Master Alliance Provisions Guide (MAPGuide)

Wellcome Trust – PTC Therapeutics, Cancer Treatment Research Funding Agreement

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Definitions

“Programme Term” means the time period commencing on the Commencement Date and ending on the earlier of completion of the Programme or three (3) years

2. AWARD

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2.3 When PTC considers that any Milestone has been achieved by the relevant Milestone Date:

(a) PTC shall as soon as reasonably practicable provide the Trust with a detailed report (the “Milestone Report”) setting out how the Milestone was achieved and requesting payment of the next Tranche of the Award Amount.

(b) The Trust shall confirm to PTC in writing, within [**] Business Days of receipt by the Trust of the Milestone Report either that:

(i) the Milestone has been achieved by the Milestone Date to the Trust’s reasonable satisfaction, in which case the Trust shall make payment of the next Tranche of the Award Amount within [**] Business Days of the date of such written confirmation in the amount determined by the Trust from time to time; or

(ii) the Milestone has not been achieved to the Trust’s reasonable satisfaction by the relevant Milestone Date and that the payment shall not take place, in which case the Trust shall provide PTC with reasonable details of the grounds on which it has reached this decision.

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2.5 PTC shall complete and submit a detailed report on the work done and outcomes of the Programme (“End of Award Report”) in the prescribed form to the Trust, such report to be presented to the Trust within [**] days after the completion of the Programme (or such other date as may be agreed with the Trust). The Trust will evaluate the End of Award Report and will notify PTC within [**] Business Days of receipt whether the report is acceptable to the Trust. If the End of Award Report is not acceptable to the Trust, it shall notify PTC of its reasons at the same time, which may include that the report is incomplete or insufficiently detailed and the Trust shall have the right to withhold further funding until the Trust receives an End of Award Report which the Trust deems to be acceptable.

3. THE PROGRAMME

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3.3 Subject to existing confidentiality obligations and legal restrictions, including contractual restrictions, PTC shall inform the RSG in writing of any on–going research being carried on by PTC or any on–going research that, to the knowledge of PTC, is being carried on by any other member of the PTC Group in the Field. PTC undertakes, throughout the duration of this Agreement, to use its reasonable endeavours to co–operate with and to adopt a synergistic and collaborative approach to work with Third Parties working on similar research and development programmes to the Programme.

4. PROGRAMME MANAGEMENT AND PROGRAMME AUDIT

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4.4 PTC shall maintain, or cause to be maintained, books and records of its activities under the Programme and its expenditure of the Trust Award (the “Programme Books and Records”) in sufficient detail and in good scientific manner appropriate for audit, patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective activities under the Programme, and which shall be retained by PTC for at least [**] years after the creation of the record, or for such longer time period prescribed by PTC’s document retention policies or as may be required by applicable law. The Trust shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any Programme Books and Records if required for audit, patent or regulatory purposes provided that the Trust shall not be entitled to exercise this right more than [**] in any calendar year, shall only use such information for the purposes of exercising its rights or complying with its obligations under this Agreement, and shall treat such Programme Books and Records and any copies thereof as Confidential Information.

4.5 PTC shall procure that the control of expenditure to be funded under the Award is governed by the normal accounting standards and procedures applicable to members of the PTC Group and such expenditure shall be covered by the formal audit arrangements that exist within the PTC Group. Following the annual audit of PTC by its external auditors, PTC shall provide the Trust with the audited financials which shall indicate whether the external auditors have signed their opinion on the annual accounts of PTC without qualification. PTC shall further confirm in writing to the Trust that the management letter from the auditors raises no matters that did or could significantly affect the administration of grants awarded by the Trust. If the auditors have raised any such matters in their management letter, PTC shall, on request from the Trust, provide the Trust with relevant extracts from the letter.

4.6 During the Programme Term and for a period of [**] years afterwards, the Trust shall have the right, at its discretion and expense, to audit (either directly or via a Third Party engaged by it):

(a) any expenditure of the Award Amount including, without limitation, any expenditure by PTC, any other member of the PTC Group, Co–applicants, collaborators and/or subcontractors;

(b) the systems used by PTC to administer Trust grants generally; and

(c) any equipment acquired under the Award Amount.  Provided, that the Trust shall not be entitled to exercise this audit right more than [**] in any calendar year, and shall only use such information for the purposes of exercising its rights or complying with its obligations under this Agreement, and shall treat the any documents reviewed or information received as a result of such audit as Confidential Information.

4.7 In furtherance of the Trust’s audit right pursuant to Clause 4.6, PTC shall (and shall procure that its Affiliates shall) provide access at any time during business hours for auditors and other personnel from or appointed by the Trust to accounting and other financial and corporate records relating to this Agreement, the Award, the Programme Books and Records, and the activities funded by the Trust (at the Trust’s expense), if requested at any time on reasonable advance notice. Where any of the Award Amount has been paid by PTC to any collaborators and/or sub–contractors, PTC shall use its best efforts to procure that the right of access for audit purposes extends to the accounts and records of any such collaborator and subcontractor.

5. THE RESEARCH STEERING GROUP

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5.7 During the Programme Term, PTC shall procure that the Principal Investigator monitors the work carried out under the Programme for material that may be the subject of Programme Inventions and shall promptly notify the RSG of any such Programme Invention. Without prejudice thereto, during the Programme Term, PTC shall make reports on work being carried out under the Programme to the RSG [**], or from time to time as the RSG may reasonably request, such reports to include the progress of the Programme as well the matters described in Clause 11.9.

