VRTX » Topics » RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.

These excerpts taken from the VRTX 10-K filed Feb 17, 2009.

RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.

        We have manufacturing, collaborative and clinical trial relationships, and we and our collaborators are seeking approval for our drug candidates, outside the United States. In addition, we expect that if telaprevir is approved for commercial sale, a significant portion of our commercial supply chain, including sourcing of raw materials and manufacturing, will be located in Asia and the European Union. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated with conducting operations in foreign countries include:

    differing regulatory requirements for drug approvals in foreign countries;

    unexpected changes in tariffs, trade barriers and regulatory requirements;

    economic weakness, including inflation, or political instability in particular foreign economies and markets;

    compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

    foreign taxes, including withholding of payroll taxes;

    foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating a subsidiary in another country;

    workforce uncertainty in countries where labor unrest is more common than in the United States;

    production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

    business interruptions resulting from geo-political actions, including war and terrorism.

        These and other risks associated with our international operations could materially adversely affect our business.

RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.



        We have manufacturing, collaborative and clinical trial relationships, and we and our collaborators are seeking approval for our drug
candidates, outside the United States. In addition, we expect that if telaprevir is approved for commercial sale, a significant portion of our commercial supply chain, including sourcing of raw
materials and manufacturing, will be located in Asia and the European Union. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated
with conducting operations in foreign countries include:





    differing regulatory requirements for drug approvals in foreign countries;


    unexpected changes in tariffs, trade barriers and regulatory requirements;


    economic weakness, including inflation, or political instability in particular foreign economies and markets;


    compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;


    foreign taxes, including withholding of payroll taxes;


    foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other
    obligations incident to doing business or operating a subsidiary in another country;



    workforce uncertainty in countries where labor unrest is more common than in the United States;


    production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and


    business interruptions resulting from geo-political actions, including war and terrorism.



        These
and other risks associated with our international operations could materially adversely affect our business.



These excerpts taken from the VRTX 10-K filed Feb 11, 2008.

RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.

        We have manufacturing, collaborative and clinical trial relationships, and we and our collaborators are seeking approval for our drug candidates, outside the United States. In addition, we expect that if telaprevir is approved for commercial sale, a significant portion of our commercial supply chain, including sourcing of raw materials and manufacturing, will be located in China, Japan and European Union. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated with conducting operations in foreign countries include:

    differing regulatory requirements for drug approvals in foreign countries;

40


    unexpected changes in tariffs, trade barriers and regulatory requirements;

    economic weakness, including inflation, or political instability in particular foreign economies and markets;

    compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

    foreign taxes, including withholding of payroll taxes;

    foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating a subsidiary in another country;

    workforce uncertainty in countries where labor unrest is more common than in the United States;

    production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

    business interruptions resulting from geo-political actions, including war and terrorism.

        These and other risks associated with our international operations could materially adversely affect our business.

RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.




        We have manufacturing, collaborative and clinical trial relationships, and we and our collaborators are seeking approval for our drug candidates, outside the
United States. In addition, we expect that if telaprevir is approved for commercial sale, a significant portion of our commercial supply chain, including sourcing of raw materials and manufacturing,
will be located in China, Japan and European Union. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated with conducting
operations in foreign countries include:





    differing
    regulatory requirements for drug approvals in foreign countries;


40












    unexpected
    changes in tariffs, trade barriers and regulatory requirements;


    economic
    weakness, including inflation, or political instability in particular foreign economies and markets;


    compliance
    with tax, employment, immigration and labor laws for employees living or traveling abroad;


    foreign
    taxes, including withholding of payroll taxes;


    foreign
    currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating a
    subsidiary in another country;


    workforce
    uncertainty in countries where labor unrest is more common than in the United States;


    production
    shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and


    business
    interruptions resulting from geo-political actions, including war and terrorism.





        These
and other risks associated with our international operations could materially adversely affect our business.



This excerpt taken from the VRTX 10-K filed Mar 1, 2007.

RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS.

We have manufacturing, collaborative and clinical trial relationships, and we and our collaborators are seeking approval for our drug candidates, outside the United States. In addition, we expect that if telaprevir is approved for commercial sale, a significant portion of our commercial supply chain, including sourcing of raw materials and manufacturing, will be located in the Far East and European Union. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries. Risks associated with conducting operations in foreign countries include:

·       differing regulatory requirements for drug approvals in foreign countries;

·       unexpected changes in tariffs, trade barriers and regulatory requirements;

·       economic weakness, including inflation, or political instability in particular foreign economies and markets;

·       compliance with tax, employment, immigration and labor laws for employees living or travelling abroad;

41




·       foreign taxes, including withholding of payroll taxes;

·       foreign currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to doing business or operating a subsidiary in another country;

·       workforce uncertainty in countries where labor unrest is more common than in the United States;

·       production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

·       business interruptions resulting from geo-political actions, including war and terrorism.

These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.

"RISKS ASSOCIATED WITH OUR INTERNATIONAL BUSINESS RELATIONSHIPS COULD MATERIALLY ADVERSELY AFFECT OUR BUSINESS." elsewhere:

ViroPharma (VPHM)
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