Common use of Records; Audit Rights Clause in Contracts

Records; Audit Rights. Client will keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.

Appears in 4 contracts

Sources: Zydis Development and License Agreement, Zydis Development and License Agreement (Biohaven Pharmaceutical Holding Co Ltd.), Zydis Development and License Agreement (Biohaven Pharmaceutical Holding Co Ltd.)

Records; Audit Rights. Client (a) Seller will, and will cause its Affiliates, licensees and sublicensees to keep complete and accurate books maintain, for a period of [***] ([***]) Calendar Years from the end of an applicable Calendar Year, accounts and records relating of all data reasonably required (i) to all amounts verify Product Payments, Royalty Reports and the Purchased Royalty payable to Catalent Purchaser hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductionsii) and is achievement to verify the use of the milestone events referred to in Section 4.1(DPurchase Price proceeds by Seller. (b) During the Term and for at least [* * ***] years after the expiration of the year to which they relate([***]) Calendar Years thereafter, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours and upon at least [***] ([***]) days’ prior written notice to appropriate space at ClientSeller, Purchaser shall have the right to audit on a Calendar Year basis, through an independent certified public accountant selected by Purchaser that is reasonably acceptable to Seller (which acceptance will not be unreasonably withheld, conditioned or delayed), those accounts and records of Seller and Seller’s relevant location and to such of the pertinent Records of Client Affiliates as may be reasonably necessary to verify the matters accuracy of the Royalty Reports and the amounts paid by Seller to Purchaser under this Agreement (provided, however, that, prior to conducting any such audit, such accountant will have entered into a confidentiality agreement in questionform and substance reasonably satisfactory to Seller). Such access shall include the right of Catalent The records with respect to a particular Calendar Year may not be audited more than once or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * ***] years prior ([***]) Calendar Years after the Calendar Year to the date of which such requestrecords relate. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary The selected accountant will keep confidential all information except as contemplated by this Agreement. Prior to disclosing the results of any obtained during such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent issue a written report stating whether to Purchaser and to Seller with only (i) the payments made to Catalent actual amount of Product Net Sales for the audit period are correct Calendar Year(s) in question, (ii) the actual amount of Product-Related Damages received by Seller during the Calendar Year(s) in question, (iii) the resulting over- or incorrect under payment of Purchased Royalty to Purchaser that occurred during the Calendar Year(s) in question, and (iv) the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be discrepancies between the Purchased Royalty that was paid to Catalent within [* * *] days after Purchaser and the date Client receives the auditors’ final written reportPurchased Royalty that should have been paid to Purchaser. Any fees and expenses The results of the audit shall be paid by Catalent binding on the Parties absent material error. (c) Purchaser is solely responsible for all the expenses of the independent certified accountant, unless the audit discloses an understatement independent certified public accountant’s report (or subsequent dispute resolution, if Seller disputes such report) shows any underpayment by Client Seller exceeding [***] percent ([***]%) of the payment owed to Purchaser for any of the Calendar Years then being reviewed. If the independent certified public accountant’s report (or subsequent dispute resolution, if Seller disputes such report) shows that Seller underpaid Purchaser by more than [* * ***] percent ([***]% %), Seller shall be responsible for the reasonable expenses incurred by Purchaser for the independent certified public accountant’s services for such audit. Any payment owed by one Party to any other as a result of the aggregate audit shall be made within [***] ([***]) Business Days of the receipt of the audit report, free and clear of any and all Encumbrances; provided, that in lieu of receiving payment for an overpayment of the Purchased Royalty by Seller, Seller shall credit such overpayment against future amounts payable owed to Catalent pursuant to Purchaser under this Agreement during such audit periodAgreement. In addition, in which case Client any payment under this Section 2.6 shall bear the responsibility for any such reasonable fees and expensesinterest in accordance with Section 2.8.

Appears in 3 contracts

Sources: Purchase and Sale Agreement (Galera Therapeutics, Inc.), Purchase and Sale Agreement (Galera Therapeutics, Inc.), Purchase and Sale Agreement

Records; Audit Rights. Client will keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D3.1(A) for at least [* * *] 3 years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar yeartwelve month period, Catalent shall be entitled to audit, or to have an independent accountant acceptable to Client audit, such books and recordsrecords solely related to calculations of Net Sales for the previous twelve month period. Upon reasonable advance notice, Client shall provide Catalent or such auditors, as applicable, the auditors with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records books and records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination Auditors shall be limited required to pertinent Records for any year ending not more than [* * *] years sign Client’s standard confidential disclosure agreement prior to the date of such request. Before permitting such independent accounting firm to have being allowed access to such Records books and personnel, records. Catalent shall indemnify and hold Client may require harmless for any action or activity of such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing auditors while on Client’s financial and proprietary information except as contemplated by this Agreementpremises. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days an opportunity to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepanciesidentified. If an audit discloses an underpayment or overpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent Catalent, or in the case of an overpayment credited to Client, within [* * *] 30 days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]3% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit periodAgreement, in which case Client shall bear the responsibility for any such reasonable fees and expenses.

Appears in 2 contracts

Sources: Gpex® Derived Cell Line Sale Agreement (DiaMedica Therapeutics Inc.), Gpex® Derived Cell Line Sale Agreement (DiaMedica Therapeutics Inc.)

