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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: NPS PHARMACEUTICALS INC | NPS ALLELIX CORP You are currently viewing:
This License Agreement involves

NPS PHARMACEUTICALS INC | NPS ALLELIX CORP

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Title: LICENSE AGREEMENT
Date: 11/9/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: nps pharmaceuticals inc , nps allelix corp
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Exhibit 10.1

NOTE: C ERTAIN C ONFIDENTIAL I NFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT AND REPLACED BY “[*]”. A COMPLETE COPY OF THIS DOCUMENT INCLUDING THE C ONFIDENTIAL I NFORMATION HAS BEEN FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION .

L ICENSE A GREEMENT

T HIS L ICENSE A GREEMENT (the “ Agreement ”) is made and entered into as of July 2, 2007 (the “ Effective Date ”), by and between NPS ALLELIX CORP. (“ NPS ”), with a business address of MaRS Centre, 101 College Street, South Tower, Suite 800, Toronto, ON MSG 1L8 Canada, and Nycomed Danmark ApS (“ Nycomed ”), company registration number CVR 16406899, located at Langebjerg 1, 4000 Roskilde, Denmark. NPS and Nycomed are referred to in this Agreement individually as a “ Party ” and collectively as “ Parties .”

WHEREAS, NPS and Nycomed on April 20, 2004 entered into that certain Distribution and License Agreement (as amended on July 1, 2004 and on June 5, 2007, “Distribution Agreement” ) and on February 24, 2005 entered into that certain Supply Agreement (as amended on July 29, 2005, “Supply Agreement” );

WHEREAS , the Parties desire to enter into this Agreement to provide for the assumption by Nycomed of obligations relating to the supply of Product and the release of NPS from such supply obligations, in exchange for Nycomed receiving the right to market the Product in additional countries as set forth herein; and

WHEREAS , the Parties desire to have performance under the Distribution Agreement excused during the term of this Agreement as set forth herein.

NOW THEREFORE , in consideration of the mutual covenants and conditions herein contained, and intending to be legally bound hereby, the parties mutually agree as follows:

 

1. DEFINITIONS

1.1 “Actual True Cost of Goods” means with respect to the Product, the costs actually incurred by NPS, in accordance with generally accepted accounting principles, for supply and manufacture of Drug Substance, Product or Devices, as the case may be, including costs for testing and release of such items.

1.2 “Affiliate” means a corporation or other business entity which, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with a Party. For purposes of this definition only, “control” and, with corresponding meanings, the terms “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting

 

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securities or other ownership interest of a legal entity; provided , however , that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.

1.3 “Approvals” means any approvals of any national or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, storage, importation, export, transport, distribution or sale of a Product or Device except for the Marketing Authorization.

1.4 “Control” or “Controlled by” means, with respect to a Party, any Patent, Know-How, other intellectual property right, or Marketing Authorization, (a) that such Party owns or has a license to use such Patent, Know-How, intellectual property right or Marketing Authorization, and (b) has the ability to grant the other Party access, a license or a sublicense (as applicable) or right to use such Patent, Know-How, or intellectual property right, or the right to reference such Marketing Authorization during the Term without violating the rights of any Third Party and without obligation to make any payments to a Third Party as a result of such grant of access, license or sublicense, or right of reference, or the exercise thereof by the other Party. For purposes of information that a Party is obligated to transfer under this Agreement, “ Control ” or “ Controlled by ” means such information that is reasonably available to such Party.

1.5 “Device” means the drug delivery device described in Schedule 1.5 hereto and any future Improvements hereof.

1.6Drug Master File ” or “ DMF ” shall mean a submission to the FDA or other regulatory agency used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs, as more particularly described in United States Code of Federal Regulations, 21 CFR 314-420.

1.7 “Drug Substance” means shall mean the parathyroid hormone drug substance to be used for the Product.

1.8 “EU” means the member states from time to time of the European Union.

1.9 “Future Partner” means a Third Party to whom NPS grants rights to commercialize or distribute the Product in the US.

1.10 “Improvement” means any invention, discovery, derivative or Know-How, whether or not patentable, relating to the Product, the Device or Drug Substance (including in other formulations and indications). Any general patent or patent application which relates both to the Product, Device or Drug Substance as well as to other active substances shall be included in the definition of Improvement.

