Minimum Sales. a) If the first Regulatory Approval of the Collaboration Product in the United States does not significantly differ from the TPP, Pharmacia guarantees that Pharmacia and its Sublicensees will achieve Net Sales of [*] per calendar year during the second through tenth full calendar years after the First Commercial Sale; provided that if this Agreement shall terminate or expire prior to the end of any such full calendar year, Pharmacia guarantees, with respect to such less than full calendar year, that Pharmacia and its Sublicensees will achieve Net Sales of such pro rata portion of [*] as corresponds to the percentage of such calendar year comprised by the period therein ending upon the effective date of such termination or expiration. Beginning with the third full calendar year after the First Commercial Sale, such minimum Net Sales amount shall be adjusted annually based on the changes in the Producer Price Index for Pharmaceutical Preparations. Notwithstanding the foregoing, such minimum Net Sales obligations will not be applicable where (i) Nastech fails to supply sufficient quantities of Collaboration Product in accordance with the Supply Agreement (unless such failure is caused primarily by any act or omission of Pharmacia or its Sublicensees in breach hereof or of the Supply Agreement) or (ii) the Collaboration Product is withdrawn from the market because continued sale of such Collaboration Product would be in violation of applicable Law or Pharmacia determines that the continued sale of such Collaboration Product would be unethical. In the event Pharmacia and its Sublicensees fail to achieve the applicable minimum Net Sales, Pharmacia shall (x) pay royalties to Nastech as if such minimum Net Sales had been achieved, and (y) grant rights to Nastech to permit Nastech’s sales representatives to detail Collaboration Product, at Nastech’s cost, in the US, Japan and major EU markets, to the extent permitted under applicable Laws and in accordance with the Global Commercialization Plan. b) In the event of a dispute between the Parties as to whether the Collaboration Product conforms to the TPP in accordance with Sections 5.7(b) or 9.3(a), the matter shall be submitted for decision to a neutral Third Party of sufficient knowledge and experience with the disputed subject matter who shall have been approved by Nastech and Pharmacia. In determining the conformity of the Collaboration Product to the TPP, the dispositive issue shall be whether the Collaboration Product exhibits any deviance or deviances from the TPP that is or are likely to have a material adverse impact upon the Collaboration Product’s marketability. The decision of such neutral shall be in writing, and shall be binding upon the Parties.
Appears in 1 contract
Sources: Collaboration and License Agreement (Nastech Pharmaceutical Co Inc)
Minimum Sales. (a) If Exhibit C hereto sets forth certain targets for the first Regulatory Approval agreed minimum unit sales of the Collaboration Licensed Product in the United States does not significantly differ from the TPP, Pharmacia guarantees that Pharmacia and its Sublicensees will achieve Net Sales Territory (“Minimum Sales”) for a period of [*]. It is acknowledged by the Parties that all Approvals pursuant to the MRP will not be obtained within [*] per calendar following the Launch Date in the first country of the Territory through no fault of Licensee and the Parties have agreed to vary the Minimum Sales accordingly.
(b) If Licensee fails to achieve the Minimum Sales in a given year during then Licensee shall pay to Cellegy the second through tenth full calendar years after Royalties that would have been due to Cellegy had the First Commercial Sale; provided Minimum Sales for that if this Agreement shall terminate or expire prior particular year been achieved, such shortfall in the Royalties to be paid within sixty (60) days following the end of the relevant year. For the avoidance of doubt this shall be Cellegy’s sole remedy for Licensee’s failure to achieve the Minimum Sales in any such full calendar year, Pharmacia guaranteesexcept as provided in paragraph (d) below. However in the event Licensee fails to pay the relevant shortfall within sixty (60) days following the end of the relevant year this shall constitute material breach and Cellegy shall be entitled to terminate this Agreement in accordance with Section 16.2(c).
(c) The Minimum Sales amounts set forth on Exhibit C are subject to review and revision as described in Section 11.4 below.
