Optimi definition

Optimi is Optimi Health Corp, a company incorporated in British Columbia under number BC 1251418, (which expression shall include its successors and assigns) of 60▇ - ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇.▇., ▇▇▇ ▇▇▇.
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Optimi or the “Company”), a Canadian manufacturer of GMP-certified, naturally-derived psilocybin and MDMA, has entered into binding agreements with Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed"). Under the terms of the agreement, Psyence Biomed will exclusively source GMP-certified psilocybin from Optimi for its clinical research and drug development programs, including its Phase IIb trial for Adjustment Disorder and commercialization initiatives for FDA-approved uses in Palliative Care. As part of the agreements, Optimi will supply GMP-certified, nature-derived psilocybin extract capsules and provide comprehensive Chemistry, Manufacturing, and Control (“CMC”) support to facilitate regulatory submissions. This collaboration guarantees Psyence Biomed's access to a consistent GMP supply of natural psilocybin for its current and future clinical programs, including preparations for Phase III registrational trials and potential commercialization. Psyence Biomed is also advancing its Investigational New Drug (IND) application process with the U.S. Food and Drug Administration (FDA), leveraging Optimi’s psilocybin to meet strict regulatory requirements. “This partnership highlights Optimi’s leadership in the production of high-quality psilocybin drug candidates for clinical trials,” said ▇▇▇▇ ▇▇▇▇▇▇▇, Chief Executive Officer of Optimi. “As Psyence Biomed’s exclusive supplier, we are proud to support their important work addressing significant unmet mental health needs in Palliative Care. We are excited to see our natural psilocybin extract further validated in a clinical setting and take another step toward commercial use with Psyence Biomed.” ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇, Chief Executive Officer of Psyence Biomed, added: “Optimi’s psilocybin extract capsules align with the strict quality and regulatory standards we require for our clinical programs and drug development. This partnership ensures we have the resources necessary to advance our Phase IIb trial, pursue our IND registration, and prepare for the next stages of global research initiatives and commercialization efforts.”
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Examples of Optimi in a sentence

  • Psyence may request changes to the product specifications for any product to be delivered under this Agreement by submitting a written change request ("Change Request") to Optimi.

  • All payments shall be made by wire–transfer to a bank account, specified by the Optimi in writing, without any set–off, deduction, or withholding.

  • Documents will be considered to have been delivered to the Issuer on the next business day following the date of transmission, if delivered by fax or email, the date of delivery, if delivered by hand during normal business hours or by prepaid courier, or 5 business days after the date of mailing, if delivered by mail, to the following: Optimi Health Corp.

  • If latent defects or any defects not reasonably identifiable at the time of collection are discovered within the specified period after arrival at Psyence’s premises, Psyence shall notify Optimi in writing within 5 business days of discovering the defect(s).

  • Optimi hereby assigns to Psyence, and shall cause its employees, agents and contractors to assign to Psyence and to do all things necessary to give effect to this intention.

  • If the books are returned undamaged, unused and unopened to the Optimi Warehouse (books cannot be delivered to an Optimi Office) within 1 calendar month of the cancellation.

  • Title, and risk of loss or damage, to any purchased Goods will pass from the Optimi to Psyence on delivery and Psyence will thereafter be responsible for all risks of loss of or damage to such Product.

  • Optimi shall investigate all OOS stability results or adverse trends in accordance with this Agreement.

  • In the event that this agreement or the Bundle of Agreements is terminated Optimi will do all things necessary to enable Psyence to continue to generate stability data (either itself or through a third party supplier) to support the acceptability of the Goods until all Goods distributed by Psyence have reached the end of their shelf life, with the Parties undertaking to act in the utmost good faith in enabling the execution of this obligation.

  • During normal working hours and upon reasonable notice, Optimi or its designee shall be entitled to inspect areas within Psyence's facility where the Product is manufactured or stored, and to inspect the manufacturing, packaging, and quality control records relating to the Product if i) a critical observation was identified on any audit report, or (ii) where required to do so by a health regulatory authority having jurisdiction of the Clinical Trials.

Related to Optimi

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