Delaware
|
2834 | 14-1902018 | ||
(State or Other Jurisdiction
of
Incorporation or Organization) |
(Primary Standard Industrial
Classification Code No.) |
(I.R.S. Employer
Identification No.) |
David E. Redlick, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP 1875 Pennsylvania Avenue, NW Washington, DC 20006 (202) 663-6000 |
Daniel J.
Abdun-Nabi, Esq.
General Counsel Emergent BioSolutions Inc. 300 Professional Drive, Suite 250 Gaithersburg, Maryland 20879 (301) 944-0290 |
James A. Lebovitz, Esq.
Brian D. Short, Esq. Dechert LLP 2929 Arch Street Philadelphia, Pennsylvania 19104 (215) 994-4000 |
Title of Each
Class of
|
Proposed
Maximum
|
Amount of
|
||||
Securities to be Registered | Aggregate Offering Price(1) | Registration Fee(2) | ||||
Common stock, $0.01 par value
per share
|
$86,250,000 | $9,229 | ||||
Series A junior participating
preferred stock purchase rights(3)
|
| | ||||
(1) | Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(o) under the Securities Act. |
(2) | Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price. |
(3) | Each share of common stock includes one series A junior participating preferred stock purchase right pursuant to a rights agreement to be entered into between the Registrant and the rights agent. The series A junior participating preferred stock purchase rights will initially trade together with the common stock. The value attributable to the series A junior participating preferred stock purchase rights, if any, is reflected in the offering price of the common stock. |
The
information in this preliminary prospectus is not complete and
may be changed. We may not sell these securities until the
registration statement filed with the Securities and Exchange
Commission is effective. This preliminary prospectus is not an
offer to sell these securities, and we are not soliciting an
offer to buy these securities in any state where the offer or
sale is not permitted.
|
|
||||||||||||
Per share | Total | |||||||||||
|
||||||||||||
Initial public offering price
|
$ | $ | ||||||||||
Underwriting discounts and
commissions
|
$ | $ | ||||||||||
Proceeds to Emergent, before
expenses
|
$ | $ | ||||||||||
|
Page | ||||
Prospectus summary
|
1 | |||
Risk factors
|
8 | |||
Special note regarding
forward-looking statements
|
41 | |||
Use of proceeds
|
42 | |||
Dividend policy
|
42 | |||
Capitalization
|
43 | |||
Dilution
|
45 | |||
Selected consolidated financial
data
|
47 | |||
Managements discussion and
analysis of financial condition and results of operations
|
49 | |||
Business
|
72 | |||
Management
|
118 | |||
Certain relationships and related
party transactions
|
137 | |||
Principal and selling stockholders
|
143 | |||
Description of capital stock
|
150 | |||
Shares eligible for future
sale
|
158 | |||
Underwriting
|
160 | |||
Legal matters
|
163 | |||
Experts
|
164 | |||
Where you can find more information
|
164 | |||
Index to consolidated financial
statements
|
F-1 |
1
| Anthrax immune globulin for post-exposure treatment of anthrax infection; |
| Botulinum immune globulin for post-exposure treatment of illness caused by botulinum toxin, which we are developing based on a new botulinum toxoid vaccine that we are developing in collaboration with the U.K. Health Protection Agency, or HPA; and |
| Recombinant bivalent botulinum vaccine a prophylaxis for illness caused by botulinum toxin, which we also are developing in collaboration with HPA. |
| Typhoid vaccine a single dose, drinkable vaccine, for which we have completed a Phase I clinical program, including trials in the United States, the United Kingdom and Vietnam, and expect to initiate a Phase II clinical trial in Vietnam in the fourth quarter of 2006; |
| Hepatitis B therapeutic vaccine a multiple dose, drinkable vaccine for treatment of chronic carriers of hepatitis B infection, for which we have completed a Phase I clinical trial in the United Kingdom and expect to initiate a Phase II clinical trial in the United Kingdom in the second half of 2006; and |
| Group B streptococcus vaccine a multiple dose, injectable vaccine for administration to women of childbearing age for protection of the fetus and newborn babies, for which we have completed a Phase I clinical trial in the United Kingdom. |
2
| Maximize the commercial potential of BioThrax. We are focused on increasing sales of BioThrax to U.S. government customers, expanding the market for BioThrax to other customers and pursuing label expansions and improvements for BioThrax. The potential label expansions and improvements for BioThrax include an extension of shelf life, reductions in the number of required doses, addition of another method of administration and use as a post-exposure prophylaxis for anthrax infection in combination with antibiotic therapy. |
| Continue to develop a balanced portfolio of immunobiotic products. We seek to maintain a balanced product portfolio that includes both biodefense and commercial immunobiotic product candidates and both vaccines and therapeutics to diversify product development and commercialization risk. We expect that biodefense product candidates may generate revenues from product sales sooner than commercial product candidates because of Project BioShield, which allows the U.S. government to purchase biodefense products for the strategic national stockpile before they are approved by the FDA. |
| Focus on core capabilities in product development and manufacturing. We focus our efforts on immunobiotic product development and manufacturing, which we believe are our core capabilities. We seek to obtain marketed products and development stage product candidates through acquisitions and licensing arrangements with third parties. |
| Build large scale manufacturing infrastructure. To augment our existing manufacturing capabilities, we are constructing a new 50,000 square foot manufacturing facility on our Lansing, Michigan campus. We anticipate that we will initiate large scale manufacturing of BioThrax at our new Lansing facility in 2008. We also own two buildings in Frederick, Maryland that we plan to build out as future manufacturing facilities. |
| Selectively establish collaborations. For each of our product candidates, we plan to evaluate the merits of retaining commercialization rights or entering into collaboration arrangements with leading pharmaceutical or biotechnology companies or non-governmental organizations. We currently have collaborations with HPA and Sanofi Pasteur. |
| Seek governmental and other third party grants and support. To date, the CDC, the NIH and the Wellcome Trust have provided product development support or funding. We plan to encourage government entities and non-government and philanthropic organizations to continue to conduct studies of, and pursue other development efforts and provide development funding for, BioThrax and our product candidates. |
3
4
Common stock offered by us | shares | |
Common stock offered by the selling stockholders | shares if the underwriters exercise their over-allotment option in full | |
Common stock to be outstanding after this offering | shares | |
Use of proceeds | We expect to use the net proceeds from this offering, together with our existing cash and cash equivalents, revenues from BioThrax product sales and other committed sources of funds, to fund clinical trials, preclinical testing and other development activities and the balance for working capital, capital expenditures and other general corporate purposes. See Use of proceeds. | |
We will not receive any proceeds from the sale of shares of common stock by the selling stockholders as a result of the exercise by the underwriters of their over-allotment option. | ||
Risk factors | See Risk factors and other information in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock. | |
Proposed NASDAQ Global Market symbol | EBSI |
| 1,062,779 shares of common stock issuable upon the exercise of stock options outstanding as of July 31, 2006 at a weighted average exercise price of $6.38 per share; |
| 157,206 additional shares of common stock reserved for issuance under our employee stock option plan as of July 31, 2006; and |
| 175,000 additional shares of common stock that will be reserved for issuance under our 2006 stock incentive plan immediately prior to completion of this offering. |
| no exercise of the outstanding options described above; and |
| no exercise by the underwriters of their option to purchase up to shares of common stock from the selling stockholders to cover over-allotments. |
5
|
||||||||||||||||||||
Year ended December 31, | Three months ended March 31, | |||||||||||||||||||
(in thousands, except share and per share data) | 2003 | 2004 | 2005 | 2005 | 2006 | |||||||||||||||
|
||||||||||||||||||||
(unaudited) | ||||||||||||||||||||
Statements of operations
data:
|
||||||||||||||||||||
Revenues:
|
||||||||||||||||||||
Product sales
|
$ | 55,536 | $ | 81,014 | $ | 127,271 | $ | 14,782 | $ | 12,196 | ||||||||||
Milestones and grants
|
233 | 2,480 | 3,417 | 480 | 27 | |||||||||||||||
Total revenues
|
55,769 | 83,494 | 130,688 | 15,262 | 12,223 | |||||||||||||||
Operating expenses (income):
|
||||||||||||||||||||
Cost of product sales
|
22,342 | 30,102 | 31,603 | 4,136 | 2,861 | |||||||||||||||
Research and development
|
6,327 | 10,117 | 18,381 | 1,852 | 8,173 | |||||||||||||||
Selling, general &
administrative
|
19,547 | 30,323 | 42,793 | 8,849 | 10,587 | |||||||||||||||
Purchased in-process research and
development
|
1,824 | | 26,575 | | | |||||||||||||||
Settlement of State of Michigan
obligation
|
| (3,819 | ) | | | | ||||||||||||||
Litigation settlement
|
| | (10,000 | ) | | | ||||||||||||||
Total operating expenses
|
50,040 | 66,723 | 109,352 | 14,837 | 21,621 | |||||||||||||||
Income (loss) from operations
|
5,729 | 16,771 | 21,336 | 425 | (9,398 | ) | ||||||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest income
|
100 | 65 | 485 | 77 | 203 | |||||||||||||||
Interest expense
|
(293 | ) | (241 | ) | (767 | ) | (189 | ) | (170 | ) | ||||||||||
Other income (expense), net
|
168 | 6 | 55 | (13 | ) | 7 | ||||||||||||||
Total other income (expense)
|
(25 | ) | (170 | ) | (227 | ) | (125 | ) | 40 | |||||||||||
Net income (loss)
|
$ | 4,454 | $ | 11,472 | $ | 15,784 | $ | 224 | $ | (4,636 | ) | |||||||||
Earnings (loss) per
share basic
|
$ | 0.68 | $ | 1.74 | $ | 2.21 | $ | 0.03 | $ | (0.60 | ) | |||||||||
Earnings (loss) per
share diluted
|
$ | 0.63 | $ | 1.61 | $ | 2.00 | $ | 0.03 | $ | (0.60 | ) | |||||||||
Weighted average number of
shares basic
|
6,570,856 | 6,576,019 | 7,136,866 | 6,494,604 | 7,767,859 | |||||||||||||||
Weighted average number of
shares diluted
|
7,061,537 | 7,104,172 | 7,908,023 | 7,102,822 | 7,767,859 | |||||||||||||||
6
|
||||||||
As of March 31, 2006 | ||||||||
(in thousands) | Actual | As adjusted | ||||||
|
||||||||
(unaudited) | ||||||||
Balance sheet data:
|
||||||||
Cash and cash equivalents
|
$ | 14,774 | $ | |||||
Working capital
|
20,048 | |||||||
Total assets
|
90,573 | |||||||
Total long-term liabilities
|
10,225 | |||||||
Total stockholders equity
|
54,905 | |||||||
7
| the need to devote substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us; |
8
| the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded; and |
| the expenses that we might incur and the delays that we might suffer if our competitors protest or challenge contract awards made to us pursuant to competitive bidding, and the risk that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in termination, reduction or modification of the awarded contract. |
9
| procurement integrity; |
| export control; |
| government security regulations; |
| employment practices; |
| protection of the environment; |
| accuracy of records and the recording of costs; and |
| foreign corrupt practices. |
| terminate existing contracts, in whole or in part, for any reason or no reason; |
| reduce or modify contracts or subcontracts; |
10
| cancel multi-year contracts and related orders if funds for contract performance for any subsequent year become unavailable; |
| decline to exercise an option to renew a contract; |
| claim rights in products, including intellectual property, produced under the contract; |
| suspend or debar the contractor from doing business with the government or a specific government agency; |
| pursue criminal or civil remedies under the False Claims Act and False Statements Act; and |
| control or prohibit the export of products. |
| requiring us to dedicate a substantial portion of any cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes; |
| increasing the amount of interest that we have to pay on debt with variable interest rates if market rates of interest increase; |
| increasing our vulnerability to general adverse economic and industry conditions; |
| limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and |
| placing us at a competitive disadvantage compared to our competitors that have less debt. |
11
| the level of BioThrax product sales and cost of product sales; |
| the timing of, and the costs involved in, constructing our new manufacturing facility in Lansing, Michigan and the build out of our manufacturing facilities in Frederick, Maryland; |
| the scope, progress, results and costs of our preclinical and clinical development activities; |
| the costs, timing and outcome of regulatory review of our product candidates; |
| the number of, and development requirements for, other product candidates that we may pursue; |
| the costs of commercialization activities, including product marketing, sales and distribution; |
| the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including litigation costs and the results of such litigation; |
| the extent to which we acquire or invest in businesses, products and technologies; and |
| our ability to establish and maintain collaborations, such as our collaboration with Sanofi Pasteur. |
12
13
| equipment malfunctions or failures; |
| technology malfunctions; |
| work stoppages; |
| damage to or destruction of the facility due to natural disasters; |
| regional power shortages; |
| product tampering; or |
| terrorist activities. |
14
| fines, injunctions and civil penalties; |
| refusal by regulatory authorities to grant marketing approval of our product candidates; |
| delays, suspension or withdrawal of regulatory approvals, including license revocation; |
15
| seizures or recalls of product candidates or products; |
| operating restrictions; and |
| criminal prosecutions. |
16
| successful completion of preclinical development; |
| successful completion of clinical trials; |
| receipt of marketing approvals from the FDA and similar foreign regulatory authorities; |
| a determination by the Secretary of HHS that our biodefense product candidates should be purchased for the strategic national stockpile prior to FDA approval; |
| establishing commercial manufacturing processes or arrangements; |
| launching commercial sales of the product, whether alone or in collaboration with others; and |
| acceptance of the product by potential government customers, physicians, patients, healthcare payors and others in the medical community. |
17
| regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
| we may decide, or regulators may require us, to conduct additional preclinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our preclinical tests, clinical trials or animal efficacy trials produce negative or inconclusive results; |
| we might have to suspend or terminate our clinical trials if the participating patients are being exposed to unacceptable health risks; |
| regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements; |
| the cost of our clinical trials may be greater than we currently anticipate; |
| any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable; and |
| the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics. |
| be delayed in obtaining marketing approval for our product candidates; |
| not be able to obtain marketing approval; or |
| obtain approval for indications that are not as broad as intended. |
18
19
| the prevalence and severity of any side effects; |
| the efficacy and potential advantages over alternative treatments; |
| the ability to offer our product candidates for sale at competitive prices; |
| relative convenience and ease of administration; |
| the willingness of the target patient population to try new products and of physicians to prescribe these products; |
| the strength of marketing and distribution support; and |
| sufficient third party coverage or reimbursement. |
20
21
| Anthrax immune globulin. Cangene, in collaboration with the CDC, is currently developing an anthrax immune globulin product using plasma collected from military personnel vaccinated with BioThrax. In July 2006, HHS exercised an option under a modification to an existing development and supply contract for Cangene to supply 10,000 doses of anthrax immune globulin for the strategic national stockpile. This contract modification has a total value of approximately $143 million. Human Genome Sciences is developing a monoclonal antibody to Bacillus anthracis as a post-exposure therapeutic for anthrax infection. In June 2006, HHS awarded a contract with a value of $165 million to Human Genome Sciences to supply 20,000 treatment courses of the monoclonal antibody, referred to as ABthrax ® , for the strategic national stockpile. |
| Recombinant bivalent botulinum vaccine. DynPort Vaccine Company has a recombinant bivalent botulinum vaccine in Phase I clinical development with funding from the DoD and NIAID. AlphaVax and DOR BioPharma currently have botulinum vaccines in preclinical development. |
| Botulinum immune globulin. The current recommended therapy for clinical symptoms of botulism following exposure consists of passive immunization with an immune globulin derived from equine plasma. In June 2006, HHS awarded a five-year development and supply contract with a base value of |
22
$362 million to Cangene for a heptavalent botulinum immune globulin derived from equine plasma. The contract provides for the supply of 200,000 doses of a botulinum immune globulin for the strategic national stockpile. |
| Typhoid vaccine. One oral typhoid vaccine, Vivotif ® from Berna Biotech, and one injectable typhoid vaccine, sold as Typhim-Vi ® by Sanofi Pasteur and Typherix ® by GlaxoSmithKline, are currently approved and administered in the United States and Europe. Avant Immunotherapeutics is also developing an oral typhoid vaccine candidate. Antibiotics typically are used to treat typhoid after infection. |
| Hepatitis B therapeutic vaccine. There is no vaccine currently on the market that is licensed for therapeutic use for hepatitis B infection. Currently available therapies for this patient population consist mainly of antiviral drugs, such as an immunotherapy with interferons, including Epivir ® from GlaxoSmithKline and Hepsera ® from Gilead Sciences. Several other companies have vaccine candidates in clinical development. |
| Group B streptococcus vaccine. The existing method of prevention of group B streptococcus infection in neonates is the targeted administration of intravenous antibiotics to women during labor. A number of competitors have passive immune vaccines in preclinical development. |
| Chlamydia vaccine. There is no vaccine currently on the market for chlamydia, and we are not aware of any competing chlamydia vaccine candidate in clinical development. Several competitors may have chlamydia vaccine candidates in preclinical development. |
| Meningitis B vaccine. Currently, there is no meningitis vaccine on the market that is protective against group B meningococcal infection. Novartis markets a meningitis B vaccine in New Zealand to people under the age of 20 and is also developing a broad coverage protein subunit vaccine candidate. Current meningitis B treatment strategies include antibiotics and clinical support. |
23
24
| decreased demand for any product candidates or products that we may develop; |
| injury to our reputation; |
| withdrawal of clinical trial participants; |
| withdrawal of a product from the market; |
| costs to defend the related litigation; |
| substantial monetary awards to trial participants or patients; |
| loss of revenue; and |
| the inability to commercialize any products that we may develop. |
| a covered benefit under its health plan; |
| safe, effective and medically necessary; |
| appropriate for the specific patient; |
| cost-effective; and |
| neither experimental nor investigational. |
25
26
| termination of contracts; |
| forfeiture of profits; |
| suspension of payments; |
| fines; and |
| suspension or prohibition from doing business with the U.S. government. |
27
| the Federal Acquisition Regulations, and agency-specific regulations supplemental to the Federal Acquisition Regulations, which comprehensively regulate the procurement, formation, administration and performance of government contracts; |
| the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and Foreign Corrupt Practices Act; |
| export and import control laws and regulations; and |
| laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data. |
28
29
30
| restrictions on the marketing or manufacturing of a product; |
| warning letters; |
| withdrawal of the product from the market; |
| refusal to approve pending applications or supplements to approved applications; |
| voluntary or mandatory product recall; |
| fines or disgorgement of profits or revenue; |
| suspension or withdrawal of regulatory approvals, including license revocation; |
| refusal to permit the import or export of products; |
| product seizure; and |
| injunctions or the imposition of civil or criminal penalties. |
31
| our collaboration agreements are likely to be for fixed terms and subject to termination by our collaborators in the event of a material breach by us; |
| our collaborators are likely to have the first right to maintain or defend our intellectual property rights and, although we would have the right to assume the maintenance and defense of our intellectual property rights if our collaborators do not, our ability to do so may be compromised by our collaborators acts or omissions; and |
32
| our collaborators may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability. |
33
34
35
| we may be unable to license or acquire the relevant technology on terms that would allow us to make an appropriate return on the product; |
| companies that perceive us to be their competitor may be unwilling to assign or license their product rights to us; or |
| we may be unable to identify suitable products or product candidates within our areas of expertise. |
| use of cash resources; |
| higher than anticipated acquisition costs and expenses; |
| potentially dilutive issuances of equity securities; |
| the incurrence of debt and contingent liabilities, impairment losses or restructuring charges; |
| large write-offs and difficulties in assessing the relative percentages of in-process research and development expense that can be immediately written off as compared to the amount that must be amortized over the appropriate life of the asset; and |
| amortization expenses related to other intangible assets. |
| challenges associated with managing an increasingly diversified business; |
| disruption of our ongoing business; |
| difficulty and expense in assimilating the operations, products, technology, information systems or personnel of the acquired company; |
| diversion of managements time and attention from other business concerns; |
36
| inability to maintain uniform standards, controls, procedures and policies; |
| the assumption of known and unknown liabilities of the acquired company, including intellectual property claims; and |
| subsequent loss of key personnel. |
| the classification of our directors; |
| limitations on changing the number of directors then in office; |
| limitations on the removal of directors; |
| limitations on filling vacancies on the board; |
| limitations on the removal and appointment of the chairman of our board of directors; |
| following the second anniversary of the completion of this offering, advance notice requirements for stockholder nominations for election of directors and other proposals; |
| the inability of stockholders to act by written consent; |
37
| the inability of stockholders to call special meetings; and |
| the ability of our board of directors to designate the terms of and issue new series of preferred stock without stockholder approval. |
38
| the success of competitive products or technologies; |
| results of clinical trials of our product candidates or those of our competitors; |
| decisions and procurement policies by the U.S. government affecting BioThrax and our biodefense product candidates; |
| regulatory developments in the United States and foreign countries; |
| developments or disputes concerning patents or other proprietary rights; |
| the recruitment or departure of key personnel; |
| variations in our financial results or those of companies that are perceived to be similar to us; |
| market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts reports or recommendations; |
| general economic, industry and market conditions; and |
| the other factors described in this Risk factors section. |
39
40
| our performance under existing BioThrax sales contracts with HHS and DoD, including the timing of deliveries under these contracts; |
| our plans for future sales of BioThrax; |
| our plans to pursue label expansions and improvements for BioThrax; |
| our plans to expand our manufacturing facilities and capabilities; |
| the rate and degree of market acceptance and clinical utility of our products; |
| our ongoing and planned development programs, preclinical studies and clinical trials; |
| our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; |
| the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; |
| the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; |
| our commercialization, marketing and manufacturing capabilities and strategy; |
| our intellectual property portfolio; and |
| our estimates regarding expenses, future revenues, capital requirements and needs for additional financing. |
41
42
on an actual basis; and
on an as adjusted basis to give effect to:
the reclassification of our class A common stock as common
stock and the conversion of each outstanding share of our
class B common stock into one share of common stock prior
to the completion of this offering; and
the sale
of shares
of common stock that we are offering at an assumed initial
public offering price of
$ per share, which is the
midpoint of the price range set forth on the cover page of this
prospectus, after deducting estimated underwriting discounts and
commissions and offering expenses payable by us.
(1)
A $1.00 increase (decrease) in the assumed initial public
offering price of $ per share
would increase (decrease) each of additional paid-in capital,
total stockholders equity and total capitalization by
approximately $ million,
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same and after
deducting estimated underwriting discounts and commissions.
43
the incurrence of $8.5 million of indebtedness under a
mortgage loan from HSBC Realty Credit Corporation that we
entered into in April 2006 in connection with the purchase of a
building in Frederick, Maryland;
1,064,679 shares of common stock issuable upon the exercise
of stock options outstanding as of March 31, 2006 at a
weighted average exercise price of $5.16 per share;
168,521 additional shares of common stock reserved for issuance
under our employee stock option plan as of March 31,
2006; and
175,000 additional shares of common stock that will be reserved
for issuance under our 2006 stock incentive plan immediately
prior to completion of this offering.
44
$
$
7.07
$
Shares
purchased
Total
consideration
Average price
Number
Percentage
Amount
Percentage
per
share
7,768,801
%
$
34,715,125
%
$
4.47
100%
$
100%
$
45
1,064,679 shares of common stock issuable upon the exercise
of stock options outstanding as of March 31, 2006 at a
weighted average exercise price of $5.16 per share;
168,521 additional shares of common stock reserved for issuance
under our employee stock option plan as of March 31,
2006; and
175,000 additional shares of common stock that will be reserved
for issuance under our 2006 stock incentive plan immediately
prior to completion of this offering.
the number of shares of common stock held by existing
stockholders will decrease
to ,
or approximately % of the total number of shares of
our common stock outstanding after this offering; and
the number of shares of common stock held by new investors will
increase
to ,
or approximately % of the total number of shares of
our common stock outstanding after this offering.
46
Year ended
December 31,
Three months ended
March 31,
(in thousands,
except share and per share data)
2001
2002
2003
2004
2005
2005
2006
(unaudited)
$
45,309
$
78,541
$
55,536
$
81,014
$
127,271
$
14,782
$
12,196
233
2,480
3,417
480
27
45,309
78,541
55,769
83,494
130,688
15,262
12,223
34,367
24,569
22,342
30,102
31,603
4,136
2,861
382
2,808
6,327
10,117
18,381
1,852
8,173
10,924
13,397
19,547
30,323
42,793
8,849
10,587
1,824
26,575
(3,819
)
(10,000
)
45,673
40,774
50,040
66,723
109,352
14,837
21,621
(364
)
37,767
5,729
16,771
21,336
425
(9,398
)
122
80
100
65
485
77
203
(193
)
(451
)
(293
)
(241
)
(767
)
(189
)
(170
)
(119
)
(271
)
168
6
55
(13
)
7
(190
)
(642
)
(25
)
(170
)
(227
)
(125
)
40
(554
)
37,125
5,704
16,601
21,109
300
(9,358
)
733
1,250
5,129
5,325
76
(4,722
)
$
(554
)
$
36,392
$
4,454
$
11,472
$
15,784
$
224
$
(4,636
)
$
(0.10
)
$
5.68
$
0.68
$
1.74
$
2.21
$
0.03
$
(0.60
)
$
(0.10
)
$
5.05
$
0.63
$
1.61
$
2.00
$
0.03
$
(0.60
)
5,651,192
6,409,661
6,570,856
6,576,019
7,136,866
6,494,604
7,767,859
5,561,192
7,212,903
7,061,537
7,104,172
7,908,023
7,102,822
7,767,859
47
As of
December 31,
As of
(in
thousands)
2001
2002
2003
2004
2005
March 31,
2006
(unaudited)
$
5,854
$
4,891
$
7,119
$
6,821
$
36,294
$
14,774
(35,299
)
1,130
(3,147
)
7,509
29,023
20,048
25,423
22,790
37,127
69,056
100,332
90,573
4,857
4,592
1,228
11,921
10,502
10,225
(32,295
)
4,155
8,448
22,949
59,737
54,905
48
financial condition and results of operations
issued 6,487,950 shares of class A common stock in
exchange for 6,262,554 shares of BioPort class A
common stock and 225,396 shares of BioPort class B
common stock;
repurchased and retired all other issued and outstanding shares
of BioPort class B common stock; and
assumed all outstanding stock options to purchase BioPort
class B common stock and granted option holders replacement
stock options to purchase an equal number of shares of our
class B common stock.
49
50
there is persuasive evidence of an arrangement;
delivery has occurred or title has passed to our customer based
on contract terms;
the fee is fixed and determinable and no further obligation
exists; and
collectibility is reasonably assured.
51
52
fees payable to contract research organizations in conjunction
with clinical trials;
fees payable to third party manufacturers in conjunction with
the production of clinical trial materials; and
professional service fees.
53
54
the history and nature of our business and our growth
opportunities, including our contracts for BioThrax product
sales;
prior determinations of the fair value of the common stock
underlying stock options granted and the effect of corporate
developments, including the progress of our product candidates,
that have occurred between the time of the grants;
rights and preferences of the security being granted compared to
the rights and preferences of our other outstanding equity;
values of public companies that we believe are comparable to us,
adjusted for the risk and limited liquidity provided for in the
shares we are issuing;
the assessments provided by independent valuation specialists;
business developments involving our direct competitors; and
general economic trends and the economic outlook for our
industry.
55
56
salaries and related expenses for personnel;
fees to professional service providers for, among other things,
independently monitoring our clinical trials and acquiring and
evaluating data from our clinical trials;
57
costs of contract manufacturing services;
costs of materials used in clinical trials and research and
development;
depreciation of capital assets used to develop our
products; and
operating costs, such as the cost of facilities and the legal
costs of pursuing patent protection of our intellectual property.
the scope, rate of progress and expense of our clinical trials
and other research and development activities;
the potential benefits of our product candidates over other
products;
our ability to market, commercialize and achieve market
acceptance for any of our product candidates that we are
developing or may develop in the future;
future clinical trial results;
the terms and timing of regulatory approvals; and
the expense of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights.
58
59
60
Three months ended
March 31,
(in thousands)
2005
2006
$
432
$
1,364
558
2,733
186
497
47
497
1,223
5,091
605
638
997
91
442
269
91
2,951
538
131
$
1,852
$
8,173
61
62
Year ended
December 31,
(in
thousands)
2004
2005
$
5,929
$
2,883
350
5,309
1,708
427
6,279
10,327
1,477
1,558
2,433
1,136
837
656
1,136
6,961
2,702
1,093
$
10,117
$
18,381
63
64
65
Year ended
December 31,
Three months
ended March 31,
(in
thousands)
2003
2004
2005
2005
2006
$
11,072
$
9,196
$
41,974
$
(1,313
)
$
(18,277
)
(7,917
)
(18,175
)
(5,841
)
(379
)
(2,853
)
(927
)
8,681
(6,660
)
(138
)
(390
)
$
2,228
$
(298
)
$
29,473
$
(1,830
)
$
(21,520
)
(1)
66
67
Payments due by
period
(in
thousands)
Total
2006
2007
2008
2009
2010
After 2010
$
13,844
$
1,587
$
1,479
$
349
$
816
$
815
$
8,798
3,785
1,292
1,249
1,188
56
200
100
100
$
17,829
$
2,979
$
2,828
$
1,537
$
872
$
815
$
8,798
(1)
Does not include contingent royalties and milestone payments.
(2)
Includes scheduled interest payments, net of capitalization of
interest estimates related to construction in progress on long
term construction of fixed assets.
$2.5 million outstanding under a forgivable loan from the
Department of Business and Economic Development of the State of
Maryland used to finance eligible costs incurred to purchase one
of our facilities in Frederick, Maryland;
$7.0 million outstanding under a mortgage loan from
Mercantile Potomac Bank used to finance the remaining portion of
the purchase price for the Frederick facility;
$8.5 million outstanding under a mortgage loan from HSBC
Realty Credit Corporation used to finance the purchase price for
a second facility on the Frederick site; and
$1.4 million outstanding under a term loan from Fifth Third
Bank used to finance the purchase of an enterprise resource
planning system.
68
Under our mortgage loan from Mercantile Potomac Bank for our
Frederick facility, we are required to maintain at all times a
minimum tangible net worth, on a consolidated basis, of not less
than $5.0 million and a ratio of earnings before interest,
taxes, depreciation and amortization to the sum of current
obligations under capital leases and principal obligations and
interest expenses for borrowed money, in each case due and
payable within the following 12 months, of not less than
1.1 to 1.0.
Under our forgivable loan from the State of Maryland, we are not
required to repay the principal amount of the loan if beginning
December 31, 2009 and through 2012 we maintain a specified
number of employees at the Frederick site, by December 31,
2009 we have invested at least $42.9 million in total funds
toward financing the purchase of the buildings on the site and
for related improvements and operation of the facility and we
occupy the facility through 2012.
Under our line of credit with Fifth Third Bank, we are required
to maintain at all times a ratio of total liabilities to
tangible net worth of not more than 2.5 to 1.0.
69
the level of BioThrax product sales and cost of product sales;
the timing of, and the costs involved in, constructing our new
manufacturing facility in Lansing, Michigan and the build out of
our manufacturing facilities in Frederick, Maryland;
the scope, progress, results and costs of our preclinical and
clinical development activities;
the costs, timing and outcome of regulatory review of our
product candidates;
the number of, and development requirements for, other product
candidates that we may pursue;
the costs of commercialization activities, including product
marketing, sales and distribution;
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other patent-related
costs, including litigation costs and the results of such
litigation;
the extent to which we acquire or invest in businesses, products
and technologies; and
our ability to establish and maintain collaborations, such as
our collaboration with Sanofi Pasteur.
70
71
Anthrax immune globulin
for post-exposure
treatment of anthrax infection;
72
Botulinum immune globulin
for post-exposure
treatment of illness caused by botulinum toxin, which we are
developing based on a new botulinum toxoid vaccine that we are
developing in collaboration with the U.K. Health Protection
Agency, or HPA; and
Recombinant bivalent botulinum vaccine
a
prophylaxis for illness caused by botulinum toxin, which we also
are developing in collaboration with HPA.
Typhoid vaccine
a single dose, drinkable
vaccine, for which we have completed a Phase I clinical
program, including trials in the United States, the United
Kingdom and Vietnam, and expect to initiate a Phase II
clinical trial in Vietnam in the fourth quarter of 2006;
Hepatitis B therapeutic vaccine
a multiple
dose, drinkable vaccine for treatment of chronic carriers of
hepatitis B infection, for which we have completed a
Phase I clinical trial in the United Kingdom and expect to
initiate a Phase II clinical trial in the United Kingdom in
the second half of 2006; and
Group B streptococcus vaccine
a multiple
dose, injectable vaccine for administration to women of
childbearing age for protection of the fetus and newborn babies,
for which we have completed a Phase I clinical trial in the
United Kingdom.
73
74
75
the U.S. Postal Service;
foreign governments;
state and local governments, which we expect will be interested
in these products to protect first responders, such as police,
fire and emergency medical personnel;
multinational companies and non-governmental
organizations; and
hospitals.
76
77
78
*
We currently intend to rely on the
FDA animal rule in seeking marketing approval for these product
candidates. Under the animal rule, if human efficacy trials are
not ethical or feasible, the FDA can approve drugs or biologics
used to treat or prevent serious or life threatening conditions
caused by exposure to lethal or permanently disabling toxic
chemical, biological, radiological or nuclear substances based
on human clinical data demonstrating safety and immunogenicity
and evidence of efficacy from appropriate non-clinical animal
studies and any additional supporting data. For more information
about the FDA animal rule, see Government
regulation Clinical trials.
79
80
81
BioThrax is safe and effective;
the study used to support the original marketing approval of
BioThrax constituted a well controlled human efficacy study in
which BioThrax was 92.5% effective in preventing inhalational
and cutaneous anthrax;
as reported by the National Academy of Sciences Institute
of Medicine, studies in humans and animal models support the
conclusion that BioThrax is effective against anthrax strains
that are dependent upon the anthrax toxin as a mechanism of
virulence by all routes of exposure, including inhalation;
periodic evaluations of reports in the vaccine adverse event
reporting system database maintained by the CDC and the FDA
confirm that BioThrax continues to be safe for its intended use;
and
as reported by an independent advisory panel to the FDA, CDC
data suggest that BioThrax is fairly well tolerated with severe
local reactions and systemic reactions being relatively rare.
Extend shelf life.
In 2005, the FDA approved an
extension of BioThrax shelf life from two to three years, which
will allow BioThrax to be stockpiled for a longer period of
time. We are conducting ongoing stability testing of BioThrax,
and, depending on the outcome of these tests, we may apply for a
further extension of BioThrax shelf life to five years in 2007.
Reduce doses for pre-exposure prophylaxis.
Based on
an interim analysis of data from an ongoing clinical trial of
BioThrax being conducted by the CDC, we have applied to the FDA
to reduce the number of required doses of BioThrax for
pre-exposure prophylaxis from six to five, with an annual
booster dose thereafter. In April 2006, the FDA issued a
complete response letter to our application, requesting
clarification and requiring additional analysis of the data that
we submitted. We are in the process of responding to this letter
and amending our application.
Add second route of administration.
We have applied
to the FDA to add a second route of administration of BioThrax
to include intramuscular injection in addition to subcutaneous
injection. We
82
Single dose syringe.
We believe that products that
are administered in a single dose syringe are of significant
interest to HHS for inclusion in the strategic national
stockpile. As a result, we have initiated a development program
to make BioThrax available in single dose syringes.
shelf life of three years or longer at room temperature;
the ability to generate protective immune response in one or two
doses; and
the ability to be safely self administered or rapidly inoculated
into large numbers of people.
83
84
85
86
87
In
in vitro
tests in which human cells were exposed
to our vaccine candidate, the live attenuated bacteria contained
in the vaccine did not multiply.
In pharmacology studies in mice, our vaccine candidate was
immunogenic and had higher relative immunogenicity when
delivered subcutaneously than the currently approved oral
typhoid vaccine.
88
In safety and toxicity studies in mice, a strain of
Salmonella
that causes a disease similar to typhoid in
mice, which contained deletions of the genes that are also
deleted in our vaccine candidate, did not cause disease.
An open-label, non-placebo controlled, pilot study conducted in
the United Kingdom in nine healthy adult volunteers. The purpose
of this study was to evaluate the safety and immunogenicity of
our vaccine candidate. In this study, our vaccine candidate was
immunogenic, eliciting both cell mediated and humoral
immunogenicity, and well tolerated.
A double-blind, placebo controlled, single dose escalating
Phase I clinical trial conducted in the United States in 60
healthy adult volunteers. The purpose of this trial was to
evaluate the safety, tolerability and immunogenicity of three
dose levels of our vaccine candidate. In this trial, our vaccine
candidate was immunogenic and well tolerated at all dose levels.
An open-label, non-placebo controlled, single dose Phase I
clinical trial conducted in the United States in 32 healthy
adult volunteers. The purpose of this trial was to evaluate the
safety and immunogenicity of two different presentations of the
vaccine candidate, one using bottled water and another using tap
water. We vaccinated 16 subjects with each presentation. Because
one subject who received the tap water presentation of the
vaccine candidate was excluded from the trial results due to a
lack of post-baseline immunology data, the tap water
presentation data reflected data from only 15 subjects. More
than 90% of the subjects vaccinated with each presentation had a
humoral antibody response to
S. typhi
. Because the
two presentations were equally immunogenic and both were well
tolerated by trial participants, we selected the tap water
presentation for further development based on its relative
convenience.
Phase II clinical trial.
In the fourth quarter
of 2006, we plan to initiate a single-blind, placebo controlled
Phase II clinical trial in Vietnamese children between five
and 14 years of age. The Wellcome Trust has agreed to
provide funding for this trial. The purpose of this trial will
be to evaluate the safety and immunogenicity of our vaccine
candidate. The trial design calls for 100 subjects to receive
vaccine and 50 to receive placebo, with at least 70% of the
subjects being between five and ten years of age. We will assess
safety and immunogenicity up to 28 days after vaccination.
89
Disease surveillance study.
Concurrently with the
planned Phase II clinical trial, we plan to conduct a
disease surveillance study in the areas where we are considering
conducting a Phase III clinical trial of our vaccine
candidate in order to confirm that a sufficient number of
subjects will be included in the Phase III trial.
Phase III clinical trial.
We plan to conduct a
single-blind Phase III clinical trial in an area where
typhoid is endemic. The purpose of this trial will be to
evaluate the efficacy of our vaccine candidate in children who
are likely to be exposed to the typhoid bacterium. We expect to
undertake an interim analysis of the data from the trial after
approximately one year, which, if the results are favorable, we
plan to use to support the filing with the FDA of a BLA for
marketing approval of our vaccine candidate. We plan to continue
to monitor the incidence of typhoid in the trial participants
for several years after vaccination.
Tolerability and immunogenicity study.
Concurrently
with our Phase III clinical trial, we plan to conduct a
Phase III clinical trial in the United States or Europe in
healthy volunteers. The purpose of this trial will be to
evaluate the safety and immunogenicity of our vaccine candidate
in the target population to support marketing approval in the
United Sates and Europe.
90
91
92
In studies in rabbits and mice, the three protein components of
our vaccine candidate were immunogenic.
In a passive immunization study in which we administered rabbit
antibody to rat pups, the rat pups were protected against
challenge with disease.
Antibodies elicited by one of the protein components of our
vaccine candidate recognized a number of group B streptococcus
types, indicating that the protein component has potential to
generate immune responses with broad coverage.
In a toxicology study in mice with one of the protein components
of our vaccine candidate, the protein was non-toxic.
93
94
95
Approximate
Location
Use
Segment
square
feet
Owned/leased
Manufacturing operations facility
and office space
Biodefense
214,000
Owned
Future manufacturing facilities
Biodefense/
Commercial
290,000
Owned
Office and laboratory space
Biodefense/
36,000
Leases expire 2008
Commercial
Office space
Biodefense/
Commercial
23,000
Lease expires 2016
Office and laboratory space
Commercial
16,000
Leases expire 2016
96
97
98
the need for significant, long-term investment in research and
development;
the importance of manufacturing capacity, capability and
specialty know-how, such as techniques, processes and biological
starting materials; and
the high regulatory burden for prophylactic products, which
generally are administered to healthy people.
99
Anthrax immune globulin.
Cangene, in collaboration
with the CDC, is currently developing an anthrax immune globulin
using plasma collected from military personnel who have been
vaccinated with BioThrax. In July 2006, HHS exercised an option
under a modification to an existing development and supply
contract for Cangene to supply 10,000 doses of anthrax immune
globulin for the strategic national stockpile. In June 2006, HHS
awarded a contract to Human Genome Sciences to supply 20,000
treatment courses of a monoclonal antibody to
Bacillus
anthracis
, referred to as ABthrax, for the strategic
national stockpile.
Recombinant bivalent botulinum vaccine.
DynPort
Vaccine Company has a recombinant bivalent botulinum vaccine in
Phase I clinical development with funding from the DoD and
NIAID.
Botulinum immune globulin.
The current recommended
therapy for clinical symptoms of botulism following exposure
consists of passive immunization with an immune globulin
derivied from equine plasma. In June 2006, HHS awarded a
five-year development and supply contract to Cangene for a
heptavalent botulinum immune globulin derived from equine
plasma. The contract provides for the supply of 200,000 doses of
a botulinum immune globulin for the strategic national stockpile.
Typhoid vaccine.
One oral typhoid vaccine and one
injectable typhoid vaccine are currently approved and
administered in the United States and Europe. In addition,
combination vaccines are available for the prevention of
hepatitis A and typhoid infections. Antibiotics typically are
used to treat typhoid after infection. For more information, see
Products Commercial
business Typhoid vaccine. We believe that
Avant Immunotherapeutics Inc. has an oral, single dose, live
attenuated typhoid vaccine candidate in Phase I clinical
development with funding from the NIH.
Hepatitis B therapeutic vaccine.
There is no vaccine
currently on the market that is licensed for therapeutic use
for hepatitis B infection. Currently available therapies for
this patient population consist mainly of antiviral drugs, such
as an immunotherapy with interferons. For more information, see
Products Commercial
business Hepatitis B therapeutic vaccine.
Several other companies have
100
Group B streptococcus vaccine.
The existing method
of prevention of group B streptococcus infection in neonates is
the targeted administration of intravenous antibiotics to women
during labor. A number of competitors have passive immune
vaccines in preclinical development.
Chlamydia vaccine.
There is no vaccine currently on
the market for chlamydia, and we are not aware of any competing
chlamydia vaccine candidate in clinical development. Several
competitors may have chlamydia vaccine candidates in preclinical
development. Screening tests and effective antibiotic treatments
have been effective at containing chlamydia in the United States
and Europe.
Meningitis B vaccine.
Currently, there is no
meningitis vaccine on the market that is protective against
group B meningococcal infection. Novartis markets a meningitis B
vaccine in New Zealand to people under the age of 20 and is also
developing a broad coverage protein subunit vaccine candidate.
Current meningitis B treatment strategies include antibiotics
and clinical support.
Typhoid vaccine.
We hold five U.S. patents
relating to our typhoid vaccine candidate. Some of these patents
have claims to the composition of matter of the vaccine
candidate and methods of use of attenuated
Salmonella typhi
bacteria as vaccines for the treatment and prevention of
typhoid and for the delivery of vaccine antigens. In addition,
we have two pending U.S. patent applications with claims to
additional compositions and methods of therapy that are
generally related to our typhoid vaccine candidate. Our issued
U.S. patents expire, and, if issued, our U.S. patent
applications would expire, between 2015 and 2020. We hold 25
foreign counterparts to our issued U.S. patents relating to our
typhoid vaccine candidate, including counterparts under the
European Patent Convention and in Japan, that expire, and 31
foreign patent applications that, if issued, would expire,
between 2015 and 2020.
101
Hepatitis B therapeutic vaccine.
Our hepatitis B
therapeutic vaccine candidate uses our proprietary
spi
-VEC oral delivery system technology to deliver
hepatitis B core antigen to the human immune system.
Spi
-VEC is based on our live attenuated typhoid vaccine
candidate and employs recombinant technology to insert the gene
for hepatitis B core into the live attenuated S
almonella
bacteria. As a result, the patents relating to our typhoid
vaccine candidate also protect our hepatitis B therapeutic
vaccine candidate. We also hold one U.S. patent with claims
to the use of attenuated
Salmonella
organisms for the
delivery of hepatitis B vaccine antigens, which expires in 2019.
In addition, we have one pending U.S. patent application
relating to our hepatitis B therapeutic vaccine candidate, which
if issued also would expire in 2019. We have four foreign patent
applications relating to our hepatitis B therapeutic vaccine
candidate that, if issued, would expire in 2019.
Group B streptococcus vaccine.
We hold two
U.S. patents relating to our group B streptococcus vaccine
candidate with claims to the composition of matter of the
vaccine candidate and methods of use for the prevention or
treatment of infection caused by
Streptococcus
agalactiae
. In addition, we have four pending
U.S. patent applications with claims to additional
compositions and methods of therapy relating to our group B
streptococcus vaccine candidate. Our issued U.S. patents expire,
and, if issued, our U.S. patent applications would expire,
between 2019 and 2022. We hold 19 foreign counterparts to our
issued U.S. patents relating to our group B streptococcus
vaccine candidate, including counterparts under the European
Patent Convention and in Japan, that expire, and 39 foreign
patent applications that, if issued, would expire, in 2019.
STM technology.
We jointly own with Imperial College
Innovations Limited patents with claims to methods for the
identification of virulence genes using our signature tagged
mutagenesis, or STM, technology, which we used to identify and
develop the gene mutations that form the basis of our typhoid
vaccine and hepatitis B therapeutic vaccine candidates. We also
jointly own with Imperial Innovations the composition of matter
patents covering these gene mutations. We have exclusive rights,
even as to Imperial Innovations, under these jointly owned
patents in all fields of use, except in the field of diagnosis,
prevention, treatment, or palliation of microbial diseases,
disorders and infections in humans and animals where our rights
are generally non-exclusive and are subject to existing license
agreements with third parties. Because our typhoid vaccine and
hepatitis B therapeutic vaccine candidates are outside of this
non-exclusive field of use, we have exclusive rights with
respect to these vaccine candidates. We exclusively own the
composition of matter patents covering the specific combination
of mutations employed in our typhoid vaccine and hepatitis B
therapeutic vaccine candidates.
102
103
104
105
preclinical laboratory and animal tests;
submission to the FDA of an IND, which must become effective
before clinical trials may begin;
completion of human clinical trials and other studies to
establish the safety and efficacy of the proposed product for
each intended use;
FDA review of whether the facility in which the product is
manufactured, processed, packed or held complies with cGMP
requirements designed to assure the products continued
quality; and
submission to the FDA and approval of an NDA in the case of a
drug, or a BLA in the case of a biologic, containing preclinical
and clinical data, proposed labeling and information to
demonstrate that the product will be manufactured to appropriate
standards of identity, purity and quality.
In a Phase I clinical trial, the drug or biologic is
initially administered into healthy human subjects or subjects
with the target condition and tested for safety, dosage
tolerance, absorption, metabolism, distribution and excretion.
In a Phase II clinical trial, the drug or biologic is
administered to a limited subject population to identify
possible adverse effects and safety risks, the efficacy of the
product for specific targeted diseases and dosage tolerance and
optimal dosage.
A Phase III clinical trial is undertaken if a Phase II
clinical trial demonstrates that a dosage range of the drug or
biologic is effective and has an acceptable safety profile. In a
Phase III clinical trial, the drug or biologic is
administered to an expanded population, often at geographically
dispersed clinical trial sites, to further evaluate dosage and
clinical efficacy and to further test for safety.
106
107
recordkeeping requirements;
periodic reporting requirements;
cGMP requirements related to all stages of manufacturing,
testing, storage, packaging, labeling and distribution of
finished dosage forms of the product;
reporting of adverse experiences with the drug or
biologic; and
advertising and promotion restrictions.
108
restrictions on the marketing or manufacturing of a product;
warning letters;
withdrawal of the product from the market;
refusal to approve pending applications or supplements to
approved applications;
voluntary or mandatory product recall;
fines or disgorgement of profits or revenue;
suspension or withdrawal of regulatory approvals;
refusal to permit the import or export of products;
product seizure; and
injunctions or the imposition of civil or criminal penalties.
109
110
the agent for which the countermeasure is designed can cause
serious or life-threatening disease;
the product may reasonably be believed to be effective in
detecting, diagnosing, treating or preventing the disease;
the known and potential benefits of the product outweigh its
known and potential risks;
there is no adequate alternative to the product that is approved
and available; and
any other criteria prescribed in regulations are met.
111
112
113
114
develop and implement biosafety, security and emergency response
plans;
115
restrict access to select agents and toxins;
provide appropriate training to our employees for safety,
security and emergency response;
comply with strict requirements governing transfer of select
agents and toxins;
provide timely notice to the government of any theft, loss or
release of a select agent or toxin; and
maintain detailed records of information necessary to give a
complete accounting of all activities related to select agents
and toxins.
116
117
144
Name
Age
Position
48
55
49
49
51
44
53
54
62
54
39
50
72
(1)
Member of the Audit Committee.
(2)
Member of the Compensation Committee.
(3)
Member of the Nominating and Corporate Governance Committee.
118
119
120
,
and will serve as class I
directors, and their terms will expire at our 2007 annual
meeting;
and
will serve as class II directors, and their terms will
expire at our 2008 annual meeting; and
and
will serve as class III directors, and their terms will
expire at our 2009 annual meeting.
121
appointing, approving the compensation of, and assessing the
independence of our independent registered public accounting
firm;
overseeing the work of our independent registered public
accounting firm, including through the receipt and consideration
of reports from our independent registered public accounting
firm;
reviewing and discussing with management and the independent
registered public accounting firm our annual and quarterly
financial statements and related disclosures;
coordinating our board of directors oversight of internal
control over financial reporting, disclosure controls and
procedures and code of business conduct and ethics;
establishing procedures for the receipt and retention of
accounting related complaints and concerns;
meeting independently with our independent registered public
accounting firm and management; and
preparing the audit committee report required by Securities and
Exchange Commission rules.
122
reviewing and approving, or making recommendations to the board
of directors with respect to, the compensation of our chief
executive officer and our other executive officers;
overseeing the evaluation of the performance of our senior
executives;
overseeing and administering, and making recommendations to the
board of directors with respect to, our broad-based compensation
programs and our cash and equity incentive plans;
reviewing and making recommendations to the board of directors
with respect to director compensation; and
preparing the compensation committee report required by
Securities and Exchange Commission rules.
recommending to the board of directors the persons to be
nominated for election as directors or to fill vacancies and to
be appointed to each of the boards committees;
overseeing an annual review by the board of directors with
respect to management succession planning;
developing and recommending to the board of directors corporate
governance principles and guidelines; and
overseeing periodic evaluations of the board of directors.
123
On December 1, 2004, we granted a stock option to purchase
15,000 shares at an exercise price of $7.89 per share
to Dr. Harsanyi.
On January 26, 2005, we granted a stock option to purchase
15,000 shares at an exercise price of $7.89 per share
to Mr. Richard.
On June 15, 2005, we granted a stock option to purchase
15,000 shares at an exercise price of $10.06 per share
to Mr. Hauer.
On June 30, 2006, we granted a stock option to purchase
15,000 shares at an exercise price of $29.58 per share
to Dr. Sullivan.
On June 30, 2006, we granted a stock option to purchase
15,000 shares at an exercise price of $29.58 per share
to Mr. Allbaugh.
7,500 shares of common stock upon commencement of service
on our board of directors;
5,000 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six
months; and
if the non-employee director is serving as the chair of one or
more committees of our board of directors, an additional
2,500 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six months.
124
Long-term
compensation
Annual
compensation
Shares
Other annual
underlying
All other
Name and
principal position
Salary
Bonus(1)
compensation
options
compensation(2)
President, Chief Executive Officer and Chairman of the Board of
Directors
$
490,818
$
75,000
$
7,000
Executive Vice President and Chief Operating Officer
280,192
40,000
President and Chief Executive Officer, BioPort Corporation
371,192
40,000
7,000
President, Emergent Product Development UK Limited and Chief
Scientific Officer
225,162
38,752
(3)
20,000
Senior Vice President Corporate Affairs, General Counsel and
Secretary
272,631
(1)
Bonus amounts for 2005 have not yet been determined. Each of the
named executive officers is eligible to receive a bonus in an
amount determined by our board of directors.
(2)
Represents the value of our contributions on behalf of the named
executive officer to our 401(k) savings plan.
(3)
Represents a relocation payment of $15,000 and a living
allowance of $23,752.
125
Potential
realizable
Percentage of
value at
assumed
Number of
total options
annual rates
of
shares
granted to
Exercise
stock price
underlying
employees in
price per
Expiration
appreciation for
option term(1)
Name
options
granted
fiscal
year
share
date
5% ($)
10% ($)
75,000
(2)
30.0
%
$
10.06
5/25/10
40,000
(3)
16.0
7.89
2/9/10
40,000
(2)
16.0
10.06
5/25/10
20,000
(3)
8.0
7.89
2/9/10
(1)
The dollar amounts under these columns are the result of
calculations at rates set by the Securities and Exchange
Commission and, therefore, are not intended to forecast possible
future appreciation, if any, in the price of the underlying
common stock.
(2)
These options vest in three annual installments, with 40% of the
original number of shares having vested on December 31,
2005 and 30% of the original number of shares vesting on each of
December 31, 2006 and December 31, 2007.
(3)
These options vest in three equal annual installments beginning
on December 31, 2005.
126
fiscal year-end option values
Number of
securities
underlying
unexercised
Value of
unexercised
Number of
shares
options at
in-the-money
options at
acquired on
Value
December 31,
2005
December 31,
2005
Name
exercise
realized
Exercisable
Unexercisable
Exercisable
Unexercisable
30,000
45,000
13,334
26,666
178,500
24,000
6,667
13,333
25,900
11,100
127
any unpaid base salary and accrued paid time-off through the
date of termination;
a pro rata target annual bonus in respect of the year of
termination;
any bonus earned but unpaid as of the date of termination for
any previously completed year;
reimbursement for any unreimbursed expenses incurred by the
participant prior to the date of termination;
an amount equal to a specified percentage of the
participants annual base salary;
employee and fringe benefits and perquisites, if any, to which
the participant may be entitled as of the date of termination
under our relevant plans, policies and programs; and
continued eligibility for the participant and his or her
eligible dependents to receive employee benefits, for a stated
period following the participants date of termination,
except when the provision of employee benefits would result in a
duplication of benefits provided by any subsequent employer.
128
Stated period
Percentage of
for continued
annual base
employee
Name
salary
benefits
150
%
18 months
100
12 months
100
12 months
100
12 months
100
12 months
75
9 months
for the same stated period during which we have agreed to
provide continued employee benefits to the terminated employee,
not to:
induce, counsel, advise, solicit or encourage our employees to
leave our employ or to accept employment with any other person
or entity,
induce, counsel, advise, solicit or encourage any person who we
employed within six months prior to that time to accept
employment with any person or entity besides us or hire or
engage that person as an independent contractor,
solicit, interfere with or endeavor to cause any of our
customers, clients or business partners to cease or reduce its
relationship with us or induce any such customer, client or
business partner to breach any agreement that such customer,
client or business partner may have with us, and
engage in or have a financial interest in any business competing
with us within any state, region or locality in which we are
then doing business or marketing products;
upon reasonable notice and at our expense, to cooperate fully
with any reasonable request that may be made by us in connection
with any investigation, litigation or other similar activity to
which we are or may be a party or may otherwise be involved and
for which the participant may have relevant information; and
to sign and deliver a suitable waiver and release under which
the participant will release and discharge us from and on
account of any and all claims that relate to or arise out of our
employment relationship.
129
Mr. El-Hibris service as chairman of Digicel
Holdings, chairman of East West Resources, a member of the board
of trustees of American University, a member of the board of
directors of the International Biomedical Research Alliance and
director and treasurer of El-Hibri Charitable Foundation and his
management of his personal investments at levels of time and
attention comparable to those that Mr. El-Hibri provided to
such entities within the preceding twelve months, do not violate
his contractual obligations to us or interfere with his ability
to perform his duties to us;
it is not a violation of
Mr. El-Hibris
contractual obligations to us if he pursues a business
transaction or opportunity where such transaction or opportunity
was first presented to
Mr. El-Hibri
in his capacity as an officer or director of the entities listed
above or where such transaction or opportunity was first
presented to us and our board of directors declined to pursue
such transaction or opportunity; and
with respect to three employees who, at
Mr. El-Hibris
invitation, left their employment with East West Resources to
accept employment with us, it is not a violation of
Mr. El-Hibris
non-solicitation agreement to induce, counsel, advise, solicit
or encourage, or attempt to induce, counsel, advise, solicit or
encourage those employees to return to employment with East West
Resources.
a lump sum amount, payable within 30 days following the
date of termination, equal to the sum of:
any unpaid base salary and accrued paid time-off through the
date of termination,
a pro rata target annual bonus in respect of the year of
termination,
any bonus earned but unpaid as of the date of termination for
any previously completed year,
any unreimbursed expenses incurred by the participant prior to
the date of termination, and
an amount equal to a specified percentage of the sum of the
participants base salary and the greater of the annual
bonus that was paid to the participant in respect of the most
recently completed year or the maximum annual bonus that could
have been paid to the participant under an established bonus
plan for the most recently completed year;
employee and fringe benefits and perquisites, if any, to which
the participant may be entitled as of the date of termination of
employment under our relevant plans, policies and programs;
any unvested stock options held by the participant that are
outstanding on the date of termination will become fully vested
as of that date, and the period, during which any stock options
held by the participant that are outstanding on that date may be
exercised, shall be extended to a date that is the later of the
15th day of the third month following the termination date,
or December 31 of the
130
calendar year in which the stock option would otherwise have
expired if the exercise period had not been extended, but not
beyond the final date the stock option could have been exercised
if the participants employment had not terminated, in each
case based on the term of the option at the original grant date;
continued eligibility for the participant and his or her
eligible dependents to receive employee benefits, for a stated
period following the participants date of termination,
except when the provision of employee benefits would result in a
duplication of benefits provided by any subsequent employer;
a
gross-up
payment with respect to applicable taxes on any payment to the
participant;
the retention for the maximum period permitted by applicable law
of all rights the participant has to indemnification from us
immediately prior to the change of control and the continuation
throughout the period of any applicable statute of limitations
of any directors and officers liability insurance
covering the participant immediately prior to the change of
control; and
the advancement to the participant of all costs and expenses,
including attorneys fees and disbursements, incurred by
the participant in connection with any legal proceedings that
relate to the termination of employment or the interpretation or
enforcement of any provision of the severance plan, for which
the participant will have no obligation to reimburse us if the
participant prevails in the proceeding with respect to at least
one material issue or the proceeding is settled.
Stated period
Percentage of
for continued
annual base
employee
Name
salary
benefits
250
%
30 months
200
24 months
200
24 months
150
18 months
100
12 months
75
9 months
131
for any breach of their duty of loyalty to us or our
stockholders;
for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law;
for voting or assenting to unlawful payments of dividends or
other distributions; or
for any transaction from which the director derived an improper
personal benefit.
132
133
Maximum
Maximum
specified
specified
percentage of
number of
outstanding
shares
shares
149,000
1.5
%
161,000
1.5
322,000
3.0
162,000
1.5
326,000
3.0
164,000
1.5
the number of shares of common stock covered by options and the
dates upon which the options become exercisable;
the exercise price of options, which may not be less than 100%
of the fair market value of the stock on the date of grant;
the duration of options, which may not be in excess of
10 years;
the method of payment of the exercise price; and
the number of shares of common stock subject to any stock
appreciation right, restricted stock, restricted stock units or
other stock-unit awards and the terms and conditions of such
awards, including conditions for exercise, repurchase, issue
price and repurchase price.
134
7,500 shares of common stock, upon the commencement of
service on our board of directors;
5,000 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six
months; and
if the non-employee director is serving as the chair of one or
more committees of our board of directors, an additional
2,500 shares of common stock, on the date of each of our
annual meetings of stockholders, provided that the director
continues serving as a director after the annual meeting and has
served on our board of directors for at least six months.
have an exercise price equal to the closing sale price of the
common stock on the Nasdaq Stock Market or the national
securities exchange on which the common stock is then traded on
the trading date immediately prior to the date of grant, or the
fair market value of the common stock on such date as determined
by our board of directors, if the common stock is not then
traded on The Nasdaq Stock Market or on a national securities
exchange;
vest in three equal annual installments beginning on the
anniversary of the date of grant provided that the individual is
serving on our board of directors on such date, or, with respect
to annual grants, on the date which is one business day prior to
the date of our next annual meeting, if earlier, provided that
no additional vesting will take place after the individual
ceases to serve as a director and that our board of directors
may provide for accelerated vesting in the case of death,
disability, attainment of mandatory retirement age or retirement
following at least 10 years of service;
expire on the earlier of 10 years from the date of grant or
three months following cessation of service on our board of
directors; and
contain other terms and conditions as our board of directors
determines.
135
136
Emergent BioSolutions Inc., a newly formed Delaware corporation,
issued 6,487,950 shares of class A common stock to
stockholders of BioPort Corporation in exchange for
6,262,554 shares of BioPort class A common stock and
225,396 shares of BioPort class B common stock;
we repurchased and retired all other issued and outstanding
shares of BioPort class B common stock; and
we assumed all outstanding stock options to purchase BioPort
class B common stock and granted option holders replacement
stock options to purchase an equal number of shares of our
class B common stock under our employee stock option plan.
Number of shares
of
Name
class A
common stock
2,890,000
1,412,896
672,500
555,822
477,941
250,000
228,791
137
Number of shares
of
class B
common stock
underlying
options
Name
granted
162,500
37,000
15,000
Amount of
special
Name
cash
dividend
$
2,402,864
1,174,739
559,144
462,133
397,380
207,860
190,226
138
Number of shares
of
Name
common
stock
2,890,000
1,412,896
1,264,051
672,500
555,822
477,941
250,000
228,791
139
140
payment of any previously unpaid base salary and accrued paid
time off and other benefits through the date of termination;
141
payment of any unpaid, pro-rated bonus through the date of
termination; and
a lump sum payment in the amount of $100,000, less applicable
withholding and related taxes.
142
each of our named executive officers;
each of our directors;
all of our directors and executive officers as a group; and
each person, or group of affiliated persons, who is known by us
to beneficially own more than 5% of our common stock.
143
Percentage of
shares
Number of
shares
beneficially
owned
Name of
beneficial owner
beneficially
owned
Before
offering
After
offering
7,782,001
99.6
%
13,334
*
178,500
2.2
6,667
*
25,900
*
10,000
*
5,000
*
5,000
*
8,038,902
99.6
7,752,001
99.6
1,264,051
16.2
832,104
10.5
502,941
6.4
*
Less than 1%.
(1)
Consists of the following shares of our common stock:
If the underwriters exercise their over-allotment option in
full, Mr. El-Hibri will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Robert Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mauro and Yasmine Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika.
Janice Mugrditchian has the power to dispose of all shares of
our capital stock held by ARPI.
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments and share
the power to vote these shares with BioPharm, L.L.C.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(2)
Consists of 13,334 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(3)
Consists of 178,500 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(4)
Consists of 6,667 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(5)
Consists of 25,900 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(6)
Consists of 10,000 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(7)
Consists of 5,000 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(8)
Consists of 5,000 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(9)
Consists of 286,901 shares of common stock subject to stock
options exercisable within 60 days of July 31, 2006.
(10)
Consists of the following shares of our common stock:
145
If the underwriters exercise their over-allotment option in
full, these stockholders will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Intervac, BioPharm, Michigan Biologics Products, Biovac,
Biologika, Intervac Management and ARPI are parties to a voting
agreement dated June 30, 2004. BioPharm also is a party to
separate voting agreements with Michigan Biologics Products,
Biologika and Microscience Investments.
Robert Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mauro and Yasmine Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika.
Janice Mugrditchian has the power to dispose of all shares of
our capital stock held by ARPI.
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(11)
The holders of series B preferred ordinary shares of
Microscience Investments have the power to dispose of all shares
of our capital stock held by Microscience Investments and share
the power to vote these shares with BioPharm, L.L.C. Investment
funds affiliated with Apax Funds Nominees Limited, Advent
Private Equity Funds, JP Morgan Partners LLC and The Merlin
Biosciences Funds are the holders of the Microscience
Investments series B preferred ordinary shares. No holder
or group of affiliated holders of series B preferred
ordinary shares of Microscience Investments alone has the power
to direct the disposition of the shares of our capital stock
held by Microscience Investments. Microscience Investments is a
party to a voting agreement with BioPharm, L.L.C. For more
information regarding this voting agreement, see
Stockholder arrangements below.
(12)
Consists of the following shares of our common stock:
146
If the underwriters exercise their over-allotment option in
full, Dr. Myers will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Dr. Myers has the power to direct the disposition of all
shares of our capital stock held by Michigan Biologics Products.
Mr. El-Hibri has the power to direct the voting of all
shares of our capital stock held by Michigan Biologics Products.
For more information regarding the beneficial ownership of these
shares, see Stockholder arrangements
below.
(13)
Consists of the following shares of our common stock:
If the underwriters exercise their over-allotment option in
full, Mr. and Mrs. Gibellini will beneficially
own shares
of our common stock after this offering, or % of our
outstanding common stock, consisting of the following shares of
our common stock:
Mr. and Mrs. Gibellini, as tenants by the entirety, have
the power to dispose of all shares of our capital stock held by
Biologika. Mr. El-Hibri has the power to direct the voting
of all shares of our capital stock held by Biologika. For more
information regarding the beneficial ownership of these shares,
see Stockholder arrangements below.
Number of shares
of
Name
common
stock
147
148
149
our class A common stock will be reclassified as common
stock and each outstanding share of our class B common
stock will be converted into one share of common stock; and
each outstanding option to purchase shares of our class B
common stock will automatically become an option to purchase an
equal number of shares of common stock at the same exercise
price per share.
150
151
152
the rights are evidenced by our common stock certificates and
will be transferred with and only with such common stock
certificates; and
the surrender for transfer of any certificates of our common
stock will also constitute the transfer of the rights associated
with our common stock represented by such certificate.
10 business days following the later of (1) a public
announcement that a person or group, other than an exempted
person, has acquired, or obtained the right to acquire
beneficial ownership of 15% or more of the outstanding shares of
our common stock or (2) the first date on which one of our
executive officers has actual knowledge of such an
event; and
153
10 business days following the start of a tender offer or
exchange offer that would result in a person or group, other
than an exempted person, beneficially owning 15% or more of the
outstanding shares of our common stock.
Fuad El-Hibri;
Microscience Investments Limited, unless and until such time as
Microscience, together with its affiliates and associates,
directly or indirectly, becomes the beneficial owner of any
additional shares of common stock, except under certain
specified circumstances, and disregarding any shares
Microscience is or becomes the beneficial owner of solely as a
result of the fact that it is a party to any of the voting
agreements described under Principal and selling
stockholders Stockholder arrangements; and
each other holder of our class A common stock immediately
prior to this offering to the extent such persons
beneficial ownership exceeds 15% solely as a result of the fact
that the person is a party to any of the voting agreements
described under Principal and selling
stockholders Stockholder arrangements.
rights will not be exercisable until the rights are no longer
redeemable by us as set forth below; and
all rights that are, or were, under the circumstances specified
in the rights agreement, beneficially owned by any acquiring
person will be null and void.
we are acquired in a merger or other business combination
transaction in which we are not the surviving corporation;
154
we are the surviving entity in a merger of other business
combination transaction but our common stock is changed or
exchanged for stock or securities of any other person or for
cash or any other property; or
50% or more of our assets or earning power is sold or
transferred,
155
156
157
1% of the number of shares of our common stock then outstanding,
which will equal
approximately shares
immediately after this offering; and
the average weekly trading volume in our common stock on The
NASDAQ Global Market during the four calendar weeks preceding
the date of filing of a Notice of Proposed Sale of Securities
Pursuant to Rule 144 with respect to the sale.
the person is not our affiliate and has not been our affiliate
at any time during the three months preceding the sale; and
158
the person has beneficially owned the shares proposed to be sold
for at least two years, including the holding period of any
prior owner other than an affiliate.
159
Number of
Name
shares
Without over-
With full
over-
Underwriting
discounts and commissions
allotment
exercise
allotment
exercise
$
$
$
$
160
161
162
the information set forth in this prospectus and otherwise
available to the representatives;
our prospects and the history and prospects for the industry in
which we compete;
an assessment of our management;
our prospects for future earnings;
the general condition of the securities markets at the time of
this offering;
the recent market prices of, and demand for, publicly traded
common stock of generally comparable companies; and
other factors deemed relevant by the underwriters and us.
163
164
F-23
F-28
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-1
F-2
Consolidated balance sheets
F-3
Consolidated statements of operations
Three months
ended
March 31,
(in
thousands, except
Year
ended December 31,
(unaudited)
share and per
share data)
2003
2004
2005
2005
2006
$
55,536
$
81,014
$
127,271
$
14,782
$
12,196
233
2,480
3,417
480
27
55,769
83,494
130,688
15,262
12,223
22,342
30,102
31,603
4,136
2,861
6,327
10,117
18,381
1,852
8,173
19,547
30,323
42,793
8,849
10,587
1,824
26,575
(3,819
)
(10,000
)
5,729
16,771
21,336
425
(9,398
)
100
65
485
77
203
(293
)
(241
)
(767
)
(189
)
(170
)
168
6
55
(13
)
7
(25
)
(170
)
(227
)
(125
)
40
5,704
16,601
21,109
300
(9,358
)
1,250
5,129
5,325
76
(4,722
)
$
4,454
$
11,472
$
15,784
$
224
$
(4,636
)
$
0.68
$
1.74
$
2.21
$
0.03
$
(0.60
)
$
0.63
$
1.61
$
2.00
$
0.03
$
(0.60
)
6,570,856
6,576,019
7,136,866
6,494,604
7,767,859
7,061,537
7,104,172
7,908,023
7,102,822
7,767,859
$
$
$
0.76
$
$
F-4
Consolidated statement of changes in
stockholders equity
Class A
Class B
Accumulated
no-par
no-par
Class A
Class B
Additional
other
Total
(in thousands,
except
common
stock
common stock
$0.01 par
value common stock
$0.01 par
value common stock
paid-in
Retained
comprehensive
stockholders
share and per
share data)
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
capital
earnings
loss
equity
6,262,554
$
2,940
$
254,384
$
69
$
$
$
$
1,146
$
$
4,155
(25,000
)
(7
)
(193
)
(200
)
152,676
39
39
4,454
4,454
6,262,554
2,940
382,060
101
5,407
8,448
(199,271
)
(53
)
(1,559
)
(1,612
)
42,607
12
12
(6,262,554
)
(2,940
)
6,262,554
63
2,877
(225,396
)
(60
)
225,396
2
58
4,310
4,310
319
319
11,472
11,472
6,487,950
65
7,564
15,320
22,949
1,264,051
13
26,988
27,001
46,384
33
33
(38,984
)
(29
)
(308
)
(337
)
(17
)
(17
)
(5,400
)
(5,400
)
15,784
15,784
(276
)
(276
)
15,508
7,752,001
78
7,400
34,539
25,396
(276
)
59,737
(200
)
(200
)
9,400
2
2
96
96
(4,636
)
(4,636
)
(94
)
(94
)
(4,730
)
$
$
7,752,001
$
78
16,800
$
$
34,637
$
20,560
$
(370
)
$
54,905
F-5
Consolidated statements of cash flows
Three months
ended
March 31,
Year ended
December 31,
(unaudited)
(in
thousands)
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
224
$
(4,636
)
4,310
(17
)
96
(3,819
)
1,214
1,867
3,549
841
968
(467
)
(418
)
(10,968
)
96
635
200
13
43
32
15
4
1,824
26,575
540
(528
)
(15,664
)
16,107
13,625
59
(4,656
)
(1,609
)
(3,189
)
(4,318
)
(4,661
)
(1,713
)
5,794
(2,390
)
(444
)
(6,615
)
(244
)
50
(865
)
(181
)
(1,404
)
983
2,472
5,463
(456
)
(2,294
)
(583
)
585
2,466
88
(472
)
(1,617
)
44
619
113
137
11,852
3,869
(10,916
)
(10,916
)
11,072
9,196
42,250
(1,313
)
(18,183
)
(4,123
)
(17,072
)
(6,532
)
(379
)
(2,853
)
(3,794
)
(559
)
(1,250
)
1,250
147
(7,917
)
(18,175
)
(5,841
)
(379
)
(2,853
)
172
10,992
31
70
947
123
(900
)
(2,351
)
39
12
33
2
(200
)
(665
)
(337
)
(106
)
(200
)
(38
)
(184
)
(1,110
)
(102
)
(192
)
(70
)
(5,400
)
(927
)
8,681
(6,660
)
(138
)
(390
)
(276
)
(94
)
2,228
(298
)
29,473
(1,830
)
(21,520
)
4,891
7,119
6,821
6,821
36,294
$
7,119
$
6,821
$
36,294
$
4,991
$
14,774
$
99
$
170
$
696
$
144
$
148
$
4,280
$
$
17,985
$
500
$
1,200
$
$
$
27,001
$
$
F-6
Notes to consolidated financial statements
(dollars in thousands, except per
share data)
1.
Nature of the
business and organization
Emergent issued 6,487,950 shares of Class A Common
Stock in exchange for 6,262,554 shares of BioPort
class A common stock and 225,396 shares of BioPort
class B common stock;
all other issued and outstanding shares of BioPort class B
common stock were repurchased and retired; and
all outstanding stock options to purchase BioPort class B
common stock were assumed by Emergent and option holders were
granted replacement stock options to purchase an equal number of
shares of Class B Common Stock of Emergent.
2.
Summary of
significant accounting policies
F-7
F-8
39 years
3-7 years
Lesser of 3 years or product life
Lesser of the asset life or life of lease
F-9
there is persuasive evidence of an arrangement;
delivery has occurred and title has passed to the Companys
customer;
the fee is fixed and determinable and no further obligation
exists; and
collectibility is reasonably assured.
F-10
F-11
Year ended
December 31,
Three months
ended March 31,
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
224
$
(4,636
)
6,570,856
6,576,019
7,136,866
6,494,604
7,767,859
490,681
528,152
771,157
608,218
7,061,537
7,104,172
7,908,023
7,102,822
7,767,859
$
0.68
$
1.74
$
2.21
$
0.03
$
(0.60
)
$
0.63
$
1.61
$
2.00
$
0.03
$
(0.60
)
F-12
Year ended
December 31,
Three months
ended March 31,
2003
2004
2005
2005
2006
0
%
0
%
0
%
0
%
100
%
52
%
50
%
50
%
3.15
%
2.93
%
3.68
%
3.44
%
2.7
2.5
3.4
3.5
0
%
0
%
0
%
0
%
Expected dividend yield
The Company does not
pay regular dividends on its common stock and does not
anticipate paying any dividends in the foreseeable future.
F-13
Expected volatility
Volatility is a measure
of the amount by which a financial variable, such as share
price, has fluctuated (historical volatility) or is expected to
fluctuate (expected volatility) during a period. The Company
uses the historical volatility of similar companies over the
preceding three-year period to estimate expected volatility.
Since 2003, the annual volatility of these similar companies has
ranged from 18.4% to 29.4%, with an average of 23.4%.
Risk-free interest rate
This is the average
U.S. Treasury rate with a term that most closely resembles
the expected life of the option for the quarter in which the
option was granted.
Expected average life of options
This is the
period of time that the options granted are expected to remain
outstanding. This estimate is based primarily on the employee
position profile of option holders and the trading lock out
periods that result from the employees access to stock price
sensitive information.
Forfeiture rate
This is the estimated
percentage of options granted that are expected to be forfeited
or cancelled on an annual basis before becoming fully vested.
The Company estimates the forfeiture rate based on past turnover
data with further consideration given to the level of the
employees to whom the options were granted.
Year ended
December 31,
Three months
ended March 31,
2003
2004
2005
2005
2006
$
4,454
$
11,472
$
15,784
$
224
$
(4,636
)
2,801
96
(133
)
(3,185
)
(258
)
(32
)
(96
)
$
4,321
$
11,088
$
15,526
$
192
$
(4,636
)
$
0.68
$
1.74
$
2.21
$
0.03
$
(0.60
)
$
0.63
$
1.61
$
2.00
$
0.03
$
(0.60
)
$
0.66
$
1.69
$
2.18
$
0.03
$
(0.60
)
$
0.61
$
1.56
$
1.96
$
0.03
$
(0.60
)
F-14
3.
Acquisitions
F-15
$
27,001
1,194
$
28,195
$
1,441
863
(684
)
1,620
26,575
$
28,195
Year ended
December 31,
2004
2005
$
83,571
$
131,411
$
(5,243
)
$
10,875
$
(0.80
)
$
1.52
$
(0.80
)
$
1.38
F-16
$
3,400
394
$
3,794
$
279
1,691
1,824
$
3,794
4.
Accounts
receivable
December 31,
March 31,
2004
2005
2006
$
14,865
$
1,112
$
780
3,772
1,418
1,690
$
18,637
$
2,530
$
2,470
F-17
5.
Inventories
December 31,
March 31,
2004
2005
2006
$
1,947
$
2,229
$
2,245
6,674
9,547
17,124
4,632
4,665
1,733
$
13,253
$
16,441
$
21,102
6.
Property, plant
and equipment
December 31,
March 31,
2004
2005
2006
$
2,963
$
2,995
$
2,998
13,496
14,143
14,340
10,563
12,520
13,635
3,818
3,937
4,208
2,086
6,197
7,467
32,925
39,792
42,648
(5,657
)
(9,147
)
(10,121
)
$
27,269
$
30,645
$
32,527
7.
Other
assets
F-18
8.
Other current
liabilities
December 31,
March 31,
2004
2005
2006
$
3
$
445
$
1,072
1,462
1,390
1,089
71
146
168
357
628
417
$
1,893
$
2,609
$
2,746
9.
Long-term debt
and related party notes payable
2004
2005
2006
$
7,000
$
7,000
$
7,000
2,500
2,500
2,500
2,280
1,760
1,600
947
537
520
140
113
98
12,867
11,909
11,718
(1,046
)
(1,408
)
(1,493
)
$
11,821
$
10,502
$
10,225
F-19
$
1,408
1,302
317
2,838
6,045
$
11,910
10.
Stockholders
equity
F-20
F-21
BioPort
Plan
Emergent
Plan
Weighted
Weighted
average
average
Aggregate
Number
exercise
Number
exercise
intrinsic
of
shares
price
of
shares
price
value
Outstanding at December 31,
2002
803,242
$
0.25
$
103,500
13.05
(152,676
)
0.26
(77,235
)
0.80
676,831
2.17
458,696
0.58
47,391
3.11
281,898
7.89
(42,607
)
0.27
(677,381
)
1.24
677,381
1.24
(4,234
)
1.36
(57,784
)
3.44
901,495
$
3.27
860,279
2.95
280,000
11.19
(46,384
)
0.91
(43,032
)
7.57
1,092,079
$
5.11
852,481
$
3.50
(9,400
)
0.25
F-22
BioPort
Plan
Emergent
Plan
Weighted
Weighted
average
average
Aggregate
Number
exercise
Number
exercise
intrinsic
of
shares
price
of
shares
price
value
(18,000
)
4.70
1,064,679
$
5.16
$
20,612,185
836,081
$
3.70
$
17,407,206
Options
outstanding
Options
exercisable
Weighted
average
Weighted
Weighted
remaining
average
average
Range
of
Number
contractual
exercise
Number
exercise
exercise
prices
outstanding
life
(years)
price
exercisable
price
$ 0.25
342,879
1.50
$
0.25
342,879
$
0.25
162,500
1.50
0.28
162,500
0.28
16,100
1.50
4.43
16,100
4.43
400,600
2.69
7.89
279,002
7.89
135,000
4.96
10.06
48,000
10.06
35,000
4.65
24.52
4,000
24.52
1,092,079
2.46
$
5.11
852,481
$
3.50
Weighted
Weighted
Weighted
Number of
average
average
average
options
exercise
fair value of
intrinsic
Month
of grant
granted
price
common stock
value(1)
April 2005
25,000
$
7.89
$
7.89
115,000
10.06
10.06
30,000
14.88
14.88
10,000
24.52
24.52
5,000
24.52
24.52
10,000
24.52
24.52
(1)
Intrinsic value reflects the amount by which the value of the
shares as of the grant date exceeds the exercise price of the
options.
11.
Income
taxes
Three months
Year ended
December 31,
ended
March 31,
2003
2004
2005
2005
2006
Current
$
1,717
$
5,547
$
16,093
$
(20
)
$
(5,155
)
200
100
1,717
5,547
16,293
(20
)
(5,055
)
(416
)
(372
)
(9,769
)
(39
)
301
(51
)
(46
)
(1,199
)
135
32
(467
)
(418
)
(10,968
)
96
333
$
1,250
$
5,129
$
5,325
$
76
$
(4,722
)
F-24
December 31,
March 31,
2004
2005
2006
Net operating loss carryforward
$
666
$
2,242
$
2,901
645
721
1,457
1,696
1,689
10,114
9,666
883
3,198
5,080
3,651
17,971
19,336
(1,859
)
(1,387
)
(1,238
)
(124
)
(393
)
(609
)
(1,983
)
(1,780
)
(1,847
)
(666
)
(4,221
)
(6,154
)
$
1,002
$
11,970
$
11,335
Year ended
December 31,
Three months
ended March 31,
2003
2004
2005
2005
2006
Federal tax at statutory rates
$
1,996
$
5,863
$
7,388
$
105
$
(3,181
)
(230
)
(714
)
(2,329
)
(160
)
(27
)
Impact of foreign operations
(2,278
)
(1,467
)
Change in valuation allowance
187
479
3,558
237
1,915
Tax credits
(441
)
(492
)
(474
)
(120
)
Other differences
(255
)
11
(214
)
80
(1,993
)
Permanent differences
(7
)
(18
)
(326
)
(66
)
31
Federal tax at statutory rates
$
1,250
$
5,129
$
5,325
$
76
$
(4,722
)
12.
401(k) savings
plan
F-25
13.
Commitments and
settlement gains
$
1,689
2007
1,249
2008
1,188
2009
56
Total minimum lease payments
$
4,182
F-26
15.
Segment
information
Reportable
segments
Biodefense
Commercial
All
other
Total
$
128,219
$
2,469
$
$
130,688
10,327
6,962
1,092
18,381
485
485
(767
)
(767
)
2,911
411
226
3,548
58,632
(40,325
)
2,523
15,784
40,502
5,489
54,341
100,332
$
3,286
$
3,052
$
194
$
6,532
F-27
Reportable
segments
Biodefense
Commercial
All
other
Total
$
82,585
$
909
$
$
83,494
6,279
1,136
2,702
10,117
65
65
(241
)
(241
)
1,685
169
10
1,867
21,776
(5,428
)
(4,876
)
11,472
51,626
3,491
13,939
69,056
$
8,320
$
668
$
8,084
$
17,072
$
55,536
$
233
$
$
55,769
4,352
477
1,498
6,327
100
100
(293
)
(293
)
1,153
61
6,106
(1,459
)
(193
)
(4,454
)
28,266
2,462
7,119
37,847
$
4,020
$
103
$
$
4,123
16.
Quarterly
financial data (unaudited)
Three months
ended
March 31
June 30
September 30
December 31
$
15,261
$
44,058
$
27,581
$
43,788
425
3,699
4,498
12,714
225
2,616
3,410
9,533
0.03
0.40
0.44
1.23
0.03
0.37
0.40
1.11
$
20,360
$
13,044
$
22,241
$
27,848
3,758
(7,632
)
8,063
12,582
2,582
(5,271
)
5,580
8,560
0.39
(0.79
)
0.86
1.32
0.37
(0.79
)
0.79
1.22
17.
Subsequent
events
F-29
Item 13.
Other
Expenses of Issuance and Distribution
Amount
$
9,229
9,125
*
*
*
*
*
*
*
$
*
*
To be filed by amendment.
Item 14.
Indemnification
of Directors and Officers
Item 15.
Recent
Sales of Unregistered Securities
(1)
On
June 30, 2004, the Registrant issued an aggregate of
6,487,950 shares of class A common stock to
stockholders of BioPort Corporation in exchange for an equal
number of outstanding shares of common stock of BioPort. All
other issued and outstanding shares of common stock of BioPort
were repurchased and retired. As a result of this exchange,
BioPort became a wholly owned subsidiary of the Registrant.
(2)
On
June 23, 2005, the Registrant issued an aggregate of
1,264,051 shares of class A common stock to
Microscience Investments Limited, formerly Microscience Holdings
plc, in connection with the acquisition of all the outstanding
shares of capital stock of Microscience Limited.
Item 16.
Exhibits
Item 17.
Undertakings
(a)
The
undersigned registrant hereby undertakes to provide to the
underwriters at the closing specified in the underwriting
agreement, certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser.
(b)
Insofar as
indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that, in the
opinion of the Securities and Exchange Commission, such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid
by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in
connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been
settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in
the Securities Act and will be governed by the final
adjudication of such issue.
(c)
The
undersigned registrant hereby undertakes that:
(i)
For purposes
of determining any liability under the Securities Act of 1933,
the information omitted from the form of prospectus filed as
part of this registration statement in reliance upon
Rule 430A and contained in the form of prospectus filed by
the registrant pursuant to Rule 424(b)(1) or (4) or
497(h) under the Securities Act shall be deemed to be part of
the registration statement as of the time it was declared
effective.
(ii)
For purposes
of determining any liability under the Securities Act, each
post-effective amendment that contains a form of prospectus
shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide offering thereof.
By: |
/s/ Fuad El-Hibri
|
Signature
|
Title
|
Date
|
||||
/s/
Fuad
El-Hibri
|
President, Chief Executive Officer
and Chairman of the Board of Directors
(Principal Executive Officer) |
August 14, 2006 | ||||
/s/
R.
