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IKARIA, INC.
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S-1
May 13, 4:03 PM ET
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IKARIA, INC. S-1
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1. DEFINITIONS AND INTERPRETATION
1.1 Definitions
(a) experience which is adverse, including what are commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product:
(i) occurring in the course of the use of a drug, biological product or device;
(ii) associated with, or observed in conjunction with product overdose, whether accidental or intentional;
(iii) associated with, or observed in conjunction with product abuse; and/or
(iv) associated with, or observed in conjunction with product withdrawal; and/or
(b) significant failure of expected pharmacological or biologic therapeutical action (except in clinical trials).
(a) exclusive license agreement dated 1 September 2003 between The Beth Israel Deaconess Medical Center, Inc., Yale University, Johns Hopkins University and University of Pittsburgh-of the Commonwealth System of Higher Education and AGA, which was assigned by AGA to INO-T under the relevant AGA Contracts Assignment Agreement; and/or
(b) license agreement between The Trustees of Columbia University in the City of New York and AGA dated December 18, 2002, which was assigned by AGA to INO-T under the relevant AGA Contracts Assignment Agreement.
(a) the whole of the European Union (as it may be constituted from time to time);
(b) France;
(c) Germany;
(d) Sweden; or
(e) the United Kingdom.
1.2 Interpretation:
(a) the definitions of terms in this Agreement shall apply equally to the singular and plural forms of the terms defined;
(b) any pronoun shall include the corresponding masculine, feminine and neuter forms;
(c) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”;
(d) the word “will” shall be construed to have the same meaning and effect as the word “shall”;
(e) any definition of or reference to any Contract or other record in this Agreement shall be construed as referring to such Contract or other record as from time to time amended, supplemented, restated or otherwise modified (subject to any applicable restrictions on such amendments, supplements or modifications);
(f) any reference in this Agreement to any Person shall be construed to include such Person’s successors and permitted assigns;
(g) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof;
(h) all references in this Agreement to Sections, Exhibits and Schedules shall be construed to refer to Sections of, and Exhibits and Schedules to, this Agreement; and
(i) the headings, captions and defined terms used in this Agreement are for convenience of reference only and are not to affect the construction of or to be taken into consideration in interpreting this Agreement.
2. TERM
3. SUPPLY OF SUPPLY PRODUCTS FOR LINDE TERRITORIES
4. NEW INDICATIONS FOR LINDE TERRITORIES
4.1 Development Activities
(a) INO-T shall keep AGA informed of the progress of INO-T Group’s development activities relating to New Indications.
(b) INO-T shall not unreasonably refuse to adapt INO-T Group’s plans for those development activities if AGA notifies INO-T that any adaptation would, in AGA’s reasonable opinion, improve the chances of obtaining Health Registrations for the New Indication in one or more of the Linde Territories, without adversely affecting the chances of obtaining such Health Registrations in the INO-T Territories. If requested by AGA, INO-T shall meet with AGA to discuss proposed adaptations. AGA shall pay INO-T’s reasonable costs associated with any such adaptation implemented by INO-T.
4.2 Health Registration Applications
(a) INO-T shall not, and shall cause the INO-T Group not to, object to the Linde Group applying for Health Registrations for New Indications in the Linde Territories.
(b) In respect of any New Indications for which the INO-T Group is in possession of, or has access to, data reasonably sufficient for obtaining, and intends to apply for, a Health Registration outside the Linde Territories, INO-T shall, except following a transfer pursuant to Section 4.2(c)(ii):
(i) give the Linde Group access to all data and documentation relating to the New Indication that are in the possession of, or otherwise accessible by, the INO-T Group;
(ii) ensure that all data and documentation that the INO-T Group possesses or has access to, that may be requested by any Regulatory Authority in the Linde Territories, are maintained in such a way that the Linde Group can promptly respond to such requests in an appropriate manner; and
(iii) if requested by AGA, at AGA’s cost, provide reasonable support and carry out such further studies in relation to those New Indications as are required for submissions to Regulatory Authorities in the Linde Territories.
(c) In the event that the INO-T Group decides that it no longer wishes to maintain data or documentation in relation to a New Indication, INO-T shall, no later than:
(i) [**] months prior to the cessation of that maintenance, notify AGA that it so wishes; and
(ii) [**] months prior to the cessation of that maintenance transfer to AGA, or a member of the Linde Group nominated by AGA, a copy of all data and originals of all documentation (together with the right for the Linde Group to use that data and documentation in any way whatsoever) that the INO-T Group possesses or has access to in relation to that New Indication, in a format reasonably requested by AGA.
4.3 Sales Related Payment
(a) Subject to Section 4.3(b) and the remainder of this Section 4.3(a), if the Linde Group obtains a Marketing Authorization for a New Indication and commences the sale of End Products for that New Indication, AGA shall pay INO-T an amount equal to [**] percent ([**]%) of the amount by which Gross Sales for the Quarter Year in question exceeded [**] euros (€[**]) (with the first Quarter Year in which the Linde Group sells End Products for that New Indication and Gross Sales exceed [**] euros (€[**]) being referred to as the First Measuring Year). Such amount shall:
(i) be due and payable on or before the earliest of March 31, June 30, September 30, or December 31 of the Year following the Quarter Year in question, with the first such payment due on March 31, June 30, September 30, or December 31 of the Year following the First Measuring Year (and, for the avoidance of doubt, relating to the First Measuring Year);
(ii) only be required to be paid in respect of the five consecutive Quarter Years commencing with the First Measuring Year (with the last payment due, if at all, on the earliest of March 31, June 30, September 30, or December 31 of the Year following such fifth consecutive Quarter Year); provided that if the Linde Group obtains a Marketing Authorization for any further New Indication during those five consecutive Quarter Years commencing with the First Measuring Year, then such amount shall be payable through the later of five consecutive Quarter Years commencing with the:
(A) First Measuring Year; and
(B) Quarter Year in which the Marketing Authorization for the further New Indication was obtained by the Linde Group; and
(iii) be paid in euros by wire transfer of immediately available funds to an account designated in writing by INO-T.
(b) The Sales Related Payment shall be reduced to the extent, that (if applicable) royalties are payable by all and any members of the Linde Group under Section 8 of the Viasys Settlement Agreement in relation to Gross Sales; provided that, such reduction shall not exceed [**] of the Sales Related Payment that would be due in relation to such Gross Sales absent any such royalties payable under Section 8 of the Viasys Settlement Agreement.
(c) From the date on which the first Sales Related Payment is due and payable under Section 4.3(a), the Parties acknowledge that all amounts payable by the Linde Group to the INO-T Group pursuant to the Existing ROW Agreements other than the Australian Agreement shall be reduced by [**] in accordance with the Existing ROW Amendment Agreement.
5. RIGHT OF FIRST REFUSAL FOR NEW ROW TERRITORIES
(a) INO-T shall not, and shall cause the INO-T Group not to, sell the End Products (whether for a use that is the subject of a Health Registration existing as at the Effective Date in any territory, or for a New Indication) to a third party distributor that is not a member of the INO-T Group or the Linde Group in any of the New ROW Territories unless the provisions of this Section 5 have been complied with.
