“Major Market” means any of the United States, the United Kingdom, Japan, and any two of the following: France, Spain, Germany and Italy.
“Not for Profit Basis” means (a) sales of Products where the consideration received by the seller is less than or equal to the sum of the Cost of Goods for such Product; in calculating the consideration received by the seller account shall be taken of any equity or lump sum or other payments received by the seller in respect of the Product; or (b) or sales of Products where the seller is a charitable organisation (other than the Trust or its Affiliates) under applicable law;
11.7 If PTC (either by itself, through any other member of the PTC Group, or through a Distributor) decides, at its own discretion not to Develop and Exploit any discrete part of the Programme Intellectual Property, PTC shall take reasonable steps to identify potential Licensees of the Programme Intellectual Property to Develop and Exploit Products. If neither PTC nor any other member of the PTC Group (either by itself or through a Distributor or Licencee) takes reasonable steps to Develop and Exploit the Programme Intellectual Property, that Trust shall have the rights set out in Clause 12.
12. TRUST STEP–IN RIGHTS
12.1 Subject to Clause 12.4:
(a) if no member of the PTC Group or sub–licensees of the PTC Group is taking reasonable steps to Develop or Exploit any Programme Intellectual Property or Products for a particular indication for a consecutive period of [**] months or more following completion of the Programme, and, upon receipt of a written notice from the Trust served at the end of, or after such [**] month period requesting that the Programme Intellectual Property is Developed and/or Exploited, does not for an additional [**] months take any reasonable steps in this regard; or
(b) at any time after the first sale of a Product in a Major Market in a particular indication, no PTC Group member or any sub–licensees of any PTC Group member have taken reasonable steps to Develop and/or Exploit that Product in that particular indication in another Major Market for a consecutive period of [**] months, and, upon receipt of written notice from the Trust after such [**] month period requesting that the relevant Product is Exploited in such other region(s) and in such indication, does not for an additional [**] months take reasonable steps in this regard; then, following the expiry of the time periods set out above, the Trust shall have the option in its sole discretion by giving written notice to PTC Therapeutics to become the Exploiting Party and to take responsibility for the Development and Exploitation of such Programme Intellectual Property and Products in the relevant indication(s) and region(s), which includes discretion to make any and all decisions (in consultation with the RSG) regarding the negotiation, acceptance and conclusion of terms for any agreement regarding the Development and Exploitation of such unexploited Programme Intellectual Property (including Development and Exploitation by way of licence, sale, materials transfer or other transfer of rights, as well as any transaction which involves placing such unexploited Programme Intellectual Property into a separate corporate vehicle) in such region.
12.2 If the Trust exercises its right to exploit any Programme Intellectual Property under Clause 12.1:
(a) PTC will exclusively licence to the Trust or its nominee, the Programme Intellectual Property in such indications or regions as are specified in the notice served by the Trust exercising the option consistent with the applicable sub–clause in Clause 12.1. The terms of such exclusive licence to the relevant Programme Intellectual Property shall:
(i) be free of consideration in respect of sales of Product made on a Not–for–Profit Basis, and
(ii) include a share of any revenue or other consideration received by the Trust under any license of relevant Product Intellectual Property with respect to all other sales, such share to be based on the respective contributions made by PTC and the Trust in the Development and Exploitation of such Product;
(b) PTC will grant to the Trust or its nominee, a non–exclusive licence to relevant Background Intellectual Property solely as required and for the purposes of enabling the Trust to exercise the rights to the relevant Programme Intellectual Property as described in (a) above and solely in the regions specified in the notice served by the Trust exercising the option. Any such licence grant shall be non–exclusive and free of charge other than for reasonable costs that are incurred in respect of necessary third–party licences; and
(c) provide the Trust with access to any associated data, Documents (including, without limitation, Documents relating to pre–clinical data and clinical trials), pre–clinical data, Materials (only to the extent actually in existence and amenable to transfer in reasonable quantities without further regulatory approval(s), and not to include commercial inventory of Product for which PTC retains rights to Exploit), regulatory approvals, Marketing Approvals, or information as required for the Trust to exploit such rights.
12.3 If the Trust exercises its right to exploit any Programme Intellectual Property under Clause 12.1 above, PTC agrees that it shall pass (or will procure that relevant members of the PTC Group shall pass) to the Trust immediately any or all exploitation opportunities in the applicable region(s) that it becomes aware of from time to time in connection with the Programme Intellectual Property. PTC further undertakes that it shall not (and that it shall procure that no member of the PTC Group shall) engage in any activities (including in relation to the Background Intellectual Property) that could reasonably lead to the loss of an exploitation opportunity in the applicable region and with respect to the applicable indication(s) without the prior written consent of the Trust.
12.4 Notwithstanding anything to the contrary set forth in this Clause 12, in the event that PTC or a member of the PTC Group licenses a Third Party to exploit the Programme Intellectual Property (whether alone or together with other Intellectual Property of any member of the PTC Group) in any indications and in any regions then the Trust shall have no rights under this Clause 12 with respect to such Programme Intellectual Property in such indications and in such regions, where:
(a) under a written agreement with a member of the PTC Group, such licensee is required to use diligent efforts to exploit the licensed Programme Intellectual Property in the relevant indication in the relevant region(s), and such written agreement provides for a reversion to the relevant member of the PTC Group of the Programme Intellectual Property in such indication and in such region(s) if the licensee materially breaches this diligence obligation; or
(b) the Trust has approved such licence in writing.