Document:

Exhibit 10.12

 

Execution Version

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

DRUG CLINICAL SUPPLY AGREEMENT

 

This Drug Clinical Supply Agreement (this “Agreement”) is entered into as of February 9, 2014 (the “Effective Date”) by and between by and between INO Therapeutics LLC, a Delaware limited liability company, with offices at Perryville III Corporate Park, 53 Frontage Road, Third Floor, Hampton, NJ 08827 d/b/a Ikaria (“Ikaria”), and Bellerophon Pulse Technologies LLC, a Delaware limited liability company, with offices at Perryville III Corporate Park, 53 Frontage Road, Third Floor, Hampton, NJ 08827 d/b/a Ikaria (“Pulse Technologies”).  Ikaria and Pulse Technologies may be individually referred to as a “Party” and together as the “Parties.”

 

WHEREAS, the Parties were formerly owned by a common parent company, Ikaria, Inc. (“Ikaria Parent Company”);

 

WHEREAS, Pulse Technologies has, as part of certain spin-out transactions (the “Spin-Out”), ceased to be a direct or indirect subsidiary of Ikaria Parent Company, and is now therefore not owned by, or affiliated with, either Ikaria Parent Company or Ikaria;

 

WHEREAS, Pulse Technologies is engaged in the business of developing, manufacturing, and commercializing products for (a) pulmonary hypertension secondary to chronic obstructive pulmonary disease (“COPD”), (b) primary or idiopathic pulmonary arterial hypertension (“PAH”), and pulmonary hypertension secondary to idiopathic pulmonary fibrosis (“IPF”; collectively, the “Pulse Technologies Clinical Programs”);

 

WHEREAS, prior to the Spin-Out, Ikaria manufactured nitric oxide for inhalation (the “NO”) and corresponding placebo (“Placebo”; collectively, “Product”) for use by Pulse Technologies as part of the Pulse Technologies Clinical Programs; and

 

WHEREAS, Pulse Technologies wishes Ikaria to continue on a short term basis to manufacture and supply, and Ikaria wishes to continue to manufacture and supply, the Product for Pulse Technologies, all subject to and in accordance with the terms and conditions of this Agreement.

 

NOW THEREFORE, in consideration of the foregoing premises, which are incorporated into and made a part of this Agreement, and of the mutual covenants which are recited herein, the Parties agree as follows:

 

1.                                      Definitions.

 

1.1                               “Affiliate” means, with respect to a Party, any Person directly or indirectly controlling, controlled by or under common control with, such Party.  For purposes of this definition only, “control” of a Person shall mean the ability, directly or indirectly, to direct the activities of the relevant Person, and with respect to corporate entities shall mean (a) ownership or direct control of fifty percent (50%) or more of the outstanding voting stock or other ownership interest of such Person, or (b) direct or indirect possession, of the power to elect or appoint fifty percent (50%) or more of the members of the governing body of such Person.  Notwithstanding the foregoing or any direct or indirect control relationship that exists between them, Ikaria and Pulse Technologies shall be deemed not to be Affiliates of one another.

 

1.2                               “Certificate of Analysis” means a document, signed by an authorized representative of Ikaria, describing (i) the Specifications for the applicable Product; (ii) the testing and methods applied to a batch or lot for such Product in order to verify compliance with the Specifications, and (iii) the results of such testing.

 

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1.3                               “cGMP” means the regulatory requirements for current good manufacturing practices promulgated by the FDA under the Food and Drug Act, including at 21 C.F.R. parts 210, 211 and 820. and under the Public Health Service Act, Biological Products, 21 C.F.R. parts 600 et seq., as the same may be amended from time to time.

 

1.4                               “COGS” means, as to Ikaria and its Affiliates, with respect to the Product, the aggregate of internal and external costs of Ikaria and its Affiliates to manufacture such Product, calculated as follows: (a) to the extent that Ikaria or its Affiliates performs all or any part of the manufacturing of such Product, the actual direct material costs and direct labor costs for, plus manufacturing overhead reasonably allocable to, such manufacturing of such Product (which may include the costs of audits, all directly incurred manufacturing variances, manufacturing administrative and facilities costs (including depreciation)), all calculated in accordance with GAAP; and (b) to the extent that manufacturing of such Product is performed by a Third Party, the costs paid to such Third Party for such activities  and the reasonably allocated direct labor costs incurred by Ikaria or any of its Affiliates in managing and overseeing the Third Party relationship, determined in accordance with GAAP.

 

1.5                               “Confidential Information” means information disclosed by a Party or its Affiliate (such Party referred to as the “Disclosing Party”) to the other Party or its Affiliate (such Party referred to as the “Receiving Party”), which information relates either directly or indirectly to the business of the Disclosing Party, including information and data regarding the manufacture or use, pre-clinical or clinical data regarding, the status of research or development of the Product.  Confidential Information of the Disclosing Party excludes any information that the Receiving Party can establish by written records: (a) was known by the Receiving Party prior to receipt from the Disclosing Party; (b) was disclosed to the Receiving Party by a Third Party having the right to do so; (c) was, or subsequently became, publicly known through no fault of the Receiving Party or its Affiliates; or (d) was concurrently or subsequently developed by personnel of the Receiving Party without having had access to the Disclosing Party’s Confidential Information.

 

1.6                               “COPD” shall have the meaning set forth in the recitals to this Agreement.

 

1.7                               “Effective Date” shall have meaning set forth in the preamble to this Agreement.

 

1.8                               “Facility” means Ikaria’s manufacturing facilities located in Port Allen, LA, or such other manufacturing site(s) specified by Ikaria from time to time.

 

1.9                               “FDA” means the United States Food and Drug Administration or any successor organization.

 

1.10                        “Federal Health Care Programs” shall have the meaning set forth in Section 7.3.

 

1.11                        “Forecast” shall have the meaning set forth in Section 2.4.

 

1.12                        “Ikaria Parent Company” shall have the meaning set forth in the recitals to this Agreement.

 

1.13                        “Intellectual Property” means, collectively, patents, trademarks, copyrights (including to any software, whether in object code or source code form), trade secrets, know-how, and any other intellectual or proprietary property or rights.

 

1.14                        “IPF” shall have the meaning set forth in the recitals to this Agreement.

 

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1.15                        “NO” shall have the meaning set forth in the recitals to this Agreement.

 

1.16                        “PAH” shall have the meaning set forth in the recitals to this Agreement.

 

1.17                        “Person” means any individual, governmental authority, partnership, corporation, limited liability company, unincorporated organization or association, any trust or any other business entity.

 

1.18                        “Placebo” shall have the meaning set forth in the recitals to this Agreement.

 

1.19                        “Product” shall have the meaning set forth in the recitals to this Agreement.

 

1.20                        “Product IP” shall have the meaning set forth in Section 2.9.

 

1.21                        “Pulse Technologies Clinical Programs” shall have the meaning set forth in the recitals to this Agreement.

 

1.22                        “Quality Agreement” has the meaning set forth in Section 4.1.

 

1.23                        “Regulatory Authority” means any competent governmental authority which regulates the manufacture, development or sale of the Product.

 

1.24                        “Specifications” means, with respect to the Product and Placebo, the specifications in effect for the Product immediately prior to the Spin-Out.

 

1.25                        “Term” has the meaning set forth in Section 10.1.

 

1.26                        “Third Party” means any Person who is not a Party or an Affiliate of a Party.

 

2.                                      Supply of Product.

 

2.1                               Obligations of Ikaria.  During the Term of this Agreement, Ikaria shall use commercially reasonable efforts to manufacture and supply Pulse Technologies’ requirements, and Pulse Technologies shall acquire from Ikaria its requirements, for the Product for the Pulse Technologies Clinical Programs in accordance with the terms of this Agreement and the Quality Agreement.  Pulse Technologies acknowledges and agrees that nothing in this Agreement shall require Ikaria to hire, obtain, or retain additional resources of any type (whether personnel, infrastructure, or otherwise), or to make capital expenditures of any kind, in order to manufacture and supply the Product, nor shall anything in this Agreement require Ikaria to prioritize manufacturing and supplying the Product to Pulse Technologies over performing similar services for its own benefit.

 

2.2                               Obligations of Pulse Technologies.  Pulse Technologies shall provide Ikaria with such information and cooperation as may be necessary for the manufacture and supply of the Product in accordance with this Agreement and the Quality Agreement.

