Option Notice. On a Licensed Product-by-Licensed Product basis, at least [*]prior to the anticipated date of Initiation of the first Pivotal Study for such Licensed Product (as such date of Initiation is set forth in the draft Cost Share Development Plan provided pursuant to this Section 6.2 or otherwise determined by the JSC, each an “Anticipated Pivotal Study Date”), Astellas shall provide to Sutro, to the extent not already in Sutro’s possession (a) all material clinical data to be included in the clinical study report (CSR) for all Clinical Trials conducted prior to initiation of the first Pivotal Study in the form then available, (b) all material preclinical data as well as all material data related to Development work conducted on such Licensed Product, (c) documentation of all substantive interactions with Regulatory Authorities as well as Regulatory Materials (e.g. the IND) for such Licensed Product, and (d) a U.S. development plan describing the overall plan for the Development of Licensed Compounds and Licensed Products in the United States, including all Clinical Trials intended to support Regulatory Approval from the FDA for such Licensed Product that would be Initiated following Sutro’s exercise of a Cost Share Option (if it were to do so), and related budget detailing the fully burdened cost for conducting such Clinical Trials and other Development activities (including for (i) Global Trials and (ii) global activities or activities outside the United States (other than Global Trials) that are reasonably allocable to Development in the United States), including a regulatory strategy for obtaining marketing approval from the FDA for the Licensed Product (each a “Cost Share Development Plan” and each corresponding budget, the “Cost Share Development Budget”). The Parties shall in good faith discuss such initial Cost Share Development Plan and Cost Share Development Budget through the JSC and the Parties shall discuss and, prior to the Option Effective Date, agree in writing (and outside the purview of JSC discussions) upon [*]. If the Parties cannot reach agreement on such FTE Rates, then the dispute shall be resolved in accordance with Section 15.4(c). Sutro may, in its sole discretion, exercise the Cost Share Option and, in connection with the exercise of such Cost Share Option, exercise the CoPro Option, for such Licensed Product, provided that in each case it must do so by notifying Astellas in writing of such option exercise at least [*]before the Anticipated Pivotal Study Date for the applicable Licensed Product (the date of such notice the “Option Effective Date”). For clarity, (A) the CoPro Option for a Licensed Product cannot be exercised unless the Cost Share Option has been exercised for such Licensed Product and (B) if Sutro has not exercised its Cost Share Option by written notice [*]before the Anticipated Pivotal Study Date for a Licensed Product, such Cost Share Option (and the corresponding CoPro Option) shall terminate.
Appears in 1 contract
Sources: License and Collaboration Agreement (Sutro Biopharma, Inc.)
Option Notice. On a Licensed Product-by-Licensed Product basisParent shall not assume any Company Options (as defined in Section 2.05) or any other options, at least [*]prior warrants or other rights to acquire Company Stock. Promptly after the anticipated date of Initiation this Agreement, the Company shall send a notice (the “Option Notice”) to all holders of Company Options, in accordance with the first Pivotal Study for such Licensed Product applicable Stock Plans (as such date of Initiation is set forth defined in the draft Cost Share Development Plan provided pursuant to this Section 6.2 or otherwise determined by the JSC, each an “Anticipated Pivotal Study Date”3.04(b)), Astellas which notice shall provide to Sutro, to the extent not already in Sutro’s possession notify such holders (a) all material clinical data to be included in the clinical study report (CSR) for all Clinical Trials conducted prior to initiation of the first Pivotal Study in the form then availableexecution and delivery of this Agreement, (b) all material preclinical data as well as all material data related to Development work conducted on such Licensed Productthat Parent and the Surviving Corporation shall not be assuming or substituting for any Company Options following the Effective Time, (c) documentation that all unvested Company Options shall become vested and immediately exercisable upon receipt of the Stockholder Approval (as defined in Section 3.16), (d) that all substantive interactions with Regulatory Authorities Company Options that are not exercised on or before the Option Exercise Date shall be cancelled as well as Regulatory Materials (e.g. the IND) for of such Licensed Productdate, and (d) a U.S. development plan describing the overall plan for the Development of Licensed Compounds and Licensed Products in the United States, including all Clinical Trials intended to support Regulatory Approval from the FDA for such Licensed Product that would be Initiated following Sutro’s exercise of a Cost Share Option (if it were to do so), and related budget detailing the fully burdened cost for conducting such Clinical Trials and other Development activities (including for (i) Global Trials and (ii) global activities or activities outside the United States (other than Global Trialse) that any holder of Company Options which are reasonably allocable to Development in the United States), including a regulatory strategy for obtaining marketing approval from the FDA for the Licensed Product (each a “Cost Share Development Plan” and each corresponding budget, the “Cost Share Development Budget”). The Parties shall in good faith discuss such initial Cost Share Development Plan and Cost Share Development Budget through the JSC and the Parties shall discuss and, not exercised prior to the Option Effective Date, agree in writing (Exercise Date and outside the purview of JSC discussions) upon [*]. If the Parties cannot reach agreement on such FTE Rates, then the dispute shall be resolved are cancelled in accordance with the terms of the Option Notice shall be entitled to the payment provided in Section 15.4(c2.05. It is agreed and understood that for all purposes of this Agreement the parties will not treat as exercised (and will instead treat as outstanding unexercised Company Options) any Company Option that the holder has purported to exercise, unless prior to the Option Exercise Date (i) the holder of the Company Option has fully complied with the conditions to such exercise and the holder’s obligations with respect to such exercise as set out in the applicable Stock Plan, if applicable, the Option Notice and the applicable Company Option documentation (including without limitation by paying in full the applicable purchase price for the shares subject to that Company Option and any applicable amounts required to be paid in respect of withholding obligations under the applicable Stock Plan and applicable law). Sutro may, (ii) the Company has issued a valid certificate for the shares of Company Stock purchased upon exercise of that Company Option, as determined by Parent in its sole reasonable discretion, exercise and (iii) such shares are reflected as being outstanding on the Cost Share Closing Certificate. The Option andNotice shall include specific procedures, in connection with mutually acceptable to Parent and the Company, to facilitate the exercise of such Cost Share Option, exercise Company Options as of the CoPro Option, for such Licensed Product, provided that in each case it must do so by notifying Astellas in writing of such option exercise at least [*]before the Anticipated Pivotal Study Date for the applicable Licensed Product (the date of such notice the “Option Effective Exercise Date”). For clarity, (A) the CoPro Option for a Licensed Product cannot be exercised unless the Cost Share Option has been exercised for such Licensed Product and (B) if Sutro has not exercised its Cost Share Option by written notice [*]before the Anticipated Pivotal Study Date for a Licensed Product, such Cost Share Option (and the corresponding CoPro Option) shall terminate.
