 

10.10.          Headings . The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 

10.11.          Waivers of Default . Waiver by any Party of any default by the other Party of any provision of this Agreement shall not be deemed a waiver by the waiving Party of any subsequent or other default, nor shall it prejudice the rights of the other Party. No failure or delay by any Party in exercising any right, power or privilege under this Agreement shall operate as a waiver thereof nor shall a single or partial exercise thereof prejudice any other or further exercise thereof or the exercise of any other right, power or privilege.

 

10.12.          Specific Performance . Subject to the provisions of Section 10.3, in the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the Party or Parties who are, or are to be, thereby aggrieved shall have the right to specific performance and injunctive or other equitable relief in respect of its or their rights under this Agreement, in addition to any and all other rights and remedies at law or in equity, and all such rights and remedies shall be cumulative. The Parties agree that the remedies at law for any breach or threatened breach, including monetary damages, are inadequate compensation for any loss and that any defense in any action for specific performance that a remedy at law would be adequate is waived. Any requirements for the securing or posting of any bond with such remedy are waived by each of the Parties to this Agreement.

 

10.13.          Amendments . No provisions of this Agreement shall be deemed waived, amended, supplemented or modified by any Party, unless such waiver, amendment, supplement or modification is in writing and signed by the authorized representative of the Party against whom it is sought to enforce such waiver, amendment, supplement or modification.

 

10.14.          Interpretation . In this Agreement, (a) words in the singular shall be held to include the plural and vice versa and words of one gender shall be held to include the other genders as the context requires; (b) the terms “hereof,” “herein,” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole (including all of the Exhibits hereto) and not to any particular provision of this Agreement; (c) Article, Section, and Exhibit references are to the Articles, Sections, and Exhibits to this Agreement unless otherwise specified; (d) the word “including” and words of similar import when used in this Agreement shall mean “including, without limitation,” (e) the word “or” shall not be exclusive; (f) unless expressly stated to the contrary in this Agreement, all references to “the date hereof,” “the date of this Agreement,” “hereby” and “hereupon” and words of similar import shall all be references to [ ], 2013, regardless of any amendment or restatement hereof.

 

[Signatures on following page]

 

15
 

 

IN WITNESS WHEREOF, the Parties have caused this Intellectual Property Matters Agreement to be duly executed as of the date first above written.

 

    HARVARD BIOSCIENCE, INC.
   
By:
 
     

Name:
Title:

 

    HARVARD APPARATUS REGENERATIVE
TECHNOLOGY, INC.
   
By:
 
     

Name:
Title:

 

 
 

 

 

Exhibit A

 

Patent/Technology   Jurisdiction   Expiration
         
Patent application covering aspects of syringe devices and methods for delivering cells to tissues   Europe, U.S.   2030
         
Patent application covering aspects of clinical scale bioreactors and tissue engineering   Australia, Europe, Japan, Russia, U.S.   2030
         
Issued Patent covering aspects of liquid distribution in a rotating bioreactor   Germany   2031
         
Patent application covering aspects of liquid distribution in a rotating bioreactor   PCT – international stage   2032
         
Patent application covering aspects of synthetic scaffolds and organ and tissue transplantation   PCT – international stage   2032
         
Patent application covering aspects of synthetic scaffolds and organ and tissue transplantation   U.S.   2032
         
Provisional patent applications relating to infrared-based methods for evaluating tissue health including methods for evaluating burns   U.S.   N/A
         
Provisional patent applications relating to methods and compositions for producing elastic scaffolds for use in tissue engineering   U.S.   N/A
         
Provisional patent applications relating to support configurations for tubular tissue scaffolds, and airway scaffold configurations   U.S.   N/A
         
Provisional patent application relating to methods and compositions for promoting the structural integrity of nanofiber-based scaffolds for tissue engineering   U.S.   N/A
         
Provisional patent application relating to synthetic airways   U.S.   N/A

 

 
 

  

Exhibit B

 

Transferred Licenses

 

1. Exclusive License Agreement dated August 6, 2009 by and between Harvard Bioscience, Inc. and Sara Mantero and Maria Adelaide Asnaghi

 

2. IPR Assignment Agreement dated April 24, 2012 by between Harvard Bioscience Inc. and CMA Microdialysis AB

 

3. Intellectual Property Assignment, License and Services Agreement dated March 8, 2012 by and among Mammalian Cell Technologies, LP, Michael C. Riddle, and Harvard Bioscience, Inc.

 

4. Non-Exclusive Patent License Agreement dated April 9, 2012 by and between The General Hospital Corporation, d/b/a Massachusetts General Hospital, and Harvard Bioscience, Inc.

 

 

 

EXHIBIT 10.18

 

patent RIGHTS ASSIGNMENT

 

THIS PATENT RIGHTS ASSIGNMENT (“ Patent Assignment ”) is made, entered into and effective as of this 21st day of December, 2012, by PAOLO MACCHIARINI, an individual, c/o Karolinska Institutet, SE-171, 77 Stockholm, Sweden, (the “ Assignor ”) in favor of HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. , a Delaware corporation (the “ Assignee ”).

 

recitals:

 

WHEREAS , the Assignor has agreed to assign to the Assignee all of its right, title and interest in, and to execute this Patent Assignment to enable Assignee to acquire all of his rights to certain inventions and the patent application and all divisions, reissues, reexaminations, substitutions, continuations, continuations-in-part, foreign counterparts and extensions of the patent applications listed on Schedule 1 (collectively, the “ Assigned Patent Rights ”).

 

NOW, THEREFORE , in consideration of the foregoing and the respective representations, warranties, covenants, agreements and conditions set forth herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, each party hereto hereby agrees as follows:

 

1.           Assignment . The Assignor hereby irrevocably conveys, transfers and assigns to the Assignee, and the Assignee hereby accepts, all Assignor’s legal and beneficial right, title and interest, if any, of the Assignor in and to the Assigned Patent Rights, and the inventions claimed therein, to hold unto Assignee absolutely and in perpetuity (or for the longest period of time otherwise permitted by law), together with all related common-law rights associated therewith and any and all royalties, fees, income, payments and other proceeds now or hereafter due or payable with respect thereto and all causes of action and rights to sue, seek injunctive relief, and recover (for the sole use and benefit of the Assignee and its successors, assigns or other legal representatives) damages for past, present and future infringement, misappropriation or other violation thereof or damage thereto . The Assignee is to hold all right, title and interest in and to the Assigned Patent Rights as fully as it would have been held and enjoyed by the Assignor, to the end of the term or terms for which said Patent is or may be granted, reissued, renewed, restored, amended, converted, or extended, had the assignment in this Section 1 not been made.

 

2.           Authorization . The Assignor authorizes and requests the United States Patent and Trademark Office and the equivalent office in each country or international entity in which Assigned Patent Rights is registered to record the Assignee as the assignee of the rights of Assignor in the Assigned Patent Rights and to issue any patents which may be granted on any applications included in the Assigned Patent Rights to the Assignee as assignee of the entire right, title and interest therein and thereto.

 

 
 

 

3.           Further Assurances . Each party hereto shall, from time to time and at all times hereafter, upon the request of the other party hereto, do, execute, acknowledge and deliver or cause to be done, executed, acknowledged and delivered all such further acts, deeds, assignments, transfers, conveyances, powers of attorney and assurances as may be required to carry out the intent of this Patent Assignment. Without limiting the foregoing, the Assignor agrees, without additional consideration, to take such further actions and to execute any powers of attorney, applications, assignments, declarations, affidavits and other papers necessary or desirable to transfer, vest, record and perfect good, valid and marketable title in the Assigned Patent Rights to the Assignee.

 

4.           Entire Agreement . This Patent Assignment contains the entire agreement of the parties with regard to the subject matter hereof; provided , however , that this provision is not intended to abrogate any other written agreement between the parties executed with or after this Patent Assignment.

 

5.           Successors and Assigns . This Patent Assignment shall be binding upon each party hereto and its respective successors and assigns.

 

6.           Governing Law . This Patent Assignment shall be governed by and construed in accordance with the Laws of the State of Delaware without giving effect to any Law or rule that would cause the Laws of any jurisdiction other than the State of Delaware to be applied.

 

7.           Counterparts . This Patent Assignment may be executed in multiple counterparts, each of which shall for all purposes be deemed to be an original and all of which, when taken together, shall constitute one and the same instrument. Signatures of the parties transmitted by electronic transmission shall be deemed to be their original signatures for all purposes .

 

(Signature on following page)

 

2
 

 

IN WITNESS WHEREOF , the parties hereto have caused this Patent Assignment to be duly executed effective as of the date first above written.

 

  ASSIGNOR ”:
   
  PAOLO MACCHIARINI
   
  /s/ Paolo Macchiarini
   
  ASSIGNEE ”:
   
  HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
   
  By: /s/ David Green
       David Green, President and CEO

 

 
 

 

Schedule 1

 

assigned Patent APPLICATION

 

Country   Application Number   Status   Filing Date
             
United States   61/505,096   Provisional   July 6, 2011
             
United States   13/542,218   Pending   July 5, 2012
             
United States   13/542,202   Pending   July 5, 2012
             
PCT   PCT/IB2012/001696   Pending   July 6, 2012

 

 

 

 

EXHIBIT 10.19

 

CONFIDENTIAL TREATMENT REQUESTED

 

The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934 as amended.

 

REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***].

 

EXCLUSIVE LICENSE AGREEMENT

 

This EXCLUSIVE LICENSE AGREEMENT (this " Agreement ") is entered into as of the last date below written (the " Effective Date "), by and between SARA MANTERO, Ph.D . (" Mantero "); MARIA ADELAIDE ASNAGHI (" Asnaghi ") (Mantero and Asnaghi are collectively referred to herein as " Licensor "); HARVARD BIOSCIENCE, INC ., a Delaware corporation (" Licensee ").

 

Recitals:

 

A.   Licensor is the inventor of certain processes and devices that allow for the migration of organic cells into tissue samples while being incubated in a specialized bioreactor (the " Technology ").

 

B.   The Technology has proven beneficial medical uses in organ transplant as well as the potential for use in other areas.

 

C.   Subject to the terms of this Agreement, Licensee desires to obtain a license from Licensor and Licensor desires to provide to Licensee an exclusive license to make, use, have made, sell, offer to sell, import, manufacture, market and distribute the Technology and related improvements.

 

THEREFORE, for good and valuable consideration, the receipt and adequacy of which is hereby recognized by the parties, the parties agree as follows:

 

ARTICLE: 1

DEFINITIONS

 

1.1          " Affiliate " means any entity controlled by, under common control with, or controlling Licensee through voting stock or its board of directors or other supervisory board.

 

1.2          " Authorized Person " means Licensee's or its Affiliate's employees, officers, legal counsel, members of Licensee's board of directors or supervisory board, and independent contractors, each of whom Licensee shall have obtained a written agreement from to comply with the obligations of Licensee under this Agreement.

 

Execution Version

Exclusive License Agreement 

Page 1
 

 

1.3          " Confidential Information " means any proprietary information of or regarding Licensor or Licensee, including the Know-How and any trade secrets included within the Improvements, and all other, techniques, inventions, ideas, and processes; any data or information relating to any work in process, or future development plans; and any engineering, manufacturing, marketing, servicing, financial or personnel matter or information relating to Licensor or Licensee in oral, written, graphic or electronic form. Confidential Information may also include information disclosed to a disclosing party by third parties. Confidential Information will not, however, include any information which:

 

(a)          was publicly known and made generally available in the public domain prior to the time of disclosure by the disclosing party;

  

(b)          becomes publicly known and made generally available after disclosure by the disclosing party to the receiving party through no action or inaction of the receiving party;

 

(c)          becomes publicly known as a result of having been included in a patent application relating to the Technology;

 

(d)          does not pertain to the Technology and is already in the possession of the receiving party at the time of disclosure by the disclosing party as shown by the receiving party's files and records immediately prior to the time of disclosure;

 

(e)          is obtained by the receiving party from a third party without a breach of such third party's obligations of confidentiality;

 

(f)          does not pertain to the Technology and is independently developed by the receiving party without use of or reference to the disclosing party's Confidential Information, as shown by documents or other competent evidence in the receiving party's possession; or

 

(g)          is required by law to be disclosed by the receiving party, provided that the receiving party gives the disclosing party prompt written notice of such requirement prior to such disclosure and assistance in obtaining an order protecting the information from public disclosure.

 

1.4          " Hardware " means any hardware or equipment owned by Licensor that is required to assemble, maintain or use the bioreactors associated with the Technology as of the Effective Date.

 

1.5          " Improvements " mean any Intellectual Property developed after the Effective Date by either Mantero or Asnaghi or any third party affiliated with Mantero or Asnaghi that constitutes an improvement or enhancement of the functions of the Technology, that is associated to the Technology and that relates :to a bioreactor device able to feed and repopulate a rotating tubular structure, with the exclusion of different or new functions relating to generation of electrical fields, pressure fields and fluid dynamic fields.

 

1.6          " Intellectual Property " means (a) all inventions (whether patentable or un-patentable and whether or not reduced to practice); all improvements thereto, and all patents, patent applications, and invention disclosures, together with all re-issuances, continuations, continuations-in-part, divisions, renewals, revisions, reissues, extensions and reexaminations thereof, (b) all works of authorship, all copyrights therein, and all applications, registrations, and renewals in connection therewith, (c) all know-how and trade secrets; (d) all software in source or object code form; and (e) all copies and tangible embodiments of the foregoing (in whatever form or medium).

 

Execution Version

Exclusive License Agreement 

Page 2
 

 

1.7          " Know-How " means any and all technical data, user guidelines, protocols, trade secrets, drawings, information, knowledge and other Intellectual Property that relates to the Technology or the manufacture, marketing, registration, purity, quality, potency, safety or efficacy of the Technology.

 

1.8          " Licensed Processes " means any processes that relate to the Know-How.

 

1.9          " Licensed Products " means any bioreactors included within the Know-How.

 

1.10        “ Licensed Services " means any services whereby a Licensed Process is performed for another.

 

1.11        " Licensed Technology " means the Know-How, Licensed Processes, Licensed Products, Licensed Services, Patent Rights and/or Improvements.

 

1.12        " Patent Rights " mean all of the following:

 

(a)          any United States and/or foreign patents and/or patent applications related to the Technology or Improvements in which either Mantero or Asnaghi is listed as an inventor;

 

(b)          United States and foreign patents issued from the applications described in (a) and/or from divisionals and continuations of these applications;

 

(c)          United States continuation in part applications and foreign continuation in part applications, and the resulting patents, based on the United States and/or foreign applications described in (a);

 

(d)          claims of all foreign patent applications, and of the resulting patents, which are directed to subject matter specifically described in the United States patents and/or applications described in (a), (b) or (c) above; and

 

(e)          any reissues of patents described in (a), (b), (c) or (d) above.

 

1.13         " Recipient " means the party who receives Confidential Information under this Agreement, including Authorized Persons.

 

1.14         " Territory " means world-wide and everywhere.

  

ARTICLE: 2

LICENSE GRANT

 

2.1           License . Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee an exclusive, perpetual and irrevocable license to make, use, have made, sell, offer to sell, import, manufacture, market and distribute the Licensed Technology within the Territory. Licensee shall appoint the company SKE S.r.l. as exclusive distributor of the Licensed Technology in Italy at the conditions to be separately agreed between the parties.