 

2.3                               Commercial Supply.  If Pulse Technologies desires to obtain supply of any Product (or any variant thereof or any version with different specifications) for commercial use, then prior to negotiating the terms of an agreement for such agreement, Pulse Technologies shall promptly notify Ikaria thereof in writing.  Ikaria shall, within 60 days after receipt of such notice, indicate to Pulse Technologies in writing whether Ikaria or any of its Affiliates wishes to enter into such an agreement and, if Ikaria indicates that Ikaria or any of its Affiliates do wish to enter into such agreement, the Parties shall negotiate in good faith to enter into mutually agreeable terms pursuant to which Ikaria or any of its

 

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Affiliates would enter into agreement with Pulse Technologies.  In such negotiations, Ikaria may elect to supply [**]% of Pulse Technologies requirements for the Product(s) in question, or such lesser quantity as Ikaria may elect in its sole discretion.  If either (a) Ikaria indicates it does not wish to pursue such agreement, (b) Ikaria fails to indicate its interest within such 30 day period or (c) Ikaria indicates it wishes to enter into such agreement but the Parties fail to reach agreement on the terms of such agreement or to execute a definitive agreement prior to 90 days after the date of Ikaria’s indication of interest, then Pulse Technologies shall be free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such an agreement with a Third Party; provided that, in the event clause (c) of this sentence is applicable, if Pulse Technologies proposes to enter such agreement with a Third Party on terms that are materially less favorable to Pulse Technologies than the terms last offered in writing to Pulse Technologies by Ikaria, then (i) Pulse Technologies shall, prior to entering into such agreement with such Third Party, offer such terms to Ikaria, (ii) Ikaria shall have 15 days after the date of receipt of such offer from Pulse Technologies to notify Pulse Technologies in writing of its acceptance of such offer and (iii) (A) if Ikaria so accepts, the Parties shall promptly enter into a definitive agreement for the commercial supply of such Product(s) on such terms, or (B) if Ikaria does not accept, then Pulse Technologies shall be free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such commercial supply agreement with a Third Party; provided further that if Pulse Technologies does not enter into a definitive agreement for such commercial supply with a Third Party within 180 days after the expiration of Ikaria’s under this Section 2.3, Ikaria’s rights under this Section 2.3 shall be reinstated.

 

2.4                               Forecasts; Committed Quantities.

 

(a)                                 Commencing on the Effective Date and on the first business day of each calendar month thereafter, Pulse Technologies shall submit to Ikaria a written rolling forecast of the quantity of each Product which Pulse Technologies expects to order from Ikaria over the next 36 months (the “Forecast”).  The Forecast shall constitute a non-binding, good faith estimate provided by Pulse Technologies solely to assist Ikaria in production planning, and shall not represent a purchase commitment by Pulse Technologies or a supply commitment by Ikaria; provided, however, that the first six months of each such forecast shall constitute a binding purchase order hereunder for the specific Product for the quantities specified for that six-month period.

 

(b)                                 Each purchase of Product, and any acknowledgment thereof, shall be governed by the terms of this Agreement.  If a Party uses forms or documents to place or accept a purchase order that contain terms and conditions that are in addition to or contrary to those in this Agreement, the Parties agree and acknowledge that such forms or documents will be used for convenience only, and that no terms or conditions set forth therein, except with respect to quantity, shall be of any force or effect.

 

2.5                               Delivery.  Ikaria shall deliver the Product to a carrier selected by Pulse Technologies.  The Products shall be made available EXW the Facility (Incoterms 2010).  Title and risk of loss will pass to Pulse Technologies when the Products are made available to the carrier selected by Pulse Technologies.  Pulse Technologies is responsible for payment of all shipment costs, including any insurance necessary to guard against loss or damage during shipment.

 

2.6                               Certificates.  An appropriate Certificate of Analysis shall be provided with the shipment of each batch or lot of Product delivered to Pulse Technologies.

 

2.7                               Shipping Instructions.  Pulse Technologies will provide Ikaria with packaging and shipping instructions, including temperature requirements, temperature monitoring instructions and packaging specifications.  Notwithstanding any other provision of this Agreement, Ikaria will not be

 

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liable for any loss or damage caused by Ikaria’s compliance with Pulse Technologies’ packaging and shipping instructions or any loss or damage caused by Pulse Technologies’ carrier.

 

2.8                               Limited Use.  Pulse Technologies acknowledges and agrees that the Products may only be used in the Pulse Technologies Clinical Programs (and, if Ikaria has exercised its right under Section 2.3 to supply Products for commercial use, then also for that limited commercial use) and for no other uses or purposes.

 

2.9                               No Licenses.  Pulse Technologies acknowledges and agrees that nothing in this Agreement grants, or shall be deemed or interpreted to grant, to Pulse Technologies any right, title, or interest in or to any Intellectual Property reflected, contained, or incorporated in, or practice under, as part of or in the process of manufacturing and delivery of the Product (collectively, the “Product IP”).

 

2.10                        Changes.  Ikaria shall use commercial reasonable efforts to accommodate any reasonable changes to the Specifications for Product requested by Pulse Technologies, it being understood and agreed that Pulse Technologies shall bear any and all costs associated with such changes.

 

3.                                      Price and Payment

 

3.1                               Pricing.  Pricing for the Product and Placebo shall be COGS plus [**] percent.

 

3.2                               Payment.  Ikaria shall invoice Pulse Technologies at the time of shipment of Product in accordance with this Agreement.  Payment of an invoice is due the later of (a) thirty (30) days from the date of Pulse Technologies’ receipt of invoice; or (b) delivery of Product to the carrier in accordance with Section 2.5.

 

3.3                               Late Payments.  All amounts not paid when due shall bear interest from the due date at the rate of the lesser of (a) [**] percent ([**]%) per month or (b) the maximum amount permitted by applicable law.

 

4.                                      Quality.

 

4.1                               Quality Agreement.  The Parties shall use reasonable efforts to negotiate and conclude a quality agreement (“Quality Agreement”) within 60 days after the Effective Date.  The Quality Agreement shall detail the division of responsibilities between the Parties regarding quality and regulatory controls and reporting concerning the Product.  In the case of a conflict between the Quality Agreement and this Agreement, the terms of this Agreement shall control unless such term in the Quality Agreement expressly references such conflict and the Parties intend to have the Quality Agreement control such provision.

 

4.2                               Quality Assurance.  Ikaria shall perform quality testing using assays agreed to by the Parties in order to assure that Product complies with the Specification, and shall retain samples of Product as required by applicable law.  Ikaria shall maintain records, including batch or lot records, with respect to the quality testing.

 

5.                                      Non-Conforming Product.

 

(a)                                 Each batch or lot of Product delivered to Pulse Technologies hereunder shall be accompanied by a Certificate of Analysis.  Pulse Technologies shall have 30 days from the date of receipt of Product to inspect and reject acceptance by written notice to Ikaria; provided, however, that any such notice shall set forth Pulse Technologies’ reasons for rejection in reasonable detail and provided, further,

 

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that Pulse Technologies may reject Product only if: (i) Pulse Technologies claims a material breach of Ikaria’s representations and warranties in Section 7.2 of this Agreement with respect to such Product; or (ii) Ikaria has failed to deliver a Certificate of Analysis for such Product.  If Ikaria does not receive Pulse Technologies’ written notice of rejection within such 30 day period, Pulse Technologies shall be deemed to have accepted such Product.

 

(b)                                 If Pulse Technologies provides Ikaria with a timely notice of rejection as set forth in Section 5(a), Pulse Technologies shall return the rejected Product to Ikaria at Ikaria’s expense.  Ikaria shall have 30 days following receipt of the rejected Product in which to test such Product.  If Ikaria does not dispute a rejection, Ikaria shall rework or replace the rejected Product, at Ikaria’s expense and such rework or replacement shall constitute Pulse Technologies’ exclusive remedy and Ikaria’s sole liability with respect to such rejection.  If Ikaria disputes a rejection, Ikaria shall provide Pulse Technologies with written notice of such dispute within 30 days after receiving the returned Product, and the Parties shall use commercially reasonable efforts to resolve the dispute amicably and promptly.  If the Parties are unable to reach a resolution within 30 days after Pulse Technologies’ notice of rejection, the returned Product shall be submitted to an independent laboratory or consultant mutually acceptable to the Parties, whose decision as to the conformity of such Product with the applicable Specification shall be final and binding.  The Party against whom the dispute is decided shall pay any charges for such laboratory or consultant.  If the laboratory or consultant determines that the returned Product did not conform to the Specification, Ikaria shall rework or replace the rejected Product at no charge to Pulse Technologies, and such replacement shall constitute Pulse Technologies’ exclusive remedy and Ikaria’s sole liability with respect to such rejected Product.

 

6.                                      Audit Rights.  Pulse Technologies shall have the right to conduct reasonable audits and inspections of the Facility, Ikaria’s manufacturing operations, and Ikaria’s records relating to the manufacture of Product under this Agreement.  Ikaria shall reasonably cooperate with Pulse Technologies in conducting such audits and inspections.

 

7.                                      Warranties.

 

7.1                               General Warranties.  Each Party warrants to the other Party that (a) it has the right and authority to enter into this Agreement and to carry out its obligations hereunder; (b) it is validly existing in the jurisdiction in which it is incorporated and is authorized to do business under the laws of each jurisdiction in which it engages in business activities; and (c) it is not aware of any legal, contractual or other restriction, limitation or condition that might adversely affect its ability to perform its obligations hereunder.

 

7.2                               Warranties by Ikaria.  Ikaria warrants to Pulse Technologies that the Product delivered hereunder shall (a) conform in all material respects with its applicable Specifications and (b) be manufactured in compliance applicable law (including applicable cGMPs).  Pulse Technologies agrees that its exclusive remedies, and Ikaria’s sole liabilities, with respect to any breach of the warranty set forth in this Section 7.2 are set forth in Section 5(b) of this Agreement.

