ABII » Topics » Clinical Trial and Other Commitments

These excerpts taken from the ABII 10-K filed Mar 12, 2010.

Clinical Trial and Other Commitments

We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2010 through 2014 would approximate $83.0 million. In addition, we own a

 

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library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to this library.

Clinical Trial and Other Commitments

We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2010 through 2014 would approximate $83.0 million. Based on our current estimates of patient enrollment, approximately $53.4 million would be payable in 2010, approximately $24.1 million would be payable in 2011, approximately $2.9 million would be payable in 2012, approximately $1.5 million would be payable in 2013 and approximately $1.1 million would be payable in 2014.

We own a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to these libraries, which we expect to occur within the next five years.

We have entered into various collaborative agreements under which we have agreed to provide funding to academic and clinical trial organizations of up to $53.8 million for research and other projects over the next five years. Even though we cannot predict the timing, we generally can control the timing and amount of spending as the projects require our approval in advance of funding.

These excerpts taken from the ABII 10-K filed Mar 6, 2009.

Clinical Trial and Other Commitments

We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2009 through 2013 would approximate $42.6 million. In addition, we own a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to this library.

Clinical Trial and Other Commitments

FACE="Times New Roman" SIZE="2">We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of
patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2009 through 2013 would approximate $42.6 million. In addition, we own a library of natural drug
discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to
this library.

Clinical Trial and Other Commitments

We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone

 

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commitments to be paid by us in 2009 through 2013 would approximate $42.6 million. Based on our current estimates of patient enrollment, approximately $8 million would be payable in 2009, approximately $13.6 million would be payable in 2010, approximately $9 million would be payable in 2011, approximately $6 million would be payable in 2012 and approximately $6 million would be payable in 2013.

We own a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to these libraries, which we expect to occur within the next five years.

We have entered into various collaborative agreements under which we have agreed to provide funding to academic and clinical trial organizations of up to $65.5 million for research and other projects over the next five years. Even though we cannot predict the timing, we generally can control the timing and amount of spending as the projects require our approval in advance of funding.

Clinical Trial and Other Commitments

SIZE="2">We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the
clinical study. If all milestones in these agreements were achieved, related milestone

 


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commitments to be paid by us in 2009 through 2013 would approximate $42.6 million. Based on our current estimates of patient enrollment, approximately $8
million would be payable in 2009, approximately $13.6 million would be payable in 2010, approximately $9 million would be payable in 2011, approximately $6 million would be payable in 2012 and approximately $6 million would be payable in
2013.

We own a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for
use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to these libraries, which we expect to occur within the next five years.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">We have entered into various collaborative agreements under which we have agreed to provide funding to academic and clinical trial organizations of up to
$65.5 million for research and other projects over the next five years. Even though we cannot predict the timing, we generally can control the timing and amount of spending as the projects require our approval in advance of funding.

STYLE="margin-top:18px;margin-bottom:0px">9. Employee Benefit Plan

Following the 2007
separation, we adopted and our employees became eligible to participate in a defined contribution plan intended to be tax-qualified. APP cooperated with us to transfer the account balances of our employees to the defined contribution plan adopted by
us. We adopted the defined contribution plan in the first quarter of 2008. Prior to the 2007 separation, Old Abraxis sponsored a 401(k) defined-contribution plan, or 401(k) Plan, covering substantially all eligible employees. Employee contributions
to the 401(k) Plan are voluntary. Participants’ contributions are limited to their annual tax deferred contribution limit as allowed by the Internal Revenue Service. Our total matching contributions to our 401(k) Plan in 2008 and Old
Abraxis’ 401(k) Plan in 2007 and 2006 were $1.8 million, $1.4 million and $0.9 million for the years ended December 31, 2008, 2007 and 2006, respectively.

FACE="Times New Roman" SIZE="2">10. Stockholders’ Equity

For all periods prior to November 13, 2007, Old Abraxis’
investment in our proprietary products businesses is shown as parent company investment in the consolidated and combined financial statements. Parent company investment represents the historical investment of capital in us, our accumulated net
earnings after taxes, and the net effect of transactions with and allocations from Old Abraxis. See Note 7—Related Party Transactions for additional information regarding the allocation to us of various expenses incurred by Old
Abraxis.