1.11 “Know-How” means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, Technical Information, databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data relating to the Product, Device or Drug Substance.

 

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1.12 “Licensed Technology” means the NPS Know-How, NPS Patents, and any Improvements relating to the Product, Device or Drug Substance.

1.13 “MAA” means a Marketing Authorization application submitted to the appropriate regulatory body in a country of the Territory for the purposes of obtaining Approval for the marketing of a pharmaceutical product in such country.

1.14 “Marketing Authorization” means any approvals (including, but not limited to, price and reimbursement approvals) and any master files, DMFs, establishment licenses, registrations or authorizations (including the approval of an MAA) issued under Directive 2001/83/EC or local legislation deriving thereof (as amended by Directive 2004/27) or local legislation deriving thereof, Council Regulation 2309/93 and any amendments or replacements hereof or any national equivalents (whether inside or outside the Territory) in relation to the Product and any CE Marking or approval by local authorities of the Device.

1.15 “Master Cell Bank” means NPS’ master cell bank containing the host cell (with the plasmid incorporated therein) for fermentation of the recombinant parathyroid hormone. The Master Cell Bank is used to generate the Working Cell Bank.

1.16 “Net Sales” means the gross amount invoiced by Nycomed or its Affiliates or sublicensees for sale or other commercial disposition of a Product to a Third Party in the Original Territory, as described in Section 7.3, less the following deductions:

(a) Discounts and allowances allowed and taken for returns or rejections (provided such amounts have been formally designated as such in accordance with the internal accounting procedures, consistently applied, of Nycomed and its Affiliates), and wholesaler charge backs allowed and taken in amounts normal and customary in the trade;

(b) Import, export, excise, sales or use taxes, value added taxes, and other taxes, tariffs or duties levied, absorbed or directly imposed and properly allocable to particular sales of Products to the extent such items are included in the gross amount invoiced (in any event excluding taxes on the income of Nycomed and its Affiliates);

(c) Freight, postage, shipping, insurance, and packaging costs and other outbound transportation charges prepaid or allowed to the extent included as part of the invoiced amount;

(d) Amounts allowed or credited for retroactive price reductions or rebates;

(e) The amounts of trade and cash discounts actually allowed on account of the purchase of Products;

(f) Allowances, adjustments, reimbursements, discounts and rebates made with respect to sales paid for by Third Parties, including, but not limited to, rebates given to health care organizations or other Third Parties who bought or paid for a Product; and

 

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(g) Any amounts actually written off or specifically identified as uncollectible, in accordance with consistently applied accounting policies of Nycomed and except to the extent Nycomed recovers payment of any such written off amounts; provided however, that no such deduction shall be made for the Actual True Cost of Goods of such Product.

(h) Notwithstanding the foregoing, if: (i) a Product is sold together with other goods, whether with a separate price for such Product (unless such separate price is the same as the price for such Product when not sold together with other goods) or without a separate price for such Product, (ii) the consideration exchanged for a Product includes any non-cash consideration, or (iii) a Product is transferred for purposes of resale, in any manner other than as an invoiced sale, then, in each case the Net Sales applicable to the quantity of such Product included in any such transaction will be deemed to be the average Net Sales for such quantity of such Product for all transactions of such Product (other than those described in the preceding Sections (i)-(iii), inclusive) made in the relevant country during the last full calendar quarter prior to such transaction (or, if the Product was not commercially available during the last full calendar quarter preceding such transaction, during the current quarter).

(i) In the event that Products are sold or otherwise disposed of to a Third Party other than on arm’s length terms and are subsequently sold or otherwise disposed of by such Third Party on arm’s length terms, then Net Sales will be calculated based upon the first such arm’s length sale or disposition. “Net Sales” excludes (a) the transfer of reasonable and customary quantities of free samples of Product to physicians for professional use, other than for subsequent resale, (b) the transfer of Product as clinical trial materials, other than for subsequent resale, and (c) the transfer of Product to any regulatory agency in a country in the Territory for use by such agency in connection with securing Marketing Authorization for such Product in such country.

