|
|
|
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Bermuda
|
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98-1333697
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(State or other jurisdiction of
incorporation or organization)
|
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(I.R.S. Employer
Identification No.)
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|
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Suite 1, 3rd Floor
11-12 St. James's Square
London SW1Y 4LB, United Kingdom
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Not Applicable
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(Address of principal executive offices)
|
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(Zip Code)
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Large accelerated filer
|
o
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Accelerated filer
|
x
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Non-accelerated filer
|
o
(Do not check if a smaller reporting company)
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Smaller reporting company
|
o
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Emerging growth company
|
x
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Page
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|
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June 30, 2018 |
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March 31, 2018
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||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash
|
$
|
92,934
|
|
|
$
|
154,337
|
|
Prepaid expenses and other current assets
|
7,448
|
|
|
2,174
|
|
||
Income tax receivable
|
1,616
|
|
|
1,751
|
|
||
Total current assets
|
101,998
|
|
|
158,262
|
|
||
|
|
|
|
||||
Other non-current assets
|
3,784
|
|
|
—
|
|
||
Property and equipment, net
|
1,802
|
|
|
2,524
|
|
||
|
|
|
|
||||
Total assets
|
$
|
107,584
|
|
|
$
|
160,786
|
|
|
|
|
|
||||
Liabilities and Shareholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
1,431
|
|
|
$
|
3,949
|
|
Due to RSL, RSI and RSG
|
2,156
|
|
|
1,011
|
|
||
Accrued expenses
|
25,133
|
|
|
31,862
|
|
||
Current portion of long-term debt
|
14,791
|
|
|
9,753
|
|
||
Total current liabilities
|
43,511
|
|
|
46,575
|
|
||
|
|
|
|
||||
Long-term debt
|
38,247
|
|
|
42,925
|
|
||
|
|
|
|
||||
Total liabilities
|
81,758
|
|
|
89,500
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 11)
|
|
|
|
|
|
||
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
|
|
||
Common shares, par value $0.00001 per share, 1,000,000,000 shares authorized, 107,795,074 and 107,788,074 issued and outstanding at June 30, 2018 and March 31, 2018, respectively
|
1
|
|
|
1
|
|
||
Additional paid-in capital
|
633,979
|
|
|
628,110
|
|
||
Accumulated deficit
|
(608,839
|
)
|
|
(556,951
|
)
|
||
Accumulated other comprehensive income
|
685
|
|
|
126
|
|
||
Total shareholders’ equity
|
25,826
|
|
|
71,286
|
|
||
Total liabilities and shareholders’ equity
|
$
|
107,584
|
|
|
$
|
160,786
|
|
|
Three Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Operating expenses:
|
|
|
|
||||
Research and development expenses
(1)
|
|
|
|
||||
(includes total share-based compensation expense of $2,517 and $6,256 for the three months ended June 30, 2018 and 2017, respectively)
|
$
|
37,418
|
|
|
$
|
43,712
|
|
General and administrative expenses
(2)
|
|
|
|
||||
(includes total share-based compensation expense of $3,342 and $9,344 for the three months ended June 30, 2018 and 2017, respectively)
|
11,754
|
|
|
21,518
|
|
||
Total operating expenses
|
49,172
|
|
|
65,230
|
|
||
Other expenses:
|
|
|
|
||||
Interest expense
|
1,970
|
|
|
1,874
|
|
||
Other expense (income)
|
668
|
|
|
(357
|
)
|
||
Loss before income tax expense
|
(51,810
|
)
|
|
(66,747
|
)
|
||
Income tax expense
|
78
|
|
|
2,519
|
|
||
Net loss
|
$
|
(51,888
|
)
|
|
$
|
(69,266
|
)
|
Net loss per common share — basic and diluted
|
$
|
(0.48
|
)
|
|
$
|
(0.65
|
)
|
Weighted average common shares outstanding — basic and diluted
|
107,789,920
|
|
|
106,400,912
|
|
|
Three Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
|
|
|
|
||||
Net loss
|
$
|
(51,888
|
)
|
|
$
|
(69,266
|
)
|
Other comprehensive income (loss):
|
|
|
|
||||
Foreign currency translation adjustment
|
559
|
|
|
(349
|
)
|
||
Total other comprehensive income (loss)
|
559
|
|
|
(349
|
)
|
||
Comprehensive loss
|
$
|
(51,329
|
)
|
|
$
|
(69,615
|
)
|
|
Common Shares
|
|
Additional Paid-in Capital
|
|
Accumulated
Deficit
|
|
Accumulated Other Comprehensive Income
|
|
Total
Shareholders’
Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance at March 31, 2018
|
107,788,074
|
|
|
$
|
1
|
|
|
$
|
628,110
|
|
|
$
|
(556,951
|
)
|
|
$
|
126
|
|
|
$
|
71,286
|
|
Exercise of stock options
|
7,000
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
|
10
|
|
|||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
5,369
|
|
|
—
|
|
|
—
|
|
|
5,369
|
|
|||||
Capital contribution — share-based compensation expense
|
—
|
|
|
—
|
|
|
490
|
|
|
—
|
|
|
—
|
|
|
490
|
|
|||||
Foreign currency translation adjustment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
559
|
|
|
559
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(51,888
|
)
|
|
—
|
|
|
(51,888
|
)
|
|||||
Balance at June 30, 2018
|
107,795,074
|
|
|
$
|
1
|
|
|
$
|
633,979
|
|
|
$
|
(608,839
|
)
|
|
$
|
685
|
|
|
$
|
25,826
|
|
|
Three Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
|
|||
Net loss
|
$
|
(51,888
|
)
|
|
$
|
(69,266
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|||
Foreign currency translation adjustment
|
559
|
|
|
(349
|
)
|
||
Share-based compensation
|
5,859
|
|
|
15,600
|
|
||
Depreciation and non-cash amortization
|
1,034
|
|
|
335
|
|
||
Deferred tax assets
|
—
|
|
|
2,709
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|||
Prepaid expenses and other current assets
|
(5,274
|
)
|
|
(1,170
|
)
|
||
Other non-current assets
|
(3,784
|
)
|
|
—
|
|
||
Accounts payable
|
(2,518
|
)
|
|
(4
|
)
|
||
Due to RSL, RSI and RSG
|
1,193
|
|
|
1,547
|
|
||
Accrued expenses
|
(6,729
|
)
|
|
3,245
|
|
||
Income tax receivable
|
135
|
|
|
(566
|
)
|
||
Net cash used in operating activities
|
(61,413
|
)
|
|
(47,919
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|||
Purchases of property and equipment
|
—
|
|
|
(2,171
|
)
|
||
Net cash used in investing activities
|
—
|
|
|
(2,171
|
)
|
||
Cash flows from financing activities:
|
|
|
|
|
|||
Exercise of stock options
|
10
|
|
|
747
|
|
||
Cash proceeds from issuance of common shares, net of costs
|
—
|
|
|
134,628
|
|
||
Net cash provided by financing activities
|
10
|
|
|
135,375
|
|
||
Net change in cash
|
(61,403
|
)
|
|
85,285
|
|
||
Cash—beginning of period
|
154,337
|
|
|
212,573
|
|
||
Cash—end of period
|
$
|
92,934
|
|
|
$
|
297,858
|
|
|
June 30, 2018
|
|
March 31, 2018
|
||||
|
|
|
|
||||
Research and development expenses
|
$
|
18,831
|
|
|
$
|
21,855
|
|
Salaries, bonuses, and other compensation expenses
|
2,722
|
|
|
7,718
|
|
||
Legal expenses
|
2,043
|
|
|
779
|
|
||
Other expenses
|
1,537
|
|
|
1,510
|
|
||
Total accrued expenses
|
$
|
25,133
|
|
|
$
|
31,862
|
|
Exercise price
|
|
$
|
12.04
|
|
Share price on date of issuance
|
|
$
|
11.96
|
|
Volatility
|
|
77.6
|
%
|
|
Risk-free interest rate
|
|
2.27
|
%
|
|
Expected dividend yield
|
|
—
|
%
|
|
Contractual term (in years)
|
|
7
|
|
|
|
June 30, 2018
|
|
March 31, 2018
|
||||
|
|
|
|
|
||||
Principal amount
|
|
$
|
55,000
|
|
|
$
|
55,000
|
|
Less: unamortized discount and debt issuance costs
|
|
(1,962
|
)
|
|
(2,322
|
)
|
||
Loan payable less unamortized discount and debt issuance costs
|
|
53,038
|
|
|
52,678
|
|
||
Less: current portion of long-term debt
|
|
(14,791
|
)
|
|
(9,753
|
)
|
||
Long-term loan payable, net of current maturities
|
|
$
|
38,247
|
|
|
$
|
42,925
|
|
|
Balance as of
|
|
|
|
|
|
|
|
Balance as of
|
||||||||||
|
March 31, 2018
|
|
Expenses, net
|
|
Cash
|
|
Noncash
|
|
June 30, 2018
|
||||||||||
|
|
|
|
|
(in thousands)
|
|
|
|
|
||||||||||
Employee severance and
|
|
|
|
|
|
|
|
|
|
||||||||||
other personnel benefits
|
$
|
2,460
|
|
|
$
|
—
|
|
|
$
|
(978
|
)
|
|
$
|
—
|
|
|
$
|
1,482
|
|
•
|
the success and timing of our ongoing development and commercialization of AXO-Lenti-PD, AXO-AAV-OPMD, nelotanserin and RVT-104;
|
•
|
our relationship under our license agreement with Oxford BioMedica (UK) Ltd. and Benitec Biopharma Limited;
|
•
|
the success of our interactions with international regulatory authorities;
|
•
|
the anticipated start dates, durations and completion dates of our ongoing and future nonclinical studies and clinical trials;
|
•
|
the anticipated designs of our future clinical studies;
|
•
|
anticipated future regulatory submissions and the timing of, and our ability to, obtain and maintain regulatory approval for our product candidates;
|
•
|
the rate and degree of market acceptance and clinical utility of any approved product candidate;
|
•
|
our ability to identify and in-license or acquire additional product candidates;
|
•
|
our commercialization, marketing and manufacturing capabilities and strategy;
|
•
|
continued service of our key scientific or management personnel;
|
•
|
our ability to obtain, maintain and enforce intellectual property rights for our product candidates;
|
•
|
our anticipated future cash position;
|
•
|
our estimates regarding our results of operations, financial condition, liquidity, capital requirements, prospects, growth and strategies;
|
•
|
the success of competing drugs that are or may become available;
|
•
|
our stated objective of becoming the leading biopharmaceutical company focused on neurology and psychiatry.
|
Compound
|
Clinical Indication
|
Development Stage
|
|
|
|
Gene Therapy Programs
|
|
|
AXO-Lenti-PD
|
Parkinson's disease
|
Phase 1/2
|
|
|
|
AXO-AAV-OPMD
|
Oculopharyngeal muscular dystrophy
|
Preclinical
|
|
|
|
AXO-AAV-ALS
|
Amyotrophic lateral sclerosis
|
Research
|
|
|
|
AXO-AAV-FTD
|
Frontotemporal dementia
|
Research
|
|
|
|
Four additional AXO-AAV
|
Undisclosed
|
Research
|
Collaboration Programs
|
|
|
|
|
|
Small Molecule Programs
|
|
|
Nelotanserin
|
Visual hallucinations in LBD
|
Phase 2 Pilot Study Completed
|
|
REM sleep behavior disorder in LBD
|
Phase 2 Ongoing
|
|
|
|
RVT-104
|
Alzheimer's disease and DLB
|
Proof of Concept
|
|
|
|
•
|
Part A is a non-randomized dose-escalation of multiple potential dose levels.
|
•
|
Part B is a double-blind design with patients randomized either to an active group receiving the optimal dose as determined in Part A, or a control group receiving an imitation "sham" surgical procedure.
|
•
|
direct third-party costs, which include expenses incurred under agreements with contract research organizations and contract manufacturing organizations, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, and any other third-party expenses directly attributable to the development of our product candidates; and
|
•
|
upfront payments for the purchase of in-process research and development, which include costs incurred under the Oxford BioMedica Agreement and the Arena Development Agreement.
|
•
|
share-based compensation expense for research and development personnel, including expense related to RSL common share awards and RSL options issued by RSL to RSI and RSG employees;
|
•
|
personnel-related expenses, which include employee-related expenses, such as salaries, benefits and travel expenses, for research and development personnel;
|
•
|
costs allocated to us under our services agreements with RSI and RSG; and
|
•
|
other expenses, which includes the cost of consultants who assist with our research and development but are not allocated to a specific program.
|
•
|
the number of trials required for approval;
|
•
|
the per patient trial costs;
|
•
|
the number of patients who participate in the trials;
|
•
|
the number of sites included in the trials;
|
•
|
the countries in which the trials are conducted;
|
•
|
the length of time required to enroll eligible patients;
|
•
|
the number of doses that patients receive;
|
•
|
the drop-out or discontinuation rates of patients;
|
•
|
the potential additional safety monitoring or other studies requested by regulatory agencies;
|
•
|
the duration of patient follow-up;
|
•
|
the timing and receipt of regulatory approvals; and
|
•
|
the efficacy and safety profile of the product candidates.
|
|
Three Months Ended June 30, |
|
|
||||||||
|
2018
|
|
2017
|
|
Change
|
||||||
Operating expenses:
|
|
||||||||||
Research and development expenses
|
|
|
|
|
|
||||||
(includes total share-based compensation expense of $2,517 and $6,256 for the three months ended June 30, 2018 and 2017, respectively)
|
$
|
37,418
|
|
|
$
|
43,712
|
|
|
$
|
(6,294
|
)
|
General and administrative expenses
|
|
|
|
|
|
||||||
(includes total share-based compensation expense of $3,342 and $9,344 for the three months ended June 30, 2018 and 2017, respectively)
|
11,754
|
|
|
21,518
|
|
|
(9,764
|
)
|
|||
Total operating expenses
|
$
|
49,172
|
|
|
$
|
65,230
|
|
|
$
|
(16,058
|
)
|
|
Three Months Ended June 30, |
|
|
||||||||
|
2018
|
|
2017
|
|
Change
|
||||||
Program-specific costs:
|
|
|
|
|
|
||||||
AXO-Lenti-PD
|
$
|
25,132
|
|
|
$
|
—
|
|
|
$
|
25,132
|
|
Intepirdine
|
1,297
|
|
|
26,807
|
|
|
(25,510
|
)
|
|||
Nelotanserin
|
3,354
|
|
|
3,214
|
|
|
140
|
|
|||
RVT-103
|
1
|
|
|
243
|
|
|
(242
|
)
|
|||
RVT-104
|
(76
|
)
|
|
349
|
|
|
(425
|
)
|
|||
Unallocated internal costs:
|
|
|
|
|
|
||||||
Share-based compensation
|
2,517
|
|
|
6,256
|
|
|
(3,739
|
)
|
|||
Personnel-related
|
1,536
|
|
|
3,841
|
|
|
(2,305
|
)
|
|||
Services agreements
|
2,245
|
|
|
1,092
|
|
|
1,153
|
|
|||
Other
|
1,412
|
|
|
1,910
|
|
|
(498
|
)
|
|||
Total research and development expenses
|
$
|
37,418
|
|
|
$
|
43,712
|
|
|
$
|
(6,294
|
)
|
•
|
initiate clinical development of AXO-Lenti-PD for advanced Parkinson's disease, including our planned Phase 1/2 trial before the end of 2018;
|
•
|
initiate clinical development of AXO-AAV-OPMD for the treatment of OPMD, including our planned placebo-controlled clinical study in 2019;
|
•
|
continue the clinical development of nelotanserin for LBD and other potential indications;
|
•
|
potentially continue the clinical development of RVT-104, a combination of a peripheral muscarinic receptor antagonist and high-dose rivastigmine;
|
•
|
continue open-label extension studies for patients completing our nelotanserin phase 2 studies;
|
•
|
seek to identify, acquire, develop and commercialize additional product candidates;
|
•
|
integrate acquired technologies into a comprehensive regulatory and product development strategy;
|
•
|
achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire and retain scientific, clinical, regulatory, manufacturing, quality control, commercial and administrative personnel;
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
|
•
|
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
•
|
scale up external manufacturing capabilities to commercialize our product candidates;
|
•
|
establish a sales, marketing and distribution infrastructure for drug candidates for which we may obtain regulatory approval; and
|
•
|
operate as a public company.
|
|
Three Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Net cash used in operating activities
|
$
|
(61,413
|
)
|
|
$
|
(47,919
|
)
|
Net cash used in investing activities
|
—
|
|
|
(2,171
|
)
|
||
Net cash provided by financing activities
|
10
|
|
|
135,375
|
|
•
|
successfully commence and complete clinical trials and obtain regulatory approval for the marketing of our product candidates, including AXO-Lenti-PD and AXO-AAV-OPMD;
|
•
|
set an acceptable price for our product candidates and obtain coverage and adequate reimbursement from third-party payers;
|
•
|
establish effective sales, marketing and distribution systems for our product candidates;
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future commercialization efforts and operations as a public company;
|
•
|
initiate and continue relationships with third-party manufacturers, including Oxford BioMedica for AXO-Lenti-PD, and have commercial quantities of our product candidates manufactured at acceptable cost and quality levels;
|
•
|
attract and retain an experienced management and advisory team;
|
•
|
achieve broad market acceptance of our products in the medical community and with third-party payers and consumers;
|
•
|
launch commercial sales of our products, whether alone or in collaboration with others; and
|
•
|
maintain, expand and protect our intellectual property portfolio.
|
•
|
the process by which we identify and decide to acquire product candidates may not be successful;
|
•
|
potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance; or
|
•
|
potential product candidates may not be effective in treating their targeted diseases.
|
•
|
we may not be able to demonstrate that a product candidate is safe and effective as a treatment for our targeted indications to the satisfaction of the applicable regulatory authorities;
|
•
|
our BLA, NDA or other key regulatory filings may be delayed or rejected due to issues, including those related to the FDA’s Pharmaceutical Quality/CMC guidance, timing of results from supporting studies, database lock, and data conversion, cleaning, and transfer;
|
•
|
the regulatory authorities may require additional nonclinical studies or registrational studies of the product candidate in Parkinson’s disease or other indications, which would increase our costs and prolong our development;
|
•
|
the results of our clinical trials may not meet the level of statistical or clinical significance required for marketing approval;
|
•
|
the regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials;
|
•
|
the contract research organizations ("CROs") that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that materially adversely impact our clinical trials;
|
•
|
the regulatory authorities may not find the data from nonclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of the product candidate outweigh its safety risks;
|
•
|
the regulatory authorities may disagree with our interpretation of data from our nonclinical studies and clinical trials or may require that we conduct additional studies;
|
•
|
the regulatory authorities may not accept data generated at our clinical trial sites;
|
•
|
the regulatory authorities may require, as a condition of approval, limitations on approved labeling or distribution and use restrictions;
|
•
|
the FDA may require development of a risk evaluation and mitigation strategy ("REMS") as a condition of approval;
|
•
|
the regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers, including Oxford BioMedica, which is expected to be our sole and exclusive supplier of AXO-Lenti-PD until the process is validated or BLA submission for AXO-Lenti-PD, as well as Arena, our sole and exclusive supplier for nelotanserin, or any manufacturer that Arena may engage to manufacture nelotanserin on its behalf; or
|
•
|
the regulatory authorities may change their approval policies or adopt new regulations.
