NOVAVAX Products. Throughout the Term, KING shall provide NOVAVAX with a report within thirty (30) calendar days after the end of each calendar quarter, with the first such report due for the calendar quarter during which the NOVAVAX Product Initiation Date occurs, setting forth the following information regarding the efforts of KING's sales force in promoting and Detailing the NOVAVAX Products during the preceding quarter (or part thereof): (i) the number of Details made and recorded by KING's standard record keeping procedures based on data recorded by the sales force; (ii) the names, addresses and phone numbers of the OB/GYN's called upon; (iii) the names of and the percentage of OB/GYN's Detailed who were provided with samples of the NOVAVAX Products; (iv) the actual number of such samples delivered on each Detail; and (v) such other information as may be required in the then current Marketing Plan.
NOVAVAX Products. NOVAVAX shall provide KING, from time to time on a schedule and in such quantities to be reasonably determined by the PMC, with samples of the NOVAVAX Products to be used by KING solely in marketing and promoting the Copromote Products in the Territory, in accordance with the then current Marketing Plan. NOVAVAX shall ship the samples to one central warehouse of KING, as designated by KING, and the risk of loss and responsibility for handling and warehousing of the samples shall pass to KING upon delivery to a carrier designated by KING. KING shall be responsible for distributing the samples to its sales representatives in a timely manner. KING shall also be responsible for securing the return of and reconciling existing sample inventories from its discontinued field sales representatives. All samples of the NOVAVAX Products provided to KING hereunder shall be accompanied by an appropriate Certificate of Analysis of the NOVAVAX Product specifications and an indication of expiration dating.
NOVAVAX Products. All regulatory matters regarding the NOVAVAX Products shall remain under the control of NOVAVAX, subject to the participation by KING in matters related to the marketing of the NOVAVAX Products to OB/GYN's in the Territory. Notwithstanding the foregoing, NOVAVAX shall promptly provide KING with copies of all communications received from any regulatory agency or authority concerning the NOVAVAX Products or any Marketing Materials related to the NOVAVAX Products and shall submit copies of all such communications and filings to be made to any
NOVAVAX Products. NOVAVAX shall furnish KING with efficacy and safety information in its possession as reasonably requested by KING to assist KING in promoting the NOVAVAX Products to OB/GYN's in the Territory, including without limitation relevant clinical and safety data included in the NDA for the NOVAVAX Products and additional information, if any, related to the efficacy and safety profile of the NOVAVAX Products. Except for that information that is to be disclosed to OB/GYN's in connection with conducting Details, such information shall be treated as Confidential and Proprietary Information pursuant to Section 12 of this Agreement and shall not be disclosed to third parties without NOVAVAX's prior written approval or direction.
NOVAVAX Products. Serious Adverse Events for the NOVAVAX Products learned of by KING shall be submitted in writing to NOVAVAX within two (2) business days from the date of learning thereof by KING. Non-Serious Adverse Events for the NOVAVAX Products learned of by KING shall be submitted in writing to NOVAVAX no more than five (5) business days from the date of learning thereof by KING. NOVAVAX and/or its Affiliates shall have the sole responsibility for reporting and responding to such events to applicable regulatory authorities in the Territory; provided, that KING may take such actions (including issuing such reports) as it determines is required by applicable law. NOVAVAX shall promptly provide KING with copies of all periodic reports and product safety update reports relating to the NOVAVAX Products which are filed or received from third parties. Notwithstanding the foregoing, within one hundred twenty (120) days after the Effective Date, the parties shall meet and establish a standard operating procedure ("SOP") addressing the responsibilities of each party with respect to adverse event reporting, which SOP shall supercede this Section 7.4, it being understood, however, that with regard to the NOVAVAX Products, NOVAVAX shall have the responsibility of reporting all adverse events to the appropriate regulatory authorities.
