Document:

License and Settlement Agreement

 Exhibit 10.1 
 EXECUTION COPY 
 CONFIDENTIAL 

SUBJECT TO U.S. FEDERAL RULE OF EVIDENCE 408 
 LICENSE AND SETTLEMENT AGREEMENT 
 THIS LICENSE AND SETTLEMENT
AGREEMENT is made as of April 30, 2012 (the “Effective Date”) by and between CONCEPTUS, INC., a Delaware corporation (“Conceptus”) and HOLOGIC, INC., a Delaware corporation (“Hologic”).

 RECITALS 
 WHEREAS, Conceptus and Hologic are involved in litigation related to the Adiana Product, the use of which Adiana Product has been found by the United States District Court of the Northern District
of California (the “Northern District of California”) to infringe U.S. Patent No. 6,634,361 owned by Conceptus, and the Northern District of California has entered a judgment against Hologic, that among other things, requires
Hologic to pay Conceptus $18.8 million in damages and post-judgment interest (the “Adiana Judgment”); 

WHEREAS, Hologic has initiated an appeal with respect to the Adiana Judgment, and Conceptus has initiated a cross-appeal with
respect to other rulings in the California Litigation (as defined herein), before the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) in Conceptus, Inc. v. Hologic, Inc., Appeal Nos. 2012-1209,
-1219 (Fed. Cir. 2012) (the “Federal Circuit Appeal”), the opening brief for which is due upon April 30, 2012; 
 WHEREAS, the commercial performance and profitability of the Adiana Product commercially available as of the date hereof have fallen short of Hologic’s expectations; 

WHEREAS, Hologic has determined to discontinue and wind up its current business in the PBC Field; 

WHEREAS, Conceptus and Hologic are also involved in litigation in the United States District Court for the District of
Massachusetts (the “District of Massachusetts”) related to the patent marking of Conceptus’s Essure permanent birth control system; and 
 WHEREAS, to avoid the uncertainty and cost of further litigation and to settle all past and present claims between Conceptus and Hologic, whether known or unknown, Conceptus and Hologic have agreed
to enter into this Agreement. 
 NOW THEREFORE, in consideration of the premises and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, Conceptus and Hologic agree as follows: 
 I.
DEFINED TERMS; INTERPRETATION 
  

	1.1	Definitions 

 The
following capitalized terms when used in this Agreement shall have the respective meanings set forth below. Terms capitalized and defined elsewhere in this Agreement, including the preamble hereto, shall have the respective meanings specified
herein. 
 “Affiliate” means any Entity that Controls, is Controlled by, or under common Control with the
Entity in question. 

  
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 “Agreement” means this License and Settlement Agreement, including all
of its recitals and schedules, all as may be amended from time to time in accordance with its terms. 
 “Adiana
Business” means the operations and activities used for production, development, testing and research, marketing, regulatory approval, sales, distribution and maintenance of the Adiana Product. 

“Adiana Judgment” has the meaning set forth in the Recitals to this Agreement. 

“Adiana PMA” means P070022, the Premarket Approval granted by the FDA to Hologic with respect to the Adiana Product, and
all amendments thereto. 
 “Adiana Product” means Hologic’s Adiana Permanent Contraception product as
described in the Adiana PMA or any foreign marketing authorization. 
 “All Litigation” means all of the
actions, suits and proceedings filed, pending or stayed between the Parties as of the Effective Date, including the California Litigation, the Massachusetts Litigation and the Federal Circuit Appeal. 

“California Litigation” means Conceptus, Inc. v. Hologic, Inc., Case No. 3:09-cv-02280-WHA (N.D. Cal.
2009). 
 “Claim(s)” means any claims, counterclaims, demands, debts, dues, liabilities, actions or causes of
action of any kind and of whatsoever nature or character, arising in any jurisdiction in the world or available under any state, local, provincial, federal or international law, or the law of any country (or any other act, action, administrative
rule or procedure, legislation or regulation of any kind or description), regardless of whether existing in the past or present (or whether accrued, actual, contingent, latent or otherwise), made or brought (a) for the purpose of recovering any
damages (including any actual, general, specific, direct, indirect, commercial, economic, consequential, incidental, special, punitive, exemplary or treble damages and any loss of revenue, loss of expected profits or expected savings, extradition of
infringer’s profits, fines, monetary penalties, court costs, interest, pre judgment and post judgment interest, attorney’s fees, expert fees and any other related costs or expenses) or (b) for the purpose of obtaining any equitable
relief or any other relief of any kind, including any and all of the foregoing that were alleged or could have been alleged in the Litigation. The term “Claims” shall specifically include known or unknown or suspected or unsuspected claims
that are based on acts or omissions occurring on or before the Effective Date. 
 “Conceptus Affiliate” means
any present or future Affiliate of Conceptus, including an Affiliate of Conceptus as of or after the Effective Date. 

“Conceptus Contractor” means, in respect of Conceptus and Conceptus Affiliates, a past, present or future direct or
indirect distributor, supplier, dealer, reseller, sales agent, sales representative, service provider, subcontractor or manufacturer, of Conceptus Products and Services, solely when and to the extent that an Entity is acting in this capacity.

  
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 “Conceptus Customer” means, in respect of Conceptus and Conceptus
Affiliates, a past, present or future customer or subscriber of Conceptus or Conceptus Affiliates or user of Conceptus Products and Services including any health-care provider, physician, patient or other individual who acquires or is provided with
a technology, product or service that is included in the definition of Conceptus Products and Services, and any Entity whose members, partners, employees, agents, patients, customers, or contractors acquire, are provided with or use a technology,
product or service that is included in the definition of Conceptus Products and Services but only to the extent that the activities of such “Conceptus Customers” relate to Conceptus Products and Services. 

“Conceptus Patent” means U.S. Patent No. 6,634,361. 

“Conceptus Products and Services” means the technologies, products and services of Conceptus and Conceptus Affiliates as
of the Effective Date and all future technologies, products and services of Conceptus and Conceptus Affiliates, including any device, disposable, tool, product design or service developed, supplied, sold, distributed or otherwise provided by or on
behalf of Conceptus or a Conceptus Affiliate. 
 “Conceptus Release” means the release granted by Conceptus to
Hologic in Section 4.1(a). 
 “Control” (and its correlative terms “Controlled” and
“Controlling”) means (a) direct or indirect ownership or control of more than fifty percent (50%) of the voting interests or securities of an Entity, (b) the ability to elect a majority of the board of directors or
other governing body for the Entity, or (c) in relation to a partnership, limited liability company or other unincorporated association, the right to a share of more than half of its net assets or net income. 

“District of Massachusetts” has the meaning set forth in the Recitals to this Agreement. 

“Entity” means any legal entity including a corporation, unincorporated organization, association, limited liability
company, partnership, trust, business trust, joint venture, or sole proprietorship, governmental organization or body, or any agency, department or instrumentality thereof, and includes a natural person. 

“FDA” means the United States Food and Drug Administration. 

“Federal Circuit” has the meaning set forth in the Recitals to this Agreement. 

“Federal Circuit Appeal” has the meaning set forth in the Recitals to this Agreement. 

“Hologic Affiliate” means any present or future Affiliate of Hologic, including an Affiliate of Hologic as of or after
the Effective Date. 
 “Hologic Patents” means: (a) the Patents and Patent applications described on the
attached Schedule A; and (b) all parent applications, originals, divisionals, continuations, continuations-in-part, continuation prosecution applications, provisional applications, reissues, re-examinations, extensions, patents of
importation, patents of addition or foreign counterparts of 

  
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any of the foregoing Patents and Patent applications described under clause (a) above, and all Patents claiming priority based on any of the foregoing, and “Hologic Patent”
means any one of the foregoing. 
 “Hologic Release” means the release granted by Hologic to Conceptus in
Section 4.1(b). 
 “License” means the license granted by Hologic to Conceptus as set forth in
Section 4.2. 
 “Massachusetts Litigation” means Hologic, Inc. v. Conceptus, Inc., Case
No. 1:10-cv-11355-PBS (D. Mass. 2010). 
 “Northern District of California” has the meaning set forth in
the Recitals to this Agreement. 
 “Party” means each of Conceptus and Hologic, as the context may require, and
“Parties” means Conceptus and Hologic collectively. 
 “Patent(s)” means all classes or types
of issued patents and all issued claims therein, utility models, applications for all classes or types of utility patents or utility models, and any patents or utility models that issue from such applications in all countries of the world, including
all originals, divisionals, continuations, continuations-in-part, continuation prosecution applications, provisional applications, reissues, re-examinations, extensions, patents of importation or patents of addition to any of the foregoing.

 “PBC Field” means the field of transcervical sterilization by application of radio frequency energy to, and
deployment of an implant in, the fallopian tube, including but not limited to any device, apparatus, system, composition, method or other application used in or for planning, treating, deploying, testing or achieving permanent birth control by
transcervical application of radio frequency energy to, and deployment of an implant in, the fallopian tube. 

“Regulatory Approval” means, a product has passed all reasonably required testing and has received all necessary
regulatory authorizations anywhere in the world, including FDA marketing authorization (510(k) clearance or Premarket Approval) in the United States, and is ready to be manufactured, marketed, sold and immediately delivered to end-user
customers for clinical use in such jurisdiction. 
 “Releases” means collectively the Conceptus Release and the
Hologic Release. 
 “Royalty” and “Royalties” have the meanings set forth in
Section 4.2(b). 
 “Royalty-Bearing Product” means a product that has obtained Regulatory Approval for
applications in the PBC Field and: (a) is sold commercially and placed into commerce by or on behalf of Conceptus; (b) is covered by an issued claim under one or more of the Hologic Patents that has not been finally and without right of
appeal rendered invalid or unenforceable; and (c) applies radio frequency energy to a patient’s fallopian tubes. 

“SMT License Agreement” means that certain Patent License Agreement dated as of November 28, 2001 by and among
Adiana, Inc., a California corporation, SM Technologies LLC, a limited liability corporation of Utah, and William J. Seare, Jr., MD, an individual, attached hereto as Schedule C. 

  
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 “Sold by or on behalf of Conceptus” has the meaning set forth in
Section 4.2(c). 
 “Third Party” means an Entity other than Conceptus, Hologic, any Conceptus Affiliate,
and any Hologic Affiliate. 
 II. SETTLEMENT OF THE LITIGATION 

 

	2.1	Settlement of the California Litigation 

 (a) Hologic covenants that it shall cease, directly or indirectly, making, having made, offering for sale, selling, having sold, using, licensing, importing, promoting, distributing and otherwise
disposing of the Adiana Product and shall cease all activities related to the Adiana Business in all jurisdictions, except for the actions winding up the Adiana Business which Hologic shall undertake as listed and according to the schedule
set forth on Schedule B attached hereto; provided, however, that Hologic may continue to perform the regulatory actions required by applicable law that are related to the Adiana Product, as set forth on Schedule E.

 (b) The Parties shall file (i) with the Federal Circuit, on or before the Effective Date, a joint motion to remand the
Federal Circuit Appeal of the California Litigation to the Northern District of California in accordance with the form attached hereto as Schedule D, and subsequently (ii) with the Northern District of California, within five
(5) business days of the Federal Circuit’s grant of the motion referenced in clause (i) of this sentence, a joint motion for entry of a consent judgment permanently enjoining Hologic from making, having made, using, offering for sale,
selling, having sold, licensing, importing, promoting, distributing or otherwise disposing of the Adiana Product, except to the extent any of the foregoing is necessary to perform an action required or permitted of Hologic as set forth respectively
on Schedule B and Schedule E, in accordance with the form attached hereto as Schedule D. 
 (c) If the
Northern District of California denies the motion for entry of a consent judgment as requested by the Parties in clause (ii) of Section 2.1(b), then Conceptus agrees to refrain from executing on the Adiana Judgment and shall not seek the
damages awarded thereunder for so long as Hologic adheres to all of its obligations under Sections 2.1(a) and 8.2 and all of its representations and warranties under Section 5.2 and it remains in compliance with the terms and conditions of this
Agreement. Further, in the event that Hologic breaches any obligations under either of Sections 2.1(a) or 8.2, or any of its representations and warranties under Section 5.2, Conceptus shall be entitled to seek relief for any damages accruing
subsequent to July 1, 2011, including but not limited to damages based on a claim for Patent infringement, notwithstanding the Conceptus Release. 
  