(b) INO-T grants AGA, or a member of the Linde Group nominated by AGA, a right of first refusal (ROFR) to be appointed as the exclusive distributor of the End Products (for uses that are the subject of Health Registrations existing as at the date of this Agreement in any territory, and for New Indications) in the New ROW Territories on the following basis:
(i) INO-T shall provide written notice to AGA of its intention to appoint a third party distributor (that is not a member of the INO-T Group or the Linde Group) of the End Products in a country or countries (the Target Territory);
(ii) immediately following receipt of that notice by AGA, INO-T shall grant AGA, and/or the nominated member of the Linde Group, a [**] days’ period of exclusivity for negotiation of an exclusive distribution agreement for End Products in the Target Territory (the Exclusivity Period);
(iii) during the Exclusivity Period, AGA, and/or the nominated member of the Linde Group, and INO-T shall endeavor to enter into an exclusive distribution agreement for End Products in the Target Territory;
(iv) INO-T shall provide AGA with a written copy of the full principal terms on which INO-T wishes to enter into an exclusive distribution agreement, including regarding the term and termination of the agreement, its territorial scope, the exclusive rights granted, noncompetition obligations, payments (including royalties, costs of Products and profit sharing) and any minimum purchase obligations:
(A) within [**] days of the start of the Exclusivity Period; and
(B) on the [**] day (or, if that is not a Business Day, the next Business Day) following the start of the Exclusivity Period,
(v) if:
(A) INO-T and AGA, and/or the nominated member of the Linde Group, have not entered into such an exclusive distribution agreement by the end of the Exclusivity Period; or
(B) AGA, by written notice to INO-T, waives the ROFR contemplated by this Section 5 in respect of the Target Territory,
(vi) if such a distribution agreement with any other Person is:
(A) not entered into within such [**] days’ period; or
(B) entered into within such [**] days’ period and that agreement expires or is terminated,
(c) For the avoidance of doubt, if AGA elects not to exercise its ROFR to be appointed as the exclusive distributor of the End Products in a Target Territory pursuant to Section 5(b), and INO-T enters into an
agreement with a third party in accordance with Section 5(b), AGA shall not be entitled to any ROFR for New Indications in that Target Territory.
6. NEW DELIVERY DEVICES
6.1 Notice of New Delivery Devices
(a) INO-T shall from time to time provide AGA with details of its development program for new or successor delivery devices that are intended to replace INOvent (New Delivery Devices).
(b) No later than the date on which the INO-T Group commences the sale of the New Delivery Devices in an INO-T Territory, INO-T shall offer the Recipients the right to purchase the New Delivery Devices on a cost plus [**] percent ([**]%) basis under, subject to Section 6.1(c), the terms and conditions of this Agreement applicable to INOvents; for the avoidance of doubt, after such date, Recipients (in their absolute discretion) may choose to purchase INOvents (subject to the limitations set forth in Section 10.1(c)(ii)) and/or New Delivery Devices (subject to Section 6.1(c)).
(c) INO-T shall:
(i) consult with AGA (including via the Joint Committee), from time to time (as appropriate) and when requested by AGA, in relation to its program for the roll-out of New Delivery Devices;
(ii) take into account the requirements (including regarding quantity and delivery time) of the Recipients for New Delivery Devices;
(iii) use commercially reasonable efforts to enter into one or more Contracts pursuant to which one or more third parties shall supply to INO-T sufficient New Delivery Devices to enable INO-T to meet the requirements (including regarding quantity and delivery time) of the Recipients; and
(iv) in the event that it has complied with its obligations set out in Sections 6.1(c)(i) to 6.1(c)(iii) and is nevertheless unable to supply the Recipients with their requirements for New Delivery Devices, use commercially reasonable efforts to meet their requirements itself and, if requested by AGA, use commercially reasonable efforts to find an alternative supplier of New Delivery Devices in order that their requirements (including regarding quantity and delivery time) for New Delivery Devices can be met,
6.2 Regulatory Requirements for New Delivery Devices
7. COVOX
7.1 Health Registrations in Linde Territories
(a) INO-T shall not, and shall cause the INO-T Group not to, object to the Linde Group applying for, Health Registrations for Covox in the Linde Territories.
(b) If the INO-T Group is in possession of, or has access to, data reasonably sufficient for obtaining, and intends to apply for, a Health Registration for Covox outside the Linde Territories, INO-T shall, except following a transfer pursuant to Section 7.1(d)(ii):
(i) give the Linde Group access to all data and documentation relating to Covox that are in the possession of, or otherwise accessible by, the INO-T Group;
(ii) ensure that all data and documentation that the INO-T Group possesses or has access to, that may be requested by any Regulatory Authority in the Linde Territories, are maintained in such a way that the Linde Group can promptly respond to such requests in an appropriate manner; and
(iii) if requested by AGA, at AGA’s cost, provide reasonable support and carry out such further studies in relation to Covox as are required for submissions to Regulatory Authorities in the Linde Territories.
(c) INO-T shall make Covox available for purchase by the Recipients from the INO-T Group for the Linde Territories on, subject to Section 7.3, substantially the same terms and conditions as the Supply Products are supplied to the Recipients under this Agreement.
(d) In the event that the INO-T Group decides that it no longer wishes to maintain data or documentation in relation to Covox, INO-T shall, no later than:
(i) [**] months prior to the cessation of that maintenance, notify AGA that it so wishes; and
(ii) [**] months prior to the cessation of that maintenance transfer to AGA, or a member of the Linde Group nominated by AGA, a copy of all data and originals of all documentation (together with the right for the Linde Group to use that data and documentation in any way whatsoever) that the INO-T Group possesses or has access to in relation to Covox, in a format reasonably requested by AGA.
7.2 Marketing, Sales and Logistics in the Linde Territories
7.3 Royalties for sales in the Linde Territories
7.4 ROFR as Distributor in ROW
7.5 Milestones
8. NEW PRODUCTS AND NO DISSOLVED IN LIQUID
8.1 New Products
(a) INO-T shall notify AGA of New Products that the INO-T Group is developing, and keep AGA informed regarding the progress of clinical trials and the status of applications and proposed applications for Health Registrations for those New Products, for the purpose of discussing whether the Parties wish to pursue a commercial relationship for such New Products, provided that that notification shall be subject to the restrictions set out in Section 17.1.
(b) AGA shall notify INO-T of New Products that the Linde Group is developing, and keep INO-T informed regarding the progress of clinical trials and the status of applications and proposed applications for Health Registrations for those New Products, for the purpose of discussing whether the Parties wish to pursue a commercial relationship for such New Products, provided that that notification shall be subject to the restrictions set out in Section 17.1.