|
•
|
the progress, timing, costs and results of our clinical trials of our product candidates;
|
•
|
the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA, or the PMDA, and other comparable foreign regulatory authorities;
|
•
|
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
|
•
|
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates or any future product candidates;
|
•
|
the effect of competing technological and market developments;
|
•
|
the cost and timing of completion of commercial-scale manufacturing activities;
|
•
|
the cost of establishing sales, marketing and distribution capabilities for our product candidates in regions where we choose to commercialize our products on our own; and
|
•
|
the initiation, progress, timing and results of our commercialization of our product candidates, if approved for commercial sale.
|
•
|
multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and licenses;
|
•
|
failure by us or our distributors to obtain appropriate licenses or regulatory approvals for the sale or use of our product candidates, if approved, in various countries;
|
•
|
difficulties in managing foreign operations;
|
•
|
complexities associated with managing multiple payer-reimbursement regimes or self-pay systems;
|
•
|
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;
|
•
|
reduced protection for intellectual property rights;
|
•
|
reduced protection of contractual rights in the event of bankruptcy or insolvency of the other contracting party;
|
•
|
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions;
|
•
|
failure to comply with foreign laws, regulations, standards and regulatory guidance governing the collection, use, disclosure, retention, security and transfer of personal data, including the European Union General Data Privacy Regulation ("GDPR"), which introduces strict requirements for processing personal data of individuals within the European Union; and
|
•
|
failure to comply with the United Kingdom Bribery Act 2010 ("U.K. Bribery Act") and similar anti-bribery and anti-corruption laws in other jurisdictions, and the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, including by failing to maintain accurate information and control over sales and distributors’ activities.
|
•
|
impairment of our business reputation and significant negative media attention;
|
•
|
withdrawal of participants from our clinical trials;
|
•
|
significant costs to defend related litigation;
|
•
|
distraction of management’s attention from our primary business;
|
•
|
substantial monetary awards to patients or other claimants;
|
•
|
inability to commercialize our product candidates or any future product candidate;
|
•
|
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
decreased demand for our product candidates or any future product candidate, if approved for commercial sale; and
|
•
|
loss of revenue.
|
•
|
failure to obtain regulatory approval to commence a trial;
|
•
|
unforeseen safety issues;
|
•
|
determination of dosing issues;
|
•
|
lack of effectiveness during clinical trials;
|
•
|
inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites;
|
•
|
slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial;
|
•
|
changes in or modifications to clinical trial design;
|
•
|
failure to manufacture or obtain supply of sufficient quantities of a drug candidate or placebo or failure to obtain sufficient quantities of concomitant medication for use in clinical trials;
|
•
|
inability or unwillingness of medical investigators to follow our clinical and other applicable protocols;
|
•
|
inability to monitor patients adequately during or after treatment;
|
•
|
failure to establish sufficient number of clinical trial sites; or
|
•
|
clinical sites or others deviating from trial protocol, inappropriately unblinding results, or dropping out of a trial.
|
•
|
develop and commercialize drugs that are superior to other products in the market;
|
•
|
demonstrate through our clinical trials that our product candidates are differentiated from existing and future therapies;
|
•
|
attract qualified scientific, product development and commercial personnel;
|
•
|
obtain patent or other proprietary protection for our medicines;
|
•
|
obtain required regulatory approvals;
|
•
|
obtain coverage and adequate reimbursement from, and negotiate competitive pricing with, third-party payers; and
|
•
|
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
|
•
|
regulatory authorities may withdraw their approval of the product or require a REMS to impose restrictions on its distribution or other risk management measures;
|
•
|
regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
|
•
|
we may be required to change the way the product is administered or to conduct additional clinical trials;
|
•
|
we could be sued and held liable for harm caused to patients;
|
•
|
we could elect to discontinue the sale of our product; and
|
•
|
our reputation may suffer.
|
•
|
restrictions on manufacturing such products;
|
•
|
restrictions on the labeling or marketing of such products;
|
•
|
restrictions on product marketing, distribution or use;
|
•
|
requirements to conduct post-marketing studies or clinical trials;
|
•
|
warning or untitled letters;
|
•
|
withdrawal of the products from the market;
|
•
|
recall of products;
|
•
|
fines, restitution or disgorgement of profits or revenues;
|
•
|
suspension or withdrawal of marketing approvals;
|
•
|
refusal to permit the import or export of such products;
|
•
|
product seizure; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the efficacy and potential advantages compared to alternative treatments;
|
•
|
the effectiveness of sales and marketing efforts;
|
•
|
the cost of treatment in relation to alternative treatments, including any similar generic treatments;
|
•
|
our ability to offer our products for sale at competitive prices;
|
•
|
the convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the ethical, social and legal concerns about gene therapy;
|
•
|
the strength of marketing and distribution support;
|
•
|
the availability of third-party coverage and adequate reimbursement;
|
•
|
the prevalence and severity of any side effects; and
|
•
|
any restrictions on the use of our product together with other medications.
|
•
|
our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to physicians or attain adequate numbers of physicians to prescribe any drugs; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries;
|
•
|
reduced protection for intellectual property rights;
|
•
|
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
•
|
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
•
|
foreign reimbursement, pricing and insurance regimes;
|
•
|
foreign taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
•
|
potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and similar anti-bribery and anti-corruption laws in other jurisdictions;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
|
•
|
the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;
|
•
|
the federal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly making, or causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information on health plans, health care clearing houses, and most providers and their business associates, defined as independent contractors or agents of covered entities that create, receive or obtain protected health information in connection with providing a service for or on behalf of a covered entity;
|
•
|
a number of federal, state and foreign laws, regulations, guidance and standards that impose requirements regarding the protection of health or other personal data that are applicable to or affect our operations;
|
•
|
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other "transfers of value" made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other "transfers of value" to such physician owners (covered manufacturers are required to submit reports to the government by the 90th day of each calendar year); and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, as well as state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
•
|
an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents;
|
•
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
|
•
|
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% commencing January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries under their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations;
|
•
|
expansion of eligibility criteria for Medicaid programs in certain states;
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
•
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
failure to satisfy their contractual duties or obligations;
|
•
|
inability to meet our product specifications and quality requirements consistently;
|
•
|
delay or inability to procure or expand sufficient manufacturing capacity;
|
•
|
manufacturing and/or product quality issues related to manufacturing development and scale-up;
|
•
|
costs and validation of new equipment and facilities required for scale-up;
|
•
|
failure to comply with applicable laws, regulations and standards, including cGMP and similar foreign standards;
|
•
|
deficient or improper record-keeping;
|
•
|
contractual restrictions on our ability to engage additional or alternative manufacturers;
|
•
|
inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
|
•
|
termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
|
•
|
reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates or any future product candidate in a timely fashion, in sufficient quantities or under acceptable terms;
|
•
|
lack of access or licenses to proprietary manufacturing methods used by third-party manufacturers to make our product candidates;
|
•
|
lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
|
•
|
operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or regulatory sanctions related to the manufacture of our or other company’s products;
|
•
|
carrier disruptions or increased costs that are beyond our control; and
|
•
|
failure to deliver our products under specified storage conditions and in a timely manner.
|
•
|
collaborators have significant discretion in determining the amount and timing of the efforts and resources that they will apply to these collaborations;
|
•
|
collaborators may not perform their obligations as expected;
|
•
|
the nonclinical studies and clinical trials conducted as part of these collaborations may not be successful;
|
•
|
collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on nonclinical study or clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;
|
•
|
collaborators may delay nonclinical studies and clinical trials, provide insufficient funding for nonclinical studies and clinical trials, stop a nonclinical study or clinical trial or abandon a product candidate, repeat or conduct new nonclinical studies or clinical trials or require a new formulation of a product candidate for nonclinical studies or clinical trials;
|
•
|
we may not have access to, or may be restricted from disclosing, certain information regarding product candidates being developed or commercialized under a collaboration and, consequently, may have limited ability to inform our stockholders about the status of such product candidates;
|
•
|
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
•
|
product candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;
|
•
|
a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any such product candidate;
|
•
|
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development of any product candidates, may cause delays or termination of the research, development or commercialization of such product candidates, may lead to additional responsibilities for us with respect to such product candidates or may result in litigation or arbitration, any of which would be time consuming and expensive;
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
|
•
|
disputes may arise with respect to the ownership or inventorship of intellectual property developed pursuant to our collaborations;
|
•
|
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
|
•
|
the terms of our collaboration agreement may restrict us from entering into certain relationships with other third parties, thereby limiting our options; and
|
•
|
collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.
|
•
|
the scope of rights granted under the agreement and other interpretation-related issues;
|
•
|
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the agreement;
|
•
|
our right to sublicense patent and other rights to third parties;
|
•
|
our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;
|
•
|
the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;
|
•
|
our right to transfer or assign our license; and
|
•
|
the effects of termination.
|
•
|
others may be able to make products that are the same as or similar to our product candidates, but that are not covered by the claims of the patents or other intellectual property rights that we own that we have exclusively licensed and have the right to enforce;
|
•
|
we, our licensor or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own;
|
•
|
we or our licensor might not have been the first to file patent applications covering certain of our inventions;
|
•
|
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
|
•
|
it is possible that our pending patent applications will not lead to issued patents;
|
•
|
issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
|
•
|
our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; and
|
•
|
we may not develop additional proprietary technologies that are patentable.
|
•
|
any additional delays in the commencement, enrollment and ultimate completion of our clinical trials;
|
•
|
results of clinical trials of our product candidates or those of our competitors, such as our announcement of the failure of our Phase 2B HEADWAY clinical trial of intepirdine in patients with DLB and the pilot Phase 2 Gait and Balance clinical trial of intepirdine in patients with dementia and gait impairment to meet their respective primary endpoints and the September 2017 announcement that our Phase 3 MINDSET clinical trial of intepirdine in patients with mild-to-moderate Alzheimer's disease did not meet its co-primary efficacy endpoints;
|
•
|
any delay in filing applications for marketing approval of AXO-Lenti-PD or AXO-AAV-OPMD, and any adverse development or perceived adverse development with respect to applicable regulatory authorities’ review of those applications;
|
•
|
failure to successfully develop and commercialize AXO-Lenti-PD, AXO-AAV-OPMD or any other of our current or future product candidates;
|
•
|
failure to maintain our relationship with Oxford BioMedica or Benitec or comply with the terms of the Oxford BioMedica Agreement or the Benitec Agreement;
|
•
|
inability to obtain additional funding;
|
•
|
regulatory or legal developments in the United States and other countries applicable to our product candidates, including gene therapies;
|
•
|
adverse regulatory decisions or statements;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
inability to obtain adequate product supply for our current product candidates or any future product candidate, or the inability to do so at acceptable prices;
|
•
|
introduction of new products, services or technologies by our competitors;
|
•
|
failure to meet or exceed financial projections we provide to the public;
|
•
|
failure to meet or exceed the estimates and projections of the investment community;
|
•
|
changes in the market valuations of similar companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
significant lawsuits, including patent or shareholder litigation, and disputes or other developments relating to our proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
short sales of our common shares;
|
•
|
sales of our common shares by us or our shareholders in the future;
|
•
|
negative coverage in the media or analyst reports, whether accurate or not;
|
•
|
issuance of subpoenas or investigative demands, or the public fact of an investigation by a government agency, whether meritorious or not;
|
•
|
trading volume of our common shares;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this "Risk Factors" section.
|
•
|
that a majority of its board of directors consists of independent directors;
|
•
|
for an annual performance evaluation of the nominating and corporate governance and compensation committees;
|
•
|
to require director nominees to be selected, or recommended for the board of directors’ selection, either by independent directors constituting a majority of the Board’s independent directors in a vote in which only independent directors participate or a nominations committee comprised solely of independent directors; and
|
•
|
to have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibility.
|
|
|
|
Incorporated by Reference
|
|||
Exhibit
Number
|
|
Description of Document
|
Schedule/Form
|
File No.
|
Exhibit
|
Filing Date
|
|
|
|
|
|
|
|
3.1
|
|
S-1
|
333-204073
|
3.1
|
05/11/2015
|
|
|
|
|
|
|
|
|
3.2
|
|
S-1
|
333-204073
|
3.2
|
05/11/2015
|
|
|
|
|
|
|
|
|
3.3
|
|
8-K
|
001-37418
|
3.1
|
12/21/2017
|
|
|
|
|
|
|
|
|
10.1*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.3*+
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.4
|
|
8-K
|
001-37418
|
1.1
|
06/22/2018
|
|
|
|
|
|
|
|
|
31.1*
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|
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|
31.2*
|
|
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|
32.1*#
|
|
|
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32.2*#
|
|
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101.INS*
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH*
|
|
XBRL Taxonomy Extension Schema
|
|
|
|
|
|
|
|
|
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101.CAL*
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
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|
|
|
|
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101.DEF*
|
|
XBRL Taxonomy Extension Definition Linkbase
|
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|
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|
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101.LAB*
|
|
XBRL Taxonomy Extension Label Linkbase
|
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101.PRE*
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XBRL Taxonomy Extension Presentation Linkbase
|
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|
|
AXOVANT SCIENCES LTD.
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Gregory Weinhoff
|
Date
|
August 7, 2018
|
|
Gregory Weinhoff
(Duly Authorized Officer and Principal Financial Officer)
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
Article 1 DEFINITIONS AND INTERPRETATION
|
|
||
Section 1.01
|
Definitions.
|
1
|
|
Section 1.02
|
Additional Defined Terms
|
8
|
|
Section 1.03
|
Other Definitional and Interpretive Matters
|
9
|
|
Article 2 RIGHT OF FIRST REVIEW
|
|
||
Section 2.01
|
.
|
10
|
|
Article 3 FINANCIAL REPORTING AND DISCLOSURE COVENANTS
|
|
||
Section 3.01
|
Financial Reporting and Controls
|
10
|
|
Section 3.02
|
Private Company Information Rights
|
20
|
|
Article 4 COMPLIANCE COVENANTS
|
|
||
Section 4.01
|
Compliance
|
20
|
|
Article 5 EXCHANGE OF INFORMATION; CONFIDENTIALITY
|
|
||
Section 5.01
|
Privilege
|
26
|
|
Section 5.02
|
Ownership of Information.
|
26
|
|
Section 5.03
|
Record Retention
|
26
|
|
Section 5.04
|
Limitation of Liability
|
26
|
|
Section 5.05
|
Confidentiality
|
26
|
|
Section 5.06
|
Protective Arrangements
|
29
|
|
Section 5.07
|
Preservation of Legal Privileges
|
29
|
|
Article 6 TAX MATTERS.
|
|
||
Section 6.01
|
PFIC
|
30
|
|
Section 6.02
|
QEF Information
|
31
|
|
Article 7 DISPUTE RESOLUTION
|
|
||
Section 7.01
|
Limitation on Monetary Damages Equitable Remedies.
|
31
|
|
Section 7.02
|
Disputes.
|
31
|
|
Section 7.03
|
Escalation; Mediation.
|
32
|
|
Section 7.04
|
Binding Arbitration.
|
33
|
|
Article 8 FURTHER ASSURANCES
|
|
||
Section 8.01
|
Further Assurances.
|
35
|
|
Article 9 MISCELLANEOUS
|
|
||
Section 9.01
|
Counterparts; Entire Agreement; Conflicting Agreements.
|
36
|
|
Section 9.02
|
No Construction Against Drafter.
|
37
|
|
Section 9.03
|
Governing law.
|
37
|
|
Section 9.04
|
Assignability
|
37
|
|
Section 9.05
|
Notices
|
37
|
|
Section 9.06
|
Severability
|
40
|
|
Section 9.07
|
Force Majeure
|
41
|
|
Section 9.08
|
Headings.
|
41
|
|
Section 9.09
|
Termination; Survival.
|
41
|
|
Section 9.10
|
Waivers of Default.
|
41
|
|
Section 9.11
|
Specific Performance
|
41
|
|
Section 9.12
|
Amendments
|
42
|
|
Section 9.13
|
Waiver of Jury Trial
|
42
|
|
Section 9.14
|
Limitation on Monetary Damages
|
43
|
|
Section 9.15
|
Indemnity and Expenses
|
43
|
|
Section 9.16
|
Maintenance of Insurance
|
44
|
|
Section 9.17
|
No Third-Party Beneficiaries
|
45
|
|
Section 9.18
|
Expenses
|
45
|
|
TERM
|
SECTION
|
|
|
Acceptance Notice
|
2.01
|
Agreement
|
Preamble
|
Annual Financial Statements
|
3.01(c)
|
Company
|
Preamble
|
Dementia Opportunity
|
2.01
|
Effective Date
|
Recitals
|
Expert Councils
|
4.01(e)
|
Indemnified Liabilities
|
9.15(a)(i)
|
Indemnitees
|
9.15(a)(i)
|
Offer Notice
|
2.01
|
Original Agreement
|
Recitals
|
Original Effective Date
|
Recitals
|
Policies
|
4.01(a)
|
Privilege
|
5.01
|
Quarterly Financial Statements
|
3.01(b)(i)
|
Roivant
|
Preamble
|
(d)
|
Compliance with Law
.
|
(a)
|
Indemnity
.
|
COMPANY:
|
|
|
|
AXOVANT SCIENCES LTD.
|
|
|
|
By:
|
/s/ Gregory Weinhoff
|
Name:
|
Gregory Weinhoff
|
Title:
|
Principal Financial Officer
|
SHAREHOLDER:
|
|
|
|
ROIVANT SCIENCES LTD.
|
|
|
|
By:
|
/s/ Marianne Romeo
|
Name:
|
Marianne Romeo
|
Title:
|
Head, Global Transactions & Risk Management
|
COMPANY:
|
|
|
|
AXOVANT SCIENCES LTD.
|
|
|
|
By:
|
/s/ Gregory Weinhoff
|
Name:
|
Gregory Weinhoff
|
Title:
|
Principal Financial Officer
|
SHAREHOLDER:
|
|
|
|
ROIVANT SCIENCES LTD.
|
|
|
|
By:
|
/s/ Marianne Romeo
|
Name:
|
Marianne Romeo
|
Title:
|
Head, Global Transactions & Risk Management
|
To the Company:
|
Axovant Sciences Ltd.
|
|
Suite 1, 3
rd
Floor
11-12 St. James’s Square
London SW1Y 4LB, United Kingdom
Attention: Gregory Weinhoff, Principal Financial Officer
Email: gregory.weinhoff@axovant.com
|
With a copy (which
|
Cooley LLP
|
shall not constitute
notice to the Company):
|
3175 Hanover Street
Palo Alto, CA 94304
|
|
|
|
Attention:Frank Rahmani
(650) 843-5753
Email:
rahmaniff@cooley.com
John T. McKenna
(650) 843-5059
Email:
jmckenna@cooley.com
|
To the Investor:
|
Roivant Sciences Ltd.
|
|
Suite 1, 3
rd
Floor
11-12 St. James’s Square
London SW1Y 4LB, United Kingdom
|
|
Attention: Allen Waxman, General Counsel
Email:
allen.waxman@roivant.com
|
With a copy to (which
|
White & Case LLP
|
shall not constitute
|
1221 Avenue of the Americas
|
notice to the Investor):
|
New York, New York 10020
|
|
Attention: Chang-Do Gong
(212) 819-7808
Email: cgong@whitecase.com
|
(1)
|
OXFORD BIOMEDICA (UK) LTD, a company incorporated in England and registered under number 03028927, whose registered office is at Windrush Court, Transport Way,
|
(2)
|
AXOVANT SCIENCES GMBH, a company organized and existing under the laws of Switzerland, having its principal place of business at Viaduktstrasse 8, 4051 Basel, Switzerland (the “Licensee”).