 

Execution Version

Exclusive License Agreement

Page 3
 

 

2.2           Sublicenses . Licensee will have the right to grant one or more sublicenses under this Agreement without the prior written consent of Licensor.

 

2.3           Reservation of Rights . Licensor reserves the right to practice the Patent Rights and further develop the Technology for its own non-commercial research purposes. Licensor will not have the right to grant sublicenses of these rights without the prior written consent of Licensee.

 

2.4           Know-How and Hardware Transfer . Licensor will provide Licensee with access to all Know-Flow existing and as may be developed from time to time. In addition, Licensor will provide Licensee with access to the actual rotating bioreactor used in, and all data related thereto, the engineered airway transplantation. Licensor hereby assigns, transfers and conveys to Licensee all of Licensor's interests in and to the Hardware.

 

2.5           License to Use Names . Licensee is hereby granted the world-wide, perpetual and irrevocable right to disclose and use the names of Licensor and University in connection with promoting, advertising, marketing, licensing and/or selling Licensed Products and products that were formerly Licensed Products, as long as such disclosure and usage accurately describes their involvement in the development of the Licensed Technology,

 

ARTICLE: 3

TERM AND TERMINATION

 

3.1           Termination . This Agreement will terminate upon the later of: a) the date of the last to expire of any Patent Rights, or b) seven (7) years from the Effective Date if no Patent Rights are in existence as of such date.

 

3.2           Failure to Pay Royalties . If Licensee fails to pay Licensor any royalties due and payable under this Agreement, then Licensor may terminate this Agreement upon ninety (90) days prior written notice unless Licensee pays Licensor within the ninety (90) day period all such uncontested royalties and interest due and payable. Upon the expiration of the ninety (90) day period, if Licensee has not paid all such royalties and interest due and payable, the rights, privileges and licenses granted to Licensee under this Agreement will immediately terminate.

 

3.3           Effects of Termination . Termination of this Agreement, for whatever reason, will not affect any rights of either party that have accrued prior to the termination of this Agreement, though no additional rights will accrue following the termination. If this Agreement is terminated as a result of Licensor's breach, then Licensor will be deemed to have forfeited and assigned to Licensee all right, title and interest in and to the Licensed Technology and Licensor hereby grants Licensee the power of attorney to execute such documents as may be required to effectuate such assignment of the Licensed Technology as Licensee deems appropriate.

 

ARTICLE: 4

ROYALTIES

 

4.1           Marketing and Sales Efforts . Licensee agrees to use commercially reasonable efforts to market and sell Licensed Products.

 

Execution Version

Exclusive License Agreement 

Page 4
 

 

4.2           Royalty Payment . For the rights, privileges and licenses granted hereunder, Licensee shall pay to Licensor the royalties described in Exhibit A .

 

4.3           Payments and Reports .

 

(a)          Licensee, within forty-five (45) days after June 30 and December 31 of each year, will deliver to Licensor true and accurate reports, giving-such particulars of the business conducted by Licensee during the preceding six-month period under this Agreement as shall be pertinent to a royalty accounting under this Agreement.

 

(b)          With each such report submitted, Licensee shall pay to Licensor the royalties due and payable under this Agreement. If no royalties are due, Licensee will state this in writing within such time period.

 

4.4           Products to University . Licensee will provide University with Licensed Products for research use only at University at a price equal to Licensee's cost, plus twenty (20%) percent. The parties acknowledge that no royalties will be paid to Licensor with respect to such sales to University. In addition, Licensee will provide University with up to three (3) Licensed Products, without charge, to be used for research purposes only at University. University agrees not to resell any Licensed Products that it received from Licensee.

 

ARTICLE: 5

TRADEMARKS

 

5.1           Acknowledgement . Licensor acknowledges that Licensee will have the authority to market the Licensed Technology under any trademarks that it desires. Licensor acknowledges Licensee's sole right, title and interest in and to any such trademarks and agrees not to claim any title or interest in such trademarks or any right to use the trademarks except as may be permitted by Licensee in writing.

 

5.2           Variations . Licensor will not at any time permit the adoption or use, without Licensee's prior written consent, of any variation of any trademarks likely to be confused with or similar to any trademarks used by Licensee to market the Licensed Technology. If Licensee consents to any such variation, then Licensor agrees that Licensee will own such new mark.

 

5.3           Future Cooperation . Licensor will, during and after the term of this Agreement, execute such documents as Licensee may request from time-to-time to ensure that all right, title and interest in and to the trademarks used in association with the marketing of the Licensed Technology reside and remain with Licensee or any other entity determined by Licensee.

 

ARTICLE: 6

WARRANTIES

 

6.1           Warranties . Licensor represents and warrants to Licensee that:

 

Execution Version

Exclusive License Agreement 

Page 5
 

 

(a)          Licensor has the sole, exclusive arid unencumbered right to grant the licenses and rights granted in this Agreement to Licensee;

 

(b)          there are no other agreements with any third parties that relate to the Licensed Technology that would conflict with the rights granted by this Agreement;

 

(c)          to the best of Licensor's knowledge, the Licensed Technology does not in any way infringe upon any intellectual property rights of any third party;

 

(d)          to the best of Licensor's knowledge, no governmental or other third party authorizations, permits or licenses are required to use or sell the Licensed Technology; and

 

(e)          Licensor will not assign any interests in any Improvements to any third party or otherwise take any actions to encumber Licensee's interest in the Technology or Improvements as granted by this Agreement.

 

6.2           Technology Information and Access . Upon request by Licensee from time-to-time, Licensor will, within a reasonable period of time thereafter not later than thirty (30) days after such request, deliver to Licensee copies of reasonable documentation describing the Licensed Technology as it is reasonably related to the scope of Licensee's efforts to market or sell the Licensed Technology. Licensor grants Licensee the rights to copy; modify, distribute and create derivative works from any such documentation. Licensor will give access to and use reasonable efforts to keep Licensee appraised of, all ongoing and future Licensed Technology created by Licensor. Licensor will reasonably cooperate with and provide advice to Licensee with respect to the implementation of the Licensed Technology. Licensor will at all times provide Licensee with access to Licensor's patent applications related to the Licensed Technology and notify Licensee when any patents issue thereon.

 

6.3           Indemnification . Licensor will indemnify and hold harmless Licensee and its respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including actual attorneys' fees and expenses) incurred or sustained by Licensee arising out of or in connection with any fraudulent or grossly negligent breach of any representation, covenant, warranty or obligation of Licensor under this Agreement.

 

ARTICLE: 7

LICENSED INTELLECTUAL PROPERTY RIGHTS ENFORCEMENT

 

7.1           Infringement by Third Parties . Licensor will notify Licensee promptly of any infringement or unauthorized use of the Licensed Technology by others of which Licensor becomes aware. Licensee will have the sole right, at its expense, to bring any action on account of any infringement or unauthorized use of the Licensed Technology of which it becomes aware, and Licensor will cooperate with Licensee, as Licensee may request, at Licensee's expense, in connection with any such action brought by Licensee. Licensee will retain any and all damages, settlement and/or compensation paid in connection with any such action brought by Licensee.

 

Execution Version

Exclusive License Agreement  

Page 6
 

 

Licensor hereby assigns to Licensee any and all causes of action Licensor may have for any past, present or future infringement of any rights associated with the Licensed Technology.

 

7.2           Defending Against Claims by Third Parties . Licensee will have the sole right, at its expense, to defend and settle for other than money damages any action that may be commenced against Licensee or Licensor alleging that the Licensed Technology infringes any rights of third parties. If Licensee does not give notice to Licensor of its intent to defend or settle such action within thirty (30) calendar days after notice from Licensor of such alleged infringement, Licensor may defend the action, at its expense, provided that no settlement will be made without the prior written approval of Licensee and Licensor will advise Licensee periodically of the status of the action and promptly of any material developments. Licensee reserves the right to participate at any time in such proceedings.

 

7.3           Patent Maintenance . Licensee, at Licensee's sole expense, will have the sole and exclusive right, in Licensee's sole and absolute discretion, to apply for, prosecute, or cause the issuance, amendment, abandonment, maintenance, re-examination or reissue of any patents included in the Licensed Technology.

 

7.4           Cooperation . Licensor further covenants and agrees that it shall, at any time, upon Licensee's request and at Licensee's expense, testify in any legal proceeding, execute and deliver any agreement, document, certificate or instrument and generally do all that is possible or that Licensee deems may be necessary or desirable to secure or maintain the protection of the Intellectual Property associated with the Licensed Technology.

 

ARTICLE: 8

CONFIDENTIALITY

 

8.1           Non-Use and Non-Disclosure . Neither party shall use any Confidential Information except to exercise its rights and perform its obligations under this Agreement. Neither party shall disclose any Confidential Information of the other party to third parties or to such party's employees, except to those employees of the receiving party with a need to know. Notwithstanding the above; either party may disclose information on a "need-to-know" basis to potential business associates with the approval of the other party, which will not be unreasonably withheld.

 

8.2           Maintenance of Confidentiality . Each party shall take reasonable measures to protect the secrecy of and avoid disclosure and unauthorized use of the Confidential Information of the other party and of any Confidential Information associated with any trade secrets included within the Licensed Technology. Without limiting the foregoing, each party shall take at least those measures that it takes to protect its own most highly confidential information.

 

8.3           Permitted Disclosures . Nothing in this Agreement will prevent Licensee from disclosing any information, including Confidential Information, in any patent application or related document it may elect to file. Recipient may only disclose the Confidential Information to an Authorized Person.

 

Execution Version

Exclusive License Agreement  

Page 7
 

 

ARTICLE: 9

NOT A FRANCHISE AGREEMENT

 

LICENSEE AND LICENSOR AGREE THAT THIS AGREEMENT IS NOT A FRANCHISE AGREEMENT, AS SUCH AGREEMENTS ARE DEFINED UNDER THE STATUTES AND REGULATIONS OF THE UNITED STATES AND APPLICABLE STATE LAW, AND THEREFORE THAT THIS AGREEMENT IS NOT SUBJECT TO THOSE STATUTES AND REGULATIONS. LICENSEE AND LICENSOR FURTHER AGREE THAT EACH WILL EXECUTE ANY DOCUMENTS AND GIVE ANY TESTIMONY WHICH IS NECESSARY TO AVOID HAVING THIS AGREEMENT CONSTRUED AS A FRANCHISE AGREEMENT,

 

ARTICLE: 10

JURISDICTION AND DISPUTES

 

10.1         Choice of Law . The rights and obligations of the parties under this Agreement shall be governed by the laws of Italy.

 

10.2         Disputes . In the event of any dispute, controversy or claim arising out of or relating to this Agreement, or to the breach or termination hereof (a " Dispute "), the parties agree to resolve the same as follows:

 

(a)          The parties to the Dispute shall initially attempt to resolve it through consultations and negotiations.

 

(b)          If the Dispute has not been resolved amicably within thirty (30) days after any party provides notice thereof, unless the parties agree otherwise, the Dispute shall be resolved by a single arbitrator in a final and binding arbitration that will be conducted in Milan, Italy in accordance with the Arbitration Rules of the Chamber of Commerce of Milan, as in effect on the Effective Date (the " Milan Rules "). The International Centre for Dispute Resolution (" ICDR ") shall serve as the appointing authority. If the parties cannot agree on the arbitrator then an arbitrator experienced in matters similar to the Dispute will be chosen by ICDR. The language to be used in the arbitration proceeding shall be English. The arbitration shall be administered by the ICDR under the Milan Rules. The arbitrator shall render a written award stating the reasons for the decision. An arbitration award or decision may be entered by any court of competent jurisdiction, or application may be made to such a court for judicial acceptance of the award or decision and any appropriate order, including enforcement. All direct costs of an arbitration proceeding under this Section, including fees and expenses of arbitration, shall be borne equally by the parties hereto. All other costs, including counsel and witness fees, shall be borne by the party incurring them.

 

(c)          Each of the parties hereto consents to the submission of any Dispute for settlement by final and binding arbitration in accordance with paragraph (b) above. Such consent shall satisfy the requirements for an "agreement in writing" pursuant to Article II of the United Nations Convention on the Recognition and Enforcement of Foreign Arbitration Awards, done at New York on June 10, 1958.

 

Execution Version

Exclusive License Agreement 

Page 8
 

 

(d)          Each of the parties hereby undertakes to carry out without delay the provisions of any arbitration award or decision.

 

ARTICLE: 11

GENERAL PROVISIONS

 

11.1           Integration . With respect to the subject matter of this Agreement, this Agreement constitutes the entire understanding between the parties and supersedes any prior discussions, negotiations, agreements and understandings.

 

11.2           Notice . All notices and other communications required or permitted under this Agreement will be in writing and will be deemed given when delivered personally or by registered or certified mail, return receipt requested, addressed as follows (or any other address that is specified in writing by either party):

 

To Licensor:

 

Sara Mantero
Dipartimento di Bioingegneria
Politecnico di Milano
Via Golgi 39 (Ed.34 - piano IV)
20133 Milan
Italy

 

Maria Adelaide Asnaghi
Via Piave 54
20036 Meda (MI)
Italy

 

To Licensee:

 

Harvard Bioscience, Inc.
84 October Hill Road
Holliston, Massachusetts 01746
United States of America

 

With a copy to:

 

Jaffe, Raitt, Heuer & Weiss, P.C.
Attn: Sara M. Kruse, Esq.
27777 Franklin Rd., Suite 2500
Southfield, Michigan 48034
United States of America

 

11.3           Severability . Whenever possible, each provision of this Agreement will be interpreted in such a way as to be effective and valid under applicable law. If a provision is prohibited by or invalid under applicable law, it will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

Execution Version

Exclusive License Agreement 

Page 9
 

  

11.4           Assignments . No assignment of this Agreement or of any right or obligation under this Agreement will be made by Licensor or by Licensee without the prior written consent of the other party, such consent not to be unreasonably withheld. Further, Licensee may assign its rights under the Agreement without the prior written consent of Licensor so long as Licensee remains responsible for any obligations in respect of this Agreement.

 

11.5           Waiver . Either party's failure to exercise a right or remedy will not operate as a waiver of any of such party's rights or remedies or the other party's obligations under this Agreement and will not constitute a waiver of its right to declare an immediate or a subsequent default.

 

11.6           Amendments . The terms of this Agreement may not be varied or modified in any manner, except in a subsequent writing executed by an authorized representative of both parties.

 

11.7           Independent Contractors . In its relationship under this Agreement, each party is an independent contractor. Nothing in this Agreement on its own will be construed such that

 

11.8           Survival . The following will survive the termination of this Agreement: Articles 1, 5, 8, 9, 10 and 11 and Sections 2.5, 3.3 and 6.3.

 

11.9           Counterparts . This Agreement may be executed in one or more counterparts, each of which will be deemed an original agreement, but all of which will be considered one instrument and will become a binding agreement when one or more counterparts have been signed by each of the parties and delivered to the other. A facsimile of this document bearing a party's signature or a printed copy of the original, signed document scanned in .pdf or .tif format will have the same legal force and effect as an, original of Such signature and will be treated as an original document for evidentiary purposes.

