þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
86-1032927
|
|
State of Incorporation
|
IRS Employer Identification No.
|
Large accelerated filer
|
o
|
Accelerated filer
|
þ
|
Non-accelerated filer
|
o
|
Smaller reporting company
|
o
|
PART I FINANCIAL INFORMATION
|
||||
3
|
||||
4
|
||||
5
|
||||
6
|
||||
24
|
||||
42
|
||||
43
|
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PART II
OTHER INFORMATION
|
||||
44
|
||||
44
|
||||
45
|
||||
45
|
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45 | ||||
45
|
||||
45
|
||||
46
|
March 31,
|
December 31,
|
|||||||
2016
|
2015
|
|||||||
Assets
|
||||||||
Cash and cash equivalents
|
$ | 15,667,528 | $ | 14,884,597 | ||||
Accounts receivable
|
582,714 | 630,332 | ||||||
Other receivables
|
316,993 | 271,344 | ||||||
Inventory
|
486,348 | 390,886 | ||||||
Prepaid expenses
|
644,250 | 367,050 | ||||||
Taxes recoverable
|
- | 150,082 | ||||||
Total current assets
|
17,697,833 | 16,694,291 | ||||||
Investments
|
26,309,984 | 5,379,407 | ||||||
Property, plant and equipment, net
|
2,743,466 | 2,768,900 | ||||||
Goodwill
|
7,678,789 | 7,678,789 | ||||||
Intangibles, net
|
15,511,705 | 15,949,100 | ||||||
Long-term prepaid expenses and other assets
|
1,360,679 | 989,935 | ||||||
Total assets (1)
|
$ | 71,302,456 | $ | 49,460,422 | ||||
Liabilities and Stockholders' Equity
|
||||||||
Liabilities:
|
||||||||
Accounts payable
|
$ | 208,894 | $ | 260,886 | ||||
Accrued expenses
|
902,265 | 845,087 | ||||||
Taxes payable
|
32,450 | - | ||||||
Other current liabilities
|
2,026,264 | 1,913,284 | ||||||
Total current liabilities
|
3,169,873 | 3,019,257 | ||||||
Deferred tax liabilities | 3,385,545 | - | ||||||
Other non-current liabilities
|
26,311 | 76,229 | ||||||
Total liabilities (1)
|
6,581,729 | 3,095,486 | ||||||
Commitments and Contingencies (note 13)
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, par value $.001, 50,000,000 shares
|
||||||||
authorized; none issued and outstanding as of
|
||||||||
March 31, 2016 and December 31, 2015, respectively
|
- | - | ||||||
Common stock, par value $.001, 300,000,000 shares authorized;
|
||||||||
12,001,188 and 11,711,645 issued and outstanding
|
||||||||
as of March 31, 2016 and December 31, 2015, respectively
|
12,001 | 11,711 | ||||||
Additional paid in capital
|
109,940,675 | 103,807,651 | ||||||
Accumulated deficit
|
(61,548,424 | ) | (57,338,311 | ) | ||||
Accumulated other comprehensive income (loss)
|
16,316,475 | (116,115 | ) | |||||
Total stockholders' equity
|
64,720,727 | 46,364,936 | ||||||
Total liabilities and stockholders' equity
|
$ | 71,302,456 | $ | 49,460,422 |
(1)
|
The Company’s consolidated assets as of March 31, 2016 and December 31, 2015 included $5,782,741 and $6,115,073, respectively, of assets of variable interest entities, or VIEs, that can only be used to settle obligations of the VIEs. Each of the following amounts represent the balances as of March 31, 2016 and December 31, 2015, respectively. These assets include cash and cash equivalents of $588,309 and $1,821,883; accounts receivable of $190,088 and $337,345; other receivables of $137,548 and $136,621; inventory of $233,338 and $180,973; prepaid expenses of $313,399 and $250,123; property, plant and equipment, net, of $1,773,690 and $1,145,924; intangibles of $1,849,219 and $1,892,551; and long-term prepaid expenses and other assets of $697,150 and $349,653. The Company’s consolidated liabilities as of March 31, 2016 and December 31, 2015 included $1,488,474 and $1,478,160, respectively, of liabilities of the VIEs whose creditors have no recourse to the Company. These liabilities include accounts payable of $77,069 and $38,004; other payables of $882,900 and $914,817; payroll accrual of $517,671 and $464,510; and other non-current liabilities of $10,834 and $60,829. See further description in Note 3, Variable Interest Entities.
|
For the Three Months Ended
|
||||||||
March 31,
|
||||||||
2016
|
2015
|
|||||||
(Note 20)
|
||||||||
Net sales and revenue
|
$ | 488,491 | $ | 603,390 | ||||
Operating expenses:
|
||||||||
Cost of sales
|
503,193 | 494,062 | ||||||
General and administrative
|
2,775,925 | 2,680,237 | ||||||
Selling and marketing
|
178,754 | 149,022 | ||||||
Research and development
|
2,398,362 | 1,455,420 | ||||||
Impairment of investments
|
- | 123,428 | ||||||
Total operating expenses
|
5,856,234 | 4,902,169 | ||||||
Operating loss
|
(5,367,743 | ) | (4,298,779 | ) | ||||
Other income (expense):
|
||||||||
Interest income
|
17,050 | 15,111 | ||||||
Other income (expense)
|
16,320 | (2,703 | ) | |||||
Total other income
|
33,370 | 12,408 | ||||||
Loss before taxes
|
(5,334,373 | ) | (4,286,371 | ) | ||||
Income taxes credit (provision)
|
1,124,260 | (800 | ) | |||||
Net loss
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | ||
Other comprehensive income (loss):
|
||||||||
Cumulative translation adjustment
|
16,073 | 19,609 | ||||||
Unrealized gain (loss) on investments, net of tax of $4,514,060 and $nil, for the three months ended march 31, 2016 and 2015, respectively
|
16,416,517 | (2,568,271 | ) | |||||
Total other comprehensive income (loss):
|
16,432,590 | (2,548,662 | ) | |||||
Comprehensive gain (loss)
|
$ | 12,222,477 | $ | (6,835,833 | ) | |||
Net loss per share :
|
||||||||
Basic
|
$ | (0.35 | ) | $ | (0.39 | ) | ||
Diluted
|
$ | (0.35 | ) | $ | (0.39 | ) | ||
Weighted average common shares outstanding:
|
||||||||
Basic
|
11,884,066 | 11,039,208 | ||||||
Diluted
|
11,884,066 | 11,039,208 |
For the Three Months Ended
|
||||||||
March 31,
|
||||||||
2016
|
2015
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | ||
Adjustments to reconcile net loss to net cash
|
||||||||
used in operating activities:
|
||||||||
Depreciation and amortization
|
671,649 | 439,242 | ||||||
Stock based compensation expense
|
1,266,063 | 1,719,458 | ||||||
Other than temporary impairment on investments
|
- | 123,428 | ||||||
Realized losses from sale of investments
|
- | 5,178 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
50,764 | (198,944 | ) | |||||
Other receivables
|
9,705 | (38,463 | ) | |||||
Inventory