	2.2	Settlement of the Massachusetts Litigation 

 On or before the Effective Date, the Parties shall jointly file a request for dismissal with prejudice of the Massachusetts Litigation by filing a joint motion for dismissal with prejudice in the form
attached hereto as Schedule D, or by such other procedure as agreed to between the Parties or which may be otherwise necessary under the local rules of the District of Massachusetts to dismiss the Massachusetts Litigation. 

  
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	2.3	No Admission; Denial of Liability 

 The Parties acknowledge and agree that none of the execution of this Agreement, the granting of the Releases and the License, or the exchange of any other consideration pursuant to this Agreement shall be
construed as an express or implied admission of misconduct, responsibility, or any liability whatsoever on the part of the Parties or of anyone else, and the Parties expressly and specifically deny all such admissions. Rather, it is acknowledged and
agreed that this Agreement has been entered into solely for the purpose of settling and compromising All Litigation, to avoid the expense and uncertainty of continued litigation, and to give effect to Hologic’s decision to wind-down the Adiana
Business. 
  

	2.4	Final Settlement 

Subject to Section 2.1(c), the Parties agree that this Agreement is a full, final and complete settlement of all Claims released
herein. 
  

	2.5	Fees, Costs and Expenses 

 The Parties acknowledge and agree that each Party shall each bear its own attorney’s fees, court costs, expenses, and any other related costs and expenses that it has incurred in connection with All
Litigation and this Agreement. 
 III. LIQUIDATED DAMAGES 

 

	3.1	Liquidated Damages 

Conceptus’s remedy for Hologic’s breach of any of its obligations in either of Sections 2.1(a) or 8.2, or any of its
representations and warranties under Section 5.2, for prior damages accruing through June 30, 2011, shall be liquidated damages in the amount of $18.8 million specified in the Adiana Judgment, which liquidated damages shall be available to
Conceptus if Hologic does not cure any such applicable breach within thirty (30) days of receiving written notice from Conceptus identifying the breach. The Parties agree that the harm caused to Conceptus from Hologic’s breach of any of
its obligations in either of Sections 2.1(a) or 8.2, or any of its representations and warranties under Section 5.2, would be difficult to quantify and determine, and accordingly the Parties agree in advance to the application and assessment of
the aforementioned liquidated damages as an approximation of the damage suffered by Conceptus through June 30, 2011. Further, in the event that Hologic breaches any of its obligations under either of Sections 2.1(a) or 8.2, or any of its
representations and warranties under Section 5.2, Conceptus may pursue relief for any damages accruing subsequent to July 1, 2011, including but not limited to damages based on a claim for Patent infringement, notwithstanding the Conceptus
Release. Notwithstanding the foregoing, if the Northern District of California grants the motion for entry of a consent judgment as requested by the Parties in clause (ii) of Section 2.1(b), the liquidated damages remedy set forth in this
Section 3.1 shall only be available to Conceptus for Hologic’s breach of any of its obligations under Section 8.2 or any of its representations and warranties under Section 5.2. 

  
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 IV. RELEASES; LICENSE 

 

	4.1	Releases 

 (a)
Subject to Hologic’s compliance with the terms and conditions of this Agreement, Conceptus, for itself and for its Affiliates, and its and their respective successors and assigns, hereby irrevocably settle, release, and forever discharge any
and all Claims that have been or could have been brought by Conceptus or any of its Affiliates against Hologic, its Affiliates or its or their respective officers, directors, employees, shareholders or attorneys, in All Litigation, including, for
the avoidance of doubt, the California Litigation. 
 (b) Hologic, for itself and for its Affiliates, and its and their
respective successors and assigns, hereby irrevocably settle, release, and forever discharge any and all Claims that have been or could have been brought by Hologic or any of its Affiliates against Conceptus, its Affiliates or its or their
respective officers, directors, employees, shareholders or attorneys, in All Litigation, including, for the avoidance of doubt, the Massachusetts Litigation. 
  

	4.2	License; Royalties 

(a) Hologic hereby grants, and shall cause any Hologic Affiliate that owns or has the right to license any Hologic Patent to hereby grant,
to Conceptus, Conceptus Affiliates, Conceptus Contractors and Conceptus Customers an irrevocable, world-wide, royalty-bearing, nonsublicenseable, non-transferable (except in accordance with Section 8.2) and non-exclusive license under the
Hologic Patents in the PBC Field: (i) to make, have made, use, sell, offer to sell, practice, lease, keep, import, have imported, export, have exported, distribute (including through multiple channels of distribution), commercially exploit or
otherwise dispose of Conceptus Products and Services; and (ii) to practice any method or process claimed in the Hologic Patents for purposes of effectuating the license granted in clause (i) of this Section 4.2(a). 

(b) For each Royalty-Bearing Product Sold by or on behalf of Conceptus in the United States after the Effective Date and until the
earlier of the expiration of the last-to-expire of the Hologic Patents or the termination by Conceptus of the License as set forth in Article VII, Conceptus shall pay to Hologic an amount equal to five percent (5%) of the actual selling price
(i.e. revenue received per unit sold) of such Royalty-Bearing Product (each such per unit amount a “Royalty” and collectively, the “Royalties”). 

(c) Conceptus shall pay all Royalties owed to Hologic for Royalty-Bearing Products Sold by or on behalf of Conceptus in each calendar
quarter within forty-five (45) days following the end of such calendar quarter. All Royalties shall be paid by Conceptus in U.S. dollars. A Royalty-Bearing Product is “Sold by or on behalf of Conceptus” under this Agreement
upon first transfer pursuant to the license granted in Section 4.2(a). Internal sales to Conceptus Affiliates (e.g. for transfer pricing) do not qualify as being Sold by or on behalf of Conceptus hereunder. A Conceptus Product and Service that
is distributed for internal research purposes within Conceptus, or that is made available for clinical or preclinical research or trials, is not a Royalty-Bearing Product and is not considered Sold by or on behalf of Conceptus, even if such product
otherwise satisfies the definition of a Royalty-Bearing Product under this Agreement. 

  
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 (d) Following the termination or expiration of this Agreement or the License as set
forth in Article VII, Hologic retains the right to collect from Conceptus any Royalties earned but not paid prior to such termination or expiration. 
 (e) During the term of this Agreement and for one (1) year following its termination or expiration, Conceptus shall maintain the records necessary to determine the accuracy of its payment of
Royalties. Hologic shall have the right, not exercisable more than once per year, at Hologic’s sole expense, to appoint an independent, Third Party auditor, subject to Conceptus’s reasonable approval, who shall be given access by Conceptus
to those records which are reasonably required in the judgment of the auditor to determine the accuracy of Conceptus’s payment of Royalties. Any audits required hereunder shall be conducted at a time reasonably convenient to Conceptus, and in a
manner that does not interfere with Conceptus’s business and operations. Any books and records provided to the auditor hereunder shall be maintained in confidence by such auditor and shall not, nor shall any summaries or notes thereof, be
disclosed to Hologic, to any Hologic Affiliate, or to any Third Party. 
 V. REPRESENTATIONS AND WARRANTIES 

 

	5.1	Conceptus Representations and Warranties 

 Conceptus represents and warrants to Hologic that: 
 (a) it is a corporation duly
organized, validly existing and in good standing under the laws of Delaware and it and each of its Affiliates is currently operating as a going concern and it is not, and none of its Affiliates are, subject to any bankruptcy, insolvency, liquidation
or similar proceedings; 
 (b) it has all corporate power and authority necessary to enable it to enter into this Agreement, to
carry out the transactions contemplated by this Agreement, and to bind Conceptus and its Affiliates to each and every obligation hereof; 
 (c) it has duly executed this Agreement which is a valid agreement, binding on and enforceable against Conceptus in accordance with its terms and covenants, and Conceptus shall ensure that its Affiliates
shall comply with this Agreement and that Conceptus shall be vicariously liable for any failure of its Affiliates to do so; 

(d) it and/or its Affiliates own (i) one hundred percent of all of the Claims that it and any of its Affiliates have asserted in All
Litigation, and (ii) one hundred percent of all of the Claims that it and its Affiliates are releasing through the Conceptus Release; 
 (e) except for the California Litigation, neither Conceptus nor any Conceptus Affiliate has, or intends to bring, any lawsuits, claims, complaints or actions in its or their names, or on behalf of or
through any other Entity, against Hologic or any Hologic Affiliate in any court or other proceeding, or before any government agency or entity; and 
 (f) neither it nor any of its Affiliates has entered into nor shall enter into any other arrangement with any Entity that would preclude Conceptus or the Conceptus Affiliates from effectuating and
fulfilling its or their obligations under this Agreement or granting the rights granted herein. 

  
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	5.2	Hologic Representations and Warranties 

 Hologic represents and warrants to Conceptus that: 
 (a) it is a corporation
organized and existing under the laws of Delaware and it and each of its Affiliates is currently operating as a going concern and neither it nor any of its Affiliates are, subject to any bankruptcy, insolvency, liquidation or similar proceedings;

 (b) it has all power, capacity and authority necessary to enable it to enter into this Agreement, carry out the transactions
contemplated by this Agreement and to bind Hologic, its Affiliates and its and their successors and assigns to each and every obligation hereof; 
 (c) it has duly executed this Agreement which is a valid agreement, binding on and enforceable against Hologic in accordance with its terms and covenants and Hologic shall ensure that its Affiliates shall
comply with this Agreement and Hologic shall be vicariously liable for any failure of its Affiliates to do so; 
 (d) it and/or
its Affiliates own (i) one hundred percent of all of the Claims that it and any of its Affiliates have asserted in All Litigation, and (ii) one hundred percent of all of the Claims that it and its Affiliates are releasing through the
Hologic Release; 
 (e) it owns one hundred percent of the Hologic Patents and to the extent that it does not, it has sufficient
rights from the Hologic Affiliates or Third Parties to grant the License with respect to all Hologic Patents; 
 (f) it has not
breached the SMT License Agreement and is current in all of the obligations it owes under the SMT License Agreement to the other parties thereto; 
 (g) except for the Massachusetts and California Litigations, neither Hologic nor any of the Hologic Affiliates has, or intends to bring, any lawsuits, claims, complaints or actions in its or their names,
or on behalf of or through any other Entity, against Conceptus or any Conceptus Affiliate in any court or other proceeding, or before any government agency or entity; 
 (h) neither it nor any of its Affiliates has entered into nor shall enter into any other arrangement with any Entity that would preclude Hologic or the Hologic Affiliates from effectuating and fulfilling
its or their obligations under this Agreement or granting the rights granted herein; 
 (i) Schedule A sets forth a
complete and accurate list of all of the Patents and Patent applications owned or controlled by Hologic that cover the PBC Field; 
 (j) it and/or its Affiliates shall make any transfer or other dealings with any Hologic Patents or the Adiana Business (i) subject to the Hologic Release and the License and (ii) conditioned on
the purchaser, assignee or licensee of the Hologic Patents expressly agreeing to be bound by the Hologic Release, the License and Sections 2.1(a) and 2.1(c); 

  
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 (k) neither it nor any of its Affiliates has as of the Effective Date any plans to
perform or cause to be performed any action regarding the Adiana Product or the Adiana Business that is not set forth on either of Schedule B or Schedule E; and 
 (l) neither it nor any of its Affiliates has as of the Effective Date any plans to file or prepare any supplements to the Adiana PMA or any foreign marketing authorization. To the extent any supplement to
the Adiana PMA or any foreign marketing authorization has been filed, Hologic will withdraw such supplement as set forth on Schedule B. 
 VI. CONFIDENTIALITY; NON-DISPARAGEMENT 
  

	6.1	Confidentiality of Agreement 

 Neither Party may disclose the terms and conditions of this Agreement to any entity or person except that each Party may disclose the terms and conditions of this Agreement: (i) to Third Parties with
a need for access pursuant to the order or requirement of a court, administrative or regulatory agency, or other governmental body, provided that the Party required to make such a disclosure gives as much notice as is reasonably possible to the
other Party to contest such order or requirement; (ii) on a confidential basis to its legal, accounting or financial advisors solely for the purposes of providing such advice and solely to the extent that they have a need for access and have
agreed to keep such information confidential; (iii) as required under applicable securities regulations or listing agency requirements, provided that the disclosing Party uses all commercially reasonable efforts to have any sensitive
information redacted, subject to applicable regulations or requirements; (iv) in its financial statements as it is required to do under applicable generally accepted accounting principles while acting in reliance on its auditors, provided that
the disclosing Party uses all commercially reasonable efforts to have any sensitive information redacted, subject to applicable regulations or requirements; or (v) upon the express written consent of the other Party. Any press releases
announcing the existence of this Agreement, or the terms and conditions of this Agreement, must be approved in writing in advance by each Party. 
  

