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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2002
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission file number 0-26758
ALKERMES CLINICAL PARTNERS, L.P.
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(Exact name of registrant as specified in its charter)
DELAWARE 043-145043
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(State or other jurisdiction (I.R.S. Employer
of organization) Identification No.)
88 Sidney Street, Cambridge, MA 02139-4136
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (617) 494-0171
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Class A Limited Partnership Interests are not traded on any exchange.
Securities registered pursuant to Section 12(g) of the Act:
Class A Limited Partnership Interest
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(Title of Class)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes X No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K (ss.229.405 of this chapter) is not contained herein, and
will not be contained, to the best of Registrant's knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. [X]
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Act). Yes No X
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State the aggregate market value of voting stock held by non-affiliates of
the Registrant: There is no voting equity security of the Registrant and there
is no market, public or private, for the equity securities of the Registrant.
NO DOCUMENTS ARE INCORPORATED BY REFERENCE IN THIS REPORT ON FORM 10-K.
ITEM 1. BUSINESS
The following Business section contains forward-looking statements
which involve risks and uncertainties. The Partnership's actual results could
differ materially from those anticipated in these forward-looking statements as
a result of certain factors. See "Management's Discussion and Analysis of
Financial Condition and Results of Operations -- Important Factors Regarding
Forward-Looking Statements."
SUMMARY OF HISTORY AND RECENT DEVELOPMENTS
Alkermes Clinical Partners, L.P. (the "Partnership") was formed in
February 1992 under the laws of the State of Delaware. The Partnership operates
pursuant to an Agreement of Limited Partnership, dated as of February 7, 1992,
as amended. The sole general partner of the Partnership, Alkermes Development
Corporation II, a Delaware corporation (the "General Partner"), is a wholly
owned subsidiary of Alkermes, Inc. ("Alkermes" or the "Company"). PaineWebber
R&D Partners III, L.P. has the right to elect at least 50% of the directors of
the General Partner. The Limited Partners of the Partnership are investors who
purchased Class A and Class B Limited Partnership interests in the Partnership
in a private placement that closed in April 1992 and their transferees (the
"Limited Partners"). The Partnership does not have a website.
The principal objective of the Partnership has been to develop and
derive income from the sale or license of a family of molecules designated by
Alkermes as Receptor-Mediated Permeabilizers(TM) ("RMPs(TM)") for human
pharmaceutical use in the United States and Canada. Cereport(R), formerly known
as RMP-7(TM), is designed to facilitate drug delivery to the central nervous
system and is the Partnership's principal product candidate.
To further this objective, the Partnership provided funding to Alkermes
for research and development expenses for Cereport from approximately $42
million in capital contributions received from the Limited Partners. Funding to
Alkermes ended during the quarter ended June 30, 1996 when such capital
contributions were substantially depleted. None of the partners of the
Partnership is obligated to make any further capital contributions. Since the
funding was not sufficient to complete clinical trials and seek regulatory
approval of Cereport, Alkermes has used in excess of $30 million of its own and
its collaborator's resources to continue the development of Cereport. In 1997,
Alkermes actively sought a collaborative partner to provide funding for the
development of Cereport and to participate in the commercialization of Cereport
if it were successfully developed and ultimately entered into an agreement for
the development and commercialization of Cereport with ALZA Corporation
("ALZA"). In 1999 and 2000, Alkermes submitted to ALZA information regarding the
results of clinical trials and other data to seek ALZA's decision to move ahead
with its involvement in the development of Cereport. In June 2001, ALZA was
acquired by Johnson & Johnson ("J&J"), becoming a wholly owned subsidiary of
J&J. In December 2002, ALZA decided it had no interest in continuing development
of Cereport and mutually terminated the agreement with Alkermes.
All clinical trials for Cereport have been completed or
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discontinued except for one clinical trial being conducted by the
Children's Oncology Group, which is currently winding down. To date,
although analysis of clinical data showed some clinical activity, there has
been no clinical demonstration of efficacy sufficient for registration with any
regulatory authority.
As a result of the difficulties encountered in the development of
Cereport, including the clinical trial results and the termination of the
agreement with ALZA, Alkermes has determined that development of Cereport is not
economically feasible and, therefore, will not commit additional funds to the
development of Cereport. Alkermes notified the Limited Partners of this decision
in a March 2003 letter. There are a series of consequences that flow from this
decision. First, the Research Program under the product development agreement
between the Partnership and Alkermes will terminate as will the Purchase Option.
Second, the Technology (in the Field of Activity and in the Territory) will
revert to the Partnership and the Partnership will be free to license, assign or
otherwise transfer the Technology. Third, Alkermes' obligation to develop the
Technology will cease. Fourth, Alkermes' obligations to manufacture and market
any resulting Products will cease upon the earlier of (i) eighteen months after
termination of the Purchase Option and (ii) the sale or license of the
Technology. See "The Development and Purchase Agreements" for definitions of
capitalized terms and further discussion of Alkermes' rights and obligations.
The Partnership does not have the resources or capability required to develop
the Technology or market any resulting products on its own.
The General Partner must examine the various options available to the
Partnership given these events and consequences. Options being explored by the
General Partner include attempting to find a new collaborator to develop the
Technology (in the Field of Activity and in the Territory) and market any
resulting Products, selling such Technology or terminating the Partnership.
Based on the lack of widespread interest of potential collaborators in 1997 and,
to a greater degree, on the clinical trial results and difficulties encountered
in the development of Cereport since that time, the General Partner may not be
able to find a collaborator or a buyer for such Technology. Additionally, sale
or license of the Technology or a termination of the Partnership (absent a sale
or license of the Technology), would require approval of 66 2/3% of the
partners, which approval may be difficult to obtain. Whether or not the
Partnership terminates and in what manner it terminates may have tax
implications for the Limited Partners. Limited Partners should consult their own
tax advisors regarding any tax implications.
THE DEVELOPMENT AND PURCHASE AGREEMENTS
The Partnership entered into a product development agreement, dated as
of March 6, 1992, with Alkermes (the "Product Development Agreement") pursuant
to which Alkermes granted certain licenses to the Partnership and Alkermes
agreed to perform certain development and marketing obligations. Alkermes
entered into a purchase agreement, dated as of March 6, 1992 (the "Purchase
Agreement"), with each investor in the private placement in 1992 and the Class B
Limited Partner, pursuant to which Alkermes can exercise a right to purchase all
the outstanding partnership interests of all the partners.
Pursuant to the Product Development Agreement, Alkermes granted to the
Partnership an exclusive, royalty-free license to certain patent rights and
other technology owned or controlled by the Company related to RMPs (the
"Background Technology"). The license granted to the Partnership is limited to
Background Technology necessary or materially useful for the development and
commercialization of products based on RMPs (each a "Product") for human
pharmaceutical use (the "Field of Activity") in the United States and Canada
(the "Territory"). The Partnership granted to Alkermes an exclusive,
royalty-free license to all patent rights and other technology arising from
research and development conducted under the Product
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Development Agreement (the "Program Technology" which, taken together with the
Background Technology, comprises the "Technology") for exploitation outside the
Field of Activity and outside the Territory. Finally, the Partnership granted to
the Company a royalty-bearing right and license to make, use, modify and improve
the Technology within the Field of Activity and within the Territory (the
"Interim License"). In the event the Company commercialized a Product, the
Company would be obligated to pay certain royalties based on sales in the
Territory and in Europe of such Product and in certain circumstances on sales in
Europe of competitive products.
Alkermes agreed, pursuant to the Product Development Agreement, to the
extent permitted by Partnership funds (including the funds which the Company
elected to contribute to the development of Cereport), to use its best efforts
to perform the research and development necessary to engage in the Field of
Activity in the Territory (the "Research Program"). Through June 30, 1996, the
Partnership reimbursed Alkermes for its research and development expenses on
behalf of the Partnership and paid a management fee equal to ten percent (10%)
of such expenses.
The Partnership's funds were expended and no United States Food and
Drug Administration ("FDA") marketing approval was received for the sale by or
on behalf of the Partnership of any Product in the Field of Activity. In this
circumstance, the Product Development Agreement provides that the General
Partner is to determine the amount of additional funds required by the
Partnership in the upcoming year, and the Company will have the right, in its
sole discretion, to contribute such funds to the Partnership or to pay such
funds in any manner to which the Company and the General Partner agree
(including the direct payment of research and development expenses). Until
recently, the Company paid the research and development expenses of the
Partnership directly. However, Alkermes has decided not to commit any additional
funds to the development of Cereport.
