Common use of Manufacturing Clause in Contracts

Manufacturing. (a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [***]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8.

Manufacturing. (a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [**] percent ([**]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8.

Manufacturing. (a) Ikaria Except as otherwise provided in this ------------- -------------- Agreement, the Research Plan or as LILLY and MEGABIOS may agree in writing, MEGABIOS shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territorydevelopment, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [***]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product material for Development preclinical testing and Commercialization purposes. If toxicology studies and material suitable for use in Phase I Clinical Trials as contemplated under this Agreement; [ * ] LILLY shall review, prior to Committee approval, all protocols for toxicology studies conducted under the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings terms of the JMCResearch Plan. If a representative of a Party is unable to attend a meetingAll applicable manufacturing and toxicology facilities (and materials made under this Agreement) shall comply with and be operated in accordance with all applicable GMP, such Party may designate an alternate to attend such meeting GLP, requirements specified in place of the absent representativeIND, and [ * ] Certain information on this page has been omitted and filed separately with the Commission. Each Party would bear its own costs Confidential Treatment has been requested with respect to its participation on the JMC. (e) The JMC would only act unanimouslyomitted portions. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolutionother regulatory requirements. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer LILLY shall have the right to decide audit all manufacturing and toxicology facilities described herein, including procedures and practices, to verify their conformance with applicable GMP, GLP and other regulatory requirements. MEGABIOS shall comply with all applicable governmental requirements, and shall provide LILLY with all information pertinent to regulatory approvals for manufacturing facilities. Additionally, a Manufacturing Requirements Document will be developed and agreed to prior to the matter taking into account Ikaria’s obligation manufacture and supply of the first Phase I Clinical Trial Product material. An outline of the initial content for the Manufacturing Requirements Document is included in Appendix II. MEGABIOS shall provide to LILLY, in the format reasonably specified by LILLY, all information related to the chemistry manufacture and control of the Product required for regulatory submissions. Notwithstanding the foregoing, such manufacture and supply by MEGABIOS, together with other activities under the Project, shall not require expenditure by MEGABIOS beyond the funding provided in Section 3.1 below. MEGABIOS will operate under cGMP control which is appropriate to its Phase I clinical trial manufacturing activity, as described in the FDA Guideline on the Preparation of Investigational New Drug Products (Human and Animal), March 1991, or any applicable successor thereto. MEGABIOS will supply product manufactured in accordance with current GMP's and in compliance with the requirements and specifications in LILLY's IND. LILLY, at its discretion, shall have the sole right (and responsibility related thereto) for the manufacture of all material, if any, related to the Product(s) beyond Phase I Clinical Trials. LILLY may appoint any Affiliate or third party to perform all or a portion of such manufacturing activities. Each appointee shall be required to undertake in writing for the benefit of MEGABIOS not to disclose any Manufacturing Information (as defined in Section 4.3) to any third party or to use Commercially Reasonable Efforts under such Manufacturing Information outside the scope of the license set forth in Section 3.85.1.

