Master Alliance Provisions Guide (MAPGuide)

Wellcome Trust – PTC Therapeutics, Cancer Treatment Research Funding Agreement

  • Intellectual Property | Protection of IP

Definitions

“Background Intellectual Property” means:

(a) any Intellectual Property other than the GEMS Intellectual Property created, devised, generated, owned by or licensed to the PTC Group or which the PTC Group has rights to prior to the Commencement Date (but excluding, for the avoidance of doubt, the Programme Intellectual Property), which are necessary or useful for undertaking the Programme, for the protection or exploitation of the Programme Intellectual Property, and/or which are necessary or useful for the development and exploitation of the Programme Intellectual Property; and

(b) The following patents or patent applications: [**];

“Background Know-How” Means any and all Know-How and any components thereof (including without limitation manufacturing processes and quality control procedures) other than the GEMS Know-How which are used by the PTC Group at any time for the Programme which are necessary or useful for undertaking the Programme, for the protection or exploitation of the Programme Intellectual Property, and/or which are necessary or useful for the development and exploitation of the Programme Intellectual Property, but excluding the Programme Intellectual Property. For the avoidance of doubt, PTC Background Know-How shall include Know-How generated by any PTC Affiliate and subsequently used by PTC for the Programme;

“GEMS” means PTC’s drug discovery technology for the modulation of gene expression by small molecules.

“GEMS Intellectual Property” means:

(a) any Intellectual Property created, devised, generated, owned by or licensed to the PTC Group or to which the PTC Group has rights (but excluding, for the avoidance of doubt, the Programme Intellectual Property), which relates to the GEMS technology; and

(b) The following patents or patent applications: [**]

“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;

8. INTELLECTUAL PROPERTY — OWNERSHIP AND PROTECTION

8.1 In the event that any Programme Intellectual Property arises, it shall be the property of PTC. Any Programme Patents arising from such Programme Intellectual Property shall be applied for in the name of PTC. PTC shall have the first option to take responsibility for seeking and maintaining protection for Programme Intellectual Property in consultation with the RSG at PTC’s sole cost, including the filing, conduct, prosecution and maintenance of all patents arising in respect of Programme Inventions.

8.2 If PTC chooses not to pursue filing, prosecution or maintenance of any Programme Patents in any country, it shall immediately notify the Trust of this fact in writing. The Trust shall be entitled, but not obliged, at its own cost, to pursue or maintain such Programme Patents in the relevant country or countries in PTC’s name and PTC shall provide such assistance to the Trust at the Trust’s sole cost as may reasonably be required by the Trust in order to do so.

8.3 Without prejudice to the terms of this Clause 8.3, PTC shall (and shall procure that the Principal Investigator shall) execute such further documents, take such action and do such things as may be reasonably requested by the Trust at the Trust’s cost to secure the right of the Trust to protect, maintain, manage, defend, enforce and exploit the Programme Intellectual Property referred to in this Clause 8 and Clauses 9, 10, 11 and 12 below.

8.4 PTC shall make the Background Intellectual Property available for use in the Programme and for the protection, development and exploitation of the Programme Intellectual Property. PTC shall, unless otherwise agreed, retain responsibility for seeking and maintaining protection for the Background Intellectual Property at its own cost. If PTC chooses not to pursue filing, prosecution, maintenance, defence or enforcement of any patent rights that are Background Intellectual Property in any country, they shall give the Trust at least [**] months’ notice of this fact in writing. During the [**]-month notice period, PTC shall continue to seek and maintain such patent rights. The Trust shall be entitled, but not obliged, at its own cost, to assume responsibility (on behalf of PTC) for filing, prosecuting, maintaining, defending or enforcing such patent rights in the relevant country or countries in PTC’s name and PTC shall provide such assistance to the Trust at the Trust’s cost as may reasonably be required by the Trust in order to do so.

