Looking for an agreement? Search from over 1 million agreements now.

Collaboration, License & Supply Agreement 12-8-00

This is an actual contract between QLT and Atrix.

Save time and money with our Premium Packages.
Buy all (8) recommended agreements for
$140.00 (50% savings)
Agreement Preview
Search This Document
EXHIBIT 10.19


CONFIDENTIAL TREATMENT REQUESTED BY QLT INC.


COLLABORATION, LICENSE AND SUPPLY AGREEMENT


BETWEEN


ATRIX LABORATORIES, INC.


AND


SANOFI-SYNTHELABO INC.


TABLE OF CONTENTS


SECTION PAGE NO. - ------- -------- Article I DEFINITIONS........................................................... 1


Article II COLLABORATION........................................................ 8 Section 2.01. Objectives..................................................... 8 Section 2.02. Development Program............................................ 8 Section 2.03. Atrix Obligations.............................................. 9 Section 2.04. Sanofi-Synthelabo Obligations.................................. 9 Section 2.05. Availability of Resources; Cooperation......................... 9


Article III LICENSE............................................................. 10 Section 3.01. License Fee.................................................... 10 Section 3.02. License Terms.................................................. 10 Section 3.03. Marks.......................................................... 11


Article IV ROYALTY AND MILESTONE PAYMENTS....................................... 11 Section 4.01. Research and Development Expenses.............................. 11 Section 4.02. Royalty Payments............................................... 11 Section 4.03. Milestone Payments............................................. 11 Section 4.04. Additional Milestone Payments.................................. 11 Section 4.05. Reports........................................................ 11


Article V NEW PRODUCT........................................................... 13 Section 5.01. New Product.................................................... 13 Section 5.02. Right of First Negotiation..................................... 13


Article VI COMMERCIALIZATION.................................................... 14 Section 6.01. Promotion And Marketing Obligations............................ 14


Article VII MANUFACTURE AND SUPPLY.............................................. 16 Section 7.01. Agreement to Supply Product.................................... 16 Section 7.02. Quality Assurance.............................................. 16 Section 7.03. Atrix's Duties................................................. 17 Section 7.04. Compliance with Applicable Laws................................ 18 Section 7.05. Second Manufacturing Source.................................... 18 Section 7.06. Failure to Supply.............................................. 18 Section 7.07. Allocation..................................................... 19


Article VIII PURCHASE AND SALE.................................................. 19 Section 8.01. Purchase Price and Payment..................................... 19 Section 8.02. Adjustment to Purchase Price/Audit............................. 20 Section 8.03. Labeling....................................................... 21 Section 8.04. Purchase Forms................................................. 21 Section 8.05. Confirmation................................................... 21


Section 8.06. Delivery....................................................... 21 Section 8.07. Forecasts and Orders........................................... 21 Section 8.08. Demonstration Samples.......................................... 23


Article IX WARRANTY, REJECTION AND INSPECTIONS.................................. 23 Section 9.01. Atrix Warranty................................................. 23 Section 9.02. Rejection of Product for Failure to Conform to Specifications.. 23 Section 9.03. Sanofi-Synthelabo Inspections.................................. 24


Article X REGULATORY COMPLIANCE................................................. 24 Section 10.01. Marketing Authorization Holder................................. 24 Section 10.02. Maintenance Of Marketing Authorizations........................ 24 Section 10.03. Interaction with Competent Authorities......................... 24 Section 10.04. Adverse Drug Event Reporting and Phase IV Surveillance......... 25 Section 10.05. Post - First Commercial Sale Testing And Reporting............. 26 Section 10.06. Assistance..................................................... 26 Section 10.07. Compliance..................................................... 26


Article XI PATENTS AND TRADEMARKS............................................... 27 Section 11.01. Maintenance of Patents or Marks................................ 27 Section 11.02. Cooperation.................................................... 27 Section 11.03. Atrix to Prosecute Infringement................................ 27 Section 11.04. Infringement Claimed by Third Parties.......................... 28


