|
¨
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
|
x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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SHELL COMPANY PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Title of each class
|
|
Name of each exchange on which registered
|
American Depositary Shares, each representing
5 Ordinary Shares, par value £0.01 per share
|
|
The Nasdaq Stock Market LLC
|
U.S. GAAP
¨
|
International Financial Reporting Standards as issued by the International Accounting Standards Board
x
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Other
¨
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Page
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Item 1:
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Item 2:
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Item 3:
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Item 4:
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Item 4A:
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Item 5:
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Item 6:
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Item 7:
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Item 8:
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Item 9:
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Item 10:
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Item 11:
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Item 12:
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Item 13:
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Item 14:
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Item 15:
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Item 16A:
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Item 16B:
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Item 16C:
|
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Item 16D:
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Item 16E:
|
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Item 16F:
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Item 16G:
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Item 16H:
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Item 17:
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Item 18:
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Item 19:
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•
|
the timing and conduct of our clinical trials of ezutromid (formerly SMT C1100) for the treatment of patients with Duchenne muscular dystrophy and ridinilazole (formerly SMT19969) for the treatment of patients with
Clostridium difficile
infection, including statements regarding the timing of initiation and completion of the clinical trials and the period during which the results of the clinical trials will become available;
|
•
|
the timing of and our ability to obtain marketing approval of ezutromid and ridinilazole, and the ability of ezutromid and ridinilazole to meet existing or future regulatory standards;
|
•
|
our plans to continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta Therapeutics, Inc., or Sarepta;
|
•
|
our plans to conduct research and development and advance potential new mechanism antibiotic compounds identified and developed under our bacterial genetics-based discovery and development platform;
|
•
|
the potential benefits and future operation of our collaboration with Sarepta;
|
•
|
the potential benefits and future operation of our collaboration with the Biomedical Advanced Research and Development Authority, or BARDA;
|
•
|
the potential benefits and future operation of our license and commercialization agreement with Eurofarma Laboratórios SA;
|
•
|
the potential benefits of our acquisition of Discuva Limited, or Discuva, including the future operations of the acquired bacterial genetics-based discovery and development platform;
|
•
|
our plans with respect to possible future collaborations and partnering arrangements;
|
•
|
our plans to pursue research and development of other future product candidates;
|
•
|
the potential advantages of ezutromid and ridinilazole;
|
•
|
the rate and degree of market acceptance and clinical utility of ezutromid and ridinilazole;
|
•
|
our estimates regarding the potential market opportunity for ezutromid and ridinilazole;
|
•
|
our sales, marketing and distribution capabilities and strategy;
|
•
|
our ability to establish and maintain arrangements for manufacture of ezutromid and ridinilazole;
|
•
|
our intellectual property position;
|
•
|
our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
|
•
|
the impact of government laws and regulations; and
|
•
|
our competitive position.
|
|
Year Ended January 31,
|
||||||||||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||
|
(in thousands, except per share data)
|
||||||||||||||||||||||
Revenue
|
$
|
36,070
|
|
|
£
|
25,419
|
|
|
£
|
2,304
|
|
|
£
|
—
|
|
|
£
|
—
|
|
|
£
|
—
|
|
Other operating income
|
3,867
|
|
|
2,725
|
|
|
72
|
|
|
1,281
|
|
|
1,888
|
|
|
1,526
|
|
||||||
Operating loss
|
(18,198
|
)
|
|
(12,825
|
)
|
|
(24,853
|
)
|
|
(20,346
|
)
|
|
(12,233
|
)
|
|
(7,027
|
)
|
||||||
Finance income
|
4,393
|
|
|
3,096
|
|
|
8
|
|
|
30
|
|
|
51
|
|
|
9
|
|
||||||
Finance cost
|
(1,652
|
)
|
|
(1,164
|
)
|
|
(862
|
)
|
|
(2,879
|
)
|
|
(499
|
)
|
|
(385
|
)
|
||||||
Income tax credit
|
5,338
|
|
|
3,762
|
|
|
4,336
|
|
|
3,058
|
|
|
1,297
|
|
|
607
|
|
||||||
Loss for the period
|
(10,119
|
)
|
|
(7,131
|
)
|
|
(21,371
|
)
|
|
(20,137
|
)
|
|
(11,384
|
)
|
|
(6,796
|
)
|
||||||
Basic and diluted loss per ordinary share from continuing operations
|
$
|
(0.15
|
)
|
|
£
|
(0.11
|
)
|
|
(0.35
|
)
|
|
(0.34
|
)
|
|
(0.29
|
)
|
|
(0.33
|
)
|
||||
Weighted average number of shares outstanding (in thousands)
|
65,434
|
|
|
65,434
|
|
|
61,549
|
|
|
59,102
|
|
|
39,599
|
|
|
20,510
|
|
|
As of January 31,
|
||||||||||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||
|
(in thousands)
|
||||||||||||||||||||||
Cash and cash equivalents
|
$
|
28,525
|
|
|
£
|
20,102
|
|
|
£
|
28,062
|
|
|
£
|
16,304
|
|
|
£
|
11,265
|
|
|
£
|
2,030
|
|
Working capital
(1)
|
(4,478
|
)
|
|
(3,156
|
)
|
|
(5,621
|
)
|
|
1,327
|
|
|
359
|
|
|
(816
|
)
|
||||||
Total assets
|
76,573
|
|
|
53,962
|
|
|
37,587
|
|
|
25,057
|
|
|
19,396
|
|
|
7,295
|
|
||||||
Accumulated losses reserve
|
(114,794
|
)
|
|
(80,898
|
)
|
|
(73,767
|
)
|
|
(52,396
|
)
|
|
(32,259
|
)
|
|
(47,166
|
)
|
||||||
Total equity/(deficit)
|
$
|
14,012
|
|
|
£
|
9,875
|
|
|
£
|
(3,493
|
)
|
|
£
|
16,080
|
|
|
£
|
12,962
|
|
|
£
|
2,779
|
|
(1)
|
We define working capital as prepayments and other receivables (including current tax receivables) less current liabilities.
|
|
Period End
(1)
|
|
Average
(2)
|
|
Low
|
|
High
|
||||
|
($ per pound sterling)
|
||||||||||
Fiscal Year Ended January 31:
|
|
|
|
|
|
|
|
||||
2014
|
1.645
|
|
|
1.572
|
|
|
1.484
|
|
|
1.661
|
|
2015
|
1.503
|
|
|
1.634
|
|
|
1.502
|
|
|
1.717
|
|
2016
|
1.418
|
|
|
1.518
|
|
|
1.417
|
|
|
1.588
|
|
2017
|
1.259
|
|
|
1.331
|
|
|
1.212
|
|
|
1.469
|
|
2018
|
1.419
|
|
|
1.301
|
|
|
1.215
|
|
|
1.426
|
|
Month Ended:
|
|
|
|
|
|
|
|
||||
October 2017
|
1.328
|
|
|
1.320
|
|
|
1.306
|
|
|
1.133
|
|
November 2017
|
1.351
|
|
|
1.322
|
|
|
1.307
|
|
|
1.351
|
|
December 2017
|
1.353
|
|
|
1.340
|
|
|
1.332
|
|
|
1.353
|
|
January 2018
|
1.419
|
|
|
1.382
|
|
|
1.351
|
|
|
1.426
|
|
February 2018
|
1.379
|
|
|
1.396
|
|
|
1.379
|
|
|
1.413
|
|
March 2018
|
1.403
|
|
|
1.398
|
|
|
1.376
|
|
|
1.424
|
|
April 2018 (through April 6, 2018)
|
1.409
|
|
|
1.405
|
|
|
1.399
|
|
|
1.409
|
|
(1)
|
In the event that the period end fell on a day for which data are not available, the exchange rate on the prior most recent business day is given.
|
(2)
|
The average of the noon buying rate for pounds sterling on the last day of each full month during the relevant year or each business day during the relevant month indicated.
|
•
|
continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
continue the research and development of ridinilazole;
|
•
|
seek to identify and develop additional product candidates, including through our bacterial genetics-based platform for the discovery and development of new mechanism antibiotics;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical development;
|
•
|
ultimately establish a sales, marketing and distribution infrastructure in jurisdictions where we have retained commercialization rights and scale up external manufacturing capabilities to commercialize any product candidates for which we receive marketing approval;
|
•
|
acquire or in-license other product candidates and technology;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, regulatory and scientific personnel;
|
•
|
expand our physical presence; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
|
•
|
successfully initiating and completing clinical trials of ezutromid for the treatment of DMD and ridinilazole for the treatment of CDI;
|
•
|
obtaining approval to market ezutromid for the treatment of DMD and ridinilazole for the treatment of CDI;
|
•
|
protecting our rights to our intellectual property portfolio related to ezutromid and ridinilazole;
|
•
|
contracting for the manufacture of clinical and commercial quantities of ezutromid and ridinilazole;
|
•
|
negotiating and securing adequate reimbursement from third-party payors for ezutromid and ridinilazole; and
|
•
|
establishing sales, marketing and distribution capabilities to effectively market and sell ezutromid in the United States and ridinilazole in the United States and the European Union, as well as other geographies.
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
the number and development requirements of other future product candidates that we pursue;
|
•
|
the costs, timing and outcome of regulatory review of ezutromid, ridinilazole and our other future product candidates;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and manufacturing, for any of our product candidates that receive marketing approval;
|
•
|
subject to receipt of marketing approval, revenue received from commercial sales of ezutromid, ridinilazole or any of our other future product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims;
|
•
|
the amounts we receive from Sarepta under our license and collaboration agreement, including for the achievement of development, regulatory and sales milestones and royalty payments;
|
•
|
our contract with BARDA and whether BARDA elects to pursue its designated options beyond the base period;
|
•
|
the amounts we receive from Eurofarma under our license and commercialization agreement, including for the achievement of development, commercialization and sales milestones and for product supply transfers;
|
•
|
our ability to establish and maintain collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
•
|
the rate of the expansion of our physical presence; and
|
•
|
the costs of operating as a public company in the United States and in the United Kingdom.
|
•
|
successful completion of clinical development;
|
•
|
receipt of marketing approvals from applicable regulatory authorities;
|
•
|
establishing commercial manufacturing arrangements with third-party manufacturers;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity;
|
•
|
protecting our rights in our intellectual property portfolio;
|
•
|
establishing sales, marketing and distribution capabilities;
|
•
|
launching commercial sales of ezutromid or ridinilazole, as applicable, if and when approved, whether alone or in collaboration with others;
|
•
|
acceptance of ezutromid or ridinilazole, as applicable, if and when approved, by patients, the medical community and third-party payors;
|
•
|
effectively competing with other therapies; and
|
•
|
maintaining a continued acceptable safety profile of ezutromid or ridinilazole, as applicable, following approval.
|
•
|
be delayed in obtaining marketing approval for our product candidates;
|
•
|
not obtain marketing approval at all;
|
•
|
obtain approval for indications or patient populations that are not as broad as we intended or desired;
|
•
|
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;
|
•
|
be subject to additional post-marketing testing requirements or restrictions; or
|
•
|
have the product removed from the market after obtaining marketing approval.
|
•
|
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
|
•
|
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;
|
•
|
we may be unable to enroll a sufficient number of patients in our clinical trials to ensure adequate statistical power to detect any statistically significant treatment effects;
|
•
|
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
regulators, institutional review boards or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
|
•
|
we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;
|
•
|
regulators, institutional review boards or independent ethics committees may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
|
•
|
the cost of clinical trials of our product candidates may be greater than we anticipate;
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and
|
•
|
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators, institutional review boards or independent ethics committees to suspend or terminate the clinical trials.
|
•
|
severity of the disease under investigation;
|
•
|
eligibility criteria for the clinical trial in question;
|
•
|
perceived risks and benefits of the product candidate under study;
|
•
|
competition for patients, time and resources at clinical trials sites from other investigational therapies in clinical trials that target the same patient population;
|
•
|
approval of other therapies to treat the indication that is being investigated in the clinical trial;
|
•
|
efforts to facilitate timely enrollment in clinical trials;
|
•
|
patient referral practices of physicians;
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
•
|
the efficacy and potential advantages compared to alternative treatments or competitive products;
|
•
|
the prevalence and severity of any side effects;
|
•
|
the ability to offer our product candidates for sale at competitive prices, including in the case of ridinilazole, which we expect, if approved, will compete with vancomycin and metronidazole, both of which are available in generic form at low prices, and the antibiotic, fidaxomicin, and potentially other approaches to be used as an adjunctive therapy to antibiotics, such as the monoclonal antibody bezlotoxumab, vaccines or fecal therapy;
|
•
|
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 strength of marketing and distribution support;
|
•
|
the availability of third-party coverage and adequate reimbursement;
|
•
|
the timing of any such marketing approval in relation to other product approvals;
|
•
|
support from patient advocacy groups; and
|
•
|
any restrictions on concomitant use of 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 or persuade adequate numbers of physicians to prescribe any future products;
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
reduced resources of our management to pursue our business strategy;
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to clinical trial participants or patients;
|
•
|
loss of revenue;
|
•
|
increased insurance costs; and
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
terminate agreements, in whole or in part, at any time, for any reason or no reason;
|
•
|
unilaterally modify the parties’ obligations under such contracts, subject to government-determined equitable price adjustments;
|
•
|
decline to exercise any option for work beyond the initial base period under multi-year contracts;
|
•
|
suspend contract performance if Congressionally appropriated funding becomes unavailable;
|
•
|
obtain rights to inventions and technical data made or first produced in the performance of such contracts;
|
•
|
audit contract-related costs and fees, including allocated indirect costs;
|
•
|
suspend or debar the contractor from receiving new contracts pending resolution of alleged violations of procurement laws or regulations in the event of wrongdoing by us;
|
•
|
take actions that result in a longer development timeline than expected;
|
•
|
direct the course of a development program in a manner not chosen by the government contractor;
|
•
|
impose U.S. manufacturing requirements for products that embody or that are produced through the use of inventions conceived or first reduced to practice under such contracts;
|
•
|
assert qualified march-in rights to grant licenses to third parties to practice contractor-owned inventions that are conceived or first reduced to practice under such contracts;
|
•
|
pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and
|
•
|
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.
|
•
|
specialized accounting systems unique to government contracts;
|
•
|
potential liability for price adjustments or recoupment of government funds after such funds have been spent;
|
•
|
mandatory disclosure of credible evidence of certain contractual or statutory violations occurring in connection with the contract;
|
•
|
public disclosures of certain contract information, which may enable competitors to gain insights into our research program; and
|
•
|
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action programs and environmental compliance requirements.
|
•
|
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts;
|
•
|
extensive U.S. government regulation of government-funded clinical research activities, including, for example, compliance requirements relating to protection of human and animal research subjects, restrictions on uses of human research materials, and conditions on dissemination of research results.
|
•
|
business ethics and public integrity obligations, which govern areas such as conflicts of interest, the recruitment and hiring of former government employees, bribes and gratuities, and limitations on and mandatory disclosure of lobbying activities, pursuant to laws such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act; and
|
•
|
export control and import laws and regulations.
|
•
|
termination of any government contracts, including our BARDA contract;
|
•
|
suspension of payments;
|
•
|
administrative sanctions, such as long-term monitoring arrangements;
|
•
|
fines; and
|
•
|
suspension, debarment, or exclusion from eligibility for U.S. government contracts, funding programs and regulatory approvals.
|
•
|
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;
|
•
|
collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
|
•
|
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or 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;
|
•
|
a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;
|
•
|
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;
|
•
|
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
|
•
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disputes may arise between the collaborator and us as to the ownership of intellectual property arising during the collaboration;
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we may grant exclusive rights to our collaborators, which would prevent us from collaborating with others;
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disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and
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collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
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reliance on the third party for regulatory compliance and quality assurance;
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the possible breach of the manufacturing agreement by the third party;
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the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
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the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
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litigation involving patients taking our products;
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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restrictions on product distribution or use;
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requirements to conduct post-marketing studies or clinical trials;
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warning or untitled letters;
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withdrawal of the products from the market;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products;
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fines, restitution or disgorgement of profits or revenues;
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suspension or withdrawal of marketing approvals;
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damage to relationships with any potential collaborators;
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unfavorable press coverage and damage to our reputation;
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refusal to permit the import or export of our products;
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product seizure; or
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injunctions or the imposition of civil or criminal penalties.
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The federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federally funded healthcare programs such as Medicare and Medicaid. This statute has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers and formulary managers, among others. Several other countries, including the United Kingdom, have enacted similar anti-kickback, fraud and abuse, and healthcare laws and regulations.
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The federal False Claims Act imposes civil penalties, including 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 or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. The government and qui tam relators have brought False Claims Act actions against pharmaceutical companies on the theory that their practices have caused false claims to be submitted to the government. There is also a separate false claims provision imposing criminal penalties.
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The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
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HIPAA also imposes criminal liability for knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.
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The federal Physician Sunshine Act requirements under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to together as the Affordable Care Act, require manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value made to or at the request of covered recipients, such as physicians and teaching hospitals, and physician ownership and investment interests in such manufacturers. Payments made to physicians and research institutions for clinical trials are included within the ambit of this law.
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Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures. Additionally, some state and local laws require the registration of pharmaceutical sales representatives in the jurisdiction.
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an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;
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expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% starting January 1, 2019) point-of-sale discounts off negotiated prices;
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extension of manufacturers’ Medicaid rebate liability;
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expansion of eligibility criteria for Medicaid programs;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements to report certain financial arrangements with physicians and teaching hospitals;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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the success of competitive products or technologies;
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results of clinical trials of ezutromid, ridinilazole and any other future product candidate that we develop;
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results of clinical trials of product candidates of our competitors;
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changes or developments in laws or regulations applicable to ezutromid and ridinilazole and any other future product candidates that we develop;
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our entry into, and the success of, any collaboration agreements with third parties;
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the operation of our contract with BARDA, and whether BARDA elects to pursue its option work segments beyond the base period;
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developments or disputes concerning patent applications, issued patents or other proprietary rights;
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the recruitment or departure of key personnel;
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the level of expenses related to any of our product candidates or clinical development programs;
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the results of our efforts to discover, develop, acquire or in-license additional product candidates, products or technologies;
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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
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variations in our financial results or those of companies that are perceived to be similar to us;
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changes in the structure of healthcare payment systems;
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market conditions in the biotechnology and pharmaceutical sectors;
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general economic, industry and market conditions;
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the trading volume of ADSs on the Nasdaq Global Market and of our ordinary shares on AIM; and
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the other factors described in this “Risk Factors” section.
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have a majority of the board of directors consist of independent directors;
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require non-management directors to meet on a regular basis without management present;
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adopt a code of conduct and promptly disclose any waivers of the code for directors or executive officers that should address certain specified items;
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have an independent compensation committee;
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have an independent nominating committee;
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solicit proxies and provide proxy statements for all shareholder meetings;
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review related party transactions; and
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seek shareholder approval for the implementation of certain equity compensation plans and issuances of ordinary shares.
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not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
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reduced disclosure obligations regarding executive compensation; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
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*
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We have granted Eurofarma an exclusive license to the commercial rights for ridinilazole in specified countries in South America, Central America and the Caribbean. We retain commercialization rights in the rest of the world.
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†
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We have granted Sarepta an exclusive license to the commercial rights for our utrophin modulator pipeline, including ezutromid, in the European Union, Iceland, Norway, Switzerland, Turkey and the Commonwealth of Independent States, with an option to expand its commercial rights to include specified countries in Central and South America. We retain commercialization rights in the rest of the world.
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Trial
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Description
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Duration of
Treatment
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Total No.
of Patients
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No. of Patients
Treated with
Ezutromid
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Phase 1 healthy volunteer trial (Trial 01)
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Double blind, placebo controlled, ascending single and multiple oral dose trial
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10 days
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49
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36
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Phase 1b DMD patient trial (Trial 02)
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Open label, ascending single and multiple oral dose trial
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10 days
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12
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12
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Phase 1b modified diet trial (Trial 03)
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Double blind, randomized, placebo controlled multiple oral dose trial with dietary guidance
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14 days
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12
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12
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Phase 1 healthy volunteer and DMD patient trial (Trial 04)
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Open label, ascending multiple oral dose trial with dietary guidance evaluating new F6 formulation of ezutromid
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5 days (healthy volunteers) and 7 days (DMD patients)
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24
(16 healthy
volunteers,
8 DMD
patients)
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24
(16 healthy
volunteers,
8 DMD
patients)
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Ezutromid was Well Tolerated
. In both Part 1 and Part 2 of the clinical trial, ezutromid was well tolerated at all doses tested. The only observed treatment related adverse event was pale stools, which only occurred at the 200 mg/kg and 400 mg/kg dose levels. The pale stools were attributed to unabsorbed ezutromid passing through the gastrointestinal tract at these higher dose levels. All other adverse events were mild in severity and resolved without treatment.
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Higher Plasma Concentrations When Ezutromid Dosed with Food
. The dietary state of subjects in the clinical trial had a meaningful effect on systemic exposure. As illustrated in the figure below, after we administered a single dose of 200 mg/kg of ezutromid to subjects in the 200 mg/kg cohort of Part 1 of the clinical trial, the mean plasma concentration of drug in the blood over time, as determined by quantification of the area under the curve, in the subjects when they were in a fed state (n = 6) was approximately five times higher than the same subjects when they were in a fasted state (n = 5).
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Targeted Plasma Levels Achieved in All Subjects after Multiple Dosing
. When we administered 100 mg/kg doses of ezutromid twice a day for ten days, the steady state plasma concentration achieved in all subjects was greater than 0.2 µM (67 ng/mL), which was the concentration that corresponded to a 50% increase in utrophin protein levels in our preclinical studies described in more detail below. The mean blood plasma concentration of ezutromid in the 12 hours following administration of the final dose is illustrated in the figure below. However, there were differences among subjects, with the amount of time that each subject had plasma concentrations of utrophin protein greater than 0.2 µM ranging from seven to 12 hours following dosing. Utrophin protein has a half-life of three to four weeks, and we believe that a few hours of exposure to ezutromid following regular dosing may lead to an accumulation of utrophin protein in muscle tissue over time. Subjects receiving 200 mg/kg doses of ezutromid twice a day for ten days did not achieve higher plasma concentrations of ezutromid than subjects receiving 100 mg/kg doses of ezutromid on this dosing schedule. As a result, we expect that the maximum dose of ezutromid in our future clinical trials will be 100 mg/kg.
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Stable Plasma Levels of Ezutromid When Administered Through Multiple Dosing
. When we administered 100 mg/kg doses of ezutromid twice a day for ten days with meals, all subjects achieved stable, or steady state, blood plasma concentrations of drug within three to five days after the beginning of dosing. However, we observed differences in plasma concentrations across subjects, which we believe resulted from varying levels of activity of CYP1A, a liver enzyme that metabolizes ezutromid, in different subjects.
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a single 50 mg/kg dose on day one;
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50 mg/kg doses administered twice per day on days two to ten; and
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a single 50 mg/kg dose on day 11.
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a single 100 mg/kg dose on day one;
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100 mg/kg doses administered twice per day on days two to ten; and
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a single 100 mg/kg dose on day 11.
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a single 100 mg/kg dose on day one;
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100 mg/kg doses administered three times per day on days two to ten; and
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a single 100 mg/kg dose on day 11.
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Ezutromid was Well Tolerated
. Ezutromid was well tolerated at all doses tested in this clinical trial with no serious adverse events reported. All reported adverse events were mild in severity and gastrointestinal in nature. In the opinion of the trial investigator, there were no clinically meaningful changes in physical examination, vital signs and hematology or biochemistry parameters in any of the patients. We also did not observe any issues with patient compliance.
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Patients had Variable Plasma Levels of Ezutromid; Possible Impact from Diet on Absorption of Ezutromid
. We observed variability among patients in all three cohorts in plasma concentrations of ezutromid after administering multiple daily doses for eleven days. As illustrated in the figure below, the mean blood plasma concentrations of two of the 12 DMD patients, who we refer to as high absorbers, exceeded the target level of 0.2 µM (67 ng/mL) for several hours following dosing. We determined this target level prior to conducting this clinical trial based on the composite results of our preclinical studies in tissue culture, or
in vitro
preclinical studies, and our preclinical studies in live animals, or
in vivo
preclinical studies, which indicated that this plasma concentration leads to an increase of approximately 50% in levels of utrophin protein. The mean plasma concentrations of the remaining ten patients, who we refer to as low absorbers, were less than this target level and similar to the levels achieved by fasted healthy volunteers in our completed Phase 1 clinical trial who had received a single 200 mg/kg dose of ezutromid. Nonetheless, we believe that the patients who did not achieve the target plasma level in the clinical trial may still have achieved a plasma level of ezutromid sufficient to modulate the production of utrophin and possibly result in a clinical benefit. This belief is based in part on the work of Professor Davies’ research group, in which the continued expression of utrophin protein in transgenic lines of an mdx mouse, even at levels just above those in a normal mdx mouse, had a meaningful, positive effect on muscle performance.
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Patients Experienced a Reduction in CK and Other Enzyme Markers of Muscle Damage
. We observed a reduction compared to baseline in the enzymes CK, aspartate aminotransferase, or AST, and alanine aminotransferase, or ALT, in over 90% of the patients in the clinical trial during dosing with ezutromid. Other liver associated enzymes, gamma glutamyl transferase, alkaline phosphatase and albumin, showed no meaningful change from baseline over the same dosing period. The levels of CK, ALT and AST are typically low in healthy people. In DMD patients, however, damage to muscle fibers leads to the release of these enzymes from the muscle and accumulation in the blood. The mean reductions in CK, ALT and AST were statistically significant as compared to the baseline pre-dose levels (p <0.05). We determine statistical significance based on a widely used, conventional statistical method that establishes the p-value of clinical results. Typically, a p-value of 0.05 or less represents statistical significance. Following the end of dosing, the levels of these enzymes increased toward pre-
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a single dose on day one; and
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twice daily doses on days two to fourteen.
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Modified Diet had a Positive Impact on Plasma Absorption
. In this trial, plasma absorption of ezutromid was increased in patients with DMD who followed specific dietary guidance that provided a balanced diet of fats, carbohydrates and proteins. Ten of the 12 patients achieved plasma exposure levels above 30 ng/mL for a mean of 14.0 hours in a 22-hour period on day 14 of the trial, with six of these patients achieving levels above 67 ng/mL for a mean of 8.2 hours in the same 22-hour period on day 14. Plasma levels of 30 ng/mL and 67 ng/mL correlate to an increase in utrophin levels of approximately 30% and 50%, respectively, based on our
in vitro
studies that were undertaken in myoblast cells from patients with DMD and myotubes from healthy individuals. The remaining two patients achieved maximum plasma exposure levels that exceeded 20 ng/mL. We believe that these two patients also achieved plasma exposure that may be sufficient to modulate the production of utrophin protein and possibly result in clinical benefit. The plasma exposure levels described above for all 12 patients were achieved after each received twice daily doses of 2,500 mg of ezutromid.
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Higher Plasma Levels of Ezutromid were Observed on Day 14 Compared to Day 1 in the Majority of Patients
. In this trial, seven of the 12 patients had higher plasma levels when measuring plasma levels over time and calculating the area under the curve, or AUC, on day 14 compared to day 1. This accumulation of drug had not been observed in our previous Phase 1 clinical trial conducted in healthy volunteers or our initial Phase 1b clinical trial conducted in patients with DMD. We expect to evaluate the impact of longer-term dosing of ezutromid on plasma exposure in future clinical trials, including in our Phase 2 PhaseOut DMD clinical trial.
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Treatment with Ezutromid did not Alter CK Levels, an Enzyme Biomarker of Muscle Damage, Compared to Placebo
. We did not observe a change in the levels of the enzyme CK compared to baseline when patients were treated with 1,250 mg or 2,500 mg of ezutromid twice a day for 14 days compared to placebo. In our initial Phase 1b clinical trial, in which there was no placebo control, we observed a statistically significant reduction in CK levels compared to baseline when dosing patients with ezutromid. We believe that the results from our Phase 1b modified diet trial indicate that the reduction in CK levels we observed previously is likely not related to treatment with ezutromid. We plan to evaluate CK levels, as well as additional biomarkers, over a longer duration of exposure to ezutromid in future clinical trials.
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Ezutromid was Well Tolerated.
Ezutromid was well tolerated at all doses tested in this clinical trial, with no serious adverse events reported. All reported adverse events were mild in severity and resolved prior to completion of the study. The most common adverse event was pale stools and this was reported by patients in the placebo group and each of the ezutromid treatment groups. In the opinion of the trial investigator, there were no clinically meaningful changes in physical examination, vital signs and hematology or biochemistry parameters in any of the patients. We also did not observe any issues with patient compliance.
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A twice daily dose of 3,000 mg on days one to three in a fed state;
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A twice daily dose of 6,000 mg on day four in a fed state;
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A single dose of 6,000 mg in the morning on day five in a fasted state; and
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A single dose of 6,000 mg in the evening on day five in a fed state.
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A twice daily dose of 2,000 mg on days one to three in a fed state;
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A twice daily dose of 4,000 mg on day four in a fed state;
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A single dose of 4,000 mg in the morning on day five in a fasted state; and
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A single dose of 4,000 mg in the evening on day five in a fed state.
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250 mg twice a day for seven days;
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500 mg twice a day for seven days; and
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1,000 mg twice a day for seven days.
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Healthy Volunteers Demonstrated Increased Plasma Levels With the F6 Formulation of Ezutromid.
In healthy volunteers, the F6 formulation of ezutromid achieved an over ten-fold increase in plasma levels compared to the F3 formulation of ezutromid. This formulation was selected to progress into Part B of the trial and undergo evaluation in patients with DMD.
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DMD Patients Demonstrated Increased Plasma Levels of Ezutromid with F6 Formulation.
At the 1,000 mg twice a day dose of the F6 formulation of ezutromid, the five evaluable patients achieved an average maximum plasma concentration of 390 ng/mL on day 7, the final day of dosing. By comparison, in our Phase 1b modified diet trial, a twice daily dose of 2,500 mg of the F3 formulation of ezutromid achieved an average maximum plasma concentration of 63 ng/mL on day 14, the final day of dosing. We believe both the F6 and F3 formulations of ezutromid will be able to modulate utrophin. However, we anticipate that only one of these formulations will be chosen to move forward in clinical development, based on the safety and efficacy data from PhaseOut DMD.
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Ezutromid was Generally Well Tolerated.
Ezutromid was generally well tolerated at all doses tested in both the healthy volunteers and DMD patients, except for one DMD patient who exhibited changes in liver parameters and withdrew from the trial, despite showing no clinical symptoms. The finding was classified as a serious adverse event.
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Screening and Baseline Stage
: A screening and baseline phase lasts up to 28 days for each patient. During this time, we take a number of baseline measurements. These include magnetic resonance spectroscopy / magnetic resonance imaging, or MR, analysis of upper leg muscle, a baseline muscle biopsy from the bicep, blood samples for pharmacokinetic and enzyme biomarker measurements, and baseline measurements for functional tests, including the six minute walk test and the North Star Ambulatory Assessment.
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Treatment Stage
: The treatment phase for each patient lasts a total of 48 weeks. During the treatment stage, an MR analysis will be conducted at 12, 24, 36 and 48 weeks of treatment. Blood samples for pharmacokinetic and enzyme biomarker analysis will be taken at 4, 8, 12, 24, 36 and 48 weeks of treatment. In addition, 24 of the patients are scheduled to have a second muscle biopsy taken at week 24, with the remaining 16 patients are scheduled to have their second biopsy at week 48; As of January 2018, one patient from each of these groups has withdrawn from the trial prior to their second biopsy due to reasons unrelated to ezutromid. Functional tests will be performed at 12, 24, 36 and 48 weeks of treatment.
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Safety and Tolerability Follow-up Stage
: Each patient in the trial will have a 30-day safety and tolerability follow up. For trial patients who do not enroll in the extension phase, the safety and tolerability follow-up will occur after the 48 week treatment phase. Patients enrolling in the extension phase are expected to have a 30-day safety and tolerability follow-up following completion of the extension phase.
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Trial Extension Phase
: At the end of the 48 weeks of dosing, all patients have the option of enrolling into an extension phase and continue to receive ezutromid. We expect that the extension phase will last until ezutromid either receives marketing approval in the relevant country or its development is discontinued. This extension phase will allow us to monitor safety and efficacy data related to longer-term dosing of the F3 and F6 formulations of ezutromid. The decision to include the extension phase followed a review of the safety and tolerability data from PhaseOut DMD by an independent data monitoring committee. A protocol amendment was submitted to the MHRA, U.K. Ethics Committee and the FDA in March 2017 and was subsequently approved, which enables enrollment of patients into the extension phase once they have completed 48 weeks of dosing without a cessation in dosing.
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Additional Cohort:
The amended protocol we submitted to the regulatory authorities and ethics committee to extend the trial also provides for the enrollment into PhaseOut DMD of patients who participated in prior clinical trials of ezutromid but who did not meet the inclusion criteria for PhaseOut DMD. All safety, tolerability and functional data from this arm of the trial will be distinct from analyses of the efficacy portion of PhaseOut DMD.
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Mean Increase in Utrophin Protein Intensity.
We observed an increase in mean utrophin protein intensity levels of 7% in biopsies at 24 weeks compared to baseline (0.370 to 0.396, 95% C.I., -0.005, 0.058). Background levels of utrophin are high in patients with DMD as their muscle fibers undergo a continuous cycle of damage and repair. Utrophin protein is produced during the initial stage of muscle repair, but its production is naturally switched off as muscle fibers mature.
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Reduction in Muscle Damage as Measured by Developmental Myosin.
We observed a statistically significant and meaningful reduction in muscle damage as measured by a 23% decrease in mean developmental myosin in muscle biopsies at 24 weeks compared to baseline (11.37% to 8.76%, 95% C.I., -4.33, -0.90). Developmental myosin is a biomarker of muscle damage and is present in muscle fibers that are repairing. Studies show that there is a correlation between disease severity and levels of developmental myosin present in muscle fibers with higher levels typically found in DMD patients with lower levels found in patients with the milder disease, BMD.
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Reduction in Muscle Inflammation as Measured by Magnetic Resonance Spectroscopy.
We observed a decrease in muscle inflammation as measured by magnetic resonance spectroscopy transverse relaxation time T2, or MRS-T2. We observed a mean decrease from baseline to 24 weeks in the soleus (calf muscle) in patients (n=38) of -0.861 milliseconds that achieved statistical significance (31.850 milliseconds to 30.989 milliseconds, 95% C.I., -1.440, -0.281). We also observed a mean decrease of -0.470 milliseconds in MRS-T2 in the vastus lateralis (thigh muscle) of patients (n=37) from baseline to 24 weeks (32.265 milliseconds to 31.795 milliseconds, 95% C.I., -1.158, 0.218). We believe the decrease in MRS-T2 is independent of any anti-inflammatory effect provided by corticosteroids due to the patients being on stable regimens of such treatments.
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DMD Patients Achieved Plasma Levels of Ezutromid Expected to Modulation Utrophin Protein with F3 and F6 Formulation.
We observed that all patients achieved plasma levels of ezutromid that we believe will be sufficient to modulate the expression of utrophin protein. The responses in utrophin protein intensity, developmental myosin and MRS-T2 were observed in patients treated with either the F3 or the F6 formulations of ezutromid. We did not observe a relationship between drug exposure levels and responses to these pharmacology measures or the safety measures after 24-weeks of treatment with ezutromid.
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A decrease in the mean muscle fiber diameter from 42.1µm at baseline to 40.3µm at 24 weeks as measured by muscle biopsy.
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The mean fat fraction in the vastus lateralis muscle increased from 14.7% at baseline to 18.5% at 24 weeks (n=37) as measured by magnetic resonance spectroscopy. We believe that the potential for change in this magnetic resonance parameter is expected to be observable after longer-term dosing of patients.
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A change in mean six-minute walk distance from 404m at baseline to 395m at 24 weeks (n=39) and a change in mean North Star Ambulatory Assessment score from 25.0 at baseline to 24.4 at 24 weeks (n=39). The North Star Ambulatory Assessment has a maximum score of 40.
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All patients retained ambulation after 24-weeks of treatment (n=39).
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Increased Utrophin Levels in DMD Patient Derived Myoblast Cells
. We dosed
in vitro
muscle derived cells called myoblasts from DMD patients with ezutromid. After three days of dosing, we observed a two-fold mean increase in utrophin protein levels in these myoblast cells as compared to baseline levels.
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Increased Utrophin Protein Expression in Heart, Diaphragm and Other Skeletal Muscles in mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days. Following the 28 days of dosing, we observed increased mean utrophin protein levels in the diaphragm (p<0.05) and the heart (p<0.01) as compared to untreated
mdx
mice. We also observed an increase in utrophin protein levels in the tibialis anterior, or TA, and extensor digitorum longus, or EDL, skeletal muscles. We also observed a mean increase in utrophin messenger ribonucleic acid, or mRNA, which is the precursor to utrophin protein. We believe that the good systemic distribution of drug observed in this experiment is important for DMD therapies that aim to maintain ambulation and prolong life for DMD patients.
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Localized Utrophin Production at the Sarcolemma in mdx Mouse
. In the
mdx
mouse experiment described in the prior bullet, we observed an increase in utrophin protein in the TA and EDL skeletal muscles of
mdx
mice treated with ezutromid compared to untreated
mdx
mice as evidenced by an observable increase in the number of utrophin positive muscle fibers in these muscles. The increase in utrophin protein was localized at the sarcolemma, which is the required site of action for utrophin production in muscle. In a separate study in which we forced
mdx
mice to exercise, we observed a similar increase in utrophin positive muscle fibers in the diaphragm and the TA and EDL muscles, and an increase of utrophin levels within these muscle fibers, of
mdx
mice treated with ezutromid compared to untreated
mdx
mice. We believe that these results are noteworthy because DMD disease pathology is even more pronounced in the diaphragm and hind-limb muscles of the forced exercise
mdx
mice as compared to sedentary
mdx
mice.
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Reduction in Secondary Markers of DMD in mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days. In this study, we observed a mean 75% reduction in CK levels as compared to untreated
mdx
mice after 15 days, which is the time at which muscle degeneration is at a maximum in this model. We continued to observe lower mean CK levels in the treated
mdx
mice group after 28 days, at which point muscle degeneration stabilized. Plasma levels of CK, muscle regeneration, inflammation and fibrosis are secondary markers of DMD. We also observed a reduction in the mean level of muscle fiber regeneration in
mdx
mice treated with ezutromid compared to untreated
mdx
mice as evidenced by a reduction in the number of muscle fibers with centrally localized nuclei, which are biomarkers of regeneration. We believe this resulted from the continual expression of utrophin, which protected the dystrophin deficient muscle fibers, and therefore reduced the amount of muscle regeneration. In addition, following treatment with ezutromid, we observed a mean reduction in overall skeletal muscle inflammation and fibrosis in the
mdx
mice treated with ezutromid compared to untreated
mdx
mice, which indicates a reduction in muscle fiber damage.
|
•
|
Protection of Muscle Function in Forced Exercise mdx Mouse
. We dosed
mdx
mice with ezutromid daily for 28 days and forced the mice to exercise during this treatment period. As illustrated in the figure below, at the end of dosing the forced exercise
mdx
mice treated with ezutromid demonstrated a statistically significant mean increase in protection against exercise-induced forelimb weakness (p<0.05) compared to untreated forced exercise
mdx
mice. We measured forelimb weakness by the force increment required for the
mdx
mice to lose the strength to grip. The
mdx
mice treated with ezutromid exhibited forelimb strength comparable to that observed in the wild type control mice, which unlike
mdx
mice are not dystrophin deficient. The untreated
mdx
mice experienced a mean decrease in forelimb strength by the end of the 28 day study. Forcing the
mdx
mouse to exercise worsens the impact of DMD and we believe more closely approximates the pathology of human DMD patients.
|
•
|
Target Plasma Concentration to Achieve a 50% Increase in Utrophin Levels
. The composite results from our
in vitro
and
in vivo
preclinical studies indicated that a plasma concentration of approximately 0.2 µM (67 ng/mL) leads to an increase of approximately 50% in levels of utrophin protein. These plasma concentration findings formed the basis of the target pharmacokinetic level that we have used in our clinical trials of ezutromid. As noted above, in the experiments performed by Professor Kay Davies, the continued expression of utrophin, even at levels just above those in a normal
mdx
mouse, had a meaningful, positive effect on muscle performance.
|
•
|
quantifying numbers of utrophin positive fibers and distribution of utrophin protein in each fiber from muscle biopsies using immunohistochemistry;
|
•
|
evaluating muscle biopsies to quantify numbers of regenerating fibers; and
|
•
|
developing other serum biomarkers that will quantify muscle damage.
|
•
|
four fasted subjects, randomized for three subjects to receive a single 2 mg dose of ridinilazole and one subject to receive placebo;
|
•
|
four fasted subjects, randomized for three subjects to receive a single 20 mg dose of ridinilazole and one subject to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 100 mg dose of ridinilazole and two subjects to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 400 mg dose of ridinilazole and two subjects to receive placebo;
|
•
|
eight fasted subjects, randomized for six subjects to receive a single 2,000 mg dose of ridinilazole and two subjects to receive placebo; and
|
•
|
eight subjects, randomized for six subjects to receive a single 1,000 mg dose of ridinilazole under fasted conditions and a single 1,000 mg dose under fed conditions, and two subjects to receive two single doses of placebo on the same dosing schedule. The doses under fed and fasted conditions were separated by a minimum of six days.
|
•
|
eight subjects randomized for six subjects to receive 200 mg doses of ridinilazole twice per day for nine days with a single final dose on day ten and two subjects to receive placebo on the same dosing schedule; and
|
•
|
eight subjects randomized for six subjects to receive 500 mg doses of ridinilazole twice per day for nine days with a single final dose on day ten and two subjects to receive placebo on the same dosing schedule.
|
•
|
Ridinilazole was Well Tolerated.
Ridinilazole was well tolerated at all doses tested in the clinical trial. The incidence of adverse events in the clinical trial was low for patients treated with ridinilazole and comparable to the incidence of adverse events for patients receiving placebo. The majority of the adverse events that were considered to be possibly related to ridinilazole were classified as gastrointestinal disorders and were mild in severity and resolved without intervention. One patient withdrew from the clinical trial after suffering from appendicitis on day one. The trial investigator determined this serious adverse event was unlikely to be related to treatment with ridinilazole.
|
•
|
Ridinilazole was Retained in the Gastrointestinal Tract.
Ridinilazole was targeted to the gastrointestinal tract, which is the site where CDI occurs in the body. Systemic exposure was close to or below the level of detection in both fed and fasted subjects.
|
•
|
Ridinilazole was Highly Selective for Total Clostridia Bacteria with Minimal Impact on Other Natural Gut Flora.
We measured levels of bacteria in fecal samples from Part 2 of the clinical trial for gut flora composition on the day prior to commencement of dosing and on days four and nine of drug administration during the clinical trial. As illustrated in the figure below, in both the 200 mg and 500 mg dose cohorts, median levels of key bacteria groups that comprise the natural gut flora remained relatively constant during this period and did not fluctuate substantially from baseline. The one exception was the total clostridia bacterial group. The counts of total clostridia decreased from the
|
•
|
Ridinilazole Demonstrated Statistical Superiority Over Vancomycin.
Our Phase 2 proof of concept trial met its primary endpoint with ridinilazole achieving a SCR rate of 66.7% compared to 42.4% for vancomycin (non-inferiority margin of 15%, p=0.0004). This represented statistical superiority of ridinilazole over vancomycin using the pre-specified 90% confidence interval. The primary analysis was conducted on the modified intent-to-treat, or mITT, population (36 patients dosed with ridinilazole, 33 patients dosed with vancomycin) that comprised patients with CDI confirmed by the presence of free toxin in feces. The results of the mITT population were consistent with the intent-to-treat, or ITT, population (50 patients dosed with ridinilazole, 50 patients dosed with vancomycin) and the per protocol, or PP, population (31 patients dosed with ridinilazole, 25 patients dosed with vancomycin). We also observed a generally consistent trend to improved SCR with ridinilazole across subgroups at higher risk of recurrence, including the elderly, patients who were on concomitant antibiotics at the start of treatment and patients with a prior history of CDI.
|
•
|
Ridinilazole Demonstrated a Large Reduction in Rates of Recurrence Compared to Vancomycin.
We observed that the statistical superiority in SCR with ridinilazole compared to vancomycin was driven by a large numerical reduction in rates of disease recurrence. Clinical cure rates at the end of ten days of treatment were similar, with ridinilazole achieving a rate of 77.8% compared to 69.7% for vancomycin, but ridinilazole achieved a recurrence rate of 14.3% compared to 34.8% for vancomycin during the 30-day post-treatment period.
|
•
|
Ridinialzole Preserved the Gut Microbiome.
Stool samples were obtained from 82 patients enrolled in the Phase 2 clinical trial to evaluate the efficacy of ridinilazole compared to vancomycin. These samples were analyzed on study entry, day five and day ten of treatment, day 25 and day 40 post-entry and at the time of any recurrence for five specific bacterial groups associated with a healthy gut microbiome (
Bacteroides
,
Prevotella
,
Enterbactericeae
,
C. coccoides
and
C. leptum
) and also for total bacteria present. We observed that patients treated with vancomycin had a significant decrease (p<0.001) in four of the five bacterial groups (
Bacteroides
,
Prevotella
,
C. coccoides
and
C. leptum
) at day five and day ten, and a significant decrease in total bacteria. Patients treated with ridinilazole did not have a significant decrease in these specific bacterial groups nor the total bacteria. Moreover, we observed the initial evidence of recovery of these key bacterial groups in some patients treated with ridinilazole. We believe that these data provide evidence that ridinilazole is able to preserve a healthy gut microbiome during treatment for CDI and that the recovery of the key bacterial groups contributed to the large numerical reduction in disease recurrence we observed in the trial results.
|
•
|
Ridinilazole was Retained in the Gastrointestinal Tract.
Ridinilazole was targeted to the gastrointestinal tract, which is the site where CDI occurs in the body. Systemic exposure was close to or below the level of detection in patients with CDI, with plasma concentrations very similar to those observed in our Phase 1 clinical trial in healthy volunteers.
|
•
|
Ridinilazole Reduced Biomarkers of Inflammation.
We measured levels of two key markers of inflammation, calprotectin and lactoferrin, in feces collected from the 69 patients who comprised the mITT group. The samples analyzed were collected at the time of randomization (prior to initiation of treatment), at day five and at day ten. We observed that ridinilazole and vancomycin reduced concentrations of calprotectin and lactoferrin by similar levels when analyzing the results for all patients. We also observed that a subset of patients with severe CDI had a greater reduction in levels of calprotectin and lactoferrin when treated with ridinilazole compared to vancomycin. We believe these data indicate that ridinilazole is associated with a greater reduction in inflammatory markers compared to vancomycin in patients with severe CDI.
|
•
|
Ridinilazole was Well Tolerated.
Ridinilazole was generally well tolerated. The overall rate of adverse events and serious adverse events reported in the ridinilazole and vancomycin treatment arms were comparable.
|
•
|
the plasma pharmacokinetics of ridinilazole in patients with CDI;
|
•
|
the qualitative and quantitative effect of ridinilazole and fidaxomicin on gut flora;
|
•
|
the plasma, urine and fecal concentrations of ridinilazole and its metabolites; and
|
•
|
the efficacy of ten days of dosing with ridinilazole compared to fidaxomicin for the treatment of CDI.
|
•
|
Ridinilazole Preserved the Microbiome to a Greater Extent than Fidaxomicin.
We observed that following 10 days of treatment, ridinilazole had markedly less of an impact on the gut microbiome of trial patients by measures of overall diversity and changes in key bacterial families when compared to those trial patients dosed with fidaxomicin. We observed that while ridinilazole and fidaxomicin both reduced the abundance of
C. difficile
, fidaxomicin treated patients had reduced abundance of other bacterial families, including Firmicutes phylum that are thought to have direct functional roles in protecting against CDI. We observed that for a number of these bacterial families, the difference between the two treatments reach statistical significance. We also reported alpha diversity, as measured by the Simpson's Diversity Index, as another measure of microbiome health, We observed a greater reduction in alpha-diversity during fidaxomicin treatment compared with ridinilazole treatment. These measures were a key secondary endpoint of the trial. We believe that these measures provide further evidence of ridinilazole's precision in killing
C. difficile
while preserving the gut microbiome.
|
•
|
Ridinilazole was Well Tolerated.
The primary endpoint of the trial was safety, as measured by the number of treatment emergent adverse events and serious adverse events. During the trial, no new or unexpected safety signals were identified and ridinilazole was well-tolerated.
|
•
|
Comparable Rates of Sustained Clinical Response.
We observed that seven of the 14 ridinilazole treated patients and six of the 13 fidaxomicin treatment patients were cured at the end of treatment and did not have a recurrence of CDI within the following 30 days to achieve a sustained clinical response. The trial was however not designed for efficacy comparisons due to the small number of patients enrolled and so we believe no conclusions on efficacy should be made based solely on this data.
|
•
|
Potency Against C. difficile
. We screened ridinilazole
in vitro
against panels of
C. Difficile
clinical isolates from the United States and the United Kingdom. In these studies, ridinilazole displayed a potent bactericidal effect against all clinical isolates of
C. difficile
, including hypervirulent strains, such as ribotype 027. Ridinilazole was more potent than both vancomycin and metronidazole, and was either equally potent to, or more potent than, fidaxomicin. We have also tested ridinilazole against a panel of
C. difficile
clinical isolates that maximize the diversity of resistance to key classes of commonly used antibiotics. Ridinilazole did not display evidence of cross resistance with other classes of key antibiotics in common use.
|
•
|
Targeted Spectrum of Activity
. We conducted
in vitro
testing of ridinilazole, vancomycin, metronidazole and fidaxomicin against a wide panel of bacteria that are commonly found in the gut flora and are necessary for normal function of the gastrointestinal tract and also have wide implications on human health, such as the proper function of the immune system. As illustrated in the figure below, in this study ridinilazole had a minimal antibiotic effect against these beneficial bacterial groups. Ridinilazole also displayed higher selectivity for
C. difficile
in this study as compared to vancomycin, metronidazole and fidaxomicin and published data for cadazolid, an antibiotic that was reported recently by another company to have missed its primary endpoint of non-inferiority to vancomycin on clinical cure in one Phase 3 clinical trial, but achieved the same primary endpoint in a second Phase 3 clinical trial.
In vitro
potency is measured by determining the concentration of a drug (in micrograms per liter) needed to inhibit the growth of 90% of the bacterial strains being tested, referred to as a MIC
90
measurement. A high number, typically higher than 256, indicates a weak antimicrobial effect, and a low number, typically less than eight, indicates a potent antimicrobial effect. We believe that the targeted spectrum of activity for ridinilazole seen in this study compared to the relatively broad spectrum of activity of other antibiotics indicates the potential for ridinilazole to selectively target
C. difficile
bacteria without causing collateral damage to the gut flora and thereby reduce CDI recurrence rates.
|
•
|
Protection Against CDI Recurrence
. In a hamster model, we infected one group of hamsters with the hypervirulent CDI strain ribotype 027 and a second group of hamsters with a second CDI strain ribotype 012. In the United States, the hypervirulent CDI strain ribotype 027 accounts for approximately one third of all CDI cases. We then treated hamsters from each of the two infected groups with different doses of ridinilazole, vancomycin and fidaxomicin for five days. We evaluated disease recurrence over the 21 days following treatment. In this hamster model, a hamster fatality within the first five days is a result of initial
C.
difficile
infection, while a fatality from day six to day 25 is a result of recurrent disease. As illustrated in the figure below, the hamsters from both infected groups that were treated with two different doses of ridinilazole had survival rates of 90% to 100% against strain ribotype 027 and 80% to 100% against strain ribotype 012. These survival rates were higher than hamsters treated with vancomycin (0% to 10% survival rates) for both CDI strains, comparable to hamsters treated with two different doses of fidaxomicin against strain ribotype 027 (90% to 100% survival rates) and higher than hamsters treated with two different doses of fidaxomicin against strain ribotype 012 (0% to 40% survival rates). All infection control hamsters received placebo and died by the second day following infection.
|
•
|
Inhibition of Sporulation
. In the
in vitro
testing of ridinilazole described above, we treated
C. difficile
cells with different concentrations of ridinilazole and measured the percentage of spores formed 96 hours after treatment. Untreated cells had a 100% conversion rate into
C. difficile
spores, which are the dormant protected form of the bacteria, after 96 hours. In this study, treatment with ridinilazole resulted in a meaningful reduction in spore count compared with untreated cells against all strains of
C. difficile
tested. We believe the reduction in sporulation may benefit rates of recurrent disease as the spores are highly resistant to standard cleaning practices and lead to increased risks of environmental persistence and disease transmission.
|
•
|
Reduction in Toxin and Inflammation Levels
. In an
in vitro
study, Caco-2 cells, a type of cell found in the colon of humans commonly used in studies of intestinal function, were exposed to
C. difficile
and then treated with ridinilazole, metronidazole and vancomycin or were untreated to act as a control. Following treatment with ridinilazole, toxin A levels were reduced by 91%, toxin B was not detected and IL-8 levels were reduced by 74%. Metronidazole and vancomycin had minimal effect on toxin A or B concentrations, and IL-8 concentrations were similar to control. Toxins A and B are produced by
C. difficile
to elicit an inflammatory response, including IL-8 release, which results in the symptoms of the disease including severe diarrhea. We believe that these data indicate that ridinilazole has the potential to reduce the severity of disease symptoms and that it has the potential to be more effective than current treatment options.
|
•
|
Concomitant Antibiotic Use
. In an
in vitro
bacterial culture study, we administered ridinilazole in combination with selected other antibiotics. In this study, concomitant use of antibiotics had neither a synergistic nor an antagonistic effect on the MIC
90
values of ridinilazole against the
C. difficile
strains tested. We believe these results indicate that concomitant use of other antibiotics will not diminish the potency of ridinilazole. We believe this is an important finding because a significant portion of CDI patients receive antibiotic treatment for persistent or new infections.
|
•
|
Low Propensity for Resistance
. In an
in vitro
study, we treated
C. difficile
bacteria with ridinilazole and assessed the number of resistant bacteria at the end of treatment. We repeated this process multiple times, with each cycle referred to as a serial passage. We observed that use of ridinilazole resulted in a low frequency of spontaneous mutation and no resistance after 14 serial passages of treatment. We have also evaluated ridinilazole mutant prevention concentration, or MPC, a measure evaluating the ability of an antibiotic to minimize the development of resistant organisms, against
C. difficile
clinical isolates.
In vitro
results show that ridinilazole has low MPC values against these isolates, providing further evidence supporting ridinilazole’s profile for low resistance development.
|
•
|
Ridinilazole Arrests Cell Division
. In an
in vitro
study, we treated
C. difficile
bacteria with ridinilazole and assessed its effects on killing the bacteria. The study revealed that ridinilazole halts
C. difficile
cell division, characterized by a significant increase in the length of
C. difficile
cells and an absence of division septum formation.
|
•
|
two granted U.S. patents covering the composition of matter of ezutromid and combinations of ezutromid with ancillary therapeutic agents, which are scheduled to expire in 2029 and 2030, respectively;
|
•
|
a granted U.S. patent covering methods of manufacture of ezutromid, which is scheduled to expire in 2029;
|
•
|
a granted U.S. patent covering formulations of ezutromid, which is scheduled to expire in 2033;
|
•
|
a granted European patent covering the composition of matter of ezutromid that cleared the opposition period in April 2015 with no opposition filed against it at the European Patent Office, and which is scheduled to expire in 2027;
|
•
|
a granted European patent covering formulations of ezutromid, which is scheduled to expire in 2033;
|
•
|
a granted European patent covering combinations of ezutromid with ancillary therapeutic agents, which is scheduled to expire in 2028; and
|
•
|
a number of pending patent applications covering formulations of ezutromid, further methods of use of ezutromid and the composition of matter of second generation utrophin modulator candidates.
|
•
|
a granted U.S. patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029;
|
•
|
a corresponding granted European patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029;
|
•
|
a granted U.S. patent covering hydrates of ridinilazole, which is scheduled to expire in 2029;
|
•
|
a granted European divisional patent covering hydrates of ridinilazole and pharmaceutical compositions comprising ridinilazole;
|
•
|
a further granted U.S. patent covering the use of ridinilazole in the treatment of CDI, which is scheduled to expire in 2029; and
|
•
|
two granted U.S. patents, a granted European patent and a pending European divisional application covering second generation agents for the treatment of CDI, which are scheduled to expire in 2031.
|
•
|
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
|
•
|
submission to the FDA of an IND, which must take effect before human clinical trials may begin;
|
•
|
approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with current good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug product for each indication;
|
•
|
preparation and submission to the FDA of a new drug application, or NDA;
|
•
|
review of the product candidate by an FDA advisory committee, where appropriate or if applicable;
|
•
|
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
|
•
|
satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;
|
•
|
payment of user fees and securing FDA approval of the NDA; and
|
•
|
compliance with any post-approval requirements, including Risk Evaluation and Mitigation Strategies, or REMS, where applicable, and any post-approval studies required by the FDA.
|
•
|
restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls;
|
•
|
fines, warning letters or holds on post-approval clinical trials;
|
•
|
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the required patent information has not been filed;
|
•
|
the listed patent has expired;
|
•
|
the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
|
•
|
the listed patent is invalid, unenforceable or will not be infringed by the new product.
|
•
|
the applicant must complete an identified program of studies within a time period specified by the competent authority, the results of which form the basis of a reassessment of the benefit/risk profile;
|
•
|
the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized person; and
|
•
|
the package leaflet and any medical information must draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.
|
•
|
Compliance with the EU’s stringent pharmacovigilance or safety reporting rules must be ensured. These rules can impose post-authorization studies and additional monitoring obligations.
|
•
|
The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU.
|
•
|
The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU Member State laws. Direct-to-consumer advertising of prescription medicines is prohibited across the EU.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
|
•
|
the federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or 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, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to health care matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing ·or covering up a material fact or making any materially false statement in connection with the delivery of or payment for health care benefits, items or services;
|
•
|
the federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the Affordable Care Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the United States Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
|
•
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-government third-party payors, including private insurers.
|
•
|
an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
•
|
expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices;
|
•
|
addressed 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;
|
•
|
expanded the types of entities eligible for the 340B drug discount program;
|
•
|
established the Medicare Part D coverage gap discount program by requiring manufacturers to provide a 50% (and 70% starting January 1, 2019) point-of-sale-discount off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; 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.
|
Name of subsidiary
|
Country of
registration
|
Activity
|
%
holding
|
Summit Therapeutics Inc.
|
USA
|
Research and Development Services
|
100%
|
Summit Corporation Limited
|
England and Wales
|
Dormant
|
100%
|
Summit (Oxford) Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit (Wales) Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit (Cambridge) Limited
|
England and Wales
|
Dormant
|
100%
|
Summit Discovery 1 Limited
|
England and Wales
|
Dormant
|
100%
|
Summit Corporation Employee Benefit Trust Company Limited
|
England and Wales
|
Dormant
|
100%
|
MuOx Limited
|
England and Wales
|
Dormant
|
100%
|
Discuva Limited
|
England and Wales
|
Research and Development
|
100%
|
Summit Infectious Diseases Limited
|
England and Wales
|
Dormant
|
100%
|
Type/Uses
|
|
Location
|
|
Size
|
|
Lease Expiry
|
Executive office
|
|
Oxfordshire, United Kingdom
|
|
6,781 square feet
|
|
February 2027
|
Executive office
|
|
Cambridge, Massachusetts
|
|
1,168 square feet
|
|
Rolling
|
Laboratory and office
|
|
Cambridge, United Kingdom
|
|
8,834 square feet
|
|
December 2021
|
•
|
costs incurred in conducting our preclinical studies and clinical trials through contract research organizations, including preclinical toxicology, pharmacology, formulation and manufacturing work;
|
•
|
employee related expenses, which include salary and benefits, for our research and development staff;
|
•
|
costs associated with our strategic alliance with the University of Oxford; and
|
•
|
facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies.
|
|
Year ended January 31,
|
||||||||||||||
|
2018
|
|
2018
|
|
2017
|
|
2016
|
||||||||
|
(in thousands)
|
||||||||||||||
DMD program
|
$
|
22,646
|
|
|
£
|
15,959
|
|
|
£
|
9,480
|
|
|
£
|
7,526
|
|
CDI program
|
7,996
|
|
|
5,635
|
|
|
4,088
|
|
|
5,567
|
|
||||
Other research and development costs
|
10,467
|
|
|
7,376
|
|
|
5,384
|
|
|
3,763
|
|
||||
Total
|
$
|
41,109
|
|
|
£
|
28,970
|
|
|
£
|
18,952
|
|
|
£
|
16,856
|
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, rate of progress, costs and results of preclinical development, laboratory testing and clinical trials for our future product candidates;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care, and our ability to achieve market acceptance for any of our product candidates that receive marketing approval;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and manufacturing, for any of our product candidates that receive marketing approval and the rate we expand our physical presence; and
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining, enforcing and protecting our intellectual property rights and defending against any intellectual property-related claims.
|
|
|
Year ended January 31,
|
|
Change 2018 vs. 2017
|
|||||||||||
|
|
2018
|
|
2017
|
|
Increase/(Decrease)
|
|||||||||
|
|
(in thousands, except percentages)
|
|||||||||||||
Revenue
|
|
£
|
25,419
|
|
|
£
|
2,304
|
|
|
£
|
23,115
|
|
|
1,003.3
|
%
|
Other operating income
|
|
2,725
|
|
|
72
|
|
|
2,653
|
|
|
3,684.7
|
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|
|||||||
Research and development
|
|
(28,970
|
)
|
|
(18,952
|
)
|
|
10,018
|
|
|
52.9
|
|
|||
General and administration
|
|
(11,999
|
)
|
|
(8,277
|
)
|
|
3,722
|
|
|
45.0
|
|
|||
Operating loss
|
|
(12,825
|
)
|
|
(24,853
|
)
|
|
(12,028
|
)
|
|
(48.4
|
)
|
|||
Finance income
|
|
3,096
|
|
|
8
|
|
|
3,088
|
|
|
38,600.0
|
|
|||
Finance cost
|
|
(1,164
|
)
|
|
(862
|
)
|
|
302
|
|
|
35.0
|
|
|||
Loss before income tax
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(14,814
|
)
|
|
(57.6
|
)
|
|||
Income tax credit
|
|
3,762
|
|
|
4,336
|
|
|
(574
|
)
|
|
(13.2
|
)
|
|||
Loss for the year
|
|
£
|
(7,131
|
)
|
|
£
|
(21,371
|
)
|
|
£
|
(14,240
|
)
|
|
(66.6
|
)%
|
|
|
Year ended January 31,
|
|
Change 2017 vs. 2016
|
|||||||||||
|
|
2017
|
|
2016
|
|
Increase/(Decrease)
|
|||||||||
|
|
(in thousands, except percentages)
|
|||||||||||||
Revenue
|
|
£
|
2,304
|
|
|
£
|
—
|
|
|
£
|
2,304
|
|
|
—
|
|
Other operating income
|
|
72
|
|
|
1,281
|
|
|
(1,209
|
)
|
|
(94.4
|
)%
|
|||
Operating expenses
|
|
|
|
|
|
|
|
|
|||||||
Research and development
|
|
(18,952
|
)
|
|
(16,856
|
)
|
|
2,096
|
|
|
12.4
|
|
|||
General and administration
|
|
(8,277
|
)
|
|
(4,771
|
)
|
|
3,506
|
|
|
73.5
|
|
|||
Operating loss
|
|
(24,853
|
)
|
|
(20,346
|
)
|
|
4,507
|
|
|
22.2
|
|
|||
Finance income
|
|
8
|
|
|
30
|
|
|
(22
|
)
|
|
(73.3
|
)
|
|||
Finance cost
|
|
(862
|
)
|
|
(2,879
|
)
|
|
(2,017
|
)
|
|
(70.1
|
)
|
|||
Loss before income tax
|
|
(25,707
|
)
|
|
(23,195
|
)
|
|
2,512
|
|
|
(10.8
|
)
|
|||
Income tax credit
|
|
4,336
|
|
|
3,058
|
|
|
1,278
|
|
|
41.8
|
|
|||
Loss for the year
|
|
£
|
(21,371
|
)
|
|
£
|
(20,137
|
)
|
|
£
|
1,234
|
|
|
(6.1
|
)%
|
|
|
Year ended January 31,
|
||||||||||||||
|
|
2018
|
|
2018
|
|
2017
|
|
2016
|
||||||||
|
|
(in thousands)
|
||||||||||||||
Net cash (outflow) / inflow from operating activities
|
|
$
|
(20,843
|
)
|
|
£
|
(14,689
|
)
|
|
£
|
12,141
|
|
|
£
|
(17,182
|
)
|
Net cash outflow from investing activities
|
|
(7,439
|
)
|
|
(5,242
|
)
|
|
(80
|
)
|
|
(36
|
)
|
||||
Net cash inflow from financing activities
|
|
19,731
|
|
|
13,905
|
|
|
413
|
|
|
22,136
|
|
||||
Net (decrease) / increase in cash and cash equivalents
|
|
$
|
(8,551
|
)
|
|
£
|
(6,026
|
)
|
|
£
|
12,474
|
|
|
£
|
4,918
|
|
•
|
continue the research and development of the F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
continue the research and development of ridinilazole;
|
•
|
seek to identify and develop additional future product candidates, including through our bacterial genetics-based platform for the discovery and development of new mechanism antibiotics;
|
•
|
seek marketing approvals for any product candidates that successfully complete clinical development;
|
•
|
ultimately establish a sales, marketing and distribution infrastructure in jurisdictions where we have retained commercialization rights and scale up external manufacturing capabilities to commercialize any product candidates for which we receive marketing approval;
|
•
|
acquire or in-license other product candidates and technology;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
hire additional clinical, regulatory and scientific personnel;
|
•
|
expand our physical presence; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
|
•
|
the progress, costs and results of clinical trials of ezutromid for DMD and ridinilazole for CDI;
|
•
|
the scope, progress, costs and results of preclinical development, laboratory testing and clinical trials for our F3 formulation of ezutromid, the F6 formulation of ezutromid and future generation utrophin modulators that we are developing in collaboration with the University of Oxford and Sarepta;
|
•
|
the number and development requirements of other future product candidates that we pursue;
|
•
|
the costs, timing and outcome of regulatory review of ezutromid, ridinilazole and our other future product candidates;
|
•
|
the costs and timing of commercialization activities, including product sales, marketing, distribution and
|
•
|
subject to receipt of marketing approval, revenue received from commercial sales of ezutromid, ridinilazole or any of our other future product candidates;
|
•
|
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims;
|
•
|
the amounts we receive from Sarepta under our license and collaboration agreement, including for the achievement of development, regulatory and sales milestones and royalty payments;
|
•
|
our contract with BARDA and whether BARDA elects to pursue its designated options beyond the base period;
|
•
|
the amounts we receive from Eurofarma under our license and commercialization agreement, including for the achievement of development, commercialization and sales milestones and for product supply transfers;
|
•
|
our ability to establish and maintain collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
•
|
the rate of the expansion of our physical presence; and
|
•
|
the costs of operating as a public company in the United States in addition to in the United Kingdom.