9. INTELLECTUAL PROPERTY MANAGEMENT GROUP

9.1 PTC and the Trust shall establish an Intellectual Property Management Group (“IPMG”), which shall:

(a) approve all public disclosures relating to the Programme, including presentations, posters and papers (provided that the contribution of the Trust is acknowledged in all such publications and quoting the Award number);

(b) identify new inventions arising out of the Programme and make recommendations for IP strategy, including patent filing and prosecution strategy and assessment of freedom to operate issues;…[.]

10. INFRINGEMENT

10.1 Each Party shall immediately give notice to the other Party if any member of the Trust, the PTC Group or their Staff become aware of:

(a) any infringement of the Background Intellectual Property or Programme Intellectual Property; or

(b) any claim by a Third Party that an action carried out under the Programme infringes the Intellectual Property or other rights of any Third Party.

10.2 In respect of any Background Intellectual Property or Programme Intellectual Property, where any infringement or suspected infringement arises, or a claim by a Third Party alleging infringement of that Third Party’s Intellectual Property or other rights arises, then:

(a) As soon as possible after receiving the notice required by Clause 10.1, the Parties will convene a meeting of the IPMG at which the IPMG shall discuss in good faith all available evidence with respect to the matters underlying the notice, and the appropriate manner of addressing such matters, including preventing or stopping infringing activities (for example, by seeking a preliminary injunction), preserving the Parties’ rights to past and future damages (for example, by sending a cease and desist letter) defending against declaratory judgment actions with respect thereto, or taking any other actions, or no actions, as the Parties shall determine. The IPMG shall take into account each Party’s interest in formulating the response, if any, to infringement or threatened infringement of such Background Intellectual Property or Programme Intellectual Property, including the relative merits of patent litigation versus the nature, scope and potential economic consequences of the Infringement.

(b) Unless otherwise determined by the IPMG as part of its consideration of an overall patent strategy, or pursuant to its evaluation of a notice pursuant to Clause10.2(a), if a member of the PTC Group (or any licensee of a member of the PTC Group) is exploiting the relevant Programme Intellectual Property but PTC notifies the Trust that it does not intend to take such action, the Trust, at its discretion and cost may  take such action as it shall consider to be necessary or appropriate to bring or defend an action on behalf of the relevant member of the PTC Group or licensee thereof and PTC shall (and shall procure that relevant members of the PTC Group shall) provide all reasonable assistance to Trust as the Trust may request (at the Trust’s cost); and

(c) Unless otherwise determined by the IPMG as part of its consideration of an overall patent strategy, or pursuant to its evaluation of a notice pursuant to Clause10.2(a), if the Trust (or any licensee of the Trust) is exploiting the relevant Programme Intellectual Property following exercise of its rights pursuant to Clause 12,the Trust may take such action as it shall consider to be necessary or appropriate at its discretion and expense to bring or defend an action on behalf of the relevant member of the PTC Group. PTC shall (and PTC shall procure that the relevant member of the PTC Group shall) give the Trust all reasonable assistance as the Trust may request (at the Trust’s cost) in relation to such action, including granting the Trust the right to bring such action in PTC’s name.

10.3 In the event that any enforcement or defence action whether by a member of the PTC Group and/or the Trust results in the recovery of legal costs and/or an award of damages, such sums shall be distributed in accordance with the following the following order of priority: (a) first, to reimburse each Party for all litigation costs in connection with such proceeding paid by that Party and not otherwise recovered (on a pro rata basis based on each Party’s respective litigation costs, to the extent the recovery was less than all such litigation costs); and (b) second, [**] percent ([**]%) to the enforcing Party and [**] percent ([**]%) to the non–enforcing Party.

10.4 Notwithstanding the above, except as may be agreed otherwise by the Parties following good–faith discussions, no Party shall enforce their rights under any Programme Intellectual Property for infringement or potential infringement by:

(a) any organisation operating on a Not for Profit Basis or any charitable organisation which is conducting non–commercially sponsored research; and/or

(b) any person carrying out non–commercially sponsored research on behalf of any organisation operating on a Not for Profit basis or any charitable organisation.