 

11.10           Force Majeure . Neither party will be deemed to be in default or otherwise responsible for delays or failures in performance resulting from acts of God, acts of war or civil disturbance, epidemics, governmental action or inaction, fires, earthquakes, unavailability of labor, materials, power or communication, or other causes beyond their reasonable control.

 

11.11           No Third-Party Beneficiaries . This Agreement will not confer any rights or remedies upon any third-party, other than the parties to this Agreement and their respective successors and permitted assigns.

 

11.12           Titles . Titles and headings to Sections in this Agreement are inserted for convenience of reference only and are not intended to affect the interpretation or construction of the Agreement.

 

11.13           Ambiguity Not to Be Construed Against Drafter . Each party to this Agreement has been involved in its drafting and negotiation. No rule of law that ambiguity in an agreement will be construed against the drafter will be applied in interpreting this Agreement.

 

[SIGNATURES ON NEXT PAGE]

 

Execution Version

Exclusive License Agreement 

Page 10
 

 

Agreed as of the date last below written:    
     
Licensor:   Licensee:
     
Mantero:   HARVARD BIOSCIENCE, INC.,
    a Delaware corporation
     
By: /s/ Sara Mantero   By: /s/ David Green
  SARA MANTERO, Ph.D.    
    Print Name: David Green
     
Dated:     Its: President
     
Asnaghi:   Dated: 5 th August, 2009
     
     
By: /s/ Maria Adelaide Asnaghi    
  MARIA ADELAIDE ASNAGHI    
     
Dated: 6 th Aug 2009    

 

Execution Version

Exclusive License Agreement 

Page 11
 

 

Exhibit A

 

Royalties

 

1.          Within ten (10) days from the Effective Date, Licensee will pay Licensor [***] United States Dollars.

 

2.          For any Licensed Products that shall be sold in the [***] from the Effective Date and that are not then protected under any Patent Rights, Licensee will pay Licensor [***] percent of Licensee's Net Sales of such Licensed Products. If this Agreement terminates during the [***] period where royalties on a particular Licensed Product are required to be paid under this Section 2, then the obligation to pay royalties with respect to such Licensed Product only will continue until the completion of the [***] for which royalties would have otherwise been required to be paid but for the termination of this Agreement,

 

3.          For any Licensed Products that are then protected under any Patent Rights, Licensee will pay Licensor [***] percent of Licensee's Net Sales of such Licensed Products for the life of the patent.

 

4.          Until the date that is [***] from the Effective Date, Licensee will pay Licensor [***] percent of Licensee's Net Sales from any products that simultaneously meet all of the following criteria (" Inspired Products "): 1) the products are not Licensed Products, 2) the products were developed by Licensee following the Effective Date, and 3) the products, in Licensee's and Licensor's opinion, implement the working principles of the Licensed Products, If this Agreement terminates during the [***] period where royalties on a particular Inspired Product are required to be paid under this Section 4, then the obligation to pay royalties with respect to such Inspired Product only will continue until the completion of the [***] period for which royalties would have otherwise been required to be paid but for the termination of this Agreement.

 

5.          For purposes of clarity, royalties on the sale of a single product cannot be payable under more than one (1) of Sections 2, 3 or 4 above.

 

6.          If Licensee desires to license any Intellectual Property from any third parties for use in association with a Licensed Product or Inspired Product, then Licensee may reduce any royalty owed to Licensor under this Agreement in association with any Licensed Products or Inspired Products that incorporate such third parties' Intellectual Property to a total percentage that will be the greater of: a) X- [***] *Y, or b) [***] *X, where:

 

X = The percentage royalty based on Net Sales otherwise due to Licensor for Sale of a Licensed Product or Inspired Product as per this Agreement; and

 

Y = The aggregate percentage of royalty based on Net Sales to be paid to the third parties for Sale of a Licensed Product or Inspired Product that also includes the third parties' Intellectual Property.

 

*** CONFIDENTIAL TREATMENT REQUESTED

 

Execution Version

Exclusive License Agreement 

Page 12
 

 

Licensee will use reasonable efforts to negotiate licenses with third parties that require the least possible reduction of Licensor's royalties.

 

7.          Notwithstanding paragraph 6 of this Exhibit A above, in the event that the aggregate percentage of royalties to be paid by Licensee to Licensor and all other third parties with respect to the Sale of a Licensed Product or Inspired Product, taking into account any adjustments set forth above or in such third party agreements, exceeds [***] percent of Licensee's Net Sales of such Licensed Product or Inspired Product, Licensee shall have the further right to reduce the royalty otherwise payable to Licensor and such third parties, on a pro rata basis, such that the aggregate royalties do not exceed [***] percent of Licensee's Net Sales with respect to such Licensed Product or Inspired Product. Any reductions made in accordance with this paragraph 7 shall be made on a pro-rata basis based on the royalty payments that would have been owed if no adjustments had been made.

 

8.          All payments to Licensor will be made fifty (50%) percent to Mantero and fifty (50%)
percent to Asnaghi.

 

9.          " Net Sales " means the gross revenues actually received by Licensee from Sale less sales
and/or use (or similar) taxes actually paid, import and/or export duties actually paid. For purposes of clarity, "Net Sales" do not include revenues received for equipment sold separately by Licensee which does not qualify as a Licensed Product or Inspired Product by itself.

 

10.          " Sale " means to sell, transfer, lease or otherwise dispose.

 

*** CONFIDENTIAL TREATMENT REQUESTED

  

Execution Version

Exclusive License Agreement 

Page 13

 

 

  

EXHIBIT 10.20

 

SPONSORED RESEARCH AGREEMENT

 

This SPONSORED RESEARCH AGREEMENT (this " Agreement ") is entered into as of the last date below written (the " Effective Date "), by and between SARA MANTERO, Ph.D. (" Mantero "); MARIA ADELAIDE ASNAGHI (" Asnaghi "); HARVARD BIOSCIENCE, INC ., a Delaware corporation (the " Company "); and the DEPARTMENT OF BIOENGINEERING OF THE POLITECNICO DI MILANO (" PDM ").

 

Recitals:

 

A.           Mantero is a faculty member and Asnaghi is a PhD student at PDM.

 

B.           Mantero and Asnaghi are the inventors of certain processes and devices that allow for the migration of organic cells into tissue samples while being incubated under ideal conditions in a specialized bioreactor (the "Technology").

 

C.           The parties to this Agreement have executed as of even date as this Agreement an Exclusive License Agreement (the " ELA "), whereby Company has obtained the exclusive license rights to the Technology and improvements related to the Technology.

 

D.           PDM hereby expressly waives and renounces to all and any right relating to the authorship, paternity, ownership, intellectual property, use, economic and commercial interests or of whatever other nature, that it has or may have on the Technology and on improvements related to the Technology.

 

E.           Company desires that Mantero, Asnaghi and PDM continue to perform certain research work related to improving and expanding upon the Technology as described in this Agreement and Company is willing to sponsor such research in accordance with the terms of this Agreement.

 

F.           The parties have determined that it is in their mutual best interests to enter into this Agreement to describe their mutual rights and responsibilities and to provide for how new intellectual property resulting from the research described in this Agreement will be owned and licensed.

 

THEREFORE, for good and valuable consideration, the receipt and adequacy of which is hereby recognized by the parties, the parties agree as follows:

 

1.           Term . By providing the other party ninety (90) days prior written notice, either party may terminate this Agreement for any or no reason any time after one (1) year from the Effective Date.

 

Execution Version

Sponsored Research Agreement

  

1
 

 

2.           Agreement to Research . During the term of this Agreement, PDM will use its own facilities and its best efforts to conduct the research program described in Exhibit A (" Research Program ") under the principal direction of Mantero or her successor as mutually agreed upon between Company and PDM (the " Principal Researcher "). Mantero and Asnaghi agree not to accept sponsorship from any competitor of Company to perform research similar to the research to be performed in the Research Program, with the understanding that a government entity, a foundation or a charity will not be considered a competitor of Company. The parties acknowledge that the certain distributor agreement executed by and between SKE Srl and Company as of the date of this Agreement does not cause conflict with this Agreement.

 

3.           Consideration . As consideration the receipt and adequacy of which is hereby acknowledged by the parties, Company agrees to loan to PDM up to Thirty-Five Thousand and 00/100 ($35,000.00) United States Dollars worth of equipment (the " Equipment ") during the term of this Agreement to be used solely in association with the Research Program. Further, Company will provide engineering support to PDM to help realize novel bioreactor designs developed during the term of this Agreement as mutually agreed upon by the parties.

 

4.           Consultation . During the period of this Agreement, Company's representatives or agents will be provided with access to the Principal Researcher both personally, by E-mail, by telephone and other means to discuss the Research Program. Company's agents and representatives will be permitted to visit the laboratories involved in the conduct of the Research Program as may be reasonably requested by Company.

 

5.           Reports . The Principal Researcher will make a written report to Company at least once every month summarizing the work completed under the Research Program since the date of the last report. The Principal Researcher and Company will also meet once every three (3) months in person at PDM to discuss the work completed under the Research Program since the date of the last in person meeting. The Principal Researcher will also submit to Company a comprehensive final report detailing the efforts and results of the Research Program within sixty (60) days after the termination of the Research Program.

 

6.           Intellectual Property . With respect to any intellectual property resulting from the Research Program, the parties agree to the terms determining their relative intellectual property rights as described in Exhibit B .

 

7.           Publication and Other Academic Rights .

 

a.  To avoid the loss of patent rights as a result of premature disclosure of patentable information, Mantero, Asnaghi and PDM will submit any prepublication materials related to the Research Program to Company for review and comment at least thirty (30) days prior to the planned submission for publication, If Company determines that the proposed publication contains patentable subject matters that should be protected, Company may require the delay of the submission for a period of time not to exceed sixty (60) days after the date of the original planned submission date for publication for the purpose of allowing the pursuit of such protection.

 

b.  Mantero and Asnaghi may discuss the Research Program with other investigators and academics solely for scientific or research purposes but will not reveal information that is Confidential Information (as defined in the ELA) that belongs to Company. If any jointly owned intellectual property results from such discussions, then PDM, Mantero and Asnaghi will and hereby grant Company the rights set forth in Exhibit B if possible. In all cases, PDM will use its best efforts to obtain rights for Company in such joint intellectual property.

 

Execution Version

Sponsored Research Agreement

  

2
 

 

 

8.           Equipment Title . The Equipment will at all times during this Agreement be the sole and exclusive property of Company. PDM hereby acknowledges that Company is the owner of the Equipment and further acknowledges that PDM will acquire no ownership, title or other property rights in the Equipment by reason of this Agreement. Upon termination of this Agreement, PDM will return the Equipment to Company at an address to be specified by Company.

 

9.           Equipment Use . PDM will not use, maintain, or store the Equipment in violation of any applicable regulatory laws or regulations of any governmental agency.

 

10.          Equipment Repairs, Replacements and Modifications . PDM will, at its own expense, make all repairs and replacements to the Equipment during the continuance of this Agreement necessary to keep and maintain the Equipment in good mechanical condition and repair, including, but not limited to, all repairs occasioned by accident. All attachments, accessories and repairs at any time made to or placed upon the Equipment or any replacement thereof, will become part of the Equipment and will immediately become the property of Company for all purposes. All Equipment replacement parts and accessories, will immediately become the property of Company for all purposes,

 

11.          DISCLAIMER OF WARRANTIES AND WAIVER OF DEFENSES . COMPANY MAKES NO WARRANTY, EXPRESSED OR IMPLIED, TO ANYONE, AS TO THE FITNESS, MERCHANTABILITY, DESIGN, CONDITION, CAPACITY, PERFORMANCE, OR ANY OTHER ASPECT OF THE EQUIPMENT OR ITS MATERIAL OR WORKMANSHIP. COMPANY FURTHER DISCLAIMS ANY LIABILITY FOR LOSS, DAMAGE OR INJURY TO ANY PARTIES TO THIS AGREEMENT OR THIRD PARTIES AS A RESULT OF ANY DEFECTS, LATENT OR OTHERWISE, IN THE EQUIPMENT WHETHER ARISING FROM COMPANY'S NEGLIGENCE OR APPLICATION OF THE LAWS OF STRICT LIABILITY.

 

12.          Jurisdiction and Disputes; Choice of Law . The rights and obligations of the parties under this Agreement shall be governed by the laws of Italy. In the event of any dispute, controversy or claim arising out of or relating to this Agreement, or to the breach or termination hereof (a " Dispute "), the parties agree to resolve the same as follows:

 

(a)          The parties to the Dispute shall initially attempt to resolve it through consultations and negotiations.

 

Execution Version

Sponsored Research Agreement

 

 

3
 

 

 

(b)          If the Dispute has not been resolved amicably within thirty (30) days after any party provides notice thereof, unless the parties agree otherwise, the Dispute shall be resolved by a single arbitrator in a final and binding arbitration that will be conducted in Milan, Italy in accordance with the Arbitration Rules of the Chamber of Commerce of Milan, as in effect on the Effective Date (the "Milan Rules"). The International Centre for Dispute Resolution (" ICDR ") shall serve as the appointing authority. If the parties cannot agree on the arbitrator then an arbitrator experienced in matters similar to the Dispute will be chosen by ICDR. The language to be used in the arbitration proceeding shall be English, The arbitration shall be administered by the ICDR under the Milan Rules. The arbitrator shall render a written award stating the reasons for the decision. An arbitration award or decision may be entered by any court of competent jurisdiction, or application may be made to such a court for judicial acceptance of the award or decision and any appropriate order, including enforcement. All direct costs of an arbitration proceeding under this Section, including fees and expenses of arbitration, shall be borne equally by the parties hereto. All other costs, including counsel and witness fees, shall be borne by the party incurring them.

 

(c)          Each of the parties hereto consents to the submission of any Dispute for settlement by final and binding arbitration in accordance with paragraph (b) above, Such consent shall satisfy the requirements for an "agreement in writing" pursuant to Article II of the United Nations Convention on the Recognition and Enforcement of Foreign Arbitration Awards, done at New York on June 10, 1958.

 

(d)          Each of the parties hereby undertakes to carry out without delay the provisions of any arbitration award or decision.

 

13.          Integration . With respect to the subject matter of this Agreement, this Agreement constitutes the entire understanding between the parties and supersedes any prior discussions, negotiations, agreements and understandings.

 

14.          Notice . All notices and other communications required or permitted under this Agreement will be in writing and will be deemed given when delivered personally or by registered or certified mail, return receipt requested, addressed as follows (or any other address that is specified in writing by either party):

 

To Mantero:

 

Sara Mantero

Dipartimento di Bioingegneria

Politecnico di Milano

Via Golgi 39 (Ed.34 - piano IV)

20133 Milan
Italy

 

To Asnaghi:

 

Maria Adelaide Asnaghi
Via Piave 54
20036 Meda (MI)
Italy

 

Execution Version

Sponsored Research Agreement

 

4
 

 

To PDM:

 

Giancarlo Ferrigno
Dipartimento di Bioingegneria
Politecnico di Milano
Via Golgi 39 (Ec1.34 - piano IV)
20133 Milan
Italy

 

To Company:

 

Harvard Bioscience, Inc.
84 October Hill Road
Holliston, Massachusetts 01746
United States of America

 

With a copy to:

 

Jaffe, Raitt, Heuer & Weiss, P.C.
Attn: Sara M. Kruse, Esq.
27777 Franklin Rd., Suite 2500
Southfield, Michigan 48034
United States of America

 

15.          Severability . Whenever possible, each provision of this Agreement will be interpreted in such a way as to be effective and valid under applicable law. If a provision is prohibited by or invalid under applicable law, it will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

16.          Assignments . No assignment of this Agreement or of any right or obligation under this Agreement will be made by any party without the prior written consent of the other parties hereto, such consent not to be unreasonably withheld. Further, Company may assign its rights under the Agreement without the prior written consent of the other parties so long as Company remains responsible for any obligations in respect of this Agreement

 

17.          Waiver . Any party's failure to exercise a right or remedy will not operate as a waiver of any of such party's rights or remedies or the other parties' obligations under this Agreement and will not constitute a waiver of its right to declare an immediate or a subsequent default.