 

7.3                               Debarment.  Each party represents and warrants that, as of the Effective Date and throughout the Term, it (and each of its employees and agents) (a) is not currently excluded, debarred or otherwise ineligible to participate in the Federal health care programs as defined in 42 U.S.C. 1320a7b(f) (the “Federal Health Care Programs”); (b) has not been convicted of a criminal offense related to the provision of healthcare items or services but yet to be excluded, debarred or otherwise declared ineligible to participate in the Federal Health Care Programs; and (c) is not under investigation or otherwise aware of any circumstances which may result in it (or its agents, employees or any substitutes thereof performing any duties under this Agreement) being excluded from participation in the Federal Health

 

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Care Programs.

 

7.4                               DISCLAIMER.  EXCEPT AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY MAKES NOR RECEIVES ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, OR ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE PRACTICE, WITH REGARD TO THE PRODUCT OR OTHERWISE UNDER THIS AGREEMENT, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.

 

8.                                      Indemnity.  Pulse Technologies shall indemnify, defend and hold Ikaria, its Affiliates and their respective directors, officers, employees, agents, successors and assigns harmless from and against any damages, losses, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees), as and when incurred, resulting from any Third Party claims or suits arising out of the ownership, use, handling, development, distribution, marketing, or sale of any Product.

 

9.                                      Compliance.

 

9.1                               Compliance with Laws.  Each Party shall comply with all applicable laws and regulations governing the performance of such Party’s obligations under this Agreement.  Without limiting the foregoing, each Party shall comply with applicable US and other laws, rules and regulations that govern the import, export and re-export of the  Product, including the U.S. Export Administration Regulations, and will obtain any required export and import authorizations to perform its obligation hereunder.

 

9.2                               Regulatory Filings.  Pulse Technologies, at its expense, shall be solely responsible for the preparation, filing, and maintenance of all regulatory documents and all governmental permits, licenses and other approvals as may be necessary with respect to the formulation, marketing, distribution, sale, and use of the Product.

 

9.3                               Permits.  Ikaria at its expense shall be solely responsible for, and has the obligation to prepare, file, and maintain during the Term, all licenses, permits, and approvals as may be necessary with respect to the manufacture of Product at the Facility.

 

10.                               Term and Termination.

 

10.1                        Term.  Unless earlier terminated under Section 10.2, this Agreement shall commence as of the Effective Date, and unless earlier terminated pursuant to Section 10.2, shall expire on a Product by Product basis as follows (the “Term”):

 

(a)                                 With respect to Product for the Pulse Technologies Clinical Program for COPD, at the point in time that Pulse Technologies is no longer actively and continuously engaged that Pulse Technologies Clinical Program;

 

(b)                                 With respect to Product for the Pulse Technologies Clinical Program for PAH, at the point in time that Pulse Technologies is no longer actively and continuously engaged that Pulse Technologies Clinical Program; and

 

(c)                                  With respect to Product for the Pulse Technologies Clinical Program for IPF, at the point in time that Pulse Technologies is no longer actively and continuously engaged that Pulse Technologies Clinical Program.

 

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10.2                        Termination.  This Agreement may be terminated by either Party upon 60 days written notice of the other Party’s material breach of any provision of this Agreement; provided, however, that the breaching Party will have an opportunity to (a) cure the breach during the 60 day notice period, or (b) provide the non-breaching Party with a plan to remedy the breach within the 60 day notice period, and if so cured, no termination will be deemed to have occurred as long as the breaching Party diligently pursues the plan to remedy the breach and completes such plan in accordance with the time frame agreed to by the Parties (such time frame not to exceed an additional 60 days).  In addition, Ikaria may terminate this Agreement for any reason or no reason by giving 30 days’ notice to Pulse Technologies.

 

10.3                        Effect of Termination.  Termination or expiration of this Agreement shall not release either Party from any liability, right of action or other obligation which has arisen prior to such termination or expiration, including Ikaria’s obligation to deliver to Pulse Technologies such quantity of Product under any accepted purchase order to the effective date of termination or expiration, and Pulse Technologies’ obligation to pay Ikaria the amount set forth in such purchase order (except in the case of a material breach hereof by Pulse Technologies, in which case Ikaria may elect not to supply and manufactured but not yet delivered Product).  Notwithstanding any expiration or termination of this Agreement, the following provisions shall survive:  Sections 2.3, 2.8, 2.9, 5, 7.4, 8, 10.3, 11.1, 12 and 13.

 

11.                               Confidentiality.

 

11.1                        Non-Use and Non-Disclosure of Confidential Information.  Each Receiving Party agrees that all Confidential Information of the Disclosing Party (a) shall not be used by the Receiving Party except to perform its obligations or exercise its rights under this Agreement, (b) shall be maintained in confidence by the Receiving Party, and (c) except as permitted by Section 11.2, shall not be disclosed by the Receiving Party to any Person without the prior written consent of the Disclosing Party.

 

11.2                        Permitted Disclosures.

 

(a)                                 The Receiving Party may provide the Disclosing Party’s Confidential Information (i) to its Affiliates and to their employees, consultants, advisors, and contractors who have a need to know such Confidential Information for purposes of the Receiving Party exercising or granting licenses or sublicenses, (ii) in communications with existing or bona fide prospective acquirers, merger partners, lenders or investors, in each case of (i) and (ii), on a need to know basis and under appropriate confidentiality provisions substantially equivalent to those of this Agreement.

 

(b)                                 The Receiving Party may provide the Disclosing Party’s Confidential Information:

 

(i)                                     to the Receiving Party’s employees, consultants, advisors and contractors who have a need to know such Confidential Information and are bound by an obligation to maintain the confidentiality of the Disclosing Party’s Confidential Information;

 

(ii)                                  to patent offices or regulatory authorities in order to seek or obtain patent rights or approval to conduct clinical trials, or to gain regulatory approvals;

 

(iii)                               as reasonably required for development of the Product, in accordance with normal and customary commercial practice; or

 

(iv)                              if such disclosure is required by law (including by rules or regulations of any securities exchange) or to defend or prosecute litigation or arbitration; provided, that prior to such disclosure, to the extent permitted by law or such rules or regulations, the Receiving Party promptly

 

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notifies the Disclosing Party of such requirement and furnishes only that portion of the Disclosing Party’s Confidential Information that the Receiving Party is legally required to furnish.

 

12.                               Limitations of Liability.

 

12.1                        EXCEPT IN CONNECTION WITH PULSE TECHNOLOGIES’ INDEMNIFICATION OBLIGATIONS UNDER SECTION 8, IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES, BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS, LOST DATA, OR LOSS OF USE) ARISING OUT OF THIS AGREEMENT, REGARDLESS OF WHETHER SUCH DAMAGES ARE BASED ON TORT, WARRANTY, CONTRACT OR ANY OTHER LEGAL THEORY, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.  THIS EXCLUSION IS INDEPENDENT OF ANY OTHER REMEDY SET FORTH IN THIS AGREEMENT.

 

12.2                        TO THE FULLEST EXTENT PERMITTED BY LAW, IKARIA’S LIABILITY TO PULSE TECHNOLOGIES UNDER THIS AGREEMENT IS LIMITED TO THE AGGREGATE AMOUNTS PAID OR PAYABLE BY PULSE TECHNOLOGIES TO IKARIA IN RESPECT OF THE RELEVANT PURCHASE ORDER FROM WHICH THE CLAIM AROSE.

 

13.                               Miscellaneous.

 

13.1                        Notices.  All notices required or permitted to be given under this Agreement must be in writing and delivered to the other Party as set forth below.  Notices are validly given upon the earlier of confirmed receipt by the receiving Party or three business days after dispatch by a reputable courier or certified mail, return receipt requested.  Either Party may change its designated contact and address for purposes of notice by giving notice to the other Party in accordance with these provisions.

 

If to Ikaria:

 

INO Therapeutics LLC

Perryville III Corporate Park

53 Frontage Road, Third Floor

P. O. Box 9001

Hampton, NJ 08827

Attention:  General Counsel

 

If to Pulse Technologies:

 

Bellerophon Pulse Technologies LLC

Perryville III Corporate Park

53 Frontage Road, Third Floor

P. O. Box 9001

Hampton, NJ 08827

Attention:  General Counsel

 

13.2                        Escalated Dispute Resolution.  Prior to pursuing legal remedies hereunder, the Parties’ relationship managers agree to negotiate in good faith to resolve any disputes arising during performance of this Agreement.  If such negotiations and meetings do not resolve the dispute within 10 business days after notice of the dispute, then a senior executive from each Party will meet within 10 days or as agreed between them to attempt to resolve such dispute.  If the dispute is not resolved to the satisfaction of these

 

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executives within 10 days, then either Party may pursue all available legal remedies.  Notwithstanding the foregoing, either Party may seek injunctive relief with respect to any disputed matter without following the dispute resolution procedure set forth above.