(j) In the event that Product is sold through sublicensees, distributors etc. appointed by Nycomed any costs, margins etc. payable by Nycomed to any such sublicensee, distributor etc. shall be borne solely and entirely by Nycomed and no such amount(s) shall be deducted when determining Net sales pursuant to this definition.

1.17New Territory ” means all countries of the Territory which are not the Original Territory.

1.18 “NPS Know-How” means (a) any non-public or confidential sections of any MAA relating to any Product, and (b) any other non-public or confidential Know-How Controlled by NPS during the Term that is necessary or useful for the performance of pre-clinical or clinical development, for the filing of Marketing Authorizations in the Territory, or the commercialization, marketing or manufacture of a Product.

1.19 “NPS Patents” means the Patents listed in Schedule 1.19, as well as any Patents that NPS and its Affiliates own, have under license, have a right to acquire or Control, that are necessary or useful for, or otherwise, related to the exercise of the licenses granted in Section 2, such Patents to be added to Schedule 1.19 by NPS from time-to-time, with Nycomed’s approval.

 

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1.20 “Original Territory” means all the countries of the EU, European countries outside EU, the Commonwealth of Independent States (formerly the USSR) and Turkey.

1.21 “Patent” means patents, letters patent, applications for patents, provisional applications for patents, and any patents issuing therefrom (including any divisions, continuations, continued prosecution applications and continuations-in-part thereof), reexamination certificates, reissue patents, patent extensions, patent term restorations, supplementary protection certificates issued under directive Council Regulation 1768/92 and any amendments and replacements hereof and any equivalents, substitutions, confirmations, registrations, revalidations, additions, continuations in part and divisions thereof.

1.22 “Product” means any pharmaceutical formulation dosing and administration form of the Drug Substance recombinant human parathyroid hormone 1-84, as currently set out in EMEA/H/C/659 as well as any Improvements thereto.

1.23 “Product Trademarks” means any trademarks, trade dress, logos, slogans, and designs, whether or not registered in the Territory, used to identify or promote a Product in the Territory including the trademarks listed in Schedule 2.2.

1.24 “Technical Information” means all information in physical form be it written, electromagnetic or photographic in relation to the Product, Drug Substance or Device including, without limiting the generality of the foregoing, results of pre-clinical studies and clinical trials, formulae, raw-data from product development, data, drawings and designs, toxicological, pharmacological, analytical and quality control data and testing data Controlled by NPS or Nycomed or their Affiliates and of which such entity is free to dispose, which is necessary or useful to the manufacture, development or other exploitation of Drug Substance, Products and Devices in accordance with this Agreement. Technical Information as defined in this Agreement shall be considered “Know-how” and include information relating to Master Cell Bank and Working Cell Bank as well as all research and development related information on the pharmaceutical technical aspects concerning the formulation and manufacturing of the Product and the Drug Substance.

1.25 “Term” means the period from Effective Date and until the earlier of termination or expiry as set out in Section 16.

1.26 “Territory” means all the countries of the world, except for US, Japan and Israel.

1.27 “Third Party” means any individual or entity other than NPS, Nycomed and their respective Affiliates including, but not limited to any national or local governments, hospitals, drug wholesalers, pharmacies and other third party customers.

1.28 “Working Cell Bank” means NPS’ working cell banks containing the host cell (with the plasmid incorporated therein) for fermentation of the recombinant parathyroid hormone. The Working Cell Bank is generated from the Master Cell Bank.

 

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2. LICENSE GRANT

2.1 Licensed Technology. NPS hereby grants to Nycomed the exclusive right and license, with a right to sublicense, under the Licensed Technology to market, use, import, export, distribute and sell the Product and Devices in the Territory in accordance with the terms of this Agreement; provided, however, that with respect to any sublicense relating to the Original Territory, such sublicense shall require NPS’ prior written consent, such consent not to be unreasonably withheld.

