DEVELOPMENT AND LICENSE AGREEMENT

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DURECT CORP | NYCOMED DANMARK APS

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Title: DEVELOPMENT AND LICENSE AGREEMENT
Governing Law: Delaware Date: 3/15/2007

DEVELOPMENT AND LICENSE AGREEMENT, Parties: durect corp , nycomed danmark aps

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

Exhibit 10.48

DEVELOPMENT AND LICENSE AGREEMENT

BETWEEN

DURECT CORPORATION

AND

NYCOMED DANMARK APS

DATED AS OF

NOVEMBER 29 ^TH , 2006

DEVELOPMENT AND LICENSE AGREEMENT

THIS DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”), effective as of November 29 ^th , 2006 (“Effective Date”), is entered into by and between DURECT Corporation, a corporation organized and existing under the laws of the State of Delaware, having offices located at 2 Results Way, Cupertino, CA 95014 (“DURECT”), and NYCOMED Danmark ApS, a corporation organized under the laws of the Denmark, having offices located at Langebjerg 1, DK-4000 Roskilde, Denmark (“NYCOMED”).

PRELIMINARY STATEMENTS

A. DURECT owns and controls rights in and to the product known as SABER™-Bupivacaine or POSIDUR™ currently under development by DURECT.

B. NYCOMED is a pharmaceutical company possessing substantial expertise in the development and marketing of pharmaceutical products.

C. NYCOMED desires to participate in the development of such product and obtain a license for commercialization rights to such product in a specified territory, and DURECT desires NYCOMED to participate in such development and to grant such license for commercialization rights in such territory to NYCOMED.

D. DURECT and NYCOMED wish to enter into this Agreement to specify the rights and obligations of the parties with respect to the license for commercialization of the product granted herein, including the rights and obligations of the parties with respect to the development and commercialization of such product in the specified territory.

NOW THEREFORE, in consideration of the mutual covenants and agreements provided herein, the parties hereby agree as follows:

1. DEFINITIONS.

As used in this Agreement, the following terms shall have the meanings set forth in this Section 1:

* * * 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.

1.1 “ Affiliate ” means a Person or entity that directly or indirectly through one or more intermediates, controls, is controlled by, or is under common control with the person or entity specified. For the purpose of this definition, “control” shall mean with respect to an entity, the direct or indirect ownership of (a) more than fifty percent (50%) of the capital stock or share capital entitled to vote for the election of directors of the entity or (b) more than fifty percent (50%) of equity or voting interest of the entity. An entity will be an Affiliate for purposes of this Agreement only so long as it satisfies the definition set forth herein.

1.2 “ Applicable Laws ” shall mean all applicable laws, rules, regulations and guidelines 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, distributions and sale of the Product in the Territory, to the extent applicable and relevant, and including all MAAs in each Jurisdiction, all cGMP or Good Clinical Practices Standards or guidelines promulgated by the FDA, the EMEA or other Regulatory Authorities and including trade association guidelines, where applicable, as well as the U.S. export control laws and the U.S. Foreign Corrupt Practices Act.

1.3 “ cGMP ” shall mean current good manufacturing practice for medicinal products for human use as set forth in Commission Directive 2003/94/EC the EU Good Manufacturing Practice guideline, Volume 4 for medicinal products for Human and Veterinary Use, the European Pharmacopoeia and 21 U.S. Code of Federal Regulations parts 210 and 211, in each case, as amended from time to time.

1.4 “ Clinical ” when used with respect to studies or data refers to studies in humans.

1.5 “ Clinical Trial ” means an investigation in human subjects and/or patients intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the objective of ascertaining its safety and/or efficacy.

1.6 “ CMC ” means chemistry, manufacturing and controls.

1.7 “ Committee ” shall mean any of the “Joint Executive Committee” (JEC), the “Joint Development Committee” (JDC) or “Commercialization Committee” (CC) and, when used in the plural, shall mean all of them or more than one of them, as the case may be.

1.8 “ Commercialization ” or “ Commercialize ” shall mean the ongoing process and activities generally engaged in by a company marketing human pharmaceutical therapeutic products to establish and maintain a presence for such product in a given territory, including offering for sale, selling, marketing, promoting, distributing, importing and exporting such product.

1.9 “ Commercially Reasonable Efforts ” with respect to any activity shall mean the efforts that an established pharmaceutical company would devote to such activity with respect to its own comparable product, taking into account the reasonable sales and profitability potential of the product while promoting the therapeutic profile and benefits of the product in the most commercially reasonable beneficial and responsible manner, duly respecting external factors outside the Party’s control.

1.10 [* * *]

1.11 “ Control ” or “ Controlled ” means possession by a Party or its Affiliate of the right to grant to the other Party a license, sublicense or other right to use, of the scope provided for in this Agreement, to intangible or Intellectual Property Rights (including patent rights, Know-How, trade secrets, data and rights to access or cross-reference regulatory filings) without violating the terms of any Applicable Law, agreement or other arrangement with any Third Party existing at the time such Party or such Affiliate would be first required hereunder to grant the other Party such license, sublicense or other right.

1.12 “ Cost ” shall mean all internal and external costs, expenses, cost of labor and materials associated with an activity – see specifically also section 1.14 and section 1.38.