Don Elsey
|
Vice President Finance,
Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer) |
August 14, 2006 | ||||
/s/
Joe
M. Allbaugh
|
Director | August 14, 2006 | ||||
/s/
Zsolt
Harsanyi
|
Director | August 14, 2006 | ||||
/s/
Jerome
M. Hauer
|
Director | August 14, 2006 |
Signature
|
Title
|
Date
|
||||
/s/
Shahzad
Malik
|
Director | August 14, 2006 | ||||
/s/
Ronald
B. Richard
|
Director | August 14, 2006 | ||||
/s/
Louis
Sullivan
|
Director | August 14, 2006 |
Exhibit
1
.1*
Form of Underwriting Agreement
3
.1
Amended and Restated Certificate
of Incorporation of the Registrant
3
.2*
Form of Restated Certificate of
Incorporation of the Registrant to be effective upon completion
of the offering
3
.3
Bylaws of the Registrant
3
.4*
Form of Amended and Restated
By-laws of the Registrant to be effective upon the completion of
the offering
4
.1*
Specimen certificate evidencing
shares of common stock
4
.2
Registration Rights Agreement,
dated June 23, 2005, between the Registrant and
Microscience Investments Limited, formerly Microscience Holdings
plc
4
.3*
Registration Rights Agreement,
dated ,
2006, among the Registrant and the entities listed on
Schedule 1 thereto
4
.4*
Rights Agreement,
dated ,
2006, between the Registrant and the Rights Agent
5
.1*
Opinion of Wilmer Cutler Pickering
Hale and Dorr LLP
9
.1
Voting and Right of First Refusal
Agreement, dated October 21, 2005 between the William J.
Crowe, Jr. Revocable Living Trust and Fuad El-Hibri
9
.2
Voting Agreement, dated
June 30, 2004, between BioPharm, L.L.C. and Michigan
Biologics Products, Inc.
9
.3
Voting Agreement, dated
June 30, 2004, between BioPharm, L.L.C. and Biologika,
L.L.C.
9
.4
Voting Agreement, dated
June 30, 2004, by and among the stockholders named therein
9
.5*
Voting Agreement,
dated ,
2006, between BioPharm, L.L.C. and Microscience Investments
Limited, formerly Microscience Holdings plc
10
.1
Employee Stock Option Plan, as
amended and restated
10
.2
Form of Director Stock Option
Agreement
10
.3*
2006 Stock Incentive Plan
10
.4*
Form of Incentive Stock Option
Agreement under 2006 Stock Incentive Plan
10
.5*
Form of Nonstatutory Stock Option
Agreement under 2006 Stock Incentive Plan
10
.6*
Severance Plan and Termination
Protection Program
10
.7
Form of Indemnity Agreement
10
.8
Contract
No. W9113M-04-D-0002,
dated January 3, 2004, between BioPort Corporation and
U.S. Army Space and Missile Defense Command, as amended
10
.9
Contract
No. 200-2005-11811,
dated May 5, 2005, between BioPort Corporation and
Department of Health and Human Services, Office of Public Health
Emergency Preparedness and Office of Research and Development
Coordination, as amended
10
.10
Filling Services Agreement, dated
March 18, 2002, between BioPort Corporation and
Hollister-Stier Laboratories LLC, as amended
10
.11
BT Vaccine License Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.12
BT Vaccine Development Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.13
rBot Vaccine License Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
10
.14
rBot Vaccine Development
Agreement, dated November 23, 2004, between the Registrant
and the Health Protection Agency
10
.15
Exclusive Distribution Agreement,
dated November 23, 2004, between the Registrant and the
Health Protection Agency
Exhibit
10
.16
Investment Agreement relating to
Microscience Holdings plc, dated March 18, 2005, among the
Wellcome Trust, Microscience Investments Limited, formerly
Microscience Holdings plc, and Emergent Product Development
UK Limited, formerly Microscience Limited, as amended
10
.17
Standard Employment Contract,
dated December 22, 2005, between Emergent Product
Development UK Limited, formerly Emergent Europe Limited, and
Steven N. Chatfield
10
.18
Letter Agreement, dated
July 11, 2006, between the Registrant and Steven N.
Chatfield
10
.19
Consulting Services Agreement,
dated March 1, 2006, between the Registrant and The Hauer
Group
10
.20
Amended and Restated Marketing
Agreement, dated January 1, 2000, between BioPort
Corporation and Intergen N.V.
10
.21
Lease, dated December 1,
1998, between ARE-QRS, Corp. and Antex Biologics Inc., as amended
10
.22
Lease (540 Eskdale Road, Winnersh
Triangle, Wokingham, Berkshire), dated December 13, 1996,
between Slough Properties Limited and Azur Environmental
Limited, as assigned to Emergent Product Development UK Limited,
formerly Microscience Limited
10
.23
Lease (545 Eskdale Road, Winnersh
Triangle, Wokingham, Berkshire), dated December 13, 1996,
between Slough Properties Limited and Azur Environmental
Limited, as assigned to Emergent Product Development UK Limited,
formerly Microscience Limited
10
.24*
Lease Agreement, dated
June 27, 2006, between Brandywine Research LLC and the
Registrant
10
.25
Amended and Restated Loan
Agreement, dated July 29, 2005, between BioPort Corporation
and Fifth Third Bank, as amended
10
.26
Loan and Security Agreement, dated
October 14, 2004, among the Registrant, Emergent Commercial
Operations Frederick Inc., formerly Advanced BioSolutions, Inc.,
Antex Biologics Inc., BioPort Corporation and Mercantile Potomac
Bank
10
.27
Promissory Note, dated
October 14, 2004, from Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., to
Mercantile Potomac Bank
10
.28
Loan Agreement, dated
October 15, 2004, between Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., and the
Department of Business and Economic Development
10
.29
Deed of Trust Note, dated
October 14, 2004, between Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., and the
Department of Business and Economic Development
10
.30
Term Note, dated August 10,
2004, from BioPort Corporation to Fifth Third Bank
10
.31
Loan Agreement, dated
April 25, 2006, among the Registrant, Emergent Frederick
LLC and HSBC Realty Credit Corporation (USA)
10
.32
Bond Purchase Agreement, dated
March 31, 2005, between the County Commissioners of
Frederick County, Emergent Commercial Operations Frederick Inc.,
formerly Emergent Biologics Inc., and Mercantile Potomac Bank
10
.33
License and Co-development
Agreement, dated May 6, 2006, between Emergent Product
Development UK Limited, formerly Emergent Europe Limited, and
Sanofi Pasteur, S.A.
10
.34*
Product Supply Agreement, dated
June 12, 2006, between Emergent Product Development
Gaithersburg Inc. and Talecris Biotherapeutics, Inc.
10
.35*
Election of Fuad El-Hibri to
Participate in the Severance Plan and Termination Protection
Program
10
.36*
Services Agreement, dated August
1, 2006, between East West Resources Corporation and the
Registrant
10
.37*
Director Compensation Program
21
.1*
Subsidiaries of the Registrant
23
.1
Consent of Independent Registered
Public Accounting Firm
23
.2*
Consent of Wilmer Cutler Pickering
Hale and Dorr LLP (included in Exhibit 5.1)
24
.1
Powers of Attorney (included on
signature page)
*
To be filed by amendment.
Confidential treatment requested. Confidential materials omitted
and filed separately with the Securities and Exchange Commission.
(i) | The number of shares constituting that series and the distinctive designation of that series; | ||
(ii) | The dividend rate on the shares of that series, whether dividends shall be cumulative, and, if so, from which date or dates, and the relative rights of priority, if any, of payment of dividends on shares of that series; | ||
(iii) | Whether that series shall have voting rights, in addition to the voting rights provided by law, and, if so, the terms of such voting rights; | ||
(iv) | Whether that series shall have conversion privileges, and, if so, the terms and conditions of such conversion, including provision for adjustment of the conversion rate in such events as the board of directors shall determine; | ||
(v) | Whether or not the shares of that series shall be redeemable, and, if so, the terms and conditions of such redemption, including the date or dates upon or after which they shall be redeemable, and the amount per share |
2
payable in case of redemption, which amount may vary under different conditions and at different redemption dates; |
(vi) | Whether that series shall have a sinking fund for the redemption or purchase of shares of that series, and, if so, the terms and amount of such sinking fund; | ||
(vii) | The rights of the shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the corporation, and the relative rights of priority, if any, of payment of shares of that series; and | ||
(viii) | Any other relative rights, preferences and limitations of that series. |
(i) | Class A Common Stock is not convertible. Each share of Class B Common Stock shall automatically convert into one (1) share of Class A Common Stock, without any action by the Corporation or further action by the holder thereof, immediately prior to the closing of the first underwritten sale of the Corporations securities pursuant to an effective registration statement under the Securities Act of 1933, as amended. | ||
(ii) | In the case of a conversion as a result of the occurrence of the event described in Section 4(e)(i) above, such conversion shall be deemed effective at the time immediately prior to the closing of the underwritten sale of securities pursuant to such registration statement. | ||
(iii) | Following a conversion pursuant to this Section 4(e), the Class B Common Stock shall be eliminated, and the Corporation shall from time to time take such appropriate action as may be necessary to prohibit the reissuance thereof in accordance with the General Corporation Law of the State of Delaware. |
3
(iv) | The Corporation shall reserve and at all times keep available out of its authorized but unissued shares of Class A Common Stock a sufficient number of shares of Class A Common Stock to satisfy the conversion requirements contemplated by this Section 4(e). |
4
5
6
7
8
9
Emergent BioSolutions Inc.
|
||||
By: | /s/ Louis A. Bevilacqua | |||
Louis A. Bevilacqua | ||||
Incorporator | ||||
10
2
3
4
5
6
7
8
9
10
11
12
13
14
15
- 2 -
- 3 -
- 4 -
- 5 -
4. | Payment of Expenses by; Cooperation by, and Obligations of, Prospective Sellers . |
- 6 -
- 7 -
- 8 -
- 9 -
- 10 -
|
If to the Company: | 300 Professional Drive | ||
|
||||
|
Suite 250 | |||
|
Gaithersburg, MD 20879 | |||
|
Fax: (301) 944-0173 | |||
|
Attn: Mr. Daniel J. Abdun-Nabi | |||
|
||||
|
If to PLC or any Holder: | |||
|
||||
|
To the address of PLC as set forth on the signature page hereto. |
- 11 -
- 12 -
- 13 -
COMPANY:
|
EMERGENT BIOSOLUTIONS INC. | |||||
|
||||||
|
By: |
/s/ Fuad El-Hibri
|
||||
Name: Fuad El-Hibri | ||||||
Title: Chairman, President and CEO | ||||||
|
||||||
PLC:
|
MICROSCIENCE HOLDINGS PLC | |||||
|
||||||
|
By: |
/s/ [Illegible]
|
||||
Name: [Illegible] | ||||||
Title: Finance Director | ||||||
|
||||||
Address: | ||||||
|
||||||
MICROSCIENCE HOLDINGS PLC | ||||||
c/o Advent Venture Partners | ||||||
25 Buckingham Gate | ||||||
London SW1E 6LD | ||||||
United Kingdom | ||||||
Fax: 44 20 7828 1474 | ||||||
Attention: Shahzad Malik | ||||||
|
||||||
with a copy to: | ||||||
|
||||||
Morrison & Foerster | ||||||
CityPoint | ||||||
One Ropemaker Street | ||||||
London EC2Y 9AW | ||||||
United Kingdom | ||||||
Fax: 44 20 7496 8500 | ||||||
Attention: James Gubbins |
2
3
|
(i) | If to Mr. Fuad El-Hibri, to: | ||
|
||||
|
Mr. Fuad El-Hibri | |||
|
13340 Signal Tree Lane | |||
|
Potomac, MD 20854 | |||
|
||||
|
(ii) | If to the Trust, to: | ||
|
||||
|
William J. Crowe, Jr. Revocable Living Trust | |||
|
c/o William P. Daisley | |||
|
10834 Brewer House Rd. | |||
|
Rockville, MD 20852 |
4
5
6
William
|
J. Crowe, Jr. Revocable Living Trust | |||
|
By:
|
/s/ William J. Crowe, Jr., Trustee
|
|||
|
||||
/s/ Fuad El-Hibri | ||||
Mr. Fuad El-Hibri |
2
(i) | MBPI shall first deliver to BioPharm a written notice (the First Offer Notice ), which First Offer Notice shall be irrevocable for a period of 7 days after receipt thereof, offering to sell to BioPharm at Fair Market Value (as defined below) all of such shares of capital stock of the Company that MBPI desires to sell. | ||
(ii) | BioPharm shall have the right and option to notify MBPI, in a writing delivered within 7 days of receipt of the First Offer Notice, of its election to purchase all or any portion of the shares offered under the First Offer Notice at Fair Market Value and consummate such purchase within 7 days thereafter. Any shares so acquired from MBPI shall no longer be subject to this Agreement. | ||
(iii) | If BioPharm declines to purchase all or any portion of the shares subject to the First Offer Notice, MBPI shall have the right to sell such shares in a Public Sale Transaction free from any restriction hereunder, including but not limited to the legend set forth in Section 5(b) above. Any shares not sold in accordance with the procedure set forth in this Section 5 shall remain subject to this Agreement. | ||
(iv) | Fair Market Value of a share of capital stock of the Company as of a specified date for the purposes of this Section 5 shall mean the closing price of a share of such capital stock on the principal securities exchange on which such shares are traded on the day immediately preceding the date as of which Fair Market Value is being determined, or on the next preceding date on which such shares are traded if no shares were traded on such immediately preceding day, or if the shares are not traded on a securities exchange, Fair Market Value shall be deemed to be the average of the high bid and low asked prices of the shares in the over-the-counter market on the day immediately preceding the date as of which Fair Market Value is being determined or on the next preceding date on which such high bid and low asked prices were recorded. |
3
4
5
6
BIOPHARM, LLC
|
||||
By: | /s/ Robert G. Kramer | |||
Name: | Robert G. Kramer | |||
Title: | General Manager | |||
MICHIGAN BIOLOGICS PRODUCTS, INC.
|
||||
By: | /s/ [Illegible] | |||
Name: | ||||
Title: | ||||
7
(i) | Biologika shall first deliver to BioPharm a written notice (the First Offer Notice ), which First Offer Notice shall be irrevocable for a period of 7 days after receipt thereof, offering to sell to BioPharm at Fair Market Value (as defined below) all of such shares of capital stock of the Company that Biologika desires to sell. |
2
(ii) | BioPharm shall have the right and option to notify Biologika, in a writing delivered within 7 days of receipt of the First Offer Notice, of its election to purchase all or any portion of the shares offered under the First Offer Notice at Fair Market Value and consummate such purchase within 7 days thereafter. Any shares so acquired from Biologika shall no longer be subject to this Agreement. | ||
(iii) | If BioPharm declines to purchase all or any portion of the shares subject to the First Offer Notice, Biologika shall have the right to sell such shares in a Public Sale Transaction free from any restriction hereunder, including but not limited to the legend set forth in Section 5(b) above. Any shares not sold in accordance with the procedure set forth in this Section 5 shall remain subject to this Agreement. | ||
(iv) | Fair Market Value of a share of capital stock of the Company as of a specified date for the purposes of this Section 5 shall mean the closing price of a share of such capital stock on the principal securities exchange on which such shares are traded on the day immediately preceding the date as of which Fair Market Value is being determined, or on the next preceding date on which such shares are traded if no shares were traded on such immediately preceding day, or if the shares are not traded on a securities exchange, Fair Market Value shall be deemed to be the average of the high bid and low asked prices of the shares in the over-the-counter market on the day immediately preceding the date as of which Fair Market Value is being determined or on the next preceding date on which such high bid and low asked prices were recorded. |
3
(i) | If to BioPharm, to: | ||
BioPharm, LLC
3500 N. Martin Luther King, Jr. Blvd. Building One, 3 rd Floor Lansing, MI 48906 Attn: Robert G. Kramer, Sr. |
|||
(ii) | If to Biologika, to: | ||
Mauro I. Gibellini
300 Professional Drive Gaithersburg, Maryland 20879 |
4
5
BIOPHARM, L.L.C.
|
||||
By: | /s/ Robert G. Kramer | |||
Name: | Robert G. Kramer | |||
Title: | ||||
BIOLOGIKA, L.L.C.
|
||||
By: | /s/ Mauro Gibellini | |||
Name: | Mauro Gibellini | |||
Title: | General Manager | |||
6
2
3
4
5
INTERVAC, LLC | ||||||
|
||||||
|
By: | /s/ Fuad El-Hibri | ||||
|
||||||
|
Name: Fuad El-Hibri | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
Intervac, LLC | ||||||
1684 East Gude Drive | ||||||
Suite 301 | ||||||
Rockville, MD 20850 | ||||||
Attn: Fuad El-Hibri |
BIOPHARM, LLC | ||||||
|
||||||
|
By: | /s/ Robert G. Kramer | ||||
|
||||||
|
Name: Robert G. Kramer | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
BioPharm, LLC | ||||||
3500 N. Martin Luther King, Jr. Blvd. | ||||||
Building One, 3rd Floor | ||||||
Lansing, MI 48906 | ||||||
Attn: Robert G. Kramer |
2
MICHIGAN BIOLOGICS PRODUCTS, INC. | ||||||
|
||||||
|
By: | /s/ Robert C. Myers | ||||
|
||||||
|
Name: Robert C. Myers | |||||
|
Title: President | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
Michigan Biologics Products, Inc. | ||||||
3500 N. Martin Luther King, Jr. Blvd. | ||||||
Building One, 3rd Floor | ||||||
Lansing, MI 48906 | ||||||
Attn: Robert C. Myers |
3
BIOVAC, LLC | ||||||
|
||||||
|
By: | /s/ Fuad El-Hibri | ||||
|
||||||
|
Name: Fuad El-Hibri | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
BioVac, LLC | ||||||
1684 East Gude Drive | ||||||
Suite 301 | ||||||
Rockville, MD 20850 | ||||||
Attn: Fuad El-Hibri |
4
BIOLOGIKA, LLC | ||||||
|
||||||
|
By: | /s/ Mauro Gibellini | ||||
|
||||||
|
Name: Mauro Gibellini | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
Biologika, LLC | ||||||
3500 N. Martin Luther King, Jr. Blvd. | ||||||
Building One, 3rd Floor | ||||||
Lansing, MI 48906 | ||||||
Attn: Mauro Gibellini |
5
INTERVAC MANAGEMENT, LLC | ||||||
|
||||||
|
By: | /s/ Fuad El-Hibri | ||||
|
||||||
|
Name: Fuad El-Hibri | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
Intervac Management, LLC | ||||||
1684 East Gude Drive | ||||||
Suite 301 | ||||||
Rockville, MD 20850 | ||||||
Attn: Fuad El-Hibri |
6
ARPI, LLC | ||||||
|
||||||
|
By: | /s/ Janice Mugriditchian | ||||
|
||||||
|
Name: Janice Mugriditchian | |||||
|
Title: General Manager | |||||
|
||||||
Address for Notices: | ||||||
|
||||||
ARPI, LLC | ||||||
12001 Glen Road | ||||||
Potomac, MD 20854 | ||||||
Attn: Janice Mugriditchian |
7
Class A Shares
Number of Shares
Percent of Total Shares
2,890,000
44.54
%
1,412,896
21.78
%
672,500
10.36
%
555,822
8.57
%
477,941
7.37
%
250,000
3.85
%
228,791
3.53
%
6,487,950
100
%
2
3
4
5
6
7
8
9
10
11
Vesting Schedule | Date First Exercisable | Expiration Date | ||
33 1/3%
|
[ ] | [ ] | ||
|
||||
33 1/3%
|
[ ] | [ ] | ||
|
||||
33 1/3%
|
[ ] | [ ] |
2
3
4
5
6
Emergent BioSolutions Inc., a Delaware Corporation | ||||
|
||||
|
By: | |||
|
||||
|
Name: | |||
|
Title: |
|
||||
|
Name: | |||
|
Date: |
7
2
3
4
Emergent BioSolutions Inc. | ||||
|
||||
|
By: | |||
|
||||
|
Name: | |||
|
Title: | |||
|
||||
Indemnitee | ||||
|
||||
[Name] |
5
SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDERUNDER DPAS (15 CFR 700)RATING DO-C9 |
PAGE OF PAGES 1 26 2. CONTRACT NUMBER 3. SOLICITATION NUMBER 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER W9113M-04-D-0002 W9113M-0R-4-0004 4. TYPE OF SOLICITATION 11/18/2003 W90GXK33010005 ¨ SEALED BID (IFB) ¨ NEGOTIATED (RFP) 7. ISSUED BY CODE W9113M 8. ADDRESS OFFER TO ( if other than Item 7 ) Same US Army Space and Missile Defense Command, 64 Thomas Johnson Drive Frederick, MD 21702 NOTE: In sealed bid solicitations offer and offeror mean bid and bidder. SOLICITATION 9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until local time (Hour) (Date) CAUTION LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation. 10. FOR INFORMATION A. NAME C. E-MAIL ADDRESS CALL: Lynn M. Selfridge B. TELEPHONE (NO COLLECT CALLS) Lynne.Selfridge@SMCC.A AREA CODE NUMBER EXT. 301 619-2707 11. TABLE OF CONTENTS (X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S) - - PART I THE SCHEDULE PART II CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 12-26 X B SUPPLIES OR SERVICES AND PRICES/COSTS 2-3 PART III LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. - X C DESCRIPTION/SPECS./WORK STATEMENT 4-6 X J LIST OF ATTACHMENTS 26 - D PACKAGING AND MARKING PART IV REPRESENTATIONS AND INSTRUCTIONS REPRESENTATIONS, CERTIFICATIONS AND OTHER X E INSPECTION AND ACCEPTANCE 7 K STATEMENTS OF OFFERORS X F DELIVERIES OR PERFORMANCE 8 - X G CONTRACT ADMINISTRATION DATA 9 L INSTRS., CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 10-11 M EVALUATION FACTORS FOR AWARD OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period. |
12. In compliance with the above, the undersigned agrees, if this offer is accepted within 60 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule. 13. DISCOUNT FOR PROMPT PAYMENT (See Section I, Clause No. 52.232-8) 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%) |
14. ACKNOWLEDGEMENT OF AMEND- MENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated) : AMENDMENT NO. DATE AMENDMENT NO. DATE |
15A. NAME AND ADDRESS 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER OF OFFER- (Type or print) OR CODE 1H0B6 FACILITY Robert G. Kramer, President BioPort Corporation 3500 N. Martin Luther King JR., Blvd. Lansing, Michigan 48906 15C. CHECK IF REMITTANCE ADDRESS IS DIFFERENT FROM ABOVE ENTER SUCH 17. SIGNATURE 18. OFFER DATE 15B. TELEPHONE NUMBER ¨ ADDRESS IN SCHEDULE. /s/ Robert G. Kramer Jan. 3, 2004 |
AREA CODE NUMBER 517 327 1579 EXT. - |
AWARD (To be completed by Government) |
19. ACCEPTED AS TO ITEMS NUMBERED 21. ACCOUNTING AND APPROPRIATION 0001-0003 20. AMOUNT To be cited on individual delivery orders 22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 23. SUBMIT INVOICES TO ADDRESS ITEM SHOWN IN (4 copies unless otherwise specified) ý 10 U.S.C. 2304(c) (1) ¨ 41 U.S.C. 253(c) ( ) |
24. ADMINISTERED BY (If other than Item 7) CODE S2303A 25. PAYMENT WILL BE MADE BY CODE DCMA Detroit-Grand Rapids DFAS-Columbus 678 Front Avenue, NW ATTN: DFAS-CO/Chesapeake, PO Box 182264 Grand Rapids, MI 49504-5352 Columbus, Ohio 43218-2264 |
26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE Lynn M. Selfridge (Signature of Contracting Officer) 01/02/2004 |
IMPORTANT Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice. AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97) Previous edition is unusable Prohibited by GSA FAR (48 CFR) 53.214(c) |
MAX | ||||||||||||||||||
ITEM NO | SUPPLIES/SERVICES | QUANTITY | UNIT | UNIT PRICE | MAX AMOUNT | |||||||||||||
0002 |
|
[**] | $ | [**] | $ | 95,950,567.80 | ||||||||||||
OPTION |
|
|||||||||||||||||
|
||||||||||||||||||
Doses of Vaccine
FFP as identified in Section C, during the period of January 1, 2005 through December 31, 2005. PURCHASE REQUEST NUMBER: W90GXK33010005 |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
MAX NET AMT | $ | 95,950,567.80 | |||||||||||||||
|
||||||||||||||||||
Funded Amount | $ | 0.00 |
MINIMUM
MINIMUM
MAXIMUM
MAXIMUM
CLIN
QUANTITY
AMOUNT
QUANTITY
AMOUNT
1,297,380
[**]
[**]
71,248,954
1,533,090
[**]
[**]
$
95,950,568
1,034,930
[**]
[**]
$
78,340,434
1. | Manufacture | ||
2. | Formulation | ||
3. | Filling | ||
4. | FDA Release |
CLIN
INSPECT AT
INSPECT BY
ACCEPT AT
ACCEPT BY
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
Origin (Contractors Facility)
Government
CLIN | DELIVERY DATE | QUANTITY | SHIP TO ADDRESS | UIC | ||||
0001
|
IAW Attachment No. 1 in Section J of the Contract | 1,297,380 | To be determined | TBD | ||||
0002
|
Will be provided at time of exercising option. | 1,533,090 | To be determined | TBD | ||||
0003
|
Will be provided at time of exercising option. | 1,034,930 | To be determined | TBD |
52.232-25
|
Prompt Payment | OCT 2003 | ||
52.242-13
|
Bankruptcy | JUL 1995 | ||
52.245-4
|
Government-Furnished Property (Short Form) | JUN 2003 | ||
252.204-7004
|
Required Central Contractor Registration | NOV 2001 | ||
252.245-7001
|
Reports Of Government Property | MAY 1994 |
Attachment Number
Description
No. of Pages
1
1
2
22
3
1
Attachment 1
Page 1 of 1
50
%
30
%
10
%
10
%
Attachment 2
ent Owned Equipment
Page 1
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
R
Bu
9/1/93
Warehouse modular facility
264,674.00
DAMD17-91-C-1139
R
Bu
9/1/93
BL-3 Modular Facility
1,484,553.00
Bu
Sub Total:
1,749,227.00
DAMD17-91-C-1139
P
Co
9/1/93
Thermal Transfer Printer
7,128.00
DAMD17-91-C-1139
P
Co
9/1/93
Security room console, power panel, conduit and wi
20,000.00
DAMD17-91-C-1139
P
Co
9/1/93
door alarms, motion detectors, card readers, card ac
50,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Intercom system to gates central control, remote an
60,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Host computer, remote processors, conduit and wiri
80,000.00
DAMD17-91-C-1139
P
Co
9/1/93
Cameras, Video control, re corders, multiplexers, n
120,000.00
DAMD17-91-C-1139
P
Co
9/1/98
Printer Hewlitt Packard
300.00
DAMD17-91-C-1139
P
Co
9/1/98
Printer Epson
387.00
DAMD17-91-C-1139
P
Co
2/1/00
Compaq Proliant ML570 Server and Rack Mounts I
15,497.00
DAMD17-91-C-1139
P
Co
3/1/00
HP Laserjet Printer 4050N
1,360.00
DAMD17-91-C-1139
P
Co
3/1/00
Computer
1,499.97
DAMD17-91-C-1139
P
Co
3/1/00
Computer
1,699.97
DAMD17-91-C-1139
P
Co
3/1/00
Computer System
2,128.98
DAMD17-91-C-1139
P
Co
3/1/00
Z505R Laptop Computers
2,538.24
DAMD17-91-C-1139
P
Co
3/1/00
Mail server
3,624.61
DAMD17-91-C-1139
P
Co
3/1/00
Laptop Computers
3,711.24
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Computer System
633.32
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
4/1/00
Bar Code Scanners
2,605.50
DAMD17-91-C-1139
P
Co
4/1/00
Bar Code Scanners
2,605.50
DAMD17-91-C-1139
P
Co
4/1/00
Compaq Proliant ML370
3,400.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Viewsonic E771 .27MM
232.50
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Proliant 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.13
DAMD17-91-C-1139
P
Co
7/1/00
17 P793 Monitor
606.13
DAMD17-91-C-1139
P
Co
7/1/00
Compaq Pesario 7360 K6 500
606.14
DAMD17-91-C-1139
P
Co
8/1/00
Monitors
221.43
DAMD17-91-C-1139
P
Co
8/1/00
Computers
651.43
DAMD17-91-C-1139
P
Co
8/1/00
Laptop Computers F420
1,660.00
DAMD17-91-C-1139
P
Co
8/1/00
Epson Projector
5,322.00
DAMD17-91-C-1139
P
Co
8/1/00
Compaq Proliant Server and Rack
5,908.74
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.25
DAMD17-91-C-1139
P
Co
9/1/00
Viewsonic 17 Color Monitor
227.26
DAMD17-91-C-1139
P
Co
9/1/00
Monitor
296.78
DAMD17-91-C-1139
P
Co
9/1/00
Printer
690.00
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.06
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
HP E-PC E-Vectra
787.08
DAMD17-91-C-1139
P
Co
9/1/00
CPU
1,383.52
DAMD17-91-C-1139
P
Co
9/1/00
Compaq Deskpro En NT Workstation
1,878.91
DAMD17-91-C-1139
P
Co
9/1/00
Compaq Proliant ML530 Server and Parts
10,842.00
DAMD17-91-C-1139
P
Co
10/1/00
HP Brio BA410 Computer
1,019.35
DAMD17-91-C-1139
P
Co
10/1/00
Compaq Deskpro En Workstation
1,440.00
DAMD17-91-C-1139
P
Co
11/1/00
Viewsonic 17 Color Monitor
228.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz and Viewsoni
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Compaq Deskpro EN Pen III 733 mhz and Viewsonic
1,318.87
DAMD17-91-C-1139
P
Co
11/1/00
Datafile Diskette for VAERS
1,344.00
DAMD17-91-C-1139
P
Co
12/1/00
Elron Software Server
3,669.46
DAMD17-91-C-1139
P
Co
12/1/00
Security System Upgrade, Camera and wiring neces
128,502.20
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/1/01
Viewsonic 17 Color Monitor
189.99
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro EN
1,337.74
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
1/1/01
Compaq Deskpro Workstation Ap250
1,887.00
DAMD17-91-C-1139
P
Co
2/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
2/1/01
Computer System Okidata 14E printer
371.04
DAMD17-91-C-1139
P
Co
2/1/01
Computer System
1,853.40
DAMD17-91-C-1139
P
Co
2/1/01
Compaq Proliant ML570 Server and Rack Mounts
20,376.50
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Viewsonic E70
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitors for PAI Workroom
270.89
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Monitor
290.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer System
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer System
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computer Deskpro
1,220.00
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Compaq PC
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Compaq Deskpro EN
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computer
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computers for PAI Workroom
1,263.89
DAMD17-91-C-1139
P
Co
3/1/01
Computer
1,263.91
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Monitor
186.00
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
DAMD17-91-C-1139
P
Co
4/1/01
Computer Systems
1,017.50
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
4/1/01
Server-Snap for PAI Workroom
2,405.00
DAMD17-91-C-1139
P
Co
4/1/01
Server-Snap for PAI Workroom
2,405.00
DAMD17-91-C-1139
P
Co
5/1/01
All in one Printer Fax Copier
784.00
DAMD17-91-C-1139
P
Co
6/1/01
UPS for Domain Controller
16,075.32
DAMD17-91-C-1139
P
Co
6/1/01
UPS for Domain Controller
16,075.32
DAMD17-91-C-1139
P
Co
7/1/01
IS Monitor
897.23
DAMD17-91-C-1139
P
Co
8/24/01
Developer Server
4,024.41
DAMD17-91-C-1139
P
Co
8/29/01
PowerEdge 700MHZ
10,310.28
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/1/01
Dell Optiplex GX 240 Small Mini Tower
1,430.83
DAMD17-91-C-1139
P
Co
11/2/01
Security System Multiplexer
2,313.18
DAMD17-91-C-1139
P
Co
11/26/01
Dell Optiplex GX 240 Small Mini Tower
1,213.91
DAMD17-91-C-1139
P
Co
11/28/01
Closed Circuit TV System
157,025.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 1700 Router
1,066.36
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3512 Network Switch
2,065.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3524 Network Switch
2,507.57
DAMD17-91-C-1139
P
Co
1/11/02
Pix Firewall 515 FO-Bun
2,552.97
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 3548 Network Switch
4,216.48
DAMD17-91-C-1139
P
Co
1/11/02
Cisco 6509 Switch
10,005.27
DAMD17-91-C-1139
P
Co
1/11/02
Pix Firewall 515UR
10,212.90
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/11/02
URT Policy Server 100Series
10,636.37
DAMD17-91-C-1139
P
Co
1/11/02
URT Policy Server 1100Series
10,636.37
DAMD17-91-C-1139
P
Co
1/11/02
Cisco Intrusion Detection System 4210
12,416.38
DAMD17-91-C-1139
P
Co
1/24/02
Flat Panel 340 Minitower Monitor 1702FD
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
Dell P793 Monitor
274.54
DAMD17-91-C-1139
P
Co
1/24/02
17 P793 Monitor
296.64
DAMD17-91-C-1139
P
Co
1/24/02
17 P793 Monitor
296.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
19 P992 Monitor
451.64
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Dell Optiplex GX 240 Small Mini Tower
974.14
DAMD17-91-C-1139
P
Co
1/24/02
Precision 340 Minitower Workstation-Labwatch Sy
1,629.21
DAMD17-91-C-1139
P
Co
1/31/02
Exchange Bundle Media Kin
20.00
DAMD17-91-C-1139
P
Co
1/31/02
Server
4,837.49
DAMD17-91-C-1139
P
Co
2/28/02
Security System Workstation (CPU)
4,274.89
DAMD17-91-C-1139
P
Co
2/28/02
Security System Workstation (Monitor)
4,274.90
DAMD17-91-C-1139
P
Co
3/29/02
Plain-paper Impact printer
448.88
DAMD17-91-C-1139
P
Co
3/29/02
Maintenance Agreement
25,725.70
DAMD17-91-C-1139
P
Co
3/29/02
Computer Services
31,225.24
DAMD17-91-C-1139
P
Co
3/29/02
Computer Supplies
134,486.81
DAMD17-91-C-1139
P
Co
4/12/02
Dell Optiplex GX 240 Small Mini Tower
1,786.09
DAMD17-91-C-1139
P
Co
4/12/02
Profile 3 SE
1,934.00
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.29
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.30
DAMD17-91-C-1139
P
Co
7/1/02
17 P793 Monitor
482.30
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
7/1/02
Dell Optiplex GX 240 Small Mini Tower
1,181.91
DAMD17-91-C-1139
P
Co
9/1/02
Staging Server-Sandbox
4,091.61
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
9/1/02
Network Back Up
4,516.82
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
10/1/02
Dell P793 Monitor
350.26
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.94
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
DAMD17-91-C-1139
P
Co
10/1/02
Dell Optiplex GX 240 Small Mini Tower
1,250.95
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell M782 Monitor
350.00
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.08
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
DAMD17-91-C-1139
P
Co
5/1/03
Dell Optiplex GX 240 Small Mini Tower
1,230.09
Co
127,357.24
(40,000.00
)
(6,528.00
)
1,225.98
1,408,629.95
DAMD17-91-C-1139
P
Eq
9/1/93
Refrigerator
530.00
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Chart recorder
1,071.43
DAMD17-91-C-1139
P
Eq
9/1/93
Incubator
2,600.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
9/1/93
Radios
3,375.00
DAMD17-91-C-1139
P
Eq
9/1/93
6 Biological Safety Cabinet
9,800.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cages and racks
12,750.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cages and racks
12,750.00
DAMD17-91-C-1139
P
Eq
9/1/93
Biocontainment Hood - 8 Biological Safety Cabine
18,500.00
DAMD17-91-C-1139
P
Eq
9/1/93
Wire security carts
19,681.00
DAMD17-91-C-1139
P
Eq
9/1/93
Labeler
27,415.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cagewasher
41,600.00
DAMD17-91-C-1139
P
Eq
9/1/93
Small Autoclave
61,300.00
DAMD17-91-C-1139
P
Eq
9/1/93
Large Autoclave
124,400.00
DAMD17-91-C-1139
P
Eq
9/1/93
5 Animal Cubicles
130,000.00
DAMD17-91-C-1139
P
Eq
9/1/93
Vial Capper
132,977.00
DAMD17-91-C-1139
P
Eq
9/1/93
Tray Loader
132,977.00
DAMD17-91-C-1139
P
Eq
9/1/93
Diesel generator, fuel tank, conduit and wiring
175,000.00
DAMD17-91-C-1139
P
Eq
9/1/93
Cartoner
242,260.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Heat Exchanger
3,715.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Pump
4,405.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Pump
4,405.00
DAMD17-91-C-1139
P
Eq
9/1/97
Air Handling Unit
7,012.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Heat Exchanger
10,890.00
DAMD17-91-C-1139
P
Eq
9/1/97
Vertical Conveyor
14,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Storage Tanks
17,933.00
DAMD17-91-C-1139
P
Eq
9/1/97
Air Handling (Condensing) Unit
17,950.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean in place piping
18,750.00
DAMD17-91-C-1139
P
Eq
9/1/97
SIP Station and Piping
20,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Distribution Piping
25,000.00
DAMD17-91-C-1139
P
Eq
9/1/97
WFI Cooling System
26,122.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Generator
78,628.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean Steam Generator
125,875.00
DAMD17-91-C-1139
P
Eq
9/1/97
Clean in Place Skid (Pump, Heat Exchanger, Electri
174,066.00
DAMD17-91-C-1139
P
Eq
9/1/97
eGMP Autoclave
186,900.00
DAMD17-91-C-1139
P
Eq
9/1/98
Water closet
150.00
DAMD17-91-C-1139
P
Eq
9/1/98
Lavatory (2)
300.00
DAMD17-91-C-1139
P
Eq
9/1/98
sinks (2)
300.00
DAMD17-91-C-1139
P
Eq
9/1/98
Hot water heater
450.00
DAMD17-91-C-1139
P
Eq
9/1/98
Mop Receptor
500.00
DAMD17-91-C-1139
P
Eq
9/1/98
heat water pump
700.00
DAMD17-91-C-1139
P
Eq
9/1/98
air separator
800.00
DAMD17-91-C-1139
P
Eq
9/1/98
Emergency Shower/Eyebath
900.00
DAMD17-91-C-1139
P
Eq
9/1/98
hot water reticulator
1,300.00
DAMD17-91-C-1139
P
Eq
9/1/98
Expansion tank
1,500.00
DAMD17-91-C-1139
P
Eq
9/1/98
by-pass chemical feeder
1,800.00
DAMD17-91-C-1139
P
Eq
9/1/98
Glove extenders for rigid and flex wall systems
1,800.00
DAMD17-91-C-1139
P
Eq
9/1/98
steam condensate pump
2,200.00
DAMD17-91-C-1139
P
Eq
9/1/98
2 Undercounter Refrigerators
2,848.00
DAMD17-91-C-1139
P
Eq
9/1/98
Heat Exchangers (3)
3,000.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
9/1/98
Nitrogen regulator
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
CO2 regulator
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Double Sink (Stainless)
3,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Folding Lockable Carts
3,580.00
DAMD17-91-C-1139
P
Eq
9/1/98
Horizontal Laminat Flow Hood
4,870.00
DAMD17-91-C-1139
P
Eq
9/1/98
Sterility Isolator Air Handling System
5,573.00
DAMD17-91-C-1139
P
Eq
9/1/98
Biosafety Cabinet
6,709.00
DAMD17-91-C-1139
P
Eq
9/1/98
Jacket Water reservoir
8,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Reach-in refrigerators (2)
9,784.00
DAMD17-91-C-1139
P
Eq
9/1/98
New panel for EMS, Honeywell
10,133.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 4
11,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Stainless steel benchwork, racks and tables
17,670.00
DAMD17-91-C-1139
P
Eq
9/1/98
Bag-in/Bag-out filters
18,395.00
DAMD17-91-C-1139
P
Eq
9/1/98
Laboratory Casework (Stainless Steel)
18,950.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 5 Air Handling Unit
19,787.50
DAMD17-91-C-1139
P
Eq
9/1/98
AHU 7 Air Handling Unit
19,787.50
DAMD17-91-C-1139
P
Eq
9/1/98
Standard Guinea Pig Unit
20,100.00
DAMD17-91-C-1139
P
Eq
9/1/98
Standard Guinea Pig Unit
20,100.00
DAMD17-91-C-1139
P
Eq
9/1/98
Process Chiller
23,000.00
DAMD17-91-C-1139
P
Eq
9/1/98
Holding tank
26,468.00
DAMD17-91-C-1139
P
Eq
9/1/98
Carbon Filter, Building 16, Penthouse
26,700.00
DAMD17-91-C-1139
P
Eq
9/1/98
AHU-3
28,875.00
DAMD17-91-C-1139
P
Eq
9/1/98
SE Recruiting Water System
34,825.43
DAMD17-91-C-1139
P
Eq
9/1/98
5 tanks retrofit old tanks
72,677.54
DAMD17-91-C-1139
P
Eq
9/1/98
Glassware washer/dryer
76,656.00
DAMD17-91-C-1139
P
Eq
9/1/98
GMP autoclave
136,225.00
DAMD17-91-C-1139
P
Eq
9/1/98
Barrior Isolation Units and VHP Generator
189,000.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Lockable Cages
530.00
DAMD17-91-C-1139
P
Eq
9/1/99
Sterility Isolator Parts
6,702.55
DAMD17-91-C-1139
P
Eq
9/1/99
6 SS difuseable pans
8,820.00
DAMD17-91-C-1139
P
Eq
9/1/99
hood and bench laminar flow
9,224,35
DAMD17-91-C-1139
P
Eq
9/1/99
Redundant HVAC BL-3
31,919.00
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf CH-500 Column Heater
2,225.36
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf Centrifuge 5417R w/rotor
5,357.00
DAMD17-91-C-1139
P
Eq
3/1/00
Eppendorf Centrifuge 5417R w/rotor
5,357.00
DAMD17-91-C-1139
P
Eq
3/1/00
96 Well Plate Washer
7,229.16
DAMD17-91-C-1139
P
Eq
3/1/00
Imaging Densiometer
11,500.09
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
4/1/00
BioChemistry Analyzer
11,865.00
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.93
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.94
DAMD17-91-C-1139
P
Eq
6/1/00
Control Box & Digital Display for Steinmixer
1,504.94
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
SL Stainless Pressure Vessel
1,226.65
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
7/1/00
Standard Guinea Pig Unit & Watering Unit
3,789.90
DAMD17-91-C-1139
P
Eq
8/1/00
Pen & Multichannel Recorder & Enclosure
1,940.00
DAMD17-91-C-1139
P
Eq
8/1/00
Pen & Multichannel Recorder & Enclosure
2,950.00
DAMD17-91-C-1139
P
Eq
8/1/00
150L Holding Tank
26,434.44
DAMD17-91-C-1139
P
Eq
8/1/00
150L Holding Tank
26,434.44
DAMD17-91-C-1139
P
Eq
8/1/00
SIP Lead Equipment
45,257.61
DAMD17-91-C-1139
P
Eq
8/1/00
Vial Washer GW24
64,434.00
DAMD17-91-C-1139
P
Eq
9/1/00
SAIP Filling & Packaging Project
59,759.13
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
Temperature Carts for Redundancy Filling and Packs
7,738.84
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
10/1/00
5 Cages for transportation to Contract Filler
15,084.06
DAMD17-91-C-1139
P
Eq
11/1/00
Heat Exchange Redesign
28,533.31
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.26
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
12/1/00
Standard Guinea Pig Unit & Watering Unit
4,402.27
DAMD17-91-C-1139
P
Eq
1/1/01
Kjeldahl digestion apparatus, rotary base
1,810.00
DAMD17-91-C-1139
P
Eq
3/1/01
Rapid Still 1, Labonco
2,850.00
DAMD17-91-C-1139
P
Eq
4/1/01
Trash Pump
1,088.57
DAMD17-91-C-1139
P
Eq
4/1/01
Mini Neph Unit and Printer
3,357.50
DAMD17-91-C-1139
P
Eq
4/1/01
Fermentor Datalogger
5,870.85
DAMD17-91-C-1139
P
Eq
4/1/01
ExMark Mower
8,914.54
DAMD17-91-C-1139
P
Eq
5/1/01
Honeywell Chart Recorder
2,114.89
DAMD17-91-C-1139
P
Eq
5/1/01
Honeywell Chart Recorder
2,114.90
DAMD17-91-C-1139
P
Eq
5/1/01
Flange Fitness Gauge
4,129.00
DAMD17-91-C-1139
P
Eq
5/1/01
Centrifuge with Rotor and Microplus Carriers
7,908.25
DAMD17-91-C-1139
P
Eq
5/1/01
Machining of Formulation Tanks Project 211
32,138.82
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
5/1/01
TOC Analyzer
33,621.26
DAMD17-91-C-1139
P
Eq
5/1/01
Building 1 Air Conditioning Unit
92,633.24
DAMD17-91-C-1139
P
Eq
6/1/01
Chryo Freezer
13,962.33
DAMD17-91-C-1139
P
Eq
6/1/01
Stability Chamber
17,906.00
DAMD17-91-C-1139
P
Eq
6/1/01
Stability Chamber
17,906.00
DAMD17-91-C-1139
P
Eq
7/1/01
Fuel Tank
2,236.81
DAMD17-91-C-1139
P
Eq
7/1/01
Stainless Steel Carts
7,248.00
DAMD17-91-C-1139
P
Eq
7/1/01
RO System Move to Bld 30
199,603.53
DAMD17-91-C-1139
P
Eq
8/15/01
Undercounter Refrigerator
747.00
DAMD17-91-C-1139
P
Eq
8/21/01
Automatic Polarimeter
19,465.00
DAMD17-91-C-1139
P
Eq
8/30/01
Sanitary Conical Tank
2,838.68
DAMD17-91-C-1139
P
Eq
9/1/01
Clean Steam Generators Outlet Piping Modification
12,260.00
DAMD17-91-C-1139
P
Eq
9/10/01
Compressor for Building 45
4,067.00
DAMD17-91-C-1139
P
Eq
9/25/01
Ice Flaker
2,180.00
DAMD17-91-C-1139
P
Eq
10/1/01
Repair to Forklift Mast System
1,245.49
DAMD17-91-C-1139
P
Eq
10/1/01
GPS System for contract filler truck
2,212.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Vial Rinser
5,300.00
DAMD17-91-C-1139
P
Eq
10/1/01
Security Related Equipment
22,809.97
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Filling Pumps
35,000.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Ultrasonic Bath
44,343.00
DAMD17-91-C-1139
P
Eq
10/1/01
Hollister Stier-Cold Room
136,740.00
DAMD17-91-C-1139
P
Eq
10/25/01
Refrigerator
2,986.90
DAMD17-91-C-1139
P
Eq
10/25/01
Haske Bath
3,017.71
DAMD17-91-C-1139
P
Eq
10/25/01
Incubator
3,987.00
DAMD17-91-C-1139
P
Eq
11/7/01
Condensate Tanks
11,780.00
DAMD17-91-C-1139
P
Eq
11/8/01
Tube Bender
5,275.08
DAMD17-91-C-1139
P
Eq
11/20/01
AVA Kill Tank System
5,763.03
DAMD17-91-C-1139
P
Eq
12/1/01
Pipe Rack Modifications
29,728.12
DAMD17-91-C-1139
P
Eq
12/1/01
Modifications to Trains 2, 3, 4
77,813.20
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kheldahl
1,349.92
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kjeldahl
1,349.92
DAMD17-91-C-1139
P
Eq
12/3/01
Micro Kjeldahl
2,091.18
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/18/01
Micro Kjeldahl Distillation
2,035.97
DAMD17-91-C-1139
P
Eq
12/31/01
Nikon Eclipse E400
7,245.26
DAMD17-91-C-1139
P
Eq
1/1/02
Building #12 Fermentation Room Camera
8,642.00
DAMD17-91-C-1139
P
Eq
1/8/02
Undercounter Continental Refrigerator 7.4cft
1,727.26
DAMD17-91-C-1139
P
Eq
1/8/02
Bench Top Incubator Shaker
5,160.00
DAMD17-91-C-1139
P
Eq
1/8/02
Artel Pipette Calibration System
8,105.62
DAMD17-91-C-1139
P
Eq
1/8/02
Incubator Shaker
8,930.00
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 SCP Printer Kit
1,189.06
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 SCP Printer Kit
1,189.06
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 Spectrophotometer
5,371.56
DAMD17-91-C-1139
P
Eq
1/21/02
UV1201 Spectrophotometer
5,371.56
DAMD17-91-C-1139
P
Eq
1/31/02
Tunnel Camera and Motion Units
66,109.02
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
1/31/02
Trailer for Contract Filler
85,145.82
DAMD17-91-C-1139
P
Eq
1/31/02
Fire Alarm System Upgrade
273,375.00
DAMD17-91-C-1139
P
Eq
2/28/02
Locknetics Prox Cipher Locks
8,000.00
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (1of3 Stations)
9,623.32
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (2of3 Stations)
9,623.34
DAMD17-91-C-1139
P
Eq
2/28/02
EMS System Upgrade (3of3 Stations)
9,623.34
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.23
DAMD17-91-C-1139
P
Eq
3/1/02
300 Liter Formulation Tank
65,883.24
DAMD17-91-C-1139
P
Eq
3/1/02
Water for Injection (WFI) Capacity Improvement P
115,000.00
DAMD17-91-C-1139
P
Eq
3/29/02
SMA Portable Compressed Air Sampler
1,126.95
DAMD17-91-C-1139
P
Eq
3/29/02
Benchtop pH/temp/MV Meter (model 390)
1,221.57
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Standard Guinea Pig Unit
3,787.50
DAMD17-91-C-1139
P
Eq
3/29/02
Spot Insight Color C Mount Camera
3,877.43
DAMD17-91-C-1139
P
Eq
3/29/02
1240 Spectrophotometer
5,258.25
DAMD17-91-C-1139
P
Eq
3/29/02
Nikon E400 Microscope
6,541.78
DAMD17-91-C-1139
P
Eq
3/29/02
PR Wire/elx 405 VR Plate Washer & Reader
28,571.25
DAMD17-91-C-1139
P
Eq
3/29/02
D1 Water Skid
114,375.11
DAMD17-91-C-1139
P
Eq
3/29/02
PBX Telephone System
160,000.00
DAMD17-91-C-1139
P
Eq
3/29/02
Housing for Water for Injection Capacity PART B
1,110,980.00
DAMD17-91-C-1139
P
Eq
4/1/02
Security Gates in Tunnels
5,460.00
DAMD17-91-C-1139
P
Eq
4/1/02
Hollister Stier - Security System - Security Equipme
245,098.00
DAMD17-91-C-1139
P
Eq
4/12/02
Greenlee Bender
5,905.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
Lockable Cage
555.00
DAMD17-91-C-1139
P
Eq
5/1/02
X6000-Validation Reference Manual
750.00
DAMD17-91-C-1139
P
Eq
5/1/02
X6005-IQ/OQ Validation Protocols for Validator 2
1,500.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2020-ICAL Kit
1,600.00
DAMD17-91-C-1139
P
Eq
5/1/02
X0855-IRTD 400 High Accuracy Probe
3,730.00
DAMD17-91-C-1139
P
Eq
5/1/02
Sublot Transfer Cart
4,905.00
DAMD17-91-C-1139
P
Eq
5/1/02
Sublot Transfer Cart
4,905.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Eq
5/1/02
Building #29 Camera
8,105.00
DAMD17-91-C-1139
P
Eq
5/1/02
X200 Validator 2000 High Accuracy Validation Sy
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2000 Validator 2000-High Accuracy Validation S
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
X2000 Validator 2000-High Accuracy Validation S
13,360.00
DAMD17-91-C-1139
P
Eq
5/1/02
Guardhouse
58,750.00
DAMD17-91-C-1139
P
Eq
6/1/02
Honeywell Minitrend Data Recorder
7,250.20
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.46
DAMD17-91-C-1139
P
Eq
8/1/02
Standard Guinea Pig Unit
3,729.52
Eq
7,009,192.12
DAMD17-91-C-1139
P
Fu
9/1/93
Shelving
9,600.00
DAMD17-91-C-1139
P
Fu
4/1/00
Server Racks
3,814.04
DAMD17-91-C-1139
P
Fu
5/1/00
Tables & Chairs for Meeting Rooms
2,787.06
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
546.00
DAMD17-91-C-1139
P
Fu
8/1/00
Table and Chairs
636.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,678.28
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,949.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,953.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
1,983.05
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
2,077.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
2,543.00
DAMD17-91-C-1139
P
Fu
8/1/00
Office furniture
4,302.20
DAMD17-91-C-1139
P
Fu
8/1/00
Furniture
7,341.31
DAMD17-91-C-1139
P
Fu
8/1/00
Furniture
21,390.75
DAMD17-91-C-1139
P
Fu
10/1/00
Management Chair
541.87
DAMD17-91-C-1139
P
Fu
10/1/00
Office Furniture
2,120.00
DAMD17-91-C-1139
P
Fu
10/1/00
Office Furniture
2,120.00
DAMD17-91-C-1139
P
Fu
10/1/00
(13) Task Chairs, Paint and Carpet Squares
2,535.58
DAMD17-91-C-1139
P
Fu
12/1/00
10 Chairs
2,039.99
DAMD17-91-C-1139
P
Fu
12/1/00
Office Furniture
2,231.50
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
75.34
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
75.34
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
150.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.60
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Heather Blue Chair
192.68
DAMD17-91-C-1139
P
Fu
3/1/01
Furniture for AVA Trailer Project 178
9,487.82
DAMD17-91-C-1139
P
Fu
3/1/01
Cubicles for Workroom
13,141.98
DAMD17-91-C-1139
P
Fu
4/1/01
Building 29 Cubicles
25,383.55
DAMD17-91-C-1139
P
Fu
6/1/01
Marker Board
33.57
DAMD17-91-C-1139
P
Fu
6/1/01
Light Walnut Low Coffee Table
38.57
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Laminate Table
50.00
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Wood Guest Chair
54.28
DAMD17-91-C-1139
P
Fu
6/1/01
Cherry Wood Guest Chair
55.29
DAMD17-91-C-1139
P
Fu
6/1/01
Guest Chair
58.57
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Lateral File
100.00
DAMD17-91-C-1139
P
Fu
6/1/01
Big Man Chair
108.57
DAMD17-91-C-1139
P
Fu
6/1/01
Blue Superior Chair
158.57
DAMD17-91-C-1139
P
Fu
6/1/01
Desk National 30x60
258.58
DAMD17-91-C-1139
P
Fu
6/1/01
Conference Table
300.00
DAMD17-91-C-1139
P
Fu
6/1/01
Dark Walnut Desk
589.68
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.83
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.83
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
162.84
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
223.60
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
223.60
DAMD17-91-C-1139
P
Fu
7/1/01
Heather Blue Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Executive Chair
236.50
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
271.25
DAMD17-91-C-1139
P
Fu
7/1/01
Lateral File
271.25
DAMD17-91-C-1139
P
Fu
7/1/01
36 Bookcase
278.00
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
424.48
DAMD17-91-C-1139
P
Fu
7/1/01
4 Drawer Lateral File
620.00
DAMD17-91-C-1139
P
Fu
7/1/01
IS Storage Shelves
790.04
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.74
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Work Surface & Cubicle Area
2,577.75
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.97
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.97
DAMD17-91-C-1139
P
Fu
7/1/01
Office Furniture
3,000.98
DAMD17-91-C-1139
P
Fu
7/1/01
Building 29 Cubicles
15,622.62
DAMD17-91-C-1139
P
Fu
7/1/01
Document Control Fire Suppression System #1
48,321.30
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Blue Side Chair
103.00
DAMD17-91-C-1139
P
Fu
8/1/01
Wild Cherry Laminate Table
868.95
DAMD17-91-C-1139
P
Fu
9/1/01
System Wall w/Locking Doors
2,450.34
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
10/25/01
Shelving for Bldg 30 Coldroom
524.00
DAMD17-91-C-1139
P
Fu
12/1/01
Stainless Steel Cabinets
5,034.28
DAMD17-91-C-1139
P
Fu
12/1/01
Lockers
6,450.50
DAMD17-91-C-1139
P
Fu
12/1/01
Scientific Tables
7,167.15
DAMD17-91-C-1139
P
Fu
12/1/01
Security Office Storage
11,674.08
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
36 Bookcase
170.00
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.60
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.61
DAMD17-91-C-1139
P
Fu
1/31/02
60 Bookcase
418.61
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Equipment Stand
328.40
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Utility Cart
370.30
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Utility Cart
370.30
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Insurance Table
444.00
DAMD17-91-C-1139
P
Fu
4/1/02
Stainless Steel Insurance Table
444.00
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.89
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
6/1/02
FireKing Vertical Fire Cabinet
1,919.93
DAMD17-91-C-1139
P
Fu
7/1/02
Lateral Fireproof File Cabinet
2,024.00
DAMD17-91-C-1139
P
Fu
7/1/02
Lateral Fireproof File Cabinet
2,024.00
Fu
280,532.20
DAMD17-91-C-1139
R
Im
9/1/93
Security Doors
24,800.00
DAMD17-91-C-1139
R
Im
9/1/93
Coldroom Modular Facility
112,681.00
DAMD17-91-C-1139
R
Im
9/1/98
Backup generator
227,200.00
DAMD17-91-C-1139
R
Im
9/1/98
coldrooms (3A, 3B, 4)
230,000.00
DAMD17-91-C-1139
R
Im
8/1/00
Lab Renovations
8,108.00
DAMD17-91-C-1139
R
Im
10/1/00
Building 30 & Building 6 Roof
63,965.41
DAMD17-91-C-1139
R
Im
4/1/01
Building 29 Renovations
5,176.55
DAMD17-91-C-1139
R
Im
9/1/01
Fire Suppression IS
18,054.97
DAMD17-91-C-1139
R
Im
11/1/01
Paving Project
48,885.00
DAMD17-91-C-1139
R
Im
11/28/01
Perimeter Fence Building 15
1,749.00
DAMD17-91-C-1139
R
Im
11/28/01
Sheridan Rd Mechanical Slide Gate
35,196.00
DAMD17-91-C-1139
R
Im
12/1/01
Bullet Resistant Windows
30,845.00
DAMD17-91-C-1139
R
Im
12/1/01
Repairs to Domestic Water and Gas
92,349.00
DAMD17-91-C-1139
R
Im
1/1/02
Intercom System for Security Gates
17,600.00
DAMD17-91-C-1139
R
Im
1/1/02
Perimeter Fence Detection System
100,200.00
DAMD17-91-C-1139
R
Im
2/28/02
Coldroom 150 Temporary Loading Platform
83,881.22
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier - Security System - Fiber Cabling in :
2,730.00
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier-Security System - Reception Area Gh :
6,480.00
DAMD17-91-C-1139
R
Im
4/1/02
Hollister Stier-Security System - Campus Modific
24,868.00
DAMD17-91-C-1139
R
Im
5/1/02
Stainless Steel Razor Wire
20,978.00
DAMD17-91-C-1139
R
Im
6/1/02
Campus Lighting
4,923.00
DAMD17-91-C-1139
R
Im
6/1/02
Coldroom 150 Modifications
21,441.00
Im
1,182,111.15
DAMD17-91-C-1139
R
La
9/1/93
Tunnel Barricade
9,570.00
DAMD17-91-C-1139
R
La
9/1/93
Light pole lights, poles, conduit and wiring
20,000.00
DAMD17-91-C-1139
R
La
9/1/93
Pipe access covers
72,600.00
DAMD17-91-C-1139
R
La
9/1/93
Security fence
101,000.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-91-C-1139
R
La
9/1/98
Wooden fencing
8,413.00
DAMD17-91-C-1139
R
La
7/1/01
Tunnel Renovation
20,480.98
DAMD17-91-C-1139
R
La
9/1/01
Tunnel Barricade
14,361.35
La
246,425.33
DAMD17-91-C-1139
P
So
9/1/98
Date Acquisition System (Software and net packs)
36,765.00
DAMD17-91-C-1139
P
So
9/1/98
MRP-Fourth Shift Software Package
99,421.00
DAMD17-91-C-1139
P
So
3/1/00
Calhoun Computer System
1,699.96
DAMD17-91-C-1139
P
So
7/1/00
Seal Force Tester & Interface Software
12,675.00
DAMD17-91-C-1139
P
So
9/1/00
SAIP Compliance Software
212,153.00
DAMD17-91-C-1139
P
So
10/1/00
ABRA Suite Payroll Software
50,786.42
DAMD17-91-C-1139
P
So
9/1/01
Statistical Software
1,052.00
DAMD17-91-C-1139
P
So
10/9/01
STAT View Software
5,560.00
DAMD17-91-C-1139
P
So
10/12/01
Affirmative Action Plan (HR)
3,990.00
DAMD17-91-C-1139
P
So
1/31/02
Norton, Anti Virus Desk Server
7,653.75
DAMD17-91-C-1139
P
So
2/28/02
STAT View Software
6,500.00
DAMD17-91-C-1139
P
So
7/1/02
Office XP Property Licenses (60)
25,018.20
DAMD17-91-C-1139
P
So
8/1/02
Ghost Media Pack
2,884.00
DAMD17-91-C-1139
P
So
8/1/02
Office XP Property Licenses
20,875.00
DAMD17-91-C-1139
P
So
11/1/02
Network/Backup Archive System
99,232.59
So
586,265.92
DAMD17-91-C-1139
12,462,383.67
DAMD17-97-E-0004
P
Eq
9/1/89
Balance, Bench Top Model
1,503.00
DAMD17-97-E-0004
P
Eq
9/1/89
Bright Field Microscope
2,819.00
DAMD17-97-E-0004
P
Eq
9/1/89
Automated Kjeldahl Apparatus
24,400.00
DAMD17-97-E-0004
P
Eq
9/1/90
Holding Tank B, Train 2
67,883.66
DAMD17-97-E-0004
P
Eq
9/1/90
10 Liter Fermenter, Train 2
67,883.67
DAMD17-97-E-0004
P
Eq
9/1/90
100 Liter Fermenter, Train 2
67,883.67
DAMD17-97-E-0004
P
Eq
9/1/91
pH Meter
1,895.00
DAMD17-97-E-0004
P
Eq
9/1/91
Balance
2,625.50
DAMD17-97-E-0004
P
Eq
9/1/91
Balance
2,625.50
DAMD17-97-E-0004
P
Eq
9/1/91
CO2 Incubator
2,767.00
DAMD17-97-E-0004
P
Eq
9/1/91
Refrigerated Low Speed Centrifuge
17,113.00
DAMD17-97-E-0004
P
Eq
9/1/91
Autoclave
30,000.00
DAMD17-97-E-0004
P
Eq
9/1/91
100 Liter Fermenter, Train 1
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
10 Liter Fermenter, Train 3
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
100 Liter Fermenter, Train 4
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/91
10 Liter Fermenter, Train 4
102,900.00
Contract
P
Acquisition
Tax
Sys No
#
T
Class
Date
Description
Acq Value
DAMD17-97-E-0004
P
Eq
9/1/91
Autoclave, Double-door
128,350.00
DAMD17-97-E-0004
P
Eq
9/1/92
Holding Tank A, Train 3
102,900.00
DAMD17-97-E-0004
P
Eq
9/1/92
Holding Tank A, Train 4
102,500.00
DAMD17-97-E-0004
P
Eq
9/1/94
Hoist
575.00
DAMD17-97-E-0004
P
Eq
9/1/94
Hoist
575.00
DAMD17-97-E-0004
P
Eq
9/1/94
10 Liter Fermenter, Train 1
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/94
Holding Tank A, Train 2
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/94
100 Liter Fermenter, Train 3
71,610.00
DAMD17-97-E-0004
P
Eq
9/1/95
Two-Chart Recorder for Freezer #2
1,349.00
Eq
1,252,478.00
DAMD17-97-E-0004
R
Im
9/1/94
Stairs
1,000.00
Im
1,000.00
DAMD17-97-E-0004
1,253,478.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
DAMD17-98-C-8052
P
Eq
9/1/98
Holding Tank
62,500.00
Eq
250,000.00
DAMD17-98-C-8052
250,000.00
13,965,861.67
Attachment 3
Page 1 of 1
Jan
Feb
Mar
Apr
May
June
July
Aug
Sep
Oct
Nov
Dec
Total
0
0
0
108,120
108,120
108,120
108,120
108,120
108,120
108,120
108,120
108,120
973,080
235,880
235,880
235,820
127,760
127,760
127,760
127,760
127,760
127,760
127,760
127,760
127,730
1,857,390
115,000
115,000
115,000
115,000
115,000
115,000
115,000
115,000
114,930
1,034,930
3,865,400
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00001 20-Jan-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCMA GRAND RAPIDS RIVERVIEW CENTER BUILDING 678 FRONT STREET, NW GRAND RAPIDS, MI 49504-5352 US ARMY SPACE & MISSILE DEFENSE COMMAND SMDC-CM-CB / MS. OCONNELL 301-819-2895 64 THOMAS JOHNSON DRIVE FREDERICK, MD 21702 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP Code) BIOPORT CORPORATION 3400 N. MARTIN LUTHER KING JR. BLVD LANSING, MI 48906 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MOD OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 08-Jan-2004 CODE 1H086 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, X appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return ___copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) See Attached Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) LYNN M. SELFRIDGE//CONTRACTING OFFICER 15A. NAME AND TITLE OF SIGNER (Type or print) TEL: 301-619-2707 EMAIL: lynn.selfridge@DET.AMEDO.ARMY.MIL 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA BY /s/ Lynn M. Selfridge 16C. DATE SIGNED 15C. DATE SIGNED 22-JAN-2004 (Signature of person authorized to sign) (Signature of Contracting Officer) STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00002 2-Sep-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS RIVERVIEW CENTER BUILDING 678 FRONT STREET, NW GRAND RAPIDS, MI 49504-5352 US ARMY SPACE & MISSILE DEFENSE COMMAND SMDC-CM-CB / MS. SELFRIDGE 301-619-2707 64 THOMAS JOHNSON DRIVE FREDERICK, MD 21702 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) BIOPORT CORPORATION 3500 N. MARTIN LUTHER KING, JR. BLVD LANSING, MI 48906 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HDB6 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER (Specify type of modification and authority) X FAR52.217-9 E. IMPORTANT: Contractor is not, is required to sign this document and return ___copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Exercise Option Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) LYNN SELFRIDGE, / CONTRACTING OFFICER 15A. NAME AND TITLE OF SIGNER (Type or print) TEL: 301-619-2707 EMAIL: lynn.selfridge@DET.AMEDD.ARMY.MIL 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA BY /s/ Lynn M. Selfridge 16C. DATE SIGNED (Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) 2-Sep-2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1 4 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) P00003 09/28/04 N/A N/A - 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command Attn: SMDC-CM-CB DCMA Detroit-Grand Rapids 64 Thomas Johnson Drive 678 Front Avenue, NW Fredrick, MD 21702 Grand Rapids, MI 49504-5352 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation, Inc. 3500 Martin Luther King Jr., Blvd. Lansing, MI 48906 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002 10B. DATED (SEE ITEM 11) 01/04/04 CODE 1H0B6 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment, your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER CHECK ONE NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER (Specify type of modification and authority) X PL 85-804, Implemented by FAR 50.403-2(b) and MoD dated Sep. 28, 2004 E. IMPORTANT: Contractor is not, is required to sign this document and return ___copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) See Attached. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE 15B. CONTRACTOR/OFFEROR 1 6B. UNITED STATES OF AMERICA /s/ Lynn M. Selfridge 16C. DATE SIGNED (Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) 09/28/04 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
A. | This modification incorporates the full text FAR clause 50.250-1 entitled Indemnification under Public Law 85-804 into contract number W9113M-04-D-0002 and is added to Section I. |
B. | The Memorandum of Decision signed by the Acting Secretary of the Army on September 28, 2004, is incorporated into Section J of the contract as Attachment Number 4, 3 pages. The definition of unusually hazardous risk applicable to this contract is delineated in TAB A to the Memorandum of Decision. |
C. | This modification is executed without cost to either party and is without effect to any other contract terms or conditions comprising contract W9113M-04-D-0002. |
(1) | All or substantially all of the Contractors business; | ||
(2) | All or substantially all of the Contractors operations at any one plant or separate location in which this contract is being performed; or | ||
(3) | A separate and complete major industrial operation in connection with the performance of this contract. |
(1) | Claims (including reasonable expenses of litigation or settlement) by third persons (including employees the Contractor) for death; personal injury; or loss of, damage to, or loss of use of property; | ||
(2) | Loss of, damage to, or loss of use of Contractor property, excluding loss of profit; and | ||
(3) | Loss of, damage to, or loss of use of Government property, excluding loss of profit. |
(1) | arises out of or results from a risk defined in this contract as unusually hazardous or nuclear and | ||
(2) | is not compensated for by insurance or otherwise. | ||
Any such claim, loss, or damage, to the extent that it is within the deductible amounts of the Contractors insurance, is not covered under this clause. If insurance coverage or other financial protection in effect on the date the approving official authorizes use of this clause is reduced, the Governments liability under this clause shall not increase as a result. |
(1) | Government claims against the Contractor (other than those arising through subrogation); or | ||
(2) | Loss or damage affecting the Contractors property. |
(1) | Promptly notify the Contracting Officer of any claim or action against, or any loss by, the Contractor or any subcontractors that may be reasonably be expected to involve indemnification under this clause; | ||
(2) | Immediately furnish to the Government copies of all pertinent papers the Contractor receives; | ||
(3) | Furnish evidence or proof of any claim, loss, or damage covered by this clause in the manner and form the Government requires; and | ||
(4) | Comply with the Governments directions and execute any authorizations required in connection with settlement or defense of claims or actions. |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES J 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. POOOO4 26-Oct-2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W90GXK 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS CHEMICAL-BIOLOGICAL-MEDICAL SYSTEMS PMO RIVERVIEW CENTER BUILDING 64 THOMAS JOHNSON DRIVE 678 FRONT STREET, NW FREDERICK MD 21702 GRAND RAPIDS MI 49504-5352 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP Code) BIOPORT CORPORATION 3500 N MARTIN LUTHER KING JR BLVD LANSING MI 48906 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) (X) 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 (X) 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HOB6 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X Mutual Agreement - D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Add new contract line items for Pentavalent Bot annual testing. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force a nd effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE / CONTRACTING OFFICER Robert Kramer, President & CEO TEL: 301-619-2707 EMAIL: Lynn.Selfridge@DET.AMEDO.ARMY.MIL 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert Kramer BY /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 11/12/04 (Signature of Contracting Officer) 03-Nov-2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
ITEM NO | SUPPLIES/SERVICES | QUANTITY | UNIT | UNIT PRICE | MAX AMOUNT | |||||||||||||||
0004 |
|
1 | $ | 52,324.00 | $ | 52,324.00 | ||||||||||||||
Pentavalent Botulinum Testing
FFP Conduct Pentavalent Botulinum Long-Term Interval Testing for lots PBP003 and PBP0004 using Protocol Numbers LTIT2003-001 and LTIT2003-002 |
||||||||||||||||||||
|
||||||||||||||||||||
NET AMT
|
$ | 52,324.00 | ||||||||||||||||||
Funded Amount
|
$ | 0.00 |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY | |||
N/A
|
N/A | N/A | Government |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 5 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. P00005 Nov 16 2004 W90GXK33010005 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE W90GXK 7. ADMINISTERED BY (If other than Item 6) CODE S2303A DCM GRAND RAPIDS CHEMICAL-BIOLOGICAL-MEDICAL SYSTEMS PMO RIVERVIEW CENTER BUILDING 64 THOMAS JOHNSON DRIVE 678 FRONT STREET, NW FREDERICK MD 21702 GRAND RAPIDS MI 49504-5352 8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP Code) BIOPORT CORPORATION 3500 N MARTIN LUTHER KING JR BLVD LANSING MI 48906 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 X 10B. DATED (SEE ITEM 13) 06-Jan-2004 CODE 1HOB6 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X Mutual Agreement - D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Revise quantity of CLIN 0004 in P00004 dated November 3, 2004 from 1 test to 2 tests, and to increase the total value of CLIN 0004 to $104,648. The Statement of Work Paragr aph C.1.4.b. is revised to read: All testing other than Pentavalent Botulinum Vaccine.... as included on the attached SOW. FAR 52.216-19 and FAR 52.232-32 of the contract are not applicable to CLIN 0004. Funding will be provided on individual delivery orders. All other terms and conditions of the contract remain unchanged and in full force and effect. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) 15A. NAME AND TITLE OF SIGNER (Type or print) LYNN M. SELFRIDGE Robert Kramer, President & CEO TEL: EMAIL: 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA By /s/ Robert Kramer BY_/s/ Lynn M. Selfridge___ 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 11/12/04 (Signature of Contracting Officer) Nov 16, 2004 STANDARD FORM 30 (REV. 10-83) EXCEPTION TO SF 30 Prescribed by GSA APPROVED BY OIRM 11-84 30-105-04 FAR (48 CFR) 53.243 |
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES - 1. CONTRACT ID CODE 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) P00006 01/04/04 N/A N/A 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2101A U.S. Army Space and Missile Defense Command ATTN: SMDC-CM-CB DCMA Detroit-Grand Rapids 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation 3500 N. Martin Luther King, Jr. Blvd Lansing, MI 48906 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. W9113M-04-D-0002 10B. DATED (SEE ITEM 11) 01/02/04 CODE FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) Not applicable 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER CHECK ONE NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X FAR 52.212-4 (c) D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) See Page 2. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Robert G. Kramer, President & CEO Lynn M. Selfridge 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/3/05 (Signature of Contracting Officer) 2/8/05 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
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(1) | Maintain current level of security at BioPorts production facility in Lansing, MI that is used to produce and store the Governments purchase of Anthrax Vaccine Adsorbed. | ||
(2) | Printing labels, labeling of vials and packaging for shipment of AVA produced under this contract. | ||
(3) | Potency testing on stability lots produced under this contract. | ||
(4) | Stability test consisting of chemistry, sterility, and safety, on the doses produced under this contract: |
Contract Line Item No. | Old Price/dose | Adjusted Price/dose | ||||||
0001
|
$ | [**] | $ | [**] | ||||
0002
|
$ | [**] | $ | [**] | ||||
0003
|
$ | [**] | $ | [**] |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 01 02/16/05 N/A N/A 6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command DCMA Grand Rapids ATTN: SMDC-CM-CB Riverview Center Building 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504-5352 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation 3500 N. Martin Luther King Jr. Blvd Lansing, MI 48906 (X) 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002-0001 10B. DATED (SEE ITEM 11) 01/02/04 CODE 1HNOB6 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) See Block 14, below. 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER CHECK ONE NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X FAR 52.212-4 D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) This instrument modifies delivery order number 0001 issued under the provisions of contract W9113M-04-D-0002, as a result of contract modification P00006 dated February 8, 2005. The price per dose of the commercially available anthrax vaccine (the DoDs Anthrax Vaccine Adsorbed) is increased to cover the additional expense for labels, labeling, packaging for shipment, stability testing, potency testing, and the provision of security at the BioPort Lansing, MI facility. The revised dose price is $[**]. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Robert G. Kramer, President & CEO Lynn M. Selfridge 15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/17/05 (Signature of Contracting Officer) 2/17/05 NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
ITEM NO | SUPPLIES | MIN QTY | UNIT | UNIT PRICE | AMOUNT | |||||||||||||||
0001
|
AVA Vaccine | [**] | Dose | $ | [**] | $ | 32,408,552.40 |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES |
1 2 |
2. AMENDMENT/MODIFICATION NO 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 01 02/16/05 N/A N/A |
6. ISSUED BY CODE W9113M 7. ADMINISTERED BY (If other than Item 6) CODE S2303A U.S. Army Space and Missile Defense Command DCMA Grand Rapids ATTN: SMDC-CM-CB Riverview Center Building 64 Thomas Johnson Drive 678 Front Street, NW Frederick, MD 21702 Grand Rapids, MI 49504-5352 |
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation 3500 N. Martin Luther King Jr. Blvd Lansing, MI 48906 (X) 9A. AMENDMENT OF SOLICITATION NO. |
9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. X W9113M-04-D-0002-0002 10B. DATED (SEE ITEM 11) 01/02/04 CODE 1HOB6 FACILITY CODE |
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: |
(a) By completing items 8 and 1 5, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) See Block 14, below. 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . |
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER CHECK ONE NO. IN ITEM 10A. |
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: |
X FAR 52.212-4 |
D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) This instrument modifies delivery order number 0002 issued under the provisions of contract W9113M-04-D-0002, as a result of contract modification P00006 dated February 8, 2005. The price per dose of the commercially available anthrax vaccine (the DoDs Anthrax Vaccine Adsorbed) is increased to cover the additional expense for labels, labeling, packaging for shipment, stability testing, potency testing, and the provision of security at the BioPort Lansing, MI facility. The revised dose price is $[**]. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Robert G. Kramer, President & CEO Lynn M. Selfridge |
15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer /s/ Lynn M. Selfridge 15C. DATE SIGNED 16C. DATE SIGNED (Signature of person authorized to sign) 2/17/05 (Signature of Contracting Officer) 2/17/05 |
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243
|
ITEM NO | SUPPLIES | MIN QTY | UNIT | UNIT PRICE | AMOUNT | |||||||||||||||
0002
|
AVA Vaccine | [**] | Dose | $ | [**] | $ | 36,870,814.50 |
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. |
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24 & 30 1. REQUISITION NUMBERExhibit 10.9 |
| | | | | | | | | | | | | | | | | | | PAGE 1 OF 10 3. AWARD / EFFECTIVE 6 . SOLICITATION 2. CONTRACT NO. DATE 5. SOLICITATION NUMBER ISSUE DATE 200-2005-11811 See Block 31c 4. ORDER NUMBER 2005-B-01697 01/05/2005 8. OFFER DUE DATE/ a . NAME b. TELEPHONE NUMBER (no collect calls) LOCAL TIME 7. FOR SOLICITATION INFORMATION CALL: Linda Williams (770) 488-2692 02/01/2005 10. THIS ACQUISITION IS UNRESTRICTED 12. DISCOUNT TERMS 9. ISSUED BY SET ASIDE: % FOR SEE SCHEDULE Department of Health and Human Services SMALL BUSINESS 13a. THIS CONTRACT IS A RATED ORDER Office of Public Health Emergency Preparedness SMALL DISADV. BUSINESS UNDER DPAS (15 CFR 700) Office of Research and Development Coordination 8(A) 13b. RATING 200 Independence Avenue, SW, Room 636G SIC: 14. METHOD OF SOLICITATION Washington, DC 20201 CODE SIZE STANDARD: RFQ IFB X RFP Williams 16. ADMINISTERED BY Centers for Disease Control and Prevention (PGO) 15. DELIVER TO Acquisition & Assistance Branch 8, Team 1 SEE C.1.1 2920 Brandywine Road, Room 3120 SMALL BUSINESS CODE Atlanta, GA 30341-5539 CODE 2536 CODE 18a. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention (FMO) P.O. Box 15580 (404) 498-4050 Atlanta, GA 30333 BioPort Corporation 3500 North Martin Luther King, Jr. Blvd. Lansing, MI 48906 TIN: 38-3412788 TELEPHONE NO. (301) 590-0129 ext. 518 Robert Shumate ITEM SUPPLIES / SERVICES QTY 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18A UNLESS BLOCK BELOW 17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER SEE ADDENDUM 19. 20. 21. 22. 23. 24. ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT See Continuation Page (Attach Additional Sheets as Necessary) |
25. ACCOUNTING AND APPROPRIATION DATA Appropriation: 7550140 CAN: 921Z02A OCC: 2641 26. TOTAL AWARD AMOUNT (For Govt. Use Only) Allowance: A2AYS Amount: $122,737,000.00 $122,737,000.00 |
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27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED. 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED. 28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES 29. AWARD OF CONTRACT: REFERENCE OFFER TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET DATED . YOUR OFFER ON SOLICITATION (BLOCK 5), FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH TO THE TERMS AND CONDITIONS SPECIFIED HEREIN. HEREIN, IS ACCEPTED AS TO ITEMS: |
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30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a . UNITED STATES OF AMERICA (Signature of Contracting Officer) /s/ Robert G. Kramer /s/ Lorenzo J. Falgiano 30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b . NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED Robert G. Kramer, President & CEO 5/5/05 Lorenzo J. Falgiano May 05 2005 |
32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER RECEIVED INSPECTED PARTIAL FINAL 34. VOUCHER NUMBER |
32b. SIGNATURE OF AUTHORIZED GOVT REPRESENTATIVE 32c. DATE 41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT 36 . PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE COMPLETE PARTIAL FINAL 37. CHECK NUMBER |
38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY 42a. RECEIVED BY (Print) |
42b. RECEIVED AT (Location ) 42c. DATE RECD 42d. TOTAL CONTAINERS AUTHORIZED FOR LOCAL REPRODUCTION SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95) |
Section |
Document/Clause/Provision
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Page No. | ||||
A |
Standard Form 1449
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1 | ||||
B |
Continuation of SF1449 (Block 19 24)
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2 | ||||
C |
Contract Clauses
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3 | ||||
D |
Contract Documents, Exhibits or Attachments
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9 |
Page i
ITEM NO. | SUPPLIES / SERVICES | QTY / UNIT | UNIT PRICE | EXTENDED PRICE | ||||||
0001
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BioThrax Vaccine | [**] Doses | $[**] | $ | 75,237,000.00 | |||||
|
Anthrax Vaccine Adsorbed (AVA) | |||||||||
|
BioThrax ® |
ITEM NO. | SUPPLIES / SERVICES | QTY / UNIT | UNIT PRICE | EXTENDED PRICE | ||||||
0002
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BioThrax Vaccine | [**] | $[**] | $ | 47,500,000.00 | |||||
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Anthrax Vaccine Adsorbed (AVA) | Doses | ||||||||
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BioThrax ® |
ITEM NO. | SUPPLIES / SERVICES | QTY / UNIT | UNIT PRICE | EXTENDED PRICE | ||||
0003
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BioThrax Vaccine | 5,000,000 | TBD | TBD* | ||||
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Anthrax Vaccine Adsorbed (AVA) | Doses | ||||||
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BioThrax ® |
* | Following execution of the contract, the government agrees to meet with the contractor to discuss an option to procure 5 million additional doses of AVA. Since the option price nor the performance period has been agreed upon at contract execution the clauses found at FAR 52.217-7 and 52.217-9 are not included. |
TOTAL: 5,000,000 Doses
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$ | 122,737,000.00 | ||
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Page 2
FAR SOURCE
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TITLE AND DATE | |
52.212-4
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Contract Terms and Conditions Commercial Items (Oct 2003) | |
52.243-1
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Changes Fixed Price | |
52.247-30
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F.O.B. Origin, Contractors Facility |
a. | Delivery of the BioThrax Vaccine shall be F.O.B.Origin, Contractors Facility. | ||
b. | The USG will receive and transport product from the manufacturer monthly, on or about the 15 th of each month or such mutually acceptable date, during the life of the contract. | ||
c. | Inspection/Acceptance: Prior to acceptance of the product by the Strategic National Stockpile (SNS), the contractor shall provide approximately 2 week advanced notification of the amount of product that will be available, so that the USG may plan for the necessary logistics. Notice of availability of product with supporting documentation shall be provided to the Project Officer, Walter Lange at (202)401-4848. | ||
d. | Acceptance of the product shall be deemed to have occurred after USG inspection and in accordance with C.1.2 below, and upon delivery of the FDA-released product to the USG designated carrier on the monthly transport date as provided in (b.) above. Contractor will invoice the USG immediately upon acceptance. |
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(a) | The Contractor shall submit an original and one (1) copy of contract invoices to the address shown below: | |
Centers for Disease Control and Prevention
Procurement and Grants Office Attn: Linda F. Williams, Contract Specialist 2920 Brandywine Road, Room 3120 Atlanta, Ga. 30341 |
Page 10
(b) | The contractor shall submit one (1) copy of each invoice to our Financial Management Office: | |
Centers for Disease Control and Prevention
FMO PO Box 15580 Atlanta, GA 30333 |
(c) | The Contractor agrees to include (as a minimum) the following information on each invoice: | |
(1) Contractors Name & Address | ||
(2) Contractors Tax Identification Number (TIN) | ||
(3) Contract Number | ||
(4) Invoice Number | ||
(5) Invoice Date | ||
(6) Contract Line Item Number | ||
(7) Quantity | ||
(8) Unit Price & Extended Amount for each line item | ||
(9) Total Amount of Invoice | ||
(10) Name, title and telephone number of person to be notified in the event of a defective invoice | ||
(11) Payment Address or Electronic Funds Transfer (EFT) banking information. | ||
(12) Material Receiving Report Signed by USG Representative. |
Page 11
Item | Description | Attachment | ||
1
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Statement of Work | D.1 | ||
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2
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BioPort Load Plan | D.2 | ||
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3
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ACH Vendor/Miscellaneous Payment | D.3 | ||
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Enrollment Form |
Page 12
(1) | Monthly Progress Reports: On the fifteenth of each month for the previous calendar month, the Contractor shall submit a Monthly Progress Report to the Project Officer and the Contracting Officer. A monthly report will not be required for the period when the final report is due. The Contractor shall submit one copy of the Monthly Progress Report electronically via e-mail. Any attachments to the e-mail report shall be submitted in Microsoft Word or WordPerfect 9 or compatible version. Such reports shall include the following specific information: | ||
a. | The contract number and title, the period of performance being reported, the contractors name and address, the author(s), and the date of submission; | ||
b. | Section I An introduction covering the purpose and scope of the contract effort; | ||
Section II The report shall detail, document, and summarize the results of work done in performance of requirements of this contract during the period covered, and include a summary of work planned for the next reporting period. This shall include the information listed below that is applicable for the performance period during the month being reported: | |||
Production capacity assessment problems and recommendations to include: | |||
1. Raw material procurement status; | |||
2. Inventory report of product manufactured and delivered to the USG under this contract. | |||
3. Quality control testing and purity; | |||
4. Quality control potency assessment; | |||
5. FDA inspections and consultation results or recommendations; | |||
6. Security assessment, problems and recommendations; | |||
7. Physical storage monitoring and calibration reports for manufactured products. | |||
8. Overall project assessment, problems encountered and recommended solutions, etc. |
Attachment D.3, Contract No. 200-2005-11811 | OMB No. 1510-0056 |
AGENCY INFORMATION
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FEDERAL PROGRAM AGENCY
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AGENCY IDENTIFIER:
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AGENCY LOCATION CODE (ALC): | ACH FORMAT: | ||||||
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o CCD+ o CTX | |||||||
ADDRESS:
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CONTACT PERSON NAME:
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TELEPHONE NUMBER: | |||||||
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( ) | |||||||
ADDITIONAL INFORMATION:
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PAYEE/COMPANY INFORMATION
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NAME
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SSN NO. OR TAXPAYER ID NO.
