Common use of MARKETING & DISTRIBUTION Clause in Contracts

MARKETING & DISTRIBUTION. a) The LICENSEE shall market, at its own expense, each PRODUCT in the TERRITORY within six (6) months upon receipt of all corresponding REGISTRATIONS necessary for commercialization. b) The LICENSEE shall use commercially reasonable efforts to continuously increase the sale of the PRODUCT(S) in the TERRITORY during the term of this AGREEMENT so long as KREUSSLER supplies PRODUCT(S) to the LICENSEE in accordance with the terms of this AGREEMENT. Provided that i) the LICENSEE shall not be required to use any level of efforts to sell, market, or distribute the PRODUCT(S) in the TERRITORY prior to receipt of all REGISTRATIONS reasonably deemed by the LICENSEE to be necessary for the marketing and sale of the PRODUCT(S) in the TERRITORY; and ii) whether certain efforts by the LICENSEE are deemed to be “commercially reasonable” with respect to the PRODUCT(S) shall be determined in light of all relevant factors in the relevant TERRITORY including, but not limited to: (a) the LICENSEE’S reasonable estimate of the market potential and rate of market growth of the PRODUCT(S) (including anticipated profit margin and the perceived market size); (b) the level of REGISTRATION for the PRODUCT(S) in the TERRITORY (including the extent of the indications, if any, within the TERRITORY); (c) in the LICENSEE’S reasonable estimation, whether or not the sale of the PRODUCT(S) infringes or could infringe the patent rights of third persons in the TERRITORY; (d) the competitive position of the PRODUCT(S) vis-à-vis other products that may be marketed and sold for the treatment of the same indications, including with respect to the safety, efficacy, and cost of the PRODUCT(S) when compared to such other products; and (e) the availability and supply of the PRODUCT(S) for distribution. c) Upon KREUSSLER’S request, and in six (6) calendar month intervals, beginning with the receipt of all necessary REGISTRATIONS, the LICENSEE shall submit to KREUSSLER a half-year report on the marketing of each PRODUCT including, competition, regulatory trends, and pricing trends. d) Upon KREUSSLER’S request and beginning with the marketing of each PRODUCT, the LICENSEE shall report, in electronic format, the sales figures for each PRODUCT in quantity and value and, to the extent available, any price change (ex factory, per batch, prices to different customer-groups and, if applicable, price of reimbursement) within the forty five (45) days after the end of each QUARTER. e) The LICENSEE shall promote the PRODUCT(S) in accordance with all laws and regulations of the TERRITORY and in conformity with KREUSSLER’s guidance as to the use (indications, contraindications etc.) of the PRODUCT(S). Subject to all applicable laws in the TERRITORY, the LICENSEE will retain the rights to produce all clinical education, physician and patient marketing materials the LICENSEE deems to be necessary and advisable for the commercialization of the PRODUCT(S) in the TERRITORY. In order to ascertain the compliance with KREUSSLER’s global marketing policy for the PRODUCT(S), the parties will work together to create a marketing claims overview document, which outlines, subject to applicable laws and regulations, the claims that the LICENSEE will be allowed to make with respect to the marketing of the PRODUCT(S). f) Without prejudice to the LICENSEE’s obligation to verify that promotion of the PRODUCT(S) is in accordance with all laws and regulations of the TERRITORY, KREUSSLER, upon the LICENSEE’S request, shall provide to the LICENSEE scientific and medical data and brochures related to the PRODUCT(S). Such materials will be made available to the LICENSEE at KREUSSLER’s cost to manufacture such materials. g) KREUSSLER shall during the term hereof also inform, from time to time, the LICENSEE of its newest medical-scientific data with respect to the PRODUCT(S). Furthermore, KREUSSLER shall, from time to time, contact the LICENSEE orally or in writing to inform them of KREUSSLER’S experiences in the marketing and selling of the PRODUCT(S) and assist the LICENSEE in the instructions of the medical representatives/sales force by submitting relevant documentation, it being understood that such instruction of the medical representatives shall be based on the documentation