Regulation AB Compliance; Intent of the Parties; Reasonableness The parties hereto acknowledge that interpretations of the requirements of Regulation AB may change over time, whether due to interpretive guidance provided by the Commission or its staff, consensus among participants in the asset-backed securities markets, advice of counsel, or otherwise, and agree to comply with all reasonable requests made by the Depositor in good faith for delivery of information under these provisions on the basis of evolving interpretations of Regulation AB. In connection with the Trust, each Servicer, the Trustee and each Custodian shall cooperate fully with the Depositor to deliver to the Depositor (including its assignees or designees), any and all statements, reports, certifications, records and any other information available to such party and reasonably necessary in the good faith determination of the Depositor to permit the Depositor to comply with the provisions of Regulation AB, together with such disclosures relating to each Servicer, the Trustee and each Custodian, as applicable, reasonably believed by the Depositor to be necessary in order to effect such compliance.
Presentation of Potential Target Businesses The Company shall cause each of the Initial Shareholders to agree that, in order to minimize potential conflicts of interest which may arise from multiple affiliations, the Initial Shareholders will present to the Company for its consideration, prior to presentation to any other person or company, any suitable opportunity to acquire an operating business, until the earlier of the consummation by the Company of a Business Combination or the liquidation of the Company, subject to any pre-existing fiduciary obligations the Initial Shareholders might have.
Know-How Necessary for the Business The Intellectual Property Rights are all those necessary for the operation of the Company’s businesses as it is currently conducted or as represented, in writing, to the Purchasers to be conducted. The Company is the owner of all right, title, and interest in and to each of the Intellectual Property Rights, free and clear of all liens, security interests, charges, encumbrances, equities, and other adverse claims, and has the right to use all of the Intellectual Property Rights. To the Company’s knowledge, no employee of the Company has entered into any contract that restricts or limits in any way the scope or type of work in which the employee may be engaged or requires the employee to transfer, assign, or disclose information concerning his work to anyone other than of the Company.
Tax Periods Beginning Before and Ending After the Closing Date The Company or the Purchaser shall prepare or cause to be prepared and file or cause to be filed any Returns of the Company for Tax periods that begin before the Closing Date and end after the Closing Date. To the extent such Taxes are not fully reserved for in the Company’s financial statements, the Sellers shall pay to the Company an amount equal to the unreserved portion of such Taxes that relates to the portion of the Tax period ending on the Closing Date. Such payment, if any, shall be paid by the Sellers within fifteen (15) days after receipt of written notice from the Company or the Purchaser that such Taxes were paid by the Company or the Purchaser for a period beginning prior to the Closing Date. For purposes of this Section, in the case of any Taxes that are imposed on a periodic basis and are payable for a Taxable period that includes (but does not end on) the Closing Date, the portion of such Tax that relates to the portion of such Tax period ending on the Closing Date shall (i) in the case of any Taxes other than Taxes based upon or related to income or receipts, be deemed to be the amount of such Tax for the entire Tax period multiplied by a fraction the numerator of which is the number of days in the Tax period ending on the Closing Date and the denominator of which is the number of days in the entire Tax period (the “Pro Rata Amount”), and (ii) in the case of any Tax based upon or related to income or receipts, be deemed equal to the amount that would be payable if the relevant Tax period ended on the Closing Date. The Sellers shall pay to the Company with the payment of any taxes due hereunder, the Sellers’ Pro Rata Amount of the costs and expenses incurred by the Purchaser or the Company in the preparation and filing of the Tax Returns. Any net operating losses or credits relating to a Tax period that begins before and ends after the Closing Date shall be taken into account as though the relevant Tax period ended on the Closing Date. All determinations necessary to give effect to the foregoing allocations shall be made in a reasonable manner as agreed to by the parties.
