EXHIBIT 10.8

 

CLINICAL DEVELOPMENT AND COLLABORATION AGREEMENT

 

THIS CLINICAL DEVELOPMENT AND COLLABORATION AGREEMENT (the “Agreement”) is made effective as of the 25th day of June, 2013 (the “Effective Date”), by and between NovaMedica, LLC (“NovaMedica”), a limited liability company organized under the laws of the Russian Federation with an address of 10113 bldg 38, Sokolnichesky Val Street Moscow Russian Federation, and Marinus Pharmaceuticals, Inc. (“Marinus” or “Company”), a corporation organized under the laws of the State of Delaware, USA, and having its place of business at 142 Temple Street, Suite 205, New Haven, Connecticut 06510, USA.  For the purposes of this Agreement, “Party” means NovaMedica and Marinus, individually, and “Parties” means NovaMedica and Marinus, collectively.

 

WHEREAS, NovaMedica is engaged in the business of the research, development and commercialization of pharmaceutical products in the Territory (as hereinafter defined); and

 

WHEREAS, Marinus is a development stage company engaged in the research, development and commercialization of certain products, including the Covered Products (as hereinafter defined); and

 

WHEREAS, Marinus and Domain Russia Investments Limited (“DRI”) entered into a Technology Transfer Agreement (“TTA”) dated as of December 4, 2012, pursuant to which Marinus transferred certain Marinus IP (as defined therein) to DRI; and

 

WHEREAS, on December 4, 2012, Marinus, DRI and NovaMedica entered into an Assignment and Assumption Agreement, pursuant to which DRI assigned the TTA in full to NovaMedica and under which NovaMedica agreed to accept such assignment of rights and to assume substantially all of DRI’s rights and obligations under the TTA; and

 

WHEREAS, pursuant to the TTA, the Parties are required to enter into this Agreement under which Marinus shall assist NovaMedica in the Development and Commercialization of the Covered Product in the Territory;

 

NOW, THEREFORE, in consideration of the foregoing and the mutual covenants and agreements set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound hereby, hereby agree as follows.

 

1.                                      DEFINITIONS

 

1.1                               “Clinical Data” shall have the meaning set forth in Section 4.2.3 (b).

 

1.2                               “Commercial Supplies” shall mean supplies of the Covered Products in suitable final packaged form, as specified under the Supply Agreement between the Parties, manufactured in compliance with GMP, and ready to be offered for commercial sale for use in the Field in the Territory by NovaMedica and/or Permitted Transferees.

 











 

1.3                               “Compound” means ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20-one), the chemical structure of which is described in Schedule 1, in any formulation, the use, Development or Commercialization of which in the absence of the TTA, a sublicense to a Permitted Transferee or other ownership, assignment or license of applicable rights, would infringe at least one Valid Claim of the Assigned IP or Company Patent Rights, or that is manufactured or otherwise produced, at least in part, using Company Know-How.

 

1.4                               “Confidential Information” of a Party means such Party’s confidential information relating to its business, operations and products, including but not limited to any technical information, formulae, processes, techniques, preclinical information, toxicology information, clinical, non-clinical, or pre-clinical information, regulatory information, Manufacturing information, formulation information, packaging information, dosing information, dose regimen information, target patient information, marketing information, sales information, pricing information, reimbursement information, Know-How, trade secrets, or inventions (whether patentable or not) that is disclosed to or learned by the other Party in connection with this Agreement. All Company Know-How shall be deemed Confidential Information of the Company.

 

1.5                               “Covered Product” means any pharmaceutical product (including, without limitation, any diagnostic product or therapeutic product) that (a) contains or comprises the Compound in any formulation designed and intended for use in and for the Field, whether or not combined with other compounds, (b) in the absence of the TTA, a sublicense to the Permitted Transferee or other ownership, assignment or license of applicable rights, would infringe at least one Valid Claim of the Assigned IP or Company Patent Rights, or (c) is manufactured or otherwise produced, at least in part, using Company Know-How.

 

1.6                               “Development” or “Develop” means the performance of all development activities, including any pre-clinical and clinical development activities, including, without limitation, toxicology, pharmacology, test method development and stability testing, process development, formulation development, quality control development, statistical analysis, Clinical Trials, and manufacturing and regulatory activities or any similar activities that are useful or otherwise required to obtain Regulatory Approval of a Covered Product in the Territory, including interacting with any Regulatory Authorities in the Territory regarding the foregoing.

 

1.7                               “Development Plan” shall have the meaning set forth in Section 3.2.

 

1.8                               “Drug Approval Application” shall mean an application to a Regulatory Authority for Regulatory Approval of the Covered Product in the Territory.

 

1.9                               “EMA” means the European Medicines Agency or any successor agency.

 

1.10                        “Excluded Field” means and includes the treatment of any unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage, including discomfort, either acute or chronic, caused by a primary lesion or dysfunction in the peripheral or central nervous system (e.g., neuropathic pain, post-herpetic neuralgia, trigeminal neuralgia), phantom pain, back pain, surgical pain, cancer pain, and pain associated with inflammation or damage of any tissues (e.g., muscle, bone, organs,

 

2











 

tendons, nerves, and skin) by disease, injury, infection, surgery, or at birth.  For avoidance of doubt, neither NovaMedica (nor any Permitted Transferee) shall be permitted hereunder to pursue or obtain any Regulatory Approval or labeling for a Covered Product as an analgesic or anesthetic agent or for the treatment of pain as a result of contractual restrictions imposed on Company by the License Agreement.

 

1.11                        “Field” means any and all prophylactic, palliative, therapeutic, and diagnostic uses for any human or animal disease or condition other than diseases, disorders and conditions that are in the Excluded Field; provided, however, that during the Term should any Excluded Field limitations imposed on Company by the License Agreement expire or be expanded, the “Field” under this Agreement shall thereafter be expanded on an equivalent basis.

 

1.12                        “IND” means an investigational new drug application filed with the FDA or the equivalent application or filing filed with any equivalent agency or Governmental Body outside the United States (including any supra-national entity such as in the European Union) for approval to commence a Clinical Trial in such jurisdiction.

 

1.13                        “Indication” means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition.  For the avoidance of doubt, all variants of a single disease or condition (whether classified by severity or otherwise) shall be treated as the same Indication.

 

1.14                        “Joint Commercialization Committee” or “JCC” has the meaning given in Section 3.3, below.

 

1.15                        “Joint Development Committee” or “JDC” has the meaning given in Section 3.2, below.

 

1.16                        “Joint Steering Committee” or “JSC” has the meaning given in Section 3.1, below.

 

1.17                        “Law” or “Laws” means all applicable laws, statutes, rules, regulations, ordinances, and other pronouncements having the binding effect of law of any Governmental Body.

 

1.18                        “NDA” means a New Drug Application filed pursuant to the requirements of the FDA, a Biologics License Application filed pursuant to the requirements of the FDA, and any equivalent application filed in any country outside of the Territory, together, in each case, with all additions, deletions, or supplements thereto.

 

1.19                        “Permitted Transferee” means an assignee, licensee or sublicensee of NovaMedica of any of the rights and licenses assigned to NovaMedica under the TTA in accordance with the terms of the TTA.

