UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549  
 ___________________________________________________________________
FORM 10-Q
 
x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934  
For the quarterly period ended June 30, 2019
OR
o          Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 ___________________________________________________________________

Commission File Number 001-31564
FCSCCOLORLOGOA15.JPG
Fibrocell Science, Inc.
(Exact name of registrant as specified in its Charter)
Delaware
 
87-0458888
(State or other jurisdiction of incorporation)
 
(I.R.S. Employer Identification No.)
405 Eagleview Boulevard
Exton, Pennsylvania 19341

(Address of principal executive offices, including zip code)
(484) 713-6000
(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001
FCSC
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for any shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  ý   No  o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Y es  ý   No  o












Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer, smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer o
 
Accelerated filer o
 
 
 
                         Non-accelerated filer  ý
 
Smaller reporting company  ý
 
 
 
 
 
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2of the Exchange Act). Yes  o   No  ý
As of August 7, 2019, there were 9,758,332 outstanding shares of the registrant’s common stock, par value $0.001.
 



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Fibrocell Science, Inc.

TABLE OF CONTENTS
 
 
 
PAGE
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_____________________________
Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q (this Form 10-Q) to the “Company,” “Fibrocell,” “we,” “us,” and “our” include Fibrocell Science, Inc. and its subsidiaries.
Trademark Notice
Fibrocell ® , Fibrocell Science ® , the Fibrocell logo and LAVIV ® are trademarks of Fibrocell Science, Inc. (Exton, PA). All other trademarks, service marks or trade names appearing in this Form 10-Q are the property of their respective owners.



Table of Contents

EXPLANATORY NOTE
The information contained in “Item 1 - Financial Statements” of this Form 10-Q gives retroactive effect to a one-for-five reverse stock split of our issued and outstanding shares of common stock effected on May 24, 2018. See Note 1 of the Notes to Condensed Consolidated Financial Statements for further information.
NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform
Act of 1995. These statements include, among others, statements relating to:
our expectation that our existing cash resources will be sufficient to enable us to fund our operations into the third quarter of 2020;

our future expenses and capital expenditures;

our estimates regarding expenses, future revenues, capital requirements and needs for, and ability to obtain, additional financing;

our plans to address our future capital requirements and the consequences of failing to do so;

our projection to complete enrollment and dosing of Phase 3 patients in the third quarter of 2020 and complete data collection for the primary endpoint in the fourth quarter of 2020;

our expectation to file a Biologics License Application (BLA) for FCX-007 in 2021 if the Phase 3 clinical trial is successful and completed within our projected timeframe;

the potential benefits of the co-development and license agreement (CCP Agreement) between us and Castle Creek Pharmaceuticals, LLC (CCP);

the potential to earn future milestone and profit share payments under the CCP Agreement;

our plans to complete enrollment of Phase 1 adult patients in a Phase 1/2 clinical trial for FCX-013 in the third quarter of 2019;

our projection that safety and efficacy data from adult patients in the Phase 1 portion of the clinical trial of FCX-013 will be available in mid-2020;

our product development goals under our collaborations with Intrexon Corporation for our product candidates;

the potential benefits of Fast Track, Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy (RMAT) designations;

the potential advantages of our product candidates and technologies; and

the effect of legal and regulatory developments;

as well as other statements relating to our future operations, financial performance and financial condition, prospects, strategies, objectives or other future events. Forward-looking statements appear primarily in the sections of this Form 10-Q entitled “Item 1—Financial Statements,” and “Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In some cases, you can identify forward-looking statements by words such as “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “scheduled” and similar expressions, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based upon current expectations and assumptions and are subject to a number of known and unknown risks, uncertainties and other factors that could cause actual results to differ materially and adversely from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this Form 10-Q, our Annual Report on Form 10-K for the fiscal year ended December 31, 2018

4

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(the 2018 Form 10-K), and in particular, the risks and uncertainties discussed under the caption “Item 1A—Risk Factors” of this Form 10-Q and our 2018 Form 10-K. As a result, you should not place undue reliance on forward-looking statements.

Additionally, the forward-looking statements contained in this Form 10-Q represent our views only as of the date of this Form 10-Q (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, even if new information becomes available in the future. However, you are advised to consult any further disclosures we make on related subjects in the periodic and current reports that we file with the Securities and Exchange Commission (SEC).

The foregoing cautionary statements are intended to qualify all forward-looking statements wherever they may appear in this Form 10-Q. For all forward-looking statements, we claim protection of the safe harbor for the forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

This Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.

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Table of Contents

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
Fibrocell Science, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
($ in thousands, except share and per share data)

 
June 30,
2019
 
December 31,
2018
Assets
 

 
 

Current assets:
 

 
 

Cash and cash equivalents
$
13,675

 
$
14,430

Accounts receivable
1,911

 

Contract asset - current
8,439

 

Prepaid expenses and other current assets
841

 
105

Total current assets
24,866

 
14,535

Property and equipment, net of accumulated depreciation of $2,479 and $2,311, respectively
1,289

 
1,222

Right of use asset - operating lease
4,421

 

Contract asset - long term
4,279

 

Other assets
1

 
1

Total assets
$
34,856

 
$
15,758

 
 
 
 
Liabilities and Stockholders’ Equity
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
1,085

 
$
452

Related party payable
3,815

 
100

Income taxes payable
634

 

Accrued expenses
1,381

 
1,470

Lease liability, current - operating lease
186

 

Deferred rent, current

 
150

Total current liabilities
7,101

 
2,172

Convertible promissory notes, net of debt discount of $18,003 and $18,003, respectively (see Note 6)

 

Accrued interest payable
2,134

 
1,738

Warrant liability
144

 
152

Derivative liability
2,557

 
1,474

Lease liability, operating lease
5,057

 

Deferred rent

 
665

Total liabilities
16,993

 
6,201

 
 
 
 
Stockholders’ equity:
 

 
 

Preferred stock, $0.001 par value; 5,000,000 shares authorized:
 
 
 
Series A nonredeemable convertible preferred stock; 8,000 shares designated, 8,000 shares issued and outstanding as of June 30, 2019 and December 31, 2018 respectively; aggregate liquidation preference of $8,771 at June 30, 2019 and $8,600 at December 31, 2018.

 

Common stock, $0.001 par value; 150,000,000 shares authorized, 9,758,332 shares issued and outstanding at June 30, 2019 and December 31, 2018.
10

 
10

Additional paid-in capital
198,856

 
198,627

Accumulated deficit
(181,003
)
 
(189,080
)
Total stockholders’ equity
17,863

 
9,557

Total liabilities and stockholders’ equity
$
34,856

 
$
15,758

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


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Fibrocell Science, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
($ in thousands, except share and per share data)

 
Three Months Ended
June 30,
 
Six Months Ended
June 30,
 
2019
 
2018
 
2019
 
2018
License revenue
$
20,979

 
$

 
$
20,979

 
$

Collaboration revenue
813

 

 
813

 

Total revenues
21,792

 

 
21,792

 

 
 
 
 
 
 
 
 
Cost of license - related party
3,750

 

 
3,750

 

Cost of collaboration revenue
1,355

 

 
1,355

 

Cost of collaboration revenue - related party
67

 

 
67

 

Total cost of revenue
5,172

 

 
5,172

 

 
 
 
 
 
 
 
 
Gross profit
16,620

 

 
16,620

 

 
 
 
 
 
 
 
 
Research and development expense
600

 
1,415

 
2,543

 
3,060

Research and development expense - related party (see Note 10)
(4
)
 
106

 
40

 
(197
)
Selling, general and administrative expense
2,456

 
1,556

 
4,326

 
3,195

Operating income (loss)
13,568

 
(3,077
)
 
9,711

 
(6,058
)
Other income (expense):
 
 
 
 
 
 
 
Warrant revaluation income
37

 
91

 
8

 
326

Derivative revaluation income (expense)
(1,138
)
 
242

 
(1,083
)
 
179

Interest expense
(200
)
 
(191
)
 
(397
)
 
(381
)
Other income, net
110

 
41

 
472

 
139

Income (loss) before income taxes
12,377

 
(2,894
)
 
8,711

 
(5,795
)
Income tax (expense)
(634
)
 

 
(634
)
 

Net income (loss)
11,743

 
(2,894
)
 
8,077

 
(5,795
)
Dividend paid in-kind to preferred stockholders
(86
)
 
(83
)
 
(171
)
 
(165
)
Deemed dividend on preferred stock (see Note 12)
(145
)
 
(126
)
 
(285
)
 
(247
)
Net income (loss) attributable to common stockholders
$
11,512

 
$
(3,103
)
 
$
7,621

 
$
(6,207
)
 
 
 
 
 
 
 
 
Per Share Information:
 
 
 
 
 
 
 
Net income (loss):
 
 
 
 
 
 
 
     Basic
$
1.18

 
$
(0.49
)
 
$
0.78

 
$
(1.03
)
     Diluted
$
1.12

 
$
(0.49
)
 
$
0.77

 
$
(1.03
)
Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
     Basic
9,758,332

 
6,376,048

 
9,758,332

 
6,026,454

     Diluted
11,697,391

 
6,376,048

 
10,509,881

 
6,026,454



The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.



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Fibrocell Science, Inc.
Condensed Consolidated Statement of Stockholders’ Equity (Deficit)
(unaudited)
($ in thousands, except share data) 


 
Series A Convertible
Preferred Stock
 
Common Stock
 
Additional paid-in capital
 
Accumulated deficit
 
Total Equity
 
Shares
 
Amount
 
Shares
 
Amount
 
 
 
Balance, December 31, 2017
8,000

 
$

 
5,189,755

 
$
26

 
$
187,784

 
$
(178,803
)
 
$
9,007

Effect of the May 2018 reverse stock split on common stock and additional paid in capital, beginning balance

 

 

 
(20
)
 
20

 

 

Stock-based compensation expense

 

 

 

 
129

 

 
129

Conversion of pre-funded warrants

 

 
483,221

 

 
24

 

 
24

Net loss

 

 

 

 

 
(2,901
)
 
(2,901
)
Balance, March 31, 2018
8,000

 
$

 
5,672,976

 
$
6

 
$
187,957

 
$
(181,704
)
 
$
6,259

Stock-based compensation expense

 

 

 

 
131

 

 
131

May 2018 Registered Direct Offering, net of offering costs of $627

 

 
2,038,224

 
2

 
5,371

 

 
5,373

Exercise of warrants

 

 
129,702

 

 
499

 

 
499

Net loss

 

 

 

 

 
(2,894
)
 
(2,894
)
Balance, June 30, 2018
8,000

 
$

 
7,840,902

 
$
8

 
$
193,958

 
$
(184,598
)
 
$
9,368




 
Series A Convertible
Preferred Stock
 
Common Stock
 
Additional paid-in capital
 
Accumulated deficit
 
Total Equity
 
Shares
 
Amount
 
Shares
 
Amount
 
 
 
Balance, December 31, 2018
8,000

 
$

 
9,758,332

 
$
10

 
$
198,627

 
$
(189,080
)
 
$
9,557

Stock-based compensation expense

 

 

 

 
112

 

 
112

Net loss

 

 

 

 

 
(3,666
)
 
(3,666
)
Balance, March 31, 2019
8,000

 
$

 
9,758,332

 
$
10

 
$
198,739

 
$
(192,746
)
 
$
6,003

Stock-based compensation expense

 

 

 

 
117

 

 
117

Net income

 

 

 

 

 
11,743

 
11,743

Balance, June 30, 2019
8,000

 
$

 
9,758,332

 
$
10

 
$
198,856

 
$
(181,003
)
 
$
17,863

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.



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Fibrocell Science, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
($ in thousands) 
 
Six months ended June 30,
 
2019
 
2018
Cash flows from operating activities:
 

 
 

Net income (loss)
$
8,077

 
$
(5,795
)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
 

 
 

Stock-based compensation expense
229

 
260

Warrant revaluation income
(8
)
 
(326
)
Derivative revaluation expense (income)
1,083

 
(179
)
Depreciation and amortization of long lived assets
168

 
202

Decrease (increase) in operating assets:
 

 
 

Accounts receivable
(1,911
)
 

Contract asset
(12,718
)
 

Prepaid expenses and other current assets
(706
)
 
30

Increase (decrease) in operating liabilities:
 
 
 
Accounts payable
485

 
51

Related party payable
3,715

 
(2,027
)
Income taxes payable
634

 

Accrued expenses, deferred rent
(67
)
 
(74
)
Accrued lease liabilities - operating lease
(23
)
 

Accrued interest payable
396

 
382

Net cash used in operating activities
(646
)
 
(7,476
)
Cash flows from investing activities:
 

 
 

Purchase of property and equipment
(87
)
 
(83
)
Net cash used in investing activities
(87
)
 
(83
)
Cash flows from financing activities:
 

 
 

Payment of deferred offering costs
(22
)
 
(444
)
Proceeds from conversion of pre-funded warrants

 
24

Proceeds from conversion of common warrants

 
499

Proceeds from May 2018 Registered Direct Offering, net of offering costs of $527

 
5,473

Net cash provided by (used in) financing activities
(22
)
 
5,552

Effect of exchange rate changes on cash balances

 

Net decrease in cash and cash equivalents
(755
)
 
(2,007
)
Cash and cash equivalents, beginning of period
14,430

 
17,417

Cash and cash equivalents, end of period
$
13,675

 
$
15,410

 
 
 
 
Supplemental disclosures of cash flow information:
 
 
 
Non-cash investing and financing activities:
 
 
 
Property and equipment in accounts payable
$
157

 
$
52

Offering costs in accounts payable and accrued expenses
$
15

 
$
100

Dividend paid in-kind to preferred stockholders
$
171

 
$
165

Deemed dividend on preferred stock
$
285

 
$
247

 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)


Note 1. Business and Organization

Organization

Fibrocell Science, Inc. (as used herein, “we,” “us,” “our,” “Fibrocell” or the “Company”) is the parent company of Fibrocell Technologies, Inc. (Fibrocell Tech). Fibrocell Tech is the parent company of Isolagen International, S.A., a company organized under the laws of Switzerland (Isolagen Switzerland). The Company’s international activities are currently immaterial.

Business Overview
    
Fibrocell is a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. The Company is utilizing its proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease.  Fibrocell’s pipeline of localized gene therapy candidates include FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a life-threatening genetic disorder diagnosed in infancy with no cure or treatment approved by the FDA. Fibrocell is also developing FCX-013 for the treatment of moderate to severe localized scleroderma.  Currently, Fibrocell’s research and development operations and focus are on gaining regulatory approvals to commercialize its gene therapy candidates in the United States; however, the Company may seek to expand into international markets in the future.

On April 12, 2019, the Company entered into a co-development and license agreement (CCP Agreement) with Castle Creek Pharmaceuticals, LLC (CCP) with respect to the development and commercialization of the Company’s lead gene therapy candidate, FCX-007, for the treatment of (RDEB).

Under the terms of the CCP Agreement, CCP will receive an exclusive license to commercialize FCX-007 in the United States. CCP will be responsible for the first $20 million in development costs prior to the initial Biologics License Application (BLA) filing with U.S. Food and Drug Administration (FDA) and manufacturing costs undertaken prior to commercial launch of FCX-007. If such spending exceeds $20 million , CCP will be responsible for 70% of the excess costs and Fibrocell will cover 30% of the remaining additional expenses. The Company will maintain responsibility for the development (including pre-launch manufacturing) of FCX-007 through initial BLA approval of FCX-007, and CCP will be responsible for all post-approval development and commercialization activities for FCX-007. The parties have agreed to negotiate the terms of a manufacturing and supply agreement that will set forth the terms under which the Company will supply CCP commercial quantities of FCX-007. A joint development committee consisting of representatives from the Company and CCP will oversee the development of FCX-007 pursuant to an agreed-upon development plan and budget.

At the closing of the CCP Agreement, the Company received an upfront payment of $7.5 million , and will receive an additional $2.5 million for the first patient enrolled in the Phase 3 clinical trial of FCX-007 and $30 million upon BLA approval of FCX-007 and FCX-007 commercial manufacturing readiness. The Company is also eligible to receive up to $75 million in sales milestones, consisting of $25 million upon the achievement of $250 million in cumulative FCX-007 net sales and an additional $50 million upon the achievement of $750 million in cumulative FCX-007 net sales. In addition, CCP will pay the Company a 30% share of the gross profits from FCX-007 sales. The Company will retain sole ownership of the Rare Pediatric Disease Priority Review Voucher, which may be granted upon BLA approval of FCX-007.

As part of the Company’s existing exclusive channel collaboration agreement with Intrexon Corporation (Intrexon), the Company will pay Intrexon 50% of all upfront, milestone and profit share payments from CCP. Payments to Intrexon do not include funds received by the Company from CCP in connection with the development and manufacturing costs or payments for supply of FCX-007.

Unless earlier terminated, the CCP Agreement will expire on the later of (a) expiration of the last to expire valid claim of any FCX-007 patent rights in the United States and (b) forty years from the date of initial BLA approval of FCX-007.

CCP has the right to terminate the CCP Agreement at will upon 180 days’ prior written notice. If CCP elects to terminate the CCP Agreement at will, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory pay to CCP an amount equal to five percent ( 5% ) of FCX-007 gross profit in

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Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 1. Business and Organization (continued)

respect of sales of FCX-007 in the territory by the Company, its affiliates or licensees in the initial indication and any additional indications developed or commercialized by the parties as of the effective date of termination.

CCP may also terminate the CCP Agreement at any time, upon 180 days’ prior written notice to the Company, in the event (i) CCP determines, in its reasonable discretion, that further development or commercialization of FCX-007 is not commercially viable or (ii) CCP determines that development or commercialization of FCX-007 must be terminated because of safety issues outside of CCP’s reasonable control.  If CCP elects to terminate the CCP Agreement due to either of the specified reasons set forth in the preceding sentence, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory pay to CCP an amount equal to five percent ( 5% ) of FCX-007 gross profit in respect of sales of FCX-007 in the territory by the Company, its affiliates or licensees in the initial indication and any additional indications developed or commercialized by the parties as of the effective date of termination. Either party may, subject to specified cure periods, terminate the CCP Agreement in the event of the other party’s uncured material breach, and either party may terminate the CCP Agreement under specified circumstances relating to the other party’s insolvency. The upfront payment and milestone payments are non-refundable; provided, however, that certain disputed payments may be refunded in accordance with the dispute resolutions procedures set forth in the CCP Agreement.

Based on the Company’s receipt of the upfront payment from CCP and reduction of expenses associated with the development of FCX-007, the Company believes its existing cash will be sufficient to fund operations into the third quarter of 2020.

The Company concluded its strategic alternative review process announced last year, as a result of the execution of the CCP Agreement with CCP.

Liquidity and Financial Condition

The Company expects to continue to incur losses and will require additional capital to advance its product candidates through development to commercialization. For the six-month period ended June 30, 2019 the Company recorded net income of approximately $8.1 million and used approximately $0.6 million in cash for operations. As of June 30, 2019 , the Company had cash and cash equivalents of approximately $13.7 million , working capital of approximately $ 17.8 million and an accumulated deficit of approximately $181.0 million .

The Company believes that its cash and cash equivalents at June 30, 2019 and amounts paid or payable to the Company under the CCP Agreement, including reimbursement of the FCX-007 development cost and the milestone payment for the first patient enrolled in the FCX-007 clinical trial will be sufficient to fund operations into the third quarter of 2020.

However, actual cash requirements could differ from management’s projections due to many factors, including the cost of clinical activities and outcomes related to our current and planned clinical trials, future correspondence with the FDA, enrollment rates for the Company’s clinical trials and unexpected capital expenditures. Accordingly, the foregoing conditions, taken together, continue to raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. 

To meet its capital needs, the Company intends to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition.



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Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 1. Business and Organization (continued)

On January 23, 2018, the Company received notice (the Notice) from the Nasdaq Stock Market LLC (Nasdaq) that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price of the Company’s common stock had been below $1.00 per share for 30 consecutive business days. On May 24, 2018, the Company implemented a one-for-five reverse split of the issued and outstanding shares of the Company’s common stock (the Reverse Stock Split), as authorized at the annual meeting of stockholders on May 23, 2018. The Reverse Stock Split became effective on May 24, 2018
at 5:00 pm and the Company’s common stock began trading on Nasdaq on a post-split basis at the open of business on May 25, 2018. As of a result of the Reverse Stock Split, every five shares of the Company’s issued and outstanding common stock were combined into one share of its common stock, except to the extent that the Reverse Stock Split resulted in any of the Company’s stockholders owning a fractional share, which was rounded up to the next highest whole share. In connection with the Reverse Stock Split, there was no change in the nominal par value per share of $0.001 . The Reverse Stock Split was effectuated in order to increase the per share trading price of the Company’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on Nasdaq. On June 11, 2018, the Company received written notice from Nasdaq notifying the Company that the closing bid price of the Company's common stock had been at $1.00 per share or greater for a
minimum of ten consecutive business days and accordingly, the Company had regained compliance with Nasdaq Listing Rule 5550(a)(2). All share and per share amounts of common stock, options and warrants in the accompanying financial statements
and related notes, have been restated for all periods to give retroactive effect to the Reverse Stock Split. Accordingly, the Condensed Consolidated Statement of Stockholders’ Equity reflects the impact of the Reverse Stock Split by reclassifying from
“Common Stock” to “Additional paid-in capital” an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split.

Nasdaq has the authority, pursuant to Nasdaq Listing Rule 5550(b)(1), to delist the Company’s common stock if its stockholders’ equity falls below $2.5 million. As of June 30, 2019, the Company’s stockholders’ equity was approximately $17.9 million . If the Company’s stockholders’ equity is hereafter reduced below $2.5 million as a result of operating losses or for other reasons, the Company will fail to meet Nasdaq’s stockholders’ equity requirement. If that occurs, or if the Company is unable to demonstrate to Nasdaq’s satisfaction that it will be able to sustain compliance with this requirement, Nasdaq may delist the Company’s common stock. In addition, even if the Company regains technical compliance with the stockholders’ equity requirement, it will have to continue to meet other objective and subjective listing requirements to continue to be listed on Nasdaq, including the requirement that the Company’s common stock continues to trade above $1.00.

The Company is actively monitoring its stockholders’ equity and will consider any and all options available to it to maintain compliance. There can be no assurance, however, that the Company will be able to maintain compliance and meet Nasdaq’s minimum stockholders’ equity requirements.

12

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 2. Basis of Presentation

General

The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnote disclosures required by GAAP for complete consolidated financial statements and certain information and footnote disclosures included in the Company’s annual consolidated financial statements and accompanying notes included in the 2018 Form 10-K, filed with the SEC, have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary to a fair statement of the results for the interim periods have been included. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP.

These financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and accompanying notes included in the 2018 Form 10-K. The Company’s significant accounting policies are described in the Notes to the Consolidated Financial Statements in the 2018 Form 10-K and updated, as necessary, in Note 3 in this Form 10-Q. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or full year.

All intercompany accounts and transactions have been eliminated in consolidation. The Company's international operations are immaterial, it has no unrealized gains or losses from the sale of investments and its minimal assets and liabilities are highly liquid and approximate fair value.
Note 3. Summary of Significant Accounting Policies

Revenue
For the three and six-month periods ended June 30, 2019 the Company earned 100% of its license and development service revenue from one collaboration partner.
In accordance with FASB’s ASC 606, Revenue from Contracts with Customers , or ASC 606, the Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To achieve this core principle, the Company applied the following five steps:
1) Identify the contract with the customer
A contract with a customer exists when (i) the Company enters into an enforceable contract with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the related payment terms, (ii) the contract has commercial substance, and (iii) the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. The Company applies judgment in determining the customer’s intent and ability to pay, which is based on a variety of factors including the customer’s historical payment experience, or in the case of a new customer, published credit and financial information pertaining to the customer.
2) Identify the performance obligations in the contract
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other available resources, and are distinct in the context of the contract, whereby the transfer of the good or service is separately identifiable from other promises in the contract. To the extent a contract includes multiple promised goods and services, the Company must apply judgment to determine whether the promised goods and services are capable of

13

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 3. Summary of Significant Accounting Policies (continued)

being distinct and are distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation.
3) Determine the transaction price
The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. Determining the transaction price requires significant judgment, which is discussed in further detail in Note 4.
4) Allocate the transaction price to performance obligations in the contract
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative stand-alone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative stand-alone selling prices. Determining the amount of the transaction price to allocate to each separate performance obligation requires significant judgment, which is discussed in further detail in Note 4.
5) Recognize revenue when or as the Company satisfies a performance obligation
The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either 1) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, 2) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or 3) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer. Examples of control are using the asset to produce goods or services, enhance the value of other assets, settle liabilities, and holding or selling the asset. ASC 606 requires the Company to select a single revenue recognition method for the performance obligation that faithfully depicts the Company’s performance in transferring control of the goods and services. The guidance allows entities to choose between two methods to measure progress toward complete satisfaction of a performance obligation:
 
1.
Output methods - recognize revenue on the basis of direct measurements of the value to the customer of the goods or services transferred to date relative to the remaining goods or services promised under the contract (e.g. surveys of performance completed to date, appraisals of results achieved, milestones reached, time elapsed, and units of produced or units delivered); and
 
 
2.
Input methods - recognize revenue on the basis of the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation.

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point

14

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 3. Summary of Significant Accounting Policies (continued)

in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company uses the most likely amount method for development and regulatory milestone payments. If it is probable that a significant cumulative revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Up-front Fees: Depending on the nature of the agreement, up-front payments and fees may be recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional.
Government Contracts, Grant Agreements and Incentive Programs
We recognize proceeds received from the FDA under our awarded grant, as other income, as it is not part of the Company’s ongoing operations to customers, and because the corresponding agreement contained no specified performance obligations other than to continue the study of RDEB through clinical trials and contains no obligations to deliver specified products or technology.
Income from the grant is recognized in the period during which the related qualifying expenses are incurred, provided that the conditions under which the grant was provided have been met. The grant contains specific quarterly financial reporting and periodic update reports on the progress of the clinical trials for FCX-007, that if not completed, would result in the forfeiture of grant monies available to be received under the awarded grant.
Grant income that is recognized upon incurring qualifying expenses in advance of receipt of grant funding, is recorded in our consolidated balance sheet as grant receivables.

Convertible Instruments

The Company has utilized various types of financing to fund its business needs, including convertible debt and convertible preferred stock with detachable warrants. The Company considers guidance within the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 470-20, Debt with Conversion and Other Options (ASC 470-20), ASC 480, Distinguishing Liabilities from Equity (ASC 480), and ASC 815, Derivatives and Hedging (ASC 815) when accounting for the issuance of its convertible securities. Additionally, the Company reviews the instruments to determine whether they are freestanding or contain an embedded derivative and, if so, whether they should be classified in permanent equity, mezzanine equity or as a liability at each reporting period until the amount is settled and reclassified into equity.

15

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 3. Summary of Significant Accounting Policies (continued)

When multiple instruments are issued in a single transaction, the Company allocates total proceeds from the transaction among the individual freestanding instruments identified. The allocation is made after identifying (1) all the freestanding instruments and (2) the subsequent measurement basis for those instruments. The subsequent measurement basis determines how the proceeds are allocated. Generally, proceeds are allocated based on one of the following methods:
Fair value method - The instrument being analyzed is allocated a portion of the proceeds equal to its fair value, with the remaining proceeds allocated to the other instruments as appropriate.
Relative fair value method - The instrument being analyzed is allocated a portion of the proceeds based on the proportion of its fair value to the sum of the fair values of all the instruments covered in the allocation.
Residual value method - The instrument being analyzed is allocated the remaining proceeds after an allocation is made to all other instruments covered in the allocation.

Generally, when there are multiple instruments issued in a single transaction that have different subsequent measurement bases, the proceeds from the transaction are first allocated to the instrument that is subsequently measured at fair value (i.e. - instruments accounted for as a derivative liability) at its issuance date fair value, with the residual proceeds allocated to the instrument not subsequently measured at fair value. In the event both instruments in the transaction are not subsequently measured at fair value (i.e. equity-classified instruments), the proceeds from the transaction are allocated to the freestanding instruments based on their respective fair values, using the relative fair value method.

After the proceeds are allocated to the freestanding instruments, resulting in an initial discount on the host contract, those instruments are further evaluated for embedded features (i.e. conversion options) that require bifurcation and separate accounting as a derivative financial instrument pursuant to ASC 815. Embedded derivatives are initially and subsequently measured at fair value. Under ASC 815, a portion of the proceeds received upon the issuance of the hybrid contract is allocated to the fair value of the derivative. See Note 6 for additional discussion on the identified embedded derivatives associated with the Company’s convertible notes.

The Company accounts for convertible instruments in which it is determined that the embedded conversion options should not be bifurcated from their host instruments, in accordance with ASC 470-20. Under ASC 470-20, the Company records, when necessary, discounts to convertible notes or convertible preferred stock for the intrinsic value of conversion options embedded in the convertible instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the convertible instrument, unless limited by the proceeds allocated to such instrument. See Note 6 and Note 12 for additional discussion on the identified embedded features (conversion options) associated with the Company’s convertible notes and convertible preferred stock and resulting beneficial conversion features recorded.

The Company allocates issuance costs between the individual freestanding instruments identified on the same basis as proceeds were allocated. Issuance costs associated with the issuance of stock or equity contracts (i.e. equity-classified warrants and convertible preferred stock) are recorded as a charge against the gross proceeds of the offering. Issuance costs associated with the issuance of debt (i.e. convertible debt) is recorded as a direct reduction of the carrying amount of the debt liability, however, if debt issuance costs exceed the carrying amount of the debt, issuance costs are recorded to additional paid-in capital as a reduction of the beneficial conversion feature. Any issuance costs associated with the issuance of liability-classified warrants are expensed as incurred.

Income Taxes
    
In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis.  For the three months ended March 31, 2019 and 2018, the Company did no t record a tax expense or benefit. The effective tax rate for the three months ended March 31, 2019 and 2018 was 0% . The effective tax rate for the three months ended March 31, 2019 and 2018 differs from the statutory tax rate due to expected current year and historical losses.  For the six months ended June 30, 2019 and 2018, the Company recorded a tax expense of $0.6 million and $0 , respectively. The effective tax rate for the six months ended June 30, 2019 and 2018 was 7.23%

16

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 3. Summary of Significant Accounting Policies (continued)

and 0% , respectively. The effective tax rate for the six months ended June 30, 2019 differs from the statutory rate primarily due to Pennsylvania state taxes that result from Pennsylvania’s limitation on the use of net operating losses allowed to be utilized against Pennsylvania taxable income generated as a result of the revenue recorded from the CCP Agreement. The Company does not have a net deferred tax asset because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is more likely than not, that the Company will be unable to realize these future tax benefits. As of June 30, 2019, the Company had no uncertain tax positions.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company adopts as of the specified date. Unless otherwise noted, management does not believe that any recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future consolidated financial statements.    
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), to increase transparency and comparability among organizations by recognizing lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Topic 842 affects any entity that enters into a lease, with some specified scope exceptions. For public business entities, the amendments in Topic 842 are effective for annual periods beginning after December 15, 2018, and interim periods within those annual periods. The Company adopted Topic 842 in the annual period beginning January 1, 2019. The Company applied the modified retrospective transition method and elected the transition option to use the effective date of January 1, 2019 as the date of initial application. The Company did not adjust its comparative period financial statements for effects of Topic 842.

The Company has elected the package of practical expedients permitted under the transition guidance within the new standard as listed below:

a. An entity need not reassess whether any expired or existing contracts are or contain leases;

b. An entity need not reassess the lease classification for any expired or existing leases (for example, all existing leases that were classified as operating leases in accordance with Topic 840 will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with Topic 840 will be classified as finance leases);

c. An entity need not reassess initial direct costs for any existing leases;

In addition the Company elected a practical expedient, which must be applied consistently by an entity to all of its leases (including those for which the entity is a lessee or a lessor) to use hindsight in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the entity’s right-of-use assets.
    
The adoption of the new standard resulted in recording right of use assets-operating lease, of approximately $4.5 million and lease liabilities-operating lease, of approximately  $5.3 million  as of January 1, 2019. See Note 5 for additional information related to leases.




17

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 3. Summary of Significant Accounting Policies (continued)

The details of this adjustment are summarized below:
 
Balance at December 31, 2018
Adjustments due to ASC 842
Balance at January 1, 2019
 
 
 
 
Assets
 
 
 
Right of use asset - operating lease
$

 
$
4,452

 
$
4,452

 
 
 
 
 
Liabilities
 
 
 
Lease liability - current - operating lease
 
 
111
 
 
111
 
 
Deferred rent - current
150
 
 
(150
)
 
 
 
 
 
 
 
Lease liability - long term - operating lease
 
 
5,156
 
 
5,156
 
 
Deferred rent - long term
665
 
 
(665
)
 
 
 
 
 
 
 


    
    

















    


18

Table of Contents
Fibrocell Science, Inc.
Notes to Consolidated Financial Statements
(unaudited)

Note 4. Revenue from Contracts with Customers
CCP Co-development and License Agreement
On April 12, 2019, the Company entered into the CCP Agreement with CCP with respect to the development and commercialization of the Company’s lead gene therapy candidate, FCX-007, for the treatment of RDEB.

