EXHIBIT 10.20 Drug Product Development and Clinical Supply Agreement

1.1

AFFILIATE of a party hereto shall mean any entity that controls or is controlled by such party, or is under common control with such party. For purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of another entity (or other comparable interest for an entity other than a corporation).

1.2

BATCH shall mean a specific quantity of a Drug Product comprising a number of units mutually agreed upon between NTI and BPS, and that (a) is intended to have uniform character and quality within specified limits, and (b) is Produced according to a single manufacturing order during the same cycle of manufacture.

1.3

BILL OF MATERIALS may refer to either a manufacturing bill of materials or packaging bill of materials and in each case shall mean the document specifying the Components, excipients and other materials required for Production of Drug Product, which in each instance required shall be developed by BPS and agreed to in writing by NTI. In each instance so required, BPS shall deliver the Bill of Materials to NTI. NTI

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Certain confidential portions of this Exhibit were omitted by means of blackout of the text (the “Mark”). This Exhibit has been filed separately with the Secretary of the Commission without the Mark pursuant to the Company’s Application Requesting Confidential Treatment under Rule 24b-2 under the 1934 Act.

1.4

BPS SOPs shall mean BPS’ Standard Operating Procedures which shall be deemed reviewed and approved by NTI prior to entering into each Project Plan, and Drug Product-Specific SOPs; provided, however, if BPS proposes to modify any Drug Product-Specific SOPs after commencement of a Project Plan, then such modification to such Drug Product-Specific SOP shall not be implemented unless and until NTI has reviewed and confirmed approval of such modification.

1.5

BULK DRUG SUBSTANCE shall mean the active compound, as set forth in the Development Plan or Project Plan, to be supplied by NTI for use in Production of Drug Product.

1.6

cGMP shall mean current Good Manufacturing Practices as defined in the FDA rules and regulations, or as defined in another Regulatory Authority’s rules and regulations as explicitly set forth in a Project Plan, including, without limitation, the United States regulations set forth at 21 CFR Parts 210-211 and 600-610, as appropriate.

1.7

CANCELLATION FEES shall mean the fees set forth in Section 3.3 that are payable by NTI in the event that NTI cancels the Production of any Batch of Drug Product set forth in the Project Plan, except as otherwise provided herein.

1.8

COMPONENTS shall mean all components used by BPS in Production of Drug Product under this Agreement. Components are listed in the Bill of Materials and/or the Project Plan, and such Components are identified as Components supplied by NTI (“NTI Supplied Components”) and Components supplied by BPS (“BPS Supplied Components”).

1.9

CONFIDENTIAL INFORMATION shall mean all information and data provided by the disclosing party to the receiving party (“Recipient”), subject to Section 10.7, except any portion of such information and data which:

(a)

is known to the Recipient as evidenced by its written records before receipt thereof from the disclosing party;

(b)

is lawfully disclosed to the Recipient on a non-confidential basis by a third person who has the right to make such disclosure;

(c)

is or becomes part of the public domain through no fault of the Recipient; or

(d)

the Recipient can reasonably establish is independently developed by Recipient without use of the information disclosed by the disclosing party.

1.10

DEVELOPMENT shall mean studies or activities conducted by BPS to develop, to optimize or to transfer from NTI to BPS a process to Produce Drug Product, in accordance with the Specifications and cGMP. Development activities shall be identified in the Development Plan.

1.11

DEVELOPMENT PLAN shall mean the written plan(s) containing the parameters for Development of Drug Product that shall be developed by BPS and agreed to in writing by NTI for each Drug Product under this Agreement, as it may be amended from time to time by written mutual agreement of the parties. Prior to commencing Development for any Drug Product, BPS shall deliver two (2) signed originals of the Development Plan to NTI. NTI shall review the Development Plan, and if acceptable, shall sign both originals of the Development Plan and return one (1) fully executed original to BPS. Each fully executed Development Plan shall be incorporated herein by reference and made a part of this Agreement. BPS shall have no obligation to commence Development for a Drug Product until NTI has executed and returned the Development Plan for such Drug Product to BPS. In the event of a conflict between any of the provisions of this Agreement and the Development Plan, the provisions of this Agreement shall govern.

