Common use of Product Positioning Strategy Clause in Contracts

Product Positioning Strategy. Given the current expectations of the product profile, we aspire to — and expect that — BL-1040 will be positioned as the de facto standard for prevention of post-MI remodeling. While this depends on the specific results of the clinical trials, the market conditions, including competitive scenario, and prevailing clinical practice standards, the goal will be to make BL-1040 use prevalent across a range of patient sub-groups that are at risk for remodeling. Specifically, the following patient groups will be addressed in the marketing plan: · High-risk STEMI (includes patients with large myocardial Infarctions (MIs), anterior wall MIs and long lead time to PCI): [**] · Other STEMI (includes all STEMI patients not considered of the highest risk): [**] · NSTEMI (all patients who have an NSTEMI): [**] In addition to the market development efforts listed above, the focus of marketing strategy will be on creating broad awareness of the significant long-term effects of remodeling as well as discussing the risks of myocardial damage and resulting negative consequences for all patients with MIs. In Europe, this will also require resetting of the current paradigm of treating non-primary PCI patients with medical therapy alone, and illustrating the benefits of treatment with a mechanical scaffolding device such as BL-1040. As an experienced critical care company, Ikaria is committed to providing doctors and other medical professionals with a high level of customer service. Operating in a highly specialized, life-or-death environment Ikaria strives to match our customers own urgency and commitment to patient care. To be successful in the area of post-MI care we anticipate creating an organization capable of delivering both the commercial and medical support desired by our target customer base. Ikaria intends to establish itself as the leader in critical care globally, and will use BL-1040 as the platform on which to establish its international presence. As such, we intend to build a robust but flexible organization with all the competencies necessary to achieve leadership of the field. Although BL-1040 will likely be Ikaria’s first global product, we anticipate that our own internal pipeline candidates IK-1001 and Covox will not be far behind. The infrastructure envisioned by Ikaria and described in this document will therefore be sufficient to successfully commercialize all of Ikaria’s present and future pipeline compounds. Ikaria proposed to use a “hub and spoke” approach to commercializing BL-1040 in Europe—the “hub” being a European headquarters and the “spokes” representing local operating companies (LOCs) in major markets. The headquarters will provide overall strategic leadership and will spearhead European product development and commercial strategy, while local operating companies will be responsible for selling activity and local tactic implementation. In addition to strategic marketing and leadership support, the European headquarters will be responsible for financial management and reporting of regional results, management of European regulatory affairs functions, development of a European clinical development program, development of effective key opinion leadership, development of compelling health economic data and development of HR strategies to maintain a strong and vibrant European organization. The primary role of LOCs is to provide the necessary local sales and marketing efforts necessary to achieve financial objectives for BL-1040. In addition to the necessary commercial infrastructure, the local operating companies would also be staffed with the support functions essential to commercial success. This would include a small local finance team, medical affairs, regulatory affairs and human resource functions. The role of the local support staff is to implement strategic initiatives conceived at headquarters level, and support local initiatives as necessary. The medical affairs staff will be particularly important in supporting marketing in disseminating the full medical information on BL-1040 and the clinical specialists will also lead the training of physicians in using this product appropriately. The LOC staffing level will be determined as a function of country population, disease prevalence and target doctor population. Sales Representatives will be recruited from companies with a depth of experience in cardiovascular drug and device sales to ensure we gain rapid access to the necessary prescriber base. Representatives will be compensated through a blend of base salary and sales incentive bonus, according to Ikaria’s existing sales force incentive plan. (See Table 2) [**] 10.4 34.7 230 28 [**] [**] 5.5 18.3 85 15 [**] [**] 5.3 17.7 80 14 [**] [**] 64.4 214.7 1,772 172 [**] [**] 82.3 274.3 1,500 219 [**] [**] 16.7 55.7 266 45 [**] [**] 0.3 1.0 14 1 [**] [**] 58.1 193.7 1,879 155 [**] [**] 40.5 135.0 730 108 [**] [**] 7.6 25.3 124 20 [**] [**] 61.1 203.7 1,000 163 [**] Total Europe 352.2 1,174.0 7,682 939 [**] [**] 127.0 423.3 2,500 339 [**] [**] 21.0 70.0 373 56 [**] Grand Total 479.2 1,597.3 10,182 1,278 [**] NB: The number of sales reps anticipated to be needed in each market has been estimated as a function of [**]