|
|
|
Payments due by period
|
|||||||||||||||||
|
|
Total
|
|
Less than 1
Year
|
|
Between 1 and 3
Years
|
|
Between 3 and 5
Years
|
|
More than 5
Years
|
|||||||||
|
|
(in thousands)
|
|||||||||||||||||
Operating lease obligations
|
|
£
|
1,480
|
|
|
£
|
337
|
|
|
£
|
740
|
|
|
£
|
403
|
|
|
—
|
|
Contractual obligations
|
|
1,673
|
|
|
981
|
|
|
692
|
|
|
—
|
|
|
—
|
|
||||
Total contractual cash obligations
|
|
£
|
3,153
|
|
|
£
|
1,318
|
|
|
£
|
1,432
|
|
|
£
|
403
|
|
|
—
|
|
•
|
an exemption from compliance with the auditor attestation requirement on the effectiveness of our internal controls over financial reporting;
|
•
|
an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
|
•
|
reduced disclosure about the company’s executive compensation arrangements; and
|
•
|
exemptions from the requirements to obtain a non-binding advisory vote on executive compensation or a shareholder approval of any golden parachute arrangements.
|
Name
|
|
Age
|
|
Position
|
Executive Officers
|
|
|
|
|
Glyn Edwards
|
|
62
|
|
Chief Executive Officer, Executive Director
|
Erik Ostrowski
|
|
45
|
|
Chief Financial Officer
|
David Roblin
|
|
51
|
|
Chief Operating Officer, Chief Medical Officer and President of Research and Development
|
Key Employees
|
|
|
|
|
Jonathon Tinsley
|
|
59
|
|
Chief Scientific Officer, DMD
|
Richard Vickers
|
|
42
|
|
Senior Vice President, Anti-Infectives
|
Non-Employee Directors
|
|
|
|
|
Frank Armstrong
(2)(3)(4)
|
|
61
|
|
Non-Executive Chairman
|
Barry Price
(3)(4)
|
|
74
|
|
Non-Executive Director
|
Stephen Davies
(2)(3)(4)
|
|
68
|
|
Non-Executive Director
|
Leopoldo Zambeletti
(1)(3)(4)
|
|
49
|
|
Non-Executive Director
|
Valerie Andrews
(1)(2)(3)(4)
|
|
58
|
|
Non-Executive Director
|
David Wurzer
(1)(3)(4)
|
|
59
|
|
Non-Executive Director
|
|
(1)
|
Member of the Audit Committee.
|
(2)
|
Member of the Remuneration Committee.
|
(3)
|
Member of the Nominating and Corporate Governance Committee.
|
(4)
|
An “independent director” as such term is defined in Rule 10A-3 under the Exchange Act.
|
|
|
Name
|
|
Salary and
Bonus /
Fees
|
|
Taxable
Benefits
(1)
|
|
Pension
Benefit
|
|
Total
|
||||||||||||
Glyn Edwards
|
|
£
|
|
609,000
|
|
|
£
|
|
1,359
|
|
|
£
|
|
18,270
|
|
|
£
|
|
628,629
|
|
Chief Executive Officer and Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Erik Ostrowski
|
|
$
|
|
640,000
|
|
|
|
|
—
|
|
|
$
|
|
17,741
|
|
|
$
|
|
657,741
|
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
David Roblin
|
|
£
|
|
436,442
|
|
|
£
|
|
|
|
£
|
|
14,100
|
|
|
£
|
|
450,542
|
|
|
Chief Operating Officer, Chief Medical Officer and President of Research & Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Frank Armstrong
|
|
£
|
|
75,000
|
|
|
£
|
|
2,804
|
|
|
|
|
—
|
|
|
£
|
|
77,804
|
|
Non-Executive Chairman
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Barry Price
|
|
£
|
|
38,195
|
|
|
£
|
|
2,793
|
|
|
|
|
—
|
|
|
£
|
|
40,988
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stephen Davies
|
|
£
|
|
40,000
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
£
|
|
40,000
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Leopoldo Zambeletti
|
|
£
|
|
36,805
|
|
|
£
|
|
587
|
|
|
|
|
—
|
|
|
£
|
|
37,392
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Valerie Andrews
|
|
£
|
|
58,587
|
|
|
£
|
|
2,108
|
|
|
|
|
—
|
|
|
£
|
|
60,695
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
David Wurzer
|
|
£
|
|
50,978
|
|
|
£
|
|
2,484
|
|
|
|
|
—
|
|
|
£
|
|
53,462
|
|
Non-Executive Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Taxable benefits represent the value of the personal benefits granted, which include private medical insurance and life assurance for executive officers and travel costs (and associated income tax and national insurance contributions which were settled on behalf of the Non-Executive Directors) for attendance at board meetings for the Non-Executive Directors. Amounts included are based on the taxable benefits reported in the year ended
January 31, 2018
to HM Revenue & Customs.
|
Name
|
|
Date of grant
|
|
At February 1, 2017
|
|
Granted
during
the
period
|
|
Lapsed
during
the
period
|
|
At January 31, 2018
|
|
Price
per
share
(£)
|
|
Date from
which
exercisable
|
|
Expiration
date
|
|||||
Glyn Edwards
|
|
May 10, 2012
|
|
150,046
|
|
|
—
|
|
|
—
|
|
|
150,046
|
|
|
0.60
|
|
|
Note 1
|
|
May 10, 2022
|
Chief Executive Officer and Executive Director
|
|
May 10, 2012
|
|
657,500
|
|
|
—
|
|
|
(657,500
|
)
|
|
—
|
|
|
0.60
|
|
|
Note 2
|
|
May 10, 2022
|
January 31, 2013
|
|
72,973
|
|
|
—
|
|
|
—
|
|
|
72,973
|
|
|
0.20
|
|
|
Note 3
|
|
January 31, 2023
|
||
|
December 18, 2013
|
|
76,364
|
|
|
—
|
|
|
—
|
|
|
76,364
|
|
|
0.20
|
|
|
Note 4
|
|
December 18, 2023
|
|
|
|
July 15, 2014
|
|
600,000
|
|
|
—
|
|
|
—
|
|
|
600,000
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
|
|
June 16, 2015
|
|
887,333
|
|
|
—
|
|
|
—
|
|
|
887,333
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
June 23, 2016
|
|
110,576
|
|
|
—
|
|
|
—
|
|
|
110,576
|
|
|
0.01
|
|
|
Note 7
|
|
June 23, 2026
|
|
|
April 11, 2017
|
|
—
|
|
|
762,764
|
|
|
—
|
|
|
762,764
|
|
|
1.85
|
|
|
Note 8
|
|
April 11, 2027
|
|
|
July 18, 2017
|
|
—
|
|
|
135,478
|
|
|
—
|
|
|
135,478
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
October 24, 2017
|
|
—
|
|
|
198,776
|
|
|
—
|
|
|
198,776
|
|
|
1.80
|
|
|
Note 10
|
|
October 24, 2027
|
|
|
|
|
2,554,792
|
|
|
1,097,018
|
|
|
(657,500
|
)
|
|
2,994,310
|
|
|
|
|
|
|
|
|
Erik Ostrowski
|
|
June 23, 2014
|
|
400,000
|
|
|
—
|
|
|
—
|
|
|
400,000
|
|
|
1.48
|
|
|
Note 11
|
|
June 23, 2024
|
Chief Financial Officer
|
|
June 16, 2015
|
|
400,000
|
|
|
—
|
|
|
—
|
|
|
400,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
June 23, 2016
|
|
250,000
|
|
|
—
|
|
|
—
|
|
|
250,000
|
|
|
1.05
|
|
|
Note 12
|
|
June 23, 2026
|
|
|
|
July 18, 2017
|
|
—
|
|
|
68,062
|
|
|
—
|
|
|
68,062
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
October 24, 2017
|
|
—
|
|
|
98,495
|
|
|
—
|
|
|
98,495
|
|
|
1.80
|
|
|
Note 10
|
|
October 24, 2027
|
|
|
|
|
1,050,000
|
|
|
166,557
|
|
|
—
|
|
|
1,216,557
|
|
|
|
|
|
|
|
|
David Roblin
|
|
July 15, 2014
|
|
100,000
|
|
|
—
|
|
|
—
|
|
|
100,000
|
|
|
0.80
|
|
|
Note 5
|
|
July 15, 2024
|
Chief Operating Officer, Chief Medical Officer and President of R&D
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
June 23, 2016
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.05
|
|
|
Note 7
|
|
June 23, 2026
|
|
|
April 11, 2017
|
|
—
|
|
|
324,324
|
|
|
—
|
|
|
324,324
|
|
|
1.85
|
|
|
Note 8
|
|
April 11, 2027
|
|
|
July 18, 2017
|
|
—
|
|
|
164,384
|
|
|
—
|
|
|
164,384
|
|
|
1.83
|
|
|
Note 9
|
|
July 18, 2027
|
|
|
|
|
|
142,500
|
|
|
488,708
|
|
|
—
|
|
|
631,208
|
|
|
|
|
|
|
|
|
Barry Price
|
|
April 7, 2011
|
|
13,981
|
|
|
|
|
|
|
13,981
|
|
|
0.65
|
|
|
Note 13
|
|
April 7, 2021
|
||
Non-Executive Director
|
|
July 15, 2014
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
|
|
56,481
|
|
|
—
|
|
|
—
|
|
|
56,481
|
|
|
|
|
|
|
|
|
Frank Armstrong
|
|
July 15, 2014
|
|
37,500
|
|
|
—
|
|
|
—
|
|
|
37,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
50,000
|
|
|
—
|
|
|
—
|
|
|
50,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
87,500
|
|
|
—
|
|
|
—
|
|
|
87,500
|
|
|
|
|
|
|
|
||
Stephen Davies
|
|
July 15, 2014
|
|
17,500
|
|
|
—
|
|
|
—
|
|
|
17,500
|
|
|
1.26
|
|
|
Note 5
|
|
July 15, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
42,500
|
|
|
—
|
|
|
—
|
|
|
42,500
|
|
|
|
|
|
|
|
||
Leopoldo Zambeletti
|
|
June 23, 2014
|
|
25,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|
1.48
|
|
|
Note 14
|
|
June 23, 2024
|
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
50,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
25,000
|
|
|
|
|
|
|
|
||
Valerie Andrews
Non-Executive Director
|
|
December 23, 2014
|
|
25,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
—
|
|
|
1.37
|
|
|
Note 15
|
|
December 23, 2024
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
|
50,000
|
|
|
—
|
|
|
(25,000
|
)
|
|
25,000
|
|
|
|
|
|
|
|
||
David Wurzer
Non-Executive Director
|
|
June 16, 2015
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
1.43
|
|
|
Note 6
|
|
June 16, 2025
|
|
|
|
25,000
|
|
|
—
|
|
|
—
|
|
|
25,000
|
|
|
|
|
|
|
|
Name
|
|
Date of grant
|
|
At February 1, 2017
|
|
Granted
during
the
period
|
|
Lapsed
during
the
period
|
|
At January 31, 2018
|
|
Price
per
share
(£)
|
|
Date from
which
exercisable
|
|
Expiration
date
|
|||||
Barry Price
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Frank Armstrong
|
|
June 18, 2017
|
|
—
|
|
|
41,096
|
|
|
—
|
|
|
41,096
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
41,666
|
|
|
—
|
|
|
41,666
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
82,762
|
|
|
—
|
|
|
82,762
|
|
|
|
|
|
|
|
||
Stephen Davies
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Leopoldo Zambeletti
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
Valerie Andrews
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
||
David Wurzer
|
|
June 18, 2017
|
|
—
|
|
|
19,179
|
|
|
—
|
|
|
19,179
|
|
|
0.01
|
|
|
Note 16
|
|
December 31, 2018
|
Non-Executive Director
|
|
October 24, 2017
|
|
—
|
|
|
19,444
|
|
|
—
|
|
|
19,444
|
|
|
0.01
|
|
|
Note 17
|
|
December 31, 2018
|
|
|
|
—
|
|
|
38,623
|
|
|
—
|
|
|
38,623
|
|
|
|
|
|
|
|
1.
|
These options became exercisable on May 10, 2015 due to the satisfaction of the performance conditions relating to the share price. In order to vest in full, the average closing share price needed to be equal to or greater than £2.20 for the two months preceding the third anniversary of the date of the grant, 25% would vest where the average closing share price was £1.40 and pro-rated where the average closing share price was between £1.41 and £2.19. The options lapsed if the performance condition relating to our average closing share price was not met by the third anniversary of the date of grant. On measurement, 150,046 options have vested and 77,454 options have lapsed. No options were exercised in the year
.
|
2.
|
These options were split into four tranches with varying performance conditions and would only vest if the average closing share price had been equal to or greater than the specified condition in any period of 60 consecutive calendar days, ending on or before the fifth anniversary of the date of grant. Details of the tranches are as follows: 207,500 with a performance condition based on an average closing share price of £4.00; 200,000 with a performance condition based on an average closing share price of £6.00; 150,000 with a performance condition based on an average closing share price of £8.00; and 100,000 with a performance condition based on an average closing share price of £10.00. The options lapsed as the performance conditions were not met by the fifth anniversary of the date of grant
.
|
3.
|
These deferred bonus options vested and became exercisable on July 31, 2013. These options were awarded as a bonus for the financial year ended January 31, 2013
.
|
4.
|
These deferred bonus options vested and became exercisable on June 18, 2014. These options were awarded as a bonus for the financial year ended January 31, 2014 representing 70% of Mr. Glyn Edwards’ gross basic salary for that financial year
.
|
5.
|
These options vested on March 13, 2017 as the average closing share price was equal to or greater than £1.89 in a period of 30 consecutive days during the period from the date of the grant to the third anniversary of the date of the grant. One third of the options became exercisable on March 13, 2017, following the second anniversary of the date of grant and the remaining options became exercisable on July 15, 2017, the third anniversary of the date of grant
.
|
6.
|
These options vest if the average closing share price is equal to or greater than £2.145 in any period of 30 consecutive days during the period from the date of the grant to June 16, 2018. Once vested, a third of the options can be exercised on or after June 16, 2017 and all of the options, if vested, can be exercised on or after June 16, 2018. These options will lapse if the performance condition is not met by June 16, 2018
.
In April 2018, all Non-Executive Directors surrendered these awards.
|
7.
|
T
hese deferred bonus options vested and became exercisable on July 21, 2016. These options were awarded in part settlement of the bonus for the financial year ended January 31, 2016 representing 50% of Mr. Glyn Edwards’ gross basic salary for that financial year
.
|
8.
|
These options achieved the performance conditions during the financial year pertaining to corporate and program development milestones. Accordingly, these options will vest in full on June 23, 2019
.
|
9.
|
These options are subject to achievement of performance conditions pertaining to corporate and program development milestones. These options will vest in full on the third anniversary of the date of grant
.
|
10.
|
These options are subject to achievement of performance conditions pertaining to corporate and program development milestones. These options will vest in full on the third anniversary of the date of grant
.
|
11.
|
These options vest and become exercisable in the following proportions, assuming the average closing share price of our ordinary shares on AIM during the two months prior to each relevant vesting date is £2.213 or higher: 25% on the second anniversary of the date of grant, 75% on the third anniversary of the date of grant and 100% on the fourth anniversary of the date of grant. These options will lapse if the performance condition is not met by the fourth anniversary of the date of grant.
|
12.
|
These options will vest in full on June 23, 2019 subject to achievement of performance conditions pertaining to certain corporate and program development milestones. These options will lapse in full if the performance conditions are not met by June 23, 2019.
|
•
|
appointing, approving the compensation of, and assessing the independence, objectivity and effectiveness of our registered public accounting firm;
|
•
|
overseeing the work of our independent registered public accounting firm, including through the receipt and consideration of reports from that firm;
|
•
|
monitoring the integrity of our financial statements by reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and related disclosures;
|
•
|
reviewing and monitoring our internal control over financial reporting, disclosure controls and procedures and code of business conduct;
|
•
|
reviewing and monitoring the effectiveness of our internal audit function;
|
•
|
overseeing our risk assessment and risk management policies;
|
•
|
establishing policies regarding procedures for the receipt and retention of accounting related complaints and concerns;
|
•
|
meeting independently with our internal auditing staff, if any, our independent registered public accounting firm and management; and
|
•
|
reviewing and approving or ratifying any related person transactions.
|
•
|
reviewing and approving, or making recommendations to our board of directors with respect to, the compensation of our directors and executive management;
|
•
|
overseeing an evaluation of our executive management; and
|
•
|
overseeing and administering our employee share option scheme or equity incentive plans in operation from time to time.
|
•
|
identifying individuals qualified to become members of our board;
|
•
|
recommending to our board the persons to be nominated for election as directors and to each of our board’s committees;
|
•
|
overseeing a periodic evaluation of our board;
|
•
|
reviewing and making recommendations to our board with respect to our board leadership structure;
|
•
|
reviewing and making recommendations to our board with respect to management succession planning; and
|
•
|
developing and recommending to our board corporate governance principles.
|
|
|
2018
|
|
2017
|
|
2016
|
|||
By Geography
|
|
|
|
|
|
|
|||
United Kingdom
|
|
54
|
|
|
28
|
|
|
25
|
|
North America
|
|
22
|
|
|
12
|
|
|
12
|
|
Total
|
|
76
|
|
|
40
|
|
|
37
|
|
|
|
2018
|
|
2017
|
|
2016
|
|||
By Function
|
|
|
|
|
|
|
|||
Research & Development
|
|
52
|
|
|
24
|
|
|
22
|
|
General & Administrative
|
|
24
|
|
|
16
|
|
|
15
|
|
Total
|
|
76
|
|
|
40
|
|
|
37
|
|
•
|
each of the members of our board of directors;
|
•
|
each of our other executive officers; and
|
•
|
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our ordinary shares.
|
|
|
Ordinary shares
beneficially owned
|
||||
Name of beneficial owner
|
|
Shares
|
|
%
|
||
Executive officers and directors
|
|
|
|
|
||
Glyn Edwards
(1)
|
|
1,243,292
|
|
|
1.50
|
%
|
Erik Ostrowski
|
|
—
|
|
|
—
|
|
David Roblin
(2)
|
|
107,770
|
|
|
*
|
|
Frank Armstrong
(3)
|
|
51,942
|
|
|
*
|
|
Barry Price
(4)
|
|
107,211
|
|
|
*
|
|
Stephen Davies
(5)
|
|
602,481
|
|
|
*
|
|
Leopoldo Zambeletti
|
|
—
|
|
|
—
|
|
Valerie Andrews
|
|
10,500
|
|
|
*
|
|
David Wurzer
|
|
7,500
|
|
|
*
|
|
All executive officers and directors as a group (9 persons)
(6)
|
|
2,130,696
|
|
|
2.56
|
%
|
5% shareholders
|
|
|
|
|
||
Lansdowne Partners (UK) LLP
(7)
|
|
21,143,500
|
|
|
25.82
|
%
|
Robert Keith
(8)
|
|
4,294,816
|
|
|
5.24
|
%
|
*
|
Less than one percent.
|
(1)
|
Consists of (a) 1,009,959 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 233,333 ordinary shares.
|
(2)
|
Consists of 107,770 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date.
|
(3)
|
Consists of (a) 37,500 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 14,442 ordinary shares.
|
(4)
|
Consists of (a) 31,481 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 75,730 ordinary shares.
|
(5)
|
Consists of (a) 17,500 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 584,981 ordinary shares.
|
(6)
|
Consists of (a) 1,204,210 ordinary shares underlying options that are exercisable as of April 1, 2018 or will become exercisable within 60 days after such date and (b) 926,486 ordinary shares.
|
(7)
|
These shares are registered in the name of HSBC Client Holdings Nominee (UK) Limited. Lansdowne Partners (UK) LLP may be deemed to have voting and dispositive power over the ordinary shares. Investment decisions with respect to the ordinary shares held by Lansdowne Partners (UK) LLP can be made by Stuart Roden, Peter Davies and Jonathan Regis. The address of Lansdowne Partners (UK) LLP is 15 Davies Street, London, W1K 3AG.
|
(8)
|
This information is based on information contained in a TR-1 Notification sent to us on January 25, 2017 by Robert Keith.
|
|
|
Price Per Ordinary Share
|
|
Price Per Ordinary Share
|
||||||||
|
|
£
|
|
$
|
||||||||
|
|
High
|
|
Low
|
|
High
|
|
Low
|
||||
Annual (Fiscal Year Ended January 31):
|
|
|
|
|
|
|
|
|
||||
2014
|
|
3.90
|
|
|
0.78
|
|
|
5.53
|
|
|
1.11
|
|
2015
|
|
2.20
|
|
|
1.04
|
|
|
3.12
|
|
|
1.48
|
|
2016
|
|
1.84
|
|
|
1.17
|
|
|
2.61
|
|
|
1.66
|
|
2017
|
|
2.53
|
|
|
0.91
|
|
|
3.59
|
|
|
1.29
|
|
2018
|
|
2.43
|
|
|
1.43
|
|
|
3.45
|
|
|
2.03
|
|
Quarterly:
|
|
|
|
|
|
|
|
|
||||
First Quarter 2017
|
|
1.33
|
|
|
0.94
|
|
|
1.89
|
|
|
1.33
|
|
Second Quarter 2017
|
|
1.26
|
|
|
1.00
|
|
|
1.88
|
|
|
1.42
|
|
Third Quarter 2017
|
|
2.53
|
|
|
0.91
|
|
|
2.59
|
|
|
1.29
|
|
Fourth Quarter 2017
|
|
1.95
|
|
|
1.43
|
|
|
2.77
|
|
|
2.03
|
|
First Quarter 2018
|
|
2.20
|
|
|
1.75
|
|
|
3.12
|
|
|
2.48
|
|
Second Quarter 2018
|
|
2.03
|
|
|
1.73
|
|
|
2.88
|
|
|
2.45
|
|
Third Quarter 2018
|
|
2.43
|
|
|
1.53
|
|
|
3.45
|
|
|
2.17
|
|
Fourth Quarter 2018
|
|
2.15
|
|
|
1.43
|
|
|
3.05
|
|
|
2.03
|
|
Monthly:
|
|
|
|
|
|
|
|
|
||||
October 2017
|
|
1.98
|
|
|
1.53
|
|
|
2.81
|
|
|
2.17
|
|
November 2017
|
|
1.80
|
|
|
1.43
|
|
|
2.55
|
|
|
2.03
|
|
December 2017
|
|
1.80
|
|
|
1.63
|
|
|
2.55
|
|
|
2.41
|
|
January 2018
|
|
2.15
|
|
|
1.65
|
|
|
3.05
|
|
|
2.34
|
|
February 2018
|
|
1.98
|
|
|
1.63
|
|
|
2.81
|
|
|
2.31
|
|
March 2018
|
|
1.95
|
|
|
1.70
|
|
|
2.77
|
|
|
2.41
|
|
April 2018 (through April 6, 2018)
|
|
1.90
|
|
|
1.75
|
|
|
2.70
|
|
|
2.48
|
|
|
|
Price Per ADS
|
||||
|
|
$
|
||||
|
|
High
|
|
Low
|
||
Annual (Fiscal Year Ended January 31):
|
|
|
|
|
||
2016
|
|
13.68
|
|
|
8.25
|
|
2017
|
|
14.35
|
|
|
5.50
|
|
2018
|
|
16.00
|
|
|
9.05
|
|
Quarterly:
|
|
|
|
|
||
First Quarter 2017
|
|
10.97
|
|
|
6.35
|
|
Second Quarter 2017
|
|
9.84
|
|
|
7.00
|
|
Third Quarter 2017
|
|
14.35
|
|
|
5.50
|
|
Fourth Quarter 2017
|
|
12.08
|
|
|
8.12
|
|
First Quarter 2018
|
|
13.28
|
|
|
10.36
|
|
Second Quarter 2018
|
|
13.98
|
|
|
10.53
|
|
Third Quarter 2018
|
|
16.00
|
|
|
9.73
|
|
Fourth Quarter 2018
|
|
14.77
|
|
|
9.05
|
|
Monthly:
|
|
|
|
|
||
|
|
|
|
|
||
October 2017
|
|
12.79
|
|
|
9.73
|
|
November 2017
|
|
11.96
|
|
|
9.05
|
|
December 2017
|
|
12.02
|
|
|
9.89
|
|
January 2018
|
|
14.77
|
|
|
11.08
|
|
February 2018
|
|
13.64
|
|
|
10.60
|
|
March 2018
|
|
13.90
|
|
|
11.36
|
|
April 2018 (through April 6, 2018)
|
|
13.11
|
|
|
11.84
|
|
•
|
this summary only applies to an absolute beneficial owner of ordinary share or ADS and any dividend paid in respect of the ordinary share where the dividend is regarded for U.K. tax purposes as that person’s own income (and not the income of some other person); and
|
•
|
this summary: (a) only addresses the principal U.K. tax consequences for an investor who holds ordinary share or ADS as a capital asset, (b) does not address the tax consequences that may be relevant to certain special classes of investor such as a dealer, broker or trader in shares or securities and any other person who holds ordinary share or ADS otherwise than as an investment, (c) does not address the tax consequences for a holder that is a financial institution, insurance company, collective investment scheme, pension scheme, charity or tax-exempt organization, (d) assumes that a holder is not an officer or employee of the company (nor of any related company) and has not (and is not deemed to have) acquired the ordinary share or ADS by virtue of an office or employment, and (e) assumes that a holder does not control or hold (and is not deemed to control or hold), either alone or together with one or more associated or connected persons, directly or indirectly (including through the holding of an ADS), an interest of 10% or more in the issued share capital (or in any class thereof), voting power, rights to profits or capital of the company, and is not otherwise connected with the company.
|
•
|
banks or other financial institutions;
|
•
|
insurance companies;
|
•
|
brokers, dealers or traders in securities, currencies, or notional principal contracts;
|
•
|
grantor trusts;
|
•
|
tax-exempt entities, including an “individual retirement account” or “Roth IRA” retirement plan;
|
•
|
regulated investment companies or real estate investment trusts;
|
•
|
persons that hold the ordinary shares as part of a hedge, straddle, conversion, constructive sale or similar transaction involving more than one position;
|
•
|
persons required to accelerate the recognition of any item of gross income with respect to the ADSs as a result of such income being recognized on an applicable financial statement
|
•
|
an entity classified as a partnership and persons that hold the ordinary shares through partnerships or certain other pass-through entities;
|
•
|
holders (whether individuals, corporations or partnerships) that are treated as expatriates for some or all U.S. federal income tax purposes;
|
•
|
persons who acquired the ADSs as compensation for the performance of services;
|
•
|
persons who are resident, or ordinarily resident, in a foreign country;
|
•
|
persons holding the ADSs in connection with a trade or business conducted outside of the United States;
|
•
|
a U.S. holder who holds the ADSs through a financial account at a foreign financial institution that does not meet the requirements for avoiding withholding with respect to certain payments under Sections 1471 through 1474 of the Internal Revenue Code of 1986, as amended, or the Code;
|
•
|
holders that own (or are deemed to own) 10% or more of our voting shares; and
|
•
|
holders that have a “functional currency” other than the U.S. dollar.
|
•
|
an individual who is either a citizen or a tax resident of the United States;
|
•
|
a corporation, or other entity that is treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States or any state of the United States or the District of Columbia;
|
•
|
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
|
•
|
a trust, if a court within the United States is able to exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of the substantial decisions of such trust or has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a United States person.
|
Persons depositing or withdrawing shares or ADS
holders must pay:
|
|
For:
|
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
|
|
Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
|
|
|
|
$.05 (or less) per ADS
|
|
Any cash distribution to ADS holders
|
|
|
|
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs
|
|
Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders
|
|
|
|
$.05 (or less) per ADS per calendar year
|
|
Depositary services
|
|
|
|
Registration or transfer fees
|
|
Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares
|
|
|
|
Expenses of the depositary
|
|
Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
Converting foreign currency to U.S. dollars
|
|
|
|
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes
|
|
As necessary
|
|
|
|
Any charges incurred by the depositary or its agents for servicing the deposited securities
|
|
As necessary
|
|
|
Year Ended January 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands)
|
||||||
Audit Fees
|
|
£
|
341
|
|
|
£
|
230
|
|
Audit-Related Fees
(1)
|
|
118
|
|
|
166
|
|
||
Tax Fees
(2)
|
|
23
|
|
|
62
|
|
||
All Other Fees
(3)
|
|
—
|
|
|
—
|
|
||
Total
|
|
£
|
482
|
|
|
£
|
458
|
|
(1)
|
For the year ended January 31, 2018, audit-related fees includes assurance reporting in connection with our underwritten public offering in September 2017. These amounts were recognized directly in share premium. For the year ended January 31, 2017, audit-related fees includes assurance reporting in connection with our registration statement on Form F-3 that was originally filed with the U.S. Securities and Exchange Commission on May 12, 2016.
|
(2)
|
Fees relate to the aggregated fees for services rendered on tax compliance, tax advice and tax planning.
|
(3)
|
No fees incurred in this category.
|
•
|
We do not follow Nasdaq’s quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under U.K. law. In accordance with generally accepted business practice, our articles of association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
|
•
|
We do not follow Nasdaq’s requirements that non-management directors meet on a regular basis without management present. Our board of directors may choose to meet in executive session at their discretion.
|
•
|
We do not follow Nasdaq’s requirements to seek shareholder approval for the implementation of certain equity compensation plans, the issuances of ordinary shares under such plans, or in connection with certain private placements of equity securities. In accordance with U.K. law, we are not required to seek shareholder approval to allot ordinary shares in connection with applicable employee equity compensation plans. We will follow U.K. law with respect to any requirement to obtain shareholder approval prior to any private placements of equity securities.
|
Exhibit No.
|
|
Description
|
|
|
|
|
Articles of Association of Summit Therapeutics plc (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Specimen certificate evidencing ordinary shares of Summit Therapeutics plc (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Form of Deposit Agreement among Summit Therapeutics plc, The Bank of New York Mellon, as depositary, and all Owners and Holders of ADSs issued thereunder (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Form of American Depositary Receipt (included in Exhibit 2.2) (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Warrant Instrument, dated April 4, 2012, creating warrant to subscribe for shares in Summit Therapeutics plc issued to Singer Capital Markets Limited (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Warrant Instrument, dated November 22, 2013, relating to Warrants in Registered Form to Subscribe for Ordinary Shares in Summit Therapeutics plc (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
4.1
†
|
|
Grant Agreement, entered into as of December 15, 2011, by and between Duchenne Partners Fund and Summit Therapeutics plc (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.2
†
|
|
MDA Venture Philanthropy Grant Contract, entered into as of December 15, 2011, by and between Muscular Dystrophy Association, Inc. and Summit Therapeutics plc (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.3
†
|
|
Translation Award Funding Agreement, entered into as of October 19, 2012, by and between the Wellcome Trust Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 27, 2015)
|
|
|
|
4.4
†
|
|
Agreement for the Sponsorship of a Research Programme, dated November 22, 2013, by and between The Chancellor Masters and Scholars of the University of Oxford; Isis Innovation Limited; and Summit Therapeutics plc (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.5
†
|
|
Deed of License of Know-How, dated November 22, 2013, by and between Isis Innovation Limited and MuOx Limited (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.6
†
|
|
Supplemental Variation Deed, dated July 24, 2014, by and between Isis Innovation Limited and MuOx Limited (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.7
†
|
|
Option Agreement, dated November 22, 2013, by and between The Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
4.8
†
|
|
Variation Agreement, dated July 16, 2014, by and between The Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
Lease, dated June 21, 2013, by and between MEPC Milton Park No. 1 Limited and MEPC Milton Park No. 2 Limited on behalf of MEPC Milton LP and Summit Therapeutics plc (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
|
Service Agreement, effective as of January 14, 2015, by and between Cambridge Innovation Center and Summit Therapeutics Inc. (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
2005 Enterprise Management Incentive Scheme (incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated November 20, 2014, by and between Summit Therapeutics Inc. and Valerie Andrews (incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated November 21, 2012, by and between Summit Therapeutics plc and Frank Armstrong (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated December 19, 2013, by and between Summit Therapeutics plc and Stephen Davies (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated August 8, 2013, by and between Summit Therapeutics plc and Barry Price (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated April 16, 2014, by and between Summit Therapeutics plc and Leopoldo Zambeletti (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), filed with the Securities and Exchange Commission on January 30, 2015)
|
|
|
|
|
|
Letter of Appointment, dated February 18, 2015, by and between Summit Therapeutics plc and David Wurzer (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Form of Deed of Indemnity (incorporated by reference to Exhibit 10.18 to the Company’s Registration Statement on Form F-1 (File No. 333-201807), as amended, filed with the Securities and Exchange Commission on February 20, 2015)
|
|
|
|
|
|
Deed of Variation, dated November 16, 2015, relating to the Warrant Instrument, dated November 22, 2013 (incorporated by reference to Exhibit 4.19 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
4.20
†
|
|
Variation Agreement, dated November 16, 2015, relating to the Option Agreement, dated November 22, 2013, by and between the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.20 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
4.21
†
|
|
Second Variation Agreement, dated November 16, 2015, relating to the Agreement for the Sponsorship of a Research Programme, dated November 22, 2013, by and between the Chancellor Masters and Scholars of the University of Oxford, Isis Innovation Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.21 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
2016 Long Term Incentive Plan (incorporated by reference to Exhibit 4.22 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on May 12, 2016)
|
|
|
|
|
4.23
†
|
|
License and Collaboration Agreement, dated October 3, 2016, by and between Summit (Oxford) Ltd. and Sarepta Therapeutics, Inc. (incorporated by reference to Exhibit 4.23 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
4.24
†
|
|
Deed of Novation and Variation, dated March 3, 2017, among MuOx Limited, Oxford University Innovation Limited (formerly Isis Innovation Limited) and Summit (Oxford) Limited (incorporated by reference to Exhibit 4.24 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
|
Lease, dated February 17, 2017, by and among MEPC Milton Park No. 1 Limited, MEPC Milton Park No. 2 Limited and Summit Therapeutics plc (incorporated by reference to Exhibit 4.25 to the Company’s Annual Report on Form 20-F (File No. 001-36866), filed with the Securities and Exchange Commission on March 30, 2017)
|
|
|
|
|
4.26
*+
|
|
Agreement, dated September 5, 2017, by and between Summit (Oxford) Limited and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)
|
|
|
|
Exhibit No.
|
|
Description
|
|
|
|
4.27
*+
|
|
License and Commercialization Agreement, dated December 18, 2017, by and between Summit (Oxford) Ltd. and Eurofarma Laboratórios S.A.
|
|
|
|
4.28
*+
|
|
Share Purchase Agreement, dated December 23, 2017, by and among Summit Therapeutics plc and the shareholders of Discuva Limited (1)
|
|
|
|
4.29
*+
|
|
Transfer Incentive Agreement, dated December 23, 2017, by and among Discuva Limited and certain of its managers.
|
|
|
|
4.30
*+
|
|
Third Variation Agreement, dated September 20, 2017, by and among the Chancellor Masters and Scholars of the University of Oxford, Oxford University Innovation Limited and Summit Therapeutics plc
|
|
|
|
4.31
*
|
|
Lease, dated December 22, 2017, by and between Merrifield Centre Ltd and Discuva Limited
|
|
|
|
4.32
*+
|
|
Equity and Revenue Sharing Agreement, dated October 16, 2017, by and between Summit (Oxford) Limited and the Wellcome Trust Limited
|
|
|
|
4.33
*
|
|
Form of Non-Executive Director Restricted Stock Unit (RSU) Agreement
|
|
|
|
8.1
*
|
|
Subsidiaries of Summit Therapeutics plc
|
|
|
|
12.1
*
|
|
Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
12.2
*
|
|
Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
13.1
*
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
15.1
*
|
|
Consent of PricewaterhouseCoopers LLP
|
|
|
|
101.INS
*
|
|
XBRL Instance Document
|
|
|
|
101.SCH
*
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
*
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
*
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
*
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE
*
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
*
|
|
Filed herewith.
|
†
|
|
Confidential treatment has been granted as to certain portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
+
|
|
Confidential treatment has been requested as to certain portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
(1)
|
|
The schedules and exhibits to the Share Purchase Agreement have been omitted. A copy of any omitted schedule or exhibit will be furnished to the Securities and Exchange Commission upon request.
|
SUMMIT THERAPEUTICS PLC
|
||
|
|
|
By:
|
|
/s/ Glyn Edwards
|
Name:
Title:
|
|
Glyn Edwards
Chief Executive Officer
|
|
|
Note
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
|
|
|
£000
|
|
£000
|
||
ASSETS
|
|
|
|
|
|
|
||
Non-current assets
|
|
|
|
|
|
|
||
Goodwill
|
|
12
|
|
2,478
|
|
|
664
|
|
Intangible assets
|
|
13
|
|
14,785
|
|
|
3,470
|
|
Property, plant and equipment
|
|
14
|
|
809
|
|
|
116
|
|
|
|
|
|
18,072
|
|
|
4,250
|
|
Current assets
|
|
|
|
|
|
|
||
Prepayments and other receivables
|
|
15
|
|
11,134
|
|
|
1,027
|
|
Current tax receivable
|
|
|
|
4,654
|
|
|
4,248
|
|
Cash and cash equivalents
|
|
|
|
20,102
|
|
|
28,062
|
|
|
|
|
|
35,890
|
|
|
33,337
|
|
Total assets
|
|
|
|
53,962
|
|
|
37,587
|
|
LIABILITIES
|
|
|
|
|
|
|
||
Non-current liabilities
|
|
|
|
|
|
|
||
Deferred revenue
|
|
17
|
|
(18,033
|
)
|
|
(23,615
|
)
|
Financial liabilities on funding arrangements
|
|
18
|
|
(3,090
|
)
|
|
(5,919
|
)
|
Provisions for other liabilities and charges
|
|
20
|
|
(1,641
|
)
|
|
(85
|
)
|
Deferred tax liability
|
|
21
|
|
(2,379
|
)
|
|
(565
|
)
|
|
|
|
|
(25,143
|
)
|
|
(30,184
|
)
|
Current liabilities
|
|
|
|
|
|
|
||
Trade and other payables
|
|
16
|
|
(8,932
|
)
|
|
(3,984
|
)
|
Deferred revenue
|
|
17
|
|
(10,012
|
)
|
|
(6,912
|
)
|
|
|
|
|
(18,944
|
)
|
|
(10,896
|
)
|
Total liabilities
|
|
|
|
(44,087
|
)
|
|
(41,080
|
)
|
Net assets / (liabilities)
|
|
|
|
9,875
|
|
|
(3,493
|
)
|
EQUITY
|
|
|
|
|
|
|
||
Share capital
|
|
22
|
|
736
|
|
|
618
|
|
Share premium account
|
|
|
|
60,237
|
|
|
46,420
|
|
Share-based payment reserve
|
|
|
|
6,743
|
|
|
5,136
|
|
Merger reserve
|
|
|
|
3,027
|
|
|
(1,943
|
)
|
Special reserve
|
|
|
|
19,993
|
|
|
19,993
|
|
Currency translation reserve
|
|
|
|
37
|
|
|
50
|
|
Accumulated losses reserve
|
|
|
|
(80,898
|
)
|
|
(73,767
|
)
|
Total equity / (deficit)
|
|
|
|
9,875
|
|
|
(3,493
|
)
|
|
|
Note
|
|
Year ended January 31, 2018
|
|
|
Year ended January 31, 2017
|
|
|
Year ended January 31, 2016
|
|
|||
|
|
|
|
£000
|
|
|
£000
|
|
|
£000
|
|
|||
Revenue
|
|
5
|
|
25,419
|
|
|
|
2,304
|
|
|
|
—
|
|
|
Other operating income
|
|
7
|
|
2,725
|
|
|
|
72
|
|
|
|
1,281
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
7
|
|
(28,970
|
)
|
|
|
(18,952
|
)
|
|
|
(16,856
|
)
|
|
General and administration
|
|
7
|
|
(11,999
|
)
|
|
|
(8,277
|
)
|
|
|
(4,771
|
)
|
|
Total operating expenses
|
|
|
|
(40,969
|
)
|
|
|
(27,229
|
)
|
|
|
(21,627
|
)
|
|
Operating loss
|
|
|
|
(12,825
|
)
|
|
|
(24,853
|
)
|
|
|
(20,346
|
)
|
|
Finance income
|
|
9
|
|
3,096
|
|
|
|
8
|
|
|
|
30
|
|
|
Finance cost
|
|
9
|
|
(1,164
|
)
|
|
|
(862
|
)
|
|
|
(2,879
|
)
|
|
Loss before income tax
|
|
|
|
(10,893
|
)
|
|
|
(25,707
|
)
|
|
|
(23,195
|
)
|
|
Income tax
|
|
10
|
|
3,762
|
|
|
|
4,336
|
|
|
|
3,058
|
|
|
Loss for the year
|
|
|
|
(7,131
|
)
|
|
|
(21,371
|
)
|
|
|
(20,137
|
)
|
|
Other comprehensive (loss) / income
|
|
|
|
|
|
|
|
|
|
|
|
|||
Items that may be reclassified subsequently to profit or loss
|
|
|
|
|
|
|
|
|
|
|
|
|||
Exchange differences on translating foreign operations
|
|
|
|
(13
|
)
|
|
|
29
|
|
|
|
(41
|
)
|
|
Total comprehensive loss
|
|
|
|
(7,144
|
)
|
|
|
(21,342
|
)
|
|
|
(20,178
|
)
|
|
Basic and diluted earnings per Ordinary Share from operations
|
|
11
|
|
(11
|
)
|
p
|
|
(35
|
)
|
p
|
|
(34
|
)
|
p
|
|
|
Note
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
|
|
£000s
|
|
£000s
|
|
£000s
|
|||
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|||
Loss before income tax
|
|
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
|
|
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
Adjusted for:
|
|
|
|
|
|
|
|
|
|||
Other operating income on derecognition of financial liabilities on funding
arrangements
|
|
18
|
|
(908
|
)
|
|
—
|
|
|
—
|
|
Finance income
|
|
9
|
|
(3,096
|
)
|
|
(8
|
)
|
|
(30
|
)
|
Finance cost
|
|
9
|
|
1,164
|
|
|
862
|
|
|
2,879
|
|
Foreign exchange loss / (gain)
|
|
|
|
1,960
|
|
|
711
|
|
|
(169
|
)
|
Depreciation
|
|
14
|
|
140
|
|
|
48
|
|
|
38
|
|
Amortization of intangible fixed assets
|
|
13
|
|
106
|
|
|
10
|
|
|
10
|
|
Loss on disposal of assets
|
|
13,14
|
|
40
|
|
|
—
|
|
|
—
|
|
Movement in provisions
|
|
20
|
|
(60
|
)
|
|
12
|
|
|
28
|
|
Research and development expenditure credit
|
|
7
|
|
(23
|
)
|
|
(3
|
)
|
|
(44
|
)
|
Share-based payment
|
|
6
|
|
1,607
|
|
|
1,379
|
|
|
1,160
|
|
Adjusted loss from operations before changes in working capital
|
|
|
|
(9,963
|
)
|
|
(22,696
|
)
|
|
(19,323
|
)
|
(Increase) / decrease in prepayments and other receivables
|
|
|
|
(8,993
|
)
|
|
492
|
|
|
1,106
|
|
(Decrease) / increase in deferred
revenue
|
|
|
|
(2,482
|
)
|
|
30,527
|
|
|
—
|
|
Increase / (decrease) in trade and other payables
|
|
|
|
3,375
|
|
|
813
|
|
|
(366
|
)
|
Cash (used by) / generated from operations
|
|
|
|
(18,063
|
)
|
|
9,136
|
|
|
(18,583
|
)
|
Taxation received
|
|
|
|
3,374
|
|
|
3,005
|
|
|
1,401
|
|
Net cash (used by) / generated from operating activities
|
|
|
|
(14,689
|
)
|
|
12,141
|
|
|
(17,182
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
|||
Acquisition of subsidiaries net of cash acquired
|
|
27
|
|
(4,775
|
)
|
|
—
|
|
|
—
|
|
Purchase of property, plant and equipment
|
|
|
|
(360
|
)
|
|
(81
|
)
|
|
(66
|
)
|
Purchase of intangible assets
|
|
|
|
(119
|
)
|
|
(7
|
)
|
|
—
|
|
Interest received
|
|
|
|
12
|
|
|
8
|
|
|
30
|
|
Net cash used in investing activities
|
|
|
|
(5,242
|
)
|
|
(80
|
)
|
|
(36
|
)
|
Financing activities
|
|
|
|
|
|
|
|
|
|||
Proceeds from issue of share capital
|
|
|
|
14,931
|
|
|
—
|
|
|
26,101
|
|
Transaction costs on share capital issued
|
|
|
|
(1,428
|
)
|
|
—
|
|
|
(4,187
|
)
|
Proceeds from exercise of warrants
|
|
|
|
10
|
|
|
107
|
|
|
—
|
|
Proceeds from exercise of share options
|
|
|
|
392
|
|
|
283
|
|
|
222
|
|
Cash received from funding arrangements accounted for as financial liabilities
|
|
18
|
|
—
|
|
|
23
|
|
|
—
|
|
Net cash generated from financing activities
|
|
|
|
13,905
|
|
|
413
|
|
|
22,136
|
|
(Decrease) / increase in cash and cash equivalents
|
|
|
|
(6,026
|
)
|
|
12,474
|
|
|
4,918
|
|
Effect of exchange rates on cash and cash equivalents
|
|
|
|
(1,934
|
)
|
|
(716
|
)
|
|
121
|
|
Cash and cash equivalents at beginning of the year
|
|
|
|
28,062
|
|
|
16,304
|
|
|
11,265
|
|
Cash and cash equivalents at end of the year
|
|
|
|
20,102
|
|
|
28,062
|
|
|
16,304
|
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2017
|
|
618
|
|
|
46,420
|
|
|
5,136
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
50
|
|
|
(73,767
|
)
|
|
(3,493
|
)
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,131
|
)
|
|
(7,131
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
|
|
|
(13
|
)
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
(7,131
|
)
|
|
(7,144
|
)
|
New share capital issued
|
|
84
|
|
|
14,847
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,931
|
|
Transaction costs on share capital issued
|
|
—
|
|
|
(1,428
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,428
|
)
|
Issue of ordinary shares as consideration for a business combination
|
|
30
|
|
|
—
|
|
|
—
|
|
|
4,970
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,000
|
|
New share capital issued from exercise of warrants
|
|
1
|
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10
|
|
Share options exercised
|
|
3
|
|
|
389
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
392
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,607
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,607
|
|
At January 31, 2018
|
|
736
|
|
|
60,237
|
|
|
6,743
|
|
|
3,027
|
|
|
19,993
|
|
|
37
|
|
|
(80,898
|
)
|
|
9,875
|
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2016
|
|
613
|
|
|
46,035
|
|
|
3,757
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
21
|
|
|
(52,396
|
)
|
|
16,080
|
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21,371
|
)
|
|
(21,371
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29
|
|
|
—
|
|
|
29
|
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
29
|
|
|
(21,371
|
)
|
|
(21,342
|
)
|
New share capital issued from exercise of warrants
|
|
2
|
|
|
105
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
107
|
|
Share options exercised
|
|
3
|
|
|
280
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
283
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,379
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,379
|
|
At January 31, 2017
|
|
618
|
|
|
46,420
|
|
|
5,136
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
50
|
|
|
(73,767
|
)
|
|
(3,493
|
)
|
|
|
Share
capital
|
|
Share
premium
account
|
|
Share-
based
payment
reserve
|
|
Merger
reserve
|
|
Special
reserve
|
|
Currency
translation
reserve
|
|
Accumulated
losses
reserve
|
|
Total
Equity
|
||||||||
Group
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
|
£000s
|
||||||||
At February 1, 2015
|
|
411
|
|
|
24,101
|
|
|
2,597
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
62
|
|
|
(32,259
|
)
|
|
12,962
|
|
Loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,137
|
)
|
|
(20,137
|
)
|
Currency translation adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41
|
)
|
|
|
|
|
(41
|
)
|
Total comprehensive loss for the year
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41
|
)
|
|
(20,137
|
)
|
|
(20,178
|
)
|
New share capital issued
|
|
198
|
|
|
25,903
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
26,101
|
|
Transaction costs on share capital issued
|
|
—
|
|
|
(4,187
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,187
|
)
|
Share options exercised
|
|
4
|
|
|
218
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
222
|
|
Share-based payment
|
|
—
|
|
|
—
|
|
|
1,160
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,160
|
|
At January 31, 2016
|
|
613
|
|
|
46,035
|
|
|
3,757
|
|
|
(1,943
|
)
|
|
19,993
|
|
|
21
|
|
|
(52,396
|
)
|
|
16,080
|
|
1.
|
Basis of accounting (continued)
|
All patents (once filed)
|
Over the period of the relevant patents (assumed to be 20 years)
|
Option over non-financial assets
|
Over the period of the relevant agreement
|
1.
|
Basis of accounting (continued)
|
Leasehold improvements
|
Over the period of the remaining lease
|
Laboratory equipment
|
3-10 years
|
Office and IT equipment
|
3-5 years
|
1.
|
Basis of accounting (continued)
|
•
|
the initial recognition of goodwill;
|
•
|
the initial recognition of an asset or liability in a transaction which is not a business combination and at the time of the transaction affects neither accounting or taxable profit; and
|
•
|
investments in subsidiaries and jointly controlled entities where the Group is able to control the timing of the reversal of the difference, and it is probable that the difference will not reverse in the foreseeable future.
|
International Accounting Standards (IAS/IFRS)
|
|
Effective Date
|
Amendments resulting from Annual Improvements 2014–2016 Cycle (clarifying scope)
|
|
January 1, 2017
|
Amendment to IAS 7, Disclosure Initiative
|
|
January 1, 2017
|
Amendment to IAS 12, Recognition of Deferred Tax Assets for Unrealised Losses
|
|
January 1, 2017
|
International Accounting Standards (IAS/IFRS)
|
|
Effective Date
|
IFRS 9, Financial Instruments (as revised in 2014)
|
|
January 1, 2018
|
IFRS 15, Revenue from Contracts with Customers
|
|
January 1, 2018
|
Amendment to IFRS 2 Share Based Payments, Classification and Measurement of Share-based Payment Transactions
|
|
January 1, 2018
|
Amendments resulting from Annual Improvements 2014–2016 Cycle
|
|
January 1, 2018
|
IFRIC 22 Foreign Currency Transactions and Advance Consideration
|
|
January 1, 2018
|
IFRS 16, Leases
|
|
January 1, 2019
|
Amendments to IFRS 3 Business Combinations, Remeasurement of previously held interest
|
|
January 1, 2019
|
Amendments to IAS 12 Income Taxes, Income tax consequences of dividends
|
|
January 1, 2019
|
Amendments to IAS 19 Employee Benefits, Plan amendments, curtailments or settlements
|
|
January 1, 2019
|
Amendments to IAS 23 Borrowing Costs, Borrowing costs eligible for capitalisation
|
|
January 1, 2019
|
Amendments resulting from Annual Improvements 2015–2017 Cycle
|
|
January 1, 2019
|
IFRIC 23 Uncertainty over Income Tax Treatments
|
|
January 1, 2019
|
Amendment to IFRS 10 and IAS 28, Sale or Contribution of Assets between an Investor and its Associate or Joint Venture
|
|
To be determined
|
|
Year ended January 31, 2018
|
|
|
£000
|
|
Estimated decrease in revenue by category:
|
|
|
Licensing agreements
|
13,059
|
|
Research collaboration agreement
|
—
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of revenue by category:
|
|
|
|
|
|
|
|||
Licensing agreements
|
|
25,109
|
|
|
2,304
|
|
|
—
|
|
Research collaboration agreement
|
|
310
|
|
|
—
|
|
|
—
|
|
|
|
25,419
|
|
|
2,304
|
|
|
—
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of revenue by geography:
|
|
|
|
|
|
|
|||
United States
|
|
25,067
|
|
|
2,304
|
|
|
—
|
|
Latin America
|
|
42
|
|
|
—
|
|
|
—
|
|
Europe
|
|
310
|
|
|
—
|
|
|
—
|
|
|
|
25,419
|
|
|
2,304
|
|
|
—
|
|
|
|
January 31, 2018
|
|
January 31, 2017
|
|
January 31, 2016
|
|||
Technical, research and development
|
|
34
|
|
|
23
|
|
|
19
|
|
Corporate and administration
|
|
26
|
|
|
21
|
|
|
18
|
|
|
|
60
|
|
|
44
|
|
|
37
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Wages and salaries
|
|
7,493
|
|
|
5,932
|
|
|
3,876
|
|
Social security costs
|
|
643
|
|
|
434
|
|
|
247
|
|
Other pension costs
|
|
350
|
|
|
332
|
|
|
90
|
|
Share-based payment
|
|
1,607
|
|
|
1,379
|
|
|
1,160
|
|
|
|
10,093
|
|
|
8,077
|
|
|
5,373
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Short-term employee benefits
|
|
|
|
|
|
|
|||
Wages and salaries
|
|
1,520
|
|
|
1,252
|
|
|
934
|
|
Social security costs
|
|
162
|
|
|
98
|
|
|
58
|
|
|
|
1,682
|
|
|
1,350
|
|
|
992
|
|
Post-employment benefits
|
|
|
|
|
|
|
|||
Amounts paid in lieu of employer pension contributions
|
|
32
|
|
|
17
|
|
|
17
|
|
Other pension costs
|
|
14
|
|
|
11
|
|
|
—
|
|
|
|
46
|
|
|
28
|
|
|
17
|
|
Share-based payment
|
|
705
|
|
|
327
|
|
|
626
|
|
Total remuneration
|
|
2,433
|
|
|
1,705
|
|
|
1,635
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Other operating income
|
|
|
|
|
|
|
|||
Income recognized in respect of BARDA
|
|
1,772
|
|
|
—
|
|
|
—
|
|
Income on derecognition of the Wellcome Trust financial liability
|
|
908
|
|
|
—
|
|
|
—
|
|
Income recognized in respect of the Wellcome Trust
|
|
—
|
|
|
13
|
|
|
592
|
|
Grant income
|
|
13
|
|
|
56
|
|
|
645
|
|
Research and development credit
|
|
23
|
|
|
3
|
|
|
44
|
|
Other income
|
|
9
|
|
|
—
|
|
|
—
|
|
|
|
2,725
|
|
|
72
|
|
|
1,281
|
|
Research and development
|
|
|
|
|
|
|
|||
Employee benefit expense
|
|
5,616
|
|
|
4,218
|
|
|
2,848
|
|
Share-based payment expense
|
|
327
|
|
|
374
|
|
|
356
|
|
Program related costs
|
|
21,810
|
|
|
13,605
|
|
|
13,093
|
|
Amortization of intangible assets
|
|
105
|
|
|
10
|
|
|
10
|
|
Other research and development costs
|
|
1,112
|
|
|
745
|
|
|
549
|
|
|
|
28,970
|
|
|
18,952
|
|
|
16,856
|
|
General and administration
|
|
|
|
|
|
|
|||
Employee benefit expense
|
|
2,870
|
|
|
2,480
|
|
|
1,365
|
|
Share-based payment expense
|
|
1,280
|
|
|
1,005
|
|
|
804
|
|
Foreign exchange loss
|
|
1,986
|
|
|
533
|
|
|
(501
|
)
|
Depreciation of property, plant and equipment
|
|
141
|
|
|
48
|
|
|
38
|
|
Loss on disposal of assets
|
|
42
|
|
|
—
|
|
|
—
|
|
Operating lease rentals
|
|
289
|
|
|
213
|
|
|
131
|
|
Other general and administration costs
|
|
5,322
|
|
|
3,998
|
|
|
2,934
|
|
Royalty expense
|
|
69
|
|
|
—
|
|
|
—
|
|
|
|
11,999
|
|
|
8,277
|
|
|
4,771
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Fees payable to the auditors and its associates for the audit of the Company and Consolidated Financial Statements
|
|
132
|
|
|
110
|
|
|
44
|
|
Fees payable to the auditors and its associates for other services:
|
|
|
|
|
|
|
|||
- Audit of the Company’s subsidiaries
(2)
|
|
209
|
|
|
120
|
|
|
71
|
|
- Audit-related assurance services
|
|
—
|
|
|
3
|
|
|
6
|
|
- Other assurance services
(1)
|
|
118
|
|
|
163
|
|
|
158
|
|
- Tax advisory services
|
|
2
|
|
|
15
|
|
|
9
|
|
- Tax compliance services
|
|
21
|
|
|
47
|
|
|
11
|
|
Total fees payable
|
|
482
|
|
|
458
|
|
|
299
|
|
(1)
|
For the year ended January 31, 2018, other assurance services includes assurance reporting on information included in information used for the Company's underwritten public offering completed on 18 September 2017. These amounts were recognized directly in share premium. For the year ended January 31, 2017, other assurance services includes assurance reporting on information included in the Company’s registration statement on Form F-3 that was originally filed with the U.S. Securities and Exchange Commission on May 12, 2016.
|
(2)
|
For the year ended January 31, 2018,
fees payable for the Consolidated Financial Statements and fees payable for the Company's subsidiaries includes audit services relating to the initial audit and business combination accounting for Discuva Limited. These amounts will be non recurring fees.
|
|
Note
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
|
£000
|
|
£000
|
|
£000
|
|||
Finance income
|
|
|
|
|
|
|
|
|||
Derecognition of financial liabilities
|
18
|
|
3,085
|
|
|
—
|
|
|
—
|
|
Interest income on deposits
|
|
|
11
|
|
|
8
|
|
|
30
|
|
Finance income
|
|
|
3,096
|
|
|
8
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|||
Finance costs
|
|
|
|
|
|
|
|
|||
Unwinding of discount factor
|
18
|
|
(754
|
)
|
|
(862
|
)
|
|
(268
|
)
|
Re-measurement of financial liabilities on funding arrangements
|
18
|
|
(410
|
)
|
|
—
|
|
|
(2,611
|
)
|
Finance costs
|
|
|
(1,164
|
)
|
|
(862
|
)
|
|
(2,879
|
)
|
|
|
|
|
|
|
|
|
|||
Net finance income / (costs)
|
|
|
1,932
|
|
|
(854
|
)
|
|
(2,849
|
)
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Analysis of credit in the period
|
|
|
|
|
|
|
|||
Current tax
:
|
|
|
|
|
|
|
|||
Current tax income
|
|
3,767
|
|
|
4,245
|
|
|
2,971
|
|
Adjustments in respect of prior years
|
|
(5
|
)
|
|
(9
|
)
|
|
87
|
|
Total current tax
|
|
3,762
|
|
|
4,236
|
|
|
3,058
|
|
Total deferred tax
|
|
—
|
|
|
100
|
|
|
—
|
|
Total tax
|
|
3,762
|
|
|
4,336
|
|
|
3,058
|
|
|
|
Year ended January 31, 2018
|
|
Year ended January 31, 2017
|
|
Year ended January 31, 2016
|
|||
|
|
£000
|
|
£000
|
|
£000
|
|||
Loss before tax
|
|
(10,893
|
)
|
|
(25,707
|
)
|
|
(23,195
|
)
|
Loss multiplied by the standard rate of corporation tax in the United Kingdom (Current tax) 19.17% (2017: 20%)
|
|
(2,088
|
)
|
|
(5,141
|
)
|
|
(4,678
|
)
|
Change in unrecognized tax losses
|
|
751
|
|
|
2,169
|
|
|
2,691
|
|
Non-deductible expenses
|
|
402
|
|
|
331
|
|
|
184
|
|
Tax relief for qualifying research and development expenditure
|
|
(3,043
|
)
|
|
(1,699
|
)
|
|
(1,170
|
)
|
Prior year adjustments
|
|
5
|
|
|
9
|
|
|
(87
|
)
|
Share options exercised
|
|
(40
|
)
|
|
(84
|
)
|
|
(45
|
)
|
Overseas profits taxed at different rates
|
|
251
|
|
|
179
|
|
|
47
|
|
Change in rate of deferred tax
|
|
—
|
|
|
(100
|
)
|
|
—
|
|
Total tax
|
|
(3,762
|
)
|
|
(4,336
|
)
|
|
(3,058
|
)
|
|
Discuva Limited £000
|
|
MuOx Limited
£000
|
|
Total
£000
|
|||
Cost
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
664
|
|
|
664
|
|
Additions
|
1,814
|
|
|
—
|
|
|
1,814
|
|
At January 31, 2018
|
1,814
|
|
|
664
|
|
|
2,478
|
|
Accumulated impairment
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
—
|
|
|
—
|
|
At January 31, 2018
|
—
|
|
|
—
|
|
|
—
|
|
Net book amount
|
|
|
|
|
|
|||
At February 1, 2017
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2018
|
1,814
|
|
|
664
|
|
|
2,478
|
|
|
Discuva Limited £000
|
|
MuOx Limited
£000
|
|
Total
£000
|
|||
Cost
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2017
|
—
|
|
|
664
|
|
|
664
|
|
Accumulated impairment
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
—
|
|
|
—
|
|
At January 31, 2017
|
—
|
|
|
—
|
|
|
—
|
|
Net book amount
|
|
|
|
|
|
|||
At February 1, 2016
|
—
|
|
|
664
|
|
|
664
|
|
At January 31, 2017
|
—
|
|
|
664
|
|
|
664
|
|
|
Iminosugar
related programs acquired £000 |
|
Utrophin
program acquired £000 |
|
Bacterial genetics-based platform acquired
£000 |
|
Option over non-financial assets
£000 |
|
Other
patents and licenses £000 |
|
Total
£000 |
|||||||
Cost
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
204
|
|
|
4,905
|
|
|
Acquisition of subsidiary (Note 27)
|
—
|
|
|
—
|
|
|
10,670
|
|
|
668
|
|
|
—
|
|
|
11,338
|
|
|
Additions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
119
|
|
|
119
|
|
|
Disposals
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(58
|
)
|
|
(1,438
|
)
|
|
At January 31, 2018
|
—
|
|
|
3,321
|
|
|
10,670
|
|
|
668
|
|
|
265
|
|
—
|
|
14,924
|
|
Accumulated amortization
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(55
|
)
|
—
|
|
(1,435
|
)
|
Charge for the year
|
—
|
|
|
—
|
|
|
(79
|
)
|
|
(4
|
)
|
|
(23
|
)
|
|
(106
|
)
|
|
Disposals
|
1,380
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
1,402
|
|
|
At January 31, 2018
|
—
|
|
|
—
|
|
|
(79
|
)
|
|
(4
|
)
|
|
(56
|
)
|
—
|
|
(139
|
)
|
Net book amount
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2017
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
149
|
|
|
3,470
|
|
|
At January 31, 2018
|
—
|
|
|
3,321
|
|
|
10,591
|
|
|
664
|
|
|
209
|
|
|
14,785
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
Iminosugar
related programs acquired £000 |
|
Utrophin
program acquired £000 |
|
Bacterial genetics-based platform acquired
£000 |
|
Option over non-financial assets
£000 |
|
Other
patents and licenses £000 |
|
Total
£000 |
|||||||
Cost
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
197
|
|
|
4,898
|
|
|
Additions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7
|
|
|
7
|
|
|
At January 31, 2017
|
1,380
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
204
|
|
|
4,905
|
|
|
Accumulated amortization
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(45
|
)
|
|
(1,425
|
)
|
|
Charge for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
(10
|
)
|
|
At January 31, 2017
|
(1,380
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(55
|
)
|
|
(1,435
|
)
|
|
Net book amount
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
At February 1, 2016
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
3,473
|
|
|
At January 31, 2017
|
—
|
|
|
3,321
|
|
|
—
|
|
|
—
|
|
|
149
|
|
|
3,470
|
|
•
|
expected research and development costs based on management’s past experience and knowledge;
|
•
|
probabilities of achieving development milestones based on industry standards;
|
•
|
reported disease prevalence;
|
•
|
expected discovery pipeline;
|
•
|
expected market share based on management’s estimates;
|
•
|
drug reimbursement, costs of goods and marketing estimates; and
|
•
|
expected patent life.
|
Cost
|
Leasehold
improvements
£000
|
|
Laboratory
equipment
£000
|
|
Office and IT
equipment
£000
|
|
Total
£000
|
||||
At February 1, 2017
|
9
|
|
|
19
|
|
|
284
|
|
|
312
|
|
Acquisition of subsidiary (Note 27)
|
—
|
|
|
280
|
|
|
49
|
|
|
329
|
|
Additions
|
340
|
|
|
—
|
|
|
173
|
|
|
513
|
|
Disposals
|
(9
|
)
|
|
|
|
|
(14
|
)
|
|
(23
|
)
|
Revaluation
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
(6
|
)
|
At January 31, 2018
|
340
|
|
|
299
|
|
|
486
|
|
|
1,125
|
|
Accumulated depreciation
|
|
|
|
|
|
|
|
||||
At February 1, 2017
|
(9
|
)
|
|
(17
|
)
|
|
(170
|
)
|
|
(196
|
)
|
Charge for the year
|
(31
|
)
|
|
(19
|
)
|
|
(90
|
)
|
|
(140
|
)
|
Disposals
|
9
|
|
|
—
|
|
|
10
|
|
|
19
|
|
Revaluation
|
—
|
|
|
—
|
|
|
1
|
|
|
1
|
|
At January 31, 2018
|
(31
|
)
|
|
(36
|
)
|
|
(249
|
)
|
|
(316
|
)
|
Net book value
|
|
|
|
|
|
|
|
||||
At February 1, 2017
|
—
|
|
|
2
|
|
|
114
|
|
|
116
|
|
At January 31, 2018
|
309
|
|
|
263
|
|
|
237
|
|
|
809
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
||||
Cost
|
Leasehold
improvements
£000
|
|
Laboratory
equipment
£000
|
|
Office and IT
equipment
£000
|
|
Total
£000
|
||||
At February 1, 2016
|
9
|
|
|
137
|
|
|
228
|
|
|
374
|
|
Additions
|
—
|
|
|
—
|
|
|
81
|
|
|
81
|
|
Disposals
|
—
|
|
|
(118
|
)
|
|
(25
|
)
|
|
(143
|
)
|
At January 31, 2017
|
9
|
|
|
19
|
|
|
284
|
|
|
312
|
|
Accumulated depreciation
|
|
|
|
|
|
|
|
||||
At February 1, 2016
|
(7
|
)
|
|
(135
|
)
|
|
(149
|
)
|
|
(291
|
)
|
Charge for the year
|
(2
|
)
|
|
—
|
|
|
(46
|
)
|
|
(48
|
)
|
Disposals
|
—
|
|
|
118
|
|
|
25
|
|
|
143
|
|
At January 31, 2017
|
(9
|
)
|
|
(17
|
)
|
|
(170
|
)
|
|
(196
|
)
|
Net book value
|
|
|
|
|
|
|
|
||||
At February 1, 2016
|
2
|
|
|
2
|
|
|
79
|
|
|
83
|
|
At January 31, 2017
|
—
|
|
|
2
|
|
|
114
|
|
|
116
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Other receivables
|
3,600
|
|
|
342
|
|
Prepayments
|
6,498
|
|
|
685
|
|
Accrued income
|
1,036
|
|
|
—
|
|
|
11,134
|
|
|
1,027
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Trade payables
|
4,414
|
|
|
906
|
|
Other taxes and social security
|
164
|
|
|
94
|
|
Accruals
|
4,078
|
|
|
2,884
|
|
Other creditors
|
276
|
|
|
100
|
|
|
8,932
|
|
|
3,984
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Due within one year
|
10,012
|
|
|
6,912
|
|
Due more than one year
|
18,033
|
|
|
23,615
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
At February 1
|
5,919
|
|
|
5,034
|
|
Unwinding of discount factor
|
754
|
|
|
862
|
|
Derecognition of financial liabilities – Finance income
|
(3,085
|
)
|
|
—
|
|
Re-measurement of financial liabilities on funding arrangements
|
410
|
|
|
—
|
|
Net finance income / (costs) on funding arrangements accounting for as financial liabilities
|
(1,921
|
)
|
|
862
|
|
Derecognition of financial liabilities – Other operating income
|
(908
|
)
|
|
—
|
|
Cash received from funding arrangements accounted for as financial liabilities
|
—
|
|
|
23
|
|
At January 31
|
3,090
|
|
|
5,919
|
|
|
January 31, 2018
|
|
|
£000
|
|
Estimated financial liabilities on funding arrangements
|
3,090
|
|
1% lower discount rate
|
3,354
|
|
1% higher discount rate
|
2,850
|
|
10% lower revenue assumptions
|
2,818
|
|
10% higher revenue assumptions
|
3,362
|
|
10% lower probability of success
|
1,005
|
|
10% higher probability of success
|
5,123
|
|
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
Note
|
|
£000
|
|
£000
|
||
Loans and receivables
|
|
|
|
|
|
||
Other receivables
(1)
|
15
|
|
3,600
|
|
|
342
|
|
Cash and cash equivalents
|
|
|
20,102
|
|
|
28,062
|
|
|
|
|
23,702
|
|
|
28,404
|
|
Financial liabilities measured at amortized cost
|
|
|
|
|
|
||
Trade and other payables
|
16
|
|
8,932
|
|
|
3,984
|
|
Financial liabilities on funding arrangements
|
18
|
|
3,090
|
|
|
5,919
|
|
|
|
|
12,022
|
|
|
9,903
|
|
(1)
|
Prepayments and accrued income have been excluded as they are not considered to be a financial instrument.
