Provision Language
Definitions
“HSR Clearance Date” shall mean the earlier of (a) the date on which the FTC or DOJ shall notify PTC and Roche of early termination of the applicable waiting period under the HSR Act, or (b) the day after the date on which the applicable waiting period under the HSR Act expires; provided, however, if the FTC or DOJ shall commence any investigation by means of a second request or otherwise, HSR Clearance Date shall mean the date on which any investigation opened by the FTC or DOJ shall have been terminated, without action to prevent the Parties from implementing the transactions contemplated by this Agreement with respect to the US.
7. Governance
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7.15 Change of Control. If there is a Change of Control of PTC, PTC shall provide prompt written notice thereof to Roche; provided that PTC may (but shall not be obligated to) notify Roche on a confidential basis of a contemplated Change of Control prior to the effective date of such Change of Control (the “Change of Control Notice”). Within [**] days after receipt of a Change of Control Notice (the “Election Period”), Roche shall provide PTC with written notice of its election to proceed with one of the following mutually exclusive options: (i) to continue the Research Program pursuant to this Agreement and the Research Plan, (ii) to exclude PTC from participation in the JSC and any JOT and thereafter internalize at Roche all activities allocated to PTC under the Research Plan, or (iii) to terminate this Agreement in accordance with Section 20.3.2; provided that regardless of the option elected, such election shall become effective only upon or after the effective date of such Change of Control of PTC. If Roche fails to provide a written election under the preceding sentence within the Election Period, then Roche shall be deemed to have elected to proceed under Section 7.15(i). If Roche makes a written election pursuant to Section 7.15(ii) within the Election Period, then the Quarterly R&D Fees with respect to Research Program activities conducted by PTC after the effective date of the Change of Control shall be adjusted accordingly to reflect the change in activities. The Parties acknowledge and agree that if Roche makes a written election within the Election Period pursuant to Section 7.15(ii) or Section 7.15(iii), PTC shall have no obligation to transfer the AS Assay to Roche, and Roche will not obtain any right or license with respect to the AS Assay or any intellectual property right therein.
20. Term and Termination
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20.3 Termination
20.3.1 Termination for Breach. A Party (“Non-Breaching Party”) shall have the right to terminate this Agreement in its entirety or on a country-by-country basis in the event the other Party (“Breaching Party”) is in breach of any of its material obligations under this Agreement. The non-BreachingParty shall provide written notice to the Breaching Party, which notice shall identify the breach and the countries in which the Non-Breaching Party intends to have this Agreement terminate. The Breaching Party shall have a period of [**] days (or [**] days in the case of a payment breach or a breach by Roche that, if not cured by Roche, is likely to trigger an SRA Special Termination, SRA Reversion Notice, SRA Buy-Out Notice or Foundation’s right to terminate the SRA) after such written notice is provided to cure such breach (“Peremptory Notice Period”). If such breach is not cured within the Peremptory Notice Period, this Agreement shall effectively terminate in such countries.
A Party shall have the right to terminate this Agreement if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof.
20.3.2 Termination by Roche for Change of Control of PTC. In the event of a Change of Control of PTC, Roche shall have the right, subject to Section 7.15, by written notice to PTC and Foundation given within the Election Period, to terminate this Agreement immediately, without prejudice to any of its other rights conferred on it by this Agreement or under applicable Law.
20.3.3 Termination by Roche Without a Cause. Roche shall have the right to terminate this Agreement at any time after the second anniversary of the Effective Date on aProduct-by-Product and country-by-country basis (i) upon three (3) months’ prior written notice before First Commercial Sale of the Product or (ii) upon nine (9) months’ prior written notice after the First Commercial Sale of the Product. The effective date of termination under this Section 20.3.3 shall be the date three (3) months or nine (9) months, as the case may be, after Roche provides such written notice to PTC.
