Document:

EXHIBIT 10.15

 

	
 
    	
[*]         Certain confidential information contained in this document, marked   by brackets, has been omitted and filed separately with the Securities and   Exchange Commission pursuant to Rule 406 of the Securities Act of 1933,   as amended.
    

 

PRODUCT DEVELOPMENT, COLLABORATION AND

 

LICENSE AGREEMENT

 

THIS PRODUCT DEVELOPMENT, COLLABORATION AND LICENSE AGREEMENT (the “Agreement”) is made as of May 11th, 2002 (the “Effective Date”), by and between Abrika LLLP, a Florida limited liability limited partnership (“Abrika”), with offices at 3320 Fairfield Lane, Weston, FL 33331, and Corium International, Inc., a Delaware corporation having a place of business at 2686 Middlefield Road, Suite G, Redwood City, CA 94063 (“Corium”; together with Abrika, the “Parties”).

 

BACKGROUND

 

WHEREAS, Corium is in the business of researching, developing, and manufacturing drug delivery systems for the purpose of delivering therapeutic substances across the human skin;

 

WHEREAS, Corium has represented that it has unique know-how in the fabrication and manufacture of transdermal fentanyl patches (“TDF patches”);

 

WHEREAS, Abrika wishes to engage Corium to commence a product development program, product registration and FDA approval for a TDF patch;

 

WHEREAS, Abrika wishes to obtain exclusive worldwide rights to make, use and sell TDF patches developed pursuant to this Agreement; and

 

WHEREAS, the Parties believe that it will be to their mutual advantage to enter into the arrangements hereinafter set out.

 

NOW, THEREFORE, in consideration of the foregoing recitals and of the covenants and other terms and conditions contained herein, the Parties agree as follows:

 

Article 1

 

Definitions

 

Terms used in this Article 1 and parenthetically elsewhere in this Agreement shall throughout this Agreement have the meanings here or there provided.  Defined terms may be used in the singular or in the plural, as the context shall require.

 

 

“Abrika Patents” means the patents and patent applications (and granted patents arising therefrom) owned by Abrika and listed in Schedule A hereto, including any divisions, continuations and continuations in part, extensions and renewals thereof and any supplementary or additional protection certificates related thereto.

 

“Affiliate” of a Party means a Person which is directly or indirectly controlled, controlled by, or under common control with, the Party.

 

“Corium Patents” means the patents and patent applications (and granted patents arising therefrom) owned by Corium and listed in Schedule B hereto, including any divisions, continuations and continuations in part, extensions and renewals thereof and any supplementary or additional protection certificates related thereto.

 

“Development Program” means the program of work agreed in writing between the Parties relating to the development of the Licensed Product, including milestones to be achieved, cost estimates, relevant time schedules, etc. for the Licensed Product, as supplemented and amended from time to time in accordance with the Agreement.  The Development Program is attached to this Agreement as Exhibit 1.

 

“Existing Technology” means all proprietary and confidential information, know-how, knowledge, experience, inventions, processes, technical information and data and materials protected by copyright, design right or rights in the nature of copyrights relating to the Field, which are owned or developed by Corium prior to the Effective Date.

 

“Field” means the delivery of fentanyl or other ultrapotent analgesic through transdermal patches or other methods of transdermal delivery.

 

“Jointly Developed IP” means any intellectual property rights (patentable and non-patentable) developed or generated by at least one employee of Abrika, on the one hand, and at least one employee of Corium, on the other hand, during the course of the Development Program and which are not already in the public domain.

 

“Licensed Product” means a formulation of TDF patches developed or generated as a result of the Development Program, including any subsequent modifications or variations thereof, or whose process of manufacture or use incorporates, or otherwise makes use of, the Abrika Patents, the Project Patents, the Jointly Developed IP or the Corium Patents.

 

“Net Sales Price” means the gross sales price or other monetary consideration received for a transfer for value of any Licensed Products, less bad debts related to the Product and sales returns and allowances, including but not limited to, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, recalls, returns, rebates chargeback rebates, fees, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions, freight and insurance charges billed to customers, custom or excise duties, sales tax and other taxes (except income taxes) or duties relating to sales, and any payment in respect of sales to any Governmental or Regulatory Authority in respect of any Federal or state Medicaid, Medicare or similar program, all as determined in accordance with generally accepted accounting principles.

 

“Non-Project IP” means the Non-Project Patents and the Non-Project Technology collectively.

 

“Non-Project Patents” means patents and patent applications (and granted patents arising therefrom) applicable or relating to the Field, which are developed by Corium independently of the Development Program, but excluding the Corium Patents.

 

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“Non-Project Technology” means any proprietary or confidential information, know-how, knowledge, experience, inventions, processes, technical information and data and materials protected by copyright, design right or rights in the nature of copyright relating to the Field, which are developed by Corium independently of the Development Program, but excluding the Existing Technology.

 

“Person” means an individual, partnership, corporation, trust, or unincorporated organization, and a government or agency or political subdivision thereof.

 

“Project IP” means Project Patents and Project Technology, collectively.

 

“Project Patents” means patents and patent applications (and granted patents arising therefrom) applicable or relating to the Field, which are developed by Corium solely as a direct result of any research and development activities performed under this Agreement.

 

“Project Team” means the Persons appointed by each Party to act as the liaison for that Party in all matters regarding the Development Program.

 

“Project Technology” means any proprietary or confidential information, know-how, knowledge, experience, inventions, processes, technical information and data and materials protected by copyright, design right or rights in the nature of copyrights relating to the Field, which are developed by Corium solely as a direct result of the research and development activities performed under this Agreement.

 

“Regulatory Authorities” means the U.S. Food and Drug Administration (“FDA”) and any other agency or authority primarily responsible for approval of pharmaceutical products in jurisdictions outside the U.S.

 

“Stage 1” means the series of tasks set forth in the Development Program, as set forth in Exhibit 1 hereto, as amended from time to time, relating to work performed prior to the filing of an abbreviated new drug application (“ANDA”) for the Licensed Product with the relevant Regulatory Authorities.

 

“Stage 2” means the series of tasks set forth in the Development Program set forth in the Development Program, as set forth in Exhibit 1 hereto, as amended from time to time, relating to the filing of, and all tasks performed during the pending status of, the ANDA for the Licensed Product.

 

“Stage 3” means the series of tasks set forth in the Development Program as set forth in Exhibit 1 hereto, as amended from time to time, occurring after the approval of an ANDA for the Licensed Product.

 

“Territory” means all of the countries throughout the world.

 

“Unaffiliated Person” means, with respect to a Party, a Person which is not an Affiliate of that Party.

 

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Article 2

 

Development and Production Activities

 

2.1                               Development Program.  The Parties shall design and implement a Development Program consistent with the provisions of this Section 2.1 and the applicable Exhibits attached hereto.

 

A.                                    Purpose.  The objective of the Development Program is to develop, successfully file, and have approved by the FDA or other Regulatory Authorities, a TDF patch which Corium would manufacture and supply to Abrika pursuant to the terms of a Supply Agreement as further referenced in Section 2.4 hereof

 

B.                                    Project Team.  Promptly following execution of this Agreement, the Parties shall establish a joint Project Team for the purpose of pursuing and managing the Development Program.  Each Party shall appoint to the Project Team one person to act as the liaison for that Party in all matters relating to the Development Program.  The Project Team shall meet as reasonably requested by either Party to discuss the progress of the Development Program, but not less frequently than on a monthly basis.  Meetings may be in person or via teleconference or videoconference.  Minutes shall be maintained for all Project Team meetings and shall be promptly approved by the Parties or shall be maintained in such other manner as the Parties may agree.

 

C.                                    Development Program.  Corium shall undertake all work in connection with the implementation of the Development Program (including specifically all tasks set forth in Stage 1, Stage 2 and Stage 3 hereto) in a workmanlike manner consistent with industry standards and in accordance with the following principles:

 

1.                                      Corium shall use its commercial best efforts to develop the Licensed Product to final form for supply to, and marketing and sale by, Abrika and its sublicensees, subject to scientific, clinical and regulatory milestones being met by the Parties as set forth in this Agreement and in the Development Program.

 

2.                                      Corium shall be responsible for formulation, research, and development, including product manufacture for clinical trials, and compilation of documentation in support of applicable regulatory filings with respect to its activities.

 

3.                                      Corium shall be responsible for clinical development (trial performance), and managing the regulatory approval process, including submission of documents to and communication with Regulatory Authorities and obtaining applicable approvals.

 

D.                                    Revisions to Development Program.  Each Party may propose and shall promptly communicate to the Project Team such revisions or modifications to the Development Program as it shall reasonably believe advance the best interests of the Parties, including such revisions or modifications that will improve the Parties’ prospects for the successful, expedient

 

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and efficient development of the Licensed Product.  The Parties shall work together diligently to develop a mutually acceptable revision of the Development Program, including the negotiation of an equitable sharing of any increased costs associated therewith, which costs shall only be deemed to constitute a part of a revised “Budget” (as defined in Section 2.3(A)) upon Abrika’s written consent.

 

2.2                               No Competitive Lines.  During the Term, unless the other party first agrees in writing, neither Corium nor Abrika shall sponsor, engage, be engaged, or participate in any research within the Field which will compete with the TDF patch.

 

2.3                               Responsibility for Costs and Development Charges. All costs incurred in connection with the development of the Licensed Product under the Development Program shall be borne by the Parties solely as provided in this Section 2.3.

 

A.                                    Development Budget.  The Development Program shall detail all estimated costs associated with each development task and milestone set forth therein (each such cost shall be referred to herein as an “Item” and all such costs shall, in aggregate, constitute the “Budget”).  All Items falling within Stage 1 tasks shall constitute the “Stage One Budget.”  All Items falling within Stage 2 tasks shall constitute the “Stage Two Budget.”  All Items falling within Stage 3 tasks shall constitute the “Stage Three Budget.”

 

B.                                    Stage 1 Costs.  Costs and expenses incurred in connection with the performance of the Items set forth in Stage 1 shall be shared equally between the Parties for so long as such costs and expenses are within the Stage One Budget.  Notwithstanding the foregoing, upon satisfaction of each of the conditions set forth in section 2.3(E), Corium shall be entitled to full reimbursement for all Stage 1 costs and expenses incurred.