Under the terms of the CCP Agreement, CCP received an exclusive license to commercialize FCX-007 in the United States. CCP will be responsible for the first $20 million in development costs prior to the initial BLA filing with the FDA and manufacturing costs undertaken prior to commercial launch of FCX-007. If such spending exceeds $20 million , CCP will be responsible for 70% of the excess costs and the Company will be responsible for 30% of the remaining additional expenses. The Company will maintain responsibility for the development (including pre-launch manufacturing) of FCX-007 through initial BLA approval of FCX-007, and CCP will be responsible for all post-approval development and commercialization activities for FCX-007. The parties have agreed to negotiate the terms of a manufacturing and supply agreement that will set forth the terms under which the Company will supply CCP commercial quantities of FCX-007. A joint development committee consisting of representatives from the Company and CCP will oversee the development of FCX-007 pursuant to an agreed-upon development plan and budget.

The Company received an upfront payment of $7.5 million , and will receive an additional $2.5 million for the first patient enrolled in the Phase 3 clinical trial and $30 million upon BLA approval and commercial manufacturing readiness. The Company is also eligible to receive up to $75 million in sales milestones, consisting of $25 million upon the achievement of $250 million in cumulative FCX-007 net sales and an additional $50 million upon the achievement of $750 million in cumulative FCX-007 net sales. In addition, CCP will pay the Company a 30% share of the gross profits from FCX-007 sales.

As part of the Company’s existing exclusive channel collaboration agreement with Intrexon, the Company will pay Intrexon 50% of all upfront, milestone and profit share payments from CCP. Payments to Intrexon do not include funds received by the Company from CCP in connection with the development and manufacturing costs or payments for supply of FCX-007.

Unless earlier terminated, the CCP Agreement will expire on the later of (a) expiration of the last-to-expire valid claim of any FCX-007 patent rights in the United States and (b) forty years from the date of initial BLA approval of FCX-007.

CCP has the right to terminate the CCP Agreement at will upon 180 days’ prior written notice. If CCP elects to terminate the CCP Agreement at will, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory pay to CCP an amount equal to five percent ( 5% ) of FCX-007 gross profit in respect of sales of FCX-007 in the territory by the Company, its affiliates or licensees in the Initial Indication and any additional indications developed or commercialized by the parties as of the effective date of termination.

CCP may also terminate the CCP Agreement at any time, upon 180 days’ prior written notice to the Company, in the event (i) CCP determines, in its reasonable discretion, that further development or commercialization of FCX-007 is not commercially viable or (ii) CCP determines that development or commercialization of FCX-007 must be terminated because of safety issues outside of CCP’s reasonable control. If CCP elects to terminate the CCP Agreement due to either of the specified reasons set forth in the preceding sentence, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory pay to CCP an amount equal to five percent ( 5% ) of FCX-007 gross profit in respect of sales of FCX-007 in the territory by the Company, its affiliates or licensees in the initial indication and any additional indications developed or commercialized by the parties as of the effective date of termination. Either party may, subject to specified cure periods, terminate the CCP Agreement in the event of the other party’s uncured material breach, and either party may terminate the CCP Agreement under specified circumstances relating to the other party’s insolvency. The upfront payment and milestone payments are non-refundable; provided, however, that certain disputed payments may be refunded in accordance with the dispute resolutions procedures set forth in the CCP Agreement.



19

Table of Contents
Fibrocell Science, Inc.
Notes to Consolidated Financial Statements
(unaudited)

Note 4. Revenue from Contracts with Customers (continued)

The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, CCP, is a customer. The Company identified the following distinct performance obligations under the contract: (1) an exclusive license to the Company’s know-how and patent rights to manufacture and market FCX-007 (IP); and (2) the provision of development services.  
The Company determined that the initial upfront payment of $7.5 million and approximately $21.7 million of development services, totaling approximately $29.2 million , constituted all of the consideration to be included in the initial transaction price and to be allocated to the performance obligations based on their relative stand-alone selling prices. The initial transaction price also includes the $2.5 million milestone which the Company will receive with the first patient’s admission into the Phase 3 clinical trial. This milestone has been fully attributed to the development services, increasing the total transaction price at inception to approximately $31.7 million .
Revenue attributable to the sale of a right to use the exclusive license for IP was recognized at a point in time when the license transferred to CCP. The Company assessed the relative stand-alone selling price of each performance obligation, utilizing a discounted cash flow model for the license and a cost plus margin model for the research and development services, then allocated the transaction price to each performance obligation based upon their relative stand-alone selling prices. The relative stand-alone selling prices were approximately a 72% / 28% split between the license and research and development services, resulting in approximately $21.0 million , being assigned to the license and approximately $8.2 million being assigned to the research and development services. Therefore the $21.0 million assigned to the license was recognized as revenue in both the three and six months ended June 30, 2019. A contract asset of $13.5 million has been recorded for the excess of revenue recognized over the $7.5 million upfront payment received.
The remaining revenue of $10.7 million related to the development activities will be recognized over time as those services are delivered based on the cost-to-cost input method. The Company believes the cost-to-cost method provides the most faithful depiction of value transferred to the customer. At June 30, 2019, $9.9 million of this revenue remains unrecognized and is expected be recognized through the first half of 2021 as follows (in millions).

Time Period
Amount
Remainder of 2019
4.7
2020
4.3
2021
0.9
Total
9.9
    
The $30 million milestone for BLA approval has been excluded from the initial transaction price, as the Company could not conclude that it was probable a significant reversal of cumulative revenue would not occur. Event driven milestones are a form of variable consideration as the payments are variable based on the occurrence of future events. As part of its estimation of the amount, the Company considered numerous factors, including that the receipt of the milestones is outside of its control and contingent upon success in future clinical trials and the licensee’s efforts.
Milestones based on sales levels, will be treated as sales/use based royalties related to the license and will therefore, be earned as the sales thresholds are met and are not considered part of the transaction price..




20

Table of Contents
Fibrocell Science, Inc.
Notes to Consolidated Financial Statements
(unaudited)

Note 4. Revenue from Contracts with Customers (continued)
Disaggregation of Revenue
The following table presents revenue (in thousands) for the three and six-month periods ended June 30, 2019 disaggregated by revenue type.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Three Months Ended June 30, 2019
 
 
Six Months Ended June 30, 2019
 
 
Revenue Type
 
 
 
 
 
 
 
 
 
License revenue
 
$
20,979

 
 
$
20,979

 
 
Collaboration revenue
 
 
813

 
 
 
813

 
 
 
 
$
21,792

 
 
$
21,792

 
 
 
 
 
 

 
 
 
 

 
 

Contract Balances
Contract assets primarily relate to our rights to consideration for the license delivered but not billed at the reporting date. The contract assets are transferred to the receivables when the rights become unconditional. At June 30, 2019 the Company had $12.7 million in contract assets, with $8.4 million classified in current assets and $4.3 classified in long-term assets. The Company had no asset impairment charges related to contract assets in the period. The following table provides information about contract assets from contracts with customers (in thousands):

Year ended December 31, 2018
 
Balance at beginning of period
 
 
Additions
 
 
Deductions
 
 
Balance at June 30, 2019
 
Contract assets:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Unbilled receivables from collaboration partners
 
$

 
 
$
13,479

 
 
$
(761
)
 
 
$
12,718

 

During the three and six-month periods ended June 30, 2019, the Company did no t recognize any revenue from amounts included in the contract asset balances from performance obligations satisfied in previous periods. The Company has no costs to obtain or fulfill contracts that would qualify for capitalization.   Amounts billed to CCP under this arrangement are payable to the Company within 60 days.

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Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 5. Leases

The Company has an operating lease for an office, manufacturing and research building, located at 405 Eagleview Boulevard, Exton, Pennsylvania, which consists of approximately 86,500 square feet of space.

The Company entered into this operating lease in April 2011. The lease agreement has a remaining lease term of 3 years, 9 months , and expires in March 2023. The lease also contains an additional five year option for the Company to extend the lease at a fair market value rate, which the Company expects to exercise. The lease term, is the period of the lease not cancellable by the Company, together with periods covered by: (i) renewal options the Company is reasonable certain to exercise, (ii) termination options the Company is reasonable certain not to exercise and (iii) renewal or termination options that are controlled by the lessor.

The Company has elected the practical expedient not to separate lease components from non-lease components for all its underlying assets. If the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rate as the discount rate. The Company uses its best judgment when determining the incremental borrowing rate, which is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term to the lease payments in a similar currency.

The operating lease cost for the three and six months ended June 30, 2019 was approximately $0.4 million and $0.7 million , respectively. For the three and six months ended June 30, 2019, approximately $0.3 million and $0.6 million , respectively was charged to selling, general and administrative expenses and approximately $0.1 million for each of the periods was charged to research and development expenses, with a remaining lease term of 8 years, 9 months , inclusive of the 5 year renewal option the Company expects to exercise.

Cash payments made in the six months ended June 30, 2019 under the operating lease was approximately $0.7 million .

The rate implicit in the leases was not readily determinable, and the Company computed its incremental borrowing rate using the following methodology:

1.) Development of an estimate of the term structure of the USD senior unsecured cost of debt for the Company as of the analysis date, which entailed the selection of a benchmark yield curve that approximates the credit risk of the Company on a senior unsecured basis. The B- benchmark yield curve was selected as the curve corresponding to the lowest available credit rating.
 
2.) Development of estimates of yield curves as of the analysis date for debt seniorities ranging from senior secured to senior unsecured cost of debt for the Company utilizing a recovery rates model that estimates yields based on expected recoveries on defaulted debt instruments across the Company’s capital structure.

Based upon the methods used above, the Company’s incremental borrowing rate was determined to be 25.49% , for its office lease, which is the only lease the Company has converting to the new standard.

    














22

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 5. Leases (continued)

The following table provides a breakdown of our lease balances within our condensed consolidated balance sheet as of June 30, 2019:

Right of use asset - operating lease
 
$
4,421

 
 
 
Lease liabilities - current - operating lease
 
186

 
 
 
Lease liabilities - long term - operating lease
 
5,057

 
 
 
Total lease liabilities - operating lease
 
$
5,243


    
Other information related to our lease is as follows:

 
 
June 30,
2019
 
 
 
Remaining lease term- operating lease, in years
 
8.75 years

 
 
 
Discount rate - operating lease
 
25.49
%

    
Future minimum lease payments under our non-cancellable operating lease as of June 30, 2019 were as follows:

Year ending December 31,
2019
$
735

 
2020
1,471

 
2021
1,471

 
2022
1,471

 
2023
1,471

 
2024 and thereafter
6,248

 
 
 
 
Total
12,867

 
 
 
 
Less: imputed interest
(7,624
)
 
 
 
 
Current and long-term operating lease liability
$
5,243














23

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 5. Leases (continued)

Future minimum lease payments under non-cancellable operating leases prior to adoption of ASC 842, Leases, as of December 31, 2018 were as follows:

Year ending December 31,
2019
$
1,416

 
2020
1,471

 
2021
1,471

 
2022
1,471

 
2023
368

 
 
 
 
Total
6,197




24

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 6. Convertible Notes

2016 Private Placement

In September 2016, the Company issued an aggregate of $18,087,500 in principal of convertible promissory notes (each, a Note and collectively, the Notes) and accompanying warrants to purchase an aggregate of 1,205,840 shares of the Company’s common stock (each a Warrant and collectively, the Warrants) in a private placement to institutional and accredited investors (each an Investor and collectively, the Investors).     

The Notes bear interest at four percent ( 4% ) per annum. Interest is earned daily and compounded quarterly and, at the election of the Company at the beginning of each quarter, shall accrue or be paid in cash. If the Company elects to have interest accrue, such interest will not be added to the principal amount of the Notes but such interest shall be subject to additional interest at the rate of four percent ( 4% ) per annum, compounded quarterly, and shall be due and payable upon the earliest of the conversion of the Notes, exercise of the Put Right, exercise of the Prepayment Right or the Maturity Date (in each case, as defined below). Additionally, if the Company elects for interest to accrue, then (i) the Company may elect to repay any such accrued and unpaid interest in cash at any time and from time to time and (ii) each Investor may elect to have the Company repay any such accrued and unpaid interest by delivering such number of shares of the Company’s common stock equal to (x) the amount of the accrued and unpaid interest to be repaid, divided by (y) the greater of (i) the last closing bid price of a share of the Company’s common stock as reported on Nasdaq on the date of such election plus $0.12625 , and (ii) the Conversion Price (as defined below). As of June 30, 2019 and for each prior quarterly period since issuance, the Company has elected to accrue interest. At June 30, 2019 the outstanding notes have a principal balance due of approximately $18 million and related accrued interest of approximately $2.1 million .

All unpaid principal of each Investor’s Note is convertible, at any time and from time to time, at the option of such Investor into shares of the Company’s common stock at each such Investors’ applicable conversion price (as subject to adjustment, the Conversion Price) which range from $17.04375 to $18.39375 per share.

The Notes have a maturity date of the earlier of (i) September 7, 2026 and (ii) one-hundred and eighty ( 180 ) days after the date on which the Company’s product candidate, FCX-007, is approved by the FDA for the treatment of RDEB (the Maturity Date). Each Investor has the right to require the Company to repay all or any portion of the unpaid principal and accrued and unpaid interest from time to time on or after September 7, 2021 (such right, a Put Right). Such Put Right must be exercised by such Investor by delivering written notice to the Company no later than one-hundred and eighty ( 180 ) days prior to such exercise date of such Put Right. In addition, upon consummation of a specified change of control transaction, each Investor may elect to accelerate the repayment of all unpaid principal and accrued interest under such Investor’s Note. If an Investor does not elect to have the Company prepay its Note upon such change of control transaction, then the Company may prepay the Notes, in an amount equal to one hundred one percent ( 101% ) of the outstanding principal due under the Notes (together with accrued and unpaid interest due thereon) (the Prepayment Right). Additionally, upon the occurrence of certain Events of Default, as defined in the Notes, each Investor may elect to accelerate the repayment of all unpaid principal and accrued interest under each Note and the Notes provide for automatic redemption upon the occurrence of certain bankruptcy related Events of Default, as defined in the Notes.

During the three and six months ending June 30, 2019, there were no conversions of the Notes into shares of the Company’s common stock.

Accounting for Convertible Notes and Embedded Derivatives

The Company accounts for debt as liabilities measured at amortized cost and amortizes the resulting debt discount from allocation of proceeds to interest expense using the effective interest method over the expected term of the Notes pursuant to ASC 835, Interest (ASC 835).
    
See Note 3 for discussion of the Company’s policies for accounting for convertible instruments (i.e. convertible debt) with detachable liability-classified warrants. In connection with the issuance of the Notes and Warrants, the Company recorded a debt discount of approximately $18.1 million based on an allocation of proceeds to the Warrants of approximately $9.6

25

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 6. Convertible Notes (continued)


million , an allocation to bifurcated derivatives (which consist of a contingent put option upon a change of control or acceleration upon event of default (the Contingent Put Option) and a contingent call option upon a change of control (the Contingent Call Option) included in the Notes of approximately $1.3 million , and a beneficial conversion feature of approximately $7.2 million , before issuance costs, based on the difference between the fair value of the underlying common stock at the commitment date of each Note transaction and the effective conversion price of the Notes, as limited by the proceeds allocated to the Notes.
    
Convertible promissory notes outstanding were as follows:
($ in thousands)
June 30,
2019
 
December 31,
2018
Convertible promissory notes
$
18,003

 
$
18,003

Debt discount - warrants
(9,598
)
 
(9,598
)
Debt discount - compound bifurcated derivatives
(1,267
)
 
(1,267
)
Debt discount - beneficial conversion feature
(7,138
)
 
(7,138
)
Convertible promissory notes, net
$

 
$


The debt discount and issuance costs are amortized using the effective interest method over five years , the expected term of the Notes, and is included in interest expense in the Condensed Consolidated Statements of Operations. Amortization for the six months ended June 30, 2019 and June 30, 2018, including the amortization of the issuance costs, was $0 for both periods. Based on an effective yield of approximately 1157% resulting from the Notes being initially recorded at a full discount, the Company will not recognize any material amounts of amortization until years 2020 and 2021.

Assumptions Used in Determining Fair Value of Compound Bifurcated Derivative

The Company utilizes a binomial lattice model to value its bifurcated derivatives included in the Notes. ASC 815 does not permit an issuer to account separately for individual derivative terms and features embedded in hybrid financial instruments that require bifurcation and liability classification as derivative financial instruments. Rather, such terms and features must be combined together and fair valued as a single, compound embedded derivative. The Company selected a binomial lattice model to value the compound embedded derivative because it believes this technique is reflective of all significant assumptions that market participants would likely consider in negotiating the transfer of the Notes. Such assumptions include, among other inputs:

Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the volume-weighted average expected remaining life of the Notes.

Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve in effect at the valuation date commensurate with the expected remaining life assumption.

Expected remaining life. The expected life of the Notes is assumed to be equivalent to their remaining contractual term.

Dividend rate. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero .

Scenarios. The probability of complex features of the compound bifurcated derivative being triggered is subjective (no observable inputs or available market data) and based on internal and external information known to management at the valuation date. Such assumptions include, among other inputs, probabilities related to a change of control and when it might occur as well as probabilities related to a default under the provisions of the Notes and when it might occur.

Changes to the key assumptions or to the scenarios used in the valuation model, including the probability of key events, such as a change of control transaction, and the credit spread could have a material impact to the overall valuation of the

26

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 6. Convertible Notes (continued)


compound bifurcated derivative liability. A 5% change to the probability of a change of control event occurring in 2019 and 2020 would impact the derivative fair value by approximately $0.3 million and $0.1 million , respectively. A 5% change in the estimated credit spread would impact the derivative fair value by approximately $0.4 million . The sensitivity examples provided are included for illustrative purposes only and do not reflect the changes in these assumptions used by the Company. Changes in excess of those illustrated may occur in any period.

The estimated fair value of the compound bifurcated derivative is determined to represent a Level 3 instrument. Significant inputs and assumptions used in the binomial lattice model for the derivative liability are as follows:
($ in thousands except per share data)
June 30, 2019
 
December 31, 2018
Calculated aggregate value
$
2,557

 
$
1,474

Closing price per share of common stock
$
1.90

 
$
1.50

Contractual remaining term
7 years, 2 months

 
7 years, 8 months

Contractual interest rate
4.0
%
 
4.0
%
Volume-weighted average conversion rate
$
17.04667

 
$
17.04667

Risk-free interest rate (term structure)
1.71% - 2.18%

 
2.44% - 2.69%

Dividend yield

 

Credit Rating
CC

 
CC

Credit Spread
28.01
%
 
31.77
%
Volatility
89.2
%
 
87.5
%

The foregoing compound bifurcated derivative was recorded at its estimated fair value at the date of issuance, with subsequent changes in estimated fair value recorded in derivative revaluation income (expense) in the Company’s Condensed Consolidated Statements of Operations.  The change in estimated fair value of the Company's derivative liability for the six months ended June 30, 2019 and June 30, 2018 resulted in non-cash income (expense) of approximately $(1.1) million and approximately $0.2 million , respectively.
Note 7. Warrants

The Company accounts for common stock warrants as either equity instruments, derivative liabilities or liabilities depending on the specific terms of the warrant agreement. See Note 3 for further details on accounting policies related to the Company’s convertible instruments, including common stock warrants.

In connection with various financing transactions, the Company has issued warrants to purchase the Company’s common stock. In July 2018, in connection with a private placement (the July 2018 Private Placement), the Company issued unregistered warrants to purchase 958,152 shares of its common stock. Each common stock purchase warrant has an exercise price of $2.70 per share, was exercisable upon the date of issuance and expires five and one-half years from the date of the issuance. In addition, the Company also issued unregistered warrants to purchase up to an aggregate of 103,186 shares of its common stock to the designees of H.C. Wainwright & Co., LLC (Wainwright), as partial compensation for placement agent services by Wainwright in connection with the Company’s registered direct public offering in July 2018 (the July 2018 Registered Direct Public Offering), and the July 2018 Private Placement. Such unregistered warrants have an initial exercise price of $3.464 per share are immediately exercisable and expire on July 3, 2023.

In May 2018 in connection with a private placement (the May 2018 Private Placement), the Company issued unregistered warrants to purchase 1,528,668 shares of its common stock. Each common stock purchase warrant has an exercise price of $2.86 per share, was exercisable upon the date of the issuance and expires five and one-half years from the date of the issuance. The Company also issued unregistered warrants to purchase up to an aggregate of 142,676 shares of its common stock to the designees of Wainwright, as partial compensation for placement agent services by Wainwright in connection with the Company’s registered direct public offering in May 2018 (the May 2018 Registered Direct Public Offering), and the May

27

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 7. Warrants (continued)

2018 Private Placement. Such unregistered warrants have an initial exercise price of $3.679 per share are immediately exercisable and expire on May 30, 2023.

On July 27, 2018, the Company filed a registration statement on Form S-1 (the Resale Registration Statement) registering the resale of shares of the Company’s common stock underlying warrants issued in the May 2018 Private Placement and the July 2018 Private Placement. The Resale Registration Statement was declared effective by the SEC on August 8, 2018.

In December 2017, the Company issued (i) pre-funded warrants to purchase an aggregate of 1,184,442 shares of the Company’s common stock and (ii) common stock purchase warrants to purchase up to an aggregate of 2,809,404 shares of the Company’s common stock including warrants to purchase up to 82,118 shares, issued pursuant to the partial exercise of the underwriters option to purchase additional common stock purchase warrants (the December 2017 Offering). Each pre-funded warrant was sold together with a common stock purchase warrant to purchase one share of the Company’s common stock at a combined effective price of $3.85 per share and accompanying warrant. Each common stock purchase warrant has an exercise price of $3.85 per share, was exercisable upon the date of issuance and expires five years from the date of issuance. As additional compensation, the Company issued warrants to the underwriter to purchase 87,274 shares of the Company’s common stock. Each such warrant has an exercise price of $4.8125 per share, and was exercisable as of the date of the underwriting agreement, and will expire five years after the date of the underwriting agreement.

In March 2017, the Company issued warrants to purchase 687,468 shares of its common stock in connection with the Company’s public offering of convertible preferred stock and warrants (each a Series A Warrant and collectively, the Series A Warrants), more fully described in Note 12. Each Series A Warrant has an exercise price of $12.69 , is exercisable six months after the date of issuance and will expire five years from the date of issuance.

The Company’s outstanding warrants consist of both liability-classified warrants and equity-classified warrants. The following table summarizes outstanding warrants to purchase the Company’s common stock:
 
Number of warrants
 
 
 
 
 
June 30, 2019
 
December 31, 2018
 
Exercise
Price
 
Expiration
Dates
Liability-classified Warrants
 
 
 
 
 
 
 
Issued with September 2016 Convertible Notes
1,205,840

 
1,205,840

 
$
22.50

 
Sept 2021
Total liability-classified warrants
1,205,840

 
1,205,840

 
 
 
 
 
 
 
 
 
 
 
 
Equity-classified Warrants
 
 
 
 
 
 
 
   Issued in 2017 Series A Preferred Stock Offering
687,468

 
687,468

 
$
12.69

 
Mar 2022
Issued in December 2017 Offering - common warrants
2,679,702

 
2,679,702

 
$
3.85

 
Dec 2022
Issued in December 2017 Offering - underwriter warrants
87,274

 
87,274

 
$
4.8125

 
Dec 2022
Issued in May 2018 Private Placement - common warrants
1,528,668

 
1,528,668

 
$
2.86

 
Nov 2023
Issued in May 2018 - underwriter warrants
142,676

 
142,676

 
$
3.679

 
May 2023
Issued in July 2018 Private Placement - common warrants
958,152

 
958,152

 
$
2.70

 
Jan 2024
Issued in July 2018 - underwriter warrants
103,186

 
103,186

 
$
3.464

 
Jul 2023
Total equity-classified warrants
6,187,126

 
6,187,126

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total outstanding warrants
7,392,966

 
7,392,966

 
 

 
 



28

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 7. Warrants (continued)

The table below is a summary of the Company’s warrant activity during the six months ended June 30, 2019:
 
Number of warrants
 
Weighted-
average
exercise
price
 
Liability-classified
Equity-classified
Total
 
Outstanding at December 31, 2018
1,205,840

6,187,126

7,392,966

 
$
7.36

Granted



 

Exercised



 

Expired



 

Outstanding at June 30, 2019
1,205,840

6,187,126

7,392,966

 
$
7.36


Accounting for Liability-Classified Warrants

The Company’s liability-classified warrants were recorded as liabilities at their estimated fair value at the date of issuance, with the subsequent changes in estimated fair value recorded in warrant revaluation income in the Company’s Condensed Consolidated Statements of Operations in each subsequent period. The change in the estimated fair value of the warrant liability for the six months ended June 30, 2019 and June 30, 2018, resulted in non-cash income of approximately $0.01 million and $0.3 million , respectively.

Additionally, the liability-classified warrants are classified as either current or non-current on the Company’s Condensed Consolidated Balance Sheets based on their contractual expiration date. The Company utilizes a Monte Carlo simulation valuation method to value its liability-classified warrants.

Assumptions Used In Determining Fair Value of Liability-Classified Warrants

The estimated fair value of warrants is determined using Level 2 and Level 3 inputs (as described below).  Inherent in the Monte Carlo simulation valuation method are the following assumptions:

Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the volume-weighted average expected remaining life of the warrants.

Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve in effect at the valuation date commensurate with the expected remaining life assumption.

Expected remaining life. The expected life of the warrants is assumed to be equivalent to their remaining contractual term.

Dividend rate. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero .

Scenarios.  The probability of complex features of the warrants being triggered is subjective (no observable inputs or available market data) and based on internal and external information known to management at the valuation date. Such assumptions include, among other inputs, probabilities related to a change of control and when it might occur as well as probabilities related to a default under the provisions of the Notes and when it might occur.

Changes to the key assumptions or to the scenarios used in the valuation model, including the probability of key events, such as a change of control transaction, could have a material impact to the overall valuation of the warrant liability.

    



29

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 7. Warrants (continued)

    
The following table summarizes the calculated aggregate fair values of the liability classified warrants, along with the inputs and assumptions utilized in each calculation:
 
 
 
 
($ in thousands except per share data)
June 30, 2019
 
December 31, 2018
Calculated aggregate value
$
144

 
$
152

Weighted average exercise price per share
$
22.50

 
$
22.50

Closing price per share of common stock
$
1.90

 
$
1.50

Volatility
92.8
%
 
94.1
%
Weighted average remaining expected life
2 years, 3 months

 
2 years, 8 months

Risk-free interest rate
1.74
%
 
2.45
%
Dividend yield

 




30

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 8. Fair Value Measurements

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The Company follows the guidance in ASC 820, Fair Value Measurement , to account for financial assets and liabilities measured on a recurring basis. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The guidance requires fair value measurements be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There were no transfers between Level 1, 2 and 3 during the six months ended June 30, 2019.

The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2019 and December 31, 2018:
 
June 30, 2019
($ in thousands) 
Level 1
 
Level 2
 
Level 3
 
Total
Assets:
 

 
 

 
 

 
 

Cash and cash equivalents, money market funds with less than 90 days maturity
$
12,369

 
$

 
$

 
$
12,369

Total Assets
$
12,369

 
$

 
$

 
$
12,369

Liabilities:
 

 
 

 
 

 
 

Warrant liability
$

 
$

 
$
144

 
$
144

Derivative liability

 

 
2,557

 
2,557

Total Liabilities
$

 
$

 
$
2,701

 
$
2,701

 

 
December 31, 2018
($ in thousands) 
Level 1
 
Level 2
 
Level 3
 
Total
Assets:
 

 
 

 
 

 
 

Cash and cash equivalents, money market funds with less than 90 days maturity
$
12,290

 
$

 
$

 
$
12,290

Total Assets
$
12,290

 
$

 
$

 
$
12,290

Liabilities:
 

 
 

 
 

 
 

Warrant liability
$

 
$

 
$
152

 
$
152

Derivative liability

 

 
1,474

 
1,474

Total Liabilities
$

 
$

 
$
1,626

 
$
1,626


31

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 8. Fair Value Measurements (continued)


Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis

Common Stock Warrants - Warrant Liability
    
The reconciliation of the Company’s warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows:
 
Warrant
($ in thousands)
Liability
Balance at December 31, 2018
$
152

Change in fair value of warrant liability
(8
)
Balance at June 30, 2019
$
144


The fair value of the warrant liability is based on Level 3 inputs. For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value. See Note 7 for further discussion of the warrant liability.

Bifurcated Compound Derivative - Derivative Liability

The reconciliation of the derivative liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows:
 
Derivative
($ in thousands)
Liability
Balance at December 31, 2018
$
1,474

Change in fair value of derivative liability
1,083

Balance at June 30, 2019
$
2,557


The fair value of the derivative liability is based on Level 3 inputs. For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value. See Note 6 for further discussion of the derivative liability.

Effect of the Company’s Stock Price and Volatility Assumptions on the Calculation of Fair Value of Financial Instruments Measured on a Recurring Basis

Common Stock Warrants - Warrant Liability

The fair value of the Company's warrant liability is based on Level 3 inputs. As discussed in Note 6, the Company uses a Monte Carlo simulation valuation method to value its liability-classified warrants. The determination of fair value as of the reporting date is affected by the Company's stock price as well as assumptions regarding a number of subjective variables that do not have observable inputs or available market data to support the fair value. These variables include, but are not limited to, expected stock price volatility over the term of the warrants and the risk-free interest rate. The primary factors affecting the fair value of the warrant liability are the Company's stock price and volatility as well as certain assumptions by the Company as to the likelihood of provisions to the underlying warrant agreements being triggered. The methods described above and in Note 6 may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation method is appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date.




32

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 8. Fair Value Measurements (continued)


Bifurcated Compound Derivative - Derivative Liability

The fair value of the derivative liability is based on Level 3 inputs. As discussed in Note 6, the Company uses a binomial lattice model to value the compound embedded derivative bifurcated from the Notes. The determination of fair value as of the reporting date is affected by the Company’s stock price as well as assumptions regarding a number of subjective variables that do not have observable inputs or available market data to support the fair value. These variables include, but are not limited to, expected stock price volatility, changes in interest rates, assumptions regarding the adjusted conversion prices in the Notes, and early redemption or conversion of the Notes. The methods described above and in Note 6 may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation method is appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date.

Fair Value of Certain Financial Assets and Liabilities

The Company believes that the fair values of its current assets and liabilities approximate their reported carrying amounts. The fair value of the long-term convertible promissory notes with embedded derivatives was approximately $16.9 million at June 30, 2019, based on Level 3 inputs, compared to a carrying value of $0 , as a result of unamortized debt discounts.

33

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 9. Stock-Based Compensation

2019 Equity Incentive Plan

The Company’s Board of Directors (the Board) adopted the 2019 Equity Incentive Plan (the Plan), which was subsequently approved by the Company’s stockholders, effective June 12, 2019.  The Plan superseded and replaced the Company’s 2009 Equity Incentive Plan in its entirety. The Plan is intended to further align the interests of the Company and its stockholders with its employees, including its officers, non-employee directors, consultants and advisers by providing equity-based incentives. The Plan allows for the issuance of up to 700,000 shares of the Company’s common stock. At June 30, 2019, there were 501,827 options outstanding under the Company’s 2009 Equity Incentive Plan, as amended. 

The types of awards that may be granted under the Plan include options (both non-qualified stock options and incentive stock options), stock appreciation rights, stock awards, stock units and other stock-based awards.  The term of each award is determined by the Compensation Committee of the Board at the time each award is granted, provided that the term of the option does not exceed ten years . Vesting schedules for stock options vary, but generally vest 25% per year, over four years for employee options and on the one year anniversary date for non-employee director options.  The Plan had 605,000 shares available for future grants as of June 30, 2019 .

Accounting for Stock-Based Compensation

The Company recognizes non-cash compensation expense for stock-based awards based on their grant date fair value, determined using the Black-Scholes option-pricing model. During the six months ended June 30, 2019 and June 30, 2018, the weighted average fair market value for options granted was $1.43 and $2.22 , respectively.
    
Total stock-based compensation expense recognized using the straight-line attribution method and included in operating expenses in the Condensed Consolidated Statements of Operations was approximately $0.2 million for the six-month period ended June 30, 2019 and approximately $0.3 million for the six-month period ended June 30, 2018.
    
Assumptions Used In Determining Fair Value of Stock Options

Inherent in the Black-Scholes option-pricing model are the following assumptions:

Volatility. The Company estimates stock price volatility based on the Company’s historical stock price performance over a period of time that matches the expected term of the stock options.

Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption.

Expected term . The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applied the simplified method of estimating the expected term of the options, described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

Dividend rate. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero.


    
    



34

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 9. Stock-Based Compensation (continued)

The fair market value of these stock options at the date of grant was estimated using the Black-Scholes option-pricing model with the following weighted average assumptions for the six months ended:
 
June 30, 2019
 
June 30, 2018
Expected term
6 years, 2 months

 
6 years

Interest rate
2.29
%
 
2.61
%
Dividend rate

 

Volatility
96.3
%
 
88.0
%

Stock Option Activity
    
The following table summarizes stock option activity for the six months ended June 30, 2019:
 
Number of
shares
 
Weighted-
average
exercise
price
 
Weighted- average
remaining
contractual
term
 
Aggregate
intrinsic
value
Outstanding at December 31, 2018
286,712

 
$
46.01

 
7 years

 
$

Granted
310,500

 
1.82

 
9 years, 11 months

 

Exercised

 

 

 

Forfeited

 

 

 

Expired
(385
)
 
18.05

 

 

Outstanding at June 30, 2019 (1)
596,827

 
$
23.04

 
8 years, 3 months

 
$
26

Exercisable at June 30, 2019
223,805

 
$
57.36

 
6 years

 
$

(1)
Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition.