On November 13, 2007, Old Abraxis completed a distribution of one share of our common stock (par value of $0.001) for every
four shares of Old Abraxis common stock. Following the separation, we had 40.0 million shares of common stock outstanding. After the separation adjustments were recorded on November 13, 2007, the remaining parent company investment
balance, which includes all earnings prior to the separation, was transferred to additional paid in capital. Net (loss) income subsequent to the separation is included in retained earnings.

STYLE="margin-top:18px;margin-bottom:0px; margin-left:2%">Registration Rights

Pursuant
to a registration rights agreement, Old Abraxis granted registration rights to the former ABI stockholders (including our Chief Executive Officer and entities affiliated with him) with respect to all 86,096,523 shares of Old Abraxis common stock
they received in the 2006 Merger. Under the terms of the registration rights agreement, any securities issued or issuable in respect of Old Abraxis common stock (including our common stock) would have the benefits of the registration rights
agreement. Accordingly, in connection with the separation, we entered into a new registration rights agreement with the former ABI shareholders with respect to 21,524,130 shares of our common stock containing provisions substantially identical to
the registration rights agreement entered into in connection with the 2006 Merger.

 


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These stockholders have the right to require us to register all or a portion of the shares of our common
stock they receive in the distribution. In addition, these stockholders may require us to include their shares in future registration statements that we file and may require us to register their shares for resale on a Form S-3 registration
statement. Upon registration, the registered shares generally will be freely tradeable in the public market without restriction. However, in connection with any underwritten offering, the stockholders will agree to lock up any other shares for up to
90 days and will agree to a limit on the maximum number of shares that can be registered for the account of these holders under so-called “shelf” registration statements.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Except for underwriters discounts and commissions and certain marketing expenses, we will be obligated to pay all expenses for the first eight
registration statements filed upon the request of a holder of registrable securities, and any other or additional expenses of registration are to be borne by the holders of registrable securities on a pro rata basis. These registration rights are
subject to some conditions and limitations, among them the right of the underwriters of an offering to limit the number of shares included in registration. We will be obligated to indemnify the holders of these registration rights, and each selling
holder will be obligated to indemnify us, against specified liabilities under the Securities Act of 1933, the Securities Exchange Act of 1934 and other applicable federal and state laws.

FACE="Times New Roman" SIZE="2">11. Stock-Based Compensation

These excerpts taken from the ABII 10-K filed Mar 31, 2008.

Clinical Trial and Other Commitments

FACE="Times New Roman" SIZE="2">We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of
patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2008 through 2012 would approximate $29.8 million. In addition, we own a library of natural drug
discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to
this library.

Clinical Trial and Other Commitments

We have entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patients enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by us in 2008 through 2012 would approximate $29.8 million. Based on our current estimates of patient enrollment, approximately $17.3 million would be payable in 2008, approximately $7.1 million would be payable in 2009, approximately $3.4 million would be payable in 2010, approximately $1.8 million would be payable in 2011 and approximately $0.2 million would be payable in 2012.

We own a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. We are committed to paying up to $4.2 million upon the achievement of certain milestones related to these libraries, which we expect to occur within the next five years.

We have entered into various collaborative agreements under which we have agreed to provide funding to academic and clinical trial organizations of up to $65.2 million for research and other projects over periods of time of up to six years. Even though we cannot predict the timing, we generally can control the timing and amount of spending as the projects require our approval in advance of funding.

This excerpt taken from the ABII 8-K filed Nov 8, 2007.

Clinical Trial and Other Commitments

New Abraxis has entered into various clinical trial agreements with third parties for the management, planning and execution of clinical trials. These agreements generally include milestone payments based on the number of patient enrolled in the clinical study. If all milestones in these agreements were achieved, related milestone commitments to be paid by New Abraxis in 2007 through 2011 would approximate $5.4 million. Based on New Abraxis’ current estimates of patient enrollment, approximately $3.4 million would be payable in 2007, approximately $1.2 million would be payable in 2008, approximately $0.5 million would be payable in 2009 and less than $0.2 million would be payable in each of 2010 and 2011.

New Abraxis owns a library of natural drug discovery soil samples and related strains acquired from around the world, which is intended for use in the discovery of new chemical entities. New Abraxis is committed to paying up to $4.2 million upon the achievement of certain milestones related to these libraries.

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