 

C.                                    Stage 2 Costs and Stage 3 Costs.  Costs and expenses incurred in connection with the performance of the Items set forth in Stage 2 and Stage 3 shall be borne by Abrika for so long as such costs and expenses are within the Stage Two Budget and Stage Three Budget, respectively.

 

D.                                    Budget Overruns.  Costs and expenses exceeding the Stage One Budget shall be shared equally by the Parties, except that Corium shall bear full and sole responsibility for the cumulative costs and expenses that exceed [*] of the Stage One Budget.  Costs and expenses exceeding the Stage Two Budget and Stage Three Budget, respectively, shall be borne solely by Abrika, except that Corium shall bear full and sole responsibility for the cumulative costs and expenses that exceed [*] of the Stage Two Budget and Stage Three Budget, respectively.

 

E.                                     Procedure for Reimbursement.  Upon execution of this Agreement, Abrika shall pay to Corium [*] (the “Initial Stage 1 Payment”) to commence its obligations under the Development Program.  Corium may apply against the Initial Stage 1 Payment amounts to which it would be entitled to seek reimbursement.  Upon exhaustion of the Initial Stage 1 Payment, Corium shall submit to Abrika invoices on a monthly basis, which invoices shall be in such form as Abrika shall reasonably determine and shall provide sufficient detail such that Abrika may ascertain the nature of the work performed by Corium.  Abrika shall reimburse Corium within

 

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[*] following receipt of an invoice.  Notwithstanding anything to the contrary set forth in section 2.3(A), Corium shall be entitled to full reimbursement for all costs and expenses incurred in performing its obligations under Stage 1 (that are within the Stage One Budget) if, not later than fifteen months from the Effective Date, Corium shall have produced a prototype TDF patch that satisfies each of the following conditions (the “Prototype Conditions”):  (i) [*]; (ii) [*]; and (iii) [*].  Within [*] following Abrika’s reasonable determination that each of the Prototype Conditions have been met, Abrika will tender to Corium a check covering all Stage 1 costs and expenses reimbursable hereunder.

 

2.4                               Production of Licensed Product; Supply Agreement.  Promptly following the completion of Stage 1, Corium and Abrika will enter into good faith negotiations with respect to the execution of an agreement relating to and contemplating the manufacture and supply of the Licensed Product (the “Supply Agreement”).  The Supply Agreement will govern the Parties’ rights and obligations with respect to the manufacture and supply of sufficient commercial quantities of the Licensed Product and shall specifically include:  (i) an option for Corium to terminate the Supply Agreement, without further liability, upon [*]; and (ii) a requirement that Corium’s Cost of Goods Sold with regard to the manufacture and supply of the Licensed Product shall at all times be [*].  For so long as the Supply Agreement remains in effect, Corium shall be responsible for the production of the Licensed Product.  However, if the Parties fail to enter into the Supply Agreement, or upon termination of the Supply Agreement by Corium for any reason, Abrika shall have the right to enter into an agreement with a third party providing for such third party’s production of the Licensed Product, in which case Corium shall cooperate with Abrika to effect a complete and sufficient transfer and migration of any and all information, data, intellectual property or processes relevant to development or production of the Licensed Product to Abrika or its delegate, including without limitation any existing pre-clinical and clinical data (and shall convey physical possession thereof) as well as correspondence and data in connection with any submissions to Regulatory Authorities.

 

Article 3

 

Option on Non-Project IP

 

3.1                               Disclosure; Option.  Corium shall disclose to Abrika any Non-Project IP developed by Corium during the Term of this Agreement which it believes may be used or useful in the development and/or exploitation of other products in the Field, and Abrika shall have the right of first refusal to negotiate with Corium concerning a development program involving such Non-Project IP by giving written notice to that effect within [*] following receipt of disclosure from Corium.  The notice shall identify the Non-Project IP and the rights Abrika desires to obtain.  Upon receipt of the notice, the Parties shall negotiate in good faith an acceptable development program involving the Non-Project IP.

 

3.2                               Negotiation With Third Parties.  If (i) Abrika fails to give the notice referred to above, or (ii) the Parties fail, following good faith negotiations, to execute a letter of intent with respect to the Non-Project IP within [*] following such notice, Corium shall be free to exploit such Non-Project IP without regard to Abrika’s rights under Section 3.1, including without limitation, entering into agreements with one or more Persons to develop, manufacture or sell products covered by such Non-Project IP, but only outside the Field; provided, however, that

 

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Corium shall not, directly or through one or more Affiliates, enter into any such agreement with an Unaffiliated Person within the Field on royalty or fee terms less favorable to Corium than those contained in the last offer made to Corium during the negotiations referred to in this Article 3.

 

Notwithstanding the foregoing, if the development of the Licensed Products by the parties is prevented by existing intellectual property rights of one or more third parties, then Corium shall have the right to negotiate with one or more third parties concerning the development and/or exploitation of other products in the Field which may compete with the Licensed Products, provided that Abrika shall have a right of first refusal with respect to such development and/or exploitation.

 

Article 4

 

Grant of Rights

 

Subject to the terms and conditions of this Agreement, Corium, grants to Abrika, the following rights:

 

4.1                               The exclusive right and license to make, have made, use, market, distribute and sell the Licensed Product in the Territory.

 

4.2                               The exclusive right to use and practice the art covered by the Project Patents and the Jointly Developed IP, solely in connection with the rights set forth in Section 4.1.

 

4.3                               The exclusive right to use and to practice the art covered by the Project Technology under this Agreement solely in connection with the rights set forth in Section 4.1.

 

4.4                               The non-exclusive right to use and to practice the art covered by the Existing Technology and the Corium Patents solely in connection with the marketing and sale of the Licensed Products in the Territory within the Field.

 

4.5                               The right to sublicense any of the rights granted in Sections 4.1, 4.2, 4.3 and 4.4 hereof.

 

Article 5

 

Royalties on the Sale of Licensed Products

 

5.1                               Royalty Amounts.  Abrika shall pay to Corium the following royalties during the Term of this Agreement:        I

 

A.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Product in the United States so long as Corium is manufacturing and supplying the Licensed Product to Abrika pursuant to the terms of the Supply Agreement; or

 

B.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Product in the United States if:  (i) Corium is not manufacturing and supplying the Licensed

 

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Product to Abrika pursuant to the terms of the Supply Agreement, and (ii) Corium has developed Project IP which is being actively utilized in connection with the Licensed Product; or

 

C.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Product in the United States if:  (i) Corium is not manufacturing and supplying the Licensed Product to Abrika pursuant to the terms of the Supply Agreement, and (ii) Corium has not developed Project IP which is being actively utilized in connection with the Licensed Product.

 

D.                                    For all sales of the Licensed Product outside the United States, the Parties shall determine the amount of royalties to be paid to Corium on a case-by-case basis.  The Parties agree to negotiate in good faith to determine a value for such royalties which accurately reflects the contribution of each Party towards the realization of such sales of the Licensed Product.

 

5.2                               Time and Manner of Payment of Royalties.  Royalties due under Section 5.1 hereof shall be paid within [*] following the end of each calendar quarter (i.e., March 31, June 30, September 30, December 31) by check in United States dollars.  For purposes of computing royalties payable hereunder, amounts in currencies other than U.S. dollars shall be converted into U.S. dollars at the official exchange rate of that country on the last business day of the applicable quarter.

 

5.3                               Interest.  Any required royalty payments not made for any reason on or before the date for payment specified in Section 5.2 hereof shall bear interest from the date such royalty payment is due until the date it is received at [*].  The interest shall be calculated on a daily average basis.  Royalties placed on deposit at interest for the account of Corium pursuant to Section 5.2 shall be deemed paid for purposes of this Section as of the date of such deposit.

 

5.4                               Tax Withholding.  If Abrika shall be required by the laws of any jurisdiction to deduct or withhold from any payment to Corium any taxes or charges which may be levied against Corium, Abrika may deduct or withhold such taxes or charges in accordance with applicable law.

 

Article 6

 

Reports and Audit

 

6.1                               Periodic Reports.  Abrika shall deliver to Corium, simultaneously with the payment of royalties due hereunder, a written report reflecting the aggregate Net Sales Price for all Licensed Product sold during the applicable quarter in such form as Abrika shall in its sole discretion shall determine.  If no royalties are due for the quarter, the report shall so state.

 

6.2                               Delivery of Final Report.  Abrika shall deliver to Corium a final written report within [*] after the date of termination of this Agreement detailing sales or other dispositions of the Licensed Product upon which royalty payments are payable to Corium.  Concurrent with the making of such written report, Abrika shall pay to Corium the balance of all royalties due and payable to Corium.

 

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Article 7

 

Termination of Exclusivity

 

7.1                               Termination.  If Abrika shall have failed to commercially launch the Licensed Product, either directly or indirectly through a third party, for sale in any country in the Territory (other than the United States) at any time following the [*] anniversary of the date after which such country granted Abrika the regulatory approval necessary to commence commercial sale, then Abrika’s exclusive rights under section 4 in such country shall terminate (“Exclusivity Termination”) and such right shall continue thereafter on a non-exclusive basis, and Corium shall, subject to the consent of any Regulatory Authorities or other third parties, enjoy the same commercial exploitation rights as Abrika in such country with respect to the Licensed Product, including the right to grant sublicenses with respect to the Licensed Product.

 

7.2                               Notice; Exception.  The termination of Abrika’ exclusive rights under Section 7.1 shall take effect thirty (30) days following its receipt of written notice from Corium (the “Exclusivity Notice Period”) indicating its intent to exercise its rights thereunder.  Notwithstanding the foregoing, Exclusivity Termination shall not apply in the event that Abrika provides notice to Corium within the Exclusivity Notice Period that its failure to commence commercial sale or distribution is due to causes beyond its control, and that such causes are not likely to continue beyond the twelve month period of such notice.

 

Article 8

 

Ownership of Intellectual Property

 

8.1                               Ownership by Corium.  All Corium Patents, Existing Technology, Project IP and Non-Project IP shall belong to and, to the extent necessary to transfer or perfect ownership rights therein, be assigned to Corium, and Corium shall have exclusive right, title and interest thereto, subject to the license rights granted to Abrika hereunder.