|
(A)
|
BioMedica has special expertise and longstanding experience in the field of lentiviral vector gene therapy products, including pre-clinical and clinical development, manufacture, testing and product release.
|
(B)
|
BioMedica has developed and controls certain intellectual property rights relating to lentiviral vectors for dopamine replacement therapy, including OXB-102, Prosavin and alternative vectors, and certain intellectual property rights useful for the production and use of lentiviral vectors in human cells.
|
(C)
|
The Licensee wishes to take, and BioMedica wishes to grant, an exclusive licence under intellectual property rights of BioMedica to develop and commercialise certain products, and to engage BioMedica to perform certain development work relating to the manufacture of such products on the terms of this Agreement.
|
1.
|
DEFINITIONS
|
1.1
|
In this Agreement, the following terms have the meanings set forth in this Clause 1.1 (Definitions):
|
(a)
|
“Accompanying Innovative Product” shall have the meaning set out in
Schedule 5
(Net Sales).
|
(b)
|
“Accounting Standards” shall mean internationally recognised accounting principles (including IFRS, US GAAP, and the like), in each case, as generally and consistently applied by the applicable Selling Entity.
|
(c)
|
“Affiliate” shall mean:
|
(i)
|
with respect to the Licensee, any entity or any other person that controls, is controlled by, or is under common control with, the Licensee, but excluding Roivant Sciences Ltd., a company organized under the laws of Bermuda (“Roivant”), and any entity or any other person controlled by, or under common control with, Roivant other than through the intermediary of Axovant Sciences Ltd., and for the avoidance of doubt, the Licensee’s Affiliates as of the Effective Date are Axovant Holdings Limited, a company organized under the laws of England and Wales,
|
(ii)
|
with respect to BioMedica, any entity or other person that controls, is controlled by, or is under common control with, BioMedica; and
|
(iii)
|
with respect to any Third Party, any entity or other person that controls, is controlled by, or is under common control with, such Third Party;
|
(d)
|
“Alternative Product” shall mean in relation to a Product:
|
(i)
|
any gene therapy product:
|
(A)
|
designed to produce proteins having the enzymatic or cofactor activities of all of the transgenes delivered by the Product; and
|
(B)
|
delivering no other therapeutic moiety; or
|
(ii)
|
a Biosimilar Product.
|
(e)
|
“Annual Net Sales” shall mean the [***].
|
(f)
|
“Applicable Laws” shall mean the applicable provisions of any and all national, supranational, regional, state and local laws (including common law or other binding law), statutes, regulations, codes, directives, injunctions, orders, permits of or from any court, arbitrator, Regulatory Authority or governmental agency or authority having jurisdiction over or related to the subject item, together with all applicable current international regulatory requirements and standards, such as Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices and comparable foreign regulatory standards.
|
(g)
|
“Axovant Sciences Ltd.” shall mean Axovant Sciences Ltd., a company organized under the laws of Bermuda.
|
(h)
|
“Backup Product” shall mean any lentiviral-based vector product for delivering:
|
(i)
|
transgenes, which transgenes encode proteins having the enzymatic or cofactor activities of either one or two (but not three) of the following: AADC (aromatic L-amino acid decarboxylase), TH (tyrosine hydroxylase), or CH1 (GTP cyclohydrolase 1); and
|
(ii)
|
no other therapeutic moiety;
|
(i)
|
“BioMedica Competing Product” shall mean:
|
(i)
|
any product for delivering transgenes, in a lentiviral-based vector, which transgenes encode proteins having the enzymatic or cofactor activities of any one or two or three of the following: AADC (aromatic L-amino acid decarboxylase), TH (tyrosine hydroxylase), or CH1 (GTP cyclohydrolase 1), in each case either alone or in combination with other therapeutic moieties, but excluding a BioMedica Reserved Product, and
|
(ii)
|
any product for delivering transgenes, in a lentiviral-based vector, which transgenes encode proteins having the enzymatic or cofactor activities of all three (3) of the following: AADC (aromatic L-amino acid decarboxylase), TH (tyrosine hydroxylase), and CH1 (GTP cyclohydrolase 1), and any other therapeutic moiety where the therapeutic effect of such product is the increased production of dopamine.
|
(j)
|
“BioMedica Indemnitees” shall have the meaning set forth in Clause 14.2 (Licensee Indemnification).
|
(k)
|
“BioMedica IP” shall mean:
|
(i)
|
the Patents that Cover the development, manufacture, use, or commercialization of the Products, including those Patents identified in Part 1 and Part 2 of
Schedule 1
(the “Licensed Patents”);
|
(ii)
|
the Know-How that is necessary or reasonably useful for the research, development, use, offering for sale, sale, import, and export of Products, but excluding Know-How for the Manufacture of Products (which is described in Clause 1.1(k)(iii) (BioMedica IP)); and
|
(iii)
|
the Know-How that is reasonably useful (that exists as of the date of transfer pursuant to Clause 7.3 (Technology Transfer)) or that is necessary (that exists at any time during the Term) to practice the process transferred to the Licensee or its designee pursuant to Clause 7.3 (Technology Transfer) for Manufacture of Products;
|
(l)
|
“BioMedica Qualified Person” shall mean the person with legal responsibility to certify that each batch of medicinal product for human or veterinary use within the European Union has been manufactured, tested in accordance with all Applicable Laws and all safety and quality requirements of the clinical trial
|
(m)
|
“BioMedica Reserved Product” shall mean any lentiviral-based vector product for delivering:
|
(i)
|
transgenes, which transgenes encode proteins having the enzymatic or cofactor activities of all three (3) of: AADC (aromatic L-amino acid decarboxylase), TH (tyrosine hydroxylase), and CH1 (GTP cyclohydrolase 1); and
|
(ii)
|
any other therapeutic moiety;
|
(n)
|
“BioMedica TRiP Know-How” shall mean Know-How Controlled by BioMedica as of the Effective Date or generated or acquired by BioMedica after the Effective Date, in each case, with respect to the TRiP System.
|
(o)
|
“BioMedica TRiP Patents” shall mean the Patents Controlled by BioMedica that Cover the TRiP System and shall include the Patents listed in Part 3 of
Schedule 1
which may be updated by BioMedica from time to time with additional Patents.
|
(p)
|
“Biosimilar Product” means a pharmaceutical product that, with respect to a Product, (i) has been licensed as a biosimilar or interchangeable product by the FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, statute, or regulation, (ii) has been licensed as a similar biological medical product by the EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute, or regulation, or (iii) has otherwise achieved analogous Regulatory Approval from another applicable Regulatory Authority.
|
(q)
|
“BLA” shall mean (i) a Biologics License Application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) or equivalent submission filed with the FDA seeking Regulatory Approval, or (ii) any equivalent application to a Regulatory Authority in any other country, including a marketing authorisation application (“MAA”) filed with the EMA.
|
(r)
|
“Business Day” shall mean any day except a Saturday, Sunday or any other day when commercial banks in London, England, New York City, New York or Basel, Switzerland are authorised to close.
|
(s)
|
“Calendar Quarter” shall mean each respective period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31.
|
(t)
|
“Calendar Year” shall mean any period of twelve consecutive months beginning on 1 January and ending on 31 December.
|
(u)
|
“Change of Control of BioMedica” shall mean the occurrence of any of the following:
|
(i)
|
any reorganization, recapitalization, consolidation, amalgamation or merger (or similar transaction or series of related transactions) of Oxford BioMedica plc, or any sale or exchange of outstanding shares (or similar transaction or series of related transactions) of Oxford BioMedica plc, and in each case as a result of such transaction, any person or group of persons who are connected persons of each other or who are acting in concert owns, directly or indirectly, shares representing more than [***] of the voting power of Oxford BioMedica plc or such surviving entity;
|
(ii)
|
as a result of a tender or exchange offer, open market purchases, privately negotiated purchases, consolidation, merger or otherwise, any person or group of persons who are connected persons of each other or who are acting in concert owns, directly or indirectly, shares representing more than [***] of the voting power of Oxford BioMedica plc;
|
(iii)
|
Oxford BioMedica plc ceases to control BioMedica;
|
(iv)
|
the sale, transfer or other disposition (including by way of merger or consolidation) of all or substantially all of the business and assets of Oxford BioMedica plc and its Affiliates, taken as a whole, to one or more Third Parties whether through a single transaction or a series of transactions; or
|
(v)
|
the shareholders of Oxford BioMedica plc. adopt a plan or proposal for liquidation or dissolution of Oxford BioMedica plc.
|
(v)
|
“Change of Control of the Licensee” shall mean the occurrence of any of the following:
|
(i)
|
any reorganization, recapitalization, consolidation, amalgamation or merger (or similar transaction or series of related transactions) of Axovant Sciences Ltd., or any sale or exchange of outstanding shares (or similar transaction or series of related transactions) of Axovant Sciences Ltd., and in each case as a result of such transaction Roivant ceases to own, directly or indirectly, shares representing more than [***] of the voting power of Axovant Sciences Ltd. or the surviving entity of such transaction or series of related transactions, in each case without regard to whether Axovant Sciences Ltd. is the surviving entity and, in each case, any person or group of persons who are connected persons of each other or who are acting in concert, in each case other than Roivant, owns, directly or indirectly, shares representing more than [***] of the voting power of Axovant Sciences Ltd. or such surviving entity;
|
(ii)
|
as a result of a tender or exchange offer, open market purchases, privately negotiated purchases, consolidation, merger or otherwise, any person or group of persons who are connected persons of each other or
|
(iii)
|
Axovant Sciences Ltd. ceases to control the Licensee, other than in connection with a Group Reorganisation;
|
(iv)
|
the sale, transfer or other disposition (including by way of merger or consolidation) of all or substantially all of the business and assets of Axovant Sciences Ltd. and its Affiliates, taken as a whole, to one or more Third Parties (other than Roivant or its Affiliates) whether through a single transaction or a series of transactions; or
|
(v)
|
the shareholders of Axovant Sciences Ltd. adopt a plan or proposal for liquidation or dissolution of Axovant Sciences Ltd.
|
(w)
|
“Change Proposal” shall have the meaning set out in Clause 5.1(c) (Process Development Services).
|
(x)
|
“Charge” shall have the meaning set out in Clause 16.1(a)(ii) (Term Loan Agreement).
|
(y)
|
“Claim” shall have the meaning set out in Clause 14.2 (Licensee Indemnification).
|
(z)
|
“Clinical Project Team” shall have the meaning set out in Clause 3.1 (Clinical Project Team).
|
(i)
|
as would normally be used or employed by a reasonable Third Party company having, together with its Affiliates, similar financial and other resources as the Licensee together with its Affiliates;
|
(ii)
|
for a product of similar market potential at a similar stage of its product life as the relevant Product;
|
(iii)
|
when utilizing sound and reasonable scientific, medical, and business judgment to develop and commercialise such product in a timely manner;
|
(iv)
|
taking into account relative safety and efficacy, product profile, the competitiveness of the marketplace and the market potential of such
|
(v)
|
but in all cases without taking into account the fact that an alternative competing product is being developed or commercialised by or on behalf of such reasonable Third Party company or one of its Affiliates or sublicensees.
|
(i)
|
the existence and terms of this Agreement for which both Parties shall be deemed to be the Receiving Party;
|
(ii)
|
information disclosed under the confidentiality agreement between the Parties originally executed 15
th
November 2017, amended on 7
th
December 2017 (the “CDA”), which, with effect from the Effective Date, shall be deemed to be Confidential Information of the relevant Party under this Agreement and subject to the terms of this Agreement in place of the terms of the CDA with this Agreement superseding the CDA; and
|
(iii)
|
the Know-How within the BioMedica IP for which BioMedica shall be deemed to be the Disclosing Party and the Licensee deemed to be the Receiving Party.
|
(xx)
|
“FTE Rate” shall mean a rate of £[***] per FTE per year, to be pro-rated on an hourly basis of £[***] per FTE per hour, assuming [***] hours per year for an FTE.
|
(i)
|
that Party ceasing or threatening to cease to carry on business;
|
(ii)
|
that Party being deemed by a competent authority to be unable or admitting inability to pay its debts;
|
(iii)
|
a moratorium is declared by a competent authority in respect of any indebtedness of that Party;
|
(iv)
|
that Party giving notice to any of its creditors that it has suspended or is about to suspend payment of any of its debts;
|
(v)
|
that Party commencing negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness by reason of financial difficulties;
|
(vi)
|
an arrangement, composition, or assignment with or for the benefit of its creditors is entered into or proposed by or in relation to that Party;
|
(vii)
|
a receiver, administrative receiver, liquidator, or compulsory manager taking possession of or being appointed over the whole or any material part of the assets of that Party;
|
(viii)
|
any expropriation, attachment, sequestration, distress, execution or other analogous process is levied or enforced on or affects the whole or any material part of the assets of that Party (and is not discharged within [***]);
|
(ix)
|
enforcement of any mortgage, charge, pledge, lien or other security interest securing any obligation of any person or any other agreement or arrangement having a similar effect over any assets of that Party;
|
(x)
|
that Party or its directors or the holder of a qualifying floating charge giving notice of his, their or its intention to appoint an administrator;
|
(xi)
|
that Party or its directors or any of its creditors or the holder of a qualifying floating charge making an application to the court for the appointment of an administrator;
|
(xii)
|
an administrator being appointed of that Party;
|
(xiii)
|
the winding-up, dissolution, administration or reorganisation (by way of voluntary arrangement, scheme of arrangement or otherwise) with respect to that Party; provided that this does not apply to any winding-up petition that is frivolous or vexatious and is discharged, stayed or dismissed within [***] of commencement;
|
(xiv)
|
that Party being struck off the register of companies; or
|
(xv)
|
the happening in relation to that Party of an event analogous to any of the above in any jurisdiction in which it is incorporated or resident or in which it carries on business or has assets.
|
(iii)
|
“Know-How” shall mean unpatented technical and other information which is not generally known, including information comprising or relating to discoveries, inventions, data, designs, formulae, methods, models, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including manufacturing processes, specification and techniques), laboratory records, chemical, pharmacological, toxicological, pre-clinical, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports or summaries and information contained in submissions to and information from ethical committees and regulatory authorities.
|
(i)
|
in any vector other than a lentiviral-based vector; and
|
(ii)
|
which transgenes encode proteins having the enzymatic or cofactor activities of either one or two or three of the following: AADC (aromatic L-amino acid decarboxylase), TH (tyrosine hydroxylase), or CH1 (GTP cyclohydrolase 1).
|
(i)
|
a material finding regarding the safety or efficacy of the Product; or
|
(ii)
|
a material development regarding the commercial viability of the Product;
|
(i)
|
[***];
|
(ii)
|
[***];
|
(iii)
|
[***];
|
(xxx)
|
“Original Product” shall mean any lentiviral-based vector product for delivering:
|
(i)
|
transgenes, which transgenes encode proteins having the enzymatic or cofactor activities of all of AADC (aromatic L-amino acid decarboxylase),
|
(ii)
|
no other therapeutic moiety;
|
(cccc)
|
“Paediatric Priority Review Voucher” shall mean a priority review voucher awarded by the FDA to the sponsor of a rare paediatric disease product application pursuant to Section 529 of the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended, and the rules and regulations promulgated thereunder, or an equivalent voucher under a superseding law.
|
(dddd)
|
“Paediatric Priority Review Voucher Receipts” shall mean any payments received by the Licensee or its Affiliates pursuant to one or more agreements relating to the transfer by the Licensee or its Affiliates to a Third Party of a Paediatric Priority Review Voucher.
|
(eeee)
|
“Party” shall mean BioMedica or the Licensee and, when used in the plural, shall mean BioMedica and the Licensee.
|
(ffff)
|
“Patents” shall mean (i) pending patent applications, issued patents, utility models and designs; (ii) all reissues, extensions (including patent term adjustments and supplementary protection certificates), substitutions, confirmations, registrations, re-registrations, re-examinations, continuations, continuations-in-part, divisions, and patents of addition, with respect to the foregoing; and (iii) extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificates or the equivalent thereof.
|
(hhhh)
|
“Phase 1/2 Clinical Trial” shall mean, in reference to a clinical trial of a Product, that such trial combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial of such Product into a single protocol, where the Phase 1 Clinical Trial portion is performed first to (i) establish initial safety, tolerability, pharmacokinetic and pharmacodynamic information for a Product or (ii) determine an optimal dose of such Product in subjects, and the Phase 2 Clinical Trial portion is performed second to further evaluate safety and efficacy of such Product in subjects treated with a selected dose.
|
(iiii)
|
“Phase 2 Clinical Trial” shall mean, in reference to a clinical trial of a Product,
|
(jjjj)
|
“Pivotal Clinical Trial” shall mean a controlled clinical study in humans of the efficacy and safety of a product, that is (1) prospectively designed to, or (2) for the purposes of Clause 8.2 (Development and Regulatory Milestone Payments) is subsequently determined to, demonstrate statistically whether such product is effective and safe for use in humans in the indication being investigated in a manner sufficient to submit a BLA to obtain Regulatory Approval to market such product, in each case as evidenced by (i) an agreement with or statement from the FDA on a Special Protocol Assessment or equivalent in another country, or
|
(i)
|
an Original Product; or
|
(ii)
|
pursuant to Clause 2.1(c) (Grant of Licence; Right of Reference), any Backup Product;
|
(bbbbb)
|
“Royalty Term” shall mean, in relation to a Product sold in a country, the period of time from the First Commercial Sale by a Selling Entity of such Product in such country until the latest of (i) the date upon which there is no Valid Claim in such country that Covers such Product (provided that in the event that a pending claim within the BioMedica IP is subsequently granted following expiry of the Royalty Term under this paragraph, the Royalty Term shall come back into force to the extent that such claim is a Valid Claim that Covers such Product); (ii) the expiry of any Regulatory Exclusivity in respect of such Product in such country; and (iii) ten (10) years after such First Commercial Sale of such Product in such country.
|
(ddddd)
|
“Selling Entity” shall mean the Licensee, its Affiliates, or Sublicensees, as applicable.
|
(eeeee)
|
“Senior Officers” shall mean, for the Licensee, the President, and for BioMedica, the Chief Executive Officer.
|
(ggggg)
|
“Sublicensee” shall mean a Third Party to whom the Licensee, its Affiliates, or its or their Sublicensee has granted rights under the BioMedica IP, including through multiple tiers.
|
(hhhhh)
|
“Tax” or “Taxes” means any and all federal, provincial, territorial, state, municipal, local, foreign or other taxes, imposts, rates, levies, assessments and other charges in the nature of a tax, including without limitation all income,
|
(ooooo)
|
“Valid Claim” shall mean a claim of (i) an unexpired and issued patent within the BioMedica IP that has not been disclaimed, revoked, or held invalid, unpatentable or unenforceable by an administrative agency, court or other government agency of competent jurisdiction in a final and non-appealable decision (or a decision unappealed within the time limit allowed for appeal), and which has not been admitted to be invalid or unenforceable through reissue, re- examination or disclaimer or otherwise; or (ii) a pending patent application within the BioMedica IP which has not been finally rejected by a patent office or other governmental agency of competent jurisdiction in an unappealable decision or a decision that is un-appealed within the time allowed for appeal and has not been pending for more than five (5) years from the date of filing of such pending patent application.
