Document:

Exhibit 10.57

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]

 

MASTER PRODUCT DEVELOPMENT AND COLLABORATION AGREEMENT

 

BY AND AMONG

 

RICONPHARMA LLC

 

AND

 

ANIP ACQUISITION COMPANY d/b/a ANI PHARMACEUTICALS, INC.

 

JULY 2011

 

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]

 

This MASTER PRODUCT DEVELOPMENT AND COLLABORATION AGREEMENT is  made as of the 11th day of July 2011, by and among ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware (“ANI”), having a place of business at 210 Main Street West, Baudette, MN 56623 and RiconPharma LLC, a limited liability company having its principal office at 100 Ford Road, Suite #9, Denville, NJ 07834 (“RiconPharma”).  ANI and RiconPharma may each be referred to herein individually as a “Party” and collectively as the “Parties.”

 

WHEREAS, RiconPharma possesses expertise relating to the development of finished dosage forms of pharmaceutical products and ANI possesses expertise relating to the manufacture of finished pharmaceutical products and also possesses expertise relating to the marketing, distribution and sale of pharmaceutical products;

 

WHEREAS, the Parties desire, from time to time, to collaborate in a cost, asset, and profit sharing arrangement for the development, manufacturing, regulatory approval, and marketing of pharmaceutical products in the US and also to invest their respective resources in developing, obtaining regulatory approval for manufacturing and marketing such products in the manner to be set forth in a Amending Product Exhibit hereto (each, a “Amending Product Exhibit”); and

 

WHEREAS, each Amending Product Exhibit shall delineate the specific terms and conditions related to each new Product collaboration including, but not limited to, a description of the Product (hereinafter defined) to be developed, the estimated cost of development, and the percentage allocation of costs and profits; and

 

NOW, THEREFORE, in consideration of the foregoing and of the agreements, representations, covenants, and warranties contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.                                      DEFINITIONS.

 

For the purposes of this Agreement, the following terms shall have the following meanings:

 

1.1                               “Affiliate” shall mean any person, directly or indirectly, controlling, controlled by, or under common control with, another person.  Without limiting the generality of the foregoing, a person is considered to be in control of or to be controlled by another person if such person holds 50% or more of the outstanding voting equity interest in such other person or such other person holds 50% or more of its outstanding voting equity interest.

 

1.2                               “ANDA” shall mean an abbreviated new drug application or similar health registration application that is or will be filed with a Regulatory Authority to obtain Regulatory Approval to market a Product in the Territory.

 

 

1.3                               “API” shall mean an active pharmaceutical ingredient in a Product shipped to ANI.

 

1.4                               “API Suppliers” shall have the meaning set forth in Section 7.2 of this Agreement.

 

1.5                               “Approved Product” shall mean a Product that shall have been granted all necessary approvals by all required Regulatory Authorities sufficient to permit the marketing and sale by ANI or an Affiliate of ANI of such Product in the Territory.

 

1.6                               “Base Price” shall mean the price charged by ANI for a Unit of Product, which price shall be comprised of the cost of Raw Materials, Components, labor, overhead and profit per Unit, which is further described in the Amending Exhibit.

 

1.7                               “Batch” with respect to a Product, shall mean a specific quantity of a Product that is intended to have uniform character and quality within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture, and designated by a batch number.

 

1.8                               “Bioequivalent Product” shall mean with respect to a Product, a drug product that is a bioequivalent, as that term is used in the FDA Orange Book and that is identical in strength or concentration, contains the same active ingredient(s), is in the same dosage form, and utilizes the same route of administration as the Product.

 

1.9                               “Bioequivalence Study” shall have the meaning set forth in Section 3.1 of this Agreement.

 

1.10                        “Calendar Quarter” shall mean the periods of three consecutive calendar months ending on March 31, June 30, September 30 or December 31.

 

1.11                        “Certificate of Analysis” shall mean a document, which is dated and signed by a duly authorized representative of the quality control or quality assurance department of ANI, certifying that a Batch of any Product meets all Specifications accompanied by the certificate(s) of analysis prepared and signed by any manufacturer(s) of the Product(s) in the Batch and Raw Materials for the Product in the Batch certifying that the Products and Raw Materials meet all applicable specifications.

 

1.12                        “Claim” shall have the meaning set forth in Section 17.5 of this Agreement.

 

1.13                        “Commercially Reasonable Efforts” with respect to the efforts to be expended by a Party regarding any objective under this Agreement, shall mean reasonable, diligent, good-faith efforts to accomplish such objective as a reasonable person or entity similarly situated would normally use to accomplish a similar objective under similar circumstances exercising reasonable business judgment.

 

 

1.14                        “Components” shall mean all labels, bottles, caps, seals, cardboard packaging, inserts and other materials (excluding Raw Materials) used to Label and package a Unit for shipment to ANI.

 

1.15                        “Confidential Information” shall have the meaning set forth in Section 21 of this Agreement.

 

1.16                        “Continuing Party” or “Continuing Parties” shall have the meaning set forth in Section 20.6 of this Agreement.

 

1.17                        “Cost of Goods” shall mean the total amount contingently charged by ANI for the purchase of Products during any Calendar Quarter, each Unit invoiced at the Base Price.

 

1.18                        “Development Costs” shall mean the costs incurred by the Parties in developing a Product, including but not limited to costs of formulation development, analytical development, scale-up, demo batches, bio-batch manufacturing, ICH Stability packaging and testing, bioequivalence studies, and ANDA filings.

 

1.19                        “Development Cost Percentage” shall mean the percentage of Development Costs allocated to each Party in connection with developing Products and as set forth in the Amending Product Exhibit.

 

1.20                        “DMF” shall mean the drug master file, confidential or otherwise, covering the manufacture and analysis of an API with respect to a Product in the Territory.

 

1.21                        “EDC” shall have the meaning set forth in Section 3.2.

 

1.22                        “Effective Date” shall mean the date of execution by the Parties of the first Amending Product Exhibit to this Agreement.

 

1.23                        “FDA” shall mean the United States Food and Drug Administration, or any successor agency.

 

1.24                        “FD&C Act” shall mean the Federal Food, Drug and Cosmetic Act of 1938, as amended, and the regulations thereunder, as the same may be amended from time to time.

 

1.25                        “Good Clinical Practices” or “GCPs” shall mean the then-current standards for clinical trials for pharmaceuticals as set forth in the FD&C Act and applicable regulations promulgated thereunder.

 

1.26                        “Good Laboratory Practices” or “GLPs” shall mean the then-current standards for laboratory activities for pharmaceuticals as set forth in the FD&C Act and applicable regulations promulgated thereunder.

 

 

1.27                        “Good Manufacturing Practices” or “GMPs” shall mean the then-current standards for the manufacture of pharmaceutical Products as set forth in the FD&C Act and applicable regulations promulgated thereunder.

 

1.28                        “Indemnity Claim” shall have the meaning set forth in Section 17.5 of this Agreement.

 

1.29                        “Initial Marketing Date” shall be the date listed on the FDA Form 2657 (New Product Listing Form) or its successor, indicating the first date a Product is distributed to customers in the Territory.

 

1.30                        “Invention(s)” shall mean an invention conceived and reduced to practice in the course of the performance of and within the scope of this Agreement.

 

1.31                        “Know-How” shall mean all proprietary technical and clinical information, data and know-how relating to a Product, whether or not patentable, which is owned or controlled as of the Effective Date or acquired or developed during the term of this Agreement by a Party hereto.  Know-How shall include, without limitation, processes, formulas, discoveries and inventions whether relating to biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical safety, quality control and clinical data.  The term “Know-How” shall exclude:  (i) processes, information and data which is, as of the Effective Date, generally available to the public or later becomes generally available without breach by a Party of its obligations of confidentiality hereunder; or (ii) any general development or manufacturing know-how not specific to a Product.

 

1.32                        “Label” and “Labeling” have the meaning given those terms by 21 CFR Part 201.

 

1.33                        “Litigation Expenses” shall mean expenses incurred in investigating, defending, or litigating any claims, demands, or actions related to a Product made or brought by a Third Party (including reasonable legal fees and the payment of damages and expenses to a Third Party).

 

1.34                         “Manufacturer and Development Technology” shall mean all information, data, intellectual property and Know-How, whether patentable or not, which is owned or controlled by ANI or RiconPharma prior to or during the Term and which is necessary or useful in developing and manufacturing Products, in developing and conducting Bioequivalence Studies for the Products, in preparing and filing Regulatory Approvals for the Products and in maintaining such Regulatory Approvals.

 

1.35                        “Net Profits” shall, with respect to any Product, Net Sales less Base Price in respect of such Product.

 

1.36                        “Net Sales” shall mean the gross amounts invoiced by ANI for any Product sold to third less the sum of chargebacks, cash and quantity discounts, returns, rebates and such other credits granted by ANI or taken by customers with respect to such

 

 

Product sales. Net Sales shall be determined in accordance with generally accepted accounting principles using the accrual method of accounting, consistent with historical practices of ANI.  The sum of chargebacks, cash and quantity discounts, returns, rebates and such other credits will not exceed [ *** ] of gross amounts invoiced without the consent of both ANI and RiconPharma.

 

1.37                        “Non-Continuing Party” or “Non-Continuing Parties” shall have the meaning set forth in Section 20.6 below.

 

1.38                         “Party” shall mean either ANI or RiconPharma and “Parties” shall mean two or more of the following as the context dictates:  ANI and RiconPharma.

 

1.39                        “Phase(s)” shall have the meaning set forth in the Amending Product Exhibit of any Products in this Agreement.

 

1.40                        “Policy” shall have the meaning set forth in Section 18.1 of this Agreement.

 

1.41                        “Product(s)” shall mean the Product(s) set forth in each Amending Product Exhibit.

 

1.42                        “Product Action” shall have the meaning set forth in Section 11.2 of this Agreement.

 

1.43                        “Profit Sharing Percentage” shall mean the percentage of Net Profits allocated to each Party with respect to each Product as set forth in each Amending Product Exhibit to this Agreement for that Product.

 

1.44                        “Raw Materials” shall mean the API and inactive ingredients used to manufacture a Product.

 

1.45                        “Recall” shall have the meaning set forth in Section 11.1 of this Agreement.

 

1.46                        “Records” shall have the meaning set forth in Section 19.1 of this Agreement.

 

1.47                        “Reference Product” shall mean the product currently marketed and sold under the pharmaceutical brand identified in the Amending Product Exhibit.

 

1.48                        “Registration”,  with respect to a Product, shall mean the meeting of all of the requirements of all applicable Regulatory Authorities necessary to permit the commencement of marketing and selling such Product in the Territory by ANI or an Affiliate of ANI.

 

1.49                        “Regulatory Approval” shall mean the authorizations and approvals of any Regulatory Authority (including, without limitation, approvals of ANDAs and NDAs) required for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Product(s) in the Territory.

 

 

1.50                        “Regulatory Authority” shall mean any and all bodies and organizations regulating the manufacture, importation, marketing, distribution, use and sale of any of the Products in the Territory.

 

1.51                        “Retaining Party” shall have the meaning set forth in Section 19.3 of this Agreement.

 

1.52                        “Sales and Marketing Company” shall have the meaning set forth in Section 2.1 of this Agreement.

 

1.53                        “SIR” shall have the meaning set forth in Section 18.1 of this Agreement.

 

1.54                        “Specifications” shall mean the specifications for each Product as agreed to by the Parties and as approved by the applicable Regulatory Authority, which Specifications may be amended from time to time by written agreement between the Parties and as specifically requested by the applicable Regulatory Authority.

 

1.55                        “Term” shall have the meaning set forth in Section 20.1 of this Agreement.

 

1.56                        “Territory” shall mean the United States of America.

 

1.57                        “Third Party” shall mean any person or entity other than a Party or any of its Affiliates.

 

1.58                        “Trademark” means the trade name and/or trademark used and owned by a Party.

 

1.59                         “Unit” shall have the meaning set forth in the Amending Product Exhibit.

 

2.                                      THE COLLABORATION.

 

2.1                               The Parties agree to collaborate in the selection of Products and in the development, manufacturing, registration and approval, and marketing of such Products as set forth in more detail in this Agreement and any applicable Amending Product Exhibit.  Unless otherwise specified in an Amending Product Exhibit, RiconPharma will be responsible for developing the Products and ANI will be responsible for manufacturing and distribution of the Products in the Territory.  The Parties shall be jointly responsible for directing any bioequivalence studies and obtaining Regulatory Approval for such pharmaceutical products, and ANI shall be responsible for maintaining such Regulatory Approvals.  ANI or a separate sales and marketing company designated by ANI (a “Sales and Marketing Company”) will be primarily responsible for the marketing, distribution and sale of the Products as well as customer service, rebate management, billing, warehousing and such other responsibilities as are regularly performed by a pharmaceutical distributor.

 

 

2.2                               The Parties shall jointly own all the rights, title, and interest in the Products (including without limitation, the ANDA for the Products).  The respective percentages of ownership for each Product shall be one-half for each Party unless a different percentage is set forth in the Amending Product Exhibit for that Product.  Subject to Section 2.3, neither Party, without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed, may:  (i) assign this Agreement; (ii) sell or assign its ownership rights to a Product to a Third Party; or (iii) license or assign any other right, title, or interest in a Product.

 

2.3                               In the event of a sale of more than 50% of a Party’s total assets, as reflected in the Party’s most recent annual financial statements, that Party may assign this Agreement or sell or assign its ownership rights to a Product without the prior written consent of the other Party.  It is understood that any successor company, either through assignment or acquisition of the ownership rights from any Party, shall be bound by the terms and conditions contained within this Agreement.

 

2.4                               ANI or a Sales and Marketing Company designated by ANI shall have the exclusive rights to market, distribute, offer for sale, and sell Products in the Territory during the Term of this Agreement.

 

2.5                               True and complete copies of any Party’s agreements with any Third Party or Affiliate for the manufacture or supply of any Product, Raw Materials or Components shall be attached as exhibits to this Agreement simultaneously with the delivery of an Amending Product Exhibit contemplating the inducement of such Third Party or Affiliate.

 

2.6                               The Parties hereby appoint ANI as an Authorized Distributor of Record (“ADR”) for all Products under this Agreement, and authorize ANI to designate additional ADRs on behalf of ANI for all Products.

 

 

3.                                      DEVELOPMENT.

 

3.1                               RiconPharma shall be responsible for developing the Products, including, but not limited to, development of the Products, formulations, analytical methods, and the performance and coordination, including oversight, of any necessary clinical studies with ANI to determine if such Products are Bioequivalent to the Reference Products.  Such clinical studies shall be conducted by Third Party contract research organizations selected by the Parties (each, a “Bioequivalence Study”).  If a Bioequivalence Study does not demonstrate that the formulations developed by RiconPharma are bioequivalent to the Reference Products, and if the Parties determine that an additional Bioequivalence Study is advisable, then RiconPharma shall reformulate the Products for use in additional Bioequivalence Studies and any actual additional documented costs specifically attributed to the reformulation shall be shared by the Parties according to each Party’s Development Cost Percentage set forth in the Amending Product Exhibit.