Appears in 1 contract
Sources: Merger Agreement (Cytyc Corp)
Option Notice. On a Licensed Product-by-Licensed Product basisParent shall not assume any Company Options issued under the Company’s 1997 Stock Plan (the “Company Option Plan”), at least [*]or any other options, warrants or other rights to acquire Company Common Stock or Company Preferred Stock. No later than eighteen (18) days prior to the anticipated date Closing Date, the Company shall send a notice (the “Option Notice”) to all holders of Initiation Company Options, pursuant to Section 12(c) of the first Pivotal Study Company Option Plan, which notice shall notify such holders that (A) Parent and the Surviving Corporation shall not be assuming or substituting for such Licensed Product any Company Options following the Effective Time, (as such date of Initiation is set forth in the draft Cost Share Development Plan provided pursuant to this Section 6.2 or otherwise determined by the JSC, each an “Anticipated Pivotal Study Date”), Astellas shall provide to Sutro, to the extent not already in Sutro’s possession (aB) all material clinical data to be included in the clinical study report (CSR) for all Clinical Trials conducted prior to initiation of the first Pivotal Study in the form then availableunvested Company Options shall become vested and immediately exercisable, (bC) all material preclinical data as well as all material data related to Development work conducted unexercised Company Options shall terminate on such Licensed Product, the fifteenth (c15th) documentation of all substantive interactions with Regulatory Authorities as well as Regulatory Materials (e.g. the IND) for such Licensed Product, and (d) a U.S. development plan describing the overall plan for the Development of Licensed Compounds and Licensed Products in the United States, including all Clinical Trials intended to support Regulatory Approval from the FDA for such Licensed Product that would be Initiated day following Sutro’s exercise of a Cost Share Option (if it were to do so), and related budget detailing the fully burdened cost for conducting such Clinical Trials and other Development activities (including for (i) Global Trials and (ii) global activities or activities outside the United States (other than Global Trials) that are reasonably allocable to Development in the United States), including a regulatory strategy for obtaining marketing approval from the FDA for the Licensed Product (each a “Cost Share Development Plan” and each corresponding budget, the “Cost Share Development Budget”). The Parties shall in good faith discuss such initial Cost Share Development Plan and Cost Share Development Budget through the JSC and the Parties shall discuss and, prior to the Option Effective Date, agree in writing (and outside the purview of JSC discussions) upon [*]. If the Parties cannot reach agreement on such FTE Rates, then the dispute shall be resolved in accordance with Section 15.4(c). Sutro may, in its sole discretion, exercise the Cost Share Option and, in connection with the exercise of such Cost Share Option, exercise the CoPro Option, for such Licensed Product, provided that in each case it must do so by notifying Astellas in writing of such option exercise at least [*]before the Anticipated Pivotal Study Date for the applicable Licensed Product (the date of such notice Option Notice, with such fifteen day period being referred to herein as the “Option Termination Period”, and (D) that any holder of Company Options that are not exercised prior to the end of the Option Termination Period and are terminated in accordance with the terms of the Option Notice shall be entitled to payment as provided in clause (ii) below. It is agreed and understood that for all purposes of this Agreement the parties will not treat as exercised (and will instead treat as outstanding unexercised Company Options) any Company Option that the holder has purported to exercise unless prior to the Effective Date”Time (x) the holder of the Company Option has fully complied with the conditions to such exercise and the holder’s obligations with respect to such exercise as set out in the Company Option Plan, if applicable, and the applicable Company Option documentation (including without limitation by paying in full the applicable purchase price for the shares subject to that Company Option and any applicable amounts required to be paid in respect of withholding obligations under the Company Option Plan and applicable law). For clarity, (Ay) the CoPro Option Company has issued a valid certificate for a Licensed Product cannot be exercised unless the Cost Share Option has been exercised for such Licensed Product shares of Company Common Stock purchased upon exercise of that Company Option, as determined by Parent in its reasonable discretion, and (Bz) if Sutro has not exercised its Cost Share such shares are reflected as being outstanding on the Capitalization and Closing Payment Certificate. The Option by written notice [*]before the Anticipated Pivotal Study Date for a Licensed ProductNotice shall include specific procedures, such Cost Share Option (mutually acceptable to Parent and the corresponding CoPro Option) shall terminateCompany, to facilitate the exercise of Company Options as of the Effective Time.
Appears in 1 contract
Sources: Merger Agreement (Cytyc Corp)