|
(ppppp)
|
“Value Added Tax” or “VAT” means the tax imposed by Council Directive 2006/112/EC of the European Community and any national legislation implementing that directive together with legislation supplemental thereto and in particular, in relation to the United Kingdom, the tax imposed by the Value Added Tax Act of 1994 or other tax of a similar nature imposed elsewhere instead of or in addition to value added tax; and outside the European Union (and including the United Kingdom in the event that the United Kingdom ceases to be a member of the European Union during the Term), any tax corresponding to, or substantially similar to, the common system of value added tax referred to in this definition, excluding any Tax imposed on or with respect to the income of any of BioMedica or its Affiliates.
|
(qqqqq)
|
“Work Package” shall mean any written statement setting out a programme of process development work to be performed under this Agreement and containing the information set out in
Schedule 3
and such other information as may be necessary for the performance of such programme of work.
|
1.2
|
Interpretation. In this Agreement:
|
(a)
|
unless otherwise specified, references to clauses and schedules are to the clauses and schedules of this Agreement;
|
(b)
|
the words “include”, “including” and “in particular” are to be construed as being by way of illustration or emphasis only and are not to be construed so as to limit the generality of any words preceding them;
|
(c)
|
the words “other” and “otherwise” are not to be construed as being limited by any words preceding them;
|
(d)
|
headings are used for convenience only and do not affect its interpretation; and
|
(e)
|
a reference to the singular includes a reference to the plural and vice versa and a reference to any gender includes a reference to all other genders.
|
2.
|
GRANT OF LICENCE
|
2.1
|
Grant of Licence; Right of Reference
|
(a)
|
BioMedica hereby grants to the Licensee, subject to the terms and conditions set forth in this Agreement, a worldwide, exclusive (even as to BioMedica, except as expressly set forth herein) license, with the right to grant sublicenses (including through one or multiple tiers) under the BioMedica IP to research, develop, Manufacture and have Manufactured (subject to Clause 7 (Manufacture) with respect to Manufacture of Products), use, offer for sale, sell, have sold, import, and export the Products in the Field.
|
(b)
|
BioMedica hereby grants to the Licensee, its Affiliates, and Sublicensees, subject to the terms and conditions set forth in this Agreement, a “Right of Reference” as that term is defined in 21 C.F.R. § 314.3(b) (or any other similar provision under Applicable Law outside the US) to all regulatory documents, dossiers and filings that relate to the Product or any lentiviral vector gene therapy product manufactured by BioMedica, provided that:
|
(i)
|
such right shall apply only to such regulatory documents, dossiers or filings to which BioMedica is able to grant such “Right of Reference” without violating the terms of any agreement or other arrangements with any Third Party or misappropriating the proprietary or trade secret information of a Third Party; and
|
(ii)
|
such right shall be for the sole purpose of enabling the Licensee its Affiliates, and Sublicensees to file, obtain approval and maintain any Regulatory Filings with respect to the Products or exercise any of its license rights to Products.
|
(c)
|
If the Licensee considers that a Material Issue has arisen, the Licensee shall immediately notify BioMedica in writing providing all available details of the Material Issue. Following such notification, the Parties shall discuss the nature of the Material Issue in good faith. If, following such discussion the Licensee maintains its opinion that there is a Material Issue, then the definition of Product shall be deemed to mean only a Backup Product and shall not include an Original Product.
|
(d)
|
BioMedica and its Affiliates shall not, alone or in collaboration with any Third Party, clinically develop, seek Regulatory Approval for, Manufacture (or have Manufactured), use, sell (or have sold), market, promote, import, export, or otherwise commercialize (or grant any rights in or to) an Original Product or a Backup Product during the Term.
|
(e)
|
BioMedica shall, from time to time but at least annually on the anniversary of the Effective Date, update Part 1 and Part 2 of
Schedule 1
to include any additional Patents Controlled by BioMedica that Cover the development, manufacture, use, or commercialization of the Products, excluding the BioMedica TRiP Patents unless and until the Licensee exercises its option pursuant to Clause 2.2(a) (TRiP and WPRE Option) and the WPRE Patent unless and until the Licensee exercises its option pursuant to Clause 2.2(b) (TRiP and WPRE Option).
|
2.2
|
TRiP and WPRE Option.
|
(a)
|
BioMedica hereby grants to the Licensee an exclusive option to obtain a worldwide, exclusive licence, with the right to grant sublicenses (including through multiple tiers) under the BioMedica TRiP Patents and the BioMedica TRiP Know-How solely to research, develop, Manufacture and have Manufactured (subject to Clause 7 (Manufacture) with respect to Manufacture of Products) use, offer for sale, sell, have sold, import, and export the Products in the Field (“TRiP Option”). The Licensee may exercise the TRiP Option by written notice to BioMedica. Upon exercise of the TRiP Option, the licence under the BioMedica TRiP Patents and the BioMedica TRiP Know-How shall be deemed part of the definition of “BioMedica IP”.
|
(b)
|
BioMedica hereby grants to the Licensee an exclusive option to obtain a worldwide, non-exclusive licence, without the right to grant sublicenses under the WPRE Patent solely to research, develop, Manufacture and have Manufactured (subject to Clause 7 (Manufacture) with respect to Manufacture of Products) use, offer for sale, sell, have sold, import, and export the Products in the Field (“WPRE Option”). The Licensee may exercise the WPRE Option by written notice to BioMedica. Upon exercise of the WPRE Option, the licence under the WPRE Patent shall be deemed part of the definition of “Licensed Patents”.
|
2.3
|
Retained Rights
|
(a)
|
to the extent necessary to give effect to and perform the obligations of BioMedica and its Affiliates under the agreement between L’Assistance Publique – Hopitaux de Paris, Le Commissariat a L’Energie Atomique et aux Energies Alternatives (CEA), and Oxford BioMedica (UK) Limited, dated 7 March 2017; and
|
(b)
|
to the extent necessary to perform its obligations under this Agreement and any other written agreement between the Parties.
|
2.4
|
Sublicensing
|
(a)
|
The Licensee may grant sublicenses through one or multiple tiers, under any or all of the rights granted in Clause 2.1 (Grant of License; Right of Reference), to its Affiliates and to Third Parties. The Licensee shall, and shall procure that each of its Affiliates and each Sublicensee shall, notify BioMedica of the identity of any Sublicensee in writing not more than [***] following the grant of rights under the BioMedica IP to such Sublicensee.
|
(b)
|
All sublicenses of the rights granted under this Agreement or any sublicense must be in writing and:
|
(i)
|
include legally binding provisions at least as stringent as those contained in this Clause 2.4 (Sublicensing) and Clause 12 (Confidentiality);
|
(ii)
|
oblige the Sublicensee to report in writing to the Licensee achievement of any milestone event referred to in Clause 8.2 (Development and Regulatory Milestone Payments);
|
(iii)
|
oblige the Sublicensee to keep, at its normal place of business, accurate and up-to-date records and books of account in sufficient detail for the determination of Net Sales by the Sublicensee (through multiple tiers). Such books and records shall be retained by the Sublicensee (through multiple tiers) for three (3) years from the date on which they are generated, and shall be maintained in accordance with applicable Accounting Standards;
|
(iv)
|
provide that such sublicense shall automatically terminate upon termination of this Agreement; provided that, if the Sublicensee is not in material breach of any of its obligations under such sublicense, at the written request of the Sublicensee to BioMedica made within [***] following the termination of this Agreement, BioMedica shall enter into a direct licence with the Sublicensee on substantially the same terms as this Agreement but limited to the scope granted by the Licensee (or Sublicensee) to the Sublicensee, provided that:
|
(A)
|
BioMedica shall not be required to undertake obligations in addition to those required by this Agreement;
|
(B)
|
the financial terms of such direct licence shall be replaced by the applicable financial terms provided under this Agreement; and
|
(C)
|
BioMedica receives, in relation to the Sublicensee, at least those rights that it received in relation to the Licensee under this Agreement.
|
(c)
|
The Licensee shall remain liable to BioMedica in respect of any acts or omissions of any Affiliate or Sublicensee (through multiple tiers) that would, if effected by the Licensee, constitute a breach of this Agreement.
|
2.5
|
Non-Compete
|
(a)
|
BioMedica and its Affiliates shall not, alone or in collaboration with any Third Party, clinically develop, seek Regulatory Approval for, manufacture (or have manufactured), use, sell (or have sold), market, promote, import, export or otherwise commercialise a BioMedica Competing Product during the Term.
|
(b)
|
Notwithstanding the restrictions set out in Clause 2.5(a) (Non-Compete):
|
(i)
|
in the event that BioMedica or any of its Affiliates (A) acquires, by way of acquisition of the rights in, or acquisition of Control of any Third Party having rights in; or (B) assigns this Agreement, and all of its rights and obligations under this Agreement to a Third Party which itself or one of whose Affiliates is clinically developing, seeking Regulatory Approval for, manufacturing (or having manufactured), using, selling (or having sold), marketing, promoting, importing, exporting or otherwise commercialising; a BioMedica Competing Product, BioMedica shall (or shall procure that its respective applicable Affiliate) divest the BioMedica Competing Product, or cease to develop, seek Regulatory Approval for, manufacture (or have manufactured), use, sell (or have sold), market, promote, import, export or otherwise commercialise the BioMedica Competing Product, as soon as reasonably practicable, and in any case within twelve (12) months, after the completion of the acquisition. “Divest” as used in this Clause 2.5(b) (Non-Compete) shall mean the sale or transfer or exclusive license of rights to the BioMedica Competing Product to a Third Party without receiving a continuing share of profit, royalty payment, or other economic interest in the success of such BioMedica Competing Product;
|
(ii)
|
in the event of a Change of Control of BioMedica:
|
(A)
|
if, at the time of completion of such Change of Control of BioMedica, the Third Party acquirer has rights in a BioMedica Competing Product, neither the Third Party acquirer nor any of its Affiliates existing immediately prior to such transaction will have any obligations under this Clause 2.5 (Non-Compete) with respect to such BioMedica Competing Product, provided that such Third Party acquirer shall not have access to, and shall not refer to, rely upon, or use in any manner, the BioMedica IP or any intellectual property or Confidential Information of the Licensee
|
(B)
|
such Third Party acquirer or any of its Affiliates (excluding BioMedica and its Affiliates immediately before such Change of Control of BioMedica) may commence development, manufacture, using, selling, marketing, promoting, importing, exporting, and otherwise commercialising any BioMedica Competing Product, provided that each entity that is responsible for such BioMedica Competing Product shall not have access to, and shall not refer to, rely upon, or use in any manner, the BioMedica IP or any intellectual property or Confidential Information of the Licensee for the continued conduct of such BioMedica Competing Product.
|
(c)
|
The Licensee and its Affiliates shall not, alone or in collaboration with any Third Party, clinically develop, seek Regulatory Approval for, manufacture (or have manufactured), use, sell (or have sold), market, promote, import, export or otherwise commercialise a Licensee Competing Product during the Term.
|
(d)
|
Notwithstanding the restrictions set out in Clause 2.5(c) (Non-Compete);
|
(i)
|
in the event that the Licensee or any of its Affiliates (A) acquires, by way of acquisition of the rights in or acquisition of Control of any Third Party having rights in; or (B) assigns this Agreement, and all of its rights and obligations under this Agreement to a Third Party which itself or one of whose Affiliates is clinically developing, seeking Regulatory Approval for, manufacturing (or having manufactured), using, selling (or having sold), marketing, promoting, importing, exporting or otherwise commercialising; a Licensee Competing Product, the Licensee shall (or shall procure that its respective applicable Affiliate) divest the Licensee Competing Product, or cease to develop, seek Regulatory Approval for, manufacture (or have manufactured), use, sell (or have sold), market, promote, import, export or otherwise commercialise the Licensee Competing Product, as soon as reasonably practicable, and in any case within twelve (12) months, after the completion of the acquisition. “Divest” as used in this Clause 2.5(d) (Non-Compete) shall mean the sale or transfer or exclusive license of rights to the Licensee Competing Product to a Third Party without receiving a continuing share of profit, royalty payment, or other economic interest in the success of such Licensee Competing Product;
|
(ii)
|
in the event of a Change of Control of the Licensee:
|
(A)
|
if, at the time of completion of such Change of Control of the Licensee, the Third Party acquirer has rights in a Licensee Competing Product, neither the Third Party acquirer nor any of its Affiliates existing immediately prior to such transaction will have any obligations under this Clause 2.5 (Non-Compete) with respect to such Licensee Competing Product, provided that such Third Party acquirer shall not have access to, and shall not refer to, rely upon, or use in any manner, the BioMedica IP;
|
(B)
|
such Third Party acquirer or any of its Affiliates (excluding the Licensee and its Affiliates immediately before such Change of Control of the Licensee) may commence development, manufacture, using, selling, marketing, promoting, importing, exporting, and otherwise commercialising any Licensee Competing Product provided each entity that is responsible for such Licensee Competing Product shall not have access to, and shall not refer to, rely upon, or use in any manner, the BioMedica IP.
|
(e)
|
Each of the Parties recognises that the restrictions contained in this Clause 2.5 (Non-Compete) are properly required for the adequate protection of the Parties’ rights hereunder, and agree that if any provision in this Clause 2.5 (Non- Compete) is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such restrictions shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable.
|
2.6
|
BioMedica Reserved Product
|
(a)
|
If BioMedica commences development of a BioMedica Reserved Product, BioMedica may not grant rights to any Third Party to develop or commercialise such BioMedica Reserved Product until it has followed the procedure set out in this Clause 2.6 (BioMedica Reserved Product).
|
(b)
|
BioMedica shall notify the Licensee in writing promptly after the earlier of the date on which BioMedica (i) initiates substantial discussions with, or receives a term sheet from, a Third Party regarding the grant of a licence to such Third Party in respect of the BioMedica Reserved Product; or (ii) obtains final results of the first clinical trial of such BioMedica Reserved Product. If subsequently requested in writing by the Licensee, BioMedica shall provide to the Licensee the full, then-existing pre-clinical and clinical data in relation to the BioMedica Reserved Product within the Control of BioMedica (the date of such provision being the “Start Date”), provided that such Know-How shall be kept confidential by the Licensee pursuant to Clause 12 (Confidentiality), used only to for the purpose of determining whether to enter into an agreement with BioMedica in relation to the BioMedica Reserved Product, and disclosed only to those employees of the Licensee and its Affiliates who need to know the same for such purpose.
|
(c)
|
Within [***] after the Start Date, the Licensee may notify BioMedica in writing that it wishes to negotiate in good faith a licence in respect of the BioMedica Reserved Product. If the Licensee issues such notice:
|
(i)
|
the Parties shall negotiate in good faith, during the period expiring [***] after the Licensee’s notice to BioMedica that it wishes to negotiate a licence in respect of the BioMedica Reserved Product (“Exclusivity Period”), the grant of such licence by BioMedica to the Licensee; and
|
(ii)
|
during the Exclusivity Period (or the end of such negotiations without entering into a definitive agreement, if earlier), BioMedica shall not grant to any Third Party any licence in respect of the BioMedica Reserved Product.
|
(d)
|
If the Parties do not enter into a definitive agreement for the BioMedica Reserved Product during the Exclusivity Period, then BioMedica shall not, within a period of twelve (12) months thereafter, grant to any Third Party a licence in respect of the BioMedica Reserved Product on terms which are materially more favourable to such Third Party than the terms offered to the Licensee when taking into account only (i) the scope and exclusivity of rights granted, and (ii) the monetary payments due to BioMedica or its Affiliates.
|
2.7
|
Compliance with Applicable Laws
|
(a)
|
shall comply with, and shall cause its and its Affiliates’ and Sublicensees’ employees and contractors to comply with, all Applicable Laws; and
|
(b)
|
shall not employ or use the services of any person that has been debarred for example as under clause 306(a) or 306(b) of the United States Federal Food, Drug, and Cosmetic Act, as amended. If either Party becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to such Party, including the Party itself or its Affiliates or Sublicensees, that directly or indirectly relate to activities contemplated by this Agreement, such Party shall immediately notify the other Party in writing and such Party shall cease employing, contracting with, or retaining any such person to perform any such services.
|
3.
|
MANAGEMENT
|
3.1
|
Clinical Project Team
|
(a)
|
Within [***] after the Effective Date, the Parties shall establish a Clinical Project Team (“Clinical Project Team”) with each Party designating and notifying the other Party of its initial members to serve on the Clinical Project Team.
|
(b)
|
The Clinical Project Team will remain in place until completion of the transfer of the Clinical Trials and, unless otherwise requested in writing by the Licensee for a reasonable extension period, will be disbanded at the end of such period.
|
(c)
|
The Clinical Project Team shall consist of personnel of BioMedica and the Licensee (or its Affiliate), in each case, with appropriate background and expertise to contribute to the Clinical Project Team. Each Party may change its members on the Clinical Project Team from time to time upon written notice to the other Party.
|
(d)
|
Either Party may, from time to time, invite additional representatives or consultants, who are not Clinical Project Team members but who have
|
(e)
|
The Licensee shall appoint one (1) of its members to chair Clinical Project Team meetings, ensure the orderly conduct of Clinical Project Team meetings, and ensure that written minutes of each Clinical Project Team meeting are taken and issued to each of the Parties.
|
(f)
|
The Clinical Project Team shall meet as often as required. Such meetings may be conducted by telephone, videoconference or in person as determined by the chairperson. Each Party may call for meetings of the Clinical Project Team with reasonable prior notice (it being agreed that at least [***] shall constitute reasonable notice), to discuss matters within the purview of the Clinical Project Team.
|
3.2
|
Role of Clinical Project Team
|
(a)
|
planning and overseeing the conduct of the Ongoing Clinical Trials until transfer and the transfer of the Ongoing Clinical Trials to the Licensee;
|
(b)
|
providing a forum for, and facilitation of, communications between the Parties with respect to the Clinical Trials;
|
(c)
|
providing a forum for updates regarding safety, regulatory and other similar information as required to be provided by BioMedica under this Agreement; and
|
(d)
|
agreeing, by consensus of both Parties, the period of time for which the Licensee shall utilise, pursuant to Clause 6.2 (Engagement of Experienced BioMedica Personnel), the services of the OXB Project Personnel.
|
3.3
|
Process Development Project Team
|
(a)
|
Within [***] after the Effective Date, the Parties shall establish a Process Development Project Team (“Process Development Project Team”) with each Party designating and notifying the other Party of its initial members to serve on the Process Development Project Team.
|
(b)
|
The Process Development Project Team will remain in place until completion of the last Work Package and, unless otherwise requested in writing by the Licensee for a reasonable extension period, will be disbanded at the end of such period.
|
(c)
|
The Process Development Project Team shall consist of personnel of BioMedica and the Licensee (or its Affiliate), in each case, with appropriate background and expertise to contribute to the Process Development Project Team. Each Party may change its members on the Process Development Project Team from time to time upon written notice to the other Party.
|
(d)
|
Either Party may, from time to time, invite additional representatives or consultants, who are not Process Development Project Team members but who have knowledge and experience necessary to assist the Process Development Project Team, to attend Process Development Project Team meetings, subject to (i) approval of the other Party (not to be unreasonably withheld, conditioned, or delayed) and (ii) such representatives and consultants being bound by confidentiality obligations at least as stringent as those in this Agreement.
|
(e)
|
The Licensee shall appoint one (1) of its members to chair Process Development Project Team meetings, ensure the orderly conduct of Process Development Project Team meetings, and ensure that written minutes of each Process Development Project Team meeting are taken and issued to each of the Parties.
|
(f)
|
The Process Development Project Team shall meet as often as required. Such meetings may be conducted by telephone, videoconference or in person as determined by the chairperson. Each Party may call for meetings of the Process Development Project Team with reasonable prior notice (it being agreed that at least [***] shall constitute reasonable notice), to discuss matters within the purview of the Process Development Project Team.