|
(96,083 | ) | 94,381 | |||||
Prepaid expenses
|
(274,829 | ) | (81,602 | ) | ||||
Taxes recoverable
|
150,082 | - | ||||||
Other current assets
|
- | 110,346 | ||||||
Long-term prepaid expenses and other assets
|
(38,522 | ) | (44,340 | ) | ||||
Accounts payable
|
(51,992 | ) | (266,744 | ) | ||||
Accrued expenses
|
57,178 | 142,276 | ||||||
Advances payable to related party
|
- | (30,216 | ) | |||||
Other current liabilities
|
29,415 | 346,585 | ||||||
Taxes payable
|
32,450 | (226,055 | ) | |||||
Deferred tax liabilities | (1,128,515 | ) | - | |||||
Other non-current liabilities
|
(50,049 | ) | (213,254 | ) | ||||
Net cash used in operating activities
|
(3,582,797 | ) | (2,405,895 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Proceed from sale of investments, net of issuance cost paid
|
- | 1,480 | ||||||
Purchases of intangibles
|
- | (569,828 | ) | |||||
Purchases of assets
|
(674,736 | ) | (179,293 | ) | ||||
Net cash used in investing activities
|
(674,736 | ) | (747,641 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Net proceeds from the issuance of common stock
|
4,970,002 | 19,564,846 | ||||||
Proceeds from exercise of stock options
|
93,249 | 26,590 | ||||||
Repayment of advance from affiliate
|
- | - | ||||||
Net cash provided by financing activities
|
5,063,251 | 19,591,436 | ||||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH
|
(22,786 | ) | (63,817 | ) | ||||
INCREASE IN CASH AND CASH EQUIVALENTS
|
782,932 | 16,374,083 | ||||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
14,884,597 | 14,770,584 | ||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 15,667,529 | $ | 31,144,667 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION
|
||||||||
Cash paid for income taxes
|
$ | (4,255 | ) | $ | (226,855 | ) |
March 31,
|
December 31,
|
|||||||
2016
|
2015
|
|||||||
Assets
|
||||||||
Cash
|
$ | 588,309 | $ | 1,821,883 | ||||
Accounts receivable
|
190,088 | 337,345 | ||||||
Other receivables
|
137,548 | 136,621 | ||||||
Inventory
|
233,338 | 180,973 | ||||||
Prepaid expenses
|
313,399 | 250,123 | ||||||
Total current assets
|
1,462,682 | 2,726,945 | ||||||
Property, plant and equipment, net
|
1,773,690 | 1,145,924 | ||||||
Intangibles
|
1,849,219 | 1,892,551 | ||||||
Long-term prepaid expenses and other assets
|
697,150 | 349,653 | ||||||
Total assets
|
$ | 5,782,741 | $ | 6,115,073 | ||||
Liabilities
|
||||||||
Accounts payable
|
$ | 77,069 | $ | 38,004 | ||||
Other payables
|
882,900 | 914,817 | ||||||
Payroll accrual
|
517,671 | 464,510 | ||||||
Total current liabilities
|
$ | 1,477,640 | $ | 1,417,331 | ||||
Other non-current liabilities
|
10,834 | 60,829 | ||||||
Total liabilities
|
$ | 1,488,474 | $ | 1,478,160 |
March 31, 2016
|
December 31, 2015
|
|||||||
Raw materials
|
$ | 438,999 | $ | 357,896 | ||||
Semi-finished goods
|
14,628 | 15,346 | ||||||
Finished goods
|
32,721 | 17,644 | ||||||
$ | 486,348 | $ | 390,886 |
Three month ended | ||||||||
March 31, 2016
|
March 31, 2015
|
|||||||
Balance at the beginning of the period
|
$ | 123,848 | $ | - | ||||
Exchange difference
|
621 | - | ||||||
Balance at the end of the period
|
124,469 | - |
March 31, 2016
|
December 31, 2015
|
|||||||
Office equipment
|
$ | 59,843 | $ | 24,526 | ||||
Manufacturing equipment
|
2,712,398 | 2,680,805 | ||||||
Computer equipment
|
153,289 | 150,698 | ||||||
Leasehold improvements
|
2,207,281 | 1,417,997 | ||||||
Construction work in process
|
17,521 | 680,740 | ||||||
5,150,332 | 4,954,766 | |||||||
Less: accumulated depreciation
|
(2,406,866 | ) | (2,185,866 | ) | ||||
$ | 2,743,466 | $ | 2,768,900 |
March 31, 2016
|
Cost
|
Gross Unrealized Gains/(losses)
|
Gross Unrealized Losses more than 12 months
|
Gross Unrealized Losses less than 12 months
|
Market or Fair Value
|
|||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 251,388 | $ | - | $ | - | $ | (163,117 | ) | $ | 88,271 | |||||||||
Equity position in Arem Pacific Corporation
|
5,030,000 | 21,130,000 | - | - | 26,160,000 | |||||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713 | - | - | - | 61,713 | |||||||||||||||
Total
|
$ | 5,343,101 | $ | 21,130,000 | $ | - | $ | (163,117 | ) | $ | 26,309,984 |
December 31, 2015
|
Cost
|
Gross Unrealized Gains/(losses)
|
Gross Unrealized Losses more than 12 months
|
Gross Unrealized Losses less than 12 months
|
Market or Fair Value
|
|||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 251,388 | $ | - | $ | - | $ | (133,694 | ) | $ | 117,694 | |||||||||
Equity position in Arem Pacific Corporation
|
5,030,000 | 170,000 | - | - | 5,200,000 | |||||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713 | - | - | - | 61,713 | |||||||||||||||
Total
|
$ | 5,343,101 | $ | 170,000 | $ | - | $ | (133,694 | ) | $ | 5,379,407 |
As of March 31, 2016
|
||||||||||||||||
Fair Value Measurements at Reporting Date Using:
|
||||||||||||||||
Quoted Prices in
|
Significant Other
|
Significant
|
||||||||||||||
Active Markets for
|
Observable
|
Unobservable
|
||||||||||||||
Identical Assets
|
Inputs
|
Inputs
|
||||||||||||||
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 88,271 | $ | - | $ | 88,271 | $ | - | ||||||||
Equity position in Arem Pacific Corporation
|
26,160,000 | - | 26,160,000 | - | ||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713 | - | 61,713 | - | ||||||||||||
$ | 26,309,984 | $ | - | $ | 26,309,984 | $ | - | |||||||||
As of December 31, 2015
|
||||||||||||||||
Fair Vaue Measurements at Reporting Date Using:
|
||||||||||||||||
Quoted Prices in
|
Significant Other
|
Significant
|
||||||||||||||
Active Markets for
|
Observable
|
Unobservable
|
||||||||||||||
Identical Assets
|
Inputs
|
Inputs
|
||||||||||||||
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 117,694 | $ | - | $ | 117,694 | $ | - | ||||||||
Equity position in Arem Pacific Corporation
|
5,200,000 | - | 5,200,000 | - | ||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713 | - | 61,713 | - | ||||||||||||
$ | 5,379,407 | $ | - | $ | 5,379,407 | $ | - |
Patents & knowhow & license
|
||||||||
March 31, 2016
|
December 31, 2015
|
|||||||
Cost basis
|
$ | 17,696,601 | $ | 17,686,700 | ||||