1.13 “ CTA ” shall mean a Clinical Trial Application filed with the EMEA or other applicable Regulatory Authority for authorization to commence Clinical Trials in a Jurisdiction.

1.14 “ Development Costs ” shall mean the Costs of performing the Development Program as calculated in accordance with Schedule 1.14. [* * *]

1.15 “ Development Data ” means all Preclinical, Non-Clinical and Clinical data, including pharmacological, pharmacokinetic and toxicological data and all data included in any Regulatory Documentation, generated with respect to the Product that is Controlled at any time during the Term of this Agreement by a Party, or any Affiliate, subcontractor, agent, sublicensee thereof, or jointly by any of the foregoing.

1.16 “ Development Program ” shall mean the activities undertaken under this Agreement for developing and obtaining Regulatory Approval to Commercialize the Product in the EU and in the U.S. as described in the JDP.

1.17 “ Dosage Form Development ” means any pharmaceutical development activities for the Product that are necessary to design or modify a pharmaceutical formulation or dosage form to meet the desired Clinical or commercial drug delivery and dosing profile, as applicable, therefor, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, crystallization, micronization, excipient selection, compounding, mixing, sterilization, filtration and similar activities.

1.18 “ DURECT Know-How ” means Know-How related to the Product that is (a) Controlled by DURECT or any of its Affiliates during the Term of this Agreement and (b) useful for a Party, or its Affiliates and/or licensees to develop, make, have made, use, Commercialize and/or register the Product.

1.19 “ DURECT Technology ” means all Patents, DURECT Know-How and Inventions that are Controlled by DURECT or any of its Affiliates during the Term of the Agreement.

1.20 “ EEA ” shall mean the member states of the European Union and Norway, Iceland and Lichtenstein.

1.21 “ EMEA ” shall mean the European Medicines Agency and where and if applicable the European Commission, the Council of the European Union and the Committee for Medicinal Products for Human Use or any successor thereto.

1.22 “ EU ” shall mean the European Union including each of the member states as modified from time to time.

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

1.24 “ Field ” shall mean all pharmaceutical applications for human health.

1.25 “ First Commercial Sale ” shall mean: (i) with respect to a Jurisdiction, the first sale for use, consumption or resale of Product by NYCOMED or an Affiliate or Sublicensee thereof to a Third Party in a bona fide arms’-length transaction in such Jurisdiction and (ii) with respect to the Territory, the First Commercial Sale in any Jurisdiction. A sale to an Affiliate shall not constitute a First Commercial Sale unless the Affiliate is the end-user of the Product. For avoidance of doubt, the provision of free samples of the Product shall not be construed to constitute a sale of the Product for purposes of this definition.

1.26 “ GAAP ” shall mean generally accepted accounting principles in the United States, consistently applied by the Party at issue.

1.27 “ Generic Product ” means any generic controlled release injectable bupivacaine pharmaceutical product that is bioequivalent to, substitutable for and is approved for the same labeled indication as the Product and is sold under Article 10 of the EU Directive 2001/83/EC or other Applicable Laws of the relevant Jurisdiction following the later of expiry in such Jurisdiction of: (i) the Marketing Exclusivity Rights for the Product or (ii) the last Patent containing one or more Valid Claims that would be infringed by the development, manufacture, sale, offer for sale, use, importation or exportation of such generic product.

1.28 “ Governmental Entity ” shall mean any regional, central, federal, state, provincial or local court, commission or governmental, regulatory or administrative body, board, bureau, agency, instrumentality, authority or tribunal or any subdivision thereof.

1.29 “ ICH Guidelines ” shall mean the then-current guidelines applicable to pharmaceutical products adopted by the International Conference on Harmonization.

1.30 “ Intellectual Property Rights ” shall mean patents, copyrights, trade secrets, database rights, proprietary know-how and similar rights of any type (excluding trademarks) under the laws of any Governmental Entity, including all applications, registrations, extensions and renewals relating to any of the foregoing.

1.31 “ Inventions ” means all Know-How related to Product (whether or not patentable) conceived and/or reduced to practice by or for a Party, or any Affiliate, subcontractor, agent, sublicensee thereof, or jointly by any of the foregoing, arising out of or in connection with performing the activities under this Agreement including the JDP.

1.32 “ Jurisdiction ” means a country within the Territory.

1.33 “ Know-How ” means all technical information and other technical subject matter, proprietary methods, ideas, concepts, formulations, discoveries, inventions, devices, technology, trade secrets, compositions, designs, formulae, know-how, show-how, specifications, drawings, techniques, results, processes, methods, procedures and/or designs whether or not patentable.

1.34 “ MAA ” shall mean a “Marketing Authorization Application” or other application for approval to market the Product submitted to the Governmental Entity of any Jurisdiction, including any Marketing Authorization, as amended or supplemented from time to time.

1.35 “ Marketing Authorization ” or “MA” means any registrations or authorizations (including the approval of an MAA) issued under Directive 2001/83/EC (as amended by Directive 2004/27) or local legislation deriving thereof, Council Regulation 726/04 and any amendments or replacements thereof or any national equivalents in relation to the Product.

