Common use of Marketing and Sales Activities Clause in Contracts

Marketing and Sales Activities. 5.1 Merck will perform all industry-standard and customary pre-marketing activities […***…] prior to the envisaged LAUNCH of the PRODUCT. 5.2 Merck will use its commercially reasonable efforts to market the PRODUCTS comparable to the common practice of the industry for products of a comparable market size. In any event, but subject to Section 4.2, Merck will launch the PRODUCT in the TERRITORY no later than […***…] following transfer of the MARKETING AUTHORIZATION to Merck by Nitec Germany hereunder, price approval and other official approvals, to the extent that these approvals are a condition for so launching PRODUCT. 5.3 Merck agrees that all material used in connection with the promotion and distribution of the PRODUCT shall comply with the applicable law and any information contained in such material shall be consistent with the MARKETING AUTHORIZATION. The marketing plan of the PRODUCT for the following year shall be presented and provided to Nitec AG during the fourth quarter of each year. 5.4 No written or printed material relating to the PRODUCT shall be used by Merck without Nitec AG’s prior written consent. Any information on written or printed materials provided to Nitec shall be subject to Article 12. If within […***…] business days after receipt of such material, Nitec AG or Nitec Germany does not inform Merck, that it objects to the presented materials or, if Nitec AG or Nitec Germany, in case of objections, within […***…] more working days do not inform Merck in writing of the reasons for the objection, such material shall be considered approved by Nitec AG. The consent of Nitec AG may not be unreasonably withheld. Merck shall not initiate and/or conduct any Phase III/IV clinical studies for the PRODUCT without Nitec AG’s prior written consent. 5.5 Each Party will provide the other free of charge with the results of its market research activities for the PRODUCT in the TERRITORY. Additionally, Nitec AG shall provide Merck with all results obtained by studies conducted by or on behalf of Nitec AG in relation to the indication rheumatoid arthritis. 5.6 Within […***…] days following each calendar quarter, Merck shall send to Nitec a copy of the Merck’s internal sales report covering the preceding quarter. Each such quarterly sales report shall show the total distribution of the PRODUCT (sales) in units and values for each dosage form. The sales report shall include separate figures for wholesaler and hospital supply. During the twelve (12) month period starting with the first commercial introduction Merck will provide Nitec AG monthly sales (in units and values). Each Party shall inform the other Party of any proposed and/or approved regulations and/or laws which could influence the sales of the PRODUCT 5.7 Should Merck not reach TARGET SALES or, respectively, the ANNUAL MINIMUM SALES as agreed upon same shall not be regarded as a breach of this AGREEMENT. Upon such occurrence representatives of both Parties shall propose measures to reach the TARGET SALES. The evaluation of achieved versus TARGET SALES will be performed every […***…] months. 5.8 Should ANNUAL MINIMUM SALES not be reached in any […***…] (the first such period to commence upon LAUNCH) during the TERM due to reasons not attributable to Nitec and/or the third party manufacturer, and same shall not be remedied within […***…] after respective notice by Nitec to Merck, Nitec’s exclusive remedy shall be the right to make use of the Duplicate Authorization, as defined in No. 6 of the Preamble effective as of the end of the […***…] period and to introduce or to have introduced a product in the TERRITORY under such duplicate authorization. In such a case, the continuation of this AGREEMENT shall not be subject to any ANNUAL MINIMUM SALES. 5.9 For the purposes of Art. 5.6 and 5.7, the sales of the PRODUCT in the TERRITORY by Merck shall be those reported by IMS or by any other source mutually agreed by the Parties offering a service similar to the one currently offered by IMS.