Less: accumulated amortization
|
(2,233,936 | ) | (1,790,045 | ) | ||||
$ | 15,462,665 | $ | 15,896,655 | |||||
Software
|
||||||||
March 31, 2016
|
December 31, 2015
|
|||||||
Cost basis
|
$ | 91,407 | $ | 90,951 | ||||
Less: accumulated amortization
|
(42,367 | ) | (38,506 | ) | ||||
$ | 49,040 | $ | 52,445 | |||||
Total intangibles, net
|
$ | 15,511,705 | $ | 15,949,100 |
Years ending March 31,
|
Amount
|
|||
2017
|
$ | 1,787,942 | ||
2018
|
1,784,239 | |||
2019
|
1,777,178 | |||
2020
|
1,776,423 | |||
2021 and thereafter
|
8,385,923 | |||
$ | 15,511,705 |
Years ending March 31,
|
Amount
|
|||
2017
|
$ | 858,293 | ||
2018
|
488,490 | |||
2019
|
467,714 | |||
2020
|
452,751 | |||
2021 and thereafter
|
512,442 | |||
$ | 2,779,690 |
March 31, 2016
|
||||
Contracts for acquisition of plant and equipment being or to be executed
|
$ | 290,892 |
Number of Options
|
Weighted- Average Exercise Price
|
Weighted- Average Remaining Contractual Term (in years)
|
Aggregate Intrinsic Value
|
|||||||||||||
Outstanding at December 31, 2015
|
1,952,648 | $ | 12.42 | 7.8 | $ | 17,701,962 | ||||||||||
Grants
|
50,743 | 24.72 | ||||||||||||||
Forfeitures
|
(168,797 | ) | 23.57 | |||||||||||||
Exercises
|
(26,385 | ) | 5.58 | |||||||||||||
Outstanding at March 31, 2016
|
1,808,209 | $ | 11.83 | 7.6 | $ | 12,334,010 | ||||||||||
Vested and exercisable at March 31, 2016
|
1,009,046 | $ | 7.30 | 7.3 | $ | 11,445,587 | ||||||||||
Exercise
|
Number of Options
|
|||||||||||||||
Price
|
Outstanding
|
Exercisable
|
||||||||||||||
$ | $3.00 - $4.95 | 276,430 | 276,430 | |||||||||||||
$ | $5.00 - $9.19 | 660,654 | 493,566 | |||||||||||||
$ | $12.91 | + | 871,125 | 239,050 | ||||||||||||
1,808,209 | 1,009,046 |
For the Three Months Ended
|
|||||||||
March 31,
|
|||||||||
2016
|
2015
|
||||||||
Net loss
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | |||
Weighted average shares of common stock
|
11,884,066 | 11,039,208 | |||||||
Dilutive effect of stock options
|
- | - | |||||||
Restricted stock vested not issued
|
- | - | |||||||
Common stock and common stock equivalents
|
11,884,066 | 11,039,208 | |||||||
Net loss per basic share
|
$ | (0.35 | ) | $ | (0.39 | ) | |||
Net loss per diluted share
|
$ | (0.35 | ) | $ | (0.39 | ) |
For the Three Months Ended
|
||||||||
March 31,
|
||||||||
2016
|
2015
|
|||||||
Current:
|
||||||||
US federal
|
$ | - | $ | - | ||||
US state
|
4,255 | 800 | ||||||
Foreign
|
- | - | ||||||
Total current tax expense
|
$ | 4,255 | $ | 800 | ||||
Deferred:
|
||||||||
Federal
|
$ | (1,006,960 | ) | $ | - | |||
State
|
(121,555 | ) | - | |||||
Foreign
|
- | - | ||||||
Total deferred tax (credit) expense
|
$ | (1,128,515 | ) | $ | - | |||
Total income tax (credit) expense
|
$ | (1,124,260 | ) | $ | 800 |
March 31,
|
December 31,
|
|||||||
2016
|
2015
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carry forwards (offshore)
|
$ | 1,768,353 | $ | 1,994,281 | ||||
Net operating loss carry forwards (US)
|
2,944,292 | 2,300,322 | ||||||
Accruals (offshore)
|
207,362 | 176,859 | ||||||
Accrued compensation (US)
|
80,923 | 36,177 | ||||||
Stock-based compensation (US)
|
1,733,519 | 1,430,243 | ||||||
Investments (US)
|
1,683,237 | 1,683,237 | ||||||
Credits (US)
|
98,237 | 72,004 | ||||||
Subtotal
|
8,515,923 | 7,693,123 | ||||||
Less: valuation allowance
|
(4,714,640 | ) | (7,663,450 | ) | ||||
$ | 3,801,283 | $ | 29,673 | |||||
Deferred tax liabilities:
|
||||||||
Property and equipment
|
(1,526 | ) | (1,377 | ) | ||||
Goodwill & Intangibles
|
(89,558 | ) | (28,296 | ) | ||||
Investments (US) - other comprehensive income | (7,095,744 | ) | - | |||||
Subtotal
|
(7,186,828 | ) | (29,673 | ) | ||||
Net deferred tax asset (liabilities)
|
$ | (3,385,545 | ) | $ | - | |||
For the Three Months Ended
|
||||||||
March 31, 2016
|
March 31, 2015
|
|||||||
Effective Tax Rate Reconciliation
|
||||||||
Income tax provision at statutory rate
|
35.0 | % | 35.0 | % | ||||
State income taxes, net of federal benefit
|
(0.1 | )% | 0.0 | % | ||||
Benefit from other comprehensive income | 21.2 | % | 0.0 | % | ||||
Foreign rate differential
|
(19.8 | )% | (12.7 | )% | ||||
Other Permanent diference
|
(2.7 | )% | (0.1 | )% | ||||
Change in Valuation Allowance
|
(12.5 | )% | (22.2 | )% | ||||
Total tax expense
|
21.1 | % | 0.0 | % |
For the Three Months Ended
|
||||||||||||
March 31, 2015
|
||||||||||||
before reclassification
|
reclassification
|
after reclassification
|
||||||||||
Operating expenses:
|
||||||||||||
Cost of sales
|
$ | 458,984 | $ | 35,078 | $ | 494,062 | ||||||
General and administrative
|
3,483,866 | (803,629 | ) | 2,680,237 | ||||||||
Selling and marketing
|
101,407 | 47,615 | 149,022 | |||||||||
Research and development
|
734,484 | 720,936 | 1,455,420 | |||||||||
Total
|
$ | 4,778,741 | $ | - | $ | 4,778,741 |
● |
overall economic and business conditions;
|
●
|
the demand for our products and services;
|
● |
competitive factors in the industries in which we compete;
|
●
|
the results of our pending and future litigation;
|
●
|
the emergence of new technologies which compete with our product and service offerings;
|
● |
our cash position and cash burn rate;
|
● |
other capital market conditions, including availability of funding sources;
|
● |
the strength of our intellectual property portfolio; and
|
●
|
changes in government regulations in China and the U.S. related to our industries.
|
I.
|
The patient selection criteria of this study is highly selective. The participants enrolled in the studies were advanced, relapsed, and refractory to other standard-of-care therapies. This selection criterion is highly distinguishable from other studies, which avoided higher risk patients. Most of these high severity patients would not have been eligible for other entities’ studies because of extramedullary involvement or because the presence of bulky tumors were deemed too risky for their trials.
|
II.
|
The treatment program design of this study is very stringent.
|
a.
|
Our higher risk patients did not receive conditioning chemotherapy, which is known as a beneficial facilitator of adoptive T cell therapies.
|
b.
