Exhibit 10.28

 

DEVELOPMENT AGREEMENT

BY AND BETWEEN

CORCEPT THERAPEUTICS

AND

FORMULATION TECHNOLOGIES L.L.C.

DATED AS OF

December 14, 2006

 

 

 

 

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Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as [ *** ]. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

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DEVELOPMENT AGREEMENT

This DEVELOPMENT AGREEMENT (this “Agreement”) is made and entered into effective
this 14th day of December, 2006 by and between Corcept Therapeutics
Incorporated, a Delaware corporation (“Corcept”), and Formulation Technologies
L.L.C., a Texas limited liability company d/b/a PharmaForm (“PharmaForm”).

RECITALS

A.        Corcept is commercializing an oral immediate release solid dosage
form, Corlux®
C-1073 (Mifepristone). Corcept has proprietary rights for the therapeutic use of
mifepristone and other GR-II antagonists for the treatment of psychiatric and
neurological disorders.

B.        PharmaForm is engaged in the business of, and has facilities for,
developing, testing and producing drug dosage forms.

C.        Corcept desires to engage PharmaForm and PharmaForm desires to be
engaged to develop, manufacture for clinical studies, and FDA filing purposes,
an immediate release solid dosage form containing mifepristone (“MIFEPRISTONE”)
suitable for oral administration pursuant to a Development Program as
hereinafter defined.

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and
considerations set forth herein, the parties hereto agree as follows:

ARTICLE 1

DEFINITIONS

The following terms shall have the meanings set forth in this Article 1.

1.1        “Confidential Information” shall mean and include this Agreement and
any and all information, including but not limited to, clinical, analytical
and/or scientific data, reports, processes, procedures, methods, formulations,
Inventions, and/or trade secrets relating to Products developed pursuant to this
Agreement and any other non-public information disclosed by a party pursuant to
this Agreement of any kind, nature or description concerning any matters
affecting or relating to the business of PharmaForm or Corcept.

1.2        “Development Program” shall collectively refer to the activities to
be conducted by Corcept and PharmaForm with respect to developing one or more
products containing MIFEPRISTONE, as reflected by and enumerated in the R&D Plan
as set forth in Article 2.

 

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1.3        “R&D Plan” shall collectively refer to the plan(s) and/or proposals
describing the scope(s), task(s) and goal(s) of the Development Program, which
shall be attached as Exhibits to and made part of this Agreement, as such
plan(s) or proposal(s) may from time to time be added, amended or modified by
written agreement of the Parties.

1.4        “Know-How” shall mean all present and future technical information
and practical experience which relates to any Product and shall include, without
limitation, all biological, chemical, pharmacological, toxicological, clinical,
assay, control, and manufacturing data and any other information relating to any
Product and useful for the development and commercialization of any Product.

1.5        “Invention(s)” shall mean any and all inventions or improvements,
discoveries, know-how, trade secrets, processes, compositions, machines or
manufactures or other technology (whether patentable or not) conceived or
reduced to practice during the term of this Agreement relating to any Product
including any compositions or formulations or any methods or processes of making
or using any Product.

1.6        “Product(s)” shall mean any and all pharmaceutical compositions,
formulations and dosing units containing MIFEPRISTONE that are developed under
this Agreement.

ARTICLE 2

DEVELOPMENT

2.1        Development Program.    Corcept and PharmaForm shall pursue a
Development Program as described in the R&D Plan attached as Exhibits, which set
forth the agreed tasks and goals of the Development Program. PharmaForm agrees
to perform the tasks assigned to it in the R&D Plan and to use its best efforts
to accomplish the agreed goals, with Corcept’s support and assistance (to the
extent provided in Exhibits). However, nothing therein shall bind PharmaForm to
any guarantees of success at any development stage nor shall the failure to
achieve the goals of the Development Program result in liability to PharmaForm
unless otherwise provided in this Agreement.

2.2        Technology Transfer.    To accomplish the goal of successful
formulation and development of Products, Corcept shall use commercially
reasonable efforts to transfer to PharmaForm reasonable amount of Product drug
substance, analytical methods for drug substance and cleaning methods for drug
substance as Corcept deems to be necessary, and such information shall be deemed
Corcept’s Confidential Information under Article 6. PharmaForm shall disclose to
Corcept all Inventions made and all Know-How generated under the Development
Program or relating to Products, promptly and on a regular basis, or as
requested by Corcept.