Records; Audit Rights. Client will Each party shall keep complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters accuracy and completeness of all activities in questionconnection with this Agreement, including without limitation, inventory, shipping and delivery, storing, handling, transport, costs, sales, purchase and invoice records relating to the Product. Such access books and records shall include be preserved for a period not less than ten (10) years after they are created during and after the right Term. Either party may, upon not less than fifteen (15) business days advance written notice, audit all the books and records of Catalent the other party relating to this Agreement at a single United States location to verify the accuracy of such party's accounting. Any audit performed pursuant to this Section 3.8 shall be at expense of the party conducting such audit, unless it reveals a underpayment or overpayment of five per cent (5%) or more in favor of the independent accounting firm to interview Catalent’s personnel audited party for any Contract year, in which case the audited party shall reimburse the auditing party for the actual costs of such audit. Such audit may be performed by any employee of the requesting party as Catalent well as by any attorney or licensed certified public accountant designated by the requesting party, upon not less than fifteen (15) business days advance notice, during regular business hours, and in a manner that shall not unreasonably interfere with such independent accounting firm determines appropriateparty's normal business operations. Each party shall conduct no more than one (1) audit during any Contract Year, PROVIDED, HOWEVER, that such examination audit shall not be limited to the current Contract Year, but shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date period since the completion of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such the immediately preceding audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepanciesif any. If an audit discloses an reveals any underpayment by Client OMP to LifeCell, OMP shall pay LifeCell the amount of any amounts paid such [***] Material has been omitted pursuant to any provision a request for confidential treatment and such material has been filed separately with the Securities and Exchange Commission. underpayment within five (5) days of this Agreement, written notification of such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written reportunderpayment. Any fees and expenses of If the audit shall be paid by Catalent unless reveals that OMP has made an overpayment to LifeCell, the audit discloses an understatement by Client amount overpaid will be, at the option of more than [* * *]% of OMP, returned forthwith to OMP or credited to the aggregate amounts payable to Catalent pursuant to this Agreement during next such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensespayment or payments due OMP from LifeCell.

Appears in 2 contracts

Sources: Co Promotion Agreement (Omp Inc), Co Promotion Agreement (Omp Inc)

Records; Audit Rights. Client will Cara and its Affiliates and Sub-licensees shall keep and maintain, for [***] from the date of (x) each payment of royalties under this Agreement and (y) each milestone owed, complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Cara and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseits Affiliates and Sub-licensees, in sufficient detail to enable allow royalties and milestones on Net Sales to be determined accurately. All such records required to be maintained under this Section 6.7 shall include the calculation information contained in the reports required under Section 6.6. Enteris shall have the right for a period of [***] after receiving any such payments to appoint at its expense an independent certified public accountant reasonably acceptable to Cara to audit such records of Cara, or its Affiliates, to verify that the amount of any such payment was correctly determined. Cara and verification of all payments payable to Catalent hereunder (“Records”)its Affiliates shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon [***] written notice from Enteris. Upon the written request and Such audit right shall not be exercised by Enteris more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Product in a particular period or with respect to an individual milestone. All records made available for audit shall be entitled deemed to be Confidential Information of Cara. The results of each audit, or to have if any, shall be binding on both Parties absent manifest error. In the event there was an independent accountant auditunderpayment by Cara under this Agreement, such books and records. Client Cara shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than [***] after Cara’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to Enteris of Client any shortfall together with interest as may be reasonably necessary to verify provided in Section 6.8 from the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or date such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior payment was due to the date paid in full. Enteris shall bear the full cost of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any audit unless such audit discloses a variance to Catalent, the auditors shall present Client with a preliminary report detriment of findings and provide Client with up to [* * *] days to respond to any questions raised Enteris of five percent 5% or issues identified (more from the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses amount of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, original payment calculation in which case Client Cara shall bear all reasonable cost of the responsibility for any performance of such reasonable fees and expensesaudit.

Appears in 2 contracts

Sources: Non Exclusive License Agreement (SWK Holdings Corp), Non Exclusive License Agreement (Cara Therapeutics, Inc.)

Records; Audit Rights. Client will AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall) keep complete and accurate books maintain for [********] from the date of each payment of royalties hereunder (or such longer period as may be required by Applicable Law) records of AZ Net Sales by AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product in sufficient detail to allow royalties to be determined accurately. Targacept shall have the right for a period of [********] after receiving any such payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to AstraZeneca to inspect or audit, the relevant records relating of AstraZeneca and its Affiliates to all amounts payable verify that the amount of such payment was correctly determined. AstraZeneca and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Targacept, solely to Catalent hereunder, verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by Targacept more than [********] in any Calendar Year more than [********] with respect to sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to a particular Product in Section 4.1(D) for at least a particular period or more than [* * ********] years after the expiration end of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)such period. Upon the written request and not more than once per calendar year, Catalent All records made available for inspection or audit shall be entitled deemed to audit, or to have an independent accountant audit, such books be Confidential Information of AstraZeneca and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to any such inspection or audit the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved accountant shall enter into a non-disclosure agreement in such audit, to sign to sign a confidentiality agreement form reasonably acceptable to Catalent to prohibit the independent AstraZeneca. The accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior shall disclose to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating Parties whether the payments made to Catalent for the audit period royalty reports are correct or incorrect and the specific details of concerning any discrepancies. If No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment by AstraZeneca hereunder, AstraZeneca shall promptly (but in any event no later than [********] after AstraZeneca’s receipt of the report so concluding) make payment to Targacept of any shortfall. In the event that there was an overpayment by AstraZeneca hereunder, Targacept shall promptly (but in any event no later than [********] after Targacept’s receipt of the independent accountant’s report so concluding) refund to AstraZeneca the excess amount. Targacept shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client AstraZeneca of more than [* * *]% *******] of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client AstraZeneca shall bear the responsibility reimburse Targacept for any all costs incurred by Targacept in connection with such reasonable fees and expensesinspection or audit.

Appears in 2 contracts

Sources: Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc)

Records; Audit Rights. Client will AstraZeneca shall (and shall use reasonable efforts to ensure that its Affiliates and Sublicensees shall) keep complete and accurate books maintain for [********] from the date of each payment of royalties hereunder (or such longer period as may be required by Applicable Law) records of AZ Net Sales by AstraZeneca, its Affiliates and Sublicensees (as the case may be) of each Product in sufficient detail to allow royalties to be determined accurately. Targacept shall have the right for a period of [********] after receiving any such payment to inspect or audit, or to appoint at its expense an independent certified public accountant reasonably acceptable to AstraZeneca to inspect or audit, the relevant records relating of AstraZeneca and its Affiliates to all amounts payable verify that the amount of such payment was correctly determined. AstraZeneca and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from Targacept, solely to Catalent hereunder, verify that royalty payments hereunder were correctly determined. Such inspection or audit right shall not be exercised by Targacept more than [********] in any Calendar Year more than [********] with respect to sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to a particular Product in Section 4.1(D) for at least a particular period or more than [* * ********] years after the expiration end of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)such period. Upon the written request and not more than once per calendar year, Catalent All records made available for inspection or audit shall be entitled deemed to audit, or to have an independent accountant audit, such books be Confidential Information of AstraZeneca and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to any such inspection or audit the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved accountant shall enter into a non-disclosure agreement in such audit, to sign to sign a confidentiality agreement form reasonably acceptable to Catalent to prohibit the independent AstraZeneca. The accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior shall disclose to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating Parties whether the payments made to Catalent for the audit period royalty reports are correct or incorrect and the specific details of concerning any discrepancies. If an audit discloses No other information shall be provided to Targacept. The results of each inspection or audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment by Client of AstraZeneca hereunder, AstraZeneca shall promptly (but in any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within event no later than [* * ********] days after the date Client receives the auditors’ final written report. Any fees and expenses AstraZeneca’s receipt of the audit shall be paid by Catalent unless the audit discloses an understatement by Client report so concluding) make payment to Targacept of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expenses.any