 

8.2                               Ownership of Abrika Patents.  Abrika shall have exclusive right, title, and interest in the Abrika Patents, except that the Corium shall have the right to conduct research, development and other activities with respect to the Abrika Patents to the extent they are the subject of the Development Program.

 

8.3                               Ownership of Jointly Developed IP.   Any Jointly Developed IP shall belong to and, to the extent necessary to transfer or perfect ownership rights therein, be assigned to Abrika and Corium as joint owners.

 

8.4                               Use of Jointly Developed IP.  Abrika and its affiliates shall have the full right to use and exploit any Jointly Developed IP within the Field, as set forth in this Agreement.  Corium shall have no right to use or exploit any Jointly Developed IP for any purpose within the Field except as contemplated by the Development Program.

 

8.5                               Use of Licensed Product Trademarks.  All trademarks, whether registered or unregistered, associated with the Licensed Product shall be owned by Abrika and, to the extent necessary to transfer or perfect ownership rights therein, shall be assigned to Abrika, and Abrika

 

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shall have exclusive right, title and interest thereto.  All goodwill associated with any trademark hereunder shall inure to the sole and exclusive benefit of Abrika

 

8.6                               Employee Agreements.  Each Party agrees that it shall obtain from its officers, employees and consultants, duly binding agreements by such persons to:  (i) disclose and, to the extent necessary, to transfer all Jointly Developed IP and Project IP to such Party; and (ii) perfect ownership of all Jointly Developed IP and Project IP rights in such Party.

 

Article 9

 

Representations and Disclaimer

 

9.1                               Representations by Abrika.  Abrika represents and warrants to that:

 

A.                                    It has the full legal right, power, and authority to enter into Agreement.

 

B.                                    This Agreement is a legal and valid obligation of Abrika, and the execution, delivery and performance of this Agreement by Abrika does not and will not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body administrative or other agency having authority over it.

 

9.2                               Representations by Corium.  Corium represents and warrants to Abrika that:

 

A.                                    It has the full legal right, power, and authority to enter into this Agreement.

 

B.                                    This Agreement is a legal and valid obligation of Corium, and the execution, delivery and performance of this Agreement by it does not and will not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body, administrative or other agency having authority over it.

 

C.                                    To the best knowledge of Corium, the Corium Patents and the Existing Technology do not infringe any valid right of any Person.

 

Article 10

 

Limitation of Liability

 

IN NO EVENT SHALL ABRIKA OR ANY AFFILIATE OF ABRIKA BE LIABLE TO CORIUM FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES UNDER THIS AGREEMENT OR OTHERWISE, REGARDLESS OF WHETHER ABRIKA OR CORIUM KNEW OR HAD REASON TO KNOW OF THE POSSIBILITY OF SUCH DAMAGES.

 

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Article 11

 

Indemnification and Insurance

 

11.1                        Indemnification.  Corium shall defend, indemnify and hold Abrika, its Affiliates and each officer, director, employee or agent thereof (collectively, the “Indemnitees”) harmless from and against any damages, liabilities, losses, costs and expenses, including reasonable attorneys’ fees and court costs, incurred by the Indemnitees as a result of any claim, lawsuit, action or proceeding (collectively, “Losses”) attributable to, relating to or arising out of any claim (a “Claim”) (i) that the Licensed Product violates the intellectual property rights of any third party or (ii) that Corium is in material breach of any of its representations under this Agreement.  Abrika shall notify Corium promptly following Abrika’s learning of any Claim and shall allow Corium, at Corium’s expense, to assume defense of such Claim.  Corium shall have the exclusive right to defend, contest, litigate, or settle any matter with respect to which indemnification is claimed under this Article.  For the purposes of this Section 11.1, the term “Claim” shall be limited to claims of violations or breaches alleged to have occurred within the United States.  The indemnification obligations of Corium under this Section 11.1 shall survive termination of this Agreement.

 

11.2                        Insurance.  Prior to the first commercial sale of any Licensed Product, and for a period of [*] after the termination of this Agreement, Corium shall obtain and/or maintain, at its sole cost and expense, product liability insurance in amounts, which are reasonable and customary in the U.S. pharmaceutical industry for companies which are of a similar size to Corium, subject always to a minimum limit of [*] per occurrence (or claim) and in the aggregate annually.  Such product liability insurance shall insure against all liability, including product liability, personal liability, physical injury, or property damage.  Corium shall provide written proof of the existence of such insurance to Abrika upon request.

 

Article 12

 

Confidentiality

 

12.1                        Disclosure of Confidential Information.  In carrying out its obligations contemplated by this Agreement, each Party (the “Disclosing Party”) may from time to time during the Term of this Agreement disclose to the other Party (the “Receiving Party”) certain information regarding the Disclosing Party’s business, including information concerning medical or pharmaceutical matters, delivery mechanisms, personnel, technical, marketing, financial, employees, planning, and other confidential or proprietary information (“Confidential Information”).  “Confidential Information” shall also include the substantive terms and the existence of this Agreement.  The Disclosing Party will mark all Confidential Information in tangible form as “confidential” or “proprietary” or with a similar legend.  The Disclosing Party will identify all Confidential Information disclosed orally as confidential at the time of disclosure and provide a written summary of such Confidential Information to the Receiving Party within thirty (30) days after such oral disclosure.  Regardless of whether so marked or identified, however, any information that the Receiving Party knew or should have known, under the circumstances, was considered confidential or proprietary by the Disclosing Party, will be considered Confidential Information of the Disclosing.

 

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12.2                        Protection of Confidential Information.  The Receiving Party will not use any Confidential Information of the Disclosing Party for any purpose not expressly permitted by this Agreement, and will disclose the Confidential Information of the Disclosing Party only to those employees or contractors of the Receiving Party who have a need to know such Confidential Information for purposes of this Agreement and who are under a duty of confidentiality no less restrictive than the Receiving Party’s duty hereunder.  The Receiving Party will protect the Disclosing Party’s Confidential Information from unauthorized use, access, or disclosure in the same manner as the Receiving Party protects its own confidential or proprietary information of a similar nature and with no less than reasonable care.

 

12.3                        Return of Confidential Information.  The Receiving Party will return to the Disclosing Party or destroy all Confidential Information of the Disclosing Party in the Receiving Party’s possession or control promptly upon the written request of the Disclosing Party on the earlier of the expiration or termination of this Agreement.  At the Disclosing Party’s request, the Receiving Party will certify in writing that it has fully complied with its obligations under this Article 12.

 

12.4                        Injunctive Relief; Damages.  The Parties agree that breaches of the confidentiality provisions herein will cause the non-breaching Party to suffer irreparable harm and be without an adequate remedy at law, and that the non- breaching Party shall be entitled to injunctive or equitable relief (without being required to post any bond or other security) from a court of competent jurisdiction in order to prevent, prohibit or restrain any such breach or violation.  Resort by a Party to injunctive or other equitable relief shall not be deemed a waiver of such Party’s other rights or remedies under the terms of this Agreement or otherwise.

 

12.5                        Exceptions.  The Receiving Party’s obligations hereunder with respect to any Confidential Information of the Disclosing Party will terminate if and when the Receiving Party can document that such information:  (a) was already known to the Receiving Party at the time of disclosure by the Disclosing Party; (b) was disclosed to the Receiving Party by a third party who had the right to make such disclosure without any confidentiality restrictions; (c) is or through no fault of the Receiving Party has become, generally available to the public; (d) is independently developed by the Receiving Party without access to, or use of, the Disclosing Party’s Confidential Information; or (e) is required by law or by the order of a court or similar judicial or administrative body, provided that the Receiving Party notifies the Disclosing Party of such required disclosure promptly and in writing and cooperates with the Disclosing Party, at the Disclosing Party’s reasonable request and expense, in any lawful action to contest or limit the scope of such required disclosure.

 

Article 13

 

Term and Termination; Default

 

13.1                        Term.  The term of this Agreement (“Term”) shall commence on the Effective Date, and, unless terminated earlier in accordance with other provisions of this Agreement, shall continue until Abrika shall fail to:  i) commence commercial distribution within six months after the latter of:  x) ANDA approval of the Licensed Product, or y) expiration or resolution of any regulatory bar, patent conflict, other third party conflict or related issues that were beyond the 

 

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control of Abrika; or ii) make the Licensed Product available for commercial distribution, for a period of six consecutive months, after initial commercial distribution is commenced.

 

13.2                        Termination.  This Agreement may be terminated as follows:

 

A.                                    By mutual written consent of both Parties at any time.

 

B.                                    By Abrika at any time prior to the first commercial sale of the Licensed Product upon at least [*] prior written notice to Corium.

 

C.                                    By Abrika at any time following the first commercial sale of the Licensed Product upon at least [*]prior written notice to Corium.

 

D.                                    By Abrika at any time if Corium’s Cost of Goods Sold with regard to the manufacture and supply of the Licensed Product is equal to or greater than twenty percent (20%) of the Net Sales Price received by Abrika for the sale of such Licensed Product, as set forth in Section 2.4 hereof.

 

E.                                     By Abrika at any time after Adrian Faasse ceases to serve as either Chairman or Chief Operating Officer of Corium.

 

F.                                      By Abrika or Corium, upon written notice to the other (i) in the event of a breach or default by the other Party in the due observance or performance of any covenant, condition or limitation of this Agreement, but only if the defaulting Party shall not have cured its default (if such default is subject to cure) within 30 days after receipt of written notice of such default from the non-defaulting Party, or (ii) if the other Party is adjudicated as bankrupt, if insolvency, bankruptcy, reorganization, debt adjustment or liquidation proceedings are instituted against such Party and not dismissed within 60 days after the institution thereof, if a receiver or trustee is appointed for such Party and its assets, or if such Party makes a general assignment for the benefit of its creditors.