1.12

DRUG PRODUCT shall mean each pharmaceutical product set forth in a Development Plan, or set forth in a Project Plan that is to be Produced by BPS in finished dosage form for development and/or clinical use only.

1.13

DRUG PRODUCT-SPECIFIC SOPs shall mean the standard operating procedures (SOPs) that are specific to Drug Product.

1.14

FDA shall mean the United States Food and Drug Administration or any successor entity thereto.

1.15

FD&C ACT shall mean the United States Federal Food, Drug and Cosmetic Act, as it may be amended from time to time.

1.16

LABELING shall mean all labels and other written, printed, or graphic matter upon: (a) Drug Product or any container, carton, or wrapper utilized with Drug Product, or (b) any written material accompanying Drug Product.

1.17

MASTER BATCH RECORD (MBR) shall mean the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained in BPS’ standard format by BPS, using NTI’s master formula and technical support.

1.18

PRODUCTION or PRODUCE shall mean all or a portion of the process of formulating, filling, packaging, inspecting, labeling, and testing of Drug Product by BPS (or by a BPS subcontractor on behalf of BPS).

1.19

PROJECT PLAN shall mean the written plan(s) containing the parameters for Production of Drug Product, which shall be developed by BPS and agreed to in writing by NTI for each Drug Product under this Agreement, as it may be amended from time to time by written mutual agreement of the parties. Prior to commencing Production of any Drug Product, BPS shall deliver two (2) signed originals of the Project Plan to NTI. NTI shall review the Project Plan, and if acceptable, shall sign both originals of the Project Plan and return one (1) fully executed original to BPS. Each fully executed Project Plan shall be incorporated herein by reference and made a part of this Agreement. BPS shall

have no obligation to commence Production of a Drug Product until NTI has executed and returned the Project Plan for such Drug Product to BPS. In the event of a conflict between any of the provisions of this Agreement and the Project Plan, the provisions of this Agreement shall govern.

1.20

PURCHASE PRICE shall mean the amount to be paid by NTI, as specified in each Development Plan and Project Plan.

1.21

QUALITY AGREEMENT shall mean a written agreement that sets forth the responsibilities of BPS and NTI with respect to Production activities and quality assurance activities in connection with the Development Plans, Project Plans and this Agreement. Each Quality Agreement shall be incorporated herein by reference and made a part of this Agreement. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement, the provisions of this Agreement shall govern.

1.22

QUALITY CONTROL MASTER DOCUMENT (“QCMD”) shall mean a listing of the analytical testing and corresponding specifications (including Specifications, as set forth in Section 1.26 below) to be performed on the Bulk Drug Substance, raw materials, and Drug Product.

1.23

REGULATORY AUTHORITY shall mean those governmental agencies or authorities responsible for regulation of Drug Product in the United States or outside of the United States. BPS shall have no obligation to Produce Drug Product in compliance with the requirements of a Regulatory Authority not specified in the applicable Project Plan.

1.24

REGULATORY PLAN shall mean the written plan(s) containing the parameters for regulatory services and support services provided by BPS in connection with NTI’s development and maintenance of regulatory submissions and supporting documentation, as it may be amended from time to time by written mutual agreement of the parties. Upon the written request of NTI (in its sole discretion), a Regulatory Plan will be developed by BPS, and if acceptable to NTI, BPS shall deliver two (2) signed originals of the Regulatory Plan to NTI. NTI shall review the Regulatory Plan, and if acceptable, shall sign both originals of the Regulatory Plan and return one (1) fully executed original to BPS. Upon full execution, the Regulatory Plan shall be incorporated herein by reference and made a part of this Agreement. BPS shall have no obligation to perform regulatory services or provide support services for a Drug Product until NTI has executed and returned the Regulatory Plan for such Drug Product to BPS. For the avoidance of doubt, BPS acknowledges and agrees that NTI manages, and shall continue to manage, regulatory affairs for all NTI products, including Drug Products. In the event of a conflict between any of the provisions of this Agreement and the Regulatory Plan, the provisions of this Agreement shall govern.