2.3        Regulatory Filings and Meetings.    PharmaForm agrees to use its best
efforts to provide information for regulatory filings and meetings at the
request of Corcept. Any such

 

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filings shall become properties of Corcept and shall be deemed Corcept’s
Confidential Information under Article 6.

2.4        Project Management and Schedules.    A formalized Product development
timeline will be prepared and periodically updated by Corcept based on input
from PharmaForm. The project timeline will serve as a project management tool
that will contribute to the effectiveness of the collaboration, and will
facilitate planning and management of the Development Program. The parties agree
to use commercially reasonable efforts to meet the timeline. PharmaForm agrees
to make every effort to expedite procurement and delivery of materials required
to perform the development work, but if the availability of materials necessary
to perform this development work is beyond the control of PharmaForm, then
PharmaForm makes no guarantees regarding availability of materials. If
PharmaForm becomes aware of a delay that may impact the timeline it will
immediately and fully communicate information concerning such delay to Corcept.
PharmaForm shall provide Corcept with written reports of its progress in
conducting the Development Program together with any data that have been
generated under the Development Program on a monthly basis, and such reports and
data shall be the property of Corcept and shall be deemed Corcept’s Confidential
Information under Article 6.

2.5        Non-Exclusive.    The parties agree and acknowledge that PharmaForm
is in the business of providing contract research and development services to
the pharmaceutical industry. Accordingly, PharmaForm shall be free to undertake
the provision of services to any third party and/or conduct research and
development on its own behalf so long as it does not otherwise breach the
confidentiality and intellectual property provisions of this Agreement;
provided, however, that during the term of this Agreement and during the two
year period following its expiration, without the consent of Corcept PharmaForm
shall not provide contract research and development services relating to any
product or product candidate (i) containing MIFEPRISTONE and (ii) with an
intended use or application in the field of neuropsychiatric disorders.

2.6        Commercial Supply Agreement.    The parties agree to negotiate in
good faith a commercial supply agreement for the manufacturing, packaging and
testing of Product for commercial sale and distribution, and shall use their
reasonable efforts to enter into such a contract on or before the submission of
an NDA for CORLUX by Corcept.

ARTICLE 3

INTELLECTUAL PROPERTY

3.1        Objective.    The two-fold intellectual property objective is to
establish a strong patent position for the Products that maximize the commercial
opportunity for the Product(s) while respecting valid third party patents.
PharmaForm and Corcept agree to use commercially reasonable efforts to develop
patentable Product(s). However, nothing herein is, or shall be construed to be,
a guarantee by PharmaForm that any Inventions will result from this Agreement.
To the extent any Inventions (whether or not patentable) result from the
Development Program under this Agreement, Corcept shall be the sole owner and
controller of all Inventions and any

 

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intellectual property rights arising out of this Agreement. PharmaForm agrees to
provide technical assistance as reasonably requested by Corcept’s patent counsel
regarding the determination of the freedom to operate in the field of drug
compositions, dosage forms, formulations, and delivery systems as they relate to
the subject matter of the Development Program. However, it is Corcept’s sole
responsibility to make the determinations in regard to both the freedom to
operate and decisions to pursue patent protection of Inventions developed
pursuant to the Development Program. Corcept is thus solely responsible for
decisions associated with preparing and filing patent applications and
prosecuting such applications. Corcept shall have sole responsibility for
maintaining any patent protection acquired and maintaining any actions against
infringing third parties of such intellectual property. PharmaForm shall use its
reasonable efforts to avoid potential infringement of third party intellectual
property in its performance under this Agreement, and to avoid the unauthorized
incorporation of any technology or matter that is claimed or covered by or under
any third party patents or other intellectual property rights. Subject to the
foregoing, PharmaForm neither guarantees nor assumes any legal liability in the
event that: (a) a court of law finds that Corcept’s drug compositions, dosage
forms, formulations, and delivery systems infringe the patents of others; or
(b) patents issued as a result of work performed in this Agreement are legally
challenged by a third party.

3.2        Additional Services.    As requested by Corcept, PharmaForm agrees to
provide the following services:

    (a)        Collaborating in setting and executing a patent strategy directed
to obtaining claims relating to MIFEPRISTONE and its forms or formulations,
including but not limited to claims to compositions of matter, pharmaceutical
compositions, formulations, process methodology, dosage forms performance, and
methods of treatment.