 

13.3                        Consequences of Termination.  Upon termination of this Agreement, all licenses set forth in Article 4 shall terminate; provided, however, that all licenses set forth in Article 4 shall continue if this Agreement is terminated by Abrika pursuant to Section 13.2(F).  In such event, Corium covenants to cooperate with Abrika to effect a complete and sufficient transfer and migration of any and all information, data, or processes relevant to development or production of the Licensed Product to Abrika or its delegate, including without limitation any existing pre-clinical and clinical data (and shall convey physical possession thereof) as well as correspondence and data in connection with any submissions to Regulatory Authorities.

 

Article 14

 

Survival

 

Notwithstanding anything to the contrary in this Agreement, Articles 8, 10, 11, 12, and 13 shall survive termination of this Agreement.

 

Article 15

 

Right of First Refusal

 

During the Term of this Agreement, Corium shall not enter into any Business Combination without first tendering to Abrika a written offer to enter into a similar transaction with Corium on substantially the same terms and conditions as those proposed by or to the third party.  A Business Combination shall mean (a) a merger, consolidation, acquisition, scheme or other analogous arrangement in which Corium shall not be the surviving entity (b) a sale of all or substantially all of the assets of Corium (c) a contractual business relationship (whether characterized as, or evidenced by, any license agreement, alliance agreement, joint venture or other partnering relationship) relating to the development, use or exploitation of any fentanyl or other ultrapotent analgesic product; or (d) the issuance by Corium of any of its equity securities, or such other securities or rights that are convertible or exchangeable into equity securities.  Upon receipt of a written offer from Corium setting forth the details of a proposed Business Combination, Abrika shall have [*] to provide Corium with a written response setting forth Abrika’s decision regarding its right of first refusal with respect to such Business Combination.  Abrika’s failure to deliver a written response within the [*] response period shall be deemed to be a waiver of its right of first refusal with respect to such Business Combination, but not with respect to any future Business Combinations.

 

*Confidential Treatment Requested.

 

13

 

Article 16

 

Stock Purchase Option

 

In consideration of Abrika’s entering into this Agreement and funding of the development of the TDF patch, Corium and Abrika shall enter into a Stock Purchase Agreement pursuant to which Corium shall grant to Abrika, for [*] and other good and valuable consideration, a number of shares of Corium’s Common Stock (the “Shares”), which number shall be equal, at the time of grant, to [*] of the issued and outstanding Common Stock of Corium, and which Shares shall be subject to customary anti-dilution protection.  The Stock Purchase Agreement shall provide for Abrika to receive the Shares at least [*] prior to the earliest of:  (i) any initial public offering of the Common Stock of Corium, or (ii) any sale of all, or substantially all, of the assets or Common Stock of Corium, or (iii) any merger, consolidation or other reorganization which results in a change in control of Corium or in which Corium is not the surviving entity.

 

Article 17

 

Miscellaneous

 

17.1                        Notices.  Any notice required to be given under this Agreement shall be in writing in English and shall be deemed duly given if signed by or on behalf of a duly authorized officer of the Party giving the notice, and if left at, or sent by registered or recorded delivery post or by facsimile transmission to:

 

	
Corium:
    	
Corium international, Inc.
    
	
 
    	
2686 Middlefield Road, Suite G
    
	
 
    	
Redwood City, California 94063
    
	
 
    	
Attention: Adrian Faasse
    
	
 
    	
FAX: (650) 298-8012
    
	
 
    	
 
    
	
with a copy to:
    	
 
    
	
 
    	
 
    
	
 
    	
Attention:
    
	
 
    	
FAX:
    
	
 
    	
 
    
	
Abrika:
    	
Abrika LLLP
    
	
 
    	
c/o National Car Rental Center
    
	
 
    	
2555 Panther Parkway
    
	
 
    	
Sunrise, Florida 33323
    
	
 
    	
Attention: James New
    
	
 
    	
FAX: (954) 835-8088
    
	
 
    	
 
    
	
with a copy to:
    	
Holland & Knight LLP
    
	
 
    	
200 South Orange Avenue, Suite 2600
    
	
 
    	
Orlando, Florida 32801
    
	
 
    	
Attention: Louis T. M. Conti, Esq.
    
	
 
    	
FAX: (407) 244-5288
    

 

or at such other address as either Party may direct the other in writing.

 

*Confidential Treatment Requested.

 

14

 

Any such notice or other communications shall be deemed to be given:  at the time when the same is handed or left at the address of the Party to be served; by post on the day (not being a Sunday or public holiday) five days following the day of posting; and in the case of a facsimile transmission, on the next following day, provided that a confirming copy of it is sent by registered or recorded delivery post to the other Party at the address given in this Agreement within 24 hours after the transmission.

 

17.2                        Headings.  The headings preceding the text of the Articles and Sections of this Agreement are inserted solely for convenience of reference, and do not constitute a part of this Agreement or affect its meaning, construction, or effect.

 

17.3                        Integration.  This Agreement and the Supply Agreement negotiated hereafter, set forth the entire agreement between the Parties with respect to the subject matter hereof, and supersede all prior agreements and understandings with respect to such subject matter.

 

17.4                        Waiver.  No consent by any Party to or waiver of a breach or default by the other, whether express or implied, shall constitute a consent to, waiver of, or excuse for any difference or subsequent breach or default.  All waivers hereunder must be signed by the Party against which such waiver is asserted.

 

17.5                        Counterparts.  This Agreement may be executed in multiple counterparts, and each counterpart shall be deemed an original of this Agreement.

 

17.6                        Governing Law.  The validity and interpretation of this Agreement shall be governed and construed in accordance with the United States patent laws and the laws of the State of Florida without regard to the conflicts of laws principles thereof.

 

17.7                        Unenforceability of Provision(s).  Unenforceability of any provision or provisions hereof shall not render unenforceable, or impair, the remainder thereof.  If any provision or provisions of this Agreement shall be deemed invalid, illegal or unenforceable, either in whole or in part, this Agreement shall be deemed amended to delete or modify as necessary the offending provision or provisions and to alter the bounds thereof in order to render it valid and enforceable.

 

[Remainder of page intentionally left blank.]

 

*Confidential Treatment Requested.

 

15

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first written above.

 

	
 
    	
CORIUM INTERNATIONAL, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Adrian Faasse
    
	
 
    	
Name:
    	
Adrian   Faasse
    
	
 
    	
Title:
    	
CEO
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
ABRIKA LLLP
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   James S. New
    
	
 
    	
Name:
    	
James   S. New
    
	
 
    	
Title:
    	
PARTNER
    

 

 

SCHEDULE A

 

ABRIKA PATENTS

 

[*]

 

*Confidential Treatment Requested.

 

 

SCHEDULE B

 

CORIUM PATENTS

 

[*]

 

*Confidential Treatment Requested.

 

 

EXHIBIT 1

 

DEVELOPMENT PROGRAM

 

Stage 1 - Pre-ANDA Budget (Prototype Development)

 

	
Budget Items
    	
 
    	
Budget
    
	
Development by Corium Technology Group
    	
 
    	
[*]
    
	
Development Supplies
    	
 
    	
[*]
    
	
DEA Consultant
    	
 
    	
[*]
    
	
Facilities Modifications
    	
 
    	
[*]
    
	
Capital Equipment
    	
 
    	
[*]
    
	
Total
    	
 
    	
[*]
    

 

Stage 2 - ANDA Filing Budget

 

	
Budget Items
    	
 
    	
Budget
    
	
Materials For Process Scale Up And   Bio-Equivalent Lot Manufacturing
    	
 
    	
[*]
    
	
Process Scale Up And Bio-Equivalent Lot   Manufacturing
    	
 
    	
[*]
    
	
Regulatory Costs
    	
 
    	
[*]
    
	
Total
    	
 
    	
[*]
    

 

Stage 3 - Post-ANDA Filing Budget

 

	
Budget Items
    	
 
    	
Budget
    
	
Development By Corium Technology Group
    	
 
    	
[*]
    
	
Capital Equipment
    	
 
    	
[*]
    
	
Manufacturing Scale Up
    	
 
    	
[*]
    
	
Total
    	
 
    	
[*]
    

 

*Confidential Treatment Requested.

 

1

 

Budget Summary for Stages 1-3

 

	
Budget Items
    	
 
    	
Budget
    
	
Pre-ANDA Budget
    	
 
    	
[*]
    
	
ANDA Filing Budget
    	
 
    	
[*]
    
	
Post-ANDA Filing Budget
    	
 
    	
[*]
    
	
Total
    	
 
    	
[*]
    

 

*Confidential Treatment Requested.

 

2

 

EXHIBIT 1 (CONT.)

 

TIMELINE AND ACTIONS FOR EXECUTION OF
 PRODUCT DEVELOPMENT PROGRAM

 

[*]

 

*Confidential Treatment Requested.

 

3

 

Amendment to
 The Product Development, Collaboration and License
 Agreement

 

This Amendment to the Product Development, Collaboration and License Agreement for Transdermal Fentanyl is made as of November 12th, 2003 ( the “Effective Date”), by and between Abrika LLLP, a Florida limited liability limited partnership (“Abrika’), with offices at 13800 N.W. 2nd St., Suite 190, Florida 33325 and Corium International, Inc., a Delaware corporation having a place of business at 2686 Middlefield Road, Suite G, Redwood City, CA 94063 ( “Corium; together with Abrika, the “Parties”).

 

RECITALS

 

1.             The Parties have previously entered into a “Product Development, Collaboration and License Agreement” dated May 11, 2002 under which the Parties agreed to collaborate with respect to transdermal fentanyl patches.

 

2.             The Parties have also entered into a “ Manufacturing and Supply Agreement for Transdermal Fentanyl” dated November 12th, 2003.

 

3.             The Parties now wish to make certain Amendments to the “Product Development, Collaboration and License Agreement” to reflect mutually agreed to changes in the terms and conditions of this agreement.