 

18.          Amendments . The terms of this Agreement may not be varied or modified in any manner, except in a subsequent writing executed by an authorized representative of each party.

 

19.          Independent Contractors . In their relationship under this Agreement, each party is an independent contractor. Nothing in this Agreement on its own will be construed such that either party will be considered an agent or partner of the other.

 

Execution Version

Sponsored Research Agreement

 

 

5
 

 

 

20.          Survival . The following Sections will survive the termination of this Agreement: 1, 6 - 9 and 11 - 25.

 

21.          Counterparts . This Agreement may be executed in one or more counterparts, each of which will be deemed an original agreement, but all of which will be considered one instrument and will become a binding agreement when one or more counterparts have been signed by each of the parties and delivered to the other. A facsimile of this document bearing a party's signature or a printed copy of the original, signed document scanned in .pdf or .tif format will have the same legal force and effect as an original of such signature and will be treated as an original document for evidentiary purposes.

 

22.          Force Majeure . No party will be deemed to be in default or otherwise responsible for delays or failures in performance resulting from acts of God, acts of war or civil disturbance, epidemics, governmental action or inaction, fires, earthquakes, unavailability of labor, materials, power or communication, or other causes beyond their reasonable control.

 

23.          No Third-Party Beneficiaries . This Agreement will not confer any rights or remedies upon any third-party, other than the parties to this Agreement and their respective successors and permitted assigns.

 

24.          Titles . Titles and headings to Sections in this Agreement are inserted for convenience of reference only and are not intended to affect the interpretation or construction of the Agreement.

 

25.          Ambiguity Not to Be Construed Against Drafter . Each party to this Agreement has been involved in its drafting and negotiation. No rule of law that ambiguity in an agreement will be construed against the drafter will be applied in interpreting this Agreement.

 

SIGNATURES ON NEXT PAGE

 

Execution Version

Sponsored Research Agreement

 

6
 

 

Agreed as of the date last below written:

 

Mantero:   Company:
       
    HARVARD BIOSCIENCE, INC.,
    a Delaware corporation
       
By: /s/ Sara Mantero      
         
SARA MANTERO, Ph.D.    
     
Dated:     By: /s/ David Green
         
Asnaghi:     Print Name: David Green
         
      Its: President
         
By: /s/ Maria Adelaide Asnaghi   Dated: 5 th August, 2009

 

MARIA ADELAIDE ASNAGHI      
       
Dated:        
         
PDM:        

 

DEPARTMENT OF BIOENGINEERING of the      
POLITECNICO DI MILANO      
       
By: /s/ Giancarlo Ferrigno      
         
Print Name: Prof GIANCARLO FERRIGNO, Ph.D      
         
Its:        
         
Dated:        

 

Execution Version

Sponsored Research Agreement

 

7
 

 

Exhibit A

 

Research Program

 

Mantero, Asnaghi and PDM will design and develop additional intellectual property relating to bioreactors, including other clinical applications, the scope of which will be determined by Mantero, Asnaghi, PDM and Company, from time-to-time.

 

Automation of the seeding process in both sides of the tubular structure.

 

Execution Version

Sponsored Research Agreement

 

8
 

 

Exhibit B

 

Intellectual Property Rights

 

1.          " New Technology " means any intellectual property developed through the Research Program that is not already included within the Licensed Technology (as defined in and set forth in the ELA).

 

2.          The parties acknowledge that Improvements (as defined in the ELA) developed through the Research Program are already included in the Licensed Technology and will be and already are licensed to Company pursuant to the terms of the ELA.

 

3.          The parties will consult regarding preparation and filing of any patent applications for Licensed Technology not currently protected by patent and for any New Technology, The party designated to file an application will provide the other parties, on a confidential basis, a copy of any such application filed and any documents received or filed during prosecution thereof with the opportunity to comment thereon. The parties will cooperate in obtaining execution of any necessary documents required to prosecute such patent applications or related filings. The party responsible for tiling the patent application may choose its own patent counsel and will be responsible for all costs associated with the filing and maintaining the patent if issued.

 

4.          Title to all intellectual property developed by Mantero, Asnaghi or other PDM employees resulting from the Research Program will reside with Mantero and Asnaghi. Title to all intellectual property developed by Company resulting from the Research Program will reside in Company. Title to all inventions and discoveries made jointly by Mantero, Asnaghi or other PDM employees and Company resulting from the research performed hereunder will reside jointly in Mantero and Asnaghi and Company.

 

5.          Mantero, Asnaghi and PDM grant to Company an option for a worldwide, royalty-bearing exclusive license for all intellectual property rights related to any New Technology and right to disclose and use the names of Mantero and Asnaghi in connection with promoting, advertising, marketing, licensing and/or selling the New Technology, as long as such disclosure and usage accurately describes their involvement in the development of the New Technology. Such option will be exercisable in the following manner: Whenever Company believes that it has identified a commercially exploitable New Technology, it will notify PDM of its desire to enter into such a license agreement, and the parties shall enter into an exclusive license agreement upon the same terms and conditions, including economic terms, as the ELA.

 

6.          Mantero, Asnaghi and PDM grant Company a fully paid-up, nonexclusive license under
their copyrights to make and distribute copies and to make derivative works from any written report or software source code prepared and delivered to Company in accordance with this Agreement.

 

Execution Version

Sponsored Research Agreement

 

9

 

   

EXHIBIT 10.21

 

   

NOVEL SURGERY AGREEMENT

 

  СОГЛАШЕНИЕ О ПРОВЕДЕНИИ РАНЕЕ НЕ ПРОВОДИВШЕЙСЯ ХИРУРГИЧЕСКОЙ ОПЕРАЦИИ
         
    This Novel Surgery Agreement (“Agreement”) is made, as of the last date set forth on the signature page below, between:   Настоящее Соглашение об проведении ранее не проводившейся хирургической операции («Соглашение») заключено на дату, указанную последней на странице с подписями, между:
         
    Harvard Apparatus Regenerative Technology, Inc. , a Delaware corporation having an office located at 84 October Hill Road, Holliston, Massachusetts 01746 Telephone: (508) 893-8999; Facsimile: (508) 892-6135 (“Manufacturer”),   Harvard Apparatus Regenerative Technology, Inc., корпорацией, зарегистрированной в штате Делавэр по адресу: 84 October Hill Road, Holliston, Massachusetts 01746, тел.: (508) 893-8999; факс: (508) 892-6135 («Изготовитель»),
         
    State Budget Institution of Public Health Department Regional Clinical Hospital #1 after Prof. S.V. Ochapovsky  located at 1st May 167, Krasnodar 350086 (“Hospital”), and   Государственное бюджетное учреждение здравоохранения «Краевая клиническая больница №1 имени профессора С.В. Очаповского расположенная по адресу: Краснодар 350086 ул. 1 мая, 167 («Больница»)), и
         
    [surgeon’s name], M.D., an employee of Hospital assigned to provide professional services at Hospital (“Principal Surgeon”).   [фамилия врача], врачом, сотрудником Больницы, назначенным для оказания профессиональных услуг в Больнице (далее – «Главный врач»).
         
   

WHEREAS, Principal Surgeon intends to employ a clinical protocol, entitled “Human Bioengineered Synthetic Tracheal Transplant Protocol”, as amended in writing from time to time and incorporated by reference herein (the “Clinical Protocol”), for the transplantation of the trachea, using a synthetic bioengineered scaffold seeded with autologous mononuclear cells (the “Surgery”), as an intraoperative solution for a patient (“Patient”);

 

  ПРИНИМАЯ ВО ВНИМАНИЕ, что Главный врач намерен использовать клинический протокол под названием «Протокол применения человеческого биоинженерного синтетического трансплантата трахеи», с вносимыми время от времени письменными изменениями, который включён в данное Соглашение путём ссылки («Клинический протокол»), для пересадки трахеи с использованием синтетического биоинженерного каркаса с всаженными аутогенными мононуклеарными клетками («Хирургическая операция») в качестве интраоперационного решения для пациента (далее – «Пациент»);
         
    WHEREAS, the Clinical Protocol contemplates the use of the In Breath® 3D Organ Bioreactor (the “Device”) in connection with the Surgery and Manufacturer owns the rights to and manufactures the Device;   ПРИНИМАЯ ВО ВНИМАНИЕ, что Клинический протокол включает применение устройства In Breath® 3D Organ Bioreactor («Устройство») в связи с Хирургической операцией, и Изготовитель владеет правами на Устройство и его изготовление;

  

 

 
 

 

    WHEREAS, Hospital has facilities and personnel with the requisite skills experience and knowledge to participate in the Surgery in accordance with the Clinical Protocol referenced above; and   ПРИНИМАЯ ВО ВНИМАНИЕ, что в Больнице имеются помещения и персонал, обладающий необходимыми навыками, опытом и знаниями для участия в Хирургической операции в соответствии с указанным выше Клиническим протоколом, а также,
         
    WHEREAS, the parties wish to collaborate on the Surgery in a manner beneficial to each of them.   ПРИНИМАЯ ВО ВНИМАНИЕ, что стороны выразили желание вести взаимовыгодное сотрудничество для проведения Хирургической операции,
         
    NOW, THEREFORE, in consideration of the premises and mutual promises and covenants expressed herein the parties agree as follows:   С УЧЁТОМ ВЫШЕИЗЛОЖЕННОГО, принимая во внимания исходные условия и взаимные обещания сторон, а также договорённости, изложенные в данном документе, стороны пришли к следующему соглашению:

 

1.   Surgery   Хирургическая операция
         
1.1.   Principal Surgeon will perform the Surgery at the Hospital (or at such other location agreed to by the parties) according to applicable Clinical Protocols, using his professional expertise and reasonable professional practices.   Главный врач проведёт Хирургическую операцию в Больнице (или в другом таком месте, согласованным сторонами) в соответствии с применимыми Клиническим протоколами, используя свой профессиональный опыт и разумную профессиональную практику.
         
1.2.   Hospital will provide qualified personnel, equipment, and materials (except as otherwise provided by Manufacturer), and facilities necessary to perform the Surgery in accordance with the Clinical Protocol and this Agreement. Hospital and Principal Surgeon shall at all times comply with all applicable laws and regulations relating to the use of such equipment and materials, and shall at all times comply with the requirements for obtaining prior, written informed consent of the Patient and/or Patient’s representatives (“Informed Consent”) in the form or similar acceptable form as set forth in Appendix 1.   Больница обеспечит квалифицированный персонал, оборудование и материалы (кроме тех которые иначе будут предоставлены Изготовителем), а также помещения, необходимые для проведения Хирургической операции в соответствии с Клиническим протоколом и данным Соглашением. Больница и Главный врач должны постоянно соблюдать требования всех применимых законов и постановлений, которые относятся к использованию такого оборудования и материалов, и должны во всё время выполнять требования получения предварительного, осведомлённого письменного согласия Пациента и/или представителей Пациента («Осведомлённое согласие») по форме или в похожей приемлемой форме в соответствии с Приложением №1.

 

 
 

 

2.   Principal Surgeon   Главный врач
         
2.1   The Surgery will be performed by and under the direction of Principal Surgeon.   Хирургическая операция будет произведена Главным врачом и под его руководством.
         
2.2   Hospital and Principal Surgeon represent and warrant that Principal Surgeon is not the subject of a proceeding by any Board of Medical Examiners or similar agency.   Больница и Главный врач заверяют и гарантируют, что Главный врач субъектом разбирательства со стороны Совета Медицинской Экспертизы (Board of Medical Examiners) или схожей инстанции.
         
3.   Institutional Approvals   Одобрения учреждениями
         
3.1   Hospital and Principal Surgeon shall not allow the Surgery nor any preparation for the Surgery until the Surgery has been unconditionally approved by any and all applicable authorities including all the terms and conditions of the Surgery, including without limitation the Informed Consent of the Patient, the Clinical Protocol and the participation of Hospital and Principal Surgeon in the Surgery.   Больница и Главный врач не должны разрешать, ни проведения Хирургической операции, ни какой-либо подготовки к Хирургической операции до тех пор, пока не будут получены безусловные одобрения проведения Хирургической операции от всех и любых соответствующих властей, включая все условия и положения Хирургической операции, включая без ограничений, Осведомлённое согласие Пациента, Клинический протокол и участие Больницы и Главного врача в проведении Хирургической операции.
         
4.   Supply of Surgery Materials   Поставка материалов для Хирургической операции
         
4.1   Manufacturer will provide the Device, and Principal Surgeon and Hospital shall provide all other devices, services, equipment and other supplies necessary for conduct of the Surgery. Neither Principal Surgeon nor Hospital may provide or demonstrate the Device to any other persons or entities not described in this Agreement without the prior express written consent of Manufacturer.   Изготовитель предоставит Устройство, а Главный врач и Больница должны предоставить все остальные приспособления, услуги, оборудование и прочие материалы, необходимые для проведения Хирургической операции. Ни Главный врач, ни Больница не могут предоставить или демонстрировать Устройство каким-либо прочим лицам или субъектам, не указанным в данном Соглашении, без предварительного, прямо выраженного письменного согласия Изготовителя.
         
5.   Access to Facilities and Personnel   Доступ к помещениям и персоналу
         
5.1   Hospital will allow Manufacturer (or its designees) reasonable access during business hours and at mutually convenient times to the Hospital (or such other location as the Surgery or any post-operative activities take place) and Principal Surgeon for the purpose of assisting Principal Surgeon and his team in use of the Device, monitoring the Surgery in accordance with the Clinical Protocol and/or the Informed Consent, reviewing documents and other matters related to the Surgery.   Больница разрешит Изготовителю (или указанным им лицам) доступ в Больницу в разумных пределах, в рабочее время и в часы, обоюдно выгодные как для Больницы (или подобного другого места, когда будет проводиться Хирургическая операция или любые после-операционные процедуры), так и для Главного врача, с целью помочь Главному врачу и его группе в использовании Устройства, ведении мониторинга Хирургической операции в соответствии с Клиническим протоколом и/или Осведомлённым согласием, для проверки документов и прочих вопросов, связанных с Хирургической операцией

 

 
 

 

6.   Access to Surgery Reports and Results   Доступ к отчетам и результатам Хирургической операции
         
6.1   Hospital and Principal Surgeon agree to disclose and make available to Manufacturer (or its designee) all pre- and post-operative records, follow-up reports and other records concerning the Surgery prepared by Hospital or Principal Surgeon, either alone or with others, in each case consistent with the scope of the Informed Consent and the confidentiality waiver authorization given by the Patient, for the purpose of Manufacturer’s use of such information to improve the Device or invent other devices for use in future procedures   Больница и Главный врач соглашаются раскрыть информацию и предоставить Изготовителю (или назначенным им лицам) доступ ко всем до- и после-операционным записям, последующим отчётам и прочим документам, связанным с Хирургической операцией, которые были подготовлены Больницей или Главным врачом, по отдельности или с другими лицами, в каждом отдельном случае в рамках Осведомлённого согласия и отказа от конфиденциальности данных Пациентом, в целях использования такой информации Изготовителем для усовершенствования данного Устройства или изобретения других устройств для использования в будущих процедурах.
         