 

1.20                        “Regulatory Authority” means (a) the FDA, (b) the EMA, (c) any successor or equivalent of the foregoing; or (d) any regulatory body with regulatory authority or oversight over pharmaceutical or biotechnology products in any other jurisdiction anywhere in

 

3











 

the world, or whose review or approval is necessary for the Development, Manufacture and/or Commercialization of a Covered Product in a particular country or jurisdiction in the Territory.

 

1.21                        “Regulatory Approval” means, with respect to a particular Covered Product, any and all approvals, licenses, registrations, or authorizations of a relevant Regulatory Authority (including price approvals) necessary for the Development, Manufacture and/or Commercialization of such Covered Product in a particular country or jurisdiction.  For the avoidance of doubt, Regulatory Approval in the United States shall be deemed to occur upon approval of the applicable NDA (as defined above) in the United States, and shall not be construed to require a determination or approval of reimbursements of any type.

 

1.22                        “Territory” means all countries listed in Schedule 2 hereto.

 

1.23                        “Third Party” means any Person other than Marinus or NovaMedica.

 

1.24                        “Third Party Agreements” shall have the meaning set forth in Section 4.7.1.

 

1.25                        Interpretation.  The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  Unless specified to the contrary, references to Articles, Sections, or Schedules mean the particular Articles, Sections or Schedules to this Agreement and references to this Agreement include all Schedules hereto.  Unless context otherwise clearly requires, whenever used in this Agreement:  (i) “include” or “including” shall be construed as if followed by the words “but not limited to” or “without limitation” or words of similar import; (ii) the word “or” shall be construed as the inclusive meaning identified with the phrase “and/or;” (iii) provisions that require that a Party or the Parties to “agree,” “consent” or “approve” or the like shall require that such agreement, consent, or approval be specific and in writing, whether by written agreement, letter, written approval of minutes or otherwise; and (iv) references to any specific Law or article, section, or other division thereof shall be deemed to include then-current amendments thereto or any replacement Law thereof.  This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

 

In this Agreement, unless the context requires otherwise:

 

(a)                                 the headings are included for convenience only and shall not affect the construction of this Agreement;

 

(b)                                 words denoting the singular shall include the plural and vice versa;

 

(c)                                  words denoting one gender shall include each gender and all genders;

 

(d)                                 the words “include” or “including” shall mean “include, without limitation” or “including, without limitation,” as the case may be, and the language following “include” or “including” shall not be deemed to set forth an exhaustive list; and

 

4











 

(e)                                  any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or reenacted.

 

(f)                                   any Capitalized Terms not specifically defined herein shall have the meaning set forth in the TTA.

 

The Schedules to this Agreement comprise part of and shall be construed in accordance with the terms of this Agreement.

 

2.                                      SCOPE OF THE COLLABORATION

 

2.1                               Collaboration Goals. Pursuant and subject to the terms of this Agreement, within the Field and the Territory, the Parties agree to collaborate in the Development and Commercialization of Covered Product each supporting the Joint Steering, Development and Commercialization Team activities as outlined in Section 3.  All other advice and assistance shall be mutually agreed by the Parties.  NovaMedica shall promptly reimburse Marinus for all Out-of-Pocket Expenses incurred by Marinus in performing its obligations under this Agreement according to its terms.

 

Notwithstanding anything in this Agreement to the contrary, NovaMedica shall be free to work alone or with Third Parties to research, develop, manufacture and/or commercialize any product that is not a Covered Product in or outside the Field in the Territory in accordance with the TTA, and Marinus shall be free to work alone or with Third Parties to research, develop, manufacture and/or commercialize any Covered Product outside the Territory and any and all products that are not a Covered Product anywhere in the world.  Consistent with the TTA, Marinus shall have no obligation to perform any clinical trials in the Territory, except to the extent expressly agreed in writing by the Parties.

 

2.2                               Assistance by Marinus.  In connection with NovaMedica’s Development and/or Commercialization of the Compound and/or any of the Covered Product in the Territory, and in furtherance of such efforts, the Parties agree to form the committees specified in Section 2 of this Agreement to oversee the Development and Commercialization of the Covered Products in the Territory.

 

3.                                      MANAGEMENT OF COLLABORATION

 

3.1                               Joint Steering Committee.  Promptly after the Effective Date, the Parties shall establish a Joint Steering Committee (“JSC”) to oversee Development of Covered Products until the First Commercial Sale of a Covered Product in the Territory, unless otherwise agreed in writing by Marinus and NovaMedica.  The JSC will be comprised of an equal number of members appointed by NovaMedica and Marinus.  The JSC shall oversee the Development of Covered Products in the Field in the Territory by NovaMedica and its Permitted Transferees (“Development Plan”).  All JSC decisions will be made by unanimous vote, with the JSC representatives of Marinus collectively having one vote and the JSC representatives of NovaMedica collectively having one vote.  If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in Section 3.1.3 below.

 

5











 

3.1.1                     Chairmanship.  One JSC representative from a Party shall chair the JSC (the “Chairperson”) on a rotating annual calendar year basis, alternating between a representative from NovaMedica and a representative from Marinus, with the initial Chairperson to be from NovaMedica.  The Chairperson shall send notices and agendas for all JSC meetings to all JSC members and ensure review and approval of the minutes of each JSC meeting within thirty (30) calendar days of adjournment of a JSC meeting.

 

3.1.2                     Meetings.  Unless otherwise agreed in writing by NovaMedica and Marinus, the JSC will meet as needed upon request from at least one of the Parties to the then-current Chairperson.  At each meeting, the Parties shall provide updates on the status of their respective responsibilities.  Meetings may be held by teleconference, videoconference or in person, as mutually agreed upon by the Parties.  At each meeting, a secretary shall by appointed by the Chairperson to record meeting minutes.  Within ten (10) calendar days after a meeting, the Chairperson shall circulate draft minutes to the Parties for review, comment and distribution, in order to finalize the minutes within thirty (30) calendar days of such meeting.

 

3.1.3                     Dispute Resolution.  If a dispute arises in connection with the Development Plan, Commercialization of the Covered Product in the Field and in the Territory or any other issue addressed by the JSC, the JSC shall confer immediately and use Commercially Reasonable Efforts to resolve the dispute or issue within ten (10) calendar days of their initial conference.  No such dispute or issue shall be considered resolved until the JSC has unanimously agreed to the resolution; provided, however, that if the JSC does not reach consensus, within a thirty (30) calendar day period, the resolution of the dispute or issue if it relates to Development shall be made by the JSC representatives of Marinus or if it relates to Commercialization in the Territory shall be made by the JSC Representative of NovaMedica unless such resolution in the opinion of any member of the JSC would be reasonably expected to be adverse to, materially conflict with, or interfere with the regulatory approval, manufacture, marketing authorization or marketing efforts for Covered Products outside of the Territory (in the case of Marinus) or inside the Territory (in the case of NovaMedica), in which case such dispute will be escalated and otherwise handled in accordance with Section 12 of this Agreement.