Appears in 1 contract

Sources: Collaborative Research and License Agreement (Targacept Inc)

Records; Audit Rights. Client will Tyligand and its Affiliates shall keep and maintain for [***] years from the date of each payment of royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by Tyligand and is achievement its Related Parties of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable the calculation and verification of all payments payable allow royalties to Catalent hereunder (“Records”)be accurately determined. Upon the written request and not more than once per calendar year, Catalent Context shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right for a period of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * ***] years prior after receiving any such royalty payment to appoint an independent certified public accountant reasonably acceptable to Tyligand to audit the date relevant records of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm Tyligand and its personnel involved in Affiliates to verify that the amount of each such auditpayment was correctly determined; provided, that, (i) if requested by Tyligand, Context shall cause the independent certified public accountant to sign to sign enter into a confidentiality agreement reasonably acceptable to Catalent Tyligand and (ii) such independent certified public accountant may only disclose to prohibit Context whether the royalties are correct and the details with respect to any discrepancies. Tyligand and its Affiliates shall each make its records available for audit by such independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any certified public accountant during regular business hours at such audit to Catalentplace or places where such records are customarily kept, the auditors shall present Client with a preliminary report of findings and provide Client with up to upon [* * ***] days written notice from Context. Such audit right shall not be exercised by Context more than once in any Calendar Year or more than once with respect to respond sales of a particular Product in a period previously audited by Context. All records made available for audit shall be deemed to be Confidential Information of Tyligand. The results of each audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment of royalties by Tyligand hereunder, Tyligand shall promptly (but in any questions raised or issues identified (event no later than [***] days after Tyligand’s receipt of the “Review Period”). Following the Review Period, the auditors will prepare and provide report so concluding) make payment to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details Context of any discrepanciesshortfall. If an Context shall bear the full cost of such audit unless such audit discloses an underpayment by Client Tyligand of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * ***] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of or more than [* * *]% of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client Tyligand shall bear reimburse Context for the responsibility reasonable costs of the certified public accountant who conducted the audit in connection with such audit. In the event such accounting determines that Tyligand paid Context more than the amount properly due in respect of any Calendar Quarter, then any excess payments made by Tyligand will be credited against future amounts due to Context from Tyligand, or if no such future amounts are reasonably expected to be due to Context from Tyligand, then Context will reimburse Tyligand for any such reasonable fees and expensesoverpayment by Tyligand.

Appears in 1 contract

Sources: License, Development, Manufacturing & Marketing Agreement (Context Therapeutics Inc.)

Records; Audit Rights. Client will (a) Genentech shall keep complete full, true and accurate books of account containing all particulars which may be necessary for the purpose of showing Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and records relating to Third Party Manufacturing Royalties. Said books of account shall be kept at the principal place of business of Genentech. Said books and the supporting data shall be open at all amounts payable to Catalent hereunderreasonable times, sales of Products, its calculation of royalties and Net Sales for three (including all relevant deductions3) and is achievement years following the end of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the calendar year to which they relatepertain (and access shall not be denied thereafter, in each caseif reasonably available), in sufficient detail to enable the calculation and verification inspection of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent public accountant audit, such books retained by Connetics and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit Genentech for the independent accounting firm from disclosing Client’s financial purpose of verifying Fully Burdened Manufacturing Cost, Fully Burdened Supply Cost and proprietary information except as contemplated by Third Party Manufacturing Royalties under this Agreement; provided, however, that Connetics shall give Genentech reasonable prior notice of such review by Connetics' independent public accountant and that such review shall not take place more often than once a year. Prior If such review reveals that Connetics has overpaid Genentech for Bulk Product or Finished Product supplied hereunder, Genentech shall refund to disclosing Connetics the results amount of any such audit to Catalentoverpayment, plus interest thereon at the auditors shall present Client with a preliminary report prime rate of findings and provide Client with up to interest as reported by Bank of America in San Francisco, California at the time of such review. If such overpayment is greater than [* * *] days of the actual amount that should have been charged to respond Connetics, then Genentech shall pay Connetics' actual costs of such review. (b) Connetics shall pay to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within Genentech [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the Genentech's fully burdened costs related to requests by Connetics to audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [or inspect Genentech's, or Genentech's third party [ * * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, in which case Client shall bear the responsibility for any such reasonable fees and expenses.MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED

Appears in 1 contract

Sources: Supply Agreement (Intermune Pharmaceuticals Inc)

