COMPOUND REQUIREMENTS Sample Clauses

COMPOUND REQUIREMENTS. ○ For the purposes of manufacturing and supply, we are planning supplies for 100 patients to be conservative in case circumstances changed or we had loss of a shipment (60 active, 40 placebo) ○ Safest approach for API planning purposes is to have inventory for both the high and the low dose scenarios for up to 60 active patients. In other words, to plan for 60 at 150 mg, 60 at 100 mg and 40 on placebo. And because we additionally plan on offering the placebo group 12 weeks of open label drug (at 150 or 100 based on safety) in order to help with enrollment, the conservative approach is to have inventory for 100 patients at 150 mg BID, 100 patients at 100 mg BID (which we hope we won’t need to use) and 40 patients worth of placebo. ○ Maximum compound requirements would be: 20,160 150-mg Capsules Needed For High-Dose Scenario: - 100 patients x 2 capsules per day x 84 days = 16,800 capsules - In addition, we need 20% overage for inventory management purposes across sites: + 3,360 capsules - Total: 20,160 capsules 38,640 50-mg Capsules Needed For Low-Dose Scenario: - 100 patients x 4 capsules per day x 84 days = 33,600 capsules [1,680 g] - Since we start with the high-dose, we may not need as much overage as the low-dosse arm would likely enroll less than 60 patients, so let’s say 15% overage, or 5,040 capsules - Total: 38,640 capsules 16,128 Matching Placebo Capsules: - 40 patients x 4 capsules per day (it would be 2/day for high-dose and 4/day for low dose) x 84 days = 13,440 - Then 20% overage = 2,688 - Total = 16,128 capsules Schedule 3: Jxxxxxx Patents Rights Jxxxxxx Internal reference Filing date Filing number Grant date Grant number PRD2892AUPCD1 16/OCT/2008 2013203813 13/NOV/2014 2013203813 PRD2892USPSP 17/OCT/2007 60/980623 PRD2892USNP 16/OCT/2008 12/252439 30/JUL/2013 8497376 PRD2892WOPCT 16/OCT/2008 PXX/XX0000/000000 XXX0000XXXX 16/OCT/2008 P080104507 PRD2892CLNP 16/OCT/2008 3068/08 19/AUG/2014 50.259 PRD2892GCNP 15/OCT/2008 GCC/P/2008/11939 PRD2892JONP 15/OCT/2008 464/2008 PRD2892PKNP 14/OCT/2008 1198/2008 PRD2892PANP 17/OCT/2008 PI/PA01/87997 02/NOV/2009 87997 PRD2892PENP 17/OCT/2008 1797/2008-OIN 22/MAR/2013 6786 PRD2892TWNP 16/OCT/2008 97139644 11/JUN/2014 I440637 PRD2892THNP 16/OCT/2008 0000000000 PRD2892UYNP 16/OCT/2008 31397 PRD2892VENP 17/OCT/2008 2008-002114 PRD2892EPEPT 16/OCT/2008 08839490.3 PRD2892EAEAT 16/OCT/2008 201070480 29/NOV/2013 018936 PRD2892AUPCT 16/OCT/2008 2000000000 10/JUL/2014 2000000000 PRD2892BRPCT 16/OCT/2008 PI0817843-7 ...
Sample 1
AutoNDA by SimpleDocs
COMPOUND REQUIREMENTS. The Supply Agreement shall provide that VRI shall manufacture or have manufactured and LICENSEE shall purchase from VRI, LICENSEE's entire requirements of COMPOUND (clinical lots as well as commercial lots) for PRODUCTS and that LICENSEE shall purchase such COMPOUND for its own use in manufacturing PRODUCTS only and shall not be permitted to sell or re-sell COMPOUND to any Third-Party.
Sample 1

Related to COMPOUND REQUIREMENTS

  • Distribution Requirements Subject to the Alternative Election or Spouse Beneficiary provisions below,

  • Rule 144 Requirements After the earliest of (i) the closing of the sale of securities of the Company pursuant to a Registration Statement, (ii) the registration by the Company of a class of securities under Section 12 of the Exchange Act, or (iii) the issuance by the Company of an offering circular pursuant to Regulation A under the Securities Act, the Company agrees to:

  • Sublicense Requirements Any Sublicense:

  • Tests Based on the AUPs, the Asset Representations Reviewer shall review the Required Documents to determine whether, for each Reviewable Receivable, (a) there was evidence that the applicable Test for such Reviewable Receivable was satisfied, (b) there was evidence that the applicable Test for such Reviewable Receivable was not satisfied or (c) the Test could not be completed as a result of missing or insufficient Required Documents for a Reviewable Receivable. Each Test shall be performed individually. The Asset Representations Reviewer may, at its sole discretion, review additional information that is not required for the Asset Representations Review as defined by the AUPs, but it is not required to do so.