 

3.2                               Joint Development Committee.  Promptly after the Effective Date, the Parties shall establish a Joint Development Committee (“JDC”), which shall continue in existence during the term of this Agreement for so long as NovaMedica (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory.  All day-to-day Development work shall be conducted under the direction of the JDC, which shall be comprised of an equal number of representatives from NovaMedica and Marinus.  All JDC decisions will be made by unanimous vote.  The JDC will be responsible for drafting the Development Plan for submission to the JSC, coordinating amendments to the Development Plan in respect of a Covered Product for use in the Field in the Territory, overseeing compliance with all safety requirements regarding the Covered Product in the Field and in the Territory for overseeing such Development work, and for making operational decisions related to such Development work.  Notwithstanding anything to the contrary set forth in this Agreement, NovaMedica and its Permitted Transferees shall bear full responsibility for complying with all safety and other regulatory requirements, laws and regulations regarding the Development of the Covered Product in the Field and in the Territory.

 

6











 

3.2.1                     Chairmanship.  One JDC representative from a Party shall chair the JDC (the “Chairperson”) on a rotating annual calendar year basis, alternating between a representative from NovaMedica and a representative from Marinus, with the initial Chairperson to be from Marinus.  The Chairperson shall send notices and agendas for all JDC meetings to all JDC members and ensure review and approval of the minutes of each JDC meeting within thirty (30) calendar days of adjournment of a JSC meeting.

 

3.2.2                     Meetings.  The JDC will meet as needed upon request from at least one of the Parties to the then-current Chairperson in accordance with a schedule to be established by the JDC from time to time.  At each meeting, the Parties shall provide updates on the status of their respective responsibilities.  Meetings may be held by teleconference, videoconference or in person, as mutually agreed upon by the Parties.  At each meeting, a secretary shall by appointed by the Chairperson to record meeting minutes.  Within ten (10) calendar days after a meeting, the Chairperson shall circulate draft minutes to the Parties for review, comment and distribution, in order to finalize the minutes within thirty (30) calendar days of such meeting.

 

3.2.3                     Dispute Resolution.  If a dispute arises in connection with the Development Plan or Development of the Covered Products or any other issue addressed by the JDC, the JDC shall confer immediately and use Commercially Reasonable Efforts to resolve the dispute or issue within ten (10) calendar days of their initial conference.  No such dispute or issue shall be considered resolved until the JDC has unanimously agreed to the resolution; provided, however, that if the JDC does not reach consensus, within a thirty (30) calendar day period, the resolution of the dispute or issue shall be made by the JSC representatives of Marinus unless such resolution in the opinion of any member of the JSC would be reasonably expected to be adverse to, materially conflict with the Development or regulatory approval for Covered Products in the Territory, in which case such dispute will be handled in accordance with Section 12 of this Agreement.

 

3.3                               Joint Commercialization Committee. Promptly after the Effective Date, the Parties shall establish a Joint Commercial Committee (“JCC”) which shall remain in existence during the term of this Agreement for so long as NovaMedica (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work and supply chain audit procedures shall be conducted under the direction of the JCC.  The JCC shall be comprised of an equal number of representatives from the NovaMedica and Marinus.  All JCC decisions will be made by unanimous vote.  Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program.  Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory.  The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunder.

 

3.3.1                     Chairmanship.  One JCC representative from a Party shall chair the JCC (the “Chairperson”) on a rotating annual calendar year basis, alternating between a representative from NovaMedica and a representative from Marinus, with the initial Chairperson

 

7











 

to be from NovaMedica.  The Chairperson shall send notices and agendas for all JCC meetings to all JCC members and ensure review and approval of the minutes of each JCC meeting within thirty (30) calendar days of adjournment of a JSC meeting.

 

3.3.2                     Meetings.  The JCC will meet as needed upon request from at least one of the Parties to the then-current Chairperson, in accordance with a schedule to be established by the JDC from time to time.  At each meeting, the Parties shall provide updates on the status of their respective responsibilities.  Meetings may be held by teleconference, videoconference or in person, as mutually agreed upon by the Parties.  At each meeting, a secretary shall by appointed by the Chairperson to record meeting minutes.  Within ten (10) calendar days after a meeting, the Chairperson shall circulate draft minutes to the Parties for review, comment and distribution, in order to finalize the minutes within thirty (30) calendar days of such meeting.

 

3.3.3                     Dispute Resolution.  If a dispute arises in connection with the Commercialization of the Covered Products or any other issue addressed by the JCC, the JCC shall confer immediately and use Commercially Reasonable Efforts to resolve the dispute or issue within ten (10) calendar days of their initial conference.  No such dispute or issue shall be considered resolved until the JCC has unanimously agreed to the resolution; provided, however, that if the JCC does not reach consensus, within a thirty (30) calendar day period, the resolution of the dispute or issue shall be made by the JCC representatives of NovaMedica unless such resolution in the opinion of any member of the JSC would be reasonably expected to be adverse to, materially conflict with, or interfere with the regulatory approval, manufacture, marketing authorization or marketing efforts for Covered Products outside of the Territory, in which case such dispute will be handled in accordance with Section 12 of this Agreement.

 

4.                                      DEVELOPMENT

 

4.1                               Development Efforts.  Through the JDC, Marinus and NovaMedica each agree to use Commercially Reasonable Efforts to collaborate with each other in the Development of the Covered Products in the Field in the Territory in accordance with this Agreement.

 

4.2                               Development Plan and Marinus’s Assistance.

 

4.2.1                     Initial Development Plan.  Initial Development Plan shall be prepared by the JDC, which shall be reasonably acceptable to Marinus.

 

4.2.2                     The Development Plan shall have the following goals:

 

(a)                                 the Development of the Covered Products specified in the Development Plan in accordance with all safety and other regulations as required to obtain Regulatory Approval in each country within the Territory as promptly as commercially and technically practicable, or as otherwise deemed appropriate by the JSC;

 

(b)                                 knowledge transfer and support by Marinus to NovaMedica and support to initiate or continue Development of, or in seeking Regulatory Approvals for, or to Commercialize the Covered Products in the Territory, by participation in the JDC; and

 

8











 

(c)                                  the identification, selection and co-development of additional products if appropriate.

 

4.2.3                     Assistance of Marinus. Consistent with its responsibilities under this Agreement, the TTA and the Development Plan, and subject in all respects to the terms and provisions of the TTA, as recognized by and stated in Section 13.12 hereof, Marinus shall:

 

(a)                                 the formation and transfer to NovaMedica of the information and capabilities necessary to Manufacture and supply Clinical Supplies and Commercial Supplies of the Covered Products, for such Development and Commercialization.