	6.2	Non-Disparagement 

Each Party agrees not to disparage the products or services of the other Party for one (1) year following the Effective Date.

 VII. TERM AND TERMINATION 
  

	7.1	Term of Agreement 

The term of this Agreement shall commence as of the Effective Date and shall remain in full force and effect until the expiration of the
last-to-expire of the Hologic Patents. The following Sections shall survive expiration of this Agreement: 1.1, 2.1(a), 2.1(c), 2.3, 2.4, 3.1, 4.1, 4.2, 6.1, 7.1, 7.2, 8.1 – 8.14, 8.19 and 8.20. 

  
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	7.2	Right to Terminate 

Neither Party shall have the right to terminate this Agreement for any reason; provided, however, that Conceptus shall have the
right to terminate the License granted hereunder at any time for any reason or no reason upon thirty (30) days prior written notice to Hologic. 
 VIII. GENERAL 
  

	8.1	Dispute Resolution 

(a) If there is a dispute between the Parties solely with regard to either (x) those Royalty-Bearing Products for which a Royalty is
owed, or (y) the determination of whether a product or service is an “Adiana Product” subject to the restrictions set forth in Section 2.1(a), then in each instance in respect of clauses (x) or (y), the Parties agree to
submit such dispute to three (3) independent Patent attorneys selected by the Parties in the manner set forth in Section 8.1(e). The Parties agree to be bound by such Patent attorneys’ decision under this Section 8.1. The Parties
agree to provide such attorneys information that the attorneys believe is necessary to resolve such dispute. Such information shall be provided in writing, and stipulated to by the producing Party. There shall be no depositions taken or allowed
under this Section 8.1. The Parties agree to each bear half of the fees and expenses charged by such attorneys. The Parties shall conduct dispute resolution under this Section 8.1 according to the following procedure: 

(b) To the extent that either Party wishes to resolve the issue of (i) whether or not any Conceptus Product and Service is a
Royalty-Bearing Product for which a Royalty is owed or (ii) whether or not any product or service is an Adiana Product, then in respect of clauses (i) or (ii), such Party shall provide written notice to the other Party and identify the
products at issue (the “Disputing Party”). 
 (c) Within ten (10) days of receiving the written notice provided
in Section 8.1(b), the Party receiving such written notice (the “Responding Party”) shall respond in writing stating whether the Responding Party agrees or disagrees as to whether or not such products identified in the notice are
Royalty-Bearing Products or Adiana Products hereunder, as applicable. 
 (d) To the extent that the Parties disagree as to
whether or not products identified in the notice are Royalty-Bearing Products or Adiana Products, as applicable, the Parties shall attempt to resolve the dispute within fifteen (15) days after the Disputing Party receives the response provided
in Section 8.1(c). 
 (e) If the Parties are unable to resolve the issue, the Parties shall, within thirty (30) days
after the Disputing Party receives the response provided in Section 8.1(c), select and retain three (3) independent patent attorneys who shall resolve the dispute, provided that each such attorney shall have at least ten (10) years
experience prosecuting or litigating Patents in the field of life sciences. Each Party shall have the right to select one (1) of the three (3) independent Patent attorneys, and the third and final such attorney selected shall be selected
by the two (2) Patent attorneys, and agreed to by the Parties. None of the three (3) attorneys shall be deemed “party arbitrators”; all shall be expected to be neutral. 

  
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 (f) Within forty-five (45) days of their retention as provided in
Section 8.1(e), the independent Patent attorneys shall reach a determination as to whether the identified products are Royalty-Bearing Products or Adiana Products, as applicable, and in the event that the independent Patent attorneys determine
that the identified products are Royalty-Bearing Products or Adiana Products, as applicable, the relief afforded may include but is not limited to a decision enjoining prohibited actions. A majority decision of the independent Patent attorneys shall
be binding upon the Parties. 
 (g) The entire dispute resolution specified in this Section 8.1 shall take no longer than
ninety (90) days. 
  

	8.2	Assignment 

 (a)
No Assignment. Neither Party may assign or transfer this Agreement without the express written consent of the other Party, which shall be granted or withheld in the non-assigning Party’s sole discretion. Notwithstanding the foregoing,
either Party may freely assign this Agreement without the consent of the other Party (i) to an Affiliate of the assigning Party, or (ii) to the Third Party purchaser of, or successor to, such assigning Party or all or substantially all of
the business of the assigning Party, whether by sale of stock, equities or assets or by merger, reorganization, operation of law, or otherwise. This Agreement shall apply to and shall be binding on the purchaser of any or all of the Hologic Patents
and/or the Adiana Business. Hologic shall condition any sale, assignment, license or transfer of any rights in the Hologic Patents and/or the Adiana Business on the express acknowledgement and agreement of the purchaser, assignee or licensee of the
Hologic Patents and/or the Adiana Business being bound by the Hologic Release, the License and Hologic’s obligations under Article II as set forth herein, it being the express intent of the Parties that no subsequent claims under the Hologic
Patents shall be asserted by any party against Conceptus, any Conceptus Affiliate, or any party to which the Hologic Release and/or the License hereunder are granted (or to which such Hologic Release or the License otherwise apply). From the
Effective Date until the date of expiration of the Conceptus Patent, Hologic shall not assign, transfer or license to a Third Party, or authorize the disclosure to a Third Party by the FDA or other entity, the Adiana PMA and all foreign and domestic
equivalents or any data or information filed in support of any of the foregoing, and any assignment or transfer from Hologic to a Third Party otherwise permitted under this Section 8.2(a) must exclude the assignment, transfer or license of the
Adiana PMA and such data and information. 
 (b) Void Assignments; Successors and Assigns. Any purported assignment other
than in accordance with this Section is void, null and of no effect. 
  

	8.3	Benefit of the Agreement 

 Subject to the provisions of Section 8.2, this Agreement will inure to the benefit of, and be binding upon, the respective heirs, executors, administrators, other legal representatives, successors
and permitted assigns of the Parties and their respective Affiliates hereto. 

  
 12 

 CONFIDENTIAL 

SUBJECT TO U.S. FEDERAL RULE OF EVIDENCE 408 
  

	8.4	Nature of Rights 

Hologic and Conceptus expressly acknowledge and agree that: (i) the License is subject to Section 365(n) of the United States
Bankruptcy Code as a license of “Intellectual Property” and shall be deemed to be, and construed as, license for purposes of application of Section 365 of the United States Bankruptcy Code; and (ii) if a case under the United
States Bankruptcy Code is filed by or against Hologic, and in that case this Agreement is rejected pursuant to Section 365 of the United States Bankruptcy Code, then Conceptus may exercise all rights provided by Section 365(n), including
the right to retain its rights and the full benefits under the License not to be sued under the Hologic Patents. Hologic hereby expressly further acknowledges and agrees that neither Hologic, as debtor-in-possession in any bankruptcy proceeding, any
trustee in bankruptcy, or any successor of Hologic shall challenge the characterization of the License as a license of “Intellectual Property” for purposes of application of Section 365(n) of the United States Bankruptcy Code. Upon
any bankruptcy or insolvency of a Party, such Party shall not be entitled to assume or assume and assign this Agreement or any of its rights hereunder without the express written consent of the other Party. 

 

	8.5	Entire Agreement 

This Agreement constitutes the entire agreement between the Parties hereto with respect to the subject matter hereof and thereof and
cancels and supersedes any prior understandings and agreements between the Parties hereto with respect thereto. There are no representations, warranties, terms, conditions, undertakings or collateral agreements, express, implied or statutory,
between the Parties other than as expressly set forth in this Agreement. 
  

	8.6	Construction 

 In
this Agreement words importing the singular number include the plural and vice versa, words importing any gender include all genders and words importing persons include individuals, partnerships, associations, trusts, unincorporated
organizations and corporations. The term “including” means “including without limiting the generality of the foregoing” and “including but not limited to.” The term “such as” means “such as without
limiting the generality of the foregoing.” The division of this Agreement into Articles and Sections and the insertion of headings are for convenience of reference only and shall not affect the construction or interpretation of this Agreement.
The terms “hereof’, “hereunder,” “herein” and similar expressions refer to this Agreement and not to any particular Article, Section or other portion hereof. Unless something in the subject matter or context is
inconsistent therewith, references herein to Articles, Sections and Schedules are to Articles and Sections of, and Schedules to, this Agreement. 
  

	8.7	Statutory References 

 In this Agreement, unless something in the subject matter or context is inconsistent therewith or unless otherwise herein provided, a reference to any statute is to that statute as now enacted or as the
same may from time to time be amended, re-enacted or replaced and includes any regulations made thereunder. Notwithstanding the above, the Parties intend that any patent exhaustion defenses available as of the Effective Date of this Agreement shall
continue to apply regardless of the state of the law at the time of interpretation. 

  
 13 

 CONFIDENTIAL 

SUBJECT TO U.S. FEDERAL RULE OF EVIDENCE 408 
  

	8.8	Severability 

 In
the event that any term or provision of this Agreement is deemed invalid, unenforceable or void by a final, non-appealable judgment of a court of competent jurisdiction, the remainder of the Agreement shall be interpreted to the extent possible to
effect the overall intention of the Parties as of the Effective Date of this Agreement. 
  

	8.9	Modification 

 This
Agreement may not be amended, modified or altered in any way, except in a writing identified as such and signed by both Parties. 
  

	8.10	Non-Waiver 

Neither Party may waive or release any of its rights or interests under this Agreement except in writing. A waiver by either Party of any
provision of this Agreement shall not be construed as a waiver of any other provision, nor shall such waiver operate as or be construed as a waiver of any future event or circumstance. No single or partial exercise by a Party of any right or remedy
precludes or otherwise affects the exercise of any other right or remedy to which that Party may be entitled. 
  

	8.11	No Joint Venture or Agency 

 Nothing contained in this Agreement or the performance thereof is intended to or shall be construed to create any relationship of agency, partnership or joint venture between or among the Parties.

  

	8.12	Notices 

 All
notices, requests, approvals, consents and other communications required or permitted under this Agreement will be in writing and addressed as follows: 
 If to Hologic: 
 Hologic, Inc. 

250 Campus Drive 

Marlborough, MA 01275 
 Attn: General Counsel 
 If to Conceptus: 

Conceptus, Inc. 

331 East Evelyn Avenue 
 Mountain View, CA 94041 
 Attn: General Counsel 

  
 14 

 CONFIDENTIAL 

SUBJECT TO U.S. FEDERAL RULE OF EVIDENCE 408 
  

 and will be sufficiently given if delivered by hand or sent by certified mail (return receipt
requested), courier, or facsimile (provided that the receiver acknowledges receipt of the facsimile) addressed to the other Party at the address set forth above or to such other person or address as the Parties may from time to time designate in
writing delivered pursuant to this notice provision. Any such notices, requests, demands or other communications will be deemed to be delivered when received by the Party to whom they were addressed. 