 

13.3                        Force Majeure.  Neither Party will be liable for any failure or delay in performance of its obligations under this Agreement to the extent such failure or delay is caused by any event beyond such Party’s reasonable control, which may include fire, flood, explosion, unavailability of utilities or raw materials, labor difficulties, war, riot, act of God, export control regulation, or other laws or regulations, action or failure to act of any governmental authority, or any judgment, injunction or order of a court, administrative agency or regulatory authority having the effect of preventing or adversely affecting either Party’s performance under this Agreement.

 

13.4                        Independent Contractors.  The relationship of the Parties established under this Agreement is that of independent contractors and neither Party is a partner, employee, agent or joint venturer of or with the other.

 

13.5                        Assignment.   Except as otherwise provided in this Section 13.5, neither this Agreement nor any part hereof may be assigned or transferred by either Party, whether by operation of law or otherwise, without the other Party’s prior written consent.  Notwithstanding the foregoing, either Party may assign this Agreement, without the other Party’s prior consent, in the event of a sale or transfer of the business as to which this Agreement relates, whether such sale or transfer occurs by merger, reorganization, asset and/or stock purchase, or by any other means, provided that the assignee agrees in writing to assume all of the assignor’s obligations under this Agreement.  Any assignment or purported assignment in violation hereof shall be void.  This Agreement will be binding upon and inure to the benefit of the Parties and their permitted successors and assigns.

 

13.6                        Headings; Construction; Interpretation.  Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement.  The terms of this Agreement represent the results of negotiations between the Parties and their representatives, each of which has been represented by counsel of its own choosing, and neither of which has acted under duress or compulsion, whether legal, economic or otherwise.  Accordingly, the terms of this Agreement shall be interpreted and construed in accordance with their usual and customary meanings, and each of the Parties hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of law to the effect that ambiguous or conflicting terms or provisions contained in this Agreement shall be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement.  Any reference in this Agreement to an Article, Section, subsection, paragraph, clause or Exhibit shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause or Exhibit, of or to, as the case may be, this Agreement.  Except where the context otherwise requires, (a) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein); (b) any reference to any law refers to such law as from time to time enacted, repealed or amended; (c) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof; (d) the words “include,” “includes,” “including,” “exclude,” “excludes,” and “excluding,” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import; and (e) all references in this Agreement to “days” will, unless otherwise specified herein, mean calendar days.

 

13.7                        No Third Party Beneficiaries.  No provisions of this Agreement are intended to confer or give, or will be construed to confer or give, to any person or entity other than Ikaria and Pulse Technologies any rights, remedies or other benefits under or by reason of this Agreement.

 

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13.8        Severability.  If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid or unenforceable in any respect, such determination will not impair or affect the validity, legality or enforceability of the remaining provisions hereof, and each provision is hereby declared to be separate, severable and distinct.  To the extent that any such provision is found to be invalid, illegal or unenforceable, the Parties will negotiate in good faith to substitute for such provision, to the extent possible, a new provision that most nearly effects the Parties’ original intent in entering into this Agreement or to provide an equitable adjustment in the event no such provision can be added.  The other provisions of this Agreement will remain in full force and effect.

 

13.9        Entire Agreement.  This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior communications, representations or agreements, whether oral or written.  No modifications, amendments, or waiver of any term, condition or provision of this Agreement will be binding on either Party unless in writing and signed by an authorized representative of each Party.

 

13.10      Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey, USA, without giving effect to any conflict of law provisions.

 

13.11      Counterparts.  This Agreement may be executed in counterparts each of which, when executed and delivered, shall be original, but all such counterparts shall constitute one and the same document.  The Parties agree that signatures transmitted via portable document format (PDF) shall be deemed originals until originals replace such copies.

 

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IN WITNESS WHEREOF, each of the Parties has caused this Drug Clinical Supply Agreement to be executed on its behalf by a duly authorized officer on the date first set forth above.

 

	
INO THERAPEUTICS LLC d/b/a IKARIA
    	
 
    	
BELLEROPHON PULSE TECHNOLOGIES LLC
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Matthew M. Bennett
    	
 
    	
By: 
    	
/s/ Daniel Tassé
    
	
 
    	
 
    	
 
    
	
Name: Matthew M. Bennett
    	
 
    	
Name: Daniel Tassé
    
	
 
    	
 
    	
 
    
	
Title: Vice President & Secretary
    	
 
    	
Title: Chief Executive Officer
    
					

 

[Signature Page to Drug Clinical Supply Agreement]Exhibit 10.13

 

Execution Version

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

EMPLOYEE MATTERS AGREEMENT

 

by and between

 

IKARIA, INC.

 

and

 

BELLEROPHON THERAPEUTICS LLC

 

dated as of February 9, 2014

 

 

Employee Matters Agreement

 

This Employee Matters Agreement, dated as of February 9, 2014, is made and entered by and among Ikaria, Inc., a Delaware Corporation (“Ikaria”), and Bellerophon Therapeutics LLC, a Delaware limited liability company (“R&DCo”).  Ikaria and R&DCo are sometimes referred to herein individually as a “Party” and together as the “Parties.”  Capitalized terms used herein and not otherwise defined shall have the meanings assigned to them by the Separation and Distribution Agreement, dated as of the date hereof, between the Parties (the “Separation and Distribution Agreement”).

 

Recitals

 

WHEREAS, the Board of Directors of Ikaria has determined that it is appropriate, desirable and in the best interests of Ikaria and its stockholders to separate Ikaria into two independent companies, one for each of: (a) the Ikaria Business, which shall continue to be owned and conducted, directly or indirectly, in addition to any other line of business it may conduct, by Ikaria, and (b) the R&DCo Business, which shall be owned and conducted, directly or indirectly, by R&DCo (such separation, the “Separation”);

 

WHEREAS, pursuant to the terms of, and as described more fully in, the Separation and Distribution Agreement, the Parties will engage in a series of transactions culminating in the distribution to holders of shares of Ikaria Capital Stock, by means of one or more special dividends, of, in the aggregate, 100% of the R&DCo Voting Units (the “Distribution”); and

 

WHEREAS, in furtherance of the foregoing, the Parties have agreed to enter into this Agreement for purposes of (a) addressing the treatment of Employees who provide services to the R&DCo Business, the transfer of their employment to Bellerophon Services, Inc., a wholly owned subsidiary of R&DCo (“ServicesCo”), and their participation in employee benefit plans and programs following the Distribution; (b) addressing the effect of the Distribution on certain equity awards held by such Employees; and (c) allocating assets, liabilities, rights and responsibilities with respect to employee compensation and benefits and other employment matters as a result of the Separation.

 

NOW, THEREFORE, in consideration of the mutual promises contained herein and in the Separation and Distribution Agreement, the Parties agree as follows:

 

 

ARTICLE I.

 

DEFINITIONS

 

Section 1.1. Definitions

 

“Acquisition Agreement” means that certain Agreement and Plan of Merger, dated as of December 24, 2013, by and among Ikaria, Compound Holdings I, LLC, Compound Holdings II, Inc., Compound Merger Sub I, Inc. Compound Merger Sub II, Inc. and, solely in its capacity as Stockholder Representative, New Mountain Partners II, L.P.

 

“Agreement” means this Employee Matters Agreement, together with the exhibits, schedules, appendices, and annexes hereto.

 

“COBRA” has the meaning ascribed to it in Section 5.3.

 

“Code” means the United States Internal Revenue Code of 1986, as amended.

 

“Combined Group Employee” means any Employee, or following the Distribution, any Ikaria Employee or R&DCo Employee.

 

“CommercialCo FMV” means the fair market value of Ikaria as of immediately following the Distribution, which fair market value shall be determined by the Ikaria Board of Directors based on the aggregate fair market value of the merger consideration payable to the Ikaria securityholders (including but not limited to stockholders, option holders and restricted stock unit holders) pursuant to the Acquisition Agreement.

 

“Delayed Transfer Employee” has the meaning ascribed to it in Section 3.1(b).

 

“Distribution” has the meaning ascribed to it in the Recitals to this Agreement.

 

“Employee” means any individual who, prior to the Distribution, is or was employed by any member of the Ikaria Group, including any Transferred Employee and any Delayed Transfer Employee.

 

“Ikaria” has the meaning set forth in the preamble to this Agreement.

 

“Ikaria 401(k) Plan” means the Ikaria, Inc. 401(k) Plan as in effect or as it may be amended from time to time.

 

“Ikaria Acquisition” means the acquisition of Ikaria pursuant to the Acquisition Agreement.

 

“Ikaria Equity Award” means an equity award under an Ikaria Equity Plan after the adjustment provided in Section 7.1, including the Post-Distribution Ikaria Options and the Post-Distribution Ikaria RSUs.

 

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“Ikaria Equity Plans” mean the Ikaria Holding, Inc. 2007 Stock Option Plan and the Amended and Restated Ikaria Holdings, Inc. 2010 Long Term Incentive Plan.

 

“Ikaria Employee” means an individual who immediately following the Distribution remains employed by any member of the Ikaria Group. Such an individual shall remain an Ikaria Employee through his or her Transfer Date, if applicable, or other termination of employment with Ikaria.  “Ikaria Employee” shall also include, where applicable, the beneficiaries and dependents of an individual described in the first sentence of this definition.