Marketing and Sales Activities. 5.1 Merck will perform all industry-standard and customary pre-marketing activities […***…] prior to the envisaged LAUNCH of the PRODUCT. 5.2 Merck will use its commercially reasonable efforts to market the PRODUCTS comparable to the common practice of the industry for products of a comparable market size. In any event, but subject to Section 4.2, Merck will launch the PRODUCT in the TERRITORY no later than […***…] following transfer of the MARKETING AUTHORIZATION to Merck by Nitec Germany hereunder, price approval and other official approvals, to the extent that these approvals are a condition for so launching PRODUCT. 5.3 Merck agrees that all material used in connection with the promotion and distribution of the PRODUCT shall comply with the applicable law and any information contained in such material shall be consistent with the MARKETING AUTHORIZATION. The marketing plan of the PRODUCT for the following year shall be presented and provided to Nitec AG during the fourth quarter of each year. 5.4 No written or printed material relating to the PRODUCT shall be used by Merck without Nitec AG’s prior written consent. Any information on written or printed materials provided to Nitec AG shall be subject to Article 12. If within […***…] five (5) business days after receipt of such material, Nitec AG or Nitec Germany does not inform Merck, that it objects to the presented materials or, if Nitec AG or Nitec Germany, in case of objections, within […***…] five (5) more working days do not inform Merck in writing of the reasons for the objection, such material shall be considered approved by Nitec AG. The consent of Nitec AG may not be unreasonably withheld. Merck shall not initiate and/or conduct any Phase III/IV clinical studies for the PRODUCT without Nitec AG’s prior written consent. 5.5 Each Party will provide the other free of charge with the results of its market research activities for the PRODUCT in the TERRITORY. Additionally, Nitec AG shall provide Merck with all results obtained by studies conducted by or on behalf of Nitec AG in relation to the indication rheumatoid arthritis. 5.6 Within […***…] days following each calendar quarter, Merck shall send to Nitec a copy of the Merck’s internal sales report covering the preceding quarter. Each such quarterly sales report shall show the total distribution of the PRODUCT (sales) in units and values for each dosage form. The sales report shall include separate figures for wholesaler and hospital supply. During the twelve (12) month period starting with the first commercial introduction Merck will provide Nitec AG monthly sales (in units and values). Each Party shall inform the other Party of any proposed and/or approved regulations and/or laws which could influence the sales of the PRODUCT 5.7 Should Merck not reach TARGET SALES or, respectively, the ANNUAL MINIMUM SALES as agreed upon same shall not be regarded as a breach of this AGREEMENT. Upon such occurrence representatives of both Parties shall propose measures to reach the TARGET SALES. The evaluation of achieved versus TARGET SALES will be performed every […***…] months. 5.8 Should ANNUAL MINIMUM SALES not be reached in any […***…] (the first such period to commence upon LAUNCH) during the TERM due to reasons not attributable to Nitec and/or the third party manufacturer, and same shall not be remedied within […***…] after respective notice by Nitec to Merck, Nitec’s exclusive remedy shall be . Nitec reserves the right to make use terminate this AGREEMENT. Prior to such termination, however, representatives of the Duplicate Authorization, as defined both Parties shall discuss in No. 6 of the Preamble effective as of the end of the […***…] period and to introduce or to have introduced a product good faith whether this AGREEMENT could be modified in the TERRITORY under such duplicate authorization. In such a case, the continuation best interest of this AGREEMENT shall not be subject to any ANNUAL MINIMUM SALESboth parties. 5.9 For the purposes of Art. 5.6 and 5.7, the sales of the PRODUCT in the TERRITORY by Merck shall be those reported by IMS or by any other source mutually agreed by the Parties offering a service similar to the one currently offered by IMS. Monthly hospital sales reported by Merck during the twelve (12) month period starting with the first commercial introduction will be based on Merck data solely, since no comparable data exist with IMS or other sources.

Marketing and Sales Activities. 5.1 Merck will perform all industry-standard and customary pre-marketing activities […***…] prior to the envisaged LAUNCH of the PRODUCT. 5.2 Merck will use its commercially reasonable efforts to market the PRODUCTS comparable to the common practice of the industry for products of a comparable market size. In any event, but subject to Section 4.2, Merck will launch the PRODUCT in the TERRITORY no later than […***…] following transfer of the MARKETING AUTHORIZATION to Merck by Nitec Germany hereunder, price approval and other official approvals, to the extent that these approvals are a condition for so launching PRODUCT. 5.3 Merck agrees that all material used in connection with the promotion and distribution of the PRODUCT shall comply with the applicable law and any information contained in such material shall be consistent with the MARKETING AUTHORIZATION. The marketing plan of the PRODUCT for the following year shall be presented and provided to Nitec AG during the fourth quarter of each year. 5.4 No written or printed material relating to the PRODUCT shall be used by Merck without Nitec AG’s prior written consent. Any information on written or printed materials provided to Nitec shall be subject to Article 12. If within […***…] business days after receipt of such material, Nitec AG or Nitec Germany does not inform Merck, that it objects to the presented materials or, if Nitec AG or Nitec Germany, in case of objections, within […***…] more working days do not inform Merck in writing of the reasons for the objection, such material shall be considered approved by Nitec AG. The consent of Nitec AG may not be unreasonably withheld. Merck shall not initiate and/or conduct any Phase III/IV clinical studies for the PRODUCT without Nitec AG’s prior written consent. 5.5 Each Party will provide the other free of charge with the results of its market research activities for the PRODUCT in the TERRITORY. Additionally, Nitec AG shall provide Merck with all results obtained by studies conducted by or on behalf of Nitec AG in relation to the indication rheumatoid arthritis. 5.6 Within […***…] days following each calendar quarter, Merck shall send to Nitec a copy of the Merck’s internal sales report covering the preceding quarter. ***Confidential Treatment Requested Each such quarterly sales report shall show the total distribution of the PRODUCT (sales) in units and values for each dosage form. The sales report shall include separate figures for wholesaler and hospital supply. During the twelve (12) month period starting with the first commercial introduction Merck will provide Nitec AG monthly sales (in units and values). Each Party shall inform the other Party of any proposed and/or approved regulations and/or laws which could influence the sales of the PRODUCT 5.7 Should Merck not reach TARGET SALES or, respectively, the ANNUAL MINIMUM SALES as agreed upon same shall not be regarded as a breach of this AGREEMENT. Upon such occurrence representatives of both Parties shall propose measures to reach the TARGET SALES. The evaluation of achieved versus TARGET SALES will be performed every […***…] months. 5.8 Should ANNUAL MINIMUM SALES not be reached in any […***…] (the first such period to commence upon LAUNCH) during the TERM due to reasons not attributable to Nitec and/or the third party manufacturer, and same shall not be remedied within […***…] after respective notice by Nitec to Merck, Nitec’s exclusive remedy shall be the right to make use of the Duplicate Authorization, as defined in No. 6 of the Preamble effective as of the end of the […***…] period and to introduce or to have introduced a product in the TERRITORY under such duplicate authorization. In such a case, the continuation of this AGREEMENT shall not be subject to any ANNUAL MINIMUM SALES. 5.9 For the purposes of Art. 5.6 and 5.7, the sales of the PRODUCT in the TERRITORY by Merck shall be those reported by IMS or by any other source mutually agreed by the Parties offering a service similar to the one currently offered by IMS.