(d) At any time commencing with “Year 3” Minimum Sales as set forth on Exhibit C, with respect if Licensee fails to achieve, in any particular country, the annual Minimum Sales amounts for such less than full calendar year, that Pharmacia and its Sublicensees will achieve Net Sales of such pro rata portion of country as set forth on Exhibit C for any [*] as corresponds consecutive years, and if the Relevant Regulatory Authority for such country has not required any substantial and significant changes to the percentage Current SmPC that can reasonably be expected to materially and adversely affect Licensee’s competitive position and ability to market and sell the Licensed Product in such country, then if the Steering Committee cannot agree (without the occurrence of a deadlock) on mutually satisfactory modifications to the Minimum Sales amounts for such calendar year comprised by country, then Cellegy may, at its option, make the period therein ending upon exclusive license granted pursuant to Sections 2.1 and 2.2 herein a nonexclusive license for the effective date remainder of the term of this Agreement as it relates to such termination or expiration. Beginning country in the Territory, except for the right to use Cellegy Marks granted to Licensee hereunder, which shall continue to be exclusive for Cellegy’s M▇▇▇ actually being used in connection with the third full calendar year after Licensed Product, and without limiting the First Commercial Saleabove may import, such minimum Net Sales amount shall be adjusted annually based on store, Develop, have Developed, promote, market, distribute, offer for sale, and sell the changes in the Producer Price Index for Pharmaceutical Preparations. Notwithstanding the foregoing, such minimum Net Sales obligations will not be applicable where (i) Nastech fails to supply sufficient quantities of Collaboration Licensed Product in accordance with the Supply Agreement (unless such failure is caused primarily by any act country on its own or omission of Pharmacia or its Sublicensees in breach hereof or of the Supply Agreement) or (ii) the Collaboration Product is withdrawn from the market because continued sale of such Collaboration Product would be in violation of applicable Law or Pharmacia determines that the continued sale of such Collaboration Product would be unethical. In the event Pharmacia and its Sublicensees fail to achieve the applicable minimum Net Sales, Pharmacia shall (x) pay royalties to Nastech as if such minimum Net Sales had been achieved, and (y) grant rights to Nastech to permit Nastech’s sales representatives to detail Collaboration Product, at Nastech’s cost, in the US, Japan and major EU markets, to the extent permitted under applicable Laws and in accordance with the Global Commercialization Plan.
b) In the event of through a dispute between the Parties as to whether the Collaboration Product conforms to the TPP in accordance with Sections 5.7(b) or 9.3(a), the matter shall be submitted for decision to a neutral Third Party of sufficient knowledge and experience with the disputed subject matter who shall have been approved by Nastech and Pharmacia. In determining the conformity of the Collaboration Product to the TPP, the dispositive issue shall be whether the Collaboration Product exhibits any deviance or deviances from the TPP that is or are likely to have a material adverse impact upon the Collaboration Product’s marketability. The decision of such neutral shall be in writing, and shall be binding upon the Partieslicensee.
Appears in 1 contract
Sources: Exclusive License Agreement (Cellegy Pharmaceuticals Inc)
Minimum Sales. (a) If the first Regulatory Approval Licensee shall achieve agreed annual minimum unit sales of the Collaboration Licensed Product in the United States does not significantly differ from the TPP, Pharmacia guarantees that Pharmacia and its Sublicensees will achieve Net Sales of Territory representing [*] per calendar year during the second through tenth full calendar years after the First Commercial Sale; provided that if this Agreement shall terminate or expire prior to the end of any such full calendar (“Minimum Sales”). The first year, Pharmacia guarantees, with respect to such less than full calendar year, that Pharmacia and its Sublicensees will achieve Net ’s agreed annual Minimum Sales of such pro rata portion of [*] as corresponds to the percentage of such calendar year comprised by the period therein ending upon the effective date of such termination or expiration. Beginning with the third full calendar year after the First Commercial Sale, such minimum Net Sales amount shall be adjusted annually based on the changes figure is set forth in the Producer Price Index for Pharmaceutical Preparations. Notwithstanding relevant Marketing Plan in the foregoing, such minimum Net Sales obligations will not be applicable where (i) Nastech fails form delivered by Licensee to supply sufficient quantities of Collaboration Product in accordance with the Supply Agreement (unless such failure is caused primarily by any act or omission of Pharmacia or its Sublicensees in breach hereof or Cellegy as of the Supply Agreement) or (ii) the Collaboration Product is withdrawn from the market because continued sale of such Collaboration Product would be in violation of applicable Law or Pharmacia determines that the continued sale of such Collaboration Product would be unethicalEffective Date. In the event Pharmacia and its Sublicensees fail that all Approvals pursuant to the MRP are not obtained within [*] following the Launch Date in the first country of the Territory the Parties shall meet to discuss the Minimum Sales accordingly.