The total fair value of options vested during the six months ended June 30, 2019 was approximately $0.5 million . Additionally, as of June 30, 2019 , there was approximately $0.7 million of unrecognized compensation expense related to non-vested stock options which is expected to be recognized over a weighted-average period of approximately 2 years, 9 months .
The Company accounts for forfeitures when they occur. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest.
Note 10. Related Party Transactions

The Company and Intrexon are parties to two distinct exclusive channel collaboration agreements including the Exclusive Channel Collaboration Agreement entered into in October 2012 and amended in June 2013 and January 2014 (as amended, the 2012 ECC) and the Exclusive Channel Collaboration Agreement entered into in December 2015 (the 2015 ECC). Pursuant to these agreements, the Company engages Intrexon for support services for the research and development of product candidates covered under the respective agreements and reimburses Intrexon for its cost for time and materials for such work. Additionally, the Company’s future commitments pursuant to the 2012 ECC agreement includes potential cash royalties and the Company’s future commitments pursuant to the 2015 ECC agreement includes potential cash royalties and various developmental milestone payments. The Company paid approximately $3.8 million in milestone payments in July 2019 to Intrexon under the 2012 ECC related to their portion of the CCP milestone payment made in April of 2019, and was expensed during the six months ended June 30, 2019.

For the six months ended June 30, 2019 and 2018, the Company incurred total expenses of approximately $0.1 million and $0.3 million , respectively, for goods and services received from Intrexon for work performed under the 2012 ECC. During

35

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
 
Note 10. Related Party Transactions (continued)

the same periods, no expenses were incurred for work performed under the 2015 ECC. Of the $0.1 million incurred during the six months ended June 30, 2019, approximately $0.01 million related to direct expenses for work performed by Intrexon and approximately $0.09 million related to pass-through costs. Of the approximately $0.3 million incurred in the six months ended June 30, 2018, approximately $0.1 million related to direct expenses for work performed by Intrexon and approximately $0.2 million related to pass-through costs. The Company’s FCX-007 and FCX-013 development programs are covered under the 2012 ECC and the Company’s arthritis and related conditions program is covered under the 2015 ECC. In addition to the amounts related to direct expenses for work performed, approximately $3.8 million in payments owed to Intrexon related to their portion of the initial CCP milestone payment made in April of 2019, was expensed during the six months ended June 30, 2019. These costs are presented in the Company’s “Condensed Consolidated Statement of Operations” as cost of license, cost of collaboration revenue and research and development expenses - related party.
   
As of June 30, 2019 and December 31, 2018 , the Company had outstanding payables to Intrexon of approximately $3.8 million and $0.1 million for each period respectively. These amounts are presented in the Company’s “Condensed Consolidated Balance Sheets” as related party payable.

    In the second quarter of 2017, Intrexon notified the Company that it had received invoices for approximately $1.1 million in charges from a vendor who provided services to Intrexon and which are passed-through to the Company under the 2012 ECC. Additional charges were presented after the second quarter of 2017, and the total of disputed charges at March 31, 2018, was approximately $1.4 million . The Company, Intrexon and Intrexon’s vendor resolved the dispute with the parties agreeing to settle all obligations for approximately $0.2 million . This was a reduction of approximately $0.5 million from the approximately $0.7 million recorded at December 31, 2017 for this liability and was recorded in the three months ended March 31, 2018. The approximately $0.2 million settlement amount was paid in the Company’s third fiscal quarter of 2018.

Randal J. Kirk is the chairman of the board and chief executive officer of Intrexon and, together with his affiliates, owns more than 50% of Intrexon’s common stock. Affiliates of Randal J. Kirk (including Intrexon) own approximately 17% of the Company’s common stock. Additionally, two of the Company’s directors, Julian Kirk (who is the son of Randal J. Kirk) and Marcus Smith, are employees of Third Security, LLC, which is an affiliate of Randal J. Kirk.

Affiliates of Randal J. Kirk (including Intrexon) participated in the Company’s private placement of convertible debt securities in September 2016, more fully described in Note 6, and were issued an aggregate of $6,762,500 in principal of Notes and accompanying Warrants to purchase an aggregate of 450,835 shares of the Company’s common stock. Affiliates of Randal J. Kirk (including Intrexon) participated in the Company's 2017 Series A Preferred Stock Offering (as defined below), more fully described in Note 11, and were issued an aggregate of 3,016 shares of Series A Preferred Stock (as defined below) and accompanying Series A Warrants to purchase 259,176 shares of the Company’s common stock. Additionally, affiliates of Randal J. Kirk (including Intrexon) participated in the December 2017 Offering, and were issued an aggregate of 545,456 shares of the Company’s common stock and accompanying warrants to purchase 545,456 shares of the Company’s common stock.
Note 11.  Income (Loss) Per Share
    
Basic income (loss) per share is computed by dividing net income (loss) for the period by the weighted average number of shares of common stock outstanding during that period. The diluted income (loss) per share calculation gives effect to dilutive stock options, warrants, convertible preferred stock, convertible notes and other potentially dilutive common stock equivalents outstanding during the period. Diluted income (loss) per share is based on the if-converted method or the treasury stock method, as applicable, and includes the effect from the potential issuance of common stock, such as shares issuable pursuant to the conversion of convertible preferred stock, convertible notes and the exercise of stock options and warrants, assuming the exercise of all "in-the-money" common stock equivalents based on the average market price during the period. Common stock equivalents have been excluded where their inclusion would be anti-dilutive.

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Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 11. Income (Loss) Per Share (continued)

Details in the computation of basic and diluted income (loss) per share is as follows:
 
Three months ended June 30,
 
Six months ended  June 30,
($ in thousands except share and per share data)
2019
 
2018
 
2019
 
2018
Income (loss) per share - basic:
 
 
 
 
 
 
 
Net income (loss)
$
11,743

 
$
(2,894
)
 
$
8,077

 
$
(5,795
)
Less: Dividend paid in-kind to preferred stockholders
(86
)
 
(83
)
 
(171
)
 
(165
)
Less: Deemed dividend on preferred stock
(145
)
 
(126
)
 
(285
)
 
(247
)
Net income (loss) attributable to common stockholders - basic
$
11,512

 
$
(3,103
)
 
$
7,621

 
$
(6,207
)
 
 
 
 
 
 
 
 
Numerator for basic income (loss) per share
$
11,512

 
$
(3,103
)
 
$
7,621

 
$
(6,207
)
Denominator for basic income (loss) per share
9,758,332

 
6,376,048

 
9,758,332

 
6,026,454

Basic income (loss) per common share
$
1.18

 
$
(0.49
)
 
$
0.78

 
$
(1.03
)
 
 
 
 
 
 
 
 
Income (loss) per share - diluted:
 
 
 
 
 

 
 

Numerator for basic income (loss) per share
$
11,512

 
$
(3,103
)
 
$
7,621

 
$
(6,207
)
Adjust: Interest and derivative revaluation expense related to convertible notes
1,338

 

 

 

Adjust: Paid in kind dividend on preferred shares
86

 

 
171

 

Adjust: Deemed dividend on preferred shares
145

 

 
285

 

Net income (loss) attributable to common stockholders - diluted
$
13,081

 
$
(3,103
)
 
$
8,077

 
$
(6,207
)
 
 
 
 
 
 
 
 
Denominator for basic income (loss) per share
9,758,332

 
6,376,048

 
9,758,332

 
6,026,454

Plus: Incremental shares underlying dilutive “in the money” stock options outstanding
25,257

 

 
11,483

 

Plus: Incremental common shares underlying convertible notes and related accrued interest
1,169,714

 

 

 

Plus: Incremental common shares underlying preferred stock
744,088

 

 
740,066

 

Denominator for diluted income (loss) per share
11,697,391

 
6,376,048

 
10,509,881

 
6,026,454

Diluted net income (loss) per common share
$
1.12

 
$
(0.49
)
 
$
0.77

 
$
(1.03
)

The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding, as their effect would be anti-dilutive: 
 
Three months ended June 30,
 
Six months ended  June 30,
 
2019
 
2018
 
2019
 
2018
“In the money” stock options

 
36,000

 

 
36,000

“Out of the money” stock options
286,327

 
263,467

 
286,327

 
263,467

“In the money” warrants

 
1,528,668

 

 
1,528,668

“Out of the money” warrants
7,392,966

 
4,903,736

 
7,392,966

 
4,903,736

Shares underlying convertible notes

 
1,056,068

 
1,056,068

 
1,056,068

Shares underlying convertible accrued interest on convertible notes

 
79,120

 
125,213

 
79,120

Shares underlying convertible preferred stock

 
720,000

 

 
720,000


37

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)

Note 12.  Equity

Preferred Stock

The Company is authorized to issue 5,000,000 shares of preferred stock, at a par value of $0.001 per share, in one or more series and to fix the rights, preferences, privileges, and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. The issuance of the Company’s preferred stock could adversely affect the voting power of holders of the Company’s common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change of control of the Company or other corporate action.
    
Series A Convertible Preferred Stock     

In March 2017, the Board authorized the issuance of 8,000 shares of preferred stock designated as Series A Convertible Preferred Stock (the Series A Preferred Stock). The rights, preferences and privileges of the Series A Preferred Stock are set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock dated March 7, 2017 (Certificate of Designation).

On March 7, 2017, the Company entered into a securities purchase agreement with certain of its existing accredited investors pursuant to which the Company agreed to sell a total of 8,000 units (the Units) for a purchase price of $1,000 per Unit, with each Unit consisting of (i) one share of the Series A Preferred Stock, with an initial stated value of $1,000 and which is convertible into shares of the Company’s common stock with a conversion price of $11.6355 and (ii) a warrant to purchase up to a number of shares of the Company’s common stock equal to 100% of the conversion shares issuable on March 7, 2017 pursuant to the shares of Series A Preferred Stock purchased by each investor (the Series A Warrants and, collectively, the 2017 Series A Preferred Stock Offering). See Note 6 for discussion of the Series A Warrants issued in connection with the 2017 Series A Preferred Stock Offering. The 2017 Series A Preferred Stock Offering closed on March 8, 2017 and resulted in gross proceeds of $ 8.0 million , before deducting offering costs.

The proceeds from the 2017 Series A Preferred Stock Offering (including offering costs) were allocated between the Series A Warrants and Series A Preferred Stock issued in the transaction based upon their respective fair values using the relative fair value (proportional) method. The fair value of the Series A Preferred Stock issued was calculated as the sum of (i) the value of the Series A Preferred Stock as if it had been converted into the Company’s common stock on the issuance date and (ii) the value of a perpetual annuity paying a 4% dividend rate in conversion shares for five years and 8% thereafter. In connection with the valuation, the following assumptions were used: risk free interest rate of 3.15% , credit spread of 31.27% and a market yield of 34.42% . The application of the relative fair value method resulted in an allocation of gross proceeds to the Series A Preferred Stock of approximately $1.3 million , net of discounts of $3.0 million attributed to the warrants (See Note 5) and $3.7 million from a beneficial conversion feature. The discount attributed to the beneficial conversion feature was immediately amortized as the Series A Preferred Stock has no stated redemption date and is convertible at the issuance date. For the six months ended June 30, 2019 and 2018, the Company recognized approximately $0.1 million in both periods of amortization of the discount on the Series A Preferred Stock as deemed dividends charged to additional paid-in capital (in the absence of retained earnings). The value of the beneficial conversion feature is calculated as the difference between the effective conversion price of the Series A Preferred Stock and the fair market value of the common stock into which the Series A Preferred Stock are convertible at the commitment date.

The discount attributed to the warrants is being accreted using the effective interest method and charged as a deemed dividend to additional paid-capital (in the absence of retained earnings), over the five -year period of the Series A Preferred Stock in which the stated dividend rate is 4% . For the six months ended June 30, 2019 and 2018, the Company recognized approximately $0.3 million and $0.2 million , respectively, in deemed dividends due to the accretion of the warrant discount.

The 2017 Series A Preferred Stock Offering securities purchase agreement contains customary representations, warranties, and agreements by the Company. The securities purchase agreement also contains customary prohibitions on

38

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 12. Equity (continued)


certain Company payments, the incurrence of certain senior and pari passu debt, certain affiliate transactions and the incurrence of certain liens.

Holders of the Series A Preferred Stock are entitled to receive cumulative dividends at a rate per share of 4% per annum (with such dividend rate increasing to 8% per annum on the five year anniversary of the original issuance of the Series A Preferred Stock), with such dividends compounded quarterly and payable only by way by increasing the stated value of the
Series A Preferred Stock in accordance with the terms of the Certificate of Designation. For the six months ended June 30, 2019 and 2018, cumulative dividends paid in-kind to holders of the Series A Preferred Stock were approximately $0.8 million and $0.4 million , respectively.

Shares of Series A Preferred Stock generally have no voting rights, except as required by law; provided, however, that without the prior written consent of the holders of at least 70% of the then outstanding shares of Series A Preferred Stock, the Company may not: (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation; (ii) amend the Company’s certificate of incorporation or other charter documents in any manner that adversely affects any rights of a holder of the Series A Preferred Stock; (iii) authorize or create any class of stock ranking as to redemption, distribution of assets upon liquidation or dividends senior to, or otherwise pari passu with, the Series A Preferred Stock; (iv) declare or make any dividends other than dividend payments or other distributions payable solely in the Company’s common stock; or (v) enter into any agreement with respect to any of the foregoing.

Upon a liquidation, dissolution or winding up of the Company, the holders of the Series A Preferred Stock are entitled to receive out of the Company’s assets, whether capital or surplus, an amount equal to such holder’s then stated value for each share of Series A Preferred Stock before any distribution to the holders of the Company’s common stock, any class or series of preferred stock and all other common stock equivalents other than those securities which are explicitly senior or pari passu to the Series A Preferred Stock in redemption, distribution of assets upon a liquidation or dividends. If there are insufficient assets to pay in full such amounts, then the available assets will be ratably distributed to the holders of the Series A Preferred Stock in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full.

Common Stock

In July 2016, the Company amended its Restated Certificate of Incorporation, as amended, to increase the number of shares of common stock that the Company is authorized to issue from 100,000,000 to 150,000,000 .

On May 24, 2018, the Company implemented the Reverse Stock Split, as authorized at the annual meeting of stockholders on May 23, 2018. The Reverse Stock Split became effective on May 24, 2018 at 5:00 pm and the Company’s common stock began trading on Nasdaq on a post-split basis at the open of business on May 25, 2018. As of a result of the Reverse Stock Split, every five shares of the Company’s issued and outstanding common stock were combined into one share of its common stock, except to the extent that the Reverse Stock Split resulted in any of the Company’s stockholders owning a fractional share, which was rounded up to the next highest whole share. In connection with the Reverse Stock Split, there was no change in the nominal par value per share of $0.001 . The Reverse Stock Split was effectuated in order to increase the per share trading price of the Company’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on Nasdaq. By letter dated June 11, 2018, the Nasdaq Listing Qualification Department, confirmed that the Company’s common stock was in compliance with listing requirements.

December 2017 Public Offering

On December 7, 2017, the Company entered into an underwriting agreement (the Underwriting Agreement) with Wainwright, relating to the sale of 1,542,832 shares of its common stock, pre-funded warrants to purchase an aggregate of 1,184,442 shares of the Company’s common stock and common warrants to purchase up to an aggregate of 2,727,273 shares of the Company’s common stock in connection with the December 2017 Offering. Each share of the Company’s common stock or pre-funded warrant, as applicable, was sold together with a common warrant to purchase one share of the Company’s common stock at a combined effective price to the public of $3.85 per share and accompanying common warrant. At March 31, 2018, all of the pre-funded warrants had been exercised for 1,184,442 shares of the Company’s common stock.


39

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 12. Equity (continued)


Pursuant to the Underwriting Agreement, the Company granted Wainwright a thirty day option, which option ended on January 6, 2018, to purchase up to 409,091 additional shares of the Company’s common stock at a purchase price of $3.80 per share and/or common warrants to purchase up to an aggregate of 409,091 shares of the Company’s common stock at a purchase price of $0.01 per common warrant with an exercise price of $3.85 per share, less the underwriting discounts and commissions. On December 8, 2017, Wainwright partially exercised this option by purchasing common warrants to purchase 82,118 shares of the Company’s common stock. As additional compensation, the Company issued warrants to Wainwright to purchase 87,274 shares of the Company’s common stock (the Underwriter Warrants). The Underwriter Warrants, which have an exercise price of $4.8125 per share, are exercisable for five years from the date of the Underwriting Agreement and may be exercised on a cashless basis in certain circumstances specified therein.
    
The Company and Wainwright completed the December 2017 Offering on December 11, 2017, resulting in approximately $9.3 million of net proceeds to the Company after deducting the underwriter’s discounts and commissions and other estimated offering expenses payable by the Company.

The common warrants are exercisable immediately at an exercise price of $3.85 per share and will expire five years from the date of issuance. The pre-funded warrants are exercisable immediately at an exercise price of $0.05 per share and may be exercised until they are exercised in full, and as of June 30, 2019 all pre-funded warrants had been exercised. The exercise price and number of shares of the Company’s common stock issuable upon exercise of the common warrants, pre-funded warrants and Underwriter Warrants will be subject to adjustment in the event of any stock split, reverse stock split, stock dividend, recapitalization, reorganization or similar transaction, among other events as described in the common warrants and pre-funded warrants.

In the event of certain transactions involving a sale of the Company, each holder of common warrants has the right, exercisable at its option, to require the Company to purchase such holder’s common warrants at a price determined using a Black Scholes option pricing model as described in the common warrants. The shares of the Company’s common stock or pre-funded warrants, as applicable, and the accompanying common warrants could only be purchased together in the December 2017 Offering but were issued separately.

May 2018 Registered Direct Offering and Private Placement

On May 29, 2018, in connection with the May 2018 Registered Direct Offering, the Company entered into securities purchase agreements (May 2018 Purchase Agreements) with certain institutional and accredited investors for the sale by the Company of 2,038,224  shares of the Company’s common stock, par value $0.001 per share at a purchase price of $2.85 per share. Concurrently with the May 2018 Registered Direct Offering, and pursuant to the May 2018 Purchase Agreements, the Company in connection with the May 2018 Private Placement, also sold unregistered warrants exercisable for an aggregate of 1,528,668  shares of the Company’s common stock, which represents 75% of the shares of the Company’s common stock sold in the May 2018 Registered Direct Offering, for a purchase price of $0.125 per warrant and with an exercise price of $2.86 per share. Subject to certain ownership limitations, the warrants were exercisable upon issuance. The warrants will expire on the 5.5 years anniversary of the date of issuance. The May 2018 Purchase Agreements contain representations, warranties and covenants of the investors and the Company that are customary for transactions of this type.

The May 2018 Registered Direct Offering and the May 2018 Private Placement closed on May 31, 2018. The net proceeds from the transactions were approximately $5.3 million after deducting certain fees due to the placement agent and other estimated transaction expenses. In connection with the May 2018 Registered Direct Offering and the May 2018 Private Placement, the placement agent received warrants to purchase up to 7.0% of the aggregate amount of shares of Company common stock sold in the May 2018 Registered Direct Offering. The warrants issued to the placement agent have substantially the same terms as the warrants issued in the May 2018 Private Placement, except that the exercise price of the warrants issued to the placement agent is $3.679 per share and the term of the warrants issued to the placement agent is five years .







40

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 12. Equity (continued)


July 2018 Registered Direct Offering and Private Placement

On July 2, 2018, the Company entered into securities purchase agreements (July 2018 Purchase Agreements) with certain institutional and accredited investors for the sale by the Company of 1,474,080 shares of the Company’s common stock, par value $0.001 per share at a purchase price of $2.69 per share (the July 2018 Registered Direct Offering). Concurrently with the July 2018 Registered Direct Offering, and pursuant to the July 2018 Purchase Agreements, the Company also sold unregistered warrants exercisable for an aggregate of 958,152 shares of the Company’s common stock, which represents 65% of the shares of the Company’s common stock sold in the July 2018 Registered Direct Offering, for a purchase price of $0.125 per warrant and with an exercise price of $2.70 per share (July 2018 Private Placement). Subject to certain ownership limitations, the warrants were exercisable upon issuance. The warrants will expire on the 5.5 years anniversary of the date of issuance.

The July 2018 Registered Direct Offering and the July 2018 Private Placement closed on July 5, 2018. The net proceeds from the transactions were approximately $3.6 million after deducting certain fees due to the placement agent and other estimated transaction expenses. In addition, the placement agent received warrants to purchase 103,186 shares of the Company’s common stock. The warrants issued to the placement agent have substantially the same terms as the warrants issued in the July 2018 Private Placement, except that the exercise price of the warrants issued to the placement agent is $3.464 per share and the term of the warrants issued to the placement agent is five years .

On July 27, 2018, the Company filed a registration statement on Form S-1, registering the resale of shares of the Company’s common stock underlying warrants issued in the May 2018 Private Placement and the July 2018 Private Placement. The Resale Registration Statement was declared effective by the SEC on August 8, 2018.

December 2018 Private Placement

On December 11, 2018, the Company completed the sale of 443,350 shares of its common stock (the December 2018 Private Placement), for approximately $0.9 million . After deducting offering expenses, net proceeds from the December 2018 Private Placement was approximately $0.8 million .



41

Table of Contents
Fibrocell Science, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Note 12. Equity (continued)


Note 13.  Income taxes

For the three months ended March 31, 2019 and 2018, the Company did no t record a tax expense or benefit. The effective tax rate for the three months ended March 31, 2019 and 2018 was 0% . The effective tax rate for the three months ended March 31, 2019 and 2018 differs from the statutory tax rate due to expected current year and historical losses.  For the six months ended June 30, 2019 and 2018, the Company recorded a tax expense of $0.6 million and $0 , respectively. The effective tax rate for the six months ended June 30, 2019 and 2018 was 7.23% and 0% , respectively. The effective tax rate for the six months ended June 30, 2019 differs from the statutory rate primarily due to Pennsylvania state taxes that result from Pennsylvania’s limitation on the use of net operating losses allowed to be utilized against Pennsylvania taxable income generated as a result of the revenue recorded from the CCP Agreement. The Company does not have a net deferred tax asset because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is more likely than not, that the Company will be unable to realize these future tax benefits. As of June 30, 2019, the Company had no uncertain tax positions.


42

Table of Contents

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis should be read in conjunction with:
our unaudited Condensed Consolidated Financial Statements and accompanying notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q (this Form 10-Q); and
our audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for 2018 (2018 Form 10-K), as well as the information contained under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2018 Form 10-K.
Overview

We are a cell and gene therapy company focused on improving the lives of people with rare diseases of the skin and connective tissue. We are utilizing our proprietary autologous fibroblast technology to develop personalized biologics that target the underlying cause of disease.  Fibroblasts are the most common cell in skin and connective tissue and are responsible for synthesizing extracellular matrix proteins, including collagen and other growth factors, that provide structure and support. Because fibroblasts naturally reside in the localized environment of the skin and connective tissue, they represent an ideal delivery vehicle for proteins targeted to these areas.  We target the underlying cause of disease by using fibroblast cells from a patient’s skin and genetically modifying them to create localized therapies that are compatible with the unique biology of the patient (i.e., which are autologous).

Our pipeline of localized gene therapy candidates include FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a life-threatening genetic disorder diagnosed in infancy with no cure or treatment approved by the U.S. Food and Drug Administration (FDA). We are also developing FCX-013 for the treatment of moderate to severe localized scleroderma. Currently, all of our research and development operations and focus are on gaining regulatory approvals to commercialize our gene therapy candidates in the United States; however, we may seek to expand into international markets in the future.

On April 12, 2019, we entered into a co-development and license agreement (CCP Agreement) with Castle Creek Pharmaceuticals, LLC (CCP) with respect to the development and commercialization of our lead gene therapy candidate, FCX-007, for the treatment of RDEB.

Under the terms of the CCP Agreement, CCP will receive an exclusive license to commercialize FCX-007 in the United States. CCP will be responsible for the first $20 million in development costs prior to the initial Biologics License Application (BLA) filing with U.S. Food and Drug Administration (FDA) and manufacturing costs undertaken prior to commercial launch of FCX-007. If such spending exceeds $20 million, CCP will be responsible for 70% of the excess costs and we will cover 30% of the remaining additional expenses. We will maintain responsibility for the development (including pre-launch manufacturing) of FCX-007 through initial BLA approval of FCX-007, and CCP will be responsible for all post-approval development and commercialization activities for FCX-007. The parties have agreed to negotiate the terms of a manufacturing and supply agreement that will set forth the terms under which we will supply CCP commercial quantities of FCX-007. A joint development committee consisting of representatives from our company and CCP will oversee the development of FCX-007 pursuant to an agreed-upon development plan and budget.

At the closing of the CCP Agreement, we received an upfront payment of $7.5 million, and will receive an additional $2.5 million for the first patient enrolled in the Phase 3 clinical trial of FCX-007 and $30 million upon BLA approval of FCX-007 and FCX-007 commercial manufacturing readiness. We are also eligible to receive up to $75 million in sales milestones, consisting of $25 million upon the achievement of $250 million in cumulative FCX-007 net sales and an additional $50 million upon the achievement of $750 million in cumulative FCX-007 net sales. In addition, CCP will pay us a 30% share of the gross profits from FCX-007 sales. We will retain sole ownership of the Rare Pediatric Disease Priority Review Voucher (PRV), which may be granted upon BLA approval of FCX-007. A PRV can be used to obtain priority review for a subsequent New Drug Application or BLA, and can be sold to another entity.

As part of our existing exclusive channel collaboration agreement with Intrexon Corporation (Intrexon), we will pay Intrexon 50% of all upfront, milestone and profit share payments from CCP. Payments to Intrexon do not include funds received from CCP in connection with the development and manufacturing costs or payments for supply of FCX-007.


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Unless earlier terminated, the CCP Agreement will expire on the later of (a) expiration of the last-to-expire valid claim of any FCX-007 patent rights in the United States and (b) forty years from the date of initial BLA approval of FCX-007.

CCP has the right to terminate the CCP Agreement at will upon 180 days’ prior written notice. If CCP elects to terminate the agreement at will, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory pay to CCP an amount equal to five percent (5%) of product gross profit in respect of sales of the product in the territory by the Company, its affiliates or licensees in the Initial Indication and any additional indications developed or commercialized by the parties as of the effective date of termination.

CCP may also terminate the CCP Agreement at any time, upon 180 days’ prior written notice to the Company, in the event (i) CCP determines, in its reasonable discretion, that further development or commercialization of FCX-007 is not commercially viable or (ii) CCP determines that development or commercialization of FCX-007 must be terminated because of safety issues outside of CCP’s reasonable control. If CCP elects to terminate the agreement due to either of the specified reasons set forth in the preceding sentence, then, among other things, the license granted to CCP will terminate and all rights will revert in their entirety to the Company. In the event of such a termination, the Company shall upon first commercial sale by the Company, its affiliates or licensees in the territory, pay to CCP an amount equal to five percent (5%) of FCX-007 gross profit in respect of sales of FCX-007 in the territory by the Company, its affiliates or licensees in the Initial Indication and any additional indications developed or commercialized by the parties as of the effective date of termination. Either party may, subject to specified cure periods, terminate the CCP Agreement in the event of the other party’s uncured material breach, and either party may terminate the CCP Agreement under specified circumstances relating to the other party’s insolvency. The upfront payment and milestone payments are non-refundable; provided, however, that certain disputed payments may be refunded in accordance with the dispute resolutions procedures set forth in the CCP Agreement.

Based on our receipt of the upfront payment from CCP and reduction of expenses associated with the development of FCX-007, we believe our existing cash will be sufficient to fund operations into the third quarter of 2020.

In connection with the execution of the CCP Agreement with CCP, we concluded our strategic alternative review process announced last year.

Development Programs

Our current pipeline consists of the following product candidates, which we are developing in collaboration with Intrexon and CCP (FCX-007 only):

PIPELINEGRAPH6302019A.JPG





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FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

FCX-007 is our clinical-stage, gene therapy product candidate for the treatment of RDEB, a congenital and progressive orphan skin disease caused by the deficiency of type VII collagen (COL7). FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7 for localized treatment of RDEB and is being developed in collaboration with Intrexon. By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas, thereby avoiding systemic treatment.

Phase 2 Portion of Phase 1/2 Trial of FCX-007 for RDEB

In January 2018, Fibrocell obtained allowance from the FDA to initiate enrollment of pediatric patients in the Phase 2 portion of its Phase 1/2 clinical trial of FCX-007, based on evidence of safety and potential benefit of FCX-007 in adult patients dosed in the Phase 1 portion of the clinical trial. In May 2018, we reported on interim adult data and provided a Phase 1 trial update which included presenting at the 7th International Investigative Dermatology meeting on May 19, 2018.

We completed the targeted enrollment of six patients ages seven and older in the Phase 2 portion of the Phase 1/2 clinical trial for FCX-007, and have over-enrolled by one patient for a total of seven patients. The Phase 2 population consists of one adult and six pediatric patients. In March 2019, we reported additional positive safety and wound healing data for our ongoing Phase 1/2 trial. To date, FCX-007 has been evaluated in eight wounds across five adult patients. In addition, we completed dosing of a sixth patient—the first pediatric patient treated in the Phase 2 portion of the Phase 1/2 trial for FCX-007—using the expected Phase 3 clinical trial dose regimen. We plan to continue the remaining follow-up visits with all Phase 1/2 patients, but do not intend to dose additional patients as part of the trial. Remaining Phase 2 patients who have not received dosing will be contacted to determine if they would agree to reconsent to participate in the Phase 3 trial of FCX-007.

FCX-007 Phase 3 Clinical Trial

    In October 2018, we completed a Type C meeting with the FDA to discuss the design of a Phase 3 clinical trial protocol for FCX-007. The FDA provided guidance on various clinical trial design aspects and Chemistry, Manufacturing and Control (CMC) requirements of the proposed Phase 3 clinical trial. In November 2018, we received the official minutes from the FDA for the Type C meeting. Based on FDA’s feedback, we prepared a Phase 3 clinical trial protocol for FCX-007 and filed it as part of the briefing package for the Type B meeting in March 2019. We completed a Type B end-of-Phase 2 face-to-face meeting with the FDA in March 2019 to discuss the design of a Phase 3 clinical trial for FCX-007 to support a BLA filing. In the Type B meeting, the FDA provided guidance on various design aspects of our Phase 3 clinical trial, named DEFI-RDEB (dermal fibroblasts-RDEB). Based on the FDA’s guidance, we updated the CMC information filed to the IND in early July 2019. Timing of the updated CMC submission was a strategic decision by us to provide the FDA with time to review the CMC information prior to filing the Phase 3 protocol to mitigate potential review issues.

In late July 2019, we submitted the revised Phase 3 clinical trial protocol to the FCX-007 IND and initiated the Phase 3 trial of FCX-007. The Phase 3 trial is designed as an open label, multi-centered, intra-patient controlled trial expected to enroll 15-20 patients. The Phase 3 trial’s primary outcome measure is the comparison of the proportion of FCX-007 treated and untreated matched wounds with complete wound closure at week 12.

We have executed several start-up tasks for the FCX-007 Phase 3 trial, including completion of a Request for Proposal (RFP) process and selection of a Clinical Research Organization (CRO) to manage the trial; hiring and onboarding of key internal personnel in both regulatory and clinical operations leadership; and ramp-up of staffing in manufacturing and quality.

We continue to project enrollment and dosing of Phase 3 patients will be completed in the third quarter of 2020 and data collection for the primary endpoint will be completed in the fourth quarter of 2020.  If the Phase 3 trial is successful and completed within our projected timeframe, we expect to file a BLA for FCX-007 in 2021.

We have designated our existing, cGMP cell therapy manufacturing facility in Exton, PA as the production site for FCX-007 after incorporation into our IND application. Our multi-product, gene therapy manufacturing facility will be used for the remaining clinical and, if approved, future commercial manufacture of FCX-007, to serve the U.S. market for RDEB.

FCX-007 has received Orphan Drug Designation for the treatment of DEB, including RDEB, Rare Pediatric Disease Designation for the treatment of RDEB and Fast Track Designation for the treatment of RDEB from the FDA. In May 2019, the FDA granted the Regenerative Medicine Advanced Therapy (RMAT) Designation to FCX-007 for the treatment of RDEB.

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FCX-013 for Moderate to Severe Localized Scleroderma

In addition, our second clinical stage gene therapy candidate, FCX-013 is in development for the treatment of moderate to severe localized scleroderma, which manifests as excess production of extracellular matrix, specifically collagen, resulting in thickening of the skin and connective tissue. FCX-013 is designed to be injected under the skin at the location of the fibrotic lesions where the genetically-modified fibroblast cells will produce matrix metalloproteinase 1 (MMP-1) to break down excess collagen accumulation. We previously completed a proof-of-concept study and pre-clinical dose-ranging study for FCX-013. In December 2017, we completed a GLP toxicology/biodistribution study. We submitted an IND application for FCX-013 to the FDA in January 2018, and in March 2018, the FDA allowed the IND to progress to clinical trials. We initiated the first investigator site for clinical enrollment for an open label, single arm Phase 1/2 clinical trial. We are currently enrolling the Phase 1 portion of the Phase 1/2 clinical trial for FCX-013, and expect to complete enrollment of Phase 1 adult patients in the third quarter of 2019. We project that safety and efficacy data for the adult patients in the Phase 1 portion of the trial will be available in mid-2020. In addition, we feel FCX-013 may have future potential to expand into its own pipeline, with applications in other sclerotic disorders. We plan to manufacture FCX-013 at our Exton, PA cGMP manufacturing facility.