8.2 NO Dissolved in Liquid
(a) Until the date that is [**] months from the Effective Date, AGA shall not, and shall cause the Linde Group not to, negotiate or enter into, or attempt to negotiate or enter into, any Contract with Lars Gustafson of Sweden relating to a patent application made before the Effective Date concerning the medical use of NO dissolved in liquid. If INO-T does not enter into such a Contract with Mr. Gustafson within [**] months from the Effective Date:
(i) INO-T shall promptly provide AGA with an update concerning negotiations undertaken with Mr. Gustafson and AGA and INO-T will discuss in good faith the most effective way to conduct any further negotiations with Mr. Gustafson; and
(ii) in the event that INO-T has initiated Contract negotiations with Mr. Gustafson and reasonably believes that it will enter into such a Contract with Mr. Gustafson within a further [**] months, and so notifies AGA, AGA shall not, and shall cause the Linde Group not to, negotiate or enter into, or attempt to negotiate or enter into, any Contract with Mr. Gustafson during those further [**] months.
(b) For the avoidance of doubt, nothing in this Agreement shall prevent the Linde Group from negotiating and/or entering into such a Contract after the period specified in Section 8.2(a) and AGA shall not be subject to any obligations under Section 17.1 in relation to the subject-matter of that Contract.
(c) If the INO-T Group and/or the Linde Group enter into such a Contract with Mr. Gustafson, AGA and INO-T contemplate that they will enter into a further Contract with each other to provide for the mutual commercial benefit (including negotiating in good faith appropriate intellectual property licenses) of the Linde Group and the INO-T Group, pursuant to which the Linde Group would commercialize the subject-matter of Mr. Gustafson’s patent technology in the Linde Territories, and the INO-T Group would commercialize the subject-matter of Mr. Gustafson’s patent technology in the INO-T Territories.
9. COMPLIANCE AUDITS; GOVERNMENT INSPECTION
9.1 Compliance Audits
(a) Each Party (or its nominated representatives) shall have the right, during normal business hours and with reasonable prior notice, to visit any of the other Party’s (or the relevant members of that Party’s Group’s, or suppliers’) facilities utilized or to be utilized in the manufacture, storage, distribution and/or handling of the Supply Products (in respect of INO-T) or End Products (in respect of AGA), with or without cause, to inspect for compliance with requirements of Regulatory Authorities and Applicable Laws, including cGMPs, the Specifications and the Standards.
(b) The Parties’ respective quality assurance departments shall cooperate with each other, as necessary and useful, in any inspection conducted pursuant to this Agreement.
(c) INO-T shall permit AGA’s representatives to access systems, documents and records associated with the manufacture of the Supply Products, and allow them to make such copies (or provide them with electronic copies) as are reasonably necessary for the purpose of assessing compliance with requirements of Regulatory Authorities and Applicable Laws, including cGMPs, the Specifications and the Standards.
9.2 Regulatory Inspection
10. SUPPLY OF SUPPLY PRODUCTS
10.1 Supply
(a) INO-T may manufacture Bulk NO Gas for the Recipients at any FDA-approved facility, provided that INO-T shall provide AGA with at least [**] months’ written notice before commencing to supply Bulk NO Gas from any facility other than its Port Allen manufacturing plant located at Baton Rouge as at the date of this Agreement.
(b) The Linde Group shall not be obligated to purchase any minimum quantity of the Supply Products from INO-T.
(c) INO-T shall manufacture and supply those quantities of the Supply Products that the Recipients require for the Linde Territories, provided that INO-T shall not be required to supply:
(i) Bulk NO Gas to the Recipients in the event that INO-T:
(A) gives AGA at least [**] months’ written notice that it will cease to supply Bulk NO Gas in the INO-T Territories and so ceases; and
(B) uses commercially reasonable efforts to assist (in AGA’s absolute discretion):
(I) the Recipients to find, and transition to, an alternative supplier of Bulk NO Gas in order that their requirements (including regarding quantity and delivery time) for Bulk NO Gas can be met; and/or
(II) if AGA so requests, the Linde Group to develop operational facilities for the manufacture of Bulk NO Gas prior to the expiry of the [**] months’ period referred to in Section 10.1(c)(i)(A), including by promptly providing, and causing the INO-T Group promptly to provide, to the Linde Group all relevant training, know-how, data, documentation, and other assistance; and/or
(ii) any Supply Product other than Bulk NO Gas to the Recipients in the event that INO-T:
(A) gives AGA at least [**] written notice that it will cease to supply that Supply Product in the INO-T Territories and so ceases; and
(B) uses commercially reasonable efforts to assist the Recipients to find, and transition to, an alternative supplier of that Supply Product in order that their requirements (including regarding quantity and delivery time) for that Supply Product can be met.
(d) Without prejudice to Section 3 and the other provisions of Section 10 if because:
(i) of Force Majeure;
(ii) a Regulatory Authority takes any action the result of which is to prohibit the manufacture, sale or use or any similar action of any of the Products, or any materials contained in them, in the United States of America and/or the Linde Territories; or
(iii) of reasons (including a shortage of Supply Products) otherwise outside its control,
(e) AGA shall, and shall cause the Recipients to, purchase Supply Products from INO-T solely for medical use. In the event that any Recipient wishes to purchase Supply Products or other NO-related products from INO-T for non-medical uses, the Parties will discuss the possibility of INO-T supplying such Supply Products or other NO-related products to Recipients for non-medical uses. For the avoidance of doubt, nothing in this Agreement shall restrict the purchase by the Linde Group of Supply Products from a Person other than INO-T (including for non-medical use(s)).
10.2 Forecasts
(a) AGA shall provide to INO-T on or before the first day of each calendar quarter during the Term with a rolling [**] month forecast of the Recipients’ anticipated requirements for the Supply Products (the Forecast). Any forecast provided before the Effective Date shall be deemed not to be a binding commitment.
(b) The requirements specified for the first [**] months of each Forecast shall represent a binding commitment by AGA (or the relevant Recipient) to purchase and pay for the Supply Products specified in it. The last [**] months of the Forecast shall represent estimates and shall be non-binding.
10.3 Orders
(a) In respect of the requirements specified for the first [**] months of each Forecast, AGA (or the relevant Recipient) shall place binding purchase orders that shall set out the required quantity of the Supply Products, proposed delivery dates and shipping instructions for each shipment of the Supply Products. Binding purchase orders for the Supply Products shall be placed by AGA (or the relevant Recipient) in writing by the [**] day of each calendar month (or the next applicable business day) and supplemental binding purchase orders may be placed thereafter.
(b) INO-T shall provide AGA (or the relevant Recipient) with written confirmation of all purchase orders within [**] days of receipt. Confirmations shall set out the quantities ordered by AGA (or the relevant Recipient) and specify delivery dates for all quantities which shall be no later than [**] days from the date of the relevant purchase order.
(c) Subject to Section 10.1, INO-T shall supply to the Recipients quantities of the Supply Products for a given calendar quarter that are up to [**]% of AGA’s (or the relevant Recipient’s) most recent Forecast for that calendar quarter. INO-T shall use commercially reasonable efforts to supply excess quantities to the extent practicable.
10.4 Manufacturing
(a) INO-T shall ensure that all Supply Products provided to the Recipients by the INO-T Group shall meet the Specifications, the Standards and all Supply Product specifications set out in the Health Registrations and be manufactured in compliance with all Applicable Laws, including cGMPs.
