Exhibit 10.1

MANUFACTURING AND SUPPLY AGREEMENT

This Manufacturing and Supply Agreement (the “Agreement”) effective as of
March 21, 2012 (the “Effective Date”) is entered into by and between Corcept
Therapeutics Incorporated, a Delaware corporation located at 149 Commonwealth
Drive, Menlo Park, CA 94025 (“Corcept”) and Formulation Technologies, LLC D/B/A
PharmaForm, LLC a Texas Limited Liability corporation located at 11501 Domain
Drive, Suite 130, Austin, TX 78758 (“PharmaForm”). Corcept and PharmaForm are
sometimes referred to individually as a “Party” and collectively as the
“Parties”.

RECITALS

Whereas:

 

I. Corcept and PharmaForm have entered into a Development Agreement
(“Development Agreement”) dated December 14, 2006 regarding an immediate release
dosage form of Mifepristone;

 

II. Pursuant to, and in connection with, the Development Agreement, the Parties
have agreed that PharmaForm shall manufacture Product (as defined below) for
Corcept for commercial pharmaceutical purposes, as set forth herein.

Now therefore, in consideration of the foregoing recitals, and the mutual
covenants and agreements contained herein, the Parties hereto, intending to be
legally bound, do hereby agree as follows:

 

1. Definitions

As used in this Agreement, the following terms shall have the meaning set forth
below.

 

  1.1 “Affiliate” means any corporation, firm, partnership or other entity,
which controls, is controlled by or is under common control with a Party. For
purposes of this definition, “control” shall mean the ownership of at least
fifty percent (50%) of the voting share capital of such entity or any other
comparable equity or ownership interest.

 

  1.2 “Analytical Method” means a documented procedure to perform an analytical
test related to the specifications of the Product.

 

  1.3 “Applicable Law” means all laws, ordinances, rules and regulations within
the United States applicable to the manufacturing, processing and supply of
Product, including, without limitation, (i) all applicable federal, state and
local laws and regulations of each the United States; (ii) the rules and
regulations of applicable Regulatory Authorities, and (iii) cGMP.

 

  1.4 “Batch” means a manufactured immediate release formulation tablets
containing the Compound that equals [***] tablets.

 

  1.5 “CMR” means Commercial Master Record. The Commercial Master Record is a
controlled document which is mutually approved by both PharmaForm and Corcept
and consists of the formulation of the Product, listing of the equipment
required to produce the Product, and explicit instructions for manufacturing the
Product. A controlled copy of the Commercial Master Record is used to document
the lot numbers and quantities of the components used in manufacturing a
specific lot of the Product and for documenting the execution of the process
steps required to produce the Product.

 

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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  1.6 “cGMP” means the then current Good Manufacturing Practice as defined in 21
CFR 210 and 211, the International Conference on Harmonization (“ICH”) guide Q7A
“ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,”
(“API”) as applied to the manufacture, testing, and quality control of APIs and
similar requirement of other Regulatory Authorities, as amended from time to
time.

 

  1.7 “Compound” means the API known as mifepristone as acquired and supplied to
PharmaForm by Corcept.

 

  1.8 “Confidential Information” means all such information furnished by the
Disclosing Party, its representatives or Affiliates to the Receiving Party, or
any of its respective representatives or Affiliates, whether furnished before,
on or after the Effective Date and furnished in any form, including but not
limited to written, verbal, visual, electronic or in any other media or manner
and includes, but is not limited to, patents, patent applications, inventions,
analyses, business or technical information, know-how, trade secrets,
copyrights, trademarks, trade names, designs, concepts, technical information,
manuals, and instructions.

 

  1.9 “Corcept Technology” means all foreign and domestic patents, patent
applications, patent rights, know-how, trade secrets, copyrights, technical
data, inventions (whether patentable or not), discoveries, designs,
specifications (including, but not limited to, Specifications), standard
operating procedures, plans, works of authorship, techniques, methods,
processes, test procedures, manufacturing instructions, cleaning procedures and
all other scientific or technical information or materials, which as of the
Effective Date, are owned or controlled by Corcept or an Affiliate and pertain
to the Product.

 

  1.10 “Disclosing Party” means the Party that has furnished Confidential
Information.

 

  1.11 “Facility” means a PharmaForm manufacturing establishment maintaining a
current FDA Establishment Registration and located at 11501 Domain Drive, Suite
130, Austin, TX 78758.

 

  1.12 “[***] Sub Lot” means the portion of the process for making the Compound
into a tablet which consists of [***]

 

  1.13 “Latent Defect” means a Nonconformity that was (i) not reasonably
discoverable within the period specified in 8.3 using the quality control
procedures outlined in the Specifications or the Quality Assurance Agreement;
(ii) are attributable to PharmaForm’s manufacture of the Product, and not to the
improper handling or storage of Product; and (iii) could not reasonably been
deemed to have occurred after delivery of Product to the carrier.

 

  1.14 “Nonconformity” means a characteristic, factor or circumstance related to
the Product which does not conform to the Specifications.

 

  1.15 “PharmaForm Technology” means all foreign and domestic patents, patent
applications, patent rights, know-how, trade secrets, copyrights, technical
data, inventions (whether patentable or not), discoveries, designs,
specifications, standard operating procedures, plans, works of authorship,
techniques, methods,

 

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

 

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  processes, test procedures, manufacturing instructions, cleaning procedures
and all other scientific or technical information or materials, which as of the
Effective Date, are owned or controlled by PharmaForm or an Affiliate and
pertain to the Product.

 

  1.16 “Price” shall mean the quantity of compensation for the manufacturing of
the Product, including [***]

 

  1.17 “Product” shall mean immediate release formulation tablets containing the
Compound that is manufactured for pharmaceutical commercial use under this
Agreement.

 

  1.18 “Production Scale” means one (1) Batch produced [***]

 

  1.19 “Quality Service Agreement” shall mean the specific quality parameters
for the manufacturing process and the Product as well as which party is
responsible for the execution of the parameters as agreed to by the Parties and
defined in Appendix V hereto.

 

  1.20 “Receiving Party” shall mean the Party that has received Confidential
Information.

 

  1.21 “Regulatory Authority” means any governmental regulatory authority within
a country of the Territory involved in regulating any aspect of the development,
manufacture, market approval, sale, distribution, packaging or use of drug
products, including, but not limited to, the Food and Drug Administration
(“FDA”), Health Canada, the Therapeutic Goods Administration and The European
Agency for the Evaluation of Medicinal Products.

 

  1.22 “Specifications” shall mean the specifications of the Product set by
Corcept and defined in Appendix I hereto.

 

  1.23 “Stability Testing” shall mean the storage of the Product in defined
packaging configurations, under controlled temperature and humidity conditions,
for the purpose and execution of periodic testing of the Product according to
any protocol approved by both Parties.

 

2. Manufacture and Supply

 

  2.1 From time to time during the course of this agreement and subject to the
terms and conditions set forth herein, PharmaForm shall manufacture Product for
Corcept.

 

  2.2 The responsibilities of the Parties concerning the quality of the Product
shall be set forth in the Quality Assurance Agreement.

 

  2.3 PharmaForm agrees to maintain FDA Establishment Registration and to
deliver to Corcept the Product per the Specifications.

 

  2.4 Corcept agrees to take delivery of the Product under the terms and
conditions set forth in this Agreement.

 

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

 

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3. Supply; Forecast; Orders

 

  3.1 Corcept will provide its management’s best quarterly estimates, on or
before [***]

 

  3.2 From time to time during the duration of this agreement, Corcept may
request the manufacture of Product by PharmaForm by submitting purchase orders.
All purchase orders are irrevocable and may only be modified by mutual written
agreement of the Parties. All requests for manufacturing of Product must be
made, at a minimum, [***] calendar days prior to the requested shipment date.
Each purchase order shall specify the quantity of Product ordered, requested
delivery date and address for delivery. Any different or additional terms shall
not be binding on PharmaForm unless expressly agreed in writing by PharmaForm.
In the event of a conflict between the terms of any such purchase order and this
Agreement, this Agreement shall control.

 

  3.3 Corcept agrees to supply or have supplied to PharmaForm sufficient
quantities of Compound to allow PharmaForm to manufacture Products ordered by
Corcept pursuant to Section 3.2. Corcept shall deliver such Compound to
PharmaForm at the Facility. Such Compound will remain the property of Corcept at
all times, and title to all Product shall vest in Corcept on its creation.
Corcept shall bear the risk of loss of both Compound and Product unless such
loss is caused by the willful misconduct or gross negligence of PharmaForm.

