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DEVELOPMENT AND MARKETING AGREEMENT

Marketing Agreement

DEVELOPMENT AND MARKETING AGREEMENT | Document Parties: SPECTRUM PHARMACEUTICALS INC | Par Pharmaceutical, Inc You are currently viewing:
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SPECTRUM PHARMACEUTICALS INC | Par Pharmaceutical, Inc

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Title: DEVELOPMENT AND MARKETING AGREEMENT
Governing Law: New York     Date: 5/1/2006
Industry: Biotechnology and Drugs    

DEVELOPMENT AND MARKETING AGREEMENT, Parties: spectrum pharmaceuticals inc , par pharmaceutical  inc
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EXHIBIT 10.1

Confidential treatment has been requested for portions of this Exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated by ***. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

DEVELOPMENT AND MARKETING AGREEMENT

      This Development and Marketing Agreement (this “Agreement”) is hereby entered into and effective as of February 22, 2006 (the “Effective Date”) by and between Spectrum Pharmaceuticals, Inc. (“Spectrum”), a Delaware corporation, with offices located at 157 Technology Drive, Irvine, California 92618 and Par Pharmaceutical, Inc. (“Par”), a Delaware corporation with offices located at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677. Spectrum and Par shall each be defined as a “Party” and together as the “Parties” under this Agreement.

      WHEREAS , Spectrum is engaged in the development of certain generic pharmaceutical products and desires Par to market, sell and distribute certain of Spectrum’s products in the Territory;

      WHEREAS , Par desires to market, sell and distribute certain of Spectrum’s products in the Territory;

      NOW THEREFORE , for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1. DEFINITIONS

     1.1. “ Act ” means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, and the rules, regulations and guidelines promulgated thereunder.

     1.2. “ Affiliate(s) ” means a Person that Controls, is Controlled by or is under common Control with a Party.

     1.3. “ ANDA ” means an Abbreviated New Drug Application pursuant to 21 U.S.C. 355(j) and 21 C.F.R. § 314.3.

     1.4. “ API ” means an active pharmaceutical ingredient used in the manufacture of a Product.

     1.5. “ Applicable Laws ” means all applicable laws, rules, regulations and guidelines that may apply to the development, manufacturing, exportation, importation, promotion, marketing, sale or distribution of the Products and/or the performance of a Party’s obligations under this Agreement, to the extent applicable and relevant, and including specifically, but without limitation, all cGMP or similar standards or guidelines of the FDA and including trade association guidelines, where applicable, as well as U.S. export control laws and the U.S. Foreign Corrupt Practices Act.

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     1.6. “ cGMP ” means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211.

     1.7. “ Commercial Launch ” means, on a product-by-product basis, the first sale of such Product by Par, or its Affiliate, to an unaffiliated Third Party after such Product has received all necessary Regulatory Approvals.

     1.8. “ Commercially Reasonable Efforts” means with respect to each Party, efforts and commitment of resources in accordance with such Party’s reasonable business, legal, medical, and scientific judgment that are consistent with the efforts and resources such Party would use for other products owned by it or to which it has exclusive rights, which are of similar market potential and at a similar stage in their life cycle, taking into account the competitiveness of the market place, the regulatory structure involved and other relevant factors.

     1.9. “ Committee ” shall have the meaning set forth in Section 4.1.

     1.10. “ Competing Product ” means any Drug Product, excluding the Products under this Agreement, which is a Therapeutic Equivalent of a Reference Listed Drug listed on Schedules 1.18, 1.19, 1.20 or 1.37.