(b) INO-T Shall ensure that the Bulk NO Gas supplied by it shall have a minimum remaining shelf-life of at least [**] months from the date of delivery.
10.5 Shipments
11. FINANCIAL TERMS
11.1 Supply of Supply Products by INO-T to the Recipients
(a) Bulk NO Gas: [**];
(b) INOvent: [**];
(c) INOvent Accessories: [**];
(d) INOcal Gas:
(i) for INOcal Gas purchased by INO-T pursuant to the Scott Medical Supply Agreement, [**] for that INOcal Gas pursuant to that agreement; or
(ii) for INOcal Gas purchased by the INO-T Group other than as described in Section 11.1(d)(i), [**] for that INOcal Gas pursuant to the relevant agreement; or
(iii) for INOcal Gas manufactured by INO-T, [**]; and
(e) INOmeters:
(i) for INOmeters purchased by INO-T pursuant to the Ventek Agreement, [**] for INOmeters pursuant to that agreement; or
(ii) for INOmeters purchased by the INO-T Group other than as described in Section 11.1(e)(i), [**] for those INOmeters pursuant to the relevant agreement; or
(iii) for INOmeters manufactured by INO-T, [**].
11.2 Fixed price invoicing
(a) No later than [**] of each calendar year the Parties shall agree on the:
(i) price for Bulk NO Gas, and any other Supply Product manufactured by INO-T, for the upcoming calendar year that will be invoiced by INO-T; and
(ii) amount by which the Recipients have overpaid or underpaid for those Supply Products supplied by INO-T during the previous calendar year (by comparing the invoiced price with the actual price calculated in accordance with Section 11.1), and payment shall be made by the relevant Party of such overpayment or underpayment within [**] days thereafter.
(b) INO-T shall:
(i) at AGA’s request, provide AGA with evidence reasonably sufficient to document any increase or decrease in Cost; and
(ii) promptly notify AGA, providing full particulars, if it becomes aware that the amount by which the Recipients will, or are likely to, overpay or underpay for Supply Products pursuant to Section 11.2(a) exceeds [**] dollars ($[**]) in any calendar year.
11.3 Payment period and disputed payments
(a) Without prejudice to AGA’s liability to pay any amounts pursuant to the Patent and Know-How License, the purchase price for the Products shall be paid in full by AGA (or the relevant Recipient) within [**] days of receipt of an undisputed invoice from INO-T.
(b) If AGA (or the relevant Recipient) receives an invoice from INO-T which it reasonably believes includes a sum which is not valid and properly due:
(i) AGA (or the relevant Recipient) shall notify INO-T in writing as soon as reasonably practicable;
(ii) promptly following receipt of AGA’s (or the relevant Recipient’s) notice under Section 11.3(b)(i), INO-T shall notify AGA (or the relevant Recipient) whether or not it believes that that invoiced sum is valid and properly due and:
(A) if it so believes, the matter shall be referred for resolution in accordance with Section 18.6; or
(B) if it does not so believe, INO-T shall revise and reissue that invoice accordingly;
(iii) AGA’s (or the relevant Recipient’s) failure to pay any amount in dispute shall not be deemed to be a breach of this Agreement;
(iv) AGA (or the relevant Recipient) shall pay the balance of the invoice which is not in dispute by the date specified in Section 11.3(a); and
(v) once any such dispute has been resolved, where either Party is required to make a balancing payment, it shall do so within [**] days.
11.4 United Stated Dollars
11.5 Return of Cylinders
12. OWNERSHIP OF HEALTH REGISTRATIONS, LINDE GROUP KNOW-HOW OR MANUFACTURING DATA
(a) Nothing in this Agreement or otherwise transfers any rights to the INO-T Group in any of the following to the extent that they are, as at the date of this Agreement, owned by the Linde Group (all of which are, and remain, proprietary to the Linde Group):
(i) Health Registrations in the Linde Territories;
(ii) marketing data relating to the Linde Territories; and
(iii) other related know-how or materials including pre-clinical, clinical, manufacturing, reporting and recall data relating to the Linde Territories,
(b) The Linde Group shall be entitled to apply for, hold and maintain Health Registrations (including in relation to the Products and Covox) in its own name in the Linde Territories.
13. PHARMACOVIGILENCE AND ASSISTANCE
13.1 Regulatory Assistance
(a) Each Party shall provide the other Party with access to all data (including source data and technical data) and materials that its Group possesses or has access to that may be required by that Party to maintain Health Registrations for the End Products, to prepare and update any submissions to Regulatory Authorities, or otherwise to comply with requirements from Regulatory Authorities and Applicable Laws, and shall make commercially reasonable efforts to ensure that all such data and documentation that may be requested by any Regulatory Authority are maintained in such a way that the other party can promptly respond to such requests in an appropriate manner.
(b) Each Party shall promptly forward to the other Party copies of any written communications received from Regulatory Authorities at any time regarding the Products, including the Health Registrations. If communications from Regulatory Authorities are not in writing, the substance of the oral communication shall be communicated. INO-T and AGA shall assist each other in such a way that each can report pharmacovigilance data to Regulatory Authorities based on the activities of both Parties.
(c) Without prejudice to Sections 15 and 16 and the other parts of this Section 13, promptly after having become so aware, each Party shall notify the other Party (including, if relevant, through the Joint Committee) of any event or fact that it believes is likely to have an adverse effect on any Health Registrations for the Products and/or Covox and the Parties shall cooperate to minimize any such adverse effect.
13.2 Clinical trials
(a) Except pursuant to Section 13.2(b), AGA shall not undertake or sponsor any Covox- or inhaled NO-related clinical trials without the written approval of INO-T.
(b) AGA shall be entitled to support Covox- or inhaled NO-related non-commercial clinical trials, including academic research and research performed by clinical physicians for their own purposes.
(c) AGA shall:
(i) promptly notify INO-T (through the Joint Committee) of any request made to AGA for AGA to support a non-commercial clinical trial of the type described in Section 13.2(b); and
(ii) to the extent that it is aware, keep INO-T informed (through the Joint Committee) of the progress of such clinical trials supported by AGA and consult with INO-T regarding recommendations for the manner in which those clinical trials ought to be conducted so as to minimize any risk to the Health Registrations for the Products and/or Covox.
13.3 Access to INO-T Database
(a) INO-T shall ensure that the Linde Group is able to access and use the INO-T Pharmacovigilance Database in the manner in which the Linde Group accesses and uses it as at the Effective Date, and enable the Linde Group to use it for all its drug products, including by ensuring that the:
(i) Linde Group shall at all times be able remotely to access all Linde Group data on the INO-T Pharmacovigilance Database;
(ii) INO-T Pharmacovigilance Database is maintained at least to the standards (including regarding availability, integrity, security, accessibility and functionality) to which it operates as at the Effective Date; and
(iii) INO-T Group and third parties are unable to access Linde Group data on the INO-T Pharmacovigilance Database, except on a need-to-know basis for the purpose of carrying out information technology-related tasks.