 

3.2                               Development Costs for each Phase of a Product will be as set forth in the Amending Product Exhibit for that Product, and shall be shared by the Parties in accordance with each Party’s Development Cost Percentage for that Product.  Subject to Section 3.5, if a Party actually incurs Development Costs during a Phase in excess of that Party’s share of Development Costs for the Phase (the “EDC”), the other Party shall, to the extent not already paid, reimburse that Party its respective share of the EDC within thirty (30) days after receipt by the other Party of written notice from the Party requesting reimbursement.  Each notice must include the amount requested and the written support for the EDC.

 

3.3                               For each Product, RiconPharma shall use its Commercially Reasonable Efforts to complete each Phase of development by the Completion Date for that Phase indicated in the Amending Product Exhibit for that Product.

 

3.3.1                     Without limitation, RiconPharma will be responsible for all development functions (e.g. pre-formulations, formulations and analytical method development, technology transfer and scale-up support), and will provide necessary support in obtaining Regulatory Approval for such Products, and all such other responsibilities as are typically undertaken by a company engaged in pharmaceutical development.

 

3.3.2                     Without limitation, ANI will be responsible for manufacturing the scale-up and demo batches, ICH stability testing, CMC, Biobatches, ANDA submissions, validations and all such other responsibilities as are typically undertaken by a company engaged in pharmaceutical manufacturing.

 

3.3.3                     Without limitation, ANI or a Sales and Marketing Company designated by ANI will be responsible for sales, marketing and distribution and all such other responsibilities as are typically undertaken by a company engaged in pharmaceutical distribution.

 

 

3.4                               For each Product, RiconPharma will provide ANI with written notice of the completion of each Phase of development set forth in the Amending Product Exhibit for that Product and ANI will have ten (10) business days after the receipt of such notice within which to notify RiconPharma of any termination of that Amending Product Exhibit as provided in Section 20.4.

 

3.5                               No Party shall have any obligation to reimburse the other Party for any portion of expenses incurred by a Party in excess of 105% of the anticipated Development Costs set forth in an Amending Product Exhibit unless such excess expenses have been approved, in writing, by all Parties prior to the time they are incurred

 

3.6                               In the event that the Parties mutually agree to accept payment from a Third Party in exchange for not developing, manufacturing or marketing a Product, such payment shall be shared by the Parties in accordance with each Party’s Profit Sharing Percentage set forth in the Amending Product Exhibit.

 

4.                                      COMMERCIALIZATION.

 

4.1                                       The Parties may market the Products under a trade name which ANI or a Sales and Marketing Company designated by ANI shall have the right to select, subject to the approval of both Parties, which approval will not be unreasonably withheld, conditioned or delayed.  ANI shall own all trade names.  The costs of searching, selecting, registering and enforcing a trade name for a Product, if any, shall be advanced by ANI.  ANI shall be responsible for responding to regulatory inquiries relating to any trade names selected hereunder.

 

4.2                               All Products sold by ANI shall bear the ANI Trademark and the applicable ANI NDC number and labeler code.  To the extent permitted by applicable law and regulations, ANI shall be identified on the Product packaging as the manufacturer of the Products and ANI shall be identified on the Product packaging as the labeler/distributor of the Product.

 

4.3                               ANI agrees that at all times during the Term, neither it nor any of its Affiliates will develop, manufacture, sell or distribute a product that is the same as a Product or a product that is a Bioequivalent Product of a Product in the Territory unless RiconPharma approves in writing.

 

4.4                               RiconPharma agrees that at all times during the Term, neither it nor any of its Affiliates will develop, manufacture, sell or distribute a product that is the same as a Product or a product that is a Bioequivalent Product of a Product in the Territory unless ANI approves in writing.

 

4.5                               All Parties may manufacture, distribute, promote, and sell products in the Territory other than (i) the Products, (ii) Bioequivalent Products of the Products, or (iii) a product that is the same as a Product, and may acquire such products from Third Party manufacturers.

 

 

4.6                               ANI shall consult with RiconPharma and determine the price at which it shall sell the Products in the Territory.  ANI shall have sole discretion over the pricing, marketing, and sales of Products in the Territory including, but not limited to, marketing strategy, sales strategy, Product placement, Product distribution, the terms of sale of Products, and decisions whether to accept returns on Products from the Territory.

 

4.7                               ANI shall at all times maintain a ninety (90) day rotating inventory of API and Components for all Products covered by an Amending Product Exhibit not terminated pursuant to Section 20.

 

4.8                               ANI and RiconPharma shall promptly provide or make available for review all testing documentation, material safety data sheets, certificates of analysis and all similar materials as reasonably requested by its Customers.

 

5.                                      SHARING OF NET PROFITS.

 

5.1                               Net Profits from the sale of a Product will be shared by the Parties in accordance with each Party’s Profit Sharing Percentage set forth in the Amending Product Exhibit.

 

5.2                               Within thirty (30) days after the end of each Calendar Quarter, ANI shall calculate the Net Sales and the Net Profits obtained from the sale of Products during such Calendar Quarter and shall distribute to RiconPharma its Profit Sharing Percentage of such Net Profits.  ANI shall supply RiconPharma with a written report setting forth the Net Sales and Net Profits during such Calendar Quarter.  If the Net Profits related to a Product for any Calendar Quarter is negative, then ANI may invoice RiconPharma for such amount due to ANI in accordance with this Agreement and in proportion to each Party’s Profit Sharing Percentage of such quarterly loss, such payment to be made within thirty (30) days of such invoice.

 

6.                                      TAXES AND WITHHOLDING.

 

All payments under this Agreement shall be made without any deduction or withholding for or on account of any tax unless such deduction or withholding is required by applicable laws or regulations.  If the paying Party is so required to deduct or withhold, such Party shall:  (i) promptly notify the Party entitled to receive such payment of such requirement; (ii) pay to the relevant authorities the full amount required to be deducted or withheld promptly upon the earlier to occur of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against the Party entitled to receive such payment; and (iii) promptly forward to such other Party an official receipt (or certified copy) or other documentation reasonably acceptable to such other Party evidencing such payment to such authorities.  Unless otherwise required by law, each Party shall be responsible for the calculation and payment of its own taxes.

 

 

7.                                      REGULATORY APPROVAL AND REGISTRATIONS.

 

7.1                               ANI shall be responsible for obtaining all Regulatory Approvals for the Products necessary for the Registration of such Product in the Territory including the preparation of all ANDAs for the Products.  ANI shall prepare all documents such as CMC and perform all other work necessary to obtain Regulatory Approvals and Registration of the Products in the Territory.  The Parties will support the ANDA filing and help in obtaining Regulatory Approval for such Products, including, without limitation:

 

(a)                                 seeking all necessary approvals to permit the conduct of Bioequivalence Studies using the Products;

 

(b)                                 seeking all necessary Regulatory Approvals and Registrations from the appropriate Regulatory Authority in the Territory to manufacture, distribute, market and sell each of the Products in the Territory;

 

(c)                                  preparing other applicable filings and obtaining approvals in connection with its advertising and promotional materials related to each of the Products; and

 

(d)                                 the quality control testing of all Raw Materials used in the manufacture of each of the Products in accordance with the standards of the United States Pharmacopeia and any other specification which may be required by a Regulatory Authority;

 

(e)                                  the pharmacokinetic and stability tests of the Products and the manufacture and scale-up of exhibit and registration stability Batches of the Products;

 

(f)                                   the conduct of ongoing stability trials as required by any Regulatory Authority in the Territory; and

 

(g)                                  the preparation and completion of any additional documentation necessary for the Registration of the Products in the Territory.

 

7.2                               RiconPharma shall provide ANI with the identities of Raw Material sources including sources for the supply of approved APIs for the Products (“API Suppliers”).  ANI will ensure that API Suppliers have maintained and, if required, filed appropriate DMFs in respect of the APIs used in the Products.

 

7.3                               The testing and studies referred to in Sections 3.1 and 8.1 shall be conducted in accordance with all applicable GLPs and with all reasonable diligence.  The Parties shall jointly review and comment upon, prior to submission, any documents submitted to any Regulatory Authority pertaining to the testing and study of a Product described in Sections 3.1 and 8.1 and DMFs covering any API in any Product.

 

 

7.4                               No Party may attempt to modify the ANDA for a Product after Regulatory Approval in any way without the consent of the other Party.

 

7.5                               Each Party shall immediately notify the other Party of any (a) inspections by any Regulatory Authority, including, without limitation, inspections as a result of the recall of, or any other regulatory issue related to, any of the Products and/or (b) material notices received from any Regulatory Authority.  Each Party shall immediately notify the other Party if it becomes aware of any concern with respect to any Product that may affect the efficacy or safety of any of the Products.

 

8.                                      MANUFACTURE AND SUPPLY OF THE PRODUCTS, QUALITY CONTROL.

 

8.1                               ANI shall ensure that all Products supplied will be manufactured and packaged in accordance with GMPs and will conform to the Specifications, the applicable Regulatory Approval(s), and other regulations and requirements of the Regulatory Authorities.

 

8.2                               ANI shall perform, or ensure the performance of, release testing of Products in a manner consistent with GMP testing methods agreed upon by the Parties as set forth on the Specifications.  ANI shall provide RiconPharma with a Certificate of Analysis with each shipment of the Products stating that the Products in that shipment conform to the Specifications.  ANI will ensure that a copy of the Certificate of Analysis with respect to each Batch of Product supplied (a) is faxed prior to shipping such Batch (confirmed by hard copies mailed) and (b) accompanies each Batch.  ANI shall not ship any Batch of the Product if such Batch does not conform to the Specifications.

 

8.3                               ANI shall ensure that each Batch of the Product is labeled and that each of the Batch numbers is applied to each such Batch, as required by the Regulatory Authorities.

 

8.4                               ANI shall provide and maintain suitable storage and transport conditions for all Products shipped and shall provide complete written instructions with respect to proper conditions for the transport and storage of the Product.  Upon receipt of any Batch of the Product from ANI, a Sales and Marketing Company shall provide and maintain storage conditions that comply with any written instructions provided by ANI in respect of the storage of Product.

 

9.                                      PACKAGING AND LABELING.

 

ANI shall package and Label the Products shipped under this Agreement or ensure that such Products are packaged and Labeled in strict compliance with the Specifications and the packaging and Labeling requirements of the Regulatory Authorities.  ANI shall be responsible for the accuracy and content of the Labeling.

 

 

10.                               REGULATORY REPORTING AND COMPLIANCE

 

10.1                        Regardless of which Party or Parties hold the ANDA, ANI shall have the sole responsibility for monitoring and ensuring the material compliance with all statutes, regulations, guidelines and other requirements of the Regulatory Authorities pertaining to the Products, the Registration, and/or the Regulatory Approval.  ANI shall be responsible for ensuring appropriate work is performed with respect to supplementing or amending the approved ANDA and for complying with all reporting requirements relating to the Products and the Regulatory Approvals.  Those duties include, without limitation, responding to physician questions regarding the Products and the submission of annual reports and adverse drug experience reports for the Products to the Regulatory Authority and the performance of all due diligence with respect to any adverse drug experience reports.

 

10.2                        If RiconPharma receives a report or any other information regarding an adverse drug experience attributed to a Product, it shall promptly provide ANI with all such information.  If either Party receives a communication from the Regulatory Authority regarding a Product, it will promptly notify the other Party in writing about that communication and shall provide a copy thereof.  Upon request both ANI and RiconPharma shall provide each other with any other information they have or receive, if any, that ANI reasonably requires to comply with its obligations under Section 10.1.

 

10.3                        Subject only to the specific duties imposed by Section 10.2, RiconPharma shall have no duties or responsibilities of any kind with respect to reporting to the Regulatory Authority or monitoring or ensuring compliance with any requirements of the Regulatory Authority.

 

11.                               RECALLS AND OTHER PRODUCT ACTIONS

 

11.1                        Each Party shall promptly notify the other Party in writing of any order, request or directive of the Regulatory Authority or an order of a court to recall or withdraw a Product anywhere in the Territory (hereinafter “Recall”).  The Party in whose name the ANDA is held shall be responsible for coordinating all communication in connection with the Recall, including all coordination and communications with the Regulatory Authority.

 

11.2                        In the event that a Party believes it may be necessary to conduct a voluntary recall, field correction, market withdrawal, stock recovery or other similar action (hereinafter “Product Action”) with respect to any Product which was sold under this Agreement, such Party shall promptly consult with the other Party in good faith as to how best to proceed, it being understood and agreed that no Party shall be prohibited hereunder from taking any action that it is required to take by applicable law.

 

 

11.3                        In the case of a Recall or Product Action, each Party shall make a permanent, complete and accurate record of all costs incurred by it in connection with the Recall or Product Action, a copy of which shall be delivered to the other Party as soon after the completion of such Recall or Product Action as may be practicable.

 

11.4                        In the case of a Recall or Product Action that is covered by a recall insurance policy held by any Party, the Party holding the recall insurance policy shall be fully reimbursed the deductible amount in equal proportion by the Parties in accordance with the Profit Sharing Percentage for that Product.  In the event that the recall expenses exceed insurance coverage, the Parties shall, except in the case of a Recall or Product Action that is covered by an indemnity obligation, share the expenses in accordance with the Profit Sharing Percentage for that Product.

 

11.5                        In the case of a Recall or Product Action that is not covered by any indemnity obligation of a Party under Section 17 of this Agreement, the costs incurred by the Parties in connection with the Recall or Product Action shall be shared by the Parties in accordance with the Profit Sharing Percentage for that Product.  In that event, if one Party has paid more than its share of the costs in connection with the Recall or Product Action, the other Parties, in accordance with their Profit Sharing Percentage for that Product, shall reimburse the overpaying Party the amount of the overpayment within sixty (60) days of receiving the record contemplated by Section 11.3.

 

12.                               ORDERS AND DELIVERY OBLIGATIONS.

 

12.1                        The manufacturing Batch size of the Product that shall be listed on the corresponding Amending Product Exhibit.  ANI or a Sales and Marketing Company designated by ANI shall accept orders for full-Batch quantities of the Product at the Base Price, as set forth in the corresponding Amending Product Exhibit.

 

12.2                        The Amending Product Exhibit will set forth the Base Price for each Product.  The Base Price may change from time to time based on the actual changes in the cost of Raw Materials, Components, labor, overhead, and costs related to stability testing and regulatory support services.  ANI shall provide, at RiconPharma’s request, documentation illustrating how such Base Price changes have been calculated prior to the implementation of such change.  Notwithstanding any other provision in this Agreement, ANI may not increase the labor and overhead elements of the Base Price calculation greater than [ *** ] without the express advance written consent of ANI and RiconPharma, which consent shall not be unreasonably withheld, conditioned or delayed.

 

13.                               RECORDS.

 

13.1                        ANI will maintain records and documents documenting the Base Price of each Product and ANI will maintain records and documents documenting Net Sales

 

 

and all transactions relating to the sale of each Product for a time period equal to the greater of:

 

(a)                                 the period meeting all known regulations of the applicable Regulatory Authorities with respect to such Product; and

 

(b)                                 five (5) years from the date of sale.