 

  3.4 PharmaForm shall, by the terms of each purchase order, ensure for the
timely manufacture and shipment of the requested quantity of Product to Corcept.
In the event that a Corcept purchase order should exceed the estimated
manufacturing volume forecasted by Corcept pursuant to Section 3.1 above,
PharmaForm shall supply the forecast amount, and shall use commercially
reasonable efforts to manufacture all requested Product in excess of the
forecast amount. In the event that PharmaForm does not have the ability, or does
not fulfill an order to manufacture in excess of Corcept’s most recent forecast,
PharmaForm assumes no financial or legal liability related to any impact to
Corcept’s ability to operate or resulting legal or financial liabilities
incurred by Corcept should Corcept be unable to deliver sufficient final
commercial product to the market in a timely manner.

 

  3.5 PharmaForm shall confirm all purchase orders in writing or via email
within three (3) days after receipt.

 

  3.6 In case of reduction of quantity to deliver and/or delay of delivery date
due to a Force Majeure as specified in Section 14, PharmaForm shall state the
reasons which led to the reduction of quantity or delay of supply past the given
delivery date. The Parties will reasonably cooperate to find a solution, which
conforms to the requirements of Corcept and the capability of PharmaForm to
ensure the supply of Product to Corcept.

 

  3.7 Corcept may from time-to-time request PharmaForm to conduct Stability
Testing for the Product. Corcept will submit purchase orders for Stability
Testing as needed to PharmaForm. The cost for Stability Testing shall be the
cost listed in Appendix III.

 

  3.8 Performance by PharmaForm. PharmaForm shall not delegate its
responsibilities under this Agreement to any third parties, including any
Affiliates of PharmaForm without the prior written permission of Corcept. In the
event Corcept agrees to such a delegation of PharmaForm’s responsibilities under
this Agreement, PharmaForm shall ensure such third party complies with the terms
and conditions of this Agreement.

 

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

 

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4. Price; Quantities

 

  4.1 The Price payable by Corcept to PharmaForm for the Product supplied
hereunder shall be the Price listed in Appendix II and as modified per
Section 4.2.

 

  4.2 After the [***] anniversary of this Agreement, the price charged by
PharmaForm to Corcept may be adjusted on an annual basis as set forth in this
Section 4.2. The first price adjustment shall be effective on [***]and
subsequent price adjustments shall be effective on each anniversary thereof,
provided that PharmaForm provide Corcept at least ninety (90) days written
notice of any such price adjustment. Any increase in Price contemplated under
this Article 4.2 shall not exceed: [***]

 

  4.3 Unless otherwise specified by Corcept, certain materials required for
manufacture and testing of Product identified in Appendix IV (“Corcept Starting
Materials”) will be purchased by PharmaForm after pre-approval by Corcept, from
mutually agreed vendors, tested and released according to agreed specifications,
and Corcept shall reimburse PharmaForm for PharmaForm’s out-of-pocket costs for
such Corcept Starting Materials. Any other materials required for manufacture
and testing of Product will be purchased by PharmaForm (“PharmaForm Starting
Materials”) from mutually agreed vendors, tested, and released according to the
Specifications.

 

5. Terms of Payment

 

  5.1 Payment for the cost for manufacturing will be made within thirty
(30) days after receipt of delivery of the Product and invoice.

 

  5.2 Prices are exclusive of any sales or value-added taxes, duties or other
taxes. Corcept shall pay all taxes incurred due to the sale or delivery of
Product hereunder, except for any taxes based on the income of PharmaForm.

 

  5.3 If Corcept fails to pay any invoice under this Agreement when due, and
does not cure such failure within fifteen (15) days after written notice
thereof, then PharmaForm may charge interest on the unpaid balance at a rate
equal to the lesser of [***] per month or the maximum rate permitted under
applicable law, and PharmaForm may require payment in advance of shipment of
Products until such time as payment of the outstanding balance is made in full.

 

6. Terms of Delivery

 

  6.1 PharmaForm shall deliver Product to the carrier selected by Corcept, and
Corcept shall bear all risk of delay, damage or loss of any manufactured Product
during transport and shall be responsible for any costs related to
transportation and/or insurance during transport of the Product. Corcept shall
instruct the delivery destination of the Product in each purchase order. For any
shipment of Product outside of the United States, Corcept shall be the exporter
of record and responsible for all costs, required documentation and legal
representations.

 

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

 

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7. Change Management

If during the course of this Agreement, a change in Specifications, Production
Scale or Analytical Methods is requested by Corcept (for example due to
regulatory agency request) the Parties will mutually evaluate the potential
effect of such change on the Product to any Analytical Methods and the CMR. The
changes must be agreed to by both Parties with a minimum of [***] days prior to
the shipment of Product with new Specifications with PharmaForm’s consent not
being unreasonably withheld. Prior to the manufacturing of Product under any
such changed Specification, Production Scale or Analytical Method, the Parties
agree to amend this agreement to address any additional costs to PharmaForm to
implement such changes, and any changes to the Price necessary to implement such
changes.

 

8. Specification, Quality Control, Warranty

 

  8.1 All Product delivered by PharmaForm shall be in conformance with the
Quality Assurance Agreement, the Specifications and any Applicable Laws.

 

  8.2 PharmaForm shall be responsible for release testing of each Batch of
Product. PharmaForm will provide a Certificate of Analysis (“CoA”) with each
batch or lot of Product. The CoA will include a Product batch or lot number, the
Specification and associated result of each analytical test performed on the
Product and other information required under the Applicable Laws.

 

  8.3 Corcept shall have [***] days from the receipt of Product to inspect the
Product and/or perform or have performed any or all of the quality control
procedures outlined in the relevant Specifications or the Quality Assurance
Agreement to determine if the Product meets the Specifications. If Corcept has
evidence to indicate that Product does not meet the Product Specifications, the
Quality Assurance Agreement or Applicable Law and therefore contains a
Nonconformity (such product being a “Defective Product”), Corcept shall promptly
notify PharmaForm in writing and PharmaForm shall retest retained samples of
such Product. Any Defective Product shall, at PharmaForm’s sole discretion and
expense, either (i) be returned to PharmaForm within a reasonable period of
time, or (ii) destroyed in accordance with Applicable Law. If the results of
such retesting confirm that such Defective Product does not meet Product
Specifications, the Quality Assurance Agreement or Applicable Law, and provided
Corcept can certify in writing that the Defective Product was at all times
during shipment and after receipt by Corcept, or its designated agent, handled
and stored in accordance with cGMP and the recommended storage conditions,
PharmaForm shall promptly [***]. The cost to Corcept for any Replacement Product
shall be as set forth in Section 4.1.

 

  8.4 In the case of Product with a Latent Defect, Corcept shall promptly, and
in no event more than [***] business days after discovery or notification of
such Latent Defect, notify PharmaForm of such Latent Defect. After the delivery
of the Product, PharmaForm shall have no responsibility for Product with Latent
Defects discovered after the expiration of the known shelf life of the Product
which has been established by stability studies and agreed by the applicable
regulatory agency. The replacement of Product with a Latent Defect and the cost
incurred with such replacement shall be as set forth in Section 8.3 of this
Agreement.

 

  8.5 Quality Assurance Agreement. Within thirty (30) days after the Effective
Date, the Parties shall execute a Quality Assurance Agreement in substantially
the form attached to this Agreement as Exhibit V. The Quality Assurance
Agreement

 

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

 

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  shall in no way determine liability or financial responsibility of the Parties
for the responsibilities set forth therein. In the event of a conflict between
the terms of this Agreement and the Quality Assurance Agreement in relation to
quality issues, the Quality Assurance Agreement shall control; in all other
cases, the terms and conditions of this Agreement shall control.

 

9. Technology Licenses; Intellectual Property Ownership.

 

  9.1 Licenses

Corcept hereby grants to PharmaForm a non-exclusive, royalty-free license to use
the Corcept Technology, without the right to sublicense, solely for the purpose
of performing its obligations under this Agreement and solely during the term of
this Agreement. On termination or expiration of the Agreement for any reason,
all such licenses granted by Corcept to PharmaForm shall be terminated.

 

  9.2 Intellectual Property Ownership

 

  (a) All Corcept Technology is and shall remain the sole property of Corcept.
PharmaForm shall use the Corcept Technology solely for the purposes of
performing under this Agreement.

 

  (b) This Agreement is for the manufacture of the Product in accordance with
previously developed processes and procedures. Any modifications to such
processes and procedures, and the ownership of any intellectual property rights
therein, would be covered under a separate written agreement between the
parties.

 

10. Records and Regulatory Matters.

 

  10.1 Batch Records and Data. If requested, PharmaForm shall at its expense
provide Corcept or its designee with one properly completed copy of the batch
records prepared for each batch of Product released by PharmaForm’s quality
control group. PharmaForm will provide additional copies at Corcept’s expense.