 

NOW, THEREFORE, inconsideration of the foregoing recitals, it is agreed between the Parties as follows:

 

1.              The current wording of Article 15 in the Product Development, Collaboration and License Agreement will be eliminated and replaced with a new Article 15 whose wording will substitute in total for the original wording of Article 15. The new Article 15 entitled Notification Requirement now reads as follows:

 

If a third party independently or in concert with others commences or makes an Acquisition Proposal, and such third party is the acquiring party, or if Corium solicits a third party offer for an Acquisition Proposal or Business Combination, and such third party is the acquiring party, then Corium shall have as a requirement to notify Abrika within 48 hours of having received an Acquisition or Business Combination Proposal from the third party. A Business Combination or Acquisition Proposal shall mean (a) Any tender offer or exchange offer or proposal to Corium or involving the purchase of 20% or more of the outstanding voting securities of Corium; (b) a merger, consolidation, acquisition, scheme or analogous arrangement in which Corium shall not be the surviving entity; (c) a sale of all or subsequently all of the assets of Corium; (d) a contractual business relationship ( whether characterized as, or evidenced by, any license agreement, alliance agreement, joint venture or other

 

1

 

partnering relationship) relating to the development, use or exploitation of any fentanyl or other ultrapotent analgesic product.

 

2.              Article 16 Stock Purchase Option - will also be redacted to read as follows:

 

In consideration of Abrika’s entering into this Agreement and funding of the development of the TDF patch, Corium and Abrika shall enter into a Stock Purchase Agreement pursuant to which Corium shall grant to Abrika, for $1.00 and other good and valuable consideration, a number of shares of Corium’s Common Stock ( the Shares”) which number shall be equal, at the time of grant, to five percent (5% ) of the issued and outstanding Common Stock of Corium. This transfer of shares from Corium to Abrika shall occur no later than 45 days after the consummation of this Amendment Agreement.

 

Abrika will have the option to participate in the purchase of additional shares of Corium should these shares be offered for sale at any time prior to Corium becoming a public company. Corium will be required to notify Abrika of any future financing rounds involving the sale of Corium common or preferred shares, so that Abrika at its own election may choose to purchase additional shares in order to at least maintain its 5% equity position in Corium.

 

3.              New Article 18 entitled Regulatory Matters — Legal ownership of the Abbreviated New Drug Application (ANDA) for TD fentanyl will transfer from Corium to Abrika, as part of this Amendment Agreement to the Product Development, Collaboration and License Agreement:

 

(a.)            Ownership. All regulatory approvals within the Territory relating to TD fentanyl shall he deemed the property of Abrika or Abrika’s designated licensees, and held, to the extent legally permissible, in Abrika’s or its Affiliates’ name, or in the name of Abrika’s designated licensees.

 

(b.)            Final Authority. Abrika shall have final authority for all matters relating to the nature and content of the ANDA for TD fentanyl, or other regulatory filings submitted to the FDA or other governmental authority directly involved with the review and final marketing approval of the TD fentanyl product unless Abrika has delegated this responsibility to its licensees in particular territories.

 

(c.)             Abrika, or its designated licensees, shall have the sole responsibility for communicating with FDA and other regulatory authorities about the Product, provided that Abrika shall provide Corium with a reasonable opportunity to review and comment upon all TD fentanyl regulatory filings.

 

(d.)            Corium shall not without the consent of Abrika or unless so required by Law, correspond or communicate with the FDA, or with any other Governmental or Regulatory Authority, whether within the Territory or otherwise, concerning TD fentanyl. If Corium is advised by its legal 

 

2

 

counsel that it must communicate with the FDA, or with any other Governmental of Regulatory Authority, then Corium will advise Abrika immediately and, unless the Law prohibits, provide Abrika in advance with a copy of any proposed written communication with the FDA or any other Governmental or Regulatory Authority and will comply with any and all reasonable direction of Abrika concerning any meeting or written or oral communication with the FDA or any other Governmental or Regulatory Authority.

 

4.              Modification to the definition of “Field”. A new definition for Field will replace the former definition for Field in the Product Development, Collaboration and License Agreement, and will read as follows: “Field” means the delivery of fentanyl through transdermal patches or other methods of fentanyl transdermal delivery.

 

IN WITNESS WHEREOF, the Parties are in agreement to these proposed changes in the Product Development, Collaboration, and Licensing Agreement, which are captured in this Amendment Agreement, then such agreement is attested to by the signature of Parties below on the date indicated.

 

 

	
 
    	
Corium   International. Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/   Adrian L. Faasse
    
	
 
    	
Name:
    	
Adrian   L. Faasse
    
	
 
    	
Title:
    	
CEO
    
	
 
    	
Date:
    	
11/12/03
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Abrika   LLLP
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   James New
    
	
 
    	
Name:
    	
James   New
    
	
 
    	
Title:
    	
CEO
    
	
 
    	
Date:
    	
11/12/03
    

 

3EXHIBIT 10.16

 

	
 
    	
[*]         Certain confidential information contained in this document, marked   by brackets, has been omitted and filed separately with the Securities and   Exchange Commission pursuant to Rule 406 of the Securities Act of 1933,   as amended.
    

 

MANUFACTURING AND SUPPLY AGREEMENT
  FOR TRANSDERMAL FENTANYL

 

THIS MANUFACTURING AND SUPPLY AGREEMENT (the “Agreement”) is made as of November 12th, 2003 (the “Effective Date”), by and between Abrika LLLP, a Florida limited liability limited partnership (“Abrika”), with offices at 13800 N.W. 2nd St., Suite 190, Florida 33325 and Corium International, Inc., a Delaware corporation having a place of business at 2686 Middlefield Road, Suite G, Redwood City, CA 94063 (“Corium”; together with Abrika, the “Parties”).

 

RECITALS

 

1.                                      The Parties have previously entered into a Product Development, Collaboration and License Agreement dated May 11.  2002 under which the Parties agreed to collaborate with respect to transdermal fentanyl patches.

 

2.                                      Article 2.4 of the Product Development, Collaboration and License Agreement makes reference to the Parties concluding the “Supply Agreement” following Stage 1 completion in the “Licensed Product Development” Agreement.

 

3.                                      Corium and Abrika now wish to execute the Manufacturing and Supply Agreement for Transdermal Fentanyl as originally contemplated in the “Development Agreement”.

 

NOW, THEREFORE, in consideration of the foregoing recitals, it is agreed between the Parties as follows:

 

1.                                      Definitions—all definitions used in this Agreement shall have the same meaning as originally described in the “Product Development, Collaboration and License Agreement”.

 

2.                                      Exclusivity of Supply—During the term of the Agreement and subject to the terms and conditions set forth herein, Corium shall manufacture and supply exclusively to Abrika (or a designated affiliate of Abrika), and Abrika shall purchase exclusively from Corium all of Abrika’s commercial requirements of the Licensed Product in the Territory in such quantities as from time to time may he ordered by Abrika.  If Corium elects not to manufacture any part of Abrika’s commercial supply requirements for the Licensed Product, then Abrika shall be entitled to manufacture the Licensed Product in an Abrika facility or a designated third party manufacturer, as described in further detail in Article 5 of this Agreement.

 

 

3.                                      Forecasting, Ordering of Licensed Product—A.) Abrika shall periodically submit purchase orders for the Licensed Product to Corium, which purchase orders shall set forth the specific quantities needed, delivery date and shipping instructions.  Specifically, Abrika shall deliver to Corium at least [*]prior to the calendar quarter in which Abrika’s first commercial sale of such Licensed Product is projected to occur, an annual forecast of Abrika’s requirements for such Licensed Product.  [*] prior to Abrika’s first commercial sale or Licensed Product, Abrika will issue a firm Purchase Order and requested delivery for such Licensed Product (which shall be subject to agreement by Corium which agreement shall not be unreasonably withheld).  Thereafter, Abrika shall deliver to Corium within [*] after the beginning of each calendar quarter, Abrika’s firm order and delivery dates for such Licensed Product for the next calendar quarter and a forecast of its quantity requirements for such Licensed Product for the subsequent [*]; B.)  The total amount of Licensed Product ordered by Abrika for delivery in any calendar quarter may not be less than [*] of Abrika’s most recent required forecast for such Licensed Product for such quarter.  In addition, Corium’s supply obligation will not extend to more than [*] of Abrika’s most recent forecast for such Licensed Product for such quarter.  If an Abrika Licensed Product requirement for any quarter exceeds [*] of Abrika’s most recent forecast for such Licensed Product for such calendar quarter, Corium and Abrika will discuss in good faith the additional amount, if any, that Corium is willing to supply consistent with its other obligations; C.) If Corium fails ship at least [*] of the amount of any Licensed Product properly ordered by Abrika hereunder, as measured over a period of [*] or more consecutive days, Abrika may so notify Corium and Abrika and Corium will promptly, but not more than [*] after notice, prepare and implement a plan as to now to remedy the situation which may involve new or expanded production facilities or a third party producer.

 

4.                                      Deliver and Risk of Loss—Legal title and risk of loss with respect to the Licensed Product furnished by Corium to Abrika shall pass to Abrika upon delivery which shall he F.O.B. Corium’s point of manufacture.  Corium shall be required to ship the Licensed Product to only a single drop point unless the Parties otherwise agree.

 

5.                                      Standby Manufacturing Rights—l.) If Corium fails to implement a plan to remedy an acute shortfall in projected supply obligations as discussed in Article 3.C and Corium is either:  a) unable to meet its manufacturing and supply obligations hereunder; or b) there occurs a material shortfall of supply of the Licensed Product by Corium to Abrika; or c) circumstances arise whereby it is inevitable that a shortfall in supply will occur, then Abrika shall have the right to manufacture the Licensed Product during such period of shortfall or failure of supply by Corium ( “the Standby Period”).  Abrika’s right to Manufacture Licensed Product during the Standby Period shall be strictly in accordance with the provisions of this Article which follows:

 

A.) At Abrika’s request, Corium shall supply Abrika with such manufacturing technology as is necessary to enable Abrika to provide alternate manufacturing capacity should Corium be unable to supply as described in Article 2.  In view of lead times required to establish capacity and otherwise prepare to manufacture, Abrika shall have the right to request and be supplied with such technology and assistance directly from Corium while resolution of the supply interruption at Corium may still be pending, so as to enable Abrika to manufacture during the Standby Period without interruption of supply; B.) Corium shall lend Abrika all reasonable assistance and advice in relation to the acquisition of equipment for the purposes of, and only for the purposes of, the establishment of the Abrika alternate manufacturing capacity; C.) Corium shall grant a license to Abrika to manufacture which will remain in effect for the duration of the Standby Period.  The grant of this license is also subject to Corium obtaining the right to sub-license to Abrika any third party owned technology relating to its rights to develop, manufacture and supply the Licensed Product.  Corium agrees that it shall use all reasonable efforts to obtain such a right to sublicense; D.) In the event that Abrika exercises its right to establish alternate manufacturing capacity as set out in Article 5, shall within 30 days or its decision to exercise such right pay to Corium a reasonable technology transfer fee to be negotiated.  Abrika shall pay royalties to Corium on all Licensed Product manufactured by Abrika pursuant to Article 5 of the “Licensed Product Development and Collaboration and License Agreement”; E.) Corium shall notify Abrika in writing of its ability to recommence manufacture of Licensed Product.  Such written notice shall state the date on which Corium is able to recommence its supply of Licensed Product to Abrika.  Abrika’s right to manufacture pursuant to this Article 5c and the license granted in Article 5 shall cease on the date and for such period as Corium is able to meet its manufacturing and supply obligations unless and until any of the events in Article 5 reoccurs.