FCX-013 has received Orphan Drug Designation from the FDA for the treatment of localized scleroderma and Rare Pediatric Disease Designation and in September 2018, Fast Track Designation for moderate to severe localized scleroderma.

Gene Therapy Research Program for Arthritis and Related Conditions

We expanded our collaboration with Intrexon to pursue the research, development and commercialization of products for the treatment of chronic inflammation and degenerative diseases of human joints through intra-articular or other local administration of genetically modified fibroblasts. We are currently in the research phase for a gene therapy to treat arthritis and related conditions under this collaboration. Our goal is to deliver a protein therapy locally to the joint to provide sustained efficacy while avoiding key side effects typically associated with systemic therapy.


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Financial Condition, Liquidity and Capital Resources

Financial Condition
    
We have experienced losses since our inception. As of June 30, 2019 , we had an accumulated deficit of approximately $181.0 million . The process of developing and commercializing our product candidates requires significant research and development efforts and clinical trial work, as well as significant manufacturing and process development. These activities, together with our selling, general and administrative expenses, are expected to continue to result in significant operating losses for the foreseeable future.

Our financial condition is summarized below as of the following dates and is intended to supplement the more detailed discussion that follows:
 
June 30, 2019
 
December 31, 2018
($ in thousands)
 
Cash and cash equivalents
$
13,675

 
$
14,430

 
 
 
 
Working capital:
 
 
 
Total current assets
$
24,866

 
$
14,535

Less: Total current liabilities
7,101

 
2,172

Net working capital
$
17,765

 
$
12,363

 
 
 
 
Convertible notes payable (gross principal)
$
18,003

 
$
18,003

 
 
 
 
Stockholders’ equity
$
17,863

 
$
9,557


Liquidity and Capital Resources
    
Our principal sources of liquidity are cash and cash equivalents of $13.7 million and net working capital of $17.8 million as of June 30, 2019 . Net working capital increased approximately $5.4 million , or 43.7% , from December 31, 2018 to June 30, 2019 . This increase is the result primarily from the net income recorded for the first six months of 2019.
Under the terms of the CCP Agreement, we will receive $2.5 million for the first patient enrolled in the Phase 3 clinical trial of FCX-007 and $30 million upon BLA approval of FCX-007 and FCX-007 commercial manufacturing readiness. We are also eligible to receive up to $75 million in sales milestones, consisting of $25 million upon the achievement of $250 million in cumulative FCX-007 net sales and an additional $50 million upon the achievement of $750 million in cumulative FCX-007 net sales. In addition, CCP will pay us a 30% share of the gross profits from FCX-007 sales.
As part of our existing exclusive channel collaboration agreement with Intrexon, we will pay Intrexon 50% of all upfront, milestone and profit share payments from CCP. Payments to Intrexon do not include funds received from CCP in connection with the development and manufacturing costs or payments for the supply of FCX-007.
We believe that our cash and cash equivalents at June 30, 2019 and amounts paid or payable to the Company under the CCP Agreement, including reimbursement of the FCX-007 development cost and the $2.5 million milestone payment for the first patient enrolled in the FCX-007 clinical trial will be sufficient to fund operations into the third quarter of 2020. However, changing circumstances may cause us to consume capital faster than we currently anticipate, and we may need to spend more money than currently expected because of such circumstances. We will require additional capital to fund operations beyond that point and prior to our business achieving significant net cash from operations.
Our future capital requirements may be substantial, and will depend on many factors, including, but not limited to:
the cost of clinical activities and outcomes related to our Phase 1/2 clinical trial for FCX-007 and our Phase 3 clinical trial for FCX-007;

the costs of clinical activities related to FCX-013, for which we received FDA allowance for our IND in the first quarter of 2018;


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the cost of additional pre-clinical studies and clinical trials in order to obtain regulatory approvals for our product candidates;

the cost of regulatory submissions, as well as the preparation, initiation and execution of clinical trials in potential new clinical indications; and

the cost of filing, surveillance around, prosecuting, defending and enforcing patent claims.

To meet our capital needs, we will consider multiple alternatives, including but not limited to equity financings, debt financings, corporate collaborations, partnerships and other strategic transactions and funding opportunities. However, there is no assurance that we will be able to complete any such transaction or obtain the additional required capital on acceptable terms or otherwise. Furthermore, the covenants under our convertible notes limit our ability to obtain additional debt financing. If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, will result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt or equity financing that we complete may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. If we raise additional funds through collaboration or partnership arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will need to curtail and reduce our operations and costs and modify our business strategy which may require us to, among other things:
significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives;
seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
sell or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.

Additionally, failure to obtain the necessary capital in a timely manner could require us to seek bankruptcy protection or result in our breach or default under agreements on which our business relies or pursuant to which we obtain valuable rights which could result in, among other things, the potential acceleration of payments thereunder or the termination of such agreements.

Cash Flows

Our cash flow activity is summarized below for the following periods:
 
Six months ended June 30,
($ in thousands)
2019
 
2018
Net cash flows (used in) provided by:
 
 
 
Operating activities
$
(646
)
 
$
(7,476
)
Investing activities
$
(87
)
 
$
(83
)
Financing activities
$
(22
)
 
$
5,552


Operating Activities. Cash used in operating activities during the six months ended June 30, 2019 was approximately $ 0.6 million , which is approximately $6.8 million, or 91% less than the six months ended June 30, 2018. This decrease was primarily the result of the receipt of the $7.5 million milestone received under the CCP agreement in April 2019.

Investing Activities. Cash used in investing activities during both the six months ended June 30, 2019 and 2018 was related solely to equipment and leasehold improvement purchases.

Financing Activities. Cash used in financing activities during the six months ended June 30, 2019 was for offering costs related to the December 2018 Private Placement, and cash provided by financing activities for the six months ended June 30, 2018 was from proceeds related to the May 2018 Registered Direct Offering and the conversion of warrants into common shares.

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Results of Operations

Comparison of Three and Six Months Ended June 30, 2019 and 2018

Revenue

For both the three and six months ended June 30, 2019, we recognized approximately $21.2 million in revenue for the first milestone in the CCP agreement, related to the purchase of an exclusive license to commercialize FCX-007 in the United States. In addition we recognized approximately $0.8 million in revenue related to the reimbursement of expenses for FCX-007 in the three and six months ended June 30, 2019, all related to the CCP agreement. See Note 4 for further details on the recognition of revenue related to the CCP agreement. We had no revenues for the 2018 periods.

Cost of Revenues

For both the three and six months ended June 30, 2019, we recognized approximately $5.2 million in expenses. These expenses were the result of an approximately $3.8 million license fee to our clinical partner Intrexon, and approximately $1.4 million in research and development expenses covered under the CCP agreement for reimbursement.         

Research and Development Expense
    
For each of our research and development programs, we incur both direct and indirect expenses. We track direct research and development expenses by program, which include third party costs such as contract research, consulting and preclinical development costs and clinical trial and manufacturing costs. We do not allocate indirect research and development expenses, which may include regulatory, laboratory (equipment and supplies), personnel, facility, process development and other overhead costs (including depreciation and amortization), to specific programs, as these expenses are to be deployed across all of our product candidates. We expect research and development costs to be reduced significantly for the foreseeable future as a result of our ongoing collaboration with CCP.
    
Direct research and development costs, by major program, and indirect research and development costs, by major component, were as follows:
 
For the Three Months Ended June 30,
 
For the Six Months
Ended June 30,
 
($ in thousands)
2019
 
2018
 
% Change
 
2019
 
2018
 
% Change
 
Direct costs:
 
 
 
 
 
 
 

 
 

 
 

 
FCX-007
$
28

 
$
203

 
(86.2
)%
 
$
784

 
$
136

 
476.5
 %
(1)
FCX-013
38

 
76

 
(50.0
)%
 
69

 
340

 
(79.7
)%
(2)
Other

 
5

 
(100.0
)%
 
5

 
(41
)
 
(112.2
)%
(3)
Total direct costs
66

 
284

 
(76.8
)%
 
858

 
435

 
97.2
 %
 
Indirect costs:
 
 
 
 
 
 
 

 
 

 
 

 
Compensation and related expense
158

 
525

 
(69.9
)%
 
635

 
1,052

 
(39.6
)%
(4)
Other indirect R&D costs
372

 
712

 
(47.8
)%
 
1,090

 
1,376

 
(20.8
)%
(5)
Total indirect costs
530

 
1,237

 
(57.2
)%
 
1,725

 
2,428

 
(29.0
)%
 
Total research and development expense
$
596

 
$
1,521

 
(60.8
)%
 
$
2,583

 
$
2,863

 
(9.8
)%
 

(1)
Costs for our FCX-007 program decreased approximately $0.2 million, or 86.2%, for the three months ended June 30, 2019 compared to the same period in 2018. The decrease for the three month period ended June 30, 2019 was due to the reclassification of the direct costs for this program under the CCP agreement, to cost of collaboration revenue.

Costs for our FCX-007 program increased approximately $.06 million, or 45%, for the six months ended June 30, 2019 compared to the same period in 2018. The increase for the six month period ended June 30, 2019 was primarily related to a $0.5 million purchase of viral vector material and a reduction of $0.5 million in costs related to the settlement of a dispute with a vendor recorded in 2018. All direct costs beginning April 12, 2019 are being reimbursed at 100% under the CCP agreement, and are recorded as part of cost of collaboration revenue.

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Through June 30, 2019 , we incurred approximately $26.8 million in direct research and development costs related to our FCX-007 program, life-to-date, which include non-cash expenses of $6.9 million in stock issuance costs associated with the 2012 ECC with Intrexon. Other costs include product and assay development, key opinion leader development, pre-clinical studies and manufacturing, the design of the Phase 1/2 clinical trial protocol and recruiting patients. Going forward, research and development investments for this program are expected to support clinical product manufacturing, statistical analyses, report generation and future clinical trial costs. Under the terms of the CCP Agreement, CCP will be responsible for the first $20 million in development costs prior to the initial BLA filing with the FDA and manufacturing costs undertaken prior to commercial launch of FCX-007. If such spending exceeds $20 million, CCP will be responsible for 70% of the excess costs and we will cover 30% of the remaining additional expenses.

(2)
Costs for our FCX-013 program decreased approximately $0.04 million, or 50%, for the three months ended June 30, 2019 compared to the same period in 2018. The decrease for the three month period ended June 30, 2019 was primarily related to an approximately $0.1 million decrease in costs from our clinical partner Intrexon, partially offset by an increase in purchases of lab supplies.

Costs for our FCX-013 program decreased approximately $0.3 million, or 79.7%, for the six months ended June 30, 2019 compared to the same period in 2018. The decrease for the six month period ended June 30, 2019 was primarily related to an approximately $0.2 million decrease in costs from our clinical partner Intrexon, and decreased costs for lab supplies and consulting expenses.

Through June 30, 2019 , we incurred approximately $14.4 million in direct research and development costs related to our FCX-013 program, life-to-date, which include non-cash expenses of $6.4 million in stock issuance costs with the 2012 ECC with Intrexon. Other costs include product and assay development and pre-clinical work, including execution of our proof-of concept and pre-clinical dose-ranging studies. Going forward, research and development investments for this program are expected to support ongoing product and assay development, pre-clinical study execution, key opinion leader development, National Institutes of Health Recombinant DNA Advisory Committee meeting preparation expenses, and the design and execution of clinical trials.

(3)
Other costs were not significant for the three and six months ended June 30, 2019 and 2018.

(4)
Compensation and other related expense decreased approximately $0.4 million, or 69.9%, due to the allocation of compensation being reimbursed under the CCP agreement to cost of collaboration revenue. Without this reduction, compensation and related expense increased approximately $0.1 million to $0.6 million, or 16% for the three months ended June 30, 2019 as compared to the three months ended June 30, 2018. This increase is primarily related to increased salary and bonus costs.

Compensation and other related expense decreased approximately $0.4 million, or 39.6%, for the reasons as described above. Without the reduction from the classification of some of these costs to cost of collaboration revenue, compensation and related expense were comparable for the six months ended June 30, 2019 and June 30, 2018 at approximately $1.1 million for each period.

(5)
Other indirect costs decreased approximately $0.4 million, or 50.1%, for the three months ended June 30, 2019, as compared to the same period in 2018. This decrease was primarily due to the allocation of certain of these costs being reimbursed under the CCP agreement to cost of collaboration revenue. Without this reduction other indirect costs increased 5.0% to approximately $0.8 million. This increase was the result primarily of increased costs for contract labor, lab supplies and facility & equipment repair and maintenance.

Other indirect costs decreased approximately $0.3 million, or 22.0%, for the six months ended June 30, 2019, as compared to the same period in 2018. This decrease was primarily due to the allocation of certain of these costs being reimbursed under the CCP agreement to cost of collaboration revenue. Without this reduction other indirect costs increased 6.5% to approximately $1.5 million. This increase was the result primarily of increased costs for contract labor, lab supplies and facility & equipment repair and maintenance.

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Selling, General and Administrative Expense
Selling, general and administrative expense was comprised of the following:
 
For the Three Months Ended June 30,
 
For the Six Months
Ended June 30,
 
($ in thousands)
2019

 
2018

 
% Change
 
2019
 
2018
 
% Change
 
Compensation and related expense
$
540

 
$
427

 
26.5
%
 
$
960

 
$
875

 
9.7
%
(1)
Professional fees
1,031

 
366

 
181.7
%
 
1,626

 
809

 
101.0
%
(2)
Facilities and related expense and other
885

 
763

 
16.0
%
 
1,740

 
1,511

 
15.2
%
(3)
Total selling, general and administrative expense
$
2,456

 
$
1,556

 
57.8
%
 
$
4,326

 
$
3,195

 
35.4
%
 

(1)
Compensation and related expense increased approximately $0.1 million, or 26.5% for the three months ended June 30, 2019 and 2018. This increase was related primarily to increased employee salary and bonus costs.

Compensation and related expense increased approximately $0.1 million, or 9.7% for the six months ended June 30, 2019 and 2018. This increase was related primarily to increased employee salary and bonus costs.

(2)
Professional fees increased approximately $0.7 million, or 181.7%, for the three months ended June 30, 2019 as compared to the same period in 2018. This increase was due primarily to increased consulting and legal fees related to the CCP Agreement.
Professional fees increased approximately $0.8 million, or 101.0%, for the six months ended June 30, 2019 as compared to the same period in 2018. This increase was due primarily to increased consulting and legal fees related to the CCP Agreement.
(3)
Facilities and related expense and other, increased approximately $0.1 million, or 15.9%, for the three months ended June 30, 2019 as compared to the three months ended June 30, 2018. This increase was due primarily to costs associated with new employee acquisition and increased insurance costs.
Facilities and related expense and other, increased approximately $0.2 million, or 15.1%, for the six months ended June 30, 2019 as compared to the six months ended June 30, 2018. This increase was due primarily to costs associated with new employee acquisition and increased insurance costs.
Warrant Revaluation Income (Expense)

During the three months ended June 30, 2019 and 2018 , we recorded non-cash income of approximately $0.04 million, and $0.1 million, respectively, for warrant revaluation charges in our Condensed Consolidated Statements of Operations. The primary reason for the significant change between the warrant revaluation charges noted above was due to the change in our stock price (from $1.93 to $1.90) during the three months ended June 30, 2019 as compared to the change (from $2.95 to $2.71) in our stock price during the three months ended June 30, 2018.
During the six months ended June 30, 2019 and 2018 , we recorded non-cash income of $0.01 million and $0.3 million, respectively, for warrant revaluation charges in our Condensed Consolidated Statements of Operations. The primary reason for the significant change between the warrant revaluation charges noted above was due to the change in our stock price (from $1.50 to $1.90) during the six months ended June 30, 2019 compared to the change (from $3.20 to $2.71) in our stock price during the six months ended June 30, 2018.    
Due to the nature and inputs of the model used to assess the fair value of our outstanding warrants, it is normal to experience significant fluctuations from period to period. These fluctuations are due to a variety of factors including changes in our stock price, changes in the remaining contractual life of the warrants, and changes in management's estimated probability of certain events occurring that would impact the warrants.




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Derivative Revaluation Income (Expense)

During the three months ended June 30, 2019 and 2018, we recorded non-cash derivative revaluation expense of approximately $1.1 million and non-cash derivative revaluation income of approximately $0.2 million, respectively, for derivative liability revaluation charges in our Condensed Consolidated Statements of Operations related to a compound bifurcated derivative initially recorded in September 2016 in connection with the private placement of an aggregate of $18,087,500 in principal of convertible promissory notes and accompanying warrants to purchase an aggregate of 1,205,840 shares of our common stock to institutional and accredited investors (the 2016 Private Placement). The primary reason for the significant change between the derivative revaluation charges noted above was due to a change in estimate of the probability of a change of control transaction.

During the six months ended June 30, 2019 and 2018, we recorded non-cash derivative revaluation expense of approximately $1.1 million and non-cash derivative revaluation income of approximately $0.2 million, respectively, for derivative liability revaluation charges in our Condensed Consolidated Statements of Operations related to a compound bifurcated derivative initially recorded in September 2016 in connection with the 2016 Private Placement. The primary reason for the significant change between the derivative revaluation charges noted above was due to a change in estimate of the probability of a change of control transaction.

    Due to the nature and inputs of the model used to assess the fair value of our compound bifurcated derivative, it is normal to experience significant fluctuations from period to period. These fluctuations are due to a variety of factors including changes in our stock price, changes in the remaining contractual life of the bifurcated derivative, and changes in management's estimated probability of certain events occurring that would impact the compound bifurcated derivatives.

Interest Expense

During the three months ended June 30, 2019 and 2018, we recorded interest expense of approximately $0.2 million for each period in our Condensed Consolidated Statements of Operations related to the convertible promissory notes that we issued in the 2016 Private Placement (the Convertible Notes) which bear interest at 4% per annum.

During the six months ended June 30, 2019 and 2018, we recorded interest expense of approximately $0.4 million for each period in our Condensed Consolidated Statements of Operations related to the Convertible Notes which bear interest at 4% per annum.
    
Other income, net
    
During the three months ended June 30, 2019 and 2018, we had other income of approximately $0.1 million and $0.04 million, respectively. This increase is due primarily to increased earnings on invested cash balances.

During the six months ended June 30, 2019 and 2018, we had other income of approximately $0.5 million and $0.1 million, respectively. This increase is due primarily to approximately $0.3 million in charges being reimbursed under the FDA grant we received in 2018.

Income taxes

During the three months ended June 30, 2019 , we had income tax expense of approximately $0.6 million. This is due to our effective rate estimated for the year to be approximately 7.23%. We did not record a tax expense for the three months ended June 30, 2018.

During the six months ended June 30, 2019, we had income tax expense of approximately $0.6 million. This is due to our effective rate estimated for the year to be approximately 7.23%. We did not record a tax expense for the six months ended June 30, 2018.
    
Net Income

Net income increased approximately $14.7 million to approximately $11.8 million for the three months ended June 30, 2019 , as compared to the $2.9 million loss for the three months ended June 30, 2018. The increase in net income was due primarily to an approximately $16.6 million increase in gross profits and an approximately $0.9 million decrease in research and development costs, and an approximately $0.1 million increase in other income, partially offset by an approximately $0.9

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million increase in selling, general and administrative expenses, an approximately $1.4 million increase in derivative revaluation expense and an approximately $0.6 million increase in income taxes all as described above.

Net income increased approximately $13.9 million to $8.1 million for the six months ended June 30, 2019, as compared to the approximately $5.8 million loss for the three months ended June 30, 2018. The increase in net income was due primarily to an approximately $16.6 million increase in gross profits and an approximately $0.3 million decrease in research and development costs and an approximately $0.3 million increase in other income, partially offset by an approximately $1.1 million increase in selling, general and administrative expenses, an approximately $1.6 million increase in derivative and warrant revaluation expense, and an approximately $0.6 million increase in income taxes all as described above.
    
Contractual Obligations

During the six months ended June 30, 2019, there have been no material changes to our contractual obligations outside the ordinary course of business from those specified in our 2018 Form 10-K.
Critical Accounting Policies

Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon our Condensed Consolidated Financial Statements, which have been prepared in conformity with U.S. generally accepted accounting principles (GAAP). Preparing financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Estimates are based on our historical operations, our future business plans and projected financial results, the terms of existing contracts, our observance of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. These estimates and assumptions are affected by the application of our accounting policies. Critical accounting policies and practices are both important to the portrayal of a company’s financial condition and results of operations, and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effects of matters that are inherently uncertain. Actual results could differ from such estimates due to changes in economic factors or other conditions that are outside the control of management.

Our summary of significant accounting policies is described in Note 3 to our Consolidated Financial Statements contained in our 2018 Form 10-K. However, please refer to Note 3 in the accompanying Notes to the Condensed Consolidated Financial Statements contained in this Form 10-Q for our new significant policy on revenue, and updated policies and estimates, if applicable, that could impact our results of operations, financial position, and cash flows.
Recently Issued Accounting Pronouncements
    
See Note 3 in the accompanying Notes to the Condensed Consolidated Financial Statements of this Form 10-Q for discussion on recently issued accounting pronouncements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
    
Not applicable.
Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures 
    
Our management, including our Chief Executive Officer (our principal executive officer and principal financial officer), have evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), as of the end of the period covered by this Form 10-Q. Based upon that evaluation, our Chief Executive Officer (our principal executive officer and principal financial officer) concluded that, as of June 30, 2019 , our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and (b) such information is accumulated and communicated to our management,

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including our Chief Executive Officer (our principal executive officer and principal financial officer), as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.




Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarterly period ended June 30, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 


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PART II. OTHER INFORMATION
Item 1. Legal Proceedings

We are not currently a party to any legal proceedings.

Item 1A. Risk Factors

You should carefully consider each of the risk factors set forth under the heading “Risk Factors” in our 2018 Form 10-K. The risk factor set forth below supplements those risk factors. The occurrence of any one or more of these risks could materially harm our business, operating results, financial condition and prospects. These risks and uncertainties could also cause actual results to differ materially and adversely from those expressed or implied by forward-looking statements that we make from time to time. Please see “Note Regarding Forward-Looking Statements” appearing at the beginning of this Form 10-Q.
The CCP Agreement is important to our business. If we or CCP fail to adequately perform under the CCP Agreement, or if we or CCP terminate the CCP Agreement, the development and commercialization of FCX-007 would be delayed or terminated and our business would be adversely affected.
The CCP Agreement is important to our business. Under the terms of the CCP Agreement, CCP will receive an exclusive license to commercialize FCX-007 in the United States. Under the terms of the CCP Agreement, CCP will be responsible for the first $20 million in development costs prior to the initial BLA filing with the FDA and manufacturing costs undertaken prior to commercial launch of FCX-007. If such spending exceeds $20 million, CCP will be responsible for 70% of the excess costs and we will cover 30% of the remaining additional expenses. We will maintain responsibility for the development (including pre-launch manufacturing) of FCX-007 through initial BLA approval of FCX-007, and CCP will be responsible for all post-approval development and commercialization activities for FCX-007. We will receive $2.5 million for the first patient enrolled in the Phase 3 clinical trial and $30 million upon BLA approval and commercial manufacturing readiness. We are also eligible to receive up to $75 million in sales milestones, consisting of $25 million upon the achievement of $250 million in cumulative FCX-007 net sales and an additional $50 million upon the achievement of $750 million in cumulative FCX-007 net sales. In addition, CCP will pay us a 30% share of the gross profits from FCX-007 sales.
Under the CCP Agreement, we are dependent upon CCP to successfully commercialize FCX-007 in the United States. We cannot directly control CCP’s commercialization activities or the resources it allocates to FCX-007. Our interests and CCP’s interests may differ or conflict from time to time, or we may disagree with CCP’s level of effort or resource allocation. CCP may internally prioritize FCX-007 differently than we do or it may not allocate sufficient resources to effectively or optimally commercialize FCX-007. If these events were to occur, our business would be adversely affected. CCP also may not be successful in its efforts to commercialize FCX-007, and we may never receive any additional milestone payments or any profit share payments from CCP.
CCP has the right to terminate the CCP Agreement at will upon 180 days’ prior written notice. CCP may also terminate the CCP Agreement at any time, upon 180 days’ prior written notice to us, in the event (i) CCP determines, in its reasonable discretion, that further development or commercialization of FCX-007 is not commercially viable or (ii) CCP determines that development or commercialization of FCX-007 must be terminated because of safety issues outside of CCP’s reasonable control. Either party may, subject to specified cure periods, terminate the CCP Agreement in the event of the other party’s uncured material breach, and either party may terminate the CCP Agreement under specified circumstances relating to the other party’s insolvency.
Termination of the CCP Agreement could cause significant delays in our product development and commercialization efforts that could prevent us from commercializing FCX-007, if approved, without first expanding our internal capabilities or entering into another agreement with a third party. Any alternative collaboration or license could also be on less favorable terms to us. In addition, under the CCP Agreement, CCP agreed to provide funding for certain clinical development activities. If the CCP Agreement were terminated, we would need to seek additional financing to support the research and development of FCX-007, which may not be available on commercially reasonable terms, if at all. If we are unable to obtain additional financing to support the continued development of FCX-007, we may need to discontinue our development efforts of FCX-007 and our other product candidates, which would have a materially adverse effect on our business.



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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Risk Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

Item 6.     Exhibits.

EXHIBIT NO.
 
IDENTIFICATION OF EXHIBIT
3.1
 
3.2
 
3.3
 
3.4
 
3.5
 
3.6
 
3.7
 
3.8
 
3.9
 
4.1
 
4.2
 
4.3
 
4.4
 
4.5
 

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4.6
 

4.7
 
4.8
 

4.9
 
4.10
 

10.1
 
10.2
 

10.3
 

10.4
 

10.5*†
 

*31
 
**32
 
101.INS
 
XBRL Instance Document. 
101.SCH
 
XBRL Taxonomy Extension Schema Document.
101.CAL
 
XBRL Taxonomy Extension Calculation Linkbase Document.
101.LAB
 
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
 
XBRL Taxonomy Extension Presentation Linkbase Document.
101.DEF
 
XBRL Taxonomy Extension Definition Linkbase Document.

 
*    Filed herewith
**     Furnished herewith
†     Certain exhibits of this Exhibit have been omitted pursuant to Item 601 (a)(5) of Regulation S-K. Fibrocell Science, Inc. agrees to furnish a copy of this Exhibit to the Securities and Exchange Commission on a confidential basis upon request.

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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
FIBROCELL SCIENCE, INC.
 
 
By:
/s/ John M. Maslowski
 
John M. Maslowski
 
President and Chief Executive Officer
 
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
 
 
Date:
August 14, 2019


58
Certain identified information has been excluded from this exhibit because it both (i) is not material and (ii) would be competitively harmful if publicly disclosed. Omissions are designated as [**] FIBROCELL SCIENCE, INC. AND CASTLE CREEK PHARMACEUTICALS, LLC CO-DEVELOPMENT AND LICENSE AGREEMENT April 12, 2019 US-DOCS\106669270.9


 
TABLE OF CONTENTS Page 1. DEFINITIONS ........................................................................................................................1 2. LICENSE GRANTS ..............................................................................................................13 2.1 License Grant to CCP ..........................................................................................13 2.2 Sublicense Rights. ................................................................................................13 2.3 Assignment of Assigned Contracts. ....................................................................14 2.4 Access to Fibrocell Know-How ...........................................................................14 2.5 No Implied Rights or Licenses ............................................................................15 2.6 Retained Rights ....................................................................................................15 3. GOVERNANCE ....................................................................................................................15 3.1 General ..................................................................................................................15 3.2 Joint Development Committee............................................................................15 3.3 Dissolution of the JDC .........................................................................................17 4. DEVELOPMENT PROGRAM ................................................................................................17 4.1 Project ...................................................................................................................17 4.2 Development Plan and Development Budget. ...................................................18 4.3 Technical Cooperation.........................................................................................19 4.4 Compliance with Applicable Laws .....................................................................19 4.5 Subcontracting Permitted. ..................................................................................19 5. REGULATORY MATTERS ...................................................................................................20 5.1 Pharmacovigilance Agreement ...........................................................................20 5.2 Preparation of Regulatory Filings. .....................................................................20 5.3 Notice of Communication with Regulatory Authorities. ..................................21 5.4 Regulatory Compliance .......................................................................................22 5.5 Regulatory Documentation .................................................................................22 5.6 BLA Transfer .......................................................................................................22 5.7 Product Recall ......................................................................................................22 5.8 Cooperation ..........................................................................................................22 5.9 Priority Review Voucher .....................................................................................23 5.10 Rights of Reference to Regulatory Materials ....................................................23 6. COMMERCIALIZATION ......................................................................................................23 6.1 Responsibility for Commercialization................................................................23 6.2 Packaging; CCP Trademarks .............................................................................23 7. MANUFACTURE AND SUPPLY OF PRODUCT ......................................................................23 US-DOCS\106669270.9


 
TABLE OF CONTENTS PAGE 7.1 Commercial Manufacturing ...............................................................................23 8. DILIGENCE .........................................................................................................................23 8.1 By Fibrocell...........................................................................................................23 8.2 By CCP ..................................................................................................................23 9. PAYMENT OBLIGATIONS ...................................................................................................24 9.1 Upfront Payment ..................................................................................................24 9.2 Development Cost Sharing ..................................................................................24 9.3 Profit Sharing .......................................................................................................25 9.4 Method and Timing of Payments .......................................................................25 9.5 Milestone Payments. ............................................................................................25 9.6 Disputed Payments...............................................................................................26 9.7 Currency of Payment ...........................................................................................26 9.8 Accounting. ...........................................................................................................26 9.9 Withholding Tax ..................................................................................................27 10. RECORD KEEPING, RECORD RETENTION AND AUDITS ....................................................27 10.1 Record Keeping ....................................................................................................27 10.2 Record Retention .................................................................................................28 10.3 Audit Request .......................................................................................................28 10.4 Survival .................................................................................................................28 11. INVENTIONS, KNOW-HOW AND PATENTS .........................................................................28 11.1 Existing Intellectual Property .............................................................................28 11.2 Ownership of Inventions. ....................................................................................28 11.3 Patent Prosecution and Maintenance.................................................................29 11.4 Third Party Licenses............................................................................................31 11.5 Infringement by Third Parties. ...........................................................................31 11.6 Infringement Outside the Field...........................................................................33 11.7 Further Actions ....................................................................................................33 11.8 Intrexon Patents ...................................................................................................33 11.9 Change of Control ................................................................................................33 12. TRADEMARKS ....................................................................................................................33 12.1 Product Trademark .............................................................................................33 12.2 Trademark Prosecution and Maintenance ........................................................33 13. REPRESENTATIONS, WARRANTIES AND COVENANTS ......................................................34 13.1 The Parties’ Representations and Warranties ..................................................34 13.2 Additional Representations and Warranties of Fibrocell ................................35 ii US-DOCS\106669270.9


 
TABLE OF CONTENTS PAGE 13.3 Covenants of the Parties ......................................................................................37 13.4 Covenants of Fibrocell .........................................................................................38 13.5 Covenant of CCP..................................................................................................39 14. MUTUAL INDEMNIFICATION AND INSURANCE ..................................................................39 14.1 Fibrocell’s Right to Indemnification ..................................................................39 14.2 CCP’s Right to Indemnification .........................................................................39 14.3 Process for Indemnification ................................................................................40 14.4 Insurance ..............................................................................................................41 15. LIMITATION OF LIABILITY AND EXCLUSION OF DAMAGES; DISCLAIMER OF WARRANTY ..................................................................................41 16. CONFIDENTIALITY .............................................................................................................41 16.1 Confidentiality; Exceptions .................................................................................41 16.2 Degree of Care; Permitted Use ...........................................................................42 16.3 Permitted Disclosures ..........................................................................................42 16.4 Irreparable Injury ...............................................................................................43 16.5 Return of Confidential Information ...................................................................43 16.6 Survival of Obligations ........................................................................................43 17. PUBLICITY .........................................................................................................................43 17.1 Public Disclosure ..................................................................................................43 17.2 Use of Marks .........................................................................................................44 18. TERM AND TERMINATION .................................................................................................44 18.1 Term ......................................................................................................................44 18.2 Termination by CCP............................................................................................44 18.3 Termination for Material Breach .......................................................................45 18.4 Termination upon Insolvency .............................................................................45 18.5 Termination by CCP pursuant to Section 18.2 or Fibrocell pursuant to Section 18.3 or 18.4. .........................................................................................45 18.6 Termination by CCP Pursuant to Section 18.3 or 18.4 ....................................47 18.7 General Surviving Obligations ...........................................................................48 18.8 Accrued Rights, Surviving Obligations..............................................................49 18.9 Rights in Bankruptcy ...........................................................................................49 19. MISCELLANEOUS ...............................................................................................................49 19.1 Agency ...................................................................................................................49 19.2 Assignment; Change of Control. ........................................................................49 19.3 Further Actions ....................................................................................................50 19.4 Force Majeure ......................................................................................................50 iii US-DOCS\106669270.9


 
TABLE OF CONTENTS PAGE 19.5 Notices ...................................................................................................................50 19.6 Amendment ..........................................................................................................51 19.7 Waiver ...................................................................................................................51 19.8 Counterparts ........................................................................................................51 19.9 Construction .........................................................................................................51 19.10 Governing Law .....................................................................................................51 19.11 Severability ...........................................................................................................51 19.12 Compliance with Applicable Law.......................................................................52 19.13 Entire Agreement of the Parties .........................................................................52 19.14 Performance by Affiliates. ...................................................................................52 19.15 Non-Solicitation ....................................................................................................52 iv US-DOCS\106669270.9