1.25

RELEASED EXECUTED BATCH RECORD shall mean the completed Batch record, and associated exception reports and QCMD that are created for each Batch of Drug Product.

1.26

SPECIFICATIONS shall mean the specifications for the Drug Product that are set forth in the QCMD and in the Master Batch Record for that Drug Product, and to the extent that BPS is required to test the Bulk Drug Substance, the specifications for the Bulk Drug Substance.

2.1

Initiation: NTI hereby engages BPS, and BPS hereby agrees, to Develop and Produce Drug Product(s) and to perform services in compliance with the Development Plan(s), Project Plan(s) and/or the Regulatory Plan(s) and the Quality Agreement (as applicable). Each such executed Quality Agreement, Development Plan, Project Plan and Regulatory Plan constitutes an integral part of this Agreement, and is incorporated herein by reference. Upon execution of a Project Plan for each Drug Product, BPS shall commence Production of such Drug Product pursuant to the Project Plan. Upon execution of a Regulatory Plan for each Drug Product, BPS shall commence providing services pursuant to the Regulatory Plan.

2.2

Documentation: Drug Product-specific Master Batch Records shall be reviewed and approved by BPS and by NTI prior to commencement of Production of such Drug Product. Any material change to an approved Drug Product-specific Master Batch Record will be reviewed and approved by BPS and by NTI prior to said change being implemented. For purposes of clarification, “material” changes include (without limitation) changes that may or would affect the strength, identity, safety, purity or quality or the Drug Product, or changes in any process described in the Master Batch Record. For each Batch of Drug Product Produced hereunder, BPS shall use a copy of the Master Batch Record. Each such copy of the Master Batch Record that is used for such Batch of Drug Product Produced hereunder shall be assigned a unique batch number by BPS. NTI may, in its sole discretion, assign and add an additional unique lot number. Any deviation from the manufacturing process that is specified in the Master Batch Record shall be documented in the copy of the Master Batch Record for that Batch, and shall be investigated in accordance with approved BPS policies for such investigations and the Quality Agreement. BPS shall provide NTI with complete copies of all such Master Batch Record copies that are assigned a unique batch number, as well as complete copies of all supporting Development and Production documentation in a form reasonably suitable for NTI’s submission to the FDA and other Regulatory Authorities as specified in a Project Plan. Also, BPS shall provide NTI with complete copies of each Released Executed Batch Record.

2.3

Bulk Drug Substance and Components Supply: NTI, at its sole cost and expense (including, without limitation, shipping costs), shall supply to BPS, in a timely manner, all amounts of Bulk Drug Substance required to satisfy the terms of this Agreement and all NTI Supplied Components. Except as otherwise specifically set forth in the Development Plan or the Project Plan, on receipt of the Bulk Drug Substance, BPS’ sole obligations with respect to evaluation of the Bulk Drug Substance shall be to review the accompanying certificate of analysis to confirm that the Bulk Drug Substance conforms with the specifications for the Bulk Drug Substance.

2.4

Bulk Drug Substance and Component Delivery Delays:

2.4.1 

BPS shall have no responsibility for delays in delivery of Drug Product caused by delays in receipt of Bulk Drug Substance or NTI Supplied Components.

2.4.2 

BPS shall have no responsibility for delays in delivery of Drug Product caused by delays in receipt of BPS Supplied Components, provided that BPS complied with the applicable BPS Supplied Component vendor’s ordering lead times. If

NTI places an order that provides both parties with reasonable opportunity to comply with their respective Component vendor’s lead times, and the following conditions are met, *** shall be entitled to ***: (a) NTI complies with NTI Supplied Component vendor’s lead times, (b) BPS does not comply with a BPS Supplied Component vendor’s lead times, and (c) such failure by BPS to comply with BPS Supplied Component vendor’s lead time will cause a delay in Production of Drug Product of more than *** days. Notwithstanding the foregoing, in the event that NTI places an order with a requested delivery date that does not allow sufficient opportunity for BPS to comply with a BPS Supplied Component vendor’s ordering lead times, BPS will have no responsibility for resulting delays in delivery caused by delays in receipt of such BPS Supplied Components.