NOVAVAX Products. NOVAVAX shall have the sole authority and responsibility to respond to any regulatory agencies, including without limitation the FDA, to respond to NOVAVAX Product Technical Complaints and medical complaints and to handle all returns, recalls or market withdrawals of the NOVAVAX Products in accordance with applicable law, at NOVAVAX's cost and expense; provided, however, that if any such returns, recalls or market withdrawals of the NOVAVAX Products are caused solely by actions or inactions by KING constituting a breach of the provisions of this Agreement or a violation of applicable law, KING, as NOVAVAX's sole remedy, shall bear all reasonable Direct Costs associated with such actions or inactions in connection therewith, provided, however, that KING shall have no obligation to reimburse NOVAVAX for any incidental or consequential damages incurred in connection therewith, including, without limitation, any lost profits. Prior to the NOVAVAX Product Initiation Date, the PMC shall adopt an SOP for handling NOVAVAX Product Technical Complaints, medical inquiries and adverse event information received by the parties not otherwise specified in this Agreement. The PMC shall revise the SOP from time to time during the Term as the PMC deems necessary.
NOVAVAX Products. NOVAVAX shall handle all medical inquiries concerning the NOVAVAX Products. KING shall refer all medical information requests and/or medical inquiries to NOVAVAX in accordance with the procedures set forth in the SOP referred to in Section 7.5.
NOVAVAX Products. Within forty-five (45) days after the end of each calendar quarter during the Term, NOVAVAX shall pay to KING (by wire transfer of immediately available funds to an account designated by KING to NOVAVAX in writing) an amount ("NP Consideration Fee") equal to fifty percent (50%) of the Net Sales of the NOVAVAX Products in the Territory during such quarter minus fifty percent (50%) of the Net Costs of NOVAVAX Products in the Territory during such quarter; provided, however, that NOVAVAX shall be solely responsible for the Net Costs of NOVAVAX Products to the extent that such Net Costs, as a percentage of Net Sales, exceed seventeen percent (17%)
NOVAVAX Products. NOVAVAX shall initially pay for all Marketing as such Marketing Expenses are incurred for NOVAVAX Products and shall keep accurate and reasonably detailed records of such payments. NOVAVAX shall provide KING with a weekly update of an estimate of the Marketing Expenses and other PMC approved miscellaneous expenses incurred by NOVAVAX during the previous week within fifteen (15) days after the end of each month. NOVAVAX shall provide KING with a detailed statement of Marketing Expenses and other PMC-approved miscellaneous expenses incurred during such month along with an invoice for KING's share thereof, which invoice will be payable, less any credits for Marketing Expenses and other PMC-approved miscellaneous expenses incurred and paid by KING within fifteen (15) days of KING's receipt thereof. KING shall also provide NOVAVAX with a weekly update of an estimate of the Marketing Expenses and other PMC approved miscellaneous expenses incurred and paid (other than to NOVAVAX) by it during the previous week and within fifteen (15) days after the end of each month, KING shall provide NOVAVAX with a detailed statement of all Marketing Expenses and other PMC-approved miscellaneous expenses incurred by KING during such month. Within thirty (30) days after the end of each calendar quarter during the Term, NOVAVAX shall prepare a reconciliation statement of Marketing Expenses incurred by each party during such calendar quarter. If such reconciliation statement shall show that either party reasonably incurred and paid Marketing Expenses and other PMC-approved miscellaneous costs and expenses in excess of the amount payable by such party, and that the other party incurred and paid Marketing Expenses below
NOVAVAX Products. Upon the termination or expiration of this Agreement for any reason with respect to the NOVAVAX Products, KING shall immediately cease all of its promotional and marketing activities for the terminated NOVAVAX Products, discontinue any use of the NOVAVAX Trademarks related to the terminated NOVAVAX Products, and return to NOVAVAX or destroy all sales training and Marketing Materials for the terminated NOVAVAX Products containing NOVAVAX Trademarks and any remaining terminated NOVAVAX Products samples (not already distributed or destroyed with destruction certified by KING). After any termination NOVAVAX shall retain the right to use any sales training and Marketing Materials developed under the auspices of the PMC during the Term of this Agreement, provided, however, that NOVAVAX shall have no further right to use KING's name or any KING Trademark or logos in connection therewith.