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Cash at bank and in hand
|
|
|
|
||
Pounds Sterling
|
5,535
|
|
|
8,969
|
|
US Dollar
|
14,567
|
|
|
19,093
|
|
|
20,102
|
|
|
28,062
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
On current account
|
20,102
|
|
|
28,062
|
|
|
20,102
|
|
|
28,062
|
|
Year ended January 31, 2018
|
(1)%
|
|
Actual
|
|
1%
|
|||
Interest rate
|
—
|
|
|
0.02
|
|
|
1.02
|
|
Interest received (£000)
|
—
|
|
|
5
|
|
|
246
|
|
Year ended January 31, 2017
|
(1)%
|
|
Actual
|
|
1%
|
|||
Interest rate
|
—
|
|
|
0.04
|
|
|
1.04
|
|
Interest received (£000)
|
—
|
|
|
8
|
|
|
230
|
|
|
Assumed contingent liabilities £000s
|
|
Dilapidations £000s
|
|
Royalties £000s
|
|
Total
£000s |
||||
At February 1, 2017
|
—
|
|
|
85
|
|
|
—
|
|
|
85
|
|
Additions
|
1,466
|
|
|
150
|
|
|
25
|
|
|
1,641
|
|
Used during the year
|
—
|
|
|
(85
|
)
|
|
—
|
|
|
(85
|
)
|
At January 31, 2018
|
1,466
|
|
|
150
|
|
|
25
|
|
|
1,641
|
|
|
Assumed contingent liabilities £000s
|
|
Dilapidations £000s
|
|
Royalties £000s
|
|
Total
£000s |
||||
At February 1, 2016
|
—
|
|
|
73
|
|
|
—
|
|
|
73
|
|
Additions
|
—
|
|
|
12
|
|
|
—
|
|
|
12
|
|
Used during the year
|
—
|
|
|
|
|
|
—
|
|
|
—
|
|
At January 31, 2017
|
—
|
|
|
85
|
|
|
—
|
|
|
85
|
|
|
January 31, 2018
|
|
|
£000
|
|
Estimated assumed contingent liabilities
|
1,466
|
|
1% lower discount rate
|
1,579
|
|
1% higher discount rate
|
1,368
|
|
10% lower probability of success
|
1,208
|
|
10% higher probability of success
|
1,705
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Amounts falling due after more than one year
|
|
|
|
||
At February 1
|
565
|
|
|
664
|
|
Acquisition of subsidiary (Note 27)
|
1,814
|
|
|
—
|
|
Credited to the income statement
|
—
|
|
|
(99
|
)
|
At January 31
|
2,379
|
|
|
565
|
|
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Allotted, called up and fully paid
|
|
|
|
||
73,563,624 (2017: 61,841,566) Ordinary shares of 1p each
|
736
|
|
|
618
|
|
|
736
|
|
|
618
|
|
|
Number of Shares
|
|
Total Nominal Value £000
|
|
Total Share Premium £000
|
|
Total Consideration £000
|
|||
At February 1, 2016
|
61,290,740
|
|
613
|
|
|
46,035
|
|
|
46,648
|
|
New share capital issued from exercise of warrants
|
177,045
|
|
2
|
|
|
105
|
|
|
107
|
|
Share options exercised
|
373,781
|
|
3
|
|
|
280
|
|
|
283
|
|
At January 31, 2017
|
61,841,566
|
|
618
|
|
|
46,420
|
|
|
47,038
|
|
|
|
|
|
|
|
|
|
|||
At February 1, 2017
|
61,841,566
|
|
618
|
|
|
46,420
|
|
|
47,038
|
|
New share capital issued (net of transaction costs)
|
8,389,250
|
|
84
|
|
|
13,419
|
|
|
13,503
|
|
Issue of Ordinary Shares as consideration for a business combination
(1)
|
2,934,272
|
|
30
|
|
|
—
|
|
|
30
|
|
New share capital issued from exercise of warrants
|
50,000
|
|
1
|
|
|
9
|
|
|
10
|
|
Share options exercised
|
348,536
|
|
3
|
|
|
389
|
|
|
392
|
|
At January 31, 2018
|
73,563,624
|
|
736
|
|
|
60,237
|
|
|
60,973
|
|
(1)
|
The difference between the nominal value of the share capital acquired in Discuva Limited and fair value of shares issued in the business combination using the acquisition method of accounting was
recognized as part of the Group's merger reserve arising as a result of certain requirements in the United Kingdom.
|
Date
|
Number of
options exercised
|
|
April 10, 2017
|
16,667
|
|
June 27, 2017
|
19,425
|
|
September 28, 2017
|
32,500
|
|
September 29, 2017
|
94,425
|
|
October 2, 2017
|
97,199
|
|
October 4, 2017
|
88,320
|
|
|
348,536
|
|
Date of grant
|
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
Approved EMI scheme
|
|
|
|
|
|
|
|
|
||
April 7, 2011
|
|
0.65
|
|
|
5,873
|
|
|
April 8, 2014
|
|
April 7, 2021
|
May 10, 2012
|
|
0.60
|
|
|
150,046
|
|
|
May 10, 2014
|
|
May 10, 2022
|
December 24, 2012
|
|
0.85
|
|
|
21,500
|
|
|
December 24, 2015
|
|
December 24, 2022
|
January 31, 2013
|
|
0.20
|
|
|
72,973
|
|
|
July 31, 2013
|
|
January 31, 2023
|
July 15, 2014
|
|
1.26
|
|
|
249,621
|
|
|
July 15, 2016
|
|
July 15, 2024
|
January 21, 2015
|
|
1.23
|
|
|
25,000
|
|
|
January 21, 2017
|
|
January 21, 2025
|
June 23, 2016
|
|
1.05
|
|
|
560,343
|
|
|
June 23, 2017
|
|
June 23, 2026
|
|
|
|
|
1,085,356
|
|
|
|
|
|
Date of grant
|
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
Unapproved scheme
|
|
|
|
|
|
|
|
|
||
April 7, 2011
|
|
0.65
|
|
|
13,981
|
|
|
April 8, 2014
|
|
April 8, 2021
|
December 18, 2013
|
|
0.20
|
|
|
76,364
|
|
|
June 19, 2013
|
|
June 19, 2023
|
June 23, 2014
|
|
1.48
|
|
|
400,000
|
|
|
June 23, 2015
|
|
June 23, 2024
|
July 15, 2014
|
|
1.26
|
|
|
847,500
|
|
|
July 15, 2016
|
|
July 15, 2024
|
July 15, 2014
|
|
0.80
|
|
|
100,000
|
|
|
May 30, 2015
|
|
May 30, 2023
|
January 21, 2015
|
|
1.23
|
|
|
75,000
|
|
|
January 21, 2017
|
|
January 21, 2025
|
June 16, 2015
|
|
1.43
|
|
|
2,252,333
|
|
|
June 16, 2017
|
|
June 16, 2025
|
October 15, 2015
|
|
1.31
|
|
|
50,000
|
|
|
October 15, 2017
|
|
October 15, 2025
|
June 23, 2016
|
|
0.01
|
|
|
110,576
|
|
|
July 21, 2016
|
|
June 23, 2026
|
June 23, 2016
|
|
1.05
|
|
|
250,000
|
|
|
June 23, 2019
|
|
June 23, 2026
|
June 23, 2016
|
|
1.05
|
|
|
363,092
|
|
|
June 23, 2017
|
|
June 23, 2026
|
April 11, 2017
|
|
1.85
|
|
|
150,436
|
|
|
April 11, 2018
|
|
April 11, 2027
|
April 11, 2017
|
|
1.85
|
|
|
324,324
|
|
|
April 11, 2020
|
|
April 11, 2027
|
April 11, 2017
|
|
1.85
|
|
|
762,764
|
|
|
June 23, 2019
|
|
April 11, 2027
|
June 27, 2017
|
|
1.80
|
|
|
34,711
|
|
|
June 27, 2017
|
|
June 27, 2027
|
July 18, 2017
|
|
1.83
|
|
|
533,629
|
|
|
June 18, 2018
|
|
June 18, 2027
|
July 18, 2017
|
|
1.83
|
|
|
367,924
|
|
|
July 18, 2020
|
|
July 18, 2027
|
October 24, 2017
|
|
1.80
|
|
|
481,975
|
|
|
October 24, 2018
|
|
October 24, 2027
|
October 24, 2017
|
|
1.80
|
|
|
297,271
|
|
|
October 24, 2020
|
|
October 24, 2027
|
|
|
|
|
7,491,880
|
|
|
|
|
|
|
|
|
|
|
8,577,236
|
|
|
|
|
|
|
Weighted
average
exercise price
£
|
|
Year ended January 31, 2018
|
|
Weighted
average
exercise price
£
|
|
Year ended January 31, 2017
|
||||
Outstanding at February 1,
|
1.17
|
|
|
7,383,401
|
|
|
1.29
|
|
|
7,006,306
|
|
Granted during the year
|
1.83
|
|
|
2,972,903
|
|
|
0.98
|
|
|
1,667,576
|
|
Lapsed during the year
|
0.99
|
|
|
(1,430,532
|
)
|
|
1.90
|
|
|
(916,700
|
)
|
Exercised during the year
|
1.13
|
|
|
(348,536
|
)
|
|
0.76
|
|
|
(373,781
|
)
|
Number of outstanding options at January 31,
|
1.43
|
|
|
8,577,236
|
|
|
1.17
|
|
|
7,383,401
|
|
Date of grant
|
|
Type of
award
|
|
Number of
shares
|
|
Exercise
price (£)
|
|
Share price
at grant
date (£)
|
|
Fair value
per option
(£)
|
|
Award
life
(years)
|
|
Risk free
rate
|
|||||
April 07, 2011
|
|
EMI
|
|
5,873
|
|
|
0.65
|
|
|
0.65
|
|
|
0.47
|
|
|
5.00
|
|
2.70
|
%
|
April 07, 2011
|
|
Unapproved
|
|
13,981
|
|
|
0.65
|
|
|
0.65
|
|
|
0.47
|
|
|
5.00
|
|
2.70
|
%
|
May 10, 2012
|
|
EMI
|
|
150,046
|
|
|
0.60
|
|
|
0.52
|
|
|
0.24
|
|
|
5.00
|
|
1.00
|
%
|
December 24, 2012
|
|
EMI
|
|
21,500
|
|
|
0.85
|
|
|
0.85
|
|
|
0.59
|
|
|
5.00
|
|
0.90
|
%
|
January 31, 2013
|
|
EMI
|
|
72,973
|
|
|
0.20
|
|
|
0.94
|
|
|
0.74
|
|
|
5.00
|
|
1.00
|
%
|
December 18, 2013
|
|
Unapproved
|
|
76,364
|
|
|
0.20
|
|
|
1.85
|
|
|
1.65
|
|
|
5.00
|
|
1.00
|
%
|
June 23, 2014
|
|
Unapproved
|
|
400,000
|
|
|
1.48
|
|
|
1.50
|
|
|
0.92
|
|
|
3.80
|
|
1.30
|
%
|
July 15, 2014
|
|
EMI
|
|
249,621
|
|
|
1.26
|
|
|
1.26
|
|
|
0.65
|
|
|
3.00
|
|
1.30
|
%
|
July 15, 2014
|
|
Unapproved
|
|
847,500
|
|
|
1.26
|
|
|
1.26
|
|
|
0.65
|
|
|
3.00
|
|
1.30
|
%
|
July 15, 2014
|
|
Unapproved
|
|
100,000
|
|
|
0.80
|
|
|
0.81
|
|
|
0.65
|
|
|
1.90
|
|
0.50
|
%
|
January 21, 2015
|
|
EMI
|
|
25,000
|
|
|
1.23
|
|
|
1.22
|
|
|
0.64
|
|
|
3.00
|
|
0.60
|
%
|
January 21, 2015
|
|
Unapproved
|
|
75,000
|
|
|
1.23
|
|
|
1.22
|
|
|
0.64
|
|
|
3.00
|
|
0.60
|
%
|
June 15, 2015
|
|
Unapproved
|
|
2,252,333
|
|
|
1.43
|
|
|
1.44
|
|
|
0.65
|
|
|
3.00
|
|
0.91
|
%
|
October 15, 2015
|
|
Unapproved
|
|
50,000
|
|
|
1.31
|
|
|
1.36
|
|
|
0.57
|
|
|
3.00
|
|
0.70
|
%
|
June 23, 2016
|
|
EMI
|
|
560,343
|
|
|
1.05
|
|
|
1.05
|
|
|
0.25
|
|
|
3.00
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
110,576
|
|
|
0.01
|
|
|
1.05
|
|
|
1.04
|
|
|
0.50
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
250,000
|
|
|
1.05
|
|
|
1.05
|
|
|
0.24
|
|
|
3.00
|
|
0.30
|
%
|
June 23, 2016
|
|
Unapproved
|
|
363,092
|
|
|
1.05
|
|
|
1.05
|
|
|
0.25
|
|
|
3.00
|
|
0.30
|
%
|
April 11, 2017
|
|
Unapproved
|
|
150,436
|
|
|
1.85
|
|
|
1.85
|
|
|
0.68
|
|
|
3.00
|
|
0.07
|
%
|
April 11, 2017
|
|
Unapproved
|
|
324,324
|
|
|
1.85
|
|
|
1.85
|
|
|
0.72
|
|
|
3.00
|
|
0.13
|
%
|
April 11, 2017
|
|
Unapproved
|
|
762,764
|
|
|
1.85
|
|
|
1.85
|
|
|
0.76
|
|
|
2.20
|
|
0.07
|
%
|
June 27, 2017
|
|
Unapproved
|
|
34,711
|
|
|
1.80
|
|
|
1.78
|
|
|
0.64
|
|
|
3.00
|
|
0.23
|
%
|
July 18, 2017
|
|
Unapproved
|
|
533,629
|
|
|
1.83
|
|
|
1.83
|
|
|
0.66
|
|
|
3.00
|
|
0.26
|
%
|
July 18, 2017
|
|
Unapproved
|
|
367,924
|
|
|
1.83
|
|
|
1.83
|
|
|
0.74
|
|
|
3.00
|
|
0.31
|
%
|
October 24, 2017
|
|
Unapproved
|
|
481,975
|
|
|
1.80
|
|
|
1.70
|
|
|
0.57
|
|
|
3.00
|
|
0.46
|
%
|
October 24, 2017
|
|
Unapproved
|
|
297,271
|
|
|
1.80
|
|
|
1.70
|
|
|
0.66
|
|
|
3.00
|
|
0.55
|
%
|
|
|
|
|
8,577,236
|
|
|
|
|
|
|
|
|
|
|
|
a.
|
Black-Scholes valuation methodology was used for all share options issued since 2016.
|
b.
|
The majority of share option awards made before 2016 are performance related and have been modeled using the Monte-Carlo methodology. The options granted on
January 31, 2013 and December 18, 2013 at an exercise price of
20
pence respectively, and
16,667
of the unapproved options granted on June 23, 2014 are not performance related.
|
c.
|
Figures in the range of
39%
-
134%
have been used for expected volatility. This has been derived from historic share price performance, weighted to exclude periods of unusually high volatility.
|
d.
|
Expected dividend yield is nil, consistent with the Directors’ view that the Group’s business model is to generate value through capital growth rather than the payment of dividends.
|
e.
|
The risk free rate is equal to the prevailing UK Gilts rate at grant date that most closely matches the expected term of the grant.
|
f.
|
Share options are assumed to be exercised immediately on vesting.
|
g.
|
The fair value of share options awarded where there are different vesting installments is the average of the fair values calculated per installment.
|
Date of grant
|
Exercise
price (£)
|
|
Number of
shares
|
|
Date from which
exercisable
|
|
Expiry date
|
||
July 18, 2017
|
0.01
|
|
|
136,991
|
|
|
July 18, 2018
|
|
December 31, 2018
|
October 24, 2017
|
0.01
|
|
|
138,886
|
|
|
October 24, 2018
|
|
December 31, 2018
|
|
|
|
275,877
|
|
|
|
|
|
|
Weighted
average exercise price £ |
|
Year ended January 31, 2018
|
|
Weighted
average exercise price £ |
|
Year ended January 31, 2017
|
||||
Outstanding at February 1,
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Granted during the year
|
0.01
|
|
|
275,877
|
|
|
—
|
|
|
—
|
|
Number of outstanding RSUs at January 31,
|
0.01
|
|
|
275,877
|
|
|
—
|
|
|
—
|
|
Date of grant
|
|
Number of
shares
|
|
Exercise
price (£)
|
|
Share price
at grant
date (£)
|
|
Fair value
per option
(£)
|
|
Award
life
(years)
|
|
Risk free
rate
|
|||||
July 18, 2017
|
|
136,991
|
|
|
0.01
|
|
|
1.83
|
|
|
1.82
|
|
|
1.00
|
|
0.24
|
%
|
October 24, 2017
|
|
138,886
|
|
|
0.01
|
|
|
1.70
|
|
|
1.69
|
|
|
1.00
|
|
0.40
|
%
|
|
|
275,877
|
|
|
|
|
|
|
|
|
|
|
|
a.
|
Black-Scholes valuation methodology was used for all RSUs.
|
b.
|
Figures in the range of
47%
-
84%
have been used for expected volatility. This has been derived from historic share price performance, weighted to exclude periods of unusually high volatility.
|
c.
|
Expected dividend yield is nil, consistent with the Directors’ view that the Group’s business model is to generate value through capital growth rather than the payment of dividends.
|
d.
|
The risk free rate is equal to the prevailing UK Gilts rate at grant date that most closely matches the expected term of the grant.
|
e.
|
RSUs are assumed to be exercised immediately on vesting.
|
|
Land & Buildings
|
||||
|
January 31, 2018
|
|
January 31, 2017
|
||
|
£000
|
|
£000
|
||
Leases which expire
|
|
|
|
||
Not later than one year
|
337
|
|
|
88
|
|
Later than one year and not later than five years
|
1,143
|
|
|
122
|
|
|
1,480
|
|
|
210
|
|
|
|
£000
|
|
Consideration
|
|
|
|
Cash
|
|
6,091
|
|
2,934,272 new Summit Therapeutics plc Ordinary Shares issued
|
|
5,000
|
|
Total consideration
|
|
11,091
|
|
|
Book value £000
|
|
Fair value adjustment £000
|
|
Fair value £000
|
|||
Recognized amounts of identifiable assets acquired and liabilities assumed
|
|
|
|
|
|
|||
Cash and cash equivalents
|
1,316
|
|
|
—
|
|
|
1,316
|
|
Property, plant and equipment
|
329
|
|
|
—
|
|
|
329
|
|
Intangible assets - option over non-financial assets
|
668
|
|
|
—
|
|
|
668
|
|
Intangible assets - bacterial genetics-based platform
|
—
|
|
|
10,670
|
|
|
10,670
|
|
Trade and other receivables
|
1,129
|
|
|
—
|
|
|
1,129
|
|
Trade and other payables
|
(1,555
|
)
|
|
—
|
|
|
(1,555
|
)
|
Assumed contingent liabilities
|
—
|
|
|
(1,466
|
)
|
|
(1,466
|
)
|
Deferred tax liabilities
|
—
|
|
|
(1,814
|
)
|
|
(1,814
|
)
|
Book and fair value of identifiable net assets
|
1,887
|
|
|
7,390
|
|
|
9,277
|
|
Goodwill
|
—
|
|
|
1,814
|
|
|
1,814
|
|
Total consideration
|
1,887
|
|
|
9,204
|
|
|
11,091
|
|
1.
|
CLIN 0001 (the base period segment), and CLINs 0002 through CLIN 0004 (option period segments) are cost-sharing CLINs. Monies shall be provided for the total cost of performance from the Department of Health and Human Services, and the Contractor, Summit.
|
2.
|
The Government shall provide monies for the base period segment (CLIN 0001) in an amount not to exceed $31,967,000. The Government will not be responsible for any Contractor incurred costs that exceed this amount unless a modification to the contract is signed by the Contracting Officer which expressly increases this amount. The Contractor's share is estimated at $[**].
|
3.
|
The Contractor shall maintain records of all contract costs (including costs claimed by the Contractor as being its share) and such records shall be subject to the Audit and Records-Negotiation and Final Decisions on Audit Findings clauses of the General Clauses.
|
4.
|
Costs contributed by the Contractor shall not be charged to the Government under any other contract, grant, or cooperative agreement (including allocation to other grants, contracts, or cooperative agreements as part of an independent research and development program). The Contractor shall report the organization's share of the costs expended by category, on the Financial Report, as referenced in the CONTRACT FINANCIAL REPORT Article in SECTION G of this contract.
|
5.
|
It is estimated that the amount currently allotted will cover performance of the contract through September 30, 2018.
|
a.
|
Unless the Government exercises its option pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract), contained in ARTICLE I.2, the contract consists only of the base period (CLIN 0001) specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2 of the contract.
|
b.
|
Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract), the Government may, by unilateral contract modification, require the Contractor to perform the remaining Option Work Segments specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government decides to exercise an option(s), the Government will provide the Contractor a preliminary written notice of its intent to exercise the option at least [**] days before the contract expires. If Option 1 CLIN 0002, Option 2 CLIN 0003 and Option 3 CLIN 0004 are exercised, the estimated cost of the contract will be increased as set forth in the table below:
|
Option CLIN
|
Period of Performance
|
Supplies/Services
|
Government Share
|
Contractor Share
|
Total
Cost
|
Option1/0002
|
[**], 2018
through
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
Option 2/ 0003
|
[**], 2018
through
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
Option 3/ 0004
|
[**], 2020 through
[**], 2022
|
[**]
|
[**]
|
[**]
|
[**]
|
|
TOTAL
|
|
$61,994,045
|
[**]
|
[**]
|
1.
|
Acquisition, by purchase or lease, of any interest in real property;
|
2.
|
Special rearrangement or alteration of facilities;
|
3.
|
Accountable Government Property (
see
the HHS Contracting Guide for Control for Government Property incorporated by ARTICLE G.10. of this contract);
|
a.
|
Note: this includes the lease or purchase of
any
item of general purpose office furniture or office equipment regardless of dollar value.
|
4.
|
Purchase or lease scientific instruments or equipment over $1,500;
|
5.
|
Travel to attend general scientific meetings/conferences;
|
6.
|
Unapproved travel in excess of the dollar amounts specified under subparagraph b.1 below
|
7.
|
Printing Costs (as defined in the Government Printing and Binding Regulations);
|
8.
|
Overtime (premium) compensation
|
9.
|
Entering into certain types subcontract of arrangements (See Article B.5(c) for specific obligations). Note that most consulting agreements require CO’s written consent.
|
10.
|
Foreign Travel (see Subparagraph b.3);
|
11.
|
Patient care costs (see Attachment 6);
|
12.
|
Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meetings, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provide; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.
|
1.
|
Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the base period segment (CLIN 0001) shall not exceed $[**] without the prior written approval of the Contracting Officer. The Contractor shall notify the Contracting Officer in writing when travel expenditures have exceeded [**]% ($[**]) of the base period segment (CLIN 0001) travel expenses. Cost must be consistent with Federal Acquisition Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers whenever relevant..
|
2.
|
Subject to the annual dollar limitation specified under B.4.b.1. above, the Contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs.
|
3.
|
If international travel is necessary, a Contracting Officer Authorization (COA) will be required. Expenditures for international travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the Contracting Officer.
|
a.
|
meeting(s) and place(s) to be visited, with costs and dates;
|
b.
|
name(s) and title(s) of Contractor personnel to travel and their functions in the contract project;
|
c.
|
contract purposes to be served by the travel;
|
d.
|
how travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of ASPR contract funds;
|
e.
|
how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and
|
f.
|
what additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.
|
a.
|
Security
|
b.
|
Subcontracts
|
•
|
Is of the cost-reimbursement type; or
|
•
|
Is Fixed-Price and exceeds $[**] or [**]% of the total estimated cost of the Contract, whichever value is greater.
|
c.
|
Sharing of contract deliverables within United States Government (USG)
|
d.
|
Overtime Compensation
|
a.
|
Site Visits and Inspections
|
•
|
If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within [**] business days detailing the finding and corrective action(s) of the audit.
|
•
|
COR and CO will review the report and provide a response to the Contractor within [**] business days.
|
•
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
a.
|
Summary of Contract Deliverables
|
CDRL#
|
Deliverable
|
Deliverable Description
|
Reporting Procedures and Due Dates
|
1
|
Kickoff Meeting
|
The Contractor shall complete a Kickoff meeting after contract award
|
•
Due: Within [**] of contract award.
•
Materials: Contractor shall provide itinerary and agenda to CO and COR at least [**] business days in advance of site visit. CO approves and and the COR distributes itinerary and agenda within [**] business days.
•
Due out: Contractor provides meeting minutes to CO and COR within [**] business days after the meeting. The CO and COR reviews, comments, and the CO approves minutes within [**] business days.
|
2
|
Quarterly Meetings
|
The Contractor shall hold recurring teleconference or face-to-face Project Review Meetings approximately every third month either in Washington D.C or at work sites of the Contractor or subcontractors. Face-to-face meetings shall alternate between Washington DC and Contractor, sub-contractor sites, with the first to be held in Washington DC. The meetings will be used to discuss contract progress in relation to the Program Management deliverables described below as well as study designs, technical, regulatory, and ethical aspects of the program.
|
•
Materials: Contractor shall provide itinerary and agenda to CO and COR at least [**] business days in advance of site visit. The COR approves and distributes itinerary and agenda within [**] business days.
•
Due out: Contractor provides meeting minutes to the CO and the COR within [**] business days after the meeting. The CO and COR reviews, comments, and the CO approves minutes within [**] business days.
|
3
|
[**]Teleconference Meetings
|
The Contractor shall participate in teleconferences every [**] [**] with the CO and the COR to discuss the performance of the contract.
|
•
Materials: Contractor provides agenda to the CO and COR no later than [**] business days in advance of meeting. The COR approves anddistributes agenda prior to meeting.
•
Due out: Contractor provides meeting minutes to the CO and COR within [**] business days following the meeting. The CO and COR reviews, comments, and the COR approves minutes within [**] business days following the meeting.
|
CDRL#
|
Deliverable
|
Deliverable Description
|
Reporting Procedures and Due Dates
|
04 (Monthly)
05 (Annual)
|
Monthly & Annual Technical Progress Reports
|
The Monthly and Annual Technical Progress report shall address each of the below items and be cross-referenced to the Work Breakdown Structure (WBS), Statement of Work (SOW), Integrated Master Schedule (IMS), Performance Measurement Baseline Review report (PMBR), Earned Value Management (EVM), and Contract Performance Report (CPR).
1.
An Executive Summary highlighting the progress, issues and relevant manufacturing, non-clinical, clinical and regulatory activities. The Executive Summary should highlight only critical issues for that reporting period and resolution approach; limited to 2-3 pages.
2.
Progress in meeting contract milestones – broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned and actual progress during the period covered, explaining occurrences of any differences between the two and the corrective steps.
3.
The reports shall also include a [**]-month rolling forecast of the key planned activities, referencing the WBS/IMS.
4.
A tracking log of progress on regulatory submissions with the FDA number, description of submission, date of submission, status of submission and next steps.
5.
Provide updated EVM/CPR.
6.
Estimated and Actual Expenses.
7.
This report shall also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses should be broken down to the appropriate WBS level. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month. If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.
|
•
Due: Monthly Reports shall be submitted on the [**] day of the month after the end of each month with an Annual Report submitted on the [**] calendar day of the final month of each contract year for the previous twelve calendar months. Monthly progress reports are not required for the periods when the Annual Report(s) and Final Report are due. The CO and the COR will review the monthly reports and provide feedback within [**] business days of receiving the report . The CO approves acceptance of monthly and annual reports.
|
A.
|
Monthly and Annual Progress Reports
|
i.
|
Monthly Progress Report
|
•
|
A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission;
|
•
|
SECTION I – EXECUTIVE SUMMARY
|
•
|
SECTION II - PROGRESS
|
•
|
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.
|
•
|
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all material meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g., evaluating, and managing subcontractor performance, and personnel changes).
|
•
|
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to Gantt chart, document the results of work completed and cost incurred during the period covered in relation to proposed progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project.
|
•
|
SECTION II Part D: PROPOSED WORK - A summary of work proposed related to Gantt chart for the next reporting period and preprints/reprints of papers and abstracts.
|
•
|
SECTION III: Estimated and Actual Expenses.
|
•
|
SECTION IV: Earned Value Management Reporting: Contractor will provide a monthly Contract Performance Report (CPR) at an agreed upon reporting level (WBS level 3) using the Government provided WBS and a Variance Analysis Report. EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR 52.215-2, Audit and Records-Negotiation, the Contracting Officer may request, on a quarterly or ad hoc basis, that the Contractor provide raw data. The CO may request additional data at a reporting level or at lower levels, as the CO deems necessary.
|
ii.
|
Annual Progress Report
|
•
|
A Cover page that includes the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and email address; and the date of submission;
|
•
|
SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the major accomplishments achieved during the reporting period.
|
•
|
SECTION II: PROGRESS
|
•
|
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.
|
•
|
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A high level summary of critical meetings, etc. that have taken place during the reporting period. Include progress on administration and management to critical factors of the project (e.g. regulatory compliance audits and key personnel changes).
|
•
|
SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work performed structured to follow the activities and decision gates outlined at the Integrated Baseline Review and as described in the Integrated Master Plan. The Report should include a description of any problems (technical or financial) that occurred or were identified during the reporting period, and how these problems were resolved.
|
•
|
SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year period to include an updated Gantt Chart.
|
•
|
SECTION III: Estimated and Actual Expenses.
|
•
|
SECTION IV: EARNED VALUE MANAGEMENT REPORTING - Contractor will provide a quarterly Contract Performance Report (CPR) at an agreed upon (WBS level 3) reporting level using the Government provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR 52.215-2, Audit and Records-Negotiation, the Government may request, on a quarterly or ad hoc basis, that the Contractor provide raw data. The Government may request additional data at a reporting level or at lower levels, as the Government deems necessary.
|
1.
|
Copies of manuscripts (published and unpublished), abstracts, and any protocols or methods developed specifically under the contract during the reporting period; and
|
2.
|
A summary of any Subject Inventions per the requirements under FAR Clause 52.227-11.
|
iii.
|
Draft Final Report and Final Report
|
1.
|
Cover page to include the contract number, contract title, performance period covered, Contractor's name and address, telephone number, fax number, email address and submission date.
|
2.
|
SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.
|
3.
|
SECTION II: RESULTS - A detailed description of the work performed related to WBS and Gantt chart, the results obtained, and the impact of the results on the scientific and/or public health community including a listing of all manuscripts (published and in preparation) and abstracts presented during the entire period of performance and a summary of all inventions.
|
iv.
|
Summary of Salient Results
|
v.
|
Audit Reports
|
vi.
|
Other Technical Reports
|
1.
|
Draft Report for Clinical and Non-Clinical Studies and Final Report for Clinical and Non-Clinical Studies
|
•
|
The clinical trial reports shall follow the format of International Conference on Harmonization document ICH E3 “Guideline for Industry on Structure and Content of Clinical Study Reports”
|
•
|
Draft Final Report for Clinical and Non-Clinical Studies funded by this contract will be submitted to the COR and CO for review and comment within the time frames set forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2.
|
•
|
Subcontractor prepared reports received by the Contractor shall be submitted to the CO and COR for review and comment as set forth by the table in this Article. Contractor shall consider revising reports to address the CO’s and COR’s recommendations prior to FDA submission.
|
•
|
The Government shall provide written comments to the Draft Final Report for Clinical and Non-Clinical Studies in accordance with the dates set forth by the table in this Article.
|
•
|
The comprehensive Final Report for Clinical and Non-Clinical Studies will be submitted to the CO and the COR set forth by the table in this Article.
|
2.
|
Supplemental Technical Documents
|
B.
|
Deliverables Arising from FDA Correspondence
|
i.
|
FDA Meetings
|
•
|
Contractor shall notify the Contracting Officer of upcoming FDA meeting within [**] of scheduling Type A, B or C meetings OR within [**] of meeting occurrence for ad hoc meetings.
|
•
|
The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to the CO and COR within [**] business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”
|
ii.
|
FDA Submissions
|
•
|
If draft documents are submitted for CO/COR review, the Government will provide feedback to Contractor within [**] business days of receipt.
|
•
|
If the CO and the COR review draft documents, the Contractor shall revise their documents to address the Government’s written concerns and/or recommendations prior to FDA submission.
|
•
|
Final FDA submissions shall be submitted to the CO and the COR concurrently or no later than [**] of their submission to FDA.
|
iii.
|
FDA Audits
|
•
|
Contractor shall notify CO and COR within [**] business days of a scheduled FDA audit or within [**] after an ad hoc site visit/audit if the FDA does not provide advanced notice.
|
•
|
Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within [**] business days after receiving correspondence from the FDA, Subcontractor, or third party.
|
•
|
Within [**] business days after receiving any FDA audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified.
|
iv.
|
Manufacturing Campaign Reports
|
•
|
Contractor will submit Manufacturing Campaign Reports to the CO and the COR at least [**] business days prior to FDA submission.
|
•
|
If corrective action is recommended, Contractor must address, in writing, all concerns raised by the CO or the COR in writing.
|
•
|
Contractor shall revise the reports to reasonably address the CO’s or COR’s concerns and/or recommendations prior to FDA submission.
|
•
|
Final FDA submission shall be submitted to the CO and COR concurrently or no later than [**] after submission to the FDA.
|
v.
|
Other FDA Correspondence
|
C.
|
Earned Value Management (EVM) Deliverables
|
i.
|
Earned Value Management (EVM) / Contract Performance Report (CPR)
|
•
|
Contractor shall provide EVM/CPR as part of the Monthly Progress Report (this requirement begins only as set forth in the Contract Milestones & Related Deliverables table, see CDRL #4)
|
•
|
Contractor shall provide top level or key changes in baseline cost as a result of anticipated cost savings or risks
|
•
|
The Government may request, on a monthly or ad hoc basis that the Contractor provide raw data at a reporting level or lower level as the Government deems necessary.
|
•
|
Contractor must address, in writing, all concerns raised by the Government in writing.
|
•
|
Reporting will commence after the EVM system has been implemented but no later than [**] days after start of base period and each exercised option period.
|
ii.
|
Integrated Master Plan (IMP)
|
•
|
Contractor shall provide the draft IMP within [**] days of contract award with final due [**] months after award and updated monthly as part of the Monthly Progress Report
|
•
|
Contractor must address, in writing, all concerns raised by the Government in writing
|
iii.
|
Performance Measurement Baseline Review (PMBR)
|
1.
|
Contractor provides baseline proposal
|
2.
|
Responsibility Assignment Matrix
|
3.
|
A description of the work scope through control account Work Authorization Documents and/or WBS Dictionary down to the agreed upon control account level.
|
4.
|
Template for work packages
|
5.
|
Integrated Master Schedule (IMS) with the inclusion of agreed major milestones and control account plans for all control accounts
|
6.
|
Baseline revision documentation and program log(s) risk management plan
|
•
|
PMBR is due within [**] days of contract award
|
•
|
Contractor shall provide baseline proposal .ppt briefing [**] business days prior to meeting
|
•
|
Contractor provides agenda to COR [**] business days in advance of meeting
|
•
|
CO approves and distributes agenda
|
•
|
CO approves all meeting material
|
•
|
Contactor provides minutes with [**] business days of the meeting
|
•
|
CO and COR reviews and approves minutes
|
•
|
CO and COR will review documentation and provide written comments and questions to Contractor
|
•
|
Contractor shall address the Government’s comments and resubmit PMBR report for CO/COR approval within [**] business days.
|
iv.
|
Risk Management Plan
|
•
|
Due within [**] days of contract award
|
•
|
Contractor provides updated Risk Management Plan in Monthly Progress Report
|
•
|
The CO shall provide Contractor with a written list of concerns in response to the plan submitted. The Contractor must address, in writing, all concerns raised by the Government in writing within [**] business days of Contractor’s receipt of the Government’s concerns.
|
v.
|
Requirement for Notification of Deviation and Mitigation Strategy
|
GO-NOGO Milestone #
|
Milestone definition
|
Success criteria
|
Failure criteria
|
Deliverable to achieve milestone
|
WBS Element
|
CLIN Initiated by Milestone Success
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
1.4.3
|
2
|
2
|
[**]
|
[**]
|
[**]
|
[**]
|
1.6.3.2
and
1.4.4.3
|
2
|
3
|
[**]
|
[**]
|
[**]
|
[**]
|
1.6.3.1
|
3
|
4
|
[**]
|
[**]
|
[**]
|
[**]
|
1.4.3
|
4
|
5
|
[**]
|
[**]
|
[**]
|
[**]
|
1.4.3
|
4
|
6
|
[**]
|
[**]
|
[**]
|
[**]
|
1.6.3
and
1.6.4
|
4
|
7
|
[**]
|
[**]
|
[**]
|
[**]
|
1.5.2.2
|
NA
|
1)
|
The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.
|
2)
|
The Contracting Officer is the only person with the authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimburse to the Contractor of any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract.
|
3)
|
No information other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the US Government, other otherwise, shall be considered grounds for deviation from any stipulation of this contract.
|
4)
|
The Government may unilaterally change its CO designation. It will notify Contractor in writing of such change.
|
1)
|
Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;
|
2)
|
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;
|
3)
|
Performing technical evaluation as required;
|
4)
|
Performing technical inspections and acceptances required by this contract; and
|
5)
|
Assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its COR designation, after which it will notify Contractor in writing of such change..
|
#
|
NAME
|
ORGANIZATION
|
TITLE
|
1
|
[**]
|
[**]
|
[**]
|
2
|
[**]
|
[**]
|
[**]
|
3
|
[**]
|
[**]
|
[**]
|
a.
|
Financial reports on the attached Financial Report of Individual Project/Contract shall be submitted by the Contractor to the CO with a copy to the COR in accordance with the instructions for completing this form, which accompany the form, in an original and one electronic copy, not later than the [**] business day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories), which shall be reported within the total contract, are discussed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.
|
b.
|
Unless otherwise stated in the instructions for completing this form, all columns A through J, shall be completed for each report submitted.
|
c.
|
The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.
|
d.
|
The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.
|
e.
|
The listing of expenditure categories to be reported is incorporated as a part of this contract and can be found under SECTION J Attachment 3 entitled, "Financial Report of Individual Project/Contract".
|
f.
|
The USG may unilaterally revise the “Financial Report of Individual Project/Contract” to reflect the allotment of additional funds.
|
PSC_Invoices@psc.hhs.gov
|
[**]
Contracting Officer DHHS/OS/ASPR/AMCG Room [**] –O’Neill House Office Building Washington, DC 20515
Email [**]
|
[**]
Contracting Specialist DHHS/OS/ASPR/AMCG Room [**] – O’Neill House Office Building Washington, DC 20515
Email: [**]
|
[**]
Contracting Officer Representative
DHHS/ASPR/BARDA
Room [**] -O’Neill House Office Building
Washington, DC 20515
Email: [**]
|
a.
|
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting.
|
b.
|
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the USG.
|
c.
|
The Contractor agrees to immediately notify the CO in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any option period(s) (See estimated costs under Articles B.2) and the reasons for the variance. These requirements are in addition to the specified requirements of FAR Clause 52.232-20, Limitation of Cost that is incorporated by reference under Article I.1 which states:
|
d.
|
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
|
e.
|
An electronic copy of the payment request shall be uploaded into the designated eRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an e-mail notification of the upload will be provided to the CO and COR.
|
f.
|
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment (Jan 2017).
|
g.
|
Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget.
|
a.
|
Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), and amount claimed.
|
b.
|
Fringe Benefits - Cite rate and amount
|
c.
|
Overhead - Cite rate and amount
|
d.
|
Materials & Supplies - Include detailed breakdown when total amount is over
|
e.
|
Travel - Identify travelers, dates, destination, purpose of trip, and total breaking out amounts for transportation (plane, car etc), lodging, M&IE. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.
|
f.
|
Consultant Fees - Identify individuals, amounts and activities. Cite appropriate COA
|
g.
|
Subcontracts - Attach subcontractor invoice(s). Cite appropriate COA
|
h.
|
Equipment - Cite authorization and amount. Cite appropriate COA
|
i.
|
Other Direct Costs - Include detailed breakdown when total amount is over
|
j.
|
G&A - Cite rate and amount.
|
k.
|
Total Cost
|
1)
|
The Government shall reimburse the Contractor the cost determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR Clause 52.216-7, Allowable Cost and Payment incorporated by reference in Section I, Contract Clauses, of this contract, and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:
|
a)
|
All direct materials and supplies that are used in performing the work provided for under the contract, including those purchased for subcontracts and purchase orders.
|
b)
|
All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.
|
c)
|
All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.
|
d)
|
Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following:
|
(i)
|
Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).
|
(ii)
|
Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.
|
(iii)
|
Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).
|
(iv)
|
Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.
|
1.
|
Non-Clinical Terms of Award
|
a.
|
Safety and Monitoring Issues
|
i.
|
PHS Policy on Humane Care and use of Laboratory Animals
|
•
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
•
|
All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable).
|
•
|
Termination or temporary suspension of the study(ies) for regulatory issues.
|
•
|
Termination or temporary suspension of the protocol.
|
•
|
Any change that is made in the specific IACUC approval for the indicated study(ies).
|
•
|
Any other problems or issues that could affect the scientific integrity of the study(ies), i.e., fraud, misrepresentation, misappropriation of funds, etc.
|
ii.
|
Non-Clinical Data and Safety Monitoring Requirements
|
b.
|
BARDA Review Process before Non-Clinical study Execution Begins
|
•
|
IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria.
|
•
|
For non-pivotal mouse studies, the Contractor will provide an annual animal care and use protocol.
|
•
|
Documentation of IACUC approval, including OLAW federal wide number, IACUC registration number, and IACUC name.
|
•
|
Contractor should reduce the number of animals required for a study using power of statistics.
|
•
|
Plans for the management of side effects, rules for interventions and euthanasia criteria.
|
•
|
Procedures for assessing and collecting safety data were appropriate.
|
•
|
If a study is contracted through Contract Research Organizations (CROs), work orders and service agreements the Contractor shall assure an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology).
|
•
|
Documentation that the Contractor and all required staff responsible for the conduct of the research have received training in the protection and handling of animals, or that the CRO has the required documentation.
|
•
|
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer in accordance with the contract. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third part, in the event that the Contracting Officer Authorization is not granted.
|
•
|
Provide justification for whether studies require good laboratory practice (GLP) conditions.
|
•
|
Provide justification for whether studies will be classified as non-pivotal or pivotal studies.
|
c.
|
References
|
a.
|
Safety and Monitoring Issues
|
i.
|
Institutional Review Board or Independent Ethics Committee Approval
|
•
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid.
|
•
|
All changes in informed consent documents, identified by version number, dates, or both and dates it is valid.
|
•
|
Termination or temporary suspension of patient accrual.
|
•
|
Termination or temporary suspension of the protocol.
|
•
|
Any change in IRB approval.
|
•
|
Any other problems or issues that could affect the participants in the studies.
|
ii.
|
Data and Safety Monitoring Requirements
|
▪
|
Independent Safety Monitor
– a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.
|
▪
|
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC)
– a small group of independent investigators and biostatisticians who review data from a particular study.
|
▪
|
Data and Safety Monitoring Board
– an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy
|
iii.
|
BARDA Protocol Review Process Before Patient Enrollment Begins
|
•
|
IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria.
|
•
|
Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name.
|
•
|
IRB- or IEC- approved informed consent document, identified by version number, date, or both and dates it is valid.
|
•
|
Plans for the management of side effects.
|
•
|
Procedures for assessing and reporting adverse events.
|
•
|
Plans for data and safety monitoring (see above) and monitoring of the clinical study site, pharmacy, and laboratory.
|
•
|
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects.
|
iv.
|
Investigational New drug or Investigational Device Exemption Requirements
|
v.
|
Required Time-Sensitive Notification
|
i.
|
Expedited safety report of unexpected or life-threatening experience or death:
|
ii.
|
Expedited safety reports of serious and unexpected adverse experiences:
|
iii.
|
IDE reports of unanticipated adverse device effect:
|
iv.
|
Expedited safety reports:
|
v.
|
Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to the CO and the COR annually.
|
vi.
|
Safety reporting for research not performed under an IND or IDE.
|
a.
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.
|
b.
|
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
|
c.
|
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
|
d.
|
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.
|
A.
|
Press Releases
|
•
|
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications.
|
•
|
Contractor shall notify the COR and CO within [**] business days of report completion.
|
•
|
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within [**] business days of the audit.
|
•
|
COR and CO will review the report and provide a response to the Contractor with [**] business days.
|
•
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
•
|
Within [**] of activity or incident or within [**] for a security related activity or incident, Contractor must notify BARDA through the CO and COR.
|
•
|
Additional updates due to COR and CO within [**] of additional developments.
|
•
|
Contractor shall submit within [**] business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.
|
a.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
|
FAR
CLAUSE #
|
DATE
|
TITLE
|
52.202-1
|
Nov 2013
|
Definitions
|
52.203-3
|
Apr 1984
|
Gratuities
|
52.203-5
|
May 2014
|
Covenant Against Contingent Fees
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the Government
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
52.203-8
|
May 2014
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
|
52.203-10
|
May 2014
|
Price or Fee Adjustment for Illegal or Improper Activity
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)
|
52.203-13
|
Oct 2015
|
Contractor Code of Business Ethics and Conduct
|
52.203-14
|
Oct 2015
|
Display of Hotline Poster(s)
|
52,203-17
|
Apr 2014
|
Contractor Employee Whistlelower Rights and Requirement to Inform Employees of Whistleblower rights
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Recycled Paper
|
52.204-7
|
Oct 2016
|
System for Award Management
|
52.204-10
|
Oct 2016
|
Reporting Executive Compensation and First-Tier Subcontract Awards
|
52.204-13
|
Oct 2016
|
System for Award Management Maintenance
|
52.209-6
|
Oct 2015
|
Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
|
52.209-9
|
Jul 2013
|
Updates of Publicly Available Information Regarding Responsibility Matters
|
52.209-10
|
Nov 2015
|
Prohibition on Contracting With Inverted Domestic Corporations
|
52.210-1
|
Apr 2011
|
Market Research
|
52.215-2
|
Oct 2010
|
Audit and Records – Negotiation
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Cost or Pricing Data (Over $700,000)
|
52.215-12
|
Oct 2010
|
Subcontractor Cost or Pricing Data (Over $700,000)
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions
|
FAR
CLAUSE #
|
DATE
|
TITLE
|
52.215-17
|
Oct 1997
|
Waiver of Facilities Capital Cost of Money
|
52.215-18
|
Jul 2005
|
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
|
52.215-19
|
Oct 1997
|
Notification of Ownership Changes
|
52.215-21
|
Oct 2010
|
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
52.216-7
|
Jun 2013
|
Allowable Cost and Payment
|
52.216-12
|
Apr 1984
|
Cost Sharing Contract – no fee
|
52.219-8
|
Nov 2016
|
Utilization of Small Business Concerns
|
52.222-2
|
Jul 1990
|
Payment for Overtime Premiums
|
52.222-3
|
Jun 2003
|
Convict Labor
|
52.222-21
|
Apr 2015
|
Prohibition of Segregated Facilities
|
52.222-26
|
Sep 2016
|
Equal Opportunity
|
52.222-35
|
Oct 2015
|
Equal Opportunity Veterans
|
52.222-36
|
Jul 2014
|
Affirmative Action for Workers with Disabilities
|
52.222-37
|
Feb 2016
|
Employment Reports on Veterans
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act
|
52.222-50
|
Mar 2015
|
Combating Trafficking in Persons Alternate I
|
52.222-54
|
Oct 2015
|
Employment Eligibility Verification
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policy to Ban Text Messaging While Driving
|
52.224-1
|
April 1984
|
Privacy Act Notification
|
52.224-2
|
April 1984
|
Privacy Act
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
52.227-1
|
Dec 2007
|
Authorization and Consent, Alternate I (Apr 1984)
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
52.227-3
|
Apr 1984
|
Patent Indemnity
|
52.227-11
|
May 2014
|
Patent Rights - Ownership by the Contractor The frequency of reporting in (i) is annual.
|
52.227-14
|
May 2014
|
Rights in Data-General
|
FAR
CLAUSE #
|
DATE
|
TITLE
|
52.227-14 –Alternate II
|
Dec 2007
|
Rights in Data – General, Alternate II.
Completed portion as follows:
Limited Rights Notice (Dec 2007)
(a) These data are submitted with limited rights under Government Contract No. HHSO100201700014C. These data may be reproduced and used by the Government with the express limitation that they will not, without written permission of the Contractor, be used for purposes of manufacture nor disclosed outside the Government; except that the Government may disclose these data outside the Government for the following purposes, provided that the Government makes such disclosure subject to prohibition against further use and disclosure:
(i) Use (except for manufacture) by support service
contractors.
(ii) Evaluation by nongovernment evaluators.
(b) This Notice shall be marked on any reproduction of these data, in whole or in part.
|
52.227-16
|
Jun 1987
|
Additional Data Requirements
|
52.229-8
|
Mar 1990
|
Taxes – Foreign Cost Reimbursement Contracts. Insert “Great Britain” in both blanks.
|
52.230-4
|
Oct 2015
|
Disclosure and Consistency of Cost Accounting Practices – Foreign Concerns
|
52.230-6
|
June 2010
|
Administration of Cost Accounting Standards
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
52.232-17
|
May 2014
|
Interest
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
52.232-23
|
May 2014
|
Assignment of Claims
|
52.232-25
|
Jan 2017
|
Prompt Payment, Alternate I (Feb 2002)
|
52.232-33
|
July 2013
|
Payment by Electronic Funds Transfer—System for Award Management
|
52.233-1
|
May 2014
|
Disputes
|
52.233-3
|
Aug 1996
|
Protest After Award, Alternate I (Jun 1985)
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
52.242-1
|
Apr 1984
|
Notice of Intent to Disallow Costs
|
52.242-3
|
May 2014
|
Penalties for Unallowable Costs
|
52.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
52.243-2
|
Aug 1987
|
Changes - Cost Reimbursement, Alternate V (Apr 1984)
|
52.244-2
|
Oct 2010
|
Subcontracts, Alternate I (June 2007)
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting
|
52.244-6
|
Jan 2017
|
Subcontracts for Commercial Items
|
52.245-1
|
Jan 2017
|
Government Property, Alternate II (Jun 2007)
|
52.245-9
|
Apr 2012
|
Use and Charges
|
52.246-23
|
Feb 1997
|
Limitation of Liability
|
52.247-63
|
Jun 2003
|
Preference for U.S.-Flag Air Carriers
|
52.249-6
|
May 2004
|
Termination (Cost-Reimbursement)
|
FAR
CLAUSE #
|
DATE
|
TITLE
|
52.249-14
|
Apr 1984
|
Excusable Delays
|
52.251-1
|
Apr 2012
|
Government Supply Sources
|
52.253-1
|
Jan 1991
|
Computer Generated Forms
|
b.
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
|
HHSAR
CLAUSE NO. |
DATE
|
TITLE
|
|
352.211-3
|
Dec 2015
|
Paperwork Reduction Act
|
|
352.203-70
|
Dec 2015
|
Anti-Lobbying
|
|
352.222-70
|
Dec 2015
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
|
352.223-70
|
Dec 2015
|
Safety and Health
|
|
352.224-70
|
Dec 2015
|
Privacy Act
|
|
352.227-70
|
Dec 2015
|
Publications and Publicity
|
|
352.231-70
|
Dec 2015
|
Salary Rate Limitation
|
|
352.233-71
|
Dec 2015
|
Litigation and Claims
|
|
352.237-75
|
Dec 2015
|
Key Personnel
|
|
352.270-4a
|
Dec 2015
|
Protection of Human Subjects
|
|
352.270-6
|
Dec 2015
|
Restriction on use of Human Subjects
|
b.
|
FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000)
|
c.
|
FAR Clause 52.219-28, Post-Award Small Business Program Representation (April 2009).
|
1.
|
Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.
|
2.
|
Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.
|
3.
|
For long-term contracts--
|
1)
|
Human Subjects Assurance Identification Numbers: To be provided prior to study execution
|
2)
|
Animal Welfare Assurance Numbers (OLAW/PHS): To be provided prior to study execution
|
1.
|
CLIN 1: [**]
|
2.
|
CLIN 2: [**]
|
3.
|
CLIN 3: [**]
|
4.
|
CLIN 4: [**]
|
5.
|
OTHER ITEMS
|
(a) Designated Billing Office Name and Address:
DHHS/OS/ASPR/BARDA
Attn: Contracting Officer 330 Independence Ave., S.W. Room G644 Washington, D.C. 20201
(b) Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
ABC CORPORATION
100 Main Street Anywhere, USA Zip Code
Name, Title, Phone Number, and E-mail Address of person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent.
VIN:
DUNS or DUNS+4: |
(c) Invoice/Financing Request No.:
(d) Date Invoice Prepared:
(e) Contract No. and Order No. (if applicable):
(f) Effective Date:
(g) Total Estimated Cost of Contract/Order:
(h) Total Fixed-Fee (if applicable):
(i)
¨
Two-Way Match:
¨
Three-Way Match:
(j) Office of Acquisitions:
(k) Central Point of Distribution:
|
||||||
(I) This invoice/financing request represents reimbursable costs for the period from __________ to
|
|||||||
Expenditure Category*
A
|
Cumulative Percentage of Effort/Hrs.
|
Amount Billed
|
Cost at Completion
F
|
Contract
Amount
G
|
Variance
H
|
||
Negotiated
B
|
Actual
C
|
(m)
Current
D
|
(n)
Cumulative
E
|
||||
(o) Direct Costs:
|
|
|
|
|
|
|
|
(1) Direct Labor
|
|
|
|
|
|
|
|
(2) Fringe Benefits
|
|
|
|
|
|
|
|
(3) Accountable Property
|
|
|
|
|
|
|
|
(4) Materials
&
Supplies
|
|
|
|
|
|
|
|
(5) Premium Pay
|
|
|
|
|
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|
|
(6) Consultant Fees
|
|
|
|
|
|
|
|
(7) Travel
|
|
|
|
|
|
|
|
(8) Subcontracts
|
|
|
|
|
|
|
|
(9) Other
|
|
|
|
|
|
|
|
Total Direct Costs
|
|
|
|
|
|
|
|
(p) Cost of Money
|
|
|
|
|
|
|
|
(q) Indirect Costs
|
|
|
|
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|
|
(r) Fixed Fee
|
|
|
|
|
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|
|
(s) Total Amount Claimed
|
|
|
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|
(t) Adjustments
|
|
|
|
|
|
|
|
(u) Grand Totals
|
|
|
|
|
|
|
|
I certify that all payments are for appropriate purposes and in accordance with the contract.
_______________ ____________________________
(Name of Official) (Title)
* Attach details as specified in the contract
|
FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT
Note: Complete this Form in Accordance with Accompanying Instruction
|
Project Task:
|
Contract No.:
|
Date of Report:
|
0990-0134
0990-131 |
|||||
Reporting Period:
|
Contractor Name and Address:
|
||||||||
Expenditure Category
|
Percentage of
Effort/Hours |
Cumulative Incurred Cost at End of Prior Period
|
Incurred Cost--Current Period
|
Cumulative Cost to Date (D + E)
|
Estimated Cost to Complete
|
Estimated Cost at Completion
(F + G) |
Negotiated Contract Amount
|
Variance (Over or Under) (I – H)
|
|
Negotiated
|
Actual
|
||||||||
A
|
B
|
C
|
D
|
E
|
F
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G
|
H
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I
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J
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(1)
|
Key Personnel.
Include key personnel regardless of annual salary rates. All such individuals should be listed by names and job titles on a separate line including those whose salary is not directly charged to the contract but whose effort is directly associated with the contract. The listing must be kept up to date.
|
(2)
|
Personnel-Other.
List as one amount unless otherwise required by the contract.
|
(3)
|
Fringe Benefits.
Include allowances and services provided by the contractor to employees as compensation in addition to regular salaries and wages. If a fringe benefit rate(s) has been established, identify the base, rate, and amount billed for each category. If a rate has not been established, the various fringe benefit costs may be required to be shown separately. Fringe benefits which are included in the indirect cost rate should not be shown here.
|
(4)
|
Accountable Personal Property.
Include nonexpendable personal property with an acquisition cost of $1,000 or more and with an expected useful life of two or more years, and sensitive items regardless of cost. Form HHS 565, “Report of Accountable Property,” must accompany the contractor’s public voucher (SF 1034/SF 1035) or this report if not previously submitted. See “Contractor’s Guide for Control of Government Property.”
|
(5)
|
Supplies.
Include the cost of supplies and material and equipment charged directly to the contract, but excludes the cost of nonexpendable equipment as defined in (4) above.
|
(6)
|
Inpatient Care.
Include costs associated with a subject while occupying a bed in a patient care setting. It normally includes both routine and ancillary costs.
|
(7)
|
Outpatient Care.
Include costs associated with a subject while not occupying a bed. It normally includes ancillary costs only.
|
(8)
|
Travel.
Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure, destination and return, including time and dates; and (iii) Total cost of trip.
|
(9)
|
Consultant Fee.
Include fees paid to consultant(s). Identify each consultant with effort expended, billing rate, and amount billed.
|
(10)
|
Premium Pay.
Include the amount of salaries and wages over and above the basic rate of pay.
|
(11)
|
Subcontracts.
List each subcontract by name and amount billed.
|
(12)
|
Other Costs.
Include any expenditure categories for which the Government does not require individual line item reporting. It may include some of the above categories.
|
(13)
|
Overhead/Indirect Costs.
Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.
|
(14)
|
General and Administrative Expense.
Cite the rate and the base. In the case of nonprofit organizations, this item will usually be included in the: indirect cost.
|
(15)
|
Fee.