1.36 “ Major Market Country ” shall mean any one of the following Jurisdictions: Germany, France, United Kingdom, Spain or Italy.

1.37 “ Manufacture ” shall mean any processes and operations with respect to manufacture of the Product including from the starting materials to semi-finished to the finished Product. This includes but is not limited to processing, filling, inspections, in-process controls, packaging, quality controls, quality assurance, release of Product, storage and preparing finished Product ready for shipment.

1.38 “ Manufacturing Cost ” shall mean [* * *]. The Supply Agreement shall specify the calculation of Manufacturing Cost.

1.39 “ Marketing Exclusivity Right ” means a marketing or data exclusivity right conferred as a result of (a) Article 10 of EU Directive 2001/83/EC and/or Article 3(3) of EU Regulation 726/2004/EC or (B) EU Regulations 141/2000/EC and/or 847/2000/E, as applicable,

or any equivalent or similar rights in the Territory or Jurisdiction, successor legislations of any of the foregoing or subsequent legislation that has the effect of extending marketing or data exclusivity right to a pharmaceutical product.

1.40 “ Non-Clinical ” when used with respect to studies or data refers to safety, toxicology and other studies undertaken in non-human animals in support of Clinical Trials or otherwise required for Regulatory Approval.

1.41 “ NDA ” shall mean a “New Drug Application,” or other application for Regulatory Approval to market a product in the U.S. submitted to the FDA as amended or supplemented from time to time.

1.42 “ Net Sales ” means the total amount invoiced by NYCOMED, and/or its Affiliates and Sublicensees for sale or other commercial disposition of the Product (in its final, finished form for use by the end-user) to an unrelated Third Party in arms’-length transactions, less the following deductions in their normal and customary amounts:

(a) all trade, cash and quantity credits, discounts, refunds or rebates, including without limitation rebates accrued, incurred or paid to assistance program and any other price reduction required by governmental agency;

(b) allowances or credits for returns, including without limitation amounts received for sales which become the subject of a subsequent temporary or partial recall by regulatory agency for safety or efficacy reasons outside the control of NYCOMED, and retroactive price reductions (including managed care and similar types of rebates);

(c) Freight, postage, shipping, insurance, and packaging costs and other outbound transportation charges prepaid or allowed; and

(d) cost of export licenses and any taxes (excluding income taxes or similar taxes) fees or other charges associated with the exportation or importation of the Product.

For clarity, Net Sales shall be determined in accordance with GAAP and a sale or transfer by NYCOMED to its Affiliates and/or Sublicensees for resale by such Affiliate and/or Sublicensee shall not be considered a sale for the purpose of this provision but the resale by such Affiliate and/or Sublicensee to a Third Party shall be a sale for such purposes. Transfer for Preclinical Trials and Clinical Trials, testing or market research or promotional purposes shall not be a sale for the purpose of calculating Net Sales.

1.43 “ Party ” shall mean DURECT or NYCOMED, as the case may be, and, when used in the plural, shall mean DURECT and NYCOMED.

1.44 “ Patents ” means the patents and patent applications identified on Schedule 1.44 related to Product in the Territory, all patents issuing from any such applications, and any other patents in the Territory issuing from applications that claim the same priority entitlement as any of the patents and patent applications identified on Schedule 1.44, and to the extent applicable to the Product in the Territory and Controlled by DURECT or any of its Affiliates at any time during the Term of this Agreement: (i) all other patents and patent applications (including those covering design or utility models) that relate to the Product (including components thereof), its formulation or composition, or method of manufacture or use, (ii) all other patents and patent applications that relate to DURECT Know-How, (iii) all patents and patent applications to Inventions owned by DURECT under Section 9.1 and (iv) any provisionals, continuations, divisionals, continuation-in-part applications, substitutions, reissues, renewals, re-examinations, supplementary protection certificates, extensions, registrations, confirmations, successor protective rights or subsequently issued protective rights of similar nature of any of the above.

1.45 “ Person ” shall mean an individual or a corporation, partnership, association, trust, or any other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.

1.46 “ POSIDUR ™” shall mean the trademark rights to the mark POSIDUR and similar rights under the laws of any Governmental Entity, including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating thereto.

1.47 “ Preclinical ” when used with respect to studies or data refers to preliminary pharmacological studies undertaken in non-human animals, but not necessarily for purposes of submission in support of Regulatory Approval.

1.48 “ Pricing ” or “ Pricing Approval ” shall mean any approval or authorization of any Governmental Entity, establishing a pricing scheme for Product in the Territory.

1.49 “ Product ” shall mean DURECT’s formulated product for use in the Field currently known as SABER™-Bupivacaine or POSIDUR™ as of the Effective Date as described in Schedule 1.49 hereto. Product shall include all, reformulations, line extensions and/or improvements which come into existence in accordance with Section 2.1(b)(v), [* * *].

1.50 “ Regulatory Approval ” shall mean, with respect to one or more countries, final approval of the Regulatory Approval Application for the Product filed in such country(ies) including an approved NDA in the U.S. or MA in the EU and approved Pricing and Reimbursement, or equivalent local final approvals in Jurisdictions outside of the EU.