2.5

Importer of Record: In the event that any material or equipment to be supplied by or on behalf of NTI hereunder, including, without limitation, NTI Supplied Components and Bulk Drug Substance, is imported into the United States for delivery to BPS (“Imported Goods”), such Imported Goods shall be imported DDP Bloomington, IN (Incoterms 2000). NTI shall bear all costs and risk of loss associated with delivery of Imported Goods to BPS. NTI shall be the “Importer of Record” of such Imported Goods. As the Importer of Record, NTI shall be responsible for all aspects of the Imported Goods, including, without limitation, (a) customs and other applicable regulatory clearance of Imported Goods, (b) payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the importation and delivery of the Imported Goods to BPS, and (c) all records, documents, correspondence and tracking information required by applicable laws, rules and regulations arising out of or in connection with the importation or delivery of the Imported Goods.

2.6

Material Safety Data Sheet: NTI shall provide BPS a Material Safety Data Sheet for Bulk Drug Substance and for each Drug Product. BPS shall immediately notify NTI of any unusual health or environmental occurrence relating to Drug Product, including, but not limited to, any claim or complaint by any employee of BPS (or an employee of any of its Affiliates or a third party acting on behalf of BPS in connection with this Agreement) that the operations of BPS pursuant to this Agreement have resulted in any unusual health or safety effect on such employee. BPS shall advise NTI immediately of any safety or

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Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

2.7

Vendor and Supplier Audit and Certification: NTI shall be responsible for certifying and auditing all Drug Product-related vendors and suppliers. Upon *** request, *** will provide *** from any audits previously conducted by *** with respect to vendors and suppliers of *** Supplied Components *** that will be used in the Production of Drug Product under a Project Plan. *** may redact such summary as necessary to comply with *** confidentiality obligations to a third party.

2.8

Storage: During the term of this Agreement, BPS shall not be required to store Bulk Drug Substance for more than *** days prior to commencement of Production of Drug Product; provided, however, upon NTI’s request, BPS may agree to store such Bulk Drug Substance for a period longer than *** days by its prior written agreement, and NTI shall reimburse BPS for all reasonable costs incurred by BPS in connection with such storage of Bulk Drug Substance as specified in a Project Plan. In no event shall BPS be required to store a shipment of Drug Product for more than *** days after BPS’ release of the Released Executed Batch Record for such the Drug Product; provided, however, that BPS may agree to store such Batch of Drug Product for a period longer than *** days by its prior written agreement, and further provided that NTI may agree to reimburse BPS for all reasonable costs incurred by BPS in connection with such extended storage period as specified in a Project Plan. All storage fees imposed by BPS pursuant to this Section 2.8 shall be specified in writing by BPS in advance.

2.9

Delivery Terms: BPS shall ship all accepted and released Drug Product to NTI (or to a third party designated by NTI in writing). All shipments shall be shipped EXW (Incoterms 2000) Bloomington, Indiana, freight collect, by a common carrier designated by NTI, at NTI’s expense; provided, however, that BPS shall be responsible for loading of the Drug Product on departure, and BPS shall bear all costs of such loading. NTI shall procure, at its cost, insurance covering damage or loss of Drug Product after loading and during shipping to NTI or its designee. All shipping instructions of NTI shall be accompanied by the name and address of the recipient and NTI’s desired shipping date.

2.10

Subsequent Export: NTI is and shall remain the owner of all goods and materials that are transferred by NTI to BPS in connection with this Agreement, and that are Produced by BPS for NTI hereunder. At no time shall BPS assume ownership in or title to such goods and materials of NTI. In the event that Drug Product is destined for subsequent export or re-export by NTI, then NTI, as owner of the Drug Product, is responsible for such subsequent export or re-export, and will comply with all applicable U.S. laws and regulations relating to such subsequent export or re-export.