 

(b)                                 transfer to NovaMedica all Know-how, including but not limited to preclinical data, assays and associated materials, protocols and procedures, provided that, the initial transfer of Know-how from Marinus to NovaMedica shall include, but shall not be limited to, all manufacturing Know-how, reasonable quantities of the Covered Product and/or Compound for research, Development and Manufacturing scale-up work, all existing preclinical data, regulatory filings, and all existing clinical trial protocols and data;

 

(c)                                  make available to NovaMedica copies of any and all documentation in possession of Marinus related to the Covered Products and/or Compound, including but not limited to research data and reports, regulatory materials and correspondence (including INDs and NDAs in U.S.), clinical and preclinical data (including all raw data), chemistry, manufacturing and controls (CMC) data, relevant to conducting clinical studies and obtaining Regulatory Approval in the Field in the Territory (collectively, the “Clinical Data”), and NovaMedica shall have the right to use the Clinical Data solely in connection with, and as necessary for, the Development and Commercialization of the Covered Products in the Field and in the Territory.  NovaMedica and any Permitted Transferee shall be entitled at no cost to access, use, and reference the data and results from any Clinical Trial conducted by Marinus of a Covered Product in any Indication for their own Regulatory Approval, Development, and Commercialization purposes in the Field in the Territory;

 

(d)                                 provide reasonable scientific and technical explanations and advice that may reasonably be required by NovaMedica, relating to the Development and Commercialization of the Covered Product;

 

(e)                                  provide reasonable consultation with NovaMedica (and NovaMedica shall reimburse for Out-of-Pocket Expenses) in the preparation of and filing of any IND, IND amendment, or NDA with respect to any Covered Product in the Field and in the Territory.  Such assistance shall include, in particular, Company (or its Affiliate, successor, or licensee outside of the Territory) providing NovaMedica, to the extent an electronic copy is available or in possession of Company,  with a complete electronic copy of all relevant documentation submitted to the FDA or EMA in respect of any Clinical Trial for any Covered Product and/or Compound that would be necessary or useful to NovaMedica in preparing its own IND for a particular Covered Product for use in the Territory, and, to the extent necessary or useful, to allow NovaMedica to cross-reference any such IND, IND amendment, or NDA held by Company (or its Affiliate, successor, or licensee outside of the Territory); and

 

9









 

(f)                                   perform such other obligations set forth in this Agreement and the TTA.

 

4.2.4                     Reimbursement of Out-of-Pocket Expenses.  NovaMedica shall promptly reimburse Marinus for all Out-of Pocket Expenses incurred by Marinus in performing its obligations under this Agreement with exception obligations related to Marinus participation in JSC, JDC and JCC.

 

4.2.5                     Responsibilities of NovaMedica.  With coordination of the JSC, JDC or JCC, if applicable, NovaMedica shall:

 

(a)                                 at its sole cost and expense and using Commercially Reasonable Efforts, be responsible for Development conducting by NovaMedica of Covered Products in the Field and in the Territory in accordance with the Development Plan approved by the JSC;

 

(b)                                 be responsible for the preparation and filing at its sole cost and expense of any applications to register or obtain the Regulatory Approvals for the Covered Products in the Field in the Territory;

 

(c)                                  be responsible at its sole cost and expense for the performance of all activities and undertakings as may be required by any Regulatory Authorities to register or obtain the Regulatory Approval in the Field in the Territory for its own purposes;

 

(d)                                 at its sole cost and expense, be responsible for the Commercialization of the Covered Products in the Field in the Territory, including all sales and marketing activities, in the Field in the Territory;

 

(e)                                  following receipt of Regulatory Approval, be responsible at its sole cost and expense for the maintenance and updating of all Regulatory Approvals as may be required by any Regulatory Authorities, including any post approval studies required by any Regulatory Authorities and pharmacovigilance;

 

(f)                                   perform such other obligations contemplated by this Agreement and the TTA;

 

(g)                                  in cases specified in the TTA, reimburse Marinus all Out-of-Pocket expenses incurred by Marinus in performing its obligations hereunder; and

 

(h)                                 such other activities requested by the JSC, JDC or JCC.

 

4.3                               Clinical Trials in the Territory.  NovaMedica, itself or through one or more Third Parties selected by NovaMedica, shall have the sole authority and the exclusive right to conduct, in the Territory, all Clinical Trials and non-clinical studies NovaMedica believes appropriate to obtain Regulatory Approvals for the Covered Product in the Territory, subject to, and in accordance with the provisions of the TTA, including, but not limited to, Section 2.1(c) thereof.  Marinus shall use Commercially Reasonable Efforts to include sites in the Russian Federation in its Phase IIb Clinical Trial for its first Indication of the Covered Product in order to obtain a Regulatory Approval of such Covered Product outside the Territory and conduct such

 

10











 

Clinical Trial at its own costs.  All clinical data and reports related to Clinical Trials conducted by NovaMedica for the Covered Products in the Territory shall be owned by NovaMedica, and NovaMedica shall have full use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products, and NovaMedica shall provide Marinus with all such clinical data and reports for use by Marinus in a timely manner, as provided herein and in the TTA.  All clinical data and reports related to Clinical Trials conducted by Marinus for the Covered Products in the Territory shall be owned by Marinus, and Marinus shall provide NovaMedica with all such clinical data and reports for NovaMedica’s use, for any purpose consistent with this Agreement, of all such data and reports related to Clinical Trials for the Covered Products in the Territory.

 

4.4                               Clinical Supplies.  NovaMedica will have the right to purchase Clinical Supplies of the Covered Products and/or Compound in accordance with Section 3.5(c) of the TTA.

 

4.5                               Drug Approval Applications. NovaMedica shall be entitled to file Drug Approval Applications and seek Regulatory Approvals for the Covered Products in the Territory, provided that such filing shall be subject to the oversight of the JDC. Prior to submitting any clinical trial application or Drug Approval Application, the Parties, through the JDC, shall consult regarding the preparation of such filings, their content and scope. NovaMedica shall own all regulatory submissions, including all clinical trial applications, Drug Approval Applications and associated government licenses, approvals, and certificates for the Covered Products and/or Compound in the Territory.

 

4.6                               Regulatory Meetings and Communications.

 

4.6.1                     Upon agreement by the JSC, Marinus will participate in substantive discussions around and meetings with Regulatory Authorities in the Territory which relate to the Covered Products and/or Compound, including, but not limited to, with respect to any Drug Approval Applications.

 

4.6.2                     The JDC shall develop processes and procedures for the conduct and reporting to the Parties of telephone communications and written correspondence with Regulatory Authorities in the Territory related to the Covered Products and/or Compound.

 

4.6.3                     Within sixty (60) days after the Effective Date, the Parties’ respective regulatory affairs or other applicable departments, including the members of the JDC with regulatory and drug safety expertise, shall meet and agree upon processes and procedures to recommend to the JDC for sharing information needed to support each Party’s respective regulatory responsibilities, including without limitation, development of appropriate safety databases relating to Covered Products.  The processes and procedures adopted by the JDC under this Section for sharing of information and adverse event reporting shall be consistent with Section 8.

 

4.6.4                     The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of a Party’s site and facilities related to the Development of the Covered Products in the Territory, and each Party shall at a minimum be

 

11











 

given the opportunity to attend the summary, or wrap up, meeting related to the Covered Products with such Regulatory Authority at the conclusion of such site inspection.

 

5.                                      COMMERCIALIZATION

 

5.1                               Product Trademarks. The Covered Products shall be sold in the Territory only under the NovaMedica TradeMarks (the “Product Trademarks”). The term “Product Trademarks” shall also include any service marks for use in connection with services related to the Covered Products. In the event of a Third Party challenge of NovaMedica’s right to commercialize the Covered Products under Product Trademarks, the JSC shall consider the grounds for such challenge and recommend to the JCC a course of action in the affected market based on an assessment of the legal merits of such Third Party claim.