1.51 “ Regulatory Approval Application ” shall mean a new drug application, health registration, marketing authorization application, common technical document, regulatory submission, notice of compliance or equivalent application (excluding local and general business licenses and permits) required to be approved before commercial sale or use of the Product as a pharmaceutical or medicinal product (including any Pricing and Reimbursement Approvals) in a country, together with all subsequent submissions, supplements and amendments thereto, including an NDA in the U.S. or MAA in the EU or local approvals in the Non-EU Jurisdictions.

1.52 “ Regulatory Authority ” shall mean the EMEA, FDA, and any health regulatory authorities in the Territory or Jurisdiction that hold responsibility for the regulation of and/or the Reimbursement of medicinal products intended for human use.

1.53 “ Regulatory Documentation ” shall mean all submissions to Governmental Entities, including for Clinical Trials, tests, and biostudies, relating to the Product, including all CTAs and MAAs, as well as all correspondence with Governmental Entities (registration and licenses, Pricing and Reimbursement correspondence, regulatory drug lists, advertising and promotion documents), adverse event files, complaint files, manufacturing records and inspection reports.

1.54 “ Reimbursement ” or “ Reimbursement Approval ” shall mean the official decision by the relevant reimbursing body in any Jurisdiction establishing a reimbursement scheme to cover the costs related to the treatment of patients with the Product.

1.55 “ SABER ^TM Delivery System ” means DURECT’s injectable non-polymeric, high viscosity liquid carrier system for imparting controlled release to active ingredients, including any and all Intellectual Property Rights therein and thereto.

1.56 [* * *]

1.57 “ Specifications ” shall mean the specifications for the Product as agreed upon by the JDC, considering the applicable regulatory requirements in the Territory and U.S., as may be amended from time to time.

1.58 “ Territory ” shall mean the countries listed in Schedule 1.58 hereto, as modified from time to time in accordance with the terms of this Agreement.

1.59 “ Third Party ” shall mean any Person who or which is neither a Party nor an Affiliate of a Party.

1.60 “ Unit ” shall mean a single vial of the Product as Commercialized in the Territory corresponding to one treatment.

1.61 “ U.S. ” shall mean the United States of America, including all states and territories.

1.62 “ Valid Claim ” means a claim [* * *].

1.63 Other Definitions .

Each of the following terms is defined in the Section set forth opposite such term below:

[* * *]

“ Adverse Event ” –Section 4.8.

“ Agreement ” —Preamble

“ Accelerated Arbitration Provisions ” —Section 14.12(c)

“ Annual Net Sales Period ”—Section 6.2(a)

“ Audited Party ” — Section 7.4

“ Auditing Party ” — Section 7.4

“ CEO Resolution Period ” – Section 2.1(d)

“ Clinical Trial Supplies ”—Section 4.3(f)

“ Commercialization Committee ” or “ CC ” — Section 2.3(a)

“ Confidential Information ”—Section 10.4

“ CMO ”—Section 8.1

“ CRO ”—Section 13.8(d)

“ Damages ” — Section 12.1

[* * *]

“ JDP Budget ” — Section 4.1

“ Dispute ” —Section 14.12(b)

[* * *]

“ DURECT ”—Preamble

“ DURECT Related Party ”—Section 12.2

“ Effective Date ” —Preamble.

“ Expedited Rules ” — Section 14.12(c)

“ Force Majeure ”— Section 14.14

“ Indemnified Party ” —Section 12.4.

“ Indemnifying Party ” — Section 12.4

“ JDP Budget ” – Section 4.1

“ Joint Development Committee ” or “ JDC ” — Section 2.2(a)

“ Joint Development Plan ” or “ JDP ” — Section 4.1

“ Joint Executive Committee ” or “ JEC ” — Section 2.1(a)

“ Know-How Royalty Term ” — Section 6.2(b)

“ Marketing Plan ” –Section 5.2.

[* * *]

“ Non-EU Jurisdictions ”—Section 4.3(d)

“ NYCOMED ”—Preamble

“ NYCOMED Related Party ”—Section 12.1

“ One-Time Payment ”—Section 6.1

“ Patent Term Extensions ” —Section 9.3.

“ Patent Royalty Term ” —Section 6.2(a)

“ Pharmacovigilance Agreement ” –Section 4.8

“ Post-Registration Plan ” –Section 4.2

[* * *]

“ Relevant Third Party Claim ”—Section 9.6(b)

“ Relevant Third Party Infringement ”—Section 9.4(a)(i)

“ Royalties ” —Section 6.2

“ Rules ” – Section 14.12 (b)

[* * *]

“ Serious Adverse Drug Experience ”—Section 13.2

“ SPC ”—Section 9.3.