Pursuant to the Product Development Agreement, the Company agreed to
use its best efforts to manufacture and market the Products in the Field of
Activity directly or through third parties in the United States and Canada in
accordance with the marketing program approved by the Board of Directors of the
General Partner (the "Marketing Program"). Pursuant to the Purchase Agreement,
as defined below, the Company agreed to use its best efforts to manufacture
Products and to sell the Products for use in the Field of Activity within the
Territory. If the Company determines that such manufacture and sale is not
commercially practicable, it has agreed to use its best efforts to license or
sell the Technology to a third party for the highest consideration that, in
Alkermes' reasonable business judgment, is obtainable.
The Company's obligations to develop Cereport or any other Product will
cease and the Purchase Option (as defined below) will terminate if at any time
at least 75% of the directors of the General Partner determine that the Research
Program is infeasible or uneconomic and should be discontinued with respect to
all Products or if the Company decides not to contribute the additional funds to
the Partnership which are determined by the General Partner to be required when
all Partnership funds have been expended and no FDA marketing approval has been
received for the sale of any Product in the Field of Activity. Furthermore, the
Company's obligations to manufacture and market Cereport or any other Product
will cease and the Purchase Option will
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terminate if at least 75% of the directors of the General Partner determine to
discontinue the Marketing Program with respect to all Products or upon the
earlier of (i) eighteen months after termination of the Purchase Option and (ii)
the sale or license of the Technology. The directors of the General Partner
intend to convene a meeting in the near future to discuss the feasibility of the
Research Program and the Marketing Program. Nevertheless, Alkermes has informed
the General Partner that it will not commit additional funds to the development
of Cereport and, therefore, will cause a termination of the Research Program,
the Purchase Option and, in turn, the Marketing Program.
Under the terms of the Purchase Agreement, each Limited Partner granted
to the Company an irrevocable option (the "Purchase Option") to purchase his,
her or its interest in the Partnership (a "Partnership Interest"). The Purchase
Option is exercisable only if all Partnership Interests are to be purchased and
such option is exercised pursuant to certain conditions set forth in the
Purchase Agreement generally related to the first commercial sale of a Product.
If the Purchase Option were exercised, Alkermes would be obligated to make a
certain lump sum payment to each Limited Partner (which could be paid in
Alkermes common stock) as well as royalties based on sales of Products.
The Purchase Option terminates upon the occurrence of any of the
following termination events: (i) the bankruptcy of the Company or the
Partnership, (ii) the cessation of operations by the Company, (iii) the seizure
or attachment of all or a substantial part of the Company's assets, (iv) the
termination of the Research Program or the Marketing Program, (v) the Company's
notice to the Partnership and the Limited Partners that it does not intend to
exercise the Purchase Option, or (vi) the expiration unexercised of the Purchase
Option. As described above, Alkermes has informed the General Partner that it
will not commit additional funds to the development of Cereport and, therefore,
will cause a termination of the Research Program, the Purchase Option and, in
turn, the Marketing Program. Upon any such termination, the Partnership will be
free to license, assign or otherwise transfer the Technology in the Field of
Activity and in the Territory.
CEREPORT
Cereport, a member of the family of RMPs, is a nine amino acid peptide
based on bradykinin, a compound occurring naturally in the body and known to
affect vascular permeability. Cereport is a proprietary, synthetic analog of
bradykinin developed to increase transiently the permeability of the blood-brain
barrier. Following injection, Cereport increases permeability by triggering a
brief relaxation of the tight cellular junctions of the blood-brain barrier.
During the time the tight junctions are relaxed, permeability is increased and
drug molecules in the bloodstream can diffuse into the brain in concentrations
greater than can usually be achieved without Cereport. Preclinical and clinical
data also suggested that Cereport could be administered at doses that
selectively increase permeability in the region of brain tumors and other
pathology.
Cereport exerts a pharmacologic effect on the vasculature of the brain
and does not itself bind to or serve as a carrier for the drug of which it is
facilitating delivery. Cereport was designed to be marketed as an independent
agent to increase the utility of other therapeutic and diagnostic compounds
given with it. In the clinical setting, Cereport was administered in conjunction
with a therapeutic or diagnostic agent. Timing of Cereport administration
relative to
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that of the therapeutic or diagnostic agent has to be determined on a drug by
drug basis to attempt to optimize barrier permeability during the time of peak
drug plasma concentrations.
BRAIN TUMOR
Current treatment for brain tumor is limited and inadequate. Standard
treatment typically involves surgery to remove cancerous tissue, followed by
radiation therapy. After initial treatment with surgery and/or radiotherapy,
brain tumors often recur. Upon recurrence, tumors typically progress rapidly,
neurological function and quality of life deteriorate and patients die within
months. Chemotherapy has played only a limited role in treatment, in part due to
the limited access of many chemotherapeutic agents to the brain because of the
normally restrictive blood-brain barrier. Carboplatin is a chemotherapeutic
approved for use by the FDA and other regulatory authorities worldwide for use
in the treatment of various tumor types outside of the brain, but is limited in
its ability to penetrate into the brain. The goal of the Cereport development
program was to enable more effective use of chemotherapeutic agents like
carboplatin in the treatment of brain tumors by transiently increasing the
permeability of the blood-brain barrier.
CLINICAL TRIALS
In 2002, there were two remaining Cereport Phase II clinical trials
being conducted, one by the Pediatric Branch of the National Cancer Institute
("NCI") and one by the Children's Oncology Group. Of these two trials, one has
been discontinued and the other is in the process of winding down. A number of
other clinical trials were conducted that are described in more detail below.
However, all such other clinical trials for Cereport have been completed or
discontinued and no additional clinical trials are contemplated by the Company.
As discussed above, Alkermes has communicated to the Limited Partners and the
General Partner that it will stop funding the further development of Cereport
and terminate the Research Program. Without Alkermes or some other collaborator,
the Partnership has no resources or capability to conduct any clinical trials.
The General Partner's clinical strategy for Cereport had been to
establish a foundation of safety and pharmacologic effect of increasing
blood-brain barrier permeability prior to entering Phase III clinical trials of
Cereport administered in combination with carboplatin. Through the Phase I,
Phase I/II and Phase III clinical trials, Cereport was shown to have a good
safety profile in volunteers and patients. Transient flushing was the most
consistent adverse event noted and nausea and vomiting were determined to be the
dose limiting toxicity. There was no evidence of increased toxicity associated
with the combination of Cereport and carboplatin, and the drug combination was
generally well tolerated by patients. To date, although analysis of clinical
data showed some clinical activity, there has been no clinical demonstration of
efficacy sufficient for registration with any regulatory authority.
RECURRENT MALIGNANT GLIOMA
Based on the successful completion of Phase I and Phase I/II clinical
trials, Alkermes initiated multiple Phase II clinical trials both of intravenous
and intra-arterial Cereport and carboplatin in patients with recurrent malignant
glioma. Three multi-center Phase II clinical trials of intravenous Cereport and
carboplatin and one multi-center Phase II clinical trial of intra-arterial
Cereport and carboplatin were completed. The results of the three Phase II
intravenous Cereport clinical trials provided the basis for the Company's
decision to proceed in the United
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States and Europe into study ALK01-040, a Phase III clinical trial of
intravenous Cereport and carboplatin in patients with newly diagnosed brain
tumors.
NEWLY DIAGNOSED BRAIN TUMOR
In March 1998, the study ALK01-040, which was a Phase III clinical
trial of Cereport and carboplatin for the treatment of newly-diagnosed brain
tumor patients began enrollment. It was designed to enroll patients with high
grade primary brain tumors following surgical resection of the tumor and prior
to the initiation of radiotherapy. In April 1999, Alkermes announced its plans
to discontinue study ALK01-040. The discontinuation of the study was based on
the Company's determination that elements of the study design were inappropriate
and that the probability of successful completion was low.
METASTATIC BRAIN TUMOR
Alkermes conducted a Phase I/II clinical trial of Cereport and
carboplatin in patients with metastatic brain tumors, or tumors that have spread
to the brain from other sites in the body. The study also included a dose
escalation component, in which progressively larger doses of Cereport were being
investigated in this patient population. The clinical trial phase of this study
was completed in 1999. In 2000, the results of this trial were presented to ALZA
pursuant to the development and commercialization agreement with ALZA, which
agreement was mutually terminated in December 2002. See "Collaboration with ALZA
Corporation" below.
PEDIATRIC BRAIN TUMOR
In August 1999, the NCI completed one study of Cereport and carboplatin
in pediatric patients with primary brain tumors. This study began in August 1996
and enrolled 25 patients. The study was a non-controlled, open label Phase I/II
clinical trial of intravenous Cereport and carboplatin in pediatric brain tumor
patients who had failed other therapies. The NCI began a second study in June
1998 that was discontinued in late 2002. This second study was a Phase II
multi-center study in pediatric brain tumor patients.