|
Moreover, our higher risk patients did not receive subsequent Hematopoietic Stem Cell transplantation (HSCT), which is also known as a beneficial facilitator of adoptive T cell therapies.
|
●
|
First known report of positive safety and signal of clinical activity of EGFR CAR-T in multiple solid tumor indications,
|
●
|
Most NSCLC patients treated with CBM-EGFR.1 failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment,
|
●
|
Overall disease control rate (DCR) is 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17),
|
●
|
Objective response rate (ORR) of 25% in combined indications: 2 complete response (CR) and 1 partial response (PR) in cholangiocarcinoma, 2 PR in NSCLC and 1 PR in pancreatic cancer.
|
●
|
Offering Prospectus. A base prospectus which covers the offering, issuance and sale by us of up to $150,000,000 of our common stock, preferred stock, debt securities, warrants, rights and/or units;
|
●
|
Resale Prospectus. A prospectus to be used for the resale by the selling stockholders of up to 3,824,395 shares of the Common Stock; and
|
●
|
Sales Agreement Prospectus. A sales agreement prospectus covering the offering, issuance and sale by the registrant of up to a maximum aggregate offering price of $50,000,000 of the Common Stock that may be issued and sold under a sales agreement with Cantor Fitzgerald & Co.
|
● |
Confirm the safety and tolerability profile of CBM-EGFR.1 in cholangiocarcinoma and NSCLC;
|
● |
Explore the CBM-EGFR.1 opportunities in other solid tumor indications;
|
● |
Seek early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early CBM-EGFR.1 observation;
|
● |
Confirm the safety and tolerability profile of CBM-CD20.1 targeting CD20 for NHL;
|
● |
Explore the CBM-CD20.1 opportunities in other cancer indications;
|
● |
Seek early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early CBM-CD20.1 observation;
|
● |
Evaluate potential partners to develop an immunohistochemistry based diagnostic assay to aid in the patient selection whenever needed;
|
● |
Launch Phase II trials to explore the efficacy and safety of CD19 or CD20 CAR-T mono or combination therapies in chemo refractory/relapsing patients with hematological malignancies;
|
● |
File new CAR-T and other patents;
|
● |
Obtain approval for pending patents;
|
● |
Evaluate the feasibility of sponsoring a multi-sites Phase I/II clinical study to support the New Drug Application (NDA) for the U.S. CD40LGVAX trial;
|
● |
Evaluate feasibility of sponsoring a registration trial-like clinical study to support the New Drug Application (NDA) for an allogeneic haMPC Knee Osteoarthritis therapy (“Allo KOA”) study in the United States;
|
● |
Complete preclinical GLP safety evaluation studies of haMPC for Asthma and Chronic Obstructive Pulmonary Disease (COPD);
|
● |
Provide update on Cartilage Damage clinical study;
|
● |
Develop preclinical package for allogeneic haMPC therapy for COPD/Asthma clinical trial;
|
● |
Continue to seek advanced technologies to bolster our CAR-T China market position;
|
● |
Bolster R&D resources to fortify our intellectual properties portfolio and scientific development;
|
● |
File registration statement on Form S-8 for our 2014 Stock Option Plan;
|
● |
Upon declaration of the S-3 Registration Statement’s effectiveness, improve liquidity and fortify our balance sheet by courting institutional investors;
|
● |
Evaluate new regenerative medicine technology platform for other indications; and
|
● |
Explore new CAR-T international collaboration and /or partnership.
|
●
|
Obtain adipose (fat) tissue from the patient using our CFDA approved medical device, the A-StromalTM Kit;
|
●
|
Expand haMPCs using our proprietary culture medium (serum-free and antibiotics-free); and
|
●
|
Formulated for ReJoinTM therapy using our proprietary formulation.
|
●
|
Banking processes that ensure cell preservation and viability;
|
●
|
DNA identification for stem cell ownership; and
|
●
|
Bio-safety testing at independently certified laboratories.
|
●
|
Cell Therapy. Cell therapy involves the use of cells, whether derived from adults, third party donors or patients, from various parts of the body, for the treatment of diseases or injuries. Therapeutic applications may include cancer vaccines, cell based immune-therapy, arthritis, heart disease, diabetes, Parkinson’s and Alzheimer’s diseases, vision impairments, orthopedic diseases and brain or spinal cord injuries. This subfield also includes the development of growth factors and serums and natural reagents that promote and guide cell development.
|
●
|
Tissue Engineering. This subfield involves using a combination of cells with biomaterials (also called “scaffolds”) to generate partially or fully functional tissues and organs, or using a mixture of technology in a bioprinting process. Some natural materials, like collagen, can be used as biomaterial, but advances in materials science have resulted in a variety of synthetic polymers with attributes that would make them uniquely attractive for certain applications. Therapeutic applications may include heart patch, bone re-growth, wound repair, replacement neo-urinary conduits, saphenous arterial grafts, inter-vertebral disc and spinal cord repair.
|
●
|
Diagnostics and Lab Services. This subfield involves the production and derivation of cell lines that may be used for the development of drugs and treatments for diseases or genetic defects. This sector also includes companies developing devices that are designed and optimized for regenerative medicine techniques, such as specialized catheters for the delivery of cells, tools for the extraction of stem cells and cell-based diagnostic tools.
|
Three Months Ended March 31, 2016
|
Three Months Ended March 31, 2015
|
|||||||
CBMG
|
CBMG
|
|||||||
As stated
|
As stated
|
|||||||
Net sales and revenue
|
$ | 488,491 | $ | 603,390 | ||||
Operating expenses:
|
||||||||
Cost of sales
|
503,193 | 494,062 | ||||||
General and administrative
|
2,775,925 | 2,680,237 | ||||||
Selling and marketing
|
178,754 | 149,022 | ||||||
Research and development
|
2,398,362 | 1,455,420 | ||||||
Impairment of investments
|
- | 123,428 | ||||||
Total operating expenses
|
5,856,234 | 4,902,169 | ||||||
Operating loss
|
(5,367,743 | ) | (4,298,779 | ) | ||||
Other income (expense)
|
||||||||
Interest income
|
17,050 | 15,111 | ||||||
Other income (expense)
|
16,320 | (2,703 | ) | |||||
Total other income
|
33,370 | 12,408 | ||||||
Loss before taxes
|
(5,334,373 | ) | (4,286,371 | ) | ||||
Income taxes credit (provision)
|
1,124,260 | (800 | ) | |||||
Net loss
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | ||
Other comprehensive income (loss):
|
||||||||
Cumulative translation adjustment
|
16,073 | 19,609 | ||||||
Unrealized gain (loss) on investments, net of tax of $4,514,060 and $nil, for the three months ended March 31, 2016 and 2015, respectively
|
16,416,517 | (2,568,271 | ) | |||||
Total other comprehensive income (loss):
|
16,432,590 | (2,548,662 | ) | |||||
Comprehensive gain (loss)
|
$ | 12,222,477 | $ | (6,835,833 | ) | |||
Net loss per share:
|
||||||||
Basic
|
$ | (0.35 | ) | $ | (0.39 | ) | ||
Diluted
|
$ | (0.35 | ) | $ | (0.39 | ) | ||
Weighted average common shares outstanding:
|
||||||||
Basic
|
11,884,066 | 11,039,208 | ||||||
Diluted
|
11,884,066 | 11,039,208 |
Three Months Ended March 31, 2016
|
Three Months Ended March 31, 2015
|
|||||||
CBMG
|
CBMG
|
|||||||
As stated
|
As stated
|
|||||||
Cost of sales
|
37,039 | 35,078 | ||||||
General and administrative
|
449,781 | 915,829 | ||||||
Selling and marketing
|
47,761 | 47,615 | ||||||
Research and development
|
731,482 | 720,936 | ||||||
1,266,063 | 1,719,458 |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 488,491 | $ | 603,390 | $ | (114,899 | ) | (19 | )% |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 503,193 | $ | 494,062 | $ | 9,131 | 2 | % |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 2,775,925 | $ | 2,680,237 | $ | 95,688 | 4 | % |
●
|
An increase in legal, audit and other professional fee of $365,000;
|
●
|
An increase in director fee of $52,000;
|
●
|
An increase in insurance fee of $43,000, which mainly resulted from the increase in premium of director and officer liability and Company reimbursement insurance;
|
●
|
An increase in rental expenses of $48,000;
|
●
|
An increase in miscellaneous taxes of $39,000; and
|
●
|
A decrease in stock-based compensation expense of $466,000, which primarily resulted from forfeiture of the options due to Wei Cao who resigned as the CEO of the Company in February 2016. For further details please refer to Item 1 Note 13-Commitments and Contingencies - Service Agreement with Wei (William) Cao.