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ADDRESS
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CONTACT PERSON NAME:
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TELEPHONE NUMBER: | |||
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( ) | |||
AUTHORIZED FOR LOCAL REPRODUCTION | SF 3881 (Rev. 2/2003) | |
Prescribed by Department of Treasury | ||
31 U S C 3322; 31 CFR 210 |
1. | Agency Information Section - Federal agency prints or types the name and address of the Federal program agency originating the vendor/miscellaneous payment, agency identifier, agency location code, contact person name and telephone number of the agency. Also, the appropriate box for ACH format is checked. |
2. | Payee/Company Information Section - Payee prints or types the name of the payee/company and address that will receive ACH vendor/miscellaneous payments, social security or taxpayer ID number, and contact person name and telephone number of the payee/company. Payee also verifies depositor account number, account title, and type of account entered by your financial institution in the Financial Institution Information Section. |
3. | Financial Institution Information Section - Financial institution prints or types the name and address of the payee/companys financial institution who will receive the ACH payment, ACH coordinator name and telephone number, nine-digit routing transit number, depositor (payee/company) account title and account number. Also, the box for type of account is checked, and the signature, title, and telephone number of the appropriate financial institution official are included. |
PAGE OF PAGES AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE 1 1 2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 00001 See Block 16c 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable) 6. ISSUED BY CODE 2536 7. ADMINISTERED BY (If other than Item 8) CODE Centers for Disease Control and Prevention (PGO) Acquisition & Assistance Branch 8, Team 1 2920 Brandywine Road, Room 3120 Atlanta, GA 30341-5539 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) 9A. AMENDMENT OF SOLICITATION NO. BIOPORT CORPORATION 3500 N. MARTIN LUTHER KING, JR. BLVD. LANSING, MI 48906-2933 9B. DATED (See Item 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. 200-2005-11811 X 10B. DATED (See Item 13) CODE 0 26489018 FACILITY CODE 05/05/2005 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers ___is extended, ___is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. |
12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A |
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). |
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X Contract Clause C.4 Indemnification |
D. OTHER (Specify type of modification and authority) |
E. IMPORTANT: Contractor is not, x is required to sign this document and return 1 copies to the issuing office. |
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) The purpose of this modification is to: (1) indemnify the contractor pursuant to the attached memorandum of decision, signed by the Secretary of Department of Health and Human Services. (2) The indemnification agreement is hereby incorporated into the contract. (3) As a result of items (1) and (2) above, the contract price and performance period remain unchanged. (4) all other terms and conditions of the contract remain unchanged and in full force and effect. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. |
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME OF CONTRACTING OFFICER Robert G. Kramer Joe G. Little, Jr. |
15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer BY /s/ Joe G. Little, Jr. 15C. DATE SIGNED 16C. DATE SIGNED (signature of person authorized to sign) 2/23/06 (Signature of Contracting Officer) 02/23/2006 |
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GBA FAR (48 CFR) 53.243 |
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/s/ Michael O. Leavitt | |
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Michael O. Leavitt |
3
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 1 |
2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 00001 See Block 16c 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable) |
6. ISSUED BY CODE 2536 7. ADMINISTERED BY (If other than Item 8) CODE |
Centers for Disease Control and Prevention (PGO) Acquisition & Assistance Branch 8, Team 1 2920 Brandywine Road, Room 3120 Atlanta, GA 30341-5539 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) 9A. AMENDMENT OF SOLICITATION NO. BIOPORT CORPORATION 3500 N. MARTIN LUTHER KING, JR. BLVD. LANSING, MI 48906-2933 9B. DATED (See Item 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. 200-2005-11811 X 10B. DATED (See Item 13) CODE 0 26489018 FACILITY CODE 05/05/2005 |
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers ___is extended, ___is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. |
12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A |
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). |
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X Contract Clause C.4 Indemnification |
D. OTHER (Specify type of modification and authority) |
E. IMPORTANT: Contractor is not, x is required to sign this document and return 1 copies to the issuing office. |
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) The purpose of this modification is to: (1) indemnify the contractor pursuant to the attached memorandum of decision, signed by the Secretary of Department of Health and Human Services. (2) The indemnification agreement is hereby incorporated into the contract. (3) As a result of items (1) and (2) above, the contract price and performance period remain unchanged. (4) all other terms and conditions of the contract remain unchanged and in full force and effect. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. |
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME OF CONTRACTING OFFICER Robert G. Kramer Joe G. Little, Jr. |
15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA /s/ Robert G. Kramer BY /s/ Joe G. Little, Jr. 16C. DATE SIGNED (signature of person authorized to sign) 2/23/06 (Signature of Contracting Officer) 02/23/2006 |
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GBA FAR (48 CFR) 53.243 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 3 2. AMENDMENT/MODIFICAITON NO. Modification 00003 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicble) |
6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE Department of Health & Human Services OS/OPHEP/ORDC 200 Independence Ave., S.W. Room 636G Washington, D.C. 20201 |
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) BioPort Corporation 3500 N. Martin Luther King, Jr. Blvd. Lansing, MI 48906-2933 (X) 9A. AMENDMENT OF SOLICIATION NO. |
9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100200600019C 10B. DATED (SEE ITEM 11) 05/05/05 CODE FACILITY CODE |
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS |
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 15, and returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. |
12. ACCOUNTING AND APPROPIRATION DATA (If required) TIN: 383412788 CAN: 1991535 Appropriation: 7560140 O.C. 25.2A $120,000,000.00 |
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14 . |
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER CHECK ONE NO. IN ITEM 10A. |
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). |
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X FAR 52.243-1, Changes |
D. OTHER (Specify type of modification and authority) |
E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. |
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) The purpose of this modification is to modify the statement of work, apply the indemnification to the modified contract number, and purchase an additional 5 million doses of AVA as reflected on page 2 through 3. 1. The total contract amount is increased by $120,000,000 from $122,737,000 to $242,737,000 2. The total allotted amount is increased by $120,000,000 from $122,737,000 to $242,737,000 3. The contract period of performance is extended from September 30, 2006 to September 30, 2007. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. |
15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Robert G. Kramer, President & CEO Brian K. Goodger |
15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED /s/ Robert G. Kramer 5/4/06 /s/ Brian K. Goodger 5/4/06 |
(Signature of person authorized to sign) (Signature of Contracting Officer) |
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243 |
HHSO100200600019C, modification 3 | BioPort |
ITEM NO. | SUPPLIES / SERVICES | QTY / UNIT | UNIT PRICE | EXTENDED PRICE | ||||||
0004 |
BioThrax Vaccine
Anthrax Vaccine Adsorbed (AVA) BioThrax® |
5,000,000
Doses |
$[**]
FFP |
$ | 120,000,000.00 | |||||
|
||||||||||
TOTAL: 5,000,000 Doses | $ | 120,000,000.00 |
b. | The USG will receive and transport product from the manufacturer approximately bi-monthly. A first delivery of approximately [**] doses shall be available for inspection and acceptance immediately after award of the contract modification. The contractor shall invoice and be paid upon acceptance of the first delivery. Upon acceptance of the first delivery at the manufacturers location, the manufacturer shall store the USG vaccine in cGMP conditions in segregated storage until the first scheduled shipment on or about August 15. Subsequent deliveries and shipments shall occur as follows: |
Target Quantities to be | Target Quantities to be | |||
Delivered (Inspection | Shipped to SNS | |||
Estimated Delivery Dates | and Acceptance) | Location | ||
Immediately after Contract Award
|
[**] | [**] | ||
August 15, 2006
|
[**] [**] | [**] [**] | ||
October 15, 2006
|
[**] [**] | [**] [**] | ||
December 16, 2006
|
[**] [**] | [**] [**] | ||
February or March, 2007
(balance to be delivered by May
5, 2007 at the latest)
|
[**] [**] | [**] [**] |
d. | Except for the acceptance of the first delivery, acceptance of the product shall be deemed to have occurred after USG inspection and in accordance with C.1.2, and upon delivery of the FDA-released product to the USG designated carrier on the periodic transport dates as provided in (b.) above. Contractor will invoice the USG immediately upon acceptance. | ||
(End of Clause) |
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HHSO100200600019C, modification 3 | BioPort |
(a) | The Contractor shall submit an original and one (1) copy of contract invoices to the address shown below: |
Item | Description | Attachment | ||
1 |
Revised Statement of Work (modified on page 2,
Task 1)
|
D.1, 3 pages |
Page 3
HHSO100200600019C, modification 3 | BioPort |
1
HHSO100200600019C, modification 3 | BioPort |
a) | The Contractor shall manufacture AVA in accordance with current GMP guidelines. The Contractor shall deliver 5 million doses of Final Drug Product (FDP) in 5 mL multi-dose vials, to the SNS by May 5, 2007. No lots shall be accepted that have an expiration date before December 7, 2008. | ||
b) | The Contractor shall provide primary and secondary points of contact who will be available 24 hours per day, seven days per week to be notified in case of a public health emergency. |
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HHSO100200600019C, modification 3 | BioPort |
(1) | Monthly Progress Reports: On the fifteenth of each month for the previous calendar month, the Contractor shall submit a Monthly Progress Report to the Project Officer and the Contracting Officer. A monthly report will not be required for the period when the final report is due. The Contractor shall submit one copy of the Monthly Progress Report electronically via e-mail. Any attachments to the e-mail report shall be submitted in Microsoft Word or WordPerfect 9 or compatible version. Such reports shall include the following specific information: | ||
a. | The contract number and title, the period of performance being reported, the contractors name and address, the author(s), and the date of submission; | ||
b. | Section I An introduction covering the purpose and scope of the contract effort; | ||
Section II The report shall detail, document, and summarize the results of work done in performance of requirements of this contract during the period covered, and include a summary of work planned for the next reporting period. This shall include the information listed below that is applicable for the performance period during the month being reported: | |||
Production capacity assessment problems and recommendations to include:
|
1. | Raw material procurement status; | ||
2. | Inventory report of product manufactured and delivered to the USG under this contract. | ||
3. | Quality control testing and purity; | ||
4. | Quality control potency assessment; | ||
5. | FDA inspections and consultation results or recommendations; | ||
6. | Security assessment, problems and recommendations; | ||
7. | Physical storage monitoring and calibration reports for manufactured products. | ||
8. | Overall project assessment, problems encountered and recommended solutions, etc. |
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1.0 | Definitions: As used in this agreement, the following definitions shall apply: |
1.1 | Act shall mean the US Food, Drug and Cosmetic Act of 1934, and the regulations promulgated thereunder, as the same may be amended from time to time. | ||
1.2 | Bulk Lot shall mean each separate and distinct quantity of Bulk Product designated as a single batch or lot by BIOPORT and designated by lot number. | ||
1.3 | Bulk Product shall mean AVA in bulk form as manufactured by BIOPORT and shipped to HOLLISTER-STIER. | ||
1.4 | Bulk Product Specification(s) means the specifications for the composition, testing, packaging and labeling of the Bulk Product. | ||
1.5 | Certificate of Analysis and COA shall mean a document prepared in accordance with cGMP and certifying that a Filled Lot meets the Filling Process Specifications as referenced, signed and dated by a duly authorized representative of the Quality Assurance Department of HOLLISTER-STIER. | ||
1.6 | cGMP shall mean current Good Manufacturing Practices as such term is used in the Act. |
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1.7 | Confidential Information shall mean any nonpublic information of BIOPORT that has been or will be communicated to HOLLISTER-STIER or any nonpublic information of HOLLISTER-STIER that has been or will be communicated to BIOPORT, including without limitation, trade secrets, business methods, operating procedures, manufacturing methods and processes, prices, product forecasts, actual orders, and customer information, whether in a written, oral or visual format; provided, however, that Confidential Information will not include any information that is: (a) already known to the receiving Party at the time of disclosure hereunder, as demonstrated by its written records; (b) now or hereafter becomes publicly known other than through acts or omissions of the receiving Party, or anyone to whom the receiving Party disclosed such information; (c) disclosed to the receiving Party on a nonconfidential basis by a third party under no obligation of confidentiality to the disclosing Party; or (d) independently developed by the receiving Party without reliance on the Confidential Information of the disclosing Party as shown by its written records. | ||
1.8 | FDA shall mean the United States Food and Drug Administration. | ||
1.9 | Filled Lot shall mean each separate and distinct quantity of Filled Product processed under continuous conditions from a [**] Bulk Lot and that is designated as a single batch or lot by HOLLISTER-STIER and designated by a lot number. | ||
1.10 | Filled Product shall mean vials filled by HOLLISTER-STIER with Bulk Product in accordance with all Filling Process Specifications and other requirements of this Agreement. | ||
1.11 | Filling Process Specification(s) means the requirements and statement of procedures for filling, testing, packaging, labeling, storage, and shipping Filled Product, as set forth in [**], as altered or amended pursuant to Section 4.12. The Filling Process Specifications do not include matters covered by the Bulk Product Specifications. | ||
1.12 | Good Faith Annual Estimate shall have the meaning described in Section 5.2. | ||
1.13 | Health Authority means a regulatory authority having jurisdiction over the manufacture or sale of Bulk Product or Filled Product, including but not limited to the Canadian Health Protection Branch, the European Medicines Evaluation Agency, the FDA and any other relevant national regulatory agency in any nation, and Health Authorities shall mean collectively all such regulatory authorities. | ||
1.14 | Percentage Yield means the ratio of the Yield to the Theoretical Yield with respect to a particular Bulk Lot, expressed as a percentage. | ||
1.15 | Term Year means (a) the period between the Effective Date and the end of the calendar year in which the Effective Date occurs (the First Term Year) and (b) any one of the four next following calendar years. | ||
1.16 | Theoretical Yield means the number of vials of Filled Product that could be filled from a particular Bulk Lot based on the total amount of Bulk Product in such Bulk Lot. | ||
1.17 | Yield means the number of acceptable vials of Filled Product available for shipment to BIOPORT that were filled from a particular Bulk Lot. |
2.0 | ENGAGEMENT AND LICENSE. BIOPORT hereby engages HOLLISTER-STIER, on a nonexclusive basis, and HOLLISTER-STIER hereby accepts such engagement, to provide BIOPORT with filling services to produce Filled Product in accordance with the Filling Process Specifications and the other terms and conditions set forth in this Agreement, as ordered by BIOPORT in accordance with this Agreement. BIOPORT |
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hereby grants HOLLISTER-STIER a nonexclusive, royalty-free right and license to practice any and all patents, know-how, and other intellectual properties, proprietary rights and technologies (including without limitation as to access to or use or modification of any tangible materials) owned or controlled by BIOPORT that are necessary or useful in the performance by HOLLISTER-STIER of its activities under, and in preparation for, this Agreement. | ||
3.0 | REPRESENTATIONS AND WARRANTIES. BIOPORT and HOLLISTER-STIER each represent and warrant to the other as follows: |
3.1 | It has full power and authority to enter into this Agreement and consummate the transactions contemplated hereby. | ||
3.2 | Except as provided in Section 4.10, it has or shall obtain prior to performance hereunder such permits, licenses and authorizations of government or regulatory authorities as are necessary to own its respective properties, conduct its business and consummate the transactions contemplated hereby. | ||
3.3 | It is not currently debarred, suspended, or otherwise excluded by the United States from receiving Federal contracts. | ||
3.4 | All laboratory, scientific, technical and/or other data submitted by or on behalf of BIOPORT relating to the Bulk Product or by or on behalf of HOLLISTER-STIER relating to the Filled Product, shall, to the best of the submitters knowledge, be true and correct and shall not contain any material falsification, misrepresentation or omission. | ||
3.5 | In performing its obligations or activities under or in connection with this Agreement, it shall comply with all applicable existing and future laws, rules and regulations of the United States and the States thereof; provided, however, that HOLLISTER-STIER may rely on BIOPORTs warranty that the Filling Process Specifications conform to all applicable laws, rules and regulations. | ||
3.6 | Each Party represents and warrants that neither it nor its employees or agents has made or will make any payments in connection with this Agreement or from funds paid or payable hereunder directly or indirectly to any officials or employees of any governmental agency or instrumentality. | ||
3.7 | HOLLISTER-STIER represents and warrants to BIOPORT as follows: |
3.7.1 | HOLLISTER-STIERs performance of the filling services will not violate or misappropriate any patent, copyright, trademark, trade secret or other intellectual property right of any third party (other than as may be due to HOLLISTER-STIERs compliance with BIOPORTs instructions or other matters bearing on the Bulk Product or its filling that are the responsibility of BIOPORT as provided herein). | ||
3.7.2 | The Filled Product shall when delivered to BIOPORT hereunder meet all Filling Process Specifications, be of good, merchantable and usable quality, free of defects in materials and workmanship, suitable for the purposes for which the Filled Product is to be used, and shall not be adulterated or misbranded within the meaning of the Act or other substantially similar laws and statutes; provided, however, that the foregoing shall not apply to the extent that any defect or deficiency is caused by the Bulk Product or any other materials or technologies provided by BIOPORT or is due to HOLLISTER-STIERs compliance with the Filling Process Specifications or any other instructions provided by BIOPORT. |
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3.7.3 | Subject to obtaining the rights and authorizations that are the responsibility of BIOPORT pursuant to Section 4.10, HOLLISTER-STIERs manufacturing facilities for the Filled Product: (a) conform, and will conform throughout the term of this Agreement, in all material respects with applicable laws, regulations and approvals governing such facilities, including but not limited to the cGMP as defined by 21 Code of Federal Regulations Sections 210, 211, et seq ., (b) will be adequate to produce at least [**] Filled Lots per annum; and (c) shall conform to FDA requirements for a multiple product facility, including without limitation with respect to prevention of cross contamination of products. | ||
3.7.4 | HOLLISTER-STIER shall not, during the term of this Agreement, fill any penicillin-based products, beta-lactam-based products, live viral vaccines or spore forming products in the same small volume parenteral facility used to fill any of the Filled Products (the Filling Suite). | ||
3.7.5 | All product contact parts used to fill the Filled Product will be dedicated solely to Filled Product or disposed after each use. |
3.8 | BIOPORT represents and warrants to HOLLISTER-STIER as follows: |
3.8.1 | BIOPORT has the full power and authority to grant the licenses it grants under this Agreement and to engage HOLLISTER-STIER hereunder, and the granting of the licenses granted to HOLLISTER-STIER hereunder, and the exercise by HOLLISTER-STIER of the rights granted by BIOPORT under such engagement or licenses will not breach any obligation to or right of any third party. | ||
3.8.2 | Neither the Bulk Product, the BIOPORT technology licensed hereunder, nor the use thereof by HOLLISTER-STIER, nor HOLLISTER-STIERs conduct of the filling services in conformity with the Filling Process Specifications, shall cause HOLLISTER-STIER to violate any law or infringe, violate or misappropriate any patent, copyright, trademark, trade secret or other intellectual property right of any third party. | ||
3.8.3 | The Bulk Product shipped by BIOPORT to HOLLISTER-STIER shall be accompanied by a complete and accurate AVA Bulk Formulation Lot Approval for Filling Form (the Approval for Filling Form), duly signed by an authorized representative of BIOPORTs Quality Assurance Department, and be of good, merchantable and usable quality, free of defects in materials and workmanship, suitable for the purposes for which the Bulk Product is to be used, and shall not be adulterated or misbranded within the meaning of the Act. The Bulk Product does not and will not contain any select agent as defined in subsection (j) of 42 CFR section 72.6, unless the same is exempted under subsection (h) of such section 72.6 or Appendix A of 42 CFR part 72, as such provisions may be amended from time to time. | ||
3.8.4 | BIOPORT shall not release any Filled Product for distribution, sale or use without conducting all testing and certifications thereof that are the responsibility of BIOPORT hereunder or under current health, safety and environmental regulations, laws, Health Authority rules and regulations, and industry standards. |
THE WARRANTIES SET FORTH HEREIN ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY EITHER PARTY UNDER THIS AGREEMENT, AND NEITHER PARTY MAKES ANY OTHER WARRANTIES EXPRESS OR IMPLIED OR ARISING BY LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY ARISING FROM THE COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE OF TRADE. |
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EXCEPT FOR THE INDEMNITY OBLIGATIONS SET FORTH IN THIS AGREEMENT OR FOR BREACHES OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES WILL EITHER PARTY BE LIABLE TO THE OTHER UNDER ANY CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHER LEGAL OR EQUITABLE THEORY, FOR COVER OR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST PROFITS IN CONNECTION WITH THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION THE BULK PRODUCT OR FILLED PRODUCT OR ANY SERVICES PROVIDED OR TO BE PROVIDED IN CONNECTION WITH THE BULK PRODUCT OR FILLED PRODUCT. | ||
4.0 | COVENANTS |
4.1 | The sterile Bulk Product and all vials, stoppers, seals and other materials to be provided by BIOPORT pursuant to the Filling Process Specifications will be delivered to HOLLISTER-STIER at BIOPORTs expense and liability, along with BIOPORTs Approval for Filling Form for each Bulk Lot. BIOPORT shall deliver or cause to be delivered quantities of Bulk Product and such other items, and shall do so in a timely manner, sufficient for HOLLISTER-STIER to perform the filling services called for hereunder. | ||
4.2 | To the extent called for in the Filling Process Specifications, HOLLISTER-STIER shall conduct materials tests of each Bulk Lot, but no such testing (or failure so to test) will relieve BIOPORT of its responsibility hereunder to deliver the Bulk Product in conformity with the requirements of the Approval for Filling Form, as based on the Bulk Product Specifications. If such materials tests indicate that any of the Bulk Product does not meet the requirements of the Approval for Filling Form, as based on the Bulk Product Specifications, HOLLISTER-STIER will immediately so inform BIOPORT and BIOPORT will supply replacement Bulk Product that does conform to the Bulk Product Specifications. | ||
4.3 | For each Filled Lot filled by HOLLISTER-STIER, HOLLISTER-STIER shall perform the following testing for compliance with the Filling Process Specifications: final container sterility and gross visual inspection. Upon completion of such testing and review of manufacturing records, HOLLISTER-STIER shall submit to BIOPORT a COA listing the results of such testing and copies of all agreed upon records. Subject to HOLLISTER-STIERs prior consent (such consent not to be unreasonably withheld if either the same does not add to the costs of HOLLISTER-STIERs performance hereunder or BIOPORT agrees to bear all additional costs associated with the same), BIOPORT, may, from time to time, change the type of test(s) or the form of the records to be provided by HOLLISTER-STIER to BIOPORT for each Filled Lot. | ||
4.4 | BIOPORT is responsible for the release of the Filled Product for sale or distribution. | ||
4.5 | BIOPORT is responsible for the Stability Testing Program for the Filled Product. | ||
4.6 | BIOPORT is responsible for maintaining Retention Samples of Filled Product. | ||
4.7 | BIOPORT is responsible for compliance with the requirements of all Health Authorities concerning the reporting of any adverse reactions or other events (Adverse Events) that may occur as the result of the manufacture, testing, sale or use of the Bulk Product or the Filled Product. HOLLISTER-STIER shall advise BIOPORT promptly of any Adverse Event, safety or toxicity problem reported to HOLLISTER-STIER regarding Filled Product. | ||
4.8 | Except as required by applicable law and/or regulations, or in order to seek approval of any Health Authority, neither Party shall make any use of the other Partys name, |
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whether in a press release, company profile, promotional or advertising material or otherwise, without the other Partys prior written approval. | |||
4.9 | BIOPORT and HOLLISTER-STIER shall provide to each other copies of all correspondence from Health Authorities related to the Bulk Product or Filled Product, including all inspection reports issued by Health Authorities during the term of this Agreement, provided, however, that BIOPORT shall only be required to provide such copies to the extent they relate to the filling process or the filling services of HOLLISTER-STIER. HOLLISTER-STIER shall provide informal notice within 24 hours by telephone of any such inquiry or inspection. All documents provided by HOLLISTER-STIER to any Health Authority, with respect to Filled Product or Bulk Product or its SVP facility, shall be provided to BIOPORT in advance for review and comment if feasible, and in no case shall such documents be provided to BIOPORT later than three (3) business days after such documents are provided to any Health Authority. To the extent permitted by law or regulation: (a) HOLLISTER-STIER shall promptly notify BIOPORT of all Health Authority inspections concerning the Filled Product or Bulk Product, and (b) BIOPORT shall have the right to be present for such inspection, at BIOPORTs risk and expense. | ||
4.10 | While HOLLISTER-STIER shall be responsible to obtain and maintain any generally-applicable FDA approvals of its facility as a licensed FDA facility (i.e., not specific to the manufacture of Filled Product or to the receipt, storage, shipping or handling of Bulk Product or Filled Product), BIOPORT shall be solely responsible at its risk and expense for obtaining all permits, licenses, and authorizations necessary for HOLLISTER-STIER to fill and ship the Filled Product under this Agreement. Filling operations are to be performed using appropriate safety measures and containment techniques as dictated by current health, safety and environmental regulations, laws, Health Authority rules and regulations, and industry standards. | ||
4.11 | BIOPORT shall supply HOLLISTER-STIER with a Safety Sheet and the U.S. Department of Transportation Hazard Classification for the Bulk Product and Filled Product. HOLLISTER-STIER and BIOPORT shall cooperate reasonably to develop mutually-agreed safety procedures as amendments to the Filling Process Specifications, for the handling of the Bulk Product and Filled Product and treatment or disposal of wastes relating thereto that comply with all federal, and state environmental and occupational safety and health requirements. HOLLISTER-STIER shall, in accordance with BIOPORTs instructions, ship rejected Bulk Product or Filled Product to such destination as BIOPORT shall designate in writing. The expense for disposal or reclamation of rejected Bulk Product or Filled Product and waste shall be borne by BIOPORT, provided, however, that the expense for disposal of rejected Bulk Product or Filled Product due to failure of HOLLISTER-STIER to perform its obligations under this Agreement shall be borne by HOLLISTER-STIER. HOLLISTER-STIER will not dispose of rejects or waste Bulk Product or Filled Product without prior written consent from BIOPORT. | ||
4.12 | No changes to the Filling Process Specifications shall be made without the mutual written consent of BIOPORT and HOLLISTER-STIER. However, the Parties agree to amend the Filling Process Specifications at the times, and in accordance with the procedures, set forth in the Filling Process Specifications, in order, among other things, to alter the preliminary Percentage Yield called for under the Filling Process Specifications to reasonably reflect the Yields obtained by HOLLISTER-STIER in the initial Filled Lots during the term hereof. | ||
4.13 | HOLLISTER-STIER shall not make any changes or additions to or alter in any way its Filling Suite, or the equipment, testing procedures, validation, suppliers of raw materials and components, or documentation systems that relate to the Bulk Product or the Filled Product without the prior written consent of BIOPORT, which consent shall not be unreasonably withheld or delayed. |
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4.14 | HOLLISTER-STIER shall provide BIOPORT with not less than thirty (30) days advance written notice of HOLLISTER-STIERs commencement of production or filling in the Filling Suite of any product that is not within one or more of the Product Classifications specified in the Filling Process Specifications. Product Classifications means those types and classes of products any of which are or have been produced or filled in the Filling Suite, including those as of or prior to the Effective Date and those of which HOLLISTER-STIER gives notice under this Section (all of which shall be deemed from that point forward to be added to the list of Prior Product Classifications in the Filling Process Specifications). | ||
4.15 | The Parties agree that the filling services under this Agreement shall be conducted at the HOLLISTER-STIER facility in Spokane, Washington. | ||
4.16 | Subject to the confidentiality provisions of Section 8, BIOPORT shall have the right, at its risk and expense, to have personnel on site (maximum of two people) observing operations during filling and other related activities. |
5.0 | ORDERING AND SUPPLY OF FILLED PRODUCT |
5.1 | HOLLISTER-STIER agrees to meet all of BIOPORTs firm purchase orders for Filled Product, based on BIOPORTs forecasts for Filled Product as set forth in Section 5.2 of this Agreement. | ||
5.2 | BIOPORT and HOLLISTER-STIER shall cooperate in estimating and scheduling production of commercial orders. |
5.2.1 | BIOPORT shall annually provide a Good Faith Annual Estimate of the timing and pace of its expected specific orders for Filled Product. The first such Good Faith Annual Estimate shall be given upon execution of this Agreement and shall cover orders during the remainder of the First Term Year, and subsequent Good Faith Annual Estimates shall be delivered to HOLLISTER-STIER on or before each November 1, with respect to the next following Term Year. The estimates in each Good Faith Annual Estimate shall be good faith forecasts to assist HOLLISTER-STIER in planning its production and shall be non-binding and without prejudice to BIOPORTs subsequent firm orders. | ||
5.2.2 | Subject to Section 5.2.4, on or before the first day of each calendar month, BIOPORT shall provide a firm purchase order for the next following calendar month, thereby constituting a rolling monthly firm purchase order; provided, however, that during any Term Year in which BIOPORT is filling AVA itself (or is actively preparing to do so), or is obtaining or has contracted to obtain AVA filling services from any other source, BIOPORT shall, on or before the first day of each calendar month, provide a firm purchase order for the next three following calendar months, thereby constituting a rolling three-month firm purchase order. | ||
5.2.3 | To the extent that BIOPORT requests that HOLLISTER-STIER fill more lots than are the subject of a firm purchase order, HOLLISTER-STIER shall accommodate such additional fill requests subject to its then-available production capacity. | ||
5.2.4 | BIOPORT may, without charge or breach of this Agreement, cancel or delay any firm order for a Filled Lot or Filled Lots, provided that it gives HOLLISTER-STIER notice of such cancellation or delay prior to the acceptance of the Bulk Lot for such Filled Lot(s) by HOLLISTER-STIER in accordance with the incoming inspection requirements as set forth in the Filling Process Specifications. Where BIOPORT gives such notice of a delay, rescheduling of the delayed Filled Lot |
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5.3 | If BIOPORT believes that a Filled Lot as delivered to it by HOLLISTER-STIER does not conform to the Filling Process Specifications, BIOPORT shall promptly so notify HOLLISTER-STIER, specifying the grounds for BIOPORTs belief in as much detail as is available to BIOPORT. If HOLLISTER-STIER disagrees, the Parties shall use their best efforts to resolve such disputes amicably. If the parties are unable to resolve the dispute, the matter shall be referred for resolution to an independent laboratory or other recognized expert, agreed to by the parties, whose decision shall be final and binding. Any charges of such laboratory or expert shall be paid for by the party against whom the dispute is decided. If BIOPORT does not give HOLLISTER-STIER such a notice of non-conformity prior to the tenth (10 th ) business day following delivery of the COA for a given Filled Lot and the batch record for such Filled Lot, BIOPORT will be deemed to have accepted such Filled Lot. | ||
5.4 | Where volumes of Bulk Product in excess of those anticipated under the Percentage Yields called for in the Filling Process Specifications do not meet the Filling Process Specifications or are made unusable or are otherwise destroyed in the course of the filling services for a Filled Lot, but the balance of such Filled Lot remains in conformity with this Agreement, BIOPORT shall AS ITS SOLE REMEDY THEREFOR, be entitled to a prorata price adjustment to reflect the shortfall (to the extent under such Percentage Yield) in the anticipated volume in such Filled Lot. As an example, if the Percentage Yield called for in the Filling Process Specifications for a Filled Lot is [**]% and the actual Percentage Yield achieved for such Filled Lot is [**]%, then the price for such Filled Lot (as otherwise determined under Article 6) would be reduced by [**]% (representing [**]% [**]%). | ||
5.5 | If an entire Filled Lot is made unusable or is destroyed, either through the fault of HOLLISTER-STIER or otherwise because it does not meet the Filling Process Specifications, HOLLISTER-STIER shall promptly so inform BIOPORT or BIOPORT shall promptly so inform HOLLISTER-STIER, as the case may be, together with an explanation of the circumstances and HOLLISTER-STIER shall, AS BIOPORTS SOLE REMEDY THEREFOR, (i) conduct the filling services for the replacement Bulk Lot without charge, including bearing the cost of vials, stoppers, seals and other costs associated with the filling and preparation for shipment of the Filled Product, provided that BIOPORT at its risk and expense (other than shipping costs) supplies the replacement Bulk Lot; (ii) conduct a non-conforming materials run without charge to BIOPORT, if reasonably so requested by BIOPORT; (iii) conduct, without charge to BIOPORT, appropriate additional training of personnel, development work and/or technical studies to address the causes underlying the failed fill as BIOPORT and HOLLISTER-STIER agree in good faith after consultation are called for under the circumstances; and (iv) pay for all destruction costs associated with the rejected material, including any shipment related expenses, any such destruction only to occur with BIOPORTs prior written consent. |
6.0 | PRICE PAYMENT |
6.1 | The initial price to be paid by BIOPORT for the filling services for each Filled Lot (the Lot Production Fee) shall be [**] dollars ($[**]); provided, however, that effective for Filled |
8
Products shipped following the thirtieth day after the first and each subsequent anniversary of the Effective Date, the initial Lot Production Fee set forth above shall be increased to reflect increases (if any, but not decreases) since the Effective Date in the Producer Price Index Pharmaceutical Preparations (code PCU2834) published by the US Bureau of Labor Statistics, or if the same is no longer published, the successor index published by the US BLS that is most similar thereto (the Index). | |||
6.2 | All prices for Filled Product shall be on the basis of Filled Product being shipped F.O.B. HOLLISTER-STIERs plant in Spokane, Washington. Shipment of Filled Product shall be arranged by BIOPORT and the cost and liability of such shipment shall be borne by BIOPORT. | ||
6.3 | In addition to the prices for Filled Product specified under Section 6.1, and the matters described in Sections 4.3 and 4.10, certain additional costs specifically associated with HOLLISTER-STIERs performance and preparation for performance under this Agreement have been borne by BIOPORT and/or the U.S. Government under separate agreements, either as one-time costs or otherwise. Any future such additional costs shall be negotiated by the parties in good faith, and where appropriate BIOPORT shall assist HOLLISTER-STIER to obtain reimbursement therefor from the U.S. Government, either directly or through BIOPORT. | ||
6.4 | HOLLISTER-STIER will issue an invoice at such time as BIOPORT has accepted the Filled Lot pursuant to Section 5.3. | ||
6.5 | BIOPORT will be required to pay HOLLISTER-STIER for all Filled Product ordered during any period when Production and Testing Procedures have not been fully developed and validated, either initially or due to any agreed changes or modifications thereto. | ||
6.6 | During periods when the cost for filling services is to be directly reimbursed by the Government to BIOPORT: (a) BIOPORT will include HOLLISTER-STIERs invoice amounts, with respect to Filled Product to be provided to the U.S. Government, in its invoice to the Government submitted on or before the 30 th day of the month and shall pay HOLLISTER-STIER within ten (10) days of receiving payment from the Government; and (b) regardless of whether BIOPORT shall receive compensation from the Government, BIOPORT shall pay HOLLISTER-STIER a minimum of [**]% of the invoiced amount within thirty (30) days of receipt of HOLLISTER-STIERs invoice and shall within 90 days of HOLLISTER-STIERs issuance of the invoice pay HOLLISTER-STIER the balance of the invoiced amounts if BIOPORT has not received payment from the Government due to any fault or deficiency in BIOPORTs performance, billing or documentation under its contract with the Government. During periods when the cost for filling services is to be included in the price of Filled Product to be provided by BIOPORT to the Government, and at all times with respect to Filled Product to be supplied to any BIOPORT customer other than the U.S. Government, BIOPORT shall pay HOLLISTER-STIERs invoices within thirty days of receipt of invoice. | ||
6.7 | The remittance address for payments to HOLLISTER-STIER hereunder is: |
7.0 | AUDITS AND INSPECTIONS. HOLLISTER-STIER shall allow up to [**] of BIOPORTs personnel (or its authorized representatives as approved for such purpose by HOLLISTER-STIER, which approval shall not be unreasonably withheld) access, during normal business hours up to two (2) times per Term Year (and not more than three days per time), to HOLLISTER-STIERs facilities for the purpose of conducting a quality |
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systems audit as such systems relate to the filling and packaging of the Filled Products. HOLLISTER-STIERs personnel shall provide such BIOPORT personnel or such approved authorized representatives with all necessary assistance, including access to documents and reports to the extent bearing on the filling services (including but not limited to validation documents), during such inspections. The failure to inspect shall not be deemed a waiver of any of BIOPORTs rights or of HOLLISTER-STIERs obligations under this Agreement. | ||
8.0 | CONFIDENTIALITY. The parties acknowledge and agree that the terms and conditions of this Agreement shall remain confidential. The Parties acknowledge and agree that all Confidential Information of a Party shall be considered confidential and proprietary to such Party. Each Party agrees not to use any Confidential Information of the other Party for any purpose other than as permitted herein or required for the performance by such Party of its obligations hereunder. Each Party also agrees, during and following the term of this Agreement, not to disclose or provide any of the other Partys Confidential Information except to its personnel, contractors or consultants with a need to know the same for purposes of such Partys performance under this Agreement and to take reasonable precautions (at least as protective as those such Party takes to protect its own, and in no event less than reasonable precautions, to prevent the disclosure of the other Partys Confidential Information to any other third party or for any other purpose. Nothing herein shall prevent either Party from disclosing any Confidential Information of the other Party to the extent such disclosure is required by applicable law or regulation, or by order of any court or governmental body, provided that such Party gives the other Party such advance notice of the disclosure as may be practicable under the circumstances and assists with any reasonable attempts by such other Party to limit or to restrict such disclosure in accordance with applicable law. | |
9.0 | AUTHORIZED CONTACTS. The Parties will interact for purposes of this Agreement primarily through their designated primary contacts. HOLLISTER-STIERs primary contact for this Agreement is [**], and BIOPORTs primary contact for this Agreement is [**]. Either Party may change its primary contact from time to time by written notice from either the out-going primary contact or from such Partys President. | |
10.0 | TERM AND TERMINATION. This Agreement will become effective as of the Effective Date and shall continue in effect until the end of the fifth Term Year (December 31, 2006), provided, however, that either party may terminate this Agreement in the event of a material breach by the other party of any one or more terms or obligations of this Agreement which is not remedied within ninety (90) days after receipt of written notice of the breach from the non-breaching party or, if such breach cannot reasonably be cured within such 90-day period, if the breaching party has failed to commence such cure within the 90-day period or to proceed diligently to prosecute such cure to completion within a reasonable time thereafter. | |
11.0 | RELATIONSHIP OF PARTIES. With respect to the subject matter under this Agreement, the Parties are and remain independent contractors. This Agreement shall not be deemed to create a joint venture, partnership, association, or agency between the Parties. Neither Party hereunder is authorized to incur or create any obligation, express or implied, on behalf of the other Party or to bind the other Party in any manner whatsoever. | |
12.0 | DISPUTES. All disputes arising under this Agreement that can not be settled amicably, shall be finally resolved by arbitration in Chicago, Illinois, before a single arbitrator pursuant to the Commercial Arbitration Rules of the American Arbitration Association then in effect, and any arbitral award thereon may be enforced by any court of competent jurisdiction. The prevailing Party in any arbitration shall be entitled to reimbursement from the other Party for the prevailing Partys attorneys fees and other costs and |
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expenses incurred in, and in preparation for, the arbitration and the enforcement of any judgment therefrom. | ||
13.0 | INSURANCE. BIOPORT and HOLLISTER-STIER each agree to maintain in force during the term of this Agreement product liability and other insurance coverage commensurate with industry standards and practices. | |
14.0 | NO LIENS. HOLLISTER-STIER will not allow, directly or indirectly, create, incur, assume or permit to exist any lien or encumbrance of any kind on the Bulk Product or Filled Product. | |
15.0 | NO SOLICITATION OF EMPLOYEES OR CUSTOMERS. Both Parties agree that, during the term of this Agreement, and for a period of twelve (12) consecutive months after termination of such Agreement, neither of the Parties will (a) directly induce or attempt to induce or otherwise counsel, advise, solicit or encourage any employee to leave the employ of the other Party or to accept employment with any other person or entity, (b) employ any person who, as of the time of such employment, had left the employ of the other Party within the previous six (6) months, and (c) actively solicit any customer, client, or business partner of the other Party to cease or reduce its relationship with that Party or induce or attempt to induce any such customer, client, or business partner to breach any agreement that such customer, client, or business partner may have with the other Party. | |
16.0 | INDEMNIFICATION. |
16.1 | Indemnification of BIOPORT. HOLLISTER-STIER shall indemnify, defend and hold BIOPORT and its directors, personnel, owners, and agents harmless from and against any and all damages, losses, obligations, deficiencies, liabilities, costs, expenses, penalties, claims and encumbrances, including without limitation, attorneys fees and disbursements, resulting from or arising out of any third party claim or demand, including but not limited to a claim or demand for bodily injury or death, alleged to have arisen due to or in connection with any breach of warranty by HOLLISTER-STIER hereunder or otherwise due to or in connection with a manufacturing defect in any Filled Product manufactured by HOLLISTER-STIER otherwise than in accordance with the Filling Process Specifications. | ||
16.2 | Indemnification of HOLLISTER-STIER. BIOPORT agrees to indemnify, defend, and hold harmless HOLLISTER-STIER and its directors, personnel, owners, and agents from and against any and all damages, losses, obligations, deficiencies, liabilities, costs, expenses, penalties, claims and encumbrances, including, without limitation, attorneys fees and disbursements, resulting from and arising out of any third party claim or demand, including but not limited to a claim or demand for bodily injury or death, alleged to have arisen due to or in connection with any breach of warranty by BIOPORT hereunder or otherwise due to or in connection with the production, use, sale, distribution, advertising and/or marketing of the Bulk Product or the Filled Product, except to the extent such claim or demand is the result of HOLLISTER-STIERs failure to manufacture Filled Product in accordance with the Filling Process Specifications. | ||
16.3 | Procedures. Subject to the requirements and procedures specified in FAR 52.250-1, where applicable, BIOPORT and HOLLISTER-STIER agree to give, and agree that their respective directors, personnel, owners, and agents shall give, to the Party that is obligated to indemnify pursuant to this Section 16: (a) prompt notice of any claim or suit coming within the scope of the indemnities in this Section, (b) all relevant facts in its possession or control, (c) the right to exclusively control the defense or settlement of any action unless the Party or person being indemnified reasonably determines that a conflict of interest exists with respect to such assumption of such control due to actual or |
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potential differing interests between the parties, and (d) its reasonable cooperation in the defense or settlement of any such action . | |||
16.4 | Limitation of Indemnification Liability. Neither party shall have any liability under this Section to the other or its directors, personnel, owners, and agents to the extent that damages, losses, obligations, deficiencies, liabilities, costs, expenses, penalties, claims and encumbrances result from the willful misconduct or gross negligence of the Party seeking indemnification (or whose directors, personnel, owners, and agents are seeking indemnification), or that of its officers directors, agents or employees. |
17.0 | LIMITATION OF LIABILITY. | |
Neither party shall be responsible to the other for payment of consequential, special or incidental damages. With the exception of a third party claim or demand for bodily injury or death alleged to have arisen due to or in connection with the manufacture of Filled Product by HOLLISTER-STIER otherwise than in accordance with the Filling Process Specifications, in no event shall HOLLISTER-STIERs liability under Section 16 hereof exceed the Lot Production Fee and the other costs as described in Section 5.4 hereof to be borne by HOLLISTER-STIER. | ||
18.0 | FORCE MAJEURE. | |
If either Partys performance of its respective obligations hereunder is prevented or made unprofitable to it by fire, strike, lockouts, war, civil disturbances, acts of God, altered laws or regulations, or other similar or dissimilar events beyond the reasonable control of the Party, the Party will not be liable to the other Party for damages or for breach of this Agreement. The Party being able to perform may, at its sole option, either (a) terminate this Agreement if the other Party is or reasonably appears likely to be so prevented from performing for a period in excess of 120 days, (b) extend the term of this Agreement by a period equal in length to the period during which the other Party was unable to perform its obligations hereunder, or (c) waive such obligations. | ||
19.0 | SEVERABILITY . | |
In the event that any one or more of the agreements, covenants, provisions or terms contained herein shall be declared invalid, illegal or unenforceable in any respect, the validity of the remaining agreements, covenants, provisions or terms contained herein shall in no way be affected, prejudiced or invalidated thereby. | ||
20.0 | PRIME CONTRACT FLOW DOWN | |
The following Federal Acquisition Regulations (FAR) clauses are incorporated herein by reference: | ||
The services being provided by HOLLISTER-STIER under this Filling and Packaging Agreement represent subcontracted work under U.S. Army Medical Research and Material Command contract DAMD17-98-C-8052. The following provisions in that contract are hereby incorporated by reference into this subcontract and made a part thereof except that where not inappropriate in the context of the clauses (e.g., it is agreed to be inappropriate to alter the meaning of Government or of Contracting Officer in clause 52.249-2, Termination for Convenience of the Government in this way, and clause 52.249-2 will only be applied to this Agreement if and to the extent that the Government exercises that clause to terminate BIOPORTs agreements with the Government), Government shall mean BIOPORT, Contracting Officer shall mean BIOPORTs representative, Contractor shall mean HOLLISTER-STIER, and other terms shall be appropriately revised to reflect that this is a subcontract: |
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52.202-3 | Gratuities (Apr 1984) | ||
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52.203-1 | Officials Not To Benefit (Apr 1984) | ||
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52.203-5 | Covenant Against Contingent Fees (Apr 1984) | ||
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52.203-6 | Restrictions on Subcontractor Sales to the Government (Jul 1995) | ||
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52.203-7 | Anti-Kickback Procedures (Jul 1995) | ||
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52.203-8 | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Jan 1997) | ||
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52.203-12 | Limitation on Payments to Influence Certain Federal Transactions (Jun 1997) | ||
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52.211-15 | Defense Priority and Allocation Requirements (Sep 1990) | ||
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52.215-2 | Audit and Records Negotiation (Aug 1996) | ||
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52.215-13 | Subcontractor Cost or Pricing Data-Modifications (Oct 1997) | ||
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52.215-15 | Termination of Defined Benefit Pension Plans (Oct 1997) | ||
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52.215-18 | Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other Than Pensions (Oct 1997) | ||
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52.215-19 | Notification of Ownership Changes (Oct 1997) | ||
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52.219-8 | Utilization of Small Business Concerns and Small Disadvantaged Business Concerns (Feb 1990) | ||
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52.222-3 | Convict Labor (Aug 1996) | ||
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52.222-4 | Contract Work Hours and Safety Standards Act Overtime Compensation (Mar 1986) | ||
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52.222-20 | Walsh-Healey Public Contracts Act (Dec 1996) | ||
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52.222-26 | Equal Opportunity (Apr 1984) | ||
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52.222-35 | Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era (Apr 1998) | ||
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52.222-36 | Affirmative Action for Workers with Disabilities (Jun 1998) | ||
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52.222-37 | Employment Reports on Disabled Veterans and Veterans of the Vietnam Era (Apr 1998) | ||
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52.223-2 | Clean Air and Water (Apr 1984) | ||
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52.223-6 | Drug-Free Workplace (Jan 1997) | ||
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52.223-14 | Toxic Chemical Release Reporting (Oct 1996) | ||
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52.225-10 | Duty-Free Entry (Apr 1984) | ||
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52.225-11 | Restrictions on Certain Foreign Purchases (Aug 1998) | ||
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52.226-2 | Notice and Assistance Regarding Patent and Copyright Infringement (Aug 1996) |
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52.227-1 | Authorization and Consent (Jul 1995) | ||
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52.242-12 | Report of Shipment (REPSHIP) (Jul 1995) | ||
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52.243-1 | Changes Fixed-Price (Aug 1987) | ||
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52.249-2 | Termination for Convenience of the Government (Fixed-Price) (Sep 1996) | ||
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52.249-8 | Default (Fixed-Price Supply and Service) (Apr 1984) | ||
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52.249-14 | Excusable Delays (Apr 1984) | ||
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52.250-1 | Indemnification under Public Law 85-804 (4/84) |
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252.203-7000 | Statutory Prohibition on Compensation to Former Department of Defense Employees (Dec 1991) | ||
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252.203-7001 | Special Prohibition on Employment (Jun 1997) | ||
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252.203-7002 | Display of DOD Hotline Poster (Dec 1991) | ||
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252.204-7000 | Disclosure of Information (Dec 1991) | ||
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252.223-7004 | Drug-Free Work Force (Sep 1988) | ||
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252.231-7000 | Supplemental Cost Principles (Dec 1991) | ||
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252.243-7001 | Pricing of Contract Modifications (Dec 1991) |
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Copies of these clauses are available in applicable Government publications. Some clauses are no longer set forth in the current DFAR and must be obtained from prior versions of the DFAR | ||
23.0 | NOTICES. | |
Subject to Section 6.7, all notices permitted or required by this Agreement or other communications to either Party by the other shall be in writing and shall be deemed given (a) upon personal delivery or (b) three (3) days after being deposited in the United States mail (first class, postage prepaid) or (c) the day after being given to a reputable carrier for overnight shipment, addressed as follows: |
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To HOLLISTER-STIER: | Hollister-Stier Laboratories LLC | ||
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P.O. Box 3145 | |||
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Spokane, Washington, 99220-3145 | |||
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Attn: Anthony Bonanzino, President | |||
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To BIOPORT: | BioPort Corporation | ||
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3500 North Martin Luther King Blvd. | |||
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Lansing, MI 48906 | |||
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Attn: Robert G. Kramer, President |
24.0 | ENTIRE AGREEMENT. | |
This Agreement contains the entire agreement between the Parties with respect to the subject matter hereof and supersedes any prior agreements between them with respect to that subject matter, including without limitation the Filling and Packaging Services Agreement dated December 21, 2000. |
BIOPORT CORPORATION | HOLLISTER-STIER | |||||||||
LABORATORIES LLC | ||||||||||
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By
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/s/ Robert G. Kramer | By | /s/ Anthony Bonanzino | |||||||
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Its:
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President | Its: | President |
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A. | Amendment | |
Pursuant to Section 6.0 Price Payment Paragraph 6.1 the price to be paid by BioPort for the filling services for each Filled Lot (the Lot Production Fee) shall be [**] dollars ($[**]) as of the effective date of this Amendment. | ||
B. | Remaining Agreement | |
Except as set forth in Section A. hereof, all other terms, provisions and conditions of the Agreement remain in full force and effect as of the date hereof. | ||
In WITNESS WHEREOF, the parties have executed this Amendment No. 1 as of the date hereinabove stated, to be effective as of the date hereinabove stated. |
HOLLISTER-STIER LABORATORIES LLC | BIOPORT CORPORATION | |||||||||
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By:
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/s/ Anthony D. Bonanzino | By: | /s/ Robert G. Kramer | |||||||
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Name: Anthony D. Bonanzino, Ph. D. | Name: Robert G. Kramer | |||||||||
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Title: President and CEO | Title: President & COO | |||||||||
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Date: March 13, 2003 | Date: June 4, 2003 |
A. | Amendment | |
Pursuant to Section 6.0 Price Payment Paragraph 6.1 the price to be paid by BioPort for the filling services for each Filled Lot (the Lot Production Fee) shall be [**] dollars ($[**]) as of the effective date of this Amendment. This pricing adjustment is based off the successor PPI index series PCU3254 for Pharmaceutical Preparations Mfg. The new price is calculated by the net change in the index between the Preliminary index for March of 2004 (355.1) and the base year index of March 2002 (323.7). The net effective increase in successive years will be calculated in this same manner, using the preliminary March index net increase over the base year index of March 2002. | ||
B. | Remaining Agreement | |
Except as set forth in Section A. hereof, all other terms, provisions and conditions of the Agreement remain in full force and effect as of the date hereof. | ||
In WITNESS WHEREOF, the parties have executed this Amendment No. 2 as of the date hereinabove stated, to be effective as of the date hereinabove stated. |
HOLLISTER-STIER LABORATORIES LLC | BIOPORT CORPORATION | |||||||||
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By:
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/s/ Anthony D. Bonanzino | By: | /s/ Robert G. Kramer | |||||||
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Name: Anthony D. Bonanzino, Ph. D. | Name: Robert G. Kramer | |||||||||
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Title: President and CEO | Title: President | |||||||||
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Date: 05/17/2004 | Date: 5/24/04 |
BIOPORT CORPORATION | HOLLISTER-STIER | |||||||||
LABORATORIES, LLC | ||||||||||
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By:
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/s/ Robert G. Kramer 9/3/04 | By: | /s/ [Illegible] 9-4-04 | |||||||
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Title: President | Title: V.P. ENG/VAL./PD. |
1. | Pursuant to the provisions of Section 21.0 of the Agreement, the effective date of the Agreement shall be December 27, 2002. | ||
2. | FAR Clause 52.250-1 and the Modification P00036 to Contract 8052, each of which are attached to this Amendment, are hereby incorporated by reference into the Agreement. | ||
3. | Section 16.2 of the Agreement (entitled Indemnification of HOLLISTER-STIER) is amended by inserting the following clause in front of the first sentence : Except to the extent Hollister-Stier is indemnified from and against liabilities by the United States Government as a result of pass-through indemnification pursuant to FAR Clause 52.250-l,. | ||
4. | All other provisions of the Agreement, including all Exhibits or Addendums thereto, remain in full force and effect, and this Amendment is subject to the terms thereof. |
BIOPORT CORPORATION | HOLLISTER-STIER | |||||||||
LABORATORIES, LLC | ||||||||||
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By:
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/s/ Robert G. Kramer | By: | /s/ [Illegible] | |||||||
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Title: President | Title: Vice President |
1. CONTRACT ID CODE AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT J PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO. December 27, 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (if applicable) P00036 2002 N/A N/A |
6. ISSUED BY CODE DASG60 7. ADMINISTERED BY (If other than Item 8) CODE S2303A U.S. Army Space and Missile Defense Command Attn: SMDC -CM-CH (L. Selfridge) DCMC Detroit-Grand Rapids 64 Thomas Johnson Drive, 3 rd Floor 678 Front Avenue, NW Frederick, MD 21702 Grand Rapids, Michigan 49504-5352 |
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and Zip Code) ( ) 9A. AMENDMENT OF SOLICITATION NO. BIOPORT CORPORATION 3500 N. MARTIN LUTHER KING, JR. BLVD. LANSING, MI 48906 9B. DATED (See Item 11) |
10A. MODIFICATION OF CONTRACT/ORDER NO. X DAMD17-98-C-8052 |
10B. DATED (See Item 13) CODE 025489018 FACILITY CODE September 17, 1998 |
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers [ ] is extended [ ] is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and |
returning ___copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) by separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF : |
D. OTHER (Specify type of modification and authority) X Public Law 85-804 and Memorandum of Decision dated November 15, 2000 signed by the SECARMY |
E. IMPORTANT : Contractor [ X ] is not, [ ] is required to sign this document and return ___copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) See Attached. Except as provided herein, all terms and conditions of the document referenced in Items 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Lynn M. Selfridge Contracting Officer 16B. UNITED STATES OF AMERICA BY /s/ Lynn M. Selfridge. (Signature of person authorized to sign) 15C. DATE SIGNED (Signature of Contracting Officer) Dec 27, 2002 |
NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83) PREVIOUS EDITION UNUSABLE Prescribed by GSA |
Hollister-Stier Laboratories LLC | BioPort Corporation | ||||||||||
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By:
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/s/ A. Bonanzino | By: | /s/ Robert G. Kramer | ||||||||
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Name:
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/s/ A. Bonanzino | Name: | Robert G. Kramer | ||||||||
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05/19/2006 | Date: | May 23, 2006 |
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if to HPA, to: | Health Protection Agency | ||
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Porton Down
Salisbury, Wiltshire SP4 0JG England |
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Attention: Dr. David Rhodes | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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with a copy to: | Legal Department | ||
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Health Protection Agency | |||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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if to Emergent, to: | Emergent BioSolutions, Inc. | ||
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300 Professional Drive | |||
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Gaithersburg, Maryland 20879 USA | |||
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Attention: General Counsel | |||
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Facsimile No.: +1-301-590-1252 |
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with a copy to: | Covington & Burling | ||
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One Front Street, 35th Floor | |||
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San Francisco, California 94111 USA | |||
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Attention: James C. Snipes, Esq. | |||
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Facsimile No.: +1-415-591-6091 |
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Emergent BioSolutions, Inc. | Health Protection Agency | |||||||||
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By:
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/s/ Fuad El-Hibri
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By: |
/s/ Pat Troop
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Title:
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Chairman and CEO | Title: | CEO |
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Molecular technologies: | ||||
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Protein technologies: | ||||
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Patent No.
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Patent Type | |
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Patent No.
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Patent | Title | HPA License Agreements | Agreement Date | ||||
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if to HPA, to: | Health Protection Agency | ||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Attention: Dr. David Rhodes | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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with a copy to: | Legal Department | ||
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Health Protection Agency | |||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Facsimile No.: +44-1980-61-22-41 |
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if to Emergent, to: | Emergent BioSolutions, Inc. | ||
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300 Professional Drive | |||
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Gaithersburg, Maryland 20879 USA | |||
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Attention: General Counsel | |||
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Facsimile No.: +1-301-590-1252 | |||
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with a copy to: | Covington & Burling | ||
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One Front Street, 35th Floor | |||
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San Francisco, California 94111 USA | |||
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Attention: James C. Snipes, Esq. | |||
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Facsimile No.: +1-415-591-6091 |
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Emergent BioSolutions, Inc. | Health Protection Agency | |||||||||
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By:
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/s/ Fuad El-Hibri | By: | /s/ Pat Troop | |||||||
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Fuad El-Hibri | Pat Troop | ||||||||
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Title:
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Chairman and CEO | Title: | CEO |
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if to HPA, to: | Health Protection Agency | ||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Attention: Dr. David Rhodes | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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with a copy to: | Legal Department | ||
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Health Protection Agency | |||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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if to Emergent, to: | Emergent BioSolutions, Inc. | ||
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300 Professional Drive | |||
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Gaithersburg, Maryland 20879 USA | |||
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Attention: General Counsel | |||
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Facsimile No.: +1-301-590-1252 | |||
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with a copy to: | Covington & Burling | ||
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One Front Street, 35th Floor | |||
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San Francisco, California 94111 USA | |||
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Attention: James C. Snipes, Esq. | |||
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Facsimile No.: +1-415-591-6091 |
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Emergent
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BioSolutions, Inc. | Health | Protection Agency | |||||||
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By:
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/s/ Fuad El-Hibri | By: | /s/ Pat Troop | |||||||
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Fuad El-Hibri | Pat Troop | ||||||||
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Title:
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Chairman and CEO | Title: | CEO |
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· | Clostridium botulinum, strains |
o | [**] |
o | [**] |
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if to HPA, to: | Health Protection Agency | ||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Attention: Dr. David Rhodes | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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with a copy to: | Legal Department | ||
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Health Protection Agency | |||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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if to Emergent, to: | Emergent BioSolutions, Inc. | ||
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300 Professional Drive | |||
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Gaithersburg, Maryland 20879 USA | |||
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Attention: General Counsel | |||
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Facsimile No.: +1-301-590-1252 | |||
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with a copy to: | Covington & Burling | ||
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One Front Street, 35th Floor | |||
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San Francisco, California 94111 USA | |||
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Attention: James C. Snipes, Esq. | |||
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Facsimile No.: +1-415-591-6091 |
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Emergent BioSolutions, Inc. | Health Protection Agency | |||||||
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By:
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/s/ Fuad El-Hibri | By: | /s/ Pat Troop | |||||
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Fuad El-Hibri | Pat Troop | ||||||
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Title:
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Chairman and CEO | Title: | CEO |
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if to Supplier, to: | Health Protection Agency | ||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Attention: Dr. David Rhodes | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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with a copy to: | Legal Department | ||
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Health Protection Agency | |||
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Porton Down | |||
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Salisbury, Wiltshire SP4 0JG England | |||
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Facsimile No.: +44-1980-61-22-41 | |||
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if to Emergent, to: | Emergent BioSolutions, Inc. | ||
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300 Professional Drive | |||
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Gaithersburg, Maryland 20879 USA | |||
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Attention: General Counsel | |||
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Facsimile No.: +1-301-590-1252 | |||
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with a copy to: | Covington & Burling | ||
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One Front Street, 35th Floor | |||
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San Francisco, California 94111 USA | |||
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Attention: James C. Snipes, Esq. | |||
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Facsimile No.: +1-415-591-6091 |
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Emergent BioSolutions, Inc. | Health Protection Agency | |||||||||
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By:
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/s/ Fuad El-Hibri
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By: |
/s/ Pat Troop
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Title: Chairman and CEO | Title: CEO |
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- | 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. |
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(1) | THE WELLCOME TRUST LIMITED a company registered in England under number 2711000 as Trustee of the Wellcome Trust, a charity registered in England under number 210183, whose registered office is at 215 Euston Road, London NW1 2BE (the Trust ); and | |
(2) | MICROSCIENCE HOLDINGS PLC a company registered in England and Wales under number 5106930 whose registered office is at 545 Eskdale Road, Winnersh, Wokingham, Berkshire, RG41 5TU ( Microscience ); and | |
(3) | MICROSCIENCE LIMITED a company registered in England and Wales under number 3270465 whose registered office is at 545 Eskdale Road, Winnersh, Wokingham, Berkshire, RG41 5TU ( Microscience Limited ) |
(A) | Microscience is a company which was incorporated in England as a private company limited by shares on 20 th April 2004 under the provisions of the Companies Act 1985. | |
(B) | At the date of this Agreement, Microscience has an authorised share capital of £4,025,702 divided into [**] A ordinary shares, [**] B ordinary shares, [**] A preferred ordinary shares and [**] B preferred ordinary shares of 5p each all of which have been issued fully paid. | |
(C) | Microscience has invented or acquired a stable formulation for vaccines which may be suitable for development of a novel, single-dose oral typhoid vaccine. | |
(D) | In order to further its charitable objectives, the Trust wishes to make a Programme Related Investment by way of subscribing for ordinary shares in Microscience and providing further funding to Microscience to undertake research and development of Microsciences single-dose, oral typhoid vaccine ( Award ). |
In this Agreement and the Schedules to this Agreement, the following words and phrases shall have the following meanings unless the context requires otherwise: | ||
Affiliate means any entity that, directly or indirectly, through one or more intermediates, is controlled by, controls, or is under common control with a specified entity, and for the purposes of this definition: |
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(a) | the term control means the possession of the power to direct or cause the direction of the management and policies of an entity, whether by ownership of voting stock by partnership interest, by contract or otherwise, including direct or indirect ownership of more than fifty percent (50%) of the voting interest in the specified entity; and | ||
(b) | if at any time an entity no longer controls and is no longer controlled and is no longer under the common control with a Party, this entity will no longer qualify as an Affiliate of that Party as of that time and that Party will have no further obligations on behalf of this former Affiliate under this Agreement; |
Agreement means this agreement; | ||
Application means Microsciences application to the Trust for a Strategic Translation Award which is attached as Schedule 2; | ||
Articles means the articles of association of Microscience, as amended from time to time; | ||
Background Intellectual Property means: |
(a) | the patent applications and patents set out in Schedule 3 and all associated Patent Rights, excluding any claims relating to the method known as signature tagged mutagenesis ; | ||
(b) | the Background Know-How; and | ||
(c) | any and all and copyright relating to typhoid vaccines owned or controlled by Microscience at the Effective Date or at any time thereafter, but excluding the Project Intellectual Property and excluding any copyright relating to the method known as signature tagged mutagenesis ; |
Background Know-How means any and all Know-How relating to the manufacture, development, sale or other exploitation of Microsciences typhoid vaccine which is actually used by Microscience at the Effective Date or at any time thereafter, but excluding the Project Intellectual Property; For the avoidance of doubt, Background Know-How does not include any Know-How relating to the method known as signature tagged mutagenesis; | ||
Board means the board of Directors of Microscience from time to time; | ||
Business Day means a day other than Saturday, Sunday, bank or other public holiday in England; | ||
Change of Control means, in relation to any company, where a person (or persons acting in concert) directly or indirectly, including through any subsidiary or holding company or subsidiary or such holding company: |
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(a) | has beneficial ownership over more than 50 per cent of the total voting rights conferred by all the issued shares in the capital of that company which are ordinarily exercisable in general meeting; or | ||
(b) | has the right to appoint or remove a majority of its directors; or | ||
(c) | has power to direct that the affairs of the company are conducted in accordance with its wishes, |
in each case where such person or persons did not have such beneficial ownership, right or power at the Effective Date; | ||
Combination Product means a product that contains a Product together with one or more other therapeutically or prophylactically active ingredient(s) that are sold either as a fixed dose or as separate doses in a single package; | ||
Competent Authority means any local or national agency, authority, department, inspectorate, minister, ministry official or public or statutory person (whether autonomous or not) of, or of any government of, any country having jurisdiction over this Agreement or any of the Parties or over the development or marketing of vaccine products including the European Commission and the European Court of Justice; | ||
Completion means completion of the matters set out in Clause 2; | ||
Customer means a third party; | ||
Directors means the directors of Microscience appointed pursuant to the Articles; | ||
Documents means paper, notebooks, books, files, ledgers, records, tapes, discs, diskettes, CD-ROMs and any other media on which Know-How can be permanently stored; | ||
Effective Date means the date of this Agreement as set out on page 1; | ||
Encumbrance means any claim, charge, mortgage, security, lien, option, equity, power of sale; hypothecation or other third party rights, retention of title, right of pre-emption, right of first refusal or security interest of any kind; | ||
First Instalment means the amount payable by the Trust to Microscience on Completion as set out in Schedule 1; | ||
Force Majeure means any event or circumstance which is beyond the reasonable control of either Party, which the Party could not reasonably be expected to have taken into account at the Effective Date and which results in or causes the failure of it to perform any or all of its obligations under this Agreement, except that lack of funds shall not be interpreted as a cause beyond the reasonable control of either Party; |
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Instalment means the amount payable by the Trust to Microscience on the achievement by Microscience of a Project Milestone on or before the relevant Project Milestone Date, as set out in Schedule 1; | ||
Key Scientist means a senior member of staff having sufficient knowledge and experience, involved in performing Microsciences obligations under this Agreement; | ||
Know-How means unpatented technical and other information which is not in the public domain including: |
a) | information comprising or relating to inventions, concepts, discoveries, data (including, for the avoidance of doubt, data necessary or desirable for regulatory submission), designs, formulae and ideas; | ||
b) | information relating to Materials; | ||
c) | methods, models, assays, research plans, procedures, designs for experiments and tests; | ||
d) | records and results of experimentation, testing research and development; | ||
e) | processes including manufacturing process, specifications and techniques; | ||
f) | drawings and manuals; | ||
g) | instrumentation; | ||
h) | chemical, pharmacological, toxicological, clinical, analytical and quality control data; | ||
i) | clinical trial data, data analyses, reports or summaries and information contained in submissions to and information from regulatory authorities; and | ||
j) | any Documents containing any of the foregoing |
and the fact that an item is known to the public shall not be taken to exclude the fact that a compilation including the item, and/or a development relating to the item, is not known to the public; | ||
Materials means any chemical or biological substances including any: |
a) | nucleotide or nucleotide sequence including DNA and RNA sequences; | ||
b) | organic or inorganic element or compound; | ||
c) | protein including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or a peptide enzyme or antibody; |
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d) | assay or reagent; | ||
e) | cell line, culture medium; | ||
f) | vaccine; or | ||
g) | any other genetic or biological material; |
Microscience Territory means the countries and territories set out in Schedule 4; | ||
Microscience Option Territory means the countries and territories set out in Schedule 5; | ||
Net Sales means the gross invoiced amount billed for sales of Products to a Customer by Microscience, its Affiliates or licensees, less the following items to the extent they are paid or incurred or allowed and included in the invoice price: |
a) | quantity, trade and/or cash discounts or rebates actually granted or accrued; | ||
b) | 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; | ||
c) | taxes, tariffs, customs duties and surcharges and other governmental charges incurred in connection with the sale, exportation or importation of Products; |
provided that the transfer of Products by Microscience to Affiliates and licensees shall not be considered a sale and in such cases, Net Sales shall be determined on the gross amount invoiced by the Affiliate or licensee on the Customer, less the aforementioned deductions to the extent they are allowed, paid or accrued; | ||
Parties means Microscience and the Trust and Party shall mean either of them; | ||
Patent Rights means patent applications, patents, author certificates, inventor certificates, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them and includes all divisions, renewals, continuations, continuations-in-part, extensions, reissues, substitutions, confirmations, registrations, revalidations and additions of or to them, as well as any supplementary protection certificate, or like form of protection in respect thereof; | ||
Product means the oral typhoid vaccine developed by Microscience including all formulations thereof but for the avoidance of doubt excluding spi -VEC Constructs; | ||
Project means the programme of research and development relating to Microsciences oral typhoid vaccine as further described in the Application including the Project Milestones, Project Milestone Dates and Instalments which are set out in Schedule 1; |
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Project Intellectual Property means Know-How and copyright relating to oral typhoid vaccines invented, created or produced by Microscience as a result of the performance of the Project, together with all Patent Rights relating thereto; | ||
Project Materials means Materials acquired, created, manufactured or used by Microscience for, or during performance of, the Project; | ||
Project Milestone means a milestone set out in Schedule 1, or as subsequently agreed in writing between the Parties, the achievement of which by Microscience on or before the relevant Project Milestone Date, shall trigger the payment to Microscience of the relevant Instalment by the Trust; | ||
Project Milestone Criteria means the objective criteria agreed between the parties and set out at Schedule 1 for determining whether a Project Milestone has been met; | ||
Project Milestone Date means a date for the achievement of a Project Milestone as set out in Schedule 1, or as subsequently revised to a later date in accordance with Clause 3.2; | ||
Quarter means a period of three consecutive calendar months commencing on 1 January, 1 April, 1 July or 1 October in any year and Quarterly shall be construed accordingly; | ||
Royalty means the sums payable by Microscience to the Trust or by the Trust to Microscience under Clauses 6.1, 6.2 and 6.3; | ||
Second Instalment means the amount payable by the Trust to Microscience on the achievement by Microscience of the Second Project Milestone on or before the relevant Second Project Milestone Date, as set out in Schedule 1; | ||
Shareholder means a holder of shares in the capital of Microscience; | ||
Shares means A ordinary shares of £0.05 each in the capital of Microscience; | ||
Site Visit Group means the group of people appointed by the Trust in accordance with Clause 3.11; | ||
spi -VEC Constructs means constructs based on the attenuated typhoid bacterium developed by Microscience that have been further engineered to deliver non-typhoid related antigens; | ||
Subscription Shares means the Shares to which the Trust is entitled to subscribe pursuant to Clauses 8.1 and 8.2; | ||
Third Instalment means the amount payable by the Trust to Microscience on the achievement by Microscience of the Third Project Milestone as set out in Schedule 1; |
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Trust Direct Costs means any costs and expenses directly incurred by the Trust in respect of the commercialisation of the Product, including cost of goods, manufacturing costs, costs of delivery, marketing costs, distribution costs and regulatory costs; | ||
Trust Indirect Costs means any reasonable costs and expenses incurred by the Trust in respect of the commercialisation of the Product other than Trust Direct Costs, including by way of example, costs of an educational health awareness campaign or professional costs incurred in negotiations with governments beyond the normal regulatory process; | ||
Trust Net Receipts means, in relation to any individual Product, the monetary amount received by the Trust which is attributable to sale of that Product by it, its Affiliates or licensees after deduction of Trust Indirect Costs but prior to deduction of the Trust Direct Costs which are attributable to the sale of the relevant Product, and | ||
Trust Territory means those countries and territories which become part of the Trust Territory pursuant to the provisions of Clauses 10.4, 10.5, 10.6, 10.7 or 10.8. | ||
1.1 | In this Agreement: |
1.1.1 | unless the context otherwise requires, all references to a particular Clause or Schedule shall be a reference to that clause in, or schedule to, this Agreement, as it may be amended from time to time pursuant to this Agreement; | ||
1.1.2 | the table of contents and headings are inserted for convenience only and shall be ignored in construing this Agreement; | ||
1.1.3 | unless the contrary intention appears, words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; | ||
1.1.4 | any reference to persons includes natural persons, firms, partnerships, limited liability partnerships, companies, corporations, unincorporated associations, local authorities, governments, states, foundations and trusts (in each case whether or not having separate legal personality) and any agency of any of the above; | ||
1.1.5 | 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; | ||
1.1.6 | any reference to a statute, statutory provision or subordinate legislation ( Legislation ) (except where the context otherwise requires); |
1.1.6.1 | shall be deemed to include any bye-laws, licences, statutory instruments, rules, regulations, orders, notices, directions, consents or permissions made under that Legislation; and |
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1.1.6.2 | shall be construed as referring to any Legislation which replaces, re-enacts, amends or consolidates such Legislation (with or without modification) at any time; |
1.1.7 | any reference to an English legal expression 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 what most nearly approximates in that jurisdiction to the English legal expression; | ||
1.1.8 | any reference to a Party includes a reference to their respective successors-in-title and permitted assignees; | ||
1.1.9 | any obligation imposed upon Microscience may be satisfied by Microscience or by its wholly owned subsidiary, Microscience Limited; and | ||
1.1.10 | any statement that a licence is granted or is to be granted by Microscience shall mean that the licence is granted or is to be granted by Microscience or Microscience Limited. |
2.1 | Completion shall take place immediately following execution of this Agreement by both Parties. | |
2.2 | The Trust shall pay to Microscience the First Instalment within ten (10) Business Days of Completion. |
3.1 | Microscience shall further develop a single-dose, oral typhoid vaccine in accordance with the work plan set out in the Application and shall use its reasonable endeavours to achieve each Project Milestone on or before the relevant Project Milestone Date. The Parties acknowledge that unforeseen circumstances and technical issues can affect the progress of any scientific research and development work and could delay the achievement of any of the Project Milestones. | |
3.2 | Microscience hereby undertakes diligently to perform the research and development work and other tasks, including project management of the Project, as set out in the Application. In the event that Microscience fails to achieve a Project Milestone on or before the relevant Project Milestone Date, the Parties shall meet to discuss the matter and, provided Microscience has acted diligently in its work towards the Project Milestone, the Parties shall change the relevant Project Milestone Date to a later date which would, realistically, give Microscience sufficient time to achieve the Project Milestone by the new date. | |
3.3 | If there is any disagreement between the Application and the terms of this Agreement, the terms of this Agreement shall prevail. |
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3.4 | Microscience undertakes to use all funding received from the Trust pursuant to this Agreement solely for the purposes of the Project. Microscience shall obtain the Trusts prior written consent to any other use of any funding received from the Trust pursuant to this Agreement. | |
3.5 | Upon achievement by Microscience of a Project Milestone in accordance with the Project Milestone Criteria on or before the relevant Project Milestone Date, Microscience shall notify the Trust of such achievement in writing ( Project Milestone Notice ). The Project Milestone Notice shall specify the relevant Project Milestone and shall give reasonable details as to how the specified Project Milestone has been achieved. | |
3.6 | If Microscience has achieved the relevant Project Milestone by the relevant Project Milestone Date, the Trust shall, within thirty (30) days of receipt of an invoice from Microscience, pay the relevant Instalment set out in Schedule 1 to Microscience by transfer of funds to the bank account referred to in Clause 6.8. | |
3.7 | If the Trust believes that Microscience has not achieved the specified Project Milestone on or before the relevant Project Milestone Date, it shall, within thirty (30) days of receipt of the relevant invoice, inform Microscience of its reasons and the Parties shall meet to discuss the matter. If the Parties fail to settle the matter at such meeting, the matter shall be dealt with in accordance with the procedure set out in Clause 22. | |
3.8 | At the end of each Quarter following the Effective Date, Microscience shall provide the Trust with a summary written report on the progress made and results obtained in performance of the Project during that Quarter. | |
3.9 | As and when required, but not less than twice per calendar year, the Head of Business Development, Technology Transfer Division of the Trust or his nominee and Rod Richards, Chief Executive Officer of Microscience, shall meet to discuss the progress made by Microscience on the Project. | |
3.10 | The obligations of Clauses 3.1, 3.2, and 3.4 shall be considered to be material obligations for the purposes of Clause 15. | |
3.11 | The Trust at its sole cost, shall be entitled to establish and appoint up to four members of a group ( Site Visit Group ) which, upon reasonable notice to Microscience, shall be permitted twice per calendar year to visit each of Microsciences facilities where Project work is being carried out and sites where any Project clinical trials are being conducted and meet a Key Scientist for the purpose of updating the Trust on the progress of the Project. Microscience may suggest to the Trust appropriate candidates for appointment to the Site Visit Group, but the decision to appoint, or replace, any individual shall be at the Trusts sole discretion. | |
3.12 | At the Effective Date, the Key Scientist is [**]. If Microscience intends to appoint an additional Key Scientist or a replacement for a Key Scientist involved in performing Microsciences obligations under this Agreement, it shall, prior to such appointment, seek the Trusts written approval to the appointment. However the Trust shall not unreasonably withhold its consent to such an appointment. |
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4.1 | All Project Intellectual Property (including data produced in the course of performing the Project) shall be owned solely by Microscience. | |
4.2 | Microscience shall be responsible, at its sole cost, for filing, prosecuting and maintaining all Patents Rights which are Project Intellectual Property. Microscience shall consult the Trust on all material aspects of the filing, prosecution and maintenance of such Patent Rights and shall consider in good faith all reasonable representations made by the Trust in relation thereto. Microscience shall keep the Trust informed of all Patent Rights which are Project Intellectual Property and which are granted and the progress of all applications relating to those Patent Rights. | |
4.3 | If Microscience chooses not to pursue filing, prosecution or maintenance of any Patent Rights which are Project Intellectual Property in any country, it shall immediately notify the Trust of this fact in writing. The Trust shall be entitled, but not obliged, at its own cost, to pursue or maintain such Patent Rights in the relevant country or countries in Microsciences name and, subject to payment by the Trust of Microsciences reasonable costs, Microscience shall provide such assistance to the Trust as may be reasonably be required by the Trust. | |
4.4 | Microscience shall not enforce its rights under any Project Intellectual Property for infringement or potential infringement by: |
4.4.1 | any not-for-profit or charitable organisation which is conducting non-commercially sponsored research; | ||
4.4.2 | any person carrying out non-commercially sponsored research on behalf of any not-for-profit or charitable organisation. |
4.5 | This Clause 4 shall not prevent Microscience enforcing its rights under any Background Intellectual Property. | |
4.6 | Microscience hereby grants to the Trust a non-exclusive, worldwide, royalty-free, perpetual, irrevocable, sub-licenseable licence under all its right, title and interest in and to the Project Intellectual Property to conduct non-commercial research. |
5.1 | To the extent that it is commercially viable to do so, Microscience shall use its reasonable endeavours, itself or through its Affiliates or licensees, to: |
5.1.1 | advertise, promote, demonstrate, market, sell and distribute the Product in the Microscience Territory; | ||
5.1.2 | maximise the use, sales and penetration in the market of the Product in the Microscience Territory; and |
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5.1.3 | actively promote and develop market opportunities for the Product in the Microscience Territory. |
For the avoidance of doubt the costs of the activities described in this Clause 5.1 shall not be borne by the Trust. | ||
5.2 | The Trust shall use its reasonable endeavours throughout the Trust Territory to ensure that it fulfils its charitable objectives by taking such action as it reasonably anticipates will result in a substantial uptake of the Product in the Trust Territory. For the avoidance of doubt the costs of the activities described in this Clause 5.2 shall not be borne by Microscience. |
6.1 | Microscience shall pay the Trust a Royalty of [**]% of all lump sum or milestone payments received by Microscience in connection with the grant of any licence to a third party to develop, manufacture, sell, distribute or supply the Product, where such lump sum or milestone payments are payable upon the signature of the agreement granting the licence or are payable upon the achievement of technical development milestones prior to the first commercial sale of the Product. | |
6.2 | Microscience shall pay the Trust a Royalty on all worldwide Net Sales of Product by Microscience, its Affiliates and licensees (excluding sales to or by the Trust or its Affiliates) during the first ten years following the end of the first Quarter in which the first invoices to Customers for sales of Product became due, as follows. Where such Net Sales in any calendar year are less than US$ [**], the Royalty rate shall be [**]%. Where such Net Sales in any calendar year are greater than US$ [**], the Royalty rate shall be [**]% for the first US$ [**] of Net Sales, [**]% for the Net Sales in the range US$ [**] to US$ [**] and [**]% for any Net Sales in excess of US$ [**] in the calendar year concerned. | |
6.3 | The Trust shall pay Microscience a Royalty of [**]% of Trust Net Receipts during the first 10 years following the end of the first Quarter in which the first Product is made available by the Trust, its Affiliates or licensees. | |
6.4 | If: |
6.4.1 | any sale or other disposal of Product by Microscience, its Affiliates or its licensees to a third party is other than in a bona fide arms length transaction exclusively for money; or | ||
6.4.2 | any Product is sold or disposed of by Microscience, its Affiliates or its licensees or allowed by Microscience, its Affiliates or its licensees to be used for consideration other than cash, |
then such sale, disposal or use shall be deemed to be a sale for the purposes of Clause 6.2 at the relevant open market price in the country in which the sale, disposal or use occurs. If such open market price is not ascertainable, a reasonable price shall be assessed based |
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on an arms length basis or the value of the goods or services provided in exchange for the supply of the Product. | ||
6.5 | With respect to Combination Products sold or disposed of by Microscience, its Affiliates or licensees, the Net Sales used for the calculation of the Royalties under Clause 6.2 shall be determined as follows: | |
A/(A + B) x (Net Sales of the Combination Product), where: |
A= | standard sales price of the Product, containing the same amount of the oral typhoid vaccine as the sole active ingredient as the Combination Product in question, in the given country; and | ||
B= | standard sales price of the ready-for-sale form of a product containing the same amount of the other therapeutically active ingredient(s) that is contained in the Combination Product in question, in the given country |
provided that if, in a specific country: (a) the other therapeutically active ingredient(s) in such Combination Product are not sold separately in such country, Net Sales shall be adjusted by multiplying actual Net Sales of such Combination Product by the fraction A/C, where C is the standard sales price in such country of such Combination Product; and (b) if a Product is not sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction (C-B)/C, where B is the standard sales price in such country of the other therapeutically active ingredient(s) in the Combination Product and C is the standard sales price in such country of the Combination Product. The standard sales price for the Product and for each other active ingredient shall be for a quantity comparable to that used in such Combination Product and of the same class, purity and potency. If, in a specific country, both a Product and a product containing the other active ingredients in such Combination Product are not sold separately, a market price for such Product and such other active ingredients shall be negotiated by the Parties in good faith based upon the costs, overhead and profit as are then incurred for such Combination Product and all products then being made and marketed by Microscience and having an ascertainable market price that are comparable to such Product or such other active ingredients, as applicable. If, in a specific country, the foregoing calculations do not fairly represent the value of the various active ingredients included in a Combination Product, the allocation of Net Sales for such Combination Product shall be negotiated by the Parties in good faith. | ||
6.6 | The Parties acknowledge that Microscience may be liable to pay royalties and make other payments to third parties in respect of the development, manufacture or sale of Product and that the Trust may be liable to pay royalties and make other payments to third parties in respect of the manufacture or sale of Product. The Parties agree that each Party shall be solely responsible, at its own cost, for all such payments to third parties and any Royalties payable under this Agreement shall not be reduced as a consequence. |
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6.7 | Unless otherwise agreed between the Parties in writing, all payments due to the Trust under this Agreement shall be made in pounds sterling to the following account: |
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Account Name: | The Wellcome Trust | ||
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Account Number: | [**] | ||
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Bank: | HSBC Bank Plc | ||
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Sort Code: | 40-03-28 | ||
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Swift: | MIDLGB21 | ||
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Branch Address: | 31 Holborn Circus, London, EC1N 2HR. |
6.8 | Unless otherwise agreed between the Parties in writing, all payments due to Microscience under this Agreement shall be made in pounds sterling to the following account: |
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Account Name: | MICROSCIENCE LIMITED | ||
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Account Number: | [**] | ||
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Bank: | BARCLAYS | ||
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Sort Code: | 20-72-17 | ||
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Branch Address: |
Richmond & Twickenham Business Centre,
PO BOX 13, 8 George Street Richmond, TW9 1JU |
6.9 | Within 150 days of the end of each Quarter, each Party shall deliver a statement to the other Party setting out all sales of Product made in the relevant Quarter by that Party, its Affiliates and licensees and the amount of Royalty which is due to the other Party ( Quarterly Statement ). Each Party shall deliver to the other Party an invoice for the amount due to it as set out in the Quarterly Statement. The Royalty amount invoiced shall be payable to the other Party within thirty days of receipt of the invoice. | |
6.10 | Where sales of Product on which Royalty payments are payable under Clauses 6.1, 6.2 or 6.3 are invoiced or calculated in a currency other than pounds sterling, conversion into pounds sterling shall be calculated by reference to the relevant foreign exchange selling rate for the currency in which they are invoiced or calculated of the Financial Times newspaper at the close of business in London on the last day of the Quarter to which the Royalty relates. | |
6.11 | If either Party does not receive payment of any sums due to it under this Clause 6 within the time specified, interest shall accrue on such sums at the rate equivalent to three per cent (3%) per annum over the then current base rate of HSBC bank, calculated on a daily basis. | |
6.12 | If, for any reason, either Party ( Payee ) does not receive by the due date any amount due to it from the other Party ( Payer ) in accordance with the terms of this Agreement, the Payee shall be entitled to off-set the amount due (together with any interest payable thereon in accordance with Clause 6.11) against any amount which the Payee is due to pay to the Payer. |
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6.13 | All payments under this Agreement are expressed to be exclusive of goods, sales, value added or any similar tax ( Value Added Tax ) howsoever arising, and the Party obliged to make payment shall pay the other Party, in addition to those payments, all Value Added Tax for which the other Party is liable to account to any Competent Authority in relation to any supply made or deemed to be made for Value Added Tax purposes pursuant to this Agreement. The Party obliged to make payment shall pay any payments due to the other Party under this Clause 6.13 at the same time as the relevant payment is due under this Agreement. | |
6.14 | If either Party is required by law to make any withholding or similar tax payment on behalf of the other Party, with respect to any of the payments to be made to the other Party under this Agreement, the amount of such required withholding or tax payment shall be deducted from the amount of payments otherwise due to the other Party and paid or deposited by the paying Party in accordance with the applicable law. | |
6.15 | With respect to such deduction and payment of any withholding or similar taxes required under clause 6.14, the paying Party shall provide such assistance to the other Party as may be reasonably necessary to enable or assist the other Party to claim exemption therefrom or (if that is not possible) to obtain a credit for the deduction or withholding under any applicable double taxation or similar agreement from time to time in force, and shall provide the other Party with proper evidence as to the payment of such tax. | |
6.16 | The obligation on each Party to pay the other Party the Royalties in accordance with Clauses 6.1, 6.2 and 6.3 shall be material obligations of this Agreement for the purposes of Clause 15. |
7.1 | Each Party shall: |
7.1.1 | keep true and accurate records and books of account for six years following the end of the calendar year to which they relate; and | ||
7.1.2 | procure that its Affiliates and licensees shall keep true and accurate records and books of account for three years following the end of the calendar year to which they relate, |
which contain all data necessary for the calculation of the Royalties payable by it to the other Party ( Books ). | ||
7.2 | Once per calendar year following the Effective Date, each Party may request that an independent accountant of its choice be allowed to certify any Quarterly Statements of the other Party, provided always that each individual Quarterly Statement may be certified only once. | |
7.3 | Each Party shall, and shall procure that its Affiliates and licensees shall, make available to the independent accountant all Books which are required for the purpose of certifying the relevant Quarterly Statement, provided that the independent accountant agrees to be |
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bound by terms of confidentiality and non-use which are no less onerous than the terms of Clause 14. The Quarterly Statements so certified shall be final and binding between the Parties. | ||
7.4 | If any Quarterly Statement is shown to have underestimated the monies payable by more than five percent (5%), the cost of the certification shall be the responsibility of the Party shown to have underpaid. Otherwise, the cost shall be the responsibility of the Party requesting the certification. | |
7.5 | Any outstanding payments which are identified as a result of carrying out the certification (including interest payments thereon under Clause 6.11) shall be paid immediately. |
8.1 | In consideration of and upon payment of the First Instalment being made by the Trust, Microscience shall, subject to obtaining any necessary regulatory approvals, within 45 days of the date of payment, allot and issue to the Trust [**] Shares. The nominal subscription price for such Shares shall be £[**] per Subscription Share. Microscience undertakes to obtain any regulatory approvals required for the issue of the Subscription Shares as soon as practicable. | |
8.2 | In consideration of and upon payment of the Third Instalment being made by the Trust, Microscience shall, subject to obtaining any necessary regulatory approvals, within 45 days of the date of payment, allot and issue to the Trust [**] Shares. The nominal subscription price for such Shares shall be £[**] per Subscription Share. Microscience undertakes to obtain any regulatory approvals required for the issue of the Subscription Shares as soon as practicable. | |
8.3 | Microscience warrants that it has obtained all board, shareholder and other approvals and consents required for it to enter into this Agreement and issue the Subscription Shares to the Trust in accordance with this Agreement. | |
8.4 | If Microscience Shares are admitted to trading on the Alternative Investment Market of the London Stock Exchange, the main London Stock Exchange or any recognised investment exchange and such admission becomes effective in accordance with the relevant rules of the London Stock Exchange (or relevant recognised exchange), Microscience shall ensure that all Shares allotted to, or to be allotted to, the Trust in accordance with this Agreement are also admitted to trading on the Alternative Investment Market of the London Stock Exchange, the main London Stock Exchange or the relevant recognised investment exchange, as the case may be. In connection with the admission to trading, Microscience shall provide such information and documents, pay all fees and execute and deliver all such documents as shall be necessary and shall generally do and procure to be done all such things as may properly be required so as to enable admission to take place. |