 
CO-DEVELOPMENT AND LICENSE AGREEMENT THIS CO-DEVELOPMENT AND LICENSE AGREEMENT (the “Agreement”) is made and entered into as of April 12, 2019 (the “Effective Date”) by and between FIBROCELL SCIENCE, INC., a Delaware corporation with a principal place of business at 405 Eagleview Blvd., Exton, Pennsylvania 19341 (“Fibrocell”), and CASTLE CREEK PHARMACEUTICALS, LLC, a Delaware limited liability company with a principal place of business at 6 Century Drive, Parsippany, New Jersey 07054 (“CCP”). Fibrocell and CCP are sometimes referred to herein individually as a “Party” and collectively as the “Parties”. Except as otherwise provided in Section 19.14, references to “Fibrocell” and “CCP” will not include their respective Affiliates. RECITALS WHEREAS, Fibrocell is a biotechnology company engaged in the research, development, and commercialization of pharmaceutical biologics for the amelioration, treatment and/or prevention of human diseases and conditions, including Recessive Dystrophic Epidermolysis Bullosa (“RDEB”); WHEREAS, CCP is a pharmaceutical company engaged in the research, development and commercialization of pharmaceutical compounds for the amelioration, treatment and/or prevention of human diseases and conditions; WHEREAS, Fibrocell has developed and is conducting clinical trials of its product known as FCX-007, which consists of an autologous dermal fibroblast genetically modified to express functional Type VII collagen (the “Product”); WHEREAS, CCP and Fibrocell desire to collaborate in certain activities to develop the Product for the treatment of RDEB; and WHEREAS, CCP desires to obtain, and Fibrocell is willing to grant to CCP, a license under Fibrocell’s proprietary technology to Exploit the Product, on the terms and conditions provided in this Agreement. AGREEMENT NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this Agreement and intending to be legally bound, the Parties agree as follows: 1. DEFINITIONS. As used herein, the following terms will have the following meanings: 1.1 “Acquired Party” has the meaning set forth in Section 11.9. 1.2 “Acquiror” has the meaning set forth in Section 11.9. 1.3 “Acquiror Affiliate” has the meaning set forth in Section 11.9. US-DOCS\106669270.9


 
1.4 “Affiliate” means a corporation, partnership, trust or other entity that directly, or indirectly through one or more intermediates, controls, is controlled by or is under common control with a specified Party. For such purposes, “control,” “controlled by” and “under common control with” will mean the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting equity, voting member or partnership interests, control of a majority of the board of directors or other similar body, by contract or otherwise. In the case of a corporation, the direct or indirect ownership of more than fifty percent (50%) of its outstanding voting shares or the ability otherwise to elect a majority of the board of directors or other managing authority of the entity will in any event be presumptively deemed to confer control, it being understood that the direct or indirect ownership of a lesser percentage of such shares will not necessarily preclude the existence of control. 1.5 “Agreement” has the meaning set forth in preamble hereto. 1.6 “Applicable Law” means all applicable laws, rules, and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities or other governmental authorities, that may be in effect from time to time in the Territory, including Health Care Laws. 1.7 “Assigned Contracts” means those contracts mutually agreed upon by the Parties. 1.8 “Assignment Date” has the meaning set forth in Section 2.3(b). 1.9 “Balancing Statement” has the meaning set forth in Section 9.4. 1.10 “Biosimilar Application” means an application or submission filed with a Regulatory Authority for marketing authorization of a Biosimilar Product. 1.11 “Biosimilar Product” means, with respect to the Product following Regulatory Approval in the applicable country, a biological product (a) that is “biosimilar” to or “interchangeable” with the Product, as the term “biosimilar” is defined in 42 U.S.C. § 262(i)(2) or 262(i)(3), as applicable, (b) for which Regulatory Approval is obtained in the Territory by referencing any regulatory materials of the Product, (c) that is approved for use in the Territory pursuant to a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. §§ 262, or any other similar provision that comes into force, or is the subject of a notice with respect to the Product under 42 U.S.C. § 262(l)(2), and (d) is sold in the Territory by any Third Party that is not a Sublicensee of CCP or its Affiliates under this Agreement and did not purchase the Product in a chain of distribution that included any of CCP or its Affiliates or Sublicensees. 1.12 “BPCIA” means Biologics Price Competition and Innovation Act of 2009, as amended. 1.13 “BLA” means a Biologics License Application for the Product under Section 351 of the Public Health Service Act, as may be amended, supplemented, or replaced, or any foreign equivalent thereto. 2 US-DOCS\106669270.9


 
1.14 “Breaching Party” has the meaning set forth in Section 18.3. 1.15 “CCP” has the meaning set forth in the preamble hereto. 1.16 “Change of Control” means, with respect to a Party, (a) the consummation of a merger or consolidation of such Party in which the shareholders of such Party that directly or indirectly control such Party immediately prior to such merger or consolidation do not continue to hold immediately following the closing of such merger or consolidation at least fifty percent (50%) of the combined voting power of the then outstanding securities of the surviving or resulting entity; (b) the consummation of a sale or transfer of all or substantially all of the assets of such Party to one or more Third Parties, or other similar transaction or series of related transactions; or (c) any transaction or series of transactions in which any person or entity or group of persons or entities acquires beneficial ownership of securities of a Party representing more than fifty percent (50%) of the combined voting power of the then outstanding securities of such Party; provided, however, that, notwithstanding subsections (a), (b) or (c) above, a sale of a Party’s securities in an underwritten public offering of such Party’s securities to multiple non-affiliated investors will not constitute a Change of Control. 1.17 “Clinical Trials” means Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials, Phase IV Clinical Trials (if applicable), and/or variations of such trials (e.g., Phase II/III) as those terms are defined by the FDA. 1.18 “CMC Data” means any and all Information contained in, as well as data supporting, the Chemistry, Manufacturing and Control sections (or sections corresponding thereto) of a BLA or other equivalent regulatory filing relating to the Product. 1.19 “Commencement” or “Commence” means, when used with respect to Clinical Trials (or the local equivalent), the date of enrollment of the first patient or subject in such Clinical Trials (or the local equivalent). 1.20 “Commercialization” means all activities undertaken relating to the manufacture for commercial use, marketing, and/or sale of the Product, including advertising, education, planning, marketing, promotion, distribution, market and product support, and will include post-Commercial Launch research, development, and medical activities such as Phase IV Clinical Trials but will exclude other Development activities. “Commercialize” will have a corresponding meaning. 1.21 “Commercial Launch” means the first arm’s length commercial sale of the Product by CCP or its Affiliate or Sublicensee to a Third Party (including any final sale to a distributor or wholesaler under any non-conditional sale arrangement) in a country where Regulatory Approval of the Product has been obtained; provided, however, that in no event will any sale or distribution of the Product for Pre-Launch Activities or use in a Clinical Trial be deemed a Commercial Launch. 1.22 “Commercially Reasonable Efforts” means (a) with respect to the efforts to be expended by a Party with respect to an agreed objective, except as otherwise 3 US-DOCS\106669270.9


 
provided in clause (b), such reasonable, diligent, and good faith efforts as such Party would normally use to accomplish a similar objective under similar circumstances taking into account the responsible allocation of such Party’s resources under the circumstances, but no less than the level of efforts and resources (including the promptness with which such efforts and resources would be applied) commonly used in the pharmaceutical industry with respect to a product of similar commercial potential at a similar stage in its development or product life by a party of the same or similar size as the Party, and with the same or similar resources as the Party, to achieve that applicable objective, and (b)(i) with respect to CCP’s obligations relating to the Commercialization of the Product under this Agreement, the efforts and resources normally used by a company in the biopharmaceutical industry of similar size and resources as CCP for a product that is of similar market potential at a similar stage in its product life, taking into account all relevant factors, including the responsible allocation of such company’s resources under the circumstances, the potential profitability of the Product, the costs and risks of Developing, Manufacturing, and Commercializing the Product, scientific, safety, efficacy and regulatory concerns, product profile, the competitiveness of the marketplace, regulatory exclusivity, the likelihood of regulatory approval given the regulatory structure involved, performance of other products that are of similar market potential and the likely timing of other products’ entry into the market, the patent protection and other proprietary position of the Product, relevant Third Party intellectual property necessary to Develop and Commercialize the Product, and other relevant factors commonly considered in similar circumstances, but not taking into account a competitive product in CCP’s portfolio, and (ii) with respect to Fibrocell’s obligations relating to the Development or Manufacturing of the Product under this Agreement, means efforts that are not less than those discovery, research, Development or Manufacturing efforts normally used by a company in the biopharmaceutical industry of similar size and resources as Fibrocell (including for purposes of such calculation, the financial resources afforded to Fibrocell as a result of CCP’s payments hereunder). For the avoidance of doubt, where a Party has an obligation to use Commercially Reasonable Efforts, the efforts of such Party and its Affiliates and Sublicensees will be considered in determining whether such Party has satisfied such obligation. 1.23 “Confidential Disclosure Agreement” has the meaning set forth in Section 16.1. 1.24 “Confidential Information” has the meaning set forth in Section 16.1. 1.25 “Control” means, with respect to any item of Information, Patent, Patent Application, know-how or other intellectual property right, the right to grant a license or sublicense with respect thereto as provided for in this Agreement, without violating the terms of any agreement or other arrangement with, or any legal rights of any Third Party. 1.26 “Cost Overruns” has the meaning set forth in Section 9.2. 1.27 “Damages” has the meaning set forth in Section 14.1. 1.28 “Debarred or Excluded” has the meaning set forth in Section 13.1(g). 1.29 “Develop” or “Development” means all activities relating to obtaining Regulatory Approval of the Product and all manufacturing activities undertaken prior to 4 US-DOCS\106669270.9


 
Commercialization (including those activities reasonably required for the scale up of Manufacturing processes or equipment in preparation for commercial supply of Product). This includes, for example, (a) preclinical testing, toxicology, formulation, clinical studies, including Clinical Trials, and regulatory affairs, and (b) manufacturing process development for bulk and finished forms of the Product, as applicable, production of clinical supply of Product, and manufacturing and quality assurance technical support activities. 1.30 “Development Budget” has the meaning set forth in Section 4.2(a). 1.31 “Development Costs” means the costs and expenses incurred by a Party or for its account after the Effective Date that are consistent with the approved Development Plan and are specifically attributable to the Development of the Product, and, in the case of Fibrocell, including the Intrexon Obligations, but excluding any royalties, milestones, sublicense income, reimbursements or other payments due to Intrexon under the Intrexon Agreement. 1.32 “Development Plan” has the meaning set forth in Section 4.2(a). 1.33 “Dollar” means a U.S. dollar, and “$” will be interpreted accordingly. 1.34 “Effective Date” has the meaning set forth in the preamble hereto. 1.35 “Excess Initial Development Costs” has the meaning set forth in Section 9.2. 1.36 “Executives” has the meaning set forth in Section 3.2(d). 1.37 “Exploit” or “Exploitation” means the making, having made, using, having used, selling, having sold, offering for sale and/or otherwise disposing of, the Product, including all discovery, research, Development (including the conduct of Clinical Trials), registration, modification, enhancement, improvement, manufacturing, labeling, storage, formulation, exportation, importation, optimization, transportation, distribution, promotion, marketing and Commercialization activities related thereto. 1.38 “FDA” means the United States Food and Drug Administration, or any successor thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products in the United States. 1.39 “FDCA” has the meaning set forth in Section 1.51. 1.40 “Fibrocell” has the meaning set forth in the preamble hereto. 1.41 “Fibrocell Know-How” means all Information (a) listed in Exhibit 1.41 or (b) that is (i) Controlled by Fibrocell or its Affiliates as of the Effective Date or at any time during the term of this Agreement and (ii) used with, incorporated or included in, or otherwise necessary for the Exploitation of, the Product in the Field in the Territory. Fibrocell Know-How includes the Intrexon Confidential Information, Intrexon Know-How, Intrexon Materials (as those terms are defined in the Intrexon Agreement) and any other Information licensed or disclosed to Fibrocell under the Intrexon Agreement. Fibrocell Know-How includes Fibrocell’s 5 US-DOCS\106669270.9


 
or its Affiliates’ interest in unpublished Inventions and unpublished Joint Inventions. Fibrocell Know-How does not include Fibrocell Patent Rights. 1.42 “Fibrocell Patent Rights” means (a) the Patents listed in Exhibit 1.42, (b) any Patents that issue from the Patent Applications listed in Exhibit 1.42, (c) any Patents and/or Patent Applications that claim priority to a Patent or Patent Application listed in Exhibit 1.42, including any continuation, continued prosecution application, divisional, reissue or re- examination, (d) any other Patent and/or Patent Application that is Controlled by Fibrocell or its Affiliates as of the Effective Date or at any time during the term of this Agreement and that claims the Product or any other product, method, apparatus, material, manufacturing process or other technology that is necessary to Exploit the Product in the Field in the Territory, and (e) any foreign equivalents of the Patents and/or Patent Applications referenced in Section 1.42(a), (b), (c) or (d). Fibrocell Patent Rights include the Patents and Patent Applications licensed to Fibrocell under the Intrexon Agreement. Fibrocell Patent Rights includes Fibrocell’s interest in Joint Patent Rights. Fibrocell Patent Rights do not include Fibrocell Know-How. 1.43 “Field” means the amelioration, treatment and/or prevention of any and all diseases and conditions. 1.44 “Force Majeure Event” has the meaning set forth in Section 19.4. 1.45 “Fully Burdened Manufacturing Costs” has the meaning set forth in Exhibit 1.45. 1.46 “GAAP” means United States generally accepted accounting principles consistently applied. 1.47 “General Disclosure” has the meaning set forth in Section 17.1. 1.48 “Good Clinical Practices” or “GCP” means the then current standards, practices and procedures set forth in the guidelines entitled in “Good Clinical Practice: Consolidated Guideline,” including related regulatory requirements imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the Territory. 1.49 “Good Laboratory Practices” or “GLP” means the then current regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the Territory. 1.50 “Good Manufacturing Practices” or “GMP” means the then current regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA, and, as applicable, any similar or equivalent regulations and requirements in jurisdictions outside the Territory. 1.51 “Health Care Laws” means, as applicable: (a) the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7, 1320a-7a, and 1320a-7b of Title 42 of the United States Code 6 US-DOCS\106669270.9


 
and the regulations promulgated pursuant to such statutes and any comparable self-referral or fraud and abuse laws promulgated by any state; (b) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder (“HIPAA”) and any law or regulation the purpose of which is to protect the privacy of individually-identifiable patient information; (c) Medicare (Title XVIII of the Social Security Act); (d) Medicaid (Title XIX of the Social Security Act); (e) Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010; (f) the Federal Food, Drug and Cosmetic Act (the “FDCA”), the Public Health Service Act (the “PHSA”) and FDA regulations promulgated thereunder; (g) the Sunshine/Open Payments Law (42 U.S.C. § 1320a-7h); and (h) any other requirements of law applicable to a Party’s (i) design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, advertising, distributing, selling, pricing, or marketing of biologics, (ii) remuneration (including ownership) to or by physicians or other health care providers (including kickbacks) or the disclosure or reporting of the same, (iii) patient or program charges, record-keeping, claims processing, documentation requirements, medical necessity, referrals, (iv) hiring of employees (excluding general employment laws and practices), (v) acquisition of services or supplies from those who have been excluded from government health care programs, (vi) quality, safety, privacy, security, licensure, accreditation activities or (vii) any other aspect of providing health care products or services, including the collection and reporting requirements and the processing of any applicable rebate, chargeback or adjustment. 1.52 “HIPAA” has the meaning set forth in Section 1.51. 1.53 “IND” means an Investigational New Drug application for the Product, which must be approved by the FDA (or foreign equivalent) before shipment of the Product intended for administration to humans. 1.54 “Indemnified Party” has the meaning set forth in Section 14.3(a). 1.55 “Indemnifying Party” has the meaning set forth in Section 14.3(a). 1.56 “Information” means ideas, inventions, discoveries, concepts, formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, technology, designs, drawings, computer programs, skill, experience, documents, apparatus, results, clinical and regulatory strategies, test data, including pharmacological, toxicological and clinical data, analytical and quality control data, manufacturing data and descriptions, Patent and legal data, market data, financial data or descriptions, devices, assays, chemical formulations, specifications, compositions of matter, product samples and other samples, physical, chemical and biological materials and compounds, and the like, in written, electronic or other form, now known or hereafter developed, whether or not patentable. 1.57 “Initial BLA Approval” has the meaning set forth in Section 9.2. 1.58 “Initial Cost Cap” has the meaning set forth in Section 9.2. 7 US-DOCS\106669270.9


 
1.59 “Initial Development Costs” has the meaning set forth in Section 9.2. 1.60 “Initial Indication” means the amelioration, treatment and/or prevention of RDEB. 1.61 “Initial Public Disclosure” has the meaning set forth in Section 17.1. 1.62 “Intrexon” means Intrexon Corporation. 1.63 “Intrexon Agreement” means that certain Exclusive Channel Collaboration Agreement by and between Fibrocell and Intrexon, effective as of October 5, 2012, as amended by that certain First Amendment to Exclusive Channel Collaboration Agreement, dated June 28, 2013, that certain Second Amendment to Exclusive Channel Collaboration Agreement, dated January 10, 2014, and that certain letter agreement dated September 29, 2015, and as further amended from time to time. 1.64 “Intrexon Obligations” means amounts due to Intrexon pursuant to and in accordance with Section 4.7 of the Intrexon Agreement in consideration for the research and development support services performed by Intrexon for Fibrocell thereunder, to the extent such amounts due are (a) approved by CCP in advance and in writing, (b) directly and exclusively related to the Development of the Product in the Field and in the Territory, and (c) incurred in connection with such services performed after the Effective Date. 1.65 “Intrexon Rights” has the meaning set forth in Section 13.4(b). 1.66 “Inventions” has the meaning set forth in Section 11.2(a). 1.67 “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.1. 1.68 “Joint Inventions” has the meaning set forth in Section 11.2(a). 1.69 “Joint Patent Rights” has the meaning set forth in Section 11.3(a)(iii). 1.70 “KOL” means key opinion leader. 1.71 “Manufacture” or “Manufacturing” means the activities to be performed by Fibrocell or CCP in connection with the manufacture, testing (including quality control, quality assurance and lot release testing), bulk packaging and/or storage of the Product, as applicable. 1.72 “Manufacturing and Supply Agreement” has the meaning set forth in Section 7.1. 1.73 “Milestone Payments” has the meaning set forth in Section 9.5(a). 8 US-DOCS\106669270.9


 
1.74 “Net Sales” means the gross amount received by CCP, its Affiliates or Sublicensees from Third Parties for sales of the Product in the Territory, less (solely to the extent related to the Product): (a) sales returns and allowances, including trade, quantity and cash discounts and any other adjustments, including those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates, recalls, replacements, uncollectible amounts due, chargeback rebates, fees, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, healthcare insurance carriers or other institutions, managed health care organizations, pharmacy benefit managers (or equivalents thereof), national, state/provincial, local, and other governments, their agencies and purchasers and reimbursers, or to trade customers (managed care and similar types of rebates and chargebacks) or inventory writeoffs, (b) accrued allowances for normal and customary trade, quantity and cash discounts, (c) all of the following actually invoiced to the Third Party: freight, transportation, insurance, handling, packing and distribution charges, (d) inventory management fees or similar fees for bona fide services provided by wholesalers, distributors, warehousing chains and other Third Parties related to the distribution of the Product, (e) the actual loss experienced in respect of bad debts written off, (f) customs or excise taxes including import duties and other duties relating to sales, or other governmental charges (including any tax such as a value added or similar tax, other than any taxes based on income) relating to the sale of the Product, (g) any payment in respect to sales to any governmental authority in respect of any government subsidized program, including Medicare and Medicaid rebates, (h) the annual fee on prescription drug manufacturers imposed by the United States Patient Protection and Affordable Care Act, and (i) any item substantially similar in character and/or substance to the above, all as determined in accordance with GAAP on a basis consistent with CCP’s annual audited financial statements, and any other deductions not otherwise itemized above but which are hereinafter consistently applied across CCP’s products as a result of a change in Applicable Law or GAAP. In addition, Net Sales by CCP hereunder are subject to the following: (1) Any transfer, sale or other disposal of the Product by CCP to an Affiliate of CCP will not be included in Net Sales if that Affiliate is not an end-user of the Product; in such case, Net Sales will be calculated as above on the value charged or invoiced on the first arm’s length sale to a Third Party; 9 US-DOCS\106669270.9


 
(2) Use of the Product in Clinical Trials or pre-clinical trials or other research or development activities (including pursuant to an Expanded Access Program) or disposal of the Product for non-profit purposes of a commercially reasonable program (including, pursuant to patient assistance, indigent care, compassionate use, free goods and similar programs) will not give rise to any deemed sale for purposes of this definition, unless the Product is sold or disposed of for a profit; (3) In the event that the Product is Commercialized in combination with one or more products which are themselves not the Product under this Agreement for a single price, the Net Sales for the Product will be calculated by multiplying the sales price of such combination sale by the fraction A/(A+B) where A is the fair market value of the Product and B is the fair market value of the other product(s) in the combination sale. If the fair market value for any product sold in combination with the Product cannot be reasonably determined, the price attributed to such product will be based on the relative cost of goods for such product, as determined in accordance with GAAP. In addition, in the event that the Product is sold with any other product(s) or if any giveaways, discounts, rebates or charge-backs (whether as part of a customer loyalty, bundling or “loss leader” program, or otherwise) are provided for the Product to promote or sell other products or otherwise, the Net Sales for the Product will be no less than the fair market value of the Product on a stand-alone basis (excluding any such discounts, rebates or charge-backs); and (4) Notwithstanding anything to contrary contained herein, the following will not be considered Net Sales for purposes of this Agreement: sales of (x) a Biosimilar Product by any Sublicensee that has received a royalty-free license from CCP in settlement of any dispute or pursuant to any judgment (provided that any amounts received in settlement of an infringement claim will be treated in accordance with Section 11.5(a)), (y) the Product or a Biosimilar Product by a compulsory Sublicensee pursuant to a royalty-free license or sublicense granted to a Third Party through the order, decree or grant of a governmental authority having competent jurisdiction, authorizing such Third Party to Manufacture, use, sell, offer for sale, import or export the Product in the Territory, or (z) the Product as to which CCP does not receive any consideration tied to sales of the Product. If CCP appoints a distributor to sell an authorized Biosimilar Product of the Product, then only the consideration actually paid to CCP by such distributor will be included in the calculation of Net Sales. 1.75 “Non-Breaching Party” has the meaning set forth in Section 18.3. 1.76 “Non-Publishing Party” has the meaning set forth in Section 17.1. 1.77 “Party” or “Parties” has the meaning set forth in the preamble hereto. 1.78 “Patent” means (a) letters patent (or other equivalent legal instrument), including utility and design patents, and including any extension, substitution, registration, confirmation, reissue, re-examination or renewal thereof and (b) all foreign or international equivalents of any of the foregoing in any country in the Territory. 1.79 “Patent Application” means (a) an application for letters patent, including a reissue application, a re-examination application, a continuation application, a 10 US-DOCS\106669270.9


 
continued prosecution application, a continuation-in-part application, a divisional application or any equivalent thereof that is pending at any time during the term of this Agreement before a government Patent agency and (b) all foreign or international equivalents of any of the foregoing in any country in the Territory. 1.80 “Pharmacovigilance Agreement” has the meaning set forth in Section 5.1. 1.81 “Phase I Clinical Trial” means any clinical study conducted on sufficient numbers of human subjects to establish the safety of the Product over a range of doses, as more fully defined in 21 C.F.R. § 312.21(a), or its successor regulation. 1.82 “Phase II Clinical Trial” means any clinical study conducted on sufficient numbers of human subjects for an indication, to establish the safety and efficacy of the Product for such indication in a target patient population over a dosage range, as more fully defined in 21 C.F.R. § 312.21(b), or its successor regulation. 1.83 “Phase III Clinical Trial” means any clinical study intended as a pivotal study for purposes of seeking Regulatory Approval that is conducted on sufficient numbers of human subjects to establish that the Product is safe and efficacious for its intended use, to define warnings, precautions, and adverse reactions that are associated with the Product in the dosage range to be prescribed, and to support Regulatory Approval of the Product or label expansion of such pharmaceutical product, as more fully defined in 21 C.F.R. § 312.21(c), or its successor regulation. 1.84 “Phase IV Clinical Trial” means clinical study of the Product on human subjects commenced after receipt of Regulatory Approval of the Product for the purpose of satisfying a condition imposed by a Regulatory Authority to obtain Regulatory Approval, or to support the marketing of such pharmaceutical product, and not for the purpose of obtaining initial Regulatory Approval of the Product. 1.85 “PHSA” has the meaning set forth in Section 1.51. 1.86 “Pre-Launch Activities” means all Commercialization activities undertaken with respect to the Product in the Territory prior to Commercial Launch and in preparation for the launch of the Product in the Territory. Pre-Launch Activities will include advertising, education, product-related public relations, health care economic studies, governmental affairs activities for reimbursement and formulary acceptance, sales force training, and other activities as determined by CCP in its sole discretion that are to be conducted in the Territory prior to the Commercial Launch of the Product. 1.87 “Product” has the meaning set forth in the recitals hereto. 1.88 “Product Gross Profit” means Net Sales less Fully Burdened Manufacturing Costs and any amounts paid for Third Party licenses pursuant to Section 11.4. Notwithstanding the foregoing, Product Gross Profit shall never be less than zero dollars ($0). 1.89 “Product Patents” has the meaning set forth in Section 11.3(a)(i). 11 US-DOCS\106669270.9


 
1.90 “Rare Pediatric Disease Priority Review Voucher” means a priority review voucher issued by the FDA or otherwise under the authority of the United States Department of Health and Human Services to Fibrocell (or its Affiliate(s)) as the sponsor of a rare pediatric disease product application related to the Product, that entitles the holder of such voucher to priority review of a single human drug application submitted under Section 505(b)(1) or 505(b)(2) of the FDCA or Section 351(a) of the United States Public Health Service Act, as further defined in the FDCA, or any successor or similar voucher under any successor statute. 1.91 “RDEB” has the meaning set forth in the recitals hereto. 1.92 “Regulatory Approval” means, with respect to the Product, approval by the FDA of a BLA or other applicable filing and satisfaction of related applicable FDA registration and notification requirements with respect to the Product. 1.93 “Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, including the FDA, regulating or otherwise exercising authority with respect to the Exploitation of the Product in the Territory. 1.94 “Regulatory Plan” has the meaning set forth in Section 5.2. 1.95 “Representing Party” has the meaning set forth in Section 13.1. 1.96 “Sublicense” means any agreement entered into by CCP and any person or entity, including Affiliates of CCP, granting such person or entity rights under any Fibrocell Patent Rights or Fibrocell Know-How, as the case may be, including grants of covenants not to sue and options to obtain licenses and/or sublicenses. 1.97 “Sublicensee” means any person or entity, including Affiliates of CCP, to which CCP grants a Sublicense under this Agreement. 1.98 “Territory” means the United States of America and its territories, commonwealths and protectorates (including Puerto Rico and Guam). 1.99 “Third Party” means any person or entity other than CCP, Fibrocell, or an Affiliate of either of them. 1.100 “Trademark” means any word, name, symbol, color, designation or device or any combination thereof, whether registered or unregistered, including any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo or business symbol. 1.101 “Valid Claim” means, for a country, a claim of an unexpired issued Patent or a pending Patent Application filed and kept pending in good faith, where either or both (a) such Patent or Patent Application is included in either the Patents or Patent Applications licensed to CCP under this Agreement, or (b) such claim directed to an Invention made solely or jointly by Fibrocell (whether or not assigned to CCP pursuant to Article 11) that in the absence of ownership thereof or a license thereto, would be infringed by the Exploitation of the Product 12 US-DOCS\106669270.9


 
and that has not been (i) cancelled with prejudice, (ii) withdrawn from consideration without the ability to submit or refile, (iii) finally determined to be unallowable by the applicable governmental authority (and from which no appeal is or can be taken), (iv) finally determined to be invalid or unenforceable by a court of competent jurisdiction, (v) disclaimed, or (vi) abandoned. For purposes hereof, a claim in a Patent Application that has not been granted before the later to occur of (A) the date that is seven (7) years after its earliest effective priority date in a given country, or (B) the date of Commercial Launch in such country, will not be considered to be a Valid Claim unless and until it is granted. 2. LICENSE GRANTS 2.1 License Grant to CCP. On the terms and subject to the conditions of this Agreement, including the payment obligations under Article 9, Fibrocell, on behalf of itself and its Affiliates, hereby grants to CCP, effective upon the Effective Date, an exclusive (even as to Fibrocell and its Affiliates) license with the right to grant sublicenses in accordance with Section 2.2, under the Fibrocell Know-How and Fibrocell Patent Rights, to Exploit the Product in the Field in or for the Territory, provided that the foregoing license is subject to Fibrocell’s rights to Develop the Product as set forth in Article 4 and Manufacture the Product as set forth in Article 7. 2.2 Sublicense Rights. (a) CCP will have the right to grant written Sublicenses, through multiple tiers, under the rights granted to it under Section 2.1 to any of its Affiliates and Third Parties. CCP’s right to grant such Sublicenses will be subject to the following: (a) each Sublicensee will agree to be bound by all of the applicable terms and conditions of this Agreement; (b) the terms of each Sublicense granted by CCP will provide that the Sublicensee will be subject to the terms and conditions of this Agreement; (c) CCP’s grant of any Sublicense will not relieve CCP from any of its obligations under this Agreement; (d) CCP will notify Fibrocell of the identity of any Sublicensee promptly after entering into any Sublicense and provide Fibrocell with a copy of the Sublicense, provided that CCP may redact such copy at its discretion to remove information that is not relevant to this Agreement; and (e) the Sublicense must be in writing. (b) Unless a Sublicense provides that it will terminate upon termination of this Agreement, if this Agreement terminates for any reason other than termination by CCP pursuant to Section 18.2(a), then at the option of any Sublicensee not in material breach of the applicable Sublicense such Sublicensee will, from the effective date of such termination, become a direct licensee of Fibrocell under, and subject to the terms and conditions of, this Agreement, subject to modifications to the Sublicense with respect to territory, field and exclusivity consistent with the scope of this Agreement and so as to accommodate all such Sublicensees; provided, however, that such Sublicensee promptly cures all material breaches by CCP of this Agreement; and provided further that Fibrocell (i) will not have under any such direct license any obligations that are greater than or inconsistent with the obligations of Fibrocell under this Agreement or any fewer rights than it has under this Agreement, and (ii) Fibrocell will have no liability for any obligations arising prior to effective date of such direct 13 US-DOCS\106669270.9


 
license or for any obligations of CCP whenever arising and Fibrocell will be released from any and all liability relating to such obligations. 2.3 Assignment of Assigned Contracts. (a) Promptly following the Effective Date, the Parties will discuss and agree on which contracts that Fibrocell is a party to will be deemed Assigned Contracts. Fibrocell agrees to assign, and hereby assigns (to the extent permitted by the terms of such Assigned Contract), (i) as promptly as reasonably possible following the date of determination, all Assigned Contracts identified pursuant to the first sentence of this section, and (ii) from time to time after the Effective Date, all other Assigned Contracts as mutually agreed by the Parties. (b) In the event that (i) the assignment of the Assigned Contracts or any claim, right or benefit arising thereunder or resulting therefrom, without the consent of any Third Party, would constitute a breach or other contravention thereof, be ineffective with respect to any party thereto, or in any way adversely affect the claims, rights or benefits of CCP thereunder, and (ii) Fibrocell shall not have received the consent or approval of such Third Party prior to the proposed date of such assignment pursuant to Section 2.3(a) (such date, the “Assignment Date”), at the request of and for the benefit of CCP as to a particular Assigned Contract, Fibrocell and CCP shall use good faith efforts to obtain the consent or approval of any such Third Party to the assignment of such Assigned Contract or any claims, rights or benefits arising thereunder for the assignment thereof to CCP. Until such consent or approval is obtained, at the request of and for the benefit of CCP as to a particular Assigned Contract, Fibrocell will cooperate with CCP to enter into a mutually agreeable arrangement under which (A) CCP would obtain, to the maximum extent possible, the claims, rights and benefits under each such Assigned Contract (to the extent such claims, rights or benefits constitute Assigned Contract), (B) CCP would (i) assume, to the extent possible, all obligations of Fibrocell with respect to each such Assigned Contract arising on or after the Assignment Date and indemnify CCP in connection therewith and (ii) promptly pay to Fibrocell any amounts accruing under such Assigned Contract on or after the Assignment Date that are required to be paid by Fibrocell, and actually paid to a Third Party. At the request of and for the benefit of CCP as to a particular Assigned Contract, Fibrocell shall continue to use reasonable commercial efforts to obtain all such required consents and approvals, it being understood that upon receipt of all required consents and approvals for the assignment of an Assigned Contract (or any claim, right or benefit arising thereunder or resulting therefrom) to CCP, the assignment of such Assigned Contract shall be deemed to be effective as of the Assignment Date. Fibrocell will promptly pay to CCP, when received, all monies received under any Assigned Contract, or any claim, right or benefit arising thereunder, not assigned or transferred to the CCP on the Assignment Date. 2.4 Access to Fibrocell Know-How. Promptly after the Effective Date, Fibrocell will, at its sole expense, make available to CCP copies of the Fibrocell Know-How set forth on Exhibit 1.41. On a quarterly basis during the term of this Agreement, Fibrocell will, at its sole expense, make available to CCP any new material Fibrocell Know-How generated by or on behalf of Fibrocell of which Fibrocell is aware. For the sake of clarity, the transfer of Fibrocell Know-How contemplated by this Section 2.4 is intended to be documentary only, and is not intended to include any services by, or on behalf of Fibrocell. 14 US-DOCS\106669270.9


