Common use of COMMERCIALISATION OBLIGATIONS Clause in Contracts

COMMERCIALISATION OBLIGATIONS. 6.1. Subject to a different decision by the Contract Governance Committee, Bayer shall commence sales of the Products within six (6) months of the grant of Marketing Authorisation for the Products in the UK Territory and within six (6) months of the fulfilment of the Launch Conditions in other countries within the Territory, provided, however, that Bayer was in receipt of Launch stocks of the Products as provided by the Supply Agreement in sufficient time prior to the commencement of sales in accordance with this Clause 6.1 and that Bayer had obtained any other approval required from a Governmental Authority (including without limitation a Controlled Drugs Authority) required to sell the Products in the Territory on a commercial basis. 6.2. The Parties shall establish within five (5) business days of the Effective Date in the case of the UK Territory and before 30 September 2003 in the case of each country added to the Territory under the Territory Option Procedure a Country Commercialisation Committee in each country within the Territory. Each Country Commercialisation Committee shall meet upon request by either Party until one (1) year after the Launch on at least a quarterly basis and thereafter on at least a bi-annual basis. In the event of a dispute within a Country Commercialisation Committee, the dispute (except with respect to disputes relating to setting the Sales Targets (as defined below) whereby disputes in relation thereto shall be settled by the procedure set out in Clause 17) will first be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the dispute within thirty (30) days from the date that written notice initiating this resolution process is sent to the other Party. In the event that the Contract Governance Committee cannot resolve the dispute, the decision of Bayer shall be final. The duties of each Country Commercialisation Committee shall include the setting and monitoring in good faith of appropriate and reasonable sales performance levels for the country in question for each agreed twelve (12) month sales period (“Sales Targets”). 6.3. Bayer shall use all reasonable endeavours to meet the Sales Targets. 6.4. Without prejudice to Clause 6.3 above, Bayer shall and shall procure that its Affiliates market and promote the Products using such efforts as Bayer would use for a product of its own making which has the same technical, regulatory and commercial potential to the Products having reasonable regard at all times to the stage at which the relevant Product has reached in its life cycle and the time that has elapsed since Launch; the number of years remaining to loss of exclusivity; competing products; the regulatory environment and reimbursement status of the Products. Such marketing and promotion shall be in accordance with the valid Marketing Authorisations and any variations thereof applicable from time to time and all applicable Laws in each country of the Territory. 6.5. Without prejudice and subject to Clauses 6.2 to 6.4 inclusive above, Bayer and its Affiliates shall maintain sufficient resources (either its own employees or through permitted sub-contractors) during the term of this Agreement to detail, sell, distribute and promote the sale of the Products in the Territory. 6.6. In the event that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory, GW shall raise and reasonably substantiate GW’s complaint within the Country Commercialisation Committee. If such discussion cannot be resolved within the Country Commercialisation Committee, it will be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the discussion within thirty (30) days from the date that it was notified accordingly. In the event that the Contract Governance Committee cannot resolve the discussion and that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory, the following shall apply: In the event that (a) Bayer did not achieve in the preceding *** month period prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales levels throughout the countries concerned of at least *** percent (***%) of those Net Sales achieved by Bayer in the *** month period immediately prior to the *** month period specified above, and (b) GW can demonstrate to Bayer’s reasonable satisfaction that such sales development has not been caused by reasons out of Bayer’s or its Affiliate’s control, each and every of the licences and rights granted under this Agreement for such country shall become non-exclusive immediately upon written notice by GW to Bayer to this effect. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. In the event that in each of the *** month periods prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales throughout the countries concerned amount to *** percent (***%) or less of the total Net Sales achieved by Bayer in the consecutive *** month periods immediately preceding each of such periods and GW can demonstrate to Bayer’s reasonable satisfaction that this event has not been caused by reasons out of Bayer’s control each and every of the licences and rights granted under this Agreement for such country shall terminate upon written notice by GW to Bayer with immediate effect. For avoidance of doubt, it is understood between the Parties that the foregoing does not apply in the event of *** month period *** month periods. 