 

13.2                        ANI shall maintain all records relating to the manufacture of the Products necessary to materially comply with all applicable laws, rules and regulations in each regulatory jurisdiction within the Territory and, if different, the regulatory jurisdiction of manufacture of the Products.  Specifically, but without limitation, ANI shall maintain all records and samples (including retention samples) reasonably necessary to support GMPs and other regulatory requirements in such regulatory jurisdictions.  All records relating to the manufacture of the Product shall be available for inspection, audit and copying by RiconPharma and its representatives and agents at ANI’s office upon reasonable advance request and during normal business hours.  All such records shall be maintained for a period of not less than three (3) years or such longer period as may be required by law, rule or regulation.  All records relating to the manufacture, stability and quality control of each Product shall be retained for a period of not less than the approved shelf life of such Product as set forth in the related Regulatory Approval plus two (2) years.

 

13.3                        RiconPharma shall maintain all records relating to the development of the Products necessary to materially comply with all applicable laws, rules and regulations in each regulatory jurisdiction within the Territory.  All records relating to the development of each Product shall be available for inspection, audit and copying by ANI and its representatives and agents at RiconPharma’s office upon reasonable advance request and during normal business hours.  All such records shall be maintained for a period of not less than the period the Product is sold is by ANI or such longer period as may be required by law, rule or regulation.

 

14.                               INTELLECTUAL PROPERTY RIGHTS.

 

14.1                        Each Party shall own all Inventions made solely by its employees and agents, and all patent applications and patents claiming such Inventions.  All Inventions made jointly by employees or agents of the Parties and all patent applications and patents claiming such Inventions shall be owned jointly by the Parties.  All determinations of invention under this Section 14 shall be in accordance with U.S. law

 

14.2                        The Party owning the Invention shall make all decisions with respect to patent filings and shall have the right to select patent counsel and to take such other actions as are necessary to prepare, file, prosecute and maintain patent protection with regard to the Inventions under Section 14.1.  With regard to jointly owned

 

 

Inventions, the Parties shall jointly determine in what countries, if any, patent applications claiming such joint Inventions should be filed.  In the event that either Party does not wish to share in the expenses of filing, prosecuting or maintaining such joint Inventions in any country, such Party shall promptly assign or cause to be assigned to the other Party all of its right, title and interest in and to such joint Inventions in the subject country.  Thereafter, such joint Invention shall be treated as an Invention solely owned by such other Party within the subject country for all purposes of this Agreement.  In the event the Parties desire to proceed with the filing, prosecution and maintenance of such joint invention, they shall share in all expenses related thereto in accordance with each Party’s Development Cost Percentage on the Amending Product Exhibit for the Product to which the Invention relates or most closely relates.

 

14.3                        Each Party shall be responsible for prosecuting and maintaining its own patent applications and patents.  Except as otherwise provided in Section 14.2, all expenses for filing, prosecuting and maintaining a Party’s patent applications and patents shall be borne by such Party.

 

14.4                        Each Party shall execute such documents as may be necessary to obtain, perfect or maintain any jointly owned patent rights filed pursuant to this Agreement.  The Parties agree to cooperate with one another so far as reasonably necessary with respect to furnishing all information and data in its possession reasonably necessary to obtain or maintain such jointly owned patent rights.

 

14.5                        Each Party shall have the sole right, in its own name and at its own expense, to enforce patent rights relating to Inventions that it owns against any Third Party.  The Parties shall jointly determine which Party shall have the right and responsibility to institute, prosecute and control any action or proceeding with respect to the infringement or misappropriation of jointly owned patent rights.

 

14.6                        In connection with any action taken by either Party against a Third Party to protect or enforce any patent right hereunder, the other Party shall, if requested, consult with the Party taking such action, and make its employees available as witnesses or as evidence any materials and/or data reasonably necessary for the furtherance of such action.  Expenses incurred in connection with providing witnesses and/or making materials or data available shall be borne by the Party taking action against the Third Party.

 

14.7                        If a Party is sued for infringing any Third Party patent out of the manufacture, use, sale or importation of a Product in the Territory, the Parties shall promptly discuss the course of action to be taken to resolve or defend such litigation.  Each Party shall provide the other Parties with such assistance as is reasonably necessary and shall cooperate in the defense of such action.

 

 

15.                               RELATIONSHIP OF RICONPHARMA AND ANI.

 

15.1                        The relationship of RiconPharma and ANI created by this Agreement is that of developer and contract manufacturer, and not that of a partnership, principal and agent, franchisor and franchisee, or joint or co-ventures.  In the performance of this Agreement, no Party shall have any authority to assume or create any obligation or responsibility, either expressed or implied, on behalf of or in the name of any other Party, or to bind any other Party or its Affiliates in any manner whatsoever.

 

15.2                        If this Agreement is terminated for any reason, the Parties shall not thereafter use, or permit anyone else under its control to use, any other Party’s name in the promotion of its business or the offer for sale of any goods.

 

16.                               REPRESENTATIONS AND WARRANTIES.

 

16.1                        Each Party hereby represents and warrants to the other Parties that:

 

(a)                                 it is a corporation or other entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or organization;

 

(b)                                 the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate or other entity action and does not require any shareholder or member action or approval;

 

(c)                                  it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;

 

(d)                                 the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under:  (i) a loan agreement, guaranty, financing agreement, agreement affecting a Product or other agreement or instrument affecting a Product; (ii) the provisions of its charter or other operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;

 

(e)                                  it has the full right, power and authority to grant all of the right, title and interest in the licenses, if any, granted to the other Party under this Agreement;

 

(f)                                   it is financially solvent and has the financial resources to perform its obligations under this Agreement; and

 

(g)                                  it is not debarred under the Generic Drug Enforcement Act of 1992; it does not and will not use in any capacity the services of any person

 

 

debarred under the Generic Drug Enforcement Act of 1992; and neither it nor any of its employees, agents, suppliers, or contractors has engaged in any activity which could lead to it becoming debarred under the Generic Drug Enforcement Act of 1992.

 

16.2                        ANI covenants, represents, and warrants that:

 

(a)                                 it shall at all times comply with all material applicable laws, rules, and regulations relating to its activities under this Agreement;

 

(b)                                 all Products shipped shall be manufactured, packaged, stored, and shipped by ANI materially in accordance with all GMPs and all other applicable laws, rules and government regulations in effect at the time of shipping of the Product;

 

(c)                                  the Labeling content for the Products will at all times comply with the Regulatory Approval for the Product and be the same as the Labeling for the Reference Product except for differences allowed by applicable regulations;

 

(d)                                 all Products shipped shall conform to the Specifications, the Regulatory Approval, and the Registration and be merchantable and shall not be misbranded or adulterated;

 

(e)                                  it shall take all commercially reasonable precautions customary in the industry in manufacturing, testing, packaging, labeling and handling the Products to ensure the quality, safety and fitness thereof;

 

(f)                                   that each Unit of the Products shall bear an expiration date of no less than twenty-four (24) months following the date of its manufacture, unless the RLD has an expiration date of less than twenty-four (24) months, in which case the expiration date borne by the Products shall reflect the stability of the RLD;

 

(g)                                  it shall materially comply with all requirements of the laws and regulations of the Regulatory Authority and applicable state law requirements governing the marketing, sale and distribution of Products;

 

(h)                                 it shall maintain adequate warehousing, distribution facilities, documentation and personnel to provide reasonable distribution, staffing for customer service, billing, marketing and accounting with respect to the Products; and

 

(i)                                     copies of all agreements ANI has with any Third Party or Affiliate for manufacture or supply of any Product, Raw Materials or Components in effect on the date hereof are attached as exhibits to this Agreement and the copies attached as exhibits are true and complete copies of those agreements.

 

 

16.3                        RiconPharma covenants, represents, and warrants that:

 

(a)                                 it shall at all times comply with all applicable laws, rules, and regulations relating to its activities under this Agreement;

 

(b)                                 based on its preliminary analysis, RiconPharma believes that Commercially Reasonable Efforts will result in the ability to develop and manufacture and obtain Regulatory Approval for the Products;

 

(c)                                  all of the research and development activities pertaining to the Products shall be conducted in accordance with all applicable laws and regulations, GMPs, GLPs and GCP and all applicable guidelines promulgated by any Regulatory Authority having jurisdiction over the Products in the Territory;

 

(d)                                 copies of all agreements RiconPharma has with any Third Party or Affiliate for manufacture or supply of any Product, Raw Materials or Components in effect on the date hereof are attached as exhibits to this Agreement and the copies attached as exhibits are true and complete copies of those agreements.

 

17.                               INDEMNIFICATION

 

17.1                        RiconPharma shall indemnify, defend, and hold harmless ANI and its respective Affiliates, directors, officers, owners, employees, and agents from and against any and all claims, demands, lawsuits, causes of action, actions or other proceedings, losses, liabilities, injuries, damages, and expenses, including reasonable attorneys’ fees and costs from any actual or alleged infringement of patent, trademark, trade dress or other intellectual property rights or interests of any Third Party by the Products, the sale of the Products and/or the development of the Products.  The indemnity obligations in the preceding sentence shall not apply to an actual infringement caused solely by the willful misconduct of ANI.

 

17.2                        ANI shall indemnify, defend, and hold harmless RiconPharma and their respective Affiliates, directors, officers, owners, employees, and agents from and against any and all claims, demands, lawsuits, causes of action, actions or other proceedings, losses, liabilities, injuries, damages, and expenses, including reasonable attorneys’ fees and costs from any actual or alleged infringement of patent, trademark, trade dress or other intellectual property rights or interests of any Third Party by the Labeling of the Products and/or the methods, design, or processes utilized in connection with the manufacturing or packaging of the Products.  The indemnity obligations in the preceding sentence shall not apply to an actual infringement caused solely by the willful misconduct of RiconPharma.

 

17.3                        RiconPharma shall indemnify, defend, and hold harmless ANI and their respective Affiliates, directors, officers, employees, owners and agents from and against any and all claims, demands, lawsuits, causes of actions, actions or other

 

 

proceedings (including voluntary and involuntary Product Recalls, Product Actions, and other FDA enforcement actions), losses, liabilities, injuries, damages and expenses, including reasonable attorneys’ fees and costs arising from or relating to: (i) the breach of any representation, warranty or covenant made or given by RiconPharma in this Agreement; (ii) any breach of any obligations under Section 10 of this Agreement; (iii) the design or formulation of any Products including, but not limited to, any defect in design, whether patent or latent; and/or (iv) any negligent act or omission by RiconPharma or its Affiliates.

 

17.4                        ANI shall indemnify, defend, and hold harmless RiconPharma and its respective Affiliates, directors, officers, employees, owners and agents from and against any and all claims, demands, lawsuits, causes of actions, actions or other proceedings (including voluntary and involuntary Product Recalls, Product Actions, and other FDA enforcement actions), losses, liabilities, injuries, damages and expenses, including reasonable attorneys’ fees and costs arising from or relating to: (i) the breach of any representation, warranty or covenant made or given by ANI in this Agreement; (ii) any defect in Raw Materials or Components that ANI knew or reasonably should have known through testing in compliance with GMPs, including, but not limited to, any defect from or relating to the handling, storage, formulation, testing, supply, packaging, purchase, or manufacture of any Raw Materials or Components; (iii) the handling or storage by ANI of any Products; (iv) the manufacture, testing, or packaging of any Products including, but not limited to, any defect in manufacturing; (v) the Labeling of the Products including, but not limited to, any defect in warning; and (vi) any grossly negligent act or omission by ANI or its Affiliates.

 

17.5                        A Party shall give written notice to the other Party of a claim, demand, lawsuit, cause of action, action or other proceeding (including voluntary and involuntary Product Recalls, Product Actions, and other FDA enforcement actions), loss, liability, injury, damage and/or expense, including reasonable attorneys’ fees and costs (hereinafter individually and collectively a “Claim”) for which the Party contends it is entitled to be defended, indemnified and held harmless under Sections 17.1 through 17.4 (hereinafter individually and collectively an “Indemnity Claim”) within 30 days after the Party making the Indemnity Claim becomes aware of the Claim; provided, however, that the failure to give such notice within the 30 day period shall not waive or in any way impair a Party’s right to be indemnified, defended or held harmless unless the delay in providing such notice has a material adverse effect on the indemnifying Party.  An Indemnity Claim shall be deemed accepted unless within 30 days after receiving the Indemnity Claim notice, the receiving Party notifies the other Party in writing that the receiving Party will not defend, indemnify and hold the sending Party harmless

 

17.6                        An indemnified Party shall reasonably cooperate with the indemnifying Party with respect to any investigation or defense of any Claim.

 

 

17.7                        Upon receiving notice of a Claim, ANI may, for purposes of funding reserves for Litigation Expenses and related damages, withhold Net Profits that would otherwise be distributed to RiconPharma pursuant to Section 5.2, place such amounts in escrow and use such reserves to pay Litigation Expenses from a Claim or to pay the deductible or SIR and related damages on any Policy.

 

17.8                        The indemnifying Party shall have the right to control the defense or settlement of an Indemnity Claim that it has accepted.  The indemnified Party may participate in (but not control) the defense of a Claim at its sole cost and expense.

 

17.9                        Where a Party refuses to accept an Indemnity Claim, the other Party’s defense of the Claim will not be deemed a waiver or admission of any kind against the refusing Party for indemnity, defense and to be held harmless under this Section 17.

 

17.10                 A Party may not settle a Claim without the consent of another Party [if such settlement would require the other Party to submit to an injunction].

 

18.                               INSURANCE.

 

18.1                        Not later than the Initial Marketing Date with respect to a Product, each Party shall obtain and maintain during the Term of this Agreement and for a period of three years after the Termination of this Agreement at its own expense insurance policies, including product liability insurance, providing coverage for any personal injury or property damage allegedly caused by the Products or the acts and omissions of the Parties relating to the Products (the “Policies”) with liability limitations of: (i) in the cases of ANI, not less than [ *** ] per occurrence and in the aggregate; and (ii) in RiconPharma’s case [ *** ] per occurrence and in the aggregate if there is one Amending Product Exhibit to this Agreement.  If there is more than one Amending Product Exhibit to this Agreement, or if the total dollar value of sales of Products by ANI exceeds [ *** ], the liability limitations for the RiconPharma Policies shall be a minimum of [ *** ] per occurrence and in the aggregate.  Each Party shall deliver a certificate of insurance on an Accord form or equivalent to the other Party evidencing that the Policies are in effect and providing that the Policies will not be cancelled or modified without first giving 30 days advance notice to the certificate holder.  Any Party may request to be named as an additional insured on the Policies obtained and maintained by the other Party, subject to approval by the insurance provider.  The Policies obtained and maintained by each Party shall provide contractual liability insurance providing coverage for the indemnity, defense and hold harmless obligations undertaken by that Party under this Agreement.