(b) AGA shall reimburse INO-T in respect of any reasonable costs incurred by INO-T Group exclusively in connection with the maintenance of the INO-T Pharmacovigilance Database for the Linde Group’s access to, and use of, it.
13.4 Back-up facilities
14. JOINT COMMITTEE
14.1 Constitution
(a) The Participants shall establish a joint committee (Joint Committee) which shall consist of an equal number of representatives of, on the one hand, AGA and, on the other hand, INO-T and Holdco (JC Members), initially designated at [**] JC Members appointed by each Party, provided that one JC Member appointed by INO-T shall be a representative of Holdco.
(b) Each JC Member shall be:
(i) a board member of, senior employee of, or senior consultant to, the Participant that he or she represents; and
(ii) responsible for function(s) relevant to this Agreement (including research, clinical development, regulatory, legal, manufacturing or commercialization).
(c) Each Party may replace their JC Members from time to time with persons of equivalent seniority on [**] days’ notice to the other Party.
(d) Each Party is entitled, on reasonable notice to the other Party and with that other Party’s approval, to invite to Joint Committee meetings employees or consultants other than its JC Members to address specific issues discussed at those meetings.
(e) The chairperson of the Joint Committee shall be the INO-T Chief Executive.
14.2 Functions
14.3 Meetings
(a) The Participants shall cause the Joint Committee to meet not less than [**] per Year (or less often if agreed by the Participants), and whenever requested by a Participant on reasonable prior notice, to discuss matters relevant to the functions referred to in Section 14.2.
(b) Meetings of the Joint Committee may be attended in person or by telephone or video conference. If in person, the location of the meeting shall alternate at a place decided by INO-T and AGA, sequentially.
(c) The chairperson of the Joint Committee shall, in consultation with the JC Members, be responsible for providing an agenda for each meeting at least [**] days in advance of that meeting.
(d) Responsibility for the preparation of minutes setting out discussions held at each Joint Committee meeting shall alternate between the Parties as directed by the chairperson, provided that such minutes shall not become official until agreed upon by the JC Members of the Participants. The minutes of Joint Committee meetings shall be reasonably detailed and distributed in draft to all JC Members for comment and review within [**] days after the relevant meeting. The JC Members shall have [**] days to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all JC Members within [**] days of the relevant meeting.
14.4 Decisions
15. PRODUCT RECALL
15.1 Mandatory Recall
(a) In the event of any mandatory recall of a Product in the Linde Territories, INO-T shall, if requested by AGA, assist AGA or the relevant member of the Linde Group, to identify the cause of the recall and take any measures required to avoid repetition of the cause of the recall. In the event that AGA can reasonably establish that the mandatory recall was caused, in whole or in part, by a breach by INO-T of this Agreement, INO-T shall indemnify AGA for the Loss incurred or suffered by the Linde Group in relation to the recall to the extent that it was caused by that breach by INO-T.
(b) AGA shall inform INO-T immediately of any mandatory recall of a Product in any of the Linde Territories.
(c) INO-T shall inform AGA immediately of any mandatory recall of a Product outside the Linde Territories.
15.2 Voluntary recall
(a) If a Party believes that a voluntary withdrawal or recall of a Product is necessary, both Parties shall promptly use their respective commercially reasonable efforts to agree whether it is necessary. If the Parties agree that it is necessary, in respect of the Linde Territories, AGA shall carry out that withdrawal or recall and, in respect of countries outside the Linde Territories and the Existing ROW Territories, INO-T shall carry out that withdrawal and recall. If the Parties cannot agree, in respect of a proposed voluntary withdrawal or recall:
(i) in the Linde Territories, AGA shall (if it believes that there is sufficient time) refer the matter to an independent third party qualified to assess the need for a recall and shall follow the recommendation of that third party. If AGA does not so believe, it may (in its absolute discretion) implement the voluntary withdrawal or recall provided that, in doing so, it shall take into account INO-T’s reasonable representations to AGA; and
(ii) outside the Linde Territories and the Existing ROW Territories, INO-T shall (if it believes that there is sufficient time) refer the matter to an independent third party qualified to assess the need for a recall and shall follow the recommendation of that third party. If INO-T does not so believe, it may (in its absolute discretion) implement the voluntary withdrawal or recall, provided that, in doing so, it shall take into account AGA’s reasonable representations to INO-T.
(b) Any and all costs related to the voluntary withdrawal or recall shall be paid by the Party which is responsible for that recall.
16. ADVERSE EVENT REPORTING
(a) The Parties shall, within [**] days of the Effective Date, mutually agree in writing to procedures that ensure that the INO-T Group and the Linde Group will be able to meet their obligations to report Adverse Events.
(b) AGA acknowledges that INO-T is obligated under Applicable Laws to report Adverse Events to certain Regulatory Authorities, and AGA agrees to comply with INO-T’s requirements so as to assure that INO-T is in compliance with such laws.
(c) INO-T acknowledges that the Linde Group is obligated under Applicable Laws to report Adverse Events to certain Regulatory Authorities, and INO-T agrees to comply with the Linde Group’s requirements so as to assure that the Linde Group is in compliance with such laws.
17. CONFIDENTIALITY AND ANNOUNCEMENTS
17.1 Confidentiality
(a) During the Term of this Agreement and for the longer of:
(i) [**] Years thereafter; and
(ii) for so long as any information in question shall have value as a trade secret,
(b) The term Confidential Information shall mean technical and business information, whether written, oral or in any other form, that one Participant shall provide to another Participant pursuant to this Agreement, with the exception only of the following:
(i) information which was known to or in the possession of the receiving Participant prior to the time of receipt from the disclosing Participant, except for information that was shared by a Party with a member of the Group of the other Party prior to the Effective Date where such information is of a type that a reasonable Person would deem to be confidential or proprietary, or the circumstances or nature of the information should reasonably put the other Party on notice that such information should be treated as confidential or proprietary, provided that nothing in this Agreement shall restrict or prevent the use by the Linde Group in relation to goods and services other than those concerning NO and carbon monoxide of information disclosed by INO-T to the Linde Group prior to the Effective Date and the Linde Group continues to handle such information in those circumstances with at least the same standard of care as it has applied to such information in those circumstances prior to the Effective Date;
(ii) information which as of the time of receipt is generally available to the public or subsequently becomes generally available to the public through no breach of this Agreement by the receiving Participant;
(iii) information which at any time is provided to the receiving Participant by a third party that was lawfully in possession of the same and had the lawful right to disclose the same;
(iv) information which at any time corresponds to information independently developed by the receiving Participant without the aid, use or application of any information which constitutes Confidential Information;
(v) information which is necessary or advisable to be disclosed by the receiving Participant to comply with Applicable Law, applicable rules or regulations of any securities exchange, or the request of any Governmental Entity, provided that the receiving Participant gives the disclosing Participant reasonable prior written notice to permit it to seek a protective order or other remedy to prevent or limit such disclosure, and thereafter discloses only the minimum information required to be disclosed in order to comply;
(vi) information which is necessary or advisable to be disclosed by the receiving Participant in connection with any suit, claim, investigation, arbitration, action or proceeding, provided that the receiving Participant gives the disclosing Participant reasonable prior written notice to permit it to seek a protective order or other remedy to prevent or limit such disclosure; and
(vii) information which is specifically permitted to be disclosed pursuant to the terms of this Agreement and/or any other Contract by and among the Parties and/or the Participants.