Joint Remediation Committee If the Sellers (acting reasonably) determine that the Purchasers have committed a Major Default, then, at the election of the Sellers, within three (3) Business Days of the Sellers providing the Purchasers written notice of such determination, the Sellers and the Purchasers shall establish a joint remediation committee of designated executives from the Sellers and the Purchasers (“Joint Remediation Committee”) consisting of three (3) members of each of the Sellers and the Purchasers. The Joint Remediation Committee shall be responsible for overseeing the development of a mutually agreeable plan in accordance with subsection 3 below to either (i) remediate any breaches giving rise to the Major Default to the extent such breaches can be remediated and/or (ii) prevent similar breaches from recurring in the future (clauses (i) and (ii), a “Corrective Action Plan”). Each member of the Joint Remediation Committee shall have sufficient authority on the part of his or her respective party to make decisions relating to matters reviewed by the Joint Remediation Committee, and shall be approved by the other party (such approval not to be unreasonably delayed, conditioned or withheld). The Joint Remediation Committee shall have access to Purchaser Personnel that are primarily responsible for the area of the business relationship (such as information technology, data security or regulatory) where the breaches giving rise to the Major Default arise (such Purchaser Personnel, collectively, the “Subject Matter Experts”). The Sellers and the Purchasers shall cause their respective members on the Joint Remediation Committee to, and the Purchasers shall cause the Subject Matter Experts to, act in good faith in connection with the development of the Corrective Action Plan.
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.
Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.
Forecasts and Purchase Orders On or before the twelfth (12th) day of each month, beginning on January 12, 2022, Indivior shall furnish to Curia a written twelve (12) month rolling forecast of the quantities of Product that Indivior intends to order from Curia during such period ("Rolling Forecast"). The first six (6) months of such Rolling Forecast shall constitute a firm and binding commitment to order quantities of Product specified therein ("Firm Period Forecast"), and the following six (6) months of the Rolling Forecast shall be non-binding, good faith estimates. Each month of the Rolling Forecast shall begin on the twelfth (12th) of the calendar month in which such Rolling Forecast is submitted and end on the eleventh (11th) day of the following calendar month. With exception to the Firm Period Forecast, Curia reserves the right to reject any Rolling Forecast that does not align with the physical Processing capabilities of the Facility(ies) and the parties shall work in good faith to adjust the Rolling Forecast based on available resources, Facility capacity and other relevant factors. Indivior shall have the right to request an increase of the Firm Period Forecast to include additional units of Product. Curia may, in its sole discretion, supply such additional quantities, subject to Curia's other supply commitments and manufacturing capacity. In the event Curia agrees to supply such additional quantities, Indivior shall submit a Purchase Order for such additional quantities, with the required lead times as specified below. In no event shall Curia's inability to fulfill Purchase Orders for quantities in excess of the Firm Period Forecast be deemed a breach of this Agreement, nor relieve Indivior of its obligations under this Agreement. Indivior shall submit with each Rolling Forecast, a non-cancelable Purchase Order for the Firm Period Forecast (or such portion of the Firm Period Forecast not covered by previously submitted Purchase Orders). Indivior may alternatively submit Purchase Orders for certain portions of the Firm Period Forecast subsequent to the submission of the Rolling Forecast, provided the Purchase Orders provide the required lead time for Processing as set forth below. Curia shall notify Indivior of acceptance of the Rolling Forecast and any Purchase Order within seven (7) business days of receipt. Curia shall be deemed to have accepted Purchase Orders which it does not acknowledge within seven (7) business days of receipt. Curia shall have the right to reject Rolling Forecasts and Purchase Orders that are inconsistent with this Agreement. Each Purchase Order shall specify the quantity of Product being ordered, and the desired delivery date. Upon mutual agreement in writing for additional quantities of Product beyond the Firm Period Forecast, including projected delivery date(s), Indivior shall issue the applicable Purchase Order to be accepted by Curia as described above. Once placed, all Purchase Orders for Product shall be non-cancelable. No different or additional terms or conditions set forth in any Purchase Order shall modify in any way the terms and conditions of this Agreement, and in the event of a conflict between terms in any Purchase Order and this Agreement, the terms of this Agreement shall control. All Purchase Orders submitted in accordance with the terms of this Agreement shall be effective and binding on the parties upon acceptance by Curia. Except as otherwise provided herein, neither party shall have the right or power to refuse, reduce, or otherwise modify their obligations under any Purchase Order; however, Purchase Orders may be amended (i) upon written mutual agreement regarding such modification that is signed by both parties; or (ii) as otherwise provided in this Section 4.3 or Section 4.4.
