Contract analysis

1. Acknowledgment of Veridian's Position on Academic Freedom At the outset, Penterra recognizes and respects Veridian's institutional mission and stature. Veridian is a 501(c)(3) tax-exempt research organization operating thirty-eight (38) academic medical centers and affiliated research institutions across fourteen (14) states. As a leading research network, Veridian has a well-established and deeply held commitment

2. Penterra's Legitimate Interests Requiring a Review Period Penterra's request for a pre-publication review period is grounded in four distinct but interrelated interests, each of which is standard in the sponsor–investigator relationship and well recognized in both industry practice and academic institutional policy. Protection of Confidential Information. The MCTA, as currently drafted and as reflected in both par

3. Analysis of Veridian's Proposed Language We turn now to the specific language proposed by Veridian in its April 28, 2023 markup of Exhibit G. As reflected in that markup, Veridian proposes that investigators would have an unrestricted right to publish study results arising from the CLARION trial, subject only to a thirty (30)-day "courtesy" notice to the sponsor. The notice is characterized as a courtesy — not as

4. Penterra's Compromise Proposal: 60-Day Review Period Plus 90-Day Patent Delay Having identified the shortcomings of Veridian's proposed language, Penterra offers the following compromise framework, which we believe fairly balances the interests of both parties and is consistent with prevailing industry standards for multi-center Phase III clinical trial agreements. 4.1 — 60-Day Sponsor Review Period Penterra propo

5. Industry Standard and Precedent Penterra's proposed framework — a sixty (60)-day review period with an additional ninety (90)-day delay for patent protection — is consistent with prevailing industry standards for Phase III multi-center clinical trial agreements in the United States. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) on Goo

6. Proposed Draft Language In light of the foregoing analysis, Penterra proposes the following revised language for incorporation into Exhibit G to the MCTA (Intellectual Property and Publication Rights). We have attached a complete copy of the proposed language as an enclosure to this letter; however, for ease of reference during your review, we set forth the key provisions below: Section __.01 — Definitions. For pu

7. Relationship to Other MCTA Provisions The publication rights framework proposed above must be read in conjunction with several other provisions of the MCTA. For completeness, and to assist your review, we summarize the key interrelationships as follows: Exhibit F — Confidentiality and Data Protection Provisions. Exhibit F establishes a ten (10)-year confidentiality term covering all Protocol-related information ex

8. Request for Response and Next Steps We respectfully request that Veridian and your firm review the foregoing proposal and provide a written response by no later than May 30, 2023. Our objective is to reach agreement on the publication rights language in sufficient time for it to be incorporated into the Second Draft MCTA, which is currently being finalized for circulation. To the extent that Veridian has specific