 

18.2                        Subject only to Section 18.3 below, the Policies obtained and maintained by RiconPharma shall be primary to any Policies obtained and maintained by ANI with respect to any Claim.  The Policies shall have a maximum deductible or self-insurance retention (“SIR”) of [ *** ] per policy.

 

 

18.3                        ANI’s Policies shall be primary with respect to RiconPharma’s Policies as to any Claim for which ANI owes indemnity and defense to RiconPharma under Section 17.4 of this Agreement.

 

19.                               AUDITS AND INSPECTIONS.

 

19.1                        Each Party shall keep complete and accurate accounts, records, books and-data with respect to its obligations hereunder including the books and records identified and described in Section 13 of this Agreement (the “Records”).  Each Party shall have the right at reasonable times upon prior written notice to another Party, to inspect copy and audit the Records relating to the other Party’s performance and obligations under this Agreement.  A Party shall permit authorized representatives of the other Party to inspect the Party’s facilities and quality systems in connection with the Product during standard business hours and for reasonable periods for the purpose of assuring that the Party is complying with the federal and state laws and regulations relating to the production of the Product.  Such inspection shall be at the inspecting Party’s sole expense and upon at least five (5) business days advance written notice to the other Party.

 

19.2                        In the event of an audit or inspection of one of the Party’s facilities by any Regulatory Authority, that Party shall supply the other Parties with notice of the audit or inspection and a copy of any report received from such Regulatory Authority and the inspected Party shall provide such Regulatory Authority with a prompt, accurate and complete response to any deficiencies or observations noted during the audit or inspection.  The Party inspected or audited agrees that it shall promptly address, and if necessary correct, any and all such deficiencies or observations, and obtain any required approval or reclassification from the Regulatory Authority.

 

19.3                        In the event of an audit or inspection of one of the facilities of a Third Party manufacturer or supplier of any Raw Materials or Components, the Party who hired or contracted with the Third Party (the “Retaining Party”) shall notify the other Party of the audit or inspection and provide to the other Parties a copy of any report the Retaining Party receives issued by the Regulatory Authority pertaining to the audit or inspection.

 

20.                               TERM AND TERMINATION.

 

20.1                        This Agreement shall become effective on the Effective Date and continue until terminated in accordance with this Agreement (the “Term”).

 

20.2                        The Parties may jointly agree in writing, at any time, to terminate any Product Exhibit to this Agreement.  In the event that any Amending Product Exhibit to this Agreement is terminated pursuant to this Section 20.2, the effect of such termination shall be as set forth in the agreement between the Parties documenting that termination.  In the event that all Amending Product Exhibit to this

 

 

Agreement have been terminated, a Party may terminate this Agreement by providing the other Parties with thirty (30) days’ prior written notice.

 

20.3                        This Agreement or any Amending Product Exhibit may be terminated effective immediately by written notice by a Party to the other Party at any time during the Term of this Agreement for material breach by the other Party of any provision of this Agreement, which breach remains uncured for thirty (30) days from the date written notice of such breach is given to the breaching Party; provided, however, that if such breach is not cured within the stated period and the breaching Party uses Commercially Reasonable Efforts to cure such breach, the stated period will be extended by an additional thirty (30) days.

 

20.4                        Prior to the issuance of an ANDA for a Product, a Party may terminate its interest and involvement in the Amending Product Exhibit for that Product upon thirty (30) days’ prior written notice to the other Party.  In that event, the terminating Party shall be required to pay or reimburse the non-terminating Party for its respective share of the Development Costs as set forth in the Amending Product Exhibit.  In addition, the terminating Party shall not pursue the development, manufacture, marketing, distribution or sale of such Product or a Bioequivalent Product manufactured by a Third Party for a period of five (5) years after the effective date of such termination.

 

20.5                        After the issuance of an ANDA for a Product, a Party that desires to terminate its interest or involvement in an Amending Product Exhibit to this Agreement with respect to such Product other than by reason of Section 20.3, shall give the other Parties not less than sixty (60) days’ prior written notice thereof, such termination to be effective at the conclusion of such sixty (60) day period.

 

20.6                        If a Party terminates its interest in an Amending Product Exhibit to this Agreement by reason of Sections 20.4 or 20.5, or the other Party terminates this Agreement or any Amending Product Exhibit pursuant to Section 20.3, the Party not terminating or in breach, as applicable (the “Continuing Party”), may continue to develop, market, manufacture, and sell the Product on the Amending Product Exhibit, as the case may be, and shall have the right to purchase the rights of the breaching or terminating Party as the case may be (the “Non-Continuing Party”) in and to the Product.  The Non-Continuing Party shall contemporaneously assign or license, as applicable, to the Continuing Parties, all of the Non-Continuing Party’s rights (including proprietary rights) to continue to develop, make, have made, use, import, market, offer for sale or sell the Products, including any Manufacturer and Development Technology.  The assigned or licensed rights, as applicable, shall include, without limitation, Regulatory Approvals (including the ANDA), the trade name for the Product and the manufacturing rights, the good will related to the Product, accounts receivable, and inventory of the Product.  The purchase price of such assigned or licensed rights shall be [ *** ] and the following additional provisions shall apply:

 

 

(a)                                 By ANI.  If ANI is the Non-Continuing Party then, subject to the terms and conditions of this Agreement, (i) it shall grant to RiconPharma non-exclusive license in and to Manufacturing and Development Technology it has to the extent necessary for RiconPharma to perform ANI’s obligations and exercise its rights under this Agreement, including, without limitation, any and all obligations and rights that need to be performed or exercised by or on behalf of ANI to develop, make, have made, use, import, market, offer for sale or sell the Product in accordance with this Agreement and (ii) at the request of RiconPharma, ANI shall manufacture the Product in compliance with the terms and conditions of this Agreement for a period not to exceed twelve (12) months following the notice of termination.  Following any termination in respect of which ANI is the Non-Continuing Party, ANI shall use Commercially Reasonable Efforts to assist RiconPharma in transferring the manufacturing of the Product to a Third Party.  For a period of twelve (12) months following the notice of termination, ANI shall not develop, apply for Regulatory Approval for, manufacture, import, market, sell or promote any product that is a direct substitute for the Product, including any Bioequivalent Product.  If the ANDA is in ANI’s name, it shall execute all documents and take all other actions necessary to transfer the ANDA in accordance with the instructions of ANI and RiconPharma,

 

(b)                                 By RiconPharma.  If RiconPharma is the Non-Continuing Party then, subject to the terms and conditions of this Agreement, it shall grant to ANI non-exclusive license in and to Manufacturing and Development Technology it has to the extent necessary for ANI to perform RiconPharma’s obligations and exercise its rights under this Agreement, including, without limitation, any and all obligations and rights that need to be performed or exercised by or on behalf of RiconPharma to develop, make, have made, use, import, market, offer for sale or sell the Product in accordance with this Agreement.  For a period of twelve (12) months following the notice of termination, RiconPharma shall not develop, apply for Regulatory Approval for, manufacture, import, market, sell or promote any product that is a direct substitute for the Product, including any Bioequivalent Product.  If the ANDA is in RiconPharma’s name, it shall execute all documents and take all other actions necessary to transfer the ANDA in accordance with the instructions of ANI.

 

21.                               CONFIDENTIALITY.

 

During the term of this Agreement, each Party will be exposed to confidential proprietary technical information belonging to the other Party that pertains to the operation of the other Party’s businesses or the operation of its business in general, including but not limited to the formulations, related technical information and data, packaging, research, operations, manufacturing processes, marketing, strategy, know-how and product information for a Product.  Each Party agrees not to (i) disclose, during the term of this Agreement or thereafter, to any other person any Confidential Information of the Party,

 

 

or (ii) use, after the term of this Agreement, any Confidential Information of the other Party for any purpose.  “Confidential Information” includes all information that derives independent economic value from not being generally known, or not being readily ascertainable by proper means, by other persons who can obtain economic value from the disclosure or use of such information, and any other information identified by a Party as being Confidential Information.  For purposes of this Agreement, “Confidential Information” does not include any information that (i) at the time of disclosure or thereafter is publicly available (other than as a result of a violation of this Paragraph), (ii) was or becomes available to the recipient on a non-confidential basis from a source other than the disclosing Party, provided that such source is not and was not bound by a confidentiality agreement with or other obligation of secrecy to the disclosing Party; or (iii) is independently acquired or developed by the recipient without violating any of its obligations under this Paragraph. The obligations of the Parties set forth in this Paragraph shall survive the termination or expiration of this Agreement.

 

22.                               FORCE MAJEURE.

 

No Party shall be liable or be in breach of any provision of this Agreement for any failure or delay on its part to perform any obligation where such failure or delay has been occasioned by any act of God, war, riot, fire, explosion, flood, sabotage, unavailability of fuel, labor, containers or transportation facilities, accidents of navigation or breakdown or damage of vessels or other conveyances for air land or sea, other impediments or hindrances to transportation, government intervention (other than that of a duly-authorized Regulatory Authority), strikes or other labor disturbances or any other cause beyond the control of the Parties.

 

23.                               NOTICES.

 

All notices and other communications required or permitted to be given or made pursuant to this Agreement shall be in writing signed by the sender and sent to the address or number below by facsimile transmission or Federal Express or another recognized overnight mail service that utilizes a written form of receipt for next day or next business day delivery.  The notice shall be deemed duly given (a) if faxed by 4:00 p.m., New York time, on the date sent by fax provided there is a confirmation by the transmitting machine showing the proper number of pages were transmitted without error or (b) if sent by overnight mail, on the business day after being sent by Federal Express or another recognized overnight mail service which utilizes a written form of receipt for next day or next business day delivery.  A Party may change its address or fax number for receiving notice by the proper giving of notice hereunder:

 

 

To:                            ANI

 

ANI Pharmaceuticals, Inc.

210 Main Street West

Baudette, MN 56623

USA

Attention: Vice President & CFO

Fax:   +1(218) 634-3540

 

To:                            RiconPharma

 

RiconPharma LLC

100 Ford Road, Suite #9

Denville, NJ  07834

USA

Attention: President & CEO

Fax:  +1(973) 627-4735

 

24.                               EXECUTION OF ALL NECESSARY ADDITIONAL DOCUMENTS.

 

Each Party agrees that it will forthwith upon the request of the other Party execute and deliver all documents and will take all such other actions as the other Party may reasonably request from time to time in order to effectuate the provision and purposes of this Agreement.

 

25.                               WAIVER.

 

Any failure of a Party to enforce at any time any of the provisions of this Agreement shall not be deemed or construed to be a waiver of such provisions or a waiver of any right of such Party thereafter to enforce each and every such provision on any succeeding occasion or breach thereof.

 

26.                               ASSIGNMENT AND AMENDMENT.

 

26.1                        Other than an assignment pursuant to Section 2.3, neither this Agreement nor any rights hereunder shall be assigned by a Party without the prior written consent of the other Party, and then only upon approval of the other Party and acceptance of such assignment in written form approved by such Party, which approval shall not be unreasonably withheld, conditioned or delayed.  In the event of an assignment by a Party to any Affiliate thereof as permitted hereunder, the assigning Party shall not be released from its obligations hereunder, and shall guarantee the full performance by such Affiliate of such obligations.

 

26.2                        No amendment hereof shall be binding unless made in writing and signed by each of the Parties hereto.

 

 

27.                               ENTIRE AGREEMENT.

 

This Agreement, including the Amending Product Exhibits to this Agreement, incorporates the entire understanding of the Parties and revokes and supersedes any and all agreements, contracts, understandings or arrangements that might have existed heretofore among the Parties regarding the subject matter hereof, and all prior agreements and understandings between the Parties and relating to the subject matter hereof are superseded by this Agreement.  No Party shall be liable or bound to another Party in any manner by any representations, warranties or covenants relating to such subject matter except as specifically set forth herein.  This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument.  This Agreement may also be executed via facsimile, which facsimile shall be deemed an original.

 

28.                               GOVERNING LAW; ARBITRATION; LANGUAGE.

 

28.1                        This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, without giving effect to conflict of law principles thereof, and the Parties consent to and agree to submit to the jurisdiction of the courts of, and accept service of process from, the State of New York, state and federal, with respect to any Claim or other claim, action, lawsuit, or proceeding relating to or out of this Agreement.  The Parties expressly agree that, to the maximum extent permitted by law, the requirements of any multilateral or bilateral treaties, now or hereafter existing, between two or more countries that place any obligations or duties on a Party or the Parties that are inconsistent with or in addition to any of its obligations and duties under this Agreement, shall not apply to this Agreement or to the Parties’ performance hereunder without the consent of all Parties.  This Agreement shall exclude, and not be governed by, either the provisions of the International Sale of Goods Act, or the United Nations Convention on the International Sale of Goods, regardless of that Convention’s legal or statutory adoption by any jurisdiction.

 

28.2                        In the event of any Indemnity Claim or other dispute, claim, question or disagreement out of or relating to this Agreement, or the breach hereof, the Parties shall use Commercially Reasonable Efforts to settle such Indemnity Claim or other dispute, claim, question or disagreement.  To this end, the Parties shall consult and negotiate with each other in good faith and, recognizing mutual interests, attempt to reach a just and equitable solution satisfactory to each of the Parties.  If the Parties do not reach such resolution within a period of thirty (30) days, any Indemnity Claim or other dispute, claim, question or disagreement out of or relating to this Agreement, or the breach hereof, where the total amount in controversy between the Parties is less than [ *** ], shall be determined and settled by binding arbitration in New York County, New York before a three member panel of the American Arbitration Association or JAMS in accordance with the provisions of the tribunal’s then applicable Commercial Arbitration Rules.  Notice of the demand for arbitration shall be made in writing to the other Party and to the arbitral tribunal.  Nothing contained in this Section 28.2 shall prevent a Party

 

 

from seeking interim or final equitable relief from the arbitral tribunal of a state or federal court of competent jurisdiction in the State of New York.  In no event shall the demand for arbitration be made after the date when institution of legal or equitable proceedings based on the claim or dispute would be barred by the applicable statute of limitations.  Any award rendered by the arbitration panel shall be final and conclusive upon the Parties and a judgment thereon may be entered in any court having competent jurisdiction.

 

28.3                        Each Party represents that it has been represented by legal counsel in connection with this Agreement.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

 

29.                               SEVERABILITY.

 

If any term or provision of this Agreement shall be held invalid or unenforceable, the remaining terms hereof shall not be affected, but shall be valid and enforced to the fullest extent permitted by law.

 

30.                               HEADINGS.

 

The headings used in this Agreement are intended for guidance only and shall not be considered part of this written understanding between the Parties hereto and shall have no effect on the meaning of the provisions hereof.

 

31.                               SURVIVAL.

 

All representations, warranties, and covenants of the Parties and the terms and conditions of Sections 3.2, 5, 10, 11, 14, 17, 18, 21, and 28 shall survive the termination of any Amending Product Exhibit and/or this Agreement, notwithstanding any language in the Agreement to the contrary.

 

[remainder of page intentionally left blank; signature page follows]

 

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]

 

IN WITNESS WHEREOF, this Agreement has been executed by the Parties on the date first above written.