 

“Ikaria Group” means Ikaria, Inc. and each of its subsidiaries (other than R&DCo or any R&DCo Group Member).

 

“Ikaria Plan” means any Plan maintained or sponsored by any member of the Ikaria Group.

 

“Ikaria Stock Option” means an option to acquire Ikaria non-voting common stock issued under an Ikaria Equity Plan.

 

“Ikaria RSU” mean a restricted stock unit representing the right to receive one share of Ikaria non-voting common stock issued under an Ikaria Equity Plan.

 

“Ikaria Welfare Plans” has the meaning ascribed to it in Section 5.1(a).

 

“Individual Agreement” means an individual employment contract or other similar agreement that specifically pertains to any Transferred Employee or Delayed Transfer Employee.

 

“Outstanding Equity Award” means an equity award under an Ikaria Equity Plan outstanding as of the day prior to the Distribution Date.

 

“Party” or “Parties” has the meaning ascribed to it in the preamble to this Agreement.

 

“Plan” means any plan, policy, program, payroll practice, on-going arrangement, contract, trust, insurance policy or other agreement or funding vehicle, whether written or unwritten, providing compensation or benefits to Employees, or former Employees of any member of the Ikaria Group or R&DCo, as the case may be, in respect to their services for the Ikaria Business or the R&DCo Business.

 

“Post-Distribution Ikaria Option” has the meaning ascribed to it in Section 7.1(a).

 

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“Post-Distribution Ikaria RSU” has the meaning ascribed to it in Section 7.1(b).

 

“Post-Distribution R&DCo Option” has the meaning ascribed to it in Section 7.1(a).

 

“Post-Distribution R&DCo RSU” has the meaning ascribed to it in Section 7.1(b).

 

“R&DCo” has the meaning ascribed to it in the preamble to this Agreement.

 

“R&DCo 401(k) Plan” has the meaning ascribed to it in Section 6.1.

 

“R&DCo Employee” means (a) each Transferred Employee and (b) effective upon the Transfer Date, each Delayed Transferred Employee. “R&DCo Employee” shall also include, where applicable, the beneficiaries and dependents of an individual described in the first sentence of this definition.  Following the Distribution, all R&DCo Employees shall initially be employees of ServicesCo.

 

“R&DCo Equity Award” means an equity award under the R&DCo Equity Plan issued in connection with the adjustment provided in Section 7.1, including the Post-Distribution R&DCo Options and the Post-Distribution R&DCo RSUs.

 

“R&DCo Equity Plan” means each Ikaria Equity Plan, to the extent assumed by R&DCo in connection with the Distribution and pursuant to this Agreement.

 

“R&DCo FMV” means the fair market value of R&DCo equity as of immediately following the Distribution to be determined based on an independent third party valuation.

 

“R&DCo Plan” means any Replacement Plan, each R&DCo Equity Plan and any other Plan established and adopted by R&DCo for the benefit of any R&DCo Employee.

 

“Replacement Plans” has the meaning ascribed to it in Section 4.1.

 

“Separation” has the meaning ascribed to it in the Recitals to this Agreement.

 

“ServicesCo” has the meaning ascribed to it in the Recitals to this Agreement.

 

“Transfer Date” has the meaning ascribed to it in Section 3.1(b).

 

“Transferred Employee” has the meaning ascribed to it in Section 3.1(a).

 

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ARTICLE II.

 

RELATIONSHIP AT AND FOLLOWING DISTRIBUTION

 

Section 2.1. Employees, Employee Liabilities Generally.

 

Except as provided in this Section 2.1, each of Ikaria and R&DCo shall be responsible for the Liabilities arising with respect to the employment by any member of the Ikaria Group or the R&DCo Group, as the case may be, of (a) each person in its employment immediately following the Distribution, and (b) each person whose last employment with any member of the Ikaria Group or the R&DCo Group was performing services for the Ikaria Business or the R&DCo Business, respectively. Notwithstanding the foregoing:

 

(i)                                     to the extent that compensation is payable to any Combined Group Employee in the form of or with respect to an Ikaria Equity Award, such compensation shall be payable by Ikaria and to the extent that compensation is payable to any Combined Group Employee in the form of or with respect to an R&DCo Equity Award, such compensation shall be payable by R&DCo; and

 

(ii)                                  to the extent that any benefit or compensation (including any benefit or compensation otherwise described in subclause (i)) is payable to, or any other Liability in respect of any such Combined Group Employee is expressly allocated to, Ikaria or R&DCo pursuant to the terms of this Agreement, such specific allocation shall control.

 

Section 2.2. Employees and Benefits Generally; Possibility of Transition Services.

 

As of the date hereof, all Employees actively engaged on a regular basis in the R&DCo Business are Employees of members of the Ikaria Group and such Employees participate in the Ikaria Plans.  Following the Distribution Date, pursuant to this Agreement, R&DCo will establish its own Plans and the participation of R&DCo Employees in the Ikaria Plans will cease as of the Distribution Date or as soon as practicable thereafter (or Transfer Date, as applicable).

 

ARTICLE III.

 

TRANSFERRED EMPLOYEES; ASSUMPTION OF LIABILITIES

 

Section 3.1. Transferred Employees.

 

(a)                                 General. The employment of, and all rights and obligations under any employment agreement with, any Employee identified on Schedule A hereto and any other Employee that the Parties agree to add to Schedule A after the date hereof (the

 

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“Transferred Employees”) will be transferred to ServicesCo immediately prior to the Distribution.

 

(b)                                 Delayed Transfer Employees. In the event that Ikaria and R&DCo agree to transfer the employment of any other Employee of any member of the Ikaria Group to ServicesCo in connection with the Distribution, but following the Distribution Date (each, a “Delayed Transfer Employee”), then effective as of the date the employment of such Delayed Transfer Employee is transferred or such other date as may otherwise be agreed in writing by the Parties (the “Transfer Date”), R&DCo shall assume all Liabilities of the type and nature that would have been assumed by R&DCo pursuant to Section 3.2 had such Delayed Transfer Employee been a Transferred Employee as of the Distribution Date, including all Liabilities arising during the period beginning on the Distribution Date and ending on the Transfer Date that arose in the ordinary course of business with respect to such Delayed Transfer Employee.

 

Section 3.2. Assumption of Liabilities. Except as otherwise expressly provided for in this Agreement, as of the Distribution Date (or, if later, the Transfer Date), R&DCo shall assume and agree to pay, perform, fulfill and discharge, in accordance with their respective terms, all Liabilities to or relating to Transferred Employees, Delayed Transfer Employees, and former Employees who primarily performed services for the R&DCo Business, to the extent relating to, arising out of, or resulting from employment with any member of the Ikaria Group on or prior to the Distribution Date (or, as applicable, the Transfer Date), including, without limitation, (i) Liabilities in respect of the reduction in force described on Exhibit E to the Acquisition Agreement and any other severance, bonus, benefits or other compensation obligations to or in respect of Transferred Employees, Delayed Transfer Employees, and former Employees who primarily performed services for the R&DCo Business (including the individuals listed in either schedule to that certain letter from Ikaria to Compound Holdings II, Inc. dated as of December 24, 2013), whether arising before or after the closing of the Ikaria Acquisition, (ii) the retention bonus pool to be distributed by Ikaria as described on Exhibit E to the Acquisition Agreement and (iii) all rights and obligations under an employment agreement with such Employees (and all such employment agreements will be assigned to ServicesCo).

 

Section 3.3. General Principles.

 

(a)                                 Non-Termination of Employment or Benefits. Except as otherwise expressly provided herein or as otherwise required by applicable law, no provision of this Agreement or the Separation and Distribution Agreement shall be construed to create any right, or accelerate any entitlement, to any compensation or benefit whatsoever on the part of any Employee. Without limiting the generality of the foregoing, except as may be explicitly provided in an Individual Agreement, neither the Distribution nor the transfer of employment shall cause any Employee to be deemed to have incurred a termination of

 

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employment or create any entitlement to any severance benefits or the commencement of any other benefits under any Ikaria Plan or any Individual Agreement.

 

(b)                                 No Right to Continued Employment. Nothing contained in this Agreement shall confer any right to continued employment on any Employee. Except as specifically provided otherwise herein, this Agreement shall not limit the ability of either Ikaria or R&DCo, as applicable, to change the position, compensation or benefits of any of its or its subsidiary’s Employees for a performance-related, business or any other reason or require any such entity to continue the employment of any such Employee for any particular period of time; provided that R&DCo shall bear all Liability associated with any such termination of employment or modification of terms and conditions of employment with respect to any R&DCo Employee and former Employees who primarily performed services for the R&DCo Business; and provided further that R&DCo covenants that its intent is to cause ServicesCo to continue to employ all of the R&DCo Employees pursuant to substantially similar terms and conditions as they are employed by Ikaria as of the date hereof and with such terms and conditions that are required under applicable law.

 

Section 3.4. Reimbursement.