(b) If Licensee fails to achieve the applicable minimum Net SalesMinimum Sales in a given year then Licensee shall pay to Cellegy [*], Pharmacia such amount to be paid within [*] following the end of the relevant year. For the avoidance of doubt this shall be Cellegy’s sole remedy for Licensee’s failure to achieve the Minimum Sales in any year, except as provided in paragraph (xd) pay royalties to Nastech as if such minimum Net Sales had been achieved, and (y) grant rights to Nastech to permit Nastech’s sales representatives to detail Collaboration Product, at Nastech’s costbelow. However, in the US, Japan event Licensee fails to pay the amount described in the first sentence of this subparagraph within sixty (60) days following the end of the relevant year this shall constitute material breach and major EU markets, Cellegy shall be entitled to the extent permitted under applicable Laws and terminate this Agreement in accordance with the Global Commercialization PlanSection 16.2(c).
b(c) In The Minimum Sales amounts are subject to review and revision as described in Section 11.4 below.
(d) At any time commencing with “Year 3”, if Licensee fails to achieve the event minimum sales set out in the Marketing Plan for any particular country in the Territory, for any [*] consecutive years, then if the Steering Committee cannot agree (without the occurrence of a dispute between the Parties as to whether the Collaboration Product conforms deadlock) on mutually satisfactory modifications to the TPP in accordance with Sections 5.7(b) or 9.3(a), the matter shall be submitted minimum sales amounts for decision such [*] designates portions of this document that have been omitted pursuant to a neutral request for confidential treatment filed seperately with the Commission country, then Cellegy may, at its option, make the exclusive license granted pursuant to Sections 2.1 and 2.2 herein a nonexclusive license for the remainder of the term of this Agreement as it relates to such country in the Territory, except for the right to use Cellegy Marks granted to Licensee hereunder, which shall continue to be exclusive for Cellegy’s M▇▇▇ actually being used in connection with the Licensed Product, and without limiting the above may import, store, Develop, have Developed, promote, market, distribute, offer for sale, and sell the Licensed Product in such country on its own or through a Third Party of sufficient knowledge and experience with the disputed subject matter who shall have been approved by Nastech and Pharmacia. In determining the conformity of the Collaboration Product to the TPP, the dispositive issue shall be whether the Collaboration Product exhibits any deviance or deviances from the TPP that is or are likely to have a material adverse impact upon the Collaboration Product’s marketability. The decision of such neutral shall be in writing, and shall be binding upon the Partieslicensee.