 

	
 
    	
ANIP Acquisition Company
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Charlotte C. Arnold
    
	
 
    	
 
    	
Name:
    	
Charlotte   C. Arnold
    
	
 
    	
 
    	
Title:
    	
Vice   President & CFO
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
RiconPharma LLC
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:   
    	
/s/   Raj Devalapalli
    
	
 
    	
 
    	
Name:
    	
Raj   Devalapalli
    
	
 
    	
 
    	
Title:
    	
President &   CEO
    

 

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked: [***]

 

AMENDING PRODUCT EXHIBIT A-1

 

[ *** ]

 

 

AMENDING PRODUCT EXHIBIT A-2

 

[ *** ]

 

 

AMENDING PRODUCT EXHIBIT A-3

 

[ *** ]

 

 

AMENDING PRODUCT EXHIBIT A-4

 

[ *** ]

 

 

AMENDING PRODUCT EXHIBIT A-5

 

[ *** ]Exhibit 10.58

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

ADDENDUM NO. 1 to
 AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT

 

THIS ADDENDUM NO. 1 (this “Addendum”) is dated as of               , 2010 and is between ANIP ACQUISITION COMPANY, d/b/a ANI PHARMACEUTICALS, INC., a Delaware corporation (“ANI”) and ALAVEN PHARMACEUTICALS, LLC, a Delaware limited liability company, (“ALAVEN”).

 

The parties wish to set forth additional terms and conditions under which ANI will purchase and store, on behalf of ALAVEN, the active pharmaceutical ingredient [***].

 

TERMS AND CONDITIONS FOR [***] PURCHASE AND STORAGE

 

I.                                        ANI will place purchase orders, as requested by ALAVEN, for [***] from ALAVEN’S designated [***] Supplier;

II.                                   Immediately upon receipt of invoice from Supplier, ANI will forward such invoice to ALAVEN for reimbursement to ANI;

III.                              ALAVEN will reimburse ANI upon receipt of Supplier’s invoice, whereupon ANI will immediately pay Supplier’s invoice;

IV.                               Upon receipt of the [***], ANI will store the material under cGMP conditions.  Risk of damage or loss of the material shall remain with ALAVEN, unless ANI was negligent in the storage or handling of the [***];

V.                                    ALAVEN will pay ANI $500 per month for up to two pallets of [***], payable quarterly in advance.

 

IN WITNESS WHEREOF, the parties have caused this Addendum to be duly executed on the date first written above.

 

	
ANI   PHARMACEUTICALS, INC.
    	
 
    	
ALAVEN PHARMACEUTICALS. INC.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ James G. Marken
    	
 
    	
By:
    	
/s/ Lawrence Levey
    
	
Name:
    	
James G. Marken
    	
 
    	
Name:
    	
Lawrence Levey
    
	
Title:
    	
VP Operations
    	
 
    	
Title:
    	
Director, Supply Chain
    
	
Date:
    	
12/1/2010
    	
 
    	
Date:
    	
12/1/2010
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
MEDA PHARMACEUTICALS INC.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
By:
    	
/s/ Dennis Fuge
    
	
 
    	
 
    	
 
    	
Name:
    	
Dennis Fuge
    
	
 
    	
 
    	
 
    	
Title:
    	
VP of Supply Chain
    
	
 
    	
 
    	
 
    	
Date:
    	
12/1/2010
    

 

1

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

AMENDED AND RESTATED
 MANUFACTURING AND SUPPLY AGREEMENT

 

THIS AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) is dated as of June 10, 2008, and is between ANIP ACQUISITION COMPANY, d/b/a ANI PHARMACEUTICALS, INC., a Delaware corporation (“ANI”), and ALAVEN PHARMACEUTICAL, LLC, a Delaware limited liability company, (“ALAVEN”).

 

The parties wish to set forth the terms and conditions under which ANI will manufacture for and supply to ALAVEN the Products described herein.  Accordingly, in consideration of the mutual promises and undertakings contained herein and intending to be legally bound hereby, the parties hereto agree as follows:

 

ARTICLE I
 DEFINITIONS

 

When used in this Agreement, the following terms shall have the meanings set forth below:

 

“Act” shall mean the Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder from time to time.

 

“Additional Purchase Price” shall have the meaning given to that term in Section 2.4(b) hereof.

 

“Affiliate” shall mean any person or legal entity controlling, controlled by or under common control with the person with respect to whom such status is at issue and shall include, without limitation, any corporation 50% or more of the voting power of which (or other comparable ownership interest for an entity other than a corporation) is owned, directly or indirectly, by a party hereto or any corporation, person or entity which owns 50% or more of such voting power of a party hereto.

 

“Agreement” shall have the meaning given to that term in the introductory paragraph hereof.

 

“API” means, as applicable to specific Products, [***].

 

“cGMP” means the current Good Manufacturing Practice regulations applicable to the manufacture of the Products hereunder.

 

“Claims” shall have the meaning given to that term in Section 5.1 hereof.

 

“Confidential Information” shall have the meaning given to that term in Section 7.1 hereof.

 

“Contract Quarter” shall mean each period of three (3) successive calendar months during each Contract Year, ending on March 31, June 30, September 30, and December 31.

 

“Contract Year” shall mean the period from the Effective Date through and including the date each year that is the day before the anniversary of the Effective Date, unless terminated before such later date as provided herein.

 

1

 

“Closing Date” shall mean the date ANI closes on the Asset Purchase Agreement with Solvay Pharmaceuticals, Inc. and thereby acquires the equipment and facilities necessary to fulfill its obligations to ALAVEN under this Agreement.

 

“Effective Date” shall mean the Closing Date.

 

“Equipment” shall mean the equipment used by ANI in the production of the Products which is to be sold to ALAVEN as provided in Section 4.4(b).

 

“FDA” shall mean the United States Food and Drug Administration and any successor agency.

 

“Force Majeure Event” shall have the meaning given to that term in Section 9.1 hereof.

 

“Form” shall have the meaning given to that term in Section 2.3 hereof.

 

“Generic Product” shall have the meaning given that term in the License Agreement.

 

“Indemnitee” shall have the meaning given to that term in Section 5.3 hereof.

 

“Indemnitor” shall have the meaning given to that term in Section 5.3 hereof.

 

“Labeling” shall mean all unit Products labels, package inserts, carton imprints, tablet debossing/embossing and/or imprinting and all other markings on packaging for, or other similar materials related to, the Products that are defined as labels or labeling under any applicable law or regulation.

 

“Labeling Specifications” shall mean the labeling and packaging specifications for the Products attached hereto as Exhibit B and made a part hereof, as such specifications may be amended from time to time by mutual agreement in writing of the Parties.

 

“Law” means any applicable statute, law, ordinance, rule, regulation, order, judgment, ruling or decree enacted, adopted, issued or promulgated by any Regulatory Authority.

 

“License Agreement” shall mean the License Agreement dated as of the date of this Agreement by and between ANI and ALAVEN.

 

“Manufacturing Authorization” means any authorization necessary to manufacture the Products as granted by the applicable Regulatory Authority.

 

“Manufacturing Standards” shall mean all U.S.  Laws applicable to the manufacture of the Products.

 

“NDC” shall mean the national drug code assigned to each Product by the FDA.

 

“Nonconformance” shall have the meaning given to that term in Section 2.7(c) hereof.

 

“Original Date” shall mean April 30, 2007, the date the original Manufacturing and Supply Agreement was signed.

 

“PPI” shall have the meaning given to that term in Section 2.4(b) hereof.

 

“Products” shall mean the pharmaceutical dosage form consisting of:

 

2

 

[***] as an active ingredient in the presentations [***] and incorporated herein by reference, including, without limitation, [***], whether to be ultimately sold by ALAVEN under the [***] or in generic form.

 

[***] in the presentations [***] incorporated herein by reference, including, without limitation, [***], whether to be ultimately sold by ALAVEN under the [***] or in generic form.

 

[***] as an active ingredient in the presentations [***] incorporated herein by reference, including, without limitation, [***], whether to be ultimately sold by ALAVEN under the [***] or in generic form.

 

[***] in the presentations [***] and incorporated herein.

 

“Product Specifications” shall mean the specifications for the Products attached hereto as Exhibit C and incorporated by reference herein, the Products specifications and methods set forth as of the date hereof in the manufacturing and control sections of the new drug application heretofore submitted to and approved by the FDA for the Products (including any Labeling requirements specified therein) and any amendments to such specifications that may be mutually agreed upon by the parties in writing.

 

“Reglan Products” shall mean the Products to be manufactured hereunder in which Metoclopramide is the active ingredient.

 

“Regulatory Authority” shall mean any U.S.  governmental regulatory authority involved in granting approvals for the manufacture, marketing, sale, reimbursement and/or pricing of Products in the U.S., including, without limitation, the FDA and any judicial or administrative decisions relating thereto.

 

“Regulatory Change” shall have the meaning given to that term in Section 9.2 hereof.

 

“Regulatory Standards” shall mean all laws, rules, regulations and Regulatory Authority advisory opinions or orders applicable to the manufacturing, marketing, sale, reimbursement and/or pricing of any Products.

 

“ANI’s Shipping Point” shall mean ANI’s facility in Baudette, Minnesota,

 

“Specifications” shall mean the Products Specifications and the Labeling Specifications.

 

“Standard Cost” shall have the meaning given to that term in Section 2.4(b) hereof.

 

“Tooling” means the tooling currently or hereafter owned by ALAVEN which ALAVEN will permit ANI to use during the Term of this Agreement for the sole purpose of facilitating the manufacture of the Products by ANI.  ANI will not have, and no provisions of the Agreement will be deemed to give to ANI, any interest in the Tooling.

 

ARTICLE II
 SUPPLY

 

2.1                               Generally.  Subject to the terms and conditions of this Agreement, ANI shall supply to ALAVEN and ALAVEN shall purchase from ANI the Products in such quantities as ALAVEN may order hereunder from time to time for its worldwide requirements.  ANI shall supply the Products in

 

3

 

finished, packaged form and tested in accordance with the Specifications and Manufacturing Standards.  ANI will not implement any change in materials, components, processes or test methods without consulting with and receiving the prior written approval of ALAVEN.  ANI will utilize its change control processes in this regard.  In addition, a Quality Agreement will be developed for quality governance substantially in the form attached hereto as Exhibit D.  Notwithstanding any other provision of this Agreement, ANI agrees not to manufacture, package or sell to any other person or entity any enema product containing [***], any perianal wash, cream or lotion product, or any product containing [***] (i) during the Term (as hereinafter defined), or (ii) for a period of two (2) years following termination of this Agreement by ANT or termination by ALAVEN pursuant to Section 4.3.

 

2.2                               Forecasts.

 

(a)                                 Initial Forecast.  Within fifteen (15) business days of the Original Date, ALAVEN submitted to ANI a written forecast of its requirements for the Products (other than the [***]) for the first Contract Year, the first Contract Quarter of which shall constitute a firm commitment of ALAVEN.

 

(b)                                 Subsequent Forecasts.  ALAVEN shall submit to ANI by the first day of each successive Contract Quarter a 12-month rolling forecast, by Contract Quarter, of its requirements for the Products, the first quarter of which shall constitute a firm commitment of ALAVEN.

 

2.3                               Purchase Orders.  Within thirty (30) days of the Original Date of this Agreement, ALAVEN placed its initial purchase order for the first quarter which is the initial firm commitment period described in Section 2.2(a).  ALAVEN shall place orders for Products only in whole number multiples of specified-size lots.  ALAVEN shall place each subsequent order for Products by delivering to ANI a written purchase order specifying the quantity and delivery date (which delivery date shall not be less than ninety (90) days after the date such purchase order is delivered to ANI unless otherwise agreed).  Unless the parties otherwise agree, quantities specified in purchase orders for each Product for the second and subsequent Contract Quarters may not be less than 80% nor more than 120% of those set forth for such quarter in the most recent forecast submitted to ANI hereunder; provided, however, that ANI will use commercially reasonable efforts to fill any orders for quantities in excess of such maximum amount.  ANI shall acknowledge and accept each purchase order received from ALAVEN which complies with the forecast and order procedures set forth herein, within four (4) business days after receipt.  All contrary, inconsistent or additional provisions, terms or conditions of any purchase order, sales or order acknowledgement, invoice or other standard business form (a “Form”) of either party shall be superseded by this Agreement and shall be disregarded and have no force or effect.  If a Form purports to be conditioned in any manner on agreement to and/or acceptance of any provisions, terms or conditions other than those set forth herein, then such condition is hereby deemed waived.

 

2.4                               Pricing and Payment.

 

(a)                                 General Price.  The purchase price of Products supplied to ALAVEN hereunder shall be as shown in Exhibit A plus any applicable sales or use taxes, duties and other similar taxes, unless ALAVEN provides ANI with a valid resale certificate or other proof of exemption; provided, however, that ALAVEN has received a credit of [***] against the costs that it would otherwise be required to reimburse to ANI under Section 2.10 hereof, reflecting the difference between the price paid for the [***] products ordered by ALAVEN prior to June 30, 2007, and the price that ALAVEN would have paid for the [***] products based on the price in effect as of the day prior to the Effective Date; provided further, that notwithstanding the foregoing, Product orders which are in process by Solvay prior to the Effective Date shall be invoiced at the purchase price in effect when the purchase order was placed with Solvay.

 

4

 

(b)                                 Price Changes.  For purposes hereof, “Standard Cost” with respect to the initial two Contract Years shall mean [***].  The Standard Cost for each Product shall be adjusted, effective as of the annual date of each Contract Year, beginning with the third Contract Year during the Term hereof, to equal [***].  No later than sixty (60) days prior to the annual date of the Contract Year in the Initial/ Renewal Term, beginning with the Third Contract Year, ANI shall notify ALAVEN in writing of the new Standard Costs for the next Contract Year identifying the basis for any increases with reasonable specificity.  Any upward adjustment shall not exceed the change in the U.S.  Pharmaceutical Producer Price Index (“PPI”) over the preceding 12-month period.

 

(c)                                  Other Increases and/or Payments: ANI may charge to ALAVEN and ALAVEN shall promptly pay (i) subject to agreement with ALAVEN as contemplated hereby, specific capital purchases that are directly and uniquely required for the ongoing Production of Products and/or to maintain the manufacture of Products in cGMP compliance (title to any such items vesting in ALAVEN upon payment), (ii) any other extraordinary expenses which are beyond the control of ANI but which are directly and uniquely required to maintain Production and supply of Products (for example environmental or other regulatory requirements that may be adopted after the date of this Agreement).  In addition, specific material price increases for the active pharmaceutical ingredient charged by unaffiliated third parties that directly affects the Products and that exceeds the annual PPI may be included in Standard Cost as incurred on a first-in, first-out basis (subject to notification by ANI to ALAVEN of any such increase identifying the amount thereof with reasonable specificity).  ALAVEN reserves the right to require ANI to provide explanations and records of any such Products specific issues and their necessity.  ANI will consult with ALAVEN for consensus and written agreement prior to initiating capital purchases specific for the Products.  ALAVEN acknowledges that any refusal of consent to such capital purchases may detrimentally affect the ability of ANI to perform its obligations hereunder and any resulting failure to perform shall be deemed a consensual cessation of supply hereunder, pending agreement being reached on which party will purchase such items and the allocation of the cost between the parties.  Except for the adjustments to Standard Cost expressly permitted by this subsection (c), costs paid by ALAVEN to ANI pursuant to this subsection shall not be included in Standard Cost.