 

  10.2 Recordkeeping. PharmaForm shall maintain true and accurate books,
records, test and laboratory data, reports and all other information relating to
its performance under this Agreement, including all information required to be
maintained by all Applicable Laws and any Regulatory Authority. Such information
shall be maintained in forms, notebooks and records for a period of at [***]
years or longer if required by Applicable Laws.

 

  10.3 Audits.

 

  10.3.1 During the term of this Agreement, duly-authorized employees, agents
and representatives of Corcept shall be granted access to the Facility once per
calendar year as per the terms of the Quality Assurance Agreement for the
purpose of inspecting and verifying that PharmaForm is complying with Applicable
Laws, the Specifications and the Batch records. PharmaForm shall make all
records regarding its performance under this Agreement reasonably available for
inspection by Corcept at such audits, as well as any records relating to
performance of any third parties that are performing under this Agreement or
supplying materials or ingredients to be used in the performance of this
Agreement. Corcept

 

[***] Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
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  shall have the right to perform additional audits as mutually agreed, with
PharmaForm’s consent not being unreasonably withheld, solely to the extent
necessary to address specific quality problems with the Product, however such
problems are identified. Corcept shall also have the right to verify the
quantity of Corcept Starting Materials remaining, any Product on-site and any
materials owned by Corcept at PharmaForm. PharmaForm shall cooperate with the
auditors for a reasonable length of time. Furthermore, PharmaForm shall submit
to inspections by any Regulatory Authority as may be required by Applicable Law
or requested by such Regulatory Authority. In the event that deficiencies in
meeting with the requirements of this Agreement are discovered by Corcept or
such Regulatory Authority and reported to PharmaForm, PharmaForm shall respond
within a reasonable period of time to Corcept with a written plan for corrective
action, and shall execute such plan as mutually agreed or as required by
Applicable Law.

 

  10.3.2 During the term of this Agreement and not more than once in a twelve
month period, subsequent to [***] and during a year in which the Parties have
agreed to an increase in Price, PharmaForm agrees that Corcept shall have the
right, on at least [***] business days’ written notice, at Corcept’s own
expense, to have an independent, third party licensed CPA, reasonably acceptable
to PharmaForm, to audit PharmaForm’s books and records pertaining to the
acquisition of all raw materials, regulatory compliance costs, and allocated
labor directly associated with manufacturing and processing of Product in
conjunction to supply price adjustment under Section 4.2. Audits of this nature
will take place during regular business hours and last no longer than 10
business days.

 

  10.4 Inspection of Processing. Corcept’s representatives may elect to be
on-site for consultation during a regulatory inspection specifically related to
the Product. Direct interaction with Regulatory Authorities shall be the sole
responsibility of PharmaForm personnel. Corcept shall indemnify and hold
harmless PharmaForm for any action or activity of such representatives while on
PharmaForm’s premises, that causes any change or modification to Analytical
Methods or CMRs resulting in any deviation, NCE or investigation or that results
in any injury or damage to person or property, except to the extent arising from
PharmaForm’s negligence or breach of this Agreement.

 

  10.5 Governmental Inspections and Requests. PharmaForm shall promptly, within
[***] business days, advise Corcept in writing if an authorized agent of any
Regulatory Authority intends to visit the Facility. Such notification shall
occur in advance if PharmaForm is provided any advance notice. If PharmaForm is
not provided any advance notice, such notification shall occur as soon as
reasonably possible. PharmaForm shall furnish to Corcept a copy of any report
issued by such Regulatory Authority within [***] days of PharmaForm’s receipt of
such report in the event that such report relates to or may reasonably be deemed
to impact Corcept, the Compound, the Product or the manufacture or processing of
the Product. Further, upon receipt of a Regulatory Authority request to inspect
the Facilities or audit PharmaForm’s books and records with respect to the
Facility or the Product, PharmaForm shall promptly, within[***]business days,
provide written notification to Corcept, and shall provide Corcept with a copy
of any written document received from such Regulatory Authority as it relates to
the Product. PharmaForm will additionally notify Corcept in writing of any and
all

 

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

 

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  inspections of the Facility by any third party other than a Regulatory
Authority that could in any way be reasonably deemed to affect PharmaForm’s
ability to supply Product in a timely fashion.

 

  10.6 Recall. In the event PharmaForm believes a recall, field alert, Product
withdrawal or field correction may be necessary with respect to any Product
provided under this Agreement, PharmaForm shall as soon as is practicable and in
any event within [***], notify Corcept in writing of such belief and provide a
reasonable detailed description of the reasons for it. PharmaForm will not act
to initiate a recall, field alert, Product withdrawal or field correction
without the express prior written approval of Corcept, unless otherwise required
by Applicable Laws. In the event Corcept believes a recall, field alert, Product
withdrawal or field correction may be necessary with respect to a Product
provided under this Agreement, Corcept shall immediately notify PharmaForm in
writing and PharmaForm shall provide all necessary cooperation and assistance to
Corcept. Corcept shall bear the cost of, and shall reimburse PharmaForm for
expenses incurred in connection with, any recall, field alert, Product
withdrawal or field correction related to the Product unless such recall, field
alert, Product withdrawal or field correction is caused primarily by
PharmaForm’s breach of its obligations under this Agreement or Applicable Laws.
Failure to supply Product that complies with the terms of this Agreement, or its
negligence or willful misconduct, in which case, such cost shall be borne by
PharmaForm. For purposes hereof, such cost to PharmaForm shall be limited to
reasonable, actual and documented administrative costs incurred by Corcept for
such recall, withdrawal or correction, and replacement of the Defective Product
to be recalled, in accordance with Section 8.

 

  10.7 Quality Assurance Agreements. All records and regulatory matters shall be
compliant with the Quality Assurance Agreement and with 21 CFR and any other
Applicable Laws.

 

11. Indemnification

 

  11.1 Corcept shall defend, indemnify and hold harmless PharmaForm, its
affiliates and their respective directors, officers, employees, and agents, and
their respective successors and permitted assigns (the “PharmaForm
Indemnitees”), from and against any and all suits, claims, losses, demands,
liabilities, damages, costs and expenses (including reasonable attorneys’ fees)
in connection with any suit, demand or action by any third party (“Losses”)
arising out of or resulting from:

 

  (a) Corcept’s or its Affiliate’s, licensee’s or sublicensee’s use, sale,
testing or development of the Product;

 

  (b) a material breach by Corcept of any of its representations, warranties,
covenants, agreements or obligations under this Agreement; and

 

  (c) the negligence, recklessness or willful misconduct of Corcept in the
performance of its other obligations under this Agreement; provided, however
that the foregoing indemnity obligations of Corcept pursuant to this
Section 11.1 shall not apply to the extent of any Losses subject to an indemnity
obligation pursuant to Section 11.2 below.

 

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  11.2 PharmaForm shall defend, indemnify and hold harmless Corcept, its
affiliates and their respective directors, officers, employees, and agents and
their respective successors and permitted assigns (the “Corcept Indemnitees”),
from and against all any and all Losses arising out of or resulting from:

 

  (a) a material breach by PharmaForm of any of its representations, warranties,
covenants, agreement or obligations under this Agreement;

 

  (b) any actual or alleged infringement or violation of any patent, trade
secret, copyright, trademark or other proprietary rights directly related to
PharmaForm Technology; and

 

  (c) the negligence, recklessness or willful misconduct of PharmaForm in its
Service including the manufacture or processing of Product or in the performance
of any of its other obligations under this Agreement; provided, however, that
the foregoing indemnity obligations of PharmaForm pursuant to this Section 11.2
shall not apply to the extent of any Losses subject to an indemnity obligation
under 11.1 above.

 

  11.3 Each Party agrees to give the other Party: (a) prompt written notice of
any claims made for which one Party knows or reasonably should know the other
Party reasonably may be liable under the foregoing indemnification; and (b) the
opportunity to defend, negotiate, and settle such claims.

 

  11.4 Each Party shall provide the other Party with all information in its
possession, all authority and all assistance necessary (at the expense of the
other Party) to enable the other Party to carry on the defense of such suit;
provided, however that each Party reserves the right to retain its own counsel
to defend itself in such suit.

 

  11.5 Neither Corcept nor PharmaForm shall compromise or settle any claim or
liability without prior written consent of the indemnifying Party.

 

  11.6 OTHER THAN WITH RESPECT TO A BREACH OF CONFIDENTIALITY OR A PARTY’S GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY, INCLUDING ITS
AFFILIATES, BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, SPECIAL
OR CONSEQUENTIAL LOSSES OR DAMAGES OF THE OTHER PARTY, WHETHER BASED UPON
CONTRACT, NEGLIGENCE, OR OTHER THEORY OF LAW.

 

12. Term

This Agreement shall become effective on the Effective Date and shall continue
for an initial period of two (2) years. It shall be automatically extended for
additional one (1) year periods unless one Party gives six (6) months’ prior
written notice that it does not want such an extension.