|
3.4
|
Role of Process Development Project Team
|
(a)
|
preparing descriptions of Work Packages, which must be reasonably, mutually agreed to in good faith in writing and executed by an authorised representative of each Party in order to become effective;
|
(b)
|
discussing amendments to Work Packages and making recommendations to authorised representatives of each Party regarding such amendments;
|
(c)
|
providing a forum for, and facilitation of, communications between the Parties with respect to the Work Packages and the results of Work Packages; and
|
(d)
|
discussing the Work Packages and overseeing and monitoring their performance.
|
3.5
|
Limits
|
3.6
|
Scientific Advisory Board
|
3.7
|
Costs of Governance
|
4.
|
TRANSITION AND REPORTING ACTIVITIES
|
4.1
|
Transfer of Know-How and Ongoing Clinical Trials
|
(a)
|
BioMedica shall transfer the Licensed Know-How (excluding the Licensed Know- How referred to in Clause 1.1(k)(iii) (BioMedica IP)) and the Ongoing Clinical Trials to the Licensee pursuant to this Clause 4.1 (Transfer of Know-How and Ongoing Clinical Trials).
|
(b)
|
The Parties acknowledge and agree that as of Effective Date, BioMedica is conducting the Prosavin Clinical Trial and preparing for the initiation of the OXB- 102 Clinical Trial (the “Ongoing Clinical Trials”), and has entered into various agreements with Third Parties in connection with the conduct of such Ongoing Clinical Trials.
|
(c)
|
Within [***] after the Effective Date, BioMedica shall make available for download by the Licensee all Licensed Know-How (excluding the Licensed Know-How referred to in Clause 1.1(k)(iii) (BioMedica IP)) which immediately before the Effective Date was made available to the Licensee to view in the electronic due diligence data room.
|
(d)
|
Without prejudice to Clause 4.1(c) (Transfer of Know-How and Ongoing Clinical Trials), BioMedica shall transfer all Licensed Know-How (excluding the Licensed Know-How referred to in Clause 1.1(k)(iii) (BioMedica IP)) and responsibility for the Ongoing Clinical Trials to the Licensee as soon as practicable after the Effective Date in accordance with this Clause 4.1 (Transfer of Know-How and Ongoing Clinical Trials), and in order to execute such transfer:
|
(i)
|
within [***] after the Effective Date, the Clinical Project Team shall prepare and submit to authorised representatives of the Parties for execution, a transfer plan and budget (“Transfer Plan”) regarding the activities to be performed by the Parties in connection with the transfer of such Licensed Know-How and all responsibility for all Ongoing Clinical Trials from BioMedica to the Licensee;
|
(ii)
|
such Transfer Plan shall include the responsibilities of each of the Parties in relation to:
|
(A)
|
transfer of all pre-clinical and clinical data Controlled by BioMedica that was generated in the course of the Ongoing Clinical Trials relating specifically to the Products in the Field and that is necessary or
|
(B)
|
transfer of the applicable INDs for such Ongoing Clinical Trials from BioMedica to the Licensee;
|
(C)
|
transfer or assignment, as applicable and to the extent possible, of BioMedica’s rights and obligations under contracts with Third Parties relating to the Ongoing Clinical Trials;
|
(D)
|
transfer of all Regulatory Filings that are necessary to conduct the Ongoing Clinical Trials;
|
(E)
|
transfer physical possession of the Existing Inventory to, at the Licensee’s discretion, either (1) the Licensee, (2) the site of an Ongoing Clinical Trial, or (3) any contractor of the Licensee; and
|
(F)
|
transfer or assignment, as applicable and to the extent possible, of BioMedica’s rights and obligations under contracts with Third Parties relating to the Existing Inventory; and
|
(iii)
|
following execution of such Transfer Plan by authorised representatives of the Parties, each of the Parties shall perform their obligations under such Plan to expeditiously transfer of all responsibility for all Ongoing Clinical Trials from BioMedica to the Licensee, and BioMedica shall provide the Licensee with reasonable access during normal business hours (upon reasonable advance notice), to BioMedica personnel either in-person at BioMedica’s facility or by teleconference as required for the performance of such activities by BioMedica.
|
(e)
|
With effect from the date on which all responsibility for an Ongoing Clinical Trial is transferred from BioMedica to the Licensee, all legal and regulatory responsibility for such Ongoing Clinical Trial shall transfer to the Licensee.
|
(f)
|
The Licensee shall reimburse BioMedica for reasonable time spent by BioMedica in connection with preparation and performance by BioMedica of the Transfer Plan at the FTE Rate (except to the extent that such obligations are performed by the OXB Project Personnel pursuant to Clause 6.2 (Engagement of Experienced BioMedica Personnel), in which case the time spent by such OXB Project Personnel shall be paid for by the Licensee in accordance with Clause 6.2 (Engagement of Experienced BioMedica Personnel)). BioMedica shall provide reasonably detailed invoices to the Licensee for such time spent by BioMedica, and the Licensee shall pay the undisputed amount invoiced within [***] after the date of any such invoice.
|
(g)
|
The Licensee shall reimburse BioMedica, within [***] after issue of a reasonably detailed invoice by BioMedica to the Licensee, for amounts that BioMedica reasonably incurs after the Effective Date with respect to the Ongoing Clinical Trials.
|
4.2
|
Safety Data Exchange
|
4.3
|
Interim Performance of Ongoing Clinical Trials
|
(a)
|
Notwithstanding Clause 6.1 (Development) and Clause 6.3 (Regulatory), until completion of the transfer of the Ongoing Clinical Trials in accordance with Clause 4.1 (Transfer of Know-How and Ongoing Clinical Trials), BioMedica shall:
|
(i)
|
be the sponsor of the Ongoing Clinical Trials and shall conduct the Ongoing Clinical Trials in accordance with the applicable clinical trial protocols. BioMedica shall consult with the Licensee in relation to all aspects of the conduct of the Ongoing Clinical Trial and shall implement all decisions and directions of the Licensee which are consistent with the protocols and Applicable Law, provided that BioMedica shall be entitled to take any steps it deems necessary in connection with patient safety in connection with the Ongoing Clinical Trials;
|
(ii)
|
remain the primary contact for Regulatory Authorities with respect to the Ongoing Clinical Trials;
|
(iii)
|
keep the Licensee reasonably informed as to any interactions with any Regulatory Authorities relating to the Ongoing Clinical Trials, shall provide any Regulatory Filings and material correspondence with any Regulatory Authorities relating to the Ongoing Clinical Trials to the Licensee for the Licensee’s review and comment; and
|
(iv)
|
remain responsible for all safety reporting obligations to the Regulatory Authorities with respect to the Ongoing Clinical Trials; provided that, BioMedica shall keep the Licensee reasonably informed as to any such matters reported.
|
(b)
|
BioMedica shall issue invoices to the Licensee in respect of the following costs and expenses incurred by BioMedica in connection with BioMedica’s interim conduct of the Ongoing Clinical Trials and transfer of the Ongoing Clinical Trials to the Licensee, in each case after the Effective Date:
|
(i)
|
except to the extent that such obligations are performed by the OXB Project Personnel pursuant to Clause 6.2 (Engagement of Experienced BioMedica Personnel), fees for the time spent by BioMedica after the Effective Date in connection with conduct of the Ongoing Clinical Trials at the FTE Rate;
|
(ii)
|
all reasonable, out-of-pocket expenses incurred by BioMedica after the Effective Date in connection with conduct of the Ongoing Clinical Trials provided that, BioMedica shall include adequate supporting documentation for such expenses together with any invoices; and
|
(iii)
|
the reasonable cost of all devices, consumables and the like used in connection with performance of the Ongoing Clinical Trials after the Effective Date; and
|
5.
|
BIOMEDICA PROCESS DEVELOPMENT
|
5.1
|
Process Development Services
|
(a)
|
Promptly after the Effective Date the Process Development Project Team shall prepare, and submit to authorised representatives of the Parties for execution, one or more Work Packages pursuant to which BioMedica shall conduct process development activities in relation to the Manufacture of the Products (the “Process Development Services”). Each Work Package shall:
|
(i)
|
become binding only once it is recorded in writing and is signed by authorised representatives of both Parties;
|
(ii)
|
set out a fixed price for the performance by BioMedica of the activities described and results required (as applicable) under such Work Package to the extent relating to the development of a serum-free suspension process;
|
(iii)
|
set out reasonable estimates on the basis of time (at the FTE Rate) and materials for the performance by BioMedica of additional activities described (other than the development of a serum-free suspension process) and results required (as applicable) under such Work Package(s);
|
(iv)
|
describe the items to be provided by BioMedica to the Licensee under such Work Package(s), including items specifically designated or characterized as deliverables in a Work Package.
|
(b)
|
In the event of any conflict between this Agreement and a Work Package, this Agreement shall control unless the Work Package expressly refers to the Parties’ intent to alter the terms of this Agreement with respect to that Work Package.
|
(c)
|
Upon the receipt of a proposal from the Licensee to change the terms of a Work Package (a “Change Proposal”), the Parties shall discuss such Change Proposal in good faith. Changes to a Work Package will not be effective unless mutually agreed in writing by the Parties.
|
5.2
|
Performance of Work Packages
|
(a)
|
BioMedica shall perform the activities set out in the Work Packages in accordance with the provisions of such Work Package, this Agreement, and all Applicable Laws.
|
(b)
|
BioMedica shall perform such activities in a professional manner, in conformance with that level of care and skill ordinarily exercised by other professionals in the biopharmaceutical industry in similar circumstances.
|
(c)
|
The Licensee shall promptly provide to BioMedica all materials, information, advice, approvals and other assistance reasonably required by BioMedica in connection with its performance of the Work Packages. BioMedica shall not be liable for any breach of this Agreement arising from any delay or failure of the Licensee to provide the same.
|
(d)
|
BioMedica may subcontract the performance of its obligations under the Work Packages to any Affiliate or Third Party provided that BioMedica remains responsible for (i) the work allocated to such subcontractors to the same extent it would if it had done such work itself, (ii) monitoring the performance of such subcontractors and (iii) any action or inaction by any such subcontractor that if taken or not taken by BioMedica would constitute a breach of this Agreement.
|
(e)
|
BioMedica shall use reasonable efforts to comply with any timelines, milestones, schedules, or target dates for completing the services or any portion thereof as set forth in a Work Package; provided that the Parties acknowledge that unless specified in a Work Package, the nature of the work to be conducted under the Work Packages(s) is of an experimental nature and as such, any timelines set out in any Work Package are good faith estimates only; provided further that BioMedica recognizes the importance of the Process Development Services to the Licensee and agrees to allocate to the performance of such services an equivalent level of prioritization as it allocates to similar activities BioMedica performs for Third Parties. BioMedica shall promptly inform the Process Development Project Team upon becoming aware of any unforeseen results, problems, difficulties, delays, or the like with regard to the activities under the Work Packages and the estimated duration of any delay.
|
5.3
|
Record Keeping and Reporting
|
(a)
|
BioMedica shall create and maintain written records of the data and other information generated or recorded in the performance of the Process Development Services (the “Records”) in sufficient detail and in a good scientific manner, including all Process Development Results. During the course of conducting the Process Development Services, BioMedica shall, at the Licensee’s request and expense, provide the Licensee with copies of the Records.
|
(b)
|
BioMedica shall provide updates on the status and results of the Work Packages to the Process Development Project Team and shall provide reports outlining the progress of the Process Development Services in accordance with the applicable Work Package.
|
5.4
|
Process Development Results
|
(a)
|
Notwithstanding Clause 11.1 (Ownership), the Licensee owns all right, title and interest in and to the Process Development Results that solely and specifically relate to a Product such that they cannot reasonably be used in connection with the manufacture of any other product (the “Product-Specific Process Development Results”). BioMedica
|
(b)
|
Notwithstanding Clause 11.1 (Ownership), BioMedica owns all right, title and interest in and to the Process Development Results that are not Product-Specific Process Development Results (the “General Process Development Results”). BioMedica hereby grants to the Licensee a non-exclusive, perpetual, irrevocable, worldwide, royalty-free, sublicenseable (through one or multiple tiers) license under all General Process Development Results to research, develop, Manufacture and have Manufactured (subject to Clause 7 (Manufacture) with respect to Manufacture of Products), use, offer for sale, sell, have sold, import, and export (i) the Products in the Field and (ii) any other products that BioMedica manufactures for the Licensee or its Affiliates, including pursuant to separate agreements.
|
5.5
|
Process Development Services Costs
|
(a)
|
Subject to the terms and conditions of this Agreement, the Licensee shall pay BioMedica the fees specified in each Work Package (“Fees”) as BioMedica’s sole and complete compensation for all Process Development Services and Process Development Results.
|
(b)
|
BioMedica shall issue invoices to the Licensee in respect of the Fees associated with each Work Package in accordance with the terms of each Work Package. BioMedica may not submit for payment any invoice for services that the Licensee has not consented to pursuant to an executed Work Package or Change Proposal.
|
(c)
|
Except as otherwise stated in the Work Package and subject to Clause 9.3 (Payment), such invoices shall be exclusive of VAT or other applicable taxes and the Licensee shall pay such invoices within [***] after receipt of such invoice.
|
(d)
|
Notwithstanding the foregoing, the Licensee is entitled to, and BioMedica shall issue to the Licensee, a credit in the amount of [***] (being a portion of the upfront payment received by BioMedica), such credit to be applied to (i) amounts that would otherwise have become due in accordance with the Work Packages (and representing the reimbursement of BioMedica’s costs of salaries, equipment and overheads in providing the Process Development Services) and (ii) the cost of procuring at least one (or more if such credit has not been fully used) clinical batches of Product that is Manufactured using the manufacturing process developed pursuant to such Work Packages, excluding the cost of Plasmids. BioMedica shall include on each invoice raised with respect to such amounts the amount of the credit used, the total amount of such credit remaining and a description of the work actually performed in sufficient detail to permit reasonable
|
6.
|
DEVELOPMENT, REGULATORY, AND COMMERCIALISATION
|
6.1
|
Development
|
(a)
|
Following completion of the transfer of the Ongoing Clinical Trials pursuant to Clause 4.1 (Transfer of Know-How and Ongoing Clinical Trials), the Licensee shall have sole discretion (subject to the provisions of this Agreement including Clause 6.2 (Engagement of Experienced BioMedica Personnel)), control and responsibility, at the Licensee’s sole cost, to conduct development of Products (including all clinical trials, formulation studies, and regulatory activities) that is necessary for or otherwise supports obtaining and maintaining Regulatory Approval for Products in the Field.
|
(b)
|
The Licensee may perform its development activities under this Agreement through one or more subcontractors, provided that the Licensee remains responsible for (i) the work allocated to such subcontractors to the same extent it would if it had done such work itself, (ii) monitoring the performance of such subcontractors and (iii) any action or inaction by any such subcontractor that if taken or not taken by the Licensee would constitute a breach of this Agreement.
|
(c)
|
As soon as practicable and no later than [***] after the Effective Date, the Licensee shall provide to BioMedica an initial plan in reasonable detail of any development activities and regulatory strategy anticipated to be conducted to obtain Regulatory Approval and Pricing and Reimbursement Approval (as applicable) of the Product in each Major Market, including good faith estimates of dates for reaching each Development Milestone and Regulatory Milestone as set out in Clause 8.2 (Development and Regulatory Milestone Payments). Promptly after the expiry of each six (6) month period thereafter, the Licensee shall provide to BioMedica an update of such development plan, including an update of the good faith estimates of dates for reaching each remaining Development Milestone and Regulatory Milestone as set out in Clause 8.2 (Development and Regulatory Milestone Payments), together with a summary in reasonable detail of all development activities conducted by the Licensee in the preceding [***] including, as applicable, the status of any Clinical Trials of the Product. The Parties acknowledge that such statements shall be used by BioMedica in the assessment of the performance by the Licensee of its diligence obligations under this Agreement and may be disclosed by BioMedica to any Third Party to whom BioMedica has reporting obligations with respect to the Product, in each case under written obligations of confidentiality and non- use at least as stringent as those herein.
|
6.2
|
Engagement of Experienced BioMedica Personnel
|
(a)
|
With effect from the Effective Date, the Licensee shall, in connection with (i) the conduct of the Transfer Plan, and (ii) performance of the Ongoing Clinical Trials, use reasonable efforts to utilise the services of up to six (6) FTEs that are engaged by BioMedica at the time of such performance as employees, consultants, or contractors (“OXB Project Personnel”) for the longer of (A) one
|
(b)
|
BioMedica shall issue invoices to the Licensee in respect of fees for the time spent by the OXB Project Personnel in connection with the conduct of the Transfer Plan, and performance of the Ongoing Clinical Trials at the FTE Rate, provided that in the event that the Licensee does not utilise the full time commitment of the relevant individuals as set out in
Schedule 2
for each year of the period of time described in Clause 6.2(a) (Engagement of Experienced BioMedica Personnel), then so long as such individuals are able and willing to serve as OXB Project Personnel and meeting the Licensee’s reasonable performance standards, then BioMedica shall be entitled to invoice for the full time commitment so specified. The Licensee shall pay such invoices within [***] after receipt of the same.
|
(c)
|
In order to protect the legitimate business interests of BioMedica, the Licensee shall not (and shall procure that its Affiliates do not) during the term of the Ongoing Clinical Trials and for a period of [***] following completion of the transfer of the Ongoing Clinical Trials (i) attempt to solicit or entice away, or (ii) solicit or entice away, from the employment or service of BioMedica, any OXB Project Personnel other than by means of a public advertising campaign not specifically targeted at such individuals; provided that, it is understood and agreed that an offer of employment to any OXB Project Personnel that results from an unsolicited inquiry by such person will not be deemed to be a violation of this provision.
|
6.3
|
Regulatory
|
6.4
|
Commercialization
|
(a)
|
Subject to the terms and conditions of this Agreement, the Licensee has the sole and exclusive control over all matters relating to the commercialization of Products in the Field. Without limiting the foregoing, the Licensee has the sole and exclusive right and control for the following with respect to Products in the Field: (a) developing and executing a commercial launch and pre-launch plan,
|
6.5
|
Diligence
|
(a)
|
develop and seek Regulatory Approval and Pricing and Reimbursement Approval (to the extent applicable) for at least one Product in (i) the United States and (ii) at least one of the United Kingdom, Germany, France, Spain and Italy; and
|
(b)
|
commercialise each Product in each country for which the Licensee obtains Regulatory Approval.
|
6.6
|
Diligence Milestones
|
(a)
|
[***];
|
(b)
|
[***]; and
|
(c)
|
[***];
|
6.7
|
Failure to Meet Diligence Milestones
|
(a)
|
in the event that the Diligence Milestone set forth in Clause 6.6(a) (Diligence Milestones) is not achieved: [***] upon the first anniversary of the Effective Date and each anniversary of the Effective Date thereafter until such time as such Diligence Milestone is met;
|
(b)
|
in the event that the Diligence Milestone set forth in Clause 6.6(b) (Diligence Milestones) is not achieved: [***] upon the second anniversary of the Effective Date and each anniversary of the Effective Date thereafter until such time as such Diligence Milestone is met; and
|
(c)
|
in the event that the Diligence Milestone set forth in Clause 6.6(c) (Diligence Milestones) is not achieved: [***], provided that it is understood and agreed that [***];
|
6.8
|
Trademarks
|
7.