An investigator sponsored investigational new drug application to study
the radiosensitization effect of Cereport and carboplatin given with radiation
therapy in pediatric brain stem gliomas began in 2001. This study is being
managed by the Children's Oncology Group in coordination with the NCI. This
study is in the process of winding down and has stopped enrolling patients.
Alkermes has agreed to provide some additional amounts of Cereport for use in
the study which amounts are already manufactured and held by Alkermes. The
discontinuation and winding down of these pediatric studies was based on
Alkermes' determination that the clinical development of Cereport is not
economically feasible.
COLLABORATION WITH ALZA CORPORATION
In 1997, Alkermes actively sought a collaborative partner to provide
funding for the development of Cereport and to participate in the
commercialization of Cereport if it were successfully developed and approved.
The effort included a mailing to a number of prospective collaborators as
well as targeted efforts at certain biotechnology and pharmaceutical companies.
This effort generated little interest.
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However, in late 1997, Alkermes and ALZA entered into an agreement
relating to the development and commercialization of Cereport. Under the terms
of the agreement, ALZA made a $10.0 million upfront payment to Alkermes to fund
clinical development; in return, ALZA had the option to acquire exclusive
worldwide commercialization rights to Cereport, subject to the rights and
obligations of the Partnership. In 1999 and 2000, Alkermes presented final
reports to ALZA of Phase II clinical trials and other data regarding the use of
Cereport in combination with carboplatin for the treatment of brain tumors.
During 2001, ALZA was acquired by J&J and is now a wholly owned subsidiary of
J&J. In December 2002, ALZA decided it had no interest in continuing development
of Cereport and agreed to a mutual termination of the agreement with Alkermes.
Based on the lack of widespread interest of potential collaborators in 1997 and,
to a greater degree, on the high cost expected to be associated with
establishing clinical efficacy of Cereport necessary to obtain registration with
regulatory authorities, it may be difficult to find another collaborator.
PATENTS AND PROPRIETARY RIGHTS
The Partnership's success will be dependent, in part, on its ability
to obtain patent protection for the Partnership's Products, to maintain trade
secret protection and to operate without infringing upon the proprietary rights
of others.
Pursuant to the Product Development Agreement, the Company has agreed
to file patent and similar applications that it believes in its reasonable
business judgment are necessary or useful to protect the Partnership's interest
in the Technology and has agreed to use reasonable diligence to prosecute and
maintain in force such applications and any resultant patents or similar rights
at the Partnership's expense to the extent such applications relate to
Technology in the Field of Activity in the Territory. This obligation will cease
upon the earlier of (i) the sale or license of the technology licensed to the
Partnership and (ii) eighteen months after termination of the Purchase Option.
Since the Partnership funds were fully expended in mid-1996, Alkermes has paid
all patent expenses without reimbursement from the Partnership. Pursuant to the
Product Development Agreement, Alkermes has abandoned the patents and patent
applications relating to the RMP technology in foreign countries, filed at its
expense, based on its reasonable business judgment that any commercial value in
such patents and patent applications is outweighed by the expense of maintaining
and pursuing such patents and patent applications.
The Partnership has rights under five United States patents directed to
composition of matter as well as processes of preparation and methods of use,
including patents relating to permeabilizers, of which one United States patent
was issued in each of May 1992, December 1993, April 1996, December 1996 and
November 1997. None of the United States patents is expected to expire prior to
2010.
The Company has the right, in certain circumstances, but not the
obligation, to bring patent infringement actions against third parties that
infringe any of the Partnership's rights with respect to the Technology.
However, because the Company has determined that development of Cereport is not
economically feasible and the Research Program and the Purchase Option will
therefore terminate, the Company does not intend to bring any such actions in
the future. Therefore, the enforcement of patents against third party infringers
will be an obligation of the Partnership.
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The Partnership does not have the substantial resources necessary to bring a
patent infringement action or otherwise bring an action to protect its
proprietary rights against third parties.
Two United States patents have issued to a third party in the United
States and in Europe that contain claims covering certain analogs and uses
thereof of the same naturally occurring molecule on which Cereport is based.
There can be no assurance that the claims of the issued United States patents
will not be infringed by the Partnership's or any collaborator's proposed
manufacture, use or sale of Cereport. There can be no assurance that the
Partnership would prevail in any legal action seeking damages or injunctive
relief for infringement of the patents or that any license required under such
patents would be made available or, if available, would be available on
acceptable terms. The Company is obligated to defend any such suit or action for
eighteen months after termination of the Purchase Option at the Company's
expense. The Partnership does not have the substantial resources necessary to
defend any such action on its own should a third party collaborator not be
obligated to incur such expense on its behalf. Furthermore, there can be no
assurance that any licenses under any patents would be made available on
commercially viable terms, if at all. Failure to obtain a required license could
result in the inability to proceed with RMP-based products.
The patent positions of holders of technology similar to the
Technology, such as pharmaceutical, biopharmaceutical and biotechnology firms,
are generally uncertain and involve complex legal and factual questions. In
addition, there can be no assurance that the claims of the patents issued in
connection with the Partnership's Technology will be sufficiently broad to cover
the Products developed by the Partnership or its future collaborators, if any,
or to provide the Partnership with any competitive advantages. Moreover, no
assurance can be given that patents issued in connection with the Partnership's
product candidate will not be contested, narrowed, invalidated or circumvented.
Pharmaceutical, biopharmaceutical and biotechnology companies also rely
upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to develop and maintain their competitive
position which they seek to protect, in part, by confidentiality agreements with
their corporate partners, collaborators, employees and consultants. There can be
no assurance that these agreements will not be breached, that the Partnership
would have adequate remedies for any breach, or that the Partnership's trade
secrets will not otherwise become known or be independently discovered by
competitors.
Such Companies' practice is to require their employees, consultants and
advisors to execute a confidentiality agreement upon the commencement of an
employment or consulting relationship with the employer. The agreements provide
that all confidential information developed or made known to an individual
during the course of the employment or consulting relationship shall be
9
kept confidential and not disclosed to third parties except in specified
circumstances. In the case of employees, the agreements provide that all
inventions conceived by the individual while employed by the employer shall be
the exclusive property of such employer. There can be no assurance, however,
that these agreements will provide meaningful protection for the Partnership's
trade secrets in the event of unauthorized use or disclosure of such
information.
COMPETITION
The biotechnology and pharmaceutical industries are subject to rapid
and substantial technological change. The Partnership and any collaborator face,
and will continue to face, intense competition in the development,
manufacturing, marketing and commercialization of RMP product candidates from
academic institutions, government agencies, research institutions, biotechnology
and pharmaceutical companies, including its collaborators, and drug delivery
companies. The General Partner believes that there are currently no products
approved by the FDA for increasing the permeability of the blood-brain barrier.
There are, however, many novel experimental therapies for the treatment of brain
tumors and central nervous system infections being tested in the United States
and Europe. There can be no assurance that developments by others will not
render RMP product candidates or technologies obsolete or noncompetitive.
The Partnership does not have the resources, capability or experience
necessary to manufacture or market Cereport or any RMP product on its own. The
competitors and potential competitors of the Partnership have substantially
greater capital resources, manufacturing and marketing experience, research and
development resources and production facilities. These competitors also have
significantly greater experience than the Partnership in undertaking preclinical
testing and clinical trials of new pharmaceutical products and obtaining FDA and
other regulatory approvals. There can be no assurance that the Partnership will
be able to compete successfully with such companies. The existence of products
developed by the Partnership's competitors, or other products or treatments of
which the General Partner is not aware, or products or treatments that may be
developed in the future, may adversely affect the marketability of products
developed by the Partnership.
MANUFACTURING AND MARKETING
Cereport is a small peptide manufactured using standard synthetic
techniques. Alkermes has relied on an independent European pharmaceutical
company for the manufacture and supply of Cereport. However, due to the
anticipated termination of Alkermes' obligation to manufacture Cereport on
behalf of the Partnership, the Partnership or a future collaborator will have
to either enter into an agreement with a third party manufacturer for the
manufacture of Cereport or manufacture Cereport itself. The General Partner
believes that, if necessary, there are companies with which the Partnership
could contract to manufacture and supply the requirements for Cereport.
Nevertheless, there can be no assurance that any manufacturer of Cereport will
meet demands for quality, quantity, cost and timeliness of delivery.
Because of the anticipated termination of the Research Program and
Marketing Program in addition to the termination of the agreement with ALZA, the
Partnership would have to either market Cereport on its own or find another
collaborator. Because the Partnership does not have the resources, capability or
experience necessary to market on its own, the Partnership must enter into
arrangements with third parties to market and sell its products in order to
achieve commercial success for any product candidate approved by the FDA. There
can be no assurance
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that the Partnership will be able to enter into marketing and sales agreements
with others on acceptable terms, if at all. To the extent that the Partnership
enters into co-promotion or other sales and marketing arrangements with other
companies, any revenues received by the Partnership will be dependent on the
efforts of others, and there can be no assurance that such efforts will be
successful.