[* * *]

“ Sublicense ” — Section 3.1(b)

[* * *]

“ Supply Agreement ”—Section 8.1

“ Technical Agreement ” – Section 8.1

“ Terminated Countries ”—Section 5.6

“ Transfer Price ” — Section 8.2

1.64 Interpretation

(a) Whenever any provision of this Agreement uses the term “including” (or “includes”), such term shall be deemed to mean “including without limitation” and “including but not limited to” (or “includes without limitations” and “includes but is not limited to”) regardless of whether the words “without limitation” or “but not limited to” actually follow the term “including” (or “includes”);

(b) “Herein”, “hereby”, “hereunder”, “hereof” and other equivalent words shall refer to this Agreement in its entirety and not solely to the particular portion of this Agreement in which any such word is used;

(c) All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

(d) Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

(e) The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recital, Exhibits and Schedules shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided , that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

(f) In the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, verbal agreement or otherwise, the terms and conditions of this Agreement shall govern;

(g) The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

(h) Unless otherwise provided, all references to Sections, Schedules and Exhibits in this Agreement are to Sections, Schedules and Exhibits of and to this Agreement;

(i) All references to days, months, quarters or years are references to calendar days, calendar months, calendar quarters or calendar years unless otherwise expressly provided; references to a “business day” herein shall mean a day when both NYCOMED and DURECT corporate headquarters are open during regular business hours for the conduct of normal business operations.

(j) Any reference to any federal, national, state, local or foreign statute or law shall be deemed to also refer to all rules and regulations promulgated thereunder, unless the context requires otherwise;

(k) Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 14.5; and

(l) Wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another.

2. GOVERNANCE.

2.1 Joint Executive Committee .

(a) Members; Officers . The Parties hereby establish a joint executive committee (the “ Joint Executive Committee ” or “ JEC ”), which shall consist of up to [* * *] members with an equal number of members from each of DURECT and NYCOMED. The initial members of the JEC are set forth on Schedule 2.1, as may be amended by the designating Party from time to time. Representatives of the JEC shall be employees of the respective Party. Each of DURECT and NYCOMED may replace any or all of its representatives on the JEC at any time upon written notice to the other Party. Any member of the JEC may designate a substitute with due authority to temporarily attend and perform the functions of that member at any meeting of the JEC. DURECT and NYCOMED each may, in its discretion, invite non-member representatives that are employees (unless otherwise agreed to in writing by the Parties) of such Party to attend meetings of the JEC. [* * *].

(b) Responsibilities . The JEC shall perform the following functions:

(i) manage and oversee the interactions and performance of the Parties pursuant to the terms of this Agreement (hereunder the development, Regulatory Approval process in the U.S. and the Territory), [* * *];

(ii) review and decide strategic decisions and other strategic matters referred to the JEC by the JDC;

(iii) [* * *];

(iv) [* * *];

(v) [* * *];

(vi) [* * *];

(vii) [* * *];

(viii) [* * *];

(ix) [* * *];

(x) [* * *];

(xi) [* * *]; and

(xii) have such other responsibilities as may be assigned to the JEC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

(c) Meetings . The JEC shall meet in person, by video teleconference or by telephone initially at least [* * *], and more frequently as DURECT and NYCOMED deem appropriate or as required to resolve disputes, disagreements or deadlocks in the JDC, on such dates, and at such places and times, as the Parties shall agree. From time to time, each Party may request a JEC meeting upon notice to the other Party specifying the subject matters to be discussed, and the Parties shall convene such JEC meeting [* * *] business days of the date of the notice. Meetings of the JEC that are held in person shall alternate between the offices of DURECT and NYCOMED, or such other place as the Parties may agree. The members of the JEC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate.

(d) Decision-making . The JEC may make decisions with respect to any subject matter that is subject to the JEC’s decision-making authority and functions as set forth in Section 2.1(b). All decisions of the JEC shall be made by unanimous vote or written consent, with DURECT and NYCOMED each having, collectively, one vote in all decisions. The JEC shall use Commercially Reasonable Efforts to resolve the matters within its roles and functions or otherwise referred to it. With respect to all matters that are subject to the JEC’s decision-making authority, if the JEC cannot reach consensus within [* * *] business days after it has met and attempted to reach such consensus, the matter shall be referred on the eleventh business day to the chief executive officers (“ CEOs ”) of NYCOMED and DURECT who shall meet as soon as practicable, but no later than [* * *] business days after such referral, to

attempt in good faith to resolve the dispute. If the dispute is not resolved by the CEOs by mutual agreement within [* * *] business days after a meeting to discuss the dispute (such [* * *] business day period after the meeting of the CEOs shall be referred to as the “ CEO Resolution Period ”), the dispute shall be resolved as follows:

(i) [* * *]

(ii) [* * *]

(iii) If the dispute concerns any matter other than set forth in Sections 2.1(d)(i) and (ii), then either Party may at any time thereafter provide the other Party notice of its decision to institute dispute resolution procedures under Section 14.12, provided, however, that Section 14.12(a) shall not apply.

2.2 Joint Development Committee .

(a) Members; Officers . The Parties hereby establish a joint development committee (the “ Joint Development Committee ” or “ JDC ”), which shall consist of equal number of representatives from each of DURECT and NYCOMED, up to [* * *] members from each Party on such Committee unless otherwise agreed to by the Parties in writing. The initial representatives on the JDC are set forth on Schedule 2.2, as may be amended by the designating Party from time to time. Each of DURECT and NYCOMED may replace any or all of its representatives on the JDC at any time upon notice to the other Party. Such representatives shall be employees of each such Party, and those representatives of each such Party shall, individually or collectively, have expertise in pharmaceutical drug development, regulatory matters, Clinical Trials, and/or other expertise to the extent relevant. Any member of the JDC may designate a substitute with due authority to temporarily attend and perform the functions of that member at any meeting of the JDC. DURECT and NYCOMED each may, in its discretion, invite non-member representatives that are employees of or external consultants retained by either NYCOMED or DURECT (unless otherwise agreed to in writing by the Parties) to attend meetings of the JDC, provided that such external consultants have signed customary confidentiality agreements. [* * *] The secretary of the JDC shall [* * *].