    (b)        Participating in interpretation of published patents and patent
applications to facilitate formulation development, assisting Corcept’s patent
counsel in setting a legal strategy by providing technical assistance, aiding in
the preparation of patent application(s), disclosing inventions developed
pursuant to the Development Program, assisting in inventorship determinations,
assisting in obtaining inventor signatures required for patent filing and patent
prosecution, and seeking reasonable assistance from the inventors for patent
filing and patent prosecution.

    (c)        Upon reasonable notice, participating in meetings with
Governmental Patent office(s) as may be necessary in the U.S. and abroad to
facilitate the issuance or defense of patents disclosing inventions resulting
from the Development Program.

3.3        Know-How.    All Know-How and intellectual property of Corcept
received by PharmaForm is Confidential Information of Corcept and is the sole
and exclusive property of Corcept. All Inventions and Know-How and other data
identified, discovered, developed, learned or applied in developing Product(s)
or otherwise in performance of services in accordance with this Agreement, shall
be and is deemed assigned to Corcept and is the

 

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Confidential Information of Corcept, and is the sole and exclusive property of
Corcept. All Know-How and intellectual property of PharmaForm received by
Corcept related to PharmaForm’s business and not arising from PharmaForm’s
services with regard to Product(s) hereunder is Confidential Information of
PharmaForm and is the sole and exclusive property of PharmaForm.

3.4        Intellectual Property Ownership.    The parties agree that Corcept is
and shall be the sole owner and controller of any intellectual property rights,
including all rights to Inventions, arising out of this Agreement. PharmaForm
shall and hereby does assign all rights, title and interest in any Inventions
arising out of this Agreement to Corcept. Notwithstanding the foregoing, Corcept
acknowledges and agrees that PharmaForm retains all right, title and license in
PharmaForm’s technology, knowledge, formulas, software, models, development
tools and routines, as well as derivatives and modifications thereof that exist
on or prior to the Effective Date (the “Developer Stock”), and that Corcept
shall have no rights in and to the Developer Stock incorporated into the
Product. Without the prior written consent of Corcept, PharmaForm shall not
incorporate any Developer Stock into the Products. The parties agree that:

    (a)        Corcept shall pay to PharmaForm the amounts for applications and
patents specified in Section 4.2;

    (b)        Corcept shall be responsible for payment of all fees and costs,
including without limitation attorneys’ fees, relating to the filing and
prosecution of each patent application hereunder;

    (c)        Each patent application and patent is assigned to Corcept;

    (d)        Corcept shall pay no royalty to PharmaForm or other inventors;

    (e)        Corcept shall pay no amount to PharmaForm for filing of foreign
patent applications or issuance of foreign patents;

    (f)        Fees as specified in Section 4.2 are due for each application or
patent with at least one PharmaForm inventor, even if Corcept co-inventors are
listed on the application or patent; and

    (g)        Neither party guarantees that a patent or patent application will
be filed, issued or maintained.

ARTICLE 4

PAYMENTS

4.1        Development Payment Schedule and Related Costs.    The parties hereby
agree to the following development payment schedule:

 

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    (a)        Development Payments.    Corcept agrees to pay PharmaForm
according to the payment schedule set forth in individual proposals for specific
development tasks outlined in Exhibits and additional tasks, as defined in such
proposals. Corcept agrees that any amount not paid within 30 days of notice is
overdue and will accrue interest at the lesser of [ *** ] per month or the
maximum rate allowed by law. In addition, without waiving all other rights or
remedies under law, PharmaForm may refuse to continue work under this Agreement,
terminate this Agreement under Section 8 of this Agreement and/or seek
collection from Corcept, including reasonable attorneys’ fees and costs of
court. Changes to this payment schedule are to be submitted in writing (i.e.,
change order) for prior written approval by Corcept.

    (b)        Clinical Supplies.    If requested by Corcept, production and
testing of clinical supplies will be provided under separate proposals and
attached as Exhibits. The acquisition of specific items required for the
manufacture of the clinical supplies, such as analytical columns, analytical
reference standards, drug substance, specialty excipients tablet tooling, and
packaging supplies, will be addressed in a separate proposals and attached as
Exhibits.