Article XII CONFIDENTIALITY..................................................... 28 Section 12.01. Confidentiality................................................ 28 Section 12.02. Disclosure of Agreement........................................ 28


Article XIII ATRIX'S OPTION TO MARKET THE PRODUCT UNDER CERTAIN CIRCUMSTANCES... 29 Section 13.01. Co-Marketing Rights............................................ 29


Article XIV REPRESENTATIONS AND WARRANTIES...................................... 29 Section 14.01. Corporate Power................................................ 29 Section 14.02. Due Authorization.............................................. 29 Section 14.03. Binding Obligation............................................. 29 Section 14.04. Ownership of Atrigel(R) Patent Rights.......................... 30 Section 14.05. Patent Proceedings............................................. 30 Section 14.06. Legal Proceedings.............................................. 30 Section 14.07. Atrix's Manufacturing Facility................................. 30 Section 14.08. Limitation on Warranties....................................... 30 Section 14.09. Limitation of Liability........................................ 30


Article XV INDEMNIFICATION...................................................... 31 Section 15.01. Sanofi-Synthelabo Indemnified by Atrix......................... 31 Section 15.02. Atrix Indemnified by Sanofi-Synthelabo......................... 31 Section 15.03. Prompt Notice Required......................................... 31 Section 15.04. Indemnitor May Settle.......................................... 31


Article XVI COVENANTS........................................................... 32 Section 16.01. Covenant Not To Launch Competitive Product..................... 32 Section 16.02. Limitation To The Territory.................................... 33


ii


Section 16.03. Access to Books and Records.................................... 33 Section 16.04. A&S Spending Levels............................................ 33 Section 16.05. Marketing Expenses............................................. 34 Section 16.06. Compliance..................................................... 34 Section 16.07. Protection of the Marks........................................ 34 Section 16.08. Launch Quantities.............................................. 34 Section 16.09. Further Actions................................................ 34


Article XVII PRODUCT RECALL..................................................... 35 Section 17.01. Product Recalls or Withdrawal.................................. 35 Section 17.02. Recall Costs................................................... 35 Section 17.03. Notification Of Complaints..................................... 36 Section 17.04. Notification Of Threatened Action.............................. 36


Article XVIII INSURANCE......................................................... 36 Section 18.01. Insurance...................................................... 36


Article XIX TERM; DEFAULT AND TERMINATION....................................... 37 Section 19.01. Term........................................................... 37 Section 19.02. Termination by Either Party.................................... 37 Section 19.03. Termination by Either Party for Cause.......................... 37 Section 19.04. Termination by Atrix........................................... 37 Section 19.05. Termination by Sanofi-Synthelabo............................... 38 Section 19.06. Remedies....................................................... 38 Section 19.07. Effect of Termination.......................................... 38


Article XX MISCELLANEOUS........................................................ 41 Section 20.01. No-Solicitation................................................ 41 Section 20.02. Commercially Reasonable Efforts................................ 41 Section 20.03. Assignment..................................................... 41 Section 20.04. Force Majeure.................................................. 41 Section 20.05. Governing Law.................................................. 42 Section 20.06. Waiver......................................................... 42 Section 20.07. Severability................................................... 42 Section 20.08. Notices........................................................ 42 Section 20.09. Independent Contractors........................................ 43 Section 20.10. Rules of Construction.......................................... 43 Section 20.11. Publicity...................................................... 43 Section 20.12. Entire Agreement; Amendment.................................... 43 Section 20.13. Headings....................................................... 44 Section 20.14. Counterparts................................................... 44


Exhibit A - Atrigel(R) Patent Rights............................................ A-1 Exhibit B - Form of Certificate of Compliance................................... B-1 Exhibit C - Specifications...................................................... C-1 Exhibit D - Form of Stock Purchase Agreement.................................... D-1 Exhibit E - Development Program................................................. E-1 Exhibit F - Sanofi-Synthelabo's SOP............................................. F-1 Exhibit G - Six Month Product Development Program............................... G-1


iii


COLLABORATION, LICENSE AND SUPPLY AGREEMENT


This Collaboration, License and Supply Agreement (the "Agreement") is made as of December 8, 2000 by and between Atrix Laboratories, Inc., a Delaware corporation having offices at 2579 Midpoint Drive, Fort Collins, CO, 80525-4417 ("Atrix"), and Sanofi-Synthelabo Inc. a Delaware corporation having offices at 90 Park Avenue, New York, NY, 10016 ("Sanofi-Synthelabo"). Atrix and Sanofi-Synthelabo are sometimes referred to collectively herein as the "Parties" or singly as a "Party."