2.2 Trademarks. NPS hereby sells, assigns and transfers to Nycomed the entire right, title and interest in and to the PREOTACT trademarks in the Territory as identified on Schedule 2.2, together with the trademark registrations and trademark applications identified on Schedule 2.2 and any accompanying goodwill pertaining thereto, together with all claims, demands and causes of action for the past infringement of any or all of the trademarks or for unfair competition in business in connection therewith, the same to be held and enjoyed by Nycomed, its successors, assigns or other legal representatives as fully and entirely as the same would or could have been held and enjoyed by NPS had this assignment not been made. NPS hereby grants to Nycomed an exclusive and royalty free license to use the Product Trademarks other than the PREOTACT trademarks in the Territory under the terms of this Agreement in connection with marketing, sale, use, import and distribution, and/or sublicensing with NPS’ prior consent, which shall not be unreasonably withheld, of the Product and Device. Product Trademarks shall be solely for display, advertising, labeling and packaging purposes in connection with marketing, selling and distributing Product and Devices in accordance with this Agreement. Nycomed shall not at any time do or permit any act to be done which may in any way impair the rights of NPS in Product Trademarks.

2.3 Limitation Relating to Canada and Mexico. Notwithstanding Sections 2.1 and 2.2, the license granted hereunder with respect to Canada and Mexico shall be limited as set out in Section 8.

2.4 Manufacture. NPS hereby grants to Nycomed the non-exclusive royalty-free right under the Licensed Technology to develop, have developed, manufacture and have manufactured Product, Drug Substance and the Devices for its own use, or use of its sublicensees or for supply of Products, Drug Substance or Devices to NPS and any Future Partner in the Territory.

2.5 Technical Information. NPS further grants to Nycomed the exclusive royalty-free right and license, with a right to sublicense (in respect of rights relating to the Original Territory with NPS’ prior written consent which shall not be unreasonably withheld), to use the Technical Information of NPS to develop Product, Drug Substance or Device and to submit for approval for or amendment of Marketing Authorization for the Product. The license granted pursuant to this Section 2.5 does not impose on NPS an obligation to actually engage in or support any application for a Marketing Authorization in the Territory.

2.6 Nycomed Grant to NPS. Nycomed grants to NPS the exclusive royalty-free right and license, with a right to sublicense or subcontract distribution to a partner with Nycomed’s prior written consent on terms to be reasonably negotiated, to use the Technical Information of Nycomed to development Product, Drug Substance or Device and to submit for approval for or amendment of Marketing Authorization for the Product. The license granted pursuant to this Section 2.6 does not impose on Nycomed an obligation to actively engage in or support any application for a Marketing Authorization outside the Territory. In addition, Nycomed hereby grants to NPS the exclusive right and license, with a right to sublicense or

 

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subcontract distribution to a partner with Nycomed’s prior written consent on terms to be reasonably negotiated, under Nycomed’s Improvements to develop, make, have made, use, import, sell and have sold the Product and Devices outside the Territory. The licenses granted under this Section 2.6 shall not limit Nycomed’s rights under Section 2.7 to enter into negotiations with, or grant rights to, a Future Partner.

2.7 Improvements. Nycomed undertakes upon request by a Future Partner to discuss in good faith exploitation of Improvements outside the Territory with any Future Partner. NPS undertakes to use reasonable efforts to insert in any agreement with a Future Partner an equivalent obligation on a Future Partner to discuss in good faith exploitation of Improvements conceived by the Future Partner inside the Territory.

2.8 Clinical Study Data. NPS hereby grants to Nycomed the exclusive rights in the Territory, to the extent of NPS’ rights, to exploit all data emerging from the clinical study entitled “The Effects of PTH on the Skeleton in Hypoparathyroidism.”

2.9 Right of Negotiation. NPS grants to Nycomed the right of negotiation with respect to any of NPS’ pipeline products and or new products, which NPS is offering in a competitive process for license or sale to non-Affiliates in the Territory. Nycomed shall be provided with the same data, documentation, and other information simultaneously as such information is being submitted to any Third Party relating to the right of negotiation in the previous sentence.

2.10 Territorial Restriction. NPS shall ensure, to the extent permitted by applicable law, that its other licensees who distribute the Product outside the Territory will not actively sell the Product in the Territory. Nycomed shall ensure, to the extent permitted by applicable law, that it and its licensees who distribute the Product in the Territory will not actively sell the Product outside of the Territory.