Cite the fee earned, if any.
|
(16)
|
Total Costs to the Government.
|
Study Title:
|
|||||
Total Enrollment:
|
Protocol Number:
|
||||
Contract Number:
|
|
||||
PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
|
|||||
Ethnic Category
|
Sex/Gender
|
||||
Females
|
Males
|
Unknown or Not Reported
|
Total
|
||
Hispanic or Latino
|
|
|
|
|
|
Not Hispanic or Latino
|
|
|
|
|
|
Unknown (Individuals not reporting ethnicity)
|
|
|
|
|
|
Ethnic Category: Total of All Subjects*
|
|
|
|
|
|
Racial Categories
|
|||||
American Indian/Alaska Native
|
|
|
|
|
|
Asian
|
|
|
|
|
|
Native Hawaiian or Other Pacific Islander
|
|
|
|
|
|
Black or African American
|
|
|
|
|
|
White
|
|
|
|
|
|
More than one race
|
|
|
|
|
|
Unknown or not reported
|
|
|
|
|
|
Racial Categories: Total of All Subjects*
|
|
|
|
|
|
|
|
|
|
|
|
PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)
|
|||||
Racial Categories
|
Females
|
Males
|
Unknown or Not Reported
|
Total
|
|
American Indian or Alaska Native
|
|
|
|
|
|
Asian
|
|
|
|
|
|
Native Hawaiian or Other Pacific Islander
|
|
|
|
|
|
Black or African American
|
|
|
|
|
|
White
|
|
|
|
|
|
More Than One Race
|
|
|
|
|
|
Unknown or not reported
|
|
|
|
|
|
Racial Categories: Total of Hispanics or Latinos**
|
|
|
|
|
|
*These totals must agree
**These totals must agree |
|
|
|
|
REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY
|
||||||||||||
CONTRACTOR:
|
CONTRACT NUMBER:
|
|||||||||||
ADDRESS:
|
REPORT DATE:
|
|||||||||||
ADDRESS1:
|
|
|||||||||||
ADDRESS2:
|
FISCAL YEAR:
|
|||||||||||
CITY:
|
|
|||||||||||
STATE:
|
||||||||||||
ZIP:
|
|
|
|
|||||||||
CLASSIFICATION
|
BEGINNING OF
PERIOD
|
ADJUSTMENTS
|
END OF PERIOD
|
|||||||||
|
#ITEMS
|
VALUE
|
GFP
ADDED
|
CAP
ADDED
|
DELETIONS
|
#ITEMS
|
VALUE
|
|||||
LAND >=$25K
|
|
|
|
|
|
|
|
|||||
LAND <$25K
|
|
|
|
|
|
|
|
|||||
OTHER REAL >=$25K
|
|
|
|
|
|
|
|
|||||
OTHER REAL <$25K
|
|
|
|
|
|
|
|
|||||
PROPERTY UNDER CONST >=$25K
|
|
|
|
|
|
|
|
|||||
PROPERTY UNDER CONST <$25K
|
|
|
|
|
|
|
|
|||||
PLANT EQUIP >=$25K
|
|
|
|
|
|
|
|
|||||
PLANT EQUIP <$25K
|
|
|
|
|
|
|
|
|||||
SPECIAL TOOLING >=$25K
|
|
|
|
|
|
|
|
|||||
SPECIAL TOOLING <$25K
|
|
|
|
|
|
|
|
|||||
SPECIAL TEST EQUIP >=$25K
|
|
|
|
|
|
|
|
|||||
SPECIAL TEST EQUIP <$25K
|
|
|
|
|
|
|
|
|||||
AGENCY PECULIAR >=$25K
|
|
|
|
|
|
|
|
|||||
AGENCY PECULIAR <$25K
|
|
|
|
|
|
|
|
|||||
MATERIAL >=$25K (CUMULATIVE)
|
|
|
|
|
|
|||||||
PROPERTY UNDER MFR >=$25K
|
|
|
|
|
|
|
|
|||||
PROPERTY UNDER MFR <$25K
|
|
|
|
|
|
|
|
|||||
SIGNED BY:
|
|
|||||||||||
SIGNATURE
|
|
DATE SIGNED:
|
|
|||||||||
NAME PRINTED
|
|
Email
|
|
|||||||||
TITLE
|
|
TELEPHONE
|
|
Actual Cost of Work Performed (ACWP)
|
The costs actually applied and recorded in accomplishing the work performed within a specified period.
|
Actual Direct Cost
|
Those costs identified specifically with a contract, based upon the contractor’s cost identification and accumulation system as accepted by the cognizant DCAA representatives. (See Direct Costs).
|
Advance Agreement (AA)
|
An agreement between the contractor and the Contract Administration Office concerning the application of an approved earned value management system to contracts within the affected facility.
|
Authorized Work
|
That effort which has been authorized and is on contract, or that for which authorized contract costs have not been agreed to but for which written authorization has been received.
|
Baseline
|
(See Performance Measurement Baseline).
|
Budget at Completion (BAC)
|
The sum of all budgets (BCWS) allocated to the contract. Synonymous with the term Performance Measurement Baseline.
|
Budgeted Cost for Work Performed (BCWP)
|
The sum of the budgets for completed Work Packages and completed portions of open Work Packages, plus the appropriate portion of the budgets for level of effort and apportioned effort (Also see Earned Value).
|
Budgeted Cost for Work Scheduled (BCWP)
|
The sum of the budgets for completed Work Packages, planning packages, etc., scheduled to be accomplished (including in-process Work Packages), plus the amount of level of effort and apportioned effort scheduled to be accomplished within a given time period.
|
Internal Replanning
|
Replanning actions performed by the program for remaining effort within the recognized total allocated budget.
|
Level of Effort (LOE)
|
Work that does not result in a final product, e. g., liaison, coordination, follow-up, or other support activities, and which cannot be effectively associated with a definable end product process result. It is measured only in terms of resources actually consumed within a given time period.
|
Management Reserve (MR)
|
An amount of the total Contract Budget Base (CBB) withheld for management control purposes rather than designated for the accomplishment of a specific task or set of tasks. It is not a part of the Performance Measurement Baseline.
|
Negotiated Contract Target Cost
|
The estimated cost negotiated in a Cost Plus Award Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (FPIF) contract.
|
Original Budget
|
The budget established at, or near, the time the contract was signed, based on the negotiated contract cost.
|
Overhead
|
Indirect labor and material, supplies and services costs and other charges, which cannot be consistently identified with individual programs.
|
Other Direct Costs
|
A group of accounting elements which can be isolated to specific tasks, other than labor and material. Included in ODC are such items as travel, computer time, and services
|
Performance Measurement Baseline (PMB)
|
The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management reserve.
|
Performing Organization
|
A defined unit within the program organization structure, which applies the resources to performs the authorized scope of work.
|
Planning Package
|
A logical aggregation of far term work within a Control Account that can be identified and budgeted but not yet defined into Work Packages.
|
Reprogramming
|
Replanning of the effort remaining in the contract, resulting in a new budget allocation which exceeds the contract budget base. The resulting baseline is called an Over Target Baseline (OTB).
|
Responsible Organization
|
A defined unit within program’s organization structure that is assigned responsibility for accomplishing specific tasks.
|
Risk Register
|
Is a tool commonly used in project planning and organizational risk assessments. It is often referred to as a Risk Log. It is used for identifying, analyzing and managing risks.
|
Schedule Performance Index (SPI)
|
An efficiency rating reflecting how quickly or slowly project work is progressing. Measured as a ratio of work accomplished versus work planned for a given period of time. The formula for SPI is BCWP/BCWS.
|
Significant Variances
|
Those differences between planned and actual cost and schedule performance which require further review, analysis, or action. Appropriate thresholds are established as to the magnitude of variances which will require variance analysis.
|
Statistical Estimate at Completion
|
Is a single point estimate that can be quickly prepared and used to test the reasonableness of the current cost estimates and budget and to indicate when a comprehensive EAC should be prepared
|
To-Complete Performance Index (TCPI)
|
An efficiency rating that provides a projection of the anticipated performance required to achieve the EAC. TCPI indicates the future required cost efficiency needed to achieve a target EAC (Estimate At Complete). Any significant difference between TCPI and the CPI needed to meet the EAC should be accounted for by management in their forecast of the final cost.
|
Total Allocated Budget (TAB)
|
The sum of all budgets allocated to the contract. Total allocated budget consists of the performance measurement baseline and all management reserve. The total allocated budget will reconcile directly to the Contract Budget Base (CBB). Any differences will be documented as to quantity and cause.
|
Undistributed Budget (UB)
|
Budget applicable to contract effort which has not yet been identified to WBS elements at or below the lowest level of reporting to the Government.
|
Variance Analysis Report (VAR)
|
The internal report completed by the Control Account Manager and submitted, through the Intermediate Manager, to the program manager for those Control Accounts which have variances in excess of established thresholds.
|
Variances
|
(See Significant Variances).
|
Work Authorization Document (WAD)
|
A form used to formally authorize and budget work to the Control Account Manager. This document must include, as a minimum, the Control Account number, Statement of Work, scheduled start and finish dates, budget, and the identity of the CAM. It must be approved by Intermediate Manager, and be agreed to by the Control Account Manager.
|
Work Breakdown Structure (WBS)
|
A product-oriented, family-tree composed of hardware, software, services, data and facilities which results from system engineering efforts. A work breakdown structure displays and defines the product(s) to be developed and/ or produced and relates the elements of work to be accomplished to each other and to the end product.
(1) Program WBS. The work breakdown structure that covers the acquisition of a specific defense material item and is related to contractual effort. A program work breakdown structure includes all applicable elements consisting of at least the first three levels of the work breakdown structure and extended by the program manager and /or contractor(s). A program work breakdown structure has uniform element terminology, definition, and placement in the family tree structure.
(2) Contract WBS (CWBS) The complete WBS for a contract, developed and used by a contractor within the guidelines of MIL-Handbook 881 (latest revision) or NASA WBS Handbook (insert reference) or other customer guidelines and according to the contract work statement. It includes the approved work breakdown structure for reporting purposes and its discretionary extension to the lower levels by the contractor, in accordance with MIL-Handbook 881 and the contract work statement. It includes all the elements for the products (hardware, software, data, or services) which are the responsibility of the contractor.
|
Work Packages
|
Detailed short-span jobs, or material items, identified by the contractor for accomplishing work required to complete the contract. A Work Package has the following characteristics.
1. It represents units of work at levels where work is performed.
2. It is clearly distinguishable from all other work packages.
3. It is assignable to a single organizational element.
4. It has scheduled start and finish dates and, as applicable, interim milestones, all of which are representative of physical accomplishment.
5. It has a budget or assigned value expressed in terms of dollars, man-hours or other measurable units.
6. Its duration is limited to a relatively short span of time or it is subdivided by discrete value milestones to facilitate the objective measurement of work performed.
7. It is integrated with detailed engineering, manufacturing, or other schedules.
|
Work Package Budgets
|
Resources which are formally assigned by the CAM to accomplish a Work Package, expressed in dollars and/or hours.
|
•
|
EVM Process flows that reflect how a company will build and maintain the EVM system. (EVM Procedures may also be included if the cost associated with them is reasonable)
|
•
|
EVM engine tool and a schedule tool. It is not necessary to load the schedule tool, such as Microsoft Project, with resources. This adds an extra strep, additional costs and little to no value. It is recommended that all resource information be loaded in the EVM engine and leave the schedule tool to what it does best, measure progress through time (duration).
|
•
|
The EVM Engine needs to be integrated with the company’s accounting system.
|
•
|
WBS Dictionary/Control Account Work Authorization Documentation
|
•
|
Integrated Master Schedule
|
•
|
Responsibility Assignment Matrix
|
•
|
Control Account Plans
|
•
|
PMB Log
|
•
|
Baseline Revision Documents
|
•
|
Risk Register
|
•
|
Schedule Status
|
•
|
Integration of accounting data into EVM engine
|
•
|
Run monthly reports for Control Account Managers (Tier 2)
|
•
|
Prepare the monthly Contract Performance Report (CPR) Formats 1 and 5
|
•
|
Run the Control Account Plans for both internal and external (contract requirement for Tier 2 projects)
|
•
|
PMB Change Control
|
Vendor
|
Area of Responsibility
|
Phase Research
|
o Study Documentation Design and Development
o Clinical Monitoring: Includes site initiation, interim, and close-out monitoring visits,
o Pharmacovigilence
o Data Management: Includes build and maintenance of electronic case report forms (eCRFs); data query generation and resolution
o Biostatistics
o Medical Writing:
o Project Management: The Project Manager will actively facilitate Phase Research’s interaction with the research site and provide close monitoring oversight in conjunction with the assigned CRA. Project Management will also assist in the finalization of all applicable study documents and provide coordination between study vendors.
o Pass-through Expenses
Travel for CRA monitoring visits to clinical sites, shipping and printing costs
o Investigator Grants
|
Energetics
|
Core Cardiac Lab
|
TBD
|
Clinical study site(s)
|
Pulse Tech
|
To provide Central Lab services
|
Analyx
|
To perform PK analyses
|
Claritron
|
To write the PK report
|
Obelisk
|
To label and distribute study drug product
|
Joe Josephs
|
Internal Medical Monitor:
Sponsor medical oversight
|
Rolf Xerd
|
Pharmacologist:
Design and analysis consultation for PK parameters and analysis
|
Julie Simms
|
Clinical Trials Manager
|
Phil Thomas
|
Medical Writer
|
Claire Cools
|
SAS Programmer
|
Mary Doe
|
Clinical Contracts
|
Jim Dodds
|
Supply Chain Manager
|
Signed Study Protocol
|
10 %
|
First participant dosed
|
20 %
|
40 % Enrollment
|
35%
|
70% Enrollment
|
50%
|
Last participant procedure (Treatment phase)
|
60 %
|
Last participant follow-up
|
70 %
|
Database lock
|
80 %
|
Clinical Study Report
|
90 %
|
Transferred Trial Master File
|
100 %
|
1.
|
Signed Study Protocol
|
2.
|
Top-line data
|
3.
|
Signed Clinical Study Report
|
1.
|
Top-line Data from an External Clinical Study Identifying Panaceomycin Maximum Tolerated Dose as a single dose in Humans. The Maximum Tolerable Dose will be defined in a study not included in the BARDA contract. This dose will be used in selecting the Supra-therapeutic dose in this Thorough QT Study.
|
2.
|
Successful production of cGMP lot of Panaceomycin.
|
3.
|
Enrollment and retention of study participants.
|
1.
|
Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.
|
2.
|
Identify the status of the covered Federal action.
|
3.
|
Identify the appropriate classification of this report. If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.
|
4.
|
Enter the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.
|
5.
|
If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and zip code of the prime Federal recipient. Include Congressional District, if known.
|
6.
|
Enter the name of the federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard.
|
7.
|
Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.
|
8.
|
Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitations for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned by the Federal agency). Included prefixes, e.g., “RFP-DE-90-001.”
|
9.
|
For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.
|
10.
|
(a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.
|
11.
|
The certifying official shall sign and date the form, print his/her name, title, and telephone number.
|
1.
|
DEFINITIONS 1
|
2.
|
DEVELOPMENT 9
|
3.
|
REGULATORY MATTERS. 10
|
4.
|
COMMERCIALIZATION OF THE LICENSED PRODUCTS 13
|
5.
|
COLLABORATION MANAGEMENT 17
|
6.
|
MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCTS 17
|
7.
|
LICENSES; EXCLUSIVITY 18
|
8.
|
FINANCIAL TERMS 21
|
9.
|
CONFIDENTIALITY AND PUBLICATION 25
|
10.
|
REPRESENTATIONS, WARRANTIES AND COVENANTS 27
|
11.
|
INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE 29
|
12.
|
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND
RELATED MATTERS 31 |
13.
|
TERM AND TERMINATION 36
|
14.
|
MISCELLANEOUS 41
|
1.
|
DEFINITIONS
|
1.1.
|
“
Accounting Standards
” means United States Generally Accepted Accounting Principles (GAAP) or International Financial Reporting Standards (IFRS), in each case as then current at the relevant time and as consistently applied by the applicable Person.
|
1.2.
|
“
Affiliate
”
means, with respect to a Person, any other Person which controls, is controlled by, or is under common control with the applicable Person. For purposes of this definition, “control” shall mean: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction and is sufficient to grant the holder of such voting stock or interest the power to direct the management and policies of such Person) entitled to vote for the election of directors, or otherwise having the power to control or direct the affairs of such Person; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities. Notwithstanding the foregoing, for purposes of this Agreement, Supera Farma Laboratórios S.A., a Brazilian company having a registered address at Avenida das Nações Unidas, 22.532, Bloco 4, Vila Almeida, São Paulo/SP, Brazil shall not be considered an Affiliate of Eurofarma.
|
1.3.
|
“
Calendar Quarter
” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 of each Calendar Year;
provided that
the first Calendar Quarter of the Term shall begin on the Effective Date and end on last day of the Calendar Quarter including the Effective Date and the last Calendar Quarter of the Term shall end on the last day of the Term.
|
1.4.
|
“
Calendar Year
” means each successive period of twelve (12) months commencing on January 1 and ending on December 31;
provided that
the first Calendar Year of the Term shall begin on the Effective Date and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of the Term.
|
1.5.
|
“
Clinical Data
” means data arising from any Clinical Trial of any Licensed Product.
|
1.6.
|
“
Clinical Trial
” means a human clinical trial of a product in any country.
|
1.7.
|
“
Collaboration
” means the collaboration of the Parties in the Development, supply and Commercialization of Licensed Products under this Agreement.
|
1.8.
|
“
Commercialization
”
or
“
Commercialize
”
means any and all activities directed to marketing, promoting, distributing, importing, exporting, offering to sell or selling a product and activities directed to obtaining pricing and reimbursement approvals, as applicable.
|
1.9.
|
“
Commercially Reasonable Efforts
”
means, with respect to a Party, such efforts that are consistent with the efforts and resources normally used by such Party with respect to similar activities conducted on its own behalf, including, with respect to the Development, Manufacture and Commercialization of a Licensed Product, such efforts that are consistent with the efforts and resources normally used by such Party in relation to the Development, Manufacture and Commercialization of a pharmaceutical product or potential pharmaceutical product, as applicable, owned by it or to which it has exclusive rights, which is of similar market potential and at a similar stage in its development or product life as such Licensed Product, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the regulatory structure involved and potential profitability (including pricing and reimbursement status achieved).
|
1.10.
|
“
Competing Product
”
means any antibiotic actively marketed for treatment of
Clostridium difficile
associated diarrhea.
|
1.11.
|
“
Confidential Information
”
means any and all confidential or proprietary information and data, including Summit Know-How and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, that is provided by one Party or any of its Affiliates to the other Party or any of its Affiliates in connection with this Agreement. Summit Know-How is the Confidential Information of Summit. The terms of this Agreement are the Confidential Information of both Parties. All Information disclosed prior to the Effective Date by Summit or any of its Affiliates to Eurofarma or any of its Affiliates pursuant to the Two-Way Confidentiality Agreement by and between the Parties, dated as of October 14, 2015, as amended by Amendment No. 1, dated as of May 23, 2017 (the “
Confidentiality Agreement
”) shall be considered
|
(a)
|
is known by the receiving Party or any of its Affiliates at the time of its receipt from the disclosing Party or any of its Affiliates, and not through a prior disclosure by the disclosing Party or any of its Affiliates, as documented by the receiving Party’s business records;
|
(b)
|
is known to the public before its receipt from the disclosing Party or any of its Affiliates, or thereafter becomes generally known to the public through no breach of this Agreement by the receiving Party or any of its Affiliates;
|
(c)
|
is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party who is not under an obligation of confidentiality to the disclosing Party or any of its Affiliates; or
|
(d)
|
is developed by the receiving Party or any of its Affiliates independently of Confidential Information received from the disclosing Party or any of its Affiliates, as documented by the receiving Party’s business records.
|
1.12.
|
“
Control
,” “
Controls
”
or
“
Controlled by
”
means, subject to Section 14.3, with respect to any Know-How, Patent Rights or other intellectual property rights, the possession of (whether by ownership or license, other than pursuant to this Agreement), and the ability of a Person or its Affiliates to assign, transfer, or grant access to, or to grant a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Person would be required hereunder to assign, transfer or grant another Person such access or license or sublicense;
provided
,
however
,
that
, if a Party obtains rights to any Know-How, Patent Rights or other intellectual property rights through any license agreement with any Third Party, such Party shall only be deemed to “Control” such Know-How, Patent Rights or other intellectual property rights, as applicable, for purposes of this Agreement, if the other Party agrees to be bound by all applicable obligations (other than obligations to make payments) set forth in such license agreement.
|
1.13.
|
“
Cover
,”
“
Covering
”
or
“
Covers
”
means, as to a Licensed Product and Patent Rights, that, in the absence of a license granted under, or ownership of, such Patent Rights, the manufacture, use, offer for sale, sale or importation of such Licensed Product would infringe such Patent Rights assuming the validity and enforceability thereof or, as to a pending claim included in such Patent Rights, the manufacture, use, offer for sale, sale or importation of such Licensed Product would infringe such Patent Rights if such pending claim were to issue in an issued patent.
|
1.14.
|
“
Cumulative Net Sales
” means the aggregate sum of all Net Sales of all Licensed Products during the Term.
|
1.15.
|
“
Development
,”
“
Developing
”
or
“
Develop
”
means, with respect to a Licensed Product, all activities relating to the discovery, evaluation, research and preclinical, non-clinical and clinical development of such Licensed Product prior to or after receiving Regulatory Approval, and all regulatory activities in support of obtaining Regulatory Approval other than activities directed to obtaining pricing and reimbursement approvals.
|
1.16.
|
“
Eurofarma Territory
”
means Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Dominican Republic, Uruguay and Venezuela.
|
1.17.
|
“
Eurofarma Territory Target Enrollment
” means, with respect to the Global Pivotal Clinical Study, [**] Latin American patients enrolled in such Pivotal Clinical Study.
|
1.18.
|
“
Field
”
means all human uses.
|
1.19.
|
“
Finished Drug Product
”
means (i) the finished product formulation of a Licensed Product in bulk tablet form or (ii) the finished product formulation of a Licensed Product in blister packs.
|
1.20.
|
“
First Commercial Sale
”
means, with respect to a Licensed Product in a country, the first sale for end use or consumption of such Licensed Product in such country.
|
1.21.
|
“
Global Pivotal Clinical Study
” means the Pivotal Clinical Studies conducted in both the Eurofarma Territory and the Summit Territory with respect to a Licensed Product.
|
1.22.
|
“
Governmental Authority
”
means any applicable government authority, court, tribunal, arbitrator, agency, department, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any nation, state, province, county, city or other political subdivision thereof or (c) any arbitral or supranational body, including any Governmental Authority involved in granting approvals for the Development, Manufacturing or Commercialization of Licensed Products in or for the Eurofarma Territory.
|
1.23.
|
“
ICH
”
means International Conference on Harmonisation.
|
1.24.
|
“Investigator’s Brochure”
means a compilation of preclinical and clinical data with respect to a new investigational drug that is proposed for filing with an applicable Governmental Authority and used to provide information to clinical investigators and applicable Governmental Authorities.
|
1.25.
|
“
Know-How
”
means all chemical or biological materials and other tangible materials, inventions, improvements, practices, discoveries, developments, data, information, technology, methods, protocols, formulas, knowledge, know-how, trade secrets, processes, assays, skills, experience, techniques and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical data and analytical and quality control data;
provided
,
however
, excluding in any event any Patent Rights.
|
1.26.
|
“
Laws
”
means all applicable laws, statutes, rules, regulations, orders, judgments, injunctions, ordinances or other pronouncements having the binding effect of law of any Governmental Authority.
|
1.27.
|
“
Licensed Product
”
means any product containing Ridinilazole as an active pharmaceutical ingredient.
|
1.28.
|
“
Manufacturing
”
or
“
Manufacture
”
means, as applicable, all activities associated with the production, manufacture, process of formulating, processing, filling, finishing, packaging, labeling, shipping, importing and storage of Licensed Products, including process development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.
|
1.29.
|
“
NDA
”
means a New Drug Application, Marketing Authorization Application or similar application or submission filed with a Governmental Authority in a country or group of countries to obtain marketing approval for a biological, pharmaceutical or other therapeutic or prophylactic product in that country or in that group of countries.
|
1.30.
|
“
Net Sales
”
means the aggregate gross invoiced sales prices from sales of all units of Licensed Products sold by Eurofarma and its Related Parties to independent Third Parties after deducting, if not previously deducted, from the amount invoiced:
|
(a)
|
trade, quantity and cash discounts, credits or allowances actually given;
|
(b)
|
returns, rejections, recalls, rebates, chargebacks, discounts and other credits or allowances actually given;
|
(c)
|
retroactive price reductions or billing corrections;
|
(d)
|
value added, sales and use, excise and other similar taxes and surcharges, customary transportation and insurance, custom duties and other governmental charges, but excluding taxes on net income; and
|
(e)
|
amounts previously included in Net Sales of such Licensed Products that are adjusted or written-off by Eurofarma or its Related Parties as uncollectible in accordance with the standard practices of Eurofarma or its Related Parties for writing off uncollectible amounts consistently applied;
provided that
if any such written-off amounts are subsequently collected, then such collected amounts shall be included in Net Sales in the period in which they are subsequently collected.
|
1.31.
|
“
Party
”
means Eurofarma or Summit.
|
1.32.
|
“
Patent Rights
” means (a) all issued patents (including extensions, restorations by existing or future extension or registration mechanism, including patent term adjustments, patent term extension, supplemental protection certificates or the equivalent thereof, substitutions, confirmations, re-registrations, re-examinations, and patents of addition), (b) patent applications (including all provisional applications, substitutions, requests for continuation, continuations, continuations-in-part, divisionals and renewals), (c) inventor’s certificates and (d) and all equivalents of the foregoing in any country of the world.
|
1.33.
|
“
Person
”
shall mean any natural person, corporation, unincorporated organization, partnership, association, sole proprietorship, joint stock company, joint venture, limited liability company, trust or government, or any agency or political subdivision of any government, or any other similar entity.
|
1.34.
|
“
Pivotal Clinical Study
”
means a Clinical Study of a product that, if pre-specified primary endpoints are met, would demonstrate the safety and efficacy of such product as required to support the Regulatory Approval of such product in an applicable country or territory.
|
1.35.
|
“
Price and Reimbursement Approval
” means the approval, license, registration or authorization of a Governmental Authority to determine or set the price or reimbursement level of a product.
|
1.36.
|
“
Primary Endpoint
” means, with respect to the Global Pivotal Clinical Study, (a) that the Sustained Clinical Response in patients treated with Ridinilazole is shown to be statistically significantly superior to the Sustained Clinical Response in patients treated with vancomycin, in accordance with the statistical analysis plan for the Global Pivotal Clinical Study, or (b) solely to the extent required by any applicable Regulatory
|
1.37.
|
“
Product Trademark(s)
”
means the Trademark(s) for use in connection with the distribution, marketing, promotion and sale of the Licensed Product(s). Product Trademarks specifically excludes the corporate names and logos of the Parties and their Affiliates. Product Trademarks include both the Summit Trademarks and the Eurofarma Trademarks.
|
1.38.
|
“
Promotional Materials
” means written sales, promotion and advertising materials relating to Licensed Products.
|
1.39.
|
“
Regulatory Approval
”
means any and all approvals, licenses, registrations or authorizations of any Governmental Authority that are necessary for the marketing and sale of a product in a country or group of countries.
|
1.40.
|
“
Regulatory Exclusivity
”
means, with respect to a Licensed Product in a country, any exclusive marketing right, data protection or other exclusive right, other than a Patent Right, conferred by any Governmental Authority with respect to such Licensed Product in such country, including new drug exclusivity, new indication or use exclusivity, pediatric exclusivity or orphan drug exclusivity.
|
1.41.
|
“
Related Party
”
means a Party’s Affiliates, permitted Sublicensees and, with respect to Summit, licensees and contractors, but, with respect to Eurofarma, excluding Third Party Distributors.
|
1.42.
|
“
Ridinilazole
” means 2,2'-bis(4-pyridyl)-3H,3'H-5,5'-bibenzimidazole, tetrahydrate, and any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester or prodrug of the foregoing, and intermediates of any of the foregoing
.
|
1.43.
|
“
Sublicensee
”
means a Third Party to whom Eurofarma grants a sublicense under any Summit Technology to Commercialize a Licensed Product in the Field pursuant to Section 7.2.
|
1.44.
|
“
Summit Know-How
”
means Know-How that is Controlled by Summit or its Affiliates during the Term that is reasonably necessary or useful for Eurofarma to Develop or Commercialize Licensed Products in the Field in the Eurofarma Territory.
|
1.45.
|
“
Summit Patent Rights
”
means those Patent Rights that are Controlled by Summit or its Affiliates during the Term that are reasonably necessary or useful to Develop or Commercialize Licensed Products in the Field in the Eurofarma Territory, including the Patent Rights identified on Schedule 1.45.
|
1.46.
|
“
Summit Technology
”
means, collectively, Summit Know-How and Summit Patent Rights.
|
1.47.
|
“
Summit Territory
”
means all countries and territories of the world other than the Eurofarma Territory.
|
1.48.
|
“
Sustained Clinical Response
” means cure of
Clostridium difficile
associated diarrhea at assessment of cure visit, and no recurrence of
Clostridium difficile
associated diarrhea at [**] days after the end of treatment.
|
1.49.
|
“
Tax
” means any present or future taxes, levies, imposts, duties, tariffs, charges, assessments or fees of any nature imposed by a Governmental Authority in the exercise of its taxing power (including interest, penalties and additions thereto).
|
1.50.
|
“
Territory
”
means (a) with respect to Summit, the Summit Territory and (b) with respect to Eurofarma, the Eurofarma Territory.
|
1.51.
|
“
Third Party
”
means an entity other than a Party and its Affiliates.
|
1.52.
|
“
Third Party Distributor
”
means any Third Party appointed by Eurofarma or any of its Related Parties to distribute, market and sell any Licensed Product, with or without packaging rights, in one or more countries in the Eurofarma Territory, in circumstances where such Third Party purchases its requirements of Licensed Product from Eurofarma or its Related Parties for resale but does not (a) make any royalty, milestone or profit share payment to Eurofarma or its Related Parties with respect to its resale of such Licensed Product or (b) assume primary responsibility for advertising, promotion and sales force activities for such Licensed Product in such countries.
|
1.53.
|
“
Trademark
”
means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.
|
1.54.
|
“
United States
”
or
“
U
.
S
.”
means the United States of America and its territories, possessions and commonwealths.
|
1.55.
|
“
Valid Claim
”
means a claim of: (a) an issued and unexpired patent, which claim has not lapsed or been dedicated to the public, withdrawn, cancelled, abandoned, disclaimed, revoked or held unpatentable, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction (which decision is unappealable or has not been appealed within the time allowed for appeal) and which has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise or (b) a patent application that has been pending less than seven (7) years from the date of filing of the earliest patent application from which such patent application claims priority, which claim has not been cancelled, withdrawn or abandoned or finally rejected by an administrative agency action from which no appeal can be taken;
provided
,
however
, that, if any such claim issues after the end of such seven (7) year period, it will upon such issuance again be a Valid Claim subject to clause (a) above.
|
1.56.
|
Additional Definitions
.
Each of the following definitions is set forth in the section of this Agreement indicated below:
|
DEFINITION:
|
SECTION:
|
AAA
|
14.2.2(a)
|
Acquired Party
|
14.3
|
Acquirer
|
14.3
|
Acquirer Program
|
7.6
|
Acquisition
|
14.3
|
Acquisition Party
|
7.5.1
|
Additional CMC Study
|
3.8
|
Agreement
|
Preamble
|
Collaboration Manager
|
5.1
|
Commercial Supply Agreement
|
6.3
|
Competitive Infringement
|
12.3.1
|
Confidentiality Agreement
|
1.11
|
Defense Action
|
12.3.1
|
Effective Date
|
Preamble
|
Eurofarma
|
Preamble
|
Eurofarma Indemnitees
|
11.2
|
Eurofarma Territory Commercialization Plan
|
4.2.1
|
Eurofarma Trademarks
|
12.6.2
|
Global Branding Strategy
|
4.3.1
|
Indemnitee
|
11.4
|
Losses
|
11.1
|
Payee
|
8.8.2
|
Payor
|
8.8.2
|
Pharmacovigilance Agreement
|
3.9
|
Right of Reference
|
3.5.1
|
Summit
|
Preamble
|
Summit Indemnitees
|
11.1
|
Summit Trademarks
|
12.6.1
|
Term
|
13.1
|
2.
|
DEVELOPMENT
|
2.1.
|
Overview
. Summit shall have the exclusive right to Develop Licensed Products;
provided
,
however
, that (a) Eurofarma will use Commercially Reasonable Efforts to assist Summit and each Summit Related Party or Third Party conducting Development of any Licensed Product on behalf of Summit in or for the Eurofarma Territory to identify appropriate centers for the Global Pivotal Clinical Study in the Eurofarma Territory and (b) Eurofarma will be responsible for filing NDAs and interacting with Governmental Authorities in the Eurofarma Territory as described in Section 3.1. For the avoidance of doubt, Summit shall have full control and authority over the Development of the Licensed Products, including by establishing the methods and means by which such Development is conducted.
|
2.2.
|
Global Pivotal Clinical Study
. Within [**] days after the Effective Date, Summit shall provide Eurofarma a high-level plan for the Global Pivotal Clinical Study. Summit shall provide [**] updates to Eurofarma of the progress of its efforts in conducting the Global
|
3.
|
REGULATORY MATTERS
.
|
3.1.
|
Regulatory Filings and Interactions
. Except as otherwise agreed by the Parties in writing, (a) Eurofarma will file with the applicable Governmental Authorities in the Eurofarma Territory all NDAs with respect to Licensed Products and will own such NDAs and all resulting Regulatory Approvals and (b) on a country-by-country and Licensed Product-by-Licensed Product basis in the Eurofarma Territory, beginning on the date that Eurofarma files the first NDA with respect to such Licensed Product in such country, Eurofarma will, as to such Licensed Product in such country, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Governmental Authority, (ii) be responsible for interfacing, corresponding and meeting with each Governmental Authority, (iii) be responsible for maintaining all regulatory filings and (iv) notify Summit in writing, including a brief description in English of the principal issues raised, of all material communications from Governmental Authorities within [**] days, provide Summit with a summary translation of such material communications in English as soon as reasonably possible and provide, if appropriate, a full translation of such material communications in English as soon as reasonably possible thereafter. Eurofarma will provide complete copies of any such original correspondence in their native language to Summit upon request. Eurofarma shall provide Summit with reasonable advance notice of all material, substantive meetings with the Governmental Authorities in the Eurofarma Territory pertaining to any Licensed Products, or with as much advance notice as practicable under the circumstances. Eurofarma shall use Commercially Reasonable Efforts, to the extent reasonably practicable, to permit Summit to have, at Summit’s expense, one (1) mutually acceptable representative of Summit to attend material, substantive meetings with the Governmental Authorities in the Eurofarma Territory pertaining to any Licensed Product. Eurofarma shall furnish Summit with drafts of all copies of Eurofarma’s filings and submissions for Regulatory Approval (including draft NDAs and orphan drug applications and designations) regarding any Licensed Product in the Eurofarma Territory in a timely manner in sufficient time prior to making such filings and submissions to allow Summit a reasonable opportunity to review and comment thereon and shall implement all of Summit’s timely comments. In addition, Eurofarma shall provide Summit with (y) written notice of (i) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Eurofarma Territory in a timely manner and (ii) all Regulatory Approvals obtained or denied for any Licensed Product within [**] days after such event;
provided
,
however
, that in all circumstances, Eurofarma shall inform Summit of such event prior to public disclosure of such event by Eurofarma, and (z) copies of Eurofarma’s filings and submissions for Regulatory Approval (including NDAs and orphan drug applications and designations) regarding any Licensed Product in the Eurofarma Territory within a reasonable period of time after making such filings and submissions.
|
3.2.
|
Regulatory Documentation
. Summit shall provide Eurofarma, to the extent necessary for Eurofarma to fulfill its obligations under Section 3.1, with: (a) a copy of all Clinical Trial protocols and Investigator´s Brochures used in conducting Clinical Trials for the
|
3.3.
|
Product Changes
. Summit shall notify Eurofarma reasonably in advance of any planned changes to any Licensed Product specifications that may materially impact any Regulatory Approval of any Licensed Product that has been granted in the Eurofarma Territory so that Eurofarma may evaluate whether it is necessary to have any such changes submitted to the applicable Governmental Authorities in the Eurofarma Territory.
|
3.4.
|
Due Diligence
.
Upon the completion of the Global Pivotal Clinical Study, the Parties agree that Eurofarma may review the Clinical Data arising out of the Global Pivotal Clinical Study in order to determine whether such Clinical Data support the filing of NDAs for Licensed Products in the Eurofarma Territory.
|
3.5.
|
Rights of Reference
.
|
3.5.1.
|
Grant to Summit
. Eurofarma hereby grants to Summit a “
Right of Reference
,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access and otherwise use, all information and data (including all chemistry, manufacturing and controls information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or early access/named patient programs for the Licensed Products) included in any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) owned or controlled by Eurofarma or its Related Parties that relates to any Licensed Product, in each case in connection with Summit’s or its Related Parties’ (a) Development and Manufacture of Licensed Products throughout the Summit Territory and the Eurofarma Territory and (b) Commercialization of Licensed Products throughout the Summit Territory, and Eurofarma shall provide a signed statement to this effect, if requested by Summit, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Law outside of the United States). Summit may extend the rights granted by Eurofarma to Summit under this Section 3.5.1 to its Related Parties.
|
3.5.2.
|
Grant to Eurofarma
. Summit hereby grants to Eurofarma a Right of Reference to, and a right to copy, access and otherwise use, all information and data (including all chemistry, manufacturing and controls information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or early access/named patient programs for the Licensed Products) included in any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) owned or controlled by Summit or its Related Parties that relates to any Licensed Product, in each case in connection with Eurofarma’s or its Related Parties’ Commercialization of Licensed Products in the Eurofarma Territory, and Summit shall provide a signed statement to this effect, if requested by Eurofarma, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Law outside of the United States), to the extent required for any Eurofarma regulatory filing with respect to any Licensed Product in the Eurofarma Territory. Eurofarma may extend the rights granted by Summit to Eurofarma under this Section 3.5.2 to its Related Parties.
|
3.6.
|
Regulatory Costs
. Eurofarma will be responsible for all costs incurred in connection with Eurofarma’s regulatory activities in support of obtaining any Regulatory Approval for the Licensed Products in the Eurofarma Territory, including the cost of preparing and submitting any NDA with respect to a Licensed Product or interacting with Governmental Authorities with respect to any Regulatory Approvals in the Eurofarma Territory.
|
3.7.
|
Regulatory Timings.
Eurofarma shall use Commercially Reasonable Efforts to file NDAs for Licensed Products in Brazil, Mexico and Argentina within the earlier of (a) [**] months after Summit files the first NDA for a Licensed Product in the Summit Territory or (b) within [**] months after Summit receives Regulatory Approval of the first Licensed Product in the Summit Territory.
|
3.8.
|
Additional CMC Studies; Additional Regulatory Requirements.
Summit shall be responsible for conducting, at its expense, any chemistry, manufacturing and control (CMC) study required by any applicable Governmental Authority in any country in the Eurofarma Territory for the submission of an NDA for any Licensed Product in such country to the extent such study is listed on Exhibit A to this Agreement. If changes in applicable legislation occur in the Eurofarma Territory and any applicable Governmental Authority requests, for any Licensed Product, an additional CMC study not included in Exhibit A (an “
Additional CMC Study
”), the Parties shall discuss in good faith whether to conduct such Additional CMC Study and how to apportion the costs of conducting such Additional CMC Study. Eurofarma shall be responsible for meeting any requirements of any Governmental Authority in any country in the Eurofarma Territory that arise after Regulatory Approval for the first Licensed Product is granted in such country, at Eurofarma’s cost, and Summit shall advise Eurofarma, at Eurofarma´s cost and prior written request, in meeting such post-registration requirements;
provided
,
however
, that Eurofarma may not conduct any Development of any Licensed Product (including any Additional CMC Study of any Licensed Product) without Summit’s prior written consent. If Summit permits Eurofarma to conduct any Development of any Licensed Product in the Eurofarma Territory (including any Additional CMC Study of any Licensed Product), then Eurofarma shall (a) ensure that such Development does not
|
3.9.
|
Pharmacovigilance
.
Within [**] months after the Effective Date, or such later time as may be mutually agreed by the Parties, but in any event prior to the First Commercial Sale of any Licensed Product in the Eurofarma Territory, the Parties will develop and agree in writing upon a pharmacovigilance agreement (“
Pharmacovigilance Agreement
”) that will include safety data exchange procedures governing the coordination of collection, investigation, reporting and exchange of information concerning any adverse experiences and any product quality and product complaints involving adverse experiences related to Licensed Products, sufficient to enable each Party (and its respective Related Parties, if any) to comply with its legal and regulatory obligations. Unless otherwise agreed by the Parties, the Pharmacovigilance Agreement will assign responsibility for maintaining the global safety database for each Licensed Product to Summit and will permit Eurofarma to maintain its own safety database, in addition to the global safety database maintained by Summit, in the Eurofarma Territory. The Pharmacovigilance Agreement will contain terms no less stringent than those required by ICH or other applicable guidelines in order to allow the Parties and their respective Related Parties to meet the applicable regulatory and legal requirements regarding the management of safety data in their respective Territories.
|
4.
|
COMMERCIALIZATION OF THE LICENSED PRODUCTS
|
4.1.
|
Responsibility, Cost and Diligence
. Subject to the terms and conditions of this Agreement, Eurofarma shall be solely responsible, at its expense, for all Commercialization activities relating to Licensed Products in the Field in the Eurofarma Territory. Eurofarma shall use Commercially Reasonable Efforts to Commercialize Licensed Products in each country in the Eurofarma Territory. Summit shall use Commercially Reasonable Efforts to provide Eurofarma with existing information and documents in its Control that are relevant and necessary for Eurofarma to carry out its Commercialization obligations under this Agreement relating to Licensed Products in the Field in the Eurofarma Territory.
|
4.2.
|
Commercialization Plans and Information
.
|
4.2.1.
|
Eurofarma Commercialization Plan
. No less than [**] months in advance of the reasonably expected first Regulatory Approval in the Eurofarma Territory with respect to a Licensed Product, and on [**] basis thereafter, Eurofarma shall prepare and deliver to Summit for review a reasonable written plan that summarizes the Commercialization activities to be undertaken with respect to Licensed Products in the Eurofarma Territory in the next [**] and, to the extent commercially reasonable, Eurofarma’s plans to Commercialize Licensed Products in countries in the Eurofarma Territory in which Eurofarma is not then Commercializing Licensed Products, and the dates by which such activities are targeted to be accomplished (the “
Eurofarma Territory Commercialization Plan
”). The Eurofarma Territory Commercialization Plan shall subsequently be updated and modified by Eurofarma, from time to
|
4.3.
|
Advertising and Promotional Materials
.
|
4.3.1.
|
Global Branding
. Summit shall prepare (and thereafter modify and update at its discretion) a global branding strategy (including global positioning, messages, logo, colors and other visual branding elements) for Licensed Products worldwide (the “
Global Branding Strategy
”).
|
4.3.2.
|
Eurofarma
. Eurofarma will be responsible for the creation, preparation, production, reproduction and filing with the applicable Governmental Authorities, of relevant Promotional Materials for use in the Eurofarma Territory. All such Promotional Materials will be (a) compliant with applicable Law, (b) consistent with the Eurofarma Territory Commercialization Plan and (c) consistent with the Global Branding Strategy. Eurofarma will submit representative samples of its Promotional Materials developed by it for use in the Eurofarma Territory to Summit for its review and discussion at least [**] months prior to the First Commercial Sale of the first Licensed Product in the Eurofarma Territory, and at least [**] thereafter (or more frequently if reasonably requested by Summit). Eurofarma shall consider in good faith any timely comments Summit may have with respect to such Promotional Materials, but, subject to the requirements of Sections 4.3.2(a)-(c), shall have final decision-making authority with respect to such Promotional Materials.
|
4.4.
|
Reporting Obligations
.
Eurofarma shall report to Summit in writing, by no later than each [**] following the first Regulatory Approval of a Licensed Product in the Field in the Eurofarma Territory (for the period ending [**] of the prior [**]), summarizing Eurofarma’s Commercialization activities and resources expended for Licensed Products performed to date (or updating such report for activities performed since the last such report was given hereunder, as applicable).
In addition, Eurofarma shall provide Summit with written notice of the First Commercial Sale of each Licensed Product in the Eurofarma Territory within [**] days after such event;
provided
,
however
, that in all circumstances Eurofarma shall inform Summit of such event prior to public disclosure of such event by Eurofarma.
Eurofarma shall provide such other information to Summit as Summit may reasonably request and shall keep Summit reasonably informed of Eurofarma’s Commercialization activities with respect to Licensed Products.
|
4.5.
|
Sales and Distribution
.
Each Party and its Related Parties shall be responsible for booking sales and shall warehouse and distribute Licensed Products in its Territory. If a Party receives any orders for any Licensed Product in or for the other Party’s Territory, then it shall refer such orders to the other Party. Moreover, each Party and its Related Parties shall be solely responsible for handling all returns of Licensed Products sold in its Territory, as well as all aspects of Licensed Product order processing, invoicing and collection, distribution, inventory and receivables of Licensed Products sold in its Territory.
|
4.6.
|
Recalls, Market Withdrawals or Corrective Actions
.
|
4.6.1.
|
Responsibility.
In the event that any Governmental Authority issues or requests a recall or takes a similar action in connection with Licensed Products in the Eurofarma Territory, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall, market withdrawal or stock recovery of Licensed Products in the Eurofarma Territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall, within [**], and in all cases prior to the execution of such recall, market withdrawal or stock recovery, advise the other Party thereof by telephone, facsimile or e-mail (except in the case of a government mandated recall, when such Party may not provide such advance notice but shall notify the other Party as soon as possible). Eurofarma, in consultation with Summit, shall decide whether to conduct a recall in the Eurofarma Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when Eurofarma may act without such advance consultation but shall notify Summit as soon as possible). Eurofarma shall be responsible for the execution of any such recall in the Eurofarma Territory, and in each such case Summit shall take such actions as reasonably requested by Eurofarma in connection therewith and otherwise reasonably cooperate in all such efforts. Except as otherwise provided in the Commercial Supply Agreement, Eurofarma shall bear the expense of any such recall in the Eurofarma Territory,
provided
,
however
,
that
Summit shall reimburse Eurofarma for the expense (including expenses for importation, logistics, taxes, notification, destruction, and return of the affected Licensed Product and any refund to customers of amounts paid for such Licensed Product) of any such recall in the Eurofarma Territory to the extent such recall is the result of a Manufacturing defect in Licensed Product supplied by (or on behalf of) Summit to Eurofarma. In case of any significant Manufacturing defect of any Licensed Product supplied to Eurofarma by Summit, Summit shall also be responsible for providing Eurofarma with replacement Licensed Product within [**] months, at its own cost and expense. In addition, Summit will make available all of its pertinent records that may be reasonably requested by Eurofarma in order to effect a recall in the Eurofarma Territory.
|
4.6.2.
|
Customer Interactions.
|
4.6.2.1.
|
Eurofarma shall be responsible for negotiating the reimbursement or replacement of any Licensed Product with customers in the Eurofarma Territory in case of recall of any Licensed Product due to technical and/or quality issues. Eurofarma shall deliver to Summit samples of defective (or allegedly defective) Licensed Products supplied by (or on behalf of) Summit to Eurofarma for investigation. Subject to the immediately preceding sentence, Eurofarma may also deliver samples defective (or allegedly defective) Licensed Products to Eurofarma Quality Control, located in Itapevi. Eurofarma Quality Control may contact Summit to request reasonable assistance in Eurofarma’s investigation process, if necessary.
|
4.6.2.2.
|
The Eurofarma call center shall be responsible for contacting applicable customers in the Eurofarma Territory based on the investigative reports created by the Parties’ respective quality control departments.
|
4.6.2.3.
|
In the event of any recall or any similar action related to any Licensed Product in the Eurofarma Territory, Eurofarma shall be responsible for corresponding with customers in the Eurofarma Territory. Summit shall provide reasonable support to Eurofarma with respect to such correspondence, as necessary and as requested by Eurofarma in writing.
|
4.7.
|
Commercial Expenses
.
Except where otherwise specifically set forth in this Agreement, each Party shall bear all costs and expenses incurred in connection with its Commercialization of Licensed Products in its Territory.
|
4.8.
|
Ex-Territory Sales; Export Monitoring
.
|
4.8.1.
|
Ex-Territory Sales
. Subject to applicable Law, neither Party shall engage in any advertising or promotional activities relating to any Licensed Product directed primarily to customers or other buyers or users of such Licensed Product located outside its Territory or accept orders for Licensed Products from or sell Licensed Products into such other Party’s Territory for its own account.
|
4.8.2.
|
Export Monitoring
. Subject to Section 6, each Party and its Related Parties will use Commercially Reasonable Efforts to monitor and prevent exports of Licensed Products from its own Territory for Commercialization in the other Party’s Territory using methods commonly used in the industry for such purpose, and shall promptly inform the other Party of any such exports of Licensed Products from its Territory, and the actions taken to prevent such exports. Each Party agrees to take reasonable actions requested in writing by the other Party that are consistent with Law to prevent exports of Licensed Products from its Territory for Commercialization in the other Party’s Territory.
|
5.
|
COLLABORATION MANAGEMENT
|
5.1.
|
Collaboration Managers
.
Each Party shall designate a Collaboration manager to serve as a primary point of contact for the other Party under the Collaboration (the “
Collaboration Manager
”). Each Party may change its Collaboration Manager at any time in its sole discretion with written notice to the other Party.
|
5.2.
|
Meetings
.
The Parties shall meet to discuss the Collaboration in accordance with a schedule established by mutual written agreement of the Parties, but no less frequently than [**] during the Term, with the location for such meetings alternating between Summit and Eurofarma facilities (or such other locations as are mutually agreed by the Parties). Alternatively, the Parties may meet by means of teleconference, videoconference or other similar communications equipment, but at least [**] shall be conducted in person. Each Party shall bear its own expenses relating to attendance at such meetings by its representatives. At Summit’s written request, Eurofarma agrees to renegotiate this Section 5.2 in good faith to the extent necessary to involve any Summit Related Parties conducting Development, Manufacture or Commercialization of any Licensed Product in the Summit Territory.
|
6.
|
MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCTS
|
6.1.
|
Supply Obligations
.
From and after the Effective Date, subject to the Commercial Supply Agreement once entered into pursuant to Section 6.3, (a) Summit will use Commercially Reasonable Efforts, either itself or through Third Parties, to Manufacture Finished Drug Product meeting all applicable product specifications as filed in the applicable regulatory filings, in accordance with applicable current Good Manufacturing Practices and equivalent Laws outside the United States, including in the Eurofarma Territory, and supply to Eurofarma Finished Drug Product in quantities that are reasonably sufficient for the conduct of Commercialization by Eurofarma with respect to the Eurofarma Territory under the Eurofarma Territory Commercialization Plan and (b) Eurofarma shall purchase the Licensed Product exclusively from Summit and, with respect to Commercialization of Licensed Products in the Eurofarma Territory, Summit shall supply the Licensed Product exclusively to Eurofarma in the Eurofarma Territory during the Term of this Agreement.
|
6.2.
|
Transfer Price.
Beginning with the date on which Summit first supplies Finished Drug Product to Eurofarma pursuant to Section 6.1 until the end of the Calendar Year in which Eurofarma obtains the first Regulatory Approval for a Licensed Product in the Eurofarma Territory, Eurofarma shall pay to Summit an amount equal to [**] U.S. Dollars ($[**]) per tablet of Licensed Product supplied by Summit to Eurofarma in blister packs. At Eurofarma’s written request, Summit shall supply the Licensed Product in bulk tablets, passing to Eurofarma any saving Summit makes through providing in bulk rather than in blisters and using as reference the amount of [**] U.S Dollars ($[**]) per tablet in blister pack. Both Parties shall discuss and agree in good faith on detailed supply conditions in the Commercial Supply Agreement. In each subsequent Calendar Year in which Summit supplies Finished Drug Product to Eurofarma pursuant to Section 6.1, the amount that Eurofarma shall pay to Summit per tablet of Licensed Product shall increase by [**] percent ([**]%) of the amount paid by Eurofarma to Summit per tablet of Licensed Product in the previous Calendar Year. All Finished Drug Product provided by Summit to Eurofarma shall be delivered FOB (Incoterms 2010) to a location identified
|
6.3.
|
Commercial Supply Agreement
.
The Parties will negotiate in good faith and enter into a supply agreement for commercial supply of Licensed Products and a related quality agreement (collectively, the “
Commercial Supply Agreement
”) within [**] months following the Effective Date, which Commercial Supply Agreement will be consistent with the terms set forth in Section 6.1 and Section 6.2 with respect to commercial supply of Licensed Products and will contain other customary terms. When the Parties enter into the Commercial Supply Agreement, the terms of such Commercial Supply Agreement shall supersede the terms set forth in Section 6.1 and Section 6.2. Summit shall provide an initial draft of the Commercial Supply Agreement within [**] months of the signing of this Agreement.
|
6.4.
|
Technology Transfer.
If, at any time during the Term, Summit anticipates or determines that it will not be able to, or anticipates or determines that it will not, continue supplying Eurofarma with Licensed Products for Eurofarma’s Commercialization of Licensed Products in the Eurofarma Territory, Summit shall promptly notify Eurofarma thereof, and the Parties shall negotiate in good faith a plan to transfer from Summit or its applicable Third Party supplier(s) to Eurofarma or its applicable Third Party supplier(s) all Know-How Controlled by Summit or its Affiliates that would be needed for Eurofarma or its applicable Third Party supplier(s) to Manufacture the Licensed Products for Eurofarma’s Commercialization of the Licensed Products in the Field in the Eurofarma Territory.
|
7.
|
LICENSES; EXCLUSIVITY
|
7.1.
|
License Grant to Eurofarma
. Subject to the terms and conditions of this Agreement, Summit hereby grants Eurofarma a non-transferable (except as provided in Section 14.1), sublicensable (subject to Section 7.2), exclusive (even as to Summit) license under the Summit Technology to Commercialize Licensed Products in the Field in the Eurofarma Territory.
|
7.2.
|
Sublicensing Terms
.
|
7.2.1.
|
Permitted Sublicensees
. Subject to the requirements of this Section 7.2, Eurofarma shall have the right to sublicense any of its rights under Section 7.1 to any of its Affiliates or to any Third Party, subject to Summit’s prior written consent.
|
(a)
|
Sublicense Agreements
. Each sublicense granted by Eurofarma pursuant to this Section 7.2 shall be subject and subordinate to the applicable terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement. Eurofarma shall promptly provide Summit with a copy of the fully executed sublicense agreement covering any sublicense granted to an Affiliate or a Third Party hereunder. Without limitation, each sublicense agreement shall contain the following provisions: (i) a requirement that the Sublicensee comply with the confidentiality and non-use provisions of Section 9 with respect to Summit’s Confidential Information, (ii) a requirement that the Sublicensee maintain applicable records and submit applicable sales or other reports to Eurofarma to the extent necessary or relevant to the reports required to be made or records required to be maintained under this Agreement, (iii) a requirement that the Sublicensee comply with the exclusivity obligations set forth in Section 7.4 as though it were an Affiliate of Eurofarma, (iv) an obligation to assign to Summit all improvements to Summit Technology in accordance with Section 12.1, (v) the audit requirements set forth in Section 8.4 and (vi) an obligation to participate in the safety reporting procedures set forth in the Pharmacovigilance Agreement.
|
(b)
|
Sublicensee Breach
. If Eurofarma becomes aware of any material breach of any term of any sublicense by any Eurofarma Sublicensee that interferes with Eurofarma’s compliance with the terms of this Agreement, then Eurofarma shall promptly notify Summit of the particulars of the same and shall use Commercially Reasonable Efforts to cause the Sublicensee to comply with all of the terms of the sublicense agreement necessary for Eurofarma’s compliance with the terms of this Agreement. In the event that (i) the Sublicensee has failed to cure a material breach within [**] days after notice of such breach and (ii) such material breach also constitutes a material breach of this Agreement, Eurofarma shall terminate the sublicense agreement at the request of Summit. Notwithstanding any sublicense, Eurofarma shall remain primarily liable to Summit for the performance of all of Eurofarma’s obligations under, and Eurofarma’s compliance with all terms and conditions of, this Agreement.
|
7.3.
|
No Implied Rights
.
Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any rights or licenses in any Know-How, Patent Rights or other intellectual property rights of the other Party.
|
7.4.
|
Exclusivity
.
During the Term, other than as part of the Collaboration, neither Eurofarma nor any of its Affiliates shall, itself or with or through any Third Party, without the prior written consent of Summit, engage in any Commercialization of any Competing Product in the Eurofarma Territory or the Summit Territory. Likewise, during the Term, other than as part of the Collaboration, neither Summit nor any of its Affiliates shall, itself or with or through any Third Party, without the prior written consent of Eurofarma, engage in any Commercialization of any Competing Product in the Eurofarma Territory.
|
7.5.
|
Competing Product Acquisitions
.
|
7.5.1.
|
Options
. If, during the term of the exclusivity covenant in Section 7.4, a Party or any of its Affiliates acquires a Third Party, or Eurofarma or any of its Affiliates is acquired by a Third Party, (in each case, whether such acquisition occurs by way of a purchase of assets, merger, consolidation or similar transaction) (the Party or Affiliate acquiring or acquired by such Third Party, the “
Acquisition Party
”) and where such Third Party is, at the time of such acquisition, actively Commercializing a Competing Product in a manner that, if performed by the Acquisition Party, would violate Section 7.4, unless the Parties agree otherwise in writing, then the Acquisition Party, or its applicable Affiliate, will (with respect to the applicable Competing Product), at its option and no later than [**] days following the date of consummation of the relevant merger, consolidation or acquisition, notify the other Party in writing of its determination to either:
|
(a)
|
divest, or cause the relevant Affiliate to divest, whether by license or otherwise, its interest in the Competing Product, to the extent necessary to be in compliance with Section 7.4;
|
(b)
|
terminate the Commercialization of the Competing Product, to the extent necessary to be in compliance with Section 7.4; or
|
(c)
|
if the Acquisition Party is Eurofarma, terminate this Agreement pursuant to Section 13.2.1.
|
7.5.2.
|
Divestiture or Termination
. If the Acquisition Party notifies the other Party in writing that it or its relevant Affiliate intends to divest such Competing Product or terminate either this Agreement (if the Acquisition Party is Eurofarma) or the Commercialization of the Competing Product as provided in Section 7.5.1, then the Acquisition Party or its relevant Affiliate will effect the consummation of such divestiture within [**] months or effect such termination within [**] months, subject to compliance with applicable Law (as applicable), after the consummation of the relevant merger, consolidation or acquisition contemplated in Section 7.5.1, and will confirm to the other Party in writing when such divestiture or termination has been completed. The Acquisition Party will keep the other Party reasonably informed of its efforts and progress in effecting such divestiture or termination until it is completed.
|
7.6.
|
Acquirers.
If, during the Term, Summit or any of its Affiliates is Acquired by a Third Party (whether such Acquisition occurs by way of a purchase of assets, merger, consolidation, change of control or otherwise), then, notwithstanding anything to the contrary in Section 7.4, the Third Party acquiring Summit or such Affiliate(s) shall be permitted to conduct activities that would, if performed by Summit or any of its Affiliates, cause Summit or any of its Affiliates to violate Section 7.4 (any such activities, an “
Acquirer Program
”) (and such Acquirer Program will not constitute a violation of Section 7.4);
provided
that (a) none of the Summit Technology is used in such Acquirer Program, (b) no Confidential Information of Eurofarma is used in such Acquirer Program, and (c) the activities required under this Agreement are conducted separately from any activities directed to such Acquirer Program, including by the maintenance of separate lab notebooks and records (password-protected to the extent kept on a computer network) and the use of separate personnel working on each of the activities under this Agreement, and the activities covered under such Acquirer Program (except that this requirement shall not apply to personnel who have senior research management roles and not project level research roles, provided such personnel in senior research management roles are not directly involved in the day-to-day activities under such Acquirer Program).
|
7.7.
|
Government Rights.
Eurofarma understands that Summit Technology may have been or may be developed under a funding agreement with a Governmental Authority and, if so, that a Governmental Authority may have certain rights relative thereto. This Agreement is made subject to any such rights of any Governmental Authority under any such agreement or any applicable Law. In particular (but without limitation), notwithstanding anything to the contrary herein, the rights and licenses granted by Summit to Eurofarma in this Agreement are subject to any such rights of any applicable Governmental Authority. Without limiting the foregoing, Eurofarma acknowledges that, to the extent applicable, the U.S. federal government retains (a) unlimited rights to all government-funded data within the Summit Technology, as set forth in 48 C.F.R. Part 27, Subpart 27.4 and 48 C.F.R. § 52.227-14 and (b) a royalty-free, non-exclusive, non-transferable license to practice or have practiced, and march-in rights with respect to, any government-funded invention within the Summit Technology, as set forth in 48 C.F.R. § 52.227-11 and 35 U.S.C. §§ 200-212, and the regulations promulgated thereunder. Any rights to any such government-funded data or invention(s) granted hereunder, which are greater than permitted by 48 C.F.R. Part 27, Subpart 27.4; 48 C.F.R. § 52.227-14; 48 C.F.R. § 52.245-1; 48 C.F.R. § 52.227-11 or 35 U.S.C. §§ 200-212, as applicable, are subject to modification as required to conform to the provisions of those Laws.
|
8.
|
FINANCIAL TERMS
|
8.1.
|
Upfront Fee
.
In consideration for the exclusive right for Eurofarma to Commercialize the Licensed Products in the Eurofarma Territory under this Agreement, on the Effective Date, Eurofarma shall pay Summit a non-refundable, non-creditable initial payment of Two Million Five Hundred Thousand U.S. Dollars ($2,500,000).
|
8.2.
|
Development Milestone Fees Under License
. Subject to the terms and conditions of this Agreement, in partial consideration for the rights and license granted hereunder,
Eurofarma shall make the non-refundable, non-creditable milestone payments to Summit set forth in TABLE 8.2 below, each payable once, no later than [**] days after the earliest
|
TABLE 8.2: First Licensed Product
|
|
Milestone Event
|
Milestone Payment
|
(i) Achievement of [**] of the Eurofarma Territory Target Enrollment in the Global Pivotal Clinical Study
|
[**]
|
(ii) Achievement of [**] of the Eurofarma Territory Target Enrollment in the Global Pivotal Clinical Study
|
[**]
|
(iii) Achievement of [**] of the Eurofarma Territory Target Enrollment in the Global Pivotal Clinical Study
|
[**]
|
(iv) Achievement of the Primary Endpoint in the Global Pivotal Clinical Study
|
$1,000,000
|
(v) Receipt of Price and Reimbursement Approval for a Licensed Product in [**]
|
$1,200,000
|
(vi) First Commercial Sale of a Licensed Product in [**]
|
[**]
|
(vii) First Commercial Sale of a Licensed Product in [**]
|
[**]
|
8.2.1.
|
Deemed Achievement of Target Enrollment and Primary Endpoint
. If Eurofarma has not paid to Summit a milestone payment set forth in row (iii) of TABLE 8.2, and a milestone event set forth in row (v), (vi) or (vii) of TABLE 8.2 occurs, then, upon the occurrence of such milestone event set forth in such later row, Eurofarma shall pay to Summit the milestone payment set forth in row (iii) of TABLE 8.2. If Eurofarma has not paid to Summit a milestone payment set forth in row (iv) of TABLE 8.2, and a milestone event set forth in row (v), (vi) or (vii) of TABLE 8.2 occurs, then, upon the occurrence of such milestone event set forth in such later row, Eurofarma shall pay to Summit the milestone payment set forth in row (iv) of TABLE 8.2.
|
8.2.2.
|
Events
.
Eurofarma shall provide Summit with written notice of the achievement by Eurofarma or any of its Related Parties of any milestone event set forth in this Section 8.2 within [**] days after such event. Summit shall provide Eurofarma with written notice of the achievement by Summit or any of its Related Parties of any milestone event set forth in this Section 8.2 within [**] days after such event.
|
8.3.
|
Sales Milestone Fees
.
Subject to the terms and conditions of this Agreement, Eurofarma shall make the non-refundable, non-creditable milestone payments to Summit set forth in TABLE 8.3 below, within [**] days after the end of the Calendar Quarter in which the corresponding milestone event has first been achieved by Eurofarma or its Related Parties with respect to Licensed Products in the Eurofarma Territory.
|
TABLE 8.3: Eurofarma Territory Sales Milestone Fees
|
|
Milestone Event
|
Milestone Payment
|
(i) Cumulative Net Sales of Licensed Products in the Eurofarma Territory equal to or greater than $20,000,000
|
$3,000,000
|
(ii) Cumulative Net Sales of Licensed Products in the Eurofarma Territory equal to or greater than $50,000,000
|
$7,500,000
|
(iii) Cumulative Net Sales of Licensed Products in the Eurofarma Territory equal to or greater than $100,000,000
|
$7,500,000
|
(iv) Each subsequent achievement of an additional $100,000,000 Cumulative Net Sales of Licensed Products in the Eurofarma Territory (e.g., $200,000,000; $300,000,000)
|
$7,500,000
|
8.3.1.
|
Reports
. During the Term, following the First Commercial Sale of a Licensed Product in the Eurofarma Territory, Eurofarma shall furnish to Summit a written report within [**] days after the end of each Calendar Quarter showing, on a Licensed Product-by-Licensed Product and country-by-country basis, the gross sales of each Licensed Product in each country of the Eurofarma Territory, deductions from gross sales (itemized by deduction category) for each Licensed Product for each country of the Eurofarma Territory included in the calculation of Net Sales, the Net Sales in each country of the Eurofarma Territory of each Licensed Product during the reporting period and any milestone payments payable under this Agreement.
Eurofarma and its Related Parties shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined.
|
8.4.
|
Audits
.
|
8.4.1.
|
Records; Inspections
. Eurofarma and its Related Parties shall keep complete and accurate records of the items underlying Net Sales, milestones and other payments under this Agreement and shall maintain such records for [**] years after the end of the Calendar Year to which they pertain. Upon the written request of Summit and not more than [**], Eurofarma and its Related Parties shall permit an independent certified public accounting firm of internationally-recognized standing selected by Summit and reasonably acceptable to Eurofarma, at Summit’s expense except as set forth below, to have access during normal business hours to such of the records of Eurofarma and its Related parties as may be reasonably necessary to verify the accuracy of the payments and reports hereunder for any year ending not more than [**] years prior to the date of such request for the sole purpose of verifying the basis and accuracy of payments made under this Agreement. In addition, Eurofarma will provide access to such additional records and information as Summit may reasonably request in order to satisfy Summit’s audit obligations under Summit’s agreements with applicable Third Party funding sources.
|
8.4.2.
|
Discrepancies
. If such accounting firm identifies a discrepancy made during such period, then the appropriate Party shall pay the other Party the amount of the discrepancy (together with, in the case of any underpayments by Eurofarma, late-payment interest in accordance with Section 8.6) within [**] days after the date that both Parties receive the accounting firm’s written report;
provided, however
, that, if a Party objects to such accounting firm’s
|
8.4.3.
|
Confidential Treatment
. Summit shall treat all financial information subject to review under this Section 8.4 or under any sublicense agreement in accordance with the confidentiality and non-use provisions of this Agreement, and Summit undertakes to obtain from any accounting firm conducting any audit of Eurofarma or any of Eurofarma’s Related Parties a reasonable and customary written confidentiality agreement obligating such accounting firm to retain all such information in confidence pursuant to such confidentiality agreement, which terms shall be no less stringent than the provisions of Section 9. Such confidentiality agreement must be forward to Eurofarma.
|
8.5.
|
Payment Exchange Rate
.