    (c)        Travel.    The cost of travel by PharmaForm representatives as
requested by Corcept under this Agreement is not included in this budget and
will require preapproval by Corcept and will be invoiced to Corcept in
accordance with PharmaForm’s standard travel billing policies.

4.2        Intellectual Property Payment Schedule.    In consideration of the
assignment of all intellectual property as described in Article 3 and in
addition to the amounts paid pursuant to Section 4.1, Corcept agrees to pay
PharmaForm the following amounts, but subject to the maximum set forth below:

    U.S. Patent Applications or U.S. Patents. Corcept agrees to pay PharmaForm
for each U.S. patent application filed, and each U.S. patent issued that claims
any Invention developed pursuant to the Development Program where a PharmaForm
employee is listed as an inventor or co-inventor according to the following fee
schedule:

 

Provisional U.S. Patent Application Filed

  

[ *** ]

U.S. Patent Issued

  

[ *** ]

Corcept agrees to pay PharmaForm an hourly rate of [ *** ]for work related to
preparation and prosecution of any patent applications or patents described in
Section 3.2.

 

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[ *** ]

Certain information on this page has been redacted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

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ARTICLE 5

PUBLICATION; PROHIBITION ON PUBLIC DISCLOSURE OF AGREEMENT

Corcept acknowledges that PharmaForm may have an interest in publishing certain
results of the Development Program, but PharmaForm recognizes that Corcept’s
interest in obtaining valid patent protection and protecting Corcept’s business
interests takes precedence over any such publication interest. Consequently,
PharmaForm agrees that it shall not publish or disclose any Inventions or
Know-how or data resulting from the Development Program or any other
Confidential Information of Corcept without the prior written consent of
Corcept.

Corcept acknowledges and agrees that due to the nature of mifepristone and
certain applications for which it was designed, PharmaForm has an interest in
prohibiting and limiting public disclosure of the terms and existence of this
Agreement and the relationship between Corcept and PharmaForm evidenced by this
Agreement. Accordingly, unless agreed upon in writing between PharmaForm and
Corcept, neither party shall discuss with third parties or originate any
publicity, news release or other public or private announcement, written or
oral, whether to the public press, stockholders or otherwise, regarding any
matters relating to the existence, content or terms of this Agreement, or any
amendment hereto, or the performance by either of the parties hereunder, except
for such announcement as in the opinion of legal counsel to the party making
such announcement is required under applicable law or stock exchange
regulations, in which event such party shall give the other party an
opportunity, reasonable under the circumstances, to review the form and content
of the announcement before such legally required disclosure is made. Subject to
confidentiality obligations set forth in this Agreement, either party may
discuss the terms of the Agreement with directors, officers, shareholders, legal
advisors, consultants, and financial investors.

ARTICLE 6

CONFIDENTIALITY

6.1        Nondisclosure Obligations and Exceptions.    All Confidential
Information received by one party from the other party or developed pursuant to
this Agreement is to be considered highly confidential. The receiving party
shall not use, except as provided for under this Agreement, or disclose to
others (except to those of its directors, officers, employees, consultants or
agents who require the information for purposes of carrying out the Agreement
and who are bound by a nondisclosure agreement not less restrictive than the
provisions in this Agreement) any such Confidential Information received from or
developed by the other without the express prior written consent of the other
party; provided, however, that the forgoing restrictions on disclosure and use
shall not apply to any specific Confidential Information of a party that the
receiving party can demonstrate with competent evidence:

 

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    (a)        was already known to the receiving party at the time of
disclosure without obligation to keep it confidential, as demonstrated by
written documentation;

    (b)        is generally available at the time of disclosure to the public,
or subsequently becomes generally available to the public other than by an act
or omission on the part of the receiving party charged with the obligations;

    (c)        subsequent to the disclosure is acquired from or made available
by a third party having the lawful right to disclose such information; or

    (d)        is developed by the receiving party without use of or reference
to the disclosing party’s confidential information.

For purposes of this Article 6, PharmaForm shall be deemed to be the “receiving
party” for any and all Confidential Information of Corcept that is initially
developed by PharmaForm pursuant to this Agreement and assigned to Corcept as
provided in Sections 3.1, 3.3 and/or 3.4.