GOVERNMENT REGULATION
The manufacture and marketing of pharmaceutical products in the United
States require the approval of the FDA under the Federal Food, Drug and Cosmetic
Act. Similar approvals by comparable agencies are required in Canada. The FDA
has established mandatory procedures and safety standards which apply to the
preclinical testing and clinical trials, manufacture and marketing of
pharmaceutical products. Pharmaceutical manufacturing facilities are also
regulated by state, local and other authorities.
As an initial step in the FDA regulatory approval process, preclinical
studies are typically conducted in animal models to assess the drug's efficacy
and to identify potential safety problems. The results of these studies must be
submitted to the FDA as part of an Investigational New Drug application ("IND"),
which must be reviewed by the FDA before proposed clinical testing can begin.
Typically, clinical testing involves a three-phase process. Phase I trials are
conducted with a small number of subjects and are designed to provide
information about both product safety and the expected dose of the drug. Phase
II trials are designed to provide additional information on dosing and
preliminary evidence of product efficacy. Phase III trials are large scale
studies designed to provide statistical evidence of efficacy and safety in
humans. The results of the preclinical testing and clinical trials of a
pharmaceutical product are then submitted to the FDA in the form of a New Drug
Application ("NDA"), or for a biological product in the form of a Product
License Application ("PLA"), for approval to commence commercial sales.
Preparing such applications involves considerable data collection, verification,
analysis and expense. In responding to an NDA or PLA, the FDA may grant
marketing approval, request additional information or deny the application if it
determines that the application does not satisfy its regulatory approval
criteria.
Prior to marketing, any product developed by the Partnership must
undergo an extensive regulatory approval process, which includes preclinical
testing and clinical trials of such product candidate to demonstrate safety and
efficacy. This regulatory process can require many years and the expenditure of
substantial resources. Data obtained from preclinical testing and clinical
trials are subject to varying interpretations, which can delay, limit or prevent
FDA approval. In addition, changes in FDA approval policies or requirements may
occur or new regulations may be promulgated which may result in delay or failure
to receive FDA approval. Delays and costs in obtaining regulatory approvals
would have a material adverse effect on the Partnership's business, financial
condition and results of operations.
Among the conditions for NDA or PLA approval is the requirement that
the prospective manufacturer's quality control and manufacturing procedures
conform on an ongoing basis with Good Manufacturing Process ("GMP"). Before
approval of an NDA or PLA, the FDA will perform a prelicensing inspection of the
facility to determine its compliance with GMP and other rules and regulations.
In complying with GMP, manufacturers must continue to expend time,
11
money and effort in the area of production and quality control to ensure full
technical compliance. After the establishment is licensed, it is subject to
periodic inspections by the FDA.
The requirements which the Partnership must satisfy to obtain
regulatory approval by governmental agencies in Canada and prior to
commercialization of its products in Canada can be as rigorous and costly as
those described above. Because the Partnership does not have the resources,
capability or experience necessary to obtain regulatory approval on its own, the
Partnership must enter into arrangements with third parties in order to obtain
such regulatory approvals. There can be no assurance that the Partnership will
be able to enter into such arrangements.
The Partnership and any collaborator is also subject to various laws
and regulations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and
disposal of hazardous or potentially hazardous substances, including radioactive
compounds and infectious disease agents, used in connection with the
Partnership's research.
EMPLOYEES
The Partnership and the General Partner do not have any employees.
Historically, Alkermes employees have performed services on behalf of the
Partnership and the General Partner. As previously discussed, Alkermes has
informed the General Partner that it does not intend to further support the
Research Program.
ITEM 2. PROPERTIES
The Partnership and the General Partner do not own or lease any
property. Historically, the General Partner and the Partnership have utilized
the properties leased by Alkermes. As previously discussed, Alkermes has
informed the General Partner that it does not intend to further support the
Research Program.
ITEM 3. LEGAL PROCEEDINGS
Not applicable.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable.
12
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
There is no trading market for the Limited Partnership Interests,
public or otherwise. Any transfer of a Limited Partnership interest is severely
restricted by certain conditions outlined in the Partnership Agreement, and
requires the consent of the General Partner which can be withheld in its sole
discretion.
As of March 17, 2003, there was one holder of a General Partnership
Interest, one holder of a Class B Partnership Interest and 1,106 holders of
Class A Partnership Interests.
There have been no cash distributions to the partners to date.
Distributions in the future, if any, will be made by the General Partner or any
successor general partner to the partners as soon as practicable after the end
of any fiscal quarter, in proportion to the partners' respective capital
accounts as of the end of such quarter. Distributable cash, which must be
distributed to the partners, is generally defined as the excess of cash revenues
over certain expenditures and other amounts determined by the General Partner or
any successor general partner to be necessary for the proper operation of the
Partnership's business. The capital account of each partner will be increased by
such partner's cash contributions (net of selling commissions, investment
banking fees, warrant valuation fees and financial advisory fees allocated to
the Partner) to the Partnership decreased by the amount of any cash distribution
and the fair market value of other property from the Partnership to such
partner, and increased or decreased by such partner's allocation of the net gain
or loss of the Partnership for Federal income tax purposes ("Profits" and
"Losses," respectively). Partnership profits and losses are allocated 99% to the
Limited Partners (pro rata to their capital accounts) and 1% to the General
Partner.
13
ITEM 6. SELECTED FINANCIAL DATA
Year Ended December 31,
--------------------------------------------------------------------
1998 1999 2000 2001 2002
-------- -------- -------- -------- --------
Statements of Operations
Data (1):
Total Revenues $ -- $ -- $ -- $ -- $ --
Total Expenses 29,348 44,112 37,870 23,953 40,693
-------- -------- -------- -------- --------
Net Loss (29,348) (44,112) (37,870) (23,953) (40,693)
======== ======== ======== ======== ========
Net Loss Per Class A
and B Unit $ (--) $ (--) $ (--) $ (--) $ (--)
======== ======== ======== ======== ========
Average Class A and B Units
Outstanding 921 921 921 921 921
======== ======== ======== ======== ========
1998 1999 2000 2001 2002
-------- -------- -------- -------- --------
Balance Sheets Data:
Total Assets $ -- $ -- $ -- $ -- $ --
Long-term Obligations -- -- -- -- --
(1) The Partnership did not make any cash distributions to its partners during
any of the periods presented.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
INTRODUCTION
The Partnership was formed on February 7, 1992, and is managed by its
general partner, Alkermes Development Corporation II (the "General Partner"), a
wholly owned subsidiary of Alkermes. The Partnership was organized to fund the
further development and clinical testing of a family of molecules, designated by
Alkermes as RMPs, for human pharmaceutical use in the United States and Canada.
IMPORTANT FACTORS REGARDING FORWARD-LOOKING STATEMENTS
Any statements set forth below or otherwise made in writing or orally
by the Partnership or the General Partner with regard to its expectations as to
financial results and other aspects of its business may constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements can be identified by
forward-
14
looking words such as "may," "will," "expects," "anticipates," "believes,"
"estimates," "continues" or similar words. Although the General Partner believes
that its expectations are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, there can be no assurance that
actual results of the Partnership's development activities and its results of
operations will not differ materially from its expectations. Factors which could
cause actual results to differ from expectations depend on the direction taken
by the Partnership at the direction of the General Partner. The General Partner
must examine and act upon its options given Alkermes' decision that it will not
commit additional funds to the development of Cereport(R) and therefore cause a
termination of the Research Program and the Purchase Option. Risk factors
related to the options available include, among others:
(i) a new collaborator or a buyer of the Technology may be difficult to
find, due to the mutual termination of the agreement between ALZA Corporation
and Alkermes, the difficulties encountered in developing Cereport and the
general economic conditions at this time;
(ii) even if a third party were interested in acting as a new
collaborator, the economic and other terms may not be commercially acceptable;
(iii) even if a buyer of the Technology licensed to the Partnership
were to be found, the purchase price paid may be significantly lower than an
amount, after payment of expenses of the transaction and distribution to the
partners, required to return each partner's investment in the Partnership;
(iv) any license or sale of the Technology requires the approval of
66 2/3% of the partners, which approval may be difficult to obtain;
(v) in the event that no collaborator or buyer is found for the
Technology, or no agreement can be reached on commercial terms, a termination of
the partnership requires the approval of 66 2/3% of the partners, which
approval may be difficult to obtain;
(vi) whether or not the Partnership terminates and in what manner it
terminates may have tax implications for the Limited Partners. Limited Partners
should consult their own tax advisors regarding any tax implications; and
(vii) the General Partner and the Partnership have no assets to pay any
expenses of the General Partner or the Partnership and, without financial
support from Alkermes or a new collaborator, there is substantial doubt about
the Partnership's ability to continue as a going concern.