(b) Responsibilities . The JDC shall perform the following functions:

(i) oversee the implementation of the Development Program in accordance with the JDP;

(ii) oversee the development of the Product in Non-EU Jurisdictions;

(iii) [* * *];

(iv) [* * *];

(v) [* * *];

(vi) [* * *];

(vii) [* * *];

(viii) [* * *];

(ix) [* * *];

(x) [* * *];

(xi) [* * *];

(xii) [* * *];

(xiii) [* * *];

(xiv) [* * *]; and

(xv) have such other responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

(c) Meetings . The JDC shall meet in person, by video teleconference or by telephone initially at least [* * *], and more or less frequently as DURECT and NYCOMED deem appropriate or as reasonably requested by either such Party, on such dates, and at such places and times, as such Parties shall agree. From time to time, each Party may request a JDC meeting upon written notice to the other Party specifying the subject matters to be discussed, and the Parties shall convene such JDC meeting within [* * *] business days of the date of the

notice. Meetings of the JDC that are held in person shall alternate between the offices of DURECT and NYCOMED, or such other place as such Parties may agree. The members of the JDC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate.

(d) Decision-making . The JDC may make decisions with respect to any subject matter that is subject to the JDC’s decision-making authority and functions as set forth in Section 2.2(b). All decisions of the JDC shall be made by unanimous vote or written consent, with DURECT and NYCOMED each having, collectively, one vote in all decisions. If, with respect to any matter that is subject to the JDC’s decision-making authority, after all reasonable efforts to reach consensus have been exhausted, the JDC cannot reach consensus within [* * *] business days after it has first met and attempted to reach such consensus, the matter shall be referred on the [* * *] business day to the JEC for resolution. For all purposes under this Agreement, any decision made pursuant to this Section 2.2(d) shall be deemed to be the decision of the JDC.

2.3 Commercialization Committee .

(a) Members; Officers . At such time as NYCOMED deems appropriate, however not later than upon the submission of MAA in the EU, NYCOMED shall establish a commercialization committee (the “ Commercialization Committee ” or “ CC ”), which shall consist of representatives from each of DURECT and NYCOMED. Each of DURECT and NYCOMED may replace any or all of its representatives on the CC at any time upon written notice to the other Party. Such representatives shall be employees of each such Party, and those representatives of each such Party shall, individually or collectively, have expertise in marketing and sales of pharmaceutical products. Any member of the CC may designate a substitute with due authority to temporarily attend and perform the functions of that member at any meeting of the CC. DURECT and NYCOMED each may, in its discretion, invite non-member representatives that are employees of or external consultants retained by either NYCOMED or DURECT (unless otherwise agreed to in writing by the Parties) to attend meetings of the CC, provided that such external consultants have signed customary confidentiality agreements. [* * *] The CC shall not have any decision-making authority unless otherwise agreed in writing between the Parties.

(b) Responsibilities . The CC shall perform the following functions:

(i) [* * *];

(ii) [* * *];

(iii) [* * *];

(iv) [* * *];

(v) [* * *];

(vi) [* * *];

(vii) [* * *];

(viii) [* * *];

(ix) [* * *];

(x) [* * *] ;

(xi) [* * *];

(xii) [* * *]; and

(xiii) have such other responsibilities as may be assigned to the CC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

(c) Meetings . The CC shall meet in person, by video teleconference or by telephone at least [* * *], and more frequently as NYCOMED deems appropriate or as reasonably requested by either such Party, on such dates, and at such places and times, as such Parties shall agree. From time to time, each Party may request a CC meeting upon written notice to the other Party specifying the subject matters to be discussed, and the Parties shall convene such CC meeting within [* * *] business days of the date of the notice. Meetings of the CC that are held in person shall alternate between the offices of DURECT and NYCOMED, or such other place as the Parties may agree. The members of the CC may also

convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate.

2.4 Minutes of JEC and JDC Meetings .

(a) Subject to Section 2.4(b), definitive minutes of all JEC and JDC meetings shall be finalized no later than [* * *] business days after the meeting to which the minutes pertain, as follows:

(i) Within [* * *] business days after a JEC or a JDC meeting, the secretary of such JEC or JDC shall prepare and distribute to all members of such JEC or JDC draft minutes of the meeting. [* * *].

(ii) The secretary of such JEC or JDC shall have [* * *] business days after distribution of the draft minutes to discuss each JEC or JDC member’s comments and finalize the minutes. The secretary and chairperson(s) of such JEC and JDC shall each sign and date the final minutes. The signature of such chairperson(s) and secretary upon the final minutes shall indicate each Party’s assent to the minutes.