Records; Audit Rights. Client (a) Seller will, and will cause its Affiliates, licensees and sublicensees to keep complete and accurate books maintain, for a period of [**] Calendar Years from the end of an applicable Calendar Year, accounts and records relating of all data reasonably required to verify Product Payments and Royalty Reports and to verify and calculate the amounts to be paid to Purchaser under this Agreement, and to verify the expenses for which the Purchase Price proceeds were used. Seller shall require its Affiliates, licensees and sublicensees conducting activities with respect to Products to report to Seller all amounts payable information required to Catalent hereunderbe provided to Purchaser pursuant to Section 2.2(a). Purchaser shall treat such information as Confidential Information of Seller. (b) During the Term and for [**] Calendar Years thereafter, sales of Products, its calculation of royalties during normal business hours and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for upon at least [* * **] years after the expiration of the year Business Days’ prior written notice to which they relateSeller, but no more frequently than [**] per Calendar Year (unless a prior audit has determined that Seller has under-reported Product Payments by more than [**] percent ([**]%) for a Calendar Year, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent which case Purchaser shall be entitled to [**]), and no more than [**] with respect to each [**] during the Royalty Period, Purchaser shall have the right to audit, or to have through an independent certified public accountant auditselected by Purchaser that is acceptable to Seller (which acceptance will not be unreasonably withheld, such books conditioned or delayed), those accounts and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientrecords of Seller and Seller’s relevant location and to such of the pertinent Records of Client Affiliates as may be reasonably necessary to verify the matters in question. Such access shall include accuracy of the right of Catalent or Royalty Reports and the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years amounts received by Purchaser (provided, however, that, prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in conducting any such audit, to sign to sign such accountant will have entered into a confidentiality agreement in form and substance reasonably acceptable satisfactory to Catalent Seller). Purchaser’s independent certified public accountant will keep confidential all information obtained during such audit and will issue a written report to prohibit Purchaser and to Seller with only: (i) the independent accounting firm from disclosing Clientactual amount of Product Net Sales made during the Calendar Year(s) in question, (ii) the resulting over- or under-payment of Purchased Product Royalty to Purchaser that occurred during the Calendar Year(s) in question; and (iii) the details of any discrepancies between the Purchased Product Royalty that was paid and the Purchased Product Royalty that should have been paid. The Seller’s financial determination of the actual amount of Purchased Product Royalty to be paid to Purchaser under this Agreement with respect to any Calendar Year will be binding and proprietary information except as contemplated by this Agreementconclusive on the Parties upon the expiration of [**] Calendar Years following the end of such Calendar Year, unless an audit of such Calendar Year has been initiated before the expiration of such [**] Calendar Year period and is ongoing, in which case the determination of Purchased Product Royalty shall be based on the results of such audit and, if applicable, the resolution of any dispute between the Parties regarding such results. Prior Either Party shall have the right to disclosing dispute the results of any audit conducted pursuant to this Section 2.3 by giving written notice to the other Party of such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to dispute within [* * **] days Business Days of Seller’s receipt of the audit report, in which case such dispute shall be resolved in accordance with Section 9.10. (c) Purchaser is solely responsible for all the expenses of the independent certified accountant, unless the independent certified public accountant’s report (or subsequent dispute resolution, if Seller disputes such report) shows any underpayment by Seller exceeding [**] percent ([**]%) of the payment owed to respond to Purchaser for any questions raised of the Calendar Years then being reviewed. If the independent certified public accountant’s report (or issues identified subsequent dispute resolution, if Seller disputes such report) shows that Seller underpaid Purchaser by more than [**] percent (the “Review Period”[**]%). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent Seller shall be responsible for the audit period are correct or incorrect and reasonable expenses incurred by Purchaser for the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, independent certified public accountant’s services for such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written reportaudit. Any fees and expenses payment owed by one Party to another as a result of the audit shall be paid by Catalent unless made within [**] Business Days of the receipt of the audit discloses report (or the final determination of dispute resolution, if a Party disputes such report), free and clear of any and all Encumbrances. In addition, any payment under this Section 2.3 shall bear interest in accordance with Section 2.5. (d) Upon written request of Purchaser, Seller shall conduct an understatement audit of Product Net Sales by Client of more than [* * *]% of its Affiliates, licensees or sublicensees necessary to confirm the aggregate amounts payable reports provided by such Persons to Catalent pursuant Seller as set forth in Section 2.3(a). Seller shall require such Persons to this Agreement during agree to allow Seller to conduct such audit period, on terms substantially similar to those provided in which case Client shall bear the responsibility for any such reasonable fees and expensesSection 2.3(a).

Appears in 1 contract

Sources: Purchase and Sale Agreement (Ophthotech Corp.)

Records; Audit Rights. Client will ILI shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the providing of Additional Testing Services hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after Oral DNA, including any records required to calculate any royalty deductions or other adjustments hereunder. Oral DNA shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm reasonably acceptable to ILI, such which shall have the right to audit the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of ILI and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and ILI shall make its records available, during normal business hours upon at least fifteen (15) days prior written notice, which shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Such audit rights shall not be exercised by Oral DNA more than once per Calendar Year. Each such examination audit shall be limited to pertinent Records books and records for any year ending not more than [* * *] years thirty-six (36) months prior to the date of such request; provided, that, Oral DNA shall not be permitted to audit the same period of time more than once. Before permitting such The independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details concerning any discrepancies and may not reveal to Oral DNA any information learned in the course of such audit other than the amount of any such discrepancies. If Oral DNA agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for Oral DNA to enforce its rights under this Agreement or if disclosure is required by Applicable Laws. In the event there was an underpayment by ILI hereunder, ILI shall promptly (but in no event later than thirty (30) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to Oral DNA of any shortfall. In the event that there was an overpayment by ILI hereunder, Oral DNA shall promptly (but in no event later than thirty (30) days after Oral DNA’s receipt of the independent auditor’s report so correctly concluding) refund to ILI the excess amount. Oral DNA shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client ILI of more than [* * *]% five percent (5%) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, ILI shall bear the responsibility reimburse Oral DNA for any all costs incurred by Oral DNA in connection with such reasonable fees examination and expensesaudit.

Appears in 1 contract

Sources: Non Exclusive License Agreement (Interleukin Genetics Inc)

Records; Audit Rights. Client will MERCK and its Affiliates and Sublicensees shall keep and maintain for two years from the date of each payment of royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including by MERCK and its Affiliates and Sublicensees of each Product, and the Cost of Goods Sold applicable to all relevant deductions) and is achievement Net Sales of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow royalties to be determined accurately. CARDIOME shall have the calculation right for a period of two (2) years after receiving any such payment to appoint at its expense an independent certified public accountant reasonably acceptable to MERCK to audit the relevant records of MERCK and verification its Affiliates and Sublicensees to verify that the amount of all payments payable to Catalent hereunder such payment was correctly determined. MERCK and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (“Records”)30) days' written notice from CARDIOME. Upon the written request and Such audit right shall not be exercised by CARDIOME more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Product in a particular period. All records made available for audit shall be entitled deemed to be Confidential Information of MERCK. The results of each audit, or to have if any, shall be binding on both Parties. In the event there was an independent accountant auditunderpayment by MERCK hereunder, such books and records. Client MERCK shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than thirty (30) days after MERCK’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to CARDIOME of Client as may be reasonably necessary to verify any shortfall. CARDIOME shall bear the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client MERCK of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *Redacted - amount] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall total royalties payable in the audited period, as determined by the accountant to be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit periodcorrect, in which case Client MERCK shall bear the responsibility reimburse CARDIOME for any all costs incurred by CARDIOME in connection with such reasonable fees and expensesaudit.