 

5.2                               Commercial Supplies.  Commercial Supplies of the Covered Product shall be governed by Sections 3.5(d) and (e) of the TTA.

 

5.3                               Recalls. Decisions with respect to recalls, withdrawals or corrections of the Covered Products in the Territory related to manufacturing or product quality issues shall be handled in accordance with the respective Supply Agreements. The JSC shall have decision-making authority with respect to issuing all recall, market withdrawal or correction of any the Covered Products in the Territory related to safety issues. Each Party shall delegate its appropriate executive officers in their respective regulatory departments who shall develop appropriate standard operating procedures with respect to such recalls at the time of commercialization. To the extent regulatory timeframes or public safety considerations require immediate action, a telephone conference of the JSC’s designees under this Section shall be called within the required timeframe to consider the action and make a decision. Each Party shall notify the other Party promptly (and in any event within twenty-four (24) hours of receipt of written notice) if the Covered Product is alleged or proven to be the subject of a recall, market withdrawal or correction in any country in the Territory. Marinus will make available to NovaMedica, upon request, all of the other Party’s pertinent records that NovaMedica may reasonably request to assist it in effecting any recall or market withdrawals.

 

6.                                      INTELLECTUAL PROPERTY.  The invention, ownership, development, prosecution, maintenance and enforcement of, and all other matters relating to, the Intellectual Property of the respective Parties shall be governed by the applicable terms and provisions of the TTA, and such terms and provisions are incorporated by reference into this Agreement.

 

7.                                      INFORMATION AND ADVERSE DRUG EVENTS AND REPORTS

 

7.1                               Information. Marinus and NovaMedica shall disclose and make available to each other in a timely manner all non-clinical, preclinical, clinical, regulatory, commercial and other information concerning the Covered Products and/or Compound and constituting Know-how, known by Marinus and NovaMedica at any time during the Term of this Agreement. Each Party will use Commercially Reasonable Efforts to disclose to the other Party all significant information related to the Covered Products and/or Compound and Development activity inside and outside of the Territory promptly after it is learned or its significance is appreciated.

 

12











 

Notwithstanding the foregoing, neither Party shall be obligated to disclose to the other Party confidential information about its products other than the Covered Products and/or Compound.

 

7.2                               Compliance. Each Party shall maintain a record of all non-medical and medical product-related reports it receives with respect to any Covered product and/or Compound. Each Party shall notify the other Party of any report received by it in sufficient detail and in accordance with the timeframes and procedures for reporting established by the JSC, and in any event in sufficient time to allow the Party that holds the applicable regulatory filing to comply with any and all regulatory requirements imposed upon it in any country. The Party that holds the applicable regulatory filing in a particular country shall investigate and respond to all such reports in such country with respect to any Covered Product as soon as reasonably practicable in accordance with regulatory requirements. All such responses shall be made in accordance with the procedures established by the JSC. The Party responsible for responding to such report shall promptly provide the other Party a copy of any such response.

 

7.3                               Adverse Drug Events. Each Party shall be responsible for the safety surveillance and pharmacovigilance regulatory obligations with respect to the Covered Product in those territories where it is the sponsor of non-clinical or clinical development,. The Parties agree to provide each other with Adverse Event information and product complaint information relating to Covered Products as compiled and prepared by the Parties in the normal course of business in connection with the Development, Commercialization or sale of the Covered Products, within time frames consistent with reporting obligations under applicable Law and regulatory requirements.  All reports, updates, Adverse Events, product complaint and other information provided by one Party to the other Party under this Agreement (including under this Section 7.3), shall be considered Confidential Information of the disclosing Party, subject to the terms of Section 8 hereof it being understood that the FDA or other applicable Regulatory Authority may publish information relating to Adverse Events on its website. The Parties agree that the groups responsible for the safety surveillance and pharmacovigilance of the Covered Product at each company shall meet at a mutually agreed upon time following the Effective Date to develop detailed procedures regarding the format, timing, and content of the safety information to be exchanged between the Parties, and shall meet periodically thereafter to update the procedures.

 

7.4                               Pharmacovigilance. The Parties agree that Marinus and NovaMedica will, within one hundred eighty (180) days after the date of the first Regulatory Approval in the Territory, conclude a Pharmacovigilance Agreement substantially in the form as provided in Schedule 4.6 to the TTA.

 

8.                                      TREATMENT OF CONFIDENTIAL INFORMATION

 

8.1                               Confidentiality; Exceptions.  Except to the extent authorized by this Agreement or otherwise agreed in writing, the Parties agree that the receiving Party (the “Receiving Party”) shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement, Confidential Information in any form (written, oral, photographic, electronic, magnetic, or otherwise) which is disclosed to it by the other Party (the “Disclosing Party”) or otherwise received or accessed by a Receiving Party in

 

13











 

the course of performing its obligations or exercising its rights under this Agreement, except to the extent that it can be established by the Receiving Party that such Confidential Information:

 

(a)                                 was in the lawful knowledge and possession of the Receiving Party prior to the time it was disclosed to, or learned by, the Receiving Party, or was otherwise developed independently by the Receiving Party, as evidenced by written records kept in the ordinary course of business, or other documentary proof of actual use by the Receiving Party;

 

(b)                                 was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

 

(c)                                  became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; or

 

(d)                                 was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others.

 

8.2                               Authorized Disclosure.  Except as expressly provided otherwise in this Agreement, a Receiving Party may use and disclose Confidential Information of the Disclosing Party as follows:  (a) in connection with the performance of its obligations or exercise of rights granted or reserved in this Agreement (including the rights to Develop and Commercialize the Covered Products); (b) to the extent such disclosure is reasonably necessary in filing or prosecuting patent, copyright and trademark applications, prosecuting or defending litigation, complying with applicable governmental regulations, obtaining regulatory approval, conducting Development, Commercialization, Clinical Trial Investigations, marketing Covered Products, or otherwise required by Law; or (c) to the extent mutually agreed to in writing by the Parties; provided, however, that if a Receiving Party is required in litigation or by Law or regulation to make any such disclosure of a Disclosing Party’s Confidential Information it shall give reasonable advance notice to the Disclosing Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, shall use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; further provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives the Confidential Information from the Receiving Party pursuant to this Section 8.2 to treat such Confidential Information as required under this Section 8.2.  In addition, a Receiving Party may disclose Confidential Information of the Disclosing Party to any of its Affiliates and Permitted Transferees, or in connection with due diligence investigations by or on behalf of a Third Party in connection with a potential license, collaboration, investment, merger, or acquisition with or by such Third Party, and, in the case of Marinus, to Third Parties in connection with due diligence investigations by or on behalf of a Third Party in connection with a potential license, collaboration, investment or other financing, merger, or acquisition with or by such Third Party; provided, however, in each of the foregoing cases, that such Third Party reasonably needs to have access to such Confidential Information agrees to be bound by reasonable terms of confidentiality and non-use at least as stringent as those set forth in this Article 8, to limit such disclosure to only personnel having a need to know such information, and to return or certify to the Receiving Party as to the destruction of such

 

14











 

Confidential Information promptly after completing the due diligence investigation, negotiation, or transaction, as the case may be.

