Product Release Statement Sample Clauses

Product Release Statement. CytoDyn shall provide Vyera with a release statement signed and dated by CytoDyn indicating that the Product: (a) meets the Product Specifications; (b) was Manufactured in accordance with cGMPs, BLA, Applicable Laws, DMF (if applicable), the CytoDyn Know-How, and the controlled Validated process; and (c) used only Materials that met their specifications. CytoDyn shall not Deliver Product unless and until such Product has been quality released by CytoDyn. It is also CytoDyn’s responsibility at its own cost to collect all necessary information for the Annual Reports for FDA. The copy of each Annual Report to be provided to Vyera.
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Related to Product Release Statement

  • Complete Release Executive agrees to release EDS from all claims or demands Executive may have against EDS, including, but not limited to, any claims related to Executive's employment with EDS or separation from that employment and any claims for attorney's fees and costs. This Agreement includes, without limitation, a release of any rights or claims Executive may have under the Age Discrimination in Employment Act, as amended, which prohibits age discrimination in employment; Title VII of the Civil Rights Act of 1964, as amended, which prohibits discrimination in employment based on race, color, national origin, religion or sex; the Americans with Disabilities Act, as amended, which prohibits discrimination against individuals with disabilities; the Fair Labor Standards Act, as amended, which regulates matters regarding compensation; the Family and Medical Leave Act, as amended, which regulates matters regarding certain types of leaves; or any other federal, state or local laws or regulations that in any way relate to the employment of individuals and/or prohibit employment discrimination of any form. This Agreement also includes, without limitation, a release by Executive of any related or unrelated wrongful discharge claims, contractual claims, tort claims or any other actions. This Agreement covers both claims that Executive knows about and those he/she may not know about. Executive expressly waives any right to assert after signing this Agreement that any claim, demand, obligation, or cause of action has through ignorance, oversight, or for any other reason, been omitted from the scope of Subsection 5 of Section III of this Agreement. Executive further promises never to file a lawsuit, demand, action or otherwise assert any claims that are released in Subsection 5 of Section III of this Agreement (excluding a lawsuit filed by Executive solely for purposes of challenging the validity of the Age Discrimination in Employment Act waiver). This Agreement does not include a release of (i) Executive's right, if any, to benefits Executive may be entitled to under any EDS plan qualified under Section 401(a) of the Internal Revenue Code, including the EDS Retirement Plan and EDS 401(k) Plan, and COBRA benefits pursuant to Internal Revenue Code section 4980B, (ii) any rights or claims Executive may have under the Age Discrimination in Employment Act which arise after the date Executive signs this Agreement, (iii) any rights pursuant to this Agreement, (iv) Executive's right, if any, to benefits Executive may be entitled to under the EDS Executive Deferral Plan, (v) any rights pursuant to any indemnification agreements between Executive and EDS, or (vi) Executive's right, if any, to benefits Executive may be entitled to under any applicable directors and officers or other liability insurance policies.

  • Seller Release (a) Each Seller does hereby, on behalf of itself and its agents, representatives, attorneys, assigns, Affiliates, heirs, executors and administrators (collectively, the “Seller Parties”) RELEASE AND FOREVER DISCHARGE Edgen, each of Edgen’s Subsidiaries, the Purchaser and their respective Affiliates, parents, joint ventures, officers, directors, shareholders, members, managers, employees, consultants, representatives, successors and assigns, heirs, executors and administrators (collectively, the “Company Parties”) from all causes of action, suits, debts, claims and demands whatsoever at law, in equity or otherwise, which such Seller or any of the Seller Parties ever had, now has, or hereafter may have, by reason of any matter, cause or thing whatsoever, from the beginning of its initial dealings with Edgen or any of its Subsidiaries to the Closing, and particularly, but without limitation of the foregoing general terms, any claims arising from or relating in any way to such Seller’s status as a stockholder, investor, holder of any equity interests, lender (except as to any such Seller or any of its Affiliates holding Indebtedness of Edgen as set forth on Schedule 4.28 hereto) or debtor of Edgen or any of its Subsidiaries (including any right to indemnification or contribution from Edgen (whether statutory, common law, pursuant to Edgen’s charter documents or otherwise)), any agreement between such Seller, Edgen or any of its Subsidiaries or any Affiliate of Edgen or any of its Subsidiaries, and, if applicable, such Seller’s employment relationship with Edgen or any of its Subsidiaries, but not including such claims to payments, indemnification, contribution and other rights provided to such Seller under this Agreement and the employment agreements or causes of action, suits, debts, claims and demands whatsoever at law, in equity or otherwise, arising from or relating in any way to such Seller Parties’ status as a director, officer, stockholder, investor or holder of any equity interests in connection with the Senior Notes Offering (other than with respect to any untrue statement or alleged untrue statement or omission or alleged omission made in the Senior Notes Offering in reliance upon and in conformity with written information furnished to Purchaser by or on behalf of any member of such Seller Party specifically for inclusion therein, but only with respect to such member of the Seller Party specifically for inclusion therein or in connection with any efforts by any Seller Party to engage in the selling of the notes contemplated by the Senior Notes Offering other than at the express direction of the Purchaser). The release contained in this paragraph (a) is effective without regard to the legal nature of the claims raised and without regard to whether any such claims are based upon tort, equity, implied or express contract or discrimination of any sort.