20.3.4 Termination by PTC for Patent Challenge. If any member of the Roche Group (or Chugai with the acquiescence of Roche) challenges the validity, enforceability, patentability or scope of any claim included in any PTC Patent Right or Joint Patent Right, or supports, directly or indirectly, any such challenge (any of the foregoing, a “Patent Challenge”), PTC shall have the right to terminate this Agreement with respect to such challenged PCT Patent Right or Joint Patent Right upon thirty (30) days’ written notice to Roche with respect to the PTC Patent Right or Joint Patent Right that is subject of the Patent Challenge. In addition, if such Patent Challenge is terminated during such thirty (30) day period, then PTC shall not have the right to terminate this Agreement in respect of such Patent Challenge; provided, however, that Roche shall reimburse PTC for all costs and expenses, including without limitation attorneys’ fees, incurred by PTC in defending such Patent Challenge, and shall pay all such reimbursement amounts within [**] days after receipt of an invoice from PTC therefore.
20.3.5 Termination by PTC for Post-Change of Control Material Change. PTC shall have the right to terminate this Agreement as set forth in Section 22.2.
20.3.6 Termination for Delay in Effective Date. Either Party may terminate this Agreement effective upon notice to the other Party if the HSR Clearance Date shall not have occurred on or prior to the date ninety (90) days after the Parties make their respective HSR Act filings pursuant to Section 22.1. If thisAgreement is terminated pursuant to this Section 20.3.6, this Agreement, including without limitation Section 20.5, shall terminate in its entirety and shall be void and of no force or effect.
22. Miscellaneous
22.1 HSR Act. If in the reasonable opinion of counsel to Roche or PTC it is required that the Parties make a filing under the HSR Act, Roche and PTC will promptly following the Execution Date (i) take all actions necessary to make any filing required under the HSR Act and (ii) reply at the earliest possible date with any requests for information received from the United States Federal Trade Commission (“FTC”) or Antitrust Division of the United States Department of Justice (“DOJ”) pursuant to the HSR Act. The Parties will, to the extent reasonably practicable, consult with one another prior to making any filings, responses to inquiries or other contacts with the FTC or DOJ concerning the transactions contemplated by this Agreement and will use Commercially Reasonable Efforts to obtain any clearances related to this Agreement that are necessary under the HSR Act. Each Party will be responsible for its own costs in connection with such filing, except that Roche will be solely responsible for the applicable filing fees. Roche shall provide PTC notice of achievement of the HSR Clearance Date on the HSR Clearance Date.
22.2 Change of Control of Roche. Following a Change of Control of Roche, it is the expectation of the Parties that the research, development and commercialization of Products will continue in substantially the same manner as immediately prior to the occurrence of such Change of Control, including without limitation as reflected in the then applicable Research Plan, SRA Development Plan and New Product Development Plan. Within [**] days following the closing of a Change of Control, Roche shall provide PTC and the Foundation written certification from Roche and Roche’s acquirer that Roche will continue to perform all of its obligations under this Agreement. In furtherance of the foregoing, with respect to each Product the following provisions shall apply:
(a) The Research Plan, SRA Development Plan and the New Product Development Plan in effect as of the occurrence of each Change of Control for such Product shall remain in effect for the remaining period covered by such plans, unless otherwise agreed by the Parties.
(b) If PTC believes that a Post-Change of Control Material Change (as defined below) has occurred with respect to such Product, PTC shall provide written notice of such belief to Roche and the Foundation. Within [**] days after receipt of such notice, Roche shall respond in writing to PTC, and the Parties shall meet within [**] Business Days thereafter to discuss the issues raised in the notice from PTC and the response from Roche. The Parties shall attempt in good faith to reach consensus on whether a Post-Change of Control Material Change has occurred with respect to such Product in accordance with Section 22.6.
In the event that either (i) the Parties agree that a Post-Change of Control Material Change has occurred with respect to such Product, or (ii) a final judicial determination is made in accordance with Section 22.6 that a Post-Change of Control Material Change has occurred with respect to such Product, then PTC shall have the right to terminate this Agreement effective upon written notice to Roche within [**] days after the date of such agreement or determination. As used in this Section 22.2, the term “Post-Change of Control Material Change” means, with respect to a Product, (A) there has been a material adverse impact on the market for such Product as a result of specific actions or omissions by Roche or its successor that do not comply, or are inconsistent, with the then applicable Research Plan, SRA Development Plan, or New Product Development Plan, or (B) specific actions or omissions by Roche or its successor have triggered the availability of a right on the part of Foundation to cause an SRA Special Termination, to obtain an SRA Reversionary License and/or to exercise the SRA Buy-Out Right, in each case pursuant to the procedures set forth in the SRA.