|
MANUFACTURE
|
7.1
|
Manufacture and Supply of Product
|
(a)
|
BioMedica shall Manufacture the Products for use by the Licensee in the development and commercialization of the Products, subject to and in accordance with the terms of this Agreement and subject to and in accordance with the separate clinical and commercial supply agreements to be negotiated by the Parties as set forth below.
|
(b)
|
Within [***] after the Effective Date, the Parties shall negotiate in good faith a clinical supply agreement governing supply of Product by BioMedica for clinical use in accordance with the terms of
Schedule 7 – Part 1
. Such clinical supply agreement (the “Clinical Supply Agreement”) shall have the terms set forth on
Schedule 7 – Part 1
and such other terms and conditions customary for a clinical supply agreement. Upon request by the Licensee, the Parties shall negotiate in good faith a commercial manufacturing and supply agreement (the “Commercial Supply Agreement”) on commercially reasonable terms, including the terms set forth on
Schedule 7 – Part 2
.
|
7.2
|
Existing Inventory
|
(a)
|
The Parties acknowledge that BioMedica holds batches of Product as of the Effective Date as described in
Schedule 6
(the “Existing Inventory”). The Parties acknowledge that as at the Effective Date, the Existing Inventory has not been released by the BioMedica Qualified Person for use in Clinical Trials. BioMedica shall take all commercially reasonable steps to procure the testing, fill, finish and release by the BioMedica Qualified Person of all Existing Inventory, provided that the Parties acknowledge that it cannot be determined at the Effective Date whether or not the Existing Inventory will be released by the BioMedica Qualified Person for use in Clinical Trials. If any of the Existing Inventory is not released by the BioMedica Qualified Person for use in Clinical Trials or does not meet specifications that would enable use in Clinical Trials, then BioMedica shall replace such Existing Inventory with Product that is released by the BioMedica
|
(b)
|
The Parties agree that:
|
(i)
|
to the extent that the Existing Inventory is in the possession of BioMedica or its contractors, BioMedica shall store such Existing Inventory in accordance with its current procedures and use commercially reasonable efforts to preserve the integrity of the Existing Inventory pending physical transfer in accordance with the Transfer Plan provided that in the event of any loss or damage to such Existing Inventory after the date of release of the same by the BioMedica Qualified Person for use in Clinical Trials, BioMedica shall not have any liability to the Licensee for such loss;
|
(ii)
|
BioMedica shall keep the Licensee regularly informed, through the Clinical Project Team or otherwise, regarding developments in connection with the release by the BioMedica Qualified Person of the Existing Inventory for use in Clinical Trials and the anticipated date of such release, and shall take reasonable steps at the request and expense of the Licensee to assist and facilitate the Licensee to enter into appropriate agreements with the Third Party contractors identified in
Schedule 6
; and
|
(iii)
|
title to and risk of loss in the Existing Inventory shall pass to the Licensee, without cost or charge to the Licensee, when the Existing Inventory is released by the BioMedica Qualified Person for use in Clinical Trials.
|
(c)
|
With respect to Existing Inventory, as at the date on which such Existing Inventory is released by the BioMedica Qualified Person for use in the Ongoing Clinical Trials, BioMedica warrants that such Existing Inventory has been manufactured:
|
(i)
|
in accordance with the specifications that have been provided by BioMedica to the Licensee in the electronic due diligence data room as of the Effective Date, which such specifications are hereby incorporated by reference into this Agreement; and
|
(ii)
|
in accordance with Good Manufacturing Practice as defined in European legislation.
|
7.3
|
Technology Transfer
|
(a)
|
At any time following the completion of formal process characterization studies that enable process definition, process validation or BLA submission in respect of a Product, the Licensee may request that BioMedica perform a one-time-only complete technology transfer sufficient for the Manufacture of the Products by the Licensee, its Affiliate or
|
(i)
|
in the event that BioMedica has or will contract with Third Parties with respect to the Manufacture of Product, BioMedica will, upon Licensee’s request, grant to the Licensee reasonable access and permission to engage in substantive discussions with such Third Parties and reasonably assist the Licensee in such discussions, and will execute, acknowledge, and deliver such further instruments, and do all further similar acts, as may be necessary or appropriate to carry out the purposes and intent of such technology transfer;
|
(ii)
|
such technology transfer shall be completed as promptly as possible and in accordance with generally accepted industry technology transfer standards; and
|
(iii)
|
such transfer budget shall provide for the Licensee to pay to BioMedica the then current BioMedica FTE rate for time spent in connection with preparation and performance of the technology transfer plan, together with pre-approved travel and subsistence costs incurred by BioMedica personnel in connection with these activities. The Licensee shall reimburse BioMedica, within [***] after issue of invoices raised by BioMedica, for such time spent by BioMedica pursuant to such transfer plan and budget.
|
(b)
|
Notwithstanding Clause 7.3(a) (Technology Transfer), BioMedica shall not be obliged to transfer the Licensed Know-How relating to Manufacture of Products to an Affiliate of the Licensee or a Third Party (and the Licensee may not transfer the Licensed Know-How relating to Manufacture of Products to an Affiliate of the Licensee or a Third Party) unless:
|
(i)
|
such Affiliate, Sublicensee or contractor has entered into a legally binding confidentiality agreement with BioMedica on terms at least as stringent as the terms set forth herein; and
|
(ii)
|
such Affiliate or Third Party is prohibited from further sublicensing or transferring any part of the process to Manufacture of the Product, unless such sublicensing or transferring is to qualify a second supplier to Manufacture the Product; provided that it is understood and agreed that only one (1) Affiliate or Third Party is permitted to be qualified as a second supplier at any time.
|
(c)
|
In connection with a transfer of the Licensed Know-How relating to Manufacture of Products to a second supplier pursuant to Clause 7.3(b) (Technology Transfer), BioMedica shall use good faith efforts to make BioMedica personnel available on a reasonable basis to support and consult with Licensee, an Affiliate, or a Third Party, as applicable, but shall have no obligation to effect such a transfer. Licensee hereby acknowledges that, over time, BioMedica resources with the relevant knowledge to provide such support and consultation will diminish. Licensee will reimburse BioMedica within [***] after issuance of invoices by BioMedica for its reasonable and documented costs in connection with such support and consultation.
|
8.
|
MONETARY OBLIGATIONS
|
8.1
|
License Fee
|
8.2
|
Development and Regulatory Milestone Payments
|
8.3
|
Commercial Milestone Payments
|
Annual Net Sales Milestone
|
Milestone Payment
|
Annual Net Sales of [***] or more
|
$[***]
|
Annual Net Sales of [***]or more
|
$[***]
|
Annual Net Sales of [***]or more
|
$[***]
|
8.4
|
Royalties
|
(a)
|
The Licensee shall pay BioMedica royalties as set forth below on Annual Net Sales in respect of all Product sold during the Royalty Term, as calculated by multiplying the applicable royalty rate set forth below by the corresponding amount of Annual Net Sales in such Fiscal Year:
|
(i)
|
[***] on that portion of Annual Net Sales that is less than [***];
|
(ii)
|
[***] on that portion of Annual Net Sales that is equal to or greater than [***] but less than [***];
|
(iii)
|
[***] on that portion of Annual Net Sales that is equal to or greater than [***] but less than [***]; and
|
(iv)
|
[***] on that portion of Annual Net Sales of Product that is equal to or greater than [***].
|
(b)
|
If, at any time during the Royalty Term for a Product in a country for which there is no Valid Claim that Covers such Product in such country, one or more Third Parties who are not Sublicensees sell in such country an Alternative Product to such Product and such
|
(c)
|
The Licensee may deduct from any royalty payments to BioMedica under Clause 8.4(a) (Royalties) in respect of a given Fiscal Quarter [***] of any licensee fees, milestone payments, and royalties paid by the Licensee to a Third Party during such Fiscal Quarter or the immediately preceding Fiscal Quarter in consideration for a license under such Third Party’s Patents or Know- How that are necessary for (i) sale of an Original Product or (ii) Manufacture of an Original Product using the unmodified and unenhanced manufacturing process transferred by BioMedica pursuant to Clause 7.3 (Technology Transfer).
|
(d)
|
In no circumstances will the royalties payable to BioMedica pursuant to this Clause 8.4 (Royalties) in respect of any Fiscal Quarter be reduced, as a result of Clauses 8.4(b) (Royalties) or 8.4(c) (Royalties), below [***] of the royalties otherwise payable under this Clause 8.4 (Royalties).
|
8.5
|
Net Receipts
|
8.6
|
Paediatric Priority Review Voucher
|
8.7
|
Third Party Payments
|
9.
|
INVOICES, PAYMENTS AND REPORTS
|
9.1
|
Invoices and Estimates
|
(a)
|
Within [***] after the end of each month during the Term, BioMedica shall provide the Licensee with a good faith estimate of the amount for which it anticipates that it will invoice the Licensee for any amounts for which BioMedica is required to invoice the Licensee under this Agreement in such month.
|
(b)
|
BioMedica shall include a reasonably detailed description of the work performed or other basis for any amount for which it issues an invoice to the Licensee under this Agreement.
|
9.2
|
Milestone Payments
|
9.3
|
Royalty Reports
|
(a)
|
Not later than (i) [***] following the end of each Fiscal Quarter (excluding the last Fiscal Quarter of a Fiscal Year and the Fiscal Quarter in which the expiry or termination of this Agreement takes effect) or (ii) [***] after the end of the last Fiscal Quarter of a Fiscal Year and the Fiscal Quarter in which the expiry or termination of this Agreement takes effect, the Licensee shall submit to BioMedica a written report (“Royalty Report”) detailing:
|
(i)
|
on a country-by-country basis:
|
(A)
|
the quantity of Product sold by each Selling Entity; and
|
(B)
|
the Net Sales of Products during such Fiscal Quarter by each Selling Entity in GBP and the currency in which the Net Sales were recorded showing the conversion rates used; and
|
(ii)
|
the Net Receipts received or obtained in such Fiscal Quarter and the Sublicensee to which they relate.
|
(b)
|
Following receipt of the Royalty Report, BioMedica shall issue an invoice to the Licensee for the royalties due under this Agreement for the reported Fiscal Quarter. The Licensee shall pay such invoice within [***] after receipt of such invoice; provided, that the Licensee shall pay such invoice within [***] after receipt of any invoice issued based on the Royalty Report for the last Fiscal Quarter of a Fiscal Year.
|
9.4
|
Payment
|
(a)
|
All sums due to BioMedica under this Agreement:
|
(i)
|
are exclusive of Value Added Tax, which where applicable will be paid by the Licensee in addition. BioMedica shall provide to the Licensee all customary receipts for payment of such taxes and cooperate with the Licensee in making applications for and securing any available exemptions or reductions of VAT reasonably available; notwithstanding the foregoing, the Parties acknowledge and agree that (1) on the basis of Applicable Law in force as at the date of this Agreement and subject to any changes in relevant circumstances of the Licensee or any Affiliate during the term of this Agreement, there is no current expectation that BioMedica will be required to charge Value Added Tax with respect to the transactions under this Agreement; and (2) each Party will not take any position or otherwise take any action that is inconsistent with the position that, for United Kingdom Tax purposes, Value Added Tax is inapplicable to the transactions under this Agreement, unless there is a relevant change in Applicable Law or relevant change in circumstances of the Licensee or any Affiliate, or unless otherwise required by a final determination of a court of competent jurisdiction;
|
(ii)
|
shall be paid in GBP, in cash by transferring an amount in aggregate to the following account:
|
(b)
|
When conversion of payments from any foreign currency is required, the Licensee shall convert such amounts into GBP using the average exchange rate applicable at the invoice date using the OANDA forex currency converter, or other reputable currency converter agreed between the Parties from time to time.
|
(c)
|
If laws or regulations require withholding by the Licensee of any Taxes imposed upon BioMedica on account of any royalties and payments paid under this Agreement, such Taxes shall be deducted by the Licensee as required by law from such remittable royalty and payment and shall be paid by the Licensee to the proper tax authorities. To the extent that amounts are so withheld and paid to the proper taxing authority, such amounts shall be treated for all purposes of this Agreement as having been paid to BioMedica. Official receipts of payment of any withholding Tax shall be secured and sent to BioMedica as evidence of such payment. The parties shall cooperate to ensure that any withholding Taxes imposed are reduced as far as possible under Applicable Law (including any relevant Tax treaty), which shall include providing assistance with the completion of any required forms. In addition, the Parties shall cooperate in accordance with Applicable Law to minimize indirect Taxes (such as Value Added Tax, transfer Tax, sales Tax, consumption Tax and other similar Taxes) in connection with this Agreement, provided that where any such Taxes are Taxes that are or may be imposed outside the United Kingdom, the Licensee shall indemnify BioMedica to its reasonable satisfaction against any material and reasonable out of pocket costs and expenses in taking any action in cooperation requested by the Licensee.
|
(d)
|
If any undisputed payment due is not paid by the due date, BioMedica may charge interest on any outstanding amount of such payment on a daily basis at the lower of (i) the maximum rate permitted under Applicable Law and (ii) a rate equivalent to [***] per annum above the base rate of the Bank of England then in force in London.
|
(e)
|
Notwithstanding anything else in this Section 9.4, each Party shall be solely responsible for the payment of all Taxes imposed on its share of income (however denominated) or gain arising directly or indirectly from the activities of the Parties under this Agreement, except to the extent any such Taxes are deducted or withheld and taken into account pursuant to the definition of “Net Receipts”.
|
10.
|
RECORDS AND AUDIT
|
10.1
|
Records
|
10.2
|
Audit
|
(a)
|
At the request and expense (except as provided below) of a Party wishing to conduct an audit (the “Auditing Party”) of the other Party’s records and books (the “Other Party”), the Other Party and its Affiliates shall permit an independent, certified public accountant appointed by the Auditing Party and reasonably acceptable to the Other Party, during normal business hours and upon reasonable prior written notice to the Other Party, once per Fiscal Year, to examine (i) in the case of an audit by BioMedica of the Licensee or its Affiliates, those records and all other material documents of the Licensee or its Affiliates relating to or relevant to calculation of the amounts due to BioMedica hereunder; and (ii) in the case of an audit by the Licensee of BioMedica or its Affiliates, those timesheets and records of pass-through costs in relation to the Process Development Services, transfer of the Licensed Know-How, Ongoing Clinical Trials, and technology transfer; in each case in respect of any period within three (3) years following the Fiscal Year (in the case of the Licensee) or Calendar Year (in the case of BioMedica) to which such records or documents pertain. The results of any such examination shall be made available to both Parties. In the event of an audit of BioMedica, the amounts incurred by BioMedica or its Affiliates shall be reconciled if a disparity is determined. If, as a result of any such examination of the Licensee or its Affiliates, it is the opinion of the accountant that the amounts paid to BioMedica were more or less than the amount which should have been paid, then the Licensee shall make all payments required to eliminate any such discrepancy within [***] after BioMedica’s written demand therefor, and BioMedica shall credit any excess amounts paid against future payments due from the Licensee (and if no further payments are due, shall be refunded by BioMedica at the request of the
|
(b)
|
At the request and expense (except as provided below) of BioMedica, the Licensee shall perform an audit, through an independent, certified public accountant appointed by BioMedica and reasonably acceptable to the Licensee, of those records and all other material documents of any Sublicensee relating to or relevant to calculation of the amounts due to BioMedica hereunder in respect of any period within three (3) years after the date to which such records or documents relate. The results of any such examination shall be made available to both Parties. If, as a result of any such examination, it is the opinion of the accountant that the amounts paid to BioMedica were (i) less than the amount which should have been paid, then the Licensee shall make all payments required to eliminate any such discrepancy within [***] after BioMedica’s demand therefor, or (ii) more than the amount which should have been paid, then such additional amounts shall be credited against future payments until such discrepancy is eliminated. In addition, if such underpaid amount is in excess of [***] of the amount that actually should have been paid by the Licensee, then the Licensee shall reimburse BioMedica for the reasonable cost of such audit.
|
11.
|
INTELLECTUAL PROPERTY
|
11.1
|
Ownership
|
(a)
|
In respect of any Inventions, inventorship as between the Parties will be determined in accordance with the rules of inventorship of the jurisdiction in which such Inventions were invented. Each Party solely owns any Inventions made solely by its own employees, agents, or independent contractors, together with all intellectual property rights therein. The Parties jointly own any Inventions that are made jointly by employees, agents, or independent contractors of each Party, together with all intellectual property rights therein (“Joint Inventions”). All Patents claiming Joint Inventions will be referred to as “Joint Patents”.
|
(b)
|
Each Party may practice and exploit the Joint Inventions and Joint Patents without the duty of accounting or seeking consent from the other Party and, subject to the terms of this Agreement, including Clause 2.5 (Non-Compete), each Party hereby grants to the other a non-exclusive, worldwide, fully paid up, perpetual, irrevocable, sublicensable (through multiple tiers), transferable licence under such Joint Inventions and Joint Patents. Each Party shall use reasonable efforts to promptly disclose to the other Party all Joint Inventions, including any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing inventions that are Joint Inventions, and all information relating to such Joint Inventions to the extent necessary or useful for the preparation, filing and maintenance of any Patent with respect to such Joint Invention.
|
(c)
|
For clarity, Process Development Results are excluded from the definition of Inventions and the provisions of this Clause 11 (Ownership), and ownership of such Process Development Results are addressed in Clause 5.4 (Process Development Results).
|
(d)
|
To the extent applicable, each Party shall cause all employees, independent contractors, consultants and others who perform activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such person or entity to agree to such assignment obligation despite such Party using reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in and to any Inventions and all intellectual property rights therein to such Party, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions which have standard policies against such an assignment (in which case a Party shall obtain a suitable license, or right to obtain such a license).
|
(e)
|
Each Party shall cooperate fully with the other Party in the preparation, filing, prosecution and maintenance of Licensed Patents and Joint Patents under Clause 11.2 (Filing, prosecution and maintenance of Joint Patents) and Clause 11.3 (Filing, prosecution and maintenance of Licensed Patents), respectively. Such cooperation includes (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as enable the other Party to apply for and to prosecute patent applications in any country as permitted by Clause 11.2 (Filing, prosecution and maintenance of Joint Patents) and Clause 11.3 (Filing, prosecution and maintenance of Licensed Patents), and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may affect the preparation, filing, prosecution or maintenance of any such patent applications.
|
11.2
|
Filing, prosecution and maintenance of Joint Patents
|
(a)
|
Subject to Clause 11.2(b) (Filing, prosecution and maintenance of Joint Patents), as between the Parties, the Licensee has the first right, but not the obligation, to prepare, file, prosecute, maintain and defend the Joint Patents at the Licensee’s cost and expense. The Licensee shall consult with BioMedica with respect to the filing and prosecution of the Joint Patents. The Licensee shall provide BioMedica with drafts of any proposed filings to allow BioMedica to review and comment before such filings are due. BioMedica may provide comments on such of those documents to be submitted to any patent office, within [***] after receiving the same from the Licensee. The Licensee shall keep BioMedica reasonably informed on the prosecution status of all Joint Patents.
|
(b)
|
If the Licensee wishes to discontinue the prosecution or maintenance of any Joint Patents, BioMedica shall have the right but not the obligation to assume responsibility for the prosecution and maintenance of any Joint Patents at BioMedica’s sole expense.
|
11.3
|
Filing, prosecution and maintenance of Licensed Patents
|
(a)
|
Subject to Clause 11.3(b) (Filing, prosecution and maintenance of Licensed Patents), BioMedica may, in its discretion, prepare, file, prosecute, maintain and defend the
|
(b)
|
If BioMedica wishes to discontinue the prosecution or maintenance of any Product-Specific Patents, the Licensee shall have the right but not the obligation to assume responsibility for the prosecution and maintenance of any such Product-Specific Patents at the Licensee’s sole expense.