Appears in 1 contract

Sources: Collaboration and License Agreement (Cardiome Pharma Corp)

Records; Audit Rights. Client will For a period of [***] ([***]) years, sanofi-aventis shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the sale of Licensed Products hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after ImmunoGen, including any records required to calculate any royalty adjustments hereunder. Once per Calendar Year, ImmunoGen shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm of nationally recognized standing and reasonably acceptable to sanofi-aventis, such which shall have the right to examine in confidence the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of sanofi-aventis and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and sanofi-aventis shall make its records available, during normal business hours, after at least [***] ([***]) days prior written notice to sanofi-aventis, as applicable, and shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Each such examination shall be limited to pertinent Records books and records for any year ending not more than [* * ***] years ([***]) months prior to the date of such requestrequest;provided, that, ImmunoGen shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such Records books and personnelrecords, Client sanofi-aventis may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement (in form and substance reasonably acceptable to Catalent each of the Parties) as to prohibit any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The ImmunoGen independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details of concerning any discrepancies. If Such accounting firm may not reveal to ImmunoGen any information learned in the course of such audit other than the amount of any such discrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for ImmunoGen to enforce its rights under this Agreement or if disclosure is required by law. In the event there was an underpayment by sanofi-aventis hereunder, sanofi-aventis shall promptly (but in no event later than [***] ([***]) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the event that there was an overpayment by sanofi-aventis hereunder, ImmunoGen shall promptly (but in no event later than [***] ([***]) days after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) refund to sanofi-aventis the excess amount. ImmunoGen shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client sanofi-aventis of more than [* * ***] percent ([***]% %) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, sanofi-aventis shall bear the responsibility reimburse ImmunoGen for any all costs incurred by ImmunoGen in connection with such reasonable fees examination and expensesaudit.

Appears in 1 contract

Sources: License Agreement (Immunogen Inc)

Records; Audit Rights. Client will For a period of [***] ([***]) years, sanofi-aventis shall keep and maintain, and shall require its respective Affiliates and Sublicensees to keep and maintain, such accurate and complete and accurate books and records relating to all amounts payable to Catalent in connection with the sale of Licensed Products hereunder, sales of Products, its as are necessary to allow the accurate calculation of royalties and Net Sales (including all relevant deductions) and is achievement consistent with generally accepted accounting principles of the milestone events referred royalties due to in Section 4.1(D) for at least [* * *] years after ImmunoGen, including any records required to calculate any royalty adjustments hereunder. Once per Calendar Year, ImmunoGen shall have the expiration of the year right to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have engage an independent accountant auditcertified public accounting firm of nationally recognized standing and reasonably acceptable to sanofi-aventis, such which shall have the right to examine in confidence the relevant books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location records of sanofi-aventis and to such of the pertinent Records of Client its respective Affiliates and Sublicensees as may be reasonably necessary to determine and/or verify the matters in questionamount of royalty payments due hereunder. Such access examination shall include be conducted, and sanofi-aventis shall make its records available, during normal business hours, after at least [***] ([***]) days prior written notice to sanofi-aventis, as applicable, and shall take place at the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or facility(ies) where such independent accounting firm determines appropriaterecords are maintained. Each such examination shall be limited to pertinent Records books and records for any year ending not more than [* * ***] years ([***]) months prior to the date of such request, provided, that, ImmunoGen shall not be permitted to audit the same period of time more than once. Before permitting such independent accounting firm to have access to such Records books and personnelrecords, Client sanofi-aventis may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement (in form and substance reasonably acceptable to Catalent each of the Parties) as to prohibit any Confidential Information which is to be provided to such accounting firm or to which such accounting firm will have access, while conducting the audit under this paragraph. The ImmunoGen independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent each Party a written report stating whether the payments made to Catalent for the audit period royalty reports submitted and royalties paid are correct or incorrect and the specific details of concerning any discrepancies. If Such accounting firm may not reveal to ImmunoGen any information learned in the course of such audit other than the amount of any such discrepancies. ImmunoGen agrees to hold in strict confidence all information disclosed to it, except to the extent necessary for ImmunoGen to enforce its rights under this Agreement or if disclosure is required by law. In the event there was an underpayment by sanofi-aventis hereunder, sanofi-aventis shall promptly (but in no event later than [***] ([***]) days after such Party’s receipt of the independent auditor’s report so correctly concluding) make payment to ImmunoGen of any shortfall. In the event that there was an overpayment by sanofi-aventis hereunder, ImmunoGen shall promptly (but in no event later than [***] ([***]) days after ImmunoGen’s receipt of the independent auditor’s report so correctly concluding) refund to sanofi-aventis the excess amount. ImmunoGen shall bear the full cost of such audit unless such audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client sanofi-aventis of more than [* * ***] percent ([***]% %) of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit amount of royalties in any twelve (12) month period, in which case Client case, sanofi-aventis shall bear the responsibility reimburse ImmunoGen for any all costs incurred by ImmunoGen in connection with such reasonable fees examination and expensesaudit.