 

13. Termination for Cause

 

  13.1 In the event that either Party should commit a breach of any of its
obligations under this Agreement, and shall have not cured such breach within
[***] days after receipt of written notice of breach from the other Party, then
such other Party shall have the right to terminate this Agreement immediately by
written notice.

 

[***] Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
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  13.2 In the event that either Party should become insolvent or make an
assignment for the benefit of creditors or proceedings in voluntary or
involuntary bankruptcy should be instituted against it or a receiver or trustee
of its property should be appointed, then the other Party shall have the right
to terminate this Agreement forthwith by written notice.

 

  13.3 In the event that PharmaForm is not able to manufacture the Product
according to the Specifications stated in Appendix I or for any reason should be
unable (including but not limited to cases of Force Majeure) to supply the
Product for a consecutive [***] month period or for a total of [***] months
non-consecutively in one calendar year (whether in the quantities ordered or at
all), Corcept shall have the right to terminate this Agreement forthwith by
written notice. The right to terminate is in addition to any other remedy
available at law or in equity.

 

  13.4 In the event that PharmaForm shall fail to promptly secure or renew any
license, registration, permit, authorization, or approval necessary for the
conduct of its business in the manner contemplated by this Agreement, or if any
such license, registration, permit, authorization, or approval is revoked or
suspended and not reinstated within [***] days or if reinstatement is not
possible within [***] days, diligent efforts are not being made by PharmaForm to
effect such reinstatement, then Corcept shall have the right to terminate this
Agreement immediately by written notice.

 

  13.5 On termination or expiration of this Agreement, PharmaForm shall take
reasonable measures to cease any ongoing production of Product and limit further
expenses associated with such ongoing production. Expiration or termination of
this Agreement shall be without prejudice to any rights or obligations that
accrued to the benefit of either party prior to such expiration or termination.
In the event of any termination or expiration, PharmaForm shall promptly return
(1) any remaining inventory of Compound or other materials received from Corcept
(including the Corcept Starting Materials), (2) all remaining inventories of
Product (subject to payment by Corcept of the applicable Price for such
Product), and (3) any other Product or material being stored for Corcept, to
Corcept at Corcept’s expense, but not including the PharmaForm Starting
Materials.

 

14. Force Majeure

If a Party is delayed in fulfilling any of the terms and conditions hereunder
due to acts of God, war, prohibitions on exports or imports, fires, floods,
strikes, sabotage, civil commotion or riots, earthquakes, or any other cause
beyond such Party’s reasonable control, time for such performance by such Party
shall be extended by the period of time equal to the liability to the other
Party, by reason of such delay in performance. Once the force majeure cause
ceases to exist, all terms and conditions of this Agreement will again prevail.
Notwithstanding the foregoing, if a Party fails, for a period of at least sixty
(60) days, to fulfill any of its obligations under this Agreement due to a force
majeure event, the other Party may terminate this Agreement pursuant to
Section 13.3.

 

15. Hardship

If, at any time during the term of this Agreement, there is a substantial change
in the economic, technological or market situation which will make the
performance of this Agreement unrealistic or exceedingly unfair by either Party,
aggrieved Party can request a meeting with the other Party to discuss the
situation, but there is no obligation to adjust the terms of this Agreement.

 

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

 

11

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16. Confidentiality

 

  16.1 Except as expressly allowed in this Agreement, the Receiving Party will
hold in confidence and not disclose any Confidential Information of the
Disclosing Party during the term of this Agreement and for a period of seven
(7) years thereafter. Except as expressly provided in this Agreement, the
Receiving Party agrees not to use the Confidential Information of the Disclosing
Party for any commercial purpose, except for the exercise of its rights or
performance of its obligations under this Agreement. Notwithstanding the
foregoing, the Receiving Party may disclose the Disclosing Party’s Confidential
Information to any of its Affiliates that (A) need to know such Confidential
Information for the purpose of performing under this Agreement, (B) are advised
of the contents of this Section 16, and (C) agree to be bound by the terms of
this Article.

 

  16.2 The Receiving Party shall not be obligated under this Section 16 with
respect to any information the Receiving Party can document:

 

  (a) is or has become publicly available through no fault of the Receiving
Party or its employees; or

 

  (b) is received from a third party lawfully in possession of such information
and lawfully empowered to disclose such information; or

 

  (c) was rightfully in the possession of the Receiving Party prior to its
disclosure by the Disclosing Party as evidenced by written records of the
Receiving Party; or

 

  (d) is independently developed by employees or consultants of the Receiving
Party without use of Confidential Information of the Disclosing Party as
evidenced by written records of the Receiving Party.

 

  16.3 Notwithstanding the foregoing, the Receiving Party may disclose
Confidential Information to the extent it is required to be disclosed to a
governmental agency in connection with seeking any governmental or regulatory
registration, approval or license, or pursuant to the lawful requirement or
request of a governmental agency, provided that reasonable measures are taken to
request confidential treatment thereof to the extent and for the time allowed
and to guard against further disclosure, and further provided, that reasonable
written notice is provided to the Disclosing Party, to enable the Disclosing
Party, to seek protection of the confidentiality of such Confidential
Information, with which the Receiving Party will assist in any reasonable way.

 

  16.4 Upon termination or expiration of this Agreement, the Receiving Party
shall cease all use of the Confidential Information of the Disclosing Party
(except as otherwise provided in this Agreement) and, upon request, promptly
return within [***] days all such Confidential Information, including any copies
thereof, or at the request of the disclosing Party, shall promptly destroy the
same and certify such destruction to the Disclosing Party; except for a single
copy thereof, which may be retained for the sole purpose of determining the
scope of the obligations incurred under this Agreement.

 

  16.5 Confidential Information also includes the existence of this Agreement
and its terms.

 

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

 

12

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17. Non-Assignability

This Agreement and the rights and obligations of the Parties under this
Agreement are assignable or transferable only with the prior written consent of
the other Party such consent not to be unreasonably withheld or delayed;
provided, however, that either Party may assign the rights and obligations to an
Affiliate, and further provided that either Party may assign this Agreement to
any party that acquires all or substantially all of such Party’s assets and
operations, whether by merger, sale of assets, or otherwise. Any assignments or
transfers in violation of this Section 17 shall be void. This Agreement shall be
binding on any successors or assignees authorized by this Section 17.

 

18. Severability

In the event that any provision (or portion thereof) of this Agreement conflicts
with Applicable Law or if any provision is held to be null, void or otherwise
ineffective or invalid by a court of competent jurisdiction, then (i) such
provision (or portion thereof as applicable) will be deemed to be restated to
reflect as nearly as possible the original intentions of the Parties in
accordance with applicable law, and (ii) the remaining terms, provisions,
covenants and restrictions of this Agreement will remain in full force and
effect

 

19. Waiver

No waiver of any provision of this Agreement or any right or obligation of a
Party shall be effective unless in writing and signed by the Parties. The
failure of either Party to enforce a right shall not constitute a waiver.

 

20. Entire Agreement and Notification

 

  20.1 The terms and conditions herein contained constitute the entire Agreement
between the Parties with respect to the subject matter hereof.

 

  20.2 No modification or amendment of this Agreement shall be binding upon
either Party hereto unless in writing and signed by duly authorized officers of
the Parties. Appendix I, Appendix II, Appendix III and Appendix IV of this
Agreement form an integral part of this Agreement.

 

21. Governing Law; Dispute Resolution

 

  21.1 Governing Law. This Agreement shall be deemed to have been executed and
entered into in the State of California, and this Agreement, and its formation,
operation and performance, shall be governed, construed, performed, and enforced
in accordance with the substantive laws of the State of California, without
regard to its conflict of laws provisions.

 

13

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  21.2 Arbitration. Any controversy or claim between the Parties including but
not limited to those arising out of or relating to this Agreement, including any
claims based on or arising from an alleged tort, shall, if they cannot be
settled in a reasonable timeframe by direct negotiation between the Parties, be
determined by arbitration in accordance with the Commercial Arbitration Rules of
the American Arbitration Association (“AAA”) as modified below. All statutes of
limitation which would otherwise be applicable shall apply to any arbitration
proceedings hereunder:

 

  (a) Any arbitration under this Section 21.2 shall be conducted by a panel of
three arbitrators, with each Party selecting one arbitrator and the selected
arbitrators selecting the third arbitrator, provided that the arbitrators
appointed have at least ten (10) years arbitration experience in the
pharmaceutical industry; provided however if the Parties mutually agree, such
arbitration may be conducted by a single mutually agreeable arbitrator.