Each payment to be made to Summit under this Agreement shall be made in such currency and to such bank account as may be designated in writing by Summit from time to time. All payments to be made under this Agreement to Eurofarma shall be made in US Dollars ($) and shall be paid by bank wire transfer in immediately available funds to such bank account as may be designated in writing by Eurofarma from time to time. If, in a given Calendar Quarter, either Party is required to convert between currencies in order to make a payment or determine whether a payment is due under this Agreement, then such Party shall make such conversion using the conversion rate existing in the United States (as reported in
The Wall Street Journal
, New York edition) for the applicable currency on the last Business Day of the applicable calendar quarter. If
The Wall Street Journal
ceases to publish such exchange rate, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States on which the Parties reasonably agree.
|
8.6.
|
Late Payments
.
Any amount owed by a Party to the other Party under this Agreement that is not paid on or before the date such payment is due shall bear interest at a rate per annum equal to the lesser of (a) the then-current prime rate as published by Citibank, N.A., New York, New York, or any successor thereto, plus [**] percentage points per annum or (b) the highest rate permitted by Law, calculated on the number of days such payments are paid after such payments are due and compounded monthly.
|
8.7.
|
Blocked Payments
.
If, by reason of applicable Laws in any jurisdiction in the Eurofarma Territory, it becomes impossible or illegal for Eurofarma to transfer milestone payments or other payments under this Agreement to Summit, then Eurofarma shall promptly notify Summit. During any such period described above, Eurofarma shall deposit such payments in local currency in the relevant jurisdiction to the credit of Summit in a
|
8.8.
|
Taxes
.
|
8.8.1.
|
Deductions and Withholdings.
Each Party will make all payments to the other Party under this Agreement without deduction or withholding for Taxes except to the extent that any such deduction or withholding is required by applicable Law in effect at the time of payment.
|
8.8.2.
|
Payment.
The full amount of any Tax required to be deducted and withheld within the meaning of Section 8.8.1 on payments under this Agreement will be duly deducted, withheld and timely paid over by the Party making the payment (the “
Payor
”) on behalf of the Party receiving the payment (the “
Payee
”). Any payment payable under this Agreement with respect to which any Tax has been deducted and withheld pursuant to this Section 8.8.2 shall be increased as necessary to ensure that, after all required Tax deductions and withholdings have been made (including with respect to any such increased amount), the net amount received by the Payee (free and clear of any Tax required to be paid over by the Payor with respect thereto to any Governmental Authority) shall be equal to the amount that would have been due to, and received by, the Payee under this Agreement had no such deduction or withholding been required or made.
|
8.8.3.
|
Documentation and Reductions.
The Parties will cooperate with respect to all documentation required by any taxing authority or reasonably required by either Party to secure a reduction in the rate of applicable withholding Taxes.
|
8.8.4.
|
Indemnification.
If (a) the Payor (i) had a duty to deduct, withhold and pay over any Tax to any Governmental Authority in connection with any payment it made to the Payee under this Agreement but (ii) failed to so deduct, withhold and timely pay over all or any portion of such Tax, and (b) such Tax or portion thereof is assessed against the Payee, then the Payor will indemnify and hold harmless the Payee from and against any penalties imposed as a result thereof.
|
9.
|
CONFIDENTIALITY AND PUBLICATION
|
9.1.
|
Nondisclosure Obligation
.
|
9.1.1.
|
Non-Disclosure and Non-Use
. During the Term and for a period of [**] years thereafter, all Confidential Information disclosed by one Party or any of its Affiliates to the other Party or any of its Affiliates hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed to a Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party.
|
9.1.2.
|
Permitted Disclosures
. Notwithstanding the obligations of confidentiality and non-use set forth above, a receiving Party or any of its Affiliates may provide Confidential Information disclosed to it, and disclose the existence
|
9.2.
|
Publication and Publicity
.
|
9.2.1.
|
Publication
. Summit acknowledges Eurofarma’s interest in publishing certain key results of the Collaboration.
Eurofarma recognizes the mutual interest in obtaining valid patent protection and Summit’s interest in protecting its trade secret information.
Consequently, except for disclosures permitted pursuant to Section 9.1 and Section 9.2.3, if Eurofarma wishes to make a publication or public presentation that contains the Confidential Information of Summit or any of Summit’s Affiliates, Eurofarma shall deliver to Summit a copy of the proposed written publication or presentation within [**] days prior to submission for publication or presentation.
Summit shall have the right (a) to propose modifications to the publication or presentation for patent
|
9.2.2.
|
Publicity; Use of Names
. Except as set forth in Section 9.1 and Section 9.2.3, no Party or any of its Affiliates shall use the name, trademark, trade name or logo of the other Party or any of its Affiliates or any of their respective employees in any publicity, news release or disclosure relating to this Agreement without the prior express written permission of the other Party, except as may be required by Law or expressly permitted by the terms hereof.
|
9.2.3.
|
Press Release
. Except as set forth in Section 9.1, neither Party nor any of its Affiliates shall issue press releases or make public disclosures relating to this Agreement or the terms hereof unless mutually agreed by the Parties.
|
10.
|
REPRESENTATIONS, WARRANTIES AND COVENANTS
|
10.1.
|
Mutual Representations and Warranties
.
Each Party represents and warrants to the other Party that as of the Effective Date:
|
10.1.1.
|
It is duly organized and validly existing under the Laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement, and to carry out the provisions hereof.
|
10.1.2.
|
It is duly authorized to execute and deliver this Agreement, and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action.
|
10.1.3.
|
This Agreement is legally binding upon it and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party and by which it may be bound, or with its charter or by-laws.
|
10.1.4.
|
It has not granted any right to any Third Party that would conflict with the rights granted to the other Party hereunder.
|
10.1.5.
|
Neither Party nor any of its Affiliates has been debarred or is subject to debarment pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, as amended, or is the subject of a conviction described in such section.
|
10.2.
|
Additional Representations and Warranties of Summit
. Summit represents and warrants to Eurofarma, as of the Effective Date, that, to Summit’s knowledge as of the Effective Date:
|
10.2.1.
|
Authority
. Summit has sufficient legal or beneficial title and ownership of, or sufficient license rights under, the Summit Technology existing as of the Effective Date to grant the licenses to such Summit Technology granted to Eurofarma pursuant to this Agreement and is the exclusive owner of all Summit Patent Rights set forth in Schedule 1.44.
|
10.2.2.
|
Summit Patent Rights
.
(a) Schedule 1.45 collectively sets forth a complete and accurate list of the Summit Patent Rights existing as of the Effective Date, (b) each issued Summit Patent Right existing as of the Effective Date remains in full force and effect and (c) Summit or its Affiliates have paid all filing and renewal fees required to be paid on or before the Effective Date with respect to such Summit Patent Rights.
|
10.2.3.
|
Completeness of Schedules
.
Other than the Summit Patent Rights set forth on Schedule 1.45, as of the Effective Date Summit does not Control any Patent Rights that Cover any Licensed Product in the Eurofarma Territory.
|
10.2.4.
|
Infringement
.
The Development and Commercialization of Licensed Products in the Eurofarma Territory will not infringe the intellectual property rights of any Third Party. There is (a) no claim, action or proceeding pending, (b) no written communication or (c) no threatened claim, action or proceeding, in each case ((a), (b) and (c)) alleging that the Development or Commercialization of any Licensed Product in the Eurofarma Territory, the activities of Summit or any of its Affiliates with respect to any such Licensed Product in the Eurofarma Territory, or the practice or use of the Summit Patent Rights or Summit Know-How in the Eurofarma Territory, infringes or misappropriates any Patent Rights or other intellectual property of any Third Party. The representation and warranty in the first sentence of this Section 10.2.4 shall apply to actions that Eurofarma may face after the Effective Date.
|
10.3.
|
Additional Representations, Warranties and Covenants of Eurofarma.
Eurofarma represents, warrants and covenants to Summit that Supera Farma Laboratórios S.A (a) is a joint venture partner of Eurofarma involved in the promotion, distribution and marketing of prescription drug products developed by Eurofarma and (b) will not Commercialize any Licensed Product under this Agreement.
|
10.4.
|
Warranty Disclaimer
.
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY, LICENSED PRODUCT, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE LICENSED PRODUCTS PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO THE LICENSED PRODUCTS WILL BE ACHIEVED.
|
10.5.
|
Mutual Covenants
.
|
10.5.1.
|
Non-Contravention
.
During the Term, neither Party, nor any of its Related Parties, will grant any right to any Third Party that would conflict with the rights granted to the other Party hereunder.
|
10.5.2.
|
Compliance with Laws
.
Each Party and its Related Parties shall conduct the Collaboration and the Development, Manufacture and Commercialization of the Licensed Products, as applicable, in accordance with all Laws, including applicable governmental regulations concerning good laboratory practices, good clinical practices and good manufacturing practices.
|
10.5.3.
|
Debarment
.
Neither Party nor any of its Affiliates will use in any capacity, in connection with the Collaboration or the performance of its obligations or exercise of its rights under this Agreement, any Person that has been debarred pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, as amended, or any similar Law outside the United States, including in the Eurofarma Territory, or that is the subject of a conviction described in such section or similar Law, as applicable. Each Party agrees to inform the other Party in writing immediately if it or any Person that is performing activities in the Collaboration or under this Agreement, is debarred or is subject to debarment or is the subject of a conviction described in Section 306 of the United States Federal Food, Drug, and Cosmetic Act, as amended (or any similar Law outside the United States, including in the Eurofarma Territory), or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of the notifying Party’s knowledge, is threatened, relating to the debarment or conviction of the notifying Party or any Person used in any capacity by such Party or any of its Affiliates in connection with the Collaboration or the performance of its obligations or exercise of its rights under this Agreement.
|
11.
|
INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE
|
11.1.
|
General Indemnification by Eurofarma
.
Eurofarma shall indemnify, hold harmless, and defend Summit, its Related Parties, and their respective directors, officers, employees and agents (“
Summit Indemnitees
”) from and against any and all Third Party claims, suits, losses, liabilities, damages, costs, fees and expenses (including reasonable attorneys’ fees and litigation expenses) (collectively, “
Losses
”) arising out of or resulting from, directly or indirectly, (a) any breach of, or inaccuracy in, any representation or warranty made by Eurofarma in this Agreement, or any breach or violation of any covenant or agreement of Eurofarma in or in the performance of this Agreement or (b) the negligence or willful misconduct by or of Eurofarma or its Related Parties, or any of their respective directors, officers, employees and agents, in the performance of Eurofarma’s obligations under this Agreement. Eurofarma shall have no obligation to indemnify the Summit Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, any breach of, or inaccuracy in, any representation or warranty made by Summit in this Agreement, or any breach or violation of any covenant or agreement of Summit in or in the performance of this Agreement, or the negligence or willful misconduct by or on behalf of any of the Summit Indemnitees,
|
11.2.
|
General Indemnification by Summit
.
Summit shall indemnify, hold harmless, and defend Eurofarma, its Related Parties and their respective directors, officers, employees and agents (“
Eurofarma Indemnitees
”) from and against any and all Losses arising out of or resulting from, directly or indirectly, (a) any breach of, or inaccuracy in, any representation or warranty made by Summit in this Agreement, or any breach or violation of any covenant or agreement of Summit in or in the performance of this Agreement or (b) the negligence or willful misconduct by or of Summit or its Related Parties, and their respective directors, officers, employees and agents, in the performance of Summit’s obligations under this Agreement. Summit shall have no obligation to indemnify the Eurofarma Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, any breach of, or inaccuracy in, any representation or warranty made by Eurofarma in this Agreement, or any breach or violation of any covenant or agreement of Eurofarma in or in the performance of this Agreement, or the negligence or willful misconduct by or on behalf of any of the Eurofarma Indemnitees, or matters for which Eurofarma is obligated to indemnify Summit under Section 11.1 or Section 11.3.
|
11.3.
|
Product Liability
.
Any Losses arising out of Third Party product liability claims arising from manufacturing defects in Licensed Products Manufactured by Summit shall be borne by Summit. Any other Losses arising out of Third Party product liability claims arising from Commercialization of Licensed Products shall be (a) borne by Eurofarma, to the extent such Losses were incurred with respect to the Commercialization of the Licensed Products in or for the Eurofarma Territory by or on behalf of Eurofarma or any of its Related Parties and (b) be borne by Summit, to the extent such Losses were incurred with respect to the Commercialization of the Licensed Products in or for the Summit Territory, in each case, by or on behalf of Summit or any of its Related Parties. The Party bearing such Losses in accordance with this Section 11.3 shall indemnify, hold harmless and defend the other Party and its Related Parties and their respective directors, officers, employees and agents from and against such Losses.
|
11.4.
|
Indemnification Procedure
.
In the event of any indemnified claim against any Eurofarma Indemnitee or Summit Indemnitee (individually, an “
Indemnitee
”), the Indemnitee shall promptly notify the other Party in writing of the claim and the indemnifying Party shall manage and control, at its sole expense, the defense of the claim and its settlement;
provided
,
however
, that the indemnifying Party may not settle the claim without the Indemnitee’s prior written consent (not to be unreasonably withheld), if such settlement materially adversely impacts the Indemnitee’s rights or obligations. The Indemnitee shall cooperate with the indemnifying Party and may, at its option and expense, be represented in any such action or proceeding. The indemnifying Party shall not be liable for any settlements, litigation costs or expenses incurred by any Indemnitee without the indemnifying Party’s written authorization. Notwithstanding the foregoing, if the indemnifying Party believes that any of the exceptions to its obligation of indemnification of the Indemnitees set forth in Sections 11.1, 11.2 or 11.3 may apply, then the indemnifying Party shall promptly notify the Indemnitees, who shall then have the right to be represented in any such action or proceeding by separate counsel at their expense;
provided that
the indemnifying Party shall be responsible for payment of such expenses if the Indemnitees are ultimately determined to be entitled to indemnification
|
11.5.
|
Limitation of Liability
.
NEITHER PARTY WILL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF (A) A PARTY’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, (B) A BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN SECTION 9, (C) A BREACH OF SECTION 7.4 OR (D) A BREACH OF SECTION 12.1. NOTHING IN THIS SECTION 11.5 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.
|
11.6.
|
Insurance
.
Eurofarma shall maintain insurance during the Term and until at least two (2) years after the last commercial sale of any Licensed Product in the Eurofarma Territory under this Agreement, with a reputable, solvent insurer in an amount appropriate for Eurofarma’s business and products of the type that are the subject of this Agreement, and for Eurofarma’s obligations under this Agreement. Specifically, Eurofarma shall maintain product liability insurance with limits of [**] U.S. Dollars ($[**]) per occurrence and in annual aggregate. Upon request, Eurofarma shall provide Summit with evidence of the existence and maintenance of such insurance coverage.
|
12.
|
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
|
12.1.
|
Assignment of Improvements
.
Eurofarma hereby assigns and agrees to assign, on behalf of itself and its Related Parties, to Summit all of Eurofarma’s and its Related Parties’ rights, title and interest in and to all Know-How and Patent Rights that (a) are invented, developed or generated on or after the Effective Date by or on behalf of Eurofarma or any of its Related Parties or any Third Party on behalf of or pursuant to contracts with Eurofarma or any of its Related Parties, whether solely or jointly with Summit or any of its Related Parties or any Third Party, and (b) constitute an improvement to any Summit Technology.
|
12.1.1.
|
Disclosure
. Eurofarma shall promptly disclose to Summit any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors during the Term describing any improvement to any Summit Technology. In addition, Eurofarma will disclose to Summit any such information related to such technology, to the extent patentable, necessary for the filing, prosecution or maintenance of any Patent Right claiming or otherwise covering any improvement to any Summit Technology in accordance with the terms and conditions of this Section 12.
|
12.1.2.
|
Employee Assignment Obligations; Third Party Intellectual Property Agreements
. Eurofarma shall ensure that all of its employees, agents and independent contractors and all of its Affiliates’ employees, agents and independent contractors acting under its or its Affiliates’ authority in the performance of this Agreement assign to Eurofarma under a binding written
|
12.1.3.
|
Further Actions and Assignments
. Eurofarma shall take all further actions and execute all assignments that are requested by Summit and reasonably necessary or desirable to vest in Summit the ownership rights set forth in this Section 12.1.
|
12.2.
|
Prosecution and Maintenance of Patent Rights
.
|
12.2.1.
|
Summit Patent Rights
.
|
(a)
|
Responsibility
. Summit has the sole responsibility to, at Summit’s discretion, file, prosecute and maintain all Summit Patent Rights.
Except as required by Law, Summit shall prosecute and maintain Summit Patent Rights that were in existence at the Effective Date and seek issuance of all patent applications within the Summit Patent Rights that were filed in the Eurofarma Territory prior to the Effective Date.
|
(b)
|
Consultation with Eurofarma
. Notwithstanding the foregoing Section 12.2.1(a), Summit shall consult with Eurofarma on the preparation, filing, prosecution and maintenance of all Summit Patent Rights in the Eurofarma Territory. Summit shall furnish Eurofarma with copies of documents relevant to such preparation, filing, prosecution and maintenance in sufficient time prior to filing such document or making any payment due thereunder to allow for review and comment by Eurofarma and shall consider in good faith timely comments from Eurofarma thereon. Summit shall also furnish Eurofarma with copies of all final filings and responses made to any patent authority with respect to all such Patent Rights in a timely manner following submission thereof.
|
12.2.2.
|
Cooperation
.
Eurofarma hereby agrees: (a) to make its employees, agents and consultants reasonably available to Summit (or to Summit’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable Summit to undertake patent prosecution under this Agreement; (b) to cooperate, if necessary and appropriate, with Summit in gaining patent term extensions wherever applicable to Patent Rights under this Agreement and (c) to endeavor in good faith to coordinate its efforts with Summit to minimize or avoid interference with the prosecution and maintenance of Summit’s patent applications. For purposes of clarity, Eurofarma shall not bear any of Summit’s internal or out-of-pocket costs related to Summit’s patents.
|
12.3.
|
Infringement by Third Parties; Defense Actions.
|
12.3.1.
|
Notices
.
Each Party shall promptly report in writing to the other Party any (a) known or suspected infringement of any Summit Technology or (b) unauthorized use or misappropriation of any Confidential Information or Know-How of a Party by a Third Party of which it becomes aware, in each case, to the extent such infringing, unauthorized or misappropriating activities involve, as to a Licensed Product, a competing product in the Field in the Eurofarma Territory ((a) and (b) collectively, “
Competitive Infringement
”), (c) Third Party’s challenge to the validity, scope or enforceability of a Summit Patent Right in the Eurofarma Territory or (d) initiation by a Third Party of any opposition or
inter partes
review proceeding against any Summit Patent Right in the Eurofarma Territory (any challenge or proceeding described in clause (c) or clause (d), a “
Defense Action
”), and shall provide the other Party with all available evidence and information regarding such Competitive Infringement or Defense Action.
|
12.3.2.
|
Rights to Enforce and Defend
.
|
(a)
|
First Right
. Summit shall have the first right, but not the obligation, to initiate an infringement or other appropriate suit or administrative proceeding in the Eurofarma Territory against any Third Party as to any Competitive Infringement in the Eurofarma Territory of any Summit Technology. Summit shall have the sole right, but not the obligation, to defend against any Defense Action in the Eurofarma Territory relating to a Summit Patent Right.
|
(b)
|
Step-In Right
.
If, within [**] days after Summit’s receipt of a notice of a Competitive Infringement in the Eurofarma Territory (or such lesser time so that Eurofarma’s rights are not prejudiced by the delay), Summit does not take any action as described in Section 12.3.2(a) against such Competitive Infringement, then Eurofarma may in its sole discretion, bring and control any legal action in connection with such Competitive Infringement at its sole expense.
|
12.3.3.
|
Procedures; Expenses and Recoveries
.
The Party having the right to initiate or defend any suit, action or administrative proceeding or to challenge any Competitive Infringement under Section 12.3.2 shall have the sole and exclusive right to select counsel for any such suit, action or proceeding and
|
(a)
|
first, to reimburse each Party for all expenses of the suit incurred by the Parties, including attorneys’ fees and disbursements, court costs and other litigation expenses; and
|
(b)
|
second, [**] percent ([**]%) of the balance to be paid to the Party initiating the suit and [**] percent ([**]%) of the balance to be paid to the other Party.
|
12.3.4.
|
Settlement.
Neither Party will enter into any settlement of any an infringement or other appropriate suit or administrative proceeding against a Competitive Infringement that could reasonably be expected to (a) have a material adverse effect on any Summit Technology in the Eurofarma Territory (including by way of any admission of invalidity or unenforceability of any Summit Technology) or (b) materially adversely affect the other Party’s rights or interests without such other Party’s written consent, which consent will not be unreasonably withheld.
|
12.4.
|
Common Interest
.
All information exchanged between the Parties’ representatives regarding the preparation, filing, prosecution, maintenance, enforcement or defense of the Patents Rights under this Section 12 will be deemed Confidential Information of each applicable disclosing Party (subject to Sections 1.11(a), 1.11(b), 1.11(c) and 1.11(d)). In addition, the Parties acknowledge and agree that, with regard to such preparation, filing, prosecution, maintenance and enforcement of the Patents Rights under this Section 12, the interests of the Parties as collaborators and licensor and licensee are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The Parties agree and acknowledge that they have not waived, and nothing
|
12.5.
|
Third Party Infringement Claims.
If a Third Party sues a Party alleging that the sued Party’s, or the sued Party’s Related Parties’, Development, Manufacture or Commercialization of a Licensed Product in the Eurofarma Territory infringes or will infringe said Third Party’s intellectual property, then upon the sued Party’s request and in connection with the sued Party’s defense of any such Third Party suit, the other Party will provide reasonable assistance to the sued Party for such defense at no charge to the sued Party except for reimbursement by the sued Party of reasonable out-of-pocket costs incurred in rendering such assistance. The sued Party will keep the other Party, if such other Party has not joined in such suit, reasonably informed regarding such suit on a quarterly basis, in person or by telephone, prior to and during the pendency of any such suit.
|
12.6.
|
Trademarks
.
|
12.6.1.
|
Summit Trademarks
. Summit (or its Related Parties, as appropriate) shall own all rights to the Product Trademark(s) developed or used by Summit with respect to the Commercialization of Licensed Products in the Summit Territory (the “
Summit Trademarks
”), and all goodwill associated therewith, throughout the Summit Territory and the Eurofarma Territory. Summit shall also own rights to any Internet domain name incorporating the applicable Summit Trademarks or any variation or part of such Summit Trademarks as its URL address or any part of such address. Neither Eurofarma nor any of its Related Parties shall use any Summit Trademarks without Summit’s prior written consent.
|
12.6.2.
|
Eurofarma Trademarks
.
Eurofarma will develop and propose for Summit’s review, which shall not be unreasonably withheld, one or more Product Trademark(s) for use by Eurofarma and its Related Parties throughout the Eurofarma Territory. Such Product Trademark(s) shall be consistent with the Global Branding Strategy. Summit shall use Commercially Reasonable Efforts to review any Product Trademark proposed by Eurofarma within [**] business days after Summit’s receipt of such proposed Product Trademark. Any Product Trademark(s) (other than the Summit Trademarks that Summit permits Eurofarma to use) used by Eurofarma to Commercialize Licensed Products in the Eurofarma Territory are hereinafter referred to as the “
Eurofarma Trademarks
.” In case there is no response in [**] business days, Eurofarma will consider that Trademarks are reviewed. Eurofarma (or its Related Parties, as appropriate) shall own all rights to Eurofarma Trademarks and all goodwill associated therewith, throughout the Eurofarma Territory and Summit Territory. Eurofarma shall also own rights to any Internet domain name incorporating the applicable Eurofarma Trademarks or any variation or part of such Eurofarma Trademarks as its URL address or any part of such address.
Neither Summit nor its Related Parties shall use any Eurofarma Trademarks to Commercialize any Licensed Product in the Summit Territory.
|
12.6.3.
|
Product Trademark Infringement
.
In the event either Party becomes aware of any infringement of any Product Trademark by a Third Party, such Party shall promptly notify the other Party.
|
12.6.4.
|
Use of Names
.
For the avoidance of doubt, except as otherwise required by Laws or agreed by the parties in advance in writing, neither Party shall have any right to use the other Party’s or the other Party’s Related Parties’ corporate names or logos in connection with Commercialization of Licensed Products.
|
13.
|
TERM AND TERMINATION
|
13.1.
|
Term.
This Agreement shall be effective as of the Effective Date and, unless terminated earlier pursuant to Section 13.2, this Agreement shall continue in effect until the latest of (a) the earliest date on which there are no Valid Claims of any Summit Patent Rights Covering any Licensed Product in the Eurofarma Territory, (b) the earliest date on which there is no Regulatory Exclusivity for any Licensed Product in the Eurofarma Territory and (c) the tenth (10
th
) anniversary of the First Commercial Sale of the first Licensed Product in the Eurofarma Territory (“
Term
”). Upon expiration of the Term, (x) all licenses granted to Eurofarma under Section 7.1 then in effect shall become fully paid-up, perpetual, irrevocable licenses and (y) the Parties shall discuss in good faith whether, and on what terms, to continue their relationship under any Commercial Supply Agreement then in effect.
|
13.2.
|
Termination Rights
.
|
13.2.1.
|
Termination for Convenience
.
At any time after Eurofarma has paid to Summit all of the milestone payments set forth in Sections 8.2(i)-(iv), Eurofarma shall have the right to terminate this Agreement in its entirety on six (6) months’ prior written notice to Summit.
|
13.2.2.
|
Termination for Cause
.
|
(a)
|
Termination for Insolvency.
In the event that either Party makes an assignment for the benefits of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which petition is not discharged within sixty (60) days of the filling thereof, then the other Party may terminate this Agreement effective immediately upon written notice to such Party.
|
(b)
|
Termination for Breach.
Either Party may terminate this Agreement, effective immediately upon written notice to the other Party, for any material breach by the other Party of any term of this Agreement that remains uncured for [**] days
after the non-breaching Party gives written notice to the other Party of such breach and its intent to terminate this Agreement if such breach is not cured.
|
(c)
|
Termination for Lack of Efficacy.
Eurofarma may terminate this Agreement, effective immediately upon written notice to Summit, within thirty (30) days following receipt of analysis from Summit of the Global Pivotal Clinical Study which analysis fails to show achievement of the Primary Endpoint. For purposes of clarity, the milestone that refers to the Achievement of the Primary Endpoint in the Global Pivotal Clinical Study (Milestone event iv) shall not be payable by Eurofarma if this Agreement is terminated pursuant to this Section 13.2.2(c).
|
(d)
|
Termination due to Lack of Pricing Approval.
Eurofarma shall use Commercially Reasonable Efforts to promptly notify Summit on the receipt of Price and Reimbursement Approval and to keep Summit updated regarding the entire process, in the Eurofarma Territory. Eurofarma may terminate the Agreement effective immediately upon written notice to the other Party within thirty (30) days after Price and Reimbursement Approval is granted by the applicable Regulatory Authorities in [**] for the first Licensed Product if such Price and Reimbursement Approval is not economically viable. For purposes of clarity, the milestone that refers to the Receipt of Price and Reimbursement Approval for a Licensed Product in [**] (Milestone event v) shall not be payable by Eurofarma if such Price and Reimbursement Approval is not economically viable and because of that this Agreement is terminated by Eurofarma pursuant to this Section 13.2.2(d).
|
(e)
|
Termination due to Transfer Price
. In the event it is proven by Eurofarma to Summit that the price charged by Summit to Eurofarma for Licensed Products is no longer economically feasible to Eurofarma due to exchange rate changes or a significant rise in the cost of raw materials or a significant change in any applicable market that could significantly impact the Commercialization of the Licensed Products in the Eurofarma Territory, both Parties shall use Commercially Reasonable Efforts to discuss and agree on a financially viable solution for both Parties. If both Parties do not reach an agreement within [**] days, Eurofarma may, within thirty (30) days after such failure to reach agreement, terminate the Agreement effective immediately upon written notice to Summit.
|
(f)
|
Termination due to Non-Granting of Patent Rights in [**]
. At Eurofarma’s option, Eurofarma may terminate this Agreement within thirty (30) days after all claims in all Summit Patent Rights pending in [**] as of the Effective Date are finally rejected by an administrative agency action from which no appeal can be taken, provided that such rejection materially affects the Commercialization of the Licensed Products in the Eurofarma Territory. For purposes of clarity, Summit has attached to this Agreement as Schedule 1.44 the Summit Patent Rights that exist as of the Effective Date.
|
(g)
|
Termination for Infringement.
Eurofarma may terminate this Agreement within thirty (30) days after receipt of any claim that the use of Summit Know How and any of Summit Patent Rights infringe any Third Party Patent Rights.
|
(h)
|
Termination due to Regulatory Matters
. Eurofarma shall use Commercially Reasonable Efforts to promptly notify Summit on the approval or the non-approval of each Licensed Product by any Governmental Authority in the Eurofarma Territory. Eurofarma may terminate this Agreement upon written notice to the other Party within thirty (30) days after (i) the date an application for approval for the Licensed Product is rejected by any Governmental Authority in [**] and (ii) an applicable Governmental Authority in [**] requests additional studies that are proven by Eurofarma to Summit not to be economically feasible to either Party.
|
(i)
|
Challenges of Patent Rights
. In the event that Eurofarma or any of its Related Parties (i) commences or participates in any action or proceeding (including any patent opposition or re-examination proceeding), or otherwise asserts any claim, challenging or denying the validity or enforceability of any Summit Patent Right or any claim thereof or (ii) actively assists any other Person in bringing or prosecuting any action or proceeding (including any patent opposition or re-examination proceeding) challenging or denying the validity or enforceability of any Summit Patent Right or any claim thereof, then (A) Eurofarma shall give notice thereof to Summit within [**] days of taking such action (or becoming aware that its Related Party has taken such action) and (B) Summit will have the right, in its sole discretion to give notice to Eurofarma that the licenses granted to Eurofarma with respect to all or any portion of the Summit Patent Rights licensed to Eurofarma under this Agreement will terminate thirty (30) days following such notice (or such longer period as Summit may designate in such notice) unless (1) Eurofarma withdraws or causes to be withdrawn all such challenges or (2) in the case of
ex-parte
proceedings, multi-party proceedings or other patent challenges that Eurofarma or Eurofarma’s Related Parties do not have the power to unilaterally withdraw or cause to be withdrawn, Eurofarma and Eurofarma’s Related Parties cease assisting any other party to such patent challenge and, to the extent Eurofarma or any Eurofarma Related Party is a party to such patent challenge, withdraw from such patent challenge, in each case, within such thirty (30)-day period. In the event that Summit is not permitted under Law to terminate the licenses with respect to all Summit Patent Rights under this Agreement, then the Parties agree to construe this provision to permit Summit to terminate only the licenses to that portion of such Summit Patent Rights with respect to which Summit may terminate consistent with applicable Law.
|
13.3.
|
Effect of Termination.
Without limiting any other legal or equitable remedies that either Party may have:
|
13.3.1.
|
Effect of Any Termination
. Upon any termination of this Agreement:
|
(a)
|
all license grants in this Agreement from Summit to Eurofarma shall immediately terminate; and
|
(b)
|
at Summit’s option, Eurofarma shall as promptly as practicable transfer to Summit or Summit’s designee (i) possession and ownership of all governmental or regulatory correspondence, conversation logs, filings and approvals (including all NDAs, Regulatory Approvals and Pricing and Reimbursement Approvals) relating to the Development, Manufacture or Commercialization of any Licensed Product and all Eurofarma Trademarks used for any Licensed Product in the Field in the Eurofarma Territory (but not any Eurofarma house marks or any trademark containing the word “Eurofarma” owned by Eurofarma and used for any Licensed Product in the Field in the Eurofarma Territory), (ii) copies of all data, reports, records and materials, and other sales and marketing related information in Eurofarma’s possession or Control to the extent that such data, reports, records, materials or other information relate to the Development, Manufacture or Commercialization of any Licensed Product, including all non-clinical and clinical data relating to any Licensed Product, and customer lists and customer contact information and all adverse event data in Eurofarma’s possession or Control, and Eurofarma shall use Commercially Reasonable Efforts to obtain for Summit the right to access all such data, reports, records, materials and other sales and marketing related information, and (iii) all records and materials in Eurofarma’s possession or Control containing Confidential Information of Summit.
Eurofarma shall further appoint Summit as Eurofarma’s or Eurofarma’s Related Parties’ agent for all Licensed Product-related matters involving Governmental Authorities in the Eurofarma Territory until all Regulatory Approvals and other regulatory filings have been transferred to Summit or its designee.
|
13.3.2.
|
Effect of Termination by Eurofarma for Convenience or Cause or by Summit for Cause
. Upon any termination of this Agreement by Eurofarma pursuant to Section 13.2.1 or Section 13.2.2 or by Summit pursuant to Section 13.2.2:
|
(a)
|
Payment
. Eurofarma shall pay to Summit all payment obligations that accrued prior to the effective date of termination, to the extent they have not previously been paid. For purposes of clarity, with respect to milestone payments, this Section 13.3.2(a) shall only require Eurofarma to pay Summit for the milestones achieved by the time of the termination of this Agreement and not all the milestone payment obligations contemplated in this Agreement.
|
(b)
|
Appointment as Distributor
. At Summit’s option, if the effective date of termination is after the First Commercial Sale of a Licensed Product in the Eurofarma Territory, then Eurofarma shall appoint Summit as its exclusive distributor of all Licensed Products in the Eurofarma Territory and grant Summit the right to appoint sub-distributors, until such time as all applicable Regulatory Approvals in the Eurofarma Territory have been transferred to Summit or its designee.
|
(c)
|
Third Party Agreements
.
At Summit’s option, and to the extent permitted under Eurofarma’s obligations to Third Parties at the time of termination, Eurofarma shall transfer to Summit any Third Party agreements relating solely and exclusively to the Development or Commercialization of any Licensed Product to which Eurofarma is a party, subject to any required consents of such Third Party, which Eurofarma shall use Commercially Reasonable Efforts to obtain promptly.
|
(d)
|
Further Assistance
.
Eurofarma shall provide any other assistance reasonably requested by Summit for the purpose of allowing Summit or its designee to proceed expeditiously with the Development, Manufacture and Commercialization of Licensed Products in the Eurofarma Territory. Eurofarma shall execute all documents and take all such further actions as may be reasonably requested by Summit in order to give effect to the foregoing clauses.
|
13.3.3.
|
Effect of Termination by Eurofarma for Convenience or by Summit for Cause
. Upon any termination of this Agreement by Eurofarma pursuant to Section 13.2.1 or by Summit pursuant to Section 13.2.2, in the event that any Licensed Product is already under commercialization, Eurofarma shall pay to Summit within [**] days after the effective date of such termination, a
pro rata
share of the next Eurofarma Territory sales milestone payment that would have been due to Summit pursuant to Section 8.3 if this Agreement had not been terminated. By way of example, and not limitation, if, as of the effective date of termination of this Agreement, Eurofarma has made Cumulative Net Sales of Licensed Products in the Eurofarma Territory of Two Hundred Fifty Million Dollars ($250,000,000) and has paid to Summit all payments that accrued under this Agreement prior to such effective date of termination, then Eurofarma shall also pay to Summit Three Million Seven Hundred Fifty Thousand U.S. Dollars ($3,750,000), which is equal to fifty percent (50%) of the Seven Million Five Hundred Thousand U.S. Dollars ($7,500,000) milestone payment that Eurofarma would have owed to Summit under Section 8.3 for achievement of Three Hundred Million U.S. Dollars ($300,000,000) in Cumulative Net Sales (since Fifty Million U.S. Dollars ($50,000,000) is fifty percent (50%) of One Hundred Million U.S. Dollars ($100,000,000)). Eurofarma shall thereafter cease to have any financial obligations under this Agreement.
|
13.4.
|
Effect of Expiration or Termination; Survival
.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. The provisions of Sections 1, 3.5.1, 7.3, 7.7, 8.4, 8.5, 8.6, 8.7, 8.8, 9.1, 9.2.1, 9.2.2, 10.4, 11, 12.1, 13.3, 13.4 and 14 shall survive any expiration or termination of this Agreement. Except as otherwise set forth in this Section 13, upon termination or expiration of this Agreement all rights and obligations of the Parties under this Agreement shall cease.
|
14.
|
MISCELLANEOUS
|
14.1.
|
Assignment
.
Except as provided in this Section 14.1, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the written consent of the other Party. However, either Party may, without the other Party’s written consent, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate of the assigning Party or to a party that acquires, by or otherwise in connection with a merger, sale of assets or otherwise, all or substantially all of the business of the assigning Party to which the subject matter of this Agreement relates. The assigning Party shall remain responsible for the performance by its assignee of this Agreement or any obligations hereunder so assigned. Any purported assignment in violation of this Section 14.1 shall be null, void and of no legal effect.
|
14.2.
|
Governing Law; Arbitration
.
|
14.2.1.
|
Governing Law
. This Agreement shall be construed and the respective rights of the Parties determined in accordance with the substantive Laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the Law of another jurisdiction, and the patent Laws of the relevant jurisdiction without reference to any rules of conflict of laws.
|
14.2.2.
|
Arbitration
. Any dispute arising out of or relating to this Agreement shall be resolved through binding arbitration as follows:
|
(a)
|
A Party may submit such dispute to arbitration by notifying the other Party, in writing, of such dispute. Within [**] days after receipt of such notice, the Parties shall designate in writing a single arbitrator to resolve the dispute;
provided
,
however
, that if the Parties cannot agree on an arbitrator within such [**]day period, then the arbitrator shall be selected by the Boston, Massachusetts office of the American Arbitration Association (the “
AAA
”). The arbitrator shall not be a current or former Affiliate, employee, consultant, officer, director or stockholder of any Party.
|
(b)
|
Within [**] days after the designation of the arbitrator, the arbitrator and the Parties shall meet, at which time the Parties shall be required to set forth in writing all disputed issues and a proposed ruling on the merits of each such issue.
|
(c)
|
The arbitrator shall set a date for a hearing, which shall be no later than [**] days after the submission of written proposals pursuant to Section 14.2.2(b), to discuss each of the issues identified by the Parties. The Parties shall have the right to be represented by counsel. Except as provided herein, the arbitration shall be governed by the Commercial Arbitration Rules of the AAA;
provided
,
however
, that the Federal Rules of Evidence shall apply with regard to the admissibility of evidence and the arbitration shall be conducted by a single arbitrator.
|
(d)
|
The arbitrator shall use his or her best efforts to rule on each disputed issue within [**] days after the completion of the hearings described in Section 14.2.2(c). The determination of the arbitrator as to the resolution of any dispute shall be binding and conclusive upon all Parties. All rulings of the arbitrator shall be in writing and shall be delivered to the Parties.
|
(e)
|
The attorneys’ fees of the Parties in any arbitration, fees of the arbitrator, and costs and expenses of the arbitration shall be borne by the Parties as determined by the arbitrator.
|
(f)
|
Any arbitration pursuant to this Section 14.2.2 shall be conducted in English in Boston, Massachusetts, U.S. Any arbitration award may be entered in and enforced by any court of competent jurisdiction.
|
(g)
|
Nothing in this Section 14.2.2 shall be construed as limiting in any way the right of a Party to seek an injunction or other equitable relief with respect to any actual or threatened breach of this Agreement or to bring an action in aid of arbitration. Should any Party seek an injunction or other equitable relief, or bring an action in aid of arbitration, then for purposes of determining whether to grant such injunction or other equitable relief, or whether to issue any order in aid of arbitration, the dispute underlying the request for such injunction or other equitable relief, or action in aid of arbitration, may be heard by the court in which such action or proceeding is brought.
|
14.3.
|
Acquisitions.
Each Party agrees that, in the event that a Party (the “
Acquired Party
”) is acquired (whether by way of merger, acquisition, sale of all or substantially all of its business or assets to which this Agreement pertains, or otherwise) (an “
Acquisition
”) by a Third Party (the “
Acquirer
”), the Acquired Party shall be deemed not to “Control” for purposes of this Agreement and the other Party shall not obtain any rights or access under this Agreement to, any Know-How or Patent Rights owned by or licensed to such Acquirer, or any of such Acquirer’s Affiliates that were not Affiliates of the Acquired Party immediately prior to the consummation of such Acquisition.
|
14.4.
|
Entire Agreement; Amendments
.
This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof, and supersedes all previous arrangements with respect to the subject matter hereof, whether written or oral, including the Confidentiality Agreement. This Agreement (including the Exhibits and Schedules hereto) may be amended, or any term hereof modified, only by a written instrument duly-executed by authorized representatives of both Parties.
|
14.5.
|
Severability
.
If any provision hereof should be held invalid, illegal or unenforceable in any respect in any jurisdiction, then the Parties shall substitute, by mutual consent, valid provisions for such invalid, illegal or unenforceable provisions, which valid provisions in their economic effect are sufficiently similar to the invalid, illegal or unenforceable provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions. In case such valid provisions cannot be agreed upon, the invalidity, illegality or unenforceability of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid, illegal or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without such invalid, illegal or unenforceable provisions.
|
14.6.
|
Headings
.
The captions to the Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Sections hereof.
|
14.7.
|
Waiver of Rule of Construction
.
Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
|
14.8.
|
Interpretation
.
Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes”, “including” and “
e.g.
” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall,” (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any Person shall be construed to include the Person’s successors and permitted assigns, (f) the words “herein”, “hereof” and “hereunder,” and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections, Exhibits or Schedules shall be construed to refer to Sections, Exhibits or Schedules of this Agreement, and references to this Agreement include all Exhibits and Schedules hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any
|
14.9.
|
No Implied Waivers; Rights Cumulative
.
No failure on the part of Summit or Eurofarma to exercise, and no delay in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at Law or in equity or otherwise, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.
|
14.10.
|
Notices
.
All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
|
If to Summit, to:
|
136a Eastern Avenue
Milton Park, Abingdon
Oxfordshire, OX14 4SB
United Kingdom
Attention: Chief Executive Officer
|
With a copy to:
|
136a Eastern Avenue
Milton Park, Abingdon
Oxfordshire, OX14 4SB
United Kingdom
Attention: Company Secretary
WilmerHale LLP
60 State Street
Boston, MA 02109
Attention:
Steven D. Barrett, Esq.
|
If to Eurofarma, to:
|
Avenida Vereador José Diniz, 3465
04603-0003 – São Paulo, SP, Brazil
Attention: Emilio Maganha Neto
|
With a copy to:
|
Avenida Vereador José Diniz, 3465
04603-0003 – São Paulo, SP, Brazil
Attention: Portfolio Management & Licensing
|
14.11.
|
Compliance with Export Regulations
.
Neither Party shall export any technology licensed to it by the other Party under this Agreement except in compliance with all applicable export Laws and regulations.
|
14.12.
|
Force Majeure
.
Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods or other acts of God. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.
|
14.13.
|
Independent Contractors
.
It is expressly agreed that Summit and Eurofarma shall be independent contractors and that the relationship between Summit and Eurofarma shall not constitute a partnership, joint venture or agency. Summit shall not have the authority to make any statements, representations or commitments of any kind, or to take any action, that would be binding on Eurofarma, without the prior written consent of Eurofarma, and Eurofarma shall not have the authority to make any statements, representations or commitments of any kind, or to take any action, that would be binding on Summit without the prior written consent of Summit.
|
14.14.
|
Counterparts
.
The Agreement may be executed in two or more counterparts, including by facsimile or PDF signature pages, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
|
14.15.
|
Binding Effect; No Third Party Beneficiaries
.
As of the Effective Date, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and permitted assigns. Except as expressly set forth in this Agreement, no Person other than the Parties and their respective Affiliates and permitted assignees hereunder shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.
|
EUROFARMA LABORATÓRIOS S.A.
|
EUROFARMA LABORATÓRIOS S.A.
|
BY:
/s/ Emilio Maganha
NAME: Emilio Maganha
TITLE: Director Gestão Portfolio e Licenças
|
BY:
/s/ Martha Penna
NAME: Martha Penna
TITLE: Vice Presidente Inovação
|
|
|
SUMMIT (OXFORD) LTD
|
|
BY:
/s/ Glyn Edwards
NAME: GLYN EDWARDS
TITLE: CEO
|
20
th
December 2017
|
|
|
Witness
:
|
Witness
: SUMMIT (OXFORD) LTD
|
BY:
/s/ Anane S.F. Barros
NAME: Anane S.F. Barros
ID: 38.24S.912-x
|
BY:
/s/ Stephanie Bewick
NAME: STEPHANIE BEWICK
ID: VP, BUSINESS DEVELOPMENT
20
th
December 2017
|
REF
|
MNEMONIC
|
STATUS
|
FAMILY
|
LOC
|
AGENT REF
|
APPLICATION NUMBER
|
PUBLICATION NUMBER/
PATENT NUMBER
|
PRIORITY
DATE
|
FILING DATE
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
Dated 23 December 2017
|
D WILLIAMS & OTHERS (1)
SUMMIT THERAPEUTICS PLC (2)
|
SHARE PURCHASE AGREEMENT
relating to
DISCUVA LIMITED
|
|
Salisbury House
29 Finsbury Circus
London EC2M 5PS
Tel: 020 7638 9271
Fax: 020 7628 7525
Ref: DXS/SUM16.13
|
1.
|
Interpretation
|
3
|
2.
|
Sale and purchase
|
14
|
3.
|
Purchase Price
|
14
|
4.
|
Consideration Shares
|
17
|
5.
|
Purchase Price Adjustment and Completion Accounts
|
20
|
6.
|
Completion
|
21
|
7.
|
Warranties
|
22
|
8.
|
Limitations on claims
|
27
|
9.
|
The Buyer’s Warranties
|
32
|
10.
|
Tax Covenant
|
34
|
11.
|
Restrictions on the Sellers
|
34
|
12.
|
Confidentiality and announcements
|
37
|
13.
|
Further assurance
|
40
|
14.
|
Assignment
|
41
|
15.
|
No agency
|
42
|
16.
|
Entire agreement
|
42
|
17.
|
Variation and waiver
|
42
|
18.
|
Sellers’ Representatives
|
43
|
19.
|
Costs
|
45
|
20.
|
Notices
|
45
|
21.
|
Joint obligations
|
47
|
22.
|
Interest
|
48
|
23.
|
Severance
|
48
|
24.
|
Agreement survives Completion
|
48
|
25.
|
Third party rights
|
48
|
26.
|
Counterparts
|
49
|
27.
|
Rights and remedies
|
49
|
28.
|
Inadequacy of damages
|
49
|
29.
|
Governing law and jurisdiction
|
49
|
Schedule 1
|
52
|
|
|
|
Particulars of Sellers
|
52
|
|
|
Particulars of the Sellers and apportionment of Purchase Price
|
52
|
|
Schedule 2 - Particulars of the Company
|
56
|
|
|
Schedule 3 - Sellers' obligations at Completion
|
57
|
|
|
Schedule 4
- COMPLETION ACCOUNTS
|
60
|
|
|
Schedule 5 - DEFERRED CONSIDERATION
|
61
|
|
|
Schedule 6 - Warranties
|
65
|
|
|
|
Part 1 - General Warranties
|
65
|
|
|
Part 2 - Tax Warranties - Subject to review
|
103
|
|
Schedule 7 - Tax Covenant
|
121
|
|
|
Schedule 8 - Intellectual Property Rights
|
138
|
|
|
|
Part 1 - Registered Intellectual Property Rights
|
138
|
|
|
Part 2 - Material unregistered Intellectual Property Rights
|
138
|
|
|
Part 3 - Intellectual Property Rights licensed from third parties
|
138
|
|
Schedule 9
|
139
|
|
|
Part 4 - Intellectual Property Rights licensed to third parties
|
139
|
|
|
Schedule 10 - THE RETENTION
|
140
|
|
|
Schedule 11 - Information technology
|
142
|
|
|
|
Part 1 - Particulars of IT System
|
142
|
|
|
Part 2 - Particulars of IT Contracts
|
142
|
|
Schedule 12 - The PropertY
|
143
|
|
|
|
Part 1 - Particulars of the Leasehold Property
|
143
|
|
Schedule 13
|
144
|
|
|
THE TRANSFER INCENTIVES
|
144
|
|
(1)
|
The several persons whose names and addresses are set out in Schedule 1 (Sellers).
|
(2)
|
SUMMIT THERAPEUTICS PLC
incorporated and registered in England and Wales with company number
05197494
whose registered office is at
136a Eastern Avenue, Milton Park, Abingdon, Oxfordshire, United Kingdom, OX14 4SB
(Buyer).
|
(A)
|
The Company is a private company limited by shares incorporated in England and Wales.
|
(B)
|
The Company has an issued share capital of £55,531.137 divided into 22,649,006 ordinary shares of £0.001 each, 3,288,213 preference shares of £0.01 each and one Z ordinary share of £0.001.
|
(C)
|
Further particulars of the Company at the date of this agreement are set out in Schedule 2.
|
(D)
|
The Sellers are the owners of the legal and beneficial title to the number of Sale Shares set out opposite their respective names in Schedule 1.
|
(E)
|
The Sellers have agreed to sell and the Buyer has agreed to buy the Sale Shares subject to the terms and conditions of this agreement.
|
1.
|
Interpretation
|
1.1
|
The definitions and rules of interpretation in this clause apply in this agreement.
|
Accounts
|
the full form shareholder unaudited accounts of the Company (prepared under section 394 of the CA 2006) for the accounting period ended on the Accounts Date, including the statement of financial position as at the Accounts Date, the income statement for the twelve months ending on the Accounts Date and the related notes to the accounts as required by law and applicable accounting standards, copies of which are included in the Disclosure Bundle.
|
Accounts Date
|
March 31, 2017
|
Adjustment Date
|
the fifth Business Day following the date on which the Purchase Price Statement is agreed or determined (as the case may be) in accordance with Schedule 4.
|
AIM
|
means AIM, a market operated by the LSE
|
AIM Rules
|
the AIM Rules for Companies published by the LSE and setting out the rules and responsibilities in relation to companies with a class of securities admitted to AIM.
|
Bactevo
|
Bactevo Limited, a company incorporated in England and Wales with registered number 8328823.
|
Bactevo Agreements
|
the following agreements between the Company and Bactevo, namely:
(a)
IP Amendment and Assignment dated 17 December 2014 between the Company and Bactevo; and
(b)
IP Assignment and Licence dated 22 March 2013 between the Company and Bactevo.
|
Bactevo Amendment Agreement
|
an agreement in the agreed form to amend the Bactevo Agreements be entered into between the Company and Bactevo at or prior to Completion.
|
Business
|
the business carried on by the Company at Completion, namely the use of antibiotic deconvolution technology to identify chemical mechanisms of action and resistance in order to select and optimise the creation of drug candidates, or any part of it.
|
Business Day
|
a day other than a Saturday, Sunday or public holiday in England when banks in London are open for business.
|
Buyer's Solicitors
|
Druces LLP of Salisbury House, London Wall, London EC2M 5PS.
|
CA 2006
|
the Companies Act 2006.
|
CAA 2001
|
the Capital Allowances Act 2001.
|
Cash
|
has the meaning set out in Paragraph 1.1 of Schedule 4
|
Cash Consideration
|
has the meaning set out in clause 3.1.1.
|
Cash Price
|
the sum of £5,000,000 (Five Million Pounds) payable by the Buyer to the Sellers on Completion as part of the Purchase Price.
|
Consideration Shares
|
the ordinary shares of £0.01 each in the capital of the Buyer and having the rights and composition set out at clause 4.1 to be allotted and issued to the Sellers in accordance with clause 3.1 in part consideration of the Purchase Price payable to the Sellers by the Buyer in respect of the sale of the Sale Shares.
|
CMA
|
the Competition and Markets Authority.
|
Company
|
Discuva Limited, a company incorporated and registered in England and Wales with company number 06169490 whose registered office is at The Merrifield Centre, Rosemary Lane, Cambridge CB1 3LQ, further details of which are set out in Schedule 1.
|
Completion
|
completion of the sale and purchase of the Sale Shares in accordance with this agreement.
|
Completion Date
|
means the date of this agreement.
|
Completion Payment
|
the sum of £5,000,000:
(a)
plus an amount equal to the Estimated Cash;
(b)
less an amount equal to the Estimated Indebtedness.
|
Connected
|
has, in relation to a person, the meaning given in section 1122 of the CTA 2010.
|
Control
|
has the meaning given in section 1124 of the CTA 2010, and the expression change of Control shall be construed accordingly.
|
CTA 2009
|
the Corporation Tax Act 2009.
|
CTA 2010
|
the Corporation Tax Act 2010.
|
Deal Fees
|
the costs, fees, disbursements and VAT of:
(a)
the Sellers’ Solicitors for advising on the negotiation and completion of this agreement (being £[**] plus VAT);
(b)
Price Bailey LLP for advising the Sellers on the tax elements of this agreement (being £[**] plus VAT).
|
Deferred Consideration
|
the contingent deferred consideration forming part of the Purchase Price, determined and payable in accordance with Schedule 5.
|
Director
|
each person who is a director or shadow director of the Company, as set out in Schedule 2.
|
Disclosed
|
fairly disclosed (with sufficient details to identify the nature and scope of the matter disclosed) in or under the Disclosure Letter.
|
Disclosure Bundle
|
the bundle of documents, in agreed form, annexed to the Disclosure Letter.
|
Disclosure Letter
|
the letter, in agreed form, from the Sellers to the Buyer with the same date as this agreement and described as the Disclosure Letter, together with the Disclosure Bundle.
|
DPA 1998
|
the Data Protection Act 1998.
|
Effective Time
|
has the meaning set out in Paragraph 1.1 of Schedule 4.
|
Employee
|
has the meaning given in paragraph Schedule 6 Part 1 -27.1 of Schedule 6.
|
Encumbrance
|
any interest or equity of any person (including any right to acquire, option or right of pre-emption) or any mortgage, charge, pledge, lien, assignment, hypothecation, security interest, title retention or any other security agreement or arrangement.
|
Estimated Cash
|
the Sellers’ estimate of the Cash, as set out in the Estimates Statement
|
Estimated Indebtedness
|
the Sellers’ estimate of the Indebtedness, as set out in the Estimates Statement.
|
Estimates Statement
|
the statements provided by the Sellers to the Buyer on the Business Day prior to Completion setting out their good faith estimates of the current Cash, Indebtedness and the resulting calculation of the Completion Payment accompanied by reasonable supporting documents.
|
FCA
|
the Financial Conduct Authority.
|
FSMA
|
the Financial Services and Markets Act 2000.
|
FRS 102
|
Financial Reporting Standard 102: The Financial Reporting Standard applicable in the UK and Republic of Ireland as issued by the Financial Reporting Council of the UK and in force for the accounting period ended on the Accounts Date.
|
Fundamental Warranties
|
the Warranties set out in paragraphs Schedule 6 Part 1 -1.1, Schedule 6 Part 1 -1.2, Schedule 6 Part 1 -2.2 or Schedule 6 Part 1 -2.3.
|
Fundamental Warranty Claim
|
a claim for breach of the Fundamental Warranties.
|
Group
|
in relation to a company, that company, any subsidiary undertaking or any parent undertaking from time to time of that company, and any subsidiary undertaking from time to time of a parent undertaking of that company. Each company in a Group is a
member of the Group
.
|
HMRC
|
HM Revenue & Customs.
|
holding company
|
has the meaning given in clause 1.11.
|
ICTA 1988
|
the Income and Corporation Taxes Act 1988.
|
IHTA 1984
|
the Inheritance Tax Act 1984.
|
Ian George
|
a holder of Sale Shares whose details are set out in Schedule 1.
|
Individual Dispute
|
means in relation to any Seller a Fundamental Warranty Claim, or any other matter in relation to which such Seller is individually responsible pursuant to this agreement.
|
Indebtedness
|
has the meaning set out in Paragraph 1.1 of Schedule 4.
|
Insurance Premium Contribution
|
the sum of £[**] payable by the Sellers at Completion as their aggregate contribution towards the premium payable in respect of the Policy (being equal to [**]% of the premium for the Policy).
|
Insured Risks
|
the Risks as defined in the Policy.
|
Insurers
|
The definition used in the Policy.
|
Policy
|
the insurance policy taken out shortly before Completion to which the Company and certain of the Sellers are Insured Persons (as defined in such policy).
|
Preferred Shares
|
the 3,288,213 preference shares of £0.01 each of the Company, all of which are issued fully paid, and in respect of which £649,548.80 of dividends are in arrears (the
Dividend Arrears
).
|
Previous Accounts
|
the accounts equivalent to the Accounts in respect of each of the two accounting periods immediately preceding the accounting period ended on the Accounts Date.
|
Previously-owned Land and Buildings
|
has the meaning given in Schedule 6 Part 1 -29.1.
|
PropCo
|
Merrifield Centre Ltd, a company incorporated in England and Wales with registered number 11118349.
|
PropCo Sellers
|
those Sellers who are also shareholders in PropCo.
|
Property
|
has the meaning given in Schedule 6 Part 1 -29.1
|
Purchase Price
|
the aggregate purchase price for the Sale Shares, as set out in, and to be paid or satisfied in accordance with Clause 3.1.
|
Purchase Price Statement
|
has the meaning set out in Paragraph 1.1 of Schedule 4.
|
R & D Payments
|
contingent payments by way of further additions to the Purchase Price to be made pursuant to clause 3.5.
|
R & D Tax Credits
|
the amount of any payment made by HMRC and received and retained by the Company as the result of the Company surrendering any amount of allowance or credit for Tax in respect of expenditure on research & development for any accounting period of the Company.
|
Relevant Claim
|
a Warranty Claim, a Fundamental Warranty Claim, a Tax Protection Claim or any other claim under this agreement (save for a claim made pursuant to 11 (Seller Restrictions)).
|
Respective Proportion
|
in relation to any Seller, the proportion of any sum or liability as is equal to the
proportion which his Sale Shares bear to the Sale Shares as a whole, as set out in the final column of the table in Schedule 1.
|
Retention
|
the sum of £[**] to be withheld from the Completion Payment and dealt with in accordance with Schedule 10.
|
Retention Account
|
has the meaning set out in paragraph 1 of Schedule 10.
|
Roche
|
F. Hoffman – La Roche Limited, a Swiss corporation located at Grenzacherstrasse 124, 4070 Basel, Switzerland.
|
Roche JV Agreement
|
the following agreements between the Company and Roche, namely:
a) Research Collaboration, Option and License Agreement dated 21 February 2014 between the Company and Roche and F. Hoffman-La Roche Inc;
b) Amendment No 1 dated 12 June 2015 to the Research Collaboration, Option and License Agreement dated 21 February 2014 between the Company and Roche and F. Hoffman-La Roche Inc; and
c) Amendment No 2 dated 21 February 2017 to the Research Collaboration, Option and License Agreement dated 21 February 2014 between the Company and Roche and F. Hoffman-La Roche Inc.
|
Sale Shares
|
the 22,684,006 ordinary shares of £0.001 each in the Company, 3,288,213 preference shares of £0.01 each in the Company and one Z ordinary share of £0.001 in the Company, all of which are issued and fully paid, and which comprise the whole of the issued share capital of the Company.
|
Seller Majority
|
Sellers who together held not less than 75% of the Sale Shares by nominal value immediately prior to Completion
|
Sellers’ Representatives
|
David Williams, Giorgio Reggiani and New Wave, or such other persons as may be elected in writing by a Seller Majority from time to time.
|
Sellers' Solicitors
|
Taylor Vinters LLP of Merlin Place, Milton Road, Cambridge CB4 0DP.
|
Substantiated Claim
|
means any Relevant Claim (to the extent not withdrawn by the Buyer in writing) which has been agreed in writing between the Buyer and the Sellers’ Representatives or formally determined by an English Court of competent jurisdiction and, in relation to which, all rights of appeal have been exhausted or are debarred by passage of time.
|
subsidiary
|
has the meaning given in clause 1.11.
|
subsidiary undertaking
|
a subsidiary undertaking as defined in section 1162 of the CA 2006.
|
Tax
|
has the meaning given in paragraph 1.1 of Schedule 7.
|
Tax Authority
|
has the meaning given in paragraph 1.1 of Schedule 7.
|
Tax Protection Claim
|
a claim pursuant to the Tax Covenant or the Tax Warranties.
|
Tax Covenant
|
the tax covenant set out in Schedule 7.
|
Tax Statute
|
has the meaning given in paragraph 1.1 of Schedule 7.
|
Tax Warranties
|
the Warranties in respect of tax set out in Part 2 of Schedule 6.
|
TCGA 1992
|
the Taxation of Chargeable Gains Act 1992.
|
TIOPA 2010
|
the Taxation (International and Other Provisions) Act 2010.
|
TMA 1970
|
the Taxes Management Act 1970.
|
Transaction
|
the transaction contemplated by this agreement or any part of that transaction.
|
Transaction Documents
|
this agreement, the Disclosure Letter, the Bactevo Amendment Agreement, the New Lease, the Transitional Services Agreement and the documents listed in paragraphs 1.1.14 and 1.1.15 of Part 1 of Schedule 3 and any other document to be entered into pursuant to this agreement in connection with the Transaction.
|
Transfer Incentives
|
certain contingent obligations of the Company to certain of its employees and consultants, payable on the happening of certain events, in the maximum amounts referred to in Schedule 13 the terms of which are more particularly set out in the bonus plan document to be executed at or prior to Completion (a copy of which is included in the Disclosure Bundle).
|
Transitional Services Agreement
|
the agreement between the Company and Bactevo to be entered into at or prior to Completion in the agreed form.
|
VATA 1994
|
the Value Added Tax Act 1994.
|
Warranties
|
the warranties and representations given by the Sellers pursuant to clause 7 and set out in Schedule 6.
|
Warranty Claim
|
a claim for breach of the Warranties (excluding the Fundamental Warranties).
|
Z Ordinary Share
|
the Z ordinary share of £0.001 of the Company which is issued and fully paid.
|
|
|
1.2
|
Clause, Schedule and paragraph headings shall not affect the interpretation of this agreement.
|
1.3
|
References to clauses and Schedules are to the clauses of and Schedules to this agreement and references to paragraphs are to paragraphs of the relevant Schedule.
|
1.4
|
The Schedules form part of this agreement and shall have effect as if set out in full in the body of this agreement. Any reference to this agreement includes the Schedules.
|
1.5
|
A reference to this agreement or any other agreement or document referred to in this agreement, is a reference to this agreement or such other agreement or document as varied or novated (in each case, other than in breach of the provisions of this agreement) from time to time.
|
1.6
|
Unless the context otherwise requires, words in the singular shall include the plural and the plural shall include the singular.
|
1.7
|
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders.
|
1.8
|
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality).
|
1.9
|
This agreement shall be binding on and enure to the benefit of, the parties to this agreement and their respective personal representatives, successors and permitted assigns, and references to a party shall include that party's personal representatives, successors and permitted assigns.
|
1.10
|
A reference to a company shall include any company, corporation or other body corporate, wherever and however incorporated or established.
|
1.11
|
A reference to a holding company or a subsidiary means a holding company or a subsidiary (as the case may be) as defined in section 1159 of the CA 2006 and for the purposes only of the membership requirement contained in sections 1159(1)(b) and (c), a company shall be treated as a member of another company even if its shares in that other company are registered in the name of:
|
1.11.1
|
another person (or its nominee), by way of security or in connection with the taking of security; or
|
1.11.2
|
its nominee.
|
1.12
|
A reference to the Sellers shall include a reference to each of them.
|
1.13
|
Unless otherwise expressly provided in this agreement, a reference to
writing
or
written
does not include fax and email.
|
1.14
|
Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.
|
1.15
|
References to a document in agreed form are to that document in the form agreed by the parties and initialled by the Sellers’ Solicitors and the Buyer’s Solicitors for identification.
|
1.16
|
Unless otherwise provided, a reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time provided that, as between the parties, no such amendment, extension or re-enactment made after the date of this agreement shall apply for the purposes of this agreement to the extent that it would impose any new or extended obligation, liability or restriction on, or otherwise adversely affect the rights of, any party.
|
1.17
|
A reference to a statute or statutory provision shall include all subordinate legislation made from time to time under that statute or statutory provision.
|
1.18
|
Any reference to an English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than England, be deemed to include a reference to that which most nearly approximates to the English legal term in that jurisdiction.
|
1.19
|
Any obligation on a party not to do something includes an obligation not to allow that thing to be done.
|
1.20
|
In assessing damages for any Substantiated Claims in respect of a Relevant Claim, no Seller shall be liable to the Buyer for any special, indirect or consequential loss including (without
|
2.
|
Sale and purchase
|
2.1
|
On the terms of this agreement and subject to the Conditions, at Completion the Sellers shall sell and the Buyer shall buy, with effect from Completion, the Sale Shares with full title guarantee and free from all Encumbrances, together with all rights that attach (or may in the future attach) to the Sale Shares including, in particular, the right to receive all dividends and distributions declared, made or paid on or after the date of this agreement (and, in the case of the Preference Shares, all rights to receive accumulated but unpaid dividends).