2.11

Foreign Corrupt Practices Act: NTI acknowledges that it is not an agent of BPS in connection with the sale or resale of Drug Product. To the extent applicable to any Drug Product, NTI shall be responsible for compliance with The Foreign Corrupt Practices Act, as set forth in Title 15 of the United States Code (as it may be amended from time to time).

2.12

Deposits and Payment for Drug Product and Development: Promptly after execution of each Development Plan and Project Plan, NTI shall pay to BPS the deposit, if any, set

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2.13

Default in Payment Obligations: In addition to all other remedies available to BPS in the event of an NTI default (except in the event of a reasonable, good faith dispute regarding a payment), if NTI fails to make payments as required hereunder, BPS may refuse all further purchase orders, refuse to Produce any Drug Product until NTI’s undisputed account is paid in full, place the account on a letter of credit basis, require full or partial payment in advance, and/or suspend deliveries of Drug Product until NTI provides assurance of payment reasonably satisfactory to BPS.

2.14

Returns: Any Drug Product returned by third parties shall be the responsibility of NTI; provided, however, that NTI may seek damages and/or reimbursement from BPS with respect to such returned Drug Product pursuant to the provisions of Articles 5, 6, 11 and 13, as applicable.

3.1

Term: This Agreement shall commence on the Effective Date and will continue until the Development and Production of all Drug Products, as described in the corresponding Development Plans and Project Plans, have been completed, unless this Agreement is earlier terminated pursuant to Section 3.2 herein (the “Term”).

3.2

Termination: This Agreement may be terminated at any time upon the occurrence of any of the following events:

3.2.1 

Termination At Will by NTI: NTI, in its sole discretion, may terminate this Agreement upon *** days’ prior written notice to BPS, subject to the Cancellation Fee set forth in Section 3.3.

3.2.2 

Termination for Breach: Either party may terminate this Agreement upon the material breach of any provision of this Agreement by the other party, if such material breach is not cured by the breaching party (a) within ten (10) business days for monetary defaults, and (b) for non-monetary defaults, within thirty (30) calendar days (or within such additional time as may be reasonably necessary to cure such non-monetary default, provided the breaching party has commenced a cure within the 30-day period set forth herein, and is diligently pursuing completion of such cure) after receipt by the breaching party of the non-breaching party’s written notice identifying such monetary or non-monetary default and requiring its cure. At the option of the non-breaching party, such

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Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

3.2.3 

Termination for Financial Matters: This Agreement may be terminated immediately by either party upon delivery to the other party of written notice of termination in the event such other party makes a general assignment for the benefit of its creditors, or if proceedings are commenced in any court of competent jurisdiction by or against such party seeking (a) such party’s reorganization, liquidation, dissolution, arrangement or winding up, or the composition or readjustment of its debts, (b) the appointment of a receiver or trustee for or over such party’s property, or (c) similar relief in respect of such party under any law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debt; provided that such termination shall not be effective unless and until such proceedings continue undismissed, or an order with respect to the foregoing is entered and continues unstated, for a period of more than sixty (60) days.

3.2.4 

Cooperation: In the event of termination of this Agreement under Section 3.2.1, 3.2.2 or 3.2.3 above, BPS shall, upon reasonable notice and as reasonably requested by NTI, copy the documentation that is necessary for NTI’s Drug Product regulatory filings ***. BPS shall invoice NTI and NTI shall pay for all reasonable expenses and charges incurred during this process. NTI and BPS shall agree on the reasonable and appropriate amount of time and effort to be expended by BPS pursuant to this Section 3.2.4. BPS shall not be liable for NTI’s loss of use or profits or other collateral, special, consequential or other damages, losses, or expenses, whether such claims are founded in tort or contract, to the extent any such damages, losses, costs, or expenses result directly or indirectly from NTI’s use, interpretation and/or extrapolation of the data, information and records provided by BPS pursuant to this Section 3.2.4.