Appears in 1 contract

Sources: Option and License Agreement (Immunogen Inc)

Records; Audit Rights. Client During the term of this Agreement and for three (3) years thereafter (the "Audit Period"), Licensee will keep complete and accurate books records of Licensee's and records relating to all amounts any sublicensee's sales of Licensed Products and such other matters as may affect the determination of any amount payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each case, Licensor hereunder in sufficient detail to enable the calculation and verification of all payments Licensor to determine any amounts payable to Catalent hereunder Licensor under this Agreement. During the Audit Period, Licensor may engage a recognized accounting or audit firm reasonably acceptable to Licensee to act on its behalf, to audit and inspect the files, books and records of account of Licensee relating solely to the fees owed Licensor under the Agreement, upon ten (“Records”)10) days' prior written notice, during regular business hours and in such a manner to avoid unreasonable interference with normal business operations. Upon Such audit shall be solely at Licensor's expense unless it shows a shortage in the written request amount paid to Licensee of more than five percent (5%) for the period audited. Audits shall not be conducted with unreasonable frequency and not in no event shall be conducted more than once per calendar yeartwelve month period unless the immediately preceding audit showed a shortage in the amount paid to Licensee. Should any audit result in the discovery of any shortages, Catalent Licensee shall be entitled to auditpromptly pay any such shortages, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, together with access during normal business hours to appropriate space interest calculated at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior current prime rate back to the date of such requestthe incorrect payment. Before permitting such independent accounting firm to have access to such Records and personnelShould it be discovered that the Licensor was overpaid, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign then a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts correcting adjustment shall be paid to Catalent within [* * *] days after made at the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesnext scheduled Licensee payment.

Appears in 1 contract

Sources: Exclusive License Agreement (Tasker Capital Corp)

Records; Audit Rights. Client will Biogen shall, and shall cause its Affiliates and permitted Sublicensees to, keep and maintain for three (3) years from the date of each payment under Section 4.5.1(a) (Royalty Rate) complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) of each Collaboration Product by Biogen, its Affiliates and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseits permitted Sublicensees, in sufficient detail to enable allow the calculation payments owing under Section 4.5.1(a) (Royalty Rate) to be determined accurately. Intec Pharma shall have the right for a period of three (3) years after receiving any such payment to appoint, at its expense, an independent certified public accountant reasonably acceptable to Biogen, to audit the relevant records of Biogen, its Affiliates and verification its permitted Sublicensees in order to verify that the amount of all payments payable to Catalent hereunder such payment was correctly determined. Biogen, its Affiliates and its permitted Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (“Records”)30) days written notice from Intec Pharma. Upon the written request and Such audit right shall not be exercised by Intec Pharma more than once per calendar year, Catalent in any Calendar Year. All records made available for audit shall be entitled deemed to auditbe Confidential Information of Biogen. If such independent certified public accountant correctly concludes that there was an underpayment by Biogen hereunder, or to have an independent accountant audit, such books and records. Client Biogen shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than forty-five (45) days after Intec Pharma’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to Intec Pharma of Client as may be reasonably necessary to verify any shortfall. Intec Pharma shall bear the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client Biogen or its Affiliates or permitted Sublicensees of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% five percent (5%) of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client Biogen shall bear the responsibility reimburse Intec Pharma for any all costs incurred by Intec Pharma in connection with such reasonable fees and expensesaudit. NOTE: PORTIONS OF THIS EXHIBIT ARE THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST BY THE REGISTRANT TO THE SECURITIES AND EXCHANGE COMMISSION (“COMMISSION”). SUCH PORTIONS HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION AND ARE MARKED WITH A “[***]” IN PLACE OF THE REDACTED LANGUAGE.

Appears in 1 contract

Sources: Research and License Agreement (Intec Pharma Ltd.)

Records; Audit Rights. Client (a) Seller will, and will cause its Affiliates to, consistent with their respective internal financial control and reporting practices and procedures, keep and maintain, for a period of [***] from the end of an applicable [***], accounts and records of all data reasonably required to verify calculations and related payments of Scheduled Quarterly Amounts, to verify and calculate the amounts to be paid to Purchaser under this Agreement, and to verify the expenses for which the Purchase Price proceeds were used. Seller shall also cause any counterparty to any out-license or sub-license of the Seller or the Seller’s Affiliates to prepare and maintain reasonably complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred information to be used in Section 4.1(Dcalculating Scheduled Quarterly Amounts and the expenses for which the Purchase Price proceeds were used, if any. (b) During the Term and for at least [* * ***] years after the expiration of the year to which they relatethereafter, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours and upon at least [***] prior written notice to appropriate space at ClientSeller, but no more frequently than one time per [***] without cause, as determined by Purchaser in its reasonable discretion, and no more than one time with respect to each Calendar Quarter during the Payment Period, Purchaser has the right to audit, through an independent certified public accountant selected by Purchaser and acceptable to Seller (which acceptance will not be unreasonably withheld, conditioned or delayed), those accounts and records of Seller and Seller’s relevant location and to such of the pertinent Records of Client Affiliates as may be reasonably necessary to verify the matters in question. Such access shall include accuracy of the right of Catalent Quarterly Reports and the amounts received by Purchaser or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years use of Purchase Price proceeds (provided, however, that, prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in conducting any such audit, to sign to sign such accountant will have entered into a confidentiality agreement in form and substance reasonably acceptable satisfactory to Catalent Seller). Purchaser’s independent certified public accountant will keep confidential all information obtained during such audit and will issue a written report to prohibit Purchaser and to Seller with only: (i) the independent accounting firm from disclosing Client’s financial actual amount of Net Sales made during the [***] in question, (ii) the resulting over- or under-payment of Scheduled Quarterly Amounts to Purchaser that occurred during, the [***] in question; and proprietary information except as contemplated by (iii) the details of any discrepancies between the Scheduled Quarterly Amounts that were paid and the Scheduled Quarterly Amounts that should have been paid. The determination of the actual amount of Scheduled Quarterly Amounts to be paid to Purchaser under this AgreementAgreement with respect to any [***] will be binding and conclusive on the Parties upon the expiration of [***] following the end of such [***], unless an audit of such [***] has been initiated before the expiration of such [***] period and is on-going, in which case, such determination will be binding and conclusive on the Parties upon completion of such audit. Prior to disclosing Without limiting the generality of the preceding sentence, in the event that the Parties dispute the results of any such audit performed pursuant to Catalentthis Section 2.3, then the auditors Parties shall, within [***], agree upon a nationally recognized U.S. independent auditor who has no engagement with either of the Parties within the prior [***], to review the results of the audit and the calculations and data of Seller. The designated independent auditor shall present Client make a binding determination on the Parties by selecting the results of one of the Parties, without adjustment or compromise. The costs and expenses of the engagement of the independent auditor selected to resolve the dispute will be allocated in accordance with a preliminary Section 2.3(c) below. (c) Purchaser is solely responsible for all the expenses of the independent certified accountant, unless the independent certified public accountant’s report of findings and provide Client with up to shows any underpayment by Seller exceeding [* * ***] days to respond to of the payment it owed Purchaser for any questions raised or issues identified (of the “Review Period”)[***] then being reviewed. Following If the Review Periodindependent certified public accountant’s report shows that Seller underpaid by more than [***], the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent Seller is responsible for the audit period are correct or incorrect and reasonable expenses incurred by Purchaser for the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written reportindependent certified public accountant’s services. Any fees and expenses payment owed by one Party to another as a result of the audit shall be paid by Catalent unless made within [***] of the receipt of the audit discloses an understatement by Client report, free and clear of more than [* * *]% of the aggregate amounts payable to Catalent pursuant to any and all Encumbrances. In addition, any payment under this Agreement during such audit period, in which case Client Section 2.3 shall bear the responsibility for any such reasonable fees and expensesinterest in accordance with Section 2.4.