2.11 Distribution Agreement. On the Effective Date, the Parties’ performance and all obligations under the Distribution Agreement shall be excused in all respects until midnight on September 1, 2007, at which time such performance and obligations shall be reinstated in full as of such time (including, without limitation, that NPS shall supply Product at the prices set out in the relevant provisions of the Distribution Agreement and the Supply Agreement); provided, however, that (i) the provisions of Section 19.7.2 of the Distribution Agreement shall not be reinstated but shall be immediately terminated and deemed null and void in all respects; and (ii) upon the earlier delivery of the Release Certificate as set forth in Section 6.8, the Distribution Agreement shall be immediately terminated and deemed null and void in all respects upon the date of such delivery. Notwithstanding the foregoing, until the Supply Agreement is terminated as set forth in Section 6.8 the sections and definitions contained in the Distribution Agreement incorporated by reference into the Supply Agreement shall continue to be so incorporated in the Supply Agreement. In the event that the Release Certificate is not delivered as set forth in Section 6.8, subject to Section 16.8, this Agreement shall be immediately terminated and deemed null and void in all respects (provided, however, that any amounts due and payable hereunder but not paid as of such termination date shall be due and payable in accordance with the terms of this Agreement). In the event that the Release Certificate is not delivered as set forth in Section 6.8, except as expressly contemplated in the provisions specified in Section 16.8, each of the Parties shall use reasonable efforts to put the other Party in the position it was in before entering into this Agreement, including, without limitation, the return of the information of relevant Third Parties, the return of Technical Information and the return of any registered rights relating exclusively to the New Territory (except for Brazil, which rights shall not be returned).

 

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3. DEVELOPMENT

3.1 Development. Nycomed shall have the right to develop the Product, Drug Substance and the Device including the development hereof for new administration forms and indications. Nycomed shall inform NPS or a Future Partner designated by NPS about its ongoing development projects on a quarterly basis. NPS or such Future Partner shall treat any such information as confidential in accordance with Section 13. Subject to Section 2.7, Nycomed shall have exclusive ownership to all Improvements conceived solely by Nycomed.

 

4. COMMERCIALIZATION

4.1 Commercialization . Nycomed will be solely responsible for the commercialization of the Product in the Territory at Nycomed’s expense. Nycomed shall have the right to commercialize through sublicensees. Nycomed shall launch, market and sell the Product in the countries of the Territory in which Nycomed at its sole discretion finds the marketing financially feasible. If Nycomed determines that launching the Product in a country in the Original Territory, Canada or Mexico would not be commercially viable or would substantially limit the commercial potential of the Product in other countries of the Territory, then Nycomed will provide NPS with written notice of such determination and with copies of or access to all evidence considered by Nycomed in making such determination. Such evidence will be updated annually on request by NPS for as long as Nycomed does not launch Product in any country of the Original Territory, Canada or Mexico. In relation to the New Territory, other than Canada or Mexico, Nycomed shall have no reporting obligations.

4.2 Marketing Plan. Nycomed will commercialize the Product in the Territory pursuant to an annually updated marketing plan (“Marketing Plan”). Nycomed will prepare the Marketing Plan according to Nycomed’s marketing planning process and will include at a minimum in each Marketing Plan, medical education and communication, publications, congress and symposia, patient education, life cycle management, brand strategy, pan-EU brand positioning, key messages, Phase IV program, public relations, sales and distribution strategies. Each Marketing Plan will identify commercial milestones and describe the Product’s positioning and specify the target physician and patient populations and distribution channels to which Nycomed will devote its promotional efforts, the personnel and other resources by or on behalf of Nycomed as well as market and sales forecasts for the Product in the Territory.

4.3 Review and Comment on Marketing Plan . Nycomed will submit the final draft of the initial and updated Marketing Plan to NPS for review and comment. NPS will have twenty (20) business days to provide comments on such draft to Nycomed, and Nycomed will reasonably consider and address such comments prior to finalization and implementation of such plan. NPS shall review the Marketing Plan with a view to optimize the value of the Product and maintain brand consistency for the Product in the Territory that is not in conflict with NPS’ global commercialization strategy.