     1.11. “ Confidential Information ” means with respect to a Party (as the “Disclosing Party”), all non-public information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, techniques and all non-public Intellectual Property Rights (defined below)), and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), which is disclosed by the Disclosing Party to the other Party (as the “Receiving Party”) and is acknowledged to be confidential at the time of such disclosure. Notwithstanding the foregoing, Confidential Information of a Disclosing Party shall not include information which the Receiving Party can establish by competent proof (a) to have been publicly known prior to disclosure of such information by the Disclosing Party to the Receiving Party, (b) to have become publicly known, without fault on the part of the Receiving Party, subsequent to disclosure of such information by the Disclosing Party to the Receiving Party, (c) to have been received by the Receiving Party free of an obligation of confidentiality from a source, other than the Disclosing Party, rightfully having possession of and the right to disclose such information free of an obligation of confidentiality, (d) to have been otherwise known by the Receiving Party prior to disclosure of such information by the Disclosing Party to the Receiving Party, or (e) to have been independently developed by employees or agents of the Receiving Party without the use of or access to Confidential Information of the Disclosing Party.

     1.12. “ Control ” including, with correlative meaning, the terms “Controlled by” or “under common Control with” means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person, whether by the ownership of at least fifty percent (50%) of the voting interest of such Person (it being

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understood that the direct or indirect ownership of a lesser percentage of such interest shall not necessarily preclude the existence of control), or by contract or otherwise.

     1.13. “ Drug Product ” means a drug product as defined in 21 C.F.R. § 314.3 for administration to human subjects.

     1.14. “ Development Costs and Expenses ” means the costs and expenses relating to all research and development for each Product for the Territory, including, without limitation, such costs and expenses related to materials (e.g., API), analytical testing (e.g., outside laboratory expenses), process development costs, pre-clinical and clinical costs, bioequivalence or bioavailability testing, exhibit batch and validation costs, processing and conversion costs of materials required for regulatory filings but excluding, costs and expenses associated with legal due diligence, litigation, and ANDA submissions and prosecutions.

     1.15. “ Direct Cost ” means (i) in the event a Party is manufacturing a Product, the direct costs actually incurred for the manufacturing, Labeling and Packaging of the Product including the cost of all API and excipient raw material ingredients, packaging components, and direct labor, including quality control and assurance testing that are a necessary part of manufacturing or (ii) in the event a Third Party is manufacturing a Product, the out-of-pocket expenses actually paid by such Party to a Third Party for Product. Direct Costs shall not include any Development Costs and Expenses or any allocations for overhead (except as set forth in the preceding sentence), depreciation, idle or excess capacity, or other indirect costs.

     1.16. “ Generic Products ” means collectively the Group A Generic Products, the Group B Generic Products and the Group C Generic Products.

     1.17. “ Governmental Authority ” means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization, commission, tribunal or organization or any regulatory, administrative or other agency, or any political or other subdivision, department or branch of any of the foregoing.

     1.18. “ Group A Generic Products ” means the Drug Products that are Therapeutically Equivalent to the Reference Listed Drugs listed on Schedule 1.18 attached hereto including all listed dosage strengths and Packaging forms thereof and for which Par is under no conflicting or prohibiting contractual obligations. *** The Parties acknowledge that Par is restricted from commercialization of the Cipro Tablet Products listed on Schedule 1.18 until March 11, 2006.

     1.19. “ Group B Generic Products ” means the Drug Products that are Therapeutically Equivalent to the Reference Listed Drugs listed on Schedule 1.19 attached hereto including all listed dosage strengths and Packaging forms thereof. The Parties acknowledge that Par is restricted from commercializing the Paraplatin Products listed on Schedule 1.19 until Spectrum’s agreement with Cura Pharmaceutical Company, Inc. (“Cura”) has been amended to become a non-exclusive agreement. Spectrum shall promptly notify Par when such agreement has been

 

 

 

 

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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amended. After Spectrum notifies Par, the Paraplatin Products will be considered a Group B Generic Product and notwithstanding anything in the Agreement to the contrary, Par shall have semi-exclusive rights to Carboplatin (i.e. only Cura and Par shall have the right to market Spectrum’s Paraplatin Products), and everywhere in this Agreement where it refers to exclusive rights to the Products, there shall only be semi-exclusive rights for the Paraplatin Products. ***

     1.20. “ Group C Generic Products ” means the Drug Products that are Therapeutically Equivalent to the Reference Listed Drugs listed on Schedule 1.20 attached hereto including all listed dosage strengths and Packaging forms thereof.

