Common use of Development of the Products Clause in Contracts

Development of the Products. 11.1 The Buyer shall, within one (1) month of Completion, provide to the Sellers the initial Development Plan and shall thereafter notify the Sellers of any material updates to the Development Plan in the six-monthly report referred to in Clause 11.5. 11.2 The Company shall, and the Buyer and all members of the Buyer’s Group shall, procure that the Company shall: 11.2.1 use Commercially Reasonable Efforts to implement the Development Plan; 11.2.2 use Commercially Reasonable Efforts to develop, have developed, make, have made, sell, have sold, commercialise or have commercialised the Products; 11.2.3 use Commercially Reasonable Efforts to achieve the Milestone Events; and 11.2.4 comply with its obligations pursuant to this Agreement, in each case until the Milestone Drop Dead Date. It is hereby agreed and acknowledged that in the event the Company, the Buyer or a member of the Buyer’s Group has not undertaken any substantive development or commercialisation activities relating to the Products for a period of twelve (12) months, it shall be considered to have failed to use Commercially Reasonable Efforts to develop and/or commercialise the Products. 11.3 Neither the Company nor any other member of the Buyer’s Group shall be in breach of the obligations contained in Clause 11.2 by virtue of any matter which is outside the control of such party, including (without limitation) through any change in the regulatory regime relevant to the Product or any delay in the regulatory approval process for the Product in any relevant jurisdiction arising from a matter outside its control. 11.4 Each of the Sellers and Buyer shall appoint a specific individual who shall be available and shall act as a “Liaison Person” to facilitate communications among the parties relating to developmental activities as set out in, or contemplated by, the Development Plan. Any changes to a Liaison Person shall be notified to the other parties in writing. In the case of the Individual Sellers, the Liaison Person shall be the Sellers’ Representative and in the case of the Company Sellers, the Liaison Person shall by Aquarius Life Sciences Limited. 11.5 The Sellers’ Representative may request, and upon such request be provided with, no later than sixty (60) days from the date of request, a detailed summary of material development and commercialisation activities undertaken in respect of any Product. The reports provided for in this Clause 11.5 shall contain such detail as is reasonably required by the Sellers in order to determine whether the Company or the Buyer or any member of the Buyer’s Group are complying with their obligations under Clause 11.2 together with summaries of: (i) all clinical trials protocols; (ii) final study reports from any clinical trials and (iii) material correspondence with the Regulatory Authority. The Sellers’ Representative may not make more than two (2) requests for the reports provided for in this Clause 11.5 in any calendar year. 11.6 The parties shall communicate (to the extent not otherwise announced by the Buyer publicly pursuant to Clause 16) promptly to each other any material events in the research, development and commercialisation of Products and in particular any serious adverse events occurring during a Clinical Trial.