7.   Inventions; Ownership of Intellectual Property   Изобретения; права на интеллектуальную собственность
         
7.1   It is recognized and understood that the existing inventions and technologies, including, but not limited to the Confidential Information of Manufacturer or Hospital are their separate property, respectively, and are not affected by this Agreement. Hospital shall not have any claims to or rights in such existing inventions and technologies of Manufacturer (including, without limitation, Manufacturer’s Confidential Information), and Manufacturer shall not have any claims to or rights in such existing inventions and technologies of Hospital (including, without limitation, Hospital’s Confidential Information). For purposes hereof, “Confidential Information” shall mean any and all information, materials and data that is disclosed by one party to the other pursuant to this Agreement and designated as “confidential” at the time of initial disclosure if disclosed in writing or, if initially disclosed orally, identified by the disclosing party as confidential at the time of disclosure and thereafter summarized in writing and designated as “confidential” within 30 days after the initial oral disclosure. Confidential Information shall not include any information, materials or data which: (i) at the time of disclosure hereunder is generally available to the public; (ii) after disclosure hereunder becomes generally available to the public, except through breach of this Agreement by the recipient; (iii) the recipient can demonstrate was in its possession prior to the time of disclosure by the disclosing party hereunder, and was not acquired directly or indirectly from the disclosing party under an obligation of confidentiality; (iv) becomes available to the recipient from a third party which is not legally prohibited from disclosing such Confidential Information, provided such Confidential Information was not acquired directly or indirectly from the disclosing party under an obligation of confidentiality; or (v) the recipient can demonstrate was developed by or for the recipient independently of the disclosure of Confidential Information by the disclosing party.   Признаётся и понимается, что существующие изобретения и технологии, включая, но не ограничиваясь Конфиденциальной информацией Изготовителя или Больницы соответственно, являются отдельными объектами собственности, и не попадают под действие данного Соглашения. Больница не должна предъявляет каких либо претензий или заявлять о правах на такие существующие изобретения и технологии Изготовителя (включая, без ограничений, Конфиденциальную информацию Изготовителя), и Изготовитель не должен предъявлять никаких претензий или заявлять о правах на такие существующие изобретения и технологии Больницы (включая, без ограничений, Конфиденциальную информацию Больницы). В рамках данного соглашения, «Конфиденциальная информация» означает всю без исключения информацию, материалы и данные, которые передаются одной стороной другой стороне согласно данному Соглашению и которые обозначены как «конфиденциальные» в момент их первоначального раскрытия, если они были раскрыты в письменной форме, или если они были первоначально раскрыты в устной форме, обозначены передающей стороной как конфиденциальные в момент раскрытия и впоследствии обобщены в письменной форме и указаны как «конфиденциальные» в течение 30 дней после первоначального устного раскрытия информации. Конфиденциальная информация не должна включать в себя никакой информации, материалов или данных, которые: (i) в момент раскрытия по данному Соглашению являются общедоступными; (ii) после раскрытия по данному Соглашению, они становятся общедоступными, за исключением случаев, когда это произошло в результате нарушения Соглашения получателем; (iii) получатель может доказать, что он владел этой информацией до её раскрытия передающей стороной согласно данному Соглашению, и она не была получена прямо или косвенно от передающей стороны в соответствии с обязательствами о конфиденциальности; (iv) могли попасть к получателю от третьей стороны, в отношении которой нет юридических оснований запрещающих раскрытие такой Конфиденциальной информации, при условии, что такая Конфиденциальная информация не была получена прямо или косвенно от передающей стороны в соответствии с обязательствами о конфиденциальности; или (v) получатель может продемонстрировать, что она была разработана получателем или для него, независимо от раскрытия Конфиденциальной информации передающей стороной.

 

 
 

 

7.2   All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement shall belong solely to Manufacturer if conceived, discovered or invented solely by Manufacturer or an employee or consultant of Manufacturer. All right, title and interest to any invention, whether or not patentable, which arises from Manufacturer’s Confidential Information or the Device shall also be owned solely by Manufacturer (both referred to as a “Manufacturer Invention”).   Все права, собственность и интерес в каком-либо изобретении, патентоспособном ли или нет, полученные в результате выполнения данного Соглашения, должны принадлежать исключительно Изготовителю, если изобретение было задумано, открыто или изобретено исключительно Изготовителем или сотрудником или консультантом Изготовителя. Всеми правами, собственностью и интересом в каком-либо изобретении, патентоспособном или нет, возникающими из Конфиденциальной информации или Устройства Изготовителя, также владеет исключительно Изготовитель (в обоих случаях они называются «Изобретение Изготовителя»).
         
7.3   All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement shall belong solely to Hospital if conceived, discovered or invented solely by Hospital or an employee or consultant of Hospital, without any access to Manufacturer’s Confidential Information or use of Manufacturer’s technology, resources or other property (including, without limitation, the Device) (a “Hospital Invention”).   Все права, собственность и интерес в каком-либо изобретении, патентоспособном ли или нет, возникающие в связи с выполнением данного Соглашения, принадлежат исключительно Больнице, если изобретение было задумано, открыто или изобретено исключительно Больницей или сотрудником или консультантом Больницы, без какого-либо доступа к Конфиденциальной информации Изготовителя или использования технологии, ресурсов или иной собственности Изготовителя (включая, помимо прочего, Устройство) («Изобретение Больницы»)
         
7.4   All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement and which is conceived, discovered or invented jointly by Manufacturer or an employee or consultant of Manufacturer and Hospital or an employee or consultant of Hospital shall be owned jointly by Manufacturer and Hospital (a “Joint Invention”).   Всеми правами, собственностью и интересами в каком-либо изобретении, патентоспособном ли или нет, возникающие в связи с выполнением данного Соглашения, если изобретение задумано, открыто или изобретено совместно Изготовителем или сотрудником или консультантом Изготовителя и Больницей или сотрудником или консультантом Больницы, совместно владеют Изготовитель и Больница («Совместное изобретение»)
         
7.5   Hospital hereby grants to Manufacturer an option to obtain a perpetual, worldwide license, to make, have made, use and sell products incorporating Hospital Inventions at a reasonable royalty rate and upon other reasonable terms, including exclusivity, to be negotiated by the parties. Manufacturer’s election to exercise its option must be in writing to Hospital. If, within ninety (90) days from the date Manufacturer is notified of a Hospital Invention, Hospital and Manufacturer do not execute a mutually agreeable license for such, Hospital may thereafter enter into a license with any third party with respect thereto.   Настоящим Больница предоставляет Изготовителю опцион на получение бессрочной лицензии действительной по всему миру, на изготовление, заказ на изготовление, использование и продажу продукции, содержащей Изобретения Больницы с уплатой роялти по разумной ставке и при выполнении других разумных условий, в том числе эксклюзивности, которые подлежат обсуждению сторонами. Решение Изготовителем о реализации данного опциона должно быть составлено в письменной форме и направлено Больнице. Если в течение девяноста (90) дней с даты уведомления, направленного Изготовителю в отношении Изобретения Больницы, Больница и Изготовитель не составят соглашение для получения взаимо согласованной лицензии, Больница может впоследствии в этих целях заключить соглашение о получении лицензии с любым третьим лицом.

 

 
 

 

7.6   Hospital shall have a royalty-free, non-exclusive licence to use any Manufacturer Inventions and/or Joint Inventions, solely for its internal educational and non-commercial research purposes and for the purpose of compliance with any applicable laws and regulations. With respect to all other uses, Manufacturer hereby grants to Hospital an option to obtain a perpetual, worldwide license, to Manufacturer Inventions at a reasonable royalty rate and upon other reasonable terms, including exclusivity, to be negotiated by the parties. Hospital’s election to exercise its option must be in writing to Manufacturer. If, within ninety (90) days from the date Hospital is notified of a Manufacturer Invention, Hospital and Manufacturer do not execute a mutually agreeable license for such, Manufacturer may thereafter enter into a license with any third party with respect thereto.   Больница должна иметь не эксклюзивную лицензию без уплаты роялти для использования любых Изобретений Изготовителя и/или Совместных Изобретений исключительно для своих внутренних образовательных и некоммерческих исследовательских целей, а также в целях выполнения требований любых применимых законов и нормативных актов. В отношении всех других видов применения, настоящим Изготовитель даёт Больнице опцион на получение бессрочной лицензии действующей по всему миру на Изобретения Изготовителя с уплатой роялти по разумной ставке и при выполнении других разумных условий, в том числе эксклюзивности, которые подлежат обсуждению сторонами. Решение Больницы о реализации данного опциона должно быть составлено в письменной форме и направлено Изготовителю. Если в течение девяноста (90) дней с даты уведомления, направленного Больнице в отношении Изобретения Изготовителя, Больница и Изготовитель не составят соглашение для получения взаимо согласованной лицензии, Изготовитель может впоследствии в этих целях заключить соглашение о получении лицензии с любым третьим лицом.
         
7.7   Each party shall have the unrestricted right to exploit any Joint Inventions.   Каждая из сторон имеет неограниченное право на использование любых Совместных Изобретений.
         
8.   Documentation Provided by Hospital   Документация, предоставляемая Больницей
         
8.1  

Hospital will submit the following documents to Manufacturer before commencing the Surgery:

 

(a)   a signed copy of any and all required approvals of the Surgery and Patient Informed Consent form, as required and approved by the appropriate authorities; and

 

(b)   a signed copy of the Clinical Protocol.

 

Больница представит Изготовителю следующие документы до начала Хирургической операции:

 

a)   подписанные копии всех и любых одобрений требуемых для проведения Хирургической операции и Осведомлённое согласие Пациента, как того требуют и одобряют соответствующие власти; и

 

b)   подписанную копию Клинического протокола

 

 
 

 

9.   Privacy   Конфиденциальность
         
9.1   Manufacturer hereby agrees to fully comply with all applicable laws relating to privacy of Patient health information and the regulations adopted pursuant thereto. Without any limitation to the foregoing, the parties understand that in connection with the Agreement, certain Patient data must be exchanged between Hospital and Manufacturer. Manufacturer agrees to fully comply with appropriate confidentiality requirements and regulations, and specifically agrees to:   Изготовитель выражает согласие полностью выполнять требования всех применимых законов, связанных с конфиденциальностью медицинской информации Пациента, и нормативными актами, принятыми в целях обеспечения оной. Без каких-либо ограничений на счёт вышеуказанного, стороны понимают, что в связи с данным Соглашением, определённые данные о Пациенте должны обмениваться между Больницей и Изготовителем. Изготовитель согласен полностью выполнять соответствующие требования по конфиденциальности, и в особенности соглашается:
         
   

(a)    not use or further disclose Patient health information and/or electronic protected health information other than as permitted or required by the Agreement or as required by law;

 

(b)    use appropriate safeguards to prevent use or disclosure of information other than as required for by the Agreement;

 

(c)    report to the Hospital any use or disclosure of the information not provided for by the Agreement of which it becomes aware,

 

(d)    ensure that any agents, including a subcontractor, to whom Manufacturer provides protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital, agree to the Manufacturer’s restrictions and conditions that apply to Manufacturer as a business partner of Hospital with respect to such information;

 

(e)    make available protected health information and/or electronic protected health information for amendment and incorporate any amendments to protected health information and/or electronic protected health information as required by law;

 

(f)    make its internal practices, books and records related to the use and disclosure of protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital available to the U.S. Secretary of Health and Human Services if so required;

 

(g)   return or destroy, at termination of this Agreement, if feasible, all protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital that Manufacturer still maintains in any form and retain no copies of such information; or, if such return or destruction is not feasible, extend the protection of the Agreement to the information and limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible.

 

a)   не использовать или в дальнейшем не раскрывать медицинскую информацию Пациента и/или медицинскую информацию защищённую средствами электронной защиты, кроме случаев, когда это разрешается или требуется Соглашением или требуется по закону;

 

b)   использовать соответствующие защитные меры для предотвращения использования или раскрытия информации, кроме того как это требуется Соглашением;

 

c)   сообщить Больнице, о любых случаях использования или раскрытия информации, которые не предусмотрены Соглашением о которых ему становится известно;

 

d)   обеспечить, чтобы любые посредники, включая подрядчиков, которым Изготовитель предоставляет защищённую медицинскую информацию и/или медицинскую информацию защищённую средствами электронной защиты, полученную или созданную, или полученную Изготовителем от имени Больницы, были согласны с ограничениями и условиями Изготовителя, которые применяются к Изготовителю в качестве делового партнёра Больницы в отношении такой информации;

 

e)   предоставлять доступ к защищённой медицинской информации и/или медицинской информации защищённой средствами электронной защиты для внесения поправок и включать любые поправки в защищенную медицинскую информацию и/или медицинскую информацию защищённую средствами электронной защиты в соответствии с требованиями законодательства;

 

f)   если необходимо, предоставлять доступ к информации о своей внутренней практике, журналам и записям, связанным с использованием и раскрытием защищённой медицинской информации и/или медицинской информации защищённой средствами электронной защиты, полученной от или созданной, или полученной Изготовителем по поручению Больницы, министру здравоохранения и социального обеспечения США;

 

g)   по прекращении действия данного Соглашения вернуть или уничтожить, если это осуществимо, всю защищённую медицинскую информацию и/или медицинскую информацию защищённую средствами электронной защиты, полученную от или созданную, или полученную Изготовителем по поручению Больницы, которую Изготовитель продолжает содержать в какой-либо форме, и не сохранять никаких копий такой информации; или, если такой возврат или уничтожение неосуществимо, продлить срок защиты информации данным Соглашением и ограничить её последующее использование и раскрытие такими целями, которые делают возврат или уничтожение информации невозможными.

 

 
 

 

9.2   A violation of this section shall be a material violation of this Agreement and cause for termination notwithstanding any provision in the Agreement to the contrary.   Нарушение условий данного раздела рассматривается как существенное нарушение данного Соглашения и является основанием для расторжения, невзирая на какие либо положения Соглашения об обратном.
         
9.3   Manufacturer also agrees that if it becomes necessary to amend this Agreement to fulfill the purposes of any applicable laws or regulations that Manufacturer agrees to do so without additional consideration.   Изготовитель также соглашается, что если возникнет необходимость внесения поправок в данное Соглашение для выполнения требований применимых законов или нормативных актов, Изготовитель соглашается на это без дополнительного рассмотрения вопроса.