     1.21. “ FDA ” means the United States Food and Drug Administration or any successor agency thereto.

     1.22. “ First-to-File Opportunity ” means an opportunity to license or purchase the right to market, distribute, sell or have sold a Competing Product under a first filed ANDA pursuant 21 U.S.C. § 355(j)(2)(vii)(IV) against a Reference Listed Drug.

     1.23. “ Intellectual Property ” means without limitation all of the following: (i) patent applications, continuation applications, continuation in part applications, divisional applications, any foreign patent applications corresponding to any of the foregoing, and any patents that may grant or may have been granted on any of the foregoing, including without limitation reissues, re-examinations and extensions thereof; (ii) all know-how, trade secrets, inventions (whether patentable or otherwise), data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether patentable or not; (iii) copyrightable works, copyrights and applications, registrations and renewals; (iv) logos, trademarks, service marks, and all applications and registrations relating thereto; (v) other proprietary rights; and (vi) copies and tangible embodiments of any one or more of the foregoing.

     1.24. “ Label ,” “ Labeled ” or “ Labeling ” means all labels and other written, printed or graphic matter, (i) upon the Product or any container or wrapper utilized with the Product, or (ii) accompanying the Product, including without limitation, package inserts, which in either case may be subject to FDA review.

     1.25. “ Marketing Fee ” means the dollar amount equal to *** percent (***%) of Net Sales.

     1.26. “ Material Adverse Event ” means an event, change or occurrence that has or would reasonably likely cause a material adverse effect on the financial position, business, properties, operations or assets of Spectrum.

     1.27. “ NDA ” means a new drug application filed with the FDA pursuant to and under 21 U.S.C. § 355(b) of the Act, together with the FDA’s implementing rules and regulations.

     1.28. “ Net Profit ” means the Net Sales of each Product less ***

 

 

 

 

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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     1.29. “ Net Sales ” means the dollar amount determined by deducting from the gross amount invoiced for the Product sold by Par, or by an Affiliate of Par, or by a permitted sub-licensee, as the case may be, in the Territory the following to the extent they relate directly to the sale of the Products by Par: (i) all applicable sales credits accrued in accordance with accounting principles generally accepted in the United States, (ii) payments or rebates incurred pursuant to federal, state and local government assistance programs, whether in existence now or enacted at any time hereafter, (iii) costs for transit insurance, freight, handling or other transportation, (iv) customs duty, sales, use or excise taxes, and (v) the write-off of any bad debt. Sales credits accrued in accordance with accounting principles generally accepted in the United States include credits or discounts related to the following: (i) customer returns, returned goods allowances, billing and shipping errors, rejected goods and damaged goods, (ii) cash or terms discounts, (iii) customer rebate programs, (iv) chargebacks and administration fees or similar credits or payments granted to customers pursuant to contract or other purchases, (v) sales promotions, trade show discounts and stocking allowances, (vi) price adjustments, including those on customer inventories following price changes, and (vii) Product recall.

     1.30. “ Packaging ” means all primary containers, including bottles, cartons, shipping cases or any other like matter used in packaging or accompanying the Product.

     1.31. “ Person ” means an individual, corporation, partnership, limited liability company, firm, association, joint venture, estate, trust, governmental or administrative body or agency, or any other entity.

     1.32. “ Proceedings ” means, without limitation, governmental, judicial, administrative or adversarial proceedings (public or private), litigation, suits, arbitration, disputes, claims, causes of action or investigations.

     1.33. “ Products ” means both Generic Products and the Sumatriptan Products.

     1.34. “ Product Specifications ” means the specification for each Product as approved in the Regulatory Approval for such Product, including (as applicable) statements of pharmaceutical manufacturing, labeling, filling, packaging, storage and quality control procedures, and Labeling and Packaging specifications (as such may be revised from time to time in accordance with Applicable Law) together with any additional specifications that may be agreed to between the Parties.