 

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4.4 Launch Diligence Obligations . Subject to Section 4.1, Nycomed undertakes to launch the Product through its own sales and marketing organization in Germany, UK, France, Italy, Spain, Greece, Austria, Switzerland, Belgium, Netherlands, Sweden, Norway, Denmark, Finland, Estonia, Latvia, Lithuania, Poland and the Commonwealth of Independent States (formerly the USSR) and to maintain the necessary personnel to perform sales and marketing activities towards relevant target groups of hospital and office based specialists. Furthermore, Nycomed will launch the Product in each country in the Original Territory as soon as reasonably possible after receipt of Marketing Authorization, pricing and reimbursement approval, for the Product and Device in such country, but in no event later than four (4) months after such receipt; provided, however, that such 4-month period will be tolled during such time as commercial supply of such Product is not available to Nycomed other than as a result of any act or omission by Nycomed. Schedule 4.4 contains a description of Nycomed’s initial sales and marketing personnel commitment to the Original Territory during the first five years from launch. Such allocation shall be fully in place twelve (12) months from launch and shall not be decreased by more than thirty-five percent (35%) in a country or more than twenty-five percent (25%) in the aggregate in the Original Territory without prior consultation and approval by NPS. Should Nycomed, to an unreasonable extent, delay or postpone the launch of the Product in any of the markets as set forth in this Section 4.4 for reasons within Nycomed’s or Nycomed’s sublicensees control (or any other markets in the Original Territory), NPS or its sublicensee shall be entitled but not obliged to “march-in” to ensure the launch of the Product in any such country, and Nycomed’s rights with respect to any such countries may be terminated.

4.5 General Diligence Obligations . Nycomed will use commercially reasonable efforts to perform the activities set forth under each Marketing Plan. Nycomed will promote, market, sell and distribute the Product in the Territory by applying efforts and resources as reasonably required to capture the commercial potential of the Product throughout the Original Territory and at least equal to the efforts and resources normally used by a similarly situated pharmaceutical company for a product owned by it which has a similar market potential and is at a similar stage in its product life cycle as the Product. All efforts of Nycomed’s Affiliates, sublicensees or distributors will be considered efforts of Nycomed for the purpose of determining Nycomed’s compliance with its obligations under this Section 4.5.

4.6 Nycomed Diligence Concerning Shipment of Product Outside the Territory. Nycomed may not deliver or tender (or cause to be delivered or tendered) any Product outside of the Territory. If Nycomed receives any order from a prospective purchaser located outside the Territory, Nycomed shall immediately refer that order to NPS. Nycomed shall not accept any such orders. Notwithstanding anything in this Section 4.6 to the contrary, if Nycomed receives an unsolicited order for Product from a prospective purchaser located outside the Territory, and such purchaser is committed to resell the Product back into the New Territory and not the Original Territory (as evidenced by a written agreement by such purchaser), then Nycomed may accept such order; provided, however, that if any such Product is sold back into the Original Territory and Nycomed knew or had reason to know such fact when selling such Product to such purchaser, then such sale shall be included in Net Sales for purposes of Section 7.5. In addition, with respect to sales invoiced in the New Territory but that were re-sold or imported for resale into the Original Territory, see Section 7.3.

4.7 Right of Reference . Subject to the terms and conditions set forth in this Agreement, (i) NPS hereby grants to Nycomed a fully paid, exclusive right and license to reference any Marketing Authorizations Controlled by NPS for Product outside the Territory for

 

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the purpose of obtaining Marketing Authorization of the Product in one or more countries in the Territory and (ii) Nycomed hereby grants to NPS and its sublicensees a fully paid, exclusive right and license to reference any Marketing Authorizations Controlled by Nycomed for Product inside the Territory for the purpose of obtaining Marketing Authorization of the Product in one or more countries outside the Territory. The license granted pursuant to this Section 4.7 does not impose on any of the Parties an obligation to actively engage in or support any application for a Marketing Authorization in the territory of that other Party.

 

5. MARKETING AUTHORIZATION

5.1 Filing of Marketing Authorizations . Subject to Section 4.4, Nycomed shall have the right to, and shall at its sole discretion file the MAAs in order to obtain Marketing Authorizations or to have amended the existing MAA in any country of the Territory.