|
2.2
|
Each Seller waives any rights of pre-emption or other restrictions on transfer in respect of the Sale Shares (or any of them) conferred by the Company's articles of association or otherwise (including, for the avoidance of doubt, the transfer of shares by New Wave pursuant to article 9.1 of the articles of association of the Company).
|
2.3
|
New Wave consents to its Preference Shares being dealt with as set out in clause 3.1 as opposed to being redeemed pursuant to article 3.1 of the articles of association of the Company.
|
2.4
|
The Buyer is not obliged to complete the purchase of any of the Sale Shares unless the purchase of all the Sale Shares is completed simultaneously.
|
2.5
|
Those of the Sellers that are party to a subscription and shareholders agreement relating to the Company dated 2 December 2011 as amended by a deed of amendment and dated 20 December 2012 hereby agree to its termination as at and with effect from Completion.
|
3.
|
Purchase Price
|
3.1
|
The Purchase Price is £10,000,000 as adjusted in accordance with clause 5, plus the Deferred Consideration, which shall be satisfied by the Buyer:
|
3.1.1
|
paying £5,000,000 in cash on Completion, such payment to be made in accordance with clause 3.4
(
Cash Consideration
) less the Retention to be dealt with in accordance with clause 6.2.2 and Schedule 10;
|
3.1.2
|
allotting and issuing on Completion to the Sellers credited as fully paid, the number of Consideration Shares having an aggregate value (as determined in accordance with clause 4.2)
which is as close as possible to £5,000,000
without issuing fractions of a Consideration Share in the numbers set out against their respective names in column 7 of Schedule 1;
|
3.1.3
|
paying the Deferred Consideration in the amounts and on the dates determined in accordance with Schedule 5; and
|
3.1.4
|
any further sums that may become payable to the Sellers pursuant to clause 3.6.
|
3.2
|
Each Optionholder hereby agrees to the amounts listed against that Optionholders names in columns 8 and 9 of the table in Schedule 1 representing (i) the aggregate exercise monies and (ii) any Tax which arises in respect of his or her Option and which the Company must account to HMRC, shall be deducted from that Optionholders entitlement to the proportion of the Cash Consideration payable to them in accordance with the terms of this agreement. The Buyer and each of the Optionholders each agree that the amount listed against that Optionholders name in columns 8 and 9 of the table in Schedule 1 will be paid by the Buyer to the Company on behalf of the Optionholder at Completion and the Company will account to HMRC in respect of the amount representing Tax in satisfaction of any Tax due, and the Buyer shall procure that the Company shall account promptly to HMRC for all Tax, PAYE and NICs on the Options.
|
3.3
|
To the extent that the Cash Consideration payable to an Optionholder at Completion is insufficient to cover the obligations set out in clause 3.2 above each such Optionholder shall put the Company in funds for any shortfall at Completion, and where such individual has provided a sum to the Company which is in excess of this actual liability to pay the Company shall return (and the Buyer shall procure that the Company shall so return) the excess to the relevant Optionholder within 15 Business Days following Completion.
|
3.4
|
All payments to be made to the Sellers under this agreement shall be made in sterling by electronic transfer of immediately available funds to the Sellers’ Solicitors (who are irrevocably authorised by the Sellers to receive the same). Payment in accordance with this clause shall be a good and valid discharge of the Buyer’s obligation to pay the sum in question and the Buyer shall not be concerned to see the application of the monies so paid.
|
3.5
|
The Purchase Price shall be deemed to be reduced by the amount of any payment made to the Buyer for each and any Relevant Claim.
|
3.6
|
The Purchase Price shall be increased by the following sums which shall be paid in accordance with clause 3.3 as follows:
|
3.6.1
|
In the event, and to the extent that the Company receives a cash payment from HMRC by way of an R&D Tax Credit in respect of its financial year which ended on 31 March 2016, the Buyer shall pay a further cash amount to the Sellers by way of consideration for the purchase of the Sale Shares as an increase in the Purchase Price equal to [**]% (after the deduction of the costs of recovery) of the R&D Tax Credit so received by the Company.
|
3.6.2
|
In the event, and to the extent that, the Company receives a cash payment from HMRC by way of an R & D Tax Credit in respect of its financial year which ended on 31 March 2017, the Buyer shall pay a further cash amount to the Sellers by way of consideration for the purchase of the Sale Shares as an increase in the Purchase Price, as follows:
|
3.6.2.1
|
if the payment is less than or equal to £[**], an amount equal to the payment; or
|
3.6.2.2
|
if the payment is greater than £[**], an amount equal to £[**] plus [**]; or
|
3.6.2.3
|
if the payment is greater than £[**], an amount equal to the excess over £[**], plus £[**].
|
3.6.3
|
(Save where clause 3.6.4 applies) In the event, and to the extent that, the Company receives a cash payment from HMRC by way of an R & D Tax Credit in respect of the period commencing on 1 April 2017 and ending on the Completion Date, the Buyer shall pay to the Sellers a further cash amount as an increase in the Purchase Price, by way of consideration for the Sale Shares, equal to the R & D Tax Credit so received by the Company (which shall be determined on a
pro rata temporis
basis on the assumption that such credit is earned on a straight line basis across the accounting period of the Company in which Completion falls).
|
3.6.4
|
Any payment to be made pursuant to clause 3.6.2 or 3.6.3 above shall be made within [**] Business Days of the actual receipt into the Company’s bank account of the R & D Tax Credit by reference to which such payment is calculated.
|
3.6.5
|
In the event, and to the extent that the Company receives a corporation tax credit as a result of the exercise of the Options, the Buyer shall pay a further cash amount to the Sellers by way of consideration for the purchase of the Sale Shares as an increase in the Purchase Price equal to the amount of that corporation tax credit so received by the Company.
|
4.
|
Consideration Shares
|
4.1
|
The Consideration Shares shall rank pari passu in all respects with the existing ordinary shares of £0.01 each in the capital of the Buyer, including the right to receive all dividends declared, made or paid after the Completion Date (save that they shall not rank for any dividend or other distribution of the Buyer declared made, or paid by reference to a record date before the Completion Date).
|
4.2
|
For the purposes of clause 3.1.2, the value of each Consideration Share shall be 170.4p
|
4.3
|
Each Seller undertakes to the Buyer that he shall not, during the nine months following Completion (the
Lock-in Period
), sell, transfer or otherwise dispose of, or create any Encumbrance over, any of the Consideration Shares (or any interest in them) held by the relevant Seller, or enter into any agreement to do so, except in accordance with
clause 4.6
.
|
4.4
|
Each Seller undertakes to the Buyer that for a period of twelve months following the end of the Lock-in Period (the
Orderly Market Period
) he shall not sell, transfer or otherwise dispose of any of the Consideration Shares (or any interest in them) held by the relevant Seller or enter into any agreement to do so unless:
|
(a)
|
he does so in accordance with clause 4.5 or clause 4.6; or
|
(b)
|
any such sale, transfer or other disposal takes place through brokers nominated by the Buyer provided that such brokers are able to offer terms as to price, commission and order size which are reasonably in line with such terms offered by other brokers (and for the avoidance of doubt, if such brokers are unable to complete any such sale, transfer or other disposal on such terms within 20 Business Days of it having received the written request to do so by or on behalf of a Seller, that Seller shall be entitled to effect such sale, transfer or other disposal through such broker as he shall decide).
|
4.5
|
Each Seller shall be entitled to sell, transfer or otherwise dispose of the Consideration Shares pursuant to Clause 4.4 only under the following conditions:
|
4.6
|
Nothing in clause 4.3, 4.4 or 4.5 shall prevent a Seller from selling, transferring or otherwise disposing of any Consideration Shares (or any interest in them):
|
4.6.1
|
in acceptance of a general offer made in accordance with the City Code on Takeovers and Mergers by any third party for the whole of the ordinary share capital of the Buyer (other than any ordinary share capital owned by the offeror or any concert party of the offeror);
|
4.6.2
|
pursuant to an irrevocable commitment to accept any offer made in accordance with the City Code on Takeovers and Mergers for the whole of the ordinary share capital of the Buyer (other than any ordinary share capital owned by the offeror or any concert party of the offeror);
|
4.6.3
|
where such disposal is made pursuant to an offer by the Buyer to purchase its own shares which is made on identical terms to all holders of ordinary shares in the Buyer and otherwise complies with the CA 2006 and the AIM Rules;
|
4.6.4
|
pursuant to any scheme of reconstruction under section 110 of the Insolvency Act 1986 in relation to the Buyer;
|
4.6.5
|
pursuant to any compromise or arrangement under Part 26 of the CA 2006 which is agreed by the requisite majority of the members of the Buyer and sanctioned by the court;
|
4.6.6
|
with the prior written consent of the Buyer; or
|
4.6.7
|
where the sale, transfer or other disposal is made (whether inter vivos or by testamentary disposition or on intestacy) to:
|
4.6.7.1
|
a member of the Seller’s family; or
|
4.6.7.2
|
trustees of any trust, the principal beneficiaries of which are primarily the Seller and/or members of his family,
|
4.6.7.3
|
any person within the meaning of paragraphs c(iii) to (v) of the definition of "related party" in the AIM Rules as if that Seller fell within paragraphs (a) and/or (b) of such definition,
|
4.6.8
|
where the sale, transfer or other disposal is made to the extent that the sale proceeds (net of incidental costs) are required by the relevant Seller to meet and are wholly applied in meeting, any liability of the Sellers arising under any Relevant Claim.
|
4.7
|
For the avoidance of doubt no commission shall be payable to the Company's nominated broker in respect of any transfer of Consideration Shares transferred in any of the circumstances set out in clause 4.6 (other than clause 4.6.8) where the Seller is obliged (whether by this agreement or otherwise) by the Buyer to dispose of such Consideration Shares via the nominated broker.
|
4.8
|
For the purposes of clause 4.3 and 4.4 the Consideration Shares shall include:
|
4.8.1
|
any shares held by each Seller arising out of the consolidation, conversion or subdivision of any of the Consideration Shares; and
|
4.8.2
|
any shares acquired by reference to the Consideration Shares, whether by way of a bonus or rights issue, pre-emption right or otherwise, or in exchange or substitution for any of the Consideration Shares.
|
4.9
|
The Buyer shall use its best endeavours to procure admission of the Consideration Shares to AIM becoming effective in accordance with the AIM Rules (the
Listing Condition
).
|
4.10
|
If the Listing Condition shall not have been satisfied within 15 Business Days of Completion, the Buyer shall pay the Sellers £5,000,000 in cash in accordance with clause 3.3 and such cash shall be distributed to the Sellers in proportion to the number of Consideration Shares that would have been issued to the Sellers and from the time of payment of such cash the Sellers shall hold the Consideration Shares to the order of the Buyer and shall (at the Buyer’s cost) act in accordance with any lawful instructions given by the Buyer to transfer, cancel or otherwise dispose of the Consideration Shares in such manner as the Buyer shall direct. In the case that cash shall be paid instead of Consideration Shares, all provisions relating to the Consideration Shares shall apply to the cash in so far as possible (save in respect of any provisions of clause 4.3 and 4.4).
|
5.
|
Purchase Price Adjustment
|
5.1
|
The Completion Payment shall be adjusted as at Completion by
|
5.1.1
|
adding an amount equal to the Estimated Cash; and
|
5.1.2
|
subtracting an amount equal to the Estimated Indebtedness.
|
5.2
|
The Buyer shall pay the Completion Payment to the Sellers in cash on Completion on account of the Purchase Price, less the Retention.
|
5.3
|
The parties shall procure that the Purchase Price Statement (adjusted pursuant to clause 5.1 above) is prepared and agreed or determined (as the case may be) in accordance with Schedule 4.
|
5.4
|
The following payments shall be made on or before the Adjustment Date:
|
5.4.1
|
if the amount of the Purchase Price as set out in the Purchase Price Statement exceeds the Completion Payment, the Buyer shall (subject to Clause 5.6) pay to the Sellers an amount equal to the excess; or
|
5.4.2
|
if the amount of the Purchase Price as set out in the Purchase Price Statement is less than the Completion Payment, the Sellers shall pay to the Buyer an amount equal to the shortfall.
|
5.5
|
Any payment due to the Buyer under clause
5.4 shall first be met out of the Retention in accordance with Schedule 10. To the extent that the Retention is insufficient, any further payment shall be made by electronic transfer to such account of the Buyer or the Buyer’s Solicitors as is notified to the Sellers by or on behalf of the Buyer no later than 2 Business Days before the Adjustment Date and such payment shall be made by the Sellers in their Respective Proportions.
|
5.6
|
If, at the Adjustment Date,
any amount is due for payment by the Sellers to the Buyer in respect of a Substantiated Claim the Buyer shall be entitled (at its sole discretion) to satisfy all (to the extent possible) or part of the Sellers’ outstanding payment obligation by way of set-off against any amount that is payable by the Buyer under
c
lause 5.4.1
, and to treat its obligation to pay that sum as being reduced pro tanto by the amount so set off.
|
6.
|
Completion
|
6.1
|
Completion shall take place on the Completion Date at the offices of the Buyer's Solicitors or at such other place as is agreed by the parties in writing.
|
6.2
|
At Completion:
|
6.2.1
|
the Sellers shall:
|
6.2.1.1
|
deliver or cause to be delivered to the Buyer the items listed in Schedule 3;
|
6.2.1.2
|
procure that a board meeting of the Company is held at which the matters set out in paragraph 2 Schedule 3 are carried out; and
|
6.2.1.3
|
deliver any other documents referred to in this agreement as being required to be delivered by the Sellers at Completion; and
|
6.2.1.4
|
pay the Insurance Premium Contribution to the Company;
|
6.2.2
|
the Buyer shall (subject to the Sellers complying with their obligations in clause 6.2.1):
|
6.2.2.1
|
pay the Completion Payment in accordance with clause 3.1 and clause 5.1 (less the Retention);
|
6.2.2.2
|
pay the Retention into the Retention Account;
|
6.2.2.3
|
deliver to the Sellers a certified copy of the resolution, in agreed form, adopted by the Buyer's board of directors approving Completion and the execution and delivery of any Transaction Documents to be delivered by the Buyer at Completion and the allotment and issue of the Consideration Shares to the Sellers;
|
6.2.2.4
|
procure that each of the Sellers shall be entered into the Buyer’s register of members (shareholders) as a holder of the relevant number of Consideration Shares and deliver evidence of such
|
6.2.2.5
|
allot and issue the Consideration Shares to the Sellers in accordance with clause 3.1.2; and
|
6.2.2.6
|
promptly deliver to the Company’s nominated adviser (with a copy to the Sellers’ Representatives) a duly signed application to admit the Consideration Shares to AIM.
|
6.3
|
As soon as possible after Completion, the Sellers shall send to the Buyer all records, correspondence, documents, files, memoranda and other papers relating to the Company which are not kept at the Property and which are not required to be delivered at Completion.
|
6.4
|
The Buyer shall procure that the Company shall pay the premium due on the Policy within [**] Business Days of Completion.
|
7.
|
Warranties
|
7.1
|
Each of the Sellers severally warrants to the Buyer that except as Disclosed as at Completion each of the Fundamental Warranties is accurate, true and not misleading in relation to themselves
|
7.2
|
Each of the Non-New Wave Sellers severally warrant to the Buyer that except as Disclosed as at Completion each Warranty (except the Fundamental Warranties) is true, accurate and not misleading.
|
7.3
|
Warranties qualified by the expression ''so far as the Sellers are aware'' or any similar expression qualifying the knowledge of a Seller are deemed to be given to the best of the knowledge, information and belief of each of the Sellers after they have made due and careful enquiries of David Williams, Giorgio Reggiani and John Wain.
|
7.4
|
Each of the Warranties is separate and, unless otherwise specifically provided, is not limited by reference to any other Warranty or any other provision in this agreement.
|
7.5
|
The only Warranties in connection with the Properties are those contained in the following paragraphs of Part 1 of Schedule 6:
|
7.5.1
|
Schedule 6 Part 1 -29 (Properties); and
|
7.5.2
|
Schedule 6 Part 1 -30 (Environmental).
|
7.6
|
Except for the matters Disclosed, no information of which the Buyer (or any of its agents or advisers) has knowledge (in each case whether actual, constructive or imputed), or which could have been discovered (whether by investigation made by the Buyer or on its behalf), shall prejudice or prevent any Relevant Claim or reduce the amount recoverable under any Relevant Claim. Notwithstanding the forgoing provisions of this Clause the Buyer confirms that it is not aware of any matters that entitle it (or would entitle it) to bring a Relevant Claim.
|
7.7
|
The Sellers agree that the supply of any information by or on behalf of the Company, or any of its employees, directors, agents or officers (Officers) to the Sellers or their advisers in connection with the Warranties, the Disclosure Letter or otherwise shall not constitute a warranty, representation or guarantee as to the accuracy of such information in favour of the Sellers.
|
7.8
|
For the avoidance of doubt, the Buyer's rights and remedies in respect of any Relevant Claim shall not be affected by Completion, or any termination of (or the Buyer's failure to terminate) this agreement.
|
7.9
|
The Buyer warrants to the Sellers that the execution and delivery of this agreement and the transactions contemplated herein (including, but not limited to, the issue of the Consideration Shares) have, where required, been duly and validly authorised and no other proceedings or actions are necessary to authorise this agreement or to complete the transactions contemplated herein.
|
7.10
|
If and to the extent that a liability arises in respect of a Substantiated Claim which is not otherwise excluded pursuant to the provisions of clause 8 (a Claim Liability), the provisions of this clause shall operate to allocate the relevant Claim Liability amongst the Sellers, subject at all times to the Cap. Accordingly the Claim Liability shall:
|
7.10.1
|
first, fall to the account of the Non-New Wave Sellers, provided that (i) the maximum amount to which the Non-New Wave Sellers shall be obliged to contribute towards the Claim Liability shall be an amount equal to 50 per cent of the aggregate unadjusted Cash Consideration actually received by such Non-New Wave Sellers on the Completion Date (after the amounts payable to New Wave in respect of the purchase of the Preference Shares together with the interest accrued thereon have been settled from the aggregate unadjusted Cash Consideration and excluding any sum in respect of which a set-off or deduction is made from the Retention) (the First Call Cash) and (ii) provided always that the contribution amounts for each Non-New Wave Seller to the Claim Liability shall be strictly made in the proportions by which each Non-New Wave Seller's amount of First Call Cash bears to the aggregate amount of First Call Cash;
|
7.10.2
|
second, if and to the extent that the Claim Liability is not settled in full by the First Call Cash, then any such remaining residual Claim Liability shall fall to the account of the Non-New Wave Sellers, who shall be obliged to satisfy such remaining Claim Liability through contributing the proceeds realised (net of expenses) from the sale of Consideration Shares which were issued to them on or shortly after the Completion Date, provided that (i) in satisfying the Claim Liability, the maximum liability of the Non-New Wave Sellers shall be the proceeds (net of expenses) arising from the sale of 37.5 per cent of the aggregate number of Consideration Shares issued to them on or shortly after the Completion Date (the First Call Shares) and (ii) if at such time any or all of the First Call Shares have already been sold, any relevant Non-New Wave Seller shall, subject to (iii), be obliged to contribute such amount of the actual realised proceeds (net of expenses) from the sale of such First Call Shares towards satisfying its proportion of the Claim Liability and (iii) the contributions towards the Claim Liability by each Non-New Wave Seller shall be made strictly by reference to the proportion by which each Non-New Wave Seller's number of Consideration Shares bears to the aggregate number of Consideration Shares issued to the Non-New Wave Sellers;
|
7.10.3
|
third, if and to the extent that the Claim Liability is not settled in full by the First Call Cash together with the proceeds realised through the sale of First Call Shares, then any such remaining residual Claim Liability shall fall to the account of the New Wave Sellers, who agree to bear such liability notwithstanding that they may
|
7.10.4
|
fourth, if and to the extent that the Claim Liability is not settled in full by the First Call Cash together with the proceeds realised through the sale of First Call Shares and the Second Call Cash, then any such remaining residual Claim Liability shall fall to the account of the Non-New Wave Sellers, who shall be obliged to satisfy such remaining Claim Liability through contributing the proceeds realised (net of expenses) from the further sale of Consideration Shares which were issued to them on or shortly after the Completion Date, provided that (i) in satisfying the Claim Liability, the maximum liability of the Non-New Wave Sellers shall be the proceeds (net of expenses) arising from the sale of 37.5 per cent of the aggregate number of Consideration Shares issued to them on or shortly after the Completion Date (the Second Call Shares) and (ii) if at such time any or all of the Second Call Shares have already been sold, any relevant Non-New Wave Seller shall, subject to (iii), be obliged to contribute such amount of the actual realised proceeds (net of expenses) from the sale of such Second Call Shares towards satisfying its proportion of the Claim Liability and (iii) the contributions towards the Claim Liability by each Non-New Wave Seller shall be made strictly by reference to the proportion by which each Non-New Wave Seller's number of Consideration Shares bears to the aggregate number of Consideration Shares issued to the Non-New Wave Sellers;
|
7.10.5
|
fifth, if and to the extent that the Claim Liability is not settled in full by the First Call Cash, the Second Call Cash and the proceeds realised through the sale of First Call Shares and Second Call Shares, then any such remaining residual Claim Liability shall fall to the account of the New Wave Sellers, who agree to bear such liability notwithstanding that they may not have provided a warranty or covenant
|
7.10.6
|
thereafter, if and to the extent that the Claim Liability is not settled in full by the First Call Cash, the Second Call Cash and the proceeds realised through the sale of First Call Shares, Second Call Shares and Third Call Shares then any such remaining residual Claim Liability shall fall to the account of each of the Non-New Wave Sellers on the one hand and the New Wave Sellers, who agree to bear such liability notwithstanding that they may not have provided a warranty or covenant in relation to such matter, or personally been in breach thereof, on the other hand, in equal proportions between each such group, such residual Claim Liability to be satisfied by the entitlements of each group to receive actual payments from the Buyer of Deferred Consideration and each respective group's contribution to be satisfied (i) by way of the relevant Sellers contributing any Deferred Consideration payments actually received, and, if such amounts are insufficient, then (ii) by way of set-off or deduction once such Deferred Consideration becomes payable;
|
7.11
|
Notwithstanding the provisions of clause 7.10 the Buyer shall be entitled to bring proceedings in respect of any Relevant Claim against all Sellers simultaneously, provided that it may only recover in accordance with the order of priority set out in clause 7.10.
|
7.12
|
Notwithstanding the provisions of this clause 7, Schedule 6 or Schedule 7 the Sellers shall have no liability for any Insured Risk. To the extent that the Policy is avoided by the Insurers as a direct consequence only of:
|
7.12.1
|
any misrepresentation or failure to disclose to the Insurers any facts actually known to the Sellers or the Company at the time the Policy was granted; or
|
7.12.2
|
the occurrence of any of the events set out in clause 6.2 of the Policy,
|
8.
|
Limitations on claims
|
8.1
|
This clause 8 limits the liability of each of the Sellers in relation to any Relevant Claim.
|
8.2
|
The maximum aggregate liability of the Sellers in relation to all Relevant Claims (inclusive of all claims, costs, expenses, reasonably incurred legal and professional fees and disbursements, VAT, interest and penalties) shall not exceed the sum of [**] pounds sterling (£[**]) (the
Cap
) and each Seller's individual maximum aggregate liability in respect of any such Relevant Claims shall be limited in accordance with the provisions of clause 7.10.
|
8.3
|
A Seller shall not be liable:
|
8.3.1
|
in respect of a Relevant Claim (excluding a Tax Protection Claim) unless the amount of each such Substantiated Claim (together with any such connected Substantiated Claims) exceeds the sum of £[**] in which case in which case the liability of the relevant Sellers shall be for the total amount of such Substantiated Claims (and not limited to the amount above the threshold specified in this clause 8.3.1); and
|
8.3.2
|
in respect of a Relevant Claim unless the aggregate amount of all such Substantiated Claims either individually or when aggregated with all other Relevant Claims (other than those excluded under clause 8.3.1), exceeds the sum of £[**], in which case the liability of the relevant Sellers shall be for the total amount of such Substantiated Claims (and not limited to the amount above the threshold specified in this clause 8.3.2).
|
8.4
|
Each Seller shall not be liable in respect of a Relevant Claim unless notice in writing summarising the nature of the Relevant Claim (in so far as it is known to the Buyer) and, as far as is reasonably practicable, the amount claimed, has been given by or on behalf of the Buyer to each of the Sellers' Representatives as soon as practicable following the Buyer becoming aware that such circumstances entitles it to bring a Relevant Claim, but in any event:
|
8.4.1
|
in the case of a claim in respect of the Tax Warranties, on or before the date falling on the [**] anniversary of the Completion Date; or
|
8.4.2
|
in any other case, on or before the expiry of [**] months from the Completion Date.
|
8.5
|
Any Relevant Claim in respect of which notice has been given by the Buyer pursuant to clause 8.4 above shall lapse entirely if proceedings are not issued in respect of such claim within 12 months of service of the notice pursuant to clause 8.4 above, or in the case of a Relevant Claim to which clause 8.7.4 applies, within eighteen months of the date stated in clause 8.4.2 above, during which time the Buyer shall be at liberty to negotiate with the relevant party to crystallize the contingent liability into an actual liability which shall thereupon form the basis of the Relevant Claim.
|
8.6
|
The Sellers shall not be liable for a Relevant Claim to the extent that the Relevant Claim:
|
8.6.1
|
arises from facts, events or circumstances that have been Disclosed;
|
8.6.2
|
relates to a matter specifically and fully provided for in the Accounts;
|
8.6.3
|
arises from any voluntary act carried out by the Buyer or any person connected with the Buyer after Completion which is not in the ordinary course of business or pursuant to a legally binding obligation entered into or which arose prior to Completion which is required by law;
|
8.6.4
|
arises from any change in any law, rule, regulation, interpretation of the law or administrative practice of any government, governmental department, agency or regulatory body (whether or not having the force of law) or any increase in the rates, methods of calculation or scope of Taxation or any imposition of Taxation after the date of this agreement;
|
8.6.5
|
arises from any change of accounting policy or practice of the Company after Completion;
|
8.6.6
|
would not have arisen but for any claim, election, surrender or disclaimer made or omitted to be made or notice or consent given or omitted to be given by the Buyer’s Group under any Tax Statute the making or giving of which was taken into account in computing the provision for Tax (including the provision for deferred taxation) in the Accounts the Management Accounts or the Purchase Price Statement; or
|
8.6.7
|
arises from any winding-up or cessation after Completion of any business or trade carried on by the Company (other than where such occurs as a consequence of a breach of this agreement by the Sellers).
|
8.7
|
The liability of each relevant Seller for any Relevant Claim shall be reduced to the extent that:
|
8.7.1
|
there has been a corresponding saving of or credit in relation to Tax by the Buyer or any member of the Buyer's Group in respect of the loss or liability giving rise to such claim;
|
8.7.2
|
the loss or damage is recovered by the Buyer, a member of the Buyer's Group or the Company under any policy of insurance, provided that in the event that the insurance premium payable upon the renewal of the relevant insurance policy increases at the policy renewal date immediately following the date of such claim as compared to the prior premium amount paid for such policy and such increase is directly attributable to the fact of such insurance claim having been made, then any such excess over and above the prior premium amount paid for such policy shall be excluded from the protections of this clause 8.7.2;
|
8.7.3
|
it represents any liability for Tax arising in the ordinary course of business of the Company since the Accounts Date;
|
8.7.4
|
the Relevant Claim is based upon a liability which is contingent only, unless and until such contingent liability becomes an actual liability or until the same is finally adjudicated within the time period provided in clause 8.5 above (and in the event that such liability does not cease to be contingent before the expiration of such period it shall lapse);
|
8.7.5
|
provision or reserve in respect of the matter giving rise to such Relevant Claim shall have been made in the Accounts, the Management Accounts or the Purchase Price Statement (and expressly identified) or to the extent that the matter giving rise to such claim shall have been noted or taken into account in the Accounts, the Management Accounts or the Purchase Price Statement (and expressly identified);
|
8.7.6
|
any sum is received by the Company which has previously been written off as irrecoverable in the Accounts;
|
8.7.7
|
the relevant amount has previously been withheld from the Retention or otherwise recovered from the Sellers (or any of them).
|
8.8
|
In assessing any liabilities, damages or other amounts recoverable by the Buyer as a result of any Relevant Claim there shall be taken into account any amount of any Tax relief obtained or obtainable by the Buyer’s Group and any amount by which any Tax for which the Buyer’s Group is or may be liable to be assessed or accountable is reduced or extinguished, arising directly or indirectly in consequence of the matter which gives rise to such claim.
|
8.9
|
The Buyer shall not be entitled to recover more than once under this agreement in respect of the same loss or liability.
|
8.10
|
If the Sellers pay to the Buyer an amount in respect of any Relevant Claim and the Buyer or any member of the Buyer's Group subsequently recovers from another person an amount in respect of the same loss or liability the Buyer or relevant member of the Buyer's Group (as appropriate) shall as soon as reasonably practicable pay to the Sellers an amount equal to the Sum Recovered.
|
8.11
|
The Buyer shall use its best endeavours to procure that the Company preserves all documents, records, correspondence, accounts and other information whatsoever which are in the possession of the Buyer or the Company and which the Buyer and the Company in good faith believe or are aware are relevant to any Relevant Claim or potential Relevant Claim.
|
8.12
|
The Buyer shall:
|
8.12.1
|
notify each of the Sellers’ Representatives of any claim by a third party against the Company, the Buyer or any member of the Buyer’s Group which has or may give rise to a Relevant Claim (a
Third Party Claim
) as soon as reasonably practicable after the Buyer becomes aware of it; and
|
8.12.2
|
provided that such action does not constitute the waiver of legal privilege as against the relevant third party, the Buyer shall keep the Sellers’ Representatives fully informed of all developments in respect of the Third Party Claim and all acts and notices in respect thereof, consult on a regular basis in good faith with the Sellers’ Representatives as to any action to be taken in connection with that Third Party
|
8.13
|
In the event that the Sellers at any time after the date hereof shall wish to take out insurance against their liability hereunder the Buyer undertakes to provide such information as the prospective insurer may reasonably require before effecting such insurance, subject to such prospective insurer agreeing in writing to maintain the confidentiality of such information to the extent reasonably required by the Buyer.
|
8.14
|
The Buyer will take or procure the taking of all such reasonable steps and action as may be necessary or as the Sellers may require in order to mitigate any loss in respect of a Relevant Claim (for the avoidance of doubt including, but not limited to, having regard to the representations of the Sellers pursuant to clause 8.13 (Third Party Claims) above. Nothing in this agreement shall or shall be deemed to relieve the Buyer of any common law or other duty to mitigate any loss or damage incurred by it.
|
8.15
|
Save for the provisions of clause 7.10 as to the priority of liability assumed by the relevant Sellers in respect of a Relevant Claim, nothing in this clause 8 applies to exclude or limit the liability of any of the Sellers:
|
8.15.1
|
to the extent that a Relevant Claim arises or is delayed as a result of dishonesty, fraud, wilful misconduct or wilful concealment by any of the Sellers, their agents or advisers, provided that (i) such claim must be brought before the fifth anniversary of Completion and (ii) in the event that such claim arises on account of the dishonesty, fraud, wilful misconduct or wilful concealment by a Non-New Wave Seller, the Buyer acknowledges that any claim for recovery of loss arising as a result of the same shall be made first as against the Non-New Wave Sellers and if and only to the extent that it is not able to recover its loss in full from Cash Consideration, the sale of (or proceeds from the sale of) Consideration Shares, set off or repayment of either Deferred Consideration or Transfer Incentives in each case issued to or paid to the Non-New Wave Sellers, shall the New Wave Sellers have any liability in respect of any such claim; and
|
8.15.2
|
in respect of a breach of the Fundamental Warranties, provided that the maximum aggregate liability of each Seller in relation to all Fundamental Warranty Claims (inclusive of all claims, costs, expenses, reasonably incurred legal and professional fees and disbursements, VAT, interest and penalties) shall not exceed a sum equal to the aggregate of the relevant Seller's Respective Proportion of each of the unadjusted Cash Consideration (excluding any sum in respect of which
|
8.16
|
The Sellers shall not plead the Limitation Act 1980 in respect of any Tax Protection Claim.
|
8.17
|
No liability shall arise and no claim may be made in respect of a Relevant Claim to the extent that the matter giving rise to such claim is remediable, unless the Buyer shall have given written notice thereof to each of the Seller's Representatives in accordance with clause 8.5 and such matter shall not have been remedied to the reasonable satisfaction of the Buyer within the period of 30 days following the date of service of such notice.
|
9.
|
The Buyer’s Warranties
|
9.1
|
The Buyer warrants to the Sellers that, each of the following statements is true, accurate and not misleading on the date of this agreement:
|
9.1.1
|
the Buyer is duly incorporated in England & Wales;
|
9.1.2
|
the Buyer has full power and authority to enter into and perform this agreement and each of the other Transaction Documents to be entered into by it and the provisions of this agreement and each of such other Transaction Documents will, when executed, constitute valid and binding obligations on the Buyer, in accordance with their respective terms;
|
9.1.3
|
the execution and delivery of, and the performance by the Buyer of its obligations under, this agreement and each of the other Transaction Documents to which it is a party will neither:
|
9.1.3.1
|
result in a breach of any provision of its memorandum or articles or any agreement or instrument to which the Buyer or any member of the Buyer’s Group is a party or by which the Buyer or any member of the Buyer’s Group is bound; nor
|
9.1.3.2
|
result in a material breach of any law, regulation, order, judgment, licence, permit, consent or decree of any arbitral tribunal or governmental, regulatory or similar body or agency in any jurisdiction to which any member of the Buyer’s Group is a party or by which any of them or their respective assets are bound or affected;
|
9.1.4
|
there are no:
|
9.1.4.1
|
judgments, orders, injunctions or decrees of any governmental, regulatory or similar body or agency in any jurisdiction or arbitration tribunal outstanding against or affecting any member of the Buyer’s Group;
|
9.1.4.2
|
law suits, actions or proceedings pending so far as the Buyer is aware or, to the knowledge of the Buyer, threatened against or affecting any member of the Buyer’s Group; or
|
9.1.4.3
|
investigations by any governmental, regulatory or similar body or agency in any jurisdiction which are pending or, threatened against any member of the Buyer’s Group so far as the Buyer is aware,
|
9.1.5
|
No order has been made, petition presented or meeting convened for the winding up, or for the appointment of any provisional liquidator or in relation to any other process whereby the business is terminated and the assets of the Buyer or any member of the Buyer’s Group are distributed amongst the creditors and/or shareholders or other contributors, and there are no cases or proceedings under any applicable insolvency, reorganisation or similar laws in any relevant jurisdiction, and so far as the Buyer is aware, no events have occurred which, under applicable laws, would be reasonably likely to justify any such cases or proceedings;
|
9.1.6
|
Neither the Buyer nor any member of the Buyer’s Group has taken any step with a view to a suspension of payments or a moratorium of any indebtedness or has made any voluntary arrangement with any of their creditors or is insolvent or unable to pay their debts as they fall due;
|
9.1.7
|
The Buyer will have sufficient cash resources, available lines of credit or other sources of immediately available funds to enable it to fulfil all of its obligations under this agreement at Completion;
|
9.1.8
|
The directors of the Buyer will have sufficient authority for the purposes of section 551 of the CA 2006 and the AIM Rules to allot the Consideration Shares without needing any further sanction or approval by shareholders of the Buyer;
|
9.1.9
|
The issued share capital of the Buyer as at the date of this agreement consists of 70,629,352 shares of £0.01 each in the capital of the Buyer;
|
9.1.10
|
There are no other class of shares in the Buyer other than ordinary shares of £0.01 each;
|
9.1.11
|
The Consideration Shares shall be issued at Completion, subject to satisfaction of the Listing Condition, free from all Encumbrances;
|
9.1.12
|
So far as the Buyer is aware there are no matters or facts in existence which might result in the Consideration Shares being refused admission to AIM; and
|
9.1.13
|
The Buyer has complied in all material respects with all of its continuing obligations under the AIM Rules and (to the extent they apply to the Buyer) the Disclosure Guidance and Transparency Rules published by the Financial Conduct Authority.
|
9.2
|
The Buyer acknowledges that the Sellers are entering into this agreement on the basis of, and in reliance on, clause 9.1.
|
10.
|
Tax Covenant
|
11.
|
Restrictions on the Sellers
|
11.1
|
In this clause, the following words and expressions shall have the following meanings:
|
11.2
|
Restricted Business
:
any business that is or would be in competition with any part of the Business as being carried on at the Completion Date.
|
11.3
|
Restricted Customer
:
any person who is at Completion, or who has been at any time during the period of [**] immediately preceding the Completion Date, a client or customer of, or in the habit of dealing with, the Company or any of the Subsidiaries.
|
11.4
|
Restricted Person
:
any person who is at Completion
,
or who has been at any time during the period of [**] immediately preceding the Completion Date, employed or directly or indirectly engaged by the Company or any of the Subsidiaries in an executive, managerial, sales or technical role at an annual rate of remuneration (including commission, if any,)
of
not less than £[**].
|
11.5
|
Each Key Seller undertakes to each of the Buyer and the Company that he or she shall not directly or indirectly:
|
11.5.1
|
at any time during the period of 24 months commencing on the Completion Date, world wide carry on or be employed, engaged, concerned or interested in, or in any way directly assist, a Restricted Business;
|
11.5.2
|
at any time during the period of 24 months commencing on the Completion Date:
|
11.5.2.1
|
canvass, solicit or otherwise seek the custom of any Restricted Customer with a view to providing goods or services to them in competition with the Business; or
|
11.5.2.2
|
induce or attempt to induce a Restricted Customer to cease conducting business with, or to reduce the amount of business conducted with, or to vary adversely the terms upon which it conducts business with, the Company, or do any other thing which is reasonably likely to have such an effect;
|
11.5.3
|
at any time during the period of [**] commencing on the Completion Date, have any business dealings with a Restricted Customer in connection with the provision of goods or services to them in competition with the Business;
|
11.5.4
|
at any time during the period of [**] commencing on the Completion Date, induce or attempt to induce any person who is at Completion, or has been at any time during the period of [**] immediately preceding the Completion Date, a supplier of goods or services to the Company, to cease conducting business with, or to reduce the amount of business conducted with, or to vary adversely the terms upon which it conducts business with, the Company, or do any other thing which is reasonably likely to have such an effect;
|
11.5.5
|
at any time during the period of [**] commencing on the Completion Date, offer employment to, enter into a contract for the services of, or otherwise entice or attempt to entice away from the Company, any Restricted Person, or procure or facilitate in relation to a Restricted Person the making of any such offer or attempt by any other person;
|
11.6
|
Each Seller undertakes to each of the Buyer and the Company that he or she shall not directly or indirectly at any time after Completion (save in respect of any publicity issued by New Wave, with the consent of the Buyer, acting reasonably):
|
11.6.1
|
use in the course of any business:
|
11.6.1.1
|
the word "Discuva";
|
11.6.1.2
|
any trade or service mark, business or domain name, design or logo which, at Completion, is being or has been used by the Company in connection with the Business; or
|
11.6.1.3
|
anything which is, in the reasonable opinion of the Buyer, capable of confusion with any of the words, marks, names, designs or logos referred to in clause 11.6.1.1 or clause 11.6.1.2;
|
11.6.2
|
at any time after Completion, do or say anything which may be harmful to the reputation of the Company; or
|
11.6.3
|
at any time after Completion, present himself or herself (or permit himself or herself to be presented) as:
|
11.6.3.1
|
connected in any capacity with the Company (save in the normal course of their employment or engagement by the Company or the Buyer to the extent that such employment or engagement continues after Completion); or
|
11.6.3.2
|
interested or concerned in any way in the Sale Shares (or any of them).
|
11.7
|
The undertakings in clauses 11.5 and 11.6 are intended for the benefit of, and shall be enforceable by, each of the Buyer and the Company, and shall apply to actions carried out by the relevant Key Seller or Seller (as the case may be) in any capacity (including as shareholder, partner, director, principal, consultant, officer, employee, agent or otherwise) and whether directly or indirectly, on that Seller's own behalf or on behalf of, or jointly with, any other person.
|
11.8
|
Nothing in clauses 11.5 and 11.6 shall prevent any Seller from holding for investment purposes only:
|
11.8.1
|
units of any authorised unit trust; or
|
11.8.2
|
not more than 5% of any class of shares or securities of any company traded on a recognised investment exchange (within the meaning of the Financial Services and Markets Act 2000).
|
11.9
|
Each of the undertakings in clauses 11.5 and 11.6 is a separate undertaking by each Seller or Key Seller (as the case may be) in relation to himself or herself and his or her interests and shall be enforceable by the Buyer and the Company separately and independently of their right to enforce any one or more of the other undertakings contained in that clause.
|
11.10
|
The parties acknowledge that the Sellers have confidential information relating to the Business and that the Buyer is entitled to protect the goodwill of the Business as a result of buying the Sale Shares. Accordingly, each of the covenants in clause 11.6 is considered fair and reasonable by the parties.
|
11.11
|
The consideration for the covenants in clauses 11.5 and 11.6 are included in the Purchase Price.
|
11.12
|
Nothing in this clause 11 shall prevent John Wain from:
|
11.12.1
|
carrying out any work undertaken in an academic capacity, whether or not such work relates to, or would otherwise compete with, the Business, provided that he shall not, whether directly or indirectly and whether or not in his personal capacity or jointly with any other person (whether as a shareholder, partner, director, principal, consultant, agent or in any other capacity) exploit, or take steps to exploit, any such work for commercial gain or reward; or
|
11.12.2
|
in his academic capacity working with, employing or retaining as a consultant any person whom he has so worked with, employed or retained in the 2 years prior to Completion.
|
12.
|
Confidentiality and announcements
|
12.1
|
Each Seller severally undertakes to the Buyer and the Company that he or she shall:
|
12.1.1
|
keep confidential the terms of this agreement and the other Transaction Documents, and all and any confidential information, know how or trade secrets in his or her knowledge or possession concerning the business, affairs, customers, clients or suppliers of the Company or any member of the Buyer's Group (provided always that no Seller shall be prohibited from carrying out any work for Bactevo (subject to compliance by Bactevo with the Bactevo Agreements);
|
12.1.2
|
not disclose any of the information referred to in clause 12.1.1 in whole or in part to any third party, except as expressly permitted by this clause 12; and
|
12.1.3
|
not make any use of any of the information referred to in clause 12.1.1, other than to the extent necessary for the purpose of exercising or performing his or her rights and obligations under this agreement.
|
12.2
|
Each Seller undertakes to the other Sellers that they shall keep confidential the terms of this agreement and all confidential information in their knowledge or possession relating to the
|
12.3
|
The Buyer undertakes to each Seller that it shall at all times:
|
12.3.1
|
keep confidential (and the Buyer shall procure that all other members of the Buyer Group shall at all times keep confidential) the existence and provisions of, and the negotiations relating to, this agreement and any other Transaction Document;
|
12.3.2
|
keep confidential all information of a confidential nature that is received or obtained by the Buyer before Completion which relates to any Seller; and
|
12.3.3
|
shall use such confidential information only for the purposes contemplated by this agreement or any other Transaction Document or as required for the normal operation of the Company or any member of the Buyer’s Group.
|
12.4
|
No party shall be obliged to keep confidential or to restrict their use of any information that:
|
12.4.1
|
is or becomes generally available to the public other than as a result of its disclosure by such party (or any person to whom that party has disclosed the information in accordance with clause 12.5.1) in breach of this agreement; or
|
12.4.2
|
was, is or becomes available to the relevant party on a non-confidential basis from a person who, to that party’s knowledge, is not bound by a confidentiality agreement or otherwise prohibited from disclosing the information to that party.
|
12.4.3
|
was properly and lawfully in the possession of the relevant party (or such member) before the time that it was disclosed by or acquired from the other party (or, in the case of the Buyer, any other member of the Buyer Group) or its advisers.
|
12.5
|
A party may disclose any information that they are otherwise required to keep confidential under this clause 12:
|
12.5.1
|
to any of their employees, officers, consultants, representatives or advisers who need to know such information for the purposes of advising on this agreement or facilitating the Transaction or as required for the normal operation of the Company or any member of the Buyer’s Group, provided that the party making the disclosure informs the recipient of the confidential nature of the information before disclosure and procures that each recipient shall, in relation to any such information disclosed to them, comply with the obligations set out in this clause 12 as if they were that party. The party making a disclosure under this clause shall, at all times, be liable
|
12.5.2
|
with the prior consent in writing of the Buyer or the Sellers’ Representatives as appropriate;
|
12.5.3
|
if such information relates to one party only, with the prior consent in writing of that party;
|
12.5.4
|
to confirm that the Transaction has taken place, or the date of the Transaction (but without otherwise revealing any other terms of the Transaction or making any other announcement);
|
12.5.5
|
to the extent that the disclosure is required:
|
12.5.5.1
|
by the laws of any jurisdiction to which the relevant party is subject;
|
12.5.5.2
|
by an order of any court of competent jurisdiction, or any regulatory, judicial, governmental or similar body, or any Tax Authority or securities exchange of competent jurisdiction;
|
12.5.5.3
|
under any arrangement in place under which negotiations relating to terms and conditions of employment are conducted;
|
12.5.5.4
|
to make any filing with, or obtain any authorisation from, any regulatory, governmental or similar body, or any Tax Authority or securities exchange of competent jurisdiction; or
|
12.5.5.5
|
to protect the relevant party’s interest in any legal proceedings,
|
12.6
|
Each party shall supply the other parties (or any of them) with such information about itself, its Group or this agreement as they may reasonably require for the purposes of satisfying the requirements of any law or any judicial, governmental, regulatory or similar body or any Tax Authority or securities exchange of competent jurisdiction.
|
12.7
|
Subject to clause 12.8 to clause 12.10 (inclusive), no party shall make, or permit any person to make, any public announcement, communication or circular concerning this agreement or
|
12.8
|
Nothing in clause 12.7 shall prevent a party from making an announcement required by law or any governmental or regulatory authority (including any Tax Authority), any securities exchange, or any court or other authority of competent jurisdiction, provided that the party required to make the announcement consults with the other parties and takes into account their reasonable requests concerning the content of the announcement before it is made.
|
12.9
|
The parties shall issue a press release in agreed form immediately following Completion.
|
12.10
|
The Buyer may at any time after Completion, having consulted with and taken into account the reasonable requests of the Sellers’ Representatives, announce its acquisition of the Sale Shares to any employees, clients, customers or suppliers of the Company or any other member of the Buyer's Group.
|
13.
|
Further assurance
|
13.1
|
The Sellers shall (and shall use reasonable endeavours to procure that any relevant third party shall) at the Buyer’s expense promptly execute and deliver such documents and perform such acts as the Buyer may reasonably require from time to time for the purpose of giving full effect to this agreement.
|
13.2
|
Each Seller undertakes to the Buyer that, if and for so long as he or she remains the registered holder of any of the Sale Shares after Completion, he or she shall:
|
13.2.1
|
hold such Sale Shares, together with all dividends and any other distributions of profits or other assets in respect of such Sale Shares, and all rights arising out of or in connection with them, in trust for the Buyer;
|
13.2.2
|
deal with and dispose of such Sale Shares, dividends, distributions, assets and rights as the Buyer shall direct;
|
13.2.3
|
exercise all voting rights attached to such Sale Shares (including for the avoidance of doubt, signing a written resolution of members of the Company) in such manner as the Buyer shall direct; and
|
13.2.4
|
if required by the Buyer, execute all instruments of proxy or other documents as may be necessary to enable the Buyer to attend and vote at any meeting of the Company.
|
14.
|
Assignment
|
14.1
|
Subject to the further provisions of this clause 16, no party shall assign, transfer, mortgage, charge, declare a trust of, or deal in any other manner with any or all of its rights and obligations under this agreement or any other Transaction Document.
|
14.2
|
Subject to clause 14.5, the Buyer may assign or transfer its rights (but not its obligations) under this agreement (or any document referred to in this agreement) to:
|
14.2.1
|
another member of its Group for so long as that company remains a member of the Buyer's Group. The Buyer shall procure that such assignee shall comply in full with the terms of this Agreement as if it were the Buyer and that any company assigns any rights assigned to it in accordance with this clause 14 back to the Buyer or to such other member of the Buyer's Group as it may nominate immediately before that company ceases to be a member of the Buyer's Group; or
|
14.2.2
|
any person to whom the Sale Shares are sold or transferred by the Buyer following Completion,
|
14.3
|
Subject to clause 14.5, the Buyer may grant security over, or assign by way of security, any or all of its rights under this agreement or any other Transaction Document for the purposes of, or in connection with, the financing (whether in whole or in part) by the Buyer of any of its working capital or other requirements. On the enforcement of any security of a kind referred to in this clause, the Buyer, or any administrative receiver of the Buyer or any person having the benefit of such security may assign any or all of the relevant rights to any person, but the Sellers' liability to any assignee in respect of those rights shall not be greater than if no assignment had taken place.
|
14.4
|
If there is an assignment or transfer of the Buyer's rights in accordance with clause 14.2 or clause 14.3:
|
14.4.1
|
the Sellers may discharge their obligations under this agreement to the Buyer until they receive notice of the assignment or transfer; and
|
14.4.2
|
the assignee or transferee may enforce this agreement as if it were named in this agreement as the Buyer, but the Buyer shall remain liable for any obligations under this agreement.
|
14.5
|
During the period in which any Deferred Consideration may become payable the Buyer may not assign any of its rights under this agreement without the prior written consent of the Sellers' Representatives (such consent not to be unreasonably withheld) except to another member of the Buyer’s Group.
|
15.
|
No agency
|
16.
|
Entire agreement
|
17.
|
Variation and waiver
|
17.1
|
No variation of this agreement shall be effective unless it is in writing and signed by the parties (or their authorised representatives). Each of the Sellers hereby appoints the Sellers’ Representatives as his authorised representatives for such purposes.
|
17.2
|
A waiver of any right or remedy under this agreement or by law is only effective if given in writing and signed by the person waiving such right or remedy. Any such waiver shall apply only to the circumstances for which it is given and shall not be deemed a waiver of any subsequent breach or default.
|
17.3
|
A failure or delay by any person to exercise any right or remedy provided under this agreement or by law shall not constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict any further exercise of that or any other right or remedy. No single or partial exercise of any right or remedy provided under this agreement or by law shall prevent or restrict the further exercise of that or any other right or remedy.
|
17.4
|
A party that waives a right or remedy provided under this agreement or by law in relation to one party, or takes or fails to take any action against that party, does not affect its rights in relation to any other party.
|
18.
|
Sellers’ Representatives
|
18.1
|
Subject to Clause 18.4, each Seller irrevocably appoints the Sellers' Representatives (acting unanimously) as his agents:
|
18.1.1
|
to negotiate and agree and/or deal with the determination of the Deferred Consideration and the Purchase Price Statement;
|
18.1.2
|
to negotiate, compromise, agree and settle any dispute with the Buyer on his behalf; and
|
18.1.3
|
to take all actions and exercise all rights in relation to the Retention; and
|
18.1.4
|
without prejudice to clauses 18.1.1 to 18.1.3, to act on his behalf in relation to any matter which this agreement expressly provides to be agreed or done by the Sellers' Representatives.
|
18.2
|
Without prejudice to clause 18.1, each Seller irrevocably agrees that any notice, consent or agreement, election, demand or other action to be given, made or taken by such Seller (whether individually or with others) under or in connection with this agreement (including any amendment or variation of the terms of this agreement), may be given, made or taken on his behalf by the Sellers' Representatives provided that the Sellers' Representatives shall not have authority under this clause 18.2 to agree to any amendment to this agreement on behalf of a Seller unless (i) the amendment is immaterial or (ii) the amendment has been approved by a Seller Majority.
|
18.3
|
Each Seller irrevocably:
|
18.3.1
|
(subject to clause 18.4) undertakes to the Buyer that the Sellers' Representatives have and shall retain the authority to bind him in relation to the matters referred to in Clauses 18.1 and 18.2 (Relevant Matters);
|
18.3.2
|
agrees that the Buyer shall be entitled to rely on any motive or communication in writing provided by the Sellers' Representatives in relation to any Relevant Matter as binding on him; and
|
18.3.3
|
agrees that any notice or communication in writing by the Sellers' Representatives to the Buyer in relation to any Relevant Matter shall be deemed (unless the context requires otherwise) to be provided by the Sellers' Representatives as agent for all of the Sellers.
|
18.4
|
If, for any reason, a Sellers' Representative resigns (by notice in writing served on the Sellers and the Buyer) or ceases to be able to act for the purposes of this Clause 18 or no longer has a postal address in the United Kingdom, the Sellers shall immediately:
|
18.4.1
|
(subject to this Clause 18.4.1) irrevocably appoint a substitute Sellers' Representative with a postal address in the United Kingdom; and
|
18.4.2
|
notify the Buyer of the name, relevant contact (where appropriate) and postal and email addresses of the substitute Sellers' Representative.
|
18.5
|
Such appointment and notice shall be effective on the fifth Business Day after the date on which the notice given pursuant to clause 18.4.2 is deemed to have been served or delivered in accordance with clause 20.
|
18.6
|
If, on any occasion, there are no Sellers' Representatives:
|
18.6.1
|
the Buyer shall be entitled to deal with a Seller Majority instead;
|
18.6.2
|
(except in this clause 18), references in this agreement to the Sellers' Representatives shall be construed accordingly; and
|
18.6.3
|
for the purposes of clause 20, the relevant contact (where appropriate) and postal addresses of the Sellers shall be as set out in Schedule 1.
|
18.7
|
The Sellers shall be entitled (acting by a Seller Majority) to appoint any other Seller(s) to act as a replacement in place of the Sellers’ Representatives named in this agreement provided that no such appointment will take effect unless notice of the proposed appointment, setting out the full name and contact details of the new representative(s) signed by the Seller Majority, is given to the Buyer and the Sellers receive the Buyer's consent (which consent shall not be unreasonably withheld and shall be deemed to be given if a response is not received from the Buyer within 10 Business Days of notice of the intended new Sellers’ Representative(s) being given to the Buyer).
|
18.8
|
Where any Relevant Matter is an Individual Dispute, then the relevant Seller shall be entitled to be served notice directly of any such Individual Dispute and shall be entitled to deal with the conduct of the Individual Dispute himself provided that (a) that Seller shall nominate and maintain a person (who may be the Seller himself) with an address in England & Wales with authority to accept service on his behalf of Notices and process in any legal action or proceedings before the courts of England and Wales relating to or in connection with any such Individual Dispute and (b) such notice shall set out the address and other contact details of such nominated person. The Seller shall be entitled by notice to the Buyer to nominate a replacement of any such nominated person provided the replacement also has an address in
|
19.
|
Costs
|
19.1
|
Except as expressly provided in this agreement, each party shall pay its own costs and expenses incurred in connection with the negotiation, preparation and execution of this agreement (and any other Transaction Documents).
|
19.2
|
Each Seller agrees to the deduction from his entitlement to the Completion Payment
of his Respective Proportion of the Deal Fees and the Insurance Premium Contribution.
|
19.3
|
Each PropCo Seller agrees to the deduction from his entitlement to the Completion Payment of a sum equal to the par value of the shares which he holds in PropCo, which such sum shall be paid over to PropCo to satisfy the subscription monies due on such shares.
|
20.
|
Notices
|
20.1
|
For the purposes of this clause 20.1, but subject to clause 20.8, notice includes any other communication.
|
20.2
|
A notice given to a party under or in connection with this agreement:
|
20.2.1
|
shall be in writing and in English;
|
20.2.2
|
shall be signed by or on behalf of the party giving it;
|
20.2.3
|
shall be sent to the relevant party for the attention of the named contact and to the address specified in Schedule 1 or clause 20.4.2 (as the case may be), or such other named contact or address as that party may notify to the others in accordance with the provisions of this clause 20; and
|
20.2.4
|
shall be:
|
20.2.4.1
|
delivered by hand;
|
20.2.4.2
|
sent by pre-paid first class post or another next working day delivery service providing proof of postage; or
|
20.2.4.3
|
sent by airmail or by reputable international overnight courier (if the notice is to be served by post to an address outside the country from which it is sent).
|
20.3
|
Any notice to be given under this agreement to or by:
|
20.3.1
|
all of the Sellers, shall be deemed to have been properly given if it is given to or by (as the case may be) the Sellers' Representatives; or
|
20.3.2
|
some of the Sellers only, shall be given to or by (as the case may be) the relevant Seller and, in the case of a notice given to a Seller, to his address as set out in Schedule 1.
|
20.4
|
The addresses for service of notices on the Buyer, the Sellers' Representatives and New Wave Ventures LLP are:
|
20.4.1
|
Buyer
|
20.4.1.1
|
address: 136a Eastern Avenue, Milton Park, Abingdon, Oxfordshire OX14 4SB
|
20.4.1.2
|
for the attention of:
The Company Secretary
|
20.4.2
|
Sellers' Representatives at the addresses set out against their respective names as set out in Schedule 1.
|
20.4.3
|
New Wave Ventures LLP
|
20.4.3.1
|
address: Eighth Floor, 6 New Street Square, London EC4A 3AQ
|
20.4.3.2
|
for the attention of: Tim Bullock
|
20.5
|
A party may change its details for service of notices as specified in clause 20.4 or Schedule 1 (as the case may be) by giving notice to each of the other parties, provided that in the case of a change to the party's postal address for service the new address is an address in the UK. Any notice of a change to the identity of the Sellers' Representatives must be signed by or on behalf of a Seller Majority to be effective. Any change notified pursuant to this clause shall take effect at 9.00 am on the later of:
|
20.5.1
|
the date, if any, specified in the notice as the effective date for the change; and
|
20.5.2
|
five Business Days after deemed receipt of the notice of change.
|
20.6
|
Delivery of a notice is deemed to have taken place (provided that all other requirements in this clause have been satisfied):
|
20.6.1
|
if delivered by hand at the time the notice is left at the address;
|
20.6.2
|
if sent by pre-paid first class post or another next working day delivery service providing proof of postage to an address in the UK, at 9.00 am on the second Business Day after posting;
|
20.6.3
|
if sent by pre-paid airmail to an address outside the country from which it is sent, at 9.00 am on the fifth Business Day after posting;
|
20.6.4
|
if sent by reputable international overnight courier to an address outside the country from which it is sent, on signature of a delivery receipt; or
|
20.6.5
|
if deemed receipt under the previous paragraphs of this clause 20.6 would occur outside business hours (meaning 9.00 am to 5.30 pm Monday to Friday on a day that is not a public holiday in the place of deemed receipt), at 9.00 am on the day when business next starts in the place of deemed receipt. For the purposes of this clause, all references to time are to local time in the place of deemed receipt.
|
20.7
|
To prove service, it is sufficient to prove that:
|
20.7.1
|
if delivered by hand or by reputable international overnight courier, the notice was delivered to the correct address;
|
20.7.2
|
if sent by post or by airmail, the envelope containing the notice was properly addressed, paid for and posted.
|
20.8
|
This clause 20 does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution.
|
21.
|
Joint obligations
|
21.1
|
Unless expressly provided otherwise, the Sellers shall severally liable for their obligations, undertakings and liabilities under this agreement. For the avoidance of doubt the liability of the Sellers for their obligations under clause 7, clause 11, clause 12, and clause 13.2 shall be several and extend only to any loss or damage arising out of their own breaches.
|
21.2
|
The Buyer may take action against, grant time or other indulgence to, or release or compromise in whole or part the liability of, any one or more of the Sellers in respect of any warranty, indemnity, representation or other obligation under this agreement without affecting the liability of any of the other Sellers who are liable (whether jointly and severally or otherwise) in respect of that warranty, indemnity, representation or other obligation.
|
22.
|
Interest
|
22.1
|
Subject to clause 23.3
if
a party fails to make any payment due to any other party under this agreement by the due date then the defaulting party shall pay interest on the overdue sum from the due date until payment of the overdue sum, whether before or after judgment.
|
22.2
|
Interest under this clause will accrue each day at [**]% a year above the Bank of England's base rate from time to time, but at [**]% a year for any period when that base rate is below [**]%.
|
22.3
|
In relation to payments disputed in good faith, interest under this clause is payable only after the dispute is resolved, on sums found or agreed to be due, from [**]
Business D
ays after the dispute is resolved until payment.
|
23.
|
Severance
|
24.
|
Agreement survives Completion
|
25.
|
Third party rights
|
25.1
|
Except as expressly provided in clause 25.2, this agreement does not give rise to any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this agreement.
|
25.2
|
The following provisions are intended to benefit future buyers of the Sale Shares and (to the extent that they are identified in the relevant clauses as recipients of rights or benefits under that clause), the Company, and the Officers (as defined in clause 7.7), and shall be enforceable by each of them to the fullest extent permitted by law:
|
25.2.1
|
Clause 7 and Schedule 6 (Warranties) (subject to clause 8 (Limitations on claims));
|
25.2.2
|
Clause 10 and Schedule 7 (Tax Covenant);
|
25.2.3
|
Clause 11 (Restrictions on the Sellers);
|
25.2.4
|
Clause 12 (Confidentiality and announcements); and
|
25.2.5
|
Clause 22 (Interest).
|
25.3
|
The rights of the parties to rescind or vary this agreement are not subject to the consent of any other person.
|
26.
|
Counterparts
|
26.1
|
This agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement.
|
26.2
|
Transmission of an executed counterpart of this agreement (but for the avoidance of doubt not just a signature page) by email (in PDF, JPEG or other agreed format) shall take effect as delivery of an executed counterpart of this agreement. If this method of delivery is adopted, without prejudice to the validity of the agreement thus made, each party shall provide the others with the "wet-ink" original of such counterpart as soon as reasonably possible thereafter.
|
26.3
|
No counterpart shall be effective until each party has executed and delivered at least one counterpart.
|
27.
|
Rights and remedies
|
28.
|
Inadequacy of damages
|
29.
|
Governing law and jurisdiction
|
29.1
|
This agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the law of England.
|
29.2
|
Each party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with this agreement or its subject matter or formation.
|
Signed by DAVID HUGH WILLIAMS
|
|
/s/ DAVID HUGH WILLIAMS
|
|
|
|
Signed by JOHN RICHARD WAIN
|
|
/s/ JOHN RICHARD WAIN
|
|
|
|
Signed by ERNESTO GIORGIO REGGIANI
|
|
/s/ ERNESTO GIORGIO REGGIANI
|
|
|
|
Signed by KEITH TURNER
|
|
/s/ KEITH TURNER
|
|
|
|
Signed by NAWAZ KHAN
|
|
/s/ NAWAZ KHAN
|
|
|
|
Signed by CLIVE MASON
|
|
/s/ CLIVE MASON
|
|
|
|
Signed by DUNCAN MASKILL
|
|
/s/ DUNCAN MASKILL
|
|
|
|
Signed by IAN MICHAEL RIORDEN GEORGE
|
|
/s/ IAN MICHAEL RIORDEN GEORGE
|
|
|
|
Signed by TIM AVIS
|
|
/s/ TIM AVIS
|
|
|
|
Signed by PAUL MEO
|
|
/s/ PAUL MEO
|
|
|
|
Signed by SIHONG CHEN
|
|
/s/ SIHONG CHEN
|
|
|
|
Signed by CHRISTOPHER COWARD
|
|
/s/ CHRISTOPHER COWARD
|
|
|
|
Signed by ELENA BREDEINSTEIN
|
|
/s/ ELENA BREDEINSTEIN
|
|
|
|
Signed by ASHLEY POULTER
|
|
/s/ ASHLEY POULTER
|
|
|
|
Signed by DENITSA DIMITROVA
|
|
/s/ DENITSA DIMITROVA
|
|
|
|
Signed by SARAH FORDHAM
|
|
/s/ SARAH FORDHAM
|
|
|
|
Signed by CEDRIC CHARRIER
|
|
/s/ CEDRIC CHARRIER
|
|
|
|
Signed by OLUSEGUN OSHOTA
|
|
/s/ OLUSEGUN OSHOTA
|
|
|
|
Signed by JENNIFER ROBERTS
|
|
/s/ JENNIFER ROBERTS
|
|
|
|
Signed by NEW WAVE VENTURES LLP acting by a member
|
|
/s/ NEW WAVE VENTURES LLP
|
|
|
Member
|
Signed by MELISSA STRANGE for and on behalf of SUMMIT THERAPEUTICS PLC
|
|
/s/
MELISSA STRANGE
Company Secretary
|
|
|
|
|
|
|
Dated 23rd December 2017
|
The Management Team
and
Discuva Limited
|
TRANSFER INCENTIVE AGREEMENT
|
1
|
The several persons whose names and addresses are set out in the Schedule (the “
Management Team
”); and
|
2
|
Discuva Limited
a company registered in England and Wales with company number 06169490 and whose registered office is at The Merrifield Centre, Rosemary Lane, Cambridge, CB1 3LQ (the “
Company
”)
|
1
|
DEFINITIONS AND INTERPRETATION
|
1.1
|
In this agreement the following words and phrases have the following meanings:
|
1.2
|
Clause, Schedule and paragraph headings shall not affect the interpretation of this agreement.
|
1.3
|
A person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality).
|
1.4
|
The Schedule forms part of this agreement and shall have effect as if set out in full in the body of this agreement. Any reference to this agreement includes the Schedule.