 

8.3                               Disclosure of Agreement.  No Party shall issue any press release or other public disclosure regarding this Agreement or the Parties’ activities hereunder, or any results or data arising hereunder, except with all the other Party’s prior written consent.  Except to the extent required by Law or as otherwise permitted in accordance with this Section 8.3, neither Party shall make any public announcements concerning this Agreement or the subject matter hereof without the prior express written consent of the other, which shall not be unreasonably withheld, conditioned or delayed.  Notwithstanding the foregoing, to the extent information regarding this Agreement has already been publicly disclosed other than through any act or omission of a Party in breach of this Agreement, a Party may subsequently disclose the same information to the public without the consent of the other Party.  Each Party shall be permitted to disclose the terms of this Agreement, in each case under appropriate confidentiality provisions that are no stringent to those of this Agreement, to any actual or potential acquirers, merger partners, financing sources and professional advisors.

 

8.4                               Remedies.  Each Party shall be entitled to seek, in addition to any other right or remedy it may have, at law or in equity, a temporary injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Section 8.

 

9.                                      REPRESENTATIONS, WARRANTIES AND COVENANTS

 

9.1                               Representations, Warranties and Covenants.  Each Party hereby represents, warrants and covenants to the other Party as of the Effective Date, as follows:

 

9.1.1                     Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement.  This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.

 

9.1.2                     Such Party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement such Party would violate, any of the intellectual property rights of any Person.

 

9.1.3                     All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations under this Agreement have been obtained (other than such consents, approvals and authorizations that the Parties will obtain in the course of performing their obligations under this Agreement).

 

15











 

9.1.4                     The execution and delivery of this Agreement the performance of such Party’s obligations hereunder (i) do not conflict with or violate in any material way any requirement of applicable Law, (ii) do not conflict with or violate any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Party, and (iii) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.

 

10.                               INDEMNIFICATION

 

10.1                        Indemnification by NovaMedica. NovaMedica shall indemnify, defend, and hold Marinus and its Affiliates, and each of their respective employees, officers, directors, and agents (individually or collectively, the “Marinus Indemnitee(s)”) harmless from and against any and all liability, damage, loss, cost, or expense (including reasonable attorneys’ fees) resulting from Third Party claims against Marinus Indemnitee(s) arising out of or resulting from (a) any breach by NovaMedica or Permitted Transferee of any of the terms or provisions of this Agreement; (b) any breach of the representations, warranties, or covenants made by NovaMedica; (c) willful misconduct or negligence of NovaMedica, Permitted Transferee or any subcontractors or sublicensees; and (d) any act or omission of NovaMedica or any of its Affiliates, Permitted Transferees or their respective employees, Affiliates, agents or subcontractors in connection with the Development, Manufacturing, Commercialization, including but not limited to product liability claims; provided, however, that such obligations pursuant to this Section 10.1 shall not apply to the extent such claim (i) arise out of breach by the Marinus of its representations, warranties, or covenants set forth in Section 9, above; or (ii) are based on actions taken or omitted to be taken by Marinus in breach of its obligations under this Agreement; or (iii) result from the negligence or willful misconduct of any of the Marinus Indemnitee(s).

 

10.2                        Indemnification by Marinus. Marinus shall indemnify, defend, and hold each NovaMedica and any Permitted Transferee, and each of their respective agents, employees, officers, and directors (individually or collectively, the “NovaMedica Indemnitee(s)”), harmless from and against any and all from and against any and all liability, damage, loss, cost, or expense (including reasonable attorneys’ fees) resulting from Third Party claims against NovaMedica Indemnitee(s) arising out of or resulting from any (a) breach by Marinus of any of the terms or provisions of this Agreement; (b) any breach of the representations, warranties, or covenants made by Marinus; or (c) willful misconduct or negligence of Marinus or any of its Affiliates; (d) any act or omission of Marinus or any of its Affiliates, sublicenses, or their respective employees, Affiliates, agents or subcontractors in connection with the Development, Manufacturing, Commercialization, including but not limited to product liability claims; provided, however, that such obligations pursuant to this Section 10.2 shall not apply to the extent such Third Party claim (i) arises out of breach by NovaMedica of its representations, warranties, or covenants set forth in Section 9, above; or (ii) are based on actions taken or omitted to be taken by such NovaMedica in breach of its obligations under this Agreement; or (iii) result from the negligence or willful misconduct of any of NovaMedica Indemnitee(s).

 

10.3                        No Consequential Damages. EXCEPT FOR LIABILITY FOR BREACH OF SECTION 8, IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES, ASSIGNEES, LICENSEES, OR SUCCESSORS) BE LIABLE TO THE OTHER PARTY (OR

 

16











 

ANY OF THE OTHER PARTY’S AFFILIATES, ASSIGNEES, LICENSEES, OR SUCCESSORS) FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY BREACH THEREOF; PROVIDED, HOWEVER, THAT THIS SECTION 10.3 SHALL NOT BE CONSTRUED TO LIMIT EITHER PARTY’S INDEMNIFICATION OBLIGATIONS WITH RESPECT TO CLAIMS UNDER SECTION 10.1 OR 10.2, ABOVE.

 

10.4                        Notification of Claims; Conditions to Indemnification Obligations.  As a condition to a Party’s (or, as the case may be, a NovaMedica Indemnitee’s or a the Marinus Indemnitee’s) right to receive indemnification under this Section 10, it shall (a) promptly notify the other party as soon as it becomes aware of any Third Party claim or suit for which indemnification may be sought hereunder, (b) reasonably cooperate, and make Commercially Reasonable Efforts to cause the individual indemnitees to cooperate, with the indemnifying party in the defense, settlement, or compromise of such claim or suit, and (c) permit the indemnifying party to control the defense, settlement, or compromise of such claim or suit, including the right to select defense counsel; provided, however, the indemnified party shall have the right to join any defense with its own counsel at its own expense, or if the indemnifying party declines or fails to assert its intention to defend such action within sixty (60) days of receipt/sending of notice under this Section 10.4, then the indemnified party shall have the right, but not the obligation, to defend such action.  In no event, however, may the indemnifying party compromise or settle any claim or suit in a manner that admits fault or negligence on the part of the indemnified party (or any indemnitee) without the prior written consent of the indemnified party.  The indemnifying party shall have no liability under this Section 6 with respect to claims or suits settled or compromised by the indemnified party without the indemnifying party’s prior written consent.

 

11.                               TERM AND TERMINATION

 

11.1                        Term and Expiration.  The term of this Agreement (the “Term”) shall commence on the Effective Date and, unless earlier terminated as expressly provided in this Section 11, shall remain in full force and effect during three (3) years after the First Commercial Sale in the Territory.