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9.1 | In Microsciences first investment round subsequent to the Effective Date, where such round is led by an institutional investor, or venture capital fund manager that is a member of the British Venture Capital Association or an overseas equivalent, Microscience may propose (but is not obliged to propose) that the Trust participate in such investment round in an amount not exceeding ten per cent (10%) of such investment round. If Microscience makes such a proposal, it shall do so when the terms of the investment round have been agreed with other potential investors. If the Trust participates in the investment round, the Trust shall subscribe for the same class of shares at the same price per share as other investors, or enter into an instrument convertible into shares on the same terms as other investors. For this purpose, the Company will provide the Trust access to Company information that is appropriate for a potential investor. | |
9.2 | If Microscience wishes to raise further funding in respect of the Project, it shall promptly inform the Trust in writing, including reasonable details of the funding required, and may make an application to the Trust for funding. The Trust will consider such application but, for the avoidance of doubt, shall have no obligation to grant Microscience any further funding. |
10.1 | The Parties have agreed to divide the world into the Microscience Territory, the Microscience Option Territory and the Trust Territory. | |
10.2 | Microscience shall have the sole right, itself or through its Affiliates or licensees, to make, have made, sell, offer to sell, use, import, export and keep Product in the Microscience Territory. | |
10.3 | Except as provided in Clause 10.11, Microscience shall have the sole right, itself or through its Affiliates or licensees, to make, have made, sell, offer to sell, use, import, export and keep Product in the Microscience Option Territory. | |
10.4 | Subject to Clause 10.6, if within the period of [**] years commencing on the date of the first commercial sale of Product anywhere in the world (the [**] Year Period ), Microscience has not: |
10.4.1 | provided the Trust with a credible business plan which provides for the sale of Product in any particular country within the Microscience Option Territory (which Microscience intends to implement within [**] years of delivery of its business plan to the Trust); or | ||
10.4.2 | granted a licence to a third party which provides for the sale of Product in any particular country within the Microscience Option Territory; or | ||
10.4.3 | sold Product in any particular country within the Microscience Option Territory |
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and the Trust provides Microscience with a credible business plan providing for sale of Product in that country (which the Trust intends to implement), that country shall cease to be part of the Microscience Option Territory and shall be deemed to be part of the Trust Territory. [**] months after the commencement of the [**] year period referred to in Clause 10.4.1, Microscience shall, upon request by the Trust, report on its progress towards implementing the business plan in the country concerned. |
10.5 | If Microscience decides, at any time during the [**] year period referred to in Clause 10.4.1, that it is no longer interested in commercialising Product in the country concerned, it shall forthwith inform the Trust accordingly and, if the Trust provides Microscience with a credible business plan providing for sale of Product in that country (which the Trust intends to implement), that country shall cease to be part of the Microscience Option Territory and shall be deemed to be part of the Trust Territory. | |
10.6 | With respect to any particular country within the Microscience Option Territory, Microscience may extend the [**] Year Period set out in Clause 10.4 to a period of [**] years commencing on the date of the first commercial sale of Product anywhere in the world by giving written notice to the Trust within the [**] Year Period, provided that: |
10.6.1 | Microscience shall not unreasonably exercise its right to extend the [**] Year Period and thereby block the Trusts access to the relevant country for the two year extension period; and | ||
10.6.2 | Microscience demonstrates every six months during the two year extension of the [**] Year Period that it is taking steps towards the sale of Product in the relevant country at a reasonable rate. If the Parties do not agree on whether Microscience has satisfied the requirements of this sub-clause 10.6.2, the dispute shall be resolved in accordance with Clause 22. |
10.7 | If no commercial sale of a Product has taken place in any country in the Microscience Territory or the Microscience Option Territory within the period of 12 years commencing on the Effective Date and Microscience has not: |
10.7.1 | provided the Trust with a credible business plan which provides for the sale of Product in any particular country within the Microscience Option Territory (which Microscience intends to implement within [**] months of delivery of its business plan to the Trust); or | ||
10.7.2 | granted a licence to a third party which provides for the sale of Product in any particular country within the Microscience Option Territory |
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10.8.1 | granted a licence to a third party which provides for the sale of Product in any particular country within the Microscience Option Territory; or | ||
10.8.2 | sold Product in any particular country within the Microscience Option Territory |
and the Trust provides Microscience with a credible business plan providing for sale of Product in that country (which the Trust intends to implement), that country shall cease to be part of the Microscience Option Territory and shall be deemed to be part of the Trust Territory. | ||
10.9 | The Trust may at any time propose that it be licensed to commercialise the Product in countries of the Microscience Territory on such terms as the Trust wishes to put forward but Microscience shall not have any obligation to agree to any such proposals or to discuss or negotiate with the Trust concerning such proposals. | |
10.10 | Microscience hereby grants to the Trust, subject to the provisions of this Agreement, a licence under the Project Intellectual Property and the Background Intellectual Property to: |
10.10.1 | make, dispose of, offer to dispose of, use and keep Product in the Trust Territory and to import and export Product between countries in the Trust Territory; and | ||
10.10.2 | carry out commercial research and development in relation to the manufacture of the Product in any countries in the Trust Territory and the Microscience Option Territory. For the avoidance of doubt, the Trust shall not have any rights under this Agreement to perform signature tagged mutagenesis. |
The licence granted under Sub-Clause 10.10.1 shall be an exclusive licence of Microsciences rights under the Project Intellectual Property and the Background Intellectual Property for the purposes mentioned in Sub-Clause 10.10.1 and the licence granted under Sub-Clause 10.10.2 shall be non-exclusive. The Trust may make Product in the Microscience Territory if it obtains Microsciences prior written consent, but Microscience shall not have any obligation to grant such consent. | ||
10.11 | In the event that the Trust wishes to manufacture and keep Product in a country of the Microscience Option Territory or the Trust wishes to transport Product through a country of the Microscience Option Territory solely for the purposes of exporting that Product to, and using and disposing of that Product in, countries of the Trust Territory, the Trust shall notify Microscience accordingly. Provided that: | |
(a) it would be lawful under the laws of that country for Microscience to grant a licence to the Trust under the Project Intellectual Property and the Background Intellectual Property allowing the Trust to manufacture and keep the Product in that country (or allowing the Trust to transport Product through that country) solely for export and prohibiting the Trust and any sub-licensees from selling, using or disposing of the Product in that country; and |
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10.14.1 | the Trust shall promptly notify Microscience of the execution of any sub-licence agreement and shall at the request of Microscience promptly provide Microscience with a true and complete copy of the sub-licence agreement; | ||
10.14.2 | the provisions contained in any sub-licence agreement shall be consistent with the provisions of this Agreement; | ||
10.14.3 | the sub-licence agreement shall prohibit further sub-licensing by the sub-licensee provided that further sub-licensing shall be permitted with Microsciences prior written consent, but Microscience shall not have any obligation to grant such consent, and | ||
10.14.4 | the Trust shall at all times ensure the observance and performance by each sub-licensee of the provisions of the sub-licence and indemnify Microscience against any loss, damages, costs, claims or expenses which are awarded against or incurred by Microscience as a result of any breach by any sub-licensee of any of the provisions of the sub-licence, as if the breach had been that of the Trust. |
10.15 | Microscience shall: |
10.15.1 | upon request, deliver to the Trust, or to a person nominated by the Trust (if that person has entered into a confidentiality agreement with Microscience), all Know-How comprised in the Project Intellectual Property, Background Know- |
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How and Materials reasonably required by the Trust to exercise the Trusts rights under the licence granted under Clause 10.10; and | |||
10.15.2 | upon request, provide to the Trust, or to a person nominated by the Trust (if that person has entered into a confidentiality agreement with Microscience), at the Trusts sole cost, at least 24 person-days of scientific support at the Trusts or the nominated persons premises, at a time mutually agreed between the Parties to enable the Trust to exercise its rights under the licence granted under Clause 10.10. The Trust shall pay to Microscience within 30 days of receipt of an invoice from Microscience the costs of such scientific support charged at industry standard rates plus overhead and any necessary travelling and hotel expenses relating to such scientific support. |
10.16 | Microscience shall have the option of proposing that it supplies the Trusts requirements of Product for distribution within the Trust Territory at a price or at prices to be agreed between the Parties, but Microscience shall have no obligation to supply Product to the Trust and the Trust shall have no obligation to purchase Product from Microscience. | |
10.17 | Product produced and distributed by the Trust, its Affiliates or licensees in the Trust Territory shall be manufactured according to the same manufacturing process, and shall be comparable to, Product produced and sold by Microscience, its Affiliates or licensees in the Microscience Territory. Determinations of Product comparability shall be based on the product release and characterisation specifications and associated assays that Microscience uses to release its own Product. All costs associated with determining Product comparability (including the costs of the necessary transfer of assays) shall be borne by the Trust. If Microscience, its Affiliates or licensees discontinue the manufacture and sale of the Product due to termination of this Agreement, the Product produced and distributed by the Trust, its Affiliates or licensees shall be an oral typhoid vaccine (excluding spi- VEC Constructs). Product sold or supplied by the Trust, its Affiliates or licensees shall have packaging which is substantially different from that used by Microscience (save that the Trust shall not be obliged to make alterations to its existing packaging if Microscience changes its own packaging), and shall be labelled with the words Product sold under licence from Microscience Holdings PLC. | |
10.18 | Microscience hereby grants to the Trust a non-exclusive, royalty free, sub-licenseable licence throughout the Trust Territory, for a period of time equivalent to the term of the licence granted to the Trust under Clause 10.10, to use Microsciences trade mark MICROSCIENCE solely to label Product with the wording given in Clause 10.17 in order to comply with the provisions of Clause 10.17. |
11.1 | Each Party shall ensure that each employee working on the Project or performing other obligations under this Agreement is employed under a contract compliant with all relevant laws and regulations. |
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11.2 | Microscience shall be responsible for the management, monitoring and control of all research, development, regulatory, commercialisation, marketing, distribution and sales work undertaken pursuant to this Agreement except where the Trust undertakes any such work in accordance with Clauses 5.2 or 10. In performing the obligations imposed on it by this Agreement, each Party shall comply with the requirements of all applicable laws and regulatory authorities governing the use of radioactive isotopes, animals, pathogenic organisms genetically modified organisms (GMOs), toxic and hazardous substances, research on human subjects and human embryos, and include appropriate ethical approvals and consents, including for example but not limited to, such approvals and consents for obtaining tissues and other human samples. | |
11.3 | Except in accordance with Clauses 5.2 and 10, the Trust shall have no obligation, express or implied, to supervise, monitor, review or otherwise assume responsibility for the production, manufacture, testing, marketing, sale or disposal of any Product. |
12.1 | Microscience shall not use the Wellcome Trust name or logo except with the prior written consent of the Trust and in the manner approved by the Trust and the Trust shall not use the name or logo of Microscience except with the prior written consent of Microscience and in the manner approved by Microscience. | |
12.2 | Neither Party shall disclose any of the terms of this Agreement to any person other than to its professional advisors, except that Microscience may disclose the terms of this Agreement to other persons to the extent required in connection with any fundraising of Microscience and provided Microscience makes such disclosure under terms of confidentiality. | |
12.3 | Subject to Clauses 12.4 and 12.5, neither Party may issue any press release or public announcement regarding this Agreement without the other Partys prior written consent. When requesting such consent from the other Party, each Party shall submit all of the proposed content of any such press release or public announcement at least ten days before its proposed release. | |
12.4 | Clause 12.3 shall not apply if and to the extent that such public announcement is required by: |
12.4.1 | law; or | ||
12.4.2 | any securities exchange or regulatory or governmental body having jurisdiction over it (including but not limited to the London Stock Exchange, the Panel on Takeovers and Mergers and the Serious Fraud Office) and whether or not the requirement has the force of law |
and provided that any such announcement shall be made only after consultation with the other Party. |
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12.5 | Microscience may issue the press release set out in Part A of Schedule 6 upon Completion and the Trust shall be permitted to use the statement set out in Part B of Schedule 6 in its annual report, reviews and summaries of awards. |
13.1 | Each Party warrants to the other Party that: |
13.1.1 | it has legal power, authority and right to enter into this Agreement and to perform its respective obligations hereunder; | ||
13.1.2 | it is not at the Effective Date a party to any agreement, arrangement or understanding with any third party which in any significant way prevents it from fulfilling any of its material obligation hereunder; | ||
13.1.3 | this Agreement has been duly authorised, executed, and delivered by that Party and is valid, binding, and legally enforceable obligation of that Party; | ||
13.1.4 | no consent, approval, authorisation, or order of any court or governmental agency or body is required for the consummation of the transactions contemplated by this Agreement (except that the manufacture, use, distribution and sale of Product will require regulatory approval); and | ||
13.1.5 | the execution, delivery, and performance of this Agreement will not result in a breach or violation of, or constitute a default under, any statute, regulation, or other law or agreement or instrument to which it is a party or by which it is bound, or any order, rule, or regulation of any court or governmental agency or body having jurisdiction over it or any of its properties. |
13.2 | Microscience and Microscience Limited represent and warrant to the Trust that: |
13.2.1 | Microscience Limited is the sole legal and beneficial owner and, where registered, the sole registered proprietor of all patent applications and patents set out in Schedule 3 free from all Encumbrances, except as set out in Schedule 3; | ||
13.2.2 | Microscience Limited has the right to disclose the Background Know-How to the extent required by Clause 10.15.1; | ||
13.2.3 | as far as they are aware, the Background Intellectual Property comprises all the materially significant intellectual property rights required by the carrying on of the Project as set out in this Agreement; | ||
13.2.4 | Microscience Limited is able to grant to the Trust the licences under the Background Intellectual Property as set out in Clause 10; | ||
13.2.5 | as far as they are aware, the patent applications and patents set out in Schedule 3 are valid and enforceable and not subject to any pending or threatened claims, challenges or proceedings; |
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13.2.6 | as far as they are aware, no third party has made unauthorised use of any Background Intellectual Property, nor threatened to do so; | ||
13.2.7 | as far as they are aware, Microscience Limited has taken all steps and made all payments which are required to prosecute, maintain and renew the patent applications and patents set out in Schedule 3 within the required timescales; and | ||
13.2.8 | as far as they are aware, none of the activities of Microscience or Microscience Limited relating to typhoid vaccines infringe, or have been alleged to infringe, the intellectual property rights of any third party. |
13.3 | Save as provided in this Clause 13, nothing in this Agreement shall be deemed to be, or construed as, a representation or warranty by Microscience or Microscience Limited: |
13.3.1 | as to the accuracy, safety, efficacy, or usefulness, for any purpose, of any matter claimed in any of Microscience Limiteds Patent Rights which are Background Intellectual Property; | ||
13.3.2 | that any patent will issue based upon any pending patent application included in the Background Intellectual Property, or | ||
13.3.3 | that any patent included in the Background Intellectual Property which issues will be valid. |
13.4 | Subject to Clause 13.5, neither Party shall be liable to the other of any of the other Partys Affiliates, licensees or sublicensees for any of the following types of loss, damage, cost or expense arising (whether in contract, tort, negligence, breach of statutory duty or otherwise) under or in relation to this Agreement or the subject-matter of this Agreement: |
13.4.1 | any loss of profits, business, contracts, anticipated savings, goodwill, or revenue; | ||
13.4.2 | any loss or corruption of data; or | ||
13.4.3 | any indirect or consequential loss or damage whatsoever, |
even if that Party was advised in advance of the possibility of such loss or damage. | ||
13.5 | Nothing in Clause 13.4 shall prohibit or hinder the exercise of either Partys rights in respect of any of the following matters, notwithstanding that any loss or damage that Party may be seeking to recover is of the type referred to in Clause 13.4: |
13.5.1 | death and personal injury caused by negligence of the other Party; and | ||
13.5.2 | any liability for fraud or fraudulent misrepresentation. |
13.6 | Each Party shall be responsible for and indemnify and keep fully indemnified the other Party and its Affiliates, officers, servant, agents, licensees and sublicensees (collectively the Indemnified Party ) against any and all liability, loss, damage, cost or expense |
23
( Losses ) incurred or suffered by the Indemnified Party as a result of any claim by a third party arising directly out of the research, development, marketing, sale, commercialisation or distribution of the Product by, or on behalf of, that Party, except to the extent such Losses result from the negligence or intentional misconduct of the Indemnified Party (including, in particular, any act or omission by the Indemnified Party which is not in accordance with the product release and characterization specifications referred to in Clause 10.17). | ||
13.7 | Each Party shall maintain, at its sole cost, adequate general and product liability insurance for such period as that Party continues to supply Product pursuant to this Agreement plus three years, and shall ensure that the other Partys interest is noted on the policy, if so requested by the other Party. Each Party shall promptly, on request, supply the other Party with a copy of each such policy of insurance. | |
13.8 | Each Party shall promptly inform the other Party of, and deliver comprehensive written details to the other Party of any safety or environmental concerns or issues reportable to, or raised by, any Competent Authority which relate to the Product or other oral vaccine using Microscience technology which might have an impact on the Product. Upon request of either Party, the other Party shall use all reasonable endeavours to assist that Party in taking any action with respect to the Product which is necessary or reasonably desirable as a consequence of those safety or environmental concerns or issues. | |
13.9 | In the event that either Party (the First Party ) intends to seek indemnification under Clause 13.6, it shall promptly inform the other Party (the Second Party ) and the First Party shall permit the Second Party and/or its insurers to direct and control the defence of the claim, which shall use independent legal representation for the First Party where reasonably necessary. The First Party shall provide such reasonable assistance as reasonably requested by the Second Party (at the Second Partys cost) in the defence of the claim, provided always that nothing in this Clause 13.9 shall permit the First Party to make any admission on behalf of the Second Party, or to settle any litigation without the prior written consent of, the Second Party, which consent is not to be unreasonably withheld or delayed (except that the Second Party may always withhold such consent on the instructions of its insurers). | |
13.10 | The rights, powers and remedies provided in this Agreement are (except as expressly provided) cumulative and not exclusive of any rights, powers and remedies provided by law, or otherwise. |
14.1 | The Trust undertakes and agrees not at any time, for any reason whatsoever, to disclose, or permit to be disclosed, to any third party, or otherwise make use of, or permit use to be made of (except as expressly permitted by this Agreement) any trade secrets or confidential information relating, amongst other things, to: |
14.1.1 | Microsciences technology; | ||
14.1.2 | the business affairs or finances of Microscience; or |
24
14.1.3 | the business affairs or finances of any Affiliate, licensee, sublicensee, supplier, agent, distributor or customer of Microscience |
( Confidential Information ) which comes into its possession pursuant to this Agreement. | ||
14.2 | This Clause 14 shall apply to the Background Intellectual Property and the Project Intellectual Property on the basis that it is Confidential Information owned by Microscience such that, except so far as is reasonably necessary for the Trust to exploit any Licence granted to it in accordance with Clause 10, the Trust shall not disclose it without the consent of Microscience, or otherwise than in accordance with the provisions of this Clause 14. | |
14.3 | The Trust shall ensure that only those of its officers and employees and those of its licensees, sublicensees, potential licensees or sublicensees and Affiliates who have a need to know for the purposes of carrying out this Agreement are given access to Microsciences Confidential Information and that all such persons, prior to the disclosure of Confidential Information to them, agree to be bound by the obligations of the Trust under this Clause 14. The Trust shall enforce such obligations of all such persons. | |
14.4 | The obligations of confidence referred to in this Clause 14 shall not extend to any Confidential Information which: |
14.4.1 | is at the time of disclosure, or thereafter becomes, generally available to the public otherwise than by reason of a breach by the recipient of the provisions of this Clause 14; | ||
14.4.2 | is known to the recipient without obligations of confidence prior to its receipt from the disclosing Party, as can be shown by written record; | ||
14.4.3 | is subsequently disclosed to the recipient without obligations of confidence by another party owing no such obligations in respect thereof; | ||
14.4.4 | is required to be disclosed by any applicable law or any Competent Authority to which the recipient is from time to time subject; or | ||
14.4.5 | is independently developed by a person or persons with no access to the Confidential Information disclosed by the disclosing Party, as demonstrated by written records, |
but the fact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public. | ||
14.5 | The obligations of the Trust (and all persons referred to in Clause 14.3) under this Clause 14 shall survive until ten years after the expiry or termination for whatever reason of this Agreement. |
25
14.6 | Each Party undertakes that, prior to any of its Affiliates ceasing to be an Affiliate, it will procure that any such Affiliate that holds Confidential Information of the other Party will give confidentiality and non-use undertakings to the other Party on terms no less onerous than the terms of this Clause 14. |
15.1 | This Agreement shall come into effect on the Effective Date and, subject to earlier termination in accordance with this Clause 15, shall continue in full force until the expiry of all rights and obligations hereunder. | |
15.2 | Either Party ( Terminating Party ) shall have the right to terminate this Agreement forthwith at any time upon giving written notice of termination to the other Party ( Defaulting Party) , upon the occurrence of any of the following events: |
15.2.1 | the Defaulting Party commits a breach of a material obligation set out in this Agreement which is not capable of remedy; | ||
15.2.2 | 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 sixty (60) days of the receipt by it of a notice from the other Party identifying the breach and requiring its remedy; | ||
15.2.3 | the Defaulting Party becomes insolvent or any notice is issued for convening a meeting at which a resolution is to be proposed or any petition is presented (which notice or petition is not withdrawn or discharged within 14 days) for the winding up of the Defaulting Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction), or an order is made or a resolution is passed for the winding up of the Defaulting Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction); | ||
15.2.4 | any notice is given or petition presented or other step is taken in relation to the appointment of an administrator, administrative receiver, receiver or liquidator in respect of a material part of the Defaulting Partys assets or business which is not withdrawn or discharged within 14 days; | ||
15.2.5 | the Defaulting Party makes any composition with its creditors or takes or suffers any similar or analogous action in consequence of debt; | ||
15.2.6 | a mortgagee, chargee or other encumbrancer takes possession of, any part of the Defaulting Partys assets or undertaking; | ||
15.2.7 | the Defaulting Party ceases to continue its business; or | ||
15.2.8 | the Defaulting Party becomes unable to pay its debts as and when they fall due. |
15.3 | Microscience shall have the right to terminate this Agreement upon written notice to the Trust in the event that Microscience decides that it would not be commercially viable to |
26
perform further work on the Project or to commercialise Product further or that there is a technical issue precluding further progress of the Project. | ||
15.4 | Subject to Clause 15.5, if Microscience undergoes a Change of Control, the Trust shall have the right to terminate this Agreement immediately if, in its reasonable opinion, the Change of Control or its consequences would be incompatible with or have an adverse effect, on the Trusts charitable objectives. | |
15.5 | At any time, Microscience may notify the Trust that a transaction is proposed that would result in a Change of Control of Microscience. In the event that Microscience so notifies the Trust, the Trust shall notify Microscience within 30 days of the date of receipt of such notice if it will or will not terminate this Agreement following such Change of Control. In the event that the Trust notifies Microscience that it will not terminate this Agreement following such Change of Control or the Trust fails to respond to Microsciences notice within 30 days of receipt, the Trust shall not be entitled to terminate this Agreement under Clause 15.4 following such Change of Control. |
16.1 | Upon termination of this Agreement for whatever reason, Microscience shall return all funding received from the Trust under this Agreement, which is unspent at the date of termination (after deduction of costs and non-cancellable commitments incurred prior to the date of termination). | |
16.2 | In the event of termination of this Agreement by the Trust under Clause 15.2, or by Microscience under clause 15.3: |
16.2.1 | the Trust shall retain its rights under Clauses 6.1 and 6.2 and, for the avoidance of doubt, Microsciences corresponding obligations under those Sub-Clauses to pay Royalties to the Trust shall continue; | ||
16.2.2 | Microscience shall retain its rights under Clause 6.3 and, for the avoidance of doubt, the Trusts corresponding obligation to pay a Royalty to Microscience under that Sub-Clause shall continue; | ||
16.2.3 | the Trusts rights and Microsciences obligations under Clause 8 shall continue; and | ||
16.2.4 | each Party shall retain its rights under, and be subject to its obligations under, Clause 10. |
16.3 | In the event of termination of this Agreement by Microscience under Clause 15.2: |
16.3.1 | the Trusts rights under Sub-Clauses 6.1 and 6.2 and under Clause 10 shall terminate; and |
27
16.3.2 | the Trusts rights and Microsciences obligations under Clause 8 shall continue. |
16.4 | In the event of termination of this Agreement by the Trust under Clause 15.4: |
16.4.1 | the Trusts rights under Sub-Clauses 6.1 and 6.2, and, for the avoidance of doubt, Microsciences corresponding obligations to pay Royalties under those Sub-Clauses, shall be amended so that Microscience shall pay to the Trust amended Royalties depending on the Instalments paid by the Trust as at the date of termination as follows: |
|
Payment made | Percentage of the Royalty set out in Clauses 6.1 and 6.2 which is payable | ||
|
First Instalment | [**]% | ||
|
Second Instalment | [**]% | ||
|
Third Instalment | [**]% |
16.4.2 | the Trusts rights and Microsciences obligations under Clause 8 shall continue; and | ||
16.4.3 | the Trusts rights under Clause 10 shall terminate. |
16.5 | Termination or expiry of this Agreement for whatever reason shall not affect: (a) rights or obligations which are expressed or intended to continue in force following termination or expiry of this Agreement; or (b) the accrued rights of the Parties arising in any way out of this Agreement as at the date of termination or expiry including in particular, but without limitation, the right to recover damages and interest. Subject to the provisions of Clauses 16.2, 16.3 and 16.4, the provisions of Clauses 4 (Ownership of Project IP), 6 (Royalty), 7 (Books and Records), 8 (Equity Issue), 10 (Access to Product Throughout the World), 13 (Warranties and Indemnity), 14 (Confidentiality), 16 (Consequences of Termination), 22 (Dispute Resolution) and 26 (Third Party Rights) shall remain in full force and effect following termination or expiry of this Agreement. |
17.1 | Neither Party shall be deemed to have waived any of its rights or remedies conferred by this Agreement unless the waiver is made in writing and signed by a duly authorised representative of that Party. In particular, no delay or failure of either Party in exercising or enforcing any of its rights or remedies conferred by this Agreement shall operate as a waiver of those rights or remedies or so as to preclude or impair the exercise or enforcement of those rights or remedies nor shall any partial exercise or enforcement of any right or remedy by either Party preclude or impair any other exercise or enforcement of that right or remedy by that Party. |
28
18.1 | This Agreement and the Application constitute the entire agreement and understanding between the Parties and supersedes all prior oral or written understandings, arrangements, representations or agreements between them relating to the subject matter of this Agreement including, for the avoidance of doubt, the Letter of Intent between the Parties dated 3 rd May 2004 and which became effective on 6 th May 2004. No director, employee or agent of either Party is authorised to make any representation or warranty to another party not contained in this Agreement, and each Party acknowledges that it has not relied on any such oral or written representations or warranties provided always that nothing in this Clause 18.1 shall operate to limit or exclude either Partys liability for fraud or fraudulent misrepresentation. | |
18.2 | No variation, amendments, modification or supplement to this Agreement shall be valid unless made in writing and signed by a duly authorised representative of each Party. |
19.1 | Any notice to be given pursuant to this Agreement shall be in writing and shall be delivered by hand, sent by registered or recorded delivery, airmail post or sent by facsimile confirmed by registered or recorded delivery post to the address or facsimile number of the recipient Party set out below or such other address or facsimile number as a Party may from time to time designate by written notice to the other Party: | |
Address of the Trust: | ||
215 Euston Road, London NW1 2BE | ||
Fax Number: +44 (0)207 611 8857 | ||
All notices to be marked for the attention of the Head of Business Development, cc The Awards Officer, Technology Transfer Division. | ||
Address of Microscience: | ||
540-545 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire, RG41 5TU | ||
Fax Number: +44 (0)118 944 3301 | ||
All notices to be marked for the attention of Rod Richards, Chief Executive Officer. | ||
19.2 | Any notice given pursuant to this Clause 19 shall be deemed to have been received:- |
19.2.1 | in the case of delivery by hand, when delivered; or |
29
19.2.2 | in the case of sending by post: |
19.2.2.1 | where posted in the country of the addressee, on the third Business Day following the day of posting; and | ||
19.2.2.2 | where posted in any other country, on the seventh Business Day following the day of posting; or |
19.2.3 | in the case of facsimile, on acknowledgement by the recipient facsimile receiving equipment on a Business Day if the acknowledgement occurs before 1700 hours local time of the recipient and in any other case on the following Business Day. |
20.1 | Neither Party shall, assign, charge or declare a trust over the benefit and/or burden of this Agreement, except to the extent that the same occurs as a result of the Encumbrances referred to in Schedule 3. |
21.1 | If either Party is unable to carry out any of its obligations under this Agreement due to Force Majeure, this Agreement shall remain in effect but the relevant obligations of the Party unable to carry out its obligations under this Agreement shall be suspended for a period equal to the duration of the circumstances of Force Majeure, provided that: |
21.1.1 | the suspension of performance is of no greater scope than is required by the Force Majeure; | ||
21.1.2 | the Party unable to carry out its obligations under this Agreement gives the other Party prompt notice of the circumstance of Force Majeure, including the nature of the occurrence and its expected duration, and continues to furnish regular reports during the period of Force Majeure; | ||
21.1.3 | the Party unable to carry out its obligations under this Agreement uses all reasonable efforts to remedy its inability to perform and to mitigate the effects of the circumstances of Force Majeure; and | ||
21.1.4 | as soon as practicable after the event which constitutes Force Majeure, the Parties shall discuss how best to continue their operations as far as possible in accordance with this Agreement. |
21.2 | If Force Majeure is continuing at the expiry of six (6) months from its first occurrence, the Parties shall enter into bona fide discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable. |
30
22.1 | Any question, difference or dispute which may arise concerning the construction meaning or effect of this Agreement or concerning the rights and liabilities of the Parties hereunder or any other matter arising out of or in connection with this Agreement shall first be submitted to the Director of the Technology Transfer Division of the Trust and Rod Richards, Chief Executive Officer of Microscience for resolution, who may call on others to advise them as they see fit. | |
22.2 | If the Director of the Technology Transfer Division of the Trust and the Chief Executive Officer of Microscience fail to resolve the dispute within 28 days, such dispute shall be referred to and finally resolved by arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce by one arbitrator appointed in accordance with those Rules. This Agreement shall be governed by the laws of England and Wales, the arbitration shall have its seat in London and the language to be used in the arbitration shall be English. |
23.1 | If the whole or any part of this Agreement is or becomes, or is declared illegal, invalid or unenforceable in any jurisdiction for any reason (including both by reason of the provisions of any legislation and also by reason of any court or Competent Authority which either has jurisdiction over this Agreement or has jurisdiction over any of the Parties): |
23.1.1 | in the case of the illegality, invalidity or unenforceability of the whole of this Agreement, it shall terminate only in relation to the jurisdiction in question; or | ||
23.1.2 | in the case of the illegality, invalidity or unenforceability of part of this Agreement, that part shall be severed from this Agreement in the jurisdiction in question and that illegality, invalidity or unenforceability shall not in any way whatsoever prejudice or affect the remaining parts of this Agreement, which shall continue in full force and effect. |
23.2 | If, in the reasonable opinion of either Party, any severance under this Clause 23 materially affects the commercial basis of this Agreement, the Parties shall discuss, in good faith, ways to eliminate the material effect. |
24.1 | None of the provisions of this Agreement shall be deemed to constitute a partnership between the Parties and neither Party shall have any authority to bind the other in any way except as provided in this Agreement. |
25.1 | Each Party shall bear its own legal costs, legal fees and other expenses incurred in the preparation and execution of this Agreement. |
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25.2 | Each Party shall, at its own cost and expense, carry out, or use all reasonable endeavours to ensure the carrying out of, whatever further actions (including the execution of further documents) the other Party reasonably requires from time to time for the purpose of giving that other Party the full benefit of the provisions of this Agreement both during and after the term of this Agreement. |
26.1 | This Agreement is not intended by the Parties to create rights or benefits in favour of any person not party to this Agreement, or make any rights or benefits enforceable by, or on behalf of, such third parties. For the avoidance of doubt, all laws providing to the contrary in any country including the relevant provisions of the Contracts (Rights of Third Parties) Act 1999 in the United Kingdom are hereby excluded to the fullest extent permitted. |
Signed for and on behalf of
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) | |||||||
THE WELLCOME TRUST
|
) | |||||||
LIMITED as trustee of
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) | |||||||
The Wellcome Trust
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) |
/s/ [Illegible]
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||||||
by its authorised signatory
|
) | Authorised Signatory | ||||||
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||||||||
Signed for and on behalf of
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) | |||||||
THE WELLCOME TRUST
|
) | |||||||
LIMITED as trustee of
|
) | |||||||
The Wellcome Trust
|
) |
/s/ [Illegible]
|
||||||
by its authorised signatory
|
) | Authorised Signatory | ||||||
|
||||||||
Signed for and on behalf of
|
) | |||||||
MICROSCIENCE
|
) |
/s/ [Illegible]
|
||||||
HOLDINGS PLC
|
) | Director |
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Signed for and on behalf of
|
) |
/s/ R. Richards
|
||||||
MICROSCIENCE
|
) | Chief Executive | ||||||
LIMITED
|
) | Director |
33
Project Milestone | Project Milestone Criteria | Project Milestone Date | Instalment | |||
Completion
|
Signature of this agreement | [**] | £[**] | |||
|
||||||
Preparation,
conduct and
completion of Phase
II Adult Study in
Vietnam as set out
in the Application
|
Completion of ID steps 0-15, as described in Schedule 2 under the heading Revised Gantt chart | [**] | £[**] | |||
|
||||||
Decision to
initiate the phase
III surveillance
based on commercial
partnering/NGO
funding
|
Letter to the Trust signed by Microsciences CEO and chairman of the board, or their equivalent positions, setting out the key terms on which funding will be made available for the phase III study | [**] | £[**] |
34
35
Surname:
|
[**] | |
|
||
Forename
|
[**] | |
|
||
Title:
|
[**] | |
|
||
Position:
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[**] | |
|
||
Employing Organization:
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Microscience Ltd |
Q3 Period for which support is sought
(state in months):
|
24 months | |
|
||
Q4 Proposed start date
(dd/mm/yy):
|
01/10/04 | |
|
||
Q5 Does the proposal arise from previous Wellcome Trust funding?
|
o Yes þ No | |
|
||
Q6 Total requested cost
(*deleted as appropriate):
|
£1,410,788 | |
|
||
Cumulative cost to Objective 1:
|
£222,061 | |
|
||
Cumulative cost to Objective 2*:
|
£1,290,576 | |
|
||
Cumulative cost to Objective 3*:
|
£1,410,788 |
36
Principal applicant:
|
[**] | |
|
||
Project title:
|
The safety and immunogenicity of a single dose oral typhoid vaccine in Vietnamese healthy adults and children and identification and preparation of a field site for a Phase III efficacy study |
(I) | In signing the application form where shown below, and in consideration of the receipt of this application by the Wellcome Trust, all applicants (principal applicant, coapplicant, sponsors, technology transfer office/group representatives) UNDERTAKE that the information provided in the application form and otherwise in connection with this application is to the best of their knowledge and belief accurate and complete and that, in relation to any award of grant resulting from the application, they will: |
1. | Take all reasonable actions to ensure that the Wellcome Trusts contribution to the funding of the research is suitably acknowledged. | ||
2. | If research papers (whether based wholly or partly upon the research to be funded by the grant) are published, forward copies to the Wellcome Trust upon publication. | ||
3. | Comply as Wellcome Trust-funded researchers with the Wellcome Trusts principles and policies on relationships between Wellcome Trust-funded researchers and commercial entities as set out in Annex A to the Wellcome Trusts grant conditions. | ||
4. | Meet the requirements of the Wellcome Trust, as set out in the grant conditions, prior to entering into an arrangement with any enterprise that will provide for the exploitation of any results arising from any activity funded under a Wellcome Trust award. | ||
5. | Promptly inform the Wellcome Trust of any material changes during the period of the grant to any of the details provided in this application. |
Signature of applicant
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N/A | Date: |
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|||||
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||||||||
Signature of technology transfer office/group
joint applicant
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Date: |
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Signature of coapplicant
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N/A | Date: |
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|||||
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||||||||
Signature of sponsor (if applicable)
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|
Date: |
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(II) | In signing the application form where shown below, and in consideration of the receipt of this application by the Wellcome Trust, the Head of the Department and Head of Technology Transfer Office/Group UNDERTAKE that the information provided in the application form and otherwise in connection with this application is to the best of his/her knowledge and belief accurate and complete and that, in relation to any award of grant resulting from the application, he/she will: |
1. | Ensure compliance with the Wellcome Trusts principles and policies on relationships between Wellcome Trust-funded researchers and commercial entities as set out in Annex A to the Wellcome Trusts grant conditions. | ||
2. | Meet the requirements of the Wellcome Trust, as set out in the grant conditions, prior to entering into an arrangement with any enterprise that will provide for the exploitation of any results arising from any activity funded under a Wellcome Trust award. | ||
3. | Promptly inform the Wellcome Trust of any material changes during the period of the grant to any of the details provided in this application. |
Signature of Head of Department N/A
|
Date: |
|
||||
|
||||||
Signature of Head of Technology Transfer Office/Group N/A
|
Date: |
|
(III) | In signing the application form where shown below, and in consideration of the receipt of this application by the Wellcome Trust, the institution UNDERTAKES that the information provided in the application form and otherwise in connection with this application is to the best of its knowledge and belief accurate and complete, and that it will: |
1. | Ensure compliance with the Wellcome Trusts principles and policies on relationships between Wellcome Trust-funded researchers and commercial entities as set out in Annex A to the Wellcome Trusts grant conditions. | ||
2. | Meet the requirements of the Wellcome Trust, as set out in the grant conditions, prior to entering into an arrangement with any enterprise that will provide for the exploitation of any results arising from any activity funded under a Wellcome Trust award. | ||
3. | Obtain from all individuals, subsequently funded as a result of the application, the equivalent undertakings as required from the applicants ab initio (i.e. before funding takes place). | ||
4. | Apply with full rigour all relevant arrangements for the protection of any patentable intellectual property rights arising from any research funded as a result of this application, as detailed in the grant conditions. However, if the institution decides not to proceed with the protection of any patentable intellectual property rights, it will co-operate fully (and ensure that its employees, students, contractors, and representatives co-operate) with Technology Transfer at the Wellcome Trust such that the Wellcome Trust will have an unreserved and unrestricted right, but not a duty, to seek patent protection. | ||
5. | Take full responsibility for the management, monitoring and control (including the requirements of all regulatory authorities governing the use of radioactive isotopes, animals, pathogenic organisms, genetically manipulated organisms (GMOs), toxic and hazardous substances, and research on human subjects and human embryos) of all the research work funded as the result of the application and all those staff (permanent, temporary and students) employed in or involved in any research funded as a result of the application. | ||
6. | Ensure that all permanent and temporary staff and students employed in or involved in the research receive training appropriate to their duties, in accordance with the regulations set down under the COSHH, ACDP and ACGM guidelines, the Health and Safety at Work regulations, and any other statutory or regulatory requirements as may apply from time to time. | ||
7. | Promptly inform the Wellcome Trust of any material changes during the period of the grant to any of the details provided in this application. |
37
Signature of Secretary of Institution/Finance Officer:
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Date: | |||||
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Institution: |
Position:
|
|
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38
Name:
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[**] | Title | [**] | |||
Post
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[**] | |||||
Address: | 540-545 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire RG41 5TU | |||||
Tel:
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[**] | Fax: | ||||
E-mail:
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[**] |
Name:
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N/A | Title | ||||
Post
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Address:
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Tel:
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Fax: | |||||
E-mail:
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Name:
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N/A | Title | ||||
Post
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Address:
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Tel:
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Fax: | |||||
E-mail:
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Name:
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[**] | Title | [**] | |||
Post
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[**] | |||||
Address:
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[**] | |||||
Tel:
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[**] | Fax: | ||||
E-mail:
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[**] |
39
Name:
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[**] | Title | [**] | |||
Post
|
[**] | |||||
Address:
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[**] | |||||
Tel:
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[**] | Fax: | [**] | |||
E-mail:
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[**] |
Name:
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[**] | Title | [**] | |||
Post
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[**] | |||||
Address:
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[**] | |||||
Tel:
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[**] | Fax: | [**] | |||
E-mail:
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40
Signed:
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Date: | |||||||
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Name:
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Position: |
41
42
Wellcome Trust
website o |
Other Wellcome Trust
contact o |
University or technology transfer
office/group þ |
Press o Other (please specify) |
43
(a) | Is this the principal applicants first application to the Wellcome Trust? | |
If no, please give details of previous approaches over the last five years. | ||
Indicate with an (*) those awards (if any) which have contributed to the background of this proposal. |
(b) | Is this application a resubmission of an application previously considered by the o Yes þ No |
|
Wellcome Trust? | |||
|
||||
|
If yes, when and where was it considered? | N/A | ||
|
||||
|
Please give the Wellcome Trusts reference number: | N/A | ||
|
||||
In a covering letter briefly state how this application differs from the original. |
44
State name of awarding body, title of project, amount awarded, dates of support and proportion of time spent on each project. | ||
(a) | Current sources of funding | |
Indicate with an (*) those awards (if any) which have contributed to the background of this proposal. |
(b) | Any other source of funding that has directly contributed to the background of this proposal. |
45
Name of applicant: | [**] |
Q11 | Patent Information | |||||
|
||||||
(Please continue on an additional sheet if necessary.) | ||||||
|
||||||
Have any patent(s) or patent application(s) been filed by the applicant(s) þ Yes o No | ||||||
which relate to this proposal? | ||||||
|
||||||
If yes, please provide details: | ||||||
|
||||||
|
1) | Application number or publication number: | W096/17951 | |||
|
||||||
|
Priority date: | 11 December 1995 | ||||
|
||||||
|
Inventors: | D W Holden, J E Shea, M Hensel | ||||
|
||||||
|
Applicant: | RPMS (now co-owned by Microscience Ltd) | ||||
|
||||||
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Funding source: | N/A | ||||
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||||||
|
2) | Application number or publication number: | W000/68261 | |||
|
||||||
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Priority date: | 10 May 1999 | ||||
|
||||||
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Inventors: | G Dougan, J D Santengelo, D W Holden, J E Shea, Z Hindle | ||||
|
||||||
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Applicant: | Microscience Ltd | ||||
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||||||
|
Funding source: | N/A |
46
Please refer to the guidelines notes before completing this section. | ||
(a) | Please detail the key objectives of the proposal, relating these to the proposed project Objectives. |
| Identification of site | ||
| Clinical protocol development | ||
| Regulatory approval from Vietnamese and US authorities | ||
| Assay transfer | ||
| Manufacture and release of clinical material | ||
| Screening and recruitment of subjects |
| Dosing | ||
| Monitoring of study (safety and GCP) | ||
| Evaluation of safety | ||
| Completion of immunoassays | ||
| Management and validation of data |
| Identification of site | ||
| Establishment of infrastructure | ||
| Perform Census | ||
| Establishment and provide training in diagnostic tools | ||
| Disease surveillance |
47
Name of applicant: | [**] |
(b) | Describe how this proposal will ultimately lead to healthcare benefit |
48
(c) | Give relevant technical background information (maximum 1 1 / 2 pages) |
49
50
51
Name of applicant: | [**] |
(d) | Describe the workplan (this should not be more than four pages, excluding the project timeline) |
| Identify up to three scientific objectives clearly within the workplan. | ||
| Present the project timescale visually as a Gantt chart or other project timeline profile as a one-page appendix to this application form. |
| Identification of site. Responsibility of the clinical investigators [**]. It is important that phase II safety and immunogenicity data is generated in subjects representative of the target population for the field study. It is therefore intended that a number of the phase II studies will be performed in the endemic region in the Mekong Delta. However, at least the first study, in adult volunteers, will be undertaken under well-controlled conditions at the Oxford University Clinical Research Unit at the Hospital of Tropical Diseases in Ho Chi Minh City. This will ensure that technology is transferred, staff are trained and the regulatory approval process is undertaken as efficiently as possible, prior to moving the programme into the endemic region. Once vaccine safety has been adequately demonstrated in this study approval will be sought to perform subsequent studies in the endemic region. | ||
| Clinical protocol development. Individual protocols will be written for each of the studies. The protocols will be owned by Microscience but developed jointly by Microscience and the clinical investigators ([**]). | ||
| Regulatory approval. Microscience will be responsible for obtaining regulatory approval for the clinical studies and for field site development. Approval will be sought from both the Vietnamese and US regulatory agencies, as it is intended that the clinical studies will be performed under the US IND that is held for this product by Microscience. | ||
| Local ethics approval. The clinical investigators ([**]) will be responsible for obtaining ethics approval from the local Independent Review Board (IRB). Microscience and the clinical investigators ([**]) will be responsible for preparing the documentation required for submission. | ||
| Assay transfer. Assay transfer from Microscience to the Hospital for Tropical Diseases is the responsibility of both parties and is expected to take 1 month. The immunoassays being used for these studies have been standardised at Microscience. Assay transfer will ensure that assay performance is comparable at the Hospital for Tropical Diseases, at Microscience and in previous clinical studies. The process involves performing the assays multiple times using reference samples. Transfer will be considered successful once an analyst has performed a pre-defined number of assays that have each met the validity criteria. | ||
| Manufacture and release of clinical material. Responsibility of Microscience. |
52
Name of applicant: | [**] |
(d) | Workplan (continued) |
| Identification of site. [**] will have joint responsibility. |
| Establishment of infrastucture. [**] will have joint responsibility. | ||
| Perform Census. [**]will have joint responsibility. |
| To assign a unique study identification number of each individual resident in the household | ||
| To obtain base-line data on socio-economic status, health seeking behaviour, prior typhoid vaccine usage and potential typhoid risk factors | ||
| To provide the household members with information on the project |
| Establish and provide training in diagnostic tools. [**] will have joint responsibility. | ||
| Disease surveillance, [**] will have joint responsibility. |
53
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54
| Dosing. Responsibility of the clinical investigators ([**]). |
| Evaluation of safety. Responsibility for the clinical investigators ([**]). |
| reporting adverse events during the study, particularly a fever of more than [**] ° C, attributable to the study medication. |
| withdrawn from the study due to adverse events, including bacteraemia attributed to study medication | ||
| demonstrating bacteraemia, attributable to the study medication | ||
| demonstrating persistent faecal shedding ([**]) of S. typhi (Ty2 aroC¯ ssaV¯ ) ZH9, in stools | ||
| with changes in laboratory parameters from Day 0 to post treatment which are considered clinically significant | ||
| Completion of immunoassays. Responsibility of the clinical investigators ([**]). |
| Monitoring of study (safety and GCP). Responsibility of Microscience. | ||
| Management and validation of data. Responsibility of Microscience. |
55
|
Dosing. Responsibility of the clinical investigators ([**]).
Group 10-18 years it is anticipated that data from the adult study will support the use of the same dose level, [**] dose, and formulation of vaccine as was administered to adults. |
||
Group 5-10 years evaluation of safety data from the study in 10-18 year olds will determine whether dose escalation will be required for this study. Dose escalation will require an additional group of subjects who will receive a lower vaccine dose level (likely to be [**]). | |||
|
Evaluation of safety. Responsibility of the clinical investigators ([**]).
As for adult study. |
||
| Completion of Immunoassays. Responsibility of the clinical investigators ([**]). | ||
The assays used will be the same as for the adult study. | |||
| Monitoring of study (safety and GCP). Responsibility of Microscience. | ||
| Management and validation of data. Responsibility of Microscience. |
56
Name of applicant: | [**] | ||||
(a) | Intellectual property and freedom to operate (suggested 1 1 / 2 pages) | ||
(b) | Competitive position (suggested 1 page) | ||
(c) | Managing, monitoring and reporting the project (suggested 1 / 2 page) | ||
(d) | Commercialization strategy (suggested 1 1 / 2 pages) |
57
58
Name of applicant: | [**] | ||||
59
60
[**] | |||||
61
Name of applicant: | [**] | ||||
Q14
|
References | |||||||
|
Please give citations in full including titles of papers and all authors. |
1. | Chatfield, S.N., Roberts, M., Li, J-L, Starns, A. and Dougan, G. 1994. The use of live attenuated Salmonella for oral vaccination. In: Recombinant Vaccines in Vaccine Development: Dev. Biol. Stand. Basel, Karger 82 , 35-42. | ||
2. | Tacket, C.O, Sztein, M.B., Losonsky, G.A., Wasserman, S.S., Nataro, J.P., Edelman R., Pickard, D., Dougan, G., Chatfield, S.N. and Levine, M.M. 1997. Safety of live oral Salmonella typhi vaccine strains with deletions in htr A and aro C aro D and immune response in humans. Infect. Immun. 65 , (2) p.452-456. | ||
3. | Shea, J.E, Buezon, C.R, Gleeson C, Mundy R, Holden, D.W. Influence of the Salmonella typhimurium Pathogencity isaland 2 type III secretion system on bacterial growth in the mouse. Infect. Immun. 1999, 67(1): 213-219. | ||
4. | Hindle Z, Chatfield SN, Phillimore J, Bentley M, Johnson J, Cosgrove CA, Ghaem-Maghami M, Sexton A, Khan M, Brennan FR, Everest P, Wu T, Pickard D, Holden DW, Dougan G, Griffin GE, House D, Santangelo JD, Khan SA, Shea JE, Feldman RG, Lewis DJ Characterization of Salmonella enterica derivatives harboring defined aro C and Salmonella pathogenicity island 2 type III secretion system ( ssaV ) mutations by immunization of healthy volunteers. Infect. Immun. 2002 Jul:70(7):3457-67.. | ||
5. | Shahid A Khan, Richard Stratford, Tao Wu, Nicola McKelvie, Trevor Bellaby, Zoe Hindle, Katharine A Sinha, Shayne Eltze, Piero Mastronel, Derek Pickard, Gordon Dougan, Steven N Chatfield, Frank R Brennan Salmonella typhi and S. typhimurium derivatives harbouring deletions in aromatic biosynthesis and Salmonella pathogenicity island-2 (SPI-2) genes as vaccines and vectors Vaccine 21 (2003) 538-548 | ||
6. | Kantele, A. Antibody secreting cells in the evaluation of the immunogencicty of an oral vaccine. Vaccine. 1990 (8) 321-326 | ||
7. | Ferreccio. C, Levine. M.M, Rodriguez, H, Contreras. R, Chilean Typhoid Committee. | ||
J. Infect. Dis 1989 (159) 4 766-769 | |||
8. | Feng-Ying C. Lin, Vo Anh Ho, Phan Van Bay, Hguyen Thi Thanh Thuy, Dolores Brlyla, Tran Cong Thanh, Ha Ba Khiem, Dang Duc Trach and John B. Robbins. The epidemiology of typhoid fever in the Dong Tap Province, Mekong Delta Region of Vietnam. J. Trop. Med. Hyg. 2000 62 (5), 2000 644-648. |
62
63
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£ Yes | R No |
64
|
Do your proposals involve the use of animals or animal tissue? | £ Yes | R No | |||
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(a)If yes, do your proposals include procedures to be carried out on animals in the UK which require a Home Office Licence? | £ Yes | R No | ||||
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If yes, has the Home Secretary granted a Project Licence under the terms and the Animals (Scientific Procedures) Act 1986, authorising the proposed experiments? | £ Yes | £ No | |||
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If yes, state the name and address of the licensee, the Project Licence reference number, date of issue and end date. |
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Do you, or any other researchers associated with the project, hold a Personal Licence under the Animals (Scientific Procedures) Act 1986, permitting the procedures required for the research to be carried out? | £ Yes | £ No | |||
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If yes, state Personal Licence Reference Number and name of licence holder. |
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If no, has an application been made for such a licence? | £ Yes | £ No | |||
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Please give a brief explanation, including the date when an application will be made. |
(b) Do your proposals involve the use of animals or animal tissue outside the UK? | £ Yes | R No |
65
Name of applicant: | [**] | ||||
Special | ||||||||||||||||||||||||||||||||
requirements | Total | |||||||||||||||||||||||||||||||
(single bunch, | number | Number of days per annum | ||||||||||||||||||||||||||||||
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(c)
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Will the proposed research require access to a neutron source? | £ Yes | R No | |||||
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If yes, complete Q18(a) and (b) above indicating that it is a neutron source that is required | . |
66
Name of
applicant:
|
[**]
|
Q19
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Related applications |
(b)
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Has this or a related application already been submitted elsewhere? |
N/A
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If yes, to which organization? |
N/A
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If a decision has been given, what was the result? | |||
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If a decision has not yet been given, when is a decision expected? (dd/mm/yy) |
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(c) | What proportion of working time do the principal applicant and coapplicant(s) spend on research? (%) | |
What proportion of this time will the principal applicant and coapplicant(s) spend on this project? (%) |
Name
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% Working time
on research |
Project time as
% of research time |
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(
d)
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Will the research project be undertaken in a Wellcome Trust Clinical Research Facility? | þ Yes o No |
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If yes, please
specify: |
Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh,
Vietnam |
(e)
|
Will the research project be undertaken in a Wellcome Trust Centre? | o Yes þ No |
67
(a)
|
Do any of the scientific applicants hold any directorships, equity holdings, Scientific Advisory Board memberships or consultancy arrangements in companies or other organizations that may have an interest in the results of the proposed research? | R Yes | £ No | |||
|
||||||
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If yes, please refer to guidance notes, give brief details and provide copies of relevant agreements. |
(b)
|
Is the proposed research in whole or in part, subject to any agreements with | Yes R | £ No | |||
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commercial, academic or other organizations? | |||||
|
If yes, give details |
68
69
Q21 | Curriculum vitae of principal applicant | |||||||
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This page should be duplicated if there is more than one applicant/coapplicant/sponsor. | ||||||||
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71
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73
Q23 | Curriculum vitae of named research assistant(s) | |
This page may be duplicated if more than one research assistant is required. |
(a)
|
Surname: |
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Date of |
|
||||
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||||||||
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Forename |
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Nationality: |
|
||||
|
||||||||
(b) | Degrees, diplomas etc. (subject, class, university and dates): | |||||||
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(c) | Current post (if not currently in employment, please give details of most recent post): | ||||
|
Position and |
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Institution: |
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Funding |
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Termination date of |
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Current basic salary and incremental |
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||
Basic salary must be shown separately from any salary enhancements or other allowance |
|
If currently funded by a Wellcome Trust grant, please give grant reference number: |
|
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|
||||
(d)
|
Previous posts (with dates): |
|
|
74
(e) | Recent publications: (List no more than five publications. Please give citation in full, including title of paper and all authors) |
(f) | Please confirm that you have obtained the research assistants consent to disclose the information provided above in accordance with the principles set out in the Wellcome Trust Data Protection statement which appears on this form. £ |
75
Q24
|
Reasons for support requested | |
|
||
|
Please refer to guidance notes before completing this section. | |
|
||
|
On this page justify (a) the scientific staff requested |
76
Q24 | Reasons for support requested (continued) |
77
Q24 | Reasons for support requested (continued) |
78
Q24 | Reasons for support requested (continued) | |
On this page justify (e) Use of animals. Address the following: |
(i) | Why is animal use necessary? Are there any other possible approaches? | ||
(ii) | Is the species to be used the most appropriate? This is especially important when an animal is being used as a model for a human physiological or pathological condition. Also consider whether the model is an appropriate pharmaceutical industry standard for the investigation. | ||
(iii) | Is the number of animals required to achieve significance in the experimental design appropriate? What are the factors that might affect this? Outline the sample size calculations that have been used to estimate the number of animals required in the proposed experimental design. |
Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | ||||||||||||||||
(b) Purchase
|
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Source of supply and biological quality
|
79
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|
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(c) Maintenance
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(d) Experimental procedures
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80
Name:
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||||||||||||||
Level Required (specify one, two, three or four): | ||||||||||||||
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||||||||||||||
Period of funding sought: | From: | to: | ||||||||||||
Full-time o Part-time o If part-time, state percentage of full time: | % | |||||||||||||
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Name:
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||||||||||||||
Level Required (specify one, two, three or four): | ||||||||||||||
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Period of funding sought: | From: | to: | ||||||||||||
Full-time o Part-time o If part-time, state percentage of full time: | % | |||||||||||||
|
Name:
|
Grade: | Incremental date: | ||||||||
Start date:
|
End date: | Time spent on grant (%): | ||||||||
Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total | |||||||||||||||||||
Commencing salary:
|
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London Allowance:
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Sub total
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Name:
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Grade: | Incremental date: | ||||||||
Start date:
|
End date: | Time spent on grant (%): | ||||||||
Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total | |||||||||||||||||||
Commencing salary:
|
||||||||||||||||||||||||
London Allowance:
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Name: | Level (specify one, two, three or four): | |||||||||
Period of funding sought: | Start date: | End date: | ||||||||
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Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total | |||||||||||||||||||
Commencing salary:
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London Allowance:
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Employers
contributions:
% |
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Sub total
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81
Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total | |||||||||||||||||||
Materials and
consumables
(Please give brief description) |
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Subtotal
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Animals
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Total purchase price:
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p.a.
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Total maintenance cost:
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Total procedure cost:
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Subtotal
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Miscellaneous
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Subtotal
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Total
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82
(e) | Equipment and equipment maintenance | |
This page may be duplicated if necessary. Please include costs for access charges and for equipment maintenance for equipment not being requested elsewhere in this grant application. | ||
Give contact details for the Universitys Director of Procurement/Head of Purchasing (or equivalent) |
Name:
|
Tel: | |||||
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Address:
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Fax: | |||||
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E-mail: | |||||
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Preferred | ||||||||||||||||||||||||
Type of equipment | manufacturer | Preferred supplier | Number | Cost per | ||||||||||||||||||||
(see notes) | Equipment specification | (if known) | (if known) | of items | Item | Total cost | ||||||||||||||||||
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Total: |
Signature:
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Name (in
full): |
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(University Head of Procurement) |
83
Type of equipment/facility for | Original source/duration of funding | |||||||||||||||
which access, maintenance or | (provide Trust grant reference | Estimated usage time for applicant and | ||||||||||||||
upgrade is requested | number if applicable) | Date of award | Date of purchase | other users | ||||||||||||
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84
Q27 | SUBJECT CLASSIFICATION | |
(A) |
SYSTEMS AND PROCESSES
Choose one primary classifier (compulsory) and up to three secondary classifiers |
(B) |
DISEASE
Choose one primary classifier (compulsory) and up to three secondary classifiers |
Secondary:
|
Typhoid |
(C) |
DISCIPLINE
Choose one primary classifier (compulsory) and up to three secondary classifiers (optional). |
Secondary:
|
Immunology | |
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||
|
Microbiology |
(f) | Check relevant subject classification box | |||||
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Basic | o | ||||
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Clinical | þ | ||||
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Tropical | o | ||||
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Veterinary | o | ||||
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Translation | o |
85
86
Visit | Screen | 1 | 2 | 3 | 4 | 5 | 6 | |||||||||||||||||||||
Day | -28 to -2 | 0 | 1 | 7 | 10 | 14 | 28 | |||||||||||||||||||||
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87
| reporting adverse events during the study, particularity a fever of more than [**]° C, attributable to the study medication. |
| withdrawn from the study due to adverse events, including bacteraemia attributed to study medication. | ||
| demonstrating bacteraemia, attributable to the study medication | ||
| demonstrating persistent faecal shedding ([**]) of S. typhi (Ty2 aroC ¯ ssaV ¯) ZH9, in stools | ||
| with changes in laboratory parameters from Day 0 to post treatment which are considered clinically significant |
88
| Identification of site: Responsibility of the clinical investigators [**]. It is important that phase II safety and immunogenicity data is generated in subjects representative of the target population for the field study. It is therefore intended that a number of the phase II studies will be performed in the endemic region in the Mekong Delta. However, at least the first study, in adult volunteers, will be undertaken under well-controlled conditions at the Oxford University Clinical Research Unit at the Hospital of Tropical Diseases in Ho Chi Minh City. This will ensure that technology is transferred, staff are trained and the regulatory approval process is undertaken as efficiently as possible, prior to moving the programme into the endemic region. Once vaccine safety has been adequately demonstrated in this study approval will be sought to perform subsequent studies in the endemic region. | ||
| Clinical protocol development: The protocol will be owned by Microscience but developed jointly by Microscience and the clinical investigators ([**]). | ||
| Regulatory approval: Microscience will be responsible for obtaining regulatory approval for the clinical study. Approval will be sought from both the Vietnamese and US regulatory agencies, as it is intended that the clinical programme will be performed under the existing US IND that is held for this product by Microscience. | ||
| Local ethics approval: The clinical investigators ([**]) will be responsible for obtaining ethics approval from the local Independent Review Board (IRB). Microscience and the clinical investigators ([**]) will be responsible for preparing the documentation required for submission. | ||
| Assay transfer: Assay transfer from Microscience to the Hospital for Tropical Diseases is the responsibility of both parties and is expected to take 1 month. The immunoassays being used for these studies have been standardised at Microscience. Assay transfer will ensure that assay performance is comparable at the Hospital for Tropical Diseases, at Microscience and in previous clinical studies. The process involves performing the assays multiple times using reference samples. Transfer will be considered successful once an analyst has performed a pre-defined number of assays that have each met the validity criteria. | ||
| Manufacture and release of clinical material: Responsibility of Microscience. The clinical material will be vaccine, placebo and [**], manufactured to cGMP. [**] |
89
| Screening and recruitment of subjects: Responsibility of the clinical investigators ([**]). To begin once regulatory and ethics approval have been obtained. For each subject screening has to occur within 28 days of dosing. All efforts will be put in place to obtain written consent that is informed and given voluntarily as described in Appendix C. | ||
| Dosing: Responsibility of the clinical investigators ([**]) | ||
| Evaluation of safety: Responsibility of the clinical investigators ([**]). | ||
| Completion of immunoassays: Responsibility of the clinical investigators ([**]). | ||
| Monitoring of study (safety and GCP): Responsibility of Microscience. | ||
| Management and validation of data: Responsibility of Microscience. | ||
90
| New batches of vaccine and placebo will be manufactured in 2005 for the studies in children. Following packaging and labelling, review of the manufacturing batch records and receipt of regulatory and ethics approval, the material will be released by Microscience for use in the clinic. | ||
| Dosing. Responsibility of the clinical investigators ([**]). Group 1018 years it is anticipated that data from the adult study will support the use of the same dose level, [**] nominal dose, and formulation of vaccine as was administered to adults. | ||
Group 5-10 years evaluation of safety data from the study in 10-18 year olds will determine whether dose escalation will be required for this study. Dose escalation will require and additional group of subjects who will receive a lower vaccine dose level (likely to be [**]). | |||
| Evaluation of safety. Responsibility of the clinical investigators ([**]). As for adult study. | ||
| Completion of immunoassays. Responsibility of the clinical investigators ([**]). The assays used will be the same as for the adult study. | ||
| Monitoring of study (safety and GCP). Responsibility of Microscience. | ||
| Management and validation of data. Responsibility of Microscience. |
91
| Establishment of infrastructure. [**] will have joint responsibility. | ||
| Perform Census. [**] will have joint responsibility. |
A census will be performed in the study area. [**]. Each of these households and each individual residing in the household is given a unique identification number (ID#), which is used for all interactions that occur as part of the study. ID numbers will be allocated based on the serial number of the census form, and the sequential order within each household. The aims of the census will be as follows: |
| To assign a unique study number to each household | ||
| To assign a unique study identification number to each individual resident in the household | ||
| To obtain base-line data on socio-economic status, health seeking behaviour, prior typhoid vaccine usage and potential typhoid risk factors | ||
| To provide the household members with information on the project |
| Establish and provide training in diagnostic tools. [**] will have joint responsibility. |
92
93
94
1. |
Identification of Genes
Patent application WO 96/17951 |
|
2. |
Attenuated Microorganisms for the Treatment of Infection
Patent Application WO 00/68261 |
1. | A loan note facility dated 6 th October 2004 provided by the existing investment syndicate to Microscience to fund the working capital requirements of the group pending agreement of a series C financing round; and | |
2. | Fixed and floating charges over all Microscience assets, including the rights and benefits of this Agreement, in favour of the holders of loan notes to secure loan notes provided under a loan note agreement dated 6 th October 2004. |
95
96
97
A
|
Microscience Press Release |
98
Microscience
|
+ 44 (0)118 944 3300 | |
|
||
Rod Richards, Chief Executive Officer
|
||
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||
Weber Shandwick Square Mile
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+ 44 (0)20 7067 0700 |
99
100
B | Trust Statement |
101
1. | THE WELLCOME TRUST LIMITED a company incorporated in England and Wales under registration number 2711000 whose registered office is at 215 Euston Road, London NW1 2BE, as trustee of the Wellcome Trust, a charity registered in England under number 210813 (the Trust ); | |
2. | MICROSCIENCE HOLDINGS PLC a company incorporated in England and Wales under registration number 5106930 whose registered office is at 545 Eskdale Road, Winnersh, Wokingham, Berkshire RG41 5TU ( MS Holdings ); and | |
3. | MICROSCIENCE LIMITED a company incorporated in England and Wales under registration number 3270465 whose registered office is at 545 Eskdale Road, Winnersh, Wokingham, Berkshire RG41 5TU ( MS Limited ); | |
together the Parties . |
A. | By an agreement (the Agreement ) dated 18 March 2005 between the Parties, the Trust agreed, inter alia, to make a Programme Related Investment (as defined in the Agreement) by way of subscribing for ordinary shares in MS Holdings and providing further funding to MS Holdings to undertake research and development of MS Holdings single-dose, oral type typhoid vaccine. | |
B. | MS Holdings has agreed to sell its shareholding in MS Limited to a subsidiary of Emergent Biosolutions, Inc. which will mean that MS Holdings is unable to perform its obligations under the Agreement. | |
C. | In contemplation of the completion of the transaction set out in recital B, MS Holdings has agreed to assign to MS Limited the benefit of the Agreement, subject to the consent of such assignment by the Trust. | |
D. | Following the completion of the sale of the shares in MS Limited by MS Holdings ( Completion ), MS Limited wishes to perform the Agreement and (subject to this Deed) MS Limited and the Trust have agreed to release MS Holdings from its obligations under the Agreement on and with effect from Completion and the Parties have agreed that with effect from such date the rights and obligations of MS Holdings in relation to the Agreement shall be novated to and assumed by MS Limited in its own right and on its own behalf in substitution for MS Holdings. |
1. | Assignment by MS Holdings | |
1.1 | MS Holdings assigns to MS Limited with full title guarantee the rights, claims, liberties and full benefit of the Agreement to hold the same unto MS Limited absolutely. | |
1.2 | At the request and cost of MS Limited, MS Holdings shall, at all times after the date of this deed, do all acts and execute all documents as may be reasonably necessary or desirable to secure the vesting in MS Limited of the benefit of the Agreement. | |
1.3 | The Trust hereby consents to the assignment of the Agreement pursuant to this Clause, and the restriction on assignment contained in clause 20.1 of the Agreement is hereby waived in respect of such assignment. |
2. | Undertaking by MS Limited | |
Subject to Clause 6, on and with effect from the date of Completion, MS Limited undertakes with the Trust and MS Holdings to perform and accept all obligations and liabilities arising under the Agreement on and with effect from Completion and to be bound by the terms of the Agreement in every way as if MS Limited were named therein in place of MS Holdings. | ||
3. | Release of MS Holdings | |
Subject to Clause 6, on and with effect from the date of Completion, the Trust releases and discharges MS Holdings from all obligations, claims, liabilities and demands whatever arising under the Agreement on or after the date of Completion and accepts the liability of MS Limited under the Agreement in place of the liability of MS Holdings and agrees to be bound by the terms of the Agreement in every way as if MS Limited was named therein in place of MS Holdings. | ||
4. | Intellectual Property Assignment | |
On and with effect from the date of Completion, MS Holdings hereby assigns with full title guarantee all its rights title and interest in the Project Intellectual Property (as defined in the Agreement) and the Background Intellectual Property (as defined in the Agreement) to MS Limited. | ||
5. | Consequential Amendments | |
Subject to Clause 6, on and with effect from the date of Completion, as between the Trust and MS Limited and to the extent relevant for the purposes of carrying out their obligations under the Agreement all references in the Agreement to MS Holdings shall with respect to the rights and obligations arising on or after the date of this novation be deemed to be references to MS Limited and all other necessary amendments consequent upon the change of identity of the parties shall be deemed to be made in the Agreement. | ||
6. | Variation of clause 8 of the Agreement | |
6.1 | The amount of £[**] of the First Instalment paid to MS Holdings by the Trust shall be treated as a subscription by the Trust for an additional [**] A ordinary shares in the capital of MS Holdings and accordingly the figure in clause 8.1 of the Agreement of [**] shall be and is hereby deleted and replaced with the figure of [**] and clause 8.2 of the Agreement shall be deleted and left blank. | |
6.2 | MS Holdings will immediately issue and allot to the Trust fully paid an additional [**] A ordinary shares. | |
7. | Extent of Novation | |
Nothing in this deed: |
(a) | shall impose on MS Limited any obligations other than those contained in the Agreement or any liability to issue equity to the Trust; or | ||
(b) | relieve MS Holdings from any obligations other than those contained in the Agreement. |
8. | Governing law and jurisdiction | |
8.1 | This deed and any disputes or claims arising out or in connection with its subject matter are governed by and construed in accordance with the laws of England. | |
8.2 | The parties irrevocably agree that the courts of England have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this deed. |
EXECUTED AS A DEED by
THE WELLCOME
TRUST LIMITED as trustee of the WELLCOME TRUST acting by |
)
) ) |
/s/ [Illegible] | /s/ [Illegible] | |||||
|
||||||||
|
Authorised
Signatory |
Authorised
Signatory |
||||||
|
||||||||
EXECUTED AS A DEED
by
MICROSCIENCE
HOLDINGS PLC acting by: |
)
) |
/s/ [Illegible] | /s/ [Illegible] | |||||
|
||||||||
|
Director/Secretary | Director | ||||||
|
||||||||
EXECUTED AS A DEED
by
MICROSCIENCE
LIMITED |
) | |||||||
acting by:
|
) | /s/ [Illegible] | /s/ [Illegible] | |||||
|
||||||||
|
Director/Secretary | Director |
1. | Position | |
1.1 | President of Emergent Europe Limited reporting to the Chief Executive Officer of Emergent BioSolutions Inc., a Delaware corporation with its offices located at 300 Professional Drive, Gaithersburg, MD, USA, or to such other person as the Chief Executive Officer of Emergent BioSolutions may from time to time appoint. | |
2. | Preconditions | |
2.1 | Your employment with the Company is conditional on (a) your producing at least two references to the Company which the Company considers satisfactory, which has been satisfied, and (b) such documentation as the Company may require to establish your right to work lawfully in the United Kingdom and (c) the company receiving a medical report from its Occupational Health Advisers which the Company considers satisfactory. (Please complete the enclosed pre-employment health questionnaire and return to the Occupational Health Department in the pre-paid envelope provided, your answers will be treated as strictly confidential and you may be required to attend a health interview/ examination) Should you fail to produce to the Company the required documentation, or should the medical report not prove satisfactory to the Company, then any offer of employment by the Company may be withdrawn and if already accepted, the Company may terminate your employment without notice or a payment in lieu of notice (or on statutory minimum notice if applicable). | |
3. | Responsibilities | |
3.1 | Your normal responsibilities are set out in your written job description but you may be required to perform other reasonable tasks from time to time. (The job description does not have contractual force, but is intended as a guide to your main duties). You may be required to carry out your duties for the benefit of associated companies of the Company, without payment of additional remuneration. | |
3.2 | You are required to devote the whole of your time, attention and ability to the Company (or any associated companies for whom you are required to work) and to use your best endeavours to promote, develop and expand the business of the Company and its interests generally. You agree not to have any outside business or other interests which conflict or may conflict with the interests of the Company or any associated Company or which may otherwise interfere with or impede your ability to carry out your responsibilities for the Company, without specific written approval of the Company given in advance. |
1
3.3 | You must not act in any way that may be harmful to the Companys interests and/or damages the reputation of the Company. | |
3.4 | You are expected to comply with the Companys policies and procedures (as issued and/or amended from time to time), even though these do not form part of your contract of employment. The policies and procedures are available electronically on the Companys systems or from the Administration Office. Failure to comply, may lead to disciplinary action. In the event of a conflict between the terms of this contract and any Company policy, the terms of this contract will apply | |
3.5 | You shall not at any time, (including during any period spent on garden leave), make any disparaging, untrue or misleading oral or written statements concerning the business and affairs of the Company or any associated company. | |
4. | Duration | |
4.1 | Your employment with the Company commenced as of June 24, 2005 in accordance with the letter agreement between you and Emergent BioSolutions dated September 16, 2005. Your prior period of employment with Emergent BioSolutions counts towards your period of continuous employment. | |
4.2 | Subject to clause 19 below, the period of notice required by either party to terminate your employment is six (6) months, or the statutory minimum whichever is the greater. Notice under this sub-clause must be given in writing | |
4.3 | Subject to any contrary provision of law, your employment will end automatically without the need for notice of termination to be served, at the end of the month in which you reach the age of 65, which is the Companys normal retirement age. | |
5. | Salary | |
5.1 | Your gross salary (Salary) will be One Hundred Forty Nine Thousand Nine Hundred Fourteen Pounds (£149,914) per annum payable by equal monthly instalments directly to your bank or building society account. It is our normal practice to pay Salary on approximately the 24th day of each calendar month. Salary through December 31, 2005 has been paid through Emergent BioSolutions Inc. in U.S. dollars. The above payment schedule for Salary will commence on January 1, 2006. Salary will be accrued on a daily basis. The Companys policy is to calculate daily pay on the basis of a 260 working day year (or in a leap year a 261 working day year). | |
5.2 | Salaries are generally reviewed annually each year in the Companys discretion commencing in 2007. Any changes will be notified to you in writing. | |
5.3 | The Company reserves the right to deduct from your Salary or from any severance pay due to you on the termination of your employment, any sums owing from you to the Company or any associated company, including but not limited to loans, debts and sums paid to you by mistake or through misrepresentation and you agree to the making of these deductions. |
2
5.4 | The Company shall make such Income Tax and National Insurance deductions from your remuneration as shall be required by law | |
6. | Expenses | |
6.1 | You will be reimbursed all out-of-pocket expenses necessarily and properly incurred by you on the business of the Company or any associated company provided you produce to the Company such evidence of actual payment of the expenses concerned as the Company reasonably requires. | |
7. | Hours of Work | |
7.1 | Your normal hours of work are 09.00 17.00 (exclusive of lunch intervals and other breaks) Monday to Friday inclusive, making a total of 35 hours per week. Times of attendance will be agreed with your Manager. You will however be expected to work such extra hours as may be reasonably required for the purpose of completing your tasks efficiently and on time. You agree that the limits on average weekly working time set out in paragraph 4(1) of the Working Time Regulations 1998 will not apply to you. However you may withdraw your consent on giving the Company not less than 3 months prior written notice. Overtime is only paid in exceptional circumstances and with the written agreement of your Line Manager. | |
8. | Mobility and Travel | |
8.1 | While the Companys offices in Winnersh, (wherever located there), will be your normal place of work, the Company reserves the right to relocate its operations or open additional sites elsewhere in the UK. If so requested by the Company on not less than one months notice, you agree to move to a new place of work or the place of work of an associated company, within a radius of 30 miles from Winnersh. | |
8.2 | You will undertake any travel either in the UK or overseas as may be necessary to carry out your responsibilities. | |
9. | Holiday | |
9.1 | Our holiday year runs from 1st January to 31st December. In addition to the normal English Public and Bank Holidays you are entitled to 25 days paid holiday in each holiday year, which accrues at the rate of 25/52 days for each complete calendar week of employment. The Company reserves the right to require you to take up to 3 days of your annual entitlement during the Christmas period. | |
9.2 | Your holiday entitlement for the year in which you start or end your employment will be calculated on a pro-rata basis. | |
9.3 | Where you have not taken your full accrued holiday entitlement on leaving you will be paid in lieu for your untaken entitlement calculated on a pro-rata basis up to the date of termination of your employment. If you have taken more holiday than your accrued holiday entitlement for that year, you agree that the Company is authorised to deduct the |
3
value of the excess days from your Salary or from any severance pay due to you on the termination of your employment. The Company reserves the right to require you to take any outstanding holiday leave during a period of notice. | ||
9.4 | You are entitled to carry forward into the next holiday year a maximum of 5 days holiday which have accrued but which have not been taken before the end of the holiday year. These 5 days must be taken by 31st March of the next holiday year. Any carried forward holiday remaining at this date will lapse. You may not take more than 30 days holiday in any one year. | |
10. | Notification of Absence | |
10.1 | If you cannot attend for work you should telephone the Company or arrange for someone to telephone or otherwise deliver a message on your behalf as soon as possible on your first day of absence and indicate when you expect to return to work. If your return to work is delayed you should contact the Company again in the same way on each following day of absence. | |
10.2 | If you are prevented by illness or accident from working for seven or more consecutive days you must provide a medical practitioners statement on the eighth day and weekly thereafter. A self-certification form must be completed and produced to the Company immediately following your return to work for shorter periods of absence. | |
11. | Sick Pay | |
11.1 | If you are entitled to Statutory Sick Pay (SSP) the Company will pay it to you. | |
11.2 | During absence due to sickness or injury, Company Sick Pay equivalent to your normal Salary, may be paid at the Companys discretion. Statutory Sick Pay will be paid in accordance with the then prevailing rules of the Statutory Sick Pay Scheme. | |
11.3 | Full details of the Company Sickness/Absence Policy and Procedure are available electronically on the Companys systems and from the Administration Office. | |
11.4 | The Company provides permanent health insurance cover. Full details of this cover (including conditions of eligibility, the rules and benefits to which cover is subject) are available from the Administration Office. The Company reserves the right to arrange equivalent cover through an alternative insurer. | |
12. | Pension Scheme | |
12.1 | The Company agrees to contribute 10% of your Salary in equal monthly instalments to an appropriate and qualified personal pension plan nominated by you. This contribution is conditional upon your making monthly contributions equal to 2.5% of your Salary to the said plan. You agree that your contributions to the plan may be made by the Company making the relevant deductions from your Salary and paying the required amount into the plan on your behalf. The said contributions are subject to the rules of the plan as amended |
4
from time to time and will be capped at Inland Revenue limits. No Contracting Out certificate is in force in respect of employment with the Company. | ||
13. | Bonus Scheme | |
13.1 | You will be eligible to participate in any bonus scheme the Company establishes from time to time (if at all), for employees of your level, subject to the rules of the scheme. For 2005 you shall be eligible for a bonus (hereinafter, the Bonus), which shall be capped at thirty percent (30%) of the portion your salary earned by you during that year, inclusive any salary paid by Emergent BioSolutions. Notwithstanding anything to the contrary contained herein, the determination as to whether any Bonus shall be awarded, and the amount of the Bonus, if any, shall be made in the sole and absolute discretion of the Board of Directors of the Company or Emergent BioSolutions, or such other person or committees as may be delegated that responsibility. The Committees criteria for awarding any Bonus shall be based on its assessment your job performance and the Companys financial performance during the applicable Period. The relative weight to be given to each such factor shall also be within the Companys sole and absolute discretion. The Company reserves the right to amend, replace or withdraw any such bonus scheme from time to time. Further details are available from the Administration Office. The fact that a bonus is paid in one or more years is no guarantee that bonuses will be paid in subsequent years. As the bonus is also intended to incentivise employees to remain in the employment of the Company, payment of any bonus is conditional on your remaining in the employment of the Company and not being under, or having given, notice to terminate your employment at the date bonus is payable. | |
14. | Life Assurance | |
14.1 | You will become a member of the Companys Life Assurance Scheme when you commence permanent employment subject to meeting any conditions of eligibility and the rules of the Scheme from time to time. (These may require you to pass a medical examination to the satisfaction of the benefit providers as a condition of cover). In the event of death during your employment the sum of four times Salary, subject to the Inland Revenue Earnings Cap from time to time, will be payable. | |
15. | Private Medical Cover | |
15.1 | You may join the Companys Private Medical Insurance Scheme at the Companys expense and you may pay for dependants (as defined in the scheme) to be included. The Company reserves the right at any time to arrange equivalent cover through an alternative insurer. The provision of cover (including alternative cover) is conditional on your satisfying any conditions (such as passing a medical examination) and accepting any restriction imposed by the insurer. Details of the scheme in operation are available from the Administration office. |
5
16. | Medical Examination | |
16.1 | The Company may reasonably require you to be examined by a Company appointed doctor at its own expense. The doctor may report to the Company and its professional advisers, on your fitness to do your job or other appropriate work. The Company may also require verification from your own GP that you are fit to return to work after a period of absence or sickness incapacity. | |
17. | Grievance and Disciplinary Procedures | |
17.1 | The Companys Grievance and Disciplinary procedures can be viewed electronically on the Companys systems and are also available from the Administration Office. It is the Companys policy to deal fairly with disciplinary issues and grievances, which arise, in accordance with these procedures. The Grievance and Disciplinary Procedures do not form part of your contract or otherwise have contractual effect As can be seen if you have a grievance relating to your employment or wish to appeal against disciplinary action or decisions, you should, in the first instance, notify your line manager in writing making it clear that you are raising it formally. If the grievance is against your line manager personally, you should notify your grievance or appeal in writing to a member of the Executive Committee. |
18.1 | The Companys e-mail and Internet system must be used for Company and only essential personal use in accordance with the Office Systems Policy which is available electronically on the Companys system and from the Administration office. |
19.1 | The Company can dismiss you without prior notice or pay in lieu (and you will not be entitled to damages) for conduct amounting to gross misconduct or any other conduct or performance issues of equivalent seriousness. A non-exhaustive list of the grounds for summary dismissal is contained in the Companys Disciplinary Procedure. | |
19.2 | The Company reserves the right to pay you your base Salary in lieu of any unexpired period of notice less income tax and employee NI contributions. | |
19.3 | Once notice of termination has been given by either party. |
(a) | the Company may send you on paid leave of absence, suspend you from performing your job and/or exclude you from entering our premises. During your suspension you will continue to receive your Salary and contractual benefits. During your employment or any notice period, the Company may, in its absolute discretion, assign you to different tasks consistent with your position or require you to perform no tasks at all. This may include requiring you to stay at home and to have no contact with the Companys clients, suppliers or employees for part or all of your suspension period. You will continue to receive your Salary and all your contractual benefits during the suspension period Your implied duties of |
6
loyalty and good faith will continue to apply whether or not you are actually working and you may not be engaged or employed by or take up any office or partnership in any other company, firm or business, or trade on your own account without the Companys written permission. | |||
(b) | you must not make any public statements in relation to the Company or your employment or its termination . |
19.4 | At the end of your employment, or earlier if the Company requests, for whatever reason you must return all Company property, including all equipment, documents, computer disks or tapes and all other tangible items in your possession or control belonging to, or containing any confidential information of, the Company or an associated employer. | |
19.5 | In the event that as a result of incapacity you became eligible to receive benefits under the Companys permanent health insurance scheme, the Company may, in its discretion, a) continue your employment only to the extent necessary and solely to ensure that you continue to be treated as an employee for the purposes of the permanent health insurance scheme or b) terminate your employment. During such time, you will not be entitled to any remuneration or other benefit from the Company and the Company will have no obligation to continue your employment or provide any work or payment to you, if you recover from the incapacity |
20.1 | You will, in fulfilling your responsibilities, have access to confidential information relating to the Company or any associated employers and develop knowledge and influence over the Companys suppliers and/or customers and/or be involved in making inventions or creating copyright material. You will be asked to sign a separate Non-Disclosure and Invention Assignment Agreement, which seeks to protect the Companys interests both during and after the termination of your employment. | |
20.2 | You shall not, either during or after your employment for whatever reason, divulge or communicate to any person or persons, except authorised members of the Company, or make use of yourself; any Confidential Information relating to the business of the Company or any associated company which may have been disclosed to you or which may otherwise have come to your attention. | |
20.3 | This restriction shall cease to apply to information or knowledge which comes into the public domain, otherwise than by reason of your default, or which is required to be disclosed by law or by a court or tribunal of competent jurisdiction. Nothing in this Agreement will prevent you making a protected disclosure under the Employment Rights Act 1996. | |
20.4 | Confidential Information includes but is not limited to business and marketing plans, customer and price lists, the requirements of customers and potential customers for products and services, management accounts, budgets and other sales or financial data, the terms on which the Company or any associated Companies do business with third parties, details of any pending or threatened litigation, details of confidential and |
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proprietary computer technology (including source and object codes), any confidential information relating to scientific data, formulae or processes, (including unpublished research and development reports and details of products and services in the course of development). | ||
20.5 | In the case of inventions employees must sign a separate claim to inventorship, which is then ratified by the R & D Management Committee or any other similar committee of the Company. |
21.1 | This contract includes your statutory particulars of employment. | |
21.2 | No collective agreements affect your terms and conditions of employment. |
22.1 | You have a legal duty to take reasonable care for the health and safety of yourself and of other persons who may be affected by your acts or omissions at work. You must also cooperate with the Company so that the Company can discharge its statutory obligations. No employee or other person shall intentionally or recklessly interfere with, or misuse, anything that is provided in the interests of health, safety or welfare. |
23.1 | Any notice to be given pursuant to these terms and conditions must be given in writing and delivered either by courier, by hand, by first class post or by facsimile. Any notice to you will be sent to your last known address or facsimile number or given to you at your place of work and any notice to the Company should be sent to its registered office from time to time. A notice will be deemed to have been served at the time of delivery if sent by courier or by hand, on completion of transmission by the sender if sent by facsimile and 2 clear days after the date of posting if sent by first class post. |
24.1 | You consent to the Company holding and processing both personal data and sensitive personal data (the latter includes your religious beliefs, your ethnic or racial origin, information relating to your physical or mental health and any unspent criminal convictions), for all purposes relating to your employment. In particular you agree that the Company can hold and process personal and sensitive personal data to: (a) pay and review your remuneration and other benefits; (b) provide and administer any such benefits; (c) determine your fitness to work for the Company or your entitlement to sick pay or maternity or other leave of absence; (d) provide information to the Inland Revenue (or other taxation authorities), the police, other regulatory bodies, the Companys legal advisers and potential purchasers of the Company or any business area in which you work and to any investors or potential investors in the Company; (e) administer and maintain personnel records (including sickness and other absence records); (f) carry out performance reviews, disciplinary or grievance procedures; (g) |
8
give references to future employers; and (h) transfer personal and sensitive personal data concerning you to a country outside the EEA (and, in particular, to the HR department of any associated employer based overseas including in the US, particularly for the purposes of HR administration) and you understand that such countries outside the EEA may not have laws to protect your personal information. |
25.1 | The terms and conditions of your employment are governed and will be construed in accordance with English law and all claims, disputes and proceedings are subject to the exclusive jurisdiction of the English courts |
associated company or associated employer means any company which from time to time is a subsidiary or a holding company of the Company or a subsidiary of such holding company and subsidiary and holding company have the meanings attributed to them by section 736 of the Companies Act 1985. | ||
any Act or delegated legislation includes any statutory modification or re-enactment of it or the provision referred to. |
You acknowledge and agree that the Employment Agreement dated January 3, 2005 between you and Emergent BioSolutions be and it hereby is terminated and superseded by this agreement; provided however, that the obligations, rights and agreements contained in Section 8 (Protection of the Company), Section 9 (Inventions, Improvements and Copyrightable Materials) and Section 12 (Additional Obligations) shall survive and inure to the benefit of Emergent BioSolutions and the Company. | ||
The letter agreement between you and Emergent BioSolutions dated September 16, 2005 shall continue to apply as it relates to the rights, obligations and agreements to serve as Chief Scientific Officer of Emergent BioSolutions during the Transition Period. | ||
You acknowledge and agree that effective November 12, 2005, you resigned as Chief Executive Officer of Emergent ImmunoSolutions Inc. |
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Signed:
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/s/ Fuad El-Hibri
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Fuad El-Hibri, Chairman of the Board |
Signed:
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/s/ Steven N. Chatfield
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Steven N. Chatfield |
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July 11, 2006
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Emergent BioSolutions Inc. | |
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300 Professional Drive, Suite 250 | |
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Gaithersburg. MD 20879 | |
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t 301 944 0290 | |
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f 301 944 0173 | |
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www.emergentbiosolutions.com | |
Dr. Steven Chatfield
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31, Kenwood Drive
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Beckingham, Kent
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UNITED KINGDOM
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RE: Role of Chief Scientific Officer
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1. | You will spend one week per month in the US and the Maryland corporate offices attending to the duties related to performing your responsibilities as CSO of Emergent BioSolutions Inc. These duties and responsibilities are set forth in Attachment 1. | ||
2. | You will be flexible regarding travel to the US in excess of one week a month on an as-needed basis. | ||
3. | You will not renew your lease for your Gaithersburg apartment which expires on August 31, 2006 and will no longer receive the monthly $1,900.00 stipend. | ||
4. | While you are in the US or elsewhere in the world performing your duties, you will submit business expenses (e.g., hotel, car rental, business meals, etc.) in accordance with the Companys reimbursement policies as they may exist from time to time. |
1. | You are not required to relocate your residence to the US. | ||
2. | You will not be required to repay the first portion of the relocation stipend in the amount of US$15,000. | ||
3. | You will no longer receive a per diem payment of $100.00 for each day that you are in the US on business in fulfilling your CSO responsibilities. | ||
4. | You have received reimbursement from the Company of all amounts related to the US$3,000 payment referenced in the penultimate paragraph on page 2 of the September 16, 2005, Letter Agreement. |
/s/ S. N. Chatfield
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Steven N. Chatfield, Ph.D.