  • Pre-Release Subject to the further terms and provisions of this Section 2.10, the Depositary, its Affiliates and their agents, on their own behalf, may own and deal in any class of securities of the Company and its Affiliates and in ADSs. In its capacity as Depositary, the Depositary may (i) issue ADSs prior to the receipt of Shares (each such transaction a "Pre-Release Transaction") as provided below and (ii) Deliver Shares upon the receipt and cancellation of ADSs that were issued in a Pre-Release Transaction, but for which Shares may not yet have been received. The Depositary may receive ADSs in lieu of Shares under (i) above and receive Shares in lieu of ADSs under (ii) above. Each such Pre-Release Transaction will be (a) subject to a written agreement whereby the person or entity (the "Applicant") to whom ADSs or Shares are to be Delivered (1) represents that at the time of the Pre-Release Transaction the Applicant or its customer owns the Shares or ADSs that are to be Delivered by the Applicant under such Pre-Release Transaction, (2) agrees to indicate the Depositary as owner of such Shares or ADSs in its records and to hold such Shares or ADSs in trust for the Depositary until such Shares or ADSs are Delivered to the Depositary or the Custodian, (3) unconditionally guarantees to deliver to the Depositary or the Custodian, as applicable, such Shares or ADSs, and (4) agrees to any additional restrictions or requirements that the Depositary deems appropriate, (b) at all times fully collateralized with cash, United States government securities or such other collateral as the Depositary deems appropriate, (c) terminable by the Depositary on not more than five (5) Business Days' notice and (d) subject to such further indemnities and credit regulations as the Depositary deems appropriate. The Depositary will normally limit the number of ADSs and Shares involved in such Pre-Release Transactions at any one time to thirty percent (30%) of the ADSs outstanding (without giving effect to ADSs outstanding under (i) above), provided, however, that the Depositary reserves the right to disregard such limit from time to time as it deems appropriate. The Depositary may also set limits with respect to the number of ADSs and Shares involved in Pre-Release Transactions with any one person on a case by case basis as it deems appropriate. The Depositary may retain for its own account any compensation received by it in conjunction with the foregoing. Collateral provided pursuant to (b) above, but not the earnings thereon, shall be held for the benefit of the Holders (other than the Applicant).

  • Scope of Release The provisions of this Release shall be deemed to obligate, extend to, and inure to the benefit of the parties; the Company’s parents, subsidiaries, affiliates, successors, predecessors, assigns, directors, officers, and employees; and each party’s insurers, transferees, grantees, legatees, agents, personal representatives and heirs, including those who may assume any and all of the above-described capacities subsequent to the execution and Effective Date of this Release.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Quality Service Standards/NAV Errors Price Associates and the Fund may, from time to time, agree to certain quality service standards, with respect to the Services hereunder. In the event Price Associates is the party responsible for causing an error in the computation of the net asset value for a Fund or share class of a Fund (“NAV Error”), the actions that are required to be taken as to such NAV Error shall be made in accordance with the Fund’s Net Asset Value Error Correction Policy and Procedures (“NAV Error Policy”) attached hereto as Schedule II.

  • 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.

  • Delivery Schedule The scheduled months of delivery of the Aircraft are listed in the attached Table 1. Exhibit B describes certain responsibilities for both Customer and Boeing in order to accomplish the delivery of the Aircraft.

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