 

11.2                        This Agreement shall automatically terminate upon termination of the TTA.

 

11.3                        Termination of the Agreement for Convenience. NovaMedica shall have the right, any time during the Term and at its convenience, to terminate this Agreement in its entirety upon ninety (90) calendar days prior written notice to Marinus.  Except as otherwise provided in this Agreement, Marinus shall have no right during the Term to revoke or unilaterally terminate the Agreement, in whole or in part.

 

17











 

11.4                        Effects of Termination.

 

(a)                                 Return of Confidential Information.  Upon termination, but not expiration, of this Agreement, each Party shall promptly return to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided, however, that each Party shall be entitled to retain one (1) copy of the other Party’s Confidential Information (subject to a continuing obligation of confidentiality) for the sole purpose of monitoring compliance with the terms of this Agreement, and all Confidential Information received by Marinus may continue to be used by it insofar as it relates to the Marinus or any Covered Product.

 

(b)                                 Accrued Obligations.  Termination of this Agreement for any reason shall not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination.

 

(c)                                  Non-Exclusive Remedy.  Termination of this Agreement by a Party shall be without prejudice to other remedies such Party may have at law or equity.

 

(d)                                 Survival.  The provisions of Sections 1, 4.2.4, 6, 8, 11.4, 12 and 13 shall survive termination of this Agreement. Furthermore, any other provision that by its nature is intended to survive expiration and/or termination of this Agreement shall survive.

 

12.                               DISPUTE RESOLUTION

 

The provisions of this Section 12 concern resolution of disputes between the Parties, which shall be resolved in accordance with dispute resolution procedures set forth below:

 

12.1                        Disputes.  The Parties recognize that disputes as to certain matters may from time to time arise during the Term that relate to either Party’s rights and/or obligations hereunder.  It is the objective of the Parties to establish procedures to facilitate the prompt resolution of disputes relating to or arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  In the event that the Parties are unable to resolve such dispute within thirty (30) days from the day that one Party had designated to the other an issue as a dispute, then either Party shall have the right to escalate such issue to senior management as set forth in Section 12.2, below.

 

12.2                        Escalation to Senior Representatives.  Either Party may, by written notice to the other Party, request that a dispute that remained unresolved for a period of thirty (30) days, as set forth in Section 12.1 above, be resolved by the Chief Executive Officer of NovaMedica (or such person’s designee) (the “NovaMedica Representative”) and the Chief Executive Officer of Marinus (or such person’s designee) (the “Marinus Representative”) (collectively, the “Representatives”) within sixty (60) days of the Representatives’ first consideration of such dispute, but in all cases within ninety (90) days after a Party’s written request for resolution by the Representatives.  Upon receipt of any such notice, a Party shall inform its Board of Directors thereof. If the Representatives cannot resolve such dispute within such ninety (90)-day period, either Party may proceed to enforce any and all of its rights with respect to such dispute in accordance with Section 12.3 or Section 12.4, below, as applicable.

 

18











 

12.3                        Arbitration.

 

(a)                                 Any dispute, controversy or claim arising out of, relating to or in connection with, this Agreement, including any dispute regarding the interpretation, validity or termination or the performance or breach of this Agreement, as well as any non-contractual obligation arising out of or in connection with it, which is not resolved by mutual agreement, above, shall be finally settled by binding arbitration under the Rules of the London Court of International Arbitration (the “LCIA”) then in effect.

 

(b)                                 The arbitration shall be conducted by arbitrators, of whom one shall be nominated by NovaMedica and one shall be nominated by Marinus. The two arbitrators so appointed shall nominate the third arbitrator, who shall act as chairman of the Arbitral Tribunal.  In the event that an arbitrator is not appointed pursuant to the foregoing provisions within the time period prescribed under the Rules of the LCIA or within the time-period agreed upon by the parties to the arbitration, upon request of either party to the arbitration, such arbitrator shall instead be appointed by the Court of the LCIA.

 

(c)                                  The Parties shall use good faith efforts to complete arbitration under this Section 8.3 within one hundred eighty (180) days following the initiation of such arbitration.  The Arbitral Tribunal shall permit full and complete discovery, both written and oral by deposition and shall establish reasonable additional procedures to facilitate and complete such arbitration within such one hundred eighty (180) day period. The place of arbitration will be London, England.  The language of the arbitration, and all proceedings thereunder, including all discovery (both written and oral) will be English.

 

(d)                                 By agreeing to arbitration, the Parties do not intend to deprive any court of competent jurisdiction of its ability to issue any form of provisional remedy, including but not limited to a preliminary injunction or attachment in aid of the arbitration, or order any interim or conservatory measure.  A request for such provisional remedy or interim or conservatory measure by a Party to a court or other government entity shall not be deemed a waiver of this agreement to arbitrate.

 

(e)                                  The award rendered by the Arbitral Tribunal, which shall cover which party shall bear the costs of the arbitration in accordance with subsection (f) below, shall be final and binding on the parties.  Judgment on the award may be entered in any court of competent jurisdiction.

 

(f)                                   The costs of such arbitration, including administrative and fees of the arbitrators comprising the arbitration panel, shall be shared equally by the Parties, and each Party shall bear its own expenses and attorney’s fees incurred in connection with the arbitration; provided, however, that the arbitration panel may direct that the costs and attorney fees paid by one party be reimbursed by the other party.  The arbitration panel shall consider the following factors in determining whether to award costs and attorney fees to be paid by one party to another party: (i) the conduct of the parties in the transactions or occurrences that gave rise to the dispute or claim, including any conduct of a party that was reckless, willful, malicious, in bad faith or illegal; (ii) the objective reasonableness of the claims and defenses asserted by a party; (iii) the extent to which an award of costs and attorney fees would deter future bad faith

 

19











 

claims or defenses; (iv) the objective reasonableness of the parties and the diligence of the parties and their attorneys during the proceedings; (v) the objective reasonableness of the parties and the diligence of the parties in pursuing settlement of the dispute; and (vi) such other factors as the arbitration panel may consider appropriate under the circumstances.

 

12.4                        Provisional Remedies.  Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief, pending resolution under Sections 12.2 or 12.3, above, as applicable, that may be necessary to protect the rights or property of that Party.  Seeking or obtaining such equitable or interim relief or provisional remedy in a court shall not be deemed a waiver of the agreement to arbitrate.  For clarity, any such equitable remedies shall be cumulative and not exclusive and are in addition to any other remedies that either Party may have under this Agreement or applicable Law.

 

12.5                        Remedies. In the event a Party is in breach of its obligations under this Agreement, and the breach is not remedied in accordance with the terms of this Agreement, the other Party shall be entitled to all remedies available in law or equity, consistent with the terms of this Agreement, including without limitation, collection of damages, injunctive relief, and specific performance.

 

13.                               MISCELLANEOUS

 

13.1                        Relationship of the Parties.  Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, joint venture, or other relationship between the Parties.

 

13.2                        Assignment.

 

(a)                                 Except as expressly provided herein, neither this Agreement nor any interest hereunder shall be assignable nor any other obligation delegable, by either Party without the prior written consent of the other Party (not to be unreasonably withheld or delayed).  Notwithstanding the foregoing, each Party shall have the right to assign this Agreement in whole without the consent of the other Party to (X) any Affiliate (Y) Permitted Transferee or (Y) a successor to substantially all of the business of the assigning Party to which this Agreement relates (“Successor”), whether by merger, sale of stock, sale of assets or similar transaction, operation of law, or otherwise; provided, however, that an Affiliate or Successor must accept all rights and obligations under this Agreement and the Ancillary Agreements.