  • REIT Distribution Requirements The General Partner shall use its commercially reasonable efforts to cause the Partnership to distribute amounts sufficient to enable the General Partner to make stockholder distributions that will allow the General Partner to (i) meet its distribution requirement for qualification as a REIT as set forth in Section 857 of the Code and (ii) avoid any federal income or excise tax liability imposed by the Code.

  • Filing Requirements From the date of this Agreement and until the last to occur of (i) all the Conversion Shares have been resold or transferred by the Subscribers pursuant to a registration statement or pursuant to Rule 144(b)(1)(i), or (ii) none of the Notes and Warrants are outstanding (the date of such latest occurrence being the “End Date”), the Company will (A) cause its Common Stock to continue to be registered under Section 12(b) or 12(g) of the 1934 Act, (B) comply in all respects with its reporting and filing obligations under the 1934 Act, (C) voluntarily comply with all reporting requirements that are applicable to an issuer with a class of shares registered pursuant to Section 12(g) of the 1934 Act, if the Company is not subject to such reporting requirements, and (D) comply with all requirements related to any registration statement filed pursuant to this Agreement. The Company will use its commercially reasonable best efforts not to take any action or file any document (whether or not permitted by the 1933 Act or the 1934 Act or the rules thereunder) to terminate or suspend such registration or to terminate or suspend its reporting and filing obligations under said acts until the End Date. Until the End Date, the Company will continue the listing or quotation of the Common Stock on a Principal Market and will comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the Principal Market. The Company agrees to timely file a Form D with respect to the Securities if required under Regulation D and to provide a copy thereof to each Subscriber promptly after such filing.

  • Technical Requirements All Corrections done by Customer, its Authorized Agent or a third party contractor must be performed in accordance with Boeing's applicable service manuals, bulletins or other written instructions, using parts and materials furnished or approved by Boeing.

  • FINRA Requirements (A) You represent that you are a member in good standing of FINRA, or a non-U.S. bank, broker, dealer, or institution not eligible for membership in FINRA or a Bank.

  • Additional Reserve Requirements The Company shall pay (or cause the applicable Designated Borrower to pay) to each Lender, (i) as long as such Lender shall be required to maintain reserves with respect to liabilities or assets consisting of or including Eurocurrency funds or deposits (currently known as “Eurocurrency liabilities”), additional interest on the unpaid principal amount of each Eurocurrency Rate Loan equal to the actual costs of such reserves allocated to such Loan by such Lender (as determined by such Lender in good faith, which determination shall be conclusive), and (ii) as long as such Lender shall be required to comply with any reserve ratio requirement or analogous requirement of any other central banking or financial regulatory authority imposed in respect of the maintenance of the Commitments or the funding of the Eurocurrency Rate Loans, such additional costs (expressed as a percentage per annum and rounded upwards, if necessary, to the nearest five decimal places) equal to the actual costs allocated to such Commitment or Loan by such Lender (as determined by such Lender in good faith, which determination shall be conclusive), which in each case shall be due and payable on each date on which interest is payable on such Loan, provided the Company shall have received at least 10 days’ prior notice (with a copy to the Administrative Agent) of such additional interest or costs from such Lender. If a Lender fails to give notice 10 days prior to the relevant Interest Payment Date, such additional interest or costs shall be due and payable 10 days from receipt of such notice.

  • Reporting Requirements The Company, during the period when the Prospectus is required to be delivered under the 1933 Act or the 1934 Act, will file all documents required to be filed with the Commission pursuant to the 1934 Act within the time periods required by the 1934 Act and the 1934 Act Regulations.

Time is Money Join Law Insider Premium to draft better contracts faster.