 

2.) In the event that Corium, or any of its assigns or successors, decides to terminate the manufacturing and supply agreement on Licensed Product for reasons other than Abrika’s material breach, Corium will affect a complete technology transfer in stages on this Licensed Product to Abrika, or an alternative manufacturing site selected by Abrika.  The staged transfer of the manufacturing platform to Abrika is intended to minimize any possible disruptions to supply.  Abrika will have the right to relocate the core manufacturing equipment on which the

 

*Confidential Treatment Requested.

 

2

 

Licensed Product is made, as well as the specialized analytical equipment necessary to test and quality control the finished Licensed Product.  A partial list, by example, of this equipment includes [*].  Abrika will be allowed to appropriate this equipment for no cost in the process of setting up a new manufacturing site.  [*].

 

6.                                      Supply Price of Licensed Product—A.) Corium’s Cost of Goods sold with regard to manufacture and supply of the Licensed Product shall at all times be equal to the greater of:  (a) [*]of the Net Sales Price received by Abrika for the sale of such Licensed Product, or (b) Corium’s fully burdened manufacturing cost plus [*].

 

7.                                      Purchase Price and Payments—A.) The purchase price for the Licensed Product Licensed Product shall be the Supply Price; B.) Corium shall he entitled to include [*] as part of its fully burdened manufacturing cost; C.) Corium may ship Licensed Product to Abrika when reasonably sized manufactured lots have been completed, but in no case should such shipments occur more frequently than on a monthly basis, unless otherwise requested by Abrika; D.) Abrika shall pay, as applicable, within [*] from the date each Corium invoice for shipped Licensed Product is received by Abrika, provided that such invoice date shall not be earlier than the shipment date for the respective order of the Licensed Product.  A fax copy of invoice and shipping documents is sufficient for payment.

 

8.                                      Royalty Payments—The royalty payments stated herein are identical to those described in the original “Licensed Product Development, Collaboration and License Agreement”, and are repeated here only for the purposes of clarity.  Abrika shall pay to Corium the following royalties during the Term of the Agreement:

 

A.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Product in the United States so long as Corium is manufacturing and supplying the Licensed Product to Abrika pursuant to the terms of this Supply Agreement; or

 

B.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Product in the United States if:  (i) Corium is not manufacturing and supplying Abrika the Licensed Product to Abrika pursuant to the terms of this Supply Agreement, and (ii) Corium has developed Project IP which is being actively utilized in connection with the Licensed Product; or

 

C.                                    [*] of the Net Sales Price received by Abrika from the sale of the Licensed Licensed Product in the United States if:  (i) Corium is not manufacturing and supplying the Licensed, Product to Abrika pursuant to the terms of this Supply Agreement, and (ii) Corium has not developed Project IP which is being actively utilized in connection with the Licensed Product.

 

D.                                    For all sales of the Licensed Product outside the United States, the Parties shall determine the amount of royalties to be paid to Corium on a case-by-case basis.  The Parties agree to negotiate in good faith to determine a value for such royalties which accurately reflects the contribution of each Party towards the realization of such sales of the Licensed Product.

 

9.                                      Audit Rights—Corium and Abrika shall keep, and shall cause necessary third parties to keep, such records as necessary to determine accurately the sums due to Corium under this Supply Agreement.  Such records shall be retained by both Parties and shall be made available for inspection, review and audit, at any time during the applicable year and for three (3) years

 

*Confidential Treatment Requested.

 

3

 

thereafter.  At the request and expense of Corium, a certified public accountant appointed by Corium may audit all of Abrika’s accounting reports and payments made to Corium pursuant to this Supply Agreement, provided that such audits may not he performed by Corium more than once per year.

 

10.                     Regulatory Compliance—It shall be Corium’s responsibility to obtain and maintain all necessary governmental approvals and permissions which may be required in relation to the facility location for the manufacture of the Licensed Product and comply with all applicable laws and governmental regulations in this respect including FDA certification.  Abrika shall provide Corium with such assistance as Corium may reasonably require in obtaining such approvals and permissions, including providing Corium with such information within Abrika’s possession or control as Corium may reasonably or properly require for the purpose of obtaining and maintaining any necessary approvals or permissions.  Consistent with the Corium obligations:  a.) Corium warrants to manufacture the Licensed Product in accordance with all applicable FDA cGMP’s, DEA regulations, and any other applicable law, rule or regulation and will comply with the specifications as defined by the ANDA; and b.) Pre-Approval Inspection (PAI) - Corium will fully accommodate the involvement of Abrika, and any other contracted 3rd parties, to insure the Corium Manufacturing Group is fully compliant with all requirements and Quality Assurance items mandated by the FDA and necessary to pass the PAI; c.) Upon reasonable request by Abrika, Corium shall permit Abrika to inspect Corium’s manufacturing facilities, procedure and capabilities to insure continued compliance with this Manufacturing and Supply Agreement and applicable legal requirements; d.) During the term of this Manufacturing and Supply Agreement, each party shall notify the other immediately of any information (howsoever obtained and from whatever source) concerning any unexpected side effect, injury, toxicity or sensitivity reaction, or any unexpected incidence associated with any aspect of the manufacturing process for the Licensed Product.

 

11.                               Term and Termination—A.) This Agreement shall remain in effect for 20 years from the date hereof, unless terminated earlier either by; a) Corium, pursuant to their rights delineated in Article 11B; or b) due to an early termination of the Development and License Agreement; B.) Corium may terminate the “Manufacturing and Supply Agreement”, without further liability, upon [*] prior written notice to Abrika, such option to be exercised not earlier than [*] following the first commercial sale of the Licensed Product.  If Corium terminates they will cooperate with Abrika to affect a complete and sufficient transfer and migration of any and all information, data, intellectual property or processes relevant to development, or production of the Licensed Product to Abrika or its delegate, including without limitation any existing pre-clinical and clinical information; C.) Either party shall have the right to terminate this Agreement upon the occurrence of any of the following events, subject to applicable law:  a.) The material violation by the other party of any of the terms or conditions of this Agreement, provided that the party in violation shall be notified in writing by the other or such alleged violation, and shall have a period of sixty (60) days within which to rectify the same.  Provided further, that if at the end of such sixty (60) day period the party in violation is making a good faith effort to cure, a reasonable time thereafter shall be allowed for such cure; b.) [*]; c.) [*].

 

12.                               Warranties and Other Undertakings—A.) Corium warrants, that at the time of shipment, the Licensed Product supplied by it shall:  a.) meet the specifications agreed between Corium and Abrika per the Licensed Product specifications defined in the Quality System

 

*Confidential Treatment Requested.

 

4

 

Document appended to this Supply Agreement ; B.) Be manufactured in accordance with cGMP, when required, for clinical and regulatory purposes and shall meet other applicable legal and regulatory requirements; C.) Corium warrants that the annual production capacity for the Licensed Product will be no less than [*] per year, and that such capacity will be available for production of commercial Licensed Product by January 2005.

 

B.)  Right of Rejection—If any delivery of Licensed Product fails to comply to the Licensed Product specifications, Abrika shall notify Corium promptly upon discovery, but no later thirty 30 i days from their discovery:

 

1.                                      Without prejudice of any additional rights arising from the delivery of defective Licensed Product Abrika shall have the right to reject any batch containing defective Licensed Product.  Corium shall replace such rejected batch with Licensed Product that conform with the specifications within four (4) weeks of notification thereof.  All costs and expenses incurred by Abrika or its licensees in connection therewith (including return or disposal of defective Licensed Product) will be borne by Corium.  Payment for the Licensed Product on receipt of the delivery shall not be deemed to imply an acceptance of the Licensed Product(s).  If Corium fails to replace Licensed Product(s) in such time period, Abrika or its licensees will either be entitled to a.) seek a remedy for the lack of supply as defined in Article 5 of this agreement; or b.) shall receive a supply of Licensed Product that conforms to the specifications equivalent to the same amount or Licensed Product which was rejected by Abrika at a [*] to the supply price the Licensed Product then in effect.

 

2.                                      Abrika shall have no further claims fair indirect or consequential damages against Corium, except in the event of a loss or injury is caused by negligence, willful misconduct or criminal act or omission of Corium.

 

3.                                      Corium shall hold Abrika harmless and indemnify Abrika against any claims from third parties as a result of a defect of Licensed Product.  Corium warrants that it has appropriate and adequate insurance to cover claims or damages for which it shall be liable under the terms of this Agreement.

 

13.                               Abrika Market Performance Requirements—At the end of [*]following the first commercial introduction of the Licensed Product, and for each [*]segment subsequent to the initial [*] period for which Abrika has exclusive distribution rights to the Licensed Product, if Abrika drops below a [*] for [*], based upon unit sales of the Licensed Product in the territory, as defined by standard industry measures such as IMS or Scott-Levin, then upon a [*] written notice by Corium, Abrika’s exclusive rights to that Licensed Product in the Territory shall become nonexclusive.  Abrika will always have a [*] right to cure after notice by Corium.  If Corium, its affiliates or a third party, then elect to independently pursue the marketing and sales of the Licensed Product (under Section VI., VI B.1) [*] royalty on net sales will always be due Abrika.  In such event, Abrika will grant a co-exclusive license to Corium to make, use or sell the Licensed Product in the U.S. market territory,

 

14.                               Dispute Resolution—In an effort to resolve informally and amicably any claim, controversy or dispute arising out of or related to the interpretation, performance or breach of the Agreement (a “Dispute”) without resorting to litigation, each party shall notify the other party to

 

*Confidential Treatment Requested.