 

	8.13	Breach and Remedies 

A breach of any of the terms of this Agreement, including the material falsity of any representation or warranty, and the failure to
perform under any covenant or agreements herein, shall entitle the non-breaching Party to exercise any and all remedies available at law or in equity, subject only to any express limitations stated in this Agreement. Except as expressly provided
herein, in no event shall the Releases, the License or any payments or payment obligations under this Agreement be revoked, rescinded, or terminated for any reason. 
  

	8.14	Governing Law 

This Agreement is governed by and will be construed in accordance with the laws of the State of California and the federal laws of the
United States as applicable therein, without regard to the laws of those jurisdictions governing conflicts of laws. 
  

	8.15	Binding Agreement 

The Parties agree that this Agreement is a binding agreement and all that is required to bind the Parties to the terms of this Agreement
is the signature of the representatives of both Parties in the spaces provided below. 
  

	8.16	Counterparts 

 This
Agreement may be signed in two or more identical counterparts each of which will be deemed to be an original and all of which together will constitute one and the same instrument. 

 

	8.17	Facsimile or E-mail Execution 

 Signing of this Agreement and transmission by facsimile document transfer or by email in PDF format will be acceptable and binding upon the Parties hereto. 

 

	8.18	Further Assurances 

The Parties agree to execute, acknowledge, and deliver all such other instruments and documents and to take any and all further action
consistent with the terms of this Agreement as may be reasonably required to effect the specified intent and purpose of this Agreement or by any of the courts in All Litigation for the purpose of implementing this Agreement. 

  
 15 

 CONFIDENTIAL 

SUBJECT TO U.S. FEDERAL RULE OF EVIDENCE 408 
  

	8.19	Advice of Counsel; Joint Preparation 

 The Parties acknowledge that (a) they have been represented by legal counsel during the negotiation of this Agreement and that their attorneys have fully advised them concerning their rights,
remedies, and obligations under this Agreement and that they understand the same, and (b) this Agreement shall not be construed more favorably in favor of one Party than another based upon which Party drafted same, it being acknowledged and
agreed that each of the Parties contributed substantially to the negotiation and preparation of this Agreement. 
  

	8.20	Waiver of Section 1542 of the California Civil Code 

 The Parties to this Agreement hereby expressly waive the provisions of Section 1542 of the California Civil Code, which states as follows: “A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE
CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM MUST HAVE MATERIALLY AFFECTED HIS SETTLEMENT WITH THE DEBTOR.” 

[Signature Pages to follow] 

  
 16 

 IN WITNESS WHEREOF the Parties have executed this Agreement. 

 

			
	HOLOGIC, INC.
		
	By:	 	 /s/ Robert Cascella

	Name: Robert Cascella
	Title: President and CEO
	Date: 4/29/2012
	
	CONCEPTUS, INC.
		
	By:	 	 /s/ D. Keith Grossman

	Name: D. Keith Grossman
	Title: President and CEO
	Date: 4/29/2012

  
 Signature Page
to License and Settlement Agreement 

 Schedule A 
 Patents that Cover the PBC Field 
  

					
	Patents	  	
			
	 	  	Patent/Publication #	  	Title
			
	1	  	US7905880 B2	  	Method and apparatus for tubal occlusion
			
	2	  	US7842035 B2	  	Method and apparatus for tubal occlusion
			
	3	  	US7582085 B2	  	Catheter placement detection system and operator interface
			
	4	  	US7220259 B2	  	Method and apparatus for tubal occlusion
			
	5	  	US6780182 B2	  	Catheter placement detection system and operator interface
			
	6	  	US6726682 B2	  	Method and apparatus for tubal occlusion
			
	7	  	US6712810 B2	  	Method and apparatus for tubal occlusion
			
	8	  	US6346102 B1	  	Method and apparatus for tubal occlusion
			
	9	  	US6309384 B1	  	Method and apparatus for tubal occlusion
			
	10	  	US5681572 A	  	Porous Material Product and Process
			
	11	  	US5624674 A	  	Porous Product Mold Form
			
	12	  	US5605693 A	  	Methods of Making a Porous Device
			
	13	  	US5589176 A	  	Methods of Making a Doubly Porous Device
			
	14	  	US5954715	  	Method and apparatus for tubal occlusion
		
	Applications	  	
			
	1	  	US20110276070 A1	  	Radiopaque implant
			
	2	  	US20110180073 A1	  	Sterilization device and method
			
	3	  	US20110146692 A1	  	Implant delivery device
			
	4	  	US20110040146 A1	  	Method and apparatus for tubal occlusion
			
	5	  	US20100063360 A1	  	Side-arm port introducer
			
	6	  	US20090036840 A1	  	Atraumatic ball tip and side wall opening
			
	7	  	11/562,882	  	Delivery Catheter with Implant Ejection Mechanism
			
	8	  	12/940,698	  	Unpublished
			
	9	  	12/950,901	  	Unpublished
			
	10	  	13/034,103	  	Unpublished
			
	11	  	13/036,686	  	Unpublished
			
	12	  	13/091,881	  	Unpublished

 SMT License Agreement. 

 Schedule B 
 Adiana Business Wind-Down Schedule 
  

	1.	Hologic shall notify customers and distributors that shipments of Adiana Product will cease by April 30, 2012. 

 

	2.	Hologic shall (a) cease making and having made the Adiana Product by the Effective Date and (b) cease offering for sale, selling, having sold, licensing,
importing or otherwise disposing of the Adiana Product by May 18, 2012. As of the Effective Date, Hologic shall not actively promote or market the Adiana Product, give customers incentives to purchase, or sales personnel incentives to
sell, any Adiana Product, or discount or donate any Adiana Product for any reason, including as part of the sale of non-Adiana Products; provided, however, that Hologic may, until May 18, 2012, take and fulfill orders received
from existing customers from existing inventory provided that such orders may not exceed such customer’s total unit order for the previous quarter. 

  

	3.	To the extent any of the Adiana Product cannot be reconfigured for use in products outside the PBC Field, Hologic shall cause the disposal of all Adiana Product stock
held in inventory by May 31, 2012. 

  

	4.	To the extent any supplement to the Adiana PMA or any foreign marketing authorization has been filed, Hologic will withdraw such supplement as soon as reasonably
practicable. 

 SCHEDULE C 
 SMT License Agreement 
  

					
		 		 	  
 UNITED STATES DISTRICT COURT
 NORTHERN DISTRICT OF CALIFORNIA

		 		 	 
		 		 	TRIAL EXHIBIT 655
		 		 	CASE NO. 3:09-CV-02280-WHA
		 		 	DATE ENTERED            
                             
		 		 	BY                 
                                         
           
		 		 	 DEPUTY
CLERK
  

 PATENT LICENSE AGREEMENT 
 This Patent License Agreement is entered into as of this 28th day of November, 2001 between Adiana, Inc., a California corporation (“Adiana”) having its principal place of business in Redwood
City, California, and SM Technologies LLC, a Limited Liability Corporation of Utah (“SMT”) having its principal place of business in Salt Lake City, Utah. 
 1. RECITALS 
 a) Adiana designs, manufactures and markets medical devices and components
used in gynecological applications and procedures. 
 b) SMT is the exclusive owner of all right, title and interest in certain United States
Patents covering various porous material compositions and methods for making them. 
 c) SMT is willing to grant, and Adiana desires to acquire
an exclusive license to the patents covering various porous material compositions and methods for making them. 
 d) In consideration of the
mutual promises and covenants of the parties contained in this Agreement, the sufficiency of which is hereby acknowledged, the parties agree as follows: 
 2. DEFINITIONS 
 As used in this Agreement: 

a) “Affiliate” shall mean any corporation, company or business (i) in which Adiana owns or controls at least fifty percent (50%) of
the voting stock, (ii) which owns or controls at least fifty percent (50%) of the voting stock of Adiana, or (iii) which is owned or controlled by any person or entity that owns or controls at least fifty percent (50%) of the
voting stock of Adiana. 
 b) “Catheter” shall mean a device used to deliver and deposit an occlusive mass in any lumen, duct,
orifice, or opening of the reproductive system of humans or animals. 
 c) “Field of Use” shall mean any use for occlusion of any
lumen, duct, orifice, or opening of or for the female reproductive system of humans or animals. 
 d) “License” shall mean
Adiana’s license pursuant to Section 3 to make, have made, use, sell, offer for sale, import, lease and/or commercialize Licensed Products throughout the world. 
 e) “Licensed Patents” shall mean: 
  

	 	i)	United States Patent 5,681,572, issued October 28, 1997, entitled “Porous material product and process” and 

 

	 	ii)	United States Patent 5,605,693, issued February 25, 1997 entitled “Methods of making a porous device” and 

 

	 	iii)	United States Patent 5,624,674, issued April 29, 1997, entitled “Porous product mold form” and 

 

	 	iv)	United States Patent 5,589,176, entitled “Methods of making doubly porous device” and 

 
  

					
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		 	1	 	

	 	v)	any and all continuations, continuations-in-part, continuing prosecution applications, applications subject to requests for continued examination, reissues, divisions,
renewals, reexamination certificates, additions or extensions of such patent, together with any and all foreign counterparts of each patent Licensed Patent. 

 f) “Licensed Product” shall mean any method or device within the Field of Use that incorporates any subject matter which is covered by, or the use of which is covered by, a valid, unexpired and
uncancelled claim of a Licensed Patent, including any such method or device which improves or modifies a previously developed Licensed Product while remaining covered by a valid, unexpired and uncancelled claim of a Licensed Patent. 

g) “Matrix” and “Matrices” shall mean a component or components of a Catheter intended for deposit into any lumen, duct, orifice, or
opening of the female reproductive system of humans or animals. 
 h) “Seare” shall mean William J, Seare, Jr., MD, an individual.

 i) “Net Catheter Sales” shall mean the gross number of Catheters incorporating Licensed Products sold by Adiana, its Affiliates or
sublicensees, less any catheters returned to Adiana by purchasers for credits, exchanges or replacements. 
 j) “Sale” shall mean any
sale or other disposition of a Licensed Product for value. 
 3. GRANT OF LICENSE 

a) On the terms and conditions set forth in this Agreement, SMT hereby grants to Adiana the exclusive worldwide right, privilege and license under the
Licensed Patents to make, have made, use, sell, offer for sale, import, lease and/or otherwise commercialize any and all Licensed Products within the Field of Use. 
 b) The License shall be exclusive to Adiana and SMT shall not grant to any other person or entity besides Adiana any license under the Licensed Patents within the Field of Use. 

c) The License shall include the right to grant sublicenses within the Field of Use, subject to any sublicensee agreeing in writing to be bound by all of
the obligations under this Agreement, including the payment of royalties and reporting requirements. SMT shall be given a copy of each sublicense under this Agreement. No SMT Confidential Information may be provided to such sublicensee without first
affording SMT a reasonable opportunity to investigate the potential sublicensee and approve of such disclosure, which approval shall not be unreasonably withheld. 
 d) SMT hereby grants to Adiana the right to extend the licenses granted or to be granted in Section 3(a) to an Affiliate subject to the terms and conditions hereof. 

e) To the extent that Adiana is granted the right to file suit and/or initiate and maintain litigation to prevent third parties from infringing upon any
Licensed Patent; the License shall include the right to recover damages for any past infringement of such Licensed Patent. 

4. PAYMENTS AND ROYALTIES 

a) In consideration of the License and SMT’s other obligations under this Agreement, Adiana agrees as follows: 

b) Upon execution of this Agreement, Adiana shall pay to SMT a fee of fifty thousand dollars ($50,000). 