6.2        Permitted Disclosures.    Notwithstanding the foregoing limits on
disclosure of Confidential Information, a receiving party shall be permitted to
disclose Confidential Information of the other party solely to the extent such
disclosure:

    (a)        is legally compelled to be disclosed pursuant to government
regulation, a subpoena, court order or administrative order or other legal
process; provided, however, that such party shall have first provided prompt
written notice to the other party of such subpoena, court order or
administrative order or other legal process so that such party may raise any
objections on its behalf and on behalf of the other party, which rights are
expressly reserved, seek a protective order or other appropriate remedy, and/or
otherwise agree to disclose for purposes of complying with such subpoena, court
order or administrative order or other legal process; and further provided that
should disclosure be required, such party shall exercise its commercially
reasonable efforts, at the expense of the disclosing party, to ensure that
confidential treatment be accorded such information;

    (b)        is required by law or regulation in connection with seeking
approvals, registrations, licenses, authorizations, visas, or permits required
by any governmental authority or agency in any country in order to import, offer
for sale, sell, market, manufacture, have made or use the Product(s) developed
pursuant to this;

    (c)        to a treating physician or health professional in the event that
a medical emergency associated with the handling or exposure to a Product
developed pursuant to this Development Agreement by a PharmaForm employee or
authorized representative solely to the extent that the physician or health
professional determines that a medical need exists for Confidential Information
in order to administer appropriate emergency or first-aid treatment; provided,
that Corcept shall promptly be notified of any disclosure required under this
Section 6.2(c) and the requesting physician or health professional

 

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shall immediately be referred to the appropriate contact person or
representative of Corcept; or

    (d)        if the disclosing party waives the right to restrict disclosure
under this Article 6.

6.3        Term of Confidentiality.    The restrictions on disclosure and use of
Confidential Information shall remain in force until [ *** ], the date of the
expiration confidentiality obligations set forth in the Mutual Confidentiality
and Non-Disclosure Agreement dated [ *** ] by and between PharmaForm and
Corcept. In the event of breach or threatened breach of the provisions of this
Section, either party shall be entitled to an injunction restraining the other
party from disclosing, in whole or in part, such Confidential Information.
Nothing herein shall be construed as prohibiting a party from pursuing any other
remedies available to it for such breach or threatened breach, including
recovery of damages from the other party.

ARTICLE 7

INDEMNIFICATION

7.1        Warranties.

    (a)        PharmaForm represents and warrants that: (i) PharmaForm has the
legal authority and right to enter into this Agreement; (ii) it has no
obligation to any other party which is in conflict with its obligations under
this Agreement; (iii) all activities hereunder will be completed in a timely
fashion, will conform to consistently high standards of workmanship and the
specifications reasonably requested by Corcept, and will be conducted in
compliance with all applicable laws, rules, regulations, guidelines and
standards and; (iv) all employees of PharmaForm have and will continue to have
the knowledge, experience, and skill to provide, and will provide, the services
hereunder and have executed an invention assignment agreement assigning all
Inventions related to this Agreement to PharmaForm, (v) all Product shall have
been manufactured and shipped in conformance with the specifications provided by
Corcept and will have been manufactured in accordance with current Good
Manufacturing Practices, (vi) Product will not be adulterated or misbranded
under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321 et seq., as
amended (“FFDCA”), or under any other applicable laws, rules, regulations or
requirements, and (vii) it will have obtained and maintained such approvals as
may be required under applicable laws, rules, regulations and requirements to
operate its manufacturing facility for the purposes contemplated by this
Agreement.

    (b)        Corcept represents and warrants that: (i) it has the legal
authority and right to enter into this Agreement; (ii) it has no obligation to
any other party which is in conflict with its obligations under this Agreement;
and (iii) it will conduct all activities under this Agreement in compliance in
all material respects with all applicable local, state and federal laws.