5.2 Ownership and Maintenance of Marketing Authorizations. Nycomed shall be the Marketing Authorization holder and owner in respect of all Products in each part of the Territory and shall assume all responsibilities towards the regulatory authorities. Nycomed shall maintain the Marketing Authorizations at its costs in the Territory for the Term. NPS will, throughout the Term, at its own costs, provide technical and scientific support to the extent such support is reasonably possible to NPS, taking into consideration its operations at the time of Nycomed’s request or to the extent the request relates to data available to NPS but not to Nycomed.

5.3 Meetings and Correspondence. The provisions of this Section shall not apply to adverse events reporting, which shall be governed by Section 5.4. To the extent either Party receives any written or oral communications relating to a Product from any regulatory authority in the Territory, such Party will promptly inform the other Party and the Future Partner, if any, thereof (including by providing a copy of any written communication or a written account of any oral communication), but in no event later than five (5) business days after receipt of such communication. Each Party will promptly notify the other Party and the Future Partner, if any, and provide such other Party and Future Partner, if any, with a copy, of any correspondence or other reports or complaints submitted to or received by the first Party from any regulatory authority in the Territory or from any other Third Party claiming that any Product promotional materials are inconsistent with a Product’s labeling or are otherwise in violation of applicable law or regulation. Each Party will provide the other Party and the Future Partner, if any, with a copy of any documents or reports filed with or received from any regulatory authority in the Territory with respect to a Product. In addition, NPS shall require that the Future Partner, if any, provide Nycomed with a copy of any documents or reports filed with or received from any regulatory authority in the U.S. with respect to a Product.

5.4 Adverse Events Reporting. Nycomed will provide NPS and the Future Partner, if any, with prompt written notice of any serious adverse drug event or reaction reports received by Nycomed with respect to Products in the Territory, including copies of any such written reports where available. NPS will provide Nycomed with prompt written notice of any serious adverse drug event or reaction reports received by NPS with respect to Products in any jurisdiction outside the Territory where NPS is, at such time, developing or marketing Products, including copies of any such written reports where available. NPS Shall require that the Future Partner, if any, provide Nycomed with prompt written notice of any serious adverse drug event

 

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or reaction reports received by the Future Partner with respect to Products in any jurisdiction outside the Territory where the Future Partner is, at such time, developing or marketing Products, including copies of any such written reports where available. Nycomed will be responsible for complying with adverse drug event reporting requirements in the Territory with respect to Products and will copy NPS on all correspondence with regulatory authorities in the Territory regarding the same. NPS will be responsible for complying with adverse drug event reporting requirements in jurisdictions outside the Territory where NPS is, at such time, developing or marketing Products and will copy Nycomed on all correspondence between NPS and the regulatory authorities in such jurisdictions regarding serious adverse drug events or reactions. NPS will have the right to redact such correspondence to remove information proprietary to NPS as applicable.

 

6. TRANSFER OF MANUFACTURE AND SUPPLY

6.1 License of Know-How . NPS and Nycomed agree to license the Know-How as set out in this Section 6.1 on a non-exclusive basis (it being understood that this Section 6.1 shall not limit any exclusive licenses granted pursuant to Section 2). The common aim of this Section 6 shall be to enable Nycomed to take over responsibilities relating to the manufacture of the Product, Drug Substance and Device and to develop and improve the Product, Drug Substance and Device and the manufacturing process. Both Parties undertake to use commercially reasonable efforts to achieve that overall purpose when executing this Section 6.

6.2 Assumption of Manufacture . Subject to Section 6.8, Nycomed shall use reasonable efforts to ensure supply of Products through itself or Third Parties, including, without limitation, the negotiation of supply and manufacturing obligations and amendment of Marketing Authorizations to permit such changed supply chain.

6.3 Contributions of NPS. NPS shall make available to Nycomed all of the Technical Information (including any manufacturing information) in its Control in the form reasonably available to NPS according to the lists and timeplans set out in Schedules 6.3(a) and 6.3(b). To the extent practicable, NPS shall accommodate Nycomed on any reasonable request to convert such Technical Information into another form that is required or requested by a Regulatory Authority. NPS shall use reasonable efforts to perform and undertake the activities listed in Schedules 6.3(a) and 6.3(b) of the Agreement. NPS hereby expressly grants to Nycomed all rights to conclude the undertaking set out in Section 6, including without limiting the entering into of agreements with Third Party suppliers and approaching the authorities for amendment of Marketing Authorizations and Approvals. Any Technical Information not contemplated by Schedules 6.3(a) and 6.3(b) and that has not already been provided by NPS to Nycomed shall be made available to Nycomed upon Nycomed’s reasonable request to the extent reasonably available to NPS. NPS shall continue current efforts through [*] to undertake the actions and to resolve current problems relating to the supply chain of Products described in Schedules 6.3(a) and 6.3(b).