     1.35. “ Reference Listed Drug ” shall have the meaning set forth at 21 C.F.R § 314.3.

     1.36. “ Regulatory Approvals ” means, with respect to each Product, any approvals, product and/or establishment licenses, registrations, permits or authorizations, including without limitation approvals under ANDAs which are necessary for the commercial manufacture, use, storage, importation, transport, promotion, pricing, distribution or sale of each Product in the Territory or other applicable locations.

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     1.37. “ Sumatriptan Products ” means all dosage and/or Packaging forms of the Drug Products listed on Schedule 1.37 that are Therapeutically Equivalent to the Reference Listed Drug Imitrex (sumatriptan) ***

     1.38. “ Territory ” means the United States, its territories, possessions, protectorates and the Commonwealth of Puerto Rico.

     1.39. “ Therapeutic Equivalent ” including, with correlative meaning, the term “Therapeutically Equivalent” shall have the meaning given to it by the FDA in the edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations” which was current as of the Effective Date (the “Orange Book”).

     1.40. “Third Party” or “Third Parties” shall mean any Person or entity other than a Party or its Affiliates

     1.41. “ Transfer Price ” means the dollar amount equal to the Direct Cost for each Product.

ARTICLE 2. DEVELOPMENT

     2.1. General Development Obligations . Spectrum shall use Commercially Reasonable Efforts to develop each Product, for all applicable dosage strengths and Packaging forms listed on Schedules 1.18, 1.19, 1.20 and 1.37. For future products, it is the intent of both Parties for Spectrum to develop all approved dosage strengths and Packaging forms, however, the Committee shall decide which dosage strengths and Packaging forms will be developed. Spectrum’s development responsibilities shall include, without limitation, the following: !

2.1.1. Spectrum shall develop a stable final dosage form of each Product, which does not infringe any Third Party Intellectual Property that shall be Therapeutically Equivalent to the corresponding Reference Listed Drug. ***

2.1.2. Spectrum shall manufacture, or ensure that a Third Party manufactures, all supplies of the Products required for Regulatory Approval in facilities that meet the Applicable Laws.

2.1.3. Spectrum shall be responsible for, and maintain, materials, facilities and personnel reasonably necessary to fulfill its obligations under this Agreement.

2.1.4. Spectrum shall keep Par informed of the progress of the development of the Products and shall cooperate with Par and its legal counsel in assessing and avoiding infringement of Third Party Intellectual Property ***, including, but not limited to, providing Par and its legal

 

 

 

 

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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counsel with proposed and final formulations, results of all testing and analytical studies, API processing and synthesis information, manufacturing processes and access to Spectrum’s technical personnel involved in the development of a Product.

2.1.5. Spectrum shall conduct all reasonable testing and analytical studies required by the FDA to support an ANDA for each Product as applicable.

     2.2. Development Compliance . Spectrum shall comply with, and shall require compliance by its Third Party contractors with, all Applicable Laws in the conduct of all activities associated with the development and manufacture of the Products including all associated analytical methods and cGMP requirements.

     2.3. Development Costs and Expenses . Spectrum shall be responsible for all Development Costs and Expenses for each Product, including any bioequivalence or bioavailability studies that are needed for the filing and approval of an ANDA for a Product. In the event Spectrum requests that Par reasonably assist in the development of any Product, Spectrum shall reimburse Par for all of its reasonable costs and expenses associated with such assistance that are approved in writing in advance by Spectrum.

     2.4. Future Products. The Parties desire that their collaboration with respect to the development and commercialization of generic pharmaceutical products be extended to additional brand name products and generic products in addition to the Products. In view of that desire, the Parties shall work together to develop additional products over a mutually acceptable period of time.

2.4.1. From time to time during the term of this Agreement either Party may nominate additional product for collaboration through the Committee, which the other Party shall duly consider.