    (c)        EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
EXPRESS OR IMPLIED WARRANTIES HEREUNDER AND DISCLAIMS

 

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[ *** ]

Certain information on this page has been redacted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

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ALL WARRANTIES EXCEPT THOSE SET FORTH HEREIN, INCLUDING, WITHOUT LIMITATION,
IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

7.2        Indemnification by Corcept.    Corcept agrees to indemnify and hold
PharmaForm and each of its affiliates and representatives harmless from any and
all liability, loss, or damage PharmaForm might suffer as a result of claims,
demands, costs or judgments (including reasonable attorneys’ fees and costs of
court) against it arising out of this Agreement, including, without limitation,
any and all claims to the extent arising out of (a) any use of Product by
Corcept or third parties or the formulation of Product by PharmaForm in
accordance with the terms of this Agreement (and any amendments, addendums or
exhibits to this Agreement), (b) the manufacture, design, handling, use, sale,
offer for sale, distribution or other exploitation by Corcept or its licensees
of any Product or (c) patent infringement that may be brought against PharmaForm
related to such formulation, use or exploitation of the Product as a result of
intellectual property not provided by PharmaForm; provided, however, that this
indemnity will not cover any claims, demands, costs or judgments brought against
PharmaForm that are or are alleged to arise solely from the negligence, bad
faith, or misconduct of PharmaForm; a material breach of any applicable federal,
state or local law by PharmaForm; a material breach of this Agreement by
PharmaForm; or an act of alleged infringement of third party intellectual
property based on PharmaForm’s activities under this Agreement or unauthorized
incorporation of any technology, matter or intellectual property that is covered
under any third party intellectual property.

7.3        Indemnification by PharmaForm.    PharmaForm agrees to indemnify and
hold Corcept and each of its affiliates and representatives harmless from any
and all liability, loss or damage Corcept might suffer as a result of claims,
demands, costs or judgments (including reasonable attorneys’ fees and costs of
court) to the extent arising out of the (a) the negligence, bad faith or
misconduct on the part of PharmaForm, (b) a material breach of any applicable
federal, state or local law by PharmaForm, (c) a material breach of this
Agreement by PharmaForm, or (d) an act of alleged infringement of third party
intellectual property based on PharmaForm’s activities under this Agreement or
unauthorized incorporation of any technology, matter or intellectual property
that is covered under any third party intellectual property, other than
infringement based on intellectual property provided by Corcept.

7.4        Duty to Indemnify.    Each party’s agreement to indemnify and hold
the other harmless is conditioned on the indemnified party: (a) providing
written notice to the indemnifying party of any claim, demand or action arising
out of the Indemnified activities as soon as practicable but at least within 15
days after the indemnified party receives written notice of such claim, demand
or action, (b) permitting the indemnifying party to assume full responsibility
to investigate, prepare for and defend against any such claim, demand, or
action, (c) assisting the indemnifying party at the indemnifying party’s
reasonable expense, in the investigation of, preparation for and defense of any
such claim, demand or action, and (d) not compromising or settling such claim or
demand without the indemnifying party’s prior written consent.

 

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7.5        General Regulatory Compliance.    Each party, at its own expense,
will comply in all material respects with all applicable laws, orders and
regulations of any governmental authority with jurisdiction over its activities
in connection with this Agreement. Each party will furnish to the other party
any information required to enable the other party to comply in all material
respects with applicable laws and regulations related to the Products.

7.6        Limitation of Liability.    EXCEPT WITH RESPECT TO LOSSES PAYABLE IN
RESPECT OF INDEMNIFICATION OBLIGATIONS HEREUNDER, OR CAUSED BY A BREACH OF
CONFIDENTIALITY OR INTELLECTUAL PROPERTY OBLIGATIONS HEREUNDER OR BY THE GROSS
NEGLIGENCE, WILLFUL MISCONDUCT, FRAUD OR INTENTIONAL OR NEGLIGENT
MISREPRESENTATION OF A PARTY, A PARTY HEREUNDER SHALL NOT BE LIABLE TO THE OTHER
PARTY FOR (I) ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES
WHATSOEVER, INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, EVEN IF SUCH PARTY HAS
BEEN ADVISED, KNEW OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY THEREOF OR (II)
ANY AMOUNT GREATER THAN [ *** ] THE AGGREGATE OF ALL PAYMENTS PAYABLE TO
PHARMAFORM BY CORCEPT UNDER THIS AGREEMENT.

ARTICLE 8

TERM AND TERMINATION

8.1        Term.    The term of this Agreement (“Term”) shall commence upon the
Effective Date and expire upon the completion of the Development Program, unless
terminated earlier as provided in Section 8.2 or 8.3 below.