 
2.5 No Implied Rights or Licenses. Neither Party grants to the other Party any rights or licenses in or to any Patent or other intellectual property right, whether by implication, estoppel or otherwise, except to the extent expressly provided for under this Agreement. 2.6 Retained Rights. Except as set forth herein, Fibrocell retains for itself, its Affiliates and future licenses any and all rights under the Fibrocell Know-How and Fibrocell Patent Rights to Exploit products and services other than the Product in the Field and in the Territory. 3. GOVERNANCE 3.1 General. Promptly after the Effective Date, the Parties will establish a joint development committee (the “Joint Development Committee” or “JDC”) in accordance with Section 3.2(a) to oversee the Parties’ Development activities under this Agreement, including the financial and budgetary aspects thereof. The JDC may establish subcommittees, by unanimous agreement, to monitor and direct the Parties’ Development activities under this Agreement, including, by way of example, a CMC subcommittee, a clinical supply subcommittee, a regulatory subcommittee, or a finance subcommittee. The JDC will have the responsibilities and authority allocated to it in this Article 3 and elsewhere in this Agreement, and will make decisions consistent with the goal of implementing the Development Plan and conducting other activities under this Agreement in a manner consistent with the optimization of Product Development and Commercialization. The representatives of each Party on the JDC and any subcommittee will be responsible for ensuring that their decisions and actions are consistent with the views of, and have been approved by, the Party that appointed them. 3.2 Joint Development Committee. (a) Composition. Each Party will appoint two (2) of its senior employees to serve on the JDC or any subcommittee thereof, it being understood that each Party shall always have an equal number of representatives appointed to the JDC, or any subcommittee. CCP’s initial JDC representatives will be Timothy M. Cunniff and Ronald Ritz. Fibrocell’s initial JDC representatives will be Sean Buckley and Anna Malyala. The chairperson of the JDC and each subcommittee will alternate annually between the Parties. The initial JDC chairperson will be appointed by CCP. Each Party may replace its JDC representatives (including the chairperson appointee) by written notice to the other Party. (b) Responsibilities. The JDC will oversee and monitor the direction and course of the Development activities to be conducted hereunder. Without limiting the generality of the foregoing, the JDC will: (i) review, provide comment on, and approve Development Plans and related Development Budget, adjustments and updates thereto proposed by a Party, including through such Party’s representatives on the JDC, from time to time as it deems appropriate; (ii) review the Development activities and obligations of the Parties and the subcommittees under this Agreement; (iii) resolve any Development-related disputes or disagreements submitted to it by the Parties’ representatives thereto or by the subcommittees, as further described in Section 3.2(d); (iv) review all material data arising in the course of Development activities conducted pursuant to this Agreement by either Party; (v) review and 15 US-DOCS\106669270.9


 
discuss the preparation of regulatory filings for the Product, including new IND filings, applications for Regulatory Approval, and supportive filings with Regulatory Authorities; (vi) discuss the Development of label expansions, new dosage forms, formulations, or other new developments; (vii) appoint subcommittees as it deems appropriate for carrying out its responsibilities hereunder; (viii) perform such other Development-related oversight and monitoring functions as appropriate to further the purposes of this Agreement as determined by the Parties, including the periodic evaluation of performance against goals; and (ix) designate policies and procedures for the Parties’ reporting and calculation of Product Gross Profit and other financial terms set forth in this Agreement, and approve all variances from the applicable Development Budget in accordance with Section 9.2. (c) Meetings and Voting. The JDC will meet at least once per calendar quarter at times mutually agreed upon by the Parties until Commercial Launch of the Product for the Initial Indication, after which time the frequency of such meetings may be as otherwise agreed by the Parties. At least two (2) such meetings per calendar year must be held in person, and all other such meetings may be held by teleconference or videoconference. The location of the meetings of the JDC to be held in person will alternate between sites designated by each Party, with each meeting held at a location within the Territory mutually agreed by the Parties. Each Party will bear all the expenses of its representatives on the JDC. The JDC chairperson will issue an agenda reasonably in advance of each meeting for review and comment by the other Party’s JDC representatives. The other Party’s JDC representatives shall have five (5) days to review and comment on the agenda. The JDC chairperson shall incorporate all reasonable comments of the Party’s representatives to the JDC in the agenda, and that agenda (i.e., with the reasonable comments of the other Party’s JDC representatives) shall be the agenda for the relevant meeting of the JDC. The JDC chairperson will appoint one (1) member of the JDC from the other Party to keep accurate minutes of each meeting and that person will use all reasonable efforts to circulate draft minutes of each JDC meeting to all JDC representatives for comment and review within five (5) business days after the relevant meeting. The JDC representatives will have ten (10) business days from the date of circulation of such draft minutes to provide comments. The JDC representative preparing the minutes will incorporate timely received comments and, after receiving approval from the JDC chairperson, distribute finalized minutes to all JDC representatives within twenty (20) business days after the relevant meeting. A meeting of the JDC will be effective only if it has been duly called in writing upon at least twenty (20) business days prior notice, an agenda for the meeting is circulated at least ten (10) business days prior to the meeting, and at least the JDC chairperson (or his or her designee) and at least one representative from each Party are present or participating in such meeting. The JDC and each subcommittee will take action only by unanimous consent. If any subcommittee is unable to decide a matter unanimously after five (5) business days of due consideration, then such disagreement will be submitted to the JDC. Each of CCP and Fibrocell will have one (1) collective vote on the JDC regardless of how many representatives such Party has in attendance at such meeting, and any matter voted on will require the unanimous vote of both Parties. If a disagreement among members of the JDC remains unresolved for more than ten (10) days after the JDC first addresses such matter (or such longer period as the Parties may mutually agree upon), such disagreement will be resolved in accordance with Section 3.2(d). (d) Dispute Resolution. If the JDC is unable to resolve any dispute, controversy, or claim arising under this Agreement, including matters escalated to the JDC by 16 US-DOCS\106669270.9


 
any subcommittee, within ten (10) days after it first addresses such matter (or such longer period as the Parties may mutually agree upon), then the dispute will be referred to senior executive officers of each Party having authority to make decisions in such matters (“Executives”) of each Party, and, in the event the Executives of each Party are unable to resolve the dispute within ten (10) days after receiving notice of the dispute (or such longer period as the Parties may mutually agree upon), then the matter will be finally decided by CCP. For clarity, matters relating to a Party’s alleged breach of its obligations under this Agreement will not be finally decided by CCP but may be submitted for resolution by either Party, after the applicable discussion periods set forth above have expired, to a court of competent jurisdiction as set forth in Section 19.10. Notwithstanding the foregoing, neither the JDC nor CCP shall use its final decision making authority to (i) dissolve any subcommittee of the JDC once established except as set forth in Section 3.3, (ii) allocate to a Party any authority intended to be delegated to the JDC, (iii) resolve any dispute as to what level of efforts constitutes Commercially Reasonable Efforts, (iv) alter or amend the Development Budget in a manner that would increase the Development Costs above the Development Cost Cap or that would reduce the Initial Development Costs to an amount less than what is set forth in the initial Development Budget; (v) require any Party to take any action that would, or fail to take any action where the failure to take such action would, to the knowledge of CCP, (A) violate Applicable Laws or any agreement with any Third Party, or (B) infringe the intellectual property rights of any Third Party; (vi) frustrate the purpose of this Agreement or any provision hereof; or (vii) amend the Development Plan to include the Development of any indication or use for the Product other than the Initial Indication. The JDC will have no power to alter, amend, modify or waive compliance with this Agreement or Applicable Law, to interpret, alter, increase, expand, or waive a Party’s rights or obligations under this Agreement, including to expand Development of the Product under the Development Plan into any indication(s) other than the Initial Indication, or, subject to Section 9.2(a), to increase the scope of any Party’s responsibilities under this Agreement or cause any Party to spend amounts in furtherance of the Development Plan in excess of those amounts budgeted in the initial Development Plan. 3.3 Dissolution of the JDC. The JDC and any subcommittees will exist until such time as CCP decides to dissolve the JDC; provided, that the JDC and any subcommittee may not be dissolved until the Commercial Launch in the Territory, and provided further, that upon such dissolution, CCP will establish a replacement governance structure that is materially consistent with the governance structure provided under this Article 3 that will provide Fibrocell with substantially the same representation, consultation and other rights with respect to the matters that were otherwise subject to the monitoring and oversight of the JDC. Each subcommittee will exist until such time as the JDC decides to dissolve such subcommittee. In the event that any subcommittee is dissolved, the JDC will take on all of the responsibilities of such subcommittee. 4. DEVELOPMENT PROGRAM 4.1 Project. During the period of time in which the Product is being Developed, the Parties will cooperate with each other to provide reasonable support in the conduct of all activities that are reasonably necessary or useful for the Development of the Product in the Territory consistent with the Development Plan. Notwithstanding the foregoing, Fibrocell will, subject to the authority of the JDC, be solely responsible for the Development of 17 US-DOCS\106669270.9


 
the Product for the Initial Indication through Initial BLA Approval, and CCP will be solely responsible for Development of the Product for the Initial Indication thereafter. Each Party will be responsible for conducting the activities assigned to it in the Development Plan under the direction and supervision of the JDC, provided, that neither Party will be assigned obligations under the Development Plan without such Party’s prior written approval, which will not be unreasonably withheld, delayed or conditioned, it being understood that each Party has approved and consented to the Development Plan and Development Budget attached hereto as Exhibits 4.2(a)(i) and 4.2(a)(ii), and a Party will act reasonably when considering amendments to the initial Development Plan and Development Budget. Each Party will be responsible for selection and supervision of its personnel assigned to tasks related to Development activities. The JDC will be responsible for making, and have authority to make, all decisions, and undertake any actions necessary as a result of such decisions, regarding Development (including additional preclinical and clinical Development and testing) and preparing and filing BLAs and any other applications for Regulatory Approval, all in a manner consistent with this Agreement; provided that the JDC will not take any action for the purpose of delaying milestone payments to be made under Article 9. Subject to JDC oversight as set forth in Section 3.2, each Party will carry out its obligations under the development program in accordance with the Development Plan. 4.2 Development Plan and Development Budget. (a) The Development of the Product will be governed by a Development plan (“Development Plan”), and the costs and expenses relating to the Development of the Product will be governed by a Development budget (“Development Budget”), the initial agreed versions of which are attached as Exhibits 4.2(a)(i) and 4.2(a)(ii), respectively. Updates thereto made pursuant to Section 4.2(b) will be prepared by the JDC; provided, that either Party may propose updates to the Development Plan to be made by the JDC. Each Development Plan may include, as mutually agreed by the Parties: (1) a description of all Clinical Trials to be conducted by Fibrocell and, if applicable, CCP to support Regulatory Approval in the Territory, and related timelines; (2) other material activities necessary for Development of the Product in the Territory; (3) the proposed overall program of Development for the Product in the Territory, including all preclinical studies, toxicology, pharmacology studies, formulation, process development, clinical studies, and Regulatory Plans and other elements of obtaining Regulatory Approval in the Territory; (4) at an appropriate stage of Development, a publication strategy; (5) the roles and responsibilities of each Party and the JDC, and, if applicable, each subcommittee of the JDC; and (6) plans related to clinical Manufacturing of the Product and to Manufacturing scale-up to enable commercial scale manufacturing prior to Commercial Launch. The Development Plan and the Development Budget will be updated at least once per calendar year in accordance with Section 4.2(b) and will cover the following three (3) calendar year period. (b) The JDC will, on an annual basis, prepare and approve updates to the Development Plan and Development Budget by September 30 of each calendar year for the following three (3) calendar year period, which updates shall be subject to the unanimous consent of the JDC through Initial BLA Approval. From time to time in between such annual updates, the JDC may amend the Development Budget or Development Plan, consistent with the principles set forth in Section 4.1. 18 US-DOCS\106669270.9


 
(c) The costs of the Development activities set out in each Development Plan as set forth in the applicable approved Development Budget will be allocated between the Parties as set out in Article 9, provided that CCP will be solely responsible for the first twenty million Dollars ($20,000,000) of such costs. The Parties agree that the total amount of the Fibrocell costs set forth in the initial Development Budget attached hereto as Exhibit 4.2(a)(ii) will be reimbursed to Fibrocell in accordance with Section 9.2 to the extent that Fibrocell actually incurs such costs. 4.3 Technical Cooperation. Upon request, each Party will provide reasonable assistance and technical expertise as necessary to transfer appropriate technology to the other Party to support Development of the Product under this Agreement; provided, such assistance and technical expertise by a Party shall not exceed forty (40) hours per month. Such assistance may include the grant of appropriate rights of access and reference to regulatory filings to enable the Parties to assume responsibility for Development of the Product, and participation in meetings with regulatory agencies with respect to the Product. 4.4 Compliance with Applicable Laws. Each Party, in performing its activities under this Agreement, will comply with all Applicable Laws, including where applicable, then-current GCP, GLP, GMP, and applicable Health Care Laws. 4.5 Subcontracting Permitted. (a) CCP acknowledges and agrees that portions of the work to be performed by Fibrocell under this Agreement may be performed on behalf of Fibrocell by Third Parties, provided that (i) Fibrocell will first have obtained written confidentiality agreements with any such subcontractors and written assignments of, or equivalent rights under, all Patent rights, know-how and other intellectual property rights that such subcontractors may develop by reason of work performed under this Agreement, (ii) any such subcontractors must be approved by CCP in advance in writing (such approval not to be unreasonably withheld, conditioned or delayed), provided that the subcontractors identified on Exhibit 4.5(a) will be deemed pre- approved, and (iii) Fibrocell will be and remain responsible to CCP for the performance of its subcontractors. Without limiting the generality of the foregoing, Fibrocell will include in its agreements entered into after the Effective Date with each of its subcontractors under this Section 4.5(a), (A) a right for CCP to receive, directly or through Fibrocell, any confidential information of such subcontractor disclosed under or related to such subcontract (including any information obtained in connection with any audit of such subcontractor) that is reasonably necessary for CCP to perform its obligations or exercise its rights under this Agreement, and (B) a right to audit the performance of such subcontractor under such subcontract, including through audit of any applicable books, records, data or other Information of such subcontractor, consistent with industry practice. (b) Fibrocell acknowledges and agrees that portions of the work to be performed by CCP under this Agreement may be performed on behalf of CCP by Third Parties, provided that (i) CCP will first have obtained written confidentiality agreements with any such subcontractors and written assignments of, or equivalent rights under, all Patent rights, know- how and other intellectual property rights that such subcontractors may develop by reason of work performed under this Agreement, and (ii) CCP will be and remain responsible to Fibrocell 19 US-DOCS\106669270.9


 
for the performance of its subcontractors. Without limiting the generality of the foregoing, CCP will include in its agreement with each of its subcontractors under this Section 4.5(b), (A) a right for Fibrocell to receive, directly or through CCP, any confidential information of such subcontractor disclosed under or related to such subcontract (including any information obtained in connection with any audit of such subcontractor) that is reasonably necessary for Fibrocell to perform its obligations hereunder, and (B) a right to audit the performance of such subcontractor under such subcontract, including through audit of any applicable books, records, data or other Information of such subcontractor, consistent with industry practice. 5. REGULATORY MATTERS 5.1 Pharmacovigilance Agreement. The Parties will, within sixty (60) days after written request by the JDC, convene a meeting to negotiate in good faith the terms and conditions of a pharmacovigilance agreement (“Pharmacovigilance Agreement”), which will establish all material economic, regulatory, business and technical terms under which the Parties will, consistent with Section 5.3, collect, monitor, research, assess and evaluate information from healthcare providers and patients on the adverse effects, if any, of the Product for their respective territories, with a view to identifying new information about hazards associated with the Product and preventing harm to patients. Within ninety (90) days after the commencement of those negotiations, the Parties will work in good faith to execute a mutually satisfactory Pharmacovigilance Agreement. 5.2 Preparation of Regulatory Filings. (a) The Parties will develop and agree to a detailed regulatory plan for the Product in or for the Territory (the “Regulatory Plan”), which Regulatory Plan, once mutually agreed by the Parties, will be deemed to form part of the Development Plan. Unless otherwise provided in the Development Plan, each Party, unless otherwise provided for in this Agreement, will be responsible for preparing, filing, and maintaining, and will own, the regulatory filings relating to the Product as set forth in Section 5.2(b). (b) Until the date of Initial BLA Approval, Fibrocell or its designee will be responsible for all interactions with Regulatory Authorities and will submit regulatory filings to the respective Regulatory Authority with regard to the Product for the purpose of filing, obtaining and maintaining Regulatory Approval thereof, and to prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals covering the Product in the Territory. CCP or its designee will be responsible for such interactions and filings thereafter. Fibrocell will provide CCP with a copy of all regulatory filings, correspondence with and minutes of meetings with Regulatory Authorities, documents included in such regulatory dossiers and Regulatory Approvals. At all times during the term of this Agreement, (i) Fibrocell will keep CCP informed of all regulatory filings for the Product and will provide CCP a meaningful opportunity to review and comment on those filings prior to submission thereof, and Fibrocell will in good faith consider incorporating such comments into, any such regulatory filings in the Territory; and (ii) CCP will have the opportunity, unless such Regulatory Authorities object, to participate in all meetings with Regulatory Authorities relating to the Product. 20 US-DOCS\106669270.9


 
5.3 Notice of Communication with Regulatory Authorities. (a) Until the date of Initial BLA Approval, Fibrocell will be responsible for reporting all adverse events and handling all complaints and communications (including with Regulatory Authorities) relating to the Product in the Territory. CCP or its designee will be responsible for such interactions and filings thereafter, except to the extent set forth in the Supply Agreement or the Quality Agreement. (b) Except as otherwise provided for in this Section 5.3, each Party will provide monthly summaries to the other Party of any material oral or written communications to or from Regulatory Authorities on matters related to the Product or which would reasonably be expected to impact Product Development, Manufacture, Commercialization or Regulatory Approval. Notwithstanding the foregoing, each Party will notify the other Party of any oral communications, and provide such other Party with copies of any written communications, or internal written memoranda, notes or summaries of oral communications, to or from Regulatory Authorities on matters related to Products, or which may reasonably be deemed to impact Products, within three (3) business days of receipt of such communication (or for informal communications, as soon as reasonably practicable, if longer), or such earlier date as required by Applicable Law or Regulatory Authority. Moreover, in each such case, each Party will give the other Party reasonable opportunity to review and comment on any proposed response to any such oral or written communications to or from Regulatory Authorities prior to submitting any response thereto, and provide such other Party with a copy of the final response as specified herein. Each Party shall reasonably cooperate with and assist the other Party in complying with regulatory obligations and communications, including by providing to such other Party, in a timely manner after a request, Information and documentation in such Party’s possession as may be necessary or helpful for such other Party to prepare a response to an inquiry from a Regulatory Authority, and by participating in any meeting with a Regulatory Authority at such other Party’s reasonable request and expense. Each Party shall provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above. (c) If a Regulatory Authority desires to conduct an inspection or audit of any facility of Fibrocell or any of its Affiliates or any Third Party facility under contract with Fibrocell, in each case with regard to the Product, then Fibrocell shall notify CCP as soon as practicably possible after receipt of such notification of such audit or inspection and provide copies of any materials provided to it by the applicable Regulatory Authority. In addition, if a Regulatory Authority conducts an unannounced inspection or audit of any facility of Fibrocell or any of its Affiliate or any Third Party facility under contract with Fibrocell, in each case with regard to the Product, then Fibrocell shall notify CCP within twenty-four (24) hours of (i) with respect to Fibrocell’s facilities, commencement of such audit or inspection or (ii) with respect to Third Party facilities, Fibrocell’s receipt of notification of such audit or inspection. Each Party shall cooperate, and shall use reasonable efforts to cause the contract facility to cooperate, with any Regulatory Authority and the other Party during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority, Fibrocell shall promptly provide CCP with a copy of the inspection or audit report and also provide CCP with copies of any written communications received from Regulatory Authorities with respect to such facilities in a timely manner after receipt, to the extent such written communications relate to the Product 21 US-DOCS\106669270.9


 
or the Manufacture thereof, and shall prepare the response to any such observations. Fibrocell shall provide CCP with a copy of any proposed response to such communications and shall implement CCP’s reasonable comments with respect to such proposed response to the extent such comments are provided with sufficient time to respond to such Regulatory Authorities. Fibrocell agrees to use reasonable efforts to conform its activities under this Agreement to any commitments made in such a response. 5.4 Regulatory Compliance. Each of Fibrocell and CCP will reasonably cooperate with the other Party in that Party’s efforts toward ensuring that all government price and gift reporting, fraud and abuse, sales, marketing and promotional practices with respect to the Product meet the standards required by Applicable Laws, including state and federal laws and regulations and including the Physician Payments Sunshine Act and similar state laws, as well as applicable guidelines concerning the advertising of prescription drug products. 5.5 Regulatory Documentation. Fibrocell will own and retain all right, title and interest in and to all Regulatory Approvals and all regulatory documentation with respect to the Product until one (1) business day following the date of Initial BLA Approval of the Product. 5.6 BLA Transfer. Effective as of one (1) business day following the date of Initial BLA Approval of the Product, Fibrocell hereby assigns to CCP the BLA and all directly related regulatory documentation for the Product, and CCP will own all right, title and interest in to such BLA and documentation for the Product thereafter; provided, that, except as expressly provided in this Agreement, including Section 5.10, CCP shall not be assigned and shall not obtain any right, title or interest in any regulatory documentation (which, for clarity, shall not include the BLA) that is necessary for any product other than the Product and for the Product outside of the Territory. Within ninety (90) days of Initial BLA Approval of the Product, Fibrocell will transfer such BLA and all related regulatory documentation for the Product to CCP, subject to the preceding sentence. CCP will provide copies of such documentation to Fibrocell at Fibrocell’s request to the extent required to fulfill Fibrocell’s obligations under the Intrexon Agreement with respect to such Product. 5.7 Product Recall. The Manufacturing and Supply Agreement and/or related Quality Agreement will contain standard provisions acceptable to both Parties regarding (a) a Regulatory Authority’s issuance or request of a recall or similar action in connection with the Product in the Territory and (b) either Party’s determination that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal in the Territory. 5.8 Cooperation. Fibrocell will cooperate with CCP in providing data and other information generated in connection with Clinical Trials or other Development or Manufacture of Products conducted by or on behalf of Fibrocell prior to or after the Effective Date and under Fibrocell’s reasonable control for use in connection with Pre-Launch Activities, medical policy development for distribution to medical directors, pharmacy directors and other key formulary committee members for education and development of RDEB medical policy serving both the medical and payer communities, patient access and advocacy, managed markets and medical affairs activities, and commercial and government payer education. 22 US-DOCS\106669270.9


 
5.9 Priority Review Voucher. Fibrocell will retain sole ownership and control of the Rare Pediatric Disease Priority Review Voucher issued in connection with the Initial BLA Approval of the Product. 5.10 Rights of Reference to Regulatory Materials. Fibrocell hereby grants to CCP a right of reference to all regulatory materials filed with FDA by Fibrocell for the Product solely to the extent required or useful for the purposes of the Development, including seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Product in the Territory in the Initial Indication. 6. COMMERCIALIZATION 6.1 Responsibility for Commercialization. As between the Parties, CCP will be solely responsible for the Commercialization of the Product in the Territory, including planning and implementation, detailing, booking of sales, pricing and reimbursement. 6.2 Packaging; CCP Trademarks. Fibrocell will be responsible for all packaging (non-commercial and commercial) and labeling of the Product. To the extent consistent with Applicable Laws, all Product labeling and packaging, including Product packaging and package inserts and any promotional materials associated with the Product in the Territory will carry, in a conspicuous location, and at CCP’s instruction, the Trademark of CCP. CCP authorizes the use of its Trademarks pursuant to this Section 6.2. 7. MANUFACTURE AND SUPPLY OF PRODUCT 7.1 Commercial Manufacturing. The Parties will use good faith efforts to enter, within three (3) months after the Effective Date, into a commercial manufacturing agreement (“Manufacturing and Supply Agreement”) and related quality agreement (the “Quality Agreement”), which sets forth the material economic, quality, safety, business and technical terms under which Fibrocell will supply to CCP commercial supplies of Product for the Territory. 8. DILIGENCE 8.1 By Fibrocell. Fibrocell will use Commercially Reasonable Efforts to Develop the Product in the Territory in accordance with the terms of this Agreement and to conduct the activities assigned to it under the Development Plan. 8.2 By CCP. (a) CCP will use Commercially Reasonable Efforts to Commercialize the Product in the Territory following receipt of Initial BLA Approval of the Product, including in accordance with the Product Launch Plan for the period such plan is in effect and to the extent applicable. Without limiting the foregoing, CCP will use Commercially Reasonable Efforts to ensure that the date of the Commercial Launch of the Product in the Territory occurs within twelve (12) months following Initial BLA Approval of the Product. CCP shall conduct all Commercialization activities with respect to the Product hereunder in compliance with Applicable Laws. 23 US-DOCS\106669270.9


 
(b) No later than nine (9) months prior to the anticipated date of Commercial Launch of the Product in the Territory, CCP shall prepare and provide to Fibrocell a preliminary Product launch plan summarizing CCP’s plans for Pre-Launch Activities and Commercialization of the Product in the Territory for the first eighteen (18) months following the date of the Commercial Launch in the Territory (the “Product Launch Plan”). No fewer than ninety (90) days prior to the end of each calendar year beginning with the first calendar year after Commercial Launch of the Product in the Territory, CCP shall provide an annual summary of marketing efforts in the Territory and, to the extent necessary, updates to the Product Launch Plan. 9. PAYMENT OBLIGATIONS 9.1 Upfront Payment. Within five (5) Business Days after the Effective Date, CCP will make a non-refundable, non-creditable, one-time payment to Fibrocell in the amount of seven million, five hundred thousand Dollars ($7,500,000). 9.2 Development Cost Sharing. Subject to the oversight of the JDC and compliance with the Development Plan and Development Budget, CCP will be solely responsible for, at its sole expense, all Development Costs incurred in accordance with the Development Plan and Development Budget in connection with the Development of the Product in the Territory until the date of the initial BLA Regulatory Approval of the Product in the Territory (such costs, “Initial Development Costs”; such approval of the Product, “Initial BLA Approval”), up to twenty million Dollars ($20,000,000) (the “Initial Cost Cap”). If Initial Development Costs, including as set forth in an applicable approved Development Budget and any variances to the Development Budget approved in accordance with Section 3.2(b), exceed the Initial Cost Cap the Parties will each be responsible for such excess Initial Development Costs (the “Excess Initial Development Costs”) as follows: (i) CCP will be responsible for seventy percent (70%) of such Excess Initial Development Costs, and (ii) Fibrocell will be responsible for thirty percent (30%) of such Excess Initial Development Costs. Each Party will promptly notify the other Party upon becoming aware that the actual or anticipated Development Costs to be incurred by such Party for a given calendar year will be in excess of the applicable Development Budget (“Cost Overruns”). The JDC shall promptly review any projected Cost Overrun that is reported to it and thereafter may, at its discretion, approve (a) an appropriate variance to the applicable Development Budget, which variance shall be considered part of the approved Development Budget, provided that any such variance or variances will be deemed approved to the extent all such variances, in aggregate, do not cause then current Development Budget to be increased by more than five percent (5%) or (b) such other amendments to the approved Development Plan as may be necessary or appropriate to bring the Development Costs within the budgetary guidelines set forth in the applicable Development Budget (provided that such amendments do not exceed the Development Cost Cap (as defined below)). Neither Party shall exceed the applicable amounts set forth in the Development Budget to be incurred by such Party without the prior approval of the JDC. Notwithstanding the foregoing, the JDC shall not approve any changes to the Development Budget that would result in Development Costs that exceed thirty million Dollars ($30,000,000) (the “Development Cost Cap”) without the mutual agreement of both Parties, and, if the Parties are unable to agree to such amendment to the Development Budget, the last approved Development Budget shall remain in place. 24 US-DOCS\106669270.9


 
9.3 Profit Sharing. Commencing upon Initial BLA Approval in the Territory through the term of this Agreement, the Parties will share all Product Gross Profit on sales of the Product in the Territory: (i) CCP will receive seventy percent (70%) of Product Gross Profit; and (ii) Fibrocell will receive thirty percent (30%) of Product Gross Profit. 9.4 Method and Timing of Payments. Within thirty (30) days after the end of each calendar quarter during the term of this Agreement (including partial calendar quarters), each Party will provide a report to the JDC and the other Party as follows: (a) prior to Commercial Launch in the Territory, Fibrocell will report the Development Costs eligible for cost sharing hereunder incurred by Fibrocell in such calendar quarter (with appropriate supporting information); (b) following Commercial Launch in the Territory, CCP will report CCP’s Net Sales and Fully Burdened Manufacturing Costs necessary for the computation of Product Gross Profit for such calendar quarter, and any Development Costs of CCP, if applicable. The reports and payments due pursuant to this Section 9.4 for each calendar quarter will include any reconciliations and adjustments with respect to previous quarters necessary to effect the sharing of Product Gross Profit set forth in Section 9.3. CCP will be responsible for the preparation of consolidated reporting, calculation of Product Gross Profit and each Party’s share of Development Costs and Product Gross Profit, and determination of the cash settlement. CCP will provide to Fibrocell within thirty (30) days after its receipt of Fibrocell’s quarterly report of Development Costs, a statement showing the calculations of Development Costs, including Excess Initial Development Costs, and Product Gross Profit for such calendar quarter (each, a “Balancing Statement”), in each case to the extent eligible for sharing under this Agreement, and any cash settlement required. Payments (including any reconciling payments for previous quarters) will be made for each calendar quarter during the term of this Agreement (including partial calendar quarters) within thirty (30) days after Fibrocell’s receipt of the Balancing Statement to effect the Parties’ sharing of Excess Initial Development Costs or Product Gross Profit, as applicable, as set forth in this Agreement. For clarity, the Parties will conduct a final accounting in accordance with this Section 9.4 promptly upon expiration or termination of this Agreement, and any final balancing payment will be paid within thirty (30) days of receipt of the final Balancing Statement. 9.5 Milestone Payments. (a) Subject to Section 9.5(b), CCP will make the following non- refundable, non-creditable Milestone Payments (the “Milestone Payments”) to Fibrocell, with respect to the Product, within sixty (60) days after achievement of the relevant milestone for the Product. The milestones in this Section 9.5 are cumulative, such that under no circumstances is any single Milestone Payment to be deemed in lieu of, or to be substituted for, another Milestone Payment. For clarity, each milestone in this Section 9.5 is payable by CCP to Fibrocell only once with respect to the achievement of any milestone under this Agreement. Milestone Event Payment Commencement of the first Phase III Clinical Trial designed $2,500,000 consistent with end-of-Phase II Clinical Trial FDA feedback Upon the later of (i) Initial BLA Approval with an approved label $30,000,000 25 US-DOCS\106669270.9