 

  (b) The award rendered shall be final and binding on the Parties. Judgment
upon the award may be entered in any court having jurisdiction. The Parties
agree that they will not request, and the arbitrators shall have no authority to
award, punitive or exemplary damages against either Party. The costs of any
arbitration, including administrative fees and fees of the arbitrators, shall be
shared equally by the Parties, unless otherwise specified by the arbitrators.

 

  (c) No dispute under this Agreement shall be referred to arbitration under
this Section 21.2 until such dispute has been presented to the respective
presidents or senior executives of PharmaForm and Corcept for their
consideration and resolution.

 

  (d) Notwithstanding any provision of this Agreement, any and all disputes,
controversies or claims relating to intellectual property rights shall be
subject to the exclusive venue and jurisdiction of the state and federal courts
of competent jurisdiction as set forth in Section 21.1. The Parties hereby
consent to the exclusive venue and jurisdiction of such courts for such
disputes, controversies and claims.

 

  (e) Unless otherwise mutually agreed in writing by the Parties, the venue of
the arbitration shall be San Francisco, if initiated by PharmaForm or San Diego,
if initiated by Corcept.

 

22. Insurance

Effective throughout the term of this Agreement, the Parties shall each carry
and maintain in full force and effect, insurance insuring themselves for
commercial general liability, including product liability. Such insurance policy
from an insurance company, each Party shall include the other as an additional
insured thereon; such insurance policies shall be obtained from an insurance
company having a Best’s rating of B+, Class IV or higher. Commercial General
Liability insurance, Umbrella Liability or adequate reserves providing coverage
for liability of not less than [***], Combined Single Limit and Products and
Completed operations Liability Insurance of [***] aggregate, Bodily Injury and
Property Damages shall be secured as of the date of the first commercial
shipment of the Product. Upon written request, each Party shall furnish the
other with certificates of said Commercial General Liability and Product
Liability insurance policy. The indemnification obligations herein shall apply
on a first dollar basis without limitation or reduction due to any deductible or
self-insured retention which either Party may have under their respective
insurance coverage. All insurance policies which are written on a claims made
basis shall include an extended reporting period provision of not less than
three (3) years from the end of such policy period.

 

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

 

14

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23. Representations

 

  23.1 PharmaForm’s Representations. PharmaForm, represents and warrants that:

 

  (a) As of the Effective Date, the Facility is in compliance with Applicable
Laws, and is not subject to a 483 citation;

 

  (b) PharmaForm will perform the manufacturing and processing of Product in
conformance with the Applicable Laws, the Quality Assurance Agreement and the
Specifications, and in accordance with the terms and conditions of this
Agreement;

 

  (c) all Product delivered hereunder shall, at the time of shipment, conform to
the Applicable Laws, the Quality Assurance Agreement and the Specifications, and
in accordance with the terms and conditions of this Agreement;

 

  (d) it has all necessary authority and all right, title and interest in and to
any technology that is required by PharmaForm to perform its obligations set
forth under this Agreement;

 

  (e) neither PharmaForm, its Affiliates or members of their respective staffs,
nor, to the best of PharmaForm’s knowledge, any of their vendors, suppliers, or
subcontractors or any members of each of their respective staffs, are or shall
be, at the time of performance of any manufacturing service hereunder,
(i) disqualified or debarred by any Regulatory Authorities or any other
governmental authority for any purpose pursuant to Applicable Law; or
(ii) charged with or convicted for conduct relating to the development or
approval of, or otherwise relating to the regulation of, any drug product under
any Applicable Law; and

 

  (f) the Facility will remain in compliance with Applicable Laws during the
term of this Agreement.

 

  23.2 Corcept Representations. Corcept, based on its reasonable knowledge,
represents that:

 

  (a) Corcept is in compliance with all Applicable Laws related to the
development, design, marketing and sale of the Product.

 

  (b) the manufacture of Product by PharmaForm in accordance with this Agreement
will not infringe upon the intellectual property rights of any third party.

 

  23.3 PharmaForm’s Covenants.

 

  (a) PharmaForm will maintain all required registrations or licenses with
applicable Regulatory Authorities, such as but not limited to, the FDA, and any
other Federal, state or local agencies so that PharmaForm can perform its
obligations as set forth in this Agreement and PharmaForm will promptly, within
[***] business days, notify Corcept if any such registrations or licenses lapse
or when it determines that it is not in compliance with the requirements for
maintaining such registrations or licenses;

 

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

 

15

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  (b) PharmaForm will comply with all Applicable Laws, in its performance under
this Agreement; and

 

  (c) PharmaForm will operate in accordance with the Quality Assurance Agreement
and will be responsible for all items designated as its responsibility on the
Quality Assurance Agreement.

 

  23.4 Mutual Representations, Warranties and Covenants. Each Party represents,
warrants and covenants that, as of the Effective Date, it;

 

  (a) is a corporation duly organized and validly existing and in good standing
under the laws of its jurisdiction of the organization;

 

  (b) is qualified or licensed to do business and in good standing in every
jurisdiction where such qualification or licensing is required;

 

  (c) has the corporate power and authority to negotiate, execute, deliver and
perform its obligations under this Agreement;

 

  (d) has no obligations or commitments to third parties inconsistent or in
conflict with this Agreement, and during the term of this Agreement with not
enter into any obligations or commitments to third parties inconsistent with or
in conflict with this Agreement; and

 

  (e) has secured all consents and authorizations necessary to enter into this
Agreement and proceed with the undertakings required herein and the execution,
delivery and performance of this Agreement have been duly and validly
authorized.

 

  23.5 Exclusion of Other Representations and Warranties. EXCEPT AS EXPRESSLY
SET FORTH IN THIS AGREEMENT, PHARMAFORM MAKES NO REPRESENTATIONS OR WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY REPRESENTATIONS OR
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT, AND NO PARTY WARRANTS THAT THE OTHER PARTY WILL RECEIVE ANY
PARTICULAR AMOUNT, OR ANY, REVENUES OR PROFITS AS A RESULT OF ENTERING INTO THE
BUSINESS ARRANGEMENTS DESCRIBED IN THIS AGREEMENT.

 

16

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24. Notices

Any notices, reports, consents or requests required or permitted under this
Agreement shall be in writing and deemed to have been given (i) when actually
received; (ii) when delivered personally, (iii) when sent by confirmed
facsimile, (iv) ten (10) business days after having been sent by registered or
certified mail, return receipt requested, postage prepaid; or (v) five
(5) business days after deposit with an internationally recognized commercial
overnight courier specifying next day delivery (if available, or two (2) day
delivery otherwise) with written verification of receipt. All communications
shall be sent to the addresses set forth below:

 

If to PharmaForm:

PharmaForm, LLC

11501 Domain Drive, Suite 130

Austin, TX 78758

Attention: Rudy J. Emmelot

Telephone: (512) 834-0449

Fax: (512) 339-3050

If to Corcept:

Corcept Therapeutics Incorporated

149 Commonwealth Drive

Menlo Park, CA 94025

Attention: Robert L. Roe

Telephone: (650) 327-3270

Fax: (650) 327-3218

 

 

17

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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first written above.

 

CORCEPT THERAPEUTICS INCORPORATED     PHARMAFORM, LLC

149 Commonwealth Drive

Menlo Park, CA 94025

   

11501 Domain Drive, Suite 130

Austin, TX 78757

By:  

/s/ Robert L. Roe

    By:  

/s/ Rudy J. Emmelot

Robert L. Roe

   

Rudy J. Emmelot

(Print Name)     (Print Name)

President

   

President and CEO

(Title)     (Title)

22 March 2012

   

March 21, 2012

(Date)     (Date)

 

Appendix I:    Quality Specification Appendix II:    Prices/Quantities
Appendix III:    Stability Testing Appendix IV:    Corcept Starting Materials
Appendix V:    Quality Assurance Agreement

 

18

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Appendix I: Korlym™ (Mifepristone) Tablets, 300 mg Specification

 

No.