Manufacturing. (a) Ikaria The Advisory Committee shall be solely responsible advise the parties as to the recommended manufacturer of Compound and Licensed Product for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [***]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer XXXXX shall have the right to decide choose to manufacture the matter taking into account Ikaria’s obligation Compound and the Licensed Product for sale in the Territory, or to use Commercially Reasonable Efforts under choose a third party outside manufacturer as long as the price, capability and other terms are competitive with other third party manufacturers. Additionally, the COMPANY and its U.S. partner intend to out-source manufacturing and would consider XXXXX as a possible additional manufacturer for the U.S. market. If XXXXX elects to manufacture the Compound or the Licensed Product for either the Territory or for the U.S. market, XXXXX shall be responsible and pay for 100% of all costs incurred which are directly or indirectly related to the manufacture of the Compound or Licensed Product by XXXXX ("XXXXX Manufacturing Costs") and XXXXX shall reimburse the COMPANY for 100% of costs and time incurred by the COMPANY in conjunction with XXXXX Manufacturing Costs. XXXXX Manufacturing Costs shall include, but not be limited to, the galenical development of the tablet or capsule; the development and testing of manufacturing methods and processes; stability studies; scale-up of manufacturing; capital equipment and facilities used for manufacturing; administrative or overhead costs; materials, supplies and labor used in manufacturing; and regulatory costs or requirements associated with manufacturing. Bioavailability and bioequivalence studies undertaken by the COMPANY or XXXXX in connection with the tablet/capsule development activities are to be accounted for as development costs and are not to be considered as part of XXXXX Manufacturing Costs, and therefore, in accordance with Section 3.83.2, XXXXX shall reimburse the COMPANY for 60% of the cost incurred by the COMPANY for these studies and the COMPANY shall reimburse XXXXX for 40% of the cost incurred by XXXXX for these studies. In accordance with Section 6.1 and Schedule 6.1, XXXXX shall include in the quarterly royalty calculation a charge for bucindolol manufacturing costs which shall be based on mutually agreed market prices for the Compound or Licensed Products. The market price must be competitive with other third party FDA approved manufacturers, or other manufacturers with approvals by appropriate European regulatory agencies, of similar products. No other XXXXX Manufacturing Costs shall be charged to or paid by the COMPANY.

Manufacturing. (a) Ikaria TRADE XXXX LICENSE ---------------------------------- Clinical Materials ------------------ 6.1 Prior to the time that Glycyx has received adequate supply of Products, Biorex shall be solely responsible use its commercially reasonable efforts to supply, or to arrange for the Manufacture others to supply, Glycyx's requirements of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date preclinical tests and human clinical trails on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the reasonable terms and conditions thereof are acceptable conditions. In the event that Biorex arranges for Third Parties to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreementdevelop formulations of, (x) Ikaria shall be required or supply, Products to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRxBiorex under this Section 6.1, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [***]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party Biorex shall use commercially reasonable efforts to cause acquire the right to include the manufacturing processes and technology used by such Third Party for such Product in the Technical Information, Manufacturing Technology or the Patent Rights, so that Glycyx may use such process to manufacture such Product. Manufacturing Technology ------------------------ 6.2 As soon as practicable following a request by Glycyx, Biorex shall disclose to Glycyx all Manufacturing Technology in existence at such time, and shall hereafter promptly (and in any event at least quarterly) provide Glycyx with updates or additions to such Manufacturing Technology that are subsequently developed or acquired by Biorex or its representatives Affiliates. In addition, Biorex shall use all reasonable efforts to attend so provide to Glycyx all similar items and information generated or developed by or for other licensees of Biorex and to permit Glycyx to use such items and information to the meetings same extent it may use Manufacturing Technology hereunder. 6.3.1 Subject to the provisions of this Agreement, Biorex hereby grants to Glycyx the exclusive right and license to use the Trade Xxxx in connection with the exploitation of the JMC. If a representative Products in the Territory throughout the term of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMCthis Agreement. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer 6.3.2 Glycyx shall have the right to decide grant Sublicensees the matter taking into account Ikaria’s obligation right to use Commercially Reasonable Efforts under Section 3.8the Trade Xxxx in connection with the exploitation of the Products in the Territory throughout the terms of this Agreement, subject to the provisions of this Agreement. 6.3.3 Subject to the laws of the country concerned, Glycyx shall have an exclusive right to institute and pursue actions to prevent misuse of the Trade Xxxx throughout the Territory.

Manufacturing. (a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty [**] percent (20[**]%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [**] percent ([**]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8.