8.2        Termination for Cause.    Either party may terminate this Agreement,
at its option, upon the occurrence of any of the following:

    (a)        Voluntary Liquidation Events.    The other party shall (i) seek
the liquidation, reorganization, dissolution or winding up of itself or the
composition or readjustment of all or substantially all of its debts, (ii) apply
for or consent to the appointment of, or the taking of possession by, a
receiver, custodian, trustee or liquidator of itself or of all or any
substantial portion of its assets, (iii) make a general assignment for the
benefit of its creditors, (iv) commence a voluntary case under applicable
bankruptcy, insolvency, reorganization, winding-up or composition or
readjustment of debts or (v) adopt any resolution of its board of directors or
shareholders for the purpose of effecting any of the foregoing.

    (b)        Involuntary Liquidation Events.    A proceeding or case shall be
commenced without the application or consent of the other party and such
proceeding or case shall continue undismissed, or an order, judgment or decree
approving or ordering any of the following shall be entered and continue
unstayed in effect, for a period of 90 days from and after the date service of
process is effected upon the other party, seeking (a) its liquidation,
reorganization, dissolution or winding up, or the composition or

 

11400 Burnet Road

Building 4, Suite 4010

Austin, Texas 78758

     

Ph (512) 834-0449

Fax (512) 834-2105

www.pharmaform.com

           

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[ *** ]

Certain information on this page has been redacted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.

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readjustment of all or substantially all of its debts, (b) the appointment of a
trustee, receiver, custodian, liquidator or the like of itself or of all or
substantially all of its assets or (c) similar relief under any law relating to
bankruptcy, insolvency, reorganization, winding up or readjustment of debts.

    (c)        Material Breach.    Upon or after the breach of any material
provision of this Agreement, if the breaching party has not cured such breach
within 45 days after written notice thereof from the other party.

8.3        Termination.    Corcept shall have the right to terminate this
Agreement upon 180 days written notice to PharmaForm. PharmaForm shall have the
right to terminate this Agreement upon 180 days written notice to Corcept;
provided, however, if PharmaForm reasonably determines that continuing to
perform its obligations under this Agreement will result in a material adverse
effect on PharmaForm’s ongoing business, operations or personnel as a result of
negative or adverse publicity or responses from other clients or potential
clients of PharmaForm, PharmaForm and Corcept shall use commercially reasonable
efforts to expedite the transfer of all manufacturing operations and obligations
away from PharmaFrom, after which point PharmaForm shall have the right to
terminate this Agreement.

8.4        Effect of Termination.    Termination of this Agreement shall not
relieve the parties of any obligation, including the payment of money, accruing
prior to such expiration or termination. Sections 2.4 and 3.3 and the provisions
of Articles 4, 6, 7 and 9 shall survive the expiration or termination of this
Agreement.

ARTICLE 9

MISCELLANEOUS

9.1        Notice.    Any notice given under this Agreement must be in writing
and will be effective when delivered to the other party at the address set forth
for that party below. Notice addresses may only be changed in writing by the
parties by following the notice provisions of this Section 9.1.

Formulation Technologies, LLC

d/b/a/ PharmaForm

11400 Burnet Road

Suite 4010

Austin, Texas 78758

Attn: John Koleng, Ph.D.

Corcept Therapeutics Incorporated

149 Commonwealth Drive

Menlo Park, California 94025

Attn: Robert L. Roe, M.D.

 

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Building 4, Suite 4010

Austin, Texas 78758

     

Ph (512) 834-0449

Fax (512) 834-2105

www.pharmaform.com

           

13

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9.2        Entire Agreement.    This Agreement contains the entire understanding
of the parties with respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, heretofore made are
expressly superseded by this Agreement. This Agreement may be amended, or any
term hereof modified, only by a written instrument duly executed by both parties
hereto. No prior drafts of this Agreement may be used in the construction or
interpretation of this Agreement.

9.3        Waiver.    The waiver by either party hereto of any right hereunder
or the failure to perform or of a breach by the other party shall not be deemed
a waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.

9.4        Headings.    The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.

9.5        Drafting.    This Agreement was, and shall be deemed for all purposes
to have been, drafted by both parties.

9.6        Governing Law.    This Agreement shall be governed by and construed
in accordance with the laws of the State of Delaware, without regard to the
conflicts of laws principles thereof.