  

Attribute

  

Specification

   Method

1

   Appearance    [***]    [***]

2

   Identification (HPLC)    [***]    [***]

3

   Assay (HPLC)    [***]    [***]

4

   Uniformity of Dosage Units (Weight Variation)    [***]    [***]

5

   Dissolution    [***]    [***]

6

   Impurities    [***]    [***]    [***]

[***]

      [***]    [***]   

7

   Water Determination    [***]    [***]

8

   Microbial Limits   

[***]

[***]

[***]

[***]

  

[***]

[***]

[***]

[***]

   [***]

 

1 

Use [***] to obtain assay value required in [***]

Reference: Drug Product Specification [***]

Appendix II: Prices / Quantities

Price per batch:

$[***]

Appendix III: Stability Testing

Stability Testing Costs

$[***] per time point, per condition, per pull, per lot for first sample

$[***] per time point, per condition, per pull, per lot for first sample

$[***] per time point, per condition, per pull, per lot for additional samples
analyzed at the same time

$[***] per time point, per condition, per pull, per lot for additional samples
analyzed at the same time

Stability Testing attributes as per Specifications

 

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

 

19

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Appendix IV: Corcept Starting Materials

 

Material Name

   Pharmaform
Material
Code   Amount
(g) for
[***]
Tablet
Batch   Material
Ownership:

Purified Water, USP

   [***]   [***]   [***]

Sodium Lauryl Sulfate, NF (Texapon K12 PH)

   [***]   [***]   [***]

Micronized Mifepristone (C-1073)

   [***]   [***]   [***]

Sodium Starch Glycolate, NF (Glycolys LV)

   [***]   [***]   [***]

Hydroxypropyl Cellulose, NF (Klucel EXF Pharm)

   [***]   [***]   [***]

Silicified Microcrystalline Cellulose, NF (Prosolv HD 90)

   [***]   [***]   [***]

Sodium Starch Glycolate, NF (Glycolys LV)

   [***]   [***]   [***]

Magnesium Stearate, NF

   [***]   [***]   [***]

[***]

   [***]   [***]   [***]       

Curtec Keg (Bulk Package)

   [***]   [***]   [***]

 

1 

PharmaForm will source this material and will supply this material in the
quantity required for manufacture of Product. These materials are “PharmaForm
Starting Materials” as defined in Paragraph 4.3 of the Agreement. PharmaForm is
responsible for purchasing and testing these materials at its own cost.

2 

PharmaForm will periodically purchase materials indicated to be supplied by
PharmaForm based on the Corcept supplied forecast, and minimum ordering
quantities. Corcept will reimburse PharmaForm for the cost of these materials
plus [***]. Corcept will pay PharmaForm [***] for the release testing, as per
the Specifications, for each lot of material. These materials are “Corcept Owned
Materials.

3 

Corcept will provide this material directly to PharmaForm. Corcept will pay
PharmaForm [***] for release testing, as per the Specifications, for the first
lot and [***]/lot for each additional lot tested at the same time.

 

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

 

20

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Appendix V: Quality Assurance Agreement

 

Quality Agreement

 

Between

 

PharmaForm, Inc

 

11501 Domain Drive, Suite 130

 

Austin, TX 78758

 

USA

 

&

 

Corcept Therapeutics, Inc.

 

149 Commonwealth Drive

Menlo Park, CA 94025

 

APPROVALS Corcept Therapeutics      PharmaForm Inc

/s/    Robert Roe        

  

3/21/12

    

 

  

 

Robert Roe    Date         Date President           

/s/    Barbara Laidlaw        

  

3/21/12

    

/s/    Kelly Finn        

  

3/26/12

Barbara Laidlaw    Date      Kelly Finn    Date Manufacturing        
Manufacturing   

/s/    Carl Wilson        

  

3/21/12

    

/s/    Monica Gorbet        

  

3/26/12

Carl Wilson    Date      Monica Gorbet    Date Quality Assurance         Quality
Assurance   

--------------------------------------------------------------------------------

Corcept Therapeutics

Quality Agreement

Confidential

TABLE OF CONTENTS

 

1.

   Purpose      23   

2.

   Scope      23   

3.

   Confidentiality      23   

4.

   Effective Period of the Quality Agreement      23   

5.

   Definitions      23   

6.

   Communications      26   

7.

   Regulatory Requirements      26   

8.

   Quality Requirements      27   

Appendix 1. Corcept and PharmaForm Contacts

     30   

Appendix 2. Quality Responsibilities for Corcept and PharmaForm

     31   

 

Page 22 of 34

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Corcept Therapeutics

Quality Agreement

Confidential

 

25. Purpose

The purpose of this Quality Agreement is to define the requirements and
responsibilities of Corcept Therapeutics, Inc. (Corcept), 149 Commonwealth
Drive, Menlo Park, CA, 94025 and PharmaForm, Inc. (PharmaForm), 11501 Domain
Drive, Suite 130, Austin, TX 78758 to ensure that products are manufactured,
packaged, tested, labeled, stored, handled and released in a timely, consistent
and uniform manner and in compliance with current Good Manufacturing Practices
(cGMP)

The Quality Agreement is intended to ensure that activities are performed in
accordance with state and/or local laws, directives, regulations and guidelines,
as may be applicable to the specific project. Requirements may include those
defined by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH), U.S. Food
and Drug Administration (FDA) cGMPs (21CFR Parts 210 and 211) and other
international regulatory requirements.

 

26. Scope

This Quality Agreement covers all quality and regulatory related activities that
are associated with the manufacturing, packaging, labeling, holding, and testing
of drug substance (API) and drug products manufactured by PharmaForm on behalf
of Corcept and is effective once endorsed by both parties.

The Quality Agreement applies to goods and services obtained under contract by
Corcept Therapeutics and is valid in conjunction with the Delivery Agreement. If
there is a conflict between the Delivery Agreement and the Quality Agreement the
terms of the Delivery Agreement will apply.

 

27. Confidentiality

The information contained in this document is confidential and subject to the
terms and conditions of the Confidential Disclosure Agreement (CDA) in place
between PharmaForm and Corcept.

 

28. Effective Period of the Quality Agreement

This Quality Agreement between Corcept and PharmaForm shall commence on the
effective date of the Quality Agreement and remain in effect until PharmaForm
and Corcept terminate the Quality Agreement or it is superseded by a revised
Quality Agreement executed by both parties. This Quality Agreement should be
reviewed at least every two years to ensure that it reflects the current
regulatory climate and industry practices or if changes are made to the Delivery
Agreement.

 

29. Definitions

 

Active Pharmaceutical Ingredient (API):    Any substance intended to be used in
the manufacture of a drug product and that, when used in the production of a
drug, becomes an active ingredient of the drug product. Such substances are
intended to furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease or to affect
the structure and function of the body. Also referred to as drug substance.

 

Page 23 of 34

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Corcept Therapeutics

Quality Agreement

Confidential

 

Audit:    A planned, independent, documented, objective assessment per written
procedures to verify that systems and/or processes have been developed, and are
currently being followed to achieve quality system objectives and/or regulatory
requirements. Batch Record/Batch History:    All documentation associated with
the manufacturing, testing, and release of a batch of API or drug product. The
batch record gives specific instructions on the procedures, calculations,
criteria, sampling, storage conditions and testing performed on a product and
includes a listing of personnel participating in the production and the
equipment and raw materials used during the process. The original, approved
batch record that serves as the template to be completed for each production run
is referred to as the Master Batch Record. Bulk Drug Product:    Product that is
held in bulk prior to being packaged. Certificate of Analysis (COA):    A
document detailing test procedures, specifications and results and signed by an
appropriate second party to assure results are accurate and complete. Deviation:
   A departure from an approved instruction or established standard. A deviation
may be planned to allow a change within cGMP procedures if it does not impact
product strength, identity, safety, purity or quality. An unplanned deviation is
a departure from cGMP practices which has the potential to impact product
strength, identity, safety, purity, quality or usability. Deviation, Major:   
An occurrence that is a significant departure from documented procedures or
specifications that could adversely impact the product quality and may require
good scientific review or medical judgment to resolve. Examples include, but are
not limited to, charging of incorrect materials, equipment malfunctions during
critical operations, or failures during AQL inspections. Disposition:    The
determination of the appropriate status of a product following review of the
batch history and may include release or approval for further manufacturing or
for human use, rejection, quarantine, destruction, or hold. Drug Product:    A
finished dosage form (e.g., tablet) that contains an active ingredient
generally, but not necessarily, in association with inactive ingredients.
Finished Drug Product:    A product that has been packaged and labeled in its
respective packaging configuration.