Manufacturing. Virgin shall cause the manufacturing of all ------------- Products hereunder in accordance with the following: (aA) Ikaria shall be solely responsible for With respect to personal computer Products, Interplay will timely provide golden or glass masters, films, and other usual materials to allow Virgin to carry out manufacturing of the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licenseeshereunder. (bB) BioLineRx Ltd. shall have the option (either directly or through an Affiliate)With respect to personal computer Products, exercisable in its sole discretion no later than [***] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to except as may be negotiated in good faith directed by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [***]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs Interplay with respect to a particular Product or order, Virgin will be fully responsible for all phases of manufacturing hereunder and in all such cases Virgin will obtain the same or better pricing than Virgin receives for manufacturing of comparable quantities of its participation own products on the JMC. (e) The JMC would only act unanimouslycomparable build schedules. IfAs a matter of clarity, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer Interplay shall have the right to decide provide finished goods to Virgin and to manage the matter taking into account Ikaria’s obligation manufacturing function in its discretion by providing notice to Virgin. (C) With respect to Products on video game console systems (e.g., PlayStation, N64, Dreamcast), Interplay shall be responsible for ordering the Products from the system licensor and the payment of the cost of goods and royalties to such system licensors. Virgin agrees that Interplay may, subject to Virgin's approval (which shall not be unreasonably withheld), utilize Virgin's line of credit with any of the system licensors to facilitate ordering Products for distribution hereunder, to the extent there is availability under such line of credit(s) at the time Interplay is seeking to place such orders and such credit availability is not reasonably anticipated to be required by Virgin during the succeeding [*] period. In the event that Interplay utilizes such credit availability, such amounts, together with any interest or other costs payable to the system licensor, shall be paid by Interplay on or before the earlier to occur of (i) such date as Virgin has to pay down such line of credit for the particular order or requires access to the portion of the facility used by Interplay for Virgin's own orders, provided that Interplay is given at least [*] prior written notice of such date, and (ii) [*] following such utilization by Interplay. (D) The parties will consult with and agree in advance in writing on a manufacturing and inventory schedule for each Product to be included hereunder. Such schedule will specify, among other things: (i) the number of units of each Product to be manufactured for the initial launch of such Product, (ii) the appropriate level of inventory to be maintained for such Product thereafter, and (iii) the appropriate timing and size of reorders of such Product. (E) Virgin will designate one of its employees to act as the primary liaison between Virgin and Interplay with respect to all sales, marketing, financial, logistical and other matters relating to this Agreement and the activities contemplated hereunder. (F) Virgin will use Commercially Reasonable Efforts under Section 3.8its commercially reasonable efforts to advise Interplay as soon as Virgin becomes aware of any potential conflict between the planned release of one of the Products and the release of any other products distributed by Virgin. (G) In the event of an overage, duplicate or unauthorized production of units of a Product, the cost of which is to be charged to Interplay hereunder, Virgin must give Interplay notice within ten (10) business days of the receipt of such shipment. Virgin shall use its diligent efforts to cause the manufacturer of such units of the Product to issue a credit for the incorrect portion of the order, such credit being for the benefit of Interplay. In the event Virgin is unable to obtain such credit for the benefit of Interplay, Virgin shall not pay the manufacturer for the incorrect portion of the order without the prior written consent of Interplay, which consent shall not be unreasonably withheld, and shall be deemed given unless Interplay provides written notice that such consent will be withheld within ten (10) business days following receipt by Interplay of a request for such consent.

Manufacturing. (a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees. (b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] six (6) months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [***], provided that the price shall not exceed [**] percent ([**]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives to the JMC at any time upon notice to the other Party. (d) The JMC would meet at least [***] or more or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8.