 

5

 

the Dispute in writing that requires resolution.  Such notice shall set forth the nature of the dispute, the amount involved or associated damages, if any, and the remedy sought.  Each party shall promptly designate an executive-level employee to investigate, discuss and seek to settle the matter between them.  If the two designated representatives are unable to settle the matter within 30 days after such notification, the matter shall he submitted to the parties’ respective Chief Executive Officers for consideration.  If the settlement cannot be reached through their efforts within an additional 30 days (or longer time period as they shall agree upon in writing), each party shall be free to pursue whatever legal action it shall determine in its sole discretion.

 

15.                               Force Majeure—The parties hereto shall not be liable for non-fulfillment of their respective obligations hereunder, if such non-fulfillment is due to strikes, riots, war, invasion, acts of God, fire, explosion, floods, delay of carrier, shortages or failure in the supply of material, acts of government agencies of instrumentalities, judicial action, labor disturbance and/or other contingencies beyond the control of the party affected (hereinafter “Force Majeure”).  The party affected by Force Majeure will provide the other party will full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use its best endeavors to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable.

 

16.                          Indemnification—A. Corium shall indemnify and hold Abrika harmless from and against any and all liabilities, claims, demands, damages, costs, expenses or money judgments (including attorney’s fees incurred by or rendered against Abrika for personal injury, sickness, disease or death.) which arise out of:  a) the negligence of Corium in carrying out the provisions of this Agreement; and b.) the breach by Corium of its warranties contained in Article 8 of this Agreement.

 

B.                                    Except to the extent that Corium is obligated to provide indemnification as provided in Article 9, Abrika shall indemnify and hold Corium harmless from and against any and all liabilities, claims, demands, damages, costs, expenses or money judgments (including attorney’s fees but excluding consequential loss) incurred or rendered against Corium for personal injury, sickness, disease or death which arise out of :  a.) use, sale or other distribution of Licensed Product by Abrika or any sublicensee of Abrika; b.) the breach of any representation or warranty made or given by Abrika with respect to Licensed Product; c.) the use by Abrika, of information or data developed pursuant to this Agreement, provided that if such information or data is Corium proprietary information it is reasonably believed by Corium to be, substantially accurate and complete; d.) any other action or omission by Abrika relating to the Licensed Product or the subject matter of this Agreement,

 

C.                                    Corium and Abrika agree to the extent reasonably practicable and consistent with normal insurance overage to cooperate with each other in the defense of any claims by third parties to which this Article applies.  If either of the parties wishes to exercise its right to be indemnified under Article 9, such rights will be subject to the party seeking indemnity who will:  a.) promptly notify the indemnifier of the claim to be indemnified; b.) allow the indemnifier, if the indemnifier so requests, to conduct and control (at the cost and expense of the indemnifier), the defense of such a claim and any related settlement negotiations; and c.) offer all reasonable assistance to the indemnifier) (at the cost and expense of the indemnifier) and making no admission prejudicial to the defense of such a claim.

 

6

 

17.                               Miscellaneous

 

17.1.                     Notices.  Any notice required to be given under this Agreement shall be in writing in English and shall he deemed duly given if signed by or on behalf of a duly authorized officer of the Party giving the notice, and if left at, or sent by registered or recorded delivery post or by facsimile transmission to:

 

	
Corium:
    	
Corium International, Inc.
    
	
 
    	
2686 Middlefield Road, Suite G
    
	
 
    	
Redwood City, California 94063
    
	
 
    	
Attention: Adrian Faasse
    
	
 
    	
FAX: (650) 298-8012
    
	
 
    	
 
    
	
 
    	
with a copy to:
    
	
 
    	
 
    
	
 
    	
Attention:
    
	
 
    	
FAX:
    
	
 
    	
 
    
	
Abrika:
    	
Abrika LLLP
    
	
 
    	
13800 N.W. 2nd Street
    
	
 
    	
Suite 190
    
	
 
    	
Sunrise, Florida 33325
    
	
 
    	
Attention: James New
    
	
 
    	
FAX: (954) 315-6600
    

 

or at such other address as either Party may direct the other in writing

 

Any such notice or other communications shall be deemed to be given:  at the time when the same is handed or left at the address of the Party to be served:  by post on the day (not being a Sunday or public holiday) five days following the day of posting; and in the case of a facsimile transmission, on the next following day, provided that a confirming copy of it is sent by registered or recorded delivery post to the other Party at the address given in this Agreement within 24 hours after the transmission.

 

17.2.                     Headings.  The headings preceding the text of the Articles and Sections of this Agreement are inserted solely for convenience of reference, and do not constitute a part of this Agreement or affect its meaning, construction, or effect.

 

17.3.                     Integration.  This Supply Agreement and the Licensed Product Development, Collaboration and License Agreement previously executed, set forth the entire agreement between the Parties with respect to the subject matter hereof, and supersede all prior agreements and understandings with respect to such subject matter.

 

17.4.                     Waiver.  No consent by any Party to or waiver of a breach or default by the other, whether express or implied, shall constitute a consent to, waiver of, or excuse for any difference

 

7

 

or subsequent breach or default.  All waivers hereunder must be signed by the Party against which such waiver is asserted.

 

17.5.                     Counterparts.  This Agreement may be executed in multiple counterparts, and each counterpart shall be deemed an original of this Agreement.

 

17.6.                     Governing Law.  The validity and interpretation of this Agreement shall be governed and construed in accordance with the United States patent laws and the laws of the State of Florida without regard to the conflicts of laws principles thereof.

 

17.7.                Unenforceability of Provision(s).  Unenforceability of any provision or provisions hereof shall not render unenforceable, or impair, the remainder thereof.  If any provision or provisions of this Agreement shall be deemed invalid, illegal or unenforceable, either in whole or in part, this Agreement shall he deemed amended to delete or modify as necessary the offending provision or provisions and to alter the bounds thereof in order to render it valid and enforceable.

 

17.8.                     Assignment.  Corium and Abrika shall not assign this Agreement or any part thereof without the prior written consent of the other party.  The parties may assign or sell the same to an affiliate or in connection with the transfer or sale of substantially its entire business to which this Agreement pertains, in the event of its merger or consolidation with another company or in the event of the transfer or sale to a wholly-owned subsidiary.

 

17.9.                     Confidentiality.  Neither party shall disclose to any third party any information which is not in the public domain (“Confidential Information”) and which was obtained from the other party in connection with this Agreement.  This obligation of secrecy shall not apply to information which must be disclosed to governmental agencies for Licensed Product registration purposes.  In addition, the secrecy obligation shall expire for Confidential Information which:

 

a.                                      is or becomes part of the public domain without violation of this Agreement;

 

b.                                      was already in its possession at the time of receipt from the disclosing part, as shown by documentary evidence;

 

c.                                       after the date of this Agreement is received from a third party whose direct or indirect source is not the disclosing party.

 

The obligation of secrecy contained in this Article shall survive the duration of this Agreement for a period of five (5) years.

 

18.                               Conflict with Other Agreements.  The terms of this Agreement shall prevail in case of conflict inconsistency with the terms if any of the other Agreements.

 

8

 

IN WITNESS WHEREOF, the Parties have executed this Addendum as of the day and year first written above:

 

 

	
CORIUM INTERNATIONAL, INC.
    	
 
    	
ABRIKA PHARMACEUTICALS LLLP,
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Adrian Faasse
    	
 
    	
By:
    	
/s/ James New
    
	
Name:
    	
Adrian Faasse
    	
 
    	
Name:
    	
James New
    
	
Title:
    	
Chairman and CEO
    	
 
    	
Title:
    	
CEO
    
							

 

9

 

Amendment to

 

[*]  Fentanyl Agreements

 

This Amendment to the Collaboration Agreement (as defined below) and the Supply Agreement (as defined below), each in respect of [*] (this “Amendment”) is made and entered into as of July 24, 2013 (the “Amendment Effective Date”), by and between Par Pharmaceutical, Inc., a Delaware corporation having a place of business at One Ram Ridge Road, Spring Valley, NY 10977 (“Par”),  and Corium International, Inc., a Delaware corporation having a place of business at 235 Constitution Drive, Menlo Park, CA 94025 (“Corium”).  Each of Par and Corium is a “Party” and collectively, the “Parties”).

 

RECITALS

 

A.                                    Abrika LLLP (“Abrika”) and Corium entered into that certain Product Development, Collaboration and License Agreement, as of May 11, 2002, in connection with the development and commercialization of [*], as amended as of November 12, 2003 and September 28, 2007 (the “Collaboration Agreement”).

 

B.                                    In connection with the Collaboration Agreement, Abrika and Corium entered into that certain Manufacturing and Supply Agreement for Transdermal Fentanyl, as of November 12, 2003, relating to the manufacture and supply of [*](the “Supply Agreement” and, together with the Collaboration Agreement, the “Agreements”).

 

C.                                    In June 2007 Actavis South Atlantic LLC (“Actavis”) became the successor in interest to Abrika with respect to the Agreements.

 

D.                                    Actavis, Par and Corium entered into an Assignment and Assumption Agreement, as of November 5, 2012, pursuant to which Actavis assigned to Par all of its right, title and interest in the Agreements (the “Assignment Agreement”).

 

E.                                     In connection with the Assignment Agreement, Actavis and Corium entered into that certain Amended and Restated Settlement Agreement, as of November 6, 2012 (the “Amended Settlement Agreement”), pursuant to which Actavis and Corium agreed, among other things, that Actavis would relinquish any and all rights it had or may have had in the [*]Development Program (as defined therein) and any results thereof, and would assign the Third Line Documents (as defined therein) to Par, in the event that Corium and Par entered into an agreement to carry out development, manufacturing and commercialization activities for the [*] Product.