 
Milestone Event Payment indication of RDEB and (ii) Fibrocell proving and demonstrating in CCP’s reasonable determination that it has sufficiently scaled Product Manufacturing in accordance with the Process Validation Protocol, with capacity of at least two hundred fifty (250) incoming biopsies per calendar year Upon the first achievement of $250,000,000 in cumulative Net Sales $25,000,000 of the Product in the Territory by CCP or its Affiliates or Sublicensees after BLA Regulatory Approval by FDA Upon the first achievement of $750,000,000 in cumulative Net Sales $50,000,000 of the Product in the Territory by CCP or its Affiliates or Sublicensees after BLA Regulatory Approval by FDA Total $107,500,000 (b) In the event any failure by Fibrocell to comply with GMP, GLP or GCP or other requirements under this Agreement in connection with the Development or Manufacture of the Product that results in the delay of Initial BLA Approval of the Product, or any disruption in commercial supply of the Product after Initial BLA Approval, then in addition to any other remedies available to CCP under this Agreement or the Manufacturing and Supply Agreement, CCP shall have the right to offset against any future, unpaid milestone payments due to Fibrocell under Section 9.5(a) an amount equal to CCP’s actual costs incurred in connection with remediating or mitigating any such delay or disruption, but not other losses or damages of CCP, including those associated with lost profits or lost sales. 9.6 Disputed Payments. The Parties will confer in good faith to resolve any payment dispute, and if such dispute is not resolved to the satisfaction of both Parties within the sixty (60)-day period specified above, such disputed amounts as set forth in the Balancing Statement will nonetheless be immediately due and payable by the applicable paying Party within thirty (30) days thereafter, it being understood that such paying Party may also exercise its audit rights under Article 10 and/or dispute resolution rights under Section 19.10 to receive a credit or refund of such payment upon final resolution of the dispute. 9.7 Currency of Payment. All payments to be made under this Agreement will be made in Dollars. 9.8 Accounting. (a) The fiscal year with respect to this Agreement will be a calendar year. CCP will determine Net Sales and Fully Burdened Manufacturing Costs with respect to the Product using its standard accounting procedures, consistent with GAAP and all other products owned or controlled by CCP, to the extent practical as if the Product was a solely owned product of CCP, except as specifically provided in this Agreement. In the case of amounts to be determined by Third Parties (for example, Net Sales by Sublicensees), such amounts will be 26 US-DOCS\106669270.9


 
determined in accordance with GAAP. The Parties also recognize that such procedures may change from time to time and that any such changes may affect the definition of Net Sales or Fully Burdened Manufacturing Costs. The Parties agree that, where such changes are economically material to either Party, adjustments will be made to compensate the affected Party in order to preserve the same economics as are reflected under this Agreement under such Party’s accounting procedures in effect prior to such change (for example, Development or Commercialization). Where the change is or would be material to one Party, the other Party will provide an explanation of the proposed change and an accounting of the effect of the change on the relevant revenue, cost, or expense category. (b) In the event of the payment or receipt of non-cash consideration in connection with the performance of activities under this Agreement, the Party engaging in such non-cash transaction will advise the other Party of such transaction, including such Party’s assessment of the fair market value of such non-cash consideration and the basis therefor. Such transaction will be accounted for on a cash equivalent basis, as mutually agreed by the Parties in good faith. 9.9 Withholding Tax. Any Party required to make a payment to any Party under this Agreement will be entitled to deduct and withhold from the amount otherwise payable such amounts to the extent it is required to deduct and withhold with respect to such payment under any provision of federal, state, local or foreign tax law. Such withheld amounts will be treated for all purposes of this Agreement as having been paid to the Party on whose behalf it was withheld. No deduction will be made to the extent the paying Party is timely furnished with necessary documents certifying that the payment is exempt from tax or subject to a reduced tax rate. 10. RECORD KEEPING, RECORD RETENTION AND AUDITS 10.1 Record Keeping. Each Party will record, and will require its Affiliates, Sublicensees, and subcontractors to record, to the extent reasonably practical, all Information relating to this Agreement and all research and Development activities contemplated by this Agreement in accordance with its internal practices and industry standards. Such records will be complete and accurate in all material respects and will fully and properly reflect all such work done and results achieved in sufficient detail and in good scientific manner appropriate for regulatory purposes. Each Party will have the right to receive and retain a copy of all such records at reasonable times, upon reasonable prior written notice to the other Party. CCP will also have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Fibrocell, its Affiliates or its subcontractors and sublicensees, where Development or Manufacturing activities are conducted, as is reasonably necessary solely for the purpose of verifying Fibrocell’s compliance with this Agreement and applicable GLP, GCP, GMP and other regulatory requirements in or for the Territory. All audits initiated by CCP will be conducted at CCP’s sole expense, upon reasonable prior notice to Fibrocell, and during regular business hours. To the extent practical, the notebooks of each Party for this Agreement will be separate from notebooks documenting other research and development of such Party. 27 US-DOCS\106669270.9


 
10.2 Record Retention. Fibrocell will keep complete and accurate records pertaining to the research, Development and Manufacture of the Product in sufficient detail to permit CCP to verify the costs related to the foregoing for which CCP is responsible for paying, reimbursing or sharing. CCP will keep complete and accurate records pertaining to the Net Sales of the Product and Fully Burdened Manufacturing Costs, which documents would enable Fibrocell to confirm the accuracy of calculations of all payments made by CCP under this Agreement The records to be maintained by each Party under this Section 10.2 will be maintained for a minimum of five (5) years following the year in which the corresponding efforts or payments, as the case may be, were made under this Agreement or longer if required by Applicable Law. 10.3 Audit Request. Each Party will, at its expense (except as provided below), have the right to audit, not more than once during each calendar year and during regular business hours, the records maintained by the other Party under Section 10.2, to determine with respect to any calendar year, the accuracy of any report or payment made under this Agreement in the five (5) preceding years. If a Party desires to audit such records, it will engage an independent, certified public accountant reasonably acceptable to the other Party, to examine such records under conditions of confidentiality. Such accountant will be instructed to provide to the auditing Party a report verifying any report made or payment submitted by the audited Party during such period, but will not disclose to the auditing Party any confidential Information of the audited Party not necessary therefor. The expense of such audit will be borne by the auditing Party; provided, however, that, if an error of more than ten percent (10%) is discovered, then such expenses will be paid by the audited Party. If such accountant concludes that additional payment amounts were owed to a Party during any period, the debtor Party will pay such payment amount (including interest thereon from the date such amounts were payable) within thirty (30) days after the date the creditor Party delivers to the debtor Party such accountant’s written report so concluding, unless the debtor Party notifies the creditor Party of any dispute regarding the audit and commences proceedings under Section 19.10 within thirty (30) days after delivery of the accountant’s report (in which case the payment will be delayed until conclusion of the proceeding). Such auditors will not be paid on a contingency basis. Any Information received by an auditing Party pursuant to this Section 10.3 will be deemed to be Confidential Information of the audited Party. 10.4 Survival. This Article 10 will survive any termination or expiration of this Agreement for a period of five (5) years following the final payment made by CCP or Fibrocell hereunder, or longer if required by Applicable Law. 11. INVENTIONS, KNOW-HOW AND PATENTS 11.1 Existing Intellectual Property. Other than as expressly provided in this Agreement, neither Party grants to the other Party any right, title, or interest in any Patent rights, Information, or other intellectual property right Controlled by such Party. 11.2 Ownership of Inventions. (a) Ownership of inventions arising during and in the course of the Parties’ performance under this Agreement, and related intellectual property rights 28 US-DOCS\106669270.9


 
(“Inventions”) will be determined in accordance with U.S. rules of inventorship, except as otherwise set forth in this Section 11.2(a). Each Party will promptly disclose, and will cause its Sublicensees and Affiliates to disclose, to the other Party any Inventions that it or its Affiliates or Sublicensees or their respective employees, independent contractors or agents solely or jointly make, conceive, reduce to practice, author, or otherwise discover. Each Party will require its employees, consultants and contractors to disclose any Inventions relating to this Agreement in writing promptly after conception. (b) Assignment and Perfection of Interests. Each Party will, and will cause its Affiliates and Sublicensees and their respective employees, independent contractors and agents to, cooperate with the other Party and take all reasonable additional actions and execute such agreements, instruments and documents as may be reasonably required to perfect the other Party’s right, title and interest in and to Inventions, Patent rights and other intellectual property rights as such other Party has pursuant to Section 11.2(a). Each Party will also include provisions in its relevant agreements with Affiliates and Third Parties that effect the intent of this Section 11.2(b). 11.3 Patent Prosecution and Maintenance. (a) Fibrocell will file and prosecute Patent Applications and maintain Patents in a manner consistent with optimizing Patent protection on Inventions and other inventions Controlled by Fibrocell that are disclosed and/or claimed in the Fibrocell Patent Rights. Each Party will cause its patent counsel to confer no less frequently than once each calendar month regarding the status of all such Patent Applications and Patents for which it is responsible under this Section 11.3, and whether and in which countries foreign counterparts of such Patent Applications and Patents will be filed. The Parties will set the location, date, time and type of meeting (either in person, by teleconference, or by videoconference) so as to be mutually agreeable to the patent counsel of each Party. Each Party will consider the other Party’s comments in good faith and will include any reasonable input from the other Party in any Patent filings or communications with applicable Patent offices. (i) Fibrocell will bear the full costs and expense of and be responsible for filing, prosecuting and maintaining (1) Patents and Patent Applications claiming inventions it Controls as of the Effective Date and during the term of this Agreement and those it Controls that arise outside the Parties’ performance pursuant to this Agreement, and (2) Patents and Patent Applications on Inventions it solely owns under this Agreement; provided, that Fibrocell shall not be responsible for costs incurred by CCP with respect to those Patents and Patent Applications. If Fibrocell does not wish to file, prosecute or maintain any such Patent Applications or Patents that relate to the Product, a component of the Product, or a method of using or manufacturing the Product or any component thereof in or for the Territory (“Product Patents”), Fibrocell will give CCP reasonable written notice to such effect and, subject to any rights of Intrexon with respect to the prosecution of such Product Patents under Section 6.2(a) of the Intrexon Agreement, will grant CCP any necessary authority to file, prosecute and maintain such Product Patents in CCP’s own name and at CCP’s sole expense. In such event, and subject to any rights of Intrexon with respect to the ownership of such Product Patents under Section 6.1 of the Intrexon Agreement, Fibrocell will assign to CCP its entire right, title and interest in and to such Product Patents. Notwithstanding the foregoing, after the Effective Date, Fibrocell will 29 US-DOCS\106669270.9


 
file Patent Applications included within the Fibrocell Patent Rights in the Territory and any country in which Manufacturing activities may be performed and Fibrocell will give CCP reasonable written notice of the countries and regions in which it will file such Patent Applications in order to permit CCP reasonable time to file such Patent Applications in any country in which Fibrocell will not be filing. If CCP wishes to file such Patent Applications in any additional countries, Fibrocell will provide CCP with copies of any documents necessary to conduct such filings and, subject to any rights of Intrexon with respect to the prosecution of such Product Patents under Section 6.2(a) of the Intrexon Agreement, will grant CCP any necessary authority to file, prosecute and maintain such Patent Applications in CCP’s own name and at CCP’s sole expense. In such event, Fibrocell will, subject to any rights of Intrexon with respect to the ownership of such Product Patents under Section 6.1 of the Intrexon Agreement, assign its entire right, title and interest in and to such Patent Applications in that country to CCP. CCP will bear the full costs and expense of and be solely responsible for prosecuting, maintaining, enforcing and defending any Patent or Patent Application assigned to CCP under this Section 11.3(a)(i). In the event that CCP chooses not to prosecute, maintain, enforce or defend any such Patents or Patent Applications, Fibrocell will have the option to do so at its sole cost and expense. (ii) CCP will bear the full costs and expense of and be responsible for filing, prosecuting and maintaining Patents and Patent Applications on Inventions it solely owns under this Agreement, at its sole discretion. (iii) For jointly owned Inventions, the Parties will select a mutually acceptable Third Party patent counsel to file, prosecute and maintain Patents and Patent Applications thereon on behalf of both Parties (“Joint Patent Rights”). All costs and expenses for Joint Patent Rights will be shared by the Parties equally. If either Party does not wish to file, prosecute or maintain any Joint Patent Rights in any country or pay its portion of any shared costs for Joint Patent Rights in any country, that Party will give the other Party reasonable written notice to such effect and will grant the other Party any necessary authority to file, prosecute, maintain or defend such Joint Patent Rights in the other Party’s own name and at the other Party’s sole expense. In such event, the Party will assign its entire right, title and interest in and to such Joint Patent Rights in that country to the other Party. Subject to the foregoing, each Party will be free to exploit such Joint Patent Rights, either itself or through the grant of licenses to Affiliates or Third Parties throughout the world, without restriction, without the need to obtain further consent from or provide notice to the other Party, and without any duty to account or otherwise make any payment of any compensation to the other Party. (b) Each Party will promptly disclose, and will cause its Sublicensees and Affiliates to disclose, to the other in writing all Inventions. Each Party will ensure that, to the extent permitted by Applicable Law, its Sublicensees and Affiliates and their respective employees, independent contractors, contractors and agents performing work pursuant to this Agreement are, and will cause its Affiliates performing work pursuant to this Agreement to be, under an obligation to assign to it all Inventions therein and intellectual property rights made or arising during and in the course of and as a result of the performance of such work or, where such obligation is not permitted in a particular country, to exclusively license to it all such Inventions and intellectual property rights, with the right to authorize or grant sublicenses in such country, or where neither of the foregoing obligations is permitted in a particular country then, to 30 US-DOCS\106669270.9


 
non-exclusively license to it all such Inventions and intellectual property rights, with the right to authorize or grant sublicenses in such country. 11.4 Third Party Licenses. If the Parties mutually and reasonably determine that certain Third Party intellectual property rights are necessary for the Exploitation of the Product, Fibrocell or CCP will at its expense obtain a license to such Third Party intellectual property, with the right to sublicense, in order to permit both Parties to conduct their obligations under this Agreement, and the expenses associated with such license, unless otherwise expressly provided in this Agreement, will be deducted from Net Sales for purposes of determining Product Gross Profits. If the Parties disagree on whether rights in Third Party intellectual property are reasonably necessary for the Exploitation of the Product, the JDC will be responsible for determining whether rights in such Third Party Patents and Patent Applications should be obtained and any dispute as to whether other Third Party intellectual property rights should be obtained shall be resolved through dispute resolution pursuant to Section 3.2(d); provided that if CCP uses its final decision making authority to determine a dispute under this Section 11.4, Fibrocell shall retain the right to dispute such decision pursuant to Section 19.10. 11.5 Infringement by Third Parties. (a) Enforcement. CCP will bear the full costs and expenses of enforcing, and will have the first right to enforce, Joint Patent Rights and, subject to Section 3.3 of the Intrexon Agreement and any enforcement rights of Intrexon under Section 6.3 of the Intrexon Agreement, Product Patents throughout the Territory, which right includes the right to control and settle the litigation (subject to the last sentence of this Section 11.5). If CCP does not initiate an enforcement action within ninety (90) days after the Parties first learn of such infringement, Fibrocell will have the right to enforce such Patents. All of the costs and expenses of both Parties incurred in connection with such proceedings will be borne by the Party bringing such action, and any recoveries will be awarded to the enforcing Party; provided, however, that any amounts recovered that are attributable to lost sales or lost profits shall be treated as Net Sales and will be taken into account in the calculation of Product Gross Profit. If, in any enforcement action taken pursuant to this Section 11.5, the enforcing Party determines that the other Party is an indispensable party to such action, the other Party hereby consents to be joined in such action and, in such event, the other Party will have the right to be represented in such action using counsel of its own choice at the enforcing Party’s expense. Notwithstanding the foregoing, each Party’s enforcement rights under this Section 11.5 will be subject to limitations imposed in any license agreement with a Third Party existing as of the Effective Date relating to the Patent to be enforced. The joint consent of CCP and Fibrocell (which consent will not be unreasonably withheld or delayed) will be required of any settlement, consent judgment or other voluntary final disposition of a suit under this Section 11.5 that could adversely affect the other Party’s interest. (b) Biosimilar Applications. Notwithstanding the provisions of Section 11.5(a), if either Party receives a copy of a Biosimilar Application referencing the Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 31 US-DOCS\106669270.9


 
U.S.C. §262(l)(2)), the remainder of this Section 11.5(b) will apply, then such Party will promptly, but in any event within ten (10) business days, notify the other Party. The owner of the relevant Patents will then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice will within five (5) business days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application: (i) CCP will designate, to the extent permitted by Applicable Law, or otherwise Fibrocell will designate in accordance with CCP’s instructions, the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii). (ii) In each case, after consulting with Fibrocell and considering Fibrocell’s comments in good faith, CCP will have the right to (a) list any patents, including those Patents within the Fibrocell Patent Rights, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents will be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). If Fibrocell is required pursuant to Applicable Law to execute any of these tasks it will do so in accordance with CCP’s reasonable instructions. (iii) Fibrocell will cooperate with CCP’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. CCP will consult with Fibrocell prior to identifying any Patents within the Fibrocell Patent Rights to a Third Party as contemplated by this Section 11.5(b). CCP will consider in good faith advice and suggestions with respect thereto received from Fibrocell, and notify Fibrocell of any such lists or communications promptly after they are made. (iv) Each Party will within five (5) business days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, CCP will have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. If required pursuant to Applicable Law, upon CCP’s request, Fibrocell will assist in seeking such injunction or filing such infringement action after consulting with CCP. Except as otherwise provided in this Section 11.5(b), any such action will be subject to the other terms and conditions of Section 11.5(a). 32 US-DOCS\106669270.9


 
11.6 Infringement Outside the Field. As between the Parties, Fibrocell will retain any and all rights to pursue an action against, and control all proceedings relating to, an infringement by a Third Party of the Fibrocell Patent Rights, except for Product Patents as otherwise provided in this Article 11, or Fibrocell Know-How that is not related to the Product, a component of the Product, or a method of using or manufacturing the Product or any component thereof or is exclusively outside the Field or the Territory. 11.7 Further Actions. Each Party will cooperate with the other Party to execute all documents and take all reasonable actions to effect the intent of this Article 11. 11.8 Intrexon Patents. Intrexon retains certain rights to prosecute and enforce certain Patents and Patent Applications licensed to Fibrocell under the Intrexon Agreement, and CCP’s rights to prosecute and enforce such Patents and Patent Applications provided under Sections 11.3 and 11.5 will be subject to such rights of Intrexon. 11.9 Change of Control. Notwithstanding anything in this Agreement to the contrary, the Patents, Patent Applications or Information owned or otherwise Controlled, as of the effective date of the Change of Control of a Party (the “Acquired Party”), by any counterparty with respect to a Change of Control (the “Acquiror”) or the Acquiror’s Affiliate, (“Acquiror Affiliate”), shall not become subject to the license grants and other requirements of this Agreement, provided that such Acquiror or Acquiror Affiliate is not an Affiliate of the Acquired Party immediately prior to the closing of such transaction(s). Any Patents, Patent Applications or Information developed, acquired or invented by an Acquiror or Acquiror Affiliate in the Field and in the Territory following closing of the Change of Control of the Acquired Party shall only become subject to the license grants and other requirements of this Agreement if they are developed, acquired or invented using the Confidential Information of the other Party and/or practicing the licenses or rights granted to the Acquired Party or Acquiror Affiliate by the other Party hereunder (whether by assumption of such licenses or rights in this Agreement or the grant of a sublicense or otherwise). 12. TRADEMARKS 12.1 Product Trademark. Subject to Section 6.2, the Product, Product packaging, promotional materials, package inserts, and labeling for the Territory will bear one or more Trademarks chosen and owned by CCP. 12.2 Trademark Prosecution and Maintenance. CCP will select Product- specific Trademarks for the Territory, will solely own such Trademarks in the Territory and will be responsible for filing, prosecuting and maintaining such Trademarks. All of the cost and expenses incurred by CCP with respect to such Product-specific Trademarks, including those incurred in connection with the selection, preparation, filing, prosecution, and maintenance of Trademarks used in Commercialization of the Product, filing and maintenance fees paid to governmental authorities, and the costs of litigation (enforcement or defense) or other proceedings, under such Trademarks, including fees and expenses paid to outside counsel, will be borne by CCP. 33 US-DOCS\106669270.9


 
13. REPRESENTATIONS, WARRANTIES AND COVENANTS 13.1 The Parties’ Representations and Warranties. Fibrocell and CCP (each a “Representing Party”) each hereby represents and warrants to each other as of the Effective Date that: (a) it has the full corporate or limited liability company power, authority to enter into this Agreement and to carry out the provisions hereof; (b) this Agreement has been duly executed and delivered on behalf of such Representing Party and constitutes a legal, valid and binding obligation of such Representing Party and is enforceable against it in accordance with its terms, except as enforcement may be affected by bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity; (c) it has taken all corporate or limited liability company action, as the case may be, necessary to authorize the execution, delivery and performance of this Agreement; (d) all necessary consents, approvals and authorizations of all Regulatory Authorities and other Third Parties required to be obtained by such Representing Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained; (e) the execution and delivery of this Agreement and the performance of such Representing Party’s obligations hereunder (i) do not conflict with or violate any requirement of Applicable Law or any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Representing Party, as applicable, in any material way, and (ii) do not conflict with, violate, or breach or constitute a default or require any consent under, any Applicable Law or any contractual obligation (including, with respect to Fibrocell as the Representing Party, the Intrexon Agreement) or court or administrative order by which such Representing Party is bound; (f) the Representing Party is duly organized, validly existing and in good standing under the laws of its jurisdiction of organization, and has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted; (g) all of Representing Party’s employees, officers, contractors and consultants who (i) develop intellectual property relating to this Agreement or the Product have executed agreements requiring assignment to such Representing Party of all inventions made during the course of and as a result of their association with such Representing Party and (ii) have access to confidential information of the Representing Party relating to this Agreement or the Product have executed agreements requiring each such employee, officer, contractor and consultant to maintain as confidential the Confidential Information of such Representing Party; and 34 US-DOCS\106669270.9


 
(h) neither it nor its Affiliates nor any of their respective employees, officers, agents, or, to the knowledge of the Representing Party, independent contractors who have rendered services relating to this Agreement or the Product: (i) has ever been suspended or debarred, or convicted of a crime for which an entity or person could be suspended or debarred, under 21 U.S.C. Section 335a, (ii) has ever been included in the List of Excluded Individuals/Entities maintained by the HHS Office of Inspector General pursuant to 42 U.S.C. §§ 1320a-7, 13955ccc, 1320c-5 and regulations promulgated thereunder; (iii) has ever been under indictment for a crime for which a person or entity could be excluded, suspended or debarred with respect to any of the foregoing; or (iv) is or has ever been otherwise ineligible to participate in any healthcare reimbursement or procurement program in the Territory ((i)-(iv), collectively, “Debarred or Excluded”). 13.2 Additional Representations and Warranties of Fibrocell. Fibrocell hereby represents and warrants to CCP as of the Effective Date that: (a) Fibrocell has title to Patents and Patent Applications that are (i) solely owned by Fibrocell and (ii) included within the Fibrocell Patent Rights; and the Fibrocell Patent Rights solely owned by Fibrocell are free and clear of any liens, charges, encumbrances, or judgments in the Field; (b) Fibrocell is entitled to grant the rights and licenses granted to CCP under this Agreement, and is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency, that restricts it in any way from granting to CCP the rights and licenses as set forth in this Agreement; (c) the Patents and Patent Applications listed in Exhibit 1.42 are all of the Patents and Patent Applications Controlled by Fibrocell that are necessary for Exploiting the Product in the Field as the Product is being Exploited, or is proposed to be Exploited, as of the Effective Date; (d) except for the license grants in Section 2.1, neither Fibrocell nor any of its Affiliates have assigned, transferred, conveyed, granted, or otherwise encumbered any right, title or interest in or to the Fibrocell Patent Rights or the Fibrocell Know-How that would conflict with or interfere with any of the rights or licenses granted to CCP hereunder; (e) there are no judgments or settlements against Fibrocell or material amounts owed by Fibrocell (other than amounts owed in the ordinary course of business or amounts owed as royalties or milestones under the Intrexon Agreement) with respect to the Fibrocell Patent Rights or the Fibrocell Know-How; and Fibrocell has received no written notice of any threatened or pending actions, suits, judgments, settlements, or claims against Fibrocell that, if determined adversely to Fibrocell, would have an adverse effect upon (i) its ability to grant to CCP the licenses and rights granted under this Agreement, (ii) the ability of CCP to utilize the Fibrocell Patent Rights and the Fibrocell Know-How pursuant to this Agreement, or (iii) Fibrocell’s right to enter into and perform its obligations under this Agreement; (f) no validity, infringement or freedom-to-operate opinions have been prepared by Fibrocell or its Affiliates, or on behalf of Fibrocell or its Affiliates by outside 35 US-DOCS\106669270.9


 
counsel, pertaining to the Product, any components thereof, or methods of use or manufacture thereof; (g) to Fibrocell’s knowledge, there is no material prior art or any other fact that would likely render the claims in the Fibrocell Patents issued as of the Effective Date unpatentable, invalid, or unenforceable in whole or in part; all inventors of any inventions included within the Fibrocell Patent Rights or Fibrocell Know-How Controlled by Fibrocell as of the Effective Date have assigned their entire right, title, and interest in and to such inventions and the corresponding Patent rights to Fibrocell or the Third Party licensor of such rights to Fibrocell; and to Fibrocell’s knowledge, no person, other than those persons named as inventors on any Fibrocell Patent Rights, is, or has alleged to Fibrocell to be, an inventor of the invention(s) claimed in such Fibrocell Patent Rights; and with respect to all Fibrocell Patent Rights prosecuted or solely owned by Fibrocell: (i) each has been prosecuted in material compliance with all applicable rules, policies, and procedures of the applicable patent office and (ii) each is subsisting and in good standing; (h) Fibrocell is in compliance in all material respects with any agreement between Fibrocell and a Third Party relating to the practice of the Fibrocell Patent Rights in the Field, including the Intrexon Agreement, and all such agreements are in full force and effect; (i) Fibrocell has no knowledge of any infringement by any Third Party of any of the Fibrocell Patent Rights or misappropriation of the Fibrocell Know-How; (j) Fibrocell has sufficient legal and/or beneficial title under its intellectual property rights necessary for the purposes contemplated under this Agreement and to grant the licenses contained in this Agreement; Intrexon has not notified Fibrocell of any breach of the Intrexon Agreement by Fibrocell or any other basis for termination of the Intrexon Agreement; and Fibrocell has obtained, prior to the Effective Date, the consent of Intrexon to enter into this Agreement and to grant to CCP a sublicense under the rights licensed by Intrexon to Fibrocell as set forth in Section 2.1; (k) all Patents and Patent Applications in which Fibrocell has an ownership interest as of the Effective Date that claim a product, method, apparatus, material, manufacturing process or other technology necessary to develop, make, use, sell, offer for sale, import or export the Product in the Field and in or for the Territory are solely owned by Fibrocell as of the Effective Date; (l) to Fibrocell’s knowledge, the Fibrocell Patent Rights and the Fibrocell Know-How do not include any trade secrets that have been misappropriated from any Third Party or obtained in breach of any contractual obligation of Fibrocell or its employees to a Third Party; (m) to Fibrocell’s knowledge, the Exploitation of the Product in the Field in the Territory as the Product is being Exploited or are proposed to be Exploited as of the Effective Date will not infringe or has infringed any issued claim of any Patent rights owned or otherwise controlled by a Third Party; and Fibrocell is not aware of any pending or threatened (in 36 US-DOCS\106669270.9


 
writing) litigation nor has Fibrocell received any written communications alleging that Fibrocell has violated or would violate, through the manufacture, import and/or sale of the Product hereunder, or by conducting its obligations under this Agreement as currently proposed under this Agreement, any rights including intellectual property rights of any Third Party; (n) Fibrocell has made available to CCP any material written communications received from any Regulatory Authority with respect to obtaining Regulatory Approval for the Product; (o) Fibrocell has engaged legal counsel and, together with such counsel, has reviewed and evaluated this Agreement and the transactions contemplated herein in light of (i) Section 271 of the Delaware General Corporation Law and (ii) it’s outstanding debt instruments, warrants to purchase shares of its common stock and other equity instruments, and has determined, upon advice of such counsel, that the entry into this Agreement and consummation of the transactions contemplated herein (x) do not require the vote of Fibrocell’s stockholders under Section 271 of the Delaware General Corporation Law, nor (y) necessitate the consent of any holder of Fibrocell’s debt instruments, warrants to purchase shares of its common stock or other equity instruments, nor result in a default or breach of any of the foregoing; and (p) to Fibrocell’s knowledge, Fibrocell has obtained all material licenses, authorizations, and permissions necessary under Applicable Law for performing its obligations under this Agreement and all such licenses, authorizations, and permissions are in full force and effect. 13.3 Covenants of the Parties. Each Party hereby covenants to the other Party that during the term of this Agreement: (a) such Party will perform its obligations under this Agreement in compliance with all material Applicable Laws; (b) such Party will not enter into any agreement with any Third Party that will conflict with the rights granted to the other Party under this Agreement; (c) all employees and consultants of such Party or its Affiliates working under this Agreement will be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof; (d) such Party will not knowingly employ (or use any subcontractor or consultant that employs) any individual or entity that is Debarred or Excluded, or any individual who or entity which is the subject of an FDA debarment investigation or proceeding, in the conduct of its activities under this Agreement. If during the term of this Agreement, such Party has reason to believe that it or any of its Affiliates or any of their respective employees, officers, independent contractors, or agents rendering services relating to this Agreement or the Product satisfies or is reasonably likely to be Debarred or Excluded, then such Party will immediately notify the other Party of the same in writing; and 37 US-DOCS\106669270.9


 
(e) such Party will maintain, all material licenses, authorizations, and permissions necessary under Applicable Law for performing its obligations under this Agreement. 13.4 Covenants of Fibrocell Fibrocell covenants to CCP that during the term of this Agreement Fibrocell will: (a) maintain the Intrexon Agreement in full force and effect with respect to Exploitation of the Product in or for the Territory in accordance with its terms, and notify CCP if it materially breaches the Intrexon Agreement, if Intrexon or any Intrexon affiliate alleges that Fibrocell has materially breached the Intrexon Agreement or if Fibrocell becomes aware of any circumstance that is reasonably likely to lead to such an allegation or breach, and in the event of such a material breach, alleged material breach or circumstance, (i) Fibrocell shall have the first right to cure such breach, alleged breach or circumstance, and (ii) if Fibrocell elects not to cure such breach, alleged breach or circumstance, CCP shall have the right to cure such breach, alleged breach or circumstance to the extent necessary to avoid forfeiture by, or a material adverse effect on, any material rights of CCP under the Intrexon Agreement, including any license or sublicense thereunder, and CCP may offset its reasonable costs and expenses incurred in performing such cure against the milestone payments and profit sharing payments payable under Article 9; (b) (i) exercise and enforce its rights and Intrexon’s obligations under the Intrexon Agreement that relate to the prosecution, maintenance, enforcement or defense of, or is reasonably likely to adversely affect in any material respect the rights sublicensed by Fibrocell to CCP under, the Fibrocell Patents owned by Intrexon, including pursuant to Sections 6.2(c) and 6.3(b) of the Intrexon Agreement (such rights and obligations, the “Intrexon Rights”) to the extent that a failure to do so would reasonably be expected to have a material adverse effect on CCP’s rights or interests under this Agreement; (ii) provide CCP with reasonable advance, written notice prior to exercising or enforcing any Intrexon Right (including rights of consultation or participation), or electing to forego such exercise or enforcement; and (iii) use good faith efforts to obtain Intrexon’s consent to the attendance and participation of a CCP representative at, and in any event shall give CCP reasonable advance written notice prior to, any material meetings, conferences and discussions scheduled between Intrexon and Fibrocell at which any matters relevant to an Intrexon Right will be discussed; (c) comply with its material covenants and obligations under the Intrexon Agreement; (d) not terminate, amend or waive any right under the Intrexon Agreement as it relates to Exploitation of the Product in or for the Territory, without CCP’s prior written consent; (e) not transfer, delegate, grant any interest in or assign to any Third Party, in whole or in part, the Intrexon Agreement as it relates to Exploitation of the Product in or for the Territory, without CCP’s prior written consent; 38 US-DOCS\106669270.9


 
(f) not terminate, amend, waive any right under, or transfer, delegate, grant any interest in or assign to any Third Party, in whole or in part, the Intrexon Agreement as it relates to Exploitation of the Product outside the Territory, in a manner that would reasonably be expected to increase Development Costs or reduce Net Sales in or for the Territory; (g) keep CCP reasonably informed as to the activities of the JSC (as defined under the Intrexon Agreement) and any other committee or subcommittee thereunder with respect to Exploitation of the Product in or for the Territory, and provide CCP a meaningful opportunity to review and comment on proposed actions or decisions thereof, and act or withhold action consistent with such comments; and (h) not assign, transfer, convey, grant, or otherwise encumber any right, title or interest in or to the Fibrocell Patent Rights or the Fibrocell Know-How, in a manner that would conflict with the rights granted to CCP under this Agreement. 13.5 Covenant of CCP. CCP hereby covenants to Fibrocell that during the term of this Agreement it will not conduct Development of the Product for any indication other than the Initial Indication without Fibrocell’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. 14. MUTUAL INDEMNIFICATION AND INSURANCE 14.1 Fibrocell’s Right to Indemnification. CCP will indemnify, defend and hold harmless each of Fibrocell and its Affiliates and their respective successors, assigns, directors, officers, employees, independent contractors and agents, from and against any and all liabilities, damages, losses, settlements, penalties, fines, costs and expenses, including reasonable attorneys’ fees and litigation costs (any of the foregoing to be referred to herein as “Damages”) of whatever kind or nature (but not including taxes) arising from any Third Party demand, investigation, claim, action or suit in the Territory to the extent based on (a) any act, whether of omission or commission, by CCP (or its Affiliates, Sublicensees or any of their respective directors, officers, employees, independent contractors or agents) with respect to its failure to properly discharge or perform its areas of responsibility under this Agreement, including the Commercialization of the Product by CCP; (b) the gross negligence or willful or intentional misconduct of CCP, its Affiliates or any of its Sublicensees or their respective directors, officers, employees, independent contractors or agents under this Agreement; (c) a material breach by CCP of any term of this Agreement; (d) a material breach by CCP of any obligation, representation, warranty or covenant hereunder; or (e) a violation of Applicable Law in the performance of its duties under this Agreement by CCP, its Affiliates or any of its Sublicensees or their respective directors, officers, employees, independent contractors or agents, except in each case to the extent Fibrocell has an obligation to indemnify CCP and its Affiliates pursuant to Section 14.2. 14.2 CCP’s Right to Indemnification. Fibrocell will indemnify, defend and hold harmless each of CCP and its Affiliates and their respective successors, assigns, directors, officers, employees, independent contractors and agents, from and against any and all Damages of whatever kind or nature (but not including taxes) arising from any Third Party demand, investigation, claim, action or suit in the Territory to the extent based on (a) any act, whether of 39 US-DOCS\106669270.9


 
omission or commission, by Fibrocell (or its Affiliates or any of their respective directors, officers, employees, independent contractors or agents) with respect to its failure to properly discharge or perform its areas of responsibility under this Agreement, including the Development of Product, the Manufacture and supply of the Product (including any defect or alleged defect in the Product provided pursuant to this Agreement or any injury or death of any person arising out of or related to the Product provided pursuant to this Agreement), the conduct of Clinical Trials by Fibrocell; (b) Fibrocell’s Exploitation of the Product outside the Field or outside the Territory; (c) the gross negligence or willful or intentional misconduct of Fibrocell, its Affiliates or any of its Sublicensees or any of their respective directors, officers, employees, independent contractors or agents under this Agreement; (d) a material breach by Fibrocell of any term of this Agreement or the Intrexon Agreement; (e) a material breach by Fibrocell of any obligation, representation, warranty or covenant hereunder; (f) a violation of Applicable Law in the performance of its duties under this Agreement by Fibrocell, its Affiliates or any of its Sublicensees or their respective directors, officers, employees, independent contractors or agents; or (g) Fibrocell’s or its Affiliates’ or Sublicensees’ use of or reference to any data, information, Regulatory Approvals, regulatory filings or regulatory documentation provided by CCP or generated by or on behalf of Fibrocell under this Agreement, except in each case to the extent CCP has an obligation to indemnify Fibrocell and its Affiliates pursuant to Section 14.1. 14.3 Process for Indemnification. A Party’s obligation to defend, indemnify and hold harmless the other Party under this Article 14 will be conditioned upon the following: (a) A Party seeking indemnification under this Article 14 (the “Indemnified Party”) will give prompt written notice of the claim to the other Party (the “Indemnifying Party”); provided, however, that failure to so notify shall not preclude the Indemnified Party’s right to indemnification hereunder unless the Indemnifying Party is actually prejudiced by such failure. (b) Each Party will furnish promptly to the other, copies of all papers and official documents received in respect of any Damages. The Indemnified Party will cooperate as requested by the Indemnifying Party in the defense against any Damages. (c) With respect to any Damages relating solely to the payment of money damages and which will not result in the Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnified Party under this Article 14, the Indemnifying Party will have the sole right to defend, settle or otherwise dispose of such Damages, on such terms as the Indemnifying Party, in its sole discretion, will deem appropriate. (d) With respect to Damages relating to all other matters, the Indemnifying Party will have the sole right to control the defense of such matter, provided that the Indemnifying Party will obtain the written consent of the Indemnified Party, which consent will not be unreasonably withheld or delayed, prior to ceasing to defend, settling or otherwise disposing of any Damages if as a result thereof (i) the Indemnified Party would become subject to injunctive or other equitable relief or any remedy other than the payment of money by the Indemnifying Party or (ii) the business of the Indemnified Party would be adversely affected. 40 US-DOCS\106669270.9