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1. | Present at scientific conferences and meetings | ||
2. | Advise CEO, EMC, and Board of Directors on scientific matters and issues | ||
3. | Assist Business Development in identifying opportunities and assessing them as they arise | ||
4. | Support corporate interactions in connection with financing and acquisition activities | ||
5. | Assist scientific advisory panel in achieving their agreed upon objectives | ||
6. | Assist in patent prosecution matters and other actions to advance intellectual property estate of the Company |
(i) | On the date EMERGENT provides Consultant with written notice (setting out with particularity) that this Agreement is being terminated for cause. For purposes of this Agreement, Consultant shall be deemed terminated for cause if EMERGENT terminates Consultant after Consultant: |
(a) | shall have committed any act or acts of embezzlement, theft or fraud against EMERGENT; | ||
(b) | shall have been convicted of a felony or any crime involving moral turpitude, whether or not related to Consultant Services; | ||
(c) | shall have committed any act or acts of gross negligence or willful misconduct; or | ||
(d) | shall have committed a breach of the representations, warranties or covenants contained in Sections 4, 7, 9, 11 or 14 herein. |
(ii) | On the date EMERGENT terminates Consultants Services for convenience on not less than ten (10) days prior written notice. | ||
(iii) | On the date Consultant terminates the Services for any reason, provided that Consultant shall give EMERGENT ten (10) days prior written notice. |
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EMERGENT BIOSOLUTIONS INC. | THE HAUER GROUP | |||||||
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By
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/s/ Daniel J. Abdun-Nabi | By | /s/ Traci Brown-Hauer | |||||
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Printed Name: Daniel J. Abdun-Nabi | Printed Name: | |||||||
Title: Senior Vice President
Legal and Corporate Affairs and General Counsel |
Title: President |
| Consultation to CEO and Senior Management on corporate strategic issues | |
| General consultation and directed project support to Marketing and Communications Group in the area of public relations including but not limited to: |
Þ Relationship management with targeted media outlets and reporters | |||
Þ Introductions to relevant government officials | |||
Þ Introductions to potential commercial partners |
| Other projects as may be directed by the CEO and Senior Management |
| Target audiences: |
Þ
Senior Leadership and Decision Makers in First Responders Communities in Major
Cities in the US (see list below of target cities). [**]
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Þ
Senior Leadership and Decision Makers in Health Departments in major cities in the
US to help support decision makers in the first responder community when making a
medical decision surrounding the use of BioThrax,
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Specific activities targeted at these markets include the following:
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Þ
Contacting individuals within the target audiences, prioritizing and arranging
initial meetings/teleconferences with senior leadership and decision makers within the
first responder and health department community
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Þ
As needed and appropriate, attend meetings with member of the sales and marketing
team when meeting with these key officials.
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Þ
Provide input and information on senior leadership and decision makers prior to
meetings to ensure meeting materials are appropriate and targeted for the individuals
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Þ
2 to 4 meetings will be arranged per month with target audiences within the target
geographic areas.
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| Target Cities/Metro Areas (based on geography) |
Þ [**] |
Þ [**] |
| Non-Employees will be booked at the lowest air fare , coach class. Upgrading to a higher class of service at the departure airport or before will not be allowed. | ||
| Frequent flyer awards that Non-Employees accrue while on business travel for Emergent belong to Non-Employees provided there is no additional direct or indirect expense to the company. |
| Chartering or renting an airplane or private helicopter is not permitted. Personal, leased or rented aircraft may not be used for company business. |
| Consultants from the same company and/or consultants visiting Emergent on the same day must share vehicles whenever feasible. | ||
| A car may be rented when business conditions warrant. Rental is limited to midsize vehicles. | ||
| Cars should be returned with a full tank of gas to avoid inflated fuel charges unless given other instructions by the rental company. Emergent will not pay for fuel charges resulting from a failure to return a car with a full tank of gas. | ||
| Rental cars should always be inspected for damage before driving them. | ||
| The cost of any insurance covering a rental car or any damage to a rental car is the responsibility of the Non-Employee. | ||
| The company does not expect the use of personal cars for business travel. However, when appropriate, mileage at the effective rate * (rate is adjusted per IRS guidelines), parking and tolls are reimbursed. Personal cars should only be used for business travel when using a rental car creates unnecessary inconvenience to the employee. | ||
| Damage to a personal car used for company business will be reimbursed if the use was required for business. Reimbursement is limited to the persons personal automobile collision insurance deductible up to $500, or up to $500 if no collision insurance is in force. This must be reported to and approved by the CFO. |
| Emergent has arranged for special rates at certain hotels. The relevant Emergent Administrative Assistant will reserve rooms for Non-Employees at these hotels. Any exception to this (other than for unavailability) requires the approval of the CFO. | ||
| Standard rooms will normally be used unless special contract arrangements permit the use of other rooms at minimal or no extra charge. | ||
| All reservations are guaranteed for late arrival. Hotel reservations must be canceled by 4:00 PM on the scheduled day of arrival to avoid a no-show charge being made. Non-Employees are responsible for contacting the hotel by 4:00 PM if cancellation of the room is necessary. Emergent will not pay for no-show charges. | ||
| Hotel shuttle services should be used to/from airports whenever possible. Emergents travel management team will verify this service. Travel by taxi is permitted where public transportation is unavailable or inappropriate. The |
| Reasonable expenses for food and beverages consumed while traveling will be reimbursed. Detailed receipts must be turned in on everything . Food and beverage expenses should be directly related to fulfilling business objectives. | ||
| Tear tab receipts are not acceptable . | ||
| A separate receipt for alcohol must be turned in if alcoholic beverages are consumed. | ||
| As a general guideline, meal expenses should generally average out to no more than $43/day, with certain exceptions based on pricing differences between different geographic regions. | ||
| If a Non-Employee incurs a meal expense for other persons and seeks reimbursement for such additional expense, the business reason for the meal and the list of attendees must be submitted in order for reimbursement to be processed. |
| Parking fees | ||
| Toll charges | ||
| Travelers check fees for international travel only | ||
| Business telephone calls | ||
| Reasonable (one per day) personal telephone calls, with a cap of $5.00 for domestic and $25.00 for international travel | ||
| Business-related FAX | ||
| Taxi and airport shuttle transportation | ||
| Tips will be reimbursed, up to the amount specified, as follows: 20% for meals, 10% for drivers, $10.00 per week for maid service, $3.00 for valet parking, $5.00 for luggage handling. Anything over these amounts will not be reimbursed. |
| Personal charge/credit card annual fees | ||
| Normal dependent-care expenses | ||
| Club membership fees |
| Auto repairs on personal cars | ||
| Personal amenities | ||
| Gifts, flowers, contributions/awards and prizes | ||
| Pet care | ||
| Traffic fines | ||
| Hotel movies | ||
| Clothing |
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Air Travel | Original passenger coupon or invoice | ||
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Hotel | Hotel bill plus proof of payment | ||
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Car | Original rental agreement or express return receipt | ||
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Food and Beverage | Itemized receipt only (tear tab receipts are not acceptable) | ||
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Entertainment | Itemized receipt only (tear tab receipts are not acceptable) | ||
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Other Transportation |
Taxi/shuttle receipts are required.
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Leased Car | All receipts for gas and oil are required, regardless of the amount |
A. | Company must exclude an individual from EBSs premises if he/she has ever been convicted of the following types of crime: |
B. | If Companys employee will deal directly with cash on behalf of EBS or with the authorization of any type of payment, Company must exclude any individual who has ever received a misdemeanor or felony conviction for: |
C. | Other than the specific felonies listed in paragraph A (which excludes an individual from EBSs premises), Company must exclude any individual convicted of a felony, e.g. Burglary, Unauthorized Criminal Access to Computer Systems, etc., within the last five (5) years. |
D. | Company must exclude any individual convicted of a misdemeanor within the last two (2) years. Individuals with convictions for traffic violations do not fall into the exclusion category. Individuals with DUI convictions do not fall into the exclusion category unless he/she will be driving a Company vehicle, or multiple charges exist. Company should contact EBS for clarification if uncertainties exist. |
Drug, Drug Group | Typical Detection | |
or Drug Metabolites | Threshold,ng/ml | |
Amphetamines
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500-1000 | |
Barbiturates
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200-300 | |
Benzodiazepines
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300 | |
Cannabinoids (marijuana)
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15-50 | |
Cocaine metabolites
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150-300 | |
Opiates (Codeine, Morphine,
Oxycodone, Hydromophone,
Hydrocodone)
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300 | |
Methadone
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300 | |
Phencyclidine (PCP)
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25 |
§ | Abide by applicable governmental and internal health, safety and environmental requirements. | |
§ | Has a documented and written Health, Safety and Environmental policy and management system (that is reviewed by EBS), and is consistent with the potential risk and scope of work to meet the performance criteria of that system. |
§ | Employ or cause to be employed only persons who are skilled in the work to be performed and trained in applicable HS&E policies and procedures. | |
§ | Use or provide equipment that is safe to operate and meet governmental requirements. | |
§ | Record work hours and HS&E incidents and report to EBS as requested by EBS. Follow-up to prevent recurrence of incidents. | |
§ | Monitor and evaluate Companys HS&E performance and take corrective action as needed. | |
§ | Provide authorized EBS representatives access to Companys work area(s). |
1. | For purposes of this Agreement, the terms listed below shall have the meaning ascribed to them in this Section. | |
Affiliates when used with respect to any Person shall mean any Person which, directly or indirectly, controls or is controlled by or is under common control with another Person. For purposes of this definition, control (including the correlative meanings of the terms controlled by and under common control with), with respect to any Person, shall mean possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of another Person, whether through the ownership of voting securities or by contract or otherwise. | ||
AVA shall mean anthrax vaccine adsorbed. | ||
Availabilty Date shall mean the date on which BIOPORT has 100,000 doses of AVA or PBT Vaccine that have (i) been released for distribution by the Food and Drug Administration and the Quality Assurance Department of BIOPORT and (ii) been made available by the U.S. Department of Defense for sale. | ||
BIOPORT shall mean, for purpose of this Agreement, BIOPORT and any Affiliate or joint venture in which BIOPORT is a participant. | ||
Confidential Information shall mean information relating to the buss ness, prospective business, technical processes, finances, price lists or lists of customers and suppliers of a Party which is provided to the other Party in connection with this Agreement and is designated as confidential or proprietary by such Party. Notwithstanding the above, Confidential Information shall not include information which (i) was known to the Party receiving the information prior to the date of this Agreement, (ii) has been generally known to others in the trade or business of the Parties, (iii) has been part of public knowledge or the literature otherwise than as a result of any breach of confidence by the Party receiving the information, (iv) has become available to the Party receiving the information from a third party not representing either of the Parties, or (v) has been independently acquired by the Party receiving the information as a result of work carried out by an employee of such Party to whom no disclosure of such information shall have been made. | ||
Dollars and $ shall mean dollars in the legal tender of the United States of America. | ||
PBT Vaccine shall mean the pentavalent botulinum toxoids vaccine. | ||
Person shall mean and includes natural persons, corporations, limited liability companies, limited partnerships, general partnerships, joint stock companies, joint ventures, associations, companies, trusts, lenders, trust companies, -land trusts, business trusts, or other organizations, irrespective of whether they are legal entities, and governments and agencies and political subdivisions thereof | ||
Products shall mean AVA, the PBT Vaccine, and such other vaccines against any biological warfare threat agent for which BIOPORT may be duly licensed to manufacture or sell, currently or in the future. |
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Territory shall mean all countries of the Middle East and North Africa, except Israel and those countries to which export of AVA or PBT vaccine is prohibited by the U.S. government; provided, however, if such prohibition is subsequently eliminated, then any such country for which the prohibition has been eliminated shall be deemed to be included within the definition of Territory. | ||
Total Contract Value shall mean the gross amount promised to be paid to BIOPORT from any Person in the Territory for the purchase of the Products. | ||
2. | APPOINTMENT |
2.1 | BIOPORT appoints INTERGEN to be its sole and exclusive marketing representative with regard to the sale and promotion of the Products in the Territory. The Parties agree that BIOPORT has the right to retain other representatives for the sale and promotion of the Products in the Territory; provided, however, that such retention shall not limit or relieve the obligation of BIOPORT to pay fees to INTERGEN that may otherwise be due under this Agreement. INTERGEN shall provide services to BIOPORT in accordance with the terms and conditions set out in this Agreement. | ||
2.2 | The Parties acknowledge and agree that INTERGEN shall have the right to, in its sole discretion, hire such employees, engage such consultants and appoint such agents as it deems appropriate to perform its obligations hereunder. INTERGEN further agrees that such consultants, employees or agents shall be bound by the restrictions of Paragraphs 3.2 and 12 herein. |
3. | DUTIES OF INTERGEN |
3.1 | Throughout the term of this Agreement, INTERGEN shall perform a variety of marketing and other activities as follows: |
3.1.1 | Assist BIOPORT with the promotion and sale of the Products throughout the Territory and assist with inquiries or orders received for Products; | ||
3.1.2 | Advise BIOPORT on advantageous pricing structures for the Products, from time to time; | ||
3.1.3 | Safeguard the property, rights, and interests of BIOPORT and assist BIOPORT in taking all steps to defend the rights of BIOPORT; | ||
3.1.4 | Assist BioPort with promptly obtaining and maintaining all licenses, permits and authorizations as may be required from time to time in connection with the supply of the Products to the Territory; | ||
3.1.5 | Supply customers and potential customers with (i) such literature as may be commercially prudent for the purpose of promoting sales of the Products within the Territory and (ii) catalogs and such other information that are necessary for proper presentation and solicitation of Product sales; |
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3.1.6 | Promptly forward to BIOPORT a duplicate copy of every invoice, communication, letter or opportunity relating to the supply of the Products (directly or indirectly) to Persons in the Territory; | ||
3.1.7 | Keep BIOPORT informed from time to time as to the market for the Products in the Territory, the prices at which customers and potential customers are prepared to buy the Products, and use its best efforts to give BIOPORT notice of any change in the market price structure for the Products; | ||
3.1.8 | Take, particularly in light of the preferred customer status to be granted to the U.S. Government in terms of pricing and the Products supplied, all reasonable and necessary steps to ensure that sales of Products to Persons in the Territory will be used for the internal requirements of the Persons acquiring the Products from BIOPORT and such Products are not acquired for purposes of resale or other transfer into the private or foreign public sectors; | ||
3.1.9 | Take all reasonable and necessary steps to ensure that its sales of Products to Persons inside of the Territory are under terms and conditions that do not undermine other existing or potential sales of Products outside the Territory; and | ||
3.1.10 | Use its best efforts to sell, at a minimum, 100,000 doses of AVA, in the aggregate, to Persons in the Territory per year, pursuant to orders received by BIOPORT. |
3.2. | INTERGEN shall perform the above-described in accordance with the highest business standards and with its best efforts, and will not perform any acts which will or may reflect adversely upon the business, integrity, or goodwill of BIOPORT. INTERGEN shall not, and shall ensure that its officers, employees and agents do not, make any representation or give any warranty in relation to the Products other than those which are contained in BIOPORTs current printed literature or packaging or which have been specifically previously authorized in writing by BIOPORT. It is understood by the Parties that INTERGEN shall not accept orders or make contracts on behalf of BIOPORT other than subject to confirmation and acceptance in writing by BIOPORT, nor shall INTERGEN incur any liability of whatever nature on behalf of BIOPORT or pledge BIOPORTs credit. |
4. | DUTIES OF BIOPORT | |
BIOPORT shall: |
4.1 | Use its best efforts to promptly obtain and maintain all licenses, permits and authorizations as may be required from time to time in connection with the supply of the Products to the Territory; | ||
4.2 | Supply INTERGEN, at the expense of BIOPORT, with (i) such literature as INTERGEN shall reasonably request from time to time for the purpose of promoting sales of the Products within the Territory and (ii) catalogs and such other information as, in BIOPORTs opinion, are necessary for proper presentation and solicitation of Product sales; |
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4.3 | Promptly forward to INTERGEN a duplicate copy of every invoice, communication, letter or opportunity relating to the supply of the Products (directly or indirectly) to Persons in the Territory; | ||
4.4 | Keep INTERGEN informed as to the Products it has available for sale in the Territory, the prices at which it is prepared to sell the Products, and use its best efforts to give INTERGEN at least three (3) months advance notice of any proposed change in its price structure; | ||
4.5 | Permit INTERGEN by nameplate at its office and/or in its letter heading to indicate that INTERGEN is the marketing representative of BIOPORT for the Products in the Territory subject to such indication having been previously approved in writing by BIOPORT (such approval not to be unreasonably withheld or delayed) and provided that such indication shall cease on the expiration or earlier termination of the Agreement (for any cause); | ||
4.6 | Allow INTERGEN to have access to the relevant books and accounts and records of BIOPORT at all reasonable times so as to ensure that all invoices relating to the supply of the Products to the Territory have been properly recorded; | ||
4.7 | Take, particularly in light of the preferred customer status to be granted to the U. S. Government in terms of pricing and the Products supplied, all reasonable and necessary steps to ensure that sales of Products to Persons in the Territory will be used for the internal requirements of the Persons acquiring the Products from BIOPORT and such Products are not acquired for purposes of resale or other transfer into the private or foreign public sectors; | ||
4.8 | Take all reasonable and necessary steps to ensure that its sales of Products to Persons outside of the Territory are under terms and conditions that do not undermine other existing or potential sales of Products within the Territory. | ||
4.9 | Use its best efforts to supply, at a minimum, 100,000 doses of Anthrax, in the aggregate, to Persons in the Territory per year, pursuant to orders received by BIOPORT; and | ||
4.10 | Advise INTERGEN, in writing, of all established policies and procedures of BIOPORT by which INTERGEN shall be expected to abide and shall promptly notify INTERGEN, in writing, of any changes to such policies and procedures. |
5. | INDEMNIFICATION | |
BIOPORT shall unconditionally and irrevocably indemnify and hold harmless INTERGEN, its
officers, employees and representatives from all losses (except indirect, incidental or
consequential losses), liabilities, claims, demands, expenses, and costs which INTERGEN,
its officers, and/or employees may suffer or incur as a direct result of any
claim or demand by any third party relating to the Products or any of them-, provided,
however, that the indemnity contained in this Subparagraph shall not apply to the extent
that any losses, liabilities, claims, demands, expenses, and costs should arise from the
gross negligence or willful misconduct of
|
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INTERGEN its officers, employees or representatives, and provided, further, that INTERGEN shall: |
5.1 | At the expense of BIOPORT, render such reasonable assistance to BIOPORT as BIOPORT may require in respect of such claim or demand; | ||
5.2 | Not make any admissions in respect of such claim or demand or otherwise prejudice the position of BIOPORT in respect of such claim or demand; and | ||
5.3 | The provisions of this Section shall survive the expiration or earlier termination of this Agreement; |
6. | COMPENSATION |
6.1 | In compensation for the marketing services provided by INTERGEN and any and all of its subagents under this Agreement, BIOPORT shall pay to INTERGEN a fee for sales of the Products supplied by or on behalf of BIOPORT to any Person in the Territory, regardless of whether the sale was instigated by INTERGEN at forty percent (40%) of Total Contract Value. | ||
6.2 | The fee herein in respect of any Products shall be paid to INTERGEN in Dollars. Upon the payment of any fee, INTERGEN shall deliver to BIOPORT an acknowledgement of receipt therefor. | ||
6.3 | The fee due hereunder shall be paid to INTERGEN within seven (7) banking days (excluding Saturdays and Sundays and days in which banks in Michigan are authorized or obligated by law to be closed) after payment for the Products has been received by or on behalf of BIOPORT. In the case of BIOPORTs receipt of any partial payment hereunder, BIOPORTs shall pay INTERGEN the fee on a pro rata basis. | ||
6.4 | As regards orders for the supply of the Products to Persons within the Territory which are received by BIOPORT during the term of this Agreement but in respect of which payment has not been made to BIOPORT at the expiration or earlier termination of this Agreement, BIOPORT shall pay to INTERGEN (or as INTERGEN shall reasonably direct in writing) fees in accordance herewith in respect of each such order as and when payment has been received by BIOPORT for the Products that are the subject of such order. For any sale of the Products for which contracts are concluded for the benefit of BIOPORT with Persons in the Territory resulting from standing orders, follow-on orders, extensions, or renewals of orders generated by INTERGEN during the term of this Agreement, such sales shall be deemed sales under this Agreement for which INTERGEN shall be paid fees in accordance with the provisions of this Agreement. | ||
6.5 | In the event that BIOPORT fails to make any payment due under this Agreement to INTERGEN by the due date for such payment, interest shall accrue and be payable on the unpaid amount at the annual rate of five percent (5%) above the prime rate published by The Wall Street Journal (New York edition) as of the date on which INTERGEN should have received such payment until payment, in full, is received by INTERGEN. |
6
6.6 | INTERGEN shall be responsible for all out-of-pocket expenses incurred by it in the performance of its duties hereunder. | ||
6.7 | The Parties agree that INTERGEN may present additional sales opportunities to BIOPORT outside of the Territory on a non-exclusive basis. The Parties, in such an instance, shall negotiate in good faith the compensation due INTERGEN, if any. |
7. | DURATION AND TERMINATION |
7.1 | The term of this Agreement shall commence on the Effective Date and unless previously terminated in accordance with its provisions, this Agreement shall terminate at midnight on the last day of the third (3rd) year from the Availability Date. | ||
7.2 | This Agreement shall be automatically extended for an additional five (5) year term upon the same terms and conditions if BIOPORT achieves $5,000,000 of sales in the Territory during the initial three (3) year term of the Agreement. As used in this Section, sales means the Total Contract Value of completed orders, orders received but not completed and sales contracts entered into but not fully performed as of the expiration of the three (3) year initial term of this Agreement. | ||
7.3 | Either Party may terminate this Agreement at any time by notice in writing to the other Party if the other Party commits a material breach of any of the material provisions of this Agreement and falls to remedy the breach within a reasonable time and in any event not less than sixty (60) days from the date of the notice requiring it to do so. If a non-financial breach cannot reasonably be cured, the Parties shall negotiate in good faith for an additional sixty (60) days to attempt to agree upon an alternative performance by the breaching Party or the payment of damages to the non-breaching Party that will constitute a cure and will be deemed to terminate the breach, it being acknowledged that if no such agreement is reached within the additional sixty (60) days. The breach at issue shall be deemed a default and the non-breaching Party may thereafter terminate this Agreement by written notice to the other Party with immediate effect. | ||
7.4 | In the event that BIOPORT shall not have at least 100,000 doses reasonably available for sale by INTERGEN, the Parties shall negotiate an extension of the term of this Agreement as provided in paragraphs 7.1 and 7.2. The Parties shall not unreasonably withhold consent to such extension. | ||
7.5 | The termination of this Agreement shall not affect any accrued rights or liabilities of either Party nor shall it affect the coming into force or continuance in force of, any provision of this Agreement which is expressly or impliedly intended to come into or remain in force on or after such termination. |
8. | DISPUTE RESOLUTION AND GOVERNING LAW | |
All disputes arising between the Parties shall be finally settled by binding arbitration before a single arbitrator in Lansing, Michigan, in accordance with the Commercial Arbitration Rules of the American Arbitration Association. Any award rendered by the arbitrator shall be final and may be enforced by any court of competent jurisdiction. This Agreement shall be governed by |
7
and construed in accordance with laws of the State of Michigan, excluding any conflicts of law rules that would refer the choice of law to another jurisdiction. |
9. | NON-SOLICITATION | |
INTERGEN agrees that during the term of this Agreement, and for a period of twelve (12) consecutive months after termination of such Agreement INTERGEN will not i) directly or indirectly induce or attempt to induce or otherwise counsel, advise, solicit or encourage any employee to leave the employ of BIOPORT or accept employment with any other person or entity, ii) directly or indirectly induce or attempt to induce or otherwise counsel, advise, solicit or encourage any person who at the time of such inducement, counseling, advice, solicitation or encouragement had left the employ of BIOPORT within the previous six (6) months to accept employment with any person or entity besides BIOPORT; and iii) solicit, interfere with, or endeavor to cause any customer, client, or business partner of BIOPORT to cease or reduce its relationship with BIOPORT or induce or attempt to induce any such customer, client, or business partner to breach any agreement that such customer, client, or business partner may have with BIOPORT. | ||
10. | BIOPORT REPRESENTATIVE | |
INTERGEN shall take direction and guidance in performing its services hereunder from Robert Bidlingmeyer, Vice President, Marketing of BIOPORT, or such other persons as may be designated from time to time in writing. | ||
11. | INDEPENDENT CONTRACTORS | |
With respect to the subject matter of this Agreement, the Parties are and remain independent contractors. This Agreement shall not be deemed to create a joint venture, partnership, association, or agency between the Parties. INTERGEN is not authorized to incur or create any obligation express or implied on behalf of BIOPORT or to bind BIOPORT in any manner whatsoever. The Parties understand and agree that this Agreement is not a contract of employment, or an offer to enter into a contract of employment. The Parties further agree that INTERGEN shall have sole control of the manner and means of performing the services. BIOPORT shall not have the right to require that INTERGEN or its employees do anything that would jeopardize the relationship of independent contractor between the Parties. INTERGEN shall have the right to appoint and shall be solely responsible for its own workforce, who shall be its own employees. | ||
12. | COMPLIANCE WITH FOREIGN CORRUPT PRACTICES ACT | |
INTERGEN, on its own behalf and on behalf of its owners, managers, affiliates, agents and
related entities, warrants, represents, and agrees that (i) neither it nor its owners,
managers, affiliates, agents or related entities are officials or candidates of any
government, governmental agency or instrumentality, or political party, (ii) it is aware of
the requirements of applicable law including the U.S. Foreign Corrupt Practices Act
(FCPA) and the legal prohibitions on direct or indirect improper payments or gifts to
foreign officials or candidates, (iii) it will comply with all applicable laws including
the FCPA, and use no part of the above commissions to make any improper or illegal
payments, (iv) it will, upon the Companys request, annually certify such
|
8
compliance to the Company, and notify the Company of any relevant change in the status of its owners, managers, affiliates, agents or related entities, (v) it will indemnify the Company and its officers, directors, employees, agents and affiliates for any violation of such laws, (vi) in the event of any such violation, this Agreement will immediately terminate without the need for notice, and (vii) in such event INTERGEN will forfeit any right to any accrued and unpaid commissions and compensation under this Agreement. | ||
13. | CONFIDENTIALITY |
13.1. | During the term of this Agreement and for a period of two (2) years following its termination (for whatever cause) or expiration, each Party will keep confidential the terms and conditions of this Agreement (but may acknowledge the existence of the relationship between the Parties) and all Confidential Information received from the other Party and will not use the same but, to the extent necessary to implement the provisions of this Agreement, each Party may disclose the Confidential Information to such of its customers, officers, or employees as may be reasonably necessary or desirable provided that before any such disclosures each Party shall make such persons aware of its obligations of confidentiality under this Agreement and shall at all times use its best efforts to procure compliance by such persons therewith. | ||
13.2. | Notwithstanding the provisions of Section 11.1, the Parties agree that the terms and conditions of this Agreement may be disclosed to the U.S. Government, including any division of the military, in connection with the negotiation or sale of any of the Products to such entity. In such cases, the Parties shall agree as to the best means of disclosure in order to assure the continued protection of Confidential Information. | ||
13.3. | Either Party may demand the return of the Confidential Information at any time by notice in writing given to the other Party. On the giving of such notice, the Party served with such notice shall deliver or procure the delivery to the other Party or to its order of each and every original and copy document and thing reproducing, containing, or embodying any Confidential Information. |
14. | FORCE MAJEURE |
14.1. | The obligations of a Party under this Agreement shall be suspended during the period and to the extent that such Party is prevented or hindered from complying therewith by any cause beyond its reasonable control including (insofar as beyond such control but without prejudice to the generality of the foregoing expression) strikes, lock-outs, labor disputes, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood or storm. | ||
14.2. | In the event of either Party being so hindered or prevented such Party shall give notice of suspension as soon as reasonably practicable to the other Party stating the date and extent of such suspension and the cause thereof and the omission to give such notice shall forfeit the rights of such Party to claim such suspension. Any Party whose obligations have been suspended as aforesaid shall resume the performance of such obligations as soon as reasonably practicable after the removal of the cause and shall so notify the other Party. In the event that such cause continues for more than six (6) months, either Party |
9
may terminate this Agreement upon giving to the other Party not less than sixty (60) days notice. |
15. | ENTIRE AGREEMENT | |
This Agreement constitutes the entire understanding between the Parties with respect to the subject matter of this Agreement and supersedes all prior agreements, negotiations and discussions between the Parties relating thereto, with the exception of the Termination and Settlement Agreement entered into of even date herewith. | ||
16. | AMENDMENTS | |
No amendment or variation of this Agreement shall be effective unless in writing and signed by a duly authorized representative of each of the Parties. | ||
17. | HEADINGS | |
Section headings shall not form part of this Agreement for the purposes of its interpretation. | ||
18. | ASSIGNMENT | |
Neither Party shall without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed, assign, transfer, sub-contract, charge, delegate or deal in any other manner with this Agreement or its rights or duties hereunder or part thereof, or purport to do any of the same, except, however, it is agreed that INTERGEN may assign, in whole or in part, its rights and obligations under this Agreement to an Affiliate without obtaining the consent of the Company. In the event that INTERGEN assigns any of its rights and interests to an Affiliate in accordance with this provision, it shall provide the Company with notice of such assignment within a reasonable period of time of such assignment | ||
19. | WAIVER | |
The failure of a Party to exercise or enforce any rights under this Agreement shall not be deemed to be a waiver thereof nor operate so as to bar the exercise or enforcement thereof at any time or times thereafter. |
10
20. | COUNTERPARTS | |
This Agreement may be signed in two counterparts, both of which taken together shall constitute one and the same Agreement. Either Party may enter into the Agreement by signing either such counterpart. | ||
21. | NOTICES | |
Any notice given under this Agreement shall be in writing and shall be given by delivering the same by hand at, or by sending the same by prepaid first class post (airmail if to an address outside the country of posting) or confirmed facsimile to the address of the relevant Party set out in this Agreement or such other address as either Party may notify to the other from time to time. Notices delivered in accordance with this provision shall be deemed delivered on the day delivered by hand or confirmed facsimile and three (3) days after delivery by prepaid first-class post. | ||
22. | REMEDIES NOT EXCLUSIVE | |
No remedy conferred by any of the provisions of this Agreement is intended to be exclusive of any other remedy and each and every remedy shall be cumulative and shall be in addition to every other remedy given under this Agreement or now or hereafter existing in law or in equity or by statute or otherwise. | ||
23. | SEVERABILITY | |
If any court of competent jurisdiction finds any provision of this Agreement to be unenforceable or invalid, then such provision shall be ineffective to the extent of the courts finding without affecting the enforceability or validity of the remaining provisions of this Agreement. |
BIOPORT CORPORATION | INTERGEN N.V. | |||||||||||
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By | /s/ Robert G. Kramer | By | /s/ Ibrahim El Hibri | ||||||||
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Ibrahim El Hibri | |||||||||||
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Its | Chief Financial Officer | Its | Chairman | ||||||||
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11
PAGE | ||||||
1.
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Lease of Premises | -1- | ||||
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2.
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Basic Lease Provisions | -2- | ||||
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3.
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Term | -4- | ||||
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4.
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Possession and Commencement Date | -4- | ||||
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5.
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Rent | -6- | ||||
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6.
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Rent Adjustments | -8- | ||||
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7.
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Operating Expenses | -8- | ||||
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8.
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Rentable and Usable Area | -14- | ||||
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9.
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Security Deposit | -15- | ||||
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10.
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Use | -16- | ||||
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11.
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Brokers | -19- | ||||
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12.
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Holding Over | -19- | ||||
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13.
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Taxes on Tenants Property | -20- | ||||
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14.
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Condition of Demised Premises | -21- | ||||
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15.
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Common Areas, Roof and Parking Facilities | -21- | ||||
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16.
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Utilities and Services | -22- | ||||
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17.
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Alterations | -25- | ||||
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18.
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Repairs and Maintenance | -27- | ||||
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19.
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Liens | -28- |
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PAGE | ||||||
20.
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Indemnification and Exculpation | -29- | ||||
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21.
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Insurance - Waiver of Subrogation | -30- | ||||
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22.
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Damage or Destruction | -32- | ||||
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23.
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Eminent Domain | -34- | ||||
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24.
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Defaults and Remedies | -35- | ||||
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25.
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Assignment or Subletting | -39- | ||||
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26.
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Attorneys Fees and Costs | -42- | ||||
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27.
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Bankruptcy | -42- | ||||
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28.
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Estoppel Certificate | -43- | ||||
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29.
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Intentionally Omitted | -43- | ||||
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30.
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Definition of Landlord; Limitation of Landlords Liability | -43- | ||||
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31.
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Project Control by Landlord | -44- | ||||
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32.
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Quiet Enjoyment | -45- | ||||
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33.
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Quitclaim Deed | -45- | ||||
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34.
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Rules and Regulations | -46- | ||||
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35.
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Subordination and Attornment | -46- | ||||
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36.
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Surrender | -47- | ||||
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37.
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Waiver and Modification | -47- | ||||
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38.
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Waiver of Jury Trial and Counterclaims | -47- | ||||
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39.
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Intentionally Omitted | -48- | ||||
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40.
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Hazardous Materials | -48- | ||||
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41.
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Right Extend Term | -51- |
ii
PAGE | ||||||
42.
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Tenants Right for Early Termination | -52- | ||||
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43.
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Miscellaneous | -53- |
iii
2.1.1 | Address of the Building: 300 Professional Drive, Gaithersburg, Maryland 20879 | ||
2.1.2 | Designation of the Demised Premises: Suite(s): 100 Floor(s): first | ||
2.1.3 | (a) Rentable Area of Demised Premises: 24,164 sq. ft. | ||
(b) Rentable Area of Building: 47,558 sq. ft. | |||
2.1.4 |
Initial Basic Annual Rent for the Demised Premises:
(24,164 sq.ft.) x ($1.4275 per sq.ft.) x (12 months) = $413,929.32 |
||
(a) Initial Basic Annual Rent for Existing Space:
(15,054 sq.ft.) x ($1.4275 per sq.ft.) x (12 months) = $257,875.02 |
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(b) Initial Basic Annual Rent for Block A Space:
(4,461 sq.ft.) x ($1.4275 per sq.ft.) x (12 months) = $ 76,416.93 |
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(c) Initial Basic Annual Rent for Block B Space:
(4,649 sq.ft.) x ($1.4275 per sq.ft.) x (12 months) = $ 79,637.37 |
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2.1.5 |
Initial Monthly Rental Installments of Basic Annual
Rent for the Demised Premises:
(24,164 sq.ft.) x ($17.13 per sq.ft.) /12 = $34,494.11 |
||
2.1.6 | Tenants Pro Rata Share: 50.81% | ||
2.1.7 | (a) Term Commencement Date: As defined in Section 4.2 hereof. | ||
(b) Rent Commencement Date: As defined in Section 4.2 hereof. | |||
(c) Term Expiration Date: 120 calendar months from the Term Commencement Date, subject to extension or earlier termination as provided herein. |
- 2 -
2.1.8 | Security Deposit: $173,888.98 (i.e. 6 x (.1722 x 24,164 x $67/12) + 34,494.11) subject to adjustment in accordance with Section 9 hereof; provided that the security deposit held by Landlord under the Existing Lease in the amount of $16,935.15 , plus interest in the amount of $ 10,355.35 shall be retained by Landlord and applied toward this amount. | ||
2.1.9 | Permitted Use: Scientific research and development, including facilities for animals and bio-hazard level 3 (BL3) and other types of laboratories and related office, conference, library, computer and storage uses consistent with Section 10 hereof. | ||
2.1.10 | Address for Rent Payment (rent checks shall be made payable to Landlord): | ||
135 N. Los Robles Avenue, Suite 250
Pasadena, CA 91101 Attention: Accounts Receivable |
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Address for Notices to Landlord: | |||
135 N. Los Robles Avenue, Suite
250
Pasadena, CA 91101 Attention: General Counsel |
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2.1.11 |
Address for Notices to Tenant:
300 Professional Drive, Suite 100 Gaithersburg, MD 20879 Attention: Greg Zakarian |
||
With a copy to: | |||
300 Professional Drive, Suite 100
Gaithersburg, MD 20879 Attention: V.M. Esposito |
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With a copy to: |
- 3 -
Covington & Burling
1201 Pennsylvania Ave. P.O. Box 1566 Washington, DC 20044 Attn: Alfred H. Moses, Esq. |
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2.1.12 | Guarantor of Lease: None. | ||
2.1.13 | The following Exhibits are attached hereto and incorporated herein: |
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Exhibit A | Demised Premises | ||
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Exhibit B | Land | ||
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Exhibit C | Work Letter | ||
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Exhibit D-1 | Commencement Date | ||
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Exhibit D-2 | Improvement Rent Commencement Date | ||
|
Exhibit E | Rules and Regulations | ||
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Exhibit F | Existing Tenant Fixtures | ||
|
Exhibit G | Estoppel Certificate |
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Landlord: | ||||||
|
||||||
ARE-QRS, CORP., | ||||||
a Maryland corporation | ||||||
|
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|
By: | /s/ Lynn Anne Shapiro | ||||
|
||||||
Name: Lynn Anne Shapiro | ||||||
Its: General Counsel | ||||||
|
||||||
Tenant: | ||||||
|
||||||
ANTEX BIOLOGICS INC., a
Delaware corporation |
||||||
|
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|
By: | /s/ Gregory C. Zalcarian | ||||
|
||||||
Name: Gregory C. Zalcarian | ||||||
Its: Vice President + Chief Financial Officer |
- 56 -
First Amendment to Antex Lease | Page - 2 |
First Amendment to Antex Lease | Page - 3 |
First Amendment to Antex Lease | Page - 4 |
TENANT:
ANTEX BIOLOGICS INC., a Delaware corporation |
||||
By: | /s/ Robert G. Kramer | |||
Name: | Robert G. Kramer, Sr. | |||
Title: | President | |||
LANDLORD:
ARE-QRS CORP., a Maryland corporation |
||||
By: | /s/ Jennifer Pappas | |||
Name: | Jennifer Pappas | |||
Title: | V.P. & Assistant Secretary |
First Amendment to Antex Lease | Page - 5 |
:
13
th
December 1996
:
SLOUGH PROPERTIES LIMITED
:
234 Bath Road Slough SL1 4EE
:
448911
:
AZUR ENVIRONMENTAL LIMITED
:
The Coach House 24A Tile House
Street Hitchin Hertfordshire SG5
2DY
:
2538199
:
None
:
the area from time to time comprising the
Landlord's estate at Winnersh Triangle
Workingham of which the Premises form part the
present such area being shown for identification
only edged red on the Estate Plan
:
the land off Eskdale Road on the
Estate shown edged red on the Lease Plan
:
the building (presently known as Winnersh
540) on the Land which (with the Fixtures
and any car parking and landscaping
facilities) is described in the First
Schedule
:
25
th
November 1996
:
20 years together with the period of any
continuation or extension of the tenancy
granted by this Lease
:
9
th
December 1996
:
until 25
th
May 1997 the sum of
£47.916 per annum and thereafter £95.832
per annum subject to review as provided in
this Lease
:
25
th
November 2001 and each
fifth anniversary of that date
:
use for any purpose within Classes B1 and
B8 of the Schedule to the Town and Country
Planning (Use Classes) Order 1987 (as
amended or replaced from time to time)
CLAUSE
SUBJECT
DEFINITIONS
INTERPRETATION
DEMISE
TENANTS COVENANTS
Payment of rent
Interest on late payments
Payment of rates etc
Exterior painting
Interior painting
Repair
Yielding up
Reinstatement
Landlords access
Default remedies of the Landlord
Signs and aerials
Use
Refuse and rubbish
Nuisance
Estate regulations
Estate Roads and Accessways etc
Acts prejudicial to insurance
Safeguarding the Premises
Planning Applications
Alterations
CLAUSE
SUBJECT
Statutory obligations
Alienation
Registration of dealings
Reletting and sale boards
Costs of licences and notices as to breach of covenant
Indemnity
VAT
Defects
Costs of party items
Documents affecting title
LANDLORDS COVENANTS
Quiet Enjoyment
Insurance
Estate Roads and Parking etc
CONDITIONS
Repossession on Tenants default
Benefit of insurance and abatement of rent
Notices
Repair of Estate Roads etc
Closure of facilities
RENT REVIEW
TENANTS OPTION TO DETERMINE
SURETY
Building
Part 1
Rights
Part 2
Exceptions and Reservations
Obligations of the Surety
Rent review memorandum
Documents and matters affecting title
Part 1
Service Charge for the Estate
Part 2
Costs or Winnersh 500 facilities
Part 3
Costs of Additional Access
Materials referred to in clause 4.18.2
1. | DEFINITIONS | |
In this Lease the following expressions have the meanings indicated: |
|
Accessways | the roads and ways shown for the purpose of identification only hatched brown on the Lease Plan | ||
|
||||
|
the Act | means the Landlord and Tenant (Covenants) Act 1995 | ||
|
||||
|
Additional Access | the areas shown for the purpose of identification only hatched brown and cross hatched black on the Lease Plan | ||
|
||||
|
Adjoining Premises | the premises known as Winnersh 545 demised by a lease of even date made between the Landlord and the Tenant | ||
|
||||
|
Authorised | the meaning defined in and for the purposes of | ||
|
||||
|
Guarantee Agreement | Section 16 of the Act and the form of such Agreement shall be as reasonably required by the Landlord | ||
|
||||
|
Common Areas | the Estate other than the Premises and other areas let or intended by the Landlord to be let but including the whole of the Estate Roads | ||
|
||||
|
Conducting Media | all sewers drains pipes wires watercourses subways cables apparatus conduits and any other media or works for the conduct or transmission of any service matter or material (including any |
1
|
media and works in respect of the sprinkler system at the Estate) | |||
|
||||
|
Estate Plan | the plan marked Estate Plan attached to this Lease |
|
Estate Roads | 1. | the roads pavements and paths shown for the purpose of identification only hatched brown on the Estate Plan (or any road pavement or path at any time replacing any of them) and | |||||
|
||||||||
|
2. | such other roads pavements and paths at Winnersh Triangle (whether or not on or forming part of the Estate) as may from time to time serve or be available for use generally by tenants and occupiers in connection with premises on the Estate but excluding any that may be or become any public highway or footpath |
|
First Schedule | the schedule referred to in the First Schedule including any amended or substituted schedule describing any other building (and its fixtures equipment and other items) erected on the Land by the Landlord pursuant to this Lease | ||
|
||||
|
Fixtures | the Landlords fixtures from time to time on or forming part of the Land including the fixtures equipment and items which with the Building are described in the First Schedule |
2
|
Full Reinstatement Value | the costs (including demolition professional fees and any value added tax payable) which would be likely to be incurred in carrying out repair or reinstatement in accordance with the requirements of this Lease at the time when such repair or reinstatement is likely to take place having regard to current building techniques and materials | ||
|
||||
|
Insured Risks | fire lightning earthquake explosion aircraft riot storm tempest flood burst pipes malicious damage and impact damage and such other insurable risks and on such terms and subject to such exclusions as the Landlord may from time to time consider reasonably necessary but excluding any risks which the Landlord shall decide from time to time not to include in any policy (whether on the grounds of unavailability of insurance cover for that risk or otherwise) but so that the Landlord shall give at least fourteen days prior notice in writing to the Tenant of any risk ceasing to be covered by any policy | ||
|
||||
|
Landscaped Areas | those parts of the Land as are hatched green on the Lease Plan | ||
|
||||
|
Lease Plan | the plan marked Lease Plan attached to this Lease | ||
|
||||
|
Loss of Rent | the loss of the rent first reserved by clause 3 for such period (being not less than three years) as |
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may reasonably be required by the Landlord from time to time having regard to the likely period required for reinstatement in the event of both partial and total destruction and in an amount which would take into account potential increases of rent in accordance with clause 7 | |||
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Parking Area | such area or areas within the Land as are designated for parking and shown on the Lease Plan as demised car parking | ||
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Planning Acts | includes the Town and Country Planning Act 1990 the Planning (Listed Buildings and Conservation Areas) Act 1990 the Planning (Hazardous Substances) Act 1990 and (the Planning (Consequential Provisions) Act 1990 | ||
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Premises | the Land together with the Building (or any other building erected by the Landlord in its place) and all additions and the Fixtures and a reference to the Premises includes a reference to any part | ||
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Prescribed Rate | three per centum above the Base Rate of National Westminster Bank PLC from time to time (or such other clearing bank as the Landlord shall nominate) or (if such rate shall cease to be published) such other reasonable or comparable rate as the Landlord shall from time to time designate | ||
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Service Charge | the aggregate of the costs and liabilities referred to in Part 1 of the Sixth Schedule |
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Service Charge Period | the period in respect of which the Service Charge is calculated as determined from time to time by the Landlord and notified to the Tenant and initially is each consecutive period of twelve months ending on 31 December | ||
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Sign Display | the panel or panels installed by the Landlord on the Building for the display of name and logo signs the part of the Service Charge for which the Tenant is liable which shall be such fair and | ||
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Tenants Proportion of the Service Charge | proper proportion as the Landlords Surveyor shall from time to time determine acting as an expert | ||
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Winnersh 500 | means that part of the Estate (of which the Premises form part) shown edged blue on the Lease Plan |
2.1 | The expressions the Landlord and the Tenant shall wherever the context so admits include their respective successors in title | |
2.2 | Where the Tenant or the Surety (if any) for the time being are two or more persons the terms the Tenant and the Surety (if any) include the plural number and obligations expressed or implied to be made by such party are deemed to be made by such persons jointly and each of them severally | |
2.3 | Words importing one gender include all other genders and words importing the singular include the plural and vice versa | |
2.4 | References in this Lease to any statute or legislation (whether specific or general) include any other statute or legislation replacing amending or |
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supplementing the same and any orders regulations bye-laws notices permissions approvals or consents thereunder | ||
2.5 | References in the Sixth Schedule to gross external areas mean such areas from time to time. |
3. | DEMISE | |
The Landlord demises to the Tenant the Premises together with the Rights referred to in Part 1 of the Second Schedule but subject to the Exceptions and Reservations referred to in Part 2 of the Second Schedule and to any documents and matters referred to in the Fifth Schedule to hold to the Tenant for the Term starting on the Commencement Date yielding and paying therefor during the Term: |
3.1 | Rent | |
yearly the Rent and all increases arising from any review pursuant to the provisions in this Lease for the review of rent to be paid without any deduction or set off by equal quarterly payments in advance on the Twenty-fifth day of March the Twenty-fourth day of June the Twenty-ninth day of September and the Twenty-fifth day of December in every year the first payment for the period from and including the Rent Commencement Date up to and including the day immediately preceding the quarter day next after the date of this Lease to be made on the date of this Lease | ||
3.2 | Service Charge for the Estate | |
as additional rent the Tenants Proportion of the Service Charge in respect of the Estate in accordance with Part 1 of the Sixth Schedule | ||
3.3 | Winnersh 500 facilities | |
as additional rent the sums payable by the Tenant in respect of Winnersh 500 pursuant to and in accordance with Part 2 of the Sixth Schedule |
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3.4 | Additional Access | |
as additional rent the sums payable by the Tenant in respect of the Additional Access pursuant to and in accordance with Part 3 of the Sixth Schedule | ||
3.5 | Insurance | |
as additional rent from time to time a sum or sums of money equal to the expense incurred by the Landlord in effecting or maintaining insurance in accordance with clause 5.2 (including any increased premium payable in respect of the Premises or any neighbouring property by reason of any act or omission by (or permitted by) the Tenant or an undertenant) as the Landlord shall from time to time effect such insurance for the Landlords benefit in the Full Reinstatement Value against the Insured Risks and the Loss of Rent such sum or sums to be paid on demand |
4. | TENANTS COVENANTS | |
The Tenant covenants with the Landlord as follows: |
4.1 | Payment of rents | |
To pay the respective rents and sums of money reserved and made payable at the times and in the manner in which the same are set out or referred to in clause 3 without any deduction or set off and to make all such payments to the Landlord on the due date through the Tenants bankers by the direct debit system | ||
4.2 | Interest on late payments | |
If the Tenant shall fail to pay any rents or any other sum payable under this Lease when the same is due (whether formally demanded or not) to pay to the Landlord as additional rent (but without prejudice to any other rights of the Landlord including those under clause 6) interest on all such rents or other sums from the due date for payment until the date actually paid |
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at the Prescribed Rate current at such due date and any such interest shall be recoverable by the Landlord as rent in arrear | ||
4.3 | Payment of rates |
4.3.1 | To pay and indemnify the Landlord against all existing and future rates or other outgoings whatsoever imposed or charged upon the Premises or upon the owner or occupier in respect of the Premises | |
4.3.2 | To pay and be responsible for all electricity gas and other services to the Premises |
4.4 | Exterior painting | |
In every third year and in the last year of the Term to prepare and paint the outside of the Building where usually or previously so painted in a good and workmanlike manner and otherwise properly to clean treat or decorate other parts of the outside of the Building as the same ought to be cleaned treated and decorated (such painting and decorating to be carried out in colours and patterns first approved in writing by the Landlord such approval not to be unreasonably withheld or delayed) and whenever necessary to renew or replace all seats and mastics | ||
4.5 | Interior painting | |
In every fifth year and in the last year of the Term to prepare and paint all the interior of the Building where usually or previously so painted in a good and workmanlike manner (all such painting in the last year of the Term to be carried out in colours and patterns first approved in writing by the Landlord) such approval not to be unreasonably withheld or delayed | ||
4.6 | Repair |
4.6.1 | Well and substantially to repair and maintain the Premises and the walls fences roads and Conducting Media in on or under the Premises (damage by any of the Insured Risks excepted unless the |
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insurance moneys are withheld in whole or in part or the policy avoided by reason of any act or omission on the part of the Tenant or any undertenant or any employee contractor or invitee of either of them) and at all times to keep the same in good and substantial repair and condition and so repaired cleaned painted and maintained and further to keep all parts of the Premises clean and tidy and free from rubbish and waste materials | ||
4.6.2 | To keep the Parking Area for and suitable for the parking of vehicles only | |
4.6.3 | Subject to clause 4.6.4 to keep the Landscaped Areas as landscaped areas maintained and planted as laid out and planted by the Landlord and in accordance with any general scheme for the Estate from time to time specified by the Landlord and to replace with equivalent specimens any plants that may die or need replacement and regularly to cut the grass and generally to tend nurture and maintain the Landscaped Areas | |
4.6.4 | If the Landlord so requires at any time or from time to time not to do the things referred to in clause 4.6.3 (or such of them as may be notified to the Tenant) and shall give to the Tenant reasonable notice of such requirement but instead to pay to the Landlord on demand the reasonable and proper costs incurred by the Landlord in doing so or (where the Landlord incurs costs in relation to such Areas and all or any of the other areas shown hatched green on the Lease Plan) a proper proportion (as defined in paragraph 1.2 Part 2 of the Fifth Schedule) of the costs so incurred by the Landlord |
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4.6.5 | Not in any event to harm or damage any of the Landscaped Areas or the landscaping or plants on them nor to alter such Areas or the scheme of landscaping and plants |
4.7 | Yielding Up | |
At the expiration or sooner determination of the Term to yield up the Premises in good and substantial repair and consistent with the full and due compliance by the Tenant with its obligations under this Lease and to remove such tenants trade fixtures and fittings and any signs erected by or at the instance of the Tenant making good any damage caused by such removal | ||
4.8 | Reinstatement |
4.8.1 | Three months before the expiry or sooner determination of the Term (unless or to the extent otherwise required in writing by the Landlord) to carry out such works as shall be necessary or desirable in order to ensure that the Premises or such part or parts of them as may be required by the Landlord conform with the description in the First Schedule | |
4.8.2 | Immediately before the assignment or underletting of this Lease or of the lease of the Adjoining Premises (whether with or without the Landlords consent) separately from the other to carry out all such works as shall be necessary to ensure that the Premises and the Adjoining Premises are rendered separate and to reinstate any party walls and to remove all doors windows or other openings and to seal off any Conducting Media | |
4.8.3 | All such works shall be carried out to the satisfaction of the Landlord and the Tenant shall apply for any necessary planning permission or |
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approval which may be required under the Planning Acts or other legislation |
4.9 | Landlords access | |
On the giving of reasonable prior notice in writing to permit the Landlord or its agents at all times during the Term during reasonable hours in the day (or at any time in the case of emergency) with or without workmen and others to enter the Premises for the purpose of ascertaining that the covenants and conditions of this Lease have been performed and observed by the Tenant and examining (including opening up floors walls and ceilings where necessary to examine) the state of repair and condition of the Premises or for the purpose of taking inventories of the Landlords fixtures or of carrying out works on the adjoining property of the Landlord and of exercising any of the Exceptions and Reservations referred to in Part 2 of the Second Schedule the Landlord causing as little damage and inconvenience as practicable and as soon as practicable making good all damage caused in the exercise of such right | ||
4.10 | Default remedies of the Landlord | |
If within three months after service of a notice from the Landlord requiring the Tenant to remedy any breach of covenant relating to the state of repair or condition of the Premises or otherwise to the carrying out of any works or actions (or earlier in case of emergency) the Tenant shall not have commenced and proceeded diligently and expeditiously such works or actions then to permit the Landlord to enter upon the Premises and execute all or any such works or actions and the Landlords proper costs and expenses (including the Landlords surveyors and other professional fees in connection therewith) together with interest thereon at the Prescribed Rate current at the date one month after service of such notice for the |
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period from that date to the date of payment shall be a debt due from the Tenant to the Landlord and be forthwith recoverable as rent in arrear | ||
4.11 | Signs and aerials | |
Not to erect any pole mast or aerial or erect or display any sign noticeboard or advertisement on any part of the Premises but the Tenant shall install and maintain in the Sign Display an appropriate sign (to the prior written approval of the Landlord not to be unreasonably withheld) showing the name of the Tenant and (if applicable) its logo but showing no other information | ||
4.12 | Use |
4.12.1 | Not to use the Premises or any part thereof otherwise than for the Permitted Use and not at any time to store anything on any part of the Premises outside the Building | |
4.12.2 | To use only for the parking of vehicles the Parking Area (but not to park any trailers on such Area) and to require employees to use only such Area for the parking of their vehicles and to enforce such requirement by all reasonable means available to the Tenant as an employer |
4.13 | Refuse and rubbish |
4.13.1 | To ensure that all refuse rubbish and waste material is put in secure and closed containers designed for that purpose and to take all appropriate measures to prevent escape of refuse rubbish or waste materials from such containers | |
4.13.2 | To make and maintain satisfactory arrangements for the regular removal of all refuse rubbish and waste materials from the Premises so often as is necessary |
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4.13.3 | If the Tenant fails to take immediately such steps as may be necessary to comply with clause 4.13.1 or 4.13.2 after notice from the Landlord requiring it to do so to permit the Landlord or others authorised by it (if the Landlord decides to do so) to enter the Premises to carry out removal of refuse rubbish or waste materials (whether or not on a regular basis) and to pay to the Landlord on demand all proper costs and expenses incurred by the Landlord in connection with any removal arrangements which it makes |
4.14 | Nuisance |
4.14.1 | Not to use the Premises or any part of them for any illegal purpose nor to carry out on or from the Premises any noisy noxious dangerous or offensive act activity or business nor anything which may be or become a nuisance or damage to the Landlord or any of its tenants or the occupiers of any premises in the neighbourhood and in particular not to do or permit to be done anything which might cause electronic or radio interference with any adjoining or neighbouring premises | |
4.14.2 | Not to do anything which would or might lead to any contamination of the Premises or pollution of the environment or lead to the pollution obstruction damaging or overloading of the Conducting Media and to carry out (or at the Landlords election to pay to the Landlord the proper costs and fees of carrying out) all works necessary to remedy the contamination or pollution or to remove the source of the contamination or pollution | |
4.14.3 | Where the Tenant has failed to observe any of the obligations in this clause 4.14 to pay to the Landlord the proper costs incurred by it in obtaining such reports as the Landlord may reasonably require to |
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establish what damage or harm may have been caused to the Premises or other property of the Landlord and the remedial cleaning or other works necessary | ||
4.14.4 | Not to discharge or allow to enter into any underground or other waters any poisonous noxious or harmful effluent liquid or substance |
4.15 | Estate Regulations | |
To observe such reasonable regulations as may from time to time be made by the Landlord for the purposes of good estate management | ||
4.16 | Estate Roads and Accessways etc |
4.16.1 | To take all necessary precautions to prevent damage or excessive wear and tear to or any avoidable obstruction of any of the Estate Roads the Accessways or the Additional Access and to pay to the Landlord on demand all proper costs and expenses of making good any damage (other than normal wear and tear) caused to any of them by the Tenant or any undertenant or any of their respective employees contractors or visitors | |
4.16.2 | In particular not to impede or interfere with the reasonable use of the Additional Access by the occupiers of any other unit on Winnersh 500 entitled to use it | |
4.16.3 | Not to park or permit the parking by the employees or contractors of or visitors to the Tenant of vehicles on any of the Estate Roads or Accessways or the Additional Access or elsewhere on the Estate other than in accordance with clause 4.12.2 |
4.17 | Acts prejudicial to insurance |
4.17.1 | Not to do anything as a result of which any policy of insurance against damage to the Premises or to any neighbouring premises may be prejudiced or payment of the policy moneys may be withheld in |
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whole or in part or whereby the rate of premium in respect of any such insurance may be increased and to give notice to the Landlord forthwith upon the happening of any event which might affect any insurance policy relating to the Premises | ||
4.17.2 | In relation to the insurance effected by the Landlord in respect of the Premises to pay to the Landlord any excess required by the insurers or by the Landlord on demand by the Landlord following any damage or destruction by any Insured Risks where such excess would be applicable to any claim in respect of such damage or destruction |
4.18 | Safeguarding the Premises |
4.18.1 | With respect to fire precautions and safeguarding the Premises against damage by any of the Insured Risks or otherwise to comply with all requirements and recommendations of the insurers of the Premises or the relevant insurance brokers or of the fire brigade or local authority | |
4.18.2 | Not to store or bring on to or allow to remain on the Premises any article substance or liquid of a specially combustible inflammable or explosive nature or which may be a source of contamination PROVIDED that for so long as the Tenant is Azur Environmental Limited the storage on the Premises of reasonable quantities of the items listed in the Seventh Schedule for purposes solely connected with the business of Azur Environmental Limited shall be deemed not to be a breach of this clause | |
4.18.3 | To give written notice to the Landlord upon the occurrence of any contamination of the Premises and also upon the occurrence of any pollution of the environment in breach of any legislative provision caused by any use of or action or activity on the Premises |
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4.19 | Planning Applications | |
Not without the prior written consent of the Landlord (such consent not to be unreasonably withheld or delayed) to make any application for any consent under the Planning Acts | ||
4.20 | Alterations | |
Not to erect or place any new building or structure whatsoever on the Premises (including any temporary or moveable building or structure) and not to make any alteration whether structural or otherwise or any addition to the Premises or to the Building or to any buildings which may be erected on the Premises PROVIDED THAT the Tenant may with the written consent of the Landlord (such consent not to be unreasonably withheld or delayed) erect install or alter internal demountable partitions not affecting the structure of the Building | ||
4.21 | Statutory obligations |
4.21.1 | At the Tenants expense to comply in all respects with the provisions of all statutes and legislation (whether now or subsequently in force) affecting or applicable to the Premises or their use and forthwith to give notice to the Landlord of any notice direction or order made by any local or competent authority | |
4.21.2 | Where required by statute or legislation the Tenant shall maintain a health and safely file for any works carried out to the Premises and shall comply with the Construction (Design and Management) Regulations 1994 in respect thereof and provide to the Landlord upon reasonable request a copy of such file |
4.22 | Alienation |
4.22.1 | Not to charge or mortgage either the whole or any part of the Premises nor to assign underlet share or part with the possession or |
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occupation of any part of the Premises nor to permit any such dealing under a permitted underlease | ||
4.22.2 | Not to hold or occupy the Premises or any part as nominee trustee or agent or otherwise for the benefit of any other person | |
4.22.3 | Not to assign or underlet the whole of the Premises without the prior consent in writing of the Landlord (such consent not to be unreasonably withheld where the provisions hereinafter contained are satisfied) | |
4.22.4 | It is agreed that the Landlord will not be deemed to be unreasonable in withholding consent to a proposed assignment of the whole of the Premises if it is withheld on the ground (and it is the case) that one or more of the circumstances mentioned below exist (whether or not such withholding is solely on such ground or on that ground together with other grounds): |
4.22.4.1 | that in the reasonable opinion of the Landlord the effect of the proposed assignment upon the value of the Landlords reversionary interest in the Premises would be to diminish or otherwise adversely affect such value | |
4.22.4.2 | that in the reasonable opinion of the Landlord the effect of the assignment would mean that there is a reduced likelihood of the tenants covenants and obligations in this Lease being fulfilled | |
4.22.4.3 | that the proposed assignee is an associated company of the Tenant |
4.22.5 | On any assignment:- |
4.22.5.1 | The Tenant will enter into an Authorised Guarantee Agreement which will be in such form as the Landlord may reasonably |
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request and be prepared by or on behalf of the Landlord and at the cost of the Tenant and under which the assignor will agree (inter alia) with the Landlord:- |
4.22.5.1.1.1 | that it is liable as sole or principal debtor in respect of all obligations to be owed by the assignee under the Tenant Covenants (as defined in Section 28 of the Act) in this Lease | |
4.22.5.1.1.2 | to be liable as guarantor in respect of the assignees performance the Tenant Covenants (as above defined) in this Lease (provided that such liability shall be no more onerous than the liability to which the assignor would be subject in the event of his being liable as sole or principal debtor in respect of the obligations owed by the assignee under the said Tenant Covenants) | |
4.22.5.1.1.3 | In the event of this Lease being disclaimed to enter into a new lease of the Premises the term of which shall expire simultaneously with the date upon which (but for any such disclaimer) this Lease would have expired by effluxion of time (and not by any other means) and the Tenant Covenants shall be identical to (mutatis mutandis but in any event no |
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more onerous than) the Tenant Covenants in this Lease |
4.22.5.2 | If the Landlord reasonably so requires the Tenant shall obtain acceptable guarantors for any person to whom this Lease is to be assigned who will covenant with the Landlord on the terms (mutatis mutandis) set out in the Third Schedule | |
4.22.5.3 | If the Landlord reasonably so requires the proposed assignee will prior to the assignment enter into such reasonable rent deposit arrangement and/or provide such additional security for performance by the proposed assignee of its obligations under this Lease as the Landlord may reasonably require | |
4.22.5.4 | The proposed assignee shall enter into a covenant with the Landlord to pay the rents reserved by and perform and observe the covenants on the part of the Tenant contained in this Lease |
4.22.5.4.1 | clauses 4.22.4 and 4.22.5 shall operate without prejudice to the right of the Landlord to impose any further conditions upon a grant of consent where such imposition is reasonable |
4.22.6 | Not to underlet the whole of the Premises without the prior consent in writing of the Landlord otherwise than at a rent which is not less than the open market rental value of the Premises (being in any event not less than the rent then payable under this Lease) without a line or premium and with provision for upwards only rent reviews coinciding with the reviews under this Lease and in other respects with materially the same covenants and conditions as are contained in this Lease |
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4.22.5 | Not to vary the terms of any underlease permitted under this clause 4.22 without the Landlords written consent and throughout the term of any underlease to require the undertenant at all times to perform and observe the Tenants covenants (except as to the payment of rent) and the conditions contained in this Lease | |
4.22.6 | The Landlord may as a condition for giving its consent for any permitted underletting require the proposed underlessee to enter into a direct covenant with the Landlord to perform and observe the Tenants covenants and the conditions contained in this Lease (save as to payment of rent) | |
4.22.7 | Upon the Landlord consenting to an underletting of the Premises procure that the underlessee covenants with the Landlord: |
4.22.7.1 | Not to assign (or agree to do so) any part of the Premises (as distinct from the whole) and not to charge or underlet or share or (save by way of an assignment of the whole) part with possession of or permit any person to occupy the whole or any part of the Premises | |
4.22.7.2 | Not to assign (or agree to do so) the whole of the Premises without the prior consent in writing of the Landlord (such consent not to be unreasonably withheld) |
4.22.8 | To notify the Landlord in writing with relevant details within fourteen days of any rent payable under an underlease being reviewed | |
4.22.9 | In the event that any circumstances or conditions specified in clauses 4.22.4 and 4.22.5 above are framed by reference to any matter falling to be determined by the Landlord (or by any other person) if the Tenant disputes such determination then either the Landlord or the Tenant shall be entitled to require the matter or matters in question |
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to be referred to an independent expert who in the absence of agreement between the parties shall be appointed on the application of either party by the President of the Royal Institution of Chartered Surveyors and the determination of such independent expert shall be conclusive as to the matter or matters in question and shall be final and binding on the parties and his costs shall be met by the parties in such proportions as the independent expert shall determine |
4.23 | Registration of dealings | |
Within one month after the execution of any assignment or underlease permitted under this Lease or any assignment of such underlease or after any devolution by will or otherwise of the Term or after any other dealing with this Lease to supply a certified copy of the deed or instrument effecting the same to the Landlord and to pay such reasonable fee as the Landlord may require for registration | ||
4.24 | Reletting and sale boards | |
To permit the Landlord or its agents to enter upon the Premises and to affix upon any suitable part (which does not obscure the Tenants own signs) a notice board for reletting or selling the same and not to remove or obscure the same and to permit all persons authorised in writing by the Landlord or its agents on the giving of reasonable prior written notice to view the Premises during business hours in the daytime | ||
4.25 | Costs of licences and notices as to breach of covenant | |
To pay on demand and indemnify the Landlord against all costs charges and expenses) (including professional fees) reasonably and properly incurred by the Landlord arising out of or incidental to any application made by the Tenant for any consent or approval of the Landlord and against all costs charges and expenses (including any professional fees) properly incurred |
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by the Landlord arising out of or incidental to any breach of the Tenants covenants or the preparation and service of a schedule or interim schedule of dilapidations or any notice which the Landlord may serve on the Tenant whether served before or after the determination of this Lease (including a notice under Section 146 of the Law of Property Act 1925) requiring the Tenant to remedy any breach of any of its covenants or arising out of or in connection with any proceedings referred to in Sections 146 or 147 of that Act notwithstanding that forfeiture may be avoided otherwise than by relief granted by the Court | ||
4.26 | Indemnity | |
To be responsible for and to indemnify the Landlord against: |
4.26.1 | all damage loss or injury occasioned to the Premises or any adjoining premises or to the Accessways the Additional Access the Landscaped Areas or any Conducting Media or to any person or chattel (whether or not upon the Premises) caused by any act default or negligence of the Tenant or any undertenant or the servants agents licensees or invitees of either of them or by reason of any defect in the Premises and | |
4.26.2 | all losses damages costs expenses claims and proceedings incurred by or made against the Landlord arising out of any breach by the Tenant of any of its obligations arising by virtue of this Lease |
4.27 | VAT | |
To pay to the Landlord upon demand any value added tax chargeable upon: |
4.27.1 | any supply made by the Landlord to the Tenant pursuant to this Lease so that all consideration for any such supply is exclusive of value added tax |
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4.27.2 | any supply (whether made to the Landlord or to a third person) where pursuant to this Lease the Tenant is required to pay to the Landlord any sum in respect of any costs fees expenses or other expenditure or liability (of whatever nature) in connection with that supply except to the extent that any such value added tax may be recoverable by the Landlord from H.M. Customs and Excise |
PROVIDED ALWAYS that the Landlord will produce a valid VAT invoice to the Tenant within 14 days of receipt of any payment of VAT from the Tenant | ||
4.28 | Defects | |
To inform the Landlord as soon as practicable in writing of any defect in the Premises which might give rise to a duty imposed by common law or statute on the Landlord and to indemnify the Landlord against all actions costs claims and liabilities suffered or incurred by or made against the Landlord in respect of the Premises under the Defective Premises Act 1972 | ||
4.29 | Costs of party items | |
In so far as the Tenant is not obliged to contribute to the costs of the same under any other provision of this Lease to pay a fair and proper proportion of the expense (including any professional fees) of repairing rebuilding painting maintaining cleaning and lighting all party structures and all roofs conducting media boundary structures forecourts yards roads ways entrances passages staircases balconies and other amenities or things the use or benefit of which is common to the Premises and any adjoining or neighbouring premises such proportion to be determined by the Landlords Surveyor whose determination shall (save in the case of manifest error) be final and binding on the Tenant |
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4.30 | Documents affecting title | |
To perform and observe the provisions of the documents and the other matters referred to in the Fifth Schedule so far as they affect or relate to the Premises |
5. | LANDLORDS COVENANTS | |
The Landlord covenants with the Tenant: |
5.1 | Quiet enjoyment | |
That the Tenant performing and observing the covenants conditions and agreements contained in this Lease shall and may peaceably and quietly hold and enjoy the Premises during the Term without any lawful interruption or disturbance by the Landlord or any person rightfully claiming through or under it | ||
5.2 | Insurance | |
At all times during the Term to keep the Premises insured for the Landlords benefit in the Full Reinstatement Value against the Insured Risks and if the Premises are damaged or destroyed by any of the Insured Risks the Landlord will with all convenient and practicable speed repair or reinstate the Premises using such materials as are then appropriate subject to all necessary consents and licences being obtained | ||
Provided that: |
5.2.1 | the Landlords obligations under this covenant shall cease if the insurance shall be rendered void or voidable or the policy moneys withheld in whole or in part by reason of any act or default of the Tenant or any undertenant or any of their respective employees contractors licensees or invitees | |
5.2.2 | if the Premises are destroyed or so seriously damaged by any Insured Risk as to require (in the opinion of the Landlords surveyor whose |
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decision shall be final and binding upon the Parties) substantial reconstruction then the Landlord may at any time within six months notice in writing to determine this Lease and immediately upon the expiry of that notice this demise shall determine but without prejudice to the rights and remedies of any party against any other in respect of any antecedent claim or breach of covenant and all insurance money shall be the absolute property of the Landlord |
5.3 | Estate Roads and Parking etc | |
Subject to payment by the Tenant of the Tenants Proportion of the Service Charge in accordance with Part 1 of the Sixth Schedule and any sums payable in accordance with Part 2 of the Sixth Schedule the Landlord shall: |
5.3.1 | maintain and repair such of the Estate Roads as are within the Estate and use all reasonable endeavours to do so (or to procure that it be done) in respect of the remainder of the Estate Roads until (in each case) adoption by the highway authority and | |
5.3.2 | maintain and repair the Accessways and the Additional Access. |
6. | CONDITIONS | |
Provided always and it is hereby agreed and declared as follows: |
6.1 | Re-possession on Tenants default | |
If at any time during the Term: |
6.1.1 | the rents reserved by this Lease or any of them or any part of them shall be in arrear for fourteen days after the same shall have become due (whether legally demanded or not) or | |
6.1.2 | the Tenant shall at any time fail or neglect to perform or observe any of the covenants conditions or agreements on its part to be performed and observed contained in this Lease or in any licence approval or consent given by the Landlord to the Tenant in relation |
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to the Premises or in any other deed supplemental to this Lease or by which this Lease may be varied or | ||
6.1.3 | the Tenant either shall (being a corporation) have an application made for an administration order (whether or not at its instance) or enter into liquidation whether compulsory or voluntary (not being a voluntary liquidation for the purpose of reconstruction only) or (being an individual) become bankrupt or | |
6.1.4 | the Tenant shall make any arrangement or composition with creditors or suffer any distress or execution to be levied on property of the Tenant or have an encumbrancer take possession or a receiver appointed in respect of the same |
then and in any such case it shall be lawful for the Landlord (or any person or persons duly authorised by it in that behalf) to re-enter into or upon the Premises and thereupon the Term shall absolutely cease and determine but without prejudice to the rights and remedies of the Landlord in respect of any antecedent breach of any of the covenants conditions or agreements contained in this Lease | ||
6.2 | Benefit of insurance and abatement of rent |
6.2.1 | The benefit of all insurance effected by the Landlord under this Lease or otherwise in respect of the Premises or the Estate shall belong solely to the Landlord but if the Premises or any part of them shall at any time be destroyed or damaged by any of the Insured Risks so as to be unfit for occupation or use then and in every such case (unless the Landlords policy of insurance in relation to the Premises shall have been rendered void or voidable or the policy moneys withheld in whole or in part by reason of the act default or omission of the Tenant or any undertenant or any of their respective employees |
26
contractors licensees or invitees) the rent first reserved by this Lease or a fair and just proportion thereof according to the nature and extent of the damage sustained shall be suspended and cease to be payable until the Building shall have been repaired or reinstated and made fit for occupation or use in accordance with clause 5.2 | ||
6.2.2 | No account shall be taken of damage in relation to any alteration or improvement to the Premises carried out otherwise than by the Landlord unless such alteration or improvement has in fact been taken into account in effecting both the insurance of the Premises and the insurance in respect of the Loss of Rent | |
6.2.3 | Any dispute between the Landlord and the Tenant concerning the proportion or duration of the suspension or cesser shall be determined by an arbitrator appointed in default of agreement between the Landlord and the Tenant on the application of either of them by the President of the Royal Institution of Chartered Surveyors and any such reference shall be a submission to arbitration within the Arbitration Acts 1950 and 1979 |
6.3 | Notices | |
The provisions of Section 196 Law of Property Act 1925 (as amended) shall apply to the giving and service of all notices and documents under or in connection with this Lease | ||
6.4 | Repair of Estate Roads etc | |
The Landlord shall have no liability to the Tenant: |
6.4.1 | in relation to any failure to maintain and repair the Estate Roads the Accessways or the Additional Access unless the Tenant has given written notice to the Landlord of the relevant aspect of non maintenance or disrepair or |
27
6.4.2 | on the grounds of disrepair of the Estate Roads caused by traffic using the Estate Roads for the purposes of the development of other parts of the Estate or the carrying out of works on the Estate but so that the disrepair shall be made good within a reasonable period after the Estate Roads have ceased to be so used |
6.5 | Closure of facilities | |
Subject to the Landlord using all reasonable endeavours to procure alternative access to the Premises the Landlord may temporarily close or withdraw from use any of the Estate Roads the Accessways or the Additional Access to permit the carrying out of any repairs maintenance or works by it or any person authorised by it and in such circumstances the Tenant shall have no claim against the Landlord in connection with any such closure or withdrawal the person carrying out such works endeavouring to keep such closure or withdrawal to the minimum reasonably required |
7. | RENT REVIEW |
7.1 | In this clause: |
Assumptions | means the assumptions that: | |||||||
|
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|
1. | the Premises are in good and substantial repair and condition | ||||||
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|
2. | the Landlord and the Tenant have complied with all their respective covenants and obligations imposed by this Lease on each of them | ||||||
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3. | all parts of the Premises are fit and ready for use for the Permitted Use |
28
|
4. | that the rent at which the Premises could reasonably be expected to be let is that which would be payable after the expiry of any rent free period or after the receipt of such other rent concession or inducement (in each case for whatever reason) as may be negotiated in the open market between a landlord and a tenant upon a letting of the Premises | ||||||
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5. | no work has been carried out on the Premises during the Term which has diminished the rental value of the Premises and | ||||||
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6. | any damage to or destruction of the Premises or any means of access to them has been fully reinstated | ||||||
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Current Rent | means the yearly rent reserved by this Lease (disregarding any suspension of rent under any other provision of this Lease) as varied from time to time pursuant to this clause | |||||||
|
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Matters to be Disregarded | means each of the following matters so far as they may affect rental value: | |||||||
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1. | the fact that the Tenant has previously been in occupation of the Premises | ||||||
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2. | any goodwill attaching to the Premises by reason of the carrying on of the business of the Tenant at the Premises and |
29
|
3. | any improvement to the Premises carried out during the Term by the Tenant or undertenant other than improvements effected at the expense of the Landlord or pursuant to any obligation to the Landlord whether under the provisions of this Lease or any other deed or document | ||||||
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New Rent |
as at any Review Date means the higher of:
|
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1. | the Current Rent immediately before that Review Date and | ||||||
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2. | the Rental Value as at that Review Date | ||||||
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President |
means the President for the time being of the
Royal Institution of Chartered Surveyors any other body
reasonably specified by the Landlord
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Rental Value |
as at any Review Date means the open market
rental value of the Premises at that Review Date:
|
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1. | as agreed by the Landlord and the Tenant or | ||||||
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2. | as determined by a Valuer pursuant to the provisions of this clause | ||||||
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Valuer | means a chartered surveyor who has experience of practice in property of the nature and type of the Premises and who is acquainted with the market in the area in which the Premises are located |
7.2 | The New Rent shall be payable from and including each Review Date. |
30
7.3 | If the New Rent has not been agreed by the date which is three months before the relevant Review Date either the Landlord or the Tenant may require the Rental Value to be determined by a Valuer | |
7.4 | Where the Rental Value is to be determined by a Valuer and the Landlord and the Tenant do not agree as to his appointment within twenty one days of either of them putting forward a nomination to the other such Valuer shall be appointed at the request of either party by the President | |
7.5 | The Valuer shall act as an expert and not as an arbitrator and his decision (including any decision as to the costs of such determination) shall be final and binding on the parties | |
7.6 | The Valuer shall upon appointment either by the parties or the President be required upon his determination to provide a reasoned award to the Landlord and the Tenant | |
7.7 | Notwithstanding that the Valuer shall act as an expert the Landlord and the Tenant shall each be entitled to make representations and counter-representations to such Valuer a copy of which shall be supplied by the Valuer to the other of them and in making an award as to costs the Valuer shall have regard to the representations and counter-representations made to him | |
7.8 | The Valuer shall determine the Rental Value as the best yearly open market rack rental value at which the Premises might reasonably be expected to be let with vacant possession in the open market by a willing lessor to a willing lessee for a term of years equal in length to the balance unexpired of the Term as at the relevant Review Date and on the terms and conditions of a lease which are otherwise the same as this Lease except as to the actual amount of the Current Rent and the date on which the term commences |
31
and making the Assumptions but taking no account of the Matters to be Disregarded | ||
7.9 | If by the relevant Review Date the New Rent has not been ascertained (whether or not negotiations have commenced) the Tenant shall continue to pay the Current Rent on each day appointed by this Lease for payment of Rent until the New Rent has been ascertained and upon such ascertainment of the New Rent the Tenant will pay to the Landlord as arrears of rent an amount equal to the difference between the New Rent and the Current Rent actually paid for the period since the relevant Review Date together with interest on the difference at 3% below the Prescribed Rate | |
7.10 | In no event shall the yearly rent payable by the Tenant to the Landlord after the relevant Review Date be less than the yearly rent payable by the Tenant to the Landlord immediately before such relevant Review Date | |
7.11 | A memorandum in the form set out in the Fourth Schedule of any increased rent determined pursuant to this clause 7 shall as soon as may be after such determination be prepared in duplicate and signed by or on behalf of the Landlord and Tenant |
8. | TENANTS OPTION TO DETERMINE |
8.1 | In this clause Termination Date means November 2001 or November 2006 | |
8.2 | Subject to the pre-conditions in clause 8.3 being satisfied on the relevant Termination Date, and subject to clause 4.8 the Tenant may determine the Term on a Termination Date by giving the Landlord not less than six months written notice, which notice must be expressed to be given under section 24(2) of the Landlord and Tenant Act 1954. The Term will then determine on the relevant Termination Date, but without prejudice to any |
32
8.3 | The pre-conditions are that: |
8.3.1 | vacant possession of the whole of the Premises is given to the Landlord; and | |
8.3.2 | all rent and other sums due under this Lease up to the relevant Termination Date have been paid in full and all the Tenants obligations in this Lease up to the relevant Termination Date have been substantially complied with |
8.4 | The Landlord may waive any of the pre-conditions set out in clause 8.3 at any time before the relevant Termination Date by written notice to the Tenant | |
8.5 | The Tenant will cancel any registration it has made in connection with this clause within 15 working days of the relevant Termination Date | |
8.6 | Time will be of the essence for the purposes of this clause |
1. | The right in common with the Landlord and all other persons now or at any time after the date of this Lease similarly entitled to pass at all times and for all purposes connected with the proper use of the Premises in accordance with this Lease: |
33
1.1 | with or without vehicles over and along the Estate Roads and the Accessways and (except for that part hatched purple on the Lease Plan) the Additional Access until in each case adoption by the highway authority and | |
1.2 | on foot only over and along that part of the Additional Access shown hatched purple on the Lease Plan |
2. | The right in common with the Landlord and all other persons now or at any subsequent time entitled to a similar right to the free passage and running of water soil gas electricity and other services from and to the Premises through the Conducting Media in the Estate other than those adopted by the relevant statutory undertaker | |
3. | The right of support and protection for the Premises from the remainder of Winnersh 500 | |
4. | So far as necessary and in any event subject to any licence required by clause 4.20 the right to enter upon so much of the area shown hatched green on the Lease Plan as lies to the rear of the Land to install and thereafter at all times to maintain repair renew and rebuild an air conditioning plant |
1. | To the Landlord and all others authorised by it the free and uninterrupted passage and running of water soil gas electricity and telephone or any other service or supply from the other buildings and land of the Landlord and its tenants adjoining or near the Premises and from the land and premises of others so authorised as aforesaid through the Conducting Media which are now or may hereafter be in through under or over the Premises | |
2. | To the Landlord and all others authorised by it the right at all times to enter the Premises with all necessary equipment for the purposes of: |
34
2.1 | carrying any repairs maintenance or works to or in relation to the Accessways and (where clause 4.6.5 applies) the Landscaped Areas including the right to use and take water from any external water supply at the Premises for the purposes of maintenance of planting and landscaping at Winnersh 500 | |
2.2 | laying constructing installing replacing repairing maintaining or altering any Conducting Media now or hereafter in through under or over the Premises or any adjoining property or making connections to any such Conducting Media | |
2.3 | carrying out inspections of or tests to any such Conducting Media | |
2.4 | doing such other things in relation to any Conducting Media which directly or indirectly serve or are connected to other premises as the Landlord considers proper to ensure that such Conducting Media are in good working order and condition and | |
2.5 | exercising any of the rights of the Landlord contained in this Lease. |
The Landlord causing as little damage and inconvenience as practicable in the exercise of such rights and as soon as practicable making good all damage caused |
3. | To the Landlord full right and liberty at any time hereafter or from time to time to execute works and erections upon or to alter or rebuild any of the buildings erected on any part of the Estate and to use its Estate and each part of it in such manner as the Landlord may think fit notwithstanding that the access of light and air to the Premises may thereby be interfered with | |