If the General Partner were to find a new collaborator, there would be
significant risks related to the further development of Cereport, including,
among others:
(i) clinical trials for Cereport may not proceed as planned, the trials
may require more time to enroll patients than anticipated, and even if they are
completed Cereport could prove to be ineffective or unsafe;
(ii) the collaborator could reduce or discontinue funding of Cereport;
15
(iii) the Partnership and the collaborator could not be permitted by
regulatory authorities to undertake additional clinical trials for Cereport
or clinical trials could be delayed or regulatory authorities could require
additional clinical trials before approving Cereport;
(iv) the collaborator could incur difficulties or set-backs in
obtaining the substantial additional funding required to continue research and
development programs and clinical trials;
(v) even if Cereport appears promising at an early stage of
development, it could fail to receive necessary regulatory approvals, be
difficult to manufacture on a large scale, be uneconomical, fail to achieve
market acceptance, be precluded from commercialization by proprietary rights of
third parties or experience substantial competition in the marketplace; and
(vi) technological change in the biotechnology or pharmaceutical
industries and the approval of other drugs or therapies to treat brain tumors
could render Cereport obsolete or noncompetitive.
RESULTS OF OPERATIONS
Years ended December 31, 2002 and 2001
Revenue
The Partnership had no revenue for the years ended December 31, 2002
and 2001. The Partnership anticipates that it will have no revenues in the
foreseeable future.
Expenses
The Partnership had no research and development expenses for the years
ended December 31, 2002 and 2001. There were no research and development
expenses because of the completion of the development funding to Alkermes
pursuant to the product development agreement between Alkermes and the
Partnership (the "Product Development Agreement").
General and administrative expenses for the year ended December 31,
2002 were $40,693 as compared to $23,953 for the year ended December 31, 2001.
The increase was mainly a result of increased professional service fees. The
General Partner is obligated to perform general and administrative services for
the Partnership. Historically, Alkermes has performed these general and
administrative services for the Partnership on the General Partner's behalf at
Alkermes' expense. There can be no assurance that Alkermes will continue to
perform these services.
Years ended December 31, 2001 and 2000
Revenue
The Partnership had no revenue for the years ended December 31, 2001
and 2000. The Partnership anticipates that it will have no revenues in the
foreseeable future.
16
Expenses
The Partnership had no research and development expenses for the years
ended December 31, 2001 and 2000. There were no research and development
expenses because of the completion of the development funding to Alkermes
pursuant to the Product Development Agreement.
General and administrative expenses for the year ended December 31,
2001 were $23,953 as compared to $37,870 for the year ended December 31, 2000.
The decrease was mainly a result of decreased professional service fees. The
General Partner is obligated to perform general and administrative services for
the Partnership.
QUARTERLY FINANCIAL INFORMATION
The following table sets forth certain unaudited quarterly data of the
Partnership for each of the quarters during calendar years 2002 and 2001. This
information has been prepared on the same basis as the annual financial
statements and all necessary adjustments, consisting only of normal recurring
adjustments, have been included in the amounts stated below to present fairly
the selected quarterly information when read in conjunction with the annual
financial statements and the notes thereto included elsewhere in this document.
The quarterly operating results of the Partnership's operations are not
necessarily indicative of the results of the Partnership's operations for any
other interim period or for a full year.
17
QUARTERS ENDED
-------------------------------------------------------
MARCH 31, JUNE 30, SEPTEMBER 30, DECEMBER 31,
2002 2002 2002 2002
-------- -------- ------------- ------------
Revenue: $ -- $ -- $ -- $ --
-------- -------- -------- --------
Expenses:
General and administrative 4,793 2,947 4,130 28,823
-------- -------- -------- --------
4,793 2,947 4,130 28,823
-------- -------- -------- --------
Net Loss $ (4,793) $ (2,947) $ (4,130) $(28,823)
======== ======== ======== --------
Net Loss Per Class A and B Unit $ -- $ -- $ -- $ --
======== ======== ======== ========
Average Class A and B Units Outstanding 921 921 921 921
======== ======== ======== ========
QUARTERS ENDED
-------------------------------------------------------
MARCH 31, JUNE 30, SEPTEMBER 30, DECEMBER 31,
2001 2001 2001 2001
-------- -------- ------------- ------------
Revenue: $ -- $ -- $ -- $ --
-------- -------- -------- --------
Expenses:
General and administrative 2,043 1,916 4,887 15,107
-------- -------- -------- --------
2,043 1,916 4,887 15,107
-------- -------- -------- --------
Net Loss $ (2,043) $ (1,916) $ (4,887) $(15,107)
======== ======== ======== ========
Net Loss Per Class A and B Unit $ -- $ -- $ -- $ --
======== ======== ======== ========
Average Class A and B Units Outstanding 921 921 921 921
======== ======== ======== ========
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 2002, the Partnership had no remaining assets or
liabilities.
The Partnership's primary source of funding and capital resources had
been the annual capital contributions by the Limited Partners and the General
Partner. The Limited Partners' capital contributions were remitted to the
Partnership in four annual installments, the fourth and final payment of which
was due on April 15, 1995. There have been no additional capital contributions
received by the Partnership from the Limited Partners after the quarter ended
June 30, 1996 and no additional capital contributions from any of the partners
are required.
The Partnership was funding research and development expenses for
Cereport from capital contributions received from Partners. Such development has
been conducted for the Partnership by Alkermes pursuant to the Product
Development Agreement, although Alkermes
18
intends to cause a termination of the Research Program which would also
terminate its obligations to continue such development. The research and
development funding to Alkermes ended during the quarter ended June 30, 1996
when such capital contributions were substantially depleted. None of the
Partners is obligated to make any further capital contributions. Because the
funding was not sufficient for Alkermes to complete clinical trials and seek
regulatory approval of Cereport, Alkermes has used its own resources until its
recent decision not to commit any additional funds. In late 1997, Alkermes
entered into an agreement with ALZA Corporation related to the development and
commercialization of Cereport that was mutually terminated in December 2002.
The Partnership used its remaining cash and cash equivalents during the
quarter ended September 30, 1997 to pay for administrative services for the
Partnership. The General Partner is obligated to perform certain administrative
services for the Partnership, such as preparing financial statements, tax
returns and reports to the Limited Partners. Historically, Alkermes has
performed such services on behalf of the General Partner at its expense. There
can be no assurance that Alkermes will continue to perform these services. The
activities performed by Alkermes and the General Partner constitute all of the
activities undertaken by or on behalf of the Partnership.
After December 31, 2002, the Partnership is expected to have no future
liquidity or capital resource requirements other than those funded by Alkermes,
if any.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
19
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA:
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
Financial Statements as of December 31, 2002 and 2001 and for
Each of the Three Years in the Period
Ended December 31, 2002 and Independent Auditors' Report
20
INDEPENDENT AUDITORS' REPORT
To the Partners of
Alkermes Clinical Partners, L.P.
Cambridge, Massachusetts
We have audited the accompanying balance sheets of Alkermes Clinical
Partners, L.P. (a Limited Partnership) as of December 31, 2002 and 2001, and the
related statements of operations, changes in partners' capital, and cash flows
for each of the three years in the period ended December 31, 2002. These
financial statements are the responsibility of the Partnership's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with auditing standards generally
accepted in the United States of America. Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, such financial statements present fairly, in all
material respects, the financial position of the Partnership as of December 31,
2002 and 2001, and the results of its operations and its cash flows for each of
the three years in the period ended December 31, 2002, in conformity with
accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that
the Partnership will continue as a going concern. As discussed in Note 6 to the
financial statements, the Partnership completed its development funding to
Alkermes, Inc. (an affiliate) and none of the partners are obligated to make any
further capital contributions to the Partnership. As a result, the Partnership
has no assets with which to fund operations and has been reliant on funding
received from the General Partner, who in turn has been reliant on voluntary
contributions from Alkermes, Inc. In addition, as discussed in Note 3, Alkermes,
Inc. has indicated that it will not commit additional funds to the development
of the Partnership's products; as a result, the General Partner has begun
discussions regarding strategic alternatives for the Partnership. These factors
raise substantial doubt about the Partnership's ability to continue as a going
concern. Management's plans concerning these matters are also described in Notes
3 and 6. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
/S/ DELOITTE & TOUCHE LLP
Boston, Massachusetts
March 21, 2003
21
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
BALANCE SHEETS
DECEMBER 31, 2002 AND 2001
- --------------------------------------------------------------------------------
2002 2001
------- -------
ASSETS
TOTAL ASSETS $ -- $ --
======= =======
LIABILITIES AND PARTNERS' CAPITAL
TOTAL LIABILITIES AND PARTNERS' CAPITAL $ -- $ --
======= =======
See notes to financial statements.