9.7        Assignment.    This Agreement may not be assigned or otherwise
transferred, nor, except as expressly provided hereunder, may any right or
obligations hereunder be assigned or transferred by either party without the
prior written consent of the other party. Notwithstanding the foregoing, this
Agreement may be assigned or transferred by a party without such prior consent
to any successor entity by merger, sale, transfer, or consolidation or the
transferee of all or substantially all of the assets of the business unit to
which this Agreement relates. Any permitted assignee shall assume all
obligations of its assignor under this Agreement.

9.8        Force Majeure.    Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement (except for the failure to pay money) when such failure or delay is
caused by or results from causes beyond the reasonable control of the affected
party, including, but not limited to, fire, floods, embargoes, war, acts of war
(whether war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority or the other party. The delayed
party’s time for performance will be excused for the duration of the force
majeure, but if the force majeure events lasts longer than 60 days, the other
party may immediately terminate this Agreement by giving written notice to the
delayed party.

9.9        Dispute Resolution.    Except as otherwise specifically provided
herein, any disputes or disagreements arising under the Agreement will be
referred to the chief executive officers of PharmaForm and Corcept for good
faith discussions, for a period not to exceed 60

 

11400 Burnet Road

Building 4, Suite 4010

Austin, Texas 78758

     

Ph (512) 834-0449

Fax (512) 834-2105

www.pharmaform.com

           

14

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days. During such 60 days, both parties may in good faith explore resolution of
the dispute using alternative dispute resolution techniques before pursuing
other remedies. If such dispute is not resolved by the end of such 60-day
period, the parties shall be free to pursue any legal or equitable remedy
available to them.

9.10        Independent Contractors.    Corcept and PharmaForm each acknowledge
that they shall be independent contractors and that the relationship between the
two parties shall not constitute a partnership, joint venture or agency. Neither
Corcept nor PharmaForm shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other party, without the prior consent of the other party to
do so.

9.11        Severability.    Should one or more provisions of this Agreement be
or become invalid, the parties hereto shall substitute, by mutual consent, valid
provisions for such invalid provisions which valid provisions in their economic
effect are sufficiently similar to the invalid provisions that it can be
reasonably assumed that the parties would have entered into this Agreement with
such provisions. In case such provisions cannot be agreed upon, the invalidity
of one or several provisions of this Agreement shall not affect the validity of
this Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
parties would not have entered into this Agreement without the invalid
provisions.

9.12        Product Labeling.    Corcept covenants and agrees to use its
commercially reasonable efforts to ensure that the product labeling and
packaging on any NDA Product batches or commercial Product batches does not
include any information relating to or identifying PharmaForm or associating
PharmaForm with the Product, including, without limitation, petitioning the FDA
to prevent the inclusion of any information identifying PharmaFrom on the
product labeling.

[Signature Page Follows]

 

11400 Burnet Road

Building 4, Suite 4010

Austin, Texas 78758

     

Ph (512) 834-0449

Fax (512) 834-2105

www.pharmaform.com

           

15

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FORMULATION TECHNOLOGIES L.L.C.

 

d/b/a PHARMAFORM

 

By:

 

        /s/ John Koleng, Ph.D.

      

        John Koleng, Ph.D.

      

        Chief Operating Officer

    

CORCEPT THERAPEUTICS

 

By:

 

        /s/         Robert L. Roe, M.D.

      

        Robert L. Roe, M.D.

      

        President

  

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Exhibit A – Development Program Tasks

 

 

•

 

Transfer tablet manufacturing process to PharmaForm; conduct process improvement
trials as required to achieve a reliable tablet production and coating process.

 

 

•

 

Develop and validate analytical methods required for testing the drug product
and drug substance. Specific methods required for testing will be based on
published regulatory guidance, specific regulatory feedback from the FDA and
other regulatory agencies and experience with the product.

 

 

•

 

Produce registration stability batches that will be used to establish the
stability of the product in the NDA or other regulatory submission. Conduct
stability studies (thermal and photostability) according to regulatory guidance
to generate stability data for regulatory submissions.

 

 

•

 

Perform product scale-up trials to scale the product from the registration
stability batch size to commercial size and establish criteria for process and
product validation.

 

 

•

 

Prepare a process and product validation protocol and produce validation batches
according to the protocol. Perform stability testing on the validation batches.

 

 

•

 

Conduct additional product development activities as needed to address specific
development issues as they arise.