 

(a)                                 By R&DCo. From time to time after the Distribution, R&DCo shall reimburse Ikaria promptly, and in no event more than fifteen business days after delivery by Ikaria of an invoice therefore containing reasonable substantiating documentation of such costs and expenses, for the cost of any obligations or Liabilities that Ikaria is required to pay or otherwise satisfy, that are, or that pursuant to this Agreement have become, the responsibility of R&DCo.

 

(b)                                 By Ikaria. From time to time after the Distribution, Ikaria shall reimburse R&DCo promptly, and in no event more than fifteen business days after delivery by R&DCo of an invoice therefore containing reasonable substantiating documentation of such costs and expenses, for the cost of any obligations or Liabilities that R&DCo is required to pay or otherwise satisfy, that are, or that pursuant to this Agreement have become, the responsibility of Ikaria.

 

ARTICLE IV.

 

R&DCO PLANS

 

Section 4.1. Establishment of R&DCo Plans. ServicesCo shall adopt, effective as of the Distribution Date or as soon as practicable thereafter, employee benefit plans that shall substantially replicate, to the extent commercially feasible, the following Ikaria Plans: a 401(k) plan, a medical and dental plan, Long-Term Disability, Short-Term Disability, Life and Accidental Death and Dismemberment, and Flexible Spending

 

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Accounts (the “Replacement Plans”).  ServicesCo shall become the plan sponsor of, and, from and after the date of adoption of each Plan, shall have sole responsibility for each Replacement Plan.

 

Section 4.2. Terms of Participation by R&DCo Employees.

 

(a)                                 Right and Entitlements. Except as otherwise agreed to by the Parties in accordance with Section 2.2 and the Transition Services Agreement, each R&DCo Employee shall terminate participation in the Ikaria Plans on the Distribution Date (or Transfer Date, as the case may be).  Subject to the express terms and conditions of this Agreement, each of the Replacement Plans shall be, with respect to R&DCo Employees who are participants in such Plans, the successors in interest to and shall recognize rights and entitlements under the corresponding Ikaria Plans in effect as of the Distribution Date in which such R&DCo Employees participated prior to the Distribution Date (or Transfer Date, as the case may be). The Parties agree that R&DCo Employees are not entitled to receive duplicative benefits for the same periods of service from the Ikaria Plans and the R&DCo Plans.

 

(b)                                 Service and Other Factors Determining Benefits. With respect to R&DCo  Employees, each R&DCo Plan shall provide that all service, all compensation, and all other factors affecting benefit determinations that, as of the Distribution Date or Transfer Date, were recognized under the corresponding Ikaria Plan (for periods immediately before the Distribution Date or Transfer Date, as applicable) shall receive full recognition, credit, and validity and be taken into account under such R&DCo Plan to the same extent that such service, compensation and other factors were taken into account under the corresponding Ikaria Plan, as though arising under such R&DCo Plan (or in the case of an R&DCo Plan that is not a Replacement Plan as if such individual had been employed by ServicesCo since his or her date of hire with any member of the Ikaria Group). Notwithstanding the immediately preceding sentence, in no event shall the crediting of service or any other action taken pursuant to the immediately preceding sentence result in the duplication of benefits for any Employee under any Ikaria Plan and any R&DCo Plan.

 

(c)                                  Power to Amend. Notwithstanding the foregoing provisions of this Section 4.2 and except as specifically set forth herein, nothing in this Agreement shall preclude R&DCo from amending, merging, modifying, terminating, eliminating, reducing, or otherwise altering in any respect any R&DCo Plan, any benefit under any Plan or any trust, insurance policy or funding vehicle related to any R&DCo Plan.

 

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ARTICLE V.

 

HEALTH AND WELFARE

 

Section 5.1. Assumption of Health and Welfare Plans.

 

(a)                                 Cessation of Coverage in Ikaria Plans. Ikaria maintains health and welfare plans for the benefit of eligible Employees (the “Ikaria Welfare Plans”). On the Distribution Date (or Transfer Date, as applicable) or such later date as may be agreed to by the Parties pursuant to Section 2.2  hereof or the Transition Services Agreement, each person who is an R&DCo Employee on such date shall cease to be covered under the Ikaria Welfare Plans. Notwithstanding the immediately preceding sentence, with respect to any R&DCo Employee who would not be eligible for coverage under any R&DCo Plan because such person is not actively at work on the Distribution Date (or Transfer Date) due to any medical, sickness, accident leave or any other approved leave of absence, Ikaria shall administer claims for such persons on behalf of R&DCo as though the relevant Ikaria Welfare Plan had continued to be applicable (at the cost and expense of R&DCo) until the earliest to occur of (i) the date such person first resumes active employment with ServicesCo; (ii) the date such person ceases to be an Employee of ServicesCo (including, without limitation, by reason of not returning to work at the expiration of any approved leave); (iii) the date on which such approved leave of absence expires without such person returning to active employment or terminating employment; and (iv) the date, if any, more than six months following the Distribution Date (or Transfer Date) that Ikaria shall choose, in its discretion, to cease to provide such continued coverage upon not less than 90 days advance written notice to R&DCo and the affected R&DCo Employees.

 

(b)                                 Claims Arising Prior to Distribution Date. On or after the Distribution Date, but subject to the obligations of R&DCo pursuant to Section 2.2, Ikaria and the Ikaria Welfare Plans shall remain responsible for all Liabilities in respect of or relating to R&DCo Employees relating to claims or expenses incurred on or prior to the Distribution Date (or Transfer Date, as applicable). For purposes of the foregoing sentence, to the extent that an eligible beneficiary under any such Ikaria Welfare Plan commences a hospital confinement on or prior to the Distribution Date (or Transfer Date) that continues after the Distribution Date (or Transfer Date), to the extent consistent with the applicable insurance policy under the Ikaria Welfare Plan, all expenses related to such hospitalization (including any related services that are incurred during the period of the same continuous hospital confinement) shall be considered part of the claim incurred on or prior to the Distribution Date (or Transfer Date). All other claims shall be deemed incurred on the date the actual expense is incurred.

 

(c)                                  No Transfer of Assets Pertaining to Welfare Plans. Nothing in this Agreement shall require Ikaria or any Ikaria Welfare Plan to transfer assets or reserves with respect to the Ikaria Welfare Plans to R&DCo.

 

Section 5.2. Terms of Participation in the R&DCo Welfare Plans. R&DCo shall cause the applicable R&DCo Plans to (a) waive all limitations as to preexisting

 

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conditions, exclusions, service conditions and waiting period limitations, and any evidence of insurability requirements applicable to any such R&DCo Employees other than such limitations, exclusions, and conditions that were in effect with respect to R&DCo Employees as of the Distribution Date (or Transfer Date), in each case under the corresponding Ikaria Welfare Plan and (b) honor any deductibles, out-of-pocket maximums and co-payments incurred by R&DCo Employees under the corresponding Ikaria Welfare Plan in satisfying the applicable deductibles, out-of-pocket expenses or co-payments under such Ikaria Welfare Plan for the calendar year in which the Distribution Date (or Transfer Date) occurs.

 

Section 5.3.                                 COBRA. R&DCo shall be responsible for liability associated with the continuation coverage requirements for “group health plans” under Title X of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), with respect to any R&DCo Employee and any of his or her dependents having rights derived from such R&DCo Employee with respect to qualified events incurred during any period commencing immediately following Distribution Date (or Transfer Date, as applicable).   Ikaria shall be responsible for liability associated with COBRA with respect to any Employee and any of his or her dependents having rights derived from such Employee where such individual has incurred an initial qualifying event prior to or through the Distribution Date (or Transfer Date), including any qualifying event incurred in connection with the transactions contemplated by this Agreement or the Separation and Distribution Agreement.

 

Section 5.4.                                 Workers’ Compensation Claims. Effective on the Distribution Date, R&DCo shall assume responsibility for all Liabilities for R&DCo Employees and any former Employees who primarily performed services for the R&DCo Business related to any and all workers’ compensation claims and coverage, whether arising under any law of any state, territory, or possession of the U.S. or the District of Columbia and whether arising before or after the Distribution Date.  For the avoidance of doubt, Ikaria shall be fully responsible for the administration of all such claims made prior to Distribution Date, but R&DCo shall reimburse and otherwise fully indemnify Ikaria for all Liabilities related to such claims in respect of such R&DCo Employees and any former Employees who primarily performed services for the R&DCo Business, including (a) the costs of administering the plans, programs or arrangements under which any such Liabilities have accrued or otherwise arisen, (b) paying benefits and settlements and (c) establishing reserves, in each case as determined by Ikaria or its designate.  With respect to any claim for worker’s compensation or similar benefits by an R&DCo Employee or any former Employees who primarily performed services for the R&DCo Business made after the Distribution Date, R&DCo shall be solely responsible for such claim and for complying with all applicable laws with respect thereto.