 
(e) The Indemnifying Party will not be liable for any settlement or other disposition of Damages by the Indemnified Party which is reached without the written consent of the Indemnifying Party, which consent will not be unreasonably withheld, conditioned or delayed, it being understood that if such consent is withheld, the Indemnifying Party will be responsible for the amount of damages or increased costs and expenses attributable to such failure to give consent. 14.4 Insurance. During the term of this Agreement and for five (5) years thereafter, each Party will maintain, at its sole expense, clinical trial and product liability insurance relating to the Product that is comparable in type and amount to the insurance customarily maintained by such Party with respect to similar prescription pharmaceutical products that are marketed, distributed and sold in the Territory. 15. LIMITATION OF LIABILITY AND EXCLUSION OF DAMAGES; DISCLAIMER OF WARRANTY 15.1 EXCEPT IN THE CASE OF A BREACH OF ARTICLE 16, AND WITHOUT LIMITING THE PARTIES’ OBLIGATIONS UNDER ARTICLE 14, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING DAMAGES RESULTING FROM LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE HEREUNDER. 15.2 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY PROVIDES ANY WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, REGARDING THE PRODUCT USED IN PRECLINICAL STUDIES OR CLINICAL TRIALS OR FOR COMMERCIAL USE, AND EACH PARTY HEREBY DISCLAIMS ALL OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS AND IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND FREEDOM FROM INFRINGEMENT OF THIRD PARTY RIGHTS. 16. CONFIDENTIALITY 16.1 Confidentiality; Exceptions. Each Party will maintain in confidence all Information and materials of the other Party disclosed or provided to it by the other Party (either pursuant to this Agreement or the Confidential Disclosure Agreement entered into by the Parties dated October 24, 2018 (the “Confidential Disclosure Agreement”)), to the extent relating to this Agreement or the Products or the Exploitation thereof (together with all embodiments thereof, the “Confidential Information”). Confidential Information also includes Information regarding intellectual property and confidential or proprietary Information of Third Parties. In addition, and notwithstanding the foregoing, if under Article 11 Information constituting inventions and discoveries are to be owned by one Party, such Information will be deemed to be Confidential Information of such Party, even if such Information is initially generated and disclosed by the other Party. The Fibrocell Know-How and the terms and conditions of this 41 US-DOCS\106669270.9


 
Agreement and the Confidential Disclosure Agreement will be deemed Confidential Information of both Parties. Notwithstanding the foregoing the obligations of confidentiality and limited use set forth herein will not apply to any portion of Information or materials that the receiving Party can demonstrate by contemporaneous written records was (a) known to the general public at the time of its disclosure to the receiving Party, or thereafter became generally known to the general public, other than as a result of actions or omissions of the receiving Party or anyone to whom the receiving Party disclosed such Information; (b) known by the receiving Party prior to the date of disclosure by the disclosing Party; (c) disclosed to the receiving Party on an unrestricted basis from a source unrelated to the disclosing Party and not under a duty of confidentiality to the disclosing Party; or (d) independently developed by the receiving Party by personnel that did not have access to or use of Confidential Information of the disclosing Party. Any combination of features or disclosures will not be deemed to fall within the foregoing exclusions merely because individual features are published or known to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation thereof are published or known to the general public or are in the rightful possession of the receiving Party. 16.2 Degree of Care; Permitted Use. Each Party will take reasonable steps to maintain the confidentiality of the Confidential Information of the other Party, which steps will be no less protective than those steps that such Party takes to protect its own Information and materials of a similar nature, but in no event less than a reasonable degree of care. Except to the extent expressly permitted under this Agreement, neither Party will use or permit the use of any Confidential Information of the other Party except for the purposes of carrying out its obligations or exercising its rights under this Agreement or the Confidential Disclosure Agreement, and neither Party will copy any Confidential Information of the other Party except as may be reasonably useful or necessary for such purposes. All Confidential Information of a Party, including all copies and derivations thereof, is and will remain the sole and exclusive property of the disclosing Party and subject to the restrictions provided for herein. Except to the extent expressly permitted under this Agreement, neither Party will disclose any Confidential Information of the other Party other than to those of its and Affiliates’ and Sublicensees’ directors, officers, employees, licensors, independent contractors, permitted assignees, agents and external advisors that are directly concerned with the carrying out of this Agreement, on a strictly applied “need to know” basis, and that are subject to confidentiality and non-use obligations at least as stringent as the confidentiality and non-use obligations provided for in this Article 16. Except to the extent expressly permitted under this Agreement, the receiving Party may not use Confidential Information of the other Party in applying for Patents or securing other intellectual property rights without first consulting with, and obtaining the written approval of, the other Party (which approval will not be unreasonably withheld or delayed). 16.3 Permitted Disclosures. The obligations of Sections 16.1, 16.2, and 17.1 will not apply to the extent that the receiving Party is required to disclose Information pursuant to (a) an order of a court of competent jurisdiction, (b) Applicable Laws, (c) regulations or rules of a securities exchange, (d) requirement of a governmental agency for purposes of obtaining approval to test or market the Product, (e) disclosure of Information to a Patent office for the purposes of filing a Patent Application as permitted in this Agreement, (f) disclosure on a need- to-know basis to any bona fide potential or actual investor, investment banker, acquirer, 42 US-DOCS\106669270.9


 
acquisition target, merger partner, licensee, licensor, or other potential or actual financial or strategic partner; provided that in connection with such disclosure, the disclosing Party will use reasonable efforts to inform each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential Information as confidential, or (g) the exercise or enforcement by each Party of its rights granted to it under this Agreement or its retained rights, including the Exploitation of the Product, and such Third Party agrees to confidentiality and non-use obligations at least as stringent as those specified for in this Article 16; provided that the receiving Party will provide prior written notice thereof to the disclosing Party and sufficient opportunity for the disclosing Party to review and comment on such required disclosure and request confidential treatment thereof or a protective order therefor. 16.4 Irreparable Injury. The Parties acknowledge that either Party’s breach of this Article 16 would cause the other Party irreparable injury for which it would not have an adequate remedy at law. In the event of a breach, the nonbreaching Party may seek injunctive relief, whether preliminary or permanent, in addition to any other remedies it may have at law or in equity, without necessity of posting a bond. 16.5 Return of Confidential Information. Each Party will return or destroy, at the other Party’s instruction, all Confidential Information of the other Party in its possession upon termination or expiration of this Agreement, except any Confidential Information that is necessary to allow such Party to perform or enjoy any of its rights or obligations that expressly survive the termination or expiration of this Agreement. 16.6 Survival of Obligations. The obligations of confidentiality and limited use contained in this Article 16 will survive and continue through the term of this Agreement and for a period of ten (10) years thereafter; provided that with respect to Confidential Information comprising a trade secret of a Party, such obligations will continue for as long as such Confidential Information qualifies as a trade secret under Applicable Law. 17. PUBLICITY 17.1 Public Disclosure. The Parties agree that the initial public announcement of the execution of this Agreement will be in the form of a mutually agreed upon press release that describes the nature and scope of the collaboration including its aggregate value (the “Initial Public Disclosure”). In connection with the issuance of such press release, each Party will also be permitted to make any filings required under Applicable Law, including filings with the U.S. Securities and Exchange Commission to report the execution of this Agreement. During the term of this Agreement, in all cases other than the announcement set forth in the Initial Public Disclosure, each Party will submit to the other Party (the “Non-Publishing Party”) for review and approval all proposed press releases, academic, scientific and medical publications and public presentations relating to the Product that have not been previously disclosed. Such review and approval will be conducted for the purposes of preserving intellectual property protection and determining whether any portion of the proposed publication or presentation containing the Confidential Information of the Non-Publishing Party should be modified or deleted, and (in the case of a disclosure that Fibrocell wishes to make) to determine whether such disclosure is in the best interests of the Parties in connection with the Development of the Product (such determination to be made in CCP’s reasonable discretion). Written copies of such proposed 43 US-DOCS\106669270.9


 
publications and presentations (other than press releases) will be submitted to the Non- Publishing Party no later than sixty (60) days (or, if less, as far in advance as is reasonably practicable) before submission for publication or presentation; provided that, for general disclosure of program status to investors or analysts, or in public conference or earnings calls (“General Disclosure”) such sixty (60) day period will be shortened to ten (10) business days (or, if less, as far in advance as is reasonably practicable). Subject to Applicable Law, written copies of proposed press releases will be submitted to the Non-Publishing Party no later than seventy-two (72) hours (or, if less, as far in advance as is reasonably practicable) before release. The Non-Publishing Party will provide its comments, if any, and (if it so chooses) its approval within (a) two (2) business days, in the case of a press release, and (b) ten (10) business days of its receipt of any other written copy. With respect to matters other than press releases, the review period may be extended for an additional thirty (30) days, or for General Disclosures ten (10) business days, in the event the Non-Publishing Party can demonstrate reasonable need for such extension, including the preparation and filing of Patent Applications. This period may be further extended by mutual written agreement of the Parties. Fibrocell and CCP will each comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publications. 17.2 Use of Marks. Neither Party will use any Trademark owned or controlled by the other Party or any derivation of the other Party’s name without the advance express written consent of the other Party, which consent may be granted or withheld in the other Party’s sole discretion. 18. TERM AND TERMINATION 18.1 Term. The term of this Agreement will commence as of the Effective Date and, unless sooner terminated as provided in this Article 18, will continue in effect until the later of (a) expiration of the last to expire Valid Claim of any Fibrocell Patent Rights in the Territory, or (b) forty (40) years from the date of Initial BLA Approval. Upon expiration of this Agreement, the licenses granted to CCP hereunder will be royalty-free and fully paid-up. 18.2 Termination by CCP. (a) CCP will have the right to terminate this Agreement at will upon one hundred eighty (180) days’ prior written notice. (b) CCP will have the right to terminate this Agreement, at any time, upon one hundred eighty (180) days’ prior written notice to Fibrocell in the event (i) CCP determines, in its reasonable discretion, that further Development or Commercialization of Products is not commercially viable, or (ii) that CCP determines that Development or Commercialization of Products must be terminated because of safety issues outside of CCP’s reasonable control (either of (i) or (ii), an “Unanticipated Development”). If CCP terminates this Agreement for an Unanticipated Development, then CCP and Fibrocell will continue to bear their respective share of noncancellable costs and expenses becoming due after the effective date of such termination, to the extent such costs and expenses were set forth in a relevant Plan; provided that the Parties will use reasonable efforts to minimize expenditures after the effective date of such termination. Upon request by Fibrocell, CCP will provide documentation to support 44 US-DOCS\106669270.9


 
its determination of the occurrence of an Unanticipated Development and meet with Fibrocell upon request to explain the basis for such determination. 18.3 Termination for Material Breach. If either Party (the “Non-Breaching Party”) believes the other Party (the “Breaching Party”) is in material breach of a material obligation under this Agreement, it may give notice of such breach to the Breaching Party, and the Breaching Party will have sixty (60) days in which to remedy such breach, or thirty (30) days in the case of breach (whether material or not) of any payment obligation hereunder. Such sixty (60) day period will be extended in the case of a breach not capable of being remedied in such sixty (60) day period so long as the Breaching Party uses diligent efforts to remedy such breach and is pursuing a course of action that, if successful, will effect such a remedy, but in no event shall a Party have more than one hundred twenty (120) days to remedy such breach. If such alleged breach is not remedied in the time period set forth above, the Non-Breaching Party will be entitled, without prejudice to any of its other rights conferred on it by this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement upon written notice to the Breaching Party. In the event of a dispute regarding any payments due and owing hereunder, all undisputed amounts will be paid when due, and the balance, if any, will be paid promptly after settlement of the dispute, including any accrued interest thereon. Notwithstanding the foregoing, if the allegedly breaching Party disputes in good faith the existence or materiality of such breach and provides notice to the other Party of such dispute within such cure period, such other Party will not have the right to terminate this Agreement in accordance with this Section 18.3 unless and until it has been determined in accordance with Section 19.10 that this Agreement was materially breached by the allegedly breaching Party and failed to cure such breach within the applicable cure period. It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement will remain in effect and the Parties will continue to perform all of their respective obligations hereunder. The Parties further agree that any payments that are made by one Party to the other Party pursuant to this Agreement pending resolution of the dispute will be promptly refunded if a court determines pursuant to Section 19.10 that such payments are to be refunded by one Party to the other Party 18.4 Termination upon Insolvency. Either Party may terminate this Agreement if, at any time, the other Party: (a) files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets; (b) proposes a written agreement of composition or extension of its debts; (c) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition will not be dismissed within forty-five (45) days after the filing thereof; (d) passes a resolution for its winding up or proposes to be or is a party to any dissolution or liquidation; or (e) if the other Party will make an assignment for the benefit of its creditors. 18.5 Termination by CCP pursuant to Section 18.2 or Fibrocell pursuant to Section 18.3 or 18.4. In the event that CCP terminates this Agreement under Section 18.2 or Fibrocell terminates this Agreement under Section 18.3 or 18.4, then, as of the effective date of such termination, subject to the rights of any Sublicensee pursuant to Section 2.2(b), the following terms and conditions will apply: 45 US-DOCS\106669270.9


 
(a) The license granted to CCP under Section 2.1 will terminate and all rights with respect thereto will revert in their entirety to Fibrocell. (b) Fibrocell shall have the first right to prosecute, maintain and enforce the Joint Patent Rights to the extent they claim the Product. If Fibrocell decides not to, or to cease, prosecution, maintenance or enforcement of any such Joint Patent Right, Fibrocell shall provide prompt notice to CCP of such decision (but in any event no later than ninety (90) days prior to the date any filing or payment is due with respect thereto), and CCP shall have the right to assume prosecution, maintenance or enforcement thereof. Each Party shall retain its right to exploit the Joint Patent Rights to the extent they do not claim the Product in accordance with their ownership interest therein, and Section 11.3(a)(iii) will survive and apply with respect thereto. (c) CCP shall grant and hereby grants to Fibrocell, a perpetual, non- exclusive, irrevocable license, with the right to grant sublicenses (including through multiple tiers of sublicenses), under the Patents, Patent Applications and Information owned or controlled by CCP to the extent they claim the Exploitation of Product, in accordance with the applicable Regulatory Approval for the Product as of the effective date of such termination. CCP shall, as soon as practicable after such termination, transfer to Fibrocell, at Fibrocell’s request and at CCP’s cost, such Information. (d) CCP shall (i) promptly return to Fibrocell, at no cost to Fibrocell, all tangible Fibrocell Know-How and Confidential Information of Fibrocell that Fibrocell has transferred to CCP, (ii) assign and transfer to Fibrocell the Initial BLA Approval, and (iii) transfer to Fibrocell any Regulatory Approval that is obtained by or on behalf of CCP, directly or indirectly, in connection with CCP’s activities under this Agreement that is applicable solely to the Product. Any costs and expenses incurred by CCP in connection with the assignments and transfers made by CCP under this Section 18.5 shall be borne by Fibrocell. (e) If CCP has placed any purchase orders for biopsy kits or finished Product prior to termination that have not been fulfilled, Fibrocell shall fulfill such purchase orders on behalf of CCP, subject to the payment to Fibrocell of any amounts due under Article 9 with respect to such orders. (f) In consideration for Fibrocell’s use of the Information (including data) and other intellectual property rights transferred or licensed to Fibrocell by CCP under this Section 18.5, Fibrocell shall upon first commercial sale by Fibrocell, its Affiliates or licensees in the Territory pay to CCP an amount equal to five percent (5%) of Product Gross Profit in respect of sales of the Product in the Territory by Fibrocell, its Affiliates or licensees in the Initial Indication and any additional indications developed or commercialized by the Parties as of the effective date of termination. Fibrocell will keep complete and accurate records pertaining to the Net Sales of the Product and Fully Burdened Manufacturing Costs, which documents would enable CCP to confirm the accuracy of the calculations of payments made to CCP under this Section 18.5(f). The terms and conditions set forth in Sections 9.6-9.9 and Article 10, including the applicable definitions used therein, shall apply to Fibrocell with respect to such payments on Net Sales of the Product by Fibrocell, its Affiliates or licensees in the same manner they would apply to CCP prior to such termination. Following reversion of rights to Fibrocell pursuant to 46 US-DOCS\106669270.9


 
this Section 18.5, Fibrocell shall be required to use Commercially Reasonable Efforts to Develop and Commercialize the Product in the Territory. (g) Upon Fibrocell’s request, CCP will transfer to Fibrocell, and Fibrocell will have the right to use, all materials, results, analyses, reports, websites, marketing materials, technology, know-how, regulatory filings and other Information, reasonably required by Fibrocell, in whatever form developed, controlled or generated as of the effective date of such termination by or on behalf of CCP, its Affiliates or Sublicensees with respect to the Product. Additionally, CCP will grant to Fibrocell any rights of reference or access to regulatory filings necessary to practice the rights granted to it under this Section 18.5. All transfers described in this Section 18.5(g) will be at Fibrocell’s expense. (h) CCP shall cooperate with Fibrocell to facilitate an orderly transition and uninterrupted Development, Manufacturing and Commercialization of all Product, including by assigning or otherwise transferring (to the extent permissible) to Fibrocell all right, title and interest in all Third Party contracts (or portions thereof) that are assignable by CCP to the extent they are necessary for the Commercialization solely of the Product in the Territory, as reasonably requested by CCP; provided that Fibrocell shall use good faith efforts to enter into its own commercial or government contracts related thereto as soon as reasonably practicable following the effective date of such termination. (i) Except where expressly provided for otherwise in this Agreement, termination of this Agreement by CCP pursuant to Section 18.2 or by Fibrocell pursuant to Section 18.3, will not relieve the Parties of any liability, including any obligation to make payments that accrued hereunder prior to the effective date of such termination, nor preclude any Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice any Party’s right to obtain performance of any obligation to be performed hereunder. In the event of such termination, this Section 18.5 will survive in addition to others specified in Section 18.7 or otherwise in this Agreement to survive in the event of termination. 18.6 Termination by CCP Pursuant to Section 18.3 or 18.4. In the event that CCP terminates this Agreement under Section 18.3 or 18.4, then as of the effective date of such termination, the following terms and conditions will apply: (a) The license granted to CCP under Section 2.1 shall become perpetual and irrevocable, provided that CCP makes the payments payable to Fibrocell under and in accordance with Section 18.6(b) and, to the extent such license is granted under the Fibrocell Patents owned by Intrexon, such license shall be subject to the terms and conditions of the Intrexon Agreement. (b) CCP’s obligations to share in Product Gross Profit pursuant to Section 9.3 and to pay Fibrocell milestones pursuant to Section 9.5 will survive; provided that all such payments required to be paid pursuant to Sections 9.3 and 9.5 will be equitably reduced by an amount and/or a percentage commensurate with the actual economic harm suffered by CCP as a result of the material breach by Fibrocell, subject to the limitations set forth in Section 15.1. Any dispute regarding the magnitude of such payment reduction will be resolved in accordance 47 US-DOCS\106669270.9


 
with Section 19.10. Following such termination, CCP shall be required to use Commercially Reasonable Efforts to Develop and Commercialize the Product in the Territory. (c) Fibrocell will, without additional consideration, assign to CCP all of its right, title and interest, if any, in and to any Product-specific Trademark filed during the course of and pursuant to this Agreement. CCP will bear, in its sole discretion, the full costs and expense of and be solely responsible for prosecuting, maintaining, enforcing and defending any Product-specific Trademark in the Territory after the effective date of termination. (d) Upon CCP’s request, Fibrocell will transfer to CCP, and CCP will have the right to use, all materials, results, analyses, reports, websites, marketing materials, technology, know-how, regulatory filings and other Information, reasonably required by CCP, in whatever form developed, controlled or generated as of the effective date of such termination by or on behalf of Fibrocell, its Affiliates or licensees with respect to the Product. Additionally, Fibrocell will grant to CCP any rights of reference or access to regulatory filings necessary to practice the rights granted to it under this Section 18.6. All transfers described in this Section 18.6(d) will be at CCP’s expense. (e) If such termination is pursuant to Section 18.3, Fibrocell will supply CCP’s or its designee’s requirements of the Product at commercially reasonable prices until the earlier of CCP’s qualification of alternate supply sources, or twenty-four (24) months after termination. (f) Surviving Rights. Except where expressly provided for otherwise in this Agreement, termination of this Agreement pursuant to Section 18.3 for Fibrocell’s breach will not relieve the Parties of any liability, including any obligation to make payments hereunder, which accrued hereunder prior to the effective date of such termination, nor preclude any Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice any Party’s right to obtain performance of any obligation. In the event of such termination, the Manufacturing and Supply Agreement, the Quality Agreement, and the following provisions of this Agreement will survive in addition to others specified in Section 18.7 or otherwise in this Agreement to survive in the event of termination: Articles 11, and 12 and Sections 2.1, 2.2, 2.5, 2.6, 5.3, 5.6 (solely to the extent that the effective date of termination is prior to the transfer of the Initial BLA Approval), 5.8–5.10, 8.2, 9.2–9.9, 13.4, and 18.6. 18.7 General Surviving Obligations. The rights and obligations set forth in this Agreement will extend beyond the expiration or termination of this Agreement only to the extent expressly provided for herein, or to the extent that the survival of such rights or obligations are necessary to permit their complete fulfillment or discharge. In the event of expiration or termination of this Agreement for any reason, the following provisions will survive in addition to others specified in this Agreement to survive in such event. Additionally, the rights and obligations of the Parties under Sections 5.9, 18.7, 18.8, 19.1, and 19.9–19.15, and Articles 1, 10, 14, 15, and 16 as of the effective date of expiration or termination date will survive the termination or expiration of this Agreement. 48 US-DOCS\106669270.9


 
18.8 Accrued Rights, Surviving Obligations. Termination or expiration of this Agreement will not relieve either Party from obligations that are expressly indicated to survive termination or expiration of this Agreement. Except as otherwise provided for in this Agreement, termination by a Party will not be an exclusive remedy, and all other remedies will be available to the terminating Party, in equity and at law. 18.9 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Fibrocell or CCP are, and will otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, will retain and may fully exercise all of their rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the United States Bankruptcy Code, the Party that is not a party to such proceeding will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non- subject Party’s possession, will be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party. 19. MISCELLANEOUS 19.1 Agency. Neither Party is, nor will be deemed to be, an employee, agent, co-venturer or legal representative of the other Party for any purpose. Neither Party will be entitled to enter into any contracts in the name of, or on behalf of the other Party, nor will either Party be entitled to pledge the credit of the other Party in any way or hold itself out as having the authority to do so. 19.2 Assignment; Change of Control. (a) Except as otherwise provided in this Agreement, neither this Agreement nor any interest hereunder will be assignable by any Party without the prior written consent of the other Party (which consent will not be unreasonably withheld or delayed); provided, however, (i) either Party, without such consent, may assign its rights and delegate its duties hereunder to an Affiliate of such Party without obtaining such consent, provided that the assigning Party agrees to remain primarily (and not secondarily or derivatively) liable for the full and timely performance by such Affiliate of all its obligations hereunder, (ii) either Party, without such consent, may assign or transfer this Agreement in connection with a Change of Control, and (iii) either Party, without such consent, may assign its rights and delegate its duties hereunder to a successor-in-interest in the sale of all or substantially all of its assets or that portion of its business to which this Agreements relates; provided that the Licensed Intellectual Property, Manufacturing and Supply Agreement, Pharmacovigilance Agreement, and any other agreement that the Parties enter into under this Agreement are also assigned or transferred to the same Third Party to which this Agreement is assigned or transferred. 49 US-DOCS\106669270.9


 
(b) This Agreement will be binding upon and inure to the successors and permitted assignees of the Parties and the name of a Party appearing herein will be deemed to include the names of such Party’s successor’s and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 19.2 will be void. 19.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 19.4 Force Majeure. Neither Party will be liable or responsible to the other Party for loss or damages, nor will it have any right to terminate this Agreement for any default or delay attributable to any event beyond its reasonable control and without its fault or negligence, including but not limited to acts of God, acts of government (including injunctions), fire, flood, earthquake, strike, lockout, labor dispute, breakdown of plant, shortage of critical equipment, loss or unavailability of manufacturing facilities or material, casualty or accident, civil commotion, acts of public enemies, acts of terrorism or threat of terrorist acts, blockage or embargo and the like (a “Force Majeure Event”); provided, however, that in each such case the Party affected will use reasonable efforts to avoid such occurrence and to remedy it promptly. The Party affected will give prompt notice of any such cause to the other Party. The Party giving such notice will thereupon be excused from such of its obligations hereunder as it is thereby disabled from performing for so long as it is so disabled and for sixty (60) days thereafter and the Party receiving notice will be similarly excused from its respective obligations which it is thereby disabled from performing; provided, however, that such affected Party commences and continues to take reasonable and diligent actions to cure such cause. Notwithstanding the foregoing, nothing in this Section 19.4 will excuse or suspend the obligation to make any payment due hereunder in the manner and at the time provided. 19.5 Notices. All notices and other communications hereunder will be in writing and will be deemed given if delivered personally or by facsimile transmission (receipt verified), mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the Parties at the following addresses (or at such other address for a Party as will be specified by like notice; provided that notices of a change of address will be effective only upon receipt thereof): If to CCP, addressed to: Castle Creek Pharmaceuticals, LLC 6 Century Blvd. Parsippany, New Jersey 07054 Attention: Greg Wujek If to Fibrocell, addressed to: Fibrocell Science, Inc. 405 Eagleview Boulevard Exton, PA 19341 50 US-DOCS\106669270.9


 
Attn: Chief Executive Officer 19.6 Amendment. No amendment, modification or supplement of any provision of this Agreement will be valid or effective unless made in writing and signed by a duly authorized officer of each Party. 19.7 Waiver. No provision of this Agreement will be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party. 19.8 Counterparts. This Agreement may be executed in counterparts, and each such counterpart hereof will be deemed to be an original instrument, but all such counterparts together will constitute but one agreement. Delivery of an executed counterpart of a signature page of this Agreement by PDF, facsimile or other electronic transmission will be effective as delivery of a manually executed original counterpart of this Agreement. 19.9 Construction. The descriptive headings of this Agreement are for convenience only, and will be of no force or effect in construing or interpreting any of the provisions of this Agreement. Except where the context otherwise requires, wherever used the singular will include the plural, the plural the singular, the use of any gender will be applicable to all genders. The terms “including” and “inclusive of” will mean “including without limitation.” The language of this Agreement will be deemed to be the language mutually chosen by the Parties and no rule of strict construction will be applied against either Party. 19.10 Governing Law. This Agreement will be governed by and interpreted in accordance with the substantive laws of the State of New York, U.S.A. without regard to its or any other jurisdiction’s laws, rules or principles that would result in the application of the laws of any jurisdiction other than the State of New York. Any disputes under this Agreement will be brought in the state or federal courts located in Manhattan or the Southern District of New York, U.S.A. The Parties irrevocably accept the exclusive jurisdiction of such courts solely and specifically for the purpose of adjudicating disputes arising out of or in connection with this Agreement and any other agreement entered into pursuant to this Agreement or in connection with this Agreement (including matters regarding the construction, interpretation and enforceability of such agreements), and in no event will any Party be deemed to have consented to such jurisdiction for any other purpose. Each Party further agrees that such courts provide a convenient forum for any such action, and waives any objections or challenges to venue with respect to such courts. 19.11 Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under Applicable Law, but if any provision of this Agreement is held to be prohibited by or invalid under Applicable Law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. In the event of such invalidity, the Parties will seek to agree on an alternative enforceable provision that preserves the original purpose of this Agreement. 51 US-DOCS\106669270.9


 
19.12 Compliance with Applicable Law. Each Party will comply with all Applicable Law in performing its obligations and exercising its rights hereunder. Nothing in this Agreement will be deemed to permit either Party to export, re-export or otherwise transfer any Information transferred hereunder or Product manufactured therefrom without complying with Applicable Law. 19.13 Entire Agreement of the Parties. This Agreement and the Exhibits attached hereto, and the Manufacturing and Supply Agreement, constitute and contain the complete, final and exclusive understanding and agreement of the Parties, and cancel and supersede any and all prior or contemporaneous negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter of this Agreement (including the Confidential Disclosure Agreement), and neither Party will be liable or bound to any other Party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein. Nothing in this Agreement, express or implied, is intended to confer upon any Party, other than the Parties and their respective successors and assigns, any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided herein. To the extent that anything set forth in an exhibit attached hereto conflicts with the terms of this Agreement, the terms of this Agreement will control. 19.14 Performance by Affiliates. (a) Fibrocell recognizes that CCP may perform some or all of its obligations under this Agreement through Affiliates; provided, however, that CCP will remain responsible for the performance by its Affiliates and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. (b) CCP recognizes that Fibrocell may perform some or all of its obligations under this Agreement through Affiliates; provided, however, that Fibrocell will remain responsible for the performance of its Affiliates and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. 19.15 Non-Solicitation. While the Parties are performing research, Development and Commercialization activities under this Agreement and for a period of two (2) years thereafter, neither Party will, without the express written consent of the other Party, recruit, solicit or induce any employee of the other Party to terminate his or her employment with such other Party. The foregoing provision will not, however, restrict either Party or its Affiliates from advertising employment opportunities in any manner that does not directly target the other Party or its Affiliates or from hiring any persons who respond to such generalized public advertisements. [REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK] 52 US-DOCS\106669270.9


 
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Effective Date by their duly authorized representatives as set forth below: CASTLE CREEK PHARMACEUTICALS, LLC By: /s/ Gregory F. Wujek Name: Gregory F. Wujek Title: Chief Executive Officer FIBROCELL SCIENCE, INC. By: /s/ John M. Maslowski Name: John M. Maslowski Title: President and Chief Executive Officer 53 US-DOCS\106669270.9


 
EXHIBIT 1.41 FIBROCELL KNOW-HOW [**] US-DOCS\106669270.9


 
EXHIBIT 1.42 FIBROCELL PATENT RIGHTS [**] US-DOCS\106669270.9


 
EXHIBIT 1.45 FULLY BURDENED MANUFACTURING COSTS [**] US-DOCS\106669270.9


 
EXHIBIT 4.2(a)(i) DEVELOPMENT PLAN [**] US-DOCS\106669270.9


 
EXHIBIT 4.2(a)(ii) DEVELOPMENT BUDGET [**] US-DOCS\106669270.9


 
EXHIBIT 4.5(a) APPROVED SUBCONTRACTORS [**] US-DOCS\106669270.9


 


Exhibit 31
 
OFFICER’S CERTIFICATION PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, John M. Maslowski certify that:
1.  I have reviewed this Quarterly Report on Form 10-Q of Fibrocell Science, Inc.;
2.  Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made not misleading with respect to the period covered by this report;
3.  Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.  The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date:
August 14, 2019
By:
/s/ John M. Maslowski
 
John M. Maslowski
 
President and Chief Executive Officer
 
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)





Exhibit 32
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2019 of Fibrocell Science, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John M. Maslowski, President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
 
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78o(d)); and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date:
August 14, 2019
By:
/s/ John M. Maslowski
 
John M. Maslowski
 
President and Chief Executive Officer
 
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
 
A signed original of this written statement required by Section 906 has been provided to Fibrocell Science, Inc. and will be retained by Fibrocell Science, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.