Common use of Commercialisation Clause in Contracts

Commercialisation. 5.1 Subject to Clause 5.16, Almirall’s core obligation in relation to Commercialisation of Product shall be to use its Commercially Reasonable Efforts to achieve Launch of the Product for the first Indication within six (6) months after the grant of Marketing Authorisation (including pricing and/or reimbursement approval where such approval is necessary or industry practice for Launch) for Product for that Indication in each Major European Market and in the other countries in the Territory. Thereafter Almirall shall use its Commercially Reasonable Efforts in each Major European Market and in the other countries in the Territory to realise the market potential of Product for that Indication and any subsequent Indication for which GW Pharma obtains a Marketing Authorisation save as provided below: 5.1.1 As soon as Almirall considers that there is no economic case for launching Product in a specific country in the Territory and in any event within six (6) months of Marketing Authorisation for that country being granted, Almirall shall give GW Pharma written notice of this opinion and include evidence in Document form to support this opinion; 5.1.2 If GW Pharma agrees with Almirall’s opinion Almirall shall be relieved of its obligation to use Commercially Reasonable Efforts to Commercialise Product in the country in question; 5.1.3 If GW Pharma disagrees with this opinion, the Parties shall timely perform a joint evaluation of the marketing opportunity in the country in question to resolve the economic case for Launching Product in such country. If having conducted such evaluation: (i) The Parties agree that there is an economic case for launching in a country but that Almirall does not wish to do so itself or on its own behalf, the Parties shall either: (a) agree a plan to jointly Commercialise Product for that indication in the country in question, in which case the Parties shall negotiate a change to the terms of this Agreement with regard to Commercialisation of Product in the country in question to reflect GW Pharma’s increased role; or if no agreement under this Clause 5.1.3(i)(a); (b) GW Pharma, in its absolute discretion, may elect to take over Commercialisation of Product in said country, in which case the right granted to Almirall under Clause 2.1 shall be deemed not to include the country in question and GW Pharma shall have the right to Commercialise Product for that Indication in

Commercialisation. 5.1 Subject 8.1 All decisions relating to Clause 5.16Commercialisation of each Product shall be in the sole discretion of Lundbeck, Almirallits Affiliates or its Sub-licensees with such Commercialisation to be carried out by Lundbeck, its Affiliates and/or its Sub-licensees at their cost and expense but always by making Commercially Reasonable Efforts to Commercialise each Product. 8.2 No later than twelve (12) months prior to the anticipated Launch of each Product for a particular indication, Lundbeck shall provide BioTie with a preliminary version of its Commercialisation Plan, including a Marketing Plan and a Budget for the Product. Such Commercialisation Plan, Marketing Plan and Budget shall be updated once each Year thereafter and shall be supplied to BioTie. Where such Commercialisation Plan is updated after Launch of each Product, in addition to containing details of Lundbeck’s core obligation proposed plans for Commercialisation, they shall also contain a summary of the progress of sales and marketing of Product for such indication in relation each Major Market and sales forecasts for the Year covered by the Commercialisation Plan. Such plan shall be received by BioTie subject to the obligations of Section 12 (Confidentiality). 8.3 Lundbeck shall keep BioTie informed of the Commercialisation of each Product in the Territory (including but not limited to sales for such indication) by way of a written report detailing the level of sales made during the previous Quarter (as reasonably available to Lundbeck at the time of compiling such report) and summarising any material developments relating to Commercialisation of Product for such indication in the Territory during the previous Quarter. Such report shall be submitted within sixty (60) days of the end of each Quarter. 8.4 Lundbeck hereby agrees at its own cost and expense that it shall: 8.4.1 comply with and maintain the Marketing Authorisations received for each Product, including by filing variations to such Marketing Authorisations as necessary; and 8.4.2 comply at all times with all Legal Requirements pertaining to the Commercialisation of each Product in each country in the Territory in which that Product is sold and shall be responsible for obtaining all necessary permissions, consents and licences (in addition to the Marketing Authorisation), required to Commercialise each Product under any Legal Requirement, including without limitation, any import approvals and wholesale dealer’s licenses. 8.5 Following Launch of the Product, Lundbeck shall use its Commercially Reasonable Efforts to achieve Launch Commercialise the same in each Major Market and in the countries (considered as a whole) comprising the rest of the Product for Territory so as to maximize the first Indication within overall sales of the Product. If BioTie at any time believes that Lundbeck is not using such Commercially Reasonable Efforts BioTie shall have the right, no more frequently than once every six (6) months after the grant of Marketing Authorisation (including pricing and/or reimbursement approval where such approval is necessary or industry practice for Launch) for Product for that Indication in each Major European Market and months, to give written notice to Lundbeck requesting written justification, in the form of detailed reasons with supporting calculations, which would support the proposition that Lundbeck is using Commercially Reasonable Efforts. Similarly, Lundbeck shall — upon BioTie’s request—provide BioTie similar justification should it not be proceeding with Commercialising the Product in some country having population of five (5) million people or more in Europe or twenty (20) million in other countries in belonging to the Territory, except for other parts of Africa than the republic of South-Africa. Thereafter Almirall Lundbeck shall use its Commercially Reasonable Efforts in each Major European Market and in provide such written justification to BioTie within sixty (60) days of the other countries in date of BioTie’s request. Should Lundbeck fail to provide reasonable written justification, and/or fail to cure any such deficiency within the Territory to realise the market potential of Product for that Indication and any subsequent Indication for which GW Pharma obtains a Marketing Authorisation save as provided below: 5.1.1 As soon as Almirall considers that there is no economic case for launching Product in a specific country in the Territory and in any event within first six (6) months of Marketing Authorisation the following period, BioTie may convert the license granted to Lundbeck under this Agreement into a non-exclusive license with effect for that the country being granted, Almirall shall give GW Pharma written notice of this opinion and include evidence in Document form or countries to support this opinion; 5.1.2 If GW Pharma agrees with Almirallwhich Lundbeck’s opinion Almirall shall be relieved of its obligation failure to use Commercially Reasonable Efforts applies by providing thirty (30) days’ prior written notice. For the purpose of determining whether Lundbeck is making Commercially Reasonable Efforts to Commercialise Product in the country in question; 5.1.3 If GW Pharma disagrees with European Union under this opinionSection 8, the Parties European Union shall timely perform be considered to be one country. BioTie’s right under this Section to convert the license granted to Lundbeck under this Agreement into a joint evaluation non-exclusive license shall in no event apply to the European Union or countries thereof. For the avoidance of the marketing opportunity doubt, subject to Section 14.2, this Section 8.5 is not intended to limit BioTie’s remedies under Swedish law, including claims for financial compensation, in the country in question event of failure by Lundbeck to resolve the economic case for Launching Product in such country. If having conducted such evaluation: (i) The Parties agree that there is an economic case for launching in a country but that Almirall does not wish to do so itself or on comply with its own behalf, the Parties shall either: (a) agree a plan to jointly Commercialise Product for that indication in the country in question, in which case the Parties shall negotiate a change to the terms of this Agreement with regard to Commercialisation of Product in the country in question to reflect GW Pharma’s increased role; or if no agreement obligations under this Clause 5.1.3(i)(a); (b) GW Pharma, in its absolute discretion, may elect to take over Commercialisation of Product in said country, in which case the right granted to Almirall under Clause 2.1 shall be deemed not to include the country in question and GW Pharma shall have the right to Commercialise Product for that Indication inAgreement.