 

Section 5.5.                                 Flexible Spending Accounts.  As soon as reasonably practicable following the date that ServicesCo adopts a flexible spending account Replacement Plan,

 

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Ikaria will transfer the R&DCo Employees’ health-care and dependent-care spending account balances (determined as of such date (the “Flex Plan Transfer Date”)) under Ikaria’s flexible spending account plans to ServicesCo’s flexible spending account plan and the net aggregate flexible spending account balances for R&DCo Employees, positive or negative, will be offset from the next request for reimbursement by the Parties under this Agreement.  On and after the Flex Plan Transfer Date, ServicesCo’s flexible spending account plan shall be responsible for reimbursement of eligible health-care and dependent-care expenses incurred during the 2014 calendar year by R&DCo Employees and their respective eligible spouses and dependents (to the extent such expenses have no previously been reimbursed under Ikaria’s flexible spending account plan).

 

ARTICLE VI.

 

401(K) PLANS

 

Section 6.1.                                 Establishment of the R&DCo 401(k) Plan. R&DCo shall be responsible for taking or causing to be taken all necessary, reasonable, and appropriate action to establish, maintain, and administer a Replacement Plan intended to qualify under Section 401(a) of the Code having a cash or deferred feature qualified under Section 401(k) of the Code (the “R&DCo 401(k) Plan”) as soon as reasonably practicable following the Distribution Date.  For the avoidance of doubt, nothing in this Section 6.1 shall be construed to require R&DCo to maintain any particular investment option under such plan or to provide a company match, or a company match at the same level as in the Ikaria 401(k) Plan.

 

Section 6.2. Plan-to-Plan Transfer; Rollover. The Parties shall cooperate in effecting a plan-to-plan transfer of assets and liabilities from the Ikaria 401(k) Plan to the R&DCo 401(k) Plan.  In the event the Parties determine jointly that such a transfer is not practicable, the R&DCo 401(k) Plan shall accept direct rollovers of the R&DCo Employees’ balances in the Ikaria 401(k) Plan, including loan rollovers to the extent administratively feasible.

 

Section 6.3.  Employer Contributions.  To the extent that Ikaria contributes additional employer contributions following the Distribution Date (or Transfer Date, as applicable) to the Ikaria 401(k) Plan on behalf of R&DCo Employees or former Employees who primarily performed services for the R&DCo Business, R&DCo shall promptly reimburse Ikaria for the cost of such employer contributions that are allocated to such Employees’ accounts.

 

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ARTICLE VII.

 

EQUITY BASED AND OTHER LONG-TERM INCENTIVE AWARDS

 

Section 7.1. Assumption of Equity Incentive Plans; General Treatment of Outstanding Awards.

 

(a)                                 Treatment of Outstanding Ikaria Stock Options.   Prior to and in connection with the Distribution, each outstanding Ikaria Stock Option, whether vested or unvested, and each Ikaria Equity Plan itself, insofar as it relates to outstanding Ikaria Stock Options, shall be adjusted so that each Ikaria Stock Option shall become (i) an option to acquire, on the same terms and conditions as were applicable to such Ikaria Stock Option prior to the Distribution, an option to acquire the same number of shares of Ikaria non-voting common stock as were subject to the Ikaria Stock Option, at a price per share (rounded up to the nearest whole cent) equal to the product of (x) the quotient of (A) the CommercialCo FMV and (B) the sum of the (I) CommercialCo FMV and (II) the R&DCo FMV and (y) the exercise price per share of such Ikaria Stock Option (such options, the “Post-Distribution Ikaria Options”); and (ii) an option to acquire, on the same terms and conditions as were applicable to such Ikaria Stock Option prior to the Distribution, an option to acquire the same number of R&DCo non-voting common units as were subject to the Ikaria Stock Option, at a price per unit (rounded up to the nearest whole cent) equal to the product of (x) the quotient of (A) the R&DCo FMV and (B) the sum of (I) the CommercialCo FMV and (II) the R&DCo FMV and (y) the exercise price per share of such Ikaria Stock Option (such options the “Post-Distribution R&DCo Options”); provided, however, that Ikaria Stock Options held by holders who are not Accredited Investors or employees of Ikaria will also be adjusted pursuant to this Section 7.1(a), but the holders thereof will receive, in lieu of each such Post-Distribution R&DCo Option, an amount in cash equal to the product of (1) the difference between the fair market value of an R&DCo non-voting common unit (as determined by R&DCo) less the exercise price of the Post-Distribution R&DCo Option such holder would have been granted, multiplied by (2) the number of R&DCo non-voting common units that would have been subject to such R&DCo Option, less applicable withholding taxes, which cash amount R&DCo shall pay (or cause to be paid) to the holder promptly following completion of the Distribution.  Solely to the extent that Ikaria accelerates in full the vesting of the Post-Distribution Ikaria Options in connection with the Ikaria Acquisition, then R&DCo hereby undertakes to accelerate in full the vesting of the Post-Distribution R&DCo Options.

 

(b)                                 Treatment of Outstanding Ikaria RSUs.  Prior to and in connection with the Distribution, each outstanding Ikaria RSU, and each Ikaria Equity Plan itself, insofar as it relates to outstanding Ikaria RSUs, shall be adjusted so that each Ikaria RSU shall become (i) a restricted stock unit, on the same terms and conditions as were applicable to such Ikaria RSU prior to the Distribution, with respect to the same number of shares of Ikaria non-voting common stock as were subject to the Ikaria RSU (such restricted stock units, the “Post-Distribution Ikaria RSUs”); and (ii) a restricted unit, on the same terms and conditions as were applicable to such Ikaria RSU prior to the Distribution, with respect to the same number of R&DCo non-voting common units as were subject to the

 

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Ikaria RSU (such restricted units, the “Post-Distribution R&DCo RSUs”).  Solely to the extent that Ikaria accelerates in full the vesting of the Post-Distribution Ikaria RSUs in connection with the Ikaria Acquisition, then R&DCo hereby undertakes to accelerate in full the vesting of the Post-Distribution R&DCo RSUs and to settle such Post-Distribution R&DCo RSUs by the delivery of one R&DCo non-voting common unit with respect to each such Post-Distribution R&DCo RSU; provided, however, that a portion of the Post-Distribution R&DCo RSUs may be accelerated prior to the closing of the Ikaria Acquisition in the discretion of the Board of Directors of R&DCo.

 

(c)                                  Ikaria Equity Award Actions.  Ikaria shall continue the Ikaria Equity Plans to the extent necessary to govern the Ikaria Equity Awards following the adjustment contemplated by this Section and shall continue to take all corporate action necessary to reserve a sufficient number of shares of Ikaria non-voting common stock for delivery upon exercise of the Post-Distribution Ikaria Options issued pursuant to this Section and the settlement of the Post-Distribution Ikaria RSUs issued pursuant to this Section; provided, however, that (i) nothing herein shall limit Ikaria’s rights with respect to the disposition of an Ikaria Equity Award in accordance with the Ikaria Acquisition and (ii) the provisions of this Section 7.1(c) shall cease to apply following the closing of the Ikaria Acquisition.

 

(d)                                 R&DCo Equity Award Actions.  R&DCo shall assume each Ikaria Equity Plan solely to the extent necessary to govern the R&DCo Equity Awards and such plans shall be renamed as R&DCo Equity Plans.  R&DCo shall take all corporate action necessary to reserve for issuance a sufficient number of R&DCo non-voting common units for delivery upon exercise of the Post-Distribution R&DCo Options assumed in accordance with this Section and the settlement of the Post-Distribution R&DCo RSUs assumed in accordance with this Section.  For the avoidance of doubt and without limitation of Section 2.1(i), R&DCo shall be responsible for all Liabilities with respect to the R&DCo Equity Awards that remain outstanding following the Distribution, including (a) all income, payroll, or other tax reporting related to income of R&DCo Employees and Ikaria Employees from any R&DCo Equity Awards and (b) remitting the applicable tax withholdings for such income to each applicable taxing authority.  R&DCo shall provide written notice to Ikaria in the event that any Ikaria Employee exercises an R&DCo Equity Award, which notice shall be provided within thirty (30) days following R&DCo’s receipt of notice of such exercise.

 

ARTICLE VIII.

 

INCENTIVE PLANS

 

Section 8.1.                                 Incentive Plans. R&DCo shall be responsible for all Liabilities relating to R&DCo Employees in respect of any short term incentive plan related to their services for the R&DCo Business, including that, with respect to any Transferred

 

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Employee (or Delayed Transfer Employee or any former Employee who primarily performed services for the R&DCo Business), R&DCo shall be responsible for, or shall reimburse Ikaria for, the payment of any portion of any incentive payment payable to any Transferred Employee (or Delayed Transfer Employee or any former Employee who primarily performed services for the R&DCo Business) related to service performed in the applicable performance period through the Distribution Date (or, if applicable, the Transfer Date).

 

ARTICLE IX.

 

EXECUTIVE AGREEMENTS

 

[Reserved.]

 

ARTICLE X.