|
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 178,754 | $ | 149,022 | $ | 29,732 | 20 | % |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 2,398,362 | $ | 1,455,420 | $ | 942,942 | 65 | % |
●
|
An increase in payroll expenses of $372,000 in line with the increase of our immunotherapy research and development team. Total headcount of our R&D team increased from 34 as of March 31, 2015 to 48 as of March 31, 2016;
|
●
|
An increase in clinical trial expenditure of $311,000; and
|
●
|
An increase in depreciation and amortization of $141,000, which was mainly attributed to the technology obtained from 301 Hospital in June 2015 and newly purchased equipment for immunotherapy research and development.
|
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | - | $ | 123,428 | $ | (123,428 | ) | (100 | )% |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | (5,367,743 | ) | $ | (4,298,779 | ) | $ | (1,068,964 | ) | 25 | % | |||||
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 33,370 | $ | 12,408 | $ | 20,962 | 169 | % |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 1,124,260 | $ | (800 | ) | $ | (3,455 | ) | N/A |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | $ | (1,051,457 | ) | 25 | % |
2016
|
2015
|
Change
|
Percent
|
|||||||||||||
For the three months ended March 31,
|
$ | 12,222,477 | $ | (6,835,833 | ) | $ | 22,443,855 | (328 | )% |
For the three months ended March 31,
|
2016
|
2015
|
Change
|
|||||||||
Net loss
|
$ | (4,210,113 | ) | $ | (4,287,171 | ) | $ | (1,051,457 | ) | |||
Non cash transactions
|
1,937,712 | 2,287,306 | (349,594 | ) | ||||||||
Changes in operating assets, net
|
(1,310,396 | ) | (406,030 | ) | 224,149 | |||||||
Net cash used in operating activities
|
$ | (3,582,797 | ) | $ | (2,405,895 | ) | $ | (1,176,902 | ) |
Exposure to foreign currencies (Expressed in USD)
|
||||||||
As of March 31, 2016
|
||||||||
RMB
|
USD
|
|||||||
Cash and cash equivalents
|
3,935,457 | 334,714 | ||||||
Other current liabilities
|
(2,987,061 | ) | - | |||||
Net exposure arising from recognised assets and liabilities
|
948,396 | 334,714 |
As of March 31, 2016
|
||||||||
increase/(decrease) in foreign exchange rates
|
Effect on net loss (Expressed in USD)
|
|||||||
RMB (against USD)
|
5 | % | 30,684 | |||||
-5 | % | (30,684 | ) |
Exhibit Number
|
Description
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Executive Officer.
|
||
31.2
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Financial Officer.
|
|
Certifications Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
99.1 | Consulting agreement with Wen Tao (Steve) Liu, dated February 7, 2016* | |
99..2 | Clinical Trial Agreement, dated February 16, 2016, by and between CBMG Shanghai and Shanghai Tongji Hospital* | |
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase
|
CELLULAR BIOMEDICINE GROUP, INC.
|
|||
(Registrant)
|
|||
Date: May 9, 2016
|
By:
|
/s/ Bizuo (Tony) Liu
|
|
Bizuo (Tony) Liu
|
|||
Chief Executive Officer, Chief Financial Officer and Secretary
|
|||
(Principal Executive Officer and Principal Financial and Accounting Officer)
|
|||
1.
|
I have reviewed this quarterly report on Form 10-Q of Cellular Biomedicine Group, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15-d-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 registrant’s 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(s) 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 functions):
|
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: May 9, 2016
|
By:
|
/s/ Bizuo (Tony) Liu
|
|
Bizuo (Tony) Liu
|
|||
Chief Executive Officer, Chief Financial Officer and Secretary
|
|||
(Principal Executive Officer and Principal Financial and Accounting Officer)
|
Date: May 9, 2016
|
By:
|
/s/ Bizuo (Tony) Liu
|
|
Bizuo (Tony) Liu
|
|||
Chief Executive Officer, Chief Financial Officer and Secretary
|
|||
(Principal Executive Officer and Principal Financial and Accounting Officer)
|
|||
CONSULTANT | CELLULAR BIOMEDI CIN E GROUP, I NC. | ||||
By: |
/s/
Wen Tao (Steve) Liu
|
By: |
/s/ Bizuo (Tony) Liu
|
||
Wen Tao (Steve) Liu
|
Bizuo (Tony) Liu
|
||||
|
Chief Executive Officer
|
1.
|
As directed by the Chief Executive Officer of the Company (the ''
Executive
"), advise the Company on strategic opportunities.
|
2.
|
As directed by the Executive, advise the Company regarding China hospital resource management.
|
3.
|
As directed by the Executive, maintain the Company’s Cupertino offices.
|
4.
|
Provide other related services and advice to the Company as reasonably requested by the Company from time to time.
|
1.
|
All options will expire on May 6, 2017 or 3 months after Steve Liu’s board role ends, whichever is later
|
2.
|
Options granted in 20 13 at a $3.00 strike price will continue to vest a t a monthly rate until fully vested.
|
3.
|
Options granted in 2015 at a strike price of $15.53 will continue to vest at a monthly rate until February 6, 2017. An estimated 11,222 options will vest in this period.
|
Party A:
|
CBMG Shanghai
|
Legal Address:
|
5
th
and 6
th
Floors, No.1 Building, Juke Biotech Park, 333 Guiping Road, Shanghai
|
Party B:
|
Shanghai Tongji Hospital
|
Legal Address:
|
389 Xincun Road, Putuo District, Shanghai
|
|
1.
|
As the sponsor, Party A hopes that Party B will do the clinical test (hereinafter referred to as “Clinical Test” and “Test”) for Party A by using the agreed investigator
Professor Liang Aibin
under the clinical research plan <safety clinical test of using CBMG-CAR T-19 to treat patients with recurrent and refractory CD19
+
B-acute lymphoblastic leukemia (abbreviated as “B-ALL”)>;
|
|
2.