|
(c)
|
BioMedica and the Licensee shall discuss in good faith whether and on which Licensed Patents to seek patent term extension or supplemental patent protection, including supplemental protection certificates. BioMedica and the Licensee shall cooperate in good faith in connection with all such activities. Notwithstanding the foregoing, if the Parties cannot agree, BioMedica will determine whether and on which Licensed Patents BioMedica will seek patent term extensions or supplemental patent protection in relation to the relevant Product and the Licensee shall not make any such applications.
|
11.4
|
Enforcement of Joint Patents
|
(a)
|
If either Party becomes aware of any actual or suspected infringement in the Field of any Joint Patent, it will notify the other Party in writing to that effect and include evidence of the alleged infringement by such Third Party.
|
(b)
|
The Licensee shall have the first right, but not the obligation, to initiate an action against a Third Party infringer of any Joint Patent at its cost and expense. Should the Licensee bring an action against a Third Party infringer of a Joint Patent,
|
(c)
|
If the Licensee elects, by notice to BioMedica, not to initiate an action against a Third Party infringer of any Joint Patent or to discontinue such an action, BioMedica shall have the right to initiate (or continue) such an action, at BioMedica’s expense. The Licensee shall have the right to consult with BioMedica with respect to such action and to participate and be represented by independent counsel in any such action initiated by BioMedica, at the Licensee’s expense. BioMedica shall not settle any such action if such settlement would adversely affect or limit the licences granted to the Licensee hereunder without the prior written consent of the Licensee, such consent not to be unreasonably withheld, conditioned, or delayed.
|
11.5
|
Enforcement of Licensed Patents
|
(a)
|
If either Party becomes aware of any actual or suspected infringement in the Field, of any Product-Specific Patents, it will notify the other Party in writing to that effect and include evidence of the alleged infringement by such Third Party.
|
(b)
|
BioMedica shall have the first right, but not the obligation, to initiate an action against a Third Party infringer of Licensed Patents. Should BioMedica bring an action against a Third Party infringer of any Product-Specific Patents, (i) the Licensee shall have the right to consult with BioMedica and to participate and be represented by independent counsel in any action initiated by BioMedica at the Licensee’s expense, (ii) BioMedica shall keep the Licensee reasonably informed regarding the progress of any litigation and settlement discussion with any alleged infringer, (iii) BioMedica shall copy the Licensee on all documents and correspondence other than routine procedural documents and correspondences, and (iv) the Licensee shall have the right to provide ongoing comments on documents prior to submission and advice regarding its position and interests in such action, which timely advice and comments will be considered in good faith by BioMedica. BioMedica shall retain the sole control of any infringement action filed against any Third Party infringer pursuant to this Clause 11.5(b) (Enforcement of Licensed Patents) and shall bear all costs and expenses in connection therewith. BioMedica shall not settle any such action if such settlement would adversely affect or limit the licences granted to the Licensee hereunder without the prior written consent of the Licensee, such consent not to be unreasonably withheld or delayed.
|
(c)
|
If BioMedica elects, by notice to the Licensee, not to initiate an action against a Third Party infringer of any Product-Specific Patents or to discontinue such an action, but not in any other circumstances, the Licensee shall have the right to initiate (or continue) such an action (if required by Applicable Law, in the name of and on behalf of, BioMedica), at the Licensee’s expense. Should the Licensee bring an action against a Third Party infringer of a Product-Specific Patent, (i) the Licensee shall keep BioMedica reasonably informed regarding the progress of any litigation and settlement discussion with any alleged infringer, (ii) the Licensee shall copy BioMedica on all documents and correspondence other than routine procedural documents and correspondences, (iii) BioMedica shall have the right to provide ongoing comments on documents prior to submission and advice regarding its position and interests in such action, which timely
|
11.6
|
Enforcement Generally
|
(a)
|
Any recoveries obtained by either Party as a result of any proceeding against a Third Party infringer under Clause 11.4 (Enforcement of Joint Patents) or Clause 11.5 (Enforcement of Licensed Patents) shall first be used to reimburse each Party for all litigation costs paid by that Party in connection with such litigation on a pro rata basis and second, any remainder after the reimbursement of litigation costs shall be split between the Parties in proportion to the relative contribution of each Party to the total litigation costs.
|
(b)
|
Either Party shall, at the request and expense of the enforcing Party in respect of the Licensed Patents or Joint Patents, as applicable, cooperate to the fullest extent reasonably possible and will lend its name to such actions if required by law in order for the enforcing Party to bring such action. This clause will not be construed to require either Party to undertake any activities, including legal discovery, at the request of any Third Party, except as may be required by lawful process of a court of competent jurisdiction.
|
11.7
|
Third Party Infringement Suit
|
12.
|
CONFIDENTIALITY
|
12.1
|
Duty of Confidence
|
(a)
|
keep the Confidential Information of the Disclosing Party secret and confidential at all times;
|
(b)
|
not disclose or permit the disclosure of any Confidential Information of the Disclosing Party, in whole, in part, or in summary, to any person, except as expressly permitted by this Agreement or any other agreement between the Parties;
|
(c)
|
not use the Confidential Information of the Disclosing Party or permit it to be used, in whole or in part, for any purpose other than performance of the obligations and enjoyment of the rights granted under this Agreement or any other agreement between the Parties; and
|
(d)
|
inform the Disclosing Party immediately if it becomes aware of the possession, use or knowledge of any of the Confidential Information of the Disclosing Party by an unauthorised person, and to provide any assistance in relation to such unauthorised possession, use or knowledge that the Disclosing Party may require.
|
12.2
|
Representatives
|
(a)
|
reasonably require such access for the performance of the obligations or enjoyment of the rights granted under this Agreement;
|
(b)
|
have been informed of the confidential nature of such Confidential Information, the Disclosing Party’s interest in such Confidential Information, and the provisions of this Clause 12 (Confidentiality) ; and
|
(c)
|
have entered into legally binding confidentiality obligations to the Receiving Party on terms that are no less onerous than those set out in this Agreement, and which extend to such Confidential Information.
|
12.3
|
Exceptions
|
(a)
|
was known to the Receiving Party prior to disclosure by the Disclosing Party;
|
(b)
|
is or becomes publicly known other than as a result of breach of this Agreement by the Receiving Party or by anyone to whom the Receiving Party disclosed the Confidential Information of the Disclosing Party;
|
(c)
|
is received by the Receiving Party from a Third Party lawfully entitled to make the disclosure without restrictions on such Third Party’s rights to disclose or use; or
|
(d)
|
is developed by or on behalf of the Receiving Party without any direct or indirect access to, or use of, the Confidential Information of the Disclosing Party;
|
12.4
|
Required Disclosures
|
(a)
|
give reasonable advance notice to the Disclosing Party of the proposed disclosure
|
(b)
|
use efforts to secure confidential treatment of such Confidential Information at least as diligent as such Party would use to protect its own Confidential Information, but in no event less than reasonable efforts;
|
(c)
|
take all reasonable action to avoid disclosure of Confidential Information hereunder; and
|
(d)
|
take into account reasonable requests of the Disclosing Party in relation to such disclosure.
|
12.5
|
Additional Disclosures
|
(a)
|
The Licensee may disclose Confidential Information of BioMedica to the extent such disclosure is necessary in connection with sublicensing (or potential sublicensing) the rights granted under this Agreement, provided that, such disclosure is made only under obligations of confidence and non-use at least as stringent as set out in this Agreement and any such sub-licensing is in accordance with this Agreement.
|
(b)
|
BioMedica may disclose, to any licensor or assignor of intellectual property rights to BioMedica, financial Confidential Information of the Licensee provided to
|
(c)
|
Each Party may disclose Confidential Information of the other Party in connection with the filing, prosecuting, or maintaining of Patents as permitted by this Agreement and for Regulatory Filings for a Product, provide that the Licensee shall use efforts to secure confidential treatment of Licensed Know- how in Regulatory Filings at least as diligent as the Licensee would use to protect its own Confidential Information, but in no event less than reasonable efforts.
|
(d)
|
Each Party and its Affiliates may disclose the existence of this Agreement and the material terms hereof to potential and actual investors, acquirers, licensees, sublicensees, and other financial and commercial partners of such Party or its Affiliates in connection with:
|
(i)
|
the raising of finance,
|
(ii)
|
evaluating or carrying out a license or collaboration,
|
(iii)
|
the sale of any equity interest in such Party or its Affiliates, or
|
(iv)
|
the sale of the business or relevant part of the business of the Party or its Affiliates;
|
12.6
|
Return and Destruction of Confidential Information
|
(a)
|
promptly destroy or erase all Confidential Information of the Disclosing Party that the Receiving Party has received under this Agreement including any copies made and permanently delete all electronic copies of any such Confidential Information from the Receiving Party’s computer systems; and
|
(b)
|
make no further use of any such Confidential Information.
|
12.7
|
Press Releases and Publicity
|
12.8
|
Publications
|
12.9
|
Prior Confidentiality Agreement.
|
13.
|
REPRESENTATIONS AND WARRANTIES
|
13.1
|
Mutual Warranties
|
(a)
|
it is duly organised, validly existing, and in good standing under the laws of its jurisdiction of formation;
|
(b)
|
it has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate action required by law and its organisational documents to authorise the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement;
|
(c)
|
all consents, approvals and authorisations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and
|
(d)
|
the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement do not and shall not (i) conflict with or result in a breach of any provision of its organisational documents, (ii) result in a breach of any agreement to which it is a party; or (iii) violate any Applicable Law.
|
13.2
|
BioMedica Warranties
|
(a)
|
except as identified in
Schedule 1
, there are no claims, demands, challenges, oppositions, nullity actions, interferences, inter-partes reexaminations, inter- partes reviews, post-grant reviews, derivation proceedings, litigation, arbitration or other proceedings asserted in writing against BioMedica or its Affiliates (and BioMedica has no knowledge of any claim or any of the foregoing) in respect of (i) the BioMedica IP (other than matters raised in the ordinary course of patent prosecution), including any claim or any of the foregoing alleging that such BioMedica IP is invalid or unenforceable or violates, infringes, constitutes misappropriation or otherwise conflicts or interferes with, or would violate, infringe or otherwise conflict or interfere with, any intellectual property or proprietary right of any Third Party; or (ii) Prosavin or OXB-102;
|
(b)
|
as far as it is aware, BioMedica has filed and prosecuted the Licensed Patents in good faith and complied with all duties of disclosure with respect thereto;
|
(c)
|
as far as it is aware, BioMedica has not committed any act, or omitted to commit any act, that may cause the Licensed Patents to expire prematurely or be declared invalid or unenforceable;
|
(d)
|
as far as it is aware, all application, registration, maintenance and renewal fees in respect of the Licensed Patents as of the date of execution of this Agreement have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining such patents;
|
(e)
|
BioMedica has the right to grant the licences and rights granted under this Agreement;
|
(f)
|
BioMedica has not granted any Third Party rights that would otherwise interfere or be inconsistent with the rights granted hereunder;
|
(g)
|
as of the Effective Date, the Patents listed in Part 1 and Part 2 of
Schedule 1
are all the Patents that BioMedica Controls that Cover the Products;
|
(h)
|
as far as it is aware, no Third Party is infringing or threatening to infringe (i) any Product-Specific Patents, or (ii) any other Licensed Patents in relation to Product;
|
(i)
|
as far as it is aware, BioMedica has independently developed all Know-How within the BioMedica IP or otherwise has a valid right to use and to grant the licenses and rights hereunder in and to such Know-How;
|
(j)
|
BioMedica has no outstanding submissions for publication related to the Products or the Ongoing Clinical Trials except as described in
Schedule 1
; and
|
(k)
|
that certain Nonexclusive Agreement by and between The Board of Trustees of the Leland Stanford Junior University Stanford Agreement and Oxford BioMedica (UK) Limited dated as of June 24, 2003 (the “Stanford Agreement”) is in full force and effect, no notice has been delivered of any breach under the Stanford Agreement and no rights granted herein are inconsistent with the Stanford Agreement. As of the Effective Date, BioMedica is in the process of amending and restating the Stanford Agreement, and BioMedica has provided to the Licensee a copy of the Stanford Agreement and current drafts of the amendment of the Stanford Agreement. BioMedica acknowledges that it shall be liable for obtaining any amendment to the Stanford Agreement that may be necessary to enable BioMedica to carry out its obligations under this Agreement, but it is acknowledged and agreed by the Parties that BioMedica is not permitted to sublicense its rights under the Stanford Agreement and that such liability shall not extend to obtaining an amendment to permit such a sublicense.
|
13.3
|
Licensee Warranties
|
(a)
|
there is no action, suit, proceeding, inquiry or investigation brought by or before any governmental entity now pending or, to the knowledge of the Licensee, threatened, against or affecting the Licensee or any of its Affiliates, which would reasonably be expected, individually or in the aggregate, materially and adversely affect the performance by the Licensee of its obligations hereunder; and the aggregate of all pending legal or governmental proceedings to which the Licensee or any of its Affiliates is a party or of which any of their respective properties or assets is the subject, including ordinary routine litigation incidental to the business, if determined adversely to the Licensee, would not reasonably be expected to materially and adversely affect the performance by the Licensee of its obligations hereunder; and
|
(b)
|
each of the Licensee and its Affiliates is insured by recognized, financially sound and reputable institutions with policies in such amounts and with such deductibles and covering such risks as are generally deemed adequate and customary for their businesses, including directors’ and officers’ liability insurance and policies covering real and personal property owned or leased by the Licensee and its Affiliates against theft, damage, destruction and acts of vandalism and policies covering the Licensee and its Affiliates for product liability claims and clinical trial liability claims; and the Licensee has no reason to believe that it or its Affiliates will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that would not reasonably be expected to materially and adversely affect the performance by the Licensee of its obligations hereunder; and neither the Licensee nor any of its Affiliates has been denied any insurance coverage which it has sought or for which it has applied.
|
13.4
|
No Other Warranties.
|
14.
|
LIABILITY, INDEMNIFICATION AND INSURANCE
|
14.1
|
Liability
|
(a)
|
Each Party shall be liable for any acts or omissions of its Affiliates or any Sublicensees that would, if effected by such Party, constitute a breach of this Agreement.
|
(b)
|
EXCEPT WITH RESPECT TO BREACHES OF CLAUSE 12 (CONFIDENTIALITY) AND TO THE PARTIES’ INDEMNIFICATION OBLIGATIONS IN CLAUSE 14.2 (LICENSEE INDEMNIFICATION) AND CLAUSE 14.3 (BIOMEDICA INDEMNIFICATION), IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS (BUT ONLY TO THE EXTENT THAT SUCH LOST PROFITS ARE SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES), UNDER ANY THEORY OR CLAIM WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHER
|
(c)
|
Nothing in this Agreement shall exclude or limit, or purport to exclude or limit, a Party’s liability in the case of:
|
(i)
|
breach of Clause 12 (Confidentiality);
|
(ii)
|
fraud or fraudulent misrepresentation;
|
(iii)
|
death or personal injury resulting from its negligence;
|
(iv)
|
negligence or intentional misconduct; or
|
(v)
|
any other matter in respect of which it would be unlawful to exclude or restrict liability.
|
14.2
|
Licensee Indemnification
|
(a)
|
The Licensee shall indemnify BioMedica and its Affiliates, and their respective officers, directors, employees, contractors and agents (the “BioMedica Indemnitees”), from and against any and all losses, liabilities, damages, reasonable legal costs and other reasonable expenses of any nature whatsoever suffered or incurred in connection with any Third Party demands, claims, actions, or proceedings (each, a “Claim”) against a BioMedica Indemnitee arising out of (i) the research, development, use, manufacture, offer for sale, sale, import or export of any Product by or on behalf of the Licensee or its Affiliates or any Sublicensees (except to the extent that such Claim arises out of a breach by BioMedica of Clause 7.2(c) (Existing Inventory) or the supply by BioMedica of defective product in breach of any clinical or commercial supply agreement, with such concepts being defined and interpreted in accordance with such supply agreement) other than the Manufacture of Product by or on behalf of BioMedica; (ii) the negligence or wilful misconduct on the part of the Licensee Indemnitees; or (iii) implementation by BioMedica of any written instructions or directions of the Licensee in connection with the Ongoing Clinical Trials; (iv) the breach by the Licensee of any warranty or covenant made by the Licensee in this Agreement; except in each case except to the extent that such Claim arises out of the negligence of, wilful misconduct of, or breach of this Agreement by the BioMedica Indemnitees.
|
(b)
|
The Licensee shall indemnify the BioMedica Indemnitees for all costs incurred by the BioMedica Indemnitees in connection with provision, after the Effective Date, of clinical intervention or compensation to patients in the Ongoing Clinical Trials who may suffer injury or death or personal injury in connection with such Ongoing Clinical Trials after responsibility for such Ongoing Clinical Trials has been transferred to Licensee pursuant to Clause 4.1 (Transfer of Know-How and Ongoing Clinical Trials), except to the extent that such intervention or compensation is rendered necessary due to the negligence or wilful misconduct on the part of a BioMedica Indemnitee or failure by a BioMedica Indemnitee to perform the Ongoing Clinical trials in accordance with a specific written instruction of the Licensee.
|
14.3
|
BioMedica Indemnification
|
(a)
|
BioMedica shall indemnify the Licensee and its Affiliates, and their respective officers, directors, employees, contractors, and agents (the “Licensee Indemnitees”), from and against any and all losses, liabilities, damages, reasonable legal costs and other reasonable expenses of any nature whatsoever suffered or incurred in connection with any Claim against a Licensee Indemnitee arising out of (i) the negligence or wilful misconduct on the part of the BioMedica Indemnitees; (ii) the development or use of the Products by BioMedica or its Affiliates or sublicensees prior to the Effective Date or (iii) the breach by BioMedica of any warranty or covenant made by BioMedica in this Agreement; except in each case to the extent that such Claim arises out of the negligence of, wilful misconduct of, or breach of this Agreement by the Licensee Indemnitees.
|
(b)
|
BioMedica shall indemnify the Licensee Indemnitees for all costs incurred by the Licensee Indemnitees in connection with provision of clinical intervention or compensation to patients who were treated with the Product prior to the Effective Date in any Ongoing Clinical Trial of the Product who may suffer injury or death or personal injury in connection with such Clinical Trials.
|
14.4
|
Indemnification Procedure
|
(a)
|
the Indemnified Party shall provide prompt written notice to the Indemnifying Party of the assertion or commencement of any Claims;
|
(b)
|
the Indemnifying Party shall have the right to assume (with its own counsel and at its own costs) sole control of the defence or settlement of the same and shall not be liable for any settlement made by the Indemnified Party without the Indemnifying Party’s prior written consent;
|
(c)
|
the Indemnified Party shall:
|
(i)
|
promptly provide all assistance and information reasonably required by the Indemnifying Party;
|
(ii)
|
not make any admission of liability, conclude any agreement or make any compromise or settlement with any person in relation to such Claim without the prior written consent of the Indemnifying Party; and
|
(iii)
|
have the right to participate in (but not control) the defence of the Claim and to retain its own counsel in connection with such Claim at its own expense.
|
14.5
|
Mitigation of Loss
|
14.6
|
Insurance
|
15.