Product Positioning Strategy. Given the current expectations of the product profile, we aspire to — – and expect that — – BL-1040 will be positioned as the de facto standard for prevention of post-MI remodeling. While this depends on the specific results of the clinical trials, the market conditions, including competitive scenario, and prevailing clinical practice standards, the goal will be to make BL-1040 use prevalent across a range of patient sub-groups that are at risk for remodeling. Specifically, the following patient groups will be addressed in the marketing plan: · ■ High-risk STEMI (includes patients with large myocardial Infarctions (MIs), anterior wall MIs and long lead time to PCI): [***] · ■ Other STEMI (includes all STEMI patients not considered of the highest risk): [***] · ■ [***] ■ NSTEMI (all patients who have an NSTEMI): [***] In addition to the market development efforts listed above, the focus of marketing strategy will be on creating broad awareness of the significant long-term effects of remodeling as well as discussing the risks of myocardial damage and resulting negative consequences for all patients with MIs. In Europe, this will also require resetting of the current paradigm of treating non-primary PCI patients with medical therapy alone, and illustrating the benefits of treatment with a mechanical scaffolding device such as BL-1040. As an experienced critical care company, Ikaria is committed to providing doctors and other medical professionals with a high level of customer service. Operating in a highly specialized, life-or-death environment Ikaria strives to match our customers own urgency and commitment to patient care. To be successful in the area of post-MI care we anticipate creating an organization capable of delivering both the commercial and medical support desired by our target customer base. Ikaria intends to establish itself as the leader in critical care globally, and will use BL-1040 as the platform on which to establish its international presence. As such, we intend to build a robust but flexible organization with all the competencies necessary to achieve leadership of the field. Although BL-1040 will likely be Ikaria’s first global product, we anticipate that our own internal pipeline candidates IK-1001 and Covox will not be far behind. The infrastructure envisioned by Ikaria and described in this document will therefore be sufficient to successfully commercialize all of Ikaria’s present and future pipeline compounds. Ikaria proposed to use a “hub and spoke” approach to commercializing BL-1040 in Europe—the “hub” being a European headquarters and the “spokes” representing local operating companies (LOCs) in major markets. The headquarters will provide overall strategic leadership and will spearhead European product development and commercial strategy, while local operating companies will be responsible for selling activity and local tactic implementation. In addition to strategic marketing and leadership support, the European headquarters will be responsible for financial management and reporting of regional results, management of European regulatory affairs functions, development of a European clinical development program, development of effective key opinion leadership, development of compelling health economic data and development of HR strategies to maintain a strong and vibrant European organization. The primary role of LOCs is to provide the necessary local sales and marketing efforts necessary to achieve financial objectives for BL-1040. In addition to the necessary commercial infrastructure, the local operating companies would also be staffed with the support functions essential to commercial success. This would include a small local finance team, medical affairs, regulatory affairs and human resource functions. The role of the local support staff is to implement strategic initiatives conceived at headquarters level, and support local initiatives as necessary. The medical affairs staff will be particularly important in supporting marketing in disseminating the full medical information on BL-1040 and the clinical specialists will also lead the training of physicians in using this product appropriately. The LOC staffing level will be determined as a function of country population, disease prevalence and target doctor population. Sales Representatives will be recruited from companies with a depth of experience in cardiovascular drug and device sales to ensure we gain rapid access to the necessary prescriber base. Representatives will be compensated through a blend of base salary and sales incentive bonus, according to Ikaria’s existing sales force incentive plan. (See Table 2) Table 2 [***] 10.4 34.7 230 28 [***] [***] 5.5 18.3 85 15 [***] [***] 5.3 17.7 80 14 [***] [***] 64.4 214.7 1,772 172 [***] [***] 82.3 274.3 1,500 219 [***] [***] 16.7 55.7 266 45 [***] [***] 0.3 1.0 14 1 [***] [***] 58.1 193.7 1,879 155 [***] [***] 40.5 135.0 730 108 [***] [***] 7.6 25.3 124 20 [***] [***] 61.1 203.7 1,000 163 [***] Total Europe 352.2 1,174.0 7,682 939 [***] [***] 127.0 423.3 2,500 339 [***] [***] 21.0 70.0 373 56 [***] Grand Total 479.2 1,597.3 10,182 1,278 [***] NB: The number of sales reps anticipated to be needed in each market has been estimated as a function of [***].