|
Party B and investigator
Professor Liang Aibin
agree to do the aforesaid test for Party A;
|
Article 1
|
Title of research plan: Safety clinical test of using CBMG-CAR T-19 to treat patients with recurrent and refractory CD19
+
B-ALL
|
Article 2
|
Number of plan: CBMG2016001
|
Article 3
|
Date of finalizing plan: January 28, 2016
|
Article 1
|
Name of clinical test item: CBMG-CAR T-19
|
Article 1
|
Clinical test center: Shanghai Tongji Hospital
|
Article 2
|
Clinical test principal (investigator): Professor Liang Aibin
|
Article 3
|
Clinical test case: 12 cases
|
|
Qualified cases of finishing the treatment course and receiving the follow-up visit: 12 cases
|
Article 4
|
Schedule requirements:
|
|
1.
|
The date of the aforesaid center’s getting the Ethics Committee’s research approval: January 27, 2016
|
|
2.
|
The date of screening and evaluating the first case: February 18, 2016
|
|
3.
|
The date of selecting the first qualified case: March 18, 2016
|
|
4.
|
The date of selecting the last qualified case: June 15, 2016
|
|
5.
|
The date of the last qualified case’s finishing the treatment and receiving the follow-up visit: September 30, 2016
|
|
6.
|
The date of final project summary: November 30, 2016
|
Article 1
|
Party A:
|
|
1.
|
Shall be responsible for sponsoring, applying for, organizing, subsidizing and supervising the test.
|
|
2.
|
Shall jointly formulate the test plan with Party B.
|
|
3.
|
Shall be responsible for implementing the aforesaid plan and organizing the test in accordance with the laws and regulations related to clinical test of the People’s Republic of China (abbreviated as the “PRC”) and the Declaration of Helsinki and after getting the consent of the test unit’s Ethics Committee or the group leader unit’s Ethics Committee.
|
|
4.
|
Shall provide the investigator’s brochure and its reprinted number.
|
|
5.
|
Shall provide the test items conforming to relevant stipulations of national laws, regulations and others.
|
|
6.
|
Shall regularly supervise, check and inspect the test in accordance with the
Good Clinical Practice
(abbreviated as “GCP”) and other relevant laws and regulations. The aforesaid supervision, check and examination can be conducted by the supervisor, checker and inspector appointed by Party A and agreed by Party B or officers of China Food and Drug Administration (abbreviated as “CFDA”).
|
|
7.
|
Shall provide Party B with the test expenditures pursuant to the Article 9 hereof.
|
|
8.
|
Shall be responsible for build a quality control and quality assurance system for the test. When it is necessary, Party A can organize the monitoring and check for the test to assure its quality.
|
|
9.
|
Shall jointly and rapidly investigate any serious adverse event with Party B, adopt any necessary measure to ensure the subject’s safety, timely report the aforesaid event to relevant food and drug administration department, and meanwhile report it to other investigators using the same item to do the test.
|
|
10.
|
Shall submit a summary report of the aforesaid test to the CFDA or any other relevant government department, or give a report of terminating the test and reasons. Where the test is terminated by Party A and isn’t initiated by Party B, Party B shall return Party A 95% of down payment; where any dispute or lawsuit generating in the test is caused by Party A’s early termination, Party B shall instantly inform Party A in written form, and fully cooperate with Party A for disposing the aforesaid dispute or lawsuit. Party A shall bear any expense generating in the disposal.
|
|
11.
|
Where Party B does the test violating the approved plan, the GCP, or relevant laws and regulations, Party A shall point out the aforesaid behavior and ask Party B to correct it. Where the condition is serious and remains the same continuously, Party A shall terminate Party B’s participation in the test and report the aforesaid condition to the CFDA or any other relevant government department.
|
|
12.
|
Party A has provided corresponding insurance pursuant to the GCP, and shall bear any medical expense and corresponding economic compensation for any damage or death generating in the test and having causality with the aforesaid test of patients conforming to the selection standard.
|
|
13.
|
Party A shall not bear any compensation for any damage to the patient caused by the natural development of disease, taking any other non-research drug, or violating the test plan in the research.
|
|
14.
|
Shall obey the GCP of the PRC and any other relevant law and regulation.
|
|
15.
|
After the test, Party A shall draft a summary report, be responsible for the publication of subsequent research paper, and send a copy of the aforesaid paper to Party B after signature and dating.
|
Article 2
|
Party B and/or test principal:
|
|
1.
|
Shall acquire and maintain the qualification of doing clinical test, and have professional knowledge, experience and others required by the test plan.
|
|
2.
|
Shall choose cases; organize implementation and record details pursuant to the test plan hereunder.
|
|
3.
|
Shall obey the stipulations of the GCP, relevant laws and regulations and the Clinical Test Plan, and cooperate with the supervisor, checker and inspector to assure the test quality.
|
|
4.
|
Shall warrant the sufficient time, qualified place and disposable personnel boasting clinical test qualification to be responsible for and finish the test within the term stipulated by the aforesaid plan.
|
|
5.
|
Shall disclose details related to the test to subjects after getting the consent of Ethics Committee, and get the Informed Consent Form signed by the patient or the aforesaid patient’s client.
|
|
6.
|
Shall be responsible for making any medical decision related to the test, and warrant that subjects can get proper treatment in case of any adverse event incurred in the aforesaid test.
|
|
7.
|
Shall adopt any necessary measure to warrant subjects’ safety and record accordingly. In case of any serious adverse event in the aforesaid test, Party B shall instantly adopt any proper treatment measure for the subject, report the aforesaid event to relevant drug administration department, Party A and the Ethics Committee, and sign its name and write the date on the aforesaid report.
|
|
8.
|
Shall inform subjects, Party A, the Ethics Committee, the CFDA and relevant government department of the test’s early termination and suspension, and expound relevant reasons.
|
|
9.
|
Pursuant to the requirement of Appendix 2 of the GCP, Party B shall be responsible for saving corresponding test data for five (5) years after the test. Party A shall initiatively contact Party B to discuss follow-up issues of data saving within three (3) months prior to the deadline. In case that Party A doesn’t initiatively contact Party B within one (1) month after the deadline, Party B shall be entitled to dispose the aforesaid date by itself.
|
|
10.
|
Confidentiality clauses:
|
|
● |
During the validity hereof and within ten (10) years after the termination hereof, Party B (including the test principal and all personnel participating in the test) shall adopt any positive measure to strictly keep the confidential information. Except the conditions specified herein, Party B shall not disclose any aforesaid information to any third Party or use the aforesaid information for any other purpose.
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● |
Confidential information refers to the information received by Party B (including the test principal and all personnel participating in the test) from Party A during the validity hereof, or incurred, created or acquired related to the test in the process of performing the Agreement, including but not limited to the clinical test plan, research specimen, test data, research result and report.
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●
|
The purpose of providing relevant information during the test lies in helping Party A do a clinical test. The investigator, based on the same purpose and conforming to conditions hereunder, can disclose any content of the test plan and other materials to any personnel participating in the test or any juror of investigator agency, the Ethics Committee, and the Pharmacy Administration Committee. Any content hereof shall not be used in any other clinical test. Party B shall not arbitrarily disclose any content of the test and technology to any other person or collective without Party A’s prior written consent. In addition, any supplemental information and technology update of the test shall be confidential and owned by Party A, and the confidential principle shall be deemed as the content like original plan/technology materials. The confidentiality of information or technology shall only be used in the matters authorized by Party A and not be disclosed to any other person without Party A’s prior written consent.