22
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2002, 2001 AND 2000
- --------------------------------------------------------------------------------
2002 2001 2000
-------- -------- --------
REVENUE: $ -- $ -- $ --
-------- -------- --------
EXPENSES:
General and administrative 40,693 23,953 37,870
-------- -------- --------
40,693 23,953 37,870
-------- -------- --------
NET LOSS $(40,693) $(23,953) $(37,870)
======== ======== ========
NET LOSS PER CLASS A AND B UNIT $ -- $ -- $ --
======== ======== ========
AVERAGE CLASS A AND B UNITS OUTSTANDING 921 921 921
======== ======== ========
See notes to financial statements.
23
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
STATEMENTS OF CHANGES IN PARTNERS' CAPITAL
YEARS ENDED DECEMBER 31, 2002, 2001 AND 2000
- --------------------------------------------------------------------------------
GENERAL
PARTNER TOTAL
-------- --------
BALANCE, JANUARY 1, 2000 $ -- $ --
General Partner's capital contributions 37,870 37,870
Net loss for year (37,870) (37,870)
-------- --------
BALANCE, DECEMBER 31, 2000 -- --
General Partner's capital contributions 23,953 23,953
Net loss for year (23,953) (23,953)
-------- --------
BALANCE, DECEMBER 31, 2001 -- --
General Partner's capital contributions 40,693 40,693
Net loss for year (40,693) (40,693)
-------- --------
BALANCE, DECEMBER 31, 2002 $ -- $ --
======== ========
See notes to financial statements.
24
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2002, 2001 AND 2000
- --------------------------------------------------------------------------------
2002 2001 2000
-------- -------- --------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $(40,693) $(23,953) $(37,870)
-------- -------- --------
Net cash used by operating activities (40,693) (23,953) (37,870)
-------- -------- --------
CASH FLOWS FROM FINANCING ACTIVITIES:
General Partner's capital contributions 40,693 23,953 37,870
-------- -------- --------
Net cash provided by financing activities 40,693 23,953 37,870
-------- -------- --------
NET CHANGE IN CASH -- -- --
CASH, BEGINNING OF YEAR -- -- --
-------- -------- --------
CASH, END OF YEAR $ -- $ -- $ --
======== ======== ========
See notes to financial statements.
25
ALKERMES CLINICAL PARTNERS, L.P.
(A LIMITED PARTNERSHIP)
NOTES TO FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 2002, 2001 AND 2000
- --------------------------------------------------------------------------------
1. ORGANIZATION AND BUSINESS OPERATIONS
Alkermes Clinical Partners, L.P. (the "Partnership") was formed on February 7,
1992 and is managed by its general partner, Alkermes Development Corporation II
(the "General Partner"), a wholly owned subsidiary of Alkermes, Inc.
("Alkermes"). The Partnership was organized to fund the further development and
clinical testing of a family of molecules, designated by Alkermes as
Receptor-Mediated Permeabilizers ("RMPs"), for human pharmaceutical use in the
United States and Canada.
On April 10, 1992, the Partnership and Alkermes sold in a private placement (i)
920 Class A units, each unit (a "Class A Unit") consisting of one Class A
Limited Partnership interest in the Partnership and warrants to purchase shares
of Alkermes common stock, and (ii) one Class B unit (the "Class B Unit")
consisting of one Class B Limited Partnership interest (the "Class B Interest")
in the Partnership and warrants to purchase shares of Alkermes common stock. The
purchase price was $50,000 for each Class A Unit, $10,718 of which was paid at
the time of subscription, and the balance of which was evidenced by an investor
note (each, an "Investor Note" and collectively, the "Investor Notes"), $12,372
of which was paid during 1993, $14,166 of which was paid during 1994 and the
remainder of which was paid in April 1995. The purchase price for the Class B
Unit was $100,000, $21,000 of which was paid at the time of subscription, and
the balance of which was evidenced by a promissory note, $24,744 of which was
paid during 1993, $28,332 of which was paid during 1994 and the remainder of
which was paid in April 1995. All warrants issued in the private placement have
been exercised or expired.
The net proceeds from the sale of the units were used primarily to fund the
further development and clinical testing of RMPs (the "Research Program"), which
development and testing has been conducted for the Partnership by Alkermes
pursuant to a product development agreement by and between Alkermes and the
Partnership (the "Product Development Agreement") (see Note 3). Cereport(R),
formerly known as RMP-7(TM), is a product candidate designed to facilitate drug
delivery to the central nervous system and is the Partnership's principal
product candidate.
26
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION - The Partnership prepares its financial statements on the
accrual basis of accounting.
USE OF ESTIMATES - The preparation of the Partnership's financial statements in
conformity with accounting principles generally accepted in the United States of
America necessarily requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amount of revenues and expenses during each of the reporting
periods. Actual results could differ from those estimates.
NET LOSS PER CLASS A AND B LIMITED PARTNERSHIP INTEREST - Net loss per Class A
and B Limited Partnership interest is calculated with the net loss attributable
only to the Limited Partners of the partnership (each, a "Limited Partner" and
collectively, the "Limited Partners") and excludes the loss attributable to the
General Partner. There were no losses attributable to the Limited Partners for
the years ended December 31, 2002, 2001 and 2000.
INCOME TAXES - Federal and state income taxes are the responsibility of the
General Partner and each of the Limited Partners of the Partnership.
Accordingly, no provision for income taxes has been recorded.
COMPREHENSIVE INCOME - There are no elements of other comprehensive income in
the financial statements.
3. PRODUCT DEVELOPMENT AGREEMENT
In March 1992, the Partnership entered into the Product Development Agreement
with Alkermes, pursuant to which Alkermes licensed to the Partnership certain
technologies of Alkermes relating to RMPs. The Partnership paid Alkermes a
nonrefundable fee of $1,750,000 under the Product Development Agreement for
prior research and costs incurred by Alkermes relating to RMPs and recorded such
fee as research and development expense in the period ended December 31, 1992.
The Partnership granted to Alkermes an exclusive interim license to manufacture
and market RMPs for human pharmaceutical use in the United States and Canada
(the "Interim License"). Pursuant to this Interim License, upon the first
marketing approval of an RMP product by the United States Food and Drug
Administration, the Partnership is to receive a payment from Alkermes equal to
20% of the aggregate capital contributions of all partners (the "Milestone
Payment"). Additionally, the Partnership is to receive royalty payments from
Alkermes equal to 12% of United States and Canadian revenues and 10% of European
revenues, in certain circumstances, from any sales of RMPs by Alkermes.
The Interim License and Alkermes' obligation to develop an RMP product will
terminate if the Research Program or Marketing Program terminate, which will
occur if at least 75% of the directors of the General Partner determine that the
Research Program is infeasible or uneconomic
27
and should be discontinued or 75% of the directors of the General Partner
determine to discontinue the Marketing Program or if Alkermes decides not to
contribute the additional funds to the Partnership which are determined by the
General Partner to be required when all Partnership funds have been expended and
no FDA marketing approval has been received for the sale of any RMP product. The
directors of the General Partner intend to convene a meeting in the near future
to discuss the feasibility of the Research Program and the Marketing Program.
However, Alkermes has determined that the development of Cereport is not
economically feasible and, therefore, it will not commit additional funds to its
development. This decision will cause a termination of the Research Program, the
Purchase Option and, in turn, the Marketing Program.
The General Partner is in the process of examining the various options available
to the Partnership given these events, which include attempting to find a new
collaborator to develop the technology licensed to the Partnership, selling such
technology or terminating the Partnership. The General Partner may not be able
to find a collaborator or a buyer. License or sale of the technology or a
termination of the Partnership (absent a license or sale of the technology),
would require approval of 66 2/3% of the partners.
The Partnership has rights under five issued patents: U.S. Patent No. 5,112,596
in May 1992, U.S. Patent No. 5,268,164 in December 1993, U.S. Patent No.
5,506,206 in April 1996, U.S. Patent No. 5,585,355 in December 1996 and U.S.
Patent No. 5,686,416 in November 1997.