6.7. Bayer agrees during the term of this Agreement to comply with, and not to take any action which would be subject to penalty under all Laws applicable to this Agreement in any country within the Territory, and to conduct its business in accordance with all applicable ethical business practices and Good Distribution Practice. 6.8. Bayer shall at its own cost and expense be responsible for all the preparation and certification of Promotional Materials and marketing, advertising and promoting of the Products in the Territory. Bayer shall provide to GW, through the mechanism of the Country Commercialisation Committee, draft documents containing the key promotional messages forming the basis of Bayer’s core marketing claims at an early stage in Bayer’s preparation of its core marketing claims having regard to GW’s position and responsibilities as Marketing Authorisation holder and in the event of a dispute between the Parties the procedure in Clause 17 below shall apply. The Products, packaging materials and Promotional Materials based on the foregoing key promotional messages shall properly and clearly state that such are sold under license from GW and prior to release in a country of the Territory the finalised Promotional Materials will have been approved in writing by the relevant Country Commercialisation Committee. Bayer shall provide copies of the finalised Promotional Materials to GW as soon as possible. GW will provide Bayer or its Affiliates SmPC text revisions as timely as possible to allow preparation of promotional materials. 6.9. Without prejudice to the provisions of Clause 6.7 above, Bayer shall ensure that no claims or representations in respect of the Products or the characteristics thereof are made by or on behalf of it (by its agents or subcontractors or otherwise) which do not represent an accurate summary or explanation of the labelling of the Products or SmPC or a portion thereof. 6.10. Bayer shall comply in all material respects with applicable Laws in each country of the Territory (including without limitation with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice and all regulations under the Medicines ▇▇▇ ▇▇▇▇ (as amended)) in its promotional activities in relation to the Products. 6.11. Bayer shall not actively seek customers outside the Territory in connection with the Products.

COMMERCIALISATION OBLIGATIONS. 6.1. Subject to a different decision by the Contract Governance Committee, Bayer shall commence sales of the Products within six (6) months of the grant of Marketing Authorisation for the Products in the UK Territory and within six (6) months of the fulfilment of the Launch Conditions in other countries within the Territory, provided, however, that Bayer was in receipt of Launch stocks of the Products as provided by the Supply Agreement in sufficient time prior to the commencement of sales in accordance with this Clause 6.1 and that Bayer had obtained any other approval required from a Governmental Authority (including without limitation a Controlled Drugs Authority) required to sell the Products in the Territory on a commercial basis. 6.2. The Parties shall establish within five (5) business days of the Effective Date in the case of the UK Territory and before 30 September 2003 in the case of each country added to the Territory under the Territory Option Procedure a Country Commercialisation Committee in each country within the Territory. Each Country Commercialisation Committee shall meet upon request by either Party until one (1) year after the Launch on at least a quarterly basis and thereafter on at least a bi-annual basis. In the event of a dispute within a Country Commercialisation Committee, the dispute (except with respect to disputes relating to setting the Sales Targets (as defined below) whereby disputes in relation thereto shall be settled by the procedure set out in Clause 17) will first be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the dispute within thirty (30) days from the date that written notice initiating this resolution process is sent to the other Party. In the event that the Contract Governance Committee cannot resolve the dispute, the decision of Bayer shall be final. The duties of each Country Commercialisation Committee shall include the setting and monitoring in good faith of appropriate and reasonable sales performance levels for the country in question for each agreed twelve (12) month sales period (“Sales Targets”). 6.3. Bayer shall use all reasonable endeavours to meet the Sales Targets. 