(b) If at any time during the preparation and finalization of JEC or JDC meeting minutes, the JEC and JDC members do not agree on any issue with respect to the minutes, such issue shall be resolved as provided in Section 2.1(d) or 2.2(d), as the case may be. The decision resulting from the foregoing process shall be recorded by the secretary in amended finalized minutes for said meeting. All other issues in the minutes that are not subject to the foregoing process shall be finalized within the [* * *]business day period as provided in Section 2.4(a).

2.5 Term . [* * *]

2.6 Expenses . [* * *]

2.7 Scope of Committees . NYCOMED and DURECT have chartered the Committees with a belief that vigorous interaction and cooperation between the Parties are essential for the success of the Product. For the JEC and JDC, each Party shall use all reasonable efforts to reach consensus decisions at the JEC or JDC level respectively. Nothing in this Section 2, and no decision made by the JEC or JDC under Sections 2.1(d) or 2.2 (d) shall be deemed to modify or

supersede any express term or condition set forth in this Agreement, nor any decision or decision-making authority expressly provided to a Party in this Agreement. For clarity, no Committee shall have the authority to make any determination that any Party is in breach of this Agreement.

3. GRANT OF RIGHTS.

3.1 Rights Granted to NYCOMED .

(a) On the terms and subject to the conditions of this Agreement and in consideration of the One-Time Payment and Royalties, DURECT hereby grants to NYCOMED (i) the exclusive right and license to Commercialize the Product in the Territory, including the right to record sales for its own account and (ii) an exclusive license (with rights to sublicense subject to Section 3.1(b) below) under the DURECT Technology solely for use in connection with NYCOMED’s Commercialization of the Product in the Territory and to otherwise exercise NYCOMED’s rights and perform its obligations under this Agreement including carrying out such Clinical Trials, filing of MAAs and amending Marketing Authorizations, in each case in the Territory, as contemplated under the terms of this Agreement.

(b) [* * *]

3.2 Exclusivity .

(a) During the Term of this Agreement, DURECT and its Affiliates shall not develop (except in performance of this Agreement) nor Commercialize, and shall not grant any rights or licenses to any Third Party to develop (except in performance of this Agreement) or Commercialize the Product in the Territory.

(b) [* * *].

(d) [* * *].

3.3 Activities Outside the Territory . NYCOMED acknowledges that DURECT retains all rights in and to the Product outside the Territory. [* * *]

3.4 Trademarks; Logos .

(a) [* * *]

(b) [* * *]

(d) [* * *]

4. DEVELOPMENT AND REGULATORY

4.1 Joint Development Plan . The “ Joint Development Plan ” or “ JDP ” agreed to by the Parties sets forth the Development Program including on a calendar year-by-calendar year basis through final Regulatory Approval in the EU and the U.S.: (i) the development, scientific, medical, regulatory and other activities including Clinical Trials, Non-Clinical studies, Dosage Form Development, manufacturing process development, scale-up and validation, CMC, ICH registration batches, pre-approval inspections and preparation, pharmaceutical development including quality control and stability and manufacturing qualification under this Agreement for the development of the Product through Regulatory Approval in both the U.S. and the EU; (ii) the estimated budget for each development activity, and estimated over-all budget for performance of all development activities under the JDP (“JDP Budget”); (iii) target Product profiles; (iv) timelines and (v) subject to Section 4.3, the allocation of the respective responsibilities of DURECT and NYCOMED regarding development activities. The JDP shall be updated by and reviewed by the JDC at least once [* * *] by a date no later than [* * *] so as to cover any other amendments, and each amendment shall be approved by the JEC.

4.2 Post-Registration Development . After Regulatory Approval of the Product in the EU, NYCOMED shall develop a plan for post-Registration development activities (including phase IV Clinical Trials), if applicable, to be performed for the purpose of providing marketing support for the Product in the Territory (“ Post-Registration Plan ”). [* * *]

4.3 Development of Product in the Territory . Under the supervision and auspices of the JDC, the Parties shall have the following responsibilities relating to development of the Product in the Territory:

(a) Notwithstanding anything herein to the contrary, DURECT or its designees shall at all times perform any Dosage Form Development, [* * *].

(b) DURECT and NYCOMED shall mutually agree and be jointly responsible for the preparation of all protocols of Clinical Trials and Non-Clinical studies (which shall be reviewed and approved by the JDC in accordance with Section 2.2(b)(x)) and the conduct of the Development Program in accordance with the JDP.

(c) NYCOMED shall be responsible for the preparation of all phase IV protocols [* * *] and the conduct of phase IV Clinical Trials and other activities set forth in the Post Registration Plan for the Territory.

(d) Subject to review by the JDC, NYCOMED shall perform, subject to Section 4.6 and 5.6, all development work not provided for in the JDP necessary for Regulatory Approval of the Product in all Jurisdictions in the Territory outside of the EU (the “ Non-EU Jurisdictions ”).

(e) DURECT shall be responsible for all development work not provided for in the JDP necessary for Regulatory Approval of the Product outside the Territory.

(f) DURECT shall supply all Product as necessary and/or desirable for development of the Product in the Territory (“ Clinical Trial Supplies ”). DURECT shall use Commercially Reasonable Efforts to supply Clinical Trial Supplies in accordance with, in all material respects, [* * *].