4. | To the Landlord and other the tenants and occupiers of other parts of Winnersh 500 the right of support and protection from the Premises | |
5. | To the Landlord the right to install and retain on the Land columns for the provision of lighting security or other services for Winnersh 500 and the right to enter the Premises with all necessary equipment for such purposes or for |
35
maintaining altering or replacing such column the Landlord causing as little damage and inconvenience as practicable in the exercise of such rights and as soon as practicable making good all damage caused |
1. | If at any time the Tenant shall not pay any of the rents or other sums payable under this Lease or perform and observe any of the covenants conditions or other terms of the Lease the Surety shall pay such rents or other sums or observe or perform such covenants conditions or other terms | |
2. | By way of separate and additional liability and notwithstanding that the guarantee in paragraph 1 may be unenforceable or invalid for any reason the Surety indemnifies the Landlord against all proper losses damages costs and expenses suffered or incurred by the Landlord arising out of or in connection with any failure by the Tenant to pay any of the rents and sums or to perform and observe any of the covenants conditions or other terms referred to in paragraph 1 | |
3. | If: |
3.1 | the Tenant shall be wound up or (being an individual) become bankrupt and its liquidator or trustee in bankruptcy shall disclaim this Lease or | |
3.2 | the Tenant shall cease to exist or shall die or | |
3.3 | this Lease shall be forfeited | |
(the date on which such event occurs being called the Relevant Date) the Landlord may within three months after the Relevant Date by notice in writing require the Surety to accept a lease of the Premises for a term commencing on the Relevant Date and continuing for the residue then remaining of the Term at the same rents and with the same covenants and conditions as are reserved by and are contained in this Lease and in such case the Surety shall take such lease |
36
accordingly and execute a counterpart of it and pay all costs and duties in relation to it |
4. | The Surety undertakes with the Landlord that: |
4.1 | its obligations to the Landlord are primary obligations and it is jointly and severally liable with the Tenant (both before or after any disclaimer by a liquidator or trustee in bankruptcy) for the fulfillment of all the Tenants covenants and obligations | |
4.2 | the Surety shall not claim in any liquidation bankruptcy administration receivership composition or arrangement of the Tenant in competition with the Landlord and that the Surety shall remit to the Landlord the proceeds of all judgments and all distributions which the Surety may receive from any liquidator trustee in bankruptcy administrator administrative receiver receiver or supervisor of the Tenant and shall hold for the benefit of the Landlord all security and rights the Surety may have over assets of the Tenant while any liabilities of the Tenant or the Surety to the Landlord remain outstanding and | |
4.3 | if the Landlord shall not require the Surety to take a new lease of the Premises the Surety shall nevertheless upon demand pay to the Landlord a sum equal to the rent first reserved under this Lease and all other sums that would have been payable under this Lease in respect of the period from and including the Relevant Date until the expiry of six months after such Date or until the Landlord shall have granted a lease of the Premises to a third party (whichever shall first occur) in addition and without prejudice to the Suretys other obligations to the Landlord |
5. | The Surety waives any right to require the Landlord to proceed against the Tenant or to pursue any other remedy of any kind which may be available to the Landlord before proceeding against the Surety |
37
6. | The liabilities of the Surety under this Schedule shall not be affected by: |
6.1 | the granting of time or any other indulgence or concession to the Tenant or any compromise or compounding of the Landlords rights | |
6.2 | the Tenant being in liquidation or (as the case may be) declared bankrupt | |
6.3 | any variation in the terms and conditions of this Lease | |
6.4 | any delay in exercising or failure to exercise or other exercise (including re-entry under clause 6.1) of any of the Landlords rights against the Tenant | |
6.5 | any refusal by the Landlord to accept rent tendered by or on behalf of the Tenant following a breach by the Tenant of its obligations under this Lease | |
6.6 | any legal limitation or any immunity disability or incapacity of the Tenant (whether or not known to the Landlord) or the fact that any dealings with the Landlord by the Tenant (including the acceptance by the Tenant of this Lease) may be outside or in excess of the powers of the Tenant or | |
6.7 | any other thing (including the expiration or sooner determination of the Term or any such disclaimer or the death of the Surety (or any of the persons comprising the Surety) or (in relation to one or more of such persons) the discharge of the other person or persons) whereby (but for this provision) the Surety or any of them would be exonerated either wholly or in part from any of the Surety obligations hereunder |
38
Dated:
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[ ] | |
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Signed:
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________________ | |
|
Landlord/Tenant |
1. | The covenants matters and stipulations set out or referred to in or contained or referred to in the documents referred to in the Property and Charges Registers of the Landlords title number BK 167503 so far as the same affect or relate to the Premises other than the various agreements under Section 52 of the Town and Country Planning Act 1971 as varied by the Termination Agreement dated 30th June 1993 |
39
2. | A lease dated 5th November 1996 between Slough Properties Limited (1) and Southern Electric plc (2) relating to an electricity substation to the south-east of the Premises |
1. | repairing maintaining cleaning renewing and resurfacing the Estate Roads (including the renewal of the line markings on the Roads) | |
2. | repairing maintaining replacing and operating the lighting of the Estate Roads (including the cost of electricity) | |
3. | repairing maintaining decorating and replacing any estate office for the Estate including: |
3.1 | the cost of services (including electricity gas and telephone) supplied in any such office | |
3.2 | rates payable in respect of any such office | |
3.3 | the cost of equipment and materials in or for such office to the extent that they are intended to be provided for the purposes of such office |
4. | repairing maintaining and renewing any Conducting Media in or for any part of the Estate to the extent that they are not the responsibility of any tenant of the Landlord on the Estate or of a statutory undertaker and do not exclusively serve premises occupied by such a tenant |
40
5. | repairing maintaining cleaning and keeping tidy the Common Areas including the tending care and replacement of plants and trees and the maintenance and upkeep of landscaped areas including nature strips in roads or on roundabouts at or at the approaches to Winnersh Triangle |
6. | repair maintenance and replacement of tanks pumps pipes and other equipment (excluding any that form part of the Premises) forming part of the sprinkler system at the Estate including the costs of inspection and maintenance contracts |
7. | repair maintenance decoration operation lighting and cleaning of any structures fences walls signs footpaths amenities and things on the Common Areas and benefiting the Estate or part of it including any entrance feature from time to time for the Estate and any equipment associated with it |
8. | employing staff for the benefit of the Estate or the provision of any services on or for the Estate (including for the purposes of operating an estate office) including the costs of statutory and other insurance health pension welfare and other payments contributions and premiums and the costs incidental to the performance of the duties of any such staff but where engaged also to perform duties not connected with the Estate only a proportion of each of such costs |
9. | rates taxes assessments duties charges burdens impositions and outgoings imposed or charged upon the Common Areas or any part of them (including any estate office) or upon the owner or occupier thereof |
10. | insurance in such sum and against such risks as the Landlord shall consider appropriate in respect of damage to any part of the Common Areas (including the Estate Roads) and the structures buildings walls fences and other things thereon |
11. | public liability insurance in respect of any liability of the Landlord in relation to the Estate and the Estate Roads |
12. | calculating the Service Charge and the Tenants liability under this Lease including preparation of accounts and certification |
41
13. | providing such security service for the benefit of the Estate as the Landlord may from time to time consider appropriate | |
14. | the management of the Estate including the fees and disbursements of: |
14.1 | any managing agents for or in connection with such management (including the collection of rent and other sums payable by tenants of the Estate to the Landlord but excluding the costs of court proceedings in recovering arrears from tenants other than the Tenant) and the performance of any other duties or services in or about the Estate | |
14.2 | the Landlords Surveyor for or in connection with the performance of any function for the purposes of this Lease | |
14.3 | any other individual firm or company engaged to perform services for the Estate or any part of it | |
14.4 | the Landlord where it carries out any service or function to such management (including a fee charged by the Landlord for the collection of rent and other sums payable by tenants of the Estate to the Landlord but excluding the costs of court proceedings in recovering arrears from tenants other than the Tenant) |
15. | any other facility service amenity or thing provided on or for the Estate and intended to benefit the Estate and in the interests of good estate management |
16. | any value added tax payable on any of the costs referred to in this Part |
1.1 | The Landlord shall as soon as practicable after the end of each Service Charge Period: |
1.1.1 | prepare an account giving particulars of the Service Charge for that Period and showing the Tenants Proportion of the Service Charge and |
42
1.1.2 | supply to the Tenant a copy of such account |
1.2 | Upon such account being certified by the Landlords Surveyor it shall be conclusive evidence for the purposes of this Lease of all matters of fact referred to in it save in respect of manifest error | |
2.1 | Advance payments on account of the Tenants Proportion of the Service Charge in respect of a Service Charge Period shall be paid to the Landlord by the Tenant according to the reasonable and proper estimate made by the Landlords Surveyor acting as expert of the amount of the Service Charge for that Period | |
2.2 | Written notice of such estimate shall be promptly given to the Tenant | |
2.3 | Such payments shall be made by equal instalments on each of the quarter days occurring during the relevant Period or (if the estimate is notified to the Tenant after such a quarter day) on such of them as occur after such notification. | |
2.4 | The first advance payment shall be: |
2.4.1 | in respect of the period from the Commencement Date until the next quarter day after the date of this Lease | |
2.4.2 | paid by the Tenant on the date of this Lease and | |
2.4.3 | calculated according to an estimate of the Service Charge made in accordance with 2.1 and notified in writing to the Tenant |
3. | If the Tenants Proportion of the Service Charge for a Service Charge Period: |
3.1 | exceeds any amounts paid by the Tenant to the Landlord as advance payments on account thereof the amount of the excess (or the whole Proportion if no advance payments have been made) shall (notwithstanding the expiration or sooner determination of the Term) be paid by the Tenant to the Landlord within twenty-one days of the supply to the Tenant of the account pursuant to paragraph 1 or |
43
3.2 | is less than such amounts so paid the amount of the difference shall be credited to the Tenant against the next payments of rents due |
4. | In respect of each of the Service Charge Periods in which occur the Commencement Date and the date of the expiration or sooner determination of the Term the Tenant shall only be obliged to pay the Tenants Proportion of the Service Charge in respect of that part of the Service Charge for that Period as bears to the whole of that Service Charge the same proportion that the number of days of the Term occurring in the relevant Period bears to 365 |
1.1 | The Tenant shall pay to the Landlord on written demand the proper proportion of the costs liabilities fees and expenses which the Landlord incurs or becomes liable to pay in connection with: |
1.1.1 | the Accessways and any signs or direction notices on or for them including all sums incurred pursuant to clause 5.3 or otherwise in the maintenance repair cleaning lighting renewal and resurfacing of them and | |
1.1.2 | the maintenance of landscaping at Winnersh 500 so far as not demised to any tenant |
1.2 | In this paragraph 1 the proper proportion means (subject to clause 6.8) a fair proportion (which may take into account the extent and nature of use) to be certified by the Landlords Surveyor whose decision shall be final and binding on the parties |
2.1 | The Tenant shall pay to the Landlord on written demand the proper proportion of the costs liabilities fees and expenses which the Landlord |
44
incurs or becomes liable to pay in connection with the provision and maintenance of any other facility service amenity or thing for the benefit or use of the tenants or occupiers of and in Winnersh 500 | ||
2.2 | In this paragraph 2 the proper proportion means (subject to Clause 6.8) the proportion which the gross external area of the Building bears to the aggregate of that area and the gross external area of the other buildings at Winnersh 500 (or any buildings replacing such buildings) |
1. | The Tenant shall pay to the Landlord on written demand the proper proportion of the costs liabilities fees and expenses which the Landlord incurs or becomes liable to pay in connection with: |
1.1 | repairing maintaining cleaning renewing and resurfacing the Additional Access or | |
1.2 | repairing maintaining replacing and operating any lighting of the Additional Access |
2. | In this Part 3 the proper proportion means (subject to clause 6.8) the proportion which the gross external area of the Building bears to the aggregate of that area and the gross external area of Building 535 |
45
46
Production Area
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364.96 m 2 | (3,928 sq.ft.) | ||
First Floor Office
|
185.41m 2 | (1,996 sq. ft.) | ||
Ground Floor Office
|
185.41 m 2 | (1,996 sq. ft) | ||
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Total
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735.78 m 2 | (7,920 sq. ft) |
Page 1
South:
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- | Car parking in concrete block paving for five cars. | ||
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- | Landscaping incorporating shrubs and semi mature trees. | ||
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- | Block paving footpaths. | ||
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East:
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- | 2.4m high x 200mm diameter painted mild steel tubular bollards with cranked tops to loading door reveals. | ||
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- | Two retractable anti ram bollards to loading bay door. | ||
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- | Remote landscaping incorporating shrubs and semi mature trees. | ||
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- | Car parking in concrete block paving for fourteen cars. |
Page 2
Ground Floor:
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2 No. | WC suites. | ||
Male
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2 No. | Hand basins. | ||
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2 No. | Urinals. | ||
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Ground Floor: Female
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2 No. | WC suites. | ||
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2 No. | Hand basins. | ||
Tea Room:
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1 No. | Stainless steel single bowl, single drainer sink set in post formed melamine worktop with base units under. | ||
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Ground Floor:
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1 No. | WC suite. | ||
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1 No. | Hand basin. | ||
Disabled Toilet
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3 No. | Fixed grab rails. | ||
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1 No. | Retractable grab rail. | ||
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First Floor:
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1 No. | WC suite. | ||
Male Toilet
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1 No. | Hand basin. | ||
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1 No. | Urinal. | ||
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First Floor:
|
1 No. | WC suite. |
Page 3
Female Toilet
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1 No. | Hand basin. |
Page 4
Ground Floor Toilet
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5 No. | Recessed compact fluorescent downlights. | ||
Accommodation
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Concealed fluorescent batten luminaires above mirrors and WCs. | |||
Kitchenette & Lobby:
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2 No. | Circular recessed fluorescent fittings with prism louvres. | ||
|
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Production Area:
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9 No. | Sodium boxed downlighters. | ||
|
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Disabled Toilets:
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1 No. | Shallow dome, wall mounted fluorescent fitting. | ||
|
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Staircase &
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4 No. | Recessed, compact, fluorescent downlights. | ||
Associated Lobbies:
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3 No. | Wall mounted, feature, fluorescent fittings. | ||
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3 No. | Recessed, circular, fluorescent luminaires. | ||
|
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First Floor Toilet
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3 No. | Compact fluorescent downlights | ||
Accommodation:
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2 No. | Concealed fluorescent batten luminaires above WCs. | ||
|
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First Floor Office:
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22 No. | 1200mm x 600mm recessed fluorescent luminaires with V cross blade low brightness louvres. | ||
|
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External:
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3 No. | Compact fluorescent downlights to canopy over entrance. Tungsten floodlight over rear loading bay door. |
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1 No. | 400 A load switch (main incomer) | ||
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1 No. | Dorman Smith switchgear load bank distribution board provided with two 100A switches, a 32A switch for external lighting, two 25A switches for fire alarm supply and heating and ventilation control equipment. |
Page 5
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1 No. | Lighting and power distribution board for offices. | ||
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1 No. | Distribution board for production area lighting and power. | ||
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1 No. | External lighting DB stop and control panel. | ||
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1 No. | Lighting contactors panel. |
Page 6
Page 7
DATED | 27th September | 2001 |
(1) | AZUR ENVIRONMENTAL LIMITED (Company Registration no 2538199) whose registered office is at 540/545 Eskdale Road Winnersh Triangle Wokingham Berkshire RG41 5TU (the Assignor); | |
(2) | MICROSCIENCE LIMITED (Company Registration no 03270465) whose registered office is at 545 Eskdale Road Winnersh Triangle Wokingham RG41 5TU (the Assignee) |
(1) | Lease or underlease | |
By a lease particulars of which are set out in the first schedule (the Lease) the property more particularly described in the Lease the postal address of which is set out in the second schedule (the Property) was demised to the Assignor for the term of years and at the yearly rent set out in the first schedule subject to the performance and observance of the covenants on the part of the Assignor and the conditions contained in the Lease and subject to and with the benefit of the document particulars of which are set out in the Third Schedule (the documents). | ||
(2) | Agreement for sale | |
The Assignor has agreed with the Assignee in consideration of the covenant on the part of the Assignee contained below for the assignment to the Assignee of the Property for the residue of the term granted by the Lease subject to and with the benefit of the documents. |
1. | Assignment | |
In pursuance of the above agreement and in consideration of the covenant on the part of the Assignee contained below the Assignor with full title guarantee assigns to the Assignee ALL THAT the Property TO HOLD the Property to the Assignee for the residue now unexpired of the term of years granted by the Lease SUBJECT henceforth to the payment of the rent reserved by and the performance and observance of the covenants and agreements on the part of the lessee and the conditions contained in the Lease and the documents. | ||
2. | Covenant for indemnity | |
The Assignee covenants with the Assignor that it and its successors in title to the Property will during the continuance of the term granted by the Lease |
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pay the rent reserved by and perform and observe covenants conditions restrictions stipulations and other matters contained or referred to in the Lease and the documents and will keep the Assignor indemnified against all proceedings costs claims and expenses whatsoever on account of any omission to pay the rent reserved by or any breach of any of the covenants agreements and conditions contained in the Lease and in the documents. | ||
3. | Covenants for title | |
It is hereby agreed and declared between the Assignor and the Assignee that the covenants implied by section 4 of the Law of Property (Miscellaneous Provisions) Act 1994 shall be varied so that the Assignor shall be under no liability for any failure to carry out any works of repair renewal or decoration to the Property or for any other works required under the lease when ever those works are due to be carried out. | ||
4. | Rights of public record | |
It is further agreed and declared between the Assignor and the Assignee that for the purposes of section 6(2) Law of Property (Miscellaneous Provisions) Act 1994, all matters now recorded in registers open to public inspection are to be considered with in the actual knowledge of the Assignee. | ||
5. | Contracts (Rights of Third Parties) Act 1999 | |
It is not intended that any term of this deed shall be enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999. | ||
6. | Certificate of value | |
It is hereby certified that the transaction hereby effected does not form part of a larger transaction or of a series of transactions in respect of which the amount or value of the aggregate amount or value of the consideration exceeds the sum of £60,000. |
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Date
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Document | Parties | ||
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13 December 1996
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Licence for Alterations | Slough Estates Limited (1) | ||
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and the Assignor (2) |
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EXECUTED as a deed by
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AZUR ENVIRONMENTAL LIMITED
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Acting by two directors or a director
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and the company secretary
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Director /s/ [Illegible] | |||||
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Secretary /s/ [Illegible] | |||||
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For and on behalf of | |||||
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MAWLAW SECRETARIES LTD | |||||
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EXECUTED as a deed by
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MICROSCIENCE LIMITED
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) | |||||
Acting by two directors or a director
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and the company secretary
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Director /s/ [Illegible] | |||||
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Director/Secretary /s/ Jonathan RHH Pockson |
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:
13
th
December 1996
:
SLOUGH PROPERTIES LIMITED
:
234 Bath Road Slough SL1 4EE
:
448911
:
AZUR ENVIRONMENTAL LIMITED
:
The Coach House 24A Tile House Street Hitchin Hertfordshire SG5 2DY
:
2538199
:
None
:
the area from time to time comprising
the Landlords estate at Winnersh
Triangle Wokingham of which the Premises
form part the present such area being
shown for identification only edged red
on the Estate Plan
:
the land off Eskdale Road on the Estate shown edged red on the Lease Plan
:
the building (presently known as Winnersh
545) on the Land which (with the Fixtures
and any car parking and landscaping
facilities) is described in the First
Schedule
:
25
th
November 1996
:
20 years together with the period of any
continuation or extension of the tenancy
granted by this Lease
:
25
th
November 1996
:
until 25
th
May 1997 the sum of
£47,916 per annum and thereafter £95,832
per annum subject to review as provided in
this Lease
:
25
th
November 2001 and each
fifth anniversary of that date
:
use for any purpose within Classes B1 and
B8 of the Schedule to the Town and Country
Planning (Use Classes) Order 1987 (as
amended or replaced from time to time)
CLAUSE
SUBJECT
DEFINITIONS
INTERPRETATION
DEMISE
TENANTS COVENANTS
Payment of rents
Interest on late payments
Payment of rates etc
Exterior painting
Interior painting
Repair
Yielding up
Reinstatement
Landlords access
Default remedies of the Landlord
Signs and aerials
Use
Refuse and rubbish
Nuisance
Estate regulations
Estate Roads and Accessways etc
Acts prejudicial to insurance
Safeguarding the Premises
Planning Applications
Alterations
Statutory obligations
CLAUSE
SUBJECT
Alienation
Registration of dealings
Reletting and sale boards
Cost of licences and notices as to breach of covenant
Indemnity
VAT
Defects
Costs of party items
Documents affecting title
LANDLORDS COVENANTS
Quiet enjoyment
Insurance
Estate Roads and Parking etc
CONDITIONS
Repossession on Tenants default
Benefit of insurance and abatement of rent
Notices
Repair of Estate Roads etc
Closure of facilities
RENT REVIEW
TENANTS OPTION TO DETERMINE
SURETY
Building
Part 1
Rights
Part 2
Exceptions and Reservations
Obligations of the Surety
Rent review memorandum
Documents and matters affecting title
Part 1
Service Charge for the Estate
Part 2
Costs or Winnersh 500 facilities
Materials referred to in clause 4.18.2
1. | DEFINITIONS | |
In this Lease the following expressions have the meanings indicated: |
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Accessways | the roads and ways shown for the purpose of identification only hatched brown on the Lease Plan | ||
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the Act | means the Landlord and Tenant (Covenants) Act 1995 | ||
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Adjoining Premises | the premises known as Winnersh 540 demised by a lease of even date made between the Landlord and the Tenant | ||
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Authorised Guarantee Agreement | the meaning defined in and for the purposes of Section 16 of the Act and the form of such Agreement shall be as reasonably required by the Landlord | ||
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Common Areas | the Estate other than the Premises and other areas let or intended by the Landlord to be let but including the whole of the Estate Roads | ||
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Conducting Media | all sewers drains pipes wires watercourses subways cables apparatus conduits and any other media or works for the conduct or transmission of any service matter or material (including any media and works in respect of the sprinkler system at the Estate) | ||
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Estate Plan | the plan marked Estate Plan attached to this Lease |
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Estate Roads |
1. the roads pavements and paths shown for the
purpose of identification only hatched brown on
the Estate Plan (or any road pavement or path
at any time replacing any of them) and
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2. such other roads pavements and paths at
Winnersh Triangle (whether or not on or forming
part of the Estate) as may from time to time
serve or be available for use generally by
tenants and occupiers in connection with
premises on the Estate but excluding any that
may be or become any public highway or footpath
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First Schedule | the schedule referred to in the First Schedule including any amended or substituted schedule describing any other building (and its fixtures equipment and other items) erected on the Land by the Landlord pursuant to this Lease | ||
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Fixtures | the Landlords fixtures from time to time on or forming part of the Land including the fixtures equipment and items which with the Building are described in the First Schedule | ||
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Full Reinstatement Value | the costs (including demolition professional fees and any value added tax payable) which would be likely to be incurred in carrying out repair or reinstatement in accordance with the requirements of this Lease at the time when such |
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repair or reinstatement is likely to take place having regard to current building techniques and materials | |||
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Insured Risks | fire lightning earthquake explosion aircraft riot storm tempest flood burst pipes malicious damage and impact damage and such other insurable risks and on such terms and subject to such exclusions as the Landlord may from time to time consider reasonably necessary but excluding any risks which the Landlord shall decide from time to time not to include in any policy (whether on the grounds of unavailability of insurance cover for that risk or otherwise) but so that the Landlord shall give at least fourteen days prior notice in writing to the Tenant of any risk ceasing to be covered by any policy | ||
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Landscaped Areas | those parts of the Land as are hatched green on the Lease Plan | ||
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Lease Plan | the plan marked Lease Plan attached to this Lease | ||
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Loss of Rent | the loss of the rent first reserved by clause 3 for such period (being not less than three years) as may reasonably be required by the Landlord from time to time having regard to the likely period required for reinstatement in the event of both partial and total destruction and in an amount |
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which would take into account potential increases of rent in accordance with clause 7 | |||
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Parking Area | such area or areas within the Land as are designated for parking and shown on the Lease Plan as demised car parking | ||
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Planning Acts | includes the Town and Country Planning Act 1990 the Planning (Listed Buildings and Conservation Areas) Act 1990 the Planning (Hazardous Substances) Act 1990 and the Planning (Consequential Provisions) Act 1990 | ||
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Premises | the Land together with the Building (or any other building erected by the Landlord in its place) and all additions and the Fixtures and a reference to the Premises includes a reference to any part | ||
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Prescribed Rate | three per centum above the Base Rate of National Westminster Bank PLC from time to time (or such other clearing bank as the Landlord shall nominate) or (if such rate shall cease to be published) such other reasonable or comparable rate as the Landlord shall from time to time designate | ||
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Service Charge | the aggregate of the costs and liabilities referred to in Part 1 of the Sixth Schedule | ||
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Service Charge Period | the period in respect of which the Service Charge is calculated as determined from time to time by the Landlord and notified to the Tenant and |
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initially is each consecutive period of twelve months ending on 31 December | |||
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Sign Display | the panel or panels installed by the Landlord on the Building for the display of name and logo signs | ||
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Tenants Proportion of the Service Charge | the part of the Service Charge for which the Tenant is liable which shall be such fair and proper proportion as the Landlords Surveyor shall from time to time determine acting as an expert | ||
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Winnersh 500 | means that part of the Estate (of which the Premises form part) shown edged blue on the Lease Plan |
2. INTERPRETATION |
2.1 | The expressions the Landlord and the Tenant shall wherever the context so admits include their respective successors in title | |
2.2 | Where the Tenant or the Surety (if any) for the time being are two or more persons the terms the Tenant and the Surety (if any) include the plural number and obligations expressed or implied to be made by such party are deemed to be made by such persons jointly and each of them severally | |
2.3 | Words importing one gender include all other genders and words importing the singular include the plural and vice versa | |
2.4 | References in this Lease to any statute or legislation (whether specific or general) include any other statute or legislation replacing amending or supplementing the same and any orders regulations bye-laws notices permissions approvals or consents thereunder |
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2.5 | References in the Sixth Schedule to gross external areas mean such areas from time to time |
3. | DEMISE | |
The Landlord demises to the Tenant the Premises together with the Rights referred to in Part 1 of the Second Schedule but subject to the Exceptions and Reservations referred to in Part 2 of the Second Schedule and to any documents and matters referred to in the Fifth Schedule to hold to the Tenant for the Term starting on the Commencement Date yielding and paying therefor during the Term: |
3.1 | Rent | |
yearly the Rent and all increases arising from any review pursuant to the provisions in this Lease for the review of rent to be paid without any deduction or set off by equal quarterly payments in advance on the Twenty-fifth day of March the Twenty-fourth day of June the Twenty-ninth day of September and the Twenty-fifth day of December in every year the first payment for the period from and including the Rent Commencement Date up to and including the day immediately preceding the quarter day next after the date of this Lease to be made on the date of this Lease | ||
3.2 | Service Charge for the Estate | |
as additional rent the Tenants Proportion of the Service Charge in respect of the Estate in accordance with Part 1 of the Sixth Schedule | ||
3.3 | Winnersh 500 facilities | |
as additional rent the sums payable by the Tenant in respect of Winnersh 500 pursuant to and in accordance with Part 2 of the Sixth Schedule | ||
3.4 | Insurance | |
as additional rent from time to time a sum or sums of money equal to the expense incurred by the Landlord in effecting or maintaining insurance in accordance with clause 5.2 (including any increased premium payable in |
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respect of the Premises or any neighbouring property by reason of any act or omission by (or permitted by) the Tenant or an undertenant) as the Landlord shall from time to time effect such insurance for the Landlords benefit in the Full Reinstatement Value against the Insured Risks and the Loss of Rent such sum or sums to be paid on demand |
4. | TENANTS COVENANTS | |
The Tenant covenants with the Landlord as follows: |
4.1 | Payment of rents | |
To pay the respective rents and sums of money reserved and made payable at the times and in the manner in which the same are set out or referred to in clause 3 without any deduction or set off and to make all such payments to the Landlord on the due date through the Tenants bankers by the direct debit system | ||
4.2 | Interest on late payments | |
If the Tenant shall fail to pay any rents or any other sum payable under this Lease when the same is due (whether formally demanded or not) to pay to the Landlord as additional rent (but without prejudice to any other rights of the Landlord including those under clause 6) interest on all such rents or other sums from the due date for payment until the date actually paid at the Prescribed Rate current at such due date and any such interest shall be recoverable by the Landlord as rent in arrear | ||
4.3 | Payment of rates etc |
4.3.1 | To pay and indemnify the Landlord against all existing and future rates or other outgoings whatsoever imposed or charged upon the Premises or upon the owner or occupier in respect of the Premises | |
4.3.2 | To pay and be responsible for all electricity gas and other services to the Premises |
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4.4 | Exterior painting | |
In every third year and in the last year of the Term to prepare and paint the outside of the Building where usually or previously so painted in a good and workmanlike manner and otherwise properly to clean treat or decorate other parts of the outside of the Building as the same ought to be cleaned treated and decorated (such painting and decorating to be carried out in colours and patterns first approved in writing by the Landlord such approval not to be unreasonably withheld or delayed) and whenever necessary to renew or replace all seals and mastics | ||
4.5 | Interior painting | |
In every fifth year and in the last year of the Term to prepare and paint all the interior of the Building where usually or previously so painted in a good and workmanlike manner (all such painting in the last year of the Term to be carried out in colours and patterns first approved in writing by the Landlord) such approval not to be unreasonably withheld or delayed | ||
4.6 | Repair |
4.6.1 | Well and substantially to repair and maintain the Premises and the walls fences roads and Conducting Media in on or under the Premises (damage by any of the Insured Risks excepted unless the insurance moneys are withheld in whole or in part or the policy avoided by reason of any act or omission on the part of the Tenant or any undertenant or any employee contractor or invitee of either of them) and at all times to keep the same in good and substantial repair and condition and so repaired cleaned painted and maintained and further to keep all parts of the Premises clean and tidy and free from rubbish and waste materials |
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4.6.2 | To keep the Parking Area for and suitable for the parking of vehicles only | |
4.6.3 | Subject to clause 4.6.4 to keep the Landscaped Areas as landscaped areas maintained and planted as laid out and planted by the Landlord and in accordance with any general scheme for the Estate from time to time specified by the Landlord and to replace with equivalent specimens any plants that may die or need replacement and regularly to cut the grass and generally to tend nurture and maintain the Landscaped Areas | |
4.6.4 | If the Landlord so requires at any time or from time to time not to do the things referred to in clause 4.6.3 (or such of them as may be notified to the Tenant) and shall give to the Tenant reasonable notice of such requirement but instead to pay to the Landlord on demand the reasonable and proper costs incurred by the Landlord in doing so or (where the Landlord incurs costs in relation to such Areas and all or any of the other areas shown hatched green on the Lease Plan) a proper proportion (as defined in paragraph 1.2 Part 2 of the Fifth Schedule) of the costs so incurred by the Landlord | |
4.6.5 | Not in any event to harm or damage any of the Landscaped Areas or the landscaping or plants on them nor to alter such Areas or the scheme of landscaping and plants |
4.7 | Yielding up | |
At the expiration or sooner determination of the Term to yield up the Premises in good and substantial repair and consistent with the full and due compliance by the Tenant with its obligations under this Lease and to remove such tenants trade fixtures and fittings and any signs erected by or |
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at the instance of the Tenant making good any damage caused by such removal | ||
4.8 | Reinstatement |
4.8.1 | Three months before the expiry or sooner determination of the Term (unless or to the extent otherwise required in writing by the Landlord) to carry out such works as shall be necessary or desirable in order to ensure that the Premises or such part or parts of them as may be required by the Landlord conform with the description in the First Schedule | |
4.8.2 | Immediately before the assignment or underletting of this Lease or of the lease of the Adjoining Premises (whether with or without the Landlords consent) separately from the other to carry out all such works as shall be necessary to ensure that the Premises and the Adjoining Premises are rendered separate and to reinstate any party walls and to remove all doors windows or other openings and to seal off any Conducting Media | |
4.8.3 | All such works shall be carried out to the satisfaction of the Landlord and the Tenant shall apply for any necessary planning permission or approval which may be required under the Planning Acts or other legislation |
4.9 | Landlords access | |
On the giving of reasonable prior notice in writing to permit the Landlord or its agents at all times during the Term during reasonable hours in the day (or at any time in the case of emergency) with or without workmen and others to enter the Premises for the purpose of ascertaining that the covenants and conditions of this Lease have been performed and observed by the Tenant and examining (including opening up floors walls and ceilings |
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where necessary to examine) the state of repair and condition of the Premises or for the purpose of taking inventories of the Landlords fixtures or of carrying out works on the adjoining property of the Landlord and of exercising any of the Exceptions and Reservations referred to in Part 2 of the Second Schedule the Landlord causing as little damage and inconvenience as practicable and as soon as practicable making good all damage caused in the exercise of such right | ||
4.10 | Default remedies of the Landlord | |
If within three months after service of a notice from the Landlord requiring the Tenant to remedy any breach of covenant relating to the state of repair or condition of the Premises or otherwise to the carrying out of any works or actions (or earlier in case of emergency) the Tenant shall not have commenced and proceeded diligently and expeditiously such works or actions then to permit the Landlord to enter upon the Premises and execute all or any such works or actions and the Landlords proper costs and expenses (including the Landlords surveyors and other professional fees in connection therewith) together with interest thereon at the Prescribed Rate current at the date one month after service of such notice for the period from that date to the date of payment shall be a debt due from the Tenant to the Landlord and be forthwith recoverable as rent in arrear | ||
4.11 | Signs and aerials | |
Not to erect any pole mast or aerial or erect or display any sign noticeboard or advertisement on any part of the Premises but the Tenant shall install and maintain in the Sign Display an appropriate sign (to the prior written approval of the Landlord not to be unreasonably withheld) showing the name of the Tenant and (if applicable) its logo but showing no other information |
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4.12 | Use |
4.12.1 | Not to use the Premises or any part thereof otherwise than for the Permitted Use and not at any time to store anything on any part of the Premises outside the Building | |
4.12.2 | To use only for the parking of vehicles the Parking Area (but not to park any trailers on such Area) and to require employees to use only such Area for the parking of their vehicles and to enforce such requirement by all reasonable means available to the Tenant as an employer |
4.13 | Refuse and rubbish |
4.13.1 | To ensure that all refuse rubbish and waste material is put in secure and closed containers designed for that purpose and to take all appropriate measures to prevent escape of refuse rubbish or waste materials from such containers | |
4.13.2 | To make and maintain satisfactory arrangements for the regular removal of all refuse rubbish and waste materials from the Premises so often as is necessary | |
4.13.3 | If the Tenant fails to take immediately such steps as may be necessary to comply with clause 4.13.1 or 4.13.2 after notice from the Landlord requiring it to do so to permit the Landlord or others authorised by it (if the Landlord decides to do so) to enter the Premises to carry out removal of refuse rubbish or waste materials (whether or not on a regular basis) and to pay to the Landlord on demand all proper costs and expenses incurred by the Landlord in connection with any removal arrangements which it makes |
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4.14 | Nuisance |
4.14.1 | Not to use the Premises or any part of them for any illegal purpose nor to carry out on or from the Premises any noisy noxious dangerous or offensive act activity or business nor anything which may be or become a nuisance or damage to the Landlord or any of its tenants or the occupiers of any premises in the neighbourhood and in particular not to do or permit to be done anything which might cause electronic or radio interference with any adjoining or neighbouring premises | |
4.14.2 | Not to do anything which would or might lead to any contamination of the Premises or pollution of the environment or lead to the pollution obstruction damaging or overloading of the Conducting Media and to carry out (or at the Landlords election to pay to the Landlord the proper costs and fees of carrying out) all works necessary to remedy the contamination or pollution or to remove the source of the contamination or pollution | |
4.14.3 | Where the Tenant has failed to observe any of the obligations in this clause 4.14 to pay to the Landlord the proper costs incurred by it in obtaining such reports as the Landlord may reasonably require to establish what damage or harm may have been caused to the Premises or other property of the Landlord and the remedial cleaning or other works necessary | |
4.14.4 | Not to discharge or allow to enter into any underground or other waters any poisonous noxious or harmful effluent liquid or substance |
4.15 | Estate regulations | |
To observe such reasonable regulations as may from time to time be made by the Landlord for the purposes of good estate management |
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4.16 | Estate Roads and Accessways etc |
4.16.1 | To take all necessary precautions to prevent damage or excessive wear and tear to or any avoidable obstruction or any of the Estate Roads or the Accessways and to pay to the Landlord on demand all proper costs and expenses of making good any damage (other than normal wear and tear) caused to any of them by the Tenant or any undertenant or any of their respective employees contractors or visitors | |
4.16.2 | Not to park or permit the parking by the employees or contractors of or visitors to the Tenant of vehicles on any of the Estate Roads or Accessways or elsewhere on the Estate other than in accordance with clause 4.12.2 |
4.17 | Acts prejudicial to insurance |
4.17.1 | Not to do anything as a result of which any policy of insurance against damage to the Premises or to any neighbouring premises may be prejudiced or payment of the policy moneys may be withheld in whole or in part or whereby the rate of premium in respect of any such insurance may be increased and to give notice to the Landlord forthwith upon the happening of any event which might affect any insurance policy relating to the Premises | |
4.17.2 | In relation to the insurance effected by the Landlord in respect of the Premises to pay to the Landlord any excess required by the insurers or by the Landlord on demand by the Landlord following any damage or destruction by any Insured Risks where such excess would be applicable to any claim in respect of such damage or destruction |
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4.18 | Safeguarding the Premises |
4.18.1 | With respect to fire precautions and safeguarding the Premises against damage by any of the Insured Risks or otherwise to comply with all requirements and recommendations of the insurers of the Premises or the relevant insurance brokers or of the fire brigade or local authority | |
4.18.2 | Not to store or bring on to or allow to remain on the Premises any article substance or liquid of a specially combustible inflammable or explosive nature or which may be a source of contamination PROVIDED that for so long as the Tenant is Azur Environmental Limited the storage on the Premises of reasonable quantities of the items listed in the Seventh Schedule for purposes solely connected with the business of Azur Environmental Limited shall be deemed not to be a breach of this clause | |
4.18.3 | To give written notice to the Landlord upon the occurrence of any contamination of the Premises and also upon the occurrence of any pollution of the environment in breach of any legislative provision caused by any use of or action or activity on the Premises |
4.19 | Planning Applications | |
Not without the prior written consent of the Landlord (such consent not to be unreasonably withheld or delayed) to make any application for any consent under the Planning Acts | ||
4.20 | Alterations | |
Not to erect or place any new building or structure whatsoever on the Premises (including any temporary or moveable building or structure) and not to make any alteration whether structural or otherwise or any addition to the Premises or to the Building or to any buildings which may be erected |
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on the Premises PROVIDED THAT the Tenant may with the written consent of the Landlord (such consent not to be unreasonably withheld or delayed) erect install or alter internal demountable partitions not affecting the structure of the Building |
4.21 | Statutory obligations |
4.21.1 | At the Tenants expense to comply in all respects with the provisions of all statutes and legislation (whether now or subsequently in force) affecting or applicable to the Premises or their use and forthwith to give notice to the Landlord of any notice direction or order made by any local or competent authority | |
4.21.2 | Where required by statute or legislation the Tenant shall maintain a health and safety file for any works carried out to the Premises and shall comply with the Construction (Design and Management) Regulations 1994 in respect thereof and provide to the Landlord upon reasonable request a copy of such file |
4.22 | Alienation |
4.22.1 | Not to charge or mortgage either the whole or any part of the Premises nor to assign underlet share or part with the possession or occupation of any part of the Premises nor to permit any such dealing under a permitted underlease | |
4.22.2 | Not to hold or occupy the Premises or any part as nominee trustee or agent or otherwise for the benefit of any other person | |
4.22.3 | Not to assign or underlet the whole of the Premises without the prior consent in writing of the Landlord (such consent not to be unreasonably withheld where the provisions hereinafter contained are satisfied) |
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4.22.4 | It is agreed that the Landlord will not be deemed to be unreasonable in withholding consent to a proposed assignment of the whole of the Premises if it is withheld on the ground (and it is the case) that one or more of the circumstances mentioned below exist (whether or not such withholding is solely on such ground or on that ground together with other grounds):- |
4.22.4.1 | that in the reasonable opinion of the Landlord the effect of the proposed assignment upon the value of the Landlords reversionary interest in the Premises would be to diminish or otherwise adversely affect such value | |
4.22.4.2 | that in the reasonable opinion of the Landlord the effect or the assignment would mean that there is a reduced likelihood of the tenants covenants and obligations in this Lease being fulfilled | |
4.22.4.3 | that the proposed assignee is an associated company of the Tenant |
4.22.5 | On any assignment:- |
4.22.5.1 | The Tenant will enter into an Authorised Guarantee Agreement which will be in such form as the Landlord may reasonably request and be prepared by or on behalf of the Landlord and at the cost of the Tenant and under which the assignor will agree (inter alia) with the Landlord:- |
4.22.5.1.1.1 | that it is liable as sole or principal debtor in respect of all obligations to be owed by the assignee under the Tenant Covenants (as defined in Section 28 of the Act) in this Lease |
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4.22.5.1.1.2 | to be liable as guarantor in respect of the assignees performance of the Tenant Covenants (as above defined) in this Lease (provided that such liability shall be no more onerous than the liability to which the assignor would be subject in the event of his being liable as sole or principal debtor in respect of the obligations owed by the assignee under the said Tenant Covenants) | |
4.22.5.1.1.3 | in the event of this Lease being disclaimed to enter into a new lease of the Premises the term of which shall expire simultaneously with the date upon which (but for any such disclaimer) this Lease would have expired by effluxion of time (and not by any other means) and the Tenant Covenants shall be identical to (mutatis mutandis but in any event no more onerous than) the Tenant Covenants in this Lease |
4.22.5.2 | If the Landlord reasonably so requires the Tenant shall obtain acceptable guarantors for any person to whom this Lease is to be assigned who will covenant with the Landlord on the terms (mutatis mutandis) set out in the Third Schedule | |
4.22.5.3 | If the Landlord reasonably so requires the proposed assignee will prior to the assignment enter into such reasonable rent |
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deposit arrangement and/or provide such additional security for performance by the proposed assignee of its obligations under this Lease as the Landlord may reasonably require | ||
4.22.5.4 | The proposed assignee shall enter into a covenant with the Landlord to pay the rents reserved by and perform and observe the covenants on the part of the Tenant contained in this Lease |
4.22.5.4.1 | clauses 4.22.4 and 4.22.5 shall operate without prejudice to the right of the Landlord to impose any further conditions upon a grant of consent where such imposition is reasonable |
4.22.6 | Not to underlet the whole of the Premises without the prior consent in writing of the Landlord otherwise than at a rent which is not less than the open market rental value of the Premises (being in any event not less than the rent then payable under this Lease) without a fine or premium and with provision for upwards only rent reviews coinciding with the reviews under this Lease and in other respects with materially the same covenants and conditions as are contained in this Lease | |
4.22.5 | Not to vary the terms of any underlease permitted under this clause 4.22 without the Landlords written consent and throughout the term of any underlease to require the undertenant at all times to perform and observe the Tenants covenants (except as to the payment of rent) and the conditions contained in this Lease | |
4.22.6 | The Landlord may as a condition for giving its consent for any permitted underletting require the proposed underlessee to enter into a direct covenant with the Landlord to perform and observe the |
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Tenants covenants and the conditions contained in this Lease (save as to payment of rent) | ||
4.22.7 | Upon the Landlord consenting to an underletting of the Premises procure that the underlessee covenants with the Landlord: |
4.22.7.1 | Not to assign (or agree to do so) any part of the Premises (as distinct from the whole) and not to charge or underlet or share or (save by way of an assignment of the whole) part with possession of or permit any person to occupy the whole or any part of the Premises | |
4.22.7.2 | Not to assign (or agree to do so) the whole of the Premises without the prior consent in writing of the Landlord (such consent not to be unreasonably withheld) |
4.22.8 | To notify the Landlord in writing with relevant details within fourteen days of any rent payable under an underlease being reviewed | |
4.22.9 | In the event that any circumstances or conditions specified in clauses 4.22.4 and 4.22.5 above are framed by reference to any matter falling to be determined by the Landlord (or by any other person) if the Tenant disputes such determination then either the Landlord or the Tenant shall be entitled to require the matter or matters in question to be referred to an independent expert who in the absence of agreement between the parties shall be appointed on the application of either party by the President of the Royal Institution of Chartered Surveyors and the determination of such independent expert shall be conclusive as to the matter or matters in question and shall be final and binding on the parties and his costs shall be met by the parties in such proportions as the independent expert shall determine |
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4.23 | Registration of dealings | |
Within one month after the execution of any assignment or underlease permitted under this Lease or any assignment of such underlease or after any devolution by will or otherwise of the Term or after any other dealing with this Lease to supply a certified copy of the deed or instrument effecting the same to the Landlord and to pay such reasonable fee as the Landlord may require for registration | ||
4.24 | Reletting and sale boards | |
To permit the Landlord or its agents to enter upon the Premises and to affix upon any suitable part (which does not obscure the Tenants own signs) a notice board for reletting or selling the same and not to remove or obscure the same and to permit all persons authorised in writing by the Landlord or its agents on the giving of reasonable prior written notice to view the Premises during business hours in the daytime | ||
4.25 | Cost of licences and notices as to breach of covenant | |
To pay on demand and indemnify the Landlord against all costs charges and expenses (including professional fees) reasonably and properly incurred by the Landlord arising out of or incidental to any application made by the Tenant for any consent or approval of the Landlord and against all costs charges and expenses (including any professional fees) properly incurred by the Landlord arising out of or incidental to any breach or the Tenants covenants or the preparation and service of a schedule or interim schedule of dilapidations or any notice which the Landlord may serve on the Tenant whether served before or after the determination of this Lease (including a notice under Section 146 of the Law of Property Act 1925) requiring the Tenant to remedy any breach of any of its covenants or arising out of or in connection with any proceedings referred to in Sections 146 or 147 of that |
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Act notwithstanding that forfeiture may be avoided otherwise than by relief granted by the Court | ||
4.26 | Indemnity | |
To be responsible for and to indemnify the Landlord against: |
4.26.1 | all damage loss or injury occasioned to the Premises or any adjoining premises or to the Accessways or the Landscaped Areas or any Conducting Media or to any person or chattel (whether or not upon the Premises) caused by any act default or negligence of the Tenant or any undertenant or the servants agents licensees or invitees of either of them or by reason of any defect in the Premises and | |
4.26.2 | all losses damages costs expenses claims and proceedings incurred by or made against the Landlord arising out of any breach by the Tenant of any of its obligations arising by virtue of this Lease |
4.27 | VAT | |
To pay to the Landlord upon demand any value added tax chargeable upon: |
4.27.1 | any supply made by the Landlord to the Tenant pursuant to this Lease so that all consideration for any such supply is exclusive of value added tax | |
4.27.2 | any supply (whether made to the Landlord or to a third person) where pursuant to this Lease the Tenant is required to pay to the Landlord any sum in respect of any costs fees expenses or other expenditure or liability (of whatever nature) in connection with that supply except to the extent that any such value added tax may be recoverable by the Landlord from H.M. Customs and Excise |
PROVIDED ALWAYS that the Landlord will produce a valid VAT invoice to the Tenant within 14 days of receipt of any payment of VAT from the Tenant |
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4.28 | Defects | |
To inform the Landlord as soon as practicable in writing of any defect in the Premises which might give rise to a duty imposed by common law or statute on the Landlord and to indemnify the Landlord against all actions costs claims and liabilities suffered or incurred by or made against the Landlord in respect of the Premises under the Defective Premises Act 1972 | ||
4.29 | Costs of party items | |
In so far as the Tenant is not obliged to contribute to the costs of the same under any other provision of this Lease to pay a fair and proper proportion of the expense (including any professional fees) of repairing rebuilding painting maintaining cleaning and lighting all party structures and all roofs conducting media boundary structures forecourts yards roads ways entrances passages staircases balconies and other amenities or things the use or benefit of which is common to the Premises and any adjoining or neighbouring premises such proportion to be determined by the Landlords Surveyor whose determination shall (save in the case of manifest error) be final and binding on the Tenant | ||
4.30 | Documents affecting title | |
To perform and observe the provisions of the documents and the other matters referred to in the Fifth Schedule so far as they affect or relate to the Premises |
5. | LANDLORDS COVENANTS | |
The Landlord covenants with the Tenant: |
5.1 | Quiet enjoyment | |
That the Tenant performing and observing the covenants conditions and agreements contained in this Lease shall and may peaceably and quietly hold and enjoy the Premises during the Term without any lawful |
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interruption or disturbance by the Landlord or any person rightfully claiming through or under it | ||
5.2 | Insurance | |
At all times during the Term to keep the Premises insured for the Landlords benefit
in the Full Reinstatement Value against the Insured Risks and if the Premises are
damaged or destroyed by any of the Insured Risks the Landlord will with all
convenient and practicable speed repair or reinstate the Premises using such
materials as are then appropriate subject to all necessary consents and licences
being obtained
Provided that: |
5.2.1 | the Landlords obligations under this covenant shall cease if the insurance shall be rendered void or voidable or the policy moneys withheld in whole or in part by reason of any act or default of the Tenant or any undertenant or any of their respective employees contractors licensees or invitees | |
5.2.2 | if the Premises are destroyed or seriously damaged by any Insured Risk as to require (to the opinion of the Landlords surveyor whose decision shall be final and binding upon the Parties) substantial reconstruction then the Landlord may at any time within six months notice in writing to determine this Lease and immediately upon the expiry of that notice this demise shall determine but without prejudice to the rights and remedies of any party against any other in respect of any antecedent claim or breach of covenant and all insurance money shall be the absolute property of the Landlord |
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5.3 | Estate Roads and Parking etc | |
Subject to payment by the Tenant of the Tenants Proportion of the Service Charge in accordance with Part 1 of the Sixth Schedule and any sums payable in accordance with Part 2 of the Sixth Schedule the Landlord shall: |
5.3.1 | maintain and repair such of the Estate Roads as are within the Estate and use all reasonable endeavours to do so (or to procure that it be done) in respect of the remainder of the Estate Roads until (in each case) adoption by the highway authority and | |
5.3.2 | maintain and repair the Accessways |
6. | CONDITIONS | |
Provided always and it is hereby agreed and declared as follows: |
6.1 | Repossession on Tenants default | |
If at any time during the Term: |
6.1.1 | the rents reserved by this Lease or any of them or any part of them shall be in arrear for fourteen days after the same shall have become due (whether legally demanded or not) or | |
6.1.2 | the Tenant shall at any time fail or neglect to perform or observe any of the covenants conditions or agreements on its part to be performed and observed contained in this Lease or in any licence approval or consent given by the Landlord to the Tenant in relation to the Premises or in any other deed supplemental to this Lease or by which this Lease may be varied or | |
6.1.3 | the Tenant either shall (being a corporation) have an application made for an administration order (whether or not at its instance) or enter into liquidation whether compulsory or voluntary (not being a voluntary liquidation for the purpose of reconstruction only) or (being an individual) become bankrupt or |
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6.1.4 | the Tenant shall make any arrangement or composition with creditors or suffer any distress or execution to be levied on property of the Tenant or have an encumbrancer take possession or a receiver appointed in respect of the same |
then and in any such case it shall be lawful for the Landlord or any person or persons duly authorised by it in that behalf) to re-enter into or upon the Premises and thereupon the Term shall absolutely cease and determine but without prejudice to the rights and remedies of the Landlord in respect of any antecedent breach of any of the covenants conditions or agreements contained in this Lease | ||
6.2 | Benefit of insurance and abatement of rent |
6.2.1 | The benefit of all insurance effected by the Landlord under this Lease or otherwise in respect of the Premises or the Estate shall belong solely to the Landlord but if the Premises or any part of them shall at any time be destroyed or damaged by any of the Insured Risks so as to be unfit for occupation or use then and in every such case (unless the Landlords policy of insurance in relation to the Premises shall have been rendered void or voidable or the policy moneys withheld in whole or in part by reason of the act default or omission of the Tenant or any undertenant or any of their respective employees contractors licensees or invitees) the rent first reserved by this Lease or a fair and just proportion thereof according to the nature and extent of the damage sustained shall be suspended and cease to be payable until the Building shall have been repaired or reinstated and made fit for occupation or use in accordance with clause 5.2 | |
6.2.2 | No account shall be taken of damage in relation to any alteration or improvement to the Premises carried out otherwise than by the |
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Landlord unless such alteration or improvement has in fact been taken into account in effecting both the insurance of the Premises and the insurance in respect of the Loss of Rent | ||
6.2.3 | Any dispute between the Landlord and the Tenant concerning the proportion or duration of the suspension or cesser shall be determined by an arbitrator appointed in default of agreement between the Landlord and the Tenant on the application of either of them by the President of the Royal Institution of Chartered Surveyors and any such reference shall be a submission to arbitration within the Arbitration Acts 1950 and 1979 |
6.3 | Notices | |
The provisions of Section 196 Law of Property Act 1925 (as amended) shall apply to the giving and service of all notices and documents under or in connection with this Lease | ||
6.4 | Repair of Estate Roads etc |
The Landlord shall have no liability to the Tenant: | ||
6.4.1 | in relation to any failure to maintain and repair the Estate Roads or the Accessways unless the Tenant has given written notice to the Landlord of the relevant aspect of non maintenance or disrepair or | |
6.4.2 | on the grounds of disrepair of the Estate Roads caused by traffic using the Estate Roads for the purposes of the development of other parts of the Estate or the carrying out of works on the Estate but so that the disrepair shall be made good within a reasonable period after the Estate Roads have ceased to be so used |
6.5 | Closure of facilities | |
Subject to the Landlord using all reasonable endeavours to procure alternative access to the Premises the Landlord may temporarily close or |
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withdraw from use any of the Estate Roads the Accessways to permit the carrying out of any repairs maintenance or works by it or any person authorised by if and in such circumstances the Tenant shall have no claim against the Landlord in connection with any such closure or withdrawal the person carrying out such works endeavouring to keep such closure or withdrawal to the minimum reasonably required |
7. | RENT REVIEW |
7.1 | In this clause: |
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Assumptions | means the assumptions that: | ||
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1. the Premises are in good and substantial repair and
condition
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2. the Landlord and the Tenant have complied with all their
respective covenants and obligations imposed by this Lease
on each of them
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3. all parts of the Premises are fit and ready for use for
the Permitted Use
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4. that the rent at which the Premises could reasonably be
expected to be let is that which would be payable after the
expiry of any rent free period or after the receipt of such
other rent concession or inducement (in each case for
whatever reason) as may be negotiated in the open market
between a landlord and a tenant upon a letting of the
Premises
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1. the Current Rent immediately before that Review Date and | |||
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2. the Rental Value as at that Review Date | |||
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President | means the President for the time being of the Royal Institution of Chartered Surveyors any other body reasonably specified by the Landlord | ||
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Rental Value | as at any Review Date means the open market rental value of the Premises at that Review Date: | ||
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1. as agreed by the Landlord and the Tenant or | |||
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2. as determined by a Valuer pursuant to the provisions of this clause | |||
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Valuer | means a chartered surveyor who has experience of practice in property of the nature and type of the Premises and who is acquainted with the market in the area in which the Premises are located |
7.2 | The New Rent shall be payable from and including each Review Date. | |
7.3 | If the New Rent has not been agreed by the date which is three months before the relevant Review Date either the Landlord or the Tenant may require the Rental Value to be determined by a Valuer | |
7.4 | Where the Rental Value is to be determined by a Valuer and the Landlord and the Tenant do not agree as to his appointment within twenty one days of either of them putting forward a nomination to the other such Valuer shall be appointed at the request of either party by the President |
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7.5 | The Valuer shall act as an expert and not as an arbitrator and his decision (including any decision as to the costs of such determination) shall be final and binding on the parties | |
7.6 | The Valuer shall upon appointment either by the parties or the President be required upon his determination to provide a reasoned award to the Landlord and the Tenant | |
7.7 | Notwithstanding that the Valuer shall act as an expert the Landlord and the Tenant shall each be entitled to make representations and counter-representations to such Valuer a copy of which shall be supplied by the Valuer to the other of them and in making an award as to costs the Valuer shall have regard to the representations and counter-representations made to him | |
7.8 | The Valuer shall determine the Rental Value as the best yearly open market rack rental value at which the Premises might reasonably be expected to be let with vacant possession in the open market by a willing lessor to a willing lessee for a term of years equal in length to the balance unexpired of the Term as at the relevant Review Date and on the terms and conditions of a lease which are otherwise the same as this Lease except as to the actual amount of the Current Rent and the date on which the term commences and making the Assumptions but taking no account of the Matters to be Disregarded | |
7.9 | If by the relevant Review Date the New Rent has not been ascertained (whether or not negotiations have commenced) the Tenant shall continue to pay the Current Rent on each day appointed by this Lease for payment of Rent until the New Rent has been ascertained and upon such ascertainment of the New Rent the Tenant will pay to the Landlord as arrears of rent an amount equal to the difference between the New Rent and |
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the Current Rent actually paid for the period since the relevant Review Date together with interest on the difference at 3% below the Prescribed Rate | ||
7.10 | In no event shall the yearly rent payable by the Tenant to the Landlord after the relevant Review Date be less than the yearly rent payable by the Tenant to the Landlord immediately before such relevant Review Date | |
7.11 | A memorandum in the form set out in the Fourth Schedule of any increased rent determined pursuant to this clause 7 shall as soon as may be after such determination be prepared in duplicate and signed by or on behalf of the Landlord and Tenant |
8. | TENANTS OPTION TO DETERMINE |
8.1 | In this clause Termination Date means November 2001 or November 2006 | |
8.2 | Subject to the pre-conditions in clause 8.3 being satisfied on the relevant Termination Date, and subject to clause 4.8 the Tenant may determine the Term on a Termination Date by giving the Landlord not less than six months written notice, which notice must be expressed to be given under section 24(2) of the Landlord and Tenant Act 1954. The Term will then determine on the relevant Termination Date, but without prejudice to any rights of either party against the other for any antecedent breach of its obligations under this Lease | |
8.3 | The pre-conditions are that: |
8.3.1 | vacant possession of the whole of the Premises is given to the Landlord; and | |
8.3.2 | all rent and other sums due under this Lease up to the relevant Termination Date have been paid in full and all the Tenants obligations in this Lease up to the Termination Date have been substantially complied with |
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8.4 | The Landlord may waive any of the pre-conditions set out in clause 8.3 at any time before the relevant Termination Date by written notice to the Tenant | |
8.5 | The Tenant will cancel any registration it has made in connection with this clause within 15 working days of the relevant Termination Date | |
8.6 |
Time will be of the essence for the purposes of this clause
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1. | The right in common with the Landlord and all other persons now or at any time after the date of this Lease similarly entitled to pass at all times and for all purposes connected with the proper use of the Premises in accordance with this Lease: |
1.1 | with or without vehicles over and along the Estate Roads and the Accessways and (except for that part hatched purple on the Lease Plan) until in each case adoption by the highway authority and | |
1.2 | on foot only over and along that part shown hatched purple on the Lease Plan |
2. | The right in common with the Landlord and all other persons now or at any subsequent time entitled to a similar right to the free passage and running of water soil gas electricity and other services from and to the Premises through the |
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Conducting Media in the Estate other than those adopted by the relevant statutory undertaker | ||
3. | The right of support and protection for the Premises from the remainder of Winnersh 500 | |
4. | So far as necessary and in any event subject to any licence required by clause 4.20 the right to enter upon so much of the area shown hatched green on the Lease Plan as lies to the rear of the Land to install and thereafter at all times to maintain repair renew and rebuild an air conditioning plant |
1. | To the Landlord and all others authorised by it the free and uninterrupted passage and running of water soil gas electricity and telephone or any other service or supply from the other buildings and land of the Landlord and its tenants adjoining or near the Premises and from the land and premises of others so authorised as aforesaid through the Conducting Media which are now or may hereafter be in through under or over the Premises | |
2. | To the Landlord and all others authorised by it the right at all times to enter the Premises with all necessary equipment for the purposes of: |
2.1 | carrying any repairs maintenance or works to or in relation to the Accessways and (where clause 4.6.5 applies) the Landscaped Areas including the right to use and take water from any external water supply at the Premises for the purposes of maintenance of planting and landscaping at Winnersh 500 | |
2.2 | laying constructing installing replacing repairing maintaining or altering any Conducting Media now or hereafter in through under or over the Premises or any adjoining property or making connections to any such Conducting Media |
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2.3 | carrying out inspections of or tests to any such Conducting Media | |
2.4 | doing such other things in relation to any Conducting Media which directly or indirectly serve or are connected to other premises as the Landlord considers proper to ensure that such Conducting Media are in good working order and condition and | |
2.5 | exercising any of the rights of the Landlord contained in this Lease. | |
The Landlord causing as little damage and inconvenience as practicable in the exercise of such rights and as soon as practicable making good all damage caused |
3. | To the Landlord full right and liberty at any time hereafter or from time to time to execute works and erections upon or to alter or rebuild any of the buildings erected on any part of the Estate and to use its Estate and each part of it in such manner as the Landlord may think fit notwithstanding that the access of light and air to the Premises may thereby be interfered with | |
4. | To the Landlord and other the tenants and occupiers of other parts of Winnersh 500 the right of support and protection from the Premises | |
5. | To the Landlord the right to install and retain on the Land columns for the provision of lighting security or other services for Winnersh 500 and the right to enter the Premises with all necessary equipment for such purposes or for maintaining altering or replacing such column the Landlord causing as little damage and inconvenience as practicable in the exercise of such rights and as soon as practicable making good all damage caused |
1. | If at any time the Tenant shall not pay any of the rents or other sums payable under this Lease or perform and observe any of the covenants conditions or other |
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terms of the Lease the Surety shall pay such rents or other sums or observe or perform such covenants conditions or other terms | ||
2. | By way of separate and additional liability and notwithstanding that the guarantee in paragraph 1 may be unenforceable or invalid for any reason the Surety indemnifies the Landlord against all proper losses damages costs and expenses suffered or incurred by the Landlord arising out of or in connection with any failure by the Tenant to pay any of the rents and sums or to perform and observe any of the covenants conditions or other terms referred to in paragraph 1 | |
3. | If: |
3.1 | the Tenant shall be wound up or (being an individual) become bankrupt and its liquidator or trustee in bankruptcy shall disclaim this Lease or | |
3.2 | the Tenant shall cease to exist or shall die or 3.3 this Lease shall be forfeited |
(the date on which such event occurs being called the Relevant Date) the Landlord may within three months after the Relevant Date by notice in writing require the Surety to accept a lease of the Premises for a term commencing on the Relevant Date and continuing for the residue then remaining of the Term at the same rents and with the same covenants and conditions as are reserved by and are contained in this Lease and in such case the Surety shall take such lease accordingly and execute a counterpart of it and pay all costs and duties in relation to it | ||
4. | The Surety undertakes with the Landlord that: |
4.1 | its obligations to the Landlord are primary obligations and it is jointly and severally liable with the Tenant (both before or after any disclaimer by a liquidator or trustee in bankruptcy) for the fulfillment of all the Tenants covenants and obligations |
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4.2 | the Surety shall not claim in any liquidation bankruptcy administration receivership composition or arrangement of the Tenant in competition with the Landlord and that the Surety shall remit to the Landlord the proceeds of all judgments and all distributions which the Surety may receive from any liquidator trustee in bankruptcy administrator administrative receiver receiver or supervisor of the Tenant and shall hold for the benefit of the Landlord all security and rights the Surety may have over assets of the Tenant while any liabilities of the Tenant or the Surety to the Landlord remain outstanding and | |
4.3 | if the Landlord shall not require the Surety to take a new lease of the Premises the Surety shall nevertheless upon demand pay to the Landlord a sum equal to the rent first reserved under this Lease and all other sums that would have been payable under this Lease in respect of the period from and including the Relevant Date until the expiry of six months after such Date or until the Landlord shall have granted a lease of the Premises to a third party (whichever shall first occur) in addition and without prejudice to the Suretys other obligations to the Landlord |
5. | The Surety waives any right to require the Landlord to proceed against the Tenant or to pursue any other remedy of any kind which may be available to the Landlord before proceeding against the Surety |
6. | The liabilities of the Surety under this Schedule shall not be affected by: |
6.1 | the granting of time or any other indulgence or concession to the Tenant or any compromise or compounding of the Landlords rights | |
6.2 | the Tenant being in liquidation or (as the case may be) declared bankrupt | |
6.3 | any variation in the terms and conditions of this Lease |
6.4 | any refusal by the Landlord to accept rent tendered by or on behalf of the Tenant following a breach by the Tenant of its obligations under this Lease |
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6.5 | any legal limitation or any immunity disability or incapacity of the Tenant (whether or not known to the Landlord) or the fact that any dealings with the Landlord by the Tenant (including the acceptance by the Tenant of this Lease) may be outside or in excess of the powers of the Tenant or | |
6.6 | any other thing (including the expiration or sooner determination of the Term or any such disclaimer or the death of the Surety (or any of the persons comprising the Surety) or (in relation to one or more of such persons) the discharge of the other person or persons) whereby (but for this provision) the Surety or any of them would be exonerated either wholly or in part from any of the Surety obligations hereunder |
Dated:
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Signed:
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Landlord/Tenant |
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1. | The covenants matters and stipulations set out or referred to in or contained or referred to in the documents referred to in the Property and Charges Registers of the Landlords title number BK 167503 so far as the same affect or relate to the Premises other than the various agreements under Section 52 of the Town and Country Planning Act 1971 as varied by the Termination Agreement dated 30th June 1993 | |
2. | A lease dated 5th November 1996 between Slough Properties Limited (1) and Southern Electric plc (2) relating to an electricity substation to the south-east of the Premises |
1. | repairing maintaining cleaning renewing and resurfacing the Estate Roads (including the renewal of the line markings on the Roads) | |
2. | repairing maintaining replacing and operating the lighting of the Estate Roads (including the cost of electricity) | |
3. | repairing maintaining decorating and replacing any estate office for the Estate including: |
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3.1 | the cost of services (including electricity gas and telephone) supplied to any such office |
3.2 | rates payable in respect of any such office |
3.3 | the cost of equipment and materials in or for such office to the extent that they are intended to be provided for the purposes of such office |
4. | repairing maintaining and renewing any Conducting Media in or for any part of the Estate to the extent that they are not the responsibility of any tenant of the Landlord on the Estate or of a statutory undertaker and do not exclusively serve premises occupied by such a tenant | |
5. | repairing maintaining cleaning and keeping tidy the Common Areas including the tending care and replacement of plants and trees and the maintenance and upkeep of landscaped areas including nature strips in roads or on roundabouts at or at the approaches to Winnersh Triangle | |
6. | repair maintenance and replacement of tanks pumps pipes and other equipment (excluding any that form part of the Premises) forming part of the sprinkler system at the Estate including the costs of inspection and maintenance contracts | |
7. | repair maintenance decoration operation lighting and cleaning of any structures fences walls signs footpaths amenities and things on the Common Areas and benefiting the Estate or part of it including any entrance feature from time to time for the Estate and any equipment associated with it | |
8. | employing staff for the benefit of the Estate or the provision of any services on or for the Estate (including for the purposes of operating an estate office) including the costs of statutory and other insurance health pension welfare and other payments contributions and premiums and the costs incidental to the performance of the duties of any such staff but where engaged also to perform duties not connected with the Estate only a proportion of each of such costs |
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9. | rates taxes assessments duties charges burdens impositions and outgoings imposed or charged upon the Common Areas or any part of them (including any estate office) or upon the owner or occupier thereof |
10. | insurance in such sum and against such risks as the Landlord shall consider appropriate in respect of damage to any part of the Common Areas (including the Estate Roads) and the structures buildings walls fences and other things thereon |
11. | public liability insurance in respect of any liability of the Landlord in relation to the Estate and the Estate Roads |
12. | calculating the Service Charge and the Tenants liability under this Lease including preparation of accounts and certification |
13. | providing such security service for the benefit of the Estate as the Landlord may from time to time consider appropriate |
14. | the management of the Estate including the fees and disbursements of: |
14.1 | any managing agents for or in connection with such management (including the collection of rent and other sums payable by tenants of the Estate to the Landlord but excluding the costs of court proceedings in recovering arrears from tenants other than the Tenant) and the performance of any other duties or services in or about the Estate |
14.2 | the Landlords Surveyor for or in connection with the performance of any function for the purposes of this Lease | |
14.3 | any other individual firm or company engaged to perform services for the Estate or any part of it | |
14.4 | the Landlord where it carries out any service or function in such management (including a fee charged by the Landlord for the collection of rent and other sums payable by tenants of the Estate to the Landlord but excluding the costs of court proceedings in recovering arrears from tenants other than the Tenant) |
41
2.4.2 | paid by the Tenant on the date of this Lease and |
2.4.3 | calculated according to an estimate of the Service Charge made in accordance with 2.1 and notified in writing to the Tenant |
3. | If the Tenants Proportion of the Service Charge for a Service Charge Period: |
3.1 | exceeds any amounts paid by the Tenant to the Landlord as advance payments on account thereof the amount of the excess (or the whole Proportion if no advance payments have been made) shall (notwithstanding the expiration or sooner determination of the Term) be paid by the Tenant to the Landlord within twenty-one days of the supply to the Tenant of the account pursuant to paragraph 1 or | |
3.2 | is less than such amounts so paid the amount of the difference shall be credited to the Tenant against the next payments of rents due |
4. | In respect of each of the Service Charge Periods in which occur the Commencement Date and the date of the expiration or sooner determination of the Term the Tenant shall only be obliged to pay the Tenants Proportion of the Service Charge in respect of that part of the Service Charge for that Period as bears to the whole of that Service Charge the same proportion that the number of days of the Term occurring in the relevant Period bears to 365 |
1.1 | The Tenant shall pay to the Landlord on written demand the proper proportion of the costs liabilities fees and expenses which the Landlord incurs or becomes liable to pay in connection with: |
1.1.1 | the Accessways and any signs or direction notices on or for them including all sums incurred pursuant to clause 5.3 or otherwise in |
42
THE COMMON SEAL of SLOUGH
|
) | |||||
PROPERTIES LIMITED was
|
) | |||||
affixed to this deed in the
|
) | |||||
presence of:
|
) | [S E A L] |
43
Production Area
|
364.96 m 2 | (3,928 sq.ft) | ||
First Floor Office
|
185.41 m 2 | (1,996 sq. ft.) | ||
Ground Floor Office
|
185.41 m 2 | (1,996 sq. ft) | ||
Total
|
735.78 m 2 | (7,920 sq. ft) |
Page 1
South:
|
- | Car parking in concrete block paving for five cars. | ||
|
- | Landscaping incorporating shrubs and semi mature trees. | ||
|
- | Block paving footpaths. | ||
|
||||
West:
|
- | 2.4m high x 200mm diameter painted mild steel tubular bollards with cranked tops to loading door reveals. | ||
|
- | Two retractable anti ram bollards to loading bay door. | ||
|
- | Remote landscaping incorporating shrubs and semi mature trees. | ||
|
- | Car parking in concrete block paving for fifteen cars. |
Page 2
Ground Floor: Male
|
2 No. | WC suites. | ||
|
2 No. | Hand basins. | ||
|
2 No. | Urinals. | ||
|
||||
Ground Floor: Female
|
2 No. | WC suites. | ||
|
2 No. | Hand basins. | ||
|
||||
Tea Room:
|
1 No. | Stainless steel single bowl, single drainer sink set in post formed melamine worktop with base units under. | ||
|
||||
Ground Floor: Disabled Toilet
|
1 No. | WC suite. | ||
|
1 No. | Hand basin. | ||
|
3 No. | Fixed grab rails. | ||
|
1 No. | Retractable grab rail. | ||
|
||||
First Floor: Male Toilet
|
1 No. | WC suite. | ||
|
1 No. | Hand basin. | ||
|
1 No. | Urinal. | ||
|
||||
First Floor:
|
1 No. | WC suite. |
Page 3
Female Toilet
|
1 No. | Hand basin. |
Ground Floor Office:
|
19 No. | Recessed fluorescent luminaires (1200mm x 600mm). |
Page 4
Ground Floor Toilet
|
5 No. | Recessed compact fluorescent downlights. | ||
Accommodation
Kitchenette & Lobby: |
Concealed fluorescent batten luminaires above mirrors and WCs. | |||
|
2 No. | Circular recessed fluorescent fittings with prism louvres. | ||
|
||||
Production Area:
|
9 No. | Sodium boxed downlighters. | ||
|
||||
Disabled Toilets:
|
1 No. | Shallow dome, wall mounted fluorescent fitting. | ||
|
||||
Staircase &
|
4 No. | Recessed, compact, fluorescent downlights. | ||
Associated Lobbies:
|
3 No. | Wall mounted, feature, fluorescent fittings. | ||
|
3 No. | Recessed, circular, fluorescent luminaires. | ||
|
||||
First Floor Toilet
|
3 No. | Compact fluorescent downlights | ||
Accommodation:
|
2 No. | Concealed fluorescent batten luminaires above WCs. | ||
|
||||
First Floor Office:
|
22 No. | 1200mm x 600mm recessed fluorescent luminaires with V cross blade low brightness louvres. | ||
|
||||
External:
|
3 No. | Compact fluorescent downlights to canopy over entrance. Tungsten floodlight over rear loading bay door. |
Page 5
|
1 No. | Lighting and power distribution board for offices. | ||
|
1 No. | Distribution board for production area lighting and power. | ||
|
1 No. | External lighting DB stop and control panel. | ||
|
1 No. | Lighting contactors panel. |
Page 6
DATED | 27th September | 2001 |
(1) | AZUR ENVIRONMENTAL LIMITED (Company Registration No 2538199) whose Registered Office is at 540/545 Eskdale Road Winnersh Triangle Wokingham Berkshire RG41 5TU (The Assignor); | |
(2) | MICROSCIENCE LIMITED (Company Registration No 03270465) whose Registered Office is at 545 Eskdale Road Winnersh Triangle Wokingham RG41 5TU (The Assignee) |
(1) | Lease or underlease | |
By a lease particulars of which are set out in the first schedule (the Lease) the property more particularly described in the Lease the postal address of which is set out in the second schedule (the Property) was demised to the Assignor for the term of years and at the yearly rent set out in the first schedule subject to the performance and observance of the covenants on the part of the Assignor and the conditions contained in the Lease and subject to and with the benefit of the document particulars of which are set out in the Third Schedule (the documents). | ||
(2) | Agreement for sale | |
The Assignor has agreed with the Assignee in consideration of the covenant on the part of the Assignee contained below for the assignment to the Assignee of the Property for the residue of the term granted by the Lease subject to and with the benefit of the documents. |
1. | Assignment | |
In pursuance of the above agreement and in consideration of the covenant on the part of the Assignee contained below the Assignor with full title guarantee assigns to the Assignee ALL THAT the Property TO HOLD the Property to the Assignee for the residue now unexpired of the term of years granted by the Lease SUBJECT henceforth to the payment of the rent reserved by and the performance and observance of the covenants and agreements on the part of the lessee and the conditions contained in the Lease and the documents. | ||
2. | Covenant for indemnity | |
The Assignee covenants with the Assignor that it and its successors in title to the Property will during the continuance of the term granted by the Lease |
2
pay the rent reserved by and perform and observe covenants restrictions conditions stipulations and other matters contained or referred to in the Lease and the documents and will keep the Assignor indemnified against all proceedings costs claims and expenses whatsoever on account of any omission to pay the rent reserved by or any breach of any of the covenants agreements and conditions contained in the Lease and in the documents. |
3. | Covenants for title | |
It is hereby agreed and declared between the Assignor and the Assignee that the covenants implied by section 4 of the Law of Property (Miscellaneous Provisions) Act 1994 shall be varied so that the Assignor shall be under no liability for any failure to carry out any works of repair renewal or decoration to the Property or for any other works required under the lease when ever those works are due to be carried out. | ||
4. | Matters of Public Record | |
It is further agreed and declared between the Assignor and the Assignee that for the purposes of section 6(2) Law of Property (Miscellaneous Provisions) Act 1994, all matters now recorded in registers open to public inspection are to be considered with in the actual knowledge of the Assignee. | ||
5. | Contracts (Rights of Third Parties) Act 1999 | |
It is not intended that any term of this deed shall be enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999. | ||
6. | Certificate of value | |
It is hereby certified that the transaction hereby effected does not form part of a larger transaction or of a series of transactions in respect of which the amount or value of the aggregate amount or value of the consideration exceeds the sum of £60,000. |
3
Date | Document | Parties | ||
|
||||
13 December 1996
|
Licence for Alterations | Slough Estates Limited (1) and the Assignor (2) |
4
EXECUTED as a deed by
|
) | |||||
AZUR ENVIRONMENTAL LIMITED
|
) | |||||
Acting by two directors or a director
|
) | |||||
and the company secretary
|
) | |||||
|
) | |||||
|
||||||
|
Director /s/ [Illegible] | |||||
|
||||||
|
Secretary /s/ [Illegible] | |||||
|
||||||
|
For and on behalf of
MAWLAW SECRETARIES LTD |
|||||
|
||||||
EXECUTED as a deed by
|
) | |||||
MICROSCIENCE LIMITED
|
) | |||||
Acting by two directors or a director
|
) | |||||
and the company secretary
|
) | |||||
|
) | |||||
|
||||||
|
Director [Illegible] | |||||
|
||||||
|
Director/Secretary /s/ Jonathan RHH Pockson |
5
- 2 -
- 3 -
- 4 -
- 5 -
- 6 -
- 7 -
- 8 -
- 9 -
- 10 -
- 11 -
- 12 -
- 13 -
- 14 -
- 15 -
- 16 -
- 17 -
ATTEST: | BIOPORT CORPORATION | |||||||||
|
||||||||||
By | /s/ Robert G. Kramer | |||||||||
|
||||||||||
|
Its | President & CEO | ||||||||
|
||||||||||
|
||||||||||
And by | /s/ Ronald S. Huben | |||||||||
|
||||||||||
|
Its | Associate Director of Finance | ||||||||
|
||||||||||
|
||||||||||
FIFTH THIRD BANK | ||||||||||
|
||||||||||
By | /s/ Michael Debri | |||||||||
Michael Debri | ||||||||||
|
Its | Vice President | ||||||||
|
- 18 -
BIOPORT CORPORATION | ||||||||
|
||||||||
By | /s/ Robert G. Kramer | |||||||
|
||||||||
|
Its | President and CEO | ||||||
|
||||||||
|
||||||||
And by Patricia D. Saam | ||||||||
|
||||||||
|
Its | Controller | ||||||
|
||||||||
|
||||||||
FIFTH THIRD BANK | ||||||||
|
||||||||
By | /s/ Mark Conn | |||||||
|
||||||||
|
Its | Vice President | ||||||
|
2
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
|
Bank: | Mercantile Potomac Bank | ||
|
702 Russell Avenue, Suite 200 | |||
|
Gaithersburg, Maryland 20877 | |||
|
Attention: Brett W. Kaplowitz, Senior Vice President | |||
|
Facsimile Number: (301) 963-7683 | |||
|
||||
|
With Copy to: | Lerch, Early & Brewer, Chartered | ||
|
3 Bethesda Metro Center, Suite 460 | |||
|
Bethesda, Maryland 20814 | |||
|
Attn: Lawrence G. Lerman, Esquire | |||
|
Facsimile Number: (301) 347-1776 | |||
|
||||
|
Borrower | |||
|
and Guarantor: | Advanced BioSolutions, Inc. | ||
|
Emergent BioSolutions Inc. | |||
|
Bioport Corporation | |||
|
Antex Biologics Inc. | |||
|
c/o Antex Biologics Inc. | |||
|
300 Professional Drive, Suite 100 | |||
|
Gaithersburg, MD 20879 | |||
|
Attn: President | |||
|
Facsimile Number: (301) 529-1252 | |||
|
||||
|
With Copy to: | Thelen Reid & Priest LLP | ||
|
701 Pennsylvania Avenue, NW, Ste 800 | |||
|
Washington, DC 20004 | |||
|
Attn: Carl A. Valenstein, Esq. | |||
|
Facsimile Number: (202) 654-1836 |
23
24
25
26
ATTEST: | ADVANCED BIOSOLUTIONS, INC. | |||||
|
||||||
/s/ Jose Ochoa
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||
|
||||||
Name: Fuad El-Hibri | ||||||
Title: President | ||||||
|
||||||
ATTEST: | MERCANTILE POTOMAC BANK | |||||
|
||||||
/s/ [Illegible]
|
By: | /s/ Brett W. Kaplowitz | (SEAL) | |||
|
||||||
Name: Brett W. Kaplowitz | ||||||
Title: Senior Vice President |
27
ATTEST: | ANTEX BIOLOGICS INC. | |||||
|
||||||
/s/ [Illegible]
|
By: | /s/ Robert G. Kramer | (SEAL) | |||
|
||||||
Name: Robert G. Kramer | ||||||
Title: President | ||||||
|
||||||
BIOPORT CORPORATION | ||||||
|
||||||
/s/ Jose Ochoa
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||
|
||||||
Name: | ||||||
Title: CEO | ||||||
|
||||||
EMERGENT BIOSOLUTIONS INC. | ||||||
|
||||||
/s/ Jose Ochoa
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||
|
||||||
Name: | ||||||
Title: CEO |
28
$7,000,000.00 | October 14, 2004 |
2
3
|
Bank: | Mercantile Potomac Bank | ||
|
702 Russell Avenue, Suite 200 | |||
|
Gaithersburg, Maryland 20877 | |||
|
Attention: Brett W. Kaplowitz, Senior Vice President | |||
|
Facsimile Number: (301) 963-7683 | |||
|
||||
|
With Copy to: | Lerch, Early & Brewer, Chartered | ||
|
3 Bethesda Metro Center, Suite 460 | |||
|
Bethesda, Maryland 20814 | |||
|
Attn: Lawrence G. Lerman, Esquire | |||
|
Facsimile Number: (301) 347-1776 | |||
|
||||
|
Borrower: | Advanced BioSolutions, Inc. | ||
|
c/o Antex Biologies Inc. | |||
|
300 Professional Drive | |||
|
Gaithersburg, MD 20879 | |||
|
Attn: President | |||
|
Facsimile Number: (301) 590-1252 | |||
|
||||
|
With Copy to: | Thelen Reid & Priest LLP | ||
|
701 Pennsylvania Avenue, NW, Ste 800 | |||
|
Washington, DC 20004 | |||
|
Attn: Carl A. Valenstein, Esq. | |||
|
Facsimile Number: (202) 654-1836 |
4
5
WITNESS/ATTEST: | ADVANCED BIOSOLUTIONS, INC. | |||||||
|
||||||||
/s/ Jose Ochoa
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||||
|
Fuad El-Hibri, President |
6
WITNESS/ATTEST: | BIOPORT CORPORATION | |||||||
|
||||||||
/s/ Jose Ochoa
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||||
|
||||||||
|
Its: | CEO | ||||||
|
||||||||
|
||||||||
/s/ Jose Ochoa | EMERGENT BIOSOLUTIONS INC. | |||||||
|
||||||||
|
By: | /s/ Fuad El-Hibri | (SEAL) | |||||
|
||||||||
|
||||||||
|
Its: | CEO | ||||||
|
||||||||
|
||||||||
ANTEX BIOLOGICS INC. | ||||||||
|
||||||||
|
By: | (SEAL) | ||||||
|
||||||||
|
||||||||
|
Its: | |||||||
|
SUBSCRIBED AND SWORN TO before me this 14 th day of October, 2004. |
|
/s/ Sheila J. Glick | |||
|
|
7
WITNESS/ATTEST: | BIOPORT CORPORATION | |||||||
|
||||||||
|
By: | (SEAL) | ||||||
|
||||||||
|
Its: | |||||||
|
||||||||
|
||||||||
EMERGENT BIOSOLUTIONS INC. | ||||||||
|
||||||||
|
By: | (SEAL) | ||||||
|
||||||||
|
||||||||
|
Its: | |||||||
|
||||||||
|
||||||||
/s/ Michael Zamaria | ANTEX BIOLOGICS INC. | |||||||
|
||||||||
|
By: | /s/ Robert G. Kramer | (SEAL) | |||||
|
||||||||
|
||||||||
|
Its: | President | ||||||
|
|
/s/ Evelyn I. Heald | |||
|
|
8
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Report Date | Effective Date of Information | |
February 15, 2010
|
December 31, 2009 | |
February 15, 2011
|
December 31, 2010 | |
February 15, 2012
|
December 31, 2011 | |
February 15, 2013
|
December 31, 2012 |
WITNESS: |
DEPARTMENT OF BUSINESS AND ECONOMIC
DEVELOPMENT |
|||||||||
|
||||||||||
/s/ Gloria M. Shryock | By: | /s/ Aris Melissaratos | ||||||||
Name:
|
Gloria M. Shryock | Name: | Aris Melissaratos | |||||||
|
||||||||||
|
Title: | Secretary | ||||||||
|
||||||||||
WITNESS: | ADVANCED BIOSOLUTIONS, INC . | |||||||||
|
||||||||||
/s/ José Ochoa | By: | /s/ Y. F. El-Hibri | (SEAL) | |||||||
Name:
|
José Ochoa | Name: | Y. Fuad El-Hibri | |||||||
|
||||||||||
|
Title: | President | ||||||||
|
23
|
/s/ Robin G. Whitfield | |||
|
||||
|
Notary Public |
|
/s/ [Illegible] | |||
|
||||
|
Notary Public |
24
25
Costs Paid by | ||||||||
Costs of Project | MEDAAF | Other Source | Other Source | Other Source | ||||
TOTAL:
|
*(Please specify in parenthesis the entity which paid each particular cost.) |
27
28
Recipient: Advanced BioSolutions, Inc.