6.4. Without prejudice to Clause 6.3 above, Bayer shall and shall procure that its Affiliates market and promote the Products using such efforts as Bayer would use for a product of its own making which has the same technical, regulatory and commercial potential to the Products having reasonable regard at all times to the stage at which the relevant Product has reached in its life cycle and the time that has elapsed since Launch; the number of years remaining to loss of exclusivity; competing products; the regulatory environment and reimbursement status of the Products. Such marketing and promotion shall be in accordance with the valid Marketing Authorisations and any variations thereof applicable from time to time and all applicable Laws in each country of the Territory. 6.5. Without prejudice and subject to Clauses 6.2 to 6.4 inclusive above, Bayer and its Affiliates shall maintain sufficient resources (either its own employees or through permitted sub-contractors) during the term of this Agreement to detail, sell, distribute and promote the sale of the Products in the Territory. 6.6. In the event that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory, GW shall raise and reasonably substantiate GW’s complaint within the Country Commercialisation Committee. If such discussion cannot be resolved within the Country Commercialisation Committee, it will be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the discussion within thirty (30) days from the date that it was notified accordingly. In the event that the Contract Governance Committee cannot resolve the discussion and that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory, the following shall apply: In the event that (a) Bayer did not achieve in the preceding *** month period prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales levels throughout the countries concerned of at least *** percent (***%) of those Net Sales achieved by Bayer in the *** month period immediately prior to the *** month period specified above, and (b) GW can demonstrate to Bayer’s reasonable satisfaction that such sales development has not been caused by reasons out of Bayer’s or its Affiliate’s control, each and every of the licences and rights granted under this Agreement for such country shall become non-exclusive immediately upon written notice by GW to Bayer to this effect. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. In the event that in each of the *** month periods prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales throughout the countries concerned amount to *** percent (***%) or less of the total Net Sales achieved by Bayer in the consecutive *** month periods immediately preceding each of such periods and GW can demonstrate to Bayer’s reasonable satisfaction that this event has not been caused by reasons out of Bayer’s control each and every of the licences and rights granted under this Agreement for such country shall terminate upon written notice by GW to Bayer with immediate effect. For avoidance of doubt, it is understood between the Parties that the foregoing does not apply in the event of *** month period *** month periods. 6.7. Bayer agrees during the term of this Agreement to comply with, and not to take any action which would be subject to penalty under all Laws applicable to this Agreement in any country within the Territory, and to conduct its business in accordance with all applicable ethical business practices and Good Distribution Practice. 6.8. Bayer shall at its own cost and expense be responsible for all the preparation and certification of Promotional Materials and marketing, advertising and promoting of the Products in the Territory. Bayer shall provide to GW, through the mechanism of the Country Commercialisation Committee, draft documents containing the key promotional messages forming the basis of Bayer’s core marketing claims at an early stage in Bayer’s preparation of its core marketing claims having regard to GW’s position and responsibilities as Marketing Authorisation holder and in the event of a dispute between the Parties the procedure in Clause 17 below shall apply. The Products, packaging materials and Promotional Materials based on the foregoing key promotional messages shall properly and clearly state that such are sold under license from GW and prior to release in a country of the Territory the finalised Promotional Materials will have been approved in writing by the relevant Country Commercialisation Committee. Bayer shall provide copies of the finalised Promotional Materials to GW as soon as possible. GW will provide Bayer or its Affiliates SmPC text revisions as timely as possible to allow preparation of promotional materials. 6.9. Without prejudice to the provisions of Clause 6.7 above, Bayer shall ensure that no claims or representations in respect of the Products or the characteristics thereof are made by or on behalf of it (by its agents or subcontractors or otherwise) which do not represent an accurate summary or explanation of the labelling of the Products or SmPC or a portion thereof. 6.10. Bayer shall comply in all material respects with applicable Laws in each country of the Territory (including without limitation with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice and all regulations under the Medicines ▇▇▇ ▇▇▇▇ (as amended)) in its promotional activities in relation to the Products. 6.11. Bayer shall not actively seek customers outside the Territory in connection with the Products.