6. SITE VISIT GROUP

6.1 The Trust may appoint a Site Visit Group, made up of a small team of independent experts and observers from the Trust’s Technology Transfer Division. The Site Visit Group shall have reasonable access for the duration of the Programme during normal working hours and at mutually agreed times to visit all the premises where the Programme is being conducted to consult informally with PTC’s employees, researchers, consultants or contractors working on the Programme to evaluate progress, performance and key issues and to report back to the Trust and the RSG on their findings.

6.2 The Site Visit Group may recommend that the Trust terminates the Programme due to a serious failure in the progress, management or conduct of the Programme (including but not limited to a finding that the Programme will be unable to achieve the next Milestone within a reasonable time period after the relevant Milestone Date), or due to a major external scientific, technical or commercial barrier which means that the Programme is unlikely to succeed in its objectives. If the Site Visit Group makes such a recommendation pursuant to this Clause 6.2, it must provide written notice of its recommendation and the rationale therefor to the Parties.

6.3 If PTC is unable to remedy a serious failure or external barrier identified by the Site Visit Group pursuant to Clause 6.2 within [**] Business Days, or such longer time period as the Trust may, in its sole discretion, allow, the Trust may terminate this agreement pursuant to Clause 20.3(b).

7. PROGRAMME COLLABORATORS AND SUBCONTRACTORS

7.1 If PTC wishes to use a Third Party collaborator or sub–contractor to conduct any part of the Programme, it shall seek the consent of the RSG unless such sub–contractor or collaborator is specified in the Application. PTC shall provide a copy of the agreed form of any sub–contract or collaboration agreement to the Trust for review by the Trust prior to signature by the parties thereto. Unless otherwise agreed in writing between the Parties, PTC shall ensure in all cases that any collaborations or sub–contracts shall be on the following terms: […]

(d) that the Third Party will upon reasonable request make available its premises where the Programme is being conducted, and its employees and/or consultants for discussion with the Site Visit Group as referred to in Clause 6, except where prohibited by applicable law;

11. EXPLOITATION

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11.3 Prior to any member of the PTC Group (whether itself or through any other member of the PTC Group, or by granting a license or in collaboration with any Third Party) (the “Exploiting Party”), commencing the Development and/or Exploitation of any Programme Intellectual Property and/or Products both inside and outside the Field, PTC or the relevant the member of the PTC Group shall obtain the prior written consent of the Trust to such Development and Exploitation by sending written notice to the Trust and the following information:

(a) reasonable details of the relevant Programme Intellectual Property, the Products and the activity proposed;

(b) details of whether the proposed Exploitation will be on a For–Profit and/or Not–For–Profit Basis; and

(c) if applicable, amounts of any milestones payments and royalties that would be payable to the Trust pursuant to Schedule 6 and any other applicable terms.

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11.6 The Trust shall notify PTC in writing within [**] days of the receipt of the notice from PTC as to whether it consents (such consent not to be unreasonably withheld) to the Development and Exploitation of the Programme Intellectual Property and/or Products inside or outside the Field. Following receipt of such consent, PTC shall be free to Develop and Exploit the relevant Programme Intellectual Property in accordance with the consent given by the Trust without further consent or approval from the Trust. If, in respect of any Programme Intellectual Property, the Trust does not give its consent, the Parties shall meet to discuss the Trust’s concerns and if they are unable to resolve those concerns the matter shall be referred to the dispute resolution procedure set out in Clause 19. All agreements entered into by PTC relating to the Programme Intellectual Property shall be consistent with the terms of this Agreement.

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11.9 During the Programme Term, PTC shall keep the Trust reasonably informed on all matters relating to the Development and Exploitation of the Programme Intellectual Property and Products by or on behalf of PTC via the [**] RSG reports required pursuant to Clause 5.7. Following the Programme Term, PTC shall provide all matters relating to the Development and Exploitation of the Programme Intellectual Property and Products by or on behalf of PTC [**].

13. REVENUE PAYMENTS

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13.3 Within [**] days of the end of each Quarter, the paying Party shall deliver a statement to other Party setting out all sales of Product made by the paying Party, any member of the paying Party’s Group or any Third Party in the relevant Quarter and the amount of revenue and any payment under Clauses 12 and 13 which is due to the receiving Party (“Quarterly Statement”). The receiving Party shall deliver to the paying Party an invoice for the amount due as set out in the Quarterly Statement in United States dollars. The revenue amount and any other amount invoiced shall be payable to the receiving Party within [**] days of receipt of the invoice.

14. AUDIT OF REVENUE DUE

14.1 The Exploiting Party shall keep legible, true and accurate records and books of account for [**] years following the end of the calendar year to which they relate and procure that any affiliate of the Exploiting Party which is Exploiting the Programme Intellectual Property and any licensees of the Programme Intellectual Property shall keep legible, true and accurate records and books of account for [**] years following the end of the calendar year to which they relate, which contain all data necessary for the calculation of the revenue payable by it to any other Party (the “Books”).

14.2 The Non–Exploiting Party shall have the right for a period of [**] years after receiving any report or statement with respect to royalties due and payable to appoint an internationally–recognized independent accounting firm (the “Auditor”) reasonably acceptable to the Exploiting Party to inspect the Books to verify such reports, statements, records or books of accounts, as applicable. Before beginning its audit, the auditor shall execute an undertaking acceptable to the Party being audited by which the auditor shall keep confidential all information reviewed during such audit. The auditor shall have the right to disclose to both the Party arranging the audit and the Party whose books have been audited, its conclusions regarding any payments owed to such Party.