handed over in connection with the REGISTRATION. h) The LICENSEE shall store and distribute the PRODUCT(S) in accordance with all applicable laws and regulations of the TERRITORY, including applicable warehousing and distribution procedures set forth in 21 CFR Part 211, Subpart H, and, in addition, in conformity with standard industry practices. KREUSSLER shall have the right to have its representatives present at the plant or plants at which PRODUCT(S) are stored and shipped and other activities under this AGREEMENT are performed during normal business hours to conduct an initial and periodic inspections of such facilities and storage, marketing, shipping, distribution and pharmacovigilance procedures for compliance with applicable laws, regulations and standards including those set forth in Article III (h) and Article V (e) and (h), and to inspect the LICENSEE’S inventory of PRODUCT(S), order/shipping records, quality manuals, regulatory dossiers, and such other matters as may be pertinent to ensure proper quality assurance of PRODUCT(S) to be stored, marketed, shipped and distributed hereunder; it being understood that the parties do not expect more than one (1) inspection (up to two (2) days) every second year, unless required by the LICENSEE’S or its AFFILIATE’S compliance status. KREUSSLER agrees to give the LICENSEE a minimum of twenty (20) business days prior notice of any such inspection. The LICENSEE shall promptly use its best efforts to take such action as is required to correct any deficiencies identified by KREUSSLER and accepted by the LICENSEE relating to LICENSEE’S obligations concerning the PRODUCT(S). The LICENSEE further agrees to use its best efforts to provide such documentation or conduct such measures as KREUSSLER may reasonably request in connection with any regulatory submission or audit. At KREUSSLER’S reasonable request, the LICENSEE will perform a quality system assessment of the AFFILIATE(s), Sub-Licensee(s) or other contractor(s) involved in connection with the storage, marketing, shipment and distribution of the PRODUCT(S) and the LICENSEE shall promptly notify the KREUSSLER of the results of such assessments.

MARKETING & DISTRIBUTION. a) The LICENSEE shall market, at its own expense, each PRODUCT in the TERRITORY within six (6) months [****] upon receipt of all corresponding REGISTRATIONS necessary for commercialization. b) The LICENSEE shall use commercially reasonable efforts to continuously increase the sale of the PRODUCT(S) in the TERRITORY during the term of this AGREEMENT so long as KREUSSLER supplies PRODUCT(S) to the LICENSEE in accordance with the terms of this AGREEMENT. Provided that i) the LICENSEE shall not be required to use any level of efforts to sell, market, or distribute the PRODUCT(S) in the TERRITORY prior to receipt of all REGISTRATIONS reasonably deemed by the LICENSEE to be necessary for the marketing and sale of the PRODUCT(S) in the TERRITORY; and ii) whether certain efforts by the LICENSEE are deemed to be “commercially reasonable” with respect to the PRODUCT(S) shall be determined in light of all relevant factors in the relevant TERRITORY including, but not limited to: (a) the LICENSEE’S reasonable estimate of the market potential and rate of market growth of the PRODUCT(S) (including anticipated profit margin and the perceived market size);; **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) the level of REGISTRATION for the PRODUCT(S) in the TERRITORY (including the extent of the indications, if any, within the TERRITORY); (c) in the LICENSEE’S reasonable estimation, whether or not the sale of the PRODUCT(S) infringes or could infringe the patent rights of third persons in the TERRITORY; (d) the competitive position of the PRODUCT(S) vis-à-vis other products that may be marketed and sold for the treatment of the same indications, including with respect to the safety, efficacy, and cost of the PRODUCT(S) when compared to such other products; and (e) the availability and supply of the PRODUCT(S) for distribution. c) Upon KREUSSLER’S request, and in six (6) calendar month intervals, beginning with the receipt of all necessary REGISTRATIONS, the LICENSEE shall submit to KREUSSLER a half-year report on the marketing of each PRODUCT including, competition, regulatory trends, and pricing trends. d) Upon KREUSSLER’S