2.4.2. The Parties agree to either incorporate any additional products into this Agreement through amendment or to negotiate in good faith a new agreement. With respect to additional generic products, such an agreement shall be on substantially similar terms and with substantially similar financial terms as those relating to the Generic Products and/or Sumatriptan Products, as applicable, set forth in this Agreement, with the understanding that such terms and conditions may be different from those described herein.

2.4.3. Any information or materials shared by either Party during the course of any discussions or negotiations relating to the collaboration on any additional products shall be deemed Confidential Information and subject to Article 10 of this Agreement.

ARTICLE 3. REGULATORY

     3.1. ANDA Ownership . The ANDA for each Product shall be owned exclusively by

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Spectrum. Spectrum shall maintain all Regulatory Approvals during the term of this Agreement.

     3.2. ANDA Prosecution.

3.2.1. The Parties acknowledge that Spectrum has filed a number of ANDAs for the Products prior to the Effective Date and with respect to such Products Spectrum shall diligently continue to pursue Regulatory Approval of such Product.

3.2.2. With respect to the Products not covered under Section 3.2.1, Spectrum shall use Commercially Reasonable Efforts to file ANDAs for such Products as soon as possible and shall thereafter continue to diligently pursue Regulatory Approval.

3.2.3. Par shall be provided with the opportunity to review and comment on all future material submissions to the FDA, including any ANDAs, relating to the Products.

3.2.4. Spectrum will provide copies of all material information related to the Products in its possession or control and all submissions made to the FDA related to the Products, including any accompanying material data, to Par upon Par’s request. Notwithstanding the foregoing, regarding Third Party information, Spectrum shall use Commercially Reasonable Efforts to obtain consent from such Third Parties to provide such information to Par. For future agreements with Third Parties regarding Products, Spectrum shall use Commercially Reasonable Efforts to negotiate a three-way CDA with Spectrum, Par and the Third Party to allow Spectrum to share the Third Party’s confidential information with Par.

     3.3. Expenses . Spectrum shall bear all costs and expenses associated with gaining and maintaining Regulatory Approval for each Product.

     3.4. Progress Updates . Spectrum shall keep Par informed of the progress of the prosecution of each ANDA, including providing good faith projections of the approximate time at which approval of the ANDA may be expected and providing notice of any negative communications from the FDA which could affect approval timing or otherwise affect the supply of Product.

ARTICLE 4. COLLABORATION COMMITTEE

     4.1. Establishment of the Committee . The Parties each hereby agree to work together in good faith in the collaboration under this Agreement and to keep each other reasonably informed of its activities under this Agreement. Additionally, and in support of the foregoing, promptly after the Effective Date, the Parties will form a committee comprised of six (6) people in total to facilitate communication between the Parties and to administer the collaboration (the “Committee”). Each Party shall have equal representation in the Committee. Each Party shall have the right from time to time to substitute new members, on a permanent or temporary basis, for any of its previously designated members of the Committee. Each Party

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shall bear its own costs associated with participation in the Committee.

     4.2. Purpose and Responsibilities of the Collaboration Committee . The Committee shall generally oversee the development and the commercialization of the Products and facilitate communication between the Parties, including as follows:

4.2.1. The Committee shall coordinate the exchange of information, technology and know-how as applicable to the collaboration;

4.2.2. The Committee shall establish approximate timelines for the development of the Products including timing of bioequivalence or bioavailability studies and the filing of the ANDAs;

4.2.3. The Committee shall establish approximate timelines associated with the commercialization of the Products including the timing of supply and manufacturing commitments, the timing of the Commercial Launch, and marketing of the Products such as achieving certain sales targets;

4.2.4. The Committee shall oversee the development of each formulation and the associated legal assessments including those of risks associated with Third Party Intellectual Property;

4.2.5. The Committee shall facilitate communication regarding, and resolution of, any disputes between the Parties;

4.2.6. The Committee shall also address such other matters as are referred to the Committee from time to time by mutual agreement of the Parties;

4.2.7. The Committee shall discuss and the Parties shall mutually agree to add new products as set forth in Section 2.4;

4.2.8. The Committee shall discuss and the Parties shall mutually agree to add new dosage strengths and Packaging forms for the Products to the appropriate Schedule; and

4.2.9. The Committee shall discuss pricing of the Products, and in addition, Spectrum may request pricing information from a representative of Par on the Committee at any time.