4. PARTNERSHIP PURCHASE OPTION
In consideration for the warrants to purchase Alkermes common stock, each
Limited Partner has granted to Alkermes an option to purchase (the "Purchase
Option"), under certain circumstances, the Limited Partnership interest in the
Partnership held by such Limited Partner. Upon the exercise of the Purchase
Option, each owner of a Class A Limited Partnership interest (a "Class A Limited
Partner") will be entitled to receive an initial payment of, at the option of
Alkermes, $40,000 in cash or approximately $42,100 in Alkermes' common stock, as
well as certain additional payments (which are subject to certain limitations)
based on Alkermes' net revenues from sales of RMPs in the United States, Canada
and Europe (the "royalty stream") as follows:
- 12% of net revenues to Alkermes on sales of RMPs in the United States
and Canada and 10% of net revenues to Alkermes on sales of RMPs in Europe, until
each Class A Limited Partner has received an aggregate of $400,000 per interest
from the initial payment and the royalty stream; and thereafter,
- 9% of net revenues to Alkermes on sales of RMPs in the United States,
Canada and Europe, until each Class A Limited Partner has received an aggregate
of $500,000 per interest from the initial payment and the royalty stream; and
thereafter,
- 4% of net revenues to Alkermes on sales of RMPs in the United States,
Canada and Europe.
If Alkermes exercises the Purchase Option, the holder of the Class B Interest
(the "Class B Limited Partner") will receive, in addition to an advance payment
of $80,000, payable in cash or stock in the same manner as described above for
the Class A Limited Partners, quarterly
28
payments equal to (i) prior to the date on which the Class B Threshold (as
described below) occurs, the Class B Limited Partner's pro rata portion (based
upon the ratio that the Class B Limited Partner's capital contribution bears to
the aggregate capital contributions of all Limited Partners) of the royalties
described in the previous paragraph, and (ii) beginning on the date on which the
Class B Threshold occurs, the Class A Limited Partners will receive only 95% of
the above royalties. The Class B Threshold will occur on the first day of the
calendar quarter that follows the calendar quarter in which each Class A Limited
Partner will have received distributions in an aggregate amount equal to its
capital contribution.
Royalties on sales of RMPs in Europe will be payable only in certain
circumstances. The royalties described above will terminate on the last day of
the calendar quarter eleven years after Alkermes exercises the Purchase Option.
Alkermes may exercise the Purchase Option upon the earlier of: (i) the date that
is the later of the last day of the first month in which the Partnership shall
have received payments under the Interim License (excluding the Milestone
Payment) equal to 15% of the Limited Partners' capital contributions or the
expiration of 24 months after the first commercial sale of an RMP product under
the Interim License and (ii) the expiration of 48 months after the first
commercial sale of an RMP product under the Interim License.
The Purchase Option will terminate upon the occurrence of any of the following
termination events: (i) the bankruptcy of Alkermes or the Partnership, (ii) the
cessation of operations by Alkermes, (iii) the seizure or attachment of all or a
substantial part of Alkermes' assets, (iv) the termination of the Research
Program or the Marketing Program, (v) Alkermes' notice to the Partnership and
the Limited Partners that it does not intend to exercise the Purchase Option or
(vi) the expiration unexercised of the Purchase Option. As described in Note 3,
the Research Program has not yet terminated but Alkermes has indicated its
decision not to commit additional funds to the development of Cereport and
therefore its intention to cause a termination of the Research Program and the
Purchase Option.
5. PARTNERS' CAPITAL
The Partnership allocates its profits or losses for each fiscal year 1% to the
General Partner and 99% to the Limited Partners. The Partnership then allocates
the profits and losses allocated to the Limited Partners pro rata in accordance
with the Limited Partners' capital contributions, as adjusted for certain
allocations and returns to each Limited Partner. The capital contributions made
by each Class A Limited Partner and the Class B Limited Partner are discussed in
Note 1. Losses in excess of the Limited Partners' capital contributions are
allocated to the General Partner. If and when the Class B Threshold occurs (see
Note 4), the Partnership will allocate to the Class B Limited Partner 5% of
profits and losses allocated to the Limited Partners and will allocate to the
Class A Limited Partners 95% of profits and losses allocated to the Limited
Partners. Such allocation to the Class A Limited Partners will be made pro rata
based on such Limited Partners' capital contributions, as adjusted for certain
allocations and returns to such Limited Partners.
29
6. COMPLETION OF SCHEDULED FUNDING
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. For the years ended December 31,
2002, 2001 and 2000, the Partnership incurred no research and development
expenses related to the RMP program, notwithstanding the continued development
of the RMP product candidate. The Partnership was providing funding to Alkermes
for research and development expenses for Cereport from capital contributions
received from Partners. Funding to Alkermes ended during the quarter ended June
30, 1996 when such capital contributions were substantially depleted. None of
the Partners of the Partnership is obligated to make any further capital
contributions. Since the funding was not sufficient for Alkermes to complete
clinical trials and seek regulatory approval of Cereport, Alkermes has used its
own resources to develop Cereport. However, as discussed in Note 3, Alkermes has
decided not to commit additional funds to the development of Cereport.
The General Partner is obligated to perform certain administrative services for
the Partnership, such as preparing financial statements, tax returns and reports
to Partners. During 2002, 2001 and 2000, Alkermes performed such services for
the Partnership on behalf of the General Partner. There can be no assurance that
Alkermes will continue to perform these services. The services performed by
Alkermes and the General Partner constitute all of the activities undertaken by
or on behalf of the Partnership.
The financial statements do not include any adjustments relating to the amounts
and classification of liabilities that might be necessary should the Partnership
be unable to continue as a going concern. The Partnership's continuation as a
going concern is dependent upon its ability to generate sufficient cash flow to
meet its obligations on a timely basis, to obtain additional financing or
refinancing as may be required, and ultimately to attain successful operations.
After December 31, 2002, the Partnership is expected to have no future liquidity
or capital resource requirements other than those funded by Alkermes, if any.
30
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
Not applicable.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
(a) Directors of the General Partner.
Richard F. Pops, age 41, has been a director of the General Partner
since its inception in 1992. Mr. Pops has also been Chief Executive Officer and
a director of Alkermes since February 1991. From February 1991 to June 1994, Mr.
Pops was also President of Alkermes. Mr. Pops also serves on the Board of
Directors of Neurocrine Biosciences, Inc., the Biotechnology Industry
Organization (BIO), the Massachusetts Biotechnology Council (MBC), the New
England Healthcare Institute (NEHI) and Harvard Medical School Board of Fellows.
James M. Frates, age 35, has been a director of the General Partner
since June 1998. Mr. Frates has also been the Chief Financial Officer, Vice
President, Treasurer and Assistant Secretary of Alkermes since June 1998. From
June 1996 to July 1998, he was employed by Robertson Stephens & Company, most
recently as a Vice President. He received his M.B.A. from Harvard Business
School.
Stephen R. Dyer, age 43, has been a director of the General Partner
since December 12, 2002. Mr. Dyer is a Senior Vice President of UBS PaineWebber
Inc., having joined the firm in June 1988 as a Divisional Vice President. He
received his B.S. in Accounting from Boston College and his M.B.A. from Indiana
University. Mr. Dyer is a Certified Public Accountant.
Clifford B. Wattley, age 52, has been a director of the General Partner
since December 12, 2002. Mr. Wattley is a Corporate Vice President of
UBS PaineWebber Inc., having joined the firm in 1986. From 1986 to 1992, Mr.
Wattley participated in PaineWebber's Principal Transactions Group. Since 1992,
Mr. Wattley has been a member of the Private Investment Department. He holds a
B.S. degree in engineering from Columbia University and his M.B.A. from Harvard
Business School.
(b) Executive Officers of the General Partner.
Mr. Pops has been the President of the General Partner since its
inception and the Chief Executive Officer of the General Partner since 1993 when
the office of Chief Executive Officer was created.
31
Mr. Frates has been the Chief Financial Officer, Vice President,
Treasurer and Assistant Secretary of the General Partner since June 1998.
ITEM 11. EXECUTIVE COMPENSATION
The General Partner receives no compensation for performing its duties
under the Partnership Agreement. It will receive only its pro rata share of
Partnership distributions and distributions upon liquidation of the Partnership
and reimbursement for its expenditures for the payment of properly incurred
obligations of the Partnership. Furthermore, the officers and directors of the
General Partner receive no compensation other than reimbursement for appropriate
expenses incurred while conducting the business of the General Partner.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
Information regarding security ownership of all directors who own any
class of the Partnership's securities and all persons known to the Partnership
to be the beneficial owners of more than 5% of any class of the Partnership's
securities as of March 17, 2003 is as follows:
Name and Address of Percent of
Title of Class Beneficial Owner Beneficial Ownership Class
- -------------- --------------------- -------------------- ----------
General Partner Interest Alkermes Development One General Partner Interest 100.0%
Corporation II
88 Sidney Street
Cambridge, MA 02139
Class A Limited PaineWebber R&D Partners 133 Class A Limited 14.5%
Partnership Interests III, L.P. Partnership Interests
1285 Avenue of the
Americas
New York, NY 10019
Alkermes, Inc. 74 Class A Limited 8.0%
88 Sidney Street Partnership Interests
Cambridge, MA 02139
Class B Limited PaineWebber Development One Class B Limited 100.0%
Partnership Interest Corporation Partnership Interest
1285 Avenue of the Americas
New York, NY 10019
Exclusive management and control of the Partnership's business is
vested in the General Partner. As of March 17, 2003 none of the directors or
officers of the General Partner have any security ownership in the Partnership
other than as described above.