 

					
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		 	2	 	

 c) On December 31, 2001 and again on December 31, 2002, Adiana shall pay SMT a “Minimum
Royalty” of twenty thousand dollars (320,000). Beginning January 1, 2002, Adiana agrees to enter a separate agreement with Seare (the “Seare Consulting Agreement”) for fifteen thousand dollars ($15,000) a year for consulting
services for two (2) years. After two (2) years, the Minimum Royalty shall be increased to thirty-five thousand dollars ($35,000), and will remain constant thereafter. Minimum Royalty payments by Adiana to SMT under this Section 4(c)
shall be reduced by any royalties paid by Adiana to SMT pursuant to Section 4(d) below and shall be pro-rated for partial years. 
 d) Upon
commencement of this Agreement, Adiana shall pay to SMT a royalty fee of $1.25 per Net Catheter Sale utilizing one or more of the Licensed Patents. Payment shall be due at the time of delivery of each quarterly statement provided for in
Section 4(f) for Net Catheter Sales during the preceding Fiscal Quarter. 
 e) Adiana shall pay to SMT a reduced royalty fee of $0,625 per
Net Catheter Sale in countries where the Licensed Patents are not effective, have expired, or have not been sought. 
 f) Adiana shall deliver
to SMT, within forty-five (45) days following the end of each calendar quarter, a written statement showing Adiana’s Net Catheter Sales and the calculation of royalty payments due to SMT under Sections 4(d). Such statement shall include
data reasonably necessary to facilitate verification of the royalty calculations. 
 g) All royalties shall be paid in United States dollars.

 h) Adiana shall keep complete and accurate books of account containing Licensed Products sales, Net Catheter Sales and other data in
sufficient detail to enable the royalties payable under this Agreement to be computed and verified. Adiana agrees that SMT and his agents shall have the right, at SMT’s expense and subject to Section 5, upon reasonable prior written
notice, not more than once in any calendar year, to examine Adiana’s royalty calculations and to inspect and copy during normal business hours such books of account and Adiana’s other records, but only to the extent that they reasonably
relate to royalty payments under this Agreement. 
 5. CONTINUED DISCLOSURE OF TECHNOLOGY 

a) SMT shall disclose to Adiana any development related to the Licensed Products, including any know-how pertaining to manufacture and use of Licensed
Products, and shall disclose, on a continuing basis, the best known mode for practicing any claimed subject matter of the Licensed Patents. 

b) Through the Seare Consulting Agreement, discussed in Section 4(c) above, Seare shall provide “reasonable efforts” to Adiana to assist
in development of Licensed Products and procurement of United States Food and Drug Administration (“FDA”) approval of Licensed Products in the Field of Use. 
 c) In order to facilitate or otherwise support submissions for regulatory approval of any product that relies upon Licensed Patents, each party shall have the right, without charge, to refer to. access,
cross-reference and use all documents that are owned or controlled by the other party which are submitted to any regulatory agency in order to obtain or maintain marketing approval for products that rely upon Licensed Patents (“Filed
Data”). These documents include, without limitation, the SMT and Adiana Master File for Devices, as filed with the FDA, and any applicable European equivalent, as updated from time to time, which is required for some portion of the manufacture
and testing of Licensed Products. 
 d) During the Term, upon written request from SMT, Adiana shall provide, at no charge, reasonable amounts
of technical assistance to SMT to provide responses to questions related to the Licensed Patents. 
  

					
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		 	3	 	

 e) Data obtained by Adiana that is: (i) directly related to the Licensed Patents, (ii) contained
in FDA filings, and (iii) reduced to written form (“Adiana Matrix-Specific Filed Data”) will be provided to SMT. It is agreed by SMT and Seare that Adiana Filed Data is Confidential Information (as defined in Section 8 below). Adiana
Matrix-Specific Filed Data may be placed into SMT’s Master File for Devices and/or Seare’s Master File for Devices. 
 f) Filed Data
will be summarized into a document describing the Filed Data in sufficient detail to apprise Adiana of the subject matter of all documents, including Third Party Filed Data (“Summary”). At least once each year, SMT agrees to provide Adiana
a copy of the Summary as well as a similar summary for any data from all third party licensees of the Licensed Patents. 
 g) SMT may permit
SMT’s third party licensees of the Licensed Patents the right, without charge, to access, reference, cross-reference and use Adiana Matrix-Specific Filed Data provided that: (i) the third party licensee has similarly submitted data that is
directly related to the Licensed Patents (“Third Party Filed Data”) to SMT’s Master File for Devices and/or Seare’s Master File for Devices, (ii) the third party licensee has agreed to permit Adiana the right, without
charge, to access, reference, cross-reference and use Third Party Filed Data; (iii) that SMT has notified Adiana prior to the third party’s access, reference, cross-reference or use of Filed Data; and (iv) the third party licensee has
agreed that Adiana Matrix Specific Filed Data is Confidential Information and has, in writing, agreed to the provisions contained in Section 9 below. 
 6. NON-COMPETITION 
 Non-competition. SMT represents and warrants that SMT will not, during
the term of this License Agreement, perform any consulting services that could reasonably be determined to be in the Field of Use for any company, person or entity whose business or proposed business in any way involves products or services that
could reasonably be determined to be in the Field of Use. Seare represents and warrants that Seare will not, during the term of this License Agreement, perform any consulting services that could reasonably be determined to be in the Field of Use for
any company, person or entity whose business or proposed business in any way involves products or services that could reasonably be determined to be in the Field of Use. 
 7. OWNERSHIP OF EMERGENT PATENTS 
 a) In the event that either party conceives patentable
subject matter during the performance of this Agreement (“Emergent Technology”), the party conceiving Emergent Technology shall own any patents which it might obtain covering such patentable subject matter (“Emergent Patents”),
No license shall be implied for any Emergent Patent obtained by either party, and any Emergent Patent obtained will be outside the scope of this Agreement. 
 b) In order to allow Adiana the opportunity to maximize its ability to capitalize on Licensed Patents within the United States and foreign markets, Seare proposes that Adiana and Seare work toward
obtaining additional US and Foreign patents. It is the opinion of Seare that confidential disclosures Seare has made, and contemplates making to Adiana prior to the execution of this Agreement, or after execution hereof, with respect to work done by
him prior to the date of this Agreement, comprise additional patentable intellectual property. These disclosures have and will relate to the optimum performance of Licensed Products and Licensed Patents for the Field of Use. Seare may elect, at his
own discretion, to seek US and/or foreign patents with respect to inventive concepts which are related to the Licensed Patents and are in existence prior to the date of this Agreement. On a case by case basis, Seare is willing to allow Adiana an
opportunity to bring such new patent applications and resultant patents within the scope of the Licensed Patents, provided that Adiana agrees, within thirty days of notice, to participate in 
  

					
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		 	4	 	

 
the costs of the patent preparation, filing and prosecution in accordance with the cost sharing provisions set forth in Section 7(c), except that Adiana’s obligations to share in such
costs shall start as soon as Adiana elects to include such patent application disclosure within the scope of the Licensed Patents. If Adiana elects not to accept the obligations to share costs immediately under the cost sharing provisions of
Section 7(c), then any patent applications and resultant patents shall fall outside of the Licensed Patents. 
 c) In the event that either
SMT and Adiana, or Seare and Adiana, jointly conceive Emergent Technology, such Emergent Technology shall be jointly owned by SMT and Adiana. SMT, Seare and Adiana agree to assist in filing and prosecuting patents containing jointly developed
Emergent Technology. Any royalties or other payments that may derive from jointly developed Emergent Technology shall be shared by SMT and Adiana in a ratio equal to the costs borne by SMT and Adiana to prosecute such jointly developed Emergent
Patents. 
 8. CONTINUED OBLIGATION TO PROSECUTE AND MAINTAIN PATENTS 

a) SMT shall, at its own expense, prosecute the Licensed Patents and any continuations, divisions, continuations-in-part, and reissues of such patent
application or any patent thereon, until all applicable patents issue. SMT shall also pay any maintenance fees on the Licensed Patent and any patents that issue on any continuations, divisions, continuations-in-part, and reissues of the Licensed
Patents. If for any reason SMT intends to abandon any continuations, divisions, continuations-in-part, and reissue applications of any Licensed Patent, SMT shall notify Adiana at least two (2) months in advance of any such abandonment and
Adiana shall have the exclusive right to take over prosecution of any such application or maintenance requirements for any such patents. SMT shall cooperate with Adiana in any reasonable manner Adiana requires regarding the prosecution of any
application or other requirement related to this effort, at Adiana’s expense. 
 b) SMT shall, at its own expense, continue prosecution of
any existing corresponding foreign applications of any Licensed Patent, until all applicable patents issue. SMT shall also pay any maintenance fees, taxes or annuities that are due on any foreign patents and patent applications, If for any reason
SMT intends to abandon any existing corresponding foreign applications of any Licensed Patent, SMT shall notify Adiana at least two (2) months in advance of any such abandonment and Adiana shall have the exclusive right to take over prosecution
of any such application or maintenance requirements for any such patents. SMT shall cooperate with Adiana in any reasonable manner Adiana requires regarding the prosecution of any application or other requirement related to this effort, at
Adiana’s expense. 
 d) Adiana shall own the rights within its Field of Use with respect to any patent application for which it takes over
prosecution, and shall also own the rights within its Field of Use with respect to any patent issuing on any patent application for which it takes over prosecution. Adiana shall be entitled to reduce royalty fees, including Minimum Royalties, that
may be owed by Adiana to SMT pursuant to Section 4, by an amount equal to the costs incurred by Adiana related to taking over prosecution or maintenance and such patent applications and patents shall no longer be a Licensed Patent once Adiana
assumes responsibility for such patent applications and patents. There shall be no royalty obligation to SMT with respect to the practice of the claims of such patent applications and/or patents, although this provision shall have no effect upon
Adiana’s obligation to pay royalties with respect to the remaining Licensed Patents. 
 9. CONFIDENTIAL INFORMATION

 a) Confidentiality of Information. Neither party shall intentionally disclose to any other person, firm, or corporation (other than to
personnel of affiliated companies with a need to know and who receive such information subject to the same restrictions as are contained in this Agreement), or use for its own benefit, 
  

					
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		 	5	 	

 
except as provided in this Agreement, any information it receives from the other party that is designated in writing as “Proprietary” or “Confidential,” whether documentary,
oral, or, if demonstrative, is designated in writing by the disclosing party within three months following disclosure as “Proprietary” or “Confidential” (hereinafter “Confidential Information”). No information shall be
designated or marked as Proprietary or Confidential unless the disclosing party has reason to believe that the information is Proprietary and Confidential. 
 b) Permitted Uses. The recipient party agrees that it will only use the disclosing party’s Confidential Information for the purpose of pursuing the objectives of this Agreement, including developing
an FDA approved medical device, maintaining License and royalty payments, and incorporation of Licensed Patents into medical devices. 
 c)
Standards of Care, Each party shall use at least the same degree of care to avoid inadvertent disclosure or unauthorized use of the other party’s Confidential Information which it employs with respect to it own proprietary or confidential
information which it does not wish to have disseminated, published or disclosed. 
 d) Inapplicability of Restrictions. There shall be no
restriction under this Agreement with respect to any portion of the Confidential Information which: 
  

	 	i)	is known to the recipient party or any affiliated company of the recipient party at the time of its disclosure to the recipient party; 

 

	 	ii)	is or becomes publicly known through no wrongful act of the recipient party or of any affiliated company of the recipient party; 

 

	 	iii)	is received from a third pasty without breach of the restrictions contained in this Agreement; 

 

	 	iv)	is independently developed by the recipient party or any affiliated company of the recipient party; 

 

	 	v)	is furnished to any third party by the disclosing party without a similar restriction on the recipient party’s rights; or 

 

	 	vi)	is approved for release by the disclosing party. 

e) Continuing applicability after Court ordered disclosure. When subject to any request, demand or order to disclose confidential information within the
context of any proceeding, the party subject to the request, demand or order shall immediately notify the disclosing party and shall take all reasonable steps to preserve the confidentiality of the information (such as seeking protective orders from
the court or governmental agency seeking the information, and submitting the required information under seal). Compulsory disclosure to a court or governmental agency shall not act to relieve the party subject to the compulsory disclosure from any
obligation to avoid disclosure. 
 10. REPRESENTATIONS 
 a) SMT represents and warrants to Adiana that: 
  

	 	i)	SMT is the owner of the entire right, title and interest in the Licensed Patents and it has no knowledge of any prior art patents or publications, or prior acts, that
would cause any claim of the Licensed Patents to be invalid or unenforceable. 