17.2 Announcements
18. TERMINATION
18.1 Termination by AGA
(a) AGA decides to discontinue commercial activities relating to all of the Products and Covox in the Linde Territories (which decision shall, for the avoidance of doubt, be in the sole discretion of AGA (including for commercial, scientific or medical reasons)), it shall notify INO-T in writing at least six (6) months prior to that discontinuance; and
(b) AGA notifies INO-T of its decision in accordance with Section 18.1(a), the six (6) months’ notice period specified in Section 18.1(a) expires, and AGA discontinues commercial activities relating to all of the Products and Covox in the Linde Territories, this Agreement shall terminate immediately.
18.2 Termination by INO-T
(a) In the event that, other than following one or more Persons acquiring, or deciding to acquire, directly or indirectly, all or substantially all of the assets of the INO-T Group relating to the Products and Covox:
(i) every member of the INO-T Group decides to discontinue commercial activities relating to all of the Products and Covox (which decision shall, for the avoidance of doubt, be in the sole discretion of the INO-T Group (including for commercial, scientific or medical reasons)), INO-T shall notify AGA in writing at least eighteen (18) months prior to that discontinuance; and
(ii) INO-T notifies AGA of the decision of the INO-T Group in accordance with Section 18.2(a)(i), the eighteen (18) months’ notice period specified in Section 18.2(a)(i) expires, and every member of the INO-T Group discontinues commercial activities relating to all of the Products and Covox, this Agreement shall terminate immediately. For the avoidance of doubt, this Agreement shall not terminate by reason of an acquisition as described in Section 23.4(b).
(b) INO-T may terminate this Agreement by giving AGA not less than six (6) months’ notice if AGA sells any Product or Covox:
(i) in an INO-T Territory; or
(ii) to a third party that AGA knows is intending to sell that Product or Covox in an INO-T Territory,
18.3 Material Breach
18.4 Return of Materials
18.5 Effect of Termination
(a) In the event that this Agreement is terminated other than pursuant to Section 18.1, or expires, INO-T shall use commercially reasonable efforts to assist:
(i) in AGA’s absolute discretion:
(A) the Recipients to find, and transition to, an alternative supplier of Bulk NO Gas in order that their requirements (including regarding quantity and delivery time) for Bulk NO Gas can be met; and/or
(B) if AGA so requests, the Linde Group to develop operational facilities for the manufacture of Bulk NO Gas, including by promptly providing, and causing the INO-T Group promptly to provide, to the Linde Group all relevant training, know-how, data, documentation, and other assistance in order that their requirements (including regarding quantity and delivery time) for Bulk NO Gas can be met; and/or
(ii) the Recipients to find, and transition to, an alternative supplier of any Supply Product (other than Bulk NO Gas) in order that their requirements (including regarding quantity and delivery time) for that Supply Product can be met.
(b) Expiration or termination of this Agreement shall not relieve the Participants of any liability or obligation accruing prior to such expiration or termination, and the provisions of Sections 1, 8.2, 17, 18.4, 18.5, 18.6, 19.1 and 23 shall survive the expiration or termination of this Agreement.
18.6 Dispute Resolution Procedure
(a) Any Dispute shall in the first instance be referred by notice in writing (the Referral Notice) by a Participant to the Representatives. The Participant delivering the Referral Notice (the Referring Party) shall identify in the Referral Notice:
(i) the matter(s) in dispute;
(ii) the relief and/or remedy sought; and
(iii) brief reasons for claiming the relief and/or remedy sought, including identification of the relevant provisions in this Agreement.
(b) The Representatives shall consider the Dispute and use the respective commercially reasonable efforts to try to reach agreement to resolve the Dispute. Any agreement of the Representatives to resolve the Dispute shall be final and binding on the Participants and shall be in writing.
(c) If the Representatives are unable to, or fail to, resolve the Dispute within [**] days of receiving the Referral Notice, then any Participant may within [**] days of the expiration of this time period refer the Dispute to the Joint Committee.
(d) If a Dispute is referred to the Joint Committee in accordance with Section 18.6(c), the Joint Committee shall consider the Dispute and use their respective commercially reasonable efforts to try to resolve the Dispute. Any unanimous agreement of the Joint Committee shall be final and binding on the Participants and shall be in writing.
(e) If the Joint Committee fails to resolve the Dispute within [**] days of receiving a copy of the Referral Notice, then any Participant may within [**] days of the expiration of this time period refer the Dispute to the Chief Executives.
(f) Any Dispute not finally resolved by the Chief Executives shall be finally settled by Arbitration as follows:
(i) In the event that any Dispute cannot be resolved pursuant to this Section 18.6, such Dispute shall be finally settled by binding arbitration (Arbitration) under the Rules of Arbitration (the Rules) of the International Chamber of Commerce (ICC) in force at the time of such Arbitration and the United States Federal Arbitration Act of 1925, as amended, by one or three arbitrators appointed in accordance with the Rules. The seat of the arbitration shall be New York, New York. The language of the arbitration shall be English.
(ii) In any Arbitration relating to any Dispute, the arbitrator or arbitrators shall be required to select one of the proposals submitted by or on behalf of AGA or INO-T and shall not be permitted to determine an alternative or compromise remedy.
(iii) The arbitral award shall be in writing, shall detail the disputed matters and reasons on which the arbitral award is based, and shall (except as provided in this Section 18.6 with respect to actions or applications for interim relief), be the sole and exclusive remedy among the Participants regarding any Dispute. The arbitral award shall be final and binding upon the Participants and shall not be subject to appeal of any court or other authority. Notwithstanding the foregoing, any party may file an application in the United States federal courts sitting in the Borough of Manhattan seeking pre-arbitral attachment, injunctive or other forms of interim relief to compel, aid or facilitate the arbitration or to maintain the status quo pending completion of the arbitration. Judgment upon the award or order may be entered in the Supreme Court of the State of New York sitting in the Borough of Manhattan, the United States District Court for the Southern District of New York or any other court of competent jurisdiction, and application may be made to any such court for enforcement thereof. Each Participant agrees not to oppose the registration or enforcement of any such judgment in any other jurisdiction and to consent to jurisdiction and venue in any applicable court for purposes of registration or enforcement of any such judgment. Each Participant accepts and submits to the jurisdiction of the seat of arbitration referenced above and to the New York State and United States federal courts sitting in the Borough of Manhattan (and to any court in which appeals from those courts may be heard) with regard to enforcement of the arbitral award or application for injunctive or other interim relief, as provided in this Section 18.6. Each Participant waives any defense or objection that it could have in relation to diplomatic immunity, lack of jurisdiction, improper venue, inconvenient forum or competence. Process in any such action or proceeding may be served on any Participant anywhere in the world. Each Participant irrevocably consents to the service of any and all process in any action or proceeding by the mailing or delivery of copies of such process to it at its address for notices specified in Section 23.6.