 

(d)                                 Invoicing and Payment.  ANI shall invoice ALAVEN for each shipment of the Products simultaneously with ANI’s actual shipment of Products and delivery to ALAVEN of a certificate of analysis relating to such shipment.  Payment shall be due within [***] from invoice date.  Past due balances shall be subject to a service charge of 12% per annum, but in no event shall such charge exceed the maximum rate permitted by law.  All payments shall be made in U.S.  dollars.

 

(e)                                  Books and Records.  ANI shall maintain accurate books and records of Standard Cost and other costs for which ALAVEN is responsible pursuant to Section 2.4 which shall, from the date hereof until twelve (12) months following the expiration date of the last batch of Product manufactured hereunder, be made available for inspection and audit by ALAVEN at least once per year solely for the purpose of verifying price increases pursuant to this Section 2.4 and other costs for which ALAVEN is responsible.  ALAVEN shall be responsible for the costs of any such inspection and audit, provided that if it is determined that ALAVEN has paid costs which exceed the costs as to which ALAVEN is responsible pursuant to Section 2.4 by more than 5%, ANI shall be responsible for the reasonable costs of such audit, as well as for refunding the amount of the ALAVEN overpayment.

 

(f)                                   FDA Establishment Fee.  ALAVEN will be responsible for the entire FDA Establishment Fee, but only so long as ALAVEN is the sole NDA holder (without generic equivalent) for the Facility; it being acknowledged and agreed by ANI that if there are any other present or future NDA holders whose products do not have generic equivalents who are supplied from the Facility such NDA holders will share such costs on a pro rated basis.

 

5

 

2.5                               Delivery.

 

(a)                                 Generally.  All Products sold to ALAVEN hereunder shall be delivered to ALAVEN FOB ANI’s Shipping Point.  All risk of loss shall pass to ALAVEN when ANI so delivers Products to a carrier for ALAVEN.  ALAVEN shall designate a carrier and mode of shipment on each purchase order submitted to ANI; provided, however, that should ALAVEN fail to designate a carrier on its purchase order, ANI shall use the common carrier designated by ALAVEN as its default carrier, or if ALAVEN shall fail to designate a default carrier, ANI may select a common carrier for the account and risk of ALAVEN.

 

(b)                                 Deviation from Agreed Delivery Time.  ANI shall use commercially reasonable efforts to fill each purchase order submitted hereunder by the specified shipment date.  Originally agreed times for delivery to ALAVEN’s carrier are not to be deemed of the essence of an accepted order, and reasonable deviations from originally agreed times will be accepted by ALAVEN.  Deviations of more than forty-five (45) days shall be deemed unreasonable, unless ALAVEN has on hand an inventory of Products sufficient to meet ALAVEN’s requirements (based on its forecasts delivered to ANI under Section 2.2) for 90 days, in which case deviations of more than 60 days will be deemed unreasonable.

 

(c)                                  Delay in Delivery.  ALAVEN recognizes the inherent difficulty in producing the Products and also recognizes that delays in shipment, while non-routine, may occur from time to time.  ANI shall notify ALAVEN promptly of any circumstance that may cause a delay in making Products available for shipment FOB ANI’s Shipping Point, stating the estimated period of delay and the reasons therefore.  ANI shall use commercially reasonable efforts to avoid or minimize the delay, including, when necessary or at ALAVEN’s request, the expenditure of premium time and shipping via air or other expedited routing.  Any additional cost caused by such requirements shall be borne by the party causing the delay to the extent of any culpability.  If no culpability can be assigned to either party, such additional costs for premium time and air shipment requested by ALAVEN shall be borne solely by ALAVEN.  Nothing herein may be construed to prejudice any of the express rights or remedies provided to either party in this Agreement.  In addition to any such rights ALAVEN may have hereunder, ALAVEN shall have the right to cancel any order which is not made available for shipment FOB ANI’s Shipping Point for more than sixty (60) days after its agreed shipment date for causes other than Force Majeure Events or Regulatory Changes so long as such delay has arisen through no fault or negligence of ALAVEN.  Notwithstanding the foregoing, ANI shall not be liable in any way (including, without limitation, for the additional costs caused by the requirements set forth above in this section) for any delay excused under Article IX hereof.

 

(d)                                 Priority of Supply.  If for any reason (including without limitation, a back order situation, a Force Majeure Event or a Regulatory Change) ANI is unable to supply ALAVEN’s demand for Products and the demands of ANI’s other customers (including ANI and ANFs Affiliates), ANI shall give ALAVEN’s demand at least equal priority to those of ANFs other customers (including ANI and ANFs Affiliates).

 

2.6                               Labeling and Packaging.

 

(a)                                 Generally.  ALAVEN shall provide to ANI and shall bear the sole responsibility for ensuring the accuracy of the information contained in all Labeling Specifications and for compliance thereof with all Regulatory Standards.  ANI shall be responsible for procuring all Labeling, which shall be created in accordance with the Labeling Specifications.  With respect to all Products to be supplied in finished, packaged form, ANI shall procure sufficient Labeling to cover quantities of the Products as to which ALAVEN’s forecasts under Section 2.2 hereof constitute a firm commitment.  Acquisition of

 

6

 

additional inventory of Labeling components beyond the three (3) month commitment shall be made only with advance consultation of ALAVEN.

 

(b)                                 Changes.  Should ALAVEN desire or be required to change any component of Labeling or to introduce a new packaging component to which Labeling will be affixed, ALAVEN shall so inform ANI and shall be responsible for updating the artwork or text, as applicable, and providing it to ANI in camera-ready or electronic form and in compliance with the Labeling Specifications.  ANI shall make all necessary arrangements for such Labeling to be printed and shall provide to ALAVEN printer’s proofs of all Labeling for ALAVEN’s review.  Within fifteen (15) business days of its receipt of such proofs, ALAVEN shall either provide to ANI any necessary corrections thereto or notify ANI of its approval of such proofs.  Upon ALAVEN’s acceptance thereof, ANI shall return all artwork provided by ALAVEN.  ANI shall be entitled to directly charge ALAVEN, amounts to take account of only those costs incurred in making changes to Labeling and/or packaging as provided for in this Section 2.6(b).  Allowable transition cost charges include, without limitation, the costs of acquiring new Labeling in a timely manner to meet ALAVEN’s pending purchase orders and forecast demand and the acquisition and disposal costs associated with obsolete inventory of Labeling, films, plates and packaging.  ANI will charge ALAVEN direct, out-of-pocket expenses in a one-time charge after completion of the Labeling transition.

 

2.7                               Stability Testing; Inspection of Products.

 

(a)                                 Stability Testing.  ANI shall provide stability testing for Products manufactured hereunder, and shall provide all stability results to ALAVEN in a timely fashion.  ANI and ALAVEN shall agree to a work outline to accomplish an acceptable stability program, including, but not limited to, the stability testing and release costs associated with the [***] as set forth on Exhibit E hereto, which is incorporated herein.  ANI shall retain a suitable quantity of retained samples until twelve (12) months after the stated expiration date for the tested Product.  ANI shall promptly notify ALAVEN in advance of any costs associated with the agreed upon stability testing program for the Products beyond those which ANI customarily and routinely incurs in connection with stability testing and such additional costs, once approved by ALAVEN (with such approval not unreasonably withheld), shall be charged to and shall be the sole responsibility of ALAVEN (through an adjustment to the Standard Cost).  ANI will notify ALAVEN of stability failures within 24 hours of ANFs becoming aware of any such failure.

 

(b)                                 Certificate of Analysis.  ANI will provide ALAVEN with a certificate of analysis for all batches of Products shipped to ALAVEN which shall include, without limitation, the expiry date.  Such certificate of analysis shall be delivered to ALAVEN at the time of shipment of the Products.  Delivery of any Products by ANI to ALAVEN shall constitute a certification by ANI that at the time of delivery the Products conforms to the certificate of analysis provided therewith and the Product Specifications and was manufactured in accordance with the Manufacturing Standards.  ALAVEN shall store all Products in conditions as specified in the Product Specifications.  All Products delivered to ALAVEN shall have a remaining expiry period of no more than three months less than the total initial labeled expiry period.  To avoid confusion, and as an example: for Products that has an initial labeled expiry period of 24 months, the Products delivered must have at least 21 months remaining expiry period upon receipt by ALAVEN.

 

(c)                                  Nonconformance.  Within thirty (30) days after its receipt of each shipment of Products at the destination specified in the shipping instructions, ALAVEN shall inspect such shipment for material nonconformance with the applicable purchase order, the applicable Specifications or the representations and warranties of ANI set forth herein (“Nonconformance”)- If, upon such inspection, ALAVEN discovers any Nonconformance, ALAVEN [***] reject the nonconforming portion of such shipment by giving prompt written notice to ANI.  Such notice shall include a copy of ALAVEN’s test

 

7

 

results and specify the precise Nonconformance upon which such rejection is based.  Absent such notification, ALAVEN shall be deemed to have accepted the shipment, except as to latent defects that could not have been detected in such 30-day period (“Latent Defects”).  In no event shall ANI be liable for any Nonconformance arising out of the shipment, storage, use or handling of the Products following its delivery FOB AM’s Shipping Point.

 

(d)                                 Procedure.  Upon notifying ANI of any Nonconformance, or upon notifying ANI of any Latent Defects, ALAVEN shall afford ANI a reasonable opportunity to inspect the shipment in question and make any appropriate adjustment or replacement.  The parties shall submit any dispute regarding the proper rejection of a shipment to a mutually selected independent laboratory, the determination of which shall be binding on the parties and the costs of which shall be borne by the party against whom such determination is rendered.  If such laboratory confirms a Nonconformance or Latent Defect in the shipment in question (or any part of it) at the time of delivery to the carrier, or if the parties agree that there is a shortage or a Nonconformance or Latent Defect, then ANI shall use commercially reasonable efforts to make up the shortage or replace any nonconforming Products, as the case may be, with such new Products to be shipped at ANI’s expense to the same destination as the original shipment.  If ANI is unable to make up the shortage or replace any nonconforming Products, it shall promptly refund any money paid by ALAVEN with respect to such undelivered or nonconforming Products and reimburse ALAVEN for the costs of shipping such Products.  ANI may, at its sole option, either direct ALAVEN to return nonconforming Products to ANI or have it destroyed by ALAVEN, and certify such destruction to ANI, all at ANI’s expense.  ANI’s supply of substitute Products which conform to the applicable Specifications or, as the case may be, payment of the refund and reimbursement provided for herein, shall satisfy and discharge all claims or potential claims which ALAVEN may have against ANI with respect to undelivered or nonconforming Products in that shipment, provided replacement Products is available to ALAVEN within thirty (30) days of the identified shortage.

 

2.8                               Inspection of Facility.  ALAVEN or its designees may, at its sole expense, inspect the facilities being used by ANI to manufacture, package, store or ship the Products to assure compliance with Manufacturing Standards.  Each such inspection shall be conducted upon reasonable advance notice, at mutually agreed times during regular business hours and in a manner which minimizes disruption of ANI’s business operations.  ALAVEN may conduct such inspections no more than twice each Contract Year unless it has a good faith reason to believe such facility is not materially in compliance with Manufacturing Standards.

 

2.9                               Recalls.  If any Regulatory Authority with applicable jurisdiction shall order, or it shall otherwise become necessary to perform, any corrective action or market action with respect to any Products manufactured by ANI (including, without limitation, any recall, field correction, market withdrawal, stock recovery, customer notice or restriction), ALAVEN shall have the exclusive responsibility to appropriately manage such action; provided, however, that for the first seven (7) days following any such action, ALAVEN may delegate such responsibility to ANI and ANI agrees to discharge such responsibility with the same degree of care and diligence as ANI would with respect to its own products.  If such corrective action or market action is necessitated by the breach by one of the parties of any of its warranties, representations, obligations, covenants or agreements contained herein, or in any Manufacturing Authorization, then such party shall be liable, and shall reimburse the other party, for all reasonable costs incurred by the non-breaching party in connection with such action (including, without limitation, reasonable attorney’s fees and expenses).  If each of the parties is partly responsible for such corrective action or market action, then each party shall be responsible for its proportionate share of such costs.  If neither party is responsible for such corrective action or market action, then ALAVEN shall be responsible for such costs.  ALAVEN shall also be exclusively responsible for handling all customer complaints, inquiries and the like, and ANI shall appropriately cooperate with ALAVEN,

 

8

 

including the completion of an investigation and the preparation and submission of a complaint report to ALAVEN or its designees.

 

2.10                        Process Improvements and Development Activities.  All future development and/or process improvement activities will require the discussion, evaluation and approval of a joint team, comprised of named ad-hoc members as appropriate, based on functional roles, from both ALAVEN and ANI, prior to implementation.  All costs of materials for these additional mutually agreed improvement and development activities will be the responsibility of ALAVEN.  The costs of ANI’s personnel that execute the experiments, physical development activities and other related activities resulting from this team will be the responsibility of ALAVEN and will be invoiced at ANI’s usual and customary rates; provided, however, that the specific current development activities associated with any reformulation of the [***] which are to be paid by ALAVEN under this Section 2.10, will be paid based on ANI’s cost, including laboratory and manufacturing personnel costs, materials and supplies.  Issues that cannot be resolved through this joint team will be escalated to the CEO’s of both organizations for final resolution.

 

2.11                        Transfer of [***].  ANI agrees, [***], to have the manufacture of the [***] transferred to ANI in accordance with the transfer responsibilities set forth on Exhibit F hereto, as incorporated herein.  ALAVEN agrees to complete the required regulatory filing for the transfer of the manufacture of the [***] to ANI, it being agreed, however, that ANI will promptly provide ALAVEN with CMC and such information as shall be required for ALAVEN to complete the regulatory filing.  Based upon the knowledge and experience of ANI and ALAVEN, the Parties anticipate that: (i) the transfer of the manufacture of the [***] will be completed by December 31, 2008, and (ii) the regulatory filing associated with such transfer will be completed within thirty (30) days of the receipt of the final three (3) month stability report (or other documentation deemed essential by ALAVEN to the regulatory filing) for the registration batches.

 

2.12                        On-going Stability.  Cost associated with on-going stability presently being conducted by the current manufacturer of the Products will be paid by ALAVEN.  In the event of ALAVEN product discontinuation, stability testing and associated cost will continue as ALAVEN’s responsibility through the conclusion of the required stability testing with respect to the Branded Product, unless a single stability test is being conducted for both the Branded Product and the Generic Product, in which case the costs will continue to be paid by ANIP as provided in Exhibit E.