 

 
 

 

10.   Device Offered for Single Use Not for Sale or Public Use   Устройство предлагается для одноразового использования и не подлежит продаже или общему пользованию
         
10.1   Without limiting the generality of any other confidentiality provisions under this Agreement, Hospital and Principal Surgeon acknowledge that the Device is investigational and agree (a) to use the Device solely in connection with the Surgery and not to use the Device again including, without limitation, in connection with any other procedure, and (b) not to offer the Device for commercial sale or use.   Без ограничений общего характера любых прочих условий по конфиденциальности, содержащихся в настоящем Соглашении, Больница и Главный врач признают, что Устройство является исследовательским и соглашаются, (a) использовать Устройство исключительно в целях проведения Хирургической операции и не использовать Устройство повторно, включая, без каких либо ограничений, для произведению любых других процедур, и (b) не предлагать Устройство для коммерческой продажи или использования.
         
11.   Insurance   Страхование
         
11.1   Hospital shall maintain, during the course of this Agreement and for a period of at least two (2) years thereafter, its program of self insurance against such risks in minimum amounts of 1,000,000.00 Rubles per occurrence and or in such other higher amounts as may be required by applicable laws and/or regulations. Upon request, Hospital shall provide certification of such insurance coverage to Manufacturer.   В течение срока действия настоящего Соглашения и в течение периода продолжительностью не менее 2 (двух) лет после завершения срока его действия, Больница обязана сохранять в силе свою программу само страхования от подобных рисков в размере минимум 1,000,000 рублей за каждый страховой случай и/или прочих более крупных сумм в зависимости от требований применимого законодательства и/или нормативных актов. По требованию Изготовителя Больница обязана предоставить документальные подтверждения такого страхового покрытия.
         
11.2   Manufacturer shall maintain, during the course of this Agreement and for a period of at least two (2) years thereafter, liability insurance in the amount of Two Million Dollars ($2,000,000) per occurrence and Four Million Dollars ($4,000,000) annual aggregate with financially sound and reputable insurance companies. Upon request, Manufacturer shall provide certification of such insurance coverage to Hospital.   В течение срока действия настоящего Соглашения и в течение периода длительностью не менее 2 (двух) лет после завершения срока его действия, Изготовитель обязан обеспечить страхование ответственности в размере 2 000 000 (двух миллионов) долларов США за каждый страховой случай и общей годовой суммы страховых выплат в 4 000 000 (четыре миллиона) долларов США у финансово стабильных и авторитетных страховых компаний. По требованию Изготовителя Больница обязана предоставить документальные подтверждения такого страхового покрытия.

 

 
 

 

12.   Indemnification and Responsibility   Возмещение ущерба и ответственность
         
12.1   By Manufacturer:   Со стороны Изготовителя:
         
   

(a)    Manufacturer hereby agrees to indemnify, defend and hold harmless Hospital and its directors, trustees, officers, shareholders, agents, and employees, including, but not limited to Principal Surgeon and assistants in the Surgery (hereafter collectively referred to as “Hospital Indemnitees”) from and against any and all claims, liabilities, losses, judgments, obligations, damages, costs and expenses (including reasonable attorneys’ fees) (collectively “Claims”) arising out of claims made or brought on behalf of Patient (or his representatives or dependents) for personal injury (including death) that arises from or is attributable to the design, production, manufacture of the Device.

 

(b)    The indemnification obligation set forth in this Section 12.1 shall not apply in the event and to the extent that such Claims arose as a result of (i) the wilful misconduct or negligence by Hospital Indemnitees or (ii) the “sole negligence” of one or any of the Hospital Indemnitees;

 

(c)    Hospital Indemnitees shall provide Manufacturer written notice of a Claim no later than fourteen (14) days after the Hospital Indemnitees have notice of such Claim for which indemnification is sought;

 

(d)    Manufacturer shall have sole control over the defense and settlement of a Claim for which indemnification is sought, and Hospital Indemnitees shall cooperate with the Manufacturer and its legal representatives in the investigation and defense of the Claim;

 

(e)    Manufacturer shall act reasonably and in good faith with respect to the defense or settlement of the Claim and will not reach any settlement which requires an admission of fault by a Hospital Indemnitee without that Hospital Indemnitee’s consent;

 

(f)    Hospital Indemnitees may, at their own expense, obtain separate legal counsel.

 

 

 

(a)   Настоящим Изготовитель соглашается индемнифицировать, защищать и ограждать Больницу и её директоров, попечителей, должностных лиц, акционеров, посредников и сотрудников, включая, но не ограничиваясь, Главного врача и ассистентов в Хирургическом отделении (в дальнейшем вместе именуемым "Индемнифицируемые лица") от и против любых и всех претензий, ответственности, убытков, судебных постановлений, обязательств, возмещения убытков, издержек и расходов (в том числе разумных гонораров адвокатов) (вместе "Претензий"), проистекающий из претензий, заявленных или поданных от имени Пациента (или его представителей или иждивенцев) в связи с причинением вреда здоровью (в том числе смертью), произошедшим от или могущими быть обусловленными проектированием, производством, изготовлением Устройства;

 

(b)   Обязательство по индемнификации, предусмотренное в настоящем пункте 12.1, не должны применяться в случае возникновения и в степени таких Претензий, если те возникли в результате (i) умышленного нарушения или халатности со стороны Индемнифицируемых лиц Больницы или (ii) "единоличной халатности" одного или любого из Индемнифицируемых лиц Больницы;

 

(c)   Индемнифицируемые лица Больницы должны направить Изготовителю письменное уведомление о Претензии не позднее 14 (четырнадцати) дней после получения Индемнифицируемыми лицами Больницы уведомления о такой Претензии, по которой подаётся требование о индемнификации;

 

(d)   Изготовитель должен имеет единоличный контроль в отношении защиты и урегулирования Претензии, по которой подаётся требование о индемнификации, а Индемнифицируемые лица Больницы должны содействовать Изготовителю и его юридическим представителям в расследовании и защите по Претензии;

 

(e)   Изготовитель обязан действовать разумно и добросовестно в отношении защиты или урегулирования Претензии и не будет добиваться какого либо урегулирования, которое потребует признания нарушения со стороны Индемнифицируемого лица Больницы без согласия такого Индемнифицируемого лица Больницы;

 

(f)   Индемнифицируемые лица Больницы могут за свой собственный счёт обратиться за отдельной юридической консультацией.

 

 
 

 

12.2   By Hospital and Principal Surgeon:   Со стороны Больницы и Главного врача:
         
   

(a)    Hospital and Principal Surgeon hereby agree to indemnify, defend and hold harmless Manufacturer and its directors, officers, shareholders, agents, and employees (hereafter collectively referred to as “Manufacturer Indemnitees”) from and against any and all Claims arising out of claims made or brought on behalf of Patient (or his dependents) for personal injury (including death) that arises from or is attributable to the services provided by Hospital and Principal Surgeon in connection with the Surgery.

 

(b)    The indemnification obligation set forth in this Section 12.2 shall not apply in the event and to the extent that such Claims arose as a result of (i) the wilful misconduct or negligence by Manufacturer Indemnitees; (ii) the “sole negligence” of one or any of the Manufacturer Indemnitees; or (iii) the design, production or manufacture of the Device by any of the Manufacturer Indemnitees.

 

(c)    Manufacturer Indemnitees shall provide the Hospital written notice of a Claim no later than fourteen (14) days after the Manufacturer Indemnitees have notice of such Claim for which indemnification is sought.

 

(d)    Hospital and Principal Surgeon shall have sole control of the defense and settlement of a Claim for which indemnification is sought, and Manufacturer Indemnitees shall cooperate with the Hospital, Principal Surgeon and their legal representatives in the investigation and defense of the Claim.

 

(e)    Hospital and Principal Surgeon shall act reasonably and in good faith with respect to the defense or settlement of the Claim and will not reach any settlement which requires an admission of fault by a Manufacturer Indemnitee without that Manufacturer Indemnitee’s consent.

 

(f)    Manufacturer Indemnitees may, at their own expense, obtain separate legal counsel.

 

(a)   Настоящим Больница и Главный врач соглашаются индемнифицировать, защищать и ограждать Изготовителя и его директоров, должностных лиц, акционеров, посредников и сотрудников, (в дальнейшем именуемым в совокупности "Индемнифицируемые лица Изготовителя") от и против любых и всех претензий, заявленных или поданных от имени Пациента (или его иждивенцев) в связи с причинением вреда здоровью (в том числе смертью), произошедшим от или могущими быть обусловленными услугами, оказанными Больницей и Главным врачом в связи с Хирургической операцией.

 

(b)   Обязательство по возмещению ущерба, изложенные в настоящем пункте 12.2, не должны применяться в случае возникновения и в степени таких Претензий, если те возникли в результате (i) умышленного нарушения или халатности со стороны Индемнифицируемых лиц Изготовителя или (ii) "единоличной халатности" одного или любого из Индемнифицируемых лиц Изготовителя; или (iii) проектирования, производства или изготовления Устройства любым из Индемнифицируемых лиц Изготовителя.

 

(c)   Индемнифицируемые лица Изготовителя должны направить Больнице письменное уведомление о Претензии не позднее 14 (четырнадцати) дней после получения Индемнифицируемыми лицами Изготовителя уведомления о такой Претензии, по которой подаётся требование о индемнификации.

 

(d)   Больница и Главный врач должны имеет единоличный контроль в отношении защиты и урегулирования Претензии, по которой подаётся требование о индемнификации, а Индемнифицируемые лица Изготовителя обязаны содействовать Больнице, Главному врачу и их юридическим представителям в расследовании и защите по Претензии.

 

(e)   Больница и Главный врач обязаны действовать разумно и добросовестно в отношении защиты или урегулирования Претензии и не не будет добиваться какого либо урегулирования, которое потребует признания нарушения со стороны Индемнифицируемого лица Изготовителя без согласия такого Индемнифицируемого лица Изготовителя.

 

(f)   Индемнифицируемые лица Изготовителя могут за свой собственный счёт обратиться за отдельной юридической консультацией.

         
    The obligations of the parties under this Section 12 shall survive the termination of the Agreement.   Обязательства сторон, предусмотренные в настоящем разделе 12, не должны прекращаться после прекращения действия Соглашения.

 

 
 

 

13.   Fees   Гонорары
         
13.1   Manufacturer waives its fees for the use of the Device and Manufacturer’s involvement in the Surgery.   Изготовитель отказывается от своих гонораров за использование Устройства и участие Изготовителя в Хирургической операции.
         
14.   Notices   Уведомления
         
14.1   All notices or consents required or permitted by this Agreement shall be in writing in the English language, and shall be deemed given when delivered in person or deposited in first class registered or certified mail, return receipt requested, postage prepaid, or by recognized international, commercial, overnight courier, or given by facsimile with a confirmation copy, by regular mail addressed to such party at the address set forth below, unless such address is changed from time to time by written notice hereunder:   Все уведомления или согласия, требуемые или разрешённые настоящим Соглашением, должны подаваться в письменном виде на английском языке и считаются поданными при их личной доставке или отправке заказным почтовым отправлением первого класса или почтовым отправлением с объявленной ценностью с уведомлением о получении, оплаченным почтовым сбором, либо признанной международной коммерческой курьерской службой, обеспечивающей доставку в течение одного дня, либо при их отправке по факсу с подтверждением получения, либо обычной почтой на нижеуказанный адрес соответствующей стороны, если такой адрес не будет изменён время от времени путём подачи письменного уведомления, как предусмотрено в настоящем Соглашении:
         
14.2  

If to Manufacturer:

Thomas W. McNaughton, Chief Financial Officer

 

Harvard Apparatus Regenerative Technology, Inc.

 

84 October Hill Road

 

Holliston, MA 01746

 

Tel: 1+ (508) 893-8999

 

Fax: 1+ (508) 892-6135

 

Изготовителю:

 

Томасу У. МакНотону, директору по финансам (Thomas W. McNaughton, Chief Financial Officer)

 

Harvard Apparatus Regenerative Technology, Inc.

 

84 October Hill Road

 

Holliston, MA 01746

 

Тел.: 1+ (508) 893-8999

 

Факс: 1+ (508) 892-6135

 

   

If to Hospital:

 

State Budget Institution of Public Health Department  Regional Clinical Hospital # 1 after Prof. S.V. Ochapovsky 

 

1st May Street 167,

 

Krasnodar 350086

 

Tel: (861) 252 85 91, 252 73 02

 

Fax: (861) 252 82 17, 215 35 12

 

If to Principal Surgeon:

[——————]

 

В Больницу:

 

Государственное бюджетное учреждение общественного здравоохранения "Региональная клиническая больница № 1 имени проф. С.В. Очаповского

 

Ул. 1 мая, 167,

 

Краснодар 350086

 

Тел.: (861) 252 85 91, 252 73 02

 

Факс: (861) 252 82 17, 215 35 12

 

Главному врачу:

[——————]

 

 
 

 

15.   Legal proceeding reimbursement   Возмещение затрат на судебно-процессуальные действия
         
15.1   In the event that Hospital is requested or authorized by Manufacturer or required by government regulation, subpoena, or other legal process to produce documents or any Hospital personnel in any legal proceeding with respect to the Surgery, or Manufacturer’s use of the results of the Surgery, or pursuant to this Agreement, Manufacturer will, so long as Hospital is not a party to the proceeding in which the information is sought, reimburse Hospital for its time and expense, as well as the fees and expenses of its counsel incurred in responding to such a request.   В случае, если Изготовитель запрашивает или уполномочивает Больницу, либо если от нее по государственным нормативным актам, повесткам о вызове в суд или иначе в судебном порядке требуется предоставление документов или любых из сотрудников Больницы для участия в любых судебно-процессуальных действиях в отношении Хирургической операции, использования Изготовителем результатов Хирургической операции либо согласно настоящему Соглашению, Изготовитель, при условии, что Больница не является одной из сторон судебного процесса, для которого требуется информация, должен компенсировать Больнице потраченное время и расходы, а также гонорары и расходы её юридических советников, понесённые в ходе предоставления ответа на такой запрос.
         
16.   Miscellaneous   Прочие положения
         
16.1  

This Agreement will be governed by and construed in accordance with the following:

 

(a)  as to any matter or matters which relate to the performance of the Surgery and/or the medical care or treatment of the Patient, the laws of the Russian Federation;

 

(b)  as to any matter or matters which relate to the existence, validity, entitlement to use or the ownership of any intellectual property (including but without limitation the Device, the Clinical Protocol, Confidential Information, the Manufacturer Invention, the Hospital Invention and any Joint Invention), the federal laws of the USA and the laws of the Commonwealth of Massachusetts (and as between them without regard to conflicts of laws principles); and

 

(c)  as to all other matters relating to or otherwise connected with this Agreement including its existence and validity, the laws of the Russian Federation

 

without regard to conflicts of laws principles and so that where any matter contains a number of elements which do not all fall within one only of (a), (b) or (c) above such separate elements will be governed by the different laws as set out in (a), (b) or (c) notwithstanding that they together form part of the same matter.

 

 

 

Настоящее Соглашение регулируется и толкуется в соответствии с:

 

(a)    законами Российской Федерации по любому вопросу или вопросам, относящихся к выполнению Хирургической операции и/или медицинской помощи или лечению пациента;

 

(b)    федеральными законами США и законами штата Массачусетс (а также в отношениях между ними без учёта принципов коллизионного права) по любому вопросу или вопросам, относящимся к наличию, действительности, прав на использование или на владение в отношении интеллектуальной собственности (включая, но без ограничений в отношении Устройства, Клинического протокола, Конфиденциальной Информации, Изобретения Изготовителя, Изобретения Больницы и любого Совместного изобретения); и

 

(c)    законами Российской Федерации по прочим вопросам, связанным или иным образом относящимся к данному Соглашению, в том числе по его наличию и действительности

 

без учёта принципов коллизионного права и по любому вопросу, содержащему ряд элементов, не все из которых попадают только в один из вышеуказанных подпунктов (а), (b) или (с) выше, такие отдельные элементы будут регулироваться различными законами, указанными в подпунктах (а), (b) или (с), несмотря на то, что они вместе являются частью одного и того же вопроса.