|
TERM AND TERMINATION
|
15.1
|
Term
|
15.2
|
Termination
|
(a)
|
The Licensee may terminate the Agreement at any time for convenience upon (i) two (2) months’ prior written notice prior to the First Commercial Sale of a Product; or (ii) [***] written notice to BioMedica after the First Commercial Sale of a Product.
|
(b)
|
Material Breach
|
(i)
|
Allegation and Cure. If either Party is in material breach of any obligation hereunder (including failure by the Licensee to make a payment due under this Agreement), the non-breaching Party may give written notice in good faith to the alleged breaching Party specifying the claimed particulars of such breach. If such alleged breach is not cured within [***] after such notice (or [***] with respect to any failure to make any payment due under this Agreement), the non- breaching Party shall have the right thereafter to terminate this Agreement pursuant to Clause 15.2(b)(iii) (Right to Terminate); provided, however, that if such breach is capable of being cured but cannot be cured within such [***] period, the breaching Party shall have the right to cure such breach during an additional period as is reasonable in the circumstances by initiating actions to cure such breach during such [***] period and diligently pursuing such actions.
|
(ii)
|
Disputes. If either Party disputes any aspect of this Clause 15.2(b) (Material Breach) (including, for example, (x) the alleged breaching Party disputes in good faith the existence or materiality of such breach; or (y) the non-breaching Party disputes in good faith the diligent pursuit of actions to cure such breach), then
|
(iii)
|
Right to Terminate.
|
(A)
|
Agreement of Material Breach. If the Parties agree in writing that there has been a material breach of an obligation and the relevant cure period in Clause 15.2(b)(i) (Allegation and Cure) has expired without cure, then the non-breaching Party shall have the right thereafter to terminate this Agreement immediately by giving written notice to the breaching Party.
|
(B)
|
Determination of Material Breach. Subject to sub-clauses (C), (D), and (E) below, if the tribunal under Clause 16.15 (Dispute Resolution; Arbitration) finally determines that there has been a material breach of any obligation under this Agreement and the relevant cure period in Clause 15.2(b)(i) (Allegation and Cure) has expired without cure, the non-breaching Party shall have the right thereafter to terminate this Agreement immediately by giving written notice to the breaching Party within [***] following such final determination of the tribunal; provided, for clarity, that the Licensee may cure any such breach prior to determination by the tribunal that there has been a material breach.
|
(C)
|
Cure of Material Breaches other than Diligence. For a material breach of any obligation under this Agreement other than Clause 6.5 (Diligence), the breaching Party shall have the right to cure such breach within [***] following such final determination of the tribunal and the non-breaching Party may not terminate if such breach is cured in such period.
|
(D)
|
Cure of Material Breach of Diligence Prior to First Commercial Sale. For a material breach of a diligence obligation under Clause 6.5 (Diligence) prior to First Commercial Sale of a Product in the United States or any country in Europe, Licensee shall have no right to cure such breach following such final determination of the tribunal.
|
(E)
|
Cure of Material Breach of Diligence After First Commercial Sale. For the first material breach of a diligence obligation under Clause 6.5 (Diligence) after First Commercial Sale of a Product in the United States or any country in Europe, the Licensee may cure such breach within a reasonable period of time (as is determined by the tribunal) following the final determination by the tribunal of such breach and Licensor may not terminate this Agreement for so long as Licensee is diligently pursuing actions to cure such breach. For any subsequent material breach of a diligence obligation under Clause 6.5 (Diligence) after First Commercial Sale of a Product in the United States or any country in Europe, the Licensee shall not have the right to cure such breach
|
(c)
|
Either Party may terminate this Agreement upon notice to the other Party if an Insolvency Event occurs in relation to the other Party and such Insolvency Event is not dismissed or remedied within [***] after its occurrence. Unless otherwise prohibited by Applicable Laws, in any event when a Party first becomes aware of the likely occurrence of any Insolvency Event in regard to that Party, it shall promptly so notify the other Party in sufficient time to give the other Party sufficient notice to protect its interests under this Agreement.
|
15.3
|
Consequences of Termination
|
(a)
|
In the event of termination of this Agreement, such termination shall be deemed to be a termination of all outstanding Work Packages.
|
(b)
|
In the event of termination of this Agreement, the Licensee shall, as directed by BioMedica, wind-down any ongoing Clinical Trials with respect to the Product in an orderly fashion and in compliance with all Applicable Laws.
|
(c)
|
In the case of termination of this Agreement:
|
(i)
|
all rights and licences granted hereunder to the Licensee or its Affiliates shall terminate except that the Licensee and its Affiliates shall have the right to sell any Product in its or their possession or control (or the subject of a binding non-cancellable order with a Third Party manufacturer) for a period not to exceed [***] from the date of termination, subject to payment of any applicable royalties under this Agreement;
|
(ii)
|
the Licensee shall consent to the cancellation of any formal licence granted to it, or of any registration of it in any register, in relation to any BioMedica IP;
|
(iii)
|
subject to Clause 2.4(b)(iv) (Sublicensing), any sub-licences granted by the Licensee or its Affiliates pursuant to this Agreement shall terminate;
|
(iv)
|
to the extent the Licensee owns or holds any right, title or interest in any Product Marks under which any Product has been or is being marketed or sold, the Licensee shall assign such Product Marks to BioMedica (it being understood that the foregoing will not include any trademarks or internet domain names that contain the corporate or business names of the Licensee or its Affiliates);
|
(v)
|
the Licensee shall and shall procure that its Affiliates and Sublicensees shall, (1) promptly assign and transfer to BioMedica or its nominee, at no cost (except as set out below) to BioMedica all Regulatory Filings and Regulatory Approvals held by the Licensee or its Affiliates or Sublicensees that solely and specifically relate to the Product and shall provide BioMedica with all information, and execute all documents, reasonably necessary to transfer such Regulatory Filings and Regulatory Approvals to BioMedica, provided that BioMedica shall reimburse the Licensee, at the then current Licensee FTE rate, for time spent in
|
(vi)
|
the Licensee shall and shall procure that its Affiliates and Sublicensees shall grant to BioMedica an exclusive licence under (1) all Patents that Cover the Product as then being developed or commercialised by the Licensee and (2) the Know-How that is necessary or reasonably useful for the research, development, manufacture, use, sale, import and export of the Products, in each case that are Controlled by the Licensee, its Affiliates, and Sublicensees as of the effective date of termination, solely to research, develop, manufacture, have manufactured, use, sell, have sold, import and export such Products; and
|
(vii)
|
the Licensee shall and shall procure that its Affiliates and Sublicensees shall, promptly transfer to BioMedica or its nominee a copy of all Know- How licensed under Clause 15.3(c)(vi) (Termination), provided that BioMedica shall reimburse the Licensee, at the then-current Licensee FTE rate, for time spent in connection with such transfer to BioMedica.
|
(d)
|
The following Clauses shall survive any expiration or termination of this Agreement for the period of time specified therein (or, if no such period is specified, indefinitely): Clause 1 (Definitions) to the extent defined terms are contained in surviving Clauses; Clause 8 (Monetary Obligations) with respect to those payments that accrued prior to the effective date of termination or expiration or pursuant to Clause 15.3(c)(i) (Consequences of Termination); Clause 9 (Payments and Reports); Clause 10.1 (Records) with respect to those records created pursuant to the Agreement; Clause 10.2 (Audit); Clause 11.1 (Ownership) with respect to Inventions, Joint Inventions and Joint Patents; Clause 11.2 (Filing, prosecution and maintenance of Joint Patents); Clause 12 (Confidentiality); Clause 13.4 (No Other Warranties); Clause 14 (Liability, Indemnification, and Insurance); Clause 15.3 (Consequences of Termination); Clause 15.4 (Termination Not Sole Remedy); Clause 16.5 (Notice and Other Communications); Clause 16.9 (Entire Agreement); Clause 16.11 (Waiver of Rights); Clause 16.12 (Unenforceable Provisions); Clause 16.14 (Governing Law); Clause 16.15 (Dispute Resolution; Jurisdiction);Clause16.16 (Equitable Relief); and Clause 16.17 (Cumulative Remedies).
|
15.4
|
Termination Not Sole Remedy
|
16.
|
GENERAL
|
16.1
|
Term Loan Agreement.
|
(a)
|
The Parties agree and acknowledge:
|
(i)
|
that BioMedica obtained external financing pursuant to a Term Loan Agreement dated 29 June 2017 between BioMedica as borrower, Oxford BioMedica plc, as guarantor, Cortland Capital Market Services LLC, as administrative agent, OCM Strategic Credit Investments S.à.r.l., OCM Strategic Credit Investments 2 S.à.r.l., OCM Luxembourg SC Fund A S.à.r.l., and OCM Luxembourg SC Fund B S.à.r.l. as lenders (“Oaktree”) (the “Loan Agreement”);
|
(ii)
|
that the extension of credit pursuant to the Loan Agreement is secured by all or substantially all of BioMedica’s assets pursuant to a debenture governed by English law granted in favour of Cortland Capital Market Services LLC as agent for the lender (the “Lender Agent”), excluding the Product-Specific Patents, but which may include, inter alia, a charge over Oxford BioMedica’s right, title and interest in and to this Agreement (the “Charge”); and
|
(iii)
|
that notwithstanding the granting of the Charge, BioMedica shall remain liable under this Agreement to perform all of its obligations under this Agreement and shall remain entitled to exercise all its rights, powers and discretions under this Agreement unless and until the Licensee receives notice from Oaktree or the Lender Agent to the contrary informing the Licensee that an Event of Default (as defined in the Loan Agreement) has occurred, when all such rights, powers and discretions shall be exercisable by, and notices shall be given to, the Lender Agent or as it directs.
|
(b)
|
Pursuant to the terms of the Loan Agreement and the Charge, the Licensee hereby consents:
|
(i)
|
to the grant of the Charge;
|
(ii)
|
upon an Event of Default, to the assumption by the Lender Agent (or other nominee of the lenders under the Loan Agreement) of BioMedica’s rights under this Agreement; and
|
(iii)
|
to BioMedica’s disclosure (subject to the confidentiality terms set out in the Loan Agreement, provided that, such confidentiality terms are at least as protective to the Licensee’s Confidential Information as the terms set forth in this Agreement) to the Lender Agent and Oaktree of this Agreement and any non-technical information exchanged between the Parties, solely to the extent required in order for BioMedica to comply with its obligations to the Lender Agent and Oaktree under the Charge.
|
(iv)
|
the Licensee will sign and return two (2) original copies of the receipt of notice set out at
Schedule 4
to BioMedica within [***] of the Effective Date.
|
16.2
|
Force Majeure
|
16.3
|
Compliance with Law
|
16.4
|
Further Action
|
16.5
|
Notices and Other Communications
|
16.6
|
Amendment
|
16.7
|
Assignment
|
(a)
|
the assigning Party shall provide the non-assigning Party with prompt written notice of any such assignment; and
|
(b)
|
the permitted assignee shall assume the obligations of the assigning Party hereunder in writing.
|
16.8
|
Third Party Rights
|
16.9
|
Entire Agreement
|
16.10
|
Relationship
|
16.11
|
Waiver of Rights
|
16.12
|
Unenforceable Provisions
|
16.13
|
Counterparts
|
16.14
|
Governing Law
|
16.15
|
Dispute Resolution; Arbitration
|
16.16
|
Interim or Provisional Relief
|
16.17
|
Cumulative Remedies
|
16.18
|
Performance by Affiliates
|
Signature:
|
/s/ John Dawson
|
Name:
|
John Dawson
|
Title:
|
CEO
|
Signature:
|
/s/ Mark Altmeyer
|
Name:
|
Mark Altmeyer
|
Title:
|
President
|
Team Member
|
Role
|
% FTE dedicated to AXON
|
|
[***]
|
Clinical Lead
|
[***]%
|
|
[***]
|
Senior Clinical Study Manager
|
[***]%
|
|
[***]
|
Senior Clinical Study Manager
|
[***]%
|
|
[***]
|
Regulatory Lead
|
[***]%
|
|
[***]
|
Pharmacovigilance
|
[***]%
|
|
[***]
|
Medical Monitor
|
[***]%
|
|
[***]
|
Project Manager
|
[***]%
|
|
To be confirmed
|
Quality Assurance
|
[***]%
|
|
To be confirmed
|
Senior Clinical Study Administrator
|
[***]%
|
|
(1)
|
OXFORD BIOMEDICA (UK) LIMITED, a company incorporated in England and registered under number 03028927, whose registered office is at Medawar Centre,
|
(2)
|
AXOVANT SCIENCES GMBH, a corporation organized and existing under the laws of Switzerland, having its principal place of business at Viaduktstrasse 8, 4051 Basel, Switzerland (the “Licensee”).
|
1.
|
SUBSTANTIVE PROVISIONS
|
Work Package reference
|
Work Package [●]
|
Version number
|
|
Agreement to which this Work Package relates
|
License Agreement dated June 5, 2018 between Oxford BioMedica and the Licensee
|
Title of Work Package
|
|
Scope of Work Package (brief overview)
|
insert ‘See above’ if title provides sufficient overview
|
Expected start date
|
|
Estimated duration of Work Package
|
|
Estimated costs of Work Package
time and material work packages to include estimated resource costs, estimated FTE days, estimated materials and external costs, total estimated amount for services and materials, and payment schedule; fixed cost work packages to include detailed payment schedule
|
|
Materials to be provided by BioMedica
|
|
Materials to be provided by the Licensee
|
|
Information to be provided by the Licensee
|
|
Deliverables
|
|
2.
|
DETAILED DESCRIPTION OF ACTIVITIES TO BE COMPLETED UNDER WORK
|
2.1
|
[work plan]
|
3.
|
TERM AND TERMINATION
|
3.1
|
Unless terminated earlier in accordance with the terms of the Agreement or this Clause 3, this Work Package shall continue until all obligations under this Work Package have been performed.
|
3.2
|
The Licensee may terminate this Work Package for any reason by giving not less than [***] prior written notice to BioMedica and upon expiry of such notice, this Work Package shall be terminated and the parties shall proceed in accordance with Clause 3.4 of this Work Package.
|
3.3
|
If either Party is in breach of any material obligation under this Work Package (including failure by the Licensee to make an payment due in connection with this Work Package), the non-breaching Party may give written notice to the breaching Party specifying the claimed particulars of such breach, and in the event such breach is not cured within [***] after such notice (or [***] with respect to any failure to make any payment due under this Work Package), the non-breaching Party shall have the right thereafter to terminate this Work Package immediately by giving written notice to the breaching Party; provided, however, that if such breach is capable of being cured but cannot be cured within such cure period and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have such additional period as is reasonable in the circumstances to cure such breach.
|
3.4
|
In the event of termination of this Work Package:
|
(a)
|
the Parties shall cease all work related to this Work Package and have no further obligations to perform activities under this Work Package, save that the Parties shall carry out those limited activities as are necessary for an orderly wind-down of the relevant Work Package;
|
(b)
|
the Licensee shall pay to BioMedica following receipt of a reasonably detailed invoice all undisputed amounts due and all approved expenses actually incurred by BioMedica in relation to the performance of this Work Package prior to the effective date of termination and orderly wind-down activities (provided that BioMedica shall pay costs of wind-down activities if termination is due to BioMedica’s uncured material breach under Clause 3.3 of this Work Package).
|
4.
|
[ADDITIONAL TERMS]
|
To:
|
Axovant Sciences GmbH Viaduktstrasse 8
|
With a copy to:
|
The Legal Department and Ryan Morick Cortland Capital Market Services LLC
|
(i)
|
in the event of any conflict between communications received from it and from the Administrative Agent, the communication from the Administrative Agent shall prevail;
|
(ii)
|
none of the instructions, authorisations or confirmations in this Notice of Charge (the “Notice”) can be revoked or varied in any way except with the Administrative Agent’s specific written consent; and
|
(iii)
|
any written notice or instructions given to you by the Administrative Agent in accordance with this Notice shall be conclusive.
|
Address:
|
225 W. Washington Street,
|
(a)
|
we will pay all moneys hereafter becoming due to Oxford BioMedica (UK) Limited (“Oxford BioMedica”) in respect of the Agreement as directed in the Notice and accept and will comply with the terms of the Notice;
|
(b)
|
we will send to you copies of any notices which we may give to Oxford BioMedica under the Agreement at the same time as we send them to Oxford BioMedica;
|
(c)
|
we have not received notice of any other charge, assignment or other Third Party right or interest whatsoever in, of, over, or affecting, Oxford BioMedica’s interests in the Agreement or any other notice relating to the Agreement; and
|
(d)
|
this acknowledgement is freely assignable or transferable by you, by any subsequent assignee, transferee or successor in title in accordance with the terms of the Agreement (“Subsequent Party”) and by any receiver appointed by you or by any Subsequent Party pursuant to the Debenture.
|
(a)
|
[***];
|
(b)
|
[***];
|
(b)
|
[***];
|
(c)
|
[***];
|
(d)
|
[***];
|
(e)
|
[***];
|
(f)
|
[***];
|
(g)
|
[***];
|
(h)
|
[***]; and
|
(i)
|
[***];
|
•
|
The clinical supply price shall not exceed the cGMP Batch price for current 200L transient serum-free suspension process remains at [***].
1
|
•
|
Work that is not on a batch basis, such as process characterisation, will be invoiced at the FTE Rate.
|
•
|
The Licensee to have the right to technology transfer of the manufacturing process if there is a prolonged failure by BioMedica to supply Product (to be defined in such agreement, but which shall include, (i) an objective, backward-looking standard, such as repeated failure to supply the Licensee with quantities ordered and (ii) a subjective, forward-looking standard, such as reasonably likely failure as a result of catastrophe or other circumstances beyond the reasonable control of BioMedica), without prejudice to the rights under Clause 7.3 (Technology Transfer) of this Licence Agreement.
|
•
|
BioMedica reserves the right to review the FTE Rates and cGMP batch prices on an annual basis from 2019 onwards.
|
•
|
Quality Agreement to be put in place between BioMedica Quality personnel and the Licensee Quality personnel to regulate matters in relation to the supply agreement.
|
•
|
The Licensee to provide [***] batch forecast with [***] binding period. BioMedica agrees to maintain the capacity and availability to supply the Licensee with quantities of Product consistent with such forecasts.
|
•
|
The price for the Product for use by Licensee for commercial purposes will be on a batch-by-batch basis that is consistent with, and in no event less favourable to Licensee than, BioMedica’s other reasonable, normal, and customary manufacturing costing methodology it uses with Third Parties.
|
•
|
Exclusive worldwide license to lentiviral vector gene therapy constitutes the first transaction of Axovant’s 2018 pipeline expansion
|
•
|
Fraser Wright, Co-Founder and former Chief Technology Officer of Spark Therapeutics, to join Axovant as CTO for gene therapy programs
|
•
|
Axovant will receive $25 million equity financing from Roivant Sciences to support clinical development of AXO-Lenti-PD and additional business development
|
•
|
Conference call / webcast today at 8:00am Eastern Time
|
Date: August 7, 2018
|
By:
|
/s/ Pavan Cheruvu
|
|
|
Pavan Cheruvu
|
|
|
Principal Executive Officer
|
Date: August 7, 2018
|
By:
|
/s/ Gregory Weinhoff
|
|
|
Gregory Weinhoff
|
|
|
Principal Financial Officer
|
Date: August 7, 2018
|
By:
|
/s/ Pavan Cheruvu
|
|
|
Pavan Cheruvu
|
|
|
Principal Executive Officer
|
Date: August 7, 2018
|
By:
|
/s/ Gregory Weinhoff
|
|
|
Gregory Weinhoff
|
|
|
Principal Financial Officer
|