6.4 Subsequent Technical Information . Any Technical Information which comes under the Control of NPS or its Affiliates after the transfer according to Section 6.3 and during the Term shall be submitted to Nycomed as soon as reasonably practicable after it becomes available to NPS. NPS shall use reasonable efforts to not, and use reasonable efforts to cause its Affiliates to not, enter into any agreement with any entity which prevents Technical

 

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Information obtained as a result of such agreement being made available to Nycomed. Any Technical Information which comes under the Control of Nycomed or its Affiliates after the transfer according to Section 6.3 and during the Term shall be submitted to NPS as soon as reasonably practicable after it becomes available to Nycomed. Nycomed shall use reasonable efforts to not, and use reasonable efforts to cause its Affiliates to not, enter into any agreement with any entity which prevents Technical Information obtained as a result of such agreement being made available to NPS.

6.5 Nycomed Technical Information . Any Technical Information which is developed or acquired by Nycomed or its Affiliates or its sublicensees during the term of this Agreement shall be the property of Nycomed. Any Technical Information which is developed or acquired by NPS or its Affiliates or its sublicensees during the term of this Agreement shall be the property of NPS. To the extent that the Technical Information is an Improvement Sections 2.7 and 3.1 shall apply.

6.6 Master Cell Bank and Working Cell Bank . NPS is currently a party to a certain Laboratory Services and Confidentiality Agreement, dated as of [*], by and between NPS and [*], under which [*] performs certain contract research duties for NPS. As promptly as practicable after the Effective Date, NPS shall transfer to [*] or ATCC Patent Depository, which is in the business of maintaining legal compliant storage of materials for patent purposes (“ ATCC ”), or another Third Party appointed by NPS and approved by Nycomed, such approval not to be unreasonably withheld or delayed, the Master Cell Bank and Working Cell Bank and the technology related thereto under a trust agreement allowing royalty free access to Nycomed, NPS and the Future Partner in such a manner as to prevent either party from depleting these materials such that harm is caused to the other party. As part of such trust agreement, a mechanism for storage fees, withdrawals and manufacture of additional Working Cell Banks will be defined. Nycomed and NPS (or their respective assignee or sublicense) shall each cover fifty percent (50%) of the total costs and expenses of the activities required to maintain such trust. Until the trust agreement is in place, NPS shall deliver to Nycomed Master Cell Banks or Working Cell Banks or Drug Substance as needed by Nycomed for purposes of performing its obligations hereunder.

6.7 Parent Strain [*]. As promptly as practicable after the Effective Date, NPS shall transfer to [*] or ATCC or another a Third Party appointed by NPS and approved by Nycomed, such approval not to be unreasonably withheld or delayed, the parent strain [*] of the Master Cell Bank and the technology related thereto under a trust agreement allowing royalty free access to both Nycomed and the Future Partner in such a manner as to prevent either Party from depleting these materials such that harm is caused to the other Party. As part of such trust agreement, a mechanism for storage fees, withdrawals and manufacture of additional Master Cell Banks will be defined. Nycomed shall cover its portion of the activities required to maintain such trust.

6.8 Release from Manufacturing Obligations. Nycomed shall have the option, in its sole discretion, to assume the supply obligations relating to the Products as set forth in this Section 6.8. Nycomed shall so elect to release NPS from the supply obligations relating to the Products by executing and delivering to NPS the Release Certificate substantially in the form set out in Schedule 6.8 no later than midnight on September 1, 2007. Upon delivery of the executed Release Certificate by midnight on September 1, 2007, the grant of rights to the New Territories shall become permanent. In the event Nycomed delivers the executed Release Certificate as set forth above, the Distribution Agreement shall be terminated in accordance with

 

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Section 2.11 and the Supply Agreement shall be ter


 
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