  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113726

  

					
		 	6	 	

	 	ii)	SMT is not aware of any other agreements or other express or implied obligations to third parties, which would conflict with or limit the License of the Patent or its
ability to perform its obligations hereunder. 

  

	 	iii)	SMT has no actual knowledge that Adiana’s proposed use of the inventions covered by the Patent to manufacture, use or sell Licensed Products will infringe any
patent or other restrictive right held by any third party. 

  

	 	iv)	SMT shall be deemed to be in possession of all knowledge held by Seare underlying all warranties and obligations expressed in this agreement. 

b) Each party represents and warrants to the other that: 
  

	 	i)	This Agreement constitutes a legal, valid and binding obligation of such party, enforceable in accordance with its terms, except as such enforcement may be limited by
bankruptcy, insolvency, reorganization or similar laws or equitable principles relating to or limiting the rights of creditors generally. 

  

	 	ii)	Such party is not a party to, bound by or subject to any agreement or instrument, or any judgment, order or decree of any court or governmental agency or authority,
which would be violated by such party’s entering into or carrying out this Agreement. 

  

	 	iii)	Such party is not a party to any pending, and does not know of any threatened, action, suit, proceeding or investigation in, before or by any court or governmental
agency or authority which may have an effect materially adverse to the other party in connection with this Agreement. 

 11. REGULATORY APPROVALS 
 Adiana intends to seek and shall be solely responsible for, all
regulatory approval from the United States Food and Drug Administration for its marketing in the United States of one or more Licensed Products. Adiana may also, in its discretion, seek foreign regulatory approval relating to the Licensed Products.
SMT agrees to use reasonable efforts, at Adiana’s expense, to support Adiana in its attempts to obtain such approvals and will reasonably cooperate and provide reasonable assistance, at Adiana’s expense, to Adiana with respect to any other
United States or foreign regulatory approvals sought by Adiana with respect to the Licensed Products. No assurance can be given that Adiana will obtain the approvals necessary to produce or market any Licensed Products in the United States or any
other country. 
 12. INDEMNIFICATION FOR PRODUCTS LIABILITY 
 Adiana shall indemnify SMT from any and all claims, demands, actions and causes of action against SMT for the death or bodily injury incurred by or rendered against SMT arising from the testing or use of
an Licensed Product by Adiana, provided that SMT shall give notice as soon as practical of any claims, demands, actions and causes of action against SMT for which Adiana may be obliged to indemnity SMT and that Adiana shall have the right to
participate in any compromise, settlement and defense thereof. This indemnification obligation shall include, without limiting the generality of the foregoing, reasonable attorneys’ fees and other costs or expenses incurred in connection with
the defense of any and all such claims, demands, actions, or causes of action, and shall extend to the trustees, officers, employees, and agents of SMT. 
  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113727

  

					
		 	7	 	

 13. TERM AND TERMINATION 
 a) Unless earlier terminated pursuant to this Agreement, the License shall terminate upon the expiration of the last expiring patent of the Licensed Patents. 

b) Adiana shall submit an application for marketing approval to FDA for a Licensed Product within five (5) years of the date of this Agreement. If
Adiana has failed to do so within the specified period, SMT may, in its sole discretion, terminate the License. 
 c) Adiana may terminate the
License at any time by giving thirty (30) days prior written notice of such termination to SMT. 
 d) If Adiana shall commit any material
breach of its obligations under this Agreement including non-payment of royalties and Adiana fails to remedy such breach within sixty (60) days after receipt of written notice SMT may, at SMT’s option, terminate the License by delivery of
written notice of such termination to Adiana. 
 e) Following the termination of this Agreement for any reason, Adiana and its sublicensees
shall be entitled to continue sales of Licensed Products previously produced by or for Adiana and its sublicensees under this Agreement until existing inventory is sold or for a period of six months, whichever occurs first. All such continued sales
shall carry an obligation that Adiana and its sublicensees shall owe and pay royalties, including minimum royalties, provide quarterly statements under Section 4, and comply with the other obligations Adiana has accepted under this Agreement.

 f) The confidentiality provisions of Section 9 shall survive termination of this Agreement. 

14. INFRINGEMENT CLAIMS                

 
 a) Notice of Third Party Infringement. SMT shall give prompt written notice to Adiana if, during the term of
the License, SMT becomes aware of any good made, used, sold offered for sale or imported into any country by another, not party to this Agreement, which infringes, or the use of which infringes, or possibly infringes the Licensed Patents.

 b) Infringement of Third Party Patents. In the event that Adiana becomes aware that the sale of a Licensed Product would, in the reasonable
opinion of Adiana’s patent counsel (a copy of which will be provided to SMT), infringe a valid patent right of a third party (excluding any Affiliate of Adiana), Adiana will first use reasonable efforts to redesign such Licensed Product to
avoid such infringement. If such redesign is impossible or unreasonable, and if the third party patent is not otherwise able to be avoided by having applicable claims found invalid or unenforceable and, in order to offer such Licensed Product in
commerce, Adiana is required to pay royalties to such third party (“Other Royalties”), the royalties payable by Adiana pursuant to Section 4 of this Agreement may be reduced by up to fifty percent (50%) to offset payments by
Adiana of Other Royalties, but in no event will the royalties payable by Adiana to SMT be reduced by more than fifty percent (50%) of the royalties otherwise due to SMT for such Licensed Product. 

c) Right to Defend. SMT shall give prompt written notice to Adiana if, during the term of the License, SMT becomes aware of any claim that any Licensed
Product infringes a valid patent of a third party, by reason of practicing one or more claims of a Licensed Patent. Adiana shall have the right, but not the obligation, to defend any suit brought by a third party for patent infringement, to bring a
declaratory judgment action or reach an agreement, at its expense, to defend against any claim of infringement; provided however, that SMT shall be fully apprised of all aspects of Adiana’s defense if Adiana wishes to 

 

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113728

  

					
		 	8	 	

 
assert any right to decreased royalties to SMT in the event of an adverse judgment coupled with Adiana taking a license from the third party in order to continue to practice the features of the
claims of the Licensed Patents involved in the infringement claim. If required by law and paid for by Adiana, Adiana may cause SMT to be joined as a party Plaintiff in such action, and SMT agrees to be so joined. In connection with any such suit,
employees of SMT and any affiliates shall execute all papers necessary or desirable, to effect formal requirements and shall testify, provide statements, or produce documents, whenever reasonably requested so to do by Adiana, although Adiana shall
reimburse SMT for all expenses related to activities requested by Adiana. Except for reimbursement of SMT’s direct expenses related to the suit, Adiana may retain any monies recovered in such action or in its settlement without payment or
reimbursement to SMT. SMT shall have the right to appear on its own behalf in any such suit, at its own expense. 
 15.
MISCELLANEOUS 
 a) Marking. Adiana agrees to affix or cause to be affixed proper statutory patent notices and markings to each Licensed
Product made, used or sold, offered for sale or imported by or for Adiana. 
 b) Entire Agreement. This Agreement contains the entire agreement
between the parties, and supersedes all prior agreements, representations and understandings of the parties, relating to the subject matter of this Agreement. 
 c) Further Actions. Each party agrees that after the delivery of this Agreement it will execute and deliver such further documents and do such further acts and things as the other party may reasonably
request in order to carry out the terms of this Agreement. 
 d) Amendments. No supplement or amendment of this Agreement will be binding unless
executed in writing by both the parties. 
 e) Waiver. Any term or provision of this Agreement may be waived at any time by the party entitled
to its benefit by a written instrument executed by a duly authorized officer of the party. No waiver of any of the provisions of this Agreement will be deemed, or will constitute, a waiver of any other provision, whether or not similar, nor will any
waiver constitute a continuing waiver. The failure of any party to enforce at any time any provision of this Agreement, or any right with respect thereto, or to exercise any election herein provided, shall in no way be considered to be a waiver of
such provision, right or election, or to in any way affect the validity of this Agreement. The exercise by any party of any right or election under the terms or covenants herein shall not preclude or prejudice any party from exercising the same or
any other right it may have under this Agreement, irrespective of any previous action or proceeding taken by the parties hereunder. 
 f)
Successors, Assigns and Sublicenses. This Agreement will be binding on, and will inure to the benefit of, the parties and their respective successors and assigns. Adiana may not assign the entire License without SMT’s written consent, which
shall not be unreasonably withheld, except that Adiana may make such an assignment by operation of law to any corporation with which it merges, to its Affiliate, to a purchaser of substantially all of its assets or to a successor to its business
interest relating to the Licensed Patents. Subject to Section 2(c) and provided that Adiana shall continue to be bound by its royalty and other obligations under this Agreement, Adiana shall be entitled to sublicense its rights under the
License to third parties, and to use independent contractors in the development, production and marketing of the Licensed Products. SMT agrees that his obligations under this Agreement will extend and be binding upon any party which acquires the
Licensed Patents or his related business or assets. 
  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113729

  

					
		 	9	 	

 g) Attorneys’ Fees. If any arbitration, legal action or other proceeding is brought in connection with
any of the provisions of this Agreement, the successful or prevailing party will be entitled to recover reasonable attorneys’ fees and other costs incurred in that arbitration, action or proceeding, in addition to any other relief to which that
party-may be entitled. 
 h) Governing Law. All questions with respect to the construction of this Agreement, and the rights and liabilities of
the parties under this Agreement, will be governed by the laws of the State of California, excluding conflicts of laws provisions. Venue for any non-arbitrable dispute or any relief not permitted in arbitration for disputes arising under this
contract shall be in United States District Court for the District of Northern California or appropriate courts of the State of California, County of San Mateo. 
 i) Arbitration. Any dispute arising between the parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, the performance by either party of its
obligations hereunder, whether before or after termination of this Agreement, shall be finally resolved by binding arbitration. Whenever a party shall decide to institute arbitration proceedings, it shall give notice to that effect to the other
parties. The party giving such notice shall refrain from instituting the arbitration proceeding for a period of sixty (60) days following such notice. Any arbitration hereunder shall be conducted in San Mateo County, California, under the
Commercial Arbitration Rules of the American Arbitration Association. Each such arbitration shall be conducted by a single arbitrator with the authority to grant specific performance, and to allocate between the parties the fees and expenses in such
equitable manner as they determine. Any monetary award shall bear interest at a rate fixed by the arbitrators from the date the arbitration proceeding is commenced to the date on which the award is paid in full. Judgment upon the award so rendered
may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. 
 j) Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed a valid, original agreement, but all of which together will constitute one and the same
instrument. 
 k) Severance. If any provision of this Agreement or its application to any person or circumstances is held to be unenforceable or
invalid by any court of competent jurisdiction, its other applications and the remaining provisions of this Agreement shall be enforced so as to best effect the intentions of the parties in entering into this Agreement. 

l) Captions. The section headings contained in this Agreement are for reference purposes only and shall not in any way affect the meaning or
interpretation of this Agreement. The references to sections refer to corresponding sections of this Agreement unless otherwise specified. 
 m)
Notices. Any notice or other communication to the parties pursuant to this Agreement shall be deemed to have been duly given and received on the date of actual delivery in writing, addressed to the President (or another officer designated below or
otherwise for such purpose) of the party, at its address set forth below. 
  