 

Page 24 of 34

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Corcept Therapeutics

Quality Agreement

Confidential

 

Good Manufacturing Practices/Current Good Manufacturing Practices (GMPs/cGMP):
   Regulations that set forth the minimum current good manufacturing practice
for methods to be used in and the facilities or controls to be used for the
manufacture, processing, packing, or holding of a drug to assure that the drug
meets the requirements of the act as to safety, and has the identity and
strength to meet the quality and purity characteristics that it purports or is
represented to possess. Applicable regulations may include the Code of Federal
Regulations (CFR), Title 21, Parts 210 and 211, International Conference on
Harmonisation (ICH) Harmonised Tripartite Guideline, Good Manufacturing Practice
Guide for Active Pharmaceutical Ingredients, Q7, and EudraLex EU Guidelines to
Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use,
Parts I-III and Annexes. International Conference on Harmonization (ICH):    An
internationally recognized process under which global pharmaceutical guidances
are published and accepted by regulatory agencies, industry and professional
trade organizations on a global basis. In-Process Material:    Any form of a
product that has been processed but does not meet the definition of either
finished or bulk drug product. Examples may include powder blend and packaged
tablets that have not been labeled. Key Contacts:    Persons at PharmaForm and
Corcept assigned to assure proper communication and follow-up in a timely manner
within both parties’ organizations. Names, titles and full contact information
for Key Contacts should be appended to this Agreement and be kept up-to-date
during the course of the project. Delivery Agreement    A legal contract between
Corcept Therapeutics and a supplier of goods and services. The contract
describes, but is not limited to, the product(s) and/or services being purchased
for clinical or commercial use and the general obligations of each party for
maintaining time line, costs, and payment schedules. Out-of-Specification (OOS)
Result:    Any testing result (in-process, release, or stability) that does not
meet specification and for which there was no obvious laboratory error
responsible for the result. Retain Sample:    A sample that will be collected
per 21CFR Part 211.170, that is (1) representative of the batch or given
operation, (2) to be retained in case of an investigation into the batch, and
(3) retained for a period of time as specified in 21 CFR Part 211.170. The
actual quantities will be defined via a sampling plan, but typically are a
minimum of twice the amount required to perform complete release testing.
Sometimes described as a Reserve Sample.

 

Page 25 of 34

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Corcept Therapeutics

Quality Agreement

Confidential

 

Specifications:    Quality standards used to confirm the quality of drug
substances, drug products, intermediates, raw materials, reagents, components,
in-process materials, container closure systems, and other materials used in the
production of a drug substance or drug product. Suspect Result:    Any testing
result that meets a specification but appears to be out-of-trend or considered
abnormal when compared to historical data.

 

30. Communications

Key contacts will be assigned by both parties to assure proper communication and
follow-up in a timely manner. Key contacts shall have access to project managers
and technical staff and, upon reasonable notice and as required, facilitate
resolution of any issues.

Representatives from both Corcept and PharmaForm Quality Assurance departments
will be involved in decision-making and resolution of quality issues. All
resolutions and action items will be documented in writing.

PharmaForm will not use in the performance of services for Corcept, presently or
in the future, the services of any person debarred or subject to debarment under
21 U.S.C. § 335(a). PharmaForm will immediately notify Corcept in writing if any
person who is performing services under contract is or becomes debarred or if
there are legal or administrative actions pending that would preclude PharmaForm
from performing its obligations under this Agreement.

A list of contacts for both Corcept and PharmaForm is included in Attachment 1.

31. Regulatory Requirements

PharmaForm must comply with federal, state, and local ordinances regarding
hazardous waste and environmental effects as a result of manufacturing
activities and maintain appropriate establishment registrations and
certifications necessary to manufacture the products.

Corcept will have all regulatory responsibilities for the product including
submitting or updating the CMC section of appropriate regulatory submissions.
PharmaForm will provide all necessary documentation to Corcept for such
submissions. Corcept will notify PharmaForm in writing of any changes in the
regulatory filing status of the Drug Product, and of any changes in the intended
use of the Drug Product or a change in its classification.

Corcept is responsible for submitting the NDA Annual Report as well as all other
pre- or post-approval amendments and/or supplements to active US and non-US
regulatory filings. As requested, PharmaForm will be responsible for providing
Corcept with the annual update information 30 calendar days prior to the
anniversary date of the NDA or another anniversary date stipulated by Corcept.
The cutoff date for reporting of data will be 60 calendar days prior to the
anniversary date.

Regulatory authority inquiries to PharmaForm regarding Corcept products will be
forwarded to Corcept. Discussions with regulatory authorities regarding Corcept
product shall be conducted only with appropriate Corcept representation.

 

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Corcept will work jointly with PharmaForm in preparation for any regulatory
inspection that affects Corcept. PharmaForm is responsible for hosting any
inspection and Corcept will have personnel on site at PharmaForm during an
inspection to serve in a supporting role. Corcept personnel will include one
person each from manufacturing, quality, and regulatory, with the possibility
for one additional person to be determined at Corcept’s discretion (for a
maximum total of four people); PharmaForm may request additional personnel
beyond the maximum total. PharmaForm will notify Corcept, to the extent possible
in advance, of any proposed inspection. Corcept will similarly notify PharmaForm
of any proposed inspection.

PharmaForm will notify Corcept within [***] business days of an advance notice
by any Regulatory Authority of their intent to visit the facility. If PharmaForm
is not provided any advance notice, such notification will be within one
business day of the arrival of inspectors. For routine inspections Corcept
personnel will not participate in the audit, but will be available for updates,
consultation, and advice on product specific issues.

Any commitment to a regulatory agency that directly impacts Corcept’s
application will be discussed and agreed upon with Corcept before being provided
to the agency. PharmaForm will retain a duplicate sample of any item sampled by
any regulatory agency.

Corcept will review and comment on any part of an official PharmaForm response
that specifically addresses a Corcept product and will be provided with a
complete redacted copy of any official documentation as provided by the
regulatory agency conducting the audit. PharmaForm’s redacted formal response
will also be provided to Corcept.

PharmaForm will notify Corcept as soon as reasonably possible of any event that
incites a field alert per 21CFR 314.81, and the District Office within 3 working
days of a confirmed event.

32. Quality Requirements

A table summarizing the Corcept and PharmaForm responsibilities for Quality is
included in Appendix 2.

Record Retention: PharmaForm will retain all original records (e.g., Batch
Records, testing raw data) per 21 CFR part 211.180 and notify Corcept at least
[***] days prior to any impending end to a record retention period. At the end
of the record retention period, the original record will be provided to Corcept
unless otherwise instructed, in writing, by Corcept. PharmaForm will provide
copies of executed Batch Records and product testing records to Corcept.

Change Control: For documents originating at PharmaForm, requiring both
PharmaForm and Corcept approvals, PharmaForm will review, approve and route to
Corcept for review and approval. For documents originating at Corcept, Corcept
will review, approve and route to PharmaForm. Corcept QA is responsible for
notifying Corcept Regulatory Affairs department of any change that may be
applicable to regulatory filings. Generally, Corcept must approve of any change
that could affect the quality of Corcept’s product. Approvals for specific items
under change control are delineated in Appendix 2. All change proposals must be
accompanied by a written supportive rationale and justification.

Specifications and Test Methods: Corcept is responsible for establishing product
specifications. PharmaForm may recommend or review any proposed specification
change but will not change any specification without the prior written approval
of Corcept. Corcept will work with PharmaForm to establish required
non-compendial test methods. Non-compendial test methods will be validated and
include appropriate test elements and acceptance criteria described in a
validation protocol to demonstrate acceptable method performance within
PharmaForm testing laboratories. PharmaForm may recommend changes to validated
methods but will not change any method without the prior written approval of
Corcept and the completion of any required validation activities.

 

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

 

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Corcept Therapeutics

Quality Agreement

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Raw Materials: PharmaForm supplied raw materials must be certified to comply
with current Transmissible Spongioform Encephalopathy (TSE) guidelines.

Product Disposition: Corcept will perform the final disposition on the Product.
The decision will be based on independent review of the completed batch records
(copies provided by PharmaForm), the PharmaForm Certificate of Analysis (COA),
and any additional related documentation (e.g., deviations, investigations). In
addition, the following will apply:

 

  1. All discrepancies will be resolved by both parties prior to either party
dispositioning a material.

 

  2. PharmaForm will provide Corcept with written documentation for each lot of
Product stating that the associated batch records, testing data and test results
have been reviewed according to PharmaForm procedures and that the product has
been produced according to GMP and list any deviations associated with the
Product lot.

 

  3. In cases of dispute, either party may request the review and recommendation
of an independent third party. In such cases, Corcept QA will consider the
recommendation; however, Corcept QA will make the final disposition decision.

Retain Samples: PharmaForm will obtain and maintain official commercial Retain
Samples for Corcept according to an approved sampling plan. Under this
responsibility, Corcept will retain samples of each lot of the following
materials:

 

Material Type

  

PharmaForm Retain

Active Pharmaceutical Ingredient (API)

   Optional or Yes depending on whether retain is held at API site

Bulk Drug Product

   Yes

Finished Drug Product

   No

Labels

   No

Excipients

   Yes

Components

   Yes

Vendor Qualification and Materials: Corcept is responsible for qualifying the
supplier of the API and any contract testing laboratories that conduct testing
under Corcept direction. Corcept will supply PharmaForm with a list of vendors
qualified by Corcept. PharmaForm is responsible for qualifying (or providing
equivalent to qualification) of all other suppliers or vendors, as applicable,
according to PharmaForm’s vendor qualification procedures.