 

 
 

 

16.2  

Each party hereto unconditionally and irrevocably:

 

(a)  agrees that the execution, delivery and performance by it of this Agreement and all other agreements, contracts, documents and writings relating to this Agreement constitute private and commercial acts and not public or governmental acts;

 

(b)  agrees that should any proceedings be brought against it or its assets, other than the assets protected by the diplomatic and consular privileges under the US Foreign Sovereign Immunities Act or any analogous legislation (“Exempted Assets”) in any jurisdiction, in relation to this Agreement or any transaction contemplated by this Agreement, no immunity, sovereign or otherwise, from such proceedings, executions, attachment or other legal process shall be claimed by or on behalf of itself or with respect to any of its assets (other than the Exempted Assets);

 

(c)  consents generally in respect of the enforcement of any judgment against it in any proceedings in any jurisdiction to the giving of any relief or the issue of any process in connection with such proceedings including without limitation the making, enforcement or execution against or in respect of any property irrespective of its use or intended use subject to sub-clause (b) above .

 

 

Каждая сторона к настоящему Соглашению, безусловно и бесповоротно:

 

(a)  соглашается, что исполнение, поставка и выполнение ею данного Соглашения, и всех прочих договоров, контрактов, документов и письменных материалов, относящихся к данному Соглашению являются частными и коммерческими действиями, а не государственными или правительственными актами;

 

(b)  соглашается, что если будет начато какое-либо разбирательство, против неё или её активов, за вычетом активов, защищенных дипломатическими и консульскими привилегиями по Закону США о Иностранном Суверенном Иммунитете или любому аналогичному законодательству (“Исключённые активы") в любой юрисдикции, в отношении данного Соглашения или любых сделок, предусмотренными данным Соглашением, то никакого иммунитета суверенного ли или иначе, от таких разбирательств, исполнения, наложения ареста или иного судопроизводства не может быть затребовано напрямую или от своего имени или в отношении к любым своим активам, (за вычетом Исключённых активов);

 

(c)  в общем соглашается относительно исполнения против себя любого судебного решения, по любому судопроизводству в любой юрисдикции об удовлетворении требований или начале любых процессов в связи с такими разбирательствами, включая, без ограничения, вынесение, принудительное выполнение или исполнения решения против или в отношении любого имущества независимо от его использования или предполагаемого использования обусловленного действием подпункта (b) выше.

 

 
 

 

16.3   Any dispute arising out of or in connection with this Agreement, or the breach, termination or invalidity thereof, shall be finally settled by arbitration under the Rules of the International Centre for Dispute Resolution. The place of arbitration shall be Moscow, Russia Federation, and the English language shall be used in the proceedings. Any arbitration award shall be final and binding and may, if necessary, be enforced by any court or authority having competent jurisdiction. The parties undertake and agree that all arbitral proceedings conducted hereunder shall be kept strictly confidential, and all information, documentation, materials in whatever form disclosed in the course of the proceedings shall be used solely for the purpose of those proceedings. Notwithstanding the aforesaid, nothing in this Section 16.1 shall prevent a party from seeking injunctive or equitable relief by a court of competent jurisdiction.   Любой спор, вытекающий из настоящего Соглашения или возникающий в связи с ним, или с его нарушением, расторжением или недействительностью, окончательно решается путём арбитража, согласно Правилам Международного центра разрешения споров. Местом арбитражного разбирательства должна быть Москва, Российская Федерация, и судопроизводство должно будет производится на английском языке. Любое решение арбитражного суда является окончательным и обязательным для исполнения и при необходимости может быть принудительно исполнено любым судом или органом, имеющим соответствующую юрисдикцию. Стороны обязуются и соглашаются с тем, что все арбитражные процессы, которые будут проходить по настоящему Соглашению, должны оставаться строго конфиденциальными и что вся информация, документация и все материалы в любой форме, предоставленные в ходе процесса, должны использоваться исключительно для целей такого процесса. Невзирая на изложенное выше, ничто содержащееся в настоящем пункте 16.1 не запрещает стороне обращаться за принятием обеспечительных мер или средств судебной защиты по праву справедливости в суд соответствующей юрисдикции.
         
16.4   If any provision of this Agreement is held to be invalid, void or illegal, it will be severed from this Agreement and will not affect, impair or invalidate any other provision, and it will be replaced by a provision which comes closest to such severed provision in language and intent without being invalid, void or illegal. The parties hereby agree to waive trial by jury.   Если какое-либо положение настоящего Соглашения будет признано недействительным, не имеющим юридической силы или незаконным, то оно будет выделено из настоящего Соглашения и не будет влиять, ухудшать или делать недействительными любые другие положения, и оно будет заменено положением, наиболее близким по формулировке и смыслу к такому выделенному положению, но при этом не являющимся недействительным, не имеющим юридической силы или незаконным. Тем самым стороны соглашаются на отказ от рассмотрения дела с участием присяжных.

 

 
 

 

16.5   Neither this Agreement nor any of the rights or obligations hereunder may be transferred or assigned by any party without the prior express written consent of the other party, except that Manufacturer may assign this Agreement to an acquirer of a majority of the voting power of Manufacturer’s then outstanding capital securities or to a purchaser of all or substantially all of Manufacturer’s business or assets. Any purported transfer or assignment in violation of this section is void.   Ни настоящее Соглашение, ни какие либо права или обязанности, по нему, не могут передаваться или переуступаться ни одной из сторон без предварительного письменного согласия другой стороны, за исключением случаев, когда Изготовитель может переуступить данное Соглашение приобретателю большинства прав голоса по акционерному капиталу Изготовителя или покупателю всех или фактически всех активов или деятельности Изготовителя. Любая предполагаемая передача или любая предполагаемая переуступка в нарушение данного раздела не имеет юридической силы.
         
16.6   This Agreement will be binding upon and inure to the benefit of each of the parties and their respective permitted successors and permitted assigns. No right under this Agreement or breach hereof may be waived except in writing signed by the parties hereto. The failure of any party to require performance of any provision of this Agreement will not be construed as a waiver of such party’s rights to insist on performance of such provision or any other provision at some other time.   Настоящее Соглашение обязательно для исполнения и действительно в интересах каждой из сторон и их соответствующих разрешённых наследников и разрешенных правоприёмников. Никакого отказа от любого из прав, предусмотренных настоящим Соглашением или возникающих в случае его нарушения, не может произойти, если такой отказ не оформлен в письменной форме и не подписан сторонами данного Соглашения. Отсутствие требования о выполнении любого положения данного Соглашения одной из сторон, не будет истолковано как отказ данной стороной от прав настаивать на выполнении такого положения или любого другого положения в какое-либо другое время.
         
16.7   This Agreement, together with all documents referenced herein, constitutes the entire agreement and understanding among the parties regarding the subject matter addressed herein and supersedes and replaces all prior negotiations, understandings and agreements, proposed or otherwise, whether written or oral, concerning the subject matter hereof.   Настоящее Соглашение вместе со всеми документами, ссылки на которые содержатся в нем, составляет полное соглашение и взаимопонимание между сторонами в отношении предмета соглашения, рассматриваемого в данном Соглашении, и лишает силы и заменяет все предыдущие переговоры, взаимопонимания и соглашения, предполагаемые ли или нет, в письменной или устной форме, в отношении предмета данного Соглашения.
         
16.8   This Agreement may not be modified or varied except by a written document signed by all of the parties to this Agreement. This Agreement may be executed in counterparts, each of which will be deemed an original, but all of which taken together will constitute one and the same instrument.   Данное соглашение не может быть изменено или исправлено, кроме как посредством письменного документа, подписанного всеми сторонами данного Соглашения. Данное Соглашение может быть подписано в нескольких экземплярах, каждый из которых будет считаться оригиналом, но которые вместе взятые будут составлять один и тот же инструмент.

 

[Signature page follows.]

 

[Подписи - на следующей странице.]

 

 
 

 

IN WITNESS WHEREOF, Manufacturer, Hospital and Principal Surgeon have caused this Agreement to be executed as of the date set forth below.

 

В СВИДЕТЕЛЬСТВО ИЗЛОЖЕННОГО ВЫШЕ Изготовитель, Больница и Главный врач подписали настоящее Соглашение на дату, указанную ниже.

 

HOSPITAL/ БОЛЬНИЦА:   MANUFACTURER/ ИЗГОТОВИТЕЛЬ:
     
State Budget Institution of Public Health Department Regional Clinical Hospital #1/ Государственное бюджетное учреждение здравоохранения «Краевая клиническая больница №1 имени профессора С.В. Очаповского   Harvard Apparatus Regenerative Technology, Inc.
Signature/ Подпись:   Signature/ Подпись:
     
/s/ Vladimir Alekseevich Porhanov   /s/ Thomas W. McNaughton
     
Printed Name/ Ф.И.О. прописью:   Printed Name/ Ф.И.О. прописью:
     
Vladimir Alekseevich Porhanov   Thomas W. McNaughton
     
Title/ Должность:   Title/ Должность:
     
Principal Surgeon   Chief Financial Officer
     
Date Signed/ Дата подписания:   Date Signed/ Дата подписания:
     
21.05.2012   21 May 2012
     
PRINCIPAL SURGEON/ ГЛАВНЫЙ ВРАЧ:    
     
Signature/ Подпись:    
     
/s/ Vladimir Alekseevich Porhanov    
     
Printed Name/ Ф.И.О. прописью:    
     
Vladimir Alekseevich Porhanov    
     
Title/ Должность:    
     
Principal Surgeon    
     
Date Signed/ Дата подписания:    
     
21.05.2012    

 

 

 

 

EXHIBIT 10.22

Execution Copy

 

 

NOVEL SURGERY AGREEMENT

 

This Novel Surgery Agreement (“Agreement”) is made, as of the last date set forth on the signature page below, between Harvard Apparatus Regenerative Technology, Inc., a Delaware corporation having an office located at 84 October Hill Road, Holliston, Massachusetts 01746 Telephone: (508) 893-8999; Facsimile: (508) 892-6135 (“Manufacturer”), OSF Healthcare System, an Illinois not-for-profit corporation, owner and operator of Saint Francis Medical Center and Children’s Hospital of Illinois (“Hospital”), located at 530 N.E. Glen Oak Ave, Peoria, Illinois, 61637, and Mark Holterman, M.D., an employee of Hospital assigned to provide professional services at Hospital (“Principal Surgeon”).

 

WHEREAS, Principal Surgeon intends to employ a clinical protocol, entitled “Human Bioengineered Synthetic Tracheal Transplant Protocol”, as amended in writing from time to time and incorporated by reference herein (the “Clinical Protocol”), for the transplantation of the trachea, using a synthetic bioengineered scaffold seeded with autologous mononuclear cells (the “Surgery”), as an intraoperative solution for a patient (“Patient”);

 

WHEREAS, the Clinical Protocol contemplates the use of the In Breath® 3D Organ Bioreactor (the “Device”) in connection with the Surgery and Manufacturer owns the rights to and manufactures the Device;

 

WHEREAS, Hospital has facilities and personnel with the requisite skills experience and knowledge to participate in the Surgery in accordance with the Clinical Protocol referenced above; and

 

WHEREAS, the parties wish to collaborate on the Surgery in a manner beneficial to each of them.

 

NOW, THEREFORE, in consideration of the premises and mutual promises and covenants expressed herein the parties agree as follows:

 

Section 1 Surgery

 

1.1.          Principal Surgeon will perform the Surgery at the Hospital (or at such other location agreed to by the parties) according to the Clinical Protocol, the investigational plan (as defined in 21 C.F.R. §812.25), and the conditions of approval imposed by the reviewing Institutional Review Board (“IRB”) and/or the Food and Drug Administration (“FDA”), using his professional expertise and reasonable professional practices.

 

1.2.          Hospital will provide qualified personnel, equipment, and materials (except as otherwise provided by Manufacturer), and facilities necessary to perform the Surgery in accordance with the Clinical Protocol and this Agreement. Hospital and Principal Surgeon shall at all times comply with all applicable local, state and federal laws and regulations relating to the use of such equipment and materials, and shall at all times comply with the requirements for obtaining prior, written informed consent of the Patient and/or Patient’s representatives (“Informed Consent”) in accordance with the requirements of the FDA, the Department of Health and Human Services (“HHS”), any other applicable regulatory agencies, and the IRB reviewing the Surgery.

 

 
 

 

Section 2  Principal Surgeon

 

2.1.          The Surgery will be performed by and under the direction of Principal Surgeon.

 

2.2.           Hospital and Principal Surgeon represent and warrant that Principal Surgeon is not the subject of a proceeding by the Board of Medical Examiners or similar agency.

 

Section 3  IRB Approval

 

Hospital and Principal Surgeon shall not allow the Surgery nor any preparation for the Surgery until the IRB has unconditionally approved all the terms and conditions of the Surgery, including without limitation the Informed Consent of the Patient, the Clinical Protocol and the participation of Hospital and Principal Surgeon in the Surgery.

 

Section 4  Supply of Surgery Materials

 

Manufacturer will provide the Device, and Principal Surgeon and Hospital shall provide all other devices, services, equipment and other supplies necessary for conduct of the Surgery. Neither Principal Surgeon nor Hospital may provide or demonstrate the Device to any other persons or entities not described in this Agreement without the prior express written consent of Manufacturer.

 

Section 5 Access to Facilities and Personnel

 

5.1.          Hospital will allow Manufacturer (or its designees) reasonable access during business hours and at mutually convenient times to the Hospital (or such other location as the Surgery or any post-operative activities take place) and Principal Surgeon for the purpose of assisting Principal Surgeon and his team in use of the Device, monitoring the Surgery in accordance with the Clinical Protocol and/or the Informed Consent, reviewing documents and other matters related to the Surgery.

 

Section 6 Access to Surgery Reports and Results

 

6.1.          Hospital and Principal Surgeon agree to disclose and make available to Manufacturer (or its designee) all pre- and post-operative records, follow-up reports and other records concerning the Surgery prepared by Hospital or Principal Surgeon, either alone or with others, in each case consistent with the scope of the Informed Consent and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) authorization given by the Patient, for the purpose of Manufacturer’s use of such information to improve the Device or invent other devices for use in future procedures.