RECITALS


WHEREAS, Atrix possesses proprietary drug delivery systems including "Atrigel(R)" and has substantial experience and expertise in the discovery, design and development of products based on these proprietary drug delivery systems for medical, dental and veterinary applications;


WHEREAS, Sanofi-Synthelabo possesses substantial resources and expertise in the development, commercialization and marketing of pharmaceutical products;


WHEREAS, Atrix wishes to grant to Sanofi-Synthelabo, and Sanofi-Synthelabo wishes to obtain from Atrix, an exclusive license under Atrix's Atrigel(R) Technology to market, advertise, promote, distribute, offer for sale, sell and import the Product in the Territory for use in the Field on the terms and subject to the conditions set forth herein; and


WHEREAS, Sanofi-Synthelabo wishes Atrix to manufacture and Atrix desires to manufacture each of the Product to be sold in the Territory by Sanofi-Synthelabo.


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


AGREEMENT


ARTICLE I


DEFINITIONS


The following terms as used in this Agreement shall, unless the context clearly indicates to the contrary, have the meaning set forth below:


"Acceptance for Filing" means Atrix's receipt of a letter issued by the FDA indicating acceptance for filing of an NDA pursuant to 21 CFR Section 314.101.


"ADE" has the meaning set forth in Section 10.04.


"Affiliate" means an individual, trust, business trust, joint venture, partnership, corporation, association or any other entity which owns, is owned by or is under common ownership with, a Party. For the purposes of this definition, the term "owns" (including, with


1


correlative meanings, the terms "owned by" and "under common ownership with") as used with respect to any Party, shall mean the possession (directly or indirectly) of more than 50% of the outstanding voting securities of a corporation or comparable equity interest in any other type of entity.


"Applicable Laws" means all applicable laws, rules, regulations and guidelines within or without the Territory that may apply to the development, marketing, manufacturing, packaging or sale of the Product in the Territory or the performance of either Party's obligations under this Agreement including laws, regulations and guidelines governing the import, export, development, marketing, distribution and sale of the Product in the Territory, to the extent applicable and relevant, and including all cGMP or Good Clinical Practices standards or guidelines promulgated by the FDA or the Competent Authorities and including trade association guidelines, where applicable, as well as United States' export control laws and the United States' Foreign Corrupt Practices Act.


"Approval Letter" means a letter issued by the FDA indicating approval of a product, as defined in 21 CFR Section 314.105, or a similar letter issued by a Competent Authority in any other country in the Territory.


"A&S" means Sanofi-Synthelabo's advertising and selling expenditures incurred in and associated with the promotional support of the Product, including the creation, development and acquisition of advertising and selling materials, including, but not limited to, expenditures for samples, detailing materials, journal advertising, in-office waiting room materials, educational programs, including Web-site programs for physicians and patients, convention booths, direct mail, consumer support, third party support, managed care programs, post-marketing Phase IV studies to support existing indications, market research, market surveys, market analysis and the training and costs of the pharmaceutical detail force, the medical therapeutic liaisons and the telesales staff used with regard to support of the Product. The costs of warehousing and physical distribution, post-marketing Phase IV studies to support new indications, and discounts given to managed care organizations shall not be considered to be A&S expenses for purposes of this Agreement.


"Atrigel(R)" means Atrix's proprietary drug delivery system consisting of flowable compositions (e.g., solutions, gels, pastes and putties) of biodegradable polymers and biocompatible solvents.


"Atrigel(R) Know-How" means all Know-How related to Atrix's proprietary Atrigel(R) drug delivery system as of the Effective Date, which is not covered by the Atrigel(R) Patent Rights, but is necessary or useful to develop, manufacture and commercialize the Product in the Territory for use in the Field, and which is under the Control of Atrix as of the Effective Date.