     4.3. Decision-Making; Limitations on Authority . Decisions of the Committee shall be made by unanimous agreement. In the event that unanimity is not achieved within the Committee, the matter will be referred to Par’s and Spectrum’s CEOs, who shall promptly meet and endeavor in good faith to resolve such matter in a timely manner. The Committee shall not have any authority to impose financial, cost or other obligations on either Party in excess of those expressly set forth in this Agreement, unless expressly consented to in writing by such Party.

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     4.4. Collaboration Committee Meetings . During the term of this Agreement, the Committee shall meet at least twice each calendar year or at such other frequency as the Committee determines. The Parties shall meet on a date and at a time and location determined by the Committee; the Parties anticipate alternating meetings between the Party’s respective sites. Upon written notice by either Party to the other that a meeting is required or requested, a meeting will be held within thirty (30) calendar days of such notice on a date and time and at a location to be agreed upon by the Parties, or sooner if warranted by the circumstances. Notice requesting such a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the Committee may be held in person at a location to be agreed to by the Parties, or by videoconference or teleconference. A reasonable number of additional representatives of either Party including outside consultants and legal counsel, subject to the other Party’s reasonable consent, may attend meetings of the Committee in a non-voting capacity. At least one week prior to any meeting of the Committee, each Party shall provide the other with a proposed agenda of the matters to be discussed at such meeting. A Committee Chairperson shall be selected for a one-year term and shall alternate between designees of the Parties, commencing with a designee of Spectrum. Within thirty (30) days after each meeting, the Committee Chairperson will provide the Parties with a written report describing, in reasonable detail, a summary of the meeting and a summary of the results and progress to date, the issues requiring resolution and the agreed resolution of previously reported issues.

ARTICLE 5. COMMERCIALIZATION

     5.1. License Grant . Spectrum hereby grants to Par an exclusive (even as to Spectrum) royalty-free, irrevocable license under its rights in and to the Regulatory Approvals and under its Intellectual Property rights associated with the Products to market, promote, distribute, sell and have sold the Products in the Territory. The foregoing license shall include the right for Par to grant sublicenses and appoint sub-contractors to market, distribute and sell the Products within the Territory on Par’s behalf.

     5.2. Promotion, Marketing, Sales and Distribution Obligations .

5.2.1. Par, at its sole expense, shall use Commercially Reasonable Efforts to launch, market, promote, distribute and sell the Products in the Territory consistent with Par’s efforts in regards of the other generic products that it distributes, as applicable. Ultimate responsibility and decision-making control with regard to marketing and pricing of the Products shall belong solely to Par. Nothing in this Agreement shall require Par to sell any Product at a loss.

5.2.2. ***

 

 

 

 

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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5.2.3. The label for the Products shall be a Par label in accordance with Par’s customary practices and with the Applicable Law. However, Spectrum’s name shall be included on the label in accordance with the Applicable Law.

     5.3. Launch Timing . Subject to Par’s evaluation of any legal issues, regulatory issues, and any supply problems not resulting from a breach of Par’s supply obligations under this Agreement (a “Launch Problem”), the Commercial Launch of each Product shall take place no later than *** after receipt of the Regulatory Approvals necessary to sell, market and distribute such Product. The above notwithstanding, with regards to Products that have received Regulatory Approval prior to the Effective Date, or receive Regulatory Approval within one hundred and twenty (120) days of the Effective Date, the Parties agree to work together to set an appropriate time for the Commercial Launch of such Products. Nothing in this Section shall be construed as requir


 
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