 

2
 

 

Section 7 Inventions; Ownership of Intellectual Property

 

7.1.          It is recognized and understood that the existing inventions and technologies, including, but not limited to the Confidential Information of Manufacturer or Hospital are their separate property, respectively, and are not affected by this Agreement. Hospital shall not have any claims to or rights in such existing inventions and technologies of Manufacturer (including, without limitation, Manufacturer’s Confidential Information), and Manufacturer shall not have any claims to or rights in such existing inventions and technologies of Hospital (including, without limitation, Hospital’s Confidential Information). For purposes hereof, “Confidential Information” shall mean any and all information, materials and data that is disclosed by one party to the other pursuant to this Agreement and designated as “confidential” at the time of initial disclosure if disclosed in writing or, if initially disclosed orally, identified by the disclosing party as confidential at the time of disclosure and thereafter summarized in writing and designated as “confidential” within 30 days after the initial oral disclosure. Confidential Information shall not include any information, materials or data which: (i) at the time of disclosure hereunder is generally available to the public; (ii) after disclosure hereunder becomes generally available to the public, except through breach of this Agreement by the recipient; (iii) the recipient can demonstrate was in its possession prior to the time of disclosure by the disclosing party hereunder, and was not acquired directly or indirectly from the disclosing party under an obligation of confidentiality; (iv) becomes available to the recipient from a third party which is not legally prohibited from disclosing such Confidential Information, provided such Confidential Information was not acquired directly or indirectly from the disclosing party under an obligation of confidentiality; or (v) the recipient can demonstrate was developed by or for the recipient independently of the disclosure of Confidential Information by the disclosing party.

 

7.2.          All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement shall belong solely to Manufacturer if conceived, discovered or invented solely by Manufacturer or an employee or consultant of Manufacturer. All right, title and interest to any invention, whether or not patentable, which arises from Manufacturer’s Confidential Information or the Device shall also be owned solely by Manufacturer (both referred to as a “Manufacturer Invention”).

 

7.3.          All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement shall belong solely to Hospital if conceived, discovered or invented solely by Hospital or an employee or consultant of Hospital, without any access to Manufacturer’s Confidential Information or use of Manufacturer’s technology, resources or other property (including, without limitation, the Device) (a “Hospital Invention”).

 

7.4.          All right, title and interest to any invention, whether or not patentable, resulting from the performance of this Agreement and which is conceived, discovered or invented jointly by Manufacturer or an employee or consultant of Manufacturer and Hospital or an employee or consultant of Hospital shall be owned jointly by Manufacturer and Hospital (a “Joint Invention”).

 

7.5.          Hospital hereby grants to Manufacturer an option to obtain a perpetual, worldwide license, to make, have made, use and sell products incorporating Hospital Inventions at a reasonable royalty rate and upon other reasonable terms, including exclusivity, to be negotiated by the parties. Manufacturer’s election to exercise its option must be in writing to Hospital. If, within ninety (90) days from the date Manufacturer is notified of a Hospital Invention, Hospital and Manufacturer do not execute a mutually agreeable license for such, Hospital may thereafter enter into a license with any third party with respect thereto.

 

3
 

 

7.6.          Hospital shall have a royalty-free, non-exclusive license to use any Manufacturer Inventions and/or Joint Inventions, solely for its internal educational and non-commercial research purposes and for the purpose of compliance with any applicable laws and regulations. With respect to all other uses, Manufacturer hereby grants to Hospital an option to obtain a perpetual, worldwide license, to Manufacturer Inventions at a reasonable royalty rate and upon other reasonable terms, including exclusivity, to be negotiated by the parties. Hospital’s election to exercise its option must be in writing to Manufacturer. If, within ninety (90) days from the date Hospital is notified of a Manufacturer Invention, Hospital and Manufacturer do not execute a mutually agreeable license for such, Manufacturer may thereafter enter into a license with any third party with respect thereto.

 

7.7.          Each party shall have the unrestricted right to exploit any Joint Inventions.

 

Section 8 Documentation Provided by Hospital.

 

Hospital will submit the following documents to Manufacturer before commencing the Surgery:

 

(a)          a signed copy of IRB approval of the Surgery and Patient Informed Consent form, as approved by the IRB; and

 

(b)          a signed copy of the Clinical Protocol.

 

Section 9 Privacy

 

9.1.          Manufacturer hereby agrees to fully comply with all Federal laws relating to privacy of Patient health information, including but not limited to HIPAA and the regulations adopted pursuant thereto. Without any limitation to the foregoing, the parties understand that in connection with the Agreement, certain Patient data must be exchanged between Hospital and Manufacturer. Manufacturer agrees to fully comply with HIPAA and regulations, and specifically agrees to:

 

(a)          not use or further disclose Patient health information and/or electronic protected health information other than as permitted or required by the Agreement or as required by law;

 

(b)          use appropriate safeguards to prevent use or disclosure of information other than as required for by the Agreement;

 

(c)          report to the Hospital any use or disclosure of the information not provided for by the Agreement of which it becomes aware,

 

(d)          ensure that any agents, including a subcontractor, to whom Manufacturer provides protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital, agree to the Manufacturer’s restrictions and conditions that apply to Manufacturer as a business partner of Hospital under HIPAA with respect to such information;

 

4
 

 

(e)          make available protected health information and/or electronic protected health information for amendment and incorporate any amendments to protected health information and/or electronic protected health information in accordance with 45 C.F.R. §164.526.

 

(f)          make its internal practices, books and records related to the use and disclosure of protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital available to the Secretary of Health and Human Services for the purpose of determining Hospital’s compliance with this subpart;

 

(g)          return or destroy, at termination of this Agreement, if feasible, all protected health information and/or electronic protected health information received from, or created, or received by Manufacturer on behalf of Hospital that Manufacturer still maintains in any form and retain no copies of such information; or, if such return or destruction is not feasible, extend the protection of the Agreement to the information and limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible.

 

9.2.          A violation of this section shall be a material violation of this Agreement and cause for termination notwithstanding any provision in the Agreement to the contrary.

 

9.3.          Manufacturer also agrees that if it becomes necessary to amend this Agreement to fulfill the purposes of the HIPAA law and regulations that Manufacturer agrees to do so without additional consideration.

 

Section 10  Device Not Offered for Sale or Public Use

 

Without limiting the generality of any other confidentiality provisions under this Agreement, Hospital and Principal Surgeon acknowledge that the Device is investigational and agree not to offer the Device for commercial sale or use.

 

Section 11 Insurance

 

11.1.          Principal Surgeon shall maintain, during the course of this Agreement and for a period of at least two (2) years thereafter, professional liability insurance in the amount of One Million Dollars ($1,000,000) per occurrence and Three Million Dollars ($3,000,000 annual aggregate, through Principal Surgeon’s employer (Hospital) or otherwise, either through Hospital’s self-insurance plan, or with financially sound and reputable insurance companies or as may be required by applicable laws and/or regulations. Upon request, Principal Surgeon shall provide certification of such insurance coverage to Manufacturer.

 

11.2.          Hospital shall maintain, during the course of this Agreement and for a period of at least two (2) years thereafter, its program of self insurance against such risks in minimum amounts of Two Million Dollars ($2,000,000) per occurrence and Four Million Dollars ($4,000,000) annual aggregate or in such other amounts as may be required by applicable laws and/or regulations. Upon request, Hospital shall provide certification of such insurance coverage to Manufacturer.

 

11.3.          Manufacturer shall maintain, during the course of this Agreement and for a period of at least two (2) years thereafter, liability insurance in the amount of Two Million Dollars ($2,000,000) per occurrence and Four Million Dollars ($4,000,000) annual aggregate with financially sound and reputable insurance companies. Upon request, Manufacturer shall provide certification of such insurance coverage to Hospital.

 

5
 

 

Section 12 Indemnification and Responsibility

 

12.1.      By Manufacturer:

 

(a)          Manufacturer hereby agrees to indemnify, defend and hold harmless Hospital and its directors, trustees, officers, shareholders, agents, and employees, including, but not limited to Principal Surgeon and assistants in the Surgery (hereafter collectively referred to as “Hospital Indemnitees”) from and against any and all claims, liabilities, losses, judgments, obligations, damages, costs and expenses (including reasonable attorneys’ fees) (collectively “Claims”) arising out of claims made or brought on behalf of Patient (or his representatives or dependents) for personal injury (including death) that arises from or is attributable to the design, production, manufacture of the Device.

 

(b)          The indemnification obligation set forth in this Section 12.1 shall not apply in the event and to the extent that such Claims arose as a result of (i) the willful misconduct or negligence by Hospital Indemnitees or (ii) the “sole negligence” of one or any of the Hospital Indemnitees.

 

(c)          Hospital Indemnitees shall provide Manufacturer written notice of a Claim no later than fourteen (14) days after the Hospital Indemnitees have notice of such Claim for which indemnification is sought.

 

(d)          Manufacturer shall have sole control over the defense and settlement of a Claim for which indemnification is sought, and Hospital Indemnitees shall cooperate with the Manufacturer and its legal representatives in the investigation and defense of the Claim.

 

(e)          Manufacturer shall act reasonably and in good faith with respect to the defense or settlement of the Claim and will not reach any settlement which requires an admission of fault by a Hospital Indemnitee without that Hospital Indemnitee’s consent.

 

(f)          Hospital Indemnitees may, at their own expense, obtain separate legal counsel.

 

12.2.      By Hospital and Principal Surgeon:

 

(a)          Hospital and Principal Surgeon hereby agree to indemnify, defend and hold harmless Manufacturer and its directors, officers, shareholders, agents, and employees (hereafter collectively referred to as “Manufacturer Indemnitees”) from and against any and all Claims arising out of claims made or brought on behalf of Patient (or his dependents) for personal injury (including death) that arises from or is attributable to the services provided by Hospital and Principal Surgeon in connection with the Surgery.

 

(b)          The indemnification obligation set forth in this Section 12.2 shall not apply in the event and to the extent that such Claims arose as a result of (i) the willful misconduct or negligence by Manufacturer Indemnitees; (ii) the “sole negligence” of one or any of the Manufacturer Indemnitees; or (iii) the design, production or manufacture of the Device by any of the Manufacturer Indemnitees.

 

6
 

 

(c)          Manufacturer Indemnitees shall provide Manufacturer written notice of a Claim no later than fourteen (14) days after the Manufacturer Indemnitees have notice of such Claim for which indemnification is sought.

 

(d)          Hospital and Principal Surgeon shall have sole control of the defense and settlement of a Claim for which indemnification is sought, and Manufacturer Indemnitees shall cooperate with the Hospital, Principal Surgeon and their legal representatives in the investigation and defense of the Claim.

 

(e)          Hospital and Principal Surgeon shall act reasonably and in good faith with respect to the defense or settlement of the Claim and will not reach any settlement which requires an admission of fault by a Manufacturer Indemnitee without that Manufacturer Indemnitee’s consent.

 

(f)          Manufacturer Indemnitees may, at their own expense, obtain separate legal counsel.

 

12.3.       The obligations of the parties under this Section 12 shall survive the termination of the Agreement.

 

Section 13 Fees

 

13.1.       Manufacturer waives its fees for the use of the Device and Manufacturer’s involvement in the Surgery.

 

Section 14 Notices

 

All notices or consents required or permitted by this Agreement shall be in writing in the English language, and shall be deemed given when delivered in person or deposited in first class registered or certified mail, return receipt requested, postage prepaid, or by recognized international, commercial, overnight courier, or given by facsimile with a confirmation copy, by regular mail addressed to such party at the address set forth below, unless such address is changed from time to time by written notice hereunder:

 

If to Manufacturer:

 

Thomas W. McNaughton, Chief Financial Officer

Harvard Apparatus Regenerative Technology, Inc.

84 October Hill Road

Holliston, MA 01746

Tel: 508-893-8999

Fax: 508-892-6135

 

7
 

 

If to Hospital:

 

OSF Saint Francis Medical Center

 

530 NE Glen Oak Ave.

 

Peoria, IL 61637

 

Attn: Stephanie Madrigal, Director Clinical Research

 

If to Principal Surgeon:

 

OSF Saint Francis Medical Center

530 NE Glen Oak Ave.

Peoria, IL 61637

Attn: Mark Holterman, MD

(Research #80114)

 

Section 15 Legal proceeding reimbursement

 

In the event that Hospital is requested or authorized by Manufacturer or required by government regulation, subpoena, or other legal process to produce documents or any Hospital personnel in any legal proceeding with respect to the Surgery, or Manufacturer’s use of the results of the Surgery, or pursuant to this Agreement, Manufacturer will, so long as Hospital is not a party to the proceeding in which the information is sought, reimburse Hospital for its time and expense, as well as the fees and expenses of its counsel incurred in responding to such a request.

 

Section 16 Miscellaneous

 

16.1.          If any provision of this Agreement is held to be invalid, void or illegal, it will be severed from this Agreement and will not affect, impair or invalidate any other provision, and it will be replaced by a provision which comes closest to such severed provision in language and intent without being invalid, void or illegal. The parties hereby agree to waive trial by jury.

 

16.2.          Neither this Agreement nor any of the rights or obligations hereunder may be transferred or assigned by any party without the prior express written consent of the other party, except that Manufacturer may assign this Agreement to an acquirer of a majority of the voting power of Manufacturer’s then outstanding capital securities or to a purchaser of all or substantially all of Manufacturer’s business or assets. Any purported transfer or assignment in violation of this section is void.

 

16.3.          This Agreement will be binding upon and inure to the benefit of each of the parties and their respective permitted successors and permitted assigns. No right under this Agreement or breach hereof may be waived except in writing signed by the parties hereto. The failure of any party to require performance of any provision of this Agreement will not be construed as a waiver of such party’s rights to insist on performance of such provision or any other provision at some other time.

 

16.4.          This Agreement, together with all documents referenced herein, constitutes the entire agreement and understanding among the parties regarding the subject matter addressed herein and supersedes and replaces all prior negotiations, understandings and agreements, proposed or otherwise, whether written or oral, concerning the subject matter hereof.

 

8
 

 

16.5.          This Agreement may not be modified or varied except by a written document signed by all of the parties to this Agreement. This Agreement may be executed in counterparts, each of which will be deemed an original, but all of which taken together will constitute one and the same instrument.

 

9
 

 

IN WITNESS WHEREOF, Manufacturer, Hospital and Principal Surgeon have caused this Agreement to be executed as of the date set forth below.

 

HOSPITAL:   MANUFACTURER:
     
OSF Healthcare System, Saint Francis Medical   Harvard Apparatus Regenerative
Center and Children’s Hospital of Illinois   Technology, Inc.

 

Signature: /s/ Tim Miller   Signature: /s/ Thomas McNaughton
         
Printed Name: Tim Miller, MD   Printed Name: Thomas McNaughton
         
Title: VP, CMO   Title: CFO
         
Date Signed: 5/3/12   Date signed: 5/24/12
         
PRINCIPAL SURGEON:      
         
Signature: /s/ Mark J. Holterman      
         
Printed Name: Mark J. Holterman      
         
Title: M.D.      
         
Date signed: 5/7/12      

 

10

 

   

Exhibit 21

 

Subsidiaries of the Registrant

 

None

 

 

 

Exhibit 23.1

 

 

Consent of Independent Registered Public Accounting Firm

 

The Board of Directors

Harvard Bioscience, Inc.:

 

We consent to the use of our report dated December 11, 2012, with respect to the balance sheets of Harvard Apparatus Regenerative Technology, Inc., a business segment of Harvard Bioscience, Inc. and development stage company, as of December 31, 2011 and 2010, and the related statements of operations, invested equity (deficit), and cash flows for the years ended December 31, 2011 and 2010, for the period from February 24, 2009 (inception) to December 31, 2009 and for the period from February 24, 2009 (inception) to December 31, 2011, included herein and to the reference to our firm under the heading “Experts” in the prospectus.

 

 

/s/ KPMG LLP

 

Boston, Massachusetts
February 15, 2013