request and beginning with the marketing of each PRODUCT, the LICENSEE shall report, in electronic format, the sales figures for each PRODUCT in quantity and value and, to the extent available, any price change (ex factory, per batch, prices to different customer-groups and, if applicable, price of reimbursement) within the forty five (45) days after the end of each QUARTER. e) The LICENSEE shall promote the PRODUCT(S) in accordance with all laws and regulations of the TERRITORY and in conformity with KREUSSLER’s guidance as to the use (indications, contraindications etc.) of the PRODUCT(S). Subject to all applicable laws in the TERRITORY, the LICENSEE will retain the rights to produce all clinical education, physician and patient marketing materials the LICENSEE deems to be necessary and advisable for the commercialization of the PRODUCT(S) in the TERRITORY. In order to ascertain the compliance with KREUSSLER’s global marketing policy for the PRODUCT(S), the parties will work together to create a marketing claims overview document, which outlines, subject to applicable laws and regulations, the claims that the LICENSEE will be allowed to make with respect to the marketing of the PRODUCT(S). f) Without prejudice to the LICENSEE’s obligation to verify that promotion of the PRODUCT(S) is in accordance with all laws and regulations of the TERRITORY, KREUSSLER, upon the LICENSEE’S request, shall provide to the LICENSEE scientific and medical data and brochures related to the PRODUCT(S). Such materials will be made available to the LICENSEE at KREUSSLER’s cost to manufacture such materials. g) KREUSSLER shall during the term hereof also inform, from time to time, the LICENSEE of its newest medical-scientific data with respect to the PRODUCT(S). Furthermore, KREUSSLER shall, from time to time, contact the LICENSEE orally or in writing to inform them of KREUSSLER’S experiences in the marketing and selling of the PRODUCT(S) and assist the LICENSEE in the instructions of the medical representatives/sales force by submitting relevant documentation, it being understood that such instruction of the medical representatives shall be based on the documentation handed over in connection with the REGISTRATION. h) The LICENSEE shall store and distribute the PRODUCT(S) in accordance with all applicable laws and regulations of the TERRITORY, including applicable warehousing and distribution procedures set forth in 21 CFR Part 211, Subpart H, and, in addition, in conformity with standard industry practices. KREUSSLER shall have the right to have its representatives present at the plant or plants at which PRODUCT(S) are stored and shipped and other activities under this AGREEMENT are performed during normal business hours to conduct an initial and periodic inspections of such facilities and storage, marketing, shipping, distribution and pharmacovigilance procedures for compliance with applicable laws, regulations and standards including those set forth in Article III (h) and Article V (e) and (h), and to inspect the LICENSEE’S inventory of PRODUCT(S), order/shipping records, quality manuals, regulatory dossiers, and such other matters as may be pertinent to ensure proper quality assurance of PRODUCT(S) to be stored, marketed, shipped and distributed hereunder; it being understood that the parties do not expect more than one (1) inspection (up to two (2) days) every second year, unless required by the LICENSEE’S or its AFFILIATE’S compliance status. KREUSSLER agrees to give the LICENSEE a minimum of twenty (20) business days prior notice of any such inspection. The LICENSEE shall promptly use its best efforts to take such action as is required to correct any deficiencies identified by KREUSSLER and accepted by the LICENSEE relating to LICENSEE’S obligations concerning the PRODUCT(S). The LICENSEE further agrees to use its best efforts to provide such documentation or conduct such measures as KREUSSLER may reasonably request in connection with any regulatory submission or audit. At KREUSSLER’S reasonable request, the LICENSEE will perform a quality system assessment of the AFFILIATE(s), Sub-Licensee(s) or other contractor(s) involved in connection with the storage, marketing, shipment and distribution of the PRODUCT(S) and the LICENSEE shall promptly notify the KREUSSLER of the results of such assessments.