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●
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Any information and technology contained in the test shall be confidential and owned by Party A. Party B agrees Party A’s definition of confidential information. Any deliberate or negligent disclosure of Party A’s intellectual property in any form shall be deemed as breach hereof, and Party A shall be entitled to adopt any measure to protect commercial secrets, and to claim any compensation based on the circumstance and damage degree.
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Article 1
|
Party B and the investigator of its research unit hereby admit and agree that Party A shall be entitled to disclose or make the test plan, research methods and research results hereof public on any seminar, national or regional academic conference, professional journal, paper, record that all the people around the world can get, or in any other way decided by itself, including but not limited to the case that Party B and the investigator of its research unit agree Party A to disclose the aforesaid results in the way of abstract or other ways on the “clinical test record” of Party A’s website before (or after) the aforesaid disclosure and publication in accordance with relevant stipulations of publishing and disclosing Party A’s test results in the standard operating procedure. Where Party A coordinates to do multicenter publication, relevant conditions of the main investigator of the aforesaid research unit participating in the aforesaid publication as the by-liner shall be decided pursuant to Party A’s policy and generally recognized signature standards. In addition, the aforesaid unit and its investigator agree Party A to disclose the aforesaid investigator’s name, any detail of the unit and/or any detail of other research institution related to the aforesaid investigator on a or several records that all the people around the world can get at any time.
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Article 2
|
Signature on results: Both Parties can jointly declare the scientific achievements of the research results; and Party B can separately declare the aforesaid research results after getting Party A’s written consent.
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Article 3
|
Thesis: When the thesis is jointly published by both Parties, Party B shall be the first author (ranking ahead) and corresponding author (the last), and Party A shall be the parallel first author (ranking second) and parallel corresponding author (second to last).
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Article 4
|
Where Party B publishes, introduces, extracts, compiles, posts or discloses the aforesaid results in any other way for the teaching aim, Party B shall give Party A at least sixty (60) days for review and discuss with Party A about the contents to be disclosed. Party A shall be entitled to properly delete or modify any confidential information contained in the aforesaid publication and introduction materials. Party B shall not disclose or publish any aforesaid result without Party A’s written consent.
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Article 1
|
Any confidential information hereof and any intellectual property (including but not limited to copyright, invention, discovery, patent, technical know-how and others) incurred in the test shall be Party A’s property.
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Article 2
|
Party A shall freely provide relevant resources for the test, and the research results achieved through cooperation, published papers and others shall indicate the sources.
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Article 3
|
Both Parties shall share the research results hereof, including but not limited to: any article published at home and abroad related to the test shall have signatures and unit names of both Parties.
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Article 4
|
When publishing any information related to the other Party, one Party shall get the other Party’s consent before such publication; both Parties shall keep the project’s technical and commercial secrets and shall not violate the Agreement to disclose and transfer any technical result to any other third Party.
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Article 1
|
Party A shall provide necessary equipment of clinical test, including
laboratory consumables, cell transport cases, refrigerators, water baths
and others.
|
|
1.
|
Party A shall be entitled to decide whether such necessary equipment is necessary for the test and whether to provide the aforesaid equipment by itself;
|
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2.
|
The aforesaid necessary equipment shall only be used in the clinical test pursuant to the ways in Party A’s written indication;
|
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3.
|
The aforesaid necessary equipment shall be placed at a safe place and its data shall only be recorded by research personnel appointed by the investigator;
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4.
|
Any information related to a subject visited shall be filed in a prescribed way after the interview or within three (3) days after receiving the aforesaid subject’s test data (if applicable);
|
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5.
|
Any data query of Party A shall be finished and returned to Party B within seven (7) days (final data arrangement term is one day) or other time stipulated by Party A;
|
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6.
|
Party B shall adopt any proper measure and way to prevent any computer equipment and/or software system from being stolen, damaged and lost;
|
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7.
|
Party A shall ensure network access necessary for use of the aforesaid software system, and pay any expense generated therefrom;
|
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8.
|
After the test, Party B shall return any training material and document related to the aforesaid necessary equipment to Party B and research personnel doing the test.
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Article 2
|
About the aforesaid equipment
|
|
1
|
The ownership of the aforesaid equipment shall be possessed by Party A and the aforesaid equipment can only be used in the clinical test. Party B shall immediately return the equipment to Party A in perfect condition at the end of test or pursuant to the requirement of Party A.
|
Article 1
|
On the premise of obeying all applicable laws and regulations and getting Party A’s prior notice, Party B shall ensure that Party A’s inspectors can visit the research record at any proper time for inspecting and verifying the data sources.
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Article 2
|
Pursuant to Party A’s proper requirements and after Party A informs Party B seven (7) days in advance in written form, Party B shall allow Party A’s auditors to conduct retrieval and inspection of research record, relevant data and research equipment once a year.
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Article 3
|
Pursuant to the stipulations of the GCP and Party A’s policy, any subject’s identification code, archive, clinical test data and relevant files provided by Party A for the clinical test shall be properly kept by Party B for five (5) years after the aforesaid test. After the expiration, both Parties shall confirm the keeping way through consultation.
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Article 1
|
Expenditures of clinical test
|
|
1.
|
The fee for main investigators: RMB
40,000
.
|
|
2.
|
The observation fee of clinical test is RMB
15,000
for each qualified case. Party A shall totally pay Party B RMB
180,000
for estimated
12
cases, seeing Appendix 1.
|
|
3.
|
Fees related to patient (such as inspection and examination fee, medical fee and others) shall be paid pursuant to the actual fees incurred in conducting the interview and visit according to the plan. The fees shall be estimated to RMB
500,000
.
|
|
4.
|
The aforesaid necessary equipment provided by Party A shall be taken back after the test.
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Article 2
|
Expenditures shall be paid in installments by stage and performance:
|
|
1.
|
The fee for main research shall be paid by three (3) installments. After Party B finishes
six (6)
target cases, Party A shall pay RMB
10,000.
After Party B finishes
twelve (12)
target cases, Party A shall pay RMB
10,000.
After Party B finishes the clinical research report and signs and seals on it, Party A shall pay Party B the remaining RMB
20,000
.
|
|
2.
|
The observation fee of clinical test shall be paid by three (3) installments. After Party B finishes
six (6)
target cases, Party A shall pay RMB
60,000.
After Party B finishes
twelve (12)
target cases, Party A shall pay RMB
60,000.
After Party B finishes the clinical research report and signs and seals on it, Party A shall pay Party B the remaining RMB
60,000
.
|
|
3.
|
Fees related to patient (such as inspection and examination fee, medical fee and others) shall be paid by three (3) installments. Before Party B starts doing the clinical test, Party A shall pay the testing fee of RMB
200,000.
After Party B finishes the inspection of twelve (12) selected target cases required, Party A shall pay the testing fee of RMB
200,000.