 

(b)                                 Any permitted assignment under this Section 13.2 shall relieve the assigning Party of any and all of its responsibilities or obligations hereunder, provided that, as a condition of such assignment, the assignee agrees in writing to be bound by all obligations of the assigning Party hereunder.

 

(c)                                  This Agreement shall be binding upon the successors and permitted assigns of the Parties.

 

(d)                                 Any assignment not in accordance with this Section 13.2 shall be void.

 

20









 

13.3                        Performance by NovaMedica and Permitted Transferee.  Notwithstanding anything to the contrary in this Agreement, NovaMedica shall have the right to have any of its obligations hereunder performed, or its rights hereunder exercised, by, any of its Affiliates or Permitted Transferees, and the performance of such obligations by any such Affiliate(s) or Permitted Transferee(s) shall be deemed to be performance by NovaMedica and, provided that (a) any NovaMedica or Permitted Transferee that agrees to perform or exercise on NovaMedica behalf any of NovaMedica’s obligations or rights under this Agreement agrees that Marinus is an intended third party beneficiary of any such performance or exercise; (b) NovaMedica provides Marinus with a copy of such agreement between NovaMedica and the Permitted Transferee; and (c) thereafter NovaMedica shall continue to be responsible to Marinus for performance of such obligation(s) under this Agreement.

 

13.4                        Actions.  Each Party agrees to execute, acknowledge, and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

13.5                        Force Majeure.  Neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by acts of God, earthquake, riot, civil commotion, terrorism, war, strikes or other labor disputes, fire, flood, failure or delay of transportation, default by suppliers or unavailability of raw materials, governmental acts or restrictions or any other reason which is beyond the control of the respective Party.

 

13.6                        Amendments.  No waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in a writing referencing this Agreement and signed by a duly authorized officer of each Party.

 

13.7                        Captions.  The captions to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.

 

13.8                        Governing Law.  This Agreement shall be governed by and interpreted in accordance with the Laws of the State of New York, USA, excluding the application of any conflict of laws principles that would require application of the Law of another jurisdiction; provided, however, that matters of intellectual property law shall be determined in accordance with the national intellectual property laws relevant to the intellectual property at issue.

 

13.9                        Notices and Deliveries.  Any notice, request, approval, or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted, by facsimile (receipt verified), or by express courier service (signature required) to the Party to which it is directed at its address or facsimile number shown below or such other address or facsimile number as such Party shall have last given by notice to the other Party.

 

21











 

	
If to Company,   addressed to:
    
	
Marinus Pharmaceuticals, Inc.
    
	
142 Temple Street, Suite 205
    
	
New Haven, CT   06510 USA
    
	
Attention:   President and CEO
    
	
Facsimile:   203-3150565
    
	
 
    
	
With a copy to:
    
	
Duane Morris LLP
    
	
30 South 17th   Street
    
	
Philadelphia, PA   19103-4196
    
	
Attention:   Kathleen M. Shay
    
	
Facsimile: (215)   689-4382
    
	
 
    
	
If to NovaMedica,   addressed to:
    
	
NovaMedica, LLC
    
	
125047 bldg 29/22
    
	
1st Brestskaya   Street
    
	
Moscow
    
	
Russian   Federation
    
	
Attention: CEO of   LLC “D-Pharma”, Managing Company
    
	
Vladimir Gurdus
    
	
Facsimile:
    	
 
    	
 
    


 

13.10                 Waiver.  A waiver by either Party of any of the terms and conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any other term or condition hereof.  All rights, remedies, undertakings, obligations, and agreements contained in this Agreement shall be cumulative and none of them shall be in limitation of any other remedy, right, undertaking, obligation, or agreement of either Party.

 

13.11                 Severability.  When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable Law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable Law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.  The Parties shall make a good faith effort to replace the invalid or unenforceable provision with a valid one that in its economic effect is most consistent with the invalid or unenforceable provision.

 

13.12                 Transfer and Technology Agreement. The terms and conditions of the TTA are not changed, amended or modified through this Agreement and shall remain unchanged and in full force and effect. All rights, powers and privileges of the Parties under this Agreement are in addition to any rights, powers and privileges granted to the Parties by the TTA.

 

13.13                 Assumptions.  The terms and provisions in this Agreement have been negotiated and drafted on the assumption by the Parties that there are no laws or regulations in the Territory that will prevent or significantly hinder NovaMedica or Permitted Transferees or

 

22











 

Marinus from performing their obligations and realizing their benefits as set forth in this Agreement.  If this assumption ultimately proves to be untrue, the Parties will use good faith efforts to make such revisions as are reasonable and equitable to the Parties and are in compliance with the laws and regulations of the Territory.

 

13.14                 English as the Controlling Language for all Agreements.  All notices and other communications under this Agreement and any related agreements, including assignments, licenses, and/or sublicenses with NovaMedica and/or a Permitted Transferee, shall be in the English language.  NovaMedica shall, furthermore, require that any assignment, license, sublicense, or other agreement (i) having NovaMedica or a Permitted Transferee as a party and (ii) a complete and accurate copy of which is required by this Agreement to be provided a Party, shall be prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of that agreement.

 

13.15                 Counterparts.  This Agreement may be executed in one or more counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument.  An electronic or facsimile copy of this Agreement, including the signature pages, will be deemed an original.

 

[Remainder of page intentionally left blank]

 

23











 

IN WITNESS WHEREOF, each of the Parties have caused this Clinical Development and Collaboration Agreement to be executed by its duly authorized representative as of the Effective Date.

 

 

	
MARINUS   PHARMACEUTICALS, INC.
    	
 
    	
NOVAMEDICA,   LLC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Christopher M. Cashman
    	
 
    	
By: 
    	
/s/   Vladimir Gurdus
    
	
 
    	
 
    	
 
    
	
Name:   Christopher M. Cashman
    	
 
    	
Name:   Vladimir Gurdus
    
	
Title:   Chief Executive Officer
    	
 
    	
Title:   CEO of LLC “D-Pharma”
    
	
 
    	
 
    	
Managing   Company
    
					


 

24











 

Schedule 1-Compound

 

ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20-one), having the chemical structure:



 

25











 

Schedule 2 – Territory

 

	
CIS states:
    
	
 
    
	
1.
    	
Armenia
    
	
2.
    	
Azerbaijan
    
	
3.
    	
Belarus
    
	
4.
    	
Kazakhstan
    
	
5.
    	
Kyrgyzstan
    
	
6.
    	
Moldova
    
	
7.
    	
Russia
    
	
8.
    	
Tajikistan
    
	
9.
    	
Ukraine
    
	
10.
    	
Uzbekistan
    
	
 
    	
 
    
	
Non-CIS states:
    
	
 
    
	
11.
    	
Georgia
    
	
12.
    	
Turkmenistan
    


 

26