 

ARTICLE III
 REPRESENTATIONS AND WARRANTIES

 

3.1                               Representations and Warranties of ANI.  ANI represents and warrants to ALAVEN as follows:

 

(a)                                 Conformance of Products.  Subject to ALAVEN’s obligations with respect to supplies of the Labeling Specifications under Section 2.6 hereof, each certification by ANI pursuant to Section 2.7(b) shall be deemed a representation and warranty hereunder, any breach of which representation and warranty being subject to the provisions of Section 5.1, Section 2.7(c) and Section 2.7(d) and the limitations contained in Section 3.3.

 

(b)                                 Adulteration: Misbranding.  Subject to ALAVEN’s obligations with respect to supplies of the Labeling Specifications under Section 2.6 hereof, no Products supplied by ANI to ALAVEN under this Agreement shall, at the time of delivery to the carrier FOB ANI’s Shipping Point, be adulterated or misbranded within the meaning of the Act or be an article which may not be introduced into interstate commerce under the provisions of Section 505 of the Act.

 

9

 

(c)                                  Organization; Standing.  ANI is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite power and authority to own, lease and operate its properties and to carry on its business as now being conducted.

 

(d)                                 Authorization: Binding Effect.  The execution and delivery by ANI of this Agreement, the performance by ANI of its obligations hereunder and the consummation by ANI of the transactions contemplated hereby have been duly authorized by all necessary corporate action on the part of ANI.  This Agreement has been duly executed and delivered by a duly authorized officer of ANI and constitutes the valid and legally binding obligation of ANI enforceable against ANI in accordance with its terms.

 

(e)                                  No Conflict: Consents.  The execution and delivery of this Agreement by ANI will not violate or result in the breach of, constitute a default under, or accelerate the performance required by, any term of any covenant, agreement or understanding to which ANI or any Affiliate is a party, or any Law to which ANI or any Affiliate is subject and (b) no consents or agreements of any third party (including governmental bodies) is necessary for the performance by ANI of its obligations under this Agreement, and ANI has, and at all times will maintain, all necessary Manufacturing Authorizations.

 

3.2                               Representations and Warranties of ALAVEN.  ALAVEN represents and warrants to ANI as follows:

 

(a)                                 Organization: Standing.  ALAVEN is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite power and authority to own, lease and operate its properties and to carry on its business as now being conducted.

 

(b)                                 Authorization: Binding Effect.  The execution and delivery by ALAVEN of this Agreement, the performance by ALAVEN of its obligations hereunder and the consummation by ALAVEN of the transactions contemplated hereby have been duly authorized by all necessary action on the part of ALAVEN.  This Agreement has been duly executed and delivered by a duly authorized officer of ALAVEN and constitutes the valid and legally binding obligation of ALAVEN enforceable against ALAVEN in accordance with its terms.

 

(c)                                  No Conflict: Consents.  The execution and delivery of this Agreement by ALAVEN will not violate or result in the breach of, constitute a default under, or accelerate the performance required by, any term of any covenant, agreement or understanding to which ALAVEN or any Affiliate is a party, or any Law to which ALAVEN or any Affiliate is subject and (b) no consents or agreements of any third party (including governmental bodies) is necessary for the performance by ALAVEN of its obligations under this Agreement.

 

3.3                               Limitations.

 

(a)                                 EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, THE PARTIES AGREE THAT ANI MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS, IMPLIED OR OTHERWISE, AND SPECIFICALLY DISCLAIMS AND SHALL NOT BE LIABLE TO ALAVEN OR OTHERS IN RESPECT OF:

 

(i)                                     ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCTS, WHETHER USED ALONE OR IN COMBINATION WITH OTHER SUBSTANCES OR MATERIALS;

 

10

 

(ii)           ANY LIABILITY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (OTHER THAN TO THE EXTENT REASONABLY FORESEEABLE IN LIGHT OF THE OBJECTIVES OF THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT AND THE ASSET PURCHASE AGREEMENT, BUT SUBJECT TO THE FURTHER LIMITATIONS IN SECTION 3.3(C) BELOW), WHETHER ARISING OUT OF A BREACH OF THE REPRESENTATIONS AND WARRANTIES CONTAINED HEREIN OR OTHERWISE AND WHETHER IN CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE; AND

 

(iii)          ANY LIABILITY TO THE EXTENT ARISING AS A RESULT OF PRODUCTS:  (I) HAVING BEEN TAMPERED WITH OTHER THAN BY ANI OR ITS AGENTS, (II) HAVING BEEN SUBJECT TO MISUSE, NEGLIGENCE OR ACCIDENT OTHER THAN BY ANI OR ITS AGENTS, (III) HAVING BEEN STORED, HANDLED OR USED OTHER THAN BY ANI OR ITS AGENTS IN A MANNER CONTRARY TO REGULATORY STANDARDS OR THE INSTRUCTIONS CONTAINED ON LABELING, OR (IV) HAVING EXCEEDED ITS STATED EXPIRATION.

 

(b)           THE MAXIMUM AGGREGATE LIABILITY OF EITHER PARTY UNDER THIS AGREEMENT SHALL NOT EXCEED [***].

 

(c)           NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, NONE OF THE LIMITATIONS ON LIABILITY SET FORTH IN THIS SECTION SHALL APPLY TO ACTS OR OMISSIONS OF ANI TAKEN OR OMITTED TO BE TAKEN WITH INTENT TO BREACH THE REPRESENTATIONS, WARRANTIES OR OBLIGATIONS OF ANI UNDER THIS AGREEMENT.

 

ARTICLE IV
 TERM AND TERMINATION

 

4.1          Term.  This Agreement shall become effective as of the date hereof and shall continue until five (5) years following the Effective Date (the “Initial Term”), unless terminated earlier by mutual agreement of the parties or by one of the parties in accordance with this Article IV; provided further that ALAVEN shall have the option, in its sole discretion, (a) to terminate this Agreement in the event the Closing Date has not occurred on or prior to June 30, 2007 and (b) to extend the Initial Term of this Agreement for three (3) successive terms of one (1) year each (each a “Renewal Term” and collectively with the Initial Term, the “Term”) by providing ANI written notice of such election not less than six (6) months prior to the expiration of the Initial Term or then current Renewal Term.

 

4.2          Termination By Mutual Agreement.  The parties may terminate this Agreement any time by mutual written agreement.

 

4.3          Termination Upon Material Breach.  Subject to the last two sentences of this Section 4.3, either party may terminate this Agreement upon not less than sixty (60) days written notice thereof to the other party of the material breach by the other party of any of its representations, warranties, covenants or agreements contained in this Agreement (provided, however, that the breaching party may extend such notice period by up to thirty (30) additional days upon its written certification that (i) such breach is not reasonably capable of being cured within such 60-day period and (ii) it has commenced and is diligently pursuing efforts to cure such breach).  Upon the expiration of such notice period, this Agreement shall terminate without the need for further action by either party; provided, however, that if the breach upon which such notice of termination is based shall have been fully cured to the reasonable satisfaction of the non-breaching party within such notice period, then such notice of termination shall be deemed rescinded, and this Agreement shall be deemed reinstated and in full force and effect.  Such right of termination shall 

 

11

 

be in addition to such other rights and remedies as the terminating party may have under any Law.  The time periods for termination stated above in this Section 4.3, shall be suspended during the period commencing upon a bona fide dispute arising between the parties as to whether a material breach has occurred and ending upon the date such dispute is finally determined.  In the event such final determination provides for the payment of money and such amount is paid in full by the obligor within ten (10) days of such determination, no termination right shall arise hereunder with respect to the matter in question.

 

4.4          Rights and Duties Upon Termination.

 

(a)           Supply and Purchase of Products.  Unless otherwise mutually agreed by the parties, ANI shall supply, and ALAVEN shall purchase in accordance with the provisions hereof, all quantities of Products ordered by ALAVEN hereunder prior to the date of expiration or termination; provided, however, that ANI shall not be required to supply volumes of Products which exceed the amounts for which ANI is responsible under the forecast and firm order procedures herein for the balance of the Calendar Quarter in which the termination occurs.  In addition, ALAVEN shall remain liable for and shall duly pay all costs incurred prior to the effective date of expiration or termination which are properly chargeable to ALAVEN pursuant to the terms of this Agreement.  ALAVEN shall have the right to use and sell any such Products in the ordinary course including Products which may contain reference to ANI.

 

(b)           Purchase of Additional Materials and Equipment.  Upon the expiration or termination of this Agreement, ALAVEN shall, if so requested by ANI, purchase (i) all dedicated raw and packaging materials acquired by ANI hereunder to manufacture the Products, at ANI’s actual cost thereof, (ii) all work-in-progress of the Products at ANI’s actual cost thereof, and (iii) all inventory of finished Products then in ANI’s possession at the then-current purchase price hereunder.  In addition, ALAVEN shall pay ANI the actual out of pocket cost for any non-cancelable commitments made by ANI for materials hereunder.  Notwithstanding anything to the contrary in the preceding two sentences, the foregoing purchase and payment obligations of ALAVEN shall be limited solely to materials obtained, Products manufactured and non-cancelable commitments incurred by ANI for quantities of the Products as to which ALAVEN’s forecasts under Section 2.2 hereof constitute a firm commitment or for which purchase orders have been received and which, in the case of Products, comply with the Product Specifications and all Manufacturing Standards.  All materials purchased by ALAVEN become the property of ALAVEN and ANI will, at the request of ALAVEN, arrange to ship such materials to locations designated by ALAVEN.  The cost of the freight shall be borne by ALAVEN.  The foregoing purchase and payment obligations shall not apply in the event of a termination by ALAVEN based on a breach by ANI of its supply obligations.  In addition, upon request from ALAVEN, which request shall [***], ANI shall be obligated to promptly sell to ALAVEN such of the following equipment [***]: (i) the machinery used by ANI to produce the [***], at a price of not more than [***]; (ii) the [***] at a price of not more than [***]; and (iii) the [***] at a price of not more than [***] at the time of sale to ALAVEN.

 

(c)           Tooling: Upon any termination of this Agreement by either party for any reason, all Tooling shall be promptly returned to ALAVEN.

 

ARTICLE V
 INDEMNIFICATION

 

5.1          By ANI.  Subject to the limitations described in Section 3.3, ANI shall defend, indemnify and hold harmless ALAVEN and its Affiliates, successors, permitted assigns and their respective officers, directors, managers, members, stockholders, partners and employees from and against any and all Claims arising out of (a) any breach of any representation, warranty or covenant of ANI hereunder, (b) any 

 

12

 

negligent storage or handling of the Products by ANI prior to delivery to ALAVEN FOB ANI’s Shipping Point, (c) any negligent act or omission of ANI or its employees, agents or other contractors with respect to the Products, (d) the failure of ANI to comply with any applicable Regulatory Standards with respect to the manufacture or storage, or (e) all personal injury (including death) and/or property damage resulting from the manufacture, handling, or possession of the Products prior to ANI’s delivery of the Products to ALAVEN FOB ANI’s Shipping Point.  For purposes of this Agreement, “Claims” shall mean any and all liabilities and expenses whatsoever, including, without limitation, claims, adversary proceedings (whether before a court, Regulatory Authority or any other tribunal), damages (other than special, incidental, consequential or punitive damages except to the extent awarded to a third party), judgments, awards, penalties, settlements, investigations, costs, and attorneys’ fees and disbursements.

 

5.2          By ALAVEN.  Subject to the limitations set forth in Section 3.3, ALAVEN shall defend, indemnify and hold harmless ANI and its Affiliates, successors, permitted assigns and their respective officers, directors, stockholders, partners and employees from and against any and all Claims arising out of (a) any breach of any representation, warranty or covenant of ALAVEN hereunder, (b) any negligent act or omission of ALAVEN or its employees, agents or other contractors with respect to the Products, (c) the failure of ALAVEN to comply with any applicable Regulatory Standards with respect to the importation, marketing, distribution or sale of the Products, (d) any Labeling for the Products approved by ALAVEN, (e) the infringement of any patent, trademark or other intellectual property rights by the sale or use of the Products, or (f) all personal injury (including death) and/or property damage resulting from the handling, possession, marketing, promotion or use of the Products following ANI’s delivery of the Products to ALAVEN FOB ANI’s Shipping Point.  Notwithstanding the preceding sentence, ALAVEN shall not be required to indemnify ANI with respect to any Claim arising from ANI’s breach of its representations, warranties or covenants hereunder or under the Asset Purchase Agreement or ANI’s willful misconduct with respect to the Products.

 

5.3          Procedure.  Any person or entity intending to claim indemnification hereunder (an “Indemnitee”) shall notify the party hereunder from whom indemnification is sought (the “Indemnitor”) in writing within a reasonable time of any third-party Claim for which indemnification is sought hereunder.  The failure to give timely notice to the Indemnitor shall not release the Indemnitor from any liability to the Indemnitee to the extent the Indemnitor is not prejudiced thereby.  The Indemnitor shall have the right, by notice to the Indemnitee within fifteen (15) business days after the Indemnitor’s receipt of notice thereof, to assume the defense of any such third-party Claim with counsel of the Indemnitor’s choice and at Indemnitor’s sole expense.  If the Indemnitor so assumes such defense, the Indemnitee may participate therein through counsel of its choice, but at its sole expense.  The party not assuming the defense of the third-party Claim shall render all reasonable assistance to the party assuming the defense, and all reasonable out-of-pocket costs of such assistance shall be for the account of the Indemnitor.  No such third-party Claim shall be settled other than by the party defending it, and then only with the consent of the other party (which shall not be unreasonably withheld or delayed).  The Indemnitee shall, however, have no obligation to consent to any settlement which imposes on the Indemnitee any liability or obligation which cannot be assumed and performed in full by the Indemnitor, and the Indemnitee shall have no right to withhold its consent to any settlement which involves only the payment of money by the Indemnitor or its insurer.

 

ARTICLE VI
 ADVERSE EVENT REPORTS

 

Subject to the terms of the Asset Purchase Agreement, ALAVEN shall be solely responsible for receiving, recording and responding to all customer inquiries and complaints and all reports of alleged adverse events relating to the Products, and for reporting all such matters to appropriate Regulatory Authorities in accordance with applicable law.  ANI shall provide ALAVEN with any technical 

 

13

 

information relating to formulation, manufacture or stability of the Products necessary to enable ALAVEN to perform all such activities and to determine whether the adverse event, customer inquiry or complaint involves a Nonconformance, Latent Defect or necessitates a recall or other corrective or market action.  Should ANI receive any notice or inquiry regarding adverse events, it shall transmit them to ALAVEN within 24 hours.

 

ARTICLE VII
 CONFIDENTIALITY

 

7.1          Generally.  Each party shall hold all Confidential Information disclosed to it by the other in the strictest confidence and shall protect all such Confidential Information with the same degree of care that it exercises with respect to its own proprietary information.  Without the prior written consent of the disclosing entity, the receiving party shall neither use, disclose, divulge nor otherwise disseminate any Confidential Information to any person or entity outside of the party, except for the receiving party’s attorney and such other professionals as the receiving party may retain in order for it to enforce the provisions of this Agreement.  For purposes of this Agreement, “Confidential Information” shall consist of any information, whether or not reduced to writing, which either party shall from time to time possess in relation to the development, formulation, manufacture, testing or packaging of the Products and which is not generally known to the public or within the pharmaceutical industry and which one party hereto discloses to the other party.