Validation Activities: PharmaForm is responsible for drafting process,
analytical methods, and packaging validation protocols and reports, as required,
according to PharmaForm procedures. Corcept and

 

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Corcept Therapeutics

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PharmaForm are both responsible for reviewing and approving such protocols.
These responsibilities also apply to any supportive studies that would be
performed under specific protocols (e.g., experimental batch protocols, recovery
study protocols).

Product Investigations: PharmaForm is responsible for conducting investigations
concerning Product quality issues that may arise from manufacturing deviations
(pre-disposition) or from Product complaints (post-disposition). Corcept may
assist during an investigation. Corcept Quality unit must approve the final
investigation conclusion.

Product Complaints: Corcept, or its designee, is responsible for receipt and
processing of Product complaints. PharmaForm is responsible for conducting
investigations related to Product complaints as described above.

Material Storage: PharmaForm is responsible for storing all materials (e.g.,
API, excipients, components) according to their required storage conditions and
for storing the drug product (bulk and finished) according to the required
storage conditions and status. PharmaForm is responsible for storing the
manufactured drug product until shipment to a Corcept packager.

Stability: PharmaForm may be responsible, as agreed upon, for drafting,
reviewing and approving stability protocols for Corcept product. PharmaForm is
also responsible for obtaining samples, storage of samples under the appropriate
conditions, sample pulls, testing, reporting results, and for raw data
retention. Corcept is responsible for reviewing and approving all protocols,
sampling plans, and test results. Corcept is also responsible for the
preparation of interim or final stability reports. PharmaForm will notify
Corcept within [***] if any stability test result is confirmed to be out of
specification.

Man-in-the-Plant: Corcept reserves the right to have Corcept personnel or a
representative of Corcept on site during manufacturing of drug product (either
QA or manufacturing, or both). Corcept personnel will act as observers or be
available for consultation. PharmaForm will ultimately be responsible for
production execution, documentation, and decisions made during manufacturing,
except where such responsibilities are delineated in this agreement. If Corcept
personnel observe any activity that could compromise product quality or is
counter to cGMP, Corcept QA will contact PharmaForm QA with the observation.
Corcept personnel will not sign any manufacturing document unless the document
specifies a client signature or if directed by PharmaForm and Corcept QA.

Product Recalls: Corcept is responsible for initiating a product recall.
PharmaForm may be responsible to assist in quarantining any inventory at
PharmaForm.

Annual Audits: Corcept will perform once per calendar year an annual audit as a
part of vendor qualification. The annual audit will be arranged at a minimum of
two weeks prior to the audit due date. Corcept QA will lead the audit. Corcept
may perform additional audits as mutually agreed solely to the extent necessary
to address specific quality problems with the Drug Product.

Reprocessing/Reworking: PharmaForm must obtain written approval from Corcept
prior to reprocessing any product.

Shipping Under Quarantine: Prior to shipment of any product under quarantine
(e.g., prior to the completion of release testing), Corcept must provide written
authorization to PharmaForm ensuring that the product will not enter the
marketplace until release is completed.

 

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

 

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Corcept Therapeutics

Quality Agreement

Confidential

 

Appendix 1. Corcept and PharmaForm Contacts

 

Functional Area

  

Corcept

  

PharmaForm

Main

   (650) 327-3270    (512) 834-0449

Facsimile (FAX)

   (650) 327-3218    (512) 339-3050

Mailing Address

  

149 Commonwealth Drive

Menlo Park, CA 94025

   11501 Domain Drive

Suite 130

Austin, TX 78758

Business Development

  

###### ###

#########

(###) ###-####

####@#######.###

   ###### ###########

###-###-####

############@##########.###

Manufacturing

  

####### #######

(###) ###-####

########@#######.###

   ##### ####

(###) ###-####

#####@##########.###

Quality Assurance

  

#### ######

(###) ###-####

#######@########.###

   ###### ######

(###) ###-####

########@##########.###

Regulatory Affairs

  

###### ######

(###) ###-####

############@#########.###

   N/A

 

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Corcept Therapeutics

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Appendix 2. Quality Responsibilities for Corcept and PharmaForm

 

Description of Task

  

Corcept

  

PharmaForm

  

Comments

Product Disposition

 

Final Release (Corcept)

   X

 

X

   X    Corcept QA is responsible for final disposition and release. PharmaForm
will disposition according to PharmaForm procedures. Corcept will notify
PharmaForm, in writing, of the final disposition and release.

Product Complaint Investigations

 

Product Related Adverse Event Investigations

   X

 

X

   X

 

X

   Corcept is responsible for handling product complaints and adverse events.
Investigations may include PharmaForm.

Product Specifications

         PharmaForm to review and comment on any proposed change to a
specification. PharmaForm may propose changes or propose other limits. No change
may be made without the written agreement of Corcept and PharmaForm.

 

•    Establishing

  

 

X

  

 

X

  

 

•    Changes

  

 

X

  

 

X

  

 

•    Action Limits

  

 

X

  

 

X

  

Test Methods

         Test methods may be originated and validated at PharmaForm or
transferred from Corcept (or Corcept contracted laboratory). Transferred methods
will be validated to the extent required to demonstrate performance by
PharmaForm. Changes and revalidation will be executed by the same procedure.

•    Validation

 

•    Changes

   X

 

X

   X

 

X

           

 

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Corcept Therapeutics

Quality Agreement

Confidential

 

Description of Task

  

Corcept

  

PharmaForm

  

Comments

Starting/Raw Materials Vendor Qualification

 

         Corcept will qualify API Vendor. PharmaForm is responsible for all
other vendor qualifications. Corcept must approve all vendors selected and any
vendor changes.

•     API

   X      

 

•     All other components

  

 

X

  

 

X

  

Manufacturing

         PharmaForm to provide any proposal and supporting justification for
process changes to Corcept. Corcept to notify FDA. Copies of relevant FDA
communications will be provided to PharmaForm by Corcept.

 

•     Master Batch Sheet Review and Approval

  

 

X

  

 

X

  

 

•     Processing

        

 

•     Executed Record Review

     

 

X

  

 

•     Process Changes Review and Approval

  

 

X

  

 

X

  

 

•     FDA Notification

  

 

X

  

 

X

  

 

•     Process Validation Protocols/Reports Review and Approval

  

 

X

     

 

•     Cleaning Validation (Product Specific)

  

 

X

  

 

X

  

 

•     General Cleaning Validation

               X         

 

X

   Process Related Variances or Deviations          PharmaForm QA will notify
Corcept QA of a Major Deviation or variance within [***]. All deviations or
variances will be approved by both Corcept and PharmaForm as part of batch
record review.

 

•     Deviation Review and Approval

        

 

•     Investigations

  

 

X

  

 

X

        

 

X

  

 

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

 

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Corcept Therapeutics

Quality Agreement

Confidential

 

Description of Task

  

Corcept

  

PharmaForm

  

Comments

Product Release Testing          PharmaForm is responsible for any in-process
and release testing. PharmaForm will generate an approved COA and Corcept will
review the COA as part of batch record review. PharmaForm will notify Corcept QA
within one business day of a confirmed OOS result.

 

•    Release Testing

     

 

X

  

 

•    COA

     

 

X

  

 

•    Release Testing Data and COA Review

  

 

X

  

 

X

  

 

•    OOS Investigation

        

 

•    OOS Investigation Review

  

 

X

  

 

X

 

X

   Product Recalls    X    X    Corcept is responsible for determining when to
execute any product recall. Corcept will notify PharmaForm when a recall is
being considered. If required, PharmaForm will support a recall effort.
Stability Testing          Corcept is responsible for expiration dating and
establishing stability specifications. PharmaForm will supply stability data to
Corcept as required. PharmaForm to notify Corcept within 1 business day of
observing any confirmed suspect result.

 

•    Protocols

  

 

X

  

 

X

  

 

•    Sample Storage

     

 

X

  

 

•    Testing

     

 

X

  

 

•    Data and Report Review

  

 

X

  

 

X

  

 

•    Expiration Dating

  

 

X

     

 

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Corcept Therapeutics

Quality Agreement

Confidential

 

Description of Task

  

Corcept

  

PharmaForm

  

Comments

Product Storage         

PharmaForm may be requested to store quantities of API that exceed immediate
manufacturing needs. PharmaForm will store bulk drug product on a short-term or
interim basis until shipment to a packager.

Note: Only Corcept released product will be shipped from PharmaForm

 

•    In-Process

     

 

X

  

 

•    Final Product

     

 

X

  

 

•    Distribution/Repository

  

 

X

      Annual Product Reviews (APR)    X    X    Corcept is responsible for
assembling a Corcept APR based upon Corcept procedures. PharmaForm is
responsible for preparing an APR according to PharmaForm procedures. PharmaForm
will provide any data requested by Corcept for completion of the APR. PharmaForm
and Corcept will conduct a final review together of Corcept APR sections that
affect the PharmaForm operations.

 

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