Appears in 1 contract

Sources: Purchase and Sale Agreement (Amarin Corp Plc\uk)

Records; Audit Rights. Client will DS and its Affiliates and Sublicensees shall keep and maintain for * (*) years, or such other period of time as required by Applicable Laws if longer than * (*) years, from the date of each payment of royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by DS and is achievement its Affiliates and Sublicensees of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseLicensed Product, in sufficient detail to enable allow royalties to be determined accurately. ARQULE shall have the calculation right for a period of * (*) years, or such other period of time as required by Applicable Laws if longer than * (*) years, after receiving any such payment to appoint at its expense an independent certified public accountant reasonably acceptable to DS to audit the relevant records of DS and verification its Affiliates and Sublicensees to verify that the amount of all payments payable to Catalent hereunder such payment was correctly determined. DS and its Affiliates and Sublicensees shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (“Records”)30) days written notice from ARQULE. Upon the written request and Such audit right shall not be exercised by ARQULE more than once per calendar year, Catalent in any Calendar Year or more than once with respect to sales of a particular Licensed Product in a particular period. All records made available for audit shall be entitled deemed to be Confidential Information of DS. The results of each audit, or to have if any, shall be binding on both Parties absent manifest error. In the event there was an independent accountant auditunderpayment by DS hereunder, such books and records. Client DS shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Clientpromptly (but in any event no later than * (*) days after DS’s relevant location and to such receipt of the pertinent Records report so concluding) make payment to ARQULE of Client as may be reasonably necessary to verify any shortfall. Should the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior audit lead to the date discovery of a discrepancy to DS’s detriment, then DS may credit the amount of the discrepancy without interest against any future payments due to ARQULE under Section 4.3.1. ARQULE shall bear the full cost of such request. Before permitting audit unless such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment underreporting by Client of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client DS of more than [* * percent (*]% %) of the aggregate amounts amount of royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client DS shall bear the responsibility reimburse ARQULE for any all costs incurred by ARQULE in connection with such reasonable fees and expensesaudit.

Appears in 1 contract

Sources: License, Co Development and Co Commercialization Agreement (Arqule Inc)

Records; Audit Rights. Client ‌ Section 19.01 Newco will keep complete maintain accurate records of Base Revenues received, records of its compliance with the community commitments set forth in Article XIV, and accurate books such other records, books, accounts and memoranda as may be prescribed by the FPSC. Newco will perform self-audits or third-party audits of its data security practices and procedures (for example, SOC 1/2 audits and Type 2 audits) on no less than an annual basis. Section 19.02 Newco will make such records available to the City upon request, together with copies of any rules, regulations, terms and conditions as Newco may adopt from time to time that relate to ▇▇▇▇▇’s use of the Rights-of-Way. Newco will submit a monthly statement to the City of its estimated Base Revenues for the period on which such payment is based. The acceptance of any such statement or payment will not preclude the City from asserting that the amount paid is not the amount due, or from recovering any deficit by any lawful proceeding, including interest. Section 19.03 The City may, upon reasonable written notice and within ninety (90) days after each anniversary date of this Agreement and for two (2) years following termination or expiration hereof, at the City’s expense, examine the records of Newco relating to all amounts payable to Catalent hereunder, sales of Products, its the calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) franchise payment for at least [* * *] years after the expiration of the year to which they relate, in each case, in sufficient detail to enable the calculation and verification of all payments payable to Catalent hereunder (“Records”)preceding such anniversary date. Upon the written request and not more than once per calendar year, Catalent shall Such examination will be entitled to audit, or to have an independent accountant audit, such books and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours at Newco’s office where such records are maintained. Information identifying Newco’s customers by name or their electric consumption will not be taken from Newco’s premises. Such audit will be impartial and all audit findings, whether they decrease or increase payment to appropriate space at Clientthe City, will be reported to Newco. The City’s relevant location and right to examine the records of Newco in accordance with this Section will not be conducted by any third party employed by the City whose fee, in whole or part, for conducting such audit is contingent on findings of the pertinent Records of Client as may be reasonably necessary to verify audit. In the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for event the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses reveals that an underpayment by Client or overpayment of any amounts paid pursuant to any provision franchise fees under the terms of this AgreementAgreement has occurred, such amounts shall be paid to Catalent City or Newco, respectively, will pay within [* * *] ninety (90) days after the date Client receives the auditors’ final written report. Any fees and expenses of completion of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of more than [* * *]% other the amount of the aggregate amounts payable to Catalent pursuant to this Agreement during such audit period, in which case Client shall bear the responsibility for any such reasonable fees and expensesunderpayment or overpayment.