 

7.2          Restriction.  Neither party shall use the other’s name or disclose the existence or terms of this Agreement without the written permission of the other except for references in Products packaging or labeling required by law or otherwise contemplated herein or in the Asset Purchase Agreement or the Transition Services Agreement (as defined in the Asset Purchase Agreement).

 

7.3          Exceptions.  Notwithstanding Section 7.1 hereof, neither party shall have any obligations with respect to any Confidential Information which (a) is or becomes within the public domain through no act of the receiving party in breach of this Agreement, (b) was lawfully in the possession of the receiving party without any restriction on use or disclosure prior to its disclosure hereunder, (c) is lawfully received from another source subsequent to the date of this Agreement without any restriction on use or disclosure, (d) is deemed in writing by the disclosing entity no longer to be Confidential Information, or (e) is required to be disclosed by order of any court of competent jurisdiction or other governmental authority (provided, however, in such latter case, that the receiving party shall timely inform the disclosing party of all such legal or governmental proceedings so that the disclosing party may attempt by appropriate legal means to limit such disclosure, and the receiving party shall further use its reasonable best efforts to limit the disclosure and maintain confidentiality to the maximum extent possible).

 

ARTICLE VIII
 COOPERATION WITH GOVERNMENTAL REQUIREMENTS

 

The parties shall cooperate with one another as may be reasonably necessary or appropriate to satisfy all governmental requirements and obtain all needed permits, approvals and licenses with respect to the manufacture, storage, packaging and sale of the Products.  Such cooperation shall include, without limitation, communicating with Regulatory Authorities and making available as promptly as reasonably practicable all information, documents and other materials which result from the performance by ANI of its obligations hereunder which ALAVEN is required to submit.  The costs and expenses of such cooperation, if applicable, shall be subject to the parties’ mutual agreement.  ALAVEN shall be responsible for all regulatory reporting of Products.  ANI shall assist ALAVEN by providing necessary support and information and shall prepare the annual cGMP Products reviews.

 

14

 

ARTICLE IX
 FORCE MAJEURE

 

9.1          Effects of Force Maieure.  Notwithstanding any other provision of this Agreement to the contrary, neither party shall be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement to the extent that such failure or delay results from any cause beyond its reasonable control, including, without limitation, fire, flood, explosion, war, strike, labor unrest, riot, embargo, inability to obtain necessary raw materials or supplies, acts or omissions of carriers, or act of God (each, a “Force Majeure Event”).  Subject to Section 9.4, such excuse shall continue as long as the Force Majeure Event continues, following which such party shall promptly resume performance hereunder.

 

9.2          Effects of Regulatory Changes.  Notwithstanding any other provision of this Agreement to the contrary, neither party shall be held responsible or liable for failure or delay in fulfilling or performing any of its obligations under this Agreement to the extent that such failure or delay results from good faith efforts to comply with the enactment or revision of any law, rule, regulation or regulatory advisory opinion or order applicable to the manufacturing, marketing, sale, reimbursement and/or pricing of the Products (a “Regulatory Change”).  Such excuse shall continue as long as performance is prevented by the affected party’s good faith efforts to comply with such Regulatory Change, following which such party shall promptly resume performance hereunder.

 

9.3          Notice.  The party affected by a Force Majeure Event or a Regulatory Change shall notify the other party thereof as promptly as practicable after its occurrence.  Such notice shall describe the nature of such Force Majeure Event or Regulatory Change and the extent and expected duration of the affected party’s inability fully to perform its obligations hereunder.  The affected party shall use all reasonable efforts to minimize the effects of or end any such event so as to facilitate the resumption of full performance hereunder and shall notify the other party when it is again fully able to perform such obligations.

 

9.4          Limitation.  Notwithstanding anything to the contrary herein, in the event a Regulatory Change or Force Majeure Event continues for more than 90 days, ALAVEN shall have the right to terminate this Agreement upon notice and upon ALAVEN’s request, ANI shall cooperate to assist in the transfer of technology to a new manufacturer at no additional labor cost to ALAVEN.  ALAVEN shall bear the cost and expense of the foregoing technology transfer in the case of a Regulatory Change, and the parties shall bear the cost and expense of a technology transfer in such proportion as is just and equitable in the case of a Force Majeure Event.

 

ARTICLE X
 INDEPENDENT CONTRACTORS

 

The relationship between ANI and ALAVEN is that of independent contractors, and nothing herein shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between ANI and ALAVEN.  Neither party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

 

ARTICLE XI
 FURTHER ACTIONS

 

The parties shall execute such additional documents and perform all such other and further acts as may be necessary to carry out the purposes and intents of this Agreement.

 

15

 

ARTICLE XII
 DISPUTE RESOLUTION

 

12.1        Negotiation.  Any dispute, controversy or claim arising out of or relating to this Agreement or the breach, termination, or invalidity hereof shall be submitted for negotiation and settlement in the first instance to the Chief Operating Officer of ANI, or such person’s designee of equivalent or superior position, and the Chief Operating Officer of ALAVEN, or such person’s designee of equivalent or superior position.

 

12.2        Arbitration.  If the parties are unable to settle a dispute, controversy or claim hereunder pursuant to Section 12.1, the matter shall be finally resolved by arbitration in accordance with the rules of American Arbitration Association, except as modified by this Section 12.2.  The number of arbitrators shall be three (3), one (1) of whom is selected by ALAVEN, one (1) of whom is selected by ANI and one (1) of whom is selected by ANI and ALAVEN (or by the other two (2) arbitrators if the parties cannot agree).  The arbitration proceeding shall be conducted in the English language.  The arbitration proceeding shall be brought in the State of Delaware, unless the parties agree in writing to conduct the arbitration in another location.  The arbitration decision shall be binding and not be appealable to any court in any jurisdiction.  The prevailing party may enter such decision in any court having competent jurisdiction.  Each party shall pay its own expenses of arbitration and the expenses of the arbitrators shall be equally shared except that if, in the opinion of the arbitrators, any claim by a party hereto or any defense or objection thereto by the other party was unreasonable, the arbitrators may in their discretion assess as part of the award any part of the arbitration expenses of the other party (including reasonable attorneys’ fees) and expenses of the arbitrators against the party raising such unreasonable claim, defense or objection.

 

12.3        Interim Relief.  Any party may, without inconsistency with this Agreement, apply to any court having jurisdiction hereof and seek injunctive relief so as to maintain the status quo until such time as the arbitration award is rendered or the controversy is otherwise resolved.

 

ARTICLE XIII
 MISCELLANEOUS

 

13.1        Notices.  All notices, requests, instructions, consents and other communications to be given pursuant to this Agreement shall be in writing and shall be deemed received (a) on the same day if delivered in person, by same-day courier or by telegraph, telex, facsimile, electronic mail or other electronic transmission, (b) on the next day if delivered by overnight mail or courier, or (c) on the date indicated on the return receipt, or if there is no such receipt, on the third calendar day (excluding Sundays) if delivered by certified or registered mail, postage prepaid, to the party for whom intended to the following addresses:

 

If to ALAVEN:

 

ALAVEN Pharmaceutical, LLC
 2260 Northwest Parkway, Suite A
 Marietta, GA 30067
 Attn:  CEO

 

With a copy to:

 

Burke, Warren, MacKay & Serritella, P.C.
 330 N.  Wabash Avenue, Suite 2200

 

16

 

Chicago, IL 60611
 Attn:  Christopher R.  Manning

 

If to ANI:

 

ANIP Acquisition Company
 d/b/a ANI Pharmaceuticals, Inc.
 7131 Ambassador Road, Suite 150
 Woodlawn, MD 21244
 Attention:  President & CEO

 

With a copy to:

 

Sonnenschein Nath & Rosenthal LLP
 1221 Avenue of the Americas
 25th Floor
 New York, NY 10020
 Attn:  Ms.  Jane A.  Meyer

 

Each party may by written notice given to the other in accordance with this Agreement change the address to which notices to such party are to be delivered.

 

13.2        Entire Agreement.  This Agreement and the agreements being executed contemporaneously herewith contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, whether written or oral, between them with respect to the subject matter hereof and thereof.  Each party has executed this Agreement without reliance upon any promise, representation or warranty other than those expressly set forth herein and in such other agreements.

 

13.3        Amendment.  No amendment of this Agreement shall be effective unless embodied in a written instrument executed by both of the parties.

 

13.4        Waiver of Breach.  The failure of either party at any time to enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision, nor in any way to affect the validity of this Agreement or any provisions hereof or the right of any party hereto to thereafter enforce each and every provision of this Agreement.  No waiver of any breach of any of the provisions of this Agreement shall be effective unless set forth in a written instrument executed by the party against whom or which enforcement of such waiver is sought; and no waiver of any such breach shall be construed or deemed to be a waiver of any other or subsequent breach.

 

13.5        Assignability.  ANI may assign this agreement with the consent of ALAVEN, which consent will not be unreasonably withheld.  ALAVEN shall have the right to assign all of its right, title and interest hereunder to any third party.  In the event that this Agreement is assigned by ALAVEN to a competitor of ANI, ANI shall have the right to increase the price charged for Products hereunder to include a conventional contract manufacturer’s profit.  This Agreement shall be binding upon and inure to the benefit of the parties, their successors and permitted assigns.

 

13.6        Governing Law; Jurisdiction.  This Agreement shall be governed by and construed in accordance with the laws of Delaware without regard to its conflicts of laws principles.  The parties consent to the personal jurisdiction and venue of the United States Federal Courts and further consent that any process, notice of motion or other application to either such court or a judge thereof may be served by 

 

17

 

registered or certified mail or by personal service, provided that a reasonable time for appearance is allowed.

 

13.7        Severability.  All of the provisions of this Agreement are intended to be distinct and severable.  If any provision of this Agreement is or is declared to be invalid or unenforceable in any jurisdiction, it shall be ineffective in such jurisdiction only to the extent of such invalidity or unenforceability.  Such invalidity or unenforceability shall not affect either the balance of such provision, to the extent it is not invalid or unenforceable, or the remaining provisions hereof, nor render invalid or unenforceable such provision in any other jurisdiction.

 

13.8        Publicity.  Neither party shall issue any press release or make any similar public announcement concerning the transactions contemplated in this Agreement, except as may be required by law (including federal securities law) or judicial order, without the prior written consent of the other party.  Neither party shall issue any press release or make any similar announcement which includes the name of the other party or its affiliates or otherwise uses the name of the other party in any public statement or publicly released document except as required by law (including federal securities law) or with the prior written consent of the other party.

 

13.9        Survival.  The provisions of Section 2.5 (Delivery), Section 2.7 (Inspection of Products), Section 2.9 (Recalls), Section 3 (Representation and Warranties), Section 4.4 (Rights and Duties Upon Termination), Article V (Indemnification), Article VI (Adverse Event Reports), Article VII (Confidentiality), Section 13.6 (Governing Law; Jurisdiction), Section 13.8 (Publicity) and this Section 13.9 (Survival) shall survive the termination or expiration of this Agreement for any reason.

 

13.10      Headings.  The headings of sections and subsections have been included for convenience only and shall not be considered in interpreting this Agreement.

 

13.11      Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, and all of which together shall constitute one and the same Agreement.  This Agreement may be executed and delivered via electronic facsimile transmission with the same force and effect as if it were executed and delivered by the parties simultaneously in the presence of one another.

 

13.12      Execution.  At the time of execution of this Agreement, the parties shall cause their authorized officers to execute two original copies of this Agreement, one copy of which shall be maintained by each party at that party’s offices.  Each party represents that the person who executes this Agreement is authorized and empowered to obligate and bind his party under this Agreement.

 

13.13      Facsimile Signatures.  Any counterpart of this Agreement may be signed and transmitted by facsimile with the same force and effect as if such counterpart was an ink-signed original.

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed on the date first written above.

 

	
ANI PHARMACEUTICALS, INC.
    	
 
    	
ALAVEN PHARMACEUTICAL, LLC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Thomas L. Anderson
    	
 
    	
By:
    	
/s/ William Campbell
    
	
Name:
    	
Thomas L. Anderson
    	
 
    	
Name:
    	
William Campbell
    
	
Title:
    	
President & CEO
    	
 
    	
Title:
    	
VP & CFO
    
	
Date:
    	
June 10, 2008
    	
 
    	
Date:
    	
6/13/2008
    

 

18

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

EXHIBIT A

 

Amended and Restated

 

Initial Product Quantity and Purchase Price

 

Manufacture and Packaging

 

	
PRODUCT
    	
 
    	
SIZE
    	
 
    	
NDA#
    	
 
    	
BATCH
   QTY
    	
 
    	
PRICE/Unit
    	
 
    	
2007 Annual
   Units
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

* Price Based on [***]

 

** Price for [***]

 

A-1

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

EXHIBIT B

 

AMENDED AND RESTATED LABELING SPECIFICATIONS

 

[NOT ATTACHED TO EXECUTED AGREEMENT]

 

B-1

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

EXHIBIT C

 

AMENDED AND RESTATED PRODUCTS SPECIFICATIONS

 

[NOT ATTACHED TO EXECUTED AGREEMENT]

 

C-1

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

EXHIBIT D

 

QUALITY AGREEMENT

 

[NOT ATTACHED TO EXECUTED AGREEMENT]

 

D-1

 

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended.  Confidential Portions are marked:  [***]

 

EXHIBIT E

 

[***](1)

 

	
 
    	
 
    	
TIME - 0
    	
 
    	
TIME - 1
    	
 
    	
TIME - 2
    	
 
    	
TIME - 3
    	
 
    	
TIME - 6
    	
 
    	
TIME - 9
    	
 
    	
TIME - 12
    	
 
    	
TIME - 18
    	
 
    	
TIME - 24
    	
 
    	
TOTAL
    
	
INITIAL STABILITY PROGRAM
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
MFG. OF FIRST THREE PRODUCTS(2)
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

·                  Costs Reflect Ongoing Manufacturing of [***]

·                  Lab test cost/hrs subject to annual review for hourly rate, materials and man hours

·                  Rate is based upon estimated lab cost.  Actual hours and out of pocket cost will be Invoiced

 

(1)  [***]

(2)  [***]

 

E-1

 

EXHIBIT F

 

[***]

 

[***]

 

	
 
    	
 
    	
Responsibility
    
	
Task
    	
 
    	
Alaven
    	
 
    	
ANI
    	
 
    	
[***]
    
	
1
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
2
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
3
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
4
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
5
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
6
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
7
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
8
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
9
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
10
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
11
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
12
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
13
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
14
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
15
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
16
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
17
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
18
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
19
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
20
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
21
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

F-1

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00210-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00210-of-00352.parquet"}]]