|
1.5
|
A reference to a holding company or a subsidiary means a holding company or a subsidiary (as the case may be) as defined in section 1159 of the Companies Act 2006.
|
1.6
|
Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular.
|
1.7
|
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders.
|
1.8
|
This agreement shall be binding on, and enure to the benefit of, the parties to this agreement and their respective personal representatives, successors and permitted assigns, and references to any party shall include that party's personal representatives, successors and permitted assigns.
|
1.9
|
A reference to a statute or statutory provision is a reference to it as it is in force as at the date of this agreement.
|
1.10
|
A reference to a statute or statutory provision shall include all subordinate legislation made as at the date of this agreement under that statute or statutory provision.
|
1.11
|
A reference to writing or written includes neither fax nor email.
|
1.12
|
References to clauses and Schedules are to the clauses and Schedules of this agreement and references to paragraphs are to paragraphs of the relevant Schedule.
|
2
|
BASIS OF THE AGREEMENT
|
2.1
|
The Company has agreed that the Management Team shall be paid the Transfer Incentives, subject to and on the terms of this agreement.
|
2.2
|
Subject to clause 2.3:
|
2.2.1
|
on each of the first [**] occasions on which a Relevant Product achieves Milestone A Event (being a different product and trial for each event), a Milestone A Payment shall be paid to the Management Team in accordance with clause 4 apportioned between them in the sums set out in the Schedule; and
|
2.2.2
|
on each of the first [**] occasions on which a Relevant Product achieves Milestone B Event (being a different product for each event and a different Phase II Trial for each event), a Milestone B Payment shall be paid to the Management Team in accordance with clause 4 apportioned between them in the amounts set out in the Schedule.
|
2.3
|
The maximum aggregate value of all Transfer Incentive Payments payable under this agreement shall be capped at £7,908,611.60 and once such sum has been paid in accordance with clause 4 the Management Team shall have no further rights or entitlement under this agreement.
|
2.4
|
Subject to clause 2.5, the Company shall only be responsible to pay a maximum of [**] Milestone A Payments for all Milestone A Events achieved, whether or not such Milestone A Event is achieved with respect to further products or Clinical Trials. Further, Company shall only be responsible to pay a maximum of [**] Milestone B Payments for all Milestone B Events achieved, whether or not such Milestone B Event is achieved with respect to further products or Clinical Trials. For clarity Milestone A Events and Milestone B Events are not interdependent or connected, by way of example in the event that a Milestone B Event has been achieved without all Milestone A Events having been achieved, the Milestone A Payments which were not achieved shall not become automatically due and payable as a consequence.
|
2.5
|
Notwithstanding anything else in this agreement, the parties acknowledge and agree that in relation to Reversionary Roche Products certain Milestones may (but for this sub clause 2.5) trigger payments under this agreement and payments of Deferred Consideration to the Sellers under the Share Purchase Agreement. In such circumstance the parties acknowledge and agree that payments under the Share Purchase Agreement shall be due first. The parties further agree that where the Sellers have been paid in accordance with Schedule 5 of the Share Purchase Agreement in respect of a product which subsequently becomes a Reversionary Roche Product, an amount equal to such payment shall be subtracted from any Milestone Payment in respect of the Reversionary Roche Product which becomes due hereunder. The subtracted amount shall be payable upon achievement of Milestone Event(s) by the fourth (4th) or subsequent Reversionary Roche Product .
|
3
|
MANAGEMENT TEAM PROTECTIONS
|
3.1
|
For the purposes of protecting the Transfer Incentives the Company undertakes to the Management Team, subject always to clause 3.2 hereof, that:
|
3.1.1
|
the business and affairs of the Company shall be supported, operated and managed in accordance with bona fide commercial principles insofar as the interests of the Company are concerned, including, but not limited to, the fulfilment of obligations of the Company under this agreement;
|
3.1.2
|
no act or omission on the part of the Company shall take place where such act or omission is intended to and has the aim of reducing the Transfer Incentives;
|
3.1.3
|
it shall not divert or redirect any trading, business opportunities or revenues in a way that has the aim of reducing the Transfer Incentives;
|
3.1.4
|
no material change shall be made to the scope or nature of the business of the Company or the manner in which the Business is carried on where such act or omission is intended to have the effect of reducing the Transfer Incentives; and
|
3.1.5
|
no resolution to wind up the Company will be passed or proposed (save in circumstances of insolvency).
|
3.2
|
Notwithstanding the provisions of clause 3.1 above, the Company shall at all times remain free to act, or omit to act, in the manner in which its directors, acting in good faith, consider to be in the best interests of the Company, having given due consideration to all relevant factors including where appropriate its obligations under this agreement.
|
3.3
|
The Management Team may by written request to the Company on reasonable notice (but not more than [**]) request the Company to supply any information the Management Team may reasonably require to verify that the Company has complied with paragraph 3.1. Upon such request the Company shall use its reasonable endeavours to provide such information within [**] Business Days of the request, failing that the Management Team and their professional advisors shall be entitled during normal business hours and at a time agreed with the Company (acting reasonably) to inspect the relevant books and records of the Company (and any relevant member of the Company’s
Group
) and to take copies of them (provided always that the Management Team shall keep confidential any information so disclosed and may only use such information for the purposes of protecting and enforcing the rights of the Management Team pursuant to this Agreement).
|
3.4
|
Within [**] days of the end of each financial year the Company shall deliver to the Management Team a certificate signed by an officer of the Company confirming the Transfer Incentive Payments paid in such financial year (together with the cumulative aggregate of Transfer Incentive Payments paid since the date of this agreement), any Transfer Incentive Payments expected in the forthcoming financial year and whether the Company has complied with the obligations set out in paragraph 3.1 above. The Management Team shall be entitled to submit questions or requests for clarification within [**] Business Days of the delivery of such report, which the Company shall, so far as reasonable, respond to within [**] Business Days of receipt. It is recognised that matters relevant to such certificate and questions may be commercially sensitive and the Company shall be entitled to redact or exclude names or figures, provided that it shall use its reasonable endeavours to submit a report that permits the Management Team to make an assessment on the performance of the Relevant Products and the Transfer Incentive Payments likely to be paid.
|
4
|
PAYMENT AND TAX TREATMENT
|
4.1
|
Any Transfer Incentive Payment due shall be paid by the Company on the next normal payroll date of the Company not less than [**] days following the date on which such Transfer Incentive Payment becomes due pursuant to clause 2.2.
|
4.2
|
Any Transfer Incentive Payment payable to an Employee shall (for so long as each such person remains an employee of the Company) be paid through the Company’s payroll and shall be paid net of all relevant deductions for PAYE and employee national insurance contributions.
|
4.3
|
Any Transfer Incentive Payment payable to a Consultant (or any Employee who shall subsequently cease to be an employee of the Company) shall be paid in accordance with the legislation applicable at the time, the Company having at that time taken advice from suitably qualified tax advisers as to its obligations to retain any monies and account for such retention to the relevant tax authorities (a copy of which such advice the Consultant or Employee (as the case may be) shall be entitled to see and, to the extent it contains incorrect information about his positon, make comments which the Company shall have reasonable regard to in making its determination). Subject to such retention, and to the extent that the payment is made gross, the Consultant (or any Employee who has ceased to be an employee of the Company, as the case may be) shall be solely responsible for the payment to HMRC of any tax, national insurance contributions or other taxes arising from payment of the Transfer Incentive Payments and shall indemnify the Company in respect of any claims by HMRC against the Company in respect of demands for tax and national insurance contributions relating to the relevant Transfer Incentive Payment.
|
5
|
NOTICES
|
5.1
|
Any notice or other communication given to a party under or in connection with this agreement shall be in writing and shall be delivered by hand or by pre-paid first-class post or other next working day delivery service at its registered office (in the case of the Company) or the address set out next to their respective names in the Schedule (in the case of the Management Team) or to such other address as is otherwise notified in writing to the other parties.
|
5.2
|
Any notice or communication shall be deemed to have been received:
|
5.2.1
|
if delivered by hand or at the time the notice is left at the proper address; and
|
5.2.2
|
if sent by pre-paid first-class post or other next working day delivery service, at 9.00 am on the second Business Day after posting or at the time recorded by the delivery service.
|
5.3
|
This clause does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution.
|
5.4
|
A notice given under this agreement is not valid if sent by email.
|
6
|
GENERAL
|
6.1
|
The agreement comprises the entire agreement and understanding between the Company and the Management Team in relation to its subject matter and is in substitution for and supersedes all previous agreements or arrangements, understandings or correspondence between the Company and the Management Team relating to this or similar subject matter.
|
6.2
|
The agreement shall be binding on each party’s successors, permitted assigns and personal representatives (as the case may be).
|
6.3
|
No failure or delay by a party to exercise any right or remedy provided under this agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall prevent or restrict the further exercise of that or any other right or remedy.
|
6.4
|
No variation of this agreement shall be effective unless it is in writing and signed by the parties.
|
6.5
|
This agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement.
|
6.6
|
Unless it expressly states otherwise, this agreement does not give rise to any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this agreement.
|
6.7
|
This agreement and any disputes arising out of or in connection with its subject matter or formation (including non-contractual disputes and claims) shall be governed by and construed in accordance with the laws of England and the parties hereby submit to the exclusive jurisdiction of the courts of England and Wales.
|
EXECUTED AS A DEED
by:
DISCUVA LIMITED
acting by one director
|
)
)
)
|
/s/ John Wain
|
|
|
|
In the presence of:
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
EXECUTED AS A DEED
by:
DAVID WILLIAMS
In the presence of:
|
)
)
)
|
/s/ David Williams
|
|
|
|
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
EXECUTED AS A DEED
by:
JOHN WAIN
In the presence of:
|
)
)
)
|
/s/ John Wain
|
|
|
|
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
EXECUTED AS A DEED
by:
CLIVE MASON
In the presence of:
|
)
)
)
|
/s/ Clive Mason
|
|
|
|
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
EXECUTED AS A DEED
by:
NAWAZ KHAN
In the presence of:
|
)
)
)
|
/s/ Nawaz Khan
|
|
|
|
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
EXECUTED AS A DEED
by:
ERNESTO REGGIANI
In the presence of:
|
)
)
)
|
/s/ Ernesto Reggiani
|
|
|
|
|
|
|
Witness signature:
|
|
/s/ Jenny Laguoa
|
Witness name:
|
|
Jenny Laguoa
|
Witness address:
|
|
Taylor Vitners Solicitors
|
|
|
Merlin Place, Milton Road
|
|
|
Cambridge CB4 0DP
|
|
|
|
Witness occupation:
|
|
Trainee Solicitor
|
Name
|
Address
|
Part of Milestone A Payments
|
Part of Milestone B Payments
|
David Williams
|
[**]
|
[**]
|
[**]
|
John Wain
|
[**]
|
[**]
|
[**]
|
Clive Mason
|
[**]
|
[**]
|
[**]
|
Nawaz Khan
|
[**]
|
[**]
|
[**]
|
Ernesto Reggiani
|
[**]
|
[**]
|
[**]
|
THIRD VARIATION AGREEMENT
relating to the Agreement for the Sponsorship of a Research Programme for the development of small molecule modulators of utrophin for the treatment of Duchenne Muscular Dystrophy dated 22 November 2013
|
(1)
|
THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
, whose administrative office is at University Offices, Wellington Square, Oxford, OX1 2JD (the "
University
"); and
|
(2)
|
SUMMIT THERAPEUTICS PLC
, a public limited company incorporated in England and Wales with company number 05197494 whose address is 85b Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY (the "
Sponsor
"); and
|
(3)
|
OXFORD UNIVERSITY INNOVATION LIMITED,
a private limited company incorporated in England and Wales with company number 02199542, whose registered office is at University Offices, Wellington Square, Oxford, OX1 2JD ("
OUI
"),
|
(A)
|
The Parties entered into an agreement for the sponsorship of a research programme relating to the development of small molecule modulators of utrophin for the treatment of Duchenne Muscular Dystrophy dated 22 November 2013 (the "
Agreement
").
|
(B)
|
The Agreement was amended by way of a variation dated 16 July 2014 (the "
Variation Agreement
").
|
(C)
|
The Agreement was further amended by way of a variation dated 16 November 2015 (the “
Second Variation Agreement
”).
|
(D)
|
On 16 June 2016, Isis Innovation Limited changed its name to Oxford University Innovation Limited.
|
(E)
|
The Parties now wish to increase the level of research support and funding by: (i) £[**] to allow the University to employ [**]; (ii) £[**] to provide for the reimbursement of equipment to the University; and (iii) £[**] to allow an [**] to be employed for [**].
|
1.
|
DEFINITIONS AND INTERPRETATIONS
|
1.1
|
The terms defined in the Agreement shall have the same meanings when used in this Third Variation Agreement unless specifically indicated otherwise.
|
1.2
|
A reference to this Third Variation Agreement shall include any Schedules.
|
1.3
|
The words "
include
", "
including
", or "
in particular
" are deemed to have the words "without limitation" following them.
|
2.
|
VARIATION
|
2.1
|
With effect from the Variation Date of this Third Variation Agreement, the Parties agree the following amendments to the Agreement:
|
3.
|
GOVERNING LAW AND JURISDICTION
|
3.1
|
This Third Variation Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.
|
3.2
|
The Parties irrevocably agree that the courts of England and Wales have exclusive jurisdiction to settle any dispute or claim arising out of in connection with this Third Variation Agreement or its subject matter or its formation (including non-contractual disputes or claims).
|
SIGNED
for and on behalf of
THE CHANCELLOR MASTERS AND
SCHOLARS OF THE UNIVERSITY
OF OXFORD
:-
Name: Dr. Dan Blakey
Title: Deputy Head of Research Services (Science Area) University of Oxford
Date: 14 Sept 2017
|
)
)
)
)
|
|
/s/ Dr. Dan Blakey
____________________________
|
SIGNED
for and on behalf of
SUMMIT THERAPEUTICS PLC
:-
Name: Glyn Edwards
Title: Chief Executive Officer
Date: 20 Sept 2017
|
)
)
)
|
|
/s/ Glyn Edwards
____________________________
|
SIGNED
for and on behalf of
OXFORD UNIVERSITY INNOVATION LIMITED
:-
Name: Dr. Adam Stoten
Title: Chief Operating Officer
Date: 15 Sept 2017
|
)
)
)
|
|
/s/ Dr. Adam Stoten
____________________________
|
Dated: 22 December 2017
|
MERRIFIELD CENTRE LTD
and
DISCUVA LIMITED
|
LEASE
relating to
part of The Merrifield Centre, Rosemary Lane, Cambridge, CB1 3LQ
|
1
|
MERRIFIELD CENTRE LTD
incorporated and registered in England and Wales with company number 11118349 whose registered office is at The Merrifield Centre, Rosemary Lane, Cambridge, United Kingdom, CB1 3LQ (the "
Landlord
"); and
|
2
|
DISCUVA LIMITED
incorporated and registered in England and Wales with company number 06169490 whose registered office is at The Merrifield Centre, Rosemary Lane, Cambridge, CB1 3LQ (the "
Tenant
").
|
1
|
INTERPRETATION
|
1.1
|
Definitions:
|
1.1.1
|
"
Act of Insolvency
" means
|
1.1.1.1
|
the taking of any step in connection with any voluntary arrangement or any other compromise or arrangement for the benefit of any creditors of the Tenant or any guarantor;
|
1.1.1.2
|
the making of an application for an administration order or the making of an administration order in relation to the Tenant or any guarantor;
|
1.1.1.3
|
the giving of any notice of intention to appoint an administrator, or the filing at court of the prescribed documents in connection with the appointment of an administrator, or the appointment of an administrator, in any case in relation to the Tenant or any guarantor;
|
1.1.1.4
|
the appointment of a receiver or manager or an administrative receiver in relation to any property or income of the Tenant or any guarantor;
|
1.1.1.5
|
the commencement of a voluntary winding-up in respect of the Tenant or any guarantor, except a winding-up for the purpose of amalgamation or reconstruction of a solvent company in respect of which a statutory declaration of solvency has been filed with the Registrar of Companies;
|
1.1.1.6
|
the making of a petition for a winding-up order or a winding-up order in respect of the Tenant or any guarantor;
|
1.1.1.7
|
the striking-off of the Tenant or any guarantor from the Register of Companies or the making of an application for the Tenant or any guarantor to be struck-off;
|
1.1.1.8
|
the Tenant or any guarantor otherwise ceasing to exist (but excluding where the Tenant or any guarantor dies);
|
1.1.1.9
|
the making of an application for a bankruptcy order, the presentation of a petition for a bankruptcy order or the making of a bankruptcy order against the Tenant or any guarantor; or
|
1.1.1.10
|
the levying of any execution or other such process on or against, or taking control or possession of, the whole or any part of the Tenant's assets.
|
1.1.2
|
"
Annual Rent
" means a rate of £204,012.50 per annum (exclusive of VAT) as revised pursuant to Schedule 1.
|
1.1.3
|
"
Building
" means The Merrifield Centre, Rosemary Lane, Cambridge CB1 3LQ shown edged blue on Plan 2 registered under title number CB192579
|
1.1.4
|
"Car Park"
means the car park tinted blue on Plan 3.
|
1.1.5
|
"
CDM Regulations
" means the Construction (Design and Management) Regulations 2015 (
SI 2015/51
).
|
1.1.6
|
"
Common Parts
" means all Service Media used or capable of being used in common with other parts of the Building and those parts of the Building used in common with others necessary for access, use and enjoyment of the Property including but not limited to the server room, the plant room, the internal storage room, reception, meeting rooms and the board room as identified on Plan 1 together with the Car Park.
|
1.1.7
|
Contaminated Land Regime:
the contaminated land regime under Part 2A of the Environmental Protection Act 1990 as amended from time to time)
and any statutory instrument, circular or guidance issued under it.
|
1.1.8
|
"
Contractual Term
" means a term of four years beginning on, and including the date of this lease and ending on, and including 21 December, 2021.
|
1.1.9
|
"
Default Interest Rate
" means 4 % per annum above the Interest Rate.
|
1.1.10
|
"
Energy Assessor
" means an individual who is a member of an accreditation scheme approved by the Secretary of State in accordance with regulation 22 of the Energy Performance of Buildings (England and Wales) Regulations 2012 (SI 2012/3118) or regulation 30 of the Building Regulations 2010 (SI 2010/2214).
|
1.1.11
|
"
Energy Performance Certificate
" means a certificate as defined in regulation 2(1) of the Energy Performance of Buildings (England and Wales) Regulations 2012 (SI 2012/3118).
|
1.1.12
|
Enforcing Authority:
the relevant regulator for the Property under the Contaminated Land Regime.
|
1.1.13
|
Environment:
the natural and man-made environment including all or any of the following media, namely air, water and land (including air within buildings and other natural or man-made structures above or below the ground) and any living organisms (including man) or systems supported by those media.
|
1.1.14
|
Environmental Law:
all applicable laws, statutes, secondary legislation, bye-laws, common law, directives, treaties and other measures, judgments and decisions of any court or tribunal, and legally binding codes of practice and guidance notes (as amended from time to time) in so far as they relate to the protection of the Environment.
|
1.1.15
|
Estimated Service Charge:
means the estimated service charge referred to in clause 7.6.
|
1.1.16
|
Hazardous Substances:
any material, substance or organism which, alone or in combination with others, is capable of causing harm to the Environment or which is likely to cause an actionable nuisance.
|
1.1.17
|
"
Insurance Rent
" means the aggregate in each year of:
|
1.1.17.1
|
the Tenant's Proportion of the gross cost of the premium before any discount for the insurance of the Building (but giving credit to the Tenant for any commission payable for the insurance of the Building), for its full reinstatement cost (taking inflation of building costs into account) against loss or damage by or in consequence of the Insured Risks, including costs of demolition, site clearance, site protection and shoring-up, professionals’ and statutory fees and incidental expenses, the cost of any work which may be required under any law and VAT in respect of all those costs, fees and expenses, and public liability insurance in relation to the Common Parts;
|
1.1.17.2
|
the gross cost of the premium before any discount (but giving credit to the Tenant for any commission payable for the insurance of the Building) for insurance for loss of Annual Rent from the Property for not less than 3 years; and
|
1.1.17.3
|
any insurance premium tax payable on the above.
|
1.1.18
|
"
Insured Risks
" means fire, explosion, lightning, earthquake, storm, flood, bursting and overflowing of water tanks, apparatus or pipes, impact by aircraft and articles dropped from them, impact by vehicles, subsidence, ground slip, heave, riot, civil commotion and any other risks against which the Landlord decides to insure against from time to time and Insured Risk: means any one of the Insured Risks.
|
1.1.19
|
"
Interest Rate
" means the base rate from time to time of Barclays Bank, or if that base rate stops being used or published then a comparable commercial rate reasonably determined by the Landlord.
|
1.1.20
|
"
Lettable Unit
" means a part of the Building other than the Property that is let or capable of being let and occupied on terms similar to those of this lease.
|
1.1.21
|
"
LTA 1954
" means Landlord and Tenant Act 1954.
|
1.1.22
|
"
Permitted Use
" means offices and laboratory within Use Classes B1, B2 or D1 of the Town and Country Planning (Use Classes) Order 1987 as at the date this lease is granted.
|
1.1.23
|
"
Plan 1
" means the plan attached to this lease marked "Plan 1".
|
1.1.24
|
"
Plan 2
" means the plan attached to this lease marked "Plan 2".
|
1.1.25
|
"Plan 3"
means the plan attached to this lease marked "Plan 3".
|
1.1.26
|
"
Property
" means the part of the of the Building (the floor plan of which is shown edged red on Plan 1) bounded by and including:
|
1.1.26.1
|
the floor screed;
|
1.1.26.2
|
the ceiling plasterboard;
|
1.1.26.3
|
the interior plasterwork and finishes of exterior walls and columns;
|
1.1.26.4
|
the plasterwork and finishes of the interior structural walls and columns that adjoin another Lettable Unit or the Common Parts;
|
1.1.26.5
|
the doors and windows within the interior, structural walls and columns that adjoin another Lettable Unit or the Common Parts and their frames and fittings;
|
1.1.26.6
|
one half of the thickness of the interior, non-structural walls and columns that adjoin another Lettable Unit or the Common Parts;
|
1.1.26.7
|
the doors and windows within the interior, non-structural walls and columns that adjoin the Common Parts and their frames and fittings; and
|
1.1.26.8
|
the Landlord’s fixtures and fittings including but not limited to the laboratory benches, the laboratory shelving and cupboards;
|
1.1.26.9
|
all Service Media exclusively serving the Property within the Building;
|
1.1.26.10
|
the windows in the exterior walls and their frames and fittings;
|
1.1.26.11
|
the whole of the interior load-bearing walls and columns within that part of the Building other than their plasterwork and other than the doors and windows and their frames and fittings within such walls; and
|
1.1.26.12
|
all Service Media within the Building but which do not exclusively serve the Property.
|
1.1.27
|
"
Recommendation Report
" means a report as defined in regulation 4 of the Energy Performance of Buildings (England and Wales) Regulations 2012 (SI 2012/3118).
|
1.1.28
|
"
Rent Commencement Date
" means 22 December, 2017.
|
1.1.29
|
"
Rent Payment Dates
" means 25 March, 24 June, 29 September and 25 December.
|
1.1.30
|
"
Reservations
" means all of the rights excepted, reserved and granted to the Landlord by this lease.
|
1.1.31
|
“Schedule of Condition
: means the Schedule of Condition annexed hereto at the date of this lease and following completion of the Works the revised schedule of condition referred to in Schedule 1 which will be prepared and signed by or on behalf of both parties hereto and referable to this Lease.
|
1.1.32
|
"
Service Charge
" means the Tenant’s Proportion of the Service Costs.
|
1.1.33
|
"
Service Charge Year
" means the annual accounting period relating to the Services and the Service Costs beginning on the date hereof and each subsequent year during the term or as notified to the Tenant by the Landlord in writing.
|
1.1.34
|
"
Service Costs
" means the costs listed in
clause 7.2
.
|
1.1.35
|
"
Service Media
" means all media for the supply or removal of heat, electricity, gas, water, sewage, air-conditioning, energy, telecommunications, data and all other services and utilities and all structures, machinery and equipment ancillary to those media.
|
1.1.36
|
"
Services
" means the services listed in
clause 7.1
.
|
1.1.37
|
“SPA”
means the Share Purchase Agreement dated 22 December, 2017 and made between D Williams and Other (1) and Marmalada PLC (2)
|
1.1.38
|
"
Tenant’s Proportion
" means a fair and proper proportion determined by the Landlord acting reasonably.
|
1.1.39
|
"
Third Party Rights
" means all rights, covenants and restrictions affecting the Building including the matters referred to at the date of this lease in the property register of title number CB192579.
|
1.1.1
|
"
Uninsured Risk
"
means any risk which is not an Insured Risk or any risk(s) which the Landlord is unable to insure against because such insurance is not readily available in the insurance market or the cost of obtaining cover against such risk(s) is unreasonably high or the terms of such insurance cover are subject to unreasonable conditions or the risk(s) for which cover is sought is excluded under the terms of the insurance policy.
|
1.1.40
|
"
VAT
" means value added tax chargeable under the VATA 1994 and any similar replacement tax and any similar additional tax.
|
1.1.41
|
"
VATA 1994
" means Value Added Tax Act 1994.
|
1.1.42
|
"
Works
" means the Landlord’s Works as described in Schedule 1.
|
1.2
|
A reference to this "
lease
", except a reference to the date of this lease or to the grant of this lease, is a reference to this deed and any deed, licence, consent, approval or other instrument supplemental to it.
|
1.3
|
A reference to the "
Landlord
" includes a reference to the person entitled to the immediate reversion to this lease. A reference to the "
Tenant
" includes a reference to its successors in title and assigns. A reference to a "
guarantor
" is a reference to any guarantor of the tenant covenants of this lease including a guarantor who has entered into an authorised guarantee agreement.
|
1.4
|
In relation to any payment, a reference to a "
fair proportion
" is to a fair proportion of the total amount payable, determined by the Landlord acting reasonably.
|
1.5
|
The expressions "
landlord covenant
" and "
tenant covenant
" each has the meaning given to it by the Landlord and Tenant (Covenants) Act 1995.
|
1.6
|
Unless the context otherwise requires, references to the "
Building
", the "
Common Parts
", a "
Lettable Unit
" and the "
Property
" are to the whole and any part of them or it.
|
1.7
|
The expression "
neighbouring property
" does not include the Building.
|
1.8
|
A reference to the "
term
" is to the Contractual Term.
|
1.9
|
A reference to the "
end of the term
" is to the end of the term however it ends.
|
1.10
|
References to the "
consent
" of the Landlord are to the consent of the Landlord given in accordance with
clause 33.5
and references to the "
approval
" of the Landlord are to the approval of the Landlord given in accordance with
clause 33.6
.
|
1.11
|
A "
working day
" is any day which is not a Saturday, a Sunday, a bank holiday or a public holiday in England.
|
1.12
|
A reference to laws in general is a reference to all local, national and directly applicable supra-national laws as amended, extended or re-enacted from time to time and shall include all subordinate laws made from time to time under them and all orders, notices, codes of practice and guidance made under them.
|
1.13
|
Unless otherwise specified, a reference to a statute or statutory provision is a reference to it as amended, extended or re-enacted from time to time and shall include all subordinate legislation made from time to time under that statute or statutory provision and all orders, notices, codes of practice and guidance made under it.
|
1.14
|
Any obligation on the Tenant not to do something includes an obligation not to allow that thing to be done and an obligation to use best endeavours to prevent that thing being done by another person.
|
1.15
|
Unless the context otherwise requires, any words following the terms "
including
", "
include
",
in particular
,
for example
or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.
|
1.16
|
A "
person
" includes a natural person, corporate or unincorporated body (whether or not having separate legal personality).
|
1.17
|
A reference to
writing
or
written
does not include fax or email
|
1.18
|
Unless the context otherwise requires, references to clauses and Schedules are to the clauses and Schedules of this lease and references to paragraphs are to paragraphs of the relevant Schedule.
|
1.19
|
Clause, Schedule and paragraph headings shall not affect the interpretation of this lease.
|
1.20
|
Unless the context otherwise requires, a reference to one gender shall include a reference to the other genders.
|
1.21
|
Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular.
|
2
|
GRANT
|
2.1
|
The Landlord lets with full title guarantee the Property to the Tenant for the Contractual Term.
|
2.2
|
The grant is made together with the ancillary rights set out in
clause 3
, excepting and reserving to the Landlord the rights set out in
clause 4
, and subject to the Third Party Rights.
|
2.3
|
The grant is made with the Tenant paying the following as rent to the Landlord:
|
2.3.1
|
the Annual Rent and all VAT in respect of it;
|
2.3.2
|
the Estimated Service Charge and all VAT in respect of it;
|
2.3.3
|
the Insurance Rent;
|
2.3.4
|
all interest payable under this lease; and
|
2.3.5
|
all other sums due under this lease (but not any Service Charge in excess of the Estimated Service Charge).
|
3
|
ANCILLARY RIGHTS
|
3.1
|
The Landlord grants the Tenant the following rights (the "
Rights
"):
|
3.1.1
|
the right to support and protection from the Building ;
|
3.1.2
|
the right of free passage of water soil gas electricity telecommunication data and other services through drains sewers channels and other conducting media serving the Property which pass through over or under any other part of the Building or the
|
3.1.3
|
the right of way on foot only for the purposes of access to and egress from the Property the board room and the meeting rooms( referred to in clause 3.1.8 )and the lavatories (referred to in clause 3.1.7) for the benefit of the Tenant and those authorised by the Tenant in common with the Landlord other persons having a like right all other persons authorised by the Landlord and other tenants of the Building over and along the Common Parts affording access or leading to or from the streets abutting the Building;
|
3.1.4
|
the right to park private cars or motorbikes belonging to the Tenant, its employees and visitors within the Car Park on a first come first served basis or any other additional area as the Landlord shall from time to time nominate and notify to the Tenant;
|
3.1.5
|
the right to use the area designated by the Landlord ( acting reasonably) as notified to the Tenant for keeping bicycles belonging to the Tenant, its employees and visitors on a first come first served basis or any other additional area as the Landlord shall from time to time nominate and notify to the Tenant;
|
3.1.6
|
the right to dispose of rubbish in such rubbish disposal area within the Building as may from time to time be designated (acting reasonably) by the Landlord;
|
3.1.7
|
the right to use the lavatories and washrooms in the Common Parts;
|
3.1.8
|
subject to availability, the right to use the board room and meeting rooms in the Common Parts it being hereby acknowledged that the Landlord and the Tenant shall co-operate with each other to try to ensure that each has a fair and reasonable share of the use of the board room and the meeting rooms;
|
3.1.9
|
the right to use and to connect into any Service Media at the Building that belong to the Landlord and serve (but do not form part of) the Property which are in existence at the date of this lease or are installed or constructed during the Contractual Term;
|
3.1.10
|
the right to attach any item to the Common Parts adjoining the Property so far as is reasonably necessary to carry out any works to the Property required or permitted by this lease;
|
3.1.11
|
the right to display the name and logo of the Tenant on a sign or noticeboard provided by the Landlord in the Building and on the Common Parts at the entrance to the Property, in each case in a form and manner approved by the Landlord such approval not to be unreasonably withheld or delayed; and
|
3.1.12
|
the right to enter the Common Parts or any other Lettable Unit so far as is reasonably necessary to carry out any works to the Property required or permitted by this lease.
|
3.2
|
The Rights are granted in common with the Landlord and any other person authorised by the Landlord.
|
3.3
|
The Rights are granted subject to the Third Party Rights insofar as the Third Party Rights affect the Common Parts and the Tenant shall not do anything that may interfere with any Third Party Right.
|
3.4
|
The Tenant shall exercise the Rights (other than the Right mentioned in
clause 3.1.1
) only in connection with its use of the Property for the Permitted Use and in accordance with any regulations made by the Landlord as mentioned in
clause 23.1
.
|
3.5
|
The Tenant shall comply with all laws relating to its use of the Common Parts pursuant to the Rights.
|
3.6
|
In relation to the Rights mentioned in
clause 3.1.2
to
clause 3.1.7
, the Landlord may, at its discretion, change the route of any means of access to or egress over the Common Parts to and from the Property and may change the area within the Common Parts over which any of those Rights are exercised provided that in both cases the Landlord (a) acts reasonably in so doing and (b) provides alternative means of access and egress and an area for the exercise of the Rights no less commodious than those enjoyed at the date hereof.
|
3.7
|
In relation to the Rights mentioned in
clause 3.1.4
and
clause 3.1.6
the Landlord may from time to time designate (acting reasonably in so doing) within the Common Parts the spaces or bins (as the case may be) in respect of which the Tenant may exercise that Right.
|
3.8
|
In relation to the Rights mentioned in
clause 3.1.9
, the Landlord may, at its discretion (acting reasonably), re-route or replace over the Common Parts any such Service Media and that Right shall then apply in relation to the Service Media as re-routed or replaced.
|
3.9
|
In relation to the Right mentioned in
clause 3.1.10
, where the Tenant requires the consent of the Landlord to carry out the works to the Property, the Tenant may only exercise that Right when that consent has been granted and in accordance with the terms of that consent.
|
3.10
|
In exercising the rights of entry and/or the carrying out of any works pursuant to those rights mentioned in
clauses 3.1.2 and 3.1.12
, the Tenant shall:
|
3.10.1
|
except in case of emergency (when no notice need be given), give reasonable written notice to the Landlord and any occupiers of the relevant Lettable Unit(s) of its intention to exercise that Right;
|
3.10.2
|
where reasonably required by the Landlord or the occupier of the relevant Lettable Unit(s), exercise that Right only if accompanied by a representative of the Landlord and/or the tenant and/or the occupier of the relevant Lettable Unit(s);
|
3.10.3
|
cause as little interference and/or damage as reasonably practicable to the Common Parts and the other Lettable Units and to any property belonging to or used by the Landlord or the tenants or occupiers of the other Lettable Units;
|
3.10.4
|
cause as little inconvenience as reasonably practicable to the Landlord and the tenants and occupiers of the other Lettable Units as is reasonably practicable; and
|
3.10.5
|
promptly make good at its own cost (to the proper satisfaction of the Landlord) any damage whatsoever caused by reason of the Tenant exercising that Right.
|
3.11
|
Except as mentioned in this
clause 3
, neither the grant of this lease nor anything in it confers any right over the Common Parts or any Lettable Unit or any neighbouring property nor is to be taken to show that the Tenant may have any right over the Common Parts or any Lettable Unit or any neighbouring property, and section 62 of the Law of Property Act 1925 does not apply to this lease.
|
4
|
RIGHTS EXCEPTED AND RESERVED
|
4.1
|
The following rights are excepted and reserved from this lease to the Landlord and those reasonably and properly authorised by the Landlord for the benefit of the Building:
|
4.1.1
|
rights of light, air, support and protection to the extent those rights are capable of being enjoyed at any time during the Contractual Term;
|
4.1.2
|
the right of free passage and running of water and soil in and through the sewers drains and channels made or to be made upon through or under the Property and
|
4.1.3
|
the right to use, lay new and connect into Service Media at, but not forming part of, the Property which are in existence at the date of this lease or which are installed or constructed during the Contractual Term the right to install and construct Service Media at the Property to serve any part of the Building (whether or not such Service Media also serve the Property); and the right to re-route any Service Media mentioned in this clause;
|
4.1.4
|
the right of access to or egress over the Property to the Common Parts for all purposes;
|
4.1.5
|
the right to erect scaffolding at the Property or the Building and attach it to any part of the Property or the Building in connection with any of the Reservations;
|
4.1.6
|
the right to attach any structure, fixture or fitting to the boundary of the Property in connection with any of the Reservations;
|
4.1.7
|
the right to re-route any means of access to or egress from the Property or the Building and to change the areas over which the Rights mentioned in
clause 3.1.1
to
clause 3.1.7
are exercised;
|
4.1.8
|
the right to re-route and replace any Service Media over which the Rights mentioned in
clause 3.1.9
are exercised; and
|
4.1.9
|
the right to build or rebuild or alter any adjacent or neighbouring land or buildings in any manner whatsoever and to let the same for any purpose or otherwise deal therewith provided that the light and air to the Property are not in any such case thereby diminished and that no other liberty easement right or advantage belonging to the Tenant is thereby diminished or prejudicially affected.
|
4.2
|
The Landlord reserves the right to enter the Property:
|
4.2.1
|
to repair, maintain, install, construct, re-route or replace any Service Media or structure relating to any of the Reservations;
|
4.2.2
|
to carry out any works to any other Lettable Unit; and
|
4.2.3
|
for any other purpose mentioned in or connected with:
|
4.2.3.1
|
this lease;
|
4.2.3.2
|
the Reservations; and
|
4.2.3.3
|
the Landlord’s interest in the Property or the Building.
|
4.3
|
The Reservations may be exercised by the Landlord and by anyone else who is or becomes entitled to exercise them, and by anyone properly and reasonably authorised by the Landlord.
|
4.4
|
The Tenant shall allow all those entitled to exercise any right to enter the Property, to do so with their workers, contractors, agents and professional advisors, and to enter the Property at any reasonable time (whether or not during usual business hours) and, except in the case of an emergency, after having given reasonable notice in writing to the Tenant.
|
4.5
|
PROVIDED THAT the Landlord shall cause as little interference as is reasonably practicable to the Tenant’s beneficial use and enjoyment of the Property in the exercise of the rights referred to in this clause 4 and shall make good promptly at its own cost and to the Tenant’s proper satisfaction expressed in writing any damage caused by or because of the exercise of such rights to the Property and/or to the Tenant’s fixtures and fittings and/or to the Tenant’s chattels
|
5
|
THIRD PARTY RIGHTS
|
5.1
|
The Tenant shall comply with all obligations on the Landlord relating to the Third Party Rights insofar as those obligations relate to the Property and shall not do anything (even if otherwise permitted by this lease) that may interfere with any Third Party Right.
|
5.2
|
The Tenant shall allow the Landlord and any other person authorised by the terms of the Third Party Right to enter the Property in accordance with its terms.
|
6
|
THE ANNUAL RENT
|
6.1
|
The Tenant shall pay the Annual Rent and any VAT in respect of it by four equal instalments in advance on or before the Rent Payment Dates. The payments shall be made by banker’s standing order or by any other method (but not by direct debit) that the Landlord requires at any time by giving notice to the Tenant.
|
6.2
|
The first instalment of the Annual Rent and any VAT in respect of it shall be made on the date of this lease and shall be the proportion, calculated on a daily basis,
|
7
|
SERVICES AND SERVICE CHARGE
|
7.1
|
The "
Services
" are:
|
7.1.1
|
cleaning, maintaining, decorating and repairing the Common Parts, including the structural parts of the Building and all Service Media forming part of the Common Parts provided that, in respect of cleaning windows, the Landlord's obligation is limited to cleaning the outside of the windows of the Building;
|
7.1.2
|
lighting the Common Parts and cleaning, maintaining, repairing and replacing lighting machinery and equipment on the Common Parts;
|
7.1.3
|
cleaning, maintaining, repairing and replacing refuse bins on the Common Parts;
|
7.1.4
|
cleaning, maintaining, repairing and replacing signage for the Common Parts;
|
7.1.5
|
cleaning, maintaining, repairing, operating and replacing security machinery and equipment (including closed circuit television) on the Common Parts;
|
7.1.6
|
cleaning, maintaining, repairing, operating and replacing fire prevention, detection and fighting machinery and equipment and fire alarms on the Common Parts;
|
7.1.7
|
cleaning, maintaining, repairing and replacing a signboard showing the names and logos of the tenants and other occupiers in the entrance hall of the Building if any;
|
7.1.8
|
maintaining the landscaped and grassed areas of the Common Parts;
|
7.1.9
|
cleaning, maintaining, repairing and replacing the floor coverings on the internal areas of the Common Parts;
|
7.1.10
|
cleaning, maintaining, repairing and replacing the furniture and fittings on the Common Parts;
|
7.1.11
|
cleaning, maintaining, repairing and replacing the furniture, fittings and equipment in the lavatories on the Common Parts and providing hot and cold water, soap, paper, towels and other supplies for them;
|
7.1.12
|
heating the internal areas of the Building and cleaning, maintaining, repairing and replacing heating machinery and equipment serving the Building;
|
7.1.13
|
providing air-conditioning for the internal areas of the Common Parts and/or the Building and cleaning, maintaining, repairing and replacing air-conditioning equipment serving the Common Parts;
|
7.1.14
|
providing reception and cleaning staff for the Building and such reception staff shall co-ordinate the use of the boardroom and meetings rooms; and
|
7.1.15
|
any other service or amenity that the Landlord may in its absolute discretion provide for the benefit of the tenants and occupiers of the Building.
|
7.2
|
The "
Service Costs
" are the total of:
|
7.2.1
|
the whole of the proper costs properly incurred of:
|
7.2.1.1
|
providing the Services;
|
7.2.1.2
|
the supply and removal of electricity, gas, water, sewage and other utilities to and from the Building;
|
7.2.1.3
|
complying with the reasonable recommendations and the requirements of the insurers of the Building (insofar as those recommendations and requirements relate to the Common Parts);
|
7.2.1.4
|
complying with all laws relating to the Common Parts, their use and any works carried out at them, and relating to the use of all Service Media, machinery and equipment at or serving the Common Parts and to any materials kept at or disposed of from the Common Parts;
|
7.2.1.5
|
complying with the Third Party Rights insofar as they relate to the Common Parts; and
|
7.2.1.6
|
taking any steps (including proceedings) that the Landlord (acting reasonably) considers necessary to prevent or remove any encroachment over the Common Parts or to prevent the acquisition of any right over the Common Parts (or the Building as a whole) or to remove any obstruction to the flow of light or air to the Common Parts (or the Building as a whole);
|
7.2.2
|
the proper costs, fees and disbursements (on a full indemnity basis) of:
|
7.2.2.1
|
managing agents employed by the Landlord for the carrying out and provision of the Services or, where managing agents are not employed, a management fee for the same; and
|
7.2.2.2
|
accountants employed by the Landlord to prepare and audit the service charge accounts;
|
7.2.3
|
(insofar as they relate to the Building only) the costs of the salaries and employer costs (including pension, welfare and insurance contributions) of reception and cleaning staff for the Building and of all equipment and supplies needed for the proper performance of their duties;
|
7.2.4
|
all rates, taxes, impositions and outgoings payable in respect of the Common Parts, their use and any works carried out on them (other than any taxes payable by the Landlord in connection with any ownership or holding on trust of or dealing with or disposition of its reversionary interest in the Building); and
|
7.2.5
|
any VAT payable by the Landlord in respect of any of the items mentioned above except to the extent that the Landlord obtains credit for such VAT under the VATA 1994.
|
7.3
|
Subject to the Tenant paying the Service Charge, the Landlord shall use reasonable endeavours (where it is not the responsibility of the Tenant under this lease or save where any Service Media forms part of the Property):
|
7.3.1
|
to clean, maintain, decorate and repair the Common Parts, including the structural parts of the Building and all Service Media forming part of the Common Parts ;
|
7.3.2
|
to repair the Common Parts;
|
7.3.3
|
to provide heating and air-conditioning to the internal areas of the Common Parts and the Property during such periods of the year as the Landlord reasonably considers appropriate;
|
7.3.4
|
to provide electricity, gas and water to the Property;
|
7.3.5
|
to keep the internal areas of the Common Parts clean, and to clean the outside of the windows of the Building as often as the Landlord reasonably considers appropriate;
|
7.3.6
|
to keep the internal areas of the Common Parts reasonably well lit and in any event no worse lit than they are at the date of this Lease;
|
7.3.7
|
to supply hot and cold water, soap, paper, towels and other supplies for the lavatories in the Common Parts;
|
7.3.8
|
to clean, maintain, repair, operate and replace fire prevention, detection and fighting machinery and equipment and fire alarms on the Common Parts;
|
7.3.9
|
to heat the internal areas of the Building and clean, maintain, repair and replace heating machinery and equipment serving the Building; and
|
7.3.10
|
to provide air-conditioning for the internal areas of the Common Parts and clean, maintain, repair and replace air-conditioning equipment serving the Common Parts.
|
7.4
|
The Landlord may, but shall not be obliged to, provide any of the other Services. The Landlord shall not be obliged to carry out any works where the need for those works has arisen by reason of any damage or destruction by a risk against which the Landlord is not obliged to insure.
|
7.5
|
The Landlord shall not be liable for:
|
7.5.1
|
any interruption in, or disruption to, the provision of any of the Services for any reason that is outside the reasonable control of the Landlord provided that the Landlord has taken reasonably practicable steps to stop, limit or prevent any such interruption of disruption PROVIDED THAT this will not apply in relation to the failure of any utility providers; or
|
7.5.2
|
any injury, loss or damage suffered by the Tenant as a result of any absence or insufficiency of any of the Services or of any breakdown or defect in any Service Media, except where due to the negligence of the Landlord.
|
7.6
|
Before or as soon as practicable after the start of each Service Charge Year, the Landlord shall prepare and send the Tenant an estimate of the Service Costs for
|
7.7
|
The Tenant shall pay the estimated Service Charge for each Service Charge Year in four equal instalments on each of the Rent Payment Dates.
|
7.8
|
In relation to the Service Charge Year current at the date of this lease, the Tenant’s obligations to pay the estimated Service Charge and the actual Service Charge shall be limited to an apportioned part of those amounts, such apportioned part to be calculated on a daily basis for the period from and including the date of this lease to the end of the Service Charge Year. The estimated Service Charge for which the Tenant is liable shall be paid in equal instalments on the remaining Rent Payment Dates during the period from and including the date of this lease until the end of the Service Charge Year.
|
7.9
|
As soon as reasonably practicable after the end of each Service Charge Year, the Landlord shall prepare and send to the Tenant a certificate (prepared by an independent and properly qualified person) showing the Service Costs and the Service Charge for that Service Charge Year .For the period of one month from the date of receipt of the said certificate by the Tenant the Tenant shall be entitled to inspect ( at a location convenient to the Tenant ) all invoices receipts vouchers and any other relevant paperwork used to compile the Service Charge and to take copies thereof.
|
7.10
|
If any cost which should have been included in the calculation of the Service Charge in any Service Charge Year is omitted from it, the Landlord shall be entitled to include it in the estimate and certificate of the Service Charge in any following Service Charge Year. Otherwise, and except in the case of manifest or proven error, the Service Charge certificate shall be conclusive as to all matters of fact to which it refers.
|
7.11
|
If, in respect of any Service Charge Year, the Landlord’s estimate of the Service Charge is less than the Service Charge, the Tenant shall pay the difference on written demand. If, in respect of any Service Charge Year, the Landlord’s estimate of the Service Charge is more than the Service Charge, the Landlord shall credit the difference against the Tenant’s next instalment of the estimated Service Charge (and where the difference exceeds the next instalment then the balance of the
|
8
|
INSURANCE
|
8.1
|
Subject to
clause 8.2
, the Landlord shall keep the Building insured against loss or damage by the Insured Risks for the sum which the Landlord considers to be its full reinstatement cost (taking inflation of building costs into account). The Landlord shall not be obliged to insure any part of the Property installed by the Tenant.
|
8.2
|
The Landlord’s obligation to insure is subject to:
|
8.2.1
|
any exclusions, limitations, excesses and conditions that may be imposed by the insurers; and
|
8.2.2
|
insurance being available in the London insurance market on reasonable terms acceptable to the Landlord.
|
8.3
|
The Tenant shall pay to the Landlord on written demand:
|
8.3.1
|
the Insurance Rent;
|
8.3.2
|
any amount that is deducted or disallowed by the insurers pursuant to any excess provision in the insurance policy; and
|
8.3.3
|
the Tenant’s Proportion of any costs that the Landlord incurs in obtaining a valuation of the Building for insurance purposes.
|
8.4
|
The Tenant shall:
|
8.4.1
|
promptly inform the Landlord if any matter occurs in relation to the Tenant or the Property that any insurer or underwriter may treat as material in deciding whether or on what terms to insure or to continue to insure the Building;
|
8.4.2
|
not do or omit anything as a result of which any policy of insurance of the Building (of the terms of which the Tenant has notice) may become void or voidable or otherwise prejudiced, or the payment of any policy money may be withheld, nor (unless the Tenant has previously notified the Landlord and has paid any increased or additional premium) anything as a result of which any increased or additional insurance premium may become payable;
|
8.4.3
|
comply at all times with the requirements and reasonable recommendations of the insurers relating to the Property and the use by the Tenant of the Common Parts;
|
8.4.4
|
promptly give the Landlord notice of the occurrence of any damage or loss relating to the Property arising from an Insured Risk;
|
8.4.5
|
not effect any insurance of the Property, but if it becomes entitled to the benefit of any insurance proceeds in respect of the Property pay those proceeds or cause them to be paid to the Landlord; and
|
8.4.6
|
pay the Landlord an amount equal to any insurance money that the insurers of the Building refuse to pay (in relation to the Building) by reason of any act or omission of the Tenant or any undertenant, their workers, contractors or agents or any person at the Property or the Common Parts with the actual or implied authority of any of them.
|
8.5
|
The Landlord shall, subject to obtaining all necessary planning and other consents, use all insurance money received (other than for loss of rent) in connection with any damage to the Building to repair the damage for which the money has been received or (as the case may be) in rebuilding the Building. The Landlord shall not be obliged to:
|
8.5.1
|
provide accommodation or facilities identical in layout or design so long as accommodation reasonably equivalent to that previously at the Property and its access, services and amenities is provided; or
|
8.5.2
|
repair or rebuild if the Tenant has failed to pay any of the Insurance Rent; or
|
8.5.3
|
repair or rebuild the Building after a notice has been served pursuant to
clause 8.7
or
clause 8.8
.
|
8.6
|
If the Property is damaged or destroyed by an Insured Risk or Uninsured Risk so as to be unfit for occupation and use or if the Common Parts are damaged or destroyed by an Insured Risk or Uninsured Risk so as to make the Property inaccessible or unusable then, unless and to the extent the policy of insurance in relation to the Property or the Common Parts has been vitiated in whole or in part in consequence of any act or omission of the Tenant, any undertenant or their respective workers, contractors or agents or any other person on the Property or the Common Parts with the actual or implied authority of any of them, payment of the Annual Rent, or a fair proportion of it according to the nature and extent of the damage, shall be suspended until the Property has been reinstated and made fit for occupation and use or the Common Parts have been reinstated so as to make
|
8.7
|
If, following damage to or destruction of the Building, the Landlord considers that it is impossible or impractical to reinstate the Building or the Property has not been reinstated so as to be fit for occupation or the Common Parts have not been reinstated to make the Property accessible or useable within one year after the date of damage or destruction, the Landlord may terminate this lease by giving notice to the Tenant. On giving notice this lease shall determine but this shall be without prejudice to any right or remedy of the Landlord or the Tenant in respect of any breach of the tenant covenants of this lease. Any proceeds of the insurance shall belong to the Landlord.
|
8.8
|
Provided that the Tenant has complied with its obligations in this clause, the Tenant may terminate this lease by giving notice to the Landlord if, following damage or destruction of the Property or the Common Parts by an Insured Risk, the Property has not been reinstated so as to be fit for occupation and use or the Common Parts have not been reinstated so as to make the Property accessible or useable within one year after the date of damage or destruction. On giving this notice this lease shall determine but this shall be without prejudice to any right or remedy of the Landlord or the Tenant in respect of any breach of the covenants of this lease. Any proceeds of the insurance shall belong to the Landlord.
|
9
|
RATES AND TAXES
|
9.1
|
The Tenant shall pay all present and future rates, taxes and other impositions and outgoings payable in respect of the Property, its use and any works carried out there, except:
|
9.1.1
|
any taxes payable by the Landlord in connection with ownership or holding on trust of or any dealing with or disposition of the reversion to this lease; or
|
9.1.2
|
any taxes (other than VAT and insurance premium tax) payable by the Landlord by reason of the receipt of any of the rents due under this lease.
|
9.2
|
If any such rates, taxes or other impositions and outgoings are payable in respect of the Property together with other land (including any other part of the Building) the Tenant shall pay a fair proportion of the total.
|
9.3
|
The Tenant shall not make any proposal to alter the rateable value of the Property or that value as it appears on any draft rating list, without the approval of the Landlord.
|
9.4
|
If, after the end of the term, the Landlord loses rating relief (or any similar relief or exemption) because it has been allowed to the Tenant, then the Tenant shall pay the Landlord an amount equal to the relief or exemption that the Landlord has lost.
|
10
|
UTILITIES
|
10.1
|
The Tenant shall pay all costs in connection with the supply and removal of electricity, gas, water, sewage, telecommunications and data and other services and utilities to or from the Property.
|
10.2
|
The Tenant shall comply with all laws and with any reasonable recommendations of the relevant suppliers relating to the use of those services and utilities the supply and removal of electricity, gas, water, sewage, telecommunications, data and other services and utilities to or from the Property.
|
11
|
COMMON ITEMS
|
11.1
|
From time to time to pay on demand a fair proportion (to be determined by the Landlord acting reasonably) of the expenses payable in respect of repairing renewing cleansing and lighting as appropriate all ( if any) roofs walls fences Service Media drains roads paths pavements car parks and hard standings and other things the use or benefit of which is common to the Building and other premises insofar as such expense is not included in the annual service charge herein reserved
|
11.2
|
The Tenant shall comply with all reasonable regulations the Landlord may make and communicate to the Tenant from time to time in connection with the use of any of those Service Media, structures or other items.
|
12
|
VAT
|
12.1
|
All sums payable by the Tenant are exclusive of any VAT that may be chargeable. On receipt of a valid VAT invoice addressed to the Tenant the Tenant shall pay VAT in respect of all taxable supplies made to it in connection with this lease on the due date for making any payment.
|
12.2
|
Every obligation on the Tenant, under or in connection with this lease, to pay the Landlord or any other person any sum by way of a refund or indemnity, shall include an obligation to pay an amount equal to any VAT incurred on that sum by the
|
13
|
DEFAULT INTEREST AND INTEREST
|
13.1
|
If any Annual Rent has not been paid by the date it is due whether it has been formally demanded or not or if any other money due under the terms of this Lease has not been paid within 15 working days of the Tenant’s receipt of a written demand therefor, the Tenant shall pay the Landlord interest on that amount at the Default Interest Rate (both before and after any judgment). Such interest shall accrue on a daily basis for the period beginning on the due date to and including the date of payment.
|
13.2
|
If the Landlord does not demand or accept any Annual Rent or other money due or tendered under this lease because the Landlord reasonably believes that the Tenant is in breach of any of the tenant covenants of this lease, then the Tenant shall, when that amount is accepted by the Landlord, also pay interest at the Interest Rate on that amount for the period beginning on the date the amount (or each part of it) became due until the date it is accepted by the Landlord.
|
14
|
COSTS
|
14.1
|
The Tenant shall pay the proper costs and expenses of the Landlord including any solicitors’ or other professionals’ costs and expenses (incurred both during and after the end of the term) properly incurred in connection with or in bona fide contemplation of any of the following:
|
14.1.1
|
the enforcement of the tenant covenants of this lease;
|
14.1.2
|
serving any notice in connection with this lease under section 146 or 147 of the Law of Property Act 1925 or taking any proceedings under either of those sections, notwithstanding that forfeiture is avoided otherwise than by relief granted by the court;
|
14.1.3
|
serving any notice in connection with this lease under section 17 of the Landlord and Tenant (Covenants) Act 1995;
|
14.1.4
|
the preparation and service of a schedule of dilapidations in connection with this lease; or
|
14.1.5
|
any consent or approval applied for under this lease, whether or not it is granted unless such consent or approval has been unreasonably withheld or delayed.
|
14.2
|
Where the Tenant is obliged to pay or indemnify the Landlord against any solicitors’ or other professionals’ costs and expenses (whether under this or any other clause of this lease) that obligation extends to those costs and expenses assessed on a full indemnity basis.
|
15
|
COMPENSATION ON VACATING
|
16
|
SET-OFF
|
17
|
PROHIBITION OF DEALINGS
|
17.1
|
The Tenant shall not assign, underlet, charge ( other than by way of a bona fide charge at arms’ length to a recognised financial institution), part with or share possession of this lease or the Property or hold the lease on trust for any person.
|
17.1.1
|
Notwithstanding anything else contained in this Lease if the Tenant for the time being is a company the sharing of the use of the Property or any part thereof with another company within the same group of companies as defined in Section 42(1) of the 1954 Act (“Group Company”) shall be permitted provided that
|
17.1.1.1
|
no tenancy licence or other legal estate or interest nor any legally enforceable right of occupation shall thereby be created;
|
17.1.1.2
|
no relationship of landlord and tenant is established by the arrangement;
|
17.1.1.3
|
such use shall only continue so long as such other company shall remain a member of the same group as the Tenant
|
18
|
REPAIRS
|
18.1
|
The Tenant shall keep the Property clean and tidy and in good repair and condition and shall ensure that any Service Media within and exclusively serving the Property is kept in good working order PROVIDED THAT (and notwithstanding anything else contained in this Lease) the Tenant shall not be obliged to keep the Property in a better state of repair and condition than as evidenced by the Schedule of Condition.
|
18.2
|
The Tenant shall not be liable to repair the Property to the extent that any disrepair has been caused by an Insured Risk, unless and to the extent that:
|
18.2.1
|
the policy of insurance of the Property has been vitiated or any insurance proceeds withheld in consequence of any act or omission of the Tenant, any undertenant or their respective workers, contractors or agents or any person on the Property with the actual or implied authority of any of them; or
|
18.2.2
|
the insurance cover in relation to that disrepair is excluded, limited, is unavailable or has not been extended, as mentioned in
clause 8.2
.
|
19
|
DECORATION
|
19.1
|
The Tenant shall decorate the Property as often as is reasonably necessary and in the last three months before the end of the term.
|
19.2
|
All decoration shall be carried out in a good and proper manner using good quality materials that are appropriate to the Property and the Permitted Use and shall include all appropriate preparatory work.
|
19.3
|
All decoration carried out in the last three months of the term shall also be carried out to the reasonable satisfaction of the Landlord and using materials, designs and colours approved by the Landlord such approval not to be reasonably withheld.
|
19.4
|
The Tenant shall replace the floor coverings ( by which is meant carpet or carpet tiles wherever they are present) at the Property within three months before the end of the term with new ones of good quality and appropriate to the Property and the Permitted Use.
|
20
|
ALTERATIONS AND SIGNS
|
20.1
|
The Tenant shall not make any structural alterations to the Property.
|
20.2
|
The Tenant shall not make any internal alterations to the Property without the consent of the Landlord, such consent not to be unreasonably withheld.
|
20.3
|
The Tenant shall not install nor alter the route of any Service Media at the Property without the consent of the Landlord, such consent not to be unreasonably withheld.
|
20.4
|
The Tenant shall not attach any sign, fascia, placard, board, poster or advertisement to the Property so as to be seen from the outside of the Building.
|
20.5
|
The Tenant shall not carry out any alteration to the Property which would, or may reasonably be expected to, have an adverse effect on the asset rating in any Energy Performance Certificate commissioned in respect of the Property.
|
21
|
RETURNING THE PROPERTY TO THE LANDLORD
|
21.1
|
At the end of the term the Tenant shall return the Property to the Landlord in the repair and condition required by this lease.
|
21.2
|
No later than three months before the end of the term, the Tenant shall remove items it has fixed to the Property, remove any alterations it has made to the Property and make good any damage caused to the Property by that removal.
|
21.3
|
At the end of the term, the Tenant shall remove from the Property all chattels belonging to or used by it.
|
21.4
|
The Tenant irrevocably appoints the Landlord to be the Tenant’s agent to store or dispose of any chattels or items it has fixed to the Property and which have been left by the Tenant on the Property for more than ten working days after the end of the term. The Landlord shall not be liable to the Tenant by reason of that storage or disposal. The Tenant shall indemnify the Landlord in respect of any claim made by a third party in relation to that storage or disposal.
|
22
|
USE
|
22.1
|
The Tenant shall not use the Property for any purpose other than the Permitted Use.
|
22.2
|
The Tenant shall not use the Property for any illegal purpose nor for any purpose or in a manner that would cause loss, damage, injury, nuisance or inconvenience to the Landlord, the other tenants or occupiers of the Lettable Units or any owner or occupier of neighbouring property.
|
22.3
|
The Tenant shall not overload any structural part of the Building nor any Service Media at or serving the Property.
|
23
|
MANAGEMENT OF THE BUILDING
|
23.1
|
The Tenant shall observe all regulations made by the Landlord from time to time in accordance with the principles of good estate management and notified to the Tenant relating to the use of the Common Parts and the management of the Building.
|
23.2
|
Nothing in this lease shall impose or be deemed to impose any restriction on the use of any other Lettable Unit or any neighbouring property.
|
24
|
COMPLIANCE WITH LAWS
|
24.1
|
The Tenant shall comply with all laws relating to:
|
24.1.1
|
the Property and the occupation and use of the Property by the Tenant;
|
24.1.2
|
the use or operation of all Service Media and machinery and equipment at or serving the Property whether or not used or operated, and shall, where necessary, replace or convert such Service Media exclusively serving the Property so that it is capable of lawful use or operation;
|
24.1.3
|
any works carried out at the Property; and
|
24.1.4
|
all materials kept at or disposed from the Property.
|
24.2
|
Without prejudice to any obligation on the Tenant to obtain any consent or approval under this lease, the Tenant shall carry out all works that are required under any law to be carried out at the Property whether by the owner or the occupier.
|
24.3
|
Within five working days after receipt of any notice or other communication affecting the Property or the Building (and whether or not served pursuant to any law) the Tenant shall:
|
24.3.1
|
send a copy of the relevant document to the Landlord; and
|
24.3.2
|
insofar as it relates to the Property, take all steps necessary to comply with the notice or other communication and take any other action in connection with it as the Landlord may require at the joint cost of the Landlord and the Tenant.
|
24.4
|
The Tenant shall not apply for any planning permission for the Property.
|
24.5
|
The Tenant shall comply with its obligations under the CDM Regulations, including all requirements in relation to the provision and maintenance of a health and safety file.
|
24.6
|
The Tenant shall supply all information to the Landlord that the Landlord reasonably requires from time to time to comply with the Landlord’s obligations under the CDM Regulations.
|
24.7
|
As soon as the Tenant becomes aware of any defect in the Property, it shall give the Landlord notice of it. The Tenant shall indemnify the Landlord against any liability
|
24.8
|
The Tenant shall keep the Property equipped with all fire prevention, detection and fighting machinery and equipment and fire alarms which are required under all relevant laws or required by the insurers of the Property or reasonably recommended by them or reasonably required by the Landlord and shall keep that machinery, equipment and alarms properly maintained and available for inspection.
|
25
|
ENERGY PERFORMANCE CERTIFICATES
|
25.1
|
The Tenant shall:
|
25.1.1
|
co-operate with the Landlord so far as is reasonably necessary to allow the Landlord to obtain an Energy Performance Certificate and Recommendation Report for the Property or the Building including providing the Landlord with copies of any plans or other information held by the Tenant that would assist in obtaining an Energy Performance Certificate; and
|
25.1.2
|
allow such access to any Energy Assessor appointed by the Landlord as is reasonably necessary to inspect the Property for the purposes of preparing an Energy Performance Certificate and/or Recommendation Report for the Property or the Building.
|
25.2
|
The Tenant shall not commission an Energy Performance Certificate for the Property without the Landlord's consent.
|
26
|
ENCROACHMENTS, OBSTRUCTIONS AND ACQUISITION OF RIGHTS
|
26.1
|
The Tenant shall not grant any right or licence over the Property to a third party.
|
26.2
|
If a third party makes or attempts to make any encroachment over the Property or takes any action by which a right may be acquired over the Property, the Tenant shall:
|
26.2.1
|
promptly inform the Landlord and shall give the Landlord notice of that encroachment or action; and
|
26.2.2
|
take all steps (including any proceedings) the Landlord reasonably requires to prevent or license the continuation of that encroachment or action but at the joint cost of the Landlord and the Tenant.
|
26.3
|
The Tenant shall not obstruct the flow of light or air to the Property or any other part of the Building nor obstruct any means of access to the Property or any other part of the Building.
|
26.4
|
The Tenant shall not make any acknowledgement that the flow of light or air to the Property or any other part of the Building or that the means of access to the Property or any other part of the Building is enjoyed with the consent of any third party.
|
26.5
|
If any person takes or threatens to take any action to obstruct the flow of light or air to the Property or obstruct the means of access to the Property, the Tenant shall:
|
26.5.1
|
promptly inform the Landlord; and
|
26.5.2
|
take all steps (including proceedings) the Landlord reasonably requires to prevent or secure the removal of the obstruction but at the joint cost of the Landlord and the Tenant.
|
27
|
BREACH OF REPAIR AND MAINTENANCE OBLIGATIONS
|
27.1
|
The Landlord may enter the Property on giving reasonable written notice to inspect its condition and state of repair and may give the Tenant a notice of any breach of any of the tenant covenants in this lease relating to the condition or repair of the Property.
|
27.2
|
If the Tenant has not begun any works needed to remedy that breach within two months following that notice (or if works are required as a matter of emergency, then as soon as reasonably practicable) or if the Tenant is not carrying out the works with all due speed, then the Landlord may enter the Property and carry out the works needed.
|
27.3
|
The proper costs properly incurred by the Landlord in carrying out any works pursuant to this clause (and any professional fees and any VAT in respect of those costs) shall be a debt due from the Tenant to the Landlord and payable on written demand.
|
27.4
|
Any action taken by the Landlord pursuant to this clause shall be without prejudice to the Landlord’s other rights, including those under
clause 30
.
|
28
|
INDEMNITY
|
28.1
|
The Tenant shall keep the Landlord indemnified against all liabilities, expenses, costs (including but not limited to any solicitors' or other professionals' costs and expenses), claims, damages and losses (including but not limited to any diminution
|
28.2
|
The Landlord shall keep the Tenant indemnified against all liabilities expenses, costs (including but not limited to any solicitors' or other professionals' costs and expenses), claims, damages and losses suffered or incurred by the Tenant in connection with or arising out of Environmental Law which are the responsibility of the Landlord in accordance with clause 38 only.
|
28.3
|
All indemnities given under this Lease shall be subject to the condition that the parties hereto shall jointly negotiate and deal with any claims against the other and any actions and proceedings resulting therefrom in close consultation with one another and that neither party will settle or compromise any such claim without the prior written consent of the other party (such consent not to be unreasonably withheld or delayed) subject to the rights and powers of any insurers
|
29
|
LANDLORD'S COVENANT FOR QUIET ENJOYMENT
|
30
|
RE-ENTRY AND FORFEITURE
|
30.1
|
The Landlord may re-enter the Property (or any part of the Property in the name of the whole) at any time after any of the following occurs:
|
30.1.1
|
any rent is unpaid 21 days after becoming payable whether it has been formally demanded or not;
|
30.1.2
|
any breach of any condition of, or tenant covenant in, this lease;
|
30.1.3
|
an Act of Insolvency.
|
30.2
|
If the Landlord re-enters the Property (or any part of the Property in the name of the whole) pursuant to this clause, this lease shall immediately end, but without prejudice to any right or remedy of the Landlord in respect of any breach of covenant by the Tenant or any guarantor.
|
31
|
JOINT AND SEVERAL LIABILITY
|
31.1
|
Where the Tenant comprises more than one person, those persons shall be jointly and severally liable for the obligations and liabilities of the Tenant arising under this lease. The Landlord may take action against, or release or compromise the liability of, or grant time or other indulgence to, any one of those persons without affecting the liability of any other of them.
|
31.2
|
Where a guarantor comprises more than one person, those persons shall be jointly and severally liable for the obligations and liabilities of a guarantor arising under this lease. The Landlord may take action against, or release or compromise the liability of, or grant time or other indulgence to, any one of those persons without affecting the liability of any other of them.
|
31.3
|
The obligations of the Tenant and any guarantor arising by virtue of this lease are owed to the Landlord and the obligations of the Landlord are owed to the Tenant.
|
31.4
|
The Landlord shall not be liable to the Tenant for any failure of the Landlord to perform any landlord covenant in this lease unless and until the Tenant has given the Landlord notice of the failure and the Landlord has not remedied the failure within a reasonable time of service of that notice.
|
32
|
ENTIRE AGREEMENT
|
32.1
|
This lease constitutes the whole agreement between the parties and supersedes all previous discussions, correspondence, negotiations, arrangements, understandings and agreements between them relating to its subject matter.
|
32.2
|
Nothing in this lease constitutes or shall constitute a representation or warranty that the Property may lawfully be used for any purpose allowed by this lease.
|
33
|
NOTICES, CONSENTS AND APPROVALS
|
33.1
|
Except where this lease specifically states that a notice need not be in writing, any notice given under or in connection with this lease shall be:
|
33.1.1
|
in writing and for the purposes of this clause an email is not in writing; and
|
33.1.2
|
given:
|
33.1.2.1
|
by hand or by pre-paid first-class post or other next working day delivery service at the party's registered office address (if the party is a company) or (in any other case) at the party's principal place of business.
|
33.2
|
If a notice complies with the criteria in
clause 33.1
, whether or not this lease requires that notice to be in writing, it shall be deemed to have been received:
|
33.2.1
|
if delivered by hand, at the time the notice is left at the proper address;
|
33.2.2
|
if sent by pre-paid first-class post or other next working day delivery service, on the second working day after posting; or
|
33.3
|
This clause does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution.
|
33.4
|
Section 196 of the Law of Property Act 1925 shall otherwise apply to notices given under this lease.
|
33.5
|
Where the consent of the Landlord is required under this lease, a consent shall only be valid if it is given by deed, unless:
|
33.5.1
|
it is given in writing and signed by the Landlord or a person duly authorised on its behalf; and
|
33.5.2
|
it expressly states that the Landlord waives the requirement for a deed in that particular case.
|
33.6
|
Where the approval of the Landlord is required under this lease, an approval shall only be valid if it is in writing and signed by or on behalf of the Landlord, unless:
|
33.6.1
|
the approval is being given in a case of emergency; or
|
33.6.2
|
this lease expressly states that the approval need not be in writing.
|
33.7
|
If the Landlord gives a consent or approval under this lease, the giving of that consent or approval shall not imply that any consent or approval required from a third party has been obtained, nor shall it obviate the need to obtain any consent or approval from a third party.
|
34
|
GOVERNING LAW
|
35
|
JURISDICTION
|
36
|
EXCLUSION OF SECTIONS 24-28 OF THE LTA 1954
|
36.1
|
The parties confirm that:
|
36.1.1
|
the Landlord served a notice on the Tenant, as required by section 38A(3)(a) of the LTA 1954, applying to the tenancy created by this lease, before this lease was entered into;
|
36.1.2
|
Mary Sargent who was duly authorised by the Tenant to do so made a statutory declaration dated 22 December, 2017 in accordance with the requirements of section 38A(3)(b) of the LTA 1954; and
|
36.1.3
|
there is no agreement for lease to which this lease gives effect.
|
36.2
|
The parties agree that the provisions of sections 24 to 28 of the LTA 1954 are excluded in relation to the tenancy created by this lease.
|
37
|
CONTRACTS (RIGHTS OF THIRD PARTIES) ACT 1999
|
38
|
AGREEMENT ON ENVIRONMENTAL LIABILITIES
|
38.1
|
Any liability under Environmental Law (including, without limitation, any liability under the Contaminated Land Regime) arising in respect of Hazardous Substances in, on, under or emanating from the Property, on or before the date of this Lease, shall be the sole responsibility of the Landlord.