			
	If to SMT:	 	 William J. Seare, Jr., MD
 SM
Technologies LLC
 3190 Chula Vista Circle
 Salt Lake City, UT 84121

		
	If to Seare:	 	 William J. Seare, Jr., MD
 c/o
Seare Biomatrix Systems, Inc.
 3190 Chula Vista Circle
 Salt Lake City, UT 84121

  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113730

  

					
		 	10	 	

			
	If to Adiana:	 	Paul M. Goeld, President
		 	Adiana, Inc.
		 	2684 Middlefield Road, Suite A
		 	Redwood City, CA 94063

 Any party may change its address for purposes of this paragraph by giving the other parties written notice of the new
address in the manner set forth above. 
 n) Drafting. This Agreement has been negotiated at arm’s length and between persons sophisticated
and knowledgeable in the matters dealt with and represented by their own counsel. Accordingly, any rule of law (including California Code of Civil Procedure Section 1654) or legal decision that would require interpretation against the drafter
of this Agreement is not applicable and is waived. 
 o) Relationship of Parties. The relationships established between SMT and Adiana by this
Agreement are that of a licensor to its licensee, and nothing contained herein shall be deemed to establish or otherwise create a relationship of principal and agent or a partnership between them. Neither party nor any of its agents or other
distributors shall have any right or authority to assume or create any obligations of any kind, whether express or implied, on behalf of the other party. 
 p) Attribution. Adiana shall have the right to attribute technology used in Licensed Products to the Licensed Patents, including use of the name “Seare” and “William J, Seare, Jr., MD”
in packaging and promotional material for any Licensed Product. 
 16. SIGNATURES 

Executed as of the date first indicated above. 
  

					
	Adiana, Inc. (“Adiana”):	 	
			
	By:	 	         

	 	
		 	Paul M. Goeld, President	 	
		
	SM Technologies LLC (“SMT”):	 	
			
	By:	 	     

 Manager
	 	
		 	William J. Seare, Jr., Manager	 	
		 	 

	 	
		
	William J. Seare, Jr., MD (“Seare”):	 	
			
	By:	 	     

	 	
		 	William J. Seare, Jr., MD an Individual	 	

  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113731

  

					
		 	11	 	

 SM TECHNOLOGIES LLC 
 Date: 
 Company: Adiana / Cytyc 
 Fax Number: 508 263 2963. 
 Attention: Stephen Gordon 

Number of Pages, Including this Sheet: 2 

Comments: 
  

Here is SM Technologies W-9 Info. Depending when the check is sent, I may have you send it to a different address than the corporate address. That
address would be; 
 Dr. WJ Seare 
 7479 Mermaid Land 
 Carlsbad, CA 92011 

 

					
	 Thanks,

Dr. Seare
  
	 	

	 	

 825 North 300 West Suite
N-135                                Salt Lake City, Utah
84103-1459                                Cell (801) 580-0202 

  

					
	HIGHLY CONFIDENTIAL - OUTSIDE ATTORNEYS’ EYES ONLY	 	HOL-CON 0113732

 SCHEDULE D 

 

			
	 SIDLEY AUSTIN LLP
 M.
PATRICIA THAYER (SBN 90818)
 pthayer@sidley.com
 555 California Street, suite 2000
 San Francisco, CA 94104

Telephone:       415-772-1200
 Facsimile:        415-772-7400
  
 BRYAN K. ANDERSON (SBN 170666)
 bkanderson@sidley.com

AARON R. BLEHARSKI (SBN 240703)

ableharski@sidley.com
 1001 Page Mill Road,
Building 1
 Palo Alto, CA 94304

Telephone:       650-565-7000
 Facsimile:        650-565-7100
  
 NITIN REDDY (SBN 229451)
 nreddy@sidley.com

TASHICA T. WILLIAMS (SBN 256449)

ttwilliams@sidley.com
 555 West Fifth Street,
Suite 4000
 Los Angeles, CA 90013

Telephone:       213-896-6000
 Facsimile:        213-896-6600
  
 Attorneys for Plaintiff
 CONCEPTUS, INC.
	 	 ARNOLD & PORTER LLP

MATTHEW M. WOLF (pro hac vice)

matthew.wolf@aporter.com
 JOHN E. NILSSON (pro
hac vice)
 john.nilsson@aporter.com

SARA P. ZOGG (pro hac vice)

sara.zogg@aporter.com
 555 Twelfth Street,
NW
 Washington, DC 20004

Telephone:       202-942-5000
 Facsimile:        202-952-5999
  
 JENNIFER A. SKLENAR (SBN 200434)
 jennifer.sklenar@aporter.com

NICHOLAS H. LEE (SBN 259588)

nicholas.lee@aporter.com
 777 South Figueroa
Street, 44th Floor
 Los Angeles, CA 90071
 Telephone:       213-243-4000

Facsimile:        213-243-4199
  

MICHAEL A. BERTA (SBN 194650)

michael.berta@aporter.com
 One Embarcadero
Center, 22nd Floor
 San Francisco, CA 94111-3711
 Telephone:       415-356-3000

Facsimile:        415-356-3099
  

Attorneys for Defendant
 HOLOGIC,
INC.

 UNITED STATES DISTRICT COURT 
 NORTHERN DISTRICT OF CALIFORNIA 
 SAN FRANCISCO DIVISION 

 

			
	 CONCEPTUS, INC.,

 
 Plaintiff,

 
 v.

 
 HOLOGIC, INC.,

 
 Defendant.
	  	  
 Case No. 3:09-CV-2280-WHA

 
 JOINT MOTION TO ENTER
 INJUNCTION AND SET ASIDE AWARD
 OF DAMAGES, POST-JUDGMENT

INTEREST AND COSTS
  
 Hearing Date:    N/A

Time:                 N/A

Courtroom:        9, 19th Floor
 Judge:                Hon. William H. Alsup
  

  
  

JOINT MOTION TO ENTER INJUNCTION AND SET ASIDE AWARD OF DAMAGES, POST-JUDGMENT 

INTEREST AND COSTS 

CASE NO. 3:09-CV-2280-WHA 

 Conceptus, Inc. (“Conceptus”) and Hologic, Inc. (“Hologic”), by their
attorneys, advise the Court that they have settled their disputes in this action and in the related appeal, Conceptus, Inc. v. Hologic, Inc., Case Nos. 2012-1209, -1219 (Fed. Cir.). 

As part of the settlement, Hologic has advised Conceptus that the commercial performance and profitability of the Adiana system have
fallen short of Hologic’s expectations, and Hologic therefore consents to entry of a permanent injunction against it, barring it from directly or indirectly making, having made, offering for sale, selling, having sold, licensing, or otherwise
disposing of the Adiana system (or any products which are no more than colorably different from the Adiana system) in the United States, or importing the Adiana system (or any products which are no more than colorably different from the Adiana
system) into the United States, until expiration of U.S. Patent No. 6,634,361. The parties have further agreed that they shall jointly move to set aside the award of damages and post-judgment interest awarded in the Amended Judgment against
Hologic (Dkt. No. 536 (in the amount of $18,807,241.00 with post-judgment interest at the federal treasury rate from the date of the original judgment, October 18, 2011 to the date of satisfaction of the judgment)) and taxation of costs
against Hologic (Dkt. No. 538 (in the amount of $149,521.18)). The parties further agree that the non-monetary aspects of the Amended Judgment, including the referenced October 17, 2011 jury verdict on the issues of infringement and
validity, remains in force. The parties further agree that, subject to the conditions set forth in the parties’ License and Settlement Agreement, Conceptus waives any right to pursue payment from Hologic as to the amounts set forth in these
Orders. Conceptus also waives any right to pursue its claims – either in this action or by filing a supplemental complaint – for pre-judgment interest, supplemental pre-judgment damages, or supplemental post-judgment damages (Dkt. 532
(denying same)). 
 Accordingly, the parties request that the Court grant the requested relief, and enter an order enjoining
Hologic from directly or indirectly making, having made, offering for sale, selling, having sold, licensing, importing or otherwise disposing of the Adiana system (or any products which are no more than colorably different from the Adiana system) in
the United States and vacating the award of damages, post-judgment interest, and costs against Hologic. For the Court’s convenience, a proposed order is attached. 

 
  
 JOINT MOTION TO ENTER INJUNCTION AND SET ASIDE AWARD OF DAMAGES, POST-JUDGMENT 

INTEREST AND COSTS 

CASE NO. 3:09-CV-2280-WHA 

  
 -2-

							
		 		 		 	Respectfully submitted,
				
	Dated: April     , 2012	 		 	By:	 	  

		 		 		 	M. Patricia Thayer
		 		 		 	Counsel for Plaintiff Conceptus, Inc.
				
		 		 	By:	 	  

		 		 		 	Matthew M. Wolf
		 		 		 	Counsel for Defendant Hologic, Inc.

  
  

JOINT MOTION TO ENTER INJUNCTION AND SET ASIDE AWARD OF DAMAGES, POST-JUDGMENT 

INTEREST AND COSTS 

CASE NO. 3:09-CV-2280-WHA 

  
 -3-

 SIGNATURE ATTESTATION 

Pursuant to General Order No. 45(X)(B), I hereby certify that concurrence in the filing of this document has been obtained from each
of the signatories shown above. 
  

	
	   /s/

  
  

JOINT MOTION TO ENTER INJUNCTION AND SET ASIDE AWARD OF DAMAGES, POST-JUDGMENT 

INTEREST AND COSTS 

CASE NO. 3:09-CV-2280-WHA 

  
 -4-

 UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF CALIFORNIA 
  

			
	 CONCEPTUS, INC.,

 
 Plaintiff,

 
 v.

 
 HOLOGIC, INC.,

 
 Defendant.

 
	  	  
 Case No. 3:09-CV-2280-WHA

 
 [PROPOSED] ORDER ENTERING

PERMANENT INJUNCTION AND
 SETTING ASIDE
AWARD OF
 DAMAGES, POST-JUDGMENT
 INTEREST AND COSTS

 The Court, having considered the parties’ Joint Motion to Enter Injunction And Set Aside Award of
Damages, Post-Judgment Interest and Costs, and having been advised by the parties that they have settled their patent infringement dispute, hereby GRANTS the motion: 
 1) Hologic, directly or through any corporation, partnership, subsidiary, division, trade name, or other entity, and their officers, agents, servants, employees, and all persons and entities in active
concert or participation with them who has notice of this Order, is hereby permanently enjoined from directly or indirectly making, having made, offering for sale, selling, having sold, licensing, or otherwise disposing of the Adiana system (or any
products which are no more than colorably different from the Adiana system) in the United States, or importing the infringing Adiana system (or any products which are no more than colorably different from the Adiana system) into the United States,
until after expiration of U.S. Patent No. 6,634,361. 
 2) The damages and post-judgment interest awarded by the Amended
Judgment against Hologic, Dkt. No. 536, is set aside. The remainder of the Amended Judgment, including the referenced October 17, 2011 jury verdict on the issues of infringement and validity, remains in force. 

3) The taxation of costs against Hologic, Dkt. No. 538, is set aside. 

  
  

[PROPOSED] ORDER 

CASE NO. 3:09-CV-2280-WHA 

 4) Subject to the conditions set forth in the parties’ License and Settlement
Agreement, Conceptus shall not be entitled to seek from Hologic any pre-judgment interest, supplemental pre-judgment damages, or supplemental post-judgment damages, as set forth in Dkt. 532 denying the same. 

IT IS SO ORDERED. 
  