"Atrigel(R) Patent Rights" means all Patent Rights related to Atrix's proprietary Atrigel(R) drug delivery system as of the Effective Date and at any time during the Term of this Agreement, which are necessary or appropriate to develop, manufacture and commercialize the Product in the Territory for use in the Field, which are under the Control of Atrix as of the Effective Date and Improvements thereto developed during the Term. The Atrigel(R) Patent Rights as of the Effective Date are set forth on Exhibit A.


2


"Atrigel(R) Technology" means the Atrigel(R) Patent Rights and the Atrigel(R) Know-How.


"Atrix Manufacturing Cost" means the actual cost of the Manufacture by Atrix of the Product under a Manufacturing Process, including the related quality assurance and quality control activities as required by Applicable Laws (other than the costs set forth in Section 2.03), which actual cost shall be comprised of the cost of goods produced as determined in accordance with GAAP, and shall include direct labor, direct material, including raw materials and packaging materials, and the allocable portion of the manufacturing overhead of Atrix directly attributable to the Manufacture of the Product. The allocable portion of the manufacturing overhead shall be determined by taking the total facility cost for the period, less an adjustment for idle capacity, and allocating the remaining facility cost by labor usage to each of the products produced in the facility during the period. For example: If the facility cost for the period was $1,000,000 and it was operating at 80% capacity, the allocable facility cost would be $800,000. If the Product represented 30% of labor usage during the period, the allocable portion of the manufacturing overhead directly attributable to the Manufacture of the Product would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and administrative, research and development, and interest expenses and any and all debt service payments of Atrix. For a period of twelve (12) months from the date of First Commercial Sale of each Product the Atrix Manufacturing Cost for each Product will be set as follows (the "Twelve Month Cost"):


One Month Product - [**]
Three Month Product - [**]
Four Month Product - [**]


"Certificate of Compliance" means the certificate of compliance in the form attached hereto as Exhibit B.


"cGMP" means current good manufacturing practices as defined in 21 CFR Section 110 et seq.


"CMC" means chemistry manufacturing and controls.


"Collaboration" means the activities of the Parties carried out in performance of, and the relationship between the Parties established by, this Agreement.


"Competent Authorities" means collectively the governmental entities in each country in the Territory responsible for the regulation of medicinal products intended for human use.


"Competitive Product" means any leuteinizing hormone releasing hormone (LHRH) or derivative or analog thereof, whether agonist or antagonist, whether naturally-occurring or synthetic, used for the treatment of prostate cancer, endometriosis or uterine fibroids.


"Confidential Information" means any confidential information of a Party relating to any use, process, method, compound, research project, work in process, future development, scientific, engineering, manufacturing, marketing, business plan, financial or personnel matter relating to the disclosing Party, its present or future products, sales, suppliers, customers,


- ---------- ** Confidential Treatment Requested.


3


employees, investors or business, whether in oral, written, graphic or electronic form. Confidential Information shall not include any information which the receiving Party can prove by competent evidence:


is now, or hereafter becomes, through no act or failure to act on the
part of the receiving Party, generally known or available;


is known by the receiving Party at the time of receiving such
information, as evidenced by its written records maintained in the ordinary
course of business;


is hereafter furnished to the receiving Party by a Third Party, as a
matter of right and without restriction on disclosure;


is independently developed by the receiving Party, as evidenced by its
written records, without knowledge of, and without the aid, application or
use of, the disclosing Party's Confidential Information; or


is the subject of a written permission to disclose provided by the
disclosing Party.


"Consumer Price Index" means the Consumer Price Index for all Urban Consumers (Consumer Prices - All Urban Consumers, 1982-84 = 100) as published by the Bureau of Labor Statistics of the Department of Labor of the United States Department of Commerce.


"Control" means the possession of the ability to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.


"Demonstration Samples" means Units, absent leuprolide acetate, used to demonstrate the manner in which the Product is prepared and used, and labeled "demonstration samples, for demonstration purposes only, not for human use."