3.3

Payment on Termination: In the event of early termination of this Agreement by BPS pursuant to Section 3.2 or by NTI pursuant to Section 3.2.1, NTI shall reimburse BPS for (a) all Components ordered prior to termination that are not cancelable or returnable at no cost to BPS, (b) all work-in-process commenced by BPS prior to delivery of the notice of termination, and (c) all finished Drug Product; provided, however, that BPS shall use commercially reasonable efforts to mitigate the costs incurred by NTI pursuant to this sentence. In the event of a cancellation by NTI of the Production of any Batch set forth in an executed Project Plan, NTI shall pay the Cancellation Fees as hereinafter set forth: (x) NTI shall be subject to a charge of *** percent (***%) of the Purchase Price if a Batch is canceled less than nine (9) weeks from the scheduled fill date; (y) NTI shall be subject to a charge of *** percent (***%) of the Purchase Price if a Batch is canceled less than six (6) weeks from the scheduled fill date; and (z) NTI shall be subject to a charge of *** percent (***%) of the Purchase Price if a Batch is canceled less than three (3) weeks from the scheduled fill date. In addition, NTI shall compensate BPS for any materials ordered pursuant to the Project Plan that cannot be canceled or returned, and for any Batch-related testing that has been completed prior to the date of cancellation. For purposes of this Section 3.3, one (1) week is equivalent to seven (7) calendar days. Following expiration or termination of this Agreement, or following NTI’s cancellation

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Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

3.4

Survival: Termination or expiration of this Agreement through any means or for any reason shall be without prejudice to the rights and remedies of either party with respect to any antecedent breach of any of the provisions of this Agreement. The provisions of Articles 6, 9, 10, 11, 12, 13, 14, and 15 and Sections 3.2.4, 3.3 and 5.2(b) hereof shall survive expiration or termination of this Agreement.

4.1

Certificates of Analysis: At NTI’s cost and expense, BPS shall test, or shall cause to be tested by a third party(ies), in accordance with the Specifications, each Batch of Drug Product Produced pursuant to this Agreement before delivery to NTI. A QCMD containing the certificate of analysis for each Batch so Produced shall set forth the items tested, Specifications, and test results. BPS shall also indicate on the final page of the Released Executed Batch Record that all Batch Production and control records have been reviewed and approved by the appropriate quality unit. BPS shall send, or shall cause to be sent, such certificates of analysis to NTI prior to BPS’ shipment of Drug Product (unless Drug Product is shipped under quarantine). Any testing performed by BPS (including tests to confirm that such Batch meets the Specifications) may be used by NTI for final release of each Batch of Drug Product without additional testing by NTI. However, as required by the FDA, NTI shall assume full responsibility for final release of each Batch of Drug Product.

4.2

Manufacturing Compliance: BPS shall advise NTI as soon as practicable (but in any event within forty-eight (48) hours) if an authorized agent of any Regulatory Authority or any regulatory body visits BPS’ manufacturing facility and makes an inquiry regarding BPS’ Production of Drug Product for NTI, and shall provide to NTI copies of any Form 483s or equivalent documents delivered by such Regulatory Authority or regulatory body as a result of such visit as they specifically relate to the Drug Product (including Production of Drug Product), provided however that BPS reserves the right to appropriately redact non-Drug Product-specific information to comply with its obligations of confidentiality to third parties. NTI shall advise BPS as soon as practicable (but in any event within forty-eight (48) hours) if an authorized agent of any Regulatory Authority or any regulatory body plans to visit or accompany NTI on a visit to BPS’ manufacturing facility. Manufacturing exceptions which occur during Production of Drug Product shall not in and of themselves be a basis for rejecting Drug Product as non-conforming; non-conformity shall be determined under Article 5. BPS shall notify NTI as soon as practicable (but in any event within forty-eight (48) hours) of the initiation of any investigation for any level II exceptions.

4.3

Reserve Samples: NTI shall be responsible for obtaining and maintaining sufficient quantities of Bulk Drug Substance reserve samples in accordance with cGMP.

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Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

4.4

Annual Quality Review: NTI shall be responsible for evaluating, at least annually, the quality standards of Drug Product to determine the need for changes in Specifications, manufacturing processes, and/or controlled documents. NTI shall supply BPS a copy of its evaluation and recommendations, if any.