Manufacturing. (a) Ikaria During the term of this Agreement, Hydro Med will manufacture, package, produce and provide to Xxxxxxx, Xxxxxxx' total requirements of Product on an exclusive basis. Subject to the provisions of Section 2.2(e) hereof, Xxxxxxx shall not permit any party other than Hydro Med to manufacture and produce the Product. Such manufacturing shall be solely responsible for performed to the Manufacture best of Products for Development or for Commercialization Hydro Med's ability in accordance with the terms hereof and in accordance in all material respects with the terms and conditions described in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees.Technical Agreement attached hereto as Exhibit A. (b) BioLineRx Ltd. All Xxxxxxx Materials required in connection with the production and manufacture of the Product shall be supplied to Hydro Med by Xxxxxxx at Xxxxxxx' sole cost and expense and shall comply with the Specifications. Once the parties hereto have obtained all necessary approvals from the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [***] months prior FDA to market and sell the date on which Ikaria intends to file for Regulatory Approval Product in the U.S.United States, Xxxxxxx shall, during the term hereof, deliver to Manufacture Hydro Med, on a semi-annual basis, a sufficient volume of Xxxxxxx Materials to enable Hydro Med following each such delivery to produce the Product pursuant at the Plant in an amount necessary to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its satisfy Xxxxxxx' then current volume requirements for the Product from BioLineRx, for at least a six (6) month period in accordance with the most recent Purchase Order furnished by Xxxxxxx to Hydro Med pursuant to Section 2.2 (c) hereof . Title to all Xxxxxxx Materials furnished by Xxxxxxx to Hydro Med shall remain in Xxxxxxx and (y) the per unit price for the Product materials shall be segregated in Hydro Med's Plant and clearly and conspicuously labeled as Xxxxxxx' property until such time as such Xxxxxxx Materials are used in the [***], provided that the price shall not exceed [***]%) production of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost. (c) The Parties will discuss Product produced hereunder shall be manufactured by Hydro Med in accordance with Applicable Laws (including current Good Manufacturing Practices (cGMP)) and Hydro Med's current production standards and practices at the most efficient structure for Plant. Either party hereto may, from time to time, during the Manufacture and supply term of Product for Development and Commercialization purposes. If this Agreement, request the Parties determine approval of the other party to a change in such standards or practices, which approval shall not be unreasonably withheld; provided that coordination in Manufacturing if any such requested change is appropriatenot agreed to, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [***] representatives of Ikaria standards and [***] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its initial designation of its representatives not later than [***] days after the Parties agreed to establish the JMC. Each Party shall designate as its representatives individuals who have the requisite experience and knowledge to discuss the Manufacturing of Products. Each Party would be permitted to change any one or more of its representatives practices in effect immediately prior to the JMC at any time of such request shall remain valid and in effect. Any and all changes to such practices and standards shall be made only pursuant to the written agreement of the parties hereto, or, if required in order for Hydro Med to remain in compliance with Applicable Laws following the date hereof, upon written notice from Hydro Med to Xxxxxxx, such notice to specify in reasonable detail the other Partybasis for such changes; provided that Hydro Med shall be entitled to increase its standards costs of production to the extent of any increase in production costs resulting from any change in production standards or practices pursuant to this Section 2.1(c) from those in effect on the date hereof. In the event that the production standards or practices of Hydro Med are changed pursuant to the provisions of this Section 2.1(c), Hydro Med shall thereafter manufacture the Product hereunder in compliance with such changed production practices and standards. (d) The JMC would meet at least [***] Nothing contained herein shall limit, restrict or more prohibit Hydro Med during the term of this Agreement from soliciting for manufacture or less frequently as the JMC may agree. The location of such meetings shall be as mutually agreed by the Parties. The JMC may also meet by means of a telephone or video conference call. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JMC. If a representative of a Party is unable to attend a meetingmanufacturing other products, such Party may designate an alternate to attend such meeting goods and items in place of the absent representative. Each Party would bear its own costs with respect to its participation on the JMC. (e) The JMC would only act unanimously. If, however, the JMC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred addition to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not Products so long as Hydro Med is able to resolve any satisfy all of its manufacturing obligations to Xxxxxxx hereunder. In such matter case, Hydro Med agrees not to favor such other products, goods or items by consensus within [***] days following referralmanufacturing such products, Ikaria’s Executive Officer shall have goods or items at the right Plant in a manner which has a material adverse effect on Hydro Med's ability to decide manufacture the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8Product at the Plant.