Save in relation to the management
|
38.2
|
This clause 38 constitutes an agreement on liabilities under the Department for Environment, Food and Rural Affairs' statutory guidance on the Contaminated Land Regime.
|
38.3
|
If the Enforcing Authority serves a notice under the Contaminated Land Regime on either party, either party may produce a copy of this Clause 38 to any Enforcing Authority or court for the purposes of determining liability under the Contaminated Land Regime, regardless of any confidentiality agreement that may exist between the parties relating to this Lease or any of its provisions.
|
38.4
|
Neither party shall challenge the application of the agreement on liabilities set out in this clause.
|
39
|
TENANT’S BREAK RIGHT
|
39.1
|
In this clause the following definitions apply:
|
39.2
|
Subject to clause 39.3, the Tenant may terminate this lease by serving a Break Notice on the Landlord at least six months before the Break Date.
|
39.3
|
The Break Notice shall have no effect if at the Break Date:
|
39.3.1
|
the Tenant has not paid any part of the Annual Rent, or any VAT in respect of it, which was due to have been paid; or
|
39.3.2
|
the whole of the Property is not given back to the Landlord at the end of the term free of any third party occupational rights and free of the occupational right of the Tenant.
|
39.4
|
The Break Notice shall be in writing and, for the purposes of this clause, writing does not include facsimile transmission or email.
|
39.5
|
The Break Notice shall not purport to terminate the Lease in relation to any part as opposed to the whole of the Property.
|
39.6
|
The Break Notice shall be signed by the Tenant or by a person who is expressed to sign on behalf of and with the authority of the Tenant.
|
39.7
|
The Break Notice shall be served by delivering it by hand or sending it by pre-paid first-class post or recorded delivery to the Landlord at The Merrifield Centre, Rosemary Lane, Cambridge CB1 3LQ.
|
39.8
|
In proving service of the Break Notice it shall be sufficient to prove that delivery by hand was made or that the envelope containing the Break Notice was correctly addressed and posted by pre-paid first-class post or recorded delivery, as the case may be.
|
39.9
|
A Break Notice delivered or sent by the Tenant in accordance with clause 39.8 shall be deemed to have been served on the Landlord:
|
39.9.1
|
if delivered by hand, on the day of delivery, except that if delivery occurs after noon on a Working Day or on a day that is not a Working Day, then the notice shall be deemed to have been served on the next Working Day;
|
39.9.2
|
if sent by pre-paid first-class post or recorded delivery, on the second Working Day after posting (for the avoidance of doubt, not including the date of posting itself).
|
39.10
|
The Break Notice shall be delivered or sent by the Tenant so that it shall be deemed to have been served on the Landlord as provided by clause 39.9 not less than six months before the Break Date stated in the Break Notice (and for the avoidance of doubt, the day of deemed receipt shall not be taken into account in calculating the period of six months).
|
39.11
|
Neither section 196 of the Law of Property Act 1925, nor section 1139 of the Companies Act 2006 shall apply to a Break Notice, but those sections shall apply to any other notice served pursuant to this clause.
|
39.12
|
Time shall be of the essence in respect of all time periods and limits in this clause.
|
39.13
|
Subject to clause 39.3, following service of the Break Notice, this Lease shall terminate on the Break Date specified in the Break Notice.
|
39.14
|
Termination of this Lease pursuant to this clause shall be without prejudice to any right or remedy of either party in respect of any antecedent breach of the covenants or conditions in this Lease.
|
39.15
|
If this Lease terminates in accordance with clause 39.14 then, within 14 days of the Break Date, the Landlord shall refund to the Tenant the proportion of the Annual Rent and any other moneys paid in advance under the Lease, and any VAT paid in respect of it, for the period from and excluding the Break Date up to and excluding
|
40
|
LANDLORD’S BREAK RIGHT
|
40.1
|
In this clause the following definitions apply:
|
40.2
|
Subject to clause 40.3, the Landlord may terminate this lease by serving a Break Notice on the Tenant at least nine months before the Break Date.
|
40.3
|
The Break Notice shall have no effect if at the Break Date:
|
40.3.1
|
the Break Notice does not comply with the terms of this clause; or
|
40.3.2
|
the Break Notice is served otherwise in accordance with this clause.
|
40.4
|
The Break Notice shall be in writing and, for the purposes of this clause, writing does not include facsimile transmission or email.
|
40.5
|
The Break Notice shall not purport to terminate the Lease in relation to any part as opposed to the whole of the Property.
|
40.6
|
The Break Notice shall be signed by the Landlord or by a person who is expressed to sign on behalf of and with the authority of the Landlord.
|
40.7
|
The Break Notice shall be served by delivering it by hand or sending it by pre-paid first-class post or recorded delivery to the Tenant at The Merrifield Centre, Rosemary Lane, Cambridge CB1 3LQ.
|
40.8
|
In proving service of the Break Notice it shall be sufficient to prove that delivery by hand was made or that the envelope containing the Break Notice was correctly addressed and posted by pre-paid first-class post or recorded delivery, as the case may be.
|
40.9
|
A Break Notice delivered or sent by the Landlord in accordance with clause 40.8 shall be deemed to have been served on the Tenant:
|
40.9.1
|
if delivered by hand, on the day of delivery, except that if delivery occurs after noon on a Working Day or on a day that is not a Working Day, then the notice shall be deemed to have been served on the next Working Day;
|
40.9.2
|
if sent by pre-paid first-class post or recorded delivery, on the second Working Day after posting (for the avoidance of doubt, not including the date of posting itself).
|
40.10
|
The Break Notice shall be delivered or sent by the Landlord so that it shall be deemed to have been served on the Tenant as provided by clause 40.9 not less than nine months before the Break Date stated in the Break Notice (and for the avoidance of doubt, the day of deemed receipt shall not be taken into account in calculating the period of nine months).
|
40.11
|
Neither section 196 of the Law of Property Act 1925, nor section 1139 of the Companies Act 2006 shall apply to a Break Notice, but those sections shall apply to any other notice served pursuant to this clause.
|
40.12
|
Time shall be of the essence in respect of all time periods and limits in this clause.
|
40.13
|
Subject to clause 40.3, following service of the Break Notice, this Lease shall terminate on the Break Date specified in the Break Notice.
|
40.14
|
Termination of this Lease pursuant to this clause shall be without prejudice to any right or remedy of either party in respect of any antecedent breach of the covenants or conditions in this Lease.
|
40.15
|
If this Lease terminates in accordance with clause 40.14 then, within 14 days of the Break Date, the Landlord shall refund to the Tenant the proportion of the Annual Rent and any other moneys paid in advance under the Lease, and any VAT paid in respect of it, for the period from and excluding the Break Date up to and excluding the next Rent Payment Date ( in the case of the Annual Rent ), or the end of the period in respect of which the moneys have been paid in advance ( in respect of other payments ),calculated on a daily basis.
|
“Independent Measurers”
|
means such reputable measuring surveyors as the Landlord may choose to appoint.
|
“Schedule”
|
means the revised schedule of condition as referred to at clause 1.1.31.
|
1.
|
LANDLORD’S WORKS
|
1.1
|
The Landlord and Tenant acknowledge that the Landlord’s Works may be needed to the Property.
|
1.2
|
The Landlord and the Tenant will attempt to agree (acting reasonably) as soon as reasonably practicable following the date hereof on what, if anything, constitutes the Landlord’s Works and once agreement has been reached and on the basis of the
|
1.3
|
If the Landlord and the Tenant cannot so agree in accordance with paragraph 1.2 then any issues of disagreement will be referred to an expert for a decision in accordance with paragraph 4.
|
1.4
|
If and to the extent the Expert decides that Landlord’s Works are necessary then the Landlord will promptly carry out the Landlord’s Works (at the joint cost of the parties).
|
2.
|
CALCULATION OF ANNUAL RENT
|
2.1
|
The Landlord and Tenant agree and acknowledge that the Annual Rent in the Lease has been calculated as follows:
|
2.1.1
|
7,246 square feet at £25 per square foot (“Rate”) in respect of the area to be exclusively occupied by the Tenant;
|
2.1.2
|
1,829 square feet at £12.50 per square foot (“Rate”) in respect of the common areas ( the “ common areas”) in the Building ( shown shaded blue on Plan 1)
|
2.2
|
Promptly following the completion of the Landlord’s Works the Landlord will engage the Independent Measurers at the joint cost of the Landlord and Tenant to measure the Property and the common areas.
|
2.3
|
The Landlord will procure that the Independent Measurers issue the Duty of Care Letter to the Tenant promptly after completion of the measurement of the Property and the common areas by the Independent Measurers at the joint cost of the Landlord and Tenant.
|
2.4
|
If the product of the Independent Measurers’ measured floor area of the Property and the common areas (after completion of the Works) and the appropriate Rate is:
|
2.4.1
|
equal to or less than the figure for the Annual Rent which appears in the Lease the Landlord will prepare a memorandum acknowledging that fact (in a form to be approved by the Tenant acting reasonably) and both the Landlord and the Tenant will sign and exchange one copy of the memorandum and attach it to the Lease and Counterpart and from thenceforward the Annual Rent shall be the figure in the said memorandum;
|
2.4.2
|
greater by 2.5% than the figure for the Annual Rent which appears in the Lease the Landlord will prepare a memorandum acknowledging that fact (in a form to be approved by the Tenant acting reasonably) and both the Landlord and the Tenant will sign and exchange one copy of the memorandum and attach it to the Lease and Counterpart and from thenceforward the Annual Rent shall be the figure in the said memorandum.
|
2.5
|
In the circumstances envisaged by paragraph 2.4.1 the Landlord will promptly refund to the Tenant any Annual Rent which has been overpaid by the Tenant since the commencement of the Lease.
|
2.6
|
In the circumstances envisaged by paragraph 2.4.2 the Tenant will promptly pay to the Landlord the balance of any Annual Rent which has been underpaid by the Tenant since the commencement of the Lease.
|
3.
|
SCHEDULE OF CONDITION
|
3.1
|
Promptly on completion of the Landlord’s Works in accordance with paragraph 1, the Landlord will commission the Schedule at the joint cost of the Landlord and Tenant. If the Landlord and the Tenant cannot agree on the Schedule then the issue will be referred to an expert for a decision in accordance with paragraph 4 and the Landlord and the Tenant agree that (if the surveyor will accept the appointment) the identity of the said expert shall be the same as that of any Expert appointed under paragraph 4.
|
3.2
|
On receipt of the Expert’s decision as to the Schedule, the Landlord will complete the Schedule promptly and in any event within one month from the date of the Expert’s decision on the Schedule and the Landlord and the Tenant will each sign and then exchange one copy of the Schedule by way of confirmation that it is the Schedule referred to in the Lease.
|
4.
|
EXPERT DETERMINATION
|
4.1
|
In this paragraph 4 of Schedule 1, where any issue is required to be dealt with by, or submitted for the determination of, an independent expert, the following provisions of this paragraph 4 are to apply and in case of conflict with other provisions specifically relating to expert determination elsewhere in this Lease the provisions in this Schedule 1 are to prevail to the extent of the conflict.
|
4.2
|
In this paragraph 4 the Landlord and the Tenant are referred together as the “parties”
|
4.3
|
The expert is to be appointed by the parties jointly (acting reasonably), or if they cannot or do not agree on the appointment, appointed by whichever of the following is appropriate on application by either party:
|
4.3.1
|
the president from time to time of the Royal Institution of Chartered Surveyors; or
|
4.3.2
|
the president from time to time of the Institute of Chartered Accountants in England and Wales,
|
4.4
|
or in either case the duly appointed deputy of the president, or other person authorised by him to make appointments on his behalf.
|
4.5
|
The person so appointed is to
|
4.5.1
|
act as an expert, and not as an arbitrator; and
|
4.5.2
|
must afford the parties the opportunity within such a reasonable time limit as he may stipulate to make representations to him (accompanied by professional rental valuations, reports or other appropriate evidence in the relevant circumstances) and permit each party to make submissions on the representations of the other.
|
4.6
|
Neither party may without the consent of the other disclose to the expert correspondence or other evidence to which the privilege of non-production (“without prejudice”) properly attaches.
|
4.7
|
The fees and expenses of the expert, including the cost of his nomination, are to be borne as the expert may direct (but in the absence of such a direction, by the parties in equal shares), but (unless they otherwise agree) the parties shall bear their own costs with respect to the determination of the issue by the expert.
|
4.8
|
One party may pay the costs required to be borne by another party if they remain unpaid for more than 15 Working Days after they become due and then recover these and any incidental expenses incurred from the other party on demand.
|
4.9
|
If the expert refuses to act, becomes incapable of acting or dies, either party may request the appointment of another expert in his stead under paragraph 4.3.
|
4.10
|
The determination of the independent expert, except in case of manifest error, is to be binding on the parties.
|
Executed as a deed by
MERRIFIELD CENTRE LTD
acting by a director, in the presence of:
Witness signature:
Witness name:
Witness Address:
Witness occupation:
|
../s/ David Williams
…….………….
/s/ Sarah Fordham………………..
…Sarah Fordham………………..
……………………………………….
……………………………………….
……………………………………….
…Office Manager…………..……...
|
|
|
|
|
Executed as a deed by
DISCUVA LIMITED
acting by
a director, in the presence of:
Witness signature:
Witness name:
Witness Address:
Witness occupation:
|
…/s/ Ernesto Reggiani
.………….
/s/ Sarah Fordham…………….…..
Sarah Fordham….…… …………..
……………………………………….
……………………………………….
……………………………………….
Officer Manager…….……………...
|
|
EQUITY AND REVENUE SHARING AGREEMENT
(Seeding Drug Discovery Initiative and Translation Award) |
(1)
|
THE WELLCOME TRUST LIMITED
, a company registered in England & Wales with company no. 2711000 with registered address at 215 Euston Rd London NW1 2BE UK, as Trustee of the Wellcome Trust, a charity registered in England under no. 210183 (the
“Trust”
); and
|
(2)
|
SUMMIT (OXFORD) LIMITED
, a limited company registered in England and Wales under number 04636431 whose registered office is at 136A Eastern Avenue, Milton Park, Abingdon, Oxfordshire OX14 4SB (the
“Company”
).
|
(A)
|
Pursuant to a funding agreement between the Trust and the Company's holding company, Summit Therapeutics PLC (formerly Summit Corporation PLC and hereinafter
"Summit")
dated 30 October 2009, the Trust made a programme-related investment by way of an award of two million, two hundred and eighty eight thousand, two hundred and twenty one pounds sterling (£2,288,221) to Summit to progress the development of a novel class of antibiotics for the targeted treatment of
Clostridium difficile
infection in consideration of a share of any resulting revenue (the “
SDD Award
”).
|
(B)
|
The Trust made a Translation Award (award no. 099444/Z/12/Z) to Summit to support a first-in-human Phase I and Phase II clinical trial for the novel
Clostridium difficile
antibiotic SMT19969 (subsequently given the International Non-proprietary Name “ridinilazole”) in consideration of a share of any resulting revenue (the “
TA Award
”).
|
(C)
|
The Company is the wholly owned trading subsidiary of Summit and the entity that will be Exploiting the Exploitation IPRs (as defined in the TA Funding Agreement dated 19 October 2012). Summit has assigned the benefit and burden of the TA Funding Agreement (as defined below) to the Company and the Company acknowledges to the Trust that it is bound by the terms of the TA Funding Agreement.
|
(D)
|
To facilitate management and commercialisation of the technology arising under the SDD Award and the TA Award, the Parties have agreed that the Exploitation IPRs shall be exploited in accordance with the terms of this Agreement.
|
1.1
|
Capitalised terms in this Agreement shall be interpreted in accordance with the definitions as set out in the TA Funding Agreement or above. For ease, important definitions from the TA Funding Agreement are set forth in Schedule 3 Where a capitalised term is defined in both this Agreement and the TA Funding Agreement, the definition in this Agreement shall apply.
|
1.2
|
In this Agreement, unless the context otherwise requires:
|
1.3
|
“
Accounting Standard
”
|
means IFRS (International Financial Reporting Standards) as generally and consistently applied throughout each Party’s organisation;
|
1.4
|
"
BARDA
"
|
means the Biomedical Advanced Research and Development Authority;
|
1.5
|
“Effective Date
”
|
means 16 October, 2017;
|
1.6
|
“Exploitation Terms”
|
means the terms for the exploitation of the Exploitation IPR as set out in Schedule 1 to this Agreement;
|
1.7
|
"
First Commercial Sale
"
|
means, with respect to RDZ in a country, the first sale for end use or consumption of RDZ in such country after all regulatory approvals legally required for such sale have been granted by the regulatory authority of such country;
|
1.8
|
"
Pre-Commercial Payments
"
|
means all cumulative Net Revenue, which for clarity excludes any grant funding or any development funding received by the Company from a Third Party licensee (or sub-licensee) prior to the First Commercial Sale of RDZ
|
1.9
|
"
Quarterly Statement
"
|
has the meaning set out in Clause 4.1;
|
1.10
|
“
RDZ
”
|
means ridinilazole (SMT19969);
|
1.11
|
“
SDD Award
”
|
has the meaning set out in Recital (A);
|
1.12
|
“
TA Funding Agreement
”
|
means the Translation Award Funding Agreement between the Parties dated 19 October 2012; and
|
1.13
|
“
TA Award
”
|
has the meaning set out in Recital (B).
|
1.14
|
References in this Agreement to any statutory provisions shall be construed as references to those provisions as respectively amended consolidated or re‑enacted (whether before or after the Effective Date) from time to time and shall include any provisions of which they are consolidations or re-enactments (whether with or without amendment).
|
1.15
|
The Schedules and Recitals form part of this Agreement and any reference to this Agreement shall include the Schedules and Recitals.
|
1.16
|
In this Agreement:
|
(a)
|
the masculine gender shall include the feminine and neuter and the singular number shall include the plural and vice versa;
|
(b)
|
references to persons shall include bodies corporate, unincorporated associations, partnerships and individuals; and
|
(c)
|
except where the contrary is stated, any reference in this Agreement to a Clause or Schedule is to a Clause of or Schedule to this Agreement, and any reference within a Clause or Schedule to a sub‑Clause, paragraph or other sub-division is a reference to such sub‑Clause, paragraph or other sub-division so numbered or lettered in that Clause or Schedule.
|
1.17
|
The headings in this Agreement are inserted for convenience only and shall not affect the construction of the provision to which they relate.
|
1.18
|
References to the winding-up of a person include a company administration, dissolution, liquidation, bankruptcy, of such person and an equivalent or analogous procedure under the law of any jurisdiction in which that person is incorporated, domiciled or resident or carries on business or has assets.
|
1.19
|
Any reference to books, records or other information includes books, records or other information in any format or medium including paper, electronically stored data, video or audio recordings and microfilm.
|
1.20
|
Any phrase introduced by the terms “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.
|
1.21
|
Reference to any statute, statutory instrument, regulation, by law or other requirement of English law and to any English legal term for any actions, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or doctrine shall, in respect of any jurisdiction other than England, be deemed to include that which most nearly approximates in that jurisdiction to the relevant English term.
|
2.1
|
The Trust and the Company shall share cumulative Net Revenue received in respect of Exploitation of the Exploitation IPRs in accordance with the Exploitation Terms. The Parties agree that the Exploitation IPRs are those pertaining to RDZ and that RDZ is the Project Compound and the Licensed Product as defined in the TA Funding Agreement.
|
2.2
|
The Parties further agree that any development funding or grant funding received from BARDA or other Third Parties, including licensees, shall not be classed as Revenue.
|
2.3
|
For the avoidance of doubt, the Company's obligation to share cumulative Net Revenue received from Third Parties prior to the First Commercial Sale of RDZ shall be expressly limited to a one-time milestone payment as set out in Schedule 1 payable only following the First Commercial Sale of RDZ.
|
2.4
|
In the event that the Company receives any equity as part payment for a licence granted where a Third Party commercialises RDZ, then the Parties will discuss in good faith to determine an equitable share of such equity or a cash equivalent for the Trust.
|
2.5
|
In the event of a sale or assignment by the Company to a Third Party of the Exploitation IPR and/or the assets pertaining to RDZ, the Trust shall be entitled to its share of the net proceeds of such sale received by the Company as Net Revenue (including any deferred consideration or ongoing revenue stream to the Company in respect of the Exploitation IPR or assets pertaining to RDZ) and thereafter this Agreement shall terminate so that the share of Net Revenue set forth in Schedule 1 is not payable to the Trust by the acquiring Third Party.
|
2.6
|
In the event of (i) a sale of the shares of the Company or (ii) a change of control it is the expectation of the Parties that the obligations of the Company with respect to revenue sharing under this Agreement remain binding on the Company despite the change in ownership of the shares of the Company. For clarity the Trust shall not be entitled to a share of the net proceeds received by the shareholders of the Company on a sale of the shares of the Company unless the Trust is a shareholder in the Company at the relevant time.
|
3.1
|
Where Direct Costs incurred/allowed in a given accounting year exceed the Revenue from Exploitation of Exploitation IPRs for that year, then such excess costs shall be carried forward and offset against future Revenue until such time as they have been fully recovered.
|
4.1
|
Within [**] days of the end of each Calendar Quarter, the Company shall deliver a statement to the Trust setting out for the relevant Calendar Quarter:
|
(a)
|
Revenue and Net Revenue received;
|
(b)
|
deductible Direct Costs and taxes;
|
(c)
|
sales of Licensed Products made by any member of the Company's Group or any Third Party;
|
(d)
|
the share of Net Revenue due to the Trust pursuant to Clause 2.1 above; and
|
(e)
|
cumulative Revenue, cumulative Net Revenue and cumulative Direct Costs;
|
4.2
|
The Trust shall deliver to the Company an invoice for the amount due to it as set out in the Quarterly Statement in pounds sterling.
|
4.3
|
The share of Net Revenue due to the Trust and any other amount invoiced shall be payable to the Trust within [**] days of receipt of the invoice.
|
4.4
|
All payments of Net Revenue made by the Company to the Trust or by the Trust to the Company as the case may be under this Agreement shall be made in pounds sterling. Payment shall be made by electronic wire transfer of immediately available funds directly to the account of the relevant Party designated below or to any other account which the relevant Party may specify by written notice in accordance with Clause 6.
|
4.5
|
Bank Account for the
Trust:
|
4.6
|
Written confirmation of such transfer shall be sent by the Party sending the funds to the individual at the Party receiving the funds at the address provided in Clause 6 below.
|
4.7
|
Where any Revenue and Direct Costs in respect of the Exploitation IPRs is received or made in a currency other than sterling, the sterling equivalent of the sum shall be:
|
(a)
|
where such sum has been converted into sterling prior to preparation of the Quarterly Statement, the actual sterling sum on conversion; or
|
(b)
|
where such conversion has not taken place prior to preparation of the Quarterly Statement, calculated using the average of the buying and selling rates quoted by [**] at the date the sum is received or paid by the Exploiting Party as applicable, or at such other date as the paying Party may reasonably specify having regard to the circumstances.
|
4.8
|
If the paying Party fails to pay any amount payable by it under this Agreement on the relevant due date, interest shall accrue on the overdue amount from the due date up to the date of
|
4.9
|
The VAT registration details for the Company and the Trust:
|
(a)
|
VAT registration details for the Company: 876331407
|
(b)
|
VAT registration details for the
Trust: 744495211
|
4.10
|
All payments shall be made net of any withholding or similar tax payments required by law.
|
4.11
|
The Company shall keep such records as are reasonably necessary to enable a proper assessment to be made of the following for at least [**] years:
|
(a)
|
the sums payable under this Agreement;
|
(b)
|
Revenue and Net Revenue received;
|
(c)
|
deductible Direct Costs and taxes on the Exploitation IPRs;
|
(d)
|
sales of Licensed Products made by any member of the Company’s Group or any Third Party; and
|
(e)
|
cumulative Revenue, cumulative Net Revenue and cumulative Direct Costs;
|
4.12
|
The Company shall allow an independent accountant duly authorised on behalf of and at the expense of the Trust to inspect the Records by prior written appointment during normal business hours and not more than [**]. Such accountant shall not disclose to any Third Party or use for any unauthorised purpose any information not relevant to the verification of the sums due to the Trust that is obtained as a result of any such inspection. The Company shall procure that these inspection and audit rights extend to the records of the Company’s Group and any sub-licensees thereof.
|
4.13
|
The Trust shall pay for the audit as well as its own legal expenses associated with enforcing its rights with respect to any payments due under this Agreement except where the audit reveals a discrepancy of [**] percent ([**]%) or more of any sums paid or payable, in which case the costs of the audit shall be paid by the Company.
|
5.1
|
This Agreement shall commence on the Effective Date and shall continue for whichever is the longer of:
|
(a)
|
the last to expire of the Project Patents;
|
(b)
|
the expiry of any agreement entered into by Company with a Third Party for the Exploitation of the Project IPRs; or
|
(c)
|
the expiry of any payment obligation owed to the Trust relating to the Exploitation of the Project IPRs.
|
5.2
|
Either Party shall have the right to terminate this Agreement forthwith at any time (“
Terminating Party
”) upon giving written notice of termination to the other Party (“
Defaulting Party
”), upon the occurrence of any of the following events:
|
(a)
|
the Defaulting Party commits a breach of a material obligation set out in this Agreement which is not capable of remedy;
|
(b)
|
the Defaulting Party commits a breach of a material obligation set out in this Agreement which is capable of remedy but has not been remedied within [**] days of the receipt by it of a notice from the other Party identifying the breach and requiring its remedy;
|
(c)
|
the Defaulting Party is unable or admits inability to pay its debts as they fall due, suspends making payments on any of its debts or, by reason of actual or anticipated financial difficulties commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;
|
(d)
|
a proposal is made or a nominee or supervisor is appointed for a composition in satisfaction of the debts of the Defaulting Party or a scheme or voluntary arrangement of its affairs within the meaning of the relevant bankruptcy or insolvency laws, or the Defaulting Party enters into any composition or voluntary arrangement for the benefit of its creditors, or proceedings are commenced in relation to the Defaulting Party under any law, regulation or procedure relating to the re-construction, deferment or re-adjustment of all or substantially all of the Defaulting Party’s debts;
|
(e)
|
the Defaulting Party takes any action, or any legal proceedings are started whether by a Third Party or not, for the purpose of the winding up or dissolution of the Defaulting Party, other than for a solvent reconstruction or amalgamation;
|
(f)
|
the appointment of a liquidator, trustee, receiver, administrative receiver, receiver and manager, interim receiver custodian, sequestrator, administrator or similar officer, in respect of all or a substantial part of the assets of the Defaulting Party;
|
(g)
|
an effective resolution being passed for the winding-up or entering into administration (whether out of court or otherwise) of the Defaulting Party;
|
(h)
|
a distress, execution or other legal process being levied against all or substantially all of the assets of the Defaulting Party, and not being discharged or paid out in full within [**] Business Days of the commencement of each process;
|
(i)
|
the occurrence in respect of the Defaulting Party of any event in any jurisdiction to which it is subject having an effect similar to that of any of the events referred to in Clauses 5.2(c)to 5.2(h)above.
|
6.1
|
Any notice to be given pursuant to this Agreement shall be in writing in the English language and shall be delivered by overnight courier, by registered, recorded delivery or certified mail (postage prepaid) or by email confirmed by registered, recorded delivery or certified mail (postage prepaid) to the address or email address of the recipient Party set out below or such other address or email address as a Party may from time to time designate to the other Party.
|
6.2
|
Address of Company
|
6.3
|
Address of the Trust
|
6.4
|
Any notice given pursuant to Clause 6.1 shall be deemed to have been received in the case of delivery by courier or by certified mail, on the day of receipt, provided receipt occurs on a Business Day or otherwise on the next following Business Day.
|
7.1
|
As the Company is taking RDZ through Phase III trials, the Parties hereby agree that Clause 16 (Unexploited IPRs), shall be deleted from the TA Funding Agreement with effect from the Effective Date. Furthermore, the Parties have agreed that Clauses 5.2, 5.3, 12, 13, 14.3, 17 and 18 shall be deleted from the TA Funding Agreement with effect from the Effective Date and that Clauses 2, 3, 4, 6, 10, 11, 14.1, 14.3, 14.5, 14.7, 14.8, 14.9, 14.10, 14.11, 15 and 19 are, from the Effective Date, no longer applicable as they relate to the performance of the Project which has now been completed.
|
7.2
|
This Agreement is in addition to the TA Funding Agreement (as may be amended from time to time), which, subject to Clause 7.1 above, will continue to apply unless terminated on its terms. Should there be any conflict between this Agreement and the TA Funding Agreement, then this Agreement shall prevail. For clarity, Clauses 7, 8, 9, 20, 23, 24, 28, 30.1, 30.3 and 30.4 from the TA Funding Agreement are still applicable and shall be imported into this Agreement by operation of this Clause.
|
7.3
|
Nothing in this Agreement shall give rise to any partnership or the relationship of principal and agent between the Trust and the Company.
|
7.4
|
All notices and communications shall be in writing and addressed to the Parties at the relevant address stated at the beginning of this Agreement (or such other address as may be notified from time to time).
|
7.5
|
None of the rights or obligations under this Agreement may be assigned or transferred without the prior written consent of the other Party. This Agreement shall be binding on and enure for the benefit of the successors in title of the Parties.
|
7.6
|
No waiver of any breach or default under this Agreement or any of the terms herein shall be effective unless such waiver is in writing and has been signed by the Parties. No waiver of any such breach or default shall constitute a waiver of any other or subsequent breach or default.
|
7.7
|
If any provisions of this Agreement are held to be invalid, illegal or unenforceable (in whole or in part) such provisions or parts shall to that extent be deemed not to form part of this Agreement but the remainder of this Agreement shall continue in full force and effect.
|
7.8
|
Each Party shall do and execute or arrange for the doing or executing of all acts, documents and things as may be necessary in order to implement this Agreement.
|
7.9
|
This Agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this Agreement or its formation) shall be governed by and construed in accordance with the laws of England. The Parties irrevocably submit to the exclusive jurisdiction of the Courts of England.
|
Signed for and on behalf of
SUMMIT (OXFORD) LIMITED
by its duly authorised representative:
|
|
|
||
Signature:
|
/s/ Glyn Edwards
|
|
|
|
Name:
|
Glyn Edwards
|
|
|
|
Title:
|
Director
|
|
|
|
|
|
|
||
Signed for and on behalf of
THE WELLCOME TRUST LIMITED
as trustee of the Wellcome Trust
by its duly authorised representative:
|
|
|
||
Signature:
|
/s/ Iain Ward
|
|
|
|
Name:
|
Iain Ward
|
|
|
|
Title:
|
Associate General Counsel Innovations
|
|
|
|
(i)
|
direct materials (including shipping);
|
(ii)
|
direct labour;
|
(iii)
|
indirect manufacturing costs;
|
(iv)
|
quality assurance, and
|
(v)
|
certain variances as set out in 5 below, but not including other production costs, as identified below.
|
•
|
Base pay, overtime, vacation and holidays, illness, personal time with pay and shift differential.
|
•
|
Cost of employee fringe benefits such as health and life insurance, payroll taxes, welfare, pension and profit sharing.
|
•
|
Indirect Production Labour
- salaries of employees engaged in production activities who are not classified as direct labour, including supervision, clerical, etc.
|
•
|
Costs of Direct Labour
- employees not utilized for the manufacturing of product such as training and general duties.
|
•
|
Indirect Materials
‑ supplies and chemicals which are used in the manufacturing process and are not assigned to specific products but are included in manufacturing overhead costs. Includes supplies for which direct assignment to products is not practical.
|
•
|
Utilities
‑ expenses incurred for fuel, electricity and water in providing power for production and other plant equipment and waste disposal.
|
•
|
Maintenance and Repairs
- amount of expense incurred in‑house or purchased to provide services for plant maintenance and repairs of facilities and equipment.
|
•
|
Other Services
‑ purchased outside services and rentals such as the cost of security, ground maintenance, etc.
|
•
|
Depreciation
- of plant and equipment utilizing the straight‑line method of calculation.
|
•
|
Insurance
‑ cost of comprehensive and other insurance necessary for the safeguard of manufacturing plant and equipment.
|
•
|
Taxes
‑ expense incurred for taxes on real and personal property (manufacturing site, buildings and the fixed assets of equipment, furniture and fixtures, etc.) If manufacturing site includes other operations (marketing, R&D, etc.), taxes are allocated to manufacturing on the basis of total real and personal property.
|
•
|
Cost of manufacturing, service departments
- such as:
|
•
|
Packaging Engineering
|
•
|
Manufacturing Maintenance
|
•
|
Industrial Engineering
|
•
|
Receiving and Warehousing
|
•
|
Purchasing and Accounting
|
•
|
Production Scheduling
|
•
|
Inventory Management
|
•
|
Plant Materials Management
|
•
|
Central Weigh
|
•
|
Manufacturing Administration
|
•
|
Allocated costs of services provided to manufacturing
including: (where applicable)
|
•
|
Cafeteria
|
•
|
Personnel Operations
|
•
|
Health and Safety Services
|
•
|
Division Engineering and Operations Services
|
•
|
Plant Services (housekeeping)
|
•
|
Manufacturing Information Systems
|
•
|
Plant Power
|
•
|
Office of V.P. Manufacturing
|
•
|
Standard Cost of Goods include cost elements which are set at so-called standard costs. They serve as a norm on how much typically a product costs. Deviations from such standard costs are captured in variances.
|
•
|
Inventory re/devaluation shall mean the gain or loss as a result of the inventory value adjustment due to changes in the standard costs.
|
•
|
Non-product related production costs shall contain Technical Operations Corporate Headquarter overhead costs, non-product allocated QA costs, validation costs, directly expensed IT project costs, and other costs that cannot be attributed to specific products.
|
•
|
Warehousing & Distribution costs are costs related to warehousing and distribution activities for Finished Goods to be shipped to 3rd parties.
|
•
|
Write-offs are captured for the destruction of products that cannot be used anymore due to expiration of shelf-life, spoilage in the production process, and transportation mishaps.
|
•
|
Third Party royalties for manufacturing or marketing, and/or supply royalties paid to third parties
|
◦
|
Product liability and/or business interruption insurance expenses, and
|
◦
|
Patent maintenance costs
|
a)
|
Inventory Carrying Costs
|
b)
|
Regulatory Affairs Costs
|
c)
|
Significant idle capacity is eliminated from factory overhead and product cost.
|
d)
|
Intracompany profit.
|
"Direct Costs"
|
means any costs and expenses incurred or allowed from time to time in accordance with this Agreement by or for the account of the Trust or the Company (as appropriate) in prosecuting, maintaining, enforcing or defending any of the Exploitation IPRs, marketing the Exploitation IPRs and negotiating, concluding or enforcing agreements for the licensing or other Exploitation of the Exploitation IPRs (including by way of acquisition of equity in a company), including without limitation:
(a) all reasonable legal, accounting and other professional fees and charges;
(b) official filing, prosecution, maintenance and renewal fees;
(c) travelling and other out-of-pocket expenditure; and
(d) Cost of Goods;
|
"Net Revenue"
|
means Revenue less:
(a) any Direct Costs;
(b) any applicable VAT on Revenue and/or Direct Costs;
(c) amounts repaid or credited and allowances including cash, credit or free goods allowances, given by reason of billing errors, discounts, actually allowed or paid or accrued;
(d) amounts refunded or credited for Licensed Products which were rejected or damaged or recalled or by reason of reasonable purchase chargebacks or rebates;
(e) freight, postage and shipping insurance invoiced to the Third Party;
(f) taxes, tariffs, customs duties and surcharges and other governmental charges incurred in connection with the sale, exportation or importation of Licensed Products; and
(g) government mandated and other reasonable rebates (such as those in respect of any state or federal Medicare or Medicaid or similar programs).
The transfer of Licensed Products between the Company and any of its Affiliates shall not be considered a sale for the purposes of calculating Revenue. In such cases, Revenue shall be determined on the gross invoiced price levied by the Affiliate on a Third Party, less the aforementioned deductions to the extent they are allowed, paid or accrued.
Any Licensed Product which is transferred by the Company or its Affiliates to a Third Party on less than arm’s length terms shall be deemed for the purposes of calculation of Revenue to be a sale at the list price of Licensed Product provided always that the use of Licensed Product in clinical trials shall not give rise to any deemed sale under this definition.
Transfers or dispositions of Licensed Product free of charge and in line with normal industry practice (a) for charitable purposes; (b) for non-commercial manufacturing purposes; (c) as free promotional samples of Licensed Product; or (d) for regulatory or governmental purposes shall not in each case be deemed "sales" for the purposes of calculating Revenue;
|
"Revenue"
|
means the pre-tax gross receipts actually received by the Company and its Affiliates from time to time in respect of the Exploitation of Exploitation Project IPRs and/or Licensed Products, whether by grant of a licence or an option thereto in respect of any Exploitation IPRs and/or Licensed Products, the assignment of the Exploitation IPR or otherwise, including, without limitation, gross receipts representing sales of the Licensed Products, cash sums, other monetary sums, royalties, licences fees, signature fees, lump sum payments or otherwise and/or any other consideration actually received by the Company and/or its Affiliates such as the provision of premises, equipment or cross licences. Where any consideration comprising Revenue is received other than in money the value of the consideration shall be determined by reference to the Fair Value of the goods, services, licence or other benefit to the Exploiting Party as at the date of receipt by the Company and/or its Affiliates. The Company shall pay to the Trust an amount in cash as required to satisfy the Trust's share of the Fair Value at the time it converts the non-cash consideration into cash. If the Parties are unable to agree on the Fair Value such dispute shall be referred to an expert under Clause 20 of the Funding Agreement. For the avoidance of doubt, Revenues shall include any award of damages received by the Company and/or its Affiliates in respect of enforcement of the Exploitation IPRs, less the costs of such action. For the further avoidance of doubt, Revenue shall not include any equity investment made in the Company by a Third Party or money paid to the Company by way of a grant.
|
(1)
|
Summit Therapeutics plc
whose registered office is at 136a Eastern Avenue, Milton Park, Abingdon, Oxfordshire, OX14 4SB (the “
Company
”); and
|
(2)
|
[NON-EXECUTIVE DIRECTOR NAME AND ADDRESS]
(the “
RSU Holder”
).
|
1
|
DEFINITIONS AND INTERPRETATION
|
1.1
|
In this Schedule, unless otherwise stated, the words and expressions below have the following meanings:
|
“ADS"
|
an American Depositary Share being an authorised depositary security denominated in US dollars and listed on NASDAQ which represents a number of Shares and which may be evidenced by an American Depositary Receipt
;
|
“ADS Ratio”
|
the ratio of Shares per ADS in place from time to time that indicates the number of Shares that an ADS represents, which at the date of grant is five Shares to one ADS;
|
“AIM”
|
a market operated by the London Stock Exchange;
|
“AIM Rules”
|
the rules for companies whose shares are admitted to trading on AIM published by the London Stock Exchange;
|
“Board”
|
subject to clause 10.8, the board of the Company, any duly authorised committee of the board or other duly authorised committee acting under delegated authority from the board
;
|
"Code"
|
the United States Internal Revenue Code 1986, as amended;
|
“Company”
|
Summit Therapeutics plc registered in England and Wales under number 05197494
;
|
“Control”
|
the meaning given by section 995 of the Income Tax Act 2007;
|
“Dealing Day”
|
any day on which the London Stock Exchange is open for business;
|
“Dealing Restrictions”
|
restrictions imposed by the Company’s share dealing code, the AIM Rules or any applicable laws or regulations which impose restrictions on share dealing;
|
“Exercise Price”
|
the price per Share at which Shares subject to the RSU may be acquired on the exercise of the RSU (being not less than the nominal value of a Share) as set out in clause 2.1, as adjusted from time to time in accordance with the terms of this Agreement;
|
“Grant Date”
|
the date of this Agreement
;
|
“Group Member”
|
the Company, any Subsidiary of the Company, any company which is (within the meaning of section 1159 of the Companies Act 2006) the Company’s holding company or a Subsidiary of the Company’s holding company or, if the Board so determines, any body corporate in relation to which the Company is able to exercise at least 20% of the equity voting rights and “Group” will be construed accordingly;
|
“Internal Reorganisation”
|
where immediately after a change of Control of the Company, all or substantially all of the issued share capital of the acquiring company is owned directly or indirectly by the persons who were shareholders in the Company immediately before the change of Control;
|
“Market Value”
|
on any day, an amount equal to:
(i)
in relation to a Share:
(a)
for so long as the Shares are quoted on AIM or another recognised stock exchange, the closing price of a Share on the relevant date, or if that is not a Dealing Day, the Dealing Day immediately preceding the relevant date; or
(b)
if the Shares are not quoted on any such exchange, the market value of a Share as determined in accordance with Part VIII Taxation of Chargeable Gains Act 1992 on the relevant date (or such earlier date as determined by the Board); and
(ii)
in relation to an ADS, the closing price of an ADS on the relevant date, or if that is not a Dealing Day, the Dealing Day immediately preceding the relevant date.
|
“Normal Vesting Date”
|
the date on which the RSU will normally Vest, which shall be the first anniversary of the Grant Date;
|
“Office”
|
the office of non-executive director of the Company;
|
“RSU”
|
the restricted stock unit representing a right to acquire Shares subject to and in accordance with the terms of this Agreement
;
|
“Section 409A”
|
Section 409A of the Code;
|
“Share”
|
a fully paid ordinary share of 0.1p in the capital of the Company
;
|
“Subsidiary”
|
the meaning given by section 1159 of the Companies Act 2006;
|
“Tax Liability”
|
any tax or social security contributions liability in connection with the RSU for which the RSU Holder is liable and for which any Group Member or former Group Member is obliged to account to any relevant authority;
|
“US Taxpayer”
|
the RSU Holder, to the extent she is a:
a.
US citizen;
b.
US permanent resident (evidenced by a green-card);
c.
non-US citizen who moves to the United States on or after the Grant Date and who is (or is expected to become) subject to US taxation as a resident alien; or
d.
non-US citizen to the extent that she is or becomes subject to Section 409A, including a non-resident alien taxpayer, with respect to all or some portion of the RSU that is deemed to be income from a US source; and
|
“Vest”
|
the point at which the RSU becomes capable of exercise in accordance with this Agreement, and “Vesting”, “Vesting Date”, “Vested” and “Unvested” will be construed accordingly.
|
1.2
|
References in this Agreement to:
|
1.2.1
|
any statutory provisions are to those provisions as amended or re-enacted from time to time;
|
1.2.2
|
the singular include the plural and vice versa; and
|
1.2.3
|
the masculine include the feminine and vice versa.
|
1.3
|
Headings do not form part of this Agreement.
|
1.4
|
This Agreement and the RSU granted pursuant to this are intended to comply with Section 409A.
|
2
|
GRANT OF RSU
|
2.1
|
The Company hereby grants to the RSU Holder an RSU in the form of an option to acquire [NUMBER] Shares at the Exercise Price of £0.01 per Share subject to the provisions of this Agreement.
|
2.2
|
Subject to clause 8, the RSU may only be satisfied by:
|
2.2.1
|
the issue of new Shares; and/or
|
2.2.2
|
the transfer of Shares held by the Company in treasury.
|
3
|
RESTRICTIONS ON TRANSFER AND BANKRUPTCY
|
3.1
|
The RSU must not be transferred, assigned, charged or otherwise disposed of in any way (except in the event of the RSU Holder’s death, to her personal representatives) and will lapse immediately on any attempt to do so.
|
3.2
|
The RSU will lapse immediately if the RSU Holder is declared bankrupt or, if the RSU Holder is outside the UK, any analogous event occurs.
|
4
|
DIVIDEND EQUIVALENTS
|
4.1
|
The Board may decide at any time prior to the issue or transfer of the Shares following exercise of the RSU that the RSU Holder will receive an amount (in cash and/or additional Shares and/or ADSs) equal in value to any dividends that would have been paid on those Shares on such terms and over such period (ending no later than the Vest Date) as the Board may determine. This amount may assume the reinvestment of dividends (on such basis as the Board may determine) and may exclude or include special dividends.
|
4.2
|
Any such amount will be payable as soon as reasonably practicable after exercise of the RSU and, unless clause 6.2 applies, by no later than 31 December of the calendar year in which the RSU Vests.
|
5
|
REDUCTION OF RSU AND CLAWBACK
|
5.1
|
Notwithstanding any other term of this Agreement, the Board may, in its discretion and taking into account all relevant factors including the RSU Holder’s level of responsibility, determine that the provisions of either or both of clauses 5.3 and 5.4 should be applied in respect of the RSU if:
|
5.1.1
|
in the case of the provisions of clause 5.3, any of the circumstances described in clause 5.2 have occurred; and
|
5.1.2
|
in the case of the provisions of clause 5.4, any of the circumstances described in clauses 5.2.1 and 5.2.4 have occurred, within the period beginning on the Grant Date or such earlier date as the Board determines on or before the Grant Date and ending on the later of second anniversary of Vesting or fifth anniversary of the Grant Date, or such longer period as is required under any US Securities and Exchange Commission (“SEC”) rules that are applicable to the Company in respect of the RSU Holder.
|
5.2
|
The circumstances referred to in clause 5.1 are:
|
5.2.1
|
a material misstatement of the Group’s audited financial results;
|
5.2.2
|
a material failure of risk management by the Company, any other Group Member or a relevant business unit;
|
5.2.3
|
serious reputational damage to the Company, any other Group Member or a relevant business unit;
|
5.2.4
|
material misconduct on the part of the RSU Holder; or
|
5.2.5
|
any other circumstances which the Board in its discretion considers to be similar in their nature or effect.
|
5.3
|
The Board may, in its discretion, determine at any time prior to the Vest of the RSU to:
|
5.3.1
|
reduce (including to zero) the number of Shares to which the RSU relates or may relate; and/or
|
5.3.2
|
impose further conditions on the RSU.
|
5.4
|
Subject to clause 5.5, the Board may, in its discretion, determine that at any time after the Vesting of the RSU and prior to the later of the second anniversary of Vesting and the fifth anniversary of the Grant Date (or such longer period as is required by SEC rules that are applicable to the Company) to:
|
5.4.1
|
take the action referred to in clauses 5.3.1 or 5.3.2 if a Vested RSU has not yet been exercised, or if Shares or cash have not yet been delivered to the RSU Holder following the exercise of the RSU; and/or
|
5.4.2
|
require the RSU Holder to make a cash payment to the Company in respect of some or all of the Shares or cash delivered to her under the RSU; and/or
|
5.4.3
|
require the RSU Holder to transfer for nil consideration some or all of the Shares delivered to her under the RSU, and the Board will have discretion to determine the basis on which the amount of cash or Shares is calculated including whether and if so to what extent to take account of any tax or social security liability applicable to the RSU.
|
5.5
|
If the action or conduct of the RSU Holder, Group Member or relevant business unit is under investigation prior to the second anniversary of the Vest Date and such investigation has not yet been concluded by that date, the period referred to in clause 5.4 will end on such later date as the Board considers appropriate to allow such investigation to be concluded.
|
5.6
|
For the purposes of this clause 5, references to Group Member or a relevant business unit include references to any former Group Member or former business unit.
|
6
|
VESTING AND EXERCISE
|
6.1
|
Subject to clauses 7, 9, and 10, the RSU will Vest on the Normal Vesting Date and the RSU may then be exercised in accordance with the terms of this clause 6 until 31 December of the calendar year in which the RSU Vests, after which point the RSU will lapse unless clause 6.2 applies.
|
6.2
|
If, on the Normal Vesting Date (or on any other date on which the RSU is due to Vest under clauses 9 or 10) a Dealing Restriction applies to the RSU which does not lift prior to 31 December of the calendar year in which the RSU Vests, the RSU may then be exercised to the extent Treas. Reg. §1.409A-2(b)(7)(ii) is applicable when the Dealing Restriction lifts and in no event later than 31 December of the calendar year in which the Dealing Restriction lifts.
|
6.3
|
To exercise the RSU, the RSU Holder must pay the aggregate Exercise Price for the Shares subject to the RSU, or enter into arrangements acceptable to the Board to pay that amount.
|
6.4
|
Subject to clause 7, the RSU may be exercised pursuant to this clause 6 or clause 9 or 10 in such form or manner as the Board may determine, provided that exercise of the RSU will not take effect until the Company receives payment of the aggregate Exercise Price or an undertaking to pay that amount and a notice of exercise of the RSU.
|
6.5
|
Subject to clauses 7 and 8, where the RSU has been exercised, the number of Shares in respect of which the RSU has been exercised, together with any additional Shares, ADSs or cash to which the RSU Holder becomes entitled under clause 4, will be issued, transferred or paid (as applicable) to the RSU Holder as soon as reasonably practicable thereafter and, unless clause 6.2 applies, by no later than 31 December of the calendar year in which the RSU Vests.
|
7
|
TAXATION AND REGULATORY ISSUES
|
7.1
|
The RSU Holder will be responsible for and indemnifies each relevant Group Member against any Tax Liability relating to her RSU. Any Group Member may withhold an amount equal to such Tax Liability from any amounts due to the RSU Holder (to the extent such withholding is lawful) and/or make any other arrangements as it considers appropriate to ensure recovery of such Tax Liability including, without limitation, the sale of sufficient Shares or ADSs acquired subject to the RSU to realise an amount equal to the Tax Liability.
|
7.2
|
The exercise of the RSU and the issue, or transfer from treasury, of Shares or ADSs under this Agreement will be subject to obtaining any approval or consent required by any relevant authority, any Dealing Restrictions or any other applicable laws or regulations (whether in the UK or overseas).
|
8
|
ALTERNATIVE MEANS OF SETTLEMENT
|
8.1
|
The Board may determine t at any time prior to the date on which Shares in respect of which the RSU has been exercised have been issued or transferred to the RSU Holder that, in substitution for her right to acquire the Shares to which her RSU relates, the RSU Holder will instead receive on exercise of her RSU either:
|
8.1.1
|
a cash sum in accordance with clause 8.2;
|
8.1.2
|
a reduced number of Shares in accordance with clause 8.3; or
|
8.1.3
|
a number of ADSs in accordance with clause 8.4, provided that the issue of ADSs to the RSU Holder does not breach any securities laws or regulation in the US or any other relevant jurisdiction.
|
8.2
|
A cash sum to which the RSU Holder becomes entitled under this clause 8.2 will be equal to the Market Value of the number of Shares which would otherwise have been issued or transferred, less the aggregate Exercise Price payable, to the RSU Holder in satisfaction of the exercise of the RSU and for these purposes:
|
8.2.1
|
Market Value will be determined by reference to the date of exercise; and
|
8.2.2
|
the cash sum will be paid to the RSU Holder as soon as reasonably practicable after the exercise of the RSU (or, if later, the date of such determination) net of any deductions (including but not limited to, any Tax Liability or similar liabilities) as may be required by law and, unless clause 6.2 applies, by no later than 31 December of the calendar year in which the RSU Vests.
|
8.3
|
The number of Shares to which the RSU Holder becomes entitled under this clause 8.3 will be equal to the Market Value of that number of Shares which would otherwise have been issued or transferred to the RSU Holder in satisfaction of the exercise of the RSU, less any deducti
|
8.3.1
|
Market Value will be determined by reference to the date of exercise;
|
8.3.2
|
the number of Shares to which the RSU Holder is entitled will be issued or transferred to her as soon as reasonably practicable after the exercise of the RSU and, unless clause 6.2 applies, by no later than 31 December of the calendar year in which the RSU Vests.
|
8.4
|
The number of ADSs to which the RSU Holder becomes entitled under this clause 8.4 will be calculated by applying the ADS Ratio in force as at the date of exercise to the number of Shares which would otherwise have been issued or transferred to the RSU Holder in satisfaction of the exercise of the RSU, and for these purposes:
|
8.4.1
|
Market Value will be determined by reference to the date of exercise; and
|
8.4.2
|
subject clause 7, the number of ADSs to which the RSU Holder is entitled will be issued or transferred to her as soon as reasonably practicable after the exercise of the RSU and, unless clause 6.2 applies, by no later than 31 December of the calendar year in which the RSU Vests.
|
9
|
CESSATION OF OFFICE
|
9.1
|
If the RSU Holder dies prior to the Normal Vesting Date, if the RSU is Unvested as of the date of her death, it will Vest in full as of the date of death.
|
9.2
|
If the RSU Vests in accordance with clause 9.1, or was already Vested but not yet exercised at the date of death, it may then be exercised, subject to clause 10, on or before 31 December in the calendar year of Vest, after which time it will lapse unless clause 6.2 applies.
|
9.3
|
If the RSU Holder ceases to hold Office prior to the Normal Vesting Date for any reason other than death, the RSU will continue and, subject to it Vesting and lapsing earlier under clause 10, will Vest and be exercisable in accordance with clause 6.1.
|
10
|
CORPORATE EVENTS
|
10.1
|
Where any of the events described in clause 10.2 or 10.3 occur and such event is a change in ownership or effective control as provided in Section 409A(a)(2)(v) and Treas. Reg. §1.409A-3(i)(5), subject to clauses 10.6 and 10.7, if the RSU is not yet Vested, it will Vest in full at the time of such event. The RSU will be exercisable until 31 December in the calendar year of Vest after which time it will lapse unless clause 6.2 applies.
|
10.2
|
The events referred to in clause 10.1 are:
|
10.2.1
|
General offer
|
10.2.1.1
|
obtains Control of the Company as a result of making a general offer to acquire Shares; or
|
10.2.1.2
|
already having Control of the Company, makes an offer to acquire all of the Shares other than those which are already owned by her and such offer becomes wholly unconditional.
|
10.2.2.
|
Scheme of arrangement
|
10.3
|
If a person becomes bound or entitled to acquire Shares under sections 979 to 982 or 983 to 985 of the Companies Act 2006 (takeover offers: right of offeror to buy out minority shareholder etc.), the RSU will Vest in full and may be exercised during the period while that person remain
|
10.4
|
Winding-up
|
10.5
|
Other events
|
10.5.1
|
the RSU will Vest in full on such terms as the Board may determine; and
|
10.5.2
|
the Board will determine the period during which any Vested RSU may be exercised (provided, unless clause 6.2 applies, that this does not end later than 31 December of the calendar year of Vesting), after which time it will lapse.
|
10.6
|
Exchange
|
10.6.1
|
an offer to exchange the RSU (the “
Existing RSU
”) is made and accepted by the RSU Holder;
|
10.6.2
|
there is an Internal Reorganisation, unless the Board determines that the RSU should Vest under clause 10.1; or
|
10.6.3
|
the Board decides (before the relevant event) that the Existing RSU will be exchanged automatically.
|
10.7
|
Exchange terms
|
10.8
|
Meaning of Board
|
11
|
ADJUSTMENTS
|
11.1
|
The number of Shares subject to the RSU and the Exercise Price of the RSU may be adjusted in such manner as the Board determines, in the event of:
|
11.1.1
|
any variation of the share capital of the Company; or
|
11.1.2
|
a demerger, delisting, special dividend or other similar event which may, in the opinion of the Board, affect the current or future value of Shares.
|
12
|
AMENDMENTS
|
12.1
|
The Board may at any time amend the terms of the RSU by written agreement with the RSU Holder.
|
13
|
LEGAL ENTITLEMENT
|
13.1
|
This clause 13 applies during the RSU Holder’s Office and after cessation of such Office.
|
13.2
|
The grant of the RSU to the RSU Holder does not create any right for that RSU Holder to be granted any further RSUs or to be granted RSUs on any particular terms, including the number of Shares to which RSUs relate.
|
13.3
|
The RSU Holder acknowledges that nothing in the Agreement will confer on her any right to continue in Office.
|
13.4
|
The RSU Holder waives all rights to compensation for any loss in relation to the RSU, including:
|
13.4.1
|
any loss or reduction of any rights or expectations under the Agreement in any circumstances or for any reason;
|
13.4.2
|
any exercise of a discretion or a decision taken in relation to the RSU, or any failure to exercise a discretion or take a decision; and
|
14
|
GENERAL
|
14.1
|
Shares issued or transferred from treasury under this Agreement will rank equally in all respects with the Shares then in issue, except that they will not rank for any voting, dividend or other rights attaching to Shares by reference to a record date preceding the date of issue or transfer from treasury.
|
14.2
|
The Board will have full authority to interpret and construe any provision of this Agreement and decisions of the Board will be final and binding on all parties.
|
14.3
|
Any notice or other communication in connection with the Agreement may be delivered personally or sent by electronic means or post, in the case of a company to its registered office (for the attention of the company secretary), and in the case of an individual to her last known address. Where a notice or other communication is given by post, it will be deemed to have been received 72 hours after it was put into the post properly addressed and stamped, and if by electronic means, when the sender receives electronic confirmation of delivery or if not available, 24 hours after sending the notice.
|
14.4
|
No third party will have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of the Agreement (without prejudice to any right of a third party which exists other than under that Act).
|
14.5
|
The RSU Holder consents to the holding and processing of personal data provided by the RSU Holder to the Company for all purposes relating to the Agreement, including but not limited to administering and maintaining RSU Holder records, providing information to any registrars, brokers or other third party administrators, providing information to future purchasers of the Company or the business in which the RSU Holder works and transferring information about the RSU Holder to a country or territory outside the European Economic Area or elsewhere.
|
14.6
|
The RSU evidenced by this Agreement is intended to comply with the requirements of Section 409A and any ambiguities herein will be interpreted to so comply. The RSU Holder shall have no right to accelerate or defer any payment hereunder unless such acceleration or deferral is permitted by Section 409A. The Company makes no representation or warranty and shall have no liability to the RSU Holder or any other person if any provisions or payments, compensation or other benefits under the RSU are determined to constitute nonqualified deferred compensation subject to Section 409A but do not satisfy the conditions of that section.
|
14.7
|
This Agreement will be governed by and construed in accordance with the laws of England and Wales. Any person referred to in this Agreement submits to the exclusive jurisdiction of the Courts of England and Wales.
|
|
)
)
)
|
|
||
|
|
Director
Director/Secretary
|
||
SIGNED
AS A DEED
(but not delivered until dated) by
[NON-EXECUTIVE DIRECTOR NAME]
in the presence of:-
Signature of witness:
Name of witness:
Address:
Occupation:
|
)
)
)
|
|
|
|
|
Name of Subsidiary
|
|
Jurisdiction of incorporation
or organization |
Summit Therapeutics Inc.
|
|
Delaware, USA
|
Summit Corporation Limited
|
|
England and Wales
|
Summit (Oxford) Limited
|
|
England and Wales
|
Summit (Wales) Limited
|
|
England and Wales
|
Summit (Cambridge) Limited
|
|
England and Wales
|
Summit Discovery 1 Limited
|
|
England and Wales
|
Summit Corporation Employee Benefit Trust Company Limited
|
|
England and Wales
|
MuOx Limited
|
|
England and Wales
|
Discuva Limited
|
|
England and Wales
|
Summit Infectious Diseases Limited
|
|
England and Wales
|
By:
|
/
S
/ Glyn Edwards
|
|
|
Name:
|
Glyn Edwards
|
|
Title:
|
Chief Executive Officer
|
By:
|
/s/ Erik Ostrowski
|
|
|
Name:
|
Erik Ostrowski
|
|
Title:
|
Chief Financial Officer
|
|
|
|
By:
|
/s/ Glyn Edwards
|
|
|
Name:
|
Glyn Edwards
|
|
Title:
|
Chief Executive Officer
|
|
|
|
By:
|
/s/ Erik Ostrowski
|
|
|
Name:
|
Erik Ostrowski
|
|
Title:
|
Chief Financial Officer
|