|
Recipients Attorney: Richard Newman | |
Finance Specialist: Mary DiFerdinando
|
AAG: David Rawle | |
Title Company: Chicago Title
|
Title Company Attorney: Richard Zeidman/Jon Frank |
October 5, 2004
Item
Received
Reviewed
Accepted
Responsibility
X
BioSolutions
X
BioSolutions
X
BioSolutions
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
BioSolutions
X
Title
X
BioSolutions
BioSolutions
X
BioSolutions
X
BioSolutions
BioSolutions
X
BioSolutions
X
BioSolutions
BioSolutions
X
BioSolutions
BioSolutions
BioSolutions
X
DBED
X
DBED
X
DBED
X
DBED
X
DBED
X
DBED
X
Bank
2
October 5, 2004
3
28
Letter of Credit No.: | ||||||
|
||||||
Name of Project: | ||||||
|
||||||
|
||||||
|
Date: | |||||
|
Maryland Department of Business and Economic Development | |
|
217 East Redwood Street, 22nd Floor | |
|
Baltimore, Maryland 21202 | |
|
Attention: |
2
Very truly yours, | ||||||
|
||||||
[NAME OF BANK ISSUING LETTER
OF CREDIT] |
||||||
|
||||||
|
By: | |||||
|
||||||
|
Title: | |||||
|
3
$2,500,000
|
, 2004 | |
(Financed Amount)
|
, Maryland |
2
3
4
5
ATTEST: | BORROWER: | |||||
|
||||||
ADVANCED BIOSOLUTIONS, INC. | ||||||
|
||||||
/s/ Jose Ochoa
|
By: | /s/ Y. Fuad El-Hibri | (SEAL) | |||
Name: Jose Ochoa
|
Name: | Y. Fuad El-Hibri | ||||
|
Title: | President |
|
/s/ Catherine C. Lynch | |
|
||
|
Notary Public |
6
OFFICER No. 04244 | NOTE No. 0904879830 - | |
$2,400,000.00 | August 10, 2004 | |
(Effective Date) |
|
BORROWER: | |||||
|
||||||
Bioport Corporation, a Michigan corporation | ||||||
|
||||||
|
/s/ Michael A. Zamiara
|
|||||
|
(Authorized Signer) | |||||
|
||||||
Michael A. Zamiara, Chief Financial Officer
|
||||||
|
(Print Name and Title) | |||||
|
||||||
|
By: /s/ Scott Heibeck
|
|||||
|
(Authorized Signer) | |||||
|
||||||
Scott Heibeck, Associate Director of Finance
|
||||||
|
(Print Name and Title) |
22) | Cases filed in Madison County, Illinois: |
a) | Goodman v. Abbott Laboratories, et al ., Case No 02-L-641 (filed May 7, 2002); | ||
b) | Livi v. Abbott Labs, et al. , Case No. 02-L-643 (filed April 30, 2002); | ||
c) | Hornstein v. Abbott Laboratories, et al. , Case No. 02-L-642 (filed May 7, 2002); | ||
d) | Delghingaro v. Abbott Laboratories , Case No. 02-L-1344 (filed September 30, 2002); | ||
e) | Gabor v. Abbott Laboratories , Case No. 02-L-1345 (filed September 30, 2002); | ||
f) | Robinson v. Abbott Laboratories , Case No. 02-L-1346 (filed September 30, 2002); | ||
g) | Howard v. Abbott Laboratories , Case No. 02-L-1487 (filed November 4, 2002); | ||
h) | Trocke v. Abbott Laboratories , Case No. 02-L-1486 (filed November 4, 2002); | ||
i) | Curia (Christopher) v. Abbott Laboratories , Case No. 02-L-1593 (filed December 2, 2002); | ||
j) | Mahnke v. Abbott Laboratories , Case No. 02-L-1594 (filed December 12, 2002); | ||
k) | Barkwell v. Abbott Laboratories , Case No. 02-L-845 (filed June 13, 2002); | ||
l) | Choate v. Abbott Laboratories , Case No. 02-L-844 (filed June 13, 2002); | ||
m) | Conrick v. Abbott Laboratories , Case No. 02-L-843 (filed June 13, 2002); | ||
n) | Curia v. Abbott Laboratories , Case No. 02-L-842 (filed June 13, 2002); | ||
o) | Guinn v. Abbott Labs , Case No. 02-L-841 (filed June 13, 2002); | ||
p) | Owczarzak v. Abbott Laboratories , Case No-L-840 (filed June 13, 2002); | ||
q) | Thomason v. Abbott Labs , Case No. 02-L-896 (filed June 26, 2002); |
r) | Strohbeck v. Abott Laboratories , Case No. 03-L-93 (filed January 27, 2003); | ||||
s) | Kramer v. Abbott Labs , Case No. 03-L-670 (filed May 22, 2002); | ||||
t) | Zezulak v. Abbott Labs , Case No. 03-L-1175 (filed August 25, 2003); | ||||
u) | Spaetzel v. Abbott Labs , Case No. 03-L-1972 (filed December 5, 2003); | ||||
v) | Sexton v. Abbott Labs , Case No. 03-L-1971 (filed December 5, 2003); | ||||
w) | Weider v. Abbott Labs , Case No. 03-L-1559 (filed November 19, 2003); | ||||
x) | Weider (II) v. Abbott Labs, No. 04-L-181 (filed February 23, 2004); | ||||
y) | Fredericks v. Abbott Labs , Case No. 03-L-1037 (filed July 23, 2003); | ||||
z) | Vaselopulos v. Abbott Labs , No. 03-L-1176 (filed August 25, 2003); | ||||
aa) | Villareal v. Abbott Labs, Case No. 04-L-180 (filed February 23, 2004); | ||||
bb) | Peterman v. Abbott Labs, Case No. 04-L-0443 (filed April 1, 2004); | ||||
cc) | Sumner v. Abbott Labs, Case No . 04-L-442 (filed May 25, 2004); | ||||
dd) | Miller (Alan & Kimberly) v. Abbott Labs, et, al., Case No 04-L-443 (filed May 25, 2004); | ||||
ee) | Miller (II) v. Abbott Labs, Case No. 04-L-650 (filed June 18, 2004); and | ||||
Case filed in Cook County, Illinois: | |||||
ff) | Reilly v. Abbott Labs , Case No. 02-L-14697 (filed November 20, 2002). |
Unpaid Principal and Interest | ||||||||||
Creditor | Description | as of June 30, 2004 | Collateral | |||||||
State of Michigan
|
Royalty Obligation | 3,629,599 | none | |||||||
State of Michigan
|
Product Donation Obligation | 2,236,880 | none | |||||||
|
Environmental Remediation | |||||||||
State of Michigan
|
Liability | 317,051 | none | |||||||
US Dept. of Defense
|
FAV026 Obligation | 970,205 | none | |||||||
US Dept. of Defense
|
Spare Parts Obligation | 429,812 | none | |||||||
Pitney Bowes
|
Copiers & Fax Machines | 103,900 | copiers & equipment | |||||||
|
Schedule Numbers: | |||||||||
|
5395546-314 | |||||||||
|
5395546-315 | |||||||||
|
5395546-316 | |||||||||
|
5395546-317 | |||||||||
Ingersol
|
Bobcat Operating Lease | 14,215 | Bobcat | |||||||
GMAC
|
2002 Chevrolet Minivan | 19,708 | 2002 Chevy Minivan | |||||||
GMAC
|
2001 Chevrolet Silverado | 558 |
2001 Chevy
Silverado |
|||||||
Volkswagon USA
|
2001 Volksagon Passat | 13,816 | 2001 Passat | |||||||
GE Capital
|
Copier Operating Leases | 14,210 | 2 Copiers | |||||||
|
ESOP Stock Repurchase | |||||||||
BioPort Employees
|
Obligation | 900,061 | none | |||||||
|
Antex Building Operating | |||||||||
Alexandria Real Estate
|
Lease through 12/1/08 | 4,320,000 | none | |||||||
|
EWR Building Operating | |||||||||
East West Resources
|
Sublease through 7/31/05 | 143,000 | none |
2
3
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5
6
7
8
9
10
11
12
13
14
15
16
17
|
Bank: | HSBC Realty Credit Corporation (USA) | ||
|
1130 Connecticut Avenue, N. W., 12 th Floor | |||
|
Washington, D. C. 20036 | |||
|
Attention: Jeffrey M. Henry, Vice President | |||
|
Facsimile Number: (202) 496-8758 | |||
|
||||
|
With Copy to: | McGuireWoods LLP | ||
|
1750 Tysons Boulevard, Suite 1800 | |||
|
McLean, Virginia 22102-3915 | |||
|
Attn: E. Kristen Moye, Attorney-at-Law | |||
|
Telecopier: 703-712-5238 |
18
|
Borrower and | |||
|
Guarantor: | Emergent Frederick LLC | ||
|
Emergent Biosolutions Inc. | |||
|
300 Professional Drive, Suite 100 | |||
|
Gaithersburg, MD 20879 | |||
|
Attn: Don Elsey, Vice President and | |||
|
Attn: Legal Department | |||
|
Facsimile Number: (301) 590-1252 | |||
|
||||
|
With Copy to: | Linowes and Blocher LLP | ||
|
7200 Wisconsin Avenue, Suite 800 | |||
|
Bethesda, Maryland 20814 | |||
|
Attn: Richard Zeidman, Esquire | |||
|
Facsimile Number: (301) 654-2801 |
19
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21
22
BORROWER: | ||||||
|
||||||
ATTEST: | EMERGENT FREDERICK LLC, | |||||
a Maryland limited liability company | ||||||
|
||||||
/s/ [Illegible]
|
By: | /s/ Edward J. Arcuri | (SEAL) | |||
|
||||||
|
Name: | Edward J. Arcuri | ||||
|
Title: | Executive Manager | ||||
|
||||||
GUARANTOR: | ||||||
|
||||||
ATTEST: | EMERGENT BIOSOLUTIONS INC. | |||||
a Delaware corporation | ||||||
|
||||||
/s/ [Illegible]
|
By: | /s/ Edward J. Arcuri | (SEAL) | |||
|
||||||
|
Name: | Edward J. Arcuri | ||||
|
Title: | EVP & COO | ||||
|
||||||
|
BANK: | |||||
|
||||||
HSBC REALTY CREDIT CORPORATION (USA), | ||||||
a Delaware corporation | ||||||
|
||||||
|
By: | /s/ Jeffrey M. Henry | (SEAL) | |||
|
||||||
|
Name: | Jeffery M. Henry | ||||
|
Title: | Vice President |
23
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3
4
5
6
7
8
9
10
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12
Very truly yours,
MERCANTILE POTOMAC BANK |
||||
By: | /s/ Christopher A. Hesen | |||
Name: | Christopher A. Hesen | |||
Title: | Senior Vice-President | |||
By:
|
/s/ Fuad El-Hibri
|
|||
|
Title: |
By:
|
/s/ John L. Thompson Jr.
|
|||
|
President of the Board of County Commissioners |
Purchaser:
|
Mercantile Potomac Bank (Bank) | |
|
||
Issuer:
|
County Commissioners of Frederick County (County or Issuer). | |
|
||
Amount:
|
Not to exceed $325,000.00 | |
|
||
Purpose:
|
To fund certain allowable expenditures, including the acquisition of land and site work for the Dudrow Industrial Park, Lot Three Development District also known as the Units 1, 2 & 3 Wedgewood IV Land Condo. | |
|
||
Term:
|
Five years. | |
|
||
Repayment:
|
Annual payments of principal and interest beginning on December 1, 2005 and annually thereafter due on December 1 st of each year. | |
|
||
Funding:
|
Funding will occur on or before March 31, 2005. | |
|
||
Interest Rate:
|
Fixed rate for the five year term at 6.625% (taxable) or the 4.08% (tax- exempt). | |
|
||
Facility/
|
||
Collateral:
|
The facility (Bond) will be a limited obligation of the County under which ninety percent (90%) of the incremental increase of real estate taxes (Incremental Taxes) from the TIF district will be deposited in a a special fund and pledged to pay the Bond. Subject to the countys consent, in the event of a default or insufficient debt service coverage, 100% of the Incremental Taxes then remaining in the special fund created to hold the Incremental Taxes will be pledged for debt service requirements and collection expenses of the Bond. |
1. | Ninety percent (90%) of the Incremental Taxes will be pledged to the debt service assigned to the Bond so that a minimum ratio of 1.0:1.0 of taxes pledged (as a result of final tax assessed value on the property) to annual debt service will be maintained. See Schedule A example of calculation. |
2. | The Bond will also be subject to a Bond Purchase Agreement entered into by the Purchaser, the County and Emergent Biologics Inc. (Emergent), which will include the terms and provisions set forth above as well as other terms and conditions reasonably acceptable to the Issuer and Purchaser including the Issuers covenant to treat the Property in a manner consistent with that of other delinquent taxpayers and to offer the Property for sale under its tax lien in the ordinary course of its tax collection activities. |
1. | Any material change in the conditions contained in this letter, as determined by the Purchaser in its sole discretion, will allow the Purchaser to terminate this letter agreement by written notice to the County, and thereupon Purchaser shall have no further obligations to the County to purchase the bond or otherwise perform any obligation set forth herein or in other related document or agreement. | ||
2. | Documentation: All documents evidencing or securing the Bond and any other Liabilities (collectively, the Bond Documents) or relating to any such documents and such other documents, instruments, opinions, assurance, consents, and approvals as the Purchaser may deem necessary shall be subject to the approval of and shall be in form and content satisfactory to the Purchaser and its counsel in their sole but reasonable discretion. In particular, such documents may include, without limitation, but subject to existing and future Deeds of Trust affecting the property, in the sole discretion of the Purchaser and its counsel, provision for application of condemnation proceeds for restoration of the improvements. | ||
3. | Expenses : Emergent shall pay all fees, expenses, costs and charges with respect to the issuance of the Bond, or in any way connected therewith, including, but not limited to attorneys fees and expenses (including Purchasers counsels fees and expenses). The Issuers counsel will prepare the Bond Documents. Such expenses may be funded by the proceeds of the Bond. | ||
4. | Interest Computation : Late Charges: Interest on the Bond shall be computed on the basis of thirty (30) day months and a 360-day year. Upon default under the Bond documents, a late charge equal to the lesser of five percent (5%) per month or the interest rate otherwise chargeable for the delinquent tax payments based upon the incremental tax payment due for that current tax |
year shall be payable from incremental taxes or other funds then available in the special fund, which charge should accrue if any payment of principal or interest pursuant to the bond shall be more than fifteen (15) days delinquent and such interest shall continue to accrue until the default is cured or the Bond is paid in full. | |||
5. | Evidence of Compliance, etc. Evidence satisfactory to the Purchaser that: |
i. | The Bond and actual use of the Property complies in all material respects with all laws, ordinances, rules and regulations of all governmental authorities having jurisdiction over the same. | ||
ii. | All requisite approvals for occupancy of the facility have been validly granted without qualifications; and | ||
iii. | There are no actions or proceedings pending before any court or administrative agency or governmental body at the time which materially and adversely affect the Issuers or Emergent ability to honor its obligations under the Bond |
6. | Hazardous Materials : Emergent shall represent and warrant that it is in compliance with the provision of the Deed of Trust and Loan Agreement dated October 12, 2004 between it and the Bank in respect to Hazardous Materials as therein defined. | ||
7. | Assignment: Except to reimburse Emergent for qualifying expenditures, the proceeds of the Bond shall not be assigned by the Issuer without the prior written consent of the Purchaser, and any such assignment without such consent shall be void and, at the option of the Purchaser, be deemed a default, hereunder. The Bond and any other bond or documentation connected with or contemplated by this transaction may be placed, assigned, serviced, and/or participated out (either in whole or in part) by the Purchaser and/or its successors and assigns. | ||
8. | Termination : The Purchaser may terminate this commitment if, except as may be otherwise provided herein, the Bond or any other feature of the transaction has been or is misrepresented by the Issuer, or any third party in the bond application or otherwise, or if any adverse change, in the sole but reasonable judgment of the Purchaser, shall have occurred with respect to any part of this transaction. | ||
9. | Actions by the Purchaser : No statement, agreements, or representations oral or written, which may have been made to the Issuer or any third party or to any employee or agent of the Issuer, either by the Purchaser or by any employee, agent, or broker acting on the Purchasers behalf, with respect to the Bond, shall be of any force or effect, except to the extend stated in this commitment, and all prior agreements and representations with respect to the Bond are merged herein. This commitment may not be changed except by written agreement signed by the Issuer and the Purchaser. |
Witness: |
Board of County Commissioners Of
Frederick County |
|||
|
||||
|
By: | |||
|
Current Estimate | ||||||||
As of January 1, 2004
|
Land
|
$ | 773,600.00 | |||||
As of July 1, 2005
|
Building
|
$ | 18,716,062.00 | |||||
|
||||||||
Assessment Ratio: | 100 | % | ||||||
Assessable Base: | $ | 18,716,062.00 | ||||||
Less Original Assessable Base: | (773,600.00 | ) | ||||||
|
||||||||
Adjusted Assessable Base: | $ | 17,942,462.00 |
County Tax Rate
|
$ | 1.00 | ||
County Base Tax Revenue
|
$ | 7,736.00 | ||
Tax Increment Revenue
|
$ | 179,424.00 | ||
Pledged Allocation @ 90%
|
$ | 161,481.00 |
Taxable Rate | Tax-Exempt Rate | |||
|
||||
Rate
|
6.625% | 4.08% | ||
Principal
|
$325,000.00 | $325,000.00 | ||
Term
|
60 Months | 60 Months | ||
P&I
|
$78,669.73 | $ 73,287.33 | ||
|
||||
Coverage
|
2.053X | 2.203X |
No. R-1 | $300,000.00 |
Annual Interest Rate | Maturity Date | Bond Date | ||
4.08% | December 1, 2009 | March ___, 2005 |
-2-
-3-
ATTEST: | COUNTY COMMISSIONERS OF FREDERICK COUNTY | |||||
|
||||||
By:
|
By: | |||||
|
||||||
|
Douglas D. Browning | John L. Thompson, Jr. | ||||
|
County Manager | President, Board of County Commissioners of Frederick County |
-4-
Signature Guaranteed:
|
||
|
||
|
||
NOTICE: Signatures must be guaranteed by
a member firm of the New York Stock Exchange
or a commercial bank or trust
company
|
(Signature of Registered Owner)
NOTICE: Signature must correspond with the name of the Registered Owner of the within bond as it appears on the face of the within bond in every particular, without alteration or enlargement or any change whatever |
-5-
(i) | Bond Identifying Number: R-I | |
(ii) | Company Name: EMERGENT BIOLOGICS INC. | |
(iii) | Property Address: 7114, 7116 and 7118 Geoffrey Way, Frederick, Maryland 21701 | |
(iv) | (a) Original Loan Term: 5 years | |
(b) Original Final Maturity: December 1, 2010 | ||
(v) | Bond Interest Rate: 4.08% per annum | |
(vi) | First Monthly Payment Due Date: December 1, 2005 | |
(vii) | Annual Payment Amount: 12/01/05 $64,113.84; each 12/01 thereafter $67,649.84 [+ Annual Servicing Fee $0] | |
(viii) | Original Principal Balance: $300,000.00 |
-6-
210 Allegheny Avenue
Telephone 410-494-6200
www.venable.com
Post Office Box 5517
Facsimile 410-821-0147
Towson, Maryland 21285-5517
Winchester Hall
12 E. Church Street
Frederick, Maryland 21701
702 Russell Avenue Suite 200
Gaithersburg, Maryland 20877
Re:
$300,000 Frederick County, Maryland
Tax Increment Financing Bond
(Dudrow Industrial Park Lot Three Development District) Series 2005
March
, 2005
Page 2
March
, 2005
Page 3
March
, 2005
Page 4
March
, 2005
Page 5
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
|
||||||
1.
|
DEFINITIONS AND INTERPRETATION | 1 | ||||
|
||||||
2.
|
COLLABORATION | 17 | ||||
|
||||||
3.
|
STEERING COMMITTEE | 18 | ||||
|
||||||
4.
|
JOINT PROJECT TEAM | 22 | ||||
|
||||||
5.
|
CONDUCT OF THE DEVELOPMENT PROGRAMME | 25 | ||||
|
||||||
6.
|
COMMERCIALISATION OF PRODUCT | 36 | ||||
|
||||||
7.
|
MILESTONE AND ROYALTY PAYMENTS | 38 | ||||
|
||||||
8.
|
LICENCE GRANTS | 45 | ||||
|
||||||
9.
|
INTELLECTUAL PROPERTY | 47 | ||||
|
||||||
10.
|
CONFIDENTIALITY | 51 | ||||
|
||||||
11.
|
REGULATORY MATTERS | 54 | ||||
|
||||||
12.
|
WARRANTIES | 55 | ||||
|
||||||
13.
|
INDEMNIFICATION | 56 | ||||
|
||||||
14.
|
TERM AND TERMINATION | 58 | ||||
|
||||||
15.
|
FORCE MAJEURE | 67 | ||||
|
||||||
16.
|
PUBLICITY | 68 | ||||
|
||||||
17.
|
NOTICES | 69 | ||||
|
||||||
18.
|
RELATIONSHIP OF PARTIES | 71 | ||||
|
||||||
19.
|
ASSIGNMENT AND DELEGATION | 71 | ||||
|
||||||
20.
|
THIRD PARTY RIGHTS | 72 | ||||
|
||||||
21.
|
WAIVER | 72 | ||||
|
||||||
22.
|
SEVERABILITY | 72 | ||||
|
||||||
23.
|
ENTIRE AGREEMENT | 73 | ||||
|
||||||
24.
|
AMENDMENTS | 73 | ||||
|
||||||
25.
|
GOVERNING LAW AND JURISDICTION | 73 |
SCHEDULE 1 | DEVELOPMENT PLAN | |||
|
||||
Appendix 1 | Outline Candidate Evaluation and Selection Plan | |||
|
||||
Appendix 2 | Phase I Product and Clinical Development Plan | |||
|
||||
Appendix 3 | Later Stage Clinical Development Plan | |||
|
||||
SCHEDULE 2 | INDICATIVE COST SCHEDULE | |||
|
||||
SCHEDULE 3 | CANDIDATE ANTIGENS | |||
|
||||
SCHEDULE 4 | OUTLINE COMMERCIALISATION PLAN | |||
|
||||
SCHEDULE 5 | EMERGENT INDEPENDENT PATENT RIGHTS | |||
|
||||
SCHEDULE 6 | PRESS ANNOUNCEMENT | |||
SCHEDULE 7 | ACTIVITY FORM | |||
SCHEDULE 8 | THE INCLUSION CRITERIA | |||
SCHEDULE 9 | PATENT FILING COUNTRIES | |||
SCHEDULE 10 | WORKED EXAMPLES | |||
SCHEDULE 11 | TERMINATED ANTIGENS |
THIS AGREEMENT is dated | 2006 |
(A) | Emergent has intellectual property and related ongoing research activity directed towards the development of a vaccine to prevent Neisseria meningitidis serogroup B infections. | |
(B) | sanofi pasteur has expertise in clinical development and registration of meningitis and paediatric vaccines. | |
(C) | Emergent and sanofi pasteur agree that a collaboration between them will accelerate the pre-clinical, and early clinical development of a prophylactic vaccine against Neisseria meningitidis infections and wish to enter into such collaboration on the terms and conditions of this Agreement. |
1. | DEFINITIONS AND INTERPRETATION | |
1.1 | In this Agreement the following definitions shall have the following meanings unless otherwise expressly provided or unless the context otherwise requires: | |
Activity Forms means the activity forms to be completed by Emergent employees and consultants engaged in Emergent Activities in the form set out in Schedule 7. | ||
Additional Antigen means a sanofi pasteur Antigen or a Third Party Antigen that satisfies the Inclusion Criteria. | ||
Adjusted Combination Net Sales has the meaning set out in the definition of Net Sales. | ||
Adolescent means a young adult between 11 and 18 (inclusive) years of age. | ||
Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a Clinical Candidate or Product, whether or not caused by the treatment, including any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (including clinically significant worsening of a disease or pre-existing condition) temporally related to a Clinical Candidate or Product. Adverse Event also means any report of lack of efficacy of a |
1
Clinical Candidate or Product and any treatment of a pregnant woman, any abuse or overdose (accidental or intentional), any other accidental exposure and lack of expected pharmacological action temporally related to a Clinical Candidate or Product. |
2
3
4
5
6
7
8
(a) | normal and customary trade or quantity discounts to the extent included on the invoice as a separate item, credits, allowances, rebates, returns (including wholesaler and retailer returns); | ||
(b) | retroactive price reductions; | ||
(c) | excise taxes, other consumption taxes, customs duties and compulsory payments made to governmental authorities to the extent included on the invoice as a separate item; | ||
(d) | normal and customary sales commissions that are actually paid to Third Party distributors and Third Party selling agents to the extent included on the invoice as a separate item; and | ||
(e) | transportation, transit and insurance for transportation each to the extent separately invoiced and paid by sanofi pasteur. |
(i) | if sanofi pasteur has already launched a Unitary Product in such country, A shall be the highest official list price of the Unitary Product in that country in the relevant Quarter; | ||
(ii) | if sanofi pasteur has not already launched a Unitary Product in such country, but a unitary product for exactly the same indications as the Unitary Product is already on the market in such country, A shall be the highest official list price of such competitive unitary product in such country in such Quarter. For the avoidance of doubt, if there is more than one competitive unitary product on the relevant market, then |
9
A shall be referenced to the competitive unitary product with the highest official list price in such country in such Quarter; | |||
(iii) | B shall be the highest official list price in such country in such Quarter of the other product included in the Combination Product; | ||
(iv) | if when sanofi pasteur first submits an application for Marketing Authorisation for a Combination Product in a country or at any time subsequently it is not possible to determine A or B in accordance with paragraphs (i) to (iii) above, the Parties shall seek to agree A or B (as required) but failing such agreement within thirty (30) days (or such longer period as the parties may agree) of either Party notifying the other that such values are to be determined in accordance with this paragraph (iv) either Party can require an independent third party expert to determine such values so that application of the formula A/(A+B) fairly reflects the contribution of the Unitary Product to the value of the Combination Product in that country. Within fifteen (15) days of either Party notifying the other that an expert determination is required, the Parties shall appoint an independent expert with expertise in the field of vaccine development and commercialisation reasonably acceptable to both Parties. If the Parties are unable to agree on the identity of the independent expert within such period, the independent expert shall be appointed by Emergent, and approved by sanofi pasteur, which approval shall not be unreasonably withheld, conditioned or delayed. Within thirty (30) days of such appointment, each of the Parties shall furnish to the expert (subject to such obligations of confidentiality and non-use as may be reasonably required by them), with a copy to the other Party, a written summary of such Partys position as to the values of A and B in such country and any relevant evidence supporting such position. Any such written summary and evidence shall not, unless the Parties otherwise agree, exceed 15,000 words. Within fifteen (15) days of receipt of the other Partys summary (or such longer period as may be required to ensure the presence of the expert) there shall be a one-day oral hearing before the expert at which each Party shall be given an equal opportunity to present its own position and hear and respond to the oral presentation given by the other Party. Within fifteen (15) days of such oral hearing each Party may submit a written rebuttal of the other Partys summary, providing that any rebuttal shall not exceed 5,000 words, and amend its final position with regard to the values of A and B. The expert shall be required by the Parties to select the resolution proposed by one of the Parties that as a whole most fairly and reasonably reflects the relative contributions of the Unitary Product and the other product to the Combination Product and shall provide the Parties with a written statement setting forth the basis of such determination. For the avoidance of doubt, the expert shall only have the right to select a resolution proposed by one of the Parties in its entirety and without modification. The expert shall be required by the Parties to use all reasonable efforts to render his decision within sixty (60) days of his appointment or, if earlier, within thirty days following his receipt of all |
10
such information and such decision shall be final and binding upon each of the Parties unless and until it becomes possible to determine A and B in accordance with paragraphs (i) to (iii) above. If the expert adopts the resolution proposed by Emergent, then sanofi pasteur shall pay the fees and expenses of the expert. If the expert adopts the resolution proposed by sanofi pasteur, then Emergent shall pay the fees and expenses of the expert. If due to any act or omission by one of the Parties, the Parties have not agreed, or the expert has not determined, the values of A and/or B (as required) in any country before launch of the Combination Product in that country, A and/or B (as required) shall be as determined by the other Party. |
(1) | the royalty payable to Emergent pursuant to Clause 7.3 (as adjusted pursuant to Clause 7.4.1 or Clause 7.4.2 if applicable) for such country and Quarter; | ||
(2) | [**] per cent ([**]%) X the royalty rate applicable to the Unitary Product X A/C X Net Sales of the Combination Product (before application of the formula A/(A+B)) where C is the highest official list price of the Combination Product in that country and Quarter and A for that country and Quarter is determined in accordance with paragraphs (i) to (iv) above (as applicable); and | ||
(3) | if the royalty would otherwise be payable pursuant to Clause 7.3(a), [**] per cent ([**]%) X actual Net Sales of the Combination Product in that country and Quarter (before application of the formula A/(A+B)); or if the royalty would otherwise be payable pursuant to Clause 7.3(b), [**] per cent ([**]%) X actual Net Sales of the Combination Product in that country and Quarter (before application of the formula A/(A+B)). |
11
12
13
14
15
1.2 | In this Agreement, unless the context otherwise requires: |
(a) | references to this Agreement shall mean this Agreement and any and all Schedules to it, each as amended from time to time in accordance with the provisions of this Agreement; | ||
(b) | references to a particular Clause, Schedule or paragraph shall be a reference to that clause, schedule or paragraph in this Agreement; | ||
(c) | words in the singular shall include the plural and vice versa and references to the masculine gender shall include the feminine gender and vice versa; | ||
(d) | headings are for convenience only and shall be ignored in interpreting this Agreement; | ||
(e) | reference to a person shall mean any individual, partnership, company, corporation, joint venture, trust, association, organisation or other entity, in each case whether or not having separate legal personality; | ||
(f) | the words include, including or in particular are to be construed without limitation to the generality of the preceding words; | ||
(g) | references to a statute include any statutory modification, extension or re-enactment of that statute; | ||
(h) | any reference to writing includes a reference to any communication effected by facsimile transmission or similar means; | ||
(i) | the word or has the inclusive meaning represented by the phrase and/or; and |
16
(j) | any covenant by a Party not to do an act or thing shall be deemed to include an obligation not to permit or suffer such act or thing to be done by another person. |
1.3 | If there is any inconsistency between Clauses 1 to 28 (inclusive) of this Agreement and any Schedule, such Clauses shall prevail. | |
2. | COLLABORATION | |
2.1 | Objectives and Overview | |
The Parties wish to evaluate and screen the Candidate Antigens, select Clinical Candidates and Develop a Product for use in the Field (the Development Programme ). The Development Programme shall comprise all activities relating to Development. It is anticipated that the majority of Pre-Clinical Studies and Phase I Studies relating to Programme Antigens will be undertaken by Emergent during the Early Development Phase, at sanofi pasteurs cost, and that the majority of Phase II Studies relating to Programme Antigens and the subsequent Development of Programme Antigens (whether during the Early Development Phase or the Late Development Phase) will be undertaken by sanofi pasteur, at its own cost. The SC shall oversee the overall execution of the objectives of the Development Programme and the JPT shall manage the day-to-day running of the collaboration in the Early Development Phase. The Project Leaders shall facilitate the flow of information and otherwise promote communications and collaboration within and among the Parties, the SC, JPT and any other sub-committees or teams that the SC may appoint or constitute. | ||
2.2 | Project Leaders | |
Within sixty (60) days of the Effective Date, each Party shall appoint a senior representative with a good general understanding of the vaccine development process to act as a co-ordinator and project leader ( Project Leader ). Each Party may replace its Project Leader with another suitably qualified individual, on written notice to the other Party. Each Project Leader shall be primarily responsible for the day-to-day management of each Partys activities within the collaboration. | ||
2.3 | Intellectual Property Strategy | |
The Parties acknowledge the importance of effectively securing and managing the intellectual property relating to Programme Antigens and any Product. The Parties shall, consistent with Clause 9 and Schedule 9, seek to obtain and maintain the broadest patent protection that is commercially reasonable across the Territory, extending this protection through additional filings and the use of supplementary protection certificates where appropriate, and to protect the confidentiality of all Know How relating to the Programme Antigens and any Product. | ||
2.4 | Exclusivity | |
Emergent shall not and shall procure that none of its Affiliates shall, other than pursuant to this Agreement, conduct any activity, either on its own, or with, for the benefit of, or sponsored by, any Third Party, that is designed to research, develop or |
17
commercialise, or grant any licence or other rights to any Third Party to utilise, the Programme Antigens for the purpose of researching, developing, commercialising or otherwise Exploiting any product in the Territory provided that this shall not prevent Emergent from Exploiting, or granting a Third Party the right to Exploit, any Co-Exclusive Antigen. | ||
2.5 | Co-operation | |
Emergent and sanofi pasteur shall co-operate in the performance of the Development Plan and each Annual Development Plan and, subject to the terms of this Agreement and any confidentiality obligations to Third Parties, each shall at its own cost (providing that such costs are not substantial), if requested by the other Party, exchange such Materials, data and information in its Control as are reasonably necessary for the other Party to perform its obligations under any Annual Development Plan. | ||
3. | STEERING COMMITTEE | |
3.1 | Establishment and Membership of SC | |
Within sixty (60) days of the Effective Date, Emergent and sanofi pasteur shall establish a Steering Committee ( SC ) comprising not less than six (6) members, with at least three (3) being appointed and replaced by Emergent, of which one shall be the Emergent Project Leader, and at least three (3) being appointed and replaced by sanofi pasteur, of which one shall be the sanofi pasteur Project Leader. All such representatives shall be individuals of suitable authority and seniority with significant experience and expertise in vaccine development, commercialisation or marketing commensurate with the responsibilities and activities of the SC from time to time. Any appointment or replacement shall be notified to the other Party in writing. Any member of the SC may designate a substitute of equal experience and seniority to attend and perform the functions of such member at any meeting of the SC. | ||
3.2 | Meetings | |
The first meeting of the SC shall take place within seventy-five (75) days of the Effective Date. The SC shall meet Quarterly during the Development Programme and thereafter bi-annually and in addition within fifteen (15) days of a request by any SC member to have such a meeting. Meetings may take place by video conference or telephone conference or such other means as the SC shall decide and all members participating in the meeting by video link, telephone or such other means shall be deemed to be present at the meeting, provided however, that the SC shall meet in person at least twice per Year, unless otherwise agreed by the SC. Meetings held in person shall alternate between Emergent and sanofi pasteur designated locations. The first meeting shall be held at sanofi pasteurs facilities. The chair of the SC shall rotate between Emergent and sanofi pasteur from meeting to meeting. The first meeting shall be chaired by a sanofi pasteur representative. The quorum for meetings shall be one sanofi pasteur representative and one Emergent representative. Decisions and determinations of the SC shall be made by unanimous agreement of the members present. Each Party may invite additional employees, or consultants to attend SC meetings but any such additional attendees shall not have any right to vote. The principal business and any decisions of any meeting shall be recorded in minutes |
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which shall be circulated by the chair to the members of the SC promptly following the meeting for review, comment and adoption. | ||
3.3 | Responsibilities of the SC | |
Except as otherwise provided in this Agreement, the SC shall have authority to make all necessary strategic decisions relating to the Development of a Product and the implementation of the Development Plan. Specifically, and in addition to any other responsibilities assigned to the SC elsewhere in this Agreement, the SC shall be responsible for: |
(a) | reviewing and approving any major amendments to the Development Plan (including the Outline Candidate Evaluation and Selection Plan, the Phase I Product and Clinical Development Plan and the Later Stage Clinical Development Plan); | ||
(b) | reviewing and approving each Annual Development Plan and any major amendments thereto; | ||
(c) | reviewing and resolving all significant strategic issues relating to the Development of Unitary Products including the review and approval of: |
(i) | the target product profile of a Product; | ||
(ii) | any go/no go decision points relating to Development; | ||
(iii) | prioritising Candidate Antigens, selecting Clinical Candidates and designating Terminated Antigens; | ||
(iv) | Clinical Study endpoints and success criteria; | ||
(v) | insurance coverage for Clinical Studies; | ||
(vi) | the regulatory strategy for a Product; | ||
(vii) | patent, trademark and other intellectual property strategy and, to the extent applicable, patent, trademark and other intellectual property litigation strategy; |
(d) | reviewing all significant strategic issues (including, as applicable, those matters listed in paragraph c above) relating to the Development of any Combination Product; | ||
(e) | reviewing and approving each Transition Plan; | ||
(f) | reviewing and commenting on the Commercialisation Plan; | ||
(g) | reviewing the efforts of the Parties in performing their respective responsibilities under the Development Plan, any Annual Development Plan, each Transition Plan and the Commercialisation Plan; | ||
(h) | reviewing the implementation of each Transition Plan; and |
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(i) | reviewing and approving any external corporate communication regarding the Development Programme. |
For the avoidance of doubt, if this Agreement provides that any matter is to be determined by the Parties or either of them , such matter shall not be considered to be the responsibility, or within the authority, of the SC. | ||
3.4 | Role of the Project Leader within the SC | |
Within the framework of the SC, each Project Leader shall facilitate the execution of the SCs responsibilities and in particular shall be responsible for: |
(a) | facilitating coordination among the various functional representatives of either Emergent or sanofi pasteur, as appropriate; | ||
(b) | seeking consensus both internally within the respective Partys organisation and together regarding key global Development and Commercialisation strategy and issues concerning the Development Plan, each Annual Development Plan, each Transition Plan and each Commercialisation Plan, as appropriate, including facilitating review of external corporate communications; | ||
(c) | raising to the SC in a timely manner cross-Party or cross-functional disputes, or proposed modifications to any Development Plan, Annual Development Plan, Transition Plan or Commercialisation Plan; | ||
(d) | providing a single point of communication between the SC, the JPT and any subcommittee created pursuant to Clause 3.6; | ||
(e) | submitting to the SC the reports referred to in Clause 5.10; and | ||
(f) | such other matters as the SC may consider appropriate. |
3.5 | SC Dispute Resolution | |
3.5.1 | Escalation of Disputes within the SC . If the SC is unable to resolve any dispute with respect to a matter within the scope of Clause 3.3 within thirty (30) days (or fourteen days (14) days if the matter is expedited in accordance with Clause 3.5.3) after such matter was first referred to or considered by the SC, whichever is earlier, or in such longer period of time as the Parties may agree such matter shall, at the written request of either Party, be referred to the Chief Executive Officer of Emergent and the sanofi pasteur Head of Research and Development (the Senior Officers ) as soon as practicable but in any event no later than fifteen (15) days after such request. Each Senior Officer shall have the right to engage the services of any number of independent experts in the field in question (such independent expert(s) to be engaged under obligations of confidentiality and non-use equivalent to those set out in Clause 10 and at the expense of the Party so engaging such expert(s)) to assist the Senior Officers in making a determination on the unresolved dispute, and each Senior Officer shall consider in good faith the analyses and opinions of any such experts engaged by either of them in making a determination. Subject to Clause 3.5.2, if the Senior Officers are unable to resolve the dispute within thirty (30) days after such referral, or |
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such longer period as the Senior Officers may agree, the sanofi pasteur Head of Research and Development shall be entitled to determine the matter. Any such determination shall be commercially reasonable and consistent with Applicable Law. Prior to resolving any such dispute unilaterally, sanofi pasteur shall consider in good faith Emergents position and the analyses and opinions of any independent expert engaged by Emergent. For the avoidance of doubt, in reaching any such decision sanofi pasteur shall act in good faith and in the best interests of the Development and Commercialisation of a Product but shall not be bound to follow the recommendations of any such expert. For the avoidance of doubt, all other disputes arising under or in connection with this Agreement shall, unless subject to final and binding expert determination in accordance with this Agreement, be resolved in accordance with Clause 25.2 and, if necessary, Clause 25.3. | ||
3.5.2 | Notwithstanding Clause 3.5.1, the sanofi pasteur Head of Research and Development shall not be entitled to determine a dispute with respect to a matter within the scope of Clause 3.3, if such decision relates to any of the following matters and no such proposal or decision with respect to any such matter shall be effective unless and until agreed by Emergent: |
(a) | any proposal to amend the Development Plan, adopt or amend any Annual Development Plan (including any Annual Budget), or adopt or amend any Transition Plan in a manner that alters an existing obligation of Emergent or imposes a new obligation on Emergent; | ||
(b) | any proposal to amend the Outline Candidate Evaluation and Selection Plan (including the Selection Criteria); | ||
(c) | any proposal to amend the standard assay system for measurement of SBA Activity set out in the Development Plan; | ||
(d) | any proposal to use an Alternative Assay to demonstrate the presence of SBAs with a Clinical Candidate or Product unless such proposal is consistent with Clause 5.6.3. | ||
(e) | any proposal to incorporate an Additional Antigen in a Product or include an Additional Antigen in the Development Programme unless such proposal is consistent with the decision of the expert appointed pursuant to Clause 5.7.2; | ||
(f) | any proposal relating to the patent strategy for Emergent Patent Rights or Joint Patent Rights or any proposal to seek patent term extensions regarding the Emergent Patent Rights, the sanofi pasteur Patent Rights or the Joint Patent Rights with respect to any Product in each country in the Territory; | ||
(g) | any decision that would constitute a deviation from any of the terms of, or would require an amendment to, this Agreement (other than an amendment to the Development Plan as expressly permitted in accordance with this Agreement); and | ||
(h) | any proposal that would affect when a milestone payment under Clause 7.2 would be payable. |
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3.5.3 | Expedited Escalation . If either the SC or JPT is unable to resolve a dispute relating to a matter for which it is responsible, either Party may designate such dispute an urgent matter. The SC shall resolve such issue within fourteen (14) days after such matter was first designated an urgent matter. The Parties shall ensure that the SC meets (by teleconference/videoconference as necessary) to discuss and resolve such urgent matter within such period. If the SC does not resolve such matter within such fourteen (14) day period, the matter will be referred to the Senior Officers in accordance with Clause 3.5.1. | |
3.6 | Subcommittees | |
The SC is empowered to create such sub-teams or subcommittees of itself as it may deem appropriate or necessary. Each such sub-team or subcommittee shall report to the SC, which shall have authority to approve or reject recommendations or actions proposed subject to the terms of this Agreement. No sub-team or subcommittee shall have authority to make any decision binding upon the SC or the Parties. For the avoidance of doubt, a Party may appoint the same individual as its representative on more than one committee. | ||
4. | JOINT PROJECT TEAM | |
4.1 | Establishment and Membership of JPT | |
Within sixty (60) days of the Effective Date Emergent and sanofi pasteur shall establish a Joint Project Team ( JPT ) comprising up to six (6) members, with up to three (3) being appointed and replaced by Emergent, of which one shall be the Emergent Project Leader, and up to three (3) being appointed and replaced by sanofi pasteur, of which one shall be the sanofi pasteur Project Leader. All such representatives shall be individuals of suitable authority and seniority with significant experience and expertise in vaccine research and development to commensurate with the responsibilities of the JPT. Any appointment or replacement shall be notified to the other Party in writing. Any member of the SC may designate a substitute of equal experience and seniority to attend and perform the functions of such member at any meeting of the JPT. Any changes to the size of the JPT shall be decided by the SC. Unless otherwise decided by the Parties, the JPT shall be disbanded on the Transition Date and have no further responsibilities thereafter; provided that if the SC determines that pre-clinical Development activities, or a Phase I Study, are to be undertaken with or in connection with a Programme Antigen and it is proposed that all or any of such activities are commenced or continued after the Transition Date or the anticipated Transition Date the JPT shall not be disbanded, or if it has been disbanded it shall be reconstituted before commencement of any such activities. The JPT shall prepare the amendments to the Development Plan and any Annual Development Plan required in connection with such proposed activities and shall not be disbanded until all pre-clinical Development activities and any Phase I Studies for such Programme Antigen are complete or discontinued. | ||
4.2 | Meetings | |
The first meeting of the JPT shall take place within seventy-five (75) days of the Effective Date and thereafter the JPT shall meet monthly or as otherwise determined by the Parties. Meetings may take place by video conference or telephone conference |
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or such other means as the SC shall decide and all members participating in the meeting by video link, telephone or such other means shall be deemed to be present at the meeting, provided however, that the JPT shall meet in person at least once per Quarter, unless otherwise agreed by the SC. Meetings held in person shall alternate between Emergent and sanofi pasteur designated locations. The first meeting shall be held at Emergents facilities. The chair of the JPT shall rotate between Emergent and sanofi pasteur from meeting to meeting, the first meeting shall be chaired by a sanofi pasteur representative. The quorum for meetings shall be one sanofi pasteur representative and one Emergent representative. Decisions and determinations of the JPT shall be made by unanimous agreement of the members present. Each Party may invite additional employees, or consultants to attend JPT meetings but any such additional attendees shall not have any right to vote. The principal business of any meeting shall be recorded in minutes, which minutes shall be circulated by the chairperson to the members of the JPT promptly following the meeting for review, comment and adoption. | ||
4.3 | Responsibilities of the JPT | |
Until the Transition Date (or such later date as the Parties may agree) and during any subsequent period during which the JPT is reconstituted pursuant to Clause 4.1, the JPT shall have the general responsibility for the day-to-day management of the collaboration, including co-ordinating the Development Activities of each of the Parties and making recommendations and referring strategic issues to the SC. Specifically, the JPT shall be responsible for: |
(a) | preparing Annual Development Plans in accordance with Clause 5.3, and submitting such Annual Development Plan to the SC for approval; | ||
(b) | preparing each Transition Plan and submitting such plan to the SC for approval; | ||
(c) | proposing to the SC any amendments to the Development Plan or any Annual Development Plan, including proposals relating to Product Development, the Outline Candidate Evaluation and Selection Plan, and clinical, regulatory and intellectual property strategy, in each case as appropriate to the stage of the Development Programme; | ||
(d) | overseeing and managing the implementation of the Development Plan, and each Annual Development Plan and Transition Plan; | ||
(e) | facilitating the exchange of information and data between the Parties and the Parties representatives engaged in the day-to-day conduct of the Development Activities; | ||
(f) | referring any significant strategic issues relating to the Development Programme, including any issues that have a material effect on quality, cost and time needed to undertake any Development Activities, to the SC; | ||
(g) | making recommendations to the SC with respect to: |
(i) | Development go/no go decision points; |
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(ii) | amendments to the Outline Candidate Evaluation and Selection Plan; | ||
(iii) | the prioritisation of Candidate Antigens, the selection of Clinical Candidates and the designation of Terminated Antigens; | ||
(iv) | Clinical Study endpoints, success criteria and protocols for Clinical Studies; | ||
(v) | insurance requirements for Clinical Studies; |
(h) | co-ordinating and monitoring the regulatory strategy and intellectual property strategy with respect to any Programme Antigen or Product; | ||
(i) | recommending the appointment of any necessary additional subcommittees; | ||
(j) | preparing and submitting to the SC the Transition Plans in accordance with Clause 5.5.1; | ||
(k) | reviewing and then reporting on the efforts of the Parties in performing their respective Development Activities to the SC; and | ||
(l) | such other activities consistent with this Agreement as determined by the SC. |
4.4 | Role of the Project Leader within the JPT | |
Within the framework of the JPT, each Project Leader shall facilitate the execution of the JPTs responsibilities and in particular shall be responsible for: |
(a) | providing a single point of communication between the Parties concerning the day-to-day operation of the collaboration; | ||
(b) | seeking consensus both internally within the respective Partys organisation and together regarding the preparation or implementation of the Development Plan, each Annual Development Plan and Transition Plan and any recommendations to be made by the JPT to the SC; and | ||
(c) | raising to the JPT in a timely manner cross-Party or cross-functional disputes. |
4.5 | Dispute Resolution | |
4.5.1 | Referral to the SC . If the JPT is unable to resolve any dispute with respect to a matter within the scope of Clause 4.3, within thirty (30) days after such matter was first referred to or considered by the JPT, whichever is earlier, then such matter shall, at the written request of either Party, be referred to the SC for resolution. The referral shall be made in writing and if the form of such referral is not agreed each Party may make written submissions to the SC. | |
4.5.2 | Expedited Referral . Either Party may designate a dispute within the JPT an urgent matter and, if the JPT is unable to resolve such dispute within fourteen (14) days of such matter first being designated an urgent matter, either Party may immediately refer such matter to the SC for resolution. |
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5. | CONDUCT OF THE DEVELOPMENT PROGRAMME | |
5.1 | The Development Programme | |
The Development Programme shall be conducted in accordance with this Agreement, the Development Plan and any Annual Development Plan. Each Party shall conduct the Development Activities allocated to it in the Development Plan diligently, in good scientific manner and in compliance with this Agreement, the Development Plan, the relevant Annual Development Plan and Applicable Law. As part of the Development Programme, the Parties will seek to evaluate and screen the Programme Antigens, select Clinical Candidates and Develop a Product. | ||
5.2 | The Development Plan | |
The overall strategy and anticipated budget for the Development of any Product are set out in the first Development Plan attached as Schedule 1. The Development Plan, including the Outline Candidate Evaluation and Selection Plan, Phase I Product and Clinical Development Plan and Later Stage Clinical Development Plan, shall be revised and updated by the SC as and when necessary during the course of the Development Programme with the intent that the Development Plan shall: |
(a) | identify Development Activities to be conducted by each of the Parties and the anticipated timelines for such activities; | ||
(b) | specify the standards applicable to any Development Activities including whether particular Development Activities are to be conducted in accordance with GLP, GMP or GCP; | ||
(c) | include and, if necessary, update the criteria for the selection of Clinical Candidates; | ||
(d) | describe the clinical and regulatory strategy for any Clinical Candidate or Product; | ||
(e) | describe the intellectual property strategy for Emergent Patent Rights and Joint Patent Rights; | ||
(f) | incorporate a manufacturing plan for clinical supplies of Clinical Candidates and any Product; and | ||
(g) | include such other matters as the SC consider appropriate in relation to the Development Programme. |
During the Early Development Phase and during any other period during which the JPT has responsibilities pursuant to Clause 4.3, the JPT, and at any other time, sanofi pasteur, shall be responsible for proposing amendments to the Development Plan. No major amendment to the Development Plan shall be effective until approved by the SC. For the purpose of this Agreement any change to the Development Plan or an Annual Development shall be considered major if the change affects Emergents obligations under the Development Plan or any Annual Development Plan, or, in isolation or in aggregate with any other changes not previously approved by the SC, represents a material change to the resources engaged or to be engaged by sanofi |
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pasteur in the Development of a Product, or affect or might be reasonably expected to affect the anticipated timetable for Development of a Product. sanofi pasteur shall provide Emergent with an up to date summary of the Development Plan and any Annual Development Plan within thirty (30) days of the commencement of each Quarter which summaries shall highlight any amendments (whether or not major amendments) made to such plan in the previous Quarter. sanofi pasteur shall promptly answer any queries raised by Emergent in connection with any such summary. | ||
5.3 | Annual Development Plan and Budget | |
As soon as practicable following the Effective Date, and in any event within sixty (60) days following the Effective Date, the JPT shall submit to the SC, and the SC shall review and agree to, the Annual Development Plan for the First Year (or such other period as the SC may decide). For each subsequent Year (or such other period as the SC may decide) prior to or including the anticipated Transition Date and during any other period during which the JPT has responsibilities pursuant to Clause 4.3, the JPT shall prepare a draft Annual Development Plan. For each Year during the Late Development Phase, sanofi pasteur shall prepare a draft Annual Development Plan (unless the JPT has been reconstituted pursuant to Clause 4.1, in which case the JPT shall prepare the draft Annual Development Plan). Each draft Annual Development Plan shall be submitted to the SC for review, modification and if appropriate, as determined by the SC, approval. The JPT or sanofi pasteur, as the case may be, shall manage the preparation and submission of each draft Annual Development Plan (other than the Annual Development Plan for the First Year) in a manner designed to result in approval of such plan, if there is no dispute within the SC, by no later than thirty (30) days prior to the end of the then-current Year or such other date (taking into account the budget cycle of sanofi pasteur) as the SC may decide. Each Annual Development Plan shall describe with reasonable specificity the Development objectives for, and activities to be performed in, the applicable Year (or other period covered by the Annual Development Plan) and an estimated timeline for such activities. During the Early Development Phase and thereafter if and for so long as the Parties agree that any Development Activities shall be conducted by Emergent, each Annual Development Plan shall identify which Development Activities are Emergent Activities and with respect to such Emergent Activities the number of FTEs estimated to be required to perform such activities, the corresponding estimated FTE Cost, and the estimated Emergent Expenses (such estimates for each Year, once approved by the SC, an Annual Budget ). The Annual Budget for the First Year shall be based on the Indicative Cost Schedule. Each Annual Budget shall be reviewed and if appropriate updated in June of each year or at such other time or times as the SC may agree. No major amendment to an Annual Development Plan shall be effective until approved by the SC. All FTE Costs and Emergent Expenses incurred by Emergent in connection with the Emergent Activities shall be paid by sanofi pasteur in accordance with Clause 5.13. | ||
5.4 | The Early Development Phase | |
5.4.1 | Conduct . During the Early Development Phase each Party shall undertake the Development Activities allocated to it in the relevant Annual Development Plan. It is anticipated that the majority of Pre-Clinical Studies and Phase I Studies will be |
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undertaken by Emergent. In particular, Emergent shall, with assistance from sanofi pasteur and at sanofi pasteurs cost, (i) evaluate and screen the Candidate Antigens and the SC shall select Clinical Candidates as more particularly described in the Outline Candidate Evaluation and Selection Plan; and (ii) Develop Clinical Candidates and undertake Phase I Studies as more particularly described in the Phase I Product and Clinical Development Plan. | ||
5.4.2 | Role of the JPT . The JPT shall be responsible for day-to-day management of the Development Programme during the Early Development Phase and any subsequent period during which pre-clinical Development Activities or a Phase I Study are to be undertaken with or in connection with a Programme Antigen, and in particular shall have the responsibilities set out in Clause 4.3. Each of sanofi pasteur and Emergent shall cause its representatives on the JPT to collaborate with the other Partys representatives in the discharge of those responsibilities. In addition to the reports prepared pursuant to Clause 5.10, each of Emergent and sanofi pasteur shall keep the other informed of the conduct of their respective Development Activities through the JPT and their respective Project Leaders. | |
5.5 | Transition from Early Development to Late Development | |
5.5.1 | Transition Plans . If sanofi pasteur notifies Emergent that it intends to progress a Clinical Candidate into a Phase II Study, the JPT shall prepare and submit to the SC a transition plan for such Clinical Candidate (each a Transition Plan ), which plan shall provide for the smooth, orderly and cost-effective transfer of principal responsibility for the conduct of Development Activities relating to that Clinical Candidate from Emergent to sanofi pasteur and shall include each Partys responsibilities (and, with respect to any responsibilities allocated to Emergent, the estimated FTE Costs and Emergent Expenses) and a timetable for such transfer. The Transition Plan shall provide for: |
(a) | securing supplies of any Clinical Candidate as required for planned Clinical Studies involving that Clinical Candidate; | ||
(b) | the transfer of copies of all relevant information, files or data relating to the Clinical Candidate; | ||
(c) | the assignment and transfer from Emergent to sanofi pasteur of all of Emergents rights, title or interest in or to any Regulatory Documentation and Regulatory Approvals relating to that Clinical Candidate then in Emergents name; provided that if the Clinical Candidate is a Co-Exclusive Antigen Emergent shall only be required to grant sanofi pasteur co-exclusive rights in such Regulatory Documentation and Regulatory Approvals; and | ||
(d) | such other matters as the SC may consider appropriate. |
5.5.2 | Assignment of Regulatory Documentation . Emergent shall, at sanofi pasteurs cost, duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary to give effect to Clause 5.5.1(c). |
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5.5.3 | Transition Costs . All FTE Costs and Emergent Expenses incurred by Emergent in implementing each Transition Plan shall be paid by sanofi pasteur in accordance with Clause 5.13. | |
5.6 | The Late Development Phase | |
5.6.1 | Conduct . During the Late Development Phase each Party shall undertake the Development Activities allocated to it in the Development Plan and the relevant Annual Development Plan. It is anticipated that the majority of such Development Activities will be undertaken by sanofi pasteur. In particular, sanofi pasteur shall, with such assistance from Emergent as may be described in any Annual Development Plan, undertake further research and Development and Clinical Studies as described in the Later Stage Clinical Development Plan including all clinical, regulatory, manufacturing and other work that is required to conduct Phase II Studies and Phase III Studies and as may be necessary to obtain Marketing Authorisation for a Unitary Product in each Major Market Country. In addition to the reports to be provided pursuant to Clause 5.10, sanofi pasteur shall keep the Emergent Project Leader regularly updated as to progress under the Development Plan or any Annual Development Plan. | |
5.6.2 | Additional sanofi pasteur Responsibilities . The JPT shall be disbanded on the Transition Date or on such later date as the Parties may agree. Thereafter, except during such periods as the JPT is reconstituted pursuant to Clause 4.1, sanofi pasteur shall be responsible for proposing and submitting to the SC for review and, where required by this Agreement, approval as to: |
(a) | any amendments to the Development Plan or any Annual Development Plan including proposals relating to clinical, regulatory and intellectual property strategy, in each case as appropriate to the stage of the Development Programme; and | ||
(b) | any strategic issues relating to the Development Programme including the progression of Clinical Candidates and the Development of Combination Products. |
5.6.3 | Demonstration of Presence of SBAs . Subject to this Clause 5.6.3, sanofi pasteur shall commence a Clinical Study with a Clinical Candidate or Product to demonstrate the presence of SBAs in Adolescents within six (6) months of receipt of a final clinical study report demonstrating, in adults, the presence of SBAs in connection with use of a Clinical Candidate or Product. For the purpose of this Agreement, presence of SBAs will be deemed to have been demonstrated against Neisseria meningitidis serogroup B ( Demonstration of Presence of SBAs ), if a Programme Antigen or a Product (i) elicits a [**] fold increase in SBA Activity, as measured with a standard assay system, as identified in the Development Plan, which utilises human complement as the exogenous complement source, against at least [**] percent ([**]%) of a representative panel of Neisseria meningitidis serogroup B strains, in at least [**] percent ([**]%) of the subjects allocated to receive one test vaccine (i.e. at least one dosage with or without adjuvant) (the Response Rate ); and (ii) satisfies the safety endpoints of that Clinical Study with the very same formulation. Without prejudice to the generality of the foregoing, following the design of the relevant Clinical Study, the Steering Committee will agree the statistical analysis to be |
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performed on the Clinical Study results, including possible determination of the confidence intervals or other statistical measures for the Response Rate endpoint. If the Steering Committee agree statistical limits around the Response Rate endpoint and Demonstration of Presence of SBAs shall also be deemed to have occurred if the Clinical Study results are within these agreed limits and Clause 5.6.3 (ii) is also satisfied. If either the FDA or the European Agency for the Evaluation of Medicinal Products establishes a functional assay other than SBA Activity (an Alternative Assay ) as an alternative efficacy endpoint for the grant of a Marketing Authorisation for a Meningitis B Product, the Parties shall adopt such Alternative Assay and Demonstration of Presence of SBAs will be deemed satisfied if there is a successful demonstration of such functional activity using the Alternative Assay. | ||
5.7 | Incorporation of Additional Antigens | |
5.7.1 | Proposal to incorporate Additional Antigens . The Parties each acknowledge and agree that, although the primary objective of the Development Programme is to Develop a Product comprising only Programme Antigens, the effectiveness of a potential Product for the prevention of Neisseria meningitidis serogroup B may be enhanced by the incorporation of one or more Additional Antigens. Subject to Clause 5.8, sanofi pasteur may propose any such addition (and any corresponding amendments to the Development Plan) during the Early Development Phase or the Late Development Phase provided that sanofi pasteur is able to demonstrate that the proposed Additional Antigen satisfies the Inclusion Criteria. Any such proposal by sanofi pasteur shall be in writing and shall include all information required to determine whether the Additional Antigen satisfies the Inclusion Criteria and shall either be submitted to Emergent or, if sanofi pasteur is not prepared to disclose such information to Emergent, sanofi pasteur shall confirm that such information is available for review by an independent expert in accordance with Clause 5.7.2. Emergent shall within thirty (30) days from the date of such submission notify sanofi pasteur whether it agrees to the inclusion of such Additional Antigen or alternatively that it wishes the matter to be referred to an independent expert in accordance with Clause 5.7.2. If Emergent fails to provide such notice within such thirty (30) day period, Emergent shall be deemed to have consented to the incorporation of such Antigen into the Product or potential Product. | |
5.7.2 | Expert Review . If sanofi pasteur is unable to demonstrate to Emergents reasonable satisfaction that any proposed Additional Antigen satisfies the Inclusion Criteria, the Parties shall appoint an independent expert with expertise in the field of vaccine development and licensing reasonably acceptable to both Parties to determine whether the Antigen satisfies the Inclusion Criteria. If the Parties are unable to agree on the identity of the independent expert within ten (10) days of Emergents notifying sanofi pasteur that it desires the appointment of such expert, the independent expert shall be appointed by Emergent, and approved by sanofi pasteur, which approval shall not be unreasonably withheld, conditioned or delayed. Within twenty (20) days of such appointment, sanofi pasteur shall furnish to the expert (subject to such obligations of confidentiality and non-use as may be reasonably required by sanofi pasteur) all information necessary for the expert to make such determination with a copy to Emergent, provided that sanofi pasteur shall be entitled to redact sanofi pasteur Confidential Information from such copy. Emergent may also make submissions to the expert, with a copy to sanofi pasteur, within such period. Any such submission |
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shall not, unless the Parties otherwise agree, exceed 15,000 words. Within fifteen (15) days of receipt of the other Partys summary (or such longer period as may be required to ensure the presence of the expert), there shall be a one-day oral hearing before the expert at which each Party shall be given an equal opportunity to present its own position and hear and respond to the oral presentation given by the other Party. Within fifteen (15) days of such oral hearing each Party may submit a written rebuttal of the other Partys summary providing that any rebuttal shall not exceed 5,000 words. The expert shall be required by the Parties to use all reasonable efforts to render his decision within sixty (60) days of his appointment or if earlier within thirty days following his receipt of all such information and such decision shall be final and binding upon each of the Parties. Should the expert determine that the proposed Additional Antigen satisfies the Inclusion Criteria, then Emergent shall pay the fees and expenses of the expert. Should the expert determine that the proposed Additional Antigen does not satisfy the Inclusion Criteria, then sanofi pasteur shall pay the fees and expenses of the expert. | ||
5.7.3 | Non-discrimination . Whether or not any Additional Antigen satisfies the Inclusion Criteria, sanofi pasteur shall not in any event discriminate against any Programme Antigen and shall make all proposals and decisions relating to the prioritisation and screening of Antigens and the inclusion of any Antigen in a Unitary Product in good faith based on all available technical and scientific information. For the avoidance of doubt in making any such proposal or decision (including pursuant to Clause 3.5.1), sanofi pasteur shall not be entitled to take into account the royalties, milestones or other payments due or potentially due to Emergent with respect to any Programme Antigen or Product pursuant to this Agreement. | |
5.7.4 | sanofi pasteur activities with Programme Antigens . For the avoidance of doubt, sanofi pasteur shall not conduct any activities in relation to the Development of Programme Antigens unless such activities are set out in the Development Plan or any Annual Development Plan and are conducted in accordance with this Agreement as part of the Development Programme. | |
5.8 | Third Party Technology and sanofi pasteur Technology | |
5.8.1 | Independent review of Technology . Prior to the incorporation of any Third Party Antigen into a Product or application to a Product of any Patent Rights licensed to sanofi pasteur, sanofi pasteur shall disclose such Antigen or technology to Emergent and shall, upon Emergents request, allow an independent third party access to any relevant licenses granted to sanofi pasteur by Third Parties to verify the terms on which such Antigen or technology is licensed to sanofi pasteur (including any royalty obligations that would form part of the Royalty Burden). If sanofi pasteur incorporates or applies any such Antigen or technology in or to a Unitary Product the licence of such Antigen or technology to sanofi pasteur shall be deemed to be a sanofi pasteur In-Licence and Emergent will be provided with a schedule listing such sanofi pasteur In-License(s) and related Patent Rights. Except as expressly provided in Clause 7.4, no royalties or other consideration paid or payable by sanofi pasteur, its Affiliates or any Sub-Licensees to any Third Party pursuant to any sanofi pasteur In-Licence or any other licence shall be taken into consideration in the calculation of Net Sales hereunder or credited against any amounts owed by sanofi pasteur to Emergent hereunder. |
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5.8.2 | Disclosure of Technology . From time to time throughout the Term, sanofi pasteur shall disclose to Emergent any sanofi pasteur Independent Technology and sanofi pasteur Programme Technology necessary for the conduct of the Emergent Activities. | |
5.9 | Combination Products | |
Without prejudice to Clause 6.2, sanofi pasteur may at any time after commencement of the Late Development Phase propose Development of a Combination Product. In such event, whether or not there are, at that time, any ongoing Development Activities, any such Development shall be considered to be part of the Development Programme and the Late Development Phase shall be extended or revived as required. Without prejudice to its obligations under this Agreement, sanofi pasteur shall be entitled to make all strategic decisions relating to the Development of Combination Products; provided that sanofi pasteur shall promptly inform Emergent of any such decisions and shall provide such further information and explanation for such decision as Emergent may reasonably request. | ||
5.10 | Reports of Development Activities | |
During the Development Programme, each Party (acting through its Project Leader) shall furnish to the SC: |
(a) | within thirty (30) days after the end of each Quarter, summary reports describing its progress under the Annual Development Plan during that Quarter. The format and degree of detail required for such summary reports shall be defined and agreed by the SC with the objective of ensuring that each of the Parties provides an adequate amount of information to the other about its activities pursuant to the Annual Development Plan; and | ||
(b) | within sixty (60) days after the end of each Year or at such other times as the Parties may determine, comprehensive written reports describing in detail the work accomplished by it under the Annual Development Plan during such Year and discussing and evaluating the results of such work. |
5.11 | Performance by Emergent | |
In performing the Emergent Activities, Emergent shall use such FTEs as are specified in the relevant Annual Development Plan. Emergent shall notify the SC promptly upon becoming aware of a scientific or technical problem that is likely to preclude Emergent from completing any Emergent Activity with the FTEs set out in the applicable Annual Budget for such Emergent Activity. As part of such notification, Emergent shall provide the SC with a reasonably detailed description of such problem, together with its good faith belief as to the steps necessary to complete such Emergent Activity, if practicable at all, in light of such problem. Upon receipt of such notification, the SC shall then meet within ten (10) days to determine what action to take and Emergent shall not be required to perform the relevant Emergent Activity unless and until the SC resolves how to proceed. | ||
5.12 | Performance by sanofi pasteur | |
5.12.1 | Development of a Unitary Product . sanofi pasteur shall use Commercially Reasonable Efforts to Develop a Unitary Product. |
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5.12.2 | sanofi pasteur Diligence . sanofi pasteur warrants and undertakes that it shall at all times prior to the grant of a Marketing Authorisation for a Product in a Major Market Country have at least one Programme Antigen in active clinical Development provided that at least one Programme Antigen has met the Selection Criteria and provided further that: |
(a) | if all Programme Antigens have been tested in preclinical Development and none have met the Selection Criteria then sanofi pasteur will have no obligation to conduct clinical activities with any Programme Antigen and the absence of ongoing clinical activities by sanofi pasteur shall not constitute a lack of diligence; and | ||
(b) | if all Programme Antigens that have met the Selection Criteria have been tested in a Phase I Study, and none of the Programme Antigens that have met the Selection Criteria have been found to meet the Primary Inclusion Criteria, then sanofi pasteur will have no obligation to conduct further clinical activities with any such Programme Antigen and the absence of ongoing clinical activities by sanofi pasteur shall not constitute a lack of diligence. |
sanofi pasteur shall be deemed to be actively Developing at least one Programme Antigen if a Programme Antigen is in a Phase I Study, a Phase II Study or a Phase III Study. | ||
5.12.3 | Clinical Development . Without limiting the generality of Clause 5.12.2: |
(a) | sanofi pasteur shall use Commercially Reasonable Efforts to screen all Candidate Antigens to determine whether they meet the Selection Criteria; | ||
(b) | sanofi pasteur shall use Commercially Reasonable Efforts to progress into a Phase I Study any Programme Antigen that meets the Selection Criteria unless there is already a Programme Antigen in a Phase I Study or a later stage of active clinical Development; | ||
(c) | any Programme Antigen in a Phase I Study will be assessed to determine whether it satisfies the Primary Inclusion Criteria; | ||
(d) | subject to paragraph (e) below, sanofi pasteur shall use Commercially Reasonable Efforts to progress into a Phase II Study any Programme Antigen that meets the Primary Inclusion Criteria unless there is already a Product in a Phase II Study or a later stage of active clinical Development; | ||
(e) | provided that if sanofi pasteur has another Programme Antigen in a Phase I Study, sanofi pasteur shall not be obliged to include a Programme Antigen in a Meningitis B Product going into a Phase II Study if each of the Antigens included in that product are superior to that Programme Antigen or the combination of those Antigens is superior to all combinations of all or some of those Antigens with that Programme Antigen; | ||
(f) | if sanofi pasteur (or one of its Affiliates or Sub-Licensees) has a Competitive Product in a Phase II Study or later clinical development or a Competitive Product has been granted a Marketing Authorisation, any Programme Antigen |
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that satisfies the Primary Inclusion Criteria shall be assessed to determine (i) whether it is superior to one or more Sanofi Pasteur Antigens or Third Party Antigens included in that Competitive Product, or (ii) whether a combination of that Programme Antigen with one or more of those Sanofi Pasteur Antigens or Third Party Antigens is superior to the combination of Antigens in the Competitive Product. Superiority shall be determined in accordance with Clause 5.12.4. If it is determined that a Programme Antigen is superior to one or more Antigens included in the Competitive Product or would provide a superior combination of Antigens for use in a Meningitis B Product, sanofi pasteur must either (i) commence a Phase II Study with a Meningitis B Product including the superior Programme Antigen and, if applicable, the best combination of Antigens from the Competitive Product and thereafter actively continue the clinical Development of such Meningitis B Product; or (ii) notify Emergent in writing that it is not progressing a Meningitis B Product including the superior Programme Antigen and, if applicable, the best combination of Antigens from the Competitive Product into a Phase II Study or, if later, that it is suspending the further clinical Development of such Programme Antigen. On sanofi pasteur serving such notice or, if sanofi pasteur does not serve such notice and does not, within three (3) months from the date on which it is determined that the Programme Antigen is superior, commence development activities leading to the commencement of a Phase II Clinical Study with a Meningitis B Product including the superior Programme Antigen and, if applicable, the best combination of Antigens from the Competitive Product, or having commenced such activities suspends active clinical Development of such Programme Antigen, on Emergent serving written notice on sanofi pasteur, all rights in that Programme Antigen (the Repatriated Antigen ) shall revert to Emergent and Emergent shall be entitled to Exploit such Repatriated Antigen in and outside the Field; and | |||
(g) | if the Programme Antigen assessed pursuant to paragraph (f) above is not superior to the Antigens in the Competitive Product, sanofi pasteur shall be entitled to suspend further clinical Development of such Programme Antigen provided that, and for so long as, sanofi pasteur has another Programme Antigen in a Phase I Study or a later stage of active clinical Development. |
For the avoidance of doubt, sanofi pasteurs obligations in relation to the clinical Development of Programme Antigens shall cease on the grant of a Marketing Authorisation for a Product in a Major Market Country. | ||
5.12.4 | Superiority of Antigens . For the purposes of this Agreement, a Programme Antigen will be deemed to be superior to a sanofi pasteur Antigen or Third Party Antigen (as the case may be) if that Programme Antigen, had its characteristics been known at the time sanofi pasteur decided which Antigens would be included in the Competitive Product, would, applying the principles of non-discrimination set out in Clause 5.7.3, have been included standing alone or with other Antigens in a Meningitis B Product. The assessment of the relative superiority of Antigens shall be made on the basis of the same tests or assessments for each Antigen, including protection coverage against the same representative panel of clinically relevant Neisseria meningitidis serogroup B strains for each Antigen, immunogenicity, potential synergistic effects when in combination with other Antigens and the optimum protection coverage obtained with |
33
combinations of Antigens. The level of SBA or readout from any Alternative Assay considered to confer protection shall be applied equally to all Antigens. One Antigen shall not be considered superior to another on the basis of tests or assessments that may not be applied equally to both Antigens. Activities required to generate the data required to allow determination of the relative superiority of Antigens will be included in the Development Plan and Annual Development Plan and will be completed prior to the end of Phase I clinical development for the relevant Antigen. | ||
5.12.5 | Co-Exclusive Antigens . If prior to the grant of a Marketing Authorisation for a Product in a Major Market Country, sanofi pasteur suspends development of a Programme Antigen in accordance with Clause 5.12.3(g) and at the time of such suspension has or subsequently obtains a Marketing Authorisation for any Competitive Product, Emergent and sanofi pasteur shall have co-exclusive rights to Exploit such Programme Antigen (a Co-Exclusive Antigen ) unless sanofi pasteur has and continues to have a Product incorporating a Programme Antigen in a Phase II Study or later active clinical Development. A Co-Exclusive Antigen shall remain a Programme Antigen but once a Programme Antigen has become a Co-Exclusive Antigen it shall remain a Co-Exclusive Antigen even if sanofi pasteur subsequently commences a Phase II Study or any later clinical Development with it or a different Programme Antigen. | |
5.12.6 | Expert Determination . If sanofi pasteur is unable to demonstrate to Emergents reasonable satisfaction that a Programme Antigen is being Developed as required pursuant to this Clause 5.12, Emergent shall notify sanofi pasteur and the Parties shall appoint an independent expert with expertise in the field of vaccine development and licensure reasonably acceptable to both Parties to determine whether the Programme Antigen (i) satisfies the Selection Criteria and the Primary Inclusion Criteria; and (ii) is superior to any sanofi pasteur Antigen or Third Party Antigen in active clinical Development. If the Parties are unable to agree on the identity of the independent expert within ten (10) days of Emergent notifying sanofi pasteur that it wishes the appointment of such expert, the independent expert shall be appointed by Emergent, and approved by sanofi pasteur, which approval shall not be unreasonably withheld, conditioned or delayed. Within twenty (20) days of such appointment, each of the Parties shall furnish to the expert (subject to such obligations of confidentiality and non-use as may be reasonably required by them), with a copy to the other Party, a written summary of such Partys position and any relevant evidence supporting such position including all information necessary for the expert to make such determination. Any such written summary and evidence shall not, unless the Parties otherwise agree, exceed 15,000 words. Within fifteen (15) days of receipt of the other Partys summary (or such longer period as may be required to ensure the presence of the expert) there shall be a one-day oral hearing before the expert at which each Party shall be given an equal opportunity to present its own position and hear and respond to the oral presentation given by the other Party. Within fifteen (15) days of such oral hearing each Party may submit a written rebuttal of the other Partys summary providing that any rebuttal shall not exceed 5,000 words. The expert shall be required by the Parties to use all reasonable efforts to render his decision within thirty days following his receipt of all such summaries and information and such decision shall be final and binding upon each of the Parties. Should the expert find in favour of Emergent, then sanofi pasteur shall pay the fees and expenses of the expert. Should |
34
the expert find in favour of sanofi pasteur, then Emergent shall pay the fees and expenses of the expert. | ||
5.13 | Development Funding | |
sanofi pasteur shall pay Emergent (i) the aggregate FTE Cost for all FTEs, and (ii) the amount of all Emergent Expenses incurred by Emergent in accordance with the Indicative Cost Schedule, any Annual Budget or Transition Plan. On the date of this Agreement and on the first day of each subsequent Quarter, sanofi pasteur shall make a payment in pounds sterling (£) equal to the estimated FTE Cost and Emergent Expenses for the Quarter commencing on the Effective Date and thereafter each subsequent Quarter and, in relation to the payment to be made on the date of this Agreement, FTE Costs of £[**] and Emergent Expenses of £[**] incurred between 1 January 2006 and the Effective Date, as reflected in the then-current Indicative Cost Schedule, Annual Budget or Transition Plan provided that each such payment shall be made against an invoice issued by Emergent. Emergent acknowledges that sanofi pasteur may not be able to pay invoices received by sanofi pasteur in a particular month before the tenth day of the following month. Each of the Parties will use reasonable endeavours to ensure that invoices for each Quarter are issued at least one month prior to end of the immediately preceding Quarter to enable payment by sanofi pasteur against such invoice on or before the first day of each Quarter. Emergent shall provide sanofi pasteur with annual reconciliation statements that specify the actual number of FTEs and the actual Emergent Expenses for the last four (4) Quarters in the aggregate within sixty (60) days of the completion of each Year. If, with respect to a particular Year: |
(a) | the actual FTE Cost plus the Emergent Expenses specified in such annual reconciliation statement is less than the amount paid by sanofi pasteur to Emergent with respect to that Year, such excess shall be set against the amounts due to Emergent with respect to forthcoming Emergent Activities until such balance is zero or if no such activities are contemplated, repaid to sanofi pasteur; or | ||
(b) | the actual FTE Cost plus the Emergent Expenses specified in such annual reconciliation statement is more than the amount actually paid by sanofi pasteur to Emergent with respect to that Year, sanofi pasteur shall pay the deficiency within thirty (30) days of the date of such statement. |
5.14 | Funding Audit Rights | |
Emergent shall keep complete and accurate books and financial records pertaining to its costs and expenses of conducting the Emergent Activities (including duly completed Activity Forms), which books and financial records shall be retained by Emergent until three (3) years after the end of the Year to which they pertain. sanofi pasteur shall have the right to appoint at its expense an independent certified public accountant reasonably acceptable to Emergent to inspect and audit, during normal business hours and upon reasonable prior written notice, the books and financial records of Emergent relating to its costs and expenses of conducting the Emergent Activities during any Year; provided that sanofi pasteur shall not have the right to inspect or audit any Year more than once and will not go back over records more than three (3) years old unless a discrepancy is found. All books and financial records |
35
(a) | follow such Partys policies and procedures regarding reporting any invention, discovery, process, software programme, information, Know How or Material characterised, conceived, developed, derived, discovered, generated, identified or otherwise made by such person in the course of his or her employment or its retainer with such Party; | ||
(b) | assign to such Party all of his or her right, title and interest in and to any such invention, discovery, process, software program, information, Know How or Material characterised, conceived, developed, derived, discovered, generated, identified or otherwise made by such person in the course of his or her employment or its retainer with such Party, including any intellectual property or proprietary right thereto; | ||
(c) | co-operate in the preparation, filing, prosecution, maintenance, defence and enforcement of any Patent Rights claiming the same; and | ||
(d) | perform all acts and sign, execute, acknowledge and deliver any and all papers, documents and instruments required for effecting the obligations and purposes of that agreement. |
6. | COMMERCIALISATION OF PRODUCT | |
6.1 | Commercialisation Activities | |
Subject to the terms and conditions of this Agreement, sanofi pasteur shall have sole discretion over, and sole responsibility for, the Commercialisation of Products in the Territory including all decisions with respect to medical affairs, pricing, product launch, marketing, and sales activities. sanofi pasteur shall have sole responsibility for all costs and expenses in connection with such Commercialisation activities. sanofi pasteur shall conduct all Commercialisation activities in compliance in all |
36
material respects with all requirements of Applicable Law. | ||
6.2 | sanofi pasteur Diligence | |
sanofi pasteur shall use Commercially Reasonable Efforts: |
(a) | to Commercialise a Unitary Product in each Major Market Country; and | ||
(b) | if a Combination Product is Developed, to Commercialise such Combination Product in each Major Market Country. |
sanofi pasteur shall Commercialise each Product (whether a Unitary Product or a Combination Product) in accordance with the Commercialisation Plan for such Product. | ||
6.3 | Commercialisation Plan | |
No later than six (6) months prior to the anticipated date of submission to any Regulatory Authority in any Major Market Country of the first application for a Marketing Authorisation for any Product (whether a Unitary Product or a Combination Product), sanofi pasteur shall prepare and provide to Emergent a Commercialisation Plan for such Product. That Commercialisation Plan shall include the matters referred to in the Outline Commercialisation Plan. sanofi pasteur shall consider in good faith any comments made by Emergent. Each Commercialisation Plan shall be updated by sanofi pasteur and submitted to the SC as provided for in this Clause 6.3 not less than annually. Within thirty (30) days of the submission of any Commercialisation Plan or any amendment or update to a Commercialisation Plan, the SC shall, if so requested by Emergent, meet to review and consider that plan or amendment. | ||
6.4 | Commercialisation Reports | |
sanofi pasteur shall keep Emergent reasonably informed of the progress of sanofi pasteurs efforts to Commercialise any Product in the Field in the Territory through semi-annual reports, which reports shall summarise sanofi pasteurs efforts to Commercialise such Product in accordance with the Commercialisation Plan for such Product. | ||
6.5 | Development and Use of Trademarks | |
sanofi pasteur shall have the sole right, in its sole discretion (but in consultation with Emergent) to determine the Trademarks to be used with respect to any Product throughout the Territory (such Trademarks, the Product Trademarks ); provided however, that sanofi pasteur shall not, and shall not permit its Affiliates, to use in their respective businesses, any Trademark that is confusingly similar to, misleading or deceptive with respect to, or that dilutes any of the Trademarks used by Emergent or its Affiliates in their respective businesses. | ||
6.6 | Combination Products | |
Without prejudice to its obligations under this Agreement, sanofi pasteur shall be entitled to make all strategic decisions relating to the Commercialisation of |
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Milestone | |||||
Milestone Event | Payments | ||||
1 |
[**]
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[**] | |||
2 |
[**]
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[**] | |||
3 |
[**]
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[**] | |||
4 |
[**]
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[**] | |||
5 |
[**]
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[**] | |||
6 |
[**]
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[**] | |||
7 |
[**]
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[**] | |||
8 |
[**]
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[**] |
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Milestone | |||||
Milestone Event | Payments | ||||
9 |
[**]
|
[**] | |||
10 |
[**]
|
[**] | |||
11 |
[**]
|
[**] | |||
7.2.2 | Notice that a Milestone Event has Occurred and Payment . sanofi pasteur or Emergent (as the case may be) shall provide the other Party with prompt written notice upon each occurrence of a milestone event set out in Clause 7.2.1. On such occurrence, Emergent shall issue an invoice for the amount due and sanofi pasteur shall pay such within ten (10) days of the end of the calendar month in which it received such invoice. | |
7.2.3 | Milestone payments paid only once . For the avoidance of doubt (a) milestones 1 to 11 (inclusive) set forth in Clause 7.2.1 shall be payable no more than once, irrespective of the number of trigger events associated with any such given milestone and irrespective of whether the milestone is triggered by the activities of sanofi pasteur, its Affiliates or any Sublicensee; and (b) each of milestones 1 to 5 (inclusive) are payable prior to milestones 6 or 8 and if any of milestones 1 to 5 (inclusive) has not been paid when either milestone 6 or 8 becomes payable sanofi pasteur shall immediately pay such unpaid milestone. | |
7.2.4 | Definition . For the purpose of this Clause 7.2 an Efficacy and Effectiveness Study means a study designed and sufficiently powered to show that a vaccine candidate confers a reduction in the infection rate in cases per thousand or the reduction of clinical signs of confirmed serogroup B meningococcal disease in immunized populations (Efficacy) and demonstrates direct and indirect protection or any clinical benefit obtained in a vaccinated population (Effectiveness). | |
7.3 | Royalties | |
In consideration of the licences granted by Emergent to sanofi pasteur under Clause 8.1 and in recognition of Emergents contribution to the Development Programme and Emergents joint ownership with sanofi pasteur of the Joint Technology, sanofi pasteur shall, subject to the terms and conditions of this Agreement, pay Emergent on a country-by-country basis royalties in an amount equal to the following: |
(a) | [**] percent ([**]%) of, in the case of a Unitary Product, the aggregate Net Sales and, in the case of a Combination Product, the aggregate Adjusted Combination Net Sales, in each case in a country, provided that the Emergent Patent Rights or Joint Patent Rights in such country include at least one Valid Claim covering the Product; | ||
(b) | [**] percent ([**]%) of, in the case of a Unitary Product, the aggregate Net Sales and, in the case of a Combination Product, the aggregate Adjusted Combination Net Sales, in each case in any country in which the Exploitation of such Product would not infringe a Valid Claim of Emergent Patent Rights or Joint Patent Rights (or, for the avoidance of doubt, there are no Emergent Patent Rights or Joint Patent Rights); and |
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(c) | [**] percent ([**]%) of any license fees, upfront payments or milestones received by sanofi pasteur or any of its Affiliates from any Sub-Licensee provided that if a milestone is payable by such Sub-Licensee to sanofi pasteur or one of its Affiliates on the occurrence of one of the events listed in Clause 7.2.1, sanofi pasteur shall only be required to pay a royalty of [**] percent ([**]%) on the amount (if any) by which the milestone payable by the Sub-Licensee on such occurrence exceeds the amount payable by sanofi pasteur to Emergent on such occurrence pursuant to Clause 7.2.1. |
7.4 | Adjustment of Royalty Rate | |
7.4.1 | Royalty under Clause 7.3(a) . If a Unitary Product (whether developed and launched as a stand alone product or as a constituent of a Combination Product) contains one or more Additional Antigens, the royalty payable pursuant to Clause 7.3(a) shall be adjusted according to the number of Programme Antigens compared to the total number of Programme Antigens and Additional Antigens in such Unitary Product as follows: |
|
[**] | [**] | [**] | [**] | [**] | |||||||
Number
of
Programme Antigens in that Unitary Product |
[**] | [**] | [**] | [**] | [**] | [**] | ||||||
[**] | [**] | [**] | [**] | [**] | ||||||||
[**] | [**] | [**] | [**] | |||||||||
[**] | [**] | [**] | ||||||||||
[**] | [**] |
provided that, if the aggregate royalties payable by sanofi pasteur to (i) Emergent as set out in the table above; and (ii) any Third Party pursuant to a sanofi pasteur In-Licence on the sale of the Unitary Product (whether sold as a stand alone product or as a constituent of a Combination Product) in the relevant country if and to the extent that such royalty is payable for access to a Third Party Antigen in the Unitary Product or any adjuvant or for access to any technology necessary or reasonably useful for the manufacture of any Programme Antigen or Additional Antigen incorporated in such Unitary Product but, for the avoidance of doubt, excluding any technology relating to delivery of the Product, ((i) and (ii) in aggregate, the Royalty Burden ) are equal to or less than [**] percent ([**]%) of Net Sales of such Unitary Product or, if the Unitary Product is sold as a constituent of a Combination Product, [**] percent ([**]%) of Adjusted Combination Net Sales of such Combination Product, the royalty payable to Emergent pursuant to Clause 7.3(a) shall not be less than [**] percent ([**]%). If on a recalculation of the Royalty Burden to include such increased royalty to Emergent the Royalty Burden would be more than [**] percent ([**]%), such royalty shall be reduced so that the Royalty Burden calculated to include the revised royalty payable to Emergent equals [**] percent ([**]%). For the avoidance of doubt, the royalty payable to Emergent pursuant to Clause 7.3(a) shall not in any event be less than the applicable amount provided for in the royalty grid in this Clause 7.4.1. The Royalty Burden shall be calculated at the time of the relevant sale of the Unitary |