After Party B finishes the observation of twelve (12) selected target cases required by the test, Party A shall pay Party B the testing fee of RMB
100,000
.
|
|
4.
|
After Party B finishes test of all the twelve (12) selected target cases required by the plan, Party A shall pay Party B all the remaining test expenditures actual incurred after receiving all test data and the final test report.
|
Article 3
|
Approval fee of Ethics Committee
|
Article 4
|
Payment
|
Article 1
|
Party B and its investigator admit to receive the “Prevention of Corruption-the Third Party’s Guide” and agree to perform their obligations hereunder pursuant to the principles set forth in the aforesaid guide.
|
Article 2
|
Party B and its investigator shall fully obey all applicable laws and regulations all the time, including but not limited to the applicable anti-corruption law of the place where Party B and Party A have business contact.
|
Article 3
|
Party B and its investigator agree and undertake they will not directly or indirectly disclose the performance situation to (1) any personage including government officials (as hereinafter defined); or (2) the intermediary of paying money for any personage including government officials; or (3) any political party which promises, authorizes, approves, provides or facilitates any payment or transfers any valuable article. Either party shall not make any promise, authorization and approval, or urge any payment or value transfer, only to disclose, to accept commercial bribe, to accept or connive blackmail and rebate, to seek unjust benefits, or to acquire or maintain business in any other illegal or improper means.
|
Article 4
|
For the purpose herein, the “government official” refers to (1) any official or personnel of government, any government department, agency or institution; (2) any individual acting on behalf of an official of the aforesaid government, government department, agency or institution; (3) any official or personnel of the company or business wholly or partially owned by the government; (4) any official or personnel of any public international organization such as the World Bank, the United Nations and others; (5) any official or personnel of any political party, or any personage acting as an official of any political party; and/or (6) any candidate of any political entity.
|
Article 5
|
Party B and its investigator shall not contact or meet with any government official for any transaction hereunder without Party A’s prior written approval, and shall only contact or meet with the aforesaid official witnessed by the representative appointed by Party A after getting Party A’s approval.
|
Article 6
|
Party B and its investigator represent that they were not convicted of any crimes before or suspected of any criminal offence, including fraud, corruption or moral violation. As far as they know, they are not investigated by any government, are not forbidden and suspended, will not be suspended or forbidden by any government institution, or are not deprived of qualification of applying for any government project in other ways.
|
Article 7
|
Party B and its investigator represent and undertake that, except the disclosure in written form, (1) they don’t have any benefit that will directly or indirectly conflict with their proper and moral performance hereof; and (2) they shall maintain the fair relation with all third Parties (including government officials) for and on behalf of Party A (in the process of performing the Agreement).
|
Article 8
|
Party A shall be entitled to investigate and audit Party B and its investigator during the term hereof for supervising the abidance of Party B and its investigator to the clause. Party B and its investigator shall fully coordinate the aforesaid investigation or auditing, and the range, way, property and duration of such investigation or auditing shall be fully and properly decided by Party A.
|
Article 9
|
Party B shall ensure that all transactions hereunder are properly and correctly recorded in the account and record in all substantive aspects, and each document as the basis of accounting and recording is complete and accurate in all substantive aspects. Party B shall maintain the internal accounting control system through rational design for ensuring that there is no any concealed account.
|
Article 10
|
Party B and its investigator agree that Party A can fully disclose any information related to possible violation of the clauses hereunder to any government agency, its resident agency and any person Party A thinks necessary to inform legally, at any time and due to any cause.
|
Article 11
|
Where Party B or its investigator fails to perform obligations pursuant to the Chapter, Party A shall be entitled to inform Party B to immediately terminate the Agreement in written form, and Party B and its investigator shall not claim any compensation from Party A. Where Party A has to pay Party B and its investigator any aforesaid compensation due to the termination of the Agreement pursuant to relevant local laws (only within the scope allowed by the aforesaid law), Party B and its investigator hereby explicitly agree to waive (within the scope allowed by the aforesaid law) or repay any aforesaid compensation to Party A.
|
Article 1
|
Both Parties agree that either Party shall not use the other Party's name for any purpose without the other Party's prior written approval, but the other Party shall not refuse to give the aforesaid approval without any reason.
|
Article 1
|
Where any clause hereof is deemed as invalid, illegal or unenforceable due to any reason, the aforesaid clause shall be deemed as being deleted from the Agreement, and other clauses hereof shall continue to be fully effective.
|
Article 1
|
The Agreement shall be explained and governed by relevant laws of the PRC.
|
Article 2
|
In case of any dispute incurred herein or related to the Agreement, all Parties shall settle the aforesaid dispute through friendly negotiation. Where either Party is unwilling to settle the aforesaid dispute through negotiation or the dispute cannot be settled within thirty (30) days when the negotiation begins, the aforesaid dispute shall be submitted to the Shanghai Branch of China International Economic and Trade Arbitration Commission (abbreviated as the “CIETAC”) for being settled through the arbitration in accordance with the effective arbitration rules.
|
Article 3
|
The arbitral award shall be final and have binding to both Parties. Unless otherwise stipulated herein, the arbitration fee shall be borne by the unsuccessful Party.
|
Article 4
|
In the process of friendly negotiation and arbitration, except any disputable part and any part under arbitration, other parts hereof shall be performed continuously.
|
Article 1
|
In case that either Party fails to perform the Agreement due to any force majeure such as war, serious fire hazard, flood, typhoon, earthquake or any other event agreed by both Parties, the aforesaid Party shall not assume any liability. The term of performing the Agreement shall be extended for a period as long as the duration of such force majeure.
|
Article 2
|
The influenced Party shall inform the other Party by fax or telex within the shortest time after the force majeure event and send the other Party a certificate issued by relevant authority through the registered mail by air within fourteen (14) days for the other Party to affirm the aforesaid force majeure.
|
Article 2
|
Any modification hereof and of the appendixes shall come into force upon signing and sealing of authorized representatives of both Parties.
|
Article 1
|
The Agreement and appendixes constitute the entire Agreement concluded by both Parties on the clinical test, and the aforesaid entire Agreement shall replace any Agreement, understanding or arrangement reached by both Parties before.
|
Article 1
|
The Agreement shall come into force as from the date when authorized representatives of both Parties sign and seal, and shall keep valid until the completion of the clinical test and the performance of all the rights and obligations hereunder by both Parties.
|
Article 2
|
Before terminating a clinical test ahead of schedule, Party A shall inform the investigator, the Ethics Committee and the CFDA in advance and explain reasons. When the test terminates, Party A shall pay the clinical test expenditures pursuant to actual expenses and all work done or finished by the investigator before the termination date.
|
Article 3
|
The investigator Professor Liang Aibin (doctor) signs on the Agreement for affirming that he is bound by the Agreement and enjoys and undertakes corresponding rights and obligations of investigator.
|
Party A: CBMG Shanghai
Authorized Representative (Signature):
Signature of Project Leader:
Unit (Official Seal):
Date: 2016-2-16
|
Party B: Shanghai Tongji Hospital
Authorized Representative (Signature):
Signature of Project Leader:
Unit (Official Seal):
Date:
|
Screening period
|
Baseline period
|
Treatment period
|
Follow-up visit period
|
|||||||||
-4w
|
-1w
|
Day 0
|
Day 1
|
Day 2
|
Day 4
|
Day 7
|
Day 10
|
2w
|
3w
|
4w
|
8w
|
12w
|
1.
|
The results of imageological diagnosis, bone marrow and lumbar puncture within four (4) weeks in the baseline period can also be used for the baseline period evaluation;
|
2.
|
Detecting only the levels of serum potassium and uric acid;
|
3.
|
Detecting the cytokine and CRP after the retransformation each time, totally for three (3) times.
|