Appears in 1 contract

Sources: Utility Franchise Agreement

Records; Audit Rights. Client will TG and its Affiliates, Sublicensees and Distributors shall keep and maintain for three (3) years from the date of each payment of royalties and/or Sublicense Royalties hereunder complete and accurate books and records relating to all amounts payable to Catalent hereunder, of gross sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) by TG and is achievement its Affiliates, Sublicensees and Distributors of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caseProduct, in sufficient detail to enable allow royalties and/or Sublicense Royalties to be accurately determined. LICENSOR shall have the calculation and verification right for a period of all payments payable three (3) years after receiving any such royalty payment to Catalent hereunder (“Records”). Upon the written request and not more than once per calendar year, Catalent shall be entitled to audit, or to have appoint at its expense an independent certified public accountant auditreasonably acceptable to TG to audit the relevant records of TG and its Affiliates, such books Sublicensees and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location and to such of the pertinent Records of Client as may be reasonably necessary Distributors to verify that the matters in question. Such access amount of each such payment was correctly determined; provided, that, (a) if requested by TG, LICENSOR shall include the right of Catalent or cause the independent accounting firm certified public accountant to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign enter into a confidentiality agreement reasonably acceptable to Catalent TG and (b) such independent certified public accountant may only disclose to prohibit the independent accounting firm from disclosing Client’s financial and proprietary information except as contemplated by this Agreement. Prior to disclosing the results of any such audit to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating LICENSOR whether the payments made to Catalent for the audit period royalties and/or Sublicense Royalties paid are correct or incorrect and the details of with respect to any discrepancies. If TG and its Affiliates, Sublicensees and Distributors shall each make its records available for audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon thirty (30) days written notice from LICENSOR. Such audit right shall not be exercised by LICENSOR more than once in any Calendar Year or more than once with respect to sales of a particular Product in a particular period. All records made available for audit shall be deemed to be Confidential Information of TG. The results of each audit, if any, shall be binding on both Parties absent manifest error. In the event there was an underpayment of royalties by TG hereunder, TG shall promptly (but in any event no later than thirty (30) days after TG’s receipt of the report so concluding) make payment to LICENSOR of any shortfall. LICENSOR shall bear the full cost of such audit unless such audit discloses an underpayment by Client TG of any amounts paid pursuant to any provision of this Agreement, such amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses of the audit shall be paid by Catalent unless the audit discloses an understatement by Client of five percent (5%) or more than [* * *]% of the aggregate amounts amount of royalties and/or Sublicense Royalties payable to Catalent pursuant to this Agreement during such audit periodin any Calendar Year, in which case Client TG shall bear the responsibility reimburse LICENSOR for any all costs incurred by LICENSOR in connection with such reasonable fees and expensesaudit.

Appears in 1 contract

Sources: Exclusive License Agreement (Manhattan Pharmaceuticals Inc)

Records; Audit Rights. Client will keep Alvogen shall, and shall cause other Selling Persons to, maintain complete and accurate books and records relating to all amounts payable to Catalent hereunder, sales of Products, its calculation of royalties and Net Sales (including all relevant deductions) and is achievement of the milestone events referred to in Section 4.1(D) for at least [* * *] years after the expiration of the year to which they relate, in each caserecords, in sufficient detail to enable confirm the calculation accuracy of payments and verification of all costs with respect to payments payable to Catalent hereunder under this Agreement (the Product Financial Records”). Upon Alvogen shall retain all Product Financial Records for a period of at least three (3) years or for such longer period to the extent required by Applicable Law. During such period, upon the written request of Pfenex, the Product Financial Records shall be subject to inspection and not audit by and at the expense of Pfenex no more than once per calendar yeartwo times in any Annual Period, Catalent unless for cause. Such audits shall be entitled to audit, or to have an independent accountant audit, such books occur upon reasonable notice and records. Client shall provide Catalent or such auditors, as applicable, with access during normal business hours to appropriate space at Client’s relevant location by an independent auditor selected by Pfenex and to such of the pertinent Records of Client as may be reasonably necessary to verify the matters in question. Such access shall include the right of Catalent or the independent accounting firm to interview Catalent’s personnel as Catalent or such independent accounting firm determines appropriate. Each such examination shall be limited to pertinent Records for any year ending not more than [* * *] years prior to the date of such request. Before permitting such independent accounting firm to have access to such Records and personnel, Client may require such independent accounting firm and its personnel involved in such audit, to sign to sign a confidentiality agreement reasonably acceptable to Catalent Alvogen. Pfenex shall treat all information received or subject to prohibit review under this Section 4.4 as Confidential Information of Alvogen in accordance with the provisions of Article VIII. Pfenex shall cause its independent accounting firm from disclosing Client’s financial auditor to enter into a confidentiality agreement, in form and proprietary substance reasonably acceptable to Alvogen, to maintain such records and information of Alvogen in confidence in accordance with Article VIII and not use such records or information except as contemplated to the extent permitted by this Agreement, including any enforcement of the provisions hereof. Prior to disclosing the results of If any such audit reveals that Alvogen has failed to Catalent, the auditors shall present Client with a preliminary report of findings and provide Client with up to [* * *] days to respond to accurately make any questions raised or issues identified (the “Review Period”). Following the Review Period, the auditors will prepare and provide to Client and Catalent a written report stating whether the payments made to Catalent for the audit period are correct or incorrect and the details of any discrepancies. If an audit discloses an underpayment by Client of any amounts paid pursuant to any provision of payment required under this Agreement, then Alvogen shall promptly pay to Pfenex any underpaid amounts due under this Agreement, together with interest calculated as set forth in Section 4.3, or Pfenex shall promptly pay to Alvogen any overpaid amounts paid under this Agreement, as the case may be. If any such audit reveals an underpayment of amounts shall be paid to Catalent within [* * *] days after the date Client receives the auditors’ final written report. Any fees and expenses due under this Agreement greater than five percent (5%) of the audit amounts actually due for any Annual Period, then Alvogen shall be paid by Catalent unless pay the audit discloses an understatement by Client of more than reasonable out-of-pocket costs incurred in conducting such audit. [* * ***]% of the aggregate amounts payable to Catalent pursuant to Certain confidential information contained in this Agreement during such audit perioddocument, in which case Client shall bear the responsibility for any such reasonable fees marked by brackets, has been omitted because it is both (i) not material and expenses(ii) would be competitively harmful if publicly disclosed.

Appears in 1 contract

Sources: Development and License Agreement (Pfenex Inc.)