32
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Mr. Pops and Mr. Frates are officers of Alkermes and Mr. Pops is also a
director of Alkermes. In March 1992, the Partnership entered into certain
agreements with Alkermes, which are described above in Item 1. In the year ended
December 31, 2002, Alkermes made capital contributions to the Partnership,
through the General Partner, of $40,693 to cover all of the Partnership's
general and administrative expenses.
The purchase price for Class A Units was paid in four annual
installments. The final payment was due on April 15, 1995. The holders of 74
Class A Units failed to pay all of such payments and the Partnership foreclosed
on such units. In February and April 1996, Alkermes subsequently purchased these
Class A Units for approximately $2,052,000, the amount of the uncollected
payments. Such amount was recorded as equity inflows in 1996.
ITEM 14. CONTROLS AND PROCEDURES.
As of February 14, 2003, the chief executive officer and chief
financial officer of the General Partner evaluated the General Partner's
controls and procedures related to the Partnership's reporting and disclosure
obligations. These officers have concluded that these disclosure controls and
procedures are sufficient to provide that (a) material information relating to
the Partnership is made known to these officers by other employees of Alkermes,
the parent entity of the General Partner, and its consolidated subsidiaries,
particularly material information related to the period for which this periodic
report is being prepared; and (b) this information is recorded, processed,
summarized, evaluated and reported, as applicable, within the time periods
specified in the rules and forms promulgated by the Securities and Exchange
Commission.
There have been no significant changes in the General Partner's
internal controls or in other factors that could significantly affect these
controls subsequent to the date of the evaluation.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(b) During the quarter ended December 31, 2002 the Registrant has
not filed any reports on Form 8-K.
(c) Documents filed as part of the Report:
(1) Financial Statements of the Registrant and
Independent Auditors' Report thereon:
Independent Auditors' Report.
Balance Sheets, December 31, 2002 and 2001.
Statements of Operations for the Years Ended December
31, 2002, 2001, and 2000.
33
Statements of Changes in Partners' Capital for the
Years Ended December 31, 2002, 2001 and 2000.
Statements of Cash Flows for the Years Ended December
31, 2002, 2001 and 2000.
Notes to Financial Statements.
(2) Financial Statement Schedules:
Schedules have been omitted because of the absence of
conditions under which they are required or because
the required information is included in the financial
statements or the notes thereto.
(3) Exhibits
Exhibit
Number
- -------
3.1 Alkermes Clinical Partners, L.P. Agreement of Limited Partnership,
dated as of February 7, 1992.*
3.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of September 29, 1992.*
3.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of March 30, 1993.*
4.1 Alkermes Clinical Partners, L.P. Agreement of Limited Partnership,
dated as of February 7, 1992.*
4.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of September 29, 1992.*
4.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of March 30, 1993.*
10.1 Product Development Agreement, dated as of March 6, 1992, between the
Partnership and Alkermes.*
10.2 Purchase Agreement, dated as of March 6, 1992, by and among Alkermes
and each of the Limited Partners, from time to time, of the
Partnership.*
99.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, 18 U.S.C. Section 1350, by the Chief Executive Officer of
Alkermes Development Corporation II, General Partner of Alkermes
Clinical Partners, L.P.
34
99.2 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, 18 U.S.C. Section 1350, by the Chief Financial Officer of
Alkermes Development Corporation II, General Partner of Alkermes
Clinical Partners, L.P.
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
35
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
ALKERMES CLINICAL PARTNERS, L.P.
(Registrant)
By its General Partner
ALKERMES DEVELOPMENT
CORPORATION II
Date: March 31, 2003 By: /s/ Richard F. Pops
-------------------------------------
Richard F. Pops
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed by the following persons on behalf of the General Partner of the
Registrant on behalf of the Registrant and in the capacities and on the dates
indicated.
Signature Title Date
- --------- ----- ----
/s/ Richard F. Pops Director, President and Chief March 31, 2003
- --------------------------- Executive Officer (Principal
Richard F. Pops Executive Officer)
/s/ James M. Frates Director, Vice President, March 31, 2003
- --------------------------- Chief Financial Officer,
James M. Frates Treasurer and Assistant
Secretary (Principal Financial
and Accounting Officer)
/s/ Stephen R. Dyer Director March 31, 2003
- ---------------------------
Stephen R. Dyer
/s/ Clifford B. Wattley Director March 31, 2003
- ---------------------------
Clifford B. Wattley
36
CERTIFICATIONS
I, Richard F. Pops, certify that:
1. I have reviewed this annual report on Form 10-K of Alkermes Clinical
Partners, L.P.;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The other certifying officer of the General Partner and I are responsible
for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a. designed such disclosure controls and procedures to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this annual report
is being prepared;
b. evaluated the effectiveness of the registrant's disclosure controls
and procedures as of a date within 90 days prior to the filing date of
this annual report (the "Evaluation Date"); and
c. presented in this annual report our conclusions about the
effectiveness of the disclosure controls and procedures based on our
evaluation as of the Evaluation Date;
5. The other certifying officer of the General Partner and I have disclosed,
based on our most recent evaluation, to the registrant's auditors and the audit
committee of the registrant's board of directors (or persons performing the
equivalent function):
a. all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to
record, process, summarize and report financial data and have
identified for the registrant's auditors any material weaknesses in
internal controls; and
b. any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The other certifying officer of the General Partner and I have indicated in
this annual report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal controls
subsequent to the date of our most recent evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Date: March 31, 2003
/s/ Richard F. Pops
----------------------------------
Richard F. Pops
President and Chief Executive Officer
of Alkermes Development Corporation II,
General Partner of the Registrant
37
I, James M. Frates, certify that:
1. I have reviewed this annual report on Form 10-K of Alkermes Clinical
Partners, L.P.;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this annual
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this annual report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this annual report;
4. The other certifying officer of the General Partner and I are responsible
for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a. designed such disclosure controls and procedures to ensure that
material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this annual report
is being prepared;
b. evaluated the effectiveness of the registrant's disclosure controls
and procedures as of a date within 90 days prior to the filing date of
this annual report (the "Evaluation Date"); and
c. presented in this annual report our conclusions about the
effectiveness of the disclosure controls and procedures based on our
evaluation as of the Evaluation Date;
5. The other certifying officer of the General Partner and I have disclosed,
based on our most recent evaluation, to the registrant's auditors and the audit
committee of the registrant's board of directors (or persons performing the
equivalent function):
a. all significant deficiencies in the design or operation of internal
controls which could adversely affect the registrant's ability to
record, process, summarize and report financial data and have
identified for the registrant's auditors any material weaknesses in
internal controls; and
b. any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
controls; and
6. The other certifying officer of the General Partner and I have indicated in
this annual report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal controls
subsequent to the date of our most recent evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Date: March 31, 2003
/s/ James M. Frates
-------------------------------
James M. Frates
Vice President and Chief Financial Officer
of Alkermes Development Corporation II,
General Partner of the Registrant
38
ALKERMES CLINICAL PARTNERS, L.P.
ANNUAL REPORT ON FORM 10-K
EXHIBIT INDEX
Exhibit
Number Exhibit
- ------- -------
3.1 Alkermes Clinical Partners, L.P. Agreement of Limited Partnership,
dated as of February 7, 1992.*
3.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of September 29, 1992.*
3.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of March 30, 1993.*
4.1 Alkermes Clinical Partners, L.P. Agreement of Limited Partnership,
dated as of February 7, 1992.*
4.1(a) Amendment No. 1 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of September 29, 1992.*
4.1(b) Amendment No. 2 to Alkermes Clinical Partners, L.P. Agreement of
Limited Partnership, dated as of March 30, 1993.*
10.1 Product Development Agreement, dated as of March 6, 1992, between the
Partnership and Alkermes.*
10.2 Purchase Agreement, dated as of March 6, 1992, by and among Alkermes
and each of the Limited Partners, from time to time, of the
Partnership.*
99.1 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, 18 U.S.C. Section 1350, by the Chief Executive Officer of
Alkermes Development Corporation II, General Partner of Alkermes
Clinical Partners, L.P.
99.2 Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, 18 U.S.C. Section 1350, by the Chief Financial Officer of
Alkermes Development Corporation II, General Partner of Alkermes
Clinical Partners, L.P.
* Incorporated by reference to Exhibits to the Registrant's Registration
Statement on Form 10 filed September 13, 1995.
39