 

F.                                      The Parties have now agreed to amend the Agreements with this Amendment as set forth herein in order to include the [*] Product.

 

NOW, THEREFORE, in consideration of the above premises and mutual covenants contained herein, and intending to be mutually bound thereby, the Parties hereby agree to amend the Agreements as follows. Unless otherwise defined in this Amendment, capitalized terms used herein will have the same meaning as in the Agreements.

 

*Confidential Treatment Requested.

 

 

AGREEMENT

 

1.                                      Name Change.  Wherever the name Abrika or Actavis appears in any of the Agreements it is hereby replaced with the name Par.

 

2.                                      Inclusion of [*]Product.

 

a.              The terms and conditions of the Agreements, except as expressly provided in this Amendment, shall apply to the remaining development and, upon obtaining all necessary regulatory approvals, manufacture and supply of [*]  transdermal patch product formulation that is an AB-rated generic equivalent of the [*] product generally known as [*](the “[*] Product”), in addition to the reservoir patch product that is currently being supplied under the Supply Agreement.

 

b.              In addition, Corium and Par shall reasonably cooperate with each other in order to notify Actavis that the Parties have, by executing this Amendment, entered into an agreement regarding [*]Product, in order to effectuate the obligations of Actavis in connection with [*]Product set forth in the Amended Settlement Agreement.

 

3.                                      [*] Product Approval Process.  In order to qualify the [*] Product for commercial production and sale, the Parties will undertake and complete the steps set forth in Exhibit A hereto in accordance with the allocation of responsibilities, pricing and payment terms specified therein.

 

4.                                      Cost Savings.  Section 6 of the Supply Agreement is amended by adding the following as subsection B.):   The Parties anticipate that the overall price of Cost of Goods used in the [*] Product will be lower than those related to the current reservoir patch Licensed Product. The Parties will share the benefits of any such realized cost savings on a [*] .

 

5.                                      Milestone Payment.  Within five (5) business days of the Amendment Effective Date, Par will pay to Corium [*].

 

6.                                      Responsibility for Costs and Development Charges.

 

a.              Payments for development related work will be made in accordance with the estimated budget and payment provisions set forth in Exhibit A hereto; provided, however, that notwithstanding the foregoing, Corium shall provide prompt written notice to Par in the event that Corium reasonably believes that it will exceed any of the estimated costs set forth on Exhibit A hereto, and shall not, in any event, incur costs in excess of any of such estimated costs (nor shall Par be responsible for reimbursing Corium for such excess) unless Par agrees in writing to pay for such excess costs.  Corium will not be responsible for incurring or performing work that exceeds the estimated budget outlined in Exhibit A, unless agreed in writing,  nor shall Corium be responsible for completion of any work in progress that exceeds such budget.  The price of all development services will be invoiced by Corium and reimbursed by Par in accordance with this Amendment and will be billed at Corium’s standard billing rates for development, which are designed to accurately reflect estimates of Corium’s actual costs.  Pass through items will be billed at actual costs without markup or profit margin allowance.  Corium will provide Par with its standard billing rates.

 

*Confidential Treatment Requested.

 

2

 

b.              Payments for products following approval, including royalty payments, will be governed by the terms of the Collaboration Agreement.

 

7.                                      Amendments to Collaboration Agreement.  The terms and conditions of the Collaboration Agreement shall apply to the remaining development of [*]Product, except as provided in this Section 7:

 

a.              All references to the Development Program (including the definition thereof) shall, with respect to [*]Product, mean the development work set forth on Exhibit A hereto.

 

b.              The defined term “Existing Technology” is amended by inserting the word “Amendment” before the words “Effective Date” at the end of the definition.

 

c.               The defined term “Territory” is revised mean the United States and its possessions.

 

d.              All references to the Licensed Product shall include the currently marketed reservoir patch product and [*]Product.

 

e.               All references to Stage 1, Stage 2 and Stage 3, including the definitions thereof and to the extent referred to in the Collaboration Agreement in Sections 2.1.C., 2.3.A., 2.3.B., 2.3.C., 2.3.D. and 2.4 shall not apply to [*]Product.  The Exhibits attached to the Collaboration Agreement shall also not apply to [*]Product.

 

f.                2,1 B. is amended to read as follows: “ The Project Team, as described in Exhibit A of the Amendment shall meet as reasonably requested by either Party to discuss the progress of the Development Program,  but no less frequently than on a monthly basis.

 

g.               2.1. C. is amended to read as follows: Corium shall undertake all work in connection with the implementation of the Development Program in a workmanlike manner consistent with industry standards.

 

h.              The following provisions, in their entirety, shall not apply to [*]Product:  Articles 3, 7, 12, 15 and 16, and Sections 2.1.D., 2.3.A through E., 5.1.D., 13.2. B., C. and E.

 

i.                  Section 17.1 shall be amended by deleting the addresses set forth therein and replacing them in their entirety as follows:

 

	
Corium:
    	
Corium   International, Inc.
    
	
 
    	
235   Constitution Drive
    
	
 
    	
Menlo   Park, CA 94025
    
	
 
    	
Attn:   Christina Dickerson
    
	
 
    	
Facsimile   No.: (650) 298-8012
    
	
 
    	
 
    
	
With   a copy to:
    	
Fenwick &   West
    
	
 
    	
555   California Street, 12th Floor
    
	
 
    	
San   Francisco, CA 94104
    
	
 
    	
Attn:   Ralph Pais
    
	
 
    	
Facsimile   No.:
    
	
 
    	
 
    
	
Par:
    	
Par   Pharmaceutical, Inc.
    
	
 
    	
One   Ram Ridge Road
    

 

*Confidential Treatment Requested.

 

3

 

	
 
    	
Spring   Valley, NY 10977
    
	
 
    	
Attn:   Vice President, Business Development
    
	
 
    	
Facsimile   No.: (201) 802-4600
    
	
 
    	
 
    
	
With   a copy to:
    	
Par   Pharmaceutical, Inc.
    
	
 
    	
300   Tice Boulevard
    
	
 
    	
Woodcliff   Lake, NJ 07677
    
	
 
    	
Attn:   General Counsel
    
	
 
    	
Facsimile   No.: (201) 802-4600
    

 

8.                                      Amendments to the Supply Agreement.  The terms and conditions of the Supply Agreement shall apply to the development of [*]Product, except as provided in this Section 8:

 

a.              The first sentence of Section 13 of the Supply Agreement shall be amended by replacing such sentence in its entirety with the following:

 

“For each 12 month period subsequent to November 6, 2012 for which Par has exclusive distribution rights to the Licensed Product and [*]Product, if sales of the Licensed Product and [*]Product, collectively, drops below [*] of the overall market share for transdermal [*] system products for 5 consecutive months, based upon unit sales of the Licensed Product and [*]Product, collectively, in the Territory, as defined by standard industry measures such as IMS or Scott-Levin, then upon 30-days’ written notice by Corium, Par’s exclusive rights to the Licensed Product and [*]Product in the Territory shall become nonexclusive.”

 

b.              Notwithstanding Section 18 of the Supply Agreement, the provisions of this Amendment shall prevail with respect to those matters specifically addressed herein.

 

9.                                      No Further Amendments:  Except as expressly amended by the provisions hereof, the Agreements remain in full force and effect and binding on the Parties hereto.  Corium hereby acknowledges and agrees that, except as specifically set forth in Exhibit A hereto, there are no outstanding or accrued payment obligations, other than related to the purchase and sale of products in the ordinary course of business between the parties, under any of the Agreements owed by Par as of the Amendment Effective Date (including any that may be owed or payable by Abrika or Actavis), and no acts, omissions or conditions have occurred that might otherwise give rise to a claim for termination under any of the Agreements.  Par is not aware of any acts, omissions or conditions that have occurred that might give rise to a claim for termination under any of the Agreements.

 

10.                               Counterparts.  This Amendment may be executed in any number of counterparts, each of which when so executed and delivered will be deemed an original, and all of which together shall constitute one and the same agreement.  This Amendment may be executed and delivered

 

*Confidential Treatment Requested.

 

4

 

by facsimile and upon such delivery the facsimile signature will be deemed to have the same effect as if the original signature had been delivered to the other party.

 

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed as of the date first written above by their duly authorized officers in acceptance of its terms:

 

	
Par   Pharmaceutical, Inc.  
    	
 
    	
Corium   International, Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Paul Campanelli
    	
 
    	
By:
    	
/s/   Peter D. Staple
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Print   Name:
    	
Paul   Campanelli
    	
 
    	
Print   Name:
    	
Peter   D. Staple
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    	
Title:
    	
President   & CEO
    
									

 

5

 

EXHIBIT A

Steps for Product Approval

 

MANUFACTURE OF NEW [*]  CLINICAL BATCHES FOR BIOEQUIVALENCE AND IRRITATION, SENSITIZATION AND ADHESION (ISA) STUDIES

Corium will manufacture one active and one placebo batch of [*]  patches for new clinical studies that Par wishes to conduct in order to file either an amendment to the current ANDA or a new ANDA.  The active batch will be used for BE and Adhesion studies while the placebo batch will be used for IS (Irritation and Sensitization study).

 

The costs outlined below are estimates for the work described and subject to change if the scope is altered by mutual written agreement of the Parties.  Corium shall submit to Par invoices on a monthly basis, which invoices shall be in such form as Par shall reasonably determine and shall provide sufficient detail such that Par may ascertain the nature of the work performed by Corium.  Payments for such development work will be made net thirty (30) days following Corium’s invoice date, which date shall not be earlier than completion of the applicable development work.

 

Scope of Work

·                  [*]

 

Cooperation

·                  During the course of remaining development, the Parties shall meet no less than monthly to discuss project status, current issues, and further work needed to submit an ANDA containing [*]Product, obtain approval therefor, and launch [*]Product.

 

Budget

·                  [*]

 

Timeline Assumptions

·                  [*]

 

Terms

[*]

 

Budget and Timeline Assumptions

·                  [*]

 

CLINICAL STUDIES

[*]

 

REGULATORY WORK AND ESTIMATED COSTS THROUGH ANDA FILING

·                  [*]

 

COMMERCIALIZATION COSTS

·                  [*].

 

*Confidential Treatment Requested.

 

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