					
	Dated:                     , 2012	 		 	  

		 		 	UNITED STATES DISTRICT JUDGE

  
  

[PROPOSED] ORDER 

CASE NO. 3:09-CV-2280-WHA 

 IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 
  

					
	HOLOGIC, INC.,	 	)	 	
		 	)	 	
	 Plaintiff,
	 	)	 	
		 	)	 	Case No. 10-11355
	 v.
	 	)	 	
		 	)	 	
	CONCEPTUS, INC.,	 	)	 	
		 	)	 	
	 Defendant.
	 	)	 	
		 	)	 	

 JOINT MOTION TO REOPEN CASE FOR THE PURPOSE OF ENTERING A 

STIPULATED DISMISSAL AND FOR DISMISSAL OF CLAIMS WITH PREJUDICE 

Hologic, Inc. (“Hologic”) and Conceptus, Inc. (“Conceptus”), by their attorneys, respectfully move the Court to
reopen this case to enter a stipulated dismissal of Hologic’s claims against Conceptus. 
 On June 9, 2011, Conceptus
filed a motion to stay this action pending resolution of a patent infringement case that was then-pending between the parties, Case No. 09-cv-2280 (N.D. Cal.). (Dkt. 41.) The Court granted Conceptus’ motion (Dkt. Entry dated Jul. 5, 2011)
and entered an Order of Administrative Stay/Closing on July 7, 2011 “without prejudice to the right of any party to restore it to the active docket.” (Dkt. 44; see also Dkt. Entry dated Aug. 19, 2011 (case closed, “to be
reopened pending the resolution of the patent infringement action”).) Hologic and Conceptus have now settled their disputes in the California patent infringement action and a related appeal to the United States Court of Appeals to the Federal
Circuit, Case Nos. 2012-1209, -1219. The settlement agreement provides that they will jointly move to reopen this action in order to file a stipulated dismissal. A copy of the stipulation with a proposed order is attached hereto. 

 Accordingly, the parties respectfully requests that the Court grant their motion to reopen
Case No. 10-11355, and order that this action is dismissed with prejudice. 
  

							
		 		 		 	Respectfully submitted,
				
	Dated: April     , 2012	 		 	By:	 	  

		 		 		 	Joshua M. Dalton (BBO #636402)
		 		 		 	Scott T. Bluni (BBO #660187)
		 		 		 	Lawrence T. Stanley, Jr. (BBO #657381)
		 		 		 	BINGHAM MCCUTCHEN LLP
		 		 		 	One Federal Street
		 		 		 	Boston, MA 02110
		 		 		 	Telephone: (617) 951-8000
		 		 		 	Facsimile: (617) 951-8736
		 		 		 	josh.dalton@bingham.com
		 		 		 	scott.bluni@bingham.com
		 		 		 	lawrence.stanley@bingham.com
				
		 		 		 	Matthew M. Wolf
		 		 		 	Sara P. Zogg
		 		 		 	ARNOLD & PORTER LLP
		 		 		 	555 Twelfth Street, N.W.
		 		 		 	Washington, D.C. 20004
		 		 		 	Telephone: (202) 942-5000
		 		 		 	Facsimile: (202) 942-5999
		 		 		 	matthew.wolf@aporter.com
		 		 		 	sara.zogg@aporter.com
				
		 		 		 	Jennifer Sklenar
		 		 		 	ARNOLD & PORTER LLP
		 		 		 	777 South Figueroa Street, 44th Floor
		 		 		 	Los Angeles, CA 90071
		 		 		 	Telephone: (213) 243-4000
		 		 		 	Facsimile: (213) 243-4199
		 		 		 	jennifer.sklenar@aporter.com
				
		 		 		 	Counsel for Plaintiff Hologic, Inc.
				
		 		 	By:	 	  

		 		 		 	Mark S. Furman
		 		 		 	Emily C. Shanahan
		 		 		 	TARLOW, BREED, HART & RODGERS, P.C.
		 		 		 	101 Huntington Avenue

  
 2 

							
		 		 		 	Suite 500
		 		 		 	Boston, MA 02199
		 		 		 	Telephone: (617) 218-2058
		 		 		 	Facsimile: (617) 261-7673
		 		 		 	mfurman@tbhr-law.com
		 		 		 	eshanahan@tbhr-law.com
				
		 		 		 	Thomas P. Hanrahan
		 		 		 	SIDLEY AUSTIN LLP
		 		 		 	555 West Fifth Street
		 		 		 	Suite 4000
		 		 		 	Los Angeles, CA 90013
		 		 		 	Telephone: (213) 896-6000
		 		 		 	thanrahan@sidley.com
				
		 		 		 	Counsel for Defendant Conceptus, Inc.
				
		 		 	By:	 	  

		 		 		 	Barbara Healy Smith
		 		 		 	United States Attorney’s Office
		 		 		 	John Joseph Moakley Federal Courthouse
		 		 		 	1 Courthouse Way
		 		 		 	Suite 9200
		 		 		 	Boston, MA 02210
		 		 		 	Telephone: (617) 748-3100
		 		 		 	Facsimile: (617) 748-3969
				
		 		 		 	Counsel for Intervenor, U.S.A.

  
 3 

 IN THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 
  

					
	HOLOGIC, INC.,	 	)	 	
		 	)	 	
	 Plaintiff,
	 	)	 	
		 	)	 	Case No. 10-11355
	 v.
	 	)	 	
		 	)	 	
	CONCEPTUS, INC.,	 	)	 	
		 	)	 	
	 Defendant.
	 	)	 	
		 	)	 	

 STIPULATED DISMISSAL OF CLAIMS 

Hologic, Inc. (“Hologic”) and Conceptus, Inc. (“Conceptus”), by their attorneys, advise the Court that they have
settled their disputes in a patent infringement action, Conceptus, Inc. v. Hologic, Inc., Case No. 09-cv-2280 (N.D. Cal.), and related appeal, Conceptus, Inc. v. Hologic, Inc., Case Nos. 2012-1209, -1219 (Fed. Cir.). As part of
the parties’ settlement, Hologic has consented to voluntarily dismiss its claims against Conceptus in this action, with prejudice. 
  

							
	Dated: April     , 2012	 		 	By:	 	  

		 		 		 	Matthew M. Wolf
		 		 		 	Counsel for Plaintiff Hologic, Inc.
				
		 		 	By:	 	  

		 		 		 	Thomas P. Hanrahan
		 		 		 	Counsel for Defendant Conceptus, Inc.

 IT IS SO ORDERED. The Complaint and all claims which are or might have been asserted by Hologic against Conceptus
in this action are hereby dismissed with prejudice. 
  

							
	Dated:                     , 2012	 		 	By:	 	  

		 		 		 	UNITED STATES DISTRICT JUDGE

 Nos. 2012-1209, -1219 

 
  

UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT 

 
  

CONCEPTUS, INC., 
  

					
		 		 	Plaintiff-Cross Appellant,

 v. 
 HOLOGIC, INC., 
  

					
		 		 	Defendant-Appellant.

  
  

Appeals from the United States District Court for the Northern District of California 

in Case No. 09-CV-2280, Judge William H. Alsup. 
  

 
 JOINT MOTION TO DISMISS APPEALS

  

			
	Matthew M. Wolf	 	Eric A. Shumsky
	John E. Nilsson	 	Erika Myers
	Seth I. Heller 	 	SIDLEY AUSTIN LLP
	ARNOLD & PORTER LLP	 	1501 K Street N.W.
	555 Twelfth Street, N.W.	 	Washington, DC 20005
	Washington, DC 20004	 	Telephone: (202) 736-8496
	Telephone: (202) 942-5000	 	Facsimile: (202) 736-8711
	Facsimile: (202) 942-5999	 	Email: eshumsky@sidley.com
	Email: matthew.wolf@aporter.com	 	Email: erika.myers@sidley.com
	Email: john.nilsson@aporter.com	 	
	Email: seth.heller@aporter.com	 	Bryan K. Anderson
		 	Aaron Bleharski
	Jennifer A. Sklenar	 	SIDLEY AUSTIN LLP
	ARNOLD & PORTER LLP	 	1001 Page Mill Road, Suite 110
	777 South Figueroa Street, 44th Floor	 	Palo Alto, CA 94304
	Los Angeles, CA 90071	 	Telephone: (650) 565-8000
	Telephone: (213) 243-4000	 	Facsimile: (650) 565-7100
	Facsimile: (213) 243-4199	 	Email: bkanderson@sidley.com
	Email: jennifer.sklenar@aporter.com	 	Email: ableharski@sidley.com
		
	Counsel for Defendant-Appellant Hologic, Inc.	 	 M. Patricia Thayer

SIDLEY AUSTIN LLP

			
		 	555 California Street, Suite 2000
		 	San Francisco, CA 94104
		 	Telephone: (415) 773-4575
		 	Facsimile: (415) 773-5759
		 	Email: pthayer@sidley.com
		
		 	Nitin Reddy
		 	SIDLEY AUSTIN LLP
		 	555 West Fifth Street, 40th Floor
		 	Los Angeles, CA 90013
		 	Telephone: (213) 896-6000
		 	Facsimile: (213) 896-6600
		 	Email: nreddy@sidley.com
		
		 	Counsel for Plaintiff-Cross Appellant Conceptus, Inc.

 Dated: April     , 2012 

 Pursuant to Rule 27(b) of the Federal Rules of Appellate Procedure and Federal Circuit Rule
27(f), Defendant-Appellant Hologic, Inc. (“Hologic”) and Plaintiff-Cross Appellant Conceptus, Inc. (“Conceptus”) jointly move to dismiss their appeals and to remand to the United States District Court for the Northern District of
California for further proceedings pursuant to the parties’ settlement of their disputes in this case. The finalized settlement agreement provides that the parties shall jointly move to permanently enjoin Hologic from directly or indirectly
making, having made, offering for sale, selling, having sold, using, licensing, promoting, or distributing the Adiana system (or any products which are no more than colorably different from the Adiana system) in the United States, or importing the
Adiana system (or any products which are no more than colorably different from the Adiana system) into the United States, until after expiration of U.S. Patent No. 6,634,361, and to set aside the award of damages, post-judgment interest and
costs against Hologic and for other relief. 
 Accordingly, the parties respectfully request that their motion be granted, and
that this Court dismiss Case Nos. 2012-1209, -1219 with prejudice, and remand to the district court. 
  

							
		 		 		 	Respectfully submitted,
				
	April     , 2012	 		 	By:	 	  

		 		 		 	Matthew M. Wolf
		 		 		 	ARNOLD & PORTER LLP
				
		 		 		 	Counsel for Defendant-Appellant Hologic, Inc.
				
		 		 	By:	 	  

		 		 		 	Bryan K. Anderson
		 		 		 	SIDLEY AUSTIN LLP
				
		 		 		 	Counsel for Plaintiff-Cross Appellant Conceptus, Inc.

 SCHEDULE E 
 Regulatory Actions Permitted After Wind-Up of the Adiana Business 
  

	1.	Hologic may update its device listing to remove the Adiana Product from its listing information in accordance with 21 CFR § 807.30. 

 

	2.	Hologic may report and investigate adverse events of which it becomes aware with respect to already-implanted units of the Adiana Product in accordance with 21 CFR
§ 803 and other international regulatory agency regulations. 

  

	3.	Hologic may take corrective action(s) with respect to already-implanted units of the Adiana Product in accordance with 21 CFR § 806, to the extent applicable.

  

	4.	Hologic may perform any continued Quality System Regulation obligations in accordance with the applicable provisions of 21 CFR § 820 and other international
regulatory agency regulations. 

  

	5.	Hologic may perform any action with respect to the Adiana Product not otherwise listed on this Schedule E that is requested by the FDA or any other U.S. or
foreign governmental agency. 

  

	6.	Hologic may continue to conduct the mandatory FDA post-market study as required by the FDA.Manufacturing and Supply Agreement

 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. 

  
 1 

	 	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. 

  
 2 

	 	
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. 

  
 3 

	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. 

  
 4 

	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. 

  
 5 

	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. 

  
 6 

	 	
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 requested with respect to the omitted portions.

  
 7 

	 	
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.

  
 8 

	 	
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. 

 
 [***] 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. 

  
 9 

	 	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 requested with respect to the omitted portions. 

  
 10 

	 	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 

	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 

	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 

	 	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 

	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 

	 	(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 

	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 

 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 

 Appendix I: KorlymTM (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 

 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 

 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	  

  
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	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.

  
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	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.

  
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	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.

  
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	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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 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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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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 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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 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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	 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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	 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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	 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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