"Development Program" has the meaning set forth in Section 2.02.


"Effective Date" means 3:00 p.m., Eastern Standard Time on the third business day after any waiting period (and any extension thereof) and/or approvals applicable to the consummation of the Agreement under the HSR Act shall have expired, been terminated or obtained, as applicable.


"FDA" means the United States Food and Drug Administration.


"Field" means the primary indication for the palliative treatment of prostate cancer and the secondary indication for the treatment of endometriosis and uterine fibroids.


"First Commercial Sale" means (i) with respect to a country in the Territory, the first sale for use, consumption or resale of each Product by Sanofi-Synthelabo in such country and (ii) with respect to the Territory, the First Commercial Sale in any country within the Territory. A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end user of the Product.


4


"Four Month Product" means the formulation comprised of leuprolide acetate in an Atrigel(R) delivery system that provides for the sustained release of leuprolide acetate over a period of about one hundred and twenty (120) days and not less than one hundred and twelve (112) days with a primary indication for the palliative treatment of prostate cancer.


"GAAP" means United States generally accepted accounting principles consistently applied on a basis consistent throughout the periods indicated and consistent with each other.


"Good Clinical Practices" means good clinical practices as defined in 21 CFR Section 50 et seq. and Section 312 et seq.


"Governmental Approval" means all permits, licenses and authorizations, including but not limited to, Marketing Authorization and Pricing and Reimbursement Approvals required by the FDA or any other Competent Authority as a prerequisite to the manufacturing, packaging, marketing and selling of the Product or the Units; excluding, however, import permits.


"HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.


"Improvements" means any and all developments, inventions or discoveries in the Field relating to the Atrigel(R) Technology developed, or acquired by Atrix at any time during the Term and shall include, but not be limited to, developments intended to enhance the safety and/or efficacy of the Product.


"Know-How" means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not generally publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information.


"Launch Quantity" means a quantity of Product adequate to meet the requirements set forth for the first six (6) months in the initial forecast to be provided by Sanofi-Synthelabo to Atrix as provided in Section 8.07.


"Manufacture" or "Manufacturing Process" means the storage, handling, production, processing and packaging of a Product or a Demonstration Sample, in accordance with this Agreement.


"Marketing Authorization" means all necessary and appropriate regulatory approvals, excluding Pricing and Reimbursement Approvals, where applicable, to put the Product on the market in a particular country in the Territory.


"Marks" means "Atrigel(R)" or "Leuprogel(TM)" or any additional trademarks selected by the Parties pursuant to Section 6.01(b) in either case, alone or accompanied by any logo or design and any foreign language equivalents in sound or meaning, whether registered or not.


"NDA" means a New Drug Application, and all amendments and supplements thereto, filed or to be filed, with the FDA seeking authorization and approval to manufacture, package, ship and sell a product as more fully defined in 21 CFR Section 314.5 et seq.


5


"Net Sales" means the [**]


Components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with GAAP.


In the event Sanofi-Synthelabo transfers Product to a Third Party in a bona fide arm's length transaction, for consideration, in whole or in part, other than cash or to a Third Party in other than a bona fide arm's length transaction, the Net Sales price for such Product shall be deemed to be the standard invoice price then being invoiced by Sanofi-Synthelabo in an arms length transaction with similar customers. In the event that Sanofi-Synthelabo includes one or more Product as part of a bundle of products, Sanofi-Synthelabo agrees not to offer or sell any such Product as a loss leader (i.e. sold at less than the invoice price at which any such Product is sold when not part of a bundle of products) in determining the price of the bundled products.


"Net Selling Price" means with respect to a given time period and for a given country, Net Sales with respect to such country divided by the number of Units sold in such country during such time period.


"New Product" means a product consisting of a combination of leuprolide acetate in the Atrigel(R) delivery system (other than the Product and substantially differentiable from the Product on the basis of l
-- End of Preview --
Home| About Us| FAQ| Subscription | Contact Us |

Privacy Policy   Terms of Service  34.204.43.11