Appears in 1 contract
Sources: Exclusive License and Distribution Agreement (Cellegy Pharmaceuticals Inc)
Minimum Sales. (a) If Exhibit C hereto sets forth certain targets for the first Regulatory Approval agreed minimum unit sales of the Collaboration Licensed Product in the United States does not significantly differ from the TPP, Pharmacia guarantees that Pharmacia and its Sublicensees will achieve Net Sales Territory (“Minimum Sales”) for a period of [*] per calendar year during the second through tenth full calendar years after the First Commercial Sale; provided that if this Agreement shall terminate or expire prior to the end of any such full calendar year, Pharmacia guarantees, with respect to such less than full calendar year, that Pharmacia and its Sublicensees will achieve Net Sales of such pro rata portion of [*] as corresponds to the percentage of such calendar year comprised by the period therein ending upon the effective date of such termination or expiration. Beginning with the third full calendar year after the First Commercial Sale, such minimum Net Sales amount shall be adjusted annually based on the changes in the Producer Price Index for Pharmaceutical Preparations. Notwithstanding the foregoing, such minimum Net Sales obligations will not be applicable where (i) Nastech fails to supply sufficient quantities of Collaboration Product in accordance with the Supply Agreement (unless such failure is caused primarily by any act or omission of Pharmacia or its Sublicensees in breach hereof or of the Supply Agreement) or (ii) the Collaboration Product is withdrawn from the market because continued sale of such Collaboration Product would be in violation of applicable Law or Pharmacia determines that the continued sale of such Collaboration Product would be unethical]. In the event Pharmacia and its Sublicensees fail that all Approvals pursuant to the MRP are not obtained within [*] following the Launch Date in the first country of the Territory the Parties shall meet to discuss the Minimum Sales accordingly.
(b) If Licensee fails to achieve the applicable minimum Net Sales, Pharmacia Minimum Sales in a given year then Licensee shall (x) pay royalties to Nastech as if such minimum Net Cellegy the Royalties that would have been due to Cellegy had the Minimum Sales had for that particular year been achieved, and (y) grant rights to Nastech to permit Nastech’s sales representatives to detail Collaboration Product, at Nastech’s cost, such shortfall in the USRoyalties to be paid within sixty (60) days following the end of the relevant year. For the avoidance of doubt this shall be Cellegy’s sole remedy for Licensee’s failure to achieve the Minimum Sales in any year, Japan except as provided in paragraph (d) below. However in the event Licensee fails to pay the relevant shortfall within sixty (60) days following the end of the relevant year this shall constitute material breach and major EU markets, Cellegy shall be entitled to the extent permitted under applicable Laws and terminate this Agreement in accordance with the Global Commercialization PlanSection 16.2(c).
b(c) In The Minimum Sales amounts set forth on Exhibit C are subject to review and revision as described in Section 11.4 below.
(d) At any time commencing with “Year 3” Minimum Sales as set forth on Exhibit C, if Licensee fails to achieve, in any particular country, the event annual Minimum Sales amounts for such country as set forth on Exhibit C for any [*] consecutive years, and if the Relevant Regulatory Authority for such country has not required any substantial and significant changes to the Current SmPC that can reasonably be expected to materially and adversely affect Licensee’s competitive position and ability to market and sell the Licensed Product in such country, then if the Steering Committee cannot agree (without the occurrence of a dispute between the Parties as to whether the Collaboration Product conforms deadlock) on mutually satisfactory modifications to the TPP Minimum Sales amounts for such country, then Cellegy may, at its option, make the exclusive license granted pursuant to Sections 2.1 and 2.2 herein a nonexclusive license for the remainder of the term of this Agreement as it relates to such country in accordance the Territory, except for the right to use Cellegy Marks granted to Licensee hereunder, which shall continue to be exclusive for Cellegy’s ▇▇▇▇ actually being used in connection with Sections 5.7(b) the Licensed Product, and without limiting the above may import, store, Develop, have Developed, promote, market, distribute, offer for sale, and sell the Licensed Product in such country on its own or 9.3(a), the matter shall be submitted for decision to through a neutral Third Party of sufficient knowledge and experience with the disputed subject matter who shall have been approved by Nastech and Pharmacia. In determining the conformity of the Collaboration Product to the TPP, the dispositive issue shall be whether the Collaboration Product exhibits any deviance or deviances from the TPP that is or are likely to have a material adverse impact upon the Collaboration Product’s marketability. The decision of such neutral shall be in writing, and shall be binding upon the Partieslicensee.
Appears in 1 contract
Sources: Exclusive License Agreement (Cellegy Pharmaceuticals Inc)