 

GENERAL AND ADMINISTRATIVE

 

Section 10.1.                          Sharing of Information. Subject to any consents required or any other restrictions imposed by law, each Party shall each provide to any other Party and its agents and vendors all information that such other Party may reasonably request to enable the requesting party to administer efficiently and accurately each of its Plans and to determine the scope of, and to fulfill, its obligations under this Agreement. Ikaria shall provide R&DCo or its designees, on a timely basis, such information including, without limitation, dates of termination, length of service and last known addresses, and other assistance as it or they shall reasonably request from time to time to administer its on-going obligations under this Agreement. Any information shared or exchanged pursuant to this Agreement shall be kept confidential by the Parties and used only for and to the extent necessary to establish, maintain and administer the plans, programs and agreements as contemplated by this Agreement.

 

Section 10.2. Cooperation.  Each of the Parties hereto will use its commercially reasonable efforts to promptly take, or cause to be taken, any and all actions and to do, or cause to be done, any and all things necessary, proper and advisable (including, without limitation, any actions required under applicable laws and regulations) to fulfill their respective duties and obligations contemplated by this Agreement. The actions described in the immediately preceding sentence shall include, without limitation, adopting plans or plan amendments and the payment of compensation due to any Employee, Ikaria Employee or R&DCo Employee. Each of the Parties hereto shall cooperate fully on any issue relating to the duties and obligations contemplated by this Agreement for which the

 

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other Party seeks a determination letter or any other filing, consent, or approval with respect to governmental authorities.

 

Section 10.3.                          Consent of Third Parties. If any provision of this Agreement is dependent on the consent of any third party (such as a vendor or insurer) and such consent is withheld, the Parties shall use their reasonable best efforts to implement the applicable provisions of this Agreement to the full extent practicable. If any provision of this Agreement cannot be implemented due to the failure of such third party to consent, the Parties shall negotiate in good faith to implement the provision in a mutually satisfactory manner.

 

Section 10.4. No Third Party Beneficiaries.

 

(a)                                 Except as provided in Section 10.4(d), nothing in this Agreement shall confer upon any person (or any beneficiary thereof) any rights under or with respect to any plan, program or arrangement described in or contemplated by this Agreement and each person (and any beneficiary thereof) shall be entitled to look only to the express terms of any such plan, program or arrangement for his or her rights thereunder.

 

(b)                                 Nothing in this Agreement shall create any right of any Person to object or to refuse to assent to R&DCo’s assumption of, succession to or creation of any Individual Agreement, or other agreement or plan, program or arrangement relating to employment, employment separation, severance or employee benefits, nor shall this Agreement be construed as recognizing that any such rights exist.

 

(c)                                  Nothing in this Agreement shall amend or shall be construed to amend any plan, program or arrangement described in or contemplated by this Agreement or to alter or limit R&DCo’s or any member of the Ikaria Group’s ability to amend, modify or terminate any particular benefit plan, program or agreement.

 

(d)                                 Except for Purchaser, which shall be a third party beneficiary of this Agreement, nothing in this Agreement is intended, or shall be deemed, to confer any rights or remedies upon any Person other than the Parties and their respective Group Members, successors and permitted assigns, to create any agreement of employment with any Person or to otherwise create any third-party beneficiary hereto or thereto.  This Agreement may only be amended with Purchaser’s consent (which shall not be unreasonably withheld).

 

Section 10.5. Notices. All notices and other communications under this Agreement shall be in writing and shall be deemed duly delivered (a) four Business Days after being sent by registered or certified mail, return receipt requested, postage prepaid, (b) one Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable nationwide overnight courier service, or (c) on the date of confirmation of

 

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receipt (or, the first Business Day following such receipt if the date of such receipt is not a Business Day) of transmission by facsimile, in each case to the intended recipient as set forth below.

 

If to Ikaria:

 

INO Therapeutics LLC

Perryville III Corporate Park

53 Frontage Road, Third Floor

P. O. Box 9001

Hampton, NJ 08827

Attention:  General Counsel

 

If to R&DCo:

 

Bellerophon Therapeutics LLC

Perryville III Corporate Park

53 Frontage Road, Third Floor

P. O. Box 9001

Hampton, NJ 08827

Attention:  General Counsel (or Chief Executive Officer if there is no General Counsel)

 

Either Party may give any notice or other communication hereunder using any other means (including personal delivery, messenger service, ordinary mail or electronic mail), but no such notice or other communication shall be deemed to have been duly given unless and until it actually is received by the Party for whom it is intended.  Either Party may change the address to which notices and other communications hereunder are to be delivered by giving the other Party notice in the manner herein set forth.

 

Section 10.6.                          Governing Law.  The internal Laws of the State of Delaware (without giving effect to any choice or conflict of law provision or rule, whether of the State of Delaware or any other jurisdiction, that would cause the application of Laws of any jurisdiction other than those of the State of Delaware) shall govern the construction, interpretation and other matters arising out of or in connection with this Agreement and each of the exhibits and schedules hereto and thereto (whether arising in contract, tort, equity or otherwise).

 

Section 10.7.                          Jurisdiction.  If any dispute, controversy or claim arises out of or in connection with this Agreement, the Parties irrevocably  (a) consent and submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware, New Castle County, or, if that court does not have jurisdiction, a federal court sitting in Wilmington,

 

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Delaware, (b) waive any objection to that choice of forum based on venue or to the effect that the forum is not convenient, and (c) WAIVE TO THE FULLEST EXTENT PERMITTED BY LAW ANY RIGHT TO TRIAL OR ADJUDICATION BY JURY.  Either Party may make service on the other Party by sending or delivering a copy of the process to the other Party at the address and in the manner provided for the giving of notices in Section 10.5.  Nothing in this Section 10.7, however, shall affect the right to serve legal process in any other manner permitted by Law.

 

Section 10.8                             Binding Effect and Assignment.  This Agreement binds and benefits the Parties and their respective permitted successors and assigns. Neither Party may assign any of its rights or delegate any of its obligations under this Agreement without the written consent of the other Party and any assignment or attempted assignment in violation of the foregoing shall be null and void.  Notwithstanding the preceding sentence, either Party may, upon written notice, assign this Agreement in connection with a merger transaction in which such Party is not the surviving entity or the sale of all or substantially all of its assets; provided that the surviving party or acquirer in such transaction agrees in writing to assume and be bound by all of such Party’s obligations hereunder.

 

Section 10.9                             Severability.  Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or thereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction.  If the final judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the Parties agree that the court making such determination shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified.  In the event such court does not exercise the power granted to it in the prior sentence, the Parties agree to replace such invalid or unenforceable term or provision with a valid and enforceable term or provision that shall achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable term.

 

10.10                 Specific Performance.  The Parties agree that irreparable damage would occur in the event that any provision of this Agreement were not performed in accordance with its specific terms or were otherwise breached.  It is accordingly agreed that either Party shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in each case without posting a bond or undertaking, this being in addition to any other remedy to which they are entitled at law or in equity.  Each of the Parties agrees that it shall not oppose the granting of an injunction, specific performance and other equitable relief on

 

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the basis that (a) the Party seeking such remedy has an adequate remedy at law or (b) an award of specific performance is not an appropriate remedy for any reason at law or equity.

 

Section 10.11                      Entire Agreement.  This Agreement, together with the Separation and Distribution Agreement and the other Ancillary Documents and each of the exhibits and schedules appended hereto and thereto, constitutes the final agreement between the Parties, and is the complete and exclusive statement of the Parties’ agreement on the matters contained herein and therein. All prior and contemporaneous negotiations and agreements between the Parties with respect to the matters contained herein and therein are superseded by this Agreement, the Separation and Distribution Agreement and the other Ancillary Documents, as applicable.  In the event of any conflict between (a) any provision in this Agreement, on the one hand, and (b) any specific provision in the Separation and Distribution Agreement, on the other hand, pertaining to the subject matter of this Agreement, the specific provisions in this Agreement shall control over the provisions in the Separation and Distribution Agreement, as applicable.

 

Section 10.12                      Amendment.  The Parties may amend this Agreement only by a written agreement signed by both Parties and that identifies itself as an amendment to this Agreement.

 

Section 10.13                      Termination.  This Agreement may be terminated (a) at any time after the Distribution, by the mutual written consent of Ikaria and R&DCo; or (b) at any time prior to the Distribution by (and in the sole discretion of) Ikaria without the approval of R&DCo.  In the event of a termination of this Agreement pursuant to the foregoing sentence, neither Party shall have any liability of any kind to the other Party under this Agreement, except for any breach of this Agreement that occurs prior to such termination.

 

[Signature Pages Follow]

 

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IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed on its behalf by a duly authorized officer on the date first set forth above.

 

	
IKARIA, INC.   
   a Delaware corporation
    	
BELLEROPHON   THERAPEUTICS LLC 
   a Delaware limited liability company
    
	
 
    	
 
    
	
By:
    	
/s/ James Briggs
    	
 
    	
By:
    	
/s/ Daniel Tassé
    
	
Name: James   Briggs
    	
Name: Daniel   Tassé
    
	
Title: Senior   Vice President,
    	
Title: Chief   Executive Officer
    
	
Human Resources
    	
 
    
					

 

[Signature Page to Employee Matters Agreement]

 

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SCHEDULE A TO EMPLOYEE MATTERS AGREEMENT

TRANSFERRED EMPLOYEES

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. [**]

 

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