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Product or the Combination Product (as the case may be) and no specific royalty shall be counted more than once. | ||
7.4.2 | Royalty under Clause 7.3(b) . If a Unitary Product (whether developed and launched as a stand alone product or as a constituent of a Combination Product) contains one or more Additional Antigens the royalty payable pursuant to Clause 7.3(b) shall be adjusted according to the number of Programme Antigens compared to the total number of Programme Antigens and Additional Antigens in that Unitary Product as follows: |
|
[**] | [**] | [**] | [**] | [**] | |||||||
Number
of
Programme Antigens in that Unitary Product |
[**] | [**] | [**] | [**] | [**] | [**] | ||||||
[**] | [**] | [**] | [**] | [**] | ||||||||
[**] | [**] | [**] | [**] | |||||||||
[**] | [**] | [**] | ||||||||||
[**] | [**] |
provided that, if the Royalty Burden is equal to or less than [**] percent ([**]%) of Net Sales of such Unitary Product, or, if such Unitary Product is sold as a constituent of a Combination Product, [**] percent ([**]%) of Adjusted Combination Net Sales of such Combination Product, the royalty payable to Emergent pursuant to Clause 7.3(b) shall not be less than [**] percent ([**]%). If on a recalculation of the Royalty Burden to include such increased royalty to Emergent the Royalty Burden would be more than [**] percent ([**]%), such royalty shall be reduced so that the Royalty Burden calculated to include the revised royalty payable to Emergent equals [**] percent ([**]%). For the avoidance of doubt, the royalty payable to Emergent pursuant to Clause 7.3(b) shall not in any event be less than the applicable amount provided for in the royalty grid in this Clause 7.4.2. | ||
7.4.3 | Minimum Royalties for Combination Products . If the Product is sold as a Combination Product, the royalty payable to Emergent pursuant to Clause 7.3 (as adjusted pursuant to Clause 7.4.1 or Clause 7.4.2, if applicable) shall be subject to a minimum as set out in the definition of Net Sales. | |
7.4.4 | Verification of Royalty Burden . If at any time during the Term, either or both Clauses 7.4.1 or 7.4.2 apply to reduce the royalty payable pursuant to Clause 7.3, Emergent shall be entitled to appoint an independent Third Party to verify the applicable Royalty Burden. sanofi pasteur shall provide such Third Party with all information necessary for him to verify the applicable Royalty Burden including access to any agreements pursuant to which a royalty included in the Royalty Burden is payable and any other information necessary to explain or verify the amount of such royalty with respect to any country at the relevant time. All agreements and information made available for inspection shall be deemed to be sanofi pasteur Confidential Information. For the avoidance of doubt, any such Third Party shall prior to such inspection enter into a non-disclosure agreement in a form reasonably |
41
acceptable to sanofi pasteur. The Third Party shall disclose to the Parties the correct Royalty Burden for the relevant country at the relevant time and the specific details concerning any discrepancy with sanofi pasteurs calculation of the Royalty Burden but no other information shall be provided to Emergent. | ||
7.4.5 | Worked Examples . The Parties have set forth in Schedule 10 illustrative examples of the calculation of royalties that would be payable on Unitary Products and Combination Products in certain circumstances pursuant to Clauses 7.3 and 7.4. | |
7.5 | Royalty Term | |
sanofi pasteurs obligation to pay royalties to Emergent under Clause 7.3 on Net Sales shall terminate, on a country-by-country basis, with respect to any Product on the later to occur of (i) the [**] anniversary of the First Commercial Sale in such country; and (ii) the expiration date in such country of the last to expire of any Emergent Patent Rights or Joint Patent Rights that include at least one Valid Claim covering such Product in such country. Upon termination of the royalty obligations of sanofi pasteur under this Clause 7.5 in a country, the licence grants to sanofi pasteur in Clause 8.1 shall become non-exclusive, irrevocable and fully paid-up with respect to such country and Net Sales of such Product in such country shall be excluded from the royalty calculations set out in Clause 7.3. | ||
7.6 | Royalty Statements | |
7.6.1 | Written Reports . During the Term, following the First Commercial Sale, sanofi pasteur shall on or before the thirtieth (30th) day following the end of each Quarter deliver to Emergent a written report for that Quarter showing, in each case on a country-by-country basis: |
(a) | invoiced sales, Net Sales and, if applicable, Adjusted Combination Net Sales (including the calculation of Adjusted Combination Net Sales); | ||
(b) | the number of units of Product sold; | ||
(c) | if there has been any adjustment to the royalty rate pursuant to Clause 7.4, the basis and calculation of such adjustment and a breakdown of the Royalty Burden; | ||
(d) | the amount of royalties due on such Net Sales or Adjusted Combination Net Sales (calculated in accordance with GAAP and Clauses 7.3 and 7.4); and | ||
(e) | all license fees, upfront payments or milestones received by sanofi pasteur or any of its Affiliates from any Sub-Licensee and the amount payable pursuant to Clause 7.3(c). |
7.6.2 | Invoices . sanofi pasteur shall, at the same time as it delivers each written report required by Clause 7.6.1, submit to Emergent a model form invoice for the amount of royalties shown in each such written report to be due. Emergent shall issue an invoice for the royalties payable according to such written report and such model form invoice. sanofi pasteur acknowledges and agrees that all such invoices shall be issued by Emergent in reliance on the information provided by sanofi pasteur. Neither the |
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issue of any such invoice nor receipt of payment, shall be, nor shall either be deemed to be, acceptance by Emergent of the accuracy of any written report and shall in each case be without prejudice to Emergents rights to audit or dispute the amount of royalties payable. | ||
7.6.3 | Payments . sanofi pasteur shall, within ten (10) days of the end of the month in which it receives the relevant invoice in accordance with Clause 7.6.2, pay to Emergent or, if not prohibited by law, to whomsoever Emergent shall direct in writing (provided that, for the avoidance of doubt, the provisions of Clause 7.9.1 shall continue to apply to any payment to any such designee and sanofi pasteur shall not be required to incur any additional cost as a result of a payment to any such designee), in Euros to a bank designated in writing by Emergent (such designation to include relevant wiring instructions), or in such other manner as may be agreed between the Parties from time to time, the amount stated in such invoice. | |
7.6.4 | Currency Conversions . Where the Product is sold in a currency other than Euros all amounts payable will first be calculated in the currency of sale and then converted by sanofi pasteur into Euros at the mid-market exchange rate(s) quoted by Barclays Bank plc in London (or such other bank as the Parties may agree from time to time) for Euros in exchange for that other currency on the final day of the period to which the payment relates. | |
7.7 | Records and Audits | |
7.7.1 | Records . sanofi pasteur shall keep, and shall cause its Affiliates and Sub-Licensees to keep, complete and accurate books and financial records containing all data necessary for the calculation of the amounts payable by sanofi pasteur pursuant to this Agreement including with respect to the calculation and actual payment of the Royalty Burden, which books and financial records shall be kept in accordance with GAAP and shall be retained by sanofi pasteur, and its Affiliates and Sub-Licensees as appropriate, until three (3) years after the end of the Year to which they relate. | |
7.7.2 | Audit Procedure . Upon the written request of Emergent, sanofi pasteur shall permit an independent certified public accounting firm of internationally recognised standing selected by Emergent, and reasonably acceptable to sanofi pasteur, to inspect and audit, during normal business hours and upon reasonable prior written notice, such of the records of sanofi pasteur as may be reasonably necessary to verify the accuracy of the reports provided in accordance with Clause 7.6; provided that Emergent shall not have the right to inspect or audit records for any Year more than once or records more than three (3) years old unless a discrepancy is found. If such accounting firm concludes that sanofi pasteur owed additional amounts to Emergent during such period, sanofi pasteur shall pay Emergent the difference between the amount actually owed, as determined by the accounting firm, and the amount actually paid by sanofi pasteur, with interest calculated in accordance with Clause 7.8 from the date originally due to the date of payment, within thirty (30) days after the date on which such accounting firms written report is delivered to sanofi pasteur. If the accounting firm determines that there has been an underpayment, sanofi pasteur shall bear all costs related to such audit otherwise Emergent shall bear the cost of such audit. All books and financial records made available for inspection or audit shall be deemed to be sanofi pasteur Confidential Information. For the avoidance of doubt, any such independent accounting firm shall, prior to such inspection, enter into a non- |
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disclosure agreement in a form reasonably acceptable to sanofi pasteur. The accounting firm shall disclose to the Parties whether nor not the payment in question was accurately calculated by sanofi pasteur and the specific details concerning any discrepancies but no other information shall be provided to Emergent. | ||
7.7.3 | Access to Sub-Licensees . sanofi pasteur shall include in each sub-licence granted by it pursuant to this Agreement a provision requiring the Sub-Licensee to make reports to sanofi pasteur, to keep and maintain records of sales made pursuant to such sub-licence and to grant access to such records by Emergents independent accountant to the same extent required of sanofi pasteur under this Agreement. | |
7.8 | Interest | |
All amounts due from sanofi pasteur to Emergent under this Agreement shall be paid by wire transfer in immediately available funds to an account designated by Emergent. Any payment that is not paid on the date such payment is due under this Agreement shall bear interest at a rate equal to the lesser LIBOR plus two (2) percentage points and the maximum rate permitted by law, calculated on the number of days such payment is delinquent, compounded monthly. For the purposes of this Agreement LIBOR shall mean the London Interbank Offered Rate as calculated by the British Bankers Association or, if LIBOR ceases to be available, the base rate of a London bank selected by Emergent. | ||
7.9 | Withholding | |
7.9.1 | Payments . Any consideration payable by either Party shall be paid free and clear of any deduction or withholding for or on account of tax, setoffs or counterclaims whatsoever, save for any deduction or withholding required by Applicable Law. Where such a deduction or withholding is required to be made, the Party making the deduction or withholding shall give the other Party such assistance as may be necessary or expedient to enable that other Party to claim exemption therefrom or a reduction thereof and upon request of such other Party shall provide documentation in a form sufficient to evidence the payment of the tax. Such assistance shall include the provision by sanofi pasteur to Emergent of such forms as the relevant tax authority may require Emergent to complete. | |
7.9.2 | Information to be provided by Emergent . Emergent shall complete and return to sanofi pasteur any form provided by sanofi pasteur that is required by the relevant tax authorities from time to time (including, if required, prior to the first payment in any calendar year) to (i) attest Emergents fiscal residence and (ii) obtain the application of the reduced withholding tax rate or the exemption of withholding tax rate, according to the relevant bilateral convention for the prevention of double taxation. In the event that Emergent fails to return to sanofi pasteur such forms duly completed and signed before the due date for the relevant payment, sanofi pasteur will, if and to the extent required by Applicable Law, declare and pay withholding tax at the rate prescribed by Applicable Law, and such tax will be deducted from the amount payable by sanofi pasteur to Emergent. sanofi pasteur shall remit the withholding tax to the proper tax authority and proof of payment of such tax shall be secured and sent to Emergent as evidence of such payment; provided, however, that Emergent may, at any time prior to a payment due date, specify a later due date for payment, and sanofi pasteur shall delay making such payment to such later due date (without incurring any liability |
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pursuant to Clause 7.8), in order to provide Emergent with additional time in which to obtain the required information or otherwise secure approval for exemption of withholding tax or reduction of the withholding tax rate. | ||
7.10 | VAT | |
If VAT is payable on any supply by either Party under this agreement, the Party receiving the supply shall, in addition to any consideration due hereunder with respect to such supply, promptly pay to the Party making the supply the amount of such VAT upon receipt of a valid VAT invoice in the prescribed form with respect to such supply. | ||
7.11 | Changing Standards | |
Each Party shall consider in good faith, and not unreasonably refuse, any request by the other Party to modify any reporting requirements or provisions relating to records as set out in this Agreement in a manner necessary to permit the requesting Party to comply with any reporting or financial standards applicable to it or its Affiliates from time to time. | ||
8. | LICENCE GRANTS | |
8.1 | Emergent Licence Grants | |
8.1.1 | Licence under Emergent Technology . Subject to the terms of this Clause 8.1.1 and the other terms of this Agreement, Emergent hereby grants to sanofi pasteur an exclusive (even as to Emergent) worldwide licence during the term of this Agreement in the Territory in the Field, with the right, subject to Clause 8.1.3, to grant sub-licences, under the Emergent Technology and Emergents right and interest in Joint Technology: |
(a) | to research and Develop any Programme Antigen; and | ||
(b) | to Exploit any Product; |
provided that (i) no Product shall include, and Emergent grants no rights to Exploit, any Terminated Antigen or Repatriated Antigen; and (ii) Emergent expressly reserves for itself such rights as may be necessary or reasonably useful to (A) perform the tasks assigned to it in the Development Plan and any Annual Development Plan and to conduct the Emergent Activities in accordance with this Agreement; (B) Exploit any Terminated Antigen outside the Field; (C) Exploit any Repatriated Antigen in or outside the Field; and (D) Exploit any Co-Exclusive Antigen in or outside the Field provided that such rights shall, in the Field, be co-exclusive with sanofi pasteur. For the avoidance of doubt, sanofi pasteur shall have no right to research, Develop or otherwise Exploit any Terminated Antigen or Repatriated Antigen, and Emergent will have no right to research, Develop or otherwise Exploit any Terminated Antigen in the Field. | ||
8.1.2 | Regulatory Documentation . Subject to the other terms of this Agreement, Emergent and its Affiliates hereby grant to sanofi pasteur and its Affiliates a co-exclusive (with Emergent and its Affiliates) licence and right of reference in the Territory during the |
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term of this Agreement, with the right to grant sub-licences subject to Clause 8.1.3, under Emergents rights and interests in the Regulatory Documentation for or relating to any Clinical Candidate or Product to the extent not otherwise assigned pursuant to Clause 5.5.2 so as to enable sanofi pasteur to exercise its rights under the grants set out in Clause 8.1.1. Emergent shall, as soon as reasonably practicable following sanofi pasteurs written request, provide sanofi pasteur with access to all such Regulatory Documentation and all information contained therein. | ||
8.1.3 | Right to Sublicense . sanofi pasteur shall be entitled to grant sublicences under the rights granted pursuant to Clause 8.1.1 and 8.1.2 subject to Emergents prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. In the event that sanofi pasteur wishes to obtain Emergents consent to a proposed sublicence pursuant to Clause 8.1.1 or Clause 8.1.2, sanofi pasteur shall provide written notice to Emergent of the proposed sublicence at least thirty (30) days prior to its execution and provide copies to Emergent of each such sublicence with the financial terms redacted but otherwise substantially in the form to be executed at least ten (10) Business Days prior to such execution. Within ten (10) Business Days of execution of such sublicence, sanofi pasteur shall provide a copy of the sublicence in the form executed. For the avoidance of doubt, any such sublicence shall be consistent with the terms of this Agreement (including with regard to audit rights and confidentiality) and shall not relieve sanofi pasteur of its obligations pursuant to this Agreement. Sub-Licensees shall not be entitled to grant further sublicenses under the Emergent Technology or Joint Technology. | |
8.2 | Materials | |
Emergent hereby grants to sanofi pasteur the right to use Materials provided by Emergent to sanofi pasteur pursuant to this Agreement provided that any such Materials including any replication, copy, progeny or derivative thereof and any Materials derived from such Materials (the Emergent Materials ), shall be used solely for the Development Activities as provided in the Development Plan or any Annual Development Plan and in compliance with Applicable Law. sanofi pasteur shall not make any Emergent Materials available to any Third Party without Emergents prior written consent. Any Emergent Materials are provided subject to Clause 12.2 and all right, title and interest in and to any such Emergent Materials shall be, and remain, vested in Emergent. | ||
8.3 | sanofi pasteur Licence Grants | |
8.3.1 | Development . Subject to the other terms of this Agreement, sanofi pasteur and its Affiliates hereby grant to Emergent and its Affiliates a non-exclusive (with sanofi pasteur), royalty-free, worldwide licence, without the right to grant sub-licences (except as necessary or reasonably useful in connection with any engagement by Emergent of a Third Party to conduct any Emergent Activity as provided for in any Annual Development Plan), under the sanofi pasteur Technology and sanofi pasteurs right and interest in the Joint Technology solely to conduct Emergent Activities. | |
8.3.2 | Repatriated Antigens and Co-Exclusive Antigens . Subject to the other terms of this Agreement, sanofi pasteur and its Affiliates hereby grant to Emergent and its Affiliates (a) an exclusive, royalty-free, worldwide licence, with the right to grant sub-licences under sanofi pasteurs right and interest in the Joint Technology to |
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Parties otherwise agree, exceed 15,000 words. Within fifteen (15) days of receipt of the other Partys summary (or such longer period as may be required to ensure the presence of the expert) there shall be a one-day oral hearing before the expert at which each Party shall be given an equal opportunity to present its own position and hear and respond to the oral presentation given by the other Party. Within fifteen (15) days of such oral hearing, each Party may submit a written rebuttal of the other Partys summary providing that any rebuttal shall not exceed 5,000 words. The expert shall determine inventorship and ownership of such Technology in accordance with this Agreement. The decision of such outside patent counsel shall be final and binding on the Parties. In the event the independent outside patent counsel rules in favour of sanofi pasteurs position then Emergent shall pay the fees and expenses of the expert, and in the event that the independent outside patent counsel rules in favour of Emergents position then sanofi pasteur shall pay the fees and expenses of the expert. | ||
9.1.5 | Disclosure. During the Development Programme, each Party shall promptly disclose, and shall cause its Affiliates and sub-licensees to disclose, to the other Party in writing the characterisation, conception, development, derivation, discovery, generation, identification or making of any Technology in the course of work conducted under or in connection with this Agreement. | |
9.1.6 | Assignment . Each Party shall, and does hereby, assign, and shall cause its Affiliates, sub-contractors and sub-licensees to so assign, to it or to the other Party, as applicable, without additional compensation, such right, title and interest in and to any Know How, Patent Rights or other intellectual property, as is necessary to fully effect the ownership provisions set out in this Clause 9.1. | |
9.1.7 | Registration and Protection of Trademarks . sanofi pasteur shall have the sole right, at its sole cost and expense, to obtain, maintain, register, extend, enforce and defend trademark protection for all Product Trademarks. | |
9.2 | Filing, Prosecution and Maintenance of Patent Rights | |
9.2.1 | Emergent Patent Rights . Emergent shall have the first right (but not the obligation) to prepare, file, prosecute and maintain the Emergent Patent Rights. Emergent shall diligently file and prosecute claims relating to Clinical Candidates in the countries specified in Schedule 9. Emergent shall provide sanofi pasteur at least once per Year with an updated list of the patents and patent applications comprising the Emergent Patent Rights. Emergent shall also notify sanofi pasteur of the lapse, revocation, surrender or abandonment of any patent or patent application included among the Emergent Patent Rights. | |
9.2.2 | sanofi pasteur Patent Rights . sanofi pasteur shall have the first right (but not the obligation) to prepare, file, prosecute and maintain the sanofi pasteur Patent Rights throughout the Territory, in its sole discretion. In the event that sanofi pasteur shall grant Emergent a license to sanofi pasteur Patent Rights pursuant to Clauses 14.3.1 or 14.3.2 then sanofi pasteur shall provide Emergent with a list of all patents and patent applications comprising sanofi pasteur Patent Rights. | |
9.2.3 | Joint Patent Rights . Decisions regarding the preparation, filing, prosecution and maintenance of the Joint Patent Rights shall be made by the SC. Upon the identification of Joint Technology the SC shall: (i) promptly discuss such Joint |
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Technology; (ii) promptly discuss the desirability of filing patent application(s) covering such Joint Technology, and the relevant countries for filing which shall in any event include those countries listed in Schedule 9; and (iii) make the final decision with respect to any such filings as soon as practicable. Thereafter, sanofi pasteur, at its expense and through patent attorneys or agents of its choice and reasonably acceptable to Emergent, shall prepare, file, prosecute and maintain the Joint Patent Rights provided that Emergent shall at sanofi pasteurs request and expense make such filings and take such other actions in relation to the prosecution and maintenance of the Joint Patent Rights as the SC considers appropriate from time to time. Such applications shall be filed expeditiously at the appropriate time in all countries listed in Schedule 9 and all other countries in which the SC determines patent protection is necessary or desirable. sanofi pasteur shall not abandon any such application for patent or permit any patent issuing therefrom to lapse in a country listed in Schedule 9 without Emergents prior written consent. |
9.2.4 | Consultation . Each Party (in this paragraph, the Controlling Party ) shall regularly provide the other Party with copies of all patent applications to be filed by it under Clause 9.2 and other material submissions and correspondence with any patent authorities, as applicable, in sufficient time to allow for review and comment by the other Party. In addition, to the extent practicable, the Controlling Party shall provide the other Party and its counsel with an opportunity to consult with the Controlling Party and its counsel regarding the filing and contents of any application, amendment, registration, submission, response or correspondence with any patent authorities with respect to, and the Controlling Party shall consider in good faith the reasonable requests of the other Party regarding the filing and prosecution of such Patent Rights. | |
9.2.5 | Election not to File, Prosecute or Maintain . If a Party elects not (i) to pursue in any country in the Territory the filing, prosecution or maintenance of Patent Rights in respect of which it has the first right or obligation to file, prosecute or maintain pursuant to Clauses 9.2.1, 9.2.2, 9.2.3 or 9.2.4, or (ii) to take any other action with respect to such Patent Rights in a country in the Territory that is necessary or useful to establish or preserve rights thereto, then such Party shall so notify the other Party promptly in writing to enable the other Party to meet any deadlines by which an action must be taken to establish or preserve a right in such Patent Rights, as applicable, in such country. The Party receiving such notice shall have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution or maintenance, of such Patent Rights in such country through patent attorneys or agents of its choice and reasonably acceptable to the other Party. If the Party receiving such notice elects to pursue such filing or registration, as the case may be, or to continue such support, then such Party shall notify the other Party of such election and the other Party shall, and shall cause its Affiliates to, reasonably cooperate with such Party in this regard. If Emergent elects to pursue the filing or registration, or support the continued prosecution or maintenance of Joint Patent Rights in a country other than a Major Market Country and sanofi pasteur subsequently Commercialises a Product in such country, sanofi pasteur shall reimburse Emergent for all out-of-pocket costs and expenses incurred in filing, prosecuting or maintaining such Patent Rights in such country. For clarity, sanofi pasteur shall not be entitled to make an election pursuant to this Clause 9.2.5 with respect to Joint Patent Rights in any Major Market Country. |
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9.3 | Enforcement of Patent Rights | |
9.3.1 | Notification of Infringement . If either Party learns of any infringement or threatened infringement by a Third Party of the sanofi pasteur Patent Rights, the Emergent Patent Rights or the Joint Patent Rights, such Party shall promptly notify the other Party and shall provide such other Party with any available evidence of such infringement. | |
9.3.2 | Enforcement . |
(a) | In the event of any infringement of an Emergent Patent Right, a sanofi pasteur Patent Right or a Joint Patent Right in the Territory, sanofi pasteur shall have the first right, but not the obligation, to attempt to remove such infringement by commercially appropriate steps, including filing an infringement suit or taking other similar action. If required by Applicable Law in order for sanofi pasteur to prosecute such suit, Emergent shall join such suit as a party, and sanofi pasteur shall reimburse Emergent on a Quarterly basis for reasonable out-of-pocket costs and expenses incurred by Emergent with respect to such joinder. | ||
(b) | If sanofi pasteur fails within three (3) months following notice of infringement to take commercially appropriate steps to remove such infringement in accordance with paragraph (a) above, then Emergent shall have the right to attempt to remove such infringement; provided, however, that if sanofi pasteur has commenced negotiations with an alleged infringer for discontinuance of such infringement within such three-month period, sanofi pasteur shall have an additional period of three (3) months to conclude its negotiations before Emergent may bring suit for such infringement. | ||
(c) | The Party not enforcing the applicable Patent Rights shall provide reasonable assistance to the other Party, including providing access to relevant documents and other evidence and making its employees available at reasonable business hours, subject, if the enforcing Party is sanofi pasteur, to reimbursement to Emergent on a Quarterly basis of any reasonable out-of-pocket costs and expenses incurred by Emergent. Any damages or other monetary awards recovered pursuant to this Clause 9.3.2 shall be allocated first to the costs and expenses of the Parties. Any amounts remaining shall be deemed to be [**]. |
9.3.3 | Settlement with a Third Party . The Party that controls the prosecution of a claim with respect to any Patent Right shall also have the right to control settlement of such claim; provided, however, that no settlement shall be entered into without the written consent of the other Party if such settlement would materially adversely affect the interests of such other Party. Any amount paid by a Third Party pursuant to this Clause 9.3.3 shall be allocated first to the costs and expenses of the Parties. Any amounts remaining shall be deemed to be [**]. | |
9.4 | Infringement of Third Party Rights | |
9.4.1 | Third Party Infringement Suit . In the event that a Third Party institutes a Patent Right infringement suit against sanofi pasteur or Emergent during the term of this Agreement, alleging that the Exploitation of a Programme Antigen or Product in |
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accordance with this Agreement without the prior written consent of the Disclosing Party, except for any part of the Confidential Information which: |
(a) | is known to the Receiving Party prior to the date of first disclosure by the Disclosing Party as evidenced by written record or other proof; | ||
(b) | is or shall become in the public domain through no breach of this Agreement; | ||
(c) | is acquired lawfully by the Receiving Party from a Third Party that has no confidentiality obligation to the Disclosing Party; or | ||
(d) | has been independently discovered or developed (as demonstrated by contemporaneous written or electronic evidence maintained in the ordinary course of business of the Receiving Party) by employees or agents of the Receiving Party without access to, or use of, Confidential Information disclosed by the Disclosing Party to the Receiving Party. |
Specific aspects or details of Confidential Information shall not be deemed to be in the public domain or in the possession of a Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of such Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of a Party merely because individual elements of such Confidential Information are in the public domain or in the possession of such Party unless the combination and its principles are in the public domain or in the possession of such Party. | ||
10.2 | Confidentiality of Unpatented Joint Technology | |
Each Party shall treat all unpatented Joint Technology as strictly confidential and shall not disclose the same to any Third Party except to the extent that it is or shall become public knowledge through no fault on its part and neither Party shall use such Joint Technology except in connection with the Development and Commercialisation of a Product in accordance with this Agreement. | ||
10.3 | Exceptions | |
Notwithstanding the terms of Clauses 10.1 and 10.2 each Party may disclose any information and data in respect of which it is restricted pursuant to either Clause: |
(a) | to its employees but only on a need to know basis provided each such employee enters into a confidentiality agreement at least as restrictive with respect to the Confidential Information as this Clause 10; or | ||
(b) | to Affiliates, permitted sub-licensees and sub-contractors and their respective employees (but only on a need to know basis) and Third Party consultants, scientific and clinical investigators and others (in each case, subject to such persons entering into a confidentiality agreement at least as restrictive with respect to the Confidential Information as this Clause 10) where reasonably necessary for carrying out the purposes of this Agreement or, in the case of Affiliates and such Affiliates employees, for the conduct of its, or such Affiliates, business; |
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(c) | on a need to know and confidential basis to its, or its Affiliates, legal and financial advisors to the extent such disclosure is reasonably necessary in connection with such Partys activities as expressly permitted by this Agreement or for the conduct of its, or such Affiliates, business; | ||
(d) | to a prospective assignee pursuant to Clause 19.1 and such Third Partys employees, advisors, representatives, Affiliates, partners, members, shareholders and financing sources in each case on a need to know basis and subject to such persons entering into a confidentiality agreement at least as restrictive with respect to the Confidential Information as this Clause 10 (except that the obligations under such confidentiality agreement shall terminate five (5) years after disclosure of the relevant Confidential Information to such assignee or other Third Party); | ||
(e) | to any Regulatory Authority or government agency or authority to the extent such disclosure is useful or reasonably necessary to achieve the purposes of this Agreement or to any taxing or other authority competent to impose, administer or collect taxation to the extent such disclosure is useful or reasonably necessary; and | ||
(f) | as required by Applicable Law, the rules or regulations of a relevant stock exchange or similar governing body (including the U.S. Securities and Exchange Commission) or an order of any government agency, department or court; provided that: |
(i) | to the extent permitted prompt written notice of the disclosure shall be given to the Disclosing Party; | ||
(ii) | such disclosure shall be only to the extent so required; | ||
(iii) | if permitted, and to the extent reasonably practicable, written notice of the requirement shall be given to Disclosing Party and the Parties shall discuss the timing and content of such disclosure with a view to preventing or minimising loss of confidentiality for the material; and | ||
(iv) | insofar as material so required to be disclosed is not made public, the obligation of confidentiality hereunder shall continue to apply to it. |
10.4 | Survival of Confidentiality Requirements | |
The obligations of the Parties under Clauses 10.1 to 10.3 shall survive the expiration or termination of this Agreement for whatever reason for a period of five (5) years to the extent the Confidential Information or the unpatented Joint Technology remains confidential; provided that in the event that either Party remains entitled to use the unpatented Joint Technology after the expiration or termination of this Agreement, that Party shall be entitled to disclose the unpatented Joint Technology to a Third Party to the extent that such disclosure is necessary to that Partys effective exercise of such entitlement. | ||
10.5 | Injunctive Relief |
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The Parties understand and agree that remedies in damages may be inadequate to protect against any breach of any of the provisions of this Clause 10 by either Party or their employees, officers and any other person acting in concert with it or on its behalf. Accordingly, each Party shall be entitled to the granting of interim and final injunctive relief by a court of competent jurisdiction in the discretion of that court against any action that constitutes any breach of this Clause 10. | ||
10.6 | Use of Name | |
Neither Party shall mention or otherwise use the name, symbol, trademark, trade name or logotype of the other Party (or any abbreviation or adaptation thereof) in any publication, press release, promotional material or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Clause shall not prohibit either Party from making any disclosure identifying the other Party that is required by Applicable Law. | ||
10.7 | Publications and Presentations | |
During the term of this Agreement, each Party shall submit to the other Party (the Non-Publishing Party ) for review and approval all proposed academic, scientific and medical publications and public presentations relating to any aspect of the Development Programme or to any Programme Antigen or any Product. Such review and approval shall be conducted for the purposes of preserving intellectual property protection and determining whether any portion of the proposed publication or presentation containing the Confidential Information of the Non-Publishing Party or the unpatented Joint Technology should be modified or deleted. Written copies of such proposed publications and presentations shall be submitted to the Non-Publishing Party no later than sixty (60) days before submission for publication or presentation. The Non-Publishing Party shall provide its comments, if any, and (if it so chooses) its approval within thirty (30) days of its receipt of such written copy. The review period may be extended for an additional sixty (60) days upon request of the Non-Publishing Party in the event the Non-Publishing Party can demonstrate reasonable need for such extension, including the preparation and filing of patent applications. By mutual written agreement of the parties, this period may be further extended. Each Party shall comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of the other Party in any publications and presentations. For the avoidance of doubt, nothing in this Clause 10.7 shall require either Party to allow disclosure of its Confidential Information. | ||
11. | REGULATORY MATTERS | |
11.1 | Regulatory Approvals | |
Except with respect to Regulatory Approvals and Clinical Study Applications required to commence any Phase I Study undertaken by Emergent in accordance with the Development Plan, which approvals shall be obtained by Emergent, sanofi pasteur shall be responsible for the preparation and submission, at its own expense, but generally in consultation with Emergent, of all applications for any Regulatory Approvals required for the Exploitation of the Programme Antigens or any Product in any country in the Territory and Emergent shall, at sanofi pasteurs cost, provide such |
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assistance as sanofi pasteur may reasonably require in connection with such applications. Within a reasonable time prior to filing, Emergent or sanofi pasteur, as the case may be, shall provide to the SC for its consideration and comment (a) summaries of significant documents or reports relating to any Clinical Candidate or Product to be filed with any Regulatory Authority; and (b) copies or details of all significant communications and interactions with Regulatory Authorities relating to any Clinical Candidate or Product. For the avoidance of doubt, sanofi pasteur will not be required to share with Emergent any sanofi pasteur Confidential Information or Know How relating to sanofi pasteur Antigens or Third Party Antigens. | ||
11.2 | Adverse Event Reporting | |
The Parties shall develop, maintain and implement standard operating procedures for the investigation and reporting of Adverse Events concerning the Programme Antigens and any Product. The Parties shall immediately implement such agreed upon procedures and shall provide each other on a regular basis with any information which has become available to them and which is relevant to the safe use of the Programme Antigens or any Product or which is required by Applicable Law in all countries where any Programme Antigen or Product is marketed or is in a Clinical Study. Emergent shall be responsible for reporting Serious Adverse Events arising in connection with Emergent sponsored studies to the appropriate Regulatory Authorities in accordance with Applicable Law. sanofi pasteur shall be responsible for making all other such reports. Each Party shall forward to the other any information it receives relating to a Serious Adverse Event for a Product or Programme Antigen within twenty-four (24) hours of coming into possession or control of such information, by transmitting it in accordance with such procedures as the Parties may agree in writing from time to time. The Parties shall transmit to each other a copy of any report relating to a Serious Adverse Event for a Product or Programme Antigen made to any Regulatory Authority or ethics committee within two (2) Business Days following its submission to the Regulatory Authority by transmitting it in accordance with such procedures as the Parties may agree in writing from time to time. | ||
12. | WARRANTIES | |
12.1 | Mutual Warranties | |
Each Party hereby warrants to the other Party that: |
(a) | it is duly organised, validly existing and in good standing under the laws of the state or country, as applicable, in which it is organised; | ||
(b) | it has the requisite power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; | ||
(c) | it has taken all requisite action on its part to authorise the execution and delivery of this Agreement and the performance of its obligations hereunder; | ||
(d) | this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation enforceable against such Party in accordance with its terms except as enforcement may be limited by (i) |
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applicable bankruptcy, insolvency, reorganisation, moratorium, and other laws of general application affecting enforcement of creditors rights generally and (ii) by laws relating to the availability of specific performance, injunctive relief or other equitable remedies; | |||
(e) | all necessary consents, approvals and authorisations of all governmental authorities and other persons required to be obtained by it in connection with this Agreement have been obtained; and | ||
(f) | the execution and delivery of this Agreement and the performance of such Partys obligations hereunder (i) do not conflict with or violate any requirement of Applicable Law or any orders of governmental bodies; and (ii) do not conflict with, or constitute a default under, any contractual obligation of it. |
12.2 | Disclaimer | |
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND REGARDING TECHNOLOGY AND INFORMATION, MATERIALS, PRODUCTS OR INTELLECTUAL PROPERTY, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, ENFORCEABILITY OR VALIDITY. | ||
12.3 | Limitation on Liability | |
Except in circumstances of gross negligence or wilful misconduct by a Party or any of its Affiliates, directors, officers, employees or agents, neither Party shall be liable to the other with respect to the subject matter of this Agreement for special (including punitive and exemplary), indirect, incidental or consequential damages or lost profits, whether in contract, warranty, negligence, tort, strict liability or otherwise. This Clause 12.3 shall not limit either Partys liability pursuant to Clause 13. | ||
13. | INDEMNIFICATION | |
13.1 | Emergent Indemnity | |
Emergent shall indemnify, protect and hold harmless sanofi pasteur and its Affiliates, directors, officers, employees and agents (the sanofi pasteur Indemnitees ) against any and all losses, damages, fines, costs, expenses (including reasonable attorneys fees) and liabilities ( Liabilities ) incurred or imposed upon the sanofi pasteur Indemnitees, or any of them, in connection with any claims, suits, actions, demands or judgments of Third Parties ( Third Party Claim ) arising from or occurring as a result of: |
(a) | the breach by Emergent of any terms of this Agreement or the negligence of Emergent or any of the Emergent Indemnitees; and |
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(b) | Emergents activities under the Development Plan or any Annual Development Plan (including the use of any Programme Antigen or Product in any Phase I Study conducted by or for Emergent); except for those Liabilities for Third Party Claims in respect of which sanofi pasteur is responsible pursuant to Clause 9.6, which liabilities shall be borne by sanofi pasteur in accordance with that Clause, or for which sanofi pasteur has an obligation to indemnify Emergent and its Affiliates, directors, officers, employees and agents under Clause 13.2, as to which Liabilities each Party shall indemnify the other to the extent of their respective liability for such Liabilities. For the avoidance of doubt, Emergent shall have no liability to sanofi pasteur for any Third Party Claim alleging that any Emergent Activities infringe the intellectual property rights of any Third Party. |
13.2 | sanofi pasteur Indemnity | |
sanofi pasteur shall indemnify, protect and hold harmless Emergent and its Affiliates, directors, officers, employees and agents (the Emergent Indemnitees ) against any and all Liabilities incurred or imposed upon the Emergent Indemnitees, or any of them, in connection with any Third Party Claim arising from or occurring as a result of: |
(a) | the breach by sanofi pasteur of any terms of this Agreement or the negligence of sanofi pasteur or any of the sanofi pasteur Indemnitees; | ||
(b) | sanofi pasteurs activities under the Development Plan or any Annual Development Plan (including the use of any Programme Antigen or Product in any Clinical Study other than any Phase I Study conducted by or for Emergent); | ||
(c) | the Exploitation of any Programme Antigen or Product; and | ||
(d) | any allegation that the activities of either Party in accordance with this Agreement infringe the intellectual property rights of a Third Party. |
except for those Liabilities for Third Party Claims for which Emergent has an obligation to indemnify sanofi pasteur Indemnitees under Clause 13.1, as to which Liabilities each Party shall indemnify the other to the extent of their respective liability for such Liabilities. | ||
13.3 | Indemnification Procedure | |
In the event that either Party receives notice of a Third Party Claim such Party shall inform the other Party as soon as reasonably practicable. Subject to Clause 9, the Parties shall confer on how to respond to the Third Party Claim and how to handle the Third Party Claim in an efficient manner. In the event that a Party is seeking indemnification under this Clause 13 it shall permit the indemnifying Party (at the indemnifying Partys option) to assume direction and control of the defence of the Third Party Claim (including the right to settle the claim solely for monetary consideration), shall co-operate as requested (at the expense of the indemnifying Party) in the defence of the Third Party Claim, and shall not settle or compromise the Third Party Claim without the express written consent of the indemnifying Party, such |
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(a) | for any reason or no reason, upon not less than six (6) months prior written notice to Emergent, provided that such notice may not be served prior to the first anniversary of the Effective Date; and | ||
(b) | with immediate effect on a Change of Control of Emergent upon written notice to Emergent provided that such notice is served within thirty (30) days of the earlier of the date on which Emergent notifies sanofi pasteur of such Change of Control or the date on which sanofi pasteur becomes aware of such Change of Control. |
14.2.3 | Termination by Emergent . Emergent shall be entitled to terminate this Agreement: |
(a) | with immediate effect if sanofi pasteur challenges the validity or enforceability of any Emergent Patent Rights or Joint Patent Rights; | ||
(b) | if sanofi pasteur is in material breach of its obligation to use Commercially Reasonable Efforts pursuant to Clause 5.12 and does not remedy such breach within ninety (90) days of its receipt of written notice from Emergent requiring such breach to be remedied and without prejudice to the generality of the foregoing, sanofi pasteur shall be deemed to be in breach of such obligation if: |
(i) | there has been a material failure by sanofi pasteur to execute, resource or deliver the Development Plan; |
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(ii) | at any time prior to the grant of a Marketing Authorisation for a Product in a Major Market Country, sanofi pasteur does not have at least one Programme Antigen in active clinical Development provided that at least one Programme Antigen has met the Selection Criteria; | ||
(iii) | sanofi pasteur fails to select and progress into clinical Development a Programme Antigen that has met the Selection Criteria unless there is already a Programme Antigen in a Phase I Study or a later stage of active clinical Development or a Product is being marketed in a Major Market Country; | ||
(iv) | there is a material failure by sanofi pasteur to maintain, augment, exploit or defend the Emergent Technology or the Joint Technology in a commercially reasonable manner; | ||
(v) | sanofi pasteur fails to conduct any substantial Development activities during any twelve (12) month period; | ||
(vi) | there is a material failure by sanofi pasteur, other than for technical reasons, to use Commercially Reasonable Efforts to Develop the Product for all target vaccine populations agreed in the target product profile (e.g., new-borns, children to age two (2) and Adolescents); | ||
(vii) | sanofi pasteur or one of its Affiliates or any Sub-Licensee undertakes a Phase II study with a Competitive Product and sanofi pasteur is not actively continuing to Develop or Commercialise a Product; | ||
(viii) | sanofi pasteur or one of its Affiliates or any Sub-Licensee commences a Phase III Study with a Competitive Product, before sanofi pasteur commences a Phase III Study with a Product and sanofi pasteur is not actively continuing to Develop or Commercialise a Product; | ||
(ix) | there is a material failure by sanofi pasteur to provide Emergent with adequate and sufficiently detailed information to enable Emergent to assess whether sanofi pasteur is in breach of its diligence obligations pursuant to Clause 5.12, particularly after the Transition Date; or | ||
(x) | there is a registering/filing by sanofi pasteur or any Affiliate of sanofi pasteur or any Sub-Licensee for a Marketing Authorisation for a Competitive Product, if sanofi pasteur is not actively Developing or Commercialising a Product. |
(c) | if sanofi pasteur is in material breach of its obligation to use Commercially Reasonable Efforts pursuant to Clause 6.2 and does not remedy such breach within ninety (90) days of its receipt of written notice from Emergent requiring such breach to be remedied and without prejudice to the generality of the foregoing, sanofi pasteur shall be deemed to be in breach of such obligation if: |
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(i) | there is a material failure by sanofi pasteur to apply Commercially Reasonable Efforts to execute, resource and deliver the agreed Commercialisation Plan; | ||
(ii) | there is a material failure by sanofi pasteur to apply Commercially Reasonable Efforts as assessed by time, resource and performance criteria that would be applied by a commercial organisation to launch, commercialise, exploit and maximise the value of a paediatric vaccine product in a competitive global marketplace; | ||
(iii) | sanofi pasteur (or one of its Affiliates or a Sub-Licensee) launches, Commercialises or Exploits a Competitive Product, and sanofi pasteur is not actively Developing or Commercialising a Product; | ||
(iv) | there is a material failure by sanofi pasteur to provide Emergent with adequate and sufficiently detailed information to be able to assess whether sanofi pasteur is in breach of its diligence obligations pursuant to Clause 6.2; or | ||
(v) | there is a material failure by sanofi pasteur to provide sufficient information or access to an independent representative to enable assessment of royalties payable by sanofi pasteur to Third Parties as required pursuant to Clause 7.4.4, particularly in relation to the calculation of the Royalty Burden. |
(d) | if sanofi pasteur commits a material breach of its obligations under this Agreement (including any failure to pay when due an amount or amounts in aggregate exceeding Euros [**]) which (if capable of remedy) is not remedied within ninety (90) days of written notice requiring it to be remedied being received by sanofi pasteur. If there is a dispute relating to any payment to be made by sanofi pasteur, sanofi Pasteur shall pay the undisputed portion of such amount and the dispute relating to the disputed portion shall be resolved by the Senior Officers in accordance with Clause 25.2 or, failing that, in accordance with Clause 25.3. To the extent applicable, the decision of the Senior Officers or courts shall be applied to the future calculation of amounts properly due from sanofi pasteur in connection with this Agreement. | ||
(e) | with immediate effect upon written notice by Emergent, if (i) all Programme Antigens have been tested in preclinical Development and none have met the Selection Criteria, or (ii) all Programme Antigens that have met the Selection Criteria have been tested in a Phase I Study, and none of the Programme Antigens that have met the Selection Criteria have been found to meet the |
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Primary Inclusion Criteria, and in either case there has been no active Clinical Study involving a Programme Antigen for a period of twelve (12) months. |
14.3 | Consequences of Termination | |
14.3.1 | Termination by Emergent other than pursuant to Clause 14.2.3(e) . In the event that this Agreement is terminated by Emergent pursuant to Clause 14.2.1 or Clause 14.2.3(a) to (d) then: |
(a) | sanofi pasteur shall reimburse Emergent for all FTE Costs (including in respect of FTEs that would have been devoted to or supported Emergent Activities in the absence of such termination) and Emergent Expenses in each case incurred or suffered in, or relating to, the period ending on the later of (i) six (6) months from the date of the notice of termination; (ii) eighteen (18) months from the Effective Date and (iii) the date of termination, together with any non-cancellable Emergent Expenses committed to prior to the date of notice of termination whenever incurred; | ||
(b) | Emergent shall have a non-exclusive, fully paid-up, royalty free licence under the sanofi pasteur Programme Technology in the Field and, without prejudice to Emergents rights pursuant to Clause 14.3.7, sanofi pasteurs interest in the Joint Technology, to Exploit any Programme Antigens, Terminated Antigens, Repatriated Antigens or Product anywhere in the world with the right to grant sub-licences; provided that with respect to any Technology Controlled by sanofi pasteur pursuant to a sanofi pasteur In-Licence, the sub-licence granted by sanofi pasteur under such sanofi pasteur In-Licence shall be limited to such rights (if any) as sanofi pasteur is permitted to grant Emergent pursuant to the relevant sanofi pasteur In-Licence and provided further that Emergent shall be responsible for any payments under any such sanofi pasteur In-Licence attributable to the Exploitation of any Products by Emergent after the date of such termination. | ||
(c) | sanofi pasteur and Emergent shall, if requested by Emergent, discuss in good faith the terms, which terms shall be commercially reasonable, for the grant by sanofi pasteur to Emergent of a non-exclusive licence under the sanofi pasteur Independent Technology in the Field to Exploit Programme Antigens, Terminated Antigens, Repatriated Antigens and Products anywhere in the world; provided that in relation to any Technology Controlled by sanofi pasteur pursuant to a sanofi pasteur In-Licence, the Parties acknowledge that any sub-licence granted by sanofi pasteur under such sanofi pasteur In-Licence would be limited to such rights (if any) as sanofi is permitted to grant Emergent pursuant to the relevant sanofi pasteur In-Licence; and provided further that if requested by Emergent, sanofi pasteur shall use reasonable efforts to facilitate discussions between Emergent and any Third Party and shall not unreasonably restrict or impede the grant by any Third Party of rights to any Technology Controlled by such Third Party and necessary or reasonably useful for the Exploitation of Programme Antigens, Terminated Antigens, Repatriated Antigens or Products in the Field; |
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(d) | sanofi pasteur shall cease to use the Emergent Technology for any purpose and shall cease to Exploit any Programme Antigen or Product anywhere in the world; | ||
(e) | unless otherwise agreed pursuant to paragraph (c) above, Emergent shall cease to use the sanofi pasteur Independent Technology for any purpose; | ||
(f) | sanofi pasteur shall at Emergents request transfer to Emergent: |
(i) | all of its right, title and interest in all Regulatory Documentation and Regulatory Approvals then in its name applicable to any Programme Antigens or Product, and all material aspects of Confidential Information and correspondence Controlled by it as of the date of termination relating to such Regulatory Documentation and Regulatory Approvals; and | ||
(ii) | all relevant Know How, information, files or data relating to any Programme Antigens or Product, including copies of all reports and data generated or obtained by sanofi pasteur or its Affiliates pursuant to this Agreement that have not previously been provided to Emergent; |
(g) | sanofi pasteur shall, at its cost, take such actions as Emergent may reasonably require (including notifications to Regulatory Authorities) to ensure a smooth, orderly and cost-effective transfer of the conduct of Development and Commercialisation (to the extent then conducted by sanofi pasteur) of any Programme Antigens and Product (in the form of such Product as at the date of such termination) from sanofi pasteur to Emergent including in connection with: |
(i) | securing supplies of such Product, including, if appropriate, the assignment of relevant agreements for the manufacture of such Product to Emergent (unless if and to the extent any such agreement precludes sanofi pasteur, having taken, at Emergents request and expense, such action as Emergent may reasonably require, from making such assignment), the transfer by sanofi pasteur to Emergent or its designee, at Emergents request, of all stocks of Product or constituent materials available to sanofi pasteur at the time of termination at a transfer price equal to sanofi pasteurs cost of goods for the supply of such Product or constituent plus [**] percent ([**]%) and the transfer to Emergent of all information in its possession with respect to the manufacture of such Product or any constituent; and | ||
(ii) | the transfer to Emergent of control of all Clinical Studies of Clinical Candidates being conducted as of the effective date of termination. |
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14.3.2 | Termination at Will by sanofi pasteur . In the event that this Agreement is terminated by sanofi pasteur pursuant to Clause 14.2.2(a) then: |
(a) | Clause 14.3.1 other than sub-clause 14.3.1(b) shall apply; |
(b) | without prejudice to Emergents rights pursuant to Clause 14.3.7, Emergent shall have a non-exclusive, fully paid-up, royalty free licence under sanofi pasteurs interest in the Joint Technology to Exploit any Programme Antigens, Terminated Antigens, Repatriated Antigens or Product anywhere in the world with the right to grant sub-licences for the Exploitation of such Programme Antigens, Terminated Antigens and Repatriated Antigens; | ||
(c) | sanofi pasteur and Emergent shall, if requested by Emergent, discuss in good faith the terms, which terms shall be commercially reasonable, for the grant by sanofi pasteur to Emergent of a non-exclusive licence under the sanofi pasteur Programme Technology in the Field to Exploit Programme Antigens, Terminated Antigens, Repatriated Antigens and Products anywhere in the world; provided that in relation to any Technology Controlled by sanofi pasteur pursuant to a sanofi pasteur In-Licence, the Parties acknowledge that any sub-licence granted by sanofi pasteur under such sanofi pasteur In-Licence would be limited to such rights (if any) as sanofi is permitted to grant Emergent pursuant to the relevant sanofi pasteur In-Licence; and | ||
(d) | sanofi pasteur and Emergent shall, if requested by sanofi pasteur, discuss in good faith the terms, which terms shall be commercially reasonable, for the grant by Emergent to sanofi pasteur of a non-exclusive licence under the Emergent Programme Technology in the Field. |
14.3.3 | Termination by Emergent pursuant to Clause 14.2.3(e) . In the event that this Agreement is terminated by Emergent pursuant to Clause 14.2.3(e) then: |
14.3.4 | Termination of Collaboration for a Change of Control of Emergent or Emergents Insolvency . In the event that sanofi pasteur terminates this Agreement pursuant to Clause 14.2.1 (an insolvency event) or Clause 14.2.2(b) (a Change of Control) such termination shall be treated as a termination at will pursuant to Clause 14.2.2(a), and Clause 14.3.2 shall apply. If sanofi pasteur elects not to terminate this Agreement in such circumstances it may, by serving notice on Emergent within thirty (30) days of the date on which sanofi pasteurs right to terminate this Agreement arose under Clause 14.2.1 or within the period specified in Clause 14.2.2(b) (as the case may be), elect to continue to Exploit Programme Antigens and Products on the terms of this Agreement subject to the following modifications: |
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(a) | the JPT and the SC shall be disbanded and cease to have any responsibilities and, subject to Clause 3.5.2, which shall continue to apply to any decisions made by sanofi pasteur, sanofi pasteur shall be entitled to make all strategic decisions relating to the Development of Programme Antigens and Products, provided that in reaching any such decision sanofi pasteur shall act in good faith and in the best interests of the Development and Commercialisation of the Product; | ||
(b) | Emergent shall cease to have any obligations under the Development Plan or Annual Development Plan; provided that if the Change of Control or insolvency occurs prior to the Transition Date, sanofi pasteur shall continue to reimburse Emergent for all FTE Costs and Emergent Expenses, in each case incurred or suffered in, or relating to, the period ending six (6) months from the date of such notice together with any non-cancellable Emergent Expenses committed to prior to such date, provided that during such period Emergent shall follow sanofi pasteurs reasonable instructions for the smooth, orderly and cost-effective transfer of Emergent Activities to sanofi pasteur; | ||
(c) | sanofi pasteur shall prepare each Development Plan, Annual Development Plan and Commercialisation Plan and submit each such plan to Emergent. If and to the extent sanofi pasteur is not prepared to disclose information contained in any such plan to Emergent such information shall be disclosed to an independent expert appointed pursuant to paragraph (e) below; | ||
(d) | sanofi pasteur shall prepare reports of its Development Activities in accordance with Clause 5.10 and submit the same to Emergent. If and to the extent the Parties are unable to agree the form of the report or sanofi pasteur is not prepared to disclose information contained in the report to Emergent such information shall be disclosed to an independent expert appointed pursuant to paragraph (e) below; | ||
(e) | in the event that sanofi pasteur refuses to disclose any plans or reports to Emergent pursuant to paragraphs (c) or (d) above, or at Emergents request at any other time but not more frequently than once in any Year, the Parties shall upon Emergents request appoint an independent expert with suitable experience reasonably acceptable to both Parties to review and verify the activities being conducted by sanofi pasteur in connection with the Development and Commercialisation of any Programme Antigen or Product. If the Parties are unable to agree on the identity of the independent expert within ten (10) days of Emergent notifying sanofi pasteur that it desires the appointment of such expert, the independent expert shall be appointed by Emergent and approved by sanofi pasteur, which approval shall not be unreasonably withheld, conditioned or delayed. Upon such appointment, sanofi pasteur shall promptly furnish to the expert (subject to such obligations of confidentiality and non-use as may be reasonably required by sanofi pasteur) all information necessary for the expert to determine whether sanofi pasteur is using Commercially Reasonable Efforts to Develop and Commercialise Products in accordance with this Agreement but for the avoidance of doubt such determination shall not be binding on Emergent. The expert shall be required by the Parties to use all reasonable efforts to render his |
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decision within thirty (30) days following his receipt of all such information. The Parties shall share equally the fees and expenses of such expert; | |||
(f) | for the purposes of Clause 5.15, sanofi pasteur shall assume the responsibilities of the SC and shall consider whether Programme Antigens should be designated Terminated Antigens; | ||
(g) | all other provisions of this Agreement shall continue in full force and effect without modification. |
For the avoidance of doubt, if sanofi pasteur does not elect either to terminate this Agreement or terminate the collaborative aspects of this Agreement by serving notice on Emergent in accordance with Clause 14.2.1, Clause 14.2.2(b) or this Clause 14.3.4 (as the case may be) within thirty (30) days of the date on which sanofi pasteurs right to terminate this Agreement arose under Clause 14.2.1 or within the period specified in Clause 14.2.2(b) (as the case may be), this Agreement shall continue in full force and effect without any modification. | ||
14.3.5 | Termination of Emergent Activities . If Emergent commits a material breach of its obligations under this Agreement with respect to the performance by Emergent of the Emergent Activities which (if capable of remedy) is not remedied within ninety (90) days of written notice requiring it to be remedied being received by Emergent, sanofi pasteur may on written notice terminate all Emergent Activities and on such termination Emergent shall cease to have any right or obligation to undertake activities under the Development Plan or Annual Development Plan and the Joint Project Team shall be disbanded. | |
14.3.6 | Termination of Collaboration for Emergents Breach . In the event that Emergent commits a material breach of its obligations under (i) Clauses 2.4 or 9.2.5; (ii) Clause 10 and the prohibited disclosure constitutes a statutory bar to obtaining patent protection in a Major Market Country that would otherwise have been available for an invention within the Emergent Technology or Joint Technology; (iii) Clause 10 and the prohibited disclosure results in the loss of trade secret status for any trade secret previously identified as such by sanofi pasteur in writing to Emergent provided that Emergent has agreed that the information so identified is a trade secret (provided further that such agreement shall not be unreasonably withheld, conditioned or delayed), and the prohibited disclosure is a direct result of Emergents gross negligence or wilful misconduct and such prohibited disclosure has a material and irreparable adverse effect on the value or commercial potential of the Emergent Technology or Joint Technology (taken as a whole) in at least one Major Market Country; or (iv) this Agreement with respect to the performance of the Emergent Activities and such material breach is a direct result of Emergents gross negligence or wilful misconduct and has a material and irreparable adverse effect on the value or commercial potential of the Emergent Technology or Joint Technology (taken as a whole) in at least one Major Market Country, in each case where such material breach (if capable of remedy) is not remedied within ninety (90) days of written notice requiring it to be remedied being received by Emergent, sanofi pasteur may serve further notice on Emergent terminating the collaborative aspects of this Agreement and on receipt of such notice by Emergent Clause 14.3.4 (a) and (c) to (g) shall apply except that: |
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(a) | sanofi pasteur shall cease to have any obligation to pay any milestone payment pursuant to Clause 7.2.1 if the relevant milestone event occurred after receipt of such notice; | ||
(b) | sanofi pasteur shall not have any obligation to reimburse Emergent for any FTE costs or Emergent Expenses relating to the period after such notice unless if and to the extent that sanofi pasteur requires Emergent to provide assistance with the transfer of any Emergent Activities to sanofi pasteur; and | ||
(c) | Emergent shall cease to have any obligations under the Development Plan or Annual Development Plan. |
14.3.7 | Joint Technology . In relation to the Joint Technology after termination: |
(a) | Ownership and Rights . As between the Parties, each Party shall own an undivided one-half interest in and to the Joint Technology with full ownership rights in and to any field and each Party shall have the right, subject to the rights and licences granted under, and the other provisions of, this Agreement, to freely Exploit, transfer, license or encumber its rights in any such jointly owned subject matter without the consent of, or payment or accounting to, the other Party, and each Party waives any right it may have under Applicable Law to require such payment, accounting or consent. | ||
(b) | Filing, Prosecution and Maintenance . The Parties shall agree which Party (in this Clause 14.3.7, the Controlling Party ) shall be responsible, using counsel reasonably acceptable to both Parties, for the preparation, filing, prosecution and maintenance of the Joint Patent Rights as agreed by the Parties. All out-of-pocket costs incurred by the Parties in connection with the preparation, filing, prosecution and maintenance of Joint Patent Rights shall be shared equally between the Parties. To the extent practicable, the Controlling Party shall provide the other Party and its counsel with an opportunity to consult with the Controlling Party and its counsel regarding the filing and contents of any application, amendment, registration, submission, response or correspondence with any patent authorities with respect to, and the Controlling Party shall consider in good faith the reasonable requests of the other Party regarding the filing and prosecution of such Patent Rights and shall not, without the prior written consent of the other Party (which approval shall not be unreasonably withheld, conditioned or delayed), cease the prosecution or maintenance of, or modify the claims of, or elect not to file a patent application in respect of any Joint Patent Rights. | ||
(c) | Election not to File, Prosecute or Maintain . If one Party does not wish to bear the expenses in connection with the preparation, filing, prosecution or maintenance of any Joint Patent Rights in any country it shall notify the other Party who shall have the right to prepare, file, prosecute and maintain such Joint Patent Rights at its own expense, through counsel of its choosing, without the consent of such first Party, whereupon the first Party shall, and shall cause its Affiliates to, (i) reasonably cooperate with the other Party in this regard, and (ii) promptly release or assign to the other Party, without consideration, all right, title and interest in and to such Joint Patent Rights in such country. If the other Party fails to notify the first Party within ninety (90) days |
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that it wishes to assume such responsibility at its own cost, and the first Party is the Controlling Party, the Controlling Party shall be free to allow such Joint Patent Rights to lapse. |
14.3.8 | Confidential Information and Materials . On expiration or termination of this Agreement for any reason, (i) each Party shall promptly return all Confidential Information of the other Party that is not subject to a licence grant hereunder that survives such expiration or termination; provided that each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations under this Agreement and (ii) sanofi pasteur shall either return or, at Emergents request, destroy all Emergent Materials provided that sanofi pasteur may retain Materials that are subject to a continuing licence grant hereunder. | |
14.3.9 | Other Consequences . The expiration or termination of this Agreement for any reason shall be without prejudice to: |
(a) | the obligation of either Party to pay to the other Party any amount due to the other Party with respect to the period prior to the effective date of such expiration or termination, by way of royalty or otherwise, under this Agreement; | ||
(b) | any right of, or remedy available to, either Party against the other Party in respect of anything done or omitted under this Agreement prior to such expiration or termination; and | ||
(c) | those rights, and shall not release either Party from those of its obligations, which expressly survive termination in accordance with this Agreement and Clauses 8.3.2, 9.1.4, 9.1.6, 10, 11.2, 12.3, 13, 14.3, 16, 17, 18, 21, 22, 23, 25, and 28 and all payment, reporting and audit terms to the extent applicable to activities occurring before or surviving termination and any other provisions which are expressed to survive expiration or termination or which are required to give effect to such expiration or termination shall continue in full force and effect. |
14.4 | No Further Grant | |
Except as specified in Clauses 14.1 and 14.3 neither Party shall be under any obligation to grant the other Party any licence under any Emergent Technology or sanofi pasteur Technology with respect to the period after the expiration or termination of this Agreement. | ||
15. | FORCE MAJEURE | |
15.1 | Force Majeure | |
A Party shall not be liable for a failure to perform any of its obligations under this Agreement during the period and to the extent that that Party is prevented or hindered from complying with them by any cause beyond its reasonable control including (insofar as beyond such control but without prejudice to the generality of the foregoing expression) strikes, lock-outs, labour disputes, act of God, war, riot, civil |
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commotion, terrorism, epidemic disease, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm, earthquake (each an event of Force Majeure). The affected Party shall give notice to the other Party of the event of Force Majeure and its effect on its ability to perform its obligations. If the notice is not given by the affected Party within a reasonable period after that Party knew or ought to have known of the event of Force Majeure, it shall remain liable to the other Party for the consequences of its failure to perform. | ||
15.2 | Obligation to Consult | |
The exemption provided by Clause 15.2 shall be granted to the relevant Party for as long as the event of Force Majeure persists; provided that if it shall persist for a continuous period of more than six (6) months the Party not affected by the event of Force Majeure may terminate this agreement on thirty (30) days notice. | ||
16. | PUBLICITY | |
16.1 | Press Announcement . | |
The Parties shall release the press announcement set out in Schedule 6 on the date of this Agreement or on such later date as may be agreed by the Parties. | ||
16.2 | No Publicity Without Consent | |
Subject to Clauses 16.1 and 16.3 neither Party shall make any public announcement or statement or issue any press release or other publicity materials or make any other disclosure with respect to the existence of this Agreement, its terms, conditions or subject matter, or the status or content or conduct of the Development Programme without the prior written consent of the other Party except if and to the extent (i) required by Applicable Law, the rules or regulations of a relevant stock exchange or similar governing body (including the U.S. Securities and Exchange Commission) or an order of any government agency, department or court, provided that in each such case the disclosing Party shall to the extent permitted promptly notify the other of such disclosure; or (ii) the proposed public announcement does not contain information beyond that included in an earlier press release issued in accordance with this Clause 16. | ||
16.3 | Permitted Disclosure | |
Either Party may disclose the terms or conditions of this Agreement and, subject to Clause 10, information relating to the status, content or conduct of the Development Programme: |
(a) | on a need to know basis to its, and its Affiliates, legal and financial advisors to the extent such disclosure is reasonably necessary in connection with such Partys activities as expressly permitted by this Agreement or for the conduct of its business; | ||
(b) | to a Third Party in connection with: |
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(i) | an equity investment or other form of financing in such Party, or one of its Affiliates, by such Third Party; | ||
(ii) | a merger, consolidation or similar transaction entered into by such Party, or one of its Affiliates; or |
(iii) | the sale of all or substantially all of the assets of such Party, or one of its Affiliates; |
(c) | as may be required in connection with an offer of shares or other securities by that Party or one of its Affiliates to the public; | ||
(d) | on a need to know basis, to a prospective assignee pursuant to Clause 19.1 and such Third Partys employees, advisors, representatives, Affiliates, partners, members, shareholders and financing sources; or | ||
(e) | to any government agency or authority, at its request or as may be required by Applicable Law, regulation, rule or order. |
17. | NOTICES | |
17.1 | Notices | |
Any notice in connection with this Agreement (a Notice ) will be in writing, in the English language, signed by or on behalf of the Party giving it and will be delivered by hand (including by internationally recognised courier), or prepaid airmail, facsimile transmission, but not e-mail, either to the recipient at the address or facsimile number set out for that Party in Clause 17.3 or such other address or facsimile number within the same country as set out below for that Party as the recipient has previously notified to the sender in accordance with this clause. | ||
17.2 | Deemed service of Notices | |
A Notice shall be deemed to have been duly served: |
(a) | if delivered by hand, at the time of delivery; | ||
(b) | if sent by prepaid airmail at 10.00 a.m. (local time at the place of destination) on the fifth Business Day after the date on which it was mailed; and | ||
(c) | if sent by facsimile, at the time of transmission; provided that a confirming copy is sent by first class post or prepaid airmail if the sender and recipient are in different countries within twenty-four (24) hours after transmission and that no notification informing the sender that the facsimile has not been delivered has been received by the sender; |
17.3 | Addresses for Notices |
69
The addresses and facsimile numbers for the parties are as follows: | ||
If to Emergent: |
17.4 | Notices Served In Court Proceedings | |
For the avoidance of doubt, where proceedings have been commenced in any court of competent jurisdiction, any documents issued in the course of those proceedings will be served in accordance with the procedural rules governing the service of documents in those proceedings. | ||
17.5 | Other Communications |
70
(a) | on written notice to sanofi pasteur but without sanofi pasteurs consent, assign to any Third Party any or all of Emergents rights under Clause 7.2 and Clause 7.3, and in connection with such an assignment, any or all of its rights under Clause 7.4, Clause 7.6 through 7.9 and/or Clause 7.11; and | ||
(b) | assign, and grant a security interest in, without the consent of sanofi pasteur, any or all of its rights under this Agreement to any Third Party providing financing to Emergent, and its successors and assigns, or any agent or trustee acting on its behalf. sanofi pasteur hereby acknowledges that any such assignment and granting of a security interest are made only for the purpose of securing Emergents obligations to such Third Party under the applicable financing documents, and shall not subject such Third Party, and its respective successors and assigns, or any agent or trustee acting on its behalf, to, or transfer or in any way affect or modify, any obligation or liability that Emergent may have to sanofi pasteur hereunder. Further, notwithstanding Clause 20, any such Third Party shall be considered a third-party beneficiary of this Agreement with a right of enforcement as if it were a Party hereto. |
19.2 | Other Assignments |
71
Subject to the foregoing provisions of Clause 19.1 neither Party shall assign, sub-contract, sub-license, charge or part with or otherwise dispose of this Agreement or the benefit thereof or any right or obligation hereunder to a Third Party without the express prior written consent of the other Party such consent not to be unreasonably withheld, conditioned, or delayed. | ||
19.3 | Performance by Affiliates | |
Each Party may perform any and all of its obligations and exercise any and all of its rights under this Agreement through any Affiliate; provided that such Party shall remain responsible to the other Party for the compliance by any such Affiliate of its performance of this Agreement. | ||
20. | THIRD PARTY RIGHTS | |
This Agreement does not create any right enforceable by any person who is not a Party except that a person who is the permitted successor to or assignee of the rights of a Party shall, subject to and upon any succession or assignment permitted by this Agreement, be deemed to be a party to this Agreement and the rights of such successor or assignee shall be regulated by the terms of this Agreement. | ||
21. | WAIVER | |
The failure on the part of either Party to exercise or enforce any right conferred upon it hereunder shall not be deemed to be a waiver of any such right or operate to bar the enforcement thereof at any time or times thereafter. | ||
22. | SEVERABILITY | |
22.1 | Severability | |
If the whole or any part of this Agreement is or becomes or is declared illegal, invalid or unenforceable in any jurisdiction for any reason (including both by reason of the provisions of any legislation and also by reason of any decision of any court or Regulatory Authority which either has jurisdiction over this Agreement or has jurisdiction over any of the Parties): |
(a) | in the case of the illegality, invalidity or unenforceability of the whole of this Agreement, it shall terminate in relation to the jurisdiction in question; or | ||
(b) | in the case of the illegality, invalidity or unenforceability of part of this Agreement, that part shall be severed from this Agreement in the jurisdiction in question and that illegality, invalidity or unenforceability shall not in any way whatsoever prejudice or affect the remaining parts of this Agreement which shall continue in full force and effect. |
22.2 | Good Faith Negotiation | |
If any such circumstances arise and the commercial relationship between the Parties contemplated hereby is as a result significantly altered the Parties shall negotiate in good faith an appropriate amendment to this Agreement. |
72
23. | ENTIRE AGREEMENT | |
23.1 | Entire Agreement | |
This Agreement (including the Schedules) constitute the entire agreement between the parties relating to their subject matter, and supersede all prior written or oral agreements, representations or understandings between the parties relating to that subject matter. | ||
23.2 | No Reliance on Other Provisions | |
Each Party confirms that, in agreeing to enter into this Agreement, it has not relied on any representation, warranty, collateral contract or other assurance except those set out in this Agreement and to the extent any previous representation, warranty, collateral contract or assurance was made to a Party, such Party waives all rights and remedies with respect thereto. | ||
23.3 | Implied Terms | |
ALL CONDITIONS, WARRANTIES AND OTHER TERMS IMPLIED BY STATUTE OR COMMON LAW ARE HEREBY EXCLUDED TO THE FULLEST EXTENT PERMITTED BY LAW. | ||
23.4 | No Exclusion for Fraud | |
Nothing in this Agreement will operate to limit or exclude a Partys liability for fraud. | ||
24. | AMENDMENTS | |
No amendment or variation of this Agreement shall be valid and effective unless in writing and signed by or on behalf of each Party. | ||
25. | GOVERNING LAW AND JURISDICTION | |
25.1 | Governing Law | |
This Agreement shall be governed and construed in accordance with the laws of the State of Delaware, without giving effect to the conflicts of laws principles thereof. | ||
25.2 | Dispute Resolution | |
Except as provided in Clause 3.5.1, or in relation to any matter which is to be finally determined by an independent expert in accordance with this Agreement, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection with this Agreement, then either Party shall have the right to refer such dispute to the Senior Officers who shall seek to resolve such dispute. Any final decision mutually agreed to by the Senior Officers shall be in writing and shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of an issue within twenty (20) days after such issue was first referred to them (or such longer period as they may agree), Clause 25.3 shall apply. |
73
25.3 | Jurisdiction | |
Subject to Clause 25.2, all disputes between the Parties arising in connection with this Agreement shall be referred to and finally resolved by the courts located in the State of Delaware and the Parties irrevocably and unconditionally submit to the exclusive jurisdiction of such courts for any action, suit or proceeding arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial. The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding arising out of or relating to this Agreement in such courts, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. | ||
25.4 | Process Agents | |
Without prejudice to any other mode of service allowed under any relevant law: |
(a) | Emergent irrevocably appoints Emergent Biosolutions, Inc as its agent for service of process in relation to any proceedings before the courts located in the State of Delaware in connection with this Agreement and further agrees that service of any process, summons, notice or document by U.S. registered mail to the General Counsel of Emergent Biosolutions, Inc at the address for that company set out in Clause 17.3 (or such other address in the United States as may have been notified to sanofi pasteur in accordance with Clause 17) shall be effective service of process for any action, suit or proceeding brought against it under this Agreement; and | ||
(b) | sanofi pasteur irrevocably appoints Connaught Technology Corp. as its agent for service of process in relation to any proceedings before the courts located in the State of Delaware in connection with this Agreement and further agrees that service of any process, summons, notice or document by U.S. registered mail to Kathleen Winter, President of Connaught Technology Corp. (or any successor President) at 3711 Kennett Pike, Suite 200 Greenville, Delaware 19807; (or such other address in the United States as may have been notified to Emergent in accordance with Clause 17) shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court. |
25.5 | Interim Relief | |
Nothing in this Agreement shall prohibit a Party from seeking interim relief in any court of competent jurisdiction. | ||
26. | SUCCESSORS AND ASSIGNS | |
This Agreement shall be binding upon and enure for the benefit of both Parties and their successors and permitted assigns, as the case may be. |
74
27. | COUNTERPARTS | |
This Agreement may be executed in any number of counterparts and all the counterparts when taken together will constitute one agreement. Each Party may enter into this Agreement by executing a counterpart. | ||
28. | LANGUAGE | |
This Agreement is drawn up and executed in the English language. If there is any conflict between this Agreement and any translation of this Agreement, the English language version of this Agreement will prevail. |
EMERGENT EUROPE LIMITED | SANOFI PASTEUR, S.A. | ||||||||
|
|||||||||
By:
|
/s/ S.N. Chatfield | By: | /s/ Dominique Carouge | ||||||
|
|||||||||
|
|||||||||
Name: Dr. Steve Chatfield PhD | Name: Dominique Carouge | ||||||||
Title: President | Title: Chief Financial Officer | ||||||||
|
|||||||||
|
By: | /s/ Michel DeWilde | |||||||
|
|||||||||
Name: Michel DeWilde | |||||||||
Title: Sr. Vice President of Research & Development |
75
Schedule 1 Appendix 1 | 1 |
Schedule 1 Appendix 1 | 2 |
| [**] |
Schedule 1 Appendix 1 | 3 |
Schedule 1 Appendix 1 | 4 |
Schedule 1 Appendix 1 | 5 |
Schedule 1 Appendix 1 | 6 |
Schedule 1 Appendix 1 | 7 |
Schedule 1 Appendix 1 | 8 |
Function | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | M10 | M11 | M12 | ||||||||||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Purification
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Purification
management
|
||||||||||||||||||||||||
Pre-clinical
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Pre-clinical
management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Total (FTE)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
Function | M13 | M14 | M15 | M16 | M17 | M18 | M19 | M20 | M21 | M22 | M23 | M24 | ||||||||||||
Mol Biol
|
||||||||||||||||||||||||
Purification
|
[**] | |||||||||||||||||||||||
Purification
management
|
||||||||||||||||||||||||
Pre-clinical
|
[**] | [**] | [**] | [**] | ||||||||||||||||||||
Pre-clinical
management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||
Total (FTE)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] |
Schedule 1 Appendix 1 | 9 |
No. | Unit | Total | ||||
Equipment | Req. | Cost (£) | Cost (£) | |||
[**]
|
[**] | [**] | [**] | |||
[**]
|
[**] | [**] | [**] | |||
[**]
|
[**] | [**] | [**] |
Schedule 1 Appendix 1 | 10 |
Schedule 1 Appendix 2 | 1 |
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] | ||
|
| [**] |
Schedule 1 Appendix 2 | 2 |
i) | [**] | ||
ii) | [**] | ||
iii) | [**] |
Schedule 1 Appendix 2 | 3 |
Schedule 1 Appendix 2 | 4 |
Schedule 1 Appendix 2 | 5 |
Schedule 1 Appendix 2 | 6 |
Schedule 1 Appendix 2 | 7 |
Schedule 1 Appendix 2 | 8 |
Schedule 1 Appendix 2 | 9 |
Schedule 1 Appendix 2 | 10 |
| Clinical Candidate 2 at [**] escalating dose levels ([**] groups). These groups to be dosed in escalating [**] before [**]. | ||
| [**] at escalating dose levels (same quantity of each protein). |
Schedule 1 Appendix 2 | 11 |
Schedule 1 Appendix 2 | 12 |
Function | M1-Y1 | M2-Y1 | M3-Y1 | M4-Y1 | M5-Y1 | M6-Y1 | M7-Y1 | M8-Y1 | M9-Y1 | M10-Y1 | M11-Y1 | M12-Y1 | ||||||||||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Process Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Analytical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Pre-clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Regulatory
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
QA
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Total (FTEs)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
Schedule 1 Appendix 2 | 13 |
Function | M1-Y2 | M2-Y2 | M3-Y2 | M4-Y2 | M5-Y2 | M6-Y2 | M7-Y2 | M8-Y2 | M9-Y2 | M10-Y2 | M11-Y2 | M12-Y2 | ||||||||||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Process Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Analytical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Pre-clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Regulatory
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
QA
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Total (FTEs)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
Function | M1-Y3 | M2-Y3 | M3-Y3 | M4-Y3 | M5-Y3 | M6-Y3 | M7-Y3 | M8-Y3 | M9-Y3 | M10-Y3 | M11-Y3 | M12-Y3 | ||||||||||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Process Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Analytical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Pre-clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Regulatory
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
QA
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Clinical Dev
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||
Total (FTEs)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
Schedule 1 Appendix 2 | 14 |
Function | M1-Y4 | M2-Y4 | M3-Y4 | M4-Y4 | M5-Y4 | |||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | |||||
Process Dev
|
[**] | [**] | [**] | [**] | [**] | |||||
Analytical Dev
|
[**] | [**] | [**] | [**] | [**] | |||||
Pre-clinical Dev
|
[**] | [**] | [**] | [**] | [**] | |||||
Regulatory
|
[**] | [**] | [**] | [**] | [**] | |||||
QA
|
[**] | [**] | [**] | [**] | [**] | |||||
Clinical Dev
|
[**] | [**] | [**] | [**] | [**] | |||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | |||||
Management
|
[**] | [**] | [**] | [**] | [**] | |||||
Total (FTEs)
|
[**] | [**] | [**] | [**] | [**] |
Schedule 1 Appendix 2 | 15 |
Function | Process / Task | Cost (£) | ||||
Molecular Biology
|
[**] | [**] | ||||
Total Molecular Biology
|
[**] | |||||
|
||||||
Product development
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total product Development
|
[**] | |||||
|
||||||
Analytical
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total Analytical
|
[**] | |||||
|
||||||
Pre-clinical
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total Pre-Clinical
|
[**] | |||||
|
||||||
Clinical testing
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total clinical Testing
|
[**] | |||||
|
||||||
Clinical
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total Clinical
|
[**] |
Schedule 1 Appendix 2 | 16 |
Function | Process / Task | Cost (£) | ||||
Quality
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
|
[**] | [**] | ||||
Total Quality
|
[**] | |||||
|
||||||
Regulatory
|
[**] | [**] | ||||
Total Regulatory
|
[**] | |||||
|
||||||
Total Other Costs
|
[**] | [**] | ||||
|
||||||
Total Direct Project Cost
|
[**] |
Schedule 1 Appendix 2 | 17 |
Schedule 1 Appendix 3 | 1 |
Schedule 1 Appendix 3 | 2 |
Schedule 1 Appendix 3 | 3 |
Function | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | M10 | M11 | M12 | ||||||||||||||||||||||||||||||||||||
Mol Biol
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||||||||||||||||||||||||||
Purification
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||||||||||||||||||||||||||
Purification
management
|
||||||||||||||||||||||||||||||||||||||||||||||||
Pre-clinical
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||||||||||||||||||||||||||
Pre-clinical
management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||||||||||||||||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | ||||||||||||||||||||||||||||||||||||
Total (FTE)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
Function | M13 | M14 | M15 | M16 | M17 | M18 | M19 | M20 | M21 | |||||||||||||||||||||||||||
Mol Biol
|
||||||||||||||||||||||||||||||||||||
Purification
|
[**] | |||||||||||||||||||||||||||||||||||
Purification
management
|
||||||||||||||||||||||||||||||||||||
Pre-clinical
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||||||||||||||
Pre-clinical
management
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||||||||||||||
Project Leader
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||||||||||||||
Total (FTE)
|
[**] | [**] | [**] | [**] | [**] | [**] | [**] |
Schedule 2 | 1 |
Unit | ||||||||||||
Equipment | No. Req. | Cost (£) | Total Cost (£) | |||||||||
[**]
|
[**] | [**] | [**] | |||||||||
[**]
|
[**] | [**] | [**] | |||||||||
[**]
|
[**] | [**] | [**] |
Jan | Feb | Mar | ||||||||||
Function | 06 | 06 | 06 | |||||||||
Mol Biol
|
[**] | [**] | [**] | |||||||||
Purification
|
[**] | [**] | [**] |
Schedule 2 | 2 |
Jan | Feb | Mar | ||||||||||
Function | 06 | 06 | 06 | |||||||||
Purification management
|
||||||||||||
Pre-clinical
|
[**] | [**] | [**] | |||||||||
Pre-clinical management
|
[**] | [**] | [**] | |||||||||
Project leader
|
[**] | [**] | [**] | |||||||||
Total (FTE)
|
[**] | [**] | [**] |
Total | ||||||||
Equipment | No. | Cost (£) | ||||||
[**]
|
[**] | [**] | ||||||
[**]
|
[**] | [**] | ||||||
[**]
|
[**] | [**] | ||||||
Total Costs to date (£)
|
[**] |
Candidates | Emergent | |||||||||||
Number | NMB No. | Designation | Function | |||||||||
[**]
|
[**] | [**] | [**] |
Schedule 2 | 3 |
Document Type
Territory
Document Number (Application and Publication)
PCT/GB01/02003
WO01/85772
EP
01925742.7
US
10/275026
AU
52422/01
776508
AU/div
2004203417
CA
2408738
CN
01809191.1
CN/div
Not Yet Known
CZ
PV 2002-3642
HK
03108186.4
HU
P0302481
JP
2001-582371
KR
2002-7014876
NO
2002-5329
NZ
522277
NZ
532297
NZ
539912
RU
2002132891
RU/div
2005101623
SG
2002068393
Schedule 5
1
Document Type | Territory | Document Number (Application and Publication) | ||
PCT
|
PCT/GB01/03759 | |||
|
WO02/016612 | |||
|
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National Filings
|
EP | 01960908.0 | ||
|
US | 10/362327 | ||
|
AU | 2001/282299 | ||
|
CA | 2420261 | ||
|
CN | 01815395.X | ||
|
CZ | PV 2003495 | ||
|
HK | 05102145.5 | ||
|
HU | P0300813 | ||
|
IN | 00223/DELNP/200 | ||
|
JP | 2002-522283 | ||
|
KR | 2003-7002608 | ||
|
NO | 2003 0821 | ||
|
NZ | 524277 | ||
|
NZ/div | 538864 | ||
|
RU | 2003107837 | ||
|
SG | 2003029345 |
Schedule 5 | 2 |
Schedule 6 | 1 |
Schedule 7 | 1 |
Schedule 8 | 1 |
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Schedule 9 | 1 |
Schedule 10 | 1 |
Schedule 10 | 2 |
Schedule 10 | 3 |