(iv) This Agreement and the rights and obligations of the Participants shall remain in full force and effect pending the award in any Arbitration proceeding hereunder.
19. INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE
19.1 Indemnification
(a) INO-T shall be liable for, and shall indemnify and hold harmless the Linde Group from all Losses suffered or incurred by the Linde Group to the extent arising out of, or relating to:
(i) any breach of the obligations of INO-T and/or Holdco under this Agreement; and/or
(ii) subject to Section 19.1(c), any claim, action or proceeding by a third party that is caused by the INO-T Group’s manufacture, handling, storage, promotion and/or delivery to Recipients of any of the Products, provided that each Party shall be solely liable for any claim, action or proceeding by a third party regarding the safety or efficacy of NO for therapeutic uses with respect to NO sold by a member of that Party’s Group in its respective Territory.
(b) AGA shall be liable for, and shall indemnify and hold harmless the INO-T Group from all Losses suffered or incurred by the INO-T Group to the extent arising out of, or relating to:
(i) any breach of the obligations of AGA under this Agreement; and/or
(ii) subject to Section 19.1(c), any claim, action or proceeding by a third party that is caused by the Linde Group’s manufacture, handling, storage, promotion, distribution and/or sale of any of the Products, provided that each Party shall be solely liable for any claim, action or proceeding by a third party regarding the safety or efficacy of NO for therapeutic uses with respect to NO sold by a member of that Party’s Group in its respective Territory.
(c) Subject to Section 19.1(d), INO-T shall not, pursuant to Section 19.1(a)(ii), and AGA shall not, pursuant to Section 19.1(b)(ii), have any liability or be required to indemnify the Group of the other Party to the extent that the Group of that other Party’s Losses, in aggregate, exceed five million euros (€5,000,000).
(d) The provisions of Section 19.1(c) shall not apply to any claim or cause of action arising from or relating to any fraud, intentional misrepresentation or willful covenant breach by the Party that is liable and/or obliged to indemnify and hold harmless the Group of the other Party in accordance with this Section 19.1.
19.2 Limitation of Liability
19.3 Insurance
(a) INO-T shall obtain and maintain, at its own expense, at all times during the Term and for six (6) Years following expiration or termination, Products/Completed Operations Insurance in an amount not less than two million dollars ($2,000,000) each occurrence and twenty million dollars ($20,000,000) annual aggregate for bodily injury and property damage combined single limit. Such insurance shall be from an insurer with a rating of “A” or higher by Moody’s Investors Services (or any successor rating agency) or Standard & Poors Corporation (or any successor rating agency)), naming AGA as an additional insured beneficiary thereof, and shall not be terminated, amended or modified without AGA’s prior written consent.
(b) In addition, INO-T shall obtain and maintain, at its own expense, all-risk property insurance covering the replacement cost value of the Supply Products while they are in its care, custody and control with a minimum limit of one million dollars ($1,000,000).
20. TAXES
(a) AGA shall, and shall cause the other members of the Linde Group to, be responsible for all sales, use, excise, goods, services, value added and like taxes relating to its and their import, distribution, handling and sale of the Products and New Indications in the Linde Territories.
(b) INO-T shall, and shall cause the other members of the INO-T Group to, be responsible for all sales, use, excise, goods, services, value added and like taxes relating to its and their sale to the Recipients of the Products and New Indications. INO-T shall, and shall cause the other members of the INO-T Group to, be responsible for all taxes of any kind relating to payments made by AGA, and the other members of the Linde Group, to INO-T under this Agreement and AGA, and the other members of the Linde Group, shall
have no obligation to gross-up any payment to INO-T for tax required to be withheld under Applicable Laws from any payment made to INO-T under this Agreement.
(c) The Parties agree to cooperate in order to minimize, in the manner permitted under applicable tax and customs Applicable Laws, the taxes (including value-added taxes) and duties associated with the importation and/or exportation and sale of the Products and New Indications, as the case may be.
21. WARRANTIES, REPRESENTATIONS AND COVENANTS
21.1 Capacity and Compliance
(a) Each Party represents and warrants to the other Party that:
(i) it is a corporation duly organized and validly existing under the laws of the jurisdiction of its incorporation;
(ii) it has full limited liability company or corporate (as the case may be) power and authority to enter into and perform under this Agreement;
(iii) all corporate actions necessary to authorize execution and delivery of this Agreement and to carry out its obligations hereunder have been duly taken; and
(iv) it has and shall maintain all licenses, permits, governmental approvals, Health Registrations and other authorizations necessary to perform its obligations hereunder.
(b) INO-T covenants and agrees that:
(i) the Products shall meet the Specifications and the Standards;
(ii) INO-T shall manufacture the Supply Products in conformity with the Specifications, and in a manner that fully complies with cGMP guidelines and practices.
(c) Each of INO-T and AGA covenants and agrees that it will market, sell and distribute the Supply Products and End Products, respectively, in compliance with Applicable Laws.
21.2 Changes in Manufacturing Process
(a) INO-T shall not change the manufacturing process, the Specifications, the raw materials or sources of third party products, used or the analytical testing method it applies in relation to the Supply Products in a way that has, or may have, an adverse effect on the Linde Group (Adverse Manufacturing Changes), unless, subject to Section 21.2(b), INO-T indemnifies AGA in respect of any Loss suffered by the Linde Group as a direct or indirect result of that Adverse Manufacturing Change. Any proposed Adverse Manufacturing Change shall be notified by INO-T to AGA before a final decision to change has been taken by INO-T.
(b) INO-T may make Adverse Manufacturing Changes required to comply with Applicable Laws or requirements of any Regulatory Authority without any obligation to indemnify AGA in respect of any Loss suffered by the Linde Group as a direct or indirect result of those Adverse Manufacturing Changes.
(c) INO-T shall provide AGA with a detailed written report of all changes to the manufacturing process, the Specifications, the raw materials and third party products, or the analytical method that:
(i) require approval from a Regulatory Authority before implementing them; and
(ii) do not require approval from a Regulatory Authority, unless agreed to by AGA in writing.
(d) If AGA is required by a Regulatory Authority to change the manufacturing process or the Specifications, INO-T shall accommodate the requested change unless doing so would adversely impact an INO-T Health Registration in the United States of America. AGA shall reimburse INO-T all costs incurred by INO-T in making the change, provided that, for the avoidance of doubt, if as a result of making such requested change INO-T is required to make more than one version of any Product, such reimbursement shall include reimbursement for all incremental costs associated with providing more than one version of such Product.
(e) If AGA requests a change in the manufacturing process or the Specifications in relation to the Products that is not a result of a requirement of a Regulatory Authority, INO-T shall use commercially reasonable efforts to accommodate the request. AGA shall reimburse INO-T all costs incurred by INO-T in making the change.