(g) In connection with performing its obligations to develop the Product, each of DURECT and NYCOMED shall use Commercially Reasonable Efforts to perform such responsibilities assigned to it hereunder. Without limiting the generality of the foregoing, each Party shall:

(i) cooperate with the other Party to implement the JDP, [* * *], and such other activities as contemplated in the Agreement;

(ii) use Commercially Reasonable Efforts to perform the work set out for such Party to perform in the JDP or otherwise set forth in this Agreement, in good scientific manner, and in compliance with all requirements of Applicable Laws to attempt to achieve the objectives of such plans efficiently and expeditiously; and

(iii) completely and accurately record in writing all work done and results achieved in connection with the development of the Product hereunder in the form required under all Applicable Laws.

4.4 Ownership and Exchange of Data and Know-How .

(a) During the Term of this Agreement, subject to applicable confidentiality agreements binding on such Party, each Party shall promptly provide to the other Party copies of all (i) Know-How related to the Product and Development Data that is in existence as of the Effective Date and that is developed, acquired or Controlled by such Party during the Term, as required or useful to perform the JDP and Post-Registration Plan or exercise its rights and obligations under the Agreement, as may be requested by a Party from time to time, and (ii) all material safety information concerning the Product of which it becomes aware.

(b) As between the Parties, DURECT shall own all Development Data. DURECT hereby grants NYCOMED the exclusive right and license in the Territory and in the Field during the Term to use all such Development Data for all purposes necessary to allow NYCOMED to exercise its rights and perform its obligations under this Agreement. [* * *]

4.5 Funding of Development .

(a) From and after the Effective Date, unless otherwise specifically provided for herein, each of DURECT and NYCOMED shall be responsible for the Development Costs listed below its name in the following table:


DURECT		NYCOMED
Fifty percent (50%) of the Development Costs under the JDP for the Product		Fifty percent (50%) of the Development Costs under the JDP for the Product
[* * *]		[* * *]
[* * *]		[* * *]
[* * *]		[* * *]

(b) With respect to those Development Costs to be shared between DURECT and NYCOMED pursuant to the above table, within [* * *] calendar days after the end of each month, DURECT and/or NYCOMED, as the case may be, shall provide to the other Party an invoice in an amount equal to the proportion of such Development Costs incurred by such Party in such month as in accordance with the JDP. Payment terms shall be net [* * *] days from the date of each Party’s receipt of any correct invoice. Payments shall be sent to the “Remit to” address set forth on the invoice. Each Party shall pay the other a late charge of [* * *] (or the maximum interest allowable by Applicable Law, whichever is less) for each invoice past due for more than [* * *] days from the date of such Party’s receipt of any correct invoice. Should a Party dispute any portion of an invoice, it shall not be required to pay any portion of such invoice until such time as the dispute is resolved and such disputing Party receives a fully corrected invoice; provided that, in such an event, the other Party shall have the option of issuing a new, correct invoice for the portion of the original invoice not in dispute, and the disputing Party shall pay such new invoice within the time limits set forth in this Section 4.5(b).

4.6 Regulatory Approvals .

(a) In the Territory . Except as otherwise provided under this Agreement or mutually agreed by DURECT and NYCOMED, during the Term of the Agreement, NYCOMED shall own all Regulatory Approvals for the Product in the Territory. Each Party shall in a timely manner provide the other Party with all Regulatory Documentation in such Party’s Control as reasonably requested by the other Party necessary for applying for such Regulatory Approval and CTAs. NYCOMED shall use Commercially Reasonable Efforts to obtain, Regulatory Approval including Pricing and Reimbursement Approval of the Product in each Jurisdiction necessary for Commercialization of the Product, provided however that [* * *] . To this end, NYCOMED shall use Commercially Reasonable Efforts to compile, submit and prosecute in a timely manner all necessary Regulatory Approval Applications, in a format acceptable to the applicable Regulatory Authorities in the Territory. NYCOMED shall submit proposed filings and correspondence to Regulatory Authorities in the Territory regarding major or material issues (e.g., [* * *]) to the JDC for its approval prior to submission to Regulatory

Authorities. NYCOMED shall keep the JDC informed as to the status of such efforts, permit the JDC to review any revisions to any filings or communications with Regulatory Authorities during their preparation, and shall confer with the JDC regarding the preparation of such filings and communications and the Regulatory Approval process. During such process, DURECT shall collaborate and cooperate with NYCOMED in the preparation and filing of all Regulatory Documentation necessary therefor and all regulatory interactions and compliance with Regulatory Authorities in the Territory. If and when any Regulatory Approval is secured anywhere in the Territory, NYCOMED shall thereafter use Commercially Reasonable Efforts to maintain and renew such Regulatory Approval and pay all user fees and other Costs required to obtain and maintain such Regulatory Approval. Promptly following the Effective Date, DURECT shall transfer to NYCOMED all CTAs held by DURECT for the Product in the Territory as set-out in JDP, if any, including any draft CTA documents, and copies of all correspondence and notes of any oral communication with Regulatory Authorities regarding the Product in the Territory. NYCOMED shall then be resp

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