22. RIGHT OF FIRST OFFER TO PURCHASE LINDE’S EUROPEAN NO AND COVOX BUSINESSES
(a) If, at any time, AGA desires to sell to a third party that is not a member of the Linde Group:
(i) all or substantially all of its inhaled NO business (the NO Business);
(ii) all or substantially all of its Covox business (the Covox Business); or
(iii) both the NO Business and the Covox Business,
(b) Following the INO-T Election Date, AGA and INO-T shall endeavor to enter into a definitive purchase agreement in respect of the sale to INO-T of the Applicable Business, and the closing of the sale thereunder shall take place within the later of:
(i) [**] days after the execution of such definitive purchase agreement; and
(ii) the earlier of:
(A) [**] Business Days after receipt of all regulatory approvals without which the purchase may not be legally consummated; and
(B) [**] days from the date of the signing of the definitive purchase agreement (such [**] day, the Outside Closing Date).
(c) If, other than because AGA determines not to proceed with the sale of the Applicable Business, AGA and INO-T fail to enter into such a definitive purchase agreement within [**] days after the INO-T Election Date (the End Date), then the right to purchase the Applicable Business contemplated by this Section 22 shall be deemed to have been waived by INO-T and, for a period of [**] months from the End Date, AGA shall be free to enter into a definitive purchase agreement with any other Person, in a form no less favorable to AGA than the form last proposed by AGA to INO-T and rejected or (by expiration of such [**]-day period) deemed rejected by INO-T, and to consummate the purchase thereunder (it being agreed that any portion of the purchase price which is not in the form of cash or securities of a class which is publicly traded shall be valued by an independent valuation or appraisal firm selected by AGA, and any portion of
the purchase price which is in the form of securities of a class which is publicly traded shall be valued at the [**]). If such a definitive purchase agreement with any other Person is not entered into within such [**]-month period, any subsequent proposed sale of an Applicable Business shall again be subject to the right of first offer in favor of INO-T in this Section 22.
(d) If AGA and INO-T enter into the definitive purchase agreement contemplated by Section 22(b), but the closing thereunder does not occur:
(i) by the Outside Closing Date for reasons other than the breach of such definitive purchase agreement by AGA; or
(ii) because INO-T breaches its obligation to close or breaches any other provision of such definitive purchase agreement as a result of which AGA is permitted to terminate such definitive purchase agreement,
(e) If INO-T:
(i) fails to deliver an INO-T Election Notice within [**] days after the Notice Date; or
(ii) notifies AGA that it is declining to purchase the Applicable Business,
(f) The provisions of this Section 22 shall not apply to a transaction in which either:
(i) any other business of AGA or Linde AG or of members of either of their Groups are being sold and any Applicable Business is included, and such Applicable Business constitutes less than [**] percent ([**]%) of the aggregate total revenue of the businesses being sold; or
(ii) any Applicable Business is distributed in a spin-off, spin-out or other similar transaction in which the stockholders of Linde AG receive equity interests in such Applicable Business.
23. MISCELLANEOUS
23.1 INO Business Sale and Purchase Agreement
(a) The Parties acknowledge that it is their intention that, pursuant to Section 7.6(c) of the SPA, each of Linde Gas Inc., Holdco, Ikaria Acquisition Inc., and Ikaria shall, and Linde Gas Inc. (prior to the Effective Date) and Holdco and Ikaria Acquisition Inc. (following the Effective Date) shall cause INO-T to, use its respective reasonable best efforts (at its own expense) to obtain, and to cooperate in obtaining, all required or advisable consents, approvals, waivers, licenses, permits, authorizations, registrations, qualifications or other permission from, or action by, and giving all necessary notices to, INO Holdings LLC, Linde Gas LLC (formerly AGA Gas, Inc.) and Inoco, Inc. to transfer to INO-T the:
(i) accrued and future obligations of Linde Gas LLC (formerly AGA Gas, Inc.), AGA and any other members of the Linde Group pursuant to sections 2.3(b)(ii)-(iv) of Exhibit 2.3(b) of the INO Business Sale and Purchase Agreement (provided that any reference in those sections to a member
of the Linde Group shall be treated as a reference to the relevant member of the INO-T Group) to the extent that they relate to the business of INO-T outside the Linde Territories (the Assumed Obligations); and
(ii) accrued and future rights of Linde Gas LLC (formerly AGA Gas, Inc.), AGA and any other members of the Linde Group pursuant to the INO Business Sale and Purchase Agreement to the extent that they relate to the Assumed Obligations, which are the only existing or future rights that relate to the business of INO-T outside the Linde Territories (the Transferred Rights).
(b) In the event that the Parties are unable to transfer the Assumed Obligations and Transferred Rights in accordance with Section 23.1(a) and the SPA by the Effective Date, effective on and as of the Effective Date, as between the Parties:
(i) INO-T shall assume, satisfy and perform the Assumed Obligations for the benefit of AGA as if AGA were INO Holdings LLC; and
(ii) AGA shall, and shall cause the Linde Group to:
(A) comply with its obligations under sections 2.3(b)(ii)-(iv) of Exhibit 2.3(b) of the INO Business Sale and Purchase Agreement to the extent that they relate to the Assumed Obligations; and
(B) at INO-T’s request and expense, enforce the Transferred Rights on behalf of INO-T.
23.2 Independent Relationship
23.3 Amendments and Waivers
23.4 Assignment
(a) This Agreement and the rights and obligations hereunder shall not be assignable or transferable by any Participant without the prior written consent of the other Participants hereto except that a Participant may assign this Agreement and the rights and obligations hereunder, to an Affiliate or an acquirer of all or substantially all of the assets of such Participant. Any attempted assignment in violation of this Section 23.4(a) shall be null and void and of no effect.
(b) In the event that, directly or indirectly, one or more Persons acquire all or substantially all of the assets of the INO-T Group relating to the Products and Covox, INO-T shall, and Holdco shall cause INO-T to, assign this Agreement and the rights and obligations hereunder, to those Persons.
23.5 Third-Party Beneficiaries
23.6 Notices
(i) if to INO-T, to:
(ii) if to AGA to:
(iii) if to Holdco, to:
23.7 Counterpart Execution and Facsimile Delivery
23.8 Severability
23.9 Export Control
23.10 Force Majeure
23.11 Specific Performance
23.12 Governing Law
23.13 Waiver of Jury Trial
(a) certifies that no representative, agent or attorney of any other Participant has represented, expressly or otherwise, that such other Participant would not, in the event of litigation, seek to enforce the foregoing waiver; and
(b) acknowledges that it and the other Participants have been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section 23.13.
(a) Bulk NO Gas means cylinders of concentrated NO inhalation gas;
(b) INOcal Gas means cylinders of NO gas for use in calibration;
(c) INOmax means a finished drug product for inhalation which comprises NO diluted with nitrogen that is, at the date of this Agreement, distributed under the “INOmax” brand;
(d) INOmeter means a device that records the amount of time that a NO cylinder valve is in the open position;
(e) INOvent means an apparatus designed for administration of INOmax to patients; and
(f) INOvent Accessory means any accessory, service parts and/or repair parts for INOvent.
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